Where did your data go?
This page shows only 'generic' information because you are not logged in. If you were using NHS Login, e.g. via the NHS App, this page could be customised to show you the datasets in which information from your own medical records was included.
The list below currently only covers some national data programmes. There are others that you should have been told about, if your information is in them — but probably weren't — and your data may also have been taken from your local Shared Care Record, without you being made aware or having a practical choice.
Technical note: it is now clear that mixing health and non-health projects like makes little sense to others. They'll be split in due course (ideas on how welcome!)New Projects by first known date
Because some data providers choose to keep projects secret for over 3 months, new projects may appear in long past months
Unknown date
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Discharge Modelling — NHS England in Palantir...
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Discharge Modelling
why: Recovery of Critical Services
what: Discharge Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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COVID Vaccine: Regional Vaccine Readiness and Workforce â South West — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â South West
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Public Data Landing — NHS England in Palantir...
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Public Data Landing
why: System Admin
what: Public Data Landing
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Hypertension related Emergency Department Admissions — NHS England in Palantir...
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Hypertension related Emergency Department Admissions
why: Recovery of Critical Services
what: Hypertension related Emergency Department Admissions
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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PPE Distribution South East — NHS England in Palantir...
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PPE Distribution South East
why: Supply Management Capability
what: PPE Distribution South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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PBAC Interface : PROD — NHS England in Palantir...
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PBAC Interface : PROD
why: System Admin
what: PBAC Interface : PROD
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Flu Vaccine: Vaccination Events — NHS England in Palantir...
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Flu Vaccine: Vaccination Events
why: Immunisation and Vaccination Management Capability
what: Flu Vaccine: Vaccination Events
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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COVID Vaccine: National Leadership — NHS England in Palantir...
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COVID Vaccine: National Leadership
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: National Leadership
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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GUM Vaccination Reporting — NHS England in Palantir...
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GUM Vaccination Reporting
why: Immunisation and Vaccination Management Capability
what: GUM Vaccination Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Chelsea Westminster Demo — NHS England in Palantir...
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Chelsea Westminster Demo
why: System Admin
what: Chelsea Westminster Demo
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source - and 274 more projects — click to show
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Social Care: Social Care Analytics - Data Export — NHS England in Palantir...
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Social Care: Social Care Analytics - Data Export
why: System Admin
what: Social Care: Social Care Analytics - Data Export
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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System Resilience Products — NHS England in Palantir...
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System Resilience Products
why: Recovery of Critical Services
what: System Resilience Products
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Data Sharing Agreement between NHS England and Digital Health and Care Wales to enable NHS Wales organisations to identify patients who have received a vaccine and to allow for an update to Wales Immunisation (WIS) — NHS England/ NHS Wales...
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Data Sharing Agreement between NHS England and Digital Health and Care Wales to enable NHS Wales organisations to identify patients who have received a vaccine and to allow for an update to Wales Immunisation (WIS)
why: GDPR Article 6 (1) GDPR Article 9 (2)(h)
what: Data Sharing Agreement between NHS England and Digital Health and Care Wales to enable NHS Wales organisations to identify patients who have received a vaccine and to allow for an update to Wales Immunisation (WIS)
who: NHS England/ NHS Wales
where: disseminated
when: unstated
dataset: Personal data is shared by Digital Health and Care Wales to NHS England for the purpose of enabling NHS England to identify patients who have received a vaccination in Wales, and in particular to update the National Immunisation Management Service (NIMS) system to provide GPs in England with the details of Covid-19 vaccinations received by their patients in Wales. Personal data is also shared between NHS England to Digital Health and Care Wales for the purpose of enabling NHS wales organisations to identify patients who have received an immunisation in Wales, and in particular to update the Wales Immunisation Service (WIS) system to provide GPs in Wales with the details of Covid-19 vaccinations received by their patients in England.
optouts: unstated
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Early Warning Detection: Regional - Southeast — NHS England in Palantir...
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Early Warning Detection: Regional - Southeast
why: Early Warning System
what: Early Warning Detection: Regional - Southeast
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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COVID Vaccine: Regional Vaccine Readiness and Workforce â North West — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â North West
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â North West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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NHSE/I HR and OD Workforce Analytics — NHS England in Palantir...
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NHSE/I HR and OD Workforce Analytics
why: Supply Management Capability
what: NHSE/I HR and OD Workforce Analytics
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Discharge Demo — NHS England in Palantir...
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Discharge Demo
why: System Admin
what: Discharge Demo
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Provision of data to the Department of Health and Social Care (or Business Service Authority on their behalf) in order to identify and make contact with employers and families of employees who have yet to make a claim through the NHS and Social Care Coronavirus Life Assurance Scheme — Department of Health and Social Care...
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Provision of data to the Department of Health and Social Care (or Business Service Authority on their behalf) in order to identify and make contact with employers and families of employees who have yet to make a claim through the NHS and Social Care Coronavirus Life Assurance Scheme
why: COPI GDPR Article 6(1)(c) GDPR Article 9(2)(i)
what: Provision of data to the Department of Health and Social Care (or Business Service Authority on their behalf) in order to identify and make contact with employers and families of employees who have yet to make a claim through the NHS and Social Care Coronavirus Life Assurance Scheme
who: Department of Health and Social Care
where: disseminated
when: unstated
dataset: Confidential patient information data including organisation (where death took place),patient name, postcode, and information regarding the employment of staff. This data is used to contact employers and families of staff reported to have died due to Covid-19 as part of the work to maximise take up of Department of Health and Social Care Coronavirus Life Assurance (England) scheme 2020.
optouts: unstated
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Lateral Flow Test Assurance and Intelligence: Regional - South West — NHS England in Palantir...
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Lateral Flow Test Assurance and Intelligence: Regional - South West
why: Immunisation and Vaccination Management Capability
what: Lateral Flow Test Assurance and Intelligence: Regional - South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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ICS Dataset Generator : Anonymised Data — NHS England in Palantir...
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ICS Dataset Generator : Anonymised Data
why: System Admin
what: ICS Dataset Generator : Anonymised Data
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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SofS Winter Dashboard — NHS England in Palantir...
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SofS Winter Dashboard
why: Recovery of Critical Services
what: SofS Winter Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Social Care Local - South East — NHS England in Palantir...
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Social Care Local - South East
why: Workforce Analytics Capability
what: Social Care Local - South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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COVID Vaccine: South West Analytics & Development — NHS England in Palantir...
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COVID Vaccine: South West Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: South West Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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DHSC Data Generator — NHS England in Palantir...
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DHSC Data Generator
why: System Admin
what: DHSC Data Generator
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Recovery of Critical Services Dashboard — NHS England in Palantir...
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Recovery of Critical Services Dashboard
why: Recovery of Critical Services
what: Recovery of Critical Services Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Tableau Integration — NHS England in Palantir...
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Tableau Integration
why: System Admin
what: Tableau Integration
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Ambulance Reporting — NHS England in Palantir...
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Ambulance Reporting
why: Recovery of Critical Services
what: Ambulance Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Early Warning Detection: Regional - London — NHS England in Palantir...
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Early Warning Detection: Regional - London
why: Early Warning System
what: Early Warning Detection: Regional - London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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IS Sitrep Reporting — NHS England in Palantir...
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IS Sitrep Reporting
why: Workforce Analytics Capability
what: IS Sitrep Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Provision of vaccination data to Public Health England to share vaccination data with Medicines and Healthcare products Regulatory Agency this is required to record who has been vaccinated and if any adverse reactions have occurred — Medicines and Healthcare products Regulatory Agency...
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Provision of vaccination data to Public Health England to share vaccination data with Medicines and Healthcare products Regulatory Agency this is required to record who has been vaccinated and if any adverse reactions have occurred
why: COPI GDPR Article 6(1)(c) GDPR Article 9(2)(i)
what: Provision of vaccination data to Public Health England to share vaccination data with Medicines and Healthcare products Regulatory Agency this is required to record who has been vaccinated and if any adverse reactions have occurred
who: Medicines and Healthcare products Regulatory Agency
where: disseminated
when: unstated
dataset: Pseudonymised data includes patient ID, practice ID, type of reaction, recorded date and data relevant to the adverse reaction and vaccination. The vaccination data is required to ensure that Medicines and Healthcare products Regulatory Agency (MHRA) know who has been vaccinated. This enables MHRA to assess changes in health outcomes compared to the general population who have not been vaccinated. The adverse reactions data is information on any adverse reactions reported at a point of care of the vaccination.
optouts: unstated
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Workforce Ontology — NHS England in Palantir...
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Workforce Ontology
why: System Admin
what: Workforce Ontology
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Social Care Local - South West — NHS England in Palantir...
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Social Care Local - South West
why: Workforce Analytics Capability
what: Social Care Local - South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Provision of data to NHS Manx (Isle of Man) to ensure the latest vaccination data is available in IoM citizens GP records. — NHS Manx...
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Provision of data to NHS Manx (Isle of Man) to ensure the latest vaccination data is available in IoM citizens GP records.
why: GDPR Article 6 (1)(c) GDPR Article 9 (2)(i)
what: Provision of data to NHS Manx (Isle of Man) to ensure the latest vaccination data is available in IoM citizens GP records.
who: NHS Manx
where: disseminated
when: unstated
dataset: Confidential Patient Information including recorded data, NHS number, local identification and care setting. The provision of vaccination data is required for cross border citizens who have been vaccinated in England but are resident in IoM or registered with a GP in IoM. This is to ensure that vaccination records are accurate and up-to-date.
optouts: unstated
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ICS Planning Support - McKinzey — NHS England in Palantir...
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ICS Planning Support - McKinzey
why: Workforce Analytics Capability
what: ICS Planning Support - McKinzey
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Early Warning Detection: Regional - Northeast and Yorkshire — NHS England in Palantir...
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Early Warning Detection: Regional - Northeast and Yorkshire
why: Early Warning System
what: Early Warning Detection: Regional - Northeast and Yorkshire
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit — NHS England in Palantir...
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EU Exit
why: Workforce Analytics Capability
what: EU Exit
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
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Bed Occupancy Breach Modelling — NHS England in Palantir...
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Bed Occupancy Breach Modelling
why: Recovery of Critical Services
what: Bed Occupancy Breach Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Patient Ontology Beta Release — NHS England in Palantir...
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Patient Ontology Beta Release
why: System Admin
what: Patient Ontology Beta Release
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Access Materials (Public) — NHS England in Palantir...
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Access Materials (Public)
why: System Admin
what: Access Materials (Public)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Processing of imaging data to create a National COVID-19 Database (NCCID) of Chest X-ray , Computed Tomography (CT) and Magnetic Response (MR) images and other relevant patient information which enables the development of automated analysis technologies to support COVID-19 care pathways and accelerates research projects to which will enable the best care for patients hospitalised with a severe infection. — Department of Health and Social Care / NHS X/ Royal Surrey Foundation Trust...
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Processing of imaging data to create a National COVID-19 Database (NCCID) of Chest X-ray , Computed Tomography (CT) and Magnetic Response (MR) images and other relevant patient information which enables the development of automated analysis technologies to support COVID-19 care pathways and accelerates research projects to which will enable the best care for patients hospitalised with a severe infection.
why: COPI GDPR Article 6(1)(e) GDPR Article 9(2)(i)
what: Processing of imaging data to create a National COVID-19 Database (NCCID) of Chest X-ray , Computed Tomography (CT) and Magnetic Response (MR) images and other relevant patient information which enables the development of automated analysis technologies to support COVID-19 care pathways and accelerates research projects to which will enable the best care for patients hospitalised with a severe infection.
who: Department of Health and Social Care / NHS X/ Royal Surrey Foundation Trust
where: disseminated
when: unstated
dataset: Identifiable patient level data including age, gender, NHS number and clinical information. NHSX are creating a national database of chest X-ray, CT and MR images and other relevant patient information that enables the development of automated analysis technologies which may prove effective in supporting COVID-19 care pathways, and to accelerate research projects to better understand COVID-19. This information will be accessed by healthcare staff.
optouts: unstated
Source -
Breast Cancer Screening Restoration — NHS England in Palantir...
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Breast Cancer Screening Restoration
why: Recovery of Critical Services
what: Breast Cancer Screening Restoration
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Midlands Analytics & Development — NHS England in Palantir...
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COVID Vaccine: Midlands Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Midlands Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Pseudo-Engine-NCDR — NHS England in Palantir...
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Pseudo-Engine-NCDR
why: System Admin
what: Pseudo-Engine-NCDR
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Vivaldi — NHS England in Palantir...
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Vivaldi
why: Workforce Analytics Capability
what: Vivaldi
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National Strategic Dashboard — NHS England in Palantir...
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National Strategic Dashboard
why: Strategic Decision-Makers Dashboard
what: National Strategic Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
CCS Export — NHS England in Palantir...
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CCS Export
why: System Admin
what: CCS Export
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Beds Summary Development — NHS England in Palantir...
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Beds Summary Development
why: Recovery of Critical Services
what: Beds Summary Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Metrics Ontology — NHS England in Palantir...
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Metrics Ontology
why: System Admin
what: Metrics Ontology
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - North West — NHS England in Palantir...
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Social Care Local - North West
why: Workforce Analytics Capability
what: Social Care Local - North West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Early Warning Detection — NHS England in Palantir...
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Early Warning Detection
why: Early Warning System
what: Early Warning Detection
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Vaccine Readiness and Workforce â East of England — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â East of England
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
NHS and IS Weekly Activity Core Data — NHS England in Palantir...
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NHS and IS Weekly Activity Core Data
why: Workforce Analytics Capability
what: NHS and IS Weekly Activity Core Data
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Place Ontology — NHS England in Palantir...
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Place Ontology
why: System Admin
what: Place Ontology
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Testing — NHS England in Palantir...
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Testing
why: System Admin
what: Testing
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Post COVID Assessment Clinic Data — NHS England in Palantir...
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Post COVID Assessment Clinic Data
why: Workforce Analytics Capability
what: Post COVID Assessment Clinic Data
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
RCS Dashboard Sub-Regional Data - National — NHS England in Palantir...
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RCS Dashboard Sub-Regional Data - National
why: Recovery of Critical Services
what: RCS Dashboard Sub-Regional Data - National
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Vaccine Readiness and Workforce â South East — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â South East
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Medical Supply-Chain Data and Analytics — NHS England in Palantir...
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Medical Supply-Chain Data and Analytics
why: Supply Management Capability
what: Medical Supply-Chain Data and Analytics
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Global Vaccine Confidence Campaign — NHS England in Palantir...
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Global Vaccine Confidence Campaign
why: Immunisation and Vaccination Management Capability
what: Global Vaccine Confidence Campaign
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: East of England Analytics & Development — NHS England in Palantir...
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COVID Vaccine: East of England Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: East of England Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of Immunoglobulin data held by NHS England behalf of Trusts to Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) to enable the collection of relevant data to urgently determine the safety of the COVID Vaccination programme which is being rolled out at pace — Public Health England...
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Provision of Immunoglobulin data held by NHS England behalf of Trusts to Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) to enable the collection of relevant data to urgently determine the safety of the COVID Vaccination programme which is being rolled out at pace
why: COPI GDPR Article 6 (1)(c) GDPR Article 9 (2)(i)
what: Provision of Immunoglobulin data held by NHS England behalf of Trusts to Public Health England (PHE) and Medicines and Healthcare products Regulatory Agency (MHRA) to enable the collection of relevant data to urgently determine the safety of the COVID Vaccination programme which is being rolled out at pace
who: Public Health England Medicines and Healthcare products Regulatory Agency
where: disseminated
when: unstated
dataset: Confidential Patient information including NHS number, Gender, Date of Birth and clinical information. Public Health England (PHE) and the Medicines Health and Regulatory Authority (MHRA) require the requested Intravenous Immunoglobulin (IVIG) data to enable the collection of relevant data to urgently determine the safety of the COVID Vaccination programme which is being rolled out at pace. Analysis of this data will be used combination with analysis of other relevant data to inform the future of the whole programme.
optouts: unstated
Source -
Elective Recovery Fund — NHS England in Palantir...
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Elective Recovery Fund
why: Recovery of Critical Services
what: Elective Recovery Fund
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Mental Health Core Data — NHS England in Palantir...
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Mental Health Core Data
why: Recovery of Critical Services
what: Mental Health Core Data
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Midlands ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: Midlands ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Midlands ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Lateral Flow Test Assurance and Intelligence — NHS England in Palantir...
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Lateral Flow Test Assurance and Intelligence
why: Immunisation and Vaccination Management Capability
what: Lateral Flow Test Assurance and Intelligence
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Post COPI Preparation — NHS England in Palantir...
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Post COPI Preparation
why: System Admin
what: Post COPI Preparation
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: LVS Workspace — NHS England in Palantir...
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COVID Vaccine: LVS Workspace
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: LVS Workspace
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Palantir Pipeline Monitors — NHS England in Palantir...
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Palantir Pipeline Monitors
why: System Admin
what: Palantir Pipeline Monitors
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: South East Analytics & Development — NHS England in Palantir...
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COVID Vaccine: South East Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: South East Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - South West — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - South West
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - East of England — NHS England in Palantir...
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Social Care Local - East of England
why: Workforce Analytics Capability
what: Social Care Local - East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
HR Strategic Dashboard — NHS England in Palantir...
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HR Strategic Dashboard
why: Workforce Analytics Capability
what: HR Strategic Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: North East and Yorkshire Analytics & Development — NHS England in Palantir...
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COVID Vaccine: North East and Yorkshire Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: North East and Yorkshire Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
A&E Admissions Forecasting Tool — NHS England in Palantir...
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A&E Admissions Forecasting Tool
why: Recovery of Critical Services
what: A&E Admissions Forecasting Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: Region - North East and Yorkshire — NHS England in Palantir...
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EU Exit: Region - North East and Yorkshire
why: Workforce Analytics Capability
what: EU Exit: Region - North East and Yorkshire
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
A&E Risk Likelihood Modelling — NHS England in Palantir...
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A&E Risk Likelihood Modelling
why: Recovery of Critical Services
what: A&E Risk Likelihood Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - East of England — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - East of England
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Test Purpose (No Data) — NHS England in Palantir...
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Test Purpose (No Data)
why: System Admin
what: Test Purpose (No Data)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Anticipatory Care planning dashboard — NHS England in Palantir...
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Anticipatory Care planning dashboard
why: Recovery of Critical Services
what: Anticipatory Care planning dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of vaccination data to the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) - University of Liverpool, University of Edinburgh and University of Oxford. The information gathered is essential to help health service planning and provision, and to rapidly evaluate the impact of interventions such as new therapeutics or vaccines — International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)...
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Provision of vaccination data to the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) - University of Liverpool, University of Edinburgh and University of Oxford. The information gathered is essential to help health service planning and provision, and to rapidly evaluate the impact of interventions such as new therapeutics or vaccines
why: COPI GDPR Article 6(1)(e) GDPR Article 9(2)(j)
what: Provision of vaccination data to the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) - University of Liverpool, University of Edinburgh and University of Oxford. The information gathered is essential to help health service planning and provision, and to rapidly evaluate the impact of interventions such as new therapeutics or vaccines
who: International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)
where: disseminated
when: unstated
dataset: Confidential Patient information including NHS number, age, gender and vaccination data . Is used by the Coronavirus Clinical Information Network (CO-CIN) has collected data for the International Severe Acute Respiratory Infection Consortium (ISARIC) through a commission from the Chief Medical Officer to conduct Urgent Public Health Research to provide evidence that informs public health policy in response to the COVID-19 emergency.
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan v. Actual - National — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan v. Actual - National
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan v. Actual - National
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Worcestershire Acute - Commercial and Spend Analytics — NHS England in Palantir...
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Worcestershire Acute - Commercial and Spend Analytics
why: Workforce Analytics Capability
what: Worcestershire Acute - Commercial and Spend Analytics
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
DHSC Data Sharing Workspace — NHS England in Palantir...
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DHSC Data Sharing Workspace
why: System Admin
what: DHSC Data Sharing Workspace
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Vaccine Readiness and Workforce â London — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â London
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
DHSC UEC Data Export — NHS England in Palantir...
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DHSC UEC Data Export
why: System Admin
what: DHSC UEC Data Export
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of data to the Oxford Data Lab and London School of Tropical Medicine for research purposes to identify medical conditions and medications that affect the risk or impact of Covid-19 infection on individuals — Oxford Data Lab/London School of Tropical Medicine...
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Provision of data to the Oxford Data Lab and London School of Tropical Medicine for research purposes to identify medical conditions and medications that affect the risk or impact of Covid-19 infection on individuals
why: COPI
what: Provision of data to the Oxford Data Lab and London School of Tropical Medicine for research purposes to identify medical conditions and medications that affect the risk or impact of Covid-19 infection on individuals
who: Oxford Data Lab/London School of Tropical Medicine
where: disseminated
when: unstated
dataset: Pseudonymised patient level data including clinical information, demographic data e.g. partial postcode geographic super-output area codes, date of birth (MM/CCYY) and date of death (MM/CCYY). The data is required to identify medical conditions and medications that affect the risk or impact of Covid-19 infection on individuals; this will assist with identifying risk factors associated with poor patient outcomes as well as information to monitor and predict demand on health services. This is being achieved by linking patient level data from the COVID-19 Hospitalisation in England Surveillance System (CHESS), Intensive Care National Audit and Research Centre (ICNARC) and other NHS intensive care or relevant datasets with GP patients records to support data analysis by Oxford University EBM Data Lab and London School of Hygiene and Tropical Medicine (LSHTM) EHR research group.
optouts: unstated
Source -
COVID Vaccine: Regional Vaccine Readiness and Workforce â Midlands — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â Midlands
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: East of England ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: East of England ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: East of England ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care: Social Care Project Team — NHS England in Palantir...
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Social Care: Social Care Project Team
why: System Admin
what: Social Care: Social Care Project Team
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: London Analytics & Development — NHS England in Palantir...
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COVID Vaccine: London Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: London Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Community Services Datasets (CSDS) — NHS England in Palantir...
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Community Services Datasets (CSDS)
why: Workforce Analytics Capability
what: Community Services Datasets (CSDS)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: South West — NHS England in Palantir...
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EU Exit: South West
why: Workforce Analytics Capability
what: EU Exit: South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Adult Frailty Score — NHS England in Palantir...
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Adult Frailty Score
why: Recovery of Critical Services
what: Adult Frailty Score
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Urgent & Emergency Care Dashboard — NHS England in Palantir...
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Urgent & Emergency Care Dashboard
why: Recovery of Critical Services
what: Urgent & Emergency Care Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Planning Support - PwC — NHS England in Palantir...
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ICS Planning Support - PwC
why: Workforce Analytics Capability
what: ICS Planning Support - PwC
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Early Warning Modelling — NHS England in Palantir...
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Early Warning Modelling
why: Early Warning System
what: Early Warning Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Training Resources (Admin) — NHS England in Palantir...
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Training Resources (Admin)
why: System Admin
what: Training Resources (Admin)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Early Warning Detection: Regional - Southwest Region — NHS England in Palantir...
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Early Warning Detection: Regional - Southwest Region
why: Early Warning System
what: Early Warning Detection: Regional - Southwest Region
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PPE Distribution South West — NHS England in Palantir...
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PPE Distribution South West
why: Supply Management Capability
what: PPE Distribution South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Patient Level Costing System (PLICS) — NHS England in Palantir...
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Patient Level Costing System (PLICS)
why: Workforce Analytics Capability
what: Patient Level Costing System (PLICS)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Faster Data Flows Engineering Test — NHS England in Palantir...
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Faster Data Flows Engineering Test
why: System Admin
what: Faster Data Flows Engineering Test
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of vaccination data to the Joint Bio-security Centre (JBC) team in Department of Health and Social Care (DHSC). The Joint-Bio Security (JBC) combine epidemiological expertise and analytical capability to provide analysis and insight on the status of the COVID-19 epidemic in the UK as well as the drivers and risk factors of transmission. Use of this data supports decision-makers at a local and national level to take effective action to break the chains of transmission, and in turn, protect the public. The JBC also collects, collates and analyses data, which it uses to advise the Chief Medical Officers on appropriate alert levels. Further information regarding the JBC, its role and its use of data is available at https://www.gov.uk/government/groups/joint-biosecurity-centre#about-the-jbc — Department of Health and Social Care...
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Provision of vaccination data to the Joint Bio-security Centre (JBC) team in Department of Health and Social Care (DHSC). The Joint-Bio Security (JBC) combine epidemiological expertise and analytical capability to provide analysis and insight on the status of the COVID-19 epidemic in the UK as well as the drivers and risk factors of transmission. Use of this data supports decision-makers at a local and national level to take effective action to break the chains of transmission, and in turn, protect the public. The JBC also collects, collates and analyses data, which it uses to advise the Chief Medical Officers on appropriate alert levels. Further information regarding the JBC, its role and its use of data is available at https://www.gov.uk/government/groups/joint-biosecurity-centre#about-the-jbc
why: COPI GDPR Article 6(1)(c) GDPR Article 9(2)(i)
what: Provision of vaccination data to the Joint Bio-security Centre (JBC) team in Department of Health and Social Care (DHSC). The Joint-Bio Security (JBC) combine epidemiological expertise and analytical capability to provide analysis and insight on the status of the COVID-19 epidemic in the UK as well as the drivers and risk factors of transmission. Use of this data supports decision-makers at a local and national level to take effective action to break the chains of transmission, and in turn, protect the public. The JBC also collects, collates and analyses data, which it uses to advise the Chief Medical Officers on appropriate alert levels. Further information regarding the JBC, its role and its use of data is available at https://www.gov.uk/government/groups/joint-biosecurity-centre#about-the-jbc
who: Department of Health and Social Care
where: disseminated
when: unstated
dataset: Confidential information including NHS Number, age, gender, vaccination details (e.g. product and batch) and high level residence location (not postcode).The Joint-Bio Security (JBC) is a directorate of the Department of Health and Social Care (DHSC), combining epidemiological expertise and analytical capability to provide analysis and insight on the status of the COVID-19 epidemic in the UK as well as the drivers and risk factors of transmission. Use of this data supports decision-makers at a local and national level to take effective action to break the chains of transmission, and in turn, protect the public. The JBC also collects, collates and analyses data, which it uses to advise the Chief Medical Officers on appropriate alert levels. Further information regarding the JBC, its role and its use of data is available at https://www.gov.uk/government/groups/joint-biosecurity-centre#about-the-jbc
optouts: unstated
Source -
Foundry Insights and Analysis Team (FIAT) — NHS England in Palantir...
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Foundry Insights and Analysis Team (FIAT)
why: Workforce Analytics Capability
what: Foundry Insights and Analysis Team (FIAT)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Mobility Analysis — NHS England in Palantir...
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Mobility Analysis
why: Recovery of Critical Services
what: Mobility Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Elective Recovery Oversight — NHS England in Palantir...
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Elective Recovery Oversight
why: Recovery of Critical Services
what: Elective Recovery Oversight
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Talent Management Collection — NHS England in Palantir...
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Talent Management Collection
why: Workforce Analytics Capability
what: Talent Management Collection
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Planned Care Tool Project — NHS England in Palantir...
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Planned Care Tool Project
why: Recovery of Critical Services
what: Planned Care Tool Project
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Oxford COVID Model — NHS England in Palantir...
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Oxford COVID Model
why: Workforce Analytics Capability
what: Oxford COVID Model
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of vaccination data to Public Health England (PHE) from the National Immunisation Management Service — Public Health England...
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Provision of vaccination data to Public Health England (PHE) from the National Immunisation Management Service
why: COPI GDPR Article 6(1)(e) GDPR Article 9(2)(i)
what: Provision of vaccination data to Public Health England (PHE) from the National Immunisation Management Service
who: Public Health England
where: disseminated
when: unstated
dataset: Confidential Patient Information includes NHS Number, age, gender, vaccination details (e.g. product and batch) and high level residence location (not postcode).Public Health England (PHE) has a role to monitor vaccine coverage, vaccine safety and vaccine failures and vaccine effectiveness Identifiable individual level data is required for vaccine failures and individuals will be identified based on positive test results soon after a vaccination therefore this data will be linked to test result data by PHE. Those who have had a vaccine failure need to be followed up quickly to establish if there has been mild disease or if there are any trends in those who experience vaccine failures.
optouts: unstated
Source -
Flu Vaccine: National Operations — NHS England in Palantir...
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Flu Vaccine: National Operations
why: Immunisation and Vaccination Management Capability
what: Flu Vaccine: National Operations
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICCPP Demonstration — NHS England in Palantir...
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ICCPP Demonstration
why: Recovery of Critical Services
what: ICCPP Demonstration
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Planning Support - KPMG — NHS England in Palantir...
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ICS Planning Support - KPMG
why: Workforce Analytics Capability
what: ICS Planning Support - KPMG
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Discharge Pathway Model — NHS England in Palantir...
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Discharge Pathway Model
why: Recovery of Critical Services
what: Discharge Pathway Model
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
52 Week Waiters — NHS England in Palantir...
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52 Week Waiters
why: Recovery of Critical Services
what: 52 Week Waiters
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Vaccine Readiness and Workforce â North East and Yorkshire — NHS England in Palantir...
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COVID Vaccine: Regional Vaccine Readiness and Workforce â North East and Yorkshire
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Vaccine Readiness and Workforce â North East and Yorkshire
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Independent Sector Activity — NHS England in Palantir...
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Independent Sector Activity
why: Recovery of Critical Services
what: Independent Sector Activity
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
RCS Dashboard Sub-Regional Data - South — NHS England in Palantir...
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RCS Dashboard Sub-Regional Data - South
why: Recovery of Critical Services
what: RCS Dashboard Sub-Regional Data - South
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Critical Equipment Supply Chain — NHS England in Palantir...
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Critical Equipment Supply Chain
why: Supply Management Capability
what: Critical Equipment Supply Chain
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Early Diagnosis of Cancer — NHS England in Palantir...
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Early Diagnosis of Cancer
why: Recovery of Critical Services
what: Early Diagnosis of Cancer
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Usage and Audit Logs — NHS England in Palantir...
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Usage and Audit Logs
why: System Admin
what: Usage and Audit Logs
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: National Vaccine Readiness and Workforce — NHS England in Palantir...
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COVID Vaccine: National Vaccine Readiness and Workforce
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: National Vaccine Readiness and Workforce
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Workspace — NHS England in Palantir...
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ICS Workspace
why: Workforce Analytics Capability
what: ICS Workspace
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Foundry Programme Management — NHS England in Palantir...
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Foundry Programme Management
why: System Admin
what: Foundry Programme Management
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID19 Admission Risk Segmentation Model — NHS England in Palantir...
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COVID19 Admission Risk Segmentation Model
why: Workforce Analytics Capability
what: COVID19 Admission Risk Segmentation Model
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: Region - South East — NHS England in Palantir...
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EU Exit: Region - South East
why: Workforce Analytics Capability
what: EU Exit: Region - South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National PPE Distribution — NHS England in Palantir...
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National PPE Distribution
why: Supply Management Capability
what: National PPE Distribution
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[DEPRECATED] JBC — NHS England in Palantir...
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[DEPRECATED] JBC
why: System Admin
what: [DEPRECATED] JBC
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of data to NHS Scotland to ensure the latest vaccination data is received into GP systems for Scottish residents and is available in citizens GP records. — NHS Scotland...
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Provision of data to NHS Scotland to ensure the latest vaccination data is received into GP systems for Scottish residents and is available in citizens GP records.
why: GDPR Article 6 (1)(c) GDPR Article 9 (2)(i)
what: Provision of data to NHS Scotland to ensure the latest vaccination data is received into GP systems for Scottish residents and is available in citizens GP records.
who: NHS Scotland
where: disseminated
when: unstated
dataset: Confidential Patient information including recorded data, NHS number, local identification and care setting. The provision of vaccination data is required for cross border citizens who have been vaccinated in England but are resident in Scotland or registered with a GP in Scotland. This is to ensure that vaccination records are accurate and up-to-date.
optouts: unstated
Source -
Lateral Flow Test Assurance and Intelligence: Regional - South East — NHS England in Palantir...
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Lateral Flow Test Assurance and Intelligence: Regional - South East
why: Immunisation and Vaccination Management Capability
what: Lateral Flow Test Assurance and Intelligence: Regional - South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Resources (Public) — NHS England in Palantir...
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Resources (Public)
why: System Admin
what: Resources (Public)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Elective Recovery Board — NHS England in Palantir...
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Elective Recovery Board
why: Recovery of Critical Services
what: Elective Recovery Board
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Performance Analytics Team — NHS England in Palantir...
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Performance Analytics Team
why: System Admin
what: Performance Analytics Team
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Ingest Monitoring : NWAS 15-minute Ambulance Feed — NHS England in Palantir...
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Ingest Monitoring : NWAS 15-minute Ambulance Feed
why: Recovery of Critical Services
what: Ingest Monitoring : NWAS 15-minute Ambulance Feed
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Long COVID Modelling — NHS England in Palantir...
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Long COVID Modelling
why: Workforce Analytics Capability
what: Long COVID Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Care Quality Commission Data Egress — NHS England in Palantir...
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Care Quality Commission Data Egress
why: System Admin
what: Care Quality Commission Data Egress
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: South East ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: South East ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: South East ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Workforce Capacity Modelling — NHS England in Palantir...
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Workforce Capacity Modelling
why: Workforce Analytics Capability
what: Workforce Capacity Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Places Development — NHS England in Palantir...
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Places Development
why: System Admin
what: Places Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: London ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: London ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: London ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
MSOA Maps — NHS England in Palantir...
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MSOA Maps
why: System Admin
what: MSOA Maps
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: Region - Midlands — NHS England in Palantir...
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EU Exit: Region - Midlands
why: Workforce Analytics Capability
what: EU Exit: Region - Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Sharing of vaccination data between NHSE and the Department of Health & Social Care (DHSC) to support development of Covid Certificates. — Department of Health and Social Care...
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Sharing of vaccination data between NHSE and the Department of Health & Social Care (DHSC) to support development of Covid Certificates.
why: COPI GDPR Article 6(1)(e) GDPR Article 9 (2)(h) GDPR Article 9 (2)(j) DPA2018 Schedule Part 1 para.3 public health
what: Sharing of vaccination data between NHSE and the Department of Health & Social Care (DHSC) to support development of Covid Certificates.
who: Department of Health and Social Care
where: disseminated
when: unstated
dataset: Confidential patient information including date of birth , ethnicity, patient name, patient postcode, gender and vaccination details (e.g. product and batch) . Department of Health and Social Care are developing a digital vaccine certificate and need to trial the system provided by their data processor organisation to assess feasibility. Data subjects involved in the trial are from one NHS organisation and consent to their information being provided for trial purposes.
optouts: unstated
Source -
System Recovery Tool — NHS England in Palantir...
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System Recovery Tool
why: Recovery of Critical Services
what: System Recovery Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Improving Care Coordination for Patients Programme — NHS England in Palantir...
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Improving Care Coordination for Patients Programme
why: Recovery of Critical Services
what: Improving Care Coordination for Patients Programme
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PPE Distribution North East and Yorkshire — NHS England in Palantir...
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PPE Distribution North East and Yorkshire
why: Supply Management Capability
what: PPE Distribution North East and Yorkshire
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Discharge Visibility — NHS England in Palantir...
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Discharge Visibility
why: Recovery of Critical Services
what: Discharge Visibility
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - London — NHS England in Palantir...
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Social Care Local - London
why: Workforce Analytics Capability
what: Social Care Local - London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Infection and AMR Linkage <NCDR pseudo> — NHS England in Palantir...
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Infection and AMR Linkage <NCDR pseudo>
why: Workforce Analytics Capability
what: Infection and AMR Linkage <NCDR pseudo>
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - North West — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - North West
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - North West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Beds Summary Products — NHS England in Palantir...
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Beds Summary Products
why: Recovery of Critical Services
what: Beds Summary Products
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Data Export for HMT — NHS England in Palantir...
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Data Export for HMT
why: System Admin
what: Data Export for HMT
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
NHSEI Analytics Blueprint — NHS England in Palantir...
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NHSEI Analytics Blueprint
why: Workforce Analytics Capability
what: NHSEI Analytics Blueprint
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - Yorkshire and The Humber — NHS England in Palantir...
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Social Care Local - Yorkshire and The Humber
why: Workforce Analytics Capability
what: Social Care Local - Yorkshire and The Humber
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Foundry Control Panel — NHS England in Palantir...
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Foundry Control Panel
why: System Admin
what: Foundry Control Panel
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Covid-19 testing â analysis and reporting (UKHSA SGSS data) — NHS England in Palantir...
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Covid-19 testing â analysis and reporting (UKHSA SGSS data)
why: Workforce Analytics Capability
what: Covid-19 testing â analysis and reporting (UKHSA SGSS data)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of demographic data to NHS Digital regarding COVID-19 household level tracking method for outbreak of COVID-19 and looking at transmissions — NHS Digital...
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Provision of demographic data to NHS Digital regarding COVID-19 household level tracking method for outbreak of COVID-19 and looking at transmissions
why: COVID-19 Public Health Directions 2020 Health and Social Care Act 2012 GDPR Article 6 (1)(c) GDPR Article 9 (2)(i)
what: Provision of demographic data to NHS Digital regarding COVID-19 household level tracking method for outbreak of COVID-19 and looking at transmissions
who: NHS Digital
where: disseminated
when: unstated
dataset: Confidential Patient Information includes NHS Number, Postcode, Care Home Flag, Care Home Identity and information relating to the Care home. NHS Digital are developing a household level tracking method for outbreaks of COVID- 19 and looking at COVID transmission within the household based on different types of household compositions, e.g. the presence of children of different ages, property types and ethnicity etc. The data will be used to undertake internal analysis, linkage and dissemination of data to Public Health England (PHE).
optouts: unstated
Source -
111 First — NHS England in Palantir...
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111 First
why: Recovery of Critical Services
what: 111 First
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Theatre Productivity Metrics Development — NHS England in Palantir...
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Theatre Productivity Metrics Development
why: System Admin
what: Theatre Productivity Metrics Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Planning Support - Deloitte — NHS England in Palantir...
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ICS Planning Support - Deloitte
why: Workforce Analytics Capability
what: ICS Planning Support - Deloitte
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Early Warning Detection: Regional - East of England — NHS England in Palantir...
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Early Warning Detection: Regional - East of England
why: Early Warning System
what: Early Warning Detection: Regional - East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: North East and Yorkshire ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: North East and Yorkshire ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: North East and Yorkshire ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of updated demographic data to the Fire and Rescue Service (FRS ) to deliver Home Fire Safety Checks (HSFC) to reduce death and injuries in fires and also to support the collaborative work on COVID — Fire and Rescue Services (England)...
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Provision of updated demographic data to the Fire and Rescue Service (FRS ) to deliver Home Fire Safety Checks (HSFC) to reduce death and injuries in fires and also to support the collaborative work on COVID
why: COPI GDPR Article 6(1)(e) Health and Social Care Act 2012
what: Provision of updated demographic data to the Fire and Rescue Service (FRS ) to deliver Home Fire Safety Checks (HSFC) to reduce death and injuries in fires and also to support the collaborative work on COVID
who: Fire and Rescue Services (England)
where: disseminated
when: unstated
dataset: The FRS receive Address, Year of Birth (only if over 65), Gender, Frailty Flag and NHS Number which supports them to target vulnerable citizens who are at a higher risk of injury or death from fire. As part of the collaborative work in supporting the response to COVID, NHS numbers are also required to enable the FRS to match the Unique Property Reference Number to the shield list that they already hold on citizens, and enable the linkage of shield list to other datasets held by the FRS/tactical/strategic commands to support COVID19 purposes.
optouts: unstated
Source -
Demand Forecast Objective — NHS England in Palantir...
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Demand Forecast Objective
why: Early Warning System
what: Demand Forecast Objective
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Workforce Supply & Demand Modelling — NHS England in Palantir...
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Workforce Supply & Demand Modelling
why: Supply Management Capability
what: Workforce Supply & Demand Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: Region - North West — NHS England in Palantir...
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EU Exit: Region - North West
why: Workforce Analytics Capability
what: EU Exit: Region - North West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care National - Granular — NHS England in Palantir...
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Social Care National - Granular
why: Workforce Analytics Capability
what: Social Care National - Granular
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated] Palantir Developers — NHS England in Palantir...
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[Deprecated] Palantir Developers
why: System Admin
what: [Deprecated] Palantir Developers
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs Actual - London — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs Actual - London
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs Actual - London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National Elective Recovery Modelling — NHS England in Palantir...
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National Elective Recovery Modelling
why: Recovery of Critical Services
what: National Elective Recovery Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Health Inequalities — NHS England in Palantir...
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Health Inequalities
why: Recovery of Critical Services
what: Health Inequalities
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of NHS numbers for a COVID research study which the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) are undertaking. — International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)...
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Provision of NHS numbers for a COVID research study which the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) are undertaking.
why: COPI Article 6(1)(c) GDPR Article 9(2)(j)
what: Provision of NHS numbers for a COVID research study which the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) are undertaking.
who: International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)
where: disseminated
when: unstated
dataset: The requirement is to disclose the NHS numbers of COVID positive patients that have been prescribed Remdesivir in the treatment of COVID-19 to Oxford University for the purposes of the International Severe Acute Respiratory (ISARIC) 4C Clinical Characterisation Protocol. ISARIC is a nationally prioritised research study on the treatment of COVID-19 with the purpose of aiding clinicians in offering best care and advice to patients with or at risk of COVID-19 across the UK.
optouts: unstated
Source -
RCS Dashboard Sub-Regional Data - London — NHS England in Palantir...
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RCS Dashboard Sub-Regional Data - London
why: Recovery of Critical Services
what: RCS Dashboard Sub-Regional Data - London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National Incident Reporting Board — NHS England in Palantir...
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National Incident Reporting Board
why: Recovery of Critical Services
what: National Incident Reporting Board
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Health Inequalities System Improvement — NHS England in Palantir...
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Health Inequalities System Improvement
why: Recovery of Critical Services
what: Health Inequalities System Improvement
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - London — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - London
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICU Consumables Supply Chain — NHS England in Palantir...
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ICU Consumables Supply Chain
why: Supply Management Capability
what: ICU Consumables Supply Chain
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
NHS Performance Overview (formerly Executive Dashboard) — NHS England in Palantir...
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NHS Performance Overview (formerly Executive Dashboard)
why: Workforce Analytics Capability
what: NHS Performance Overview (formerly Executive Dashboard)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - North East and Yorkshire — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - North East and Yorkshire
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - North East and Yorkshire
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
RCS Dashboard Sub-Regional Data - Central — NHS England in Palantir...
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RCS Dashboard Sub-Regional Data - Central
why: Recovery of Critical Services
what: RCS Dashboard Sub-Regional Data - Central
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Covid Vaccination Centre Management — NHS England in Palantir...
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Covid Vaccination Centre Management
why: Immunisation and Vaccination Management Capability
what: Covid Vaccination Centre Management
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS — NHS England in Palantir...
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ICS
why: Strategic Decision-Makers Dashboard
what: ICS
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
CMDU Reporting — NHS England in Palantir...
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CMDU Reporting
why: Immunisation and Vaccination Management Capability
what: CMDU Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - South West — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - South West
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - South West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of Data Notice to UKHSA (UK Health Security Agency) to monitor drug resistance and the emergence of viral variants in individuals on treatment as part of clinical trails or under published clinical commission policies. This provides a rapid way of identifying clinical severity associated with COVID. — UK Health Security Agency...
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Provision of Data Notice to UKHSA (UK Health Security Agency) to monitor drug resistance and the emergence of viral variants in individuals on treatment as part of clinical trails or under published clinical commission policies. This provides a rapid way of identifying clinical severity associated with COVID.
why: COPI GDPR Article 6(1)(e) GDPR Article 9(2)(j)
what: Provision of Data Notice to UKHSA (UK Health Security Agency) to monitor drug resistance and the emergence of viral variants in individuals on treatment as part of clinical trails or under published clinical commission policies. This provides a rapid way of identifying clinical severity associated with COVID.
who: UK Health Security Agency
where: disseminated
when: unstated
dataset: Data Containing Identifiers including NHS number, Patient Initials, Date of Birth, Drug Name, Clinical Information and Care Setting. This will able UKHSA to identify treated individuals and to link this data with genomic surveillance and clinical outcome data to monitor the development of mutations and variants, monitor the frequency of how therapeutics are used and provide surveillance of COVID new and emerging variants.
optouts: unstated
Source -
Social Care Local — NHS England in Palantir...
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Social Care Local
why: Workforce Analytics Capability
what: Social Care Local
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - South East — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - South East
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Place Management Tool — NHS England in Palantir...
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Place Management Tool
why: System Admin
what: Place Management Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Short-term Forecast Objective — NHS England in Palantir...
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Short-term Forecast Objective
why: Early Warning System
what: Short-term Forecast Objective
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care: Cabinet Office - Data Export — NHS England in Palantir...
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Social Care: Cabinet Office - Data Export
why: System Admin
what: Social Care: Cabinet Office - Data Export
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Breast Cancer Screening Restoration Application — NHS England in Palantir...
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Breast Cancer Screening Restoration Application
why: Recovery of Critical Services
what: Breast Cancer Screening Restoration Application
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - North West — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - North West
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - North West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Planning Support - Newton — NHS England in Palantir...
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ICS Planning Support - Newton
why: Workforce Analytics Capability
what: ICS Planning Support - Newton
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Allocate QA and Development — NHS England in Palantir...
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Allocate QA and Development
why: Workforce Analytics Capability
what: Allocate QA and Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PBAC Interface : TEST — NHS England in Palantir...
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PBAC Interface : TEST
why: System Admin
what: PBAC Interface : TEST
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[TO BE DEPRECATED] Infection and AMR Linkage <Covid pseudo> — NHS England in Palantir...
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[TO BE DEPRECATED] Infection and AMR Linkage <Covid pseudo>
why: System Admin
what: [TO BE DEPRECATED] Infection and AMR Linkage <Covid pseudo>
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Published Data Exploration — NHS England in Palantir...
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Published Data Exploration
why: System Admin
what: Published Data Exploration
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Long Covid — NHS England in Palantir...
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Long Covid
why: Workforce Analytics Capability
what: Long Covid
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Waiting List Minimum Data set (MDS) — NHS England in Palantir...
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Waiting List Minimum Data set (MDS)
why: Workforce Analytics Capability
what: Waiting List Minimum Data set (MDS)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Nightingale Surge Capacity — NHS England in Palantir...
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Nightingale Surge Capacity
why: Recovery of Critical Services
what: Nightingale Surge Capacity
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: Region - East of England — NHS England in Palantir...
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EU Exit: Region - East of England
why: Workforce Analytics Capability
what: EU Exit: Region - East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID and Flu Vaccine: Modelling — NHS England in Palantir...
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COVID and Flu Vaccine: Modelling
why: Immunisation and Vaccination Management Capability
what: COVID and Flu Vaccine: Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Antiviral Reporting — NHS England in Palantir...
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Antiviral Reporting
why: Immunisation and Vaccination Management Capability
what: Antiviral Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Central Support Team — NHS England in Palantir...
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Central Support Team
why: System Admin
what: Central Support Team
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Vaccination Program: Regional Data & Analysis Sharing — NHS England in Palantir...
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Vaccination Program: Regional Data & Analysis Sharing
why: Immunisation and Vaccination Management Capability
what: Vaccination Program: Regional Data & Analysis Sharing
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National Vaccination Analysis — NHS England in Palantir...
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National Vaccination Analysis
why: Immunisation and Vaccination Management Capability
what: National Vaccination Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - West Midlands — NHS England in Palantir...
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Social Care Local - West Midlands
why: Workforce Analytics Capability
what: Social Care Local - West Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Data Export for N10/Cabinet Office — NHS England in Palantir...
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Data Export for N10/Cabinet Office
why: System Admin
what: Data Export for N10/Cabinet Office
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: South West ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: South West ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: South West ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Dataset Generator : Pseudonymised Data — NHS England in Palantir...
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ICS Dataset Generator : Pseudonymised Data
why: System Admin
what: ICS Dataset Generator : Pseudonymised Data
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Respiratory Recovery Dashboard — NHS England in Palantir...
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Respiratory Recovery Dashboard
why: Recovery of Critical Services
what: Respiratory Recovery Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Training Resources (Restricted) — NHS England in Palantir...
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Training Resources (Restricted)
why: System Admin
what: Training Resources (Restricted)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Primary Care Data and Insights Dashboard — NHS England in Palantir...
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Primary Care Data and Insights Dashboard
why: Recovery of Critical Services
what: Primary Care Data and Insights Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PPE Distribution North West — NHS England in Palantir...
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PPE Distribution North West
why: Supply Management Capability
what: PPE Distribution North West
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - Midlands — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - Midlands
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
System Resilience Development — NHS England in Palantir...
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System Resilience Development
why: Recovery of Critical Services
what: System Resilience Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
<PBACi TEST> Health Inequalities System Improvement — NHS England in Palantir...
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<PBACi TEST> Health Inequalities System Improvement
why: System Admin
what: <PBACi TEST> Health Inequalities System Improvement
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
DMIS Sys Admin — NHS England in Palantir...
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DMIS Sys Admin
why: System Admin
what: DMIS Sys Admin
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National PPE Supply Chain — NHS England in Palantir...
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National PPE Supply Chain
why: Supply Management Capability
what: National PPE Supply Chain
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Governance Team — NHS England in Palantir...
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Governance Team
why: System Admin
what: Governance Team
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of mortality data to the Office of National Statistics regarding patients who died with a Covid-19 diagnosis — Office for National Statistics...
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Provision of mortality data to the Office of National Statistics regarding patients who died with a Covid-19 diagnosis
why: COPI GDPR Article 6 (1)(c) GDPR Article 9 (2)(i)
what: Provision of mortality data to the Office of National Statistics regarding patients who died with a Covid-19 diagnosis
who: Office for National Statistics
where: disseminated
when: unstated
dataset: Confidential Patient Information includes location of death, sex, region, date of birth and other information with relation to mortality data. The Office for National Statistics (ONS) require a daily feed of record level mortality data from NHS England/Improvement on patients who died with a Covid-19 diagnosis. This will be used to reconcile the mortality data that ONS receives from the General Registrar.
optouts: unstated
Source -
Vax Analysis - Regional — NHS England in Palantir...
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Vax Analysis - Regional
why: Immunisation and Vaccination Management Capability
what: Vax Analysis - Regional
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Epidemic Spread Objective — NHS England in Palantir...
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Epidemic Spread Objective
why: Early Warning System
what: Epidemic Spread Objective
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Bed Demand Modelling — NHS England in Palantir...
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COVID Bed Demand Modelling
why: Recovery of Critical Services
what: COVID Bed Demand Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Regional PPE Supply Chain — NHS England in Palantir...
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Regional PPE Supply Chain
why: Supply Management Capability
what: Regional PPE Supply Chain
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care National — NHS England in Palantir...
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Social Care National
why: Workforce Analytics Capability
what: Social Care National
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Data Exploration — NHS England in Palantir...
see more
Data Exploration
why: System Admin
what: Data Exploration
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Cancer Reporting — NHS England in Palantir...
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Cancer Reporting
why: Recovery of Critical Services
what: Cancer Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - East of England — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - East of England
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PPE Distribution London — NHS England in Palantir...
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PPE Distribution London
why: Supply Management Capability
what: PPE Distribution London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Strategic Planning Tool App — NHS England in Palantir...
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Strategic Planning Tool App
why: Recovery of Critical Services
what: Strategic Planning Tool App
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
NHS COVID Modelling — NHS England in Palantir...
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NHS COVID Modelling
why: Strategic Decision-Makers Dashboard
what: NHS COVID Modelling
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
ICS Planning Support - GT — NHS England in Palantir...
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ICS Planning Support - GT
why: Workforce Analytics Capability
what: ICS Planning Support - GT
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - North East — NHS England in Palantir...
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Social Care Local - North East
why: Workforce Analytics Capability
what: Social Care Local - North East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care Local - East Midlands — NHS England in Palantir...
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Social Care Local - East Midlands
why: Workforce Analytics Capability
what: Social Care Local - East Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Vaccination Events — NHS England in Palantir...
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COVID Vaccine: Vaccination Events
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Vaccination Events
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - Midlands — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - Midlands
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Person Ontology — NHS England in Palantir...
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Person Ontology
why: System Admin
what: Person Ontology
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated] Health Inequalities Improvement — NHS England in Palantir...
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[Deprecated] Health Inequalities Improvement
why: System Admin
what: [Deprecated] Health Inequalities Improvement
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PPE Distribution Midlands — NHS England in Palantir...
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PPE Distribution Midlands
why: Supply Management Capability
what: PPE Distribution Midlands
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Vaccine Supply Chain — NHS England in Palantir...
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COVID Vaccine: Vaccine Supply Chain
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Vaccine Supply Chain
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Service Desk Operations — NHS England in Palantir...
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Service Desk Operations
why: System Admin
what: Service Desk Operations
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Screening and Immunisation Core Data — NHS England in Palantir...
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Screening and Immunisation Core Data
why: Immunisation and Vaccination Management Capability
what: Screening and Immunisation Core Data
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Surrey and Sussex - Planned Care Model — NHS England in Palantir...
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Surrey and Sussex - Planned Care Model
why: Recovery of Critical Services
what: Surrey and Sussex - Planned Care Model
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Automation Testing — NHS England in Palantir...
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Automation Testing
why: System Admin
what: Automation Testing
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Vaccination Impact Monitoring — NHS England in Palantir...
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Vaccination Impact Monitoring
why: Immunisation and Vaccination Management Capability
what: Vaccination Impact Monitoring
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
NHSE/I HR Operations — NHS England in Palantir...
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NHSE/I HR Operations
why: System Admin
what: NHSE/I HR Operations
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Virtual Ward — NHS England in Palantir...
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Virtual Ward
why: Recovery of Critical Services
what: Virtual Ward
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
DIDS Pre-Publication Dataset — NHS England in Palantir...
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DIDS Pre-Publication Dataset
why: Workforce Analytics Capability
what: DIDS Pre-Publication Dataset
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Platform Administrator — NHS England in Palantir...
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Platform Administrator
why: System Admin
what: Platform Administrator
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
104+ Mutual Aid Analysis — NHS England in Palantir...
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104+ Mutual Aid Analysis
why: Recovery of Critical Services
what: 104+ Mutual Aid Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Data Export for DHSC — NHS England in Palantir...
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Data Export for DHSC
why: System Admin
what: Data Export for DHSC
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Integrated Operational Report — NHS England in Palantir...
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Integrated Operational Report
why: Workforce Analytics Capability
what: Integrated Operational Report
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: North West ICS Level Data & Analysis — NHS England in Palantir...
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COVID Vaccine: North West ICS Level Data & Analysis
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: North West ICS Level Data & Analysis
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Public Dashboard — NHS England in Palantir...
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Public Dashboard
why: Strategic Decision-Makers Dashboard
what: Public Dashboard
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Strategic Planning Tool — NHS England in Palantir...
see more
Strategic Planning Tool
why: Recovery of Critical Services
what: Strategic Planning Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EU Exit: Region - London — NHS England in Palantir...
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EU Exit: Region - London
why: Workforce Analytics Capability
what: EU Exit: Region - London
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: North West Analytics & Development — NHS England in Palantir...
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COVID Vaccine: North West Analytics & Development
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: North West Analytics & Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
111 Reporting — NHS England in Palantir...
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111 Reporting
why: Recovery of Critical Services
what: 111 Reporting
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Patient Pathways Development — NHS England in Palantir...
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Patient Pathways Development
why: Recovery of Critical Services
what: Patient Pathways Development
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
(blank) — NHS England in Palantir...
see more
(blank)
why: System Admin
what: (blank)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
PPE Distribution East of England — NHS England in Palantir...
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PPE Distribution East of England
why: Supply Management Capability
what: PPE Distribution East of England
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of data to enable the Department of Health and Social Care to undertake an informed assessment of the distribution of COVID+ designated âsafeâ facilities across localities in England to ensure there is sufficient capacity in Care Homes for all patients who need them. — Department of Health and Social Care...
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Provision of data to enable the Department of Health and Social Care to undertake an informed assessment of the distribution of COVID+ designated âsafeâ facilities across localities in England to ensure there is sufficient capacity in Care Homes for all patients who need them.
why: COPI GDPR Article 6(1)(c) GDPR Article 9(2)(i)
what: Provision of data to enable the Department of Health and Social Care to undertake an informed assessment of the distribution of COVID+ designated âsafeâ facilities across localities in England to ensure there is sufficient capacity in Care Homes for all patients who need them.
who: Department of Health and Social Care
where: disseminated
when: unstated
dataset: Pseudonymised patient level data including record type, patient age, patient diagnosis (COVID+ or not) including date of diagnosis where applicable â which identifies the number of COVID+ and non-COVID+ patients discharged to care homes by date from 01/01/2020 to 30/06/2020.
optouts: unstated
Source -
RCS Dashboard Sub-Regional Data - North — NHS England in Palantir...
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RCS Dashboard Sub-Regional Data - North
why: Recovery of Critical Services
what: RCS Dashboard Sub-Regional Data - North
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Long Covid Clinic Demand Tool — NHS England in Palantir...
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Long Covid Clinic Demand Tool
why: Workforce Analytics Capability
what: Long Covid Clinic Demand Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Plan vs Actual — NHS England in Palantir...
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Plan vs Actual
why: Workforce Analytics Capability
what: Plan vs Actual
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Data Engineering — NHS England in Palantir...
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Data Engineering
why: System Admin
what: Data Engineering
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Provision of vaccination data to the Office for National statistics (ONS) (Trusted Research Environment (TRE) to link the vaccination data to other data held by the Office National Statistics as approved on a case by case basis. This includes the Community Infection Study (CIS), Population level risk and the Covid-19 risk model. — Office for National Statistics...
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Provision of vaccination data to the Office for National statistics (ONS) (Trusted Research Environment (TRE) to link the vaccination data to other data held by the Office National Statistics as approved on a case by case basis. This includes the Community Infection Study (CIS), Population level risk and the Covid-19 risk model.
why: COPI GDPR Article 6 (1)(c) GDPR Article 9 (2)(i)
what: Provision of vaccination data to the Office for National statistics (ONS) (Trusted Research Environment (TRE) to link the vaccination data to other data held by the Office National Statistics as approved on a case by case basis. This includes the Community Infection Study (CIS), Population level risk and the Covid-19 risk model.
who: Office for National Statistics
where: disseminated
when: unstated
optouts: unstated
Source -
Vaccination Program: Regional Data Development & Engineering — NHS England in Palantir...
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Vaccination Program: Regional Data Development & Engineering
why: Immunisation and Vaccination Management Capability
what: Vaccination Program: Regional Data Development & Engineering
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
EPRR Incident Response — NHS England in Palantir...
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EPRR Incident Response
why: Recovery of Critical Services
what: EPRR Incident Response
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National Diabetes Audit — NHS England in Palantir...
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National Diabetes Audit
why: Recovery of Critical Services
what: National Diabetes Audit
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Integrated Planning Tool — NHS England in Palantir...
see more
Integrated Planning Tool
why: Integrated Planning Tool
what: Integrated Planning Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
National PPE Distribution PMO Team — NHS England in Palantir...
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National PPE Distribution PMO Team
why: Supply Management Capability
what: National PPE Distribution PMO Team
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccination : Inpatient LD & Autism — NHS England in Palantir...
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COVID Vaccination : Inpatient LD & Autism
why: Immunisation and Vaccination Management Capability
what: COVID Vaccination : Inpatient LD & Autism
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Training Resources (Public) — NHS England in Palantir...
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Training Resources (Public)
why: System Admin
what: Training Resources (Public)
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Greener NHS Analytics — NHS England in Palantir...
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Greener NHS Analytics
why: Workforce Analytics Capability
what: Greener NHS Analytics
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Regional Elective Recovery Tool — NHS England in Palantir...
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Regional Elective Recovery Tool
why: Recovery of Critical Services
what: Regional Elective Recovery Tool
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
COVID Vaccine: Regional Leadership - South East — NHS England in Palantir...
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COVID Vaccine: Regional Leadership - South East
why: Immunisation and Vaccination Management Capability
what: COVID Vaccine: Regional Leadership - South East
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Data Sharing Agreement between NHS England and The Regional Health and Social Care Board and Public Health Agency Northern Ireland to enable the sharing of COVID Vaccination data — Regional Health and Social Care Board/Public Health Agency Northern Ireland...
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Data Sharing Agreement between NHS England and The Regional Health and Social Care Board and Public Health Agency Northern Ireland to enable the sharing of COVID Vaccination data
why: GDPR Article 6(1)(e) GDPR Article 9(2)(h) GDPR Article 9(2)(j) GDPR Article 9(2)(h) GDPR Article 9(2)(i)
what: Data Sharing Agreement between NHS England and The Regional Health and Social Care Board and Public Health Agency Northern Ireland to enable the sharing of COVID Vaccination data
who: Regional Health and Social Care Board/Public Health Agency Northern Ireland
where: disseminated
when: unstated
dataset: Confidential Patient Information including recorded data, NHS number, local identification and care setting. This data sharing initiative is necessary for the delivery of the parties functions in response to the COVID pandemic. The Data Sharing Agreement is in place for citizens in Northern Ireland who have been vaccinated in England and for citizens in England who have been vaccinated in Northern Ireland to ensure that the vaccination records are accurate.
optouts: unstated
Source -
Ingest Monitoring : Addenbrookes IMS — NHS England in Palantir...
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Ingest Monitoring : Addenbrookes IMS
why: System Admin
what: Ingest Monitoring : Addenbrookes IMS
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
SPI-M COVID Medium Term Projections — NHS England in Palantir...
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SPI-M COVID Medium Term Projections
why: Strategic Decision-Makers Dashboard
what: SPI-M COVID Medium Term Projections
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Early Warning Detection: Regional - Northwest Region — NHS England in Palantir...
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Early Warning Detection: Regional - Northwest Region
why: Early Warning System
what: Early Warning Detection: Regional - Northwest Region
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
CCS Export Quality Assurance — NHS England in Palantir...
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CCS Export Quality Assurance
why: System Admin
what: CCS Export Quality Assurance
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
Social Care: Test Data Publication - Data Export — NHS England in Palantir...
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Social Care: Test Data Publication - Data Export
why: System Admin
what: Social Care: Test Data Publication - Data Export
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source -
[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - North and East Yorkshire — NHS England in Palantir...
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[Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - North and East Yorkshire
why: System Admin
what: [Deprecated, please use Plan vs Actual Purpose] Plan vs. Actual - North and East Yorkshire
who: NHS England in Palantir
where: Palantir
when: unstated
dataset: unstated
optouts: unstated
Source
2025 - 12
-
ID-502: Evaluation of Harrow CRMs Clinics — Sphere Primary Care Network...
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ID-502: Evaluation of Harrow CRMs Clinics
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Sphere Primary Care Network
Description: Harrow.
Source -
ID-488-1: Evaluation of new approaches and investments in services to support diabetes care in North West London — Imperial College London...
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ID-488-1: Evaluation of new approaches and investments in services to support diabetes care in North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: diabetes care.
Source -
ID-249-5: Extension: The impact of COVID-19 on antibiotic prescribing in North West London — Imperial College London...
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ID-249-5: Extension: The impact of COVID-19 on antibiotic prescribing in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Antibiotics.
Source -
ID-363-2: Optimising patient journeys through the healthcare system — Imperial College Healthcare NHS Trust...
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ID-363-2: Optimising patient journeys through the healthcare system
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Patient journeys.
Source -
ID-496: Statin Use and Prediabetes Risk: Prediction Model Development and Causal Inference Using Data from the Whole Systems Integrated Care Database, Northwest London — Imperial College London...
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ID-496: Statin Use and Prediabetes Risk: Prediction Model Development and Causal Inference Using Data from the Whole Systems Integrated Care Database, Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Statin use.
Source -
ID-201-2: Investigating management of lung nodules, and the impact of pre-diagnostic surveillance on health and economic outcomes. — Imperial College Healthcare NHS Trust...
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ID-201-2: Investigating management of lung nodules, and the impact of pre-diagnostic surveillance on health and economic outcomes.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: lung nodules.
Source -
ID-500: Treatment patterns and outcomes in patients with irritable bowel disease — Lane Clark & Peacock LLP...
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ID-500: Treatment patterns and outcomes in patients with irritable bowel disease
Legal basis:research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: irritable bowel disease. Commercial
Source -
ID-433-2: Long term surveillance of patients on the Lipid Management Pathway — Imperial College Healthcare NHS Trust...
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ID-433-2: Long term surveillance of patients on the Lipid Management Pathway
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Lipid management. Commercial
Source -
ID-385-3: Carepath Data- Identifying risks and opportunities for better outcomes in Cardio-Metabolic care pathways — Imperial College Health Partners...
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ID-385-3: Carepath Data- Identifying risks and opportunities for better outcomes in Cardio-Metabolic care pathways
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Cardio-metabolic care. Commercial
Source -
ID-471-1: Surgery and advanced therapy patterns in inflammatory bowel disease, a retrospective population-based study in NWL — London North West University Healthcare NHS Trust...
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ID-471-1: Surgery and advanced therapy patterns in inflammatory bowel disease, a retrospective population-based study in NWL
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: London North West University Healthcare NHS Trust
Description: Inflammatory bowel disease. Commercial
Source -
ID-499: Integrated Community Access Point (ICAP) impact review — Central London Community Healthcare NHS Trust...
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ID-499: Integrated Community Access Point (ICAP) impact review
Legal basis:service evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-25
Opt Outs: no information provided./p>
Organisations: Central London Community Healthcare NHS Trust
Description: ICAP.
Source
2025 - 11
-
ID-374-4: PREPARE: Evaluation of the Electronic Palliative Care Coordination Systems to support advance care planning for people living with life-limiting conditions — Royal Marsden NHS Foundation Trust...
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ID-374-4: PREPARE: Evaluation of the Electronic Palliative Care Coordination Systems to support advance care planning for people living with life-limiting conditions
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Royal Marsden NHS Foundation Trust
Description: Palliative care coordination systems.
Source -
ID-436-2: A study to assess the affects of a randomised community health-worker led intervention on uptake of preventative care services in London, UK — Imperial College Healthcare NHS Trust...
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ID-436-2: A study to assess the affects of a randomised community health-worker led intervention on uptake of preventative care services in London, UK
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Preventative care services.
Source -
ID-300-6: Extension: Cluster analysis of patients with pre-metabolic and metabolic syndrome to determine their association with pathological outcomes, to aid the generation of pre-emptive therapeutic targeting utilising artificial intelligence — Imperial College Healthcare NHS Trust/Imperial College London...
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ID-300-6: Extension: Cluster analysis of patients with pre-metabolic and metabolic syndrome to determine their association with pathological outcomes, to aid the generation of pre-emptive therapeutic targeting utilising artificial intelligence
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/Imperial College London
Description: Metabolic Syndrome. Commercial
Source -
ID-477-1: Prescribing trends for young people with attention deficit hyperactivity disorder (ADHD) moving into adulthood. — Imperial College Healthcare NHS Trust...
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ID-477-1: Prescribing trends for young people with attention deficit hyperactivity disorder (ADHD) moving into adulthood.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: ADHD.
Source -
ID-495: Improving Resilience against cyber-attacks in Healthcare (iReach) — Imperial College London...
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ID-495: Improving Resilience against cyber-attacks in Healthcare (iReach)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Cyber attacks.
Source -
ID-459-1: Comparative Data Health Data / Sexual health JSNA — Westminster City Council...
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ID-459-1: Comparative Data Health Data / Sexual health JSNA
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Sexual health JSNA.
Source -
Re-ID-003: SCOPE-HF (study of cardiac outcomes in populations at risk and with established heart failure) — Guy’s and St Thomas’ NHS Foundation Trust...
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Re-ID-003: SCOPE-HF (study of cardiac outcomes in populations at risk and with established heart failure)
Legal basis:re-identification
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Guy’s and St Thomas’ NHS Foundation Trust
Description: Heart failure.
Source -
ID-259-6: Extension: JSNA Program — Westminster City Council...
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ID-259-6: Extension: JSNA Program
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: JSNA.
Source -
ID-497: London SDE’s NHS chronic weight management service provision & health systems capacity: a feasibility study — Imperial College Healthcare NHS Trust...
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ID-497: London SDE’s NHS chronic weight management service provision & health systems capacity: a feasibility study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Chronic weight management. Commercial
Source -
ID-454-1: Impact of Structured Medication Review for Adults with Polypharmacy in Primary Care — Imperial College NHS Healthcare Trust...
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ID-454-1: Impact of Structured Medication Review for Adults with Polypharmacy in Primary Care
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Primary Care.
Source - and 4 more projects — click to show
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ID-458-1: Re-Defining Care for Patients with Advanced Heart Failure in North West London — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-458-1: Re-Defining Care for Patients with Advanced Heart Failure in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart failure. Commercial
Source -
ID-216-7: Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London. — Imperial College London...
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ID-216-7: Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity in depression.
Source -
ID-379-4: Extension: Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS) — University of Southampton...
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ID-379-4: Extension: Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: University of Southampton
Description: Health and social care workforce organisation. Commercial
Source -
ID-271-6: Polypharmacy — Imperial College London...
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ID-271-6: Polypharmacy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Polypharmacy.
Source
2025 - 10
-
— unknown...
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Where: unstated
When: 2025-10-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This project aims to build an evidence base on early involvement with childrenâs social care in Northern Ireland, focusing on antenatal and postnatal contact, repeat removals, and repeat referrals.
Specifically, the project will explore the following questions:
Antenatal / early years contact
What proportion of mothers experience antenatal and/or postnatal ( up to 2 years after birth) contact with childrenâs social care and what are the factors associated with this? What proportion of these contacts involve repeated removals of multiple children from the same mother? What are the factors associated with this, and what are the care outcomes?Repeat referrals / statutory contact
What is the extent of repeat interactions with childrenâs social care and what are the characteristics of cases that were initially assessed as not in need, or received only non-statutory support, associated with later child protection or looked-after involvement?Care-experienced mothers
What are the intergenerational patterns of childrenâs social care involvement among care-experienced mothers, and which characteristics distinguish those whose children become looked after from those with no subsequent social care contact or non-statutory involvement?This project is using linked administrative data to explore antenatal and early years contact, repeat removals, and repeat referrals in Northern Ireland's child welfare system.
Source -
ID-183-8: Estimating inequalities in unmet clinical need in patients with obesity — Lane Clark & Peacock LLP...
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ID-183-8: Estimating inequalities in unmet clinical need in patients with obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Obesity. Commercial
Source -
ID-450-1: High Intensity Users evaluation — Imperial College NHS Healthcare Trust...
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ID-450-1: High Intensity Users evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: HIU.
Source -
ID-492: Prescribed Opioids, Polypharmacy and Falls: a Population Retrospective Cohort Study — Imperial College NHS Healthcare Trust...
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ID-492: Prescribed Opioids, Polypharmacy and Falls: a Population Retrospective Cohort Study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Polypharmacy.
Source -
ID-494: London Ambulance Service demand data – Falls prevention — Westminster City Council...
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ID-494: London Ambulance Service demand data – Falls prevention
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: LAS.
Source -
ID-252-5: Extension: Grenfell Bereaved and Survivors Population Health Monitoring — Westminster City Council...
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ID-252-5: Extension: Grenfell Bereaved and Survivors Population Health Monitoring
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Grenfell.
Source -
ID-177-7: Extension: Grenfell Population Health Monitoring — Westminster City Council...
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ID-177-7: Extension: Grenfell Population Health Monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: North Kensington.
Source -
ID-468-1: AI-DIP Artificial Intelligence for Cancer Diagnosis in General Practice — Imperial College London...
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ID-468-1: AI-DIP Artificial Intelligence for Cancer Diagnosis in General Practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Cancer Diagnosis.
Source -
ID-452-3: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy — Imperial College NHS Healthcare Trust...
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ID-452-3: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Family size.
Source -
ID-486: Clinical impact and healthcare utilisation of a digital long term conditions self-management platforms (Know Diabetes / Preventing Diabetes / MyHealth London): a mixed-methids evaluation — NHS Greater Glasgow and Clyde/ MyWay Digital Health...
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ID-486: Clinical impact and healthcare utilisation of a digital long term conditions self-management platforms (Know Diabetes / Preventing Diabetes / MyHealth London): a mixed-methids evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: NHS Greater Glasgow and Clyde/ MyWay Digital Health
Description: Healthcare Utilisation.
Source - and 7 more projects — click to show
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ID-444-1: Extension: How are the health and social care costs of neurodegenerative diseases including dementia, multiple sclerosis, Parkinson’s disease, Huntington’s disease and motor neurone disease) impacted by inequality and ethnicity? — University College London...
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ID-444-1: Extension: How are the health and social care costs of neurodegenerative diseases including dementia, multiple sclerosis, Parkinson’s disease, Huntington’s disease and motor neurone disease) impacted by inequality and ethnicity?
Legal basis:research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: University College London
Description: Neurodegenerative diseases.
Source -
ID-194-3: Extension: Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in North West London — West London Health NHS Trust...
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ID-194-3: Extension: Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: West London Health NHS Trust
Description: Personality Disorders.
Source -
ID-490: Smoking rates by GP practice — Westminster City Council...
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ID-490: Smoking rates by GP practice
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Smoking Rates.
Source -
ID-220-7: Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling — Imperial College Healthcare NHS Trust/ Imperial College London...
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ID-220-7: Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ Imperial College London
Description: Neurological conditions.
Source -
ID-135-9: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease — Lane Clark & Peacock LLP...
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ID-135-9: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Cardiovascular Disease.
Source -
ID-491: Evaluating the Care Information Exchange to Improve Patient Experience and Care Pathways in North West London — Patients Know Best...
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ID-491: Evaluating the Care Information Exchange to Improve Patient Experience and Care Pathways in North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Patients Know Best
Description: Patient Experience.
Source -
ID-472-1: Diabetic Retinopathy Risk Factors: How can we use patient data to identify people at risk of developing retinopathy — Brent Council...
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ID-472-1: Diabetic Retinopathy Risk Factors: How can we use patient data to identify people at risk of developing retinopathy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-25
Opt Outs: no information provided./p>
Organisations: Brent Council
Description: Retinopathy.
Source
2025 - 09
-
ID-422-1: Extension: Polypharmacy – Renal health inequalities — Imperial College London...
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ID-422-1: Extension: Polypharmacy – Renal health inequalities
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Renal Health.
Source -
ID-489: Homeless Health business case data — NWL ICB...
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ID-489: Homeless Health business case data
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: NWL ICB
Description: Homelessness.
Source -
ID-294-5: Extension: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment (additional user) — London Borough of Hounslow...
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ID-294-5: Extension: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment (additional user)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: London Borough of Hounslow.
Source -
ID-151-7: Extension: Care coordination for Adolescents in Crisis — Imperial College London...
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ID-151-7: Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Acute Mental H
ealth for CYP in NWL.
Source -
ID-487: Predicting incident psychosis among CAMHS-exposed youth using WSIC primary care EHR — Imperial college London...
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ID-487: Predicting incident psychosis among CAMHS-exposed youth using WSIC primary care EHR
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial college London
Description: CAMHS.
Source -
ID-249-4: Extension: The impact of COVID-19 on antibiotic prescribing in North West London — Imperial College London...
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ID-249-4: Extension: The impact of COVID-19 on antibiotic prescribing in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Antibiotics.
Source -
ID-483: using a whole systems data approach to monitor the changing health care burden of childhood bronchiolitis following introduction of RSV prophylaxis in Northwest London: a large linked clinical data study — Imperial College Healthcare NHS Trust...
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ID-483: using a whole systems data approach to monitor the changing health care burden of childhood bronchiolitis following introduction of RSV prophylaxis in Northwest London: a large linked clinical data study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Bronchiolitis.
Source -
ID-488: Evaluation of new approaches and investments in services to support diabetes care in North West London — Imperial College London...
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ID-488: Evaluation of new approaches and investments in services to support diabetes care in North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Diabetes Care.
Source -
ID-484: Determination of the incidence of dementia after pacemaker implantation in a real-world population — Imperial College Healthcare NHS Trust...
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ID-484: Determination of the incidence of dementia after pacemaker implantation in a real-world population
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Dementia.
Source -
ID-446-1: Extension Patient characteristics, health and social care resource utilisation and costs among community COVID-19 infections in North West London — Lane Clark & Peacock LLP...
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ID-446-1: Extension Patient characteristics, health and social care resource utilisation and costs among community COVID-19 infections in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: COVID-19. Commercial
Source -
ID-394-2: Extension: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse — Optum Health Solutions UK Ltd...
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ID-394-2: Extension: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-25
Opt Outs: no information provided./p>
Organisations: Optum Health Solutions UK Ltd
Description: WSIC.
Source
2025 - 08
-
ID-132-2: Extension: Pilot intervention for young self-harm patients in NWL — Imperial College London...
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ID-132-2: Extension: Pilot intervention for young self-harm patients in NWL
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Self-harm.
Source -
ID-476: Patient Safety in access and delivery of perinatal care amongst ethnic diverse communities in Northwest London – A Mixed Methods Study — Imperial College Healthcare NHS Trust...
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ID-476: Patient Safety in access and delivery of perinatal care amongst ethnic diverse communities in Northwest London – A Mixed Methods Study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Perinatal.
Source -
ID-481: WorkWell NWL – Service Evaluation (Oct 2024 – June 2025) — Imperial College Healthcare NHS Trust...
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ID-481: WorkWell NWL – Service Evaluation (Oct 2024 – June 2025)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: WorkWell.
Source -
ID-477: Prescribing trends for young people with attention deficit hyperactivity disorder (ADHD) moving into adulthood. — Imperial College Healthcare NHS Trust...
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ID-477: Prescribing trends for young people with attention deficit hyperactivity disorder (ADHD) moving into adulthood.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: ADHD.
Source -
ID-480: Evaluating preterm birth phenotypes and risk factors in North West London — Chelsea and Westminster NHS Foundation Trust...
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ID-480: Evaluating preterm birth phenotypes and risk factors in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster NHS Foundation Trust
Description: Preterm Birth.
Source -
ID-458-1: Extension: Re-Defining Care for Patients with Advanced Heart Failure in North West London — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-458-1: Extension: Re-Defining Care for Patients with Advanced Heart Failure in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart Failure. Commercial
Source -
ID-479: FIT-NWL: Using Primary Care Data to Track Sickness Absense in NWL — Imperial College Healthcare NHS Trust...
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ID-479: FIT-NWL: Using Primary Care Data to Track Sickness Absense in NWL
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Primary Care.
Source -
ID-294-4: Extension: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment — London Borough of Hounslow...
see more
ID-294-4: Extension: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: London Borough of Hounslow.
Source -
ID-478: Hounslow Care Together Teams – project evaluation and analysis — West London Trust...
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ID-478: Hounslow Care Together Teams – project evaluation and analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: West London Trust
Description: Care Together Teams.
Source -
ID-416-3: Evaluation of the accessibility of the Providing Assessment and Treatment for Children at Home (PATCH) service across North West London — Imperial College London...
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ID-416-3: Evaluation of the accessibility of the Providing Assessment and Treatment for Children at Home (PATCH) service across North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: PATCH.
Source -
ID-482: Asthma in Children – Asthma Friendly Schools — Westminster and Kensington and Chelsea Council...
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ID-482: Asthma in Children – Asthma Friendly Schools
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-25
Opt Outs: no information provided./p>
Organisations: Westminster and Kensington and Chelsea Council
Description: Asthma.
Source
2025 - 07
-
ID-468: AI-DIP Artificial Intelligence for Cancer Diagnosis in General Practice — Imperial College London...
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ID-468: AI-DIP Artificial Intelligence for Cancer Diagnosis in General Practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Cancer Diagnosis.
Source -
ID-453: Long-term consequences of perinatal depression — Brent Council...
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ID-453: Long-term consequences of perinatal depression
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: Brent Council
Description: Depression. Commercial
Source -
ID-342-4: Extension: Uncovering Patterns of Falls Risk Factors: A Cross-sectional Analysis of Integrated Electronic Health Records in North-West London — Imperial College London...
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ID-342-4: Extension: Uncovering Patterns of Falls Risk Factors: A Cross-sectional Analysis of Integrated Electronic Health Records in North-West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Falls. Commercial
Source -
ID-473: Adult Critical Care Analysis — NHS England...
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ID-473: Adult Critical Care Analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: NHS England
Description: Adult care.
Source -
ID-474: Cost-modelling the introduction of pharmacotherapy in adult weight-management service pathways in Northwest London — ICHNT...
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ID-474: Cost-modelling the introduction of pharmacotherapy in adult weight-management service pathways in Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: ICHNT
Description: Pharmacotherapy.
Source -
ID-220-6: Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling — Imperial College Healthcare NHS Trust/ Imperial College London...
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ID-220-6: Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ Imperial College London
Description: Neurological conditions.
Source -
ID-475: WorkWell – analysis of GP Fit note data — Westminster City Council...
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ID-475: WorkWell – analysis of GP Fit note data
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: July-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: GP Fit.
Source
2025 - 06
-
Retrospective, observational study of concomitant treatment with dapagliflozin and eplerenone for the treatment of heart failure: evaluation of clinical outcomes in real-world clinical practice — Christopher Morgan ...
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Retrospective, observational study of concomitant treatment with dapagliflozin and eplerenone for the treatment of heart failure: evaluation of clinical outcomes in real-world clinical practice
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-07
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Nikos Drosos - Collaborator - ELPEN Pharmaceutical Co. Inc
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Primary outcome: composite endpoint of heart failure hospitalization and cardiovascular mortality. Secondary outcomes: heart failure hospitalization; cardiovascular mortality, all-cause mortality; change in estimated glomerular filtration rate (eGFR); patients with a â¥30% reduction in eGFR; distribution of chronic kidney disease stages (G1-G5); change in systolic and diastolic blood pressure; patients with systolic blood pressure <90 mmHg; change in serum potassium, mean change in N-terminal pro B-type natriuretic peptide (NT-proBNP), incidence of adverse events (hypotension, hyperkalaemia); mean change in ejection fraction; change in New York Heart Association (NYHA) functional class; proportion of patients with NYHA functional class categorized as stable or improved
Description: Lay Summary
Heart failure is a serious and common condition in which the heart cannot pump blood effectively around the body. This can lead to symptoms such as breathlessness, tiredness, and fluid build-up in the legs or lungs. These symptoms often worsen over time and can result in frequent hospital admissions and a reduced life expectancy. In the United Kingdom, around 200,000 people are newly diagnosed with heart failure each year.
Although there is no cure for heart failure, several treatments can help people live longer and feel better. Two medicines known to benefit patients with heart failure are dapagliflozin and eplerenone. Dapagliflozin helps people with heart failure by reducing fluid overload and easing pressure on the heart. Eplerenone blocks a hormone called aldosterone, which can damage the heart and cause fluid retention. It has been shown to reduce hospital visits and improve survival.
We want to find out whether using these two medicines together works better than using just one. To do this, we will conduct a study using the Clinical Practice Research Datalink (CPRD) Aurum, a large UK database of anonymised patient health records. We will compare people with heart failure who are taking both dapagliflozin and eplerenone to those taking only one of these medicines. We will look at hospital admissions, survival, kidney function, blood pressure, and side effects. The results could help guide doctors in choosing the best combination of treatments to improve care and outcomes for people with heart failure.
Technical SummaryHeart failure (HF) is a chronic, progressive condition characterized by breathlessness, fluid retention, and a high risk of hospitalisation and mortality. Among current therapies, sodium-glucose cotransporter-2 (SGLT2) inhibitors and mineralocorticoid receptor antagonists (MRAs) have demonstrated significant benefits. Dapagliflozin, an SGLT2 inhibitor, alleviates cardiovascular stress by promoting diuresis and reducing preload. Eplerenone, an MRA, mitigates the deleterious effects of aldosterone. Evidence suggests that combined use of dapagliflozin and eplerenone may provide additive or synergistic effects, but validation in routine clinical practice is required. This retrospective observational cohort study will utilise data from the Clinical Practice Research Datalink (CPRD) Aurum, linked with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) mortality records. The study population will include adults with HF who were prescribed both dapagliflozin and eplerenone between 1 January 2019 and 31 March 2022. The index date will be the first date both drugs are prescribed concomitantly. Two comparator cohorts will be identified: (a) patients receiving dapagliflozin without any MRA, and (b) those receiving eplerenone without any SGLT2 inhibitor.
The primary outcome will be a composite of HF hospitalisation or cardiovascular death. Secondary outcomes include individual components of the primary outcome, all-cause mortality, adverse events (e.g., hyperkalaemia, hypotension), and changes in key clinical markers such as estimated glomerular filtration rate, serum potassium, N-terminal pro B-type natriuretic peptide, blood pressure, ejection fraction and New York Heart Association class.
A 12-month baseline period will assess demographics, comorbidities, and medication history. Propensity score matching (1:1) will be applied to balance covariates, and time-to-event outcomes will be analysed using Cox proportional hazards models and KaplanâMeier curves. Changes in clinical parameters will be evaluated at 6 and 12 months. Findings will contribute to real-world evidence guiding optimal HF management potentially improving patient outcomes.
Source -
Identifying and describing the characteristics of ulcerative colitis in an England population-based retrospective cohort study — Nicola Adderley ...
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Identifying and describing the characteristics of ulcerative colitis in an England population-based retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-02
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Andrea Utz - Corresponding Applicant - University of Birmingham
Ameeta Retzer - Collaborator - University of BirminghamOutcomes:
Use of corticosteroids such as Betamethasone, Hydrocortisone, Methylprednisolone, and Prednisolone; induction therapies; immunomodulators; Janus kinase (JAK) inhibitors; biologics; surgery (total procto-colectomy with end ileostomy; procto-colectomy with ileal pouch-anastomosis (IPAA) (J-pouch); colectomy with ileorectal anastomosis); Ulcerative colitis (UC)-related emergency hospital admission.
Description: Lay Summary
Ulcerative colitis (UC) is a chronic inflammatory condition of the colon which causes blood-stained diarrhoea and bleeding. It is one of the two main types of inflammatory bowel disease (IBD)-the other being Crohn's disease- and typically affects younger people of working age. IBD is epidemic and is predicted to affect 1% population by 2028. Despite the increasing burden of UC, it is not well understood who is being diagnosed and when, particularly across sociodemographic characteristics. Underserved populations are often underrepresented in research, including clinical trials, which limits the generalisability of findings.
To improve equity in research and inform inclusive UC trial design, we aim to describe the characteristics of patients with UC at the point of diagnosis-stratified by age, sex, ethnicity, and socioeconomic status. We will use routinely collected UK primary care data (CPRD) from the last 20 years (2004-2023).
The potential importance of the findings lies in providing a clear picture of who is affected by UC in the UK. By using real-world data, the study will describe key characteristics that can help highlight underrepresented groups or those experiencing health inequalities in research. These findings could contribute to enhancing equity in clinical trials, ensuring that future research includes a more representative sample of patients with UC, and improving treatment outcomes by addressing the needs of diverse patient groups.
Technical SummaryStudy objectives:
1. Describe the characteristics of patients at the time of ulcerative colitis (UC) diagnosis, overall and stratified by age, sex, ethnicity, and socioeconomic status, for each year between 2004- 2023.
2. Describe UC outcomes (medications, colectomy, hospitalisation) within 18-month diagnosis, overall and stratified by age, sex, ethnicity and socioeconomic status.
3. Explore changes in treatment patterns between 2004-2013 and 2014-2023.
4. Explore risk factors for colectomy within 18-month diagnosis, including age, sex, ethnicity and socioeconomic status.
5. Explore risk factors for at least one UC-related emergency hospital admission within 18-month diagnosis, including age, sex, ethnicity and socioeconomic status.Study population:
UC patients from England aged â¥12 years registered at a practice in CPRD Aurum for minimum 12 months.Primary exposure/outcomes:
Exposure/factors of interest: age, sex, ethnicity, deprivation (Index of Multiple Deprivation, IMD, quintile).
Covariates: we will describe the following at baseline, stratified by the above factors of interest:
-Comorbidities: mental health conditions (anxiety, depression, severe mental illness);
-Autoimmune diseases (rheumatoid arthritis, Sjogrenâs, eczema);
-Irritable bowel syndrome;
-Smoking status;
-Body mass index (BMI);
-Alcohol misuse;
-Medications: antibiotics, proton pump inhibitors, antidepressants, antipsychotics, GLP-1 agonists;
-Disease extent: proctitis, left sided, pan-colitis.Outcomes:
-Medications (Aminosalicylates, corticosteroids, induction therapies, immunomodulators, Janus kinase (JAK) inhibitors, biologics)
-Surgery: Procto-colectomy with end ileostomy; ileal pouch-anastomosis, and Colectomy with ileorectal anastomosis
-UC-related emergency hospital admissionData sources:
We will use the Clinical Practice Research Datalink Aurum database with linked Hospital Episode Statistics Admitted Patient Care data for descriptive statistics and hypothesis generating.Study design/methods:
Population-based cohort study. We will use descriptive statistics to summarise baseline characteristics and 18-month UC outcomes and apply logistic regression to identify factors linked to surgery and UC-related emergency hospital admission.Public health benefit:
The study will uncover underrepresented groups in health research, leading to improved treatment outcomes for all patient groups.
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Definition and validation of two control cohorts of patients with Achondroplasia (ACH) using GP primary care records and GP questionnaires. — Diane Hatziioanou ...
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Definition and validation of two control cohorts of patients with Achondroplasia (ACH) using GP primary care records and GP questionnaires.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-10
Organisations:
Diane Hatziioanou - Chief Investigator - CPRD
Daphne Martin - Corresponding Applicant - CPRD
Clare Iles - Collaborator - CPRD
Harley Kennedy - Collaborator - CPRD
Jeanne Pimenta - Collaborator - BioMarin Pharmaceutical Inc.
Rachael Williams - Collaborator - CPRD
Soraya Azmi - Collaborator - BioMarin Pharmaceutical Inc.
Susan Beatty - Collaborator - CPRD
Susan Hodgson - Collaborator - CPRD
Veronika Horvathova - Collaborator - BioMarin International LtdOutcomes:
Primary outcomes: ACH case definitions, Cohort of ACH patients
Secondary outcomes: positive predictive value of GP ACH records, alternative diagnosis frequencies, case control matching parameters.Description: Lay Summary
Achondroplasia (ACH) is a genetic cause of abnormal bone growth and results in small stature. While the most visible effects are in the arms, legs, and face, nearly all the bones in the body are affected. This condition can cause serious, progressive, and lifelong complications. A treatment approved in the EU, Voxzogo®, aims to promote bone growth in these patients and help achieve full adult height and may reduce the risk of other complications. Patients who have started treatment in Europe will be monitored as part of a study called Acorn, conducted by BioMarin. As Voxzogo® is not licensed in the UK, health records of ACH patients selected from CPRD can be compared to treated patients to determine drug safety.
The main aim of this study is to define a potential comparison group of ACH patients in CPRD data who have a valid diagnosis of ACH. Validation will be conducted via a questionnaire sent to GPs, who will medically confirm each diagnosis. This will help to understand when patients are incorrectly diagnosed, how diagnoses are made (e.g., a genetic test), raise awareness of conditions which are confused with ACH, and physical characteristics seen in ACH. This will give a more accurate picture of how many people in the UK have ACH, help clinicians to make diagnoses in the future, and provide the first step towards creating the most accurate comparison group to the patients in the Acorn study.
Technical SummaryACH is a rare, genetic condition resulting in skeletal dysplasia and other complications and is the most common cause of short stature. Voxzogo® (vosoritide) is a drug treatment which promotes bone-growth in patients with ACH and may prevent associated complications. A currently running European multicentre, non-interventional study (BioMarin, Acorn) aims to evaluate the long-term safety in ACH patients treated with vosoritide over 10 years.
The primary aim of this study is to use CPRD GOLD and Aurum to define and validate a cohort of ACH patients from the UK, where vosoritide is not licensed. These ACH case definitions will be validated using the CPRD PROVE (Providing Online Verification of Electronic Health Records) service providing insights on case definition to support the creation of cohorts of concurrent and historic UK untreated ACH patients for use as control groups compared to vosoritide-treated patients in future post-authorisation safety studies for Regulatory Agencies (subject to separate RDG approval). The CPRD PROVE GP questionnaire will be used to confirm diagnosis, elucidate typical clinical characteristics of ACH, occurrence of misclassification of ACH as other related conditions, and collate parameters to inform the design of future studies requiring an ACH control population. Descriptive statistics such as percentages and aggregated data counts will be prepared. This will benefit patients by allowing for future work to contextualise incidence of bone safety events of interest and ACH-related complications and surgeries Also to design and carry out future studies for biannual reporting to EMA as required in response to adverse events during post-authorisation safety studies.
Promoting bone growth may reduce the risk of additional complications of ACH. Therefore, outcomes of this work will enable improved understanding of the number of patients most likely to benefit from bone growth treatments in future, should a vosoritide drug treatment be authorised in the UK.
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Medication safety in pregnancy in women using modern antiseizure medication treatments: a cohort study — Anita McGrogan ...
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Medication safety in pregnancy in women using modern antiseizure medication treatments: a cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-03
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Marte-Helene Bjork - Collaborator - University of BergenOutcomes:
Primary outcomes
Live births; stillbirths; miscarriage; major congenital malformations; neurodevelopmental disorders;Secondary outcomes
Fetal growth restriction; sight and hearing disorders; maternal mortality; perinatal deathAdverse outcomes in the offspring (Objective 3) will include major congenital malformations; neurodevelopmental disorders; fetal growth restriction; sight and hearing disorders
Description: Lay Summary
The safety of newer medicines to treat illnesses in pregnancy including epilepsy, is unclear. Women need to know more about medicine safety when thinking about the benefits of treatment and the possible risks to their unborn child. Studying medicine safety in pregnancy is difficult. This is because you need large numbers of pregnant women, you need to detect rare events including birth defects, and you need to follow-up children for a number of years.
These challenges can be overcome by using data collected through routine healthcare visits. This study will include women who were given an anti-seizure medicine by their doctor in the year before or during their pregnancy. We will also look at a group of women who did not use this type of medicine during pregnancy. We will use information recorded about their pregnancy and we will find out whether their pregnancy ended with a loss or a livebirth. We will link the records of the mothers and their children to allow us to find out information about their development and medical conditions they have. These will then be compared between those whose mothers used different medicines during pregnancy and those who did not. This work will help improve the care of women using these medicines. It will help them decide what medicines to take when they are thinking about becoming pregnant. It will also help to make their pregnancy as safe as possible.
Technical SummaryAntiseizure Medicines (ASMs) are widely used to manage epilepsy, bipolar disorders, headache, pain and other neurological and psychiatric disorders. We know that certain ASMs pose significant risks for the child during pregnancy, including risks of congenital anomalies and neurodevelopmental disorders. However, only a few ASMs have been thoroughly evaluated for safety in pregnancy, limiting treatment options for women. This work aims to get a better understanding of antiseizure medications in pregnancy to better inform patients and healthcare professionals in planning pregnancies.
This study will use anonymised data from CPRD Aurum. The study period will run from 01-Jan-2000 to 31-Mar-2025. All women with â¥1 pregnancy during the study period will be eligible for inclusion. All prescriptions for an antiseizure medication in the 6 months before or during pregnancy will be identified. Comparisons will be made between pregnancies with different antiseizure medications prescribed during pregnancy and with pregnancies where there is no antiseizure medication prescribed. Comparisons will also be made between different indications for prescribing. Outcomes to be investigated include pregnancy loss, stillbirth, early neonatal death, maternal death and in the offspring, major congenital malformations, neurodevelopmental outcomes as well as fetal growth restriction and sight and hearing disorder if feasible.
Absolute risks of each outcome will be reported with 95% confidence intervals; logistic regression will be used to evaluate major congenital malformations and Cox proportional hazards will be used to evaluate pregnancy loss, stillbirth, neurodevelopmental disorder outcomes, fetal growth restriction and sight and hearing disorders. Adjustments for confounders will be made and sensitivity analyses will test potential misclassification of exposure and outcomes.
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Selective serotonin reuptake inhibitors (SSRIs) and the incidence of urinary tract infections (UTIs): a cohort study of older adults with depression — Helen McDonald ...
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Selective serotonin reuptake inhibitors (SSRIs) and the incidence of urinary tract infections (UTIs): a cohort study of older adults with depression
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-05
Organisations:
Helen McDonald - Chief Investigator - University of Bath
Anabella Kazubska - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Kathryn Mansfield - Collaborator - University of LincolnOutcomes:
Primary outcome: urinary tract infections.
Secondary outcomes: upper (severe) urinary tract infection
Description: Lay Summary
Selective Serotonin Reuptake Inhibitors (SSRIs) are a group of medicines, used for treating depression. Fluoxetine is a medicine which belongs to this group.
As we age, infections of the urinary tract (UTIs) become more and more common. In 2019, researchers found that fluoxetine can battle the bacteria which cause this infection. The study was done in the lab using model bladders. We donât know if fluoxetine helps reduce infections in people.
This study will use anonymous data from general practice in England to find out whether prescriptions for SSRIs decrease the chance of getting infections. We will study people with depression. We will see whether people who take an SSRI have fewer infections, compared to people who do not.
The results of the study may help some people choose what SSRI would be best for them, if they are somebody who experiences a lot of UTIs. This may help reduce infections for people with depression. This is important for peopleâs health. It may also help reduce use of antibiotics, which is important for public health.
Technical SummaryUrinary tract infections (UTIs) are very common among the aging population (incidence 10 per 100 person-years).
In-vitro evidence exists that certain SSRIs inhibit key functions of Proteus mirabilis â a bacterial cause of UTIs. If specific SSRIs are associated with a decreased UTI incidence, this could inform antidepressant treatment selection.This will be a hypothesis testing cohort study to investigate the effect of SSRIs on the rate of primary-care diagnosed UTIs among older people with depression. The study population will be adults aged 65 years and older with depression, followed from the latest of 1st January 2005, their 65th birthday, depression diagnosis, or one year after registration start date. Follow-up will end at the earliest of death, end of registration with GP practice, last data collection date, 105th birthday, or 31st December 2019. There will be two main comparison groups: SSRI users and non-users of antidepressant medications. The rate of UTIs in each exposure group will be described using Poisson regression adjusted for clustering using robust standard errors. Multivariable Poisson regression will be used to describe the association between SSRIs and UTI incidence. A priori confounders which will be adjusted for are: age, sex, ethnicity, region, deprivation, immunosuppression, diabetes mellitus, end stage renal disease, Parkinsonâs disease, dementia, and frailty. CPRD Aurum primary care data will be used to define the study population, SSRI exposure, UTI episodes and confounders. Patient level index of multiple deprivation (IMD) data will be used for adjustment for IMD as a potential confounder. Likelihood ratio tests will be used to test the hypothesis whether SSRIs decrease the incidence of UTIs.
The study will support patient decision-making informed by whether SSRIs reduce UTI incidence, with potential public health benefit of reducing UTI incidence and antibiotic use, increasingly important for antimicrobial resistance.
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Menopause, Diabetes and the potential mitigating role of Hormone Replacement Therapy — Ruth Brauer ...
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Menopause, Diabetes and the potential mitigating role of Hormone Replacement Therapy
Datasets:GP data, Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-10
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Ruth Brauer - Corresponding Applicant - University College London ( UCL )
Chengsheng Ju - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )
Rohini Mathur - Collaborator - Queen Mary University of LondonOutcomes:
- Annual, 5-year and 10-year progression (incidence) rates (IR) for the development Type 2 Diabetes Mellitus (T2DM) from pre-diabetes, stratified by ethnicity, Townsend (deprivation) score, age (5 year age-bands) and ethnicity-specific BMI exposure categories separately;
- Annual (incident) Hormone Replacement Therapy prescribing rates (2004-2025);
- Hazard ratio for the association between the use of HRT and T2DM.Description: Lay Summary
The gradual lowering of the female hormone oestrogen during the menopausal transition, or peri-menopause, can affect sleep, mood, and physical wellbeing. Changes in oestrogen levels can also affect blood sugar, or glycaemic control. This is particularly relevant for (peri)menopausal women at risk of diabetes, such as women diagnosed with pre-diabetes. Pre-diabetes is a condition characterized by raised blood glucose levels, but below diabetes thresholds. Pre-diabetes is an important risk factor for developing Type 2 diabetes mellitus (T2DM). There is some evidence from small clinical trials that Hormone Replacement Therapy [HRT] may help to prevent uncontrolled blood glucose levels. We propose to measure the âreal-wordâ effect of using HRT on blood sugar control by conducting a population-based study using CPRD data.
Technical Summary
In a cohort of women aged 40-65 years living with pre-diabetes (sometimes called non-diabetic hyperglycaemia), our aim is to measure the risk of T2DM in women prescribed HRT, compared to women not prescribed HRT. Results will be stratified by age, ethnicity, socio-economic status (SES) and weight (measured as Body Mass Index [BMI]). Based on the English National Diabetes Audit 2024, we estimate that 850,000 women with pre-diabetes could benefit from strong evidence on the potential role of HRT in blood sugar control. We expect that our findings can be used to reduce the burden of pre-diabetes and progression to T2DM in women in (peri)menopause. Moreover, the expected outcomes of our research will add to existing evidence to inform HRT prescribing for women at risk of, or living with diabetes.The menopausal transition, or perimenopause, brings about natural changes in a woman's body, including shifts in oestrogen levels. Changes in oestrogen levels can affect glycaemic control. This is particularly relevant for (peri)menopausal women at risk of diabetes. Evidence from small clinical trials suggests that Hormone Replacement Therapy (HRT) may offer benefits beyond its traditional uses, potentially aiding in the prevention of uncontrolled blood glucose levels. HRT acts by replacing oestrogen lost during menopause and could thereby confer a positive effect on glucose control, potentially reducing the risk of diabetes.
We propose a series of population-based studies utilizing UK primary care data to investigate the real-world effects of HRT on glyceamic control. Our main objective is to measure the risk of Type 2 Diabetes Mellitus (T2DM) in women prescribed HRT compared to those not prescribed HRT in a cohort of women aged 40-65 years living with pre-diabetes between 1 January 2004 and the latest available date in 2025 (study period). Results will be stratified based on age, ethnicity, socio-economic status, and BMI. Pre-diabetes will be defined by a CPRD-recorded diagnosis of pre-diabetes or non-diabetic hyperglycemia (NDH). The exposed group will be women in receipt of newly recorded prescriptions of HRT. The comparator group will comprise 1) women with recorded mood and vasomotor symptoms of menopause (indexdate), but without a prescription for HRT and 2) women prescribed Selective Serotonin or Norepinephrine Reuptake Inhibitors (SSRIs/SNRIs) or clonidine for menopause symptoms (indexdate). We will measure a hazard ratio for the association between the use of HRT and T2DM using a Cox regression model with 95% Confidence Intervals. Propensity scores will be used to balance baseline characteristics between groups.
Our research has potential to reduce the burden of pre-diabetes and progression to T2DM in perimenopausal women, thereby contributing valuable evidence to guide HRT prescribing practices.
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Mental and physical health conditions and healthcare utilisation in people with Attention Deficit Hyperactivity Disorder (ADHD): A cohort study — Amber John ...
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Mental and physical health conditions and healthcare utilisation in people with Attention Deficit Hyperactivity Disorder (ADHD): A cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-09
Organisations:
Amber John - Chief Investigator - University of Liverpool
Amber John - Corresponding Applicant - University of Liverpool
Joshua Stott - Collaborator - University College London ( UCL )
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
The first set of primary outcomes are the top 10 listed causes of disability by age. These include:
Depressive disorders; lower back pain; headache disorders; drug use disorders; Covid-19;
anxiety disorders; gynecological disorders; alcohol use disorders; self-harm; other
musculoskeletal disorders; ischemic heart disease; lung cancer; diabetes; COPD; falls;
osteoarthritis; colorectal cancer; dementia; stroke; Lower respiratory infections.
Secondary outcomes are: Charlson comorbidity index; age at and cause of death.
The final set of primary outcomes are healthcare utilisation metrics: Number of primary care
consultations, number of investigations undergone, number of inpatient hospitalisations, average
length of inpatient hospitalisations.Description: Lay Summary
Attention Deficit Hyperactivity Disorder (ADHD) affects around 2.6 million people in the United Kingdom. ADHD is a condition that affects how the brain works and can cause difficulties in various areas of life. People with ADHD may experience difficulties with attention, impulsivity, and managing emotions, which can affect their education, work, relationships, and mental and physical health. This research aims to improve our understanding of ADHD by exploring the health challenges and healthcare needs of people with the condition. In this project, we will:
Technical Summary
1. Compare the patient and clinical characteristics of people with ADHD to those without ADHD.
2. Look at physical and mental health problems in people with ADHD, and how this compares to people without ADHD. This will also include investigating the causes of death.
3. Investigate how people with ADHD use healthcare services compared to those without ADHD.
4. Test whether certain groups of people with ADHD, like those from minority ethnic backgrounds, face more barriers or challenges in healthcare.
By using data from medical records linked to hospital and death records, this research will provide important information about the health needs of people with ADHD. The findings will help policymakers and healthcare providers understand the specific healthcare needs of people with ADHD and how they might be better supported, which could improve the care and resources available to them.Background: Around 3-5% of people in the UK have ADHD. People with ADHD disproportionately
experience disadvantage/adversity during their lives, which can impact health outcomes.
Research is needed to understand the characteristics, health needs and access to healthcare
services of people diagnosed with ADHD in the UK.
Aims: The aims are to:
1. Characterise people with diagnosed ADHD in the UK across important dimensions that are
often associated with health inequalities and compare the proportions with these characteristics to
the non-diagnosed population.
2. Compare rates of physical/mental health diagnoses, rates of comorbidity, and mortality in
people with ADHD to those without.
3. Compare healthcare utilisation between people with ADHD and those without.
4. Test whether characteristics associated with health inequalities (such as those detailed above)
are associated with worse health and healthcare outcomes in people with ADHD compared to
people with ADHD without those characteristics and compared to people without ADHD.
Methods:
Data: CPRD linked to Hospital Episode Statistics data and ONS death records.
Study population: Patients with an ADHD diagnosis and a comparison group without ADHD.
Primary exposure(s)/outcome(s): Exposures: Presence of an ADHD record and key
characteristics associated with inequality (e.g. ethnicity/ deprivation/caregiver status/comorbid
autism/age) within people with ADHD. Outcomes: 1. Health outcomes (top 10 causes of disability
adjusted life-years in the UK by age), 2. Mortality/cause of death, 3. Multimorbidity (Charlson
comorbidity index), 4. healthcare utilisation (e.g. number of GP consultations/hospital
admissions).
Statistical analyses: Poisson regression to compare rates of health conditions and healthcare
utilisation in people with diagnosed ADHD to those without, and whether there are within-group
inequalities.
Public health benefit: This will provide a national picture of the characteristics, rates of health
problems, and access to healthcare services in people with ADHD, how this compares to people
without ADHD, and whether there are within-group inequalities in this.
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Using the Clinical Practice Research Datalink (CPRD) for data enabled clinical studies: a descriptive study — Mark Gibson ...
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Using the Clinical Practice Research Datalink (CPRD) for data enabled clinical studies: a descriptive study
Datasets:GP data, Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-10
Organisations:
Mark Gibson - Chief Investigator - CPRD
Mark Gibson - Corresponding Applicant - CPRD
Chisomo Mutafya - Collaborator - CPRD
Martin Holding - Collaborator - CPRDOutcomes:
We will describe counts and percentages of patients and practices by age, gender, ethnicity and ONS region/devolved nation (where relevant). We will also generate prevalence rates for three common conditions in the adult population. These conditions are asthma, cardiovascular disease (coronary heart disease, cerebrovascular disease, peripheral arterial disease, rheumatic heart disease, congenital heart disease, deep vein thrombosis and pulmonary embolism, heart failure, arrhythmias, cardiomyopathies, aortic diseases) and type 2 diabetes. These conditions are defined as any relevant medical code at any timepoint. We will use code lists previously created by CPRD (See Appendix).
Description: Lay Summary
Recently, the Clinical Practice Research Datalink (CPRD) begun offering several services based around using CPRD data to enable recruitment into clinical trials. However, little work has been done to describe the CPRD population who may be eligible for these studies and assess whether this population is representative of the United Kingdom as a whole.
In this study we will describe the socio-demographic and geographic breakdown of those in CPRD who may be eligible to participate in interventional research trials, as well as the geographic spread of general practitioners (GPs) which have agreed to participate in interventional research. We will then compare population estimates to the Office of National Statistics (ONS) estimates to assess the representativeness of this population. Finally, we will describe the socio-demographic and geographic breakdown of those in this population with three commonly researched conditions â asthma, cardiovascular disease and type 2 diabetes.
The use of electronic health records to enable clinical trials has huge potential to make clinical trials more efficient, effective and representative of the UK population, which in turn will benefit public health. Therefore, it is vital we understand how useful and representative of the population the data being used is. This research study investigates this.
Technical SummaryRecently, the Clinical Practice Research Datalink (CPRD) has begun offering several services based around using CPRD data to enable recruitment into clinical trials. However, little work has been done to describe the CPRD population who may be eligible for these studies and assess whether this population is representative of the United Kingdom as a whole.
This study will assess/describe the following (using bar charts and heatmaps):
a) The distribution of practices which have agreed to take part in interventional research across different regions of the UK (Office for National Statistics regions, as well as devolved nations), and the spread of index of multiple deprivation quintiles for these practices
b) The sociodemographic characteristics (age, gender, ethnicity â defined by broad Office for National Statistics using the CPRD ethnicity record link) of the CPRD potentially eligible population (alive/currently registered, and of any age, in Gold and Aurum)
c) The distribution of this population across different regions of the UK (Office for National Statistics regions, as well as devolved nations)
d) The representativeness of this population compared to Office for National Statistics estimates (2023 mid-year UK estimates for age and sex, and 2021 census England and Wales census estimates for ethnicity)
e) Prevalence rates, based on the number of diagnosed patients at any time point, for three common conditions (asthma, cardiovascular disease and type 2 diabetes), in adults potentially eligible for interventional research (currently alive, registered and above the age of 18).The use of electronic health records to enable clinical trials has huge potential to make clinical trials more efficient and effective, which in turn will benefit public health. Therefore, it is vital we understand how useful and representative of the population the data being used is. This research study investigates this.
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Feasibility of Evaluating GLP-1RA Use in Obesity Management: Insights from CPRD Aurum and GOLD — Emily Wilkes ...
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Feasibility of Evaluating GLP-1RA Use in Obesity Management: Insights from CPRD Aurum and GOLD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-03
Organisations:
Emily Wilkes - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Emily Wilkes - Corresponding Applicant - Eli Lilly and Company Ltd. (UK)
LUCY MITCHELL - Collaborator - Eli Lilly and Company Ltd. (UK)Outcomes:
BMI; Weight; Height; Waist circumference; Number of BMI measurements (during follow-up and annualised); Age at index; Gender; Ethnicity; Hypertension; Dyslipidemia; Obstructive sleep apnea; Osteoarthritis; Cardiovascular diseases; Depression/anxiety; Number of prescriptions (during follow-up and annualised); Time between prescriptions (in days); Length of follow-up time (months); Dosage at each prescription (in mg, via look up tables)
Description: Lay Summary
Overweight and obesity are conditions which are characterised by excessive fat accumulation that can vary over time and presents a risk to health. A government survey conducted between 2022 and 2023 showed that 64% of people aged 18 or over in England are people with overweight or obesity, while 24% of people aged 18 or over in England are people living with obesity. Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are effective treatment options for individuals with obesity that promote glycaemic control and weight reduction. In recent years new injectable GLP-1RA medications have been made available to patients living with obesity including tirzepatide and semaglutide.
Technical Summary
The effectiveness of these injectable medications has been investigated within clinical trials but there is limited information on how these medications are being used for the treatment of patients living with obesity in real-world clinical practice in the United Kingdom.
The aim of this feasibility study is to assess the number of patients living with overweight or obesity being treated with Tirzepatide and semaglutide and the availability of dosing and body composition information of patients during treatment. These feasibility findings will inform if there is sufficient sample size to conduct a future study. If we can, that future study could help doctors and the NHS better understand how these medicines are used in everyday careânot just in clinical trials. This could lead to better treatment decisions and support for people living with obesity.Background: Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are effective treatments for people living with obesity, supporting weight loss and glycaemic control. While their effectiveness has been demonstrated in clinical trials, there is limited evidence on how these medicines are used in real-world UK clinical practice.
Aim: To assess the number of patients with obesity treated with tirzepatide or semaglutide and the availability of dosing and body composition data during treatment.
Objectives: Among adults with obesity who receive at least one prescription of tirzepatide or semaglutide, we will:i) describe demographic and clinical characteristics; ii) assess the availability and distribution of repeat prescriptions and dosing data.
Methods: Conducting a descriptive feasibility study using longitudinal data from CPRD Aurum and GOLD. The index date is defined as the first ever prescription of tirzepatide or semaglutide (index) between March 2023 and the latest available data, in adults with overweight or obesity and no diabetes diagnosis.
Outcomes: BMI, weight, height, and waist circumference at index, 6, and 12 months post-index; frequency of BMI measurements; demographics (age, gender, ethnicity); comorbidities; number and timing of prescriptions; and dosage distributions.
Data analysis: Descriptive statistics (counts, means, medians, SD, percentiles) will be used. Analyses will be stratified by medication and CPRD dataset (combined and separately).
Public Health Benefit: This feasibility study will determine whether CPRD data can support a larger study on real-world use of GLP-1RAs. Findings may inform future research and clinical guidance, helping to optimise obesity treatment in UK primary care.
Source -
Comparing Transportability Methods for Projecting Treatment Effect Heterogeneity to Evolving Target Populations Over Time Using Real-World Data on Glucagon-Like Peptide-1 Receptor Agonist and Dipeptidyl Peptidase-4 Inhibitors Users. — Samy Suissa ...
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Comparing Transportability Methods for Projecting Treatment Effect Heterogeneity to Evolving Target Populations Over Time Using Real-World Data on Glucagon-Like Peptide-1 Receptor Agonist and Dipeptidyl Peptidase-4 Inhibitors Users.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-10
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Gwen Aubrac - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Michael Webster-Clark - Collaborator - McGill University
Nkasiobi Hossanna Nwobi - Collaborator - McGill University
Qi Zhang - Collaborator - Lady Davis Institute of the Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
The outcome for this study is the incidence rate of the first occurrence of all-cause mortality or Major Adverse Cardiovascular Events (MACE), which includes:
⢠Myocardial infarction (heart attack)
⢠Stroke
⢠Cardiovascular death
⢠Coronary revascularization procedures (e.g., angioplasty and coronary artery bypass surgery)Description: Lay Summary
When researchers study new medical treatments, they often test them on carefully selected participants. However, these participants donât always represent everyone who might use the treatment in the real world. For example, people with other health conditions or who take additional medications are often excluded, even though they may eventually need the treatment. Policymakers rely on these studies to decide whether the treatment should be made available to the public. Therefore, it is essential that study results reflect how the treatment will work for the general population.
Technical Summary
Methods exist to adjust trial results, so they better represent the effects of treatments in real-world populations. However, another challenge is that populations change over time. For instance, patients may age, develop new health conditions, or use different medications for other conditions, all of which can affect how well the treatment works. To ensure study results remain relevant, we need better methods to account for these changes.
Our study will compare different methods for making trial results applicable to broader, evolving populations. We will use real-world data from patients on diabetes medications. Because the types of patients using these medications and the available medications have changed over time, it provides an ideal case study for testing and validating these methods.
By comparing these methods, our research aims to improve how study results are applied to diverse and changing populations. This will help doctors, policymakers, and public health professionals make better decisions about treatments, ultimately leading to more effective and fair healthcare for everyone.Randomized controlled trials (RCTs) are essential for public health decision-making but often have limited external validity due to restrictive designs, short follow-up periods, and unrepresentative populations. Pharmacoepidemiological studies using real-world data (RWD) offer valuable opportunities to assess drug safety and effectiveness in diverse, real-world settings. However, challenges such as selection bias and the difficulty of generalizing or transporting treatment effects to dynamic populations persist, especially as demographics and treatment landscapes shift. Addressing these issues requires robust methodologies that account for temporal population dynamics and changing effect modifiers. This study aims to: 1) compare statistical methods for extrapolating treatment effect heterogeneity to future populations, and 2) evaluate the performance of these methods under varying levels of population dynamics. We will focus on patients initiated on Glucagon-Like Peptide-1 Agonist (GLP-1 RA) and Dipeptidyl Peptidase-4 Inhibitors (DPP-4 inhibitors), with outcomes including all-cause mortality and Major Adverse Cardiovascular Events (MACE). Using the Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics (HES) Admitted Patient Care, Office for National Statistics (ONS) mortality data, and the Patient-Level Index of Multiple Deprivation (IMD), we will identify and follow patients treated from 2006 to 2023. We will first divide our study population into three independent cohorts based on treatment initiation period. Then, we will describe and visualize trends in patient characteristics and effect modifiers within each cohort to understand demographic shifts. Treatment effects within each cohort will be estimated using inverse probability weighting based on propensity scores derived from multivariable logistic regression. Finally, we will evaluate transportability methods such as inverse odds weighting and outcome modelling, to extrapolate effects across time. The findings will provide methodological insights for extrapolating treatment effects, ensuring that research findings remain relevant for evolving patient demographics. This research has significant implications for public health decision-making, clinical practice, and regulatory policy.
Source - and 29 more projects — click to show
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Measuring the incidence and cumulative lifetime risk of common menstrual symptoms being reported in English primary care using the Clinical Practice Research Datalink Aurum — Hannah Knight ...
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Measuring the incidence and cumulative lifetime risk of common menstrual symptoms being reported in English primary care using the Clinical Practice Research Datalink Aurum
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-02
Organisations:
Hannah Knight - Chief Investigator - The Health Foundation
Elizabeth Crellin - Corresponding Applicant - The Health Foundation
Christina Pagel - Collaborator - University College London ( UCL )
Dasha Belokhvostova - Collaborator - The Health Foundation
Ipek Gurol Urganci - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jay Hughes - Collaborator - The Health FoundationOutcomes:
N/A - our primary measures of interest are incidence and cumulative lifetime risk of reporting heavy and/or painful periods to during GP consultations.
Description: Lay Summary
Common menstrual symptoms impair the quality of life of many women who are otherwise healthy.
These symptoms include heavy menstrual bleeding (HMB) and painful periods (dysmenorrhea) and are estimated to affect 25% and 20% of women of reproductive age, respectively. They are sometimes caused by an underlying condition such as endometriosis or fibroids.
Previous studies have highlighted concerns about how effectively menstrual disorders are managed and treated in primary care, but the number of patients seeking help from general practitioners (GPs) for heavy and/or painful periods is not well understood and neither are their healthcare needs.
In this project we will calculate the incidence and cumulative risk of women reporting these symptoms to the GP during their reproductive lifetime. We will then describe how this varies by age, ethnicity and deprivation status. Finally, we will look at whether there were changes in womenâs care seeking behaviour for these symptoms before and after the COVID-19 pandemic.
It is important to know how many women are affected by menstrual symptoms and to understand the way in which they are using the health service. This information will enable services to explore opportunities to improve access to existing treatments and to highlight any disparities that exist in the care that women are given.
Technical SummaryObjectives
This study aims to support GPs, gynaecologists and commissioners to understand the health service needs of patients with heavy and/or painful periods, and how these vary by clinical and socio-demographic factors.We will use SNOMED code lists for two common menstrual symptoms (menorrhagia and severe dysmenorrhea) that were developed during a feasibility project.
These code lists will be applied to a random sample of 1.1 million female patients who were of reproductive age (aged 12 to 54 years) in 2019. 2019 was selected as the base year to examine reporting of these symptoms before disruptions to primary care as a result of the COVID pandemic.
This dataset will be used to:
⢠Estimate the incidence and cumulative lifetime risk of common menstrual symptoms in CPRD in 2019, overall and by sub-condition
⢠Describe the characteristics of patients who attend their GP with a common menstrual symptom, by age; ethnic and deprivation profiles.The above analysis will then be repeated for two separate cohorts of women (using 2022 and 2023 as the years of interest) to examine the impact of COVID-19 pandemic and recovery on care-seeking behaviour.
It is hoped that this information will enable primary care services to identify opportunities to improve access to existing treatments for heavy and/or painful periods, and to highlight any disparities that exist in the care that women are given.
Source -
Safety of mRNA COVID-19 vaccines during pregnancy — Daniel Prieto...
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Safety of mRNA COVID-19 vaccines during pregnancy
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-06-09
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Nuria Mercade Besora - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Anna Saura-Lazaro - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Edward Burn - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
1) Adverse Events of Special Interest (AESI): Deep vein thrombosis; Pulmonary embolism; Myocardial infarction; Ischaemic stroke; Bellâs palsy; Encephalitis; Guillain Barré Syndrome; Transverse Myelitis; Haemorrhagic stroke; Myocarditis or pericarditis; Thrombosis with Thrombocytopenia; Immune Thrombocytopenia; Anaphylaxis; Narcolepsy; Disseminated Intravascular Coagulation
2) Maternal Adverse Events (MAE): Miscarriage; Stillbirth; Preterm labour; Eclampsia; HELLP syndrome; Antepartum Haemorrhage; Dysfunctional labour; Postpartum haemorrhage; Postpartum endometritis; Maternal death; Gestational diabetes; Ectopic pregnancy; Pre-eclampsiaDescription: Lay Summary
In this study we aim to improve the understanding of complications during pregnancy, and to find out if COVID-19 vaccination during pregnancy increases the risk of these complications.
Technical Summary
First, we will analyse healthcare data to find out how often complications like blood clots, strokes, or miscarriage, happen during pregnancy. Then, we will investigate if there are differences between pregnant women who experienced complications and those who did not.
Second, we will compare pregnant women receiving the 1st, 2nd, or booster (3rd or subsequent doses) COVID-19 vaccine doses with those eligible for the same dose, but who have not received it yet. We will compare how often complication happened between groups to see if vaccination increased risk of complications. The study will be restricted to COVID-19 vaccines recommended for used on pregnant women.
By conducting this study, we aim to provide evidence on the safety of COVID-19 vaccines during pregnancy, helping to guide healthcare decisions for pregnant women and their providers.Background
mRNA COVID-19 vaccines are recommended for use during pregnancy. While observational studies have suggested that these vaccines are safe during pregnancy, most were not powered to study rare adverse events or assess dose-specific risks. Further evaluation is needed to contextualize background rates of adverse events during pregnancy.Objectives
This study has 2-objectives: (1) to describe the incidence of selected adverse events during pregnancy, and (2) to evaluate the association between mRNA COVID-19 vaccination during pregnancy and the risk of adverse events.Methods
Objective 1: descriptive epidemiological study including all pregnancies from January 2018 to 9-months before the end of data availability. Incidence rates will be estimated for selected adverse outcomes among pregnant women, stratified by calendar month, year, age, and trimester. Baseline characteristics of individuals who experience an adverse outcome will be compared with those of matched (age and gestational age) outcome-free pregnant women.Obejctive 2: three cohort studies using a target trial emulation framework to assess the safety of first, second, and booster mRNA vaccine doses, respectively. Pregnant individuals aged 12 to 55 years, with at least one year of prior history, and eligible to receive the dose of interest during pregnancy will be included. Pregnant women receiving the vaccine dose of interest will be compared with those eligible for the same dose but who have not received it yet. Propensity score weighting will be applied to balance cohorts. Balance will be assessed using standardised mean differences and negative control outcomes. Outcome risk will be estimated using incidence rate ratios.
Adverse outcomes include 15 Adverse Events of Special Interest (e.g., myocardial infarction, anaphylaxis, Guillain-Barré syndrome...) and 13 Maternal Adverse Events (e.g., miscarriage, preterm labour, stillbirth...).
Intended Public Health Benefit
Study results can inform future COVID-19 vaccination campaigns and strengthen surveillance of vaccine and medication safety in this population.
Source -
ID-158-5: Extension: Impact of organisational models in general practice on patient safety and associated costs — Imperial College London...
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ID-158-5: Extension: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: NWL
.
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ID-394-1: Extension: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse — Optum Health Solutions UK Ltd...
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ID-394-1: Extension: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Optum Health Solutions UK Ltd
Description: missing.
Source -
ID-437-1: Extension: Analysis into ‘hard to diagnose’ cancers seen at rapid diagnostic centres in north west london — Chelsea and Westminster NHS Foundation Trust...
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ID-437-1: Extension: Analysis into ‘hard to diagnose’ cancers seen at rapid diagnostic centres in north west london
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster NHS Foundation Trust
Description: Cancer.
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ID-427-1: Detecting and treating CKD at the earliest stages — Imperial College Healthcare NHS Trust...
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ID-427-1: Detecting and treating CKD at the earliest stages
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: CKD.
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ID-158-5: Extension: Impact of organisational models in general practice on patient safety and associated costs — Imperial College London...
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ID-158-5: Extension: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: missing.
Source -
ID-394-1: Extension: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse — Optum Health Solutions UK Ltd...
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ID-394-1: Extension: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Optum Health Solutions UK Ltd
Description: missing.
Source -
ID-327-5: ICHP Feasibility Searches — Imperial College Health Partners...
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ID-327-5: ICHP Feasibility Searches
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: missing.
Source -
ID-425-1: Extension: Exploration of patient characteristics and inequities in healthcare presentations and testing for infectious gastroenteritis — Imperial College Healthcare NHS Trust...
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ID-425-1: Extension: Exploration of patient characteristics and inequities in healthcare presentations and testing for infectious gastroenteritis
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Infectious gastroenteritis.
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Re-ID-002: Proactive management for vulnerable patients including patients with LTCs — St John’s Wood Medical Practice...
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Re-ID-002: Proactive management for vulnerable patients including patients with LTCs
Legal basis:Re-Identification
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: St John’s Wood Medical Practice
Description: LTCs.
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ID-267-5: Extension: Evaluation of the online access route to general practice — Imperial Clinical Analytics Research & Evaluation (ICHNT) / NIHR Imperial Patient Safety Translational Research Centre...
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ID-267-5: Extension: Evaluation of the online access route to general practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial Clinical Analytics Research & Evaluation (ICHNT) / NIHR Imperial Patient Safety Translational Research Centre
Description: General Practice.
Source -
ID-412-2: Extension: Inequalities in Mental Healthcare Services: A Mixed-Method Approach Identifying Actionable Measures to Monitor Inequalities and Inform Improvement Efforts — Imperial College London...
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ID-412-2: Extension: Inequalities in Mental Healthcare Services: A Mixed-Method Approach Identifying Actionable Measures to Monitor Inequalities and Inform Improvement Efforts
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental health.
Source -
ID-436-1: A study to assess the affects of a randomised community health-worker led intervention on uptake of preventative care services in London, UK — Imperial College Healthcare NHS Trust...
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ID-436-1: A study to assess the affects of a randomised community health-worker led intervention on uptake of preventative care services in London, UK
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Preventative care services.
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ID-416-2: Extension: Evaluation of the accessibility of the Providing Assessment and Treatment for Children at Home (PATCH) service across North West London — Imperial College London...
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ID-416-2: Extension: Evaluation of the accessibility of the Providing Assessment and Treatment for Children at Home (PATCH) service across North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: PATCH.
Source -
ID-471: Surgery and advanced therapy patterns in inflammatory bowel disease, a retrospective population-based study in NWL — London North West University Healthcare NHS Trust...
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ID-471: Surgery and advanced therapy patterns in inflammatory bowel disease, a retrospective population-based study in NWL
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: London North West University Healthcare NHS Trust
Description: Inflammatory Bowel Disease. Commercial
Source -
ID-452-2: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy — Imperial College NHS Healthcare Trust...
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ID-452-2: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Family size.
Source -
ID-382-1: Extension New care pathway to support patients with Heart Failure with Preserved Ejection Fraction — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-382-1: Extension New care pathway to support patients with Heart Failure with Preserved Ejection Fraction
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart failure.
Source -
ID-467: Evaluating the Impact of Virtual Care on the Safety and Efficacy of Diabetic Pregnancy Management in North West London — Imperial College London...
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ID-467: Evaluating the Impact of Virtual Care on the Safety and Efficacy of Diabetic Pregnancy Management in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Diabetes.
Source -
ID-416-2: Extension: Evaluation of the accessibility of the Providing Assessment and Treatment for Children at Home (PATCH) service across North West London — Imperial College London...
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ID-416-2: Extension: Evaluation of the accessibility of the Providing Assessment and Treatment for Children at Home (PATCH) service across North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: PATCH.
Source -
ID-174-4: Extension: Children & Young People JSNA (CYP JSNA) — London Borough of Brent...
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ID-174-4: Extension: Children & Young People JSNA (CYP JSNA)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: London Borough of Brent
Description: JSNA.
Source -
ID 148-9. Extension Request: Characterizing and Preventing Multimorbidity in NW London — Imperial College London...
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ID 148-9. Extension Request: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multi-morbidities in NWL that stem from diabetes, pre-diabetes, hypertension, and depression.
Source -
ID 148-9. Extension Request: Characterizing and Preventing Multimorbidity in NW London — Imperial College London...
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ID 148-9. Extension Request: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multi-morbidities in NWL that stem from diabetes, pre-diabetes, hypertension, and depression.
Source -
ID-472: Diabetic Retinopathy Risk Factors: How can we use patient data to identify people at risk of developing retinopathy — Brent Council...
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ID-472: Diabetic Retinopathy Risk Factors: How can we use patient data to identify people at risk of developing retinopathy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Brent Council
Description: Retinopathy.
Source -
ID-379-3: Extension: Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS) — University of Southampton...
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ID-379-3: Extension: Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: University of Southampton
Description: Health and social care workforce organisation. Commercial
Source -
ID-382-1: Extension New care pathway to support patients with Heart Failure with Preserved Ejection Fraction — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-382-1: Extension New care pathway to support patients with Heart Failure with Preserved Ejection Fraction
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart failure.
Source -
ID-352-5: Extension: North West London Integrated Care Board (ICB) Research And Innovation Project. — Imperial College Health Partners...
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ID-352-5: Extension: North West London Integrated Care Board (ICB) Research And Innovation Project.
Legal basis:Research and Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Multimorbidity, acute care, and mental health.
Source -
ID-433-1: Long term surveillance of patients on the Lipid Management Pathway — Imperial College Healthcare NHS Trust...
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ID-433-1: Long term surveillance of patients on the Lipid Management Pathway
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Lipid management. Commercial
Source -
ID-229-6: Extension: Mapping the clinical journey of patients with Chronic Kidney Disease (CKD)in North West London (NWL) — Imperial College Healthcare NHS Trust/ Imperial College London...
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ID-229-6: Extension: Mapping the clinical journey of patients with Chronic Kidney Disease (CKD)in North West London (NWL)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: June-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ Imperial College London
Description: Chronic Kideny Disease. Commercial
Source
2025 - 05
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The effect of weight loss interventions on pregnancy and neonatal and early childhood outcomes: a UK cohort study — Chloe Bloom ...
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The effect of weight loss interventions on pregnancy and neonatal and early childhood outcomes: a UK cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation Domains; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Ethnicity Record; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-07
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Bohee Lee - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
Matthew Waite - Collaborator - Imperial College Healthcare NHS Trust
Tricia Tan - Collaborator - Imperial College LondonOutcomes:
The outcomes will include birthweight, gestational age at delivery, gestational hypertension, pre-eclampsia, gestational diabetes mellitus, hyperemesis gravidarum, intrahepatic cholestasis of pregnancy, pregnancy loss (miscarriage, stillbirth), anxiety and depression diagnosed during pregnancy, neonatal mortality, mode delivery, premature birth, congenital abnormalities, developmental delay, offspring diabetes and obesity.
Description: Lay Summary
Obesity during pregnancy can lead to complications such as high blood pressure, diabetes, and abnormal baby growth. It can also increase the risk of obesity and obesity-related diseases for the child later in life. Many women with obesity are choosing to lose weight to improve their health and fertility, either by undergoing weight loss surgery (WLS) or taking weight loss medications, as attempts to change eating behaviours to lose weight is often ineffective. However, we still have limited knowledge about how weight loss, either by surgery or medication, affects pregnancy and newborn health in the UK.
Studies from other countries suggest that weight loss, especially by WLS, may lead to both benefitsâsuch as lower risks of pregnancy-related high blood pressure, diabetes, and having overly large babiesâand potential risks, including a higher chance of birth defects, premature babies, low birth weight, and newborns needing extra medical care.
This project will compare pregnancy and offspring outcomes in obese women who have had a weight loss treatment, either surgery or medication, with women who have not had such weight loss treatment. The findings will help us better understand the risks and benefits of weight loss approaches for pregnancy and will improve care for both mothers and babies.
Technical SummaryIn this study we aim to compare pregnancy and offspring outcomes in obese women between three groups: women without medically documented intervention for their weight, women using weight-loss medication and women that underwent weight loss surgery.
To do this, we will draw a population of women aged 20-45 years with documented body mass index (BMI) of 30 or more between 2000 and 2024. The exposure will be a weight loss intervention, either surgery or medication. We will conduct a matched cohort for each exposure, matching both cohorts on age, year of delivery, BMI pre-intervention and time between intervention and pregnancy. We will follow them from the time of the intervention until delivery and then follow their offspring until maximum of 10 years of age. We will use mixed-effects multivariable linear regression to measure the association between each intervention and adverse pregnancy and offspring outcomes that are continuous (e.g. birthweight, the primary outcome) or logistic regression for binary outcomes (e.g. gestational diabetes, gestational hypertension). The random effect will be GP practice. The outcomes will be determined using CPRD, Hospital Episodes Statistics and Office of National Statistics death registration data. Model covariates will include age, BMI, socioeconomic status, ethnicity, smoking, comorbidities, parity. We will stratify by factors including age, types of weight loss surgery, type of weight loss medication and amount of weight loss achieved.
Given the rising prevalence of obesity in women of reproductive age, optimising maternal weight and metabolic health before conception has become a key public health priority. This study will provide patients and clinicians the information required to make informed decisions about weight loss interventions.
Source -
Evaluating and addressing the impact of COVID-19 restrictions on electronic health records in estimating causal effects: risks and benefits of oral anticoagulants — Yun "Angel" Wong ...
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Evaluating and addressing the impact of COVID-19 restrictions on electronic health records in estimating causal effects: risks and benefits of oral anticoagulants
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-28
Organisations:
Yun "Angel" Wong - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jonathan Bartlett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
ischaemic stroke, venous thromboembolism, myocardial infarction and major bleeding
Description: Lay Summary
Electronic health records (EHRs) are collected as part of routine healthcare in general practice and hospital settings, and are a valuable source for research. They are made anonymous so that individuals cannot be identified. During the COVID-19 pandemic, access to healthcare was disrupted and patients may have been reluctant to seek care for non-COVID health conditions. This led to disease diagnoses being either delayed or missed, which is called measurement error. These changes to when and how health data was recorded could mean that research studies using this data could have flawed results.
This study aims to assess and quantify potential measurement errors in data relating to the use of oral anticoagulants (blood-thinning medications) in people with atrial fibrillation (a common abnormal heart rhythm disease) during 2012-2023. Oral anticoagulants are used to prevent blood clots but could lead to side-effects such as internal bleeding. We will use primary care data from the UK Clinical Practice Research Datalink Aurum database linked with hospital and death registration records. We will describe trends of diagnoses for heart problems and bleeding over time in these databases. We will compare the risk of heart and bleeding outcomes between different types of oral anticoagulants and then compare results from before the pandemic to the results after. We will also explore whether novel statistical techniques can be used to successfully handle pandemic-related measurement errors. This study will improve the quality of future research by providing techniques to assess and correct measurement errors caused by the pandemic.
Technical SummaryCOVID-19 pandemic lockdowns have led to changes in recording in electronic health records, potentially leading to measurement and misclassification errors in research estimating causal effects. This study will assess and quantify potential measurement errors using a case study that investigates the risks and benefits of long-term routine therapy with oral anticoagulants. We will use data from the UK Clinical Practice Research Datalink Aurum linked with Hospital Episode Statistics and Office for National Statistics. By categorising three periods which are pre-, during and post-pandemic periods during 2012-2023, we will describe absolute rates of disease diagnoses for the identification of both study populations and outcomes; and comparing treatment effects using pre-pandemic data only with that combining pre-, during and post-pandemic data. Outcomes will include ischaemic stroke, venous thromboembolism, myocardial infarction and major bleeding. We will estimate hazard ratios for each outcome comparing the use of each direct oral anticoagulant with warfarin. Propensity score methods will be used to control for confounding. The findings will then be validated against previously generated evidence . We will quantify the measurement errors using a period-treatment interaction to evaluate treatment effects in stratified periods.
We will explore the use of three statistical techniques to handle pandemic-related measurement errors, including a Bayesian approach, the simulation-extrapolation method, and quantitative bias analysis. Where quantitative bias analysis has been developed primarily or only for binary outcomes, we will also estimate the odds ratio. This study will improve the quality of future causal research by providing statistical techniques to assess and correct measurement errors due to changes in diagnostic recording throughout the pandemic.
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Factors Associated with Uptake and Adherence to Lung Cancer Screening and Outcomes Following Screening — Jennifer Quint ...
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Factors Associated with Uptake and Adherence to Lung Cancer Screening and Outcomes Following Screening
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-02
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Wiriya Mahikul - Corresponding Applicant - Imperial College London
Benedict Hayhoe - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Geva Greenfield - Collaborator - Imperial College LondonOutcomes:
1. Uptake of lung cancer screening - the proportion of invited high-risk individuals those aged 55 to 74 who have ever smoked, such as current or former smokers who attend the initial assessment in the NHS Lung Health Check program.
2. Adherence to lung cancer screening - the proportion of participants who return for a second low-dose CT scan within 11-15 months after the baseline screening.
3. New diagnoses of COPD, hypertension, diabetes and hypercholesterolaemiaDescription: Lay Summary
Lung cancer is the second most common cancer worldwide and a leading cause of cancer death. Lung cancer screening (LCS) with low dose computed tomography (CT) can significantly reduce mortality by approximately 20%. In addition to its benefits for lung cancer detection, screening also presents an opportunity for the early detection of chronic obstructive pulmonary disease (COPD) and cardiovascular diseases (CVDs). Several countries, including the US and the UK, have started offering lung cancer screening to high-risk individuals who have ever smoked, such as current or former smokers aged 55 to 74. Despite its benefits, many eligible individuals do not take up the initial screening invitation, and do not continue to complete the programme.
Technical Summary
This study aims to define factors associated with the uptake and adherence to lung cancer screening and to determine if there are differences in new diagnoses of cardiovascular or respiratory diseases in those screened and not. We will explore demographic and clinical characteristics that may be associated with uptake of and adherence to lung cancer screening using primary care data. We will also examine how factors including age, smoking history, and other health conditions impact patientsâ decisions about screening.
By defining groups with the highest non-participation and non-adherence, screening programmes and healthcare providers can tailor strategies to increase awareness and encourage the uptake and adherence to lung cancer screening. This work will also help us to understand if there is potential for screening for other respiratory or cardiovascular diseases following lung cancer screening.Lung cancer is the leading cause of cancer incidence and mortality worldwide. Low-dose computed tomography (CT) screening has been shown to reduce lung cancer mortality. Beyond its role in lung cancer screening, this screening approach also provides an opportunity for the early detection of chronic obstructive pulmonary disease (COPD) and cardiovascular diseases (CVDs). In the UK, the NHS Lung Health Check program offers targeted lung cancer screening for individuals at high risk of developing lung cancer, specifically those aged 55 to 74 who have ever smoked. Despite its benefits, many eligible individuals do not take up the initial screening, and do not adhere to lung cancer screening. This study aims to define factors associated with the uptake and adherence to lung cancer screening and comorbidities in the cohort. We will use linked CPRD Aurum with HES APC as well as Index of Multiple Deprivation (IMD) data. The study period is from 1 March 2022 to 1 April 2025. We will assess demographic and clinical characteristics influencing screening engagement and comorbidities. Uptake will be defined as attendance at the initial assessment, while adherence refers to returning for a follow-up low-dose CT scan within 11â15 months. We will use multivariable logistic regression to assess the factor associated with uptake and adherence to lung cancer screening. We will also explore if new diagnoses of COPD or cardiovascular disease (hypertension, diabetes, hypercholesterolaemia) differ in those screened and not. The findings will inform targeted interventions to address barriers and non-adherence to lung cancer screening, improving early detection rates and enhancing the feasibility and potential for joint screening of lung cancer, COPD, and CVDs within the community. By defining populations with the lowest participation, this study aims to guide screening programme policy, support efforts to enhance screening effectiveness, and ultimately contribute to reducing lung cancer mortality.
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Understanding the incidence of idiopathic inflammatory myopathies in the UK — Theresa Smith ...
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Understanding the incidence of idiopathic inflammatory myopathies in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-02
Organisations:
Theresa Smith - Chief Investigator - University of Bath
Theresa Smith - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Jamie Campbell - Collaborator - University of Bath
Juan Jimenez - Collaborator - University of Bath
Sarah Tansley - Collaborator - University of BathOutcomes:
Primary outcome: Incidence rates of Myositis
Secondary outcomes: Incidence rates of different Myositis subtypes (dermatomyositis, polymyositis, IMNM, anti-synthetase syndrome, inclusion body myositis); prescribing of statins; prescribing of prednisolone; 5-year survival
Description: Lay Summary
âMyositis" refers to a group of rare diseases where the body's immune system attacks muscles, causing weakness and disability. People with myositis can also get rashes and inflammation in the joints, lungs, and heart. Different types of myositis affect patients differently and may have different causes. The number of people affected by myositis is not well known, and estimates have varied hugely. Research done in other countries suggests that more people are being diagnosed with myositis now than in the past. We don't know if this is because doctors are better at diagnosing myositis or because more people are affected. We know that for some patients, myositis can be triggered by medicines called statins. Infections have also been suggested as a trigger. For most people with myositis the cause is unknown.
The goal of this study is to find out how common myositis is in the UK and whether this has changed over time. We will also explore how often certain medicines are linked to the development of myositis, and if there are more diagnoses at certain times of the year. Understanding how trends change over time can help us learn about triggers for myositis and what kinds of people are most at risk of developing myositis. This will lead to a better understanding of how and why myositis occurs. In turn, this will inform new treatments and ways to prevent myositis occurring.
Technical SummaryIdiopathic inflammatory myopathies (IIM) are a group of rare autoimmune diseases, collectively called myositis, characterised by inflammation of skeletal muscle and other organs such as skin, joints, lungs, and heart. Previous studies report highly variable estimates of annual incidence of IIM as well as some evidence of seasonal patterns and increases in incidence over time. To the best of our knowledge, there are no previous studies using validated case definitions of IIM in the CPRD to characterise the epidemiology of IIM in the UK.
This cohort study aims to describe trends in myositis incidence and survival in the UK by
1. Developing and validating an algorithm to accurately detect IIM cases and subtypes within the CPRD.
2. Calculating the UK incidence of IIM, including crude as well as sex- and age-specific rates.
3. Evaluating changes in IIM incidence over time, including seasonality, and relationships with medication use.
4. Determining 5-year survival for IIM cases and any variation between IIM subgroupsCase validation will be carried out in an iterative process combining clinical review of a small number of cases with algorithmic rules using corroborating evidence from prescriptions, blood tests and referrals. Annual and monthly incidence rates, stratified by age and sex, with Poisson generalized additive regression models used to produce smoothed estimates of trends and seasonality. Five-year survival rates will be calculated using Kaplan-Meier estimates. The work in this study will inform future studies of myositis using CPRD.
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Epidemiology, clinical outcomes and healthcare resource utilisation associated with Barth Syndrome: A retrospective observational study in the Clinical Practice Research Datalink — Aron Buxton ...
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Epidemiology, clinical outcomes and healthcare resource utilisation associated with Barth Syndrome: A retrospective observational study in the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Aron Buxton - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Emillia Pierson - Collaborator - Atnahs Pharma UK Limited
Fernando Osorio - Collaborator - Atnahs Pharma UK Limited
Michael Withe - Collaborator - Atnahs Pharma UK LimitedOutcomes:
Incidence and prevalence of Barth syndrome; baseline characteristics; heart failure; cardiomyopathy; myopathy; cardiac transplantation; neutropenia; learning disability; infections; growth delay; all-cause mortality (survival); all-cause hospitalisation; outpatient attendance; primary care contacts; prescriptions; healthcare costs; treatment pathways.
Description: Lay Summary
Barth syndrome (BTHS) is a rare genetic disorder that predominantly affects boys from birth. It causes serious health problems, including a weakened heart muscle, frequent infections, poor growth, and muscle weakness. Patients with BTHS typically need care from several different specialists to manage these symptoms, yet current therapies do not address the conditionâs underlying cause. Because the disease is so uncommon, it can be overlooked during diagnosis and is not well recorded in electronic health databases. As a result, little real-world research is available on the impact of BTHS on patients and the health services they use.
In this study, we plan to select a group of people with BTHS from the Clinical Practice Research Datalink. We will find out how many have the condition and how many are newly diagnosed each year. We will describe their age, gender, other health problems, and any current or past medications. We will also look at how often they visit their doctor or hospital. Then, we will compare their rates of other illnesses and deaths with people who do not have BTHS but share a similar age, gender and GP practice location. We will estimate how much it costs to treat these patients.
By gathering this information, we aim to better understand how BTHS affects patients and how healthcare resources are used. This knowledge can help doctors, planners, and researchers develop improved care for those with BTHS, including new treatments that address its root cause, and more efficient healthcare systems.
Technical SummaryBarth syndrome (BTHS) is an extremely rare X-linked disorder of mitochondrial cardiolipin metabolism caused by pathogenic variants in TAFAZZIN. It often presents in infancy with cardiomyopathy, neutropenia, growth delay, and skeletal myopathy, resulting in high morbidity and mortality. Because there are no treatments available that address the underlying biochemical defect, management focuses on controlling clinical symptoms, often requiring multidisciplinary care (e.g., cardiology, haematology, nutrition, genetics).
This retrospective observational study will use the Clinical Practice Research Datalink (CPRD) Aurum and GOLD datasets, linked to Hospital Episode Statistics (HES) admitted patient care, outpatient, and accident and emergency data, and Office for National Statistics (ONS) death registration and index of multiple deprivation data. We will select all patients with recorded diagnoses of BTHS or equivalent codes (e.g., 3-methylglutaconic aciduria type 2, endocardial fibroelastosis type 2) or patients who meet an algorithm-based definition (e.g., early cardiomyopathy onset and relevant comorbidities, biochemical tests, and prescriptions). Patients will be followed from their practice registration date (index date) to the earliest of transfer out, death, or last data collection. Because BTHS is present from birth, no wash-in period will be required.
We will estimate annual incidence between 1st April 2003 and 31st September 2023, calculate point prevalence on 30th June 2023, and describe demographic and clinical characteristics. A matched control group (by age, gender, clinical practice, and concurrent registration) will facilitate comparisons of healthcare resource use and costs. Descriptive statistics will summarise cohort features; time-to-event models (e.g., KaplanâMeier, Cox regression) will be employed for survival outcomes. Sensitivity analyses based on different case definitions will evaluate robustness.
Findings will offer the first comprehensive, population-based assessment of BTHS in the UK, informing clinicians, policymakers, and researchers about its clinical and economic impact and providing baseline information for evaluating the cost-effectiveness of new interventions.
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Sex-differences in prescribing patterns of inhaled corticosteroids and outcomes in people with asthma — Jennifer Quint ...
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Sex-differences in prescribing patterns of inhaled corticosteroids and outcomes in people with asthma
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Hannah Li - Collaborator - Imperial College LondonOutcomes:
1) Proportion and frequency of prescribed ICS-specific medications.
2) Change in FEV1 decline pre and post ICS initiation.
3) Rate of exacerbations pre and post ICS initiation.Description: Lay Summary
Asthma is a common lung disease and is one of the most common diseases in the United Kingdom (UK). It can cause ongoing symptoms like breathlessness and coughing, which can make everyday life more difficult and reduce peopleâs quality of life. Research shows that adult females are more affected by asthma than males. Females tend to have more asthma attacks and are more likely to end up in hospital because of their asthma. They may also not respond to asthma treatments as well as males, and studies suggest there could be differences in how doctors prescribe these medicines to males and females. In this project, we aim to investigate whether males and females are prescribed, and respond to, a common asthma medicine, called inhaled corticosteroids (ICS), in different ways.
Using data from general practices (GPs) and hospitals in England, we will describe how often these medicines are prescribed to males and females. We will also determine whether this varies by factors like ethnicity, body weight, and how severe a personâs asthma is. To investigate whether males and females respond differently to the medicine, we will compare how well their breathing improves, also known as lung function, and how often they have asthma attacks before and after starting treatment.
Technical SummaryAsthma affects approximately 12% of the UK population and costing ~£3 billion annually. Females experience a disproportionate burden, with higher incidence, exacerbation rates, and re-hospitalisation compared with males. Limited evidence suggests that females may respond differently to inhaled corticosteroids (ICS), the cornerstone of asthma management, and patterns of ICS prescriptions by sex remain underexplored. The aim is to investigate sex differences in prescription patterns of and response to ICS in people with asthma.
To do this we will use primary care data from the Clinical Practice Research Datalink (CPRD) Aurum linked to hospital data using Hospital Episode Statistics (HES) Accident & Emergency and Admitted Patient Care in a retrospective cohort study of patients with a diagnosis of asthma aged 18 years old and older. The study period will be from the 1st of January 2010 to mid 2025 (i.e., the last CPRD Aurum collection date). First we will describe prescription patterns in ICS by sex in adults with asthma and the impact of ethnicity, socioeconomic deprivation, obesity, disease severity, incident or prevalent asthma, ICS dose and prescription length. Second, we will compare change in forced expiratory volume (FEV1) and asthma exacerbations pre and post ICS initiation by sex. Specifically, we will compare FEV1 decline and rate of exacerbations in the year prior to ICS initiation to that in the year following ICS initiation. ICS initiation will be the first recorded prescription of ICS following an asthma diagnosis. We will use mixed linear regression to compare yearly lung function decline pre and post ICS initiation adjusted for covariates and negative binomial regression to compare change in exacerbation rates pre and post ICS initiation by sex.
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Burden of Medically Attended Norovirus Gastroenteritis, in terms of incidence, healthcare resource utilization, and associated direct healthcare costs, in England between July 2013 and June 2024 — Chukwuemeka Onwuchekwa ...
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Burden of Medically Attended Norovirus Gastroenteritis, in terms of incidence, healthcare resource utilization, and associated direct healthcare costs, in England between July 2013 and June 2024
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Chukwuemeka Onwuchekwa - Chief Investigator - P95 BV (Belgium)
Nattha Kerdsakundee - Corresponding Applicant - P95 BV (Belgium)
Jehidys Montiel Ramos - Collaborator - P95 BV (Belgium)
MIKEL ESNAOLA - Collaborator - P95 BV (Belgium)
Scott McDonald - Collaborator - P95 BV (Belgium)
Worku Ewnetu - Collaborator - P95 BV (Belgium)Outcomes:
Primary outcomes: Total count of MA-AGE and MA-NGE episodes; Incidence rate of MA-NGE episodes; Proportion of MA-AGE episodes that are MA-NGE;
Secondary outcomes: 1-year HCRU; 1-year all-cause direct healthcare cost; 1-year all-cause mortality; Incremental HCRU within index episode, within 30 days and within 1 year; Incremental all-cause direct healthcare cost within index episode, within 30 days and within 1 year; All-cause mortality within 30 days following the index date or in-hospital NGE-associated mortality (inpatient only)
Exploratory outcomes: Stratification of primary objective outcomes by nosocomial versus community-acquired MA-AGE and MA-NGE infections.Description: Lay Summary
Norovirus causes gastroenteritis, leading to diarrhea, vomiting, nausea, and stomach pain. It spreads through contaminated food or water and can also be transmitted through air droplets. Symptoms usually appear 1-2 days after infection. The virus spreads quickly in crowded places like cruise ships, restaurants, and schools. Young children and the elderly are the most affected and may need hospital care. While the illness is generally not severe, it can spread widely, placing a high burden on the healthcare system.
Technical Summary
Currently, there is no vaccine for norovirus, but Moderna is developing one. To understand how this vaccine might help, we need to assess how norovirus affects the population in terms of health and costs. We also want to detect high-risk individuals and factors that may lead to severe infections. In this study, we will look back at health records from individuals in the CPRD database between 2013 and 2024. We will count the episodes of gastroenteritis and determine how many were due to norovirus. We will look at how often they happen and how they are spread out in the population over time. We will also check the costs linked to each episode in the year after, and compare these with individuals who did not have gastroenteritis. All personal information will remain anonymous. The findings will help in developing a better vaccine.This retrospective database study evaluates the burden of medically-attended acute gastroenteritis (MA-AGE) associated with norovirus (NoV) in England between 1 July 2013 and 30 June 2024. The primary objective is to estimate incidence rates of MA-AGE and MA-AGE associated with NoV (MA-NGE). Results will be stratified by age group, healthcare setting, NoV season, risk group based on chronic conditions, and COVID-19 pandemic periods. The study will assess direct healthcare costs, resource use (HCRU), and mortality as secondary objectives. Primary outcomes include the count and incidence rates of MA-AGE and MA-NGE episodes, and the proportion of MA-AGE episodes attributable to NoV. Secondary outcomes include healthcare cost, HCRU, and mortality within 1 year (postâMAâNGE episode), and the corresponding incremental values compared to a control population. Data will be sourced from Clinical Practice Research Datalink (CPRD) linked with secondary care datasets from NHS England, and mortality data from the Office for National Statistics.
The study includes all individuals registered in CPRD during the study period. Individuals aged â¥2 years must have â¥12 months of continuous CPRD registration. To assess underlying chronic conditions and account for reporting delay, data will be collected from 1 July 2012. MA-AGE and MA-NGE episodes will be identified based on Read, SNOMED CT, and/or ICD-10 codes. The control population for assessing incremental HCRU, costs, and mortality will comprise individuals registered in a GP practice that reports to CPRD matched to cases on age, sex, chronic conditions, and index date of the MA-NGE episode. Given the infrequent testing for NoV, MA-NGE incidence will be estimated directly and indirectly using a published regression modeling approach. Results will inform the development of Modernaâs NoV mRNA-vaccine candidate and help develop better strategies to prevent NoV, reducing the disease and economic burden of this infection in England and beyond.
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Determining health-related and service utilisation outcomes of referral using Advice and Guidance in patients with Parkinson's disease, inflammatory bowel disease, and systemic lupus erythematosus: a cohort study — Claire Burton ...
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Determining health-related and service utilisation outcomes of referral using Advice and Guidance in patients with Parkinson's disease, inflammatory bowel disease, and systemic lupus erythematosus: a cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CCG Pseudonyms; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-09
Organisations:
Claire Burton - Chief Investigator - University of Keele
Kayleigh Mason - Corresponding Applicant - University of Keele
Alice Faux-Nightingale - Collaborator - University of Keele
Christian Mallen - Collaborator - University of Keele
Clare Jinks - Collaborator - University of Keele
James Bailey - Collaborator - University of Keele
John Haines - Collaborator - Not from an Organisation
Kelvin Jordan - Collaborator - University of Keele
Lorna Clarson - Collaborator - University of Keele
Ram Bajpai - Collaborator - University of Keele
Rosie Harrison - Collaborator - University of Keele
Samantha Hider - Collaborator - University of Keele
Toby Helliwell - Collaborator - University of Keele
Victoria Welsh - Collaborator - University of KeeleOutcomes:
Objective 1: outcomes for those with a first recorded A&G and/or direct referral will be time to:
i. diagnosis of tracer condition (see Definition of Study Population)
ii. definitive medical treatment
iii. first outpatient appointmentObjective 2: outcomes were guided by Patient and Public Involvement and Engagement (PPIE), Stakeholder groups and interviews with GPs. They include in the 24 months following A&G and/or direct referral:
i. Number of consultations (CPRD Aurum);
ii. Number of prescriptions (CPRD Aurum);
iii. Number of referrals (CPRD Aurum);
iv. Number of outpatient appointments (HES outpatients);
v. Overnight unplanned hospital admissions (HES APC);
vi. Mortality (ONS).Description: Lay Summary
When a GP needs a specialistâs input with the care of a patient, they may make a direct referral to that specialist. Another option is to request Advice and Guidance (A&G). A&G is an electronic way for a GP to ask a specialist a clinical question. The response from the specialist may be to refer, to try a treatment, or do a test. A&G was introduced to speed up access to a specialist opinion and cut waits for outpatient care. A&G became more important during the COVID-19 pandemic as it meant patients did not automatically need to travel to a hospital. The use of A&G is now encouraged to help the NHS recover from the pandemic. There are few studies though telling us whether A&G has a better or worse effect on patient care than the usual referral system.
As part of a larger programme of work aiming to study the impact of A&G on patients, healthcare workers and the healthcare system, this study will describe how well A&G is working for patients and the NHS. We will use CPRD Aurum to find out if use of A&G rather than direct referral makes a difference to what happens to the patient. We will look at three example conditions: Parkinsonâs disease; inflammatory bowel disease; and lupus. We will see if A&G makes time to getting a diagnosis and receiving treatment any quicker than a direct referral, or if it means patients need to have more treatment from their GP and hospital.
Technical SummaryAdvice and Guidance (A&G) allows primary care clinicians to seek expert advice from a specialist, usually in an electronic format. Increasingly, rather than making a direct (elective outpatient) referral, clinicians are being encouraged to use A&G to reduce compound pressures on the NHS. Whilst A&G has been identified as a crucial part of managing NHS waiting lists, there is little evidence of its effectiveness in reducing these compound pressures. The potential longer-term risks of harm to patients, such as diagnostic delay, have not been considered.
The aim of our programme of work is to evaluate the impact of A&G on patients, clinicians, and the healthcare system. The objectives of this cohort study are to first, use propensity score-weighted flexible parametric survival analysis to compare time to diagnosis and treatment of tracer conditions (Parkinsonâs disease, inflammatory bowel disease, and systemic lupus erythematosus) in patients for whom A&G was used to those with direct referral without A&G. Second, to describe further variations in healthcare utilisation and patient burden (for example, further consultations, referrals and prescribing in primary care, death [Office for National Statistics], overnight hospitalisations [Hospital Episode Statistics (HES) Admitted Patient Care (APC)], outpatient appointments [HES outpatient]) comparing A&G and direct referral pathways. Propensity score weighting will be used to balance the two groups on covariates including age, sex, patient-level Index of Multiple Deprivation (IMD), CPRD Aurum ethnicity record, Clinical Commissioning Group, multimorbidity, polypharmacy and frailty.
Other components of this multistage mixed-methods programme are analysis of the patterns of use of A&G over time using CPRD Aurum and linked data (CPRD protocol #24_004022), alongside qualitative research which will explore the experience and perspectives of A&G from patients, clinicians, and commissioners. This will help determine whether A&G reduces waiting times and access to specialist care as planned, without impacting the quality of care.
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Risk Factors for Suicidal Behaviour in People with Dementia — Tom Marshall ...
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Risk Factors for Suicidal Behaviour in People with Dementia
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Tom Marshall - Chief Investigator - University of Birmingham
Yin-Ting Chen - Corresponding Applicant - University of BirminghamOutcomes:
Primary outcome: suicidal behaviour (recorded attempted or completed suicide).
Secondary outcomes: hospital admissions related to attempted suicide; completed suicide confirmed through ONS mortality data; time to first recorded suicidal behaviour; mortality from other causes as a competing risk.
Description: Lay Summary
Suicidal behaviour is a serious public health concern, particularly among people living with dementia. Dementia is one of the most common conditions affecting older adults, and as the population ages, the number of people diagnosed continues to rise. This presents significant challenges for individuals, families, healthcare systems, and policymakers.
This study aims to explore whether certain risk factors found in an earlier review are linked to suicidal behaviour in people with dementia. To do this, we will use information from the Clinical Practice Research Datalink, a large and reliable database containing anonymised health records from general practices across the United Kingdom. By analysing this information, we hope to gain a better understanding of how these risk factors influence the likelihood of suicidal behaviour in this group.
The findings from this research could help improve support for people with dementia by informing healthcare professionals, carers, and policymakers about key risks. This may lead to better approaches for early intervention, mental health support, and policy development, ultimately improving the wellbeing and safety of people with dementia. The study could also provide valuable insights for those involved in dementia care, including families, social care providers, and long-term care organisations.
Technical SummaryThis study aims to examine the association between risk factors and suicidal behaviour (SB) in people with dementia (PwD) using data from the Clinical Practice Research Datalink (CPRD), a large database of anonymised electronic health records from general practices across the UK. The study will focus on adults aged 18 and over who are registered with CPRD practices. Risk factors previously identified in a systematic review will be assessed for their relevance in this population.
A retrospective cohort study will be conducted, including individuals diagnosed with dementia. The primary outcome will be SB, defined as attempted or completed suicide. The exposure variables will be risk factors identified in the review, including demographic, clinical, and social characteristics. The study start date will be the later of the year 1995 or the CPRDâs acceptable mortality reporting date (STANDARD_DATE1), and follow-up will continue until the earliest of: the study end date (up to the most recent data available) or death.
Cox proportional hazards regression will be used to estimate the association between these risk factors and time to first recorded SB. Proportional hazards assumptions will be evaluated using Schoenfeld residuals. To account for the high mortality risk in PwD, competing risks regression will be used, treating non-suicide death as a competing event. Missing data will be addressed using multiple imputation if appropriate. Sensitivity analyses will assess the robustness of findings, including the impact of alternative definitions of SB.
Linked Office for National Statistics (ONS) mortality data will confirm deaths by suicide. Ethnicity and patient-level deprivation data will be used to explore disparities. Findings may inform clinical guidelines, improve risk assessments, and support targeted interventions for this vulnerable population.
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Update of the type 2 DIabetes Severity SCOre (DISSCO) in general practice electronic health records in England: a retrospective cohort study. — Salwa Zghebi ...
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Update of the type 2 DIabetes Severity SCOre (DISSCO) in general practice electronic health records in England: a retrospective cohort study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-02
Organisations:
Salwa Zghebi - Chief Investigator - University of Manchester
Sarah McDiarmid - Corresponding Applicant - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Mamas Mamas - Collaborator - University of KeeleOutcomes:
The primary outcome is all-cause mortality of people with type 2 diabetes (T2D).
The secondary outcomes are diabetes-related mortality; cardiovascular-related mortality; hospitalisations of people with T2D: for any cause, diabetes, cardiovascular, clustered cardiovascular and diabetes, cardiovascular procedures and Major Adverse Cardiovascular Events (MACE) (death, myocardial infarction and stroke); remission from T2D; incidence of depression; and incidence of anxiety.
Deaths will be identified by linkage to ONS death registration data using the ICD-10 coding system. Cause-specific hospitalisation will be identified by linkage to the HES Admitted Patient Care database using the ICD-10 and OPCS-4 coding systems.
Description: Lay Summary
Type 2 diabetes is a condition that causes high blood sugar levels. When type 2 diabetes becomes more serious it leads to greater pressure on the patient and the NHS. There is no measure of how serious someoneâs type 2 diabetes is other than the blood sugar test âHbA1câ which changes over time and does not show the range of health problems connected to type 2 diabetes.
Our team have created the type 2 DIabetes Severity SCOre âDISSCOâ based on information in a patientâs GP medical record. DISSCO measures how serious someoneâs type 2 diabetes is based on whether they have health problems connected to their diabetes e.g. those affecting their eyes, feet, kidneys and heart. We found that people with type 2 diabetes and higher DISSCO scores were more likely to be admitted to hospital or die compared to people with type 2 diabetes and a lower score. Knowing someoneâs DISSCO score tells you more about their chance of being admitted to hospital or dying than knowing their HbA1c.
DISSCO could help to work out which patients with type 2 diabetes need greater care. DISSCO could also be used by researchers to help understand the impact of type 2 diabetes on health.
This current project will explore whether we can improve DISSCOâs ability to predict poor physical and mental health by adding more information about a patient into the DISSCO score e.g. how long someone has had their diabetes, their diabetes medications, their body weight and whether they smoke.
Technical SummaryBackground and Aim
Increasing Type 2 diabetes (T2D) severity is associated with morbidity and mortality and leads to a greater burden on the individual and healthcare resources. Glycated haemoglobin (HbA1c) is commonly used as a proxy for T2D severity however it fluctuates over time and cannot capture the impact of T2D on multiple body systems.We have developed a novel type 2 DIabetes Severity SCOre (DISSCO) using data from CPRD GOLD linked to HES and ONS death registration data in England. DISSCO includes 34 indicators of T2D severity including diabetes complications, cardiovascular risk factors and interventions. A cohort study of 139,626 adults aged â¥35 between 2007 and 2017 showed that a one-unit increase in baseline DISSCO was associated with a 14% increased of mortality and 45% increased risk of hospitalisation. DISSCO had better predictive value of these events than HbA1c alone.
DISSCO could be used to stratify patients with T2D to target care, resource and benchmark services. DISSCO could also be an important covariate or outcome measure in epidemiological research.
We have conducted a literature review which has identified additional indicators of T2D severity that may be missing from DISSCO.
Methods and analysis
This current study aims to update DISSCO by using CPRD Aurum data between 2014 and 2024 linked to HES and ONS mortality data to assess whether additional indicators of T2D severity such as diabetes duration, complexity of diabetes medication and health behaviours (e.g. alcohol intake and smoking status) improve the predictive value of DISSCO. DISSCOâs ability to predict other outcomes such as remission from T2D and incidence of depression and anxiety will also be assessed. Subsequent work to externally validate DISSCO in a separate database will inform implementation of DISSCO in general practice systems.
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Evidence on the efficacy and safety of medication use during pregnancy: data from Clinical Practice Research Datalink — Gemma Clayton ...
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Evidence on the efficacy and safety of medication use during pregnancy: data from Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-23
Organisations:
Gemma Clayton - Chief Investigator - University of Bristol
Faye Cleary - Corresponding Applicant - University of Bristol
Deborah Anne Lawlor - Collaborator - University of Bristol
Elisabeth Aiton - Collaborator - University of Bristol
Maria Carolina Borges - Collaborator - University of Bristol
Peiyuan Huang - Collaborator - University of Bristol
Rosie Cornish - Collaborator - University of BristolOutcomes:
Variables investigated for initial descriptive work (objective 1) are:
- Medication prescribing in and around pregnancy
- Timing of medication discontinuation, initiation or switchingEfficacy and safety outcomes for causal analyses (objectives 2 and 3) are: miscarriage, stillbirth, congenital malformations, gestational hypertension, pre-eclampsia, high birthweight/low birthweight, small for gestational age (SGA), large for gestational age (LGA), induction of labour, caesarean section (elective/emergency), preterm birth (PTB; spontaneous/indicated), low Apgar at 5 minutes, neonatal intensive care unit (NICU) admission, neonatal hypoglycaemia, (maternal, infant, neonatal) mortality, perinatal depression, hyperemesis. Selection of primary and secondary outcomes depends on specific medications and indications (Appendix 3).
Description: Lay Summary
Women of child-bearing age are affected by conditions such as diabetes, hypertension, thyroid disorders and autoimmune conditions. Outside of pregnancy, these women will benefit from effective treatments, but we donât know if it is safe to use these medications during pregnancy. This is because allocating pregnant women to a medication in a clinical trial raises ethical concerns about the possible effect on the fetus. This means that doctors, midwives and women/couples do not know the pros and cons of stopping medication for a condition, such as diabetes, changing the medication or continuing with it.
There is variation in prescribing of different medications in pregnancy, which may reflect differences between healthcare providers and in what women/couples perceive to be safe, the availability of alternatives to the medications and previous own, family or friendsâ experience.
Our aim is to assess whether medications used to reduce risks of diabetes, high blood pressure, high cholesterol, autoimmune conditions and high thyroxin levels are useful and safe in pregnancy. We will explore medication prescribing patterns, and whether these change over time and differ in women of different age, affluence and ethnicity. We will generate evidence on benefits and safety of medications used to reduce the risk of conditions listed in our aim. We will also investigate the impact of underlying conditions themselves on pregnancy outcomes, which will help demonstrate the suitability and/or importance of medications during pregnancy in affected women. This work may lead to changes in clinical practice that benefit women and their children.
Technical SummaryPregnant women often need medication to manage pre-existing conditions, which they may be taking before knowing they are pregnant. Concerns about harm to the developing fetus mean that pregnant women are often excluded from randomised controlled trials (RCTs). This leads to limited evidence on efficacy and safety of medications for both mother and baby, with few drugs approved for pregnancy use. This leaves pregnant women vulnerable to unknown medication risks and difficult decisions about treatment. Our aim is to assess the efficacy and safety of hypoglycaemic, antihypertensive, monoclonal antibody, lipid lowering, and thyroid medication use in pregnant women with pre-existing conditions. We will first describe current prescribing before, during, and after pregnancy and then use a range of novel causal inference methods, each with different sources of bias, to triangulate evidence on safety and efficacy.
All women with a record of pregnancy and registered at a GP practice for at least one year prior to pregnancy will be included. Other criteria may be applied for specific questions/methods. A range of pregnancy-related outcomes will be investigated. Both primary care and hospital data will be used to maximise capture of relevant data. We will compare results from different methods with different key sources of bias including conventional multivariable regression, within-women analyses, physician prescribing preference (PPP) instruments and target trial emulation (TTE). Negative and positive controls will be used to further explore biases across methods. This research aims to strengthen causal evidence of drug efficacy and safety during pregnancy, to support policy makers providing guidance on medication usage, and individual women and their healthcare providers to make better informed decisions on medication use in and around pregnancy.
Throughout this protocol, references to medication use refers to hypoglycaemic, antihypertensive, monoclonal antibody, lipid lowering, and thyroid medications (listed in Appendix 1), unless specified otherwise.
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Examining prescribing trends and the risk of adverse events in patients taking opioids: a cohort study based on linked primary care data in England — Eleni Domzaridou ...
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Examining prescribing trends and the risk of adverse events in patients taking opioids: a cohort study based on linked primary care data in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-20
Organisations:
Eleni Domzaridou - Chief Investigator - University of Oxford
Eleni Domzaridou - Corresponding Applicant - University of Oxford
Ben Lacey - Collaborator - University of Oxford
Isaac Ogunkola - Collaborator - University of Oxford
Yangmei Li - Collaborator - University of OxfordOutcomes:
Primary outcome measure: Opioid prescription trends.
Secondary outcomes measure:
⢠Frequency of hospital admissions;
⢠All-cause mortality;
⢠Hospital discharge and/or mortality due specific causes using ICD codes (e.g., overdose, cardiovascular diseases, liver diseases, respiratory diseases, external causes of morbidity and mortality).Description: Lay Summary
Pain affects one in five adults worldwide, with many newly diagnosed with long-term pain each year. Opioids, such as morphine and codeine, have been used for decades to manage pain, particularly for serious illnesses and palliative care. However, there is little evidence that they are effective for long-term pain, and prolonged use can lead to serious risks, including addiction, overdose, and death. The UK uses more opioids per person each day than any other country in the world, but the reasons behind this trend are not well understood. This study will investigate whether increasing opioid prescriptions are linked to an ageing population with more health conditions and pain-related needs and look at potential link between opioid prescriptions and health outcomes.
Using anonymised primary care records linked to hospital and death records, we will retrieve electronic health records of patients prescribed opioids and track their treatment patterns. We will examine key health outcomes, such as hospital admissions and death, to assess the risks of opioid use. Our analysis will consider factors such as age, sex, ethnicity, socioeconomic status, and existing health conditions. By understanding opioid prescribing trends, this research aims to inform safer prescribing practices and improve pain management strategies, reducing potential harms for patients.
Technical SummaryPain is a major global health issue, affecting approximately 20% of adults, with 10% newly diagnosed with chronic pain annually. Opioid analgesics remain the cornerstone for pain management, palliative care, and opioid dependence treatment. Despite their widespread use, opioids lack robust evidence for chronic pain management and are associated with adverse outcomes, including overdose, dependence, and mortality. The UK has the highest global opioid consumption rates (measured as morphine milligram equivalents per 1,000 inhabitants per day), yet opioid prescribing patterns remain poorly understood in relation to broader healthcare needs. This study aims to investigate the sociodemographic, and health-related determinants of increasing opioid prescriptions in the UK, focusing on whether this trend is driven by an ageing population with higher pain management needs and inform targeted interventions to optimise opioid use in clinical practice.
Exposure Definition: Prescription data from CPRD Aurum will be used to retrieve electronic health records of adult patients prescribed opioids in primary care across England between January 2010 and December 2022 to delineate the study cohort. Treatment episodes will be defined based on prescription issue dates, with imputation methods applied to address missing data on treatment duration.
Outcomes: Primary outcomes include all-cause mortality and hospital admissions. Secondary outcomes involve cause-specific mortality and hospital discharge diagnoses.
Covariates/Analysis: Opioid dosage will be converted to morphine equivalents. Propensity score will be calculated to balance baseline characteristics between the comparison groups. Multivariable regression models will adjust for sociodemographic, clinical, and prescribing factors. Incidence rates of hospital admission/mortality will be estimated using Poisson regression with stratification by calendar year, opioid strength (weak; moderate; strong), drug substance, and treatment status (in/out). Practice-level variation will be assessed using multi-level models. Sensitivity analyses will address exposure misclassification by modification of the opioid exposure definition in terms of duration, grace periods applied, and treatment gaps.
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Cardiovascular Risk Stratification in Multimorbid Patients with Cancer: Treatment Interactions, Health Disparities, and Healthcare Utilisation Patterns — Amitava Banerjee ...
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Cardiovascular Risk Stratification in Multimorbid Patients with Cancer: Treatment Interactions, Health Disparities, and Healthcare Utilisation Patterns
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-22
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Ashkan Dashtban - Corresponding Applicant - University College London ( UCL )
Arjun Ghosh - Collaborator - Barts Health and UCLH NHS Trusts
Beiyi Su - Collaborator - University College London ( UCL )
Evridiki Georgaki - Collaborator - University College London ( UCL )
Kunyue Xing - Collaborator - University College London ( UCL )
Laura Pasea - Collaborator - University College London ( UCL )
luyaoo Tian - Collaborator - University College London ( UCL )
Mohamed Mohamed - Collaborator - University College London ( UCL )
Richard Corbett - Collaborator - Imperial College Healthcare NHS Trust
Shijia Lin - Collaborator - University College London ( UCL )Outcomes:
Primary Outcome:
6. Incidence of Cardiovascular Disease (CVD): This includes the occurrence of major adverse cardiovascular events (MACE14,15), defined as a composite of stroke, myocardial infarction, and cardiac death.
Secondary Outcomes:
7. Individual Components of MACE: Stroke, myocardial infarction, and cardiac death analyzed separately to identify specific risks associated with CKD and cancer.
8. All-Cause Mortality: Death from any cause, providing insights into overall survival.
9. Hospitalization Rates: Frequency of hospital admissions, particularly those related to cardiovascular events.Description: Lay Summary
As people age, they often develop multiple long-term health conditions, such as kidney disease, lung disease, diabetes, and liver disease, which increase the risk of heart disease. Cancer diagnosis further elevates this risk due to effects of cancer treatments and interactions with existing health issues. This research aims to improve our understanding of heart disease in people with multiple conditions, particularly those diagnosed with cancer, to enhance disease management and patient outcomes.
Technical Summary
1. Understanding How Often Heart Disease Occurs â Investigating how common heart disease is among people with long-term conditions and investigating the factors that increase risk.
2. Assessing Cancer Treatments and Medication Conflicts â Exploring how cancer treatments impact heart health and identifying harmful medication interactions.
3. Understanding High Risk of Heart Disease â Using advanced computer models to predict which patients are most likely to experience serious heart problems.
4. Exploring Health Inequalities â Examining how factors such as income, access to healthcare, and location affect the risk of heart disease.
5. Examining Healthcare Access â Studying how patients access healthcare services, including hospital visits and end-of-life care, to inform better healthcare planning.
The study will analyse large national health databases, applying statistical methods and artificial intelligence to detect patterns and predict risks. Findings will help doctors make better treatment decisions, reduce harmful medication interactions, and ensure healthcare services are targeted to those who need them most. Ultimately, the research aims to improve heart health outcomes for people with multiple long-term conditions, particularly those affected by cancer.As populations age, the burden of multimorbidity increases, leading to a higher prevalence of cardiovascular disease (CVD) alongside chronic conditions such as chronic kidney disease, chronic liver disease, diabetes, and chronic respiratory disease 1â6. The development of cancer in these patients further complicates CVD risk management due to the cardiotoxic effects of cancer therapies, complex interactions between pre-existing conditions, and healthcare disparities 7â10. Despite its clinical significance, the interplay between cancer, chronic conditions, and CVD remains underexplored in large-scale studies 11â13. This research aims to address these gaps through:
⢠Assessing the incidence, progression, and outcomes of CVD in multimorbid patient groups, identifying key demographic, clinical, and socioeconomic risk factors.
⢠Investigating (a) the effectiveness of cancer therapies in different multimorbid patient clusters, (b) medication conflicts to identify optimal treatment combinations, and (c) interactions between prescribed medications, therapies, and chronic diseases.
⢠Developing and validating machine learning-based risk prediction models to stratify patients at high risk of severe cardiovascular events, accounting for competing risks and dynamic treatment pathways to enable targeted preventive strategies.
⢠Analysing the impact of socioeconomic deprivation, healthcare access, and geographic disparities on CVD risk and outcomes.
⢠Investigating patterns of healthcare use, including hospitalizations, primary care visits, and palliative care access, to inform service provision and policy development.We will use linked electronic health records, primary care data (CPRD), hospital admissions (HES), death registry data (ONS) to define a cohort of patients with cancer and chronic disease, and comparator cancer-only and chronic disease-only groups.
This research will generate novel insights into CVD risk stratification, conflicts in treatment, health inequalities, and healthcare utilisation. Findings will inform clinical decision-making, support personalised treatment approaches, and guide healthcare policy to optimise outcomes in multimorbid patients.
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Trends in cause-specific mortality and major clinical outcomes in patients with atrial fibrillation — Safoora Gharibzadeh ...
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Trends in cause-specific mortality and major clinical outcomes in patients with atrial fibrillation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-19
Organisations:
Safoora Gharibzadeh - Chief Investigator - University of Leicester
Safoora Gharibzadeh - Corresponding Applicant - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Navjot Kaur - Collaborator - University of Leicester
Patrick Rockenschaub - Collaborator - Medical University of Innsbruck
Peter Willeit - Collaborator - Medical University of Innsbruck
Sharmin Shabnam - Collaborator - University of Leicester
zahra karimi - Collaborator - Leicester Diabetes CentreOutcomes:
All-cause mortality; cause-specific mortality (cerebro- and cardiovascular, cancer, mental or neurological, other); hospitalisation for a major adverse event associated with AF or treatment for AF (stroke, bleeding, myocardial infarction, heart failure).
Description: Lay Summary
Atrial fibrillation (AF) is a common heart rhythm disorder that increases the risk of severe health issues like stroke, heart failure, and even death. This study aims to understand how modern treatments for AF have affected patient outcomes over the past two decades in the UK. We will compare patients newly diagnosed with AF to those without AF, looking at how death rates and serious health events have changed, especially since the introduction of newer blood-thinning medications in 2010. By using patient data from primary care records, hospital admissions, and mortality records, we hope to provide valuable insights that can improve patient care and health policies. Our study will focus on differences in outcomes such as overall mortality, specific causes of death, and hospitalizations due to major health events. Ultimately, our findings could help shape future treatment strategies and health policies to better manage AF and improve patient outcomes.
Technical SummaryThis study will conduct a retrospective observational cohort analysis to assess the impact of contemporary atrial fibrillation (AF) management on mortality and major adverse events in the UK. Utilizing data from CPRD GOLD and Aurum, HES APC, and ONS, we will compare patients newly diagnosed with AF against controls without AF from 2001 to 2024. Primary outcomes include 1-year all-cause mortality, cause-specific mortality (cerebrovascular, cardiovascular, cancer, mental/neurological, other), and hospitalizations due to major adverse events associated with AF or its treatment (stroke, bleeding, myocardial infarction, heart failure). To obtain suitable controls, the study will match (with replacement) up to 5 controls who do not yet have an AF diagnosis. Patients may be matched more than once and may act both as cases and controls. The statistical analysis will estimate changes in the excess risk of AF over time using a Royston-Parmer model, accounting for baseline covariates and potential confounders. The study will employ bootstrapping to obtain valid 95% confidence intervals (CI). Sensitivity analyses will test the robustness of the findings, including investigating effects in the period after 2008 and prior to COVID-19, for 3-year outcomes, and for men and women separately. The results aim to inform clinical practice and health policies by providing evidence on the real-world effectiveness of AF management strategies over the last two decades.
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A cohort study to compare pregnancy and perinatal health outcomes of mothers with systemic lupus erythematosus, and their babies, with the general population — Anita McGrogan ...
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A cohort study to compare pregnancy and perinatal health outcomes of mothers with systemic lupus erythematosus, and their babies, with the general population
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-08
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Christine MacFadyen - Collaborator - University of Bath
Sarah Skeoch - Collaborator - University of Bath
Sarah Tansley - Collaborator - University of BathOutcomes:
Primary outcomes: rates of pregnancy; livebirths; stillbirths; miscarriage; termination of pregnancy; major congenital malformations
Secondary outcomes: neonatal mortality; thromboembolic event; maternal mortality; postpartum depression, anxiety or psychosis; emergency caesarean delivery; premature delivery; length of hospital stay post-delivery; re-admission to hospital within 28 days of delivery; low birth weight; neonatal heart block; mode of delivery; postpartum haemorrhage; postpartum infection; peripartum transfusion.
Description: Lay Summary
Systemic lupus erythematosus (lupus) is an autoimmune disease which most often affects women at an age when they might become pregnant. Studies in other countries have found that women with lupus are more likely to have problems during pregnancy than healthy women without lupus. These studies, however, have often been done with small groups of women who are being looked after in specialist hospitals and do not accurately reflect the care most women with lupus receive during pregnancy. Little is also known about whether there are differences in what happens to pregnant women with lupus and their children, among different ethnic and socioeconomic groups.
The aim of this study is to look at the rates of pregnancy and live births in women with lupus and compare them to women without lupus. We will also look to see if women with lupus are more likely to have problems during pregnancy (such as a miscarriage or stillbirth) or soon after pregnancy (such as depression or health problems in the baby) than women without lupus. We will also look to see if there are any medicines, or other factors such as medical conditions or smoking that make women with lupus more likely to have problems during or soon after pregnancy.
This study will provide important information for doctors and women with lupus who are thinking about becoming pregnant. It will also find areas where healthcare for pregnant women with lupus can be made better.
Technical SummarySystemic lupus erythematosus (lupus) is an autoimmune disease which most commonly affects women of childbearing age. It is recognised that lupus patients are at higher risk of adverse pregnancy outcomes but there are few published data that are UK specific, representative and evaluate both maternal and foetal outcomes after birth. There is also recognition of differences in maternity outcomes among different ethic and socioeconomic groups which may have a significant impact on lupus outcomes.
This study aims to describe rates and outcomes of pregnancy in lupus patients compared to the general population. It also aims to identify any factors which may be associated with adverse outcomes including ethnicity, socioecomonic status, comorbidities and lupus related factors such as medications. The study will use anonymised data from CPRD Aurum between 2000 and 2025. Women with â¥1 pregnancy and a diagnosis of lupus will be eligible for inclusion and will be compared to all other women with a pregnancy who do not have lupus.
The rates of pregnancy in women with and without a diagnosis of lupus before pregnancy will be calculated. Population characteristics will be described as percentages for the lupus and non-lupus cohorts and compared using Chi-squared tests. Patterns of prescribing to women with lupus will be described in 3-month periods for the year leading up to pregnancy, each pregnancy trimester and the year following pregnancy. For each adverse pregnancy and maternal outcome of interest conditional logistic regression will be used to determine the likelihood of an adverse pregnancy outcome in women with lupus compared to women without lupus. For pregnancy losses, a Cox proportional hazards model with left truncation at 8 weeks will be used.
This study will provide valuable information for UK lupus women who are considering pregnancy and identify areas where lupus maternity care can be improved.
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The association between levothyroxine treatment and the risk of metabolic dysfunction-associated steatotic liver disease among people with subclinical hypothyroidism — Samy Suissa ...
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The association between levothyroxine treatment and the risk of metabolic dysfunction-associated steatotic liver disease among people with subclinical hypothyroidism
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-19
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Christel Renoux - Collaborator - McGill University
Christopher Filliter - Collaborator - Lady Davis Institute of the Jewish General Hospital
Giada Sebastiani - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Lady Davis Institute of the Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Our primary outcome will be incident MASLD.
Our secondary outcomes will be MASH, cirrhosis, and hepatocellular carcinoma (HCC).Description: Lay Summary
Subclinical hypothyroidism (SCH) is a condition that is frequently found during routine screening. This condition is characterized by a mildly low thyroid hormone level, which usually does not cause symptoms but its long-term effects on human health is unknown. SCH has been shown to be associated with metabolic factors, including increased cholesterol levels, higher blood pressure and increased risk of weight gain. These metabolic changes may be associated with an increased risk of developing fatty liver disease (i.e., metabolic dysfunction-associated steatotic liver disease [MASLD]). MASLD is a chronic condition, which may eventually lead to complications such as cirrhosis (liver failure) or hepatocellular carcinoma (liver cancer). Studies have shown that people with SCH have a higher risk of developing MASLD. However, whether treatment of SCH is associated with a decreased risk of MASLD is unknown.
Technical Summary
The objective of our study will be to determine whether treatment of SCH is associated with the risk of MASLD. We will use a database conduct statistical analyses to determine whether treatment of SCH is associated with a decreased risk of MASLD compared to no treatment. Our study will also determine whether treatment of SCH affects the risk of developing cirrhosis and hepatocellular carcinoma. This will be the first study using real-world data to address whether treatment of SCH is associated with the risk of MASLD.Overall objective: To determine whether levothyroxine treatment is associated with the risk of metabolic dysfunction-associated steatotic liver disease (MASLD) among people with subclinical hypothyroidism (SCH).
Overview: SCH affects approximately 5 to 10% of the population globally. SCH is a result of a mildly insufficient level of thyroid hormone and rarely causes symptoms. There is uncertainty on whether this condition should be treated. Thyroid hormones have been shown to affect lipid metabolism of the liver, which can result in hepatic lipid accumulation, leading to increased oxidative stress and inflammation. As such, there is evidence that people with SCH have a higher risk of developing MASLD. MASLD is a chronic liver condition, which develops in the presence of steatosis that can progress to metabolic dysfunction-associated steatohepatitis (MASH). Given that thyroid hormone potentially affects the lipid metabolic pathways leading to MASLD, there is need to determine whether levothyroxine treatment of SCH decreases the risk of developing this condition.
Methods: We will use data from the Clinical Practice Research Datalink (CPRD) Aurum, a large primary care database from the United Kingdom to conduct a population-based cohort study. We will assemble a cohort of individuals with SCH newly initiated on levothyroxine between 1998 and 2023, followed until December 2024. We will use a prevalent new user time-conditional propensity score matched analysis to estimate the hazard ratio and corresponding 95% confidence interval of incident MASLD among levothyroxine treated versus non-treated individuals with SCH.
Expected Outcomes: SCH has been shown to be associated with a higher risk of MASLD, which is a chronic liver condition that is associated with increased morbidity and mortality. Currently, treatment of SCH is controversial. Our proposed study will be the first study to address whether treatment of SCH reduces the risk of developing MASLD and subsequent complications associated with this disease.
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Exploiting instrumental variables to estimate the effects of time-varying treatments using routine data — Manuel Gomes ...
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Exploiting instrumental variables to estimate the effects of time-varying treatments using routine data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CCG Pseudonyms
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-28
Organisations:
Manuel Gomes - Chief Investigator - University College London ( UCL )
Manuel Gomes - Corresponding Applicant - University College London ( UCL )
Daniel Tompsett - Collaborator - University College London ( UCL )
Philip Stone - Collaborator - University College London ( UCL )
Stephen Roderick - Collaborator - University College London ( UCL )Outcomes:
Primary outcome:
- Blood glucose (Hb1Ac)
Secondary outcomes:
- Body mass index (BMI);
- Systolic blood pressure;
- estimated glomerular filtration rate (eGFR)
- Hospital admissions;
- Hospital length-of-stay;
- Major cardiovascular events: stroke, myocardial infarction, cardiovascular-related death;
- all-cause mortality.Description: Lay Summary
Evidence from clinical trials plays a central role in the evaluation of the benefits and harms of treatments provided in the NHS, but for many of them, trial-based evidence is unavailable or insufficient. Government agencies are increasingly using patient data collected routinely in hospitals, general practices, and disease registers, for complementing evidence from trials. However, studies that use routine data for evaluating the benefits of treatments are prone to biases due to both observed and unobserved differences between patient groups receiving different treatments. Policy makers are worried that these potential biases may lead to wrong treatment decisions and poor allocation of healthcare resources.
Technical Summary
This research addresses these concerns by exploiting an approach, known as instrumental variables (IV) analysis, widely used in social sciences for addressing both observed and hidden biases. IV analysis essentially involves using variables, known as 'instruments' (for example, genetic factors) that affect the treatment patient receives but have no effect on health outcomes, except through the treatment itself. IV methods can play an important role in obtaining robust evidence from routine data, but the application of IV methods in these studies remains poorly understood. Existing IV methods are not appropriate for evaluating the effects of treatments sustained over time, which requires controlling for differences between treatment groups that vary over time. This project will assess the validity and usefulness of IV analysis to control for these biases over time in studies that use routinely data for evaluating the benefits of treatments.Decision makers are increasingly using routine data to evaluate health interventions when evidence from clinical trials is limited or unavailable. This has been particularly relevant to the evaluation of treatment strategies sustained over time due to the limitations of trials regarding the duration of follow-up and treatment adherence. The ability to derive valid estimates of sustained treatment effects from routine data critically depends on adequate control of both measured and unmeasured confounding, at each point in time. This study proposes instrumental variable (IV) methods to address this by exploiting sources of variation, known as 'instruments' (for example, prescribing preferences), that explain treatment assignment but have no direct effect on outcomes.
We illustrate the opportunities and challenges raised by routine data for estimating time-varying treatment effects in an evaluation of alternative second-line treatments for patients with type-2 diabetes. Our case study will include individuals with type-2 diabetes, aged 18 or over, and with at least one prescription for metformin monotherapy and one other antidiabetic medication (sulfonylureas, dipeptidyl peptidase-4 inhibitors and sodium-glucose co-transporter-2) in primary care between 1 January 2012 and 31 December 2024. The prospective study will emulate a hypothetical trial that evaluates the effectiveness of second-line anti-diabetic treatments. The primary outcome of interest will be absolute change in HbA1c at 12 months follow-up. We will use IV analysis to minimise the risk of biases due to unmeasured confounders, such as, diet and exercise. The instrument will be the primary care providersâ tendency to prescribe the different second-line treatments.
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Investigating whether proposed new NICE (National Institute for Health and Care Excellence) indicators for people with asthma at risk of poor outcomes can be measured using general practice data — Jonathan Wray ...
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Investigating whether proposed new NICE (National Institute for Health and Care Excellence) indicators for people with asthma at risk of poor outcomes can be measured using general practice data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-21
Organisations:
Jonathan Wray - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Helen Chamberlain - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Diagnoses of asthma; comorbidity diagnoses (severe mental illness, obesity, depression, gastro-oesophageal reflux disease, anxiety, chronic rhinosinusitis, atopic eczema, nasal polyposis, obstructive sleep apnoea, vocal cord dysfunction); asthma medication prescriptions, A&E visits, hospital admissions, smoking status, annual asthma review rates.
Description: Lay Summary
The National Institute for Health and Care Excellence (NICE) develops ways of measuring the quality of healthcare, called indicators. These can help show whether some people arenât receiving the recommended care for their condition and help establish where improvements are needed. Before rolling out these new indicators, we need to check it is possible for them to be measured using the data contained in General Practice (GP) health records.
Asthma is a common condition that impacts how well a person can breathe. Some people have more severe symptoms of their asthma and are more likely to experience poor outcomes such as needing to spend time in hospital or death. There are some key signs that someone might be at risk of poor outcomes, such as needing to take very strong asthma medications or visit Accident and Emergency (A&E) multiple times a year, but other people are at risk because they smoke or have other health conditions that can make it harder to control their asthma.
To make sure patients are getting the right support, the suggested indicators will measure how many people who are at risk of poor outcomes;
Have had a regular asthma check up in the last 12 months
Have been given the recommended treatment option
Technical SummaryThis project will investigate two potential new General Practice (GP) level indicators for people with asthma most at risk of poor outcomes. These indicators are being assessed for suitability for use in the Quality and Outcomes Framework (QOF) and would complement the current four asthma indicators already in use. It is necessary to assess whether the proposed indicators are suitable and measurable using primary care data.
We will conduct a retrospective observational cohort study using data from CPRD Aurum. We will select a cohort of patients on the asthma register who have an additional risk factor for poor outcomes (such as needing to spend time in hospital or death). Within this population we will aim to estimate:
The percentage of patients who have had an asthma review in the preceding 12 months
The percentage of patients who are receive maintenance and reliever therapy (MART)
Use of the indicators, if determined to be measurable, could help give service providers an understanding of how asthma is managed within the context of what is considered best practice. Focusing on those at highest risk of poor outcomes will benefit patients by ensuring that those most at need are supported to manage their asthma more effectively, reducing the impact of poor health for those individuals and reducing system strain caused by poorly controlled asthma.
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Assessing Inequities in Hyperglycaemic Outcomes Care and Outcomes in the UK: A Population-Based Cohort Study — Punith Kempegowda ...
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Assessing Inequities in Hyperglycaemic Outcomes Care and Outcomes in the UK: A Population-Based Cohort Study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Punith Kempegowda - Chief Investigator - University of Birmingham
Aspasia Manta - Corresponding Applicant - University of Birmingham
KRISHNARAJAH NIRANTHARAKUMAR - Collaborator - University of Birmingham
Punith Kempegowda - Collaborator - University of Birmingham
Rasiah Thayakaran - Collaborator - University of BirminghamOutcomes:
- Primary outcomes: Length of hospitalisation; 30-day all-cause readmission rate; 30-day all-cause mortality rate; 1-year all-cause mortality rate.
- Secondary outcomes: 1-year cause-specific mortality; renal impairment; large vessel thromboses (stroke, myocardial infarction); cardiomyopathy; pulmonary oedema; gastrointestinal bleeding within 30 days of admission.Description: Lay Summary
People with very high blood sugar can sometimes get very sick. Two serious problems that can happen are diabetic ketoacidosis (DKA) and hyperosmolar hyperglycaemic state (HHS).
Technical Summary
DKA happens when the body doesnât have enough insulin, which is a hormone that helps sugar enter cells for energy. Without insulin, the body starts using fat for energy, which creates harmful chemicals called ketones. Too many ketones can make the blood too acidic, making a person very ill.
HHS mostly happens in people with type 2 diabetes when their blood sugar gets extremely high over time. This can cause severe dehydration, confusion, and weakness.
Both conditions are very dangerous and can lead to a coma or even death if not treated quickly.
Our study looks at how many people in the UK have had these emergencies and what happens to them afterward. We will check health records from 2001 to 2023 to see if certain peopleâlike those of a particular age, gender, ethnicity, income level, or locationâget these problems more often than others.
We also want to see what happens to people after they recover from DKA or HHS. Do they return to the hospital more often? Do they stay in the hospital longer? How does their health change over time?
By figuring out who is most at risk and why, we hope to find ways to help people get better care and avoid serious problems in the future.This study aims to describe inequities in the incidence and clinical outcomes of hyperglycaemic outcomes, specifically diabetic ketoacidosis (DKA) and hyperosmolar hyperglycaemic state (HHS), in the UK using linked health data from the Medicines and Healthcare Products Regulatory Agency (MHRA) Clinical Practice Research Datalink (CPRD), including primary care records linked to Hospital Episode Statistics (HES). The study period spans from January 1, 2001, to December 31, 2023. The population of interest includes individuals with type 1 and type 2 diabetes, with DKA and HHS cases identified using ICD-10 codes. In addition to hyperglycaemic events (DKA and HHS), this study will consider hypoglycaemic episodes. This expansion will enable a more comprehensive evaluation of glycaemic control outcomes among diabetic populations.
Objective 1.1: We will perform yearly cohort studies to calculate the crude incidence rate (IR) of DKA and HHS, examining variations by region, age, sex, ethnicity, socioeconomic status, and mental health conditions. The incidence rate will be calculated as the number of new DKA and HHS cases per 100,000 person-years at risk.
Objective 1.2: We will conduct a matched retrospective cohort study to investigate long-term clinical outcomes of DKA and HHS patients compared to matched controls without these conditions. Outcomes will include hospital length of stay, 30-day readmission rates, mortality rates, and episodes of hypoglycaemia during hospitalisation. Key covariates such as BMI, smoking status, and comorbidities will be adjusted for in the analysis.
Cox regression models will be used to calculate hazard ratios (HRs) for the outcomes, and stratified analyses will be performed to assess differences across population subgroups. This study aims to identify key groups at risk and inform future interventions to improve care and outcomes for hyperglycaemic events.
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Understanding the impact of common co-morbidities on non-idiopathic pulmonary fibrosis interstitial lung disease: A population-based study — Jennifer Quint ...
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Understanding the impact of common co-morbidities on non-idiopathic pulmonary fibrosis interstitial lung disease: A population-based study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-29
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Peter George - Collaborator - Royal Brompton Hospital
Thomas Gill - Collaborator - Imperial College London
Vidya Navaratnam - Collaborator - Imperial College LondonOutcomes:
Descriptive analysis:
Prevalence of common comorbidities (including but not limited to cardiovascular disease, chronic obstructive pulmonary disease, asthma, diabetes, gastro-oesophageal reflux disease, lung cancer, anxiety and depression) in people with non-IPF ILD
Prevalence of common comorbidities (as above) in people with IPF
Patterns of the prescribing of commonly-used medications for these conditions (including but not limited to antihypertensives, inhaled bronchodilators, oral corticosteroids, statins, proton pump inhibitors (PPIs), antidiabetic drugs including metformin)Outcome measures:
Hospitalisation (all cause, respiratory-related)
Mortality (all-cause, ILD-specific)Description: Lay Summary
Interstitial Lung Disease (ILD) is a group of chronic lung diseases characterised by inflammation and scarring of the lungs. Most people with an ILD complain of difficulty breathing, cough, tiredness and unexplained weight loss. In around half of cases, the underlying cause of the ILD is unknown; this then is called idiopathic pulmonary fibrosis (IPF). However, ILD can also be triggered by medical conditions such as rheumatoid arthritis, by environmental exposures (e.g. asbestos, bird feathers/droppings) or by certain medications; these forms of ILD are collectively referred to as non-IPF ILDs.
People with IPF â the most serious form of ILD â often also have other illnesses such as heart disease, diabetes and acid-reflux. People who have IPF and one or more other condition are more likely to be admitted to hospital and to die earlier compared with people who just have IPF. However, we do not know if the same is true of people with other, non-IPF types of ILD.
By using routinely-collected health information from GP records, hospital records and death certificates, we will determine how common the illnesses mentioned above are in people with non-IPF ILD. We will also determine if the presence of these illnesses influences the likelihood of being admitted to hospital and early death in the same way as it does in people with IPF. This study will help us understand how common medical conditions affect people with all types of ILD so that we can improve holistic care to this group of patients.
Technical SummaryInterstitial Lung Disease (ILD) describes a group of chronic lung diseases characterised by changes in the lung interstitium, which occur either due to an unknown cause or as a response to external triggers (e.g. occupational exposure, autoimmune disease). The most common type of ILD is idiopathic pulmonary fibrosis (IPF) and most published data relate to this group of people. Survival is poor, generally just 3-5 years following diagnosis. Reported estimates of the incidence and prevalence of non-IPF ILDs vary widely, but there is consensus that both are increasing worldwide. Data on the prognosis of people with non-IPF ILDs are more limited, but survival rates can be equally poor.
The prevalence of comorbidities such as cardiovascular disease, diabetes, gastro-oesophageal reflux disease (GORD), lung cancer, anxiety and depression in people with IPF is reasonably well documented, as is the impact of these comorbidities on survival. In contrast, large-scale epidemiological studies assessing the frequency of these common comorbidities in the non-IPF ILD patient population and how their presence impacts health-care utilization (e.g. hospitalization) and mortality are lacking.
Using CPRD Aurum-HES Admitted Patient Care linked data and a cohort study design, we will determine the prevalence of comorbidities in people newly-diagnosed with IPF or non-IPF ILDs between 1/1/2005 and 31/12/2022. We will also describe prescribing patterns of medications routinely used to treat these comorbidities, and categorise patients according to their comorbidity polypharmacy score (CPS). Multivariate Cox regression models will be employed to explore the association between each comorbidity and the risk of a) hospitalization, b) all-cause mortality and c) ILD-specific mortality. Regression models will also explore associations between the number of comorbidities, polypharmacy (>5 prescriptions) and the CPS score and all-cause mortality.
This study will have public health benefits with regards to improving care pathways and providing holistic care to this group of patients.
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Evaluate bias in body mass index and weight recording in the Clinical Practice Research Datalink Aurum — Rebecca Persson ...
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Evaluate bias in body mass index and weight recording in the Clinical Practice Research Datalink Aurum
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-28
Organisations:
Rebecca Persson - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Ellen Chang - Collaborator - Amgen Inc
George Kafatos - Collaborator - Amgen Ltd
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Obesity; type 2 diabetes; hypertension; dyslipidaemia; chronic kidney disease; obstructive sleep apnea; heart failure; metabolic dysfunction-associated steatohepatitis; osteoarthritis; myocardial infarction; ischemic stroke; coronary revascularization; peripheral arterial disease; motor vehicle accident
Description: Lay Summary
CPRD databases are especially important for studies of weight and body mass index (BMI) because this type of information is not captured in most medical databases. However, not all patients in the CPRD have weight measurements in their records. It is possible that patients with records containing two or more weight measurements over time which are needed to calculate a change in weight, may be different from patients whose records contain no or only one weight measurement. If patients are different (by age, socioeconomic status, health status, frequency of going to the general practitioner (GP), etc.) then when researchers select a group of patients to study those who have 2 or more weight measurements, the results of the study may be incorrect when applied to all patients. This is a type of bias. The goal of this study is to compare patient characteristics, health status, and health care utilization by the amount of weight information captured in CPRD Aurum to determine if this bias is present. The second goal is to evaluate whether researchers can adjust their study results/analysis to minimize the effect of this bias (if present). This study will benefit patients by providing patients and their clinicians information on potential bias present in studies of weight change. The results will also inform future CPRD Aurum study methods that are important to public health.
Technical SummaryCPRD databases are used to conduct observational studies that include information on longitudinal weight change. However, not all patients in CPRD databases have longitudinal weight/body mass index (BMI) recordings. Currently, we do not know how or if patient characteristics and risk factors differ based on the number of weight/BMI measurements recorded. Consequently, we also do not know what, if any, bias might be introduced by selecting patients with longitudinal weight/BMI measures for study inclusion.
The objective of this study is to describe patients in CPRD Aurum according to number of weight/BMI recordings, to assess how differences in recording frequency might introduce bias in population selection and results, in studies of weight change. We will use CPRD Aurum and linked Hospital Episode Statistics Admitted Patient Care (HES APC) to select a random sample of ~600,000 adult patients in years 2015 - 2022 without conditions associated with weight change in their record (e.g., cancer, amputation). In order to assess the presence of bias, we will compare patients by the presence and frequency of weight/BMI measures in CPRD Aurum with respect to patient characteristics (including Index of Multiple Deprivation) [n (%)], health care utilization [median (interquartile range)], and prevalence [n (%)] and incidence rates [IR (95% confidence interval, CI)] of obesity-related conditions recorded in CPRD Aurum and/or HES APC. We will calculate Inverse Probability of âRecordingâ Weights for the probability that a patient has at least two weight/BMI measures and estimate raw and weighted IRs (95% CI) of obesity-related outcomes. These weighted IRs will be compared to the IRs in the entire study population.
This study will benefit the UK population by providing patients and their clinicians information on potential bias present in studies of weight change. The results will also inform future CPRD Aurum study methods related to important public health topics.
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Exploring potential misclassification bias in ascertainment of disease diagnosis in electronic health records due to COVID-19 restrictions — Yun "Angel" Wong ...
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Exploring potential misclassification bias in ascertainment of disease diagnosis in electronic health records due to COVID-19 restrictions
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-01
Organisations:
Yun "Angel" Wong - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jonathan Bartlett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Luisa Pettigrew - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Marleen Bokern - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Qing Wen - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
First ever diagnosis of atrial fibrillation, coronary heart disease, heart failure, hypertension, peripheral arterial disease, stroke/transient ischaemic attack, diabetes mellitus, chronic obstructive pulmonary disease, dementia, rheumatoid arthritis, epilepsy, schizophrenia, other psychoses, and bipolar affective disorder, depression, asthma, cancer (breast, prostate, bowel, lung, and melanoma), chronic kidney disease, fractures, gastroenteritis, urinary tract infections, and retinal detachment.
Examine the trends of (1) GP consultation rates and (2) clinical measurements rates - recorded blood pressure measurements, HbA1c, and serum creatinine tests using 1 million randomly selected cohort.
Description: Lay Summary
Studies using electronic health records (EHRs) are used to improve healthcare in England and Wales. However, the recording of diagnoses in EHRs was reduced during COVID-19 pandemic. Any impact of reduction in diagnoses on health research is largely unclear. In this study, we will therefore explore possible reasons that could affect whether diseases were diagnosed and recorded during pandemic restrictions. By understanding the reasons, our study will improve methodology of future clinical studies to benefit patients in England and Wales. We will use routinely collected EHR data from primary care and hospitals to illustrate the trend of key health outcomes and primary care consultation rates (by types of consultation and clinicians delivering consultations) and clinical measurement rates before and after pandemic restrictions from 1/1/2017-31/3/2023. We will also explore whether the patterns of these specific diseases are different in different groups of people including people of different ages, men and women, different ethnicities, different levels of deprivation, at different risk of COVID-19 for shielding and between people living in different regions in England. We will finally explore likely measurement error mechanisms in ascertainment of outcomes using the trends of key health outcomes and primary care consultation rates.
Technical SummaryThe impact of pandemic healthcare disruption on estimating causal effects due to misclassification bias of outcomes is largely unclear. Analyses of outcomes may lead to biased estimates as the time to detect a disease could be delayed; or some diagnoses that would have been recorded were missed.
In this study, we will therefore explore possible reasons that could lead to the change in diagnostic recording, general practice (GP) consultation rates, or clinical measurement rates due to pandemic restrictions. We will use data from Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics (HES) and Office for National Statistics (ONS) respectively to illustrate the trend of 22 key health outcomes using the proportions of monthly outcomes from 1/1/2017 to 31/3/2023. We chose 22 different types of key health outcomes that could help inform how nature of diseases and recording patterns of diseases affect the changes. Further, we will report the trend of rates of GP consultation, and clinical measurements in a 1 million random sample that helps understand the role of complexities of diagnosis and healthcare seeking behaviours. We will conduct interrupted time series by modelling the proportion of outcomes within the populations defined in previously each month using a binomial generalised linear model and weight each monthâs data by the population size; with interruptions defined as initiation of restrictions (23/3/2020); and 2) lifting of restrictions (24/2/2022). We will explore how patient characteristics affect the changes by stratifying the proportion of outcomes by: age, sex, ethnicity, region, deprivation, and COVID-19 shielding. We will then use these trends to understand the reasons of missed/delayed ascertainment of different types of outcomes in different patient groups which could inform how to improve methodology of future studies to benefit patients in England and Wales.
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Maternal anaemia during pregnancy and other risk factors for congenital heart disease in offspring: a cohort study using the Clinical Practice Research Datalink (CPRD) Aurum database — Margaret Smith ...
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Maternal anaemia during pregnancy and other risk factors for congenital heart disease in offspring: a cohort study using the Clinical Practice Research Datalink (CPRD) Aurum database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Margaret Smith - Chief Investigator - University of Oxford
Cynthia Wright Drakesmith - Corresponding Applicant - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Duncan Sparrow - Collaborator - University of Oxford
Innocent Erone - Collaborator - University of Oxford
Manisha Nair - Collaborator - University of OxfordOutcomes:
Primary Outcome: Congenital heart disease (CHD) in live born children, including atrial and ventricular septal defects; atrioventricular septal defect; patent ductus arteriosus; tetralogy of Fallot; right- and left outflow tract obstruction; aortic and pulmonary valve defects; Ebsteinâs anomaly; transposition of the great arteries; common arterial trunk; and aortic arch anomalies.
Secondary Outcomes: CHD-specific infant mortality up to age 5 years; pregnancies resulting in stillbirth, miscarriage or late termination.Description: Lay Summary
Congenital heart disease (CHD) is a general term for any heart defect in newborn babies caused by something going wrong as the babyâs heart forms in the womb. It is the commonest type of birth defect, affecting 1 in 100 babies worldwide, with around 13 affected babies born each day in the United Kingdom. Untreated, more than half of them will die. Around one-third of cases are due to genes passed down from the parents. Other causes include the mother having diabetes, or taking certain medicines whilst pregnant. Our studies in animals suggest that anaemia in early pregnancy may be another cause. Anaemia happens when a person is low in haemoglobin, a protein that carries oxygen in the blood. Our recent study using Clinical Practice Research Datalink GOLD (22_001836) found that when mothers have anaemia in early pregnancy the chance of CHD in the child is 1.47 times higher than if the mothers donât have anaemia. In this study we will use Aurum to look at how anaemia or low iron in early pregnancy increases CHD risk in the offspring, compared to not having anaemia. Aurum is a bigger database so we can look in more detail at the link between low haemoglobin or low iron and CHD and at whether there is a link with CHD-specific infant mortality, still birth, miscarriage or termination of pregnancy. Our results may suggest whether women of childbearing age may need to supplement their diets with iron prior to pregnancy to avoid anaemia.
Technical SummaryWe aim to investigate the associations between maternal anaemia and iron deficiency during early pregnancy with congenital heart disease (CHD) in offspring. The research could benefit patients as peri-conceptional iron supplementation could be a low-cost intervention to prevent some cases of CHD, including in children with Downâs Syndrome.
Aim 1) investigates the associations between: maternal first trimester anaemia and iron deficiency and (i) CHD in offspring; (ii) CHD-specific infant mortality or stillbirth/miscarriage/pregnancy termination. Aim 2) investigates associations of these risk factors with CHD within the sub-population of offspring with Downâs Syndrome. Aim 3) is hypothesis generating, exploring relationships between other pre-defined maternal risk factors and offspring CHD.
The cohort for Aim 1) will include women with a haemoglobin value within the first 100 days of pregnancy (pregnancy register), and a live birth that can be linked to offspring primary care records (mother-baby link). We will include all pregnancies during 1998-2023. Exposures will be continuous haemoglobin or ferritin concentration, categories of maternal anaemia or iron deficiency (using WHO-recommended thresholds), and maternal anaemia defined from diagnostic codes. The primary outcome will be CHD in the offspring diagnosed before age 5 years (from primary care or linked HES admissions data or ONS mortality data). For secondary outcomes the cohort will also include mothers with live birth, stillbirth, miscarriage, or late termination (pregnancy register). For Aim 2) the cohort will be as Aim 1) but restricted to offspring with Downâs Syndrome. To increase cohort size, the cohort for Aim 3) will include all mother baby pairs whether or not there is a maternal haemoglobin value.
We will use multivariable Cox regression to investigate the association of CHD in live-born offspring with maternal risk factors, and multivariable logistic regression to investigate other outcomes. Confounders adjusted for will include IMD (linked data) ethnicity (CPRD derived data).
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Deprescription of antiplatelets in patients with stable peripheral artery disease anticoagulated for atrial fibrillation — Samy Suissa ...
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Deprescription of antiplatelets in patients with stable peripheral artery disease anticoagulated for atrial fibrillation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-15
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Antoine Pariente - Collaborator - University of Bordeaux
Christel Renoux - Collaborator - McGill University
Loubna DARI - Collaborator - McGill University
Sarah Beradid - Collaborator - Lady Davis Institute of the Jewish General HospitalOutcomes:
Primary effectiveness outcomes:
- Major limb event (MALE): hospitalisation for acute limb ischemia (ALI) or major amputation (above the ankle).
- Major cardiac event (MACE): composite of hospitalisation for myocardial infarction, ischemic stroke/transient ischemic attack, systemic embolism (SE) and cardiovascular death.Primary safety outcome: major bleeding defined as a composite of fatal bleeding and hospitalisation for bleeding.
Secondary outcomes:
- Broader MALE definition: hospitalisation for ALI, major or minor amputation (above or below the ankle), or lower limb revascularization.
- Net clinical benefit: composite of hospitalisation for MACE, MALE, fatal bleeding or hospitalisation for bleeding in a critical organ.Description: Lay Summary
Atrial fibrillation (AF) is a heart condition that increases the risk of stroke (brain clot). To reduce this risk, individuals with AF are prescribed blood-thinning medications called anticoagulants. Many individuals with AF can also present with peripheral artery disease (PAD), in which the leg arteries become narrowed or blocked, affecting blood flow to the legs. PAD can lead to amputations and increases the risk of stroke and heart attack. The main treatment for PAD is another type of blood-thinning medication called antiplatelets. It is unclear if patients with PAD and AF should receive both anticoagulants and antiplatelets or anticoagulants alone.
Technical Summary
Therefore, we will compare the safety and effectiveness of stopping treatment with antiplatelets in patients with PAD who already receive anticoagulation for AF. We will examine how frequently they experience leg problems such as amputations, stroke, heart attacks, and bleeding events compared with patients treated with antiplatelets and anticoagulants. This information will assist doctors in determining the best strategy for these patients. It could also lead to improved treatment recommendations for these leg artery issues and enhance the overall health of individuals coping with these conditions.Antiplatelets are the main treatment for PAD, but it is unclear if patients with PAD and AF should receive both anticoagulants and antiplatelets or anticoagulants alone. Thus, we will conduct a population-based cohort study to determine the effectiveness and safety of the deprescription of antiplatelets in patients newly treated with anticoagulants. This study will be conducted by linking the CPRD, the HES-inpatient and ONS-mortality databases. We will form a cohort of patients with AF and history of PAD between 01/2000 and 03/2023, and with concomitant prescription of antiplatelets and anticoagulants. We will use a prevalent new-user design with time-conditional propensity score matching to compare patients treated with anticoagulants for AF who stop antiplatelets and those who continue antiplatelets. All patients will be followed until one of the outcomes, death, treatment change, end of registration with the general practice, or end of the study period. The primary effectiveness outcomes will be major limb event (MALE) defined as a hospitalisation for an acute limb ischemia (ALI) or major amputation; major cardiac event (MACE) defined as a composite of hospitalisation for myocardial infarction, ischemic stroke, systemic embolism or cardiovascular death. The primary safety outcome will be major bleeding defined as a composite of fatal bleeding, hospitalisation for bleeding in a critical area/organ or any other hospitalisation for bleeding. We will use Cox proportional hazards models to estimate the hazard ratio and 95% confidence interval of each outcome associated with deprescription of antiplatelets compared with continuation of antiplatelets among patients using anticoagulants. Secondary analyses will include stratified analyses based on patientsâ characteristics, stage of PAD and anticoagulant dosage. Several sensitivity analyses will be performed to assess the robustness of our results.
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Time trends in prevalence, incidence, survival and characterisation of cancers in the United Kingdom 2000-2024 — Danielle Newby ...
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Time trends in prevalence, incidence, survival and characterisation of cancers in the United Kingdom 2000-2024
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-08
Organisations:
Danielle Newby - Chief Investigator - University of Oxford
Danielle Newby - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Elin Rowlands - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mayurikah Nadeshakumar - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Nuria Mercade Besora - Collaborator - University of Oxford
Rabia Khan - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of OxfordOutcomes:
Outcomes:Cancer diagnosis; mortality
Covariates: age; sex; comorbidities; medications
Description: Lay Summary
Cancer is one of the leading causes of illness and death worldwide, and the number of people affected by it is increasing. This is due to a combination of factors, including an aging population and changes in lifestyle and environment that influence cancer risk. To improve cancer care and prevention, it is important to track how often different types of cancer occur, how survival rates change over time, and what factors might influence these trends. This study will analyze medical records from Clinical Practice Research Datalink (CPRD) GOLD from adults (18 years and older) in the United Kingdom (UK) between 2000 and 2024. We will focus on many different cancers, including common ones like breast, lung, and prostate cancer, as well as rarer cancers such as those affecting the head and neck. We will examine how many people develop cancer, how long they live after diagnosis, and whether factors like age, sex, or health conditions (such as diabetes or obesity) influence these outcomes. We will also look at the medical history and medications of cancer patients before, during, and after their diagnosis. By comparing cancer patients to people without cancer, we can understand possible early warning signs and risk factors that could improve early detection and prevention. The results of this research will help doctors, policymakers, and scientists develop better strategies for cancer prevention, treatment, and care in the UK. The results will also compared to results from other countries across the globe to support international efforts in cancer care.
Technical SummaryBACKGROUND: Cancer is currently a leading cause of morbidity and mortality worldwide. The burden of cancer incidence and mortality is rapidly growing worldwide, reflecting both aging and growth of the populations as well as changes in the prevalence and distribution of the main risk factors for cancer. The continuous surveillance and monitoring of trends in cancer incidence and survival are needed for the development, implementation and evaluation of health policies aiming to reduce the burden of disease in the UK.
STUDY DESIGN: Cohort study
POPULATION: All people in aged 18 + years CPRD GOLD between 2000 and 2024 with at least 365 days of data availability.
CANCERS OF INTEREST: Bladder, brain, breast, cervix, colorectal, corpus uteri, esophagus, gallbladder, hodgkin's lymphoma, hypopharynx, kaposi's sarcoma, kidney, larynx, leukemia, lip/oral, liver, lung, melanoma skin, mesothelioma, multiple myeloma, nasopharynx, non hodgkin's lymphoma, non melanoma skin, oropharynx, ovary, pancreatic, penis, prostate, salivary gland, stomach, testis, thyroid, vagina, vulva.
ANALYTICAL METHODS
1) Estimation of annual period prevalence, annual incidence rates and overall survival (death by any cause) of cancer in those aged 18 years and older stratified by diagnosis year, age group, sex and cancer risk factors (e.g. type 2 diabetes, obesity). Denominator will be persons aged 18 and over years between 2000 and 2024.
2) Characterisation of cancer patients for each site, including medical history and co-medication use before, on and after cancer diagnosis stratified by age, related risk factors, and sex. Characteristics of cancer patients will also be compared to age and sex matched controls.The results from this study will primarily enhance understanding of cancer trends in the UK but will also contribute to a multinational, multi-database study across the globe, providing valuable insights into cancer patterns globally and supporting international efforts to improve prevention and treatment.
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Evaluating the incidence of systemic autoimmune rheumatic diseases in the Clinical Practice Research Datalink and mortality rates in people with these diseases diagnose — Anita McGrogan ...
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Evaluating the incidence of systemic autoimmune rheumatic diseases in the Clinical Practice Research Datalink and mortality rates in people with these diseases diagnose
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-29
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Anita McGrogan - Corresponding Applicant - University of Bath
Rachel Charlton - Collaborator - University of Bath
Sarah Tansley - Collaborator - University of BathOutcomes:
Primary outcomes: Incidence of systemic lupus erythematosus; systemic sclerosis; ANCA vasculitis, Giant cell arteritis/large vessel vasculitis, Sjogrenâs syndrome; other SARD/CTDs such as Mixed connective tissue disease; Undifferentiated connective tissue disease; eosinophilic fasciits; pansclerotic morphea.
Secondary outcomes: Standardised mortality rates by disease and calendar year; 5 year survival; seasonality of diagnosis.
(Serious outcome = mortality).Description: Lay Summary
Connective tissue diseases can occur when the human immune system behaves abnormally and attacks a personâs own body. This results in inflammation and ultimately damage to organs in the body including major organs (such as lungs, heart, kidneys) as well as joints and skin. People who suffer from these diseases need urgent treatment in order to prevent damage to their organs, reduce disability and even prevent death. Many are rarer diseases, and as such the exact cause is not fully understood. For many of the diseases, we understand that there is likely to be a gene that predisposes the person to developing this condition. Something in the environment then acts as a trigger for the disease to occur. Doctors who treat these conditions, often notice an increase in the number of people with a new diagnosis at different times of year, which is thought to be due to seasonal viruses or other substances in the environment. We would like to use the CPRD data to look at the incidence of these rare connective tissue diseases and how they are changing over time. The work will benefit patients through a greater understanding of disease occurrence over time and survival.
Technical SummaryThis cohort study will evaluate the incidence of systemic lupus erythematosus, systemic sclerosis, ANCA associated vasculitis, giant cell arteritis, Sjogrenâs syndrome, mixed connective tissue disease, undifferentiated CTD, eosinophilic fasciitis and pansclerotic morphea in the CPRD from 1/1/2000 to 31/12/2024 in people aged 18 years and older. Validation of diagnoses will include identifying relevant symptoms, prescribing, test results and referrals to rheumatology. Incidence will be reported by age band, sex and calendar year where numbers are sufficient to allow this breakdown of data. Patients being diagnosed with these diseases will be described by their characteristics, comorbidities, prescribing received and any serious outcomes that occur within a year of diagnosis will also be described. It has been reported previously that peaks of diagnoses for some diseases may follow peaks in flu occurrence therefore any trends of diagnoses will be explored by evaluating monthly incidence using Poisson generalised additive regression models. Mortality rates standardised to the European Standard Population will be determined to enable comparability with mortality rates from other studies and countries; 5 year survival will also be determined by disease type, where possible.
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Effect of hormone therapy for menopause on stroke among individuals with migraine with aura — Susan Jick ...
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Effect of hormone therapy for menopause on stroke among individuals with migraine with aura
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-29
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Liza Gibbs - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Ischemic stroke; hemorrhagic stroke; any non-traumatic stroke
Description: Lay Summary
Migraine is a common condition that affects many women, often starting in early adulthood. People with a specific type of migraine called âmigraine with auraâ can experience things like flashing lights in their vision or a tingling feeling in addition to having a migraine headache. People with migraine with aura have higher chances of having a stroke. When women reach menopause, they may use hormone therapy to help with symptoms like hot flashes. Hormone therapy is usually safe, but doctors are sometimes cautious about giving it to women with migraine with aura because the risk of stroke is not well understood. Our study will look at whether hormone therapy for menopause affects the chance of having a stroke for women with migraine with aura. To do this, we will follow women aged 40 and older diagnosed with migraine with aura who start hormone therapy and compare them to similar women who do not use hormone therapy. This research will help patients and doctors in the United Kingdom make more informed choices about hormone therapy for menopause.
Technical SummaryOver 40% of women will experience migraine of any type over their lifetime, with a median age of onset of 25 years. Migraine with aura affects approximately one third of migraineurs and is associated with a two-fold increased risk of ischemic stroke compared to non-migrainous status. Migraine with aura is not a contraindication for hormone therapy for menopause, though some treatment guidelines recommend caution in prescribing in this population due to increased risk of stroke observed with higher-strength estrogen-containing medications such as oral contraceptives. However, the risk of stroke associated with use of hormone therapy has not been studied among migraineurs with aura specifically. This study aims to estimate the effect of initiating hormone therapy for menopause compared with never initiating hormone therapy for menopause on the risk of stroke among migraineurs with aura. Stroke will be ascertained using both Aurum and HES APC data to ensure complete case capture. This study will follow user female users of hormone therapy and matched non-users ages 40 years and older with a prescription or matched date between January 2000 and September 2024. The risk of stroke associated with hormone therapy use versus non-use will be compared, with inverse probability of treatment and censoring weighting to account for baseline and time-varying confounding and differential loss to follow-up. The risk of stroke will be compared via risk difference using linear regression in the primary analysis, and risk ratios via log-binomial regression and hazard ratios using Cox proportional hazards regression in secondary analyses. 95% confidence intervals for risk differences, risk ratios, and hazard ratios will be calculated via non-parametric bootstrap. This research will use causal epidemiologic methods to provide patients and clinicians with higher quality information about risk of stroke associated with hormone therapy for menopause among migraineurs with aura to inform clinical decision making.
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Menopause and hormone replacement therapy use in patients with systemic lupus erythematosus — Anita McGrogan ...
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Menopause and hormone replacement therapy use in patients with systemic lupus erythematosus
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-05-23
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Anita McGrogan - Corresponding Applicant - University of Bath
Christine MacFadyen - Collaborator - University of Bath
Rachel Charlton - Collaborator - University of BathOutcomes:
Primary outcomes: prevalence of menopause and perimenopause, prescribing and duration of use of hormone replacement therapy, trends in prescribing of hormone replacement therapy over time, osteoporosis, cardiovascular events (myocardial infarction, coronary artery bypass, acute coronary syndrome, stroke, transient ischaemic attack), venous thromboembolism, breast cancer, ovarian cancer, endometrial cancer.
Description: Lay Summary
The menopause and perimenopause are known to cause severe symptoms in some women and have a significant impact on quality of life. Some symptoms can be improved with hormone replacement therapy (HRT). Use of HRT may lower the risk of osteoporosis but some types of HRT may increase the risk of blood clots and stroke.
Systemic lupus erythematosus (also known as lupus) is a medical condition which mostly affects women and commonly occurs prior to the menopause. Lupus can be associated with an increased risk of blood clots. Lupus patients are more likely to go through the menopause earlier than patients without lupus and have a higher risk of osteoporosis. There is a lack of understanding of how menopause affects women with lupus, how it is managed and whether HRT has an impact on risks of other health problems.
Current guidelines recommend use of HRT in certain circumstances. This study plans to help us understand how frequently lupus patients see their doctor about menopause symptoms, whether they are prescribed HRT, other medications or given a specialist referral. We would also like to find out whether they are more or less likely to suffer with problems such as osteoporosis and blood clots if they are given HRT compared to menopausal lupus patients not on HRT and women without lupus.This information will help us understand how lupus patients are currently treated and find areas where more research is needed to give better advice about managing menopausal symptoms in lupus patients.
Technical SummaryThe menopause and peri-menopause can cause a variety of symptoms and have a significant impact on quality of life. Hormone replacement therapy (HRT) has been shown to alleviate symptoms, improve quality of life and can have positive effects on bone health. Some forms of HRT are associated with a higher risk of thrombo-embolic disease. Lupus affects more women than men and is typically diagnosed before menopause. Evidence is limited about menopause or HRT in women with lupus. This study will provide valuable evidence for patients and healthcare providers about how to manage symptoms of the menopause in women with lupus.
This study will describe the occurrence of menopause and perimenopause, as recorded in the Clinical Practice Research Datalink in women with lupus and in a group of women matched on age and GP practice who do not have lupus. Women aged 40-50 years at study entry date will be included and the study period will be from 1/1/2004-31/12/2024. Patient characteristics will be compared by age when menopause or perimenopause is recorded, body-mass-index, smoking, comorbidities and coprescribing. Prescribing of HRT will be described in terms of rates of use, duration of treatment, type of HRT prescribed and changes over 5-year time periods will be evaluated. Prescribing of non-hormonal therapies that might be used in place of HRT will be described. These include gabapentin, pregabalin, clonidine, paroxetine, fluoxetine, citalopram, escitalopram, sertraline and venlafaxine.
The incidence of osteoporosis, cardiovascular events, thromboembolic events, breast, ovarian and endometrial cancers will be found, comparing women with lupus and women who do not have lupus. Where the sample size is sufficient, each outcome will be evaluated using logistic regression adjusting for confounders and determining if there is an association with the outcome and HRT prescribing for women with lupus and women who do not have lupus.
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ID-464: Networked Data Lab: Topic 6 – Exploring the impact of living with damp & mould / in fuel poverty on adverse health outcomes, healthcare resource usage and costs across NWL — Imperial College Health Partners...
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ID-464: Networked Data Lab: Topic 6 – Exploring the impact of living with damp & mould / in fuel poverty on adverse health outcomes, healthcare resource usage and costs across NWL
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Damp & Mould. Commercial
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ID-462: Preventing in-hospital harm to people with diabetes through a data-driven virtual ward round intervention — Imperial College London...
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ID-462: Preventing in-hospital harm to people with diabetes through a data-driven virtual ward round intervention
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: diabetes.
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ID-216-6: Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London. — Imperial College London...
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ID-216-6: Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: multimorbidity in depression. Commercial
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ID-435-2: Fine-tuning and Validating a Type 1 Diabetes Risk Prediction Algorithm — Stanhope Mews Surgery...
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ID-435-2: Fine-tuning and Validating a Type 1 Diabetes Risk Prediction Algorithm
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Stanhope Mews Surgery
Description: Diabetes. Commercial
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ID-463: Understanding and Controlling Hospital-Acquired Influenza Through Network Modelling — Imperial College London...
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ID-463: Understanding and Controlling Hospital-Acquired Influenza Through Network Modelling
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Influenza.
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ID-300-5: Extension: Cluster analysis of patients with pre-metabolic and metabolic syndrome to determine their association with pathological outcomes, to aid the generation of pre-emptive therapeutic targeting utilising artificial intelligence — Imperial College Healthcare NHS Trust/Imperial College London...
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ID-300-5: Extension: Cluster analysis of patients with pre-metabolic and metabolic syndrome to determine their association with pathological outcomes, to aid the generation of pre-emptive therapeutic targeting utilising artificial intelligence
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/Imperial College London
Description: Metabolic Syndrome. Commercial
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ID-430-1: Extension: Changing Futures JSNA — Westminster City Council...
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ID-430-1: Extension: Changing Futures JSNA
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: missing.
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ID-465: Heat Wave Impact Report — Westminster City Council...
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ID-465: Heat Wave Impact Report
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Heat Wave.
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ID-429-1: Extension: Combating Substance Misuse — Westminster City Council...
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ID-429-1: Extension: Combating Substance Misuse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Substance misuse.
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ID-271-5: Polypharmacy — Imperial College London...
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ID-271-5: Polypharmacy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Polypharmacy.
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ID-466: Inclusiveness of NWL data recording — Imperial College London...
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ID-466: Inclusiveness of NWL data recording
Legal basis:research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: data recording.
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ID-374-3: PREPARE: Evaluation of the Electronic Palliative Care Coordination Systems to support advance care planning for people living with life-limiting conditions — Royal Marsden NHS Foundation Trust...
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ID-374-3: PREPARE: Evaluation of the Electronic Palliative Care Coordination Systems to support advance care planning for people living with life-limiting conditions
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Royal Marsden NHS Foundation Trust
Description: Palliative care coordination systems.
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ID-259-5: Extension: JSNA Program (CHECK) — Westminster City Council...
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ID-259-5: Extension: JSNA Program (CHECK)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: JSNA.
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ID-461: Hounslow Enhanced Dementia Care Service (EDCS) – Service Evaluation and Analysis — West London NHS Trust...
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ID-461: Hounslow Enhanced Dementia Care Service (EDCS) – Service Evaluation and Analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-25
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Dementia.
Source
2025 - 04
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Examining ethnic and deprivation inequalities in multiple long-term conditions (MLTC) or multimorbidity burden and their relationship to clinical outcomes in people with diabetes — Salwa Zghebi ...
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Examining ethnic and deprivation inequalities in multiple long-term conditions (MLTC) or multimorbidity burden and their relationship to clinical outcomes in people with diabetes
Datasets:GP data, 1) Annual and overall prevalence of multiple long-term conditions (MLTC) as overall and by age, gender, ethnic groups and deprivation levels; and, annual and overall prevalence of polypharmacy (5 or more prescriptions).
2) 1, 3, 5-year diabetes-related and all-cause hospitalisation risks associated with MLTC burden.
3) 1, 3, 5-year diabetes-related and all-cause mortality risks associated with MLTC burden.
4) The associated economic costs relating to differences in hospital activity
5) Years of life lost by age at diabetes and MLTCs diagnosis.Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-22
Organisations:
Salwa Zghebi - Chief Investigator - University of Manchester
Rosa Parisi - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Alyaa Ajabnoor - Collaborator - University of Manchester
Christos Grigoroglou - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Kamlesh Khunti - Collaborator - University of Leicester
Luke Munford - Collaborator - University of Manchester
Mamas Mamas - Collaborator - University of Keele
Martin Rutter - Collaborator - University of Manchester
Naresh Kanumilli - Collaborator - NHS England
Naveed Sattar - Collaborator - University of Glasgow
Qianyu Liu - Collaborator - University of Manchester
Steven Scholfield - Collaborator - University of ManchesterOutcomes:
1) Annual and overall prevalence of multiple long-term conditions (MLTC) as overall and by age, gender, ethnic groups and deprivation levels; and, annual and overall prevalence of polypharmacy (5 or more prescriptions).
2) 1, 3, 5-year diabetes-related and all-cause hospitalisation risks associated with MLTC burden.
3) 1, 3, 5-year diabetes-related and all-cause mortality risks associated with MLTC burden.
4) The associated economic costs relating to differences in hospital activity
5) Years of life lost by age at diabetes and MLTCs diagnosis.Description: Lay Summary
Diabetes (high blood sugar) affects 5 million people in the United Kingdom costing £1 per £10 of healthcare spending. People with diabetes are more likely to be admitted to hospital or die prematurely than people without diabetes. Previous studies showed that 3 in 4 people with diabetes have one or more other health conditions.
When the same person has two or more health conditions, this is known as multiple long-term conditions (MLTC) or multimorbidity. People with MLTC often take multiple medications, visit their doctor or are admitted to hospitals more often. Previous research showed that people with diabetes from some ethnic groups (e.g. Black or Asian people) or those who live in deprived areas are more likely to have MLTC, including mental illness, than White people or those living in more affluent areas. But, whether this is true for people with diabetes is unknown.
We will use anonymised electronic health record data of people with diabetes and MLTC in general practices in England to determine the number of health conditions people have and if these numbers are higher or lower by peopleâs ethnic groups (e.g. White, Black, Asian) and level of socio-economic deprivation (living in deprived or affluent areas). We will also determine if people with more health conditions are more likely to be hospitalised or die prematurely.
Our results are expected to provide important information on trends of MLTC in England in people with diabetes by ethnic group and by deprivation level, which will help to plan healthcare needs.
Technical SummaryBackground
The UK prevalence of diabetes is increasing rapidly and currently affects 5 million people, costing the NHS £10bn annually. People with diabetes face avoidable and systematic differences in health care, which disproportionately affect people from some ethnic groups or deprived populations (health inequalities). The main forms of diabetes are type 1 (T1DM) and type 2 (T2DM), accounting for approximately 10% and ~90% of all diabetes, respectively. Over 30% of people with T1DM and 75% of people with T2DM have at least one other long-term condition known as multiple long-term conditions (MLTC). MLTC is often linked to polypharmacy and adverse outcomes, including hospitalisation. Previous studies examined MLTC mainly by deprivation or ethnicity, but some were based on small populations.Aims/objectives
1) Examine MLTC burden and diabetes-related and all-cause hospitalisation and mortality trends in people with diabetes as overall and by ethnic and/or deprivation categories; 2) Examine the association between ethnicity-specific and deprivation-specific MLTC, their intersectionality with outcomes and costs relating to differences in hospital activity.Methods
Using a population-based cohort study of people with diabetes and MLTC between 2010-2023, we will examine overall and annual trends of MLTC using descriptive statistics (MLTC counts, prevalence), latent class analysis, and multi-state models. Cox proportional hazard models and competing risk regression models will be used to estimate the association between MLTC and diabetes-specific and all-cause mortality and hospitalisation outcomes at 1, 3, and 5 years. We will explore diabetes as overall (both types) and analysed separately for people with T1DM and T2DM and by age groups. Further, we will determine the associated costs relating to differences in hospital activity.With increasing prevalence of diabetes and ageing population living with MLTC, our findings and linkages to hospitalisation, deprivation/ethnicity data can inform clinicians and future guidelines to address potential inequalities in diabetes and MLTC care.
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The Use of Incretin-Based Drugs and Sodium-Glucose Co-Transporter-2 Inhibitors for the Prevention of Parkinson's Disease Among Patients with Type 2 Diabetes — Samy Suissa ...
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The Use of Incretin-Based Drugs and Sodium-Glucose Co-Transporter-2 Inhibitors for the Prevention of Parkinson's Disease Among Patients with Type 2 Diabetes
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-03
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Ninh Khuong - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sarah Beradid - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
We will identify all patients with a first diagnosis of PD. PD will be identified using Read codes and SNOMED Clinical Terms (listed in appendix 1).
Description: Lay Summary
Patients with type 2 diabetes (high blood sugar) have an increased risk of developing Parkinson disease, a disabling brain disease . However, it is uncertain whether lowering blood sugar can help prevent Parkinson disease in patients with diabetes. Some newer blood sugar lowering medications are of particular interest because they not only decrease blood sugar levels but may also have a direct effect on the brain and provide additional protection against Parkinson disease. Thus, we will evaluate whether individuals who are treated with these newer medications have a lower risk of Parkinson disease compared with individuals who are treated with an older, more common antidiabetic drug but without any effect on the brain. To perform this study, we will use the CRPD with medical information from millions of patients. We will then select patients with diabetes treated with the older medication and compare them to patients treated with the newer medications to determine whether those treated with the newer medications are less diagnosed with Parkinson disease. The proposed research project will provide information on the potential benefit of the newer blood sugar lowering medications in preventing Parkinson disease. If we show that these drugs are beneficial, this study will provide important information to inform prescription choices in the management of individuals with type 2 diabetes and could improve the future health outcomes of these patients.
Technical SummaryType 2 diabetes is associated with an increased risk of Parkinson disease (PD). There is emerging evidence that glucagon like peptide-1 receptor agonists (GLP-1RAs), dipeptidyl peptidase-4 inhibitors (DPP-4Is), and sodium-glucose co-transporter-2 inhibitors (SGLT-2Is), commonly used second-line antihyperglycemic drugs, may have neuroprotective effects. Small trials showed encouraging results on motor function in patients with PD. Sulfonylureas, another second-line drug, do not seem to have these properties. The primary objective is to assess separately whether GLP-1RAs, DPP-4Is, and SGLT-2Is, compared with sulfonylureas, are associated with a decreased risk of PD among patients with type 2 diabetes. We will conduct a cohort study using the CPRD database. We will assemble three new-user, active comparator cohorts among patients with type 2 diabetes at least 50 years of age. The first and second cohorts will compare initiators of GLP-1RAs and DPP-4Is, respectively, with initiators of sulfonylureas from 2007 (the year incretin-based drugs entered the market) until 2021. The third cohort will compare initiators of SGLT-2Is with initiators of sulfonylureas from 2013 (the year SGLT-2Is entered the market) until 2021. Cox proportional hazards models will be fit to estimate hazard ratios and 95% confidence intervals of PD associated with these three drugs compared with sulfonylureas. Clarifying the neuroprotective effect of these drugs would optimize their use in patients with type 2 diabetes.
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Addressing ethniC inequaliTies In healthcare use and quality amONg people with painful Diabetic Neuropathy (ACTION-DN) — Nicola Adderley ...
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Addressing ethniC inequaliTies In healthcare use and quality amONg people with painful Diabetic Neuropathy (ACTION-DN)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-24
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Zhaonan Wang - Corresponding Applicant - University of Birmingham
KRISHNARAJAH NIRANTHARAKUMAR - Collaborator - University of BirminghamOutcomes:
Objective 1, yearly prevalence: painful diabetic peripheral neuropathy (PDPN) patients in the database on 1st January each year will be counted.
Objective 2, annual incidence: new (incident) PDPN cases each year (1st January-31st December) will be counted.
Objective 3, cohort study: outcome will be the development of incident PDPN during the study period.
Objective 4, symptoms: presenting symptoms will be described by ethnic group.
Objective 5, management: pharmacological treatments, pain management, opioid use/abuse, spinal cord neuromodulation will be described by ethnic group.
Objective 6, outcomes cohort study: all-cause mortality; suicide; amputation, depression, anxiety, primary care consultations, referrals, hospital admissions.Description: Lay Summary
High blood sugar which is called diabetes is increasingly common and can lead to a painful condition called painful diabetic peripheral neuropathy (PDPN), affecting 1/4 people with diabetes. This nerve damage, which causes severe pain in the feet, legs, and hands, significantly impacts patients' daily activities. Ethnic minority populations, including South Asian and African-Caribbean communities, face a higher risk of both diabetes and chronic pain, yet the impact and quality of care for PDPN in these groups are poorly understood. Crucially, there is a lack of epidemiological data including prevalence and incidence by ethnic group. Addressing this is crucial as these communities often experience worse healthcare services.
Our goal is to develop a better understanding the effect of PDPN among ethnic groups on the burden of disease to reduce ethnic inequalities in PDPN.
We will improve our understanding of ethnic differences in PDPN by:
Technical Summary
1. Describing the percentage of people with a diagnosis of PDPN by ethnic groups and region, and by looking at how this has changed from 2010 - 2023.
2. Describing the number of new cases of PDPN each year, from 2010 to 2023, by ethnic group and regions.
3. Exploring risk factors related to development of PDPN among people with diabetes, including ethnicity.
4. Exploring differences in symptom presentation by ethnic group.
5. Exploring pain medications prescribed for PDPN and describing whether this varies among ethnic groups.
6. Exploring the association between ethnic disparities and death, suicide rate and other important outcomes among patients with PDPN.Painful diabetic peripheral neuropathy (PDPN) is a debilitating diabetes complication which leads to poor quality of life. South Asian and African-Caribbean individuals may face a higher risk of PDPN than White individuals considering higher risk of T2DM and chronic pain in these groups, and this disparity exacerbates healthcare-related inequalities. Better understanding the scope and causes of these disparities will support healthcare practitioners to address them and improve patient outcomes.
Objectives:
1. Calculate yearly PDPN prevalence 2010-2023, by region and ethnicity among patients with diabetes.
2. Calculate annual PDPN incidence 2010-2023, by region and ethnicity among patients with diabetes.
3. Explore risk factors associated with PDPN among patients with diabetes.
4. Among PDPN patients, describe symptoms related to PDPN by ethnic group.
5. Describe pharmacological treatment inertia, psychological pain management, opioid use/abuse, spinal cord neuromodulation in PDPN patients by ethnic group.
6. Among PDPN patients , explore mortality, suicide rates, amputation, depression, anxiety, primary care consultations, referrals, and hospitalisation by ethnic group.Population:
Patients with a diagnosis of type 1 or type 2 diabetes, aged â¥18 years registered at a GP contributing to CPRD Aurum; additionally for Objectives 4-6:patients with diagnosis of PDPN.Exposures and outcomes:
Objective 3: risk factors: sociodemographic (age, sex, Index of Multiple Deprivation [IMD], ethnic group), comorbidities (mental health conditions, alcohol use disorder, smoking history, neurological, pain-related conditions), metabolic/diabetes-related factors (obesity, hypertension, dyslipidaemia, retinopathy, nephropathy, cardiovascular disease); outcome: PDPN
Objective 6: exposure: ethnic minority groups, comparator: white ethnicity; outcome: all-cause mortality, suicide, amputation, depression, anxiety, primary care consultations, referrals, hospitalisation.Study design, analysis:
1. Prevalence: yearly cross-sectional analyses.
2. Incidence: annual cohort studies.
3. Cohort study: Cox regression model to calculate unadjusted/adjusted hazard ratios (HRs)
4. Descriptive statistics for symptoms.
5. Descriptive statistics for treatment/management.
6. Cohort study: Cox model to calculate unadjusted/adjusted HRs for each outcome.
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Effect of combined oral contraceptives on stroke among individuals with migraine with aura — Susan Jick ...
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Effect of combined oral contraceptives on stroke among individuals with migraine with aura
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-04
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Liza Gibbs - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Ischemic stroke; hemorrhagic stroke; any non-traumatic stroke
Description: Lay Summary
Migraine is a common condition that affects many women, often starting in early adulthood. People with a specific type of migraine called âmigraine with auraâ can experience things like flashing lights in their vision or a tingling feeling in addition to having a migraine headache. People with migraine with aura have higher chances of having a stroke. Because of this, doctors usually advise people with this type of migraine not to take birth control pills that contain estrogen. This advice is based on older studies that looked at pills with higher amounts of estrogen than are used today. Some experts now believe we need more research to understand whether todayâs birth control pills carry the same level of risk. Our study will look at whether using birth control pills with estrogen increases the risk of stroke in people with migraine with aura compared to those who take a different type of birth control that does not contain estrogen. This research will help doctors and patients in the United Kingdom make more informed choices about birth control options.
Technical SummaryOver 40% of women will experience migraine of any type over their lifetime, with a median age of onset of 25 years. Migraine with aura affects approximately one third of migraineurs and is associated with a two-fold increased risk of ischemic stroke compared to non-migrainous status. Estrogen-containing combined oral contraceptives are contraindicated in those with a history of migraine with aura due to stroke risk based on older studies of higher-dose formulations, but experts more recently have called for additional research more reflective of the lower doses prescribed today. This study aims to estimate the effect of initiating combined oral contraceptives compared to non-estrogen containing oral contraceptives on the risk of stroke among individuals with migraine with aura. This study will follow a new-user, active comparator cohort of patients ages 15-49 years prescribed combined oral contraceptives versus progestogen-only pills between January 2000 and September 2024. The risk of stroke associated with combined oral contraceptives versus progestogen-only pills will be compared, with inverse probability of treatment and censoring weights used to account for baseline and time-varying confounding as well as differential loss to follow-up. The risk of stroke be compared via risk difference using linear regression in the primary analysis. Secondary analyses will estimate risk ratios via log-binomial regression and hazard ratios using Cox proportional hazards regression. 95% confidence intervals will be calculated via non-parametric bootstrap and will be reported for risk differences, risk ratios, and hazard ratios. This research aims to use causal epidemiologic methods to provide patients and clinicians with higher quality information about the risk of stroke associated with use of modern-day combined oral contraceptives to inform clinical decision making.
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Transitions in dementia and biomarkers trajectories in the UK population (TraDBiT) — Subhashisa Swain ...
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Transitions in dementia and biomarkers trajectories in the UK population (TraDBiT)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-11
Organisations:
Subhashisa Swain - Chief Investigator - University of Oxford
Subhashisa Swain - Corresponding Applicant - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
kirti Tanwar - Collaborator - University of Oxford
Klaus EBMEIER - Collaborator - University of Oxford
Rafael Perera - Collaborator - University of OxfordOutcomes:
We aim to have three outcomes from this project-
1- understanding the transition of people across different stages in dementia progression and the factors associated with these transitions in primary care
2- understanding the trajectory of the biomarkers and prediction of dementia, hospitalisation, and death in different MLTCs clusters
3- to cluster people and the biomarkers based on the diagnosis, hospitalisation, and death in dementiaDescription: Lay Summary
Nearly a million people in the UK live with dementia. Caring for those with dementia is a growing problem in health and social care. Living with dementia can lead to a poor quality of life and worse general health outcomes.
Technical Summary
People with dementia initially often show memory loss or forgetfulness during the initial consultation with their primary care physician. There is a gap in time from when memory loss is reported to a confirmed diagnosis of dementia. We are trying to understand how this progression into a dementia diagnosis happens in different people and if this depends on their sex, age group, ethnicity, and the presence of other long-term conditions. We will also examine how some of the available routinely requested tests (like sugar levels in blood or blood pressure) are related to progression to dementia and death.
Understanding the journey of the person towards dementia and the associated factors can help to detect the stage where appropriate intervention can be taken to reverse or slow the process. Exploring the changes of different routinely collected information on factors such as blood pressure and blood sugar level may assist in predicting a diagnosis of dementia much earlier without relying on expensive tests. We will also use advanced statistical methods to group people based on clinical outcomes such as death and hospital admission.
To answer this, we will use one of the UKâs largest primary care records datasets.Background
With increased years of living, an increased prevalence of dementia and multiple long-term conditions (MLTCs) is reported. Dementia is a complex condition with multisystemic consequences and the management of dementia becomes more complex in the presence of MLTCs. According to NHS England, in the UK, nearly 850,000 people live with dementia, and almost 80% of people with dementia have MLTCs.
Studying the life course epidemiology of risk factors with existing pathophysiological (1) process would enable a better understanding of the progressive cognitive and functional decline in dementia in later life. New discussions are underway to include established biomarkers, such as amyloid proteins in combination with the clinical criteria (2) for diagnosis of pre-clinical dementia(3). Often, these biomarkers are tested only when an individual is suspected of having dementia and are not available in primary care. We are interested in seeing if the biomarkers available in primary care, such as ESR, CRP, SBP, DBP, etc., show any changes during the trajectory until dementia diagnosis.
The expected trajectory is that a healthy person first undergoes a mild cognitive impairment (MCI) stage before a dementia diagnosis and, finally, an outcome of death. However, it is not understood the rate of transition from one state to another in the UK primary care population and how factors such as ethnicity, multimorbidity, consultations, referrals, and socioeconomic status influence these transitions.
Detecting abnormalities and transitions using routinely collected biomarkers for dementia can be helpful for early prediction and taking early preventive measures.
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Evaluating the impact of the national roll out of TARGET (Treat Antibiotic Responsibly; Guidance, Education and Tools) toolkit and training on antibiotic prescribing: a quasi-experimental study — Donna Lecky ...
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Evaluating the impact of the national roll out of TARGET (Treat Antibiotic Responsibly; Guidance, Education and Tools) toolkit and training on antibiotic prescribing: a quasi-experimental study
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-29
Organisations:
Donna Lecky - Chief Investigator - UK Health Security Agency (UKHSA)
Ming Xuan Lee - Corresponding Applicant - UK Health Security Agency (UKHSA)
Jade Meadows - Collaborator - UK Health Security Agency (UKHSA)
Nina Zhu - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
Primary Outcomes: Whether antibiotic was prescribed for each of the infection consultations identified (urinary tract infection and respiratory tract infection), agent type and duration prescribed, prescribing rates as total number of antibiotic items per 1,000 GP consultations, resource used in consultation (dissemination of patient leaflet).
Secondary Outcomes: General practice (GP) re-consultation rates; GP re-prescribing rates as proxy to indicate potential failure of first line treatment.
Description: Lay Summary
TARGET (Treat Antibiotic Responsibly; Guidance, Education and Tools) toolkit is a resource aiming to support appropriate antibiotic prescribing in primary care setting. Training on the toolkit was rolled out nationally in October 2022 following evidence suggesting that training on TARGET significantly reduced antibiotic prescribing. As this is the first national implementation of the training, it is important to evaluate the processes and the impact of the training.
We will look at what helped and did not help when rolling out the training. The study will also assess the impact of training on the use of TARGET resources during general practice (GP) appointments and antibiotic prescribing. This is achieved using anonymous data from GP appointments for respiratory and urinary tract infections from January 2016 to March 2025. We will compare these antibiotic prescriptions against the recommended treatment. We will also study whether antibiotic prescribing differ in different areas and populations. We will also look at whether patients revisit the GP or if they get prescribed more antibiotics. We will add our findings together with data collected from interviews with people who prescribe antibiotics.
The findings will show whether it was easy to roll out the training and whether it made a difference to the amount and type of antibiotics prescribed. This will help us see how we can improve the roll out of TARGET training in the future and tell us whether increasing TARGET training can help reduce the total antibiotic use in human populations by 5% from the 2019 baseline.
Technical SummaryA rigorous randomise-controlled evaluation in general practice (GP) showed that a one-hour TARGET (Treat Antibiotic Responsibly; Guidance, Education and Tools) workshop combined with demonstrating the resources, significantly reduced antibiotic prescribing. This resulted in the national roll of the TARGET training. Using a mixed-methods design, we propose to investigate (a) the process of the national roll out of TARGET training including barriers and facilitators of training uptake at a local level, (b) estimate the impact of training on the utilisation of TARGET resources in GP, and on antibiotic prescribing (e.g. prescribing volume, prescribing rates, adherence to national guidelines).
Using data from various sources, including CPRD Gold and Aurum, we will look at GP consultations for respiratory and urinary tract infections from January 2016 to March 2025 to assess the uptake of TARGET leaflets, measure the antibiotics prescribed of each infection and their types (lower/upper), compare the duration and type of antibiotics prescribed against national guidelines. We will use interrupted time-series analysis to detect changes in prescribing volumes for each region and GP practices. Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)-adjusted prescribing volumes will be compared across regions, including those who have and have not rolled out TARGET training. We will also compare regions with different socioeconomic levels using the index of multiple deprivation to evaluate antibiotic prescribing. Secondary outcomes will include assessing GP re-consultation and re-prescribing. The qualitative aspect of the process evaluation will use the Consolidated Framework for Implementation Research (CIFR) as a guide for analysis.
Findings of this research will inform the future of the TARGET training roll out and the development and implementation of future interventions. Specifically, this evaluation will provide an indicator of whether scaling up the training can facilitate the reduction of total antibiotic use in human populations by 5% from the 2019 baseline.
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Type and timing of menopausal hormone therapy use in relation to risk of breast cancer, ovarian cancer, and endometrial cancer. — TienYu Owen Yang ...
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Type and timing of menopausal hormone therapy use in relation to risk of breast cancer, ovarian cancer, and endometrial cancer.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-09
Organisations:
TienYu Owen Yang - Chief Investigator - University of Oxford
TienYu Owen Yang - Corresponding Applicant - University of Oxford
Gillian Reeves - Collaborator - University of Oxford
Kirstin Pirie - Collaborator - University of OxfordOutcomes:
New diagnosis of breast cancer, ovarian cancer, and endometrial cancer.
Description: Lay Summary
The use of hormone therapy for menopausal symptoms is known to increase the risk of breast cancer, with risks varying by the type of hormone used. However, further evidence is needed on the role of more contemporary forms of hormone therapy in breast cancer incidence. Hormone therapy for menopause also alters the risks of ovarian and endometrial cancer, and evidence on the associations of these cancers with currently used preparations is also required.
We will use CPRD Aurum to explore common and emerging patterns of hormone therapy use for menopause in the UK, categorized by type, dose, and delivery mode (eg. oral or gel). We will then investigate the association between different use patterns and the risks of breast, ovarian, and endometrial cancers by comparing the number of cancer cases among individuals who have used different hormone therapy patterns, accounting for factors such as age, body size, and concurrent medical conditions.
Technical SummaryUse of menopausal hormone therapy (MHT) is known to increase the risk of breast cancer, and this increased risk is greater for use of combined as opposed to oestrogen-only preparations. Most of the existing evidence is based on MHT preparations that were in common use prior to 2015. Further evidence about the role of more contemporary MHT preparations is needed. MHT use is also known to alter the risks of ovarian and endometrial cancer, and so evidence on the effects of contemporary preparations on these cancers is also needed.
In this study, we will use CPRD Aurum to describe the common and emerging patterns of MHT use in the UK women population (age 30 years or older) and to investigate the association between different MHT use patterns and risk of breast cancer, ovarian cancer, and endometrial cancer.
Information on MHT use will be extracted from CPRD Aurum to describe how the prevalence of use of different types of HRT, based on regimen, hormonal constituents, doses, and delivery mode, varies over calendar period. A nested case-control study will then be conducted for each cancer site to investigate the association between various patterns of MHT use and cancer risks. During the follow-up of CPRD Aurum, cancer cases recorded in CPRD Aurum, hospital admission records, and death registries, will be matched to appropriate controls. Where appropriate, relative risks of cancer will be compared by patterns of MHT use using conditional logistic regression, adjusted for potential confounding factors available in the CPRD Aurum.
Findings from this study will provide the necessary information to address research questions highlighted in the recent NICE guidelines [NG23 in 2024] regarding cancer risks associated with contemporary forms of MHT, many of which include different forms of progestogen to those that were widely used in the UK prior to 2015.
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Examining the benefits and harms of antihypertensive and statin treatment: A prognostic modelling study — James Sheppard ...
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Examining the benefits and harms of antihypertensive and statin treatment: A prognostic modelling study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-22
Organisations:
James Sheppard - Chief Investigator - University of Oxford
James Sheppard - Corresponding Applicant - University of Oxford
Ariel Wang - Collaborator - University of Oxford
Richard McManus - Collaborator - Brighton and Sussex Medical School
Richard Stevens - Collaborator - University of OxfordOutcomes:
Primary outcome â Cardiovascular disease
Description: Lay Summary
People are living for longer, with more long-term health conditions. One example is high blood pressure, where people can take 3-4 drugs to prevent stroke. However, dozens of people have to be treated for at least a year to prevent a stroke in one person. This is because these drugs only reduce the possibility of stroke, they do not remove it altogether. Some of these patients may be prone to side effects such as falls and kidney problems which may be more common in some people than any benefits.
Technical Summary
This proposal aims to use information from the medical records from millions of patients to understand who might be more likely to experience a stroke or heart attack. Using this information, we will then explore how commonly prescribed drugs used to treat blood pressure and cholesterol reduce this risk. We will also use existing information we have to examine how likely these drugs are to increase the risk of side effects in the same patients. This information will be used to develop a decision aid that will help patients and doctors make better informed decisions about starting or continuing drugs used to treat blood pressure and cholesterol.Background
The population is ageing and consequently, the number of people living with age-related chronic conditions is increasing. Polypharmacy (five or more prescribed medications) is common in older people and is associated with an increased risk of adverse drug reactions. Preventative medications, such as those used to manage blood pressure, are common in polypharmacy and often require large numbers of people to be treated to prevent a small number of cardiovascular disease (CVD) events. This leaves many individuals on drugs of little benefit, some of whom may be susceptible to side effects such as falls and kidney problems.Aims
This proposal aims to develop a prediction model for cardiovascular disease, using the same data, and methods as previous models developed for the harms of antihypertensive treatment, and use these to model the benefits and harms of antihypertensive treatment across the population.Methods
Aim 1: Derive a prognostic model for an individualâs risk of cardiovascular disease, taking into account the competing risk of death, using linked data from CPRD GOLD (including data from primary care, HES admitted patient care, ONS death registry and patient level IMD).
Aim 2: Externally validate this model using linked data from CPRD Aurum (including data from primary care, HES admitted patient care, ONS death registry and patient level IMD).
Aim 3: Combine baseline risk estimates from this model, and those previously developed models predicting adverse events from treatment with treatment effect estimates from the literature to model the benefits and harms of antihypertensive statin treatment.The findings of this work will be used to support GPs, pharmacists and patients in making evidence-based decisions about prescribing for cardiovascular disease prevention. It is anticipated that more evidence-based prescribing will lead better prevention of cardiovascular disease and fewer adverse drug events in England and Wales.
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Identifying disparities in prescribing of SGLT2- inhibitors in people with Chronic Kidney Disease — Tim Jones ...
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Identifying disparities in prescribing of SGLT2- inhibitors in people with Chronic Kidney Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-03
Organisations:
Tim Jones - Chief Investigator - University of Bristol
Dominic Taylor - Corresponding Applicant - North Bristol NHS Trust
- Collaborator -
Fergus Caskey - Collaborator - University of Bristol
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes:
Prescription of SGLT2 inhibitor drugs.
Discontinuation of SGLT2 inhibitor drugs amongst those who received them.Description: Lay Summary
Aims
To establish whether newly-available, prescribed tablets called 'Sodium-GLucose Transporter 2 inhibitors' (shortened to 'SGLT2 inhibitors') - are prescribed equally for everyone with kidney disease who could benefit from them.Background
SGLT2 inhibitor tablets are recommended treatments for people with:
1) diabetes
2) heart failure
3) kidney disease with high urine protein levelsWhen taken by people with these conditions, these tablets are proven to improve health, however, other research shows that these are not prescribed for everyone who could benefit from them.
People who live in areas of the country with higher deprivation (with lower income, employment, education, and poorer housing) are less likely to be prescribed the best treatments. People with kidney diseases can also be less likely to receive best treatment for their other medical conditions. Differences in treatment by gender have also been found previously.
Methods
We will analyse English general practice (GP) and hospital data on prescriptions of SGLT2 inhibitors for people with kidney disease who have:
a) diabetes
b) heart failure
c) high urine protein levelsWe will compare SGLT2 inhibitor prescriptions between men and women, people of different ethnicities, and age groups, and areas with different levels of deprivation.
We will compare prescribing between people with diabetes or heart failure with and without kidney disease.We will establish which groups of people are more and less likely to receive these tablets. This will help us and others to design the best ways of getting these treatments to the people who need them.
Technical SummarySGLT2 inhibitors (SGLT2is) reduce mortality and morbidity in people with type 2 diabetes mellitus(T2D), heart failure(HF) and proteinuric chronic kidney disease (CKD), so are recommended by NICE for these conditions.(1-4) However, people with CKD are less likely to receive recommended care for associated diseases.(5) Further, inequities in access to healthcare have been repeatedly demonstrated within the CKD population, by socioeconomic status, gender, age, and ethnicity.(6) These inequities are likely to affect SGLT2i prescriptions, but this has not been described in a contemporary, representative population such as CPRD Aurum.
In this analysis of CPRD Aurum, we will compare rates of SGLT2i prescription:
1) for Type 2 diabetes (T2D) or Heart Failure (HF) between those with vs without CKD
2) for any licenced indication (T2D, HF, or CKD) by sociodemographic and clinical characteristicsWe will identify CKD cases from CPRD laboratory results and diagnosis codes. We will describe SGLT2i prescription rates for people with CKD, T2D, or HF. For people with T2D or HF, we will describe SGLT2i prescription rates for people with and without CKD. Within the CKD population we will describe SGLT2i prescription rates by sociodemographic and clinical factors.
We will use a retrospective cohort design to determine the impact of CKD (primary exposure), sociodemographics (sex, age, ethnicity, derived frailty score, deprivation score) and clinical factors (CKD stage, cardiovascular/metabolic comorbidities, mental health disorders, learning disabilities) on SGLT2i prescription rates in England to treat T2D, HF and CKD. We will establish predictors of discontinuation which may exacerbate inequity in treatment benefit, and examine equitable access stratified by cardiovascular risk (QRISK3) to determine numbers need to treat for benefit. Analysis requires record-linkage to HES-APC, ONS Death Registration and Patient-level IMD.
Kidney Research UK have commissioned this work to understand disparities in SGLT2i prescribing and inform future service redesign work to optimise care.
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Examining the Association between Ethnicity, Socioeconomic Status and the Initiation of Cardiorenal Protective Medication in Eligible Type 2 Diabetes Mellitus Patients. — Nicola Adderley ...
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Examining the Association between Ethnicity, Socioeconomic Status and the Initiation of Cardiorenal Protective Medication in Eligible Type 2 Diabetes Mellitus Patients.
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-09
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Sukainah Alfaraj - Corresponding Applicant - University of Birmingham
Andreas Karwath - Collaborator - University of Birmingham
Shamil Haroon - Collaborator - University of BirminghamOutcomes:
Prescription of SGLT2i/GLP-1A among T2DM patients and time to treatment initiation, defined as the duration from eligibility to the first prescription of an SGLT-2i/ GLP1-A.
Description: Lay Summary
We are conducting a study to explore when people with type 2 diabetes (T2DM) start taking medications that protect their kidneys and hearts. These medications can prevent serious complications. We want to understand how a personâs socioeconomic status and ethnic background might influence the timing of when these medications are prescribed.
Technical Summary
People from ethnic minority groups and those with lower incomes often experience more severe diabetes complications, like heart or kidney problems, compared to others. However, these groups also face more challenges in accessing healthcare. For example, a type of medication called SGLT2i (Sodium-Glucose Co-Transporter-2 inhibitors) and GLP-1A (glucagon-like peptide-1 receptor agonists) have been shown to provide significant benefits for heart and kidney health, but it is unclear whether everyone has equal access to them.
By studying a large group of adults with T2DM using health records from a GP healthcare database, we aim to find out whether these differences in access exist in UK. This will help healthcare policymakers and providers understand whether these highly effective medicines for type 2 diabetes are being provided equitably across the population.Aim:To investigate disparities in initiating SGLT2i and GLP-1A among adults with type 2 diabetes (T2DM), focusing on the influence of ethnicity and socioeconomic status (SES).
Objectives:Evaluate the initiation of SGLT2i and GLP-1A among T2DM patients with different ethnicity and SES.Study Population:Adults with T2DM included in the CPRD Aurum using diagnostic codes, who are eligible for SGLT2i or GLP-1A based on clinical guidelines. We will conduct the analysis in two separate cohorts:one consisting of individuals eligible to receive SGLT2i and another consisting of individuals eligible to receive GLP-1A. Within each cohort, we will compare individuals who received the respective medication to those who did not. Eligible individuals for SGLT2i therapy include those with a history of heart failure, established atherosclerotic cardiovascular disease such as coronary heart disease, prior myocardial infarction, cerebrovascular disease, or peripheral arterial disease, or those at high cardiovascular risk. High cardiovascular risk is defined as a QRISK2 score of â¥10% in adults aged â¥40, or an elevated lifetime cardiovascular risk in individuals <40 with one or more risk factors, including hypertension, dyslipidemia, smoking, obesity, or a family history of premature cardiovascular disease. Individuals eligible for GLP-1A therapy include those with a BMI â¥35 kg/m² and an HbA1c >48 mmol/mol, despite receiving triple therapy with metformin and two other oral antidiabetic agents.
Primary Exposure
Ethnicity and SES.
Outcome
The primary outcome is treatment initiation of SGLT2i or GLP-1A, defined as the first prescription recorded after eligibility criteria are met.Study Design
Retrospective cohort study.Methods
The analysis will be conducted in two separate cohorts. The first cohort will compare SGLT2i recipients to non-recipients, while the second cohort will compare GLP-1A recipients to non-recipients. We will use Cox proportional hazards regression to estimate crude and adjusted hazard ratios for disparities in treatment initiation timing, adjusting for potential confounders.
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Calcium pyrophosphate deposition disease epidemiology: risk factors and outcomes using data from the Clinical Practice Research Datalink. — Abhishek Abhishek ...
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Calcium pyrophosphate deposition disease epidemiology: risk factors and outcomes using data from the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-22
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Georgina Nakafero - Corresponding Applicant - University of Nottingham
Edoardo Cipolletta - Collaborator - University of Nottingham
Tristan Pascart - Collaborator - Universite Catholique de LilleOutcomes:
Study 1: Incidence and prevalence of CPPD disease:
⢠Primary-care record of CPPD disease.Study 2: Risk factors of acute CPP crystal arthritis.
⢠Common bacterial infections: primary-care consultation for urinary tract infection, lower respiratory tract infection, pneumonia hospitalisation.
⢠Vaccination against seasonal influenza, pneumococcal pneumonia, herpes zoster, and COVID-19.
⢠Drugs causing hypomagnesemia: loop diuretics, thiazides, proton pump inhibitorsStudy 3: Clinical outcomes of acute CPP crystal arthritis:
⢠Fatal and non-fatal Major Acute Cardiovascular Events.
⢠Other cardio-vascular outcomes: atrial fibrillation, congestive cardiac failure.Study 4: Outcomes of CPPD disease: dementia, frailty, osteoporotic fractures.
Description: Lay Summary
Calcium pyrophosphate deposition (CPPD) disease occurs when calcium crystals accumulate within the joints. Once released from their pre-formed deposits, the crystals cause severe arthritis. This manifests as rapid onset of pain, localized swelling, and inability to use the affected area. These flares last for a few days to weeks, and typically affect the knee, wrist, shoulder, elbow or ankle. CPPD disease can also manifest with persistent joint pain and inflammation. It mainly affects individuals over the age of 70. The epidemiology of CPPD disease in the English population has not been fully evaluated. The triggers of CPPD flare-ups are not well understood. Recently, it was reported that flares of gout were linked with a temporary increase in the risk of heart-attack and stroke. Whether acute flares of CPPD are associated with an increased risk of heart-attack, and stroke in the short-term is not known. Using the Clinical Practice Research Datalink (CPRD) Aurum, a high-quality database representative of the English population, we aim to determine how common CPPD disease is. We will investigate whether infection, injury, vaccination, and the use of some medicines is associated with an increased risk of CPPD flares. Additionally, we will examine whether these flares are linked to an increased risk of heart-attack and stroke. We will also find out whether CPPD disease is associated with frailty.
Technical SummaryObjectives:
[1]: To examine the incidence and prevalence of CPPD disease
[2]: To examine the risk factors of acute calcium pyrophosphate (CPP) crystal arthritis i.e., infections, vaccinations, and drugs that cause hypomagnesemia
[3]: To examine whether acute CPP crystal inflammatory arthritis is associated with major adverse cardiac and cerebrovascular events (MACEs).
[4] To examine whether CPPD disease is associated with frailty, dementia, osteoporotic fractures.Methods:
Data source: Clinical Practice Research Datalink (CPRD) Aurum. Incepted in 1987, with a linkage between primary and secondary care data since in 1997, it is a longitudinal anonymized electronic database containing health records of 50 million UK residents (of which 35 million are eligible for linkage), that is still ongoing. It contains details about diagnoses, prescriptions, immunizations, and is linked with hospitalization and mortality records through the Hospital Episode Statistics and the Office for National Statistics databases.
Population: Adults with at least one diagnostic coding of CPPD disease, i.e., âfamilial chondrocalcinosisâ, âchondrocalcinosisâ, âchondrocalcinosis due to pyrophosphate crystals of the kneeâ, and âpseudogoutâ.Study Design:
To answer objective [1], we will use a cohort study.
To answer objectives [2] and [3], we will perform a nested case-control study.
To answer objective [4], we will use a cohort study.Benefit from research: This study will help understand the population burden of CPPD disease. It will allow us to identify triggers of acute CPP crystal arthritis and thereby allow the development of preventive mechanisms. Similarly, a better understanding of short-term consequences of acute CPP crystal arthritis flare and long-term consequences of CPPD disease will promote initiatives to develop treatment modalities of this condition. Currently, there are no treatment modalities specifically developed for this condition. If CPPD disease was found to be associated with frailty, dementia and osteoporosis, it would allow screening and prevention interventions to be implemented.
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Feasibility study to examine the numbers of patients with records of mental health disorders by deprivation — Sheri Oduola ...
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Feasibility study to examine the numbers of patients with records of mental health disorders by deprivation
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-29
Organisations:
Sheri Oduola - Chief Investigator - University of East Anglia
Kathryn Richardson - Corresponding Applicant - University of East Anglia
Mizanur Khondoker - Collaborator - University of East AngliaOutcomes:
Depression; depression symptoms; anxiety; severe mental illness (SMI); mortality; self-harm/suicide; hospital admission; GP-led physical health check; blood pressure; Body Mass Index (BMI); alcohol consumption, lipid profile; glucose; smoking status; moving GP.
Description: Lay Summary
Mental health difficulties have been increasing for some groups of people since the COVID pandemic more than others, but there is uncertainty over which groups currently have the greatest mental health burdens. Studies suggest that there are also probable health inequalities in mental health outcomes in young people and adults in poorer communities compared with other parts of the country. Health inequities are often large, avoidable, and unjust differences in the experience of health and illness. They can have many different causes. To help us plan a large research grant application to address mental health inequalities, we first need to examine whether there are enough people experiencing mental health difficulties and the outcomes we are interested in within CPRD data. We are going to look in the CPRD Aurum database linked with hospital admissions data and deprivation data to see how many people aged between 11 and 64 years were diagnosed with either a common mental health problem or a severe mental health illness. We are interested in how many of these were later admitted to hospital, had an annual physical health check, experienced self-harm, or died . To help us understand how well we can address inequalities, we will also examine these counts by deprivation, age group, gender, ethnicity, and region. Ultimately the findings of our research will help the development of targeted interventions to address inequalities in mental health burdens and outcomes.
Technical SummaryTo assist planning a research grant application to address mental health inequalities, we aim to examine whether there are enough people coded with mental health difficulties and the outcomes of interest in CPRD linked data. We aim to use CPRD Aurum linked to Hospital Episode Statistics Admitted Patient Care (HES APC) and patient-level Index of Multiple Deprivation (IMD) to provide the following counts:
1) The number of patients with first record of (a) depression (b) depression or depression symptoms (c) anxiety (d) common mental disorders (depression, depression symptoms or anxiety) and (d) severe mental illness (SMI) in CPRD and/or HES APC during 2010-2025 occurring after 12 months GP registration.
2) The number of patients identified above with (a) common mental disorder (b) SMI, and
(i) a death record by 2025.
(ii) subsequent hospital admission (stratified by planned and unplanned admissions). The number of these admissions with (a) common mental disorders or (b) SMI noted during the admission.
(iii) subsequent record of self-harm/suicide.
(iv) subsequent record of a GP-led physical health check or records indicating a GP-led physical health check had been completed (i.e. blood pressure, BMI, alcohol consumption, lipid profile, glucose and smoking status records)3. The number of patients with a prior record of (a) common mental disorders and (b) psychotic disorders transferred out of the GP practice 2010-2025 and before death (i.e. moved GP).
We will report these counts separately by year, gender, ethnicity, region, age group, and patient-level IMD decile.
We will also summarise the number of subsequent hospital admissions and health checks using summary statistics such as mean, standard deviation, median, and interquartile range. We will not report cell counts <5.Ultimately the findings of our future research grant will help the development of targeted interventions to address inequalities in mental health burdens and outcomes.
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Inequalities in treatment receipt and time-to-treatment among patients diagnosed with breast, bowel, lung or prostate cancer: a matched cohort study — Robert Kerrison ...
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Inequalities in treatment receipt and time-to-treatment among patients diagnosed with breast, bowel, lung or prostate cancer: a matched cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-03
Organisations:
Robert Kerrison - Chief Investigator - University of Surrey
Robert Kerrison - Corresponding Applicant - University of Surrey
Elena Finn - Collaborator - Royal Marsden Hospital
Emma Giles - Collaborator - Teesside University
Eva Morris - Collaborator - University of Oxford
Gary Abel - Collaborator - University of Exeter
Katriina Whitaker - Collaborator - University of Surrey
Natalie Gil - Collaborator - University of Surrey
Tetyana Perchyk - Collaborator - University of SurreyOutcomes:
Treatment receipt. Treatment receipt will be binary and categorised as:
i. Surgery received (yes/no)
ii. Radiotherapy received (yes/no)
iii. Chemotherapy received (yes/no)
iv. Targeted therapy received (yes/no)
v. Immunotherapy received (yes/no)
vi. Hormone therapy received (yes/no)Time-to-treatment. Time-to-treatment will be continuous, and reported as:
i. Number of days to first surgical treatment
ii. Number of days to first radiotherapy treatment
iii. Number of days to first chemotherapy treatment/prescription
iv. Number of days to first targeted therapy treatment/prescription
v. Number of days to first immunotherapy treatment/prescription
vi. Number of days to first hormone therapy treatment/prescriptionDescription: Lay Summary
People from marginalised groups, such as ethnic minority groups, are more likely to die from cancer. One reason for this, is that, compared with other people, people from marginalised groups do not start cancer treatment as quickly, and are less likely to receive some treatments.
To date, researchers interested in cancer inequalities have focused largely on people from ethnic minority groups, people living in deprived areas, and people living with long term illnesses, such as diabetes. There has been little research for other marginalised groups, including people with learning disabilities, people with autism, people with severe mental illness, and people who are transgender. Understanding whether these marginalised groups similarly do not start treatment as quickly, or are less likely to receive specific treatments, would help us understand why they are more likely to die from cancer, and what the NHS can do to stop this from happening.
We will look at the medical records of people from 'under-researched groups' and compare them with the medical records of other people, to see whether they are similarly not receiving treatment as quickly, or whether they are less likely to receive some treatments, such as surgery, chemotherapy and radiotherapy. This will tell us where there are issues with treatment, for these groups, and what needs to be done, in order to give these patients the best chances for survival.
Technical SummaryCancer is a leading cause of mortality in the United Kingdom. Chances for survival are improved when patients receive treatment (âtreatment receiptâ), with further improvement when treatment is initiated early (shorter âtime-to-treatmentâ). Unfortunately, both are subject to inequalities, with people from marginalised groups being less likely to receive treatment / waiting longer to start treatment. The evidence for these inequalities, however, is limited, with little-to-no research conducted for many cancers, treatments and marginalised groups, including most groups outlined in NHS Englandâs national framework for reducing health inequalities.
The aim of this research, therefore, is to identify which marginalised groups are less likely to receive which treatments, or wait longer to start those treatments, in relation to which cancers.
The aims of the research will be addressed through a series of matched cohort studies. Each cohort study will focus on a different marginalised group. The marginalised groups of interest are:
ii. People from ethnic minority groups
iii. People experiencing deprivation
iv. People with comorbidities
v. People with learning disabilities (LDs)
vi. People with severe mental illness (SMI)
vii. Autistic people
viii. People who are Lesbian, Gay or Bisexual (LGB)
ix. People who are transgenderIndividuals from each of these groups will be matched (separately) on a 1:5 ratio (where possible) with cohorts, according to year of diagnosis, age at diagnosis, stage at diagnosis, cancer site, performance status and region.
Inequalities in treatment receipt, for each treatment, by cancer site, will be assessed using matched logistic regression. Inequalities in time-to-treatment, for each treatment, by cancer site, will be assessed using accelerated failure time models.
The dataset will comprise linked data from the Clinical Practice Research Datalink, the Cancer Registry and Hospital Episode Statistics. Individuals will be those diagnosed with breast, bowel, lung or prostate cancer, between January 2009 and December 2018.
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Assessment of the winter burden of asthma and chronic obstructive pulmonary disease after treatment review: An electronic healthcare record study. — Michael Hale ...
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Assessment of the winter burden of asthma and chronic obstructive pulmonary disease after treatment review: An electronic healthcare record study.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-07
Organisations:
Michael Hale - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Michael Watt - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
Asthma exacerbation; Chronic Obstructive Pulmonary Disease (COPD) exacerbation; healthcare resource utilisation; healthcare costs; patient characteristics influencing treatment reviews; hospitalisation; mortality; predictors of treatment reviews; risk factors contributing to asthma and COPD-related hospitalisations.
Description: Lay Summary
Asthma and chronic obstructive pulmonary disease (COPD) are long-term respiratory conditions affecting millions of people in the UK. They cause difficulty in breathing, cough, and wheeze, which can worsen and result in exacerbations (respiratory attacks), leading to hospitalisation and, in severe cases, death. In addition to the significant impact on patientâs health, asthma/COPD places a large burden on the National Health Service (NHS) accounting for significant healthcare costs.
In the STARBURST study, we will explore the association between disease control and exacerbations in patients with asthma or COPD during the winter months when the NHS is under the greatest pressure. COPD exacerbations tend to worsen in winter, and those for asthma remain high, though lower than the spring/autumn peaks.
Using the Clinical Practice Research Datalink (CPRD), the study will compare winter exacerbations, hospital admissions, and healthcare costs for asthma or COPD patients classified as having controlled disease, partly controlled disease or poorly controlled disease. In addition we will consider the same outcomes for those who had a previous treatment review and those who did not and investigate factors including treatment changes, timing of reviews, and disease severity to understand what works best for improving care and outcomes.
This will help create better strategies for managing asthma and COPD, particularly in preventing winter exacerbations, which has the potential to ease pressures on the NHS and enhance public health overall.
Technical SummaryRespiratory diseases are a major factor in winter pressures faced by the National Health Service (NHS). The STARBURST study aims to evaluate the impact of disease control and treatment reviews upon winter exacerbations and healthcare resource utilisation in patients with asthma or chronic obstructive pulmonary disease (COPD).
This retrospective cohort study will use data from the Clinical Practice Research Datalink (CPRD) Aurum database, linked with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) Death Registration and Index of Multiple Deprivation data. The study population will include adults with a diagnosis of asthma or COPD between 01/10/2012 and 30/09/2021, with at least 12 months continuous enrolment before the index date (01/10/2022). The study will focus on outcomes during the winter period (01/10/2022 to 31/03/2023). Patients will be categorised as controlled/partially controlled/non-controlled based on the baseline period (01/10/2021 to 30/09/2022) and patients who attended a treatment review in this period will also be compared to those without a review.The primary objective will be the incidence of exacerbations and healthcare resource utilisation and costs associated with disease control. Secondary outcomes will include the association between treatment reviews and exacerbations, treatment change and exacerbations and characteristics of patients undergoing treatment review. The exploratory objective is to compare mortality among patients with asthma or COPD for all patients and by selected subgroups.
Poisson/negative binomial regression models will be used to assess the association of prespecified covariates on the primary outcome. Cox proportional hazards models and Kaplan Meier curves will be used for time-to-event analyses, and ordinal logistic regression to assess factors associated with treatment review engagement. To quantify the impact of factors on engagement with treatment review and with subsequent exacerbations, prediction models will be created.
The findings will inform strategies to enhance asthma and COPD management.
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Comparison of patient characteristics when screened for their malnutrition risk or treated for malnutrition in primary care in England — Ailsa Welch ...
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Comparison of patient characteristics when screened for their malnutrition risk or treated for malnutrition in primary care in England
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-09
Organisations:
Ailsa Welch - Chief Investigator - University of East Anglia
Jane Skinner - Corresponding Applicant - University of East Anglia
Charlotte Davies - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East AngliaOutcomes:
Outcome
⢠MUST screening and score of 0 (low risk of malnutrition), 1 (medium risk), or 2 plus (high risk) or unknown score
o Annual prevalence and comparison of characteristics of screened and unscreened
⢠Prescription of ONS (Oral Nutritional Supplements)
o Annual prevalence and comparison of characteristics of prescribed and unprescribedSecondary outcome measures
⢠All-cause mortality (CPRD-defined)
⢠Number of hospital admissionsDescription: Lay Summary
Malnutrition is a common condition for older people in the United Kingdom (UK) that is often overlooked. It is strongly linked with conditions such as losing muscle, becoming frail, fractures and having more than one long-term health condition. Around one third of people over 65 years have malnutrition either in the community or in hospital. Malnutrition increases costs of health care and leads to longer hospital stays. The annual costs to clinical and social care systems are large, including malnutrition (£23 billion), sarcopenia (£2.5 billion), frailty (£5.8 billion), osteoporosis and fragility fractures (£4 billion). Finding solutions for malnutrition provides a significant opportunity for saving money and improving health outcomes for people and the National Health Service (NHS).
Technical Summary
Currently we have no recent estimates of the number of people screened for malnutrition in England or their characteristics. There are no current estimates of how malnutrition screening relates to hospital admissions or mortality.
Our study aims to find out how many people have been screened for malnutrition, or prescribed oral nutritional supplements, and to compare them with people who have not. We plan to use GP records in the UK to find the number of people who have been screened and what factors are linked to malnutrition. Based on our previous research, factors such as age, smoking habit, blood levels of vitamins, inflammation and medical conditions are different in people with malnutrition.
Our findings will inform future work on understanding the development of a potential new malnutrition screening tool.Malnutrition is an overlooked condition for older people in the UK and there are no recent estimates of the prevalence of nutrition screening or the associations of malnutrition with a range of demographic, health care or clinical biochemistry factors. This study aims to fill this gap in knowledge with a view to informing future development of a malnutrition screening tool.
We will report annual prevalence rates of MUST (Malnutrition Universal Screening Tool) screening and separately of a new course of Oral Nutritional Supplements (ONS) prescribing in CPRD patients over the age of 65 years from 2010 onwards. We will also estimate prevalence rates by gender, age group, IMD quintile, and recent registration. We will use Poisson regression adjusted for calendar year and weighted by the person-time of follow-up in each year to estimate confidence intervals. We will compare patient characteristics such as age, smoking, blood vitamins, inflammation and medical conditions between MUST categories and between those screened and unscreened controls using unconditional and conditional logistic regression respectively and similarly for those prescribed ONS compared to unprescribed controls. We will compare (i) mortality and (ii) hospital admission rates in the next year. We will report the mortality rate per 100 person-year follow-up for each MUST category and for the ONS prescribed. We will estimate hazard ratios (HRs) using Cox proportional hazards regression to compare mortality risk in each MUST category compared to the unscreened control group and similarly for ONS-prescribed patients and their controls. We will calculate incidence rate ratios (IRRs) for the number of hospital visits in the year of follow-up after the first MUST record in each MUST category compared to their unscreened control group using negative binomial regression and similarly for ONS-prescribed and their controls. We will report crude HRs and IRRs and those adjusted for potential confounders.
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Understanding inequalities in cancer diagnostic outcomes for people with Learning Disabilities — Luke Mounce ...
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Understanding inequalities in cancer diagnostic outcomes for people with Learning Disabilities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-04
Organisations:
Luke Mounce - Chief Investigator - University of Exeter
Bianca Wiering - Corresponding Applicant - University of Exeter
Gary Abel - Collaborator - University of ExeterOutcomes:
1. Primary care interval (days from first presentation (CPRD) to referral (HES)
2. Secondary care appointment interval (days between referral and specialist appointment (HES)
3. Secondary care diagnostic interval (days from specialist appointment to diagnosis (HES and NCRAS)
4. Diagnostic interval (days from first presentation as identified in CPRD to diagnosis (NCRAS))
5. The number of primary care consultations in the 24 months preceding diagnosis (CPRD).
6. Emergency route to diagnosis (NCRAS)
7. Primary care referral (a referral recorded in HES after a record of a cancer feature in CPRD)
8. Cancer-related investigations (CPRD and HES)
9. Post-diagnostic survival (ONS)Description: Lay Summary
Background: People with learning disabilities are not diagnosed with cancer as quickly as people without
learning disabilities. This means that by the time they are diagnosed their cancer is more advanced and
harder to treat. We do not have a lot of information about what happens when people with learning
disabilities have cancer-related symptoms, or what can support a timely diagnosis.Aim: This study is part of a bigger study combining different research methods to understand the cancer diagnostic process for patients with learning disabilities. We will analyse a large dataset drawing on patientâs general practitioner (GP), hospital and cancer records (with people's names removed). We will study what type of symptoms patients with a learning disability go to see their GP with, what type of investigations GPs do (for example, a blood test or scan), and whether patients are referred to hospital, and if so, which type of referral is used (for example, routine or urgent referral). This will help us understand where there are avoidable delays in the diagnosis of cancer for people with learning disabilities and whether there are symptoms of possible cancer patients with learning disability present with, that GPs do not know of.
Dissemination: The results of this study will help us understand why there are delays in diagnosing cancer in people with learning disabilities and make recommendations for how this could be improved. We will deliver a stakeholder event, summaries of our findings in accessible format, in addition to academic papers and conference presentations
Technical SummaryBackground: There are around 1.5 million people with learning disabilities (PwLD) in the UK. Cancer is the second most common cause of death, accounting for 15.7% of avoidable mortality. Our previous work suggests that PwLD experienced disadvantages in the cancer diagnostic process. We therefore aim to explore PwLDâs interactions with the health system in the cancer diagnostic process and highlight avoidable delays and inequalities.
Methods: We will use linked Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics (HES), and national cancer registry data. We will study two cohorts. The Case Cohort will include PwLD diagnosed with incident cancer between 2010 and the latest available registry data. They will be matched 1:5 to controls diagnosed with cancer, but without LD, and 1:5 to PwLD without cancer. We will use accelerated failure time models and consultation frequency analysis to study primary care, secondary care and diagnostic intervals and diagnostic windows. Additionally, we will explore reasons for emergency presentation for patients with and without LD. The Symptomatic Cohort will include patients presenting to a GP with a cancer feature between 2015 and 2019. We will examine the recorded cancer features, investigations and referrals for patients with and without LD. Multilevel logistic regression analysis will be used to investigate whether PwLD are less likely to be referred after presenting with a cancer feature than patients without LD.
Dissemination: The findings of this study will help identify reasons for and timings of delay in the cancer diagnostic pathway for PwLD and make recommendations for how this could be improved. We will deliver a stakeholder event, summaries of our findings in accessible format, in addition to academic papers and conference presentations.
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Refining and validating a clinical prediction model for childhood chronic kidney disease. — Lucy Plumb ...
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Refining and validating a clinical prediction model for childhood chronic kidney disease.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-09
Organisations:
Lucy Plumb - Chief Investigator - University of Bristol
Lucy Plumb - Corresponding Applicant - University of Bristol
Barnaby Hole - Collaborator - University of Bristol
Fergus Caskey - Collaborator - University of Bristol
Manish Sinha - Collaborator - Guy's & St Thomas' NHS Foundation Trust
Tim Jones - Collaborator - University of Bristol
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes:
Objectives 1 and 3
The outcome for these objectives is a new (incident) diagnosis of CKD, determined by READ, SNOMED-CT, ICD-10 or OPCS procedure codes or estimated glomerular filtration rate (GFR) data equivalent to <60ml/min/1.73m2.Objective 2
The outcome for objective 2 is a diagnosis of advanced kidney disease, defined as stage 4 or 5 CKD, which equates to an eGFR of <30ml/min/1.73m2 or a kidney replacement therapy (KRT) requirement. This will be determined by READ, SNOMED-CT, ICD-10 or OPCS procedure codes or estimated glomerular filtration rate (GFR) data equivalent to <30ml/min/1.73m2.Description: Lay Summary
Chronic kidney disease (CKD) is a condition where the kidneys donât work well or may have stopped working completely. In children, this is an important health problem as they grow and develop. It can also have long-lasting effects on their health and survival. Identifying the condition early can help prevent loss of kidney function. It may also help medical teams prepare children and families with the best treatments.
Currently, there is little research to know when to consider CKD in children and young people. Previous work has shown that the chances of having CKD are higher when certain symptoms and signs are reported in children. This work led to the development of a statistical model to predict CKD in children. The aim of this project is to further build on this work, to understand if additional health markers, in combination with signs and symptoms, can help detect children who go on to develop CKD. We will then test this model in a separate database, to see if it can be helpful to predict children who go on to be diagnosed with CKD.
This work aims to improve the timing of diagnosis for children with CKD. This supports research priorities for Kidney Research UK and the 2021 UK Rare Diseases Framework. During this project, young people and their families will be invited to help shape the study and ways to share findings.
Technical SummaryBackground:
Chronic kidney disease (CKD) in children is a significant health problem during a crucial period of growth and development, which is associated with high morbidity in later life. Timely detection enables access to treatments which may slow disease progression and mitigate long-term health risks. Understanding whether symptoms suggestive of CKD in children and young people are reported to primary care before diagnosis may provide an opportunity for earlier detection.Aim
Using a data science approach, this studyâs aim is to broaden an existing prediction model for the diagnosis of CKD in children and young people, and to validate this in a separate cohort.Methods
A historical cohort study nested in CPRD GOLD, a nationally representative primary care dataset. The study population will be children and young people aged 0-20 years (inclusive) within the CPRD dataset between January 1, 2000, and the extraction date. The primary outcome is a diagnosis of chronic kidney disease (or proxy for estimated glomerular filtration rate <60ml/min/1.73m2), identified using primary care or hospital records. Predicators of CKD, including signs, symptoms and additional clinical or patient features will be evaluated in regression models to identify variables predictive of a subsequent CKD diagnosis in the 6 months, 1 and 2 years prior to diagnosis. Conditional logistic and elastic net regression will be used to identify candidate predictors in combination. The final model will be internally validated using bootstrapping methods and calibration and performance assessed. External validation will be undertaken using the CPRD Aurum, a separate national primary care database.
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Do cholesterol-lowering treatments bring on or make atopic eczema worse? — Zenas Yiu ...
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Do cholesterol-lowering treatments bring on or make atopic eczema worse?
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-03
Organisations:
Zenas Yiu - Chief Investigator - University of Manchester
John Tetteh - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
John Bowes - Collaborator - University of Manchester
Sizheng Zhao - Collaborator - University of ManchesterOutcomes:
Incidence of eczema; eczema flare
Description: Lay Summary
Our skin has a protective layer that keeps moisture in and blocks out things that can irritate it. Cholesterol, a type of fat, is an important part of this layer and helps keep our skin healthy. People with eczema have a weaker barrier, which makes their skin dry, itchy, and easily irritated. Some experts are worried that medications used to lower cholesterol might weaken this skin barrier even more, which could make eczema worse or cause it to happen in the first place. Our study wants to find out if people who take cholesterol-lowering medications, like statins, are more likely to get eczema or have more flare-ups. To do this, we will examine patient health records from the Clinical Practice Research Datalink (CPRD).
Technical Summary
We will start by examining peopleâs health records who have just begun taking statins and compared to general population. This approach will provide insights into how initiating statin therapy impacts eczema. We will then look at statins versus statins+ezetimibe/PCSK. By comparing these groups, we hope to see if any of these medications are more linked to eczema. Next, we will look at people who already have eczema. We will see if they get more flare-ups during the times they are taking cholesterol-lowering drugs, compared to when they were not. These two ways of looking at the data will help us understand if lowering cholesterol with medication could affect skin health. This can help the medical community to know if these medications are safe for people with eczema.This study will examine the potential association between cholesterol-lowering medications and the risk of atopic eczema through 1) nested case-control study, 2) prevalent new-user cohort (PNU) and 3) Self-controlled case series (SCCS) analyses using patient health records from the Clinical Practice Research Datalink (Aurum) from 01/01/1998 to 31/12/2024. Aurum data will be linked to practice level rural-urban classification, patent Index of Multiple Deprivation, Hospital Episodes Statistics, mortality and Ethnicity.
Nested case-control and PNU Study will involve adults aged 18 years and older, with no prior eczema diagnosis before cohort entry. Patients will be divided into two groups (1) high-dose statins, with sub-groups including statins alone, ezetimibe plus statins, and PCSK9 inhibitors plus statins; (2) The SCCS will also involve patients aged 18 years and above without prior cholesterol-lowering medications, with sub-groups of ezetimibe and PCSK9 inhibitor monotherapies. We will use propensity score to adjust for confounding variables.
Logistic regression analysis will be utilised to evaluate associations in the nested case-control study. For the PNU study, the Kaplan-Meier survival analysis will be employed to assess survival function. Test of proportional hazards assumption will be conducted, and baseline hazard ratio will be estimated using either parametric models or semi-parametric model depending on the assumption test result. The hazard ratio and absolute risk will be estimated to quantify the effect size of the medications on eczema incidence.
The SCCS study will focus on adults with existing eczema who have been prescribed lipid-lowering therapies. Eczema flares will be defined using six criteria established by Dainty et al. (2024) (Appendix Table 1 and 2). Exposure periods will be based on individual prescriptions periods. Conditional Poisson regression analysis will be utilized to estimate relative rate ratio for eczema flare adjusting for potential confounders. These analyses will help clarify the association of cholesterol-lowering medications on eczema risk.
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Incidence rates of flares of auto-immune chronic diseases using European electronic healthcare record databases: SAFETY-VAC — Olaf Klungel ...
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Incidence rates of flares of auto-immune chronic diseases using European electronic healthcare record databases: SAFETY-VAC
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-07
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht UniversityOutcomes:
Occurrence of flares
Description: Lay Summary
This study is trying to find out if we can see how often flare-ups happen in certain long-lasting autoimmune diseases by using health records from databases in Europe, including Clinical Practice Research Datalink Aurum. In autoimmune diseases the body's immune system mistakes its own healthy tissues as foreign and attacks them. The main goal is to figure out how often these disease flare-ups happen without considering commonly used vaccines that might induce flare-ups and to look at flare-ups over 6 months and 12 months for such autoimmune diseases.
To do this, we will look at health records from January 1, 2017 and create groups of people who were diagnosed with these diseases during this time. They will make ten different groups, one for each disease. A person will only be included in a group if they have been observed for at least one day after January 1, 2017, and if they were first diagnosed with the disease after that date.
They will start checking on these people 90 days after their diagnosis, except for two diseases where they will start following them after 30 or 60 days instead. They will use a specific method to see how often flare-ups occur. The follow-up will stop if the person gets vaccinated, has a flare-up, or the study ends.
Technical SummaryThis study is part of a feasibility assessment to assess whether we can detect and provide background incidence rates of flares of auto-immune chronic diseases using European electronic healthcare record databases. The primary objective is to estimate the background (independent of vaccination) incidence rates of flares and the 6- and 12-month cumulative incidence of flares in patients with Gravesâ disease, Hashimotoâs thyroiditis, polyarteritis nodosa, autoimmune hepatitis, rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, erythema nodosum, systemic lupus erythematosus, and ulcerative colitis using European electronic healthcare data sources, including CPRD Aurum. A cohort design will be conducted during the period from January 1st, 2017, till the last data availability. Study cohorts start with a first diagnosis of the selected auto-immune diseases during the study period. The source population comprises all persons who can be potentially included in the study. Ten disease-specific study cohorts will be created, one for each event. Persons will be included in the incident disease-specific study cohorts if they have at least 1 day of observation after 1/1/2017 and a first recorded diagnosis of the disease of interest after 1/1/2017. Follow-up will start when study persons have completed 90 days after the disease diagnosis, except for autoimmune hepatitis and erythema nodosum where follow-up will start 30, and 60 days after the diagnosis, respectively. Flares outcomes will be assessed during follow-up using a standardised algorithm. For estimation of cumulative incidence, follow-up will be censored upon the earliest of a vaccination, a flare, or end of follow-up.
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Real-world Epidemiology, Treatment Patterns, Patient Characteristics, and Treatment Outcomes in Generalised Myasthenia Gravis (gMG) Management in England — Jennifer Davidson ...
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Real-world Epidemiology, Treatment Patterns, Patient Characteristics, and Treatment Outcomes in Generalised Myasthenia Gravis (gMG) Management in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-17
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Sariya Udayachalerm - Corresponding Applicant - Evidera, Inc
Achim Wolf - Collaborator - Evidera Ltd - UK
Alun Passey - Collaborator - Janssen Pharmaceuticals UK
Andre Ng - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Charles Percival - Collaborator - Janssen Pharmaceuticals UK
Gil Reynolds Diogo - Collaborator - Janssen Pharmaceuticals UK
Rebecca Joseph - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Robert Donaldson - Collaborator - Evidera Ltd - UK
Valerie Olson - Collaborator - Evidera Ltd - UK
Yi Lu - Collaborator - Evidera, IncOutcomes:
Incidence and prevalence of gMG; patient characteristics; prevalence and incidence proportion of refractory disease; treatment sequences; treatment patterns; discontinuation rates; all-cause (i.e., for any reason or condition) primary and secondary care HCRU and associated direct medical costs; HCRU and direct medical costs associated with OCS-related complications
Description: Lay Summary
Myasthenia gravis (MG) is a long-term autoimmune disease; an autoimmune disease happens when the body's immune system attacks the connection between nerves and muscles. Most people with MG have antibodies that target specific parts of this connection and experience muscle weakness and tiredness as a result. MG affects 150â250 people per million worldwide and 337 per million in the UK. Treatment aims to improve muscle strength and includes medications to boost nerve signals, steroids, immunosuppressants, and therapies like plasma exchange and immunoglobulin infusions. The majority of patients progress to generalized MG (gMG). gMG affects multiple muscle groups throughout the body, including those in the face, neck, arms, legs, and throat.
Technical Summary
This study will use anonymous records from general practitioners (GPs) and hospitals to understand what proportion of people living in England have gMG, the characteristics of people who have gMG (e.g., their age, gender, and any other health conditions), and what type of treatments they receive. We will also examine patientsâ contacts with healthcare systems after their diagnosis (e.g., number of appointments, hospital admissions) and describe the costs of this medical care.
The results of our study will increase the understanding of the burden and impact of gMG on peopleâs lives and the healthcare system in England, with the goal of guiding possible improvements in patient care and the well-being of people with gMG.Myasthenia gravis (MG) is a chronic autoimmune disorder causing muscle weakness and fatigue due to autoantibodies targeting the neuromuscular junction. MG affects 150â250 people per million globally and 337 per million people in the UK. MG usually first affects the eye muscles. Thereafter, onset in other muscles throughout the body results in the development of generalised MG (gMG).
Currently, there is no cure for gMG, and the treatment strategies aim to achieve remissionâin which patients experience normal or near-normal muscle function with minimal weakness or fatigueâ and to minimise medication-related side effects. Treatments include acetylcholinesterase (AChE) inhibitors, oral corticosteroids (OCS), non-steroidal immunosuppressants (NSISTs), rituximab, intravenous/subcutaneous immunoglobulin (IVIg/SCIg), plasma exchange (PLEX), thymectomy, and newer, non-reimbursed treatments.
In this retrospective cohort study, we will use primary and secondary care data from Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics (HES), the Index of Multiple Deprivation (IMD), and the Office for National Statistics (ONS) Death Registration to describe the incidence and prevalence of gMG, as well as treatment patterns and associated healthcare resource utilisation (HCRU) and costs in England. Adult patients (age â¥18 years) with at least one diagnosis code of gMG between 14 May 2015 and 31 March 2022 will be identified. The prevalence and incidence of gMG will be calculated. Characteristics of treatments will be analysed descriptively. For each treatment line, the median time to discontinuation, new LOT initiation, and the composite outcome will be calculated using Kaplan-Meier (KM) methods with 95% CIs and visualised through KM survival curves. For exploratory objectives, healthcare resource utilization (HCRU) and direct medical costs will be calculated.
These results will better our understanding of real-world treatment pathways and patterns of gMG and guide possible improvements in patient care and the well-being of people with gMG.
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Longitudinal Trajectories of Anti-Diabetic Medications from Pre-Conception to Delivery in United Kingdom Primary Care — Samy Suissa ...
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Longitudinal Trajectories of Anti-Diabetic Medications from Pre-Conception to Delivery in United Kingdom Primary Care
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-24
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Alaa Haboush - Collaborator - McGill University
Qi Zhang - Collaborator - Lady Davis Institute of the Jewish General Hospital
Robert Platt - Collaborator - McGill University
Sonia Grandi - Collaborator - University of TorontoOutcomes:
The study outcomes include medication trajectories use before, during, and after pregnancy, and baseline characteristics associated with each trajectory. The hypothesized trajectories in this study include several distinct groups. "Initiators" refers to women who were first prescribed an ADM within 90 days prior to their last menstrual period. "Discontinuers" are women who discontinued their ADM during pregnancy, while "Continuers" are who remained on the same ADM throughout the pregnancy. "Switchers" refers to women who changed their ADM regimen either before conception, during pregnancy, or after pregnancy. Additionally, baseline characteristics associated with each trajectory, would be determined using multivariable logistic regression.
Description: Lay Summary
Type 2 diabetes mellitus (T2DM) is a long-term condition where the body either becomes resistant to insulin, a hormone that helps control blood sugar levels, or fails to produce enough of it leading to high blood sugar. Maternal obesity and pre-gestational T2DM increase the risks for adverse pregnancy and neonatal outcomes, including miscarriage, birth trauma, and long-term health problems in both mothers and children. While medications like metformin and insulin are commonly used, prescriptions for noninsulin antidiabetic medications (ADM) have been increasing over the last 10 years, both for T2DM and weight reduction, which may lead to increases in unintended exposure during early pregnancy. Despite their widespread use and proven efficacy, there is currently a lack of sufficient information about their safety during pregnancy, with existing evidence being limited and conflicting. This uncertainty is particularly pressing as 47% of pregnancies in the United Kingdom are unintended, potentially leading patients to use these medications during early pregnancy without fully understanding the risks. Using data from the Clinical Practice Research Datalink (CPRD) Aurum and Gold linked to the Pregnancy Registry, this study aims to understand patterns of use of non-insulin ADMs over time and during pregnancy among reproductive aged women.
Technical SummaryType 2 diabetes mellitus (T2DM) is a chronic condition characterized by insulin resistance leading to hyperglycemia. Maternal obesity and pre-gestational T2DM elevate the risk of adverse pregnancy outcomes, including miscarriage, birth trauma, and long-term health complications for both mothers and offspring. While metformin and insulin are standard treatments, the use of non-insulin antidiabetic medications (ADMs) has increased for both glycemic control and weight management, resulting in unintended exposure during early pregnancy. Despite their widespread use, the safety of non-insulin ADMs during pregnancy remains under-researched, with current evidence being limited and conflicted. This is concerning given that 47% of pregnancies in the United Kingdom are unintended, potentially leading to inadvertent use of these medications during early gestation without comprehensive risk awareness.
Utilizing data from the Pregnancy Register within the CPRD Aurum and Gold, we will identify longitudinal trends in the prescriptions of ADM over-time in women who got pregnant UK from 2010 to 2022 using a longitudinal k-means trajectory modelling.
In this study, we hypothesize that several prescription trajectories exist, each characterized by different patient behaviors and treatment patterns. These include: "Initiators" refers to women who were first prescribed an ADM within 90 days prior to their last menstrual period. "Discontinuers" are women who discontinued their ADM during pregnancy, while "Continuers" are those who remained on the same ADM throughout the pregnancy. "Switchers" refers to women who changed their ADM regimen either before conception, during pregnancy, or after pregnancy. Ultimately, the specific trajectories will be refined based on the data.Multivariable logistic regression will be used to determine baseline characteristics associated with each prescription trajectory. The results of this study will provide a comprehensive overview of prescription trends and safety profiles of ADMs in pregnant women with T2DM, facilitating future research on best practices for treating patients with pre-gestational diabetes.
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A multi-state model for cardiometabolic-renal conditions in women who have been pregnant — Francesca Crowe ...
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A multi-state model for cardiometabolic-renal conditions in women who have been pregnant
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-29
Organisations:
Francesca Crowe - Chief Investigator - University of Birmingham
Steven Wambua - Corresponding Applicant - University of Birmingham
KRISHNARAJAH NIRANTHARAKUMAR - Collaborator - University of BirminghamOutcomes:
Risk of cardiometabolic-renal conditions including Cardiovascular disease, type 2 diabetes, hypertension and chronic kidney disease
Description: Lay Summary
There are currently tools (QRISK®-3 and QDiabetes) for calculating a heart disease and diabetes âscoreâ based on factors such as age, ethnicity and social economic status. These tools predict how likely it is someone will have a heart attack or diagnosis for diabetes for the first time in the next 10 years. Many General Practitioners (GPs) in the UK use these tools to calculate a risk score during consultations with their patients. If their risk score is higher than recommended, patients can be referred for further treatments to help reduce their risk.
Technical Summary
These tools are very accurate, but they only consider a small amount of information about reproduction and pregnancy. Including these features into the tool might help improve prediction of these conditions in women.
Our aim is to test whether adding reproductive and pregnancy-related features to those from existing computer models helps make it better at predicting the risk of heart disease, diabetes, kidney disease and high blood pressure in women after childbirth.
We will use data from primary care records to determine reproduction and pregnancy features and create computer models to decide whether adding pregnancy history to features from existing tools helps improve risk prediction.
The updated tools will inform further research and help GPs make decisions about which women
are more likely to develop these conditions after pregnancy. By finding out women who are most at risk of these conditions, treatments to reduce their risk can be accessed benefiting the women, their families and the NHS.Aims: The aim of this study is to develop a multistate model for cardiovascular disease (CVD), type 2 diabetes, hypertension and chronic kidney disease (CKD) in women who have been pregnant
Study will be divided into two parts.
Study 1- Using the CPRD Aurum Pregnancy Register, cohort of women who have been pregnant will be established.
We will compare the incidence of each of the four outcomes (CVD, type 2 diabetes, hypertension and chronic kidney disease (CKD)) in women with and without each of the reproductive factors and pregnancy complications (the exposures). The outcomes and exposures will be ascertained by both primary care, linked HES records and MBL records. Hazard ratios to quantify association between exposures and the outcomes will be estimated using a series of adjusted cox proportional hazards regression models.
Study 2 - Using the cohort established in Study 1, we will develop a multistate risk prediction model of the cardiometabolic-renal conditions in the postpartum period following practical approaches described previously and taking a clock-reset time scale, where time resets to zero after each transition [1,2,3]. This approach ensures that we focus on the time from one event to the next event or death, allowing for a comprehensive analysis of the intervals between events [1,2,3]. Deaths will be ascertained using the ONS records. Candidate predictors will be identified from existing risk prediction models for these conditions, Study 1 and from discussions with clinicians and patient research partners. For each transition-specific model, hazard ratios and their confidence intervals for each predictor will be estimated and the overall model fit will be assessed based on Cox-Snell residuals. We will evaluate the model using discrimination (C-statistics), calibration (calibration plots and curves), and clinical utility (decision curves) at different time points (e.g., at 5 years and 10 years) using CPRD Gold.
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Prevalence of mental health morbidities prior to pancreatic cancer diagnosis and their impact on time to diagnosis, survival and pancreatic cancer treatment. — Jingya Wang ...
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Prevalence of mental health morbidities prior to pancreatic cancer diagnosis and their impact on time to diagnosis, survival and pancreatic cancer treatment.
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-29
Organisations:
Jingya Wang - Chief Investigator - University of Birmingham
Shahd Mohamed - Corresponding Applicant - University of Birmingham
James Martin - Collaborator - University of Birmingham
Jennifer Cooper - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of BirminghamOutcomes:
Study one: prevalence of mental health morbidities in patients with pancreatic cancer in England.
Study two: Diagnostic delays, defined as cases that took more than the median time to diagnosis of pancreatic cancer.
Study three:
primary outcome: 1-year all-cause mortality
secondary outcomes:
⢠Surgery
⢠Chemotherapy or radiotherapy (as one categorical variable)Description: Lay Summary
Background
Pancreatic cancer is one of the six least survivable cancers in the UK. Seven in ten patients with pancreatic cancer die without receiving treatment. When diagnosed early, curative surgery is possible. Unfortunately, early symptoms are often vague, this makes diagnosis difficult. Of all cancers, depression is most common in pancreatic cancer patients before diagnosis. New depression can present in people with undiagnosed pancreatic cancer. So, when they start to lose weight or eat less, doctors may think it is due to the depression, when actually it is due to the cancer. This can delay the diagnosis of pancreatic cancer. Also, patients with depression may not seek help early before they develop other pancreatic cancer symptoms.Purpose
If mental health problems such as depression may be an early sign of pancreatic cancer, itâs essential to:
1) understand how common mental health problems are before pancreatic cancer diagnosis.
2)Investigate factors linked with delays in diagnosis.
3)Investigate its impact on survival and pancreatic cancer treatments.Importance
Technical Summary
Research suggests that new mental health problems can be an early feature of pancreatic cancer. This study will find out how common this is. It will also find out if having a mental health problem before pancreatic cancer is diagnosed can affect time taken to diagnose the cancer, survival and treatment of the cancer. This will help raise awareness of this issue among doctors as well as patients.Aim:
To investigate the prevalence of mental health morbidities (MHM) prior to pancreatic cancer (PC) and their impact on diagnosis, treatment and prognosis.Methods:
Data sources: Index of multiple deprivation data set, HES-APC and NCRAS linkage will be used.Study period:01/09/2005-31/12/2023
Source population for all studies: patients with PC diagnosis (defined by either SNOMED-CT or ICD-10 codes) aged ⥠18 between 01/09/2005-31/12/2023.
Exclusions: Individuals with pancreatic neuroendocrine tumor or papillary mucinous neoplasms, or diagnosis within 2 years after registration date or history of PC.
Study one:
To describe the prevalence of MHM prior to PC diagnosis- a cross-sectional study using the source population.Analysis: Descriptive analysis of MHM status of patients before PC diagnosis.
Study Two
To investigate factors associated with diagnostic delays: case-control.Of the source population, those with at least one PC-related symptom recorded in primary care during 24-months before PC diagnosis will be included.
Exposures: factors potentially associated with time-to-diagnosis of PC.
Case: patients who took more than median time from first symptom to diagnosis.
Control: Those with less than or equal to median time to diagnosis.Analysis: multivariable logistic regression models to assess the association between patient characteristics and those who took more than median time to diagnosis.
Study three:
Aim:
To compare the treatment and prognosis of PC between patients with and without MHM before PC diagnosis.
⢠Exposure: patients with MHM
⢠Comparator: propensity-matched PC patients without MHM
⢠Primary outcomes: 1-year all-cause mortality
⢠Secondary outcomes: PC treatment (surgery or chemotherapy/radiotherapy) between matched cohorts.
⢠Analysis: Multivariable logistic regression analysis will be carried out clinically relevant covariates to calculate crude and adjusted odds ratio and their corresponding 95% CI.Intended public health benefit of the research
To raise awareness of this issue among both physicians and patients.
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An observational study to examine the association of body mass index and weight loss comparing those with obesity and without, with elective surgical outcomes, and long-term weight change. — Mohammad Ali ...
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An observational study to examine the association of body mass index and weight loss comparing those with obesity and without, with elective surgical outcomes, and long-term weight change.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-22
Organisations:
Mohammad Ali - Chief Investigator - University of Leicester
Claire Madigan - Corresponding Applicant - Loughborough University
Francesco Zaccardi - Collaborator - University of Leicester
Gavin Murphy - Collaborator - University of Leicester
Gemma Taylor - Collaborator - University of Bath
Kamlesh Khunti - Collaborator - University of Leicester
Olasunkanmi Oyolola - Collaborator - Loughborough University
Rebecca Hardy - Collaborator - Loughborough University
Sharmin Shabnam - Collaborator - University of Leicester
Tom Abbott - Collaborator - Barts and the London Queen Mary's School of Medicine and DentistryOutcomes:
1. Mortality/ survival and long term survival at 30 days and one year.
2. Perioperative complications up to 30 days
Clavien-Dindo classification(2)
The Comprehensive Complication Index (CCI)(3)
Infection and sepsis outcomes(4)
Cardiovascular outcomes (5)
Pulmonary outcomes (6)
Renal outcomes (7)3. Hospital resource use
Length of hospital stay (LOS)
Length of time in the different levels of intensive care as based on the intensive care society classification(8).
Admission to differing intensive care levels as a binary variable
Readmittance within 30 days
Re-operation rate up to 30 days4. Surgical Outcomes
Surgical failure5. Weight change over five years post-surgery
Description: Lay Summary
People with obesity are at higher risk of having complications during and after surgery. This includes a higher chance of problems with anaesthesia, longer surgeries, slower healing, and staying in the hospital longer. However, we donât fully understand if these risks are the same for all surgeries, how often these complications happen and if they happen to all types of people.
Itâs clear that obesity makes surgery and recovery more challenging, but we donât yet know if losing weight before surgery can help improve the results and recovery process. The main goals of this study are to find out if living with obesity is associated with worse surgical outcomes and if losing weight before surgery can lead to better surgery outcomes and faster recovery for people living with obesity.
Technical SummaryThe main aims of our study are to investigate whether living with obesity is associated with adverse surgical outcomes and if patients lose weight before surgery does that mitigate those outcomes within England using CPRD data linked with HES and ONS.
This is a retrospective cohort study of patients that have received elective surgery. The exposed group will consist of all individuals who have had major elective surgery and a weight/ BMI measure before their surgery between 01/01/2000 and the latest available dataset from CPRD. The index date will be the date of surgery. To describe the data, we plan to present the descriptive statistics as number and proportion for categorical (ordinal and nominal) data, mean (standard deviation) for continuous data and median (interquartile range) for skewed continuous data. Associations between BMI and surgical outcomes will be analysed using generalised linear models and/or Cox proportional hazards models using BMI as a continuous and categorical variable. Associations between BMI change, and surgical outcomes will be analysed using the same models. We will take account of the time varying nature of the exposure in constructing the measure of change and in the adjustment for confounders. For both models we will adjust for confounders and complete stratified analyses by surgical specialities, sex, ethnicity, age, socioeconomic status.To examine weight change over time (up to five years) post-surgery we will develop models based ion our previous analyses. If participants have BMI measured at multiple time points post-surgery, we will consider using multi-level modelling to account for the correlation of BMI within individuals. These findings will provide evidence about the association of BMI and adverse surgical outcomes which can inform policy changes and potential interventions.
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Real-world effectiveness of the recombinant zoster vaccine in immunocompromised populations — Samy Suissa ...
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Real-world effectiveness of the recombinant zoster vaccine in immunocompromised populations
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-24
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Simon Galmiche - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Herpes zoster, postherpetic neuralgia (in the 90-365 days following the initial diagnosis of herpes zoster), ophthalmic herpes zoster, pneumonia (as a negative control outcome), organ transplant rejection.
Description: Lay Summary
Herpes zoster usually manifests through a painful rash on the trunk. It is due to the reactivation of the chickenpox virus (varicella zoster virus). While it is usually not life-threatening and resolves spontaneously, it can be very painful, sometimes for several months to years after the initial rash, and severe complications can occur, particularly when the rash touches the eye. A new vaccine has been used recently in older adults with low immune defenses. These persons include persons with cancer, an autoimmune disease (e.g., rheumatoid arthritis, lupus), an organ transplant (e.g., kidney or heart transplant), or taking high-dose corticosteroids, and all have a higher risk of developing herpes zoster. Yet, the vaccine was mainly tested in people with a functional immune system, and we do not know if it works in people with low immunity. Using routinely collected data from patients seeing their general practitioner in the UK, we wish to measure the effectiveness of this newer herpes zoster vaccine in persons with low immunity, by comparing the risk of developing herpes zoster between vaccinated and unvaccinated persons. We hope that the results will help these persons when considering vaccination. If we show that the vaccine does not protect well enough or that the protection quickly decreases, future research could be needed to optimize the protection of people with low immunity, e.g, through the development of newer vaccines or repeated vaccine doses.
Technical SummaryThe recombinant zoster vaccine (RZV) has been rolled out in immunocompromised populations in the UK since September 2021. Pivotal phase 3 trials show high efficacy in immunocompetent populations (1,2). Despite one efficacy study in patients with recent autologous hematopoietic stem cell transplantation (3) and several other studies showing good immunogenicity (post-vaccine anti-VZV immunity) across various immunocompromised populations (4â7), evidence on the effectiveness is limited in these populations, whereas the burden of herpes zoster is highly concentrated in these (8).
In a cohort study using a new user design adapted from the prevalent new-user design approach for settings without active comparator, which will account for time since immunosuppression onset, opportunity for vaccination, and avoid time-related biases (9,10), we will match (1:1 ratio) vaccinated persons with unvaccinated persons (using time-conditional propensity score accounting for confounders including healthcare-seeking behaviour) within the same subgroup of immunocompromising conditions (patients with hematological malignancy, solid cancer with chemotherapy or radiotherapy, hematopoietic stem cell transplant, solid organ transplant, immune-mediated inflammatory disease (IMID) on oral corticosteroids or immunosuppressive treatment, and patients on high-dose oral corticosteroids regardless of the indication). We will estimate the effectiveness of the recombinant zoster vaccine against herpes zoster defined through clinical diagnoses combined with antiviral prescription. Secondary outcomes will include postherpetic neuralgia and ophthalmic zoster. We will assess potential residual confounding using pneumonia as a negative control outcome.
Assessing vaccine effectiveness and its duration in immunocompromised populations is essential to advise patients and physicians as vaccine coverage remains low in these populations (16.8% in July 2024 according to the UK Health Security Agency), and to identify any populations where the current vaccine strategy would prove insufficient, which will help guide future research efforts.
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Target Trial Approach to Evaluate Strategies for Improving Cardiovascular Outcomes — Samy Suissa ...
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Target Trial Approach to Evaluate Strategies for Improving Cardiovascular Outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-07
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Kristian Filion - Collaborator - McGill University
Qi Zhang - Collaborator - Lady Davis Institute of the Jewish General Hospital
Robert Platt - Collaborator - McGill University
Yi Li - Collaborator - McGill University
Yu-Han Chiu - Collaborator - University of PennsylvaniaOutcomes:
Stroke and systemic embolism; Major bleeding; All-cause mortality
Description: Lay Summary
Atrial fibrillation (AF) is a condition where the heart beats irregularly, increasing the risk of stroke. For many years, patients with AF have been prescribed a blood thinner called warfarin to prevent stroke. However, warfarin interacts with food and drugs, and hence requires frequent check-ups. To address the issues, new blood thinners called non-vitamin K antagonist oral anticoagulants (NOACs) were developed, including dabigatran, rivaroxaban, apixaban, and edoxaban.
Large clinical trials have shown that NOACs work as well as warfarin in preventing strokes, with fewer side effects like bleeding. However, there is also limited guidance on how to choose the best NOAC for each patient. Researchers have tried to determine factors that might affect how NOACs work, but looking one factor at a time isn't very helpful for clinical decisions. Machine learning methods that consider multiple factors simultaneously have been proposed, but most do not give reliable estimates for decision making. Recently, a new method called sorted group average treatment effects (GATEs) has been developed, allowing for reliable results on how different treatments work for different patients. Despite its potential, this method has not been widely used in real-world settings.
Our project aims to understand how different NOACs affect stroke, serious blood clots, major bleeding, and death in AF patients. We will compare the four NOACs, and use the GATEs method to determine which types of patients benefit most from each NOAC. The findings will guide doctors in choosing the best NOAC for individual AF patients.
Technical SummaryAtrial fibrillation (AF) is the most common arrhythmia and a potent risk factor for stroke and death. Anticoagulants have been used to control thromboembolic complications in patients with AF. Four landmark randomized controlled trials have shown that non-vitamin K antagonist oral anticoagulants (NOACs), including dabigatran, rivaroxaban, apixaban, and edoxaban, are at least as effective as warfarin in preventing stroke and systemic embolism, with lower risks of bleeding. Consequently, the current clinical guidelines recommend NOACs as the first-line treatment for AF. However, no trial has directly compared the NOACs; observational studies that compared different NOACs often did not include edoxaban, which was approved more recently. There is also no guidance on selecting specific NOAC based on individual patientsâ characteristics.
Existing studies have identified potential modifiers of the effect of NOACs from subgroup analyses, but the one-variable-at-a-time approach may be inadequate for clinical decision-making. To better capture heterogeneous treatment effects (HTE), machine learning methods that consider multiple variables simultaneously have been proposed. However, most off-the-shelf machine learning methods have difficulties in obtaining uniform valid inference under a large class of machine learning algorithms. Recent methodsâsorted group average treatment effects (GATEs) âaddress these limitations, allowing for valid inference on heterogeneous treatment effects in randomized trials using any generic machine learning model. However, this method has not been applied in real-world settings.
Our project aims to identify HTE in the effectiveness and safety of four NOACs in AF patients using CPRD data. We will first emulate a four-arm trial for the NOACs on the risk of stroke, systemic embolism, major bleeding, and all-cause mortality. Then, we will adapt the GATEs method for observational studies, compare various ML algorithms in a simulation study, and apply them to CPRD. The findings will enhance understanding of NOAC treatment effects and support patient-centered recommendations for AF patients.
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Real-World Comparative Outcomes in Multiple Myeloma: Evaluating Maintenance Therapy, Bispecific Antibodies, and Treatment Regimens — Ehtesham Iqbal ...
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Real-World Comparative Outcomes in Multiple Myeloma: Evaluating Maintenance Therapy, Bispecific Antibodies, and Treatment Regimens
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-03
Organisations:
Ehtesham Iqbal - Chief Investigator - Parexel International Limited (UK)
Nathan Lee - Corresponding Applicant - Parexel International LLC (USA)
Jaime Smith - Collaborator - Parexel International LLC (USA)
Stacy Charlerie - Collaborator - Parexel International Co., LtdOutcomes:
Primary outcomes:
1. Time-to-relapse or progression (defined by new codes for relapse or treatment escalation).
2. Overall survival (recorded death or practice de-registration).
Secondary outcomes:
1. Adverse events (infections, venous thromboembolism (VTE), chronic kidney disease (CKD), anemia).
2. Treatment switching or discontinuation, captured through primary care prescribing patterns.Description: Lay Summary
Multiple myeloma is a cancer of plasma cells that often requires complex treatments. This study will use real-world healthcare data to understand how treatment approaches like drug regimens influence patient outcomes. We will look at how long patients remain disease-free after treatment and compare how well they tolerate different treatments. We will also analyze risk factors such as infections, blood clots, and kidney diseases. We hope to uncover which treatment approaches offer the best balance of effectiveness and safety.
Technical SummaryThe treatment of multiple myeloma has changed dramatically in the past decade. The increase in the number of active agents has generated numerous possible drug combinations that can be used in the first-line and relapsed settings. As a result, there is considerable confusion about the choice of regimens for initial therapy, role of transplantation in the era of new drugs, end points for therapy, and the role of maintenance therapy.
This will be a retrospective observational cohort study that will use both CPRD Aurum and CPRD GOLD primary care datasets to evaluate outcomes for multiple myeloma (MM) patients treated between January 2016 and January 2025. Patients aged â¥18 with a primary care diagnosis of MM (defined by Read or SNOMED codes) will be included.
Analyses will include descriptive statistics, survival analyses (Cox proportional hazards, KaplanâMeier), propensity score adjustments for confounding, and exploratory time series machine learning models (Recurrent Neural Networks, Transformers) to predict relapse risk and identify treatment patterns.
Subgroup analyses will stratify results by age, comorbidity burden, and initial treatment regimen. The overall objective is to provide real-world evidence on effectiveness, safety, and tolerability across MM treatment strategies in routine clinical practice.
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Ethnic differences in the management and severity of Chronic Obstructive Pulmonary Disease in England — Jennifer Quint ...
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Ethnic differences in the management and severity of Chronic Obstructive Pulmonary Disease in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-22
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Rutendo Muzambi - Corresponding Applicant - Imperial College LondonOutcomes:
1) Yearly proportion of current users of inhaled COPD medication
2) Severity of COPD exacerbation
3) COPD-related or cardiovascular-related mortalityDescription: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a condition affecting the lungs that is predominantly caused by tobacco smoking. It causes day to day symptoms of cough, shortness of breath and sputum production. It is the third leading cause of death worldwide. The number of people living with COPD is rising with over a million people currently affected by the condition in England. Worsening of COPD symptoms such as cough and breathlessness beyond normal day-to-day symptoms is referred to as COPD exacerbation which is associated with an increased risk of future exacerbations, hospitalisation and death. Previous studies have found inequalities in the management and severity of COPD however little is known about ethnic differences, particularly in more recent years. This study will use routinely collected data from English General Practitioners (GPs) and hospitals to compare the prescribing of COPD medications and severity of COPD (COPD exacerbation and death) for people of European, South Asian and African Caribbean origin. By examining differences by ethnicity, these findings may inform strategies to optimise drug management in primary care, reduce COPD exacerbations and hospitalisations.
Technical SummaryCOPD is a leading cause of mortality worldwide and exacerbations of COPD are associated with increased risk of successive events, accelerated decline in lung function, poor prognosis, reduced quality of life and mortality. While previous studies have found inequalities in the management and severity of COPD, few studies have examined ethnic differences particularly in recent years.
We will use primary care electronic health records data from the Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics (HES) inpatient (APC) data to carry out a cohort study examining ethnic differences in the management and severity of COPD between 2007 and the most recent available linked data. We will describe the prevalence of COPD medication including time trends before and after the COVID-19 pandemic, stratified by ethnic group. We will use Cox proportional hazards regression models to estimate hazard ratios for the association between ethnicity and 1) moderate and severe COPD exacerbations and 2) COPD-related and cardiovascular disease related mortality. Our findings will inform clinical practice in optimising drug management in primary care, reduce COPD exacerbations and hospitalisations.
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Empagliflozin and sodium-glucose co-transporter-2 inhibitor (SGLT2i) uptake, initiation, and treatment patterns among patients with chronic kidney disease (CKD) — Jacob Hunnicutt ...
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Empagliflozin and sodium-glucose co-transporter-2 inhibitor (SGLT2i) uptake, initiation, and treatment patterns among patients with chronic kidney disease (CKD)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-29
Organisations:
Jacob Hunnicutt - Chief Investigator - Boehringer Ingelheim GmbH
Jacob Hunnicutt - Corresponding Applicant - Boehringer Ingelheim GmbH
Chengan Du - Collaborator - Boehringer-Ingelheim International GmbHOutcomes:
Primary Outcomes: Empagliflozin use and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use, other chronic kidney disease (CKD) related medication use, empagliflozin initiation and SGLT2i initiation
Secondary Outcomes: patient characteristics (overall, stratified by SGLT2i use, stratified by other key patient characteristics), treatment patterns including empagliflozin/SGLT2i discontinuation and re-initiation, predictors of empagliflozin/SGLT2i use/initiation/discontinuation
Description: Lay Summary
Chronic kidney disease (CKD) is a common health issue affecting about 10% of people worldwide. Recently, a new treatment called empagliflozin, which is a type of medication known as a sodium-glucose co-transporter-2 inhibitor (SGLT2i), was approved in the UK on September 7th, 2023.
This study aims to use electronic medical records to understand how often empagliflozin and other similar medications are used by patients with CKD. It will look at how many patients were already using these medications when empagliflozin was approved and how many started using empagliflozin and SGLT2i more broadly after its approval.
The main goals of this study are to find out how common the use of these medications is among CKD patients and to characterize any patterns in their use. The study will also describe the characteristics of the patients and look for factors that might predict whether they will start or stop using these medications.
The results of this study will help understand the use of empagliflozin and similar medications among CKD patients in the UK and highlight any gaps in following medical guidelines for empagliflozin and SGLT2i.
Technical SummaryChronic kidney disease (CKD) is one of the most prevalent noncommunicable diseases and affects ~10% of the global population. Recently, new treatment for CKD have become available, includes empagliflozin, a sodium-glucose co-transporter-2 inhibitor (SGLT2i), which was approved in the UK on September 7th, 2023.
This retrospective descriptive cohort study will leverage electronic medical record data from CPRD Aurum to quantify baseline baseline empagliflozin/SGLT2i use at the time of empagliflozin CKD approval among patients with CKD, as well as treatment initiation during follow-up among those not receiving empagliflozin/SGLT2i during the baseline period. The study period will range from September 7th, 2023 up to December 31, 2025 (pending data availability at end of the study).
The study population includes patients with diagnosed CKD who are alive and aged 18 years or older on the UK empagliflozin CKD approval date. Three cohorts will be defined to achieve the different objectives: the CKD approval date cohort, the empagliflozin/SGLT2i initiator cohort, and the empagliflozin/SGLT2i initiator and subsequent discontinuation cohort.
The study will use descriptive statistics to summarize baseline characteristics of the patient population (overall and stratified by key characteristics of interest) and time-to-event methods to estimate the cumulative incidence of treatment initiation/discontinuation/re-initiation (using Kaplan-Meier based cumulative incidence estimates) and Cox models to estimate the association between patient characteristics and treatment initiation/discontinuation.
The results of this study will help characterize the UK CKD patient population, use and uptake of empagliflozin and SGLT2i, and treatment patterns among those initiating treatment. These results will also highlight potential gaps in the extent to which medical guidelines for SGLT2i/empagliflozin use in patients with CKD are followed.
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Clinical and demographic characterisation, healthcare utilisation and outcomes associated with adults with cardiovascular disease managed through virtual wards, hospital at home and remote monitoring: a retrospective observational cohort study — Annika Jodicke ...
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Clinical and demographic characterisation, healthcare utilisation and outcomes associated with adults with cardiovascular disease managed through virtual wards, hospital at home and remote monitoring: a retrospective observational cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-17
Organisations:
Annika Jodicke - Chief Investigator - University of Oxford
Ali Hosin - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
These outcomes will be measured in (i) all patients, and (ii) patients with the specified cardiovascular diseases:
1. Incidence (n(person/100â000 person-years) of virtual ward codes over the last 10 years reported in an annualised fashion;
2. Following virtual ward usage:
a. 1-year mortality;
b. 30-day hospital readmission rate;3. Resource utilisation; in the 1, 6 and 12 months following virtual ward discharge
a. GP visits;
b. Emergency department (ED) visits;
c. Outpatient appointmentsDescription: Lay Summary
More people are living with heart disease, and new ways of caring for them are needed. Increasingly digital healthcare (healthcare aided through technology) is being offered, including remote consultations (through video or telephone) and virtual wards (hospital level care at home). However, it is not known how widely these pathways are used in the UK, and how their use has changed over time. Another unknown is whether these provide the same, better, or worse care than traditional consultations. It is also not known what sorts of patients are being offered these modes of healthcare, and what happens to patients after receiving healthcare through these pathways. This study focuses on common heart conditions including heart failure, atrial fibrillation (irregular heartbeat) and aortic stenosis (heart valve narrowing). This study seeks to use routine data (data collected as part of patientsâ usual care) to understand more about how digital healthcare usage in patients with heart disease has changed over time, the sorts of patients being offered digital healthcare and how they use healthcare after being cared for through these pathways. This study will help to improve access to digital healthcare pathways, and understand the impact of these pathways on the wider health system.
Technical SummaryBackground:
Digital healthcare technologies including remote monitoring and virtual wards have grown rapidly and organically, which has been catalysed by the Covid-19 pandemic. Cardiovascular disease has been highlighted as an exemplar condition for management on a virtual ward (others including respiratory infection and frailty). Bodies such as NHS England and NICE have called for evidence generation for virtual ward platform technologies. Though high level data exists through national situation reporting (SitRep) submissions, these only offer crude estimations of virtual ward capacity and occupancy. There is a need to understand more about the characteristics of cardiovascular patients being offered these technologies and the impact of these pathways on the wider healthcare system. This study aims to bridge this gap as well as examine the utility of evaluating digital healthcare through routine data sources such as CPRD.Study design:
Retrospective observational cohort studyPopulation:
All adults aged 18 or over between 2015-2024 in CPRD meeting these criteria will be eligible for study inclusion:
1. Patients treated on virtual wards or hospital at home, or who have undergone remote monitoring
2. Patients with heart failure, atrial fibrillation and aortic stenosisExposure(s)/Code(s)/Procedure(s) of interest:
Virtual wards, hospital @ home and remote monitoringVariables:
Patients who are treated through virtual wards, hospital @ home and remote monitoring will be based on procedure codes in CPRD Aurum/GOLD (mapped to the OMOP Common Data Model). The characteristics of these patients will be summarised, and the use of these treatment modalities over time will be assessed.Analyses:
Descriptive analysis of demographic and clinical characteristics of the study population, incidence of digital healthcare related codes, 1-year mortality, 30-day readmission rate (until 31/03/23), resource utilisation (GP visits, emergency department visits (until 31/03/20), hospital admissions(until 31/03/23)).
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Leukotriene Receptor Antagonists and the prevention of Major Adverse Cardiovascular Events in Patients with Asthma — Samy Suissa ...
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Leukotriene Receptor Antagonists and the prevention of Major Adverse Cardiovascular Events in Patients with Asthma
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-17
Organisations:
Samy Suissa - Chief Investigator - Lady Davis Institute of the Jewish General Hospital
Samy Suissa - Corresponding Applicant - Lady Davis Institute of the Jewish General Hospital
Christel Renoux - Collaborator - McGill University
Julien Quang Le Van - Collaborator - University Of Montreal
Pierre Ernst - Collaborator - McGill University
Sarah Beradid - Collaborator - Lady Davis Institute of the Jewish General HospitalOutcomes:
The primary outcome will be the composite of major adverse cardiovascular events (MACE), defined by myocardial infarction, ischemic stroke, and cardiovascular death. Secondary outcomes include an extended composite of the primary outcome (MACE+), defined by myocardial infarction, ischemic stroke, cardiovascular death, transient ischemic attack, or unstable angina. We will also assess the individual components of the MACE+ composite if the number of events is sufficient to allow for meaningful analysis. All the components will be identified using ICD-10 codes (appendix 1) from the HES admitted patient care and ONS death registration databases.
Description: Lay Summary
Heart disease is a major cause of death, mostly due to a condition called atherosclerosis, where arteries get clogged and inflamed because of the accumulation of fat in the blood. Inflammation is known to play an important role in this process. Leukotriene receptor antagonists, a class of medication used for asthma (a chronic lung disease), works by reducing inflammation caused by leukotrienes, substances involved in the bodyâs defense system. They may also help lower the inflammation that contributes to heart disease.
We will conduct a study using the CPRD database to explore whether leukotriene receptor antagonists reduce the risk of heart attacks, strokes (a blood clot in the brain), and heart-related deaths among patients with asthma. We will study patients with asthma aged 40 years and more who have been prescribed the addition of either a leukotriene receptor antagonist or a long-acting beta-agonist to an inhaled corticosteroid therapy (two other classes of medications used for asthma). The analysis will compare the number of patients who are diagnosed with heart problems during follow-up in those treated with an inhaled corticosteroid and a leukotriene receptor antagonist with those treated with an inhaled corticosteroid and a long-acting beta agonist. Additionally, a broader range of heart-related issues and their individual components will be examined to gain a more complete picture. Several additional analyses will be conducted to ensure our findings are reliable and consistent.
Technical SummaryCoronary artery disease is a leading cause of mortality and morbidity globally, primarily driven by atherosclerosis, an inflammatory process involving interactions between lipids and immune responses. Leukotriene receptor antagonists reduce inflammation by blocking cysteinyl leukotriene receptor 1 and have an established safety profile for asthma, though they have been linked to neuropsychiatric events ranging from sleep disturbances to suicidal thoughts. Given their anti-inflammatory properties and role in modulating the leukotriene pathway, repurposing leukotriene receptor antagonists for the treatment of coronary artery disease may represent a novel and promising therapeutic approach.
We will conduct a population-based cohort study using the CPRD database to evaluate the association of leukotriene receptor antagonists with the risk of major adverse cardiovascular events (MACE), specifically myocardial infarction, ischemic stroke, and cardiovascular death, among patients with asthma. We will assemble a cohort of patients with asthma, aged 40 years and more, with the addition of either a leukotriene receptor antagonist or a long-acting beta-agonist to an inhaled corticosteroid therapy using the prevalent new user design. Time-conditional propensity scores will be used to control for confounding. We will calculate incidence rates of MACE for each exposure group and estimate weighted HRs with 95% CIs using Cox proportional hazards models. In secondary analyses, we will evaluate the incidence of an extended composite of the MACE and its individual components. Several sensitivity analyses will be performed to assess the robustness of our results.
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Characterising and assessing outcomes in patients with common cancers — Eng Hooi Tan ...
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Characterising and assessing outcomes in patients with common cancers
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; NCRAS Tumour / Treatment data; Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-04-29
Organisations:
Eng Hooi Tan - Chief Investigator - University of Oxford
Danielle Newby - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
All outcomes will be measured separately for each cancer site of interest (breast, lung, colorectal, head and neck, brain, pancreas, uterine, and cervix)
For Objective 1: Survival and symptoms of disease. Clinical phenotyping results from both LLMs and traditional clinical method will be compared.
For Objective 2: Survival and adverse events (such as fatigue, nausea, hair loss, mouth ulcers, infection, treatment complications, hospitalisation etc) from treatment
For Objective 3: Clinical progression, metastasis, survivalDescription: Lay Summary
Cancers of the breast, lung, bowel, head and neck, brain, pancreas, and womb are among the most common cancers in the UK. Current clinical guidelines group patients according to their risk during diagnosis and are used to predict their disease progression. There are many different treatment options and treatment patterns are complex. There is no consensus over the optimal categorisation and treatment strategy.
Technical Summary
This study has the following aims:
1) to describe demographics and clinical characteristics of cancer patients according to treatment modes and describe their treatment patterns
2) to describe and compare various cancer treatment side effects and effectiveness
3) to predict outcomes of cancer patients categorised by individual disease characteristics, demographics, socioeconomic factors and comorbidities
Our findings could better inform clinical practice guidelines on the management of cancer patients from diagnosis to treatment options and management of treatment side effects.This study aims to describe demographics, clinical characteristics and treatment/cancer care patterns, estimate treatment effects, and predict outcomes of patients of selected common cancers (breast, lung, colorectal, head and neck, brain, pancreas, uterine, and cervix) and subgroups of patients by individual disease characteristics, demographics, socioeconomic factors and comorbidities.
Objectives:
1. To characterise comorbidities, treatment patterns, and outcomes of patients with common cancers
2. To estimate the survival and side effects of treatment regimens of common cancers
3. To develop and validate risk stratification models to better predict progression in common cancers.
All analyses will be performed separately for each cancer site.We will include all patients with diagnosis of cancer or treatment of interest and conduct cohort studies using data mapped to the Observational and Medical Outcomes Partnerships Common Data Model.
Objective 1: Patient characteristics, comorbidities, treatment patterns, symptoms, survival of cancer of interest will be described. Clinical phenotyping of cancer patients will be tested and validated using large language models (LLMs).
Objective 2: Survival and adverse events from treatment regimens of cancer of interest will be described and compared using propensity score-matched/stratified/weighted Cox regression.
Objective 3: Prediction of progression of patients with cancer of interest using Cox regression and machine learning models.
For all objectives, the population with cancer diagnosis of interest will be selected using recorded diagnosis (between 01 January 2010 until latest available data) in National Cancer Registration and Analysis Service data. Treatment, covariates, and outcomes of interest will be identified using CPRD data and linkage to Hospital Episode Statistics for hospital procedures, NCRAS for cancer staging and Radiotherapy Data Set and Systemic Anti-Cancer Therapy data set for treatment and treatment outcomes.Our findings could better inform clinical practice guidelines on the management of cancer patients from diagnosis to treatment options and management of treatment side effects.
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ID-445: Protecting healthcare pathway and improving diagnostic and management of acute respiratory infections (ARI) — Imperial College London...
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ID-445: Protecting healthcare pathway and improving diagnostic and management of acute respiratory infections (ARI)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Acute Respiratory Infections.
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ID-458: Re-Defining Care for Patients with Advanced Heart Failure in North West London — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-458: Re-Defining Care for Patients with Advanced Heart Failure in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart failure. Commercial
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ID-168-4: Extension: Supporting early feasibility for non-commercial studies in North West London — ICHNT...
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ID-168-4: Extension: Supporting early feasibility for non-commercial studies in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: ICHNT
Description: early feasibility for non-commercial studies.
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ID-452-1: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy — Imperial College NHS Healthcare Trust...
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ID-452-1: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Family size.
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ID-460: #2035 Clinical indicators — Westminster City Council...
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ID-460: #2035 Clinical indicators
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: 2035.
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ID-219-6: Extension: Quality of secondary prevention following percutaneous coronary interventions in North West London — Royal Brompton & Harefield Hospitals NHS Trust...
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ID-219-6: Extension: Quality of secondary prevention following percutaneous coronary interventions in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: Royal Brompton & Harefield Hospitals NHS Trust
Description: Coronary Disease.
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ID-459: Comparative Data Health Data — Westminster City Council...
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ID-459: Comparative Data Health Data
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Sexual health JSNA.
Source
2025 - 03
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A real-world evaluation to describe the epidemiology, treatment and healthcare resource use in the management of bullous pemphigoid for adults — Christopher Morgan ...
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A real-world evaluation to describe the epidemiology, treatment and healthcare resource use in the management of bullous pemphigoid for adults
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-11
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Anastasia Petrova - Collaborator - Sanofi Aventis SA
Lisa SUTOUR - Collaborator - Sanofi US Services Inc (USA)
Marine Payan - Collaborator - Sanofi US Services Inc (USA)
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence; incidence; baseline characteristics; treatment pathways; health resource utilisation; healthcare costs; comorbidity; mortality; infection, fractures, obesity, pulmonary embolism, confusion, psychosis; depression.
Description: Lay Summary
Bullous pemphigoid (BP) is a rare skin condition that impacts the quality of life of older adults, causing painful, fluid-filled blisters and severe itching. Managing BP often requires significant healthcare resources, including medications, specialist care, and sometimes hospital stays. Understanding how BP patients are treated is important for improving care and supporting future treatment advancements. In this study, we will select patients with BP from the Clinical Practice Research Datalink (CPRD) database. We will describe how many people have been diagnosed with BP and how many are newly diagnosed with the condition each year. We will then describe the profile of these patients by age and gender, comorbidities, and current and previous medications. We will assess how often people with BP contact their general practitioner and are seen in hospital either as outpatients or inpatients. We also want to compare the rate of other health conditions and death in this population to controls, that is patients from the same general practice of the same age and gender who do not have BP. In addition, we will assess all these outcomes for patients categorized as having mild versus moderate/severe disease and based on their corticosteroid use. The findings will help us understand the challenges faced by patients with BP and how resources are currently being used to manage this condition. This information can guide doctors, healthcare planners, and researchers in finding ways to improve care for BP patients, such as developing new treatments or making healthcare systems more efficient.
Technical SummaryBullous pemphigoid (BP) is an autoimmune pruritic skin disease typically occurring in people aged over 60. This study will investigate BP using the UK Clinical Practice Research Datalink Aurum linked with Hospital Episode Statistics inpatient and outpatient data and Office for National Statistics (ONS) death registration data. The main objectives are to estimate BP incidence and prevalence, describe patient demographics, clinical characteristics and treatment pathways, assess healthcare resource use and associated costs, and evaluate mortality, infection, fractures, obesity, pulmonary embolism, confusion, psychosis and depression. The study population will comprise adults with a diagnosis of BP who are of CPRD acceptable quality and HES eligible. Incidence and prevalence rates will be provided for the period 2004-2022. Patients with a first diagnosis of BP between 01/01/2012 and 31/12/2018 will form the incident cohort and those previously diagnosed and registered on 01/01/201/8 the prevalent population. Controls will be selected as a) general age/gender/practice matched and b) propensity score matched accounting for factors such as baseline morbidity. Baseline characteristics will be summarised. Treatment pathways will be described and Kaplan-Meier curves used to designate time to therapies categorized into first, second, and third-line treatments. Healthcare utilisation rates and costs will be compared with controls using Poisson regression and Gamma distribution respectively. Rates of clinical outcomes and death will be assessed and compared to controls using Kaplan-Meier curves and Cox models adjusting for baseline covariates. Sensitivity analyses will repeat analyses to include case identification and follow-up in the pandemic period and to select a sub-cohort fulfilling additional criteria to mirror a clinical trial. In addition, outcomes will be compared between mild versus moderate/severe patients and patients corticosteroid use. This research aims to improve understanding of BP management in primary and secondary care settings and provide insights into healthcare burden and costs.
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A longitudinal study to examine the temporal relationships of traumatic brain injury to psychiatric disorders and epilepsy — Cynthia Wright Drakesmith ...
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A longitudinal study to examine the temporal relationships of traumatic brain injury to psychiatric disorders and epilepsy
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-19
Organisations:
Cynthia Wright Drakesmith - Chief Investigator - University of Oxford
Churl-Su Kwon - Corresponding Applicant - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Micheal McKenna - Collaborator - University of OxfordOutcomes:
Traumatic brain injury; Psychiatric comorbidities; Mortality; Treatment of Psychiatric Disorders; Risk of Developing PTE; Health Resource Utilization.
Description: Lay Summary
Post-traumatic epilepsy (PTE) is a serious condition that can develop after a traumatic brain injury (TBI). Many people with PTE also suffer from psychiatric disorders like anxiety and depression. Our research aims to understand how PTE influences the development of psychiatric disorders (and vice versa), the risk of early death in these individuals, and the impact of timely treatment for these disorders. This research will help us understand how psychiatric disorders and their treatments affect the development of PTE. We hope to improve patient care and outcomes for those who suffer from TBI.
Technical SummaryPost-traumatic epilepsy (PTE) is a significant complication following traumatic brain injury (TBI), often accompanied by psychiatric disorders. Understanding the temporal relationships and impacts of psychiatric disorders on PTE development, associated mortality and effects of treatment is crucial for improving outcomes in affected populations. This study will look between the years 1998 to most recent available data (2022) where patients with PTE will be compared to people with (1) people with epilepsy not resulting from TBI, (2) people with TBI without epilepsy, and (3) people with no TBI and no epilepsy. We will use descriptive statistics to assess baseline demographic characteristics and the distribution of each group in the study population. Proportions (%) with their respective 95% confidence intervals will be calculated. Chi-square and t-tests will be used to assess differences in demographic and clinical characteristics between subjects in each group. 95% confidence intervals for incidence will be calculated using an exact method for a Poisson distribution. To examine the temporal relationship of TBI to psychiatric disorders and epilepsy, premature mortality and relationship of PTE to treatment of psychiatric disorders, we will use Cox proportional hazard models and Kaplan-Meier curves to estimate survival probabilities over time.
This research has significant public health implications. By clarifying the interplay between TBI, psychiatric disorders, and PTE, the study will help identify high-risk populations and inform targeted prevention strategies. The findings may lead to improved screening, early intervention, and treatment approaches to mitigate the burden of PTE and associated psychiatric conditions. Additionally, understanding the effects of psychiatric treatment on PTE outcomes could shape clinical guidelines and healthcare policies, ultimately reducing premature mortality and enhancing quality of life for individuals affected by TBI-related epilepsy.
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Sex-specific effectiveness and safety of carvedilol compared to metoprolol in heart failure. — Sophie Bots ...
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Sex-specific effectiveness and safety of carvedilol compared to metoprolol in heart failure.
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-06
Organisations:
Sophie Bots - Chief Investigator - Utrecht Institute for Pharmaceutical Sciences
Patrick Souverein - Corresponding Applicant - Utrecht UniversityOutcomes:
Effectiveness outcomes of interest: heart failure hospitalisation; all-cause-mortality; treatment discontinuation
Safety outcomes of interest: hypotension; renal impairment; bradycardia
Description: Lay Summary
Healthcare problem
Women treated with heart medications have twice the risk of side effects compared with men. This is especially pressing for women with heart failure, because this condition predisposes them to side effects. Literature suggests that sex-specific treatment may reduce the risk of side effects, as they could be related to biological differences in how women's and men's bodies handle medications.Knowledge gap
Women have been underrepresented in heart failure trials, and many trials do not report their findings by sex. This makes it difficult to detect differences in the number and type of side effects women and men experience, and to understand why these differences occur.Aim of this proposal
We aim to compare the effectiveness and safety of two heart failure medications named metoprolol and carvedilol. Literature suggests women and men metabolise metoprolol differently, leading to a higher risk of side effects in women. However, this has not yet been proven. We will address this evidence gap using real-world data of patients who use heart medications in their everyday lives, ensuring women with heart failure are properly represented.Expected public health benefits
Technical Summary
Serious side effects from treatment can cause hospitalization or even death, greatly affecting a patient's life. Even milder side effects like nausea can cause patients to stop their treatment, which can worsen their condition over time. By tailoring treatment based on sex, we can reduce these risks, improving health for individuals and reducing the overall impact on society.Background
Although observational research suggests that women treated with cardiovascular medications have twice the risk of adverse drug events (ADEs) compared with men, this knowledge has yet to be incorporated in practice. Main barriers are the (perceived) low quality of the observational evidence compared to clinical trial data and the lack of relevant and easy-to-interpret benefit-harm comparisons for clinicians and patients.Aims/objectives
(1) Generate evidence to support clinicians and patients in tailoring medication choices to patient sex by directly comparing sex-specific safety and effectiveness between two beta-blockers with similar indication.Study population
Women and men with HF who receive either the exposure of interest (carvedilol) or the comparator medication (metoprolol)Primary exposure(s) and outcome(s)
Primary exposure is carvedilol, with metoprolol as the active comparator.
Primary outcomes are split into effectiveness (HF hospitalisation, all-cause mortality), and safety (hypotension, bradycardia) outcomes.Data sources
We will use CPRD Aurum, linked to Hospital Episode Statistics (HES) to determine HF diagnosis and hospitalisations.Study design and methods
We will follow the target trial emulation framework, using the active-comparator new-user design. Confounding will be addressed through propensity score methods. We will use Cox proportional hazard models for both effectiveness and safety outcomes.Intended public health benefit
Reducing the risk of ADEs by tailoring HF treatment to sex leads to better short- and long-term outcomes, which decreases disease burden both on the individual and the societal level
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Medication related risks of delirium hospital admissions in people with dementia using self-controlled case series analyses and exploration of the effects of truncated medical records — Kathryn Richardson ...
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Medication related risks of delirium hospital admissions in people with dementia using self-controlled case series analyses and exploration of the effects of truncated medical records
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-24
Organisations:
Kathryn Richardson - Chief Investigator - University of East Anglia
Kathryn Richardson - Corresponding Applicant - University of East Anglia
chris fox - Collaborator - University of Exeter
Helen Parretti - Collaborator - University of East Anglia
Irene Petersen - Collaborator - University College London ( UCL )
Katharina Mattishent - Collaborator - University of East Anglia
Mizanur Khondoker - Collaborator - University of East Anglia
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Primary: unplanned hospital admissions with delirium; Secondary: unplanned hospital admissions; leaving the GP practice; care home admission; mortality; new prescriptions of acetylcholinesterase inhibitors, antidepressants, overactive bladder medications, antipsychotics, benzodiazepines/z-drugs or strong opioids
Description: Lay Summary
It is uncertain whether taking certain medications can increase or decrease the risk of delirium in people with dementia (PwD). Delirium is when someone becomes more confused very quickly and is very serious. They may not know where they are or what time it is, have trouble paying attention, and feel more restless or sleepy than usual. Delirium is distressing, can lead to longer hospital stays, speed up memory loss, cause further health problems and sometimes death.
This study mainly aims to examine whether taking certain types of medicines affects the risk of delirium in PwD. We will also examine if the risk of getting delirium after taking a medicine is different for different people. This study will also describe how often PwD go to hospital with delirium and how often this leads to PwD having to move to a care or nursing home (transitions of care). As researchers generally do not have access to medical records across a patientâs entire lifespan, we will also explore whether these shorter records affect our delirium risk estimates.
Our study will contribute to improving the care PwD receive by better understanding which people with dementia are at greater risk of delirium. We will develop simple prescribing advice for health care professionals. This may reduce the risk of PwD developing delirium, potentially avoiding hospital admissions and delaying transitions of care.
Technical SummaryWe aim to examine whether certain medications are associated with unplanned hospital admissions with delirium in people with dementia (PwD), and whether truncated GP records impact risk estimates.
Our primary study population is patients with a previous diagnosis of dementia (in CPRD or Hospital Episode Statistics Admitted Patient Care [HES] data) or previous prescription for a cognitive enhancer, and have GP registration at any time since January 2010 in CPRD Aurum in England. A secondary analysis will also include people with dementia in CPRD GOLD in England.
Our primary outcome is unplanned hospital admissions with delirium recorded (in HES) since January 2010.
Medication exposures of interest are new prescribing episodes of (a) strongly anticholinergic antidepressants, (b) strongly anticholinergic overactive bladder medications, (c) strongly anticholinergic antipsychotics, (d) acetylcholinesterase inhibitors, (e) benzodiazepines, or (f) strong opioid transdermal patches.
Our primary study design is to use self-controlled case series to estimate incidence rate ratios (IRR) for medication exposure and the risk of delirium. We aim to reporting findings separately by men and women where possible, due to possible gender differences in delirium risk and vulnerability to anticholinergic medication effects.
We will also explore predictors of left- and right-truncated primary care records and explore the impact of the truncated records on the delirium risk estimates.
The intended public health benefits include a better understanding of which people with dementia are at greater risk of delirium, will allow health care professionals to monitor these patients more closely.
Our findings aim to impact prescribing guidelines and hence reduce the risk of delirium in people living with dementia. This will potentially reduce hospital admissions, delay transitions of care and reduce NHS costs.
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Prevalence, risk factors and healthcare use associated with multi-person morbidity of chronic health conditions in children and parents — Ruth Gilbert ...
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Prevalence, risk factors and healthcare use associated with multi-person morbidity of chronic health conditions in children and parents
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD GOLD Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-05
Organisations:
Ruth Gilbert - Chief Investigator - University College London ( UCL )
Shabeer Syed - Corresponding Applicant - University College London ( UCL )
Ania Zylbersztejn - Collaborator - University College London ( UCL )
Claire Powell - Collaborator - University College London ( UCL )
gene feder - Collaborator - University of Bristol
Jenny Wooman - Collaborator - University College London ( UCL )
Joachim Tan - Collaborator - University College London ( UCL )
Stephen Roderick - Collaborator - University College London ( UCL )
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
⢠Primary outcome: Multi-person morbidity (MPM), defined as two or more family members (mother and/or children) with at least one chronic health condition (CHC).
⢠Secondary outcomes: CHC recurrence/frequency; adverse childhood experiences (ACEs); birth outcomes; all-cause/cause-specific GP contacts, hospital admissions, A&E visits, outpatient visits; carer status (recorded/inferred); all-cause/cause-specific child/maternal mortality.
Outcomes will be examined per child (unit: child) and as a count of affected children per mother (unit: mother). CHCs will be identified using established indicators and algorithms (e.g., Hardelid et al., Global Burden of Disease, CALIBER, HDR UK Phenotype Library) and reflect outcomes with high public health importance.Description: Lay Summary
Many families in the UK face "multi-person morbidity," where multiple members â parents and children â live with chronic health problems simultaneously. This shared burden increases stress, potentially leading to financial difficulties and social isolation. Family members may reduce work or education to care for each other, with children sometimes taking on caring roles. One person's health issue can directly affect another family member's well-being and treatment. For example, a parent's untreated condition can hinder a child's progress, and vice-versa.
Although UK social care policies encourage a "think-family" approach (considering the needs of the whole family), multi-person morbidity remains understudied in healthcare. Current research often examines adults or children separately, overlooking the interconnectedness of families' health, social context, and adversity. This research gap limits our understanding of how common it is and how best to support these families. No specific clinical guidelines exist for addressing multi-person morbidity.
This study aims to use linked healthcare records of mothers and children to understand multi-person morbidity among families in England. First, we will improve a preliminary set of indicators for chronic health conditions, examining their relationship with other health presentations in mothers and children, potentially related to increased long-term burden. We will then examine how common multi-person morbidity is, risk factors (like adverse childhood experiences) and its long-term impact by analysing healthcare use and carer burden. The findings will help inform policy and practice, improving coordinated health and social care for vulnerable families, supporting a "think family" approach that addresses interconnected health needs.
Technical SummaryWe aim to examine the prevalence, risk factors, and family healthcare burden associated with multi-person morbidity (MPM) â defined as two or more individuals within a family having a chronic health condition (CHC) â among mothers and children in England. We will use a birth cohort from the CPRD mother-baby link (MBL), linked with Hospital Episode Statistics, Index of Multiple Deprivation, and ONS mortality records.
Aims:
1.Derive and validate CHC indicators: Given the high prevalence of recorded health conditions, we will refine and validate a set of chronic health condition (CHC) indicators of high public health importance for mothers and children, suitable for ascertaining multi-person morbidity (MPM). We will use supervised machine learning to select indicators strongly associated with increased chronicity (duration, condition-specific healthcare use) and individual burden/impact (e.g., coded/inferred difficulty with daily living).2.Epidemiology of MPM: Estimate temporal trends in the incidence of MPM among children (0-18 years) and their mothers using weighted and adjusted logistic and Poisson regression. Primary analysis will focus on CHC counts per mother (family unit), examining variations by sibling exposure (firstborn, any child). Secondary analysis will examine associations between risk factors (maternal/birth characteristics, lifestyle, socioeconomic status, adverse childhood experiences) and MPM within families using Poisson models.
3.Estimate health burden associated with MPM, including healthcare utilisation (all-cause/cause-specific admissions, A&E, outpatient, and GP contacts), carer status (child/parent, coded/inferred), and child/maternal mortality associated with MPM using Poisson models, relative to families without MPM.
This study will provide valuable epidemiological insights into the family burden and determinants of MPM to inform the development of targeted "think family" and "think carer" policies and interventions to support families with complex health, social, and care needs. We hope to highlight the importance of responding to the health of children, parents, and carers to promote healthier trajectories for the whole family.
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An investigation of the epidemiology of multiple long-term conditions in persons with diabetes: A retrospective cohort study using CPRD — Clare Gillies ...
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An investigation of the epidemiology of multiple long-term conditions in persons with diabetes: A retrospective cohort study using CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-24
Organisations:
Clare Gillies - Chief Investigator - University of Leicester
Sarah Nalir Hassen - Corresponding Applicant - University of Leicester
Cameron Razieh - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Lauren O'Mahoney - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
Cardiometabolic long-term conditions (including but not limited to cardiovascular disease, heart failure, stroke, myocardial infarction, coronary heart disease and hypertension) and renal long-term conditions (including but not limited to nephropathy and chronic kidney disease)
Description: Lay Summary
Diabetes is one of the most common and fastest-growing long-term illnesses worldwide, affecting millions of people. People with diabetes have a higher chance of developing other long-term health problems like heart and kidney disease. When someone has more than one long-term condition (LTC), it is called multiple long-term conditions (MLTCs), which can seriously affect their health and quality of life. Managing MLTCs requires a more complex approach to care.
Technical Summary
This project aims to improve understanding of MLTCs in people with diabetes using data from GP practices in the UK. It will compare how common heart and kidney diseases are in people with and without diabetes and how often new cases occur. The study will also examine the age at which people with diabetes develop these conditions and estimate their lifetime risk of getting them.
The findings will help healthcare workers provide better and more effective care for patients with diabetes.Diabetes Mellitus (DM) is a significant global health issue, with rising incidence rates worldwide. Advances in glycaemic control and improved management strategies have led to longer life expectancy in people with DM in the recent years. However, persistent hyperglycaemia has resulted in an increased risk of developing multiple long-term conditions (LTCs), especially those related to cardiometabolic and renal conditions. While multiple studies have been conducted to explore the prevalence of these LTCs in people living with DM, there still remains a gap in understanding the progression of LTCs following a diagnosis of DM, especially Type 1 Diabetes Mellitus (T1DM). Limited data exist on the order and rates of multiple long-term condition (MLTC) development, particularly those involving cardiometabolic and renal complications.
This project aims to address this knowledge gap by conducting a retrospective cohort study using the Clinical Practice Research Datalink (CPRD) to investigate the epidemiology of MLTCs in people with T1DM, Type 2 diabetes (T2DM) and no DM. The study population will include those who are 18 years or older, with data collected from 1st January 2000 onwards. The study will compare the prevalence of LTCs in people with diabetes to those without, focusing on cardiometabolic and renal LTCs. It will also assess the lifetime risk of developing these conditions and examine the age at which MLTCs are diagnosed. The results of this study could inform healthcare policy and practice by identifying high-risk individuals for early intervention, ultimately reducing the burden of MLTCs and improving long-term outcomes for people with DM.
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The analysis of multiple long term conditions: Patient Profiles, Trends, Health Outcomes, and Economic Burden — Mohammad Ali ...
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The analysis of multiple long term conditions: Patient Profiles, Trends, Health Outcomes, and Economic Burden
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-06
Organisations:
Mohammad Ali - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Cameron Razieh - Collaborator - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Harini Sathanapally - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Nathalie Conrad - Collaborator - KU Leuven University
Sharmin Shabnam - Collaborator - University of Leicester
Yogini V Chudasama - Collaborator - Leicester Diabetes CentreOutcomes:
1. Prevalence of the most common MLTC clusters, overall and demographic factors.
2. Time/Risk of cause-specific/all-cause hospitalisation and mortality and diagnosis of MLTC.
3. Deprescribing rates compared to guideline recommended treatments.
4. Health service utilisation including consultations with primary care and out of hours services, secondary care referrals and secondary care consultations.
5. Pharmacological treatments associated with benefits and adverse events.
6. Commonly recorded risk factors and their association to the development of MLTCs.
7. Determine the effect of SES and ethnicity and disease trajectories in MLTC and rates of outcomes such as hospitalisation and mortality.Description: Lay Summary
People with two or more long-term health conditions are associated with poorer quality of life and earlier death and are becoming increasingly common, particularly as people are living for longer. The current evidence suggests that one in four adults aged over 65 have more than one disease that affects them.
We will investigate different causes which may increase the risk of severe outcomes such being admitted to the hospital or dying in this group of people. These causes include: being significantly overweight, being frail and having certain symptoms. Frailty is where your body becomes more vulnerable to illness and poor health, leading to poorer outcomes, and is worse in people with more than one health condition. Although frailty is not a specific disease, people who are frail often have multiple long-term health conditions share key features such as being tired, unintentional weight loss and older age.
Using the clinical practice research datalink (CPRD), we aim to describe the patterns of having many diseases at the same time and their impact on health outcomes which include being hospitalised and dying. A specific focus will be on being overweight and being frail, comparing groups with and without more than one disease. We will also investigate other factors such as the multiple medications prescribed for people in this group and their impact on outcomes being hospitalised and dying. Finally, we are interested how the order of diagnosis of multiple long long-term conditions impacts the risk of these very same outcomes.
Technical SummaryBackground: Multiple long-term conditions (MLTC) negatively impact quality and quantity of life more than single diseases. Understanding disease clusters can enhance patient care, but current methods for grouping MLTC are inconsistent and depend on the outcomes studied. We will use simple counts and cluster analysis to identify common disease clusters in patients with two, three, and four or more conditions and estimate their association with hospitalisation and mortality using linked datasets. Additionally, we will examine the economic impact of MLTC compared to single disease presentations and how various patient, sociodemographic, and clinical factors influence these clusters and their outcomes.
Design: Retrospective cohort design.
Methods: In the populations aged 18 and over, the CPRD Aurum dataset will be used to identify patients with two or more long-term conditions. We will compare those with two or more conditions to those with one or less long-term health condition. The outcomes will be determined from the linked datasets: Hospital Episode Statistics (HES) and Office for National Statistics (ONS) death data. Using survival analysis, longitudinal mixed methods and machine/AI approaches, we will investigate patient (age, sex, ethnicity, socioeconomic status), anthropometric (blood pressure/body mass index (BMI i.e. patients with and without obesity), routine tests (blood results, spirometry), service level factors (consultations in primary care and secondary care), prevalence of chronic symptoms, frailty and how they relate to the outcomes associated with MLTC. Finally, we will conduct economic analyses of MLTC including cost-effectiveness and cost of illness.
Outcomes: We aim to identify how patient, sociodemographic, and clinical factors contribute to MLTC clusters and their outcomes, observe MLTC trends over time, and quantify the economic burden of different MLTC clusters. This information will be crucial for developing targeted public health interventions and informing health policy to improve population health.
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Incidence, Treatment, and Natural History of Lyme Disease in the United Kingdon: A Population-Based Cohort Study — Albert Prats Uribe ...
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Incidence, Treatment, and Natural History of Lyme Disease in the United Kingdon: A Population-Based Cohort Study
Datasets:GP data, Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-26
Organisations:
Albert Prats Uribe - Chief Investigator - University of Oxford
George Corby - Corresponding Applicant - University of Oxford
Anna Saura-Lazaro - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
Incidence rates, and trends in incidence (by year, and month), and baseline characteristics of individuals diagnosed with Lyme disease, or coded with suspected disease;
The absolute and relative frequencies of tests and measurements performed to individuals with first coded diagnosis of Lyme disease, or coded with suspected disease;
The absolute and relative frequencies of pre-coding, and post-coding symptoms and complications in individuals diagnosed with Lyme disease, or coded with suspected disease;
Exposure to pre-specified drugs, and sequences of drugs used in individuals, post first-coding with Lyme disease, or suspected disease.
The prevalence of people who have ever had Lyme disease.
Description: Lay Summary
Lyme disease is an infection caused by tick bites. It may involve a rash, and then a mixture of symptoms such as tiredness, muscle aches, fevers, skin problems, and rarely more complex conditions involving the nervous system. Unfortunately, because these symptoms are common in many diseases, it can be difficult to detect Lyme disease, and people infected may not be diagnosed for a long time â enabling the disease to get worse, whilst it isnât treated.
Some studies have shown Lyme disease is becoming more common, but only include data until 2016. These studies donât look at the characteristics of people with Lyme disease, or the symptoms they have with the disease, in as much detail as we would like to know about. Resultantly, NICE, a major UK government organisation that makes recommendations on how drugs are used by doctors, recommended in 2018 that further similar studies are done, on the âincidence, presenting features, management, and outcome of Lyme disease in the UKâ.
We want to use data from GP practices in the UK, to understand how common Lyme disease is, the conditions people with Lyme disease typically have, the symptoms people experience before and after first coded diagnosis, and the long term effects of disease.
This is important for doctors and nurses to better understand the typical characteristics, and symptoms, of people infected with Lyme disease. This may enable sooner recognition - and ultimately more effective treatment of disease, before the patient gets worse.
Technical SummaryNHS GP records provide a unique source of data which can be used for estimating the incidence and prevalence of health conditions, including Lyme disease. We aim to use CPRD data mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) to estimate the incidence of Lyme disease, to describe the treatments used for Lyme disease, and to characterise the symptoms experienced by patients before, and after first coded diagnosis. Describing patient characteristics, symptoms and current treatments of Lyme disease could detect shortcomings in current management, inform guidelines of clinical practice, and improve overall public health.
Design: Population-based cohort study
Population:
All individuals within the CPRD GOLD database will be initially eligible in the selection period which will be 01/01/2000 to end of data visibility. Individuals with >=365 days of prior history before first-coded diagnosis of the selected codes related to Lyme disease will be eligible, with sensitivity analyses using different prior history requirements.Variables:
- We will use diagnostic codes in OMOP-mapped data to create a cohort of individuals with Lyme disease, or suspected Lyme disease.
- Exposure to pre-specified list of treatments for Lyme disease.
- Development of one of a pre-specified list of complications related to Lyme diseaseAnalyses:
We will estimate incidence rates, from 2000-2024, and further compare by month of first-coded diagnosis. Analyses will be stratified by age, sex, ethnicity, region, and calendar month/year. The number and percentage of patients receiving each of a pre-specified list of treatments for their condition will be described per calendar year. Included individuals will be characterised at the time of first-coded diagnosis, in demographics, symptoms, comorbidities, and treatments. We will compare people with Lyme disease or suspected Lyme disease to a control age- and sex-matched 1:1 sample of people active in the database at the same time.
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A Post-Authorisation Safety Study (PASS) of Abrysvo (Respiratory Syncytial Virus Stabilised Prefusion Subunit Vaccine) in Immunocompromised, or Renally or Hepatically Impaired Adults Aged 60 Years and Older in a Real World Setting in Europe and UK — Debabrata Roy ...
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A Post-Authorisation Safety Study (PASS) of Abrysvo (Respiratory Syncytial Virus Stabilised Prefusion Subunit Vaccine) in Immunocompromised, or Renally or Hepatically Impaired Adults Aged 60 Years and Older in a Real World Setting in Europe and UK
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-03
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Taylor Aurelius - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Denise Morris - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research UnitOutcomes:
The primary outcomes for this study are Adverse Events of Special Interest, which include:
Acute disseminated encephalomyelitis
Diabetes mellitus type I
Guillain-Barré syndrome
Narcolepsy
Thrombocytopenia (idiopathic)
Thrombosis thrombocytopenia syndrome
Acute cardiovascular injury
Arrhythmia
Coronary artery disease
Heart failure
Microangiopathy
Myocarditis
Myocarditis and pericarditis
Pericarditis
Stress cardiomyopathy
Coagulation disorders: Disseminated intravascular coagulation, venous thromboembolism (pulmonary embolism, deep vein thrombosis), thrombotic microangiopathy, cerebral venous thrombosis, thrombotic thrombocytopenia syndrome, ischemic stroke, myocardial infarction, haemorrhage
Single organ cutaneous vasculitis
Thrombocytopenia with venous thromboembolism
Bellâs palsy
Generalised convulsion
Meningoencephalitis
Transverse myelitis
Acute respiratory distress syndrome
Erythema multiforme
Anaphylaxis
Death (any causes)Description: Lay Summary
In 2023, a new vaccine called Abrysvo and made by Pfizer, was approved in the United Kingdom (UK) and European Union (EU) to protect individuals 60 years of age and older against a lung infection caused by a virus called RSV (respiratory syncytial virus). In the UK, Abrysvo is being given to adults turning 75 years of age on or after 1 September 2024 plus a catch-up group of people who are aged 75-79 years on this date.
Results from a large global study suggest that this vaccine is safe in most older adults. However, further research is required to understand the safety of Abrysvo in older people who have weakened immune systems or those with kidney or liver problems. This is because these people were not included in previous studies.
This EU and UK study will look at the safety of Abrysvo in people aged 60 and older who have weakened immune systems or kidney or liver problems. It will compare the health outcomes of those who get the vaccine with those who do not. Characteristics such as age, medical conditions, and use of medications will also be considered in the study. The UK findings will be combined with results from similar studies in Spain and France to provide a clearer understanding of the safety of Abrysvo for older people with weakened immune systems or those with kidney or liver problems.
Technical SummaryThe Pfizer Abrysvo vaccine was approved for use in the European Union (EU) and United Kingdom (UK) in August and November 2023, respectively, to provide protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and over. In the UK, the vaccination campaign offers Abrysvo to adults turning 75 years of age on or after 1 September 2024, plus a catch-up group of people who were aged 75-79 years on this date. Initial data from the global RENOIR trial (C3671013, NCT05035212) has provided evidence for the safety of Abrysvo. However, immunocompromised and renally and hepatically impaired older adults were not included in this or other relevant clinical trials. In order to gain a more complete understanding of the safety of Abrysvo, safety monitoring of Abrysvo is required in the UK and EU in these patient groups.
The Vaccine monitoring Collaboration for Europe (VAC4EU), on behalf of Pfizer, are conducting this post-authorisation safety study across electronic health records databases from three countries, to fulfil regulatory requirements in the EU. This CPRD study forms the UK arm of the study. Aggregate results from CPRD analyses (with small cell counts masked as â<5â) will be pooled with results from the other contributing data sources (approval Query Reference number 00077310).
This retrospective comparative cohort study aims to determine the incidence of safety events of interest among immunocompromised, or renally or hepatically impaired adults aged 60 years and older who receive Abrysvo compared to a relevant comparator group who does not receive Abrysvo. Incidence will be compared between the two groups using a conditional Poisson regression model from which incidence rate ratios and 95% confidence intervals will be reported. If appropriate, based on the outcome of interest, the study will also use a self-controlled risk interval design.
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Retrospective evaluation of the epidemiology of interstitial lung disease in the UK: a population-based study — Chloe Bloom ...
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Retrospective evaluation of the epidemiology of interstitial lung disease in the UK: a population-based study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-11
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Bohee Lee - Collaborator - Imperial College London
Leda Yazbeck - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
Phil Molyneaux - Collaborator - Imperial College LondonOutcomes:
In our ILD cohort we will measure prevalence, healthcare utilisation including consultations and medications, symptoms, severity including exacerbations, hospitalisations, mortality and exacerbation risk factors, mortality and mortality risk factors. We will stratify by ILD conditions.
Description: Lay Summary
Interstitial lung disease (ILD) is a group of lung conditions caused by inflammation and often causes progressive scarring of the lungs. As part of this process, lung tissue thickens and stiffens, making it hard for the lungs to expand and fill with air, often leading to cough and progressive breathlessness and can cause premature death. ILD can have many causes, including long-term exposure to hazardous materials such as asbestos, some types of autoimmune diseases, such as rheumatoid arthritis, but the cause sometimes isn't known. One of the commonest of the ILD conditions is called idiopathic pulmonary fibrosis; the cause of this is unknown. Idiopathic pulmonary fibrosis affects over 32 000 people in the UK, accounting for around 1 in every 100 deaths each year. All the ILD conditions can gradually worsen over time but acute worsening of the condition, called an exacerbation, can expedite that progression. Exacerbations are episodes of worsening of symptoms, such as breathlessness, which come on gradually over a short period of time. Exacerbations often cause a rapid decline in the patientsâ lung function such that even after symptom recovery, the lungs do not return to pre-exacerbation level of function. There are several factors that have been suggested to cause exacerbations, these include infections, work exposures, pollution, gastric acid and medications. As ILD can be a devastating disease we want to get a better understanding of how common ILD is in the UK, who gets ILD and what happens over time to people with ILD.
Technical SummaryIn this study we aim to measure the prevalence of ILD, describe who gets ILD, how it is managed and obtain a better understanding of prognosis and the factors that cause disease progression.
To do this, we will draw a population of patients aged over 17 years old with interstitial lung disease (ILD) from the CPRD Gold and AURUM databases between 2004 and 2024. The outcomes will include prevalence of ILD, exacerbations, exacerbation risk factors, mortality and mortality risk factors. Outcomes will be determined using CPRD, Hospital Episodes Statistics and Office of National Statistics death registration data.
We will conduct a cohort design and describe the population, calculate prevalence, exacerbations and mortality, and run Cox regression models within the ILD cohort to determine effect estimates for risk factors. As a sensitivity analysis we will conduct a nested case control design. We will stratify by several factors including gender, age, types of ILD and exacerbation risk factors. Model covariates will include age, BMI, socioeconomic status, smoking status, alcohol consumption, medications, infections, vaccinations, the presence of other comorbidities such as gastroesophageal reflux, other respiratory diseases such as asthma, chronic obstructive pulmonary disease and bronchiectasis, diabetes and cardiovascular disease.
This study will improve the management of people with ILD and enable clinicians to provide more information to patients regarding their condition.
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Exploring healthcare pathways according to socioeconomic deprivation in populations with osteoarthritis: Applying sequence analysis to pre-arthroplasty pathways — Dahai Yu ...
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Exploring healthcare pathways according to socioeconomic deprivation in populations with osteoarthritis: Applying sequence analysis to pre-arthroplasty pathways
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-13
Organisations:
Dahai Yu - Chief Investigator - Keele University
Smitha Mathew - Corresponding Applicant - Keele University
Emma Parry - Collaborator - Keele University
George Peat - Collaborator - Sheffield Hallam University
James Bailey - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Martin Thomas - Collaborator - Keele UniversityOutcomes:
The prevalence of care strategies in the THR and TKR cohorts and the typologies of healthcare pathways in both most and less deprived groups within the THR and TKR cohorts.
Description: Lay Summary
Hip and knee osteoarthritis are the most common joint diseases. Various management options exist for these conditions, including non-surgical and surgical treatments. If the condition worsens, hip or knee replacement surgeries may be necessary, which is an effective solution. Before reaching that point, patients usually go through various types of care, like pain consultations, medication, physiotherapy, imaging, and specialist referrals. However, we lack a clear understanding of how patients actually receive care, specifically the timing and types of treatments they receive. This study examines the care pathway of patients who had hip or knee replacement surgery from 2007 to 2023. It also explores whether these care pathways differ between the most and less deprived areas. This study aims to find out where healthcare differs from national guidelines and to understand why it might differ, taking into account factors like age, gender, and socioeconomic status.
Technical SummaryHip and knee osteoarthritis are major causes of pain and disability worldwide, with treatment guidelines advocating a mix of non-pharmacological, pharmacological, and surgical approaches. Total hip replacement (THR) and total knee replacement (TKR) are recommended for patients with advanced conditions that significantly affect their daily activities. However, the patterns of care leading up to THR and TKR are not well-defined. Evidence suggests that there are inequalities in the provision of THR and TKR between most and least deprived areas in England. Nevertheless, it remains unclear whether the clinical pathways before THR or TKR differ based on socioeconomic status.This study aims to identify where healthcare differs from national guidelines and understand the reasons for these differences based on age, gender, and socioeconomic status. This study can inform policy changes, improve adherence to best practices, and promote equitable healthcare delivery.
This observational study aims to establish two retrospective cohorts comprising patients who have undergone THR/TKR surgeries due to osteoarthritis. In each cohort, most and less deprived sub-populations, according to the index of multiple deprivations, IMD (2019) English national ranking, will be 1:1 matched within the CPRD plus HES plus IMD linkage. The matching process will consider age group, sex, and index year. In our descriptive analysis, we will describe the prevalence of various care strategies in the 10 years leading up to the THR/TKR, using 12-month windows. A robust Conditional Poisson regression model will be used to calculate prevalence rate ratios for each care strategy within 12-month windows within the THR and TKR cohorts. Sequence analysis will be used to construct distinct typologies of healthcare pathways in most and less deprived groups within the THR and TKR cohorts and evaluate the correlation between care pathways and the covariates in the most and less deprived groups within the THR and TKR cohorts.
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Non-interventional retrospective cohort study of prevalence of diagnosed group 2 pulmonary hypertension in the UK — Julia DiBello ...
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Non-interventional retrospective cohort study of prevalence of diagnosed group 2 pulmonary hypertension in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-12
Organisations:
Julia DiBello - Chief Investigator - Merck & Co., Inc.
Julia DiBello - Corresponding Applicant - Merck & Co., Inc.
Alejandro Victores - Collaborator - Merck Sharp & Dohme LLC
Anna Watzker - Collaborator - Merck & Co., Inc.
Tammy Jiang - Collaborator - Merck & Co. Inc - Pennsylvania, USAOutcomes:
Prevalence of diagnosed PH-LHD; Clinical characteristics and co-morbidities of the diagnosed PH-LHD population; Frequency of use of LHD and PAH specific therapies in the diagnosed PH-LHD population; All-cause mortality proportion and rate in diagnosed PH-LHD population.
Description: Lay Summary
Pulmonary hypertension (PH) is a type of high blood pressure that affects the arteries in the lungs and can lead to progressive declines in the ability to carry out daily activities of interest and premature death. There are 5 different types or groups of PH with Group 2 PH being the most common form of the disease. Group 2 PH occurs in people with heart disease that affects the left side of their heart. Group 2 PH is likely underdiagnosed in real world practice because there are no treatments available for this disease. Additional population based epidemiologic studies are needed to understand the prevalence and diagnosis of this disease. Further understanding of this disease will help to determine potential diagnostic and therapeutic interventions to improve patient outcomes.
Technical SummaryThe primary objective of this retrospective cohort study is to estimate the annual prevalence of diagnosed pulmonary hypertension (PH) due to left heart disease (PH-LHD) in the United Kingdom (UK) overall and by underlying left heart disease (LHD) etiology. Pulmonary hypertension and LHD will be identified based upon READ and International Classification of Disease 10 (ICD-10) codes available in the Clinical Practice Research Datalink (CPRD) and the Hospital Episode Statistics data (HES); code lists will be based upon the published literature and expert clinical input from a cardiologist practicing in the UK. No previous studies have utilized CPRD or HES data to study PH-LHD. It is unknown whether PH-LHD cases are diagnosed at PH specialty centers in the UK located within outpatient clinics of National Health Service (NHS) hospitals or if they receive their diagnoses within community specialty settings (e.g. cardiologist office). Given the uncertainty regarding the number of PH-LHD patients receiving a diagnosis within a hospital setting and therefore the number of diagnoses that will be present in the HES data, a feasibility assessment will be conducted examining the proportion of PH-LHD cases with diagnoses in CPRD and in HES. If a relatively small proportion of cases have diagnosis codes in HES, the study may be conducted using only the CPRD data to maximize the sample size available for the study. Annual prevalence will be calculated by dividing the number of individuals with PH-LHD in 2019 and 2023, by the number of patients alive and registered in the study data set on December 31, 2019 and December 31st, 2023, respectively. Associated 95% confidence intervals will be calculated using the Clopper-Pearson Method. This study will improve public health policy as an understanding of the diagnostic pathway for a contemporary PH-LHD cohort will help in the design of public health interventions.
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Epidemiology, treatment patterns and burden of illness associated with hypertrophic cardiomyopathy with a focus on the non-obstructive sub-type in England. — Michael Hurst ...
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Epidemiology, treatment patterns and burden of illness associated with hypertrophic cardiomyopathy with a focus on the non-obstructive sub-type in England.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-20
Organisations:
Michael Hurst - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Amrinder Malhi - Corresponding Applicant - Bristol Myers Squibb - Europe ( BMS )
Belinda Sandler - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Clement Acheampong - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Florence BRELLIER - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Jason Dungu - Collaborator - Mid and South Essex NHS Foundation Trust
Mansi Goyal - Collaborator - Mu SIgma
Maryam Jetha - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Stella Han - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Tejas Gade - Collaborator - Mu SIgma
Yue Zhong - Collaborator - Bristol-Myers Squibb - USA ( BMS )Outcomes:
Primary (HCM cohort; non-obstructive HCM cohort; obstructive HCM cohort):
1. Epidemiology: Prevalence and incidence rates
2. Patient/clinical characteristics: Patient/clinical characteristics (including family history), history of comorbidities, socio-demographic factorsSecondary (obstructive HCM cohort only):
1. Natural history: Proportions and incidence rates and time to event analyses
2. Treatment pathways: Incidence rates, time to event, time on treatment, adherence measures
3. Economic burden: Proportions and incidence rates with events. Medical costs.Exploratory: As per primary/secondary aims
Subgroup analyses: As per primary/secondary aims including linear regression models.
Description: Lay Summary
Hypertrophic cardiomyopathy (HCM) is the most common type of cardiomyopathy, often inherited, and is characterised by the thickening of the heart muscle, especially in the left ventricle. HCM can be divided into two types: obstructive and non-obstructive, based on whether there is a blockage in the left ventricular outflow tract (LVOT), which is the path through which blood flows from the heart. According to the guidelines from the American Heart Association (AHA) and the European Society of Cardiology (ESC), obstruction is considered significant if the pressure gradient in the LVOT is 30 mmHg or higher at rest, or more than 50 mmHg with exercise.
Technical Summary
For patients with non-obstructive HCM, the disease usually leads to troublesome symptoms such as shortness of breath, chest pain, and fainting. Currently, available treatments for non-obstructive HCM mainly focus on relieving these symptoms rather than addressing the root cause of the disease. If the condition progresses to heart failure, patients may need more advanced treatments, such as a heart transplant or a left ventricular assist device (LVAD).
This study aims to expand our understanding of the real-life impact and unmet needs of patients with non-obstructive HCM. Specifically, we want to explore the number of people affected by the condition in England, the characteristics of these patients, their treatment histories, how the disease progresses over time, and the healthcare resources and costs involved in their care.This is a retrospective observational cohort study describing the real-world epidemiology, patient characteristics, treatment history and treatment patterns, natural history, health care resource utilisation, and medical cost of patients diagnosed with non-obstructive HCM in England between January , 2001, and March, 2023.
Utilising linked CPRD (Aurum) and HES databases, patients with HCM (via ICD-10 codes) will be extracted with inclusion and exclusion criteria applied to define both a cohort of patients diagnosed with non-obstructive HCM and obstructive-HCM.
The study will primarily be descriptive in nature. The primary aims of the study are to assess the prevalence and incidence of HCM and to summarise the patient and clinical characteristics. Secondary aims will outline treatment/care pathways, the natural history of disease through time to event analyses, and will describe healthcare resource utilisation. Hypothesis generating comparative analyses will assess whether both patient (such as age/sex) and clinical factors (such as symptomatic status, presence of interventions, or diagnostic events) impact each of the outcomes studied.
Baseline patient/clinical characteristics and incidence/prevalence rates (i.e. primary aims) will be performed on both the non-obstructive cohort, as well as the obstructive and the combined HCM cohort. Natural history, treatment patterns/sequencing and healthcare resource utilisation (HCRU) will be performed on the non-obstructive HCM cohort only.
Exploratory analyses will look at the impact of the adoption of a NYHA classification algorithm (developed and revised by Key Opinion Leaders (KOLs) for a non-obstructive cohort), and a sensitivity analysis redefining the inclusion criteria for the non-obstructive HCM cohort. This research will help address the unmet need in this patient population and understand where interventions may be of benefit.
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Real world utilisation of oral semaglutide and association with HbA1c in primary care clinical practice in the United Kingdom — Christopher Morgan ...
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Real world utilisation of oral semaglutide and association with HbA1c in primary care clinical practice in the United Kingdom
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-26
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Edward Collins - Collaborator - Novo Nordisk Ltd
Jonathan Patrick - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Margherita Bortolini - Collaborator - Novo Nordisk LtdOutcomes:
Change in HbA1c from baseline; change in body weight from baseline; proportion of patients achieving HbA1c <53mmol/mol, (<7.0%); change in cardiovascular and renal markers from baseline (systolic blood pressure, diastolic blood pressure, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, estimated glomerular filtration rate); gastrointestinal side effects (nausea, vomiting, diarrhoea or constipation); therapy discontinuation.
Description: Lay Summary
Type 2 diabetes (T2DM) is a common disease affecting approximately 5% of the UK population and that is likely to increase over the coming years. The NHS currently spends an estimated £10 billion on diabetes care per year with a large proportion of this budget spent on treating diabetic complications. These complications include heart attacks, strokes, amputations, sexual problems, eye disease, nerve damage and kidney disease. T2DM is also associated with premature mortality. Early, effective treatment of T2DM can reduce some of these complications. Research has shown that interventions which lead to weight loss can reduce disease severity and reduce the risk of developing T2DM. Oral semaglutide has been developed to treat T2DM and has been shown in clinical trials to reduce blood sugars and induce weight loss in people living with T2DM. However, very little is known about its effectiveness in everyday clinical practice in the UK where it is typically prescribed by general practitioners. This study aims to determine whether oral semaglutide use in real-world clinical practice has meaningful effects on blood sugars and weight. To do this we will use the Clinical Practice Research Datalink Aurum and GOLD databases and compare the blood sugar and weight of patients before and after they start treatment with semaglutide tablets. Additionally, it will look at whether these effects are greater in people with T2DM who start treatment with higher blood sugars and/or weight. This will provide useful information to improve patients health and potentially provide savings to health service budgets.
Technical SummaryOral semaglutide is the first glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed for oral administration for the treatment of type 2 diabetes mellitus (T2DM) and is available on prescription in the UK. The efficacy and safety of oral semaglutide were demonstrated in the PIONEER programme of 10 phase 3a randomized controlled trials, which included more than 9,500 patients. In this study we wish to use the Clinical Practice Research Datalink Aurum and GOLD databases together with Office of National Statistics Index of Multiple Deprivation data to assess the efficacy and safety profile of oral semaglutide in real-world clinical practice. The study period will be from 01/09/2020 to last available data. T2DM patients, naïve to oral semaglutide, initiating treatment with either 3mg, 7mg or 14mg semaglutide tablets will form the study population. Date of first prescription will be the index date. The primary endpoints will be change in HbA1c between baseline (90 days prior to index date) and two checkpoints: 180 (± 30) days and 365 (± 30) days following index date. Secondary endpoints will include change in weight at the two checkpoints, the proportion of patients achieving HbA1c <53mmol/mol (<7.0%), change in additional cardiovascular makers, therapy discontinuation and incidence of gastro-intestinal adverse events. Mean, standard deviation, median and interquartile range of continuous variables will be provided. Categorical measurements will be presented with percentages. Comparison of before and after measurements will use the paired t-test or non-parametric equivalent depending on the distribution. Analyses will be replicated for sub-groups based on categories of baseline HbA1c, baseline BMI, ethnicity and concomitant anti-diabetic therapy. Evaluating how observations from clinical trials translate into real world clinical practice will inform the role of oral semaglutide in T2DM management with potential benefits both for the individual patient and long term cost savings for health services.
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Clinical indications and prescribing patterns of corticosteroids in England — Jennifer Quint ...
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Clinical indications and prescribing patterns of corticosteroids in England
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-11
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College LondonOutcomes:
1) Disease systems
2) Disease indications
3) Mean equivalent steroid potency.
4) Route of administration
5) Length of time on prescriptionDescription: Lay Summary
Steroids are medicines used to treat long-term illnesses like asthma, eczema, and inflammatory bowel disease. They come in different forms, such as pills, creams, injections, or inhalers. Steroids can be very helpful to reduce inflammation in the body. But if people take them for a long time, even at low doses or for a short time at high doses, they can also lead to other health issues. These include weight gain, heart problems, diabetes, and even mental health struggles.
For some conditions, people might still get the benefits they need using a lower dose or shorter duration of steroids. In addition, people may have more than one condition in which they need steroids, thus increasing their use. Or there are other medicines that could be used instead of steroids. By using these options sooner, it could help prevent the extra health problems that steroids cause. However, before we can look into this in more detail, we need to determine what disease areas and specific conditions are commonly prescribed steroids and what the average dose, route of administration, and length of time on steroids are to contextualise steroid use in England.
Technical SummaryCorticosteroids are commonly used in the management of a range of inflammatory conditions. Corticosteroids are frequently used to manage symptoms and reduce disease progression in chronic inflammatory and autoimmune diseases. This often involves managing multiple diseases with multiple treatments and multiple corticosteroid prescriptions. Evidence suggests that steroids can be harmful if they are overused and could lead to steroid-resistance in patients as well as life-threatening withdrawal reactions. In certain conditions, patients may achieve therapeutic benefits with a reduced steroid dosage or a shorter treatment duration. Alternatively, other treatments may be a suitable replacement for steroids. Implementing these alternative treatment strategies early in the management process could reduce the risk of steroid-related adverse effects and associated complications.â¯With increasing numbers of corticosteroid-sparing treatments now available for specific conditions, we now need up-to-date evidence about the utilisation of corticosteroids.
To do this we aim to describe the use of steroids in England in a given year. We will use CPRD Aurum to define a population of people with at least one steroid prescription in 2023 and we will describe: 1) the associated disease systems, 2) the associated disease indications by disease system, 3) the average dose by disease system, 4) the routes of administration of steroids by disease system, and 5) the length of time prescribed a steroid over the year of follow-up by disease system. We will use frequencies (%), means (standard deviation) or medians (interquartile range) to address our objectives. This work will inform a larger programme of work looking at how steroids are used and the health issues that they can cause to create a digital decision-making tool to determine patients who might be at risk of harm from steroids and suggest alternative treatment approaches.
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Montelukast and Neuropsychiatric Events: A target trial emulation to quantify adverse reactions and measure the impact of regulatory action — Ian Douglas ...
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Montelukast and Neuropsychiatric Events: A target trial emulation to quantify adverse reactions and measure the impact of regulatory action
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-18
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Alex Lyons - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anna Schultze - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Craig Allen - Collaborator - MHRA
Jennifer Quint - Collaborator - Imperial College London
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Lysette Moses - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Neuropsychiatric outcomes will comprise:
-sleep disorders (night terrors, dream abnormalities, nightmares, insomnia, somnambulism)
-anxiety
-depression (including psychotic depression)
-schizophrenia spectrum disorders (including schizoaffective disorder)
-bipolar disorder
-personality disorders
-social/emotional/behavioural and conduct problems in childhood (including conduct disorders, mixed disorder of conduct and emotions, reactive attachment disorder, non-organic enuresis and aggression).
-suicidal ideation, suicide attempts and suicide
-self-harm
-obsessive/compulsive behaviour (OCD)
-ADHD and
-autism.Description: Lay Summary
Montelukast is a medicine. It is commonly used in the UK to treat asthma and has been for the last 25 years.
All medicines can cause side-effects. These can include problems such as anxiety, depression, sleep problems and suicidal thoughts. Doctors call these types of side-effects neuropsychiatric side-effects. Some people taking montelukast have had these problems. The UK medicines regulator has tried to warn doctors about this. It is unclear though, how often these side-effects occur, or how much doctors know about them. If people taking montelukast get neuropsychiatric problems and doctors do not know montelukast might be the cause, patients could continue taking it when it might be better to stop.After listening to the stories of families affected by montelukast side-effects, this research was planned.
UK de-identified electronic patient records are commonly used to research medicines and will be used in this study. Records from half a million people with asthma taking montelukast will be compared to records from similar people with asthma taking other asthma medicines.
This research will find out how often montelukast is used. It will look at how common neuropsychiatric side-effects are, and if doctors stop prescribing montelukast if they happen. The study will also see if doctors have changed the way they prescribe montelukast over time. This will help us understand whether warnings to doctors from the regulator about side-effects have worked, or if further action is needed.This research will help make sure that montelukast is used in the safest possible way.
Technical SummaryMontelukast, is a leukotriene receptor antagonist (LTRA) licensed to treat asthma, seasonal allergic rhinitis and chronic urticaria. It has been prescribed for asthma since 1998 to those aged >6 months. The Summary of Product Characteristics (SmPc) contains special warnings regarding neuropsychiatric side-effects [1]. However, the link between montelukast and these side-effects is not universally recognised by healthcare professionals, despite MHRA warnings in 2019 and 2024 [2-5].
Uncertainty remains regarding: the frequency of neuropsychiatric side-effects, whether the association is causal for some outcomes, frequency of treatment termination if side-effects are reported, and whether MHRA warnings have been impactful. This study aims to address these uncertainties.
The key study objectives with respect to montelukast are to:
-describe prescribing patterns in the last decade
-measure absolute rates and relative hazards of neuropsychiatric symptoms amongst users compared to similar patients starting active comparators
-quantify treatment termination frequency for those with neuropsychiatric symptoms
-generate a risk prediction model for neuropsychiatric symptoms.The study population will comprise people in England attending NHS primary care centres with moderate/severe asthma of sufficient severity for montelukast initiation to be considered (based on Global Initiative for Asthma (GINA) score) [6].
The primary exposure will be montelukast prescription for asthma.
Study outcomes will comprise: sleep disorders, anxiety, depression, psychotic disorders, personality disorders, social/emotional/behavioural/conduct problems of childhood, self-harm, suicide, obsessive/compulsive behaviour (OCD), ADHD and autism.
CPRD Aurum data will be linked to ONS death, area and HES APC data.
This target trial emulation will match similar asthma patients prescribed montelukast with those prescribed active comparators between 01/01/2015 and 31/12/2024 on demographic factors, calendar time and asthma severity. Propensity scores and inverse probability of treatment weights will help to quantify causal associations.
This research will fill knowledge gaps regarding the safe use of montelukast crucial to stakeholders and of importance to regulators.
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Understanding the patient characteristics and disease burden of influenza, and COVID-19 in the adult population in England using primary and secondary care data: a descriptive study — Heather Davies ...
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Understanding the patient characteristics and disease burden of influenza, and COVID-19 in the adult population in England using primary and secondary care data: a descriptive study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-12
Organisations:
Heather Davies - Chief Investigator - York Health Economics Consortium Ltd ( YHEC )
Neil Hansell - Corresponding Applicant - York Health Economics Consortium Ltd ( YHEC )
Aaron Situ - Collaborator - Moderna Tx
Erin Barker - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Harriet Fewster - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Jamie Bainbridge - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Mihaela Georgieva - Collaborator - Moderna Tx
Mihir Desai - Collaborator - Moderna Tx
Orsolya Sebestyen-Balogh - Collaborator - Moderna Biotech Distributor UK Ltd
Reagan Davis - Collaborator - York Health Economics Consortium Ltd ( YHEC )Outcomes:
The outcomes to be measured are as follows:
Patient characteristics; primary healthcare appointments; prescriptions; hospitalisations; hospitalisations in critical care; inpatient length of stay; inpatient procedures; source of admission; discharge status; outpatient appointments; outpatient procedures; rate of mortality (all-cause and disease-specific).
Description: Lay Summary
Influenza and COVID-19 are respiratory infections caused by viruses. They affect many people across England. They have a big impact on Englandâs healthcare system, particularly during the autumn and winter period. Research on the healthcare burden of influenza and COVID-19 remains a continued high priority, especially in light of ongoing discussion regarding the population at risk of contracting these viruses and those eligible for vaccination for them.
The aim of this study is to estimate healthcare resource use (such as the number of healthcare appointments, prescriptions and hospitalisations) and death rates associated with each of the viral infections as well as coinfections (i.e. people with both infections at the same time). This study is expected to improve public health outcomes, by providing insight into the current financial cost of influenza and COVID-19, healthcare usage and populations at risk for these respiratory infections in England.
Technical SummaryInfluenza and COVID-19 infection cause a substantial economic burden to the English healthcare system. This study aims to estimate the healthcare resource use (HCRU) and mortality associated with COVID-19 and influenza separately, as well as for a coinfections subgroup (i.e. people with both infections simultaneously). The study is a retrospective, descriptive study. The study population will be adults (aged ⥠18 years) with a recorded diagnosis of COVID-19 or influenza in primary care or during hospitalisation between 01 September 2021 and 31 March 2023 with a 1-year look back to identify risk groups. The Clinical Practice Research Datalink (CPRD) will be used to determine the HCRU in primary care, including general practitioner (GP) appointments and prescriptions. The Hospital Episode Statistics (HES) data will be used to determine the HCRU in secondary care, including hospitalisations, procedures and outpatient appointments. The Office for National Statistics (ONS) Death Registration will be used to determine overall mortality. The pregnancy register will be used to determine infections that occur during pregnancy. All outcomes will be assessed 28 days from the first diagnosis code (i.e. index date). Sensitivity analysis for the COVID-19 cohort only will assess outcomes at 90 days from index date. All analyses will be descriptive in nature. There will be no statistical comparisons between groups. Continuous variables will be summarised using mean and standard deviation or median and interquartile range. Categorical variables will be summarized using frequency counts and percentages. Missing data will be described using frequency counts and percentages. The expected public health benefit from this study is that it will provide insight into the current economic burden of respiratory diseases and ultimately improve patient care for patients with these respiratory infections.
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Place of death in people with pulmonary fibrosis in the England: A cohort study — Jennifer Quint ...
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Place of death in people with pulmonary fibrosis in the England: A cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-10
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Gisli Jenkins - Collaborator - Imperial College London
Joanna Porter - Collaborator - University College London ( UCL )
Rachel Chambers - Collaborator - University College London ( UCL )
Vidya Navaratnam - Collaborator - Imperial College LondonOutcomes:
1) Proportion of people with pulmonary fibrosis (PF) who die in hospital / home / community and changes over time.
2) Factors associated with death in hospital (vs hospice/home/community).Description: Lay Summary
Pulmonary fibrosis (PF) is a group of chronic lung diseases characterised by scar tissue within the lungs. Most people with this disease complain of difficulty breathing, cough, tiredness and unexplained weight loss. PF is a life-limiting condition with a worse outlook than certain cancers and an average survival of 3 to 5 years. Although there are now drugs available for PF, none reverse or cure the scar tissue already in the lungs. Lung transplantation remains the only cure for this group of patients.
Technical Summary
Access to end-of-life care or palliative care services in PF has been shown to be limited compared with patients with cancer. To date, there have not been any large studies looking at where patients with PF die (e.g. hospital or home) or what factors influences someone dying in hospital.
By using routinely collected health information from GP records linked to information collected from death certificates, we will estimate the proportion of people with PF who die in hospital, determine if the proportion of people with PF dying in hospital has changed over time and look at factors that influence dying in hospital.
We hope that this study helps us better understand end-of-life care in people with PF so that we can improve care to these group.The incidence of pulmonary fibrosis (PF), particularly idiopathic pulmonary fibrosis (IPF) is increasing in the UK and worldwide. Despite the introduction of anti-fibrotic therapy that has been shown to slow down disease progression, median survival in this group of patients remains unchanged and is similar to some cancers. Lung transplantation remains the only curative option for people with PF and is restricted to only a small proportion of patients. Despite PF being a terminal illness with a worse prognosis compared with bowel or bladder cancer, a recent study showed that only 20% of these patients are referred to palliative care services in the UK. To date, there are no large epidemiological studies investigating the proportion of patients with PF who die in hospital and what factors predict death in an acute hospital bed, with only findings from small single centre studies suggesting that a high proportion die in hospital.
In addition to the above, people with PF also experience high symptom burden (e.g. cough and breathlessness) which significantly impairs quality of life. There is emerging evidence that early palliative care involvement reduces symptom morbidity, improves quality of life and increases engagement with advanced care planning, especially with regards to where patients which to spend their last days of life.
Using CPRD Aurum data linked to ONS death registration data, HES Admitted Patient Care (APC) data and Patient level Index of Multiple Deprivation (IMD), we will calculate the proportion of PF patients who die in hospital, home/hospice, community facilities (residential/nursing home) year on year over between 1st of January 2008 and 31st of December 2019. We will also describe changes in trends in place of death over time. We will also determine characteristics (e.g. age, sex, ethnicity, socioeconomic status) that predict death in an acute hospital bed.
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Feasibility Study on the Frequency of BMI Measurements in CPRD Data to Assess Long-Term Health Impact of Overweight and Obesity — Emily Wilkes ...
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Feasibility Study on the Frequency of BMI Measurements in CPRD Data to Assess Long-Term Health Impact of Overweight and Obesity
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-11
Organisations:
Emily Wilkes - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Emily Wilkes - Corresponding Applicant - Eli Lilly and Company Ltd. (UK)
LUCY MITCHELL - Collaborator - Eli Lilly and Company Ltd. (UK)Outcomes:
Body Mass Index (BMI); Age at time of BMI measurement
Description: Lay Summary
Overweight and obesity are conditions which are characterised by excessive fat accumulation that can vary over time and presents a risk to health. A government survey conducted between 2022 and 2023 showed that 64% of people aged 18 or over in England are people with overweight or obesity, while 24% of people aged 18 or over in England are people with obesity. Further research has shown that the average healthcare cost of a person rises with increasing body mass index (BMI: a measure of body fat).
Technical Summary
Research shows that when BMI is measured only at one time-point, people measured to have a BMI indicative of overweight or obese have worse health compared to people who are not overweight or obese at a single time-point. However, less is understood about how a personâs lifetime exposure to overweight and obesity can impact health long-term. Understanding the long-term impact of obesity is important for improving healthcare planning and patient care.
The aim of this feasibility study is to assess how often BMI measurements are recorded for people of different ages within CPRD data. These feasibility findings will inform a future study to investigate the impact of overweight and obesity over an individualâs lifetime, and how this affects their long-term health and use of healthcare services. If successful, that study could help inform obesity prevention and treatment strategies. The future study will require that we can observe enough BMI records to measure the change in their BMI over a time-period.Background: There is limited evidence assessing the impact of BMI, as a measure of overweight and obesity, over the life-course. Research is required to understand the association of obesity duration and severity with adverse health outcomes and healthcare resource utilisation (HCRU).
Aim: The aim of this feasibility study is to describe the frequency over time of Body Mass Index (BMI) measurements among three age defined cohorts starting between the ages of: i) 10-12 years; ii) 23-25 years; and iii) 38-40 years.
Objectives: Among the three age defined cohorts, to: i) describe the count of individuals who have an indexing BMI measurement; and ii) assess the distribution of subsequent BMI measurements.
Methods: Retrospective cohort analysis of longitudinal BMI data in England using primary care data from Clinical Practice Research Datalink (CPRD) Aurum.
Index criteria: The first BMI measure within the index period (1st January 2004 to 31st March 2019) within the age ranges: i) 10-12 years; ii) 23-25 years; and iii) 38-40 years.
Outcomes: BMI values and patient counts.
Data analysis: All analysis will be descriptive in nature with counts, means, medians, standard deviation (SD), 25th and 75th percentile values to be reported. The distribution of BMI recording within each cohort will be assessed by describing the attrition of patient counts with BMI records in pre-defined age ranges following index. BMI values will be summarised descriptively, and histograms will be produced to illustrate the distribution of BMI values recorded at pre-defined age ranges.
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Factors associated with healthcare resource utilisation in endometriosis: a retrospective cohort study of electronic medical records in England — Emily Herrett ...
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Factors associated with healthcare resource utilisation in endometriosis: a retrospective cohort study of electronic medical records in England
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-11
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elke Rottier - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Georgie Massen - Collaborator - Imperial College LondonOutcomes:
The HCRU to be reported in this study includes hospital admissions, primary care consultations (all-cause and endometriosis-related), endometriosis-related prescriptions, and specialist referrals.
Description: Lay Summary
Endometriosis is a common inflammatory condition where cells like those in the uterus are found elsewhere. Around 1 in 10 females who have menstrual periods also have endometriosis. Symptoms vary between females and can include unusual bleeding, pelvic pain, sickness, and infertility.
The road to endometriosis diagnosis is long in England, with only a few specialist centres in the country. Females with endometriosis speak to many medical professionals before receiving a diagnosis. As well, treatment options after diagnosis are limited. Seeking help for symptoms is emotionally and physically burdensome for females, as well as symptoms themselves affecting ability to perform day-to-day tasks. The number and type of healthcare events females have before and after diagnosis are not well known in England.
This study will improve understanding of healthcare use in endometriosis, the link between factors and healthcare use, and the link between healthcare use before and after diagnosis. Findings will benefit people with endometriosis by improving understanding of the condition and how diagnosis and management are associated with healthcare use.
Technical SummaryAim: To improve understanding of healthcare resource utilisation (HCRU) in endometriosis and hence improve understanding of burden of disease. Findings will benefit people with endometriosis by improving understanding of the condition, typical HCRU, and risk factors of high HCRU.
Objectives: To 1) describe HCRU in primary and secondary care before and after endometriosis diagnosis using all available data, 2) identify baseline sociodemographic and clinical characteristics associated with HCRU in the 1-year prior to endometriosis diagnosis, 3) examine the relationship between HCRU in the 1-year prior to endometriosis diagnosis versus 1-year after.
Methods: A retrospective cohort study using data from the CPRD Aurum linked to HES APC and practice-level 2019 IMD. Females will be indexed into the study on the earliest observed endometriosis code. The index period will be from 01 April 2012 to 31 March 2022 based on available data. As CPRD Aurum and HES APC do not cover private healthcare events, this study population will constitute females with an observed diagnosis in an NHS setting only.
Data analysis: Objective 1 will be descriptive. Objectives 2 and 3 will be analytical using multinomial logistic regressions and will be adjusted using a minimum sufficient adjustment set to remove observed confounding. For objective 2, analytic comparisons of HCRU prior to diagnosis (outcome) will be made for each baseline characteristic one-by-one (exposure), after adjusting for the minimum sufficient adjustment set. For objective 3, the relationship between HCRU before (exposure) and after diagnosis (outcome) will be outputted, after adjusting for the minimum sufficient adjustment.
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Association between white blood cell counts and risk and severity of infections in individuals with cardiometabolic disease: An observational cohort study — Alice Carter...
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Association between white blood cell counts and risk and severity of infections in individuals with cardiometabolic disease: An observational cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-28
Organisations:
Alice Carter-Jones - Chief Investigator - Novo Nordisk A/S
Alice Carter-Jones - Corresponding Applicant - Novo Nordisk A/S
Harriet Larvin - Collaborator - Novo Nordisk Ltd
Klaus Andersen - Collaborator - Novo Nordisk A/S
Samuel Bennett - Collaborator - Novo Nordisk A/S
Suvi Hokkanen - Collaborator - Novo Nordisk A/SOutcomes:
We will study a range of infection outcomes, capturing type and severity of infection.
Primary outcome: diagnosis of infection from primary and secondary care EHR (ICD and SNOMED codes)
Secondary outcomes: type of infection (primary and secondary care; ICD and SNOMED codes); medications prescribed to treat infections (primary care; SNOMED codes); diagnosis of infection in hospital (secondary care; ICD codes); death with infection as primary or contributing cause (mortality records; ICD codes)
Infections cover diagnoses relating to lower respiratory tract infections, gastrointestinal infections, viral infections, sepsis, urinary tract infection, skin infections, bacterial infection, pneumonia, non-pneumonic bacterial infections and gastroenteritis
Description: Lay Summary
For many years, medicines like statins and antihypertensives have been prescribed for heart disease. However, heart disease remains one of the leading causes of death globally. Therefore, it is important to keep developing new medicines to treat different causes of heart disease, ultimately providing better treatments for patients. One type of medicine being developed to lower heart disease risk, is a medicine to reduce inflammation. Whilst high levels of indicators of inflammation can increase your risk of heart disease, these indicators are also important for helping your body fight infections. Therefore, there is a worry that these new medicines for heart disease might unintentionally increase the risk of infections.
In this new study, we look at the link between white blood cells (important indicators of inflammation) and risks of different types of infections (such as lung infections and infections of the blood) in patients we expect to be given these new medicines. We compare the number of infections in this patient group with the general population to see whether we see more, or less, infections than we might expect by chance.
It is essential that when we bring new medicines to patients, we not only know the benefits of the treatments, but also any potential risks. These benefits and risks should be balanced against each other. That is why this study is so important: we can learn more about our patients who might get these new medicines, as well as how safe the medicines are for these patients.
Technical SummaryThis study aims to identify whether low white blood cell (WBC) counts, including measurements of neutrophil, lymphocyte and monocyte levels, are associated with an increased risk of infection (e.g., sepsis, endocarditis, meningitis and tuberculosis) in cardiometabolic disease patients. Several drugs are in phase 3 clinical trials with anti-inflammatory mechanisms for cardiometabolic disease. Both immunosuppression and cardiometabolic diseases are associated with increased risk of infections. Therefore, there is a concern these treatments may inadvertently increase infection risk.
Previous analyses investigating the association between low WBC count and infection risk, including pneumonia and sepsis, have rarely used both primary and secondary care health data. Whilst primary care data captures information on WBC count, many infections, particularly severe infections, will only be recorded in secondary care data. Much of the literature also looks at the risk in the general population, rather than within specific patient populations.
This observational cohort study will identify patients aged 18+ from CPRD Aurum primary care data from 2000 until 2024 (or the most recent data available) with linkage to HES admitted patient care, HES outpatient and HES Accidence and Emergency data, to capture both WBC count (exposure) and number, type and severity of infections (outcomes), and to characterise a population of patients with cardiometabolic disease. We will look at the association between WBC and infection risk in cardiometabolic diseases patient populations, including those with atherosclerotic cardiovascular disease (ASCVD), Type 2 diabetes (T2D) and heart failure (HF) and compare the effects to those in the non-cardiometabolic disease population (the general population). We will conduct multivariable adjusted cox proportional hazard models. Covariates include age, sex, number of blood tests, number of previous infections, ethnicity, total WBC count, deprivation and baseline comorbidities.
This study will be important to derisk anti-inflammatory treatments for cardiometabolic disease which may soon be on the market.
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Understanding Coeliac Disease Follow-up and Management in Primary Care — Martha Elwenspoek ...
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Understanding Coeliac Disease Follow-up and Management in Primary Care
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-24
Organisations:
Martha Elwenspoek - Chief Investigator - University of Bristol
Katie Charlwood - Corresponding Applicant - University of Bristol
Aws Sadik - Collaborator - University of Bristol
Hayley Jones - Collaborator - University of Bristol
Penny Whiting - Collaborator - University of BristolOutcomes:
Coeliac disease (CD) annual review; blood test ordering; referrals to specialist care; follow-up biopsy; dual-energy x-ray absorptiometry (DEXA) scan; CD follow-up blood test results
Description: Lay Summary
Coeliac disease (CD) is an autoimmune condition triggered by gluten that requires a lifelong gluten-free diet (GFD). National guidelines recommend that people with CD should be followed up annually, which can include blood testing. This study will use patient data from primary care to explore CD follow-up care and the role of blood testing in managing the condition.
Technical Summary
We will describe how follow-up care varies across England and whether differences exist between patient groups. Additionally, we will characterise how blood test results change after diagnosis, typically when patients begin a GFD. We will study how long on average it takes for the blood test results that led to diagnosis to reach a ânormalâ level, assuming that most people begin a GFD when they are diagnosed. We will describe the variation in test result changes within the CD population to explore which characteristics (such as age group and ethnicity) could be linked to slower recovery.
Describing how follow-up blood tests are used and how results change after diagnosis will help us better understand whether these tests are necessary, and when to use these. Furthermore, this study will highlight the variation in CD follow-up care across England and among different patient groups. Our findings will support improvements to clinical guidelines, standardising care and enhancing health outcomes for patients. We plan to share our findings through academic publications, conferences, and collaboration with Coeliac UK to ensure that clinicians, researchers, and patients benefit from this study.Coeliac disease (CD) is an autoimmune condition triggered by gluten that requires a strict, lifelong gluten-free diet as its only treatment. After diagnosis, clinical guidelines recommend annual reviews and monitoring blood tests, however the optimal use of these tests remain unclear.
Using CPRD Aurum and linked datasets, we will describe CD follow-up care and changes in blood test results in CD patients diagnosed after June 2009. We will characterise variation by age, sex, practice deprivation quintile, ethnicity, and region to examine for disparities in care and recovery. Additionally, we will also describe how follow-up care has changed over time by comparing follow-up practices before and after the publication of current NICE guidelines.
Our first objective is to describe the variation in CD follow-up across England. We will use descriptive analyses to examine how many CD patients receive annual reviews, blood tests, and specialist referrals, describing the timing of care after diagnosis. The second objective is to describe changes in test results after CD diagnosis, when patients typically begin a gluten-free diet. We will include patients with at least one follow-up test, standardising results if necessary. Relative changes in test results after diagnosis will be summarised at 6-month intervals, using spaghetti plots and LOESS curves to visualise trends. Kaplan-Meier methods will be used to estimate time to test normalisation in patients with abnormal results to diagnosis. For both objectives, we will examine the variation between patient groups by stratifying our analyses by patient-level factors, practice deprivation and region.
We will identify disparities in current follow-up care and gain insights into the necessity and timing of follow-up testing. Our findings will help inform further research to address key evidence gaps in CD follow-up and management, and provide evidence to improve national guidelines and clinical care for CD patients across England.
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PREDICTion of GastroIntestinal malignancy in patients with IRON Deficiency (PREDICT-GI-IRON) — Leo Alexandre ...
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PREDICTion of GastroIntestinal malignancy in patients with IRON Deficiency (PREDICT-GI-IRON)
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-03
Organisations:
Leo Alexandre - Chief Investigator - University of East Anglia
Leo Alexandre - Corresponding Applicant - University of East Anglia
Allan Clark - Collaborator - University of East Anglia
Helen Parretti - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Nicholas Steel - Collaborator - University of East Anglia
Ramesh Vishwakarma - Collaborator - University of East Anglia
Simon Chan - Collaborator - Norfolk and Norwich University HospitalsOutcomes:
Incident GI malignancy diagnosis (composite of oesophago-gastric, small bowel or colorectal cancer); site specific GI cancers: oesophago-gastric; small bowel; and colorectal cancer.
Description: Lay Summary
One in fourteen adults are found to have low iron levels when they have blood tests. Low iron levels can lead to a low blood count (anaemia). Blood loss from the gastrointestinal tract (food pipe/stomach/intestines) is a common cause, is often asymptomatic, and may be due to cancer. Most patients will not have cancer, but some patient groups are at high risk. Therefore, people with low iron levels are commonly referred by their General Practitioner (GP) for urgent investigation with internal camera tests (endoscopy). However, internal camera tests are invasive, and they can cause uncommon, but serious complications. NHS services are under pressure with growing waiting lists.
Current UK guidelines recommend urgent digestive tract investigation when there is not a clear explanation for a new low blood count caused by low iron levels. However, it is not known how risks of digestive tract cancers vary between different groups. Currently there is no reliable way for GPs to accurately know which people with low iron levels are at most risk. If there were, GPs, hospital specialists, patients and endoscopy units could make more informed decisions about care.
We aim to develop and test a clinical risk calculator called PREDICT-GI-IRON for patients with low iron levels, which will calculate their risk of digestive tract cancer in the next 5 years, based on information in their medical records. We will use anonymous data from GP electronic patient records to develop and test this clinical risk calculator.
Technical SummaryBackground: GI cancers, including oesophageal, gastric, and colorectal cancers, are the second most common cancers in the UK. Approximately one-third of patients with GI malignancy have ID before diagnosis. ID is common finding and is identified in 1 in 14 routine blood tests and risk of cancer is unclear in different patient groups.
Aim: To quantify the relative and absolute risk of GI malignancy in adults with ID anaemia (IDA) and ID without anaemia (IDWA).
Objectives:
1. Separately for adults with IDA and IDWA, estimate the 5-year cumulative incidence of GI malignancy stratified by age group and sex.
2. Estimate the association between ID (separately for IDA and IDWA) and gastrointestinal malignancy compared with those without ID and without anaemia (WIDWA).
3. Develop and externally validate risk prediction models for malignant GI disease in men and women diagnosed with IDA and IDWA (PREDICT-GI-IRON).
4. Develop a user-friendly web-based calculator which incorporates the PREDICT-GI-IRON risk equations.Methods: This prospective cohort study will use Clinical Practice Research Datalink (CPRD) AURUM data (2010â2024), linked with Hospital Episode Statistics (HES) (to identify endoscopic procedures), Office for National Statistics (ONS) mortality data, and National Cancer Registration and Analysis Service (NCRAS) data. Adults aged â¥18 years with newly diagnosed ID and no prior GI cancer will be included. Fine and Gray subdistribution hazard models will estimate five-year cumulative cancer incidence. Subdistribution and Multivariable Cox proportional hazards regression will be used to develop risk prediction models with a five year time-horizon. Model performance will be assessed for calibration and discrimination in derivation and validation datasets. Decision curve analysis will evaluate the clinical utility of models.
Impact: Results will inform risk-based referral pathways, supporting clinicians in prioritising patients for endoscopy, improving outcomes, and optimising NHS resources.
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A retrospective observational study on the epidemiology of diseases of the circulatory system and the healthcare resource use and treatment of patients with these conditions — Craig Currie ...
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A retrospective observational study on the epidemiology of diseases of the circulatory system and the healthcare resource use and treatment of patients with these conditions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-10
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christian Bannister - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Harry Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
John Threlfall - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Jonathan Patrick - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Rhiannon Thomason - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient characteristics; Comorbidities; All-cause healthcare resource use; All-cause healthcare costs; Disease-specific healthcare resource use; Disease-specific Healthcare costs; All-cause mortality; Incidence; Prevalence; Drug treatment pathways; Adherence.
Description: Lay Summary
Cardiovascular diseases (CVD) comprise a variety of conditions affecting the heart, brain, and blood vessels. Risk factors include family history of CVD, increasing age, gender, diabetes, obesity, diet, smoking and other lifestyle characteristics. CVD affects more than 10% of the UK population, and the management of people with CVD accounts for a significant proportion of NHS healthcare expenditure. It is a leading cause of death in the UK.
Technical Summary
The aim of this study is to describe the number of people who have CVD in the UK and estimate the healthcare costs associated with managing these conditions. Research-quality patients with CVD will be selected. The number of new cases of CVD (the incidence) and the proportion of people with CVD (the prevalence) will be calculated on a yearly basis. Time to death and patientsâ characteristics will be presented. The number and cost of GP consultations, GP prescriptions, outpatient attendances and inpatient stays will also be determined. We will explore which medications are prescribed to patients with CVD and at what point in their clinical care pathway. In addition, we will quantify the extent to which patients with CVD take their medication in accordance with the GPâs instructions (adherence).
We hope that the findings from our study will help to support the planning of NHS services and pinpoint areas for future research and development.Our objective is to describe the epidemiology of circulatory diseases, estimate and cost healthcare use in people with these conditions, and describe treatment pathways for cardiovascular drugs. Acceptable patients will be selected from CPRD GOLD and Aurum if they have a medical code indicative of a disease of the circulatory system. For sensitivity analyses, a subcohort will comprise English patients eligible for linkage to the HES admitted patient care (APC) and outpatient datasets and Office for National Statistics (ONS) death registration data. The start of CPRD follow-up will be defined in CPRD Aurum patients as the patientâs registration date and in CPRD GOLD patients as the later of registration date and practice up-to-standard date; the end of CPRD data follow-up will be defined as the earliest of the patientâs transfer-out date, date of death (if applicable), and the last data-collection date for their practice. The presentation date will be defined as that of the patientâs first ever record with a code indicative of the circulatory disease. For incident patients, time to death will be presented using KaplanâMeier analysis. All-cause and disease-specific healthcare resource use and associated costs will be estimated before and after presentation and comprise primary care contacts, primary care prescriptions, outpatient attendances, and hospital admissions. Healthcare costs will be compared with a non-exposed control group of acceptable, linkage-eligible patients matched in a 1:1 ratio on age, sex, general practice (where appropriate), and registration status at the date of the caseâs start of follow-up. Incidence and point prevalence will be calculated on a yearly basis. Treatment pathways will be explored and adherence quantified.
This study will provide valuable information on the healthcare burden associated with diseases of the circulatory system and help to inform healthcare decision-making.
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Cardiovascular Adverse Events of Non-Steroidal Anti-Inflammatory Drugs: A Sequence Symmetry Study — Danielle Newby ...
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Cardiovascular Adverse Events of Non-Steroidal Anti-Inflammatory Drugs: A Sequence Symmetry Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-28
Organisations:
Danielle Newby - Chief Investigator - University of Oxford
Danielle Newby - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Elin Rowlands - Collaborator - University of Oxford
Sai Sumedha Bobba - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of OxfordOutcomes:
Diagnosis of stroke; heart failure; myocardial infarction; pulmonary embolism; deep vein thrombosis; arrythmia; gastrointestinal hemorrhage (negative/positive control); depression (negative control). Gastrointestinal hemorrhage is associated with specific NSAIDs and not others such as coxibs therefore it will be used as both a positive and negative control.
Description: Lay Summary
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), like ibuprofen, are commonly used drugs to treat pain and inflammation. While these drugs are useful, some NSAIDs can cause serious side effects, including heart attacks, and other heart related problems. As many people use NSAIDs, understanding the potential risks of different NSAIDs on the heart and related diseases is important. This study will include adults aged 18 years and older who were prescribed NSAIDs between 2013 and 2023. It will examine the characteristics of people who take NSAIDs, including their age, sex, other medications they use, and pre-existing medical conditions. The study will use a method called Sequence Symmetry Analysis to explore possible links between taking NSAIDs and heart-related side effects, like heart attacks, irregular heart rhythms, and blood clots. This method looks for patterns in medical records to determine if these heart problems might be connected to NSAID use. By better understanding the risks of specific NSAIDs, this study will provide important information to doctors and patients. The results can help improve prescribing decisions and make taking NSAIDs safer for everyone.
Technical SummaryBACKGROUND: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are among the most commonly prescribed medications worldwide, used to treat pain and inflammation. While effective, NSAIDs are associated with a range of adverse drug effects, including renal, and cardiovascular complications. Cardiovascular risks, in particular, have raised significant concern due to the widespread use of NSAIDs so further investigation of the individual safety profile of these drugs is needed.
OBJECTIVES:
1) To characterise demographics, comorbidities and medications prescribed to patients before and after a prescription of NSAIDs.
2) To determine potential cardiovascular adverse drug events related to NSAIDs using Sequence Symmetry Analysis (SSA).STUDY DESIGN: Cohort study
POPULATION: All people in the database from 2013 to 2023.
DRUGS OF INTEREST: Non-steroidal anti-inflammatory drugs (NSAIDs)
VARIABLES: Exposure to NSAIDs will be based on prescription data. Outcomes include cardiovascular and related diseases (e.g. stroke, heart failure, myocardial infarction, pulmonary embolism, deep vein thrombosis, arrythmia etc) will be based on diagnoses data. Demographic information such as age and sex, other medicine use, and diagnoses of comorbidities and possible indications will be identified to characterise the NSAIDs users.
ANALYSES:
Data: CPRD GOLD
Participants: All adults registered in CPRD GOLD for at least 1 year and older than 18 with a prescription for NSAIDs. Descriptive analysis will be used to describe the demographics and clinical characteristics of patients taking NSAIDs. Sequence symmetry analysis will be used to determine potential adverse drug events for NSAIDs related to cardiovascular disease (e.g. stroke, heart failure, myocardial infarction, pulmonary embolism, deep vein thrombosis, arrythmia)PUBLIC BENIFIT: This research will enhance understanding of NSAID safety, helping clinicians make informed prescribing decisions while minimising cardiovascular risks. Identifying potential adverse drug effects will support safer medication use and improve patient outcomes.
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PREscription of statins and antipsychotics associated with diabetes deVelopmENT (PREVENT). — Juan Carlos Bazo Alvarez ...
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PREscription of statins and antipsychotics associated with diabetes deVelopmENT (PREVENT).
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-05
Organisations:
Juan Carlos Bazo Alvarez - Chief Investigator - University College London ( UCL )
Juan Carlos Bazo Alvarez - Corresponding Applicant - University College London ( UCL )
Irene Petersen - Collaborator - University College London ( UCL )
Philip Stone - Collaborator - University College London ( UCL )Outcomes:
Objective 1: Statin and antipsychotic treatment, from the first prescription ever up to the last record within the observation period.
Objective 2: Change in HbA1c over time.
Objective 3: Type-2 diabetes mellitus (T2DM), defined as the first time the patient reports an HbA1c>=6.5% (or >= 48 mmol/mol) or a formal T2DM diagnosis.Clarification Note: Changes in cholesterol, blood pressure, and HbA1c will be included in the models as covariates, not outcomes.
Description: Lay Summary
Some medications used to treat mental health conditions can increase the risk of developing serious health problems, such as high blood sugar, high blood pressure, and abnormal cholesterol levels. These changes can lead to other health complications and may shorten life expectancy. Antipsychotic medications, in particular, are known to sometimes cause weight gain and metabolic changes that contribute to these risks. The risk might be even higher when these medications are used alongside cholesterol-lowering drugs, such as statins, but this combination has not been thoroughly studied.
Our research will explore how taking both medications at the same time may affect the likelihood of developing these health issues, in particular, unhealthy high blood sugar (also known as diabetes). Weâll analyze medical records from over 200,000 people to understand how factors like age, gender, socioeconomic background, and ethnicity might influence this risk. The study will also look at changes in treatment plans, such as dosage adjustments, and track physical health indicators, including blood sugar levels, before and after starting statins while on antipsychotics.
The goal of this research is to better understand how these medications interact, minimize risks, and guide safer prescribing practices. The project team includes experts in mental and physical health and people with lived experience. Weâll share our findings and recommendations through various formats, such as webinars, infographics, and videos, to reach healthcare professionals, patients, and families.
Technical SummaryMore than five million people in the UK are living with diabetes. Some people prescribed antipsychotics increase their weight dramatically, affecting their metabolism and making them more at risk of developing diabetes. Some are prescribed statins to prevent cardiovascular events when other risk factors appear (e.g., higher cholesterol ratio). However, a meta-analysis found that people taking statins are more at risk of developing diabetes than the general population. Therefore, we aim to determine how simultaneous long-term exposure to statins and antipsychotics affects the risk of developing diabetes, with an emphasis on sociodemographic inequalities. We will analyse primary care data to complete the following objectives: 1) examine long-term statin and antipsychotic combined prescription patterns over time and how these vary across sociodemographic characteristics, 2) explore the relationship between these patterns and the change of HbA1c over time and how sociodemographic characteristics might influence this pathway, and 3) determine whether the combined prescription of statins and antipsychotics affects the risk of developing type-2 diabetes; and the role that dosage, cumulative exposure and sociodemographic characteristics play in this. To complete these objectives, we will 1) fit group-based trajectory models to recognise prescription patterns over time, 2) use matched cohorts to perform a controlled interrupted time series analysis of change in HbA1c over time by fitting mixed effect models, and then 3) fit Royston-Parmar survival models for time to diagnosis of type-2 diabetes. Given these findings, we will i) convene a lived experience advisory panel and a stakeholder group integrated by service users, carers and key partners, ii) co-produce, together with these groups, interpretations of study results and recommendations for primary and specialist care clinicians on the use of statins and antipsychotics and the risk of development of diabetes, iii) prepare dissemination materials and execute a plan for promoting the impact of our findings.
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QEMISTRY-Dementia: Quantifying and Explaining MortalIty aSsociaTed with PsYchotropic Drug Prescribing in Dementia. — Juan Carlos Bazo Alvarez ...
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QEMISTRY-Dementia: Quantifying and Explaining MortalIty aSsociaTed with PsYchotropic Drug Prescribing in Dementia.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-07
Organisations:
Juan Carlos Bazo Alvarez - Chief Investigator - University College London ( UCL )
Juan Carlos Bazo Alvarez - Corresponding Applicant - University College London ( UCL )
Holly Smith - Collaborator - University College London ( UCL )
Irene Petersen - Collaborator - University College London ( UCL )
Philip Stone - Collaborator - University College London ( UCL )Outcomes:
Our primary outcome is mortality (all-cause and cardiovascular). Our secondary outcome is safety monitoring tests, including blood pressure, body weight, electrocardiogram (ECG), glucose, lipids, full blood count, liver and renal function and prolactin.
Description: Lay Summary
What is the issue?
Up to one in four people with memory problems are prescribed medications called antipsychotics to manage distressing behaviours like confusion, restlessness, or seeing things that arenât real. However, these medications can double the risk of death for people with memory problems. Despite safety warnings in 2009, many people continue taking these drugs for about six monthsâlonger than recommendedâespecially women and people from minority ethnic backgrounds.What do we want to find out?
We aim to understand how these medications have been used in UK general practices since 2015 by exploring:
1. How often they are prescribed for people with memory problems.
2. Whether recommended safety checks are carried out.
3. If there is a link between these medications and a higher risk of death.
We will also assess whether alternative medications sometimes used instead carry similar risks.What will we do?
Technical Summary
Using anonymous UK medical records, we will explore the link between these medications and death while reviewing whether safety tests are conducted. This research will help ensure medications for memory problems are prescribed safely and fairly.Purpose: To examine antipsychotic use in dementia, analysing prescribing trends, mortality risks, and safety monitoring adherence.
Background: Antipsychotics significantly increase mortality risk in people with dementia, particularly shortly after treatment initiation, with prolonged use further elevating this risk. Current guidelines recommend regular safety monitoring, including assessments of blood pressure, weight, blood glucose, lipid levels, prolactin, liver/kidney function, and electrocardiograms. However, adherence to these guidelines varies widely.
Objectives:
1. To analyse trends in antipsychotic prescribing and substitute medications in dementia, exploring variations by time and patient characteristics.
2. To determine whether dementia patients initiating antipsychotics or substitutes have a higher mortality risk compared to individuals without dementia prescribed the same drugs, and how this varies by treatment duration.
3. To assess whether dementia patients on antipsychotics or substitutes face a higher mortality risk compared to those not prescribed these drugs.
4. To evaluate whether dementia patients prescribed antipsychotics receive appropriate safety monitoring and how this varies by patient characteristics.Methodology: We will include individuals aged 50+ diagnosed with dementia, identified via the Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) from 2015â2024. Annual prescribing rates for antipsychotics and substitutes will be calculated, examining variations by age, sex, ethnicity, and socioeconomic status by fitting multivariable Poisson regression models. Survival analysis will be performed to compare mortality rates for those prescribed these medications in: (1) dementia patients not prescribed these drugs and (2) individuals without dementia prescribed the same drugs. The influence of treatment duration will also be assessed. Additionally, the frequency of safety monitoring tests before and after treatment initiation will be analysed, focusing on variations by demographic factors.
Expected Results: We will address gaps in understanding antipsychotic use in dementia, emphasising mortality risks, disparities across groups, and safety monitoring adherence to inform equitable and safer prescribing practices.
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Using CPRD Data To Investigate Inequalities In Heat-Related Health Outcomes from 2014 - 2024 — Eman Zied Abozied ...
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Using CPRD Data To Investigate Inequalities In Heat-Related Health Outcomes from 2014 - 2024
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-19
Organisations:
Eman Zied Abozied - Chief Investigator - Newcastle University
Eman Zied Abozied - Corresponding Applicant - Newcastle University
Andrew Kingston - Collaborator - Newcastle University
Clare Bambra - Collaborator - Newcastle University
David Sinclair - Collaborator - Newcastle University
Hilary Shepherd - Collaborator - Newcastle University
Laura Woods - Collaborator - Newcastle UniversityOutcomes:
Primary Outcomes:
Heart attacks; DehydrationSecondary Outcomes:
Admission to hospital due to a heat related illness (heart attack or dehydration); Mortality (heart attack or dehydration);All-cause mortality.Description: Lay Summary
Climate change is causing more extreme heatwaves, and this is affecting peopleâs health. In the UK, record-breaking temperatures in recent years have led to more deaths and illnesses. For example, in 2022, around 4,500 more people died than usual because of the heatwaves. Extreme heat can also cause heart attacks and severe dehydration, which might not cause deaths, but can decrease peopleâs quality of life and stress healthcare systems. We know that people in poorer areas are more likely to suffer from health problems, but we donât fully understand how the location or type of area affects the risk of heat related health problems.
Technical Summary
To address this, we are researching how heatwaves affect different groups of people and local areas across England. We want to find out if certain areas, like cities or poorer regions, are more affected by extreme heat. We will look at hospital data, death records, and deprivation data from 2014 to 2024 to see how changes in temperature affect health outcomes, especially during the 2022 heatwaves. By studying the impact of heat on health, we hope to better understand how it affects people in different areas and groups.
The findings from our research could lead to better health responses in the future when heatwaves hit. If we understand which groups and areas are most at risk, public health services can better protect them during heatwaves. This could help reduce health problems and improve care for people affected by extreme heat in the future.Study Objective: To describe the impact of socio-economic and geographic inequalities on heat related illnesses and death in adults after exposure to temperature anomalies during the summer months from 2014-2024 and during the 2022 heatwaves.
Primary exposures and outcomes: The outcomes are acute heat related illnesses, cardiac events after a heat period, and excess deaths. The primary exposure are temperature anomalies, focusing on heatwaves defined by the Met Office. Covariates include age and sex. Stratification variables are measures of inequality: patient-level area deprivation, region and practice-level urban-rural classification.
Data sources: Primary care data from CPRD Aurum, Hospital Episodes Statistics Admitted Patient Care (HES-APC) and Office for National Statistics death registration will be used to define outcomes. Patient-level Index of Multiple Deprivation (IMD) and practice-level urban-rural classification will be used to define inequalities. Temperature exposure will be calculated using temperature datasets from the Met Office on a regional and urban/rural level. Heatwave exposure will be defined by the announcement date by the Met Office.
Study design: This study uses an ecological approach to quantify the effect of temperature on the outcomes at a population level. Firstly, we will describe the baseline monthly rates of the outcomes over 2014-2024. We will use a quasi-Poisson regression model to calculate the temperatureâtime lagâmorbidity relationship. Then, an interrupted time series approach (ITS) will be taken to find differences in rates attributable to exposure to unprecedented heat during the 2022 heatwaves. Finally, the results will be stratified by the inequality measures to find the effect of socio-spatial and geographic inequalities on the outcomes.
Public health benefit: By examining the health impact of temperature anomalies and heatwaves across different demographic and geographic groups, this study will contribute to a better understanding of the intersection between climate change related extreme temperatures and social determinants of health in England.
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Weight management support in primary care: who does it work for, and who does it not work for? A retrospective CPRD population study examining health inequalities — Ruth Jack ...
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Weight management support in primary care: who does it work for, and who does it not work for? A retrospective CPRD population study examining health inequalities
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-19
Organisations:
Ruth Jack - Chief Investigator - University of Nottingham
Kieran Ayling - Corresponding Applicant - University of Nottingham
Barbara Iyen - Collaborator - University of Nottingham
Karen Coulman - Collaborator - University of BristolOutcomes:
Whether or not weight management support (e.g., referral/intervention) was recorded, of what type and how often. Frequency and changes in weight/BMI measurements over time following weight management referral/intervention. We will also work with our patient and public involvement partners to identify further post-referral health outcomes deemed important to patients (e.g., mental health, diabetes incidence).
Description: Lay Summary
Over a billion adults globally, including a quarter of UK adults, live with obesity. Obesity raises the risk of heart disease, type 2 diabetes, certain cancers, and mental health issues like depression and anxiety. It also reduces quality of life and costs the NHS over £6 billion annually.
The NHS offers weight management support to patients living with overweight and obesity through primary care. This support ranges from brief lifestyle advice to referrals to specialist programmes, weight-loss medication, and surgery referrals. However, access depends on local services and policies, creating a âpostcode lotteryâ that patients find unfair.To offer personalised support, we need to understand what works best for whom. Currently, we do not know which patients benefit mostâor leastâfrom different types of weight management support. Patients say this is a key research priority.
This project will use anonymised health records to determine who gets, and who benefits from, different weight management interventions. We will analyse patientsâ medical records to see what support they receivedâsuch as lifestyle programmes, medication, or surgeryâand track weight changes and related health issues over time. We will also examine how factors like age, ethnicity, and other health conditions influence weight outcomes and related health issues.
By understanding which interventions work best for different groups, we can help GPs offer more effective support. If some groups see little benefit from current options, this will highlight the need for novel approaches to better support them.
Technical SummaryBackground:
Obesity affects more than a quarter of UK adults, decreasing life expectancy and quality of life. The NHS offers weight management support to those living with overweight and obesity ranging from brief advice to more intensive interventions and specialist referrals, but there is evidence of access inequalities. Patients say they want access to tailored support, but there is a paucity of evidence exploring which patients benefit mostâor leastâfrom different types of weight management support.Aims:
To explore the frequency with which different types of weight management support are recorded in primary care records, and whether this differs by patient factors â such as age, sex, ethnicity, deprivation, and comorbidities.
To assess weight-related outcomes, and the frequency in which they are captured, across different types of NHS weight management support accessed via primary care (e.g., advice, lifestyle interventions, medication, etc.) and investigate how patient factors moderate their effectiveness.Study Design & Participants:
Retrospective cohort study in CPRD Aurum. We will establish a cohort of adults with records of overweight or obesity, who received NHS weight management support between 2007 and 2024.Outcomes & Covariates:
Type of weight management support received. Frequency of follow-up and changes in weight and related outcomes over time. We will examine whether the support offered, as well as post-support outcomes, vary by socio-demographic factors including age, ethnicity, deprivation, and other health conditions using multivariable linear regression models (and/or non-linear alternatives according to data fit).The findings will provide a first step towards guiding healthcare providers in offering more personalised weight management interventions in primary care. Furthermore, identifying groups for whom current interventions are less effective will signal the need to develop new approaches tailored to these populations, helping reduce inequalities in obesity treatment outcomes.
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Evaluating the Real-World Representativeness of Randomized Controlled Trials of People with Type 2 Diabetes in Primary Care. — Evangelos Kontopantelis ...
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Evaluating the Real-World Representativeness of Randomized Controlled Trials of People with Type 2 Diabetes in Primary Care.
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-28
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Nawwarah Alfarwan - Corresponding Applicant - University of Manchester
Lamiece Hassan - Collaborator - University of Manchester
Maria Panagioti - Collaborator - University of Manchester
Salwa Zghebi - Collaborator - University of ManchesterOutcomes:
The primary outcomes of this study will be descriptive statistics that characterise the participants in diabetes RCTs and their real-world counterparts in primary care data. Specifically, we will measure and report the following: demographics (age, gender, ethnicity, socioeconomic status (Index of Multiple Deprivation, IMD), and duration of diabetes) and biomarkers (Body Mass Index (BMI), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), fasting blood glucose (FBG), Haemoglobin A1c (HbA1c), total cholesterol, High-Density Lipoprotein (HDL) cholesterol, Low-Density Lipoprotein (LDL) cholesterol, triglycerides, and body weight).
Description: Lay Summary
Type 2 Diabetes (T2DM) is a long-term condition causing high blood sugar levels. If blood sugar remains uncontrolled, it can lead to serious health problems such as heart disease and blindness. Even though there are many efforts worldwide to fight the disease, it still causes a lot of deaths in many countries. For instance, around 22,000 people with diabetes die early each year in England alone.
Technical Summary
New healthcare technologies, such as telemedicine (consultations over the internet or telephone), new medications to lower blood sugar, and psychological therapies (like cognitive behavioural therapy or CBT), offer great opportunities for improving diabetes management. Indeed, many studies have shown that these therapies can help manage T2DM. However, the results might not always apply to all patients, especially if the study participants are very different from those who will use the therapy. For example, some ethnic minority groups are often underrepresented in medical studies because of strict selection criteria. So, it is important to compare the study participants with the broader patient population to see if the results are truly applicable.
This study aims to ensure that the results from medical studies can be relevant to most patients with T2DM. We will look at the characteristics of people with T2DM and see how well medical studies represent them in the real world. Using data from the Clinical Practice Research Datalink (CPRD) and advanced statistical methods, we will determine if the people in clinical trials are similar to people with T2DM registered with UK primary care.Background: Many Randomised Controlled Trials (RCTs) have shown that telemedicine, drug trials, and other interventions can improve clinical outcomes for people with T2DM. However, the diverse nature of T2DM often leads to the underrepresentation of relevant subgroups due to restrictive eligibility criteria, raising concerns about the generalizability of trial results to real-world settings. Therefore, it is crucial to investigate the representativeness of these trials in diverse T2DM populations.
Design: Retrospective cohort study.
Methods: We will obtain a cohort of primary care patients with T2DM from the CPRD AURUM database, covering the study period from 2000 onward. This study will estimate the proportion of people with T2DM in England who would have met the eligibility criteria for inclusion in various diabetes randomized controlled trials (RCTs). We will compare the CPRD population to trial participants reported in diabetes RCT publications. Key characteristics, including age, gender, socioeconomic status, Body Mass Index (BMI), and glycated haemoglobin (HbA1c) levels, will be analysed to assess their impact on eligibility and the representativeness of real-world patients compared to trial participants. Statistical analyses will include chi-square tests for categorical variables and t-tests or Mann-Whitney U tests for continuous variables, depending on data distribution. Multivariable logistic regression will be used to adjust for potential confounders. Additionally, the Generalisability Index (GI) will be calculated by computing standardized mean differences (SMDs) for each covariate and aggregating them to assess the representativeness of trial results.
Outcomes: This study will address a crucial gap in understanding how well trial findings translate to the broader T2DM population. It will identify characteristics that differentiate trial participants from the general patient population and enable researchers to conduct trials that include diverse demographic subpopulations.
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DARWIN EU: Association of venous thromboembolism with non-steroidal anti-inflammatory drug use in women 15-49 years using hormonal contraceptives — Daniel Prieto...
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DARWIN EU: Association of venous thromboembolism with non-steroidal anti-inflammatory drug use in women 15-49 years using hormonal contraceptives
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-10
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Xintong Li - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Anna Saura-Lazaro - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
The primary outcome of interest is incident VTE, deep vein thrombosis and pulmonary embolism will be assessed combined and individually.
Description: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources across Europe.
Technical Summary
This study aims to investigate whether there is a link between the use of non-steroidal anti-inflammatory drugs (NSAIDs) and the risk of blood clots (venous thromboembolism or VTE) in women aged 15-49 who are also using hormonal contraceptives. Previous research has shown that hormonal contraceptives can increase the risk of VTE, and a recent study from Denmark suggested that NSAIDs might further increase this risk, especially when used together with hormonal contraceptives.
The study will look at women who start using NSAIDs like ibuprofen, diclofenac, and naproxen while also taking hormonal contraceptives. The researchers will analyse how often these women develop VTE and whether the risk varies with different types of hormonal contraceptives (high, medium, or low risk of VTE).
The first part will describe how NSAIDs are used among women on hormonal contraceptives. The second part will compare the rate of VTE during periods when women are using both NSAIDs and hormonal contraceptives to periods when they are only using hormonal contraceptives using a self-controlled design.
The study will provide valuable information for healthcare providers and regulators to ensure the safe use of these medications in women of reproductive age.Previous studies have established that combined hormonal contraceptives increase the risk of venous thromboembolism (VTE). A recent Danish study indicated that non-steroidal anti-inflammatory drugs (NSAIDs) use might further elevate this risk.
Objective: To assess the association with VTE during concomitant use of NSAIDs prescribed to women taking hormonal contraceptive users aged 15-49 years old.
We will first conduct a drug utilisation study where new users of oral NSAIDs during the use of hormonal contraceptives will be characterised (Objective 1).
Objectives 2 and 3 will use a self-controlled case series (SCCS) design, nested within a cohort of hormonal contraceptive users.
The study population includes women aged 15-49 initiating NSAIDs during hormonal contraceptive use, with a 90-day washout window. The SCCS analysis will focus on women with VTE events during hormonal contraceptive use.
Variables: Exposures include any NSAIDs and specific NSAIDs (ibuprofen, diclofenac, naproxen). We will use paracetamol as a negative control exposure. The primary outcome is incident VTE. Other variables include VTE risk factors and NSAID indications.
Statistical Analysis
Objective 1: We will summarise NSAID use among women aged 15-49 on hormonal contraceptives, including initial and cumulative doses, treatment duration, and number of prescriptions.
Objectives 2 and 3:
In the SCCS analysis, we will compare VTE incidence rates during NSAID exposure to non-exposure periods within individuals. Person-time will be divided into baseline, NSAID exposure, pre-exposure, and post-exposure periods. The SCCS model will use conditional Poisson regression to estimate incidence rate ratios and 95% confidence intervals for VTE during NSAID exposure, adjusting for time-varying confounders.
Sensitivity analyses will include excluding cases who died after VTE, VTE events post-cancer/trauma/hospitalization, and restrict to first contraceptive use episode.
The study will provide valuable information for healthcare providers and regulators to ensure the safe use of NSAIDs in women of reproductive age.
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Evaluation of the updating of the QRISK prediction model on observational health data — Jenna Reps ...
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Evaluation of the updating of the QRISK prediction model on observational health data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-19
Organisations:
Jenna Reps - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Alexander Saelmans - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Peter Rijnbeek - Collaborator - Erasmus University Medical Center ( EMC )
Ross Williams - Collaborator - Erasmus University Medical Center ( EMC )Outcomes:
External validation of QRISK prediction model versions to allow for comparison of performance metrics over time in the CPRD database.
Description: Lay Summary
Clinical prediction models can calculate a personâs individual risk (e.g. 8%) of some future health event. This prediction is made using predictors such as age, sex and medical history. A well performing prediction model can be used to personalize treatment. For a model to be implemented, the consensus is that the model needs to be thoroughly evaluated in different groups of patients.
Technical Summary
As healthcare changes over time (e.g. when new treatments are developed), model performance can get worse. To overcome this, models should be regularly evaluated and if needed, updated. There are different ways to update models and there is currently no optimal strategy to do this.
To investigate optimal updating strategies, we want to first better understand the updating strategies of implemented clinical prediction models. We selected the QRISK (QRESEARCH cardiovascular risk algorithm) prediction model, a model predicting stroke or heart disease, for this. The QRISK prediction model has four versions and has been evaluated with United Kingdom General Practitioner data. Therefore, using Clinical Practice Research Datalink (CPRD) data, general practitioner data, would be ideal to look into the effect of adding predictors on the performance of the model.
This will benefit public health, because clinical prediction models will be used in a more sustainable way. When following optimal updating, they can be used for a longer period of time. Therefore, the patient will be able to benefit for a longer period of time.QRISK is a cox proportional hazards model that was developed to predict the 10-year risk of cardiovascular disease. The outcomes of the model are myocardial infarction, coronary heart disease, stroke and transient ischaemic attacks. The predictors of the model have evolved over time due to updating. (1-4) When it comes to updating, there are various means. Firstly, simple updating consists of recalibration or revision and adjusts a model for novel data settings. Secondly, model extension incorporates new predictors to the model. Also, there are two relatively new updating modelling procedures discussed sparsely in literature. These are meta-modelling, combining multiple models into one meta-model and further updating it for a new dataset and dynamic, either periodic or discrete, updating.(5) For the QRISK model, extension was performed predominantly.(1-4)
We want to perform validation of existing versions of QRISK on the Clinical Practice Research Datalink (CPRD) and we will compare the performance over time, in 6-month intervals of all the different versions of the QRISK model. The CPRD database has been converted to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), which allows for use of standardized cohort and predictor definitions as well as standardized analytics tools developed by the Observational Health Data Science and Informatics (OHDSI) initiative. Also, it was used to develop and update the original QRISK model.(1-4) In clinical prediction models, discrimination and calibration performance are important. Given model specifications, we are replicating the external validation of the QRISK versions and comparing the performance metrics following the addition of predictors.
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Developing and validating a prediction model for temporal risk assessment of major adverse cardiovascular events post COPD exacerbation: using routine healthcare data in England — Jennifer Quint ...
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Developing and validating a prediction model for temporal risk assessment of major adverse cardiovascular events post COPD exacerbation: using routine healthcare data in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College London
Anne Ioannides - Collaborator - Imperial College London
Ye Wang - Collaborator - Imperial College LondonOutcomes:
MACE composite outcome and individual components: acute coronary syndrome (ACS; including MI and unstable angina), arrhythmias, heart failure (HF), ischemic stroke, and pulmonary hypertension (PH). The primary outcome will be the first of any cardiovascular event as determined in HES data using International Classification of Diseases, 10th Revision. For the secondary outcomes, we will evaluate be the MACE components separately. The period of the outcome will be 12 months after the COPD exacerbation index date.
Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a common respiratory condition which affects 10.3% of people aged 30 to 79 world-wide, accounting for approximately 391 million individuals. People with chronic obstructive pulmonary disease (COPD), a condition affecting the lungs, have cough and breathlessness on a day-to-day basis. People with COPD often have acute episodes of deterioration which give them symptoms of worsening breathlessness and cough. These are called acute exacerbations. Patients who have exacerbations face higher risks of death and other adverse outcomes (such as worse quality of life or heart attacks) than those without an exacerbation. Risks of cardiovascular events (e.g. heart failure, heart attacks and irregular heart rhythms) after COPD exacerbation have been recognized. Although factors related to increased risk of cardiovascular disease among COPD patients have been investigated, it remains a big challenge to precisely determine who is at high risk in clinical practice. In this study we will develop a prediction model to see who is at risk of a heart attack or stroke for example in the 12 months after a COPD exacerbation. We hope the information the prediction model will then lead to the development of personalized intervention to prevent or reduce cardiovascular risks.
Technical SummaryCOPD affected 391 million people and was the third leading cause of death globally in 2019. Cardiovascular events are one of the major causes of death among people with COPD, especially those who have an exacerbation. Understanding who is at high risk of cardiovascular events after a COPD exacerbation gives chances to apply precise interventions to help to reduce that risk. Using CPRD Aurum data linked with HES inpatient (APC), ONS mortality data and IMD data, we will develop and validate a prediction model for 12-month temporal risk assessment of major adverse cardiovascular events after COPD exacerbation for people in England. We will include a cohort of people aged 40 years or above, with moderate or severe exacerbation at baseline with a study period of 2008 to 2023. Based on pre-existing knowledge, clinical expertise, and statistical significance, we will generate the candidate prediction variables set. The competing risk model will be used to estimate the coefficient of each predictor. Linearity and interactions will also be assessed. We will use multiple methods including machine learning for better prediction. Both internal and external validation will be undertaken. The model will be expected to provide some visual presentations, such as the nomogram and a webpage calculator.
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Cardiovascular outcomes in Raynaud's Phenomenon and the associations with beta-blockers: a population-based cohort study in England, United Kingdom — Fiona Pearce ...
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Cardiovascular outcomes in Raynaud's Phenomenon and the associations with beta-blockers: a population-based cohort study in England, United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-24
Organisations:
Fiona Pearce - Chief Investigator - University of Nottingham
Anthony Chen - Corresponding Applicant - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Peter Lanyon - Collaborator - Nottingham University Hospitals
Stephanie Lax - Collaborator - University of NottinghamOutcomes:
The outcome of interest in this study is cardiovascular event which will be defined and identified based on diagnoses in CPRD and corresponding Read codes, hospital and death records (ICD-10). Any participants with cardiovascular events recorded prior to the study start will be excluded. Participants will be followed up until first âcardiovascular eventâ, death or the end of the study. Cardiovascular events will include:
1. Cardiovascular death
2. Myocardial Infarction (MI) (non-fatal)
3. Stroke (non-fatal)
4. Angina
5. Heart failure
6. Peripheral arterial diseaseDescription: Lay Summary
Raynaudâs Phenomenon is a condition that affects blood flow around the body, in particular the fingers and toes. It is often triggered by the cold, anxiety, or stress. This causes noticeable changes in skin colour and can be accompanied by pain, numbness, or tingling. Cardiovascular events (i.e., heart attacks and stroke) are the leading causes of deaths worldwide, but it is unknown whether they are more or less prevalent in individuals with Raynaudâs in comparison to their counterparts in the general population. Beta-blockers, a type of medication, can be used to manage and the reduce of risk of cardiovascular events. However, they are also implicated in either provoking or worsening symptoms of Raynaudâs.
This study aims to compare the rates of cardiovascular events between individuals with Raynaudâs and the general population, and then examine its association with beta-blocker use. Cases of Raynaudâs will be defined using electronic medical records from the Clinical Practice Research Datalink (CPRD) and important risk factors such as smoking, lifestyle factors will be considered for in the analysis. These findings are expected to guide doctors to understand their long-term effects of beta-blocker use among Raynaudâs and the associations with cardiovascular disease. Furthermore, this research may encourage doctors to consider whether to discuss the management of cardiovascular disease risk factors during their patientâs first consultation for Raynaudâs.
Technical SummaryThe overarching aim of this study is to investigate the relationship of Raynaudâs Phenomenon with the risk of cardiovascular events in Raynaudâs population and its association with beta-blockers in England, United Kingdom. The objective is to compare the incidence of cardiovascular events in Raynaudâs patients with matched controls from the general population and then to look at the role of beta-blockers in this relationship. The study population includes individuals who have GP diagnosis of Raynaudâs identified using Read codes in the Clinical Practice Research Datalink (CPRD) in England, United Kingdom from 2003 to 2024. A matched general population cohort, based on age, sex, and GP practice, will serve as the comparison group. The primary exposure of this study are individuals with GP-diagnosis of Raynaudâs, while the secondary exposure is beta-blocker use. The outcome of interest in this study is the incidence of cardiovascular events. The study will use CPRD Aurum, specifically the ONS death registration data, HES admitted patient care and HES outpatient datasets.
This study will apply a cohort study design using a Cox proportional hazards model while adjusting for factors like smoking and other risk factors like comorbidities and medications to achieve its aims. The intended public health benefit of this research is to guide clinicians and doctors to understand the effects of Raynaud disease and beta-blocker use between Raynaudâs and general population on cardiovascular event risk, whilst minimising risk of exacerbation of Raynaudâs symptoms. This could lead to personalised treatment strategies and a better balance in risks of beta-blockers therapy for these patients. This research may encourage doctors to consider whether to discuss the management of cardiovascular disease risk factors during their patientâs first consultation for Raynaudâs. Addressing this gap in knowledge is crucial.
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Trends in tobacco use and cessation in the UK from 2018-2024: a descriptive study — Jennifer Quint ...
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Trends in tobacco use and cessation in the UK from 2018-2024: a descriptive study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-25
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Alexander Adamson - Corresponding Applicant - Imperial College LondonOutcomes:
current tobacco smoking prevalence and incidence; ex-tobacco smoking prevalence and incidence; vaping prevalence and incidence; ex-vaping prevalence and incidence; smoking cessation referrals incidence; smoking cessation drug prescriptions incidence; quit attempts incidence
Description: Lay Summary
This study aims to understand smoking and vaping trends in the UK using patient data from the Clinical Practice Research Datalink (CPRD). By analysing health records from 2018 to 2024, the study will calculate the proportion of people who currently smoke or vape, those who have quit, and those who receive help to stop smoking, in each year from 2018-24.
The study has four main goals:
Prevalence of smoking and vaping â This will measure how many people currently smoke or vape in each year of the study. The percentage of smokers and vapers will be calculated by comparing the number of current or former smokers to the total number of people in the dataset. Results will also be analysed by age, sex, region, ethnicity, and socio-economic status.
New cases of smoking and vaping â This will measure how many people start smoking or vaping each year. The study will include people who were never smokers or ex-smokers and count how many begin smoking or vaping.
Success and failure of quitting â This will measure how many people successfully quit smoking or vaping and how many try but fail. A person will be considered a successful quitter if they stop smoking for at least a year.
Use of stop-smoking support â This will measure how many smokers receive referrals to quit-smoking services or are prescribed medications to help them quit.
The findings will help policymakers and healthcare providers understand smoking behaviours and improve support for people who want to quit.
Technical SummaryThis study will estimate smoking and vaping prevalence and incidence, and incidence of quit attempts, cessation referrals and prescriptions, in each year from 2018-2024, focusing on how estimates differ by age, sex, socio-economic status, region, and ethnicity.
The study has four aims:
Prevalence estimation â The number of current and ex-smokers/vapers will be identified each year using the most recent smoking or vaping code available. This will be expressed as a proportion of the total number of registered patients at the midpoint of each year, with confidence intervals calculated. Prevalence will be stratified by patient characteristics (age, sex, region, deprivation, and ethnicity). Detailed regional ethnicity data available in the 2021 ONS census will be applied to the CPRD denominator file by region to provide a suitable denominator for ethnicity estimates.
Incidence estimation â Smoking and vaping initiation rates will be calculated using patient-years as the denominator. Two denominators will be used: (1) never-smoker patient-time and (2) never- and ex-smoker patient-time. An individual receiving a current-smoking code during the year will indicate an incident case, and their remaining patient-time will be excluded.
Smoking and vaping cessation â Successful cessation will be defined as an ex-smoking code or a smoking cessation code appearing in the record after a current-smoking code, with no subsequent smoking codes for at least one year. Unsuccessful quit attempts will be defined by unsuccessful quit codes or relapse within a year.
Smoking cessation interventions â The study will estimate the incidence of smoking cessation referrals and smoking cessation medication prescriptions. Only the first instance of a referral or prescription will be counted, and subsequent patient-time will be excluded from the denominator.
The analysis will be carried out in R and estimates will be accompanied by confidence intervals. The findings will inform public health strategies to reduce smoking prevalence.
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From Clinical Trials to Real-World Data Using CPRD Aurum: Cardiovascular Risk Models for People Living With or Without Type 2 Diabetes — Christian Kruse ...
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From Clinical Trials to Real-World Data Using CPRD Aurum: Cardiovascular Risk Models for People Living With or Without Type 2 Diabetes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-03-11
Organisations:
Christian Kruse - Chief Investigator - Novo Nordisk A/S
Christian Kruse - Corresponding Applicant - Novo Nordisk A/S
Agnes Martine Nielsen - Collaborator - Novo Nordisk A/S
Amine Lotfi - Collaborator - Novo Nordisk A/S
Emil Martiny - Collaborator - Novo Nordisk A/S
Tariq Halasa - Collaborator - Novo Nordisk A/SOutcomes:
Primary Outcome: Major Adverse Cardiovascular Events (MACE), i.e. non-fatal MI, non-fatal stroke, and cardiovascular death.
Secondary Outcomes: Individual components of MACE, i.e. non-fatal MI, non-fatal stroke and cardiovascular death; âMACE+â i.e. non-fatal MI, non-fatal stroke, and ACM.
Description: Lay Summary
Heart disease and stroke are serious diseases that can be prevented with early intervention. Diabetes, which means having high levels of sugar in the blood, is a risk factor that increases the risk of heart disease, like smoking, high blood pressure, and having relatives with heart disease. Researchers have created calculators that use data from hospitals and doctor's offices to assess the risk of developing heart disease and stroke over ten years. Imagine there were 100 copies of you; these calculators could predict how many might develop heart disease in ten years. Many companies make medications to prevent heart disease and stroke, and when developing these medications, data from thousands of people over several years are collected in experiments called clinical trials. We aim to understand how well these risk calculators compare using data from clinical trials and routine data from doctors. We will use anonymized data from the Clinical Practice Research Datalink (CPRD). We will create hypothetical cohorts of patients who could have participated in medication trials and test how well risk calculators predict heart disease and stroke. Our primary focus will be on people with diabetes and/or who are living with overweight or obesity based on their height and weight. Once we complete this study, we can show how well risk calculators work in both medication trials and the real world. This information can help doctors use risk calculators better and target which medications to give to which patients. Our findings will inform clinical guidelines with real-world data.
Technical SummaryThe aim of this study is to evaluate the translatability of cardiovascular disease (CVD) risk prediction models between clinical trial data (CTD) and real-world data (RWD) using CPRD Aurum.
The study populations are people living with or without type 2 diabetes (T2D) with at least one body mass index (BMI) measurement and registration with the between 2010 and 2022. We combine laboratory measurements, vital signs, comorbidities and medication exposure as primary exposures. The primary outcome is Major Adverse Cardiovascular Events (MACE), i.e. non-fatal myocardial infarction (MI), non-fatal stroke, and cardiovascular death. Secondary outcomes are the individual components of MACE, and "MACE+", i.e. MACE with all-cause mortality (ACM).
We use data from CPRD Aurum, Hospital Episode Statistics (HES), and the Office of National Statistics (ONS). The study will employ a retrospective cohort design with prediction elements. We utilize existing risk calculators developed by Novo Nordisk (NN) in cardiovascular outcome trials (CVOTs), established risk calculators such as QRISK3®, SCORE2® and PREVENT®, and develop models on the CPRD Aurum data that can be tested on the NN CVOT populations.
For all individuals, we investigate multiple timepoints between 2010 and 2022 for eligibility in existing, current, and future NN CVOTs based on inclusion and exclusion criteria. Prediction models built on NN CVOTs will be tested for discrimination and calibration on emulated RWD populations. We will similarly build models on the RWD data and test on the NN CVOT data, and test published risk models on both. We will use Cox proportional hazards models incorporating regularization, landmarking, and competing risks, as well as machine learning algorithms.
The public health benefit includes improving the accuracy and applicability of CVD risk models. This can enhance patient care and inform clinical guidelines into the differences between CTD and RWD risk predictions.
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ID-183-7: Estimating inequalities in unmet clinical need in patients with obesity — Lane Clark & Peacock LLP...
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ID-183-7: Estimating inequalities in unmet clinical need in patients with obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Obesity. Commercial
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ID-454: Impact of Structured Medication Review for Adults with Polypharmacy in Primary Care — Imperial College NHS Healthcare Trust...
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ID-454: Impact of Structured Medication Review for Adults with Polypharmacy in Primary Care
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Primary Care.
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ID-177-6: Extension: Grenfell Population Health Monitoring — Westminster City Council...
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ID-177-6: Extension: Grenfell Population Health Monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: North Kensington.
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ID-452: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy — Imperial College NHS Healthcare Trust...
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ID-452: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Family size.
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ID-418-2: Extension: The effect of herpes zoster vaccination on vascular inflammation-related health outcomes — Imperial College Healthcare NHS Trust...
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ID-418-2: Extension: The effect of herpes zoster vaccination on vascular inflammation-related health outcomes
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Vaccination. Commercial
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ID-252-4: Extension: Grenfell Bereaved and Survivors Population Health Monitoring — Westminster City Council...
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ID-252-4: Extension: Grenfell Bereaved and Survivors Population Health Monitoring
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Grenfell.
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ID-455: Strategic Project Support (#2035, Health and Wellbeing board Strategy and North Paddington Program) — Westminster City Council...
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ID-455: Strategic Project Support (#2035, Health and Wellbeing board Strategy and North Paddington Program)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: health and wellbeing.
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ID-450: High Intensity Users scoring algorithm — Imperial College NHS Healthcare Trust...
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ID-450: High Intensity Users scoring algorithm
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: HIU.
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ID-190-2: Extension: Evaluation of clinical parameters following COVID-19 infection in pregnancy (COpregVID) — Chelsea & Westminster Hospital NHS Foundation Trust...
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ID-190-2: Extension: Evaluation of clinical parameters following COVID-19 infection in pregnancy (COpregVID)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Chelsea & Westminster Hospital NHS Foundation Trust
Description: Covid in pregnancy.
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ID-456: Understanding the gaps in hypertension care in primary care in Northwest London — Imperial College Healthcare NHS Trust...
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ID-456: Understanding the gaps in hypertension care in primary care in Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Primary care.
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ID-457: Morebility: Medications, Mental Health, Mobility — Imperial College London...
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ID-457: Morebility: Medications, Mental Health, Mobility
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mobility.
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ID-249-3: Extension: The impact of COVID-19 on antibiotic prescribing in North West London — Imperial College London...
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ID-249-3: Extension: The impact of COVID-19 on antibiotic prescribing in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Antibiotics.
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ID-135-8: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease — Lane Clark & Peacock LLP...
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ID-135-8: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Cardiovascular Disease. Commercial
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ID-407-2: Extension: Evaluation of virtual consultations in primary care: assessing the effectiveness of eConsult — Imperial College London...
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ID-407-2: Extension: Evaluation of virtual consultations in primary care: assessing the effectiveness of eConsult
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: eConsult.
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ID-390-3: Identifying risk factors associated with subsequent mental health crisis for children and young people in North West London — Imperial College London...
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ID-390-3: Identifying risk factors associated with subsequent mental health crisis for children and young people in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental health. Commercial
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ID-451: Optimizing Hospital Layouts for Resilience: Exploring the Impact of Spatial Configuration on Infection Prevention and Control — Brunel University London...
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ID-451: Optimizing Hospital Layouts for Resilience: Exploring the Impact of Spatial Configuration on Infection Prevention and Control
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-25
Opt Outs: no information provided./p>
Organisations: Brunel University London
Description: Hospital layouts.
Source
2025 - 02
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Prescribing patterns for menstrual and uterine disorders in primary care in England from 2014 -2024 — Ruth Brauer ...
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Prescribing patterns for menstrual and uterine disorders in primary care in England from 2014 -2024
Datasets:GP data, CPRD Aurum Ethnicity Record; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-16
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Simisola Fakoya - Corresponding Applicant - University College London ( UCL )
Bryony Franklin - Collaborator - University College London ( UCL )
Chengsheng Ju - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )Outcomes:
1. Primary care diagnoses of the following menstrual and uterine disorders: abnormal uterine bleeding, amenorrhea, dysmenorrhea, menorrhagia, endometriosis, polycystic ovary syndrome, adenomyosis, premenstrual syndrome, premenstrual dysphoric disorder, endometrial hyperplasia without atypia, uterine prolapse, uterine polyps and uterine fibroids.
2. Prescribing trends of the following medications used for treatment of menstrual and uterine disorders:
⢠Single constituent and fixed dose combination analgesics preparations including non-steroidal anti-inflammatory drugs, aspirin, paracetamol and weak opioids:codeine, dihydrocodeine and tramadol;
⢠Hormonal contraceptives for treatment of menstrual and uterine disorders including various combinations, strengths and formulations of combined hormonal and progesterone only contraceptives;
⢠Tranexamic acidDescription: Lay Summary
Menstruation or periods usually involves vaginal bleeding for a few days every month. This is part of the normal menstrual cycle for people of female sex. Periods usually start around age 12 and end between ages 45-55.
Some people may experience heavy, painful and/ or lengthy bleeding. Such menstrual and uterine disorders are very common and can be managed with medication.
Medicines often used to manage these conditions include tranexamic acid, contraception with hormones and/ or pain relief medication.
Tranexamic acid works by reducing bleeding. Contraception with hormones can change and regulate periods to reduce bleeding and pain. Pain relief medication can be helpful to reduce pain.
In recent years, community groups and individuals have raised more awareness of menstrual and uterine conditions. We want to describe how often these conditions are diagnosed in primary care and the number of people living with these conditions. We would also like to know how often tranexamic acid, hormonal contraceptives and pain relief medication are used in these people.
We will use anonymised Clinical Practice Research Datalink medical data. We will look at medical records of people aged 12-55 years (the typical age range for menstruation) and see how often people were diagnosed with menstrual and uterine disorders between 2014 and 2024. We will also describe how often the above medications were prescribed within this group.
Results of the study will provide more information for further research. This will allow people to make more informed choices to manage their menstrual and uterine conditions.
Technical SummarySymptoms of menstrual and uterine disorders include prolonged, irregular and/or painful menstruation and are prevalent in up to 37% of the female sex.
Quality of life and impact on wellbeing can be severely negatively affected by these disorders as they can result in pain, depression, anxiety, sleep disturbances, absenteeism and disruption to academic and professional performance.
Symptoms of menstrual and uterine disorders are frequently managed in primary care with analgesics, tranexamic acid and/or hormonal contraceptives.
Limited studies have been conducted on prevalence of menstrual and uterine disorders and current prevalence data are incomplete and inconclusive.
Therefore it is imperative to describe primary care diagnoses and prescribing patterns for the treatments of menstrual and uterine disorders in England and explore whether they have changed over time.
We intend to describe the trends in diagnoses and treatments of these disorders by describing the incidence and period prevalence of diagnoses of these disorders and detailing the various pharmacological and non-pharmacological treatments used. We will also describe the year-by-year prescribing trends of analgesics, hormonal contraceptive agents and tranexamic acid.
From the data, we will calculate and compare the proportion of annual prescriptions containing these medications from 2014 to 2024 to all pharmacological and non-pharmacological treatments used for these disorders.
Data will be analysed using trend analysis and descriptive statistical methods.CPRD Aurum data will be used to select a cohort population of female sex with menstrual and uterine disorders aged 12-55 with a CPRD follow-up duration from 2014 to the last available data in 2024.
Results will be stratified by age at which the person was diagnosed and the medication prescribed, duration of prescription, body mass index, ethnicity and socio-economic status.
The results will inform future hypothesis studies on the safety profile of these treatments for management of these disorders.
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Assessing and predicting the excess risk of diabetes progression in at-risk subpopulations — John Dennis ...
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Assessing and predicting the excess risk of diabetes progression in at-risk subpopulations
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-26
Organisations:
John Dennis - Chief Investigator - University of Exeter
Katie Young - Corresponding Applicant - University of Exeter
Andrew Hattersley - Collaborator - University of Exeter
Andrew McGovern - Collaborator - University of Exeter
Angus Jones - Collaborator - University of Exeter
Beverley Shields - Collaborator - University of Exeter
George Allen - Collaborator - University of Exeter
Laura Güdemann - Collaborator - University of Exeter
Martha Dinsdale - Collaborator - University of Exeter
Nicholas John Thomas - Collaborator - University of Exeter
Pedro Cardoso - Collaborator - University of Exeter
Rhian Hopkins - Collaborator - University of Exeter
Robert Kimmitt - Collaborator - University of Exeter
Thijs Jansz - Collaborator - University of Exeter
Trevelyan McKinley - Collaborator - University of ExeterOutcomes:
- Diabetes diagnosis;
- Diabetes progression: this study will involve producing a definition or definitions of progression which are clinically meaningful and meaningful to patients, which may include:
* Treatment progression (e.g. time to requiring insulin, number of tablets);
* Glycaemic control (longitudinal HbA1c and hospitalisation for diabetes-related outcomes including hypoglycaemia and hyperglycaemia/diabetic ketoacidosis);
* Weight gain;
* Development of acute and chronic diabetes related complications (microvascular, cardiovascular, renal, liver, hospitalisation, mortality)Description: Lay Summary
This project aims to explore why certain groups of people are more likely to develop diabetes that progresses to more severe complications. Diabetes is a condition where a personâs blood sugars are too high, which can lead to serious complications affecting the eyes, kidneys, and nerves, and a higher risk of heart attacks and strokes.
We want to understand more about how patient-related factors such as ethnicity, deprivation, age, and the presence of health conditions other than diabetes affect how likely a person is to experience more severe diabetes, including worsening blood sugar and diabetes-related complications. If possible, we want to combine these factors in tools to predict which patient groups are at high risk of more severe diabetes, who might benefit most from access to specific care and treatment.
In addition, many treatments which were developed for use in diabetes to lower blood sugar have added benefits (e.g. for heart/kidney disease and weight loss). Therefore, we want to know what the risks and benefits of treatment are in these at-risk diabetes subgroups and the diabetes population as a whole compared to those without diabetes. This will provide healthcare professionals with important new evidence on how to best manage people at risk of more severe diabetes, including better targeting and tailoring of current treatments.
Technical SummaryBackground: There is evidence that certain patient subgroups are at higher risk of experiencing diabetes-related complications. In addition, patients in these subgroups may receive different care, which in turn can impact the risk of diabetes-related complications. However, many of these groups are under-researched in the UK.
Aim: To characterise the risk of developing diabetes complications in at-risk patient subgroups (including ethnic minorities, those from deprived backgrounds, those diagnosed at a younger age, and those with conditions predisposing to diabetes such as pancreatic damage and autoimmune conditions) compared to the general diabetes population and the general population without diabetes.
Study population: All patients with diabetes from 2004 to date, plus general population controls.
Primary exposures: Sociodemographic characteristics including age, sex, ethnicity, social deprivation; diabetes subtype and age of diagnosis; glycaemic control; other clinical features including co-morbidities and laboratory measurements.
Primary outcomes: Diabetes diagnosis and diabetes progression. Exact definition of diabetes progression to be developed during the project, in consultation with Patient and Public Involvement groups, to likely include: glycaemic control (longitudinal HbA1c, diabetes related hospitalisation), treatment progression, weight gain, complications (microvascular, macrovascular, obesity-related) and mortality.Data sources: CPRD Aurum, Hospital-episode statistics, ONS death data, patient-level Index of Multiple Deprivation.
Methods: Survival and repeated measure regression models, accounting for appropriate confounders, will be used to estimate diabetes progression in key at-risk subgroups compared to the remaining diabetes population and the general population without diabetes. Prediction models for progression will be developed following TRIPOD-AI guidance using regression and tree-based methods. Causal methods, including instrumental variables, will be deployed to estimate the effect of diabetes treatment on progression risk.
Intended public health benefit: This work will provide evidence for targeting limited resources such as diabetes management resources and medication for cardiorenal and weight outcomes to patients who would benefit most from receiving them.
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Investigating the role of infections in Multiple Sclerosis: Retrospective case-control study on the development of Multiple Sclerosis and a cohort study on factors influencing infection risk in people with established MS. — Ruth Dobson ...
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Investigating the role of infections in Multiple Sclerosis: Retrospective case-control study on the development of Multiple Sclerosis and a cohort study on factors influencing infection risk in people with established MS.
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Ruth Dobson - Chief Investigator - Queen Mary University of London
Emily Tregaskis-Daniels - Corresponding Applicant - Queen Mary University of London
Benjamin Jacobs - Collaborator - Queen Mary University of London
Garth Funston - Collaborator - Queen Mary University of LondonOutcomes:
Multiple Sclerosis; All-cause infections; Infection-related mortality; Prescriptions; Infection-related outpatient admissions; Infection-related symptoms (E.g., Lower Urinary Tract symptoms).
Infection-related secondary care interaction will be measured using diagnostic data from HES OP, APC and A&E data.Description: Lay Summary
Rationale: Before a multiple sclerosis (MS) diagnosis, people may attend their GP more often. This early phase, when people experience non-specific symptoms before they are diagnosed with MS, is called the âMS prodromeâ. While some infections may indicate someone has prodromal MS, other infections particularly in childhood (e.g., glandular fever), may be a risk factor for MS. Understanding which infections may be risk factors and which are prodromal features is critical to help us work out how and when MS starts. Furthermore, after someone is diagnosed with MS, they are more likely to experience infections. Currently, we donât know all the factors that may influence infection risk in people with MS (pwMS).
Technical Summary
Methods: We will use information from primary care and hospital records to (1) explore infections that may increase MS risk, (2) explore infections that may be a feature of the MS prodrome, and (3) spot factors that may increase the risk of infection in pwMS.
Results and potential impact: To inform healthcare professionals, such as a General Practitioners (GPs), firstly about early warning signs that someone may be at higher risk for developing MS. Helping to spot MS earlier, enabling earlier treatment and reducing the impact of MS. Secondly, to spot pwMS who are more likely to experience frequent and serious infections, helping to prevent and manage infections. Potential public benefit: Improving our understanding of how infections contribute to MS and what increases infection risks, may lead to earlier detection and better management of MS in primary care.Specific infections may contribute to MS, while others, like urinary tract infections (UTIs), might signal the MS prodrome. Disentangling infections as a risk factor for MS vs. a feature of the MS prodrome is crucial to enhance our understanding of MS and improving time to diagnosis. PwMS are more susceptible to infections, yet factors influencing infection risk remain underexplored. Aims: (1) explore the pattern of infections prior to MS onset and (2) explore factors that may predict infection risk in pwMS. Objectives: (1) determine whether changes occur in the pattern of infections prior to MS over the life course, differentiating prodromal features from risk factors, (2) assess the severity of infections during the MS prodrome, (3) identify risk factors influencing infection risk in PwMS, with a focus on disability levels, disease-modifying treatment (DMT) exposure, and social determinants of health (SoDH), and (4) evaluate risk factors contributing to serious infections among PwMS. PwMS will be matched 1:10 on birth year, sex, and location with three control groups: (1) healthy controls, (2) people with rheumatoid arthritis (RA), and (2) people with migraine. Linked secondary care data will provide proxies for infection severity. Analyses will include Cox proportional hazards regression to explore infections as a risk factor vs. prodromal feature, Poisson regression to examine predictors of infection frequency, and multinomial regression to explore predictors of infection type and infection severity. Interaction terms from area-level datasets will explore associations in diverse socioeconomic groups. Results will help clarify the role of infections in MS onset, enabling earlier detection and treatment. Results will help identify predictors of infections in pwMS, supporting development of individualised risk assessments and preventive strategies. Potential public benefit: Understanding the role of infections in MS and factors influencing infection risk could aid more timely MS detection and management within primary care.
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Risk of self-harm and suicide after diagnosis of dementia: a self-controlled case series and case-crossover study — Hamish Naismith ...
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Risk of self-harm and suicide after diagnosis of dementia: a self-controlled case series and case-crossover study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-21
Organisations:
Hamish Naismith - Chief Investigator - University College London ( UCL )
Hamish Naismith - Corresponding Applicant - University College London ( UCL )
Alexandra Pitman - Collaborator - UCL Division of Psychiatry
Alvin Richards-Belle - Collaborator - University College London ( UCL )
David Osborn - Collaborator - University College London ( UCL )
James Bailey - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Neil Davies - Collaborator - University College London ( UCL )Outcomes:
Self-harm, including events of undetermined intent; suicide, including open verdicts.
Description: Lay Summary
For people with dementia, receiving a diagnosis can bring welcome clarity and help them understand their symptoms and access the right support. It can also facilitate people with dementia and their loved ones in planning for the future. However, some people experience significant mental health difficulties following dementia diagnosis and might be at risk of harming themselves. Recent studies have shown that there is an increased risk of suicide in the three months after receiving a dementia diagnosis. There is also evidence that people with a recent dementia diagnosis are at greater risk of self-harm.
Currently, we know little about precisely when and why this group of people with a recent dementia diagnosis are at greater risk of harming themselves. We seek to close this knowledge gap by using a study design that allows us to investigate in detail when people with dementia tend to harm themselves. This can help us understand critical periods when people with dementia are most at risk. We will also include other factors, such as whether or not they are depressed and the type of dementia they have. This will help us explain why people with dementia are at greater risk at certain times.
Knowing more about when and why people with dementia harm themselves will enable us to better target the support that people are offered after they receive their dementia diagnosis. For example, post-diagnostic support services could provide additional support for those most at risk and ensure depression is properly treated.
Technical SummaryRecent studies have found that the risk of suicide in people with dementia is elevated in the 3 months after diagnosis and in under 65s. We aim to investigate, in more fine-grained detail than achieved previously, the outcomes of self-harm and suicide in people with dementia in the pre- and post-diagnostic periods.
Using CPRD Gold and Aurum, we will include people aged â¥45 with the exposure of dementia diagnosis. Linked data will increase the accuracy of measured outcomes: Hospital Episodes Statistics for self-harm and Office for National Statistics data from coronerâs reports for suicide.
We will employ two related, case-only study designs to study our two outcomes. Our first study design is the self-controlled case series (SCCS), which we will use to investigate self-harm. We will compare the incidence of self-harm during periods of hypothesised excess risk (0-3 months and 3-6 months after recorded dementia diagnosis) to the incidence during the baseline risk period (12-15 months preceding dementia diagnosis). This will be tested using conditional Poisson regression. Cases serve as their own controls in the SCCS method, efficiently controlling for time-invariant confounding factors.
The case-crossover study design will be employed in our second study investigating suicide. We will have a pre-event period (6 months prior to suicide) and a control period. Using conditional logistic regression, we will test the hypothesis that the odds ratio of dementia diagnosis occurring during the pre-event period compared to the control period will be >1. In both studies, covariates will include sociodemographic and clinical factors. When reporting results, low cell numbers will be censored to minimise unintentional disclosure risks. Findings from this research could help improve post-diagnostic support for people with dementia, for example raising awareness among clinicians of critical risk periods, informing dementia public health policy and clinical practice guidelines for memory clinics.
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The Impact of Estradiol + Dydrogesterone on Menopause Estrogen Deficiency Symptoms Treatment — Anne Broe ...
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The Impact of Estradiol + Dydrogesterone on Menopause Estrogen Deficiency Symptoms Treatment
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-21
Organisations:
Anne Broe - Chief Investigator - IQVIA Ltd ( UK )
Christelle Elia - Corresponding Applicant - IQVIA Ltd ( UK )
Emma Rezel-Potts - Collaborator - IQVIA Ltd ( UK )
Julia Gallinaro - Collaborator - IQVIA Ltd ( UK )
Peter Egger - Collaborator - IQVIA Ltd ( UK )
Sarah Lay-Flurrie - Collaborator - IQVIA Ltd ( UK )
Simeon Stavrev - Collaborator - IQVIA Solution Bulgaria EOOD
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Vishalie Shah - Collaborator - IQVIA Ltd ( UK )Outcomes:
- Incidence (new clinical recording of condition after the index date with no historical recording of condition) of breast cancer (BC); venous thromboembolism (VTE); endometrial cancer (EC): ovarian cancer (OC); ischemic heart disease (IHD): ischemic stroke (IS).
- All-cause mortality (record of death after the index date).
Description: Lay Summary
Hormone replacement therapy (HRT) is often prescribed to women experiencing menopause symptoms such as hot flashes and brain fog due to a decline in the female hormone oestrogen. HRT is available in different forms, some containing oestrogen alone and others combining oestrogen with the other female hormone progestogen. Some studies indicate potential risks of HRT use including diseases of the heart and blood vessels and cancer. However, this is dependent on factors such as type of HRT and usage duration. Several types of progestogen exist including dydrogesterone, available in the HRT named Femoston - the focus of our study.
We will use anonymised medical records from general practices in England to select women according to types of HRT usage. The aim of this study is to compare future diagnoses of breast and other forms of cancer and diseases of the heart and blood vessel across groups of women using 5 distinct types of HRT including Femoston. We will also describe the risk of cancer and heart and blood vessel diseases in women of the same age with a menopause diagnosis but who have never used HRT. We will explore if results are impacted by the timing (current, recent, past) of HRT use, duration (short/long term) of HRT use, dosage (high/low) of oestrogen in the HRT, and womenâs age. This research will lead to a better understanding of the risk profile of different types of HRT to enable informed decision making when women seek treatment for menopausal symptoms.
Technical SummaryCombined hormone replacement therapy (HRT) is associated with an increased risk of breast cancer (BC) and venous thromboembolism (VTE). Dydrogesterone is a form of progestogen only available in the combined oral HRT known as Femoston and may provide a safer BC and VTE risk profile than the progestogens in other oral HRT forms. We will use the Clinical Practice Research Datalink (CPRD) Aurum to conduct a population-based cohort study, evaluating incidence of BC, VTE, and other cancer and cardiovascular disease (CVD) endpoints among patients who have initiated Femoston, compared to cohort of patients on other forms of oral combined HRT.
Separate weighted Cox Proportional Hazards (PH) models will examine the outcomes of BC, VTE, endometrial cancer (EC), ovarian cancer (OC), ischemic heart disease (IHD), ischemic stroke (IS) and all-cause mortality following HRT initiation. Propensity scores will be estimated separately for each pairwise (Femoston-control) comparison to account for relevant confounding variables. The effects of stratifying HRT exposure by timing of HRT use and duration on these clinical endpoints will be explored using landmark analysis. Further stratified analysis will explore age and dosage at HRT initiation. A final exploratory analysis will describe cancer, CVD and mortality endpoints across 5 groups including users of different forms of oral combined HRT and those initiating tibolone as well as a group unexposed to HRT but with a menopause diagnosis. The latter group will be matched to HRT users on factors including age and practice. Kaplan-Meier curves in matched samples will describe the incidence of outcomes among the different groups.
This research will lead to a better understanding of the risk profile of different formulations of HRT and will facilitate informed decision making for the growing numbers of women who are seeking HRT for the alleviation of symptoms of oestrogen deficiency.
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Global Vaccine Data Network (GVDN) Project - A multi-centre international database study evaluating maternal and neonatal safety post COVID-19 vaccination in pregnant women — Debabrata Roy ...
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Global Vaccine Data Network (GVDN) Project - A multi-centre international database study evaluating maternal and neonatal safety post COVID-19 vaccination in pregnant women
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-25
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Alison Yeomans - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Denise Morris - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
The primary outcome to be measured will be the incidence of pre-specified core maternal, foetal, and neonatal health outcomes (please see appendix 1 for list of pre-specified outcomes) among women exposed to a COVID-19 vaccine vs. non-exposed women during pregnancy, according to vaccine type/dose/platform (i.e., nucleic acid-based and protein-based vaccines). Secondary outcomes will measure the incidence of these events (appendix 1) according to pregnancy characteristics, medical conditions, other vaccines received and other Adverse Events (AEs). Exploratory outcomes will measure the incidence and severity of COVID-19 infections in the population of interest.
Description: Lay Summary
Vaccination during pregnancy protects both the mother and baby from serious illness. In the UK multiple vaccines are recommended for used during pregnancy and given as part of routine care. The COVID-19 vaccines were the most recently approved vaccines to be used in pregnancy and were recommended from April 2021, although they were met with hesitancy due to the rapid rollout of these vaccines. COVID-19 vaccines were given emergency use authorisation and ongoing safety studies are required to monitor the safety in populations that were not eligible in clinical trials, such as pregnant women. Here we aim to study the safety of COVID-19 vaccination in the mother as well as the baby, we will investigate whether there is an increased risk of suffering a side effect, whether health outcomes of the pregnancy and baby differ as well as how well the vaccine protected against COVID-19 disease. This study will compare pregnant women who received a COVID-19 vaccine during their pregnancy against pregnant women who did not receive a COVID-19 vaccine. This study is part of a large international project that will bring together data regarding pregnancy and health outcomes in both mother and babies to provide a larger population to analyse, this will generate a clear picture of the safety and effectiveness of the vaccine.
Technical SummaryVaccination during pregnancy for multiple conditions, including COVID-19, is recommended to protect both mother and foetus(es). Vaccination results in high antibody titres in the mother that are capable of transplacental transport to the foetus(es), providing protection against infections during pregnancy and in the first few months of life when the neonatal immune system is immature. The recommendation for pregnant women to receive the COVID-19 vaccine was advised by the Joint Committee on Vaccination and Immunisation (JCVI) in the UK on 16 April 2021. Pregnant women are at higher risk of complications and severe COVID-19 disease, and real-world data from the United States demonstrated that there were no safety concerns in pregnant women. Consequently, four months after the emergency use approval of COVID-19 vaccines, pregnant women were eligible to receive the vaccines, in the UK. As pregnant women were excluded from clinical trials prior to this recommendation, there is a need to better understand the safety and efficacy of COVID-19 vaccination in pregnancy and the safety of the different vaccine platforms. Using a retrospective observational cohort study we will investigate the safety of COVID-19 vaccination in pregnant women and their neonates. The study will use the CPRD Aurum pregnancy register and mother-baby linkage to ascertain the population. Vaccination status and health outcomes will be determined using Aurum primary care records. Incidence rates and adjusted rate ratios for adverse events will be calculated for vaccinated and unvaccinated women within a defined risk window during pregnancy. CPRD ethnicity records and small area level data will be utilised to define covariates. These data will contribute to an international project to establish the safety and efficacy of COVID-19 vaccination in pregnant women and their neonates.
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Changes in heart failure medication prescribing patterns in real-world clinical practice between 2015-2023 — Daniala Weir ...
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Changes in heart failure medication prescribing patterns in real-world clinical practice between 2015-2023
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-11
Organisations:
Daniala Weir - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Bart Spaetgens - Collaborator - Maastricht University Medical Centre
Fatma Karapinar - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Johannes Nielen - Collaborator - Maastricht University Medical Centre
Maram Aldbiat - Collaborator - Utrecht UniversityOutcomes:
1. Incident prescriptions for separate HF medications including: ACEIs, ARBs, ARNIs, BBs, Diuretics, MRAs, SGLT2-Is within 3 months of HF diagnosis.
2. Number of HF medication classes prescribed in combination (5 separate classes: ACEIs/ARBs/ARNIs; BBs; Diuretics; MRAs, SGLT2-Is) within 3, 6 and 12 months of HF diagnosis.
3. Treatment persistence according to HF medication class within 6 and 12 months after HF diagnosis.Description: Lay Summary
Heart failure (HF) is a chronic condition where the heart is unable to pump blood efficiently, leading to insufficient blood flow to meet the body's needs. HF significantly impacts the quality of life, morbidity, and mortality of patients and imposes a substantial burden on the healthcare system. In 2014 the number of patients who were diagnosed with HF in the UK was 920,616. From 2015 until 2019 the number of new HF cases increased.
Technical Summary
In this study we will describe the utilization patterns of five most used drug classes of HF medications and the characteristics of the patients using them, such as age, gender, comorbidities, and other relevant factors. By understanding these patterns, we aim to provide insights into how these medications are being prescribed and used in real-world settings. For example, we will examine how many patients continue taking each medication, and how many patients use multiple HF medications which could help in optimizing treatment strategies, improving patient outcomes, and guiding future research and policy decisions related to heart failure management.The objective of our study is to describe changes in HF medication utilization patterns among patients with incident heart failure diagnosed between 2015 and 2023. We will conduct a descriptive retrospective cohort study of patients with incident HF (index date), aged 18 or older who are eligible for HES linkage using CPRD Aurum data. We will measure baseline demographics and comorbidities. We will consider the prescription of the following HF-medications within 3-months of incident HF diagnosis: ACEIs, ARBs, ARNIs, BBs, Diuretics, MRAs, SGLT2-Is. Combination therapy will be characterised according to medication class: ACEIs, ARBs, and ARNIs will be grouped together into one class and the remaining medications will represent a separate class, for a total of 5 HF medication classes. The number of unique HF medication classes prescribed to each patient within 3-months of index will be evaluated. We will measure persistence for each HF medication at 6- and 12-months following HF diagnosis. Non-persistence will be defined as a treatment gap for HF medications overall for up to 90 days.
Descriptive statistics will be used to describe the patient population and HF medication utilization. We will calculate the proportion of patients prescribed each HF medication class within 3-months of HF diagnosis, as well as per year. Additionally, we will describe patient characteristics at baseline according to the specific HF medication prescribed as well as according to the number of medication classes prescribed. We will also calculate the proportion of patients who were non-persistent to their HF therapy at 6-months and 12-months following index. This study will generate new, currently unavailable data on heart failure patient characteristics, prescription patterns, treatment adherence, and guideline implementation in the UK. These findings may help direct future research toward the most relevant issues and support healthcare providers in optimizing patient care.
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Analysis of electronic health records to obtain statistical parameters for health economic model of dementia prevention, diagnosis and care — Joseph Kwon ...
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Analysis of electronic health records to obtain statistical parameters for health economic model of dementia prevention, diagnosis and care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-25
Organisations:
Joseph Kwon - Chief Investigator - University of Oxford
Joseph Kwon - Corresponding Applicant - University of Oxford
Carmen Fierro Martinez - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Innocent Erone - Collaborator - University of Oxford
Jiamin Du - Collaborator - University of Oxford
Monserrat Guilherme Conde - Collaborator - University of Oxford
Olu Onyimadu - Collaborator - University of Oxford
Phuong Bich Tran - Collaborator - University of Oxford
Sam Creavin - Collaborator - University of Bristol
Smruti Bulsari - Collaborator - University of Oxford
Subhashisa Swain - Collaborator - University of Oxford
Sujin Kang - Collaborator - University of Oxford
Ting Cai - Collaborator - University of OxfordOutcomes:
(1) In Incidence cohort: dementia incidence by sociodemographic and clinical groups (e.g., age, sex, frailty); associations between incidence and hypertension, diabetes, depression, and preventive prescriptions.
(2) In Dementia cohort: indicators of standards of dementia diagnosis/care â time to dementia diagnosis from initial memory complaints; dementia severity at diagnosis measured by severity phenotype and frailty; time to anti-dementia prescription; trajectories of dementia severity post-diagnosis; variations by sociodemographic/clinical groups.
(3) In Dementia cohort: clinical and health economic consequences of dementia (absolute levels and relative to matched controls) â primary, secondary, palliative and residential care utilisation and cost; mortality; variations by sociodemographic/clinical groups.
Description: Lay Summary
Background: Dementia is a term for several diseases that affect memory, thinking, and ability to perform daily activities. It's important to prevent dementia, find it early, and help those living with it. Health officials need to figure out how to spend money wisely between prevention, diagnosis, and care. Investing heavily in services that diagnose dementia might help more people receive diagnosis but could mean less money for caring for them afterward. A computer-based model can simulate different ways of investing and see which have good value for money and reduce unfair health gaps. For that model to work well, we need data on how often dementia occurs, how itâs diagnosed, and care provided. Electronic health records connecting primary care, hospital and death records are excellent data sources.
Purpose: We will use the Clinical Practice Research Datalink (CPRD) Aurum dataset with connected hospital and death records to gather important data for a computer-based programme that can inform dementia policy. Weâll look at data that includes: (1) how common dementia is depending on things like age, gender, and conditions like high blood pressure; (2) how well we currently diagnose and care for dementia (like how long it takes for a doctor to diagnose dementia after spotting memory issues); and (3) the financial impact of dementia (like cost of hospital stays).
Importance: The computer programme will guide health officials in making decisions about dementia care. This can lead to better care for those with dementia and lessen the impact of dementia on society.
Technical SummaryAim: Health economic models can inform commissioning decisions spanning dementia prevention, diagnosis and care in terms of cost-effectiveness and health inequality reduction. This study aims to obtain statistical parameters for developing a health economic model of dementia intervention to inform policy.
Population: We will study two cohorts. (1) âIncidence cohortâ: UK population aged 45+ years without prevalent dementia in 2005-24, with 12+ months of registration and complete data linkage. (2) âDementia cohortâ: individuals aged 60+ years newly diagnosed with dementia in 2014-24, matched with controls by age, sex, GP practice and time in study. Subjects should have 12+ months of registration and complete data linkage (except for CPRD Aurum Ethnicity data).
Exposure(s) and outcome(s): Exposures for Incidence cohort are risk factors for dementia (e.g., hypertension) and preventive prescriptions (e.g., anti-hypertensive medications); exposure for Dementia cohort is dementia diagnosis. Three outcome categories are: (1) dementia incidence and association with risk factors; (2) standard of dementia diagnosis/care (e.g., time from GP referral to diagnosis); and (3) health economic consequences of dementia (e.g., hospitalisation cost) versus controls.
Data sources: CPRD Aurum; CPRD Aurum Ethnicity; ONS Death Registration; HES Admitted Patient Care, Outpatient, Accident and Emergency; Practice/Patient Level Index of Multiple Deprivation.
Study design: Prospective cohort analysis
Methods: Descriptive statistics will be reported. Kaplan-Meier and Cox proportional hazard models will be used to estimate associations between covariates and time-to-event variables, including dementia incidence and diagnosis, institutionalisation and mortality; maximum likelihood estimation will fit parametric distribution to time-to-event data. Generalised linear models will be used to estimation associations between covariates and health economic cost variables.
Public health benefit: The developed health economic model will inform commissioning decisions for dementia intervention. This can improve quality of care for people living with dementia and reduce health and social care cost of dementia, including burden on family caregivers.
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Vaccine uptake in adults with inflammatory conditions treated with immune suppressing drugs: a prospective study using data from the Clinical Practice Research Datalink (CPRD) — Georgina Nakafero ...
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Vaccine uptake in adults with inflammatory conditions treated with immune suppressing drugs: a prospective study using data from the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-25
Organisations:
Georgina Nakafero - Chief Investigator - University of Nottingham
Georgina Nakafero - Corresponding Applicant - University of Nottingham
Abhishek Abhishek - Collaborator - University of Nottingham
Edoardo Cipolletta - Collaborator - University of Nottingham
Jaspreet Kaur - Collaborator - University of Nottingham
Lisa Szatkowski - Collaborator - University of NottinghamOutcomes:
Administration of [1] SARS-CoV-2 vaccine, [2] IIV, [3] pneumococcal vaccine, and [4] varicella zoster vaccine against shingles.
Description: Lay Summary
One in 30 adults have an inflammatory condition such as rheumatoid arthritis. They are treated with medicines that suppress the immune-system and increase the risk of COVID-19, flu, pneumonia and shingles. This is why vaccination is central to protect their health and well-being. However, many people with these conditions do not get vaccinated. For instance, information from over 32,000 people with inflammatory conditions in the UK showed that only 67% took the third booster vaccination against COVID-19, 61% got vaccinated against influenza in the previous year, and only half had ever been vaccinated against pneumonia.
The COVID-19 pandemic that began in December 2019 affected vaccinations all over the world. The impact of this pandemic on vaccine uptake in people with inflammatory conditions is not known. Additionally, it is unclear what factors associate with not getting vaccinated among adults with inflammatory conditions. Our study will answer these questions.
We will use anonymous information from CPRD for this study. The proportion of the study population that received the vaccine of interest between 2005 and 2025 will be calculated. Vaccine uptake before and after the COVID-19 pandemic will be compared. Next, we will compare factors that influence vaccination between those who got and did not get vaccinated.
We will share our findings with patients, healthcare professionals, and policymakers.
Technical SummaryObjectives: To examine
⢠uptake of severe acute respiratory syndrome coronavirus 2 (SARSâCoVâ2) vaccine, influenza, pneumococcal and varicella zoster vaccines in immunosuppressed adults with inflammatory conditions (IMIDs) over the last 20 years,
⢠impact of the COVID-19 pandemic on the uptake of vaccination in adults with IMIDs
⢠factors associated with not getting vaccinated among adults with IMIDsMethods:
Data source: We will use data from the Clinical Practice Research Datalink (CPRD)-Aurum. Aurum is a longitudinal anonymised electronic database containing health records of over 50 million UK residents. It contains details of diagnoses, prescriptions, immunisations, and lifestyle factors.
Population: Adults with IMIDs including either rheumatoid arthritis, inflammatory bowel disease, and psoriasis +/- arthritis prescribed at least one immune-suppressing drug.
Outcomes:
Administration of [1] Inactivated influenza vaccine (IIV), [2] SARS-CoV-2 vaccine, [3] pneumococcal vaccine and [4] varicella zoster vaccine against shingles.
Data analysis: Vaccine uptake will be examined in a cross-sectional study. Proportion vaccinated in the latest year, regardless of type of vaccine, will be stratified by age (<45, 45â64, >=65 years), level of derivation, presence of other indications for vaccination, and types of inflammatory disease. Logistic regression will be used to examine mutually adjusted associations between age, sex, deprivation, region, ethnicity, IMID type, immune suppressing drugs, and vaccine uptake. Time series analysis will be used to assess the impact of COVID-19 pandemic on the uptake of vaccination in adults with IMID.
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Improving assessment of the risk of underlying cancer and non-neoplastic disease in primary care — Georgios Lyratzopoulos ...
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Improving assessment of the risk of underlying cancer and non-neoplastic disease in primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; NCRAS Tumour / Treatment data; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-25
Organisations:
Georgios Lyratzopoulos - Chief Investigator - University College London ( UCL )
Rebecca White - Corresponding Applicant - University College London ( UCL )
Amalie Pinderup - Collaborator - University College London ( UCL )
Angela Wood - Collaborator - University of Cambridge
Cristina Renzi - Collaborator - University College London ( UCL )
Emma Whitfield - Collaborator - University College London ( UCL )
Freya Pollington - Collaborator - University College London ( UCL )
Gary Abel - Collaborator - University of Exeter
Helen Fowler - Collaborator - University College London ( UCL )
Jeremy Stein - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Marta Berglund - Collaborator - University College London ( UCL )
Matthew Barclay - Collaborator - University College London ( UCL )
Meena Rafiq - Collaborator - University College London ( UCL )
Nadine Zakkak - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
Diagnoses of:
1) Cancer (all types combined, and specific types). Cancer types will be considered individually when common (e.g., breast, lung, colon, rectum, prostate, bladder, ovary, pancreas, kidney, endometrial, lymphoma, oesophageal, gastric, melanoma). Cancer types may be aggregated into broader groups when rarer (e.g. oesophageal and gastric cancer may be combined).
2) Symptomatically-similar non-neoplastic diseases for different cancers. Examples include:
Oesophageal/gastric cancer: Gastro-Oesophageal Reflux Disease, ulcer, diaphragmatic hernia.
Colo-rectal/ovarian cancer: Inflammatory Bowel Disease, Irritable Bowel Syndrome, diverticular disease, endometriosis
Lung cancer: COPD, asthma, heart disease, chest infections
Pancreatic cancer: diabetes, biliary diseases
Bladder/kidney cancer: Urinary Infections, Benign Prostate HyperplasiaDescription: Lay Summary
Many cancer patients are diagnosed with cancer at advanced disease stage or following emergency hospital admission, both associated with poor outcomes and patient experience. Most people with cancer will first present to their doctor with signs and symptoms that may be due to their cancer, but which could point to a range of diagnoses. New evidence that helps doctors identify which patients are most likely to have cancer or another serious disease so that they are referred and investigated promptly could lead to more patients being diagnosed early, when they are more likely to benefit from treatment.
To develop useful new evidence we will use primary care data on patient clinical events (including symptoms, prescriptions, and investigations) and other risk factors (age, sex, weight, smoking and alcohol status), producing statistical models that estimate the risk of cancer or other symptomatically-similar diseases in patients presenting in primary care. We will examine if these predictions vary by patient factors (including ethnicity, deprivation, co-morbidities, and geographic region) and tumour factors (including stage, grade and site). This information will help to update clinical guidelines, to support doctors when they decide whether to refer or investigate a patient for suspected cancer or other related illness, and will create tools that can be incorporated within primary or secondary care patient records systems to help diagnose patients with cancer.
Technical SummaryA significant proportion of cancers in the UK are diagnosed at a late stage or via emergency presentations - features associated with poor patient experience and outcomes. As most patients with cancer are diagnosed after presenting in primary care, research is needed to support more timely diagnosis of cancer in this setting.
Evidence is needed to support GPs in identifying which patients are at highest risk of having an as-yet undetected cancer, as opposed to another symptomatically similar disease, to prioritise them for referral or specialist investigations. More evidence is needed about:
⢠The risk of any cancer, and the most likely cancer sites, in symptomatic patients
⢠The risk of important conditions other than cancer in symptomatic patients
⢠Risk of cancer/other conditions in patients with non-specific signs or symptoms.Consideration of additional information in primary care electronic health records (EHRs) could improve primary care clinical triage and risk-stratification. We will perform a cohort study, including patients aged 30 years+ in English primary care between 2014-2024. We will use rich GP EHRs to calculate predictive values of different features for detecting cancer and a range of underlying diseases, and assess whether these predictions are enhanced by combining information from pre-diagnostic features (symptoms, prescriptions, investigations) and risk factors (smoking, age, sex, BMI).
We will develop diagnostic risk models that can directly inform clinical practice and guidelines for GPs, comparing both traditional statistical methods with innovative machine learning approaches that leverage the rich longitudinal nature of EHRs.Since the predictive value of risk predictors (e.g. symptom recording, investigation use) depends on their recording, we will examine whether their recording â and associated predictive performance of models- vary by patient or tumour factors (including ethnicity, socioeconomic status, co-morbidity status, geographic region, cancer stage and cancer site/disease type) and calendar period.
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Feasibility study to evaluate using the family number to link father and child records in CPRD GOLD — Romin Pajouheshnia ...
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Feasibility study to evaluate using the family number to link father and child records in CPRD GOLD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-07
Organisations:
Romin Pajouheshnia - Chief Investigator - RTI Health Solutions ( USA )
Katica Boric - Corresponding Applicant - RTI Health Solutions ( USA )
ALICIA ABELLAN - Collaborator - RTI Health Solutions ( USA )
Andrea Margulis - Collaborator - RTI Health Solutions ( USA )
Estel Plana Hortoneda - Collaborator - RTI Health Solutions ( USA )
Raquel Garcia Esteban - Collaborator - RTI Health Solutions ( USA )Outcomes:
The number of father-newborn pairs; proportion of newborns linked to a possible father.
Description: Lay Summary
There is growing need to investigate how medicines taken by men around the time of conceiving a child might affect the pregnancy and health of the child. Routinely collected patient data can provide an important source of information to investigate this. Clinical Practice Research Datalink (CPRD) currently has a mother-baby link algorithm, a method that connects anonymised maternal records to those of their liveborn children. While one prior study reported using the CPRD primary database (CPRD GOLD) to link child records to the records of both their mothers and potential fathers, a father-child link data set is not currently available for CPRD.
Technical Summary
This study aims to investigate the feasibility of linking child and paternal records using the CPRD GOLD database. We will apply approaches to link the anonymised records of newborn infants with the anonymised records of potential fathers. We will first select a group of newborn infants and a group of potential fathers in the period 2020 to 2024. Then, using the CPRD family number code and other criteria, we will connect pairs of child records and records of potential fathers and count how many pairs can be connected. This will provide information on the feasibility of using the family number code to develop a father-child link algorithm in a full study.
This feasibility study will benefit society by providing information to help design a future father-child link algorithm, which would support research into the use and safety of medicines by men around the time of conceiving a child.CPRD has a mother-baby link data set. While one study reported linking child records to the records of their mothers and potential fathers in CPRD GOLD, a father-child link dataset is not currently available.
We propose a feasibility study to investigate linkage of child records with the records of potential fathers in CPRD GOLD, to inform whether a full study to develop a father-child link algorithm is feasible. We aim to examine the specificity of the CPRD GOLD family number ID and investigate the number and proportion of newborns whose records can be linked to a possible fatherâs records using the family number ID, in particular fathers who are continuously enrolled at least 12 months prior to the newbornâs birth, as needed to assess paternal medication use around conception.
We will use the CPRD GOLD patient and practice datasets, and no linked data. The study will be cross-sectional, from 01 January 2020 to 31 December 2024. First, we will select newborns during the study period with practice registration within 1 year of birth. Second, we will select male patients aged 16-65 years during the study period. For each group, we will describe the distribution of the family number ID. Next, for each newborn, we will select possible fathers from the male patient group based on matching family number ID. We will apply additional restrictions to refine the linked pairs, based on GP practice ID, male age, and timing of GP registration, and describe the number of linked pairs. No exposures or outcomes will be assessed.
This feasibility study will benefit public health and society by providing information required to design a future father-child link algorithm, which would support research into the use and safety of medicines by men at the time of conception.
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Classifying and describing patient-related activities in primary medical services — Geraldine Clarke ...
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Classifying and describing patient-related activities in primary medical services
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-14
Organisations:
Geraldine Clarke - Chief Investigator - The Health Foundation
Elizabeth Crellin - Corresponding Applicant - The Health Foundation
Andrew Jones - Collaborator - NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT
Dasha Belokhvostova - Collaborator - The Health Foundation
Freya Tracey - Collaborator - The Health Foundation
Jonathan Clarke - Collaborator - The Health Foundation
Jonathan Spencer - Collaborator - NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT
Paul Seamer - Collaborator - NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT
Sarah Opie-Martin - Collaborator - The Health Foundation
Steven Wyatt - Collaborator - NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNITOutcomes:
Primary outcomes: Counts and proportions of patient-related activities by activity group, staff group, patient group, and year.
Primary care activity based on consultation events, clinical non-consultation events, and administrative events will be categorised into around 30 activity groups.
Patients will be categorised into 11 Patient Need Groups according to their clinical activities in primary and secondary care using the Johns Hopkins ACG system.
Differences in proportions of patient-related activities by activity group, staff group, patient need group, and year between practices according to rurality, socioeconomic deprivation of practice population and an indicator of Modern General Practice will also be calculated.
Description: Lay Summary
There are about 7000 General Practitioner (GP) practices in England. These practices vary in size, the populations they serve, the types of staff that they employ, and how they allocate tasks to their staff. This leads to differences in the services that patients receive.
Some of these differences may reflect practices tailoring services to their local population, or National Health Service (NHS) guidance, while other differences may indicate unnecessary variation in quality or efficiency. The NHS is keen to reduce unnecessary variation and help GP practices provide consistent standards of care for the public, but does not have a clear understanding of which types of staff are providing care, the different patient groups demanding care, or the demand for different types of care.
In this project, we will summarise information from Clinical Practice Research Datalink (CPRD) Aurum about the activities being performed in primary care, along with the staff roles and broad clinical group of the patients involved. This will allow us to understand how the allocation of staff to tasks varies over time and between practices according to, for example, whether they are in an area with more deprivation or in more rural areas.
We will use the findings of this project to benefit public health by working closely with NHS England to help them understand how to use their existing primary care staff best and to indicate where changes to staffing may be needed. This will help the NHS provide better care to patients and improve public health.
Technical SummaryReducing unwarranted variation in General Practitioner (GP) services is a high priority for policy makers, but designing effective policy interventions requires an understanding of how care is already delivered. This project aims to describe primary care activity according to high-level activity groups, patient groups and staff groups and how this varies between types of practices.
Study population of interest: Patients receiving primary care in England from 2013-2024.
Primary outcome(s): The count and proportion of activity recorded in each activity group, staff group and patient need group. Specific combinations of these will be examined in more detail.
Study design: Descriptive study
Data sources: CPRD Aurum, Hospital Episode Statistics (to classify patient need), patient Index of Multiple Deprivation and practice Rural/Urban classification (to examine variation by practice characteristics).
Methods:
This project will produce summary descriptive statistics from CPRD Aurum by:
1. classifying patient-related activities from consultation events, clinical non-consultation events, and administrative events into around 30 categories
2. classifying patients according to their needs using the Johns Hopkins ACG tool
3. classifying staff by role type
4. calculating the frequency of classes of patient-related activity (point 1) for each class of patient (point 2) and staff (point 3)
5. constructing a âModern General Practiceâ indicator to classify practices as Modern General Practice based on their use of different consultation events. Modern General Practice is a recently introduced NHS England policy.
6. stratification of point 4 by practice characteristics including deprivation, rurality and the indicator of âModern General Practiceâ.We will explore the use of published classification systems, and develop new classification methods as required. All outputs will be subject to statistical disclosure control.
Analysis will primarily involve descriptive statistics, but may also include measures of correlation, and simple statistical tests.
Findings from this cross-sectional description will inform NHS England primary care policy.
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Prevalence of switching in endocrine therapy among patients with breast cancer, and the risk of adverse events and treatment discontinuation — Pinkie Chambers ...
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Prevalence of switching in endocrine therapy among patients with breast cancer, and the risk of adverse events and treatment discontinuation
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-14
Organisations:
Pinkie Chambers - Chief Investigator - University College London ( UCL )
Chengsheng Ju - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )
Rebecca Todd - Collaborator - University College London ( UCL )
Zoe Moon - Collaborator - University College London ( UCL )Outcomes:
1. Switching to another endocrine treatment type or brands.
2. Discontinuation of endocrine treatment.
3. Adverse events associated with endocrine treatment, including depression, anxiety, insomnia, fatigue, weight gain, musculoskeletal complications, vasomotor symptoms, and cardiovascular events.Description: Lay Summary
Hormone therapy is an important treatment for many women with breast cancer. It helps stop the cancer from coming back, and in the UK, around 38,500 women are given this treatment every year. Women usually need to take hormone therapy for five to ten years, but research shows that only about half of them take it for as long as they should. Stopping too soon can increase the risk of the cancer returning and shorten lives.
One of the main reasons women stop taking their medication is because of side effects like hot flushes, muscle pain, weight gain, and tiredness. There are different brands of hormone therapy, and some women find certain brands harder to tolerate. Some doctors and patients believe that switching to a different brand might help with side effects, but we donât know how often this happens or whether it makes a real difference.
This study will use information from healthcare records to find out how often women change their hormone therapy, whether some groups of women are more likely to switch than others, and whether switching leads to fewer side effects and helps them stay on treatment for longer. If switching brands helps more women complete their treatment, it could mean better health, fewer cancer recurrences, and longer lives. Our findings could also help doctors and policymakers ensure women have access to the best options for them.
Technical SummaryAdjuvant endocrine therapy (AET) is a cornerstone in the management of hormone-sensitive breast cancer, prescribed to approximately 38,500 women in the UK annually. However, non-adherence and discontinuation rates remain high, with only 50% completing the five-year treatment course. Common adverse events (AEs) such as hot flushes, joint pain, and fatigue are major contributors to poor adherence and treatment discontinuation.
This study utilises a population-based cohort of patients with breast cancer receiving AET, extracted from the CPRD GOLD and Aurum, linked to HES, ONS Death Registration, and cancer registry data. Eligible patients will be women who were diagnosed with breast cancer (including metastatic breast cancer) between 2011 and 2018, and initiated any AET products. All patients can be followed up until March 2021. We will examine patterns of treatment switching and discontinuation, focusing on switching between tamoxifen and aromatase inhibitors, among different aromatase inhibitors, and between brands. Kaplan-Meier curves will be used to illustrate the patterns of treatment change. Cox proportional hazard models will be used to compare the rate of treatment change between patient groups, e.g., ethnicity, socioeconomic status, tumour characteristics, and age.
We will then explore the association between treatment switching and the risk of AEs (including depression, anxiety, insomnia, fatigue, weight gain, musculoskeletal complications, vasomotor symptoms, and cardiovascular events) and adherence, comparing these outcomes across key subgroups by age, ethnicity, socioeconomic status, and comorbidity profiles. The analysis employs a prevalent new user design for examining treatment switching and discontinuation to minimise confounding in comparisons of switching versus continuing treatment. The findings aim to identify modifiable factors influencing AET adherence and discontinuation, addressing a gap in evidence regarding the real-world impact of treatment switching on AEs and adherence.
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The effect of bariatric surgery upon long-term survival in high-risk cardiovascular patients — Sheraz Markar ...
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The effect of bariatric surgery upon long-term survival in high-risk cardiovascular patients
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-26
Organisations:
Sheraz Markar - Chief Investigator - University of Oxford
Wing Kiu Chou - Corresponding Applicant - University of Oxford
Aden Kwok - Collaborator - University of Oxford
Eva Morris - Collaborator - University of Oxford
Raph Goldacre - Collaborator - University of OxfordOutcomes:
Primary outcome: All-cause mortality;
Secondary outcomes: Cardiovascular events requiring hospital admission; Cerebrovascular events requiring hospital admission; Temporal changes to BMI/weight; All-cause hospitalisation;Description: Lay Summary
In 2022, it is estimated that 1 in 8 people in the world are living with obesity. Globally, obesity has more than doubled in the last twenty years and more than quadrupled in adolescents. Obesity is among the leading causes of death and disability in people with existing cardiovascular disease which can lead to strokes, heart attacks and blood vessel disease. It is estimated that half of people with cardiovascular diseases (CVD) are obese and it is projected that these individuals are at significant higher risk of having stroke, heart attacks and blood vessel disease. The healthcare costs related to obesity are staggering, with an estimated global cost of US$990 billion per year.
Technical Summary
Bariatric surgery (commonly known as weight loss surgery) is the most effective method of achieving long term weight loss. Researchers from Sweden and Canada have suggested that bariatric surgery can be effective in reducing death and complications of heart diseases but there lacks evidence to suggest similar findings in the UK. We aim to study the effectiveness of bariatric surgery in prolonging life and reducing long-term cardiovascular events in a nationwide study in the UK.In this study we aim to investigate the effect of bariatric surgery on long term survival in high-risk cardiovascular disease patients. The overarching aims of this work is the demonstrate the efficacy of bariatric surgery versus conservative management in obese individuals with high risk CVD. Our study population are individuals who are obese adults and have high risk CVD as defined as the presence of any one of the following: ischaemic heart disease, cardiac failure, atrial fibrillation or cardiac arrythmia, cerebrovascular disease and peripheral artery disease. The primary exposure in this study will be bariatric surgery. Our primary outcome is all-cause mortality with secondary endpoints being hospitalization for cardiovascular events, cerebrovascular events and temporal changes in weight. The recruitment period will be between 2002 and until latest linkage. The follow up period will be final day of the study period or death, whichever occurred first. Study period is from the index bariatric surgery to the final day of the study period or death.
Linkage to HES from CPRD data will be required to determine the aforementioned events. Linkage to ONS Mortality data will also be required to determine cause and date of death. In this retrospective observational cohort study, propensity scores will be calculated with adjusted logistic regression predicting the dependent variable of bariatric surgery or not. Patients who underwent bariatric surgery (exposed group) will be matched with a comparison subject (unexposed group). Kaplan-Meier plots will be use to visually compare survival. Log rank test will be used to compare both groups. Cox proportional hazards regression model will be used to determine relative risk of overall mortality over time. The benefits of this work are to clarify effectiveness of bariatric surgery this will allow for clinicians to make better informed decisions about management of patients who are obese.
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The impact of living alone with dementia in health care service usage and costs: a matched cohort study — Jose Leal ...
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The impact of living alone with dementia in health care service usage and costs: a matched cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-21
Organisations:
Jose Leal - Chief Investigator - University of Oxford
Miriam Lúcar Flores - Corresponding Applicant - University of Oxford
Filipa Landeiro - Collaborator - University of OxfordOutcomes:
Primary outcomes are healthcare resource usage (primary care: registers for visits with general practitioners and practice nurses in healthcare facilities or at patients' homes and drug prescriptions; secondary care: admitted patient care outpatient records, accident and emergency records and critical care) as well as their and associated costs.
Secondary outcomes will explore age, sex, ethnicity, comorbidities, socio-economic groups, and mortality to identify if resource usage and costs vary between cases and controls.
Description: Lay Summary
Dementia is a health condition that causes progressive and incremental brain function problems that reduce the ability of a person to carry out daily activities and be independent. In 2019, the cost of dementia in the United Kingdom (UK) was £34.7 billion, mostly due to social care and unpaid support. By 2050, this number could reach up to £102 billion. Dementia affects many people, and its costs are very high. But we still do not know how these costs and impacts vary across different groups. Currently, about 120,000 people with dementia in the UK live alone, and this number could double by 2039. People with dementia living alone often feel lonelier and interact less with others. Also, they report being less satisfied with their lives. About health services use, they need more at home care and technological support. Also, they are at a higher risk of needing to move into a nursing home as their condition worsens. Despite this, there isnât much information on how much this care costs for people in this group. Our study will analyse how living alone affects healthcare needs and costs for people with dementia. This knowledge can help with resource allocation and create targeted services for this group.
Technical SummaryAlthough dementia affects many people, we still do not know how these costs vary across groups. About 120,000 people are living alone with dementia (PLAWD) in the UK, yet research on this group remains limited. This study aims to assess the impact of living alone on health resource usage and its associated costs on PWD living in the community.
To assess healthcare usage in primary care, we will utilise CPRD Aurum records. Secondary care data will be collected from the Hospital Episode Statistic (HES) dataset, and linked mortality records will be collected from the Hospital Episode Statistic-Office for National Statistics (HES-ONS) dataset. For a detailed characterisation of PLAWD, we will request patient-level data from the Small Area-Level Data linked dataset (SES) and the CPRD Aurum Ethnicity Record. The study period will be from the 1st of January 2010 to the latest date of available data. We will undertake a matched cohort study to categorise participants in the exposed group (living alone) or the unexposed group (living with others).
We will use propensity score methods to balance the two groups and allow meaningful comparisons. To quantify differences in healthcare resource usage and costs, we will use multivariable regression models such as Generalised Linear Models (GLMs). Additionally, we will also apply Kaplan-Meier sampling average methods to estimate mean costs between groups over 1 year or longer to account for censoring due to incomplete follow-up. To evaluate the differences in all-cause mortality and admission to care homes we will use Cox proportional hazards models to estimate hazard ratios for PLAWD compared to those living with others. Control variables will be included to adjust for confounding factors.
The study intends to inform public health decisions to foster the creation of more targeted and cost-effective support strategies for this vulnerable population.
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The Effect of Weight-lowering Drugs Versus Lifestyle Modifications on Fertility in Obese Women: A Population-based Cohort Study — Ruth Brauer ...
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The Effect of Weight-lowering Drugs Versus Lifestyle Modifications on Fertility in Obese Women: A Population-based Cohort Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-18
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Shaikha Alnaimi - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Kirsten Harvey - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )Outcomes:
In women with recorded BMI>27.5 kg/m2 (threshold for prescribing orlistat), the below objectives will be compared between the exposure group (women who received weight-lowering drugs ) and the comparators (women who received lifestyle modification advice).
Primary outcome (analytical)
To describe and compare the annual incidence rates of pregnancy in obese women of childbearing age (18-45 years) stratified by weight-lowering drug use (yes/no).
Secondary outcomes (descriptive):
- Adverse pregnancy outcomes (gestational diabetes, hypertensive disorders of pregnancy and venous thromboembolism).
- Perinatal outcome (live birth, preterm birth, stillbirth, pregnancy loss).Description: Lay Summary
Obesity is a major worldwide health problem defined by the World Health Organization (WHO) as having excessive body fat with the potential to have a negative effect on health, including reduced female fertility. Therefore, weight loss is recommended for obese women wishing to fall pregnant.
Technical Summary
A group of medications such as orlistat and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can be used as weight-lowering treatment. Besides their effects on weight, weight-lowering drugs are thought to improve female fertility, however, this is yet to be confirmed in large studies.
To address this gap in knowledge, we plan to conduct a study using the Clinical Practice Research Datalink (CPRD Aurum) data. This study will investigate the relationship between weight-lowering drug use and pregnancy rates. Specifically, we will compare the number of pregnancies in weight-lowering drug users and those who received advice on lifestyle changes for weight loss. We will also describe the potential effect of treatment for obesity on pregnancy and delivery. Our findings will be crucial to inform our understanding of the current role weight-lowering drugs play in female fertility and their impact on pregnancy and childbirth using real-world data.Obesity is a chronic disease with an estimated 26.2% of adults living with obesity in England. Adult obesity is associated with various cardiovascular, metabolic and endocrine complications. Another common consequence is female infertility, as excess fat can impact sex hormone levels, ovulation and menstrual cyclicity. As a first line non-pharmacologic approach, clinical guidelines recommend weight reduction with diet and exercise for women wishing to conceive. Pharmacologic or surgical intervention are reserved to patients who are not able to achieve the desired weight loss with lifestyle modifications alone. Orlistat and glucagon-like peptide-1 receptor agonists (GLP-1 RA) are recommended by the National Institute for Health and Care Excellence (NICE) treatment guidelines for patients with obesity. Beyond weight loss and glucose lowering effects, weight-lowering drugs may enhance female fertility, as suggested by results of recent animal studies and small human clinical trials. The available data is limited to small samples. Therefore, in this study we aim to investigate the relationship between weight-lowering drugs and pregnancy incidence rates. Using Clinical Practice Research Datalink (Aurum) data, we aim to follow a cohort of obese women. Firstly, we will measure and compare the pregnancy rates of women prescribed two types of weight-lowering drugs (two exposed groups) and those who received lifestyle modification advice (comparison group). Propensity scores will be used to account for potential confounding, and several sensitivity analyses will be conducted to assess the generalizability of our results. Secondly, in obese women who fall pregnant, we aim to describe the rate of adverse pregnancy outcomes (gestational diabetes, hypertensive disorders of pregnancy, venous thromboembolism) and perinatal outcomes (live birth, stillbirth, preterm delivery, pregnancy loss). Findings of this study are anticipated to provide an insight to the currently limited data on the role of weight-lowering drugs in female fertility.
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Understanding the link between kidney health and pregnancy outcomes — Kate Birnie ...
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Understanding the link between kidney health and pregnancy outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Ethnicity Record; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-26
Organisations:
Kate Birnie - Chief Investigator - University of Bristol
Kate Birnie - Corresponding Applicant - University of Bristol
Abigail Fraser - Collaborator - University of Bristol
Aws Sadik - Collaborator - University of Bristol
Fergus Caskey - Collaborator - University of Bristol
Maria Theresa Redaniel - Collaborator - National Cancer Registry - IrelandOutcomes:
Serum creatinine (sCr); estimated glomerular filtration rate (eGFR); urine albumin-to-creatinine ratio (UACR); urine protein-to-creatinine ratio (UPCR); CKD; cystatin C.
Description: Lay Summary
A woman's reproductive health is vital for her overall well-being and can provide clues about future health risks. Complications during pregnancy, such as high blood pressure (preeclampsia) and high blood sugar (diabetes) during pregnancy, can increase the risk of heart disease later in life. However, it is less clear if these complications also raise the chance of long-term kidney problems. Our study will explore whether pregnancy complications are linked to chronic kidney disease. This could help identify women who need closer health monitoring after pregnancy, as kidney disease can often be prevented or better managed when detected early.
Women with existing kidney problems may also face higher risks of pregnancy complications, but more research is needed to understand this connection. We will examine kidney health before pregnancy in women with diabetes to see if those with lower kidney function face a higher risk of issues like preeclampsia. This research is important as more women are having children later in life, making it essential to understand how health conditions affect pregnancy outcomes.
Finally, doctors use a blood test called creatinine to check kidney health during pregnancy, but normal levels for pregnant women are not clearly defined. We will compare kidney health in women with and without pregnancy complications and review data from multiple studies to establish healthy creatinine levels during pregnancy. Additionally, we will examine an alternative biomarker of kidney function, cystatin C, where measured. This work could help doctors better care for pregnant women.
Technical SummaryReproductive and obstetric health are important to a woman's overall well-being and are increasingly recognised as sex-specific predictors of chronic disease in later life. Adverse pregnancy outcomes (APOs), including pre-eclampsia, gestational hypertension, gestational diabetes and preterm delivery are associated with greater future cardiovascular disease. However, less is known about the long-term risk of chronic kidney disease (CKD) in women who have experienced APOs. We will use electronic health records to investigate if APOs are associated with greater CKD risk later in life, using Kaplan-Meier curves, Cox proportional hazards models and log-rank tests.
The risk of some APOs is increased in women with CKD. However, less is known about the risk of APOs in women with moderate or mild kidney impairment. We will use covariate-adjusted multi-level models to compare trajectories of kidney health (estimated glomerular filtration rate and urine albumin/ protein) by APO, in women with preexisting diabetes, from before to after pregnancy. We will plot predicted mean levels of kidney health and 95% confidence intervals for women with and without each APO. This comparison will help determine whether differences in kidney health are present before pregnancy or emerge post-pregnancy.
Serum creatinine concentration is recommended for assessing kidney function in pregnancy, but a normal range is not established. We will compare kidney function levels in women with and without pregnancy complications and preexisting health conditions. We will use systematic review techniques to calculate a reference range for creatinine in pregnancy, as well as for an alternative biomarker of kidney function, cystatin C, where measured.
This work has the potential to inform preventive strategies for APOs, and for CKD in later life. This is important because CKD is preventable and has a better prognosis if treated earlier. It is also costly to health services, especially if it develops into end-stage kidney disease.
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Investigating the changing prevalence of fibrotic multimorbidity in England — Jennifer Quint ...
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Investigating the changing prevalence of fibrotic multimorbidity in England
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Georgie Massen - Corresponding Applicant - Imperial College London
Gisli Jenkins - Collaborator - Imperial College London
Iain Stewart - Collaborator - Imperial College London
Louise Wain - Collaborator - University of LeicesterOutcomes:
Prevalence of fibrotic disease s and fibrotic multimorbidity between the years 2012 and 2022.
Description: Lay Summary
Fibrotic diseases cause organ scarring, damaging the affected organ and decreasing its ability to function,
Technical Summary
eventually leading to organ failure. Furthermore, patients can suffer from multiple fibrotic diseases, and this is called fibrotic multimorbidity.
An initial analysis of healthcare data found that 6% of UK adults have fibrotic multimorbidity but this area is poorly studied. We now look to understand how many people have multiple fibrotic conditions in England and how this number has changed over time from 2012-2022. We will measure how common fibrotic multimorbidity is in people each year and compare this measure (known as prevalence) year on year from 2012 to 2022 to understand if the proportion of people with fibrotic multimorbidity has increased or decreased or remained stable over this time period.
This is an important study as it will be the first study aiming to understand how the percentage of people with fibrotic multimorbidity has changed over time. This will help with NHS service planning as it will improve understanding of the scale of fibrotic multimorbidity and will therefore provide new evidence.Fibrotic conditions are characterised by excessive, uncontrolled deposition of extracellular matrix in the effected site, which alters the tissueâs extracellular environment, leading to organ
failure. There is still a large gap in the understanding of the aetiology of fibrotic diseases and the pathways by which they occur. Fibrotic multi-morbidity is defined as the simultaneous occurrence of more than one fibrotic condition in a patient.
Using a random sample of 1 million people, we calculated the point prevalence of fibrotic multimorbidity on the 1st of January 2015 as being 6%. Since this study we have further understood the strength of associations between common chronic conditions which were defined as being sometimes fibrotic and always fibrotic conditions. It was shown that hypertension and diabetes mellitus are more likely to be associated with fibrotic conditions and to themselves be considered fibrotic when they are poorly controlled or more severe.
We will use Aurum data linked with HES to calculate the annual period prevalence of fibrotic multimorbidity between 2012 and 2022. The denominator file will be used to calculate the number of people at risk of fibrotic multimorbidity who satisfy study inclusion criteria. We will study multi-organ fibrosis, to identify which organs commonly experience fibrosis alongside each other. We will further stratify analysis by age, sex and region to understand whether variations are present.
This is an important study as it will be the first study aiming to understand how the percentage of people with fibrotic multimorbidity has changed over time. Therefore, this will benefit the public and the NHS by informing service provision By calculating the prevalence of fibrotic multimorbidity and how this has changed over time, this work will benefit the general public as the information can be used by the NHS to better guide service provision, therefore improving care.
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The CANNON Study: Estimating the proportion of chronic obstructive pulmonary disease patients with chronic bronchitis and understanding their current disease burden in England: A study utilising primary and secondary care datasets. — Jay Were ...
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The CANNON Study: Estimating the proportion of chronic obstructive pulmonary disease patients with chronic bronchitis and understanding their current disease burden in England: A study utilising primary and secondary care datasets.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-18
Organisations:
Jay Were - Chief Investigator - Parexel International Limited (UK)
Jay Were - Corresponding Applicant - Parexel International Limited (UK)
Sariga Kakkamani - Collaborator - Parexel International Limited (UK)
Xinyu Yang - Collaborator - Parexel International Limited (UK)Outcomes:
Primary outcomes: Prevalence of COPD; COPD with chronic bronchitis/ and emphysema, comorbidities; Demographics (age, gender, follow-up and geographical region); Clinical characteristics (BMI, Charlson co-morbidity score, lung function, smoking status, history of vaccinations, frequency of exacerbations); Clinical outcomes (referrals, disease presentation and management (COPD assessment scores, atopy)
Secondary outcomes: treatment pathway(prescriptions issued in primary care, number of patients needing medication including inhaled therapies); Exacerbations (annual exacerbation rate); Mortality (Overall and COPD associated); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation)Description: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic lung disease characterised by airflow obstruction and symptoms such as breathlessness, persistent cough or sputum production.
Technical Summary
A common feature of COPD is an underlying degree of airways inflammation. COPD is a very diverse disease hence the nature and severity of this inflammation might differ between COPD patients depending on nature of the disease. As a result, anti-inflammatory treatments are unlikely to be effective in all patients. A precision medicine approach is needed to selectively target patients to increase the chance of therapeutic success.
It is therefore important to recognise COPD patient characteristics and the nature of their disease to guide treatment options in order to improve responsiveness to medication.
This study aims to determine the size of the population group with COPD in England and categorise it based on presence of chronic inflamed airways, severity and frequency of worsening symptoms. We shall then describe each group by its demographic and clinical profile, treatment prescribed and then determine health care resource use and costs associated with each group of patients.
This study will be able to provide an in-depth understanding of the demographic and clinical characteristics of this patient group, whilst also assessing the benefit of certain type of prescriptions in each cohort of COPD patients. This will trigger further research and inform health policy, treatment and clinical management options, especially targeting patients with specific risk factors in turn enabling better outcomes and reducing costs and healthcare resource usage associated with COPD.COPD usually develops because of long-term damage to your lungs from breathing in a harmful substance, usually cigarette smoke, and air pollution due to dust, fumes and chemicals.
A common feature of COPD is an underlying degree of airways inflammation. The nature and severity of this inflammation might differ between COPD patients depending on disease phenotype and pharmacological anti-inflammatory treatments are unlikely to be effective in all patients.
A precision medicine approach is needed to selectively target patients to increase the chance of therapeutic success. Inhibitors of the phosphodiesterase 4 (PDE4) enzyme like the oral PDE4 inhibitor roflumilast have shown a potential to reduce inflammatory-mediated processes and the frequency of exacerbations in certain groups of COPD patients with a chronic bronchitis phenotype. Therefore, understanding COPD patients relative to their disease phenotype is imperative.
This will be a descriptive study aiming to estimate the proportion of COPD patients, determine those with chronic bronchitis including mixed phenotype such as chronic bronchitis plus emphysema and to understand their socio-demographic profile and current disease. The study design has been chosen as this is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data.
We shall describe the cohort and subgroup in terms of patient demographic characteristics, prevalence of comorbidities, treatment pathway and clinical outcomes. From HES, health care resource usage (HCRU) including; inpatient admissions, outpatient appointments, A&E attendances and costs will be estimated using the HRG grouper software. From CPRD; primary care appointments and costs using PSSRU, tests and prescriptions will be estimated. This will trigger further research and inform health policy, treatment and clinical management options, especially targeting patients with specific risk factors in turn enabling better outcomes and reducing costs and HCRU associated with COPD.
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Evaluation of predictors, clinical pathways and outcomes in self-harm to provide Knowledge Support to support clinicians to manage self-harm and preventing suicide in primary care — Tjeerd van Staa ...
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Evaluation of predictors, clinical pathways and outcomes in self-harm to provide Knowledge Support to support clinicians to manage self-harm and preventing suicide in primary care
Datasets:GP data, CPRD Aurum Ethnicity Record; HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Tjeerd van Staa - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Faraz Mughal - Collaborator - Keele UniversityOutcomes:
The primary outcomes of interest will be emergency hospital admissions as recorded in the Hospital Episode Statistics (HES), A&E attendance and suicide (as recorded in the GP EHRs or ONS death certificates. Dates of A&E attendance will also be noted. Secondary outcomes of interest will include the distribution of admission and discharge ICD diagnoses as recorded in HES.
Description: Lay Summary
Self-harm is when someone intentionally inflicts harm on themselves. The rate of people who self-harm is increasing, but availability of services to help support these patients is not. For many people who have self-harmed, General Practitioners (GPs) act as the first point-of-contact and play an important role in supporting patients. Despite this, patient experience of GP services is often poor: patients are given few options for help outside of consultation and often leave their GP practice feeling uncertain of how to get the help they so desperately need. GPs are often not aware of how best to care for patients and have reported a lack confidence in managing patients who have self-harmed. Research has highlighted the need for GPs to better signpost to resources and provide patients with tailored care, and for medicines to be better monitored and communicated about. However, few tools exist to help with this. Tools which improve services at the GP-level may help prevent many painful experiences for patients later on. There is research to suggest that âknowledge supportâ tools may improve GP services. These are tools which aim to improve the knowledge of clinicians, patients and carers by providing them with personalised information during or outside of consultations. This proposed work is part of an ongoing research project in which we want to better understand how knowledge tools can meet clinician/patient needs. The aim of this proposed work is to better understand the predictors, clinical pathways and outcomes in patients who self-harm.
Technical SummarySelf-harm has been recognised as a major public health concern, with studies indicating increasing rates over time without a corresponding increase in support service utilisation. Primary care is often the first point of contact for patients who have self-harmed. The Adult Psychiatric Morbidly Survey suggested that more people sought care from their GP after self-harm than emergency or mental health services Due to the low rate of referrals to mental health aftercare (particularly in deprived areas), as well as the poor and infrequent conducting of psychosocial assessments (despite recommendations by the National Institute for Health and Care Excellence), patients remain managed by their General Practitioner (GP) Novel collaborative research evaluating digital support systems interventions to improve GP services are urgently needed for patients and healthcare staff.
The overall objective of this study is to inform approaches to better inform GPs during consultation about self-harm management. Specific aims of this study include to describe the characteristics of patients who self-harm, risks and predictors of adverse outcomes such as suicide and explore the presence of patient subgroups with specific clinical pathways. This study type will be a cohort study with nested case-control studies and be hypothesis generating. The primary outcomes of interest will be emergency hospital admissions, suicide and A&E attendance. The main exposures of interest will be medical histories and medication use. Unconditional logistic regression will compare the odds of exposures in cases to matched controls. Other analyses restricting to the patients who have self-harmed will evaluate patterns and clustering of prescribing and clinical record events over time including changes over time. This may include methods such as group-based trajectory modelling. Statistical analysis will explore the characteristics of each trajectory and estimate the association between different trajectories and hospital admission This study is part of a NIHR-funded Programme Development Grant.
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Is blood eosinophil count a risk factor for development of airways disease in later life? A matched case-control study. — Helen Ashdown ...
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Is blood eosinophil count a risk factor for development of airways disease in later life? A matched case-control study.
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-19
Organisations:
Helen Ashdown - Chief Investigator - University of Oxford
Helen Ashdown - Corresponding Applicant - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Francess Adlard - Collaborator - University of Oxford
Katja Maurer - Collaborator - University of Oxford
Laura Stirling-Barros - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of OxfordOutcomes:
As this is a case-control study, the outcome is the development of the disease, and we are assessing co-variates as risk factors for this outcome, particularly blood eosinophil count.
Primary outcome (development of disease of interest): diagnosis of airways disease at aged 40 or above (cases) compared with those who have never had a diagnosis of airways disease (controls)
Description: Lay Summary
Airways disease, which includes asthma and chronic obstructive pulmonary disease (COPD), can cause cough, breathlessness and flare-ups which can be serious, including causing death. COPD and late-onset asthma (which if poorly controlled can cause lung damage) are often only diagnosed late in life when the lung may already have been damaged. We are trying to find a way to find out which people are more likely to develop airways disease in future.
Previous research has shown that higher levels of a type of blood cell (called âeosinophilsâ) are linked with worsening lung function over time. But no studies so far have looked at whether higher levels of blood eosinophils in earlier life can predict whether someone will develop airways disease in later life.
We will find patients in the Clinical Practice Research Datalink who are diagnosed with late-onset airways disease, and âmatchâ them to other similar patients who do not have airways disease. We will then compare their blood eosinophil levels during their earlier life to see if there is a difference between groups, how this relates to other characteristics, and how blood eosinophil levels change over the years before they develop airways disease.
This research would benefit patients because if we can look for patients with this blood marker before they develop any symptoms (screening), we might be able to start treatments earlier which could prevent them from developing the disease and reduce lung damage and symptoms.
Technical SummaryAirways disease in later life (late-onset asthma and COPD) is often diagnosed late when significant lung damage has occurred. Little progress has been made in prevention of airways disease through identification of early and modifiable âtreatable traitsâ that may pose risk. Blood eosinophil count is a âtreatable traitâ which is elevated in airways disease and has been linked with lung function decline. However, little research has been done in primary care, where most airways disease is diagnosed and managed.
We plan to:
1) test the hypothesis that there is an association between blood eosinophil count in early life with the development of clinical airways disease in later adulthood
2) identify other epidemiological factors that individually contribute to risk and might affect the association between blood eosinophil count and the development of airways disease
3) describe how blood eosinophil count changes over the years prior to airways disease diagnosisWe will conduct a retrospective matched case-control study in CPRD Aurum linked to ethnicity and IMD data. Cases have a new diagnosis of airways disease at â¥40 years old matched with controls (by age, sex and timing of historical blood eosinophil count) without an airways disease diagnosis. Case and control groups will be compared using multivariate conditional logistic regression, particularly examining historical blood eosinophil count and its relationship to development of airways disease. We will assess stability of blood eosinophil counts and their different trajectories over time prior to airways disease diagnosis. Subgroup and sensitivity analysis will explore different ways of categorising historical blood eosinophil counts, and definitions of airways disease.
Identification of blood eosinophils as an early marker for airway inflammation would provide a screening target to identify those at risk of late-onset airways disease, and the potential to prevent or delay progression, minimising disease activity and lung damage.
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Investigating deprivation-specific and ethnic inequalities in adherence to endocrine therapy in women with oestrogen receptor positive breast cancer: can these explain disparities in survival? — Laura Woods ...
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Investigating deprivation-specific and ethnic inequalities in adherence to endocrine therapy in women with oestrogen receptor positive breast cancer: can these explain disparities in survival?
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; NCRAS Tumour / Treatment data; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-04
Organisations:
Laura Woods - Chief Investigator - Newcastle University
Laura Woods - Corresponding Applicant - Newcastle University
Adam Todd - Collaborator - Newcastle University
Brian Nicholson - Collaborator - University of Oxford
Caitriona Cahir - Collaborator - Royal College of Surgeons-Ireland
Eila Watson - Collaborator - Oxford Brookes University
Jonathan Pratschke - Collaborator - University of Naples Federico II
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Linda Sharp - Collaborator - Newcastle University
Peipei Liu - Collaborator - Newcastle University
Rohini Mathur - Collaborator - Queen Mary University of LondonOutcomes:
-proportion of women non-persistent with ET within 1, 3, and 5 years, by deprivation/ethnicity and combinations of both;
-probability of non-persistence adjusting for age, stage, comorbidity, other cancer treatments received and type of ET;
-estimates of compliance (mean/by cut-offs) by deprivation/ethnicity;
-proportion of women receiving continuous, versus changing, ET by deprivation/ethnicity;
-time to recurrence and/or cancer death (net survival) by deprivation, ethnicity and adherence;
-excess hazard of recurrence and/or cancer death after adjusting for deprivation, ethnicity and adherence and other confounders;
-total effect of deprivation/ethnicity on differences in recurrence/survival, and which of these are direct or indirect.Description: Lay Summary
Women living in deprived areas, and Black women, have shorter breast cancer survival. One reason for this could be differences in treatment. Five years of endocrine therapy (ET) is recommended for women with oestrogen-receptor positive (ER+ve) breast cancers. ET can prevent breast cancer coming back. Up to half of women regularly miss ET tablets or stop taking ET completely. Missing or stopping ET could be why women from deprived communities and Black women have shorter survival.
This study will investigate if there are differences in adherence to ET. We will examine those who miss (non-compliant) or stop (non-persistent) ET according to deprivation and their ethnicity. We are interested to find out whether differences in the amount of ET taken can explain differences in survival by deprivation and ethnicity.
We will use the Clinical Practice Research Datalink alongside linked NHS datasets to find out who developed cancer, and who died and when. We estimate we will include around 35,000 women who had at least one ET prescription after breast cancer diagnosed 2005 onwards. We will look to see whether women (1) continued, or stopped, taking ET and (2) missed ET tablets (adherence). We will compare adherence across deprivation and ethnic groups. We will examine whether adherence is related to cancer recurrence and survival. We will investigate whether differences in adherence explain differences in survival.
Our project will help understand these breast cancer inequalities, show where action is needed to reduce survival differences and generate ideas for follow-on activities.
Technical SummaryBreast cancer survival is lower in women from deprived areas and, to a lesser extent, Black women. The reasons for these disparities are unclear, but differential treatment utilisation is a possible explanation. Although adjuvant endocrine therapy (ET) reduces risks of recurrence and death in women with oestrogen-receptor positive (ER+ve) breast cancer, up to 50% of women have poor adherence to the medication, regularly skipping doses and/or stopping completely before the recommended treatment period. Because, contemporary, large-scale, studies of patterns of ET adherence in the UK are lacking, we plan to identify if adjuvant ET adherence varies by deprivation and ethnicity and use novel methods to investigate causal pathways linking social characteristics, and adherence and survival.
We will conduct a retrospective cohort study using linked CPRD, HES, NCRD and ONS mortality records. The cohort will be women diagnosed with invasive ER+ve cancer 1/1/2005 onwards who had at least one ET (tamoxifen/aromatase inhibitor) prescription. Start of follow-up time will be defined as NCRD-reported date of diagnosis. Prescription records will be used to create a longitudinal daily history of ET, and two measures of adherence computed: persistence (ET continuation/discontinuation) and compliance (cumulative ET availability).
Multiple regression methods will be used to determine associations between the woman's area-based deprivation, ethnicity and adherence. Patterns of adherence, recurrence and net survival will then be examined and mediation-based survival models used to determine whether adherence mediates relationships between deprivation, ethnicity and survival. Two PPI workshops will identify key unanswered questions and prioritise ideas for follow-on research.
Findings will demonstrate whether there are social inequalities in ET adherence and shed light on the âmechanismsâ by which deprivation and ethnicity may impact survival in breast cancer. By demonstrating whether ET interventions and clinical services need to be specifically tailored towards specific social groups, this research could reduce survival disparities.
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Epidemiology, patients characteristics, management and outcomes of cardiovascular, renal and metabolic disease: a UK retrospective database analysis — He Gao ...
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Epidemiology, patients characteristics, management and outcomes of cardiovascular, renal and metabolic disease: a UK retrospective database analysis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-25
Organisations:
He Gao - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Jil Billy Mamza - Collaborator - AstraZeneca Ltd - UK Headquarters
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK Headquarters
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ysabelle Boo - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
Prevalence; incidence; treatment patterns; adherence; treatment optimisation; treatment discontinuation; inpatient admissions; disease specific admissions; hospital length of stay; outpatient appointments; primary care contacts; inpatient costs; outpatient costs; primary care costs; mortality.
Description: Lay Summary
CArdiovascular, REnal and MEtabolic (CaReMe) diseases include obesity, diabetes heart disease, stroke, kidney disease and liver disease. Collectively, they have a serious impact on a large proportion of the adult population and place a large strain on the National Health Service. Many people have multiple CaReMe conditions because the diseases share similar genetic and lifestyle risk factors and there is an interplay between them. For example, obesity is associated with developing diabetes, which increases the risk of heart disease, stroke and kidney disease. Presence of one condition may also complicate the treatment of another. Medicines used to treat heart failure may adversely affect patients with existing kidney disease. It is therefore important to consider treatment of the patient as a whole rather than an individual disease. However, we still donât know how often people have these multiple conditions, their profile, or how having multiple illnesses impacts health outcomes and treatment costs. In this study we want to use the Clinical Practice Research Datalink to select patients with CaReMe conditions and estimate how many people have each condition individually and in combination. We then wish to assess the characteristics of these patients, how many times they contact health services, the cost of these contacts, the rate of serious medical events including death and how these differ between patient subgroups defined by treatment, demographics and risk factors. This could help inform which patients may benefit from new treatments to improve outcomes and reduce the strain on health services.
Technical SummaryCardiovascular, renal and metabolic (CaReMe) diseases include obesity, type 2 diabetes, cardiovascular disease, kidney disease, liver disease and associated conditions. Affecting a large proportion of the population, these conditions often co-exist with common risk factors, mechanisms and interactions. CaReMe multi-morbidity may exacerbate the risk of adverse outcomes above the sum of the individual conditions, and presence of one condition may contraindicate treatment of another; complicating patient management. We will investigate the epidemiology, treatment and resource utilisation associated with CaReMe conditions using the Clinical Practice Research Datalink (CPRD) Aurum/GOLD databases linked with Hospital Episode Statistics (HES) admitted patient care and outpatient data and Office of National Statistics mortality and Index of Multiple Deprivation data. The primary objective is to describe the incidence and prevalence of these conditions. Secondary objectives are to describe patient characteristics and treatment patterns, assess healthcare resource utilization (HCRU) and describe the risk of adverse clinical outcomes across individual and combined conditions. We will also define âundiagnosedâ conditions based on symptoms and biochemical markers to assess how delay in diagnosis impacts outcomes. Cases will be selected from 2012 to latest available data and trends in incidence and prevalence reported by individual and combined conditions. Incident and prevalent cohorts will be created and baseline demographic, clinical and treatment characteristics described Continuous data will be reported as means, medians and interquartile ranges and categorical data as proportions. Primary and secondary healthcare resource utilisation and costs will be presented for both cohorts. For the incident population, treatment patterns will be described and time to event for mortality, CaReMe specific hospitalisations and events described using Kaplan-Meier curves and predictive variables assessed using a Cox-Proportional Hazards Model. This will allow us to quantify the burden of CaReMe conditions and inform preventative treatments programs, reducing the long-term healthcare resource use associated with the patient.
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Factors affecting development of Preserved Ratio Impaired Spirometry (PRISm); a population-based study — Jennifer Quint ...
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Factors affecting development of Preserved Ratio Impaired Spirometry (PRISm); a population-based study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College London
King Pui Florence Chan - Collaborator - Imperial College London
Rong Ding - Collaborator - Imperial College LondonOutcomes:
Demographic (e.g. age, sex), lifestyle (smoking, body mass index) and clinical factors(e.g. asthma; kidney disease) associated with the development of PRISm
Mortality
Cardiovascular Disease
HospitalisationsDescription: Lay Summary
Lung function tests show how well your lungs work. The tests measure how much air the lungs hold and how forceful one can empty the air from the lungs. These measurements are helpful for doctors to understand if people have or are at risk of certain lung diseases and to help monitor how well treatment is working in people with lung disease. There is a specific group of people who have certain changes in lung function that do not indicate a lung disease but indicate that they may be at risk of lung diseases in the future. This specific condition is called Preserved Ratio Impaired Spirometry (PRISm). PRISm is commonly seen in the general population. The development of PRISm is known to be associated with female sex, older age and is common in people with a lung disease called asthma. Using routine healthcare data, we would like to better understand if there are some other factors that we can measure in routine healthcare data that are associated with PRISm. This will ultimately help us to determine who is at risk of developing lung diseases at an early time, which may allow us to intervene and potentially prevent the development.
Technical SummaryIndividuals can have lung function showing forced expiratory volume (FEV1) and forced vital capacity (FVC) ratio greater than 0.7 but with the FEV1 less than 80% predicted, and this group is recognised as preserved ratio impaired spirometry (PRISm). PRISm group is present in the general population with presentation varying from asymptomatic to having shortness of breath. PRISm is not a distinct type of lung disease, but studies have shown that this group is at risk of increase in cardiopulmonary diseases and mortality. Known risk factors for development of PRISm include female sex, older age and a diagnosis of asthma. However, there is limited knowledge on the development of PRISm and the relationship with other factors. Using linked electronic healthcare record data including CPRD Aurum, HES APC, and IMD and ONS data, we will explore factors associated with developing PRISm. We will use logistic regression and undertake a case-control study (Cases â PRISm, Controls- those without, i.e. normal spirometry). We will also undertake a cohort study to explore mortality in the two groups. This will ultimately help us to determine who is at risk of developing lung diseases at an early time, which may allow us in the future to intervene and potentially prevent the development.
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The Impact of Ethnicity on Surgical Outcomes in Patients with Inflammatory Bowel Disease — David Humes ...
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The Impact of Ethnicity on Surgical Outcomes in Patients with Inflammatory Bowel Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-14
Organisations:
David Humes - Chief Investigator - University of Nottingham
Jennifer Couch - Corresponding Applicant - University of Nottingham
Kathryn Thomas - Collaborator - Nottingham University Hospitals
Timothy Card - Collaborator - University of NottinghamOutcomes:
Primary outcome: Incidence of surgery
Secondary outcomes: route of admission to surgery; 30- and 90-day mortality; return to theatre; readmission; length of stay; restoration of GI continuity; post-operative follow up (colonoscopic surveillance and prescription of maintenance therapy).Description: Lay Summary
In 2023, 16% of people in the UK were of an ethnic minority. Ethnic minorities are not well studied in medical research. Inflammatory bowel disease (IBD) is no exception. Studies have shown the number of people in the UK with IBD is higher than was thought. We also know that IBD in ethnic minorities is increasing.
IBD is a complex disease. People with IBD have a range of symptoms that can come and go. Some symptoms can be managed at home with medicines. Some need major surgery. Studies have shown that ethnic minorities have worse outcomes following surgery. Most of these studies are from North America which has a different population and healthcare system. This study will see if different ethnic groups in the UK have different types of surgery to treat their IBD. It will also see if their outcomes after surgery are worse.
We need to know how access to health care and outcomes following surgery varies between ethnic groups with IBD. This will provide a driving force to make a better service and improve outcomes surgical for all IBD patients.
Technical SummaryThe aim of this study is to assess whether those belonging to ethnic minority groups undergoing surgery for inflammatory bowel disease receive different treatment or experience worse post-operative outcomes. An incident cohort will be defined using medcodes pertaining to IBD in CPRD Aurum or ICD-10 codes from HES with an incident diagnosis between 2003-2023. Ethnic groups will be defined as per CPRD categorisation. The primary outcome is a comparison of IBD surgery between different ethnic groups looking specifically at the type of surgery, route of admission and use of minimally invasive surgery. Surgery will be defined using OPCS-4 codes in HES along route of admission. Secondary outcomes will
compare post-operative outcomes between ethnic groups. We will use the following outcome measures; post-operative mortality, readmission, return to theatre, length of stay, time to restoration of GI continuity and whether patients received sufficient follow up following. Length of stay, readmission and return to theatre as well as stoma formation and restoration of GI continuity will be acquired from the HES data and date of death from ONS mortality data. Endoscopy follow up data will the defined using OPCS-4 codes in HES and the use of maintenance therapy from prescription data in HES.Data management and statistical analysis will be performed using Stata SE version 18. Kaplan-Meier methods will be used to report the cumulative incidence of surgery from date of diagnosis. Cox multivariate regression models will be used to examine the risk of surgery between ethnic groups and covariates. Cox regression will be used assess the 90-day mortality, readmission and return the theatre.
In the context of changing demographics of the UK population this study may help guide the planning and development of IBD services in order the address any inequities that exist between ethnic groups.
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Explainable machine learning models to assess risk of familial hypercholesterolaemia: A cohort study — Ralph Kwame Akyea ...
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Explainable machine learning models to assess risk of familial hypercholesterolaemia: A cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-13
Organisations:
Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Nadeem Qureshi - Collaborator - University of NottinghamOutcomes:
Incident diagnosis of familial hypercholesterolaemia
- Develop and internally validate a familial hypercholesterolaemia prediction algorithm
Description: Lay Summary
Familial Hypercholesterolaemia is a common inherited condition that causes high cholesterol levels from birth, affecting around 320,000 people in the UK. "Familial" means it runs in families and "hypercholesterolaemia" means high blood cholesterol. Despite its prevalence, over 80% of individuals with familial hyercholesterolaemia remain undiagnosed and untreated, leading to an estimated 140,000 avoidable heart attacks and premature deaths in the UK alone. Timely diagnosis and use of cholesterol-lowering medication can significantly reduce the risk of developing heart disease and other serious health problems.
Routinely collected electronic health records offer a unique opportunity to improve the timely diagnosis by accurately calculating the risk of familial hypercholesterolaemia in the general population at scale. This study aims to use routinely collected patient records from general practices across England to develop a tool to help predict familial hypercholesterolaemia.
The findings from this study will support the development of a new computer-based tool that could be added directly into electronic health record systems for general practices. This tool would help healthcare providers in assessing risk levels for familial hypercholestwerolaemia. This will enable timely diagnosis, targeted treatment, and efficient resource allocation. Ultimately, this will improve patient outcomes and reduce healthcare costs associated with undiagnosed and untreated familial hypercholesterolaemia.
Technical SummaryBackground: Familial hypercholesterolaemia (FH) is the most common inherited condition leading to raised cholesterol levels, affecting over 1 in 250 individuals. Without timely diagnosis and effective management, FH significantly increases the risk of premature heart disease and death. In the UK, approximately 320,000 people are estimated to have FH, however, most (80%) remain undiagnosed. This represents a missed opportunity for preventing premature heart disease and death.
Aim: To develop and internally validate explainable machine learning model(s) to assess familial hypercholesterolaemia risk.
Study Design: Open cohort
Setting: English General Practices
Participants: Patients aged 16 years and older between 1st January 2005 and 31st December 2023 with primary care records (CPRD Aurum) linked to hospitalisation records (HES Admitted Patient Care).
Primary outcome: Incident diagnosis of familial hypercholesterolaemia
Methods: Using CPRD Aurum, explainable machine learning algorithms will be used to develop and internally validate familial hypercholesterolaemia risk prediction models. The performance of the model(s) will be assessed in terms of discrimination (predictive accuracy) using Harrellâs C-statistic, positive predictive value (PPV: percentage of patients with dementia correctly identified) and the model calibration using calibration slope by plotting agreement between predicted and observed events.
Outputs: Explainable familial hypercholesterolaemia risk prediction model(s) using linked GP and hospitalisation data could inform the population-level strategies currently used to improve the identification of patients with familial hypercholesterolaemia within the UK general population.
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The patterning of mental and physical multimorbidity across the life course and mediators for progression towards burdensome functional outcomes — Alex Dregan ...
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The patterning of mental and physical multimorbidity across the life course and mediators for progression towards burdensome functional outcomes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-03
Organisations:
Alex Dregan - Chief Investigator - King's College London (KCL)
Alex Dregan - Corresponding Applicant - King's College London (KCL)
David Armstrong - Collaborator - King's College London (KCL)
Jayati Das-Munshi - Collaborator - King's College London (KCL)
Niamh Doherty - Collaborator - King's College London (KCL)
Simon Fraser - Collaborator - King's College London (KCL)Outcomes:
The study primary outcome will be mental and physical multimorbidity, defined as the concurrent existence of two or more physical or mental disorders. Several secondary outcomes will be investigated, including functional impairment (physical disability, psychological symptoms, and cognitive decline), frailty, employment and social relationships, financial status (e.g., low income, financial problems, receiving employment-related benefits), quality of life (QoL), safety outcomes (e.g., falls, fractures, self-harm, adverse drug-effects, elevation in liver or kidney functioning tests), polypharmacy (three or more prescriptions from different drug classes), healthcare utilisation (e.g., referrals, hospital admission, consultations), and all-cause mortality.
Description: Lay Summary
A growing number of people live with more than one long-term (âchronicâ) health condition and their associated consequences, such as poor mobility, low quality of life, and increased use of health services. People who live with more than one chronic condition tend to visit their practice and are admitted to hospitals more often than people with no long-term conditions. We know that certain combination of long-term conditions occur together more often than
others. However, we know little about which group of conditions have the worse effects on people future health or those associated with the greatest use of care services. This project will assess the number of people that live currently with more than one conditions and will tell us which combination of long-term conditions have the worse impact on patients health and well-being and those associated with greater use of the healthcare services.
There is also limited knowledge about how best to reduce the chances of people developing multiple long-term conditions or delay the onset of decline in health status. We do not know, for instance, whether improving lifestyle behaviours, such as diet or physical activity, will reduce the chance of people experiencing a decline in their mobility or memory.Our findings will support public health specialists and policymakers by (a) optimal allocation of health service funds to prevent the development of multiple long-term conditions and (b) informing future health interventions to improve people mental, cognitive and physical health.
Technical SummaryAims: Mental and physical multimorbidity is projected to triple over the next 15 years, affecting almost 2million young people and adults. Patients with mental disorders (M/CD) (e.g. depression, anxiety, or schizophrenia) are disproportionately at higher risk of multimorbidity, defined as two or more coexisting conditions. The proposed study aims to establish the epidemiology of mental and physical multimorbidity, its underlying mechanisms, and the impact of current therapeutic and care pathways on disease progression and prognosis. Whenever feasible, these aims will be explored separately by age, sex, ethnicity, and deprivation.
Primary exposures: Diagnoses of mental and physical co-occurring conditions. We will also document personal and service-level interventions that may mediate the progression from multimorbidity clusters to functional decline and healthcare utilisation.
Outcomes: Primary study outcome will be incidence of mental and physical multimorbidity over the study period. In addition, the study will estimate indicators of burdensome multimorbidity, such as frailty, functional impairment, quality of life, healthcare utilisation, and all-cause mortality.
Study design: Prospective matched cohort study.
Methods: Multivariable longitudinal analyses will be implemented using several statistical techniques, including latent class analysis, Cox regression, linear mixed effects models, and conditional logistic regression. Machine learning algorithms will be used to identify clusters of symptoms, indicative of care burden and to map temporal trajectories of multimorbidity and functional decline.
Linked datasets: Index of Multiple Deprivation (patient level), HES Admitted Patient Care (APC) and HES Outpatient data.
Findings: The proposed study will provide novel understanding about processes responsible for the emergence and poor prognosis of mental and physical multimorbidity at different life stages and will allow direct comparison of these processes and outcomes across women, ethnic minorities, and those socially deprived. Such information will inform the development of preventive strategies that are relevant for specific populations at greater need of support.
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Trends in the use of commonly used antibiotics associated with antimicrobial resistance — Daniel Dedman ...
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Trends in the use of commonly used antibiotics associated with antimicrobial resistance
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-11
Organisations:
Daniel Dedman - Chief Investigator - CPRD
Zara Cuccu - Corresponding Applicant - CPRD
Bipin Steephen - Collaborator - CPRD
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Rhys Barnett - Collaborator - CPRD
Yuchen Guo - Collaborator - University of OxfordOutcomes:
Database characterisation; domain and concept set frequencies. Quarterly prescribing incidence rates of antibiotics on the WHO watch list; new users of antibiotics, and antibiotic treatment episodes.
Description: Lay Summary
Antibiotics are essential in the treatment of infections caused by bacteria. A major concern is that if used too frequently or inappropriately, some bacteria can become resistant to the antibiotics. To encourage appropriate use, antibiotic stewardship programs have been launched to monitor antibiotics use and ensure treatment guidelines are followed.
The objective of this study is to estimate trends in the number of new users of common antibiotics potentially associated with antimicrobial resistance as listed for close surveillance by the World Health Organisation. In addition, we will describe the characteristics of those taking these antibiotics and summarise the antibiotic use in terms of duration, route, and dose.
Technical SummaryWhile antibiotics are crucial in the treatment of infections caused by bacteria, one of the major concerns is the risk of resistance through their inappropriate use. To improve the appropriate use of antibiotics, antimicrobial stewardship programs have been set up with the aim to monitor antibiotics use and ensure that guidelines are strictly adhered to.
CPRD Aurum will be used for a cohort study of all people in the database from 2012 to the end of data capture. The drugs of interest are antibiotics from the WHO watch list. Exposure to antibiotics will be based on prescription and/or dispensation data. Demographic information such as age and sex, other medicine use, and diagnoses of comorbidities and possible indications will be identified to characterise the antibiotics users. The HES Admitted Patient Care data will be used for characterisation of comorbidities and possible indications.
The main statistical analyses include; 1) Characterisation of the database, including a description of the characteristics of patients at entry in the database, summaries of trends in records across different domains over time, geographical coverage of the database, and analysis of missing data in required fields. 2) Estimation of incidence rates of prescribing of antibiotics on the WHO watch list. 3) Characterisation of users of antibiotics, including diagnoses of relevant comorbidities and indications for treatment. 4) Characterisation of antibiotic drug treatment episodes, including summary of duration of use and initial dose.
This study will improve our understanding of the use of common antibiotics in the Watch category in the United Kingdom (UK) and will benefit public health by ensuring that guidelines on the use of antibiotics are strictly adhered to.
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Inflammation, nutrition, and the evolution of multiple long term conditions. Using advanced computer programmes to explore how multiple factors impact on people's health using longitudinal data. — Alexander MacGregor ...
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Inflammation, nutrition, and the evolution of multiple long term conditions. Using advanced computer programmes to explore how multiple factors impact on people's health using longitudinal data.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-04
Organisations:
Alexander MacGregor - Chief Investigator - University of East Anglia
Charlotte Davies - Corresponding Applicant - University of East Anglia
Ailsa Welch - Collaborator - University of East Anglia
Alex Lewin - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Chris Fox - Collaborator - University of East Anglia
Daniel Asfaw - Collaborator - University of East Anglia
Elena Kulinskaya - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Min Aung - Collaborator - University of East Anglia
Soumya Subhra Paria - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tahmina Zebin - Collaborator - Brunel University LondonOutcomes:
Primary Outcomes
⢠Incident long term conditions, defined by the first recorded diagnosis in primary and secondary care records. A list of chronic conditions has been derived by literature review with the relevant Read/SNOMED codes.
⢠MLTC is defined as ⥠2 chronic conditions.
⢠These will be used to develop trajectories of MLTC incidence and progression.
⢠A full code list is provided in the Appendix.
Secondary outcome measures
Health service utilisation:
⢠Emergency department attendances
⢠Number of hospital admissions
⢠Outpatient secondary care attendance
⢠In patient Length of stay
⢠Primary care appointments by clinician typeDescription: Lay Summary
'Multimorbidity' refers to having two or more long-term conditions (MLTC) in one person, such as high blood pressure and joint pain. In the United Kingdom (UK), one in four people have MLTCs, posing a significant challenge for individuals and health services. While it is well known that certain conditions often occur together, the reasons for why this is happening are not yet fully understood. This knowledge is crucial for determining effective interventions to limit MLTC progression.
Technical Summary
Our group has received funding from the National Institute for Health and Care Research (NIHR) to use advanced statistical and computing tools (Artificial Intelligence, AI) to analyse large national and international datasets, to understand how MLTC develops over a lifetime. Our focus is on chronic inflammation, the body's response to threats like infections, underlying many diseases.
We will examine the Clinical Practice Research Datalink (CPRD), including General Practice (GP) and hospital records of around 18 million patients aged 40 and over in England, to estimate how common MLTC is and determine which conditions cluster together. Using data from blood test results, we will explore how inflammation drives disease progression over a lifetime. Additionally, we will consider how people's cultural background (including race) and position in society (such as income and education) combine with inflammation to influence the likelihood of developing MLTCs.
The goal is to develop tools for primary care to predict MLTC, enabling timely and effective prevention by GPs and health professionals particularly to support communities most at risk of developing MLTC.Aim and Objectives
The overarching aim of this research is to improve the understanding of multiple long term condition (MLTC) development and its associated healthcare burden, with a specific focus on the role of chronic inflammation. The specific objectives are to:
- Estimate the prevalence of MLTC and identify longitudinal clustering patterns throughout the lifecourse.
- Quantify the individual-level variation in MLTC risk by age, sex, ethnicity, and socio-economic background.
- Explore the role of chronic inflammation in the development of MLTC using established biomarkers.
- Estimate primary and secondary healthcare utilisation among individuals with two or more MLTC.Study Population
The study population will include all individuals aged 18 years and over within the Clinical Practice Research Datalink (CPRD) Aurum database, covering the period from April 1997 to September 2024.Data Sources
Electronic health record data from CPRD Aurum. This data will be linked with secondary healthcare records, socio-demographic datasets, and laboratory test results to achieve the research objectives.Study Design
Retrospective cohort design. The analytical approach will apply advanced statistical and artificial intelligence (AI) methods to analyse complex multimorbidity patterns over time. The methods will induce: Machine Learning Techniques (Transformer models and language-based models for pattern recognition); multistate models and neural ordinary differential equations (ODEs) to capture disease progression. We will include equity considerations to assess how factors such as age, sex, ethnicity, socio-economic status, and health inequalities contribute to the development of MLTC.This research forms part of a wider NIHR funded programme grant (InflAIM) that is investigating the role of inflammation and nutrition in the development of multiple long term conditions.
The findings will provide a foundation for developing targeted, evidence-based interventions to be implemented in primary care settings, aiming to prevent or delay the onset of MLTCs in at-risk populations.
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Inequalities in disadvantaged populations experiencing co-occurring mental health and substance use disorders — Sheena Ramsay ...
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Inequalities in disadvantaged populations experiencing co-occurring mental health and substance use disorders
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Sheena Ramsay - Chief Investigator - Newcastle University
Kate Timmins - Corresponding Applicant - Newcastle University
David Sinclair - Collaborator - Newcastle University
Emma Adams - Collaborator - Newcastle UniversityOutcomes:
Primary: Co-occurring diagnoses of mental and substance use disorders (see criteria below).
Secondary: Data-driven clusters (latent classes) of co-occurring diagnoses of mental health and substance use disorders.
Secondary: Referral to secondary substance use or mental health services.Description: Lay Summary
Social and economic deprivation is one way in which people may face disadvantages in health status and outcomes. We know that mental health problems affect certain populations much more than others, such as those in socioeconomically deprived areas, and certain ethnic groups. This is also true of problems with substance use (drugs or alcohol). Both result in inequalities in health.
Technical Summary
People who have mental health problems often also have problems around using substances or vice versa. This co-occurrence of both problems means that people have additional challenges with finding the right treatment. Despite this, we donât know if or how different population groups are differently affected by these co-occurring problems, for example, those in more deprived areas or some ethnic groups. We also do not know how people with severe forms of deprivation, such as homelessness, may also be affected by these co-occurring problems. These population groups could be much more impacted by health inequalities.
Using a large selection of anonymised records from general practices we aim to describe how many people (the âprevalenceâ) have diagnoses of these co-occurring problems and see how the prevalence varies between population groups (such as different deprivation groups, ethnic groups, age groups, or by gender). We will also investigate if different types of mental health and substance use problems â for example, depression, schizophrenia, marijuana use, harmful alcohol drinking - tend to occur together. We will use this analysis to see where interventions or policies might be more focussed to reduce health inequalities.We aim to improve our understanding of the potential socioeconomic inequalities in the burden of co-occurring diagnoses of mental and substance use disorders among adults. We will do so through a descriptive study design, using large-scale data on diagnoses from electronic primary care health records.
Firstly, using a cohort study design, we will calculate incidence and prevalence rates of having at least one diagnosis of a mental disorder as well as at least one diagnosis of a substance use disorder among adults registered with a CPRD practice between 1st January 2010 and 31st December 2023. We will stratify by key socioeconomic variables (ethnicity, deprivation, rural-urban classification, homelessness/housed) to contrast rates between population groups and describe possible inequalities. For this, we will link with small output area-level data. We will explore calculating an index of inequality to capture the cumulative impacts of these socioeconomic factors and better describe patterns and trends, if data allow.
Next, in a cross-sectional study we will use data-driven approaches (cluster analysis) to describe in more detail how diagnoses of mental and substance use disorders co-occur. Again, stratifying analyses by sociodemographic variables will enable us to describe if and how these clusters vary across groups.
A secondary objective will be to compare rates of access to healthcare services (in the form of referrals to secondary care services) within a cohort study design with this sample, estimating prevalence rate ratios by latent class membership, by ethnicity and by index of multiple deprivation (IMD), where data allow.
The anticipated public benefit of these investigations will be in how the information could be used by policy makers to create targeted and/or tailored interventions to reduce health inequities.
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Patient Characteristics, Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization of Patients who Restarted Treatment with Cannabidiol (Epidyolex) in UK population — Artak Khachatryan ...
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Patient Characteristics, Treatment Patterns, Clinical Outcomes and Healthcare Resource Utilization of Patients who Restarted Treatment with Cannabidiol (Epidyolex) in UK population
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-14
Organisations:
Artak Khachatryan - Chief Investigator - LA-SER Europe Ltd ( UK )
Kazue Kikuchi - Corresponding Applicant - LA-SER Europe Ltd ( UK )
gaelle gusto - Collaborator - LA-SER Europe Ltd ( UK )
Giancarlo Pesce - Collaborator - LA-SER Europe Ltd ( UK )
Heng Jiang - Collaborator - LA-SER Europe Ltd ( UK )
Nadia Quignot - Collaborator - LA-SER Europe Ltd ( UK )
Nina Shigesi - Collaborator - LA-SER Europe Ltd ( UK )
Raissa Kapso Kapnang - Collaborator - LA-SER Europe Ltd ( UK )Outcomes:
Baseline characteristics: age at cannabidiol restart sex, diagnosis of Dravet syndrome Lennox-Gastaut syndrome, tuberous sclerosis complex, other epilepsy conditions, epilepsy specific comorbidities, Charlson comorbidity and paediatric comorbidity index components.
Treatment patterns: time to restart, comedications, duration of the restarted treatment.
Clinical outcomes neurological development disorders such as autism and ADHD; occurrence of adverse events such as status epilepticus, diarrhoea, abnormal weight change, suicidality, aggression and mortality.Description: Lay Summary
Patients with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex typically experience frequent and severe seizures from an early age, which makes them more likely to have accidents or even death. These seizures can greatly affect their daily life as well as their physical and mental development. However, most anti-seizure medications do not always work well and often have side effects. As a results, patients may need to stop one medication and try another, but because there are only a limited number of anti-seizure medications available, they might have to stop and restart some treatments. Cannabidiol, a new treatment option, has shown promise for these patients. However, no study has looked into how restarting cannabidiol affects patients or why they choose to restart it. Therefore, this project will investigate the patient characteristics, treatments, clinical outcomes and healthcare use of patients who restarted cannabidiol in a real-world setting to help provide valuable reference for clinical guidance.
Technical SummaryEpidyolex® (cannabidiol) received a marketing authorization in the UK for Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), tuberous sclerosis complex (TSC)-associated seizures, which provides an important additional treatment option for patients affected by these challenging conditions. Due to the potential changes in disease presentation in epilepsy and the side effects associated with anti-seizure medications, a patient might discontinue one anti-seizure medication and switch to another. There is a limited understanding of the reasons for discontinuing and restarting cannabidiol, and real-world study on the patient characteristics, their clinical management and treatment patterns, clinical outcomes, and healthcare resource utilization and costs are lacking. This project aims to provide real-world insights on patients who restarted treatment with cannabidiol. The data generated can inform and optimize clinical management strategies, ultimately improving patientsâ outcomes and enhancing clinical guidelines, as well as aid policymakers to make informed decisions regarding healthcare resource allocation and fundings for treating these rare diseases. The study team commits to full transparency during the conduct of the study, with results published in scientific journals, ensuring that the knowledge gained is accessible to the wider medical and scientific community, fostering a collaborative approach to improving patient care.
This study will be a non-interventional, retrospective cohort study. The exposure is the restart of cannabidiol treatment after discontinuation. The key study outcomes include patient characteristics, treatment patterns, epilepsy related clinical outcomes, and healthcare resource utilization.
The approach to the statistical analysis will be descriptive, so no formal hypotheses will be tested. Categorical variables will be summarized by number of observations and percentages. Continuous variables will be described with number of patients, mean, standard deviation; minimum, maximum, median, first and third quantiles). Subgroup analyses will be conducted by age, sex, diagnosis of epilepsy or non-epilepsy conditions if there are ⥠5 patients in each subgroup.
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Recent trends in the incidence and prevalence of interstitial lung diseases in England, 2005-2022 — Jennifer Quint ...
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Recent trends in the incidence and prevalence of interstitial lung diseases in England, 2005-2022
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Peter George - Collaborator - Royal Brompton HospitalOutcomes:
Annual incidence (per 100,000 person-years) and prevalence (per 100,000 persons) of all ILD and major ILD subtypes, 2005â2022:
⢠idiopathic interstitial pneumonias (including IPF);
⢠exposure-related ILDs (including hypersensitivity pneumonitis);
⢠SARD-related ILDs
⢠pulmonary sarcoidosis;
⢠other (including drug- and radiation induced, cystic lung disease).Crude and age- and sex-standardised (all-cause) mortality rates in all ILD and major ILD subtypes.
Major ILD subtypes as a proportion of all ILD (2005â2009 vs 2018â2022).
Description: Lay Summary
The term âinterstitial lung diseaseâ or ILD is used to describe a large group of rare lung diseases which cause inflammation and scarring in the lungs. Between 200â300 individually-named diseases fall under this umbrella, the most common, and most serious, of which is idiopathic pulmonary fibrosis (IPF). People with IPF tend to die within 3â5 years of diagnosis because of progressive buildup of scar tissue in their lungs which stops them from being able to breathe properly.
Technical Summary
The other, less common ILDs are very varied in terms of their causes and features. In some, like IPF, the scarring or âfibrosisâ is the dominant feature; in others itâs inflammation, and sometimes both inflammation and fibrosis are present. The sheer number and diversity of conditions that come under the ILD umbrella makes this a difficult disease group to study and we donât even know for sure how many people in the UK have an ILD. This is especially true of the rarer non-IPF types of ILD, for example, one called hypersensitivity pneumonitis. This condition is linked to exposure to airborne dust particles, often in the workplace. The aim of this research is to better understand how many people have ILD, what type of ILD they have, and whether the number of people diagnosed with ILD has changed over the past 15 years. This information is needed to help ensure that health services match the care needs for patients with all types of ILD.The objective of this study is to describe trends in the interstitial lung disease (ILD) burden in England over the period, 2005â2022. This period spans a time when interest in ILDs has increased, in particular, in idiopathic pulmonary fibrosis (IPF), the most common and most serious of the conditions under the ILD umbrella. This interest has been driven by the introduction of anti-fibrotic therapies which have been shown to slow the rate of loss of lung function, not only in people with IPF but also in people with other subtypes of ILD whose disease is likewise characterised by a progressive lung fibrosis.
For a variety of reasons, the epidemiology of ILD in England remains poorly characterised. This is especially true of the non-IPF ILDs for which population-level estimates of incidence and prevalence are either lacking or at best highly variable and uncertain. In this study, we will draw on previous work in IPF to derive various algorithms for defining cohorts of people with an ILD diagnosis in linked Aurum data. We will use these case-finding algorithms to calculate incidence (per 100,000 person-years) and prevalence (per 100,000 persons) of all ILD and of each of the following major subtypes:
⢠idiopathic interstitial pneumonias;
⢠exposure-related ILDs;
⢠systemic auto-immune rheumatoid disease (SARD)-related ILDs
⢠pulmonary sarcoidosis;
⢠other (including drug- and radiation-induced, cystic lung disease).Incidence and prevalence will be estimated for each year of our study period, stratified by sex and IMD; annual average trends will be quantified using negative binomial or binomial regression models. In addition, we will compute crude and age- and sex-standardised (all-cause) mortality rates in people with ILD, overall and separately for the major ILD subtypes; we will also report the major ILD subtypes as a proportion of all ILD, comparing 2005â2009 with 2018â2022.
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Understanding mental health distress and suicide among autistic individuals — Elizabeth Weir ...
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Understanding mental health distress and suicide among autistic individuals
Datasets:GP data, Primary Outcomes: psychiatric hospitalization; psychiatric A& E visit; suicidal ideation; suicide-related referral/risk assessment; self-harm/suicide attempt; suicide; unexpected death; severe psychiatric distress (any of the above). Secondary Outcomes: depression; anxiety; OCD; ADHD; dyslexia; dyspraxia; PTSD; schizophrenia; perinatal mental health; substance misuse/addiction; bipolar; eating disorders; personality disorders; and timing of autism diagnosis; psychiatric appointments and hospitalizations (total and by type); which service receives psychiatric concern/severe distress; presence and type of psychiatric support prior to/after severe psychiatric distress; duration between any events (psychiatric hospitalization, diagnosis, distress, referral, or support); number of psychiatric-related events (all listed above) prior to suicide or unexpected death.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-20
Organisations:
Elizabeth Weir - Chief Investigator - University of Cambridge
Elizabeth Weir - Corresponding Applicant - University of Cambridge
Carrie Allison - Collaborator - University of Cambridge
Fiona Matthews - Collaborator - University Of Hull
Holly Hodges - Collaborator - University of Cambridge
Jacqui Rodgers - Collaborator - Newcastle University
Mirabel Pelton - Collaborator - University of Cambridge
Rachel Moseley - Collaborator - University Of Bournemouth
Sarah Cassidy - Collaborator - University of Nottingham
Simon Baron-Cohen - Collaborator - University of Cambridge
Tamsin Ford - Collaborator - University of Cambridge
Tanatswa Amanda Chikaura - Collaborator - University of Cambridge
Tanya Procyshyn - Collaborator - University of CambridgeOutcomes:
Primary Outcomes: psychiatric hospitalization; psychiatric A&E visit; suicidal ideation; suicide-related referral/risk assessment; self-harm/suicide attempt; suicide; unexpected death; severe psychiatric distress (any of the above).
Secondary Outcomes: depression; anxiety; OCD; ADHD; dyslexia; dyspraxia; PTSD; schizophrenia; perinatal mental health; substance misuse/addiction; bipolar; eating disorders; personality disorders; and timing of autism diagnosis; psychiatric appointments and hospitalizations (total and by type); which service receives psychiatric concern/severe distress; presence and type of psychiatric support prior to/after severe psychiatric distress; duration between any events (psychiatric hospitalization, diagnosis, distress, referral, or support); number of psychiatric-related events (all listed above) prior to suicide or unexpected death.
Description: Lay Summary
This project aims to understand the needs of autistic people in relation to their mental health, including severe mental health distress and suicide. Data from other countries suggests that as many as 1 in 4 autistic adults may attempt suicide. This number is unacceptably high; however, the NHS and UK government currently lack UK specific statistics on suicide and mental health among autistic people. This project considers how factors are associated with mental health concerns among autistic people, including personal characteristics (such as ethnicity and education), co-occurring health conditions, and healthcare use. It assesses how autistic people access mental health support and how long it takes them to receive support. The project also explores what support was provided by the NHS prior to and after an instance of severe distress (such as a mental health-related A&E visit); the study investigates related factors, such as how this support changed during and after the Covid-19 pandemic. This project will provide the first nationally representative statistics on mental health conditions and suicide among autistic people in the UK. Many of these factors have never been explored in large-scale studies anywhere in the world. In the UK, this project will provide statistics that can help to guide the government and NHS on how to develop supportive mental health services that are tailored to the needs of autistic people, including developing autism-specific support for suicide prevention. Globally, these statistics can help to inform international public health policy for supporting the mental health of autistic people.
Technical SummaryThis project employs clinical and referral records from CPRD Gold and Aurum, as well as linkages to Outpatient, Admitted Patient Care, and Accident and Emergency Hospital Episode Statistics (HES); ONS death records; and Patient-Level Indices of Multiple Deprivation, Ethnicity Linkage, and Rural-Urban Indices to characterize the psychiatric conditions, healthcare utilization, and severe psychiatric distress/suicide of autistic people. It assesses how these factors differ based on age, gender, ethnicity, socioeconomic status, rurality/regional differences, timing of autism diagnosis, and intellectual ability status compared to non-autistic people. It considers how healthcare utilization and risks of co-occurring health conditions relate to mental health. The project characterizes the support provided by the NHS before and after instances of severe psychiatric distress, including information on timing, duration, type of support offered, and whether support differed during the Covid-19 pandemic. The project leverages summary statistics (e.g., Chi-Square, Mann-Whitney U tests), as well as unadjusted and adjusted regression models (including logistic regression and Cox regression, using age as the time variable), comparing (1) autistic people to (2) non-autistic people in most studies, as well as (1) autistic people with a psychiatric condition and/or severe psychiatric distress to (2) non-autistic people with a psychiatric condition and/or severe psychiatric distress, (3) autistic people with neither, and (4) non-autistic people with neither in others. Autistic people are defined by a relevant autism code (Appendix 1) between 1st January 1995 and 31st December 2024; severe psychiatric distress and psychiatric conditions are defined by a relevant code at any time (Appendices 2 and 3, respectively). Individuals with missing data for key demographics are excluded and Multiple Imputation for Chained Equations (MICE) used for other variables. Statistical significance is adjusted by applying Benjamini-Hochberg False Discovery Rate correction, as appropriate.
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Temporal trends of cardiometabolic risk factors and their impact on cardiometabolic disease outcomes — Barbara Iyen ...
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Temporal trends of cardiometabolic risk factors and their impact on cardiometabolic disease outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-19
Organisations:
Barbara Iyen - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Riyaz Patel - Collaborator - Barts Health and UCLH NHS Trusts
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
⢠Temporal trends of cardiometabolic risk factors.
⢠Incidence of cardiometabolic disease.
⢠Cardiovascular mortality and all-cause mortalityDescription: Lay Summary
Cardiometabolic diseases refers to a group of conditions that affect the heart and blood vessels as well as the bodyâs ability to control blood sugar and produce energy. This includes conditions such as heart disease, stroke, diabetes, and the build-up of fat in the liver. In individuals with cardiometabolic diseases, important risk factors such as being overweight or obese, having high cholesterol, high blood pressure, and inability of insulin to control blood sugar levels, can often occur together. Over time, these risk factors can increase the risk of both ill health and death (âserious health outcomes"). It is unclear to what extent these risk factors or health conditions may co-exist before leading to a serious health outcome, and if having more than two of these risk factors further increases the chances of developing cardiometabolic disease or increases the likelihood of death.
To help answer this research question, we propose to study general practice electronic health records of adults aged 25 years or over, who have no cardiometabolic diseases or risk factors. We will monitor how the cardiometabolic risk factors develop over time and any related health problems that occur. The findings will help us understand the order in which these risk factors develop, combine, and link to different cardiometabolic disease outcomes. This research will also help recognise individuals who are at higher risk and support ways to develop targeted interventions to delay or prevent the onset of these diseases.
Technical SummaryBackground:
Various risk factors including hypertension, dyslipidaemia, impaired glucose tolerance, smoking, obesity, and ethnicity, increase the likelihood of developing cardiometabolic disease(1). There is limited evidence on the temporal sequence of cardiometabolic risk factors and how they relate to subsequent cardiometabolic disease outcomes in adults without pre-existing cardiovascular or cardiometabolic conditions.Aim: To determine the temporal trends of cardiometabolic risk factors, and associated risk of cardiometabolic disease and mortality outcomes.
Design: Cohort study
Setting: UK General Practices providing data to CPRD Aurum, with linkage to hospitalisation [Hospital Episode Statistics (HES)], social-economic (deprivation), and Office for National Statistics (ONS) mortality records.
Study population: Adults aged 25 years and over between 1-Jan-2005 and 31-Dec-2023, without a record of cardiovascular disease (ischaemic heart disease, stroke, transient ischaemic attack, peripheral vascular disease, heart failure, atrial fibrillation), diabetes, pre-diabetes, pre-hypertension, chronic renal failure and non-alcoholic fatty liver disease (NAFLD).
Exposures:
The primary exposures will be pre-disease states, defined as pre-diabetes (non-diabetic hyperglycaemia, impaired glucose tolerance or impaired fasting glucose), and pre-hypertension (elevated/high-normal blood pressure). Other exposure variables of interest will include dyslipidaemia, and elevated body mass index (obesity/overweight)Outcome: The occurrence of cardiometabolic risk factors or disease (including hypertension, type-2-diabetes, cardiovascular disease (coronary heart disease, stroke, peripheral vascular disease), and NAFLD.
Covariates: Patient demographics (age, sex, ethnicity, socioeconomic deprivation), lifestyle (smoking, alcohol consumption), comorbidities, and medication that alter the risk of cardiometabolic disease
Methods:
Multistate models using the non-parametric Aalen-Johansen estimator (or Markov proportional hazards) to model the temporal sequence of cardiometabolic risk factors. Cox regression models will examine transition-specific hazards for cardiometabolic disease outcomes, adjusting for covariates. Subgroup analyses stratified by categories of BMI, socioeconomic status, and ethnicity.Outputs: Evidence on the progression of cardiometabolic risk factors and their transition to chronic diseases, helping to identify high-risk populations and inform early public health intervention strategies.
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Optimising transient ischaemic attack (TIA) pathways to reduce ethnicity-based inequalities — Elizabeth Teale ...
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Optimising transient ischaemic attack (TIA) pathways to reduce ethnicity-based inequalities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-26
Organisations:
Elizabeth Teale - Chief Investigator - University of Leeds
Kate Best - Corresponding Applicant - University of Leeds
Andrew Clegg - Collaborator - University of Leeds
Bin Chi - Collaborator - University of Leeds
Tom Crocker - Collaborator - University of LeedsOutcomes:
SERVICE-LEVEL OUTCOMES (Analysis 1)
⢠Attendance at a TIA clinic within 3 months of suspected/ confirmed TIA
⢠Referral to a TIA clinic within 3 months of suspected/ confirmed TIACLINICAL OUTCOMES
⢠Stroke within one year of confirmed TIA (Analysis 2)
⢠Stroke within one year of a suspected TIA (Analysis 3)(See Exposures, Outcomes and Covariates section for detail on outcome definitions)
Description: Lay Summary
Stroke can be devastating for individuals and their families. People from ethnic minority groups are up to twice as likely to have a stroke as white British people, and these happen at younger ages. Before a stroke, up to 1 in 5 people will have a warning 'mini stroke' called a Transient Ischaemic Attack (TIA); this can feel and look the same as a stroke, but symptoms resolve within 24 hours. Getting medical help after TIA is urgent even if symptoms have gone because the risk of stroke is greatest soon after a TIA. This risk can be greatly reduced for people who are seen and treated by specialists quickly after their TIA.
Effective treatment for TIA relies on steps in the âTIA pathwayâ: seeking help; being referred to and attending clinic; accepting treatment and sticking to it. We will use electronic health record data from 11 million patients (which cannot be linked back to individuals) to investigate if personal characteristics (ethnic group, age, sex, deprivation score) are related to a) TIA clinic referral or attendance after suspected TIA, and b) the likelihood of having a stroke in the year after TIA clinic attendance.
Working with patients and members of the public from diverse ethnic groups, and people who design and deliver health services we will suggest improvements for the delivery of TIA pathways to make it easier for people from ethnic minority groups to get appropriate TIA care.
Technical SummaryUp to 1 in 5 strokes are preceded by a Transient Ischaemic Attack (TIA). Rapid assessment and management of TIA in specialist clinics can reduce occurrence of subsequent stroke by 80%. It is unknown whether TIA pathways are equally accessible to all. Intersectional inequalities may exist for people who experience multiple interlocking systems of disadvantage (relating to e.g. ethnicity, age, sex, deprivation). We aim to investigate quantitatively whether membership of some intersectional strata (groupings we will form based on permutations of ethnicity, age, sex and deprivation subgroups) confers particular risk of inequalities in TIA clinic access, attendance and stroke outcome following a TIA.
Among those with suspected TIA, we aim to explore referral and attendance rates at TIA clinics according to intersectional strata. We will use data from CPRD Aurum and HES outpatient data to derive a retrospective cohort of patients with a suspected TIA between 2021-2024. We will ascertain which patients received a referral to a TIA clinic within 3 months of suspected TIA using CPRD Aurum, and we will derive which patients attended a TIA clinic using CPRD Aurum and HES Outpatient data. Among those with confirmed TIA, determined using CPRD Aurum and HES Outpatient data, we will also examine whether the stroke incidence (within one year) varies by intersectionality. Strokes will be ascertained using data from CPRD Aurum, HES A&E and HES Admitted Patient Care. We will report precision-weighted rates of TIA clinic referral/ attendance and stroke in intersectional strata (e.g. Black men aged 51-75 living in the least deprived quintile of England) using Multilevel Analysis of Individual Heterogeneity and Discriminatory Accuracy (MAIHDA) logistic regression.
We will use model outputs to inform planned qualitative and co-production work with service users and the public to explore how TIA pathway access could be made more equitable for all. (www.fundingawards.nihr.ac.uk/award/NIHR162550).
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Epidemiology of Epidermolysis Bullosa in the UK — Zoe Venables ...
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Epidemiology of Epidermolysis Bullosa in the UK
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-05
Organisations:
Zoe Venables - Chief Investigator - University of East Anglia
Charlotte Davies - Corresponding Applicant - University of East Anglia
Jane Skinner - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Marta Kwiatkowska - Collaborator - University of East AngliaOutcomes:
Clinical outcomes:
-Incidence and prevalence of EB in the UK
-Mortality and survival of patients with EB
-Rate of EB-related comorbiditiesResource use (HRU) associated with EB:
-Number of primary care consultations
-Number of hospital admissions
-Number of prescribed medications for antidepressants, analgesics, dressings, and top 5 most frequently prescribed medication classes (BNF chapters) to patients with EB
-Number of âfit to workâ letters
-Number and proportion of blue badges issuedCost of the HRU associated with EB:
-Broad calculation of costs of above prescriptions and care costsOutcomes are defined and operationalised in the âExposures, Outcomes and Covariatesâ section
Description: Lay Summary
Epidermolysis Bullosa (EB) is a group of rare inherited skin disorders that cause the skin to become fragile and form blisters. It is usually diagnosed in babies and young children and in severe cases, can lead to early death. Little is known about how many people live with EB and how they are treated in the UK.
The project will use the Clinical Practice Research Datalink (CPRD) Aurum and Gold databases to study the information about EB such as how often patients with EB see General Practitioners (GPs) and how they are managed, including what treatment they receive. Hospital Episode Statistics (HES) data will be used to study hospital admissions and visits related to EB. Additionally, information about the deaths of patients with EB will be sourced from the Office for National Statistics (ONS). This information is essential for research and planning to improve healthcare services and the development of new treatments for EB.
Findings from this study will:
Technical Summary
1. improve our understanding of how common EB is in the UK
2. highlight how many people die from EB and for how long they survive after EB diagnosis
3. investigate other medical conditions that patients with EB suffer from and check how many sick notes or disability badges are given to patients with EB
4. help understand what medications and treatments are offered to patients with EB and the cost of these interventions to the NHSEpidermolysis Bullosa (EB) is a group of rare and currently incurable genetic skin conditions characterised by increased fragility and blistering of the skin. Patients with severe EB may experience symptoms in any epithelial-lined organ, which leads to significant morbidity and shortened life expectancy. The size and characteristics of the population in the UK who have EB is not well understood. Similarly, relatively little is known about the clinical pathways and treatments these patients receive to manage the symptoms of EB.
The project will use Clinical Practice Research Datalink (CPRD) Aurum and Gold linked to Hospital Episode Statistics (HES) and ONS databases to describe the point prevalence and incidence of EB per 1,000,000 PY with corresponding 95% confidence intervals. We will also describe the sociodemographic and clinical characteristics of patients with EB and subgroups of interest, reporting the numbers and percentages for categorical values and descriptive statistics for continuous variables. The proportion of patients who experience at least one instance of each mental health condition or receive a sick note will be examined using a delayed entry Cox regression. We will also compare disease-specific mortality rates (as proportions) and percentages of the 10 most common causes of death.
Counts of healthcare resource outcomes per patient will be described using overall categories and compared using separate negative binomial regression models. Total and median cost per patient will be described.
The study findings will benefit patients in the UK by filling a knowledge gap on the prevalence of different types of EB and treatment patterns and outcomes in affected individuals by highlighting the costs of managing and treating EB to the NHS. The results will contribute to a wider understanding of the value of focussing research and treatments in this area to improve patient outcomes and reduce demands on NHS resources.
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Understanding and Preventing Cardiovascular diseases in people prescribed AntiPsychotic medications: a data-driven study (PreCAP) — Yu Fu ...
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Understanding and Preventing Cardiovascular diseases in people prescribed AntiPsychotic medications: a data-driven study (PreCAP)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Yu Fu - Chief Investigator - University of Liverpool
Yu Fu - Corresponding Applicant - University of Liverpool
Carolyn Chew-Graham - Collaborator - Keele University
Dan Joyce - Collaborator - University of Liverpool
Iain Buchan - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
Primary
⢠CVD events: myocardial infarction, heart failure, angina, ischaemic heart disease, major coronary procedures, cerebrovascular events.
⢠Events of comorbidities with known CVD risks:
excess weight and obesity
hypertension
diabetes mellitus
dyslipidemia
chronic kidney disease
atrial fibrillation
migrainesSecondary
⢠Use of CVD primary prevention:
pharmacological interventions: lipid-lowering therapy, anti-hypertensive, glucose-lowering medications prescribing
lifestyle modification: weight management, smoking cessation, cardioprotective diet, alcohol consumption reduction
service provision: mental health annual physical examination, Health Check Programme, CVD risk score, care reviews
⢠Hospital Admissions: all-cause, CVD-related emergency department visits and inpatient stays.
⢠Mortality: Aall-cause-mortality, CVD-specific mortality including sudden cardiac death.Description: Lay Summary
Antipsychotic medications are important for treating mental health conditions, but they increase the risk of developing physical health problems, such as increased blood sugar and blood pressure. People who take antipsychotics are 2 to 4 times more likely to die from heart-related issues than those who do not. Despite the growing use of these medications, health services are effectively managing the heart health risks in these patients. The heart-related risks vary depending on the specific antipsychotic, but current treatments do not take these differences into account. As a result, people on antipsychotics often receive the same kind of care regardless of their specific needs, and disjointed care for their mental and physical health, which leads to poor long-term health outcomes and shorter life spans.
We aim to find ways to prevent heart disease in people taking antipsychotics. By analysing anonymised healthcare data from UK patients, we will look at the differences in heart health risks and care between people prescribed different antipsychotics and those who are not. We will take account into factors that are related to the risk of heart disease, including patient factors like age and ethnicity, health factors like high blood sugar and high blood pressure, and care provided to prevent heart disease, such as the use of cholesterol-lowering medications.
This study will help us understand the risks of heart disease in people on antipsychotics. Using this knowledge, we will find practical ways to help them receive the right care for both their mental and physical health.
Technical SummaryThis study aims to explore variations in CVD risk across antipsychotics and gaps in primary prevention to enhance CVD prediction in people prescribed antipsychotics.
Objectives
1. Quantify CVD events, risks and comorbidities increasing CVD risks attributed to antipsychotics;
2. Examine gaps in CVD primary prevention;
3. Develop and validate a CVD risk model for individuals prescribed antipsychotics.
Design
Retrospective matched-cohort study.
Methods
CPRD Aurum will include patients aged â¥18 without pre-existing CVD and â¥1 year of follow-up from 01/01/2006. Two matched cohorts will be created: antipsychotic users (exposed) and unexposed controls. Controls will be matched to exposed patients by practice, age, gender, and calendar time, with the reference time point aligned to the exposed cohortâs first prescription date to ensure baseline comparability.
Descriptive statistics will summarise baseline characteristics. Regression models, adjusted for baseline characteristics and time-varying covariates, will analyse outcomes at 1, 3, 5, and 10 years using linear mixed-effects, generalised linear mixed, ordinal logistic regression, and Cox proportional hazards. Logistic regression, Poisson/negative binomial regression, and Cox models for time-to-event outcomes will be undertaken. A tailored model with antipsychotic-specific and traditional risk factors will be internally validated with 1,000 bootstrap resamples in CPRD Aurum and externally validated with CPRD GOLD. Performance metrics (calibration plots, Brier scores, C-statistic) will compare to QRISK. Confounders will be adjusted using regression and directed acyclic graphs, with two-level models addressing GP practice clustering.
Outcomes
The primary outcomes are CVD events and comorbidities with known CVD risk. The secondary outcomes are use of CVD primary prevention, hospital admissions and mortality. With linked datasets, we will determine how different antipsychotics contribute to CVD development, incorporating key patient, clinical, and care factors, compared to unexposed patients. Quantifying CVD risk by antipsychotic pharmacology and patient factors, and identifying prevention gaps offer opportunities for improving CVD prediction/early targeted intervention/health policies.
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Utilization and longitudinal trends in prescribing of medications for pain management in the United Kingdom — Nazleen Khan ...
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Utilization and longitudinal trends in prescribing of medications for pain management in the United Kingdom
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-19
Organisations:
Nazleen Khan - Chief Investigator - Merck & Co. Inc - Pennsylvania, USA
Nazleen Khan - Corresponding Applicant - Merck & Co. Inc - Pennsylvania, USA
Aristide Merola - Collaborator - Merck & Co., Inc.
Tammy Jiang - Collaborator - Merck & Co. Inc - Pennsylvania, USAOutcomes:
Medication utilization will be defined based on prescription of opioids, non-steroidal anti-inflammatory drugs, paracetamol, skeletal muscle relaxants, gabapentinoids, duloxetine, and amitriptyline. Prescription medications will be identified based on the Gemscript product code system in CPRD GOLD.
Prescription opioids: Buprenorphine, Butorphanol, Codeine, Dihydrocodeine, Fentanyl, Hydrocodone, Hydromorphone, Levorphanol, Meperidine, Methadone, Morphine, Opium, Oxycodone, Oxymorphone, Pentazocine, Propoxyphene, Tapentadol,
Tramadol
Non-steroidal anti-inflammatory drugs: Celecoxib, Diclofenac, Diflunisal, Etodolac, Fenoprofen, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac, Meclofenamate, Mefenamic acid, Meloxicam, Nabumetone, Naproxen, Oxaprozin, Piroxicam, Sulindac, Tolmetin
Paracetamol: Paracetamol
Skeletal muscle relaxants: Baclofen, Carisoprodol, Cyclobenzaprine, Metaxalone, Methocarbamol, Tizanidine, Chlorzoxazone, Orphenadrine
Gabapentinoids: Gabapentin, Pregabalin
Duloxetine: Duloxetine
Amitriptyline: AmitriptylineDescription: Lay Summary
Acute and chronic pain, if unresolved or inadequately treated, lead to significant health burden that may involve overuse of potent medications with abuse potential and poor quality of life. Limited data are available on population-level prevalence and longitudinal trends of pain medication use in the UK. Study objectives are to use data from the UK Clinical Practice Research Datalink (CPRD) GOLD to (1) quantify the prevalence of prescription opioid, non-steroidal anti-inflammatory drug, paracetamol, skeletal muscle relaxant, gabapentinoid, duloxetine, and amitriptyline use in 2023 in the UK at a population level and in subgroups of patients with chronic pain conditions (i.e., persistent pain lasting more than 3 months); (2) quantify the prevalence of these medications in 2019 in the UK in patients who underwent total joint replacement surgery and spine surgery, respectively; and (3) assess population-level temporal trends in the prescription of these medications in the UK from 1997-2023. Capturing these data will help to understand the present landscape of pain medication utilization; potential regional shifts in pain management and prescribing practices; and characteristics of patients who may benefit from alternatives to currently available medications.
Technical SummaryAcute and chronic pain, if unresolved or inadequately treated, lead to significant health burden that may involve overuse of potent medications with abuse potential and poor quality of life. Limited data are available on population-level prevalence and longitudinal trends of pain medication use in the UK. Study objectives are to use data from the UK Clinical Practice Research Datalink (CPRD) GOLD to (1) quantify the prevalence of prescription opioid, non-steroidal anti-inflammatory drug, paracetamol, skeletal muscle relaxant, gabapentinoid, duloxetine, and amitriptyline use in 2023 in the UK at a population level and in subgroups of patients with osteoarthritis, chronic low back pain, and diabetic peripheral neuropathy; (2) quantify the prevalence of these medications in 2019 in the UK in patients with total joint replacement surgery and spine surgery, respectively; and (3) assess temporal trends in the prescription of these medications in the UK from 1997-2023. For the subgroup of patients with select surgical procedures, the CPRD GOLD data will be linked to the hospital episode statistics admitted patient care (HES-APC) file for information on hospital admissions and prescribed treatments in 2019 before the COVID-19 pandemic. The study population will consist of individuals with complete registration information from January 1st-December 31st of a given calendar year in UK CPRD GOLD and aged >= 19 years in the same calendar year. No exposures will be assessed in this study. Medication utilization outcomes will be defined based on prescription of eligible opioids, non-steroidal anti-inflammatory drugs, paracetamol, skeletal muscle relaxants, gabapentinoids, duloxetine, and amitriptyline in CPRD GOLD. One-year prevalence of select prescription medication use will be quantified using proportions and 95% confidence intervals at the population level and for all subgroups. Temporal trends in pain medication prescribing will be captured annually using proportions and 95% confidence intervals from 1997-2023 at the population level.
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The bidirectional association between functional disorders and adverse pregnancy outcomes — Nicola Adderley ...
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The bidirectional association between functional disorders and adverse pregnancy outcomes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-02-12
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Qinyin Li - Corresponding Applicant - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
Kelvin Okoth - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Megha Singh - Collaborator - University of BirminghamOutcomes:
Functional disorders:
Irritable bowel syndrome
Functional dyspepsia
Globus
Fibromyalgia
Chronic fatigue syndrome
Interstitial cystitis/painful bladder syndrome
Temporomandibular joint disorders
Vulvodynia
Chronic prostatitis
Tension-type headache
Myofascial pain syndrome
Restless legs syndromeAdverse pregnancy outcomes:
Miscarriage
Hyperemesis gravidarum
Ectopic pregnancy
Hypertensive disorders of Pregnancy (Gestational hypertension, Pre-eclampsia, Eclampsia)
Gestational diabetes mellitus
Post-partum depression
Obstetric haemorrhage
Cesarean section
Stillbirth
Placental abruption
Pre-term birth
Small for gestational age
Large for gestational age
Low birth weight
Chorioamnionitis
Premature preterm rupture of membranes
Intrauterine growth restrictionDescription: Lay Summary
Functional disorders (FDs) is a medical condition where symptoms are real, yet no structural or biochemical abnormality can be detected through conventional diagnostic tests, often happen when the central nervous system becomes unusually sensitive. This tends to be more common among women during their childbearing years and has been linked to pregnancy complications. Some studies even suggest that women who experience pregnancy complications may face a higher risk of developing FDs later on. This study aims to explore this two-way connection.
Technical Summary
First, we'll look at how common FDs are in pregnant women by reviewing their health records. Then, we'll examine how often women with FDs experience pregnancy-related health issues, aiming to understand how FDs might impact both the motherâs and babyâs health. Additionally, weâll investigate whether women with pregnancy complications have an increased likelihood of developing FDs in the future.
This study aims to support healthcare providers, patients, and families in planning pregnancy care for women with FDs, as well as guide post-pregnancy care for women who have had complications, helping reduce the chances of related FDs developing.The aim of this study is to investigate the bidirectional association between functional disorders (FDs) and adverse pregnancy outcomes (APOs). First, we will estimate the prevalence of FDs among pregnant women within the CPRD Pregnancy Register, utilizing diagnostic codes for a list of 12 common FDs identified through a comprehensive literature review. Similarly, a list of 17 common APOs has been identified and will be classified by diagnostic codes.
The study will proceed in two phases:
Study 1: Using the CPRD Pregnancy Register, cohort of pregnancies will be established. This phase will estimate the incidence of APOs among women with pre-existing FDs compared to those without FDs.
Study 2: This phase will examine whether women who experience APOs are at a higher risk of developing FDs. APOs will be ascertained through both primary care records and linked HES data. To quantify the association between each FD and APO pair, a matrix of odds ratios will be generated based on logistic regression models, adjusted for relevant covariates.
This study aims to clarify the bidirectional association between FDs and APOs, providing clinicians with insights for developing targeted strategies and healthcare pathways that may help mitigate these outcomes.
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ID-508: NIPP CKD Evaluation — Imperial College Healthcare NHS Trust...
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ID-508: NIPP CKD Evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: CKD.
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ID-511: Brent Health Evidence & Insight Access for JSNA and Other Public Health Inequality Projects — Brent Council...
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ID-511: Brent Health Evidence & Insight Access for JSNA and Other Public Health Inequality Projects
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Brent Council
Description: Brent.
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Re-ID-004: National Neighbourhood Implementation Programme in Bi-Borough — Covent Garden Medical Practice...
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Re-ID-004: National Neighbourhood Implementation Programme in Bi-Borough
Legal basis:re-identification
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Covent Garden Medical Practice
Description: NNHIP.
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ID-452-4: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy — Imperial College NHS Healthcare Trust...
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ID-452-4: Extension: Exploring the impact of family size on child health outcomes and service use in North West London: An analysis to inform local service provision and national welfare policy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Family size.
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ID-412-3: Extension: Inequalities in Mental Healthcare Services: A Mixed-Method Approach Identifying Actionable Measures to Monitor Inequalities and Inform Improvement Efforts — Imperial College London...
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ID-412-3: Extension: Inequalities in Mental Healthcare Services: A Mixed-Method Approach Identifying Actionable Measures to Monitor Inequalities and Inform Improvement Efforts
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental health.
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ID-407-3: Extension: Evaluation of virtual consultations in primary care: assessing the effectiveness of eConsult — Imperial College London...
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ID-407-3: Extension: Evaluation of virtual consultations in primary care: assessing the effectiveness of eConsult
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: eConsult.
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ID-151-8: Extension: Care coordination for Adolescents in Crisis — Imperial College London...
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ID-151-8: Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental health.
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ID-448: Clinical Outcomes and Cost of OSA in OUS Settings — Imperial College Healthcare Partners...
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ID-448: Clinical Outcomes and Cost of OSA in OUS Settings
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare Partners
Description: OSA. Commercial (DOUBLE CHECK)
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ID-473-1: Extension: Adult Critical Care Analysis — NHS England...
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ID-473-1: Extension: Adult Critical Care Analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: NHS England
Description: Adult care.
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ID-510: Evaluation of Colorectal Endoscopic (EMR/ESD) and Surgical Resection Activity in North West London: A WSIC Service Evaluation — Imperial College Healthcare NHS Trust...
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ID-510: Evaluation of Colorectal Endoscopic (EMR/ESD) and Surgical Resection Activity in North West London: A WSIC Service Evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Colorectal Activity.
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ID-507: Characterising Cardiovascular Kidney Metabolic (CKM) Health Profiles, healthcare utilisation and treatment in North West London — Imperial College Healthcare NHS Trust...
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ID-507: Characterising Cardiovascular Kidney Metabolic (CKM) Health Profiles, healthcare utilisation and treatment in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Kidney profiles.
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ID-426-2: Extension: TRICORDER-PLUS — Imperial College Healthcare NHS Trust...
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ID-426-2: Extension: TRICORDER-PLUS
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart health.
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ID-352-7: Extension: North West London Integrated Care Board (ICB) Research And Innovation Project. — Imperial College Health Partners...
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ID-352-7: Extension: North West London Integrated Care Board (ICB) Research And Innovation Project.
Legal basis:Research and Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Multimorbidity, acute care, and mental health.
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ID-449: Hounslow befriending initiative – service evaluation and analysis — London Borough of Hounslow...
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ID-449: Hounslow befriending initiative – service evaluation and analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: Hounslow.
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ID-506: The potential health and resource use impact of alternative stratergies for managing obesity — Imperial College Healthcare NHS Trust...
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ID-506: The potential health and resource use impact of alternative stratergies for managing obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: obesity. Commercial
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ID-427-2: Extension: Detecting and treating CKD at the earliest stages — Imperial College Healthcare NHS Trust...
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ID-427-2: Extension: Detecting and treating CKD at the earliest stages
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: CKD.
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ID-447 – Hounslow Community Falls – service evaluation and analysis — London Borough of Hounslow...
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ID-447 – Hounslow Community Falls – service evaluation and analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: Hounslow.
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ID-486-1: Clinical impact and healthcare utilisation of a digital long term conditions self-management platforms (Know Diabetes / Preventing Diabetes / MyHealth London): a mixed-methids evaluation — NHS Greater Glasgow and Clyde/ MyWay Digital Health...
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ID-486-1: Clinical impact and healthcare utilisation of a digital long term conditions self-management platforms (Know Diabetes / Preventing Diabetes / MyHealth London): a mixed-methids evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: NHS Greater Glasgow and Clyde/ MyWay Digital Health
Description: healthcare utilisation.
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ID-174-5: Extension: Children & Young People JSNA (CYP JSNA) — London Borough of Brent...
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ID-174-5: Extension: Children & Young People JSNA (CYP JSNA)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: London Borough of Brent
Description: JSNA.
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ID-509: 0 to 5 years development data exploration — Westminster and Kensington and Chelsea Council...
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ID-509: 0 to 5 years development data exploration
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Westminster and Kensington and Chelsea Council
Description: development data.
Source -
ID-446: Patient characteristics, health and social care resource utilisation and costs among community COVID-19 infections in North West London — Lane Clark & Peacock LLP...
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ID-446: Patient characteristics, health and social care resource utilisation and costs among community COVID-19 infections in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: COVID-19. Commercial
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ID-417-1: Extension: Transforming Women’s Health: mapping out pathways and trajectories — Imperial College Health Partners...
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ID-417-1: Extension: Transforming Women’s Health: mapping out pathways and trajectories
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Women’s health. Commercial
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ID-132-1: Extension: Pilot intervention for young self-harm patients in NWL — Imperial College London...
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ID-132-1: Extension: Pilot intervention for young self-harm patients in NWL
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Self-harm.
Source
2025 - 01
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— unknown...
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Where: unstated
When: 2025-1-16
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding three Research Fellows to analyse the Annual Survey of Hours and Earnings (ASHE) linked to the Census 2011 dataset. Their policy-relevant projects are investigating wage dynamics, employment patterns, and workforce inequality. The projects are the result of ADR UK Fellowship opportunities which invited applications to carry out research using eligible ADR England flagship datasets.
The ASHE, conducted annually by the Office for National Statistics (ONS) in April, is the UK's most comprehensive source of information on earnings structure and distribution, providing insights into the levels, distribution, and composition of earnings across all industries and occupations. The census is carried out by the ONS every ten years, and offers a detailed snapshot of the population and households in England and Wales. Linking ASHE to Census 2011 allows for insight into the dynamics of wage and employment issues, and how characteristics such as gender, disability, and ethnicity influence these. This linked dataset was developed as part of the Wage and Employment Dynamics project to aid better understanding of wage inequalities in Britain.
The fellows are using use this dataset to examine issues such as the disability pay gap, the influence of hiring discrimination on skills and outcomes for workers, and how geographic factors affect job mobility for workers of different educational levels. Fellows are accessing the de-identified dataset via the ONS Secure Research Service.
Learn more about the Research Fellows and their projects below.
Â
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— unknown...
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Where: unstated
When: 2025-1-31
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding five Research Fellows to conduct research and analysis using the Ministry of Justice (MoJ) & Department for Education (DfE) linked dataset. They will uncover insights into how educational factors contribute to young peoplesâ interactions with the criminal justice system. The projects are the result of ADR UK Fellowship opportunities which invited applications to conduct research using eligible ADR England flagship datasets.
The MoJ-DfE linked dataset represents a significant resource for understanding the intersection of childhood characteristics, educational experiences, and criminal justice involvement among young people. The dataset includes data from prison, courts, Police National Computer, National Pupil Database, Early Years Foundation Stage Profile, looked after children, and children in need. It covers variables such as demographics, offending data, school exclusions, and all episodes of children in care.
Each research fellow will conduct an independent study focused on a range of questions related to the links between young peopleâs educational experiences and offending behaviour. They aim to inform policy and practice in both the educational and justice systems, and improve outcomes for young people.
Learn more about the Research Fellows and their projects below.Â
Dr Hannah Dickson Optimising the risk assessment of violent reoffendingHannah is a Senior Lecturer at the Department of Forensic and Neurodevelopmental Science, Kingâs College London. This project aims to use educational information to improve risk assessments of violent reoffending. The word recidivism used below is another word for reoffending.
Source -
— unknown...
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Where: unstated
When: 2025-1-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: The aim of this project is to assess how wider adversities affect the health and survival of mothers with perinatal mental health conditions in Northern Ireland.
The project will:
Assess the sociodemographic and socioeconomic factors contributing to perinatal mental health conditions, and the impact of these on mothersâ health and survival outcomes (e.g. higher mental health medication use and/or hospital admissions) Investigate if domestic abuse is associated with the health and survival outcomes of mothers with perinatal mental health conditions Evaluate the relationship between mothersâ interactions with social services in childhood and the health and survival outcomes of mothers with perinatal mental health conditions Explore the extent to which wider adversities (i.e. socioeconomic inequalities, socio-demographic factors, interactions with social services in childhood, and domestic abuse) contribute to the health and survival outcomes of mothers with perinatal mental health conditions Evaluate if the motherâs health status during the perinatal period is an indicator of their future mental health status.This project, led by researchers at ADR Northern Ireland, investigates how social inequalities and domestic abuse affect the health and survival of mothers with mental health conditions during pregnancy and after childbirth in Northern Ireland.
Perinatal mental health conditions, including depression, anxiety disorders, postpartum psychosis, and bipolar disorder, occur during pregnancy or within the first year of giving birth. They affect up to 27% of new and expectant mothers and are a leading cause of maternal death during and after pregnancy, with long term consequences for mothers, babies, and families.
There is little research on how these conditions, combined with wider adversities like social inequalities, socio-demographic factors, mothersâ interactions with social services when they were children, and domestic abuse, affect mothersâ health and survival outcomes.
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— unknown...
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Where: unstated
When: 2025-1-20
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: The aim of this project is to develop a new linked dataset to enable a systematic, empirical examination of mental health and substance addiction among people in prison in Northern Ireland and the risk of mortality following their release into the community. Initially, the project will:
examine mental health issues among people in prison, describe the causes of death for people following release from prison, and characterise who is most at risk of death after release and which factors affect this risk (e.g. mental health).This ADR Northern Ireland project aims to develop a new linked dataset containing information on mental health and addiction among people in prisons in Northern Ireland, as well as their mortality risk following release.Â
People in prison tend to have higher rates of mental and physical health conditions. Studies have shown that substance use disorders are common within the prison population, and individuals face an increased risk of drug-related death after release.Â
Further research specific to Northern Ireland is needed to improve our understanding about the health challenges faced by people in prison and following their release.
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— unknown...
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Where: unstated
When: 2025-1-20
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to evaluate the effectiveness of the Northern Ireland Multiple Deprivation Measure 2017. By investigating how well this measure reflects and predicts the social, health, and economic challenges faced by Northern Irelandâs population, the research will provide insights to inform future updates â ensuring it remains a reliable tool for researchers and policymakers.
Small-area deprivation measures have been widely used in the UK to understand inequalities in health since the 1980s. In Northern Ireland (NI), the current measure used to capture area-level deprivation is the NI Multiple Deprivation Measure (NIMDM) 2017.
Researchers and policymakers have, for some time, used data derived from this measure to understand and attend to the social, educational, health and economic needs of the NI population. Like other multiple deprivation measures, this measure has evolved over time and currently attempts to capture both overall deprivation and deprivation across seven distinct domains: Income, Employment, Health & Disability, Education, Skills & Training, Access to Services, Living Environment, and Crime & Disorder.
However, with the recent update to NI geography in the most recent NI Census (reducing 890 Super Output Areas to 850 Super Output Zones), the NIMDM 2017 is now outdated. In addition, although literature describes how the measure was designed and developed, no known data-driven approach has been employed to investigate whether the NIMDM 2017 reliably 1) represents deprivation or 2) predicts health outcomes.
Source -
— unknown...
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Where: unstated
When: 2025-1-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding an 18-month Research Fellowship to use a new linked dataset combining the Annual Survey of Hours and Earnings (ASHE) with PAYE (Pay As You Earn) and Self-Assessment data from His Majesty's Revenue & Customs (HMRC). The project is the result of an ADR UK Fellowship opportunity which invited applications to carry out research using eligible ADR England flagship datasets.
The linked dataset was developed as part of the Wage and Employment Dynamics project to aid better understanding of wage inequalities in Britain. Linking ASHE to PAYE and Self-Assessment data offers a more comprehensive view of individuals' employment and income, such as income from self-employment as well as salaried work. The linked dataset also helps to address the information gaps between annual ASHE surveys conducted by the Office for National Statistics (ONS). ASHE linked to PAYE and Self-Assessment data is accessed via the ONS Secure Research Service.
By analysing this linked dataset, the following project aims to shed light on the prevalence and patterns of multiple employment, the financial risks involved, and how local labour market conditions affect these work arrangements. This research will provide valuable evidence to inform labour market policies, particularly around low-paid and casual work.
Dr Darja Reuschke Uncovering patterns and policy implications of how employee jobs and self-employment are combinedDarja, an Associate Professor at the University of Birmingham, is investigating how employees combine salaried jobs with self-employment, an under-researched area of the labour market. In collaboration with the Womenâs Budget Group, the research will focus on the financial constraints and risks faced by workers in these dual roles, particularly women.
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— unknown...
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Where: unstated
When: 2025-1-22
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Only 55% of cancers are currently detected early, highlighting the need for improved prevention, early detection and diagnosis. Increasing availability of diverse, individual-level linked data from population-scale electronic health records, administrative data sources and large-scale cohort studies, along with advances in statistical and machine-learning approaches, offer new opportunities to identify novel cancer risk factors and improve cancer risk assessment.Â
Cancer Research UK is leading a new, UK-wide initiative to leverage these advances. Cancer Data Driven Detection aims to deepen our understanding of who is most at risk of developing cancer and hence improve prevention, early detection and diagnosis.Â
ADR UK is providing in-kind support to Cancer Data Driven Detection by funding a project using linked administrative and health data to understand the incidence of breast and bowel cancer in Wales. By integrating several sources of data, the project will identify patterns and inequalities in cancer occurrence and screening. These findings will support researchers, policymakers, and health professionals in addressing disparities in cancer diagnosis, care, and outcomes.Â
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— unknown...
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Where: unstated
When: 2025-1-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding seven Research Fellows to analyse the Education and Child Health Outcomes from Linked Data (ECHILD) dataset. These projects are exploring the relationship between childrenâs health and education, generating insights that could inform policy decisions to improve support for children. The projects are a result of ADR UK Research Fellowship opportunities which invited applications to carry out research using eligible ADR England flagship datasets.
ECHILD contains linked, de-identified records for around 20 million children and young people in England. It is made up of the National Pupil Database (including data on pupil and school characteristics, educational outcomes and social care) linked to healthcare data. This includes Hospital Episode Statistics, birth notifications, maternity services data, mental health data and community services data. The dataset can be used to better understand how education affects childrenâs health, and how health affects childrenâs education.
ECHILD also contains linked health, education and social care data on the mothers of ECHILD cohort members through a mother-baby link. This enables researchers to investigate the effects of maternal exposures on childrenâs outcomes.
The fellows are addressing a range of policy-relevant questions. They are accessing the dataset via the Office for National Statistics (ONS) Secure Research Service.
Learn more about the Research Fellows and their projects below.
Dr Hope Kent Educational outcomes after paediatric brain injuries and the role of special educational needs supportÂHope is a Postdoctoral Research Associate at the University of Exeter. Her project aims to understand how acquired brain injury impacts outcomes for children in the education system, and the role of special educational needs support in improving these outcomes. Â
Source -
— unknown...
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Where: unstated
When: 2025-1-9
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding two Research Fellows to use the newly available Administrative Data | Agricultural Research Collection (AD|ARC) dataset to explore the socioeconomic characteristics and economic resilience of farming households. The successful Research Fellows, and the projects they carry out, are part of the ADR UK Fellowship programme, which promotes research using ADR UK flagship datasets.
The AD|ARC dataset links information on farming activities with de-identified demographic and socio-economic data from farm households, together with control groups of non-farming individuals in rural areas. By combining these datasets, with additional linkages to health data, researchers can generate new insights into the business-family-place dynamic regarding the socio-economic characteristics, business resilience, health and wellbeing of farming communities.
The Research Fellowsâ projects will focus on farm household income and resilience, as well as explore their demographic and business profiles to learn how these characteristics influence engagement with support schemes and health outcomes. These findings will deepen our understanding of the challenges faced by farming households, with the potential to inform agricultural and rural policy and improve the wellbeing of farm communities.
Read more about the AD|ARC Research Fellows and their projects below.
Professor Paul Wilson Farm household resilience, income source and earningsPaul is a Professor of Agricultural Economics at the University of Nottingham. Paulâs project will estimate and model farm household income, reliance on subsidies, and other income sources in relation to farm household composition and characteristics. The project will compare farm household financial hardship with that of non-farm rural households in England and Wales. Â
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A study to examine the feasibility of examining medication-related risks of delirium hospital admissions in people with dementia — Kathryn Richardson ...
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A study to examine the feasibility of examining medication-related risks of delirium hospital admissions in people with dementia
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-28
Organisations:
Kathryn Richardson - Chief Investigator - University of East Anglia
Kathryn Richardson - Corresponding Applicant - University of East Anglia
Katharina Mattishent - Collaborator - University of East Anglia
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Emergency hospital admission with delirium; prescription of key medications (antidepressants, overactive bladder medications, antipsychotics, benzodiazepines/z-drugs, opioids, and acetylcholinesterase inhibitors); change in residence after a delirium hospital admission
Description: Lay Summary
It is uncertain whether taking certain medications can increase or decrease the risk of delirium in people with dementia.
We aim to complete this feasibility study to first see if the number of patients with delirium reported during hospital admissions in people with dementia is similar to what other studies report. Secondly, we would like to check if there are enough people with dementia prescribed the specific medications of interest to examine their risk of delirium admission in a future study. The medicines we intend to look at are those to treat: depression, sleep disturbance, bladder issues, behavioural disturbance/psychosis, pain, and those to help slow the progression of Alzheimerâs disease.
The information gained from the future study should lead to changes in prescribing guidelines to improve the care of people with dementia.
Technical SummaryWe aim to complete this feasibility study to examine if there are sufficient data to examine the prescription of specific medications and the risk of delirium admission in people with dementia in a future study.
First we will select all patients with a previous diagnosis of dementia (in CPRD or HES APC) or previous prescription for a cognitive enhancer, and have GP registration in England at any time since Jan 2010. We will count the number of emergency hospital admissions they have since the dementia diagnosis (and between Jan 2010-March 2023), by year, and how many of them have a record of delirium noted (ICD-10 codes F05 or R41.0). We will count how many occurred on admission by excluding those that occurred after surgery (via OPCS codes). We will also examine counts using a broader definition of delirium by also including ICD-10 codes for encephalopathy terms.
Second, we will provide a count of how many of these patients have record of a delirium admission and also prescription of each of the following different medications on or after their dementia diagnosis date: antidepressants, overactive bladder medications, antipsychotics, benzodiazepines/z-drugs, opioids, and acetylcholinesterase inhibitors. We will also look at these counts by gender and ethnicity group.
Third, we are also interested in how many people with dementia change their residence after a delirium hospital admission. So will look at how often a change in discharge destination is noted on the HES APC discharge information.
We will not report any counts where there are <10 patients.
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Deprescribing statins in older adults for the primary and secondary prevention of major cardiovascular events: Protocol for two non-inferiority trial emulation studies — James Wason ...
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Deprescribing statins in older adults for the primary and secondary prevention of major cardiovascular events: Protocol for two non-inferiority trial emulation studies
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-10
Organisations:
James Wason - Chief Investigator - Newcastle University
Shaun Hiu - Corresponding Applicant - Newcastle University
Adam Todd - Collaborator - Newcastle University
Ellen Moss - Collaborator - Newcastle University
Enoch Akowuah - Collaborator - South Tees Hospitals NHS Trust
Rachel Smith - Collaborator - Cambridge University HospitalsOutcomes:
MACE is defined as a fatal or non-fatal stroke, transient ischaemic attack, myocardial infarction, or having received a coronary or carotid intervention (percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or carotid endarterectomy (CEA)); the competing event of death not due to MACE is defined as any death due to reasons other than MACE.
Description: Lay Summary
Statins are a group of medicines that lower a type of cholesterol in a personâs blood. We know that high cholesterol can increase the risk of a person having a stroke or a heart attack. Taking statins can reduce this risk, but may cause side effects. As people get older, it is not clear if statins are still needed â or if it is safe to stop them after a certain amount of time.
Clinical trials provide the highest quality evidence for healthcare authorities to make recommendations for clinical practice. However, there are no clinical trials of stopping statins in older people. Carrying out a clinical trial to investigate this would be very complicated, lengthy, and expensive. Target trial emulation is a type of study that attempts to closely mimic the features of a clinical trial, allowing researchers to get an answer close to what the trial would have given if it had been conducted. To do this, it is important to have access to prescribing data where statins are started or stopped as part of routine clinical practice. We will use the Clinical Practice Research Datalink to access this data.
This research aims to answer if it is safe to stop statins in older people. We will investigate if stopping statins increases the risk of a person experiencing a major cardiovascular event (e.g. heart attack). Our results will hopefully help healthcare professionals make better prescribing decisions about when to review and stop statins in older people.
Technical SummaryOur primary objective is to investigate if statins may be âsafelyâ deprescribed amongst older adults with or without a prior history of major adverse cardiovascular events (MACE) by emulating two non-inferiority trials - one in primary prevention and secondary prevention. A non-inferiority (NI) margin of 1.10 on the relative risk (RR) scale is pre-specified. We will use data spanning 01-January-2000 to 29-February-2020 from the Clinical Practice Research Datalink (CPRD) GOLD database.
MACE is defined as a fatal or non-fatal stroke, transient ischaemic attack, myocardial infarction, or having received a coronary or carotid intervention. Participants must be â¥65 years of age, have >=1 day of an active statin prescription in the last 90 days, and have been prescribed statins for >=12 months over their lifetime. Eligible patients in the primary prevention emulation must have no history of MACE whereas eligible patients in the secondary prevention emulation must have a history of MACE. Patients are assigned to the control arm if there was at least one day of an active statin prescription in the last 120 days (continuing statins) and to the intervention arm if there was no active prescription of any statin in the last 84 days (deprescribing statins). Our primary outcome is first-ever MACE for the primary prevention and first recurrent MACE for the secondary prevention emulation respectively, with competing event for death not due to MACE within a 10-year follow-up.
We will analyse the data using discrete, competing risks, causal survival analysis methods (parametric g-formula) and report the 10-year causal risk ratio (and 95% confidence interval) of deprescribing statins (versus continuing) on MACE.
Hospital Episode Statistics (HES) data will be used to help define the MACE outcome. Area and patient-level deprivation data will be used as a covariate.
See "Sample size considerations" section for intended public benefit.
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Measuring inequalities in Type 2 diabetes and glucagon-like peptide-1 receptor agonist treatment in the England: a population based study — Emily Herrett ...
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Measuring inequalities in Type 2 diabetes and glucagon-like peptide-1 receptor agonist treatment in the England: a population based study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-06
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Giulia Seghezzo - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Carlos Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Prevalence (proportion) of Type 2 Diabetes; Demographic characteristics: age, sex, ethnicity, IMD quintile, region; Clinical characteristics: BMI, HbA1C, athersclerotic cardiovascular disease, retinopathy, dyslipedemia, diabetic ketoacedosis, eGFR, sleep apnea, hypertension, heart failure, myocardial infarction, peripheral arterial disease, cerebrovascular disease, coronary heart disease, NAFLD, liver disease; Uptake (proportion) in diabetic drugs; Uptake (proportion) in prescribing of GLP-1 RA; rate of hospitlisation due to adverse effects of GLP-1 RA
Description: Lay Summary
Type 2 diabetes is a growing public health challenge in England, and a common chronic condition where blood sugar is too high. There is a known connection with being overweight being a risk factor for type 2 diabetes, and furthermore, it is known that there are disparities with both these conditions, with increased numbers of obesity and diabetes among those who are more socially deprived or from ethnic minorities.
The National Institute for Health and Care Excellence (NICE) recommends glucagon-like peptide-1 receptor agonists (GLP-1 RA) for use in diabetic control and for weight-loss management, as they are a promising drug for blood sugar control and weight reduction. Originally intended for use in Type 2 diabetes, GLP-1 RAs have been shown to be useful in weight management among non-diabetic individuals, recently being recommended by NICE for weight loss in 2020.
This study will use electronic health records from GP practices to describe the trend of type 2 diabetes and obesity within type 2 diabetes, in adults, and understand the patient group characteristics of those being prescribed GLP-1 RA medication accordingly. It is important to understand which individuals are not yet receiving the medication when they should be eligible to. Understanding any disparities in the prevalence of the disease, and disparities in the prescribing of the medication can help inform policy decisions on where to best allocate the medication, ensuring those who can benefit most are able to receive it.
Technical SummaryTreatments such as glucagon-like peptide-1 receptor agonists (GLP-1 RA) offer both glycaemic control and weight reduction and gaining approval in the UK in 2006. Following recommendations from the National Institute of Health and Care Excellence (NICE) in 2020, GLP-1 RAs are now being prescribed for weight management in non-diabetic individuals, after showing benefits outside the diabetic community. Obesity is a growing public health concern in the UK, being a known risk factor for type 2 diabetes.
The aim of this study is to understand the prevalence and disparities of type 2 diabetes in adults, and the subsequent trends in the prescribing of GLP-1 RA following NICE recommendations. This study will use data from the clinical practice research datalink (CPRD) to carry out a descriptive study to investigate the prevalence of type 2 diabetes, the characteristics among this group, and the characteristics for prescribing of GLP-1 RA, such as age, sex, ethnicity, region, deprivation and morbidities to understand their impact on the receipt of NICE recommended treatments. Descriptive statistics such as means, proportions and counts will be used to describe the study population, and further logistic regression analyses will be used to determine factors associated with GLP-1 RA prescription. Data from hospital episode statistics will be used to understand outcomes following GLP-1 RA prescription. This study will look over time, understanding the impact of guideline publication and health alerts on prescribing patterns.
In the UK, where the prevalence of diabetes is high, understanding the disparities among disease prevalence, and patterns of GLP-1 RA use is crucial in shaping future health policy. Disparities in access to these medications could exacerbate existing health inequalities. Investigating these patterns is essential to ensure equitable healthcare delivery and to inform policy decisions on the appropriate use of GLP-1 RA across different patient groups.
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Diagnosis and management of vitamin B12 deficiency across primary care in England — Martin Warren ...
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Diagnosis and management of vitamin B12 deficiency across primary care in England
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Martin Warren - Chief Investigator - University of East Anglia
George Savva - Corresponding Applicant - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Paul Kroon - Collaborator - Quadram Institute
Rachel Barnes - Collaborator - Quadram InstituteOutcomes:
Tests of vitamin B12 levels;
Test for anti-intrinsic factor antibodies;
Test for anti-parietal cell antibodies;
Test of methylmalonic acid level;
Test of homocysteine level;
Diagnosis of pernicious anaemia;
Prescriptions of vitamin B12 replacement therapies;
Administration of vitamin B12 injections;
Referrals to gastrological and neurological services;
Symptoms of vitamin B12 deficiency;Description: Lay Summary
Vitamin B12 deficiency affects up to one in five of older people in England. B12 is essential for healthy blood and nervous system function and, if untreated, B12 deficiency can cause serious complications like chronic fatigue, pain and neurological problems.
Diagnosis is done by a blood test. Either total or active serum B12 is measured along with other tests that can help to understand the cause of the deficiency and how it should be managed.
Deficient patients may then receive supplements by tablets or by injections of B12 every eight to twelve weeks. For some this will improve symptoms but many still experience symptoms and seek more frequent injections. A recent review ahead of updated guidance on the diagnosis and management of B12 deficiency found little evidence to guide optimal treatment or follow up.
Little is known about how GPs test, investigate and treat vitamin B12 deficiency in practice, or how many patients continue to experience symptoms despite being on treatment.
In this study we will describe the current primary care practice with respect to B12 testing and management in the past ten years, and how this varies across communities and over time. This will show current practices and possible gaps affecting patient experience.
Technical SummaryThis is a descriptive study of the tests used to diagnose vitamin B12 deficiency, the distribution of test results, and the subsequent secondary tests and treatments that are offered to patients. We will also test the feasibility of encoding and measuring the symptoms of B12 deficiency in CPRD, and estimate the prevalence of symptoms reported in annual periods before and after treatment initiation. Our target population is the general population of England and Wales who undergo B12 testing, in particular those with vitamin B12 deficiency.
Vitamin B12 deficiency is common and causes fatigue, pain and neurological symptoms. It is diagnosed by a blood test (measuring the concentration of either 'active' or 'total' B12 in serum) (1). Deficiency can be caused by lack of B12 in diet or by different pathologies that limit its uptake.
We will use anonymised test, treatment and clinical data from CPRD Aurum, linked with ethnicity and social deprivation indices to describe the patterns of findings of vitamin B12 test results between 2014 and 2024. We will describe the results quantitatively and qualitatively owing to variation in diagnostic thresholds.
Using a subset of patients, weighted toward the most deficient we will describe the secondary tests used to diagnosis pernicious anaemia, and compare ongoing treatments (prescribed oral supplements vs injections) with test results. Variation across practices and by patient age, sex, ethnicity and social deprivation will be described.
Many patients continue to suffer symptoms despite regular B12 injections, and although treatment satisfaction may be poorly recorded we will develop codes for common symptoms and measure the annual prevalence of reported symptoms over time before and after treatment initiation.
Hence we will describe recent practice and potential inequalities with respect to diagnosing and managing B12 deficiency, which may inform strategies to benefit public health.
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The incidence of diuretic associated sequential prescribing cascades: a feasibility study — Daniala Weir ...
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The incidence of diuretic associated sequential prescribing cascades: a feasibility study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Daniala Weir - Chief Investigator - Utrecht University
Daniala Weir - Corresponding Applicant - Utrecht University
Fatma Karapinar - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Johannes Nielen - Collaborator - Maastricht University Medical Centre
Kirsten Duijts - Collaborator - Utrecht University
Kjell van der Walle - Collaborator - Maastricht University Medical CentreOutcomes:
First time use of secondary marker medication including antigout medications, medications for urinary frequency and incontinence, potassium salts (incl. combinations) and potassium sparing agents (incl. combinations).
Description: Lay Summary
A prescribing cascade occurs when adverse drug reactions (ADRs) of one medication (index medication) are interpreted as individual complaints that are subsequently treated with another medication (marker medication). Prescribing cascades can have serious consequences as they contribute to polypharmacy (using multiple drugs) and can result in the use of unnecessary and preventable medications, more referrals to healthcare providers and a reduced quality of life. A lack of knowledge and awareness about ADRs and prescribing cascades for example contributes to the occurrence of prescribing cascades.
Technical Summary
Most of the literature on prescribing cascades focusses on individual prescribing cascades and therefore, little is known about consecutive prescribing cascades, when an ADR of a marker drug is treated with a third drug. Increasing the knowledge and awareness on consecutive prescribing cascades will contribute to better detection of preventable medication use.
This study will look at how many patients that started an index medication and were prescribed a diuretic within one year to treat peripheral oedema, a known side effect of the index medication, also were prescribed a second marker medication a year after the first prescription of the diuretic. This will help to understand to which extent analyses are possible for further research on consecutive prescribing cascades. This feasibility study thus represents a first step towards further research aimed to enhance healthcare providerâs awareness and understanding of prescribing cascades, potentially laying the groundwork for developing practical strategies to recognize, prevent, and mitigate consecutive prescribing cascades in clinical practice.Aim/Objective
An index drug is the initial drug that is started and causes a side effect, if this side effect is interpreted as a new condition, this may lead to the prescription of an additional drug (marker drug). The aim of this feasibility study is to determine how many patients in clinical practice experience a consecutive prescribing cascade involving diuretics. This will help to understand to which extent analyses are possible for further research on consecutive prescribing cascades using CPRD Aurum. Ultimately, this can enhance healthcare providerâs awareness and understanding of prescribing cascades, potentially laying the groundwork for developing practical strategies to recognize, prevent, and mitigate consecutive prescribing cascades.Design/method
For this, retrospective cohort study diuretics are selected as the medication class involved in prescribing cascades as both index and marker medications. Calcium channel blockers and gabapentinoids are selected as preceding index medications. Antigout medications, medications for urinary frequency and incontinence, potassium salts and potassium sparing agents were selected as secondary marker medications. Patients aged 65 and older who are newly prescribed a index medication between 2018-2023 and within a year after starting, are also newly prescribed a diuretic are included. Within this group it will be studied whether the patients are newly prescribed a secondary marker medication within one year.Analysis
Demographic characteristics of included patients will be summarized as frequency (%) for the categorical variables and mean ± SD for continuous variables with normal distribution or median in case of a non-normal distribution. From the included patients, incidence will be calculated of patients receiving a secondary marker, for each class of medication as stated under outcomes. It will also be explored whether there are any indications recorded at the time of prescription of the diuretic.Incidence stratified by demographic (e.g. age and sex) will also be reported.
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Feasibility study to assess polypharmacy and associated health outcomes using Clinical Practice Research Datalink data in older adults receiving home care in England — Adam Todd ...
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Feasibility study to assess polypharmacy and associated health outcomes using Clinical Practice Research Datalink data in older adults receiving home care in England
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Adam Todd - Chief Investigator - Newcastle University
Radin Karimi - Corresponding Applicant - Newcastle University
Anna Robinson-Barella - Collaborator - Newcastle University
Barbara Hanratty - Collaborator - Newcastle University
David Sinclair - Collaborator - Newcastle UniversityOutcomes:
Primary Outcomes: Prevalence of polypharmacy; Changes in prescribing patterns before and after admission to care homes.
Secondary Outcomes: Common medication types and combinations; Adverse drug reactions (ADRs); Mortality; Hospitalisation; Impact of socio-economic deprivation on polypharmacy, hospitalisations, and ADRs.
Description: Lay Summary
This feasibility study will assess the feasibility of studying polypharmacy and associated health outcomes in older adults receiving home care services in the United Kingdom (UK). Polypharmacy, defined as the use of five or more medications simultaneously, is common among older adults with multiple health conditions. While necessary in some cases, polypharmacy increases the risk of harmful side effects, medication errors, and complications that can lead to hospitalisations or reduced quality of life.
We will use anonymised healthcare records from the Clinical Practice Research Datalink (CPRD) to evaluate whether the data can support research on polypharmacy in individuals receiving (paid-for) care at home â services known as home care or domiciliary care. We will assess the extent of polypharmacy, explore which medications are commonly prescribed together, and examine how prescribing patterns change when individuals move from home care to care homes. We will also evaluate whether linked data, such as hospital records, can provide additional insights into outcomes like hospitalisations and adverse drug reactions.
The findings from this feasibility study will confirm whether CPRD data can adequately determine patterns in medication use and associated health risks in this population. This work will evaluate the potential to improve prescribing practices and medication management for older adults receiving home care services, ultimately informing healthcare providers and policymakers and supporting safer and more effective use of medications. By addressing these issues, the study aims to improve health outcomes and the overall quality of care for people receiving home care services.
Technical SummaryThis feasibility study aims to evaluate the potential to investigate polypharmacy and associated health outcomes in older adults (aged 65 and over) receiving home care in England. Using data from the Clinical Practice Research Datalink (CPRD) Aurum, linked with Hospital Episode Statistics Admitted Patient Care (HES APC) and the Index of Multiple Deprivation (IMD), the study will assess data completeness, linkage feasibility, and availability of exposures, outcomes, and covariates.
Polypharmacy, defined as the concurrent use of five or more medications, is the primary exposure of interest. This study will examine whether CPRD data can reliably capture polypharmacy prevalence, prescribing patterns, and associated outcomes such as adverse drug reactions (ADRs), hospitalisation, and mortality (using the death date recorded in CPRD) in individuals receiving home care services. The ability to track transitions between home care and care homes will also be evaluated. Linked HES APC data will support analysis of hospitalisation events, while IMD data will enable stratification of outcomes by socio-economic status. HES APC discharge data cross-validated with CPRD refines home care classification. Data availability will be assessed for key variables, including medication prescribing, ADRs, hospitalisations, mortality, and care transitions. Descriptive statistics will examine baseline characteristics, polypharmacy prevalence, and common medication combinations, while feasibility counts will estimate the cohort size. Established code lists for exposures and outcomes (e.g., ADRs and transitions) will be used where possible. Governance measures, including adherence to CPRDâs small-cell policy and data protection guidelines, will ensure privacy and confidentiality throughout.
Findings from this feasibility study will determine whether CPRD data can support future research aimed at optimising medication use and reducing risks for older adults in the home care setting. By preparing for future research, this study supports public health efforts to enhance the quality and safety of care for older adults receiving home care services.
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Diagnosis and Treatment of Vasomotor Symptoms in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy in England: A Descriptive Observational Cohort Study — Amy Storfer...
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Diagnosis and Treatment of Vasomotor Symptoms in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy in England: A Descriptive Observational Cohort Study
Datasets:GP data, HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-21
Organisations:
Amy Storfer-Isser - Chief Investigator - Astellas US LLC
Amy Storfer-Isser - Corresponding Applicant - Astellas US LLC
David Oliveri - Collaborator - Astellas Pharma Global Development, Inc.
Robert Snijder - Collaborator - Astellas Pharma Europe Ltd.
Ting-An Tai - Collaborator - Astellas Pharma Co Ltd, IrelandOutcomes:
Outcomes whilst receiving AET in primary care:
⢠Proportion diagnosed with VMS (primary outcome)
⢠Proportion prescribed VMS treatment (hormonal and non-hormonal medications) in primary care
⢠Number general practitioner and specialist outpatient visits: all-cause and menopause-related
⢠AET type (tamoxifen or aromatase inhibitors)
⢠AET durationOutcomes at date of first AET in primary care (index date)
⢠Sociodemographic characteristics (e.g., age; ethnicity; body mass index; current smoker)Outcomes prior to AET in primary care:
⢠Clinical characteristics (e.g., age at BC diagnosis; time from BC diagnosis to AET; comorbidities; surgeries)
⢠Proportion diagnosed with VMS or menopauseDescription: Lay Summary
Some women with breast cancer have receptors to hormones such as oestrogen and progesterone in their breast cancer cells, known as hormone receptor positive (HR+) breast cancer. Adjuvant endocrine therapy (AET) may be prescribed to women with HR+ breast cancer. Side effects of adjuvant endocrine therapy include hot flushes and night sweats, known as vasomotor symptoms (VMS). These can disrupt a womanâs life, well-being and may stop them from continuing with treatment.
This study is about women being treated with adjuvant endocrine therapy for HR+ breast cancer that has not spread to other parts of the body. The main aim of this study is to learn how many women have hot flushes/night sweats whilst receiving this therapy. Other aims are to learn about management of hot flushes/night sweats by general practitioners; to summarize the number outpatient visits with general practitioners and specialists during the first year of treatment; describe the number of months of adjuvant endocrine therapy treatment; and describe characteristics of these women such as average age at breast cancer diagnosis. This study will use existing deidentified data from 2011-2023 from primary care practices and outpatient hospital visits that is available for research purposes.
The results of this research will provide information on the proportion of women who experience VMS whilst receiving AET for breast cancer and the medications that were prescribed to manage the symptoms. This will ultimately raise awareness of this condition and may improve the treatments of VMS.
Technical SummaryAdjuvant endocrine therapy (AET) is a treatment intended to reduce the risk of breast cancer (BC) recurrence. A Common side effects of AET are hot flushes and night sweats, also known as vasomotor symptoms (VMS). VMS can adversely affect a patientsâ quality of life, outpatient healthcare utilization and compliance with AET. Evidence is lacking on the diagnosis and management of VMS among women receiving AET for BC in England.
The main aim of this descriptive observational cohort study is to describe the proportion of women diagnosed with VMS whilst receiving AET for BC. Other study aims are to describe the management of VMS in primary care (prescriptions for hormonal and non-hormonal [e.g., serotonin reuptake inhibitors [SSRIs]) therapies); to describe outpatient healthcare utilization during the first year of AET treatment; and to describe the clinical and sociodemographic characteristics of women with BC prior to receiving AET.
The eligibility criteria are:
1. Adult (aged ⥠18 years) females with â¥1 AET prescription (tamoxifen or aromatase inhibitors) written in primary care
2. BC diagnosis prior to the first AET
3. No diagnosis of metastatic cancer prior to the first AET
4. No diagnosis of malignancy other than BC or skin cancer during the 12 months prior to the first AETWe will use CPRD Aurum to create the study population and for all study aims. We will use both CPRD Aurum and Hospital Episode Statistics Outpatient (HES OP) data to describe the proportion of study population diagnosed with VMS and to describe outpatient healthcare utilization by care setting (general practitioner or specialist). Results will be summarized using univariate descriptive statistics.
The findings of this study will enhance the understanding of the burden and management of VMS in women undergoing AET for breast cancer, ultimately improving patient care and quality of life.
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Predicting gastrointestinal disease following faecal calprotectin testing in primary care: a feasibility study — Leo Alexandre ...
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Predicting gastrointestinal disease following faecal calprotectin testing in primary care: a feasibility study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-14
Organisations:
Leo Alexandre - Chief Investigator - University of East Anglia
Leo Alexandre - Corresponding Applicant - University of East Anglia
Allan Clark - Collaborator - University of East Anglia
Jithu Kozhimannil Jose - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Simon Chan - Collaborator - Norfolk and Norwich University HospitalsOutcomes:
Inflammatory bowel disease diagnoses within 1, 3 and 5 years of a measured faecal calprotectin including Crohn's disease; ulcerative colitis; microscopic colitis and the terms that are used to describe these diseases and location e.g. ileitis; colitis; proctitis.
Description: Lay Summary
Chronic abdominal pain with a change in bowel habits accounts for >10% of presentations to general practice. These symptoms are non-specific, meaning they do not help clinicians distinguish between patients with colorectal cancer, inflammatory bowel disease (IBD) or benign bowel disorders such as irritable bowel syndrome.
The National Institute for Health and Care Excellence (NICE) guidance recommends the use of faecal calprotectin (FC), a stool test for bowel inflammation, to aid general practitioners when considering the need for specialist assessment of suspected IBD when cancer is not suspected. Evidence supporting these recommendations is very limited and is unlikely to be directly relevant to primary care. Importantly, âthresholdâ FC values triggering the need for specialist assessment are not defined, a point acknowledged in current guidance and research. NICE further suggest repeat FC testing to aid diagnosis in patients with an intermediate range of FC values above the reference range. There is no evidence to support this. Unfortunately, using the upper limit of the FC ânormal rangeâ as the threshold for specialist assessment will result in a large number of unnecessary referrals/procedures for non-IBD conditions. This study will investigate the feasibility of developing a risk prediction tool for IBD for patients who have had their FC assessed. We will calculate the number of patients with FC measurements who could contribute to this future research (grouped according to age and sex), the numbers who develop IBD in each group and the availability of information which could contribute to a risk prediction tool.
Technical SummaryWe aim to use the CPRD to explore the feasibility of developing a risk prediction model for inflammatory bowel diseases (IBD) in patients who have had faecal calprotectin (FC) assessments in primary care. The future risk prediction tool, subject to performance, could be used in the future to help clinicians and patients consider the pre-test probability of IBD and determine the urgency and need for onward gastrointestinal investigations. All analyses will be descriptive using counts and percentages, mean (standard deviation) or median (interquartile range). We will not report counts <5.
Objectives are:
1. Determine the number of eligible patients (per annum) with and without gastrointestinal symptoms and a measured FC.
2. Determine the overall range of FC measurement values and the number of patients with repeat FC measurements and concurrent (Faecal Immunochemical Test) FIT testing.
3. Determine the number and proportion of eligible patients contributing to CPRD from 2012 to present diagnosed with IBD (including type of IBD) and site affected within 1, 3 and 5 years of a measured faecal calprotectin, stratifying by sex, age, indices of multiple deprivation (IMD) and FC levels (denominator all patients with measured FC and no previous IBD).
4. For each stratum present the number of patients with a FC measurement and determine the distribution of values.
5. For broader strata (sex and age) determine the number and proportion with variables expected to contribute to a multivariable prediction tool for IBD in patients with and without FC measurements.
6. Describe whether we can match eligible patients with and without gastrointestinal symptoms and an elevated FC to 1) asymptomatic controls with an unraised, elevated or unknown FC status; 2) symptomatic controls with an unraised, elevated or unknown FC status. Matching criteria will include age, sex, GP practice, and alive and under follow-up at index date.
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Describing prescribing of opioid medications in the UK: a feasibility study — Helen Booth ...
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Describing prescribing of opioid medications in the UK: a feasibility study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-17
Organisations:
Helen Booth - Chief Investigator - MHRA
Helen Booth - Corresponding Applicant - MHRA
Craig Allen - Collaborator - MHRA
Rachael Williams - Collaborator - CPRDOutcomes:
Opioid prescriptions.
We will use summary statistics (counts, percentages) to describe the type, strength, dose and route of administration. This information will be stratified by year.
We will describe the study population in terms of sex and age. We will describe the number of opioid types and the duration of treatment at a patient level.
Description: Lay Summary
Opioid medications are used to treat pain but carry the risk of dependence and addiction in patients using them. Concerns over high rates of opioid prescribing in the UK led the Medicines and Healthcare products Regulatory Agency (MHRA) to publish safety alerts about these risks in 2020. The aim of this study is to describe prescriptions for opioid medications in UK primary care, including the type, dose, length of treatment and route of administration (e.g. pills, patches), over the period 2017 to 2024. Currently, the completeness and level of detail available on these variables in the data in not known. This work will support the development of a more detailed future study on trends in prescribing of opioid medications. The results of the further study will help us to understand whether further measures are needed to support safe prescribing of these drugs in the UK.
Technical SummaryIn 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published drug safety alerts to support safer prescribing of opioid medications. This advice was issued due to concerns over the risk of dependence and addiction in non-cancer patients treated with opioids long-term, following a review by Public Health England (PHE). The MHRA committed to monitoring the impact of the risk minimisation measures and are exploring the best way to approach this given a wider suite of campaigns across the health service to reduce opioid prescribing. A future study will assess trends in opioid prescribing, but in addition we will be interested in the types, strengths, dosages, routes and length of prescribing for these drugs. The detail available on some of these characteristics in CPRD GOLD and Aurum are not well understood. This feasibility study will describe opioids prescribed in the CPRD primary care databases over the period 2017 to 2024, to better understand what data is available for a larger study on prescribing trends of opioids. All prescriptions of opioids in the period will be included, and we will present counts and summary statistics by opioid type. Results of an onward study would be used to determine the need for further regulatory action to support safe prescribing of opioids in the UK.
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Development and validation of fracture risk prediction model for people experiencing cancer — Darren Ashcroft ...
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Development and validation of fracture risk prediction model for people experiencing cancer
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-08
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Thamer Ba Dhafari - Corresponding Applicant - University of Manchester
Bo Abrahamsen - Collaborator - University Of Southern Denmark
Claire Higham - Collaborator - The Christie NHS Foundation Trust
Glen Martin - Collaborator - University of ManchesterOutcomes:
The primary outcome is any Major Osteoporotic Fractures (MOF): at the hip, forearm, vertebra/spine, and shoulder/upper arm after cancer diagnosis. The secondary outcome is all fractures, including both MOF sites and all malignant pathological fractures. This will cover fractures related to metastasis or primary bone/bone marrow cancer, capturing the full spectrum of fracture burden.
Description: Lay Summary
As more people are living longer after cancer, many of them face a higher risk of broken bones. This risk can come from the cancer itself, lifestyle factors like smoking, or treatments that weaken bones. Broken bones can cause pain, reduce mobility, and in the worst cases, contribute to death. Yet, most of those patients with cancer do not get regular checks or treatment for bone health.
Technical Summary
Our study will explore ways to improve fracture risk assessments for people with cancer. We aim to create models that can help predict which patients may have a higher chance of fractures. These models will support healthcare practitioners in deciding who might need extra treatments or more frequent monitoring.
To build these models, we will analyse health records of people who experience cancer, focusing on factors such as age, cancer type, and treatments received. By studying how these factors relate to bone health, we plan to give healthcare practitioners and patients an approach to predict fracture risk and plan care. This research will help with current gaps in bone health care for people who have experienced cancer.Recent improvements in cancer survival have led to a growing population of patients who face increased fracture risks from both the disease and its treatments. While fracture risk prediction tools exist for the general population (FRAX, Q-Fracture), they have not been extensively validated in patients with cancer who may have unique risk factors. Recent evidence from large population studies shows increased fracture risks in 15-17 of 20 common cancers, with risks remaining elevated for over 5 years in several cancer types.
Using the UK Clinical Practice Research Datalink (CPRD) Aurum and GOLD databases databases linked to hospital, cancer registry and mortality data, we will develop and validate prediction models for fracture risk in people who experience cancer. The study will use statistical modelling including time-dependent Cox regression and survival analysis to predict major osteoporotic fractures and any bone fractures. We will compare performance with existing tools like FRAX and Q-Fracture in cancer populations, validate models internally within CPRD Aurum and externally in CPRD GOLD using an internal-external cross-validation approach. Model performance will be assessed using discrimination, calibration and clinical utility metrics, with particular attention to potential inequalities in risk prediction. This work will help inform evidence-based fracture prevention strategies.
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Predicting rheumatoid arthritis risk using electronic healthcare records: the RheumDetect study — Garth Funston ...
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Predicting rheumatoid arthritis risk using electronic healthcare records: the RheumDetect study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Garth Funston - Chief Investigator - Queen Mary University of London
Baoyue Zhang - Corresponding Applicant - Queen Mary University of London
Mark Russell - Collaborator - King's College London (KCL)
Oleg Blyuss - Collaborator - Barts and the London Queen Mary's School of Medicine and DentistryOutcomes:
The primary clinical outcome is a diagnosis of Rheumatoid arthritis (RA), as recorded in Clinical Practice Research Datalink (CPRD)/Hospital Episodic Statistics (HES) data.
Description: Lay Summary
Around 1% of people in the UK suffer from Rheumatoid arthritis (RA), a condition in which the bodyâs immune system attacks joints and other tissues. It can lead to permanent disability and have a significant impact on quality of life. Picking RA up as early as possible is important, as it means patients can start treatment promptly. This can prevent joint damage, and improve patientsâ outcomes.
For many serious health conditions, patients can experience symptoms, visit doctors more, and have changes in blood test results and the prescriptions they receive, months or even years before âred flagâ symptoms are reported and a diagnosis is made. Such changes in clinical events could help alert doctors to the possibility of RA, support earlier diagnosis and improve patient care.
In this study, we will use anonymized General Practice (GP), hospital, and socioeconomic data from UK patients. Firstly, we will examine how patterns in clinical activity, e.g. blood tests and prescriptions, change in the lead up to RA diagnosis. Secondly, we will determine the probability of patients having RA based on combinations of this information, e.g. different symptoms and blood test results. Lastly, we will develop an Artificial Intelligence (AI) based model incorporating this information to predict which patients will be diagnosed with RA. This research has the potential for public benefit as the knowledge of the probability of RA based on different clinical features and the development of an accurate AI based prediction model could aid more timely RA detection in primary care.
Technical SummaryRA can lead to permanent disability and comorbidities, particularly in the context of delayed diagnosis. However, early diagnosis and treatment with disease-modifying drugs have been shown to improve outcomes and prevent morbidity. Recent studies show that patients present to GP more frequently in the two years before RA diagnosis, indicating that a prolonged âdiagnostic windowâ may exist in which more timely detection could be achieved for some patients. Advances in machine learning (ML) methods mean that temporal patterns in clinical events recorded within healthcare records, like symptomatic presentations and blood tests, can be used to predict diagnosis of serious health conditions.
In this study, we will use Aurum and GOLD data from the Clinical Practice Research Datalink (CPRD), linked to small area level and Hospital Episodic Statistics (HES) Inpatient and Outpatient data. Firstly, we will perform a nested case-control study examining temporal patterns of clinical events (including symptoms, blood test results, prescriptions, co-morbidities) occurring up to 5 years before RA diagnosis. Different statistical approaches, including conditional logistic regression and joinpoint regression will be employed. Secondly, we will perform a cohort study to calculate the positive predictive value(PPV) of combinations of clinical features for RA in primary care. Thirdly, we will use conventional regression (multivariable logistic regression) and ML-based approaches (including Natural Language Processing techniques) to develop diagnostic prediction models for RA which take account of temporal patterns in patient records. Models will be developed using Aurum data and externally validated in GOLD. Measures of model discrimination and calibration for RA diagnosis within defined periods (6, 12, 18, 24 months) will be calculated and accuracy at a range of risk thresholds determined. If models perform well, they could be used in primary care setting to select appropriate patients for RA investigations, benefiting patients and the public through earlier detection of RA.
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Large weight loss and risk of developing micro- and macrovascular disease in adults living with both obesity and type 2 diabetes: a cohort study — Jessica Bengtsson ...
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Large weight loss and risk of developing micro- and macrovascular disease in adults living with both obesity and type 2 diabetes: a cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Jessica Bengtsson - Chief Investigator - Novo Nordisk A/S
Jessica Bengtsson - Corresponding Applicant - Novo Nordisk A/S
Anders Boeck Jensen - Collaborator - Novo Nordisk A/S
Claire Miller - Collaborator - Novo Nordisk A/S
Eva Johnsen - Collaborator - Novo Nordisk A/S
Peter Nørgaard Kristensen - Collaborator - Novo Nordisk A/S
Rie Wasehuus - Collaborator - Novo Nordisk A/SOutcomes:
Microvascular disease, including:
⢠retinopathy
⢠neuropathy
⢠chronic kidney diseaseMacrovascular disease, including:
⢠myocardial infarction
⢠peripheral artery disease
⢠strokeDescription: Lay Summary
Type 2 diabetes (T2D) is a disease that leads to difficulties in controlling blood sugar levels. Over time, high blood sugar levels may cause serious damage to the heart, blood vessels, eyes, kidneys, and nerves. This risk is especially high in people with T2D who are also living with obesity. Therefore, weight loss is an important strategy to reduce this risk. Studies have shown that a modest weight loss of 5-10% can lower the risk of heart disease in people living with T2D and obesity, but few studies have investigated the health benefits of losing more weight.
In this study, we will investigate whether people newly diagnosed with T2D who are living with obesity can lower their risk of serious health conditions by losing at least 20% of their body weight. We will specifically focus on health conditions related to small blood vessels, such as kidney disease and eye damage, and health conditions related to large blood vessels, such as heart attack and stroke. We will compare the risk of developing these conditions among people who lose at least 20% of their body weight to those who do not lose weight.
The findings of this study may inform patients and health care professionals about the importance of initiating lifestyle changes or other weight loss treatments to lower the risk of serious health conditions in people newly diagnosed with T2D who are living with obesity.
Technical SummaryThe objective of this study is to investigate potential micro- and macrovascular benefits of large weight loss in adults newly diagnosed with type 2 diabetes (T2D) who are living with obesity. We specifically aim to estimate the association between â¥20% weight loss and development of microvascular (retinopathy, neuropathy, chronic kidney disease) and macrovascular (myocardial infarction, peripheral artery disease, stroke) disease, respectively.
We will include adults (â¥18 years) living with obesity (body mass index [BMI] â¥30 kg/m2) who are diagnosed with T2D from January 2000 onwards. Exclusion criteria include prevalent micro- or macrovascular disease, pregnancy, limb amputation, and conditions that may indicate unintentional weight loss (e.g., cancer, thyroid disorder, human immunodeficiency virus). Diseases will be determined using primary care, outpatient, and hospital data, combined with records of causes of death. Linkage to ethnicity and deprivation records will enable important confounding control. Individuals with â¥20% weight loss over a baseline period following T2D diagnosis will be matched 1:4 to individuals maintaining a stable weight (
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Glucocorticoid use and initiation of Selective Serotonin Reuptake Inhibitors among patients with rheumatoid arthritis: a nested case-control study in CPRD Aurum — Patrick Souverein ...
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Glucocorticoid use and initiation of Selective Serotonin Reuptake Inhibitors among patients with rheumatoid arthritis: a nested case-control study in CPRD Aurum
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Eibert Heerdink - Collaborator - University Medical Centre Utrecht
Elisabeth Bijlsma - Collaborator - Utrecht Institute for Pharmaceutical Sciences
Elise Heesbeen - Collaborator - Utrecht Institute for Pharmaceutical Sciences
Katharina Jovic - Collaborator - Utrecht University
Lucianne Groenink - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes:
Initiation of SSRI treatment
Description: Lay Summary
Mental health disorders, such as anxiety disorders, are affecting many people worldwide and this number has been steadily increasing these last years. However, it is not completely understood what causes the development of anxiety disorders. There is evidence that points towards involvement of the immune system there is still a lot of missing information regarding this possible link. Currently, the first choice of treatment for patients with an anxiety disorder are a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). This class of antidepressant medication is known to alter the levels of a specific chemical in the brain, thereby reducing anxiety symptoms. We want to assess whether patients with a reduced activity of their immune system (due to glucocorticoids - a class of medications that reduce inflammation in your body) are less or more likely to start with SSRIs, indicating a change in their anxiety symptoms. We will conduct this study within patients with rheumatoid arthritis, as one of the standard treatments for these patients are glucocorticoids. Rheumatoid arthritis is a disease where the immune system (which usually fights infection) attacks the cells that line your joints by mistake, making the joints swollen, stiff and painful. Over time, this can damage the joints, cartilage and nearby bone. Resutls from this study can give us more insight in the role of the immune system in the development of anxiety disorders, which can benefit patients in the future.
Technical SummaryGlucocorticoids (GCs) are steroid hormones with widespread effects including potent immune-suppressive and anti-inflammatory effects particularly when administered pharmacologically. In this study, we aim to investigate whether the immune system plays a role in the development of anxiety disorders, determined by the initiation of SSRI treatment. The study will be nested within a cohort of subjects with a diagnosis of rheumatoid arthritis as these patients are frequently treated with glucocorticoids. Cases are patients with a first prescription for an SSRI after being diagnosed with RA. Controls will be matched 1:4 to each case based on sex, year of birth, duration RA (+/- 2 years) and practice.
The association between glucocorticoid use and the initiation of an SSRI will be assessed by conditional logistic regression analysis to calculate odds ratios (OR) and 95% confidence intervals (95%CI). Glucocorticoid exposure will be refined by assessing the effect of cumulative dose, duration of use, type and dosage form.
Results from this study could provide some new insights regarding the role of the immune system in the development of anxiety disorders.
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Investigating changes in general practitioner admission patterns following introduction of emergency admission risk stratification tools, a natural experiment using linked routine data. — Alan Watkins ...
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Investigating changes in general practitioner admission patterns following introduction of emergency admission risk stratification tools, a natural experiment using linked routine data.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CCG Pseudonyms
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Alan Watkins - Chief Investigator - Swansea University
Mark Kingston - Corresponding Applicant - Swansea UniversityOutcomes:
Primary outcome
Case mix severity of admissions, operationalised as proportion of high versus low risk admitted patients using a combination of GP urgency ratings, GP medical condition codes, HES: Diagnoses, treatments and investigations.
Key secondary outcomes:
All cause hospitalisations; All cause mortality;
Emergency admissions to A+E or Admitted patient careDescription: Lay Summary
In recent years, there has been an increase in the number of people urgently admitted to hospitals in the UK, despite efforts to implement policies aimed at reducing emergency admissions. Emergency hospital admissions can have negative impacts on individuals' health and independence and they also strain the National Health Service (NHS) due to challenges in quickly and safely discharging patients to their homes.
Technical Summary
To address this issue, many general practitioner (GP) practices have adopted computer tools called Emergency Admission Risk Stratification (EARS) tools. These tools predict each patient's likelihood of being admitted to the hospital within the next year. The intended purpose is for GPs to focus care on those individuals who are at a higher risk, providing support at home to prevent hospitalisation.
The objective of this research project is to evaluate whether the implementation of prediction tools has influenced GPs' decisions to admit patients to the hospital. The study will analyse anonymised patient data from GP practices that adopted EARS tools in 2014 and compare it with data from practices that did not use these tools.
Anticipated benefits for public health include gaining insights into how EARS tools have impacted emergency admissions. Understanding whether GPs' decision-making processes have changed with the introduction of these tools could facilitate the development of improved guidelines and best practices for the effective use of EARS tools in the future.Emergency hospital admissions have increased across the UK. A prominent policy-led initiative has seen the introduction of emergency admission risk stratification (EARS) tools in primary care. These use algorithmic models and routine patient data to generate risk scores reflecting patientsâ likelihood of emergency admission. By identifying high-risk individuals, EARS tools aim to enable targeting of services to avoid admissions. However, evidence on EARS impacts on clinician behaviours and admission trends is lacking.
This study will utilise individual and practice-level data from CPRD linked to Hospital Episode Statistics to examine EARS effects on GP admission thresholds and case severity mix. We will include CPRD contributing practices in English CCGs where EARS use was approved in May-June 2014 and seek data on patient emergency hospital admissions for two years either side. Additionally, we will request data for control practices where EARS was approved after June 2016 or not at all.
We aim to provide evidence on how EARS influenced clinical decision-making, using a natural experiment design. We will compare patient admission profiles in intervention and control cohorts to isolate the effects of EARS tools from secular emergency admission trends and account for regression to the mean. Causal effects of EARS tools on thresholds and case-mix will be evaluated by comparing trends in intervention and control cohorts over an interrupted time series.
We will assess emergency admission rates and case severity before and after EARS rollout. Multivariable logistic regression will quantify differences in GP admission of low- versus high-risk patients, adjusting for demographics, comorbidities, and other confounders. Severity will be classified using indicators such as acute versus chronic presentation and urgency ratings.
EARS tools are supported in NHS policy. It is important to understand how they affect decision-making and impact the NHS. Our findings will provide insights to guide optimal use.
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Examining patterns and health inequalities of clusters of multiple long-term conditions in England — Rosa Parisi ...
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Examining patterns and health inequalities of clusters of multiple long-term conditions in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Rosa Parisi - Chief Investigator - University of Manchester
Rosa Parisi - Corresponding Applicant - University of Manchester
Chris Kypridemos - Collaborator - University of Liverpool
Evangelos Kontopantelis - Collaborator - University of Manchester
Laura Anselmi - Collaborator - University of Manchester
Luke Munford - Collaborator - University of Manchester
Mamas Mamas - Collaborator - Keele University
Martin Rutter - Collaborator - University of Manchester
Rupert Payne - Collaborator - University of ExeterOutcomes:
Aim 1
a)/b) Prevalence of twenty âmultimorbidity clustersâ such as:
⢠psychoactive substance and alcohol misuse;
⢠coronary heart disease, depression and pain;
⢠coronary heart disease, heart failure and atrial fibrillation.Aim 2
c) Incidence, prevalence and case fatality of 38 individual conditions used to build all âmultimorbidity clustersâ.d) Incidence, timing and onset of individual conditions within each âmultimorbidity clusterâ. Incidence of each âmultimorbidity clusterâ and time between first condition and âmultimorbidity clusterâ.
Aim 3
Prevalence of risk factors within each âmultimorbidity clustersâ.Aim 4
Healthcare use (hospitalisation for any cause; GP visits) and mortality (any cause).Description: Lay Summary
âMultiple long-term conditionsâ or multimorbidity is used to describe people living with two or more conditions for a long time, e.g. heart disease and high blood sugar level. People with multiple long-term conditions tend to visit their general practitioner (GP) and use hospitals two to three times more often than people with one or no conditions.
Certain groups of long-term diseases occur together more often than others â these are known as âmultiple long-term condition clustersâ. However, we donât know much about how many people have these groups of conditions in different areas of England or by certain characteristics such as age, sex, social deprivation and ethnicity.We will use anonymous data from general practice in England, between 2006-2020, to understand how many people currently live with groups of chronic conditions that often occur together across England and by age, sex, ethnicity, and how deprived or wealthy they are, whether they live in rural areas or if they are migrant. We will also explore how these conditions progress during the life of individuals and what the risk factors within these groups of conditions are and how often people living with specific âmultiple long-term condition clustersâ are hospitalised or die.
This information will be valuable to researchers and policymakers to tackle health inequalities.
Technical SummaryBackground
Multimorbidity is when people have two or more long-term conditions. Due to aging population, multimorbidity is a huge challenge to patients and health services. Certain conditions are more likely to co-exist than others, these are called âmultimorbidity clustersâ. There is limited knowledge about current and future disease and healthcare burden of âmultimorbidity clustersâ across England and their distribution by socio-demographic factors.
Aim and objectives
The study aims to quantify the disease burden of common âmultimorbidity clustersâ in England and their association with healthcare use. In particular, we plan to:1. Quantify current prevalence of âmultimorbidity clustersâ in and across regions of England and by socio-demographic factors.
2. Estimate trends during the life-course of common âmultimorbidity clustersâ in England and by socio-demographic factors.
3. Describe the frequency of common risk factors within each âmultimorbidity clustersâ.
4. Quantify healthcare use associated with common âmultimorbidity clustersâ.
Methods
A cohort of people with multiple chronic conditions from primary care (2006-2020) will be the study population of interest. We will use: Poisson regression models to estimate prevalence of âmultimorbidity clustersâ by socio-demographics characteristics in and across England; survival models to estimate incidence and trajectory of each âmultimorbidity clusterâ during the life course; linked hospital and mortality records and Poisson regression to estimate the association of each âmultimorbidity clusterâ with healthcare burden.By combining information from the literature and the estimates from the above objectives, we will inform a simulation model which will be used to project future prevalence and healthcare burden of âmultimorbidity clusterâ, and explore health interventions to target health inequalities and multimorbidity.
Impact and dissemination
Findings will provide a better understanding of the occurrence of common âmultimorbidity clustersâ to inform service reconfiguration and address health inequalities. Dissemination will occur via open access publications, conferences, and social media.
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Primary and Secondary Care utilisation after percutaneous & surgical cardiac intervention — Gianni D Angelini ...
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Primary and Secondary Care utilisation after percutaneous & surgical cardiac intervention
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-06
Organisations:
Gianni D Angelini - Chief Investigator - University of Bristol
Jeremy Chan - Corresponding Applicant - University of BristolOutcomes:
Primary outcome: incidence of hospital readmissions and causes of readmission.
Key secondary outcomes:
Socioeconomic, gender, and ethnicity disparities in readmission rates;
Long-term survival rates and their association with readmissions;
Frequency of GP visits post-surgery;
Time to first readmission or death;
Causes of death stratified by readmission status.
Feasibility of outcome ascertainment: Data on readmissions, mortality, and associated covariates will be derived from Hospital Episode Statistics (HES) and linked to socioeconomic data from the Index of Multiple Deprivation (IMD). GP visit records and clinical diagnoses will be extracted from the Clinical Practice Research Datalink (CPRD).Description: Lay Summary
Heart and lung surgeries are often needed to treat serious conditions like heart attacks and lung cancer, but recovery can sometimes be complicated. In the United States, research has shown that nearly one in four patients who have these surgeries need to go back to the hospital. However, there is very little information about how many patients need to see their general practitioner (GP) after surgery, especially in the United Kingdom(UK), where healthcare is provided through a universal health system rather than private insurance like in the United States.
Technical Summary
We want to find out how often patients in the UK need to visit their GP or return to the hospital after surgery for heart or lung conditions. More importantly, we want to understand why they need these services. By finding out the reasons of why patient visited their GPs or readmitted to hospital, we hope to find ways to reduce the demand on both GPs and hospitals, helping to improve patients' recovery and ease pressure on the healthcare system.This study aims to quantify healthcare utilisation after cardiothoracic surgeries, focusing on both primary care (e.g.GP visits) and secondary care (e.g. Hospital readmissions) in the UK. Specifically, we aim to estimate the proportion of patients requiring these services, identify predictors of utilisation, and explore the underlying reasons, with the ultimate goal of informing strategies to reduce healthcare demand. The study population includes adult patients undergoing cardiothoracic surgery, including but not limited to coronary artery bypass grafting and anatomical lung resection. Primary exposures include type of surgery, demographic factors (e.g., Age, Sex, Socioeconomic status), and comorbidities. The primary outcomes are GP visit frequency, hospital readmissions, and reasons for these interactions, categorised into clinical or logistical causes.
Data will be sourced from Hospital Episode Statistics (HES) Admitted Patient Care for hospital admissions and procedures, General Practice Data for Planning and Research (GPDPR) for GP visits, and socioeconomic information via the Index of Multiple Deprivation (IMD). Using a retrospective cohort design, descriptive statistics will summarise healthcare utilisation patterns, while multivariable regression models will identify predictors. Time-to-event analyses, including Kaplan-Meier curves and Cox proportional hazards models, will evaluate the timing of GP visits and hospital readmissions. Sensitivity analyses will address potential biases such as unmeasured confounding and missing data.
This research will have significant public health implications, providing a deeper understanding of the post-operative healthcare needs of patients undergoing heart and lung surgeries. By identifying key factors driving healthcare utilization, the findings can inform policy changes and care pathways aimed at improving recovery, reducing unnecessary healthcare visits, and easing pressure on both primary and secondary care services. This will ultimately contribute to better patient outcomes and more efficient use of resources in a universal healthcare system.
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Antibiotic prescribing for acute otitis media in children aged 17 years and younger in England: a retrospective cohort study — Catherine Hayes ...
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Antibiotic prescribing for acute otitis media in children aged 17 years and younger in England: a retrospective cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-09
Organisations:
Catherine Hayes - Chief Investigator - UK Health Security Agency (UKHSA)
Catherine Hayes - Corresponding Applicant - UK Health Security Agency (UKHSA)
Donna Lecky - Collaborator - UK Health Security Agency (UKHSA)
Harry Ahmed - Collaborator - Cardiff University
Julie Robotham - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
â¢Proportion of consultations for AOM relative to total number of consultations for age group in the included practices overall and annual.
â¢Proportion of AOM consultations that resulted in an oral antibiotic prescription (same day) relative to total number of AOM consultations, per month/year.
â¢Proportion of consultations that resulted in an oral or topical analgesic (non-antibiotic - pre-defined list) relative to total number of AOM consultations, per month/year.
â¢The proportion of types of antibiotic prescribed for AOM and whether these align with NICE guidance.
â¢Probability/odds of an antibiotic prescription for children with AOM by patient attributes (age, sex, deprivation, etc.).Description: Lay Summary
Using antibiotics can cause side effects and may lead to âantibiotic resistanceâ where the antibiotics will not work against the bacteria which cause an infection. Most antibiotics are used in the community and it is important to monitor and improve the use of antibiotics to try and reduce antibiotic resistance. Children often get earaches and parents will visit general practices (GPs) to see if the earache is caused by an infection. Ear infections are one of the most common reasons for children to be given antibiotics, however most children will get better without them. Recent research has shown that the public strongly believe that antibiotics are needed for most ear infections.
This descriptive study will describe how many children (aged 17 years and younger) in England visit their GP for middle ear infections and how many are given antibiotics. This research will include patients from general practices in England that gave anonymous data to the Clinical Practice Research Datalink from 2013 onwards. The main analysis will look at whether patients with certain characteristics (e.g. age, gender, deprived area) are more likely to have antibiotics than those without the characteristic. The project will provide up to date evidence on antibiotic prescribing for ear infections across the country. The findings will be used to help inform what could be done to improve the use of antibiotics for ear infections and highlight, if there are any differences in the types of patients prescribed antibiotics to inform further work needed in this area.
Technical SummaryAntimicrobial resistance (AMR) is a threat to public health. In England, 80% of antibiotics are prescribed in general practice and it is important to monitor prescribing of antibiotics in this setting for surveillance, and alignment with clinical guidance. Acute otitis media (AOM) is one of the most common indications for primary care consultations and antibiotic prescribing in children. Evidence from previous studies completed around 10 years ago using CPRD and similar databases found a high rate of antibiotic prescribing (85%) for AOM, despite national guidance recommending against antibiotics in most cases. Furthermore, public surveys conducted over recent years have suggests that the general public strongly believe that antibiotics are beneficial for majority of ear infections.
This study aims to describe trends in consultations and antibiotic prescribing for AOM in children 17 years of age and younger, from English general practices that contribute anonymised data to the Clinical Practice Research Datalink (CPRD), from 2013 onwards, where children presented with suspected AOM. Non-antibiotic treatments and attributes of patients who consult with these conditions, including their age, sex and other factors will also be described. The main statistical analysis will be a multi-level logistic regression model to explore associations between patient demographics and receipt of same-day antibiotic for an AOM consultation. This observational study will provide up to date evidence on national prescribing of AOM including the proportion of children prescribed antibiotics and whether patient attributes are associated with prescribing to explore any potential disparities in prescribing between groups. This will inform the need and design of interventions and what further work is needed to optimise primary care antibiotic prescribing for middle ear infections.
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Identifying and characterising groups of people with multiple long-term conditions _ multimorbidity: an analysis of observation data — Daniel Prieto...
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Identifying and characterising groups of people with multiple long-term conditions _ multimorbidity: an analysis of observation data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; CPRD GOLD Ethnicity Record; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Leena Elhussein - Corresponding Applicant - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Gianluca Fabiano - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Maria Sanchez - Collaborator - University of Oxford
Njoki Njuki - Collaborator - University of Oxford
Rafael Pinedo-Villanueva - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
For phases 1 and 2, the primary outcome will be one-year unplanned hospital admission.
For phase 3, the outcomes will be healthcare resource utilisation and associated costs to the healthcare system. Primary healthcare utilisation will encompass consultations with relevant healthcare professionals (i.e., GP, nurse, physiotherapist, etc.). Secondary healthcare utilisation will include admissions to Accident and Emergency (A&E), inpatient, and outpatient appointments. Description of resource utilisation will include the count of admissions, appointments, nature of the performed procedures, and duration of stays. Reimbursement costs of providing primary and secondary healthcare services will be estimated using PSSRU and NHS Reference unit costs.Description: Lay Summary
Why we are doing this: Many people are living with multiple diseases and long-term health conditions. Treatment options for these patients often treat the individual disease or health outcome, rather than treating them in combination for a more personalised approach. To plan a personalised approach for this group of patients, we need to know what the most common diseases and health conditions are that exist in combination, and the patient characteristics that are linked to increased use of health resources, including needing hospital care.
Technical Summary
What we will do: We will describe and understand patients living with multiple diseases and long-term health conditions and specifically characterise patients who are more likely to need hospital care and other healthcare support.
How we will do it: We will use existing information from general practitioner (GP) records that have been collected over time. We will first study patients aged 18 years or older and divide them into groups based on their combination of diseases and long-term health conditions. We will then describe the patients most likely to need hospital care and other healthcare support. Based on the findings, we will study changeable (like weight) and non-changeable (like age) patient characteristics that might be linked to increased use of health resources.
How this work will help: Results from this work will help national policy makers and healthcare providers to better treat their patients with multiple diseases and long-term health conditions in a more personalised way. In turn, patients can benefit from better health and well-being.The prevalence of people living with Multiple Long-Term Conditions often called âMultimorbidityâ (MLTC-M) is rapidly increasing. Current treatment guidelines often address conditions, acute symptoms and medication regimens, neglecting broader needs like mobility, functioning, social isolation, mental health, and well-being, leading to fragmentation of care. Access to joined up health, social care and voluntary support services is limited. This results in a high incidence of unplanned hospital admissions, lack of personalised attention and higher costs. In order to tailor personalised, holistic and cost-efficient treatment plans, we need to accurately specify the different combinations of MLTC-M that lead to the highest consumption of healthcare resources. Then, we need to characterise the patients with these combinations and describe the key risk factors associated with the increased risk of healthcare needs.
In this study, we will use primary and secondary care records for characterising patients with MLTC-M and describing their healthcare resources use. We will include patients aged 18+ on 01 January 2018 and follow them until December 2019. We will divide the study population into distinct subgroups with different MLTC-M combinations using latent class analysis. We will apply survival analysis to find the group with the highest risk of one-year unplanned hospital admission, as a proxy for both bad health status and high healthcare resource consumption. We will carry out further analysis on that group to describe the key risk factors, including sociodemographic, health measurements, and lifestyle factors. Lastly, we will quantify their utilisation of both primary and secondary healthcare resources.
The findings of this study can help inform future interventions directed towards people with MLTC-M. The health providers designing these interventions will have a clear plan on who to include in their studies, how to tailor the personalised psychosocial care, which risk factors to address, and outcomes to measure.
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Evaluating and addressing the impact of COVID-19 restrictions on electronic health records in estimating causal effects: oral fluoroquinolone antibiotics and tendon rupture — Yun "Angel" Wong ...
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Evaluating and addressing the impact of COVID-19 restrictions on electronic health records in estimating causal effects: oral fluoroquinolone antibiotics and tendon rupture
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-21
Organisations:
Yun "Angel" Wong - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeremy Brown - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jonathan Bartlett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Marleen Bokern - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Tendon rupture
Description: Lay Summary
Electronic health records (EHRs) are collected as part of routine healthcare in GP and hospital settings. These records are made anonymous and given to researchers for approved research projects as they contain information on diagnoses of health conditions from routine healthcare settings. During the COVID-19 pandemic, access to healthcare was disrupted and patients may have been reluctant to seek care for non-COVID health conditions, leading to disease diagnoses being either delayed or missed. These changes to when and how health data was recorded cause âmeasurement errorâ in research studies using these data. In consequence, these studies could yield flawed results.
Our study aims to determine and quantify potential measurement errors in data relating to the use of fluoroquinolones (an antibiotic class) and their adverse drug reaction tendon rupture (which is injury to the soft tissues that connect muscles and joints) in the study period of 1/1/2006-31/12/2023. We will use primary care data from the UK Clinical Practice Research Datalink Aurum database linked with hospital and death registration records. We will describe trends of diagnoses for tendon rupture over time. We will compare the risk of tendon rupture outcomes between fluoroquinolones and its alternative antibiotic, cephalosporin, and then compare results from before the pandemic to the results after. We will also explore whether novel statistical techniques can be used to successfully handle pandemic-related measurement errors. This study will improve the quality of future research by providing techniques to assess and correct measurement errors that occurred during the pandemic.
Technical SummaryCOVID-19 pandemic lockdowns have led to changes in recording in electronic health records, potentially leading to measurement and misclassification errors in research estimating causal effects. This study will identify and quantify potential measurement errors using a case study that investigates the well-established effect of fluoroquinolones on tendon rupture, compared with cephalosporin. We will use data from the UK Clinical Practice Research Datalink Aurum linked with Hospital Episode Statistics and Office for National Statistics between 2006-2023. By categorising three periods which are pre-, during and post-pandemic, we will describe absolute rates of disease diagnoses for the identification of tendon rupture; and comparing treatment effects using pre-pandemic data only with that combining pre-, during and post-pandemic data. We will estimate odds ratios and hazard ratios for tendon rupture comparing the use of fluoroquinolones with cephalosporin, using propensity score methods to control for confounding. The findings will be validated against a previous cohort study. We will identify and quantify measurement errors using a period-treatment interaction to evaluate treatment effects in each period. We will explore the use of a number of statistical techniques to correctly handle pandemic-related measurement errors, including a Bayesian approach, the simulation-extrapolation method, and quantitative bias analysis. This study will improve the quality of future causal research by providing statistical techniques to assess and correct measurement errors due to changes in diagnostic recording throughout the pandemic.
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CENTAURI: InduCEd Vasomotor symptoms, eNdocrine TherApy Utilization Patterns, and HealthCare Resource UtilizatIon and Costs among Women with Breast Cancer in the UK — Julie Dorey ...
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CENTAURI: InduCEd Vasomotor symptoms, eNdocrine TherApy Utilization Patterns, and HealthCare Resource UtilizatIon and Costs among Women with Breast Cancer in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-03
Organisations:
Julie Dorey - Chief Investigator - Bayer HealthCare SAS
Julie Dorey - Corresponding Applicant - Bayer HealthCare SAS
Alessandra Lacetera - Collaborator - OXON Epidemiology - Spain
Bélène Podmore - Collaborator - OXON Epidemiology - Spain
Claudia Rey Carrascosa - Collaborator - OXON Epidemiology - UK
Cono Ariti - Collaborator - OXON Epidemiology - Spain
Irene Mayorga - Collaborator - OXON Epidemiology - Spain
Julia Agúndez - Collaborator - OXON Epidemiology - Spain
Lyndsi Licona - Collaborator - OXON Epidemiology - Spain
Motahhareh Nadimi - Collaborator - Bayer AG
Yik Ming Fung - Collaborator - Bayer AGOutcomes:
Primary outcomes: healthcare resource utilisation (HCRU); costs.
Secondary outcomes: prevalence of vasomotor symptoms (VMS); first breast cancer (BC) recurrence; overall survival; early discontinuation.Description: Lay Summary
Many women with breast cancer receive hormone treatments like tamoxifen after surgery and radiotherapy to lower the chances of their cancer coming back (called recurrence) and to increase their chance of living longer. However, up to 95% of premenopausal women and 30% of postmenopausal women who had their breast cancer diagnosed in the early stage of their disease, experience hot flashes as a side effect of these treatments. These symptoms can be so uncomfortable that 25-60% of women stop their hormone therapy, which increases the risk of their cancer returning.
Women who are diligent and take their hormone therapy as recommended (called adherence) are less likely to need additional cancer-related healthcare due to their lower risk of recurrence. However, this may be mitigated in the short term if there are more doctorsâ visits and hospital appointments due to the hot flashes that are a result of the hormone therapy.
With that in mind this present study will investigate how adherence to hormone therapy affects the use of healthcare services and the impact of the resulting healthcare costs. By analysing existing health data, the study aims to provide important insights that could help doctors improve how breast cancer is treated. Continuing to follow the recommended hormone treatment could lead to reducing the number of doctor visits and other health care services needed, resulting in a benefit to public health by providing a better quality of life for women with breast cancer.
Technical SummaryThis study aims to describe and determine whether there are differences in costs and healthcare resource utilization (HCRU) between patients with breast cancer (BC) who are adherent and non-adherent to adjuvant endocrine therapy (ET). This study will additionally describe the prevalence of vasomotor symptoms (VMS) during follow-up (i.e., after index date) in patients who are adherent and non-adherent to adjuvant ET, describe the risk of first BC recurrence and overall survival in follow-up (i.e., after index date) in patients who are adherent and non-adherent to adjuvant ET and identify factors that may be associated with early discontinuation of ET.
This will be an observational, retrospective, cohort study. The study population will be female patients aged 18-70 years, with a diagnosis of stage 0-III BC who initiate adjuvant ET between 01 January 2009 and 31 January 2019. To allow for a minimum of 12 months look-back period, data will be requested from the 01 January 2008 and up to 31 January 2020. The study will be conducted using CPRD Aurum in England linked to Hospital Episode Statistics, Death Registration Data, Cancer Registration Tumor and Treatment, and Systemic Anti-Cancer Treatment Data.
The analyses will be descriptive. For the determination of adherence exposure, patient follow-up will be divided into 90-day segments, with the proportion of days covered (PDC) calculated for each. Adherence (PDC ⥠80%) will be recorded as a time-varying binary variable. A pooled logistic regression model will then estimate propensity scores for adherence, generating inverse probability weights for treatment and censoring, which will be applied in marginal structural models.
Understanding the effects of non-optimal ET adherence will highlight its importance to patients, healthcare providers, and policy-makers and will help to understand the areas for improvement in the delivery of care for patients with breast cancer.
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Alcohol use and risk of dementia: a historical cohort study — Anya Topiwala ...
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Alcohol use and risk of dementia: a historical cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-17
Organisations:
Anya Topiwala - Chief Investigator - University of Oxford
Anya Topiwala - Corresponding Applicant - University of Oxford
Joel Gelernter - Collaborator - Yale University
Klaus EBMEIER - Collaborator - University of Oxford
Thomas Nichols - Collaborator - University of OxfordOutcomes:
PRIMARY: All-cause dementia; Alzheimerâs disease; vascular dementia; Lewy body dementia; Parkinsonâs disease dementia; frontotemporal dementia/Pickâs disease; cognitive impairment;
SECONDARY: All-cause mortality; institutionalization [care home]; neuropsychiatric symptoms [agitation/aggression, psychosis].
Description: Lay Summary
Background: The combined threat of an aging population and rising alcohol consumption mean alcohol-related harm is likely to increase in the near future. It has been known for some time that heavy drinking over long periods can lead to dementia, a group of diseases associated with declining brain function. My recent work has shown adverse brain effects with even moderate drinking. Given the lack of treatments for dementia, we urgently need to understand how potentially preventable factors, such as alcohol, can contribute.
Purpose: One key unknown, that we propose to investigate here, is whether alcohol impacts different types of dementia, such as Alzheimer's disease, or whether it makes the brain vulnerable in general. Secondly, we want to see whether individuals who drink and develop dementia, have a worse prognosis than those who do not drink.
Importance: This project will generate fundamental insights into how alcohol consumption can lead to dementia, and inform treatment strategies. We also hope to have better information to give dementia patients and their families.
Technical SummaryBACKGROUND: Alcohol-related dementia has suffered research neglect despite high clinical need. Clarity of relationships between alcohol and dementia is vital, given the widespread population exposure to alcohol and the lack of disease-modifying treatments for dementia.
OBJECTIVE: Investigate whether alcohol intake associates with the risk and clinical course of common and rarer dementia subtypes.
EXPOSURE: Alcoholic drinks weekly (where recorded), clinically-diagnosed harmful/dependent alcohol use (identified using relevant ICD codes in primary care and HES records).
OUTCOMES: 1) Primary: Incident dementia subtypes, identified using relevant read/ICD codes in primary care and HES records; 2) Secondary: date of death (from ONS linked data), institutionalisation as recorded either in primary care (read code of event or observation date) or HES (admitted/discharged to a care home), neuropsychiatric symptoms (agitation/aggression, psychosis read codes and/or anti-psychotic prescription).
METHODS: Associations between alcohol use and dementia subtype incidence will be estimated using Cox proportional hazards regression, controlling for known measured confounds (age, sex, deprivation, ethnicity, smoking, medical comorbidities). In the case of competing risk from death, sub distribution hazards will be calculated. In secondary analyses, alcohol-related dementia (defined as any cause dementia in those with any read code for heavy/dependent drinking) will be compared to non-alcohol-related dementia (defined as any cause dementia in the absence of heavy/dependent drinking code). Cox proportional hazards models will examine whether time to death/institutionalization differs for alcohol-related vs. non-alcohol-related dementia. Logistic regression will be used to assess whether the odds of neuropsychiatric symptoms differ for alcohol-related dementia.
IMPACT: The project will generate fundamental insights into which dementia subtypes associate with alcohol intake, which will inform treatment strategies, including whether existing dementia drugs could be repurposed for alcohol-related dementia.
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Preconception Haemoglobin Levels and Associated Maternal and Neonatal Pregnancy Outcomes: A UK-Based Retrospective Cohort Study — Simon J Stanworth ...
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Preconception Haemoglobin Levels and Associated Maternal and Neonatal Pregnancy Outcomes: A UK-Based Retrospective Cohort Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-29
Organisations:
Simon J Stanworth - Chief Investigator - University of Oxford
Sarah Haynes - Corresponding Applicant - University of Oxford
Akshay Shah - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Innocent Erone - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Suzanne Maynard - Collaborator - University of Oxford
Vijay Maharajan - Collaborator - University of OxfordOutcomes:
Primary Maternal Outcomes: maternal mortality, preeclampsia, eclampsia, post-partum haemorrhage, gestational diabetes, gestational hypertension
Primary Birth Outcomes: live birth; miscarriage, still-born, birth by caesarean section, preterm birth
Secondary Outcomes: maternal anaemia during pregnancy, maternal iron deficiency during pregnancy, neonatal growth restriction (including intra-uterine growth restriction, small for gestational age, low birth weight), maternal post-partum depression
Description: Lay Summary
Anaemia, a condition where the body lacks enough healthy red blood cells, is common in pregnant women and can have serious health effects for both the mother and baby. Anaemia is diagnosed with a blood test that measures haemoglobin. Haemoglobin is the part of a red blood cell that carries oxygen around the body, and it is low in people with anaemia. Low haemoglobin or anaemia can cause tiredness, shortness of breath, and complications during pregnancy such as large bleeds for the mother during childbirth or low birth weight in the baby. The main cause of anaemia in pregnancy is a lack of the nutrient iron or âiron deficiencyâ.
This study will explore whether a womanâs haemoglobin levels before pregnancy are linked to health outcomes for her and her baby. Using anonymised health records from across the UK, the research will investigate whether haemoglobin levels measured before pregnancy are associated with negative health outcomes for the mother and baby during or after pregnancy.
By studying this relationship, the findings could help improve clinical guidelines for screening and preventing anaemia in pregnancy. Ultimately, this research aims to enhance the care provided to women before and during pregnancy, leading to better outcomes for both mothers and their babies.
Technical SummaryBackground:
Anaemia, primarily iron deficiency (ID), affects one-third of the global population, disproportionately impacting women of reproductive age (WRA) due to increased iron needs during menstruation and pregnancy. In the UK, approximately 10.9% of WRA and 23% of pregnant women are anaemic (1). Anaemia in pregnancy is associated with increased risks of adverse maternal and neonatal outcomes, such as preterm birth, preeclampsia, and postpartum haemorrhage (2â7). Despite these risks, there is limited research on how preconception haemoglobin levels impact pregnancy outcomes, resulting in a gap in understanding early intervention opportunities.Aim and Objectives:
The primary aim is to explore the association between preconception haemoglobin levels and adverse maternal and neonatal outcomes in pregnant women. We will describe the number and proportion of women with haemoglobin testing before pregnancy, by demographic factors and examine the relationship between preconception haemoglobin levels and pregnancy and neonatal outcomes.Methods:
This is a retrospective cohort study based CPRD Aurum including pregnant women. We will describe the demographics of pregnant women and the prevalence of haemoglobin testing in the 6 months before pregnancy start. Pregnancies will be defined from the CPRD Pregnancy Register. Logistic regression models will be used to assess the association between preconception haemoglobin levels and adverse maternal and birth outcomes adjusting for potential confounders. The Mother-Baby link, HES APC and ONS data will be used to define adverse outcomes and the Ethnicity and IMD linkage will be used to describe patient demographics.Impact:
The findings will guide improvements in diagnosing and managing anaemia before and during pregnancy, with potential implications for primary care guidelines and better outcomes for maternal and neonatal health.
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Population-level incidence, prevalence, characterisation and outcomes in conditions of regulatory interest — Daniel Prieto...
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Population-level incidence, prevalence, characterisation and outcomes in conditions of regulatory interest
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-02
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Marta Pineda Moncusi - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Anna Saura-Lazaro - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Wanning Wang - Collaborator - University of Oxford
Xintong Li - Collaborator - University of OxfordOutcomes:
Summary characteristics (sex, age, risk factors, comorbidities, comedication, measurements and procedures) in the population of interest.
Incidence and/or prevalence of conditions of regulatory interest
Incidence and/or prevalence of outcomes among a specific population of interestCondition of regulatory interest:
-benign prostatic hyperplasia (BPH)
-androgenetic alopecia
-(obstructive) hypertrophic cardiomyopathy (oHCM/HCM)
-venous thromboembolic events
-cancer of interestOutcomes in a population with a condition of regulatory interest:
-Completed suicide (observation record of suicide plus death date in the following 30 days), Attempted suicide, Suicide ideation, Intentional self-harm, and/or combination of any of them.
-venous thromboembolic events
-eye disorderDescription: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe.
One area of research relates to describing characteristics, such as age and sex, of people diagnosed with a condition of interest, the frequency of this conditions in the general population, and the frequency of other conditions and diseases associated with the population with a condition of interest. The description of the characteristics, frequency of the condition of interest and associated diseases and conditions are important from a regulatory point of view to provide context and help understand its impact on patients.
The EMA will request several studies of the same design to assess how common specific conditions - and conditions and diseases associated with them - are in the population. This will help the regulators to inform preventative measures that could be introduced to reduce disease spread or disease burden, and subsequently reduce risk for consequences, including risk of death, for affected people wherever possible. The first example will focus on enlarged prostate and hair loss, two conditions that could potentially be linked to suicide-related events in adult male patients related to these two conditions.
Technical SummaryTo understand patient characteristics and the incidence and prevalence of conditions of regulatory interest for evaluating disease burden in the population, the European Medicine Agency (EMA) will commission several disease epidemiology studies to the DARWIN Coordination Centre. Data sources have been mapped to the OMOP-common data model before analysis.
Objectives
-To characterise the population of interest
-To estimate the incidence and prevalence of conditions of regulatory interest in the source population, and outcomes in a population with a condition of regulatory interest, stratified by calendar year, age and sex.Study design: Cohort study
Population: All people in CPRD GOLD or AURUM. Additional inclusion criteria may include >=1 year of prior history, initiation of relevant treatments, record of a specific condition/diagnosis, and exclusion of specific conditions to prevent misclassification.
Outcomes
-Characterisation of individuals in the population of interest.
-Conditions of regulatory interest: androgenetic alopecia, benign prostatic hyperplasia, (obstructive) hypertrophic cardiomyopathy, cancer of interest.
-Outcome in a population with a condition of regulatory interest: completed suicide, attempted suicide, suicide ideation, intentional self-harm, and/or combination of any of them; venous thromboembolic events; eye-disorder.
Additional conditions and outcomes will be declared in future protocol amendments upon request by EMA.Covariates:
>For craterisation: age, sex, risk factors, comorbidities, comedication, measurements and procedures, among others.
>For the incidence and prevalence analysis: age, sex, calendar time, indications, other comorbidities/conditions of interest, and treatment types.
>Comorbidities/conditions for specific exclusion criteria.Methods:
-Summary statistics and/or large-scale characterisation will detail the characteristics of individuals in the population of interest (e.g. age, sex, risk factors, calendar time, comorbidities, comedications, measurements and procedures). Numeric variables will be reported as median(IQR), and categorical variables will be presented as N(%).
-Incidence and prevalence will be reported with the corresponding 95% confidence intervals. Where numbers allow, we will report stratified by the covaries specified above.
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How are remission codes for severe mental illness used in primary care and how does this vary by type of practice and patient? An observational study using national primary care register data. — Peter Schofield ...
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How are remission codes for severe mental illness used in primary care and how does this vary by type of practice and patient? An observational study using national primary care register data.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-30
Organisations:
Peter Schofield - Chief Investigator - King's College London (KCL)
Peter Schofield - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
James Scuffell - Collaborator - King's College London (KCL)Outcomes:
A binary variable indicating whether patient is coded as in remission from serious mental illness in any given year. See attached document ("SMI Remission codes.xlsx") for a list of these (SNOMED) codes.
Description: Lay Summary
Serious mental illness (SMI), such as schizophrenia and bipolar disorder, has historically been seen to offer little hope of recovery. However, in recent decades, this view has changed with many understood to go on to make a full recovery. This has had a major influence on United Kingdom mental health services with the widespread adoption of a ârecovery modelâ in psychiatry. Primary care also plays a central role in SMI treatment, however, the extent to which a recovery model has been adopted in primary care is unclear. In England, General Practitioners (GPs) are incentivised to keep a register of all those with SMI. To be removed from the register a "remission code" is entered. Our preliminary analysis, using GP data from Lambeth (South-East London) found these codes were rarely used. Since 2005, only 6.8%, 715 out of 10,500 on the SMI register, received these codes. For this exploratory study we will look at all patients across England to see how these codes are used, and for whom, and how this fits with what we already know about recovery. This is important for public health as a continuing diagnosis is unnecessarily stigmatising for recovered patients. It is also a potential waste of resources, with those on the register required to attend extra annual health checks. This initial analysis will also prepare the groundwork for subsequent primary care research investigating the role of primary care in recovery from SMI.
Technical SummaryBackground
Many patients with serious mental illness (SMI) are now understood to go on to make a full recovery and a ârecovery modelâ is now well established in secondary mental health care. Primary care plays a central role in their treatment, however, the extent to which a recovery model has been adopted in primary care is less clear. In England GPs are incentivised to keep an SMI register and as patients recover a remission code must be entered. Concerns have been raised about the accuracy of SMI registers.
Overarching study aim and objectives
The study aims to document the use of remission codes to remove patients from the practice SMI register. Specific objectives are to estimate overall use of these codes and their use at specific time points after patients are first entered on the register, as well as examining practice variation in coding and patient and practice level factors associated with coded remission.
Primary exposure(s), and outcome(s)
The primary outcome is a remission code in any given year and exposures are ethnicity, patient (neighbourhood) level deprivation, age, gender and use of antipsychotic medication.
Study design, and methods
Longitudinal cohort study of remission rates based on time from first appearance on the SMI register to the date on which a remission code is first entered. Presence on the SMI register will be defined by the recording of a medical code denoting an SMI diagnosis between 01/01/2005 and 31/12/2023. Analysis period would be from 01/03/2005 to 30/09/2024.
Statistical tests
Relative frequency of coded remission at different time points. Chi-squared tests for associations between patient and practice level factors and coded remission.
Survival analysis (cox regression, Kaplan-Meier curves and median time) of time to coded remission from date first appeared on the SMI register. Mixed-effects Poisson regression to examine practice level variation.
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Recording of post-traumatic stress disorder (PTSD) diagnoses and symptoms in UK primary care — Daniela Strelchuk ...
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Recording of post-traumatic stress disorder (PTSD) diagnoses and symptoms in UK primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-03
Organisations:
Daniela Strelchuk - Chief Investigator - University of Bristol
Daniela Strelchuk - Corresponding Applicant - University of Bristol
Charlotte Archer - Collaborator - University of Bristol
David Kessler - Collaborator - University of Bristol
Nicola Wiles - Collaborator - University of BristolOutcomes:
The overarching aim of this study is to examine trends in the incidence and prevalence of PTSD symptoms and diagnoses as recorded in UK primary care between 2003 and 2023. We will also examine if there are any differences in the recording of PTSD symptoms and diagnoses based on peopleâs age, sex, ethnicity and deprivation.
Description: Lay Summary
Many people who visit their general practitioner (GP) have experienced trauma (e.g. physical, emotional or sexual abuse). As a result of this trauma, some people develop symptoms of a mental health condition called âpost-traumatic stress disorderâ (PTSD). These symptoms include re-living the traumatic event in the form of nightmares, avoidance of people or places which are a reminder of the trauma, and difficulties relaxing or being easily startled. Left untreated, PTSD can last for many years.
Even though treatment for PTSD is highly effective, there are obstacles to the recognition of people with PTSD in primary care. These obstacles are related to a high overlap between symptoms of PTSD and symptoms of other mental health illnesses, and patients not disclosing their PTSD symptoms during conversations with their GP. As people can only be offered treatment after they have been recognised as suffering from PTSD, it is important that we have an accurate understanding of how GPs record PTSD in patientsâ clinical notes. Only one study has so far examined the recording of PTSD in UK primary care, and this study has some important limitations.
Our study aims to overcome the limitations of previous research, and will examine the recording of PTSD in UK primary care. Results of this study will inform future clinical practice and research on the recognition of, and treatments for, people with PTSD in primary care.
Technical SummaryPost-traumatic stress disorder (PTSD) is associated with high use of primary care services. However, a number of studies have suggested that people with PTSD are not identified in primary care.
This study aims to examine trends in the incidence and prevalence of PTSD symptoms and diagnoses as recorded in UK primary care between 2003 and 2023 using data from the CPRD Gold and Aurum. The study will use a retrospective cohort design, including patients aged 18 or over in CPRD who have a PTSD code between 1st January 2003 and 31st December 2023.
We will calculate the number of incident cases of PTSD (defined by a PTSD symptom code or a diagnosis code) in each calendar year, and the prevalence of PTSD in each year. Person-years at risk will be used as the denominator. Incidence rates and 95%CI will be calculated using Poisson regression. The prevalence of PTSD will be defined as the proportion of people with a recorded PTSD code in each year. Estimates and 95%CI based on the Poisson distribution will be calculated. Data will be stratified by age, sex, ethnicity and deprivation. Changes in trends over time will be examined using joinpoint regression.
This study will provide important insights into the recording of PTSD in UK primary care. Findings will inform further research on how to better identify people with PTSD in UK primary care.
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Exploring a no biopsy approach for coeliac disease diagnosis — Martha Elwenspoek ...
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Exploring a no biopsy approach for coeliac disease diagnosis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-08
Organisations:
Martha Elwenspoek - Chief Investigator - University of Bristol
Martha Elwenspoek - Corresponding Applicant - University of Bristol
Aws Sadik - Collaborator - University of Bristol
Howard Thom - Collaborator - University of Bristol
Katie Charlwood - Collaborator - University of Bristol
Penny Whiting - Collaborator - University of Bristol
Yixin Xu - Collaborator - University of BristolOutcomes:
The rate of tTG testing (code list 1), measured as tests per practice proxy list size, describing regional, temporal, and demographic variations.
Estimates for the economic model: long-term adverse CD outcomes (code list 5) and biopsy-related adverse events (code list 6).
If it is possible to define a population who is tTG positive: the proportion receiving follow-up tests (code list 2, code list 3), a formal CD diagnosis (code list 4), waiting times from the first positive tTG to biopsy/referral and diagnosis, and the proportion of tTG-positive patients who might benefit from a no-biopsy pathway (avoiding biopsies and diagnostic delays).Description: Lay Summary
This study will look at how people are diagnosed with coeliac disease, a condition caused by an immune reaction to gluten that requires a lifelong gluten-free diet. Currently, diagnosis involves a blood test followed by a small intestine biopsy to confirm the condition. The biopsy process can be uncomfortable, involve long waits, and is less accurate for people already on a gluten-free diet. Our research will explore a simpler "no-biopsy" pathway, where some people could be diagnosed using blood tests alone. This approach could make the process faster, less invasive, and improve the overall experience for patients.
Technical Summary
We will examine how coeliac disease blood tests are used across England, looking at differences based on location, age, and sex. The study will count how many people are referred for biopsies, how long they wait between tests, and how often biopsies confirm the diagnosis. We will also analyse whether the no-biopsy pathway could save money while still achieving good long-term health outcomes.
By estimating how many people could benefit from this approach, we aim to improve diagnosis processes, making them more efficient and accessible. Findings will be shared with groups like Coeliac UK, clinical experts, and published in medical journals to help improve care for people with coeliac disease.This study aims to assess the diagnostic pathways for coeliac disease (CD), focusing on the potential for a "no-biopsy" diagnostic approach. CD is an autoimmune condition triggered by gluten that requires a strict, lifelong gluten-free diet as its only treatment. Standard diagnostic practice involves a blood test for tissue transglutaminase antibodies (tTG), followed by a confirmatory duodenal biopsy. However, this biopsy process is invasive, requires a period of gluten consumption beforehand to ensure accuracy, and often results in long wait times. The need for biopsy can delay diagnosis, particularly for patients who have already begun a gluten-free diet based on blood test results alone.
Our study will evaluate the potential for diagnosing CD without biopsy in cases where blood test results alone are sufficiently definitive. We aim to examine tTG testing rates in primary care in England, calculating testing rates per practice proxy list size and examining variations by demographic and geographic factors. Among patients testing positive for tTG, we will quantify those receiving follow-up testing, referrals, and biopsy confirmations, as well as calculate waiting times from initial positive tTG to biopsy and diagnosis. We will also estimate the number of patients who might be diagnosed without biopsy, reducing both diagnostic delays and patient burden.
Additionally, a health economic model will estimate the cost-effectiveness of various no-biopsy diagnostic pathways, including potential outcomes like Quality Adjusted Life Years (QALYs), avoided biopsies, and unnecessary gluten-free diet prescriptions. We will estimate long term adverse outcomes and biopsy related adverse effects in CPRD, which will feed into this model. The results will inform diagnostic guidelines and clinical practices, aiming to improve accessibility and timeliness of CD diagnosis. Findings will be shared with Coeliac UK, clinical guideline committees, and published in peer-reviewed journals to support broader adoption of more efficient diagnostic pathways.
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Understanding the impact of cancer related risk factors on incidence, prevalence and survival of cancers in individuals under 50 years of age — Danielle Newby ...
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Understanding the impact of cancer related risk factors on incidence, prevalence and survival of cancers in individuals under 50 years of age
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-17
Organisations:
Danielle Newby - Chief Investigator - University of Oxford
Danielle Newby - Corresponding Applicant - University of Oxford
Alice Hinchliffe - Collaborator - CPRD
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Patricia Pedregal Pascual - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
Cancer diagnosis; mortality
Description: Lay Summary
Cancer rates are increasing in younger adults, particularly in high-income countries. Many cancers such as bowel and breast cancer are on the rise for people born after the 1960s, but the reasons behind this are not fully understood. Lifestyle risk factors like obesity and diabetes may play a role.
By studying cancer trends over time in different generations (e.g. baby boomers, millennials) in people with and without these lifestyle risk factors, we can learn more about possible causes for young onset cancers. This information can be used to help inform cancer prevention programs for younger people.
This study will analyse data from people in the CPRD GOLD and AURUM databases to see how many people have cancer and how long they live after they are diagnosed with cancer for people aged 18 to 49. We will see if this changes depending on a personâs sex, year of birth and lifestyle risk factors. We will compare the medical histories of young cancer patients to those of similar individuals without cancer to see if there are patterns that could provide insights into the causes of rising cancer rates in younger generations.
Technical SummaryBACKGROUND: Cancer incidence rates are rising in high-income countries, particularly among younger adults. The increase in young-onset cancers, like colorectal and breast cancers, suggests a birth cohort effect for those born after the 1960s, with causes still largely unknown. Environmental and lifestyle factors, such as obesity and type 2 diabetes have been highlighted as key factors. Understanding the trends of cancer trends in different birth cohorts in those with and without certain risk factors can generate hypothesis on the aetiology that could be used for further research which could then inform on possible lifestyle behaviours that can be targeted/intervened upon in cancer prevention programs for younger populations.
STUDY DESIGN: Cohort study
POPULATION: All people in aged 18 to 49 years CPRD GOLD and AURUM between 2000 and 2024 with at least 365 days of data availability.
CANCERS OF INTEREST: Cancers highlighted as rising in younger populations (Colorectal, Breast, Prostate, Endometrial, Head and neck, Kidney, Oesophageal and Thyroid)
ANALYTICAL METHODS
1) Estimation of annual period prevalence, annual incidence rates and overall survival (death by any cause) of cancer in those aged 18 to 49 years of age stratified by year of birth group, sex and cancer risk factors (e.g. type 2 diabetes, obesity). Denominator will be persons aged 18 to 49 years between 2000 and 2024.
2) Characterisation of young onset cancer patients (aged 18 to 49 years), including medical history and co-medication use before, on and after cancer diagnosis stratified by birth cohort, cancer related risk factors, and sex. Characteristics of young onset cancer patients will also be compared to age and sex matched controls.
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Referral patterns and access to Stem cell transplant: A retrospective population-based study in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) patients in England — Joht Singh Chandan ...
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Referral patterns and access to Stem cell transplant: A retrospective population-based study in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) patients in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-09
Organisations:
Joht Singh Chandan - Chief Investigator - University of Birmingham
Zareen Deplano - Corresponding Applicant - University of Birmingham
Elisa Allen - Collaborator - NHS Blood and Transplant
Nicola Adderley - Collaborator - University of Birmingham
Stephanie Hanley - Collaborator - University of BirminghamOutcomes:
Outcomes to be Measured
Primary outcomes:
⢠SCT rates within AML and MDS population
⢠SCT referral rates within AML and MDS population
Key Secondary Outcomes
⢠Trends in SCT and referral rates according to SES, different regions across England , ethnicity, age, gender, and any other relevant clinical factors
⢠Overall survival (OS) and time waiting to SCT in treated and untreated cohortsDescription: Lay Summary
Barriers to healthcare due to health inequalities may lead to some patients in our society not receiving certain treatments or being treated differently when they are ill because of their age, gender, ethnic minority group, where they live, the language they speak, their education and income.
Technical Summary
In this study, we are interested in the barriers patients face in accessing Stem cell transplantation (SCT), a life-saving treatment for patients with some blood cancers. Blood cancers are the fifth most common cancers in the UK and the third biggest cause of cancer related death.
Research work in SCT shows that patients from ethnic minority/mixed heritage groups find it harder to find a donor because most donors are from a white background. This affects their chances of receiving a SCT and their blood cancer to be treated.
However, we lack information on earlier in the process when a patient is diagnosed with blood cancer and treatments they are offered. The questions we are interested in answering in this study are: 1) Are all SCT eligible patients referred 2) What are the number of SCT eligible patients who are not referred 3) What factors affect referral to SCT 4) What are the differences in number of SCT performed according to factors such as patient age, gender, ethnic group and area they live in and the level of deprivation they experience. Better understanding of these barriers will help inform public health policy to level up access and improve survival of patients with blood cancer.To describe trends in access to SCT and referral patterns according to patient demographic characteristics ethnicity, socioeconomic factors and different regions across England.
1. To determine the number of Acute Myeloid Leukemia (AML) Myelodysplastic Syndromes (MDS) patients eligible for SCT based on age, Co-morbidity Index (CI), cytogenetics risk stratification (if data allows)
2. To determine SCT rates in the AML MDS patient cohort
3. To determine rates of referral to SCT in the AML MDS patient cohort
4. To explore trends in SCT and referral according to different regions across England, socio-economic factors, age, gender, ethnicity, date of diagnosis, treatment date, CIStudy design, method and Statistical analysis
Our patient cohort will consist of all patients who contribute to CPRD AURUM and linked to Hospital Episode Statistics (HES) Outpatient (OP) and Admitted Patient Care(APC), between 1st January 2001 to present date, age 18 or above. Total cases of AML MDS diagnosis will be selected. AML MDS patients will be defined based on transplant eligibility criteria ageâ¤75yrs, molecular/cytogenetic risk, CI:
CPRD linked to OP, APC, National Cancer Registration Analysis Service (NCRAS) Cancer Registration, small level Index Multiple Deprivation(IMD) datasets will used.
Variables including patient demographics, ethnicity, socioeconomic status (SES), CI and different regions across England will be used to explore trends in access to SCT and referral patterns.
Statistical analysis will be conducted using descriptive statistics to explore differences in patient demographics. Fisherâs exact / Chi-squared tests will be used to evaluate differences between categorical variables and Wilcoxon Mann-Whitney test for continuous variables for referral and transplant rate. Time waiting to SCT will be analysed using survival methods such as Kaplan Meier method and or Cox proportional hazard regression unadjusted and adjusted hazard ratios (aHRs) with 95% CI. Adjustment will be done for age, gender, ethnicity, deprivation, and comorbidities.
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Prevalence and socioeconomic and geographic associations in type 2 diabetes with comorbid depression and anxiety in the UK — Daniel Prieto...
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Prevalence and socioeconomic and geographic associations in type 2 diabetes with comorbid depression and anxiety in the UK
Datasets:GP data, CPRD GOLD Ethnicity Record; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-24
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Anna Saura-Lazaro - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
1.Type 2 diabetes mellitus (T2DM);
2.Depression;
3.Anxiety;
4.Concomitant diagnosis of T2DM with depression and/or anxietyDescription: Lay Summary
Diabetes, a growing problem in the UK affecting over 4 million people, is a chronic condition that affects how the body processes blood sugar leading to elevated blood sugar levels, which can cause serious health issues over time.
Depression and anxiety are common mental health problems and are more likely among individuals with diabetes. Likewise, people with depression and/or anxiety are at a higher risk of developing diabetes. People with lower income or education levels may struggle more with both conditions.By studying medical and sociodemographic data, the researchers hope to better understand how these conditions affect people differently based on where they live or their income. We aim to use the results to design better healthcare interventions for people with both diabetes and depression/anxiety.
This study looks at how common it is for people in the UK to have both diabetes and mental health conditions, such as depression and anxiety. It will also explore how where people live and their income level affect these conditions. The study will collect information on adults with both diabetes and depression/anxiety, and check that their medical records are accurate and usable for research. It will also look at details like age, gender, ethnicity, other health issues, and treatments undergone. All these analyses will inform the design of future research into the use and impact of digital technologies such as phone apps, created to assist the patient in management of their conditions.
Technical SummaryOverarching aim and objective(s)
The overarching aim of this study is to phenotype and characterise type 2 diabetes mellitus (T2DM), depression, anxiety, and their coexistence using National Health Service (NHS) primary care records.
The specific objectives are: i) to determine the prevalence of T2DM with comorbid depression and/or anxiety, and ii) to explore the socioeconomic and geographic factors influencing comorbid T2DM with depression and/or anxiety.Study population of interest
Individuals aged 18 or older, registered in CPRD GOLD, diagnosed with T2DM and depression and/or anxiety between 1st January 2004 and 31st July 2024. Four cohorts will be defined:
i) T2DM and depression
ii) T2DM and anxiety
iii) T2DM, depression, and anxiety
iv) T2DM with depression or anxietyPrimary exposure(s) and outcome(s), where relevant
The primary outcomes are diagnoses of T2DM and comorbid depression and/or anxiety, identified using validated algorithms within CPRD GOLD. Covariates include sociodemographic data (age, sex, ethnicity, Townsend Deprivation score), clinical assessments (blood pressure, weight, etc.), lifestyle factors (smoking, alcohol consumption, etc.), and most common medications.
Data sources
CPRD GOLD data linked with Townsend Deprivation score information.
Study design, methods including the main statistical tests
This study is descriptive and hypothesis-generating, using a cohort design to analyse routine primary care patient data. Phenotyping will be carried out through systematic code searches and validated by clinicians. Descriptive statistics will summarise data for each cohort, and point prevalence estimates will be calculated annually (2004-2024) stratified by socioeconomic status and geographic region.
Intended public health benefit of the research
The findings of this analysis will demonstrate the feasibility and statistical power of using primary care data to identify patients with multimorbidity of T2DM and depression/anxiety, and inform the design of future studies aimed at improving care among people with T2DM and comorbid depression/anxiety.
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Impact of ambient environmental exposures on mental healthcare service utilisation and treatment for acute mental and behavioural disorders among adults in England; a time series study. — Suzanne Bartington ...
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Impact of ambient environmental exposures on mental healthcare service utilisation and treatment for acute mental and behavioural disorders among adults in England; a time series study.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-03
Organisations:
Suzanne Bartington - Chief Investigator - University of Birmingham
Chee Yap Chung - Corresponding Applicant - University of Birmingham
Abeer Albdour - Collaborator - University of Birmingham
James Hall - Collaborator - University of Birmingham
Zongbo Shi - Collaborator - University of BirminghamOutcomes:
Primary outcomes: Daily hospitalisation counts where the patient was admitted (to an organisation site, service point, or hospital provider) where the main treatment is for adult mental illness or behavioural disorder (ICD-10: F00-F99)
Secondary outcomes:
⢠HES : Total number of bed days⢠CPRD: GP appointment attendance, prescription of antidepressant and anti-anxiolytic, anti-depressant and anti-psychotic medications for patients with mental and behavioural disorders.
Description: Lay Summary
Climate change is leading to more frequent and extreme weather events in the UK, including heatwaves, flooding, and storms. High temperatures can also increase levels of air pollutants and allergens, leading to poorer air quality. These factors are known to influence mental health; for example, hospital admissions for psychiatric disorders tend to increase during heatwaves and high air pollution levels are linked to increased mental health service use among people living with psychotic or mood disorders. However, less is known about how these environmental changes jointly influence mental health outcomes, how the risks change over time and which groups of people are most vulnerable to these hazards.
We want to study how short-term changes in the environment associated with climate change (including temperature, air pollution) and extreme weather events (including storms, flooding and wildfires) affect mental and behavioural health of adults living in England. We will link historical weather and air pollution data from the UK Met Office with information on medication and healthcare service use among adults registered with GP practices in England between 1st January 2003 and 31st December 2019. We will analyse the linked dataset to understand how and where climate-related mental health outcomes are occurring and which patient groups are most affected.
This study is crucial for improving our understanding of how climate change might affect our mental health. The knowledge will enable public services to plan for rising temperatures, informing how healthcare services should adapt, and which vulnerable groups require protection from these emerging risks.
Technical SummaryThe impacts of climate change on mental health are potentially significant and may widen existing health inequalities (Munro et al., 2020). Understanding the complex links between environmental influences and mental and behavioural health in the UK is therefore essential, to inform targeted healthcare adaptations and improve patient outcomes (UKHSA, 2023).
Existing epidemiological studies investigating relationships between ambient temperature, air pollution and mental health have typically been performed using temporally or spatially limited modelling or measurement datasets for exposure assessment. This places several scientific limitations; long-term modelled outputs do not enable assessment of short-term effects which typically occur within days of exposures and few studies have adequately investigated synergistic influences of multiple environmental exposures occurring in combination, which can lead to an underestimation of the impact on mental health outcomes.
This time series study will analyse modelled environmental exposures and meteorological data for the 17-year period (1st January 2003 to 31st December 2019), and General Practice attendance, prescription, health and social care utilisation data for mental health disorders obtained across regions in England. Applying relevant statistical methods, including Generalised Additive (GAM) and Distributed Lag Nonlinear Models (DLNM), we will investigate the relationship between short-term exposure to ambient temperature and air pollutant concentrations, occurrence of extreme weather events and risk of acute mental and behavioural outcomes for the study period. Stratified analyses will be conducted to explore differences by socio-demographic, health, and lifestyle characteristics, and to identify regional patterns and trends.
The project will generate regional risk estimates for short-term environmental exposures and risk of acute mental and behavioural outcomes among those living in England, which may inform health impact assessment and targeted adaptation strategies to protect vulnerable patient groups.
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Global Vaccine Data Network (GVDN) Project - Background Rates of Maternal and Neonatal Outcomes — Debabrata Roy ...
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Global Vaccine Data Network (GVDN) Project - Background Rates of Maternal and Neonatal Outcomes
Datasets:GP data, CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-27
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Alison Yeomans - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Denise Morris - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Saad Shakir - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
Primary outcomes will document annual incidence of pregnancy and neonatal outcomes and adverse events of special interest (Appendix 1). These outcomes were selected based on the Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA)(1) and the World Health Organization (WHO) COVID-19 vaccines: Safety surveillance manual: module on safety surveillance of COVID-19 vaccines in pregnancy and breastfeeding women(2). While AESIs during pregnancy are based on Brighton Collaboration suggested outcomes(3). Secondary outcomes will include the incidence of outcomes (Appendix 1) stratified by subgroups including maternal characteristics (age, high-risk medical conditions, trimester) and incidence rates of outcomes quarterly for each calendar year.
Description: Lay Summary
Vaccination during pregnancy is recommended for several vaccines and given as part of routine care during pregnancy. Vaccination during pregnancy protects both the mother and baby from serious illness. The most recently recommended vaccines for use during pregnancy were the COVID-19 vaccines, although they were met with hesitancy due to the rapid roll out of these vaccines. Our linked study submitted for CPRD approval entitled âGlobal Vaccine Data Network (GVDN) Project - A multi-centre international database study evaluating maternal and neonatal safety post COVID-19 vaccination in pregnant womenâ will study the safety of COVID-19 vaccines on both the mother and the baby. In order to fully understand and put the data into perspective, a greater understanding on the background rates of maternal outcomes and outcomes of the baby (neonatal outcomes) prior to and during the COVID-19 pandemic is required. This study will determine the rate of pre-specified maternal and neonatal outcomes as well as the background rate of side effects that are potentially related to vaccination. The results from this study could be used to understand whether vaccination alters the risk of different pregnancy outcomes, neonatal outcomes or side effects, which in turn may inform clinical guidelines into the usage of vaccines, which could be important for future vaccination programmes during pregnancy.
Technical SummaryVaccination during pregnancy for multiple conditions, including COVID-19, is recommended to protect both mother and foetus(es). Vaccination results in high antibody titres in the mother that are capable of transplacental transport to the foetus(es), providing protection against infections during pregnancy and in the first few months of life, when the neonatal immune system is immature. But pregnant women are excluded from clinical trials prior to vaccine recommendations, including COVID-19 vaccination, which was recommended by the Joint Committee on Vaccination and Immunisation in the UK on 16 April 2021, therefore, there is a need to better understand the safety and efficacy of COVID-19 vaccination in pregnancy. This will be studied in a linked retrospective observation cohort study entitled: âGlobal Vaccine Data Network (GVDN) Project - A multi-centre international database study evaluating maternal and neonatal safety post COVID-19 vaccination in pregnant womenâ that is also submitted for CPRD approval. To fully interpret the findings of the linked study a greater understanding on the background incidence rates is required, this study plans to utilise an observational retrospective study design, to estimate the baseline incidence of selected maternal, obstetric, foetal and neonatal outcomes, as well as Adverse Events of Special Interest (AESI) during pregnancy. The study population (all pregnant women and their neonates between 01 January 2017 and 31 December 2023) will be ascertained using the CPRD Aurum pregnancy register and mother-baby linkage, while health outcomes will be determined using Aurum primary care records. Incidence rates of health outcomes will be calculated within defined risk windows for each outcome during the pregnancy episode. These background incidence rates will contribute to an international project to establish the safety and efficacy of COVID-19 vaccination in pregnant women and their neonates.
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Developing transdiagnostic symptom phenotypes of mental illness using primary care data (DeTraP) — Matthias Pierce ...
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Developing transdiagnostic symptom phenotypes of mental illness using primary care data (DeTraP)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-15
Organisations:
Matthias Pierce - Chief Investigator - University of Manchester
Holly Hope - Corresponding Applicant - University of Manchester
Ann John - Collaborator - Swansea University
Kathryn Abel - Collaborator - University of Manchester
Marcos Del Pozo Banos - Collaborator - Swansea University
Roberto Carlos Carrasco Gonzalez - Collaborator - University of ManchesterOutcomes:
Probability of:
a) a diagnostic label of a mental illness
b) prescription of an antidepressant, anxiolytic, mood stabiliser, antipsychotic
c) referral to mental health services
d) hospital admission for mental and behavioural disorders or self-harm/attempted suicided
e) hospital admission for cardiovascular/coronary heart disease
f) mortality (all cause)
g) death by suicide
h) premature mortality (death before 70 years).
i) cardiovascular/ coronary heart disease mortality
j) coronary heart disease mortality
k) hard to treat depressionDescription: Lay Summary
What we know now
Current mental illnesses often group many symptoms into a diagnosis such as âdepressionâ. However, many symptoms overlap across different mental illnesses. For example, sleep problems and anhedonia (the inability to feel pleasure) occur in various mental illnesses. These sorts of cross-overs can affect diagnosis and treatment outcomes. Understanding how these symptoms group together may lead to more realistic categories of mental illness and improve patient care.What is our aim?
Our aim is to understand how symptoms group together to create categories of mental illness that better represent patients. This will help researchers and clinicians understand how symptoms co-occur and progress, and to what extent they are âtransdiagnostic,â meaning they occur across mental illnesses.What we shall do
We will create a cohort of adults aged 16 to 70 using data from primary care and hospital records. By analysing their symptoms, we will describe common symptom groups and evaluate how these groups relate to diagnoses, treatments, and health outcomes such as hospital admissions and mortality. We will also explore how patient characteristics such as age and ethnicity change the chance of belonging to different symptom groups.What will this mean?
Technical Summary
This research could lead to a better understanding of mental illness in the adult population. By providing information on how symptoms group together, clinicians may be able to offer better interventions that target those symptoms. Additionally, the study will provide valuable data for policymakers and pharmaceutical companies to develop new, more effective treatments.Aim:
To better understand how mental health symptoms cluster and predict clinical outcomes.
Objectives:
1. Develop phenotypes based on symptom clusters using primary care data.
2. Assess the frequency and distribution of these symptom clusters across a representative UK population.
3. Evaluate the predictive power of symptom clusters for outcomes such as mortality, hospital admissions, and treatment resistance.
The work will be carried out across three work packages.WP1
We will create symptom phenotypes by analysing primary care data for patients aged 16 to 70, including transdiagnostic symptoms such as anhedonia and insomnia. We will stratify by age, gender, ethnicity and socioeconomic groups.WP2
Symptom clusters will be identified, and we will use network models to map highly interconnected symptoms. We will use sequence analysis to describe patterns in the progression of these symptoms and how they relate to psychiatric diagnoses. The stability of symptom clusters will be analysed across different mental illnesses (e.g. anxiety and psychotic disorders).WP3
We will investigate the association between symptom clusters and health outcomes. We will assess how these clusters predict adverse outcomes like cardiovascular disease, hospital admissions for mental illness and suicide. A time-to-event analysis will be employed to model these associations.Study Population
Adults aged 16-70 years registered with a general practice between 2015-2024.
Data Source
Primary care data from Aurum dataset, linked with HES, ONS mortality.
Study Design
Descriptive studies for WP1 and WP2, retrospective cohort studies in WP3.
Outcomes
Psychiatric disorder, CVD, mental health service use, self-harm, mortality, suicide.
Methods
Statistical analyses will include network analysis, K-means clustering, sequence analysis, Cox proportional hazards regression, and latent class approaches.
Intended Patient Benefit
This research aims to refine mental health diagnostics and improve targeted treatments by focusing on symptom-based phenotypes rather than traditional diagnostic categories.
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Validation of OMOP common data model pregnancy algorithm in CPRD GOLD — We will asses the following outcomes:...
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Validation of OMOP common data model pregnancy algorithm in CPRD GOLD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-09
Organisations:
We will asses the following outcomes:
- number of pregnant women
- pregnancy outcomes (live birth, still birth, miscarriage, ectopic pregnancies, and elective termination)
- gestational lengthOutcomes:
We will asses the following outcomes:
- number of pregnant women
- pregnancy outcomes (live birth, still birth, miscarriage, ectopic pregnancies, and elective termination)
- gestational lengthDescription: Lay Summary
Very few studies in which medication is tested before market approval include pregnant individuals as participants due to ethical concerns. Therefore, information regarding the safety and effectiveness of medication use during pregnancy must rely on studies using previously collected and anonymised patient data (from general practitioners for example). This health data is stored in databases. Moreover, to facilitates bigger research projects, the health data is standardised to a common format so that several different databases can participate with their data (that shares the common format). In Europe, there are around 200 databases of health records with standardised data, this database is one of them. Yet, it is still difficult to perform pregnancy research in this standardised data because the standardised format does not allow to include specific information on pregnancy. Therefore, an algorithm to extract pregnancy information from the standardised data is used. This algorithm was developed using standardised health data from the USA and the UK and found to work well. Yet, the algorithm was updated without subsequent testing. Thus, we aim to test the updated algorithm in this data and compare the results with previously published information in the UK. Moreover, we aim to improve the algorithm by incorporating strategies from other published pregnancy algorithms in the UK.
Technical SummaryThe observational medical outcomes partnership (OMOP) common data model (CDM) has worldwide 500 databases who have mapped their real-world data to a standardised format. In Europe, there are around 200 databases. Standardisation to the OMOP CDM has led to reliable and robust health related evidence on various research topics in a timely fashion. Yet, perinatal research is still limited due to lack of a standardised representation of pregnancy information in the OMOP CDM. In a previous project, together with external collaborators, we have developed a standardised format for data on pregnancy and resulting newborns in the OMOP CDM. This standardised format can be easily applied by databases that have information from a pregnancy register. Yet, all others must rely on an algorithm that extracts the pregnancy episodes from the health information in the database. The algorithm was developed and validated in OMOP data from three US-based claims databases and CPRD GOLD. Yet, the algorithm was updated with more concept codes without subsequent validation. Thus, we aim to test this algorithm anew in CPRD patient data. We will compare the number of identified pregnant women, pregnancy outcomes, and gestational length with previously published work in CPRD. Moreover, we aim to manually validate 50 pregnancies per pregnancy outcome that the algorithm produced (as performed in the original validation). Finally, we aim to improve the algorithm by using the mapped concepts of other published work in CPRD/UK and/or change the number of concepts required in an iterative process. Our work will enable the contribution of CPRD data to large-scale European network analyses in health data research in pregnant women.
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Adverse Drug Events in Ageing Populations (ADDRESS-AP): A prediction modelling and causal inference study examining the association between stopping medications and adverse drug events in high-risk patients — James Sheppard ...
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Adverse Drug Events in Ageing Populations (ADDRESS-AP): A prediction modelling and causal inference study examining the association between stopping medications and adverse drug events in high-risk patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-17
Organisations:
James Sheppard - Chief Investigator - University of Oxford
James Sheppard - Corresponding Applicant - University of Oxford
Amitava Banerjee - Collaborator - University College London ( UCL )
Andrew Clegg - Collaborator - University of Leeds
Anna Seeley - Collaborator - University of Oxford
Ariel Wang - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
David Clifton - Collaborator - University of Oxford
Innocent Erone - Collaborator - University of Oxford
Katy Horder - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Richard McManus - Collaborator - Brighton and Sussex Medical School
Richard Stevens - Collaborator - University of Oxford
Rik van der Veen - Collaborator - University of Oxford
Sarah Pendlebury - Collaborator - University of Oxford
Tingting Zhu - Collaborator - University of OxfordOutcomes:
Work package 1: Delirium (primary outcome); syncope and falls; bleeds; renal failure; liver dysfunction; hypoglycaemia and any adverse event (composite outcome).
Work package 2: Delirium (primary outcome); syncope and falls; bleeds; renal failure; liver dysfunction; hypoglycaemia and any adverse event (composite outcome).
Work package 3: Delirium (primary outcome); syncope and falls; bleeds; renal failure; liver dysfunction; hypoglycaemia; any adverse event (composite outcome); subsequent prescribing; all-cause hospitalisation; all-cause mortality; cardiovascular disease; dementia; other outcomes associated with prescribing/deprescribing medications potentially associated with harms in work package 2. Where appropriate, a further 10 positive and negative control outcomes will also be examined.Description: Lay Summary
Older people may have several health conditions and can be prescribed many different medications. Taking too many medications can increase the chance of side effects, such as suddenly feeling unwell and confused (called delirium) or falling. This type of medication related harm is the cause of 1 in 10 hospital admissions. At the moment, doctors are asked to undertake regular medication reviews to avoid these harms, but often do not know which patients are most likely to experience them. One suggestion is to stop prescribing medications which might cause harm, but this approach has not been tested in clinical studies and so doctors do not know what will happen if they try it.
In this project, we will use information from millions of patientâs GP records to see if there is a link between medications and harms such as delirium and falls. We will use statistical methods and artificial intelligence to help find new connections between medications and harms that haven't been uncovered before. We will then create a tool which can predict who is most likely to experience these harms.
Next, we will look at what happens when people receive a medication review and stop taking their medications. We will first compare those who receive a medication review to those who do not, and then in those who had a review, we will look at whether those who stopped medications experienced more or less side effects as a result of this.
Technical SummaryAs individuals age, they often develop multiple health conditions that necessitate the prescription of numerous medications. This is associated with an increased risk of harm, including delirium, falls, bleeding and kidney failure. Although doctors undertake regular medication reviews, they do not always know which patients are most susceptible to experiencing such harms. One solution is to âdeprescribeâ medications, but outcomes of this approach remain unclear.
Aims
1. Discover which medications are most strongly associated with adverse drug events
2. Predict which patients are at the highest risk of adverse drug events
3. Explore the effects of having a medication review and deprescribing medicationsStudy population
Individuals aged â¥65 years in England in CPRD GOLD or Aurum, prescribed at least one chronic medication (from BNF chapters 1 to 13) between 1/10/2006 and 30/09/2023.Statistical methods
Work-package 1 will examine the association between prescribed medication and adverse drug events using multivariable Cox regression, random forests and neural networks to find new associations between medication changes over time and adverse drug events.Work-package 2 will develop (in GOLD) and externally validate (in Aurum) clinical prediction models using a Fine-Gray sub-distribution hazard model, to predict which individuals are at the highest risk of developing adverse drug events, whilst taking into account the competing risk of death.
Work-package 3 will examine outcomes in patients (a) receiving medication reviews verses those who did not and (b) those who had medications discontinued versus those who did not. Analyses will be undertaken using Cox regression, adjusted by large scale propensity scores. A large number of exposures, outcomes and analytical methods will be explored using a rigorous, pre-specified and transparent approach.
These findings will inform policy on the implementation of structured medication reviews, and aid GPs and pharmacists in making evidence-based decisions about prescribing and deprescribing in ageing populations.
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Defining cardiovascular frailty phenotypes and estimating clinical outcomes and healthcare costs in ageing populations — Jane Masoli ...
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Defining cardiovascular frailty phenotypes and estimating clinical outcomes and healthcare costs in ageing populations
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-29
Organisations:
Jane Masoli - Chief Investigator - University of Exeter
SANDRA ARAVIND AREEKAL - Corresponding Applicant - University of Exeter
Anneka Mitchell - Collaborator - University of Exeter
Deniz Turkmen - Collaborator - University of Exeter
Joao Delgado - Collaborator - University of Exeter
Laura Güdemann - Collaborator - University of Exeter
Nicholas Aveyard - Collaborator - University of Exeter
Olivia Murrin - Collaborator - University of Exeter
Osei Asibey Owusu - Collaborator - University of Exeter
Rhian Hopkins - Collaborator - University of ExeterOutcomes:
Outcomes will be examined separately with specific aims in each WP.
Primary Outcomes: Frailty (eFI/eFI change); Adverse cardiovascular outcomes (Major adverse cardiac events (MACE) (acute myocardial infarction(AMI), stroke, cardiovascular mortality, unstable angina, heart failure) as composite and individual components, Atrial fibrillation(AF); Vascular dementia);
Injurious falls; fragility fractures.Secondary outcomes: All-cause Hospitalisation; Length of stay; All-cause mortality; Social-care outcomes( Activities of Daily Living; Care-home admission; Social vulnerability; Mobility and transfer problems, Requirement of care); Medication outcomes ((de)prescriptions, counts (including polypharmacy), potentially inappropriate prescribing); Additional ageing outcomes (delirium, dementia, continence; comorbidity counts ); Primary and hospital care service use and associated costs
Description: Lay Summary
Cardiovascular diseases, such as heart conditions or high blood pressure, are common as people get older. Most research has focussed on younger people or people without other health conditions. Our research has shown that blood pressure starts to fall in some groups of people as they get older â even if theyâve had high blood pressure in the past. We think that changes in blood pressure might also be linked to other changes in cardiovascular health and that this might be a useful early sign of frailty. Frailty makes it harder to get better after being ill and picking up early signs could help to understand how to keep people healthier for longer.
Technical Summary
We will use routine health data from the CPRD to explore the idea of âcardiovascular frailtyâ. We will test links between cardiovascular disease, blood pressure, and frailty and then evaluate whether cardiovascular frailty helps to tell which people might be at risk of serious outcomes. The outcomes weâre interested in include cardiovascular outcomes such as heart attacks and stroke, but also worsening frailty, falls, broken bones and disability.
We hope that understanding cardiovascular frailty could guide a more personalised understanding of risk in people that havenât been well researched before, including people with dementia or in care homes. This research on cardiovascular frailty could inform trials to guide treatment decisions, informing person centred decision making that maximises benefit and reduces risk of side effects.Background: Frailty is a multi-system disorder characterised by depleting functional reserves, increased vulnerability to stressors, and homeostasis disruption. We hypothesise that cardiovascular frailty (CVF) phenotypes can be characterised by dysregulated blood pressure(BP) and impaired homeostasis. We aim to study BP homeostasis components (see below), cardiovascular disease and frailty to define CVF phenotypes and analyse the associations between CVF phenotypes with clinical outcomes and treatment decisions. This will inform future research towards personalised approaches in clinical management of cardiovascular frailty. The objectives and methods will be delivered in three work packages(WP).
WP1: Defining CVF phenotypes
A) Measuring BP homeostasis and cardiovascular frailty
Aims: Develop measures of BP dysregulation/cardiovascular frailty (e.g., BP trends, postural hypotension, systolic BP (SBP), atrial fibrillation(AF)), measure their prevalence and test associations with adverse outcomes (e.g., cardiovascular diseases, mortality, falls, ageing, social/cognitive outcomes)
Methods: Characterize cardiovascular frailty via classification algorithms and statistical models (e.g., non-linear mixed-effects). Survival models will test time-to-event associations, and negative binomial models for count data (e.g., hospitalizations).B) Defining and validating CVF phenotypes
Aim: Defining CVF phenotypes and sub-phenotypes based on the components of BP homeostasis and prevalent cardiovascular disease (eg.AF), hypothesizing that their co-existence may inform CVF phenotype development.
Methods: Linear regression, Random-forest, Cox-proportional risk hazardsWP2: Diagnostic/Prognostic measures based on CVF phenotypes
Aim: Estimate the association between the CVF phenotypes and outcomes (including cardiovascular (atrial fibrillation, heart failure), falls, mortality, social and cognitive outcomes).
Methods: Survival and regression models, and exploratory analyses using machine learning (e.g., elastic net Cox model, Random forests, Boosted trees, neural networks)WP3: Treatment measures based on CVF phenotypes
Aim: Understanding the association of the novel CVF phenotypes with treatment decisions, healthcare costs and treatment effects in ageing populations.
Methods: Linear/logistic regression, Cox-proportional hazards, and method to control for potential confounding, propensity score matching and inverse probability weighting.
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The Impact of Serum Potassium Levels on Dementia Risk: A Cohort Study Using Linked UK Health Data — Benjamin Heywood ...
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The Impact of Serum Potassium Levels on Dementia Risk: A Cohort Study Using Linked UK Health Data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-08
Organisations:
Benjamin Heywood - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient characteristics, SK levels and co-morbidities at baseline; clinical outcomes: Dementia/Cognitive decline/Dementia medication/Dementia subgroups
Description: Lay Summary
Dementia refers to conditions related to loss of memory, problem-solving and language. The most common cause of dementia is Alzheimerâs disease. It is estimated that around 55 million people worldwide have dementia, with 10 million new cases being diagnosed each year. In the UK, there are just under 1 million people estimated to be currently living with dementia.
Recent studies into dementia prevention have suggested that low levels of potassium are related to an increased risk of dementia development. Potassium is an important mineral that helps maintain a healthy brain and nerve function. This study aims to investigate this relationship in greater detail by exploring whether abnormal potassium levels are linked to higher dementia risk.
In this study, we want to use the Clinical Practice Research Datalink to select patients who have had their potassium levels recorded by their general practitioner and examine whether these potassium levels are related to the risk of developing dementia and symptoms of dementia. This will take into account the age of the patients when their potassium level was recorded and other factors that may influence the risk of dementia.
By completing this investigation, we aim to improve the understanding of dementia risk factors and potentially help inform earlier opportunities for diagnosis.
Technical SummaryDementia is a term used for several diseases that affect memory, thinking and other day-to-day activities. Over time, these diseases cause damage to nerve cells and the brain, which leads to cognitive function deterioration. The prevalence of dementia is estimated as 1.4% in the UK, increasing to 7.7% in those aged 65 or above. Serum potassium (SK) is an important mineral that helps maintain a healthy brain and nerve function, yet limited research around the relationship between SK levels and dementia outcomes exists, especially in a UK setting. This study aims to investigate this relationship in greater detail by exploring whether abnormal potassium levels are linked to higher dementia risk.
Patients of acceptable research quality will be selected from the CPRD Aurum and linked Hospital Episode Statistics and Office of National Statistics mortality datasets if they had an SK measurement recorded between January 2004 and March 2023. The index date will be set as the date of first measurement in the study period, and patients will be followed until the earliest of the patientâs transfer-out date, date of death (if applicable), and the last data-collection date for their practice. Patients will be required to have no recorded history of study outcomes, and a 365-day wash-in before SK. Endpoints of interest will include dementia, specific subtypes of dementia, cognitive decline, and dementia-related medications. These will be analysed and presented using KaplanâMeier analysis and Cox regression models. A time-dependent GEE model will then be made to account for SK changes over time. An additional analysis looking at patients diagnosed with hypokalemia will be propensity score matched against the general population to compare rates of dementia-related outcomes.
This study will enhance understanding of SKâs role in dementia risk and may help inform early intervention opportunities, improving long-term outcomes for at-risk populations.
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Clinical management and disease outcomes of patients with pulmonary fibrosis in England — Caoimhe Rice ...
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Clinical management and disease outcomes of patients with pulmonary fibrosis in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-15
Organisations:
Caoimhe Rice - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
- Corresponding Applicant -
- Collaborator -
Adrian Rabe - Collaborator - Imperial College London
Aishwarrya Balaji - Collaborator - Boehringer Ingelheim Ltd
Barbara Torlinska - Collaborator - Boehringer Ingelheim Limited
Javier Cid - Collaborator - Evidera Ltd - UK
Jennifer Quint - Collaborator - Imperial College London
Lourdes Rodriguez - Collaborator - Boehringer Ingelheim Ltd
Rebecca Joseph - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Richard Moore - Collaborator - Boehringer-Ingelheim International GmbH
Robert Donaldson - Collaborator - Evidera Ltd - UKOutcomes:
Number of patients by treatments and lines of therapy; complications of IPF/PPF including mortality; lung function decline; suspected exacerbations; myocardial infarction (MI); pulmonary hypertension; heart failure; sepsis; recurrent pneumonia; COPD; type 1 respiratory failure; lung cancer; diarrhea. HCRU and direct medical costs of primary and secondary care; indirect costs to the patient in terms of productivity loss and loss of future income.
Description: Lay Summary
Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are serious lung diseases that cause lung scarring. IPF has no known cause, while PPF occurs for lots of reasons, including when lung and underlying diseases reach advanced stages, making it difficult to find in medical data. These diseases cause breathing problems that worsen over time and limit daily life. On average, patients die around 4 years after diagnosis.
This study will use anonymous GP and hospital records from England to understand treatments, and common problems for patients with IPF or PPF. We will describe how these lung diseases worsen over time, and when serious events like death happen. We will also examine patientsâ contacts with their doctors and nurses between the start of symptoms and getting diagnosed. We will describe the costs of medical care as well as the cost to patients due to time off work or lost income because of long-term unemployment or early death.
A key challenge in studying rare, complex diseases is the lack of specific diagnosis codes in GP and hospital records, particularly for PPF which is the end-stage of various diseases. We will use signs that suggest the disease has worsened to find patients with PPF e.g., need for oxygen when walking.
The results of our study will increase understanding of the impact of these lung diseases on peopleâs lives and the healthcare system in England, to guide possible improvements and standardisation of patient care and improve the well-being of people with these diseases.
Technical SummaryIPF and PPF are forms of interstitial lung disease (ILD). IPF is a well-characterised chronic, progressive, fibrotic lung disease of unknown cause. PPF is the progressed state of non-IPF ILD, a group of ILDs with heterogeneous aetiologies that can include systemic autoimmune diseases. PPF is characterised by worsening respiratory symptoms e.g., dyspnoea and dry cough, along with physiological and radiological signs of disease progression. This complexity makes it challenging to positively identify based on diagnoses codes and requires a pragmatic approach to define a population of those who progress. With limited treatment options, both IPF and PPF have poor prognoses; median survival time from disease progression is approximately 3.7 years.
In this retrospective cohort study, we will use primary and secondary care data from Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics (HES), Diagnostic Imaging Dataset (DIDS), Index of Multiple Deprivation (IMD), and Office for National Statistics (ONS) to investigate the epidemiology, treatment, health outcomes, and healthcare costs associated with IPF and PPF.
We will establish an algorithm for recognising patients with PPF based on feasible and available data in CPRD-HES. We will describe the characteristics of patients with IPF and PPF. Patient organizations report that misdiagnosis is common in the early stages of these diseases, often delaying a definitive diagnosis, therefore we will assess the clinical pathway from initial symptoms to diagnosis. We will describe treatment patterns, if feasible. We will report the number of patients with each clinical outcome (e.g. mortality, lung function decline). We will assess mortality using survival analysis. We may model rates of lung function decline, exacerbations, and hospitalisation using generalised linear models. We will quantify direct and indirect healthcare resource use and costs.
These results will guide possible improvements in patient care and the well-being of people with IPF and PPF.
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Characterization of neurodevelopmental disorders in children exposed or unexposed in utero to valproate and(or) other antiepileptic drugs with long-term follow-up: retrospective study — Anne Broe ...
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Characterization of neurodevelopmental disorders in children exposed or unexposed in utero to valproate and(or) other antiepileptic drugs with long-term follow-up: retrospective study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2025-01-22
Organisations:
Anne Broe - Chief Investigator - IQVIA Ltd ( UK )
Ella Baird - Corresponding Applicant - IQVIA Ltd ( UK )
Eduardo Ribeiro - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Ella Baird - Collaborator - IQVIA Ltd ( UK )
Georgios Georgakis - Collaborator - IQVIA Hellas Technology Solutions S.A.
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Kieran Brooks - Collaborator - IQVIA Ltd ( UK )
laura ceriani - Collaborator - IMS Health Sweden AB
Mariana Fernandes - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Sandra Godinho Silva - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDAOutcomes:
The primary outcomes of interest for this study are:
Neurodevelopmental disorders (autism spectrum disorder [ASD], attention deficit hyperactivity disorder [ADHD], intellectual disabilities [ID], communication disabilities [CD], disorders of psychological development [DPD], movement disorders [MD]) â as a composite and as specific outcomes.The secondary outcomes of interest for this study are:
NDD pharmacotherapeutic treatments (frequency of changes in NDD treatments [among risperidone, methylphenidate, dexmethylphenidate, amphetamine, dexamphetamine, atomoxetine]);
Health care resource use (HCRU) (hospital admissions [all types], GP visits, ambulatory care visits, paramedical therapies [orthoptist, speech-language pathologist, psychological and physiological therapies], prescriptions);The exploratory outcomes of interest for this study are:
NDD patient pathway (time intervals between consecutive NDD-related events: NDD diagnoses [within class], hospitalisations [all types], ambulatory care visits [all types], paramedical therapies [orthoptist, speech-language pathologist, psychological and physiological therapies]);
Minor congenital malformations (eye, ear/face/neck, heart, respiratory system, digestive system, urinary system, genital organs, limb, chromosomal abnormalities, musculoskeletal system, skin)Description: Lay Summary
Valproate is a drug used to treat epilepsy and bipolar disorder. However, when used during pregnancy, it has been shown to increase the risk of major birth defects in children. Use of valproate during pregnancy has also been linked to developmental disabilities (DDs) in children, including autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disabilities, disorders of psychological development, movement disorders, and communication disabilities. However, the association between valproate and DDs is not yet well understood, and currently available evidence varies in terms of quality, geography, and length of observation of affected children.
This study aims to evaluate the risk of DDs in children born in England between 2004 and 2011 who were exposed to valproate during pregnancy. For comparison, the risk of DDs will also be evaluated for children exposed to other anti-epileptic drugs (AEDs) during pregnancy, and for children whose mothers did not take any AEDs during pregnancy over the same time period. The study also aims to understand the characteristics of children who were exposed to valproate and other AEDs during pregnancy, the treatments received for DDs and other interactions with the healthcare system throughout their childhood, and the characteristics of the childrenâs mothers. Finally, the study aims to evaluate the risk of minor birth defects in children exposed to valproate during pregnancy. The results of this study in England will contribute to a larger study of nine European countries, to better understand and increase awareness of the risks of DDs associated with valproate exposure during pregnancy.
Technical SummaryValproate is used to treat epilepsy and bipolar disorder. When used during pregnancy, it has been linked to neurodevelopmental disorders (NDDs) in children, including autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disabilities, disorders of psychological development, movement disorders, and communication disabilities. However, this association is not yet well understood.
This is a non-interventional longitudinal population-based cohort study of children in England born between 2004 and 2011, using secondary data derived from CPRD linked to HES. The primary aim of this study is to evaluate the incidence rate of first diagnosis of NDD (overall and by sub-type) in children up to 17 years old who were exposed in utero to valproate in monotherapy, and to estimate the relative risk (RR) compared to in utero exposure to lamotrigine or levetiracetam in monotherapy (two anti-epileptic drugs [AEDs] which are considered relatively safe for use during pregnancy) using Cox proportional hazards regression with inverse probability weighting. In secondary objectives, RR of exposure to valproate in polytherapy will be compared to exposure to other AEDs in polytherapy. In exploratory objectives, exposure to valproate will be compared to exposure to 13 other common AEDs individually.
Further analyses will describe: child and maternal demographic and clinical characteristics of children exposed in utero to valproate, including those subsequently diagnosed with NDD; NDD characteristics and course, treatments received, and health care resource use (HCRU) outcomes among children exposed to valproate who were subsequently diagnosed with NDD. Analysis will also describe child and maternal characteristics and the rate of minor congenital malformations (mCMs) among children exposed in utero to valproate.
This research will benefit the public health of patients in England by allowing a more comprehensive understanding of the long-term effects on NDDs of in utero exposure to valproate and other AEDs.
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ID-434-1: Extension: High Intensity Users Scoring Algorithm (additional user) — Imperial College Healthcare NHS Trust...
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ID-434-1: Extension: High Intensity Users Scoring Algorithm (additional user)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: HIU.
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ID-464-2: Networked Data Lab: Topic 6 – Exploring the impact of living with damp & mould / in fuel poverty on adverse health outcomes, healthcare resource usage and costs across NWL — Imperial College Health Partners...
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ID-464-2: Networked Data Lab: Topic 6 – Exploring the impact of living with damp & mould / in fuel poverty on adverse health outcomes, healthcare resource usage and costs across NWL
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Damp & Mould. Commercial
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ID-503: Electronic Health Record Analysis and Longitudinal Data Analysis to understand the risk ractors in dementia — Imperial College NHS Healthcare Trust...
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ID-503: Electronic Health Record Analysis and Longitudinal Data Analysis to understand the risk ractors in dementia
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: dementia.
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ID-294-3: Extension: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment — London Borough of Hounslow...
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ID-294-3: Extension: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: London Borough of Hounslow.
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ID-442: Validation of Risk Models and Patient Triage NWL data — Imperial College Healthcare NHS Trust...
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ID-442: Validation of Risk Models and Patient Triage NWL data
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: missing. Commercial
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ID-444: How are the health and social care costs of neurodegenerative diseases including dementia, multiple sclerosis, Parkinson’s disease, Huntington’s disease and motor neurone disease) impacted by inequality and ethnicity? — University College London...
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ID-444: How are the health and social care costs of neurodegenerative diseases including dementia, multiple sclerosis, Parkinson’s disease, Huntington’s disease and motor neurone disease) impacted by inequality and ethnicity?
Legal basis:research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: University College London
Description: Neurodegenerative diseases.
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ID-443: Targeted Support Hospital Link Worker — London Borough of Hounslow...
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ID-443: Targeted Support Hospital Link Worker
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: London Borough of Hounslow.
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ID-483-1: using a whole systems data approach to monitor the changing health care burden of childhood bronchiolitis following introduction of RSV prophylaxis in Northwest London: a large linked clinical data study — Imperial College Healthcare NHS Trust...
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ID-483-1: using a whole systems data approach to monitor the changing health care burden of childhood bronchiolitis following introduction of RSV prophylaxis in Northwest London: a large linked clinical data study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: bronchiolitis.
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ID-327-7: ICHP Feasibility Searches — Imperial College Health Partners...
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ID-327-7: ICHP Feasibility Searches
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Feasibility Searches.
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ID-467-1: Evaluating the Impact of Virtual Care on the Safety and Efficacy of Diabetic Pregnancy Management in North West London — Imperial College London...
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ID-467-1: Evaluating the Impact of Virtual Care on the Safety and Efficacy of Diabetic Pregnancy Management in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Diabetes.
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ID-414-1: Extension: Veterans Physical Health Needs Assessment — Imperial College London...
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ID-414-1: Extension: Veterans Physical Health Needs Assessment
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Veterans.
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ID-501: climate and pollution impacts on health WCC and RBKC — Westminster City Council...
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ID-501: climate and pollution impacts on health WCC and RBKC
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: climate and pollution.
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ID-439-1: Making the economic case for remote glucose monitoring during chemotherapy — Chelsea and Westminster NHS Foundation Trust...
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ID-439-1: Making the economic case for remote glucose monitoring during chemotherapy
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-25
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster NHS Foundation Trust
Description: Chemotherapy.
Source
2024 - 12
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— unknown...
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Where: unstated
When: 2024-12-9
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding two Research Fellows to conduct policy-relevant research using the Data First: Cross-Justice System - England and Wales dataset, a groundbreaking resource that links Ministry of Justice data from the civil and family courts with criminal justice system data. These form part of ADR UKâs fellowship opportunities which invited applications to carry out research using eligible flagship datasets.
This dataset contains de-identified data on an individual person- and case- level, from the start of criminal prosecutions in the magistratesâ courts and Crown Court, through to periods spent in prison custody or under supervision of the Probation Service. This data is now linkable to information on adults and children involved in family court cases dealing with child arrangements, divorce, or adoption, as well as people (and companies) involved in civil cases, for example, in relation to housing or debt, as claimants or defendants.
The Data First: Cross-Justice System dataset therefore offers a unique opportunity to explore how people experience and interact across different justice jurisdictions, from criminal prosecutions to civil and family court cases. These can provide insights into research questions that have not been possible before, such as to what extent people involved in the criminal justice system are also dealing with cases in relation to children, housing or debt in the civil and family courts.
By studying these patterns, research using the dataset can help to build a picture of how justice system interactions can shape broader social outcomes. These Research Fellows are using the linked criminal justice data in this dataset to explore ethnic inequalities, reoffending and offender rehabilitation. They will access the dataset via the Office for National Statistics (ONS) Secure Research Service.
Learn more about the Research Fellows and their projects below.
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Patient characteristics, healthcare resource use and costs in primary and secondary care among adult patients with RSV in England — Rebecca Butfield ...
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Patient characteristics, healthcare resource use and costs in primary and secondary care among adult patients with RSV in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-05
Organisations:
Rebecca Butfield - Chief Investigator - Pfizer Inc - US Headquarters
Thomas Jennison - Corresponding Applicant - Adelphi Real World
Antonia Geneidat - Collaborator - Adelphi Real World
Carmen Hockey - Collaborator - Pfizer Ltd - UK
Dexter Wiseman - Collaborator - Imperial College London
Eddy Tye - Collaborator - Pfizer Ltd - UK
Ella Knight - Collaborator - Pfizer Ltd - UK
Isabel Jimenez - Collaborator - Adelphi Real World
Jack Said - Collaborator - Pfizer Ltd - UK
Jon Watkins - Collaborator - Adelphi Real World
Kiran Rai - Collaborator - Adelphi Real World
Poppy Payne - Collaborator - Adelphi Real WorldOutcomes:
All-cause and RSV related healthcare resource use (primary care consultations, inpatient hospitalisations, critical care admissions, critical care interventions, mechanical ventilation, prescriptions written in primary care, outpatient specialist encounters); all-cause and RSV-related healthcare costs (by care setting and total); sociodemographic and clinical characteristics; all-cause and RSV-related mortality.
Description: Lay Summary
Respiratory syncytial virus (RSV) can cause respiratory infections, often leading to cold-like symptoms, and in some cases, severe complications including pneumonia and bronchitis. Estimates suggest 71 hospital admissions per 100,000 adults aged 65-74 are accountable to RSV in the UK, rising to 251 admissions over 75 years, attributing to ~8,500 deaths among adults during peak RSV season.
Patients tend to present symptoms within 4-6 days of infection, recovering fully within 1-2 weeks. However, those who are elderly, have a weakened immune system, or have chronic conditions are at greater risk of hospitalisation and longer recovery times. Whilst diagnostic testing is key to confirm RSV, infrequent testing in general practitioner (GP) practices and hospitals often leads to an underestimation of RSV cases, and consequently an underestimation of the economic burden to the National Health Service.
Currently, little research has been conducted to assess RSV burden on healthcare resources and associated costs amongst adults in the UK. Through this study, we aim to address these research gaps by describing the impact of RSV on patients and the healthcare system, describe the characteristics of patients with RSV, and determine the number of people who become hospitalised or die as a result. We will also explore further by age, patient risk of severe disease and those residing within care homes to better understand patients that may present greater disease burden. The findings from this study will be used to inform healthcare policy and future research into targeted interventions for those with RSV.
Technical SummaryAim:
To describe healthcare resource use (HCRU) and associated costs, patient characteristics and mortality amongst adults aged â¥18 years with a Respiratory Syncytial Virus (RSV) infection in England.Objectives:
To i) describe HCRU/costs per RSV episode and acute phase; ii) describe baseline sociodemographic and clinical characteristics; iii) estimate case fatality; iv) describe HCRU/costs and estimate mortality during the long-term RSV phase.
Objectives will be stratified by age, patient groups at risk of severe RSV and care home residence prior to index. Results will be reported in hospitalised and primary care cohorts separately.Methods:
Retrospective cohort study of adults with a specific or possible RSV diagnosis between 1st October 2014 and 31st March 2019 using linked primary care (CPRD Aurum) and secondary care (HES-APC) data. Minimum 12-monthsâ data pre-index is required, with a minimum of 30-days follow-up. Episodes where there is confirmed diagnoses for a respiratory infection or a specific/possible RSV diagnosis 30-days prior to index will be excluded.Exposures:
RSV Episode (RSV-specific/RSV-possible); episodes â¥90 days apart will be considered as separate episodes (i.e., infections).
Outcomes:
All-cause and RSV-related HCRU and costs (primary care consultations, inpatient stays, critical care admissions/interventions, mechanical ventilation, readmissions, medications prescribed in primary care, outpatient specialist encounters), baseline sociodemographic and clinical characteristics, and all-cause and RSV-related mortality.Data analysis:
Counts, mean, standard deviation, medians, interquartile range and minimum/maximum values will be reported for numeric variables, frequencies and proportions for categorical variables. Rates will be calculated by dividing frequency of events by person time at-risk.Public benefit:
HCRU and mortality for RSV infection amongst adult patients will be reported by age, risk of severe disease and those residing within care homes. Care disparities may be found, providing evidence to optimise care management, resource allocation and the assessment of various vaccination strategies.
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Modelling the impact of prevention on demand for NHS services for cardiovascular disease (CVD) — Jonathan Wray ...
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Modelling the impact of prevention on demand for NHS services for cardiovascular disease (CVD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-10
Organisations:
Jonathan Wray - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Robert Willans - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Alfredo Mariani - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Prevalence of all listed CVD conditions, and T2DM and renal failure. Estimates for future prevalence over 1,5 and 10 years.
Healthcare utilisation metrics: primary care consultations (stratified by healthcare professional and location), inpatient appointments (elective, elective day case, emergency), Outpatient appointments, A&E attendances, Ambulance call-outs, access to rehabilitation services, accessing diagnostic imaging services post diagnosis, length of inpatient stay, waiting times.
Demographics stratifications; age, ethnicity, IMD.Some of the above outcomes are exploratory (e.g. wait times, rehabilitation service usage) and will only be reported if data quality or completeness is deemed appropriate.
Description: Lay Summary
This research will look at how often people use NHS services after they have been diagnosed with cardiovascular disease, a group of conditions that affect the heart and blood vessels. This includes conditions such as heart attacks and strokes, where blood stops flowing to a part of your brain. The research will also look at how many people in England are living with cardiovascular disease, and how this might change in the future. This will improve our understanding of what impact cardiovascular disease has on the NHS. This work forms part of a wider project to understand how use of the NHS might change if we focused more on preventing disease rather than just treating it when it happens.
We will look at what NHS services people need to use once they have been diagnosed with cardiovascular disease. This includes things like how many GP and hospital appointments they have, how often they go to A&E (accident and emergency) and how long they need to stay in hospital for. We will look at how this might be different depending on the number or type of conditions the person has, or if it also depends on personal characteristics such as age, ethnicity and deprivation.
This analysis is important as before we can understand the impact of preventative activities, we need to know what is happening now. In the long term we hope this might result in less people being diagnosed with life changing conditions and reduce the impact on NHS services.
Technical SummaryThere is a lack of evidence on how action on prevention could impact demand for NHS services. To further our understanding, we require a detailed understanding of the current situation. Data from CPRD will be used to describe use of NHS resources following a CVD event/diagnosis, considering the full patient pathway and different patient demographics.
A cohort of patients with at least one CVD diagnosis/event, including Coronary Heart Disease (CHD), Myocardial Infarction (MI), Atrial Fibrillation (AF), angina, ischaemic stroke, Transient Ischaemic Attack (TIA) or chronic heart failure will be selected. In addition, patients with a diagnosis of Type 2 Diabetes and renal failure will be included, due to common risk factors and frequency of comorbidity. Data will describe NHS resource usage in the year prior to diagnosis and 1, 5 and 10 years after, including:
1) Primary care usage:
a. Count of primary care consultations
b. Proportion of primary care consultations delivered by GPs, nurses, and other healthcare professionals
c. Proportion of primary care consultations delivered in person, remotely and via home visit.
2) Secondary care usage:
a. Count of inpatient appointments
b. Outpatient attendances
c. Length of Stay (days)
d. A&E attendances
e. Ambulance call-outs
f. Usage of rehabilitation services
g. Waiting times
Analyses will be stratified by patient demographics, comprising age group, ethnicity and Index of Multiple Deprivation (IMD) quintiles. Additionally co- and multi- morbidity will be examined for patients with 2+ and 3+ CVD diagnoses and/or Type 2 Diabetes or renal failure.In addition, CPRD data will be used to calculate the prevalence of included conditions across people in England and expected change over time (1 year, 5 year and 10 year) based on simple linear predictive models. This work will benefit patients by contextualising the potential of pursuing a more ambitious approach to preventative medicine.
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Trends and patterns of glucocorticoid use and related adverse outcomes in Giant cell arteritis and polymyalgia rheumatica — James Galloway ...
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Trends and patterns of glucocorticoid use and related adverse outcomes in Giant cell arteritis and polymyalgia rheumatica
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-18
Organisations:
James Galloway - Chief Investigator - King's College London (KCL)
Zijing Yang - Corresponding Applicant - King's College London (KCL)
Edward Alveyn - Collaborator - King's College London (KCL)
Mark Russell - Collaborator - King's College London (KCL)Outcomes:
We defined GC use as any oral prescription (one or more) for the medication as listed in Table S1 in the study sample over the course of the follow-up window (Jan 01 2000 to Jan 01 2024). The timing of each prescription will be established by the date it was issued. Given the variation in relative effects of different glucocorticoids, for each prescription of oral glucocorticoids, we will convert the dosage into milligrams of prednisolone-equivalent dose using conversion factors from Table S1.
Cumulative GC dose was calculated as the sum of all prednisolone (or equivalent) doses (mg) prescribed from the index diagnosis date up until the end of the study period, de-registration, or death, whichever occurred first. Each prescription duration, including the duration of repeat prescriptions, was defined as the quantity of medication divided by the daily dose, reported as median (IQR).
To explore patterns in detail, we will assess glucocorticoid use in dosage, duration, and frequency. We will evaluate other time-variant GC variables to quantify current and cumulative drug exposure: (1) current daily use, relying on BSR tapering suggestion, High-daily-dose GC:40â60 mg/day prednisone-equivalent, Moderate-dose GCs: 10â40 mg/day, Low-dose: 5- 10 mg/day, Negligible-dose: less than 5 mg/day, nonuse; (2) intermittent GC prescriptions, for patients with a single GC prescription (as a proxy for GC use), less frequent pattern, for patients with >1 prescription with any gaps>90âdays but no gap1 prescription with < 90-day gap (15).
The incidence of adverse outcomes was calculated by dividing the number of cases by the number of person-years. The person-years were computed to start at the first GC prescription and stop at the earliest of death, transfer out of practice, practice's last collection date, incidence of the disease of interest, or study end date. The adverse outcomes include osteoporosis, cardiovascular disease, Type 2 diabetes, glaucoma and cataracts. They are defined according to the related diagnosis code.
Description: Lay Summary
Giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) are conditions that mainly affect older adults. They cause symptoms like pain, stiffness, and in some severe cases, vision loss. To manage these conditions, clinicians often prescribe glucocorticoids, a type of medication that reduces inflammation. While glucocorticoids can help control symptoms, using them for a long time with high doses can lead to serious side effects. Our study aims to find out how glucocorticoids are used in treatment. We will look at how these medications are prescribed, including the doses used and the duration of treatment. We also want to see how different use of glucocorticoids is linked to the risk of serious health problems like heart disease. By understanding these patterns and risks, our research will provide more information on how to improve a better management of these conditions, potentially reducing the risk of serious side effects and improving overall patient health.
Technical SummaryThe treatment of choice in GCA and PMR remains to be glucocorticoids (GC), which have been associated with severe treatment-related side effects. Current research lacks comprehensive information on how GC prescribing patterns have evolved over time, especially the regional variations and their real-world impact on patient health outcomes. This research aims to analyze the trends in GC prescribing and evaluate the impact of these medications on key health outcomes, including mortality, cardiovascular events, and diabetes.
The population-based cohort study will calculate the annual prevalence and incidence rates of GC prescriptions, segmented by demographic factors such as age, gender, ethnicity, and socioeconomic status. These metrics will be described using appropriate statistical methods and visualized to illustrate trends and regional variations.
Joinpoint regression analysis will be employed to identify significant changes in GC prescribing patterns over time. This model will help determine when changes in prescribing occurred and quantify the average annual rate of change. Discrete join points, where the trends in prescribing patterns shift, will be identified using a data-driven approach, which allows the model to determine these points objectively based on the data itself.
Additionally, this study will explore the associations between GC use and adverse health outcomes, including cardiovascular events, diabetes, and mortality in GCA and/or PMR. The study will utilize Cox proportional hazards models to examine the relationship between GC dose (both daily and cumulative) and these outcomes, while adjusting for multiple observations per patient and accounting for the competing risk of death. Sensitivity analyses will categorize GC doses into low, medium, and high levels, based on established criteria, to further investigate dose-related risks.
By providing a detailed analysis of GC prescribing trends and their associated health risks, this research aims to inform clinical practices and guide more effective, safer management strategies for patients with GCA and PMR.
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Healthcare demand modelling: investigating changing trends in healthcare use and projections into the future — Toby Watt ...
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Healthcare demand modelling: investigating changing trends in healthcare use and projections into the future
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-17
Organisations:
Toby Watt - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Ann Raymond - Collaborator - The Health Foundation
Chris Kypridemos - Collaborator - University of Liverpool
Jay Hughes - Collaborator - The Health Foundation
Katie Fozzard - Collaborator - The Health Foundation
Laurie Rachet-Jacquet - Collaborator - The Health Foundation
Stephen Rocks - Collaborator - The Health Foundation
Zeyad Issa - Collaborator - The Health FoundationOutcomes:
Incidence, prevalence, fatality, mortality rates for 20 non-communicable diseases (NCDs), Cambridge Multimorbidity Score (Payne et al. (2020)).
NCDs; coronary heart disease, stroke, obstructive pulmonary disease, diabetes mellitus, dementia, asthma, chronic pain, cancer, constipation, hearing loss, irritable bowel syndrome, kidney disease, connective tissue disorders, alcohol problems, heart failure, psychosis/bipolar disorder, epilepsy, anxiety, depression, atrial fibrillation, hypertension.
Attendance numbers:
Outpatient appointments by treatment speciality,
A&E type/treatment
Consultations (Primary Care)Number/type of:
COVID-19 related hospital activities
Prescriptions (Primary Care)Hospitalisation numbers:
Elective; long-stay/day-case
Non-elective (HRG code)Healthcare activity costs (Curtis and Burns (2020), OpenPrescribing.net, National Cost Collection for the NHS, NHS Digital (2023)).
Description: Lay Summary
More people are living longer with long-term conditions such as heart disease or cancer. These illnesses often cannot be cured and require long-term management through health and care services. It is important to understand how demand for the health system is growing and how it may change in the future. This will help to plan future healthcare resource requirements such as Government spending, hospitals as well as doctors, nurses and other health staff.
We aim to expand on previous work projecting health care use and costs from the National Health Service (NHS), improving previous projections by exploring trends since the coronavirus pandemic in new cases of illness and deaths. We will look at how the conditions people have and how they use healthcare services have changed over time, while taking into account patientsâ age, sex, ethnicity, how many conditions they have, and when they were diagnosed. We will use data from the Clinical Practice Research Datalink (CPRD), which is representative of the population of England, linked to hospital records, death registry, with information about deprivation (the education levels, income and health of the population) in patientsâ local areas. Our results, using population projections from the Office for National Statistics, will estimate the total future cost of the NHS. We will also estimate the healthcare activity needed.
This project will help us understand the resources needed to treat a growing population who are living longer with multiple conditions. This improved understanding will support decision-making for policy and funding decisions.
Technical SummaryThe aim of this study is to estimate up-to-date levels of illness, healthcare activity and costs for the English population, accounting for recent events such as the impact of COVID-19 and changes in productivity. We will use these estimates to calculate projections of these measures to understand the extent of the cost and other input pressures facing the National Health Service (NHS) on a national level for future decades. This project will update previous projections based on data from 2008-2019, with more detailed modelling and additional stratification by ethnicity and urban-rural status of patient practice.
We will use a cohort of 6 million participants randomly sampled from the Clinical Practice Research Datalink (CPRD) and linked datasets from 2008 to 2024. We will identify cases of common non-communicable diseases (NCDs) and describe past trends in incidence, prevalence and mortality of individual NCDs and multimorbidity, as well as estimate annual healthcare activity by calculating total annual healthcare costs over primary and secondary care.
We will use generalised additive models for location scale and shape for all statistical modelling, adjusting for year, age, sex, region, ethnicity, rurality, and deprivation. Outputs from these statistical models will inform the parameters of a discrete-time stochastic dynamic microsimulation model. With this, we can simulate the life courses of an English synthetic population. These projections will help better understand how changes in patterns of NCDs may affect the health resources used over the coming 15-30 years.
In short, our work will synthesise the best available real-world evidence to create a microsimulation decision support tool for healthcare policymaking. In consultation with policy, epidemiology and health economics experts, we will continue to provide NHS funding and healthcare activity projections under policy-relevant `what if` scenarios in a timely fashion. Such a microsimulation decision support tool is currently unavailable elsewhere in England.
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Assessing the role of social determinants of health in asthma hospitalisations using the Clinical Practice Research Datalink. — Ireti Adejumo ...
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Assessing the role of social determinants of health in asthma hospitalisations using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-06
Organisations:
Ireti Adejumo - Chief Investigator - University of Nottingham
Ireti Adejumo - Corresponding Applicant - University of Nottingham
Charlotte Bolton - Collaborator - University of Nottingham
Dominick Shaw - Collaborator - University of Leicester
Tricia McKeever - Collaborator - University of NottinghamOutcomes:
Co-primary outcomes:
1. Odds of asthma hospitalisation by Index of Multiple Deprivation (IMD)
2. Odds of asthma hospitalisation by ethnicity.Secondary outcomes:
1. Representativeness of CPRD asthma dataset compared with national Census 2021 data for age, sex, ethnicity and IMD
2. Odds of asthma hospitalisation associated with intersectionality looking at deprivation, ethnicity, age and sex
3. Effect modification of deprivation and ethnicity by body mass index (BMI), Charlson comorbidity index (CCI), anxiety, depression, smoking status, short acting bronchodilator use, inhaled corticosteroid (ICS) use, asthma control step, biologics access, asthma review attendance and burst oral corticosteroid (OCS).Description: Lay Summary
Asthma is a common lung disease which can stop people of all ages leading a full life. One in 12 adults in the United Kingdom (UK) lives with asthma. Research from across the world shows that some people who are less well-off or who are ethnic minorities may be more likely to have an asthma attack than people who are well-off or of White ethnic heritage. Some of this may be caused by unfairness in our society, rather than severe disease.
There is very little UK-based research into how to fix these inequalities. I will use data collected from thousands of people with asthma across England to understand how wealth and race/ethnicity affect peoplesâ risk of ending up in hospital with an asthma attack. I especially want to understand how this impact might link to things that we can treat and change, such as mental health conditions, smoking and medication use.
The results of this project will form the basis of research to find better ways of getting the best asthma care, personalised to the people who need it the most.
Technical SummaryBackground
Asthma is a heterogeneous condition affecting 4.3 million United Kingdom (UK) adults. It can lead to activity limitation, hospitalisation and, rarely, death. Personalised asthma care improves outcomes by addressing clinically relevant, measurable and treatable characteristics.Inequalities in asthma outcomes are well-recognised in the international literature and can be aggravated by societal inequity. This project hypothesises that social determinants are associated with asthma hospitalisations in England, and that this association is partially mediated by factors that can be modified to increase effectiveness of asthma interventions.
Aims and objectives
⢠Aim: Quantify the role of socioeconomic status (SES) and UK-minority ethnicity on asthma hospitalisations in England.
⢠Objectives:
o Assess for associations between SES/UK-minority ethnicity and asthma hospitalisations
o Assess for explanatory variables which may mediate associations.Methods
The Clinical Practice Record Datalink (CPRD) linked to Hospital Episode Statistics (HES) will be used to conduct a case-control study assessing the odds of hospitalisation in people with greater socioeconomic disadvantage or UK-minority ethnicity compared to high SES and White ethnicity respectively. Participants aged 18 years and over will be included where SNOMED codes are consistent with a diagnosis of asthma at least 12 months before the point of study entry. Participants with primary diagnoses of other major respiratory diseases will be excluded.Analyses will be conducted in STATA (StataCorp LLC). Data will be described using summary statistics, with odds ratios used for comparisons. The significance level will be set to 0.05. Regression modelling will be used to assess candidate mediating factors and also assess for confounders.
Impact
It is hoped that this study will highlight population groups that stand to benefit from personalised asthma interventions. Follow-on work will develop such interventions, with a view to reducing disparities in asthma outcomes driven by social determinants of health.
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Medicines prescribed in pregnancy: assessing safety for mother and baby using routinely collected data — Liza Bowen ...
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Medicines prescribed in pregnancy: assessing safety for mother and baby using routinely collected data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-23
Organisations:
Liza Bowen - Chief Investigator - St George's, University of London
Liza Bowen - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Emma Baker - Collaborator - St George's, University of London
Hannah Johnson - Collaborator - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
Joan Morris - Collaborator - St George's, University of London
Michael Perkin - Collaborator - St George's, University of London
Pensee Wu - Collaborator - Keele University
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
a) Prevalence of medication use in pregnancy (by medication category)
b) Maternal outcomes: Maternal medical conditions arising in pregnancy; Maternal delivery complications; Maternal death; Maternal post-partum complications
c) Fetal outcomes: Molar pregnancy; Ectopic pregnancy; Miscarriage; Premature delivery; Stillbirth; Congenital anomaly
d) Infant outcomes: Small-for-gestational-age at delivery; Large-for-gestational-age at delivery; Neonatal death; Infant death; Hospital admissions; Infant medical conditions.Description: Lay Summary
Taking medicines during pregnancy is common and increasing. For many medicines there is not enough research data available to understand whether they are safe or not. This is because pregnant women are often excluded from trials of new medicines.
Technical Summary
In this study we will use health information from pregnant women and their babies that is routinely collected in general practitioner and hospital health records.
1. We will look at how often different medicines are given in pregnancy, whether this has changed over time, and how it varies by region, deprivation, age, ethnicity, and health of the pregnant woman.
2. We will look at which medicines were taken most commonly by pregnant women who then had serious health problems during or after the pregnancy or whose babies had problems. These medicines may not be safe and we will use statistical methods to assess which ones are most likely to be harmful.
3. We will discuss findings with health workers and patients to make a priority list of medicines that we need further information on.
4. We will investigate the safety of the most highly prioritised medicines by looking in detail at which women are taking the medicines and whether the women's existing ill health or other factors may be related to the health problems they or their babies developed.
We will discuss our findings with patients, healthcare workers, and information providers to help improve the safety of pregnancy prescribing and ultimately the health and wellbeing of pregnant women and their babies.Medication use in pregnancy is common, yet the safety to mother and baby of many medications is unknown because pregnant women are often excluded from drug trials. Our aim is to use routine health data to systematically examine all prescribed medications in pregnancy and prioritise which require further research into their potential harms.
Pregnancies, medication use, and maternal and fetal outcomes will be ascertained from linked primary care records, the CPRD pregnancy register and HES data. The occurrence of adverse outcomes in pregnancies exposed to the medication of interest compared to those in pregnancies not exposed to the medication of interest (called measures of disproportionality) will be calculated. Cluster methods will use these measures to define groups of similar medications and similar outcomes. Bayesian hierarchical models will refine these measures of disproportionality by sharing data within the identified groups (for example if several drugs in a group are found to be harmful then other drugs in that group may be more likely to be harmful). For the medication-outcomes pairs found to be statistically significant, data on their frequency of prescription in pregnancy in addition to published scientific evidence of harm or safety will be used to prioritise which of these medications require further research into their potential harms. For selected prioritised medication, a cohort study of the outcomes for women taking the medication will be compared to outcomes for women not taking the medication and confounders such as maternal morbidity and co-medications will be adjusted for using multivariable logistic regression with propensity scores, Lasso regression and multiple imputation where appropriate.
Results will be discussed with UK Teratology Information Service and relevant findings added to bumps (best use of medicines in pregnancy) resources to help improve informed decision making for patients and clinicians.
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Development and external validation of a risk prediction model for asthma attacks in primary care: a retrospective cohort study — Ralph Kwame Akyea ...
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Development and external validation of a risk prediction model for asthma attacks in primary care: a retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-03
Organisations:
Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Amy Chan - Collaborator - University of Auckland
Evangelos Kontopantelis - Collaborator - University of Manchester
Holly Tibble - Collaborator - University of Edinburgh
Kajal Panchal - Collaborator - University of Nottingham
Matthew Martin - Collaborator - Nottingham University Hospitals
Nadeem Qureshi - Collaborator - University of NottinghamOutcomes:
Main outcome measure:
Asthma attack, defined as:
1. a clinical diagnosis (coded) of asthma
2. prescription of oral corticosteroid (OCS), or increase from stable maintenance dose, for â¥3 days with OCS courses separated by â¥1 week considered separate attacks or
3. hospitalisation or emergency department visit due to asthma requiring systemic corticosteroids
4. deaths with asthma listed as primary cause will also be considered asthma attacks
Description: Lay Summary
Asthma is a long-term disease affecting the airways in the lungs and remains a major public health issue in the UK, where poor asthma outcomes are a significant concern. About four people die from asthma attacks every day, and asthma attacks can lead to permanent lung damage. Every year, asthma results in 6.4 million primary care (general practice) visits and 93,000 hospital admissions across the UK, placing a substantial burden on the healthcare system due to the costs associated with emergency and hospital care.
Routinely collected electronic health records offer a unique opportunity to improve asthma care by accurately calculating future asthma risk. Using routinely collected patient records from general practices across the UK, this study aims to develop a tool to help predict asthma attacks.
The findings from this study will support the development of a new computer-based tool that could be added directly into electronic health record systems for general practices. This tool would help healthcare providers assess risk levels for future asthma attacks. This will enable healthcare providers to target treatments and allocate resources effectively to improve patient outcomes, and ease healthcare costs related to asthma care.
Technical SummaryAim: To develop and validate (internally and externally) an asthma attack prediction model to estimate 12-month risk of an asthma attack using well characterised anonymised electronic health records with both machine learning and traditional statistical approaches guided by expert and patient knowledge.
Study Design: Retrospective Open Cohort
Setting: UK Primary care settings
Participants: Patients aged 18 years and over between 1st January 1997 and 31st December 2021 with primary care records (CPRD GOLD and Aurum) linked to hospitalisation records (HES Admitted Patient Care and Accident and Emergency data).
Primary outcome: Asthma attacks (defined below in Main Outcome Measure) in CPRD or HES data.
Methods: Risk factors (candidate predictors) for asthma attacks will be identified from existing literature and stakeholder engagement sessions consisting of panels of asthma patients and specialist consultants. A supervised machine learning approach will be used to assess and rank candidate predictors for asthma attacks informed by the patient and expert panels based on their âimportanceâ from CPRD Aurum data. The most important candidate predictors (those with 10% of the maximum Gini score) identified by machine learning will be discussed with the patient and expert panels to decide on factors most important to include in the final model using established statistical methods of risk model development.
The final regression model using a competing risk model will be internally validated using CPRD Aurum and externally validated using CPRD GOLD dataset. The performance of the model will be assessed in terms of discrimination (predictive accuracy) using Harrellâs C-statistic and the model calibration using calibration slope by plotting agreement between predicted and observed events.
Outputs: Findings from this study will provide the foundation for the development of a new primary care tool for assessing asthma attack risk to target existing preventative treatments to those at highest risk of asthma attacks.
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Mental Health Outcomes and Utilization of Mental Health Care Services in ageing adults in Primary Care — Rathi Ravindrarajah ...
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Mental Health Outcomes and Utilization of Mental Health Care Services in ageing adults in Primary Care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-16
Organisations:
Rathi Ravindrarajah - Chief Investigator - University of Manchester
Rathi Ravindrarajah - Corresponding Applicant - University of Manchester
Alex Dregan - Collaborator - King's College London (KCL)
Carolyn Chew-Graham - Collaborator - Keele University
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Jahanara Miah - Collaborator - University of Manchester
Karina Lovell - Collaborator - University of Manchester
Pearl Mok - Collaborator - University of Manchester
Roger Webb - Collaborator - University of ManchesterOutcomes:
Primary Outcomes: the rates of prescribing for anti-depressant and anti-anxiety drugs; frequency and type of primary care consultation; and the number of referrals to Mental Health Services.
Secondary outcomes: Examine the above variations according to patient, consultation rates, mortality, hospital admissions and general practice characteristics
Description: Lay Summary
There has been a rise in the number of people living longer with long-term conditions, poor mental health, and frailty.
Technical Summary
Older adults are more often prescribed drugs for mental health conditions and less likely to be signposted to talking therapies. Medication needed to treat mental health conditions may have side effects such as increasing the risk of falls in older adults. The COVID-19 pandemic has also had a harmful impact as individuals were asked to socially isolate, increasing loneliness, anxiety, and depression. Health care services were offered remotely via telephone or online, which has also resulted in a change in the way care is provided even post-pandemic. However, access to NHS talking therapies are lower in older adults, accounting for only 5% of their referrals. Hence, it is important to understand whether steps were taken to include these individuals in service delivery.
We will use health care records from patients to explore the treatment and care provided for older adults with depression and anxiety in primary care. We will check the numbers of older adults who were referred and were able to access mental health care and how these vary by age, sex, frailty, alcohol consumption, ethnicity, menopause, social- economic status, and regions across the UK over time.Poor mental health in older adults is often accepted as part of ageing by older adults as well as physicians who treat them and evidence suggests that they are not prioritised for non-pharmacological treatments in primary care. Older adults may be missing out on the benefits of psychological therapy and there are potential harms associated with polypharmacy such as an increased risk of falls. The inequality in accessing mental health care services by older adults has been acknowledged in the NHS long-term plan and the NHS Mental Health Implementation Plan for 2019/20-2023/24 [NHS-MIP].
This project aims to map mental health needs and services accessed by adults aged 50 and over, using primary care electronic health records. The prevalence of depression and anxiety in the cohort will be explored based on age, sex, alcohol consumption, menopause, frailty status, regions, ethnicity, and socio-economic factors at area level. Rates of prescribing patterns for anti-depressants and anxiolytics in the cohort will be calculated by gender and age group over the study period. We will also examine variations in psychotropic prescriptions and the frequency of referrals to mental health services according to patient and practice characteristics. Poisson regression models (or negative binomial model as appropriate) will be used to estimate incidence rates. The study will also examine changes at (1) the individual patient level by comparing referrals and outcomes within individuals diagnosed with depression or anxiety and (2) at the practice-population level using an interrupted time-series (ITS) design to examine changes in referrals and outcomes by the population after the implementation of the NHS-MIP compared to the prior 5-year period.
By mapping the need for and usage of mental health care in older adults, the findings from this research will provide valuable information for health care service planning and providers for future improvements.
Source -
Health service utilisation among pregnant and postnatal women with multiple long-term conditions — Zoe Vowles ...
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Health service utilisation among pregnant and postnatal women with multiple long-term conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-23
Organisations:
Zoe Vowles - Chief Investigator - University of Birmingham
Zoe Vowles - Corresponding Applicant - University of Birmingham
Abigail Easter - Collaborator - King's College London (KCL)
Arturo Gonzalez-Izquierdo - Collaborator - University of Birmingham
Jane Sandall - Collaborator - King's College London (KCL)
Katherine Phillips - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Megha Singh - Collaborator - University of Birmingham
Steven Wambua - Collaborator - University of BirminghamOutcomes:
Health care utilisation in primary and secondary care during the antenatal period and up to twelve
months postpartum, including:
1) primary care consultations,
2) hospital admissions,
3) outpatient attendances,
4) accident and emergency attendances, and
5) utilisation of secondary care mental health services (provided in hospital, community , and outpatient settings).Description: Lay Summary
About 20% of pregnant women in the UK have more than one health problem before they get pregnant. These problems could be things like diabetes (a condition where blood sugar is too high), high blood pressure, anxiety, or depression. These women usually need to go to a lot of different appointments during their pregnancy. Sometimes, their care doesnât work well together, and it can be confusing.
We donât yet know exactly how these women use health services during pregnancy or after they give birth. To find out more, weâll look at the health records of women with more than one health problem. We will check how they use different health services during pregnancy and for a year after they have their baby. We will compare how these women use services to women who don't have long-term health problems.
We will also compare women who have only physical health problems with those who have both physical and mental health problems. This will help us see how many appointments they need to go to and if some women are more likely to visit emergency departments instead of having usual care. Learning this information will help to make care better for women with more than one health problem in the future.
Technical SummaryOne in five pregnant women in the UK have two or more physical or mental health conditions pre-pregnancy (MLTC). They are at higher risk of experiencing treatment burden and adverse pregnancy outcomes. This study, a retrospective cohort study using anonymised research data from Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics secondary care data will explore how pregnant and postnatal women with MLTC use health services and identify any inequalities.
The exposure of MLTC will be defined as having two or more long term physical or mental health conditions that preexisted before pregnancy. This will be operationalised using a list of 79 long-term conditions developed with
patients and clinicians from the MuM-PreDiCT collaborationâs epidemiological work. Women with and without MLTC in England, with a recorded birth in the CPRD and linked HES dataset and at least one year worth of health records available prior to index pregnancy will be included.The association between health care utilisation in primary and secondary care during the antenatal period and up to twelve months postpartum will be explored including: 1) health utilisation among pregnant women with MLTC compared to pregnant women without MLTC; 2) health utilisation among pregnant women with physical MLTC (physical conditions only) compared to those with physical-mental health MLTC (includes at least one mental health condition). Descriptive statistics will be used to describe baseline characteristics of the study cohort and healthcare utilisation outcomes. Healthcare outcomes will be stratified by ethnicity and social deprivation to explore health access inequality. Modified Poisson regression will be used to generate adjusted risk ratios for each of the healthcare utilisation outcomes. The pattern of missing data will be assessed and where appropriate addressed with multiple imputation with chain equation.
Findings will improve patient care through informing subsequent co-design of guidance for service provision.
Source - and 10 more projects — click to show
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A Post-Authorisation Safety Study (PASS) of ABRYSVO (Respiratory Syncytial Virus Stabilised Prefusion Subunit Vaccine) in Pregnant Women and their Offspring in a Real World Setting in Europe and UK — Debabrata Roy ...
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A Post-Authorisation Safety Study (PASS) of ABRYSVO (Respiratory Syncytial Virus Stabilised Prefusion Subunit Vaccine) in Pregnant Women and their Offspring in a Real World Setting in Europe and UK
Datasets:GP data, CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-23
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Samantha Lane - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Denise Morris - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Saad Shakir - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
The below are applicable to both the primary and secondary objective:
Pregnancy outcomes:
⢠Preterm delivery or birth among livebirths:
- Extremely preterm delivery or birth (Description: Lay Summary
In 2023, a new vaccine called Abrysvo, made by Pfizer, was approved in the United Kingdom (UK) and European Union (EU) to protect newborn babies from a lung infection caused by a virus called RSV (respiratory syncytial virus). In the UK, Abrysvo is given to people who are between 28 and 36 weeks pregnant. A global study showed that this vaccine is safe, but more research is needed to confirm its safety for those with weakened immune systems or high-risk pregnancies, as they were not included in earlier studies.
A new UK study will investigate Abrysvo's safety during pregnancy. It will look at outcomes like early birth, pregnancy loss after 24 weeks, and the time between vaccination and birth. It will also examine health issues in mothers, such as high blood pressure during pregnancy and a rare reaction where the immune system attacks the nerves called Guillain-Barré Syndrome. The study will also examine birth outcomes like low birthweight and small size for the baby's stage of pregnancy.
The study will compare these outcomes between people who receive the vaccine and those who do not, while considering characteristics such as age, medical conditions, and other vaccines received during pregnancy. The UK findings will be combined with results from similar studies in Spain, Denmark, France, the Netherlands, and Norway to provide a clearer understanding of the safety of Abrysvo for pregnant people in Europe.
Technical SummaryThe Pfizer Abrysvo vaccine was approved for use in the European Union (EU) and United Kingdom (UK) in August and November 2023, respectively, to provide protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants 0-6 months of age, following maternal immunisation during pregnancy. In the UK, the MHRA have approved the use of Abrysvo between 28-36 weeks gestation. Initial data from the MATISSE trial (NCT04424316, C3671008) provided evidence for the safety of Abrysvo. However, to gain a more complete understanding, particularly in immunocompromised pregnant women and high-risk pregnancies (excluded from the trial), safety monitoring of Abrysvo is required in the UK and other European countries.
The Vaccine monitoring Collaboration for Europe (VAC4EU), on behalf of Pfizer, are conducting this post-authorisation safety study across electronic health records databases from six countries, to fulfil regulatory requirements in the EU, UK, and the United States. This CPRD study forms the UK arm of the study. Aggregate results from CPRD analyses (with small cell counts masked as â
Source -
RECODE: Renal & Cardiovascular Disease Epidemiology: a multidatabase descriptive study in the US, UK and Japan in patients with CKD stages 3 and 4 — Daloha Rodriguez Molina ...
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RECODE: Renal & Cardiovascular Disease Epidemiology: a multidatabase descriptive study in the US, UK and Japan in patients with CKD stages 3 and 4
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-11
Organisations:
Daloha Rodriguez Molina - Chief Investigator - Bayer AG
Daloha Rodriguez Molina - Corresponding Applicant - Bayer AG
David Vizcaya - Collaborator - Bayer AG
Glen James - Collaborator - Bayer AG
Juho Immonen - Collaborator - Bayer AGOutcomes:
Depending on data availability, some of the following outcomes may not be ascertained. Specifically for CPRD Aurum and CPRD Gold, a specification is available next to the outcome if it's not available to us in CPRD data without hospital linkage (which we are not requesting):
HCRU will be defined as a record of any of the following within the patientsâ medical record:
o Hospitalization: an observation of hospital admission or visit occurrence of inpatient visit
o Re-hospitalization within 30 days post discharge (not available for this study in CPRD Aurum and CPRD Gold but available in databases from the US and Japan)
o Outpatient visit: a visit occurrence of outpatient visit
o Intensive care unit (ICU) stays: an observation of admission to intensive care unit or a visit occurrence of intensive care
o Emergency department (ED) visit (not available for this study in CPRD Aurum and CPRD Gold but available in databases from the US and Japan)Several clinical outcome definitions will be defined as follows:
1. A composite of:
o A decrease in eGFR â¥50% from baseline with a gap of at least 28 days between measures
o Onset of kidney failure, defined as the first occurrence of any of the following:
ï§ â¥ 2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days. eGFR determinations should be based on only outpatient measurements (inpatient measurements are more likely to be associated with transient changes in eGFR associated with acute events)
ï§ Record of dependence on dialysis (at least 3 sessions over at least 90 days)
ï§ Diagnosis records of kidney failure or CKD stage 5
ï§ Record of kidney transplant
o Renal death
o CV death2. A composite of:
o A decrease in eGFR â¥50% from baseline with a gap of at least 28 days between measures
o Onset of kidney failure, defined as the first occurrence of any of the following:
ï§ â¥ 2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days. eGFR determinations should be based on only outpatient measurements (inpatient measurements are more likely to be associated with transient changes in eGFR associated with acute events)
ï§ Record of dependence on dialysis (at least 3 sessions over at least 90 days)
ï§ Diagnosis records of kidney failure or CKD stage 5
ï§ Record of kidney transplant
o Renal death (see below, section 9.6.2.1)
o CV death (see below, section 9.6.2.2)
o MI: patients with evidence of myocardial infarction before or on the index date will be excluded from the analyses of this composite outcome
o Stroke: patients with evidence of stroke before or on the index date will be excluded from the analyses of this composite outcome3. A composite of:
o A decrease in eGFR â¥50% from baseline with a gap of at least 28 days between measures
o Onset of kidney failure, defined as the first occurrence of any of the following:
ï§ â¥ 2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days. eGFR determinations should be based on only outpatient measurements (inpatient measurements are more likely to be associated with transient changes in eGFR associated with acute events)
ï§ Record of dependence on dialysis (at least 3 sessions over at least 90 days)
ï§ Diagnosis records of kidney failure or CKD stage 5
ï§ Record of kidney transplant
o Renal death (see below, section 9.6.2.1)
o CV death (see below, section 9.6.2.2)
o MI: patients with evidence of myocardial infarction before or on the index date will be excluded from the analyses of this composite outcome
o Stroke: patients with evidence of stroke before or on the index date will be excluded from the analyses of this composite outcome
o hHF4. A composite of:
o CV death
o MI: patients with evidence of myocardial infarction before or on the index date will be excluded from the analyses of this composite outcome
o Stroke: patients with evidence of stroke before or on the index date will be excluded from the analyses of this composite outcome
o hHF5. A composite of:
o CV death
o MI: patients with evidence of myocardial infarction before or on the index date will be excluded from the analyses of this composite outcome
o Stroke: patients with evidence of stroke before or on the index date will be excluded from the analyses of this composite outcome6. A composite of:
o CVD
o hHF7. All-cause mortality
8. Onset of kidney failure, defined as the first occurrence of any of the following:
o ⥠2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days. eGFR determinations should be based on only outpatient measurements (inpatient measurements are more likely to be associated with transient changes in eGFR associated with acute events)
o Record of dependence on dialysis (at least 3 sessions over at least 90 days)
o Diagnosis records of kidney failure or CKD stage 5
o Record of kidney transplant9. A composite of:
o Non-proliferative diabetic retinopathy (NPDR)
o Diabetic retinopathyHere are initial feasibility counts for each of these outcomes in the data we have currently available without hospital linkage for CPRD Aurum and CPRD Gold:
Outcome | Count in CPRD Aurum | Count in CPRD Gold
Hospitalization | 2,825,373 | 1,480,391
Re-hospitalization | 0 | 0 (not to be ascertained in CPRD Gold or Aurum, but will be ascertained in other databases)
Outpatient visits | 37,642,825 | 16,738,526
ICU stays | 13,813 | 5,785
ED visits | 0 | 0 (not to be ascertained in CPRD Gold or Aurum, but will be ascertained in other databases)
Composite: kidney failure, renal death, CV death | 80,790 | 35,278
Composite: kidney failure, renal death, CV death, MI, stroke | 589,272 | 288,967
Composite: kidney failure, renal death, CV death, MI, stroke, hHF | 616,981 | 616,981
Composite: CVD, hHF | 1,629,197 | 819,273
Composite: CV death, MI, stroke | 527,747 | 262,144
Composite: CV death, MI, stroke, hHF | 556,327 | 273,842
Kidney failure | 42,572 | 20,437
All-cause mortality | 2,575,542 | 1,318,234
NPDR or diabetic retinopathy | 507,978 | 205,527Description: Lay Summary
Chronic kidney disease happens when a person's kidneys are unable to work properly. A person with this disease often has other diseases like heart problems and may die young. There is no cure for chronic kidney disease. . People with chronic kidney disease should receive medical help and medicines to make sure that their kidneys do not get more damage but also to avoid that they have these heart problems or that they die young. The medical help and medicines that already exist are still not enough to help all patients with chronic kidney disease. This is why Bayer is trying to create new medicines to help more patients with this disease. Before finishing creating these new medicines, we would like to understand how many are the patients with chronic kidney disease, which other diseases they have, what type of medicines they take, how often they go to the doctor or the hospital, and what kind of other health problems they have, as long as they are adults with chronic kidney disease and heart problems.
Technical SummaryChronic kidney disease (CKD) is defined as abnormalities of kidney structure or function, present for more than 3 months, with substantial morbidity and premature mortality. Patients with CKD have an increased risk of kidney failure, cardiovascular disease (CVD), and premature death. Thus, the treatment goal in CKD is not only to delay the onset of needing renal replacement therapy, but also to reduce the risk of major adverse CV events (CV death, myocardial infarction, stroke) and hospitalization for heart failure (hHF). Despite evolving standard of care for patients with CKD, there remains substantial residual risk of renal and CV events and a high unmet need. Therefore, Bayer is currently exploring potential new treatment compounds to delay the progression of CKD and to reduce the risk of major adverse CV events in adult patients with CKD. In order to better understand the patient population that could potentially benefit from such new compounds in the future, we have designed the RECODE study, which aims at understanding the real-world patient profile, drug utilization, healthcare resource utilization (HCRU) and clinical outcomes of adult patients with CKD and at least 1 major or 2 minor CV risk factors. Nested cohorts will consist of patients with at least 1, at least 2, at least 3, at least 4 and at least 5 major or minor risk factors. Risk factors include myocardial infarction, stroke, obesity, diabetes, smoking, and other related and common entities. This study will be conducted with all available data from 2012 until the latest data available. Data sources include Optum Clinformatics, Optum EHR, Merative MarketScan, CPRD Aurum, CPRD Gold, RWD Co. and MDV. The description of patient characteristics will be done with absolute and relative counts, while incidence rates of HCRU and clinical outcomes will be calculated.
Source -
Cohort study investigating the natural history of recurrent tonsillitis among adults in English general practice — Samuel Finnikin ...
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Cohort study investigating the natural history of recurrent tonsillitis among adults in English general practice
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-17
Organisations:
Samuel Finnikin - Chief Investigator - University of Birmingham
Samuel Finnikin - Corresponding Applicant - University of Birmingham
James O'Hara - Collaborator - Newcastle University
Tom Marshall - Collaborator - University of BirminghamOutcomes:
Episodes of tonsillitis, tonsillectomy and antibiotic prescribing
Description: Lay Summary
Approximately 16,000 tonsil removal surgeries are performed yearly in adults in England, the majority of which are to treat recurrent infection of the tonsils. In the United Kingdom, tonsil removal surgery is recommended to patients based on the number of sore throat episodes which limits daily activity functioning. People may be offered tonsillectomy if they experience seven or more episodes of sore throat in a year, five or more episodes in the preceding two years or three or more episodes in the preceding three years. However, the evidence behind this recommendation based on information gained in children with tonsillitis and it is not clear that this is the best way of deciding who would be offered treatment.
The benefit of having a tonsillectomy is that it reduces the chances of having further sore throat episodes. However, one of the problems is that we do not have a good understanding of the pattern of sore throats and tonsillitis in the adult population. This research aims to improve our understanding of who is experiencing sore throats and tonsillitis, and which people are more likely to go on and have recurrent problems. This would help ensure that the right patients are being offered tonsillectomy at the right time. Additionally, an improved understanding in this area would allow us to give better information to patients about the potential benefits of having surgery (tonsillectomy) which would be useful to them when making this important decision.
Technical SummaryApproximately 16,000 tonsillectomies are performed annually in adults to treat recurrent tonsillitis in the National Health Service (NHS) England. (1) In United Kingdom, recommendation for tonsillectomy is based on sore throat episodes due to acute tonsillitis which prevents normal functioning, (1) but the criteria for offering tonsillectomy is predominantly extrapolated from the paediatric tonsillectomy data along with consensus recommendations.(2, 3) Using this threshold for adult tonsillectomy, the procedure shows a reduction in sore throat days compared with conservative management with corresponding cost-effectiveness. (4) However, what is not known is whether the this is the most effective way of identifying patients who would benefit most from tonsillectomy.
To improve our understanding of the epidemiology of sore throat and tonsillitis, a cohort will be created comprising patients aged >16 years who experience an episode of sore throat/tonsillitis with a matched control group who do not. All episodes of sore throat/tonsilitis in the preceding 3 years and subsequent years of follow up will be identified noted along with sociodemographic variables and smoking status. Concurrent antibiotic prescriptions and referrals to Ear Nose and Throat specialists (ENT) and subsequent tonsillectomies will be established.
The pattern of sore throat and tonsillitis will be described, and linear Poisson regression will be performed for the incidence of sore throat as well as logistic regression for the outcome of tonsillectomy. Sensitivity analysis looking at only episodes where antibiotics were prescribed and where only tonsillitis codes were used will be undertaken.
It is envisaged that by better understanding the epidemiology and management of sore throats and tonsillitis in primary care we can consider better ways to select who may benefit from tonsillectomies and inform discussions about the potential benefits of this procedure to improve commissioning and shared decision-making.
Source -
Integration of a harmonised database for maternal and child health for UK-wide federated epidemiological analyses — Krishnarajah Nirantharakumar ...
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Integration of a harmonised database for maternal and child health for UK-wide federated epidemiological analyses
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-12-09
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Arturo Gonzalez-Izquierdo - Corresponding Applicant - University of Birmingham
Jingya Wang - Collaborator - University of Birmingham
Katherine Phillips - Collaborator - University of Birmingham
Megha Singh - Collaborator - University of Birmingham
Neil Cockburn - Collaborator - University of BirminghamOutcomes:
Antenatal: Vomiting; hyperemesis gravidarum; ectopic pregnancy; miscarriage; termination; hypertensive disorders; obstetric cholestasis; gestational diabetes; placenta issues; chorioamnionitis; foetal growth restriction; intrauterine death.
Peripartum: Maternal/neonatal mortality; stillbirth; birth modes; labour induction; gestational age; preterm birth; severe morbidity; ITU admission; hysterectomy; infections; perineal trauma; epidural; hospital stay; blood transfusion; analgesia; anaesthesia.
Postpartum and Long-term Outcomes for Women: Haemorrhage; incontinence; new/existing long-term conditions.
Children Outcomes: Resuscitation; intubation; birth injury; sepsis; respiratory issues; abstinence syndrome; brain injury; congenital anomalies; neurodevelopmental disorders; death; hypoglycaemia; jaundice; hearing/visual impairment; growth issues; breastfeeding.
Mental Health Outcomes: Antenatal/postnatal anxiety; depression; psychosis; self-harm/suicide attempt.Description: Lay Summary
The Mother & Infant Research Electronic Data Analysis (MIREDA) partnership aims to improve the health of mothers and their children in the UK, particularly among disadvantaged groups, by developing new resources and tools for research that uses routinely collected data. It will do so by bringing together people and datasets from existing UK research programmes studying health data from pregnancy to early childhood. The Multimorbidity and Pregnancy: Determinants, Clusters, Consequences and Trajectories (MuMPreDiCT) consortium additionally focuses on pregnant women with multiple long-term health conditions. Both initiatives use existing health records aiming to predict and prevent disease, and to understand and reduce health inequalities, for both mothers and their children. Through the shared perspective of these two partnerships and building on the work already done by the MuMPreDiCT consortium, this project will create a database representing English mothers and their children, that will allow for direct comparison with other maternity populations in the UK. The main objectives of this project are (a) to combine anonymised primary and secondary care data for the creation of a comprehensive database showing social, demographic and medical characteristics of pregnancies, mothers, and children; (b) to promote studies on maternal and infant health using these data, focusing on conditions like obesity, high blood-sugar, or infectious diseases; and (c) to facilitate research through a joined-up approach that combines comparable results from other maternity populations across the UK. This database will be made accessible to researchers in collaboration with the University of Birmingham and under strict data security measures.
Technical SummaryThe Mother & Infant Research Electronic Data Analysis (MIREDA) partnership aims to integrate and harmonise health data from birth cohorts and electronic health records to study maternal and infant health in the UK. This initiative will use similar directives, the baseline population and phenotyping definitions from the The Multimorbidity and Pregnancy: Determinants, Clusters, Consequences and Trajectories (MuMPreDiCT) consortium, which focuses on multiple long-term health conditions (MLTCs) in pregnant women at different stages: antenatal, peripartum, postnatal, and long-term. The research of both initiatives shares a focus on short- and long-term impacts of conditions like hypertension, obesity, diabetes, and infectious diseases on pregnancy and childhood outcomes, as well as womenâs experiences of MLTC in pregnancy, polypharmacy and current health service provision. An important area of research will be on socio-demographic differences in maternal health risks and regional analysis of public health programs. Given these commonalities, the main objectives of this project are (a) to use linked primary and secondary care data to create a harmonised health dataset representing pregnancies, mothers, and children in England, adhering to modified OMOP data standards; (b) to facilitate access to the curated dataset via the HDR UK Gateway and CPRD custodianship; and (c) to enable federated research on maternal and infant health, combining evidence across the UK.
This project will align the current definitions and algorithms from MuMPreDiCT and MIREDA, to generate a comprehensive database, harmonised using OMOP data standards, of curated pregnancy and birth records from the Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES) and supplementing them with mortality and socioeconomic indicators from the Office for National Statistics. This resource, which will include analysis tools, data-standardisation, data-management approaches, and automation methods, will greatly facilitate access to and use of linked routine data by UK researchers, enabling them to build national and international collaborations.
Source -
Extension ID-435-1: Fine-tuning and Validating a Type 1 Diabetes Risk Prediction Algorithm — Stanhope Mews Surgery...
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Extension ID-435-1: Fine-tuning and Validating a Type 1 Diabetes Risk Prediction Algorithm
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-24
Opt Outs: no information provided./p>
Organisations: Stanhope Mews Surgery
Description: Diabetes. Commercial
Source -
ID-438: Societal and environmental drivers of CVD heterogeneity and multimorbidity — Imperial College London...
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ID-438: Societal and environmental drivers of CVD heterogeneity and multimorbidity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: CVD.
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ID-441: Care Home in-Reach Liaison Service (CHILS) Evaluation — West London NHS Trust...
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ID-441: Care Home in-Reach Liaison Service (CHILS) Evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-24
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Care homes.
Source -
Extension ID-156-5: Autism JSNA — Wesminster City Council...
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Extension ID-156-5: Autism JSNA
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-24
Opt Outs: no information provided./p>
Organisations: Wesminster City Council
Description: Autism.
Source -
ID-439: Making the economic case for remote glucose monitoring during chemotherapy — Chelsea and Westminster NHS Foundation Trust...
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ID-439: Making the economic case for remote glucose monitoring during chemotherapy
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-24
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster NHS Foundation Trust
Description: Chemotherapy.
Source -
ID-440: Care Connection Team Evaluation — Central and North West London NHS Foundation Trust...
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ID-440: Care Connection Team Evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-24
Opt Outs: no information provided./p>
Organisations: Central and North West London NHS Foundation Trust
Description: Team evaluation.
Source
2024 - 11
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— unknown...
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Where: unstated
When: 2024-11-5
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding four Research Fellowships to analyse the Longitudinal Education Outcomes (LEO) dataset. These projects will generate novel insights around peopleâs pathways through education and work, with the potential to inform policy decision-making and improve public outcomes. The projects are a result of ADR UK Fellowship opportunities which invited applications to carry out research using eligible ADR England flagship datasets.
LEO is a world-leading data product created by the Department for Education. It contains de-identified information on the characteristics, education, employment, benefits, and earnings of members of the British public. This is a unique source of information, offering unprecedented opportunities for researchers to examine longer-term labour market outcomes and educational pathways of (currently) around 38 million individuals.
The fellows are addressing a range of policy-relevant issues, from understanding earnings in the creative industries to exploring the impact of vocational education and STEM (science, technology, engineering, and mathematics) subject readiness. They are accessing the dataset via the Office for National Statistics (ONS) Secure Research Service.
Learn more about the Research Fellows and their projects below.
Dr Orian Brook Analysing earnings from creative education and creative work: Understanding the influence of university, industry, and social inequalitiesOrian is Chancellorâs Fellow in Social Policy at the University of Edinburgh. Her project explores the earnings of graduates with creative degrees, and how they vary with industry of employment
Source -
Towards Precision Treatment for Type 2 Diabetes using Real-World Data: When And How Should Antihyperglycemic Therapy be Intensified among Individuals with Type 2 Diabetes and Multiple Chronic Conditions? — Daniala Weir ...
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Towards Precision Treatment for Type 2 Diabetes using Real-World Data: When And How Should Antihyperglycemic Therapy be Intensified among Individuals with Type 2 Diabetes and Multiple Chronic Conditions?
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-20
Organisations:
Daniala Weir - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
David Liang - Collaborator - Utrecht University
Vasilis Antoniadis - Collaborator - Utrecht UniversityOutcomes:
Myocardial infarction (MI), stroke, all-cause mortality
Description: Lay Summary
Diabetes, a condition where your body has trouble managing the sugar (glucose) in your blood) is a long-term disease affecting millions of people globally. In the UK, about 90% of diabetics have type 2 diabetes (T2DM). This type of diabetes worsens over time, leading to poor blood sugar control, and can cause severe issues like heart attacks and kidney failure if not managed well.
Many T2DM patients need two or more medications to keep their blood sugar in check. Doctors choose these medications based on the patient's other health problems, personal traits, and preferences, using their knowledge and existing research. However, there's little research on the best timing for adding extra medications if blood sugar remains uncontrolled. Understanding if starting a drug earlier affects the risk of future complications is challenging, as such clinical trials would need many participants and often exclude patients with other conditions like depression or Alzheimer's disease.
To address these gaps, we can analyze past data to make informed decisions. This study aims to help doctors choose the best treatment for each patient based on their unique characteristics like age, Body Mass Index, other health conditions, and lab results.
Technical SummaryRecent guidelines for type 2 diabetes (T2D) treatment emphasize the need to tailor pharmacotherapy based on patient comorbidities, rather than just HbA1c levels. Still, many physicians prefer metformin as the first-line treatment. Clinical decisions about intensifying diabetes therapy rely on research evidence, clinical expertise, and patient preferences, yet guidelines often exclude patients with severe or multiple comorbidities. We aim to develop a precision management approach by assessing individual risks associated with specific antihyperglycemic medications, potentially leading to a clinical decision support tool that improves personalized treatment and health outcomes. In this retrospective cohort study between 2012-2021, new users of metformin who either receive a first intensification step or stay on metformin until the occurrence of the outcomes of interest will constitute our study population. Since cardiovascular outcomes are one of the most important treatment outcomes to consider when prescribing antihyperglycemic therapies, we will focus on this outcome to initially test these hypotheses in the current study. We will obtain estimates for the probability of myocardial infarcton/stroke/all-cause mortality under each treatment strategy for each individual conditional on their characteristics using g-formula's. First, we will model the distribution of an outcome and covariates over time using maximum likelihood methods. Second, Monte Carlo simulation is used to approximate the weighted average under each treatment strategy. By generating indicators for a given outcome for individuals, a dataset is created which includes individuals trajectories had everyone followed treatment strategy. An interventional prediction model will be developed using the counterfactual trajectories calculated in the previous step. We will fit a model to the training sets (95% random sample of the counterfactual trajectories) simulated under each treatment strategy to predict the risk of outcome events had everyone received treatment under that strategy. We will use a nonparametric bootstrap to calculate prediction intervals for each individual risk estimate.
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Drug utilisation, patient characterisation and survival for populations of regulatory interest — Daniel Prieto...
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Drug utilisation, patient characterisation and survival for populations of regulatory interest
Datasets:GP data, CPRD GOLD Ethnicity Record; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-01
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Wanning Wang - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Marta Pineda Moncusi - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of OxfordOutcomes:
Summary characteristics (sex, age, risk factors, comorbidities, comedication) and mortality rates in the population of interest. Incidence and/or prevalence of drugs of regulatory interest in individuals with specific risk factors. Characteristics and duration of treatment in new users of drugs of regulatory interest.
Condition of regulatory interest:
⢠Recurrent falls
⢠Dementia
⢠InsomniaDescription: Lay Summary
The 'Data Analysis and Real-World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from real-world healthcare data sources from across Europe. One area of research relates to better understanding age, sex, and related conditions for patients with a specific condition and the types of medication they are prescribed. For regulators such as the EMA, it is important to have access to this kind information as it helps to understand the uptake of specific drugs over time and the distribution of potential health outcomes.
The objective of this study is to characterise patient populations, who are at risk of a specific condition or unwanted events, e.g. falls in older people, in terms of age, sex, risk factors, co-occurring conditions and death. Secondly, to estimate the new users (âincidenceâ) and existing users (âprevalenceâ) of medicines which may impact the risk for developing the condition/experience unwanted events and characterisation of patients taking the specific medicine. All these will be calculated in specific populations of interest based on age and sex groups, and over calendar years to look at possible changes over time.
The EMA will request several studies of the same design to assess characteristics of populations of interest and how often the population takes a certain drug. This will guide regulators in establishing preventative measures to reduce the health condition. The first example will focus on older patients with recurrent falls and drug that are considered potentially inappropriate for older people.
Technical SummaryPrimary care records provide a unique source of data for estimating the incidence and prevalence of medication use in the community, as most medicines are prescribed by general practitioners. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand patient characteristics and the uptake of specific drugs of interest for assessing disease burden in the population, EMA will commission several population-level studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: All people in CPRD GOLD with >=1 year of prior history comprise the source population. Among those, people with the pre-specified condition and those who are users of specific drug classes will be selected for characterisation.
Variables: Drug exposure based on prescription data as available within CPRD GOLD. Drugs will be selected by the respective RxNorm codes. Conditions will be identified based on SNOMED codes in the mapped data (CPRD). Date of death will be retrieved from CPRD.
Drug classes of interest as expressed by EMA:
⢠Drug classes pertaining to section K of the STOPP criteria
⢠AntipsychoticsConditions of regulatory interest:
⢠Recurrent falls
⢠Dementia
⢠InsomniaAdditional medicines and conditions of regulatory interest will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
Analyses:
(1) Characterisation of population of interest
(2) Overall survival of population of interest
(3) Prevalence of use of drugs of regulatory interest
(4) Incidence of use of drugs of regulatory interest
(5) Characterisation of new users of drugs of regulatory interest in the population of interest
(6) Median duration of use of drugs of interest in the population of interest
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Clinical and Economic Burden of Adults at risk for atherosclerotic cardiovascular disease in England — Arielle Marks...
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Clinical and Economic Burden of Adults at risk for atherosclerotic cardiovascular disease in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-18
Organisations:
Arielle Marks-Anglin - Chief Investigator - Merck & Co. Inc - Pennsylvania, USA
Jay Were - Corresponding Applicant - Parexel International Limited (UK)
Boshu Ru - Collaborator - Merck Sharp & Dohme LLC
Kausik Ray - Collaborator - Imperial College London
Lori Bash - Collaborator - Merck & Co., Inc.
Min Zhuo - Collaborator - Merck & Co., Inc.
Tanvee Thakur - Collaborator - Merck and Company, IncorporatedOutcomes:
Number and timing of ASCVD events (non-fatal stroke (IS), non-fatal MI (MI), Peripheral Ischemic Events (including Acute Limb Ischemia (ALI), urgent revascularization (R) or major amputation due to vascular etiology), cardiovascular and non-cardiovascular death; risk of ASCVD event (intermediate, high, very high risk); inpatient admissions (inpatient length of stay by type of admission); mortality (number and cause); Demographic profiles for each cohort and sub-cohort (Age at event, gender, ethnicity, BMI, total time in cohort, mean and median follow-up time, Charlson Co-morbidity Score, selected comorbidities, Geographic region) by Risk group (low, intermediate and high risk); and treatment patterns (prescription of lipid-lowering-therapies).
Description: Lay Summary
Cardiovascular disease (CVD) is a leading cause of death, sickness and reduced quality of life in Europe, including the UK, and is associated with significant clinical and cost burden. With more patients surviving their first cardiovascular (CV) event, CVD is also a major cause of disability, reduced quality of life, and poor clinical outcomes.
Technical Summary
Increased level of lipids is recognized as a causal risk factor of disease in which plaque builds up on the insides of arteries and its associated complications. Research has shown that the risk of occurrence of major clinical events such as heart attack, death due to heart disease, stroke or procedures to restore blood flow in blocked arteries can be reduced with a reduction in lipid levels.
Despite this, the British Heart Foundation estimated that about half of adults in the UK are living with lipid levels higher than the national recommendations for total cholesterol.
National guidance for the UK advocates primary prevention among adults with risk factors for CVDs, including lifestyle and dietary changes followed by medication that can reduce lipid levels, such as statin initiation. Despite effective options, many adults at risk go untreated or undertreated causing more than 160,000 deaths each year in the UK, accounting for 27% of all deaths.
This study will provide a more comprehensive understanding of the occurrence of major clinical events associated with high lipid levels, among adults at risk of these events. This information will support the development of interventions for the prevention and management of CVDs.Cardiovascular disease (CVD) is a leading cause of mortality, morbidity, and reduced quality of life in Europe, including the UK, and is associated with significant clinical and economic burden. It is the cause of about 4 million deaths every year in Europe, accounting for 45% of all deaths, and including more than 160,000 deaths each year in the UK, accounting for 27% of all deaths. With more patients surviving their first cardiovascular (CV) event, CVD is also a major cause of disability, reduced quality of life, and poor clinical outcomes.
Increased low-density lipoprotein cholesterol (LDL-C) is recognized as a direct cause of atherosclerotic CVD (ASCVD) and its major clinical sequelae. Research has shown that major vascular events were reduced by 21% over 5 years per 1âmmol/L of LDL-C reduction.
The British Heart Foundation estimated that about half of adults in the UK are living with cholesterol levels higher than the national recommendations for total cholesterol of 10% chance of a heart attack or stroke) are first offered lifestyle advice including dietary changes to lower cholesterol and, if that is not effective, are then offered lipid-lowering treatments, starting with statins.
Despite effective treatment options, a large proportion of adults with and at risk for ASCVD with elevated LDL-C remain un or undertreated.
This retrospective observational cohort study will describe demographics and clinical characteristics of adults, and frequency of and time to occurrence of subsequent ASCVD events including non-fatal stroke, non-fatal MI, Acute Limb Ischemia or amputation, urgent revascularization, cardiovascular death with the aim of providing a more comprehensive understanding of the occurrence of ASCVD events, among adults with and at risk for ASCVD events in England.
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The trends and drivers of antibiotic treatment failure in primary care — Jan Verbakel ...
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The trends and drivers of antibiotic treatment failure in primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains; Practice Level Index of Multiple Deprivation Domains; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Jan Verbakel - Chief Investigator - KU Leuven University
Fade Alkhlaileh - Corresponding Applicant - KU Leuven University
Annelien Dankaerts - Collaborator - KU Leuven University
Geert Molenberghs - Collaborator - KU Leuven University
Geert Verbeke - Collaborator - KU Leuven UniversityOutcomes:
Primary:
Rate and trends of ATF across demographics, socioeconomic status, antibiotics, and indications; Trends of ATF across time;
Rate of different ATF subtypes;
Characteristics of patient populations with frequent ATFs;
Association between demographics, socioeconomic status, comorbidities, medications, smoking, BMI, and ATF;
Characteristics of GP practices with frequent ATFs;
Association between practice-level antibiotic and medication prescribing patterns and ATF;
Association between practice-level demographics, socioeconomic status, and ATF;Secondary:
Total number of patients receiving antibiotic prescriptions;
Total number of prescriptions per antibiotic per indication;
Ratio of broad to narrow-spectrum antibiotic prescriptions;
Time from treatment to ATF occurrence;Description: Lay Summary
Antibiotics are medicines used to fight bacterial infections. However, sometimes these treatments don't work as well as they should. This problem is called Antibiotic Treatment Failure, and it's becoming more common in local healthcare settings like doctor's offices and clinics.
Our research aims to understand why antibiotic treatments fail for some people but work for others. We want to find out what factors might increase the risk of these treatments not working.To do this, we'll use the Clinical Practice Research Datalink's (CPRD) extensive medical databases to analyse trends and risk factors. By looking at this data, we hope to spot patterns and uncover potential factors that might make antibiotic treatments less effective.
Understanding why treatments fail is important because when antibiotics don't work it can lead to more serious infections and increased healthcare costs, which makes it harder for people to get better.
By finding out what causes these treatments to fail, we hope to develop better ways to prevent treatment failure, and improve how we use antibiotics.
This research could help doctors choose the most effective treatments for their patients, potentially leading to better health outcomes for everyone.
In the long run, this study could be an important step in making sure antibiotics work when we need them, which is crucial for public health.
Technical SummaryThe research project is designed to delve into the issue of Antibiotic Treatment Failure (ATF) in ambulatory healthcare settings using the extensive CPRD database.
Objective 1: The first objective aims to calculate ATF rates across various demographic and clinical variables. Specifically, Poisson regression models will be used to determine ATF rates based on age, sex, year, type of infection, antibiotic class, and socioeconomic status (using the CPRDâs Patient Level Index of Multiple Deprivation Domains linked data). Patients will be grouped based on their annual ATF frequency, with particular focus on individuals with above-average ATF occurrence. The HES and ONS Death Registry data will be used to determine escalation of treatment as a proxy for treatment failure, and as a measure of the consequences of ATF.
Objective 2: The second objective focuses on exploring the relationship between various risk factors and the occurrence of ATF. Multiple logistic regression models as well as mixed effects models will be employed to analyse how patient and practice level risk factors could influence the incidence of ATF.
Both objectives are geared towards enhancing our understanding of the mechanisms underlying ATF, thereby contributing to the development of more effective prevention strategies and treatments. The study will be supervised by a multidisciplinary team of experts in medical research, biostatistics, and clinical medicine.
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Prevalence of Eating Disorders in Children & Adults in England — Shehla Shamsuddin ...
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Prevalence of Eating Disorders in Children & Adults in England
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Shehla Shamsuddin - Chief Investigator - Office for Health Improvement and Disparities
Lanre Segilola - Corresponding Applicant - Office for Health Improvement and Disparities
Cam Lugton - Collaborator - Office for Health Improvement and DisparitiesOutcomes:
Primary outcomes: Point prevalence of ED (overall and sub-types) for England; point prevalence of ED by age, gender, ethnicity and deprivation for England.
Secondary outcome: Estimated local modelled prevalence of ED for ICBs and Upper Tier Local Authority (UTLAs).
Description: Lay Summary
Eating disorders (ED) are serious and can be life-threatening conditions, with some of the highest death rates among mental health disorder. Estimates suggest that around 1.25 million people in the UK are affected by these conditions. However, we don't fully understand the variation in prevalence of these conditions, how many children and adults in England have specific types of ED, is there any variation by geography or socio-demographic factors. Evidence suggests that the COVID-19 pandemic has made things worse, putting extra pressure on mental health services. It's crucial to know how many people need help with ED nationally and locally.
This study focuses on children and adults in England, estimating the numbers of different types of eating disorders there are at a recent point in time. Understanding this will help us quantify the numbers of people with an eating disorder in England and in different areas. By looking at different ages, genders, ethnicities, regions, and levels of deprivation, we can learn more about who is affected and where.
The results will help us plan better services for people with eating disorders. They will also support the NHS in making decisions about how to provide care for people with eating disorders across England, as part of its long-term plans for mental health services.
Technical SummaryED are serious, life-threatening conditions with some of the highest mortality rates of any mental health disorder. Estimates from 2019 suggest that around 1.25 million people in the UK are affected by an ED. Evidence suggests that the Covid-19 pandemic has worsened this situation, affecting individuals of all ages and putting increased pressure on mental health services, especially for children and young people (CYP).
There is a need to produce more informed estimates surrounding ED to help understand the mental health needs of children and adults at national and local levels, and to ensure that people have access to the right mental health support, in the right place, and at the right time.
The purpose of this study is to develop prevalence estimates of the number of people (10 - 65 years) with ED in England, and within each local area i.e., Integrated Care Boards (ICBs) and Local Authority. This is a cross-sectional observational study using the CPRD Aurum database. It will be undertaken in close consultation with an expert review group (ERG). A non-randomised ED cohort of children and adults (10 - 65 years) in England will be extracted from primary care data records based on diagnosis, and relevant combination of symptoms; using READ, SNOMED, and Medical codes.
After investigating the feasibility of producing ED prevalence estimates, national point prevalence estimates will be produced by condition type, age, gender, deprivation, ethnicity, and region using relevant statistical analysis. We will run a multivariate logistic regression model to identify which variables significantly affect ED prevalence. Finally, we will use a synthetic estimate approach to derive local prevalence estimates, applying national prevalence data to local populations to calculate estimated counts and proportions. This study will provide estimates of ED to support needs-based planning and commissioning of services for people with ED.
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Real-world utilization of and associated outcomes from direct oral anticoagulants for atrial fibrillation and stroke prevention in the United Kingdom — Yasuyuki Matsushita ...
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Real-world utilization of and associated outcomes from direct oral anticoagulants for atrial fibrillation and stroke prevention in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-08
Organisations:
Yasuyuki Matsushita - Chief Investigator - Daiichi Sankyo Co. Ltd. (Japan)
Rosa Wang - Corresponding Applicant - Daiichi Sankyo Co. Ltd. (Japan)
- Collaborator -
Allen Zhao - Collaborator - Not from an Organisation
Dong Dai - Collaborator - Daiichi Sankyo, Inc. (USA)
Michael DiFelice - Collaborator - Cobbs Creek Healthcare
Yichen Zhang - Collaborator - Cobbs Creek HealthcareOutcomes:
Major bleeding (primary) | systemic embolism | ischemic stroke | mortality | adherence and persistence |
Description: Lay Summary
The protocol is updated based on the approved protocol reference ID 20_136. The study period has been updated to include 2023/2024 data, the most recent data available from CPRD.
Atrial fibrillation (AF), the commonest form of arrythmia, is characterized by irregular, rapid heartbeat and increases the risk of stroke (five times), heart failure, and death (two-fold). AF treatment include oral anticoagulants, which prevent blood clots, the main driver of the associated stroke risk. Traditionally warfarin, a vitamin K antagonist (VKA), was mainly used however it requires careful dosage adjustment and regular blood tests to be used safely. Direct oral anticoagulant (DOACs) are easier to use and have been shown in clinical trials to not only reduce stroke risk in AF patients but also have a lower tendency to cause major bleeding compared to warfarin.
Technical Summary
There are four distinct DOAC drugs available in the UK, the newest of which was introduced between 2008 and 2015. The study will make comparisons between the newest, edoxaban, and each of the other alternative DOAC treatments, as well as warfarin.
This study will determine whether the benefits of DOACs observed in clinical trials can be observed in routine UK clinical practice. Specifically, the study will examine each of the DOACs and Warfarin in newly treated patients and see how they compare with each other in terms of : 1) major bleeding rates, strokes, mortality; 2) treatment adherence and persistence.AF, the commonest form of arrhythmia (1.5% prevalence), is characterized by irregular, rapid heartbeat increasing the risk of stroke (five times), heart failure, and death (two-fold). In the UK, a quarter of acute vascular events (the majority strokes) are AF-related incurring considerable human and healthcare costs.
AF treatment includes oral anticoagulation, preventing blood clotting, the main driver of the associated stroke risk. Warfarin, a VKA and the first line, requires careful dosage adjustment and regular blood tests to be used safely. Direct oral anticoagulant (DOACs), which are non-vitamin K antagonist, are easier to use and, in clinical trials, reduce stroke risk in AF patients and cause less major bleeding than warfarin.
Head-to-head efficacy and safety comparisons between the DOACs and warfarin using observational data have been made, though none from the UK.
Four distinct DOAC drugs are available in the UK, the newest of which was introduced between 2008 and 2015. The study will make new-user comparisons between the newest, edoxaban, and each of the other alternative treatments, as well as VKA warfarin by selecting propensity score (PS)-matched cohorts among anti-coagulant naïve patients with AF.
This study will determine the comparative effectiveness of each DOAC versus warfarin in routine UK clinical practice. Specifically, the study will assess whether in newly-treated patients and compared to warfarin, the use of each DOAC is associated with: 1) the rate of major bleeding, strokes, mortality; 2) treatment adherence and persistence.
Time-to-event analyses will use Cox proportional hazards regression, with censoring defined by either treatment switching, non-outcome related death, practice de-registration or database horizon. Generalized linear models will be constructed using the PS-matched cohorts to compare adherence and persistence between treatments. All multivariable models will be adjusted for baseline characteristics, including demography, comorbidities, and clinical status.
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Rates of co-prescribing of opioids with anti-anxiety medicines (benzodiazepines and Z-drugs): a population-based cohort study — Carol Coupland ...
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Rates of co-prescribing of opioids with anti-anxiety medicines (benzodiazepines and Z-drugs): a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Index; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Carol Coupland - Chief Investigator - University of Nottingham
Ruth Jack - Corresponding Applicant - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Roger Knaggs - Collaborator - University of NottinghamOutcomes:
Co-prescribing (defined as overlapping prescriptions) of opioids for non-cancer pain with benzodiazepines or Z-drugs, length of co-prescribing, most commonly prescribed combinations of medicines.
Description: Lay Summary
Opioids are strong medicines taken to relieve pain, and benzodiazepines and "Z-drugs" (e.g. zopiclone, zolpidem) are medicines commonly prescribed for insomnia and anxiety. These can have side effects and lead to addiction problems. There are also concerns that taking both medicines at the same time can lead to severe problems including increased risks of overdose, emergency hospital visits, and death. Some countries have issued safety alerts advising that these medicines should not be taken at the same time. Despite this, there is evidence that the numbers of people prescribed both medicines to be taken together have increased in the last 20 years.
In the UK, it is recommended that these medicines should only be prescribed at the same time if there is no alternative, but there is little information on how often the medicines are prescribed together or whether this has changed over time. We want to find out how often people have prescriptions from general practictioners (GPs) for opioids that overlap with prescriptions for benzodiazepines or Z-drugs, and whether this has changed over time. We also want to see whether certain groups of people, such as those from deprived areas, are more likely to be prescribed both types of medicine together. This information will help GPs, policymakers, and other researchers understand how many people in the UK may be at risk of harm from using both types of medicines at the same time. It will also help researchers design future studies about the safety of using these medicines together.
Technical SummaryOur study aim is to describe the extent of co-prescribing (defined as overlapping prescriptions) of opioids for non-cancer pain with benzodiazepines or Z-drugs in primary care, describe the rates of co-prescribing over time and assess whether there is any variation in rates of co-prescribing by socio-demographic characteristics.
We will establish a cohort of adults aged 18 years and over between 2011 to 2023 in CPRD AURUM and ascertain individuals who were prescribed opioids with benzodiazepines and/or Z-drugs over the period between 2011 and 2023. We will exclude people with a prior record of cancer, terminal illness (defined as people on the palliative care pathway), heart failure and opioid misuse disorder. We will calculate incidence and prevalence rates of co-prescribing in the general cohort of adults overall and by individual year to assess trends. We will also examine whether the rates of co-prescribing vary by socio-demographic factors including age, sex, ethnicity, deprivation, rural/urban status and region. We will use Poisson regression to calculate risk ratios for these comparisons, accounting for clustering at general practice level.
In addition we will summarise the duration of periods of co-prescribing of opioids with benzodiazepines and/or Z-drugs and will determine the incidence and prevalence rates of long-term co-prescribing, defined as a co-prescribing duration of 90 days or more. We will also describe the most frequent combinations of specific drugs that are co-prescribed.
Results of the study will be of interest to prescribers, policymakers and other researchers, as they will provide a useful description of the extent of opioid and benzodiazepines and Z-drugs co-prescribing in England. Any variation or trends found could lead to future work examining why such differences exist.
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Sedative medications and their effect on respiratory outcomes in patients with asthma and COPD — Lisong Zhang ...
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Sedative medications and their effect on respiratory outcomes in patients with asthma and COPD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-15
Organisations:
Lisong Zhang - Chief Investigator - University of Leicester
Lisong Zhang - Corresponding Applicant - University of Leicester
Dominick Shaw - Collaborator - University of Leicester
Laura Gray - Collaborator - University of Leicester
Tricia McKeever - Collaborator - University of NottinghamOutcomes:
Outcomes to be measured include acute exacerbation of COPD (AECOPD), acute exacerbation of asthma (AAE), pneumonia, lower respiratory tract infection (LRTI), and the hospitalisation/death due to the aforementioned reasons.
Description: Lay Summary
One of the causes of death is episodes of worsening breathing which is called an exacerbation. Clinical observations show that the exacerbations may be associated with the prescriptions of the sedative medications which are often taken to ease the symptoms for the respiratory disease patients. However, there is little data or literature on how to manage this issue best. Using data collected from general practices all over the country, we will establish the effect of sedative drugs and the risk of exacerbation of respiratory diseases. The findings from this study could provide more evidence of the potential harm of sedative medications.
Technical SummaryBackground
People with COPD/ asthma who take sedative medications had been shown to have higher probability of experience exacerbation, lower respiratory tract infection (LRTI) and pneumonia. However, the strength of association between the risk and the exacerbation are not yet established. At the same time, oral corticosteroid (OCS) and inhaled corticosteroid (ICS) are commonly prescribed for controlling airway inflammation in asthma.
Objectives:
The overall aim of the study is to investigate the hypothesis that certain sedative drugs often taken for chronic pain impact on the incidence and severity of outcomes, including exacerbation, lower respiratory tract infection, pneumonia and hospitalisation, in those with asthma or COPD.Design
A real-world observational study using linked primary care, hospitalisation data of people with COPD/ asthma from 1st April 2004 to 31st December 2023. Nested case-control study and self-controlled case series study will be conducted to investigate the association between the sedative medications and outcomes.Methods
The risk of sedative medications on the exacerbation of COPD, or exacerbation of asthma, pneumonia, LRTI will be assessed using conditional logistic regression and conditional poisson regression. In this study, we will treat OCS and ICS as other treatments in the sensitivity analysis of the association between sedative medications and the outcomes.
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Post-Authorisation Safety Study of Comirnaty Original-Omicron Bivalent Vaccines in Europe — Debabrata Roy ...
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Post-Authorisation Safety Study of Comirnaty Original-Omicron Bivalent Vaccines in Europe
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-27
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Samantha Lane - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Denise Morris - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Saad Shakir - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
The adverse events of special interest (AESI) that will be the safety outcomes in this study are:
(a) Autoimmune diseases, including: Guillain-Barré Syndrome*, Acute disseminated encephalomyelitis, Narcolepsy*, Acute aseptic arthritis, Diabetes mellitus type I, (Idiopathic) Thrombocytopaenia*, Thrombosis Thrombocytopaenia syndrome*, Myositis;
(b) Cardiovascular diseases: Acute cardiovascular injury, Arrhythmia, Heart failure, Stress cardiomyopathy, Coronary artery disease, Myocarditis*, Pericarditis*, Myocarditis or Pericarditis*;
(c) Circulatory system: Coagulation disorders (thromboembolism, haemorrhage), Single organ cutaneous vasculitis, Cerebral venous sinus thrombosis;
(d) Hepato-gastrointestinal and renal system: Acute liver injury, Acute kidney injury, Acute pancreatitis, Rhabdomyolysis, Glomerulonephritis;
(e) Nerves and central nervous system: Generalised convulsion, Meningoencephalitis, Transverse myelitis*, Bellâs palsy;
(f) Respiratory system: Acute respiratory distress syndrome;
(g) Skin and mucous membrane, bone and joints system: Erythema multiforme, Chilblain-like lesions;
(h) Reproductive system: Secondary amenorrhoea, Hypermenorrhoea;
(i) Other system: Anosmia, ageusia, Anaphylaxis*, Multisystem inflammatory syndrome, Death (any cause), Subacute thyroiditis, Sudden death;
(j) Pregnancy outcome, maternal: Gestational diabetes, Preeclampsia, Maternal death;
(k) Pregnancy outcome, neonatal: Foetal growth restriction, Spontaneous abortion, Stillbirth, Preterm birth, Major congenital anomalies*, Microcephaly, Neonatal death, Termination of pregnancy for foetal anomaly, Small size for gestational age;
(l) Any: Severe COVID-19*.Clinical validation will be considered for AESI denoted by an asterisk (*). Appendix 1 shows the AESI with estimated risk intervals and preferred study design.
Description: Lay Summary
In November 2021, the World Health Organisation announced Omicron, a new type of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19. Omicron has since become the main type of SARS-CoV-2 spreading worldwide.
The original vaccines made to fight the spread of COVID-19 were considered less effective at protecting against Omicron. In response, two new vaccines were developed by Pfizer-BioNTech.
The new vaccines protect against both the original type as well as Omicron. Different versions of the new vaccine (for different types of Omicron) were approved as booster doses by the UK and European medicines regulators in September and November 2022.
Based on early findings from studies in the United States, these vaccines appear to be as safe as the original Pfizer-BioNTech COVID-19 vaccine (Comirnaty), however further information is required to understand their safety in the European population.
This UK study will look at peopleâs risk of developing side effects following booster vaccination with a Pfizer-BioNTech COVID-19 Original/Omicron vaccine compared with not receiving a COVID-19 vaccine booster dose, considering characteristics like age, sex, medical conditions, and prior COVID-19 vaccination. Similar studies happening in four other European countries (Spain, Italy, the Netherlands, and Norway) will be included in the overall study, to develop a complete picture of the safety of these vaccines in European people.
Technical SummaryComirnaty Original/Omicron BA.1 (bivalent BA.1; Riltozinameran) and Comirnaty Original/Omicron BA.4-5 (bivalent BA.4-5; Famtozinameran) were approved in the UK and European Union for use as booster COVID-19 vaccines in September 2022 and November 2022, respectively. Initial safety data from the United Statesâ systems Vaccine Adverse Event Reporting System (VAERS) and V-Safe, indicated that the safety profiles of these Pfizer-BioNTech bivalent vaccines were in line with that of the Pfizer-BioNTech monovalent COVID-19 vaccine. However, to gain a more complete understanding, safety monitoring of the bivalent Pfizer-BioNTech COVID-19 booster vaccines is needed in European Countries.
The Vaccine monitoring Collaboration for Europe (VAC4EU), on behalf of Pfizer and BioNTech Manufacturing GmbH are conducting this study across electronic health records databases in five countries; this CPRD study will contribute UK data.
The study aims to determine whether there is an increased risk of selected adverse events of special interest (AESIs) after vaccination with bivalent BA.1 or bivalent BA.4-5 compared with no vaccination against COVID-19 among individuals with comparable vaccination history.
Retrospective, matched cohort design and self-controlled risk interval methodology will be used to describe incidence rates and determine whether an increased risk of prespecified AESI exists following administration of at least one dose of bivalent BA.1 or bivalent BA.4-5 compared with a matched comparator group who had not received any COVID-19 vaccine during follow-up, within sub-cohorts of interest. A subgroup secondary analysis will provide information on the safety of bivalent BA.1 or bivalent BA.4-5 use in pregnancy, including maternal and neonatal outcomes.
The study is designated as a Post-Authorisation Safety Study and is a commitment to the European Medicines Agency (EMA). Results from CPRD analyses will be pooled with aggregate results from European Data Access Providers using a Digital Research Environment. CPRD approval has been obtained for the aggregation of results (Query Reference number 00077310).
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Epidemiology and Risk Characterisation of Vitiligo using a Large UK Population-Based Dataset — Scott Kelly ...
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Epidemiology and Risk Characterisation of Vitiligo using a Large UK Population-Based Dataset
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-01
Organisations:
Scott Kelly - Chief Investigator - Pfizer Ltd - UK
Emma Jones - Corresponding Applicant - Momentum Data Ltd
Andrew McGovern - Collaborator - Momentum Data Ltd
Anita Lynam - Collaborator - Momentum Data Ltd
David Barnes - Collaborator - Pfizer Inc - US Headquarters
Guohai Zhou - Collaborator - Pfizer Inc - US Headquarters
Kennedy Cook - Collaborator - Pfizer Inc - US Headquarters
Milena Gianfrancesco - Collaborator - Pfizer Inc - US Headquarters
Serhan Bahit - Collaborator - Momentum Data LtdOutcomes:
⢠Vitiligo.
⢠Selected AEs, comprising: opportunistic infections; herpes zoster; herpes simplex; all cause death; psychiatric conditions (anxiety, mood, and personality disorders, and suicidal ideation or behaviour); depression; diabetes (type 1 and type 2); autoimmune thyroiditis (including Hashimoto thyroiditis); rheumatoid arthritis; systemic lupus erythematosus; Sjorgenâs syndrome; myasthenia gravis; systemic sclerosis; autoimmune blistering diseases (epidermolysis bullosa, pemphigus vulgaris, and bullous pemphigoid); psoriasis; pernicious anaemia; alopecia areata; serious infections; primary malignancy (excluding non-melanoma skin cancer [NMSC] and cervical carcinoma in situ); NMSC (includes basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]); deep vein thrombosis (DVT); pulmonary embolism (PE); Venous thromboembolism (VTE); arterial thrombosis/ thromboembolism; major adverse cardiovascular event (MACE); cardiovascular death; acute myocardial infarction; unstable angina; coronary revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); ischemic stroke; haemorrhagic stroke; heart failure with hospitalization; peripheral neuropathy; hearing loss; sensorineural hearing loss; paraesthesia and dysesthesia.Description: Lay Summary
Vitiligo is an autoimmune condition, i.e. a condition in which the immune system attacks its own healthy cells. In the case of vitiligo, the targeted cells are those responsible for skin pigmentation, resulting in a patchy loss of skin colouring that can appear anywhere on the body. The size, number, and extent of the colouring loss of these patches varies between patients. Vitiligo can occur at any age, and having it may increase the risk of developing other conditions.
The number of people in the UK diagnosed with vitiligo and the long-term health impact of this disease have not been well studied. This study will estimate the number of adults and children affected by vitiligo in the UK and explore their associated health issues. The study will also assess if the risk of developing vitiligo is affected by age, sex, ethnic background and level of income, and will explore whether having vitiligo makes people more likely to develop other health conditions. The occurrence of common side-effects associated with the drugs used to treat vitiligo will also be assessed in patients and compared to the general population.
This study will have clear patient benefit by providing information that will both support health professionals understand which people have a greater risk of developing vitiligo and treating patients with vitiligo, particularly those who are at an increased risk of drug side-effects.
Technical SummaryVitiligo is a skin disorder affecting 0.5-2.0% of the global population. It is characterised by depigmented patches of skin distributed throughout patientsâ body or restricted to certain areas. People with vitiligo are at an increased risk of other autoimmune and non-immune-mediated chronic conditions. Current epidemiological evidence is limited, as is understanding of associations between vitiligo and other conditions.
We will conduct a large-scale investigation of the epidemiology of vitiligo, including assessment of incidence rates of selected adverse events (AEs). People with vitiligo will be identified using clinical diagnosis codes recorded in primary care. All adults and children registered from March 2012, with valid data linkage to hospital episode statistics, death registration from the office of national statistics and index of multiple deprivation, will be eligible. A smaller cohort will be selected from the initial group to include vitiligo patients similar to those enrolled in the ritlecitinib vitiligo clinical trial program. Additionally, people with vitiligo will be matched 1:5 to unaffected controls. Vitiligo incidence rates (IRs; number of cases / total population person-years) prevalence, and lifetime risk (cumulative lifetime incidence from modified survival analysis), will be calculated overall and in sociodemographic-defined subgroups, alongside with a description of comorbidities and medication histories. AEs background IRs will be estimated in patients and unaffected controls. Risk of AEs will be assessed using incidence rate ratios (IRRs) using Poisson regression, to compare the rate of AEs of interest in people with and without vitiligo.
The results of this study will offer valuable insights into the risk characterisation of vitiligo, including associated comorbidities and treatment-related AEs. This knowledge will contribute to informing patients' risk assessment, enabling more personalised treatment decisions and improving patientsâ monitoring. Furthermore, the outcomes of this project will support the ongoing ritlecitinib vitiligo clinical trial program and facilitate the product registration process.
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Pediatric Hypertension Feasibility Assessment — Jay Were ...
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Pediatric Hypertension Feasibility Assessment
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-13
Organisations:
Jay Were - Chief Investigator - Parexel International Limited (UK)
Nathan Lee - Corresponding Applicant - Parexel International LLC (USA)
Mateo Delclaux Rodriguez-Rey - Collaborator - Parexel International Limited (UK)Outcomes:
eGFR, Blood Pressure, HbA1c, serum aldosterone
Description: Lay Summary
Over 8 million people in the UK are affected by high blood pressure. While there are several treatments available today the majority of studies for these products were done on adults or patients >55 years of age. Since this condition is not as common in children and adolescents the available medications are fewer and not well studies or testing in this specific demographic. However we expect the number of children with high blood pressure to increase in the future and as such we want to learn about this population and understand the effects of current and possibly future treatments for high blood pressure in children and adolescents. The aim of our study is to better understand how many children in the UK currently suffer from high blood pressure to help inform future interventions that can address this condition in children which is not currently well studied.
Technical SummaryThe aim of our study is to determine the prevalence of is pediatric uncontrolled/resistant hypertension, pediatric hypertension population refractory to a single anti-hypertensive agent, and primary hyperaldosteronism subpopulation.. This will help understand the full patient population that could potentially benefit from any upcoming interventions and policies that address the management of pediatric hypertension and pediatric aldosteronism in the UK.
Uncontrolled Hypertension definition = stable regimen of ⥠2 anti-HTN meds, from different therapeutic classes (at least one must be a diuretic) max tolerated dose for at least 4 wks prior to Screening
Resistant Hypertension definition = stable regimen of ⥠3 anti-HTN meds, from different therapeutic classes (at least one must be a diuretic), at max tolerated dose for at least 4 wks prior to Screening
Prevalence of hypertensive etiologies by age â timeframe (1 year and 3 year)â
1. < 6 years
2. > 6 years -
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A descriptive comparison of women in the CPRD Aurum Pregnancy Register compared to women whose pregnancy is recorded in linked data only. — Jennifer Campbell ...
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A descriptive comparison of women in the CPRD Aurum Pregnancy Register compared to women whose pregnancy is recorded in linked data only.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-27
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Alice Hinchliffe - Collaborator - CPRD
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Number of pregnancy episodes in primary care and non-primary care subdivided by the following demographic characteristics:
⢠Age
⢠Patient Level Socioeconomic Status
⢠Ethnicity
⢠BMI
⢠Smoking status
⢠Practice Level Urban/Rural classificationPregnancy characteristics
⢠Multiple birth
⢠Gravidity
⢠Parity
⢠Pregnancy OutcomeMorbidity Incidence
⢠Pre-pregnancy existing morbidities: Chronic Hypertension, Diabetes, Obesity, Depression, Anxiety, Epilepsy, Inflammatory Arthritis, Asthma, IBS, Migraine, Thyroid Disorders.
⢠Pregnancy induced morbidities: Gestational Diabetes, Pregnancy induced Hypertension including pre-eclampsia.Description: Lay Summary
Electronic health records (EHR) are a valuable tool for researchers to study the impact of exposure to diseases and drugs during pregnancy on mothers and their babies. The Clinical Practice Research Datalink (CPRD) is a database of primary care EHR data which is used for this purpose. However, it may be that only women who have contact with their GP during their pregnancy have a record of it in the CPRD. For this data to be useful it is important that researchers can understand how women with records of pregnancy in primary care data compare to the population of pregnant women within England. This study aims to describe characteristics such as age, socioeconomic status, ethnicity, and smoking status for women with pregnancy recorded in CPRD primary care data versus those women who only have a pregnancy record in other data sources such as hospital data. We will also look at how these two groups of women compare in terms of illnesses which are common in women of childbearing age and those which may be brought on by pregnancy.
Technical SummaryThe number of women whose pregnancies are recorded in the CPRD primary care data has been falling year on year since 2007. This descriptive cohort study aims to assess the representativeness of the CPRD Aurum Pregnancy Register by comparing women who have a pregnancy recorded in CPRD Aurum primary care data to those who only have a pregnancy record in linked data. The study will include all women between the ages of 11 and 49 in CPRD Primary Care data. Linked Hospital Episode Statistics data and Maternal Health Services Data will be used to ascertain pregnancy episodes that were not recorded in primary care. Pregnancy episodes will be matched to one another based on a +/- 12-week window and categorised according to which data sources they are recorded in. Follow-up periods will be restricted to those of the linked data used in each comparison. Tables and figures will then be generated to describe the women whose pregnancies are recorded in each of the lists. These will include information on demographics such as maternal age, socioeconomic status, ethnicity, smoking status and whether the woman attended an urban or rural practice. We will also look at characteristics of the pregnancy such as whether it is a multiple birth and whether it is the womanâs first pregnancy. Finally, we will describe the level of comorbidities present in each of the groups. The information generated by this study will help to strengthen future public health studies conducted using the CPRD Pregnancy Registers.
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Assessment of the Burden and Association of Cardiopulmonary Outcomes and Risks with COPD: Focus on Cardiopulmonary Related Risks (ABACOS-Risk) — Christopher Morgan ...
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Assessment of the Burden and Association of Cardiopulmonary Outcomes and Risks with COPD: Focus on Cardiopulmonary Related Risks (ABACOS-Risk)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-27
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Deven Patel - Collaborator - Astra Zeneca Inc - USA
Jonathan Patrick - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Michael Pollack - Collaborator - Astra Zeneca Inc - USA
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
cerebral infarction; haemorrhagic stroke; unspecified stroke; transient ischaemic attack; angina pectoris; acute myocardial infarction; subsequent myocardial infarction; complications after myocardial infarction; other acute ischaemic heart diseaseâ¯; chronic ischaemic heart disease; cardiomyopathyâ¯;type II diabetesâ¯;metabolic syndrome; hyperlipidemia; rheumatoid arthritis; atrial fibrillation; chronic kidney disease; heart failure; hypertension; disrupted sleep patterns/insomnia; percutaneous coronary intervention; coronary artery bypass grafting; angioplasty; endarterectomy; thrombectomy; low-density lipoprotein cholesterol; high-density lipoprotein cholesterol; Non-HDL-C, total cholesterol; triglycerides; haemoglobin A1C; and eosinophils), systolic blood pressure (SBP) and diastolic blood pressure (DBP), weight and body mass index
Description: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a group of common lung conditions including chronic bronchitis and emphysema that are characterised by difficulty breathing. COPD often gets worse over time. In the United Kingdom it has been estimated that COPD affects three million people leading to 1.4 million general practice consultations and approximately 30,000 deaths per year. In addition to the disease itself, COPD patients appear to be at greater risk of cardiovascular events such as stroke and heart attacks than people of a similar age who do not have COPD. In this study we want use the Clinical Practice Research Datalink to select patients with a diagnosis of COPD and estimate how many of them have cardiovascular disease, other related conditions and important risk factors such as high cholesterol and blood pressure at the time they are diagnosed. We will analyse these factors for all patients with COPD and also those newly diagnosed with the condition. We will also compare the number of people with each condition with controls, that is people from the same general practice of the same age and, gender who are not diagnosed with COPD. Understanding the presence of risk factors such as these in patients with COPD is of public health benefit as it may allow for the targeting of early-stage patients with personalised, optimised treatment. This could result in improved patient outcomes and reduce the number of times these patients visit their general practice or our admitted to hospital.
Technical SummaryChronic Obstructive Pulmonary Disease (COPD) causes shortness of breath, chest infections, and respiratory exacerbations. COPD patients are known to be at increased risk of cardiovascular (CV) and other respiratory events. This study aims to describe the presence of cardiopulmonary risk factors in COPD patients using the Clinical Practice Research Datalink (CPRD) Aurum database linked with Hospital Episode Statistics (HES) data and Office of National Statistics Index of Multiple Deprivation data. The primary objective of the study is to establish the prevalence and magnitude of individual morbidities representing cardiopulmonary risk factors. Secondary objectives will include: 1) assess the distribution, stability and variability of time varying risk factors during the study period; 2) assess the distribution, stability and variability of CV risk during the study period; 3) provide cardiopulmonary risk insights by COPD and non-COPD patients; 4) compare the prevalence or level of specific cardiopulmonary and CV risks in COPD vs. matched non-COPD patients and 5) describe general healthcare resource use (HCRU) and costs and compare these to controls. COPD cases will be selected between 01/01/2018 and 31/12/2019 with a COPD diagnosis recorded in either CPRD Aurum or HES. Patients will be categorised as incident and/or prevalent cases and risk factors will be ascertained in the previous 1, 2 and 3 years. To establish relative rates with non-COPD patients, age, gender and practice based controls will be matched at a ratio of 1:4. This study is primarily descriptive but comparison of risk scores will be tested by t-test or Mann-Whitney U test. HCRU activity and costs will be compared using a generalized linear models with Poisson/Gamma distributions Detecting high-risk patients creates the potential for earlier and more personalised treatment planning. This could reduce the occurrence of such events and create a lower healthcare resource use (HCRU) pathway for these patients.
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Chronic obstructive pulmonary disease(COPD)-, infection-, and inflammation-related factors in the moderation and mediation of the inhaled corticosteroids (ICS) and major adverse cardiovascular events (MACE) relationship, amongst people with COPD — Jennifer Quint ...
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Chronic obstructive pulmonary disease(COPD)-, infection-, and inflammation-related factors in the moderation and mediation of the inhaled corticosteroids (ICS) and major adverse cardiovascular events (MACE) relationship, amongst people with COPD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-06
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Anne Ioannides - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College LondonOutcomes:
Major adverse cardiovascular events (MACE) as a composite, as well as the individual subtypes thereof. MACE subtypes include:
- Acute coronary syndrome (ACS, including myocardial infarction),
- Ischaemic stroke (henceforth stroke),
- Arrhythmia,
- Heart failure (HF) hospitalisation, and
- Cardiovascular-specific death (CV-death).Description: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease where people experience symptoms such as cough, sputum and breathlessness. People with the condition are advised to stop smoking and are also sometimes given inhalers that help to open the airways and decrease inflammation. These inhalers can help to reduce symptoms and disease flare ups, known as exacerbations.
We know that people with COPD often have cardiovascular diseases such as heart attacks, and heart failure. What we do not know is that if by using some inhalers, we can decrease the risk of a person with COPD having a heart attack or heart failure for example. Using routinely collected electronic healthcare records we wish to understand whether some inhalers used to treat COPD reduce heart attacks and heart failure for example directly, or if the reason the heart attacks and heart failure are reduced is because the inhalers reduce the inflammation and disease flare ups that people with COPD get. This is really important to understand as it may change the way in which we prescribe inhalers for people with COPD.
Technical SummaryChronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disease, characterised by airway obstruction. People with COPD exist as a spectrum of traits and phenotypes, and they are not all alike in their disease characteristics or disease severity. COPD is treated (in addition to lifestyle interventions) using inhalers, namely bronchodilators (long-acting beta agonists [LABA] and long-acting muscarinic antagonists [LAMA]), and inhaled corticosteroids (ICS).
There is a well-established association between COPD and cardiovascular disease, include major adverse cardiovascular events (MACE). There is mixed evidence, however, to suggest that ICS may reduce MACE risk due to a reduction in the inflammatory mechanistic pathways that co-exist between COPD and cardiovascular disease. Whilst some post hoc analyses have found a cardioprotective effect of ICS, most observational research (and most meta-analyses and systematic reviews of all study types) have concluded that there is largely no association between ICS and MACE. It is possible that the mixed evidence is due to the heterogeneity in the COPD population, indicating that any relationship between ICS and MACE is indirect, and potentially mediated by respiratory factors.
Therefore, using Clinical Practice Research Datalink (CPRD) Aurum primary care data, linked with Hospital Episode Statistics (HES) secondary care data and Office of National Statistics (ONS) death data, we will conduct a cohort study between 1 January 2012 and up to the latest HES linkage availability, on people with a COPD diagnosis, prescribed some sort of LABA, LAMA, or ICS. We will compare MACE outcomes (including acute coronary syndrome, arrhythmia, ischaemic stroke, heart failure, or cardiovascular-specific death) between people prescribed ICS with people prescribed a long-acting bronchodilator in the absence of ICS directly, as well as indirectly through stratification and mediation analysis. We will consider mediators directly pertaining to COPD disease severity and phenotype, infection profile, and inflammatory burden.
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Alzheimer's disease patient diagnosis and disease management in England — Caroline Casey ...
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Alzheimer's disease patient diagnosis and disease management in England
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-11
Organisations:
Caroline Casey - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Amisha Patel - Corresponding Applicant - Adelphi Real World
Beth Dibben - Collaborator - Adelphi Real World
Lucinda Camidge - Collaborator - Adelphi Real World
Lucy Massey - Collaborator - Adelphi Real World
Niraj Patel - Collaborator - Eli Lilly & Co - UK
Nuha Brookfield - Collaborator - Eli Lilly and Company Ltd. (UK)Outcomes:
Sociodemographics (age, sex, geographic region, socioeconomic status, ethnicity, smoking status, education level, marital status, employment status) and clinical characteristics (family history of AD, Charlson Comorbidity Index (CCI), symptoms, body mass index (BMI), caregiver); time to pharmacological treatment; pharmacological treatment patterns (including off-label treatment use); frequency of follow-up appointments; time to receive diagnostic/imaging procedure; disease progression; mortality; HCRU and related costs; comorbid conditions; proportion of patients referred for and in receipt of biomarker confirmed diagnosis; time from initial presentation of AD symptoms to AD diagnosis
Description: Lay Summary
Alzheimerâs disease (AD) is an age-related disorder, characterised by memory loss that gets worse over time. Patients present with behavioural symptoms, including repetitive behaviour and confusion and ultimately struggle to perform normal activities required for daily living. These include cooking and washing, and so eventually, patients lose the ability to live independently and ultimately die with the disease. AD and dementia are the leading cause of death in the UK.
There is currently no cure for the disease, with current treatments aiming to promote independence, maintain function and treat symptoms. Newly developed treatments, amyloid targeting therapies (ATTs), target the protein that forms around braincells and is a hallmark of the disease, resulting in a slowing of disease progression. When they are rolled out across the UK (anticipated 2024), it will be advised that patients require an AD diagnosis by specific tests to receive them. Currently, most patients are not diagnosed with these tests and are diagnosed when the disease is more severe, leading to poorer patient outcomes. It is hoped that the launch of these treatments and subsequent changes in diagnosis guidelines will improve this.
This study aims to monitor and describe the change in patient care following their AD diagnosis. Patient demographics and characteristics, time waiting for treatments, frequency of follow-up appointments, treatments used, disease progression, death rates, moves to assisted living, and use of healthcare resources will be assessed over the next three years to help to identify ways in which care can be improved in the future.
Technical SummaryAim: To describe the current and future state of AD diagnosis and disease management in the National Health Service (NHS) in England. Results from this study will be used to assess how the standard of care for AD patients in England undergoes change for the effective introduction of amyloid targeting therapies (ATTs) as a treatment option.
Objectives: To describe: i) sociodemographic and clinical characteristics; ii) AD disease management; iii) disease progression, mortality and moves to assisted living; iv) healthcare resource utilisation (HCRU) and related costs; v) comorbid conditions; vi) proportion of patients with a biomarker confirmed diagnosis; vii) time from presentation of symptoms to diagnosis and disease progression in patients with AD.
Methods: Retrospective cohort study of adults newly diagnosed with AD within three successive time periods (waves) to capture how care changes during and after ATT launch. Patients will be indexed across a 6-month period and followed-up over a variable (6-12-month) period. The first wave will occur between March 2022 and March 2023, with the second and third waves likely to occur over the following two years without overlap. Primary (CPRD Aurum) and secondary (HES) will be used to assess aims and objectives.
Exposures: AD diagnosis and AD severity.
Outcomes: Sociodemographic and clinical characteristics, time to treatment, treatment patterns, frequency of follow-up appointments, time to receive diagnostic/imaging procedure, disease progression, mortality, moves into assisted living, HCRU and related costs, comorbid conditions, proportions of patients with biomarker confirmed AD diagnosis, time from initial presentation of symptoms to first AD diagnosis.
Data analysis: Frequencies and percentages will be reported for categorical variables. Counts, means, medians and standard deviations will be reported for continuous variables. Kaplan-Meier plots and associated statistics will be reported for time-to event variables. Incidence rate will be calculated by dividing frequency of events by person time at-risk.
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Are people who die with multiple long-term conditions-multimorbidity considered for a palliative approach to care in the last year of life? A retrospective observational study — Barbara Hanratty ...
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Are people who die with multiple long-term conditions-multimorbidity considered for a palliative approach to care in the last year of life? A retrospective observational study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Barbara Hanratty - Chief Investigator - Newcastle University
David Sinclair - Corresponding Applicant - Newcastle University
Elizabeth Westhead - Collaborator - Newcastle University
felicity dewhurst - Collaborator - Newcastle University
Laurie Davies - Collaborator - Newcastle UniversityOutcomes:
Use of palliative care in the last year of life for patients with MLTC-M
Secondary outcome: Use of DNACPR in the last year of life for patients with MLTC-M
Description: Lay Summary
Treatments for diseases are improving so people live for longer with more health problems. Most deaths in the UK are amongst older people, a majority of whom are dying with multiple long-term conditionsâmultimorbidity (MLTC-M), i.e. more than one long-term disease. However, we donât fully understand how people with MLTC-M use health services as they approach the end of their lives.
We need to understand this better, so that we can support patients to manage their symptoms, live well and die well. Indeed, when people near the end-of-life, this can indicate that a different approach to healthcare is needed. This might involve thinking about the personâs priorities or preferences for healthcare, or streamlining the number of appointments they must attend. We also need to find out if people who die with MLTC-M are being recognised as approaching the end-of-life, to check if we are offering them the most appropriate care.
The Clinical Practice Research Datalink (CPRD) may allow us to understand these issues, as CPRD routinely collates patient data from GP practices across the UK, and some of the information describes the care that patients receive in the last year of life.
We will investigate whether older adults who died with MLTC-M are being recognised as nearing the end-of-life. This may inform policy and practice, to help ensure that future older populations receive appropriate care when they approach the end of their lives.
Technical SummaryThe receipt of palliative care is important for quality of life. Growing numbers of older people are dying with multiple long-term conditions-multimorbidity (MLTC-M), but little is known about the healthcare they receive. Therefore, we aim to examine whether people with MLTC-M are recognised as requiring a palliative approach to care prior to their death in their last year of life.
We will conduct a retrospective observational study of electronic primary care records using CPRD GOLD. Our population will be research acceptable patients who died in the year 2023 at or older than the age of 50, with a minimum of 365 days between their CPRD registration date and date of death. Data on the last 12 months of their lives will be examined.
Our exposure of interest is MLTC-M, which we will firstly define as a binary variable â having malignant multimorbidity (e.g. cancer and at least one other disease) or non-malignant multimorbidity (e.g. an advanced progressive condition other than cancer, plus at least one other disease). Our outcome of interest is palliative care identification and the use of DNACPR (Do Not Attempt Cardiopulmonary Resuscitation), which may be considered best practice for terminally ill patients. We will use descriptive tables, data visualisation and logistic regression to explore patterns between multiple long-term conditions and these variables in the last year of life.
We will examine practice location (rural or urban), and index of multiple deprivation, and evaluate if these variables have any association with palliative care identification.
Findings may highlight inequitable palliative care provision, which may inform the development of targeted interventions.
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Multiple Long-term Conditions And Prematurity Study: A cohort study using CPRD and linked hospital data investigating the relationship between preterm and multiple long-term conditions from 0-10 years of age in children born 2000-2014 in England — Tim van Hasselt ...
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Multiple Long-term Conditions And Prematurity Study: A cohort study using CPRD and linked hospital data investigating the relationship between preterm and multiple long-term conditions from 0-10 years of age in children born 2000-2014 in England
Datasets:GP data, Count of identified chronic conditions across primary care, HES APC and OP episodes from 0-10 years; MLTCs - binary variable: 0/1+ long-term condition; prevalence of MLTCs at yearly intervals (e.g. 0-1 years, 0-2 years, etc); incidence of onset of MLTCs at yearly intervals (e.g. 0-1 years, 1-2 years, etc); chronological age at onset of recorded MLTCs); frequency of primary care consultations per year; frequency of accident and emergency attendance per year; frequency of outpatient appointments per year; frequency of inpatient admissions per year; total duration of inpatient admissions per year; total calendar days with healthcare interaction per year
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-05
Organisations:
Tim van Hasselt - Chief Investigator - University of Leicester
Tim van Hasselt - Corresponding Applicant - University of Leicester
- Collaborator -
Clare Gillies - Collaborator - University of Leicester
David Lo - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Lisa Szatkowski - Collaborator - University of Nottingham
Lucy Smith - Collaborator - University of Leicester
Sarah Seaton - Collaborator - University of Leicester
Vibhore Prasad - Collaborator - University of NottinghamOutcomes:
Count of identified chronic conditions across primary care, HES APC and OP episodes from 0-10 years; MLTCs - binary variable: 0/1+ long-term condition; prevalence of MLTCs at yearly intervals (e.g. 0-1 years, 0-2 years, etc); incidence of onset of MLTCs at yearly intervals (e.g. 0-1 years, 1-2 years, etc); chronological age at onset of recorded MLTCs); frequency of primary care consultations per year; frequency of accident and emergency attendance per year; frequency of outpatient appointments per year; frequency of inpatient admissions per year; total duration of inpatient admissions per year; total calendar days with healthcare interaction per year
Description: Lay Summary
The survival of preterm-born babies (born before 37 weeks of pregnancy) has improved in recent decades. However, some preterm-born children may have ongoing health issues after they go home from neonatal care, and these may continue into childhood.
Technical Summary
Some adults have multiple long-term health conditions (MLTCs, also known as multimorbidity), and research shows that this can lead to poorer general health and quality of life.
Researchers are now looking at children with MLTCs, for example children with both asthma and autism. However, we do not know if preterm birth increases the risk of having MLTCs, and how often preterm-born children with MLTCs need to see their general practitioner (GP) or go to hospital. Parents of preterm-born children told us they went to their GP with âa list of conditionsâ their child had, and became âspecialistsâ themselves.
We will use anonymised NHS data on visits to GPs and hospital of children aged up to 10 years, to find out whether children who are born preterm have more MLTCs, what these conditions are, and when they develop. We will focus on children born between 2000 and 2014 living in England. We will also look at whether a childâs ethnicity or the level of poverty in their neighbourhood increases the risk of them developing MLTCs.
This study will provide information to allow families to better understand the health needs their preterm-born child may have after going home from neonatal care, and to help clinicians and NHS managers plan health services.Every year in the UK there are 60,000 preterm births (before 37 weeks of pregnancy), which represents 8% of live births. Despite increasing survival of the most preterm babies in recent decades, the incidence of complications such as chronic lung disease are increasing. There is evidence that preterm-born children have greater healthcare utilisation than children born at term (from 37 weeks), for example in my PhD I demonstrated increased rates of paediatric intensive care admission for these children until the age of two.
The importance of multiple long-term health conditions (MLTCs) in children is now being recognised. Up to 10% of children have more than one chronic health condition, impacting on later health, education, and employment.
To our knowledge no studies have examined MLTCs in preterm-born children in early childhood. Previous studies of MLTCs examined either primary care or secondary care records, rather than using both. The Clinical Practice Research Datalink (CPRD) is derived from routinely-collected primary care data, with linked secondary care and pregnancy data, allowing researchers to follow patients across the healthcare system.We aim to investigate the impact of preterm birth on the development of MLTCs in childhood, through these objectives:
- Create CPRD cohort (CPRD Aurum and Gold, linkages: pregnancy, mother-baby, HES APC, OP, A&E), children aged 0-10 years, comparing preterm and term-born children.
- Co-design a definition of MLTC for CPRD using Delphi process: families, preterm-born adults, and healthcare professionals
- Describe incidence and prevalence of MLTCs in preterm and term-born children across primary/secondary healthcare records
- Use statistical models to examine the relationship between preterm birth and MLTC:
multivariable logistic regression, Poisson regression, multistate model (transitions between states: healthy, 1 condition, MLTC, died); adjusting for other covariates (e.g. sex, ethnicity, deprivation)
- Describe healthcare usage by preterm-status and MLTCs across primary and secondary care
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The association between ever and never having attended diabetes self-management education programmes, hospital admission rates and mortality in type 2 diabetes: A cohort analysis using data from the UK Clinical Practice Research Datalink. — John Wilding ...
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The association between ever and never having attended diabetes self-management education programmes, hospital admission rates and mortality in type 2 diabetes: A cohort analysis using data from the UK Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-06
Organisations:
John Wilding - Chief Investigator - University of Liverpool
Gemma Lewis - Corresponding Applicant - University of Liverpool
David Hughes - Collaborator - University of Liverpool
Greg Irving - Collaborator - University of Liverpool
Kevin Hardy - Collaborator - NHS England
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
All-cause hospitalisation; Cause-specific hospitalisation; All-cause mortality; Cause-specific mortality; In-hospital-mortality; Metabolic HbA1c; MACE-3P (cardiovascular death, non-fatal MI, non-fatal stroke);
Description: Lay Summary
Diabetes, a condition characterised by high blood sugars is the leading cause of disability in England for men, and second for women. People with diabetes are more likely to be admitted to hospital, stay for a longer period, and die at a younger age when compared to the general population. Without proper care diabetes can result in life changing complications. Everyone with diabetes should be offered diabetes self-management education (DSME) which is clinically proven to support people with type 2 diabetes to reduce high blood sugars, stay healthy and live well. Despite clinical guidelines recommending DSME only a small number of people with type 2 diabetes have ever attended and this has not improved over the last 10 years. Research looking at the impact of attending DSME on hospital admissions or early death is limited. Our research will investigate if attending DSME is linked to a reduced risk of hospitalisation and premature mortality. This study will describe the number and cause of hospitalisations and deaths in patients with type 2 diabetes who have ever or never had DSME over a 10-year period in England. Our findings will provide important insights into the importance and effectiveness of nationally recommended DSME and may ultimately reduce the high costs associated with complications and inpatient stays.
Technical SummaryType 2 diabetes is associated with an unexplained persistent excess gap in hospital admissions and mortality. Whilst a decline in diabetes related morbidity and mortality is evidenced within the literature, this has been accompanied by an unexplained diversification of causes requiring preventative and clinical strategies. Structured diabetes self-management education (DSME) is internationally recommended for all people with type 2 diabetes and is designed to support patients in self-managing their condition and prevent associated long-term complications.
There is mixed evidence to suggest DSME attendance may be helpful in reducing hospital admissions and premature mortality in type 2 diabetes. Available literature often does not have admissions or mortality as the primary outcome measure reporting outcomes post-hoc, have short follow up periods, smaller samples and are inconsistent in the type of education being assessed. The role of structured DSME on hospital admissions and premature mortality in the UK is therefore unclear.
The DSME IMPACT study will use data from the UK Clinical Practice Research Datalink (CPRD) with two separate analyses. Analysis 1 will review the association of ever or never having attended DSME on hospital admissions. Analysis 2 will specifically consider the association between ever or never having attended DSME and mortality. The rate of all cause and cause-specific hospitalisations, mortality and MACE-3P will be calculated.
Individuals aged 18 years or older with type 2 diabetes and registered to an English GP practice between 29.3.11-29.3.21 will be identified from the UK CPRD and linked to Hospital Episode Statistics Admitted Patient Care data (HES APC), Office for National Statistics (ONS) death registration data and patient level Index of Multiple Deprivation (IMD) deciles. This population will be followed up over time through serial cross sections. Cox proportional hazard regression and time to event modelling will be used, adjusted a priori for relevant cofounding variables.
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Clinical management and health outcomes of people diagnosed with a personality disorder and those who have harmed themselves: a multi-phase study. — Sarah Steeg ...
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Clinical management and health outcomes of people diagnosed with a personality disorder and those who have harmed themselves: a multi-phase study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-11
Organisations:
Sarah Steeg - Chief Investigator - University of Manchester
Jessica Hackney - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Faraz Mughal - Collaborator - Keele University
Navneet Kapur - Collaborator - University of Manchester
Paul Moran - Collaborator - University of Bristol
Pearl Mok - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
Phase 1 - Prevalence of personality disorder diagnoses; prevalence of personality disorder-related codes; incidence of self-harm; prevalence of personality disorder AND self-harm.
Phase 2 - Number of GP appointments; referral to mental health services (yes/no); quantity and type of prescriptions for psychotropic medication; Usual Provider of Care index; Bice-Boxerman index.
Phase 3 - Death from any external cause; death by suicide; death by homicide; accidental deaths; rate of hospitalisation.
Phase 4 - Risk of self-harm; risk factors for self-harm.
Description: Lay Summary
Personality disorder is a term used for a group of conditions that share similar symptoms, including difficulties with relationships and emotions. People diagnosed with a personality disorder often experience stigma from the public, and from healthcare professionals and services. This may further worsen the mental health of these patients and poorly affect the healthcare that they receive. People with a personality disorder are at higher risk of self-harm than the general population. Self-harm is similarly stigmatised, and those who self-harm also have poorer health outcomes. Therefore, we expect that patients with a diagnosis of a personality disorder who also self-harm will have less positive experiences than patients experiencing either on its own, due to additional stigma.
Our study aims to:
⢠Examine how often personality disorder and self-harm occur over time, including by age, sex, ethnicity, and deprivation.
⢠Explore general practice (GP) care of people diagnosed with a personality disorder and who self-harm, including the number of GP appointments, medication, and referrals to mental health services.
⢠Explore whether these groups have different rates of hospitalisation, suicide, homicide, and accidental death compared to members of the general population.
⢠Determine what may increase the likelihood of self-harm in those with a diagnosis of personality disorder.This research will generate new knowledge that will inform initiatives to enhance care for patients with a personality disorder and who self-harm.
Technical SummaryAims:
1. Examine temporal trends in prevalence of personality disorder (PD) diagnosis, incidence of self-harm, and prevalence of a record of both in general practice records, and demographic characteristics of these groups.
2. Explore general practice management of those with a PD diagnosis and who have self-harmed, including pharmacological management, referrals to mental health services, consultation frequency, and continuity of care.
3. Examine rates of hospitalisation and of deaths from external causes in those with PD and who have self-harmed compared with the general population.
4. Estimate relative risks and risk factors for self-harm in those with a PD diagnosis.Each aim represents a distinct phase of the study, which will use data from CPRD Aurum. Phases 1 and 2 will utilise a descriptive cohort design, while phases 3 and 4 will utilise matched cohorts to produce Coxâs Proportional Hazards models. Phase 4 will include a nested case-control study, to estimate the risks of self-harm. We propose utilisation of linked datasets: Hospital Episode Statistics (HES) Admitted Patient Care (APC) data, patient postcode deprivation measures, and the Office for National Statistics (ONS) death registration data.
Populations of interest: People with a PD diagnosis, people with PD-related codes, people with a record of self-harm, and people with both PD and self-harm recorded. The study will involve a sensitivity analysis of PD-related codes and PD diagnoses. The results of this analysis will inform the study population used in subsequent phases (i.e. whether those with PD-related codes are included in the PD population). If cells would contain
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A real-world evidence study describing characteristics of patients receiving a cardiovascular disease risk assessment in primary care in the UK between 2013 and 2023 — Jay Were ...
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A real-world evidence study describing characteristics of patients receiving a cardiovascular disease risk assessment in primary care in the UK between 2013 and 2023
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-11
Organisations:
Jay Were - Chief Investigator - Parexel International Limited (UK)
Mateo Delclaux Rodriguez-Rey - Corresponding Applicant - Parexel International Limited (UK)
M. Natalia Stelmaszuk - Collaborator - Parexel International Limited (UK)
Sophie Young - Collaborator - Parexel International INC
Xinyu Yang - Collaborator - Parexel International Limited (UK)Outcomes:
QRISK score; QRISK category (high, intermediate, low); age; sex; region; ethnicity; BMI; BMI category (healthy, underweight, overweight, obese, severely obese); smoking status; history of lipid testing; frequency of lipid testing; comorbidities.
Description: Lay Summary
The National Health Service (NHS) Health Check was introduced in 2009 to help healthcare workers assess and manage the risk of heart and blood vessel-related health issues in seemingly healthy people in England. This free check-up looks at a person's overall health to see if they might be more likely to develop certain health problems.
People between 40 and 74 years old who go for an NHS Health Check should have their risk of heart and blood vessel problems calculated using a tool called QRISK. QRISK is a way to figure out how likely someone is to have a heart attack (when blood flow to part of the heart decreases or stops) or stroke (when blood flow to part of the brain is blocked or reduced) in the next 10 years. Doctors and researchers created QRISK using information from many thousands of family doctor offices across the country.
This study aims to look at the group of people who have had their heart and blood vessel risk checked using QRISK in the last 10 years. It will describe how this group has changed over time. The study will provide information on how QRISK is being used in real life across England and might help shape future health policies.
Technical SummaryThe National Health Service (NHS) Health Check was introduced in 2009 to encourage healthcare professionals to measure and manage the cardiovascular risk burden in the apparently healthy population in England. NHS Health Check consists of a free check-up of an individualâs overall health, with the aim to inform the individual of whether they are at a higher risk of getting certain health problems including heart disease, diabetes, kidney disease and stroke. The NHS Health Check programme in England advises that everyone aged 40â74 years, who has not already been diagnosed with cardiovascular disease (CVD), diabetes, or chronic kidney disease should be assessed for CVD risk using the QRISK tool every 5 years.
This is a descriptive retrospective observational cohort study of patients that have been newly assessed for CVD risk using the QRISK tool in England between 2013 and 2023. The aim of the study is to characterize the patient population and to describe changes in the population profile over time. The study will examine patient demographics including age, sex, region and ethnicity, and clinical characteristics including QRISK score, body mass index (BMI), smoking status, history of lipid testing, and comorbidities. All analysis will be conducted using CPRDâS Aurum primary care data. Patients will be assessed at their first ever QRISK score; a 12-month baseline period prior to the date of QRISK assessment will be used to evaluate the patient's characteristics. The study will provide information on the real-world use of the QRISK score in England over time and offer an opportunity to inform future health policy.
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Generating baseline metrics for the assessment of the UK Rare Diseases Framework. — Christopher Morgan ...
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Generating baseline metrics for the assessment of the UK Rare Diseases Framework.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-07
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Craig Currie - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Vishnav Pradeep - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence; time to diagnosis; symptoms; utilisation of clinical genetics; primary care contacts; inpatient admissions; outpatient appointments; mortality...
Description: Lay Summary
A rare disease is classified as one which affects less than one in 2,000 people. Over 7,000 conditions meet this criterion and thus, whilst rare individually, collectively they impact an estimated 3.5 million people. Most of these conditions are present from birth but others are acquired later in life. Conditions present at birth tend to manifest during childhood and often have high mortality. They place a huge burden on patients, their families and healthcare services. The government backed UK Rare Diseases Framework (UKRDF) aims to improve the lives of patients with rare diseases by optimising time to diagnosis and improving services and treatment. The RareCare Study is a collaboration of healthcare professionals, researchers, and patient advocacy groups funded by the National Institute for Healthcare Research (NIHR) to evaluate the impact that the UKRDF has on patientsâ lives. The RareCare study will collect a wide range of information including that from electronic databases and patient interviews. As part of this, our study will assess how useful the Clinical Practice Research Datalink and linked Hospital Episode Statistics is in being able to select patients with the most common rare diseases. We will then assess how many people have each condition and other factors including the time it takes to be diagnosed, the age of people when diagnosed and whether early versus later diagnosis affects how often patients use healthcare services. This data will be important in assessing the impact that the UKRDF has on improving the lives of patients with rare diseases.
Technical SummaryWhilst an individual rare disease impacts relatively few patients, there are 7,000 rare diseases collectively affecting 3.5 million patients. Many of these diseases are particularly severe but time to diagnosis and subsequent management can be sub-optimal. The UK Rare Diseases Framework (UKRDF) aims to improve the lives of patients with rare diseases by reducing diagnosis times and improving access to services and treatment. The RareCare Study will evaluate the success of the UKRDF. As part of this, we will characterise the baseline metrics of the most common rare diseases. The study will use the Clinical Practice Research Datalink (CPRD) Aurum database linked with Hospital Episode Statistics (HES) data and Office of National Statistics Index of Multiple Deprivation data. The primary objective is to establish whether each disease can be captured within the database. Secondary objectives are to characterise: i) prevalence ii) age at diagnosis, iii) presence of genetic testing iv) variation in âearlyâ versus âlateâ diagnosis on resource use and outcomes v) initial symptoms vi) resource use around diagnosis vii) geographic variations. Code lists for each condition will be created and patients selected from both the CPRD Aurum and HES admitted patient care datasets. Due to the lack of coding granularity, particularly the ICD-10 classification, additional criteria such as biochemical results will be used if appropriate. The ability to capture each disease will be assessed and prevalence estimated. Age and characteristics of patients at diagnosis will be presented. Resource use at, and subsequent, to diagnosis, and clinical outcomes will be compared with age and gender matched controls. This study will assess how useful CPRD is in estimating these metrics and provide data to benchmark changes in practice following the implementation of the UKRDF to evaluate how successful it is in improving the lives and management of patients with rare diseases.
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Dihydropyridine Calcium Channel Blockers for the Prevention of Dementia in Patients with Hypertension — Samy Suissa ...
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Dihydropyridine Calcium Channel Blockers for the Prevention of Dementia in Patients with Hypertension
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-27
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Collaborator - McGill University
James Brophy - Collaborator - McGill University
Janie Coulombe - Collaborator - University Of Montreal
Kyle Johnson - Collaborator - McGill University
Rhian Touyz - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Sarah Beradid - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Dementia diagnosis. List of relevant diagnostic codes are provided in Appendix 1.
Description: Lay Summary
Patients with high blood pressure, or hypertension, have an increased risk of dementia, a term referring to a range of aberrant brain changes associated with progressive cognitive impairment such as memory problems and eventual loss of independence in daily activities. However, reducing blood pressure with antihypertensive drugs has not been consistently associated with a reduced risk of dementia. Some antihypertensive drugs named dihydropyridines are of particular interest because, aside from lowering blood pressure, they may have a direct effect on the brain and may therefore have an additional direct protective effect against dementia. Specifically, some dihydropyridines easily penetrate into the brain while others do not, suggesting that the former may have a direct neuroprotective effect. Thus, we will assess whether individuals who are treated with dihydropyridines easily penetrating into the brain have a decreased risk of dementia compared with individuals treated with other dihydropyridines. To perform this study, we will use the Clinical Practice Research Datalink (CPRD). We will select all patients with hypertension treated with dihydropyridines and determine whether those treated with dihydropyridines penetrating easily into the brain are less frequently diagnosed with dementia compared with those treated with other dihydropyridines. The proposed research project will provide information on the potential benefit of these drugs to prevent dementia. If we show that these drugs are beneficial, they could be prescribed preferentially to patients at high risk of dementia and could improve the prognosis of these patients.
Technical SummaryArterial hypertension is a major contributor to cognitive impairment and dementia, given its high prevalence and strong association with both aging and dementia. Thus, controlling blood pressure (BP) with antihypertensive medications (AHMs) represents an opportunity for the prevention of dementia. There is emerging evidence that dihydropyridine (DHP) calcium channel blockers (CCBs), commonly used first-line AHMs, may have neuroprotective effects. Specifically, some DHPs easily cross the blood-brain-barrier (BBB), while others such as amlodipine do not, suggesting that the former may have a direct neuroprotective effect compared with the latter. Our primary objective is therefore to assess whether use of BBB-crossing DHPs is associated with a decreased risk of dementia compared with non-BBB-crossing DHPs among patients with hypertension. Secondary objectives include assessing whether the risk depends on duration of use, age, sex, history of various comorbidities, and individual drugs.
We will use the Clinical Practice Research Datalink to assemble a cohort of patients newly treated with BBB-crossing or non-BBB-crossing DHPs between 1995 and 2021. Marginal structural Cox models will be fit to estimate hazard ratio and 95% CI of dementia associated with use of BBB-crossing DHPs compared with non-BBB-crossing DHPs. We will conduct secondary analyses to assess effect measure modification and sensitivity analyses to assess the robustness of our results. Our population-based study will provide critical information on the potential decreased risk of dementia associated with BBB-crossing DHPs and whether risk is associated with patient or DHP use characteristics.
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Evaluating cardiovascular disease risk in people with diabetes remission and relapse in a UK based- population: a real- world retrospective cohort study. — Claire Lawson ...
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Evaluating cardiovascular disease risk in people with diabetes remission and relapse in a UK based- population: a real- world retrospective cohort study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-27
Organisations:
Claire Lawson - Chief Investigator - University of Leicester
YANAN SONG - Corresponding Applicant - University of Leicester
Emer Brady - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of LeicesterOutcomes:
(1) Prevalence of T2D remission
(2) Frequency of diabetes relapse
(3) Identify key patient, clinical and treatment factors associated with T2D- remission and relapse
(4) Quantify CVD risk (incidence and time to first- index of CVD, incidence of and time to first diagnosis of major adverse cardiovascular events (MACE) and time to fatal and non-fatal CVD hospital admission, in people in T2D-remssion and those that relapse, compared to people with persistent T2DDescription: Lay Summary
Diabetes is a condition where the body cannot keep blood sugar at a normal level. When blood sugar levels are high for long periods of time, blood vessels and cells of the heart can become damaged, which can lead to a heart attack and even death. Adults with diabetes are two to three times more likely to develop heart disease. Recent studies have shown that the blood sugar levels in some people with diabetes can recover to normal without any diabetes medication. This can happen when a large amount of weight is lost through different methods. When this happens, the condition is called diabetes âremissionâ which can last or may change back to diabetes again, which is called ârelapseâ. What we donât know is how being in âremissionâ or ârelapseâ affects the chances of developing heart diseases, compared to the people who continue to have diabetes. In this study we aim to: 1)Find out how many people in the UK are in or have been in diabetes remission and how frequently relapse happens. 2)Compare the health (blood pressure, cholesterol level, other illnesses and treatments) of people in remission, relapse and those who continue to have diabetes. 3)Explore what things increase the chances of developing heart disease in people with remission or relapse and how these might be different to people who continue to have diabetes. This study is important in helping us understand what increase the chances of developing heart disease in people in diabetes remission and those who relapse.
Technical SummaryBackground
T2D-remission, achieved without clinical intervention such as bariatric surgery, is a relatively new phenomenon. [1] There is growing evidence that remission of T2D is feasible following significant weight-loss, by intensive lifestyle interventions [2-4] and there is emerging evidence of remission induced in people with new-onset T2D via intensive pharmacological treatment.[5, 6] Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people living with T2D,[7] who develop CVD approximately 15 years earlier than their non-T2D counterparts.[8]However, the medium and long-term impact of remission on heart health and mortality are unknown and no clinical guidelines for the treatment or management of those in remission exist in the UK.
Design
Retrospective cohort design
Methods
Phase 1: Patients, aged ⥠18years, with a new diagnosis of T2D without prior CVD, will be explored in CPRD and Hospital records. Within this group the incidence and timing of remission according to patient factors, clinical characteristics (treatments and morbidities) and year of diabetes diagnosis will be investigated.
Phase 2: In patients with a first remission, we will investigate the frequency of relapse over time, time to first relapse and risk factors of relapse.
Phase 3: The association between remission, relapse and the incidence of CVD and major adverse cardiovascular events will be estimated, and compared to those with persistent diabetes.
Outcomes: It is important to gather current evidence to the epidemiology and clinical characteristics of diabetes remission and remission-relapse and to quantify their association with CVD. This data will inform clinical guidelines for the prevention and management of CVD in this under-researched growing patient population.
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Incidence and prevalence of metabolic dysfunction associated fatty liver disease (MAFLD) and metabolic dysfunction associated steatohepatitis (MASH) and associations with liver, cardiovascular and renal outcomes in primary care electronic health records — William Alazawi ...
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Incidence and prevalence of metabolic dysfunction associated fatty liver disease (MAFLD) and metabolic dysfunction associated steatohepatitis (MASH) and associations with liver, cardiovascular and renal outcomes in primary care electronic health records
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-01
Organisations:
William Alazawi - Chief Investigator - Queen Mary University of London
Huei-Tyng Huang - Corresponding Applicant - Queen Mary University of London
Catriona Chaplin - Collaborator - Queen Mary University of London
Michael Hewitt - Collaborator - Queen Mary University of London
Naveed Sattar - Collaborator - University of GlasgowOutcomes:
Primary outcomes:
1) Incidence and point prevalence of MAFLD/MASH;
2) Clinical and demographic characteristics of MAFLD/MASH patients and how these changed over time;
3) Risks between MAFLD/MASH and liver-related outcomes, such as cirrhosis and HCC;
4) Risks between MAFLD/MASH and non-liver related outcomes, such as CVD and CKD;Secondary outcomes:
1) The association between MAFLD/MASH with non-invasive tests or fibrosis scores (e.g. Fib-4);
2) The association between MAFLD/MASH and early intervention strategies (e.g. liver biopsy);
3) Risk scoring for MAFLD/MASH progressing to liver/non-liver related outcomes;
4) Comparing those associations and identifying causal relationships between factors and outcomesDescription: Lay Summary
Metabolic dysfunction- associated fatty liver disease (MAFLD) is the most common liver disease worldwide, affecting around 25% of the general Western population. Its prevalence is higher in individuals with obesity (up to 90%). While most cases involve harmless fat buildup in the liver, a smaller portion (10-20%) can develop into a more serious condition called metabolic dysfunction- associated steatohepatitis (MASH). MASH involves inflammation and damage to liver cells, and can eventually lead to scarring (fibrosis), hardened liver (cirrhosis), liver failure, and even liver cancer. Here's the thing: MAFLD/MASH not only affects the liver, but also increases the risk of heart and kidney diseases. Unfortunately, our current understanding of MAFLD/MASH comes from smaller studies with limited patient groups. This study aims to use a large, real-world UK population database to gain a clearer picture of:
Technical Summary
1. How many people have MAFLD/MASH in the UK, and is this number changing? We'll look at trends over time, including who's most affected and how severe the disease is.
2. What are the long-term consequences? We'll track how MAFLD/MASH progresses, focusing on liver problems such as liver cancer.
3. Does MAFLD/MASH increase the risk of other diseases? We'll study the link between MAFLD/MASH and heart and kidney disease, investigating the impacts of MAFLD/MASH.
This large-scale study will provide valuable insights into the growing impact of MAFLD/MASH, who's most at risk, and how the disease progresses over time. This information will help healthcare professionals develop better strategies to manage this complex condition.This study will extract data on diagnoses made between 2004-2022, and will investigate the UK population data using CPRD. Our group had done similar research using multiple European databases, and in this research, we will focus on the UK population. Patients aged â¥18 with a recorded diagnosis of Metabolic dysfunction- associated fatty liver disease (MAFLD) or metabolic dysfunction- associated steatohepatitis (MASH) will be included, excluding those with < 1-year follow-up, pre-existing liver disease, or alcohol abuse. Demographic information, lifestyle factors, relevant comorbidities (e.g., type 2 diabetes, hypertension), and treatment history will be extracted for patients with a diagnosis of MAFLD/MASH within the CPRD dataset. Laboratory values (e.g., liver enzymes, lipid profile, haemoglobin A1C (HbA1c), creatinine) around diagnosis, body mass index, ethnicity, and blood pressure measurements will also be collected. A matched cohort study will be conducted. MAFLD/MASH patients diagnosed before 01/01/2023 will be matched 1:100 to controls without MAFLD/MASH, based on practice site, age, sex, and recent visit. Patients with pre-existing cirrhosis, decompensation, or hepatocellular carcinoma (HCC) will be excluded. Patients will be followed from the index date until the earliest of: cirrhosis, decompensation, HCC, MASH diagnosis, study end, loss to follow-up, or death. Incident diagnoses of these events will be captured. For cardiovascular disease (CVD) and chronic kidney disease (CKD) outcomes, patients with pre-existing diagnoses will be excluded. Incidence and prevalence estimates will be calculated and compared across calendar years, age groups, and sex. Potential limitations include undiagnosed MAFLD/MASH in the matched group, which will be mitigated by the large sample size and sensitivity analyses. This large-scale, real-world study will provide robust estimates of MAFLD/MASH epidemiology, risk factors, and long-term outcomes, informing better management strategies for clinical usage.
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Trends in the Utilization and Persistence on Adjuvant Hormonal Therapy among Women with Early Invasive Breast Cancer in the United Kingdom, 2004 to 2023 — Samy Suissa ...
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Trends in the Utilization and Persistence on Adjuvant Hormonal Therapy among Women with Early Invasive Breast Cancer in the United Kingdom, 2004 to 2023
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Sara Soldera - Collaborator - McGill University
Stephen Ogbodo - Collaborator - McGill UniversityOutcomes:
1. Period prevalence of adjuvant hormonal therapy utilization (overall and for tamoxifen and SERMs separately) in each year between 2004 and 2023, and further disaggregated by age groups and specific drugs.
2. First prescription of adjuvant hormonal therapy (tamoxifen or AIs) and the baseline characteristics of women newly initiating treatment with these drugs.
3. Temporal trends in the average duration of therapy and persistence on treatment.Description: Lay Summary
Breast cancer is a leading cause of cancer-related deaths among women worldwide. Most cases of breast cancer are effectively treated using certain hormonal medications, in addition to cancer surgery. Two groups of drugs are currently approved for this purpose: tamoxifen and aromatase inhibitors. Clinical guidelines informing the choice between these two drug classes have changed over time, in response to what we know about their effectiveness and safety. This study will describe the trends in the use of hormone treatment for breast cancer among women in the United Kingdom, between 2004 and 2023. The results will show how clinical practice has responded to evidence and treatment guidelines over time, and describe how these drugs are currently prescribed in the United Kingdom. Furthermore, the study will describe how long women generally remain on these drugs before stopping treatment, as this is an important driver of treatment success. Ultimately, the study results will guide physicians, support public health resource planning, and inform the design of vital health research in this area.
Technical SummaryBreast cancer is a leading cause of cancer-related mortality among women worldwide. About 75% of all breast cancers are hormone-receptor positive and are treated using oral antihormonal medications, which inhibit the stimulative effect of oestrogen on breast cancer cells. Two drug classes are currently approved for this purpose: selective oestrogen receptor modulators (SERMs)âprimarily tamoxifenâand aromatase inhibitors (AIs), including anastrozole, letrozole and exemestane. Clinical guidelines informing the choice between these two drug classes have evolved over time in response to evidence regarding their comparative effectiveness and safety. This study will comprehensively describe the trends in the use of adjuvant hormone therapy for early breast cancer among women in the United Kingdom (UK), between 2004 and 2023. The study has three main objectives; to: i) describe the trends in adjuvant hormone therapy use; ii) describe the characteristics of women prescribed AIs or tamoxifen; and iii) assess trends in persistence on therapy. For the first objective, we will separately estimate the annual prevalence of use of AIs and tamoxifen, further disaggregated by age group and specific drugs. We will present these rates graphically to highlight utilization trends over time. Secondly, to better understand the patient populations, we will describe the characteristics (age and comorbidity profiles) of women beginning treatment with AIs or tamoxifen. Lastly, we will describe the trends in the average duration and persistence on adjuvant hormone treatmentâan important predictor of breast cancer outcomes. To assess persistence, we will use the Cumulative Incidence Function method to estimate the probability of a first treatment discontinuation of at least 90 days, accounting for competing risk of death from any cause, over an assumed five-year period of intended treatment. Taken together, the study results will guide physicians, support public health resource planning, and inform the design of epidemiologic research in this area.
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Observational study designs and analytical options for the evaluation of safety of multi-dose vaccines: An application to COVID-19 and rotavirus vaccines. — Ian Douglas ...
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Observational study designs and analytical options for the evaluation of safety of multi-dose vaccines: An application to COVID-19 and rotavirus vaccines.
Datasets:GP data, Acute neurological outcomes (Guillain barre syndrome, Bellâs palsy, transverse myelitis, generalized convulsions, acute disseminated encephalomyelitis, encephalitis, and aseptic meningitis) and Intussusception.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-21
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Monica Mtei - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Adoracion Navarro Torne - Collaborator - GSK
Anna Schultze - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Edward Parker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Acute neurological outcomes (Guillain barre syndrome, Bellâs palsy, transverse myelitis, generalized convulsions, acute disseminated encephalomyelitis, encephalitis, and aseptic meningitis) and Intussusception.
Description: Lay Summary
The use of non-randomised study designs to evaluate vaccine safety can be challenging due to 1) differences between vaccinated and unvaccinated people and 2) difficulties in determining when to start follow-up for unvaccinated. Self-controlled-case series (SCCS) avoids the first challenge by comparing adverse events within individuals, with each person acting as their own control. However, this design requires outcome events not to influence vaccination timing. This condition is often violated when an adverse event can either delay or completely prevent future vaccination and is especially problematic when studying vaccines intended to be given in multiple doses. Various approaches to address this exist, but how they compare is unclear. A different approach known as target trial emulation avoids the second challenge through designing a hypothetical trial and then emulating this using existing data to answer a research question. However, itâs been rarely applied in the context of vaccine safety.
We will use two case studies to compare these study design options: a known safety problem of intussusception (a serious bowel disorder) following rotavirus vaccination, and acute neurological outcomes following COVID-19 vaccination. Using SCCS, adverse events will be compared between high-risk times shortly after vaccination and baseline risk times within individuals. In target trial emulations, we will evaluate each vaccine dose's safety by comparing outcomes in vaccinated and unvaccinated individuals matched weekly on factors influencing vaccination and outcomes. This approach will enhance our understanding of these study designs, clarify solutions for multi-dose vaccines, and provide an updated evaluation of COVID-19 vaccine safety.
Technical SummaryWe aim to compare approaches to handle violation of a key SCCS assumption when adverse events influence subsequent vaccination by either delaying or contraindicating it (event-dependent exposures). We will also compare implementation of target trial emulation framework for safety evaluation of a vaccine when it is either rapidly administered (COVID-19 vaccines) or routinely administered (rotavirus vaccine). We will leverage the established safety signal of intussusception following rotavirus vaccination as a case study of methodological interest and evaluate the safety of COVID-19 vaccine on acute neurological outcomes as a different case study while exploring relevant methodological aspects.
We will include first recorded cases of intussusception (infants for rotavirus vaccine evaluation) and acute neurological outcomes (adults of aged above 18 years for COVID-19 vaccine evaluation) in the SCCS analyses. The 1-21 and 1-42 days after vaccination will be used as risk periods for outcomes for rotavirus and COVID-19 vaccine study respectively. Conditional Poisson regression will be used to estimate relative incidence and 95% confidence interval for the safety outcomes for each dose and vaccine. We will compare the use of pre-vaccination window of varying lengths and use of modified SCCS model for event-dependent exposure as approaches to overcome violation of event-dependent exposure assumption in SCCS. We will also explore the use of varying lengths of risk periods and observational periods as sensitivity analyses.
In the target trial emulation, for each dose, exposed and unexposed individuals will be matched on pre-defined baseline confounders for both case studies. Weekly sequential trials will be emulated, and individuals will be followed to the earliest of outcome event, death or deregistration from general practice. Cox proportional hazard models will be used to estimate hazard ratio and 95% confidence intervals for each outcome.
We will utilise the linkages to HES-APC to ascertain hospitalised cases for outcomes.
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Impact of regulatory action on isotretinoin prescribing in primary care: Feasibility study — Craig Allen ...
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Impact of regulatory action on isotretinoin prescribing in primary care: Feasibility study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-29
Organisations:
Craig Allen - Chief Investigator - MHRA
Craig Allen - Corresponding Applicant - MHRAOutcomes:
Rates/proportions of patients with a dermatology referral code; rates/proportions of patients with an isotretinoin prescription; rates/proportions of patients with a record of a dermatology referral code and a prescription for isotretinoin; rates/proportions of patients prescribed isotretinoin and a dermatology referral code stratified by age-groups (
Description: Lay Summary
Isotretinoin is used to treat severe acne. It should only be prescribed by physicians with expertise treating severe acne which has not responded to other treatments, such as antibiotics and creams or gels. Although isotretinoin is mainly prescribed by specialists in hospital settings, some prescribing can occur in primary care by general practitioners with an extended role (GPwER). In 2023, new measures were introduced to strengthen the safe prescribing of oral isotretinoin, which requires two independent prescribers to agree to the initiation of isotretinoin in patients under 18 years of age. The Medicines and Healthcare products Regulatory Agency (MHRA) has received information that the new prescribing measures has led to unintended consequences by placing additional burden on the healthcare system. This includes an increase in dermatology referrals and increased waiting times for patients to start isotretinoin treatment. This feasibility study aims to estimate the available sample size for a potential future study on isotretinoin prescribing in primary care to look at trends in dermatology prescribing rates, referral rates and waiting times between referral and initiation of isotretinoin treatment. This work will support possible further regulatory action to ensure the safe use of isotretinoin and help inform the impact of unintended consequences due to prescribing changes.
Technical SummaryIsotretinoin is an orally administered systemic retinoid used to treat acne where other treatments have proved ineffective. Isotretinoin is predominantly prescribed by specialists in secondary care and to a lesser extent by GPs with an extended role (GPwER). In 2023 new risk minimisation measures were introduced to strengthen the safe prescribing of oral isotretinoin, which requires two independent prescribers to agree to the initiation of isotretinoin in patients under 18 years of age. The Medicines and Healthcare products Regulatory Agency (MHRA) has received information that the new prescribing measures has led to unintended consequences by placing additional burden on the healthcare system. This includes an increase in dermatology referrals and increased waiting times for patients to start isotretinoin treatment. This feasibility study aims to estimate the available sample size for a potential future study on isotretinoin prescribing in primary care to look at trends in dermatology referral rates and waiting times between referral and initiation of isotretinoin treatment. The study will use the Aurum primary care data to ascertain isotretinoin prescriptions from 1st January 2015 onwards.
The objectives are to:
1. Calculate the rates/proportions of patients with a record of a dermatology referral and their age distribution.
2. Calculate rates/proportions of patients with an isotretinoin prescription and their age distribution.
3. Calculate the rates/proportions of patients with a record of a dermatology referral and a prescription for isotretinoin and their age distribution.
3. Tabulations of the time between the date of a dermatology referral record and a first isotretinoin prescription.The feasibility study and any future resulting research will improve our understanding of the effectiveness of current regulatory requirements for isotretinoin prescribing, unintended consequences on the healthcare system and the need for further intervention and monitoring to ensure patient safety.
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Drug utilisation and disease epidemiology for conditions of regulatory interest — Daniel Prieto...
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Drug utilisation and disease epidemiology for conditions of regulatory interest
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-11
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Wanning Wang - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
Incidence and/or prevalence of drug of regulatory interest, incidence and/or prevalence of condition of regulatory interest, summary characteristics (demographics, comorbidities, comedication, incidence of short-term complications and mortality) of people diagnosed with the condition of regulatory interest. Drug utilisation
Condition of regulatory interest:
⢠Paracetamol overdose
⢠Purpura and related conditionsDescription: Lay Summary
The 'Data Analysis and Real-World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from real-world healthcare data sources from across Europe. One area of research relates to estimating how often a specific drug of interest is prescribed and how common a specific condition relating to the drug is among the general population. For regulators such as the EMA, it is important to have access to this kind information as it helps to understand the uptake of specific drugs over time and distribution of potential health outcomes.
The objective of this study is to estimate the new users (âincidenceâ) and existing users (âprevalenceâ) of a medicine. Secondly, to estimate those affected by (âprevalenceâ) or newly diagnosed (âincidenceâ) with a condition during a specific period of time. All these will be calculated in specific populations of interest based on age and sex groups, and over calendar years to look at possible changes over time. In addition, we will look at characteristics of newly diagnosed people such as age and sex, comorbidities, and prescriptions of other medications.
The EMA will request several studies of the same design to assess how often the population takes a certain drug and how common specific conditions are in the population. This will guide regulators in establishing preventative measures to reduce the health condition. The first example will focus on the use of a medicine called âparacetamolâ and examine how often people overdose on the medication.
Technical SummaryPrimary care records provide a unique source of data for estimating the incidence and prevalence of medication use in the community and related health conditions, as most medicines are prescribed by general practitioners. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the uptake of specific drugs of interest and potential health outcomes related to specific drugs of interest for assessing disease burden in the population.
Study design: Cohort study
Population: All people in CPRD GOLD with >=1 year of prior history comprise the source population. Among those, people with the pre-specified condition of regulatory interest will be selected for characterisation. Where the condition is typically requiring hospitalisation, we will use CPRD linked to HES. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Variables: Drug exposure based on prescription data as available within CPRD GOLD. Drugs will be selected by means of the respective RxNorm codes. Conditions will be identified based on SNOMED codes in the mapped data (CPRD and/or HES). Date of death will be retrieved from CPRD.
Drug of interest as expressed by EMA:
⢠Paracetamol
⢠Acitretin
Conditions of regulatory interest:
⢠Paracetamol overdose
⢠Purpura and related conditions
Additional medicines and conditions of regulatory interest will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
Analyses:
(1) Incidence/prevalence of medications of regulatory interest
(2) Incidence/prevalence of conditions of regulatory interest
(3) Summary of characteristics of people with specific conditions of regulatory interest
(4) Utilisation of pre-specified medicines in terms of duration of use, dose or treatment sequence.
All analyses will be stratified by age, sex, and calendar year where relevant.
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Assessing Health and Equity Impacts of COVID-19 Mitigation Strategies on Mothers of Young children, Children, Adolescents and Youths: An Observational Population-based Study in Ontario (Canada) and England — Geoffrey Anderson ...
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Assessing Health and Equity Impacts of COVID-19 Mitigation Strategies on Mothers of Young children, Children, Adolescents and Youths: An Observational Population-based Study in Ontario (Canada) and England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation Domains; CPRD Aurum Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-08
Organisations:
Geoffrey Anderson - Chief Investigator - University of Toronto
Geoffrey Anderson - Corresponding Applicant - University of Toronto
Renzo Calderon Anyosa - Collaborator - University of TorontoOutcomes:
Hospitalization for mental health disorders including: Bipolar Disorder; Anxiety and related disorders; Depressive or other non-psychotic disorders; Personality Disorder; Sexual deviations; Psychosomatic illness; Adjustment reaction; Alcoholism; Drug dependence; Economic problems; Marital difficulties; Parent-child problems; Problems with aged parents or in-laws; Family disruption/divorce; Other problems of social adjustment; Assault related injuries (victims of violence); Deliberate self-harm; Eating disorders.
Description: Lay Summary
On March 11th, 2020, the World Health Organization declared COVID-19 a pandemic. In response, health officials and leaders worldwide introduced measures to slow the spread of the virus. These measures included avoiding contact with other people, wearing masks, and closing and reopening places like daycares, schools, and universities.
These actions, known as non-pharmaceutical interventions (NPIs), disrupted almost every aspect of daily life, especially for mothers with young children, kids, teenagers, and young adults. There's concern that these disruptions may have increased feelings of anxiety and depression, leading more people to seek mental health services. Additionally, there's worry that these impacts might be worse for poorer people than for people who are rich.
Our research aims to use health data from England and Ontario to:
- Understand how the COVID-19 measures affected the use of mental health services by mothers of young children, children, teens, and young adults in these regions.
Technical Summary
- See if changes in mental health service use are linked to poverty and if poor people had more problems during the pandemic that rich people.
- Create a plan to share our findings with the people who can benefit from this information.The study in England will replicate the time-series design and outcomes measures from recently published research on the association between COVID-related NPI and mental health service utilization conducted in Ontario Canada.
Study Populations:
1. Mothers of young children aged 0 to 5 and mothers of children aged 6 to 12.
2. Children: aged 6 â 12, adolescents: aged 13 -18, Young adults: aged 19 -24Outcomes:
Visits to general practitioners by the study populations for specific mental health diagnoses. The analysis in Ontario used diagnostic codes based on ICD codes.Exposure:
The exposure in this study is the imposition and continued application of NPI. Based on the Oxford restriction index for England this was from late March 2020 to March of 2022.Analysis:
Similar to the published studies from Ontario, we will examine the outcomes of interest quarterly for each study population. Data for 20 quarters prior to March 2020 constitutes the pre-exposure period, eight quarters from March 2020 to March 2022 the exposure period, and as many quarters of data as available after March 2022 as the post-exposure period. Negative binomial regression with time and season as predictor variables, will be used to model pre-exposure trends. The residuals are modeled as an autoregressive process to account for serial correlation and seasonality. The pre-exposure fitted model are used to predict the expected rates of use from March 2020 to the last quarter available. The primary outcomes will be the actual observed rates of use after exposure compared to expected rates. The analysis will be stratified by Index of Multiple Deprivation deciles, study group and sex. Additional individual level characteristics such as ethnicity will be included in the model.
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Associations between primary care recorded cannabis use and healthcare utilisation in the UK: a population-based retrospective cohort study of patients with osteoarthritis using UK primary care data — Mikael Sodergren ...
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Associations between primary care recorded cannabis use and healthcare utilisation in the UK: a population-based retrospective cohort study of patients with osteoarthritis using UK primary care data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-25
Organisations:
Mikael Sodergren - Chief Investigator - Imperial College London
Simon Erridge - Corresponding Applicant - Imperial College London
Joht Singh Chandan - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of BirminghamOutcomes:
The primary outcomes of interest are:
- Prevalence of opioid prescribing;
- Incidence of opioid prescribing;
- Annual oral morphine equivalent dose per day of supply;
- Incidence of high and very high opioid dose prescribingKey secondary outcomes include:
- Prevalence of other prescription medications for pain;
- Incidence of other prescription medications for pain;
- Average number of primary care consultations per year;
- Average number of primary care consultations related to osteoarthritis per yearDescription: Lay Summary
Cannabinoids, the main chemicals found within the cannabis plant, have been shown to affect pain transmission signals from the site of pain, up the spinal cord and to the brain. In addition to this they have also been demonstrated to affect the emotional processing of pain itself.
However, there is a lack of high-quality evidence on the effects of pharmaceutical grade cannabis on chronic pain in humans. As such, there are no licensed medical cannabis preparations for chronic pain. Therefore, whilst chronic pain is the most common reason why medical cannabis is prescribed in the UK, it is only available privately.
Estimates suggest that 1.4 million people in the UK purchase illicit cannabis for health reasons, with chronic pain and arthritis being the third and fourth most common reasons why.
Studies from North America suggest that in some jurisdictions where cannabis has become available, this has been associated with a reduction in prescriptions of opioids.
No studies have sought to examine if there is any relationship between cannabis use and healthcare utilisation in UK patients with chronic pain secondary to osteoarthritis.
This study will use GP data from individuals with osteoarthritis who are known cannabis consumers and compare their outcomes to patients who do not have any recorded cannabis use. The main aims are to compare the quantity of opioid pain medications and other pain medications between each group. This will help inform our knowledge of the impact of cannabis consumption on managing the pain associated with osteoarthritis.
Technical SummaryIn pre-clinical studies, cannabinoids derived from cannabis have been shown to reduce the transmission of nociceptive signals, whilst also impacting central sensitisation, increasing inhibition of ascending signals and modifying the emotional and cognitive manifestations of pain in the brain. They have also demonstrated anti-inflammatory effects.
The current clinical evidence on the effects of cannabis on chronic pain, however, is typically of low-quality and is highly heterogenous. There has only been one Phase 2A randomised controlled trial on a medical cannabis preparation for osteoarthritis to date, specifically. Consequently, there are no licensed preparations of medical cannabis for osteoarthritis-associated chronic pain, meaning people who want to use cannabis for this reason must access unlicensed medical cannabis preparations, or rely upon self-medicating via illicit channels.
The aim of this study is to compare differences in outcomes between individuals with osteoarthritis with a known exposure to cannabis, with those with no recorded exposure to cannabis using primary care data. Exposed patients will be identified by pre-defined clinical codes, and subsequently matched with unexposed control patients.
The outcomes of interest will include a comparison of the incidence of opioid prescribing, incidence of strong opioid prescribing, annual oral morphine equivalent dose per day of supply, incidence of other prescription medications for pain, and primary care healthcare utilisation. Comparisons between each group will be conducted utilising an independent t-test or Mann-Whitney U test as appropriate.
The outcomes of this study will for the first time provide information on the pain-specific impact of exposure to cannabis on individuals with osteoarthritis in the UK. This will help inform future research to address the unmet need of limited available treatments for osteoarthritis-associated chronic pain. It can also be utilised to inform harm reduction strategies for people consuming cannabis illicitly for health reasons.
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Exploring disease signatures and compounded risk assessment scores from longitudinal common blood markers in the Clinical Practice Research Datalink — Craig Currie ...
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Exploring disease signatures and compounded risk assessment scores from longitudinal common blood markers in the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-15
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Abicumaran Uthamacumaran - Collaborator - Oxford Immune Algorithmics
Hector Zenil - Collaborator - Oxford Immune Algorithmics
Kourosh Saeb-Parsy - Collaborator - Oxford Immune Algorithmics
Luan Ozelim - Collaborator - Oxford Immune Algorithmics
Riya Nagar - Collaborator - Oxford Immune AlgorithmicsOutcomes:
The study will seek to determine associations between blood counts and the following conditions.
Primary outcomes: Non-Hodgkinâs lymphoma, Hodgkin lymphoma, Multiple myeloma, Acute lymphoblastic leukaemia (ALL), acute myeloid leukaemia (AML), chronic lymphocytic leukaemia (CLL), chronic myeloid leukaemia (CML), Haemolytic anaemias, Thalassemia, Sickle cell disorders, Aplastic anaemias, Coagulation defects, Factor VIII deficiency, Factor IX deficiency, Von Willebrandâs disease, Haemorrhagic conditions, Allergic purpura/platelet disorders , Influenza, Common cold, Bronchiolitis, Herpes zoster, Enteroviruses, Ebola, Poliomyelitis, Measles, Smallpox, Varicella, Norovirus, Mumps, Rubella, Infectious mononucleosis, Hepatitis A/B/C, Rabies, Human papilloma virus, HIV/AIDS, SARS/COVID, Campylobacter, Chlamydia, Cholera, Clostridium Difficile, Diphtheria, E. Coli, Gonorrhoea, Legionella, Listeria, Lyme disease, Salmonella, Shigella, Staphylococcus, Streptococcus, Typhoid, Tuberculosis, Syphilis, Tetanus, Malaria, Cryptosporidium, Giardiasis, Helminths, Toxoplasmosis, Trichomoniasis, Leishmaniasis, Chagaâs disease, Trypanosomiasis, SchistosomiasisSecondary outcomes: Achalasia, Addisonâs disease, Anaphylaxis, Amyloidosis, Ankylosing spondylitis, Antiphospholipid syndrome, Autoimmune hepatitis, Coeliac disease, Chagaâs disease, Crohnâs disease, Dermatomyositis, Giant cell arteritis, Glomerulonephritis, Graveâs thyroiditis, Guillain-Barre Syndrome, Henoch-Schonlein Purpura, IgA nephropathy, Idiopathic (immune) thrombocytopenic purpura, Type 1 diabetes, Lichen planus, Lichen sclerosis, Lupus, Meniereâs disease, Multiple sclerosis, Myasthenia gravis, Myositis, Paroxysmal nocturnal haemoglobinuria, Polyarteritis nodosa, Polymyalgia rheumatica, Primary biliary cholangitis, Primary sclerosing cholangitis, Psoriasis, Psoriatic arthritis, Reactive arthritis, Reynaudâs disease, Rheumatic arthritis, Rheumatic fever, Sarcoidosis, Scleroderma, Systemic Lupus erythematosus, Thrombocytopenic purpura, Thyroid eye disease, Ulcerative colitis, Vasculitis, Vitiligo, Cancers (Tongue, Mouth , Pharynx, Oesophagus, Stomach, Small intestine, Colon, Rectum, Anal canal, Liver, Gallbladder and biliary tree, Pancreas, Larynx, Lungs and bronchus, Bone, Skin, Cervix, Ovary, Prostate, Testis, Bladder, Kidney, Ureter, Brain, Thyroid, Parathyroid) Obesity, Coronary artery disease, Angina, Peripheral vascular disease, Hypertension, Congestive cardiac failure, Arrhythmias, Congenital heart defects, Polycystic kidney disease, Kidney stones, Acute kidney injury, Cerebral aneurysm, Varicose veins, Aortic aneurysms, Autism, Alzheimerâs disease, Ataxia, Dementia, Parkinsonâs disease, Huntingdonâs chorea, Epilepsy, Stroke, Spina bifida, Muscular dystrophy, Neuropathy, Migraine, Motor neurone disease, Cerebral palsy, Amnesia, Vertigo, COPD, Asthma, Bronchitis, Pulmonary fibrosis, Emphysema, Alpha-1 antitrypsin deficiency, Cystic fibrosis, Sarcoidosis, Pneumothorax, Osteoporosis, Osteoarthritis, Scoliosis, Gout, Bursitis, Acne, Ankylosing spondylitis, Tendonitis, Fibromyalgia, Carpal tunnel syndrome, Bone fractures, Urticaria, Dermatitis, Gallstones, Gastroesophageal reflux disease, Irritable bowel syndrome, Constipation, Pancreatitis, Peptic ulcer disease, Chronic diarrhoea, Faecal incontinence, Diverticulitis, Lactose intolerance, Urinary incontinence, Benign prostatic hyperplasia, Type 2 diabetes, Hypercholesterolemia, Gaucher disease, Hunter syndrome, Porphyria, Wilsonâs disease, Phenylketonuria, Tay-Sachs disease, Hemochromatosis, Anorexia nervosa, Bulimia nervosa, Depression, Schizophrenia, Anxiety disorder, Obsessive compulsive disorder, ADHD, Bipolar disorder, PTSD, Insomnia, Narcolepsy, Sleep apnoea, Addiction, Personality disorders, Endometriosis, Uterine prolapse, Menorrhagia, Dysmenorrhea, Fibroids, Subfertility, Glaucoma, Abnormal visual acuity, Cataracts, Optic atrophy, Optic neuritis, Hearing loss and Anosmia.
ICD10 and medcode lists will be created as part of the study process.Description: Lay Summary
Blood tests are widely known to be clinically and biologically informative, to help diagnose numerous diseases such as anaemia, infection, cancer and autoimmune diseases. Gaining an understanding of an individualâs immune system over time using a blood test result has the potential to transform personalised healthcare. If we can better understand a patientâs blood results this could potentially transform our ability to make earlier diagnoses and develop more ways to effectively prevent diseases. Currently the widely accepted ânormalâ range for a blood test result is the same range for all patients of the same gender. However immune systems vary between patients and what is classed as within the ânormalâ range for one patient may be an âabnormalâ result based on their previous blood results. This widely accepted assessment of a result as ânormalâ or âabnormalâ seems to contradict the use of a blood test as a personalised measure of the individualâs immune system due to the broad ânormalâ range.
Technical Summary
We aim to select patients who have had a blood test in CPRD and use the values to calculate an âimmune age scoreâ across different diseases of interest. We will also validate the immune age scores previously published in CPRD patients. These validated risk scores can then be used in precise healthcare and predictive medicine to learn a patientâs optimal blood health over time.The Full blood count (FBC) is the most commonly performed medical diagnostic test worldwide. It is estimated there are more than 4 billion FBC tests per year globally. Common haematological markers such as those from the FBC are clinically and biologically informative and are made up of component tests which indicate numerous medical issues. Using a learning adaptive algorithm, we will create risk scores comparing a patients chronological age from birth to an estimation of a biological immune age to calculate a patientâs optimal blood health over time. The risk scores will consist of numerical and colour-coded versions and will be calculated from the components of the FBC, and other relevant blood markers available, and the score effectivity tested and validated against the patient clinical data (e.g. diagnosis, medication), including lifestyle (e.g. drinking or smoking). The resulting risk score values will be grouped as belonging to healthy individuals or to a selected list of common diseases. In addition, we will validate previous findings related to compounding markers into risk assessment scores. Patient data will be selected for the project only if they have a record of a blood test recorded. The start of Clinical Practice Research Datalink (CPRD) follow-up will be defined as the later of the patientâs registration date and, in CPRD GOLD, their practiceâs up-to-standard date; the end of CPRD data follow-up will be defined as the earliest of the patientâs transfer-out date, date of death (if applicable), and the last data-collection date for their practice. The presentation date will be defined as that of the patientâs first ever record with a code indicative of a blood test. The objective is to better understand the role of the immune system by monitoring common measured blood marker variations over time using personally-adaptive risk scores and assessing longitudinal disease signatures.
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Premature all-cause and cause-specific mortality trends, comorbidities, and medication use among those with gout — Hyon Choi ...
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Premature all-cause and cause-specific mortality trends, comorbidities, and medication use among those with gout
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-11
Organisations:
Hyon Choi - Chief Investigator - Arthritis Research Canada
Hyon Choi - Corresponding Applicant - Arthritis Research Canada
Mary De Vera - Collaborator - University Of British Columbia
Na Lu - Collaborator - Arthritis Research CanadaOutcomes:
Premature mortality trends among those with gout (primary exposure of interest), type 2 diabetes (T2D; metabolic disease comparator and positive control exposure), and osteoarthritis (OA; arthritis comparator and negative control exposure)
Excess comorbidity trends among those with gout (primary exposure of interest), T2D (metabolic condition comparator and positive control exposure), and OA (arthritis comparator and negative control exposure)
Medication use trends among those with gout
Proportion of premature mortality risk among those with gout that is mediated by NSAID and opioid useDescription: Lay Summary
Gout is the most common inflammatory arthritis worldwide. In addition to pain and disability, gout patients are at an increased risk of developing various complications (including cardiovascular disease, diabetes, and kidney disease) and premature death. Research has shown that gout care continues to be suboptimal, and that patientsâ increased risk of premature death has not improved in past decades. Moreover, there has been a recent rise in opioid use among gout patients. Despite these worrisome trends, more recent data on the risk of death among gout patients are not available, including cause-specific data. This study aims to provide updated estimates on the risk of premature death among gout patients, including quantification of this risk due to different causes as well as among pertinent subgroups defined by age, sex, and race/ethnicity. Moreover, this study aims to quantify the mediating role that certain medications (e.g., opioids) may play in the risk of premature death among gout patients. Achieving this will benefit people living with gout, as it can help us learn about any ongoing premature risk of death, understand subgroups who are at particular risk, and shed light on medications which may be exacerbating this risk, thereby allowing for preventive measures and better patient care.
Technical SummaryGout is the most common inflammatory arthritis, and its incidence, prevalence, and disability burden have risen worldwide for decades. This growing disease burden is further complicated by a high level of cardiovascular-kidney-metabolic comorbidities, including hypertension, type 2 diabetes, chronic kidney disease, and heart failure. More recently, certain neuropsychiatric complications of gout (i.e., depression and anxiety) have also been recognized. This modern gout epidemic combined with suboptimal gout care have contributed to the recent rise in opioid use in gout patients. In addition to this increased comorbidity burden, people with gout experience a higher risk of premature all-cause mortality, and this excess risk was shown to be unchanged from 1999-2014. However, updated large-scale analyses of this premature mortality risk are urgently needed, including studies of cause-specific mortality. Moreover, population-level studies examining trends in comorbidity onset as well as key medication use would be valuable for improving care for gout patients, especially for those early in the disease course. Through this project, we will assess temporal trends in premature all-cause and cause-specific mortality among adults with gout from 1997-2023; moreover, we will assess temporal trends in the risk of selected cardiovascular-kidney-metabolic and neuropsychiatric comorbidities. We will compare these estimates with those from two related conditions, type 2 diabetes (a metabolic disease with several therapeutic and management advances [positive control exposure]) and osteoarthritis (another form of arthritis without comparable advances [negative control exposure]). Finally, we will quantify the mediating role of key medications (e.g., opioids) in the association between gout and premature mortality. This research will benefit people living with gout, as it can help elucidate any sustained premature mortality gap, understand subgroups who are at particular risk, and understand the role that key medications may play in exacerbating this risk, thereby allowing for preventive measures and better patient care.
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Improving early detection of lung cancer in never-smokers by developing risk prediction models using retrospective primary care medical records — Neal Navani ...
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Improving early detection of lung cancer in never-smokers by developing risk prediction models using retrospective primary care medical records
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-06
Organisations:
Neal Navani - Chief Investigator - University College London ( UCL )
Sindhu Naidu - Corresponding Applicant - University College London ( UCL )
Honghan Wu - Collaborator - University College London ( UCL )
James Bailey - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Rumana Omar - Collaborator - University College London ( UCL )
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
Diagnosis of LCINS identified from cancer registry
Stage (I-IV) at diagnosis identified from cancer registry
Mortality from LCINS (in days, one-year and five-year) identified from cancer registry and ONS
Symptoms associated with LCINS identified from coded GP data from CPRDDescription: Lay Summary
Lung cancer causes the most cancer-related deaths globally and in the United Kingdom (UK). In 2020, 51,983 adults in the UK were diagnosed with this disease and 36,518 died from it. Many people think lung cancer is due to smoking. However, at least one in ten people with lung cancer are ânever-smokersâ who have smoked less than 100 tobacco cigarettes in their life. In fact, lung cancer in never-smokers (LCINS) is the seventh most common cause of cancer-related death.
In the UK, people who have a history of smoking are invited for screening. However, we do not have any methods to detect LCINS early in never-smokers. We also do not understand LCINS very well. If we change this, we can save lives and improve the lives of people living with lung cancer.
Our aim is to improve our ability to detect LCINS earlier.
We will not collect any new information from patients or make changes to their care. Instead, we will use general practice health records which has been anonymised to remove any personal data. We will:
- Create a way to predict someoneâs risk of LCINS in the next five years
- Create a tool to help doctors diagnose LCINS based on things like symptoms and blood tests.
- See if factors like gender and ethnicity are related to LCINS.Patients with LCINS have been involved in the design of this study and will continue to inform the study including helping to share the findings.
Technical SummaryAim: To improve the early detection of lung cancer in never-smokers (LCINS)
Study population and data sources: Never-smokers from CPRD from 2008 to 2023, linked to National Cancer Registration and Analysis Service (NCRAS), Office of National Statistics (ONS) and Hospital Episode Statistics (HES)Objective 1
Outcome: To create two risk prediction models for outcomes of LCINS incidence and mortalityStudy design: We have conducted a systematic review to identify model variables. We will use logistic regression and Cox models and explore the use of competing risks and machine learning techniques such as random forest to see if they can improve predictive accuracy. We will use multiple imputation based on chained equations to impute missing values for predictors. Model performance including calibration and discrimination will be assessed.
Benefit: To select high-risk never-smokers who may benefit from early detection (e.g. screening) and therefore reduce mortality from LCINS
Objective 2
Outcome: To create a diagnostic model to predict the risk that a symptomatic patient has LCINS at time of presentationStudy design: We will use deep-learning-based natural language processing on coded GP records to identify variables (such as symptoms) associated with LCINS. Never-smokers with one of the three most common symptoms will be selected. Using methods similar to (1), we will use data including symptoms, prescriptions and laboratory test results to create and assess our model.
Benefit: To improve diagnosis and referral for LCINS
Objective 3
Outcome: To validate data on LCINSStudy design: We will compare data from CPRD to other data sources (UK Biobank, NCRAS). Descriptive statistics will be used to describe sociodemographic and clinical characteristics in LCINS. Multiple regression analysis will be performed to review stage and survival accounting for covariates including sociodemographic characteristics.
Benefit: To provide much-needed understanding on LCINS in the UK and elucidate possible socioeconomic inequalities
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Comparison of United Kingdom Biobank Population to a CPRD Aurum random sample population: a descriptive cohort study — George Kafatos ...
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Comparison of United Kingdom Biobank Population to a CPRD Aurum random sample population: a descriptive cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-11
Organisations:
George Kafatos - Chief Investigator - Amgen Ltd
Rebecca Persson - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
David Neasham - Collaborator - Amgen Ltd
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Primary Outcomes: myocardial infarction; heart failure; transient ischemic attack; peripheral artery disease; unstable angina; non-alcoholic steatohepatitis; atherosclerotic cardiovascular disease; thyroid eye disease; lipid lowering therapies; statins; coronary artery bypass grafting; percutaneous coronary intervention; peripheral artery disease revascularization; lipids; glucose; HbA1c; influenza vaccination; pneumococcal vaccination; shingles vaccination; tetanus vaccination; body mass index; waist circumference; ejection fraction measurements; death.
Description: Lay Summary
The United Kingdom (UK) Biobank (UKB) database contains health information that is not available in other medical data sources. To properly use this valuable information, it is important to understand how the UKB population compares with patients in other data sources. UKB patients volunteer to participate and there is concern that these volunteers may be healthier than the general UK population. Clinical Practice Research Datalink (CPRD) Aurum is a large electronic health record database that is representative of all of England. The aim of this study is to compare UKB and CPRD Aurum demographics (such as age, sex, race/ethnicity) and distributions of specified events, such as heart disease, heart attack, medicines prescribed, and death. This study will provide information to help researchers and doctors understand whether the two patient populations have important differences that could impact how to interpret UKB study results on important public health issues.
Technical SummaryThe United Kingdom Biobank (UKB) is a large population-based prospective cohort study collected for half a million UK adult volunteer participants (aged 40-69 at enrollment in 2006-2010). UKB contains clinical details beyond what is available from other population-based medical data sources. However, a potential limitation of the UKB is that its population may be healthier than the general UK population due to volunteer bias.
The objective of this descriptive cohort study is to describe representativeness of the UKB population in comparison to CPRD Aurum. We will 1) select a random sample of CPRD Aurum patients aged 40-69 in 2006-2010, 2) describe demographic characteristics of the UKB population compared to CPRD Aurum random sample cohort, and 3) estimate prevalence and incidence rates of each outcome of interest in UKB and CPRD Aurum random sample cohort. Linked Hospital Episode Statistics Admitted Patient Care and Office of National Statistics Mortality data will be used as common data sources for direct comparison. Study results will inform UKB representativeness and appropriate interpretation of results in comparison to CPRD Aurum.
We will provide descriptive statistics of demographics (mean, median, interquartile range) for each cohort (UKB and CPRD Aurum random sample cohort). For each cohort and for each clinical endpoint of interest, we will estimate prevalence at cohort entry with 95% confidence intervals (CI). And, during follow-up, we will calculate incidence rates (95% CI) and Kaplan Meier cumulative incidence plots (95% CI) for each outcome. Prevalences and incidences will be compared qualitatively between the random CPRD Aurum cohort and the UKB cohort to be supplied by the Amgen team. Study results will describe the representativeness of the UKB through comparison to the well-known population-based data source, CPRD Aurum. The results of this study will inform future UKB study design and interpretation of results important to public health.
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Recurrent Events and Characteristics following a first-ever Transient Ischemic Attack: a multi-database retrospective cohort study — Daloha Rodriguez Molina ...
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Recurrent Events and Characteristics following a first-ever Transient Ischemic Attack: a multi-database retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Daloha Rodriguez Molina - Chief Investigator - Bayer AG
Daloha Rodriguez Molina - Corresponding Applicant - Bayer AG
GEORGIOS ARGYRIOU - Collaborator - Bayer AG
Gowtham Rao - Collaborator - Bayer AG
Katrin Manlik - Collaborator - Bayer AGOutcomes:
Ischemic stroke;Intracranial bleeding;Hospitalization-related bleeding;New-onset atrial fibrillation;Recurrent TIA
Description: Lay Summary
A transient ischemic attack, or TIA, is a temporary blockage of blood flow to the brain, usually due to a clot in a blood vessel. The clot usually dissolves on its own or gets dislodged, and the symptoms normally last a few minutes or hours. While a TIA usually does not cause permanent damage, it is a warning signalling of a possible full-blown stroke ahead. To date, most epidemiological research in this area has focused on understanding populations suffering from a stroke, but little is known about characteristics and treatment of patients suffering a TIA, and their probability of having a full-blown stroke.
Technical Summary
Our study aims to understand the characteristics of patients at the time of having a TIA for the first time in their life (baseline characteristics) and the likelihood of occurrence of a stroke later in time. To do so, we will analyse anonymised data from the USA, Japan, and the United Kingdom using administrative claims and electronic health records databases.
No formal statistical comparisons will be performed, and hence only descriptive statistics will be calculated (mean and standard deviations for continuous variables and percentages for categorical variables). Our results will help to improve management of patients with a TIA in the UK by contributing to identifying those at highest risk of a subsequent stroke. In addition, from a public health perspective, understanding treatment patterns will generate insights on the most efficient therapeutic strategies in patients suffering a TIA.A transient ischemic attack (TIA) is a medical condition characterized by focal arterial ischemia with transient symptoms (lasting
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The long-term impact of the COVID-19 pandemic on childhood otitis media incidence: a population-based cohort study — Arief Lalmohamed ...
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The long-term impact of the COVID-19 pandemic on childhood otitis media incidence: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-11-04
Organisations:
Arief Lalmohamed - Chief Investigator - Utrecht University
Arief Lalmohamed - Corresponding Applicant - Utrecht University
Alastair Hay - Collaborator - University of Bristol
Anne Schilder - Collaborator - University College London ( UCL )
Joline de Sévaux - Collaborator - University Medical Centre Utrecht
Martin Gulliford - Collaborator - King's College London (KCL)
Patrick Souverein - Collaborator - Utrecht University
Roderick P. Venekamp - Collaborator - University Medical Centre Utrecht
Roger AMJ Damoiseaux - Collaborator - University Medical Centre UtrechtOutcomes:
Incidence of incident otitis media (OM) and OM related antibiotic / analgesic prescriptions
Description: Lay Summary
An ear infection is an important reason for children to visit general practitioners and to receive antibiotics. Over the last decade, several factors might have influenced health care regarding the management of ear infections among children. For example, the COVID-19 pandemic led to the implementation of infection prevention measures, affecting children due to social distancing and the closing of schools and day-care. In our earlier Dutch study, indeed, the incidence of ear infections decreased substantially during the first year of COVID-19. Moreover, the pandemic resulted in more remote consultations, which may have impacted the decision to prescribe antibiotics. It is however unclear to which extent this has occurred and if any trends have normalized towards pre-pandemic numbers. From a public health point of view, this may yield vital information: it helps in understanding the magnitude of antibiotic use among children which is important in relation to antimicrobial resistance. In addition, it adds to the knowledge on effective use of remote physician consultations, which is a topic of increasing interest given the rise in incidence.
Hence, objectives of this study are therefore to evaluate changes in (1) incidence rates of ear infections and (2) the use of ear infection related antibiotics and pain killers over time in children between 2009 and 2024, in particular before, around and after the COVID-19 pandemic.
Technical SummaryOtitis media (OM) is a prime reason for children to visit general practitioners and for the prescription of antibiotics. Over the last decade, several factors might have influenced health care regarding OM management. The COVID-19 pandemic led to the implementation of infection prevention measures, affecting children due to social distancing and the closing of schools and day-care. A previous study from our group demonstrated that the incidence of OM in the Netherlands during the first year of the COVID-19 pandemic decreased substantially by 63% compared to the previous year. This decrease might be attributed to the infection prevention measures in place, yet the limited follow-up period poses challenges in interpreting these findings.
Additionally, general practices were compelled to reorganize care for respiratory infections due to the COVID-19 pandemic, resulting in more remote consultations. It is crucial to understand the extent to which these changes have impacted the decision to prescribe antibiotics (and the type of consultations for children with OM). Analyzing CPRD data concerning this topic can provide further insights into the current and future management of care for children with OM.Hence, objectives of this study are therefore to assess changes in (1) incidence rates of otitis media (OM) and (2) OM related antibiotic and analgesic prescribing behaviour over time in children between 2009 and 2024. More specifically, we will utilize an interrupted time series design to evaluate the influence of calendar time, and â more specifically â the COVID-19 pandemic lockdown and lift, stratified by age (< 2 years, 2-5.9 years, 6-11.9 years and 12-18 years), sex and OM type.
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ID-433: Long term surveillance of patients on the Lipid Management Pathway — Imperial College Healthcare NHS Trust...
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ID-433: Long term surveillance of patients on the Lipid Management Pathway
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Lipid management. Commercial
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ID-432: Geographic Atrophy (GA) Health Outcomes Study — LNWH/Imperial College Health Partners...
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ID-432: Geographic Atrophy (GA) Health Outcomes Study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-24
Opt Outs: no information provided./p>
Organisations: LNWH/Imperial College Health Partners
Description: Geographic atrophy. Commercial
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ID-434: High Intensity Users Scoring Algorithm — Imperial College Healthcare NHS Trust...
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ID-434: High Intensity Users Scoring Algorithm
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: HIU.
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ID-435: Fine-tuning and Validating a Type 1 Diabetes Risk Prediction Algorithm — Stanhope Mews Surgery...
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ID-435: Fine-tuning and Validating a Type 1 Diabetes Risk Prediction Algorithm
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-24
Opt Outs: no information provided./p>
Organisations: Stanhope Mews Surgery
Description: Type 1 Diabetes. Commercial
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ID-436: A study to assess the affects of a randomised community health-worker led intervention on uptake of preventative care services in London, UK — Imperial College Healthcare NHS Trust...
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ID-436: A study to assess the affects of a randomised community health-worker led intervention on uptake of preventative care services in London, UK
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Preventative care services.
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ID-437: Clinical impact and healthcare utilisation of a digital diabetes self-management platform (Know Diabetes): a mixed-methods study — Chelsea and Westminster NHS Foundation Trust...
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ID-437: Clinical impact and healthcare utilisation of a digital diabetes self-management platform (Know Diabetes): a mixed-methods study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-24
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster NHS Foundation Trust
Description: Cancer patients.
Source
2024 - 10
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— unknown...
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Where: unstated
When: 2024-10-31
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding a 16-month Research Fellowship to conduct research using the Nursing and Midwifery Council (NMC) Register linked to Census 2021 dataset. The project is a result of an ADR UK fellowship opportunity which invited applications to carry out research using eligible ADR England flagship datasets.
This unique dataset links the NMCâs UK-wide register of nurses, nursing associates, and midwives with the Census 2021 for England and Wales. It provides rich, de-identified information on these professions, enabling research on entry, retention, and movement across regions. The dataset is being accessed within the Integrated Data Service, a trusted research environment delivered by the Office for National Statistics.
Through this fellowship, Professor Iain Atherton is leading a project that aims to understand migration trends among UK healthcare professionals, informing future workforce planning and educational investment. His research analyses geographical movement, with a focus on first-year registrants, using both cross-sectional and longitudinal data to explore the factors that influence migration.
These findings around migration patterns will help policymakers and healthcare organisations develop strategies for recruiting and retaining healthcare professionals in different parts of the UK, ultimately improving services for patients.          Â
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Evaluation of machine learning based prediction models for lung cancer detection using linked primary care and cancer registry data — Garth Funston ...
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Evaluation of machine learning based prediction models for lung cancer detection using linked primary care and cancer registry data
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-30
Organisations:
Garth Funston - Chief Investigator - Queen Mary University of London
Garth Funston - Corresponding Applicant - Queen Mary University of London
Brendan Delaney - Collaborator - Imperial College London
Oleg Blyuss - Collaborator - Barts and the London Queen Mary's School of Medicine and DentistryOutcomes:
The primary clinical outcome is a diagnosis of a lung cancer ( ICD10: C34), as recorded in NCRAS data. Model performance for early-stage cancer (stage I-II) will be explored in sensitivity analyses.
Description: Lay Summary
Lung cancer is the most common cause of cancer related death in the United Kingdom. The disease is usually not picked up until it is advanced when it is harder to treat and cure. Earlier detection could improve patient outcomes including survival.
Most people with lung cancer are diagnosed after they develop symptoms and visit their General Practice (GP), but symptoms are generally non-specific, such as cough, so cancer is often not initially suspected. However, clinical activity (e.g. blood tests performed and medications prescribed) can change months or years before lung cancer diagnosis, and distinct patterns of clinical events (âpatient pathwaysâ) can be identified using Artificial Intelligence (AI) approaches. Recently, an AI model was developed using longitudinal GP healthcare record data to help determine whether patients in primary care could have lung cancer. The model performed well, picking-up 86% of lung cancers using anonymised primary care data, but it is important to examine performance in other groups before it can be used clinically. There is also potential for model improvement through inclusion of additional information types e.g. hospital data.
In this study, we will use primary care and linked hospital and cancer registry data to examine how accurate the lung cancer model is and compare its performance against existing models. We will also explore whether updating the model (with additional data types and altered time windows) improves performance. This research has the potential for public benefit as the model could aid early detection of lung cancer.
Technical SummaryLung cancer is the most common cause of cancer related mortality in the UK. 65% of patients are not diagnosed until the disease is advanced, which contributes to poor outcomes including survival. However, as clinical activity (e.g. consultations, blood tests and prescription patterns) can change months or years prior to lung cancer diagnosis, there are opportunities for earlier detection. Advances in machine learning methods mean that temporal patterns in clinical events, recorded within longitudinal electronic healthcare records, can be used to predict lung cancer diagnosis.
Recently, a transformer based deep learning model was developed, using electronic healthcare data from North West London, to detect patients at high risk of lung cancer diagnosis. Natural Language Programming (NLP) approaches were applied to model longitudinal patterns of, and relationships between, variables within the data. The model performed well on split sample validation (Area Under the Curve: 0.92%).
In this study, we aim to externally validate this deep learning model using structured primary care (CPRD GOLD and Aurum) and linked hospital (HES APC) and cancer registry (NCRAS) data. We will calculate measures of model discrimination and calibration for lung cancer diagnosis within defined periods (6, 12, 18, 24, 36 months). Accuracy (sensitivity, specificity, positive and negative predictive values) will also be calculated at different risk thresholds (including a â¥3% lung cancer risk). Performance will be compared against the best performing pre-existing models (identified through literature review), where feasible. We will also examine whether updating the model by pre-training on other predictors such as in blood test results, adjusting time windows, and incorporating time periods between events, improves model performance. If the model performs well, it could be used within general practice to select appropriate patients for further investigation, benefiting patients and the public through earlier detection of lung cancer.
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Assessing SYmptom-driven versus Maintenance Preventer Therapy for the Outpatient Management of AsThma In Children : A non-inferiority, pragmatic, randomised controlled trial using routinely collected outcome data — Ian Sinha ...
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Assessing SYmptom-driven versus Maintenance Preventer Therapy for the Outpatient Management of AsThma In Children : A non-inferiority, pragmatic, randomised controlled trial using routinely collected outcome data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Carstairs Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-14
Organisations:
Ian Sinha - Chief Investigator - University of Liverpool
Susanna Dodd - Corresponding Applicant - University of Liverpool
Christiane Marin - Collaborator - CPRD
Clare Iles - Collaborator - CPRD
Dyfrig Hughes - Collaborator - Bangor University
Giovanna Culeddu - Collaborator - Bangor University
Paula Williamson - Collaborator - University of Liverpool
Rebecca Ghosh - Collaborator - CPRD
Susan Beatty - Collaborator - CPRDOutcomes:
⢠Risk of asthma attack requiring oral corticosteroid (OCS) in the study population
⢠The cost-effectiveness (incremental cost per quality-adjusted life year, QALY gained) of symptom-driven use of ICS - numbers of prescriptions and interactions with healthcare providers
⢠Time to first asthma attack requiring treatment with OCS
⢠Asthma control
⢠Unscheduled healthcare utilisation
⢠All cause hospitalisation
⢠Health Related Quality of Life
⢠Treatment failure
⢠Cumulative dose of ICS over the 12 month treatment period
⢠All cause mortalityDescription: Lay Summary
Asthma is the most common long-term disease in children in the UK. It causes cough and difficulty
Technical Summary
breathing. These symptoms get worse during asthma attacks. The main treatment is a preventer inhaler, containing steroids.
We are going to do a trial to help us learn how best to treat children with mild asthma. We want to find out if taking a preventer inhaler only on days when a child has symptoms is as effective as taking it every day. Less preventer inhaler may make their asthma symptoms worse, but using them too much can cause unwanted side-effects. The study will involve around 2000 children from GP practices across the UK. Parents of children aged 6-15 with mild asthma at these practices will be asked if they would like to take part. If the parents agree, their child will be randomised (assigned by chance) either to take their preventer inhaler every day, or only when they have symptoms of asthma. We want to know if this increases the chances of having an asthma attack that needs treatment. We also want to see whether there is a difference between the two approaches in terms of asthma symptoms, hospital admissions, the childâs overall quality of life, and overall costs (for example, costs for prescriptions, GP appointments and hospital visits).
This study will answer important questions on how best to treat children with mild asthma. This will benefit the wider public by helping to guide clinical practice on treatment of mild asthma in children.Aims: To evaluate whether in children (6 to 16 years old) with mild asthma, symptom-driven use of inhaled corticosteroid (ICS) is non-inferior to maintenance ICS with regards to the risk of asthma attacks requiring oral corticosteroids (OCS).
Design: Pragmatic open-label Randomised Controlled Trial (RCT), in general practices across the UK who provide data to CPRD.
Outcomes: Collected from the electronic health record (EHR): Hospital Episode Statistics (HES) admission data (to determine hospitalisations); HES A&E data (SAEs, asthma exacerbations and treatment failure involving ICS), ONS (mortality). Patient-reported outcomes: collected on IRSP and REDCap (an electronic data capture platform). All data will be processed and provided by CPRD and will be re-pseudonymised using a study specific primary key.Interventions: Children, already prescribed ICS, will be randomised 1:1 to either continue as prescribed with maintenance ICS use every day (control arm) or reduce to symptom-driven ICS use (intervention arm) which entails using the ICS only on days when Short-acting beta-2 agonists (SABAs) are required. The treatment period is 12 months.
Analysis: 1854 children (927 per group) will provide 80% power with a one-sided 2.5% significance level to reject the null hypothesis that the symptom-driven regime is inferior to the maintenance regime. The primary outcome, and other binary outcomes, will be analysed using logistic regression. Quality of life scores will be analysed using analysis of covariance adjusted for baseline score Health economic analyses will estimate the cost-effectiveness (incremental cost per quality-adjusted life year, QALY gained) of symptom-driven use of ICS.
Public Health Benefit: This study will answer important questions on how best to treat children with mild asthma which may benefit patients through reduced exposure to inhaled steroids as well as determining the most cost-effective treatments. This will support the reconsideration of national and international guidance on treatment for children with asthma.
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Health care service utilisation following a diagnosis of dementia or another neurodegenerative condition: assessing the impact of inequalities — Laura Gamble ...
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Health care service utilisation following a diagnosis of dementia or another neurodegenerative condition: assessing the impact of inequalities
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-18
Organisations:
Laura Gamble - Chief Investigator - Newcastle University
Laura Gamble - Corresponding Applicant - Newcastle University
Adelina Comas-Herrera - Collaborator - London School Of Economics & Political Science
Anthony Martyr - Collaborator - University of Exeter
Catherine Charlwood - Collaborator - University of Exeter
Catherine Quinn - Collaborator - University Of Bradford
Fiona Matthews - Collaborator - University Of Hull
Karen Windle - Collaborator - University Of Bradford
Louise Robinson - Collaborator - Newcastle University
Martin Knapp - Collaborator - London School Of Economics & Political Science
Matthew Prina - Collaborator - Newcastle UniversityOutcomes:
Primary and secondary care utilisation outcomes within the first 12/24/36 months following a diagnosis comprise: number of GP contacts, time to first hospitalisation, length of stay of first hospitalisation, number of hospitalisations, total length of all hospitalisations, number of critical care days, number of condition-specific/other medications and risk of mortality whilst in hospital.
Annual costs of primary care utilisation will be calculated using NHS reference costs.
Secondary care costs will be calculated according to national tariff prices using HRG codes and/or PSSRU unit costs.Description: Lay Summary
Everyone who lives with a progressive brain disease, such as dementia, will need some support from health care services. Despite a government policy aimed at reducing inequalities in access to these services, many local healthcare budgets have not increased and not everyone gets the same level of post-diagnostic care. Where you live makes a difference to the support available. Research shows that various things affect service use, including your ethnicity, where you live and your social class. Most pre-existing evidence is about dementia, with little known about patterns of service use for people living with other progressive brain diseases. There are also increasing pressures on the NHS in recent times meaning that the costs of providing these services are important.
Here we plan to use data from clinical records of people living with a progressive brain disease (including dementia, Parkinsonâs disease, Huntingtonâs disease and motor neurone disease) to see how much of a difference social class, ethnicity, and where you live makes to the health services used, and to calculate the costs related to this use. We will also see whether inequalities in accessing health care services are increasing over time.
This project will generate evidence about where resources should be directed in order to help reduce inequalities in health service use among people living with dementia and other progressive brain conditions.
Technical SummaryAlthough reducing inequalities in accessing health and social care has long been a policy aim in the UK, most areas have not seen an increase in budget to support any increased access to diagnosis, treatment and support. Services are therefore fragmented with access to them often described as a âpostcode lotteryâ.
People living with dementia have been found to have more avoidable service use, including hospital admissions and A&E access, compared with older people who do not live with dementia, and some initial evidence indicates changes in service use by socio and spatial demographics. Since these findings from 2016, several events including the COVID-19 pandemic have put further strain on health care services, possibly leading to further widening of inequalities among people living with neurodegenerative conditions.
This descriptive cohort study will estimate how primary and secondary healthcare resource utilisation differs by measures of inequalities, and the associated costs in people living with dementia or another neurodegenerative condition in England. Using CPRD and linked HES Admitted Patient Care data several outcomes will be investigated including number of GP visits, number of hospitalisations, time to first hospitalisation, and total time spent in hospital in the 12 months (and 24/36 months) since diagnosis. Measures of socio and spatial inequality include sex, GP region, ethnicity, IMD deprivation quintiles and urban/rural classification. Costs of service use will be generated from NHS reference costs, Personal Social Services Research Unit and NHS Digital prescribing costs as appropriate. We will also explore change over time in health service use by repeating the analysis at yearly intervals.
This project will generate evidence as to where resources should be redirected to reduce inequalities in health service utilisation among people living with a neurodegenerative condition, potentially informing both national and regional decisions.
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Treatment patterns of urinary tract infection among people with multiple sclerosis, rheumatoid arthritis, diabetes mellitus, and the general population — Ewoudt van de Garde ...
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Treatment patterns of urinary tract infection among people with multiple sclerosis, rheumatoid arthritis, diabetes mellitus, and the general population
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Ewoudt van de Garde - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Bernard Uitdehaag - Collaborator - VU Medical Centre
Marloes Bazelier - Collaborator - Utrecht University
Melissa Leung - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht UniversityOutcomes:
UTI-related events: recorded diagnoses and symptoms, antibiotic prescriptions, and urinary cultures
Description: Lay Summary
Multiple sclerosis (MS) is a disease where the immune system disturbs messages in the brain and spinal cord. People with MS often get more urinary tract infections (UTIs) than most people. Like people with MS, people with rheumatoid arthritis (RA, a condition where a person's immune system mistakenly attacks their own joints) and diabetes mellitus (DM, a condition where the body has trouble controlling the level of sugar in the blood) also get more UTIs. The UK guidelines for treating UTIs are the same for everyone, whether they have MS, RA, DM, or not. We don't know if doctors treat UTIs differently in people with these conditions compared to others.
Technical Summary
This study aims to compare how UTIs are treated in people with MS, RA, DM, and the general population. We will look at whether the treatment changes between new and repeated UTIs and if people with MS need to switch antibiotics more often and get more repeated UTIs. The results might show if the choice of antibiotic affects how often people with MS get UTIs again.The study may inform more effective antibiotic management of infections, which is of benefit to the public in light of better patient care and in light of preventing antimicrobial resistance to antibiotics.Multiple sclerosis (MS) is a chronic demyelinating disease. People with MS have a higher risk of urinary tract infection (UTI) than the general population. Similar to people with MS, people with rheumatoid arthritis (RA) and diabetes mellitus (DM) are at greater risk of UTI, and there are no guidelines for the treatment of UTI specifically for these populations. The aim of this study is to compare treatment patterns for UTI among people with MS to that among people with RA, DM, and the general population. As secondary objective, we will investigate whether MS is associated with antibiotic switch for UTI and UTI recurrence. The unit of analysis in this study will be GP-recorded UTI episode; the study âpopulationâ will include UTIs from everyone with a UTI between 1 April 2022 and 31 March 2023. We will (1) provide descriptive statistics on the treatment of UTI and (2) conduct a conditional logistic regression analysis on the association between MS and antibiotic switch in the treatment of UTI, and a conditional logistic regression analysis on the association between MS and UTI recurrence. The intended public health benefit is that the findings may inform treatment of UTI with lower probability of recurrence.
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Long-term survival following invasive pneumococcal disease: a matched cohort study — Edward Parker ...
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Long-term survival following invasive pneumococcal disease: a matched cohort study
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Edward Parker - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Edward Parker - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anne Suffel - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
Death from any cause; Death from cardiovascular disease; Death from non-cardiovascular causes
Description: Lay Summary
A bacteria called âpneumococcusâ is a major cause of severe infections including infections of the lung. Collectively, these severe infections are referred to as âinvasive pneumococcal diseaseâ (IPD). People who have IPD are at higher risk of dying than the general population of the same age, for months and even years after the infection. This may be because long-term medical conditions such as chronic levels of high blood sugar (diabetes) which make people more vulnerable to IPD also affect long-term survival. It is not known whether IPD itself increases the risk of death in the medium to long term, once the infection has passed.
This study will describe deaths following IPD, using anonymised national data reports for 14,000 people aged 65 or over years with confirmed IPD, which includes their long-term medical conditions as reported by their general practices. We will compare cases to a cohort of the general population aged 65 years or over drawn from the Clinical Practice Research Datalink (CPRD) database. We will compare deaths among cases (following IPD) to deaths among the general population, controlling for age, sex, and long-term conditions.
This analysis will help clarify whether poor survival after IPD is explained by the pre-existing health conditions of people who experience IPD, or whether it could be a long-term consequence of the IPD. This study will enable better understanding of the long-term consequences of IPD, and the benefits of vaccination against the bacteria responsible for IPD.
Technical SummaryCohort studies have found that 5-10 year mortality is high among survivors of invasive pneumococcal disease. However, previous studies have not adjusted for pre-existing comorbidities, which could explain this finding.
This study will compare survival among an anonymised UK Health Security Agency dataset of over 14,000 individuals aged 65 years or over with laboratory-confirmed invasive pneumococcal disease from 1 January 2012 to 31 December 2019, to a comparator cohort drawn from CPRD of members of the general population aged 65 years or over. The comparator cohort will be individuals aged 65 years or over and active in the Clinical Practice Research Database 2012-2019. The two datasets will not be linked, and both datasets will remain fully anonymised.
The study will use a matched cohort design to compare long-term survival among cases (from 120 days after infection onset to latest mortality data linkage for end of follow up) to long-term survival among the comparator cohort. Up to five comparators will be selected per case, matching on age and sex in calendar date order. Multivariable Cox or Poisson regression models will be used to adjust for deprivation, ethnicity, and co-morbidities.
This will enable better understanding of the long-term prognosis of IPD and inform improved estimates of the benefits and cost-effectiveness of pneumococcal vaccination.
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A feasibility study examining the availability of data to ascertain the case definition of Epidermolysis Bullosa, and describe key comorbidities. — Zoe Venables ...
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A feasibility study examining the availability of data to ascertain the case definition of Epidermolysis Bullosa, and describe key comorbidities.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Zoe Venables - Chief Investigator - University of East Anglia
Charlotte Davies - Corresponding Applicant - University of East Anglia
Jane Skinner - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Marta Kwiatkowska - Collaborator - University of East AngliaOutcomes:
Epidermolysis Bullosa (EB), related blistering diagnoses (e.g. Bullous pemphigoid, pemphigus), and common EB comorbidities (as determined by the Charlson Comorbidity Index and SCC, anxiety and depression).
Description: Lay Summary
This feasibility study forms the first part of work to study the epidemiology of Epidermolysis Bullosa (EB) in the UK, and how often patients with EB see their General Practitioners (GPs) and how they are managed, including what treatment they receive.
EB is a group of rare inherited skin disorders that cause the skin to become fragile and form blisters. It is usually diagnosed in babies and young children and in severe cases, can lead to early death. Little is known about how many people live with EB and how they are treated in the UK.
The work set out here proposes to examine the case definition of EB in primary care data using CPRD (Clinical Practice Research Datalink) Aurum and Gold, and in hospital level data using HES APC (Hospital Episode Statistics Admitted Patient Care). This preliminary work will establish a clear definition of EB which will be applied in a subsequent full CPRD application. Additionally, we will explore the definition of EB by key socioeconomic data including age, gender, ethnicity and Index of Multiple Deprivation (IMD). Once a clear definition is established, we will examine which comorbidities are most common in patients with an EB diagnosis.
The findings from this and the forthcoming full study are expected to enhance our understanding of the burden of EB in the UK, including case numbers, severity, treatments, and healthcare resources. This information will support future research, healthcare planning, and the development of new treatments for EB.
Technical SummaryWe aim to use CPRD Aurum and Gold, HES APC and IMD to explore the availability of data on definitions of EB according to age, sex, ethnicity, IMD quintile and common comorbidities.
Objectives are:
1. to examine counts of EB recorded by diagnosis in CPRD and/or HES APC, according to year, age group, sex, ethnicity and IMD quintile.
2. To help with the case definition, to examine the frequencies of patients with history of a related blistering diagnoses (e.g. Bullous pemphigoid, pemphigus, acquired EB)
3. To describe the frequency of the 10 most common comorbidities (from the Charlson Comorbidity index) and 3 comorbidities often associated with patients diagnosed with EB (depression, anxiety and squamous cell carcinoma (SCC)).
Only counts and percentages will be described.
HES APC linkage will allow us the fullest possible assessment of disease status and ethnicity.The findings of this feasibility stage of the study will inform the development of a full CPRD protocol which we anticipate will contribute to the evidence of the burden of EB to the NHS and also to the development of new treatments for EB.
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A descriptive study of epidemiology, somatic symptoms, comorbidities and treatment patterns in people with fibromyalgia in England using the Clinical Practice Research Datalink (CPRD) Aurum database — Moninder Kaur ...
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A descriptive study of epidemiology, somatic symptoms, comorbidities and treatment patterns in people with fibromyalgia in England using the Clinical Practice Research Datalink (CPRD) Aurum database
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-08
Organisations:
Moninder Kaur - Chief Investigator - UCB Pharma Ltd
Moninder Kaur - Corresponding Applicant - UCB Pharma Ltd
Bernard Lauwerys - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Chao Lu - Collaborator - UCB BioSciences, Inc.
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Fibromyalgia prevalence; fibromyalgia incidence; demographic characteristics including age, sex, region, referral status and socioeconomic deprivation; clinical characteristics including somatic symptoms related to fibromyalgia, number of GP consultations; specific comorbidities (cardiometabolic disorders i.e., myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, vascular dementia, dyslipidaemia, diabetes mellitus, hypertension, and inflammatory arthritis [i.e., rheumatoid arthritis, systemic lupus erythematosus [although systemic lupus erythematosus does not always include inflammatory arthritis], juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis]); comorbidity burden using Charlson comorbidity index score; pharmacological treatment patterns; non-pharmacological treatment patterns
Description: Lay Summary
Fibromyalgia is a condition where people experience long-lasting pain all over their body. They often also report other problems like headaches, feeling down, and trouble sleeping. The severity of fibromyalgia can vary, affecting how people go about their daily lives. Fibromyalgia severity is often established by how many other symptoms (like headaches and sleep problems) people report.
Technical Summary
We will find out how often people are diagnosed with fibromyalgia and how many other symptoms they report. We will investigate other health problems that people with fibromyalgia have. We will also explore what treatments people with fibromyalgia receive. It's important that we know this information so we can plan medical services.Our overall aim is to investigate the epidemiology of diagnosed fibromyalgia. We will estimate annual: 1) active prevalence (proportion of registered individuals with fibromyalgia recorded in specific year); 2) lifetime prevalence (proportion of registered individuals with new/existing fibromyalgia recorded in specific year); and 3) incidence (proportion of registered individuals with first-ever recorded fibromyalgia). We will describe characteristics (including consultations for somatic symptoms, comorbidities, treatment patterns) of people with a new fibromyalgia diagnosis. We will compare comorbidity burden in adults with fibromyalgia to matched comparators. This study will improve public health planning and resource allocation by providing insights into the healthcare needs of individuals with fibromyalgia.
We will use cross-sectional studies (2016-2022) to estimate annual prevalence and incidence. In individuals with incident fibromyalgia, we will describe comorbidities, estimate the proportion of people recorded with somatic symptoms at 12, 24 and 36 months after first fibromyalgia diagnosis, and records of potential treatments for fibromyalgia: 12 months before, and 1, 6, 12, 24 and 36 months after first fibromyalgia diagnosis.
In a matched cohort study (2016-2022) we will compare specific new and existing comorbidities in adults with and without fibromyalgia. We will match (age, sex, general practice, calendar date ) adults with fibromyalgia with up to five adults without. We will use logistic regression conditional on matched set to estimate odds ratios (95%CIs) comparing odds of existing comorbidity diagnoses on or before cohort entry (i.e., first fibromyalgia diagnosis date for those with fibromyalgia, and, for matched comparators, the cohort-entry date of their matched adult with fibromyalgia). We will use Cox regression stratified by matched set to estimate hazard ratios (95%CIs) comparing hazards of new comorbidity diagnoses in the 12 months after cohort entry. Regression analyses will be implicitly adjusted for age, sex, general practice and calendar time and explicitly adjusted for socioeconomic deprivation.
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Bone Health in people with Parkinson's: Risks of Osteoporosis and Fragility Fractures according to age and sex — Donald Grosset ...
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Bone Health in people with Parkinson's: Risks of Osteoporosis and Fragility Fractures according to age and sex
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-14
Organisations:
Donald Grosset - Chief Investigator - Parkinson's UK
Donald Grosset - Corresponding Applicant - Parkinson's UK
Cathal Doyle - Collaborator - Parkinson's UK
Katherine Grosset - Collaborator - Parkinson's UK
Lance Lee - Collaborator - Parkinson's UK
Prasanth Anand Iruthayaraj - Collaborator - Parkinson's UK
Romel Gravesande - Collaborator - Parkinson's UK
Syed Jaker Hussain - Collaborator - Parkinson's UKOutcomes:
Primary outcome in bone health in Parkinsonâs: Diagnosis of major osteoporotic fracture (limb, shoulder, vertebral)
Secondary outcomes in bone health in Parkinsonâs: Diagnosis of osteoporosis; Performance of bone densitometry scan; Prescription of anti-resorptive bone treatmentDescription: Lay Summary
People with Parkinsonâs (a brain disorder that causes slowness of movements and tremor) are more likely to have falls and thinning of their bones. Weak bones are more likely to fracture. There are treatments that improve bone strength and reduce the number of fractures, but not all people who could benefit from them are currently prescribed these treatments. We want to find out how many people with Parkinsonâs have bone fractures, how many are investigated with a scan that measures bone thickness, and how many are prescribed the preventive bone health treatments. We will compare the findings between people with Parkinsonâs and people without Parkinsonâs. We will use this information to highlight the need for early bone health assessment in everyone with Parkinsonâs, to get people on the right treatment, and reduce the number of bone fractures.
Technical SummaryWe will determine the incidence rates of osteoporosis, and major fragility fractures in people with Parkinsonâs, and compare this to age, sex, and GP practice controls in a matched cohort design. Hospital Episode Statistics (HES) admission data and CPRD data will be used to determine fractures (limb, pelvic, shoulder, and vertebral). HES Diagnostic imaging data will be used to determine DXA use and the radiological diagnosis of fractures, and GOLD and Aurum treatment data for cases prescribed bone health preventive treatment. The probability of experiencing fragility fractures during follow-up will be plotted using the KaplanâMeier method and differences between Parkinson's and matched controls examined using the log-rank test. The association between PD and a diagnosis of osteoporosis, and the occurrence of fragility fracture, will be examined using a matched cohort approach by fitting Cox regression models adjusted for known confounders. Modelling results will be expressed as adjusted hazard rate ratios (95% confidence intervals). Interactions between sex/gender x (age group, IMD, urbanicity) and age group x (IMD, urbanicity) will be explored. The incidence rates for cases of Parkinson's undergoing DXA scans and being prescribed bone health preventive therapy will also be analysed, compared to matched controls. Two sensitivity analyses will be conducted to evaluate whether the rates of osteoporosis and fragility fracture are similar across different patient populations: firstly, including cases with osteoporosis before the Parkinson's diagnosis, and, secondly, by excluding cases with fragility fractures before the Parkinson's diagnosis. The findings will be used to inform the ongoing national service improvement project in the UK Parkinsonâs Excellence network, and to reinforce the messages about the incorporation of bone health assessment into routine care with the wider healthcare professional community, and people with Parkinsonâs and their families.
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A retrospective database analysis of Pneumococcal Vaccination Coverage Rates and Burden of Disease among Adults in England, by Risk Category — Jay Were ...
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A retrospective database analysis of Pneumococcal Vaccination Coverage Rates and Burden of Disease among Adults in England, by Risk Category
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Jay Were - Chief Investigator - Parexel International Limited (UK)
Jay Were - Corresponding Applicant - Parexel International Limited (UK)
Amanda Martino - Collaborator - Merck & Co., Inc.
Ian Matthews - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Mateo Delclaux Rodriguez-Rey - Collaborator - Parexel International Limited (UK)
Salini Mohanty - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Smit Patel - Collaborator - Merck and Company, Incorporated
Yi Zheng - Collaborator - Merck Sharp & Dohme LLC
Yi-Ling Huang - Collaborator - Merck & Co., Inc.Outcomes:
Vaccination status (Number of patients vaccinated, Vaccination Coverage Rate), Number of patients diagnosed with Pneumococcal disease (PD) (with and with no record of a vaccination), Number of new cases of PD, Cumulative Incidence of PD (invasive pneumococcal disease (IPD), non-bacteremic pneumococcal pneumonia (NBPP), all cause pneumonia (ACP), Incidence rates of PD (IPD, NBPP, ACP), clinical outcomes (Case fatality rates (CFR) associated with PD (IPD, NBPP, ACP) admissions), Time to vaccination, healthcare resource use outcomes (GP appointments, prescriptions issued in primary care, outpatient appointments, A&E attendances, inpatient admissions, type of admission, mortality, inpatient length of stay, critical care unit (CCU) stays, inpatient HRG tariffs), cost (GP appointments, prescriptions issued in primary care, outpatient appointments, A&E attendances, inpatient admissions (All and CCU) stays), Number of IPD hospitalizations resulting in post-IPD sequelae (meningitis and sepsis), Socio-demographic and comorbidity profiles for vaccinated patients and those diagnosed with PD (Mean, median, minimum, and maximum age at vaccination or PD diagnosis, age, gender, ethnicity, BMI, total time in cohort, mean and median follow-up time, Charlson Co-morbidity Score, Geographic region) and Risk group. Proportion of patients at- high-risk of PD (age groups)
Description: Lay Summary
Streptococcus pneumoniae is a bacterium that causes invasive and non-invasive pneumococcal disease. Invasive pneumococcal disease (IPD) is defined as the existence of Streptococcus pneumoniae bacteria from a normally sterile site (e.g., blood or bodily fluids). Pneumococcal bacteremia, the presence of pneumococcal bacteria in the bloodstream can lead to serious complications. Risk factors for acquiring pneumococcal disease and/or experiencing more severe effects include those with chronic concurrent conditions such as chronic heart disease, chronic lung disease, chronic liver disease, being diabetic, alcoholism, current cigarette smoking, and asthma and those with immunocompromising conditions such as cancer.
The Joint Committee on Vaccination and Immunisation (JCVI) is the UKâs National Immunization Technical Advisory Group (NITAG). They review comprehensive evidence of and make recommendations about the use of vaccines in the country and recommend that the most at-risk adult patients receive pneumococcal vaccination at least once every 5 years to protect them from IPD.
Pneumococcal vaccine coverage among UK adults varies by age group and region. Despite JCVIâs recommendations for adult pneumococcal vaccination, many UK adults at risk for pneumococcal disease remain unvaccinated. Previous research indicates that the incidence of IPD continues to increase in the post-COVID era and pneumococcal pneumonia remains a driver of high healthcare utilization cost and clinical burden.
This study will provide an up to date and comprehensive assessment of the burden of adult pneumococcal disease in England and examine all the major pneumococcal disease manifestations in adults. This information will support the development of interventions for vaccine-preventable disease.
Technical SummaryStreptococcus pneumoniae is an encapsulated gram-positive bacterium that causes invasive and non-invasive pneumococcal disease. Invasive pneumococcal disease (IPD) is defined as isolation of S. pneumoniae from a normally sterile site (e.g., blood or cerebrospinal fluid). Complications of pneumococcal bacteremia may include arthritis, meningitis, and endocarditis.
Aside from older age (⥠65 years), additional risk factors for acquiring pneumococcal disease (PD) and/or experiencing more severe sequelae include those with chronic comorbid conditions such as chronic heart disease, chronic lung disease, chronic liver disease, diabetes mellitus, alcoholism, current cigarette smoking, and asthma and those with immunocompromising conditions, including cancer.
Despite The Joint Committee on Vaccination and Immunisation (JCVI) recommendations for adult pneumococcal vaccination, many UK adults at risk for pneumococcal disease remain unvaccinated. Previous research indicates that the incidence of IPD continues to increase in the post-COVID era and pneumococcal pneumonia remains a driver of high healthcare utilization cost and clinical burden. MSD have developed a 21-valent pneumococcal conjugate vaccine (V116) for the prevention of invasive disease, and non-bacteremic pneumococcal pneumonia caused by S. pneumoniae serotypes contained in the vaccine which is already approved in the US. To demonstrate the potential value of V116, it is important to quantify the residual and vaccine-preventable burden of invasive and non-invasive pneumococcal disease.
This descriptive retrospective observational cohort study aims to provide an updated and comprehensive assessment of the burden of adult PD in England in both outpatient and inpatient settings. The study will examine all the major PD manifestations in adults IPD, non-bacteremic pneumococcal pneumonia (NBPP) and all cause pneumonia (ACP). The study will also estimate healthcare resource utilization and costs associated with IPD episodes, as well as the incidence of post-IPD related sequalae. The results of this study can be combined with etiologic and serotype-specific data to inform the development of vaccine-preventable interventions.
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Assessing the Management of Diabetic Kidney Disease in UK Primary Care — Francesca Crowe ...
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Assessing the Management of Diabetic Kidney Disease in UK Primary Care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-10
Organisations:
Francesca Crowe - Chief Investigator - University of Birmingham
Francesca Crowe - Corresponding Applicant - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Srikanth Bellary - Collaborator - Aston University, BirminghamOutcomes:
The key outcomes for this study include assessing these in patients with T2D and CKD at index, 6-month, 12-months, and 18-months post-index, the:
1. Target for individual risk factors such as HbA1c (52-58 mmol/mol), SBP (10% and >20%
5. CVD (e.g. MI, stroke, heart failure), all-cause and heart failure specific hospitalization, all-cause mortality, and progression to ESRD
6. Patients fulfilling the DAPA-CKD study inclusion criteria (eGFR of 25 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000) and receiving SGLT2i
7. FIDELIO-DKD study inclusion criteria urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an eGFR of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area) and receiving selective nsMRADescription: Lay Summary
Diabetes is a health condition where level of sugar in the blood become too high and this can lead to other health problems such as chronic kidney disease (CKD), affecting nearly 40% of people with diabetes. Diabetes can also lead to kidney failure. Diabetic kidney disease gets worse over time as the kidneys stop working properly. In the past, controlling blood pressure and using certain medicines like angiotensin-converting enzyme (ACE) inhibitors were the main ways to slow it down. But now, there are new medicines (called sodium-glucose co-transporter-2 inhibitors (SGLT2) inhibitors and Mineralocorticoid Receptor Antagonists) that can help treat this condition and delay kidney failure.
Most people with CKD get treated by their GP, but not many people getting these new treatments. It's hard to know which patients need these treatments the most, so doctors sometimes don't start them. A simple way to figure out who needs these treatments could help a lot.
The proposed study aims to understand which patients need these medicine and suggest a simple way to manage their treatment based on risk scores. To do this, we will use a big database called the Clinical Practice Research Datalink (CPRD) to look at health information from people in the UK. We will try and understand who is getting these newer treatments and whether there are certain groups of patients not on these treatments who could benefit from them. The results will be shared with doctors, policy makers, and patient charities to improve treatment for people with CKD.
Technical SummaryChronic Kidney Disease (CKD) affects 40% of people with type 2 diabetes (T2D) and is a major cause of End Stage Renal Disease (ESRD). Efforts to slow CKD progression have focused on controlling risk factors and inhibiting the Renin-Angiotensin-Aldosterone System (RAAS). Newer therapies, such as SGLT2 inhibitors and selective non-steroidal MRAs, have shown improved heart and kidney outcomes. However, applying these benefits in everyday practice is challenging. A practical, risk-based management approach could help improve outcomes.
Objectives are to determine:
1. Proportion of patients within each CKD stage achieving the recommended multifactorial targets for individual risk factors (e.g. SBP, Cholesterol, HbA1c) and receiving reno-protective agents (e.g. ACEi/ARB, SGLT2i (including dose)) overall and within each category of Tangri kidney failure risk equation (Tangri-KFRE) score at the following cross-sectional time points:
a. Index
b. 6-months
c. 12 months
d. 18 months2. What proportion of patients within each CKD stage are at high risk of and experience cardiovascular disease events (e.g. myocardial infarction (MI), stroke, heart failure), all-cause and heart failure specific hospitalization, all-cause mortality and progression to end stage renal disease (e.g. as per NICE definition) overall and within each category of cardiovascular disease (CVD) risk using QRISK®-3 at the following cross-sectional time points:
a. Index
b. 6-months
c. 12 months
d. 18 monthsDetailed demographic, anthropometric, medical history and biochemical measures will be assessed in adults with T2D and CKD from 2005 to 2022. CVD and kidney failure risk will be estimated using validated risk equations eg QRISK®-3 and Tangri-KFRE. Data will be analysed to determine cohort characteristics and differences in outcomes between groups (eg sex, age, ethnicity) using multivariable regression in Stata.
This data is key to improving treatment and care for people with T2D and CKD, helping to identify high-risk groups and develop targeted strategies for better outcomes.
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Prescribing patterns of glucagon like peptide-1 receptor agonists in England 2007-2024 — Ruth Brauer ...
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Prescribing patterns of glucagon like peptide-1 receptor agonists in England 2007-2024
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-02
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Shaikha Alnaimi - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )Outcomes:
This is a descriptive study and the primary outcome is prescribing patterns of GLP-1 receptor agonists in England.
Description: Lay Summary
A group of medications known as glucagon-like peptide 1 (GLP-1) receptor agonists are used to lower blood sugar in patients with type 2 diabetes mellitus; a disease that causes abnormally high blood sugar levels. They can also be prescribed as weight-reducing medications for overweight or obese patients who are not able to lose weight with diet and exercise. Studies have shown that GLP-1 receptor agonists have other health benefits such as reducing the chance of death from heart disease and slowing the worsening of kidney disease. In England, these drugs can be prescribed by general practitioners. Given the health benefits of GLP-1 receptor agonists, we aim to explore the uptake of the prescribing of these medications in primary care. To do this, we aim to assess the prescribing rates of GLP receptor agonists using the Clinical Practice Research Datalink data. We will describe prescribing patterns, taking into account patient characteristics such as gender, age groups, socioeconomic status and those with diabetes or obesity. The findings of this study will show the prescribing rates of GLP-1 receptor agonists by general practitioners in England, and whether prescribing rates are higher or lower in patients with different characteristics. These findings can be used to track changes in the use of GLP1 receptor agonists over time.
Technical SummaryType 2 diabetes mellitus (T2DM) is the most common endocrine disease and is associated with a high disease burden. Poorly controlled T2DM leads to short and long-term complications and is a major contributor to cardiovascular disease and chronic kidney disease. Metformin is considered the first line anti-diabetic agent given its weight neutral effect and its efficacy in lowering glycated haemoglobin (HbA1c). Glucagon-like peptide 1 (GLP-1) receptor agonists are generally recommended as second-line or third-line anti-diabetic agents when response to a combination of oral antidiabetic agents is inadequate. They are especially preferred when weight loss is desired and in patients who would benefit from cardiovascular risk reduction. Due to their efficacy in weight reduction, GLP-1 receptor agonists are approved as pharmacologic intervention in obese patients or those who are overweight with obesity-related complications. Moreover, semaglutide has been recently shown to reduce cardiovascular mortality in obese patients without diabetes. Given the favourable risk-benefit profile of GLP-1 RA and its potential as a first-line drug prescribed by GPs to treat obesity, there is a need to describe real-world GLP-1 receptor agonists utilization in England. This information would provide insight on the current rate of GLP1-RA prescribing in primary care practices, which can support and provide evidence to inform policy makers.
We aim to describe the prescribing patterns of GLP-1 receptor agonists in England between January 2007 to the last available data in 2024. We will describe drug utilization and patient characteristics of GLP-1 receptor agonists using Clinical Practice Research Datalink (CPRD) Aurum. We will first describe the annual incidence rate of GLP-1 receptor agonists prescribing between 2007 and 2024; stratified by age groups, gender and type of GLP-1 receptor agonist. We will then describe the characteristics of patients with T2DM or who are overweight or obese stratified by comorbidities.
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The risk of frailty in urban and rural areas among the older population in England using a cross-sectional analysis — David Sinclair ...
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The risk of frailty in urban and rural areas among the older population in England using a cross-sectional analysis
Datasets:GP data, Practice Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-23
Organisations:
David Sinclair - Chief Investigator - Newcastle University
David Sinclair - Corresponding Applicant - Newcastle University
Andrew Kingston - Collaborator - Newcastle University
Barbara Hanratty - Collaborator - Newcastle University
Hilary Shepherd - Collaborator - Newcastle University
Laurie Davies - Collaborator - Newcastle UniversityOutcomes:
eFrailty Index score using a pre-coded algorithm
Description: Lay Summary
Frailty is a measure of a personâs vulnerability to negative health events and their ability to recover from them. Older people who are frail are more likely to use health and social care services and are at greater risk of death. While people tend to become frailer as they age, frailty is not an inevitable consequence of ageing. Frailty is a useful broad measure of older peopleâs health.
The 2023 Chief Medical Officerâs report highlighted the need to prioritise rural areas to provide services for an ageing population. However, investigations into frailty suggest that deprivation is strongly associated with the prevalence of frailty and urban areas are typically more deprived than rural areas in England. This raises the question of where public health resources should be targeted: rural areas with a more rapidly ageing population, or urban areas with potentially a frailer older population. We will investigate the risk of frailty in urban and rural areas, to help answer this question.
Technical SummaryFrailty is routinely measured in primary care in England. It identifies older people who are more vulnerable to severe outcomes from health stressor events. It also indicates those more likely to utilise health care services.
We will use CPRD data to investigate the risk of frailty among different population subgroups, to evaluate the difference in risk among the older population in urban or rural areas, as well as by deprivation, age and gender. Frailty will be measured with the e-Frailty Index, a measure of frailty that works well with electronic health records and has a track record of success use with CPRD data.
We will investigate the risk of frailty with a cross-sectional analysis and logistic regressions. This will provide useful insight into relative of risk of frailty this year, providing a chance to evaluate the benefit of prioritising rural areas for health and social care among older people, as suggested by the Chief Medical Officerâs report, 2023.
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Comparative effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1RA) among patients with type 2 diabetes mellitus — Samy Suissa ...
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Comparative effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1RA) among patients with type 2 diabetes mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-30
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
James Brophy - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Rachelle El Haber - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
⢠4-point major adverse cardiovascular events: myocardial infarction, ischemic stroke, heart failure hospitalization, and cardiovascular death
⢠3-point major adverse cardiovascular events: myocardial infarction, ischemic stroke, and cardiovascular death
⢠Myocardial infarction
⢠Ischemic stroke
⢠Heart failure hospitalization
⢠Cardiovascular death
⢠All-cause mortality
⢠Diabetic ketoacidosisDescription: Lay Summary
Type 2 diabetes is a serious condition caused by resistance to insulin, an important protein responsible for the regulation of blood sugar levels, which are elevated among people with diabetes. The occurrence of type 2 diabetes has increased dramatically in the last two decades. People with type 2 diabetes have a high risk of developing heart diseases. In addition to lowering blood sugar levels, medications used to treat type 2 diabetes, such as sodium-glucose co-transporter inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1RA), may reduce heart-related complications. There are limited studies investigating the effectiveness of these drugs compared to each other; such information will help clinicians make informed decisions regarding the management of type 2 diabetes among patients of different age, sex, and disease history. We will compare the rates of heart attacks, strokes, dying of heart-related reasons, and adverse events between patients who use these different drugs. We will use a database from the United Kingdom called the Clinical Practice Research Datalink which contains general practitioner medical records of over 40 million patients, linked to hospitalization and death records. This study will use novel cutting-edge statistical methods to ensure that our study results are valid.
The insights gained from our study will be invaluable for patients, doctors, and policymakers, empowering them to make more informed decisions about type 2 diabetes treatment. Ultimately, by determining the most effective medication, we can enhance the health and quality of life for individuals living with type 2 diabetes worldwide.
Technical SummaryType 2 diabetes mellitus (T2DM) poses a substantial global health burden, increasing the risk of macrovascular complications, notably cardiovascular diseases. Second-line therapies, including sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1RA), have demonstrated efficacy in reducing cardiovascular events in randomized controlled trials. However, the lack of direct comparative studies between these drug classes and methodological limitations in existing observational studies necessitate further investigation.
This study aims to evaluate the comparative effectiveness and safety of SGLT2i and GLP1RA in a real-world setting. Our approach involves assessing major adverse cardiovascular events and diabetic ketoacidosis between 2013 and 2024. We will utilize negative binomial and Cox proportional hazards models for incidence rates and hazard ratios estimation, respectively, considering subgroup analyses by age, sex, and cardiovascular disease history. Additionally, a mediation analysis will explore the potential influence of glycemic control on cardiovascular events using inverse probability weights and marginal structural models. Methodologically, we will employ a prevalent new user design to account for the dynamic nature of T2DM treatment and the active-comparator new-user designs for estimation of effectiveness within new users of treatment.
Ultimately, the findings from this study will provide crucial insights for informing reimbursement policies and clinical practice guidelines, empowering clinicians and patients to make well-informed decisions regarding T2DM management. This understanding of the comparative cardiovascular effectiveness of SGLT2i and GLP1RA may lead to improved health outcomes and quality of life for T2DM patients worldwide.
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Evaluation of the risks in unplanned hospital admissions in polypharmacy and frequent medication users and their characteristics — Tjeerd van Staa ...
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Evaluation of the risks in unplanned hospital admissions in polypharmacy and frequent medication users and their characteristics
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Tjeerd van Staa - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Munir Pirmohamed - Collaborator - University of Liverpool
Yuqi Wang - Collaborator - University of ManchesterOutcomes:
The primary outcomes of interest will be emergency hospital admissions as recorded in the Hospital Episode Statistics (HES) and, for the antibiotic cohort, infection-related complications. All-cause mortality will be based on the death recording in the GP EHRs (with sensitivity analyses conducted with death certificate records, where available). The definition for emergency hospital admissions will be similar to that used for the prediction tool QAdmissions. The emergency admission information will be derived from the method of admission field recorded for each hospitalisation including code 21 (accident and emergency), 22 (GP direct to hospital), 23 (GP via a bed bureau); 24 (consultant clinic), 25 (mental health crisis resolution team), and 28 (other means). Only emergency admissions where the admission date and discharge date were both recorded and where the admission date was on or before the discharge date will be included. The definition for infection-related complications will be similar as used in previous studies, including infection-related hospital admissions as recorded in HES and GP-recorded complications and adverse outcomes associated with either the infection or a possible adverse drug reaction to an antibiotic (such as renal failure). Secondary outcomes of interest will include the distribution of admission and discharge ICD diagnoses as recorded in HES.
Description: Lay Summary
A recent UK Government Review of Overprescribing of Medicines suggested that at least 10% of the current volume of medicines in the UK may be unnecessary. Some patients may receive many medicines if, for example, they suffer from multiple diseases (this is known as polypharmacy). Taking multiple medicines at the same time may increase the risk of side-effects. Patients may also receive multiple courses of antibiotics over time, which could cause the patientâs bacteria becoming resistant to the antibiotics. This study will help to target clinical improvement activities to those who need it most. An example of this is to help clinicians to find patients whose medications should be reviewed and checked by the clinicians. Anonymised electronic health records of frequent medication users will be analysed. The outcomes of interest will be emergency hospital admissions, particularly those admissions that may be related to the medicines. This study will look at the characteristics of frequent medication users and their patterns of medication use. We will evaluate possible risks of medication effects and explore methods that can help to determine whether these outcomes are likely to be related to the medications or to the patientâs diseases. We have already held discussions with primary clinicians on what information, in general, they would like to see to help their care of frequent medication users.
Technical SummaryA recent UK Government Review of Overprescribing of medicines highlighted the need to reduce prescribing as at least 10% of the current volume of medicines in the UK may be unnecessary. Elderly patients frequently receive multiple medicines, also known as polypharmacy. Patients may also receive multiple courses of antibiotics over time, while there are concerns of patientâs bacteria becoming resistant to antibiotics. Problematic polypharmacy can is associated with an increased risk of drug interactions and adverse drug reactions. A recent review concluded that evidence of the extent of problematic polypharmacy in the UK, and what interventions are effective is limited. The overall objective of this study is to identify opportunities to better target clinical improvement activities for polypharmacy patients and antibiotic users in general practice in order to provide tailored actionable feedback to clinicians. Specific aims of this study include to evaluate the characteristics of frequent medication users, their possible risks of medication effects and to Identify patient groups with specific medication exposures to be prioritised for clinical improvement activities such as structured medication reviews. This study type will be a cohort study with nested case-control studies and be hypothesis generating. The primary outcomes of interest will be emergency hospital admissions as recorded in the Hospital Episode Statistics. The main exposure of interest will be pattern of medication use (extent, dosage and type of polypharmacy and medicine class and type). Several analysis techniques will be used in this study including descriptive analyses, regression analyses evaluating the odds of hospital admission in exposed patients, estimating individual risks of outcomes, with assessment of fairness and bias of these medication-related risk prediction models, and clustering analyses of prescribing patterns over time including number of medications prescribed and changes in medication over time. This study is a continuation of three previously approved CPRD projects.
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To assess the effectiveness of pulmonary rehabilitation in people with asthma — Jennifer Quint ...
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To assess the effectiveness of pulmonary rehabilitation in people with asthma
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-01
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College London
Ebenezar Ndachi Effiang - Collaborator - Imperial College LondonOutcomes:
Number of exacerbations
Lung function - FEV1/FVC, FEV1 (%), FVC,
MRC dyspnoea score,
Healthcare resource utilisation,
BMI,
Mortality
Medication use including oral corticosteroids (OCS), inhaled corticosteroids (ICS), antibiotics, long-acting beta 2-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), short-acting beta-agonists (SABAs), prednisolone maintenance, montelukast, theophylline, azithromycin, antihistamine and nasal steroid.
Asthma controlDescription: Lay Summary
Asthma is a common respiratory disease that affects people over their lifetime. The disease affects peopleâs ability to breathe and if severe, to carry out normal daily activities. Asthma is classed into mild, moderate, and severe forms depending on how advanced the disease is, how frequent the symptoms occur, and how well the lungs work. People with asthma can reduce the chances of experiencing asthma attacks and disease progression by understanding and reducing their exposure to asthma triggers such as infections, cold, flu and allergies.
Technical Summary
Pharmacological interventions can help to improve the quality of life of people with asthma. These treatments can help to reduce asthma attacks, hospital admissions and healthcare costs. Non-pharmacological treatments are equally important in managing respiratory diseases. Pulmonary rehabilitation is currently used in chronic obstructive disease (COPD) and there is increasing evidence that it can be effective in asthma too. Pulmonary rehabilitation requires people with asthma to attend a programmed exercise training and education class once or twice a week for a period of 4-weeks or more. Although pulmonary rehabilitation is recommended for use in COPD, it has not been recommended for use in asthma because of inconclusive evidence. While recent studies have suggested that the evidence of pulmonary rehabilitation in asthma is not conclusive, many of these have not had clear designs and reporting methods and have mostly had small sample sizes. In this study, we intend to use a larger sample size to assess whether pulmonary rehabilitation is effective in managing asthma.Asthma is a chronic non-communicable respiratory disease which requires long-term management. Asthma is classified into mild, moderate, or severe based on the severity, frequency of symptoms, and lung function. For some people with asthma, the disease can be well controlled with minimal symptoms while others with uncontrolled disease may experience day to day symptoms that hinder their ability to perform day-to-day activities. Those who follow recommended treatment guidelines can experience less exacerbations, less emergency hospital admissions, and incur less healthcare costs. A recent systematic literature review suggested that there is moderate evidence that completing a pulmonary rehabilitation programme is associated with clinically meaningful improvements in exercise capacity and quality of life. While this review also concluded that pulmonary rehabilitation has minimal effect on asthma control, the certainty of evidence was low because of unclear reporting methods, small sample sizes, heterogenous study designs and interventions. Pulmonary rehabilitation is a programmed exercise training and education class attended by people with asthma once/twice a week for 4-week or more lasting at least 30 minutes per session.
This study will use routinely collected primary care data from Clinical Practice Research Datalink (CPRD) Aurum linked with Hospital Episode Statistics (APC and A&E, deprivation status (IMD) and Office of National Statistics (ONS) mortality data to investigate if pulmonary rehabilitation is associated with improvement in number of exacerbations, lung function (FEV1/FVC, FEV1 (%), FVC), MRC dyspnoea score, BMI and mortality. The study will explore these asthma outcomes comparing those who engage with pulmonary rehabilitation with those who do not. We will perform descriptive statistics using Poisson regression or negative binomial regression model with 95% confidence intervals and p-values. Causal inference analyses will be performed using inverse probability weighting (IPW) and standardization or g-formal methods.
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Socioeconomic inequalities in general practice workload for mental health and substance misuse: a cross-sectional study using primary care data in England — Helena Painter ...
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Socioeconomic inequalities in general practice workload for mental health and substance misuse: a cross-sectional study using primary care data in England
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Helena Painter - Chief Investigator - Queen Mary University of London
Helena Painter - Corresponding Applicant - Queen Mary University of London
Harriet Larvin - Collaborator - Queen Mary University of London
John Ford - Collaborator - Queen Mary University of London
Rohini Mathur - Collaborator - Queen Mary University of LondonOutcomes:
Primary outcome: GP workload attributed to patients with key mental health and substance misuse conditions. Measured as an annual consultation rate per patient, and annual consultation rate per practice and consultations for patients with mental health and substance misuse problems as a proportion of total consultations
Description: Lay Summary
People who live in poorer, or more disadvantaged, areas of the country tend to have worse health than people who live in richer areas. General Practitioner (GP) surgeries in poorer areas also get less funding and find it difficult to employ GPs.
Mental health problems and problems relating to alcohol and drugs cause are more common in poorer areas and lead to 20,000 deaths each year in England. We do not know how much extra time GP surgeries in poorer areas spend helping people with mental health problems, including drug and alcohol problems. Our research aims to explore the time GP surgeries spend with patients with mental health or alcohol or drug problems and compare rich and poor areas. These results will help policy makers better match funding with need.
We will answer this question by using two years of data from a large database with anonymous GP records for patients with a diagnosis of a mental health condition or alcohol or drug problems. We will look at the number of consultations these patients have each year and compare this in richer and poorer areas to see if there is a difference. We will use statistics to show if any difference we find is meaningful taking account of other reasons for a possible difference, such as age, gender and region.
Technical Summary
This project will give policy makers more information about unfair differences between rich and poor areas in the time required to help people with mental health, alcohol and drug problems.Background:
Mental health problems are one of the leading causes of morbidity in England and combined with substance misuse are responsible for 20,000 deaths a year. Mental illness and substance misuse are socially patterned, and these conditions are some of the biggest contributors to health inequalities. People living in more socioeconomically deprived areas live in poorer health and receive disproportionately less healthcare relative to their needs. This is exacerbated by increasing demands on general practice (GP) which are having the greatest impact in areas of greatest need. We aim to explore inequalities in general practice workload related to mental health and substance misuse in England. We will do this by measuring consultation rates and the proportion of GP consultations relating to mental health and substance misuse, and compare these across index of multiple deprivation (IMD) quintiles.Methods:
A cross-sectional study using linked primary care data from the clinical practice research database (CPRD) and linked small area data. Our study population will include adult patients with a diagnosis of a mental health condition or substance misuse between 1st June 2022 and 31st May 2024. We will measure 1) number of consultations per patient per year, 2) number of consultations per practice per year and 3) mental health and substance misuse consultations as a proportion of the total practice consultations. We will use descriptive statistics to explore differences in consultations across IMD quintiles and multivariable regression to compare the difference between most and least deprived areas adjusting for age, gender, ethnicity, number of GPs and region.Outcomes:
This study will provide an understanding of inequalities in GP workload for mental health and substance misuse, to support policy makers in distributing resources more equitably. This project will support a future NIHR fellowship application to conduct in-depth analyses of workload across the multidisciplinary team.
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Co-morbidities in people with intellectual disabilities and femoral fracture — Margaret Smith ...
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Co-morbidities in people with intellectual disabilities and femoral fracture
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-01
Organisations:
Margaret Smith - Chief Investigator - University of Oxford
Margaret Smith - Corresponding Applicant - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Gary Collins - Collaborator - University of Oxford
helen stewart - Collaborator - Oxford University Hospitals NHS Foundation Trust
Jan Blair - Collaborator - Dimensions (UK) Ltd
Katja Maurer - Collaborator - University of Oxford
Tim Holt - Collaborator - University of OxfordOutcomes:
Primary: Incidence of femoral fracture
Secondary: Incidence of hip fractureDescription: Lay Summary
People with intellectual disabilities (ID), namely those with Down syndrome (DS) and other conditions of intellectual impairment, have a higher rate of fracture and a younger age at fracture than the rest of the population. In the most recent and comprehensive studies, completed by our research group in the CPRD linked to the Hospital Episode Statistics database, we found that
Technical Summary
1) The difference between people with ID and without ID was particularly marked for femoral fracture (FF), both in children and adults, and for hip fracture (HF) in adults
2) Adults with DS had a risk of HF almost twice as high than other people with ID
Femoral fractures, of which hip fractures are the largest subtype, are particularly severe fractures for the individual as they almost invariably require hospitalisation, surgery, and extensive rehabilitation. Moreover, FF can be a manifestation of osteoporosis, hence of a generalised tendency to fracture. We wish to understand better the characteristics of people with ID who sustain FF and the factors that put them at risk. In this study, we aim to investigate the incidence of FF in people with ID in relation to potential risk factors, namely causes of ID (e.g. DS, other syndromes) and frequently associated disorders (e.g. epilepsy, cerebral palsy). Incidence of HF will be a secondary aim.
The overarching objective of our study is to provide the scientific evidence on which a prevention strategy for femoral fracture in people with intellectual disabilities could be designed in the future.Femoral fractures (FF), of which hip fractures (HF) are the largest subtype, are particularly severe fractures as they almost invariably require hospitalisation, surgery, and extensive rehabilitation. Moreover, FF can be a manifestation of osteoporosis. In our previous studies in the CPRD Gold and Aurum databases linked to the to the Hospital Episode Statistics (HES) database we found much higher rates of such fractures in people with intellectual disabilities (ID) compared to an age and sex matched population. Also, FF represented 3.9% and 11.2% of all fractures in children and adults with ID compared to 1.3% and 5.9% in children and adults without ID.
In this study, we aim to investigate the incidence of FF in people with ID in relation to potential risk factors, namely causes of ID (e.g. Down Syndrome, other syndromes) and frequent comorbidities (e.g. epilepsy, cerebral palsy). Incidence of HF will be a secondary outcome.
We will create three cohorts of people with ID: 1-17, 18-29 and ⥠30 years of age at entry. We will calculate frequencies of risk factors in each of those cohorts for people who do and donât develop FF. We will also estimate FF rates in people with/without each risk factor, and we will estimate hazard ratios using Cox proportional hazards regression. We will do the latter analyses in two cohorts by combining the two younger cohorts. As these are exploratory analyses we will estimate crude statistics and statistics adjusted for age and gender. We will select the ID population from the Aurum database. We will use the linked HES database for comprehensive capture of fracture events, the Index of Multiple Deprivation and the Ethnicity Record for description of the population and the Pregnancy Register to exclude diagnoses of ID made within the setting of antenatal screening.
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Vertebral Fractures in the English Health Service: A Descriptive Study on the Regional Distribution, Characteristics and Management of Patients with Vertebral Fracture — Matthew O'Connell ...
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Vertebral Fractures in the English Health Service: A Descriptive Study on the Regional Distribution, Characteristics and Management of Patients with Vertebral Fracture
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-01
Organisations:
Matthew O'Connell - Chief Investigator - King's College London (KCL)
Matthew O'Connell - Corresponding Applicant - King's College London (KCL)
Aicha Goubar - Collaborator - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Emma Clark - Collaborator - University of Bristol
Emma Godfrey - Collaborator - King's College London (KCL)
Emma Rezel-Potts - Collaborator - King's College London (KCL)
Frances Williams - Collaborator - King's College London (KCL)
Katie Sheehan - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Mark Ashworth - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Sarah Pope - Collaborator - St George's University Hospitals NHS Foundation TrustOutcomes:
Primary outcome
Incidence of VF diagnosisSecondary outcomes/analyses
Descriptive characteristics of VF patients:
Age; sex; ethnicity; diagnoses of back pain; osteoporosis; previous fractures; diagnoses of chronic conditions (Charlson comorbidity index [1]); electronic Frailty Index (eFI) [2]; smoking status, exercise level (from NHS health check; Index of Multiple Deprivation (IMD).Care related variables
Consultation frequency (pre and post diagnosis); referrals to secondary care; imaging type leading up to coding; further investigations post diagnosis; further referrals post diagnosis; non-pharmacological management of VF or osteoporosisPrescriptions
Anti-osteoporotic medications; analgesics; corticosteroids; hormone replacement therapyFuture health outcomes
Further fractures; mortality.Practice level characteristics:
Size of general practice; case-mix of patients in practice (age, sex, ethnicity); region of England.See outcomes, exposures and covariates for more detailed specification and description of roles in the analysis.
Description: Lay Summary
A break or fracture in a bone of the back can be the first sign of weakened bones (osteoporosis). If they are not treated it is likely the person will break more bones such as their hip. Unfortunately, most people who break a bone in their back in this way are not treated because the broken bone is not picked up by doctors or other healthcare professionals.
We will investigate health records from general practices across England to see how many people had a broken bone in their back detected, and whether this depended on where they live. We will then describe these people â how old they were, whether they were men or women and their ethnic background. We will also describe what healthcare they received before and after their break was picked up, how many times they saw their doctor and what other health problems were diagnosed.
We will learn from those whose broken bone in their back was picked up, to help diagnose more people who have this injury in the future, and to understand what treatment can be given. Our findings will determine which groups of people are more likely to have a broken bone picked up, and which are not, and whether this is different across regions of the country. This will allow doctors to better identify which of their patients may have these broken bones, allowing them to begin medicine to prevent more serious broken bones in the future.
Technical SummaryVertebral fractures (VF) are the most common form of osteoporotic fracture and are associated with future fractures, including serious health events like hip fracture, and increased risk of mortality. Treatment with anti-osteoporotic medications can substantially reduce the risk of future fractures and their negative sequalae. However, 70% of VF do not reach clinical attention due to the non-specific nature of symptoms like back pain and consequent lack of onward referrals for high-risk patients. We aim to estimate the incidence of VF diagnosis across England, and describe the characteristics, pre and post diagnosis health care contact, management and outcomes of these patients.
We will use data from CPRD Aurum for this descriptive observational study to estimate the incidence of VF diagnosis in primary care patients aged 50 and older across the 9 regions of England and describe the cohort of diagnosed patients, the service contact and treatment received before and after diagnosis and their future health outcomes (further fractures, mortality). Age and sex-standardised incidence of VF diagnoses will be calculated by region using the CPRD Aurum population as denominator. Characteristics of newly diagnosed VF patients (age, sex, ethnicity, deprivation, frailty, presenting complaint(s), medical history) and primary care health contact prior to diagnosis (consultation rates and providers, referrals to secondary care, and imaging type leading up to coding) will be summarised using descriptive statistics. Associations between VF management, future fractures and mortality will be modelled using multilevel Poisson and Cox Proportional Hazards models to model variation at the practice and regional levels.
Identifying which patients obtain a diagnosis of VF will help to identify higher risk underdiagnosed patients, while differences in diagnosis rates among high-risk patients across regions will help the development of targeted interventions for poorer performing regions.
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Utilization and long-term persistence of oral anticoagulants among patients with atrial fibrillation and cancer: a descriptive study — Samy Suissa ...
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Utilization and long-term persistence of oral anticoagulants among patients with atrial fibrillation and cancer: a descriptive study
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Collaborator - McGill University
Joseph Junior Damba - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Sarah Beradid - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Yearly incidence rates of patients newly prescribed OACs in patients with AF and cancer; Factors associated with OAC initiation; Proportion of OAC discontinuers among OAC initiators; Proportion of OAC switchers among OAC initiators; Cumulative incidence of discontinuation; OACs will be identified using BNF dictionary
Description: Lay Summary
Atrial fibrillation (AF) is an irregular heart rhythm affecting about 1% of the global population, particularly common among older adults and those with age-related conditions like cancer. Individuals with both AF and cancer have a higher risk of stroke (blood clots in the brain) compared to those with only AF. To help prevent the formation of brain blood clots, these patients are prescribed medications called oral anticoagulants (OACs). OACs are blood thinners and include vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs). DOACs are as effective and safe as VKAs, but they have fewer interactions with food and other drugs, making them easier to use. Since their approval, DOACs have become increasingly prescribed among people with AF. However, there is limited information on the use of OACs in individuals with both AF and cancer. Most existing studies cover the period from 2010 to 2019, a time when some DOACs, like edoxaban (approved in 2015), were newly available. Additionally, the factors influencing the start of OAC therapy and the long-term use of OACs in patients with both AF and cancer are not well understood. This study aims to address these gaps by examining OAC prescribing trends over time, assessing factors linked to the initiation of OAC therapy, and evaluating the long-term use of OACs in individuals with both AF and cancer.
Technical SummaryAlthough the use of oral anticoagulants (OACs) has been extensively studied among individuals with atrial fibrillation (AF), little is known about their use in those with both AF and cancer. This study aims to describe OAC prescribing trends in this population from 2010 to 2023 in the UK primary care. We will also identify factors associated with OAC initiation and the long-term persistence of OAC use. A cohort study will be conducted using CPRD data, including all patients aged 50 years or older diagnosed with AF between 2010, and 2023, who also have a cancer at or before AF diagnosis. OACs studied will include vitamin K antagonists (VKAs) such as warfarin, phenindione, and acenocoumarol, as well as direct OACs (DOACs) such as dabigatran, rivaroxaban, edoxaban, and apixaban. We will calculate crude annual incidence rates of new OAC prescriptions, including each DOAC individually, among patients with AF and cancer in the year following AF diagnosis. The numerator will be the number of new OAC users each calendar year, while the denominator will be the total person-time of follow-up for all patients with AF and cancer up to the first OAC prescription within the specified year. These annual prescription rates, along with their corresponding 95% confidence intervals, will be estimated using negative binomial regression, and stratified by sex, age, cancer type, metastasis, index of multiple deprivation and UK nations. Factors associated with OAC initiation will be assessed using logistic regression. To evaluate OAC persistence, we will calculate the proportion of OAC discontinuers and switchers (including switches from VKAs to DOACs, from DOACs to VKAs, and among different DOACs). Cumulative incidence of discontinuation of DOACs and VKAs will be illustrated using Kaplan-Meier curves. Findings from this study will inform prescribing practices over time in UK primary care practices and ultimately improve patient care.
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Use of menopausal hormonal therapy and risk of cardiovascular disease: protocol for case-control study using CPRD — Yana Vinogradova ...
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Use of menopausal hormonal therapy and risk of cardiovascular disease: protocol for case-control study using CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-16
Organisations:
Yana Vinogradova - Chief Investigator - University of Nottingham
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of NottinghamOutcomes:
First record of: cardiovascular disease event; acute myocardial infarction; ischaemic stroke; transient ischaemic attack.
Description: Lay Summary
During menopause womanâs ovaries stop working normally and the lower levels of the reproductive hormones, particularly oestrogen, stop her periods. This change also cause troublesome side-effects, such as hot flushes, mood changes, joint pains, sleep disturbance, and vaginal dryness. Some women are very badly affected and can find the problems life-changing.
Many women suffering from menopausal side-effects benefit from menopausal hormone therapy (MHT or known in the UK as âHormone Replacement Therapyâ or HRT), which can eliminate or lessen these.
Changes in reproductive hormones can affect the heart and blood vessels, so low levels of these hormones after the menopause may affect the risk of heart attacks and strokes. Previous studies have suggested that the risks may be higher among some women who have used MHT/HRT. It is not yet clear, however, either whether this is true only for certain women, or whether or how risk levels may differ between specific treatments.
This study will reveal whether the risks are different for women currently on HRT/MHT or stopped in the past. This study will produce detailed information whether specific treatments change the risks. It will also investigate differences between different groups of women in relation to HRT/MHT treatments.
Our aim is that the information generated will improve understanding among patients and their doctors about the benefits and risks of using different MHT/HRT treatments, and lead to better prescribing choices.
Technical SummaryAim:
To estimate risks of acute cardiovascular disease (CVD) events (ischaemic stroke and myocardial infarction) associated with current and previous use of the range of menopausal hormone therapy (MHT) used in the UK National Health Service.Methods:
⢠The proposed study will use CPRD (both GOLD and AURUM). Where practices contribute to both parts only data from GOLD will be used.
⢠This will be a nested case-control study. Every woman aged between 40 years and 100 years with a first record of CVD between 1998 and 2024 (case) will be matched by age and practice to up to 5 female controls with no records of CVD at the time of the case diagnosis (index date). Cases will be selected using general practice, ONS mortality and HES data.
⢠Associations between different uses of MHT (types, applications, different hormones, doses, durations of use, gap after the last use) will be assessed using conditional logistic regression.
⢠All available relevant potential factors (confounders) including demographics and CVD risk factors will be taken into account, and details of exposure to different types of MHT treatments will be assessed.
⢠Subgroup analyses for cases with myocardial infarction and ischaemic stroke will also be conducted.
⢠Risks related to patient characteristics (ethnicity, age and body mass index) will be investigated by subgroup analyses.Impact:
The study will provide detailed and consistent information on the included CVD risks for different MHT hormonal preparations, describing those with higher or lower risks of developing CVD outcomes. The resulting detailed information on the risk estimates for included CVD events associated with different MHT treatments, taking into account both durations of treatment and intervals since the last use, will provide important additional data to inform decisions about menopause treatments and the need for wider access to such treatments.
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A retrospective analysis of the healthcare and clinical burden of travel-related dengue in England between 2010 and 2023 using linked data from the Clinical Practice Research Datalink and Hospital Episode Statistics — Jennifer Davidson ...
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A retrospective analysis of the healthcare and clinical burden of travel-related dengue in England between 2010 and 2023 using linked data from the Clinical Practice Research Datalink and Hospital Episode Statistics
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-02
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Andre Ng - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Bojana Milovanovic - Collaborator - Takeda Pharmaceuticals International AG
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Indraraj Umesh Doobaree - Collaborator - Takeda UK Limited
Rebecca Joseph - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Tracy Leong - Collaborator - Takeda Development Centre Europe Ltd. ( UK )Outcomes:
Incidence of hospitalised dengue; Number of all-cause and dengue-related hospital admissions; Cost of all-cause and dengue-related hospital admissions; Length of stay for all-cause and dengue-related (i.e., specifically coded as dengue or complications related to dengue) hospital admissions; Number of all-cause and dengue-related intensive care unit (ICU) admissions; Cost of all-cause and dengue-related ICU admissions; Length of stay for all-cause and dengue-related ICU admissions; Number of all-cause and dengue-related outpatient appointments; Cost of all-cause and dengue-related outpatient appointments; Number of all-cause emergency care (EC) attendances; Cost of all-cause EC attendances; Number of all-cause and dengue-related primary care consultations; Cost of all-cause and dengue-related primary care consultations; Cost of all-cause and dengue-related total healthcare use (primary and secondary care); Number of patients with certified sickness in primary care; Baseline characterisation; Treatment of hospitalised dengue; Occurrence of complications after hospitalised dengue; Case fatality rate; Setting of first presentation for dengue; Time between primary and secondary care presentation; Number of tests for dengue; Incidence of primary suspected dengue with a negative test results or suspected dengue with subsequent positive result or diagnosed dengue; Referrals to secondary care; GP practices with patients with dengue
Description: Lay Summary
Dengue is an infection that can be transmitted from mosquito to humans and can cause fever. Its occurrence is increasing worldwide. The mosquitoes that spread dengue already live in many popular tourist destinations and are spreading to other newer areas. Travellers returning to England from these places are at risk of dengue, with symptoms starting 3 to 14 days after first infection. Serious illness due to dengue can lead to hospitalisation due to, for example, bleeding or seizure.
We will use anonymised linked primary and secondary care health records as well as death records to determine how many people in England got dengue and were hospitalised as well as died within the last 14 years. We will also describe the amount of health service interactions and cost for dengue patients receiving care, including treatments.
This research will provide clinical and public health audiences with insight into dengue burden in England, which is currently not well defined, to help tackle this public health issue with the aim of advancing management of the illness as the number of people getting dengue increases worldwide.
Technical SummaryThe occurrence of dengue is increasing worldwide, with a 85.5% increase globally from 1990 to 2019. Dengue is a mosquito-borne viral disease transmitted by Aedes mosquitoes, populating endemic regions and popular tourist destinations in South East Asia, South Asia, Latin America and Africa. Ongoing geographical expansion of the Aedes mosquito increases dengue risk in non-endemic areas like France, Italy, Spain, Portugal, and Germany .
Dengue is now one of the most frequently diagnosed infections in travellers returning to England. Presentation of dengue in returning travellers is geographically dispersed, leaving healthcare professionals with low awareness of the infection and its consequences given their limited prior experience of treating patients with the infection. Dengue mostly presents as a mild febrile illness, however, severe illness can result in hospitalisation with complications like bleeding, seizure, encephalitis, Guillain-Barré syndrome and mononeuropathies.
There is a lack of published studies examining the clinical and economic burden of travel-related dengue in England. Understanding the burden of dengue on the healthcare system in England and its clinical presentation will facilitate awareness raising among healthcare professionals and travellers, and adopting preventative measures.This research seeks to use routinely collected primary and secondary healthcare data from the Clinical Practice Research Datalink Aurum database, linked to the Hospital Episode Statistics and Office for National Statistics death registrations, to estimate the incidence and case fatality of hospitalised dengue and describe its trends between 2010 and 2023 stratified by year, age, ethnicity, and region. We will also describe the characteristics of people with hospitalised dengue, and the number and percentage of people with hospitalised dengue who have clinical complications and receive treatments. Associated healthcare resource use will be summarised (using means and medians). Additionally, this study will describe the setting of presentation for dengue, dengue tests performed in primary care, and dengue patient pathway.
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Drug utilization for the management of polycystic ovary syndrome: a descriptive study — Samy Suissa ...
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Drug utilization for the management of polycystic ovary syndrome: a descriptive study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-04
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Michael Dahan - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Samantha Shapiro - Collaborator - McGill UniversityOutcomes:
Prescription prevalence; prescription rate; prescription duration.
Description: Lay Summary
Polycystic ovary syndrome (PCOS) is a disease that causes imbalanced hormone levels, irregular periods, and cysts on the ovaries. It is one of the most common conditions among females, and many patients with PCOS have a wide range of other health problems. No medications exist specifically for PCOS, but medications for other diseases are used to manage PCOS. There is very little data describing medication use among those with PCOS. The purpose of this study is to indicate which drugs are used in the treatment of PCOS, how strongly they are used, and the types of patients they are used in. The findings of this study will help to provide a more complete understanding of how drugs are used to treat PCOS.
Technical SummaryPCOS has a diverse range of symptoms that are often treated with a variety of pharmacological agents. A wide range of clinical practice guidelines for PCOS exist with significant heterogeneity in their recommendations. No medications have been approved by regulatory agencies specifically for the treatment of PCOS, and medication use in this population is therefore frequently off-label. Few studies describe medication use in this population, and the existing data is also rather macroscopic and provides little to no information on treatment patterns following diagnosis, differences in medication use by patient age or PCOS symptoms, or temporal trends in treatments.
To address this knowledge gap, we will assemble a cohort of patients newly diagnosed with PCOS and follow them from PCOS diagnosis until end of registration with the CPRD, end of the study period, or death. During the follow-up period, we will identify prescriptions for combined oral contraceptives, progestins, clomiphene, tamoxifen without an indication of breast cancer, aromatase inhibitors without an indication of breast cancer, androgen receptor antagonists, androgen synthesis inhibitors, gonadotropin modulators, spironolactone, retinoids, tetracycline or macrolide antibiotics with a concurrent acne diagnosis, and metformin, all considered separately. PCOS diagnoses and drug prescriptions will be identified using CPRD GOLD and Aurum. We will generate descriptive statistics to summarize characteristics of patients at the time of their PCOS diagnosis. Then, separately for each drug and by five-calendar year blocks in the study period, we will assess the prevalence, intensity, and persistence of medication use. We will also conduct additional analyses stratifying by age (â¤50 vs. >50 years old, as a proxy for menopause) and by clinical manifestation of PCOS (hyperandrogenism, polycystic ovaries, menstrual dysfunction). This research will help to fill the knowledge gap regarding pharmacological treatment of PCOS.
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A Cohort Study Investigating the Relationship Between Gout Flares and Serum Urate in English General Practice — Samuel Finnikin ...
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A Cohort Study Investigating the Relationship Between Gout Flares and Serum Urate in English General Practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-10-08
Organisations:
Samuel Finnikin - Chief Investigator - University of Birmingham
Samuel Finnikin - Corresponding Applicant - University of Birmingham
Christian Mallen - Collaborator - Keele University
Edward Roddy - Collaborator - Keele UniversityOutcomes:
The primary outcomes will be:
1) Gout flares, which will be defined according to criteria previously used in the literature.
2) Serum Urate Levels; latest before index gout episode and all subsequent measurements.Description: Lay Summary
Gout affects 2-3 out of every 100 people in the UK and causes episodes of painful joint inflammation called flares. These flares occur when crystals of monosodium urate are formed in the joints which form due to the presence of uric acid (or urate) in the blood. It is understood that when the urate levels in the blood rise, there is an increased chance that crystals will form in the joint causing a gout flare. However, serum urate levels are not routinely measured in people without gout and are inconsistently measured in people with gout, so the relationship between urate levels and gout is not fully understood. Also, the chances of having a gout flare is variable throughout the year. It is not known whether this is due to variations in serum urate levels or due to other factors.
This research aims to better understand the relationship between urate levels and gout flares. We will create a cohort of people with gout use routinely collected data to establish when they have a flare of their gout and if they have their serum urate levels measured. We will then describe the relationship between gout flares and serum urate, and how this changes over the year. This will help patients and clinicians better understand gout and when, and why, flares occur.
Technical SummaryThis study will explore the relationship between gout flares and serum urate levels in an English general practice population. Gout is the most common inflammatory arthritis in the UK there but still uncertainties about its epidemiology and pathophysiology. The relationship between raised serum urate levels and the chances of a gout flare is well established and there is evidence that the incidence of gout flares demonstrates some seasonality. However, the seasonality (or not) of serum urate levels is not well studied.
It is also thought that serum urate levels drop during a gout flare and this is the rationale behind delaying testing of serum urate until 14 days after a flare. We know that serum urate testing is suboptimal, and this time delay may be a barrier to getting serum urate testing done.
This research will aim to establish the relationship between serum urate and gout flares and any seasonality that exists. It will also inform decisions about the timing of serum urate testing in relation to gout flares.
To address this research question, a cohort of incident gout patients will be created. Any subsequent gout flares will be identified using established methods and all serum urate levels will be identified. Patients on urate lowering therapy (ULT) will be excluded and any initiated on ULT will be censored.
The flare rate and seasonality will be described and tested using chi-squared test of fit. Logistic regression will be used to calculate odds ratios for the months of the year with confounder variables of age, sex and ethnicity and rates will be described using these categories. Mean serum urate levels will be similarly described. Urate levels in the 30 days prior to, or post, a gout flare will be illustrated graphically. Rates of urate testing will be described over the study period.
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ID-426: TRICORDER-PLUS — Imperial College Healthcare NHS Trust...
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ID-426: TRICORDER-PLUS
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart health.
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ID-429: Combating Substance Misuse — Westminster City Council...
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ID-429: Combating Substance Misuse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-24
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Substance misuse.
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ID-430: Changing Futures JSNA — Westminster City Council...
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ID-430: Changing Futures JSNA
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-24
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: missing.
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ID-428: Climate Change JSNA — Westminster City Council...
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ID-428: Climate Change JSNA
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-24
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Climate change.
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ID-425: Exploration of patient characteristics and inequities in healthcare presentations and testing for infectious gastroenteritis — Imperial College Healthcare NHS Trust...
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ID-425: Exploration of patient characteristics and inequities in healthcare presentations and testing for infectious gastroenteritis
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Infectious gastroenteritis.
Source
2024 - 09
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Comparing data fusion methods for combining clinical trial and real-world data to estimate cardiovascular outcomes: a methodological study — Andrea StorÃ¥s ...
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Comparing data fusion methods for combining clinical trial and real-world data to estimate cardiovascular outcomes: a methodological study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-06
Organisations:
Andrea Storås - Chief Investigator - Novo Nordisk A/S
Andrew Thompson - Corresponding Applicant - University of Liverpool
Chris Holmes - Collaborator - University of Oxford
Jens Tarp - Collaborator - Novo Nordisk A/S
Morten Medici - Collaborator - Novo Nordisk A/S
Robin Evans - Collaborator - University of Oxford
Xi Lin - Collaborator - University of OxfordOutcomes:
Evaluation of data fusion methods will be achieved by estimating the risks at 2 years for the primary and secondary study endpoints from the DEVOTE trial. The primary endpoint is a composite of major adverse cardiovascular events. The secondary endpoint is an expansion of the primary endpoint that also includes unstable angina pectoris leading to hospitalization. An additional secondary endpoint consists of the primary endpoint, but where death from any cause is applied instead of death from cardiovascular causes. The reason is that the exact death cause is not always reported in observational data. The events are defined using ICD10 codes in the Hospital Episodes Statistics (HES) Outpatient Data, HES Admitted Patient Care Data, and Office for National Statistics (ONS) Death Registration Data. The primary and secondary endpoints are defined in section M Exposures, Outcomes and Covariates.
Description: Lay Summary
Diabetes is a disease where the body does not react normally to sugar. Patients living with acquired diabetes (type 2 diabetes) must sometimes reduce their levels of blood sugar by taking drugs mimicking the effect of a hormone called insulin. It is important to ensure that these drugs are safe for patients with diabetes. Consequently, drug companies invite individuals to trials to test the drugs and compare against taking no drug or taking an already available treatment. In the DEVOTE trial, the safety of two insulin-mimicking drugs were compared. However, such trials take a long time to complete, the information is restricted to the trial specifications and the participating individuals might not represent the population that will use the drugs in the real world. It is possible to get more knowledge about a drugâs safety by including data routinely collected through doctor visits and hospital admissions. In this methodological study, we combine real-world data from people examined in primary care in the United Kingdom (CPRD database) with trial data from DEVOTE to look at the safety of two insulin-mimicking drugs of interest. The main goal of the study is to increase our knowledge about methods that utilize more data from a real-world setting. This could impact future trials testing the effect and safety of new drugs by reducing the number of patients needed to be involved in lengthy trials and contribute to faster patient access to better treatments.
Technical SummaryRandomized controlled trials (RCTs) are regarded as the gold standard for determining efficacy and safety of new drugs, but can be time-consuming, lack patient diversity and challenge ethical aspects regarding recruitment of patients to a control group. Augmenting RCTs with real-world data (RWD) is an attractive solution that can lead to more accurate outcome estimates in terms of narrower confidence intervals, and with trial designs requiring fewer participants. Type 2 diabetes (T2D) is a metabolic disease with increasing prevalence world-wide. Patients with T2D must sometimes administer insulin analogues to sufficiently control their blood glucose. The DEVOTE trial provided evidence of cardiovascular safety for the long-acting insulin analogue degludec when compared to insulin glargine.
Our methodological study compares fully automated data fusion methods for combining RCT data from DEVOTE with RWD from CPRD to estimate the cardiovascular safety of the trial drugs. Data fusion analysis will primarily apply targeted maximum likelihood estimators, PROCOVA, a mean squared error minimizing method and a data-adaptive power likelihood method, but it will also include a secondary exploration of additional methods. The primary study objective is to compare and evaluate multiple fully automated data fusion methods. The impact of including RWD from CPRD for estimating cardiovascular safety of the trial drugs is also assessed. Individuals with T2D are included and followed until the first occurrence of either death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, unstable angina leading to hospitalization or end of follow-up. Patient-level information from Hospital Episodes Statistics and Office for National Statistics Death Registration are used to obtain the relevant events. The results will be valuable for future data fusion studies and can contribute to guidelines on leveraging RWD for more timely, relevant and accurate estimates of drug efficacy and safety, benefiting patients, clinicians and governmental bodies.
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Providing more accurate predictions of colorectal cancer prognosis: development and application of novel methodology when using electronic health record data for disease prognosis — Aiden Smith ...
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Providing more accurate predictions of colorectal cancer prognosis: development and application of novel methodology when using electronic health record data for disease prognosis
Datasets:GP data, NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-24
Organisations:
Aiden Smith - Chief Investigator - University of Leicester
Aiden Smith - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Farah Khasawneh - Collaborator - University of Leicester
Karen Brown - Collaborator - University of Leicester
Mark Rutherford - Collaborator - University of Leicester
Paul Lambert - Collaborator - University of Leicester
Timothy Morris - Collaborator - University College London ( UCL )Outcomes:
1. 1-, 3-, 5- and 10-year relative survival, where relative survival is a measure that compares the observed survival of a group of patients diagnosed with a specific disease, typically cancer, to the expected survival of a similar group from the general population without the disease, isolating the impact of the disease on survival. (stratified by deprivation, age group, sex);
2. 1-, 3-, 5-, and 10-year all-cause survival (stratified by deprivation, age group, sex, cancer treatment, BMI, smoking status, cancer treatment options, ethnicity, comorbidity status);
3. 1-, 3-, 5-, and 10-year crude probabilities of death (stratified by deprivation, age group, sex, cancer treatment, BMI, smoking status, cancer treatment options, ethnicity, comorbidity status);
4. Prognostic model performance metrics:
a. Brier Score
b. Calibration Slope
c. Calibration-in-the-large
d. Discrimination
e. Index of Predictive Accuracy5. Hazard ratios of model predictors;
6. Optimal lookback window for inclusion of multimorbidity as a prognostic factor;
Description: Lay Summary
Risk prediction models use personal traits (like age or disease stage) to work out how likely someone is to survive after being diagnosed with a disease, such as cancer. Doctors use these models to decide how best to care for a given patient. It is important for these models to be developed using data which reflects society. For example, if certain ethnicities arenât considered, the model may predict outcomes for these people which are incorrect. It is important that these predictions are reliable, and many factors can impact how well these models perform, such as: being developed on data that doesnât represent the target population, the impact of missing or outdated data, or the impact of risk factors (like cancer stage) changing over time.
Having complete data is important for the accuracy of these models. When data is missing, the models become less reliable. Missing data is common in healthcare settings. Data is collected when people visit the doctor or go to hospital. If someone is healthier and doesnât visit the doctor as much, their records will have less data. This data will also be less up to date. This can affect how well prediction models work.
There are 3 main aims to this project:
1. Assess the impact that missing data, and the way itâs missing, affect model outcomes
2. Understand how having other health conditions alongside cancer alter a person's outcomes
3. Improve how disease survival gets reported, and ensuring these models serve everyone equally, including minority groups
Technical SummaryPrognostic models aid healthcare providers in estimating disease risk, and inform clinical decision making. Model-based survival estimates often fail to account for the presence of time-dependent effects, leading to invalid predictions. By utilizing large-scale electronic health records these models can be developed in populations that are theoretically representative of a whole population, whilst avoiding under-sampling. However, EHRs are vulnerable to data quality issues, including informative missingness, which impact model estimates. Some population subgroups are underserved by these predictive models. Ensuring equitable healthcare for all is vital.
Aims:
i. Develop and validate a prognostic survival model for bowel cancer, accounting for variation in ethnicity and multimorbidity status
ii. Utilize flexible parametric modelling to create more accurate survival predictions following a diagnosis of bowel cancer, incorporating time-dependent effects
iii. Develop a risk prediction webtool to communicate bowel cancer prognosis in a patient-focused manner2Flexible parametric survival modelling will be used to develop a prognostic survival model for bowel cancer. This allows for more accurate predictions by better capturing the underlying hazard function of the data in a more complex manner. Measures of relative survival, crude probability of death, cumulative incidence functions, and all-cause survival will be estimated across a range of time points. Conditional measures will also be used to demonstrate clinically relevant applications of the derived model. Predictor selection will combine clinical expert opinion and statistical selection methods.
Significant attention will be paid to handling informative missingness in electronic health records. In doing so, the developed model will provide novel predictive capacity which is more equitable for population subgroups which have more frequently systemic missing primary care data.
A risk communication tool will be developed using the model, aiming to improve public awareness of disease prognosis and encourage uptake of early detection interventions such as the national bowel cancer screening program.
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Prevalence of living alone in people with a neurodegenerative condition including dementia, Parkinson's disease, Huntington's disease and motor neurone disease — Laura Gamble ...
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Prevalence of living alone in people with a neurodegenerative condition including dementia, Parkinson's disease, Huntington's disease and motor neurone disease
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-24
Organisations:
Laura Gamble - Chief Investigator - Newcastle University
Laura Gamble - Corresponding Applicant - Newcastle University
Anthony Martyr - Collaborator - University of Exeter
Catherine Charlwood - Collaborator - University of Exeter
Claire Hulme - Collaborator - University of Exeter
Janet Oyebode - Collaborator - University Of Bradford
Linda Clare - Collaborator - University of Exeter
Maria Caulfield - Collaborator - University Of Bradford
Matthew Prina - Collaborator - Newcastle UniversityOutcomes:
- Annual prevalence of living alone in people with a neurodegenerative condition, including dementia, Parkinsonâs disease, Huntingtonâs disease and motor neurone disease (overall and by condition).
- Annual prevalence of living alone in people with a neurodegenerative condition stratified by measures of inequality.
- Change over time in prevalence of living alone in people with a neurodegenerative condition.Description: Lay Summary
Half of the people living alone in the UK are over the age of 65, and as family structures and living situations change the number of people living alone is increasing. We expect that the number of people living alone in the community with a progressive brain disease will also increase. These people are particularly vulnerable since they may have more problems accessing services and support. However, little is known about their needs.
In the UK, dementia is the most common progressive brain disease and affects almost 1 million people. As many as 20% of these people may live alone, and a recent report by Parkinsonâs UK found that almost 20% of people with Parkinsonâs disease live alone. We do not know anything about how many people with other progressive brain diseases, such as Huntingtonâs disease and motor neurone disease, live alone.
This study aims to estimate how many people with a progressive brain disease, including dementia, Parkinsonâs disease, Huntingtonâs disease and motor neurone disease, live alone in England using clinical records. We will explore differences by region, sex, marital status, ethnicity, deprivation, urban/rural location as well as change over time.
Alongside this work we will review what research has been done and consult with stakeholders to helps us better understand the needs of people living alone. We hope to gain insights into the challenges, coping mechanisms, diverse needs, and support systems of people living alone. This will allow recommendations for improvement in care and support services to be made.
Technical SummaryThe number of older people living alone in the UK is steadily increasing due to societal changes and shifts in lifestyle preferences. A concomitant increase in the number of people living alone in the community with a neurodegenerative condition, such as dementia, Parkinsonâs disease, Huntingtonâs disease and motor neurone disease, is expected. People living alone with these conditions are particularly vulnerable, often having inequitable access to services and support, and increased risk of adverse outcome.
The Alzheimerâs Society estimate that, of the 900,000 people living with dementia in the UK, 14% live alone, whereas another study recruited through memory services found that 18% lived alone. Parkinsonâs UK found almost 20% of people with Parkinsonâs disease lived alone. However, due to recruitment methods, estimates from research studies can vary widely and a population-based approach is needed for a more accurate estimate. Estimates for other neurodegenerative conditions are lacking.
The aim of this study is to use clinical records to estimate the prevalence of living alone with a neurodegenerative condition in England. Using CPRD and HES linked data, we will calculate the prevalence of people living alone on 1 January 2024. Analyses will be stratified by measures of inequality including region, sex, age, marital status, ethnicity, patient-level deprivation and practice-level urban/rural classification. Crude prevalence and prevalence standardised by age and sex will be reported, and logistic regression will be used to explore differences. We will investigate how prevalence of living alone has changed over the past 15 years using Joinpoint regression.
These analyses will be supported by a literature review, and stakeholder consultation and interviews with the aim of a better understanding of and response to the needs of those living alone with a neurodegenerative condition. Findings will help inform the development of policies and services tailored to meet their diverse needs.
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Evaluation of a Novel Composite Endpoint among Adolescents and Young Adults with Obesity in a Real-world Setting Using Clinical Practice Research Datalink Data: Feasibility Study. — Jennifer Davidson ...
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Evaluation of a Novel Composite Endpoint among Adolescents and Young Adults with Obesity in a Real-world Setting Using Clinical Practice Research Datalink Data: Feasibility Study.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Hai Nguyen - Corresponding Applicant - Evidera Ltd - UK
Jason Swindle - Collaborator - Evidera, Inc
Julie Beyrer - Collaborator - Eli Lilly & Co - US Headquarters
Kenneth Quinto - Collaborator - Eli Lilly & Co - US Headquarters
Rebecca Joseph - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
Sample size obtained from applying eligibility criteria; BMI distribution; BMI change; presence of prediabetes, hypertension, and hypertriglyceridemia; haemoglobin A1c (HbA1c), BP and triglyceride (TG) distribution; study sample baseline characteristics; length of follow-up in dataset; reason for end of follow-up (death, administrative censor, end of study period); complications of interest.
Description: Lay Summary
Obesity is increasing globally among people of all ages, including adolescents and young adults (AYAs). Health behaviour and lifestyle treatment may have limited benefits; drug therapy provides an alternative to help weight loss. Reduction of weight should also reduce obesity-related complications, e.g., diabetes and heart disease. However, many complications occur at older ages, so it is difficult determine the benefit of weight loss treatment on complications in AYAs.
Technical Summary
Improvement in body mass index (BMI), a measure of body fat based on height and weight, is often used as a short-term indicator of weight loss treatment benefit. High blood sugar, high blood pressure (BP) and high levels of fat in blood are also indicators of future diabetes and heart disease. Improvement in these conditions after weight loss treatment may also show its benefit.
This feasibility study will use primary care data from the CPRD Aurum dataset to determine if a suitable number of AYAs with obesity, who also have high blood sugar, high BP or high levels of fat in blood, are captured in the dataset. Among the AYAs, the number with complications such as diabetes and heart disease will be calculated. Results from this feasibility study will inform the design and methodology of a full study to evaluate whether change in BMI, blood sugar, BP or levels of fat in blood can predict future obesity-related complications; thereby, potentially shaping future obesity research, recognising which indicators of future diabetes and heart disease are most important to improve patient health and outcomes.The global prevalence of obesity in adolescents and young adults (AYAs) is a significant public health issue. The Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity recommends intensive health behaviour and lifestyle treatment (IHBLT) as the primary approach for managing obesity in children and adolescents. However, IHBLT alone has limited effectiveness in severe obesity cases. In addition to IHBLT, antiobesity medications (AOMs) may be considered following determination of treatment risks and benefits. However, the feasibility of prospective studies or trials to evaluate the effect of AOMs on long-term obesity-related complications is limited due to the low incidence of these complications at young ages, necessitating the need for long follow-up.
Change in BMI is often used as an indicator of treatment effect on weight, and therefore complication reduction. However, other methods of identifying change in cardiometabolic status may be beneficial for use in pharmacoepidemiologic research, such as change in prediabetes, hypertension, and hypertriglyceridemia. A composite endpoint based on the aforementioned cardiometabolic conditions was used in the SURMOUNT-1 clinical trial in adults. Trials using the composite endpoint in AYA are ongoing.
There is also a need to consider how this composite endpoint can be used in real-world studies. This feasibility study aims to determine if CPRD Aurum would be a suitable data source, in terms of sample size and length of follow-up, in which to conduct a retrospective observational study to evaluate a composite endpoint as a surrogate measure, in place of BMI, to predict future obesity-related complications among AYAs. We will apply eligibility criteria to obtain an estimated sample size for AYA with obesity, and summarise BP and blood-based laboratory test results and length of follow-up available for the sample. We will also estimate the numbers of clinical outcomes of interest observed in the dataset.
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Retrospective Cohort Database Analysis: Has the Prolonged Waiting Times for Elective Primary Total Hip or Knee Arthroplasty impacted the prevalence of Chronic Post-Surgical Pain and Opioid Consumption? — Lawrence Gillam ...
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Retrospective Cohort Database Analysis: Has the Prolonged Waiting Times for Elective Primary Total Hip or Knee Arthroplasty impacted the prevalence of Chronic Post-Surgical Pain and Opioid Consumption?
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
Lawrence Gillam - Chief Investigator - University of Nottingham
Lawrence Gillam - Corresponding Applicant - University of Nottingham
Brett Doleman - Collaborator - University of Nottingham
John Williams - Collaborator - University of Nottingham
Roger Knaggs - Collaborator - University of NottinghamOutcomes:
Our primary outcome measures of interest in this study:
-Chronic pain after hip or knee arthroplastySecondary outcomes of interest:
-Chronic postoperative opioid consumption in the 3 to 12 months following surgery. If an individual has 2 or more prescriptions from 90 â 365 days postoperatively they will be classed as having persistent opioid usage.
-Assess inequality by examining the distribution of waiting times by index of multiple deprivation and other socioeconomic factors.
-Prevalence of medical and mental health co-morbidity within the chronic pain after surgery cohort and in those without chronic pain after surgery.These outcome measures will then be used as part of a prediction model to see if those at greatest risk of developing or having persistent chronic pain after hip or knee arthroplasty can be more easily identified. More detail on the methodology is provided in the âexposure, outcomes and co-variatesâ section.
Description: Lay Summary
Hip and knee replacements are among the most common operations performed in the NHS, and primarily performed to improve pain, functionality, and quality of life. However, there is a proportion of people that continue to have or develop chronic pain following their operation. The proportion of people who report chronic pain after surgery is between 7-23% following a hip replacement, and 13 - 33% following a knee replacement.
The number of people waiting for a hip or knee replacement in England has continued to rise, with a significant increase in those waiting following the COVID-19 pandemic. In parallel with this, a significant number of people are now waiting over a year for a hip or knee replacement.
Prolonged waits for these types of major joint replacements negatively impacts a personâs ability to be active and their wellbeing. However, there is conflicting evidence about the effect of prolonged waiting times on the development of chronic pain following a hip or knee replacement. At present, evidence on whether people develop chronic pain following their operation is lacking when wait is over a year.
Given that one of the main reasons people have a joint replacement is pain, we aim to explore the effect of prolonged waiting times, prior to elective hip or knee replacement, on the development and/or persistence of chronic pain following a joint replacement.
We then plan to develop a predictive score to give a probability of those at greatest risk of chronic post-surgical pain following their joint replacement.
Technical SummaryPrimary hip and knee arthroplasties are among the most prevalent elective surgeries performed within the NHS. They are a cost-effective measure at primarily treating end-stage osteoarthritis as well as several other conditions. They are performed to treat the associated pain, functional decline, and reduced quality of life that people experience because of their condition. However, in this work we will focus on people with osteoarthritis of the effected joint.
It is well reported that a significant proportion of people develop chronic post-operative pain following major surgery. This has been reported to be between 7-23% following a hip replacement, and 13 - 33% following a knee replacement.
Following the COVID-19 pandemic waiting times for a hip or knee arthroplasty rose significantly, with more people now waiting over a year for their operation. Prior to the COVID-19 pandemic in 2018 there were 495 people waiting for over 52 weeks for a hip replacement and 1,255 waiting over a year for a knee replacement in England. In 2023, these figures were 10,155 and 15,065 respectively, for people that had completed their hospital episode.
Current evidence suggests that people waiting longer have a reduced âgainâ of function following their operation. Furthermore, the impact of prolonged waiting times on the development of chronic pain there is limited evidence for waits over one year. In this study we aim to utilise the CPRD database linked with HES-APC data to explore whether prolonged waiting times has impacted the development of chronic pain after surgery.
We then aim to construct and assess two predictive models: one, a logistic regression model and, two, a neural network approach. Our hope is that our analysis can help inform NHS trusts and policy makers and that models can be used in the pre-operative setting to better inform people prior to their surgery.
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Investigating the Risk of Muscle Problems in Patients Taking Statins — Zhenchen Wang ...
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Investigating the Risk of Muscle Problems in Patients Taking Statins
Datasets:GP data, CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-16
Organisations:
Zhenchen Wang - Chief Investigator - MHRA
Farah Francis - Corresponding Applicant - MHRA
Farah Francis - Collaborator - MHRA
Helen Booth - Collaborator - CPRD
Suniya Khatun - Collaborator - MHRAOutcomes:
We will be focusing on a multiple time-windowed diagnoses/measurements of myopathy as the primary outcome. The outcome will be categorized into two groups:
⢠(i) myopathy: patients with symptoms of myalgia or myositis or patients who discontinued their implicated statin with a rise in creatine kinase (CK) > 4 à upper limit of normal (ULN);
⢠and (ii) severe myopathy: individuals with a diagnosis of rhabdomyolysis or CK > 10 à ULN after statin exposure.
The upper normal creatine kinase is 320 IU/L for men and 200 IU/L for women.See Appendix B for code list.
Description: Lay Summary
Statin therapy is widely recognized for its success in reducing the risk of heart disease worldwide. However, some people who take statins may experience muscle-related side effects, a condition known as myopathy. Understanding how statins might cause muscle problems is important for doctors and patients to manage these side effects and improve overall patient care.
This study aims to better understand the link between taking statins and developing muscle problems. We will use advanced research methods to explore this relationship, with the goal of improving how we monitor and respond to side effects from medicines (a process known as pharmacovigilance). Specifically, we will:
1. Use data from the Clinical Practice Research Datalink (CPRD) to examine factors that increase the risk of muscle problems in people taking statins. This includes looking at how characteristics like age and other health conditions might affect the likelihood of developing muscle issues.
2. Develop a tool to predict which patient groups are most likely to experience muscle problems while taking statins. This tool will be created using CPRD data and tested thoroughly to ensure it is accurate and reliable for different groups of patients.
Technical SummaryStatin therapy is widely recognized for its effectiveness in reducing cardiovascular risk, yet the emergence of statin-induced myopathy presents a notable concern, affecting an estimated 1.5 million people per year. To address this issue, our study, focusing on adults aged 18 years and older, aims to pursue two primary objectives:
1. To identify and validate risk factors associated with myopathy in statin-users, exploring how various demographic and clinical factors collectively contribute to muscle issues when taking statins. This includes assessing the causal effects between statin use and myopathy, employing advanced causal inference techniques such as Targeted Maximum Likelihood Estimation (TMLE) and Double Machine Learning (DoubleML).
2. In addition, we aim to develop and validate an adverse drug reaction (ADR) prediction model for statin-induced myopathy using CPRD data. This model will leverage identified risk factors to predict the likelihood of developing myopathy.
Our approach involves developing treatment and outcome models, where the treatment model estimates how covariates influence the choice of statins, while the outcome model predicts the occurrence of myopathy based on statin types and various covariates. We will employ propensity score matching to balance covariates between treatment groups and instrumental variable analysis to address unmeasured confounding. Furthermore, sensitivity analyses, including Monte Carlo simulations, will assess the robustness of our findings to potential biases and unmeasured confounders.
Ultimately, our study aims to inform regulatory actions and communications, contributing to enhanced pharmacovigilance practices and patient safety in medicines. By addressing both the causal relationship between statin use and myopathy and developing an ADR prediction model, we hope to improve clinical decision-making and public health interventions in this critical area.
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Assessing inequalities in primary care and secondary care intervals for cancer among adults with learning disabilities and (or) severe mental illness in the England: a matched cohort study — Gabriele Price ...
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Assessing inequalities in primary care and secondary care intervals for cancer among adults with learning disabilities and (or) severe mental illness in the England: a matched cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
Gabriele Price - Chief Investigator - Office for Health Improvement and Disparities
Cam Lugton - Corresponding Applicant - Office for Health Improvement and Disparities
Anna Cox - Collaborator - University of Surrey
Katriina Whitaker - Collaborator - University of Surrey
Lanre Segilola - Collaborator - Office for Health Improvement and Disparities
Natalie Gil - Collaborator - University of Surrey
Robert Kerrison - Collaborator - University of Surrey
Tetyana Perchyk - Collaborator - University of SurreyOutcomes:
Primary Care Interval; Secondary Care Interval
Description: Lay Summary
Cancer is a leading cause of death in England. Compared with the general population, people with learning disabilities and people with severe mental illness (SMI) are up to two and a half times more likely to die from cancer before the age of 75. This may be due to delays in diagnosis, as more than half of cancers diagnosed in these populations are diagnosed at a late stage.
Evidence suggests that people with learning disabilities and/or SMI face additional barriers to accessing primary care, and that, when they do present, their symptoms are often misattributed by GPs, with symptoms wrongly attributed to the individualâs learning disability or SMI. This may mean they wait longer before being referred to see a specialist (this is known as the primary care interval). Evidence also suggests that these populations also face additional barriers to accessing secondary care. This may mean it also takes longer for them to receive a diagnosis (this is known as the secondary care interval).
This study aims to confirm whether there are significant differences in primary and secondary care intervals, between people with and without learning disabilities and/or SMI, and whether these differences explain why people with learning disabilities and/or SMI are typically diagnosed at a later stage. Determining this will enable clear recommendations to be put in place for GP and specialist consultations, with people with learning disabilities and SMI, and ultimately help reduce inequalities in early diagnosis and survival.
Technical SummaryBackground.
Cancer is a leading cause of death in England. For people with learning disabilities (LD) and/or severe mental illness (SMI), the risk of dying from cancer is higher than the general population. This may be due to diagnostic delays, as more than half of all cancers diagnosed in these populations are diagnosed at a late stage. Evidence suggests that for people with LD and/or SMI: additional barriers to accessing primary and secondary care are experienced; cancer symptoms are more likely to be misattributed due to âdiagnostic overshadowingâ; and âprimary care intervalâ and âsecondary care intervalâ are longer than for their peersPeople with LD are up to eleven times more likely to have SMI, compared to people without LD. It is possible that people with both conditions experience even longer intervals, than those with one or the other.
Methodology. To assess whether there are inequalities in primary care and secondary care intervals, between people with and without LD and/or SMI, for frequently diagnosed cancers, including cancers of the digestive organs (colon, rectum, anus, oesophagus), breast, lung, skin, lip, oral cavity, pharynx, and male & female genital organs), we will conduct a matched cohort study, using linked data from the following:
1. Clinical Practice Research Datalink
2. Cancer Registry
3. Hospital Episode Statistics
4. Index of Multiple DeprivationAnalysis: Descriptive statistics will be used to report the mean primary care and secondary care intervals for patients with and without a LD, with and without SMI and for patients with a LD and SMI. To determine whether any observed differences are statistically significant (for p values < 0.05), we will fit accelerated failure time models.
Secondary analyses will explore whether inequalities exist for individual cancers. We will also explore whether inequalities are more pronounced for individuals with a specific mental illnesses.
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Effects of ursodeoxycholic acid on the risk of Parkinson's: a cohort study — Li Wei ...
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Effects of ursodeoxycholic acid on the risk of Parkinson's: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-05
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Chengsheng Ju - Corresponding Applicant - University College London ( UCL )
Anette Schrag - Collaborator - University College London ( UCL )
Camille Carroll - Collaborator - Newcastle University
Kenneth Man - Collaborator - University College London ( UCL )
Thomas Foltynie - Collaborator - University College London ( UCL )Outcomes:
New-onset Parkinsonâs.
The diagnosis of Parkinsonâs in the database is defined as having one read diagnostic code for Parkinsonâs or at least one prescription of the anti-parkinsonian drugs (levodopa, dopamine receptor agonists, or monoamine-oxidase-B inhibitors).We will also explore the risk of prodromal presentations of Parkinson's including neuropsychiatric disturbances (depression, anxiety, and insomnia) and autonomic symptoms (constipation, urinary dysfunction, hypotension, and dizziness), using code lists provided in previous publication (10.1016/S1474-4422(14)70287-X).
Description: Lay Summary
Parkinsonâs is a brain disorder causing difficulty in movement. There is no cure to Parkinsonâs yet.
Technical Summary
Ursodeoxycholic acid (UDCA) is a commonly used medication for liver related diseases. There are preclinical data to suggest the drugs may be used to slow down the progression of Parkinsonâs, but we need more data from humans to confirm their effects. In this study, we wish to find out whether the use of UDCA is helpful for individuals to prevent Parkinsonâs in the real world. The best way to confirm the effect of a drug is to conduct randomised controlled trials. However, these trials are extremely expensive and time-consuming. As a solution, we will design randomised controlled trials and emulate these trials using readily available observational electronic healthcare data. We will compare UDCA drug with no UDCA drug in patients with liver disease to find out whether the drug can prevent Parkinsonâs. This study will provide valuable evidence to support the explorations of new therapies for treating Parkinsonâs.Parkinsonâs is a progressive neurological condition with no disease-modifying treatment available. Mitochondrial dysfunction is one of the key characteristics in Parkinsonâs.
Ursodeoxycholic acid (UDCA) is commonly used drugs for multiple liver, biliary tract, or gallbladder disorders that requires a long-term administration. Several preclinical studies have consistently shown that UDCA is a promising drug candidate to rescue mitochondrial function in patients at risk of Parkinsonâs. UDCA has been a prioritised neuroprotective agent for Parkinsonâs. Safety and effectiveness of UDCA in early Parkinsonâs has been investigated in the previous UP trial but it was limited by the study power and generalisability. There is no other clinical study evaluating UDCA for Parkinsonâs.
In this study, we will evaluate the effect of UDCA on prevention of Parkinsonâs using real-world observational data.
We will use the CPRD database from 1990 to 2021. We will emulate target pragmatic trials comparing UDCA treatment versus no treatment on the risk of new-onset Parkinsonâs. We will include patients aged 45 to 84 years between 1990 to 2021, without prior Parkinsonâs, dementia, or levodopa treatment. We will use a sequential nest trial emulation approach, thereby, we will emulate multiple trials starting at different ages (from 45 to 84 years). In total, 160 trials will be emulated. Patients will be categorised according to comparable treatment strategies during the baseline year, and all patients will be followed from the start of that trial until outcomes (incident Parkinsonâs) or loss-to-follow-up. The study outcome will be a diagnosis of new-onset Parkinsonâs. UDCA treated patients will be rolling matched to non-treated patients at 1:2 ratio based on propensity score within each trial. Propensity scores will be estimated using logistic regression. We will estimate both observational analogues of the intention-to-treat effect and per-protocol effect. Pooled logistic regression will be used to estimate treatment effect.
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The association between use of tricyclic antidepressants or selective serotonin reuptake inhibitors and urinary tract infection among people with multiple sclerosis: a nested case-control study — Marloes Bazelier ...
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The association between use of tricyclic antidepressants or selective serotonin reuptake inhibitors and urinary tract infection among people with multiple sclerosis: a nested case-control study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-23
Organisations:
Marloes Bazelier - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Bernard Uitdehaag - Collaborator - VU Medical Centre
Ewoudt van de Garde - Collaborator - Utrecht University
Melissa Leung - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht UniversityOutcomes:
Urinary tract infection for which an antibiotic was prescribed or hospitalization took place
Description: Lay Summary
Multiple sclerosis (MS) is a disease in which the patientâs own immune system disturbs message transmission in the brain and spinal cord. This can cause various symptoms, including pain and depression. People with MS who experience pain, depression, or both may be prescribed antidepressant medications by their doctor. These antidepressants can be âtricyclic antidepressantsâ (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or âselective serotonin reuptake inhibitorsâ (SSRIs). TCAs and SNRIs, because of how they work, might increase the risk of urinary tract infection (UTI). It is already known that people with MS experience a high burden of UTI. The purpose of this study is to investigate whether people with MS who use a TCA or SNRI are at a higher risk of experiencing UTI than people with MS who use an SSRI. The potential importance of the findings is that they may help inform the treatment decision if UTI is a particular concern for a person with MS who experiences depression, pain or both.
Technical SummaryMultiple sclerosis (MS) is a chronic demyelinating disease that may cause various symptoms, including neuropathic pain and depression. Both neuropathic pain and depression in MS may be treated with antidepressants, mainly tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and selective serotonin reuptake inhibitors (SSRIs). TCAs and SNRIs may increase the risk of urinary tract infection (UTI): TCAs through their anticholinergic action and SNRIs because they cause the urinary sphincter to contract and the detrusor to relax. UTI places a known high burden on people with MS. The aim is to investigate whether use of TCAs and SNRIs is associated with the risk of UTI among people with MS, compared to use of SSRIs. A dynamic cohort of people with MS (who are at least 18 years old and no history of malignancy at the moment of recorded diagnosis) will be constructed based on a GP record of a first MS diagnosis between January 2000 up until April 2024 in CPRD Aurum. From this cohort, cases will be selected for this case-control study by selecting those people with at least one antibiotic prescription for UTI after the first MS diagnosis. Controls will be selected by density-based sampling. We will perform a conditional logistic regression analysis on the exposure to TCA or SSNRI versus SSRI during the occurrence of the first UTI after the MS diagnosis. Strengths of this study are the efficiency by the case-control design and the sensitivity and specificity in outcome ascertainment. The intended public health benefit is that the findings may inform the benefit-risk ratio of antidepressant in the treatment of people with MS and prevent additional burden of UTI as an adverse event in this susceptible population
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Retrospective Cohort Study on English Patients with Inflammatory Bowel Disease with Uncontrolled Disease Activity — Jennifer Davidson ...
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Retrospective Cohort Study on English Patients with Inflammatory Bowel Disease with Uncontrolled Disease Activity
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-13
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Sophie Graham - Corresponding Applicant - Evidera, Inc
Achim Wolf - Collaborator - Evidera Ltd - UK
Alun Passey - Collaborator - Janssen Pharmaceuticals UK
Andre Ng - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Khalid Siddiqui - Collaborator - Janssen-Cilag Ltd
Rebecca Joseph - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Robert Donaldson - Collaborator - Evidera Ltd - UKOutcomes:
The outcomes to be measured are relapse; remission and switch to next advanced therapy.
Description: Lay Summary
Inflammatory bowel disease (IBD) is a term used to describe conditions that cause severe stomach ache and diarrhoea. It is estimated that one in every 123 persons in the UK suffers from IBD. The main types of IBD are Crohnâs disease (CD) and ulcerative colitis (UC). Patients with IBD can experience symptoms that range from mild cramps and diarrhoea to severe abdominal pain or bowel obstruction. These painful episodes can have a very negative impact on a patientâs everyday life. Advanced therapies may be required to bring the disease under control and to keep it stable for long periods of time. In some cases therapies may not alleviate the disease in the expected time frame, or may bring the disease to a level that is not fully under control. In these instances, the patient may benefit from switching to a different therapy that can better manage their condition.
Technical Summary
The aim of this study is to determine the number of patients with IBD receiving therapies in England using anonymised primary and secondary care data, and to assess the proportion of these patients that continue to demonstrate signs of insufficient disease control despite treatment. We will describe characteristics of these patients, such as age, gender and treatments received. IBD poses an increasing health and cost burden in the UK, which has one of the highest proportions of patients in its population compared to other countries. By quantifying and describing patients with unmanaged disease this will help care to be targeted towards them.Inflammatory bowel disease (IBD) is characterised by chronic and progressive inflammation of the gastrointestinal (GI) tract. IBD poses an increasing burden in the UK, which has one of the highest prevalences of IBD in the world. Patients with IBD experience periods of uncontrolled disease activity which include inflammation of the gastro-intestinal tract leading to mild to severe abdominal pain and/or changes to bowel movements. The primary goal of treatment is to control disease activity, and to maintain remission. A number of advanced therapies are approved for treatment such as antibodies against tumour necrosis factors (TNF), α4β7 integrins, interleukin-12/23 (IL-12/23), and small molecular inhibitors targeting Janus kinases (JAKs) and S1P receptor modulators (S1Ps).
The primary aim of the study is to investigate the population size and define the characteristics of patients with IBD with uncontrolled disease activity despite receiving advanced therapies. The study is designed to address three specific objectives amongst patients initiating an advanced therapy:
1. To describe patient characteristics such as age, sex, time to diagnosis, length of follow-up, and comorbidities.
2. To describe disease-specific characteristics, including biomarker tests, the number of previous therapies, procedures, and where available describe clinical index scores.
3. To describe the number and proportion of patients who achieve remission, experience relapse, or require a switch in therapy within one year of first advanced therapy.
The study will utilise the CPRD Aurum linked to Hospital Episode Statistics to investigate the population size and characteristics of patients receiving advanced therapies and to describe their disease activity. The study design is a cohort study, and the main statistical analyses will be descriptive in nature, focusing on proportions and numbers to describe the outcomes of interest.
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Population-based cohort study on the utilisation, adherence, discontinuation, switching, and restarting of treatments and medications of regulatory interest — Daniel Prieto...
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Population-based cohort study on the utilisation, adherence, discontinuation, switching, and restarting of treatments and medications of regulatory interest
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-03
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Xintong Li - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
- Population-level incidence and prevalence
- Medication utilisation will be assessed in terms of indication of use, duration, strength and/or dose.
- Treatment pattern including adherence, discontinuation, switching, add-on, and re-starting of the medication.
- Summary characteristics (demographics, comorbidity, co-medication) of user of medication or treatment of regulatory interest.Description: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources across Europe. The EMA will request several studies with the same study design to assess how treatments and medicines are utilised in both the general population and among people with specific conditions.
Technical Summary
In this study, we will first estimate how frequently people start a new medicine, and how many existing users are among the population of interest. Secondly, we will look at the indications or reasons for these medicines, and how long and at what strength they are prescribed. We will explore the sequence of treatment which includes whether people were adherent to the medication, change to other medications, or stop using the treatment. We will also explore characteristics of patients prescribed/dispensed the drugs in terms of comorbidity and concomitant drug use. All these will be calculated in specific populations of interest based on age group, sex groups, and clinical characteristics, and over calendar years to look at possible changes over time.
The results of this study will provide regulators insight into the uptake of specific drugs in the community and whether the use of these drugs changes over time influenced by regulatory measures such as drug shortage, change in labeling, safety warnings, etc.Primary care records provide a unique source of data for estimating the incidence and prevalence of medication use in the community, as most medicines are prescribed by general practitioners. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the uptake of specific drugs of interest and to study the effect of regulatory actions on drug prescribing/dispensing, EMA will commission several drug utilisation studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: The general population, or people with specific demographic or clinical characteristics as requested by the EMA. Exclusion criteria may apply according to the study objective (including history of specific conditions and minimum follow-up time).
Exposures: medication or treatment exposure based on prescription data as available within CPRD GOLD or CPRD Aurum.
Outcomes: incident and prevalent use of medication; drug utilisation including indication, dose, and duration; and adherence and/or change of treatment.
Other covariates:
- Age
- Sex
- Calendar period/Time windows (to monitor changes over time)
- Other subgroups (such as specific disease sub-types and/or treatment regimen types)
- Patient specific characteristics in terms of comorbidity and use of concomitant medication at the time of interest.
Analysis:
Incidence rates and prevalence stratified by age, sex, calendar time, and other subgroups. Description of patient characteristics at therapy initiation, and use of medicine/s over time. Medication utilisation will be assessed in terms of indication of use, duration, strength and/or dose. Adherence, discontinuation, switching, add-on, and re-starting of the medication will be assessed.
Additional medicines will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
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Treatment patterns, clinical outcomes and healthcare resource use in glycaemic therapy-using patients with Type 1 or 2 diabetes: a retrospective cohort analysis — Craig Currie ...
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Treatment patterns, clinical outcomes and healthcare resource use in glycaemic therapy-using patients with Type 1 or 2 diabetes: a retrospective cohort analysis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-06
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Bethany Levick - Corresponding Applicant - Harvey Walsh Ltd
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Chris Chesters - Collaborator - Abbott Diabetes Care Limited
Emily Wilkes - Collaborator - OPEN Health Group
John Robinson - Collaborator - Harvey Walsh Ltd
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Shea O'Connell - Collaborator - OPEN Health Group
Stephen Boult - Collaborator - Harvey Walsh LtdOutcomes:
Total number of patients receiving each GT of interest (insulin, GLP-1, SGLT-2, sulfonylureas, other GTs); insulin modality in patients prescribed insulin (basal, premix, MDI); total number of patients with a prescription for a CGM; total patients receiving each GT of interest in the therapies prescribed prior to index; total patients receiving each GT of interest in the therapies prescribed prior to switch to insulin pre-mix; duration of diabetes at index distribution; age at index distribution; HbA1C control level distribution; IMD quintile distribution; charlson co-morbidity index distribution; Sex distribution; Summary (Mean, S.D., Median, 1st and 3rd quartile) of clinical measures (creatinine, cholesterol, albumin, blood pressure, weight, BMI) nearest to index; total number of non-GT prescription distribution; total number of comorbidities diagnosed in follow up distribution; diabetes related clinical outcomes and healthcare resource use (HCRU) (Foot ulcers or infections; Kidney-related issues or diabetic nephropathy, Microvascular events, Macrovascular events, Intensive care unit (ICU) admissions related to DKA or Severe hypoglycaemia or hyperosmolar hyperglycaemic state (HHS)); total number of primary care HCRU events during follow up (Primary care consultations, Primary care prescriptions, Primary care laboratory tests/measurements); total number of secondary care HCRU events during follow up (Inpatient admissions, Length of inpatient stay, Outpatient attendance, Accident and Emergency (A&E) visits); summary (Mean, S.D., Median, 1st and 3rd quartile) of total all-cause primary care costs (£); summary (Mean, S.D., Median, 1st and 3rd quartile) of total all-cause secondary care costs (£);summary (Mean, S.D., Median, 1st and 3rd quartile) of total care costs relating to diabetes (£);Total number of patients with hospital admission with a recorded primary diagnosis of diabetic ketoacidosis (DKA); Total number of patients with hospital admission with a recorded primary diagnosis of severe hypoglycaemia; Total number of patients with hospital admission with a recorded primary diagnosis of diabetic coma; Total number of patients with hospital admission with a recorded primary diagnosis of HHS; Total number of patients with a hospital admission with a recorded primary diagnosis of any of severe hypoglycaemia, diabetic coma, DKA or HHS; total number of patients observed to have died by the end of follow up; total number of patients observed to have died due to cardiovascular causes by the end of follow up; total number of patients observed to have experienced a cardiovascular event by the end of follow up; Summary (Mean, S.D., Median, 1st and 3rd quartile) of historic exposure to elevated (>7.5%) HbA1C; distribution of patient ethnicity; distribution of geographical region; total patients with a diagnosis of a severe mental illness prior to index
Description: Lay Summary
Diabetes affects over 3 million people in the UK. Type 1 (T1DM) and type 2 diabetes (T2DM) are the most common forms of diabetes. People with T1DM cannot produce the substance insulin to manage how much sugar is in their blood. People with T2DM produce insulin but still have too much sugar in their blood, so are prescribed medicines to help.
This study aims to describe what medicines are prescribed to patients with T2DM in the UK, the characteristics of patients receiving each medicine, and how much care they medical care they receive over a year.
The study also aims to describe how many people with T2DM have been prescribed a new type of device to help monitor their blood sugar.
Understanding how diabetic medicines and new technology are prescribed in the UK is of public health benefit as it may highlight groups of patients prescribed newer medicines or devices less often or unmet patient need.
The study will also describe how often patients with T1DM or T2DM become very ill because their blood sugar was very high or very low, and test if people who experience this are more or less likely to have heart disease or die earlier than people who do not. This evidence will help understand the burden of diabetes on affected people and highlight areas of improvement in diabetes management.
To answer these objectives, the study will use the Clinical Practice Research Datalink, linked to Hospital Episode Statistics and the Office for National Statistics databases.
Technical SummaryThe prevalence of both Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM) has risen in England since 2017. In 2022 diabetes medicines cost the NHS £1.53 billion (NHS Business Services Authority, 2022).
Given this high cost to the NHS, up-to-date descriptions of the use of medicines such as pharmacological glycaemic therapies (GTs) and continuous glucose monitors (CGMs) in the DM population are important for care planning. Moreover, descriptions of the patient groups prescribed GTs and CGMs, and their healthcare resource utilisation (HCRU) and outcomes, can demonstrate areas of inequity in access to therapies and quantify the benefits of different treatment options.
The study will include patients in the Clinical Practice Research Datalink (CPRD) database with a diagnosis of T1DM or T2DM who have GT prescriptions reported in CPRD. The analysis will be conducted in two (overlapping) cohorts:
Population 1: patients with T2DM prescribed GTs, or CGMs,
Population 2: patients with T1/2DM, who are prescribed insulin or GTs.This study will describe outcomes including glycaemic therapy use, treatment patterns (CPRD), clinical and HCRU outcomes (CPRD/Hospital Episode Statistics (HES))including acute diabetes events (ADEs) (HES) and future cardiovascular (CV) events and mortality in patients with diabetes (DM) (Office of National Statistics, (ONS)).
Population 1
Aim 1 is to describe the clinical profile and HCRU of patients in Population 1 (T2DM) who are in receipt of GTs ( in England.
Aim 2 is to describe CGM prescribing for the management of T2DM and describe the groups who have impacted HbA1C control following CGM prescription.Population 2
Aim 1 is to describe the burden of hospital admission for diabetic ketoacidosis (DKA) in England.
Exploratory Aims to describe the clinical burden of acute events related to diabetes, test the associations between ADEs/historic exposure to excess HbA1c with future CV events/mortality using Cox regression.
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Quantifying the burden of disease associated with perimenopause using data held within United Kingdom Primary Care electronic health records (EHRs) — Yvette Pyne ...
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Quantifying the burden of disease associated with perimenopause using data held within United Kingdom Primary Care electronic health records (EHRs)
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-26
Organisations:
Yvette Pyne - Chief Investigator - University of Bristol
Yvette Pyne - Corresponding Applicant - University of Bristol
Abigail Fraser - Collaborator - University of Bristol
Brendan Delaney - Collaborator - Imperial College London
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence of perimenopause based on frank diagnosis measures; prevalence of perimenopause based on proxy measure of prescriptions of hormone replacement therapy; prevalence of perimenopause based on proxy measure of symptoms; prevalence of a selected group of differential diagnoses that are clinically similar to symptoms of perimenopause (including change in menstrual cycle, vasomotor symptoms such as hot flushes, new mental health issues such as anxiety or depression, new cognitive issues such as âbrain fogâ, new muscle or joint pains, or new genitourinary symptoms such as recurrent UTIs); primary care contacts; primary care prescriptions; primary care costs; primary care prescription costs.
Description: Lay Summary
Menopause is the point in a womanâs life when her periods stop; this typically happens around the age of 51 but it can happen much earlier for a small number of women. Perimenopause is defined as the time around the menopause when a person might experience symptoms such as hot flushes, âbrain fogâ, mood swings, feeling tired, aches and pains, or symptoms like repeated urinary tract infections (UTIs). Due to a combination of there being so many different symptoms and there not being a test that doctors can use to diagnose perimenopause, it can be difficult for them to tell if someone is experiencing it. Women might be being diagnosed with other conditions incorrectly such as anxiety and depression, or Long Covid. It also means that we do not know how many people experience perimenopause.
We plan to use the Clinical Practice Research Datalink database which contains an anonymised proportion of GP records to work out how many people have been diagnosed with perimenopause, how many people have been started on treatment for perimenopause, and how many people might have perimenopause based on the symptoms that they have. We plan to see how much these people are using NHS resources such as GP appointments and medications. This will be useful to doctors who need to diagnose perimenopause, researchers hoping to research it, and those who allocate NHS resources to understand how common perimenopause it is and how much money it costs when people are or are not diagnosed with it.
Technical SummaryPerimenopause is the time around menopause (often many years) that may be associated with a range of symptoms including vasomotor symptoms, cognitive impairment, mood changes, fatigue, urogenital symptoms, and low libido. The breadth of these symptoms, their often extended chronological incidence, and the lack of a gold standard diagnostic test means that precise prevalence rates are not known. This study aims to describe the prevalence of perimenopause and to estimate resource utilisation and costs associated with the condition. This will be achieved by considering four groups of people (three cohorts and one control group) who have differing likelihood of a diagnosis of perimenopause.
The study will be conducted in the Clinical Practice Research Datalink (CPRD) dataset linked to the Office of National Statistics Index of Multiple Deprivation dataset. Three cohorts of patients of acceptable research quality will be selected from CPRD AURUM and CPRD Gold datasets included by:
1) frank diagnosis,
2) proxy diagnosis based on prescription history,
3) proxy diagnosis based on an algorithm related to presenting symptoms.Point prevalence will be calculated for each group from 2004-2021. Patients will be matched by primary care practice, age, gender and current practice registration to controls without a frank or proxy diagnosis. Primary care contacts and medication prescriptions will be costed using standard NHS tariffs. Rates will be compared between groups and with non-exposed controls using Poisson distribution and associated costs will be compared using the Gamma distribution. Prevalence rates by each method will be compared by ethnicity and indices of material deprivation. For those patients selected by the proxy of symptom combinations, alternate diagnoses in their patient history will be summarised. This study will provide valuable data to inform clinical practice and healthcare decision making.
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Methodological Approaches to Minimizing Immeasurable Time Bias in Oral Anticoagulant Use and the Risks of All-cause Mortality, Recurrent Stroke, and Major Bleeding Among Patients with Ischemic Stroke — Samy Suissa ...
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Methodological Approaches to Minimizing Immeasurable Time Bias in Oral Anticoagulant Use and the Risks of All-cause Mortality, Recurrent Stroke, and Major Bleeding Among Patients with Ischemic Stroke
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-02
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
In-Sun Oh - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
⢠All-cause mortality
⢠Recurrent stroke
⢠Major bleedingDescription: Lay Summary
Pharmacoepidemiologic studies involve using large healthcare databases to assess and evaluate the effects of medications on clinical outcomes. However, most of the healthcare databases used in pharmacoepidemiologic research do not record in-hospital medication information. This systematically missing information can result in important bias that distorts the estimated treatment effects, called "immeasurable-time bias (IMTB)." This bias is most likely to occur in settings involving prolonged periods of hospitalization prior to the event of interest and when the comparator group is unexposed (i.e., not using a drug). To date, one study has explored methodological approaches to reduce IMTB. However, this previous work was restricted to a single case study involving beta-blocker (a class of drugs used slow heart rate) use and all-cause mortality among patients with heart failure using administrative healthcare data from Korea. The generalizability of these findings across different populations, regions, and data sources remains unclear. We aim to examine different methodological approaches to reduce the magnitude of IMTB in a clinical case of oral anticoagulant (blood thinning drug) use and the risks of all-cause mortality, recurrent stroke, and major bleeding among patients with ischemic stroke (stroke caused by blockages in the brain) using data from the Clinical Practice Research Datalink Aurum linked to hospitalization and vital statistics data. Similar analyses will be conducted using data from Korea. The findings of this study will add to understanding of the bias and validity of proposed solutions and contribute to improving the accuracy of pharmacoepidemiologic studies.
Technical SummaryMost administrative databases used in pharmacoepidemiologic research do not include data regarding in-hospital drug use, which can lead to the misclassification of exposed patients as unexposed, resulting in immeasurable time bias (IMTB). This bias is particularly relevant in the study of chronic diseases that often result in extended periods of hospitalization before the outcome of interest. Although a study has examined this issue, it is necessary to assess the generalizability of its findings across different populations, regions, and data sources. Our objective is to evaluate the magnitude of IMTB and examine the effectiveness of proposed methodological approaches to address it in the context of oral anticoagulant use and all-cause mortality, recurrent stroke, and major bleeding among patients with ischemic stroke.
To achieve this, we will conduct a population-based cohort study using the CPRD Aurum and linked databases. The study population will consist of patients with ischemic stroke aged 18 years or older between January 1, 2012, and March 31, 2023. Cohort entry will be defined by the date of diagnosis of ischemic stroke in the CPRD. We will classify each person-day of the follow-up period as exposed to direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA) or as unexposed. Outcomes of interest include all-cause mortality, recurrent stroke, and major bleeding.
We will estimate the hazard ratio for the association between current use of DOAC or VKA, compared with no use of either, using a Cox proportional hazards model. We will then apply the "adjustment for time-varying hospitalization" approach that was shown to effectively reduce the immeasurable time bias in a prior study. Finally, we will compare the results of our proposed methodological approaches with those of meta-analyses to ensure their effectiveness in reducing IMTB. Analyses will be repeated using population-based data from Korea.
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The Impact of Estradiol + Dydrogesterone on Menopause Oestrogen Deficiency Symptoms Treatment — Anne Broe ...
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The Impact of Estradiol + Dydrogesterone on Menopause Oestrogen Deficiency Symptoms Treatment
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-05
Organisations:
Anne Broe - Chief Investigator - IQVIA Ltd ( UK )
Sophia Fleming - Corresponding Applicant - IQVIA Ltd ( UK )
Emma Rezel-Potts - Collaborator - IQVIA Ltd ( UK )
Julia Gallinaro - Collaborator - IQVIA Ltd ( UK )
Sarah Lay-Flurrie - Collaborator - IQVIA Ltd ( UK )
Simeon Stavrev - Collaborator - IQVIA Solution Bulgaria EOOD
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Vishalie Shah - Collaborator - IQVIA Ltd ( UK )Outcomes:
⢠Variables to define the study population: Prescription of HRT, ovarian deficiency diagnosis, diagnosis of menopause, diagnosis of early menopause, diagnosis of primary ovarian insufficiency (POI), previous hysterectomy.
⢠Availability and completeness in CPRD: Last Menstrual Period prior to HRT initiation (within 0-6months, 6-12months, 12+months), assessment of HRT prescriptions by types of treatment (Estrogen only, any estrogen and progesterone combination overall and by individual combinations, fixed and free dose combinations, Tibolone), assessment of data to inform timing and duration of treatment in full study, assessment of HRT administration routes, dosage and mode of use.Description: Lay Summary
Oestrogen is a hormone that regulates the female reproductive system. Women who have low levels on oestrogen may have symptoms like hot flushes, night sweats, mood changes and bone loss. It can also cause other changes in the body that increase the chances of developing cardiovascular disease and cancer. Hormone replacement therapy (HRT) is often used to reduce these symptoms. Patients receiving HRT may be given oestrogen hormones alone or oestrogen and progesterone hormones together (combined HRT). The choice of HRT depends on symptoms, patient preferences, age, and other medications the patient may be taking. How well HRT works and how safe it is can vary depending on a patientâs body mass index, the medical conditions they have and menopausal symptoms. The type of HRT, duration of treatment, dose and when treatment is started can also be important. It is important that to have the most up-to-date update, population-based evidence on HRT that can provide greater understanding of the complexity of the relationship between HRT and conditions including cardiovascular disease and cancer. There is a need for further, up-to-date, real-world evidence (RWE) on HRT and its risks so that those experiencing symptoms associated with ovarian deficiency/menopause and the clinicians treating them can be well-informed in their choice of safe and effective treatment. The aim of this feasibility study is to assess the size of the study population of interest within CPRD and to assess availability of information related to clinical characteristics, medical conditions, and HRT prescriptions.
Technical SummaryThis feasibility study aims to understand the availability and completeness of data relating to ovarian deficiency and HRT treatments in the adult population of England from 01 January 2010 to 31 March 2021.
The objectives are as follows:
1. To determine the total study population following the inclusion and exclusion criteria, including number of women treated with HRT among women diagnosed with ovarian deficiency.
2. To assess the type of ovarian deficiency, age at treatment initiation, and duration of available follow-up from treatment initiation, among women treated with HRT
3. To assess Last Menstrual Period (LMP) recording prior to initiation of HRT
4. Assessment of HRT prescriptions, including types of treatment.
5. Assessment of data to inform timing and duration of treatment in full study including availability of HRT prescriptions.
This will be a retrospective cohort study using CPRD, the overall study population will include adult women with a diagnosis of ovarian deficiency, and/or treatment with HRT during the study period. Descriptive analyses will be conducted using number and percent with mean, median, and other summary statistics for continuous variables. No imputation methods will be used. Findings will inform the full study, which aims to provide up to date, real-world evidence on HRTs and associate risks which may inform clinical practice within the UK.
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Analysis of the Clinical Practice Research Datalink (CPRD Gold + Aurum) and Hospital Episode Statistics (HES) on the recurrence of uncomplicated urinary tract infection (UTI) among women with a recent history of UTI: a retrospective observational study — Rosa Sloot ...
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Analysis of the Clinical Practice Research Datalink (CPRD Gold + Aurum) and Hospital Episode Statistics (HES) on the recurrence of uncomplicated urinary tract infection (UTI) among women with a recent history of UTI: a retrospective observational study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
Rosa Sloot - Chief Investigator - GlaxoSmithKline Services Unlimited (UK)
Rosa Sloot - Corresponding Applicant - GlaxoSmithKline Services Unlimited (UK)
Iain Gillespie - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Nicola Williams - Collaborator - GlaxoSmithKline Services Unlimited (UK)
Urvee Karsanji - Collaborator - GlaxoSmithKline Services Unlimited (UK)Outcomes:
- Objective 1 and 2: the rate of UTI episode recurrences during 6- and 12-month follow-up
- Objective 3 and 4: the probability of remaining UTI-free during 6- and 12-month follow-up
- Objective 5: similar to Objectives 1-4Description: Lay Summary
Urinary tract infections (UTIs) are among the most common type of bacterial infections in primary care, affecting 150 million people each year worldwide, and they are especially common among women.
Technical Summary
Although it is well known that the risk of subsequent UTI after an initial UTI differs depending on age and number of previous UTIs, this relationship has not been studied very well. Understanding which women are at a higher risk for subsequent UTIs is crucial for targeting preventative strategies effectively, ensuring those who are most vulnerable receive the necessary healthcare in England.
Using the Clinical Practice Research Datalink (CPRD) we plan to conduct a cohort study which aims to assess risk factors of UTI among women 12 years and older with a history of recurrent UTI.Uncomplicated urinary tract infection (uUTI) is one of the most common infections seen in primary care among women. Approximately 11% of women experience an episode of uUTI per year, and in England it has been estimated that women have a 3% annual prevalence of recurrent UTI.
Although having a history of previous UTI is a known risk factor for future UTI risk, the exact relationship between frequency of previous UTI episodes and risk of subsequent UTI recurrences is unknown. This study aims to increase the understanding of this relationship and other factors, including age, driving the differential risk of UTI recurrence among women with a recent history of recurrent UTI.
The study will use retrospective data analyses among adult and adolescent female patients with linkable Clinical Practice Research Datalink (CPRD)/ Hospital Episode Statistics (HES) data in the period January 1, 2017, through December 31, 2023. The study will identify a cohort of women 12 years and older with recurrent uncomplicated UTI and follow them over a 12-month period to assess the rate of UTI episode recurrences and identify which factors drive this rate. Specifically, this study aims to (1) use negative binominal regression to estimate the UTI recurrence rate and to identify key predictors driving this rate, (2) estimate the cumulative probability of remaining UTI-free and assess which factors impact UTI-free time using Cox regression models, and finally (3) assess how these outcomes differ in various age groups.
Insights from this study will help to identify women at increased risk for recurrent UTI and thereby guide future preventative strategies as well as contribute to a better understanding of the wider burden of recurrent uUTI among women in England.
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Comparative effectiveness of triple therapy with Bisoprolol, Perindopril, Amlodipine, versus dual therapy in hypertensive patients: an observational retrospective cohort study — CELINE DARRICARRERE ...
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Comparative effectiveness of triple therapy with Bisoprolol, Perindopril, Amlodipine, versus dual therapy in hypertensive patients: an observational retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
CELINE DARRICARRERE - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Pablo Suárez Sánchez - Corresponding Applicant - OXON Epidemiology - Spain
Alessandra Lacetera - Collaborator - OXON Epidemiology - Spain
Alfonso SARTORIUS - Collaborator - IRIS - Institut de Recherches Internationales Servier
Alice Baccino - Collaborator - OXON Epidemiology - Spain
Bélène Podmore - Collaborator - OXON Epidemiology - Spain
Caroline APERT-MAAREK - Collaborator - IRIS - Institut de Recherches Internationales Servier
Claudia Rey Carrascosa - Collaborator - OXON Epidemiology - UK
Cono Ariti - Collaborator - OXON Epidemiology - Spain
Ernesto Garcia - Collaborator - OXON Epidemiology - Spain
Julia Agúndez - Collaborator - OXON Epidemiology - Spain
Khaoula Aroui - Collaborator - IRIS - Institut de Recherches Internationales Servier
Raquel López González - Collaborator - OXON Epidemiology - UK
Sophie Birot - Collaborator - IRIS - Institut de Recherches Internationales ServierOutcomes:
Primary outcomes: Difference in systolic blood pressure change at 8 weeks.
Secondary outcomes: Difference in diastolic blood pressure change at 8 weeks; blood pressure control at 8 weeks; change in treatment; duration of treatment; adherence to treatment; persistence to treatment; incidence rate of adverse events; health resource use (number of hospitalizations, duration of hospitalization, emergency room visits); incidence rate of cardiovascular events including myocardial infarction, stroke, cardiovascular death heart failure and acute renal failure.
Description: Lay Summary
High blood pressure, also known as hypertension, is a common condition that significantly increases the risk of serious health problems, including heart disease, stroke, and kidney damage. If not properly managed, these complications can lead to severe outcomes, such as heart attacks and even death. To help lower blood pressure, doctors typically prescribe various types of medications.
This study focuses on three specific medications used to treat hypertension: perindopril, amlodipine, and bisoprolol. The goal is to determine whether patients whose blood pressure remains uncontrolled with two of these medications achieve better results by adding the third medication, compared to those who continue with only two medications.
By analysing existing health records, the study aims to provide important insights that can help doctors improve how high blood pressure is treated. Understanding how these medications work together in real-life situations will help ensure that treatment plans are both effective and safe. Better controlling blood pressure could lead to a reduction in serious heart and blood vessel diseases, ultimately benefiting public health.
Technical SummaryThis study aims to determine the effectiveness on blood pressure reduction of the triple combination of Perindopril+ Amlodipine+ Bisoprolol (used concomitantly as combination), compared to the respective dual therapy components in real life conditions.
Adult hypertensive patients on two-drug combination therapy (two drugs among Perindopril, Amlodipine and Bisoprolol) and who are not controlled by the dual therapy (with systolic blood pressure (SBP) â¥140mmHg) will be included. Patients who will initiate the third drug and be on the Bisoprolol + Perindopril+ Amlodipine triple therapy will be compared to those who donât.
The primary outcome will be the difference in change in SBP from baseline to week 8 between the two treatments groups, estimated with a Mixed Model of Repeated Measures. We will also compare diastolic blood pressure change at 8 weeks, blood pressure control at 8 weeks and rates of adverse events between the two treatment groups. Treatment patterns including adherence to index therapy and healthcare resource use will be also described for the triple therapy users. The rates of cardiovascular events including myocardial infarction, stroke, heart failure and chronic kidney disease as well as cardiovascular death will be also investigated as an exploratory objective.
This will be a retrospective cohort study conducted on CPRD linked with HES and death registration data. Exposure sets will be created first by index date (within a time window) and dual-therapy components and then patients will be matched using propensity score to ensure comparability between treatment groups. Missing outcomes due to change in treatment during outcome assessment period will be handled using Baseline Mean Carried Forward imputation method.
These data will be used to generate evidence for the fixed-dose combination (FDC) of perindopril, amlodipine and bisoprolol, currently under development by Servier that may reduce pill burden in hypertensive patients and would improve treatment adherence.
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Developing a prediction model for upper gastrointestinal and pancreatic cancers from patients who have presented to primary care with upper gastrointestinal symptoms. — Raoul Reulen ...
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Developing a prediction model for upper gastrointestinal and pancreatic cancers from patients who have presented to primary care with upper gastrointestinal symptoms.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-02
Organisations:
Raoul Reulen - Chief Investigator - University of Birmingham
Amar Srinivasa - Corresponding Applicant - University of Birmingham
Amar Srinivasa - Collaborator - University of Birmingham
James Martin - Collaborator - University of Birmingham
Lucinda Archer - Collaborator - University of BirminghamOutcomes:
1. Upper gastrointestinal (oesophageal and stomach) cancer diagnosis in patients without symptoms of dysphagia
2. Pancreatic cancer diagnosis.
3. General practitioner compliance with recommendations for referral for suspected upper GI and pancreatic cancer based on symptoms or abnormality in blood tests.
Description: Lay Summary
Cancers of the food pipe (oesophagus), stomach and pancreas make up three of the six cancers with the worst chance of survival. This is often because the cancers are often diagnosed late when it is impossible to cure them. More research is needed to help find these cancers earlier when they are more treatable. Symptoms patients describe and blood test abnormalities associated with these conditions can be missed, leading to delays in diagnosis. Our research aims to help general practitioners (GPs) accurately predict patients at risk of these cancers and refer for urgent investigation. By using large GP data sets containing thousands of individuals, we will analyse patients who already have these cancers diagnosed to create a scoring system, which will highlight to GPs which patients need to be referred urgently to a specialist. Having an accurate scoring system that reliably predicts the presence of these cancers in primary care will be of huge benefit for thousands of patients that may otherwise have their cancer missed or have been referred unnecessarily when there is no real risk of cancer being present. The current referral criteria which guide GPs on which patients require urgent review also needs to be assessed as the chance of cancer in those referred are low (1-3%), however at the same time up to 1 in 5 patients are diagnosed in hospital with late stage disease, suggesting possible missed opportunities to diagnose cancer earlier.
Technical SummaryIntroduction
Each year in the UK: 9200 oesophageal cancer 6595 gastric cancer and 10250 pancreatic cancers are diagnosed. Their prognosis is poor, and these cancers make up 3 of the 6 least survivable cancers â 16% with oesophageal, 19% with gastric and 6.5% with pancreatic cancer survive 5 years (NOGCA report 2021). Only 3% patients that meet the referral criteria for urgent investigation have cancer yet many patients precent late are diagnosed during inpatient admissions, suggesting that the current referral criteria are not selecting the correct patients or not being adhered to.
Aims
1) Develop prediction models for the presence of upper gastrointestinal and pancreatic cancersMethods
A population-based retrospective open cohort study will be undertaken of all patients with symptoms of upper GI (oesophageal and gastric) cancers and pancreatic cancers (identified through Read/SNOMED CT codes) but no formal diagnosis before entering the study. The research team will use backwards stepwise selection or LASSO approach with a Cox proportional hazards regression model to predict the probability a patient will be diagnosed with either pancreatic or upper GI cancers without dysphagia given their risk factors, symptoms and blood tests. We will also assess a cohort of patients that have been referred for specialist review for these suspected cancer and assess whether they met the referral criteria and have been appropriately referred. CPRD data will be linked to HES and ONS data to improve the pick up of patients diagnosed with these cancers.
Outputs
The primary output will be a prediction model which can be integrated into GP electronic record software to allow for accurate identification of patient at high risk of these cancers that present with upper gastrointestinal symptoms.
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Progression of frailty following severe infections: a matched cohort study in individuals aged 65 years and over using the Clinical Practice Research Datalink — Charlotte Warren...
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Progression of frailty following severe infections: a matched cohort study in individuals aged 65 years and over using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-05
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kwabena Asare - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Eleanor Barry - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Georgia Gore-Langton - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ruth Keogh - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Development and progression of frailty
Description: Lay Summary
Frailty is where the bodyâs reserves are wearing out. Frailty typically affects older people, but it is not inevitable with ageing. Nearly half of those admitted to hospital aged 65 years or over are affected by frailty. Frailty costs the UK healthcare system £5.8billion per year. Frail people are less likely to recover well after minor illness or injuries. They are also more likely to get infections. But we do not know whether infections make people become frail more quickly.
Our study will follow very large numbers of people from age 65 years over time. We will compare people with and without infections to see how quickly they become frail. Findings from our study will help doctors work with older people to prevent frailty. Preventing frailty will improve quality of life and help people to live independently for longer.
Technical SummaryWe aim to investigate the relationship between severe infections necessitating hospital admission and development and progression of frailty (assessed using electronic frailty index [eFI], which uses primary-care morbidity coding across 36 deficits, including specific morbidities, symptoms, social issues). While severe infections may affect cognitive and physical function acutely, it is unclear whether they influence trajectories of frailty longer-term. Evidence of an association between infections and increasing frailty would highlight the need for early holistic intervention to improve modifiable risk factors for frailty (with potential to improve resilience, help foster healthy ageing, and limit the physical, emotional and financial burdens of frailty).
We will conduct a matched (age, sex, practice) cohort study of older adults (â¥65years) in HES-linked CPRD Aurum (01-04-2004 to 31-12-2019). Individuals will be eligible from the latest of: study start (01-04-2004); 65th birthday; or one year after practice registration. Individuals will be eligible until the earliest of: study end (31-12-2019); death; registration end; or no further data collected from practice. We will exclude individuals with severe frailty before start of follow-up. We will match without replacement, individuals with severe infections to individuals without infection (1:5) on infection date.
We will compare continuous and categorical change in eFrailty score in individuals with and without severe infection using: 1) regression based on generalised estimating equations to estimate the difference in the conditional mean change in frailty between baseline and each year of follow up (from 1-5 years); and 2) multistate models to explore rates of transition between categorical eFrailty states (fit, and mild, moderate or severe frailty) over time. We will account for potential confounders (e.g., age, sex, deprivation, smoking, harmful alcohol). We will also explore whether the following factors modify the effect of severe infections on frailty: age, sex, deprivation, infection type (bacterial/viral/fungal/parasitic), care home residency, or dementia.
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The Use of Nonacute Opioids in Menopausal and Postmenopausal Women and the Risk of Cardiovascular Disease — Ruth Brauer ...
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The Use of Nonacute Opioids in Menopausal and Postmenopausal Women and the Risk of Cardiovascular Disease
Datasets:GP data, Incident Cardiovascular Disease; Incident Composite CVD (myocardial infarction (MI), stroke, and heart failure); Incident Venous Thromboembolism (VTE)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-02
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Emma Tillyer - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
Incident Cardiovascular Disease; Incident Composite CVD (myocardial infarction (MI), stroke, and heart failure); Incident Venous Thromboembolism (VTE)
Description: Lay Summary
In the UK, most women stop having their periods around age 50, a phase known as menopause. The symptoms of menopause can last many years and make daily activities difficult. Many women experience severe, long-lasting pain after menopause, which isn't related to cancer. This pain can be treated with over-the-counter and prescription medications. Doctors often prescribe opioids to women over 50 for severe pain. However, there are concerns about the long-term use of opioids, such as an increased risk of heart disease (cardiovascular disease âCVDâ).
Additionally, many women are given Hormone Replacement Therapy (HRT) to help with symptoms from hormone changes during menopause. HRT can also affect the risk of CVD, especially if taken before age 50. The effect of long-term opioid use on CVD risk, either alone or with HRT, isnât well understood.
Using patient data from primary care medical centers, we want to measure the risk of CVD in women aged 50 years and older who use opioids to treat pain from conditions other than cancer. Our research goals are to: 1) determine how long-term use of opioids, compared to no opioid use, affects the risk of CVD in women over 50 who do or do not use HRT, and 2) compare how different opioid pain medications impact the risk of CVD in women over 50 with pain from conditions other than cancer. This project will help understand the link between opioid use and CVD risk in women over 50, aiming to improve their overall health outcomes.
Technical SummaryThe proposed research includes a population-based cohort study and a new user active comparator cohort study to investigate the impact of non-acute opioid use on cardiovascular disease (CVD) events in (post)menopausal women (50-79 years) with chronic noncancer pain.
The population-based cohort study aims to understand the association between non-acute opioid use and CVD risk. This study will include a subgroup analysis on hormone replacement therapy (HRT) use in conjunction with non-acute opioid use, exploring potential alterations in CVD risk due to this combination. The active comparator study will compare CVD outcomes for various prescribed opioids to determine differences, if any, in CVD risk. For both studies, non-acute opioid exposure will be defined as â¥2 prescriptions filled continuously for â¥90 days.
The studies will utilize UK healthcare data from CPRD GOLD and Aurum, between 2010 and 2023. Linkages to HES and ONS Death data will be requested to help identify new CVD events and accurate death dates. The primary outcome is a composite CVD endpoint (myocardial infarction, stroke, and heart failure) with secondary analyses of the individual endpoints and an additional endpoint of venous thromboembolism (VTE). Propensity scores (PS) and PS weighting techniques (Standardised Mortality Ratio and Inverse Probability of Treatment Weighting) will adjust for covariates. Outcomes will be measured using incident rates per 1000 person-years, and hazard ratios will be calculated using Cox proportional hazard models (reported with 95% confidence intervals).
Recent surveys and trend studies show that (post)menopausal women are using opioids for pain management, contrary to UK medical guidance. These studies will help women and clinicians understand the potential CVD risk associated with nonacute opioid use and could greatly assist current UK efforts to curtail opioid prescribing and encourage alternative pain treatment use in women of (post)menopausal age who are already at elevated risk for CVD.
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Characterising Patients with Primary Care Prescribed Intermittent Catheterisation in England — Jennifer Davidson ...
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Characterising Patients with Primary Care Prescribed Intermittent Catheterisation in England
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-26
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Sophie Graham - Corresponding Applicant - Evidera, Inc
Andre Ng - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
Number of patients prescribed an IC; Number of patients prescribed an IC by brand; Number of patients prescribed an IC by IC type (gel, hydrophilic standard, hydrophilic discreet, hydrophilic closed standard); Number of patients prescribed an IC by age; Number of patients prescribed an IC by gender; Number of patients prescribed an IC by bladder dysfunction or urinary tract condition (Parkinsonâs disease, cerebrovascular accident, spina bifida, paralytic syndrome, spinal cord injury, diabetes, diabetic or peripheral neuropathy, multiple sclerosis, dementia, benign prostatic hyperplasia, prostate cancer, urethral stricture and pelvic organ prolapse).
Description: Lay Summary
Intermittent catheters (IC) are special medical devices used by people who have trouble emptying their bladder. Such bladder troubles can happen due to many illnesses and injuries, including damage to the spinal cord, problems with the nervous system, or other conditions that affect how the bladder works. ICs help individuals by allowing them to empty their bladders in a controlled way.
Technical Summary
Understanding the amount of people who use ICs, their age, for example, and the health conditions they have will help ensure the planned use of the devices corresponds to the care patients receive. Studying IC use will enable healthcare professionals to identify potential gaps in care and areas for improvement. It will also allow them to assess whether patients are receiving appropriate and timely access to ICs, to ensure that their bladder management needs are adequately met. In the future, this information could also be used to inform better supply and development of ICs to ensure that patients experience better outcomes.
We will use anonymised primary care data to investigate the feasibility of conducting a study to understand the amount of IC use by health conditions of interest. In this feasibility we will assess whether patients who are prescribed ICs have underlying conditions recorded in their medical records to complete a full analysis.ICs are frequently used by patients with spinal cord injuries, neurological disorders, urinary retention, or other medical conditions that affect bladder function. The use of ICs allows these individuals to effectively manage their bladder emptying.
Understanding the patterns of IC usage is crucial as it helps identify the prevalence and frequency of IC use among different patient populations. By analysing the demographic and clinical characteristics of patients who rely on ICs, researchers can gain insights into the specific needs and challenges faced by these individuals.
Moreover, studying the patterns of IC usage enables healthcare professionals to identify potential gaps in care and areas for improvement. It allows them to assess whether patients are receiving appropriate and timely access to ICs, ensuring that their bladder management needs are adequately met. This information can guide the development of strategies to enhance patient outcomes and optimise the provision of ICs.
The aim of this study is to assess the number of patients in England who have a primary care prescribed ICs, and describe their demographic characteristics such as age and gender and IC characteristics such as type (gel or hydrophilic and whether a standard, discreet, or closed) and brand. We will also describe the number and proportion of patients with an IC by specific bladder dysfunction or urinary tract condition. These descriptive summaries will aid in determining whether ICs which are prescribed in primary care reflect overall usage in England to facilitate a full analysis to describe the patient populations who require IC and how ICs are used, for example the type and duration.
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Reference costs for NHS England by population subgroup and 11 common diseases using real-world evidence — Craig Currie ...
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Reference costs for NHS England by population subgroup and 11 common diseases using real-world evidence
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-24
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Harry Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient characteristics; All-cause-mortality; Healthcare resource use; Healthcare costs
Description: Lay Summary
Healthcare resource utilisation refers to how efficiently medical resources are used to provide patient care and achieve positive health outcomes. These resources include medical equipment, facilities, healthcare professionals' time, medications, and finances. In this study, healthcare costs will encompass those from prescriptions, appointments at GP surgeries, hospital admissions and outpatient appointments.
Technical Summary
Our first aim is to explore the utilisation of NHS resources. We will break down costs by gender, ethnicity, age, body mass index (BMI), smoking status and index of multiple deprivation (IMD). Following this, we will analyse the relationship between an individualâs annual cost to the Nation al Health Service (NHS) and their likelihood of survival.
Our second aim is to estimate healthcare costs in people diagnosed with 11 common diseases in the UK. These diseases will be diverse in the age group they affect, and the body system involved. We will compare healthcare resource use in people with one of the diseases of interest with a group of people that do not have the disease.
It is important to look at patterns of resource utilisation so we can assess which conditions are most costly to the NHS. Understanding healthcare costs of the general population plays an important role in planning NHS services and areas to focus on for future research and development. It can also help policymakers decide how best to allocate funding.We aim to provide NHS reference costs by population subgroup and for 11 common diseases. Acceptable patients eligible for linkage to the Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Outpatient datasets, and the Office for National Statistics (ONS) death registration data will be selected. Healthcare resource use will comprise primary care contacts, primary care prescriptions, outpatient attendances and hospital admissions.
In stage 1, patients will be selected from the Clinical Practice Research Datalink (CPRD) Aurum dataset if they were registered at their GP practice on the 1 January 2019 (the index date). The end of follow-up will be defined as the end of recorded data. Costs accrued in the year following index date will be estimated and stratified by gender, ethnicity, age, BMI, smoking status and IMD. We will model survival as a function of cost.
In stage 2, we will select patients with a medical code recorded in CPRD Aurum or HES APC data for one of the following disorders: neck of femur fracture, stroke, breast cancer, prostate cancer, eating disorders, type 2 diabetes, osteoporosis, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, eczema and attention deficit hyperactivity disorder (ADHD). Follow-up will start on the later of the 1 January 2009 and the patient's registration date. Follow-up will end at the end or recorded data. Incident patients will be selected if their presentation date (the first record of the condition of interest) occurs at least 180 days after registration. Costs will be compared with a non-exposed control group matched in a 1:1 ratio on age, sex and general practice.
These analyses will provide valuable information on the UK healthcare burden associated with common diseases and provide reference costs to inform healthcare decision-making.
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Relational continuity of care in the development and management of chronic pain in primary care — Tom Marshall ...
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Relational continuity of care in the development and management of chronic pain in primary care
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-19
Organisations:
Tom Marshall - Chief Investigator - University of Birmingham
Lauren Waughray - Corresponding Applicant - University of Birmingham
Brian Willis - Collaborator - University of BirminghamOutcomes:
New diagnosis of chronic pain;
Opioid prescriptions.Description: Lay Summary
Relational continuity of care is where the patient sees the same general practitioner for most of their appointments. It is important because it is generally preferred by patients, particularly older patients or those with ongoing medical conditions. It allows patients and doctors to get to know each other and build positive relationships. Patients consistently report that a good doctor-patient relationship is the most important factor in how satisfied they feel with their care. It is also linked to better care. Patients who do see the same doctor for most appointments, tend to have fewer appointments, fewer unplanned hospital visits and a better understanding of how to use any medication prescribed.
Chronic pain (pain persisting for longer than 12 weeks) affects about a third of UK adults. Chronic pain is a complex, deeply personal condition. The treatment of chronic pain is challenging for both patients and their doctors. Traditional treatment options, such as strong pain killers (opioids) are often ineffective and carry additional risks for the patients such as unpleasant side-effects or the risk of addiction. Relational continuity of care maybe an important factor in reducing the development of chronic pain and reducing the use of opioids in its treatment. A well-established relationship between the patient and doctor could help patients better understand and cope with their pain and subsequently reduce the need for opioids.
This study will investigate the effects of relational continuity of care on the development of chronic pain and on the prescribing of opioids.
Technical SummaryThe aim of the study is to investigate the relationship between relational continuity of care (RCC) and the development and management of chronic pain in primary care.
Chronic pain is a debilitating condition affecting millions of people in the UK alone and is associated with significant economic and health care costs. It is often treated with opioids, which are ineffective in the long-term and expose patients to the risk of adverse effects, potentially serious adverse events and dependency.
Psychological factors are important in the development of chronic pain. Therefore, it is plausible that the nature of the ongoing therapeutic doctor-patient relationship may affect progression to chronic pain by influencing how patients cope with potentially painful diagnoses. RCC also affects both prescribing and deprescribing so could also affect the short and long-term use of opioids by patients with chronic pain.
The aim of this study is to investigate the effects of RCC (exposure) on the development of chronic pain and on the frequency, dose, and duration of opioid prescribing (outcome) for chronic pain.
The study will be a retrospective cohort study. It will include adult patients with a new diagnosis that has the potential to cause pain (e.g. low back pain, endometriosis or an episode of surgery) and a group of controls without this diagnosis. Multivariable regression analysis will be used to investigate the association between RCC at baseline and the subsequent incidence of chronic pain and of opioid prescribing, adjusting for potential confounders (e.g. age, gender, socioeconomic status, ethnicity, long term mental and physical health conditions). It will also investigate the role of ongoing RCC later in the diagnostic and treatment pathway.
An understanding of the role of RCC in the development and management of chronic pain could offer practical implications for clinical management of patients with painful conditions.
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The Excess Risk of Death Outcomes Study (ERDOS) in Chronic Obstructive Pulmonary Disease (COPD): A real-world study to understand the leading causes and excess risk of mortality in people living with COPD using the CPRD in England — Michael Pollack ...
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The Excess Risk of Death Outcomes Study (ERDOS) in Chronic Obstructive Pulmonary Disease (COPD): A real-world study to understand the leading causes and excess risk of mortality in people living with COPD using the CPRD in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-06
Organisations:
Michael Pollack - Chief Investigator - Astra Zeneca Inc - USA
Nisha Hazra - Corresponding Applicant - Analysis Group Ltd
Chunyi Xu - Collaborator - Analysis Group, Inc.
Hana Mullerova - Collaborator - AstraZeneca Ltd - UK Headquarters
Kirsten Gallant - Collaborator - Analysis Group, Inc.
Marianne Cunnington - Collaborator - Analysis Group, Inc.
Mu Cheng - Collaborator - Analysis Group, Inc.Outcomes:
Mortality is the primary outcome of interest for this study. All-cause and then, separately, COPD-related, lung cancer-related, and cardiovascular disease (CVD)-related mortality will be assessed, as well as other leading causes of mortality (top 5).
Death dates will be identified using linked ONS death registration data, and cause-specific mortality will be derived from the primary cause of death noted in the linked ONS data based on ICD-10 codes.
Description: Lay Summary
People with chronic obstructive pulmonary disease (COPD) suffer breathing problems leading to lung damage and respiratory symptoms. COPD has increasingly been recognised as a major cause of death worldwide. People with COPD can experience âlung attacksâ or âflare upsâ called exacerbations, that may result in the need for hospitalization. Although previous studies have evaluated common causes of death in people with COPD, recent information is lacking. Further, little is understood about how the mortality burden of COPD compares with other common health conditions. This study aims to understand current patterns of death, overall and from specific causes, among people with COPD in England. Rates of death will be compared in people with COPD and in people without COPD, with and without other chronic diseases, specifically heart failure (HF), breast cancer (BC), and prostate cancer (PC). Additionally, the risk of death in people with COPD following hospitalization for an exacerbation will be described and compared to the risk of death in people without COPD following hospitalization for other acute events, including heart attacks. The risk of death in people with COPD with and without hospitalization for exacerbations will also be explored. This study will fill critical evidence gaps on causes of death in people with COPD during the past decade as well as the additional risk of death associated with COPD and its complications. New data from this study will inform on the possible benefits of earlier diagnosis, treatment, and management of COPD.
Technical SummaryCOPD, a leading cause of death worldwide, is a respiratory disease that presents clinically with airflow limitation and extensive respiratory and non-respiratory symptomatology (i.e., dyspnoea, sputum production, sleep disturbance). People with COPD suffer from exacerbations, triggered by environmental and lifestyle factors. Severe exacerbations may result in hospitalization. Specific causes of death remain poorly understood and evidence on current mortality compared to other chronic diseases are missing.
This study aims to describe leading causes of death, all-cause, and cause-specific mortality in people with COPD in England between 2014 and 2020, using CPRD linked to hospital and death data. Mortality rates and risk during follow up will be compared between people with COPD and people without COPD, with and without other chronic diseases, specifically, heart failure (HF), prostate cancer (PC), and breast cancer (BC), separately. COPD and comparative cohorts will be identified based on Read and/or SNOMED/EMIS codes in CPRD, with comparative cohorts matched 3:1 to the COPD cohort using exact matching on key socio-demographic characteristics.
To understand the impact of acute worsening of COPD, mortality rates and risk will also be described amongst people with COPD hospitalized for an exacerbation and compared to matched people with COPD without a hospitalized exacerbation and matched people without COPD hospitalized for other acute events (i.e., myocardial infarction [MI]). Hospitalization events will be identified using previously published algorithms.
Mortality rates will be compared between groups using Poisson regression, with excess mortality reported as rate differences. Kaplan-Meier (KM) analyses will be used to describe overall survival (OS) and 12-month OS during follow up, with comparative risk of death assessed using a Cox proportional hazards model. This study will provide new information on mortality trends and excess mortality in people with COPD, supporting the potential benefits of earlier diagnosis, treatment, and management of COPD.
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Glucagon-like peptide-1 receptor agonists and the risk of nonarteritic anterior ischemic optic neuropathy in patients with type 2 diabetes — Samy Suissa ...
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Glucagon-like peptide-1 receptor agonists and the risk of nonarteritic anterior ischemic optic neuropathy in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Yunha Noh - Collaborator - Sungkyunkwan UniversityOutcomes:
Nonarteritic anterior ischemic optic neuropathy (NAION) (based on the Read codes and SNOMED-CT concept IDs outlined in Appendix 1).
Description: Lay Summary
Nonarteritic anterior ischemic optic neuropathy (NAION), also known as an eye stroke, occurs when there is a sudden loss of blood flow to the eye nerve, and its symptoms include sudden, painless vision loss in one eye, often noticed upon waking. Eye stroke is a medical emergency because the vision loss can be permanent. Patients with high blood sugar levels have a higher risk of eye stroke compared to those without. There is a safety issue that a common blood sugar-lowering drug, called glucagon-like peptide-1 receptor agonists (GLP-1 RAs), may increase the risk of developing eye stroke. However, the current evidence is limited. Thus, in this study, we will use data from the Clinical Practice Research Datalink database to assess whether the use of GLP-1 RAs is associated with an increased risk of eye stroke, compared with the use of another blood sugar-lowering drug class, dipeptidyl peptidase-4 (DPP-4) inhibitors. This study will provide information that helps clinicians and patients to make more informed decisions when deciding on the most appropriate medication in patients with high blood sugar levels.
Technical SummaryGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) are being increasingly prescribed among patients with type 2 diabetes. Concerns are being raised about a potential risk of nonarteritic anterior ischemic optic neuropathy (NAION) associated with the use of GLP-1 RAs; however, the limited available evidence has important methodological limitations. Thus, the objective of this population-based study is to determine whether the use of GLP-1 RAs is associated with an increased risk of developing NAION when compared with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. To address this objective, we will use the Clinical Practice Research Datalink database to identify patients at least 18 years of age newly treated with a GLP-1 RA or a DPP-4 inhibitor between January 1, 2007 and March 31, 2024. Cox proportional hazard models will be used to estimate hazard ratios of NAION with 95% confidence intervals associated with GLP-1 RAs compared with DPP-4 inhibitors. Secondary analyses will assess whether there is a duration-response relation, and whether the risk varies by individual GLP-1 RAs and patient characteristics, such as age, sex, and smoking status. This study will provide much-needed information about the safety of increasingly prescribed GLP-1 RAs in patients with type 2 diabetes.
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Trends in the prescription of oral anticoagulants in adults with Chronic Obstructive Pulmonary Disease in United Kingdom Primary Care (2010-2022) — Samy Suissa ...
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Trends in the prescription of oral anticoagulants in adults with Chronic Obstructive Pulmonary Disease in United Kingdom Primary Care (2010-2022)
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-13
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Brianna Murray - Collaborator - McGill University
Christel Renoux - Collaborator - McGill UniversityOutcomes:
First prescription of OAC, including VKAs, or DOACs (dabigatran, rivaroxaban, apixaban, or edoxaban), in patients with COPD, overall and by age, sex, COPD severity, CHA2DS2-VASc score, and HAS-BLED score; baseline characteristics of patients newly prescribed DOACs, and separately for patients newly prescribed VKAs; baseline characteristics associated with DOAC initiation, as compared to VKA initiation; incidence of AF diagnosis in patients with COPD, overall and by age and sex.
Description: Lay Summary
Chronic obstructive lung disease (COPD) is a common progressive lung disease that severely impairs breathing and leads to long-term health complications, reduced quality of life, and heightened healthcare needs. Patients with COPD are often also impacted by cardiovascular disease, including atrial fibrillation (AF), a common heart rhythm disorder that increases the risk of stroke and other heart-related complications. Current guidelines recommend that AF is treated the same in patients with COPD and in patients without COPD, and vice versa. Oral anticoagulants (OACs) are a medication often prescribed to patients with AF for stroke prevention, yet little is known about the current patterns in prescribing OACs to patients with AF and COPD. This study will use data from the Clinical Practice Research Datalink (CPRD) to determine how common AF is in patients with COPD and to describe the patterns in prescribing OACs to this group of patients over time. The information obtained from this study will help fill current gaps in knowledge and practice regarding the use of OACs in patients with COPD. This is important as it will guide future research on strategies to optimize the treatment of AF in patients with COPD.
Technical SummaryChronic Obstructive Pulmonary disease (COPD) is commonly associated with cardiovascular disease requiring additional pharmacological treatment. In particular, oral anticoagulants (OAC) are commonly prescribed to patients with cardiac comorbidities, such as atrial fibrillation (AF), and for the prevention of venous thromboembolism. However, there is a lack of information on the prescribing trends of OACs, including vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) in patients with COPD.
The objective of this study is to quantify the incidence (number of new cases) of AF in patients with COPD and to describe the patterns of OACs prescribed to these patients. In addition, we will describe the patient characteristics associated with a first prescription of VKAs as compared with DOACs.
Using the United Kingdom Clinical Practice Research Datalink, the yearly incidence rates of AF in adults with COPD, as well as those who were subsequently prescribed an OAC in the United Kingdom (UK) between 2010 and 2022, will be calculated using a Poisson model. This model will also be used to calculate prescription rates of VKAs and DOACs separately and for individual DOACs (apixaban, dabigatran, edoxaban, rivaroxaban). We will also describe prescription patterns according to age, sex, COPD severity, CHA2DS2-VASc score, and HAS-BLED score in stratified analyses. Lastly, we will describe baseline characteristics by calendar period of patients prescribed a DOAC or a VKA. We will determine the baseline characteristics associated with DOAC initiation using multivariate logistic regression.
The results of this study will provide a comprehensive description of the prescription trends over time of OACs in patients with multimorbid COPD, and the profile of patients prescribed these drugs. This information may facilitate future research on best practices for treating patients with COPD and comorbid cardiovascular disease.
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Genital warts diagnoses in young people attending primary care services — Katherine Soldan ...
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Genital warts diagnoses in young people attending primary care services
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-12
Organisations:
Katherine Soldan - Chief Investigator - UK Health Security Agency (UKHSA)
Lucinda Slater - Corresponding Applicant - UK Health Security Agency (UKHSA)
Claudia Adighije - Collaborator - UK Health Security Agency (UKHSA)
Marta Checchi - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
Number and rate (per 100,000 person years) first episode and recurring genital warts diagnoses, stratified by gender, year, ethnicity and Index of Multiple Deprivation (IMD).
Description: Lay Summary
Human papillomavirus (HPV) is a very common virus, which most people will be infected with at some point in their lifetime. There are many types of HPV and while infection with most are unlikely to cause any symptoms, some types, known as high-risk types, can cause cervical and other anogenital cancers, and some low-risk types can cause genital warts. A national school-based HPV vaccination programme for adolescent girls aged 12-13 was introduced in 2008, and extended to boys in 2019. UKHSA has reported declines in genital warts diagnoses at sexual health services since the programmeâs introduction. Earlier (unpublished) analyses of CPRD Aurum data from 2009-2019 confirmed declines in genital warts diagnoses were also being seen in patients attending GP services in England. This study will update previous analyses investigating trends in genital warts diagnoses: now that rates are very low in sexual health services, it is timely to document and publish the corresponding data from primary care. While data from sexual health services show attendances and diagnoses were greatly affected by Covid-19 pandemic, it is not yet clear how this affected attendances and diagnoses in primary care settings. It is also timely to monitor the effects of the gender-neutral vaccination programme. There is evidence to suggest that HPV vaccine uptake has been lower among Black and Asian ethnic groups than other ethnic groups. We will investigate any inequalities in HPV-associated genital warts diagnoses in the primary care setting by breaking these trends down by ethnicity and by level of deprivation.
Technical SummaryThis study will provide a descriptive retrospective ecological analysis investigating trends in genital warts diagnoses in primary care from 2009-2023. We will determine rates of first episode and recurring genital warts diagnoses per 100,000 person-years, using population denominators determined from all patients registered within CPRD for groups of interest. Diagnosis rates and percentage declines will be stratified by age group (15-17, 18â20, 21â24, 25-29, and 30â34 year-olds), gender, ethnicity, regional geographies, and Index of Multiple Deprivation (IMD) quintile. Poisson regression will be used to test for trends in and factors associated with diagnoses. We will investigate any inequalities in HPV-related genital warts diagnoses by examining trends by ethnicity and IMD. We will also compare these trends with diagnoses made in sexual health services reporting data to the GUMCAD STI surveillance system held by the UK Health Security Agency, and look at any changes in service-use by age groups over time using both datasets, to investigate if there is any evidence of a decline in diagnoses in GUMCAD that is due to a change of service use (i.e. increases in diagnoses in primary care). We will carry out a descriptive comparison of both trend plots (CPRD vs GUMCAD) by a visual comparison of the slopes to check if the gradient of trend is the same. We will compare the p values for trend from the Poisson regression for each service type. Rate of diagnoses in primary care are lower than in sexual health clinics (GUMCAD), so any displacement of patients should be evident in plots of CPRD data. If CPRD data is showing an increasing trend, then we will assess whether those have caused the decreases in GUMCAD (i.e. the rate change in GUMCAD) and the potential impact of those case numbers in sexual health clinics.
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Sickle Cell Disease and Transfusion-dependent beta-thalassaemia: Clinical Burden of Disease in England — Rachel Armstrong ...
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Sickle Cell Disease and Transfusion-dependent beta-thalassaemia: Clinical Burden of Disease in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-09-18
Organisations:
Rachel Armstrong - Chief Investigator - IQVIA Ltd ( UK )
Sophia Fleming - Corresponding Applicant - IQVIA Ltd ( UK )
Aaro Salosensaari - Collaborator - IQVIA Finland Oy
Elena Chaparova - Collaborator - IQVIA Solution Bulgaria EOOD
Erik Landfeldt - Collaborator - IQVIA Solutions Sweden AB
Nikolay Trankov - Collaborator - IQVIA Solution Bulgaria EOOD
Quratul Ann - Collaborator - IQVIA Ltd ( UK )Outcomes:
The main outcomes of interest for this study are:
Acute complications in primary and/or secondary care ( such as gallstones, acute renal failure, cerebral vasculopathy, infections, post-hyphaemia glaucoma, retinal infarction, splenic infarction, stroke, transient ischaemic attack, vaso-occlusive crisis); severe SCD chronic complications in primary and/or secondary care (such as leukocytosis, bone and joint problems, cardiopulmonary complications, chronic leg ulcers, chronic pain, complications of pregnancy, delayed puberty, erectile dysfunction, functional asplenia, hepatobiliary complications, hyposplenism, hyposthenuria, infertility, liver complications, malignancies, mental health problems, myelodysplastic syndrome, neurocognitive impairment, proteinuria, renal complications, retinopathy/retinal disorders); transfusion dependent beta-thalassaemia (TDT) complications in primary and/or secondary care (such as cardiopulmonary complications, endocrine complications, bone disorders, liver complications, malignancies, mental health problems, myelodysplastic syndrome, renal complications, splenomegaly, urinary tract complications); medical prescriptions (such as hydroxycarbamide, iron chelation therapies, penicillin, folic acid, pain relieving medications); medical procedures (transfusions, splenectomy); health care resource utilization (HCRU) in primary care (general practice visits, nurse visits, prescriptions recorded in primary care); HCRU in secondary care (accident and emergency admissions, outpatient visits, inpatient hospitalizations, all non-transfusion admissions, all overnight admissions); and mortality.Description: Lay Summary
Hemoglobinopathies are among the most common inherited blood disorders worldwide and encompass different types of blood disorders, notably sickle cell disease (SCD) and transfusion dependent beta-thalassaemia (TDT). Both SCD and TDT interfere with the delivery of oxygen from the lungs throughout the body. SCD is associated with pain crisis (also called vaso-occlusive crisis) which occurs when the sickle-shaped cells transporting the oxygen into the tissues have become stuck in the blood vessel in for example, the bones, chest, or penis area (also known as priapism). This event often requires emergency hospitalisation. Other heart, blood vessel, bone or joint problems can also occur which require lifelong supportive care and intensive treatments. Similarly, TDT can result in lifelong complications such as anaemia (where a person does not have enough healthy red blood cells), as well as liver, heart and blood problems. For these patients, regular blood transfusions are administered with iron chelation drugs to lower risk of issues caused by high iron levels due to the disease and the blood transfusions. SCD and TDT disease management include a range of resources such as visits to the doctor, hospital care, and prescription medications (for example pain medications). The overall aim is to determine the patientsâ clinical characteristics, complications of the disease and probability of developing complications and death. This will provide crucial insights into how patients are managed in England, improve the understanding of current unmet need in SCD and TDT.
Technical SummaryThis is a longitudinal, retrospective cohort study evaluating the magnitude of clinical burden in patients with sickle cell disease (SCD) and transfusion-dependent beta-thalassaemia (TDT) using primary care records (Clinical Practice Research Datalink (CPRD) linked with secondary care data (Hospital Episode Statistics (HES) in a real world setting in England. Overall, the study will include patients from 2008 to 2022. Two study populations will be described, one with patients who have SCD regardless of the VOC frequency, and the other with TDT. The SCD cohort will include patients who have a primary or secondary diagnosis of SCD. The TDT cohort will include patients who have a primary or secondary diagnosis of beta-thalassaemia and ⥠8 transfusions per year in 2 consecutive years. The index date for SCD will be the date the patient has a SCD diagnosis, and the index date for beta-thalassaemia will be the date the patient meets the severity criterion, i.e., the first date with ⥠8 transfusions per year in 2 consecutive years within the study eligibility period. The study will describe baseline characteristics and follow-up characteristics such as acute complications, chronic complications, and all-cause mortality and report risk-adjusted hazard ratios for clinical complications and mortality, derived using Cox models. This research will provide crucial insights into how patients are managed in England and improve the understanding of current unmet need in SCD and TDT.
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ID-424: Multimorbidity patterns and unplanned health service use among children and young people in North West London
— Imperial College London...
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ID-424: Multimorbidity patterns and unplanned health service use among children and young people in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity.
Source
2024 - 08
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HM Revenue and Customs Research Future Strategy — unknown...
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HM Revenue and Customs Research Future Strategy
Where: unstated
When: 2024-8-7
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This HM Revenue and Customs (HMRC) project will explore options for widening access to its tax data for research, in order to expand and enhance the evidence available to decision makers for tax policy and operations.
Research carried out using HMRC data can provide valuable insights for HMRC, HM Treasury, and other government departments. This can inform their research priorities, policymaking, and service delivery for the public good.
Using ADR UK funding, this work to progress HMRCâs future strategy will look to improve tax research through three broad objectives:
Assess current cataloguing and governance of HMRCâs data used for research purposes against future research needs Research ways to improve the quality, coverage, and accessibility of HMRC data used by external researchers. Produce costed options for HMRC Datalabâs future strategy and remote access Facilitate greater engagement between HMRC and the research community to drive improved insights that meet HMRC research needs in the future.
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Incidence, management, and impact of sleep disturbance in children and adolescents with atopic dermatitis: a retrospective matched cohort study in the UK — Melissa Watkins ...
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Incidence, management, and impact of sleep disturbance in children and adolescents with atopic dermatitis: a retrospective matched cohort study in the UK
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Melissa Watkins - Chief Investigator - Pfizer Inc - US Headquarters
Emma Jones - Corresponding Applicant - Momentum Data Ltd
Andrew McGovern - Collaborator - Momentum Data Ltd
Anita Lynam - Collaborator - Momentum Data Ltd
Carsten Flohr - Collaborator - King's College London (KCL)
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Muhammad (Ashkan) Dashtban - Collaborator - Momentum Data Ltd
Serhan Bahit - Collaborator - Momentum Data LtdOutcomes:
Sleep disturbance will be identified in the primary care record. A final code list will be developed based on the provisional list in Appendix 1. Prior to finalizing this outcome, the impact of extending the outcome definition to include treatment specific to sleep disturbance (i.e. melatonin prescription) but without a diagnosis code for sleep disturbance will be explored.
Medication includes non-sedating antihistamines, sedating antihistamines and melatonin.
Mental health outcomes: Common mental health conditions in children and adolescents [8]; comprising anxiety, depression [9], ADHD, and behavioural disorders.
Description: Lay Summary
Eczema, also known as atopic dermatitis, is a common skin condition affecting 1 in 10 children. One of the biggest problems with eczema is the itching, especially at night. This can make it hard for children to fall and stay asleep, leading to nearly an hour less sleep each night compared to children without eczema. Not getting enough sleep can affect a child's mood, behaviour, and learning. It can also make it tough for parents and siblings to get a good night's rest.
Treating both itching and sleep problems can be tricky. Some older allergy medications (sedating antihistamines), can help but these medications should only be used for a short period. Melatonin is a natural hormone in the body that helps regulate sleep. Sometimes doctors prescribe melatonin to help with sleep problems. Previous studies have suggested that melatonin might be helpful for children with eczema. We're interested in learning more about the which of these treatmentsâ doctors are prescribing for children with eczema and sleep problems.
We also want to explore why some children with eczema are more at risk of having sleep problems than other children. We're interested in seeing if children who struggle with both eczema and sleep issues are more likely to experience anxiety, depression, or other mental health challenges.
This research will help doctors understand which children with eczema are most at risk of sleep problems. Getting a better understanding can help ensure that children with both eczema and sleep problems get the support they need.
Technical SummaryAtopic dermatitis (AD) is the most common skin condition in childhood, affecting 9.6% of children [1]. AD has been associated with sleep disturbance [2-6], which can impact on behaviour [2], school and work [3, 6, 7]. Large-scale population-based research is need to investigate the total burden of sleep in children and adolescents with AD, as well as identifying which groups are at greatest risk of sleep disturbance and the subsequent impact it can have on mental health.
We will use a matched cohort study to assess the risk of sleep disturbance in children with active AD. Primary outcomes will be the relative risk of sleep disturbance in those with active AD compared to unaffected controls, including across subgroups, using Kaplan-Meier survival functions and Cox proportional hazard models. As a secondary objective we will also compare mental health outcomes in children with AD with and without sleep disturbance.
We will investigate the relative use of medications, including sedating antihistamines, non-sedating antihistamines and melatonin, in children with active AD with and without sleep disturbance, using unadjusted prescribing rates (prescriptions per 100 person years) and Poisson regression models. We will describe changes in prescribing trends of these medications over the last 20 years.
The study cohort will include children and adolescents aged 2-17 years registered in CPRD Aurum with active AD between March 1, 2003 and March 1 2023. Active AD will be defined using a combination of specific diagnosis codes and two or more AD related treatments prescribed on different dates. Cases will be matched up to 1:4 with unaffected controls at the same GP practice. A combination of time-dependent propensity score and exact matching will be applied, based on age, sex, ethnicity, socioeconomic deprivation and duration of practice registration.
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The association between Parkinson's disease and levodopa prescription and the development of age-related macular degeneration — Nicola Adderley ...
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The association between Parkinson's disease and levodopa prescription and the development of age-related macular degeneration
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Nicola Adderley - Corresponding Applicant - University of Birmingham
Jingya Wang - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Rasiah Thayakaran - Collaborator - University of BirminghamOutcomes:
In both Cohorts 1 and 2, outcome is age-related macular degeneration (AMD).
Description: Lay Summary
Age-related macular degeneration (AMD) is the most common cause of blindness in people over 50 years in the UK. 90% of vision loss in AMD is due to wet AMD. Wet AMD is treated by frequent injections into the eye; while effective, these are expensive and painful.
Parkinsonâs disease is a progressive disease affecting the nervous system, causing symptoms such as tremors, rigidity, uncontrollable movements and sleep issues. Around 1 in 500 people in the UK have Parkinsonâs disease.
AMD and Parkinsonâs disease are degenerative disorders, and the risk of both diseases increases as people get older. Some studies have shown an increased risk of developing Parkinsonâs disease among people with AMD. However, there is no large study exploring whether people with Parkinsonâs disease have an increased risk of developing AMD.
Levodopa is a medication commonly prescribed to treat Parkinsonâs disease. Recent evidence suggests that levodopa may improve outcomes for people with wet AMD and reduce how often they need to have injections in their eye, or even delay the development of AMD. However, the association between levodopa and prevention of AMD has not been explored in a large UK dataset.
The aims of our study are to explore the associations between:
1. Parkinsonâs disease
2. levodopa
and the risk of developing AMD.If our study provides evidence of a protective effect of levodopa, the medication would be a candidate for further evaluation in clinical trials for prevention of AMD, particularly in patient groups at high risk of developing AMD.
Technical SummaryAims:
To explore the association between 1. Parkinsonâs disease, 2. Parkinsonâs disease medications (levodopa) and development of AMD.Study design:
Cohort 1 comparing people with and without Parkinsonâs disease: A matched retrospective open cohort study to explore the association between Parkinsonâs disease and development of AMD. Exposed and unexposed participants will be matched in a 1:2 ratio by age (±1 year), sex, and general practice on the index date.
Cohort 2 comparing people with Parkinsonâs disease prescribed levodopa to those not prescribed levodopa: A retrospective open cohort study with levodopa drug prescriptions as a time-varying exposure variable.
Study period is 01/01/1995 to 01/07/2021.Population:
Cohort 1: Adults aged â¥40 years.
Cohort 2: Adults aged â¥40 years with a diagnosis of Parkinsonâs disease.Exposures:
Cohort 1: Parkinsonâs disease.
Cohort 2: Levodopa prescription.Outcome:
Age-related macular degeneration.Covariates:
We will include the following covariates in the adjusted models: sociodemographic characteristics (sex, age at index, ethnicity), smoking status, body mass index (BMI), comorbidities (hypertension, myocardial infarction, stroke, heart failure, diabetes, arthritis, diabetic retinopathy, glaucoma, cataract) and lipid-lowering drugs.Analysis:
Cohort 1: A Cox proportional hazards model will be used to estimate hazard ratios with 95% confidence intervals for development of AMD in those with Parkinsonâs disease compared to those without, adjusting for the above covariates.
Cohort 2: An extended Cox proportional hazards model will be used to estimate hazard ratios for the development of AMD in patients with Parkinsonâs disease prescribed levodopa compared to those not prescribed levodopa, adjusting for the above covariates.
The proportional hazards assumption will be checked using log-log plots and the Schoenfeld residuals test.Public health benefits: If our study provides evidence of a protective effect, levodopa would be a candidate for evaluation in clinical trials for prevention of AMD, particularly in patients at high risk of developing AMD.
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Feasibility of determining patients with different forms of hypercholesterolemia and their frequency of cardiovascular disease — Christine Barnett ...
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Feasibility of determining patients with different forms of hypercholesterolemia and their frequency of cardiovascular disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Christine Barnett - Chief Investigator - RTI Health Solutions ( USA )
Jean-Gabriel Le Moine - Corresponding Applicant - RTI Health Solutions ( USA )
Adrian Vickers - Collaborator - RTI Health Solutions ( USA )
Deirdre Mladsi - Collaborator - RTI Health Solutions ( USA )
Qiang Hao - Collaborator - RTI Health Solutions ( USA )
Sorrel Wolowacz - Collaborator - RTI Health Solutions ( USA )Outcomes:
Primary outcomes. Measurements of low-density lipoprotein cholesterol (LDL-C) over time; Percentage of participants achieving LDL-C levels < 135 mg/dL; First hospitalisation for any cardiovascular (CV) disease; Subsequent hospitalisation for any CV disease; CV death; All-cause death.
Secondary outcomes. Hospitalisation for coronary heart disease; Myocardial infarction; Hospitalisation for ischaemic stroke or transient ischaemic attack; Hospitalisation for peripheral arterial disease; Revascularisation procedure; Stable angina; Unstable angina.
Description: Lay Summary
Homozygous familial hypercholesterolemia (HoFH) is a rare genetic condition in which fatty compounds known as low-density lipoprotein cholesterol accumulate in the blood from an early age. People with this condition face a high risk of cardiovascular (CV) diseases even in childhood. The objective of this study is to understand how the risks of CV death and hospital admission due to CV events change over time among patients with HoFH, in comparison with patients with less severe forms of hypercholesterolemia. These include a less severe genetic form of the condition, heterozygous familial hypercholesterolemia, and a form where the patientâs condition is not thought to have a direct genetic cause, known as non-familial hypercholesterolemia. The feasibility study will determine whether general practice data provided by the Clinical Practice Research Datalink (CPRD) combined with hospital admission data and death registration data can be used to accomplish this objective.
The information obtained from this study will assist an informed choice to be made about treatment options for HoFH. A comparison will be made of the degree of unfavourable outcomes (including hospitalization or death due to CV disease) in HoFH compared to those in other forms of hypercholesterolaemia. This will indicate whether the available data for the more common conditions can be adapted to assist in therapy choices with a view to improving the care of patients with HoFH.
Technical SummaryFuture study
To estimate the relative risk over time of hospital admission for cardiovascular (CV) disease (including primary and secondary events and CV mortality) among patients with homozygous familial hypercholesterolemia (HoFH) who received standard of care, in comparison with patients with heterozygous familial hypercholesterolemia (HeFH), unspecified familial hypercholesterolemia (FH), and non-familial hypercholesterolemia (non-FH). HoFH is rare condition, resulting in a lack of data available to inform decision making. This study may benefit patients with HoFH by comparing the rate of adverse outcomes in HoFH to those with more common forms of hypercholesterolaemia, thus potentially allowing data for the more common conditions to be adapted or adjusted to inform decision making in HoFH.
Feasibility study
The aim is to determine:
- The number of patients diagnosed with HoFH and FH for which HoFH or HeFH is not specified.
- The presence of any genetic test results which might indicate whether people with FH may be classified as either HoFH or HeFH.
- The total number of patients who can be classified as HoFH.
- The age distribution of patients with HoFH.
- The total patient-time for patients with HoFH.
- The amount of patient-time for patients with HoFH, that would remain if patient-time after first receipt of lomitapide is excluded.
- The feasibility of creating a sample of patients with non-FH who are age-matched to the patients with HoFH.
- The number of patients with HoFH, in age bands at time of event, who have a first CV hospitalization event, a subsequent CV hospitalization event or a CV-related death.An algorithm will be implemented for determining HoFH based on the presence of genetic test results and other diagnoses such as for FH for which HoFH or HeFH is not specified. The algorithm will be used to determine the above.
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Social prescribing amongst people with severe mental illnesses: Are individuals with cardiovascular risk more or less likely to be referred? What are the characteristics of those referred and the impact on health service use? An analytical cohort study. — Alexandra Burton ...
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Social prescribing amongst people with severe mental illnesses: Are individuals with cardiovascular risk more or less likely to be referred? What are the characteristics of those referred and the impact on health service use? An analytical cohort study.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-07
Organisations:
Alexandra Burton - Chief Investigator - University College London ( UCL )
Alexandra Burton - Corresponding Applicant - University College London ( UCL )
Alvin Richards-Belle - Collaborator - University College London ( UCL )
Amy Taylor - Collaborator - University College London ( UCL )
Daisy Fancourt - Collaborator - University College London ( UCL )
David Osborn - Collaborator - University College London ( UCL )
Feifei Bu - Collaborator - University College London ( UCL )
James Bailey - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Naomi Launders - Collaborator - University College London ( UCL )
Stephanie Tierney - Collaborator - University of Oxford
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
Social prescribing rates, Number of GP visits, number/rates of hospitalisations and Accident and Emergency visits (HES).
Description: Lay Summary
Severe mental illnesses (SMI) are psychological problems that severely affect a personâs ability to function in everyday life. People with SMI are more likely to die from heart disease and stroke and to die earlier than people without SMI.
A doctor can refer patients to a link worker who can support them to access community health and wellbeing activities e.g. peer support, gardening, exercise, arts, volunteering, employment support and financial advice. This is called social prescribing, and it could help to reduce the risk of heart disease and stroke by reducing loneliness, stress or increasing peopleâs physical activity.
We donât currently know whether people with SMI are accessing social prescribing or whether it supports their health.
We will look at if:
⢠age, gender, ethnicity, or health conditions make people with SMI more or less likely to be offered social prescribing.
⢠people with SMI and risk factors for heart disease and stroke, such as obesity, high blood pressure and diabetes, are less likely to be offered social prescribing than those without SMI who have the same risk factors for heart disease and stroke.
⢠social prescribing helps people by seeing if the number of doctor appointments and hospital admissions among people with SMI changes after they receive social prescribing.
This will help us to understand if more needs to be done to support people with SMI to access social prescribing and if it can be used to support their health and reduce the risk of heart disease and stroke.
Technical SummaryPeople with SMI may benefit from social prescribing but may be less likely to be offered it than other patients. There is limited evidence about the health conditions of patients receiving social prescribing and its effectiveness.
Using a sample of all individuals with social prescribing codes in CPRD Gold and Aurum, we will describe patterns of social prescribing code usage in UK adults by time and place and describe the characteristics of those referred to social prescribing in terms of demographics and health conditions. This analysis is not restricted to individuals with SMI but will aid the understanding of later analyses because social prescribing has not been described within CPRD before.
Then, using a sample of all individuals with active diagnosed SMI in CPRD Aurum, we will determine characteristics of individuals offered social prescribing. We will compare the odds of being offered social prescribing by age, sex, ethnicity, region, deprivation, loneliness, CVD risk, medication prescriptions, physical and mental health conditions.
Within CPRD Aurum, we will use Cox regression to investigate the impact of social prescribing on health service usage amongst individuals with SMI by comparing number of GP visits, hospital admissions and A&E usage (using HES data) between individuals referred and not referred to social prescribing.
Within CPRD Aurum, we will use Cox regression to assess whether social prescribing rates are similar in those with SMI and each of the following CVD risk factors: diabetes, hypertension and obesity compared to those with these CVD risk factors and no SMI. For each individual with SMI and CVD risk factors we will sample i) 6 controls with common mental health disorders (depression, anxiety, stress) and CVD risk factors and ii) 6 controls with no mental illness and CVD risk factors. Cases will be matched to controls by age, sex and GP practice.
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Glucagon-like peptide-1 Receptor Agonist therapy prescribing for patients with type 2 diabetes mellitus in the UK: an analysis on eligibility and variabilities in prescribing — Samuel Seidu ...
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Glucagon-like peptide-1 Receptor Agonist therapy prescribing for patients with type 2 diabetes mellitus in the UK: an analysis on eligibility and variabilities in prescribing
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-01
Organisations:
Samuel Seidu - Chief Investigator - University of Leicester
Yogini V Chudasama - Corresponding Applicant - Leicester Diabetes Centre
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Kamlesh Khunti - Collaborator - University of Leicester
Katrien Wijndaele - Collaborator - Eli Lilly and Company Ltd. (UK)
Kunal Gulati - Collaborator - Eli Lilly & Co - UK
Lill-Brith von Arx - Collaborator - Eli Lilly & Co - UK
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
⢠T2D patients eligible for GLP-1 RA therapy according to the NICE Guidelines (NG28)
⢠T2D patients prescribed GLP-1 RA therapyDescription: Lay Summary
Type 2 diabetes is a serious long-term condition that causes a personâs blood sugar level to become too high. There are many medications to help lower blood sugar levels, but there are still a large number of patients who do not reach their target blood sugar level, are overweight, and are at high risk for heart problems.
We want to look at a relatively new class of drug for type 2 diabetes called âGlucagon-like peptide-1 receptor agonists (GLP-1 RAs)â. Research suggests they may be better at reducing blood sugar, losing weight, and lowering heart problems, than other type 2 diabetes drugs. In the United Kingdom, doctors follow national guidelines to help them decide how to prescribe medicines and when it is the right time for the patient to be eligible for the medication.
This study will look at how many patients with type 2 diabetes are eligible for the GLP-1 RA drug and need this medicine based on the national guidelines, and how many are being prescribed it. We will look at different factors such as age, gender, ethnicity and the location of the patients, to understand if certain groups are more or less likely to be prescribed GLP-1 RAs.
We will make use of the large primary care databases to better understand the findings in the real world. The results from our study will provide important information, about whether the drug is reaching the right patients with type 2 diabetes and help with primary care clinical decision-making.
Technical SummaryRationale and background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a well-established class of therapy offering glycaemic reduction with the added benefit of weight loss and, for some UK available agents in the class, cardiovascular protection. The NICE Guidelines (NG28) recommend GLP-1 RAs as a third-line agent in patients with type 2 diabetes mellitus (T2D). However, to date few studies have investigated the real-world application of these NICE Guidelines, using data from UK primary care settings, overall, and by region, sex, and ethnicity.
Research question and objectives: The primary aims of this project are to: 1) describe the proportion of UK T2D patients eligible for GLP-1 RA therapy according to the NICE Guidelines (NG28) overall, and by region, sex and ethnicity; and 2) to describe the proportion of those receiving a GLP-1 RA therapy, overall, and by region, sex and ethnicity. Secondary aims include examining the disease characteristics and social demographics of the cohort receiving a GLP-1 RA therapy, annual rates of prescribing, and variables which are more or less likely to lead to GLP-1 RA prescription overall, and by sex and ethnicity.
Study design: Retrospective cohort study
Population: Patients aged â¥18 years with a diagnosis of T2D
Variables: Cohort demographics, clinical characteristics, comorbidities, T2D medications
Data sources/Data Collection: Clinical Practice Research Datalink (CPRD) GOLD and Aurum database
Study size and/or Study Power: Feasibility count based on patients aged â¥18 years and with T2D between 01 Jan 2005 to 31 Dec 2014, with the GOLD Build: the total GOLD IDs: 253,764, and Aurum Build: the total Aurum IDs: 1,778,854. The proposed sample size will provide sufficient numbers to achieve the study objectives.
Statistical analysis: For primary objectives, we will use descriptive analysis, and for secondary objectives use statistical models including logistic regression, Poisson regression, and time-to-event analysis.
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Patterns of Pharmacological Treatments for Type 2 Diabetes among Children and Youths in the United Kingdom — Samy Suissa ...
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Patterns of Pharmacological Treatments for Type 2 Diabetes among Children and Youths in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-13
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
Cristina Longo - Collaborator - University Of Montreal
In-Sun Oh - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
SUNG HO BEA - Collaborator - Brigham & Women's HospitalOutcomes:
1. Annual prescription rate of anti-diabetic drugs, classified by class between 2002 and 2022
2. Total number of yearly prescriptions between 2002 and 2022
3. Percentage of patients using anti-diabetic drugs among aged 16-20 years patients between 2002 and 2022
4. Treatment trajectories and patterns of T2DM careDescription: Lay Summary
Type 2 diabetes mellitus (T2DM) is a condition characterized by elevated blood sugar levels. While it most commonly occurs in adults, its occurrence among children and adolescents has increased rapidly over the past two decades, primarily due to the obesity epidemic. Youth-onset T2DM is associated with a high risk of complications of diabetes (e.g., stroke, heart attacks, blindness), leading to increased morbidity and mortality at a younger age than those diagnosed later in life. Paediatric patients with T2DM present distinctive characteristics that differ from those observed in adults. There is a lack of treatment options for paediatric patients with T2DM, and the transition from paediatric to adult care is particularly challenging. Furthermore, fragmentation in health care delivery can lead negatively impact cost, quality, and outcomes of care. As new oral antidiabetic agents become available for adults, it is important to explore changes in treatment patterns during the transitional period from paediatric to adult care. To address this knowledge gap, we will use the Clinical Practice Research Datalink (CPRD) to describe prescription trends and treatment patterns among children and youths with T2DM, including during transition period (ages 16-20 years). Similar analyses will be conducted using data from Korea. The findings from this study will provide comprehensive information of the usage of antidiabetic medications in this young population.
Technical SummaryOver the past two decades, the prevalence of type 2 diabetes mellitus (T2DM) has increased rapidly among children and adolescents in the UK, with over 120,000 children and adolescents now diagnosed with T2DM. Understanding treatment patterns for this population is crucial for maintaining their quality of life and preventing complications. While the 2022 American Diabetes Association and 2023 National Institute for Health and Care Excellence (UK) guidelines recommend certain treatment options, off-label use of other drugs may occur. There is also a lack of evidence about treatment patterns in a real-world setting and during the transition from paediatric to adult care (ages 16-20 years), which is important given the availability of various oral antidiabetic agents approved for adults.
To address these gaps, we propose to describe prescription rates, prescription trends, and treatment trajectories of antidiabetic drugs for T2DM among children and youths between 2002 and 2022. We will use Poisson regression to estimate annual prescription rates and corresponding 95% confidence interval (CIs) overall and in subgroup analyses defined by age groups, sex, and glycated hemoglobin level. The prescription rate ratio between the last and first year of the study period for each drug class will also be estimated overall and in these subgroups. Secondary endpoints will include changes in treatment subgroups across antidiabetic drug classes. The treatment subgroups will be identified by using group-based multi-trajectory models with a systematic procedure to characterize the model. In addition, we will repeat analyses for patients aged 16-20 years (transition period) to observe changes in the annual percentage of patients and treatment trajectories across antidiabetic drug use as they age. Analyses will be repeated using population-based data from Korea; all analyses will be stratified by country.
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A feasibility study examining availability of data on diagnosis of multiple long-term conditions and inflammatory risk factors, and considering variables including age, gender, race, socioeconomic status, education and other factors. — Alexander MacGregor ...
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A feasibility study examining availability of data on diagnosis of multiple long-term conditions and inflammatory risk factors, and considering variables including age, gender, race, socioeconomic status, education and other factors.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-29
Organisations:
Alexander MacGregor - Chief Investigator - University of East Anglia
Charlotte Davies - Corresponding Applicant - University of East Anglia
Ailsa Welch - Collaborator - University of East Anglia
Daniel Asfaw - Collaborator - University of East Anglia
Elena Kulinskaya - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Min Aung - Collaborator - University of East Anglia
Mizanur Khondoker - Collaborator - University of East Anglia
Soumya Subhra Paria - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tahmina Zebin - Collaborator - Brunel University LondonOutcomes:
1. First diagnosis of long term conditions including: CVD (cardiovascular disease), cancer, chronic kidney disease, COPD (chronic obstructive pulmonary disease), dementia, depression, diabetes, Parkinsonâs disease, MS (multiple sclerosis), Rheumatoid arthritis, asthma, chronic liver disease and heart failure.
2. Chronic inflammation biomarkers including CRP, ESR, ferritin, proxy blood biomarkers including Hb, WBC and platelets, other proxy indices including blood neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, combinations of albumin and CRP, transferrin, iron, fibrinogen.Description: Lay Summary
This feasibility study forms the first part of a programme of work supported by the National Institute for Health and Care Research (NIHR) in which we are applying advanced statistical and computing tools (artificial intelligence) to large national and international datasets to examine how MLTC (Multiple Long Term Conditions) develop in individuals over their lives.
One in four of the UK population have MLTC. It is one of the greatest challenges currently facing individuals and health services. Our study focusses on the role of chronic inflammation and nutrition. Chronic inflammation refers to the bodyâs natural ability to respond to outside threats, such as fighting an infection. This lies at the root of many diseases including heart disease, type 2 diabetes, arthritis, and dementia.
We propose to examine the availability and completeness of the data in Clinical Practice Research Datalink (CPRD) Aurum, HES APC (Hospital Episode Statistics Admitted Patient Care) and IMD (Index of Multiple Deprivation) on important factors including the number of diagnosed long term conditions, inflammatory markers (typically measured by specific blood tests), demographic and socioeconomic factors including age, sex and ethnicity. This will allow us to identify whether there is enough data on the factors of interest to develop a full CPRD protocol application examining the risk factors leading to the development of MLTC.
It is anticipated that the findings of this research will inform the development of targeted interventions in primary care, such as risk alerts, ultimately reducing the burden of MLTCs on individuals and healthcare systems.
Technical SummaryWe aim to use CPRD Aurum, HES APC and IMD to explore the availability of data on MLTCs and inflammation risk factors, according to date and intersectionality variables.
Objectives are:
1. to examine counts of new diagnoses of long-term conditions (LTC) recorded in CPRD and/or HES APC, in patients aged 40+ years, according to year, age, sex, ethnicity and index of multiple deprivation.
2. to explore the completeness and distribution of specific inflammation variables including inflammatory markers such as: CRP (C reactive protein), ESR (erythrocyte sedimentation rate), ferritin, and proxy blood biomarkers including Hb (hemoglobin), WBC (white blood cell count) and platelets, according to year, age, sex, ethnicity and IMD.
We aim to explore the completeness of this data for assisting the development of a full CPRD application examining risk factors for the development of MLTCs.We will summarise the number of MLTC at baseline and the number of incident MLTC measured longitudinally at predefined landmark points by gender, age group, ethnicity and IMD quintile.
We will present descriptive statistics to describe the number of MLTC and the distribution of the exposures (inflammatory markers) and covariates including means, standard deviations and the interquartile ranges.The findings of this feasibility stage of the study will inform the development of a full CPRD protocol which we anticipate will lead to the development of targeted interventions in primary care, such as risk alerts, ultimately reducing the burden of MLTCs on individuals and healthcare systems.
Source -
Clinical relevance of neutrophil and associated blood tests in primary care: a prospective cohort study of cancer incidence using English electronic medical records and cancer registry data — Sarah Bailey ...
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Clinical relevance of neutrophil and associated blood tests in primary care: a prospective cohort study of cancer incidence using English electronic medical records and cancer registry data
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-16
Organisations:
Sarah Bailey - Chief Investigator - University of Exeter
Tanimola Martins - Corresponding Applicant - University of Exeter
David Shotter - Collaborator - University of Exeter
Elizabeth Shephard - Collaborator - University of Exeter
Luke Mounce - Collaborator - University of Exeter
Sarah Price - Collaborator - University of ExeterOutcomes:
Outcomes: The main outcomes for the research aims above are:
Aim 1. The neutrophil-to-lymphocyte ratio, determined from the neutrophil and lymphocyte counts.
Aims 2 and 7. An incident cancer diagnosis recorded in NCRAS within 1 year of the index date. In this context, incident means first ever record of a cancer in NCRAS, excluding non-melanoma skin cancer. We will include all cancers except non-melanoma skin cancer (ICD10 C44), and testicular and cervical cancers (whose peak incidence occurs â¤40 years).
Aim 3. The probability of any cancer diagnosis given the neutrophil-to-lymphocyte ratio value, and change in that value over time, for all patients and for those with selected comorbidities.
Aim 4. The probability of an individual cancer diagnosis given the neutrophil-to-lymphocyte ratio value, and change in that value over time, for all patients and for those with selected comorbidities.
Aim 5. The probability of any cancer diagnosis given the neutrophil-to-lymphocyte ratio value and the presence or absence of cancer symptom(s) in the 28 days before the index date
Aim 6 (a). Cancer stage at diagnosis (dichotomised as advanced (stages 3 or 4) or early (stages 1 or 2)) Aim 6 (b). Death within 1 year of the index date, determined from ONS and CPRD variables.
Aim 7. See above (Aim 2 and 7)
Aim 8. As above, for other elements of a full blood count including red cell count, haemoglobin levels, white cell counts, platelets count, red cell distribution width, and mean corpuscular volume.Update July 2024:
Cancer incidence in patients with an abnormal test result in this context is equivalent to the positive predictive value (PPV) of the test, which equates to risk.
We have updated the data linkage section. We had a misunderstanding about the source of deprivation data and have updated the entire eRAP to reflect that we will use ONS for data of death for survival analysis, and IMD for deprivation data.Description: Lay Summary
Background
Previous studies have showed the importance of blood tests ordered by General Practitioners (GPs) in helping to detect cancer earlier. One in four adults have a full blood test over a year and using these results to look for unusual signs could lead to earlier diagnosis and better outcomes.This study will build on the researchers' existing work by researching a link between different types of cancers and the multiple blood counts, including âneutrophil to lymphocyte ratioâ. Neutrophils and lymphocytes are different types of white blood cells; the body produces them when fighting infections.
Abnormal results can indicate inflammation in the body which could be caused by an undetected cancerous tumour. Previous studies have indicated that the âneutrophil to lymphocyte ratioâ could be of particular importance when reviewing survival for patients already diagnosed with several cancer types, however it has never been considered as a tool to aid diagnosis of these cancers.
The aim of this study is io understand how abnormal blood test results predict multiple cancer types. Blood test results will be reviewed to understand what types of results are followed by the patient developing a cancer. The outcomes of this study will provide valuable information and advice to GPs, who may order routine blood tests which revel a high âneutrophil to lymphocyte ratioâ and from here understand the likelihood of cancer.
Technical SummarySeveral blood tests including neutrophil to lymphocyte ratio (NLR) have been shown to be useful prognostic markers of several cancer types. We have experience of studying blood tests (including thrombocytosis and microcytosis) as diagnostic markers of cancer and integrating these findings into practice. This application will extend that work to NLR and other routine blood tests.
Aims
1. Explore the distribution of the neutrophil-to-lymphocyte ratio.
2. Quantify the association between the neutrophil-to-lymphocyte ratio and an incident cancer diagnosis.
3. Determine the neutrophil-to-lymphocyte ratio that confers an excess cancer risk of 3% or greater.
4. Quantify a hierarchy of cancer risk by site, over and above that expected by age and sex, in patients
with an abnormal neutrophil-to-lymphocyte ratio, to inform cancer investigative strategies in these
patients.
5. Explore what additional risk, if any, is conferred by the presence of cancer symptoms recorded in the 28
days before the blood test.
6. Quantify the association between neutrophil-to-lymphocyte ratio and cancer outcomes, such as stage
and 1-year survival.
7. Explore whether the neutrophil-to-lymphocyte ratio adds additional utility in cancer risk prediction over
known cancer biomarkers.
8. Repeat the above for other blood tests.Methods
Retrospective cohort study. Patients with a blood test from 01/01/2012-31/12/2018 will be included. Exposure: value of the neutrophil-to-lymphocyte ratio. Outcomes: incident cancer diagnosis. Statistical analysis: descriptive analysis of cancer
incidence and neutrophil to lymphocyte counts in the cohort. Mixed-effects logistic regression, stratified by
age and sex, will test associations between the neutrophil-to-lymphocyte ratio and an incident cancer
diagnosis (or stage at diagnosis, depending on the aim being addressed), with random effect for general
practice. One-year net survival will be modelled using the non-parametric Pohar-Perme estimator.The data sources requested are described in the relevant section below.
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Investigating which symptoms, tests and medications are associated with lymphoma diagnosis in the primary care population: a case control and cohort study — Clare Bankhead ...
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Investigating which symptoms, tests and medications are associated with lymphoma diagnosis in the primary care population: a case control and cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-22
Organisations:
Clare Bankhead - Chief Investigator - University of Oxford
Tara Seedher - Corresponding Applicant - University of Oxford
Brian Nicholson - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Micheal McKenna - Collaborator - University of Oxford
Robert Williams - Collaborator - University of OxfordOutcomes:
Study 1:
Incident diagnosis of Lymphoma recorded in either CPRD, HES, or NCRAS, between 1st January 2001 and 1st January 2023Study 2
Incident diagnosis of Lymphoma in recorded in either CPRD, HES or NCRAS, between 1st January 2001 to 1st January 2023Both studies will record all-cause mortality and socioeconomic/deprivation status using ONS and IMD datasets on top of CPRD. HES will also be used to obtain hospitalisation data, frequency of admissions.
Description: Lay Summary
Lymphoma is a blood cancer, the fifth most common cancer type in the UK. It can affect all areas of the body, at any age. The two main types are: Hodgkin (HL) and Non-Hodgkin lymphoma (NHL). Lymphoma can only be detected through specialist, secondary care hospital services, accessed through general practitioner (GP) referrals.
Lymphoma patients often experience delays in diagnosis, which are associated with advanced disease and poor survival. Lymphoma patients are more likely to have multiple GP consultations before hospital referral, less likely to have an urgent GP referral and have an increased risk of diagnosis after emergency presentation. The reasoning for delayed diagnosis is three-fold. Firstly, lymphoma symptoms are non-specific and can often be mistaken for other less serious illnesses; these include tiredness and fevers. Secondly, there are inadequate tests to detect lymphoma. Thirdly, GPs have limited exposure to lymphoma, and the current referral guidelines exclude the wider range of symptoms experienced in patients.
Our first study will determine patterns that occur prior to a lymphoma diagnosis, exploring the differences in features (symptoms, blood test results and prescribed medications) of healthy patients and lymphoma patients in general practice. The second study will create a prediction tool using these features to calculate the risk of patients developing lymphoma. We will obtain data from GPs of patients of all ages and utilize Statistical modelling analysis methods.
This research will develop diagnostic tools to alert GPs to a patientâs risk of lymphoma, allowing timely referrals and expedited diagnosis.
Technical SummaryLymphoma is a haematological cancer that develops in the lymphatic system. It is the fifth most common cancer, with over 14,000 people diagnosed annually in the UK. Lymphoma is classified into Hodgkin lymphoma and the more common subtype Non-Hodgkin lymphoma.
Lymphoma diagnosis is often delayed. Lymphoma is frequently diagnosed after multiple GP referrals and following emergency presentation, associated with poor survival. Diagnostic delays within primary care can be attributed to the non-specific presenting symptoms, also associated with common benign conditions and the lack of reliable investigative tests.
This project aims to expedite lymphoma diagnosis by identifying symptoms, tests and medications (clinical features) to guide GP referrals for suspected lymphoma. Incident lymphoma diagnosis will be measured for patients of all ages.
A case-control study using conditional logistic regression models will examine the association between clinical features and a lymphoma diagnosis compared to age and sex matched controls, deriving odds ratios for up to 5 years prior to date of lymphoma diagnosis. Diagnostic accuracy statistics including sensitivity, specificity and positive and negative likelihood ratios will be calculated for individual and combined clinical features.
Using a cohort design, we will derive and validate a prediction model including the clinical features identified in the case-control study. Cox proportional hazard models will be used to estimate the risk of a lymphoma diagnosis within 5 years.
Derivation and validation datasets will be created based on geographical region. Calibration and discrimination statistics will assess model performance in the validation dataset, these include R2 statistics and ROC curves.
Source - and 29 more projects — click to show
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Cost-effectiveness of Shingrix vaccination and revaccination in immunocompetent and immunosuppressed adults in England: a repeated cross-sectional study and economic modelling analysis — Nicholas Davies ...
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Cost-effectiveness of Shingrix vaccination and revaccination in immunocompetent and immunosuppressed adults in England: a repeated cross-sectional study and economic modelling analysis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-23
Organisations:
Nicholas Davies - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nicholas Davies - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anne Suffel - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Chu-Chang Ku - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Edward Parker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Eleanor Barry - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcomes: incidence of herpes zoster (shingles); incidence of postherpetic neuralgia; incidence of zoster-related hospitalisation; incidence of zoster-related mortality
Secondary outcomes: incidence of non-zoster-related (background) mortalityDescription: Lay Summary
Shingles is a painful rash that about one in four people in England get at least once, usually as older adults. Most of the time, the rash heals after 2â4 weeks, but about one in 20 people with shingles get postherpetic neuralgia (PHN). PHN causes severe pain that lasts from 3 months to many years and can make peopleâs quality of life worse.
The same virus that causes chickenpox causes shingles. After someone recovers from chickenpox, the virus stays in their body for the rest of their life. Shingles happens when the virus wakes up and damages a personâs nerves. Older people and people with weaker immune systems are more likely to get shingles and PHN.
There is no cure for shingles, but vaccines can prevent it. In 2013, the NHS started offering a shingles vaccine called Zostavax to people aged 70-79. This has protected many people from shingles. Now there is a new vaccine, called Shingrix, that works better than Zostavax and can be used in people with weaker immune systems too.
The NHS has asked us to answer four questions to help them to make decisions about Shingrix:
Technical Summary
(1) Should Shingrix be given to people over 80?
(2) Should people who got the older vaccine (Zostavax) now take Shingrix?
(3) Should older people take a booster dose of Shingrix to stop the protection from wearing off?
(4) Should people with weaker immune systems take booster doses of Shingrix?We will conduct a cost-effectiveness analysis of Shingrix vaccination in adult immunocompetent and immunosuppressed populations in England.
We will estimate the age-specific incidence of shingles and postherpetic neuralgia in adults aged 18 and older in single-year age bands, by study year over the period 1st September 2003 to the latest available data at the time of the study, in both immunocompetent and immunosuppressed adults. We will define individuals with immunosuppression using relevant primary-care recorded morbidity codes and prescriptions. We will estimate cases of shingles and PHN by using primary and secondary care records for zoster and for PHN diagnosis and treatment. We will also estimate zoster-related mortality and background mortality using linked ONS death data. Zoster incidence will have decreased since 2013 due to the use of the Zostavax vaccine; we will use previously estimated vaccine effectiveness [15] and UKHSA-provided age- and year-specific uptake data to adjust for this decrease to understand what incidence rates may have been in the absence of vaccination. We will use the measured incidence rates to project the incidence of shingles and PHN forwards for use in our cost-effectiveness model, omitting data from the COVID-19 pandemic years due to reduced contact with health care during this time.
Then, we will use a Monte Carlo decision tree model to estimate the potential impact of different Shingrix vaccination strategies, including: (1) vaccination of elderly individuals aged 80+ who have not yet received shingles vaccination; (2) revaccination of Zostavax recipients with Shingrix; (3) a booster dose of Shingrix for elderly individuals once the Shingrix vaccine is offered to 60-year-olds; and (4) booster doses of Shingrix for immunosuppressed individuals. We will ascertain the most cost-effective vaccination strategies by calculating incremental cost-effectiveness ratios and calculating the threshold price at which a vaccination strategy becomes cost-effective.
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Assessment of the association between use of doxycycline and suicide: a self-controlled case series and an active comparator study — Daniel Prieto...
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Assessment of the association between use of doxycycline and suicide: a self-controlled case series and an active comparator study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-14
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Marta Pineda Moncusi - Corresponding Applicant - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
Outcomes of interest are:
- Completed suicide (included in cohort study only).
- Composite outcome of completed suicide (included in cohort study only), suicide ideation, suicide attempting and self-harm.
- Composite outcome of depression or anxiety.Description: Lay Summary
Doxycycline is an antibiotic widely used for treating bacterial infections including respiratory and sexually transmittable diseases, acne and rosacea (a redness on the face that may also present small bumps with pus inside). There have been reports on a potential association between use of doxycycline and suicide. Assessing this potential association is crucial for understanding the full safety profile of doxycycline and ensuring patient safety. This can be done by evaluating the risk of suicide or self-harm events in patients using doxycycline compared to other drugs that can be used (called active comparators).
Hence, this study aims to 1) evaluate if there is a causal association (i.e., a cause-and-effect relationship) between the use of doxycycline and suicide-related events; and 2) to evaluate if the association between doxycycline use and completed suicide and suicide-related events vary by the recorded indication of use (e.g., acne, chlamydia, etc.), when compared to active comparators.
Public health benefits from the study: it is crucial to assess whether there is a connection between doxycycline and suicide in order to guarantee the safety of doxycycline users.
Technical SummaryDoxycycline, a tetracycline antibiotic, is widely used for treating bacterial infections. There have been reports on a potential association between use of doxycycline and suicide.
This study aims to 1) evaluate if there is a causal association between the use of doxycycline and suicide-related events; and 2) evaluate if the association between doxycycline use and completed suicide and suicide-related events vary by indication of use, compared to active comparators.
>Study design: Cohort studyand Self-controlled case series (SCCS)
>Population:
-New-user cohort study: patients with a first prescription of doxycycline or active comparator.
-SCCS study: patients with a prescription of doxycycline and a record of the outcome within the study period (01/01/2010-actuality).
Patients will be excluded if the start date in the database or occurrence of the outcome falls within 365 days prior to the index date as this does not guarantee sufficient database history to track information on covariates.>Exposure: new users of doxycycline
>Outcomes:
-Completed suicide (included in cohort study only).
-Composite outcome of completed suicide (included in cohort study only), suicide ideation, suicide attempting and self-harm.
-Composite outcome of depression or anxiety.>Covariates:
- Age
-Calendar year
-Seasonality
-Patient specific characteristics in terms of indications of interest, conditions, etc.>Analyses:
1) Incidence rates of the suicide-related events, depression or anxiety in people using doxycycline
2) Incidence rate ratios in a SCCS study between doxycycline and the study outcomes.
3) Propensity-score matching of patients prescribed doxycycline to active comparators in new-user cohort within different indication of use. Then cox-proportional hazards regression will estimate hazards ratios to assess the association of doxycycline with study outcomes.Public health benefits: it is crucial to assess whether there is a connection between doxycycline and suicide in order to guarantee the safety of doxycycline users.
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Impact of diclofenac pharmacovigilance interventions in patients with arthritic conditions or acute musculoskeletal disorders — Helga Gardarsdottir ...
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Impact of diclofenac pharmacovigilance interventions in patients with arthritic conditions or acute musculoskeletal disorders
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Helga Gardarsdottir - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Satu Johanna Siiskonen - Collaborator - Utrecht University
Tomas Lasys - Collaborator - Utrecht University
Yared Santa Ana Tellez - Collaborator - Utrecht UniversityOutcomes:
- The quarterly incidence of diclofenac and its alternatives. It will be estimated and defined as the number of incident users during the quarter of interest divided by the person-time in days of the whole database population during that quarter divided by the number of days in that quarter.
- Proportion of initiators of diclofenac and its alternatives in patients that meet selected indications for diclofenac prescription. It will be estimated by the number of diclofenac or its alternatives initiators in the quarter divided by the number of patients that meet indication for diclofenac during that quarter.
- The quarterly prevalence of diclofenac and its alternatives . It will be estimated and defined as the number of prevalent users during the quarter of interest divided by the person-time in days of the whole database population during that quarter divided by the number of days in that quarter.
- The quarterly discontinuation rates of diclofenac and its alternatives. It will be estimated as the number of patients with a prescription for diclofenac that did not receive a new prescription for diclofenac at least 90 days after the end of estimated exposure.
- Proportion of discontinuers of diclofenac and its alternatives in patients that meet selected indications for diclofenac prescription. It will be estimated by the number of diclofenac or its alternatives initiators in the quarter divided by the number of patients that meet indication for diclofenac during that quarter.
- The average dose and duration of diclofenac use trend during the study period.
- The average diclofenac dose and treatment duration before and after the intervention.Description: Lay Summary
Diclofenac is a medicine that helps with pain and swelling in conditions like arthritis (a condition that causes pain, swelling, and stiffness in the joints, which are the places where two bones meet)) and gout (a type of arthritis). In 2013, the European Medicines Agency raised concerns about its safety. They took steps to reduce the risks, such as advising doctors when not to give diclofenac to patients, especially those with heart problems or a history of stroke. They also warned against its use in people with high blood pressure, high cholesterol, and diabetes (a disease where the body has trouble controlling blood sugar).
Researchers have studied how these safety steps have affected the general use of diclofenac, but it's not clear how they have impacted people who really need it for arthritis or muscle and joint problems. This project aims to find out how these safety measures have influenced the use of diclofenac and its alternatives in patients at higher risk of side effects, like those with heart disease, high blood pressure, high cholesterol, and diabetes. The goal is to see if these measures have changed the treatment choices and outcomes for these patients.
Technical SummaryA population-based longitudinal observational study will be conducted using data from the CPRD database to examine anti-inflammatory drug prescription patterns and trends of health outcomes related to the use of diclofenac and its alternatives. The study population will consist of all patients registered with the CPRD database during the study period who will be followed up until death, end of follow-up or end of registration. The population of interest will be selected based on recorded diagnoses that are considered indications for diclofenac (arthritic conditions, acute musculo-skeletal disorders, or other painful conditions). The outcomes of interest will be changes in prescribing patterns of diclofenac and its alternatives. We will use interrupted time series regression to determine whether statistically significant changes in prescribing were associated with regulatory interventions. The outcomes will be assessed based on patients risk profile (no documented risk, documented risk factors such as high blood pressure, high cholesterol, and diabetes, or documented contraindications such as heart failure, heart disease, peripheral artery disease, or stroke history). The primary goal of the study is to assess the impact of risk minimisation measures (RMMs) targeting diclofenac, taking into account the possible unintended effects of RMMs on the use of diclofenac alternatives.
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Assessing the incidence of symptoms referred to as Breast Implant Illness (BII) within primary care in England. — Svetlana Buzdugan ...
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Assessing the incidence of symptoms referred to as Breast Implant Illness (BII) within primary care in England.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Svetlana Buzdugan - Chief Investigator - MHRA
Svetlana Buzdugan - Corresponding Applicant - MHRA
Sophie Scanlon - Collaborator - MHRAOutcomes:
Frequency of symptoms known as BII in primary and/or secondary care
Description: Lay Summary
Breast implants are Class III medical devices positioned between breast tissue and chest muscle or behind the chest muscle to increase the breast size (augmentation) or replace breast tissue (reconstruction). There are two types of implants: silicone gel-filled implants and saline-filled implants. Both implants have a silicone outer shell.
Soon after their first use in the 1960s, breast implants have been anecdotally linked with systemic symptoms and have been the subject of several reviews and monitoring. Since 2017, MHRA has been receiving a large volume of spontaneous incidents reporting a variety of health problems which are suspected to be related to their breast implants. There has also been significant media interest in the occurrence of a variety of symptoms in relation to breast implants, which were termed âbreast implant illnessâ. This resulted in a peak of reports being received in 2019. The reports are not linked to a particular manufacturer or type of implant and include silicone and saline-filled implants.The term 'breast implant illnessâ (BII) refers to a variety of symptoms that occur after getting breast implants. It is not a recognised medical diagnosis and is commonly self-reported by patients.
Technical Summary
This study is aimed at defining the group of symptoms commonly reported in association with breast implants and characterising the incidence and prevalence of these symptoms in a population with and without breast implants.A. Technical Summary (Max. 300 words)
Breast implant illness (BII) is an informal term and refers to a wide range of symptoms that may occur in people with breast implants. It is not a recognised medical condition; however, the term is used frequently online to describe symptoms that people can experience following cosmetic breast augmentation or reconstructive breast surgery with implants. It can also be known as breast implant disease, autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and silicone implant illness. Reports of symptoms, sometimes referred to as Breast Implant Illness (SRABII), have been received via the Yellow Card scheme by the MHRA since 2017.
A study using CPRD data on breast implant surgery can assist in defining the BII and examining an association between breast implants and systemic symptoms.
A cluster analysis will, therefore, aim to explore and group a range of symptoms reported after breast implant surgery, quantify their frequency in recipients of breast implants and compare them between indications and the types of surgery. After establishing a diagnosis in a cluster analysis, we will employ Cox regression analysis on general practice data linked to HES data to investigate the possible association and temporal relationship between breast implant surgery and an increased risk of the occurrence of BII in the UK. Our study population will be all breast implant recipients identified in the Aurum CPRD and HES data. The study will aim to characterise the symptoms of BII, provide an estimate of the relative incidence of BII, and examine the risk period post-surgery and the characteristics of patients with a diagnosis of symptoms relevant to BII. The study will be used alongside other evidence to advise on the need for regulatory action and communication on this issue.
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Effect of thiazolidinediones on preventing vascular dementia in type 2 diabetes in the UK — Joyce (Yun...
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Effect of thiazolidinediones on preventing vascular dementia in type 2 diabetes in the UK
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-14
Organisations:
Joyce (Yun-Ting) Huang - Chief Investigator - University of Manchester
Joyce (Yun-Ting) Huang - Corresponding Applicant - University of Manchester
- Collaborator -
David Jenkins - Collaborator - University of Manchester
Li-Chia Chen - Collaborator - University of Manchester
Martin Rutter - Collaborator - University of ManchesterOutcomes:
Incident vascular dementia; Incident mixed dementia; Incident Alzheimer's disease
Description: Lay Summary
Currently, there is no targeted treatment available for vascular dementia, the second most common type of dementia, leading to a pressing need to prevent vascular dementia. People with vascular dementia usually have other complex health conditions, and this contributes to them having a shorter life expectancy compared to people with Alzheimer's.
Technical Summary
Recent studies from the US and China suggest thiazolidinediones (TZDs), a class of diabetes drugs, have the potential to reduce the chances of developing all types of dementia in people with type 2 diabetes. However, previous studies are limited because they did not consider underlying health conditions and treatments for vascular dementia and only studied limited populations. Therefore, results cannot be applied to a broader population.
Therefore, we hypothesise that TZDs can protect the brain by preventing vascular disease and thereby prevent vascular dementia. We will use new methods to investigate the association between TZD use and the chance of developing vascular dementia in people with type 2 diabetes identified using the GP records, CPRD Aurum. Then, we will evaluate how changes in diabetes treatments and their dose over time are related to risks for developing vascular dementia.
Our project is expected to discover whether existing antidiabetic drugs can be used to prevent other diseases that they were not originally intended to use. The evidence may support future clinical studies testing the impacts of TZD on people with cognitive function and/or vascular dementia. Consequently, this research can lead to quicker and less expensive drug development to prevent vascular dementia.Background: Vascular dementia is the second most common type of dementia that has no targeted treatments available, and its complex underlying cardiovascular and cerebrovascular comorbidities contribute to a shorter lifespan than those with Alzheimer's disease. TZDs, a class of oral antihyperglycemic agents, have shown a reduced risk of all-cause dementia and vascular dementia in people with type 2 diabetes mellitus (T2DM). However, existing evidence on TZD use and vascular dementia is limited by methodological issues in assessing drug exposure, comorbidities and treatments driving vascular dementia, and results have limited generalisability.
Aims: This study aims to investigate (1) the association between baseline TZD use and the incidence of vascular dementia among people with T2DM and (2) how changes in antidiabetic treatments and their dose over time (e.g., TZDs and metformin) associated with subsequent risk of vascular dementia in T2DM.
Methods: We will perform a retrospective cohort study using the UK CPRD Aurum database. This project will include adults (ageâ¥18 years) with a new onset T2DM without dementia between 01/01/2003 and 31/12/2023. The primary outcome will be incident vascular dementia, with secondary outcomes being mixed dementia and Alzheimer's disease. We will analyse objective (1) using flexible parametric survival models that account for competing events (e.g., death obtained from linked data), preventing vascular dementia from onset. We will subsequently assess medications every six months and analyse objective (2) using a landmark model. This original work will provide more robust evidence of the link between TZD use and the risk of vascular dementia.
Expected outcome: We will build a fundamental theoretical knowledge underpinning the development of drug repurposing, which may foster cost-effective and fast-track drug development. The evidence may support further randomised clinical trials testing the clinical and cost-effectiveness of TZD on cognitive and/or vascular dementia outcomes in people with T2DM.
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Cardiovascular Risk of Menopausal Hormone Therapy in Women with Diabetes: A Cohort Study — Ruth Brauer ...
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Cardiovascular Risk of Menopausal Hormone Therapy in Women with Diabetes: A Cohort Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; CPRD Aurum Ethnicity Record; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-15
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Hindun Risni - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )Outcomes:
Venous thromboembolism (VTE); Myocardial infarction (MI); Stroke
Description: Lay Summary
Diabetes is a condition where our body has trouble controlling blood sugar levels, resulting in high blood sugar. High blood sugar increases the risk of stroke, heart attack, and clots in blood vessels. These problems are often called cardiovascular disease (CVD). In women, the risk of CVD further increases during and after menopause. Menopausal Hormone Therapy (MHT) is commonly used to treat menopausal symptoms. We know that the use of MHT can increase the risk of CVD in the general population, but we do not know if MHT increases the risk of CVD even more in women with diabetes. We plan a study to find out if MHT changes the risk of CVD in women who were diagnosed with diabetes between 2004 and 2024. We will look for the medical records of all women aged between 40 and 65 years with a diagnosis of diabetes. This will be our study population. Next, we will divide the study population into two groups: those who took MHT and those who did not. Then, we will compare the risk of heart attack, stroke, and blood clot in each group. We will use Clinical Practice Research Datalink (CPRD) medical information that has been anonymised before being made available for research. Our study results will inform women with diabetes about the long-term effects of MHT, allowing them to make informed choices about treatment options for menopausal symptoms.
Technical SummaryApproximately two million women in the UK are affected by diabetes, with 44% of diagnoses occurring during midlife (40-65 years). Diabetes increases the risk of cardiovascular disease (CVD), and this risk further increases for women during and after menopause. Small clinical studies suggest that the use of Menopausal Hormone Therapy (MHT) may mitigate the potential excess risk of CVD in women with diabetes. There is a lack of large population-based studies that have investigated the risk of CVD in menopausal women with diabetes prescribed MHT. Our objectives are to 1) describe the prescribing rate of MHT in women with diabetes by type and treatment of diabetes, age, ethnicity, and Body Mass Index (BMI) and 2) assess the risk of CVD (VTE, MI and stroke) in women with diabetes who are prescribed MHT.
We will use data from CPRD to establish a cohort of women (40-65 years), diagnosed with diabetes and with CPRD follow-up time between 2004 and 2024. Women in receipt of prescriptions for MHT will be our exposed population. We will select a subset of women with 'non-exposed' follow-up time from the study cohort and use exposure density sampling (EDS) to assign a random index date for the comparison group (non-users). A Cox regression model will be used to compare the incidence of outcomes between MHT ever-users and non-users. Our analyses will be run separately by type of diabetes and MHT treatment and take into account factors that may influence our results, such as age, BMI, and ethnicity. Propensity scores will be used to control for potential confounding, and several sensitivity analyses will be performed to assess the robustness of our results.
Our study results will contribute to evidence-based MHT prescribing for menopausal symptoms in women with diabetes.
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A study to characterise the burden of illness among patients with chronic obstructive respiratory disease with eosinophilic phenotype who frequently exacerbate: An analysis of English linked primary and secondary care data — Jihye Park ...
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A study to characterise the burden of illness among patients with chronic obstructive respiratory disease with eosinophilic phenotype who frequently exacerbate: An analysis of English linked primary and secondary care data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-29
Organisations:
Jihye Park - Chief Investigator - GlaxoSmithKline LLC (USA)
Poppy Payne - Corresponding Applicant - Adelphi Real World
James Bolaji - Collaborator - GlaxoSmithKline - UK
Jennifer Quint - Collaborator - Imperial College London
Olivia Massey - Collaborator - Adelphi Real World
Shibing Yang - Collaborator - GSK
Theo Tritton - Collaborator - Adelphi Real World
Will Kay - Collaborator - Adelphi Real WorldOutcomes:
Acute exacerbations of COPD (AECOPD); Mortality; Healthcare Resource Use (HCRU) and associated direct healthcare costs; BEC testing status.
Description: Lay Summary
Chronic obstructive pulmonary disorder (COPD) is a common preventable lung disease, often caused by air pollution or smoking. The disease can limit airflow through the lungs, causing symptoms such as coughing, shortness of breath, wheezing, and chest tightness. COPD was the third highest cause of death in England and Wales in 2022.
The bodyâs immune system responds to COPD by producing white blood cells called eosinophils. Some evidence suggests that patients with a high amount of eosinophils are more likely to experience more severe symptom flare-ups.Treatment is personal for each patient depending on the progression of COPD. Patients are given maintenance therapy to help keep airways open and prevent symptom flare-ups. Patients who commonly have symptom flare-ups are recommended inhalers which combine two types of drug called dual therapy inhalers, or, if dual therapy inhalers do not control symptoms, they are recommended inhalers which combine three types of drug, called triple therapy inhalers. In the UK, patients receiving triple therapy inhalers for COPD who still experience symptom flare-ups have few further options to control their COPD, while no treatments aim to reduce eosinophil levels.
Due to some remaining questions in research on the role of eosinophils in COPD presentation and the lack of treatment options for patients on maximum strength therapy, it is important to understand the impact of eosinophil levels on symptom flare ups, to help manage COPD patient care in England.
Technical SummaryAim: To describe the disease burden and healthcare resource utilisation (HCRU) among patients aged â¥35 years in England diagnosed with COPD who exacerbate frequently, stratified by blood eosinophil count (BEC).
Objectives: Among patients with COPD who are frequent exacerbators, to: i) describe disease burden and health outcomes among patients on triple therapy, overall and by baseline BEC; ii) examine the baseline sociodemographic and clinical predictors of BEC testing status among patients on triple therapy; iii) examine the impact of BEC on health or disease burden outcomes among patients on triple therapy; and iv) describe sociodemographic, clinical and treatment characteristics among patients on: a) triple therapy, b) ICS/LABA, c) LAMA/LABA, and d) triple therapy who are former smokers, overall and by baseline BEC.
Methods: Retrospective analysis of longitudinal healthcare data in England utilising linked primary and secondary care data from Clinical Practice Research Datalink (CPRD) Aurum and Hospital Episode Statistics (HES) datasets, respectively.
Index criteria: The most recent moderate/severe exacerbation of COPD (AECOPD) (â¥1 moderate/severe AECOPD in the year prior if the most recent AECOPD was moderate).
Covariates: Index year; baseline sociodemographic and clinical characteristics (age, gender, region, ethnicity, deprivation, body mass index (BMI), forced expiratory volume, smoking status, Charlson Comorbidity Index (CCI), MRC dyspnoea score); baseline all-cause primary and secondary care HCRU events; baseline respiratory therapies.Outcomes: AECOPD; Mortality; HCRU and associated direct healthcare costs; BEC testing status; sociodemographic and clinical characteristics.
Data analysis: For descriptive analysis, counts, means, medians, standard deviation (SD), 25th and 75th percentile values will be reported for continuous variables, with relative frequencies and proportions/percentages for categorical variables. For inferential analyses, i) a multivariate logistic regression will examine predictors of BEC testing status, and ii) appropriate regression models and a PS weighting method will evaluate the impact of BEC on disease and clinical outcomes.
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Patterns of anti-depressant prescribing in inflammatory bowel disease — Matthew Cohen ...
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Patterns of anti-depressant prescribing in inflammatory bowel disease
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-20
Organisations:
Matthew Cohen - Chief Investigator - King's College London (KCL)
Matthew Cohen - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Calum Moulton - Collaborator - King's College London (KCL)
Khalida Ismail - Collaborator - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)Outcomes:
Primary outcomes include the incidence of depression and anxiety events in patients with pre-existing inflammatory bowel disease (IBD); the percentage of anti-depressant treatment episodes that are the minimum recommended duration (7 months); the patterns of treatment continuation and/or discontinuation.
Secondary outcomes include healthcare utilisation (e.g. hospital admission, primary care consultations), IBD progression and self-harm and suicide events
Description: Lay Summary
Inflammatory bowel disease (IBD) including Crohnâs disease (CD) and Ulcerative colitis (UC) is a chronic condition with no permanent cure. In the UK the rates of new onset IBD are rising with lifetime healthcare costs comparable to those associated with heart disease and cancer. Patients with IBD are at a higher risk of developing depression and anxiety compared to individuals without IBD. Depression and anxiety in IBD may be caused by psychological factors associated to the disease or shared biological mechanisms. The presence of depression and anxiety in IBD associates to several poor outcomes including higher rates of hospitalisation, more frequent relapses, and higher rates of surgery.
While anti-depressants could mitigate the increased risk of these outcomes, recent research has shown that most individuals with IBD end anti-depressant treatment early, meaning psychiatric symptoms may not be fully treated and could relapse. Early discontinuation of anti-depressants in patients with IBD may be reflect their differing efficacy and tolerability in these individuals compared to those without IBD. As IBD can affect the absorption of anti-depressants and increase sensitivity to side effects, certain anti-depressants may be preferred for individuals with IBD.
This research will use primary care data to explore if anti-depressant treatment courses differ in length between patients with and without IBD, and if there are certain anti-depressants patients with IBD can take for the recommended duration. Findings will help inform guidelines and future trials aimed at discovering which are the best anti-depressants for patients with depression and/or anxiety alongside IBD.
Technical SummaryBackground: Depression and anxiety are prevalent in inflammatory bowel disease (IBD) and associate to a poor prognosis including higher rates of hospitalisation, more frequent relapses, and more surgical interventions. While anti-depressants may mitigate these outcomes, recent research has shown that most patients with IBD do not complete a full anti-depressant course (6-9 months after the cessation of symptoms). Early anti-depressant discontinuation may mean psychiatric symptoms are not fully treated and an increased relapse risk. As patients with IBD may absorb anti-depressants differently to those without IBD, and be more sensitive to side effects, certain anti-depressants may be more effective and better tolerated for this cohort.
Aims: This study will assess if anti-depressant treatment durations differs in patients with IBD compared to patients without IBD, and if so which anti-depressants can patients with IBD take for the full treatment duration. The study aims to also explore how clinical and demographic factors impact on the duration of anti-depressant treatment in patients with IBD, and compare the incidence of adverse mental health and anti-depressant outcomes across IBD and non-IBD groups.
Methods: The study is a matched retrospective cohort using cox proportional hazard regression analysis with duration of anti-depressant treatment as an outcome and IBD as an exposure. Multivariate survival analyses will assess how gender, age, IBD type, IBD severity and symptom profile affect treatment duration. Cox proportional hazard regression analysis will be conducted to explore if treatment duration differs across specific anti-depressants or anti-depressant classes. Secondary analyses will compare the incidence anti-depressant related adverse events and mental health outcomes. This research will provide new insights on which anti-depressants are best tolerated for patients with IBD. This will provide a public health benefit by informing clinical guidelines and help patients with IBD and depression to take the full anti-depressant treatment course.
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A comparison of clinical outcomes in patients with asthma newly initiating Inhaled Corticosteroid (ICS) and Long-acting beta 2 agonist (LABA) Relvar and Symbicort combination inhalers in England. — Manish Verma ...
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A comparison of clinical outcomes in patients with asthma newly initiating Inhaled Corticosteroid (ICS) and Long-acting beta 2 agonist (LABA) Relvar and Symbicort combination inhalers in England.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-14
Organisations:
Manish Verma - Chief Investigator - GSK India Global Service Private Limited
Alexander Ford - Corresponding Applicant - Adelphi Real World
Arunangshu Biswas - Collaborator - GSK India Global Service Private Limited
Emily Vinall - Collaborator - Adelphi Real World
Ines Palomares - Collaborator - GSK
Neha Shah - Collaborator - GSK
Rosie Wild - Collaborator - Adelphi Real World
Sanchayita Sadhu - Collaborator - GSK
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Asthma exacerbations; medication use, adherence and persistence; dosage changes; healthcare resource utilisation (including GP visits, inpatient stays, outpatient visits, and emergency department visits)
Description: Lay Summary
Asthma is a common lung disease which causes breathing difficulties. It affects around 339 million individuals and causes approximately 461,000 deaths worldwide each year. Patients who have asthma may report chest tightness, wheezing, a cough and symptom flare-ups.
There are a range of drugs that are available for the treatment of asthma in the UK. To help prevent symptom flare-ups patients can be given inhaler treatments containing a combination of two types of drugs, taken together as part of a single inhaler. One type of this inhaler available to patients with asthma in the UK, includes a combination of inflammation preventing steroids (ICS) and long-acting drugs (LABA) which relax the airways; these inhalers are termed ICS/LABA inhalers. All ICS/LABA inhalers are intended to be used daily to prevent symptoms over an extended period of time. There are a range of ICS/LABA therapies available to patients with asthma in the UK, including fluticasone furoate/vilanterol (FF/VI) and budesonide/formoterol (BUD/FOR).
This study aims to compare the effectiveness of FF/VI and BUD/FOR inhalers by looking at how often patients using these therapies experience symptom flare-ups. We will also compare between people taking FF/VI or BUD/FOR inhalers the use of other asthma medication used to relieve symptom flare-ups, the use of healthcare services, and whether patients use their asthma medication according to treatment instructions. The results of this study can be used to better inform treatment decisions for people receiving care for asthma in the UK.
Technical SummaryAim: The aim of this comparative effectiveness research (CER) study is to compare the real-world effectiveness of fluticasone furoate/vilanterol (FF/VI) versus budesonide/formoterol (BUD/FOR) ICS/LABA therapies, among patients with asthma in a general practice cohort in England.
Objectives: To assess the comparative effectiveness of FF/VI and BUD/FOR using the following outcomes: rate of moderate or severe asthma exacerbations (primary objective), rate and time-to-first exacerbation for moderate and severe exacerbations, time-to-first exacerbation, asthma symptom control, healthcare resource utilisation, treatment use, persistence and adherence (secondary objectives). To describe seasonal trends in rate of moderate-to-severe exacerbations and time to ICS dose step-up from index.
Methods: A new-user, active comparator, retrospective cohort study using probability of treatment weighting (IPTW) to adjust for measured confounders will be employed using linked primary and secondary care data. Patients will be indexed on the first/earliest prescription of a single device FF/VI or BUD/FOR inhaler during 1st December 2015 to 28th February 2019, with a minimum of 12 months baseline and maximum of 12 months follow up available. A maximum of 12 months follow-up will be used to assess effectiveness outcomes.
Exposures: Patients with asthma in England newly initiating FF/VI or BUD/FOR ICS/LABA therapies. Respective dosage strata will be compared between treatment groups.
Outcomes: Asthma exacerbations, SABA use, healthcare use treatment patterns, medication use, persistence and adherence.
Data Analysis: IPTW will be implemented following propensity score (PS). Comparisons will be made on both weighted and unweighted treatment cohorts (those newly initiating different ICS/LABAs). Comparisons of rates will be made using rate ratios which will be calculated using a negative binomial model. Time-to-event comparisons will be made using a cox proportional hazards model. For comparisons treatment dose, and adherence and persistence. least squares and logistic regression models will be utilised, respectively. For regression models, 95% CIs and p-values will be generated.
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Association of Non alcoholic fatty liver disease (NAFLD) and adverse pregnancy outcomes — Krishnarajah Nirantharakumar ...
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Association of Non alcoholic fatty liver disease (NAFLD) and adverse pregnancy outcomes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Megha Singh - Corresponding Applicant - University of Birmingham
Jingya Wang - Collaborator - University of Birmingham
Katherine Phillips - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Steven Wambua - Collaborator - University of BirminghamOutcomes:
Outcomes to be Measured
1-Pregnancy complications (first trimester, second trimester mainly)
1. Miscarriage
2. Hyperemesis gravidarum
3. Ectopic pregnancy
4. Hypertensive disorders of Pregnancy (Gestational hypertension, Pre-eclampsia, Eclampsia, HELLP)
5. Gestational diabetes mellitus
6.Antenatal anxiety
7.Antenatal depression
8.Postpartum anxiety
9. Post-partum depression
10.Puerperal psychosisStudy 2-Obstetric outcomes
1. Obstetric haemorrhage (postpartum)
2. Mode of Birth Caesarean delivery (HES), Instrumental
3. Perineal trauma-3rd and 4th degree
4. Stillbirth
5. Placental abruption
6. Pre-term birth
7. Small/Large for gestational ageStudy 3-Adverse offspring outcomes
1. Major congenital abnormalities
2. Neurodevelopmental disordersDescription: Lay Summary
Non-alcoholic fatty liver disease (NAFLD) is a condition where extra fat builds up in the liver even if a person doesn't drink much alcohol. It is quite common, affecting about one in four people around the world. The number of cases is increasing because more people are becoming obese. In the UK, about 20-30% of adults have NAFLD, and it's also common among women who can have children.
NAFLD is particularly important to monitor during pregnancy because it can impact the health of both the mother and the baby. Research shows that pregnant women with NAFLD are more likely to develop diabetes, high blood pressure, and have babies who are born prematurely or smaller than usual. Studies have found that women with NAFLD are more likely to have these issues compared to women without NAFLD. This indicates that NAFLD can significantly affect pregnancy and needs careful management.
However, there is still much we don't know about NAFLD and its effects on pregnancy. Many studies have been small and may not represent everyone. We don't fully understand why NAFLD causes these problems during pregnancy or if different amounts of liver fat have different effects.This study aims to answer these questions by examining a large and diverse group of pregnant women. The goal is to improve health outcomes for both mothers and their babies by finding better ways to manage NAFLD during pregnancy.
Technical SummaryAims: The aim of this study is to investigate association of the presence of NAFLD at the start of pregnancy and adverse pregnancy outcomes.
Study will be divided into three parts.
Study 1- Using the CPRD Pregnancy Register, cohort of pregnancies will be established.. Will estimate the prevalence of NAFLD among pregnancies within the CPRD Pregnancy Register. Then compare the incidence of pregnancy complications in pregnancies with and without pre-existing NAFLD. Both NAFLD and pregnancy complications will be ascertained by diagnostic codes
Study 2-Using linked HES data, cohort of delivery records will be ascertained based on OPCS and ICD10 delivery codes. We will compare the incidence of obstetric complications in pregnancies with and without pre-pregnancy NAFLD. Obstetric complications will be ascertained by both primary care and linked HES records.
Study 3-Using mother-baby linked data, cohort of babies born and linked to mothers within the CPRD Pregnancy Register will be established. We will estimate the risk of offspring outcomes between pregnancies with and without pre-pregnancy NAFLD.
A matrix of odds ratio will be tabulated quantifying the association between NAFLD and pregnancy outcomes. Based on a series of logistic regression models and will be adjusted for relevant covariates.
Exposures: coded diagnosis of NAFLD
Participants: Women aged 15 to 49 years at the start of pregnancy
Covariates: Pregnant womenâs age, social deprivation, ethnicity, body mass index, smoking status, parity/gravidity, calendar year, and comorbidities will be considered as covariates for the studies.
Intended public health benefits:
With the increase in the prevalence of NAFLD in women it becomes pertinent to study the association with pregnancy.This study will ascertain potential association of NAFLD with pregnancy complications/adverse pregnancy outcomes and will help clinicians to develop appropriate strategies or suitable healthcare pathways to avoid the occurrence of these outcomes.
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Sex-specific effectiveness and safety of sacubitril-valsartan compared to angiotensin-converting enzyme inhibitors in heart failure; target trial emulation of the PARADIGM-HF trial — Sophie Bots ...
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Sex-specific effectiveness and safety of sacubitril-valsartan compared to angiotensin-converting enzyme inhibitors in heart failure; target trial emulation of the PARADIGM-HF trial
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-22
Organisations:
Sophie Bots - Chief Investigator - Utrecht Institute for Pharmaceutical Sciences
Patrick Souverein - Corresponding Applicant - Utrecht University
Daniala Weir - Collaborator - Utrecht University
Vasiliki Panagiota Tassopoulou - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes:
Effectiveness outcomes of interest: heart failure hospitalisation; all-cause-mortality
Safety outcomes of interest: hypotension; elevated serum creatinine; hyperkalaemia; cough; angioedema; renal impairment
Description: Lay Summary
Healthcare problem
Women treated with heart medications have twice the risk of side effects compared with men. This is especially pressing for women with heart failure, because this condition predisposes them to side effects. Literature suggests that sex-specific treatment may reduce the risk of side effects, as they could be related to biological differences in how women's and men's bodies handle medications.
Knowledge gap
Women have been underrepresented in heart failure trials, and many trials do not report their findings by sex. This makes it difficult to detect differences in the number and type of side effects women and men experience, and to understand why these differences occur.
Aim of this proposal
We aim to repeat a major heart failure study in a real-world setting using a new, innovative method. This has two main benefits:
It includes patients who use heart medications in their everyday lives, ensuring women with heart failure are properly represented. The method applies strict quality checks on observational studies, ensuring the results meet high standards and can be used in treatment guidelines.Expected public health benefits
Serious side effects from treatment can cause hospitalization or even death, greatly affecting a patient's life. Even milder side effects like nausea can cause patients to stop their treatment, which can worsen their condition over time. By tailoring treatment based on sex, we can reduce these risks, improving health for individuals and reducing the overall impact on society.
Technical SummaryBackground
Although observational research suggests that women treated with cardiovascular medications have twice the risk of adverse drug events (ADEs) compared with men, this knowledge has yet to be incorporated in practice. Main barriers are the (perceived) low quality of the observational evidence compared to clinical trial data and the lack of relevant and easy-to-interpret benefit-harm comparisons for clinicians and patients.Aims/objectives
(1) Strengthen the evidence base using the target trial emulation framework to translate the PARADIGM-HF trial findings to a real-world population with proper representation of women.Study population
Women and men with HF who receive either the exposure of interest (sacubitril/valsartan) or the comparator medication (any angiotensin-converting enzyme inhibitor, ACEI). Following the in-/exclusion criteria from the PARADIGM-HF trial, this only comprises patients with HF with reduced Ejection Fraction (HFrEF).Primary exposure(s) and outcome(s)
Primary exposure is sacubitril/valsartan, with ACEIs as the active comparator.
Primary outcomes are split into effectiveness (HF hospitalisation and all-cause mortality) and safety (hypotension, renal dysfunction, hyperkalaemia, angioedema, cough) outcomes.Data sources
We will use CPRD Aurum, linked to Hospital Episode Statistics (HES) to determine HF diagnosis and hospitalisations.Study design and methods
We will follow the target trial emulation framework, using the active-comparator prevalent-user design, as this most accurately emulates the target trial in question. Confounding will be addressed through propensity score methods. We will use Cox proportional hazard models for both effectiveness and safety outcomes.Intended public health benefit
Reducing the risk of ADEs by tailoring HF treatment to sex leads to better short- and long-term outcomes, which decreases disease burden both on the individual and the societal level
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Influence of Attention-deficit hyperactivity disorder (ADHD) on type 2 diabetes medication persistence — Kenneth Man ...
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Influence of Attention-deficit hyperactivity disorder (ADHD) on type 2 diabetes medication persistence
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Siu Chung Andrew Yuen - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - University College London ( UCL )Outcomes:
Primary outcome:
First antidiabetic drugs discontinuation: It will be defined as a gap of more than 45 days between consecutive prescriptions. Antidiabetic drugs are defined as ATC code: A10A and A10B in the primary analysis.Secondary outcome:
Proportion of days covered (PDC): PDC will be calculated by calculating the proportion of days in which a person has access to the antidiabetic medication over a given period of interest. PDC = (Sum of days covered by antidiabetic medication in time frame) ÷ (number of days in time frame) à 100%. PDC will be calculated over 1-, 2- and 5-years follow-up lengths after the first prescription start date. PDC < 80% will be defined as "poor persistence".1-4Description: Lay Summary
Attention deficit hyperactivity disorder is a condition that is characterised by difficulty in maintaining concentration and make it hard to manage daily tasks. It can also be related with a higher risk of developing diabetes, which is a condition where our body cannot manage its blood sugar level. Control of diabetes usually requires use of medications, but symptoms of attention deficit hyperactivity disorder can make sticking to the medication routine challenging. This study aims to explore how attention deficit hyperactivity disorder and its treatments impact people's ability to consistently take their blood sugar medications.
We will look at whether people with attention deficit hyperactivity disorder are more likely to stop taking their blood sugar medications compared to those without the condition. We will also see if attention deficit hyperactivity disorder medications can help patients stick to their blood sugar treatments better.
Using data from the Clinical Practice Research Datalink, we will analyse how long it takes for attention deficit hyperactivity disorder adult patients to stop their blood sugar medications and how regularly they take them over different periods.
Understanding these relationships can help doctors provide better support to patients with attention deficit hyperactivity disorder in managing their blood sugar, potentially leading to improved health outcomes. Given the common use of blood sugar medications and the growing awareness of attention deficit hyperactivity disorder, our findings could influence clinical practices and health policies worldwide, ultimately helping patients make more informed decisions about their treatments.
Technical SummaryAttention deficit hyperactivity disorder (ADHD) poses long-lasting and debilitating impact in various aspects of an individualâs life. In adulthood, the more overtly disruptive ADHD symptoms experienced in childhood often shift into more subtle symptoms such as inner restlessness, inattention, disorganisation, and difficulties in executive functioning. ADHD is also associated with a wide range of metabolic diseases, including type 2 diabetes (T2D).
This study aims to evaluate the impact of ADHD and ADHD medication on adherence to antidiabetic medications. Blood glucose management critically depends on medication adherence, yet individuals with ADHD may struggle, potentially leading to poorer outcomes.
We will employ a population-based cohort design using data from the Clinical Practice Research Datalink (CPRD). Our study will include adults aged 18 or above who initiated antidiabetic medications between 1st January, 2001 and 31st December, 2020.
The primary objective is to assess the association between ADHD and the time to first discontinuation of antidiabetic medication. We will also evaluate the persistence of antidiabetic medication, measured by the proportion of days covered (PDC) over 1-, 2-, and 5-year follow-up periods, with PDC < 80% defined as "poor persistence". Additionally, we will investigate the impact of ADHD medication on antidiabetic medication persistence in individuals with ADHD.
We will use Cox regression to estimate hazard ratios (HRs) for the time to first discontinuation, and logistic regression to analyse patients with PDC defined as âpoor persistenceâ, adjusting for relevant covariates such as age, sex, ethnicity, other cardiometabolic medications and conditions, and comorbid psychiatric conditions. Subgroup and sensitivity analyses will be conducted to provide a comprehensive understanding of the relationships between ADHD, ADHD medication, and antidiabetic medication adherence.
This research will provide insights into how ADHD impact the management of T2D, potentially informing targeted interventions to improve overall clinical outcomes in patients prescribed with antidiabetic medications.
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Characterising the inter-relationships between multiple long-term conditions and polypharmacy across diverse UK populations using artificial intelligence — Nick Reynolds ...
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Characterising the inter-relationships between multiple long-term conditions and polypharmacy across diverse UK populations using artificial intelligence
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Nick Reynolds - Chief Investigator - Newcastle University
Dexter Canoy - Corresponding Applicant - Newcastle University
Barbara Hanratty - Collaborator - Newcastle University
Ellen Moss - Collaborator - Newcastle University
John Casement - Collaborator - Newcastle University
Liyuan Zhu - Collaborator - Newcastle University
Michael Barnes - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Paolo Missier - Collaborator - Newcastle University
Rebeen Hamad - Collaborator - Newcastle University
Shaun Hiu - Collaborator - Newcastle University
Wasim Iqbal - Collaborator - Newcastle UniversityOutcomes:
⢠For identifying data-driven patterns (clustering and trajectories) of MLTC-M-PP: diagnoses, prescriptions, demographic factors and deprivation level (these are not 'outcomes' but variables to be used for discovering clustering patterns and trajectories).
⢠For determining impact of the derived MLTC-M-PP clustering and trajectories on health outcomes: all-cause and cause-specific mortality; disease clusters (e.g., subsequent MLTC-M arising from 'baseline' MLTC-M); health service utilisation (e.g., frequency of general practice clinic visits, frequency and duration of unplanned hospitalisation and/or readmission)
Description: Lay Summary
Many people live with two or more, or multiple, long-term health conditions (MLTC), such as cancer, heart disease, inflamed joints and mental health problems. People living with MLTC may progress to poor health and have a shorter life expectancy. Treating multiple health conditions require a balancing act. Often, they are prescribed many different medicines together (known as âpolypharmacyâ). Sometimes, these medicines can interact in unexpected ways, which can lead to adverse effects and cause further health problems. Our study aims to improve our understanding of the inter-relationships between MLTC, polypharmacy, personal and social factors to help optimise treatment for individual patients. We apply new developments in computer technology called âartificial intelligenceâ (AI) to develop methods to analyse healthcare data collected from GP practices and hospitals from different regions across the UK to find out how long-term health conditions and polypharmacy change and interact over time, and how these patterns relate to personal and social as well as future health outcomes. These data are anonymised, large, and complex, but AI is very good at spotting patterns in these kinds of data. We will apply AI to look for patterns and trends on the interrelationships among long-term health conditions, prescribed medicines, personal/social factors and level of deprivation. In the long term, our research will lead to strategies for improved management of MLTC including targeted review of medicines.
Technical SummaryMultiple long-term conditions (multimorbidity)(MLTC-M) is associated with premature mortality, significant treatment burden, and increased health care and socioeconomic costs. Deprivation contributes to its early onset while inequalities exacerbate it. Polypharmacy is associated with MLTC-M but the interrelationship is complex and its impact on health outcomes is poorly understood. Moreover, analysing these associations will require methods that can handle the size and complexity particularly of data extracted from large-scale electronic health records (EHR). We aim characterise the relationship between MLTC-M clusters and polypharmacy (MLTC-M-PP) and describe how MLTC-M-PP relates to inequalities and health outcomes using cutting-edge methodologies in data analytics. In this proposed study we aim to:
1. Develop novel and refine existing advanced statistical methods and artificial intelligence (AI) techniques to characterise MLTC-M and polypharmacy clusters and trajectories identified from large-scale EHR
2. Describe the associations of MLTC-M and polypharmacy, its impact on health outcomes, and how these associations vary by demographic factors and deprivation level
3. Describe how the interrelationship between MLTC-M and polypharmacy could inform risk stratification across demographic factors and deprivation level
We will apply AI techniques and explore using other advanced methodologies, including bursty dynamics theory from complex systems research, to characterise healthcare event structure, association rules mining to illuminate event sequence, topological data analysis, and market-basket analysis with topic modelling to define latent associated conditions. Quantitative methods will be optimised using CPRD resource, with particular focus on intersectional contrasts, such as by age groups, sex, ethnicity and deprivation levels.
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Describing the prescribing trends of drug classes which may produce dependency: gabapentinoids, benzodiazepines and Z-drugs. — Sophie Scanlon ...
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Describing the prescribing trends of drug classes which may produce dependency: gabapentinoids, benzodiazepines and Z-drugs.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-14
Organisations:
Sophie Scanlon - Chief Investigator - MHRA
Sophie Scanlon - Corresponding Applicant - MHRA
Katherine Donegan - Collaborator - MHRAOutcomes:
Primary outcomes: prevalence and incidence of patients prescribed gabapentinoids, benzodiazepines and Z-drugs; descriptive measures of treatment duration; descriptive measures of treatment dose.
Secondary outcomes: treatment indication; line of treatment.Description: Lay Summary
Some prescription medicines can be addictive and could cause problems for people taking them or coming off them. However, many people benefit from these medicines that are used to treat problems like pain, anxiety, and insomnia, and so it is important to support their safe use. This study will describe the use of three classes of medicines; gabapentinoids, benzodiazepines and Z-drugs, which can produce dependence. The purpose of the study is to provide evidence as part of a review of these drugs, the aim of which is to guide regulatory action to ensure their safe and effective use.
Technical SummaryMany people benefit from medicines that treat problems like pain, anxiety, and insomnia, however some of these medicines are highly addictive and result in dependence and withdrawal issues. In September 2019, Public Health England (PHE) published a report looking at dependency in which they recommended that âbuilding on its review of opioids, the Commission on Human Medicines (CHM) considers evidence and guidance on the labelling of other medicines that may cause dependence or withdrawalâ. The purpose of this descriptive study is to help inform the MHRA and Commission on Human Medicines (CHM) response to the PHE dependency review, by providing baseline data on the use of these drugs within primary care. Ultimately with the aim to reduce the number of adverse drug reactions (ADRs) related to dependency with these drugs and support their safe use.
The study population will comprise all acceptable patients in CPRD AURUM, aged 16 and over, with at least one prescription for one of the drugs under study issued between 01/01/2014 and 31/03/2024. The exposure will be a prescription for any drug within three classes: gabapentinoids, benzodiazepines and Z-drugs. Overall (prevalence) and new-user (incidence) prescribing rates over time will be calculated and summary measures will be used to describe duration of treatment and dose at a population level. Following this initial analysis a more exploratory analysis will be carried out for selected drugs within the classes under study. This analysis will aim to describe treatment indication and line of treatment. The drugs for this secondary analysis will be chosen based on prior knowledge, including expert recommendation, and on usage identified in the primary analysis. Analyses will be stratified by sex and age-groups.
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Feasibility study to assess the numbers of patients with a blood test indicating an anaemia diagnosis in a single year — Winok Lapidaire ...
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Feasibility study to assess the numbers of patients with a blood test indicating an anaemia diagnosis in a single year
Datasets:GP data, CPRD Aurum Pregnancy Register; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-07
Organisations:
Winok Lapidaire - Chief Investigator - University of Oxford
Winok Lapidaire - Corresponding Applicant - University of Oxford
Amber Thorington - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Elliot Bentine - Collaborator - University of Oxford
Innocent Erone - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of OxfordOutcomes:
Anaemia; low iron; iron deficiency; low haemoglobin; B12 blood test, folate blood test,
Age; Sex; pregnancy status;
B12 supplements; iron supplements; iron tablets; iron infusions; iron prescription; folic acid; B12 injection.
Tiredness; weakness; headaches; shortness of breath; heart palpitations and paleness.Description: Lay Summary
The aim of this study is to determine the feasibility of conducting a study to test the performance of a non-invasive device that detects anaemia, a condition characterised by a lack of healthy red blood cells, compared to the current method of a blood test. This feasibility study will help us determine the number of patients who suffer from anaemia and the number of patients who have a blood test that results in a diagnosis of anaemia, in a single year. To find out whether patients have anaemia, we will look at relevant symptoms, follow-up tests and treatments, a medical record of anaemia, and the timing of diagnosed anaemia relative to the blood test. We will investigate whether anaemia is more common in people of a certain age, sex and pregnancy status. This will help us determine the feasibility of a future study to test a non-invasive, easy-to-use anaemia diagnostic device. It will also let us know in which healthcare setting and in which patient population we can find most people . This device could help improve diagnosis of anaemia, enable point-of-care anaemia diagnosis in community settings, and save time and money on anaemia blood tests.
Technical SummaryThe aim of this feasibility study is to assess the number and proportion of patients who have anaemia in a single year. We will find these patients by looking for a diagnosis for anaemia in primary care data or secondary care admission data, blood test results indicating anaemia (full blood count â haemoglobin, ferritin, serum iron, transferrin, transferrin saturation, soluble transferrin receptor, vitamin B12 and folate blood levels), anaemia treatments (prescriptions for iron, folic acid, or vitamin B12 supplements, and vitamin B12 injections), and related signs and symptoms (tiredness, weakness, headaches, shortness of breath, heart palpitations, or paleness). We will also stratify these results by the time between an anaemia diagnosis and the blood test to ensure the blood test is related to the diagnosis. We will stratify these results by patients demographics (age and sex), and pregnancy status (via the CPRD Pregnancy Register). The code lists based on structured clinical vocabulary for use in an electronic health records (Systematized Nomenclature of Medicine Clinical Terms - SNOMED CT, Broad Read, and (International Classification of Diseases 10th Revision - ICD10) will be developed by the applicants.
Understanding the prevalence of anaemia will help inform the feasibility and the target population, and target setting for a study testing the performance of anaemia diagnosis compared to the current method of a blood test. This device has the potential to facilitate diagnosis of anaemia by enabling point-of-care anaemia diagnosis in community settings, and save time and money on anaemia blood tests.
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An observational study describing the characteristics, management and outcomes of patients with hypertension not adequately controlled on current treatment in the UK — Benjamin Heywood ...
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An observational study describing the characteristics, management and outcomes of patients with hypertension not adequately controlled on current treatment in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-01
Organisations:
Benjamin Heywood - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Jil Billy Mamza - Collaborator - AstraZeneca Ltd - UK Headquarters
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK Headquarters
Ysabelle Boo - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
Prevalence of hypertension (HTN); uncontrolled HTN; controlled HTN; patient characteristics (demographic and clinical); medication use, adherence, persistence, adverse events; cardiorenal events, vascular events, mortality, change in clinical characteristics indicating disease progression; hospitalizations; outpatient contacts; number of medications; healthcare costs
Description: Lay Summary
High blood pressure, known as hypertension, is a key risk factor for a range of conditions including heart attacks, strokes, chronic kidney disease, metabolic diseases and premature death. Approximately one third of adults worldwide have hypertension. Despite improvements in the treatment, only 40% of people are reported to have the condition under control in the United Kingdom and some patients may have uncontrolled blood pressure despite being on optimum treatment defined as taking three different types of blood pressure lowering treatments. Under-treatment of hypertension may lead to unnecessary cardiovascular events. The aim of the study is to describe the patterns and frequency of hypertension, healthcare resource utilisation, the health outcomes and death rates of patients with hypertension within the UK, including those with existing kidney disease. Furthermore, the study aims to understand the factors associated with the cause of hypertension, and to investigate the progression of the disease.
Technical Summary
The early recognition and implementation of effective management strategies for uncontrolled blood pressure is vital to reduce the public health, economic and social burdens resulting from high treatment costs and associated disability and premature death.The global prevalence of hypertension (HTN) is estimated at approximately 30%. Despite advances in the treatment of HTN, only 40% of people have it under control in the United Kingdom. Uncontrolled HTN is a result of both patient- and physician-related factors, however, patients can remain uncontrolled despite being treated optimally (treatment resistant hypertension; TRH). Patients with uncontrolled HTN and TRH have higher risk of adverse cardiorenal outcomes and death. The aim of this study is to describe the epidemiology, patient characteristics, treatment patterns, health care resource utilization (HCRU), health outcomes and mortality of patients with HTN, including those with comorbid kidney disease. The objectives include 1) prevalence and incidence of hypertension; 2) describe demographic and clinical characteristics, drug utilization and treatment patterns; 3) describe the incidence and risk factors associated with adverse clinical outcomes and 4) assess the HCRU in routine clinical care for the defined domains/outcome variables, all across 3 HTN populations (overall HTN, treated HTN -controlled and uncontrolled). The outcomes to be measured include prevalence, patient characteristics and medication use across the 3 HTN populations, as well as cardiorenal events, vascular events, mortality, change in clinical characteristics indicating disease progression, hospitalisations, outpatient contacts, number of medications and healthcare costs. CPRD Aurum linked to Hospital Episode Statistics (HES) will be used to determine primary care contacts and prescriptions (CPRD Aurum) and secondary care contacts and associated costs (HES). ONS death data will also be used for mortality analysis. Descriptive statistics will be produced to describe the study population at baseline and HCRU. Understanding the health outcomes and mortality within this population will facilitate an improved understanding for earlier recognition and more optimised treatment which may reduce the risk of adverse events and death within this population in the UK.
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Effects of Discontinuation and Tapering of Antipsychotics in Older Adults Living with Dementia Using the Target Trial Emulation Framework — Wallis Lau ...
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Effects of Discontinuation and Tapering of Antipsychotics in Older Adults Living with Dementia Using the Target Trial Emulation Framework
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-23
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Olivia Bryant - Corresponding Applicant - University College London ( UCL )
Jan Chobanov - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )Outcomes:
1. All-cause mortality â identified using primary care records and Office for National Statistics death records. The study will consider the risk of death in the year following treatment allocation.
2. Stroke â identified using Hospital Episode Statistics and primary care records.
3. Osteoporotic fracture (hip, limbs, spine, pelvis) â identified using Hospital Episodes Statistics and primary care records.
4. Hospitalisation â identified using Hospital Episodes Statistics. The study will be considering risk of hospitalisation in the year following treatment allocation.
5. Pneumonia â identified using Hospital Episode Statistics.These trials will be repeated to look at the risk of these outcomes after 12 weeks, 24 weeks, and 1 year of continuous antipsychotics use.
Description: Lay Summary
Dementia covers multiple diseases that reduce brain function beyond what is typically expected with ageing, affecting memory and the ability to perform daily tasks. Most people living with dementia experience behavioural and psychological symptoms of dementia (BPSD) such as distress, hallucinations, agitation, and aggression. Antipsychotics are often used to treat hallucinations, delusions, or disordered thinking and therefore, are often used to ease BPSD.
However, while there is some evidence that the use of antipsychotics can lead to modest improvements in BPSD, many studies have raised safety concerns. Studies have found that antipsychotic use by those with dementia has been associated with increase of adverse outcomes such as cardiovascular events, hospitalisation, stroke, and pneumonia. Therefore, guidance states that antipsychotics should only be used by those with dementia in cases of extreme distress, should be short term with regular medication reviews, and should be tapered when a decision is made to discontinue.
Among those who use antipsychotics for mental health conditions, many have reported withdrawal effects, some severe, when discontinuing. The impact of discontinuing antipsychotics use in those living with dementiaâespecially on safety outcomes such as stroke, death, and hospitalisationâis unknown. This study aims to investigate the safety implications of tapering, abruptly discontinuing, or continuing antipsychotics after varying lengths of treatment duration on risk of death, hospitalisation, stroke, fracture, and pneumonia. As antipsychotic use remains high in the population with dementia, this study may give insights into the safety implications of current guidance and may help better inform clinicians when considering discontinuation.
Technical SummaryDespite safety concerns, antipsychotic use by those living with dementia remains high. Many studies have concluded that often the harms associated with antipsychotics outweigh the benefits for those living with dementia. Clinical guidance states that antipsychotics should only be used in cases of extreme distress, for short periods of time and discontinued within 12 weeks. When discontinuing, it is recommended that the dose is reduced 25-50% every 1-2 weeks, depending on the initial dose. It is unknown what the safety implications of discontinuing antipsychotics are for those living with dementia. This study will provide insights into the safety concerns associated with current guidance to taper and discontinue antipsychotics.
We will investigate the risk of death, hospitalisation, stroke, fracture, and pneumonia after tapering, abruptly discontinuing, or continuing use after 12, 24, and 52 weeks of continuous antipsychotic treatment. Patients will have a first diagnosis of dementia between 1st January 1998 and 31st March 2021 and aged 65+. Comparisons will be made between three treatment strategies: continuing treatment at a stable dose, tapering (reduction of at least 50% from baseline dose followed by discontinuation), and abrupt discontinuation (no treatment for >=28 days). The study has been designed using the target trial framework and separate trials will be run for each of the outcomes and each of the treatment durations. We will use the clone-censor-weight approach in the primary analysis and intention-to-treat in the secondary analysis. As patients those with dementia are often treated with antipsychotics multiple times, the main analysis will be a per-protocol analysis using marginal structural hazards models, approximated with pooled logistic regression. Weights will control for confounding and clones that do not adhere to the treatment strategy will be artificially censored. The models will output adjusted hazard ratios for each trial. Bootstrapping will be used to obtain confidence intervals.
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Does metformin reduce the incidence of carpal tunnel syndrome in patients with type 2 diabetes mellitus? — Dominic Furniss ...
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Does metformin reduce the incidence of carpal tunnel syndrome in patients with type 2 diabetes mellitus?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-01
Organisations:
Dominic Furniss - Chief Investigator - University of Oxford
Alexandra Wood - Corresponding Applicant - University of Oxford
Akira Wiberg - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Jennifer Lane - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
Outcomes will be defined as the first incident record within the CPRD database of either CTS diagnosis, steroid injection for CTS, or decompressive surgery for CTS following the commencement of either metformin or sulfonylureas. These outcome cohorts will be identified using OMOP Common Data Model codes, following the phenotyping processes approved by DARWIN EU, which are as follows:
1. Use codelistgenerator to identify the relevant codes
2. Two clinicians review the resulting list of codes
3. Run cohort diagnostics
4. Review cohort diagnostics and iterate this process if requiredCohort entry is at the index date as later defined (the date of initiation of metformin (target cohort) or sulfonylureas (comparator cohort) therapy with a diagnosis of Type 2 Diabetes Mellitus prior to or on the same date as the index event). Cohort exit occurs at the date of death or migration, date of outcome (as later defined as first event of either carpal tunnel syndrome; steroid injection for carpal tunnel syndrome; decompression surgery for carpal tunnel syndrome), or loss to follow up. Negative control outcomes will be used to identify potential residual confounding.
Description: Lay Summary
Carpal tunnel syndrome is a hand condition where compression of a nerve passing through the wrist causes pain, numbness and weakness in the hand. There are currently no effective drug treatments for the condition and it is often treated with an operation to free the compressed nerve. This does not work for one in four patients. Patients with diabetes, a condition where blood sugar is too high, are more likely to develop carpal tunnel syndrome.
Our previous research has found that high levels of a hormone called IGF-1 may contribute/lead to the nerve becoming compressed in carpal tunnel syndrome. Metformin, a common diabetes medication, reduces IGF-1 levels, so could potentially be used to prevent carpal tunnel syndrome.
We will use GP patient records to compare diabetic patients who take metformin to patients taking other medications for diabetes to see whether carpal tunnel syndrome is less likely to develop in the group of patients who take metformin.
If we find that taking metformin helps to stop patients developing carpal tunnel syndrome, then this would pave the way for a medical trial to see if taking metformin improves hand symptoms for people who already have carpal tunnel syndrome. If carpal tunnel syndrome can be treated with metformin, this could potentially avoid the need for surgery in thousands of patients, benefiting both them and the healthcare system more widely.
Technical Summary1. Objectives
We will compare the risk of CTS in patients with type 2 diabetes who are prescribed metformin (intervention) or sulfonylurea medications (comparator).2. Design
Cohort study using CPRD GOLD data mapped to the OHDSI Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). OMOP CDM is used with the intention of replicating the study in international datasets, enabling comparisons between different countries and therefore different populations.3. Participants
All patients with type 2 diabetes 18 years of age or older and new users of either metformin or sulfonylureas after at least 1 year of data visibility in CPRD GOLD.
Those with a history of either CTS diagnosis, steroid injection into the carpal tunnel for CTS or CTS decompression before they started their respective antidiabetic medications are excluded.4. Variables and measurements
The first recorded exposure to the drugs of interest will determine the drug exposure. Outcomes are defined as the first incidence of any outcome code as defined in the code list (see appendix) generated in the OMOP CDM using the Atlas tool. To minimise confounding, propensity score matching will be undertaken. Cox proportional hazards modelling will be used to produce an estimate of the hazard ratios for carpal tunnel syndrome in the users of each drug.5. Expected results
Hazard ratio of carpal tunnel syndrome at a population level associated with metformin treatment in comparison to sulfonylureas in adults with Type 2 Diabetes.
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Trends in the Prescription and Co-prescription of Central Nervous System Depressants in Patients with Chronic Obstructive Pulmonary Disease in United Kingdom Primary Care, 2000 - 2023 — Samy Suissa ...
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Trends in the Prescription and Co-prescription of Central Nervous System Depressants in Patients with Chronic Obstructive Pulmonary Disease in United Kingdom Primary Care, 2000 - 2023
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-01
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Corresponding Applicant - McGill University
Omotayo Olaoye - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill University
Sarah Beradid - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
First prescription of CNS depressants (opioids, benzodiazepines, z-drugs, and gabapentinoids) in patients with COPD, overall and by age, sex, UK nation, index of multiple deprivation (IMD), COPD severity, and the duration of pharmacological activity.
Baseline characteristics of patients newly prescribed of patients CNS depressants.
Prevalence of CNS depressant utilization overall and by age, sex, UK nation, index of multiple deprivation, COPD severity, and the duration of pharmacological activity.
Description: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that causes breathing problems. It is the third leading cause of death globally, accounting for about 3.2 million deaths yearly. COPD often coexists with other diseases which could significantly worsen the course of COPD and overall quality of life. Hence, patients with COPD may be prescribed several drugs to manage coexisting health conditions. Some of these drugs include some pain relievers and calming medications. Importantly, these drugs have the ability to slow down the activity of the brain and the body and may worsen breathing problems in patients with COPD. Although we know that the prescription patterns of these drugs in the general population have significantly changed over the past decade, we do not know how often these drugs are prescribed alone or together in patients with COPD. Therefore, we aim to describe patterns in which these drugs are prescribed alone or together in patients with COPD in the UK between 2000 and 2023. We will estimate the number of patients who started taking these drugs each year. We will also calculate the number of patients who are prescribed these medications alone or together compared to the overall number of patients with COPD per year. This study will inform physicians and public decision makers on the use these drugs over time in patients with COPD.
Technical SummaryCOPD is a chronic lung disease causing about 3.2 million deaths yearly. Patients with COPD often possess comorbidities which impact their prognosis and overall quality of life. The most common comorbidities include lung cancer, cardiovascular disease, metabolic diseases, musculoskeletal diseases, anxiety, depression, and chronic pain, affecting 32% to 60% of patients depending on COPD severity. These comorbidities may affect COPD treatment and necessitate the use of multiple medications including CNS depressants. CNS depressants such as opioids, sedative-hypnotics, and gabapentinoids are often prescribed for several indications, including chronic and neuropathic pain, anxiety, sleep disorders, and epilepsy. With increased awareness of the opioid epidemic and the availability of treatment alternatives, prescription patterns of CNS depressants in the general population have significantly evolved over the past decade. However, changes in prescription trends and the frequency of co-prescriptions of CNS depressants in patients with COPD remain unknown. Therefore, we aim to describe trends in CNS depressant prescribing and co-prescribing in patients with COPD between 2000 and 2023. First, we will assemble a cohort of all patients with COPD within this period. Next, we will estimate the annual rates and 95% confidence intervals (CIs) of patients newly prescribed each CNS depressant. We will also estimate age and sex-adjusted rate ratios and 95% CIs, comparing the annual rates of patients newly prescribed a CNS depressant to previous years using negative binomial models. Furthermore, we will estimate the annual proportion of patients prescribed and co-prescribed these medications. In secondary analyses, we will describe the baseline characteristics of patients receiving these medications over the past decade and conduct stratified analyses by age, sex, region, index of multiple deprivation, COPD severity, and the duration of pharmacological activity of these medications. This study will provide healthcare providers and policymakers with robust evidence to optimize medication use in patients with COPD.
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Investigating the utility of machine learning methods to predict prognosis and guide treatment decisions for people with lung cancer — Neal Navani ...
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Investigating the utility of machine learning methods to predict prognosis and guide treatment decisions for people with lung cancer
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-05
Organisations:
Neal Navani - Chief Investigator - University College London ( UCL )
Rebecca Giddings - Corresponding Applicant - University College London ( UCL )
James Bailey - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Menelaos Pavlou - Collaborator - University College London ( UCL )
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
Primary outcome;
Five year stage III lung cancer-specific mortalitySecondary outcomes
One year stage III lung cancer-specific mortality; Two year stage III lung cancer-specific mortality; One year mortality excluding deaths from lung cancer; Two year mortality excluding deaths from lung cancer; Five year mortality excluding deaths from lung cancer; GP attendances; hospital in-patient admissions; time spent in hospital, A&E visitsDescription: Lay Summary
Lung cancer is the leading cause of death from cancer worldwide. There are many different treatments available, and although research provides good evidence for treatment success across large groups of patients, it is very difficult to know what the best option is for each individual patient. To address this problem, machine learning (ML) (a type of artificial intelligence) has been used in other cancers, to guide what treatments would work best for different people.
Aims: Improve treatment decisions for lung cancer patients.
We will do this by:
o Understanding doctor and patient thoughts regarding healthcare tools developed using ML methods
o Developing an online tool that uses ML to accurately predict patient survival and quality of life following differing treatment courses.Methods
1. We will review previous research to understand how doctors and patients feel about the use of tools developed using ML methods
2. We will use data collected routinely for patients diagnosed with lung cancer across England and the US to develop and test this tool, using ML techniques.
3. We will ask physicians to complete a survey to investigate how tool use may alter their treatment recommendationsExpected patient benefits
Technical Summary
The research will develop a new decision support tool to help guide the discussion on treatment options for lung cancer.
By working with professionals and patients, we will start to think of how best to introduce these tools into medical practice to assist when making treatment decisions, with use potentially leading to a better chance of survival.Prognostic models enable clinicians to design tailored treatment regimes by estimating survival profiles specific to an individualsâ clinicopathological features. No such prognostic model is currently available for lung cancer patients, despite being the leading cause of death from cancer worldwide. Treatment decisions are also complex, particularly for patients diagnosed with Stage III Non-small cell lung cancer (NSCLC) due to the clinical equipoise regarding treatment options.
CPRD data offers a unique opportunity to develop prognostic models providing an estimate not only of survival but also anticipated quality of life dependent on treatment; identified as essential following PPI (patient and public involvement) consultation.Aim
Develop clinically informed prognostic models with the potential to improve decision making for Stage III NSCLC patientsObjectives
For Stage III NSCLC patients, utilise CPRD data to:
1. Develop prognostic models utilising variables known to impact survival, with estimates for lung cancer-specific mortality and mortality excluding deaths from lung cancer
2. Develop risk prediction models estimating outcomes which correlate to patient quality of life
3. Model the impact of treatments receivedMethods
We will use CPRD data to derive and validate prognostication models for stage III NSCLC patientsâ utilising statistical and machine learning (ML) methods. CPRD data will enable treatment effects to be modelled and also pertinent prognostic variables to be considered, such as co-morbidities and frequency of hospital admissions. It will allow outcomes such as symptom reporting and risk of GP/hospital visits following initiation of cancer treatment, which will inform quality of life impact.Impact
Model implementation has the potential to improve patient outcomes and reduce patient uncertainty around treatment decisions. Further, it will aid clinicians in recommending treatments and providing accurate prognostic predictions. To our knowledge, this is the first model to incorporate quality of life impact due to treatment, therefore advancing oncology prediction tools.
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A target trial emulation study assessing the mortality and morbidity risks of valproate withdrawal and developing a causal prediction model of the safest alternatives for young men and women with epilepsy — Gashirai Mbizvo ...
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A target trial emulation study assessing the mortality and morbidity risks of valproate withdrawal and developing a causal prediction model of the safest alternatives for young men and women with epilepsy
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-09
Organisations:
Gashirai Mbizvo - Chief Investigator - University of Liverpool
Gashirai Mbizvo - Corresponding Applicant - University of Liverpool
Anthony Marson - Collaborator - University of Liverpool
Glen Martin - Collaborator - University of Manchester
Gregory Lip - Collaborator - University of Liverpool
Hayley Jones - Collaborator - University of Liverpool
Iain Buchan - Collaborator - University of Liverpool
Laura Bonnett - Collaborator - University of Liverpool
Matthew Sperrin - Collaborator - University of Manchester
Pieta Schofield - Collaborator - University of Liverpool
Sneha Mary George - Collaborator - University of LiverpoolOutcomes:
The following literature-based outcomes will be assessed over 1-10 years following recruitment [1-5]:
âDeaths (all-cause/epilepsy-related);
âEmergency department (ED)/hospital admissions (all-cause/epilepsy-related);
âSeizures (symptom codes);
âFalls;
âInjuries;
âBurns;
âAspiration pneumonia;
âManic/bipolar episodes;
âNew-onset depression;
âSelf-harm/suicide;
âA composite morbidity index incorporating seizures, injuries, admissions, and depression.Description: Lay Summary
Valproate is a highly effective medication for controlling seizures. However, its use is restricted in women under 55 because it can harm their unborn child during pregnancy. Recent evidence indicates that valproate can also harm children born to men who take it, so these prescribing restrictions will soon apply to men under 55 as well. This means that many young men on valproate may soon be asked to discontinue it, similar to what happens for women. As valproate is such an effective antiseizure medication, stopping it could potentially harm some men or women.
To investigate this, we will conduct a study using anonymised health data that are already available. We will analyse data from men and women aged 16â54 who took valproate between 2014 and 2024 (group 1) and those who discontinued it, replacing it with either the medication lamotrigine (group 2), levetiracetam (group 3), or no new medication (group 4). Statistical methods will be used to balance background differences between these groups, such as age, type of epilepsy, and other health conditions. This will ensure fair comparisons can be made between the groups. We will then study data from the subsequent 1-10 years to see which groups had the highest risks of death, hospital admission, seizures, falls, injuries, burns, chest infections, depression, and self-harm/suicide. Finally, we will create a statistical tool to predict which alternative medications used to replace valproate are the safest.
This study will provide vital information on how to discontinue valproate safely for people with epilepsy.
Technical SummaryValproate is the most effective treatment for idiopathic generalised epilepsy. Currently, its use is restricted in women of childbearing potential owing to high teratogenicity. Recent evidence extended this risk to menâs offspring, prompting recommendations to restrict use in everybody aged
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Association between antibiotics use and encephalopathies-related hospitalization among people living with dementia- a self-controlled case series study — Li Wei ...
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Association between antibiotics use and encephalopathies-related hospitalization among people living with dementia- a self-controlled case series study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-01
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Chengsheng Ju - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Ubonphan Chaichana - Collaborator - University College London ( UCL )Outcomes:
Outcome event is the first hospitalization with an encephalopathies diagnosis that falls within the observation period which is identified by ICD-10 codes , Read codes and SNOMED CT codes.
HES A&E could be omitted.
We will identify the outcomes recorded in both CPRD primary care and HES Inpatient.Description: Lay Summary
Dementia is a disease that the brain function deteriorates over time. Both brain diseases (such as psychosis, seizure, and delirium) and infections are common in people living with dementia. Some classes of antibiotics are suspected to cause these brain diseases; however, some may reduce cognitive decline, which makes them potential good candidates for antibacterial treatment among people living with dementia. Nevertheless, complications of infections can also cause these brain diseases. There is an urgent need to understand the associations between infection, antibiotics and these brain diseases. This study aims to investigate the epidemiology of dementia and antibiotic use across United Kingdom, assess the risk of the brain diseases-related hospitalization rates among people with dementia and assess the risk among specific antibiotic drug class users. The study results have the potential impact on healthcare policy, clinical practice and patientâs health.
Technical SummaryBoth encephalopathies (presented as seizure, delirium or psychosis) and infections are common in people living with dementia. Some classes of antibiotics are suspected to cause encephalopathies. There is an urgent need to detangle the associations between infection, antibiotics and encephalopathies among people living with dementia. This studyâs first aim is to investigate the epidemiology of dementia and antibiotic use across United Kingdom. By using the study design of self-controlled case series (SCCS), this study assesses the risk of the encephalopathy-related hospitalization rate among people with dementia during periods of antibiotic exposure compared with periods of non-exposure; and assess the risk among specific antibiotic drug classes. Risk periods will be defined as follows: 8 to 14 days before antibiotics start (8â14 days pre- antibiotics), 1 to 7 days before antibiotics start (7 days pre- antibiotics), the antibiotics exposed period, 1 to 7 days after antibiotics completion (7 days post- antibiotics), and 8 to 28 days after antibiotics completion (8â28 days post- antibiotics). The pre-exposure period served to measure whether the occurrence of encephalopathy itself is temporarily associated with the probability of being prescribed an antibiotic.
The post-exposure period allowed us to determine whether any increased risk observed during antibiotics exposure would decline after antibiotics treatment is ceased. The study period is from Jan 1st 2002 to Dec 31st 2020. Conditional Poisson regression model will be used to estimate the incidence rate ratio and the 95% confidence interval. Seasonal effect will be adjusted in a 3-months band. Dementia patients aged 65 or above who have a hospitalization with an encephalopathies diagnosis and at least one prescription of antibiotics will be included in the SCCS analysis.
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Identifying which primary care activities are associated with reduced emergency hospital admissions towards the end of life, and for whom these activities are likely to be most effective: a retrospective cohort study — Katherine Sleeman ...
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Identifying which primary care activities are associated with reduced emergency hospital admissions towards the end of life, and for whom these activities are likely to be most effective: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-08-01
Organisations:
Katherine Sleeman - Chief Investigator - King's College London (KCL)
Emel Yorganci - Corresponding Applicant - King's College London (KCL)
Christina Ramsenthaler - Collaborator - King's College London (KCL)
Irene Higginson - Collaborator - King's College London (KCL)
Lorna Fraser - Collaborator - King's College London (KCL)
Peter May - Collaborator - King's College London (KCL)
Sarah Mitchell - Collaborator - University of Leeds
Stephen Barclay - Collaborator - University of CambridgeOutcomes:
For the adult (aged ⥠18) population:
Primary outcome: Three or more emergency hospital admissions in the last 90 days of life.
Secondary outcomes: Trends in primary care use and emergency hospital admissions over the study period; costs associated with primary and secondary care delivery for people with life-limiting conditions and cost projections based on different scenarios
For the children and young people (aged â¤25) population:
Primary outcomes: Number of/Incidence rate of emergency hospital admissions during the last 12 months of life; length of stay
Secondary outcomes: Changes in patterns of primary care and emergency hospital admissions during the transition period between childhood-paediatric services and adulthood-adult services.Description: Lay Summary
People with serious illnesses who are approaching the end of life would often prefer to avoid unnecessary hospital stays. Understanding how primary care can help prevent unplanned hospital stays will help policymakers improve care. First, we will focus on adults with a serious illness to understand which aspects of care provided by GPs and community nurses are associated with people having fewer emergency admissions in the last three months of life. We will then find out which groups of patients (e.g., based on ethnicity, socioeconomic position, diagnosis, and number of conditions) are likely to experience the greatest benefit from these actions. For adults, our main measure will be having three or more emergency admissions in the last three months of life. Second, we will focus on children and young people (aged under 25) with serious illnesses in their last year of life to understand how often they have emergency admissions, and which groups are most likely to be admitted. We are particularly interested in exploring the âtransitionâ period when children move to adult services. We will use information from health databases (GP and hospital) to explore the links between primary care and emergency admissions near the end of life. This research will gather information to improve and personalise care provided by GPs and community nurses for people with a serious illness. By understanding which groups will benefit most from these improvements, the research should help to reduce the strain on hospital services.
Technical SummaryAims: (i) to examine the association between primary care activities and emergency hospital admissions for adults with life-limiting illnesses who are approaching the end of life (ii) to understand which primary care activities are associated with the risk of emergency hospital admissions, and in which groups this association is strongest (iii) to explore patterns of primary care and acute care use among children and young people with life-limiting conditions in the last year of life, and (iv) changes in patterns of healthcare use during the transition period between paediatric and adult services.
Population: People who died between 2010 and 2023.
Study design: Retrospective population-based cohort study.
Data sources: Linked data across primary (CPRD Aurum) and secondary care (HES APC) data.
Primary exposure: GP activities
Primary outcomes: â¥3 emergency admissions in the last three months of life (adults â aged ⥠18 years old); number of emergency admissions in the last year of life (children and young people â aged ⤠25 years old)
Statistical tests: Descriptive statistics will be used for sociodemographic characteristics, primary care service use, the number of GP consultations in the last 12 months of life (including face-to-face and telephone consultations, in hours and out of hours), community nursing contacts and emergency hospital admissions.
Multilevel multivariable regression models will be used to estimate the association between exposures and the primary outcomes and variation (by ethnicity, socioeconomic position, geography, and type/number of conditions) and to identify groups where associations are strongest. For the children and young people cohort, regression discontinuity design will be used to address the aim (iv).
Implications: This project will provide data on how to improve primary care and outcomes for people with complex needs and relieve pressure on NHS in England and Wales.
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ID-420: Characteristics of patients with schizophrenia & cognitive impairment in schizophrenia: patient flow, healthcare, and social care resource use — Imperial College Health Partners...
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ID-420: Characteristics of patients with schizophrenia & cognitive impairment in schizophrenia: patient flow, healthcare, and social care resource use
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-24
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Schizophrenia. Commercial
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ID-421: Networked Data Lab: Topic 5 – Exploring waiting lists in NWL: the demographics of those waiting, and the impact of waiting, both on patients and the system — Imperial College Health Partners...
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ID-421: Networked Data Lab: Topic 5 – Exploring waiting lists in NWL: the demographics of those waiting, and the impact of waiting, both on patients and the system
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-24
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Waiting lists. Commercial
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ID-419: Investigating the impact of London’s Ultra Low Emission Zone on children’s health: evidence from NHS health records — Queen Mary University of London...
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ID-419: Investigating the impact of London’s Ultra Low Emission Zone on children’s health: evidence from NHS health records
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-24
Opt Outs: no information provided./p>
Organisations: Queen Mary University of London
Description: Children’s health. Commercial
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ID-423: Multiple Disadvantaged prevalence Westminster — Westminster City Council...
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ID-423: Multiple Disadvantaged prevalence Westminster
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-24
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Disadvantaged prevalence.
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ID-422: Polypharmacy – Renal health inequalities — Imperial College London...
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ID-422: Polypharmacy – Renal health inequalities
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Renal health.
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ID-418: The effect of herpes zoster vaccination on vascular inflammation-related health outcomes — Imperial College Healthcare NHS Trust...
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ID-418: The effect of herpes zoster vaccination on vascular inflammation-related health outcomes
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Vaccination. Commercial
Source
2024 - 07
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ADR England Research Community Catalyst: Youth Transitions — unknown...
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ADR England Research Community Catalyst: Youth Transitions
Where: unstated
When: 2024-7-23
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to build a research landscape informed by existing research and evidence gaps in the field of youth transitions. It provides opportunities to address these gaps using administrative data and offers a platform for existing and prospective researchers, policymakers, practitioners, and voluntary and community sector organisations to learn, collaborate and innovate.
Existing data allows us to map young peopleâs journeys through school, further and higher education, or other institutions (including care or prison), and onto their next steps. However, the quality and accessibility of this data varies, and it is not widely used. In addition, there is no existing cross-sector strategy outlining the requirements for usable datasets or future data linkages.
This community catalyst aims to map research evidence and data sources, identify potential avenues for better data linking, and create a cross-sector community of data users to answer important research questions. It will drive transformative insights around what works to support youth transitions and reduce inequalities.
The project is co-funded by ADR England, Youth Futures Foundation, and the Centre for Transforming Access and Student Outcomes in Higher Education (TASO). It is led by the National Foundation for Educational Research, together with their co-investigators at the University of Westminster, University College London, and FFT Datalab.
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Evaluating the benefits, costs and utility of synthetic data — unknown...
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Evaluating the benefits, costs and utility of synthetic data
Where: unstated
When: 2024-7-12
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Two complementary projects will explore the use of synthetic data. They will focus on low-fidelity synthetic data, which is artificial data that has been created to reflect the format of the original data (its layout and the types of information it contains) but without preserving any relationships between variables. The projects will explore the potential benefits, costs and utility of synthetic data for administrative data research.
Synthetic data â also known by other names such as artificial, dummy, simulated, mock or fake data â is an emerging area of development for supporting research using securely held administrative data. ADR UK has identified that low-fidelity synthetic datasets could be used:
for training purposes to explore whether a dataset could be helpful for a specific research project to support researchers with developing their code, understanding the structure of the data, and testing different statistical methods, before they can get access to the real data.These projects will collect evidence and insights on synthetic data from the perspective of two stakeholder groups:
Data owners and data providers, including trusted research environments: One project will explore the benefits and costs of synthetic data for this group, and mechanisms for providing synthetic data The public: One project will explore the publicâs understanding of and attitudes towards synthetic data.These projects will inform recommendations to scale the production and sharing of synthetic data, taking into account the views of these stakeholders. They will include developing shared terminology and agreed governance structures for synthetic data.
This is a jointly funded initiative from the Economic and Social Research Council (ESRC)âs Data & Infrastructure Programme and ADR UK.
Read more about the projects below.
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ADR England Research Community Catalyst: Children at Risk of Poor Outcomes — unknown...
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ADR England Research Community Catalyst: Children at Risk of Poor Outcomes
Where: unstated
When: 2024-7-22
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project will build a community of researchers and analysts focused on children and young people supported by early intervention services or childrenâs social care in the UK. This community will serve as a vital point of connection, information sharing, and coaching, and provide national strategic leadership for administrative data and research in this field.
Children in contact with early intervention services or childrenâs social care tend to be at greater risk of poor social, health and educational outcomes. National and local organisations supporting these children produce a wealth of administrative data as they carry out their services. These data could be used to explore how to reduce these risks and ultimately improve childrenâs lives.
However, at present, not enough researchers are using these data, nor are they consistently addressing the issues most important to policymakers, practitioners, or families. Knowledge is fragmented; there is no clear sense of research gaps or priorities, and where evidence exists, it is often underused.
Co-funded by ADR England and Foundations â What Works Centre for Children and Families, this project will establish a broad and diverse community of researchers and analysts focused using (or aspiring to use) de-identified administrative data, to address these issues. It is led by Swansea University, Lancaster University, Imperial College London, University College London, and the University of Sussex. The project is also supported by:
Barnardo's Data to Insight Childrenâs Commissionerâs Office Nuffield Family Justice Observatory
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Cross-Sectional study of smoking prevalence and smoking cessation interventions among UK people living with diabetes — Maria Duaso ...
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Cross-Sectional study of smoking prevalence and smoking cessation interventions among UK people living with diabetes
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-09
Organisations:
Maria Duaso - Chief Investigator - King's College London (KCL)
Maria Duaso - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Deborah Robson - Collaborator - King's College London (KCL)
Francesca Fiorentino - Collaborator - King's College London (KCL)
John Robins - Collaborator - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)Outcomes:
Smoking status;
Record of support and treatment for smoking cessation;
Record of prescription for one or more smoking cessation medication;
Record of attendance to stop smoking services;Description: Lay Summary
Almost 5 million people in the UK have diabetes, a disease that makes it hard for the body to control sugar levels. This research is about how smoking affects people with diabetes. Smoking makes diabetes worse by making it harder for the body to control sugar, causing swelling inside the body, and increasing bad fats in the blood, which can be dangerous.
The study wants to find out how many people with diabetes smoke and what kind of help they get to stop smoking. The researchers will look at whether people with diabetes smoke now, used to smoke, or never smoked. They will also see what kind of help they get to quit smoking, like talking to a counsellor, getting medicine or using e-cigarettes.
The goal is to see if there are differences in smoking and getting help to quit among different groups of people, like those with Type 1 or Type 2 Diabetes, men and women, people from different ethnic backgrounds, and people living in different socioeconomic conditions. This can show whether some groups are more likely to smoke, have more trouble quitting, and have more difficulty getting help than others.
By finding out which groups need the most support, the study will help healthcare professionals create better plans to make quitting smoking easier for people with diabetes. This can help them manage their diabetes better and be healthier.
Technical SummaryIn the UK, where 4.9 million people live with diabetes,), the interrelation between diabetes management and lifestyle choices such as smoking warrants in-depth exploration. Smoking, known for its adverse effects on insulin resistance, inflammation, and cholesterol levels, significantly impacts the development and progression of diabetes. This association not only makes managing diabetes more challenging but also increases the risk of mortality, highlighting the need for targeted intervention strategies. Our cross-sectional study aims to investigate the prevalence of smoking among individuals living with diabetes and the provision of smoking cessation interventions.
The study will assess the prevalence of smoking behavioursâcurrent smoking, former smoking, non-smokingâamong individuals living with Type 1 Diabetes and Type 2 Diabetes (T2D). It will also examine the provision and use of smoking cessation interventions, such as behavioural support, pharmacological treatments, and switching to vaping, across diverse demographic and socioeconomic groups.
We will use data from the Clinical Practice Research Datalink (CPRD), including primary care data (CPRD GOLD, CPRD Aurum) and patient-level Index of Multiple Deprivation (IMD) data. The study period spans from September 1, 2021, to March 31, 2024, and includes patients aged 18 or over with a diagnosis of diabetes.
Statistical methods will include descriptive statistics to outline smoking prevalence and cessation support use, univariate analyses to explore initial associations, and multivariate logistic regression models to assess the effects of demographic and socioeconomic variables on smoking status and cessation support. Covariates will include age, gender, ethnicity, socioeconomic status (IMD), type of diabetes, and comorbidities.By identifying patterns and determinants of smoking behaviour among people living with diabetes, this study aims to inform targeted public health and clinical management strategies. Improving smoking cessation support could markedly reduce diabetes-related complications and the overall impact of diabetes in the UK.
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Prenatal Antibiotic Exposure and Incident Chronic Diseases in Childhood — Daniel Horton ...
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Prenatal Antibiotic Exposure and Incident Chronic Diseases in Childhood
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-10
Organisations:
Daniel Horton - Chief Investigator - Rutgers Robert Wood Johnson Medical School
Alicia Iizuka - Corresponding Applicant - Rutgers, The State University of New Jersey
Abner Nyandege - Collaborator - Rutgers, The State University of New Jersey
Brian Strom - Collaborator - Rutgers, The State University of New Jersey
Dinesh Mendhe - Collaborator - Rutgers, The State University of New Jersey
Elizabeth Suarez - Collaborator - Rutgers, The State University of New Jersey
Jason Roy - Collaborator - Rutgers, The State University of New Jersey
Soko Setoguchi - Collaborator - Rutgers, The State University of New Jersey
Sophie Smith - Collaborator - Rutgers Robert Wood Johnson Medical School
Tobias Gerhard - Collaborator - Rutgers, The State University of New JerseyOutcomes:
Allergic or atopic diseases: asthma, allergic rhinitis, atopic dermatitis, food allergy
Autoimmune diseases: type 1 diabetes, thyroid disease (excluding congenital), juvenile idiopathic arthritis, inflammatory bowel disease, psoriasis, celiac disease
Metabolic diseases: type 2 diabetes, obesity
Negative Control: forearm fracture, burns, drowning, poisoning
Neuropsychiatric diseases: ADHD, depression, anxiety, autism spectrum disorder, and learning disability
Description: Lay Summary
Prenatal antibiotic use during pregnancy poses risks because the state of bacteria in the gut may influence immune and brain development of offspring. We will study how prenatal exposure to antibiotics might contribute to development of various chronic diseases in children, including asthma, allergies, type 1 and type 2 diabetes, juvenile arthritis, celiac disease, attention disorders, depression, anxiety, and autism. Children under age 18 whose mothers received antibiotics during pregnancy will be compared with children whose mothers did not receive antibiotics during pregnancy. We will use specific codes to study children diagnosed with the diseases of interest. We will study whether risks of chronic diseases relate to what kinds of antibiotics and how many courses were prescribed. To account for information that is not present in the data but could affect our results, we will also study whether children whose mothers received antibiotics during pregnancy are more likely to develop chronic diseases than siblings whose mothers did not receive antibiotics during pregnancy.
Technical SummaryWe will investigate relationships between prenatal antibiotic exposure and chronic childhood diseases linked to disruption of human microbiota. Cohorts of children (under age 18) with and without prenatal antibiotic exposure will be generated from CPRD data. The study population will include children in the linked mother-child CPRD dataset (Gold and Aurum). Linkage of children to mothers will allow adjustment for confounding variables (e.g., healthcare utilization, maternal medical conditions, maternal age at delivery). We will define antibiotic exposure as a prescription for antibiotics to the mother during pregnancy, stratified by trimester, with further categorization by type, spectrum of activity, and number of courses. Outcomes of interest include allergic / atopic diseases (asthma, allergic rhinitis, atopic dermatitis, food allergy), autoimmune diseases (type 1 diabetes, thyroid disease, juvenile idiopathic arthritis, inflammatory bowel disease, psoriasis, celiac disease), metabolic diseases (type 2 diabetes, obesity), and neuropsychiatric diseases (attention deficit hyperactivity disorder, depression, anxiety, autism spectrum disorder, learning disability). Apart from obesity, we will define outcomes primarily by Read Codes, ICD-10 Codes, SNOMED Clinical Terms, and secondarily by diagnostic codes combined with disease-specific treatments. Obesity will be defined using accepted cut-offs based on body mass index (BMI) Z-scores. Wherever possible, we will use validated outcome definitions. Children will be followed starting as early as birth. We will use multivariable Cox regression to study the association between antibiotic exposure and outcomes of interest, adjusting for maternal and environmental confounders. In addition to conducting a cohort study, we will also use a sibling-comparison design to compare disease incidence among siblings with discordant antibiotic exposures during gestation using stratified Cox regression. By providing detailed insights into the long-term risks of prenatal antibiotic exposure, this study will improve patient care by informing clinical decision-making and guidance regarding the use of antibiotics during pregnancy.
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Describing the hypertension prevalence and blood pressure control trajectories in people aged 40-years and identify need to management improvement in a future RCT (ACCELERATE-Feasibility analysis) — Eduard Shantsila ...
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Describing the hypertension prevalence and blood pressure control trajectories in people aged 40-years and identify need to management improvement in a future RCT (ACCELERATE-Feasibility analysis)
Datasets:GP data, CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-22
Organisations:
Eduard Shantsila - Chief Investigator - University of Liverpool
Eduard Shantsila - Corresponding Applicant - University of Liverpool
Chris Kypridemos - Collaborator - University of Liverpool
Gregory Lip - Collaborator - University of Liverpool
Iain Buchan - Collaborator - University of Liverpool
Paul Leeson - Collaborator - University of Oxford
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
Outcomes will be measured over 12 month after starting first BP-lowering treatment: Number of BP measurements; Number of changes of BP-lowering medications (dose change, stopping medication, starting new medication); BP response to different doses of BP-lowering medications; Number of measurements of renal function; Latest BP values at 12 weeks, 6 months and 12 months after starting BP-lowering treatment; Proportion of patients achieving target BP at 12 weeks, 6 months and 12 months after starting BP-lowering treatment; Worsening renal function; Out of range blood potassium levels.
Description: Lay Summary
High blood pressure (BP), a condition called hypertension, leads to more deaths than any health risk except age. Despite the best NHS efforts, only half of people who started on BP-lowering drugs have BP controlled a year later. One reason for poor BP control is that most people with hypertension need several BP-lowering drugs, but the current practice is to start with a low dose of one drug, gradually increasing the dose, and adding more drugs. This causes delays while waiting for the treatment responses, arranging BP monitoring, and repeating blood tests, which can be frustrating and puts people at high risk of never reaching the target.
We recently proposed a study to assess if starting and, if necessary, adding BP-lowering treatments at full doses in younger patients (aged 40-59) helps to achieve BP control sooner and safely. The study intends to compare the proposed full-dose approach to the current starting low-dose drugs with a gradual dose increase.
To develop the study and justify the scale of possible benefits we aim to use CPRD data (feasibility analysis). We will count the number of patients who start their first treatment of hypertension and may be suitable for the future study. We will analyse what happens with their BP management in current practice, including need to repeatedly monitor BP, do blood tests, side effects, and response to different doses of BP-lowering drugs. We will use this information to design the future testing of the proposed new way of starting their treatment.
Technical SummaryWe plan a grant application for a randomised controlled trial (RCT) to establish if starting pressure (BP)-lowering drugs using full recommended doses compared to the usual starting doses accelerates hypertension control in younger adults and is cost-effective. Following our initial proposal submission, the funder indicated that further information is needed to support the proposal justification.
This feasibility analysis aims to obtain data needed to support the RCT justification and design. It will describe the number of younger patients with new hypertension who are started on BP-lowering drugs and their hypertension management journey over the first 12 months.
The objectives of the feasibility study are:
- Establish the counts of the affected population who will be eligible for the RCT
- Describe the patient's journey over 12 months after starting BP-lowering medications, including follow-up BP measurements, monitoring of renal function, adverse reactions, and achieving BP targets.
- Describe changes in BP-lowering drugs
- Describe BP response to different doses of BP-lowering drugsThe feasibility analyses will be done using Clinical Practice Research Datalink (CPRD) Aurum database. The database is based on electronic health records of the most popular primary care system, called EMIS. The study team uses EMIS in clinical practice and will use it for future patient recruitment. High-quality data extraction is achievable from routine clinical codes, based on Quality and Outcomes Framework metrics and maintained at high standards in general practice.
The study population will consist of patients aged 40-59 years who have recently been diagnosed with hypertension and have just started their first BP-lowering treatment. Exclusion criteria list clinical conditions where initiating full-dose treatment may pose safety risks.
Analysis will include metrics of BP monitoring, safety monitoring (renal function), adverse reactions, timing of BP-lowering drug changes and BP responses to those changes to produce descriptive statistics (R software).
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The epidemiology, impact, and outcomes of idiopathic inflammatory myopathies — Michael McLean ...
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The epidemiology, impact, and outcomes of idiopathic inflammatory myopathies
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-18
Organisations:
Michael McLean - Chief Investigator - Pfizer Ltd - UK
Emma Jones - Corresponding Applicant - Momentum Data Ltd
Andrew McGovern - Collaborator - Momentum Data Ltd
Anita Lynam - Collaborator - Momentum Data Ltd
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Muhammad (Ashkan) Dashtban - Collaborator - Momentum Data Ltd
Serhan Bahit - Collaborator - Momentum Data LtdOutcomes:
1. Incident IIM overall and by IIM disease subtype: dermatomyositis (DM), juvenile DM, polymyositis (PM), and inclusion body myositis (IBM).
2. All-cause mortality
3. Malignancy (haematological and solid cancers, captured from primary and secondary care records)
4. IIM-specific comorbidities
- ILD (insterstitial lung disease, including cases of pulmonary hypertension)
- dysphagia (including cases of percutaneous endoscopic gastrostomy feeding)
- myocarditis
- common mental health disorders (depression and anxiety)
5. Secondary care healthcare utilisation, comprising secondary care referrals, emergency department admissions, hospital admissions, and high dependency/intensive care admissions.
6. IIM symptoms comprising muscle weakness, joint pain, fatigue, dysphagia, elevated ALT, estimated from primary and secondary care records.Description: Lay Summary
Idiopathic inflammatory myopathies (IIM) is a collective name for a group of conditions causing inflammation and weakness of the muscles. This group includes dermatomyositis, juvenile dermatomyositis, and polymyositis. Inclusion body myositis is a related condition with several similar symptoms. In addition to affecting the muscles, some of these conditions can cause a skin rash and some cause problems with internal organs. A person can develop an IIM at any time in their life. The condition can be difficult to diagnose, and symptoms tend to worsen over time.
The number of people in the UK diagnosed and living with an IIM, and the impact of the IIM on their long-term health, is not well known. This study will estimate the number of people in the UK diagnosed with an IIM and see if the age, sex, ethnic background, geography and socioeconomic status of people with an IIM differ to people without an IIM. This project will also compare the number of hospital attendances for people with an IIM and explore whether they face a higher risk of complications, such as cancer and mortality, compared to those people without an IIM. Additionally, we will investigate if symptoms of IIM can be used to help health professionals make earlier diagnosis of IIM.
This study will have clear patient benefit by providing information to support health professionals through raising awareness of these conditions, and supporting improved early diagnosis and treatment of IIM.
Technical SummaryIdiopathic inflammatory myopathies (IIM) is a collective name for a group of heterogenous conditions comprising dermatomyositis, juvenile dermatomyositis, polymyositis, inclusion body myositis. There have been limited population-based studies examining IIM. This study will include a detailed characterisation of these conditionsâ epidemiology, symptoms and an analysis of comorbid patterns and secondary health resources utilisation in comparison with unaffected controls.
All people (aged â¥2 years) registered in CPRD Aurum since March 2001 whose data quality is considered acceptable for research and with valid linkage to hospital episode statistics, death registration data from the Office for National Statistics, and index of multiple deprivation data, will be eligible. IIM will be identified primarily using coding in HES with additional identification investigated in primary care.
IIM incidence and prevalence will be calculated overall and in sociodemographic subgroups, using a population denominator. To evaluate clinical outcomes, adults with IIM will be disease risk score matched using 1:4 ratio with unaffected controls. Excess all-cause mortality and malignancy will be assessed using adjusted Cox proportional hazards models. Occurrence of immune-mediated inflammatory disease specific comorbidities (interstitial lung disease, dysphagia, myocarditis, common mental health disorders) at IIM diagnosis and within 2 years will be evaluated using adjusted logistic regression. Secondary care utilisation will be evaluated using adjusted Poisson models. The risk for these outcomes in people with IIM vs controls will be compared with the risk for the same outcomes in people with rheumatoid arthritis and systemic lupus erythematosus to assess whether IIM associated risks are comparable to the disease associated risks in these two more studied conditions.
Common IIM symptoms (muscle weakness, joint pain, fatigue, dysphagia, elevated alanine transaminase [if sufficient numbers]) will be evaluated using conditional logistic regression. A descriptive analysis of early symptomatology prior to IIM diagnosis will explore opportunities for improving the timing of IIM diagnosis.
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Influence of Attention-deficit hyperactivity disorder (ADHD) on antihypertensive medication treatment persistence — Kenneth Man ...
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Influence of Attention-deficit hyperactivity disorder (ADHD) on antihypertensive medication treatment persistence
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-23
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Siu Chung Andrew Yuen - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - University College London ( UCL )Outcomes:
Primary outcome:
First antihypertensive medication discontinuation: It will be defined as a gap of more than 30 days between consecutive prescriptions1 in the primary analysis.Secondary outcome:
Proportion of days covered (PDC): PDC will be calculated by calculating the proportion of days in which a person has access to the antihypertensive medication over a given period of interest.2 PDC = (Sum of days covered by antihypertensive medication in time frame) ÷ (number of days in time frame) à 100%. PDC will be calculated over 1-, 2- and 5-years follow-up lengths after the first prescription start date. PDC < 80% will be defined as "poor persistence".3-6Description: Lay Summary
Attention deficit hyperactivity disorder (ADHD) is a condition that can make it difficult for individuals to focus and manage daily task. It is also linked to a higher risk of high blood pressure and other heart problems. Control of high blood pressure often requires taking medications regularly, however, people with ADHD may find this challenging due to symptoms like impulsivity and inattention. This study aims to understand how ADHD and its treatments affect how well people adhere to their blood pressure medications.
We will investigate if individuals with ADHD are more likely to stop taking their blood pressure medications compared to those without ADHD. Additionally, we will also examine if ADHD medications can improve adherence to blood pressure treatments among people with ADHD.
Using data from CPRD, we will follow a large group of adults who began taking blood pressure medications between 2001 and 2020. We will analyse how long it takes for patients to stop their medications and how consistently they take them over different periods.
Understanding these relationships can help doctors better support patients with ADHD in managing their blood pressure, potentially leading to improved health outcomes. Given the widespread use of blood pressure medications and increasing recognition of ADHD, our findings could influence clinical practices and health policies globally, ultimately helping patients make better-informed decisions about their treatments.
Technical SummaryAttention deficit hyperactivity disorder (ADHD) poses long-lasting and debilitating impact in various aspects of an individualâs life. In adulthood, the more overtly disruptive ADHD symptoms experienced in childhood often shift into more subtle symptoms such as inner restlessness, inattention, disorganisation, and difficulties in executive functioning. ADHD is also associated with a wide range of cardiovascular diseases, including hypertension.
This study aims to evaluate the impact of ADHD and ADHD medication on adherence to antihypertensive medications. Hypertension management critically depends on medication adherence, yet individuals with ADHD may struggle due to symptoms, potentially leading to poorer outcomes.
We will employ a population-based cohort design using data from the Clinical Practice Research Datalink (CPRD). Our study will include adults aged 18 or above who initiated antihypertensive medication between 1st January, 2001 and 31st December, 2020.
The primary objective is to assess the association between ADHD and the time to first discontinuation of antihypertensive medication. We will also evaluate the persistence of antihypertensive medication, measured by the proportion of days covered (PDC) over 1-, 2-, and 5-year follow-up periods, with PDC < 80% defined as "poor persistence". Additionally, we will investigate the impact of ADHD medication on antihypertensive persistence in individuals with ADHD.
We will use Cox regression to estimate hazard ratios (HRs) for the time to first discontinuation, and logistic regression to analyse patients with PDC defined as âpoor persistenceâ, adjusting for relevant covariates such as age, sex, ethnicity, other cardiometabolic medications and conditions, and comorbid psychiatric conditions. Subgroup and sensitivity analyses will be conducted to provide a comprehensive understanding of the relationships between ADHD, ADHD medication, and antihypertensive medication adherence.
This research will provide insights into how ADHD impact the management of hypertension, potentially informing targeted interventions to improve medication adherence and overall clinical outcomes in patients prescribed with antihypertensive medications.
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Disease trajectory and long-term health impacts of treatment among COPD patients across distinct phenotypes in England — Jennifer Quint ...
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Disease trajectory and long-term health impacts of treatment among COPD patients across distinct phenotypes in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-25
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Harley Kwok - Corresponding Applicant - Imperial College London
Alexander Adamson - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College LondonOutcomes:
COPD exacerbations;
All-cause mortality; COPD-related mortality;
COPD-related hospital admission and readmission.Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a major health issue, being the fourth leading cause of death and affecting 3 million adults in the United Kingdom. Mostly caused by smoking, COPD includes conditions where the airways are inflamed and the lungs are damaged. Patients with COPD often have a long-lasting cough and breathlessness and need treatments to help them breathe better. All patients with COPD get inhalers, sometimes just one type, but often two or three, depending on how bad their symptoms are.
Currently, COPD treatment mainly focuses on easing symptoms rather than addressing the root causes, which misses the complexity of the disease. To get a better understanding of how different treatments work for various groups of COPD patients, we are planning a study. We will group COPD patients based on their medical and social similarities, then look at how their disease progresses over time and how inhaler treatments affect their health. We will use different computer methods to do this, like grouping similar patients together. By the end of this study, we hope to learn more about how COPD naturally progresses and how different inhaler combinations affect short- and long-term health. This could help us improve how we understand and treat COPD, by tailoring treatments to individual needs.
Technical SummaryBackground
Chronic obstructive pulmonary disease (COPD) encompasses diverse clinical and pathophysiological traits known as phenotypes. Existing classifications predominantly focus on clinical manifestations and pulmonary function, overlooking modifiable risk factors like smoking. Despite extensive research on the side effects of COPD treatments, long-term treatment effects remain poorly explored in light of patient heterogeneity. Leveraging electronic health records, the findings of this study hold promise for broader applicability across the UK population.Aims and objectives
The overarching objective of this study is to explore COPD disease progression and its association with related medications among people with COPD categorised by different phenotypes in electronic health records. We will achieve this through three aims:
1. Generate COPD phenotypes in CPRD Aurum and compare the predictive performance of health outcomes between the newly derived phenotypes and those in literature.
2. Explore and compare COPD trajectory across the derived COPD phenotypes.
3. Explore the long-term health impacts of COPD treatment across COPD phenotypes.Exposure
The primary exposure of interest which will be used to define the cohort is the derived COPD phenotypes from Aim 1.Outcomes
Time to all-cause and COPD-related mortality, COPD exacerbations, and COPD-related hospital admissions and readmissions.Study design
Retrospective cohort study.Methods
We will conduct clustering analyses to partition COPD patients according to their similarities and derive COPD phenotypes, followed by a cohort study investigating the disease trajectory of COPD and a risk prediction modelling study exploring the long-term health impacts of COPD treatments across phenotypes.Main statistical tests
We will quantify the effect of phenotypes to disease outcomes and their relationship with COPD treatments by calculating hazard ratios using cluster-specific adjusted Cox regression models.Public health benefit
Results from this study can lead to improved diagnosis, characterisation and management of COPD.
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SPeeding up Referral and Improving New diagnosis Time in Juvenile onset Systemic Lupus Erythematosus (SPRINTS) — Pieta Schofield ...
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SPeeding up Referral and Improving New diagnosis Time in Juvenile onset Systemic Lupus Erythematosus (SPRINTS)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-04
Organisations:
Pieta Schofield - Chief Investigator - University of Liverpool
Clare Pain - Corresponding Applicant - Alder Hey Childrenâs NHS Foundation Trust
Michael Beresford - Collaborator - University of Liverpool
Olivia Lloyd - Collaborator - Alder Hey Childrenâs NHS Foundation Trust
Sarah Rodgers - Collaborator - University of LiverpoolOutcomes:
Primary outcomes:
Confirmed diagnosis of SLE and/or a Lupus like conditionSecondary outcomes:
All-cause unplanned hospital admissions, primary care recorded accident and emergency attendances and referrals and all-cause mortalityDescription: Lay Summary
Lupus is an autoimmune disease where the immune system is overactive causing harm to any organ or joint in the body. This can include the kidney, heart and lungs and can be fatal without a fast diagnosis and the correct treatment. Lupus symptoms can vary hugely between patients and early diagnosis and treatment is crucial in the life outcome for children.
Technical Summary
In the UK, children with lupus continue to experience significant delays in diagnosis and delays in accessing specialist care and starting life-saving treatments. Symptoms of lupus include fatigue, rashes, joint pains, headaches, mouth ulcers and blood circulation problems, but these are also found in children without lupus.
We will study what symptom or groups of symptoms a child presents to their GP with before their diagnosis of lupus and referral to hospital. If GP clinicians, as the means of accessing specialist care, are alerted to this group of symptoms earlier, it could speed up diagnosis and ensure the best possible patient outcomes.
We will use data from two UK primary care databases to understand the pathway to referral including focusing on âgroups of symptomsâ which might help GPs recognise lupus early.
To understand these pathways to diagnosis we will work with children, families, healthcare professionals and LUPUS UK to speed up diagnosis. Our findings will be presented to children and families, and to primary care and health professionals. This will allow us to create educational materials to raise awareness of lupus to facilitate faster diagnoses.Systemic Lupus Erythematosus (SLE), is a rare systemic autoimmune condition. While 1 in 5 people commence symptoms in childhood, children and young people often face diagnostic delays. The symptoms of lupus are also common in children without lupus. Identifying those patients who would benefit from early referral from others with similar symptoms but who wonât subsequently develop SLE is a significant challenge.
Our aim is to seek robust evidence that will speed up referral, diagnosis and access to appropriate care for patients who have developed or are developing Juvenile SLE (JSLE), by looking for patterns of symptoms and examinations that identify and encourage appropriate referrals early in the patientâs pathway.
We will use cohort of patients with codes for common symptoms associated with lupus and compare the symptom sets and pathways of those who receive an eventual diagnosis of JSLE aged up to 16 years or younger and/or receiving a diagnosis of SLE between the ages of 16 and 30 years, with those who have no eventual JSLE diagnosis (or SLE) diagnosis. For those presenting to their GP with lupus like conditions, we will examine pathways for events associated with earlier referral and diagnosis. We will use a combination of association rules analysis, multinomial logistic and cox-proportional hazards regression modelling to explore association of events and pathways with eventual diagnosis and time from initial symptom presentation to eventual diagnosis. We will examine hospital episodes for association between pathway to diagnosis with unplanned hospitalisation and mortality outcomes, using linear and Poisson regression.
We will use HES data to corroborate (J)SLE diagnosis codes. We aim to examine association of socio-economic status and ethnicity on outcomes by using IMD linkage and ethnicity linkage. We will use admitted patient care and Office of National Statistics death certificate linkage to look at health outcomes.
Source - and 31 more projects — click to show
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Machine Learning Driven Retrospective Database Study in Patients with Epilepsy and Comorbid Major Depressive Disorder — Martina Pili ...
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Machine Learning Driven Retrospective Database Study in Patients with Epilepsy and Comorbid Major Depressive Disorder
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-04
Organisations:
Martina Pili - Chief Investigator - IQVIA Ltd ( UK )
Sophia Fleming - Corresponding Applicant - IQVIA Ltd ( UK )
Alexandrina Lambova - Collaborator - IQVIA Solution Bulgaria EOOD
Julia Gallinaro - Collaborator - IQVIA Ltd ( UK )
Pejman Farhadi Ghalati - Collaborator - IQVIA Commercial GmbH & Co. OHG (Deutschland)Outcomes:
The following outcomes will be predicted in the study:
⢠Death: binary outcome
o Cause of death
⢠Hospitalisation: binary outcome
o Reason for hospitalisation
⢠Depression onset: binary outcome
⢠Epilepsy onset: binary outcomeDescription: Lay Summary
It is estimated that 20-35 percent of patients with epilepsy, a seizure disorder of the brain (where uncontrolled electrical activity between brain cells leads to a numerous symptoms), also suffer from Major Depressive Disorder (a mental health condition that causes a persistently low or depressed mood and a loss of interest in activities that once brought joy). People with epilepsy and depression can present atypical symptoms which may be missed by their treating doctor. By using machine learning (ML) large volumes of data can be assessed and new correlations between the two diseases can be explored to increase the understanding of these conditions and the people impacted by these diseases. In epilepsy research ML has already been used for multiple applications including detecting seizures and predicting treatment outcomes. Literature on people with epilepsy and depression is both outdated and limited.
Technical Summary
The overall aim of the study is to explore the mutual relationship between epilepsy and depression, focusing on treatment patterns and patient management. The study will address how epilepsy may affect development of depression and vice versa, and influences of the two conditions on patientsâ management, treatment choices, and clinical results by using a ML methodology. Knowledge on factors associated with comorbid epilepsy and depression could be helpful for early diagnoses and improved treatment choices.This is a real-world retrospective database study leveraging Machine learning (ML) to better understand the bi-directional relationship between epilepsy and depression. The studyâs primary objectives will be to identify predictors of depression in patients with epilepsy (PWE), describe the differences in patient characteristics, management and treatment patterns in PWE before and after a depression diagnosis and identify predictors of certain outcomes (i.e. hospitalization and/or death) in PWE. The secondary objectives will be to identify predictors of epilepsy in patients with depression (PWD), and describe the differences in patient characteristics, management and treatment patterns in PWD before and after an epilepsy diagnosis. This study is part of a multi-country study where the objectives listed above will be investigated. In the UK, the study will use CPRD linked with HES, IMD and ONS data to capture demographics, socio-economic status, diagnoses, drug exposures, laboratory and pathology testing, referrals to hospitals and specialists as well as hospital admissions, related procedures and emergency room visits, and death. Two populations, PWE and PWD will be considered in the analysis and defined using ICD10 WHO and SNOMED codes from HES and CPRD, respectively. For the objectives involving the identification of predictors, supervised ML will be leveraged for prognostic purposes. ML classification algorithms (e.g., eXtreme Gradient Boosting and Light Gradient Boosting Machine etc.) will be used to train predictive models. Model evaluation will be performed using cross-validation methods and metrics such as recall, precision and area under the precision-recall curve. Finally, feature importance analysis (e.g. SHAP) will be used to identify and rank the important predictors.
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A comparison of clinical outcomes in patients with asthma newly initiating Inhaled Corticosteroid (ICS) and Long-acting beta 2 agonist (LABA) Relvar and Fostair combination inhalers in England. — Manish Verma ...
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A comparison of clinical outcomes in patients with asthma newly initiating Inhaled Corticosteroid (ICS) and Long-acting beta 2 agonist (LABA) Relvar and Fostair combination inhalers in England.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-17
Organisations:
Manish Verma - Chief Investigator - GSK India Global Service Private Limited
Alexander Ford - Corresponding Applicant - Adelphi Real World
Arunangshu Biswas - Collaborator - GSK India Global Service Private Limited
Emily Vinall - Collaborator - Adelphi Real World
Ines Palomares - Collaborator - GSK
Neha Shah - Collaborator - GSK
Rosie Wild - Collaborator - Adelphi Real World
Sanchayita Sadhu - Collaborator - GSK
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Sociodemographic and clinical characteristics; asthma exacerbations; medication use, adherence and persistence; dosage changes; healthcare resource utilisation (including GP visits, inpatient stays, outpatient visits, and emergency department visits)
Description: Lay Summary
Asthma is a common lung disease which causes breathing difficulties. It affects around 339 million individuals and causes approximately 461,000 deaths worldwide each year. Patients who have asthma may report chest tightness, wheezing, a cough and symptom flare-ups.
There are a range of drugs that are available for the treatment of asthma in the UK. To help prevent symptom flare-ups patients can be given inhaler treatments containing a combination of two types of drugs, taken together as part of a single inhaler. One type of this inhaler available to patients with asthma in the UK, includes a combination of inflammation preventing steroids (ICS) and long-acting drugs (LABA) which relax the airways; these inhalers are termed ICS/LABA inhalers. All ICS/LABA inhalers are intended to be used daily to prevent symptoms over an extended period of time. There are a range of ICS/LABA therapies available to patients with asthma in the UK, including fluticasone furoate/vilanterol (FF/VI), and beclomethasone dipropionate/formoterol fumarate (BDP/FOR).
This study aims to compare the effectiveness of FF/VI and BDP/FOR inhalers by looking at how often patients using these therapies experience symptom flare-ups. We will also compare between people taking FF/VI or BDP/FOR inhalers, the use of other asthma medication used to relieve symptom flare-ups, the use of healthcare services, and whether patients use their asthma medication according to treatment instructions. The results of this study can be used to better inform treatment decisions for people receiving care for asthma in the UK.
Technical SummaryAim: The aim of this comparative effectiveness research (CER) study is to compare the real-world effectiveness of fluticasone furoate/vilanterol (FF/VI) versus beclomethasone dipropionate /formoterol (BDP/FOR) ICS/LABA therapies, among patients with asthma in a general practice cohort in England.
Objectives: To assess the comparative effectiveness of FF/VI and BDP/FOR using the following outcomes: rate of moderate or severe asthma exacerbations (primary objective), moderate exacerbations, severe exacerbations, time-to-first exacerbation, asthma symptom control, healthcare resource utilisation, treatment use, persistence and adherence (secondary objectives). To describe seasonal trends in rate of moderate-to-severe exacerbations and time to ICS dose step-up from index.
Methods: A new-user, active comparator, retrospective cohort study using probability of treatment weighting (IPTW) to adjust for measured confounders will be employed using linked primary and secondary care data. Patients will be indexed on the first/earliest prescription of a single device FF/VI or BDP/FOR inhaler during 1st December 2015 to 28th February 2019, with a minimum of 12 months baseline and maximum of 12 months follow up available. A maximum of 12 months follow-up will be used to assess effectiveness outcomes.
Exposures: Patients with asthma in England newly initiating FF/VI or BDP/FOR ICS/LABA therapies. Respective dosage strata will be compared between treatment groups.
Outcomes: Asthma exacerbations, SABA use, healthcare use treatment patterns, medication use, persistence and adherence.
Data Analysis: IPTW will be implemented following propensity score (PS) generation. Comparisons made will be made on both weighted and unweighted treatment cohorts (those newly initiating different ICS/LABAs). Comparisons of rates will be made using rate ratios which will be calculated using a negative binomial model. Time-to-event comparisons will be made using a cox proportional hazards model. For comparisons treatment dose, and adherence and persistence. least squares and logistic regression models will be utilised, respectively. For regression models, 95% CIs and p-values will be generated.
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Risk factors of endometriosis and associated health outcomes in women in England — Francesco Zaccardi ...
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Risk factors of endometriosis and associated health outcomes in women in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-12
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Elpida Vounzoulaki - Corresponding Applicant - University of Leicester
Cameron Razieh - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Daniel Ayoubkhani - Collaborator - Office for National Statistics
Gemma Sharp - Collaborator - University of Exeter
Isobel Ward - Collaborator - Office for National Statistics
Kamlesh Khunti - Collaborator - University of Leicester
Navjot Kaur - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of Leicester
Vahé Nafilyan - Collaborator - Office for National Statistics - ONSOutcomes:
⢠The time between earliest symptom associated with undiagnosed endometriosis onset in primary care and secondary care diagnosis of endometriosis and whether this differs by patient characteristics (age, ethnicity, deprivation) or medical history (previous diagnosis of comorbidities).
⢠Trajectories of risk factors, therapy, and health-care utilisation (i.e., visits with doctors) before the development of endometriosis (i.e., comparing those who developed vs did not develop endometriosis).
⢠Incidence of long-term physical and mental health related complications, medication utilisation, healthcare resource utilisation, and risk factors control after the diagnosis of endometriosis and whether these differ between women diagnosed with endometriosis and those not diagnosed with the condition.Description: Lay Summary
Endometriosis is a condition where tissue similar to the lining of the womb grows outside of the womb, causing severe chronic pelvic pain. According to the World Health Organisation, endometriosis affects 10% of women of reproductive age across the world, with 1.5 million women in the UK estimated to be affected. Even though it is one of the most common gynaecological conditions, endometriosis can remain undiagnosed for years being often mistaken for other conditions. Endometriosis affects both physical and mental health, causing severe pain, fatigue, depression and fertility issues and increasing the risk of being diagnosed with other conditions in the future, including cardiovascular disease and cancer. This study will use routinely collected data from general practices and hospitals to answer three research questions. First, to investigate the delay between the first-time presentation of symptoms associated with undiagnosed endometriosis and date of diagnosis of endometriosis. Secondly, to compare patients with and without endometriosis before the development of the condition; for example, the change in the body weight in women who developed endometriosis compared to those who did not. Thirdly, to assess the long-term impact of endometriosis on multimorbidity, including associations with cardiovascular disease, diabetes, anxiety, depression, and mortality, and whether certain demographic characteristics and medical history increase the risk of being diagnosed with these conditions. The findings of this research will provide evidence showing how endometriosis affects women in England, and which factors increase the risk of diagnosis, aiming to inform policy change around interventions for timely diagnosis and treatment.
Technical SummaryEndometriosis is a chronic gynaecological condition with a rapidly increasing prevalence estimated to affect around 1 in 10 women of reproductive age. Despite its increasing prevalence, a diagnosis of endometriosis is made on average 8.4 years from onset of symptoms. Reasons for diagnostic delays include lack of accurate screening tools, or symptoms resembling other conditions leading to misdiagnosis. A diagnosis of endometriosis is associated with significant physical and mental health complications, and reduced quality of life. There is limited research assessing the impact of a delay in diagnosis on patient outcomes and a lack of contemporary data quantifying the risk of endometriosis in the general population, disease outcomes, and potential differences between sociodemographic groups.
The objectives of this research are i) to estimate consistency of endometriosis diagnosis between primary and secondary care data and the time between the first presentation of symptoms in primary care associated with undiagnosed endometriosis until a hospital diagnosis is received, and explore the impact of diagnostic delays; ii) to compare the trajectories of risk factors (i.e., body mass index, blood pressure), therapy, and healthcare resource in women who developed vs did not develop endometriosis; iii) to assess the risk of future health complications, medication and healthcare resource utilisation, and risk factors control following a diagnosis of endometriosis and disparities by sociodemographic groups (age, ethnicity, deprivation). In this observational cohort study with descriptive and hypothesis-testing elements, we will use data from CPRD Aurum, HES APC, Patient Level Index of Multiple Deprivation, and ONS Death Registration Data. Three cohorts will be extracted, from CPRD and HES APC. For the statistical analysis, we will use generalised linear models and survival analysis. These findings will guide policy recommendations that can influence decision making in healthcare, focusing on timely diagnosis and treatment, awareness and education and access to support.
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Kidney-related adverse events associated with intravitreal anti-vascular endothelial growth factor use in the UK: a national cohort study — Laurie Tomlinson ...
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Kidney-related adverse events associated with intravitreal anti-vascular endothelial growth factor use in the UK: a national cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-01
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ruth Costello - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Buchan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Qing Wen - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcome: â¥40% reduction in estimated glomerular filtration rate (eGFR)
Secondary outcomes: progression of albuminuria stage (A0 to A1 or 2, or A1 to A2); change in slope of eGFR progression; kidney failure defined as dialysis or kidney transplantation; development of coded nephrotic syndrome; a new diagnosis of hypertension; atrial fibrillation/flutter; myocardial infarction; peripheral arterial ischaemia identified through coded revascularisation procedures or diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE); ischaemic or haemorrhagic stroke; heart failure; cardiovascular death; all-cause mortality.
Control outcomes: diagnosis of herpes zoster; hip fracture
Description: Lay Summary
Anti-vascular endothelial growth factor (anti-VEGF) drugs are used to treat eye diseases, and are administered directly into the eyes. Doctors have recently become aware that anti-VEGF administered into the eye might have side effects in other parts of the body. These side effects include high blood pressure, urine protein leak and/or decline in kidney function. Over time, these effects could lead to kidney failure, requiring dialysis or a kidney transplant. However, doctors do not yet know how common or severe these problems might be.
We will use electronic health records from GP practices linked to hospital records to determine whether anti-VEGF administered directly into the eye are associated with side effects in other parts of the body in patients with eye disease. We will also assess whether anti-VEGF administered into the eye increases the risk of heart problems and/or death. We think it is important to inform patients about the risks of anti-VEGF treatment (especially kidney failure) as well as the benefits (preventing blindness) to inform decisions about their treatment. With help from our kidney and eye disease patient group, we will quantify these risks and summarise them in a way that is meaningful for patients. We will also use this information to inform doctors about how best to monitor patients who have been treated with anti-VEGF for eye disease.
Technical SummaryAnti-vascular endothelial growth factor (anti-VEGF) drugs block the development of new blood vessels and are increasingly used through intravitreal injection to treat age-related macular degeneration, diabetic macular oedema and other eye diseases. There is known to be systemic absorption of anti-VEGF from intravitreal injection, and there are several case-reports of systemic side effects including development of proteinuria and decline in kidney function. Analysis of adverse events from the original clinical trials for ophthalmic indications shows a signal of harm but these trials were small, of limited duration and did not have adjudicated cardio-renal end points.
We will use data from the clinical practice research datalink (CPRD) linked to hospital episode statistics (HES) to carry out a cohort study and self-controlled risk interval study to measure the association between anti-VEGF intravitreal injections and kidney related adverse events. We will use two study populations: 1) people without diabetes who have anti-VEGF intravitreal injections (exposed) versus cataract surgery (comparator), and 2) people with diabetes who have anti-VEGF intravitreal injections (exposed) versus laser photocoagulation (comparator), exposure and comparator status will be determined through OPCS codes in linked HES data. The primary outcome will be â¥40% reduction in estimated glomerular filtration rate (eGFR) determined through blood tests in the primary care record. In the cohort study we will use a propensity score weighted Cox proportional hazards regression model. The self-controlled risk interval approach uses cases only. We will compare the risk of the outcome during the year after first anti-VEGF intravitreal injection to the risk in the year prior, using a conditional Poisson regression model.
We will provide definitive information to patients and clinicians about the potential benefits and risks of treatment, to develop adequate monitoring if needed, and to prompt consideration of whether further randomised trials of enhanced vascular prevention during treatment are needed.
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Exploring the clinical pathways leading to hip joint replacement using large-scale electronic healthcare record data — Geraint Thomas ...
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Exploring the clinical pathways leading to hip joint replacement using large-scale electronic healthcare record data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-29
Organisations:
Geraint Thomas - Chief Investigator - Keele University
Dahai Yu - Corresponding Applicant - Keele University
Aleksandra Turkiewicz - Collaborator - Lund University
Andrea Dell'Isola - Collaborator - Lund University
Clara Hellberg - Collaborator - Lund University
Deepak Menon - Collaborator - Keele University
George Peat - Collaborator - Keele University
Martin Englund - Collaborator - Lund UniversityOutcomes:
Total Hip Replacement
Description: Lay Summary
Hip osteoarthritis is a common condition that can lead to difficulty in movement and pain, affecting many people worldwide. When this condition worsens, some may undergo hip replacement surgery, considered an effective treatment. Before reaching the stage where surgery might be needed, patients may receive various types of care, including medication and other less common surgical procedures. Our study will closely examine the care received by patients with hip osteoarthritis before they undergo hip replacement surgery. We aim to understand the different care strategies used, taking into account factors like age, gender, and where they live, to improve patient outcomes and inform future healthcare practices.
Technical SummaryOsteoarthritis is a progressive joint disease characterised by loss of articular cartilage which can present with pain, stiffness and functional decline. Hip osteoarthritis is a significant contributor to disability worldwide, with treatment guidelines advocating a mix of non-pharmacological, pharmacological, and surgical approaches. Total hip arthroplasty for advanced hip osteoarthritis affecting activities of daily living is widely recommended. However, the patterns of care leading up to hip replacement surgery and their impact on progression of disease are not well-defined. This includes the extent and duration of non-operative management (pharmacological and non-pharmacological) options offered prior to definitive total hip arthroplasty, the extent of other hip-related interventions and procedures utilised in management of hip osteoarthritis (including injections and arthroscopy), and the timing of arthroplasty in the context of disease progression. There is also a lack of clarity on how care varies based on demographic factors including age, sex, geographical location and socioeconomic status.
This proposed observational project aims to utilise descriptive and case-control analysis of data from primary and secondary healthcare sources, including linkage to Hospital Episode Statistics (HES) Admitted Patient Care data, to investigate the care timeline for hip osteoarthritis patients prior to hip replacement surgery. This includes examining healthcare consultations, both pharmacological and surgical interventions, and referrals to other services. In our descriptive analysis, we will conduct a retrospective case-only study among patients undergoing total hip arthroplasty for osteoarthritis to determine the prevalence of various care strategies within specific periods (such as 6, 12, and 24 months) before surgery. This will be stratified by patient demographics, socio-economic status (using linkage to Index of Multiple Deprivation data) and comorbidities. A nested case-control study will compare the care pathways of hip osteoarthritis patients who undergo total hip replacement with those who do not.
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An Update on the Estimate of Lyme Disease Incidence in England — Amanda Semper ...
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An Update on the Estimate of Lyme Disease Incidence in England
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-25
Organisations:
Amanda Semper - Chief Investigator - UK Health Security Agency (UKHSA)
Janie Olver - Corresponding Applicant - UK Health Security Agency (UKHSA)
Roberto Vivancos - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
⢠Number of patients diagnosed with Lyme disease and prescribed with appropriate antibiotics within primary care;
⢠Comparison of time series of primary care Lyme disease incidence numbers with a separate time series of laboratory-confirmed cases;
⢠Calculate whether the multiplication factor to apply to official laboratory-confirmed case data to estimate the overall incidence of Lyme disease in England has changed significantly post-2018.Description: Lay Summary
Lyme disease is a bacterial illness that is spread to humans by ticks. In early disease, around 6 in 10 people develop a rash that is specific to Lyme disease. This is commonly known as a bullseye rash. In England, the disease can sometimes be diagnosed clinically within the primary health care setting; if not, blood tests are needed for diagnosis. The official figures for the number of people diagnosed with Lyme disease are based on laboratory-confirmed cases from the national reference laboratory run by UKHSA. Previous work has suggested that for every case diagnosed at this laboratory, there are 2.35 cases recorded within primary care. This figure is known as the multiplication factor and allows the overall number of people diagnosed with Lyme disease in England to be estimated.
We think that this multiplication factor may now be out of date. This is because the National Institute for Health and Care Excellence introduced new guidance in 2018. From 2018, patients who have the bullseye rash should be diagnosed within primary care. Patients no longer need their diagnosis confirmed by tests run by the national reference laboratory. As the multiplication factor is based on pre-2018 data, it may mean the estimated figure for the overall number of people diagnosed with Lyme disease in England is lower than it should be. We want to access the primary care data from January 2013 to December 2023 in CPRD to determine whether this multiplication factor needs to be updated.
Technical SummaryLyme disease is a zoonotic tick-borne disease caused by bacteria in the Borrelia burgdorferi sensu lato genospecies complex. It is not a notifiable disease in the UK. This means that official incidence figures for England are based on the number of laboratory-confirmed cases at the UK Health Security Agency (UKHSA) reference laboratory (Rare and Imported Pathogens Laboratory, RIPL). However, general practitioners can make a clinical diagnosis of Lyme disease, so the official incidence figures are known to underestimate the true incidence.
A previous study that analysed primary care data in The Health Improvement Network (THIN) from 1998 to 2016, found that for every laboratory-confirmed case there are 2.35 cases identified within a primary care setting. This number has been used by UKHSA as a multiplication factor to estimate the total number of annual acute cases of Lyme disease. It is suspected that this multiplication factor may now be out of date. One reason for this is the introduction in 2018 of national guidance for the diagnosis and management of Lyme disease by the National Institute for Health and Care Excellence (NICE). Post-2018, patients presenting with a pathognomonic erythema migrans rash should be diagnosed without laboratory-confirmation.
This CPRD dataset will allow us to look both pre-introduction of the updated NICE guidance (pre-2018) and post-introduction (post-2018) to test the hypothesis that the multiplication factor has altered significantly post-2018 by running time series analysis models and looking for a structural break or interruption in 2018. It is important that the true incidence of Lyme disease is reported accurately by UKHSA to allow us to improve action on public health through data.
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HEAD-PAIN (Health inEqualities Associated with socioDemographic characteristics in migraine within Primary cAre IN England) — Grant O'Neil ...
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HEAD-PAIN (Health inEqualities Associated with socioDemographic characteristics in migraine within Primary cAre IN England)
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-02
Organisations:
Grant O'Neil - Chief Investigator - Pfizer Ltd - UK
Elke Rottier - Corresponding Applicant - Adelphi Real World
David PB Watson - Collaborator - NHS England
Hannah Gowman - Collaborator - Adelphi Real World
Kiran Rai - Collaborator - Adelphi Real World
Kostas Alexiou - Collaborator - Adelphi Real World
Lucinda Camidge - Collaborator - Adelphi Real World
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Robert Pawinski - Collaborator - Pfizer Ltd - UK
Sarah Law - Collaborator - Adelphi Real WorldOutcomes:
Clinical characteristics (comorbidities, Charlson Comorbidity Index (CCI), number of previous headache events, headache type at index, number of previous migraine events, symptoms, menopause status, previous diagnoses indicative of misdiagnoses), treatment patterns (time to first treatment, type of treatment, possible medication overuse (MO) status, referrals); HCRU/costs (primary care medication use, primary care consultations, medication costs [migraine-related and all-cause]), time from initial headache to migraine diagnosis.
Description: Lay Summary
Migraine is a common condition of the brain. Symptoms can include head pain, vomiting and sensitivity to light, sound and movement. Migraine costs the United Kingdom (UK) economy over £8 billion a year due to sick days and loss to productivity, with healthcare costs estimated to be over £1 billion a year.
Awareness, diagnosis and management of migraine is challenging even though there have been improvements in available treatment and knowledge of symptoms and risk factors in recent years. People with migraine have explained that getting a migraine diagnosis can be time-consuming, stressful and difficult â with many primary care healthcare professionals not recognising risk factors or symptoms felt by sufferers. There are known differences in the number of consultations for migraine with primary care healthcare professionals and specialist physicians across regions in the UK, however differences in how migraine is diagnosed and managed (in terms of medication and use of healthcare services) are not well known.
This study will describe differences in clinical characteristics, treatment patterns, healthcare resource use, medical costs and time to migraine diagnosis by age, sex, ethnicity, socioeconomic status, pregnancy status, rural/urban status and region. This will provide information on the existing migraine care pathway in the UK and ultimately provide benefits to public health.
Technical SummaryAim: To explore the health inequalities among people with migraine presenting to general practice (GP) primary care services in England using electronic health record (EHR) data. In acknowledgement of the under- and misdiagnosis of migraine in primary care, those with headache will also be included. Findings will be used to address gaps in existing literature regarding the extent to which health inequalities currently affect people with migraine in the UK.
Objectives: To describe i) sociodemographic characteristics of people with a recorded migraine diagnosis; ii) baseline clinical characteristics of people with a recorded migraine diagnosis; iii) treatment patterns in people with a recorded migraine diagnosis; iv) primary care healthcare resource use (HCRU) and associated direct medical costs of people with a recorded migraine diagnosis; v) sociodemographic characteristics of people with a recorded headache diagnosis; vi) baseline clinical characteristics of people with a recorded headache diagnosis; vii) to explore differences in time to diagnosis and time to treatment by line (1L onwards), primary care consultation rates and referral rates in pre, peri- and post-COVID pandemic periods in people with a recorded migraine diagnosis; and viii) to explore differences in primary care consultation rates and referral rates in pre, peri- and post-COVID pandemic periods in people with a recorded headache diagnosis.
Methods: A retrospective cohort study design will be employed using data from the CPRD Aurum linked to Index of Multiple Deprivation (IMD) and Rural Urban Classification (RUC) dataset.
Exposures: Migraine diagnosis, headache diagnosis.
Outcomes: Sociodemographic characteristics, clinical characteristics, treatment patterns, referrals, HCRU/costs, time to migraine diagnosis.Data analysis: Analysis will be descriptive in nature. Frequencies and percentages will be reported for categorical variables. Counts, means, medians and SDs will be reported for continuous variables. Outcomes will be stratified by sociodemographic characteristics.
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Survival analysis of fracture risk with depot medroxyprogesterone acetate (DMPA) compared to other long-acting reversible contraceptives (LARC) — Sophie Scanlon ...
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Survival analysis of fracture risk with depot medroxyprogesterone acetate (DMPA) compared to other long-acting reversible contraceptives (LARC)
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-09
Organisations:
Sophie Scanlon - Chief Investigator - MHRA
Sophie Scanlon - Corresponding Applicant - MHRA
Helen Booth - Collaborator - CPRD
Katherine Donegan - Collaborator - MHRAOutcomes:
All incident fractures.
Description: Lay Summary
Long-acting reversible contraceptives (LARCs) are contraceptive methods which do not need to be taken daily but also do not permanently prevent pregnancy. They are a highly effective group of contraceptive methods which includes the contraceptive injection, implant and intrauterine coils.
Technical Summary
Injectable depot medroxyprogesterone acetate (DMPA) is a LARC, the use of which has previously been associated with an increased risk of fractures. This study aims to compare the risk of fractures for users of DMPA with the risk of fractures for users of other LARCs within UK health care data. It will also explore if the risk varies by other characteristics such as age, ethnicity, and level of deprivation.
The rationale for the study is to provide robust evidence relating to fracture risk with DMPA â including evidence for other characteristics which may be more relevant to low- or middle-income countries (LMIC). This will help inform and enable the safe use of DMPA which has the public health benefit of being a highly effective, long-acting, method of contraception.Depot medroxyprogesterone acetate (DMPA) is an effective method of hormonal contraception however, it is known to decrease bone mineral density (BMD) and has previously been associated with an increased risk of fractures. The objective of this study is to quantify the risk of fractures for users of DMPA compared with users of other long-acting reversible contraceptives (LARCs) within UK primary care and linked secondary care data, building on previous work. A secondary objective would explore if the risk varied by patient characteristics such as age, ethnicity and quintile deprivation ranks.
A retrospective cohort study design will explore the incidence of fractures in DMPA users compared with users of non-DMPA LARCs in CPRD Aurum. Hospital Episodes Statistics (HES) data will be linked to the primary care data in order to define the outcome. The study population will be all women aged under 50 at the time of their first eligible contraceptive prescription, within the study period 1st January 2000 to 31st March 2021. The outcome will be incidence of any fracture, with multiple fractures on the same date counted as one event. Propensity scores and an inverse probability of treatment weighting (IPTW) method will be used to minimise risk of confounding. The primary objective will be evaluated using Cox proportional hazards models, which will allow for the inclusion of additional covariates. Survival curves will also be constructed based on stratification by other covariates such as ethnicity and quintile of deprivation ranks.
The rationale for the study is to provide robust evidence relating to fracture risk with DMPA â including evidence for other characteristics which may be more relevant to low- or middle-income countries (LMIC). This will help inform and enable the safe use of DMPA which has the public health benefit of being a highly effective, long-acting, method of contraception.
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Identifying early symptoms associated with a diagnosis of degenerative cervical myelopathy in primary and community care — Lianne Wood ...
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Identifying early symptoms associated with a diagnosis of degenerative cervical myelopathy in primary and community care
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-03
Organisations:
Lianne Wood - Chief Investigator - University of Exeter
Lianne Wood - Corresponding Applicant - University of Exeter
Christopher Clark - Collaborator - University of Exeter
Rob Anderson - Collaborator - University of Exeter
Sarah Bailey - Collaborator - University of ExeterOutcomes:
Diagnosis of degenerative cervical myelopathy
Patient pathway to receiving a diagnosis of degenerative cervical myelopathy
Incidence and prevalence of degenerative cervical myelopathy in a UK primary care populationDescription: Lay Summary
Degenerative Cervical Myelopathy (DCM) is a major reason for problems with the spinal cord. It often happens when the spinal canal in the neck gets narrower due to things like disc disease or arthritis. DCM is most common in people over 65 years old. More than 70% of people in this age group show signs of DCM on imaging, and about 25% of them have symptoms. If DCM isn't treated, it can lead to increasing disability and even paralysis. It costs the UK about £0.7 billion each year. People with DCM have the lowest quality of life compared to other chronic diseases.
Technical Summary
The first signs of DCM can be unclear and range from changes in feeling, difficulty walking, or problems with the neck or arms. Many patients I talked to say their regular doctors, emergency room doctors, and physiotherapists didn't know much about this condition. This, combined with the different symptoms people have, can mean it takes a long time to get a diagnosis and treatment. Since DCM naturally gets worse over time, it is important to improve the time it takes to receive a diagnosis (i.e. get an MRI scan) and the resultant treatment to prevent irreversible damage.
My plan is to look at routinely collected primary care data to understand what symptoms people with DCM presented with up to 5 years before they had surgery, to help us understand the scale of the problem in the UK, and to improve diagnosis.Degenerative Cervical Myelopathy (DCM) is the leading cause of spinal cord dysfunction. It is usually caused by acquired stenosis of the cervical spinal canal due to disc and/or osteoarthritic degeneration. DCM is most common in those over the age of 65 years. Over 70% of older individuals demonstrate radiological evidence of cord compression, and around 25% of these develop symptoms of DCM. If left untreated, DCM can lead to progressive disability and paralysis due to chronic spinal cord compression. The impact is far-reaching, with costs of £0.7billion per annum to UK society for those with known disease. Those with DCM report the worst quality of life scores across all chronic disease.
People with DCM (PwCM) report difficulty accessing a diagnosis and resultant treatment. It is estimated that delays to diagnosis and treatment are between 3-5 years, and half of this time is between onset of symptoms to referral. PwCM tell me there was a lack of awareness of DCM by their primary and community care practitioners, emergency care physicians, and this, coupled with the wide range of presenting features, may have contributed to the delays experienced.
Using key stakeholder engagement across care services, I aim to use data from the Clinical Practice Research Datalink to identify early presentations of DCM using retrospective data over five years before surgery or diagnosis for DCM. The aim of this project is to identify early features of DCM, map current management pathways in primary and community care. We will use a matched case:control (1:4) study design, to explore the diagnostic utility between frequently reported early DCM symptoms with a DCM diagnosis. We will also report incidence and prevalence within the UK. We will use routinely collected CPRD Aurum observational data, and link with HES Admitted Patient Care and Outpatient records to optimise diagnostic accuracy.
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Glucagon-like peptide-1 receptor agonists and the risk of gastro-oesophageal reflux disease in patients with type 2 diabetes — Samy Suissa ...
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Glucagon-like peptide-1 receptor agonists and the risk of gastro-oesophageal reflux disease in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-29
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Alain Bitton - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Yunha Noh - Collaborator - Sungkyunkwan UniversityOutcomes:
Gastro-oesophageal reflux disease (GERD) (based on Read codes and SNOMED-CT concept IDs outlined in Appendix 1).
Description: Lay Summary
Gastroesophageal reflux disease (GERD) is a common condition in which the stomach contents move back up from the stomach into the oesophagus (a tube that connects the mouth and the stomach). Patients with high blood sugar levels have a higher risk of developing GERD compared to those without. There is a rising concern that a common blood sugar-lowering drug, called glucagon-like peptide-1 receptor agonists (GLP-1 RAs), may increase the risk of developing GERD because it makes food stay in the stomach for longer periods and can cause food to reflux from the stomach; however, the available evidence on this is sparse. In the current study, we will use data from the Clinical Practice Research Datalink database to assess whether the use of GLP-1 RAs is associated with an increased risk of GERD, compared with the use of another blood sugar-lowering drug class, sodium-glucose cotransporter-2 (SGLT-2) inhibitors. This study will provide information that enables clinicians and patients to make a more informed decision when deciding on the most appropriate medication in patients with high blood sugar levels.
Technical SummaryGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) are being increasingly prescribed among patients with type 2 diabetes. Concerns are being raised about the delayed gastric emptying effect of GLP-1 Ras, resulting in gastro-oesophageal reflux disease (GERD); however, the available evidence remains scarce. Thus, the objective of this population-based study is to determine whether the use of GLP-1 RAs is associated with an increased risk of GERD when compared with the use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors among patients with type 2 diabetes. To address this objective, we will use the Clinical Practice Research Datalink database to identify patients at least 18 years of age newly treated with a GLP-1 RA or an SGLT-2 inhibitor between January 1, 2013 and December 31, 2021. Cox proportional hazard models will be used to estimate hazard ratios with 95% confidence intervals of GERD and its severe complications associated with GLP-1 RAs compared with SGLT-2 inhibitors. Secondary analyses will assess whether there is a duration-response relation, and whether the risk varies by individual GLP-1 RAs and patient characteristics, such as age, sex, body mass index, smoking status, duration and severity of diabetes, and specific comorbidities and drug use. This study will provide much needed information on increasingly prescribed GLP-1 RAs and their safety among patients with type 2 diabetes.
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Palliative and end-of-life care (PEOLC) in people with and without learning disabilities: registration, survival time, referrals and healthcare utilisation — Freya Tyrer ...
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Palliative and end-of-life care (PEOLC) in people with and without learning disabilities: registration, survival time, referrals and healthcare utilisation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-24
Organisations:
Freya Tyrer - Chief Investigator - University of Leicester
Freya Tyrer - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Joanne Miksza - Collaborator - University of LeicesterOutcomes:
Survival;
Recording and registration (i.e. end-of-life care register) of palliative and end-of-life care need (see Appendix 2);
Number of consultations;
Number of hospitalisations;
Health professional seen;
Referrals to specialist palliative care services (see Appendix 3)Description: Lay Summary
People with learning disabilities, also known as intellectual disabilities, have a shorter life expectancy than most other people. It is important that they are supported properly when they reach the end of their lives. However, health professionals, like doctors and nurses, find it hard to recognise when they need end-of-life care. This means that they may not get the care and support that they need. NHS England has recently set out some plans to improve end-of-life care for everyone. They stressed that people with learning disabilities should not be overlooked.
We will look at end-of-life care for adults, aged 18 years or over, with learning disabilities who visit the GP and hospital. People who are approaching the end of their lives are flagged by their GP who might place them on a special register (âend-of-life care registerâ) or simply label them as needing end-of-life care (âend-of-life care recordâ). In our study, we will compare people with and without learning disabilities. We will look at:
1. The characteristics of people who are on the end-of-life care register or have an end-of-life care record
2. How long people survive after having an end-of-life care record
3. People who die but are not registered as being at the end of their lives
4. How many hospital visits and consultations people have at the end of their lives
5. How many referrals there are to health specialists who provide end-of-life careWe will make recommendations to improve end-of-life care for people with learning disabilities.
Technical SummaryPeople with learning disabilities are known to experience significant health inequalities and inequities compared with most other people, including shorter life expectancy and poorer healthcare provision. Among them, they experience inequities in end-of-life care, often because healthcare professionals can fail to recognise when they are approaching the end of their lives owing to communication difficulties, diagnostic overshadowing (attributing all symptoms to the learning disability), and lack of training. Nonetheless, it is crucial that they are supported properly in accordance with NHS Englandâs policy ambitions.
This retrospective cohort study of Clinical Practice Research Datalink (CPRD) data, linked with hospital, mortality and deprivation data in England will map palliative and end-life-care trajectories of adults (â¥18 years) with learning disabilities and compare these in adults without learning disabilities. We will:
1. Investigate differences (by learning disability status) in the GP recording of generic end-of-life care and end-of-life care registration (see Appendix 2)
2. Investigate differences in survival time after GP recording and registration of end-of-life care
3. Compare the characteristics of people who die while registered at the GP surgery, but are not recorded as being at the end of their lives
4. Investigate the pattern of healthcare utilisation after GP recording of end-of-life care, as measured by the number of primary care consultations and secondary care episodes
5. Compare differences in referrals to palliative care specialistsStatistical analyses will combine age-standardised differences between proportions [objectives 1,2,5] and time-to-event analyses (Poisson [objective 4], flexible parametric methods/Cox models [objectives 2]). Our findings will provide evidence for existing policy ambitions and make recommendations on how these can be achieved. Ultimately, we hope to improve the quality of care and reduce health inequalities for adults with learning disabilities at a very challenging time for themselves and their family members.
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Incidence of and risks factors for the development of oesophageal cancer following treatment for head and neck cancer or lung cancer — Raoul Reulen ...
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Incidence of and risks factors for the development of oesophageal cancer following treatment for head and neck cancer or lung cancer
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-12
Organisations:
Raoul Reulen - Chief Investigator - University of Birmingham
Amar Srinivasa - Corresponding Applicant - University of Birmingham
Amar Srinivasa - Collaborator - University of Birmingham
James Martin - Collaborator - University of Birmingham
Lucinda Archer - Collaborator - University of BirminghamOutcomes:
1. Oesophageal squamous cell cancer or oesophageal adenocarcinoma diagnoses in patients with previous head and neck cancer or lung cancer
2. Oesophageal squamous cell cancer or oesophageal adenocarcinoma diagnoses in matched controls
Description: Lay Summary
Cancer of the food pipe (oesophagus) is one of the six cancers with the worst chance of survival. This is often because the cancers are found late when it is impossible to cure them. More research is needed to help find these cancers earlier when they are more treatable. Head and neck cancer are a group of cancers that affect the mouth, throat, and neighboring areas. Head and neck cancer and a common type of lung cancer called squamous cell cancer are often related to smoking and/or excess alcohol. Oesophageal cancer is often related to the same risk factors as these cancers. Moreover, treatment for both head and neck cancer and all forms of lung cancer can involve the use of radiotherapy, which can damage nearby structures such as the oesophagus and that damage can potentially increase the risk of a second cancer several years after the first one is treated.
In the USA there are strict screening guidelines for oesophageal cancer in patients with previous head and neck cancer with routine examination of the oesophagus and stomach via a camera test every 6-12 months for 12 years. However, there is no such screening program in the UK and understanding the risk of developing oesophageal cancer in patients with head and neck cancer, along with lung cancer, is essential to improve cancer outcomes in this patient group.
Technical SummaryIntroduction
Each year in the UK 9,200 people develop oesophageal cancer. Their prognosis is often poor and only 16% of people with oesophageal cancer survive 5 years (NOGCA report 2021). Studies suggest the lifetime risk of developing these cancers are high following head and neck cancer. Also risk factors for lung cancer are similar to oesophageal cancers.Aim
The primary aim is to examine the incidence of oesophageal squamous cell cancer and oesophageal adenocarcinoma following a diagnosis of either head and neck cancer or lung cancer.Methods
A population-based retrospective cohort study using CPRD Aurum and CPRD GOLD with linked Hospital Episode Statistics and ONS data will be undertaken. In this project, the research team will review the incidence of oesophageal squamous cell cancer or oesophageal adenocarcinoma following head and neck cancer or lung cancer from routine primary care data and identify whether a cohort of such patients would potentially benefit from endoscopic screening. The incidence of oesophageal squamous cell cancer and oesophageal adenocarcinoma can then be calculated in patients with a previous head and neck cancer or lung cancer diagnosis over a 15 year time frame. These will be compared to incidences in controls (matched for age, sex and practice) without lung or head and neck cancer diagnoses. Cox regression analyses will then be used to examine associations with patient age, smoking status, index cancer type and treatment received for the cancer such as radiotherapy.Outputs
Hazard ratio of oesophageal cancers following a diagnosis of either head and neck cancer or lung cancer will be compared to controls, adjusting for patient demographics and other known risk factors. Following on from this work, if the difference in the hazards of oesophageal cancers is high (over 1%), the possible impacts of screening in this population will be studied.
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Longitudinal trends in asthma mortality and life-threatening asthma, and predictors for asthma-related deaths in children living in England — David Lo ...
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Longitudinal trends in asthma mortality and life-threatening asthma, and predictors for asthma-related deaths in children living in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-02
Organisations:
David Lo - Chief Investigator - University of Leicester
Aleksandra Gawlik-Lipinski - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Jennifer Quint - Collaborator - Imperial College London
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
Key Outcomes
Relating to longitudinal trends (descriptive analysis):
- Annual incidence of asthma-related deaths in children and young people (CYP) aged 5-21 years in the last 20 years by IMD quintile and ethnic group
- Annual incidence of life-threatening asthma attacks (defined as attacks requiring admission to ICU/HDU unit) in CYP aged 5-21 years in the last 20 years by IMD quintile and ethnic group- Annual prevalence of uncontrolled asthma (defined as â¥6 prescriptions of short acting reliever inhalers, or â¥1 course of oral corticosteroids, â¥4 courses of oral corticosteroids, or â¥1 emergency department visits with asthma, or â¥1 hospital admission with an asthma attack over a 12-months period) in CYP aged 5-21 years in the last 20 years by IMD quintile and ethnic group
Relating to asthma care delivered (descriptive analysis):
In CYP with asthma, the proportion (%) of children who had coded evidence of the following between 2014 to the latest available linked data:
- An asthma review annually from the date of diagnosis with asthma
- Referral to secondary care if indicated (â¥2 OCS in 12 months, step 4/5 asthma treatment, admission to hospital with an asthma attacks, or â¥2 A&E attendances for an asthma attack in the past 12 months)
- Written PAAP
- Inhaler technique check
- ICS if LABA prescribed (i.e. no one should be on a LABA only)
- evidence of an asthma review within 2 working days of an asthma attack requiring treatment in an emergency care setting
- documentation of smoking or smoke exposureRelating to risk factors for adverse asthma outcomes (case-control study):
- Factors associated with asthma deaths in CYP
- Factors associated with life-threatening attacks in CYPDescription: Lay Summary
Asthma is a disease affecting the airways in the lungs, usually causing wheeze, shortness of breath, chest tightness, or cough. It is estimated that 8 million people in the UK are diagnosed with asthma, of which 5.4 million actively receive treatment. The UK has one of the highest asthma death rates in children compared with other developed countries in the world. A report published 10 years ago found that the care of children and young people with asthma in the UK was poor.
Using electronic health data that has already been collected, in this study we will investigate if the care of children and young people with asthma has improved in the last 20 years, if children from certain ethnic or social backgrounds are more likely to die from their asthma, and if there are any risk factors which can predict asthma deaths and life-threatening asthma attacks.
Answering these questions will allow healthcare professionals to better recognise higher-risk children, improve their care, and hopefully prevent asthma deaths in the future.
Technical SummaryThe UK has amongst the highest asthma related mortality and hospitalisation rates in adults and children compared with other high-income countries around the world.
The UK National review of asthma deaths (NRAD) report published over 10 years ago identified worrying deficiencies in asthma care, and made a number of recommendations for improvement. The National Institute for health and care excellence (NICE) also published the first quality standards for asthma care in England in 2013.
It is unclear how the incidence of asthma deaths in children and young people (CYP) have changed since the publication of the NRAD report and NICE quality standards, whether asthma mortality in CYP disproportionately affects certain ethnic and/or socioeconomic groups more, and whether the recommendations for asthma care made by NRAD and NICE have been implemented into routine practice, specifically in CYP who have died since the recommendations were made.
Using data from the Clinical Practice Research Datalink (CPRD) linked to hospital episodes statistics (HES), Office of National Statistics (ONS) mortality data, and the index of multiple deprivation (IMD), we will describe the longitudinal trends in incidence of CYP asthma deaths and life-threatening attacks, and prevalence of uncontrolled asthma in CYP living in England over the past 20 years, and explore whether there are observable differences between CYP from different ethnic and socioeconomic backgrounds; describe quality of asthma care benchmarked against recommendations made by NRAD and NICE, and determine risk factors associated with asthma-related deaths and life-threatening asthma attacks in children and young people.This work will allow us to describe ongoing deficiencies in asthma care and risk factors for poor outcomes, specifically in children and young people, provide evidence to lobby commissioners and decision-makers for improvements in asthma services for young people, and to improve recognition of high-risk asthma patients.
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Understanding care utilisation for people with eating disorders from minoritized groups in primary care. — Ulrike Schmidt ...
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Understanding care utilisation for people with eating disorders from minoritized groups in primary care.
Datasets:GP data, Patient Level Index of Multiple Deprivation Domains; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-22
Organisations:
Ulrike Schmidt - Chief Investigator - King's College London (KCL)
Jessica Wilkins - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Karina Allen - Collaborator - King's College London (KCL)Outcomes:
Number of contacts to primary care in 24 months prior to diagnosis of eating disorder (ED) or referral to a specialist ED service; Amongst people with ED do demographic factors (e.g. ethnicity, BMI) impact number of contacts to primary care prior to referral/diagnosis; matching on age, sex and index date, does number of contacts differ significantly for patients with/without ED.
Description: Lay Summary
Eating disorders (EDs) are serious mental illnesses that can lead to mental and physical health problems, including a higher risk of death. Many people with EDs are unwell for a long time before treatment, usually between three to six years. Long periods of illness without treatment can lead to worse outcomes, including symptoms which last longer or need more intensive help. While EDs affect people from all backgrounds, some have a harder time getting diagnosed and treated. For example, people from ethnic minorities are less likely to be referred for ED treatment. Most people with an ED will visit a primary care doctor, either to be referred to a specialist or for physical symptoms related to their ED. We want to see how people use primary care in the two years before their ED is identified, focusing on people from ethnic minority groups in the U.K. By learning how people with EDs ask for help from primary care we can help people get to treatment more quickly. If ethnic minority groups have different paths to ED diagnosis or referral compared to white patients, this can show where to improve support for both primary care doctors and patients to improve access to care.
Technical SummaryEating disorders (EDs) are serious mental illnesses which occur across all race and ethnic groups although people from ethnic minority groups are under-served in ED research. In the U.K., people with EDs may have contact with primary care services because they need a referral to access specialist treatment or because of needing help with physical consequences of their ED. This makes primary care data useful in understanding ED among those who may or may not have sought a referral for ED specialist treatment.
The overall objective of this study is to understand how people with EDs use primary care services. Specifically, we aim to:
1. Identify whether ethnic minority status affects the number of primary care visits in the 24 months before ED diagnosis or referral to a specialist.
2. Determine if people with EDs have more primary care visits in the previous 24 months compared to non-ED patients, while controlling for age, sex, and practice area.
3. Assess if demographic variables influence whether a person presenting to primary care is referred for specialist ED treatment.
Using CPRD Aurum database, the study population will include patients aged 16-65 years with a diagnosis of any ED or a referral to an ED service between 01/01/2010 to 31/12/2023. We will use Poisson analysis of variance (ANOVA) to assess the frequency of primary care contacts over the 24 months before ED diagnosis or referral, comparing groups by ethnicity and between ED and non-ED patients. Additionally, Pearsonâs chi-squared tests will be used to assess the proportion of patients with an ED diagnosis who are referred for specialist ED care, categorized by ethnicity and BMI. Understanding how people with ED are presenting to primary care can offer insight into how people seek help for eating problems and ultimately improve access to treatment.
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Evaluating the quality, safety and effectiveness of switching patients from pressurised metered dose inhalers to dry power inhalers for the treatment of asthma and COPD — Anita McGrogan ...
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Evaluating the quality, safety and effectiveness of switching patients from pressurised metered dose inhalers to dry power inhalers for the treatment of asthma and COPD
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-03
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Matthew Jones - Corresponding Applicant - University of Bath
Aleksandra Howell - Collaborator - University of Bath
Nan Zhou - Collaborator - University of Bath
Patric Boardman - Collaborator - University of BathOutcomes:
Quality measures:
⢠Persistence with switch;
⢠How many people switch their inhaler;
⢠How do people switch and do they have an appointment or training in the inhaler technique;
⢠Which drugs do people switch to;
⢠Carbon dioxide equivalent savings;
Safety and effectiveness measures:
⢠Salbutamol prescribing;
⢠Antibiotic prescribing (asthma cohort);
⢠Healthcare appointments;
⢠Treatment step ups;
⢠Admissions to hospital;
⢠Exacerbations, including oral corticosteroid use;
⢠Symptom scores (COPD Assessment Test [CAT], Asthma Control Test [ACT], Asthma Control Questionnaire [ACQ] where recorded).Description: Lay Summary
The most common type of inhaler used by patients with asthma or COPD (chronic obstructive pulmonary disease) is called a pMDI. When pMDIs are used, they release strong greenhouse gases. Therefore, the NHS is trying to use fewer pMDIs and more of a different type of inhaler, known as DPIs. GP surgeries have been asked to change patients from pMDIs to DPIs where appropriate. However, these inhalers need to be used in different ways. If a patient uses their new DPI incorrectly, their asthma or COPD will not be treated as well. There has been little research into what happens to patients who change from using a pMDI to a DPI.
This project will examine anonymous medical records to find people with asthma or COPD who changed from using a pMDI to a DPI. We will summarise the type of patients who make this change and which medicines they were using. We will also look at how long they continue using their new DPI and how this changes the release of greenhouse gases. We will look at whether people have more flare ups or symptoms of their asthma or COPD after changing inhalers. We will compare this with people who donât change inhalers.
The findings will show whether changing patientsâ inhalers is safe. We will also be able to suggest ways for the NHS to improve this process.
Technical SummaryThis study will identify a cohort of people with a diagnosis of asthma and a second cohort of people with a diagnosis of COPD. Eligible patients will need at least 12months of continuous stable prescribing. The type of preventer inhaler (e.g. inhaled corticosteroid, long-acting beta-agonist etc.) that the patient receives will be identified as either a pMDI or DPI. Differences in patient characteristics between those who receive a pMDI or DPI inhaler will be evaluated. The study will follow patients over time from index date and identify if the patients continue with the same type of inhaler or if this changes during the course of the study. From index date, any changes in dose, frequency or step changes in treatment level will be identified and described.
Outcomes that indicate worsening disease control will be identified: exacerbations, hospital admission, antibiotic prescribing, reliever inhaler prescribing, healthcare appointments and changes in symptom scores e.g. COPD Assessment Test, Asthma Control Test or Questionnaire that give a patient reported measure of symptom severity. For those who switch inhaler type, analyses comparing counts of prescriptions (corticosteroids, antibiotics, salbutamol) or outcomes (hospital admission, exacerbations, healthcare appointments, treatment step change) recorded in the 12months before and 12months after the switch in inhaler type will be analysed using regression analyses (linear or nonlinear as appropriate). Secondly, the comparator groups of patients who do not switch their inhaler type will be included and Cox regression with time varying covariates to account for inhaler type will be used to evaluate the first occurrence after the index date of treatment step change, hospital admission, exacerbation and corticosteroid prescription. All analyses will be adjusted for covariates.
NHS England incentives will be evaluated using interrupted time series analysis; impact on greenhouse gases will be found from inhalers prescribed and carbon dioxide equivalent savings tariffs.
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Effects of leukotriene receptor antagonists on the risk of Parkinson's in patients with asthma: a cohort study — Li Wei ...
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Effects of leukotriene receptor antagonists on the risk of Parkinson's in patients with asthma: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-22
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Chengsheng Ju - Corresponding Applicant - University College London ( UCL )
Anette Schrag - Collaborator - University College London ( UCL )
Camille Carroll - Collaborator - Newcastle University
Thomas Foltynie - Collaborator - University College London ( UCL )Outcomes:
New-onset Parkinsonâs.
The diagnosis of Parkinsonâs.in the database is defined as having one read diagnostic code for Parkinsonâs and at least two prescriptions of the anti-parkinsonian drugs (levodopa, dopamine receptor agonists, or monoamine-oxidase-B inhibitors). The date of Parkinsonâs diagnosis will be the early date of diagnosis with read codes or the date of the prescription.Description: Lay Summary
Parkinsonâs is a brain disorder causing difficulty in movement. There is no cure to Parkinsonâs yet.
Technical Summary
Asthma is a breathing problem with symptoms of wheezing.
Leukotriene receptor antagonists (LTRAs) are drugs that have been commonly used for asthma. There are preclinical data to suggest the drugs may be used to slow down the progression of Parkinsonâs, but we need more data from humans to confirm their effects. In this study, we wish to find out whether the use of LTRA drug is helpful for individuals to prevent Parkinsonâs in the real world. The best way to confirm the effect of a drug is to conduct randomised controlled trials. However, these trials are extremely expensive and time-consuming. As a solution, we will design randomised controlled trials and emulate these trials using readily available observational electronic healthcare data. We will compare LTRA drug with no LTRA drug in patients with asthma to find out whether the drug can prevent Parkinsonâs. This study will provide valuable evidence to support the explorations of new therapies for treating Parkinsonâs.Parkinsonâs is a progressive neurological condition with no disease-modifying treatment available.
Leukotriene receptor antagonists (LTRAs) is commonly used drugs indicated for asthma or allergic rhinitis. Preclinical studies showed that these drugs may be neuroprotective by reducing microglial activation and α-synuclein load. There is however a lack of epidemiological evidence from the real world that these drugs might reduce the risk of Parkinsonâs. In this study, we will evaluate the effect of LTRA on prevention of Parkinsonâs.
We will use the CPRD database from 2000 to 2023. We will emulate target pragmatic trials comparing LTRA treatment versus no treatment on the risk of new-onset Parkinsonâs. We will include patients aged 45 to 79 years between 2000 to 2021, without prior Parkinsonâs, dementia, or levodopa treatment. We will use a sequential nest trial emulation approach, thereby, we will emulate multiple trials starting at different ages (from 45 to 79 years). In total, 35 trials will be emulated. Patients will be categorised according to comparable treatment strategies during the baseline year, and all patients will be followed from the start of that trial until outcomes (incident Parkinsonâs) or loss-to-follow-up. The study outcome will be a diagnosis of new-onset Parkinsonâs. LTRA treated patients will be rolling matched to non-treated patients at 1:1 ratio based on propensity score within each trial. We will estimate both observational analogues of the intention-to-treat effect and per-protocol effect.
We will use primary care data to ascertain use of medications, primary care data and HES data to ascertain medical conditions, ONS data to ascertain death, and patient-level IMD data to ascertain socioeconomic classes.
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Assessing cardiac disease morbidity and long-term outcomes in pregnancy: a population-based cohort study using the Clinical Practice Research Datalink — Marian Knight ...
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Assessing cardiac disease morbidity and long-term outcomes in pregnancy: a population-based cohort study using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-12
Organisations:
Marian Knight - Chief Investigator - University of Oxford
Ling Tao - Corresponding Applicant - University of Oxford
Aden Kwok - Collaborator - University of Oxford
Joris Hemelaar - Collaborator - University of Oxford
Rema Ramakrishnan - Collaborator - University of OxfordOutcomes:
Incidence and prevalence of maternal cardiac disease including congenital heart disease, pulmonary hypertension, thoracic aortic disease, acquired valvular heart disease, coronary artery disease/ischemic heart disease, cardiomyopathy, myocarditis, heart failure, and arrhythmia.
The long-term outcomes of maternal cardiac disease that will be examined are: cardiovascular events including cardiac events, vascular events, cerebrovascular events, and all-cause and cardiovascular death.
Description: Lay Summary
This research aims to learn about how common heart conditions are among pregnant and postpartum women and what happens afterward. By gathering this information, we can better understand the health of pregnant women and plan ways to help. Ultimately, this could lead to fewer health problems for pregnant women in England.
Technical Summary
Here are the questions this research will explore:
1. How many pregnant and recently pregnant women have a diagnosis of heart disease?
2. How many women are diagnosed with heart disease during pregnancy or up to one year after the end of pregnancy?
3. What are the long-term heart-related issues among women diagnosed with heart disease before or during pregnancy or up to one year after the end of pregnancy?
4. What is the risk of having further heart-related issues among women diagnosed with heart disease before or during pregnancy or up to one year after the end of pregnancy?
To answer these questions, we'll analyse the health records of women who were pregnant between 2000 and 2023 in England from the Clinical Practice Research Datalink (CPRD).This study aims to fill the gap in knowledge regarding the morbidity and natural history of maternal cardiac disease, generating essential data for future health economic analysis to guide intervention policies. This could ultimately lead to a decrease in maternal morbidity and mortality, benefiting women in England.
The research questions are as follows:
1. What is the prevalence of maternal cardiac disease, total and by each subtype, in England?
2. What is the incidence maternal cardiac disease, total and by each subtype, in England, both during the study period and in each trimester or postnatal period?
3. What are the trajectory patterns of cardiovascular events among pregnant women with and without cardiac disease?
4. What is the risk of cardiovascular events over the long term among pregnant women with and without cardiac disease?
The proposed study is a retrospective cohort study of women who were pregnant between 2000 and 2023 in England, and are included in CPRD Aurum. Data from CPRD Aurum will be linked to data from Hospital Episode Statistics (HES), the Office for National Statistics (ONS), small area level data, and pregnancy register. Descriptive analysis will be performed to calculate the prevalence and incidence of maternal cardiac disease. Trajectory patterns of cardiovascular events will be identified. Multivariable Cox model and recurrent time-to-event model will be used to assess the likelihood of experiencing cardiovascular events in these women.
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Sickness absence in the working age population in England before and during the COVID-19 pandemic: a retrospective cohort study using primary care medical certificate data — Shamil Haroon ...
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Sickness absence in the working age population in England before and during the COVID-19 pandemic: a retrospective cohort study using primary care medical certificate data
Datasets:GP data, Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-09
Organisations:
Shamil Haroon - Chief Investigator - University of Birmingham
Naijie Guan - Corresponding Applicant - University of Birmingham
James Rockey - Collaborator - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Louise Jackson - Collaborator - University of Birmingham
Mark Monahan - Collaborator - University of Birmingham
Tom Marshall - Collaborator - University of Birmingham
Tracy Roberts - Collaborator - University of BirminghamOutcomes:
Primary outcome: Medical certificates issued for sickness absence of any cause, referred to throughout the protocol as âfit notesâ. These will be defined using SNOMED-CT codes for sickness certification (also known as Statement of Fitness for Work or Med 3 Form). We will be excluding SNOMED-CT codes indicating that an individual may be able to work.
Secondary outcome: Economic loss associated with sickness absence. We will use the IMD income domain data associated with each patient to estimate the cost of their periods of sickness absence.
Description: Lay Summary
Medical certificates, also known as fit notes or sick notes, are important documents issued by healthcare professionals (e.g., doctors, nurses, etc) to explain how an individualâs health condition may limit their ability to work. Changes in how these fit notes are issued and why can help us understand health trends in society over time, spot public health issues and thus decide where to prioritise resources. There is currently a lack of research investigating the issuing of fit notes in primary care, especially in the context of significant medical, psychological, social and economic change due to public health events like the COVID-19 pandemic.
Our study aims to look at the fit notes issued to the working-age population (aged between 18 and 65) and the economic costs associated with being off work, both before and during the latter part of the COVID pandemic, using primary care medical certificate data. We will also explore if the rate of fit notes issued varies by different patient-related factors like age, sex, ethnicity, poverty, smoking, body mass index (including obesity), health condition, number of consultations, and region. Finally, we will investigate which health problems cause most of the sickness absence in the working-age population. This study will inform public health planning and policy making, ensuring we are better prepared for the transition in sickness absence in the post-pandemic era and for potential future pandemics.
Technical SummaryPeople have experienced significant medical, psychological, social, and economic changes since the COVID-19 pandemic including changes to working practices. There is little research on sickness absence in the UK working-age population using healthcare record data and the picture of how sickness absence has changed following the COVID-19 pandemic is still unclear, indicating a significant research gap. This study aims to explore all-cause sickness absence (as measured by fit notes: official medical certificates issued by health professionals in the UK to indicate an individual's inability to work due to sickness after 7 days of sickness absence) among the working-age population (aged between 18 and 65) in England before and during the latter part of the COVID-19 pandemic. This retrospective cohort study will use healthcare record data from a large primary care database, CPRD Aurum, covering the period both before the COVID-19 pandemic (from 1st January 2017 to 31st December 2019) and during the latter part of the pandemic (from 1st March 2022 to 28th February 2023). The four objectives are: 1) to quantify the rate of fit notes issued before and during the latter part of the COVID-19 pandemic, including in population subgroups; 2) to estimate the independent association between sociodemographic and health-related factors and sickness absence in both periods using multivariable Poisson regression models; 3) to explore the main causes of sickness absence in the working age population in England by using the diagnostic codes recorded at the time of or prior to the date when fit notes were issued; 4) to quantify the economic loss associated with sickness absence. Understanding sickness absence and changing trends over time will offer important insights into the general health and wellbeing of the working-age population, of high relevance to policy makers, employers, insurers, and healthcare planners and providers.
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Transient use of oral corticosteroids and the risk of acute severe adverse events among asthma patients: a population-based real-world study — Samy Suissa ...
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Transient use of oral corticosteroids and the risk of acute severe adverse events among asthma patients: a population-based real-world study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-15
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Jiaying Li - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill UniversityOutcomes:
Pneumonia; sepsis; gastrointestinal (GI) bleeding; cardiovascular events (myocardial infarction, heart failure, and atrial fibrillation); psychosis/delirium; and acute complications of diabetes (hyperosmolar coma or diabetic ketoacidosis), all requiring hospitalization.
Description: Lay Summary
Asthma is a chronic respiratory disease with frequent flare ups that worsen symptoms and reduce breathing capacity. These are usually treated with short courses of oral corticosteroids (OCS), along with asthma inhalers. Studies of other diseases, mainly in older patients, have shown that OCS can lead to heart attacks, high blood sugar or diabetes, stomach complications, and infections. However, such studies in asthma are scarce and many asthma patients are younger. Since OCS are given to most asthma patients for brief periods to treat the flare-ups, we will assess if short-term use of OCS in patients with asthma can trigger these complications.
Our research will use a technique that compares patients to themselves by measuring if the adverse event occurs more frequently when the patient is taking the drug compared to when they are not. We propose a study using electronic health data from the UKâs Clinical Practice Research Datalink (CPRD) to form a cohort of patients with asthma. This cohort will be used to examine if short-term OCS use causes lung or blood infections, gastrointestinal bleeding, heart attacks, heart failure, heart arrythmia, psychosis or delirium, and complications related to blood sugar control in asthma patients. This work will advance our knowledge on the safety of OCS use among asthma patients and promote safer clinical practice.
Technical SummaryAsthma is a global health concern with increasing prevalence. Asthma exacerbations occur on average 2-3 times yearly among patients with mild-to-moderate asthma, often treated with short-term (3-14 days) oral corticosteroids (OCS). Regular OCS use in other diseases has been associated with several adverse events, but only one study has investigated these risks in asthma patients. This study did not focus specifically on short-term OCS use and had important methodologic limitations like immortal time and selection biases. We propose to conduct an epidemiological study to investigate the safety of OCS for asthma using a design that minimizes these biases. This project aims to assess the risk of several acute adverse events after transient OCS use among patients with mild-to-moderate asthma.
The United Kingdomâs Clinical Practice Research Datalink (CPRD) will be our data source. Specifically, the ONS Death Registration Data will be used to identify death records and the HES Admitted Patient Care data will provide information on outcome events of interest, all requiring hospitalization. Health records in CPRD have been shown to be accurate and valid. We will first identify a base cohort with all patients first diagnosed with asthma from 2000-2022, who have at least one year of record prior to first asthma diagnosis. Our primary approach will be a case-crossover design where, for a given outcome under study, those who experienced the outcome will be identified from the base cohort and their OCS exposure at the time of the event (i.e. during risk periods) will be compared to their OCS exposure during prior baseline periods. Conditional logistic regressions will be used to account for the correlation between baseline and risk periods contributed by the same individuals. Our research will inform safer clinical practice when treating acute exacerbations among patients with mild-to-moderate asthma, including those from the United Kingdom.
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The relationship between blood pressure variability, adherence to antihypertensive medications and major adverse cardiovascular events in a multi-ethnic population: a United Kingdom Clinical Practice Research Datalink Cohort Study — Patrick Highton ...
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The relationship between blood pressure variability, adherence to antihypertensive medications and major adverse cardiovascular events in a multi-ethnic population: a United Kingdom Clinical Practice Research Datalink Cohort Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-12
Organisations:
Patrick Highton - Chief Investigator - University of Leicester
Patrick Highton - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Samuel Seidu - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
⢠Blood pressure control
⢠Prevalence and severity of medium and long-term BPV
⢠Prevalence and severity of non-adherence to antihypertensive medications
⢠Impact of socioeconomic and clinical factors on BPV and medication adherence
⢠CVD events and mortality risk in those with hypertension, and based on socioeconomic and clinical factors, and degree of BPV and medication non-adherenceDescription: Lay Summary
People who take medications to lower their blood pressure often struggle to take these medications regularly; this is called medication non-adherence. This can be due to a variety of reasons, including being on multiple drugs, worries about side effects or forgetfulness. This may also cause their blood pressure to vary over time and may not be controlled. This means that these people may be at higher risk for future heart problems (such as heart attacks or strokes), and also that medications are being wasted, which is expensive for the NHS.
Technical Summary
People from UK ethnic minority populations are at high risk for medication nonadherence due to a variety of poorly-understood causes including poor doctor-patient communication, differing cultural beliefs and problems cultural reasons, understanding medical terms. Additionally, people with long-term conditions in addition to high blood pressure (such as diabetes and heart disease), are at high risk for medication non-adherence due to problems managing several conditions at once. As such, people with multiple conditions from ethnic minority groups are likely at very high risk for increased blood pressure variability, high uncontrolled blood pressure, medication non-adherence and future heart problems, but this is under-researched.
Therefore, the aim of this research will be to investigate patterns of blood pressure variability and non-adherence to blood pressure medications in those with multiple long-term heart or metabolic (e.g. diabetes) conditions and in a diverse population (including different ethnic groups and socioeconomic groups), and how they impact long term outcomes such as major heart disease events.Hypertension is the leading risk factor worldwide for cardiovascular disease (CVD) and premature death. In those with multiple long-term conditions (MLTCs, or multimorbidity), hypertension is the most common co-morbidity (18.2%). In the UK, hypertension is significantly more prevalent in ethnic minority populations, and these populations may also not achieve post-diagnosis blood pressure control comparable to that of their white counterparts. Consequently, certain ethnic minority populations, including South Asian and Black populations, are at greater CVD risk than Europeans. CVD prevention is therefore vital in these groups.
Hypertension is managed with antihypertensive medications, which have reduced BP globally. However,
non-adherence to medication, defined as not taking a medication as prescribed, is highly prevalent in
people with hypertension, and is a key cause of uncontrolled BP and driver of CVD events and mortality. Antihypertensive medication non-adherence may also drive increases in blood pressure variability (BPV) when measured on both medium-term (visit to visit) and long-term (months/years) bases. Elevated BPV has also been associated with increased risk of adverse cardiovascular events.Therefore, we aim to investigate patterns of BP control, BPV and antihypertensive medication non-adherence in a diverse population with MLTCs, and how they impact major adverse cardiovascular events. We will do this by: estimating the degree of BPV in those with cardiometabolic MLTCs, using medium-term (visit-to-visit) and long-term (months/years) BPV measurements; estimating the degree of non-adherence to antihypertensive medications in this population, and the association between medication adherence status and BPV; assessing BPV and adherence rates in different socioeconomic groups (by ethnicity, age, sex, socioeconomic status), and based on MLTC status (hypertension only vs additional concurrent cardiometabolic MLTCs); investigating whether differences in BPV and/or adherence to antihypertensive medication drives adverse cardiovascular outcomes; and investigating whether the impact of BPV and non-adherence on CVD event rates differ by ethnicity or MLTC status.
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Determining the incidence and prevalence of pulmonary hypertension associated with common respiratory and cardiovascular comorbidities in the UK — Jennifer Quint ...
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Determining the incidence and prevalence of pulmonary hypertension associated with common respiratory and cardiovascular comorbidities in the UK
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-30
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Allan Lawrie - Collaborator - Imperial College LondonOutcomes:
Incidence of PH (of any aetiology) new diagnoses per million person-years
Prevalence of PH (of any aetiology) cases per million population (adult)Incidence of PH associated with left heart disease (WHO Group 2) new diagnoses per million person-years
Prevalence of PH associated with left heart disease (WHO Group 2) cases per million population (adult)Incidence of PH associated with chronic lung disease (WHO group 3) new diagnoses per million person-years
Prevalence of PH associated with chronic lung disease (WHO Group 3) cases per million population (adult)Description: Lay Summary
Pulmonary hypertension (PH) is a rare but potentially life-threatening condition that affects the blood vessels in the lungs. It develops when the pressure in the blood vessels of the lung is higher than normal. This causes the heart to work harder, which over time can damage the right side of the heart. In severe cases, pulmonary hypertension can lead to death from heart failure within a few years.
Technical Summary
While pulmonary hypertension can develop on its own, it more commonly occurs alongside other diseases, including other lung and heart conditions. People who develop pulmonary hypertension alongside other heart and lung diseases - such as left-sided heart failure and chronic obstructive pulmonary disease - are more likely to die at an earlier age than those who have pulmonary hypertension alone.
UK hospital-based data suggest that around 8,000 people develop pulmonary hypertension each year. However, because the condition is often difficult to diagnose and not everyone with pulmonary hypertension is referred to a specialist clinic for treatment, we suspect the actual number of people affected is much higher. This is especially true of people who have pulmonary hypertension with other heart and lung diseases. The aim of this study is to get more accurate information on the numbers of people who fall into this category so that we can design health services that better meet their needs.Pulmonary hypertension (PH) describes a heterogeneous population of patients who have a mean pulmonary arterial pressure greater than 20 mmHg. While PH can present as a primary disorder (i.e. idiopathic pulmonary arterial hypertension (iPAH)), it more commonly occurs as part of a complex phenotype associated with other diseases and conditions, including cardiovascular and respiratory comorbidities. Traditionally, and to serve as a guide to treatment, PH has been categorised by WHO into five groups based on the underlying aetiology. While there has been some work undertaken to determine how idiopathic pulmonary arterial hypertension is coded in routine healthcare data, this has been done using hospital as opposed to primary care data. Moreover, few if any studies have explored how other the types of pulmonary hypertension are coded in routine primary care data. Using CPRD Aurum linked with HES APC data, we will develop various algorithms to elucidate how to most accurately determine whether someone has a diagnosis of PH associated with cardiovascular or respiratory diseases (WHO PH Groups 2 and 3). We will then determine the incidence and prevalence of PH overall and by subgroup and how this has changed over time in England.
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Association of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists with multisystem manifestations, hospitalization, and all-cause mortality — Krishnarajah Nirantharakumar ...
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Association of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists with multisystem manifestations, hospitalization, and all-cause mortality
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-30
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Jingya Wang - Corresponding Applicant - University of Birmingham
Megha Singh - Collaborator - University of BirminghamOutcomes:
Outcomes consist of a set of multisystem manifestations, hospitalization, and all-cause mortality during the follow-up period. Multisystem manifestations including 105 systemic diseases across 17 organ systems:
1) Cardiovascular disease: hypertension, heart failure, atrial fibrillation, stroke, ischaemic heart disease/ coronary artery disease, peripheral vascular disease, heart valve disorders, cardiomyopathy, venous thromboembolism, and aortic aneurysm
2) Metabolic and endocrine disorders: hypothyroidism, hyperthyroidism, and Addisonâs disease
3) Kidney disease: chronic kidney disease (stage 3-5), nephrolithiasis, and urolithiasis
4) Liver disease: alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, chronic liver disease, cirrhosis, hepatitis B/C, and autoimmune liver disease
5) Gastroenterological disease: inflammatory bowel disease, irritable bowel syndrome, peptic ulcer, gallstones/cholelithiasis, pancreatitis, and chronic constipation.
6) Respiratory disease: asthma, chronic obstructive pulmonary disease, obstructive sleep apnoea, interstitial lung disease, pulmonary hypertension, bronchiectasis, and cystic fibrosis
7) Musculoskeletal/ rheumatological disease: osteoporosis, osteoarthritis, rheumatoid arthritis, gout, systemic lupus erythematosus, Sjogren's disease, systemic sclerosis, psoriatic arthritis, polymyalgia rheumatic/giant cell arteritis, fibromyalgia/chronic fatigue, and chronic back pain
8) Haematological disease: primary thrombocytopenia, haemophilia, pernicious anaemia, iron deficiency anaemia, and megaloblastic anaemia
9) Urinary disease: urolithiasis, prostatic hyperplasia, female urinary incontinence, and recurrent or urinary tract infection
10) Sensory disability: vision impairment, hearing impairment, cataract, glaucoma, age-related macular degeneration, and Meniereâs disease
11) Mental health conditions: depression, anxiety, bipolar disorder, eating disorder, drug/alcohol misuse, schizophrenia, personality disorder, dissociative disorders, and obsessive-compulsive disorder
12) Neurological disease: dementia, Parkinson's disease, epilepsy, multiple sclerosis, peripheral neuropathy, migraine, other headaches
13) Cancer: Colo-rectal cancer, breast cancer, uterine cancer, prostrate cancer, lung cancer, haematological cancers, lymphomas, and other cancers
14) Gynaecological disease: polycystic ovarian syndrome, fibroids, female infertility, endometriosis
15) Andrological disease: erectile dysfunction and male infertilityã
16) Dermatological disease: eczema, psoriasis, vitiligo, alopecia areata, seborrheic dermatitis, rosacea, hidradenitis suppurativa, and lichen planus
17) Diabetic complications: diabetic retinopathy, diabetic foot, amputation, diabetic kidney disease, and diabetic ketoacidosisDescription: Lay Summary
Type 2 Diabetes, a condition that has trouble regulating the amount of sugar (glucose) in the blood, affecting one in ten adults worldwide, and it's linked to many health problems like cardiovascular diseases (conditions affecting heart/blood vessels), cancers (a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body), and kidney diseases (characterized by kidneys are damaged and can't filter blood the way they should). Among nine glucose-lowering medication classes, there are three commonly used second-line medications in practice: sodium-glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1(GLP-1) receptor agonists, and dipeptidyl peptidase-4 (DPP-4) inhibitors. These medications have been demonstrated to have potential benefits for several long-term health conditions, such as cardiovascular disease, nephrolithiasis (kidney stones) and so on. However, it is still unclear that how those medications affect overall health besides controlling blood sugar. To find out the answer, we plan to compare the risk of 105 diseases, hospitalization, and all-cause mortality between (i) SGLT2 inhibitors and (ii) GLP-1 receptor agonists against DPP-4 inhibitors among people with type 2 diabetes. This research is all about understanding how these three glucose-lowering medicines affect overall health in a systematic way, so healthcare providers can make better choices for patients and help them stay healthier in the long run.
Technical SummaryAims:
To investigate the association of the use of SGLT2 inhibitors or GLP1 receptor agonists with the subsequent risk of multisystem manifestations, hospitalization, and all-cause mortality, compared to DPP4 inhibitors.Methods:
We will perform two open cohort studies using new-user design to investigate the effects of SGLT2 inhibitors or GLP1 receptor agonists separately. Propensity score fine stratification weighting will be applied to create a pseudo-comparator group with similar characteristics as the exposed group. Competing risk Cox proportional hazard regression models will be used to calculate crude hazard ratios (crude HRs) and adjusted hazard ratios (adjusted HRs) of intention-to-treat and per-protocol effects, together with their corresponding 95% CIs. Death during the follow-up period will be treated as a competing event for non-fatal outcomes.Outcomes:
Outcomes consist of a set of multisystem manifestations (105 systemic diseases across 17 organ systems), hospitalization, and all-cause mortality during the follow-up period.Exposures:
Prescription of SGLT2 inhibitors in SGLT2 Cohort and prescription of GLP1 receptor agonists in GLP1 Cohort.Participants:
Individuals with a diagnosis of type 2 diabetes aged 40 years and over who received at least one antidiabetic agent will be eligible for this study. All participants must have been registered with the general practice for at least one year before the index date (start of follow-up).Covariates:
Sociodemographic characteristics, behavioural risk factors, diabetes-related characteristics, comorbidities, biomarkers, and drug prescriptions will be adjusted to account for residual confounding.Intended public health benefits:
If the effect of SGLT2 inhibitors and GLP1 agonists on the subsequent risk of multisystem manifestations, hospitalization, and all-cause mortality is confirmed, it might facilitate decision-making in a systematic way when prescribing glucose-lowering agents for patients with type 2 diabetes in everyday practice.
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Understanding the Epidemiology and the Risk of Developing Specific Mental Health Conditions among Children and Young People (CYP) Subsequent to Cancer Diagnosis — Darren Ashcroft ...
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Understanding the Epidemiology and the Risk of Developing Specific Mental Health Conditions among Children and Young People (CYP) Subsequent to Cancer Diagnosis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-17
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Moe Zandy - Corresponding Applicant - University of Manchester
Claire Higham - Collaborator - The Christie NHS Foundation Trust
Louise Robinson - Collaborator - Central Manchester University Hospitals
Martin McCabe - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Shruti Garg - Collaborator - University of ManchesterOutcomes:
Outcomes to be Measured
1. Psychiatric conditions, including
- Depression
- Anxiety disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive compulsive disorder (OCD)
- Bipolar disorder
- Personality disorders
- Schizophrenia-spectrum disorders
- Severe mental illness
- Eating disorders2. Neurodevelopmental conditions, including
- Autism spectrum disorder (ASD)
- Attention-deficit/hyperactivity disorder (ADHD)3. Non-fatal self-harm and death by suicide
Description: Lay Summary
Children and young people diagnosed with cancer experience many challenges, affecting not just their bodies but also their feelings and mental health. While not all children and young people with cancer will develop mental health problems, some do. It's important to understand the kinds of mental health issues they might have to optimise healthcare delivery. Studies show that children and young people with cancer are more likely to have problems like feeling anxious, sad, having trouble with attention, or being on the autism spectrum. We don't fully understand factors linked with why children and young people have these problems, but things like gender, ethnicity, how much money a family has, and the type of cancer they have might play a role.
We plan to examine patientsâ electronic health records, determine if children and young people with cancer are more likely to have mental health issues than their brothers and sisters and other children and young people without cancer. We also want to figure out what things might make these mental health problems more likely, see how they change over time, and see if the COVID-19 pandemic has made things worse for them in terms of needing help with their mental health. A better understanding of psychological outcomes such an anxiety or depression and related factors such as gender and ethnicity will inform clinical care of patients diagnosed with cancer.
Technical SummaryDespite the high burden of poor mental health outcomes among CYP diagnosed with cancer, a limited number of population-based research describe the epidemiology and related risk factors for poor mental health outcomes in this group. The potential risk of poor mental health outcomes among CYP diagnosed with cancer in relation to sex, socioeconomic factors, ethnicity, urbanicity, late effects such as and concurrent chronic conditions is poorly understood. Furthermore, there is limited understanding of the pattern of poor mental health outcomes post cancer diagnosis, and the impact of the COVID-19 pandemic.
We plan to utilise CPRD Aurum's interlinked primary and secondary care records, hospitalisation data, mortality data, deprivation data, and rural-urban classification data. The Mother-Baby Database will also be used to identify siblings of CYP diagnosed with cancer. Ethnicity record linkage will enable us to investigate potential ethnic disparities. Baseline characteristics will be presented as frequencies and percentages for categorical variables. We will apply s Fine-Gray proportional sub-distribution regression model to estimate the overall cumulative incidence values at different time increments post cancer diagnosis. Cumulative incidence values will be stratified by age, sex, cancer diagnostic type, etc. Incidence density rates per 1,000 person-years will also be calculated. Furthermore, we will fit a Fine-Gray proportional sub-distribution regression model to estimate hazard ratios (HRs) for poor mental health outcomes and corresponding 95% confidence intervals, with time since cancer diagnosis as an underlying time scale, controlling for an array of important risk factors such as gender, ethnicity, etc. This will allow us to quantify the risk of adverse outcomes among CYP diagnosed with cancer compared to siblings and age-, sex-, and general practice-matched comparator groups from the general population. Finally, to quantify temporal trends of risk over time, we will stratify HR estimates by duration of follow-up.
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Cardiovascular risk estimation and statin adherence; an historical cohort study — Samuel Finnikin ...
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Cardiovascular risk estimation and statin adherence; an historical cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-04
Organisations:
Samuel Finnikin - Chief Investigator - University of Birmingham
Samuel Finnikin - Corresponding Applicant - University of Birmingham
Brian Willis - Collaborator - University of Birmingham
Rani Khatib - Collaborator - University of Leeds
Tim Evans - Collaborator - Public Health England
Tom Marshall - Collaborator - University of BirminghamOutcomes:
Statin prescriptions, other lipid lowering therapy prescriptions, Cardiovascular events (myocardial infarction, ischaemic stroke, TIA, angina, peripheral vascular disease), deaths, lipids
Description: Lay Summary
Statins are the most widely used medications in the UK and they are primarily used to reduce the risk of heart attacks and strokes. However, we know that often people do not take or continue statins once they are prescribed despite them being a long-term medication. Helping people adhere to preventative medication is an important part of keeping the population healthy. We know that when people are deciding whether to take medication or not, they should be guided through the decision using an approach called 'shared decision making' where the risks and benefits are fully discussed. To do this, clinicians should use an estimate of the patients risk of having a heart attack or stroke to help explain the potential benefits that the patient may get from the medication.
Technical Summary
Previous research has shown that some people are started on a statin without having a risk estimate undertaken, which means that they will not have had a full conversation about the risks and benefits. We aim to find out if people are more likely to continue to take statins if they have a risk score in the electronic patient record to test the theory that better shared decision making is associated with improved medication adherence. Demonstrating this link would emphasise the importance of shared decision making and focus efforts on ensuring all patients get the opportunity to have good quality discussions when considering starting medication.Adherence to statins for the primary prevention of cardiovascular disease (CVD) is known to be low despite their proven efficacy and good tolerability. All medical decisions should be made using shared decision-making (SDM) principles where the risks and benefits of the available options are fully discussed before the patient makes their decision. However, many people initiated on statins do not have a cardiovascular risk estimate (QRISK2 score) calculated prior to initiation making fully informed shared decision making unlikely.
It is hypothesised that involving patients fully in medical decisions through SDM would improve adherence to the subsequent course of action and this SDM should be associated with better medication adherence. Unfortunately, SDM is difficult to measure and so testing this theory is problematic. We propose that the presence or absence of a QRISK2 score prior to statin initiation could act as a proxy for the degree of SDM taking place and therefore may impact on adherence.
To test this, we will create a cohort of patients initiated on statin for the primary prevention of cardiovascular disease using routinely collected primary care data. Looking at the presence of a coded QRISK2 score in the 60d prior to (and including) the date of initiation, we will split the cohort into patients with and patients without QRISK2 score use during their statin initiation. All subsequent statin prescriptions over a maximum of 5-years of follow up will be examined to investigate the association between QRISK2 scoring and statin adherence (defined as a mean possession ratio of >0.8) and persistence using multivariable logistic regression and Cox regression techniques. Further Cox regression will also be undertaken to investigate whether there is any relationship with developing CVD or subsequent death which may be mediated by improved statin adherence.
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The effect of marketed drugs on incident knee and hip osteoarthritis: a population-based cohort study — Arief Lalmohamed ...
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The effect of marketed drugs on incident knee and hip osteoarthritis: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-24
Organisations:
Arief Lalmohamed - Chief Investigator - Utrecht University
Arief Lalmohamed - Corresponding Applicant - Utrecht University
Bart Van den Bemt - Collaborator - Sint Maartenskliniek
Calin Popa - Collaborator - Sint Maartenskliniek
Cornelia (Els) Van den Ende - Collaborator - Sint Maartenskliniek
Michelle Heijman - Collaborator - Sint Maartenskliniek
Patrick Souverein - Collaborator - Utrecht UniversityOutcomes:
First recorded diagnosis of knee osteoarthritis or hip osteoarthritis.
Description: Lay Summary
Degenerative joint disease is one of the leading causes of pain and disability among adults worldwide. In the United Kingdom, around 8.5 million people suffer daily from the consequences of this disease and it is estimated that this number, together with its costs, will continue to rise in the future. Since current treatment options cannot slow or alter the progression of degenerative joint disease, a substantial challenge to healthcare systems is posed. Consequently, it remains crucial to discover effective therapies that can interfere with the development of degenerative joint disease. Exploring new therapeutic uses for existing drugs could provide efficient opportunities.
Therefore, this study aims to investigate existing drugs that hold the potential to be used for the treatment of degenerative joint disease. The objectives are to examine the associations of already available drugs (including those commonly used for the prevention of hip fracture, treatment of painful joints and diabetes) with incident degenerative hip or knee disease.
In this retrospective cohort study, patients aged 18 years and over and diagnosed with the condition(s) the treatment is used for (i.e. those at increased risk of sustaining a hip fracture, painful joints and diabetes) will be included. The risk of incident degenerative knee or hip disease will be estimated and the influence of the duration of treatment will be assessed.
Technical SummaryOsteoarthritis is one of the leading causes of pain and disability among adults worldwide. Management of osteoarthritis focusses on the reduction of pain and optimalisation of function, but no disease modifying osteoarthritis drugs are currently available. Drug repurposing offers an intriguing opportunity as it is an efficient strategy to provide new treatment options.
Therefore, this study aims to investigate promising marketed drugs that hold the potential to be repurposed for the treatment of osteoarthritis. The objectives are to examine the associations of bisphosphonates, colchicine, allopurinol, and metformin with incident knee or hip osteoarthritis.
For this purpose, patients aged 18 years and over with a SNOMED code for the condition the treatment is used for between January 1987 and December 2023 will be included. Patients will be considered unexposed between the index date and the moment they have been prescribed their first prescription of treatment of interest or if they have not been prescribed treatment of interest in 12 months before the index date and have not been prescribed treatment of interest after the index date. Patients will be considered exposed the moment they have been prescribed their first prescription of the treatment of interest after the index date. The index date will be defined as the date of diagnosis of the condition the treatment is used for. The primary outcome will be the first record of knee or hip osteoarthritis after diagnosis of the condition the treatment is used for. Propensity scores will be estimated using multivariable logistic regression. A Cox proportional hazard model where propensity scores will be considered as covariate will be used to estimate hazard ratios and 95% confidence intervals. Subgroup analyses will be performed using timing of drug initiation and cessation as well as using the treatment period as a proxy for the cumulative dosage.
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Validation of proposed National Institute of Health and Care Excellence (NICE) indicator for recording of postnatal check appointments in the general population and a population with complex social factors, in primary care data. — Jonathan Wray ...
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Validation of proposed National Institute of Health and Care Excellence (NICE) indicator for recording of postnatal check appointments in the general population and a population with complex social factors, in primary care data.
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-22
Organisations:
Jonathan Wray - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Tsz Wing Vanessa Kam - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Eileen Taylor - Collaborator - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Attendance at 6 -12 week postnatal check appointment.
Description: Lay Summary
The National Institute for Health and Care Excellence (NICE) develops measures of the quality-of-care patients are receiving based on published recommendations, called indicators. These indicators are also put forward for inclusion in the Quality Outcomes Framework (QOF), which is a scheme to promote and reward good clinical practice.
An indicator has been put forward to look at how many new mothers are having a health check-up with their GP 6-to 12-months after giving birth. We will look at health checks in all new mothers, and in mothers who have difficult social circumstances.
The work proposed here will check how well the proposed indicator can be measured within general practice data. We will select a group of patients with a record of having given birth between 1st Jan 2023 and 31st December 2023. Within this group we will determine which of these women have a record of having difficult social circumstances. Across both groups, we will then report the number and proportion of patients with a record for a 6- to 12- week postnatal check in their GP data.
This provides an indicator of the percentage of women who are accessing their postnatal check appointment in both groups. Checking how well this information can be measured is very important to being able to accurately report on this group and support general practices in their work with these patient populations.
Technical SummaryThe National Institute for Health and Care Excellence (NICE) develops indicators to measure quality of care outcomes. This piece of work looks to validate the measurement of a proposed NICE indicator in primary care data. This indicator will focus on how well the data can be used to measure the recording of postnatal check appointment prevalence and attendance in the general population of patients who have given birth in the last 12 months and in the sub-population with complex social factors. This indicator is being designed as a potential QOF indicator and must therefore be measurable in primary care data.
A record of having given birth between 1st Jan 2023 and 31st December 2023 is the primary exposures that will qualify a patient for inclusion in the study, with a record of complex social factors being an additional inclusion criterion for the sub-population of interest. This is a more vulnerable population, and GPs are encouraged to ensure support is available for these patients during and after pregnancy. A retrospective cohort study design will be used, with the indicator being calculated as at 31st December 2024. CPRD Aurum primary care data will be the main data source used, with patient-level Index of Multiple Deprivation data additionally linked to stratify the indicator by deprivation quintile. This will support description of potential health inequalities within this indicator measure.
There are additional barriers to accessing and attending appropriate healthcare in the population with complex social factors and pregnant women with complex social factors may have additional needs. The measure defined here will aim to provide an indication of whether this patient population is accessing the health care they are entitled to. Targeted indicators such as this will benefit patients by focusing and incentivising good clinical practice in a specific area of clinical need.
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Comorbidities in Chronic Neurological Disorders: diagnosis, management and mortality of co-occurring conditions — Ruth Dobson ...
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Comorbidities in Chronic Neurological Disorders: diagnosis, management and mortality of co-occurring conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; NCRAS Tumour / Treatment data; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-29
Organisations:
Ruth Dobson - Chief Investigator - Queen Mary University of London
Sedigheh Zabihi - Corresponding Applicant - Queen Mary University of London
Claudia Cooper - Collaborator - Queen Mary University of London
Jonathan Bestwick - Collaborator - Queen Mary University of LondonOutcomes:
Cardiovascular diseases; Diabetes; Lung diseases (COPD, asthma); Epilepsy; Psychiatric diseases; Depression; Anxiety; Psychosis; Autoimmune diseases; All-cause hospitalisation; All-cause mortality; Disability (use of wheelchair, use of cane); Prescriptions; Frailty score; Cancer; Lung cancer; Breast cancer; Bowel Cancer.
Description: Lay Summary
Rationale: People with chronic illnesses affecting the nervous system (neurological diseases) like Multiple Sclerosis (MS), dementia and Parkinsonâs Disease (PD) still develop other illnesses. These co-existing diseases can affect their overall health, and people can find that their neurological illness gets worse quicker. There can also be delays in getting a diagnosis or treatment for these additional health problems, as everything is put down to the neurological problem. Understanding how these illnesses interact is crucial.
Technical Summary
Methods: We will use information from primary care services (CPRD) to: 1. Compare how common mental (e.g. depression) and physical diseases (e.g. cardiovascular diseases, cancer) are in people with and without chronic neurological diseases. 2. Compare those who have the chronic neurological condition alone, and those who also have additional illnesses to find out which co-existing diseases are associated with worse outcomes 3. Investigate how factors like ethnicity, socioeconomic status, and urban/rural living affect this?
Results and potential impact: This study aims to inform policymakers and care practices to improve the health and wellbeing of people living with a chronic neurological illness and additional health problems. We will engage with parliamentary groups, healthcare bodies, and the public to discuss our results. Results of this study will highlight the importance of screening and treating other illnesses in people with neurological disorders. This could lead to more effective and equitable care.Physical and mental comorbidities lead to poorer outcomes in chronic neurological diseases (NDs). Comorbidities are associated with more rapid progression to cognitive and disability milestones, potential loss of access to disease modifying therapies, and worse social determinants of health. We aim to explore the association between chronic NDs, comorbidities and health outcomes to help establish policy priorities. Our objectives include: 1) to investigate the relative association between common mental and physical co-morbidities and chronic NDs; 2) to explore which comorbidities affect outcomes, including disability endpoints and mortality, in chronic NDs; 3) to understand how potential health inequalities and treatment receipt interact with these relationships; 4) to establish which comorbidities should be prioritised for intervention.
We will select a cohort of people living with selected chronic NDs and match them 1:10 on birth year and gender with those who do not have a diagnosis of NDs. We will link primary care data to HES and NCRAS, and use Cox proportional hazards regression to compare the incidence of comorbidities in people with and without chronic NDs. We will additionally link to ONS death registry to compare disability and mortality in those living with chronic neurological diseases with and without the comorbidity of interest using Cox regression. We will add interaction terms from area level datasets to survival models to study these relationships in diverse ethnic, socioeconomic and rural-urban groups.
Results of this study will provide evidence for more effective, and equitable screening and targeted prevention and treatment of comorbid disease in chronic neurological diseases, with the aim of improving overall health. This project will direct considerations of wider health, economic, social care and public health measures to drive fairer access to diagnosis and treatment of comorbid illness, improving neurological outcomes across the health and social care spectrum.
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Sickness absence in the working age population in England before and during the COVID-19 pandemic: a retrospective cohort study using primary care medical certificate data — Shamil Haroon ...
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Sickness absence in the working age population in England before and during the COVID-19 pandemic: a retrospective cohort study using primary care medical certificate data
Datasets:GP data, Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-09
Organisations:
Shamil Haroon - Chief Investigator - University of Birmingham
Naijie Guan - Corresponding Applicant - University of Birmingham
James Rockey - Collaborator - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Louise Jackson - Collaborator - University of Birmingham
Mark Monahan - Collaborator - University of Birmingham
Tom Marshall - Collaborator - University of Birmingham
Tracy Roberts - Collaborator - University of BirminghamOutcomes:
Primary outcome: Medical certificates issued for sickness absence of any cause, referred to throughout the protocol as âfit notesâ. These will be defined using SNOMED-CT codes for sickness certification (also known as Statement of Fitness for Work or Med 3 Form). We will be excluding SNOMED-CT codes indicating that an individual may be able to work.
Secondary outcome: Economic loss associated with sickness absence. We will use the IMD income domain data associated with each patient to estimate the cost of their periods of sickness absence.
Description: Lay Summary
Medical certificates, also known as fit notes or sick notes, are important documents issued by healthcare professionals (e.g., doctors, nurses, etc) to explain how an individualâs health condition may limit their ability to work. Changes in how these fit notes are issued and why can help us understand health trends in society over time, spot public health issues and thus decide where to prioritise resources. There is currently a lack of research investigating the issuing of fit notes in primary care, especially in the context of significant medical, psychological, social and economic change due to public health events like the COVID-19 pandemic.
Our study aims to look at the fit notes issued to the working-age population (aged between 18 and 65) and the economic costs associated with being off work, both before and during the latter part of the COVID pandemic, using primary care medical certificate data. We will also explore if the rate of fit notes issued varies by different patient-related factors like age, sex, ethnicity, poverty, smoking, body mass index (including obesity), health condition, number of consultations, and region. Finally, we will investigate which health problems cause most of the sickness absence in the working-age population. This study will inform public health planning and policy making, ensuring we are better prepared for the transition in sickness absence in the post-pandemic era and for potential future pandemics.
Technical SummaryPeople have experienced significant medical, psychological, social, and economic changes since the COVID-19 pandemic including changes to working practices. There is little research on sickness absence in the UK working-age population using healthcare record data and the picture of how sickness absence has changed following the COVID-19 pandemic is still unclear, indicating a significant research gap. This study aims to explore all-cause sickness absence (as measured by fit notes: official medical certificates issued by health professionals in the UK to indicate an individual's inability to work due to sickness after 7 days of sickness absence) among the working-age population (aged between 18 and 65) in England before and during the latter part of the COVID-19 pandemic. This retrospective cohort study will use healthcare record data from a large primary care database, CPRD Aurum, covering the period both before the COVID-19 pandemic (from 1st January 2017 to 31st December 2019) and during the latter part of the pandemic (from 1st March 2022 to 28th February 2023). The four objectives are: 1) to quantify the rate of fit notes issued before and during the latter part of the COVID-19 pandemic, including in population subgroups; 2) to estimate the independent association between sociodemographic and health-related factors and sickness absence in both periods using multivariable Poisson regression models; 3) to explore the main causes of sickness absence in the working age population in England by using the diagnostic codes recorded at the time of or prior to the date when fit notes were issued; 4) to quantify the economic loss associated with sickness absence. Understanding sickness absence and changing trends over time will offer important insights into the general health and wellbeing of the working-age population, of high relevance to policy makers, employers, insurers, and healthcare planners and providers.
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The use of intrauterine devices versus oral contraceptives and the incidence of invasive ovarian cancer. — Samy Suissa ...
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The use of intrauterine devices versus oral contraceptives and the incidence of invasive ovarian cancer.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-09
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Anita Koushik - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Kathryn Terry - Collaborator - Brigham & Women's Hospital
Marie Helene Mayrand - Collaborator - Centre Hospitalier de l'Universite de Montreal
Robert Platt - Collaborator - McGill UniversityOutcomes:
Invasive epithelial ovarian cancer is the primary outcome, which is defined, as per the International Federation of Gynaecology and Obstetrics (FIGO) and World Health Organization classifications, as malignancies of the ovary, fallopian tube and peritoneum together.1,2 Incident ovarian cancers will be identified in the NCRAS (with the variables, patid, cr_patid, cr_id, diagnosisdatebest, coding_system, site_icd10_o2, and site_icd10_o2_3char) using International Classification of Disease (ICD)-10 codes (ICD-10 codes: C56, C57, C48.1, C48.2).
Data on histology/morphology (identified with the variables, histology_coded, histology_coded_desc, morph_coded, and morph_icd10_o2), behaviour (identified with the variables, behaviour_icd10_o2, behaviour_coded, and behaviour_coded_desc) and grade (identified with the variable, grade) of the cancer will also be obtained from the NCRAS. Ovarian cancer histotypes of high grade serous, low grade serous, endometrioid, clear cell, mucinous and other will be defined based on the combination of histology and grade (identified with the variables, stage_best, t_best, n_best, m_best, and figo).1,3Description: Lay Summary
Ovarian cancer is the deadliest of all the cancers of the female reproductive system. There are very few known modifiable risk factors associated with ovarian cancer, but the use of oral contraceptives (OCs) is one and it reduces the risk of all types of ovarian cancer. OCs have become the most commonly used form of birth control in North America and Europe, which has resulted in reductions in ovarian cancer cases since their introduction. However, in recent years, the use of OCs has declined while the use of intrauterine devices (IUDs), an alternative method of contraception, has increased. Given the role of OCs in reducing ovarian cancer risk, it is unclear whether this recent contraceptive use trend may ovarian cancer incidence. Thus, this study aims to better understand the impact of IUD use compared to OCs on future risk of ovarian cancer in women by using anonymised electronic healthcare records. This information will allow clinicians to make a more informed decisions when recommending a method of contraception to patients.
Technical SummaryThe use of OCs is one of the only modifiable risk factors known to decrease the risk of ovarian cancer, the most fatal gynaecological cancer. A recent trend that has been observed is a decreased use of OCs with a concomitant increased use of IUDs, an alternative contraceptive method. Given that the scientific literature does not currently have enough information to predict the impact of this trend on ovarian cancer, the main objective of this study is to estimate the association between IUD vs. OC use on invasive ovarian cancer incidence, overall and by histotype.
We will use the CPRD and linked databases to create an initial base cohort of female patients between the ages of 15 and 50, with a first-ever prescription for OCs and IUDs between April 01, 1998 and December 31, 2019. From the base cohort, we will use the prevalent new-user cohort design to assemble a study cohort, which will include new users of OCs, propensity score-matched to new users of IUDs without a history of OCs (i.e., OC-naïve patients), as well as IUD users who switched from using OCs, matched to continuers of OCs on their duration of previous OC use since cohort entry (i.e., OC-experienced patients), specific general practice, and propensity score. Patients will be followed using an intention-to-treat approach starting one year after entering the study cohort, and until an incident diagnosis of ovarian cancer, death from any cause, bilateral oophorectomy, end of registration with a CPRD general practice, or end of study period. We will fit Cox proportional hazards models to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for ovarian cancer.
This study will provide information on an increasingly prescribed contraceptive method (i.e., IUD) and its possible impact on the future risk of ovarian cancer, compared to having used OCs.
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The efficacy and safety of concomitant treatment with rosuvastatin and perindopril : Outcomes in real world practice — Christopher Morgan ...
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The efficacy and safety of concomitant treatment with rosuvastatin and perindopril : Outcomes in real world practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-07-18
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Dominik Nabergoj - Collaborator - Krka - Slovenia
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Irena Orel - Collaborator - Krka - Slovenia
Sara Redenšek Trampuž - Collaborator - Krka - SloveniaOutcomes:
Mean change in systolic blood pressure (SBP), mean change in non-high density lipoprotein (non-HDL) cholesterol, proportion of patients with SBP <140 mmHg, proportion of patients with a reduction in SBP from baseline of â¥20 mmHg, proportion of patients with a non-HDL cholesterol reduction of >40%, rolling average of SBP, correlation of baseline and checkpoint SBP, rolling average of non-HDL cholesterol, correlation of baseline and checkpoint non-HDL cholesterol, mean change in Framingham risk score, mean change in diastolic blood pressure (DBP), mean change in total cholesterol, mean change in low density lipoprotein (LDL cholesterol), mean change in triglycerides, safety events (presented individually, by type/site and overall): abdominal pain, acute renal failure, agranulocytosis or pancytopenia, angina pectoris, angioedema, anuria/oliguria, arrythmia, arthralgia, asthenia, blood bilirubin increased, blood creatinine increased, blood urea increased, bronchospasm, chest pain, confusion, constipation, cough, depression, diabetes mellitus, diarrhoea, dizziness, dry mouth, dysgeusia, dyspepsia, dyspnoea, eosinophilia, eosinophilic pneumonia, erectile dysfunction, erythema multiforme, fall, flushing, gynaecomastia, haematuria, haemoglobin decreased and haematocrit decreased, haemolytic anaemia in patients with a congenital deficiency of g-6pdh, headache, hepatic enzyme increased, hepatitis, hyperhydrosis, hyperkalaemia, reversible on discontinuation, hypersensitivity reactions, hypoglycaemia, hyponatraemia, hypotension (and effects related to hypotension), immune-mediated necrotising myopathy, increased hepatic transaminases, jaundice, leucopenia/neutropenia, lupus-like syndrome, malaise, memory loss, mood disturbances, muscle cramps, muscle rupture, myalgia, myasthenia gravis, myocardial infarction, myopathy (including myositis), nausea, ocular myasthenia, oedema, palpitations, pancreatitis, paraesthesia, pemphigoid, peripheral neuropathy, photosensitivity reactions, polyneuropathy, pruritus, psoriasis aggravation, pyrexia, rash, Raynaud's phenomenon, renal insufficiency, rhabdomyolysis, rhinitis, sleep disorder, sleep disturbances (including insomnia and nightmares), somnolence, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (dress), stroke possibly secondary to excessive hypotension in high-risk patients, syncope, syndrome of inappropriate antidiuretic hormone secretion, tachycardia, tendon disorders, thrombocytopenia, tinnitus, urticaria, vasculitis, vertigo, visual disturbances, vomiting.
Description: Lay Summary
Cardiovascular disease (CVD) refers to a range of conditions caused by disorders of the blood vessels including heart disease and stroke. Risk of CVD is influenced by a multiplicity of risk factors. Some like age, are fixed but others such as blood pressure and cholesterol can be modified by lifestyle changes or by medication. Patients at higher risk of CVD events may therefore be offered treatment. In this study we want to use the Clinical Practice Research Datalink to see what happens to these two key CVD risk factors (cholesterol and blood pressure) when patients taking either a cholesterol lowering drug (rosuvastatin) have a blood pressure lowering drug (perindopril) added, or those initially on perindopril have rosuvastatin added, or those who have perindopril and rosuvastatin prescribed together for the first time. We will compare cholesterol and blood pressure and other risk factors before perindopril and rosuvastatin are taken together to two subsequent timepoints (30â150 days and 90â270 days). We will also see if these patients have side-effects in the 12 months after taking the two drugs together and compare them to other patients on the same initial drug who have a different drug added. By conducting such a study, we aim to show that the use of the drugs in combination is effective and safe which may improve patient outcomes and provide savings for healthcare services.
Technical SummaryCardiovascular disease (CVD) affects approximately 50 million people in Europe and is associated with approximately 60 million life years lost. Guidelines recommend that for people aged over 40, cardiovascular risk score should be regularly assessed and, if necessary, medication for modifiable risk factors prescribed. We propose a retrospective, primarily single-arm study in the Clinical Practice Research Datalink GOLD and Aurum databases to evaluate the efficacy of combination rosuvastatin/perindopril therapy. In addition, a comparative arm whose initial therapy (rosuvastatin or perindopril) is augmented with a different respective lipid-lowering/anti-hypertensive agent will assess drug safety. Patients with a diagnosis of hypertension prescribed rosuvastatin or perindopril who have the other drug added and naïve patients will form the study cohort. Index date will be the date that rosuvastatin and perindopril were prescribed concomitantly. Alternate anti-hypertensives or lipid-lowering therapies may be present but must have been prescribed at least one month prior to the relevant baseline values and at a stable dose. Baseline primary risk factor markers (systolic blood pressure (SBP) and non-high-density lipoprotein (non-HDL) cholesterol recorded within 6 months) will be compared to two subsequent timepoints post index date (30â150 days and 90â270 days) using the dependent t-test or paired sample Wilcoxon signed-ranks test. Additional outcomes will be the proportion of patients reaching targets defined as SBP <140 mmHg, SBP reduction of â¥20 mmHg, and non-HDL reduction >40%. Mean change in Framingham risk score, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol and triglycerides will also be compared at both checkpoints. The incidence of safety events will be reported in the year post-index and compared to the comparative arm by incidence rate ratios evaluated by the mid-p test. This study will provide valuable data to inform the impact of these drugs in combination on outcomes with ultimate efficiencies for health services.
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ID-417: Transforming Women’s Health: mapping out pathways and trajectories — Imperial College Health Partners...
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ID-417: Transforming Women’s Health: mapping out pathways and trajectories
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-24
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Women’s health. Commercial
Source
2024 - 06
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Changes in Cohort Characteristics and Outcomes During the COVID-19 Pandemic for Three Active Comparator, New User Cohorts — Samy Suissa ...
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Changes in Cohort Characteristics and Outcomes During the COVID-19 Pandemic for Three Active Comparator, New User Cohorts
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-14
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Gwen Aubrac - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Michael Webster-Clark - Collaborator - McGill University
Qi Zhang - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Incidence rates for the first occurrence of three different types of outcomes, with some outcomes specific to specific active comparator/new user cohorts:
1) Event-based outcomes (stroke, all-cause mortality, myocardial infarction, hospitalization for heart failure, lower extremity amputation, hospitalization for hypoglycemia, chronic obstructive pulmonary disease [COPD] exacerbation, hospitalization for suicidal ideation)
2) New onset of comorbidities related to COVID-19 (type 2 diabetes, hypertension, depression, hyperlipidemia, COPD, heart failure, end stage renal disease)
3) Procedures and diagnoses requiring in-person procedures or office visits (diabetic retinopathy, breast cancer screening, colon cancer screening)
Description: Lay Summary
COVID-19 changed everyday life and how people access healthcare, like going to the doctor, getting vaccinated, or receiving check-ups. However, life changed for different people in different ways. Different countries faced different types of the virus and had different rules about staying home and wearing masks. Many researchers use information on healthcare from around the world to find out what makes people healthy or sick. So, when things like COVID-19 happen, they need to know how people and countries are different in terms of their health. This is why we are making visual tools to see how healthcare is different in different countries and people. As an example, we are looking at what happens after people start a new medication depending on where they are in the world and if they started before or after COVID-19 started spreading. We chose to look at medications for problems with blood sugar, blood pressure, and depression. We also chose to look at three things: events like a heart attack, being told you have new health problems, and diseases requiring doctors to check in person if you have them. Our visual tools will be used to compare people in Ontario, British Columbia, and the United Kingdom through graphs.
This project will help people by creating tools scientists can use to see how different groups are affected by different diseases. This will make it easier to put together results from different countries to understand how drugs help or cause diseases.
Technical SummaryThe COVID-19 pandemic had major impacts on healthcare systems worldwide that varied greatly in their timing and magnitude. Different countries (and different jurisdictions within countries) also pursued responses to the pandemic that varied greatly. The resulting heterogeneity has major implications for public health research that aims to combine and synthesize treatment effect estimates from different jurisdictions. We previously developed visualizations showing and evaluating heterogeneity in treatment distributions, outcome rates, covariates distributions, covariate imbalances, and subgroup treatment effect estimates across a multi-site study by separating a cohort of CPRD patients with diabetes initiating treatment with metformin or sulfonylurea prior to the pandemic into distinct regions. In this project, we plan to apply these tools to visualize heterogeneity in multi-site active comparator new user studies of commonly studied medication classes from 2019 through the most available CPRD data. Our primary exposure will be exposure to ¬¬SSRIs and SNRIS for the treatment of depression and our primary outcome will be all-cause mortality. Similar analyses will be performed for other outcomes related to COVID-19 to further display the potential for these visualization tools. We will use inverse probability weights based on propensity scores estimated using multivariable logistic regression to estimate treatment effects on the outcome. After conducting the initial analyses and understanding the trends specific to the patients within CPRD, the calendar time trends in treatment, outcome rates, covariates, and treatment effect estimates from the UK will be compared with results from separately analysed British Columbia and Ontario cohorts to understand the utility of these visualizations in a real-world case study and illustrate the potential for rapid applications of these visualizations to capture the impacts of heterogeneous responses to future shocks to healthcare system.
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Population-based cohort study on patient characteristics, treatments and survival in diseases of regulatory interest — Daniel Prieto...
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Population-based cohort study on patient characteristics, treatments and survival in diseases of regulatory interest
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-25
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Marta Pineda Moncusi - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Kim López-Güell - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
Summary characteristics (demographics, comorbidities, comedication) of people diagnosed with the disease of regulatory interest, treatment options and sequences over time, mortality rates (all-cause or disease-specific).
Description: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe.
One area of research relates to describing characteristics, such as age and sex, treatment options and mortality of people diagnosed with a condition of interest. The description of the characteristics, treatment options and mortality are important from a regulatory point of view to provide context and help understand how new medicines may add value for patients.
The EMA will request several studies of the same design to assess how common specific conditions are in the population and how many people die from these conditions. This will help the regulators to inform preventative measures that could be introduced to reduce disease spread or disease burden, and subsequently reduce risk for mortality for affected people wherever possible. The first example will focus on a relatively rare bone cancer, "chondrosarcoma", which every year affects between 1 to 5 people for every one million.
Technical SummaryPrimary care records provide a unique source of data for describing the characteristics of individuals diagnosed with specific diseases at a population-level, their specific drug treatments used in the community, and mortality rates in people affected by these diseases. The âData Analysis and Real World Interrogation Network (DARWIN EU)â initiative created by the European Medicines Agency (EMA) intends to draw upon such data for regulatory decision making: such studies could help to assess disease burden in the population, understand the impact of measures to reduce mortality in affected patients and, for rare diseases, provide the possibility of faster approval of new, innovative treatments through a different regulatory pathway for orphan medicines. EMA will therefore request several studies assessing the natural history of diseases.
> Study design: Cohort study
> Population: people diagnosed with the disease of regulatory interest in CPRD GOLD or CPRD AURUM. Additional exclusion criteria may apply according to the study objective (including history of specific conditions and minimum follow-up time).
> Diseases of regulatory interest:
- Chondrosarcoma
Additional diseases of regulatory interest will be declared in future protocol amendments upon request by EMA.> Covariates:
- Age
- Sex
- Calendar period/Time windows (to monitor changes over time)
- Other subgroups (such as specific disease sub-types and/or treatment regimen types)
- Patient specific characteristics in terms of comorbidity and use of concomitant medication at the time of interest.> Analyses:
1) Summary of characteristics (demographics, comorbidities, comedication) of people diagnosed with the disease of regulatory interest.
2) Description of treatment options and sequences over time among people with new diagnoses of diseases of interest.
3) Estimation of mortality rates in people affected by the disease of regulatory interest, focussing on all-cause mortality or cause-specific mortality related to the respective disease of regulatory interest.
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Identifying early indicators of prostate cancer progression from longitudinal clinical data. — Vasilis Stavrinides ...
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Identifying early indicators of prostate cancer progression from longitudinal clinical data.
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-03
Organisations:
Vasilis Stavrinides - Chief Investigator - University College London ( UCL )
Vasilis Stavrinides - Corresponding Applicant - University College London ( UCL )
James Bailey - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Nora Pashayan - Collaborator - University of Cambridge
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
prostate cancer-specific death; death by any cause; prostate cancer metastasis; clinically significant prostate cancer on pathology (either biopsy or surgical specimen); clinical progression as per universally accepted definitions (ICECaP; Sweeney et al. 2015)
Description: Lay Summary
Every year, thousands of men in the UK are going to the doctor to get checked for prostate cancer. New tests and better scans are helping us find prostate cancer earlier, which means we can treat people quickly and help them feel better sooner.
When doctors find cancer in a man's prostate, they can't be sure if it will grow slowly or spread fast. This is a very important problem because men with slow-growing cancers might not need treatment right away, whereas men with fast-growing cancers have to get treated immediately.
To solve this problem, we will study lots of information from thousands of men who've been checked for prostate cancer over many years across the entire country. If we learn more about how prostate cancers grow, we could help doctors decide who needs treatment immediately and who can wait. That way, everyone gets the right treatment at the right time.
Technical SummaryThe overarching aim of this project will be to describe the longitudinal dynamics of PSA, clinical, pathological and imaging data before diagnosis or treatment of clinically significant prostate cancer, with particular emphasis on longitudinal clinical-PSA trajectories and histological transitions on serial prostate pathology.
The main population of interest will be men with longitudinal PSA or other clinical measurements, particularly those initially biopsy-negative or diagnosed with insignificant disease. The primary outcomes will be diagnosis of clinically significant cancer (warranting radical or systemic treatment), metastasis and death (prostate cancer-specific, or by any cause). Therefore, this will be a retrospective cohort study and a range of regression, time-to-event and longitudinal modelling techniques will be used to determine whether "rapid" progression to significant cancer is associated with specific longitudinal patterns preceding the events of interest.
The data sources will be Hospital Episode Statistics (to determine inpatient admissions for prostate interventions, including biopsies), the Diagnostic Imaging Dataset (to identify prostate imaging), cancer registration, systemic anti-cancer (SACT) and radiotherapy information (to note any cancer diagnoses or treatments), ONS mortality data, as well as community-based information (such as PSA values measured at GP practices, coupled with records of prostate-related visits).
The public health benefits of this research will be numerous. For example, estimating the transition rates between prostate cancer categories on pathology (e.g. initial and pre-treatment biopsies) and getting an understanding PSA trends along the disease course are vital for optimising screening strategies, improving the risk stratification of newly diagnosed cancers, and refine the active surveillance of low-risk tumours. Furthermore, population-level estimates of cancer rates in men with initially negative prostate biopsy are also urgently needed to manage the over 17,000 such cases every year in England and Wales. Finally, we will investigate health and socioeconomic factors affecting access to prostate cancer services.
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Trends and Patterns in Multimorbidity in Children and Young People — Lorna Fraser ...
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Trends and Patterns in Multimorbidity in Children and Young People
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-04
Organisations:
Lorna Fraser - Chief Investigator - King's College London (KCL)
Lorna Fraser - Corresponding Applicant - King's College London (KCL)
Ingrid Wolfe - Collaborator - King's College London (KCL)Outcomes:
incidence rate of multimorbidity in children and young people (0-18 years)
clusters of multimorbidity in children and young people (0-18 years)Description: Lay Summary
Many more people are living with two or more long term health conditions which impact on their quality of life and demand from health and care services. We know that many long-term health conditions begin in early life, however at present we do not have good information on the number of children and young people living with two or more health conditions. This information is important in terms of planning both preventative measures and planning service so that the needs of children and young people can be met effectively and efficiently i.e combining mental and physical health appointments.
Technical Summary
This study aims to use data collected by general practices and including information on diagnoses from hospital data to describe how common multi morbidity is in children and young people, how this has changed over time and how these diagnoses tend to cluster together.
This information will then be used to help inform targeting future prevention activities and any change to delivery of health services.Aim: to characterise and quantify clusters of multimorbidity in children and young people and assess the trends over time
Population: birth cohorts of all children born in four years - 2000, 2005, 2010 AND 2015
Study design: comparative cohort study.
Data sources: Linked data across primary (CPRD Aurum) and secondary care (HES APC) data.
Primary exposure: Year of birth
Primary outcomes: incidence rate of multimorbidity
Statistical tests: Descriptive statistics will be used to describe the incidence rate of multimorbidity and sociodemographic characteristics and trends over time.
Multivariable poisson/negative binomial regression models will be used to estimate the association between year of birth and the incidence rate of multimorbidity and variation (by ethnicity, socioeconomic position, geography) and to identify groups where associations are strongest.
Latent class analysis will be undertaken to develop cluster of diagnoses of multimorbidity in children.
Implications:
Understanding the nature and quantity of multimorbidity in children will enable the further targeting of interventions to prevent multimorbidity and interventions to manage multimorbidity i.e. combined services, scheduling of appointments
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Burden of Disease of Herpes Zoster among adults aged 18 years old and older at increased risk due to an immunocompromising or chronic condition in England: a retrospective cohort study — Caroline O'Leary ...
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Burden of Disease of Herpes Zoster among adults aged 18 years old and older at increased risk due to an immunocompromising or chronic condition in England: a retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Caroline O'Leary - Chief Investigator - IQVIA Ltd ( UK )
Karabo Keapoletswe - Corresponding Applicant - IQVIA Ltd ( UK )
Bhagya Chengat - Collaborator - IQVIA Ltd ( UK )
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
Sarah Lay-Flurrie - Collaborator - IQVIA Ltd ( UK )
Saskia Hagenaars - Collaborator - IQVIA Ltd ( UK )Outcomes:
Primary outcomes
Annual and overall incidence rate of herpes zoster (HZ; defined using MedCodes in CPRD Aurum and ICD-10 codes in HES) from 2012 to 2019 in the IC subpopulation (defined using CPRD-HES linkage).Secondary outcomes
Annual and overall incidence rate of HZ from 2012 to 2019 in the chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup; prevalence of HZ occurrence, IC conditions and chronic conditions from 2012 to 2019 in the overall population; overall rate of HZ complications (postherpetic neuralgia [PHN, developed within 90 to 365 days of initial HZ event], neurological complications, ocular complications, disseminated complications and other HZ-related complications) in the IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup; cause-specific mortality rate due to HZ and/or HZ complications (as aforementioned) in the IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup; overall rate of all-cause healthcare resource utilisation (HCRU) for inpatient admissions, outpatient visits, accident and emergency visits, general practitioner visits and HZ prescriptions and associated costs of each for HZ patients, PHN patients and PHN-free patients in the IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup; incidence rate ratio of HZ for the IC subpopulation vs the non-IC and non-chronic subgroup, and the chronic subpopulation vs the non-IC and non-chronic subgroup; sociodemographic characteristics (age, age group, sex, practice region, ethnicity, smoking status, alcohol consumption, socioeconomic status [using IMD score] at patient and practice level, follow-up time from relevant population index date, and follow-up from HZ index date) for the overall population, IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup.Exploratory outcomes
Proportion of patients who had undergone immune-suppressing treatments in select IC subpopulations (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, psoriasis/psoriatic arthritis, multiple sclerosis, polymyalgia rheumatica, and autoimmune thyroiditis) and chronic subpopulations (diabetes mellitus, chronic obstructive pulmonary disease, chronic kidney disease, asthma); risk factors (age group, sex, body mass index, smoking status and alcohol consumption) for HZ related complications (as aforementioned) in the IC subpopulation and IC-free subpopulation; annual rate of HZ recurrence in the IC subpopulation and IC-free subpopulation; annual and overall incidence rate of HZ (defined using MedCodes in CPRD Aurum only) from 2012 to 2023 in IC subpopulation (defined using CPRD Aurum only); annual and overall incidence rate of HZ (defined using HZ algorithms) from 2012 to 2019 in the IC subpopulation (defined using CPRD-HES linkage); overall rate of PHN (developed within 365 days of initial HZ event) in the IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup; cause-specific mortality rate due to PHN (developed within 365 days of initial HZ event) in the IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup; overall rate of all-cause HCRU of inpatient admissions, outpatient visits, accident and emergency visits, general practitioner visits and HZ prescriptions, and associated costs of each, for PHN patients (developed within 365 days of initial HZ event) in the IC subpopulation, chronic subpopulation, IC-free subpopulation and non-IC and non-chronic subgroup.Description: Lay Summary
The aim of this study is to observe how many patients develop Herpes Zoster (HZ), also known as shingles, and related complications in adulthood. It also aims to understand how often patients with HZ use the health service and if HZ and its complications result in death.
HZ is a viral infection which happens due to reactivation of the same virus that causes chicken pox. Previous research has shown that older patients and/or patients with conditions that weaken the immune system are more likely to develop HZ in their lifetime.
For this study, we will use general practitioner and hospital records data starting from January 2012. We will include adults who have not had HZ or received the HZ vaccine at the beginning of the study. We will observe patients who are diagnosed with HZ from 2012 and describe what happens to these patients after they are diagnosed. We will describe this for everyone included in the study and in groups of patients with conditions that weaken the immune system and/or other chronic conditions, or none of these conditions.
In the United Kingdom, there is a vaccine currently recommended for patients over 60 years old and for those who are over 50 with weakened immune systems. The results from this study will help assess if the vaccine should be recommended for more patient groups.
Technical SummaryThis retrospective cohort study will be conducted on adults aged 18 years and above in CPRD Aurum-Hospital Episodes Statistics linked data (01 January 2012 to 31 December 2019) and CPRD Aurum data (01 January 2012 and 30 June 2023). This study will include adults with no history of a herpes zoster (HZ) diagnosis, who have not received an HZ vaccine (zoster vaccine live [ZVL] or recombinant zoster vaccine [RZV]) and have a one-year minimum follow-up before study entry. This overall population will be categorised into an immunocompromising (IC) subpopulation, a chronic subpopulation, an IC-free subpopulation, and a subgroup of patients who are both IC- and chronic-free.
The primary aim of this study is to evaluate the burden of HZ in England, with a focus on estimating the HZ incidence rate within the IC subpopulation. Other key analyses will include assessing HZ incidence and recurrence rates in other subpopulations, describing the socio-demographic characteristics of HZ and non-HZ patients, evaluating the rate of healthcare resource use and associated cost in primary and secondary healthcare settings for HZ patients, risk factors of HZ complications and the mortality rate due to HZ and/or its complications. Continuous and categorical variables will be analysed descriptively i.e., reporting mean, standard deviation, median, interquartile range, minimum and maximum, number and percentage of patients. Annualised and overall rates will be presented as the number of events per 1000 patient-years with 95% confidence intervals. Logistic regression models will be used for the risk factor analysis. Select analyses will be stratified by age group, sex, socioeconomic status (using Index of Multiple Deprivation), practice region and/or condition. The study will provide up-to-date data on the burden of HZ which will help inform plans to expand RZV vaccination to other populations currently not included in the Joint Committee on Vaccination and Immunisation recommendation.
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The association between denosumab use and the risk of atypical femoral fractures in osteoporosis management. — Samy Suissa ...
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The association between denosumab use and the risk of atypical femoral fractures in osteoporosis management.
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-12
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
David Goltzman - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Lisa Lix - Collaborator - University of Manitoba
Roland Grad - Collaborator - McGill University
Stephane Bergeron - Collaborator - McGill University
Suzanne Morin - Collaborator - McGill University
Ying Cui - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Our primary outcome will be incident AFF.
Description: Lay Summary
Osteoporosis is a common chronic disorder whereby bones become weakened during aging and are easily broken (i.e. fractured), leading to increased morbidity and mortality. A commonly used medication in osteoporosis management is denosumab which has been shown to significantly reduce the risk of vertebral, non-vertebral and hip fractures. Although denosumab is an effective treatment for osteoporosis, there have been recent reports of denosumab causing atypical femoral fractures (AFF) which are fractures that differ from typical fractures whereby they have delayed healing and have a higher risk of non-union (i.e. failure to heal properly). To further address this concern, our study's objective will be to determine whether individuals with osteoporosis, treated with denosumab have a higher risk of AFF using a population-based cohort study.
Technical Summary
The findings from our study will inform patients and the clinical community on whether denosumab increases the risk of AFF, which can lead to development of strategies to improve the treatment of osteoporosis with an aim of AFF risk reduction.Overview: Denosumab is one of the antiresorptive agents frequently used to treat osteoporosis. Recently, case reports have emerged describing individuals who developed atypical femoral fracture (AFF) while being treated with denosumab. Given that denosumab is an anti-resorptive agent that can lead to AFF, there is need to study whether denosumab treatment for osteoporosis is associated with an increased risk of AFF.
Objective: To determine the risk of AFF among individuals treated with denosumab for osteoporosis using a population-based cohort study.
Methods: We will use data from the Clinical Practice Research Datalink (CPRD) Aurum, a large primary care database from the United Kingdom to conduct a population-based cohort study. We will also link CPRD with the Hospital Episode Statistics (HES) data and the HES Diagnostic Imaging Datasets (HES DID) to identify AFF, for our study. We will assemble a cohort of individuals with osteoporosis newly initiated on osteoporosis medications between 2010 and 2022, followed until June 2023. Time-dependent Cox proportional hazards models will be used to estimate the hazard ratio and corresponding 95% confidence interval of incident AFF among denosumab users versus individuals with osteoporosis receiving other non-bisphosphonate therapies for osteoporosis, adjusting for multiple covariates. We will also conduct several sensitivity analyses to confirm our findings.
Expected outcomes: Use of denosumab has increased over the years due to its efficacy in treating osteoporosis and reducing the risk of fractures. In light of reports of AFF among individuals treated with denosumab for osteoporosis, this study will determine whether denosumab use increases the risk of AFF in the real-world setting. The findings from this study will further inform patients and their physicians whether AFF is associated with denosumab use, which may lead to the development of strategies to mitigate this risk and allow patients with osteoporosis to continue to benefit from denosumab treatment.
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Understanding the mental health and cardiometabolic diseases outcomes experienced by survivors of knife-related assaults — Joht Singh Chandan ...
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Understanding the mental health and cardiometabolic diseases outcomes experienced by survivors of knife-related assaults
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-10
Organisations:
Joht Singh Chandan - Chief Investigator - University of Birmingham
Joht Singh Chandan - Corresponding Applicant - University of Birmingham
Illin Gani - Collaborator - University of BirminghamOutcomes:
Objective 1: Epidemiology of knife crime victim
⢠Annual incidence rate per million person years will be calculated
⢠Annual prevalence per million population will be calculatedTo avoid any risk of reidentification we will not undertake sub-group analyses by demography or otherwise. Additionally, we will only present aggregate level details about the cohorts across the full time period.
Objective 2: Outcomes of knife crime victims
We aim to explore the risk of all health outcomes including physical, mental and social, in accordance to the WHO definitions and the Global Burden of Health (1,2). We aim to explore the risk of mental health outcomes and cardiometabolic diseases, in accordance to the WHO definitions and the Global Burden of Health (1,2). Our study will prioritise mental health outcomes as primary outcomes and cardiometabolic disease as secondary outcomes. Mental health outcomes include the following conditions below:
· Depression disorders
· Anxiety disorders
· Mood disorders
· Psychotic disorders
· Eating disorders
· Post-Traumatic Stress Disorders (PTSD)
· Obsessive-Compulsive Disorders (OCD)
· Attention-Deficit/Hyperactivity Disorders (ADHD)
· Personality disorders
· Substance use disorders
· Suicide
· fibromyalgia
Chronic fatigue syndromeCardiometabolic disease includes the following conditions below:
· Coronary heart disease
· Stroke
· Hypertension (high blood pressure)
· Diabetes mellitus (type 2)
· Obesity
· Dyslipidaemia
· Metabolic syndrome
· Heart failure
· Peripheral artery disease (PAD)
· Atrial fibrillation
Description: Lay Summary
Knife crime, defined by British law, is a crime involving a knife or a sharp instrument to harm, threaten or hurt others. In the United Kingdom (UK), knife-enabled crimes encompass various forms including aggravated assault, threats, robbery, and homicide. Knife crime victims are individuals who are subjected to such violent exposure and are often associated with young males in deprived areas. Since 2014, the UK has seen a clear and consistent rise in violent crimes and offences caused by sharp instruments. Therefore, knife crime is a public health issue.
Exposure to knife crime is associated with health problems and mortality, manifesting through mental, physical, and social health outcomes. Current literature exposes the mental health determinants of knife crime victims such as anxiety, depression, Post-Traumatic Stress Disorder (PTSD) and other mental health disorders. Physical health outcomes include mobility loss, organ damage, infections and pain. Previous studies that used âTrauma Audit Research Networkâ captured the overall and reported the correlation between knife crime exposure and physical outcomes.
However, the lack of research on health outcomes including physical, mental and social of knife crime victims portrays a critical gap in understanding the nature and ramifications of knife crime in the UK population. Therefore, we aim to explore Hospital Episode Statistics (HES) and GP-linked datasets on a wider scale and provide a truer depiction of the health burden of knife crime in the UK. Understanding this better will be able to inform policymakers on more effective prevention strategies, resource allocation and public awareness.
Technical SummaryAims: 1) Explore the prevalence and incidence of knife crime and 2) to describe the burden of health in patients who are deemed to be a victim of knife crime
Population and data sources: All patients who contribute to CPRD GOLD, AURUM and linked HES admitted patient data between 1st January 2001 to 1st January 2022
Exposure: Victim of knife-enabled crime including use of any other sharp object.
Outcomes (relevant to aim 2): The risk of developing a variety of health outcome including physical, social and mental.
Study Design: 1) Annual incidence rates will be calculated by dividing the number of eligible patients, who for the first time meet the knife crime victim exposure criteria (numerator) by the total number of person-years at risk (denominator) for the given year. 2) Annual point prevalence will be the proportion of knife crime victims on 1 January each year of the study. 3) We propose to undertake a series of population-based retrospective open cohort studies to explore the risk of such negative consequences following exposure to knife-enabled crime. We will calculate the incidence rate of each outcome of interest and where suitable use a Cox proportional Hazard model to describe risk.
Intended benefits: 1) Improve estimation of the health burden of knife crime victims to support commissioners and policy makers and 2) to highlight the estimated associated health burden and identify particular condition which could aid targeted preventative approaches to support knife crime victims.
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Prevalence and factors associated with low-allergy formula milk prescription in England — Robert Boyle ...
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Prevalence and factors associated with low-allergy formula milk prescription in England
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-13
Organisations:
Robert Boyle - Chief Investigator - Imperial College London
Nikita Punjabi - Corresponding Applicant - Imperial College London
Dougal Hargreaves - Collaborator - Imperial College London
Kimberley Foley - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
Sonia Saxena - Collaborator - Imperial College LondonOutcomes:
Primary:
Proportion and characteristics of children in England prescribed low-allergy formula milk by age 2 years ; Prescribing frequency and duration of low-allergy formula milk prescribed to children under 2 years in England
Secondary:
Difference in healthcare utilisation associated with prescription of low-allergy formula milk ; Factors (service - GP practice, clinical - child/maternal and sociodemographic) associated with prescription of low-allergy formula milkDescription: Lay Summary
Cowâs milk allergy (CMA) is an allergy that occurs after consuming cowâs milk or dairy products. This includes cheese, yoghurt and butter. It is one of the most common food allergies, affecting about 1 in 100 children under 2 years old. The symptoms vary from skin redness and itchiness to vomiting and diarrhoea. It can also cause wheezing and shortness of breath or general discomfort. Doctors prescribe low-allergy formula milk for children with suspected CMA who need formula milk. In England, doctors prescribe much more low-allergy formula milk compared with 10 years ago. Low-allergy formula milk prescriptions have also increased in other countries. Low-allergy formula milks have more "free sugars" than standard formula milk and breastmilk. Too much 'free sugars' can cause dental decay and childhood obesity.
We will use routinely collected data from primary care to see how many children in England got low-allergy formula milk by age 2. We will also see if certain factors make a child more likely to get low-allergy formula milk. We will compare children who got low-allergy formula milk to those who did not. These findings will help us understand which children are more likely to get low-allergy formula milk. This will enable us to develop strategies to improve prescribing of low-allergy formula milk. This has potential to reduce negative health effects by limiting future increases in low-allergy formula milk prescribing.
Technical SummaryBackground:
Cowâs milk allergy (CMA) affects about 1% of children under 2 years.1 Prescription rates of low-allergy formula milk are up to 15 times higher than expected, suggesting CMA overdiagnosis.2,3 The consequences of exposure of large numbers of infants to low-allergy formula milk designed to manage CMA are not fully understood.3-6 Low-allergy formula milks have higher amounts of âfree sugarsâ which potentially carries risks to child health and development, in particular dental decay and childhood obesity.3,6-9Aim: Describe the prevalence and factors associated with prescription of low-allergy formula milk in England.
Study population: All children born in England registered with general practice from January 2008-December 2021.
Outcomes:
â¢Proportion and characteristics of children in England prescribed low-allergy formula milk by age 2 years
â¢Prescribing frequency and duration of low-allergy formula milk in children under 2 years in England
â¢Healthcare utilisation associated with prescription of low-allergy formula milk (such as dental extractions)
â¢Factors (service - GP practice, clinical - child/maternal and sociodemographic) associated with prescription of low-allergy formula milkData sources:
CPRD Aurum â identify community prescribing, health and demographic information for children.
HES APC â explore healthcare utilisation (dental extractions) associated with prescription of low-allergy formula milk.
IMD data â analyse if associations vary by deprivation.
Mother-baby link and pregnancy register â explore potential maternal factors associated with prescription of low-allergy formula milk.Study design:
Retrospective cohort study.Analysis: Descriptive statistics and regression to explore associations between factors and low-allergy formula milk prescriptions.
Intended public health benefit:
This research will increase our understanding of the current number of children prescribed low-allergy formula milk and the factors that are associated with prescription rates in England. This helps clinicians to recognise children at higher risk of potentially unnecessary low-allergy formula milk prescriptions and raise awareness of the potential harms of CMA overdiagnosis.
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Post-authorisation Safety Study (PASS) of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries — Joan Forns Guzman ...
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Post-authorisation Safety Study (PASS) of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Joan Forns Guzman - Chief Investigator - RTI Health Solutions ( USA )
Christine Bui - Corresponding Applicant - RTI Health Solutions ( USA )
Elena Rivero-Ferrer - Collaborator - RTI Health Solutions ( USA )
Jaume Aguado - Collaborator - RTI Health Solutions ( USA )
Joan Fortuny - Collaborator - RTI Health Solutions ( USA )
Kim Wideman - Collaborator - RTI Health Solutions ( USA )
Monica Bertoia - Collaborator - Pfizer Inc - US Headquarters
Raquel Garcia Esteban - Collaborator - RTI Health Solutions ( USA )Outcomes:
The primary outcome will be MACE and will comprise the first occurrence of any of its individual components during follow-up: hospitalisation for acute myocardial infarction (AMI), fatal or non-fatal; hospitalisation for stroke, fatal or non-fatal; out-of-hospital coronary heart disease death; out-of-hospital cerebrovascular death; coronary bypass surgery; coronary revascularization.
The secondary outcomes will be the individual components of MACE listed above. The study will define other variables that will be used to describe the study population and to control for confounding, including demographic variables and lifestyle factors, comorbidities (including migraine), prior treatments for migraine, other comedications, and health care utilisation.
Description: Lay Summary
Migraine is a common and debilitating neurological disorder, and patients with migraine can be at higher risk for heart problems. The aim of this study is to help doctors know which patients with migraine and prior history of cardiovascular disease might benefit from treatment with rimegepant. Rimegepant is a medication that was recently approved in the United Kingdom (UK) and Europe to treat acute migraine and to prevent episodic migraine. The objective of this research is to evaluate, in real-world practice in the UK (and in three European countries) if there is an association between rimegepant use and major adverse cardiovascular events in patients with migraine and prior cardiovascular disease. This study will also research the patient characteristics of people who use rimegepant for acute migraine or to prevent migraine who have a history of cardiovascular problems and describe their patterns of use of the medication.
Technical SummaryThis is a non-interventional population-based prospective cohort study using a prevalent new-user design. The research question is: does the use of rimegepant increase the risk of major adverse cardiovascular events (MACE) compared with other treatments for migraine in patients with migraine and history of cardiovascular disease (CVD)? The study population will comprise adults with migraine and history of CVD registered in CPRD and three other European data sources who are on treatment with a qualifying acute or preventive migraine medication during the study period. CPRD data will include general practitioner, Hospital Episode Statistics (HES) and ONS Death Registration Data to determine if an event has occurred. The outcomes are MACE, including hospitalisation for fatal or non-fatal AMI, hospitalisation for fatal or non-fatal stroke, out-of-hospital coronary heart disease death, out-of-hospital cerebrovascular death, coronary bypass surgery or coronary revascularization. Confounding will be addressed primarily by propensity score weighting to balance cohorts with respect to factors present at or before the time of cohort entry. Crude and adjusted cumulative incidence rates with corresponding 95% confidence intervals will be calculated for each outcome using a Poisson regression model, and cumulative incidence of MACE will be estimated using the Kaplan-Meier estimator. Unadjusted hazard ratios will be estimated using a Cox regression model. To adjust for potential baseline confounding, stabilised weights for the inverse probability of treatment initiation at baseline will be used. This study is in response to a request from EMA and MHRA to conduct a PASS to evaluate whether there is an increased risk of MACE among patients with migraine and history of CVD initiating treatment with rimegepant compared with patients with migraine and history of CVD who are on other treatments for migraine. The study will also describe the use of rimegepant in the initial years after approval in the same population.
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A longitudinal analysis investigating the prevalence of overweight and obesity in adolescents — Jennifer Davidson ...
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A longitudinal analysis investigating the prevalence of overweight and obesity in adolescents
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-19
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Andre Ng - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Ghazanfar Ali - Collaborator - Novo Nordisk Ltd
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Margherita Bortolini - Collaborator - Novo Nordisk Ltd
Marion Escafit - Collaborator - Novo Nordisk Ltd
Rebecca Joseph - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
Prevalence of adolescent overweight and obesity (primary objective); BMI reading completeness (primary objective); Distribution of BMI centiles (primary objective); Number of BMI recordings per patient (primary objective); Socio-demographic and clinical baseline characteristics (secondary objective 1); Incidence of comorbidities (secondary objective 2 and exploratory objective 3); Number of all-cause primary care consultations (secondary objective 3 and exploratory objective 3); Cost of all-cause primary care consultations (secondary objective 3); Cost of primary care prescriptions (secondary objective 3); Number of all-cause inpatient admissions (secondary objective 3); Cost of all-cause inpatient admissions (secondary objective 3); Cumulative length of all-cause inpatient stay (secondary objective 3); Number of all-cause outpatient appointments (secondary objective 3 and exploratory objective 3); Cost of all-cause outpatient appointments (secondary objective 3); Number of adolescents with overweight or obesity that were censored due to bariatric surgery (secondary objective 3); Number of all-cause accident and emergency (A&E) attendances (secondary objective 3); Cost of all-cause A&E attendances (secondary objective 3); Number of procedures (secondary objective 3); Cost of procedures (secondary objective 3); Number of primary care prescriptions (secondary objective 4); Treatment patterns (secondary objective 4); Change in body mass index (BMI) (secondary objective 5); Difference in incidence of comorbidities among adolescents with overweight and obesity and healthy weight controls (exploratory objective 1); Difference in healthcare resource use (HCRU) and direct healthcare costs among adolescents with overweight and obesity and healthy weight controls (exploratory objective 1); Difference in long-term comorbidities associated with BMI change (exploratory objective 2); Difference in HCRU and direct healthcare costs associated with BMI change (exploratory objective 2)
Description: Lay Summary
Obesity is the most common long-lasting disease among young people. Obesity, including at a young age, can lead to many health problems such as diabetes, respiratory issues, and liver disease, in addition to mental ill health.
Lifestyle interventions, medication, and weight loss surgery are treatment options. Interventions like diet and exercise are recommended in the first instance. Medications may be offered when lifestyle changes are not successful in reducing weight. Measures such as restricting the placement of less healthy items in supermarkets and in online adverts, calorie labelling on menus, and increasing financial support for school sports to help young people have been introduced.
Studies on obesity at younger ages often group children less than 12 years with those aged 12 and above. Therefore, exact estimates of overweight and obesity in 12-17 year olds are unmonitored. We will use anonymised primary and secondary care health records to determine how many young people are overweight and obese in England. We will also describe the amount of healthcare interaction they have and what health problems they have while young and into adulthood, as well as any treatments they receive from their doctor. This research will provide clinical and public health audiences with insight into overweight and obesity in young people in England that are currently not well defined to help tackle this public health issue.
Technical SummaryObesity is the most common chronic disease among adolescents. Adolescent obesity is associated with significant clinical morbidity including diabetes, orthopaedic problems, respiratory conditions, and fatty liver disease, in addition to mental ill health.
Lifestyle interventions like diet and exercise are the recommended first-line treatments, but studies have shown that severely obese adolescents are reluctant to take part in these interventions. Medications are offered when lifestyle modifications are not successful in limiting weight gain.
The United Kingdom government estimates current costs of obesity to be £6.5 billion, with an additional societal cost estimated at £65 billion. Measures like restricting placement of less healthy items in supermarkets and in online adverts, calorie labelling on menus, and increasing financial support for school sports to help young people have been introduced.
Studies on childhood obesity often group children together with adolescents, e.g., prevalence for ages 2-16 or <18 years, leaving adolescent overweight and obesity prevalence largely undocumented. Additionally, there is a paucity in quantification of multimorbidity and healthcare resource use (HCRU) and cost among overweight and obese adolescents in England.
We will use routinely collected primary, secondary care, and other statistical data from England (i.e., Clinical Practice Research Datalink, Hospital Episode Statistics, and Office for National Statistics death registrations and index of multiple deprivation deciles) to describe prevalence of overweight and obesity per 100,000 adolescents, describe characteristics of adolescents with overweight or obesity using frequency and summary statistics, prevalence of comorbidities using frequency statistics, change in body mass index (BMI) using summary statistics, HCRU and costs using per-person-per-year summary statistics, and treatment patterns using frequency statistics among adolescents aged 12-17 years. We will explore the association between adolescent BMI and change in BMI with adolescent- and adult-onset comorbidities as well as HCRU and costs using Cox proportional hazards regression and generalised linear models, respectively
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Post-operative Iron Deficiency Anaemia in patients undergoing potentially curative surgery for Colorectal Cancer. Analysis of the complications, cancer outcomes and all-cause mortality in anaemic and non-anaemic patients. — Philip Harvey ...
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Post-operative Iron Deficiency Anaemia in patients undergoing potentially curative surgery for Colorectal Cancer. Analysis of the complications, cancer outcomes and all-cause mortality in anaemic and non-anaemic patients.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-10
Organisations:
Philip Harvey - Chief Investigator - University of Birmingham
Alexandra Marley - Corresponding Applicant - University of Birmingham
Matthew Brookes - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of BirminghamOutcomes:
We are interested in comparing the outcomes in patients with anaemia and those without anaemia following their potentially curative resections for colorectal cancer.
Our primary outcomes are: all-cause mortality and cancer recurrence up to 5 years post-discharge.
Our secondary outcomes are: rates of post-operative complications â infections, acute kidney injury, cardiac events and delirium; rate of re-admission to hospital; rate of chemotherapy uptake; and time between surgery and chemotherapy. Rates of complications and readmissions will be assessed within the 3 month period post-discharge. Uptake of chemotherapy will be assessed within 6 months of diagnosis (without evidence (coding) for recurrent / metastatic disease).
Mortality data (all-cause mortality) and cancer recurrence (SNOMED-CT codes) will be obtained from CPRD.
Complications and readmission data will be obtained from HES. The ICD-10 codes are:
Complication Codes
N17 Acute Kidney Injury
I21 Myocardial infarction
J69.0 - aspiration pneumonia NOS
J13 â Pneumonia due to strep pneumonia
J14 - Pneumonia due to Hemophilus influenzae
J15 - Bacterial pneumonia, not elsewhere classified.
J18 âpneumonia (organism unspecified)
N390 Urinary Tract Infection
T814 Surgical site infection
T813 Wound infection
F05. DeliriumFor chemotherapy we will use OPCS4 codes which are:
X35.2 Intravenous Chemotherapy
X38.4 Subcut chemotherapy
X70.1 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 1
X70.2 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 2
X70.3 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 3
X70.4 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 4
X70.5 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 5
X70.8 Other specified procurement of drugs for chemotherapy for neoplasm in Bands 1-5
X70.9 Unspecified procurement of drugs for chemotherapy for neoplasm in Bands 1-5
X71.1 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 6
X71.2 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 7
X71.3 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 8
X71.4 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 9
X71.5 Procurement of drugs for chemotherapy for neoplasm for regimens in Band 10
X71.8 Other specified procurement of drugs for chemotherapy for neoplasm in Bands 6-10
X71.9 Unspecified procurement of drugs for chemotherapy for neoplasm in Bands 6-10
X72.1 Delivery of complex chemotherapy for neoplasm including prolonged infusional treatment at first attendance
X72.2 Delivery of complex parenteral chemotherapy for neoplasm at first attendance
X72.3 Delivery of simple parenteral chemotherapy for neoplasm at first attendance
X72.4 Delivery of subsequent element of cycle of chemotherapy for neoplasm
X72.8 Other specified delivery of chemotherapy for neoplasm
X72.9 Unspecified delivery of chemotherapy for neoplasm
X73.1 Delivery of exclusively oral chemotherapy for neoplasm
X73.8 Other specified delivery of oral chemotherapy for neoplasm
X73.9 Unspecified delivery of oral chemotherapy for neoplasmWe will use recurrent coding to assess cancer recurrence. Patients who were initially coded as having colorectal cancer and then subsequently have a further surgical resection, are coded as having recurrent / palliative disease, are referred to palliative care or after 6 months have chemotherapy (suggesting palliative chemotherapy rather than adjuvant chemotherapy) will be considered in the study to have cancer recurrence.
Description: Lay Summary
Bowel cancer is common. Patients with bowel cancer often have a low blood count called anaemia. Anaemia is caused by the cancer bleeding. Anaemia is often worse after surgery. It can make patients feel tired, weak and out of breath. Anaemia can also make recovery more difficult. Anaemia may cause other things like infections and mean a higher risk of cancer coming back. The immune system is less effective in anaemia. The immune system fights infections and detects/battles cancer.
We want to compare outcomes for anaemic patients who have had surgery to cure their cancer. We want to know if patients with anaemia have more problems after their operations. We also want to know if they wait longer for chemotherapy or are less likely to get it. Finally, we want to know if cancer returns more often, or more quickly in anaemic patents.
This study is important. If anaemic patients have worse outcomes following surgery, we could make treating anaemia more of a priority following surgery.
Technical SummaryColorectal cancer (CRC) is the third most common cancer. Iron deficiency anaemia (IDA) is present at diagnosis in approximately 60% of patients. IDA in the perioperative period is associated with poorer outcomes, including increased cancer recurrence. We will investigate associations of post-operative anaemia on patient outcomes.
We will undertake a retrospective open cohort study of individuals >18 years with CRC and an elective, potentially curative resection as coded by ICD10 codes in HES from 1st Jan 2000 to 31st Dec 2022.
We will extract data on the patientâs haemoglobin at presentation and following surgery (within 6 weeks) from CPRD Aurum dataset. Patients who are anaemic post-operatively will give us the exposed cohort, those who are not anaemic will give us the comparator group. We are adjusting for anaemia at presentation as data suggests this may be a surrogate marker for more advanced disease.
In our groups of CPRD Aurum patients linked to HES admitted patient care data we will examine the association between anaemia in the post-operative period with outcomes. Our research questions are:
When compared to non-anaemic patients do anaemic patients have
1. higher all-cause mortality?
2. higher cancer recurrence?
3. higher rates of post-discharge complications â infections, acute kidney injury, cardiac events and delirium?
4. Higher rate of re-admission to hospital?
5. Reduced rate of chemotherapy?
6. Longer time between surgery and chemotherapy?We will match cohorts by index year of surgery(±2 years), age(±2 years) and gender. We will adjust for year of surgery, age, gender, region, deprivation â practice level IMD, and anaemia at presentation.
We will use Cox proportional hazards regression for survival analysis to look at all-cause mortality and produce KaplanâMeier curves to illustrate cancer recurrence. Rates of post-discharge complications will be analysed as a percentage of total discharges comparing anaemic and non-anaemic patients.
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EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients who Initiated Exenatide as Compared with those who Initiated Other non-Glucagon-Like Peptide 1 Receptor Agonists based Glucose Lowering Drugs — Rachel Armstrong ...
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EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients who Initiated Exenatide as Compared with those who Initiated Other non-Glucagon-Like Peptide 1 Receptor Agonists based Glucose Lowering Drugs
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-14
Organisations:
Rachel Armstrong - Chief Investigator - IQVIA Ltd ( UK )
Ella Baird - Corresponding Applicant - IQVIA Ltd ( UK )
Fabian Hoti - Collaborator - IQVIA Finland Oy
Farokh Master - Collaborator - IQVIA Ltd ( UK )
Giorgi Tskhvarashvili - Collaborator - StatFinn Estonia OU
Sophia Fleming - Collaborator - IQVIA Ltd ( UK )Outcomes:
The primary outcome of interest will be incidence rate; cumulative incidence; and HR of pancreatic cancer in patients exposed to exenatide (BYETTA or BYDUREON/ BYDUREON BCise), compared with exposure to non-GLP-1 RA based GLDs. The secondary outcome of interest will be incidence rate; cumulative incidence; and HR of pancreatic cancer in patients exposed to exenatide once-weekly formulation (BYDUREON/BYDUREON BCise), compared with exposure to non-GLP-1 RA based GLDs.
A sensitivity analysis (sensitivity analysis 7) planned for the assessment of unmeasured confounding will assess incidence rate; cumulative incidence; and HR of lung cancer/ malignant melanoma of the skin (ânegative outcomesâ).Description: Lay Summary
Diabetes (a condition that causes a person's blood sugar level to become too high) is currently one of the major common chronic diseases worldwide and the number of new individuals that are diagnosed is increasing rapidly. If the high blood sugar levels are caused by the body not making enough of a hormone called insulin, or the insulin it makes is not working properly, this is known as type 2 diabetes. Exenatide is a new treatment for type 2 diabetes among adults, used as a combination treatment together with other blood sugar lowering drugs when desirable effects have not been achieved on previous treatments. During the preclinical and clinical development of exenatide, uncertainties were raised around the potential risk for pancreatic cancer. Additional reports have prompted regulatory communications regarding the potential association between exenatide and risk of pancreatic cancer.
Technical Summary
This study will assess the possible risk of pancreatic cancer associated to exenatide use, among patients with type 2 diabetes residing in Europe. Results will be generalisable for the European population of patients with type 2 diabetes using exenatide. Understanding of the treatmentâs safety is important to all individuals using exenatide and also benefits individuals with type 2 diabetes in the UK.The aim of this study is to assess the association between pancreatic cancer and exposure to any exenatide, compared with exposure to non-Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) based glucose lowering drugs (GLDs), among patients with type 2 diabetes mellitus (T2DM), aged 18 years or older. This is an observational, comparative, cohort safety study based on electronically recorded longitudinal secondary databases, collected separately in each of the included 7 countries (France, Spain, Finland, Denmark, Norway, Sweden), including the UK.
The use of CPRD-Aurum, linked to the Hospital Episode Statistics (HES) database, the Office for National Statistics (ONS), and the National Cancer Registration and Analysis Service (NCRAS) databases enables the inclusion of patient-level data for a large number of T2DM patients, including data on drug prescriptions, cancer outcome, medical history, and other clinical characteristics.
The primary objective of this study is to estimate the incidence rate (IR) and hazard ratio (HR) for pancreatic cancer associated with exposure to exenatide (BYETTA or BYDUREON/ BYDUREON BCise), compared with exposure to non-GLP-1 RA based GLDs, among adult patients with T2DM. Included patients will be followed from index date (study entry, 01January 2006) until the end of the study period (31 December 2023), or censoring (outcome of interest, loss to follow-up, emigration, or death), whichever comes first. The latency period for developing pancreatic cancer will be defined as the first 12 months counting from the index date. All analyses will be conducted in the matched study population using an âintention-to-treatâ (ITT) approach, and will be performed separately for each country. The results will be combined using meta-analysis to address the primary and secondary objectives of the study. This post-authorisation safety study (PASS) of exenatide benefits the potential users of this medication, including individuals with T2DM living in the UK.
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Quantifying, Understanding and Enhancing Relational Continuity of Care (QUERCC) — Tom Marshall ...
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Quantifying, Understanding and Enhancing Relational Continuity of Care (QUERCC)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Tom Marshall - Chief Investigator - University of Birmingham
Panagiotis Kasteridis - Corresponding Applicant - University of York
Brian Willis - Collaborator - University of Birmingham
Iestyn Williams - Collaborator - University of Birmingham
Jinyang Chen - Collaborator - University of York
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Sheila Greenfield - Collaborator - University of Birmingham
Zecharias Anteneh - Collaborator - University of YorkOutcomes:
Various Relational Continuity of Care indices; primary care consultations; primary care prescribing; unplanned hospital admissions; A&E presentations; outpatient appointments; primary care costs; secondary care costs; mortality.
Description: Lay Summary
Continuity of care is the extent to which patients see the same doctor or other health care provider over time. Previous research has shown that if patients tend to see the same doctor they have better health and fewer emergency hospital admissions. Despite this, continuity of care in general practices is declining. In this research, we will learn how to improve continuity of care in general practice. To achieve this we have a number of objectives.
Technical Summary
First, there are a number of different ways that practices can measure continuity. We will host two workshops, including patients, and general practitioners to develop a shared understanding of how to measure continuity of care in a way that suits their needs.
Second, we will analyse patient records from a large number of general practices to understand how much continuity is affected by: a) practices becoming larger, b) more doctors working part time, c) patients and doctors moving practice.
Third, we will study a sample of general practices with high continuity in detail. We will organise interviews with staff and patients, to find out how these practices have organised themselves in order to help support continuity of care.
Fourth, we will assess the extent to which practices with higher continuity have lower health service costs, lower hospital admissions, fewer consultations and less prescribing, particularly for patients with long-term conditions.
Fifth, we will host two workshops of doctors, researchers and patients, to draw up practical guidance for general practices that want to increase their continuity.Relational continuity of care (RCC) is the extent to which patients see the same clinicians over time. It is linked to patient satisfaction and better health outcomes, especially for older and vulnerable patients. The overall aim of this project is to develop a deep understanding of how general practices can optimise RCC. We have five objectives.
First, there are different ways of measuring RCC, which reflect different conceptions of RCC between clinicians and patients. We will host consensus workshops of patients, primary care clinicians and researchers to develop a shared understanding of RCC and help practices determine how best to measure and monitor their own RCC.
Second, to understand the drivers of RCC, we will use patient level data from a large number of general practices to model the association between RCC and practice-level characteristics such as staff and patient turnover, part-time working, and practice size and funding per patient. We will then determine which general practices are in the highest decile of relational continuity of care given their characteristics.
Third, we will recruit and study in detail a sample of general practices from this decile. We will explore staff and patient experience of continuity and determine practice policies contributing to RCC, along with barriers and facilitators to their implementation.
Fourth, we will undertake economic analysis to estimate the effects of RCC on resource costs and health outcomes, using linked primary and secondary care data. This will help us understand the likely effects of changing RCC in a general practice and whether these effects vary in different patient groups.
Fifth, we will develop empirically-informed practical guidance to improve continuity of care, collating findings of our quantitative analysis of predictors of RCC, case studies, economic analysis, and existing work on continuity of care in the UK and internationally.
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Evaluation of vaccine effectiveness of maternal pertussis immunisation programme in England — Gayatri Amirthalingam ...
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Evaluation of vaccine effectiveness of maternal pertussis immunisation programme in England
Datasets:GP data, CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-12
Organisations:
Gayatri Amirthalingam - Chief Investigator - UK Health Security Agency (UKHSA)
Jemma Walker - Corresponding Applicant - UK Health Security Agency (UKHSA)
Anna Mensah - Collaborator - UK Health Security Agency (UKHSA)
Emma Heymer - Collaborator - UK Health Security Agency (UKHSA)
Helen Campbell - Collaborator - UK Health Security Agency (UKHSA)
Julia Stowe - Collaborator - UK Health Security Agency (UKHSA)
Nick Andrews - Collaborator - UK Health Security Agency (UKHSA)
Sonia Ribeiro - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
Coverage of pertussis vaccination in women with a live birth according to motherâs age, gestational age (or weeks prior to delivery) at time of vaccination, month of birth and geographic region. This, in combination with UKHSA data on the vaccination status of the mothers of infants with laboratory confirmed pertussis will enable estimation of vaccine effectiveness using the case-cohort (screening) method.
Description: Lay Summary
Whooping cough vaccine in pregnancy was introduced in the UK in 2012, after an outbreak was declared, to protect infants against whooping cough from birth. Young babies are at highest risk of severe disease, needing hospital care and, rarely, dying if they catch whooping cough. Scientists at the UK Health security Agency (UKHSA) have looked before at how well vaccine in pregnancy can protect babies against the disease. This has shown very high protection against whooping cough disease, hospital admission and death in babies whose mothers were vaccinated. Disease levels have been very low in England following the use of measures to control COVID-19 between April 2020-July 2021 but rose quickly after November 2023 across the country in all age groups, including babies. This study will look at the most recent whooping cough cases in babies and young children to compare the vaccine status of their mothers with that of women living nearby who gave birth at a similar stage of pregnancy, in the same month and who were a similar age. From this we can estimate how effectively vaccinating in pregnancy can protect young babies against whooping cough over a recent time. We can also look at whether babies whose mothers were vaccinated in pregnancy respond as well as babies whose mothers were not vaccinated when they receive their own baby vaccines. This work is important so that we can continue to monitor how well the vaccine programme is working and keep this under review in case anything changes.
Technical SummaryOur aim is to estimate the vaccine effectiveness (VE) of maternal pertussis immunisation against laboratory confirmed pertussis in infants using the case-cohort (screening) method. We will estimate the coverage of maternal pertussis vaccine in pregnant women (defined using the pregnancy register) with a live infant born from 1st January 2020 onwards in CPRD Aurum data.
In order to estimate VE, estimates of coverage by month of birth, motherâs age, and geographic region from the CPRD data will be carried forward to use with separate UKHSA laboratory confirmed case data. The aggregated estimates of coverage will be matched to the separate case data on these covariates, and VE will be calculated using the screening method.
Our main objective is to estimate VE against lab confirmed pertussis in those <3 months old (prior to infant scheduled to receive their own vaccinations against pertussis). We will also estimate VE against hospitalisation, and against death.
Exposure in the CPRD Aurum data is maternal pertussis vaccination . The separate UKHSA pertussis case data are the outcome group with the same covariates recorded as the CPRD data.
In response to the increasing laboratory confirmed cases of pertussis being observed across England and 5 pertussis infant deaths reported in the first three months of 2024, UKHSA established a national incident to co-ordinate the response to minimise severe disease and death in infants, at highest risk of disease.
Vaccination remains the key intervention in preventing further severe infant disease, particularly in the first months of life, through the vaccination in pregnancy programme. This has previously been demonstrated to be highly effective in preventing severe infant disease and death, using CPRD data. In light of the increasing pertussis activity including infant deaths, itâs critical to be able to rapidly update current estimates of vaccine effectiveness from the maternal programme.
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Recent trends in primary hypercholesterolemia and mixed dyslipidaemia, ascertainment of low-density lipoprotein cholesterol goals, and the relationship between prescribing of bempedoic acid and outcomes: a descriptive and comparative study — Yasuyuki Matsushita ...
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Recent trends in primary hypercholesterolemia and mixed dyslipidaemia, ascertainment of low-density lipoprotein cholesterol goals, and the relationship between prescribing of bempedoic acid and outcomes: a descriptive and comparative study
Datasets:GP data, CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-27
Organisations:
Yasuyuki Matsushita - Chief Investigator - Daiichi Sankyo Co. Ltd. (Japan)
Alan Fleming - Corresponding Applicant - RTI Health Solutions ( USA )
- Collaborator -
Alistair Gordon - Collaborator - Daiichi Sankyo UK Ltd (UK)
Daniel Robinson - Collaborator - Daiichi Sankyo UK Ltd (UK)
Emma Hawe - Collaborator - RTI Health Solutions ( USA )
Estel Plana Hortoneda - Collaborator - RTI Health Solutions ( USA )
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Katie Houghton - Collaborator - RTI Health Solutions ( USA )
Xingzhu Leng - Collaborator - RTI Health Solutions ( USA )Outcomes:
Primary outcomes
Rate of low-density cholesterol goal attainment; number of primary care appointments identifiable as being associated with cardiovascular disease (CVD); mortality rate; rates of use and uptake of lipid-lowering therapies.
Secondary outcomes
Total cholesterol level; triglyceride level; numbers of urgent referral according to the referral mode; number of primary care appointments.
Description: Lay Summary
Various fats are normally present in the blood, but in some people, the concentration may increase to unhealthy levels. Low-density lipoprotein cholesterol (LDL-C) and triglycerides, 2 types of fats, are commonly evaluated in routine health check-ups. Higher levels of concentration of these fats are associated with higher risk of diseases of the heart and vessels.
There are various treatments and medications that reduce the levels of these fats. These medications are important for reducing the chance of heart disease or vascular diseases such as stroke. Physicians may prescribe individual medications or combinations of medications over time to provide the maximum improvement without causing adverse effects.The proposed study will assess how commonly these fats have occurred at higher levels in the general population since 2019. It will also assess the number of people receiving relevant medications and how often people changed between types of medication.
A new medication, bempedoic acid (BA), was approved in the United Kingdom in 2021. The study will compare outcomes in patients being prescribed BA with those not prescribed BA. It will assess how well BA reduced the levels of LDL-C and how it affected the number of healthcare visits that were made. This information may guide treatment strategies for patients with high levels of LDL-C.
This study will use anonymous data from electronic health records for patients attending general practitioners in England. Researchers will not be able to determine from whom the data originated nor which medical practices contributed.
Technical SummaryPrimary hypercholesterolemia and mixed dyslipidaemia (PH/MD) are characterised by high levels of low-density cholesterol (LDL-C), which are known to be associated with higher risk of cardiovascular disease (CVD). Statins are commonly used to reduce risk for people at high risk of CVD. Alternative lipid-lowering therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, and bempedoic acid may be used because of statin intolerance or because statins are insufficient to reduce LDL-C levels. People not receiving statin alternatives may be at avoidably higher risk of CVD.
Previous work using CPRD data described prevalence, incidence, treatment patterns, achievement of LDL-C goals, and use of resources up to 31 December 2019. This did not cover the time since the National Institute for Health and Care Excellence (NICE) recommended bempedoic acid as a lipid-lowering therapy in April 2021.
This study aims to determine prevalence and incidence of PH/MD over time, treatment patterns, and achievement of LDL-C goals within specified follow-up periods. It will investigate rates of prescribing of lipid-lowering therapies and rates of change between types of lipid-lowering therapies. It will determine the proportion of patients who achieved target LDL-C levels.
The study will evaluate outcomes in patients who received bempedoic acid versus those who did not. The patient group will be those satisfying criteria for eligibility for bempedoic acid according to NICE recommendations. In order to estimate the efficacy of bempedoic acid in these patients, those receiving bempedoic acid will be matched to those not receiving bempedoic acid. Propensity score matching and balance checking will ensure the patient cohorts are comparable. The effect of bempedoic acid use on LDL-C levels, LDL-C target achievement, mortality, and primary care usage will be determined using generalised linear models adjusted for prior LDL-C level, patient characteristics, and prior lipid-lowering medication use.
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An observational analysis of Proton Pump Inhibitors prescriptions and associated morbidity. — Joseph Shalhoub ...
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An observational analysis of Proton Pump Inhibitors prescriptions and associated morbidity.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-25
Organisations:
Joseph Shalhoub - Chief Investigator - Imperial College London
Becker Al-Khayatt - Corresponding Applicant - Imperial College LondonOutcomes:
Primary outcome measures:
The primary outcome of this study will be the association between long term PPI use and rates of previously defined comorbidities:
1)Weight gain (defined as â¥5% increase in body weight).
2)Hypomagnasaemia (defined as serum magnesium measurements of <0.8 mmol/L).
3)Atrial fibrillation (including both paroxysmal and persistent).Secondary outcomes to be measured:
1)Temporal trends of BMI in long-term PPI use between 1997 to 2017.Description: Lay Summary
Proton pump inhibitors (PPIs) are a type of medication that reduce stomach acid production. As a result, they are a commonly used to treat conditions caused by too much stomach acid, such as peptic ulcer disease, or to protect the stomach lining alongside medicines that may irritate it. PPIs are effective in reducing symptoms related to the aforementioned conditions and are considered safe by the wider medical community. However, some studies suggest that long-term PPI use may cause health problems further down the line that are underappreciated by doctors ahead of prescription; these range from direct effects on the gut as well as indirect effects on other organs, such as the heart. Due to a lack of research in this area, these effects are not well understood currently. Our study aims to change this by researching the effects of years of PPI use among patients in the United Kingdom. In particular, we will look into whether long-term use of PPIs are related to weight gain, heart conditions (such as abnormal heart rhythms) and other related measures. Improving our knowledge in this area is likely to trigger further research down the line, which will stands to benefit the general public in several ways: by stopping unnecessary long-term PPI prescriptions, diverting funds to other in-need areas of healthcare, and identifying these medicines as factor in some patientsâ chronic health conditions.
Technical SummaryProton pump inhibitors (PPI) are commonly prescribed for both their significant symptomatic as well as therapeutic benefits (such as in peptic ulcer disease). However, their deleterious effects are rarely appreciated in clinical practice; whilst various studies in the literature have elucidated links to gastric carcinomas and impaired absorption of various electrolytes, the scale of these issues alongside various other potential sequelae of use (including cardiac disease and weight gain) have not been extensively investigated. Therefore, we propose that ubiquitous PPI prescriptions may be associated with significant morbidity; our overarching aims are to study the incidence and prevalence of deleterious effects (which will be considered the primary exposures) related to chronic PPI use such as weight gain, dyselectrolytaemia and/or dysrhythmia. The study population of interest will be adults who are actively taking prescribed PPIs for at least 1 year.
A multivariate statistical analysis will be undertaken to assess the incidence of the aforementioned comorbidities amongst chronic PPI users; they will be actively compared against patients who use histamine 2 receptor antagonists to minimise confounding by indication. Due to multiple covariates being studied, a cox proportional hazards model will be used to investigate the association between chronic PPI use and onset of these conditions. BMI data extracted from the CPRD will be age adjusted and analysed over time to observe temporal weight trends from initiation of prescription, as an exploratory analysis. âHospital Episode Statisticsâ will be used to determine hospitalisations for dyselectrolytaemias and dysrhythmias (e.g. those presenting in atrial fibrillation with a rapid ventricular rate). The bulk of our analysis will be observational by commenting on observed trends, and is therefore speculative. Elucidating a significant burden of deleterious effects secondary to PPI use will ultimately lead to rationalising long-term PPI prescriptions, leading to significant cost savings as well as reducing disease burden.
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Relationship between Hourly Air Pollution and Ambient Temperature with Daily Hospitalization Rates in Asthma Patients: A Time-Series Analysis — Tim Lucas ...
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Relationship between Hourly Air Pollution and Ambient Temperature with Daily Hospitalization Rates in Asthma Patients: A Time-Series Analysis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Tim Lucas - Chief Investigator - University of Leicester
Nidhi Shukla - Corresponding Applicant - University of Leicester
Anna Hansell - Collaborator - University of Leicester
Suzanne Bartington - Collaborator - University of BirminghamOutcomes:
Daily hospitalization counts due to respiratory disease (International Classification of Diseases (ICD)-10 J00-J99) amongst asthma patients.
Description: Lay Summary
Asthma is a common lung condition that occasionally makes it difficult for people to breathe, causing symptoms like coughing and wheezing. Pollution and temperature changes can harm people's health, especially those with asthma. Scientists study how the environment affects health, but comparing different timescales, like hourly pollution and daily health data, was not possible previously. We created a way to combine detailed weather and pollution data with health data, even if they're on different timescales. We want to see how hourly high temperatures and high air pollution levels may affect patients with asthma. Therefore, we aim to study how rapid changes in pollution and temperature affect people with asthma. Unlike typical studies that focus on daily values, we are interested in shorter time-periods, as high levels of pollution or high temperature usually last for only a few hours a day. This research could help people with asthma avoid getting sick when the environment is poor.
Technical SummaryExtreme temperatures and air pollution, particularly high and low temperatures, as well as elevated concentrations of fine particles measuring 2.5 microns or less in diameter (PM2.5), are risk factors linked to exacerbations of asthma symptoms. In exposure-response modeling, environmental epidemiologists often need to aggregate their exposure data, for instance, from hourly to daily, to match the resolution of health data. The aggregation of exposure data results in the loss of available exposure information, which could lead to an underestimation of the impact of extreme environmental exposure on human health. Therefore, we have developed a method called mixed-frequency distributed lag nonlinear models (mfDLNM).
This study aims to estimate the risk of hospitalization among asthma patients for respiratory diseases due to temperature and air pollution at a one-hour temporal resolution, which is rare in the epidemiological literature. Asthma affects over 262 million people globally, and the UK experiences a high burden of morbidity and mortality associated with the condition, with three deaths per day and 60,000 emergency hospital admissions annually [1-3].
We intend to employ mfDLNM, a mixed frequency time series model, to characterise the relationship between daily hospitalization rates for asthma patients and hourly environmental exposures. The daily rate of hospitalization for respiratory diseases among asthma patients in England will be obtained from Hospital Episode Statistics (HES) records linked to CPRD. The exposure information will include hourly PM2.5 and temperature from the UK Automatic Urban and Rural Network (AURN) and modelled data from the Copernicus programme. The study, covering 2010 to 2022, focuses on the time-dependent response to environmental exposures.
This will enable us to identify the hourly risk of hospitalization among asthma patients due to hourly exposure to these variables in England, which will aid in future preventive decision-making during extreme environmental events.
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Examining the epidemiology and mortality of people with psoriasis — Darren Ashcroft ...
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Examining the epidemiology and mortality of people with psoriasis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-07
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Alison Wright - Corresponding Applicant - University of Manchester
Ahmad Khalid Aalemi - Collaborator - University of Manchester
Alexandre de Fatima Cobre - Collaborator - University of Manchester
Christopher Griffiths - Collaborator - University of Manchester
Paul Dimmock - Collaborator - University of ManchesterOutcomes:
Psoriasis incidence, psoriasis prevalence, all-cause mortality, cause-specific mortality, life expectancy.
Description: Lay Summary
Psoriasis is a skin condition, resulting from abnormal activity of the immune system (immune-mediated), which causes inflammation of the skin and sometimes joints. It typically causes a rash with itchy, scaly patches on the skin most commonly on the scalp, elbows and knees, Symptoms of psoriasis can change over time and various factors can cause it to flare-up. There are a range of treatments that can improve symptoms and the appearance of skin patches.
Our previous studies have shown psoriasis affects 2-3% of the UK population and it can either begin before the age of 40 years, categorised as early onset psoriasis, or after 40 years of age known as late-onset psoriasis. We have also shown that, although life expectancy for people with psoriasis is improving, it is still lower compared with people without psoriasis.
This study will provide an update to our previous work examining changes in the number of people with psoriasis and life expectancy between 1999 and 2013, covering a much longer time-period. We will examine for the first time how the number of new cases of psoriasis and the total of people with the disease varies by ethnicity (using the CPRD Ethnicity Record). We will also investigate whether the number of psoriasis diagnoses has been impacted by the COVID-19 pandemic, and whether there have been further changes in life expectancy for people with psoriasis. The findings from this study will inform future policy and clinical practice to help people living with psoriasis across the UK.
Technical SummaryThe proposed study will examine changes in the prevalence and incidence of psoriasis and mortality rates from 1998 to 2023.
Data will be obtained from CPRD GOLD and Aurum from 01/01/1998 to 31/12/2023. The GOLD study population will be linked to deprivation (practice-level Index of Multiple Deprivation (IMD)) data and the Aurum study population will be linked to hospital (Hospital Episodes Statistics), mortality (Office of National Statistics) and deprivation (practice- and patient-level IMD) data. The CPRD Ethnicity Record will be used to categorise ethnicity for all patients in GOLD and Aurum.
Data in GOLD and Aurum will be aggregated into separate years, with the denominator in each year comprising of any acceptable patient registered with a general practice at the start of the year of interest. Annual crude and adjusted prevalence and incidence rates of psoriasis will be estimated and stratified by age, sex, ethnicity, and IMD. Incidence and prevalence will be compared across UK regions and also pre-, during and post-COVID19 pandemic.
In Aurum, a matched (age, sex, ethnicity, general practice) cohort of psoriasis patients (first diagnostic code 01/01/1998-31/12/2022) and up to 5 comparators without psoriasis will be used to examine associations between psoriasis and all-cause and cause-specific mortality. Follow-up of patients will end at the earliest of the study end date (31/03/2023), date of death, practiceâs last data collection date, or transfer out of practice. Cox proportional hazards regression models and competing risks flexible parametric survival models will be used to estimate unadjusted and adjusted all-cause and cause-specific mortality rates. Abridged period life tables will be used to estimate life expectancy and years of life among people with and without psoriasis. Mortality rates and life expectancy will be stratified by age, sex, and ethnicity. Comorbidity patterns will be examined and compared in those with and without psoriasis.
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An observational Cohort study of cardiovascular disease risk in people with Asthma evaluating the role of Leukotriene Receptor Antagonists (LTRAs) — Malcolm Marquette ...
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An observational Cohort study of cardiovascular disease risk in people with Asthma evaluating the role of Leukotriene Receptor Antagonists (LTRAs)
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Malcolm Marquette - Chief Investigator - University of East Anglia
Malcolm Marquette - Corresponding Applicant - University of East Anglia
Allan Clark - Collaborator - University of East Anglia
Andrew Wilson - Collaborator - University of East Anglia
GWYNETH DAVIES - Collaborator - Swansea University
Leo Alexandre - Collaborator - University of East Anglia
Luke Daines - Collaborator - University of Edinburgh
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Incidence of cardiovascular disease events in people with a diagnosis of asthma who are exposed to montelukast; incidence of cardiovascular disease events in people with asthma who were not exposed to montelukast;
Description: Lay Summary
Research is now linking asthma to an increased risk of heart disease. We do not know why this happens. It is very likely that the inflammation of the airways in the lungs, responsible for asthma, contributes to getting heart disease. One of our body's chemicals, called leukotrienes, has been linked to both diseases. Leukotrienes are especially important in some types of asthma. People with asthma are treated using a medication called Montelukast, which blocks them from causing inflammation. There is also some research suggesting that this medication can decrease the risk of heart disease in people with asthma. This research is from small studies, and the follow-up period was short. More importantly, this research does not address the issue of different asthma types. In this study, we want to observe the effects montelukast has on the risk of getting heart diseases, such as heart attacks, angina (heart-related chest pains), and stroke (loss of blood supply to the brain), in a large population of people with asthma from across the United Kingdom (UK). We will do this by accessing patient information found in the Clinical Practise Research Datalink (CPRD), which contains information about people with asthma spanning almost three decades. We will look back at this information and work out if taking montelukast decreases the risk of heart disease. Moreover, we will have the opportunity to study the risk of heart disease in the asthma population, which will help us make observations on those people who are at increased risk.
Technical SummaryObservational studies have linked asthma to an increased cardiovascular disease (CVD) risk. The mechanisms for this need to be clarified. Asthma is a complex disease comprising different phenotypes with distinct endotypes. Most of the observational studies so far still need to address this problem. A possible candidate for asthma, and CVD association, is the Leukotrienes, these products of metabolism of the 5-Lipoxygenase (5-LO) pathway. These lipid mediators cause inflammation in both airways and blood vessels, and some phenotypes of asthma have a high leukotriene status. Leukotriene Receptor Antagonists (LTRAs, e.g., Montelukast), used in asthma, target leukotriene activity. A recently published small study suggests that montelukast decreases the incidence of CVD in patients with asthma, with a risk reduction of 76% (n=400).
This retrospective cohort study will evaluate montelukast's effect on CVD risk by measuring the incidence of ischaemic heart disease and stroke in the asthma population. We will interrogate data from the Clinical Practise Research Datalink (CPRD) GOLD from the database inception until January 2023 with HESAPC data linkage. Our feasibility counts show that there are a total of 722730 patient records with a diagnosis of asthma, and 88387 of these have a prescription for montelukast. The analysis will be a Cox proportional regression with time-dependent exposures, which will estimate the associations between LTRAs use, compared to no LTRAs use, after diagnosis with asthma, on CVD incidence. To account for confounders, propensity score matching will be used to evaluate the probability of receiving LTRAs. This will be the case for covariates where the amount of missing data is at most 30%. Logistic regression will be used to generate propensity scores.
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Surgery Waiting Times and Healthcare Resource Use by Body Mass Index in Patients with Osteoarthritis — Caroline Casey ...
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Surgery Waiting Times and Healthcare Resource Use by Body Mass Index in Patients with Osteoarthritis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Caroline Casey - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Zohaib Akhter - Corresponding Applicant - Adelphi Real World
Alun Davies - Collaborator - Eli Lilly & Co - UK
Laurienne Edgar - Collaborator - Eli Lilly & Co - UK
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Thomas Jennison - Collaborator - Adelphi Real WorldOutcomes:
Time-to-first referral to orthopaedic specialist; time-to-first orthopaedic specialist consultation; time-to-first TJA surgery; healthcare resource use (primary care consultations; outpatient attendances; inpatient stays; A&E visits; physiotherapy and counselling services; and prescriptions written in primary care); all-cause healthcare costs (by care setting and total); change in BMI classification; all-cause mortality; socio-demographic and clinical characteristics.
Description: Lay Summary
Osteoarthritis (OA) is a disorder that causes wear and tear of joints which leads to pain, stiffness, and limited mobility. In the UK, OA affects approximately 10 million people, with 5.4 million and 3.2 million affected by OA of the knee and hip, respectively.
Technical Summary
Whilst there is no cure for OA, symptoms are managed through a combination of drug treatments, lifestyle changes and supportive therapies to ease everyday activities. In severe cases, where daily life is seriously affected, surgery is recommended to replace the joint with artificial parts through a joint replacement surgery. However, access to this surgery is not equal, depending upon ethnicity, living in deprived areas which affects access and time spent on surgery waiting lists, and subsequently healthcare service use. Patient weight limits are also in place for accessing surgery which are often difficult to achieve and further increase the inequalities.
Little research has been conducted in the UK assessing the time OA patients spend on waiting lists for joint replacement surgery, the healthcare services used during waiting times, and how patientsâ weight impacts their care pathway. Through this study we aim to address these research gaps by describing the characteristics of patients diagnosed with OA of the knee or hip, time spent on surgery waiting lists, and healthcare services used from OA diagnosis through to surgery. We will also explore these further by ethnicity, geographical region, and level of deprivation, with the aim to advise clinical decisions for treating and managing patients with OA.Aim: To evaluate waiting times and healthcare resource use (HCRU) and costs of patients with newly diagnosed knee or hip osteoarthritis (OA) awaiting total joint arthroplasty (TJA) in England.
Objectives: To describe i) waiting times and HCRU/costs from initial OA diagnosis to orthopaedic specialist referral, consultation and TJA surgery, by body mass index (BMI); ii) the proportion of patients changing BMI subgroup prior to TJA surgery, by pharmacological and lifestyle interventions, and comorbid type 2 diabetes; iii) baseline socio-demographic and clinical characteristics, by BMI. Waiting times prior to TJA surgery will be stratified by index year, ethnicity, geographic region, and socioeconomic status.
Methods: Retrospective cohort study of adults newly diagnosed with OA of the knee or hip between 2017-2018 (indexing period) using linked primary care (CRPD Aurum) and secondary data (HES). A minimum of 12-monthsâ data pre-index is required for inclusion, with variable follow-up (maximum 5-years with study period end of 31st December 2023). Patients with prior joint replacements or private healthcare will be excluded.
Exposures: OA of the knee or hip, BMI (at OA diagnosis), pharmacological and lifestyle interventions following OA diagnosis.
Outcomes: Time-to-first referral to orthopaedic specialist, time-to-first orthopaedic specialist consultation, time-to-first TJA surgery, HCRU/ costs, change in BMI, mortality, socio-demographic and clinical characteristics.
Data Analysis: Counts, mean, standard deviation, medians, interquartile range and minimum/maximum values will be reported for numeric variables; frequencies and proportions for categorical variables. Rates will be calculated by dividing frequency of events by person time at-risk. Kaplan-Meier plots visualising time-to-events and Kaplan-Meier estimates of survivor function and cumulative hazard rate will be outputted.
Public benefit: Waiting times for joint replacement surgery among OA patients will be reported according to BMI groups, ethnicity, socioeconomic status and geographical regions. As such, care disparities may be found, providing evidence to optimise management and resource allocation.
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Investigating the impact of serum potassium levels on clinical outcomes and treatment management strategies for patients with hyperkalemia in UK clinical settings: an observational study (SPECTRA) — Benjamin Heywood ...
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Investigating the impact of serum potassium levels on clinical outcomes and treatment management strategies for patients with hyperkalemia in UK clinical settings: an observational study (SPECTRA)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-10
Organisations:
Benjamin Heywood - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ewan Laws - Collaborator - AstraZeneca Ltd - UK Headquarters
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Jil Billy Mamza - Collaborator - AstraZeneca Ltd - UK Headquarters
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Shikta Das - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
Patient characteristics, treatment patterns, Serum potassium levels, co-morbidities at baseline; clinical outcomes (MACE/all-cause death/all-cause hospital admissions/eGFR decline) and associated health care resource utilisation; comparison of proportions between SZC-treatment vs non-treated and RAASi dose; distribution of disease occurrence, treatment patterns/drug utilisation and characteristics of patients attaining GDMT and associated HCRU.
Description: Lay Summary
Hyperkalemia refers to increased potassium levels in the blood which if untreated can lead to other health conditions such as heart attacks. People with kidney disease are at increased risk of hyperkalemia as the kidneys do not remove adequate levels of potassium from the blood. People with heart failure are also at risk as some heart failure medications may lead to an increase in potassium levels. In this study, we wish to select patients with a blood potassium level recorded and to present patient characteristics, and treatment and disease patterns. We aim to describe the relationship between different levels of potassium and the risk of events such as heart attacks, strokes and death. We will the number of patients with high levels of potassium that are treated in general and also those treated with a specific drug of interest. Understanding the risk of events such as heart attacks, strokes and death within this population will help us to better understand the effects of different potassium levels and may contribute to improvements in the management of potassium levels across the UK. In addition, understanding the treatment patterns will help understand any unmet need in patients with a high potassium level benefiting the public health in the UK.
Technical SummaryThe incidence of Hyperkalemia (HK) in adults in England has been estimated as 2.86 per 100 person-years and is characterized by a serum potassium (SK) level between 5.0 and 5.5 mmol/L (inclusive). HK is associated with a significant healthcare burden due to frequent hospitalization and recurrent episodes, indicating the importance of understanding potential adverse outcomes associated with HK and the optimal renin-angiotension-aldosterone system inhibitor (RAASi), dose by SK level.
This is an observational retrospective cohort study which will assess four primary objectives through the use of Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) data. These objectives are (1) to describe patient characteristics and treatment patterns stratified by demography, SK levels, and co-morbidities at baseline; (2) to describe the association between SK levels and clinical outcomes (major adverse cardiac events (MACE)/all-cause death/all-cause hospital admissions/eGFR decline) and their associated healthcare resource use; (3) to demonstrate the ability to maintain optimal RAASi dose by SK level through the use of sodium zirconim cyclosilicate (SZC) (i.e. quantify how many patients on SZC actually discontinue, down titrate, and/or return to optimal RAASi dose, time to return to optimal dose) and (4) to describe patient characteristics and healthcare resource utilization (HCRU) in individuals with comorbid heart failure and chronic kidney disease who are receiving guideline-directed medical therapy (GDMT), stratified by the initiation vs non-initiation of any HK management strategy. The findings from this study will contribute to the body of knowledge surrounding patient management, treatment strategies, and the impact of hyperkalemia on clinical outcomes and HCRU.
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Impact of Mode of Consultation on Antimicrobial Prescribing and Health Complications for Urinary Tract Infections in Primary Care in England — Igor Pantea ...
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Impact of Mode of Consultation on Antimicrobial Prescribing and Health Complications for Urinary Tract Infections in Primary Care in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-19
Organisations:
Igor Pantea - Chief Investigator - UK Health Security Agency (UKHSA)
Igor Pantea - Corresponding Applicant - UK Health Security Agency (UKHSA)
Alicia Demirjian - Collaborator - UK Health Security Agency (UKHSA)
Angela Falola - Collaborator - UK Health Security Agency (UKHSA)
Diane Ashiru-Oredope - Collaborator - UK Health Security Agency (UKHSA)
Donna Lecky - Collaborator - UK Health Security Agency (UKHSA)
Hanna Squire - Collaborator - UK Health Security Agency (UKHSA)
Mehdi Minaji - Collaborator - UK Health Security Agency (UKHSA)
Sabine Bou-Antoun - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
- Monthly proportion of remote and face-to-face consultations for UTI that resulted in an antibiotic prescription (numerator) relative to the total number of remote and face-to-face consultations for UTI (denominator).
- Probability of an antibiotic prescription where a remote or face-to-face consultation is a binary co-variate
- Probability of a recurrent UTI where a remote or face-to-face consultation and an antibiotic prescription are binary exposures
- Probability of a hospital admission after three months following a consultation for UTI where a remote or face-to-face consultation and an antibiotic prescription are binary exposures
- Probability of an out-patient visit after three months following a consultation for UTI where a remote or face-to-face consultation and an antibiotic prescription are binary exposures
- Probability of a visit at an A&E department after three months following a consultation for UTI where a remote or face-to-face consultation and an antibiotic prescription are binary exposures
- Probability of a death episode after six months following a consultation for UTI where a remote or face-to-face consultation and an antibiotic prescription are binary exposuresDescription: Lay Summary
Remote consultations by general practitioners (GPs) have been increasing in number, a process which accelerated during the COVID-19 pandemic due to the need to reduce person-to-person virus transmission. Post-pandemic, they are especially useful when face-to-face presents risks or difficulties, such as in the case of immune-compromised patients. However, there is a need for more research to assess how this transition impacted the delivery of health services.
One of the concerned areas is antimicrobial prescribing. With the developing antimicrobial resistance crisis where resistance of microbes to drugs outpaces the discovery of antibiotics, there were increasing efforts to promote more responsible prescription and consumption of antibiotics. The study focuses specifically on prescriptions for urinary tract infections in primary care, and what are the key differences of antimicrobial prescribing for remote versus in-person consultations. Secondly, it will be investigated if they result in unintended outcomes, such as infection recurrence, accident and emergency department visit, out-patient visits, hospitalisation, or death. This is achieved using historical data in England between 2019 and 2023. Patient circumstances, such as age, sex, deprivation level, urbanicity, infection type or co-occurring health problems are accounted for to allow a non-biased comparison of the groups.
The findings will show if remote consultations in primary care impact prescribing patterns and the efforts to combat antimicrobial resistance versus in-person visits. Additionally, it will also allow practitioners and public authorities to have empirical knowledge for recommendations about the suitability of remote consultations and how their delivery can be improved taking into account personal circumstances.
Technical SummaryA recent study found that remote consultations for acute respiratory infections (ARI) were 23% more likely to result in antibiotic prescription in adults, which impacts the UK ambition to reduce community antibiotic prescribing by 25% against a 2013 baseline. We propose to investigate the antibiotic prescribing patterns for remote versus face-to-face consultations in primary care for urinary tract infections (UTI) to assess how remote delivery impacts prescribing patterns for UTI, and, secondly, to assess its impact on the likelihood of hospital admissions (Hospital Episode Statistics (HES) Admitted Patient Care), out-patient visits (HES Outpatient), accident and emergency (A&E) admission (HES Accident and Emergency), or death (ONS Death Registration Data).
The use of five yearsâ worth of national general practitioners (GP) practice data in England will reflect fluctuations in infection burden, antibiotic prescribing, delivery mode and antimicrobial stewardship (AMS) during 2019-2023. Simultaneously, patient information, such as age, sex, comorbidities (e.g., diabetes), UTI type (lower/upper), as well as deprivation level (Patient Level Index of Multiple Deprivation) and urbanicity (2011 Rural-Urban Classification at LSOA level) will be predictors of outcome. The outcomes are the likelihood of a UTI consultation, whether remote or face-to-face, to follow with: antibiotic prescription, recurrent UTI, out-patient visit, hospital admission, A&E visit, or death episode. The main statistical method is mixed effects logistic regression modelling.
This research will provide an understanding of the impact and implications of mode of consultation on antibiotic prescribing and health complications for patients, allowing to further improve the delivery of health services. It may inform on the appropriateness of prescribing, which is essential for future policies in promoting AMS and combating the antimicrobial resistance crisis. Additionally, as antibiotics are frequently associated with side effects, reducing the factors in remote consultations that predispose to unnecessary prescribing will allow for an increase in patient quality of life.
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Epidemiology and interventions to improve the long-term morbidity and mortality in people with obesity — Francesco Zaccardi ...
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Epidemiology and interventions to improve the long-term morbidity and mortality in people with obesity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-17
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Suhail Shiekh - Corresponding Applicant - University of Leicester
Cameron Razieh - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Navjot Kaur - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of Leicester
Tom Yates - Collaborator - University of Leicester
Yijing Chen - Collaborator - University of LeicesterOutcomes:
(i) Fatal and non-fatal complications that have been deemed relevant in the investigations of obesity, including but not limited to cardiovascular and metabolic diseases and cancers.[1] The absolute and relative risks of these complications over time, as well as of mortality, will be estimated within individuals in relation to BMI, bariatric surgery, medical/drug interventions for obesity, and other individual level characteristics (including sociodemographic). (ii) Change in the risk factors before and after bariatric surgery and medical/drug interventions.
The main complications (primary outcomes) of interest are:
-Hypertension (also a risk factor)
-Type 2 diabetes (also a risk factor)
-Cause-specific and all-cause mortality
-Cardiovascular diseases (e.g., heart failure, myocardial infarction, atrial fibrillation, peripheral arterial disease)
-Cerebrovascular disease (e.g., stroke)
-Kidney disease
-CancersWe will also investigate (secondary outcomes):
- Variations in lipid disorders (also a risk factor)
- Variations in glucose levels (also a risk factor)
-Variations in BMI/body weight over time
-Mental health (e.g., depression, anxiety)
-Neurological (e.g., dementia, Alzheimerâs disease, Parkinsonâs disease)
-Respiratory (e.g., asthma, chronic obstructive pulmonary disease)
-Musculoskeletal (e.g., osteoporosis, rheumatoid arthritis)Potentially some additional complications and risk factors could be included based on discussions with the study team which includes epidemiologists and clinicians working on research and treatment of obesity-related outcomes, to determine real world relevance in relation to obesity. Furthermore, we will be considering the rapidly evolving research area of multiple long-term conditions to define potentially relevant clinical conditions as complications/outcomes.
Description: Lay Summary
Obesity, is a determinant of health and a leading cause of diseases and premature death globally. Overweight and obesity, defined as abnormal or excessive fat accumulation that presents a risk to health, have been shown to increase the risk of heart attacks, high blood glucose levels (Type 2 diabetes), certain cancers and death. Complication development may occur more frequently and sooner in those with obesity. The type of complications (e.g., heart disease) may vary as well. At the same time, a risk factor common in people with obesity, e.g., high blood pressure, may also play a different role in the development of diseases or death. There may be differences in outcomes and obesity related-complications by sociodemographic characteristics. For example, it has been reported that there are marked ethnic differences in the development of diseases in relation to obesity, suggesting BMI as an important determinant of health inequality within minority groups. Prevalence of obesity is also higher in those who are more deprived. Using CPRD data, this study aims to explore the trajectories of risk factors, complications and mortality in individuals with obesity, compared to non-obese patients; and to explore how the diseases of the vessels and cancer vary by age, sex, ethnicity, and deprivation, and in relation to intervention to reduce body weight, such as bariatric surgery or medications. These analyses will add to the body of knowledge on obesity and related interventions, thereby improving patient care either directly or indirectly by informing clinical practice guidelines and/or public health policy.
Technical SummaryThere is limited evidence detailing the natural history of obesity sequelae from diagnosis as measured by body mass index (BMI), and how this history is influenced by the characteristics of patients or by medical or surgical interventions. To explore the intersectionality in obesity trajectories, complications and mortality by age, sex, ethnicity, and deprivation, using CPRD Aurum data linked to hospital admissions and death registry data, we will conduct a cohort study of patients aged 16 and over with a recorded BMI between January 2000 and June 2024. We will also develop two matched sub-cohorts for patients who had bariatric surgery, and obesity medications, matched to those who did not. We will investigate the development of a single and multiple diseases in individuals across levels of BMI and compare trajectories in relation to risk factors which can interact with obesity, such as deprivation, smoking, and medications. We will investigate how the longitudinal changes of BMI, including through interventions such as bariatric surgery or medications, may impact on the development of diseases and how BMI and the risk of cardiovascular diseases and cancers has changed over time. Associations with a single disease (monomorbidity) or multiple diseases (multimorbidity), as well as mortality, will be evaluated in both relative and absolute risks. Using time-to-first-event analysis, parametric (i.e., Royston-Parmar), semi-parametric (i.e., Cox), and non-parametric (i.e., Kaplan-Meier) survival analysis and multilevel models, and sensitivity analyses we will examine the association between obesity interventions, such as bariatric surgery and medications, on different risk factors and morbidity/mortality outcomes, exploring interactions by age, sex, ethnicity and deprivation, and develop models to predict the outcomes in relation to patientsâ characteristics and medications/bariatric surgery. This study using the UKâs EHR data will lead to a better understanding of the factors that contribute to health of people in the UK.
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Assessing the Availability and Completeness of Alternative Measurements in Routinely Collected Breast Cancer Patient Data: A Feasibility Study — Dorcas Kareithi ...
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Assessing the Availability and Completeness of Alternative Measurements in Routinely Collected Breast Cancer Patient Data: A Feasibility Study
Datasets:GP data, NCRAS Tumour / Treatment data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-07
Organisations:
Dorcas Kareithi - Chief Investigator - Newcastle University
Dorcas Kareithi - Corresponding Applicant - Newcastle University
James Wason - Collaborator - Newcastle University
Jingky Lozano-Kuehne - Collaborator - Newcastle UniversityOutcomes:
Type of tumour; tumour size; quality of life; comorbidity score; tumour screening; tumour treatment; cancer stage; demographic characteristics
Description: Lay Summary
The number of new cases and daily breast cancer-related deaths are projected to increase significantly, even with new treatments. The common way to evaluate treatments is through clinical trials. However, these take about 6 years, cost about £2 million, and often struggle to get participants. Observing globally accepted information in trials therefore becomes challenging. This study seeks to assess the feasibility of using demographic characteristics, diagnoses and symptoms and referral data, linked with cancer registration and treatment data from CPRD to examine measurements which can predict how cancers are progressing and the effect of any treatment.
Specifically, in this study we will examine the patient demographic characteristics, proportion of patients with a breast cancer diagnosis, how often measurements on tumour sizes, quality of life and morbidity-related measurements are taken during follow-up visits for different breast cancer type patients
We will examine anonymized data from patients were over 18 years old and received a breast cancer diagnosis between 2005 and 2018, and are based in England.
The findings from this study will provide insights into what variables and methods will be used for my NIHR Doctoral fellowship application that seeks to improve the efficiency of clinical trials through alternative measurements found in female breast cancer data in registries.
Technical SummaryThe number of new cases and daily breast cancer-related deaths are projected to increase significantly, even with new treatments. The standard way to evaluate treatments is through clinical trials. However, these take long (average 6 years), are costly (average £2 billion), and face recruitment challenges. This makes observation of globally accepted endpoints in such trials challenging. Emphasis is shifting to alternative measures that provide more information on disease progression and can predict patientsâ survival throughout a study. These measures can be found in demographic characteristics, diagnoses and symptoms and referral data, which can be linked to tumours and is available in registries.
Extensive reviews of evidence shows that the use of registry data in trials depends on data structure and completeness. This study will examine the Cancer Registration and Treatment data that is linked with demographic characteristics, diagnoses and symptoms and referral data for possible measurements that can be used as proxies to patient survival, tumour progression and quality of life for different breast cancer patients.
Specifically, we will examine
⢠Proportion of patients with a diagnosis of the different breast cancer types and their demographic characteristics
⢠Proportion of patients with at least 2 years of follow-up following diagnosis
⢠Time between tumor, quality of life and morbidity-related measurements for each breast cancer type
⢠Size of the tumors for each breast cancer type at diagnosis and at follow-upAnonymized data from patients who were over 18 years old and received a breast cancer diagnosis between 2005 and 2018, and are based in England will be analysed.
The findings from this study will provide insights into what variables and methods will be used for my NIHR Doctoral fellowship application that seeks to improve the efficiency of clinical trials through alternative measurements found in female breast cancer data in registries.
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Prognosis, management and health inequalities of valvular heart diseases in the UK — Jianhua Wu ...
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Prognosis, management and health inequalities of valvular heart diseases in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Jianhua Wu - Chief Investigator - Queen Mary University of London
Harriet Larvin - Corresponding Applicant - Queen Mary University of London
Chris Gale - Collaborator - University of Leeds
Ramesh Nadarajah - Collaborator - University of Leeds
Rohan Devani - Collaborator - Barts and the London Queen Mary's School of Medicine and DentistryOutcomes:
Valvular heart disease incidence; cardiovascular* and non-cardiovascular** related hospital admission and diagnostic events; surgical procedures; blood transfusion.
*including hypertension; stroke; heart attack; ischemic heart disease; heart failure.
**including anaemia; arthritis; pneumonia; renal failure; liver disease; cancer; dementia.Description: Lay Summary
Valvular heart diseases (VHD) occur when the valves of the heart don't work properly. They are influenced by various factors like age, gender, and socioeconomic status. As the population ages in the UK, it's expected that more people will develop VHD. However, access to healthcare may not be equal for everyone, leading to differences in how VHD is treated and managed.
This project aims to use national health data to study VHD in the UK. By combining statistics and data science methods, researchers will look into how VHD affects different groups of people. The goal is to understand how health inequalities impact the outcomes of VHD and develop better strategies for prevention and management.
The main goals of this research are:
To see how the number of cases of VHD has changed over time.
This will help understand how VHD is affecting the population, especially considering recent events like the COVID-19 pandemic.To explore other health conditions that are linked to VHD.
By looking at connections between different health issues and VHD, we can improve how we care for people with VHD.To understand what happens to people after they're diagnosed with VHD.
Using advanced statistical and data science techniques, researchers will explore how outcomes may vary amongst different groups of people with VHD, for example by age, sex, ethnicity and deprivation.Overall, this project aims to shed light on how VHD affects people in the UK and find ways to reduce the impact of health inequalities on VHD care.
Technical SummaryValvular heart diseases (VHD) manifest as malfunctioning of the heart valves. VHD are multifactorial and have a complex aetiology; age, sex and deprivation are notable risk factors. Incidence of VHD will increase alongside the ageing population in the UK, and disparities in access to healthcare will widen inequalities in prognosis and care of the condition.
This project will utilise national data from CPRD and combine statistics and data science to explore the trends and outcomes of VHD, with additional analysis through the lens of health disparities. The output of this project will support new strategies for the prevention and management of valvular heart disease and mitigate the impact of health inequalities.
The research aim is to study the trends and outcomes of VHD in the UK.
The specific objectives are:
1) To investigate the temporal trends in incidence and prevalence of VHD.
The findings will show changes in incidence and prevalence of VHD over time to indicate the burden in the UK using primary and secondary care data. Subgroup analyses by age, sex, ethnicity, and deprivation will show disparities in the trends of VHD across patient groups.
2) To explore the comorbidities associated with VHD.
This objective will utilise AI network analysis (hypergraphs) to reveal more about the pattern of disease profile of patients with VHD using data from primary care and admitted patient care. Secondary analyses will show how the clinical needs of patients with VHD are different amongst patient groups.
3) To quantify the adverse clinical outcomes following diagnosis of VHD.
This objective will use machine learning (unsupervised cluster analysis)of demographic and clinical data to reveal phenotypes of VHD. Quantification of outcomes across clusters using Cox proportional hazard modelling will reveal inequalities of health outcomes across different patient groups.
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Assessment of the long-term outcomes among patients living with obesity at the point of diagnosis of type 2 diabetes through a cohort study and target trial emulation — Michail Katsoulis ...
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Assessment of the long-term outcomes among patients living with obesity at the point of diagnosis of type 2 diabetes through a cohort study and target trial emulation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-19
Organisations:
Michail Katsoulis - Chief Investigator - University College London ( UCL )
Benjamin Norton - Corresponding Applicant - University College London ( UCL )
James Bailey - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Victoria Yorke-Edwards - Collaborator - University College London ( UCL )Outcomes:
Primary outcome(s)
The following primary outcomes will be used for both the cohort study and target trial emulation:
⢠Number of major adverse cardiovascular events (defined as a non-fatal myocardial infarction, coronary artery disease, coronary artery stenting, coronary artery bypass grafting, non-fatal stroke, or cardiovascular death) at 5- and 10-years. ⢠All-cause mortalityThese represent hard outcomes that are more easily coded and analysed than surrogate markers of diabetic control and weight loss.
The following secondary outcomes will be used for the cohort study:
⢠Average level of HbA1c (mmol/mol) at 5- and 10-years after the diagnosis of T2D.
⢠Average difference in HbA1c (mmol/mol) between baseline (at diagnosis) and 5- and 10-years.
⢠Average number and dose of oral anti-diabetic medications being used at 5- and 10-years after the diagnosis of T2D.
⢠Average difference in the number and dose of oral anti-diabetic medications being used between baseline (diagnosis) and 5- and 10-years.
⢠Proportion of patients taking insulin at 5- and 10-years after the diagnosis of T2D.
⢠Average BMI at 5- and 10-years after the diagnosis of T2D.
⢠Average difference in BMI between baseline (diagnosis) and 5- and 10-years.
⢠Proportion of patients with a BMI above the following thresholds at 5- and 10-years:
o BMI â¥30 kg/m2.
o BMI â¥35 kg/m2.
o BMI â¥40 kg/m2.
⢠Number of patients with at least stage 4 chronic kidney disease (defined by an eGFR <30 ml/min/1.73 m2 or need for dialysis) at 5- and 10-years after the diagnosis of T2D.
⢠Number of hospital hospital admission, bed days, and critical care use (HES APC linked data)
⢠Number of patients undergoing at least one lower limb amputation at 5- and 10-years after the diagnosis of T2D.
⢠Number of patients diagnosed with anxiety and/or depression at 5- and 10-years after the diagnosis of T2D.
⢠Number of patients undergoing bariatric surgery (defined as sleeve gastrectomy, gastric bypass, or gastric band) at 5- and 10-years after the diagnosis of T2D.The following secondary outcomes will be used for the target trial emulation:
⢠Proportion of patients achieving a BMI ⤠25 kg/m2 after 5-years and 10 years
⢠Proportion of patients achieving a BMI < 30 kg/m2 after 5-years and 10 years
⢠Proportion of patients achieving a BMI ⤠35 kg/m2 after 5-years and 10 years
⢠Average time (days) to achieve a BMI ⤠25 kg/m2
⢠Average time (days) to achieve a BMI < 30 kg/m2
⢠Proportion of patients achieving a HbA1c ⤠48 mmol/mol after 5-years and 10 years
⢠Proportion of patients achieving a HbA1c < 53 mmol/mol after 5-years and 10 years
⢠Proportion of patients in the standard or intensive medical therapy groups who subsequently undergo bariatric surgeryDescription: Lay Summary
Type 2 diabetes (T2D) is a major health problem in the UK. It is due to abnormally high blood sugar levels and directly linked to increased body fat (e.g. obesity). When people living with obesity develop T2D it is known as âdiabesityâ, and the numbers are expected to significantly rise in the coming years. This is concerning given that both obesity and T2D can cause long-term damage to bodily organs such as the brain, heart, liver, and kidneys. The treatment of diabesity involves making changes to a personâs lifestyle to induce weight loss, which can then be combined with medication or even surgery. Despite this advice, weight loss is hard to achieve and maintain for many people. Our concern is that most people with diabesity are unable to obtain a healthy weight and get good control of their diabetes leading to chronic health problems and high healthcare costs and utilisation. If this is true, then we need to reconsider how we treat the condition, especially early on. In our study, we will look at what happens to people over ten years after they are first diagnosed with diabesity. We will do this by looking at changes in their weight, blood tests, and health conditions using data routinely recorded by general practitioners. We will then assess what treatments people had to see which are more effective at improving weight loss, controlling T2D, and preventing organ damage. This will help us develop better treatment pathways to prevent long-term problems and healthcare costs.
Technical SummaryType 2 diabetes (T2D) is a major public health burden directly linked to high body mass index (BMI). The combination of T2D and obesity is termed âdiabesityâ, which is a major risk factor for many conditions including cardiovascular disease. Despite anti-diabetic medications, many patients remain overweight with poor diabetic control and the estimated annual rates of weight normalisation among obese individuals is <1%. Bariatric surgery is the most effective treatment for obesity with profound anti-diabetic effects. However, <1% of suitable patients undergo surgery, and it is not scalable. Consequently, novel endoscopic treatments and medications have been developed that could be introduced earlier, and in combination. However, we first need to define the long-term problems to warrant future research.
A UK cohort study will be conducted looking at long-term health outcomes among patients living with obesity at the point they are diagnosed with T2D between 2005-2023. CPRD data, including deprivation and ethnicity, will be analysed over 10-years from the point of T2D diagnosis. We hypothesise most patients will not regain normal BMI, have ongoing poor diabetic control, and have adverse health outcomes including major cardiovascular events. Primary outcomes will be major cardiovascular events and mortality. Secondary outcomes will look at changes in HbA1c, number and use of anti-diabetic medications, biometric data, and adverse health outcomes. Regression models will be used to determine relationships between outcomes and covariates. Results will provide the foundation for future research into early, intensive treatment for diabesity as âtop-downâ strategies to reverse diabetes and achieve weight loss. To emulate this future prospective research, we will conduct a target trial emulation to assess the impact of treatment allocation to bariatric surgery, intensive medical therapy, or standard medical therapy within the first 18 months of diabesity diagnosis. Primary outcomes will be major cardiovascular events, cardiovascular death, and all-cause mortality.
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A cohort study to investigate the use of social prescriptions in England and to describe patterns of healthcare use, prescribing and health outcomes following a social prescribing referral — Anita McGrogan ...
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A cohort study to investigate the use of social prescriptions in England and to describe patterns of healthcare use, prescribing and health outcomes following a social prescribing referral
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-07
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Estelle Corbett - Corresponding Applicant - University of Bath
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Julie Barnett - Collaborator - University of Bath
Saoirse Fitzgerald - Collaborator - University of BathOutcomes:
Healthcare use
⢠Total number of primary care healthcare appointments
⢠Referrals to secondary care
⢠âDid not attendâ primary care appointments
Prescribing
⢠Number of prescriptions for antidepressants, anxiolytics, hypnotics or other mental health prescribing.
⢠Number and profile of prescriptions for pain management
⢠Number of prescriptions for hypertension, diabetes, and total number of prescriptions for long term conditions.Health outcomes
⢠Incidence of new common mental health condition (first record of a diagnosis or symptom of depression or anxiety)
⢠Incidence of new diagnosis of diabetes
⢠Among patients with a baseline diagnosis of diabetes, glycaemic control (HbA1C level)
⢠Incidence of new diagnosis of hypertension
⢠Among patients with a baseline diagnosis of hypertension, blood pressure control (blood pressure levels)
⢠Incidence of falls
⢠Warwick Edinburgh Wellbeing scoreDescription: Lay Summary
Social prescribing is a new approach that aims to improve individuals' health and wellbeing by addressing non-medical needs such as loneliness. Social prescribing initiatives running in Englandâs National Health Service typically involve healthcare professionals referring people who might benefit from a non-medical community service to a âlink workerâ. The link worker will then meet with the patient to find out what support they need, develop an action plan together, and link the patient to the relevant community resources. This approach aligns with a shift towards recognising the impact of wider social, economic, behavioural and environmental factors affecting health and aims to address the rising issue of overmedication.
It is important to understand who has access to social prescribing, and why, to understand how it is being used, whether it improves health, and whether it might make existing inequalities in health better or worse. We will describe the characteristics of patients who receive a social prescription, the reasons for the prescription, and whether the prescription is accepted or declined by the patients. A first step to understanding the effectiveness of social prescribing involves the relationships between social prescribing and healthcare use and health outcomes. Once we have looked at the characteristics of those who are offered a social prescription, we will assess whether there are any changes in patientsâ medication prescription or more general healthcare use and health outcomes in those who have been offered social prescribing.
Technical SummaryThe aim of this study is to describe how social prescribing is used in England in terms of the patients who receive this, the geographical areas where social prescriptions are given and whether prescribing has changed over time. A cohort of people over 18 years who have received a social prescription after 1/1/2021 and have at least six months of data in CPRD Aurum before their social prescription will be included. The dataset will be linked to the patient level index of Multiple Deprivation Domain in order that any differences between levels of socioeconomic status and social prescribing can be highlighted.
Social prescribing is the primary exposure and while the focus is descriptive analyses, the primary outcomes are measures of healthcare usage in terms of numbers of pharmacological prescriptions, healthcare appointments and diagnoses received following the social prescription compared with the 6 months before. The people within the cohort will be described in terms of their demographics, pharmacological prescriptions and diagnoses. If there is a record suggesting that the social prescription has been refused, this will be reported. Comparisons will be made descriptively and using Poisson regression to determine if there is evidence for an effect of the social prescription in changing levels of healthcare uptake or prescription counts or new diagnoses being made. As well as comparing the impact of the social prescription on an individualâs healthcare use, comparisons will also be made with a group who have an NHS Health Review or housing consultation but who do not receive a social prescription. The impact of this work for public health is in giving an overview of the use of social prescribing in England and find areas where social prescribing is having an effect on use of healthcare resources. Any disparities by ethnicity or socioeconomic group will be described.
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Trends over time in the use of Advice and Guidance and variation by sociodemographics and type of health condition: repeated cross-sectional and cohort study — Claire Burton ...
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Trends over time in the use of Advice and Guidance and variation by sociodemographics and type of health condition: repeated cross-sectional and cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; CCG Pseudonyms; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-11
Organisations:
Claire Burton - Chief Investigator - Keele University
Kayleigh Mason - Corresponding Applicant - Keele University
Alice Faux-Nightingale - Collaborator - Keele University
Christian Mallen - Collaborator - Keele University
Clare Jinks - Collaborator - Keele University
James Bailey - Collaborator - Keele University
John Haines - Collaborator - Not from an Organisation
Kelvin Jordan - Collaborator - Keele University
Lorna Clarson - Collaborator - Keele University
Ram Bajpai - Collaborator - Keele University
Rosie Harrison - Collaborator - Keele University
Samantha Hider - Collaborator - Keele University
Toby Helliwell - Collaborator - Keele University
Victoria Welsh - Collaborator - Keele UniversityOutcomes:
Advice and Guidance requests
Direct referrals to specialtiesDescription: Lay Summary
When a GP needs a specialist clinicianâs input with the care of a patient, they may make a direct referral to that specialist. Another option is to request Advice and Guidance (A&G). A&G is an electronic way for a GP to ask a specialist a clinical question. The response from the specialist may be to advise sending the patient to see the specialist, to try a treatment, or to do a test. A&G was introduced to speed up access to a specialist opinion and cut waiting times for outpatient care. A&G became more important during the COVID-19 pandemic as it meant patients did not automatically need to travel to a hospital. The use of A&G is now encouraged to help the NHS recover from the pandemic. There are few studies though telling us whether A&G has a better or worse effect on patient care than the usual referral system.
As part of a larger programme of work aiming to study the impact of A&G on patients, healthcare workers and the healthcare system, this study will describe how A&G is being used in the NHS. We will use CPRD Aurum to find out how many patients have had A&G requests. We will describe the patterns of A&G use since 2015 and work out whether some patients (for example, older patients, patient with certain illnesses, or patients from particular ethnic or socioeconomic backgrounds) are more likely to have A&G rather than direct referral.
Technical SummaryAdvice and Guidance (A&G) allows a primary care clinician to seek expert advice from a specialist, usually in an electronic format. Increasingly, rather than making a direct (elective outpatient) referral, clinicians are being encouraged to use A&G to reduce compound pressures on the NHS. Whilst the use of A&G has been identified as a crucial part of managing NHS waiting lists, there is little evidence of its effectiveness in reducing these compound pressures and some clinicians are reluctant to use it. The potential longer-term risks of harm to patients, such as diagnostic delay, have not been considered.
Our programme of work aims to measure the impact of A&G on patients, clinicians, and the healthcare system in terms of quality of care, satisfaction with the process, and service utilisation. Using CPRD Aurum, Ethnicity Record, CCG pseudonyms and patient-level deprivation the objective of this component is to describe use of A&G by evaluating trends in its prevalence and incidence from January 2015, compared to direct referrals, and variation in its use by socio-demographic and clinical characteristics. Joinpoint and segmented regression will be used to explore the impact of COVID-19 and policy changes on frequency of A&G. Descriptive analysis will assess variation in use of A&G and percentage of A&G requests which end up as a referral by age, sex, geographic region, ethnicity, deprivation, and clinical specialty/nature of health condition.
The other components of this multistage mixed-methods programme are analysis of the impact of A&G on waiting times and outcomes using CPRD Aurum and linked data (protocol to be developed), alongside qualitative research which will explore the experience and perspectives of A&G from patients, clinicians, and commissioners. This will help us to work out whether A&G reduces waiting times and access to specialist care as planned, without making quality of patient care worse.
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Amyloidosis Clinical Coding Framework in UK Primary and Secondary Care: An Observational Study — Jil Billy Mamza ...
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Amyloidosis Clinical Coding Framework in UK Primary and Secondary Care: An Observational Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-19
Organisations:
Jil Billy Mamza - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Jil Billy Mamza - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Eleanor Axson - Collaborator - CPRD
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Holly Bennett - Collaborator - CPRD
Kathleen White - Collaborator - CPRD
Lisa Anderson - Collaborator - St George's University Hospitals NHS Foundation Trust
Mike Lonergan - Collaborator - CPRD
Rachael Williams - Collaborator - CPRD
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
The following will be measured at amyloidosis diagnosis:
⢠Concordance and discordance between primary care and secondary care clinical coding
⢠Descriptive summary of responses from the GP questionnaire
⢠Patient characteristics similarities and differences between CPRD and NAC datasets
⢠New potential sub-groups within the amyloidosis patient populationDescription: Lay Summary
Amyloidosis is a serious health condition that occurs when a protein called amyloid folds incorrectly and accumulates in different parts of the body. Currently treatment options are limited and mainly focus on symptom management, whereas an early diagnosis of the disease is highly important for effective intervention and improved patient care. Amyloidosis are diagnosed at both primary and secondary care settings, but different clinical codings are usually applied, resulting in discrepant diagnoses and many patients not captured early in their disease pathway. We aim to study how amyloidosis and its sub-types are coded in clinical practice between primary and secondary care and compare characteristics of each group of patients. We will also explore ways to more clearly define/predict amyloidosis sub-types, as well as developing new tools for diagnosis. Overall, the hope is that this study will help understand common coding practice and issues in clinical settings, which can lead to a higher case detection rate through novel techniques, early intervention opportunities and ultimately better care for amyloidosis patients.
Technical SummaryAmyloidosis, characterized by the accumulation of misfolded amyloid proteins, encompasses AL (Primary), AA (Secondary), and transthyretin (ATTR) amyloidosis. ATTR, a clinically diverse and fatal disease, arises from the aggregation of transthyretin (TTR) amyloid fibrils in various organs and tissues. The study seeks to elucidate the landscape of amyloidosis clinical coding in both primary and secondary care in the UK.
This observational study will encompass patients aged over 18 years at diagnosis, using a defined list of diagnosis codes (ICD-10, Read/SNOMET-CT, and product codes) in CPRD Aurum & GOLD data, linked with Hospital Episode Statistics admission data (HES APC), Office for National Statistics (ONS) Death Registration data, and patient-level and practice-level index of multiple deprivation (IMD) data.
The primary objectives involve delineating the agreement and disagreement between existing clinical coding frameworks, as well as comparing patient characteristics across datasets. A questionnaire aimed at healthcare professionals (HCPs) will be used to gather insights on specific diagnosis codes selected for amyloidosis, enabling an assessment of the perceived efficacy of coding practices and facilitating recommendations for amyloidosis coding in primary care. The results from the questionnaire will be linked back to patients' CPRD records to evaluate the concordance in coding practices.
Additional goals include contrasting patient characteristics between CPRD and National Amyloidosis Centre (NAC) datasets, and employing machine-learning techniques to derive amyloidosis subtypes. Concordance and discordance between primary and secondary care diagnoses will be calculated, with descriptive statistics presented for patient demographics and clinical characteristics, as needed. Results from the GP questionnaire will be summarized as proportions. For algorithm performance, a machine learning approach will be adopted, and the derived clusters will be summarized using descriptive statistics. The area under the receiver operating curve (AUROC) will be leveraged to predict case definitions at varying sensitivities and specificities.
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Changes in healthcare, diagnosis, and treatment of acute and chronic conditions during the COVID-19 pandemic — Daniel Prieto...
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Changes in healthcare, diagnosis, and treatment of acute and chronic conditions during the COVID-19 pandemic
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-03
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Kim López-Güell - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of OxfordOutcomes:
Primary Outcomes:
1.Diagnoses of acute care conditions: COVID-19, other infectious diseases (influenza, pneumonia, urinary tract infection, sexually transmitted diseases, HIV), traumatic injuries (any fracture, hip fracture), thromboembolic disease (deep vein thrombosis, pulmonary embolism), and cardiovascular diseases (thromboembolic events, ischaemic heart disease, cerebrovascular disease).
2.Diagnoses of chronic conditions: type 1 diabetes, type 2 diabetes, cancer, autoimmune diseases (rheumatoid arthritis, systemic lupus, celiac disease, inflammatory bowel disease, multiple sclerosis), hypertension, hypercholesterolemia, dementia, mental health conditions (depression, general anxiety disorder).
3.Diagnoses of post-COVID conditions: post-acute COVID-19 symptoms according to the WHO definition, post-acute COVID-19 cardiac and thromboembolic complications.
Secondary Outcomes:
4.Procedures for the diagnosis or management of the above diseases.
5.Medicines for the treatment of any of the above diseases.
6.Healthcare utilization: screening appointments, diagnostic tests, GP consultations
Description: Lay Summary
Waves of COVID-19 transmission during the pandemic were usually followed by lockdowns and other interventions. Both likely affected lifestyle and health choices. Additionally, focusing NHS resources on the care of COVID-19 patients probably led to a decrease in screening, diagnosis, and treatment of many common conditions.
The aim of this study is to examine the trends of diagnosis and treatment of acute and chronic diseases in primary care, as well as the rates of post-COVID related conditions over time during the pandemic. We also aim to understand how waves of COVID-19 and lockdowns impacted the uptake of medicines commonly used to treat common chronic conditions. We will replicate these analyses separately in similar data from other European countries, from North America, and from Asia, to assess the effect of COVID-19 management and public health policies on different health systems.
This study will lead to a better understanding of the impact of COVID-19 waves and related policies on the health system, and the assessment of the most affected populations may lead to improvements or developments of new health polices to diminish the impact of COVID-19 on these diseases.
Technical SummaryThe aim is to understand whether healthcare utilisation, incidence of different acute care and chronic conditions, as well as post-COVID related conditions, were affected by COVID-19 transmission and public health restrictions; and whether rates have subsequently normalised to pre-pandemic levels.
Study Design: Cohort Study
Population: All patients registered in CPRD GOLD between 01.01.2018 to the latest date of data capture with â¥1 year prior history will be eligible. Data mapped to the Observational Medical Outcomes Partnership Common Data Model (OMOP) will be used to enable replication across other international databases.
Variables: The following conditions will be considered:
1.Acute care conditions: COVID-19, infectious diseases other than COVID-19, traumatic injuries, and cardiovascular and thromboembolic disease.
2.Diagnoses of chronic conditions: diabetes, cancer, dementia, autoimmune diseases, hypertension, hypercholesterolemia, mental health conditions.
3.Diagnoses of post-COVID conditions: post-acute COVID-19 symptoms, post-acute COVID-19 cardiac and thromboembolic complications.
4.Procedures (diagnostic or therapeutic) for the above diseases
5.Medicines/treatments for the above diseases
Analyses:
We will estimate monthly and quarterly incidence rates of new diagnoses for 1-3, of procedures used (4), and of related treatments (5) from January 2018 until January 2024, overall and stratified by age and sex. Secondly, we will fit interrupted time series and ARIMA models to study the impact of COVID-19 waves and public health restrictions on all the study outcomes. These analyses will be replicated separately internationally using other European, North American, and Asian datasets to study the impact of different public health policies.
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Effectiveness of glucagon-like peptide 1 receptor agonists to prevent and treat obstructive sleep apnoea — Samy Suissa ...
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Effectiveness of glucagon-like peptide 1 receptor agonists to prevent and treat obstructive sleep apnoea
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-14
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Charles Khouri - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Sleep apnoea diagnosis or treatment.
Description: Lay Summary
Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder, as people with OSA repeatedly stop and start breathing while they sleep. OSA is a significant risk factor for a variety of cardiovascular diseases, the conditions that affect your heart and blood vessels. Moreover, OSA and type 2 diabetes (a condition that causes the level of glucose in the blood to become too high) frequently occur together that further increase the risk for cardiovascular disease. Obesity remains the main modifiable risk factor for OSA. New anti-diabetic drugs (glucagon-like peptide 1 receptor (GLP-1 RA) agonists) have been developed for type 2 diabetes, and have shown significant efficacy in reducing the risk of cardiovascular disease in patients with type 2 diabetes, as well as significantly reducing body weight. We therefore hypothesize that GLP-1 RAs might be efficient to prevent the development of OSA and its severity.
Technical Summary
This study will use the Clinical Practice Research Datalink to determine whether the use of GLP-1 RAs is associated with a reduced risk of developing OSA and discontinuing treatment for OSA (such as continuous positive airway pressure, a device that uses positive pressure to keep the airway open during sleep) compared with DPP4 inhibitors (another class of anti-diabetic drugs), in two cohorts of adult individuals between 2007 and 2023.
If confirmed, this study will help inform clinicians about the potential efficacy of GLP-1 RAs to prevent and treat OSA for patients in England and Wales.Obstructive sleep apnoea (OSA) affects nearly one billion middle-aged individuals worldwide, with a rising prevalence reflecting the increasing prevalence of overweight and obese people. OSA is a significant risk factor for a variety of cardiovascular diseases, including hypertension, coronary heart disease, stroke and arrhythmias. Furthermore, OSA and type 2 diabetes frequently occur together, and both are associated with adverse metabolic consequences that further increase the risk for cardiovascular disease.
Glucagon-like peptide 1 receptors agonists (GLP-1 RAs) were developed as glucose-lowering agents for type 2 diabetes by targeting the incretin pathway, and demonstrated meaningful weight loss in trials of patients with and without type 2 diabetes. Several small non-placebo-controlled studies have suggested a beneficial impact of GLP-1 RAs on OSA, and OSA has been found to be associated with elevated serum levels of the incretin hormones GLP-1 and GIP in patients without diabetes.
he primary objectives of this study will be to assess the effectiveness of GLP-1 RAs to prevent OSA and to improve OSA in patients treated by continuous positive airway pressure (defined as a treatment discontinuation), compared to DPP4 inhibitors use, in two cohorts of patients>18 years of age between 1 January 2007 and 31 December 2023.
We will use an active comparator new user cohort design using the CPRD Aurum Database. The outcomes will be first diagnosis of OSA in the first cohort and discontinuation of CPAP in the second cohort. Subjects exposed to GLP-1 RAs will be matched 1:1 to exposed subjects to DPP4 inhibitors based on time-dependent propensity scores.
The hazard ratios (HR) and corresponding 95% confidence intervals (CI) of the outcomes with GLP-1 RAs use versus DPP4 inhibitors will be estimated using Cox proportional hazards regression models.
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Feasibility of using Clinical Practice Research Datalink data to identify people with long term wounds who develop poor mental and psychological wellbeing outcomes — Crina Grosan ...
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Feasibility of using Clinical Practice Research Datalink data to identify people with long term wounds who develop poor mental and psychological wellbeing outcomes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-07
Organisations:
Crina Grosan - Chief Investigator - King's College London (KCL)
Victoria Clemett - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Edgar Mandeng Ma Linwa - Collaborator - King's College London (KCL)
Mariam Molokhia - Collaborator - King's College London (KCL)Outcomes:
Primary exposure(s): patients over 18 years old with a wound lasting longer than 4 weeks will be identified. This is based on the wound related read codes and exclusion criteria identified by Guest et al (2020). See information on study population.
Primary outcome(s): onset of poor psychological wellbeing categorised as any or a combination of the following: new diagnosis of mental health disorders, recording of non-pharmacological psychological therapies, recording of pharmacological psychological therapies and/or referral to mental health services. This outcome include codes for mental health care plan (https://www.opencodelists.org/codelist/nhsd-primary-care-domain -refsets/mhp_cod/20200812/#full-list), invitations for mental health review (https://www.opencodelists.org/codelist/nhsd-primary-care-domain-refsetsâ¦), depression and anxiety diagnosis and symptoms (https://www.opencodelists.org/codelist/ons/depression-and-anxiety-diagnâ¦), seen by wellbeing coaches (https://www.opencodelists.org/codelist/nhsd-primary-care-domain-refsetsâ¦) as well as the use of medications to manage psychological wellbeing and patient admission data using medical codes (SNOMED) and product codes based on the BNF code lists developed before by Dr Dregan.
Other variables of interest will include wound characteristics and symptoms, and index of multiple deprivation.
Description: Lay Summary
Long term wounds are a serious health problem worldwide, affecting a significant number of people. This not only harms people's health but also cost a lot of money. This affects about 7% of the UK population who have a wound that last more than 4 weeks.
Mental health issues, such as stress and depression, can affect how wounds heal. In fact, hard-to-heal wounds can have a big impact on a person's mental health, due to wound related symptoms such as pain and mobility, and time for the wound to heal. This creates a cycle where the wound affects mental health, and mental health affects wound healing.
We are interested whether data in the CRPD database captures information on (a) whether people with long term wounds have poor mental and psychological wellbeing outcomes and (b) the factors that are likely to influence whether people with long term wounds have poor mental and psychological wellbeing outcomes.
We would like to examine
(1) the proportion of people with hard to heal wounds who have poor mental health and psychological wellbeing captured by the CRPD database.
(2) Whether data in CRPD database could be used to determine people more at risk of poor mental health or psychological wellbeing outcomes.This information in this feasibility study will determine whether it is practical to use CRPD data to develop computer assisted learning (machine learning) from data to predict poor mental and psychological wellbeing outcomes in people with long term wounds.
Technical SummaryRationale: Risk prediction models could be used to estimate the likelihood of outcome development. This can improve risk assessment and personalise care. This project will determine the feasibility of the CRPD dataset in predicting poor mental health and psychological wellbeing outcomes in people with a chronic or hard to heal wound.
Background: In the UK 7% of the population have a wound that last more than four weeks (Guest et al., 2020). These may have a negative impact on emotional wellbeing and quality of life (Olsson, 2019). Poor psychological wellbeing, resulting from the wound and its associated symptoms, may lead to a decreased motivation to manage their wound and adhere to treatment impeding healing (Atkin et al, 2019). Machine learning could be used to predict risk of developing poor psychological wellbeing based on data collected from previous patients (Queen, 2019). This may enable early interventions to be targeted and care personalised.
Research questions:
â¢Is poor mental health or psychological wellbeing in people with chronic and hard to heal wounds captured on the CRPD database?
â¢Are variables affecting poor mental health or psychological wellbeing outcomes in people with hard to heal and chronic wounds captured on the CRPD database?Method:
â¢Patients over 18 years old who a chronic wound or surgical/trauma wound unhealed after four weeks will be exported from the CRPD database.
â¢These patients will be classified as those with and without poor mental health and phycological wellbeing.
â¢Variables of interest identified within our recent scoping review of factors thought to effect mental health and psychological wellbeing will be examined to determine whether these factors are captured
â¢We will determine whether a predictive model using machine learning algorithms could be built from this data. This will inform our future study.
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Feasibility study to assess outcomes in patients with symptoms of colorectal cancer and negative quantitative faecal immunochemical test — Jessica Watson ...
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Feasibility study to assess outcomes in patients with symptoms of colorectal cancer and negative quantitative faecal immunochemical test
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-14
Organisations:
Jessica Watson - Chief Investigator - University of Bristol
Lewis Buss - Corresponding Applicant - University of BristolOutcomes:
Quantitative faecal immunochemcial test results; recorded symptoms and signs in the CPRD Aurum Observation table that correspond with the NICE guidance on suspected colorectal cancer - namely, weight loss, abdominal pain, rectal bleeding, change in bowel habit and iron-deficiency anaemia.
Description: Lay Summary
Colorectal cancer is a common and important health problem in the UK, where national guidance recommends that people with possible symptoms of colorectal cancer are offered a test of their stool called a quantiative faecal immunochemical test (qFIT). qFIT detects small quantities of blood in the faeces that can indicate the presence of colorectal cancer and other important bowel disease. People with negative tests do not require any further investigation for colorectal cancer and are being looked after by their GP to establish another cause for their symptoms. Although there is good evidence from large studies that this is an appropriate strategy, there is a lack of real-world data on how best to investigate and treat people with ongoing symptoms but a negative qFIT result.
Technical Summary
In this faesibility study we aim to establish the quality of data around qFIT results in the CPRD dataset in order to plan a larger analysis of patient outcomes that have negative qFIT results.Colorectal cancer (CRC) is the fourth most common malignancy in the UK. Despite the national screening programme, most people with CRC will present to their GP with symptoms. Since publication of NICE guidance NG12, quantitative faecal immunochemical tests (qFIT) been progressively rolled out across UK primary care, as a rule out test for most patients with possible symptoms of CRC. This has meant that patients with symptoms of CRC and a negative qFITâ i.e. those who previously were referred for definitive testing â are now being held by primary care.
Our aim in a future study â i.e. if this feasibility study shows that adequate data is recorded in CPRD Aurum - is to estimate the real-world frequency of missed CRC with negative qFIT as well as non-CRC intrabdominal diagnoses such as other cancers, inflammatory bowel disease, and other significant bowel pathology. This feasibility study will have public health impact by determining whether CPRD is a suitable resource for future research on the real-world performance of qFIT â an issue that is important for primary care physicians and patients with symptoms of CRC.
This feasibility study is to establish whether sufficient information is coded within CPRD Aurum on qFIT tests in symptomatic patients. Specifically, whether the quantitative results are recorded and whether they can be distinguished from qFITs used for screening.
The population is all patients, irrespective of age or sex, in whom a qFIT test result is coded in CPRD Aurum between 01/01/2018 to 01/01/2024. For the feasibility study we will assess data quality and basic demographics only. Specifically, the proportion of patients with a recorded quantitative result versus a binary positive/negative; whether these can be distinguished from screening qFITs by the positive threshold (10 versus 100μgHb/g); and the age/sex distribution of these patients and their symptoms/signs (n, %)
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Initial uptake of Shingrix vaccine in England: a cohort study — Gayatri Amirthalingam ...
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Initial uptake of Shingrix vaccine in England: a cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-10
Organisations:
Gayatri Amirthalingam - Chief Investigator - UK Health Security Agency (UKHSA)
Jemma Walker - Corresponding Applicant - UK Health Security Agency (UKHSA)
Colin Campbell - Collaborator - UK Health Security Agency (UKHSA)
Colleen Chambers - Collaborator - UK Health Security Agency (UKHSA)
Julia Stowe - Collaborator - UK Health Security Agency (UKHSA)
Lisa Byrne - Collaborator - UK Health Security Agency (UKHSA)
Nick Andrews - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
Shringrix® vaccine uptake overall and cumulatively by month for the rollout cohort; and shingles vaccine uptake for the catch up cohort.
Description: Lay Summary
Around one in four adults will experience shingles in their lifetime. Shingles is a viral infection that causes a painful rash. Usually, the rash is on one side of the chest or belly. But it can also appear anywhere including the face. Shingles can also have other symptoms like headaches and feeling generally unwell. Shingles symptoms usually resolve within 4 weeks. But some people experience continuing pain and other serious complications. This ongoing, or more often intermittent, pain is called âpost-herpetic neuralgiaâ. One of the main reasons for giving a shingles vaccine is to prevent this lasting pain.
Shingrix® replaced Zostavax® in the routine vaccination schedule in September 2023. It is recommended for those aged 60-79, but rollout is over a period of years and has started with those aged 65 and 70. Zostvax® was previously offered to those aged 70-79, and these individuals remain eligible for Shingrix® (or Zostavax® while supplies remain) until their 80th birthday.
As a live vaccine Zostavax® was not recommended for those with weak immune systems, Shingrix has been recommended for these individuals aged 70-79 since September 2021.We want to report initial uptake of first dose of shingles vaccine in those eligible by age from September 2023 onwards.
Our aim is to assess whether the uptake is lower than planned for, and if there would capacity to expand the rollout faster than anticipated to other ages within the recommended band. This would give more people the opportunity to be vaccinated against shingles.
Technical SummaryOur study aims to describe the coverage of Shingrix® vaccine uptake in eligible adults in England. We will conduct a cohort study of Shingrix®-eligible adults (from 01-Sept-2023 to latest data available) of those
- aged 65 and 70 â rollout cohort
- those aged 71-79 to monitor catch up uptake- catch up cohortIndividuals will enter the study from the latest of: study start (01-Sept-2023), the year they become eligible, and one year after current practice registration. We will exclude any individual in the rollout cohort (age 65 and 70) who has received any shingles vaccine prior to 1st September 2023. (Shingrix® or Zostavax®)
Individuals will be excluded from the catch- up cohort (age 71-79) if they have received any shingles vaccine prior to age 70 eligibility (as part of historical vaccine campaigns).
Individuals will be eligible for inclusion until the earliest of end of study (date latest data available until), age 66 or 71 for rollout cohort, 80 for catch up cohort, death, practice no longer contributing to CPRD, or end of registration.We will describe the number and proportion vaccinated of eligible adults in each cohort (rollout and catch up) overall and stratified by age, sex, region, ethnicity and index of multiple deprivation (IMD).
This analysis will be presented to JCVI to inform vaccination policy. If we find that uptake of vaccination is lower than planned for then there may be the capacity to expand the rollout faster than anticipated to other ages within the recommended band of 60-79 year olds. This would give more people the opportunity to be vaccinated against shingles- lowering both the incidence and severity of shingles in older people.
This analysis will be a baseline and will be repeated yearly for surveillance purposes.
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Impact of label changes on fluoroquinolone-containing medicinal products for systemic use in the European Union, taking into account possible unintended impact and choices for the study population. — Helga Gardarsdottir ...
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Impact of label changes on fluoroquinolone-containing medicinal products for systemic use in the European Union, taking into account possible unintended impact and choices for the study population.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-06-17
Organisations:
Helga Gardarsdottir - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Satu Johanna Siiskonen - Collaborator - Utrecht University
Tomas Lasys - Collaborator - Utrecht University
Yared Santa Ana Tellez - Collaborator - Utrecht UniversityOutcomes:
To assess the impact of regulatory intervention, we will assess drug utilization patterns and trends of several health outcomes associated with the use of fluoroquinolones or alternative antibiotics. The following outcomes will be examined:
1. Drug use (incident and prevalent use rates of antibiotics)
2. Tendinitis
3. Tendon rupture;
4. Aortic aneurysm;
5. Aortic dissection;
6. Clostridium difficile infections;
7. Allergic reactions related to antibiotic use;
8. Subsequent hospitalisations for infectious diseases.Health outcome trends will be assessed if health outcomes will be recorded in the medical records in the period within the antibiotic treatment episode or within 30 days after the end of that treatment episode.
Description: Lay Summary
Quinolones and fluoroquinolones are a type of antibiotics used to treat various infections. Although these drug work well, their use has also been linked to rare, but serious side effects, such as inflammations and ruptures of tendons or weakening of the wall of large arteries. Because of these side effects, the European Medicines Agency (EMA) issued new regulatory interventions targeting these drugs in 2018 and again in 2020. The goal of these interventions was to increase awareness of these side effects among doctors and to improve prescribing practices of antibiotics. Interventions included the sending of letters to doctors to warn against these side effects and changing the range of infections for with they drugs could be prescribed.The primary aim of this study is to study whether these interventions have resulted in different numbers of patients getting prescribed (fluoro)quinolones before and after these interventions and if the number of these serious side effects has decreased since they were put in place.
Technical SummaryA population-based longitudinal observational study will be conducted using data from the CPRD database to examine antibiotic prescription patterns and trends of health outcomes related to antibiotic use. The study population will consist of all patients registered with the CPRD database during the study period who will be followed up until death, end of follow-up or end of registration. The population of interest will be selected based on recorded antibiotic prescription or recorded diagnosis of bacterial infection. The selected health ourcomes will be selected from both CPRD GOLD and Hospital Episode Statistics (HES) admission data. The outcomes of interest will be changes in prescribing patterns of fluoroquinolones and other systemic antibiotics, and changes in trends of selected health outcomes related to fluoroquinolone use (aortic dissection, aortic aneurysm, tendinitis, tendon rupure) or other antibiotics (hospitalization due to infection, allergy to antibiotics, clostridium difficile infection). We will use interrupted time series regression to determine whether statistically significant changes in prescribing or health ourcomes were associated with regulatory interventions. The outcomes will be assessed based on patients risk profile (medical history of aortic dissection, aortic aneurysm, tendinitis, tendon rupure; concomitant use of glucocorticoids or statins). The primary goal of the study is to assess the impact of risk minimisation measures (RMMs) targeting fluoroquinolone-containing medicinal products, taking into account the possible unintended effects of RMMs.
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ID-416: Evaluation of the accessibility of the providing assessment and treatment for children at home (PATCH) service across NW London
— Imperial College London...
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ID-416: Evaluation of the accessibility of the providing assessment and treatment for children at home (PATCH) service across NW London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: PATCH.
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ID-413: Evaluation of new approaches and investments in services to support diabetes care in North West London — Richford Gate Medical Practice...
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ID-413: Evaluation of new approaches and investments in services to support diabetes care in North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-24
Opt Outs: no information provided./p>
Organisations: Richford Gate Medical Practice
Description: Diabetes.
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ID-412: Inequalities in Mental Healthcare Services: A mixed-method approach identifying actionable measures to mintor inequalities and inform improvement efforts — Imperial College London...
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ID-412: Inequalities in Mental Healthcare Services: A mixed-method approach identifying actionable measures to mintor inequalities and inform improvement efforts
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental Health.
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ID-414: Veterans Physical Health Needs Assessment — Imperial College London...
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ID-414: Veterans Physical Health Needs Assessment
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Veterans.
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ID-415: Establishing Population Health Management Clinic (PHMC) in Surgical Pre-Assessment Unit in WMUH — Hounslow and Richmond Community Healthcare NHS Trust...
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ID-415: Establishing Population Health Management Clinic (PHMC) in Surgical Pre-Assessment Unit in WMUH
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-24
Opt Outs: no information provided./p>
Organisations: Hounslow and Richmond Community Healthcare NHS Trust
Description: PHMC.
Source
2024 - 05
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A study of the association between diabetes and fibrotic multimorbidity — Jennifer Quint ...
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A study of the association between diabetes and fibrotic multimorbidity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-07
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Georgie Massen - Corresponding Applicant - Imperial College London
Gisli Jenkins - Collaborator - Imperial College London
Iain Stewart - Collaborator - Imperial College London
Louise Wain - Collaborator - University of Leicester
Sarah Cook - Collaborator - Imperial College LondonOutcomes:
Percentage of people with fibrotic conditions and fibrotic multimorbidity, subgrouped by diabetes management and related disease complications (e.g. retinopathy)
Association between diabetes management and diagnosis of fibrotic conditions (subgrouped).Description: Lay Summary
Diabetes is a condition where a person cannot control their blood sugar levels. There are two main types of diabetes. Type 1 diabetes is when a person cannot produce insulin which is needed to control blood sugar it can develop at any age but is often diagnosed when people are young. People with type 1 diabetes must inject themselves with insulin to control their blood sugar levels. In contrast, Type 2 diabetics are insulin resistant, when insulin does not work as well. People with type 2 diabetes can be managed with a combination of lifestyle (by the foods they eat), non-insulin medications and insulin. In both types of diabetes, if blood sugar levels are not controlled, people with diabetes may get damage to their eyes, kidneys, and nerves.
Some diseases such as diabetes can cause organ scarring, damaging the affected organ, and decreasing its ability to function, eventually leading to organ failure. These diseases can be referred to as being fibrotic. We will investigate if more people with diabetes and damaged eyes/ kidneys/ nerves have other fibrotic conditions, compared with people with diabetes without damaged eyes/ kidneys/ nerves. We will also look to see if less people with diabetes who are on certain medication get fibrotic conditions compared with people on other medication for diabetes and those who are prescribed insulin, as a marker for more advanced diabetes. This will benefit public health as it will inform us if there are other conditions associated with diabetes that are also fibrotic.
Technical SummaryFibrosis can affect any organ; fibrotic conditions are characterised by excessive, uncontrolled deposition of extracellular matrix in the effected site, this in turn alters the tissueâs extracellular environment, leading to organ failure. Despite fibrosis leading to eventual organ death, there is still a large gap in the understanding of fibrotic diseasesâ aetiologies and pathways. Fibrotic multi-morbidity is defined as the simultaneous occurrence of more than one fibrotic condition in a patient. Previous work using a Delphi methodology determined conditions which were always/ sometimes fibrotic using clinical consensus. As a result of this work diabetes mellitus was defined as being sometimes fibrotic.
In the UK, Diabetes mellitus (DM) affects a substantial proportion of the population, with over 4.3 million people affected. Around 90% of DM cases in the UK are of type 2 diabetes, we will explore both type 1 and type 2 diabetes.
We will explore complications associated with poor diabetes management/ control (diabetic retinopathy, diabetic nephropathy, and diabetic neuropathy and in the case of type 2 diabetics alone we will also apply NICE treatment guidelines to classify the medication stage). We will then look to see based upon the people with and without âpoor diabetes management/controlâ the proportion of people with fibrotic conditions differs, as well as the average number of fibrotic conditions.
We will use linked CPRD Aurum with HES APC, ONS data as well as IMD data. CPRD Aurum data will be used to define the complications and prescription data will also be analysed. CPRD Aurum, HES APC and ONS data will be used to define fibrotic conditions. Our primary outcome is diagnosis of a fibrotic condition. We will use Logistic regression models.
This work will look to provide further insight into whether diabetes management is associated with fibrotic conditions.
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Health and Labor Market Impacts of Hormone Replacement Therapy: A Descriptive Retrospective Analysis of Hormone Replacement Therapy Prescriptions Using UK Primary Care Data and Supplementary Labour Force Survey and Understanding Society Survey Data — Rhys Thomas ...
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Health and Labor Market Impacts of Hormone Replacement Therapy: A Descriptive Retrospective Analysis of Hormone Replacement Therapy Prescriptions Using UK Primary Care Data and Supplementary Labour Force Survey and Understanding Society Survey Data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-15
Organisations:
Rhys Thomas - Chief Investigator - University of Oxford
Rhys Thomas - Corresponding Applicant - University of Oxford
Brendon McConnell - Collaborator - City University London
Emmanouil Mentzakis - Collaborator - City University LondonOutcomes:
First stage outcomes: The outcome of interest in the first-stage analysis (using the CPRD) are whether patientsâ were prescribed HRT medication and the type of HRT medication prescribed. Outcomes of interest in our analysis are whether patientsâ were prescribed HRT medication and the type of HRT medication prescribed. We will consider any âBNF code 6.4.1.1: Oestrogens and Hormone Replacement Therapyâ prescription to be HRT prescriptions. We will further analyse progestogen (dydrogesterone, medroxyprogesterone, norethisterone, levonorgestrel and micronised progesterone) and Oestrogen (estradiol, estrone and estriol) prescriptions separately. In the appendix of this protocol, we present the list of medications and the corresponding product codes that we will use in our analysis.
Second-stage outcomes: The estimates from the first stage will then be used to estimate the impact of HRT on employment status (including working hours, whether part-time or full-time, and reason for not currently working), whether had time off due to sickness (including period of sickness, and type of sickness) from the Labour Force Survey, and subjective wellbeing and self-assessed general health from Understanding Society. Further, we will use Understanding Society to analyse the impact of HRT on marital stability through changes in marital status.
Description: Lay Summary
Hormone replacement therapy use has received significant attention in recent years, even so, hormone replacement therapy use among women of menopausal age is still relatively low â approximately 15% as of February 2023 according to the Department of Health and Social Care. A lack of awareness of the benefits of hormone replacement therapy use in alleviating symptoms, and the misunderstood risks associated, may be a contributor to the limited use. In May 2021, Davina McCall released "Sex, Myths and the Menopause", a documentary with the aim of âbusting midlife taboos from sex to hormone treatmentâ. In the following months female sex hormone prescriptions increased dramatically.
We aim to analyse the effect hormone replacement therapy prescriptions have on health and labour market outcomes of individuals. Our study design uses the timing of the Davina McCall documentary in May 2021, and the resulting increase in hormone replacement therapy prescriptions, to assess its impacts on womenâs health and labour outcomes. We hypothesis that hormone replacement therapy use has major implications for womenâs overall health, which could lead to beneficial impacts on womenâs work outcomes. Our project will seek to assess whether hormone replacement therapy prescriptions do indeed benefit women in this way.
Technical SummaryOur analysis will use a two-sample two-stage least squares (TS2SLS) methodology to estimate the impact of hormone replacement therapy (HRT) use on health and labour market outcomes. We will use the timing of Davina McCallâs documentary as an instrument for HRT prescriptions, estimating the first stage using a difference-in-differences approach, CPRD data, and women not of menopausal age as controls. Then, we will use the estimates from this first stage and survey data (Labour Force Survey or Understanding Society) to analyse the impact on womenâs health and labour outcomes. The use of the TS2SLS and survey data allows us to access a wider range of outcomes than is available in the CPRD data. The outcomes of interest are: employment status (including working hours, and reason for not currently working), whether had time off due to sickness (including period of sickness) from the Labour Force Survey, and subjective wellbeing, self-assessed general health, and martial stability from Understanding Society. Finally, we will validate our methodological approach design in two ways: using the outcomes of men as a placebo in a reduced form using Labour Force Survey and Understanding Society data, and estimate the effect of the documentary release on a drug we would not expect to be impacted by the documentary.
The Government Equalities Office estimate that in 2017 13 million women are experience the menopause each year and therefore studies assessing the potential benefits of medication which alleviate the symptoms are necessary. This study will contribute evidence of the impacts HRT medication has on women experiencing the menopause. These results will allow policy makers to make informed decisions regarding prioritisation, availability, and accessibility of medications, ultimately aiming to improve the quality of life for women navigating the challenges of menopause.
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Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment: Investigation of Any Safety Events and Events of Special Interest — CRISTINA REBORDOSA GARCIA ...
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Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment: Investigation of Any Safety Events and Events of Special Interest
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-08
Organisations:
CRISTINA REBORDOSA GARCIA - Chief Investigator - RTI Health Solutions ( USA )
Becky MacKay - Corresponding Applicant - RTI Health Solutions ( USA )
Andrea Margulis - Collaborator - RTI Health Solutions ( USA )
Anne-Elie Carsin - Collaborator - RTI Health Solutions ( USA )
David Martinez - Collaborator - RTI Health Solutions ( USA )
Estel Plana Hortoneda - Collaborator - RTI Health Solutions ( USA )
Jaume Aguado - Collaborator - RTI Health Solutions ( USA )
JOSEP RAMON MARSAL MORA - Collaborator - RTI Health Solutions ( USA )
Katica Boric - Collaborator - RTI Health Solutions ( USA )
Maria Foraster Pulido - Collaborator - RTI Health Solutions ( USA )
Nuria Saigi - Collaborator - RTI Health Solutions ( USA )
Raquel Garcia Esteban - Collaborator - RTI Health Solutions ( USA )
Sandra Bertran - Collaborator - RTI Health Solutions ( USA )
Susana Perez-Gutthann - Collaborator - RTI Health Solutions ( USA )
Xabier Garcia de Albeniz - Collaborator - RTI Health Solutions ( USA )Outcomes:
Primary outcomes:
Any safety event in the hepatic impairment population; Hepatic transaminase elevations, clinical hepatitis, or jaundice as safety outcomes of special interest in the hepatic impairment population; Severe vomiting, nausea, diarrhoea, or abdominal pain as safety outcomes of special interest in the hepatic impairment population; Dysgeusia as safety outcome of special interest in the hepatic impairment population; Headache as safety outcome of special interest in the hepatic impairment population; Hypertension as safety outcome of special interest in the hepatic impairment population; Anaphylactic reactions as safety outcome of special interest in the hepatic impairment population.
Any safety event in the renal impairment population; Severe vomiting, nausea, diarrhoea, or abdominal pain as safety outcomes of special interest in the renal impairment population; Dysgeusia as safety outcome of special interest in the renal impairment population; Headache as safety outcome of special interest in the renal impairment population; Hypertension as safety outcome of special interest in the renal impairment population; Anaphylactic reactions as safety outcome of special interest in the renal impairment population.
Secondary outcomes:
Hepatic transaminase elevations, clinical hepatitis, or jaundice resulting in hospitalization or emergency department visits in the hepatic impairment population; Severe vomiting, nausea, diarrhoea, or abdominal pain resulting in hospitalization or emergency department visits in the hepatic impairment population; Dysgeusia resulting in hospitalization or emergency department visits in the hepatic impairment population; Headache resulting in hospitalization or emergency department visits in the hepatic impairment population; Hypertension resulting in hospitalization or emergency department visits in the hepatic impairment population; Anaphylactic reactions resulting in hospitalization or emergency department visits in the hepatic impairment population.
Severe vomiting, nausea, diarrhoea, or abdominal pain resulting in hospitalization or emergency department visits in the renal impairment population; Dysgeusia resulting in hospitalization or emergency department visits in the renal impairment population; Headache resulting in hospitalization or emergency department visits in the renal impairment population; Hypertension resulting in hospitalization or emergency department visits in the renal impairment population; Anaphylactic reactions resulting in hospitalization or emergency department visits in the renal impairment population.
Description: Lay Summary
Paxlovid is an antiviral used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the COVID-19 disease becoming severe. The safety of Paxlovid in patients with moderate or severe kidney or liver damage is unknown.
This study aims to explore the safety of Paxlovid in patients with COVID-19 and moderate or severe liver or kidney damage. For both populations, the primary objectives are to assess the safety of Paxlovid compared to two comparator groups; and to assess side effects resulting from drug overexposure due to impaired liver/kidney function and regarding severity and frequency compared with the comparator groups. The comparator groups are the population prescribed molnupiravir (or comparable COVID-19 antivirals), and the patients with COVID-19 who had not received Paxlovid, molnupiravir or other comparable antivirals. The secondary objective is to assess all safety events included in the primary objective that require hospitalisation or emergency department visits.
The study will use existing data from the UK (CPRD), France and Spain. Analyses will follow a common study protocol and statistical analysis plan. Results from each data source will be combined using statistical techniques. The findings of this study will inform about the safety of Paxlovid in patients with COVID-19 and moderate/severe kidney or liver damage.
This study is a commitment to the European Medicines Agency and is registered in a repository for regulatory and other studies (EU PAS Register reference number: EUPAS50123).
Technical SummaryPaxlovid is an antiviral used to treat COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19. The safety of Paxlovid in patients with moderate or severe kidney or liver damage is unknown.
The research questions are: what is the safety profile of Paxlovid in patients with COVID-19 and moderate or severe hepatic impairment, and what is the safety profile of Paxlovid in patients with COVID-19 and moderate or severe renal impairment? For both populations, the primary objectives are to assess the safety of Paxlovid compared to patients prescribed molnupiravir (or other comparable COVID-19 medications, where available), and to unexposed patients with COVID-19. The primary outcomes are any safety events and events of special interest (severe vomiting, nausea, diarrhoea, or abdominal pain; headache, dysgeusia, hypertension, and anaphylactic reactions for both populations, and hepatic transaminase elevations, clinical hepatitis, and jaundice for the hepatic impairment population). The secondary objective is to assess all safety events included in the primary objective that require hospitalisation or emergency department visits. The study will employ a cohort design and use existing data sources in the UK (CPRD), France and Spain. The feasibility component will provide counts and characteristics of the target population.
Analyses will follow a common protocol and statistical analysis plan, and will use centralized programming. Analyses will include descriptive and comparative components, including propensity score models, and bootstrapping to calculate the confidence intervals. Data-source-specific results will be combined via meta-analysis.
This study is a commitment to the European Medicines Agency. This protocol is registered in the EU PAS Register (EUPAS50117).
This is the first out of two data extractions for this study.
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Incidence and Prevalence of Ectopic Pregnancy — Neil Cockburn ...
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Incidence and Prevalence of Ectopic Pregnancy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-15
Organisations:
Neil Cockburn - Chief Investigator - University of Birmingham
Neil Cockburn - Corresponding Applicant - University of Birmingham
Arturo Gonzalez-Izquierdo - Collaborator - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
Katherine Phillips - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Rowland Seymour - Collaborator - University of Birmingham
William Parry-Smith - Collaborator - Keele UniversityOutcomes:
Ruptured ectopic pregnancy;
Ectopic pregnancy;Description: Lay Summary
An Ectopic Pregnancy happens when a pregnancy starts growing outside of the womb. This usually happens in the fallopian tubes, which are tubes that carry a new pregnancy to the womb. These pregnancies will not usually survive longer than 8 weeks, as the body cannot support the growing baby outside of the womb. Ectopic pregnancies need to be treated to end the pregnancy before they cause complications like a ruptured ectopic pregnancy, which is where the fallopian tube splits open and can cause life-threatening bleeding. Ectopic pregnancies are the leading cause of death in early pregnancy, and can cause fertility issues.
Technical Summary
We have seen trends in national data which suggest that the rate at which ectopic pregnancies happen is changing, especially across different age groups, and may be rising in young women. The reason for this is not clear, and so this study is trying to confirm if this change in the rate of ectopic pregnancy is happening, and explain this change using what is already known about ectopic pregnancies. If we confirm a rise in ectopic pregnancies, this will affect the care offered during early pregnancy. If we cannot explain this change in terms of what is already known about ectopic pregnancy, it may mean there is a new cause of ectopic pregnancy that needs further research to identify and treat the cause. This will enable health services to prevent ectopic pregnancies, and the risks that ectopic pregnancies pose to life and to fertility.The incidence of ectopic pregnancy may be rising in women aged under 20 and population epidemiological risk factors do not explain this trend. Confirming this trend is challenging because many pregnancies that could have been ectopic (typically up to 8 weeks, after which ectopics are rarely viable) are not recorded, varying according to outcome such as miscarriage, and the pregnancies are missing at random. We will calculate a denominator of conceptions at risk using the CPRD pregnancy register and adjust the sample using prior estimates of the probability of miscarriage, termination, stillbirth and livebirth. Ascertainment of ectopic pregnancy, ruptured ectopic pregnancy, miscarriage, termination, stillbirth and livebirth will be supplemented by linkage with CPRD Aurum and HES APC diagnostic and procedure codes. Incidence will be calculated per pregnancy, and incidence and prevalence per included participant. Subgroup analyses will be calculated by age, ethnicity, and deprivation, using individual- and practice-level Index of Multiple Deprivation derived from linked area data to identify health inequalities of ectopic pregnancies. Outputs and covariates will be extracted from the linked primary and secondary care records per mother and per pregnancy. We will also fit a logistic regression model adjusting for known causes and risk factors for ectopic pregnancy, drawn from CPRD Aurum data, exploring if these covariates can explain residual risks in subgroups, to support future hypothesis generation about causes of changing trends. This study is important because no data on ectopic pregnancy has been published in the UK since 2008 and no data on ethnicity or other dimensions of deprivation (inequality) in ectopic pregnancies have ever been published to our knowledge.
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Association between hypertensive disorders of pregnancy and subsequent development of arrhythmias: A retrospective cohort study — Nicola Adderley ...
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Association between hypertensive disorders of pregnancy and subsequent development of arrhythmias: A retrospective cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-31
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Nicola Adderley - Corresponding Applicant - University of Birmingham
Kelvin Okoth - Collaborator - University of Birmingham
Kshitij Bhardwaj - Collaborator - University of BirminghamOutcomes:
Primary outcome: Development of arrhythmias.
Secondary outcomes: Specific types of arrhythmias, including: atrial fibrillation or flutter, premature beats, right bundle branch block, atrial tachycardia, atrioventricular block, paroxysmal tachycardia, ventricular fibrillation, and bradycardias.Description: Lay Summary
Hypertensive disorders of pregnancy (HDPs) include gestational hypertension (raised blood pressure after 20 weeks of pregnancy) and pre-eclampsia (raised blood pressure after 20 weeks of pregnancy and kidney malfunction or involvement of other organs like the liver and brain). According to the National Health Service (NHS), HDPs affect around one in ten pregnancies in the UK.
The link between HDP and risk of long-term heart and blood vessel disease (cardiovascular disease) is well established. However, research exploring the association between HDPs and cardiac arrhythmias (abnormal heart rhythm) is limited. Previous studies have shown mixed results regarding the association between HDPs and development of arrhythmias later in life, with some reporting increased risk while others found no significant link. Limitations such as short follow-up duration and potential underreporting of milder cases of arrhythmias were noted.
We will explore whether HDPs are linked to cardiac arrhythmias, including specific arrhythmias like atrial fibrillation. We will also look at different types of HDPs and whether they affect the risk of arrhythmias. Additionally, we will check whether age plays a role in this relationship by looking at different age groups of women. We use primary care (GP) data and will address some of the limitations of earlier research, such as having a longer follow-up period to explore the association.
If we find that HDPs are linked to arrhythmias, these findings could help in implementing better health care and monitoring, which may lead to fewer heart problems for women who had high blood pressure during pregnancy.
Technical SummaryAim
To examine the potential association of hypertensive disorders of pregnancy (HDPs) with the later development of cardiac arrhythmias.Objectives
Primary: Investigate the relationship between HDPs (including gestational hypertension, pre-eclampsia, and eclampsia) and the subsequent development of any arrhythmias.Secondary:
⢠Investigate the relationship between HDPs and different types of arrhythmias (including atrial fibrillation or flutter, premature beats, right bundle branch block, atrial tachycardia, atrioventricular block, paroxysmal tachycardia, ventricular arrhythmias, and bradycardias).
⢠Subgroup analysis to examine the association with specific HDPs.
⢠Stratified analysis by age.Study population of interest
Reproductive age females (aged 18 to 50 at baseline).Primary exposure
Hypertensive disorders of PregnancyOutcomes
Cardiac arrhythmias.Data source
CPRD Aurum.Study design
Retrospective matched cohort study. Exposed and unexposed women will be matched by age (±1 year), delivery date (±1 year) and geographical region in a ratio of 1:2.Methods
Cox Proportional Hazards Regression analysis will be used to calculate the crude and adjusted hazard ratios (HR) for development of arrhythmias in the exposed group compared to the unexposed group, with corresponding 95% confidence intervals. In multivariable analysis we will adjust for anthropometric and sociodemographic characteristics (such as BMI, socio-economic status, age), lifestyle factors (current smoking status, excess alcohol consumption), comorbidities associated with cardiac arrhythmias (including hypertension, type 1 and type 2 diabetes, thyroid disorders, chronic obstructive pulmonary disease, obstructive sleep apnoea), depression and anxiety. The proportional hazards assumption will be checked using log-log plots and the Schoenfeld residuals test.Intended public health benefit
This will be the first large-scale cohort study in the UK examining the association between HDPs and arrhythmias using primary care data. The findings will add to the existing evidence and inform clinical guidance for women with a history of HDPs, potentially facilitating early diagnosis and improving the overall prognosis of these women.
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Evaluating the risks and benefits of renin-angiotensin system inhibitor treatment in chronic kidney disease using prediction under intervention models — Ruth Keogh ...
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Evaluating the risks and benefits of renin-angiotensin system inhibitor treatment in chronic kidney disease using prediction under intervention models
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-24
Organisations:
Ruth Keogh - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Katy Morgan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Edouard Fu - Collaborator - Leiden University Medical Center
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Juan Jesus Carrero - Collaborator - Karolinska Institute Sweden
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nan van Geloven - Collaborator - Leiden University Medical Center
Paris Baptiste - Collaborator - Queen Mary University of London
Patrick Bidulka - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcome: All-cause mortality
Secondary outcomes: major adverse cardiovascular events (MACE) defined as a composite of CV death, myocardial infarction (MI), stroke, hospitalisation for congestive heart failure; MACE defined as all-cause mortality, hospitalisation due to MI, hospitalisation due to stroke; kidney failure with replacement therapy (KFRT); a composite of KFRT and eGFR<15ml/min/1.73m2; cardiovascular (CV) mortalityDescription: Lay Summary
People with advanced chronic kidney disease (CKD) are at risk of negative outcomes including death, heart attack, stroke, kidney transplant and dialysis. Renin-angiotensin system inhibitors (RASi) are a family of drugs used in the treatment of advanced CKD to try to delay disease progression. Recent studies suggest that use of RASi may be linked to needing kidney transplant and/or dialysis and that stopping RASi may delay this. However, stopping RASi may also increase the risk of having a heart attack or stroke. Deciding whether and when to stop RASi is an issue frequently faced by patients and their doctors.
Ideally, to help make this decision, we would compare what would happen if a particular person continued to take RASi with what would happen if they did not. In practice, we cannot observe this. However, we can use statistical models based on large observational datasets like CPRD to build a picture of what might happen to patients with particular characteristics, such as how advanced their disease is, under different treatment choices. We can use these models to make predictions of a personâs chances of experiencing negative outcomes if they continued to take RASi, or if they stopped taking RASi. Exactly how to build these prediction models, and how to assess whether they perform well, is still an open question. This project will help to develop these statistical methods further and provide evidence on how continuing or stopping RASi treatment affects the chances of people with advanced CKD experiencing negative outcomes.
Technical SummaryThis project focuses on statistical methods for estimating causal effects of treatments using electronic health records (EHR) data, with applications in advanced chronic kidney disease (CKD). Renin-angiotensin system inhibitors (RASi) are a cornerstone treatment for patients with advanced CKD and are used with the aim of delaying disease progression. However, recent studies have suggested RASi treatment may be associated with accelerated kidney failure with replacement therapy (KFRT) and that discontinuing may improve estimated glomerular filtration rate and delay KFRT. Discontinuation may also increase risk of major adverse cardiovascular events (MACE). Deciding whether and when to stop RASi in patients with advanced CKD is a frequent issue in clinical practice. We will use a longitudinal cohort of adults with stage 4 CKD, to investigate the causal effect of stopping versus continuing RASi treatment, both at population average level and given a set of individual characteristics. Our primary outcome will be all-cause mortality, with secondary outcomes including MACE and KFRT, using linked ONS death registration data and admitted patient care HES data.
In EHR many factors, including features that vary over time, will confound the relationship between longitudinal treatment status and the outcome of interest. Specialist statistical methods have been developed for making causal inferences from observational data in the presence of complex confounding and treatment switching. Most methods focus on population average treatment effects, but there is increasing interest in methods for estimating individual-level expected outcomes under different treatment choices, which we refer to as âprediction under interventionsâ. However, practical applications of methods for developing and validating models for prediction under interventions are lacking.
Methods considered will include marginal structural Cox models, g-formula, and targeted maximum likelihood estimation. The methods will be compared in terms of their assumptions and feasibility. The target trial emulation framework will be used throughout.
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Estimating diagnosis incidence and age at diagnosis for growth-affecting conditions in UK children. — Helen Storr ...
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Estimating diagnosis incidence and age at diagnosis for growth-affecting conditions in UK children.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-24
Organisations:
Helen Storr - Chief Investigator - Barts and the London Queen Mary's School of Medicine and Dentistry
Joanna Orr - Corresponding Applicant - Queen Mary University of London
Andrew Prendergast - Collaborator - Queen Mary University of LondonOutcomes:
Primary analysis:
- Number of new yearly diagnoses for the following target conditions:
a) Growth Hormone Deficiency
b) Turner Syndrome
c) Primary hypothyroidism
d) Crohnâs Disease
e) Coeliac Disease
f) Skeletal dysplasia
g) Noonan Syndrome- Average age at diagnosis for each target condition
Secondary analysis:
Outcomes for secondary analysis are the same as for the primary analyses. Secondary analyses used covariates to assess differences in these outcomes by IMD, ethnicity, sex and pre-post pandemic.
- Number of new yearly diagnoses for the target conditions.
- Average age at diagnosis for each target condition
Description: Lay Summary
Height in childhood can be negatively affected by various health conditions. Many of these health conditions are relatively rare and the first indication of a problem is the childâs slowed growth. Poor growth can also be a sign of more common problems, such as difficulties absorbing nutrients. The options for treatment and results of these treatments are better when children are diagnosed at a younger age. Although in the UK children are measured at least twice between the ages of 2 and 5 years, these measurements are not currently formally used to find children with conditions that could affect their growth.
As part of a larger project, we are proposing to look at how many children are diagnosed with seven growth-affecting conditions each year in England, as well as the average age at diagnosis, using Clinical Practice Research Datalink (CPRD) data. This will help us understand if the way we check healthy childrenâs growth can be improved, by comparing the number of conditions diagnosed and the age at diagnosis with other countries with formal screening programmes. We will also look at the impact of the Covid-19 pandemic by comparing the number of diagnoses and age at diagnosis before and after the pandemic.
Technical Summary
We need to know how many children are normally diagnosed with these conditions and at what ages they are diagnosed to be able to see if a new way of checking children helps to increase diagnoses and lower the age at diagnosis.Our overarching objective is to obtain evidence of the effectiveness of current practice for the identification of growth disorders in the UK. We will do this by estimating the national yearly incidence of growth disorder diagnoses for seven target conditions, as well as estimating the average age at which these diagnoses are given. The population of interest includes patients with a new diagnosis of any of the seven specified growth disorders.
We will use data from the Aurum and Gold datasets to obtain all available diagnoses. All new individual diagnoses in children aged <18 year for the following growth disorders will be counted in the target years (2017-2022):
a) Growth Hormone Deficiency
b) Turner Syndrome
c) Primary hypothyroidism
d) Crohnâs Disease
e) Coeliac Disease
f) Skeletal dysplasia
g) Noonan SyndromeThe average age at diagnosis will be estimated. We will compare the yearly number of diagnoses and age at diagnosis before and after the Covid-19 pandemic (2017-2019 vs 2020-2022), to assess any impact on access to routine healthcare and diagnostic abilities. Finally, we will assess inequalities in the number of diagnoses and age at diagnosis by sex, ethnicity and area-level Index of Multiple Deprivation.
Results from this research will provide a rationale for improvements of current growth-screening practice in the UK, by allowing direct comparisons in number and age at diagnosis with other countries that implement formal screening programmes. A large screening programme study is currently in planning. CPRD data will further provide a baseline comparator to assess the efficacy of the tested screening programme. The assessment of differences in outcomes in pre-and-post Covid years, and by sex, ethnicity and deprivation, will provide evidence of inequalities and opportunities to improve access to healthcare by understanding underlying patterns in the diagnosis of these conditions.
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Predicting serious cutaneous adverse reaction due to allopurinol in people with gout — Abhishek Abhishek ...
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Predicting serious cutaneous adverse reaction due to allopurinol in people with gout
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-09
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Edoardo Cipolletta - Corresponding Applicant - University of Nottingham
Georgina Nakafero - Collaborator - University of Nottingham
Richard Riley - Collaborator - University of BirminghamOutcomes:
Incident hospitalisation with a discharge diagnosis of severe cutaneous adverse reactions (i.e., Generalized skin eruption due to drugs and medicaments - ICD10 code L27.0; Bullous erythema multiforme/Stevens-Johnson syndrome - ICD10 code L51.1; Toxic epidermal necrolysis/Lyell syndrome - ICD10 code L51.2) or death with any of these conditions as a cause of death within 100 days from allopurinol prescriptions and an algorithm of drug causality for epidermal necrolysis (ALDEN) scoreâ¥2 (i.e. there is at least a possible causal association between allopurinol initiation and the severe cutaneous adverse reaction).
Description: Lay Summary
Gout is caused by high levels of urate â a waste product of the bodyâs metabolism â which deposits as needle-shaped crystals inside joints. These crystals cause gout flares in which there is severe joint pain, swelling and inability to use the joint for 1-2 weeks.
Technical Summary
Medicines like allopurinol lower the blood uric acid level and are used to treat gout. However, allopurinol can rarely cause a serious allergic reaction in which a large part of the bodyâs skin peels off. People with these side effects can get very ill and many of them require hospitalisation. Some people may even die. There is a genetic marker for this allergic reaction, but this is not widely available. In this study, we will develop a method to estimate the risk of this serious side effect in people with gout treated with allopurinol.
We will use anonymized information from Clinical Practice Research Datalink, linked to hospitalisation and mortality records to build and compare different ways of predicting the risk. These prediction models are used to predict whether something of interest will happen to an individual, and if so whether they should have a different management.Background: Allopurinol, a urate-lowering therapy, is the cornerstone of gout treatment. It can rarely cause severe cutaneous adverse reactions (Stevens-Johnson syndrome/Toxic Epidermal Necrolysis). A prognostic model for this illness has not been developed.
Objectives: To develop and validate a prognostic model for estimating the risk of severe cutaneous adverse reactions due to allopurinol.
Methods: We will use data from the Clinical Practice Research Datalink (CPRD) Aurum and GOLD linked with hospitalisation and mortality records. As these are serious illnesses, they often result in hospital admission and death.
We will use a cohort study design where incident gout patients starting allopurinol for the first time will be followed up from allopurinol initiation until the earliest of severe cutaneous reaction, 100 days follow-up time, death, moving to a different practice, or study end.
Hospitalisation with a discharge diagnosis of generalised skin reaction, Stevens-Johnson syndrome, or toxic epidermal necrolysis or death with any of these conditions recorded as a cause will be the outcome of interest ascertained from hospitalisation and mortality records. A penalized flexible parametric survival model will be used to develop a risk prediction score using CPRD Aurum and with internal validation using bootstrapping to quantify and adjust for optimism. The predictive performance of the score will be validated in CPRD GOLD.
This study will develop a prognostic model to identify people at risk of severe cutaneous adverse reactions from allopurinol. If implemented in clinical practice, it will ensure safer drug prescriptions reducing the risk of these outcomes on patients.
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Does gestational diabetes confer a significant risk of diabetic retinopathy in women with diabetes? A retrospective cohort study using real-world evidence — Frederick Wai Keung Tam ...
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Does gestational diabetes confer a significant risk of diabetic retinopathy in women with diabetes? A retrospective cohort study using real-world evidence
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-07
Organisations:
Frederick Wai Keung Tam - Chief Investigator - Imperial College London
Gabrielle Goldet - Corresponding Applicant - Imperial College London
- Collaborator -
Mark Cunningham - Collaborator - Imperial College LondonOutcomes:
Primary outcome:
⢠new diagnosis of any diabetic retinopathySecondary outcomes:
⢠new diagnosis of referrable diabetic retinopathyDescription: Lay Summary
Diabetes is a condition in sugar levels in the blood are too high. Blindness is one of the most debilitating and common complications of diabetes. Gestational diabetes is a form of diabetes which is first picked up in pregnancy, and which resolves after pregnancy. Women with gestational diabetes are at high risk of later developing long-term diabetes. Gestational diabetes may also carry a significant risk of long-term eye complications associated with the development of diabetes after pregnancy. There is a national eye screening program for people living with long-term diabetes to detect these complications early. This program has been shown to slow the worsening of the disease and/or partially reverse sight problems. This screening program does not include women who have had gestational diabetes (unless they subsequently develop diabetes). Using the Clinical Practice Research Datalink, we aim to compare the long-term risk of diabetic eye disease in women with diabetes whoâve previously had gestational diabetes with the risk in those who never had gestational diabetes. If women with a past of gestational diabetes have a higher risk of diabetic eye problems, it suggests we should perhaps be screening them from the point at which they are found to have gestational diabetes, not just from the point from which they later develop diabetes. In doing this research we would aim to provide evidence that may change national guidelines to prevent a relatively young group of women from developing debilitating eyesight problems.
Technical SummaryDiabetic retinopathy (DR) is one of the leading causes of visual impairment in people of working age in Great Britain; its early detection is key to reversing its progression. There is evidence that, by the time of diagnosis of diabetes, some patients already have DR. In pilot data from a Northwest London dataset, gestational diabetes (GDM) conferred an 18.8% risk of DR within the decade post-partum (c.f. in a cohort of pregnant women without any form of diabetes over the same time-period, this rate was 2.5%). The question is: is GDM a flag for an increased risk of DR, and should we be screening for DR following GDM even before diabetes is formally diagnosed on blood tests? We thus aim to explore the extent to which a past of GDM is a risk factor for DR amongst women living with diabetes. We will compare the risk of developing DR in women with diabetes to the present day. We will perform a multivariate analysis (e.g Cox proportional hazard regression) taking into account demographic and clinical characteristics (for example those with concurrent hypertension, or of particular ethnic groups) to examine their effect on the development of DR. We will use Hospital Episode Statistics (HES) data to ensure as many cases of GDM and DR are captured as possible. The practice-level Index of Multiple Deprivation record will be used to determine the impact of this co-variate on our outcomes. Office of National Statistics death registration will help to interpret the length of longitudinal follow-up data. This study may provide evidence that clinical studies comparing the risk of DR after GDM with that of DR after incident diabetes should be performed, the result of which could change national guidelines to include women with GDM in the eye screening program.
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Factors that can affect antihypertensive response in patients newly diagnosed with hypertension — Samuel Seidu ...
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Factors that can affect antihypertensive response in patients newly diagnosed with hypertension
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-08
Organisations:
Samuel Seidu - Chief Investigator - University of Leicester
Hanad Osman - Corresponding Applicant - University of Leicester
Billy Church - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Navjot Kaur - Collaborator - University of Leicester
pankaj gupta - Collaborator - University of LeicesterOutcomes:
Primary outcomes: Association between age, sex, ethnicity and BMI with blood pressure response in patients newly diagnosed with hypertensive to the 1st antihypertensive medication.
Secondary outcomes: Association between liver function and kidney function tests with blood pressure response in patients newly diagnosed with hypertensive to the 1st antihypertensive medication.
Description: Lay Summary
Hypertension is a progressive long term condition that is characterised by raised blood pressure which can lead to an increased risk of hospitalisation and mortality. As hypertension can initially present as an asymptomatic condition, there may be large numbers of people living with undiagnosed hypertension. Some patients will still have raised blood pressure despite being on multiple antihypertensive medications. This is referred to as resistant hypertension. We will look at responses to medications used for hypertension over time and study how the response to these medications are affected by a variety of factors including demographic related factors and such as age, ethnicity and sex and other factors including BMI, liver and kidney function tests. This study aims to help us understand the reasons behind why certain groups of people are more likely to be resistant to anti-hypertensive medications than others.
Technical SummaryStudy Aims and Objectives: This study aims to investigate the factors influencing the response to antihypertensive medications among patients newly diagnosed with hypertension. Specifically, the objectives are to:
-Assessing how age, sex, ethnicity, and socioeconomic status (indexed by IMD - Index of Multiple Deprivation) influence medication efficacy.
-Evaluate the role of BMI, liver, and kidney function in blood pressure control and medication response.
-Identify patterns of antihypertensive medication response over time to inform tailored treatment strategies.Study Population of Interest: The study will involve adults aged 18 years and above, newly diagnosed with hypertension, identified within the Clinical Practice Research Datalink (CPRD) GOLD and CPRD Aurum databases. Patients will be selected based on diagnostic codes for hypertension, with a follow-up period extending from the date of diagnosis until the end of the study period, death, or loss to follow-up.
Primary Exposures and Outcomes: The primary exposure is the initiation of antihypertensive medication following a new diagnosis of hypertension. The primary outcomes include changes in blood pressure control over time and the incidence of resistant hypertension, defined as uncontrolled blood pressure despite the use of three or more antihypertensive medications, including a diuretic.
Study Design: This is an observational, retrospective cohort study utilising data from CPRD GOLD and CPRD Aurum, linked with Hospital Episode Statistics (HES) Admitted Patient Care and Office for National Statistics (ONS) Death Registration Data to enhance demographic and outcome data.
Methods: Patient demographics, medications, BP readings, BMI, liver and kidney function tests will be extracted from the CPRD databases. Ethnicity data will be refined using CPRD Ethnicity Records. The main statistical modelling approach include:
-Cox Proportional Hazards Model: To analyse time to control blood pressure and the onset of resistant hypertension.
-Multivariable Logistic Regression: To assess impacts of demographics, physiological measures, and socioeconomic status on treatment efficacy.
Source - and 13 more projects — click to show
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Exploring temporal trends in the incidence and prevalence of rheumatoid arthritis, and venous thromboembolism risk factors in women with rheumatoid arthritis in England — Michael McLean ...
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Exploring temporal trends in the incidence and prevalence of rheumatoid arthritis, and venous thromboembolism risk factors in women with rheumatoid arthritis in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-07
Organisations:
Michael McLean - Chief Investigator - Pfizer Ltd - UK
Emma Jones - Corresponding Applicant - Momentum Data Ltd
Andrew McGovern - Collaborator - Momentum Data Ltd
Anita Lynam - Collaborator - Momentum Data Ltd
Eva Henning - Collaborator - Pfizer Ltd - UK
Gulraj Matharu - Collaborator - Pfizer Ltd - UK
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Muhammad (Ashkan) Dashtban - Collaborator - Momentum Data Ltd
Saqib Rana - Collaborator - Pfizer Ltd - UK
Serhan Bahit - Collaborator - Momentum Data LtdOutcomes:
Primary outcomes:
- Incident RA
- Outcomes comprising: VTE (composite of PE or VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE).Secondary outcome:
- Mortality: (1) all-cause, and (2) for VTE-related reasons.Description: Lay Summary
Rheumatoid arthritis (RA) is a chronic condition characterised by joint swelling, damage, and associated health issues that can cause pain, affect mobility, and impair overall quality of life. Importantly, the number of people being diagnosed with RA is increasing worldwide.
People with RA also have a higher chance of getting dangerous blood clots. Understanding more about this risk for women with RA, particularly in those who are taking hormone-based medications that can exacerbate the risk, is essential for effectively managing these patients and enhancing their well-being and life expectancy.
This project has two main parts: the first one is an analysis of how common RA is among English adults, looking at different population groups based on age, sex, ethnic background, geography and socioeconomic status. We will also see how the number of people getting RA has changed over the last twenty years, and estimate how it might change in the future. Additionally, we will examine data from hospitals to determine if the number of people with RA differs from what we observe in GP records.
The second part of the project involves examining the likelihood of blood clots in women with RA who are undergoing hormone treatments, with a particular emphasis on those of child-bearing age or experiencing menopause.
The study will have clear patient benefit by providing information to support health professionals identify who is most at risk of developing RA, and by informing future risk management strategies for women with RA taking hormone-based medications.
Technical SummaryRA is a chronic inflammatory condition causing joint inflammation, damage, and additional complications, lowering functionality and quality of life. RA patients face an increased risk of venous thromboembolism (VTE), further worsening their well-being. This retrospective study of adults in England, utilising data from Clinical Practice Research Datalink (CPRD) Aurum, has two main components: assessing the impact of ethnicity, geography, and socioeconomic status (SES) on RA incidence and prevalence; and comparing VTE risk among female RA patients of different ages with or without hormonal treatments.
People with RA will be identified from primary care records using a case definition based on the work of Scott et al [1]. Overall incidence rates and rates stratified by sociodemographic subgroups (sex, ethnicity, SES and geographic region) will be computed, as will the point prevalence at the end of the 20-year study period to provide a contemporary estimate. Annual incidence and prevalence of RA will be estimated over the 20-year study period, overall and stratified by the same sociodemographic subgroups noted above. Poisson regression (for incidence) and logistic regression (for prevalence) will be used to assess the significance of temporal trends over time, overall and by the same sociodemographic subgroups. Age-period-cohort modelling will be used to project RA incidence rates and prevalence up to 2035 [2, 3]. Additionally, sensitivity analysis will be performed comparing results based solely on primary care data to a broader case definition of RA.
For the assessment of VTE risk in women with RA, incidence will be stratified by the use of oral contraception or HRT. Cumulative incidence curves will be used to illustrate time to VTE development. The risk of VTE will be evaluated in a mixed cohort of prevalent and incident RA cases matched with unaffected controls, using Cox proportional hazards models unadjusted or adjusted for confounders.
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To explore factors associated with non-engagement in asthma care and understand the impact of non-engagement on asthma outcomes — Jennifer Quint ...
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To explore factors associated with non-engagement in asthma care and understand the impact of non-engagement on asthma outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-03
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College London
David Lo - Collaborator - University of LeicesterOutcomes:
Factors associated with poor engagement with asthma care
Asthma outcomes among people with poor engagement (exacerbations, asthma control, mortality)Description: Lay Summary
Asthma is a disease that can make it hard for people to breathe. For some people, asthma is well controlled and they have minimal/no symptoms. For other people, they can have day to day symptoms and their disease is not considered controlled. UK guidelines recommend management that could improve outcomes but, for a range of reasons, some patients do not engage with health services. People may not realise that more can be done to help them improve their asthma, they may find it hard to access the right care at the right time, they may not take their inhalers as recommended and people with âdifficult-to-controlâ asthma may struggle to attend appointments at a hospital clinic many miles away. People from ethnic minority groups, deprived communities, or living in remote areas may have problems accessing appropriate care for their asthma. We know that for these people, asthma outcomes are often worse.
This work is part of a larger grant, where our long-term aim is to improve services so that people can access and engage with care that meets their individual needs and preferences. In this preliminary work, we will use routine healthcare data to explore how people use (or do not use) asthma services (for example, do they attend their annual asthma reviews) and determine if there are certain factors that predict who does not engage with healthcare services. One of the groups we are particularly interested in are those at greatest risk of poor asthma control (frequent asthma attacks).
Technical SummaryDespite three decades of evidence-based guideline recommendations, UK asthma outcomes are worse than other high-income European countries. Patients often miss review appointments and/or take their asthma preventer treatment infrequently. Whist UK guidelines recommend management that could improve outcomes, for a range of reasons, best (or even adequate care) is too often not accessible or does not engage patients. People may not realise that more can be done to help them improve their asthma, they may find it hard to access the right care at the right time, they may not take their inhalers as recommended and people with âdifficult-to-controlâ asthma may struggle to attend appointments at a hospital clinic many miles away. People from ethnic minority groups, deprived communities, or living in remote areas may have problems accessing appropriate care for their asthma. We know that for these people, asthma outcomes are often worse.
Using routine primary care data from Clinical Practice Research Datalink Aurum linked with deprivation status (IMD) and rural-urban classification, Hospital Episode Statistics (APC, A&E and Outpatient), and ONS mortality data we will determine factors associated with non-engagement in asthma care (e.g. missed annual asthma reviews, poor adherence with treatment). We are particularly interested in understanding if non-engagement is worse in people at greatest risk of poor asthma control (e.g. as defined by frequent asthma attacks/high reliever usage). The study period will be 2010 to the most recent available linked data. We will undertake a cohort study and then explore asthma outcomes (e.g. exacerbations) comparing those who have poor engagement with patients who do not have poor engagement. This work will feed back into a larger NIHR funded study.
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Safety of Paxlovid for the Treatment of COVID-19 During Pregnancy: Investigating Adverse Pregnancy, Maternal and Offspring Outcomes — Andrea Margulis ...
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Safety of Paxlovid for the Treatment of COVID-19 During Pregnancy: Investigating Adverse Pregnancy, Maternal and Offspring Outcomes
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-13
Organisations:
Andrea Margulis - Chief Investigator - RTI Health Solutions ( USA )
Becky MacKay - Corresponding Applicant - RTI Health Solutions ( USA )
Anne-Elie Carsin - Collaborator - RTI Health Solutions ( USA )
CRISTINA REBORDOSA GARCIA - Collaborator - RTI Health Solutions ( USA )
David Martinez - Collaborator - RTI Health Solutions ( USA )
Estel Plana Hortoneda - Collaborator - RTI Health Solutions ( USA )
Jaume Aguado - Collaborator - RTI Health Solutions ( USA )
JOSEP RAMON MARSAL MORA - Collaborator - RTI Health Solutions ( USA )
Katica Boric - Collaborator - RTI Health Solutions ( USA )
Maria Foraster Pulido - Collaborator - RTI Health Solutions ( USA )
Nuria Saigi - Collaborator - RTI Health Solutions ( USA )
Raquel Garcia Esteban - Collaborator - RTI Health Solutions ( USA )
Sandra Bertran - Collaborator - RTI Health Solutions ( USA )
Susana Perez-Gutthann - Collaborator - RTI Health Solutions ( USA )
Xabier Garcia de Albeniz - Collaborator - RTI Health Solutions ( USA )Outcomes:
Prespecified study outcomes: Spontaneous abortion; Elective termination; Stillbirth; Preterm delivery (all, iatrogenic, and spontaneous); Major congenital malformations; Intrauterine growth retardation/small for gestational age; Gestational diabetes; Gestational hypertension; Postpartum haemorrhage; Maternal death.
Exploratory outcomes: empirically identified outcomes identified from diagnosis codes from outpatient diagnoses, hospitalisation discharge diagnoses and emergency department diagnoses recorded up to 1 month after the Paxlovid dispensing date among eligible Paxlovid-exposed individuals.
Description: Lay Summary
Paxlovid is an antiviral used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. The safety of Paxlovid in pregnant women is unknown.
This study aims to explore the safety of Paxlovid when used in pregnancy. The primary objective is to estimate the proportion of several adverse outcomes in pregnant women with COVID-19 who are treated with Paxlovid, and to estimate the risk for these outcomes in pregnant women treated with Paxlovid compared to the risk in pregnant women with COVID-19 who use the antiviral molnupiravir (or comparable antivirals) or who are untreated. The outcomes are miscarriage, induced abortion, death of the fetus, early delivery, birth defects, poor growth of the fetus, diabetes during pregnancy, hypertension during pregnancy, haemorrhage after giving birth, and maternal death. The secondary objective is to assess other maternal outcomes based on diseases observed among pregnant women who used Paxlovid.
The study will use existing data from CPRD in the UK, as well as data from France and Spain. Analyses will follow a common study protocol and statistical analysis plan. Results from each data source will be combined using statistical techniques. The findings of this study will inform about the safety of Paxlovid in pregnant women.
This study is a commitment to the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency and is registered in a repository for regulatory and other studies (EU PAS Register reference number: EUPAS50117).
Technical SummaryPaxlovid is an antiviral used to treat COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progression to severe COVID-19. The safety of Paxlovid in pregnant women is unknown.
The primary objective is to estimate the prevalence, prevalence ratio, and prevalence difference of several adverse outcomes in women with COVID-19 who are exposed to Paxlovid during pregnancy, compared with those in women with COVID-19 who are exposed to molnupiravir (or other comparable medications for COVID-19) during pregnancy, or to women with COVID-19 unexposed to any study medications during pregnancy. The prespecified study outcomes are spontaneous abortion, elective termination, stillbirth, preterm delivery, major congenital malformations, intrauterine growth retardation/small for gestational age, gestational diabetes, gestational hypertension, postpartum haemorrhage, and maternal death. The secondary objective is to assess additional maternal outcomes to be identified based on conditions appearing in the study population after exposure to Paxlovid (exploratory outcomes).
Molnupiravir, an antiviral with a similar recommended usage, will be the active comparator, where available; other drugs may be incorporated as active comparators as more information becomes available. The second comparator group is women with COVID-19 unexposed to any study medication during pregnancy.
The study will use existing data from the UK (CPRD), France and Spain translated into the ConcePTION common data model. Analyses will follow a common protocol and statistical analysis plan, and will use centralized programming. Analyses will include descriptive and comparative components, including propensity score models, and bootstrapping to calculate the confidence intervals. Data-source-specific results will be combined via meta-analysis.
This study is a commitment to the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency. This protocol is registered in the EU PAS Register (EUPAS50117).
This is the first out of two data extractions for this study.
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Osteoporotic fractures and kidney injury in people living with an ileostomy — David Humes ...
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Osteoporotic fractures and kidney injury in people living with an ileostomy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-21
Organisations:
David Humes - Chief Investigator - University of Nottingham
Christopher Lewis-Lloyd - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Joe West - Collaborator - University of NottinghamOutcomes:
⢠Specifically, the incidence rates of:
ï® Acute kidney injury and osteoporotic fractures in patients with and without a new ileostomy.
ï® Mortality in those who develop acute kidney injury or osteoporotic fracture with and without a new ileostomy.Description: Lay Summary
13,000 new ileostomy operations are performed in England each year. An ileostomy or stoma is a surgical operation where the small bowel is diverted through an opening in the abdominal wall to allow for bowel waste to be removed. The most common indications are inflammatory bowel disease and bowel cancer. The formation of an ileostomy alters bowel functioning that can affect nutrition which could lead to the development of long-term diseases (kidney disease, osteoporotic fractures etc.) but the evidence for this remains limited. Osteoporotic, otherwise termed fragility, fractures result from bone disease where bone tissue and strength is lost, making them weak and susceptible to injury.
Objectives:
⢠To determine the occurrence of:
ï® Acute kidney injury and osteoporotic fractures in patients with an ileostomy.
ï® Death in patients with an ileostomy who develop acute kidney injury and osteoporotic fractures.Design:
We will use data from three large electronic health records, the Clinical Practice Research Datalink, Hospital Episode Statistics and Office of National Statistics to determine the incidence of kidney injury and osteoporotic fractures in patients with a new ileostomy formation due to benign and malignant colorectal conditions. All data has already been recorded, with no requirement for further patient input.
Outcomes and patient benefits:
Determining the risk of developing long-term conditions after an ileostomy will guide clinicians and policymakers to develop targeted advice and interventions for patients. By further understanding the risks of developing complications related to ileostomies, we hope to improve the health of patients living with them.
Technical SummaryBackground:
13,000 ileostomy operations are performed in England annually to treat various colorectal conditions (predominantly inflammatory bowel disease and colorectal cancer). Ileostomy creation alters bowel physiology, potentially affecting a patientâs nutrition, conferring risk to complications such as malabsorption of fat-soluble vitamins, fluid and electrolytes leading to acute kidney injury (AKI) and bone mineral density loss. These effects could lead to kidney disease and osteoporotic fractures but evidence for these conditions remains scarce.
Objectives:
⢠Determine the incidence of:
ï® AKI and osteoporotic fractures in ileostomy patients.
ï® Mortality of ileostomy patients who develop AKI and osteoporotic fractures.Design:
Linked primary and secondary care databases (CPRD Aurum and HES) will be used to establish a cohort of patients undergoing new ileostomy formation from 2000-2023. Patients with a new ileostomy will be age and sex matched to the general population on a 1 case to 10 control ratio with a randomly assigned pseudo index date. Patients with new ileostomy formation will be identified using Office of Population Censuses and Surveys codes from HES data and their demographics from CPRD data. Linked IMD data will be used to determine levels of deprivation. Mortality will be assessed from Office of National Statistics data. The incidence per 100,000 person-years of follow-up of AKI and osteoporotic fractures will be obtained from linked HES and CPRD data. Confounders of the intended outcomes will be controlled for using either Cox or Poisson regression models.
Outcomes:
We will provide population-based estimates of incidence for AKI and osteoporotic fractures following ileostomy formation. Determining the risk of developing these conditions after an ileostomy will guide clinicians and policymakers to develop targeted advice and interventions for patients. By further understanding the risks of developing complications related to ileostomies, we hope to improve the health of patients living with them.
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Isotretinoin exposure during pregnancy — Craig Allen ...
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Isotretinoin exposure during pregnancy
Datasets:GP data, CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-20
Organisations:
Craig Allen - Chief Investigator - MHRA
Craig Allen - Corresponding Applicant - MHRAOutcomes:
Rates/proportions of men and women prescribed isotretinoin; Numbers/proportions of pregnancies exposed to oral isotretinoin; Age-groups of women with maternal isotretinoin exposure (<12 years, 12-17 years, 18-24 years, 25-34 years, 35-44 years, 45+ years); Pregnancy outcomes following maternal isotretinoin exposure; Distribution (histogram) of the numbers of isotretinoin prescriptions issued in men, women and exposed pregnancies stratified by age-groups; Numbers/proportions of isotretinoin exposed women where prescriptions ended before a pregnancy.
Description: Lay Summary
Isotretinoin is used to treat severe acne. It should only be prescribed by physicians with expertise treating severe acne which has not responded to other treatments, such as antibiotics and creams or gels. Isotretinoin is known to cause birth defects in infants exposed when mothers take the drug whilst pregnant, as well as mental health and sexual function side effects. Because of the risk to infants, women prescribed isotretinoin who have the potential to become pregnant are required to enter a Pregnancy Prevention Programme (PPP) so they are fully informed of the risks and to prevent potential harm to an unborn baby from isotretinoin exposure. The PPP includes the agreement to use contraception and undergo pregnancy testing during, and one month subsequent to, treatment. Although isotretinoin is mainly prescribed by specialists in hospital settings, some prescribing can take place in primary care by general practitioners with an extended role (GPwER). The Medicines and Healthcare products Regulatory Agency (MHRA) has received information that some women are being exposed to isotretinoin during pregnancy, but the extent of this is unknown. There is also interest in understanding the extent of GPwER isotretinoin prescribing more broadly due to wider risks of mental health and sexual function side-effects. This feasibility study aims to estimate the available sample size for a potential future study on isotretinoin prescribing in primary care and exposure during pregnancy. This work will support possible further regulatory action to ensure the safe use of isotretinoin.
Technical SummaryIsotretinoin is an orally administered systemic retinoid used to treat severe acne where other treatments have proved ineffective. Isotretinoin is known to cause birth defects and is also associated with neuropsychiatric and sexual function side-effects. Isotretinoin is predominantly prescribed by specialists in secondary care and to a lesser extent by GPs with an extended role (GPwER). Prior to initiating treatment, patients must sign an Acknowledgement of Risk Form (AoRF) indicating they have been informed of the potential risks described above. Women of child-bearing potential must undergo pregnancy testing before, during and 1 month after ending treatment and use contraception as part of the PPP. The MHRA has received information that some women are being exposed to isotretinoin during pregnancy, but the extent of this is unknown. There is also interest in understanding the extent of GPwER isotretinoin prescribing more broadly in men and women of all ages because of other side effects. This feasibility study aims to estimate the available sample size for a potential future study on isotretinoin prescribing in primary care and exposure during pregnancy. The study will use the Aurum primary care data to ascertain isotretinoin prescriptions and the pregnancy register to ascertain pregnancy dates from 1st January 2015 onwards.
The objectives are to:
1. Calculate rates/proportions of men and women prescribed oral isotretinoin and their age distribution.
2. Calculate proportions of pregnancies exposed to oral isotretinoin and the maternal age distribution.
3. Tabulations of isotretinoin prescribing falling before and within pregnancy dates and their outcomes.
This feasibility study and any future resulting research will improve our understanding of the effectiveness of current regulatory requirements for isotretinoin prescribing, and the need for further intervention and monitoring, to ensure patient safety.
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Adverse cardiovascular impact of erectile dysfunction in people with and without type 2 diabetes — Mohammad Ali ...
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Adverse cardiovascular impact of erectile dysfunction in people with and without type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-05-09
Organisations:
Mohammad Ali - Chief Investigator - University of Leicester
- Corresponding Applicant -
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Setor Kunutsor - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
Primary (cardiovascular) outcomes: 3-point MACE (major adverse cardiovascular events) defined as nonfatal stroke, nonfatal myocardial infarction and cardiovascular death.
Secondary outcomes: other cardiovascular endpoints and all-cause death.
Description: Lay Summary
People with diabetes, a condition characterised by high blood sugar levels, are more likely to develop heart disease, which also leads to death. Men with diabetes are also more likely to develop erectile dysfunction (ED) commonly known as impotence, which is well known to cause heart disease. The relationship between ED and heart disease is so strong that it has been proposed that both diseases are different manifestations of the same disease. Given that people with diabetes have a higher risk of heart disease than those without diabetes, it would be reasonable to say that people with ED are more likely to develop heart disease and die when they have diabetes than when they do not have diabetes. However, recent evidence seems to suggest that the relationship between ED and heart disease is similar in people with and without diabetes. No study has actually directly compared the relationship in people with and without diabetes, so it is difficult to know. Using available information, we will study if people with ED are more likely to develop heart disease and die when they have diabetes than when they do not have diabetes. The findings from this study could provide more information on whether people who have ED with no diabetes should be treated as if they had both ED and diabetes. There are medications that can reduce the chances of developing heart disease irrespective of whether one has diabetes or not.
Technical SummaryIt is uncertain if ED confers an excess risk of cardiovascular disease (CVD) and mortality in patients with T2D compared with no T2D. Using CPRD data linked to Hospital Episode Statistics Admitted Patient Care (HES APC) and Office for National Statistics (ONS) mortality data, the study will investigate if the presence of ED confers an excess risk of adverse cardiovascular outcomes in patients with T2D compared with those without T2D. A retrospective cohort study design will be used for the analysis. Cox regression analysis will be used to model the associations of ED (exposure defined using medical codes or medication history (Avanafil, Sildenafil, Tadalafil, Vardenafil) to 3-point major adverse cardiovascular events (MACE) defined as nonfatal stroke, nonfatal myocardial infarction and cardiovascular death.
Adjustment for key confounders such as age, sex, ethnicity, smoking, body mass index, comorbidities (such as depression and hypertension), and medications (Anti-hypertensives such as: ACE inhibitors, angiotensin-2 receptor blockers (ARBs), calcium channel blockers, diuretics, beta-blockers; Antidepressants: Selective serotonin reuptake inhibitors (SSRIs) and other categories of antidepressants; Diabetic drugs such as: Metformin, Sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists) and the inclusion of an interaction term to explore whether the effect of ED is modified by T2D status.
Using interaction analyses, we will also assess for evidence of effect modification by important characteristics such as age, body mass index, and ethnicity. There is potentially significant public health benefit. ED at the population level is understudied, and how T2D interacts with ED, which leads to the development of cardiovascular disease, has not been elucidated. Therefore, our study may provide a significant opportunity for creating public health interventions to identify and intervene earlier for preventative treatment for patients with ED.
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ID-410: Evaluation of the clinical impact and cost-utility of a comprehensive digital diabetes self-management platform (MyWay Diabetes): proposal for a mixed-methods, pragmatic, real-world evaluation — University of Manchester...
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ID-410: Evaluation of the clinical impact and cost-utility of a comprehensive digital diabetes self-management platform (MyWay Diabetes): proposal for a mixed-methods, pragmatic, real-world evaluation
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: University of Manchester
Description: Diabetes patients.
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ID-405: The impact of Alzheimer’s disease progression on resource use, societal costs and the effect of hypothetical amyloid targeting therapies (ATTs) — Imperial College Health Partners ...
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ID-405: The impact of Alzheimer’s disease progression on resource use, societal costs and the effect of hypothetical amyloid targeting therapies (ATTs)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Alzheimer’s Disease.
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ID-411: GIRFT Children’s Asthma NW London ICB pilot project — NHS England...
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ID-411: GIRFT Children’s Asthma NW London ICB pilot project
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: NHS England
Description: Asthma.
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ID-408: Metrics to support a system-wide review of Brent ICP — Brent Council...
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ID-408: Metrics to support a system-wide review of Brent ICP
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: Brent Council
Description: Review.
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ID-409: NWL Bi-Borough Evaluation Framework — NHS NWL...
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ID-409: NWL Bi-Borough Evaluation Framework
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: NHS NWL
Description: Evaluation framework.
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ID-406: Carepath Data- Identifying risks and opportunities for better outcomes in Cardio-Metabolic care pathways — Imperial College Health Partners...
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ID-406: Carepath Data- Identifying risks and opportunities for better outcomes in Cardio-Metabolic care pathways
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Cardio-metabolic care.
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ID-407: Evaluation of virtual consultations in primary care: assessing the effectiveness of eConsult — Imperial College London...
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ID-407: Evaluation of virtual consultations in primary care: assessing the effectiveness of eConsult
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Virtual consultations.
Source
2024 - 04
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Burden of mental health conditions in athletes: A retrospective open cohort study in primary care — Joht Singh Chandan ...
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Burden of mental health conditions in athletes: A retrospective open cohort study in primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-16
Organisations:
Joht Singh Chandan - Chief Investigator - University of Birmingham
Kirsty Brown - Corresponding Applicant - University of Birmingham
Jennifer Cumming - Collaborator - University of Birmingham
Mary Quinton - Collaborator - University of Birmingham
Shamil Haroon - Collaborator - University of BirminghamOutcomes:
1) Explore the risk of developing common mental health disorders in athletes
a. Depression
b. AnxietyDescription: Lay Summary
Mental health disorders/illnesses include anxiety, depression, obsessive compulsive disorder and eating disorders. Within the athlete population there is suggested to be a similar prevalence of mental health issues/disorders in athletes and the general population, even though physical activity/exercise are seen to improve mental health and be protective against mental ill health. To date, there has been increasing research on the prevalence of mental health disorders and illness in athletes, compared to non-athletes, and discussions of their care needs. However, the research on athlete mental health has mostly been small scale studies, with a lack of large scale and epidemiological studies. In particular, there is a lack of research on the prevalence of mental health disorders in athletes in the UK.
In the UK primary care is often the first port of call for those experiencing mental health difficulties within the UK. Although top level athletes may have access to mental health support beyond the NHS services, many athletes will not be able to access support beyond the NHS. It is important to understand how many athletes may be accessing mental health support through primary care, to understand how many athletes may need support suited to their unique needs.
There is a suggestion from the limited research, that there may be differences in mental health disorders in athletes depending on their age, sex, deprivation and ethnicity. However, the evidence is not clear from the small-scale studies conducted. Therefore, research using UK primary care data will contribute to filling this gap.
Technical SummaryThis study aims to be the first study using primary care data to explore the epidemiology of common mental health disorders (anxiety and depression) in athletesâ using the CPRD AURUM dataset. The population of interest will be all patients who contribute to AURUM from 1st January 2001 to the latest available study date. Exposed patients will be defined as those who have a SNOMED code indicating they are an athlete. The outcomes to be measured are the prevalence of anxiety, depression, and combined anxiety/depression. This study will be primarily conducted using CPRD AURUM but will be supplemented with data on indices of multiple deprivation to account for deprivation as a confounder in this relationship.
We propose to undertake a of population based retrospective open cohort studies to explore the risk of developing mental ill health following a recorded exposure as being an athlete and in particular if the risk varies in certain sub-groups (age, sex, ethnicity and deprivation) of those exposed. We will calculate the incidence rate of each outcome of interest and where suitable use a Cox proportional Hazard model to describe risk. This will be the first study of its kind to help understand the burden of mental ill health in this population. In particular, through stratified analysis, we will be able to demonstrate which groups may have the greatest need to target resources towards.
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Feasibility study: identifying Dravet Syndrome and Lennox-Gastaut Syndrome from all epilepsies recorded in Clinical Practice DataLIink linked to Hospital Episodes Statistics datasets — Indraraj Umesh Doobaree ...
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Feasibility study: identifying Dravet Syndrome and Lennox-Gastaut Syndrome from all epilepsies recorded in Clinical Practice DataLIink linked to Hospital Episodes Statistics datasets
Datasets:GP data, CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register; CPRD GOLD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.Outcomes:
Seizures types, frequency and duration
Mortality (cause-specific, overall; number, and proportions)
Survival (feasibility of defining and estimating disease-free or progression-free, overall) Hospitalisation, outpatient visits and general practice consultation (cause-specific and overall)
Comorbidities, including cognitive dysfunction
Specialty caring for DS/LGS
Referal to neurological and social careBasic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained. Rates in person-time will be calculated wherever appropriate.
Description: Lay Summary
Epilepsy is a condition where the brain does not function properly and causes seizures. These makes the body move randomly and fast. In some cases, it can lead to breathing difficulties, loss of consciousness and even death. Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) are rare types of epilepsy that start during early childhood and can cause severe negative consequences, including developmental problems and premature death in some cases. Their carers are also impacted by poor quality of life and work restrictions. DS and LGS are often misdiagnosed leading to those affected receiving the wrong treatment. This feasibility study intends to find a method to identify with DS and LGS patients using their healthcare records from the Clinical Practice Research DataLink linked to the Hospital Episodes Statistics. This would require that patients with epilepsies are screened for the types of seizures that are related to DS and LGS, including when they started and ended, and their responses (including unresponsiveness) to treatments that were prescribed. The feasibility study will also assess what possible data are available from the general practitionersâ and the hospitalsâ records on complications, referral to neurological and social care as well as causes of hospitalisations and death. This information will be used to make decisions to conduct future research on DS and LGS to assist healthcare practitioners and service providers understand how many patients suffer from DS and LGS and to assess their response to treatment with a view to improve their care.
Technical SummaryDravet Syndrome (DS) and LennoxâGastaut syndrome (LGS) are rare epileptic encephalopathies which start in early childhood and continue into adulthood. Both syndromes are characterised as drug-resistant and are associated with cognitive dysfunction and poor quality of life. Carers of DS/LGS patients can also experience poor quality of life too and work restrictions. Misdiagnoses are not uncommon and can delay the correct treatment. The codes utilised within the Clinical Practice Research DataLink (CPRD) linked to the Hospital Episodes Statistics (HES) to record DS/LGS are inadequate to identify them, especially as patients can be misdiagnosed. Additional criteria, e.g. type of seizures (e.g. myoclonic), resistance to treatment, will also be used to identify DS/LGS. This feasibility study will aim to identify which criteria are required to enable their identification and will screen the CPRD and HES records (Inpatient, Outpatient and Accident & Emergency datasets) of epilepsy patients for the relevant fields that contains these criteria, which will then be used to construct separate algorithms to be used for future research. The feasibility study will also assess what data are available from the general practitionersâ and the hospitalsâ records on complications (inc. on Mother-Baby Link), referral to neurological and social care as well as causes of hospitalisations and death (from the ONS death registry). Data from this feasibility study will enable to the identification of DS and LGS patients (especially the latter which has heterogenous aetiology) for the conduct of future research will describe the epidemiology, health resource utilisation and cost burden of these epilepsies on the healthcare system in England as well as their impact on the sufferersâ quality of life. This data will be published in the public domain for healthcare practitioners and service providers to utilise in order to improve healthcare provision and treatment outcomes for patients with DS and LGS.
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Epidemiology of allergic rhinitis in England: A retrospective cohort study in UK primary care data. — Diane Hatziioanou ...
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Epidemiology of allergic rhinitis in England: A retrospective cohort study in UK primary care data.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-17
Organisations:
Diane Hatziioanou - Chief Investigator - CPRD
Chisomo Mutafya - Corresponding Applicant - CPRD
Daphne Martin - Collaborator - CPRD
Hilary Shepherd - Collaborator - CPRD
Michael Jones - Collaborator - Thermo Fisher Scientific Inc.
Rachael Williams - Collaborator - CPRDOutcomes:
AR incidence; AR presentation incidence; Asthma incidence; referral records for AR; primary healthcare HCRU associated with AR and AR presentation, assessed by:
a) GP consultations, including telephone consultations.
b) Hospital inpatient admissions
c) Referrals to specialistsDescription: Lay Summary
Allergic rhinitis (AR) is the medical term given for inflammation of the nasal lining caused by an allergic trigger and can lead to developing asthma. Symptoms are varied but can include sneezing, an itchy nose, congestion (blocked, stuffy, or runny nose), and coughing. In recent years the number of people suffering from this condition have increased leading to a higher burden on the health care system. Reducing exposure to allergic triggers and use of over-the-counter (OTC) medicines can alleviate symptoms; however, when triggers are not immediately obvious, or OTC medicines donât help, allergy testing becomes necessary. Patients are typically referred to specialist units for testing, diagnosis and management. This sometimes results in patients grappling with persistent symptoms while awaiting their referral appointment date.
This study aims to understand the scale and extent of AR in England by exploring patient trajectories in the healthcare system and examining outcomes.The study findings will enhance our understanding on the frequency of AR in England, its management, and serve as a valuable resource for healthcare resource planning in the context of respiratory diseases.
Technical SummaryAR is a common condition affecting 10-15% of children and 26% of adults in the UK. Although often regarded as a trivial problem, it significantly affects quality of life, work, school performance and attendance, and is a risk factor for the development of asthma. Allergic rhinitis has tripled in the last 20 years resulting in considerable health care utilisation. By reducing triggers, symptoms can be controlled, reducing hospital visits and the risk of developing asthma. Currently, patients are typically referred to a hospital specialist for testing, which can cause delays in diagnosis, putting pressure on primary care in the intervening period, because of poorly controlled symptoms. The aim of this study is to describe the burden and unmet need of AR among patients in England from 2009-2019. The proposed study will look at epidemiology of AR and how its symptoms are managed within the health care system. Data sources include CPRD Aurum linked to secondary data. Hospital episodes statistics (HES) admitted patient care (APC) and HES outpatient (OP) records will be used to determine hospitalisations and health care usage, while patient index of multiple deprivation (IMD) will be used to provide baseline deprivation status. Descriptive analyses will include incidence of rhinitis symptom presentation, incidence of AR diagnosis and referral rates. The number of general practitioner (GP) appointments and hospitalisation rates will be used to understand the primary care and secondary care resource use associated with the study population. The study will enhance our understanding of the burden of AR in England. It will also highlight the barriers and opportunities for provision of improved health care services for patients with AR.
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Evaluating the annual learning disability health check for young people in England — Rakhee Shah ...
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Evaluating the annual learning disability health check for young people in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-16
Organisations:
Rakhee Shah - Chief Investigator - Imperial College London
Rakhee Shah - Corresponding Applicant - Imperial College London
Dougal Hargreaves - Collaborator - Imperial College London
Irene Petersen - Collaborator - University College London ( UCL )
Mark Cunningham - Collaborator - Imperial College LondonOutcomes:
The following outcomes will be measured:
Study 1:
⢠Proportion of young people on the learning disability register as a proportion of all young people on the GP registers, then combined by geographic region in England.
⢠Characteristics of young people on the learning disability register such as gender, ethnicity, deprivation quintile
⢠Proportion of eligible young people aged 14-25 that uptake the annual LD health check.Study 2:
⢠Emergency hospital admission rate
⢠Mortality rate (all cause and cause-specific mortality)
⢠Uptake rate of the annual flu vaccine
⢠Outpatient attendance rateDescription: Lay Summary
This project aims to improve the health and life chances of young learning-disabled people. People with a learning disability have more health problems and die much earlier than the general population. Health services are difficult for young learning-disabled people to access, particularly when they are being transferred from children to adult services, which contributes to poorer health.
In response to concerns about health care for this group, NHS England introduced annual health checks for all people with a learning disability aged over 14. These checks help to catch health problems early and provide treatment earlier. But in 2019-20, only about 38.7% of young people who could go actually went. It is also unknown whether health checks make any important lasting difference to health for young people.
Our project therefore aims to answer the following questions using anonymous GP and hospital data:
1) How many young people aged 14-25 are on the learning disability register and how does this vary across England?
2) Are there differences in factors such as ethnicity and poverty, between young people who attend for a learning disability health check and those that do not?
3) Can check-ups improve the health of young people with learning disabilities? This might mean fewer hospital admissions, better uptake of the flu vaccine and fewer early deaths.Our research findings will help to inform the NHS and Government on how to increase attendance for health checks and provide new knowledge on the impact of health checks for young people.
Technical SummaryPeople with learning disabilities experience stark health inequalities and die much younger when compared to the general population. Poor quality and access to healthcare services which lead to these inequalities begin in childhood. The transition from childrenâs services to adult services is challenging for young people with a learning disability, as it combines a change of services/professionals at a time when they are also wider changes to their lives.
Key policy reports have highlighted the annual learning disability health check (ALDHC) as a key intervention to reducing health inequalities for young people with a learning disability. Only people on the GP learning disability register are eligible to be invited for an ALDHC. Since its introduction there has been little research on the health impacts (e.g. uptake of the annual flu vaccine, unplanned emergency admissions, longer-term mortality) of attending for an ALDHC, specifically for young people.
Using anonymous Clinical Practice Research Datalink (CPRD) Aurum GP records and linking these records to, CPRD ethnicity records, hospital episode statistics, accident and emergency, admitted patient care, outpatient records, and Office of National statistics mortality data, our project aims to:
⢠Describe the geographic variation in young people aged 14-25 on the learning disability register across England.
⢠Describe key socio-demographic risk factors for poor attendance at annual learning disability health checks.
⢠Use statistical regression models to analyse whether attending health checks have an impact on reducing unplanned emergency hospital admissions, increasing outpatient attendance rates and uptake of the flu vaccine, and reducing longer-term mortality, for young people.Our research will inform policy makers on whether the ALDHC is an effective intervention to invest in to improve the health of young people with learning disability. Our research will also provide information on how to increase uptake of the ALDHC by young people.
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Multi-state model and Joint models of recurrent cardiovascular disease — Amand Schmidt ...
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Multi-state model and Joint models of recurrent cardiovascular disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-04
Organisations:
Amand Schmidt - Chief Investigator - University College London ( UCL )
Rikesh Bhatt - Corresponding Applicant - University College London ( UCL )Outcomes:
Primary outcome: time till MMVD occurrence.
Secondary outcome: occurrence of individual disease contributing the MMVD composite, recurance of MMVD, and all cause mortality.
Description: Lay Summary
If you have diabetes, you're more likely to face health problems like heart and blood vessel diseases. These issues can also affect other parts of your body, like your eyes, brain, and kidneys. Having diabetes puts you at risk of getting several diseases over your lifetime. This can lead to health complications, making life shorter and less enjoyable. This research project uses data from the Clinical Practice Research Datalink to learn about how diseases develop over time in people with diabetes. The goal is to find out what factors contribute to these health issues and create tools that can predict the risk of having multiple health problems. The findings would enable healthcare professionals to offer preventive care to patients with an elevated risk of developing these diseases and to determine the best time to start treatment.
Technical SummaryThe study aims to determine the extent to which risk factors correspond with the occurrence and timing of macro- and microvascular diseases (MMVD), encompassing the conditions cardiovascular disease (CVD), stroke, vascular dementia, peripheral arterial disease, abdominal aortic aneurysm, nephropathy, retinopathy, and microangiopathy. Of particular interest is MMVD in individuals with type 2 diabetes mellitus (T2DM), who face elevated risks. We seek to determine if these risk factors influence the progression of adverse T2DM outcomes. Initially, we will assess variables in QRISK3, a CVD risk algorithm. We will subsequently expand the list of variables beyond the QRISK3 predictors using the wealth of available EHR data.
Data sources:
Data will be drawn from hospital episode statistics (HES), primary care records, and Office for National Statistics (ONS) data. These sources will provide MMVD diagnoses, fatal events, patient demographics, prescriptions, and lifestyle factors.
The study design:
A cohort study comprising individuals aged 30 at enrollment without prior MMVD history, using data from 1998 to 2021. Participants will be followed until death, MMVD diagnosis, or loss to follow-up. Stratification based on T2DM diagnosis will reflect the MMVD burden among diabetic individuals.Proposed analyses:
Analyses will involve Cox regression and multi-state models (MSM) to predict MMVD risk, capturing transitions between health states and MMVD. The parameters of the models would estimated by maximising the likelihood function using a general purpose optimiser. MSMs will provide insight to the risk of progressing from a healthy state without MMVD, towards various disease onset, reccurance and death from other causes or MMVD. Ethnicity, sex, age, socioeconomic status, and diabetes will define subgroup indicators. Model performance will be assessed using an 80/20% split for training and testing, evaluating discrimination and calibration.
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Clinical Practice Research Datalink GOLD has changed: an updated overview of its content and characteristics to improve clinical research using this data source. — Antonella Delmestri ...
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Clinical Practice Research Datalink GOLD has changed: an updated overview of its content and characteristics to improve clinical research using this data source.
Datasets:GP data, Numbers and total years of follow-up of historical and current patients overall and per each UK constituent country, stratified by age, sex and ethnicity, will be reported. For current patients, also the socioeconomic status (measured by GP practice area level deprivation and urban/rural classification) will be investigated.
The number of current patients with a record of the following health indicators will be reported: asthma, diabetes, hypertension, heart disease, obesity, stroke and smoking status.Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-04
Organisations:
Antonella Delmestri - Chief Investigator - University of Oxford
Antonella Delmestri - Corresponding Applicant - University of Oxford
Eleanor Axson - Collaborator - CPRD
Maria Sanchez - Collaborator - University of Oxford
Sonia Coton - Collaborator - CPRDOutcomes:
Numbers and total years of follow-up of historical and current patients overall and per each UK constituent country, stratified by age, sex and ethnicity, will be reported. For current patients, also the socioeconomic status (measured by GP practice area level deprivation and urban/rural classification) will be investigated.
The number of current patients with a record of the following health indicators will be reported: asthma, diabetes, hypertension, heart disease, obesity, stroke and smoking status.Description: Lay Summary
Clinical Practice Research Datalink (CPRD) GOLD is a large and influential database of clinical practices from the United Kingdom (UK). CPRD GOLD has been used for decades in national and international medical research: its content and characteristics were published in 2015. However, in recent years there have been significant changes in this data source, with many new clinical practices joining from Scotland, Wales, and Northern Ireland, and with most of the active clinical practices in England leaving. These changes and their effects have not been documented yet and researchers using CPRD GOLD need revised information to design and conduct their studies appropriately.
Technical Summary
Without clear evidence, users of CPRD GOLD might design their studies incorrectly and misinterpret analyses results by using an out-of-date data resource profile as a reference. The lack of revised information might lead researchers to reach and publish the wrong conclusions, which could damage patientsâ lives by affecting public health policies, clinical care, and drug safety monitoring.
This study aims to provide these missing up-to-date details and guidance on the content and usage of CPRD GOLD, overall and by UK constituent country. Additionally, it also aims to produce a manuscript that researchers can use as a reference for their current and future research. This project will benefit patients in the UK indirectly by filling the current knowledge gap about CPRD GOLD, and enabling researchers to conduct their studies properly and influencing health decision making correctly.CPRD GOLD is a large, rich, and influential UK clinical practice database, which has been used for decades in national and international medical research. Its profile was published in 2015 and thousands of papers have been produced based on its data. However, in recent years there have been significant changes in this data source, with many new GP practices joining from Scotland, Wales, and Northern Ireland, and with most of the active practices in England leaving to join CPRD Aurum. These changes, affecting size, population coverage, representativeness, and data linkages, have not been documented yet and researchers using CPRD GOLD need revised information to design and conduct their studies properly. They also need an up-to-date, citable manuscript of CPRD GOLD for current and future research.
This study aims to provide up-to-date details and guidance on the content and usage of CPRD GOLD overall and by UK constituent country. Additionally, it also aims to produce a manuscript that researchers can cite to support their current and future research.
We will report the number and proportion of historical and currently contributing patients by age, sex, ethnicity per each UK constituent country. We will also report the number of historical and currently contributing practices and their changes over time per each UK constituent country. For currently contributing practices we will report the index of multiple deprivation and urban/rural classification and use them as a proxy of their patientsâ socioeconomic status. We will compare a range of health indicators of the current CPRD GOLD patients (i.e. asthma, diabetes, hypertension, heart disease, obesity, stroke and smoking status) to national data per each UK constituent country.
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A descriptive study testing new, proposed NICE (National Institute for Health and Care Excellence) indicators on cardiovascular disease (CVD) risk assessments in primary care using general practice data — Tsz Wing Vanessa Kam ...
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A descriptive study testing new, proposed NICE (National Institute for Health and Care Excellence) indicators on cardiovascular disease (CVD) risk assessments in primary care using general practice data
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-16
Organisations:
Tsz Wing Vanessa Kam - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Tsz Wing Vanessa Kam - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Jean Masanyero Bennie - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Prevalence of cardiovascular disease risk assessment; current smoking; obesity; hypertension; hypercholesterolaemia; type 2 diabetes; erectile dysfunction; serious mental illness; rheumatoid arthritis; systemic lupus erythematosus; atrial fibrillation; type 1 diabetes; cardiovascular disease; familial hypercholesterolemia; CKD stage 3a to 5; current lipid lowering therapy; cardiovascular disease risk assessment 10-year risk score of 20% or more; NHS Health Check
Description: Lay Summary
Conditions affecting the heart or blood vessels are collectively known as cardiovascular disease (CVD). Regular checks of a person's risk of cardiovascular disease using formal tools can help GPs find people at high risk early. These people can then be helped through lifestyle changes or medicines to reduce their chance of experiencing heart attacks, strokes and other events.
The National Institute for Health and Care Excellence (NICE) has developed three measures which help GPs measure whether the right people are getting regular checks for their CVD risk. This includes people of a certain age, people with other conditions like high blood sugar and people with changeable risk factors like smoking and obesity.
To see if these measures are workable, we aim to test them using the anonymised GP data in CPRD Aurum. We will get the number of people in an age group that have conditions or changeable risk factors that increase the risk of cardiovascular disease, then look back and see how many of them had a check for CVD risk from their GP in the past three or five years. These results will be brought to a committee of healthcare professionals and a layperson, alongside comments from a public consultation, to help them decide whether the measures should be published.
If published, the measures can be used by GPs and local health systems to measure and drive improvements to their services, ensuring people at high risk of CVD are found and helped earlier.
Technical SummaryRegular cardiovascular disease (CVD) risk assessments in primary care allows for early recognition of individuals at risk of first CVD events and enables timely interventions for primary prevention. The National Institute for Health and Care Excellence (NICE) is developing three indicators for general practice to measure routine conducting of CVD risk assessments in higher risk populations. These are: 1) The percentage of people aged 45 to 84 years who have a recorded CVD risk assessment score in the preceding 5 years; 2) The percentage of people aged 43 to 84 years with a modifiable risk factor or comorbidity who have a recorded CVD risk assessment score in the preceding 3 years; 3) The percentage of people aged 43 to 84 years with a modifiable risk factor who have a recorded CVD risk assessment score in the preceding 3 years. This analysis will assess the viability of these indicators using primary care data in CPRD Aurum.
The modifiable risk factors are current smoking, obesity, hypertension and hypercholesterolaemia. The comorbidities are type 2 diabetes, erectile dysfunction, serious mental illness, rheumatoid arthritis, systemic lupus erythematosus and atrial fibrillation. For all three indicators, people with type 1 diabetes, CVD, familial hypercholesterolaemia, chronic kidney disease stage 3a to 5, previous â¥20% 10-year CVD risk score and current lipid lowering therapy treatment will be excluded.
The analysis will determine the denominator â the number of registered patients on 31st March 2023 of the specified age, with the comorbidities or modifiable risk factors and no exclusion criteria. The number of them who received a CVD risk assessment with any tool in the past three or five years will form the numerator. The proportion and its 95% confidence interval will be calculated.
The results will inform the NICE indicator advisory committee's decision on publishing the indicators.
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Glucagon-like peptide 1 receptor agonists and the risk of thyroid cancer among patients with type 2 diabetes — Samy Suissa ...
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Glucagon-like peptide 1 receptor agonists and the risk of thyroid cancer among patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-17
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Karine Suissa - Collaborator - Brigham & Women's Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sally Lu - Collaborator - McGill UniversityOutcomes:
The primary outcome will be an incident diagnosis of thyroid cancer. It will be identified using the CPRD using Read and SNOMED-CT codes, and in the HES APC using ICD-10 codes (Appendix 1).
Description: Lay Summary
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are drugs commonly prescribed for the treatment of type 2 diabetes, a chronic condition marked by elevated blood glucose levels. Despite their favourable clinical effects, these drugs have been the subject of safety concerns since their introduction to the market, including concerns with thyroid cancer, a diseased marked by uncontrolled cell growth in the thyroid gland, the hormone-producing gland in the neck. These concerns were brought on by animal studies using rodent models that showed that exposure to GLP-1 RAs induced thyroid cancer formation. Given the biological differences between human and rodent thyroids, however, it is unclear if this effect seen in rodents can be applied to humans. To date, only two observational studies have investigated the potential association between GLP-1 RAs and thyroid cancer. However, these studies have methodological limitations and the relationship between these drugs and thyroid cancer remains unclear. Thus, the aim of this study is to assess the potential association between the use of GLP-1 RAs and the risk of thyroid cancer among patients with type 2 diabetes, using a large population-based cohort. This information will be important to better understand the safety profile of the GLP-1 RAs.
Technical SummaryThe objective of this study is to assess whether GLP-1 RAs is associated with an increased risk of thyroid cancer, compared to DPP-4 inhibitors, among patients with type 2 diabetes.
The primary analysis will be conducted with a new-user, active comparator cohort, which will consist of new users of GLP-1 RAs and new users of DPP-4 inhibitors. Cohort entry will be the date of the first prescription for a GLP-1 RA or DPP-4 inhibitor during the study period, whichever came first. Patients will be followed from cohort entry until an incident diagnosis of thyroid cancer, switch or add-on of one of the study drugs, death from any cause, end of registration with the general practice, or the end of the study period, whichever occurs first. A one-year lag period will be imposed, where thyroid cancer events occurring in the first year of follow-up will be censored as non-events.
In a secondary analysis, we will use the prevalent new-user design, which will allow us to capture all the GLP-1 RA users during the study. We will match new GLP-1 RA users to DPP-4 inhibitor users on time-conditional propensity scores in a 1:3 ratio. Patients who switched from a DPP-4 inhibitor to a GLP-1 RA will be matched to DPP-4 inhibitor users on duration of previous DPP-4 inhibitor use and propensity score. Patients in this cohort will be followed from cohort entry until an incident diagnosis of thyroid cancer, switch or add-on of a GLP-1 RA among DPP-4 inhibitor users, death from any cause, end of registration with the general practice, or the end of the study period, whichever occurs first. A one-year lag period will also be imposed.
Cox proportional hazards models will be fitted to estimate hazard ratios with 95% confidence intervals for thyroid cancer.
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Alport Syndrome Patient Insights using Real-World Evidence: Baseline Characterisation and Treatment Pathways of Patients with Alport Syndrome Across Geographies - Exploring a rare Disease in a multi-database retrospective Cohort Study — Katrin Manlik ...
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Alport Syndrome Patient Insights using Real-World Evidence: Baseline Characterisation and Treatment Pathways of Patients with Alport Syndrome Across Geographies - Exploring a rare Disease in a multi-database retrospective Cohort Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-16
Organisations:
Katrin Manlik - Chief Investigator - Bayer AG
Katrin Manlik - Corresponding Applicant - Bayer AG
David Vizcaya - Collaborator - Bayer AGOutcomes:
1) Mortality (All-cause mortality will be defined as death from any cause);
2) Onset of kidney failure (first occurrence of any of the following: ⥠2 eGFR (estimated glomerular filtration rate) measurements of < 15 mL/min/1.73 m2 separated by at least 90 days; dependence on dialysis, diagnosis of kidney failure; chronic kidney disease stage 5; kidney transplant);
3) Cardiovascular outcomes (acute coronary syndrome; stroke; new-onset congestive heart failure; new-onset atrial fibrillation)Description: Lay Summary
The present study aims to better understand Alport Syndrome (AS), a rare genetic disease that can lead to kidney failure, vision problems, and hearing loss. This is a retrospective observational study, adhering to ethical principles, meaning it collects and analyses existing data from routine clinical care. The study will rely on multiple data sources from four different countries, including the Clinical Practice Research Datalink datasets from the United Kingdom, to gather insights about patients with AS.
The main objective of the study is to describe patient characteristics including demographics (like age and gender) and comorbidities of patients with AS. The study will also collect information about how patients with AS are treated in a real-world setting, what clinical events patients experience and how much healthcare resources are used by these patients. It will also look into how the disease progresses. This will be done by examining estimated glomerular filtration rate trajectories over time, a routine measure of kidney function.
This study will provide new insights and understanding into the real-world journey of patients with AS to better inform patients, clinicians and healthcare providers.
Technical SummaryAlport syndrome (AS) is a rare and often undiagnosed hereditary genetic disease that usually manifests in early childhood and is characterised by mutations in the type IV collagen genes resulting in defective collagen production. As a result, patients may present with haematuria or progressive loss of kidney function leading to renal failure, as well as eye abnormalities and hearing loss. Without treatment, the disease is likely to progress to kidney failure in the early 20s and most likely before the age of 40. There is no cure for AS. Instead, standard treatment includes the use of angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) to delay the onset of kidney failure.
Contemporary real-world evidence for patients with AS is lacking. Therefore, the present study aims to generate a robust body of evidence to provide insight into the burden of disease for patients with AS.
The primary objective of the study is to describe baseline patient characteristics including demographics and comorbidities in patients identified with AS, using the first diagnosis of AS as index date. Secondary objectives are to describe treatment use at baseline, post-index treatment patterns, baseline and annual rate changes from baseline for renal function measures, calculate incidence rates for mortality, cardiovascular and renal failure outcomes, and examine the progression of AS using estimated glomerular filtration rate trajectories over time.
The objectives of this study will be addressed using an observational retrospective cohort study of routinely collected healthcare data from the United States, United Kingdom, Japan, and Finland mapped to the Observational Medical Outcomes Partnership (OMOP) common data model, including the Clinical Practice Research Datalink (CPRD) Aurum and Gold datasets.
This study will provide new insights and understanding of the real-world journey of patients with AS to better inform patients, clinicians and healthcare providers.
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Trends in incidence and mortality of pancreatic cancer and risk prediction from primary care records in England — Rosa Parisi ...
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Trends in incidence and mortality of pancreatic cancer and risk prediction from primary care records in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-29
Organisations:
Rosa Parisi - Chief Investigator - University of Manchester
Salwa Zghebi - Corresponding Applicant - University of Manchester
catharine Morgan - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Glen Martin - Collaborator - University of Manchester
Mairead Geraldine McNamara - Collaborator - University of Manchester
Martin Rutter - Collaborator - University of Manchester
Rathi Ravindrarajah - Collaborator - University of Manchester
Sam Merriel - Collaborator - University of ExeterOutcomes:
Incident and death by pancreatic cancer in England (2006 -2022) across various strata of interest: age, sex, social deprivation, ethnicity, and geographic region in England and rural/urban areas.
Description: Lay Summary
The pancreas is an organ in the body, which helps with food digestion and controlling blood sugar (glucose) levels. Patients with cancer of the pancreas generally have very poor outlook. Only 5 among 100 people with pancreatic cancer survive 5 years after it is found. In the UK, cancer of the pancreas is the tenth most common cancer. Each year, roughly 10,500 new cases occur and around 10,000 people die from it. National UK data on the trends of pancreatic cancer are nearly 10 years old and information on how it affects different groups of the population is limited. Unfortunately, there is no screening test for pancreatic cancer and tools for picking it up early arenât very good.
We will use anonymous data from general practice records in England, between 2006-2022, to find the number of people who either get pancreatic cancer or die from it. We will look at their age, sex, ethnicity, and how deprived or wealthy they are. We will also check how well tools from other studies for predicting the condition work by combining these tools. Finally, we will find out what kinds of people are more likely to get pancreatic cancer in the future.
The results of this study will provide the most up-to-date knowledge on the number of people with pancreatic cancer in England. We will learn more about which groups of people are more or less likely to develop pancreatic cancer. The findings will also help GPs spot cancer of the pancreas earlier.
Technical SummaryBackground
Pancreatic cancer (PC) is one of the most lethal cancers in adults. Nearly 460,000 people with PC were diagnosed worldwide in 2018 with 430,000 deaths. Cancer incidence and mortality rates vary widely. The most recent estimates on the trends of PC at UK national level are nearly 10 years old. Additionally, national-level information on the impact of health inequalities and/or ethnicity on PC incidence is scarce. PC has very poor survival with only 5% of people surviving 5 years after diagnosis. This is often due to late-stage diagnosis. There is currently no screening test for PC and early detection tools are lacking.Aims
Improve our understanding of the incidence and mortality of PC by socio-demographic factors in England and develop and validate new tools to predict the risk of PC in primary care.Methods
Using population-based and case-control study designs, eligible population will be people aged â¥18years without a prior history of PC between 2006-2022 in England. Outcomes include annual incidence and mortality rates of PC. Poisson regression models will be used to estimate incidence and mortality rates overall and by age, sex, ethnicity, social deprivation and whether they live in rural/urban areas. Using information from an existing systematic review, we will validate existing risk prediction models in linked primary, secondary data and mortality records and perform model ensemble and stack regression to combine risk factors from these models. Subsequently, using machine learning approaches (random forest, deep learning, gradient boosting), we will analyse the trajectories of the risk factors leading to the disease to develop and validate a new risk prediction model for PC.Expected impacts
Our study is expected to: a) update national statistics on PC epidemiology; b) provide insights in temporal trends, e.g. age of onset and ethnic differences in incidence; and c) improve the disease prediction.
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Feasibility study: identifying Dravet Syndrome and Lennox-Gastaut Syndrome from all epilepsies recorded in Clinical Practice DataLIink linked to Hospital Episodes Statistics datasets — Indraraj Umesh Doobaree ...
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Feasibility study: identifying Dravet Syndrome and Lennox-Gastaut Syndrome from all epilepsies recorded in Clinical Practice DataLIink linked to Hospital Episodes Statistics datasets
Datasets:GP data, CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register; CPRD GOLD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.Outcomes:
Seizures types, frequency and duration
Mortality (cause-specific, overall; number, and proportions)
Survival (feasibility of defining and estimating disease-free or progression-free, overall) Hospitalisation, outpatient visits and general practice consultation (cause-specific and overall)
Comorbidities, including cognitive dysfunction
Specialty caring for DS/LGS
Referal to neurological and social careBasic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained. Rates in person-time will be calculated wherever appropriate.
Description: Lay Summary
Epilepsy is a condition where the brain does not function properly and causes seizures. These makes the body move randomly and fast. In some cases, it can lead to breathing difficulties, loss of consciousness and even death. Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) are rare types of epilepsy that start during early childhood and can cause severe negative consequences, including developmental problems and premature death in some cases. Their carers are also impacted by poor quality of life and work restrictions. DS and LGS are often misdiagnosed leading to those affected receiving the wrong treatment. This feasibility study intends to find a method to identify with DS and LGS patients using their healthcare records from the Clinical Practice Research DataLink linked to the Hospital Episodes Statistics. This would require that patients with epilepsies are screened for the types of seizures that are related to DS and LGS, including when they started and ended, and their responses (including unresponsiveness) to treatments that were prescribed. The feasibility study will also assess what possible data are available from the general practitionersâ and the hospitalsâ records on complications, referral to neurological and social care as well as causes of hospitalisations and death. This information will be used to make decisions to conduct future research on DS and LGS to assist healthcare practitioners and service providers understand how many patients suffer from DS and LGS and to assess their response to treatment with a view to improve their care.
Technical SummaryDravet Syndrome (DS) and LennoxâGastaut syndrome (LGS) are rare epileptic encephalopathies which start in early childhood and continue into adulthood. Both syndromes are characterised as drug-resistant and are associated with cognitive dysfunction and poor quality of life. Carers of DS/LGS patients can also experience poor quality of life too and work restrictions. Misdiagnoses are not uncommon and can delay the correct treatment. The codes utilised within the Clinical Practice Research DataLink (CPRD) linked to the Hospital Episodes Statistics (HES) to record DS/LGS are inadequate to identify them, especially as patients can be misdiagnosed. Additional criteria, e.g. type of seizures (e.g. myoclonic), resistance to treatment, will also be used to identify DS/LGS. This feasibility study will aim to identify which criteria are required to enable their identification and will screen the CPRD and HES records (Inpatient, Outpatient and Accident & Emergency datasets) of epilepsy patients for the relevant fields that contains these criteria, which will then be used to construct separate algorithms to be used for future research. The feasibility study will also assess what data are available from the general practitionersâ and the hospitalsâ records on complications (inc. on Mother-Baby Link), referral to neurological and social care as well as causes of hospitalisations and death (from the ONS death registry). Data from this feasibility study will enable to the identification of DS and LGS patients (especially the latter which has heterogenous aetiology) for the conduct of future research will describe the epidemiology, health resource utilisation and cost burden of these epilepsies on the healthcare system in England as well as their impact on the sufferersâ quality of life. This data will be published in the public domain for healthcare practitioners and service providers to utilise in order to improve healthcare provision and treatment outcomes for patients with DS and LGS.
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Clinical Practice Research Datalink GOLD has changed: an updated overview of its content and characteristics to improve clinical research using this data source. — Antonella Delmestri ...
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Clinical Practice Research Datalink GOLD has changed: an updated overview of its content and characteristics to improve clinical research using this data source.
Datasets:GP data, Numbers and total years of follow-up of historical and current patients overall and per each UK constituent country, stratified by age, sex and ethnicity, will be reported. For current patients, also the socioeconomic status (measured by GP practice area level deprivation and urban/rural classification) will be investigated.
The number of current patients with a record of the following health indicators will be reported: asthma, diabetes, hypertension, heart disease, obesity, stroke and smoking status.Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-04
Organisations:
Antonella Delmestri - Chief Investigator - University of Oxford
Antonella Delmestri - Corresponding Applicant - University of Oxford
Eleanor Axson - Collaborator - CPRD
Maria Sanchez - Collaborator - University of Oxford
Sonia Coton - Collaborator - CPRDOutcomes:
Numbers and total years of follow-up of historical and current patients overall and per each UK constituent country, stratified by age, sex and ethnicity, will be reported. For current patients, also the socioeconomic status (measured by GP practice area level deprivation and urban/rural classification) will be investigated.
The number of current patients with a record of the following health indicators will be reported: asthma, diabetes, hypertension, heart disease, obesity, stroke and smoking status.Description: Lay Summary
Clinical Practice Research Datalink (CPRD) GOLD is a large and influential database of clinical practices from the United Kingdom (UK). CPRD GOLD has been used for decades in national and international medical research: its content and characteristics were published in 2015. However, in recent years there have been significant changes in this data source, with many new clinical practices joining from Scotland, Wales, and Northern Ireland, and with most of the active clinical practices in England leaving. These changes and their effects have not been documented yet and researchers using CPRD GOLD need revised information to design and conduct their studies appropriately.
Technical Summary
Without clear evidence, users of CPRD GOLD might design their studies incorrectly and misinterpret analyses results by using an out-of-date data resource profile as a reference. The lack of revised information might lead researchers to reach and publish the wrong conclusions, which could damage patientsâ lives by affecting public health policies, clinical care, and drug safety monitoring.
This study aims to provide these missing up-to-date details and guidance on the content and usage of CPRD GOLD, overall and by UK constituent country. Additionally, it also aims to produce a manuscript that researchers can use as a reference for their current and future research. This project will benefit patients in the UK indirectly by filling the current knowledge gap about CPRD GOLD, and enabling researchers to conduct their studies properly and influencing health decision making correctly.CPRD GOLD is a large, rich, and influential UK clinical practice database, which has been used for decades in national and international medical research. Its profile was published in 2015 and thousands of papers have been produced based on its data. However, in recent years there have been significant changes in this data source, with many new GP practices joining from Scotland, Wales, and Northern Ireland, and with most of the active practices in England leaving to join CPRD Aurum. These changes, affecting size, population coverage, representativeness, and data linkages, have not been documented yet and researchers using CPRD GOLD need revised information to design and conduct their studies properly. They also need an up-to-date, citable manuscript of CPRD GOLD for current and future research.
This study aims to provide up-to-date details and guidance on the content and usage of CPRD GOLD overall and by UK constituent country. Additionally, it also aims to produce a manuscript that researchers can cite to support their current and future research.
We will report the number and proportion of historical and currently contributing patients by age, sex, ethnicity per each UK constituent country. We will also report the number of historical and currently contributing practices and their changes over time per each UK constituent country. For currently contributing practices we will report the index of multiple deprivation and urban/rural classification and use them as a proxy of their patientsâ socioeconomic status. We will compare a range of health indicators of the current CPRD GOLD patients (i.e. asthma, diabetes, hypertension, heart disease, obesity, stroke and smoking status) to national data per each UK constituent country.
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Investigating whether a new NICE (National Institute for Health and Care Excellence) indicator on chronic obstructive pulmonary disease (COPD) annual reviews for those at high risk of hospital admission can be measured using general practice data — Jonathan Wray ...
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Investigating whether a new NICE (National Institute for Health and Care Excellence) indicator on chronic obstructive pulmonary disease (COPD) annual reviews for those at high risk of hospital admission can be measured using general practice data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-15
Organisations:
Jonathan Wray - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICEOutcomes:
Prevalence of COPD; current smoking status; COPD exacerbations; COPD review; forced expiratory volume (FEV1); Medical Research Council (MRC) Dyspnoea Scale; previous COPD-related hospital admissions; cancer diagnosis; coronary heart disease, atrial fibrillation; heart failure, learning disability; serious mental illness; frailty.
Description: Lay Summary
The National Institute for Health and Care Excellence (NICE) develops indicators to measure the quality of healthcare. This study aims to assess a proposed new NICE indicator for a long-term lung disease in which the lungs are damaged, making it harder for air to get in and out. This indicator will focus on care for people with this condition, called chronic obstructive pulmonary disease (COPD), who are at higher risk of being hospitalised.
The proposed indicator will measure the percentage of high-risk patients who have had a thorough review in the past year. This review should record how often the patient has had disease exacerbations (temporary flare-ups) and assess their breathlessness using a standard scale.
This study will use a database of UK medical records to look back at a group of COPD patients, selected using established methods. The study will describe which patients have factors putting them at higher risk of hospital admission, including previous admissions, other health conditions, and test results.
Researchers will then see how many high-risk patients have had the thorough review described in the past year. Results will be compared across deprivation levels in patientsâ areas, to see if there are inequalities in how well patient reviews are being done.
Publishing this NICE indicator should improve servicesâ approach to ensure that those at highest risk of hospital admission are encouraged to attend an annual COPD review to get the support they need to prevent their symptoms getting worse.
Technical SummaryThe National Institute for Health and Care Excellence (NICE) develops indicators to measure quality of care outcomes. The aim of the current study is to assess the measurability of a proposed NICE general practice indicator: âThe percentage of people with COPD at higher risk of hospital admission who have had a review in the preceding 12 months, including a record of the number of exacerbations and an assessment of breathlessness using the Medical Research Council dyspnoea scaleâ. This testing will help inform decisions about suitability for inclusion in the Quality and Outcomes Framework (an incentivised quality improvement scheme for general practices in England).
A retrospective observational cohort study will be conducted using CPRD Aurum primary care data linked to Hospital Episode Statistics Admitted Patient Care (HES APC). The COPD cohort will be defined according to the Quality and Outcomes Framework (QOF) business rules. From this population we will describe the number of people with modifiable risk factors, previous COPD-related hospital admissions, comorbidities, or assessment results that would put the patient at higher risk of hospital admission. We will then measure the proportion of high-risk individuals that had a COPD review in the previous 12 months, with a record of number of exacerbations and an assessment of breathlessness. Results will be stratified by patient-level Index of Multiple Deprivation (IMD) quintile to understand if the indicator reflects healthcare access inequalities.
Publication of this indicator will give service providers an understanding of whether their approach to annual COPD is inclusive of those at highest risk of hospital admission. This information will help them to develop their approach so that those at highest risk are encouraged to attend an annual review. This will ensure they get the support they need to prevent their COPD symptoms getting worse.
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Exploring clinical pathways in large-scale electronic healthcare record data: applying sequence analysis to pre-arthroplasty pathways in osteoarthritis — Dahai Yu ...
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Exploring clinical pathways in large-scale electronic healthcare record data: applying sequence analysis to pre-arthroplasty pathways in osteoarthritis
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-29
Organisations:
Dahai Yu - Chief Investigator - Keele University
Smitha Mathew - Corresponding Applicant - Keele University
Emma Parry - Collaborator - Keele University
George Peat - Collaborator - Keele University
James Bailey - Collaborator - Keele UniversityOutcomes:
Study 1
Prevalence of exposures at different time interval.Study 2
Distinct typologies of care patterns prior to primary total knee replacement.Study 3
Association of patientsâ characteristics with different typologies of care patterns and outcome will be the odds ratios and confidence intervals.Study 4
Comparison between trajectories of care strategies derived using latent class growth models and care patterns derived using sequence analysis.Description: Lay Summary
Many patients get knee replacement for osteoarthritis, but we don't know exactly what kind of medical care they receive leading up to it. Even though there are guidelines for different treatments, we don't know how people actually experience care â when they get it, and what kind of treatments they get.
To understand this, we will look at the medical records of people who have had a knee replacement. We will study what healthcare they received over the ten years prior to their joint replacement, including doctor visits, medicines they were prescribed, and other healthcare events. The goal is to simplify this information into easy-to-understand types of care patterns. Then, we will see which types of care patterns are more common in different groups of people, like older or younger patients, men or women, and those who are poorer or richer. This way, we hope to learn more about the early signs of knee problems and find out if there are differences in how people are taken care of.
Technical SummaryBackground:
Primary total knee replacement is the definitive and effective intervention for end-stage knee osteoarthritis. However, there is a need to enhance conservative care earlier in the condition. The NICE outlines a care pathway from diagnosis, encompassing self-management, non-surgical treatments (information, exercise, weight loss), and various nonpharmacological and pharmacological interventions before considering joint surgery. The actual paths patients take are unclear but likely to be complex, variable, and influenced by multiple factors. Understanding real-world healthcare utilisation patterns is essential for patients, healthcare professionals, and health service planners.
Aim:
Identify different care patterns before primary total knee replacement for osteoarthritis and explore variations and inequalities in these patterns.Objectives:
1. Derive various care pattern typologies through sequence analysis of retrospective care records of the above case series. Patients who had knee replacement surgeries will be identified using linked data from CPRD- Aurum and HES-APC data. Primary and secondary care strategies will be identified using linked data from CPRD-Aurum and HES-APC data.2. Explore the association between care pattern typologies and patient characteristics (e.g., age, sex, ethnicity, geographical region, body mass index, comorbidities, area-level deprivation, and lifestyle risk factors like smoking and drinking). Patientsâ socioeconomic characteristics will be identified using linked data from CPRD-Aurum and patient-level Index of Multiple Deprivation.
Methods
Study 1: A descriptive analysis will be applied to estimate the prevalence of each type of exposure in the ten years leading up to the index condition, using different time intervals (1, 3, 6 and 12-month time windows).
Study 2: Sequence analysis will be used to construct distinct typologies of care patterns.
Study 3: Multinomial regression analyses to test the association of each derived typology and patient characteristics.
Study 4: Examine trajectories of care strategies over time using latent class growth models and compare the results with sequence analysis results.
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Evaluating the relationship between pregnancy complications and health before and after pregnancy using electronic health record data in England — Jennifer Jardine ...
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Evaluating the relationship between pregnancy complications and health before and after pregnancy using electronic health record data in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-30
Organisations:
Jennifer Jardine - Chief Investigator - Queen Mary University of London
Jennifer Jardine - Corresponding Applicant - Queen Mary University of London
Rebecca Lissmann - Collaborator - Queen Mary University of London
Rohini Mathur - Collaborator - Queen Mary University of London
Stamatina Iliodromiti - Collaborator - Queen Mary University of LondonOutcomes:
(1) Pregnancy outcomes, including preterm birth, stillbirth, fetal growth restriction, mode of birth (caesarean, instrumental, spontaneous vaginal), and the development of specific complications in pregnancy (hypertensive disorders, gestational diabetes, intrahepatic cholestasis of pregnancy, antenatal and postnatal depression, peripartum psychosis).
(2) Maternal health outcomes after birth, including all-cause and specific-cause mortality, cardiovascular outcomes, diabetes, and mental health outcomes.Description: Lay Summary
Differences in healthcare based on ethnic and economic backgrounds have a substantial impact on women's health. We are not using what we know about pregnancy problems and how they link to future health issues enough to reduce these inequalities. For example, problems during pregnancy, like high blood pressure and diabetes, can lead to long-term heart and metabolic issues. Mental health during and after pregnancy can also affect future mental health.
To understand how women's health is affected by pregnancy, we want to use hospital records of women who have and have not given birth, linked to records before and after birth from primary and secondary care and mortality records.
We plan to use the data to understand what happens to women with pregnancy problems or complications in the months and years after giving birth. We'll use statistical tests and models to understand the relationship between health and complications in pregnancy and long-term health. Understanding these links and how they are influenced by womenâs characteristics, including their ethnic and socioeconomic group, will enable better identification of women at risk of future health problems. This can lead to better ways of helping women stay healthy through new clinical and policy interventions.
Technical SummaryTechnical summary (300 words)
Ethnic and socioeconomic disparities in healthcare disproportionately affect women's health. Currently, limited use is made of the knowledge that pregnancy complications have strong associations with long-term health outcomes. Areas in which links have been shown include gestational hypertension and long-term cardiovascular health; gestational diabetes and long-term metabolic health; perinatal mental health and subsequent mental health conditions. Understanding the interaction between pregnancy complications and socioeconomic diversity and their combined role in long-term health offers opportunities to improve risk assessment and potentially improve womenâs health across the life course.
In this study, we will assess the relationship between womenâs health before, during and after pregnancy using routine electronic health records. To do this, the study will address two overall objectives. First, we will develop and phenotype a study cohort of women in England who have and have not given birth. Hospital Episode Statistics (HES) admission data will be used to determine birth records for women and babies, including details about their birth and any complications; we will then link this to information before during and after pregnancy in primary (CPRD) and secondary (HES) care and mortality (ONS) records. We will comprehensively profile this cohort, including its representativeness and any risk of bias. Second, for women with pregnancy conditions (including hypertension, diabetes, and mental illness) and complications (such as preterm birth, fetal growth restriction, and stillbirth) and their babies, we will look at clinical precursors and ongoing morbidity after birth. We plan to explore these using simple tests of association, regression and survival analyses.
An understanding of these associations, and how they interact with other risk factors such as age and ethnicity, could underpin better and timely identification of women at risk of long-term poor health, and development of clinical and policy interventions to improve womenâs health.
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Target Trial Emulation of Chemoprevention of Barrett's Oesophagus: A Feasibility Study — Mie Thu Ko ...
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Target Trial Emulation of Chemoprevention of Barrett's Oesophagus: A Feasibility Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Mie Thu Ko - Chief Investigator - University of East Anglia
Mie Thu Ko - Corresponding Applicant - University of East Anglia
Allan Clark - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Leo Alexandre - Collaborator - University of East AngliaOutcomes:
Barrettâs oesophagus, oesophageal cancer, all-cause mortality.
Description: Lay Summary
Oesophageal adenocarcinoma (OAC) is known to be an aggressive cancer with very poor prognosis. Barrettâs oesophagus (BO), which refers to a change in the lining of the oesophagus as a complication of acid reflux, is the only known precursor to OAC. There is interest in the role of chemoprevention in this context - medications which may prevent malignant progression of BO. These candidate chemopreventive medications (CCMs), include acid-suppressive drugs called proton-pump-inhibitors (PPIs), aspirin and statins.
The most recent European medical guidelines have recommended the use of PPIs as chemoprevention in the management of BO. However, the evidence underpinning these recommendations is limited. Although previous research studies have suggested that use of these medications is associated with a reduced risk of OAC, most studies are at risk of bias leading to incorrect results.
We plan to carry out a future research study using English healthcare databases (including the clinical practice research datalink, CPRD) to see if CCMs are effective in patients with BO. We will use methods which reduce bias and are more likely to generate results which reflect the truth. To inform this future research we will conduct a feasibility study. This aims to calculate the number of patients with new diagnosis of BO, the number of prevalent users (prescriptions issued before diagnosis of BO) of each of these medications, the number of new users (incident users) after diagnosis of BO, the number of high versus low dose PPI users after diagnosis of BO, and overall progression rate to cancer.
Technical SummaryBarrettâs oesophagus (BO) is the precursor to oesophageal adenocarcinoma (OAC). There is clinical interest in chemoprevention (with proton pump inhibitors, aspirin and statins) to alter its natural history. Previous observational research has suggested significant reductions in the incidence of OAC in patients with BO among users of CCMs. However, most studies are at serious or critical risk of bias. Departure from the tenets of a randomised controlled trial when conducting observational research is likely a greater threat to validity than unmeasured confounding. The explicit alignment of the protocol for an observational study to that of the hypothetical âtargetâ trial can improve causal inference. Before proceeding to a target trial emulation study, we propose a feasibility study. The objectives are to:
1. Determine the number of eligible patients contributing to CPRD Aurum from 1990 diagnosed with BO
2. Determine the number of additional patients from 1990 diagnosed with BO in HES APC
3. Determine the overall annual incidence rate for progression to oesophageal cancer.
4. Determine the overall annual oesophageal cancer-free mortality rate.
5. Quantify the use of individual CCMs in patients with BO (separately for prevalent and new users).
6. Quantify the numbers of high and low dose new PPI users in patients with BO.
7. Undertake power calculations for each CCM comparison.The intended public health benefit of this feasibility study is to develop an understanding of how to optimally use routine data sources to determine and describe patients with BO, their medication use, and their overall annual rate of malignant progression. This data will inform a well-designed study to evaluate the effect of medications which may prevent malignant progression of BO.
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Multi-state model and Joint models of recurrent cardiovascular disease — Amand Schmidt ...
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Multi-state model and Joint models of recurrent cardiovascular disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-04
Organisations:
Amand Schmidt - Chief Investigator - University College London ( UCL )
Rikesh Bhatt - Corresponding Applicant - University College London ( UCL )Outcomes:
Primary outcome: time till MMVD occurrence.
Secondary outcome: occurrence of individual disease contributing the MMVD composite, recurance of MMVD, and all cause mortality.
Description: Lay Summary
If you have diabetes, you're more likely to face health problems like heart and blood vessel diseases. These issues can also affect other parts of your body, like your eyes, brain, and kidneys. Having diabetes puts you at risk of getting several diseases over your lifetime. This can lead to health complications, making life shorter and less enjoyable. This research project uses data from the Clinical Practice Research Datalink to learn about how diseases develop over time in people with diabetes. The goal is to find out what factors contribute to these health issues and create tools that can predict the risk of having multiple health problems. The findings would enable healthcare professionals to offer preventive care to patients with an elevated risk of developing these diseases and to determine the best time to start treatment.
Technical SummaryThe study aims to determine the extent to which risk factors correspond with the occurrence and timing of macro- and microvascular diseases (MMVD), encompassing the conditions cardiovascular disease (CVD), stroke, vascular dementia, peripheral arterial disease, abdominal aortic aneurysm, nephropathy, retinopathy, and microangiopathy. Of particular interest is MMVD in individuals with type 2 diabetes mellitus (T2DM), who face elevated risks. We seek to determine if these risk factors influence the progression of adverse T2DM outcomes. Initially, we will assess variables in QRISK3, a CVD risk algorithm. We will subsequently expand the list of variables beyond the QRISK3 predictors using the wealth of available EHR data.
Data sources:
Data will be drawn from hospital episode statistics (HES), primary care records, and Office for National Statistics (ONS) data. These sources will provide MMVD diagnoses, fatal events, patient demographics, prescriptions, and lifestyle factors.
The study design:
A cohort study comprising individuals aged 30 at enrollment without prior MMVD history, using data from 1998 to 2021. Participants will be followed until death, MMVD diagnosis, or loss to follow-up. Stratification based on T2DM diagnosis will reflect the MMVD burden among diabetic individuals.Proposed analyses:
Analyses will involve Cox regression and multi-state models (MSM) to predict MMVD risk, capturing transitions between health states and MMVD. The parameters of the models would estimated by maximising the likelihood function using a general purpose optimiser. MSMs will provide insight to the risk of progressing from a healthy state without MMVD, towards various disease onset, reccurance and death from other causes or MMVD. Ethnicity, sex, age, socioeconomic status, and diabetes will define subgroup indicators. Model performance will be assessed using an 80/20% split for training and testing, evaluating discrimination and calibration.
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Target Trial Emulation of Chemoprevention of Barrett's Oesophagus: A Feasibility Study — Mie Thu Ko ...
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Target Trial Emulation of Chemoprevention of Barrett's Oesophagus: A Feasibility Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Mie Thu Ko - Chief Investigator - University of East Anglia
Mie Thu Ko - Corresponding Applicant - University of East Anglia
Allan Clark - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Leo Alexandre - Collaborator - University of East AngliaOutcomes:
Barrettâs oesophagus, oesophageal cancer, all-cause mortality.
Description: Lay Summary
Oesophageal adenocarcinoma (OAC) is known to be an aggressive cancer with very poor prognosis. Barrettâs oesophagus (BO), which refers to a change in the lining of the oesophagus as a complication of acid reflux, is the only known precursor to OAC. There is interest in the role of chemoprevention in this context - medications which may prevent malignant progression of BO. These candidate chemopreventive medications (CCMs), include acid-suppressive drugs called proton-pump-inhibitors (PPIs), aspirin and statins.
The most recent European medical guidelines have recommended the use of PPIs as chemoprevention in the management of BO. However, the evidence underpinning these recommendations is limited. Although previous research studies have suggested that use of these medications is associated with a reduced risk of OAC, most studies are at risk of bias leading to incorrect results.
We plan to carry out a future research study using English healthcare databases (including the clinical practice research datalink, CPRD) to see if CCMs are effective in patients with BO. We will use methods which reduce bias and are more likely to generate results which reflect the truth. To inform this future research we will conduct a feasibility study. This aims to calculate the number of patients with new diagnosis of BO, the number of prevalent users (prescriptions issued before diagnosis of BO) of each of these medications, the number of new users (incident users) after diagnosis of BO, the number of high versus low dose PPI users after diagnosis of BO, and overall progression rate to cancer.
Technical SummaryBarrettâs oesophagus (BO) is the precursor to oesophageal adenocarcinoma (OAC). There is clinical interest in chemoprevention (with proton pump inhibitors, aspirin and statins) to alter its natural history. Previous observational research has suggested significant reductions in the incidence of OAC in patients with BO among users of CCMs. However, most studies are at serious or critical risk of bias. Departure from the tenets of a randomised controlled trial when conducting observational research is likely a greater threat to validity than unmeasured confounding. The explicit alignment of the protocol for an observational study to that of the hypothetical âtargetâ trial can improve causal inference. Before proceeding to a target trial emulation study, we propose a feasibility study. The objectives are to:
1. Determine the number of eligible patients contributing to CPRD Aurum from 1990 diagnosed with BO
2. Determine the number of additional patients from 1990 diagnosed with BO in HES APC
3. Determine the overall annual incidence rate for progression to oesophageal cancer.
4. Determine the overall annual oesophageal cancer-free mortality rate.
5. Quantify the use of individual CCMs in patients with BO (separately for prevalent and new users).
6. Quantify the numbers of high and low dose new PPI users in patients with BO.
7. Undertake power calculations for each CCM comparison.The intended public health benefit of this feasibility study is to develop an understanding of how to optimally use routine data sources to determine and describe patients with BO, their medication use, and their overall annual rate of malignant progression. This data will inform a well-designed study to evaluate the effect of medications which may prevent malignant progression of BO.
Source -
Feasibility study on hereditary angioedemia and its treatment with androgens — Indraraj Umesh Doobaree ...
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Feasibility study on hereditary angioedemia and its treatment with androgens
Datasets:GP data, CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register; CPRD GOLD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.Outcomes:
Age; sex; smoking history; alcohol consumption; Hypertensive diseases; ischaemic heart diseases; other forms of heart disease; cerebral infarction; acne; obesity; diabetes mellitus; hypercholesterolaemia; hyperlipidaemia; mental and behavioural disorders; benign neoplasm of the liver; other diseases of liver; disorders of thyroid gland
Mortality (cause-specific, overall; number, and proportions)
Survival (feasibility of defining and estimating disease-free or progression-free, overall)
Hospitalisation, outpatient visits and general practice consultation (cause-specific and overall)Description: Lay Summary
Hereditary angioedema (HAE) is a rare condition which causes recurrent swelling of parts of the body such as the tongue, throat, skin and gastrointestinal tract. Swelling attacks can be disabling and life-threatening. Treatments can be preventative to stop any attacks or given at the time of an actual attack. In the United Kingdom (UK), a particular medication known as androgen is commonly used as treatment but there is very limited scientific evidence available on how widely it is used in the care of HAE patients and what are their side effects (especially long-term), including development of male physical characteristics such as body hair in females), cardiac complications and growths in the liver. The aim of this feasibility study is to assess whether it is possible use the Clinical Practice Research DataLink (CPRD) database linked to the Hospital Episodes Statistics datasets (Inpatient, Outpatient and Accident & Emergency) to describe potential side effects associated with clinical management that included androgen against those that did not. The feasibility studies will determine how to accurately identify HAE patients using CPRD (AURUM and GOLD) and HES and assess completeness of androgen prescriptions and potential side effects. The potential length of follow up following use of androgen, including the duration of use, will be assessed to inform whether long-term side-effects can be described in a future study. The information that this study will provide assist clinicians and patients on choosing the best treatments and how to manage potential side-effects.
Technical SummaryHereditary angioedema (HAE) is a rare condition which causes recurrent swelling of the upper respiratory track, skin and gastrointestinal tract that can be disabling and life-threatening. Treatments can be prophylactic or on demand during angioedema attacks. Androgens have been used in HAE management but the treatment can lead to virilization and cardiac and liver complications. The aim of this feasibility study is to assess whether the Clinical Practice Research DataLink linked to Hospital Episodes Statistics datasets can be used to accurately identify HAE patients, including determining appropriateness of using ICD 10 code 84.1 for Defects in the complement system [C1 esterase inhibitor deficiency] in combination with care specialty code (for allergist/immunologist). It will also assess the completeness of androgens use (danazol and stanozolol) and other treatments (e.g. c1-esterase inhibitor both plasma derived and recombinant, tranexamic acid) as well as potential length of follow-up post androgen therapy for estimating long-term outcomes and adverse effects (from HES inpatient, outpatient, Accident & Emergency datasets, and Death Registry). This information will be used to plan a future retrospective cohort study to describe and compare the rate of adverse events and health resource utilisation for patient who received androgen therapy compared to those who did not. Adverse events of interest will include myocardial infarction, diabetes, renal disease, liver cancer, psychological disorders, thyroid disorders. Basic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained. Rates in person-time will be calculated wherever appropriate. Mitigation measures will be applied during analysis to suppress any finding on less than five patients to prevent any likelihood of their identification. The findings of this study on the beneficial and adverse effects of androgen will be disseminated in the public domain to assist clinicians and patients on their choice of best treatment strategies.
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Feasibility study on dengue infection requiring general practice and hospital care — Indraraj Umesh Doobaree ...
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Feasibility study on dengue infection requiring general practice and hospital care
Datasets:GP data, CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register; CPRD GOLD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.Outcomes:
This feasibility study will assess the possibility of identifying several demographic and clinical characteristics (described below in section D, which will assist with the planning of studies). In addition, the following outcome measures will be determined as part of the feasibility study:
⢠Mortality (cause-specific, overall; number, and proportions)
⢠Survival (feasibility of defining and estimating disease-free or progression-free, overall)
⢠Hospitalisation, outpatient visits and general practice consultation (cause-specific and overall)
⢠Pregnancy and birth among dengue patientsDescription: Lay Summary
Dengue is a mosquito-borne infection which is carried to humans by mosquito bites in certain parts of Asia, Africa, South America and Southern Europe. Many travellers returning from these regions to the United Kingdom (UK) have been infected with Dengue. Some develop severe symptoms, such as high-grade fever and bleeding, which require admission to hospital for treatment. There is limited information about dengue patients utilising the healthcare services in the UK. This feasibility study seek to understand if the Clinical Practice Research DataLink data sources called AURUM and GOLD and the Hospital Episodes Statistics datasets can be utilised to assess how many people present with dengue in the UK and what types of symptoms that they suffer from as well as how they are cared for while in hospital, including their cost. Therefore, this feasibility study will check what potential outcomes they may have in terms of symptoms and utilisation of healthcare resources as well as mortality; the quality and completeness of this data will be assessed. All this information will inform whether it will be possible to conduct a study with good quality on dengue using CPRD and HES data sources and the findings will be used to inform health professionals and providers about the impact of dengue on patients and the health care system, especially developing preventative measures and the planning of adequate care for dengue in the UK.
Technical SummaryDengue is transmitted to humans through mosquito bites in endemic regions of Asia, Africa, South America and Southern Europe. Many travellers returning from these regions to the United Kingdom (UK) have been infected with Dengue. Some develop severe symptoms, such as high-grade fever and haemorrhages, requiring admission to hospital. Diagnosis codes and general practice codes (ICD 10 in Hospital Episodes Statistics (HES) and medcodes or READ codes in Clinical Practice Research DataLink (CPRD) AURUM or GOLD) for dengue will be used to identify patients. HES datasets will be required because they contain admitted, outpatient and emergency care data for potentially severe dengue. The sample sizes for dengue patients (in primary and secondary care) will be obtained, including for subgroups of interest, which would be potential inclusion criteria (e.g. elderly) for future research on dengue. Historical data on dengue is important as recurrent infection can be more severe. Therefore, data from the earliest possible time on CPRD and HES datasets will therefore be required, as well as for assessing the distribution of risk factors (e.g. comorbidities or symptoms) on outcomes (e.g. mortality). Data quality and completeness for key variables will be assessed. The possibility to define cause-specific hospitalisation, outpatient visits and general practice consultations will also be assessed. Basic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained. Rates in person-time will be calculated wherever appropriate. This feasibility study will use this data to assess the potential of conducting good quality research on dengue using CPRD and HES data sources, which will be planned to generate evidence to inform health professionals and providers about the impact of dengue on patients and the healthcare system, with an aim to developing preventative measures and for the planning of adequate care for dengue in the UK.
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The prevalence, incidence, and mortality of Primary Raynaud's Phenomenon in England, United Kingdom. — Fiona Pearce ...
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The prevalence, incidence, and mortality of Primary Raynaud's Phenomenon in England, United Kingdom.
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-15
Organisations:
Fiona Pearce - Chief Investigator - University of Nottingham
Anthony Chen - Corresponding Applicant - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Peter Lanyon - Collaborator - Nottingham University Hospitals
Stephanie Lax - Collaborator - University of NottinghamOutcomes:
There are three main outcomes to be measured annually â (1) Prevalence; (2) Incidence; (3) Mortality (all-cause mortality and cause-specific mortality).
The data will be linked with ONS data for all-cause and cause-specific information.
Description: Lay Summary
Primary Raynaudâs Phenomenon is a condition impacting the blood flow around the body, often causing colour changes in areas like the fingers and toes. It typically occurs when a person is either cold, anxious, or stressed and can impact anyone. Primary Raynaudâs Phenomenon accounts for 80-90% of Raynaudâs cases and is more common among women and minority ethnic groups. The typical age of onset ranges from 15-30. It is a condition that develops by itself and can lead to pain and discomfort impacting oneâs quality of life. Currently, to our knowledge, there are no detailed up-to-date studies addressing the prevalence (total number of cases at a given time), incidence (number of new cases per year), and mortality (number of deaths) of Primary Raynaudâs Phenomenon in England, United Kingdom.
Therefore, the aim of the proposed study is to determine the prevalence, incidence, and mortality of Primary Raynaudâs Phenomenon in the population of England, UK. Cases of Primary Raynaudâs Phenomenon will be identified using electronic medical records from the Clinical Practice Research Datalink (CPRD). Results will be presented by age, sex, ethnicity, socio-economic status, and geography. This studyâs findings will provide evidence for the management of Primary Raynaudâs Phenomenon in the population and will help improve patient and public health.
Technical SummaryPrimary Raynaudâs Phenomenon is a condition that affects blood circulation. It is more common among the female population and minority ethnic groups. In the English population, data on prevalence, incidence, and mortality on Raynaudâs remains disparate and fragmented. This study aims to examine the prevalence, incidence, and mortality of Primary Raynaudâs Phenomenon in England, UK from 1998-2023. We will report the rates stratified by age, sex, ethnicity, socio-economic status (quintile of the Index of Multiple Deprivation) and geography (local constituents of England).
Cases of Primary Raynaudâs Phenomenon will be identified through read codes in CPRD (those who have Raynaudâs [total] excluding those who have secondary Raynaudâs i.e., myositisâ¦). The annual prevalence of Primary Raynaudâs Phenomenon will be calculated for all patients in the CPRD database meeting the definition for Primary Raynaudâs Phenomenon on 1st January each year divided by the denominator of all patients contributing data to the CPRD on 1st January each year multiplied by 100,000. The annual incidence of Primary Raynaudâs Phenomenon will be calculated using the number of new cases according to our definition of Primary Raynaudâs Phenomenon, divided by the total person-time of follow-up (denominator) multiplied by 100,000. Mortality will be (ascertained date of death recorded in the ONS mortality). Cause of death (recorded in ONS as an ICD-10 code) will be categorised into the leading causes of death: Dementia and Alzheimer's disease, ischaemic heart diseases, Chronic lower respiratory diseases, cerebrovascular diseases, Malignant neoplasm of trachea, bronchus and lung, other malignancies, and other causes following the ONS death summary statistics methodology (1).
These results will provide new knowledge which will inform updates to clinical guidelines and commissioning of health services, resulting in improvements in the health for people with Primary Raynaudâs Phenomenon.
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Real-world use and effectiveness of COVID-19 vaccines in pregnant women — Theresa Burkard ...
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Real-world use and effectiveness of COVID-19 vaccines in pregnant women
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-29
Organisations:
Theresa Burkard - Chief Investigator - University of Oxford
Theresa Burkard - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Nuria Mercade Besora - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
In the first study, the measured outcome is SARS-Cov-2 vaccination.
In the second study, the measured outcomes are a diagnosis of COVID-19 or a SARS-Cov-2 positive test result.Description: Lay Summary
This study focuses on two main aspects related to the COVID-19 vaccine. Firstly, we want to understand among pregnant women how many people are getting vaccinated and when they're getting vaccinated (before or during pregnancy). Secondly, we're assessing how well the vaccine works, which means whether it can reduce COVID-19 among vaccinated pregnant women. We're specifically looking at vaccines that have been commonly recommended for pregnant women.
Technical Summary
The results of this research will be important for pregnant women who are a particularly vulnerable population. It will help them to know whether vaccination against COVID-19 helps to reduce COVID-19. Furthermore, this research sheds light on the use of the COVID-19 vaccine within pregnant women and those who want to become pregnant. This will be important information for people in charge of decision making on promoting COVID-19 vaccination amongst pregnant women for example, in case the use is low and the vaccine is working well.Two objectives concerning the SARS-Cov-2 vaccine among pregnant women are pursued. First, to estimate vaccine uptake among pregnant women, and second, to assess vaccine effectiveness as to how well the vaccine reduces infection. All studies will be conducted in pregnant women who are identified using the Matcho. et al. pregnancy algorithm validated in CPRD data mapped to OMOP. The study period will last from the start of the UK SARS-Cov-2 vaccination period on December 8 2020 until January 2023. The study assesses only vaccines recommended during pregnancy (m-RNA based vaccines) as exposure. For the first objective, there will be two studies. First, we will estimate proportions of vaccination use that has happened before pregnancy and, second, that that has happened during pregnancy. For the second objective, there will be two studies as well, one study comparing vaccination to vaccine-naive pregnant women and a second study comparing the booster vaccine compared to the primary vaccination scheme. For both studies, we will perform 1:1 propensity score matching of pregnant women for every week of the study period. Every woman contribute a maximum of one episode each as an exposed and an unexposed pregnant woman. We will follow all women from the vaccination date (first study) and the booster date (second study) - and the same date in the matched control - until the earliest of the outcome, end of pregnancy, end of records or end of study period. We will estimate hazard ration of COVID-19 in exposed compared to unexposed using Cox proportional hazard regression analyses. Vaccine effectiveness / booster effectiveness estimates will be empirically calibrated based on negative control outcome results. When feasible, results will be stratified by trimester of pregnancy and vaccine brand.
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Incidence, prevalence and clinical consequences of bronchiectasis — Jennifer Quint ...
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Incidence, prevalence and clinical consequences of bronchiectasis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-30
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College London
Leah Deshler - Collaborator - Imperial College LondonOutcomes:
⢠incidence and prevalence of bronchiectasis
⢠rates of exacerbations
⢠incidence of cardiovascular disease, lung cancer, anxiety, depression
⢠mortality ratesDescription: Lay Summary
Bronchiectasis is a chronic lung condition characterised by symptoms of cough productive of sputum (including coughing up blood), breathlessness and recurrent chest infections which sometimes require prolonged courses of antibiotics or even hospital admission. Previous studies have investigated bronchiectasis using routine data in the UK, but it is not currently known how common bronchiectasis is in England, or the health burden of the disease with respect to hospitalisations or development of other co-morbidities. We know that it is a disease that is often associated with other conditions, but we do not know what the impact of having these other conditions is on bronchiectasis. We will therefore also explore the health burden of the disease with respect to hospitalisations or development of other diseases (e.g. cardiovascular disease) in people who have bronchiectasis in addition to other chronic diseases such as asthma, chronic obstructive pulmonary disease and autoimmune diseases.
This work will tell us how common bronchiectasis is in England and how common other diseases are in people with Bronchiectasis and how commonly occurring other conditions in addition to bronchiectasis affect the prognosis and natural history of bronchiectasis. We will measure incidence, prevalence, mortality and co-morbidity incidence overall and by the specific subgroups. We will explore this using linked primary and secondary care data. This will help us to better understand how common the disease is now, and who is potentially at risk of more severe disease. It will also help healthcare professionals know who may be at risk of severe disease.
Technical SummaryBronchiectasis is a chronic lung condition characterised by symptoms of cough productive of sputum (including coughing up blood), breathlessness and recurrent chest infections which sometimes require prolonged courses of antibiotics or even hospital admission. Whilst previous studies have investigated incidence and prevalence of bronchiectasis using CPRD data, these are now out of date. There are also limited studies exploring the natural history of bronchiectasis with respect to other chronic commonly co-occurring conditions.
We aim to provide up to date incidence and prevalence figures over the last 5 years as well as describing the healthcare burden in this population by exploring rates of bronchiectasis exacerbations (defined in primary care or by hospital admission) and the incidence of commonly occurring co-morbidities (e.g. cardiovascular disease) and how these differ by underlying exacerbation frequency. Among subgroups of people with bronchiectasis (those with co-morbid chronic obstructive pulmonary disease ((COPD), asthma or autoimmune disorders) we will also explore exacerbations and commonly occurring co-morbidities and compare the occurrence of these in people with bronchiectasis alone or asthma or COPD alone. This will include rates of exacerbation (inpatient and GP), outpatient management and mortality. We will use CPRD Aurum linked with HES APC, OP, IMD and ONS mortality data. We will use descriptive statistics, calculate incidence and prevalence and use negative binomial or Poisson regression to explore exacerbation rates. This information will help to inform disease burden and healthcare planning.
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Feasibility study on dengue infection requiring general practice and hospital care — Indraraj Umesh Doobaree ...
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Feasibility study on dengue infection requiring general practice and hospital care
Datasets:GP data, CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register; CPRD GOLD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-10
Organisations:
Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.Outcomes:
This feasibility study will assess the possibility of identifying several demographic and clinical characteristics (described below in section D, which will assist with the planning of studies). In addition, the following outcome measures will be determined as part of the feasibility study:
⢠Mortality (cause-specific, overall; number, and proportions)
⢠Survival (feasibility of defining and estimating disease-free or progression-free, overall)
⢠Hospitalisation, outpatient visits and general practice consultation (cause-specific and overall)
⢠Pregnancy and birth among dengue patientsDescription: Lay Summary
Dengue is a mosquito-borne infection which is carried to humans by mosquito bites in certain parts of Asia, Africa, South America and Southern Europe. Many travellers returning from these regions to the United Kingdom (UK) have been infected with Dengue. Some develop severe symptoms, such as high-grade fever and bleeding, which require admission to hospital for treatment. There is limited information about dengue patients utilising the healthcare services in the UK. This feasibility study seek to understand if the Clinical Practice Research DataLink data sources called AURUM and GOLD and the Hospital Episodes Statistics datasets can be utilised to assess how many people present with dengue in the UK and what types of symptoms that they suffer from as well as how they are cared for while in hospital, including their cost. Therefore, this feasibility study will check what potential outcomes they may have in terms of symptoms and utilisation of healthcare resources as well as mortality; the quality and completeness of this data will be assessed. All this information will inform whether it will be possible to conduct a study with good quality on dengue using CPRD and HES data sources and the findings will be used to inform health professionals and providers about the impact of dengue on patients and the health care system, especially developing preventative measures and the planning of adequate care for dengue in the UK.
Technical SummaryDengue is transmitted to humans through mosquito bites in endemic regions of Asia, Africa, South America and Southern Europe. Many travellers returning from these regions to the United Kingdom (UK) have been infected with Dengue. Some develop severe symptoms, such as high-grade fever and haemorrhages, requiring admission to hospital. Diagnosis codes and general practice codes (ICD 10 in Hospital Episodes Statistics (HES) and medcodes or READ codes in Clinical Practice Research DataLink (CPRD) AURUM or GOLD) for dengue will be used to identify patients. HES datasets will be required because they contain admitted, outpatient and emergency care data for potentially severe dengue. The sample sizes for dengue patients (in primary and secondary care) will be obtained, including for subgroups of interest, which would be potential inclusion criteria (e.g. elderly) for future research on dengue. Historical data on dengue is important as recurrent infection can be more severe. Therefore, data from the earliest possible time on CPRD and HES datasets will therefore be required, as well as for assessing the distribution of risk factors (e.g. comorbidities or symptoms) on outcomes (e.g. mortality). Data quality and completeness for key variables will be assessed. The possibility to define cause-specific hospitalisation, outpatient visits and general practice consultations will also be assessed. Basic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained. Rates in person-time will be calculated wherever appropriate. This feasibility study will use this data to assess the potential of conducting good quality research on dengue using CPRD and HES data sources, which will be planned to generate evidence to inform health professionals and providers about the impact of dengue on patients and the healthcare system, with an aim to developing preventative measures and for the planning of adequate care for dengue in the UK.
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Age- and disease-specific health system costs: a retrospective analysis of the average age and disease costs of care in England — Philip Clarke ...
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Age- and disease-specific health system costs: a retrospective analysis of the average age and disease costs of care in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-25
Organisations:
Philip Clarke - Chief Investigator - University of Oxford
Rhys Thomas - Corresponding Applicant - University of Oxford
Sophie Cole - Collaborator - Nuffield Department of Population HealthOutcomes:
The outcome in our models will be the individual-level healthcare costs per year. This outcome will be calculated by summing the costs of all prescriptions, procedures, and consultations an individual had in each study year. Costs of prescriptions will be calculated using the CPRD Aurum âestimated cost to the NHS variableâ. Costs for consultations and procedures will be calculated using the NHS National Cost Collection (NHS England, n.d.). Therefore, each observation will be the total cost of all consultations and treatments for that patient in that year.
Our parameter of interest will be the age- and disease-specific costs average of healthcare. These will be estimated using multivariate regressions, using individual-level healthcare costs per year as the dependent variable, and age and disease indicator variables (in separate regressions) as the independent variables. Further details of the analysis are presented in section âData/ Statistical Analysisâ.
Description: Lay Summary
Many organisations use age-standardised measures of health and healthcare âsuch as mortality ratesâto enable a more equitable evaluation of health outcomes across diverse populations. However, these same organisation report healthcare expenditures which have not been age-adjusted. Raw healthcare expenditures are a useful measure for comparing healthcare systems overall but are limited because they do not consider the vast differences in demographic structures and disease burden.
The aims of this study is to sepertaely estimate the average healthcare expenditures for a number of conditions, and the the average healthcare expenditures for each age group in English healthcare. Our work will estimate the average yearly cost of healthcare for a broad range of diseasesâa disease-specific cost of healthcare âand estimate an age-group average cost of healthcare â the age-specific cost of healthcare. The purpose of this work is to construct age- and disease-standardised healthcare expenditures which can be used to compare healthcare expenditures in England over time, and to compare Englandâs healthcare expenditures with other healthcare systems, while accounting for the differences in demographic structures and disease burden. This work is also vital for informing NHS planning of services and the allocation of healthcare funding, as it will allow us to predict future healthcare expenditures by combining our results with demographic and disease burden forecasts.
Technical SummaryThe specific aims of this study are to:
1) Estimate the average yearly healthcare costs of care for a broad range of individual diseases.
2) Estimate whether the cost of multimorbidity is greater to or less than the additive effect of these diseases separately.
3) Estimate the average yearly healthcare costs for each age group.
4) Analyse the changes in these costs over time, taking into account the changes in demography and disease burden.
5) Use the age-specific costs of care to calculate an age-standardised healthcare expenditure measure to compare expenditures in England with comparable countries.We will use individual healthcare utilisation data from the CPRD and HES and combine that with NHS costings data to calculate an individual-level total yearly cost of healthcare. To estimate the age- and disease-specific costs we will estimate a regression for each study sample year using the individual-level total cost of healthcare as an outcome, and either age categories, or disease categories as the dependent variables. To assess the cost of multimorbidity, we will interact disease with one another in the disease cost regressions and assess whether the joint cost of care of two conditions is greater or less than the additive cost of the diseases separately. In the final stages of analysis, we will use our age-specific healthcare expenditures and demographic composition, or disease prevalence, of comparable countries to compare the performance of the English healthcare system with comparable countries.
These results are not only important academically, but will also be used to forecast healthcare expenditures in England. Using the age- or disease-specific healthcare costs, and forecasts of future demographic or disease burdens, we are able to predict the likely future cost of healthcare for England, which is necessary for adequate planning and resource allocation in a budget constrained NHS system.
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Risk of Atherosclerotic Cardiovascular Disease in Early Type 2 Diabetes: A Retrospective Study Using CPRD Aurum Data — Esther Zimmermann ...
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Risk of Atherosclerotic Cardiovascular Disease in Early Type 2 Diabetes: A Retrospective Study Using CPRD Aurum Data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-18
Organisations:
Esther Zimmermann - Chief Investigator - Novo Nordisk A/S
Christian Kruse - Corresponding Applicant - Novo Nordisk A/S
Anders Boeck Jensen - Collaborator - Novo Nordisk A/S
John Wilding - Collaborator - University of Liverpool
Kamlesh Khunti - Collaborator - University of Leicester
Manjunatha Revanna - Collaborator - Novo Nordisk A/S
Stephen Bain - Collaborator - Swansea UniversityOutcomes:
Outcomes to be Measured
Primary Outcome:
10-year ASCVD Risk Estimator Plus and QRISK®3 engine risk in the entire patient populationASCVD Risk Estimator Plus Key Variables:
- Age
- Sex (Male/Female)
- Race (White / African-American / Other)
- Smoking status (Current / Former / Never)
- Diabetes status (Yes / No) (is a variable in the ASCVD Risk Estimator Plus. All patients included will be diagnosed with type 2 diabetes)
- Total Cholesterol (mmol/L)
- HDL (mg/dL)
- LDL (mg/dL)
- Systolic blood pressure (mmHg)
- Diastolic blood pressure (mmHg)
- Hypertension treatment (Yes/No)
- Statin treatment (Yes/No)
- Aspirin treatment (Yes/No)QRISK®3 Key Variables:
- Age
- Sex (Male/Female)
- Ethnicity
- Smoking status
- Diabetes 1 or 2 (included verbatim per QRISK®3 definition, while study population is solely T2D)
- Family history angina or heart attack
- Chronic Kidney Disease Stages 3, 4, or 5
- Atrial fibrillation
- Hypertension treatment (Yes/No)
- Migraines
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Schizophrenia, bipolar disorder or moderate/severe depression
- Atypical antipsychotic medication
- Steroid tablets
- Diagnosis of or treatment for erectile disfunction
- Cholesterol/HDL ratio
- Systolic blood pressure (mmHg)
- Standard deviation of at least two most recent systolic blood pressure readings (mmHg)
- Height (cm)
- Weight (kg/lbs)Description: Lay Summary
Atherosclerotic cardiovascular disease (ASCVD) is a condition where fat deposits build up in the body's blood vessels, leading to heart attacks and blood clots in the brain, a condition called a stroke. ASCVD is more common in people with type 2 diabetes (T2D), a condition that leads to difficulties in managing blood sugar levels, leading to an increased life-time risk of heart attacks and strokes compared to the general population.
Website-based computer programs exist that include several factors such as age, sex, blood pressure, and smoking status to calculate the chances that the person will experience a heart attack or stroke over the next 10 years. These programs can support healthcare professionals (HCPs) and patients in making further treatment decisions, including changes in lifestyle factors and use of medications.
Our research will investigate how great a risk of heart attack and stroke people with T2D have when they just start or are early in their treatment to lower their blood sugar levels. We will also investigate the risk associated with specific groups of patients, such as those with a high body weight. This can identify people who are at especially high risk and may benefit from earlier, more intensive treatment of their T2D.
Early intervention in people with T2D is essential to prevent the development of ASCVD. Our findings will provide important insights into the cardiovascular risks in subgroups of people with T2D, enabling improved treatment management and may ultimately reduce their burden of ASCVD.
Technical SummaryThis retrospective study will use CPRD Aurum data to estimate the 10-year ASCVD risk in type 2 diabetes patients at the time of prescription of 1st and 2nd line therapy for hyperglycaemia. The purpose of this study is to understand the unmet needs of these individuals in terms of cardiovascular disease prevention. The primary exposures will be predictors in the ASCVD Risk Estimator Plus and QRISK3 engines, including age, sex, race, cholesterol levels, blood pressure, diabetes, and smoking status. Both engines are based on Cox proportional hazards models where parameters and source code are publicly available. From the models and the covariate information, cumulative hazard can be calculated and translated into probability of ASCVD occurring during the 10 year timeframe. The risks will be calculated in all patients, and investigated in specific subgroups such as those with high BMI, specific age and deprivation groups, or comorbidities such as chronic kidney disease. The statistical methods will involve descriptive statistics of the distributions of probabilities in the various groups. In the event of missing data, multiple imputation will be applied to find a median imputed value for each covariate for each patient, in order to obtain a complete case dataset. The intended public health benefit of this research is to increase understanding of the unmet need for this patient group in terms of intervening early to prevent cardiovascular disease, which is a major cause of morbidity and mortality in these patients.
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Analysing trends in primary care diagnoses of chlamydia and chlamydia-related sequelae in young people — Katherine Soldan ...
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Analysing trends in primary care diagnoses of chlamydia and chlamydia-related sequelae in young people
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-25
Organisations:
Katherine Soldan - Chief Investigator - UK Health Security Agency (UKHSA)
Jessica Edney - Corresponding Applicant - UK Health Security Agency (UKHSA)
Grahame Davis - Collaborator - UK Health Security Agency (UKHSA)
Miranda Ferguson - Collaborator - UK Health Security Agency (UKHSA)Outcomes:
Number and rate (per 100,000 person-years) of diagnoses of: Chlamydia; Pelvic-inflammatory disease (PID); Epididymitis; Ectopic pregnancy (EP); Tubal factor infertility (TFI)
Description: Lay Summary
The National Chlamydia Screening Programme (NCSP) offers free chlamydia testing to all young women (including trans and non-binary people assigned female at birth) aged 15-24 years old in England. By diagnosing and treating more chlamydia infections, the NCSP aims to prevent complications from untreated chlamydia in young women. Complications can include persistent infections of the womb, fallopian tubes (tubes connecting ovaries to the womb), or ovaries; pregnancy in the fallopian tube; and infertility. Men (and trans and non-binary people assigned male at birth) with untreated chlamydia can sometimes experience epididymitis (persistent infection in the testicles). To evaluate the success of the NCSP, we need to know how many young people are being diagnosed with conditions associated with untreated chlamydia each year. This study will use CPRD Aurum data to monitor age-specific rates of conditions linked to untreated chlamydia infection between 2010 and 2023. This will allow us to see if diagnoses of these conditions among young women have been increasing, decreasing, or staying the same during this period, and will help us to characterise groups of people most likely to experience complications from chlamydia. We will also look at diagnoses of chlamydia-associated epididymitis in young men to monitor any potential negative impacts of a recent change in NCSP policy to focus on testing young women only. These insights will inform the evaluation and improvement of the NCSP, benefiting those most at risk of chlamydia and associated complications.
Technical SummaryThe National Chlamydia Screening Programme (NCSP) offers free asymptomatic chlamydia screening to all young women (including trans and non-binary people assigned female at birth) aged 15-24 years old in England. The NCSP aims to prevent sequelae from untreated chlamydia in young women including pelvic inflammatory disease, ectopic pregnancy, and tubal factor infertility. Untreated chlamydia in men (and trans and non-binary people assigned male at birth) can sometimes lead to epididymitis.
This study will focus upon 15- to 44-year-olds resident in England between 2010 and 2023. It will use CPRD Aurum data to determine trends in chlamydia and chlamydia-associated sequelae diagnoses within CPRD clinics. Read codes that denote primary or non-primary diagnosis of chlamydia and/or acute or chronic PID/EP/TFI/epididymitis will be used to include patients within CPRD Aurum. HES data will provide further information on patient admissions and outpatient care related to the outcomes of interest. Diagnoses recorded in HES will be selected using international classification of diseases (ICD-10) codes.
Diagnoses of the outcomes of interest will be presented as total numbers and diagnosis rates per 100,000 person-years for GP settings and diagnosis rates per 100,000 population for hospital inpatient episodes. This study may contribute to the evaluation of the NCSP against its aim of reducing the burden of chlamydia-associated sequelae in women and identify any inequities between ethnic and socio-economic groups. We will also look at diagnoses of chlamydia-associated epididymitis in young men to monitor any potential negative impacts of the recommendation to screen young women only.
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Associations between lisinopril and amlodipine use and risk of aneurysmal subarachnoid haemorrhage: A UK population-based cohort study — Shahab Abtahi ...
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Associations between lisinopril and amlodipine use and risk of aneurysmal subarachnoid haemorrhage: A UK population-based cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-29
Organisations:
Shahab Abtahi - Chief Investigator - Utrecht University
Shahab Abtahi - Corresponding Applicant - Utrecht University
Jos Kanning - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Ynte Ruigrok - Collaborator - University Medical Centre UtrechtOutcomes:
A new occurrence of aneurysmal subarachnoid haemorrhage (aSAH) during the study period (2004-2022) among patients with a recent hypertension diagnosis.
Description: Lay Summary
Aneurysmal subarachnoid haemorrhage (aSAH) is a rare type of stroke that has a high death rate and burden on patients. There is currently no drug treatment to prevent aSAH, and the only available treatment option is surgery. A recent study that investigated the SAIL databank in Wales found that using the blood pressure medicines lisinopril and amlodipine may reduce the chance of developing aSAH. However, it is unclear whether these drugs manage high blood pressure (a known aSAH risk factor) or have direct effects on blood vessels and the prevention of aSAH.
In this study, we intend to further investigate this association by directly comparing the effects of lisinopril and amlodipine to other similar blood pressure medicines (from the same drug class) to see whether they genuinely lower the occurrence of aSAH. We will use established methods to investigate the timing and effects of different daily doses and duration of use.
By answering our research question, we will have a better knowledge of how lisinopril and amlodipine affect the risk of aSAH. This information could help clinicians (including neurologists) make better decisions about which blood pressure medicine to prescribe to lower the risk of aSAH in their patients. This information will also help patients who are at risk of aSAH to use a blood pressure medicine that can potentially lower the risk of an imminent aSAH.
Technical SummaryAneurysmal subarachnoid haemorrhage (aSAH) is a rare type of stroke with high morbidity and mortality, but no pharmacological treatment option. A recent drug-wide association study found signals of a lower aSAH incidence among current users of lisinopril and amlodipine. We aim to investigate whether using lisinopril or amlodipine lowers the risk of aSAH compared to other angiotensin converting enzyme (ACE) inhibitors and dihydropyridine calcium channel blockers (CCBs), respectively.
We will use an active comparator new-user design with data from CPRD GOLD and HES APC. The study population will comprise all adult individuals in CPRD with a hypertension diagnosis between 01.08.2004-31.12.2022. Two cohorts will be formed: initiators of lisinopril versus any other ACE inhibitor, and initiators of amlodipine versus any other dihydropyridine CCBs.
The primary analysis will be conducted using an intention-to-treat design and target trial emulation framework, with patients being followed up from the first prescription date of an exposure or active comparator until aSAH diagnosis, death, transfer out of database, last data collection by CPRD practice, or end of study. In secondary analysis, we will use an on-treatment design to analyse recency of use as well as duration- and dose-response relationships by considering time-varying exposure status and confounders.
Patients with aSAH diagnosis before the index date will be excluded. To account for confounding, propensity scores will be estimated with a 1:1 match of the exposure drug to the active comparator using the nearest neighbour matching algorithm.
Descriptive analyses at baseline will be reported. Incidence rates will be calculated, and a Cox proportional hazards model (multivariable time-dependent in on-treatment design) will be used to estimate the hazard ratios of aSAH associated with the use of lisinopril or amlodipine versus the use of other ACE inhibitors or dihydropyridine CCBs. In addition, a Kaplan-Meier analysis and time-to-event curves will be depicted.
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Validation of proposed National Institute of Health and Care Excellence (NICE) indicator for recording of smoking information in patients with severe mental illness (SMI) in primary care data — Eleanor Yelland ...
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Validation of proposed National Institute of Health and Care Excellence (NICE) indicator for recording of smoking information in patients with severe mental illness (SMI) in primary care data
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-18
Organisations:
Eleanor Yelland - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Jonathan Wray - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Eileen Taylor - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
SMI (schizophrenia, bipolar affective disorder, psychosis); smoking status
Description: Lay Summary
The National Institute for Health and Care Excellence (NICE) develops measures of the quality of care patients are receiving, called indicators, based on published recommendations. These indicators are also put forward for possible inclusion in the Quality Outcomes Framework (QOF), which is a scheme to incentivise good clinical practice in specific areas.
An indicator has been proposed to look at stopping smoking rates in people with severe mental illness. More people within this group are smokers, which puts them at higher risk of a range of health problems. Focused initiatives to support them to not smoke is of major benefit to the patient.The work proposed here will check how well the proposed indicator can be measured within primary care data. We will calculate an indicator measure for the 31st March 2023. We will select a group of patients with a history of severe mental illness at any time before that date, who were recorded as current smokers 1 to 3 years before the 31st of March 2023. From this group, we will look at the number that were recorded as ex-smokers in the last year before the 31st of March 2023. This provides an indicator of the number of people in this group who have stopped smoking.
Checking how well this information can be measured is very important to being able to accurately report on this group and subsequently support general practices in their work in with this patient population to stop smoking.
Technical SummaryThe National Institute for Health and Care Excellence (NICE) develops indicators to measure quality of care outcomes. This piece of work looks to validate the measurement of a proposed NICE indicator in primary care data. This indicator will focus on how well the data can be used to measure the recording of smoking status, and particularly a change from a current to ex-smoker status, in a cohort of patients with severe mental illness. This indicator is being designed as a potential QOF indicator and must therefore be measurable in primary care data.
The study population of interest are patients with a history of severe mental illness who were previously recorded to have a âcurrent smokerâ status. General Practitioners are encouraged to support these patients both to stop smoking and to maintain their ex-smoker status if they have.
Severe mental illness and a prior record of being a current smoker are the primary exposures that qualify a patient for inclusion in the study, and a recent record of being an âex smokerâ is the outcome of interest. A retrospective cohort study design is to be used, with the indicator being calculated as at 31st March 2023. CPRD Aurum primary care data will be the main data source used, with patient-level Index of Multiple Deprivation data additionally linked to stratify the indicator by deprivation quintile. This will support description of potential health inequalities within this indicator measure.
There is a higher prevalence of smoking in patients with severe mental illness and publication of this indicator will provide practices with a clearer picture of how well these patients are being supported to lead healthier lives through good clinical practice. Targeted indicators such as this will benefit patients by focusing and incentivising good clinical practice in areas of clinical need.
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Exploring the role of health inequalities as determined by socioeconomic status in the diagnosis, management and outcomes of patients with asthma in England — Jennifer Quint ...
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Exploring the role of health inequalities as determined by socioeconomic status in the diagnosis, management and outcomes of patients with asthma in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-29
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Zakariah Gassasse - Corresponding Applicant - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Hannah Whittaker - Collaborator - Imperial College LondonOutcomes:
We will measure the following variables across the pathway during the follow-up period:
1. Asthma diagnosis:
⢠Time to asthma diagnosis
⢠Place of diagnosis
⢠Asthma severity upon diagnosis2. Asthma management:
⢠Asthma-related health service utilisation (GP and hospital visits)
⢠Asthma GP consultations defined as 1 or more SNOMED CT codes for asthma-related contact with primary care professionals.
⢠Prescribed medications and treatment
⢠Attendance at annual asthma reviews, comprising inhaler technique and the Royal College of Physicians 3 Questions.
⢠Delivery of personalised action plans3. Asthma outcomes:
⢠Asthma emergency department attendance
⢠Asthma admissions including all, emergency, length of stay, and re-admissions
⢠Asthma ICU admission
⢠Asthma exacerbations
⢠All-cause and cause specific mortality including asthma-related deathDescription: Lay Summary
Asthma is a disease that affects the lungs. Symptoms may include coughing and feeling out of breath. With over 12% of the population diagnosed with asthma, the United Kingdom has one of the highest asthma rates in the world. Almost 70% of all asthma deaths are preventable in the United Kingdom. Meanwhile, the United Kingdomâs National Health Service spends more than £1 billion per year on treating asthma. A 2021 policy paper on the Governmentâs Life Sciences Vision highlighted the need to tackle asthma as one of the leading causes of disease and death.
Differences in wealth may impact asthma. The gap between the richest and poorest has worsened over the last 15 years. One important area to study is which factors drive differences in wealth. These factors impact people with asthma the most. We will use general practice and hospital records to look for differences in people with asthma. We will look at people in different positions in society within England from 2010 onwards.
We will look to see if there are differences in age, sex, and ethnicity. We will also look for differences in patients with other diseases. Patients with asthma may also suffer from these diseases. This research will help tackle why people with asthma in England have different experiences depending on their income.
Technical SummaryAsthma is a chronic respiratory condition characterised by coughing, wheezing, chest tightness and breathlessness, which, if severe, can be debilitating. The UK has one of the highest rates of asthma prevalence worldwide, with inequalities worsening over the last decade. Meanwhile, the UK economy has spent over £1 billion annually on treating and managing asthma. COVID-19 has brought respiratory health, including asthma, to the forefront of public health policy. Few studies have investigated the role of inequalities in asthma care and outcomes. A study in 2021 assessed the association between socioeconomic status and asthma, albeit limited to Wales, before COVID-19 and at the Index of Multiple Deprivation (IMD) quintile level. Building on a previous eRAP 23_003658, we will analyse the association within the English asthma population from 2010 onwards, focussing on the domains that comprise IMD. We will link CPRD Aurum primary care data with Hospital Episode Statistics Admitted Patient Care (exploring hospitalisations, asthma exacerbations, intensive care visits, length of stay, and re-admission), Hospital Episode Statistics A&E (exploring A&E visits and cause-specific A&E visits), ONS Death Registration (exploring mortality). The exposures will be IMD and its domains in quintiles, and the outcomes will be asthma diagnosis, asthma management and asthma outcomes. As a result, policymakers can allocate resources and deliver interventions that improve inequalities in asthma outcomes.
We will fit count regression models, namely negative binomial multilevel models, to estimate the incidence rate ratio for variables that represent the count of asthma-related events within a given IMD quintile compared with the least deprived quintile. We will fit logistic and survival models to determine the factors associated with asthma-related death. All models will be adjusted for relevant covariates, including sex, age, ethnicity, and other risk factors.
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Feasibility study on care pathway for attention deficit hyperactive disorder between the primary and secondary care settings — Indraraj Umesh Doobaree ...
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Feasibility study on care pathway for attention deficit hyperactive disorder between the primary and secondary care settings
Datasets:GP data, CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register; CPRD GOLD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-11
Organisations:
Indraraj Umesh Doobaree - Chief Investigator - Takeda UK Limited
Indraraj Umesh Doobaree - Corresponding Applicant - Takeda UK Limited
Ananya Roy Chowdhury - Collaborator - Takeda Development Center Americas, Inc.
Ning (Julia) Zhu - Collaborator - Takeda Development Center Americas, Inc.
SUDHAKAR MANNE - Collaborator - Takeda Development Center Americas, Inc.Outcomes:
Diagnosis by age group or age
ADHD care: prescribed medications, other forms of therapy, duration of treatment
Persistence and adherence to prescribed medication and follow up care
Reasons for discontinuation or switch
Specialty
Hospitalisation
Care received in: primary setting, inpatient, outpatient, Accident and Emergency
Comorbidities
Difference in care by level of deprivation
Mortality (all cause and cause-specific)
Referrals between primary and secondary care
Childbirth among patients with ADHD (as proxy to parental responsibility)Description: Lay Summary
Attention deficit hyperactivity disorder (ADHD) can cause a person to have problem concentrating, being overactive or act on impulse. Both children and adults can be affected. It is usually accompanied with other psychological conditions, such as anxiety and depression, which can pose challenges for its accurate diagnosis. Given that the disorder is under-recognised among adults, many are untreated or under-treated and have experienced problems in their adult life, including disability, impaired quality of life, poor marital relationships, poor work performance, and sometimes premature death due to their increased likelihood to accidents. There is also limited data on how many patients continue with their ADHD care whether from childhood to adulthood but especially for patients who were diagnosed in adulthood. To investigate this further, it is important to identify the correct data source to describe ADHD patientsâ care from childhood to adulthood and for those who were diagnosed in adulthood. Their persistence and compliance in continuing ADHD care, including âsharedâ care between general practitioners and psychiatrist, need to be described for United Kingdom. This feasibility study proposed here will assess whether the Clinical Practice Research DataLink linked to the Hospital Episodes Statistics has the relevant primary and secondary care data to facilitate this study. The findings from this feasibility will inform the decision to undertake future research in describing the problem that ADHD patients encounter in continuing their care so that healthcare professionals and service provide can find solutions to address them.
Technical SummaryAttention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder that manifests as trouble concentrating, hyperactivity, and impulsiveness. ADHD can affect children and adults. However, it is less recognised among adults. ADHD can have an adverse impact on a person's quality of life, relationships, parental responsibility, work productivity, and being prone to have accidents. Comorbid psychological conditions, such as anxiety, depression and obsessive-compulsive disorders, can make the diagnosis of ADHD challenging. This feasibility study will assess how the Clinical Practice Research DataLink (CPRD) linked to the Hospital Episodes Statistics (HES) datasets can be utilised to describe persistence and adherence in continuing ADHD care, including âsharedâ care between general practitioners and psychiatrist. The possibility of describing ADHD patientsâ care from childhood to adulthood and for those who were diagnosed in adulthood will also be assessed. Basic summary statistics (including counts, proportions, mean and, standard deviations, medians and interquartile ranges, etc) will be obtained and finding on less than 5 patients will be suppressed. Rates in person-time will be calculated wherever appropriate. The findings from this feasibility will inform the decision to undertake future research in describing the problems that ADHD patients encounter in continuing their care so that healthcare professionals and service providers can find solutions to address them. Measures in improving access or ensuring continued ADHD care in adulthood can lessen the impact of ADHD on their disability, work performance and bring improvement to their quality of life, relationships, parental responsibility as well as reduce the likelihood of premature death due accidents. In turn, these can lessen the burden of health and social care.
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POSTPARTUM DEPRESSION CHARACTERISTICS AND MATERNAL-INFANT PATIENT JOURNEY IN THE UK — Cai Gillis ...
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POSTPARTUM DEPRESSION CHARACTERISTICS AND MATERNAL-INFANT PATIENT JOURNEY IN THE UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-17
Organisations:
Cai Gillis - Chief Investigator - Biogen
Cai Gillis - Corresponding Applicant - Biogen
Catherine Mak - Collaborator - Biogen Inc.
Ellen Tworkoski - Collaborator - Biogen
Li Li - Collaborator - Biogen
Manja Koch - Collaborator - Biogen Inc.
Nancy Maserejian - Collaborator - Biogen
Shih-Yin Chen - Collaborator - Biogen
Susan Eaton - Collaborator - BiogenOutcomes:
Primary outcome: Postpartum depression diagnosis cumulative incidence
Secondary outcomes: prescription medications; comorbidities; infant six-week check; all-cause hospitalization; GP visits; postnatal depression screening; mortality; failure to thrive in infants; mental health referralsDescription: Lay Summary
Depression within the first year after giving birth (postpartum depression) is a serious mood disorder that affects daily life. A better understanding of depression among women with a recent pregnancy in the UK is important to help families, clinicians, and policy leaders. The overall aim of this study is to examine the frequency of depression diagnosis among women in the first year after giving birth in the UK. In addition, the study will compare mothers who get diagnosed with postpartum depression to mothers who do not get diagnosed, to examine differences in characteristics such as age, depression screenings, medications, other health problems, death, and health problems with the infant. In addition, the study will examine how often women with postpartum depression have health care visits, including hospitalizations, general practitioner visits, and six-week infant checks.
Technical SummaryWe aim to examine the 12-month cumulative incidence of diagnosed postpartum depression (PPD) and patient characteristics of pregnancy episodes with and without a diagnosis of PPD.
Eligible participants between 12-55 years will be drawn from the CPRD Pregnancy Register with an end date of pregnancy January 2017 to December 2021, excluding those with prior history of manic/bipolar episodes. Pregnancy Register data will be used to identify pregnancy episodes and the mother-baby-link used to follow health outcomes for mother and infant.
In a cohort study, participants are followed 12-months for incident PPD. PPD will be defined in two methods; one using a more restricted definition (only PPD codes) and one a broader definition (PPD and depression codes).
In a case-control design, we will use descriptive statistics in the year before and after index to compare patient characteristics including demographics, medications, and comorbidities between pregnancy episode cases with PPD to matched controls without PPD during the study period.
Using linked data from HES Admitted Patient Care, we will examine in-patient spells comparing PPD cases and controls. We will examine mean number of spells, duration, reasons for hospitalization and healthcare utilization.
HES Outpatient data will be linked to examine outpatient visits in mothers and infants; and HES Accident and Injury to examine emergency visits, maternal self-harm episodes, and maternal suicide attempts.
ONS death registration data will be used to examine mortality in mothers and infants.
Cox models and KM survival curves will be used to understand time to PPD diagnosis, screening, psychotropic medication initiation/discontinuation, and time to self-harm and suicide attempts in mothers; and time to first spell, first accident/emergency visit, and death in mothers and linked infants.
Findings from this work will be submitted to conferences to increase knowledge of PPD characteristics in the UK and will aid PPD drug development efforts.
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Disparities in uptake of Shingrix(R) vaccine in the eligible immunosuppressed population in England: a cohort study — Kathryn Mansfield ...
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Disparities in uptake of Shingrix(R) vaccine in the eligible immunosuppressed population in England: a cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-04-11
Organisations:
Kathryn Mansfield - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anne Suffel - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Colin Campbell - Collaborator - UK Health Security Agency (UKHSA)
Edward Parker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Eleanor Barry - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - UK Health Security Agency (UKHSA)
Julia Stowe - Collaborator - UK Health Security Agency (UKHSA)
Meredith Leston - Collaborator - University of Oxford
Nick Andrews - Collaborator - UK Health Security Agency (UKHSA)
Rosalind Goudie - Collaborator - University of Oxford
Simon de Lusignan - Collaborator - University of Oxford
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Shringrix® vaccine uptake
Description: Lay Summary
Around one in four adults will experience shingles in their lifetime. Shingles is a viral infection that causes a painful rash. Usually, the rash is on one side of the chest or belly. But it can also appear anywhere including the face. Shingles can also have other symptoms like headaches and feeling generally unwell. Shingles symptoms usually resolve within 4 weeks. But some people experience continuing pain and other serious complications. This ongoing, or more often intermittent, pain is called âpost-herpetic neuralgiaâ. One of the main reasons for giving a shingles vaccine is to prevent this lasting pain.
People with weak immune systems are more likely to get shingles and for it to be more severe. There are two effective vaccines that reduce shingles risk and severity. One vaccine, Shingrix®, has been given in the UK since September 2021 to people aged 70-79 with weak immune systems. We want to investigate whether the Shingrix® vaccine is reaching the people who need it. If we understand who is less likely to get Shingrix®, we can adapt the programme to better reach those people. It is important that we can get the vaccine to people who need it to reduce the risk of them experiencing shingles and its complications.
Technical SummaryOur study aims to describe coverage and potential disparities in Shingrix® vaccine uptake in eligible immunosuppressed adults in England. Our main analysis will be a cohort study of Shingrix®-eligible immunosuppressed adults born 1942-1953 (from 01-Sept-2021 to 31-Aug-2023).
Individuals will enter the study from the latest of: study start (01-Sept-2021), the year they turn 70, one year after current practice registration, or date meeting our immunosuppression definition. We will exclude individuals receiving Zostavax® before study start. Individuals will be eligible for inclusion until the earliest of: end of study (31-Aug-2023), age 80, death, practice no longer contributing to CPRD, end of registration, or no longer meeting our immunosuppression definition.
We will describe the number and proportion of eligible immunosuppressed adults aged 70-79 years (both overall and stratified by potential factors related to uptake) receiving: 1) at least one Shingrix® vaccination; and 2) two doses of Shingrix® received 7 weeks to 13 months after the first (i.e., complete course). We will use logistic regression (adjusting sequentially based on a hierarchical conceptual framework developed for each specific uptake-related factor of interest) to estimate odds ratios for the association between each potential uptake-related factor and receiving at least one Shingrix® vaccine. Potential uptake-related factors will include: 1) sociodemographic (e.g., sex, deprivation, ethnicity, geographic region); 2) clinical (e.g., mental health conditions, reason for immunosuppression); and 3) lifestyle (e.g., smoking, harmful alcohol use) factors.
We will describe the number and proportion of eligible immunosuppressed individuals receiving: 1) inadvertent Zostavax®; and 2) receiving co-administration of Shingrix® with seasonal influenza vaccination.
In a secondary analysis, we will describe uptake of at least one dose of Shingrix® (by age, sex, deprivation, ethnicity) from 1st September 2023 (following vaccination programme changes) in adults: 1) aged 50+ with immunosuppression; 2) stem cell transplant recipients aged 18-49; and 3) immunocompetent aged 60-79.
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ID-403: Analysis of HRCH Caseloads within Falls and Bone Health/ICRS/CRS to identify if patients from part of cohort of ED Attendances and/or Hospital Admissions at West Middlesex Hospital (ChelWest) for a Falls related event — Hounslow and Richmond Community Healthcare NHS Trust...
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ID-403: Analysis of HRCH Caseloads within Falls and Bone Health/ICRS/CRS to identify if patients from part of cohort of ED Attendances and/or Hospital Admissions at West Middlesex Hospital (ChelWest) for a Falls related event
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-24
Opt Outs: no information provided./p>
Organisations: Hounslow and Richmond Community Healthcare NHS Trust
Description: Falls and bone health.
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ID-404: Hypertension — Imperial College London...
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ID-404: Hypertension
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Hypertension.
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ID-402: Economic evaluation of the Early Years Pilot Project in North West London — Brunel University of London...
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ID-402: Economic evaluation of the Early Years Pilot Project in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-24
Opt Outs: no information provided./p>
Organisations: Brunel University of London
Description: Children under 5 years old.
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ID-401: Bi-Borough Care Homes Non-Elective Avoidable Admissions Audit — West London Borough Team...
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ID-401: Bi-Borough Care Homes Non-Elective Avoidable Admissions Audit
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-24
Opt Outs: no information provided./p>
Organisations: West London Borough Team
Description: Care home admissions.
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ID-400: An evaluation of the uptake of vaccines in London Borough of Hammersmith and Fulham — London Borough of Hammersmith and Fulham...
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ID-400: An evaluation of the uptake of vaccines in London Borough of Hammersmith and Fulham
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-24
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith and Fulham
Description: Vaccination.
Source
2024 - 03
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Healthy Households — unknown...
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Healthy Households
Where: unstated
When: 2024-3-12
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project will create a new research-ready dataset by linking housing data with other administrative and health data for England, Scotland and Wales. The project team will also develop tools to support researchers in using this data. This will enable new, policy-relevant insights into the make-up of households and the circumstances they experience.
The composition of households can play a role in the social, economic and health outcomes of those who live in them. In particular, the Covid-19 pandemic and associated lockdowns have highlighted the impact of circumstances such as over-crowding on physical and mental health and education. However, it is currently not possible for researchers to analyse households within administrative and health population datasets.
This project aims to address this challenge using Unique Property Reference Numbers (UPRNs) â unique identifiers given to every addressable location in the UK. Encrypting or coding these unique numbers provides a secure way to link de-identified information about people sharing the same household, and to link this to other address level data. This will enable research that recognises the make-up and circumstances of individual households while investigating the outcomes experienced by household members.
This project is funded by ADR England and will be delivered by ADR Wales, led by Dr Richard Fry, Professor of Environment and Health at Swansea University. Collaborating on the project alongside Swansea University are the University of Edinburgh, Queen Mary University of London and Endeavour Health Charitable Trust.
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ASTRIS-UK: Antithrombotic treatment patterns and risk of STroke Recurrence or major bleeding in patients with non-cardioembolic Ischemic Stroke from the UK — Kristian Tore Jørgensen ...
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ASTRIS-UK: Antithrombotic treatment patterns and risk of STroke Recurrence or major bleeding in patients with non-cardioembolic Ischemic Stroke from the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-04
Organisations:
Kristian Tore Jørgensen - Chief Investigator - Bayer A/S - Denmark
Luis Alberto Garcia Rodriguez - Corresponding Applicant - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Antonio Gonzalez Perez - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Oscar Fernández Cantero - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )Outcomes:
Recurrent IS; Intracranial bleed; Stroke (both ischemic or hemorrhagic); Major bleed; All cause death
Description: Lay Summary
Stroke (also known as brain attack) occurs when blood cannot get to your brain and represents a serious health problem worldwide. Even though management and treatment of this condition has improved in recent years, the risk of having a new stroke is still a big challenge. People who have a stroke that is somehow related to heart disease need different care than those with a stroke not related to heart disease. Thus, these two types of events must be studied separately. This study wants to find out how likely it is for someone to have a new stroke or a major bleeding problem after leaving the hospital for a stroke that was unrelated to heart disease. We are going to look at data from a UK health database to do this. We will track people with a stroke since they leave hospital until they have a new stroke, a major bleeding issue, or die. We will also study how sex, age, lifestyle, or previous health problems have an influence on what happens to these patients. We will also describe what kind of medicines they take to prevent these problems. By doing this, we hope to learn more about how often strokes happen again and how well treatments work. This information can help patients, doctors, and health planners make better decisions.
Technical SummaryIschemic stroke (IS) is a major cause of mortality and morbidity worldwide. Despite advances in acute stroke management, the risk of recurrent stroke still poses a significant challenge. Management of individuals who experience a cardiogenic IS differs greatly from those experiencing a non-cardioembolic stroke. This study aims to explore the risk of recurrent IS and major bleeding events after a discharge for a non-cardioembolic IS. To estimate the occurrence and explore the determinants of these events (including the antithrombotic therapy initiated after the index IS) we plan to conduct a retrospective cohort study using CPRD-Aurum database from the UK, along with linked HES databases. We will identify hospital admissions compatible with non-cardiogenic IS recorded on HES during the study period (1/1/2012-28/02/2020). We will follow individuals starting 15 days after discharge until the occurrence of each study endpoint: a) Recurrent IS, Intracranial bleed, c) Stroke, d) Major bleed, and e) All cause death. We will estimate the incidence rate of these study events and describe patientsâ characteristics including demographics, lifestyle factors, comorbidity and healthcare utilization at baseline (index IS event) as well as at time of recurrence among those patients experience a recurrent IS event. Patterns of antithrombotic use will also be described at various time points before and after the index IS event, and also after an IS recurrence. Survival analyses will be performed to explore time to the occurrence of the study endpoints and to assess the determinants of these events. Multivariable adjusted Cox proportional hazards regression models will be used to this end. In summary, this study will update our knowledge about stroke recurrence and patterns of preventive treatment in recent years concerning non-cardioembolic stroke. We believe this will be of importance to patients, their physicians, and health planners.
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Effectiveness of Disease Modifying Anti-Rheumatic Drugs in people with diagnosed Rheumatoid Arthritis: Cohort study using routinely recorded clinical data — Polina Prokopovich ...
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Effectiveness of Disease Modifying Anti-Rheumatic Drugs in people with diagnosed Rheumatoid Arthritis: Cohort study using routinely recorded clinical data
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-12
Organisations:
Polina Prokopovich - Chief Investigator - Cardiff University
Polina Prokopovich - Corresponding Applicant - Cardiff University
Harry Ahmed - Collaborator - Cardiff University
Tahaneiy Kadi - Collaborator - Cardiff UniversityOutcomes:
For the primary objective: at the time of first prescription of each DMARD
- age, gender, BMI, smoking status, alcohol consumption status
- comorbidity history
- number of previous DMARD molecule prescribed
- time on DMARD treatment (total and for each molecule)
- treatment pathways (second and subsequent lines of therapy)For the first secondary objective
- treatment failure (count and proportion)
- time-to-treatment failure
- extra-articular manifestations involvement due to treatment failureDescription: Lay Summary
Rheumatoid arthritis (RA) is a chronic disease that causes inflammation in different joints of the body. RA causes significant symptoms, including pain, fatigue, and joint deformities, leading to significant morbidity and lower quality of life. RA is a major cause of healthcare use and expenditure. Symptoms and progression of RA can be delayed with Disease Modifying Drugs (DMARDs). Unfortunately, some patients fail to respond to some of these treatments and require switching to a different drug to find an effective treatment. Change of treatment results in drug wastage, further costs for the NHS for additional visits to doctors. Moreover, receiving an ineffective treatment does not improve patientsâ quality of life. The wide range of medication available for RA increases the challenge for clinicians to prescribe the most appropriate drug for each patient. This study aims to (i) Describe the socio-demographic and clinical characteristics associated with the initiation of different RA treatments; (ii) Describe rates and factors associated with treatment failure and (iii) Develop models to predict the treatment least likely to fail for each patient.
Technical Summary
The results of this study will inform clinicians about the most effective DMARD therapy for specific individuals to reduce treatment failure of patients in the UK. This increase in knowledge may help to update local guidelines and initiate active monitoring of RA patients at high risk of treatment failure in order to anticipate/prevent treatment failure consequences.Rheumatoid arthritis (RA) is a chronic, symmetrical inflammatory autoimmune disease that causes functional impairment with diminished capacity for work and social engagement, and substantial direct medical expenditures. Despite the availability and effectiveness of disease modified anti-rheumatic medication (DMARD) therapies, some patients fail to respond to such medications on repeated occasions (treatment failure). The treatment switching resulting from failure of the prescribed drugs is both an economic concern (drug wastage and further contact with the NHS to resolve disease flares and prescribe a new treatment) and a reduction of patientsâ quality of life.
The aim of this study is to identify the DMARD most likely to result in treatment success for RA patients based on routinely recorded clinical variables in order to achieve better outcomes for patients with RA and improve NHS resources use.
There is a relative scarcity of studies that elucidate risk factors for RA treatment failure at individual drug level, particularly for the UK population.
CPRD patients over 18 years olds at the time of RA diagnose and prescribed DMARD therapy will be included in this retrospective longitudinal study.
Summary descriptive statistics will be generated characterising patient demographics, clinical and treatment characteristics, in relation to stratification of risk of RA treatment failure.
Safety and effectiveness of different types of DMARD will be compared using a causal framework; moreover a de novo risk prediction models of RA treatment failure that use âtraditionalâ methods of statistical regression modelling or novel machine learning algorithms will be developed using the available demographic and medical data.The resulting set of risk equations will be reflective of current patients in England and will provide real word evidence to clinical and policy decision making.
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Feasibility study of the risk and long-term outcomes of acute kidney injury among chronic kidney disease patients undergoing cardiopulmonary bypass procedure in the UK — Kyaw Joe Sint ...
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Feasibility study of the risk and long-term outcomes of acute kidney injury among chronic kidney disease patients undergoing cardiopulmonary bypass procedure in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-28
Organisations:
Kyaw Joe Sint - Chief Investigator - Alexion Pharmaceuticals, Inc ( USA )
Kyaw Joe Sint - Corresponding Applicant - Alexion Pharmaceuticals, Inc ( USA )
Francesca Gatta - Collaborator - AstraZeneca GmbHOutcomes:
Acute kidney injury; AKI severity; CKD progression; dialysis; kidney transplant; all-cause mortality; hospitalization, A&E admission, outpatient visits.
Description: Lay Summary
Patients with chronic kidney disease (CKD) undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at high risk for cardiac surgery associated acute kidney injury (CSA-AKI). Using the primary care CPRD database and linking it with hospital and mortality records, this feasibility study aims to determine the feasibility of determining acute kidney injury among patients undergoing cardiopulmonary bypass procedures and long-term outcomes of CKD progression, dialysis, kidney transplant, mortality, hospitalizations, A&E admissions, and outpatient visits.
If acute kidney injury and renal outcomes are able to be identified in the feasibility study, a future study will be planned to estimate 1) the incidence of AKI following CPB; 2) the demographic and clinical predictors of developing AKI; and 3) the short-term and long-term outcomes of patients who developed and did not develop AKI post-CPB. The future study will identify variables such as age, pre-existing conditions, and procedural factors, which may correlate with the onset of AKI. Furthermore, outcome measures, including subsequent renal function, duration of hospitalization, and mortality, will be analysed to understand the long-term outcomes of AKI post-CPB. The study will help understand the patient journey and medical need of patients experiencing acute kidney injury after CPB procedure in England and Wales.
Technical SummaryThis feasibility study aims to assess the feasibility of determining acute kidney injury (AKI) and outcomes among patients undergoing surgeries involving cardiopulmonary bypass (CPB) by utilizing the CPRD primary database linked with hospital episode statistics (HES) and ONS mortality data. AKI is recognized for its clinical significance due to its common occurrence post-CPB and its association with increased morbidity and mortality. The CPRD, anonymised primary care records, and linkage with HES facilitates a comprehensive examination of patient medical histories.
Based on CPRD GOLD primary care data of patients undergoing CPB, not limited to patients with CKD from 2010 to 2022 results in 16,411 procedures from 14,036 patients. However, the number of patients with available renal function data (serum creatinine and eGFR) is limited near time of surgery (about 4-6% around the week of surgery) and low numbers of records of dialysis. The protocol seeks to link the CPRD primary care data with the HES and ONS data to assess acute kidney injury and outcomes including CKD progression, dialysis, hospitalizations, and mortality.
For the feasibility study with linked data, descriptive statistics such as mean, standard deviation, interquartile range, minimum, and maximum for the number of events and count and percent for the occurrence of events will be analyzed. Only patients with CKD stage 3 or 4 and without stage 5 or ESRD in the 6 months prior to surgery will be included in the study.
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Influence of smoking status or vaping on severity of chronic obstructive pulmonary disease (COPD) at diagnosis, COPD management, and comorbidity diagnosis and management — Jennifer Quint ...
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Influence of smoking status or vaping on severity of chronic obstructive pulmonary disease (COPD) at diagnosis, COPD management, and comorbidity diagnosis and management
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-28
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Rong Ding - Corresponding Applicant - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Sarah Cook - Collaborator - Imperial College LondonOutcomes:
Objective 1
1. Sociodemographic factors of COPD patients at the time of diagnosis
2. Disease severity of COPD patients at the time of diagnosis
3. Prevalence of comorbidities in COPD patients at the time of diagnosis
Objective 2
4. COPD management (pharmacological and non-pharmacological)
5. Health service utilisation (annual review attendance, vaccination taken for flu, COVID and pneumonia)
6. Treatment outcomes (exacerbations, mortality, and lung function)
Objective 3
7. Comorbidity managementDescription: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a very common health condition that causes breathing problems. COPD is a leading cause of death worldwide, with smoking and vaping causing COPD symptoms such breathlessness for patients. COPD management is complex due to development of more than one illness at once. This is known as comorbidities. There is no cure for COPD. Reducing or stopping smoking is likely to prevent COPD symptoms from getting worse.
Stopping smoking is an essential method for relieving the symptoms of COPD. Vaping was introduced to help people stop smoking. It may be less harmful, but repeated vaping may still cause detrimental effects. The impact of this on COPD management is unknown.
Smoking and vaping can lead to bad social perceptions (stigma) in finding the cause of disease. This impacts disease management and has a negative impact on patients who smoke or vape. COPD patients with different smoking conditions may have other causes of disease and comorbidities. This may refer to current or ex-smokers.
This study will explore the difference between current smokers, ex-smokers, non-smokers, and vapers in terms of diagnosis, disease management, and comorbidities of COPD. This study will benefit the public by evaluating how smoking and vaping effects the risk of COPD and provide a better understanding towards the health effects of vaping.
Technical SummaryCOPD is a leading cause of death worldwide; the prevalence is around 174 million and it has caused 3.2 million deaths. There are about 3 million people in the UK living with COPD, which is around 4% of the population, among them only one third have been diagnosed.
Diagnosis of COPD is based on clinical symptoms and spirometry, but there is often a delay in diagnosis. The current focus of COPD treatment is on COPD prevention, stopping exacerbations, and relieving symptoms. Comorbidities are common, 97.7% of COPD patients have at least one comorbidity and the majority have at least four.
Smoking increases the risk of developing COPD. However, whether current or ex-smokers or those vaping have differing disease severity at diagnosis, are managed differently or have a different pattern of co-morbidity development is not clear.
The aim of this study is to investigate how current or former smoking or vaping impact on COPD diagnosis and management among patients in England.
We will use CPRD Aurum data linked with ONS death registration data, HES admitted patient care and patient level index of multiple deprivation. We will use descriptive statistics and compare the characteristics at the time of diagnosis in participants with different smoking conditions. We will use Cox regression models to study the time to first steroid prescription and the occurrence of comorbidity. Poisson or Negative Binomial regression models will be used to determine the number of hospital visits by a patient during the study period. This will guide further study about how the management of COPD and COPD comorbidity differs between smokers, ex-smokers, vapers and non-smokers. For example, hypertension will be selected as one of the comorbidities to focus on. We will mainly focus on the treatment for hypertension, including pharmacological treatment and non-pharmacological treatment.
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Ethnic differences in the trajectory of blood glucose levels during type 2 diabetes treatment in UK primary care, and how adherence influences care; a cohort study — Krishnan Bhaskaran ...
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Ethnic differences in the trajectory of blood glucose levels during type 2 diabetes treatment in UK primary care, and how adherence influences care; a cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-18
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nishi Chaturvedi - Collaborator - University College London ( UCL )
Rohini Mathur - Collaborator - Queen Mary University of London
Sophie Eastwood - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
HbA1c trajectories during first/ second/ third to fifth years of glucose-lowering medication use; time-points at which HbA1c reached 58 mmol/mol (second-line therapy threshold); overall HbA1c trajectory; glucose-lowering treatment intensification
Description: Lay Summary
Type 2 diabetes occurs when the bodyâs normal ways of controlling levels of sugar in the blood are not working properly. UK South Asian or African/African Caribbean groups are more likely to develop diabetes complications e.g. strokes, than European groups. Maintaining near-normal blood sugar levels is important to reduce complications in type 2 diabetes, but few studies compare long-term blood sugar levels by ethnicity. Many people with type 2 diabetes struggle to take their medication regularly, but how this impacts the way their diabetes treatment progresses has not been studied, and ethnic differences in how consistently people take their treatments are unclear.
Using electronic health records, we will compare how average blood sugar levels rise and fall over time for people of European, South Asian and African/African Caribbean ethnicity in the first five years after starting medication for type 2 diabetes. The study will also examine how any ethnic differences we find may vary by blood sugar levels at treatment commencement, age, gender, socioeconomic factors, co-existing medical conditions and medication, healthcare usage and other treatments. We will also study whether diabetes treatments are more likely to be changed if someone does not take their medication regularly, and how this varies by ethnicity.
By uncovering ethnic inequalities in blood sugar control for people with type 2 diabetes, their possible explanations and how medication-taking impacts treatment changes, we will better understand where improvements in diabetes care are needed to reduce excess complications experienced by UK South Asian and African/African Caribbean groups.
Technical SummaryPeople with type 2 diabetes of UK South Asian and African/African Caribbean ethnicity experience more complications than those of European ethnicity. Cross-sectional studies demonstrate worse diabetic control (indicated by higher levels of HbA1c, a measure of the mean preceding 2-3 monthsâ blood glucose levels) for South Asian and African/African Caribbean than European groups. However, evidence is limited regarding ethnic differences in HbA1c trajectories, though trajectories of glucose over time are more strongly related to the likelihood of diabetes complications than one-off measurements. Moreover, a third of people with type 2 diabetes are non-adherent to glucose-lowering medication; resultant poor glycaemic control may result in unnecessary treatment intensification, but it is unclear to what extent poor adherence leads to treatment switches, and how this varies by ethnicity.
We will identify a cohort of individuals from primary care electronic medical records with incident type 2 diabetes commencing glucose-lowering medication. Ethnic differences in HbA1c trajectories in the five years following glucose-lowering medication initiation will be studied. Time to second-line glucose-lowering medication requirement according to UK national guidelines (i.e. when HbA1c>58 mmol/mol) will be compared by ethnicity. Sub-group analyses will examine how ethnic differences vary by: baseline HbA1c, socio-demographic factors, treatment factors including non-adherence, calendar period, BMI, comorbidity, polypharmacy and healthcare use. Proportions of non-adherent people receiving treatment intensification, and the determinants of inappropriate treatment intensification will be investigated.
Established algorithms and code lists will define ethnicity, diagnoses and medication use. Data will be analysed by ethnicity, using piecewise linear models to quantify HbA1c change during the first, second and third to fifth years of treatment and to determine mean time-points at which HbA1c reaches 58 mmol/mol. Stratified analyses will explore the role of potential drivers of ethnic differences in HbA1c trajectories. Logistic models will be used to investigate associations between adherence and treatment intensification.
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Novel analytical methods for predicting risk, diagnosis, and progression of heart failure (STRATIFYHF) — Sarah Charman ...
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Novel analytical methods for predicting risk, diagnosis, and progression of heart failure (STRATIFYHF)
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-12
Organisations:
Sarah Charman - Chief Investigator - Newcastle University
Sarah Charman - Corresponding Applicant - Newcastle University
Amy Fuller - Collaborator - Coventry University
David Sinclair - Collaborator - Newcastle University
Djordje Jakovljevic - Collaborator - Coventry University
Duncan Edwards - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of Cambridge
Matej PiÄulin - Collaborator - University of Ljubljana
Nduka Okwose - Collaborator - Coventry University
Petar VraÄar - Collaborator - University of Ljubljana
Zoran Bosnic - Collaborator - University of LjubljanaOutcomes:
The primary outcome for the patients diagnosed with HF is hospitalisation rate during the five years of diagnosis.
The secondary outcomes are:
2. Heart failure symptoms (including the presence of breathlessness, fatigue, or ankle swelling, as recorded in primary care records using SNOMED CT symptom codes)3. Frequency of primary care clinical appointments per year (including 4+ minute GP appointment, 4+ minute practice nurse appointment, home visit appointment, out of hours appointment)
7. Mortality using the ONS Death Registration DataThe primary outcome for the patients at high and low risk of HF is diagnosis of HF.
There are no secondary outcomes for the patients are high and low risk of HF.Description: Lay Summary
Heart failure (HF) is widespread and affects up to 15 million people in Europe. It is a complex clinical syndrome presenting with reduced heart function. Individuals diagnosed with HF have poor quality of life. HF is an expensive disease to manage and requires engagement of entire teams of healthcare professionals. There is a high clinical demand for novel techniques to be developed to assist in early diagnosis and prediction of HF. Artificial intelligence (AI) has enormous potential in the medical field for early and accurate prediction of HF and its progression.
Technical Summary
Such tools are essential to allow early initiation of prevention and treatment strategies which will improve patientâs quality of life and reduce overall HF burden on patients and healthcare. STRATIFYHF (EU Horizon-, UKRI-funded project) aims to develop, validate and implement novel AI-methods to advance early prediction of HF and to detect those who may already have disease but do not know they have it. The AI methods will integrate patient-specific demographic and clinical data using existing and novel technologies and develop AI-based tools (computer software) for predicting HF. STRATIFYHF project aims to change the way in which HF is diagnosed today and thereby improve the quality and length of patientsâ lives and lead to efficient and sustainable healthcare systems.This study aims to address the global challenge of identifying individuals at risk of HF and predicting prognosis of those living with HF. A retrospective cohort study will be conducted from 1st January 2004 to 31st January 2024. We aim to retrospectively identify two populations cohorts (patients diagnosed with HF, patients at-risk of HF (low and high)) using SMOMED-CT clinical codes and will construct a predictive model (Decision Support System, DSS, STRATIFYHF) for risk prediction of HF and prognosis of those living with HF using sex, age, ethnicity and linked to HES Admitted Patient Care for hospitalisations, HES Diagnostic Imaging Dataset for frequency of imaging, HES Outpatient for frequency of appointments and ONS Death Registration. The statistical methods will include advanced models such as Random Forest, XGBoost and Neural Networks. Both population cohorts will be identified and permanently registered on CPRD for >5 years. The primary outcome for the patients diagnosed with HF is hospitalisation rate during the five years of diagnosis. Secondary outcomes for patients diagnosed with HF will include: incidence rates for comorbidities, frequency of HF symptoms, frequency of appointments, prescriptions and mortality. The primary outcome for patients at risk (low and high) of HF is diagnosis of HF.
This study and the development of the DSS (STRATIFYHF) may improve risk prediction and prognosis of HF thus enhancing patientâs quality of life and leading to a more cost-effective health care system.
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COVID-19 booster vaccine effectiveness in secondary prevention of major adverse cardiovascular events: an emulated target trial in observational data — Patrick Souverein ...
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COVID-19 booster vaccine effectiveness in secondary prevention of major adverse cardiovascular events: an emulated target trial in observational data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-01
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Geert-Jan Geersing - Collaborator - University Medical Centre Utrecht
Hannah la Roi-Teeuw - Collaborator - University Medical Centre Utrecht
Helga Gardarsdottir - Collaborator - Utrecht University
Jungyeon Choi - Collaborator - University Medical Centre Utrecht
Maarten van Smeden - Collaborator - University Medical Centre Utrecht
Sander van Doorn - Collaborator - University Medical Centre Utrecht
Sophie Bots - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes:
Major adverse cardiovascular events consisting of myocardial infarction and ischemic or hemorrhagic stroke; All-cause mortality
Description: Lay Summary
Previous studies have shown that individuals have a higher risk of heart and brain attacks after contracting COVID-19. This study aims to determine if a booster vaccination for COVID-19 can prevent such attacks in people who have already experienced heart or brain attacks in the past (the so called âhigh-riskâ population). We will use routine care data from the first UK booster campaign. We will compare âhigh-riskâ individuals who received a booster vaccine to those who have not yet received it, using advanced statistical methods to account for any differences between the groups. We will estimate the difference between obtaining a booster vaccine and not obtaining a booster vaccine in the risk of heart and brain attacks after 24 weeks. Our findings could help inform policy makers about the benefit of COVID-19 booster vaccinations. For example, we currently know that the yearly flu shot can prevent heart and brain attacks in patients with heart and circulatory disease. In this study we may find out whether that also holds true for the COVID-19 booster.
Technical SummaryLiterature suggests that COVID-19 increases the risk of major adverse cardiovascular events (MACE). Current debates focus on yearly COVID-19 booster vaccination in high-risk populations with the aim to reduce morbidity and mortality. The current study aims to answer the research question: What is the effectiveness of COVID-19 booster vaccination on MACE reduction in individuals with a history of cardiovascular disease? The study is designed to emulate sequential target trials in observational routine care data from the United Kingdomâs Clinical Practice Research Datalink (Aurum/HES).
Patients with existing cardiovascular disease aged 40 years or older who were eligible for booster (third dose) COVID-19 vaccination in the period of September to December 2021 will be included. Participants receiving a third vaccine dose (intervention) or not (yet) receiving a third vaccine dose (controls) will be compared on the 24-week risk difference in MACE (composite of stroke and myocardial infarction) with all-cause mortality as competing risk.Data will be analyzed as sequentially emulated trials. Within each calendar week, all eligible individuals will be enrolled to either the intervention group (if they received the booster that week) or the control group (if they had not received the booster up to that week) and followed-up until MACE, death, loss to follow-up (censoring), protocol deviation (if individuals in the control group receive the booster) or the maximum follow-up duration of 24 weeks. Inverse probability weighting will be used to adjust for baseline differences between treatment arms, and potential time-varying confounding due to loss to follow-up or protocol deviation, using pooled logistic regression to determine the weights. The total effect of booster vaccination will be estimated using a weighted non-parametric cumulative incidence function, deriving absolute risk differences and risk ratios for MACE within 12 and 24 weeks of follow-up in the presence of all-cause death as competing event.
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Burden of disease in high-risk patients without prior myocardial infarction or stroke in the UK — Queenie Chan ...
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Burden of disease in high-risk patients without prior myocardial infarction or stroke in the UK
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-28
Organisations:
Queenie Chan - Chief Investigator - Amgen Ltd
Queenie Chan - Corresponding Applicant - Amgen Ltd
David Neasham - Collaborator - Amgen Ltd
Francesco Giorgianni - Collaborator - Amgen Ltd
Ian Wong - Collaborator - University College London ( UCL )
Isobel Piper - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Meda Sandu - Collaborator - Amgen Ltd
Michael Duxbury - Collaborator - Amgen LtdOutcomes:
Myocardial infarction following index date; Stroke following index date; Ischemia-driven arterial revascularisation following index date; Cardiovascular death; Coronary heart disease death; Death from all causes; Composite of myocardial infarction, stroke, ischemia-driven arterial revascularisation, all-cause death following index date; Composite of myocardial infarction, stroke, ischemia-driven arterial revascularisation, cardiovascular or coronary heart disease death following index date; Lipid measurements following index date; Prescribing records of lipid-lowering-therapies, including statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors, bempedoic acid
Description: Lay Summary
Heart disease is the leading cause of death and disability the UK and globally. High blood cholesterol is a significant risk factor for developing heart diseases and high LDL (âbadâ) cholesterol is associated with increased risk of stroke and heart attack. In the UK, around 7.6 million people are living with heart disease each year - with an ageing and growing population, we could see these numbers rise still further. Recent advances in medicine, there are treatments now available to substantially lower levels of bad cholesterol in patients with heart disease and preventing them to have stroke and heart attack in the future. These medical treatments also provide an opportunity to help patients to control their bad cholesterol levels and preventing them to have heart disease. The aim of the study is to look at how many patients have these risk factors for heart disease and bad cholesterol, find out more about them, their characteristics, their levels of bad cholesterol, how they are treated and how many develop heart disease. We will use the CPRD database linked to Hospital Episode Statistics Admitted Patient Care (HES APC) data to look at how many patients may develop heart disease, and the impact of this problem to patients and the healthcare system. Our findings will help the government to decide about research priorities and may inform policies to reduce this public health problem.
Technical SummaryCardiovascular disease (CVD) is the leading cause of death and disability in the UK, it has significant adverse effects on patients and puts substantial strain on our healthcare system. High levels of low-density lipoprotein cholesterol (LDL-C) are associated with increased risk of major adverse cardiovascular events (MACE). There are lipid lowering therapies (LLT) now available to substantially lower LDL-C levels in patients with CVD and reduce risk of MACE. Patients without prior cardiovascular events, having established risk factors and elevated LDL-C may also benefit from intensive LLT. The aim of the study is to estimate the prevalence of high-risk pre-cardiovascular-event population in the real world, characterize the high-risk population, and examine the incidence of MACE using the CPRD databases with HES APC data.
High-risk patients (those with coronary artery disease, cerebrovascular disease, peripheral arterial disease, diabetes mellitus with microvascular complications or chronic insulin use), elevated LDL-C and other risk factors (e.g., chronic kidney disease, cigarette smoking) will be selected for the prevalence calculation. Prevalence for each calendar year will be estimated by counting the number of high-risk patients divided by the population in CPRD database. Descriptive statistics will be used to study characteristics of patients and their LLT patterns.
HES APC data will be used to determine hospitalisations and the MACE outcomes and Office of National Statistics (ONS) Death Registration data will be used for the cause of death (cardiovascular death, coronary heart disease death). Incidence of each individual cardiovascular event, mortality event and the defined composite endpoints will be calculated by counting the number of incident cases of each event/composite across the study period divided by the population at risk.
Evidence generated from this study will provide valuable information on the burden of CVD for the National Health Service (NHS) and other policymakers on research priorities and policy initiatives.
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Examining mental health outcomes, multimorbidity, and healthcare utilisation in Neurofibromatosis type 1 (NF1) and NF2-related schwannomatosis (NF2, formerly Neurofibromatosis type 2): a matched cohort study in England — Darren Ashcroft ...
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Examining mental health outcomes, multimorbidity, and healthcare utilisation in Neurofibromatosis type 1 (NF1) and NF2-related schwannomatosis (NF2, formerly Neurofibromatosis type 2): a matched cohort study in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-13
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Thomas Wright - Corresponding Applicant - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Shruti Garg - Collaborator - University of Manchester
Siddharth Banka - Collaborator - University of ManchesterOutcomes:
⢠Incidence of psychiatric diagnoses, including attention deficit hyperactivity disorder (ADHD), autism spectrum disorders (ASD), depression, anxiety disorders, obsessive-compulsive disorder (OCD), feeding or eating disorders, personality disorders, post-traumatic stress disorder (PTSD), bipolar affective disorder, schizophrenia, severe mental illness (SMI), dementia, alcohol and drug misuse.
⢠Prevalence of ASD and ADHD.
⢠Incidence of self-harm.
⢠All self-harm episodes (i.e., including first and subsequent recorded episodes; i.e., self-harm repetition).
⢠Incidence of prescriptions of psychotropic medications with sub-categories including antidepressants, benzodiazepines, antipsychotics, and medications used for dementia, ADHD, and ASD.
⢠All prescriptions of psychotropic medications with sub-categories (i.e., including the first and subsequent prescriptions).
⢠Incidence of prescriptions of medication as categorised by BNF chapters.
⢠All prescriptions of medications, as categorised by BNF chapters.
⢠Incidence of primary care referrals to mental health services.
⢠Incidence of psychiatric inpatient care.
⢠Incidence and/or prevalence of phenotypes of individual conditions, comorbidities and multimorbidity (conditions selected based on clinical association with NF1 or NF2, core conditions, diseases in the Quality and Outcomes Framework (QOF) and âLong Term conditionsâ (LTC) as defined by the NHS).
⢠Cause and age of death (all-cause and cause-specific mortality categorised using ICD-10 chapters across the full range).
⢠Incidence of primary care consultations.
⢠Incidence and primary diagnosis for inpatient and day-case hospital admissions.
⢠Incidence and speciality of outpatient hospital consultations.Incidence for each outcome will be determined on monthly, quarterly, or yearly period, stratified by age group, sex, ethnicity, and patientsâ residential neighbourhood-level IMD quintiles. Survival analysis techniques that account for varying person-time at risk and competing risks will be used to calculate cumulative incidence (absolute risk). Cox regression models will be used to model hazard ratios proportional hazard ratios (relative risks).
Description: Lay Summary
Neurofibromatosis type 1 (NF1) and NF2-related schwannomatosis (NF2, previously called Neurofibromatosis type 2) are rare genetic conditions that both cause benign nerve growths, various health problems and reduced life expectancy. Individuals with NF1 often experience difficulties with learning, social interaction and communication. In research studies, autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) are commonly diagnosed or suspected following screening tests. Surveys undertaken with individuals with NF1 or NF2 often report symptoms of anxiety, depression, and stress. It is not clear how often mental health conditions are diagnosed and treated among individuals with NF1 or NF2 within the NHS.
We will study all individuals diagnosed of NF1 and NF2 as recorded in their GP or hospital record. We will determine how common NF1 and NF2 are diagnosed. We will examine how often these individuals are diagnosed with mental health conditions and prescribed related medication. We will make comparisons between individuals with and without NF1 or NF2. We will look at how these and other conditions occur over time and the causes of deaths. Finally, we will study how often individuals with NF1 or NF2 use healthcare within the NHS (including how often people see their GP and the reasons and frequency of hospital admissions and outpatient appointments).
Working with our Patient and Public Involvement and Engagement partners, we will share our findings widely and make recommendations relevant for health and social care, education, and employment services. Our study will provide a framework for other rare conditions.
Technical SummaryNeurofibromatosis type 1 (NF1) and NF2-related schwannomatosis (NF2, formerly Neurofibromatosis type 2) are rare genetic conditions previously considered analogous. NF1 is characterised by cutaneous features, neurofibromas, optic pathway gliomas, variable learning difficulties and elevated malignancy risk. NF2 is considerably less common and causes bilateral vestibular schwannomas, meningiomas and spinal ependymomas. Small studies and questionnaire-based research report adverse physical and mental health outcomes and excess mortality risk in both conditions. No population-based studies have used linked primary care, secondary care and mortality datasets to investigate this further.
Our study population will consist of individuals registered with a CPRD Aurum contributing practice with a diagnosis of NF1 or NF2 recorded in their primary or secondary care record. A comparator group of unaffected individuals will be matched on age, sex and registered GP. Most diagnostic codes do not distinguish between NF1 and NF2, although separate groups will be determined using condition-specific supporting codes. Related approaches were used to establish Denmarkâs NF1 registry and examined cancer outcomes using Hospital Episode Statistics.
Three phases of study are planned. Phase 1 will investigate the prevalence and incidence of NF1 and NF2. Phase 2 will investigate mental health outcomes and psychotropic medicine prescriptions from 2000 onwards. Phase 3 will investigate common and condition-specific phenotypes across a life course and cause-specific mortality. Phase 3 will include a nested healthcare utilisation study from 2008 onwards. Outcomes will be stratified by sex, age, ethnicity and Index of Multiple Deprivation quintiles. Cumulative incidence (absolute risk) will be calculated using survival analysis techniques accounting for varying person-time at risk and competing risks. Relative risks will be estimated by Cox regression models.
Working with our Patient and Public Involvement and Engagement (PPIE) partners, we will creatively disseminate our findings, offering cross-sector recommendations. Our study will provide a framework for examining other rare conditions.
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Safety of ciprofloxacin and risk of suicidality: a case control study in UK primary care using the Clinical Practice Research Datalink. — Richard Partington ...
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Safety of ciprofloxacin and risk of suicidality: a case control study in UK primary care using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-25
Organisations:
Richard Partington - Chief Investigator - Keele University
Sara Muller - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
James Bailey - Collaborator - Keele UniversityOutcomes:
Suicide risk (i.e. completed, attempted suicide or moderate-high suicide risk)
Description: Lay Summary
Ciprofloxacin is an antibiotic used to treat lots of common infections. Like all medicines, it can cause unwanted effects. One of these effects is thought to be an increased risk of suicide.
This year, a patient with no previous mental health problems completed suicide after being prescribed ciprofloxacin. It was felt the doctor who prescribed ciprofloxacin had not warned the patient of this potential risk.
Currently the evidence for whether ciprofloxacin increases the risk of suicide is mixed; some studies found an increased risk, but others didnât. This lack of certainty is because completed suicide is very rare, and many other factors affect a personâs risk, for example, the infections that ciprofloxacin is used to treat can cause people to feel unwell or to become confused. This might also increase the risk of suicide.
We will compare patients with a record of completed suicide, attempted suicide, or those who have a medium to high risk of suicide, to people without any record of these things to find out:
⢠whether they are more likely to have received a prescription for ciprofloxacin in the six months prior.
⢠whether there any groups or people at higher risk of suicide when taking ciprofloxacin.This research will benefit patients and the public by improving the safety of prescribing. This could either involve removing or restricting access to ciprofloxacin if a link is found, or alternatively widening access to it if no association is found, ensuring patients can receive the most effective treatment.
Technical SummaryIn English General Practices, 30,000 to 50,000 items of oral ciprofloxacin are prescribed monthly to treat a wide variety of bacterial infections, particularly lower respiratory tract infections (LRTI), urinary tract infections (UTIs), and prostatitis.
However, the use of ciprofloxacin is associated with several adverse events, many of which are atypical in nature. Specific alerts from the Medicines and Healthcare Products Regulatory Authority (MHRA) are in place warning of the risk of tendinopathy and rupture, aortic aneurysm and dissection, heart valve regurgitation, and long lasting or potentially irreversible severe disabling side effects.
An increased risk of suicidal behaviour following treatment with ciprofloxacin has been recognised as a potential adverse event in licensing documents. Following the death of a patient, a report to prevent future deaths was sent to the MHRA and the manufacturers of the medication in 2023.
Ciprofloxacin is a drug which, despite its unusual and potentially severe list of side effects, continues to be used in primary care in the UK. As it is suspected to be associated with an increased risk of suicidal behaviour, it is important to establish this aspect of its safety.
Using linked CPRD Aurum, Hospital Episodes Statistics, and death registration data from those aged â¥18 years diagnosed with a LRTI, UTI or prostatitis, we will:
1. Determine whether patients who have displayed suicidal behaviour or have completed suicide, have an increased odds of having received a prescription for ciprofloxacin in the preceding 1, 2, 4, 8, 12 and 26 weeks.
2. Understand subgroups of the population that might be at higher risk of suicidality after prescription of ciprofloxacin.The prevalence of prescriptions of ciprofloxacin in cases (suicidal behaviour or complete suicide) and will be compared to controls using conditional logistic regression. Interactions will be fitted to investigate potential subgroups of interest.
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Investigating adverse mental health outcomes related to glucagon-like peptide-1 receptor agonists: target trial emulation using interlinked primary and secondary healthcare records — Roger Webb ...
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Investigating adverse mental health outcomes related to glucagon-like peptide-1 receptor agonists: target trial emulation using interlinked primary and secondary healthcare records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-01
Organisations:
Roger Webb - Chief Investigator - University of Manchester
Maja Radojcic - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Faraz Mughal - Collaborator - Keele University
Martin Rutter - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of ManchesterOutcomes:
Primary outcome â self-harm (defined according to NICE as âan intentional act of self-poisoning or self-injury, irrespective of the motivation or apparent purpose of the actâ, including suicide attempts and self-harm episodes that are evidently not suicidal).
Secondary outcomes â suicidal ideation, suicide (death), diagnoses and symptoms of anxiety and depression.
Negative control outcome â appendectomy.Description: Lay Summary
Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are a relatively new class of medications approved for managing increased blood sugar levels and obesity. While the benefits of these drugs in treating these and related health problems have been well-established, recently some concerns have arisen regarding their potential impact on mental health. The European medicines regulatory body recently issued a statement on reviewing data on GLP-1RAs and their risk of suicidal thoughts and thoughts of self-harm. We aim to examine this safety warning by investigating the mental health safety of these medications among patients taking them for increased blood sugar levels or obesity treatment in England. Our study design will mirror the robust methodology employed in high-quality studies establishing how well GLP-1RAs work, aligning with UK guidelines for treating these conditions. Importantly, we will evaluate the risk of self-harm, suicidal thoughts, suicide, anxiety, and depression in patients both with and without a pre-existing history of mental health problems before initiating these medications. This approach will address a common limitation of clinical trials of excluding individuals with mental health concerns. However, following the medication approval, people with mental health concerns have the same chance to receive the same medication as people without mental health problems. Overall, this study will provide important findings about the safety profile of GLP-1RAs, guiding optimal use in clinical practice and enhancing our understanding of their impact on mental health.
Technical SummaryWe will utilise interlinked primary and secondary healthcare records to emulate the safety target trial, mirroring the design of pivotal GLP-1RA efficacy trials (obesity STEP 1 and type 2 diabetes SUSTAIN 2 trials), while aligning with the latest National Institute for Health and Care Excellence (NICE) guidelines for treating obesity and type 2 diabetes. Our approach involves two phases of planned work, one focusing on obesity (mono) treatment and the other on type 2 diabetes, examining the safety of GLP-1RAs within various dual and triple treatment contexts. The obesity trial encompasses four arms: no pharmacological intervention, orlistat, liraglutide, and semaglutide. For type 2 diabetes, we will emulate two five-arm trials, including dual treatment arms with metformin and sodium/glucose cotransporter-2 inhibitors (SGLT2Is); metformin and dipeptidyl peptidase-4 inhibitors (DPP-4Is) pioglitazone, or sulfonylureas; any dual combination of SGLT2Is, DPP-4Is, pioglitazone, or sulfonylureas; metformin and GLP-1RAs; and GLP-1RAs with either SGLT2Is, DPP-4Is, pioglitazone, or sulfonylureas. The triple treatment arms will involve combinations of metformin, SGLT2Is, and either DPP-4Is, pioglitazone, or sulfonylureas; any triple combination of SGLT2Is, DPP-4Is, pioglitazone, or sulfonylureas; metformin, GLP-1RAs, and either SGLT2Is, DPP-4Is, pioglitazone, or sulfonylureas; and any triple combination of GLP-1RAs with SGLT2Is, DPP-4Is, pioglitazone, or sulfonylureas; and insulin. We will report the incidence of mental health outcomes in each group and analyse safety outcomes using both intention-to-treat and per-protocol approaches. Inverse probability weighting based on propensity scores will address non-random assignment and adherence issues. Cox proportional hazard regression will assess treatment hazards, and subgroup analyses will provide outcome risks stratified by various factors. This study will generate important findings about the safety profile of GLP-1RAs, by enhancing our understanding of their effects on patientsâ mental health and thereby guiding their optimal utilisation in routine clinical practice.
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Feasibility study of the risk and long-term outcomes of acute kidney injury among chronic kidney disease patients undergoing cardiopulmonary bypass procedure in the UK — Kyaw Joe Sint ...
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Feasibility study of the risk and long-term outcomes of acute kidney injury among chronic kidney disease patients undergoing cardiopulmonary bypass procedure in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-28
Organisations:
Kyaw Joe Sint - Chief Investigator - Alexion Pharmaceuticals, Inc ( USA )
Kyaw Joe Sint - Corresponding Applicant - Alexion Pharmaceuticals, Inc ( USA )
Francesca Gatta - Collaborator - AstraZeneca GmbHOutcomes:
Acute kidney injury; AKI severity; CKD progression; dialysis; kidney transplant; all-cause mortality; hospitalization, A&E admission, outpatient visits.
Description: Lay Summary
Patients with chronic kidney disease (CKD) undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at high risk for cardiac surgery associated acute kidney injury (CSA-AKI). Using the primary care CPRD database and linking it with hospital and mortality records, this feasibility study aims to determine the feasibility of determining acute kidney injury among patients undergoing cardiopulmonary bypass procedures and long-term outcomes of CKD progression, dialysis, kidney transplant, mortality, hospitalizations, A&E admissions, and outpatient visits.
If acute kidney injury and renal outcomes are able to be identified in the feasibility study, a future study will be planned to estimate 1) the incidence of AKI following CPB; 2) the demographic and clinical predictors of developing AKI; and 3) the short-term and long-term outcomes of patients who developed and did not develop AKI post-CPB. The future study will identify variables such as age, pre-existing conditions, and procedural factors, which may correlate with the onset of AKI. Furthermore, outcome measures, including subsequent renal function, duration of hospitalization, and mortality, will be analysed to understand the long-term outcomes of AKI post-CPB. The study will help understand the patient journey and medical need of patients experiencing acute kidney injury after CPB procedure in England and Wales.
Technical SummaryThis feasibility study aims to assess the feasibility of determining acute kidney injury (AKI) and outcomes among patients undergoing surgeries involving cardiopulmonary bypass (CPB) by utilizing the CPRD primary database linked with hospital episode statistics (HES) and ONS mortality data. AKI is recognized for its clinical significance due to its common occurrence post-CPB and its association with increased morbidity and mortality. The CPRD, anonymised primary care records, and linkage with HES facilitates a comprehensive examination of patient medical histories.
Based on CPRD GOLD primary care data of patients undergoing CPB, not limited to patients with CKD from 2010 to 2022 results in 16,411 procedures from 14,036 patients. However, the number of patients with available renal function data (serum creatinine and eGFR) is limited near time of surgery (about 4-6% around the week of surgery) and low numbers of records of dialysis. The protocol seeks to link the CPRD primary care data with the HES and ONS data to assess acute kidney injury and outcomes including CKD progression, dialysis, hospitalizations, and mortality.
For the feasibility study with linked data, descriptive statistics such as mean, standard deviation, interquartile range, minimum, and maximum for the number of events and count and percent for the occurrence of events will be analyzed. Only patients with CKD stage 3 or 4 and without stage 5 or ESRD in the 6 months prior to surgery will be included in the study.
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Incidence, early disease trends, treatment effectiveness and risk factors associated with severity for patients with sickle cell — Jianhua Wu ...
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Incidence, early disease trends, treatment effectiveness and risk factors associated with severity for patients with sickle cell
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-18
Organisations:
Jianhua Wu - Chief Investigator - Queen Mary University of London
Paris Baptiste - Corresponding Applicant - Queen Mary University of London
Harriet Larvin - Collaborator - Queen Mary University of London
Manh Thang Hoang - Collaborator - Queen Mary University of LondonOutcomes:
Sickle cell disease incidence; sickle cell trait incidence; sickle cell related hospitalisation; all-cause mortality; stroke; heart failure; chronic kidney disease; myocardial infarction; pneumonia
Description: Lay Summary
Sickle cell disease (SCD) is an inherited condition that affects red blood cells. It is caused by unusual shaping of red blood cells which can cause blockages leading to severe pain and other health conditions. SCD is most common in people from Black African or Black Caribbean family origin but can affect people of other ethnic groups. The only cure for sickle cell is a stem cell or bone marrow transplant but these are rarely carried out as they are high risk procedures. Instead, people with severe sickle cell disease often have to manage pain and symptoms using medications.
It is believed that around 15,000 people in England have SCD with much more having sickle cell trait (SCT), meaning they carry the gene which can be passed on to their children. However, evidence to support this is dated and due to the growing population of Black and Mixed ethnicity individuals in the UK this is likely to be more. To date much of the evidence exploring how effective medications are at managing SCD comes from the US. In addition to this, it is unknown why some people with SCD suffer more than others and have poorer outcomes. This study aims to give an up-to-date estimate of the number of patients living with sickle cell in the UK and explore if specific characteristics or clinical events lead to some patients having poorer outcomes. Finally, it will explore how effective medications are at managing the disease in the UK.
Technical SummarySickle cell disease (SCD) refers to a group of inherited blood disorders. It causes painful episodes (crises) and other comorbidities, with progression of the disease often heterogeneous. There is a fundamental knowledge gap in prediction of whom the disease is most severe; if filled this could transform the outcomes of patients with SCD. Using CPRD GOLD and Aurum this study will provide up-to-date estimates of the incidence of SCD and sickle cell trait (SCT) and assess the association with socio-economic status through linked data on deprivation. Using death dates recorded in CPRD we will additionally describe temporal trends of survival of SCD and SCT.
To provide insight into disease severity related to sickle cell crises, we will use linked hospital data to model sickle cell related hospital stays using a growth mixture model. A logistic regression model will be used to identify factors associated with most severe trajectories.To explore disease progression of comorbidities, we will use process mining methods to identify clinical pathways of patients with SCD and SCT compared to the general population and identify factors associated with disease severity. This will help target therapeutic strategies to specific patient groups, reducing the incidence of stroke among other conditions and premature mortality. In addition, determining the risk factors associated with disease severity will also help targeting these individuals for delayed disease progression.
There is a scarcity in large-scale population-based studies that provide high-resolution insights into the effects of hydroxyurea treatment for SCD management. Therefore, our final aim will compare patients with SCD who received a prescription for hydroxyurea to those with SCD who have never received a prescription for this medication. We will use a propensity-scoreâmatched Cox regression model to estimate the effects of this medication on all-cause mortality and other cardiovascular outcomes.
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Effectiveness and safety of rivaroxaban vs apixaban in patients with Atrial Fibrillation and Peripheral Artery Disease — Samy Suissa ...
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Effectiveness and safety of rivaroxaban vs apixaban in patients with Atrial Fibrillation and Peripheral Artery Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-05
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Corresponding Applicant - McGill University
Antoine Pariente - Collaborator - Inserm U1219 Bordeaux Population Health Research Center - Team AHeaD
Loubna DARI - Collaborator - McGill University
Sarah Beradid - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
The primary effectiveness outcomes will be:
-a composite of hospitalisation with an incident ischaemic stroke, transient ischaemic attack (TIA), and systemic embolism (SE) other than acute limb ischemia (ALI).
-major limb event (MALE) defined as a hospitalisation for an ALI, major amputation (above the ankle), minor amputation or lower limb revascularization.
The primary safety outcome of interest will be a hospitalisation for bleeding or a related death.
Secondary outcomes will include:
- Major cardiac event (MACE) defined as a composite of hospitalisation for myocardial infarction, stroke, and cardiovascular death.
- A composite of hospitalisation with an incident ALI or major amputation.
ICD-10 codes are listed in Appendix 1. Corresponding procedure codes in HES are listed in Appendix 1.Description: Lay Summary
Atrial fibrillation (AF) is a heart condition that increases the risk of stroke. To reduce this risk, individuals with AF are prescribed blood-thinning medications called anticoagulants such as warfarin or the more recently approved direct oral anticoagulants (DOACs). DOACs, including dabigatran, rivaroxaban, edoxaban, and apixaban, are preferred nowadays because of their similar efficacy and their greater ease of use. Many individuals with AF can also present with peripheral artery disease (PAD), in which the leg arteries become narrowed or blocked, affecting blood flow to the legs. PAD can lead to amputations and also increases the risk of stroke. Recent research has suggested that rivaroxaban, at lower dose than used in AF, might be particularly helpful for people with PAD. However, people with both PAD and AF were not studied since these patients need higher dose of DOACs.
Technical Summary
Therefore, we will compare the safety and effectiveness of rivaroxaban and apixaban, another DOAC, in individuals who have both AF and PAD. We will examine how frequently they experience stroke, leg problems such as amputations, and bleeding events. This information will assist doctors in determining if rivaroxaban is most suitable for these patients. It could also lead to improved treatment recommendations for these leg artery issues and enhance the overall health of individuals coping with these conditionsAlthough DOACs are at least as effective and safe compared to VKAs in patients with AF and PAD, little is known about whether some DOACs are more effective and safer than others in this population. Besides, recent trials demonstrated lower cardiovascular and limb events with low dose of rivaroxaban in patients with PAD. Thus, we will conduct a population-based cohort study to determine the effectiveness and safety of rivaroxaban vs apixaban in patients with both AF and PAD. This study will be conducted by linking the CPRD, the HES inpatient and ONS mortality databases. We will form a cohort of patients with non-valvular AF (NVAF) and history of PAD, newly treated with rivaroxaban or apixaban between 2013 and 2021. All patients will be followed until one of the outcomes, death, oral anticoagulant discontinuation/switches, end of registration with the general practice, or end of the study period. Primary effectiveness outcomes will be a composite of stroke, transient ischaemic attack, and systemic embolism other than acute limb ischemia (ALI), and a composite outcome of a major limb event (MALE) defined as a major amputation, minor amputation, ALI, revascularization. The primary safety outcome will be major bleeding or death from bleeding. Secondary outcomes will include major cardiac events (MACE), a composite of a hospitalization for myocardial infarction, stroke, or cardiovascular death, and ALI or major amputation. We will use Cox proportional hazards models to estimate hazard ratios and 95% confidence intervals of the outcomes of interest associated with rivaroxaban compared with apixaban. In secondary analyses, we will perform stratified analyses based on patientsâ characteristics, stage of PAD and DOAC dosage. We will use a propensity score (PS)-based fine stratification and weighting to control for potential confounding. Several sensitivity analyses will be performed to assess the robustness of our results.
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Infections and anxiety, depression, severe mental illness, or suicide and self-harm: population-based matched cohort study — Charlotte Warren...
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Infections and anxiety, depression, severe mental illness, or suicide and self-harm: population-based matched cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-04
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Morton - Collaborator - Queen Mary University of London
Georgia Gore-Langton - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Naaheed Mukadam - Collaborator - University College London ( UCL )
Seena Fazel - Collaborator - University of OxfordOutcomes:
Primary outcomes: anxiety; depression; severe mental illness (SMI) (schizophrenia, bipolar disorder, other psychoses); suicide and self-harm;
Secondary outcomes: schizophrenia; bipolar disorder; other psychoses; post-traumatic stress disorder; self-harm;
Description: Lay Summary
One in six adults in the UK has a common mental health condition such as anxiety or depression. Anxiety is where people feel worried or fearful. Depression is where people feel sad. These conditions are more common in women and have a major impact on quality of life. The causes or triggers of mental health conditions are not fully understood. Some research suggests that infections may affect mental health. However, we do not know whether specific infections are linked to particular mental health conditions. We also donât know which groups are most at risk.
In our study, we will compare the risk of mental health conditions between people with and without infections. We will account for differences between people in factors such as age, sex, and physical health. We will explore whether some groups of people are at higher risk of mental health conditions following infections than others.
If we find a link between infections and mental health, this could impact on care. For example, we could offer mental health support to people when they have an infection. Preventing infections with vaccines might help mental health. Treating infections early could also improve people's mental health.
Technical SummaryWe aim to investigate relationships between infections (sepsis, lower respiratory tract, urinary tract skin/soft tissue, gastroenteritis; positive control exposures: meningitis, encephalitis) and mental health conditions (anxiety, depression, severe mental illness [SMI], suicide/self-harm). We will conduct separate matched cohort studies of adults (â¥18years) in CPRD Aurum for each infection and mental health condition pair. Evidence of associations between infections and mental health conditions, would indicate potential benefits of targeted mental health screening following infections, and potentially suggest more active control of inflammation and lifestyle advice during infection, with potential for consequent improvement in mental health conditions.
Individuals will be eligible from the latest of: study start (1997); 18th birthday; or one year after practice registration. Individuals will be eligible until the earliest of: study end (latest available data); death; registration end; or no further data collected from practice. We will exclude individuals with records of relevant mental health conditions (varying by mental health outcome) before start of follow-up.
We will match (age, sex, practice), without replacement, individuals with infections to individuals without infection (1:5) on infection date. Individuals will be followed until: no longer eligible; mental health outcome; or diagnosis suggesting an alternative cause for outcome (e.g., organic depression/dementia for depression analyses; SMI for both depression/anxiety analyses). We will estimate confounder-adjusted hazard ratios (95%CI) using stratified Cox regression comparing mental health condition rates in infected to matched comparators. In secondary analyses, we will investigate whether the associations between infection and mental health conditions varies with time since initial infection or infection severity, and whether the associations are modified by age or sex.
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Systematic approaches to studying diseases in people: an Atlas of Diseases — Harry Hemingway ...
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Systematic approaches to studying diseases in people: an Atlas of Diseases
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-06
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Natalie Fitzpatrick - Corresponding Applicant - University College London ( UCL )
Alvina Lai - Collaborator - University College London ( UCL )
Amitava Banerjee - Collaborator - University College London ( UCL )
Ana Torralbo - Collaborator - University College London ( UCL )
Andrej Ivanovic - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Christopher Tomlinson - Collaborator - University College London ( UCL )
Johan Thygesen - Collaborator - University College London ( UCL )
Laura Pasea - Collaborator - University College London ( UCL )
Muhammad (Ashkan) Dashtban - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
For each disease we will estimate outcomes at 1 year:
Mortality, all cause and cause-specific
Hospital admissions, all cause and cause specificDescription: Lay Summary
Despite hospitals capturing vast amounts of data on their patients, healthcare systems in England know remarkably little about which patients have which diseases, in which combinations, and what the outcomes are for patients. When a doctor sees a patient, (s)he will record information about the patientâs disease in a computer system using a series of codes. However, diseases are not coded in the same way in general practice and hospitals, making research challenging. Recent opportunities for accessing national hospital data for patients stored electronically, in a safe and secure way, has allowed researchers to generate entirely new information about all diseases. We will build on research carried out with national data by using data collected on patients with one or more diseases in general practice, linked to hospital data. Our research aims are to use the coding system adopted in general practice to define diseases to help researchers understand whether this form of coding captures additional diseases compared to codes used in hospitals; and analyse data for diseases defined used the GP coding system to provide novel information about how often diseases occur, which diseases occur together, what outcomes are for patients, and use of medications and procedures. This new body of knowledge will be made available to patients, doctors, researchers and people involved in guiding healthcare decisions in a âDisease Atlasâ to aid understanding of what diseases patients have, or are at risk of, so healthcare needs can be addressed and adopted into policy to guide treatment.
Technical SummaryBackground: Systematic approaches to studying diseases in populations have focused on common diseases (eg Global Burden of Diseases) but have not considered less common and rare diseases, nor considered how diseases co-occur in people or polypharmacy.
Objectives: To develop a Disease Atlas across linked primaryâsecondary care data.
Methods: as in previous CPRD approved protocols (12_153, 16_022 and 20_074), we will use all patients, all ages with up to standard linked data. A participant will enter a disease cohort on the date of first occurrence of a SNOMED-CT disorder term or an ICD-10 disease term. From that date and within this period, we will follow back to a patients first record (for co-occurrence), and follow forward for 365 days for death and hospitalisations. We will estimate prescribed drugs within 12 months of the first record of disease. Specifically we will define diseases using SNOMED-CT disorder terms in UK primary care alone or in combination with ICD-10 in HES APC and A&E. We will estimate estimates from primary care data mirroring those previously generated in secondary care data in 56m population. For each disease these estimates include frequency, co-occurrence, prognosis and use of medications and procedures. For diseases which are sufficiently common we will develop and validate parsimonious prognostic models. We will determine the extent to which SNOMED-CT data offers differences in understanding beyond ICD-10 comparing for example in disease resolution: to what extent does SNOMED-CT capture additional diseases, beyond those in ICD-10? We will also investigate patterns of disease co-occurrence: how do they differ among people who have and do not have hospital data?
Outputs: As well as publishing papers in peer-reviewed journals, we will work with stakeholders (patients, clinicians, policymakers) on the development, testing and launch of a public-facing website to communicating relevant information from the Atlas.
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Characterization of the Alzheimer's disease population within England, including sub-group analysis of Alzheimer's disease patients with Down syndrome. — Ana Sofia Maciel Afonso ...
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Characterization of the Alzheimer's disease population within England, including sub-group analysis of Alzheimer's disease patients with Down syndrome.
Datasets:GP data, All study cohorts will have baseline assessment of demographics, diagnoses, procedures, medications and HCRU. The outcomes to be measured include descriptions of demographics (e.g. age at index, sec at index, region division at index, race/ethnicity at index), specific diagnosis (e.g. as Alzheimerâs disease, mild cognitive impairment, asthma/COPD, sleep apnea, glaucoma, atrial fibrillation, chronic kidney disease, etc.) and medications (e.g. Blood glucose lowering drugs, excluding insulin , Antithrombotic agents, etc.) and HCRU (visits to GP with linkage to HES). Please note that complete listing of diagnosis, procedures, medications and HCRU were attached with this submission as additional documents.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-06
Organisations:
Ana Sofia Maciel Afonso - Chief Investigator - Eli Lilly & Co Ltd - US Headquarters
Ana Sofia Maciel Afonso - Corresponding Applicant - Eli Lilly & Co Ltd - US Headquarters
Caroline Casey - Collaborator - Eli Lilly and Company Ltd. (UK)
Krista Schroeder - Collaborator - Eli Lilly & Co Ltd - US Headquarters
LUCY MITCHELL - Collaborator - Eli Lilly and Company Ltd. (UK)Outcomes:
All study cohorts will have baseline assessment of demographics, diagnoses, procedures, medications and HCRU. The outcomes to be measured include descriptions of demographics (e.g. age at index, sec at index, region division at index, race/ethnicity at index), specific diagnosis (e.g. as Alzheimerâs disease, mild cognitive impairment, asthma/COPD, sleep apnea, glaucoma, atrial fibrillation, chronic kidney disease, etc.) and medications (e.g. Blood glucose lowering drugs, excluding insulin , Antithrombotic agents, etc.) and HCRU (visits to GP with linkage to HES). Please note that complete listing of diagnosis, procedures, medications and HCRU were attached with this submission as additional documents.
Description: Lay Summary
Alzheimer's Disease is the most prevalent cause of neurodegenerative disease around the world, accounting for 60-80% of dementia cases. With an aging population and disease modifying treatments still in development, the prevalence of Alzheimerâs Disease is projected to reach 12.7 million by 2050 and is rapidly becoming a global burden. Alzheimerâs disease within the United Kingdom is not well understood in the general population as well as vulnerable populations such as down syndrome. This makes it difficult to determine whether clinical studies involving patients taking Alzheimerâs medication accurately reflects the real-world population with Alzheimerâs Disease. This knowledge would have important implications for patients, families, clinicians, researchers, and policy makers.
Technical Summary
The overall aim of this study is to characterize the risk profile â including factors such as ethnicity, age, sex, health status and treatment â of Alzheimerâs disease in patients from the general population and those with Down Syndrome in the United Kingdom. Data will be assessed using electronic health records from the Clinical Practice Research Datalink, where participants will be determined and divided into groups based on their Alzheimerâs diagnosis or treatment. This study is a retrospective cohort study that aims to address existing gaps in Alzheimerâs disease identification by describing patient risk profile. Data analysis will be performed using cohort attrition tables and assessments will be made on the characteristics of the patients with Alzheimerâs disease.Alzheimerâs disease (AD) within the UK (United Kingdom) population is poorly characterized. This makes conclusions regarding the representation of UK clinical trial populations into real world difficult. To address this evidence gap, this study is designed to characterize patients with newly diagnosed AD using Clinical Practice Research Datalink (CPRD) and CPRD-linkages, with the overarching aim to better understand the AD population In England, and additionally the population with Down-syndrome (DS) and AD. This study is limited to England only due to Hospital Episode Statistics (HES) coverage limitations. The primary objective of this study is to characterize demographics, diagnoses, procedures, medications and Health care resource utilization (HCRU) in newly diagnosed AD patients aged 60+, using two different AD disease-based algorithms and one medication-based cohort. The secondary objective is the same but for the subpopulations with DS.
CPRD Aurum data will be used to select eligible patients from the primary healthcare setting, with data analysis conducted to describe patient demographics and clinical characteristics associated with AD. Primary care-based treatments will be assessed as well as estimating the HCRU incurred by these patientsâ following diagnosis. Additional HES datasets will be used to select eligible patients that are diagnosed within the secondary care setting, and CPRD Ethnicity Records will be used to better understand the ethnic diversity of AD patients. All study cohorts will have baseline assessment of demographics, diagnoses, procedures, medications and HCRU. The results from this study will increase the knowledge and understanding of healthcare professionals and the public, with regards to the typical AD patient in England. These data will help to profile AD and AD-DS patients, in the hope that they will be recognised and receive an accurate diagnosis more efficiently in the future. Healthcare professionals, patients and caregivers will benefit from the results of this study.
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Macrolide antibiotic use and the risk of allergic reactions, and allergic and autoimmune diseases: cohort and nested-case control analyses — Susan Jick ...
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Macrolide antibiotic use and the risk of allergic reactions, and allergic and autoimmune diseases: cohort and nested-case control analyses
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-26
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Cutaneous allergic reactions; anaphylaxis; Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS/TEN); asthma; atopic dermatitis; allergic rhinitis; food allergy; rheumatoid arthritis, psoriasis, multiple sclerosis, systemic lupus erythematosus
Description: Lay Summary
Macrolides are a type of antibiotic that include erythromycin, clarithromycin, and azithromycin. They are commonly used by adults and children to treat some common infections. This type of antibiotic is known to cause allergic reactions in some patients, but it is not known how often they happen or if certain patients are more likely than others to have a reaction to these drugs. In this study we will measure how often macrolide allergic reactions happen overall and by type (such as rashes, difficulty breathing). We will compare how often people using macrolides have allergic reactions compared to people using other commonly used antibiotics (amoxicillin, quinolones, trimethoprim, and nitrofurantoin).
Technical Summary
We will also look at whether macrolides affect whether patients develop allergic diseases (eczema, asthma, allergic rhinitis, food allergy) and autoimmune diseases (rheumatoid arthritis, psoriasis, multiple sclerosis, lupus) compared with other antibiotics.
This study will help patients and their doctors understand how often allergic reactions occur in people who take macrolide antibiotics, if some patients are more likely to have a reaction than others, and whether macrolides are more or less safe than other commonly used antibiotics.Macrolide antibiotics are one of the most common antibiotic classes used among adults and children worldwide. While drug allergies have been documented for macrolides, the epidemiology of macrolide allergy is unknown. Macrolide antibiotics have been associated with a variety of immunologic effects but have not been assessed as a risk factor for allergic or autoimmune disease.
This study will report rates of and risk factors for allergic reactions to macrolide antibiotics compared to other commonly used antibiotics among treatment-naïve patients and assess the association between macrolide exposure and incident allergic and autoimmune diseases among new users.
Objective 1: Among a population of antibiotic users (erythromycin, clarithromycin, azithromycin, amoxicillin, ciprofloxacin, ofloxacin, trimethoprim, nitrofurantoin) whose CPRD records began at birth (treatment-naïve), we will calculate incidence rates (IRs) and 95% confidence intervals (CIs) for allergic reactions for each study antibiotic. We will calculate incidence rate ratios (IRRs) with 95% CIs for each antibiotic type and class compared to users of ciprofloxacin. We will use HES APC to increase capture of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Objective 2: In patients with at least 3 years of registration before first antibiotic use (new users), we will conduct a nested case control study using conditional logistic regression to estimate odds ratios (ORs) with 95% CIs for each allergic and autoimmune disease outcome (atopic dermatitis, asthma, allergic rhinitis, food allergy, rheumatoid arthritis, psoriasis, multiple sclerosis, systemic lupus erythematosus) by specific antibiotic and class with unexposed patients as the common referent group.
For both objectives, we will use linked deprivation scores and rural versus urban residence to assess whether these factors are confounders of associations between macrolides and these outcomes.
This study will inform patients and clinicians on rates and risk factors for macrolide allergies and relative safety of macrolide antibiotics compared with other commonly used antibiotics.
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Rhythm control strategies in patients with heart failure and atrial fibrillation: Eligibility and long-term outcomes — Rosita Zakeri ...
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Rhythm control strategies in patients with heart failure and atrial fibrillation: Eligibility and long-term outcomes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-27
Organisations:
Rosita Zakeri - Chief Investigator - King's College London (KCL)
Rosita Zakeri - Corresponding Applicant - King's College London (KCL)
Chloe Bloom - Collaborator - Imperial College LondonOutcomes:
1. Proportion of patients with AF and HF eligible for early rhythm control.
2. Rates of all-cause mortality and CV hospitalisation in patients eligible for early rhythm control.
3. Rates of all-cause mortality and CV hospitalisation in patients undergoing ablation-based rhythm control versus pharmacological rate-control therapy.Description: Lay Summary
Many people with heart failure (HF) develop an abnormal heart rhythm, known as atrial fibrillation (AF). AF often causes breathlessness and lower life-expectancy in people with HF. Current treatment of AF involves slowing the heart rate with medication. If people have ongoing symptoms, we try to restore normal rhythm using special drugs or an ablation procedure. An ablation procedure involves passing thin tubes through blood vessels in the leg to the heart to create small burns that block electrical signals causing AF.
A recent clinical trial showed that restoring normal rhythm earlier, within 12 months of AF diagnosis, either with drugs or ablation, can reduce the risk of death. Only a few people in the trial had HF. Therefore, we will assess how many people there are with HF and AF in the population who could be eligible for early treatment. This information will be useful for planning healthcare services.
Secondly, ablation is better at restoring normal rhythm than drugs, but we donât know if ablation reduces deaths or hospital admissions in people with HF. This information would help patients and doctors better understand the risks and benefits of ablation when deciding on their treatment. We will compare rates of death and hospital admissions between people with AF and HF undergoing ablation compared with those receiving drugs. We will also study whether a patientâs gender or other medical conditions, such as diabetes or lung disease, might change the effects of AF ablation and should therefore be considered when planning treatment.
Technical SummaryThe EAST-AFNET4 trial suggested that early rhythm control improves outcomes in patients with AF. However, few patients in EAST-AFNET had HF. We will use primary and linked secondary care data to evaluate the proportion of patients with diagnostic codes for AF and HF in England between 2004-2024, who are eligible for early rhythm control and define the incidence of death and cardiovascular hospitalisations in this group.
Secondly, we will evaluate whether AF ablation is associated with better survival and lower hospitalisation rates than pharmacological rate control among patients with HF and AF. We will include patients who do not have an implanted cardiac device and those prescribed newer HF therapies, such as ARNI and SGLT2 inhibitors, for whom there is no high-quality evidence. To achieve similar treatment groups, we will calculate a high-dimensional propensity-score (hdPS) based on empirical variables across five dimensions (hospitalisations, procedures, diagnoses, prescriptions, laboratory values). Conditional Cox proportional hazards regression (stratified by matched-pair) will be used to compare the risk of each outcome in the hdPS weighted cohort. We will test additional models with biologically relevant investigator-selected covariates manually forced into the hdPS model, e.g. age, sex, use of antiarrhythmic and HF medications in the year before the index date (adjusted-matched model). A final model will include interaction terms to study effect modification between the exposure (ablation) and age, gender, time since first AF documentation and comorbidity burden.
This project will benefit patients by defining the generalisability of the EAST-AFNET trial and effect size of AF ablation in patients with HF in England, thereby filling an evidence gap needed to inform clinical practice guidelines and enable the design of future clinical trials to improve care for this population. By defining the size of the HF population eligible for ablation, this study will also support healthcare resource planning.
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Frailty and polypharmacy among adults aged 18 and above with cancer at the time of diagnosis — Annika Jodicke ...
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Frailty and polypharmacy among adults aged 18 and above with cancer at the time of diagnosis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-01
Organisations:
Annika Jodicke - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
Prevalence of frailty and polypharmacy, descriptive characteristics of people with cancer, 1 year mortality rates
Description: Lay Summary
Ageing is associated with an increment in vulnerability, also known as fragility, and the diagnosis of long-term conditions. Both can make people less able to cope and recover from physical illness or other stressful events. Long-term conditions require treatments, and the presence of several conditions into the same person leads to people taking several medicines concomitantly, also known as polypharmacy, which is particularly common among the elderly.
People who are diagnosed with a cancer and who are already taking multiple medications or live with frailty, may have a poorer chance of recovery and their treatments options may be limited. This study aims to better understand how common frailty and polypharmacy are among people diagnosed with different cancers, and if being frail has an impact on mortality in patients diagnosed with cancer.
Technical SummaryOBJECTIVE:
The aim of this study requested by the European Medicines Agency is to estimate the prevalence of frailty and polypharmacy at the point of diagnosis of selected cancers in people aged 18 and above and to describe their characteristics.STUDY POPULATION:
The study population will include all individuals aged 18 years and above with a primary diagnosis of cancer (lung, breast, ovary, endometrium, prostate, pancreas, colorectal cancer, lymphoma, leukemia and myeloma) between 01/01/2017 and 31/12/2022, with at least one year of prior history available in CPRD GOLD before cancer diagnosis. Individuals with a diagnosis of cancer (any, excluding non-melanoma skin cancer) any time prior to the diagnosis of one of the selected cancers will be excluded.OUTCOME DEFINITIONS:
Polypharmacy will be defined as the concomitant prescription of >= 5 or >= 10 medications (therapeutic groups) anytime during the year prior to cancer diagnosis.
A frailty score will be calculated based on 34 diagnoses (+ polypharmacy) included in well-known frailty indexes (e.g. the eFI) recorded anytime prior or at cancer diagnosis, and will be further categorised into levels of severity: fit, mild frailty, moderate frailty and severe frailty.STATISTICAL ANALYSES
1) The prevalence of frailty and polypharmacy will be estimated at the time of cancer diagnosis.
2) Summary patient characteristics will be provided at the time of cancer diagnosis, stratified by polypharmacy status and frailty severity
3) Mortality rates will be calculated for up to 365 days after cancer diagnosis
All analyses will be stratified by cancer type and age groupsBENEFIT FOR PATIENTS
Frailty, polypharmacy, and comorbidities are common and can have adverse impact on cancer outcomes and treatment. This study can inform future programs to improve healthcare for cancer patients with frailty and polypharmacy.
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Prescribing patterns in the context of multimorbidity: a UK population cohort study. — Aroon Hingorani ...
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Prescribing patterns in the context of multimorbidity: a UK population cohort study.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-18
Organisations:
Aroon Hingorani - Chief Investigator - University College London ( UCL )
Natalie Fitzpatrick - Corresponding Applicant - University College London ( UCL )
Alasdair Warwick - Collaborator - University College London ( UCL )
Ana Torralbo - Collaborator - University College London ( UCL )
Andrej Ivanovic - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University of Birmingham
Chris Finan - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Jorgen Engmann - Collaborator - University College London ( UCL )
Laura Pasea - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Rory Maclean - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Tina Shah - Collaborator - University College London ( UCL )Outcomes:
1. Frequency of the most commonly prescribed drugs (and drug classes) by age, sex, ethnicity and socioeconomic status
2. Frequency of the most common combinations of drugs (and drug classes) by age, sex, ethnicity and socioeconomic status
3. Strength of association between prescribed drugs (and drug classes) and diagnosed health conditions by age, sex, ethnicity and socioeconomic status
4. Frequency and strength of association between emergency department presentations and prescribed drugs (and drug classes) by age, sex, ethnicity and socioeconomic status
5. Frequency and strength of association of mortality and prescribed drugs by age, sex, ethnicity and socioeconomic statusDescription: Lay Summary
Individuals often suffer from two or more health conditions at the same time. This is commonly known as âmultimorbidityâ. Sometimes the combination of medications that people with multimorbidity are prescribed by their doctor will result in harm to the patient, for example they may experience ill effects because of the interaction of the two medications. More research is needed to understand which drugs that are commonly prescribed together so researchers can detect which combinations of drugs doctors prefer to prescribe, and understand how often drug combinations that cause harm to patients are prescribed to patients compared with combinations that do not cause harm. Understanding the patterns of prescribing, for example by age, sex, ethnicity and socioeconomic status, will help inform guidance around prescribing in multimorbidity to help clinicians make better prescribing decisions for all patients. This will benefit patients because the risk of them receiving combinations of drugs that cause them ill effects will be reduced.
Technical SummaryThe aim of this study is to characterise the relationship between accrual of diagnoses and prescribed medications through the life course to inform medicines optimisation in people with multimorbidity. We will: calculate the frequency of medications and medication classes prescribed by age, sex, ethnicity and socioeconomic status (SES); identify and quantify the frequency of medications most often prescribed together; and investigate which medications or combinations of medications are most commonly prescribed with which health conditions, and are associated with increased or reduced emergency department presentations and mortality.
Our study is a retrospective cohort study among individuals >1 year whose records meet research standards set by CPRD. Prescription frequency will be calculated by mapping the CPRD Aurum Drug Issue Table to BNF and SNOMED-CT. CPRD AURUM and IMD data will be used to stratify our analyses by SES; HES APC and OP data to provide case ascertainment and study covariates; HES A&E data to assess emergency admissions; and ONS data to assess mortality. Age- and sex-standardised prescription rates will be used to quantify patterns of co-prescription and relationships to disease or disease combinations.
We will use partial correlation or risk-ratio to quantify the strength of association between prescribed drugs and diseases. Cox-proportional hazards regression will be used to quantify associations between prescribed drug and emergency department presentations and mortality, and time-varying exposures to investigate whether patients with specific prescribing patterns have higher rates of adverse outcomes. We will use network analysis to visualise non-random associations between drug-drug pairs and drug-disease pairs.
Understanding which prescriptions are commonly associated with an increase in emergency admissions and mortality will raise awareness about inappropriately prescribed drugs that lead to severe outcomes. In addition, we will uncover whether differences in prescribing patterns explain poorer outcomes in certain subgroups to inform prescribing changes to reduce health inequities.
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Exploring the treatment pathway for patients with Alagille syndrome or progressive familial intrahepatic and investigating the association between serum bile acid levels and pruritis — Jennifer Davidson ...
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Exploring the treatment pathway for patients with Alagille syndrome or progressive familial intrahepatic and investigating the association between serum bile acid levels and pruritis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-21
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Andre Ng - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
1. Demographic and clinical characteristics of patients with the rare conditions ALGS and PFIC (objective 1)
2. Treatment pathway for ALGS: number and percentage of patients in receipt of relevant treatments using primary care prescriptions and secondary procedures, Sankey diagram (objective 2)
3. Treatment pathway for PFIC: number and percentage of patients in receipt of relevant treatments using primary care prescriptions and secondary procedures, Sankey diagram (objective 2)
4. Risk of pruritus (objective 3)
5. Liver transplant-free survival (exploratory objective 1)Description: Lay Summary
Alagille syndrome (ALGS) is a hereditary condition that affects the body in several ways. ALGS affects the liver and gut but can also cause problems to the heart disease and bones. The disease is evident within 3 months after birth and occurs in 1 in 30,000 to 70,000 births.
Progressive familial intrahepatic cholestasis (PFIC) is a group of hereditary liver disorders. PFIC is estimated to occur in 1 in 50,000 to 100,000 births. Onset usually occurs during early infancy and the condition can lead to serious liver disease.
Individuals with ALGS and PFIC experience itchy skin of varying severity, referred to as pruritus. It is difficult to treat because its cause is not well understood. One substance thought to cause the sensation of itch is bile acid, which is produced by the liver. Treatments that lower bile acid levels can reduce pruritus.
In this study, we will use anonymous routinely collected healthcare data from primary care practices and hospitals in England to describe the characteristics of patients with ALGS and PFIC, both patient populations who experience pruritus, as well as treatments they receive, and investigate the relationship between bile acid levels and the occurrence of pruritus.
Technical SummaryAlagille syndrome (ALGS) is a hereditary disorder, evident within 3 months after birth, occurring in 1 in 30,000 to 70,000 births. ALGS manifests as cholestasis, cardiac disease, ocular or skeletal abnormalities, or characteristic facial features, and can lead to end stage liver disease or death.
Progressive familial intrahepatic cholestasis (PFIC) is a group of hereditary liver disorders that cause cholestasis, estimated to occur in 1 in 50,000 to 100,000 births and increases risk of end stage liver disease.
Most individuals with ALGS and PFIC experience cholestatic pruritus (i.e., itchy skin), the underlying mechanisms of which are not well understood and possibly caused by one or more pruritogens like bile acid. Bile acid diffuses into systemic circulation and skin during cholestasis, stimulating pruritogenic neural fibers in the skin, causing itch. Serum bile acid (sBA) is the biomarker for bile acid levels used to evaluate liver function and is typically elevated in cholestatic pruritus. Treatments that can lower sBA levels, such as ursodeoxycholic acid, rifampicin, plasmapheresis and partial biliary diversion, can therefore be effective in treating cholestatic pruritus. There is a lack of real-world evidence investigating the relationship between sBA levels and pruritus.
We aim to use routinely collected primary and secondary care data from England (i.e., Clinical Practice Research Datalink, Hospital Episode Statistics, and Office for National Statistics) to describe the characteristics of patients with ALGS and PFIC, both patient populations who experience pruritus, and their treatment pathway using Sankey diagrams. We will investigate the association between sBA levels and pruritus among individuals with pruritus within 90 days of sBA reading using unconditional logistic regression, as well as explore liver transplant-free survival and pruritus using Cox proportional hazards regression. This work will increase understanding of treatment patterns among individuals with ALGS and PFIC and the relationship between sBA levels and pruritus.
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The role of inequalities in asthma care and outcomes in England: a cohort study of people with asthma — Jennifer Quint ...
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The role of inequalities in asthma care and outcomes in England: a cohort study of people with asthma
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-18
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Zakariah Gassasse - Collaborator - Imperial College LondonOutcomes:
The following outcomes will be investigated during the follow-up period:
Primary outcomes:
1) Asthma-related health service utilisation:
-Number of General Practice (GP) consultations
-Asthma exacerbations (defined as a GP or hospital admission for acute exacerbations of asthma or a GP prescription of an oral corticosteroid and respiratory-related antibiotic)
-Emergency department attendances (asthma-specific and all-cause)
-Number of hospital admissions
-Number of emergency and non-emergency hospital admissions
-Length of hospital stay
-Intensive Care Unit (ICU) admission
-Re-admission2) Asthma prescriptions:
-Maintenance medications (including inhaled corticosteroids, long acting beta agonists, long acting muscarinic antagonists and their combinations)
- Short acting asthma medications (short acting beta agonists, short acting muscarinic antagonists)
-Asthma medication ratio (AMR) (controller-to-total medications)3) Mortality:
- All-cause mortalitySecondary outcomes include unit costs for asthma-related health service utilisation events and prescriptions according to the National Health Service (NHS) References Costs and the National Cost Collection.
Description: Lay Summary
Asthma is a disease that affects the lungs. Coughing and feeling out of breath are symptoms of asthma. The United Kingdom has one of the highest number of people living with asthma in the world. There is concern that differences in social status, wealth, ethnicity, and opportunities between different groups of people may impact asthma and how it is managed. As these differences have been getting worse over the last 10 years, it is important to understand how this affects people with asthma. One area which is important to study is how an individual's position in a society, determined by wealth, occupation, and social class, can affect people with asthma. This in turn will help to create strategies to improve the health of people with asthma with different backgrounds. We will use primary care data to look for differences in how people with asthma are managed at general practices and in hospital with different positions in society in England and how much this costs the National Health Service over time. We will also study whether there are differences by age, sex, and ethnicity. This project is a part of a three nation study (England, Scotland and Wales) and we will present our results alongside those from colleagues in Scoland and Wales, which will be conducted in parallel.
Technical SummaryAsthma is a chronic respiratory condition characterised by coughing, wheezing, chest tightness and breathlessness. The UK suffers from one of the highest rates of asthma prevalence in the world, with inequalities worsening over the last decade. Meanwhile, the UK economy has borne over £1 billion annually in treating and managing asthma. Few studies have investigated the role of inequalities in asthma care and outcomes. For example, a study in Wales assessed the association between socioeconomic status and asthma, but only in Wales and before COVID-19. To that end, we aim to extend the analysis undertaken in Wales to England as part of a bigger three UK nation study to understand asthma inequalities in the UK. Using CPRD Aurum primary care data linked with hospital episode statistics (HES) APC, A&E, and ONS mortality and socioeconomic status data, we will investigate the association between Index of Multiple Deprivation and asthma care and outcomes including number of hospital admissions, A&E admissions, exacerbations, GP prescriptions and consultations, and mortality, adjusting for sex, age and ethnicity. We will fit negative binomial multilevel models to estimate the incidence rate ratio for variables that represent the count of asthma-related events within a given Index of Multiple Deprivation quintile compared to the least deprived quintile. We will fit survival models to determine factors associated with asthma-related death. We will also perform an economic analysis to estimate the direct costs of asthma inequalities from a healthcare system perspective. In addition, we will use time series techniques to investigate whether the magnitude and patterns of asthma inequities have changed over the last decade, including during the pandemic. We will present our results alongside comparable analysis of Scottish and Welsh data, which will be conducted in parallel, by project partners in each respective nation.
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Burden of disease in high-risk patients without prior myocardial infarction or stroke in the UK — Queenie Chan ...
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Burden of disease in high-risk patients without prior myocardial infarction or stroke in the UK
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-28
Organisations:
Queenie Chan - Chief Investigator - Amgen Ltd
Queenie Chan - Corresponding Applicant - Amgen Ltd
David Neasham - Collaborator - Amgen Ltd
Francesco Giorgianni - Collaborator - Amgen Ltd
Ian Wong - Collaborator - University College London ( UCL )
Isobel Piper - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Meda Sandu - Collaborator - Amgen Ltd
Michael Duxbury - Collaborator - Amgen LtdOutcomes:
Myocardial infarction following index date; Stroke following index date; Ischemia-driven arterial revascularisation following index date; Cardiovascular death; Coronary heart disease death; Death from all causes; Composite of myocardial infarction, stroke, ischemia-driven arterial revascularisation, all-cause death following index date; Composite of myocardial infarction, stroke, ischemia-driven arterial revascularisation, cardiovascular or coronary heart disease death following index date; Lipid measurements following index date; Prescribing records of lipid-lowering-therapies, including statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors, bempedoic acid
Description: Lay Summary
Heart disease is the leading cause of death and disability the UK and globally. High blood cholesterol is a significant risk factor for developing heart diseases and high LDL (âbadâ) cholesterol is associated with increased risk of stroke and heart attack. In the UK, around 7.6 million people are living with heart disease each year - with an ageing and growing population, we could see these numbers rise still further. Recent advances in medicine, there are treatments now available to substantially lower levels of bad cholesterol in patients with heart disease and preventing them to have stroke and heart attack in the future. These medical treatments also provide an opportunity to help patients to control their bad cholesterol levels and preventing them to have heart disease. The aim of the study is to look at how many patients have these risk factors for heart disease and bad cholesterol, find out more about them, their characteristics, their levels of bad cholesterol, how they are treated and how many develop heart disease. We will use the CPRD database linked to Hospital Episode Statistics Admitted Patient Care (HES APC) data to look at how many patients may develop heart disease, and the impact of this problem to patients and the healthcare system. Our findings will help the government to decide about research priorities and may inform policies to reduce this public health problem.
Technical SummaryCardiovascular disease (CVD) is the leading cause of death and disability in the UK, it has significant adverse effects on patients and puts substantial strain on our healthcare system. High levels of low-density lipoprotein cholesterol (LDL-C) are associated with increased risk of major adverse cardiovascular events (MACE). There are lipid lowering therapies (LLT) now available to substantially lower LDL-C levels in patients with CVD and reduce risk of MACE. Patients without prior cardiovascular events, having established risk factors and elevated LDL-C may also benefit from intensive LLT. The aim of the study is to estimate the prevalence of high-risk pre-cardiovascular-event population in the real world, characterize the high-risk population, and examine the incidence of MACE using the CPRD databases with HES APC data.
High-risk patients (those with coronary artery disease, cerebrovascular disease, peripheral arterial disease, diabetes mellitus with microvascular complications or chronic insulin use), elevated LDL-C and other risk factors (e.g., chronic kidney disease, cigarette smoking) will be selected for the prevalence calculation. Prevalence for each calendar year will be estimated by counting the number of high-risk patients divided by the population in CPRD database. Descriptive statistics will be used to study characteristics of patients and their LLT patterns.
HES APC data will be used to determine hospitalisations and the MACE outcomes and Office of National Statistics (ONS) Death Registration data will be used for the cause of death (cardiovascular death, coronary heart disease death). Incidence of each individual cardiovascular event, mortality event and the defined composite endpoints will be calculated by counting the number of incident cases of each event/composite across the study period divided by the population at risk.
Evidence generated from this study will provide valuable information on the burden of CVD for the National Health Service (NHS) and other policymakers on research priorities and policy initiatives.
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A study of cardiovascular disease in patients with cancer- an electronic healthcare record analysis using primary care UK data. — Evangelos Kontopantelis ...
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A study of cardiovascular disease in patients with cancer- an electronic healthcare record analysis using primary care UK data.
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-06
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Ali Alshahrani - Corresponding Applicant - University of Manchester
catharine Morgan - Collaborator - University of Manchester
Glen Martin - Collaborator - University of Manchester
Mamas Mamas - Collaborator - Keele University
Rathi Ravindrarajah - Collaborator - University of ManchesterOutcomes:
During all phases of the project, the primary outcome will be cardiovascular disease (CVD) including acute myocardial infarction, heart failure, stroke, diabetes, atrial fibrillation, valvular heart disease, and peripheral vascular disease.
All outcomes will be determined during the follow-up period by matching with the appropriate Read/SNOMED codes found in electronic health records. The identification of hospitalisation cases resulting from CVDs is accomplished by establishing a linkage to the Hospital Episode Statistics Admitted Patient Care (HES APC) database, utilising the 10th version of the International Classification of Diseases (ICD-10). The mortality data from the Office for National Statistics (ONS) will be utilised in order to determine the precise reasons of death, such as cancer-related, cardiovascular, or all-cause mortality, based on ICD-10 codes.
Description: Lay Summary
This study aims to understand how cancer and heart disease (cardiovascular disease "CVD") are related and how they can affect patients at the same time. Because survival rates after a cancer diagnosis have improved, individuals with cancer face the risk of developing CVD. Cancer and CVD share common risk factors like being overweight, smoking, or having diabetes. Additionally, certain cancer treatments may increase the chances of developing CVD in cancer patients.
The study will use data from the UK's primary care system to look at how commonly overall and specific CVDs rates have changed over time in different groups of patients in relation to different types of cancer and other factors. These obtained historical data will be used to try to predict how common CVD will be in cancer patients over the next 10 years. There are models that can tell how likely someone is to have a heart attack or stroke in future based on information, such as their age, cholesterol level, height, and weight. However, it is unclear if these models work well when applied to patients who are diagnosed with cancer. A CVD risk prediction model called "QRISK" (derived from the âQResearchâ database and "risk") will be tested to see if it can tell individuals with cancer their future cardiovascular risk.
In conclusion, this project will explore important disease patterns and predictions about CVD in cancer patients, which can help in understanding the burden of the condition on the healthcare system and improving patientsâ overall health outcomes.
Technical SummaryDue to improvements in cancer survival, cardiovascular disease (CVD) and cancer can co-exist and clinically overlap. It is believed that cancer and CVD share common risk factors such as obesity, diabetes mellitus, and smoking. At the same time, some anticancer therapies have been linked with an increased risk of cardiotoxicity in patients with cancer, which may enhance the development of CVD. The consequence of having CVD in patients with cancer can increase the risk of both mortality and morbidity. This in turn affects patients' prognosis and places a significant burden on the healthcare system by increasing hospitalization and admission rates.
We will analyse data from the UK's primary care setting linked with secondary data from Hospital Episode Statistics (HES) and caner registries to investigate temporal changes of CVDs over time and the development of various CV risk factors in relation to various cancer sites, stratified by age, sex, ethnicity, and deprivation status. Furthermore, we will estimate the 10-year projection of CVD and its risk factors in cancer patients by using time-trend analysis. Finally, the performance of the QRISK score in the cancer cohort will be tested statistically based on the given data to determine its performance in predicting future CVD in cancer patients, with the aim of developing new risk models tailored to patients diagnosed with cancer.
The main model through all these analyses will be a Cox proportional hazards regression. This model will be extended to incorporate competing risk event (i.e., dying from cancer), interactions (e.g., CVD risk with time), and effect modification according to different cancer sites. Considering all these aspects can result in a flexible parametric regression model that can predict absolute excess CVD risk over time.
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Influence of smoking status or vaping on severity of chronic obstructive pulmonary disease (COPD) at diagnosis, COPD management, and comorbidity diagnosis and management — Jennifer Quint ...
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Influence of smoking status or vaping on severity of chronic obstructive pulmonary disease (COPD) at diagnosis, COPD management, and comorbidity diagnosis and management
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-28
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Rong Ding - Corresponding Applicant - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Sarah Cook - Collaborator - Imperial College LondonOutcomes:
Objective 1
1. Sociodemographic factors of COPD patients at the time of diagnosis
2. Disease severity of COPD patients at the time of diagnosis
3. Prevalence of comorbidities in COPD patients at the time of diagnosis
Objective 2
4. COPD management (pharmacological and non-pharmacological)
5. Health service utilisation (annual review attendance, vaccination taken for flu, COVID and pneumonia)
6. Treatment outcomes (exacerbations, mortality, and lung function)
Objective 3
7. Comorbidity managementDescription: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a very common health condition that causes breathing problems. COPD is a leading cause of death worldwide, with smoking and vaping causing COPD symptoms such breathlessness for patients. COPD management is complex due to development of more than one illness at once. This is known as comorbidities. There is no cure for COPD. Reducing or stopping smoking is likely to prevent COPD symptoms from getting worse.
Stopping smoking is an essential method for relieving the symptoms of COPD. Vaping was introduced to help people stop smoking. It may be less harmful, but repeated vaping may still cause detrimental effects. The impact of this on COPD management is unknown.
Smoking and vaping can lead to bad social perceptions (stigma) in finding the cause of disease. This impacts disease management and has a negative impact on patients who smoke or vape. COPD patients with different smoking conditions may have other causes of disease and comorbidities. This may refer to current or ex-smokers.
This study will explore the difference between current smokers, ex-smokers, non-smokers, and vapers in terms of diagnosis, disease management, and comorbidities of COPD. This study will benefit the public by evaluating how smoking and vaping effects the risk of COPD and provide a better understanding towards the health effects of vaping.
Technical SummaryCOPD is a leading cause of death worldwide; the prevalence is around 174 million and it has caused 3.2 million deaths. There are about 3 million people in the UK living with COPD, which is around 4% of the population, among them only one third have been diagnosed.
Diagnosis of COPD is based on clinical symptoms and spirometry, but there is often a delay in diagnosis. The current focus of COPD treatment is on COPD prevention, stopping exacerbations, and relieving symptoms. Comorbidities are common, 97.7% of COPD patients have at least one comorbidity and the majority have at least four.
Smoking increases the risk of developing COPD. However, whether current or ex-smokers or those vaping have differing disease severity at diagnosis, are managed differently or have a different pattern of co-morbidity development is not clear.
The aim of this study is to investigate how current or former smoking or vaping impact on COPD diagnosis and management among patients in England.
We will use CPRD Aurum data linked with ONS death registration data, HES admitted patient care and patient level index of multiple deprivation. We will use descriptive statistics and compare the characteristics at the time of diagnosis in participants with different smoking conditions. We will use Cox regression models to study the time to first steroid prescription and the occurrence of comorbidity. Poisson or Negative Binomial regression models will be used to determine the number of hospital visits by a patient during the study period. This will guide further study about how the management of COPD and COPD comorbidity differs between smokers, ex-smokers, vapers and non-smokers. For example, hypertension will be selected as one of the comorbidities to focus on. We will mainly focus on the treatment for hypertension, including pharmacological treatment and non-pharmacological treatment.
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Predicting individual-level stroke risk associated with risperidone use in dementia using cardiovascular disease history — John Dennis ...
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Predicting individual-level stroke risk associated with risperidone use in dementia using cardiovascular disease history
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-03-04
Organisations:
John Dennis - Chief Investigator - University of Exeter
Byron Creese - Corresponding Applicant - University of Exeter
Christoph Mueller - Collaborator - King's College London (KCL)
Nalamotse Joshua Choma - Collaborator - University of Exeter
Nefyn Williams - Collaborator - University of Liverpool
William Henley - Collaborator - University of ExeterOutcomes:
Primary: ischaemic and haemorrhagic stroke;
Secondary: transient ischaemic attack, heart failure, myocardial infarction, hypertension, angina, hypocholesteraemia, coronary or peripheral artery disease, infections, fall, fractures and all-cause mortality.
Description: Lay Summary
One of the main symptoms of dementia is memory loss. Other symptoms include agitation/aggression. These symptoms make living with dementia much more difficult so treating them is important. One drug used in the UK is called risperidone. There is evidence that risperidone helps some people, but it has severe side effects, like stroke. Stroke is caused when clots in blood vessels cut of the supply of blood to the brain. It is likely that risperidone causes hundreds of strokes per year in people with dementia. Minimising stroke risk during risperidone treatment is important because there arenât many other treatment options for agitation/aggression in dementia. A big problem is that we do not know whether a specific person will have a stroke if they take risperidone. This is what we want to change in this project. We think we can use data about a personâs medical history to predict how likely they are to have a stroke if they take risperidone. To do this, we will analyse the anonymous GP records of thousands of people and compare two groups:
Technical Summary
1: people with dementia who have been prescribed risperidone.
2: people with dementia who have never been prescribed risperidone.
We will then look at how often strokes happen in these groups. Then we will find out if parts of peopleâs medical history make it more likely that they will have a stroke if they take risperidone. We hope this information will be used by doctors to help make prescribing risperidone safer.Research question
Can individual clinical history be used to estimate stroke risk in dementia patients prescribed risperidone?
Background
The antipsychotic risperidone is used for agitation in dementia but it several severe side effects including stroke. A notable gap in risk-benefit decision making is that doctors do not know how likely it is that risperidone will cause a stroke in a given individual. We know that risperidone effects cardiovascular disease (CVD) biological pathways, suggesting that CVD-related medical history might influence vulnerability to side effects. We will examine this link by employing individual risk prediction models that we developed in diabetes (eRAP 22-002000).
Aims and methods:
Aim:
To estimates heterogeneity in stroke risk if prescribed risperidone.
Objectives:
1) Quantify the absolute risk of stroke following risperidone prescription.
2) Estimate heterogeneity in individual excess stroke risk if prescribed risperidone.We will use CPRD primary care data (linked with Hospital Episode Statistics, Office for National Statistics Mortality data and Index of Multiple Deprivation data), to compare stroke risk in those prescribed risperidone (Risperidone Group) and those never prescribed risperidone (Comparator Group). The primary outcome will be stroke within 1 year of first prescription. Propensity score matching will be used to match up to 5 Comparator Group patients with each person in the Risperidone Group. First, we will estimate the relative risk of stroke in the Risperidone Group vs the Comparator Group. Second, we will evaluate heterogeneity in stroke risk across pre-specified subgroups defined by a history of CVD using the same approach. Finally, we will develop a prediction model to estimate excess risperidone-associated stroke risk for individual patients based on their characteristics. We will use Cox proportional hazard models, incorporating interaction terms between treatment group and individual patient-level clinical features. We hope these stroke risk estimates can inform more judicious prescribing in future.
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ID-391: Linking baseline mental health data to an electronic health care dashboard in children and young people: A feasibility study — Imperial College London...
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ID-391: Linking baseline mental health data to an electronic health care dashboard in children and young people: A feasibility study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental health.
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ID-397: NWL Bi-Borough Addressing Health Inequalities Impact Evaluation — NHS NWL...
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ID-397: NWL Bi-Borough Addressing Health Inequalities Impact Evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: NHS NWL
Description: Health inequalities.
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ID-390: Identifying risk factors associated with subsequent mental health crisis for children and young people in North West London — Imperial College Healthcare NHS Trust...
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ID-390: Identifying risk factors associated with subsequent mental health crisis for children and young people in North West London
Legal basis:Reseach
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Mental health. Commercial
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ID-396: #2035 indicator data — Westminster City Council...
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ID-396: #2035 indicator data
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Health indicators.
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ID-395: Agent-based Cardiovascular Disease (CVD) reduction model. A framework for assessing policy impact. Research by the London School of Economics in partnership with Westminster City Council’s Urban Lab — Westminster City Council...
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ID-395: Agent-based Cardiovascular Disease (CVD) reduction model. A framework for assessing policy impact. Research by the London School of Economics in partnership with Westminster City Council’s Urban Lab
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Cardiovascular disease.
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ID-398: NWL Bi-Borough Evaluation Framework — NHS NWL...
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ID-398: NWL Bi-Borough Evaluation Framework
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: NHS NWL
Description: Health inequalities.
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ID-394: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse — Optum Health Solutions UK...
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ID-394: Activity modelling and spend alignment using intelligence in the NW London Whole Systems Integrated Care (WSIC) data warehouse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Optum Health Solutions UK
Description: Spend alignment.
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ID-389: Exploring the Impact of Digital-First General Practice — Imperial College Healthcare NHS Trust...
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ID-389: Exploring the Impact of Digital-First General Practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Digital GP.
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ID-392: Measuring quality of primary care among patients with multiple long-term conditions and assessing the associations between quality, healthcare use and adverse health outcomes in Northwest London — Imperial College London...
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ID-392: Measuring quality of primary care among patients with multiple long-term conditions and assessing the associations between quality, healthcare use and adverse health outcomes in Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Long-term conditions.
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ID 399: Predictive Analytics for COPD and Emergency Admissions — Accenture...
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ID 399: Predictive Analytics for COPD and Emergency Admissions
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Accenture
Description: missing.
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ID-393: Impact of remote consultations on timeliness of cancer care — Imperial College London...
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ID-393: Impact of remote consultations on timeliness of cancer care
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-24
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Cancer.
Source
2024 - 02
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Understanding the predictors and consequences of homelessness in Northern Ireland — unknown...
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Understanding the predictors and consequences of homelessness in Northern Ireland
Where: unstated
When: 2024-2-12
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
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Exogenous sex steroid hormones and asthma phenotypes: a population-based prospective cohort study using UK-wide primary care data — Syed Ahmar Shah ...
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Exogenous sex steroid hormones and asthma phenotypes: a population-based prospective cohort study using UK-wide primary care data
Datasets:GP data, HES Accident and Emergency; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-06
Organisations:
Syed Ahmar Shah - Chief Investigator - University of Edinburgh
Syed Ahmar Shah - Corresponding Applicant - University of Edinburgh
Aziz Sheikh - Collaborator - University of Edinburgh
Fatima Almaghrabi - Collaborator - University of EdinburghOutcomes:
New-onset asthma defined as the first General Practitioner (GP)-recorded asthma-specific event (any of the 121 asthma-specific codes that have previously been validated in CPRD and found to have high positive predictive value); Asthma-related outcomes including asthma exacerbations, asthma severity, and asthma control.
Description: Lay Summary
Asthma is a condition that affects the airways in your lungs. People with asthma often experience difficulty breathing because these airways become narrow and inflamed. Asthma affects women more severely than men, and we suspect that hormones play a role. We're exploring the potential of using hormone medications, like birth control and hormone therapy (collectively called exogenous sex hormones), to prevent asthma in women and improve outcomes.
To make this a reality, we need to improve our understanding of how hormones impact asthma. Previous studies have given conflicting results, partly because of poorly designed research and treating asthma as a single disease. Asthma is more like a group of related conditions, not just one, similar to having both asthma and high blood pressure or high cholesterol. It's essential to note that not everyone with asthma has high blood pressure or high cholesterol.
Research suggests that conditions linked to high blood pressure or high cholesterol affect asthma, especially in women. To investigate this, we will use a UK-wide database with general practitioner (GP) data to explore if hormone medications, combined with treatments for high blood pressure and high cholesterol levels, can enhance asthma management. The results will help us understand which types of asthma in women are influenced by hormones and pave the way for testing these hormones as potential treatments for asthma.
Technical SummaryWe aim to improve our understanding of the role of exogenous sex hormones in the development and manifestation of asthma while accounting for phenotypic heterogeneity. We are particularly interested in metabolic syndrome-linked asthma as past research indicates heightened severity in female patients with this phenotype compared to others.
We will construct retrospective open longitudinal cohorts of people aged 16-70 years (follow-up period: January 1, 2005 â December 31, 2019) from Aurum to investigate: the association between exogenous sex hormones and late asthma onset in females with no asthma at the beginning of the follow-up and assess whether this association is dependent on various asthma phenotypes; how exogenous sex hormones affect asthma outcomes (exacerbations, severity, and control) in females with asthma and whether this is affected by asthma phenotypes; whether the association between exogenous sex hormones and asthma is impacted by therapeutic interventions to treat metabolic syndrome. Linked HES data will be used to confirm asthma-related hospitalisations where available.
We will use extended Cox regression for late-onset asthma, either Poisson or negative binomial regression based on the outcome distribution for asthma exacerbations, binary logistic regression for asthma control, and ordered logistic regression for asthma severity. All models will be adjusted for several potential confounding factors. For the identification of asthma phenotypes, we will use both a machine learning-based approach (k-means clustering) and existing recognised phenotypes a priori. To assess how consistent findings are across UK nations, we will repeat the analyses using GOLD. Linked IMD and algorithm-derived ethnicity data will be used to investigate if the associations being investigated differ by socioeconomic status and ethnicity.
The results will offer evidence to pinpoint women who can benefit from sex steroid hormone interventions and those at risk. The findings will contribute valuable insights to asthma guidelines, facilitating targeted management for women with asthma.
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The efficacy and safety of concomitant treatment with dapagliflozin and sitagliptin in patients with type II diabetes: Outcomes in real world practice. — ...
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The efficacy and safety of concomitant treatment with dapagliflozin and sitagliptin in patients with type II diabetes: Outcomes in real world practice.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-08
Organisations:
- Chief Investigator -
- Corresponding Applicant -
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Irena Orel - Collaborator - Krka - Slovenia
Nina LukaÄ - Collaborator - Krka - Slovenia
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Redenšek Trampuž - Collaborator - Krka - Slovenia
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Mean change from baseline in HbA1c at checkpoint 1, mean change from baseline in HbA1c at checkpoint 2, proportion of subjects with in HbA1c <6.5% checkpoint 1, proportion of subjects with in HbA1c <6.5% checkpoint 2, proportion of subjects with in HbA1c <7% checkpoint 1, proportion of subjects with in HbA1c <7% checkpoint 2, proportion of subjects with HbA1c reduction from baseline ⥠1% at checkpoint 1, proportion of subjects with HbA1c reduction from baseline â¥1% at checkpoint 2, rolling average of each HbA1c measurement during entire observation period, mean change from baseline in fasting plasma glucose at checkpoint 1, mean change from baseline in fasting plasma glucose at checkpoint 2, mean change from baseline in weight (kg) at checkpoint 1, mean change from baseline in weight (kg) at checkpoint 2, mean change from baseline in systolic blood pressure at checkpoint 1, mean change from baseline in systolic blood pressure at checkpoint 2, mean change from baseline in total cholesterol at checkpoint 1, mean change from baseline in total cholesterol at checkpoint 2, mean change from baseline in low density lipoprotein at checkpoint 1, mean change from baseline in low density lipoprotein at checkpoint 2, mean change from baseline in high density lipoprotein at checkpoint 1, mean change from baseline in high density lipoprotein at checkpoint 2, mean change from baseline in triglycerides at checkpoint 1, mean change from baseline in triglycerides at checkpoint 2, adverse events (presented individually, by type/site and overall): acute pancreatitis, acute renal failure, angioedema, arthralgia, arthropathy, back pain, balanitis and related genital infections, blood creatinine increased, blood urea increased, bullous pemphigoid, constipation, creatinine renal clearance decreased, cutaneous vasculitis, diabetic ketoacidosis, dizziness, dry mouth, dyslipidaemia, dysuria, exfoliative skin conditions including Stevens-Johnson syndrome, fatal and non-fatal haemorrhagic and necrotizing pancreatitis, fungal infection, haematocrit increased, headache, hypersensitivity reactions including anaphylactic responses, hypoglycaemia, impaired renal function, interstitial lung disease, myalgia, necrotising fasciitis of the perineum (Fournier's gangrene), nocturia, polyuria, pruritus, pruritus genitalia, rash, thirst, thrombocytopenia, tubulointerstitial nephritis, urinary tract infection, urticaria, volume depletion, vomiting, vulvovaginal pruritus, vulvovaginitis, weight decreased.
Description: Lay Summary
Patients with type II diabetes (T2DM) have elevated blood glucose which is associated with an increased risk of a range of conditions including heart disease, stroke, kidney disease and eye complications. Approximately 5.4% of people in the United Kingdom have T2DM. Initially, patients may try to control their glucose levels by lifestyle and dietary modifications but most patients will require medication. Various therapies exist, and some may be more appropriate than others depending on the characteristics of the individual patient. Often, glucose levels will increase after a period of time on one drug, and it may be decided that another drug should be added to the patientâs regimen. In this study we want to use the Clinical Practice Research Datalink to see what happens to HbA1c, a measure of blood glucose, when patients initially taking one of two drugs (dapagliflozin or sitagliptin), with or without metformin background therapy, have the other drug added. We will compare HbA1c and other relevant indicators at baseline (before the second drug is added) to two subsequent timepoints (90â270 days and 271â450 days). We will also see if these patients have side-effects in the 12 months after taking the two drugs together and compare them to other patients on the same initial drug who have a different drug added. By conducting such a study, we aim to show that the use of the drugs in combination is effective and safe which may improve patient outcomes and provide savings for healthcare services.
Technical SummaryType II diabetes (T2DM), affects 5.4% of the UK population and is associated with increased risk of vascular complications. Assuming an absence of contra-indications, guidelines recommend patients initiate treatment with metformin. If their glycaemic control worsens, treatment is intensified with another anti-diabetic agent as dual-therapy. Patients may then progress to triple-therapy. We propose a retrospective, single-arm study in the Clinical Practice Research Datalink GOLD and Aurum databases to evaluate the association of initiation with combination dapagliflozin/sitagliptin therapy (with or without metformin background therapy) upon T2DM biochemical markers and safety outcomes. T2DM patients prescribed dapagliflozin or sitagliptin who were first treated with the other drug will form the study cohort. Index date will be the date that dapagliflozin and sitagliptin are prescribed concomitantly. Patients prescribed other antidiabetic agents will be excluded with the exception of metformin, provided the metformin therapy is not initiated or modified 3 months prior to index date and is prescribed a daily dose â¥1500mg. A reference group whose antidiabetic therapy (dapagliflozin or sitagliptin) is augmented with a different antidiabetic agent will be matched for safety evaluation. Baseline HbA1c (measurement within 6 months and nearest to index date)âwill be compared to two subsequent timepoints post index date (90â270 days and 271â450 days) using the dependent t test or paired sample Wilcoxon signed-ranks test. The proportion of patients reaching targets (HbA1c reduction of 1%, HbA1c <6.5%, HbA1c <7%) will be reported and mean changes in fasting glucose, weight, systolic blood pressure and lipids at both checkpoints will be compared. The incidence of safety events will be reported in the year post-index and compared to the reference group by incidence rate ratios evaluated by the mid-p test. This study will provide valuable data to inform the impact of these drugs in combination on outcomes with ultimate efficiencies for health services.
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Incidence and prevalence of Endometriosis in England between 2010 and 2020 — Jennifer Quint ...
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Incidence and prevalence of Endometriosis in England between 2010 and 2020
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-13
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Georgie Massen - Corresponding Applicant - Imperial College London
Olivia Blamires - Collaborator - Imperial College LondonOutcomes:
Incidence and prevalence of endometriosis diagnosed in primary and secondary care records
Description: Lay Summary
Endometriosis is a common condition effecting the reproductive system, it is caused when the lining of the womb grows in other places. Approximately 1 in 10 people who have periods will have endometriosis. People with endometriosis suffer from chronic pelvic (lower back and stomach) pain and may have issues with fertility. This work will calculate how many people are diagnosed with endometriosis each year (2010-2020), we will use both GP and hospital records. We will try to investigate whether the average age of diagnosis has changed, whether endometriosis is diagnosed more in certain regions. We will also investigate if endometriosis is more common in certain ethnic groups as well as if endometriosis is more common in people who are over or underweight.
This work will have significant public health benefits, as we will demonstrate how many people have endometriosis which will be important to guide and inform the provision of health care services.
Technical SummaryThere has been no recent analyses of the prevalence and incidence of endometriosis, this lack of up-to-date data means that it is difficult to accurately allocate resources given the current population who suffer from endometriosis. Endometriosis is a fibrotic disease, meaning that because of chronic inflammation, fibrotic lesions may present in the uterus. Endometriosis has been included in previous analyses of fibrotic diseases which have used electronic healthcare records to try to understand whether there is an underlying fibrotic mechanism which can lead to a person suffering from multiple fibrotic conditions (fibrotic multimorbidity).
This work looks to estimate both the incidence and prevalence of endometriosis in England using data from CPRD Aurum linked with Hospital Episode Statistics (HES) and IMD data. We will describe the temporal trends in the annual calculations of incidence and prevalence of endometriosis over the past decade (2010 to 2020). More specifically, we will use HES Admitted Patient Care (APC) data and CPRD Aurum data to identify endometriosis and subsequently compare the incidence and prevalence of endometriosis diagnosed in primary care compared with the incidence and prevalence of endometriosis recorded in HES APC as well as the incidence and prevalence of the condition recorded in both CPRD Aurum and HES APC, and the incidence/ prevalence of endometriosis recorded in CPRD Aurum or HES APC. Annual endometriosis incidence and prevalence will be stratified by age, region, socioeconomic status (using IMD data), ethnicity and BMI.
This work will have significant public health benefits, as we will demonstrate how many people have endometriosis which will be important to guide and inform the provision of health care services.
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Use of treatments for bipolar disorder in pregnancy and risk of congenital anomalies and developmental disorders in offspring — Susan Jick ...
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Use of treatments for bipolar disorder in pregnancy and risk of congenital anomalies and developmental disorders in offspring
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD GOLD Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-08
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Study 1
Primary: major congenital anomalies.
Secondary: nervous system anomalies; eye ear face neck anomalies; circulatory system anomalies; respiratory system anomalies; cleft lip and palate; digestive system anomalies; genital anomalies; urinary anomalies; musculoskeletal anomalies; general anomalies.Study 2
Primary: developmental delay.
Secondary: autism spectrum disorder; speech and language delay; motor delay.Description: Lay Summary
Medications are often needed to support the mental health of people who might become pregnant. Among patients with one specific mental health condition called bipolar disorder that includes episodes of disabling depression and periods of uncontrollable energy, stopping treatment because of pregnancy may result in the worsening of symptoms, which may be harmful to the patient and their child. However, information on the effects of these treatments during pregnancy is limited. Since studies rarely include pregnant patients, further research is needed to evaluate the safety of these medications when taken during pregnancy.
Technical Summary
This study will compare the risks of multiple outcomes in the children of people with bipolar disorder who used bipolar medications during pregnancy to the outcomes in those who did not receive these medications during pregnancy. The outcomes in the children will include stillbirth, premature birth, major birth defects, and developmental delay. The results of these studies will provide information to pregnant patients and clinicians to guide decisions about use of bipolar disorder medications during pregnancy.Our objective is to study which medications to treat bipolar disorder, and what doses, pose the highest risks of major congenital anomalies and developmental delays to help clinicians and patients make decisions regarding treatment during pregnancy. This information has the potential to improve the lives of all children whose birthing parent needs treatment for bipolar disorder during pregnancy, while continuing to support the parentsâ health.
The study population will be patients in CPRD Aurum and CPRD GOLD with at least one diagnosis of bipolar disorder and at least one prescription for a medication to treat bipolar disorder (aripiprazole, asenapine, carbamazepine, haloperidol, lamotrigine, lithium, lurasodone, olanzapine, quetiapine, risperidone, topiramate, valproate products, and ziprasidone), at any time. The population will be restricted to patients with at least one eligible pregnancy defined as an estimated start of pregnancy on or after January 1, 2000, patients aged 14-45 years, and at least one year of recorded medical data to assess prescriptions and covariates of interest before pregnancy.
We propose two studies using this cohort, with the following outcomes in offspring: 1) major congenital anomalies, with a particular focus on cardiac anomalies, diagnosed in pregnancy or within the first year after birth, and 2) developmental delay, including autism spectrum disorder, speech and language delay, and motor delay, diagnosed in early childhood. HES APC will be used to provide supporting evidence for congenital anomalies, where available. For each study we will evaluate outcomes of interest in offspring, by exposure to drug class (atypical antipsychotic, mood stabilizer, other) and individual drug type received during pregnancy. We will evaluate dosage, concomitant use of multiple study drugs, and switching of drugs. We will provide descriptive statistics for the patient population including covariates of interest. Logistic regression and general linear models will be used to calculate relative risks.
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An observational study of the characteristics, epidemiology and healthcare resource utilisation of patients with type 1 diabetes pre, peri, and post diagnosis in England. — Jennifer Campbell ...
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An observational study of the characteristics, epidemiology and healthcare resource utilisation of patients with type 1 diabetes pre, peri, and post diagnosis in England.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD GOLD Ethnicity Record; CPRD GOLD Mother-Baby Link; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-14
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Zara Cuccu - Corresponding Applicant - CPRD
Charlie Nicholls - Collaborator - Sanofi Aventis UK Holdings Limited (UK)
LICHEN HAO - Collaborator - Sanofi US Services Inc (USA)
Nancy Cui - Collaborator - Sanofi Aventis Groupe (France)
Richard Hudson - Collaborator - Sanofi Aventis UK Holdings Limited (UK)
Sonia Coton - Collaborator - CPRD
Tao Haskins-Coulter - Collaborator - CPRD
XUAN Li - Collaborator - Sanofi UK
Zara Cuccu - Collaborator - CPRDOutcomes:
The following outcomes will be explored across one or more of the pre, peri and post diagnosis periods; clinical characteristics (i.e. body mass index (BMI); smoking status; history of comorbidities at baseline; Charlson Comorbidity Index (CCI) score; history of specified autoimmune disease; presentation characteristics (i.e. abdominal symptoms); diabetes complications (i.e. diabetic ketoacidosis (DKA) and diabetic nephropathy); measures of healthcare resource (i.e. primary care consultations and referrals); longer term clinical trajectory including HbA1c and time-to diabetes complications; Family history of T1DM; maternal history of T1DM; Mental health diagnoses amongst mothers of T1DM patients; and primary care recording of diabetes-related autoantibodies.
Description: Lay Summary
People with type 1 diabetes cannot make enough of the hormone insulin and need to have insulin injections throughout the day to make sure the amount of sugar in the blood is not too high. Balancing blood sugar levels can be challenging, especially during periods of illness and for younger patients. High blood sugar levels can affect organs in the body and lead to both acute and long-term complications that might require hospital admission, increase mortality and impact quality of life.
A research trial (TN-10) has shown a drug, Teplizumab, can delay the onset of type 1 diabetes in people who are over 8 years old, and at high risk of having the disease. The trial only included patients from the United States, Canada, Australia, and Germany. The planned study will describe the characteristics of patients with type 1 diabetes before, at and after diagnosis using English electronic healthcare data. The planned study will look at how similar the trial patients were to English patients with type 1 diabetes, to see whether the results of the TN-10 trial are relevant in the UK context. There will be a particular focus on whether age at diagnosis affects diabetes outcomes. The planned study hopes to understand more about type 1 diabetes patients in England to find out whether a delay to the start of type 1 diabetes could help patients to better manage their condition, and experience fewer complications over time.
Technical SummaryThis research aims to characterise type 1 diabetes mellitus (T1DM) patients in England throughout pre, peri and post diagnosis. The aim is to investigate how delaying age at diagnosis of T1DM might affect patient outcomes and health resource utilisation. To establish the potential value of the drug Teplizumab in England should it receive regulatory approval.
The study will describe the demographics, clinical characteristics, comorbidities, complications, resource utilisation, and mortality of T1DM patients. For these descriptive analyses, CPRD Aurum will be used. A matched cohort will be used to compare healthcare resource use and all-cause mortality. Linkage to Hospital Episode Statistics will capture complications and secondary healthcare resource utilisation. ONS Death Data will be used to capture mortality. Patient Rural/ Urban classification and practice-level Index of Multiple Deprivation (IMD) will also be used. The mother-baby link will help describe maternal history of T1DM, as well as, explore rates of mental health diagnoses and healthcare resource use amongst mothers of T1DM children.
The study will explore impact from age at disease onset. A multivariate logistic regression model or mixed model for repeated measures will be used to explore whether age at diagnosis has an impact on average HbA1c in the immediate 2 years following diagnosis. A generalised linear model will explore whether age at disease onset impacts healthcare resource use. Cox regression models will explore time to first diabetes complication and all-cause mortality.
For investigating the comparability of English patients to the TN-10 trial population, both the CPRD Aurum and Gold databases will be explored, to determine availability of data and feasibility.
The research will provide public health benefit by establishing whether a delay in onset of T1DM could have beneficial effects on patient outcomes, and thus inform the potential opportunity represented by a treatment that delays the disease (e.g. Teplizumab).
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The impact of the National Data Opt-out programme on representativeness of the Clinical Practice Research Datalink (CPRD) database. — Sonia Coton ...
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The impact of the National Data Opt-out programme on representativeness of the Clinical Practice Research Datalink (CPRD) database.
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-12
Organisations:
Sonia Coton - Chief Investigator - CPRD
Sonia Coton - Corresponding Applicant - CPRD
Chisomo Mutafya - Collaborator - CPRD
Justin Chan - Collaborator - CPRD
Rachael Williams - Collaborator - CPRDOutcomes:
Selected Quality Outcome Framework (QOF) indicator conditions:
- Atrial fibrillation
- Coronary heart disease
- Heart failure
- Hypertension
- Peripheral arterial disease
- Stroke and transient ischaemic attack
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Cancer
- Chronic kidney disease
- Diabetes mellitus
- Palliative care
- Dementia
- Epilepsy
- Learning disabilities
- Mental health
- Osteoporosis
- Rheumatoid arthritis
- Obesity
Selected mortality outcomes:
- Age-standardised all-cause mortality rate (by sex and region)
- Age-specific mortality rates by sex
- Age-standardised cause-specific mortality rates, by sex, for:
~ Cancer
~ Respiratory disease
~ Circulatory disease
~ Mental and behavioural disorders
~ Diseases of the nervous systemDescription: Lay Summary
CPRD data have been used extensively for research informing public health policy, clinical guidelines, and drug safety. A key strength of these data is their representativeness to the UK population. In May 2018, a National Data Opt-out Programme (NDOP) was launched, whereby patients can request that their confidential patient information not be used beyond their personal care, e.g. not used for health research. Although CPRD uses only de-identified patient data, patients choosing to 'opt-out' will not be included in the CPRD datasets. Evidence to date suggests that people choosing to opt-out are more likely to be older, female, and less socially disadvantaged; as a result, there is concern that NDOP may lead to under-representation of sections of the population in CPRD data. This could compromise the representativeness of the CPRD database, and consequently, studies using these data might be biased, and policy decisions based on these data may not fully reflect benefits/harms for all sections of society. CPRD is therefore proposing to undertake a data quality monitoring exercise to assess any potential impact of the NDOP on the representativeness of the CPRD database. The distribution of patient demographic characteristics, proportion of people with key indicator conditions (such as atrial fibrillation, asthma, and chronic kidney disease) and deaths from specific causes (including cancers, circulatory diseases, and mental/behavioural disorders) will be plotted for each monthly database over the NDOP policy roll-out period (May 2018 to July 2022) and compared to national statistics to understand the representativeness of CPRD data over time.
Technical SummaryThe National Data Opt-out Policy (NDOP) was launched in May 2018 to enable individuals to opt out of their confidential patient information being used for purposes beyond their individual care. Differential opt-out patterns by socio-demographic characteristics could introduce bias in routine healthcare data sources, like CPRD, that are used for research and healthcare planning, and could therefore impact on the generalisability of research findings that use these data.
The aim of the proposed work is to assess the representativeness of the CPRD primary care database over time. We will assess a) the CPRD patient distribution in terms of demographic characteristics (age, sex, and socioeconomic status), b) the percentage of CPRD patients across different geographies (regions, and rural/urban classification), and c) estimate the prevalence of key indicator conditions and cause-specific mortality.
The study will comprise a series of consecutive monthly cross-sectional descriptive reports. We will use data from each monthly database build, January 2018 â July 2022, with additional analyses in archived versions of the database from the preceding decade. Key outcomes will comprise Quality Outcome Framework (QOF) indicator conditions (including coronary heart disease, diabetes mellitus, and dementia), and all cause and cause-specific mortality rates (including deaths from cancer, respiratory disease, and circulatory disease). Analyses will be undertaken in the entire CPRD database population, and in age and/or sex specific groups for certain outcomes.
Descriptive analyses will explore the distribution of key sociodemographic characteristics of the CPRD database population, by rural/urban classification and region, which will be compared to national population statistics. The prevalence of selected QOF indicator conditions and cause-specific mortality rates will be calculated for CPRD population and compared to published national annual QOF outcomes/ONS death registrations.
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The epidemiological risks of non-fatal self-harm, suicide or emergency services readmission of youth following discharge from inpatient psychiatric care — Alexander Hodkinson ...
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The epidemiological risks of non-fatal self-harm, suicide or emergency services readmission of youth following discharge from inpatient psychiatric care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-21
Organisations:
Alexander Hodkinson - Chief Investigator - University of Manchester
Alexander Hodkinson - Corresponding Applicant - University of Manchester
Carolyn Chew-Graham - Collaborator - Keele University
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Maria Panagioti - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Rebecca Musgrove - Collaborator - NHS England
Roger Webb - Collaborator - University of Manchester
Shruti Garg - Collaborator - University of ManchesterOutcomes:
Primary outcomes:
Analysis 1 First occurrence of self-harm or suicide after 1 year of being discharged from IPC.
Analysis 2 First admission to emergency services for any mental illness or substance related abuse, after 1 year of being discharged from IPC.
Secondary (exploratory) outcomes: Readmissions at 1, 2, 3 and 6 months due to self-harm, suicide or emergency services due to mental illness; Mortality; primary care clinical contacts; outpatient visits.
Description: Lay Summary
There is a higher risk of self-harm or suicide admissions following discharge from inpatient psychiatric care (IPC), particularly in the first few days and weeks after discharge. Similarly, children and adolescents who admit to emergency departments following discharge from IPC often experience worse outcomes than those with emergency department visits for other reasons. However, the evidence on how children access other healthcare including general practice and the trends related to those who present to emergency services and readmit due to self-harm, suicide and other mental health purposes remains sparse. Given the ever-changing environments and influences (pervasive social media) newer data are needed to assess whether the planned support at discharge in this vulnerable group is meeting their needs.
This epidemiological analysis involves data on NHS-patient anonymised electronic records in England. Firstly, we will measure the risk of self-harm or attempt at suicide, during the year after leaving a IPC. Secondly, we will measure the risks of admitting to emergency services for any mental illness or substance abuse related purpose after 1-year of being discharging from a IPC. In both assessments children who have been discharged will be compared to children from the general population with the same sex, age, and GP practice to see whether the relative risks are different. This analysis will help to better understand the risks of self-harm and suicide in youngsters and the associated trends that demographic, health-related and social predictors can have in those who present to emergency services.
Technical SummaryAnalysis 1 is a matched cohort study aiming to estimate the absolute and relative risk of self-harm or attempts of suicide of children/adolescents (19 years or below) in the first year after discharge from a IPC in England compared with the matched general population. Cumulative incidence will be calculated for children discharged for the first time between 1st of January 2001 and 30th June 2023 and for a general population comparison cohort matched on youth age, sex and registered general practice. Hazard ratios comparing risks between the two groups will be calculated using Cox proportional hazards models at different time points within the first year. This type of analysis has been previously used by our group on a project assessing suicide and mortality outcomes in all age groups (ISAC protocol 20_038).
Analysis 2 is a matched cohort study which will assess the risks of admission to emergency services for any mental illness or substance abuse related purpose after 1 year of being discharging from a IPC. Hazard ratios comparing risks of admission to emergency service and the general population will be calculated using Cox proportional hazards or more flexible random-effects parametric survival models.
In both analyses, we will assess the association that demographic characteristics, illness and treatments and social predictors have with those who present to hospital or emergency services due to self-harm or attempted suicide.
In addition, as a sensitivity analysis we will also assess readmissions for self-harm and suicide and admission to emergency services at 1-, 2-, 3- and 6-months following discharge.
Research findings aim to inform health service planning, influencing NICE guidance and the NHS Long-Term Plan. The goal is to support expanded access to community-based mental health services, establish new services in underserved areas, and increase overall investment in children and young people's mental health.
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Ethnic variations in risk trajectories for type 2 diabetes: an observational cohort study — Rohini Mathur ...
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Ethnic variations in risk trajectories for type 2 diabetes: an observational cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation Domains; Practice Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-20
Organisations:
Rohini Mathur - Chief Investigator - Queen Mary University of London
Binur Orazumbekova - Corresponding Applicant - Queen Mary University of London
Elizabeth Remfry - Collaborator - Queen Mary University of London
Moneeza Siddiqui - Collaborator - Queen Mary University of LondonOutcomes:
Primary outcomes:
⢠Age at diagnosis of T2D across ethnicities (Age of diabetes onset)
⢠T2D risk across ethnicitiesSecondary outcomes
⢠Age-standardised incidence and prevalence of early/late-onset T2D and the median age of T2D onset across ethnicities by demographic, socio-economic and clinical risk factorsDescription: Lay Summary
The number of people living with diabetes is increasing worldwide. Most of the scientific evidence about mechanisms of diabetes development, early prevention and diagnosis was based on studies which included predominantly older and white populations. However, some ethnic minority groups, including people of South Asian and African Caribbean ethnicities, are at higher risk of developing diabetes at a younger age and within normal body weight ranges compared to people with a white ethnic background. This could lead to delayed diagnosis and diabetes-related complications, which means current evidence may not be generalisable to the diverse world population. Therefore, this study aims to describe the ethnic differences in trends of diabetes onset and understand the pathways to diabetes utilising representative multi-ethnic UK/England population from electronic health records data to elucidate the role of different risk factors (demographic, socio-economic, clinical and behavioural) and potential interactions among them. The outputs of this research will contribute a body of evidence that can inform diabetes prevention guidelines and reduce ethnic inequalities and the burden of diabetes in the UK.
Technical SummaryThis observational cohort study aims to investigate the ethnic differences in risk trajectories to T2D using the CPRD Aurum database.
The study population will be all UK-registered individuals between 2004 and 2023 in CPRD Aurum whose records are eligible for linkage to HES and IMD data. The follow-up period will start from the latest date of the individualâs registration with a general practitioner and end at the earliest of T2D diagnosis, death, de-registration, or last data collection. The primary exposure will be ethnicity. Outcomes of interest will be T2D risk and the age of its diagnosis. The covariates of interest will include patientsâ demographic, socio-economic, clinical and behavioural characteristics.
Firstly, we will describe trends in the age-standardised incidence of early-onset T2D and the median age of diabetes onset across ethnicities by demographic, socio-economic and clinical risk factors using joinpoint regression analysis to estimate annual percentage change. Secondly, we will model ethnic- and sex-stratified trajectories to T2D by estimating the direct and indirect effects of demographic, socioeconomic, clinical and behavioural risk factors to capture potential differences in the mechanism of T2D development and its age of onset utilising the mediation analysis method. Thirdly, we will test for interactions in the pathways between risk factors across ethnic groups by incorporating the conditional process analysis method in the mediation analysis.
The findings of this study can potentially benefit people of ethnic minority groups by helping to understand better the mechanisms of early onset T2D and by facilitating earlier identification of high-risk populations and targeting interventions. The research can potentially reduce the high economic burden of healthcare costs associated with managing T2D patients by decreasing its incidence and enhancing better allocation of healthcare resources.
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Using machine learning to understand inequalities in early-onset Type 2 Diabetes and co-occurring long-term conditions — Michael Barnes ...
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Using machine learning to understand inequalities in early-onset Type 2 Diabetes and co-occurring long-term conditions
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-14
Organisations:
Michael Barnes - Chief Investigator - Barts and the London Queen Mary's School of Medicine and Dentistry
Elizabeth Remfry - Corresponding Applicant - Queen Mary University of London
Miriam Samuel - Collaborator - Queen Mary University of London
Rafael Henkin - Collaborator - Queen Mary University of London
Rohini Mathur - Collaborator - Queen Mary University of London
Zainab Khalid Awan - Collaborator - Barts and the London Queen Mary's School of Medicine and DentistryOutcomes:
Primary outcome:
⢠Early-onset Type 2 DiabetesSecondary outcomes:
⢠Long-term conditionsDescription: Lay Summary
Type 2 Diabetes (T2DM) is a long-term condition that usually affects people in middle age, however recently more individuals are diagnosed before the age of 40 years. This is known as early-onset T2DM. Early-onset T2DM can cause other health problems, such as heart or eye diseases and individuals living with early-onset T2DM are also more likely to experience other long term conditions, such as depression. Some groups, like women, ethnic minority groups, individuals living in socially deprived areas and those who are overweight or obese are more at risk of early-onset T2DM.
We will use use electronic healthcare records of several million people to answer questions about early-onset T2DM. Our research will use advanced statistical and computer science techniques to analyse these records and look for patterns. We want to understand what might lead to someone getting early-onset T2DM and ethnicity, age, gender and deprivation play a role. We will work closely with a public and patient involvement and engagement (PPIE) group to ensure that our research remains relevant to those impacted by it.
We expect the impact of our research will be wide-ranging, and may help improve health and social care for early- and usual- onset T2DM. The findings may support specific recommendations for people with early-onset T2DM and more personalised medical approaches.
Technical SummaryThis study seeks to quantify known and unknown risk factors for developing early-onset T2DM. We will apply a Transformer model to patient EHRs that have been ordered sequentially. We will use demographics, diagnoses, medications, hospitalisations, procedures and observations associated with each patient. Transformer models are able to handle high dimensional data due to its transformer architecture, attention mechanism and large number of trainable parameters.
In order to tune the parameters, the model will be pre-trained using a large cohort (Dataset A) from CPRD and then fine-tuned using an enriched cohort (Dataset B) including individuals who have been diagnosed with T2DM before the age of 40 (see code list). The entire cohort includes up to 1.6 million acceptable patients who are registered to a GP practice between 01/01/2000 to 31/12/2019.
We will use feature importance to understand what factors are associated with an early-onset T2DM diagnosis and explore these factors across different groups, stratified by sex, ethnic group, age and IMD. We will measure the model (precision, F1, recall) stratified across gender, ethnicity, age and IMD, and apply fairness metrics to understand how bias may impact the model. Finally, we will conduct ablation studies to assess the importance of different data in the model.
We will also explore and report on missingness between both datasets, and conduct a sensitivity analysis to understand how the amount of data a patient contributes affects model performance. We will benchmark our model to logistic regression model as well as other deep learning models.
This research can potentially generate evidence to inform clinical guidelines and the use of personalised guidelines for those with early onset T2DM. The findings may indirectly benefit patients by providing support for the risk factors of early onset T2DM and inform our understanding of where inequalities arise along the diabetes care pathway.
Source - and 13 more projects — click to show
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Comparison of participant characteristics in decentralized clinical trials conducted at home, conventional clinical trials conducted at investigative sites, and real-world patients: a descriptive study — Helga Gardarsdottir ...
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Comparison of participant characteristics in decentralized clinical trials conducted at home, conventional clinical trials conducted at investigative sites, and real-world patients: a descriptive study
Datasets:GP data, Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-12
Organisations:
Helga Gardarsdottir - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Amos de Jong - Collaborator - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Mira Zuidgeest - Collaborator - University Medical Centre Utrecht
Yared Santa Ana Tellez - Collaborator - Utrecht UniversityOutcomes:
Primary outcomes
The proportion of participants and real world patients for categorical variables (baseline characteristics) and mean (SD) for continuous variables. We will describe the differences between the trial participants, intended users, and eligible patients for both the decentralized and the conventional clinical trial.Secondary outcomes
Baseline characteristics that were not reported in both the decentralized trial and the conventional trial (but only in one of these trials) may be explored. That is, to compare whether the respective trial was representative of the real world patients without comparing the decentralized and conventional operational trial approaches.The baseline characteristics include:
- Demographics:
Age; Biological sex/gender ; Race/ethnicity; Socioeconomic status (Townsend Index)
- Medical history:
Smoking status; Duration of diabetes; Type of diabetes/insulin use; Diabetic retinopathy; Hypertension
- Biomarkers:
Body mass index; Systolic blood pressure; Diastolic blood pressure; HbA1c; Total cholesterol; HDL cholesterol; LDL cholesterol
- Medication at randomization/index date:
Metformin; Sulphonylurea; Thiazolidinedione; other hypoglycemic agents; Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker; Beta-blockers; Calcium channel blockers; Thiazide or related diuretics; Statins; NSAIDs; Proton pump inhibitors; AspirinDescription: Lay Summary
Clinical trials are needed to develop new medicines and other medical interventions. For the results from these trials to be valid, it is important that the patients who participate in clinical trials look like patients who will be treated with the intervention in the future. However, it is known that clinical trial participants are not always representative of the patients who are treated in clinical practice. For example, certain racial/ethnic groups may be underrepresented in clinical trials. Underrepresentation can occur when the criteria to participate in a clinical trial are strict. However, other factors may also influence the representativeness. For example, the location of the trial site and the study burden (e.g., how many visits are required to participate) may also influence the willingness and ability to participate.
Technical Summary
Conducting clinical trials at participantsâ homes may affect the representativeness of clinical trials. For example, because individuals who would not participate in a trial with on-site visits could participate in a trial that is conducted from the participantâs home. In the current study, we will describe whether participants from a trial conducted at participantsâ homes look like real-world patients and describe whether this is different for participants who participated in a trial that is similar to the home trial, but was conducted on-site. CPRD data will be used to investigate whether the trial participants are representative of patients in the United Kingdom primary care.Decentralized clinical trial approaches conducted at participants' homes have the promise of improving trial representativeness by allowing the inclusion of immobile participants or participants from rural areas and lowering the burden of trial participation. Broad trial representativeness is important from a health equity perspective and improves the generalizability of study results. However, there is limited data on the potential impact of decentralized trial approaches on representativeness. Therefore, this study aims to compare characteristics of participants from a fully decentralized trial (the ASCEND trial) and a comparable â in terms of clinical research question â clinical trial run at investigative sites (the POPADAD trial) to real-world patients. In this descriptive study, characteristics from primary care patients will be obtained from CPRD GOLD. Practice and patient level deprivation data will be used to determine socioeconomic status (Townsend).People with type 1 or type 2 diabetes without vascular disease (intended users) and patients who would have been eligible to participate in respectively the POPADAD and ASCEND trial will be identified by applying (the trial) eligibility criteria to the CPRD data for the trial recruitment periods and one year before: 1 November 1996 to 31 July 2001 and 1 June 2004 to 31 July 2011 for the POPADAD and ASCEND, respectively. Outcomes of interest include demographics (e.g., age and sex), medical history (e.g., smoking and diabetes duration), biomarkers (e.g. BMI,HbA1c),and medication use (e.g., insulin) as reported in the clinical trial publications. Differences and ratios (including participation to prevalence ratios) will be calculated for these characteristics. This study will add to the (limited) literature regarding decentralized trial approaches and representativeness. Additionally, the framework that is used in this study may be used to evaluate the representativeness of other (decentralized) trials in the future.
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Assessing the utility of clinical criteria and prediction models for classification of diabetes subtypes in primary care — Beverley Shields ...
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Assessing the utility of clinical criteria and prediction models for classification of diabetes subtypes in primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-21
Organisations:
Beverley Shields - Chief Investigator - University of Exeter
Katherine Young - Corresponding Applicant - University of Exeter
Andrew Hattersley - Collaborator - University of Exeter
Andrew McGovern - Collaborator - University of Exeter
Angus Jones - Collaborator - University of Exeter
John Dennis - Collaborator - University of Exeter
Julieanne Knupp - Collaborator - University of Exeter
Nicholas John Thomas - Collaborator - University of Exeter
Pedro Cardoso - Collaborator - University of Exeter
Rhian Hopkins - Collaborator - University of Exeter
Timothy McDonald - Collaborator - University of Exeter
Trevelyan McKinley - Collaborator - University of ExeterOutcomes:
Diabetes subtype - as coded by the GP and as predicted by the different classification approaches.
We will also explore the potential impact of misclassification by comparing the outcomes in those flagged as misclassified to those not flagged as misclassified including:
- Glycaemic control (HbA1c);
- Healthcare utilisation (GP visits, hospitalisation);
- Treatment (e.g. time to requiring insulin, number of tablets);
- Development of acute and chronic diabetes related complicationsDescription: Lay Summary
Diabetes is a common condition that causes a person's blood sugar level to become too high. There are many different forms of diabetes. It is important to get the diagnosis right to ensure patients get the right treatment. The most well-known forms are Type 1 diabetes, which needs life-long treatment with insulin injections, and Type 2 diabetes, which is usually treated with diet or tablets. There are also rarer types such as Maturity Onset Diabetes of the Young (MODY; a genetic form of diabetes) and Type 3c (where the pancreas, which produces insulin, becomes damaged). There are clear treatments that work for MODY patients, but for Type 3c, there is very little guidance.
Getting the correct diagnosis can be challenging. Around 7-15% of people with diabetes may be misdiagnosed with the wrong type. For people who actually have MODY or Type 3c, around 80% are misdiagnosed with other forms of diabetes.
Approaches, such as clinical calculators (https://www.diabetesgenes.org/exeter-diabetes-app/) have been developed to help with diabetes classification, but these are mostly used by diabetes specialists. Their utility in GP practice has not been assessed.
This project aims to explore how different approaches for improving diabetes classification could work by testing them in GP records, and will complement another project working with GPs to see how these approaches could be implemented in real life. Better approaches to diagnosing diabetes subtypes will have clear benefits for patients in ensuring they get the right diagnosis, and therefore the right treatment and management for their condition.
Technical SummaryBackground: There are a number of different diabetes subtypes. Ensuring patients receive the correct diagnosis is essential to them receiving appropriate treatment and care. However, misclassification is estimated to occur in 7-15% of cases, and is an even greater problem for rarer subtypes (e.g. MODY is estimated to be misdiagnosed in ~80% of cases). In line with the 2022 NICE Recommendations for Research, we have been developing approaches that use routinely available clinical features for distinguishing between different subtypes of diabetes, including clinical criteria and prediction models. These approaches work well in research data, but, to date, we have not assessed their performance in primary care.
Aim: We will analyse CPRD to explore the utility of features and models for misclassification of diabetes in primary care, and to explore their potential impact
Study population: All patients with diabetes from 2004 to date
Exposures: Clinical features routinely recorded in primary care e.g. demographics, blood test results
Outcomes: Diabetes subtype and measures relating to diabetes care e.g. glycaemic response, treatment, healthcare utilisation
Data sources: CPRD Aurum, Hospital-episode statistics, ONS death data
Methods: Analysis will be largely descriptive exploring coding of the data to enable prediction models to be implemented and examining the potential impact of running the models e.g. proportions flagged as misclassified by different approaches and the characteristics and clinical outcomes of these individuals.
Intended benefits: This work will complement an NIHR funded project where we will work with GPs to test out how the clinical models could be implemented as automated searches of their patient records to flag patients who may be misclassified and need further investigation. Helping patients get the right diagnosis for their diabetes will ensure they get the optimal treatment and management for their condition.
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Comparing direct and indirect methods to estimate prevalence of chronic diseases using real-world data — Annika Jodicke ...
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Comparing direct and indirect methods to estimate prevalence of chronic diseases using real-world data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-26
Organisations:
Annika Jodicke - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
Prevalence (direct and indirect), incidence and disease duration of Cystic fibrosis, Haemophilia, Pulmonary arterial hypertension, Pancreatic cancer and Sickle cell disease
Description: Lay Summary
Orphan medicines are treatments for diseases that affect less than 5 in 10,000 people. To encourage its research, medicine/s regulators have created faster pathways for the approval of these treatments. To classify a disease as rare we need to know how common it is. However, the use of âindirectâ methods to calculate the number of individuals affected are under discussion.
Using pancreatic cancer, haemophilia, sickle cell disease, cystic fibrosis and pulmonary arterial hypertension as examples for rare diseases we aim to understand how many people in the UK and other European countries have been living with rare diseases in the past 10 years, how many people have been newly diagnosed, and the duration of the diseases. This will allow us to verify that indirect methods can be used to determine rare diseases, which in turn will increase the speed of the classification of orphan medicines.
Technical SummaryOBJECTIVE: To compare direct and indirect estimations of prevalence of rare, chronic diseases using routinely-collected primary care electronic health records (CPRD GOLD).
STUDY POPULATION: All individuals in CPRD GOLD during the study period 01/01/2010 to 31/12/2022 will contribute to estimate incidence and prevalence. All patients with a respective disease will be used to estimate median disease duration.
DISEASES OF INTEREST:
⢠Cystic fibrosis
⢠Haemophilia
⢠Pulmonary arterial hypertension
⢠Pancreatic cancer
⢠Sickle cell diseaseSTATISTICAL ANALYSES:
1) For each disease of interest, point prevalence at 01/01/2016 will be calculated. For each patient, the first diagnosis of a disease will be considered, and duration of disease is considered to last until the end of patients follow-up time. For point prevalence, denominator is the total number of persons in observation at this date.
2) For the calculation of the incidence rate (over the total study period), only newly diagnosed patients contribute to the numerator. Denominator is the total number of person-years at risk, i.e. observation time of a patient within the study period or until a diagnosis occurs.
3) Kaplan Meier curves are used to estimate survival probabilities, with the time axis being time since first diagnosis. Median disease duration is time where the survival probability decreases to below 50%.
4) From the incidence rate and median disease duration, "indirect" prevalence will calculated.
Analyses will be conducted stratified for children (age 01-17) and adults (age >=18)BENEFIT FOR PATIENTS:
Understanding the prevalence of diseases in the population is important to inform public health planning. This study aims to test if prevalence can be adequately estimated using information on incidence and average disease durations in real-world data. This could inform the reuse of existing estimations for public health planning and potentially reduce the number of newly needed analyses.
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A cohort study to assess drug utilisation and long-term safety of galcanezumab in UK patients in the course of routine clinical care — Susan Jick ...
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A cohort study to assess drug utilisation and long-term safety of galcanezumab in UK patients in the course of routine clinical care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-21
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Claudia Becker - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of BaselOutcomes:
Number and characteristics of galcanezumab users; incidence of serious CV events (Appendix C), serious hypersensitivity reactions (Appendix D), and malignancies (Appendix E)
Patient characteristics including age, sex, calendar year of cohort entry, available database history and - follow-up (stratified by calendar year of cohort entry) (i.e. time from index date until the last date of follow-up available in the database, the study end date, or death, whichever occurs first), reason for end of database follow-up (end of data collection, end of study period, deceased), reason for end of time at risk for the outcome serious CV event, duration of available database follow-up by reason for end of time at risk for the outcome serious CV event, medication history: Antimigraine preparations (e.g. ergotamine, triptans, CGRP antagonists), biologics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) (limited to prescribed medication only), antidepressants, botulinum toxin, CV medication (categorised, e.g. beta-blockers, ACE inhibitors), history of serious CV events (myocardial infarction (MI), transient ischaemic stroke (TIA), ischaemic stroke, ischaemic heart disease, angina pectoris (AP), percutaneous coronary intervention (PCI), coronary revascularisation), history of serious hypersensitivity reactions,
CV risk factors (smoking status, BMI, hypertension, hyperlipidaemia, Type 2 diabetes mellitus, impaired renal function, history of haemorrhagic stroke),
comorbidities (psychiatric disorders, heart failure, peripheral vascular disease), days of supply for acute migraine medication, traceable start of migraine, length of migraine disease, healthcare utilisation measures (e.g. number of drugs, hospitalisations)Serious CV events including hospitalisation for: MI, TIA, ischaemic stroke, ischaemic heart disease, unstable AP, PCI, coronary revascularisation and CV death. Serious CV events will be reported as composite and individual outcomes.
Serious hypersensitivity reactions defined as hospitalisation for anaphylaxis or allergy, hospitalisations or emergency care visits for angioedema, acute asthma or acute bronchospasm, acute upper airway obstruction, epinephrine administration and death from serious hypersensitivity reactions (i.e. death after any of these events) will additionally be assessed as part of this outcome
Malignancies including a diagnosis of any cancer, excluding non-melanoma skin cancer (NMSC). Malignancies will be reported as a composite outcome (all malignancies, excluding NMSC), and by type of the first malignancy (i.e. per primary cancer site).
Description: Lay Summary
Galcanezumab is a new drug to prevent migraine headache, a disabling condition accompanied by moderate to severe (throbbing, pounding, pulsating) head pain, nausea and/or vomiting, sensitivity to light, noise and/or smell which lasts from several hours to several days. Galcanezumab has recently been licenced in the UK, Europe and other countries. This study aims to describe and understand the use of galcanezumab in the general population, as well as in special populations of interest such as the elderly or individuals with previous heart or blood vessel disease. These special populations were excluded from the clinical trials conducted before galcanezumab came on the market. Therefore, it is important to learn more about the safety of galcanezumab in these populations.
Technical Summary
The study aims to describe the population using glacanezumab with regard to patient characteristics, as well as to assess the occurrence of serious hypersensitivity reactions (undesirable and exaggerated or inappropriate reactions by the immune system), tumour growth or serious undesirable heart and blood vessel events associated with the use of galcanezumab. For comparison reasons, the frequency of serious hypersensitivity reactions, tumour growth and serious heart and blood vessel events will also be assessed in patients using topiramate, another drug which is also used for migraine prevention.
The public will benefit from this study, because to date information about the safety of glacanezumab in patients with recent heart or blood vessel disease as well as patients aged 65 years or more (who were excluded from the clinical trial population) is scarce.Galcanezumab is a humanised monoclonal antibody indicated for migraine prophylaxis in adults with at least four migraine days per month.
This is a Post-Authorization Safety Study, the primary objective of which is to evaluate galcanezumab use in all exposed patients â¥18 years and in special populations (i.e., patients with recent acute cardiovascular (CV) events and/or serious CV risk, as well as patients > 65 years). The secondary objective is to assess the incidence of serious hypersensitivity reactions, malignancy and serious CV events in users of galcanezumab, and to compare the incidence of serious hypersensitivity reactions, malignancy and CV events between users of galcanezumab and users of the comparator drug topiramate.
This will be a cohort study starting at the galcanezumab approval date in the EU/UK (14 Nov 2018) and end on 31 December 2025.It will comprise all patients with a recorded prescription for galcanezumab in CPRD Aurum, and a comparator cohort of exact, and separately, propensity score matched topiramate users. Cohort entry will be the date of their first recorded prescription for galcanezumab or topiramate in the comparator cohort. Baseline and treatment characteristics of the galcanezumab users will be described.
We will estimate crude incidence rates for each outcome of interest (using Hospital Episode Statistics admission data to determine the outcomes serious CV events and serious hypersensitivity reactions) and we will calculate hazard ratios (and 95% CIs) for serious CV events and malignancy outcomes using Cox proportional hazards regression comparing galcanezumab users to topiramate users. Several sensitivity analyses will be conducted to evaluate the robustness of the findings.
The results of the study will benefit patients and doctors with migraine by adding knowledge about the safety of galcanezumab and its potential adverse effects compared with a standard antimigraine drug (i.e. topiramate).
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Glucagon-like peptide-1 receptor agonists and the risk of suicide, suicidal ideation, and self-harm among patients with type 2 diabetes — Samy Suissa ...
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Glucagon-like peptide-1 receptor agonists and the risk of suicide, suicidal ideation, and self-harm among patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-13
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Samantha Shapiro - Collaborator - McGill University
Soham Rej - Collaborator - McGill UniversityOutcomes:
The primary outcome will be a composite of the first occurrence of completed suicide, suicidal ideation, or self-harm resulting in hospitalization during the follow-up period. The secondary outcomes will be suicide, suicidal ideation, or self-harm assessed as standalone endpoints. Suicide and self-harm will be defined by ICD-10 codes; suicidal ideation will be defined by Read and SNOMED-CT codes.
Description: Lay Summary
Type 2 diabetes is a disease where the body cannot properly regulate blood sugar levels. People with diabetes are at higher risk for many diseases, including depression. Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are a type of medication used to treat type 2 diabetes. GLP-1 RAs may potentially increase the risk of suicide and self-harm, but few studies have been conducted on this association. To address this question, we will use the Clinical Practice Research Datalink to conduct a large cohort study to determine whether the use of GLP-1 RAs is associated with an increased risk of suicide, suicidal ideation, or self-harm. The findings of this study could have important implications for prescribing practices for patients with type 2 diabetes.
Technical SummaryGlucagon-like peptide 1 receptor agonists (GLP-1 RAs) are a second- to third-line treatment for type 2 diabetes that exerts its effects through GLP-1 signalling. Several case reports indicate that GLP-1 RAs may increase the risk of suicide and self-harm, which has prompted investigation by several regulatory agencies. Observational studies on the topic are scarce and have been subject to several limitations, and stronger evidence on the association is needed.
Our study will explore the relationship between the use of GLP-1 RAs and the risk of self-harm, suicidal ideation, and suicide. We will assemble a cohort of patients aged 18 and older who were newly prescribed a GLP-1 RAs or a dipeptidyl peptidase-4 (DPP-4) inhibitor between January 2007 and March 2021. We will use Cox proportional hazards models with propensity score fine stratification weighting to estimate hazard ratios and 95% confidence intervals for the incidence of a composite of suicide, suicidal ideation, and self-harm among GLP-1 RA users compared to DPP-4 inhibitor users. The outcomes of interest will be identified using data from the CPRD GOLD and Aurum, Hospital Episode Statistics, and Office for National Statistics databases. We will conduct analyses to assess the outcomes separately and to examine whether there is a duration-response relationship, and whether the relationship varies by drug, age, sex, history of depression, history of self-harm, body mass index, or socioeconomic status. The findings of this study could have relevant implications for prescribing practices for patients with type 2 diabetes.
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Predicting remission of type 2 diabetes following bariatric surgery: external validation of existing models and model update within England primary care electronic health records — PUSHPA SINGH ...
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Predicting remission of type 2 diabetes following bariatric surgery: external validation of existing models and model update within England primary care electronic health records
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-27
Organisations:
PUSHPA SINGH - Chief Investigator - University of Birmingham
Nicola Adderley - Corresponding Applicant - University of Birmingham
Jonathan Hazlehurst - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Kym Snell - Collaborator - University of Birmingham
Shamil Haroon - Collaborator - University of Birmingham
Srikanth Bellary - Collaborator - Aston University, BirminghamOutcomes:
Model performance â We will examine the performance of existing models in UK population. Performance will be based on measures of discrimination (time-dependent C-statistic), and calibration (calibration-in-the-large, calibration slope, and calibration curves), as well as clinical utility (decision curves).
Diabetes remission will be defined as HbA1c ⤠6.5%, off glucose-lowering medications in the last 3 monthsWe will predict short-term and long-term diabetes remission. Short-term diabetes remission will be defined as remission within 12 months and long-term diabetes remission will be defined as remission within 36 and 60 months. We will include HbA1c measures within 3 months of each endpoint (12, 36, and 60 months).
Description: Lay Summary
Obesity is common and has been associated with type 2 diabetes (chronic progressive disease secondary to insulin insufficiency). Weight loss surgery can help people live longer, healthier lives and can sometimes reverse type 2 diabetes.
Lots of people could benefit from weight loss surgery but very few people are offered this surgery. But it is not widely accessible and there exist disparities between patients.
Many people with type 2 diabetes and their doctors do not think of weight loss surgery as a treatment option.
It is important to identify patients who will benefit the most following surgery to help all patients and doctors to discuss bariatric surgery and make informed decisions. Embedding prediction model in primary care will standardize the practice and may help with existing disparities.
Current models to predict type 2 diabetes reversal were developed in different countries with less ethnic diversity compared to the UK population and using information that is not normally collected by general practitioners (GPs); this means they may not be fair or work very well for UK patients.First, we will see how well some of these existing models work in the UK population, particularly in different ethnic groups and socio-economic group patients. We may need to update the model to make sure it performs fairly in different groups. We will also work with patients and other interested people to create helpful information for patients and doctors to help decide whether weight loss surgery is right for them.
Technical SummaryAims and objectives:
1. Externally validate existing models to predict type 2 diabetes remission at short (1 year) and midterm follow-up at 3 and 5 years within Clinical Practice Research Datalink (CPRD) Aurum.
2. If any of the existing models perform well overall, the predictive performance will be evaluated in subgroups based on ethnicity and socio-economic status.
3. Update the best-performing model by recalibrating and potentially including additional variables available within primary care, to improve performance in different ethnic and socioeconomic (Index of Multiple Deprivation (IMD)) groupsData sources: We will use CPRD Aurum, pseudo-anonymized electronic primary- care healthcare records to undertake external validation of available prediction models. Linkage to Hospital episode statistics (HES) admitted patient care (APC) will be required to further ensure the accuracy of bariatric surgery coding. We will use CPRD Gold for external validation of the updated prediction model.
Study population: Adults with type 2 diabetes and obesity who underwent bariatric surgery during the study period January 2010 - December 2021 will be included.
Outcome: Diabetes remission is defined as glycosylated hemoglobin (HbA1c) ⤠6.5% and off glucose-lowering medications in the last 3 months.Study design and methods
Based on predictors used, population used for developing the model, and performance, we identified four existing models- DiaRem, Ad-Diarem, DiaBetter and DiaRem2 models for validation.
Variables included in these prediction models are age, HbA1c, diabetes duration, diabetes medications, and insulin use.Performance of prediction models will be assessed by discrimination (time-dependent C-statistics), calibration (time-to-event model and calibration curves created using pseudo values for observed outcomes).
Net benefit will be evaluated using decision curves.
Identification of a model with good performance will empower primary-care physicians to have informed consultation with patients seeking help for weight management. It will improve patient understanding of treatment options and access to bariatric surgery.
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Effectiveness of COVID-19 vaccines on severe COVID-19 and post-acute cardiovascular events and diabetes following SARS-CoV-2 infection: A cohort study — Martà Català Sabaté ...
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Effectiveness of COVID-19 vaccines on severe COVID-19 and post-acute cardiovascular events and diabetes following SARS-CoV-2 infection: A cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-06
Organisations:
Martà Català Sabaté - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of OxfordOutcomes:
Vaccine effectiveness to prevent (1) COVID-19 related hospitalisation; (2) COVID-19 related death; (3) all-cause mortality in the 3 months after discharge from a COVID-19 hospitalisation; (4) all-cause mortality in the 6 months after discharge from a COVID-19 hospitalisation; (5) new-onset type 1 Diabetes Mellitus after SARS-CoV-2 infection, (6) new-onset type 2 Diabetes Mellitus after SARS-CoV-2 infection; (7) cardiovascular events (cerebrovascular disorders, dysrhythmias, ischemic and non-ischemic heart disease, pericarditis, myocarditis, heart failure and thromboembolic disease) after a SARS-CoV-2 infection
Description: Lay Summary
With high rates of COVID-19 in the community, many people receive additional COVID-19 vaccine âboosterâ doses. Some vaccines used for these additional doses have been adapted to particularly work well against new COVID-19 variants, such as omicron. However, we need to better understand how well additional vaccine doses prevent people from severe COVID-19 requiring hospitalisation or leading to death. Likewise, more data is needed on how long the protection against severe COVID-19 lasts.
Technical Summary
In addition, long-term complications after COVID-19, including persisting symptoms, but also blood clots, heart problems or diabetes have been reported. Additional research is needed to better understand if and to what extend COVID-19 vaccines can reduce the risk for those complications after COVID-19.
We will use anonymous GP records from the NHS to select groups of people with one, two, three of four COVID-19 vaccine doses. We will then match people with e.g. 3 vaccine doses to people with 4 vaccine doses, and use advances statistical techniques to make sure people win both groups are similar in terms of their age, sex, previous covid-19 and other health conditions. We then compare how many of them had severe COVID-19 or new diabetes or problems of the heart or circulation after they had COVID-19.
This study will provide insight on the benefit of (additional) COVID-19 vaccine doses. Our findings will inform strategies for future vaccination program.BACKGROUND
The Vaccine Monitoring Platform jointly coordinated by European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control includes the continuous assessment of COVID-19 vaccine effectiveness, as up-to-date real-world evidence is needed to guide regulatory and vaccination policies.OBJECTIVES
This study was requested to generate additional evidence on (1) the effectiveness of COVID-19 vaccine booster doses to prevent severe COVID-19, and (2) COVID-19 vaccine effectiveness to prevent post-acute outcomes of SARS-CoV-2 infection.METHODS
We will conduct population-level cohort studies including all people aged >=12 years, with at least 365 days of data availability before index date (ID) [ID = date of last vaccine dose] AND data availability from 12/2020 onwards (vaccination campaign start) in CPRD GOLD/AURUM with HES linkage.WP1: Effectiveness of COVID-19 booster doses:
People with a 3rd-vaccine dose of Pfizer or Moderna vaccines will be included from the source population. Among those, sequential matching will be used to match people with/without a 4th vaccine dose using Propensity Scores. We will then estimate vaccine effectiveness (1- Hazard Ratio (HR)) to prevent severe COVID-19 using Cox proportions hazard models. Negative control outcomes will be used to measure potential residual confounding. HR will be calculated for subsequent time windows after index date to evaluate waning of vaccine effectiveness.WP2: Post-acute COVID-19 complications:
Vaccine effectiveness to prevent (1) death in the 3/6 months after discharge from a COVID-19 hospitalisation, (2) new onset diabetes within 30-365days after SARS-CoV-2 infection and (3) new onset cardiovascular complications within 30-365days after SARS-CoV-2 infection. We will conduct the following comparisons using the same methodological approach as in WP1: 1st dose vs. 2nd dose vaccinated, 2nd vs. 3rd dose vaccinated, 3rd dose vs. 4th dose vaccinated.Providing insight to the effectiveness of COVID-19 boosters, this study can support public health decisions for the vaccination campaign.
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Prescribing of Opioids in Menopausal and Postmenopausal Women in the UK: A Population-based Drug Utilization Study — Ruth Brauer ...
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Prescribing of Opioids in Menopausal and Postmenopausal Women in the UK: A Population-based Drug Utilization Study
Datasets:GP data, CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-08
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Emma Tillyer - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
All calculations are in relation to the prescription for opioids, alone or in combination with HRT: Incidence; Prevalence; Discontinuation Rates (Kaplan Meier Curves)
Description: Lay Summary
The typical age when women in the United Kingdom (UK) lose their period is around 50 years, and symptoms associated with the end of this phase can persist for 10-20 years or more. A recent study was conducted on female veterans aged 45 to 64 in the United States (US) to understand how many of these women experience chronic pain. Approximately half (52%) reported chronic pain that significantly impacted their quality of life, with only some (22%) being formally diagnosed with an underlying chronic pain condition. Research indicates that hormonal changes during this life stage can lead to severe chronic pain, affecting daily functioning. In the UK, strategies for managing chronic noncancer pain involve the use of pain medications, both over-the-counter and prescription strength, along with non-medical remedies. The recommended intervention for general symptoms associated with the conclusion of a woman's reproductive phase, including moderate pain, is hormone replacement therapy (HRT). Many women over the age of 50 use HRT; however, it is not commonly prescribed for severe pain. In instances of intense and ongoing pain, opioids are frequently prescribed despite concerns about their long-term usage. This study seeks to describe patterns of opioid prescriptions, whether used alone or in addition to HRT, among women aged 50 to 79 who have ended their reproductive phase. Examining opioid prescription patterns will contribute to a better understanding of the management of chronic noncancer pain in women who no longer have their period across the UK, informing future risk-benefit studies and healthcare planning.
Technical SummaryWe aim to describe how opioids are prescribed by physicians to women of menopausal and postmenopausal age with chronic noncancer pain throughout the United Kingdom (UK). The proposed study is a descriptive drug utilisation study, which will calculate the incidence, prevalence, and discontinuation rates of opioids, alone or in combination with HRT, using 13 years (2010 to 2023) of UK primary healthcare records (CPRD Gold and Aurum). The menopausal/postmenopausal population group will be defined by age and diagnosis for a chronic noncancer pain indication. The age range used to capture menopause and post-menopause will be defined as 50 to 79 years. A diagnosis for osteoarthritis, osteoporosis, rheumatoid arthritis, polymyalgia rheumatica, fibromyalgia, sarcopenia, and chronic low back pain/back pain will define chronic noncancer pain indications. The incidence rate (IR) of women who received their first prescription for an opioid will be calculated annually using person-years at risk (PYAR) as the denominator and 95% Confidence Intervals (CI). Relative changes in annual IR will be expressed as percentages and the average percentage change will be assessed using linear regression. Annual prescribing prevalence per 100 women will be calculated using mid-year population estimates of women aged 50-79 years with chronic noncancer pain. Kaplan Meier curves will be used to calculate the discontinuation rates for opioid use, with the end event being the date of the last prescription for the opioid medication. The discontinuation rate will show the average duration of opioid use for chronic noncancer pain management in the defined menopausal/postmenopausal population group. The calculations for incidence, prevalence, and discontinuation rates will be stratified by pain indication, ethnicity, and age group. All analyses will be descriptive and will provide information regarding the prescribing rates of opioids in the menopausal/postmenopausal population group with a chronic noncancer pain indication that can be used for future studies.
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Association between herpes zoster vaccination and autoimmune rheumatic diseases in UK: A regression discontinuity analysis — James Galloway ...
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Association between herpes zoster vaccination and autoimmune rheumatic diseases in UK: A regression discontinuity analysis
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-19
Organisations:
James Galloway - Chief Investigator - King's College London (KCL)
Zijing Yang - Corresponding Applicant - King's College London (KCL)
Katie Bechman - Collaborator - King's College London (KCL)
Mark Russell - Collaborator - King's College London (KCL)
Sam Norton - Collaborator - King's College London (KCL)
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
A composite measure of the incidence of any of the following autoimmune rheumatic diseases during the study follow-up period:
Rheumatoid arthritis, Psoriatic arthritis, Undifferentiated inflammatory arthritis, Ankylosing spondylitis, Axial spondyloarthropathy, Polymyalgia rheumatica, Giant cell arteritis, large vessel vasculitis, ANCA vasculitis, Small vessel vasculitis, Systemic Lupus Erythematosus, Sjogren syndrome.The individual incidence of the aforementioned autoimmune rheumatic diseases during the study time period.
Description: Lay Summary
Autoimmune rheumatic diseases (ARD) are serious conditions that cause pain and disability. More and more people are struggling with these diseases over the past decades, posing great medical and socioeconomic burdens. These diseases have become more common and pose big challenges for affected people. There's a thought that certain viruses, like the one causing shingles, might be linked to these diseases. In the UK, folks between 70 and 79 have been advised to get a shingles vaccine since 2013.
This study wants to see if getting the shingles vaccine changes the chances of getting these diseases.
We will investigate the difference in the incidence among people vaccinated against herpes zoster compared with unvaccinated people. We will identify differences in outcomes across populations.
By conducting this research, we hope to better understand if the shingles vaccine affects these diseases. The findings will be valuable for shaping public health policies, guiding vaccination strategies, and planning future interventions.
Technical SummaryTo date, no population-level studies have investigated the impact of herpes zoster vaccination on autoimmune rheumatic diseases. The study will seek to explore the causal effect of herpes zoster vaccination on the occurrence of autoimmune rheumatic disease.
Specifically, we aim to
1) investigate if causality exists between zoster vaccination and the risk of developing autoimmune rheumatic diseases
2) assess which autoimmune rheumatic diseases have the strongest association with zoster vaccination
3) identify any variations in the above outcomes across different population groupsThe planned study design is a longitudinal retrospective observational cohort study, conducted from 1st Sep 2013 to 31st Aug 2019. To provide causal as opposed to merely correlational evidence on this question, this study will use a regression discontinuity (RD) design which is a quasi-experimental method to establish causality and assigns to groups according to a cutoff value for a continuous variable, taking advantage of the fact that eligibility for the herpes zoster vaccine was determined based on the age of individuals. We will identify the eligibility of participants based on their year of birth, which is collected in CPRD. The main analysis will estimate the effect of being eligible for the zoster vaccine and the secondary analysis will estimate the effect of receiving the zoster vaccine on composite and individual incidence of ARD. Both sharp and fuzzy RD models will be used in local linear regression with mean squared error (MSE) optimal bandwidth. The sensitivity analysis will apply different bandwidth sizes, use polynomials of varying degrees, and adjust for covariates.
The findings of this study will provide evidence of a more effective and cost-effective intervention, the zoster vaccine, for preventing ARD and are helpful for health policy making.
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Incidence, healthcare resource utilisation and mortality of invasive fungal infections (IFI) in hospitalised paediatric patients with and without ever having had an IFI-related hospitalisation in England — Gillian Kiely ...
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Incidence, healthcare resource utilisation and mortality of invasive fungal infections (IFI) in hospitalised paediatric patients with and without ever having had an IFI-related hospitalisation in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-06
Organisations:
Gillian Kiely - Chief Investigator - Pfizer Ltd - UK
Zohaib Akhter - Corresponding Applicant - Adelphi Real World
Adilia Warris - Collaborator - University of Exeter
Catherine Castillo - Collaborator - Adelphi Real World
Iman Amanour - Collaborator - Adelphi Real World
Kiran Rai - Collaborator - Adelphi Real World
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Zeshan Riaz - Collaborator - Pfizer Ltd - UKOutcomes:
IFI incidence; sociodemographic and clinical characteristics; secondary HCRU; direct healthcare costs; mortality and the long-term impact of IFIs (incidence, HCRU and associated costs).
Description: Lay Summary
Invasive fungal infections (IFIs) are systemic infections occurring due to the establishment of yeasts or moulds within deep tissues. IFIs affect over 150 million people worldwide, and result in 1.5 million deaths annually. In children, depending upon age, severity of infection, and its management, IFIs may lead to hospitalisation and death. IFIs may also have a long-term impact in children, leading to poorer lung health and brain function.
Children with IFIs may present with different symptoms than adults, particularly children who are born premature, admitted to intensive care units (ICU) or those with traumatic injuries. Further, in recent years there has been an increase in the risk of developing an IFI among children, especially in those who have a weakened ability to fight infections (i.e., poorer immune system), for example, those undergoing cancer treatment or organ transplant. However, research in this area is limited, with the majority conducted in patients with a specific type of fungal infection known as invasive candidiasis; further little is known about the burden of IFIs on the NHS in England, and which groups may be more affected.
This study aims to describe the characteristics of children with IFI-related hospitalisations and the number of deaths during hospitalisation in patients with and without ever having had an IFI. We will also explore long term impact of IFIs, and related burden on the NHS in England due to IFIs.
Technical SummaryAim: This study aims to use UK primary care data, with linkage to secondary care data to estimate the incidence, economic and disease burden of invasive fungal infection (IFI) related hospitalisations among the paediatric population in England, during indexing period of 1st January 2008 to 31st March 2021.
Objectives: To: 1) estimate the incidence of IFI (i.e., hospitalisations with a primary or secondary IFI diagnosis among all hospitalised paediatric patients aged <18 years) in England, 2) describe the baseline sociodemographic and clinical characteristics of hospitalised paediatric patients with and without ever having an IFI related hospitalisation, 3) describe healthcare resource use (HCRU) and direct healthcare costs among paediatric patients with and without ever having had IFI-related hospitalisation, 4) quantify mortality and estimate the adjusted risk of mortality among paediatric patients with and without ever having had an IFI-related hospitalisation, 5) assess the feasibility of identifying long-term effects of IFIs, the incidence and HCRU and associated costs.
Methods: A retrospective cohort study using CRPD Aurum (primary care), with linkage to HES (secondary care) and ONS datasetsExposures: IFI-related hospitalisation and age.
Stratifications: Age group; sex; GP practice geographic region; time period of hospitalisation (i.e, prior to / during / post COVID-19 pandemic); length of stay (LoS) in hospital; specific diagnoses associated with immunosuppression; socioeconomic status; and prolonged steroid use.
Outcomes: IFI incidence; sociodemographic and clinical characteristics; healthcare resource utilisation and direct medical costs; mortality; and the long-term impact of IFIs.
Data Analysis: For descriptive analysis, counts, means, medians, standard deviation (SD), 25th and 75th percentile values will be reported for continuous variables, whilst relative frequencies and proportions/percentages for categorical variables. Rates will be calculated by dividing frequency of events by person time at-risk. Poisson/negative binomial regression methods will be explored to develop mortality models whilst adjusting for known mortality risk factors.
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Comparison of cardiovascular outcomes in patients with long term exposure to Evolocumab in trial and open label extension study with an external control arm using real world data — Swati Sakhuja ...
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Comparison of cardiovascular outcomes in patients with long term exposure to Evolocumab in trial and open label extension study with an external control arm using real world data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-02-20
Organisations:
Swati Sakhuja - Chief Investigator - Amgen Inc
David Neasham - Corresponding Applicant - Amgen Ltd
Emileigh Willems - Collaborator - Amgen Inc
Francesco Giorgianni - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Matthew McDermott - Collaborator - Amgen LtdOutcomes:
Myocardial infarction;
Stroke;
Hospitalization for unstable angina;
Coronary revascularization;
Cardiovascular death;
All-cause death;
3-point major adverse cardiovascular events (MACE): Composite of Cardiovascular death, myocardial infarction, stroke;
5-point MACE: Composite of Cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization.Description: Lay Summary
Increased levels of low-density lipoprotein cholesterol (LDL-C) (so-called "bad cholesterol") in the blood increase the risk of heart disease which is one of the leading causes of ill health and death worldwide.
Technical Summary
In a previous clinical trial, evolocumab has been shown to lower âbad cholesterolâ levels and reduce the risk of future heart disease compared to placebo or standard of care treatment.
A follow-up study, conducted as an open-label extension (OLE) of the original clinical trial, showed that long-term use of evolocumab is safe but unlike the original trial, it did not compare heart disease related events with a placebo or standard of care treatment arm (since all participants in the OLE were on evolocumab). Therefore, the aim of the current study is to compare heart disease outcomes in patients who take evolocumab versus patients on standard of care over a long duration of time.
Firstly, we will check to see if it is possible to use the Clinical Practice Research Datalink (CPRD) to create a real-world standard of care (SOC) treatment arm and compare this SOC arm to data from the clinical trial/OLE. If the latter is possible, we will then compare the heart disease outcomes in the CPRD standard of care arm to the heart disease outcomes in the evolocumab arm of the clinical trial and OLE. The expected health benefit of our study would be the possibility to evaluate the long term effectiveness of evolocumab using a combination of clinical trial data and real world data.Further cardiovascular OUtcomes Research with proprotein convertase subtilisin/kexin type 9 (PCSK9) Inhibition in participants with Elevated Risk (FOURIER) trial for Evolocumab, a PCSK9 inhibitor (monoclonal antibody) demonstrated that it can effectively lower low-density lipoprotein cholesterol (LDL-C) levels by almost 60% and also reduce the occurrence of major adverse cardiovascular (CV) events among statin-users at high risk for CV disease. The long-term follow-up open-label extension (OLE) studies following FOURIER trial completion demonstrated that long-term use of Evolocumab is safe. However, since all patients enrolled in the OLE study were on Evolocumab, there was no long-term standard of care control arm within the FOURIER-OLE study to compare against. Therefore, the aim of the current study is to compare risk of CV outcomes in FOURIER and FOURIER-OLE patients in the Evolocumab arm versus an external control arm created using CPRD Aurum database linked with Hospital Episode Statistics Admitted Patient Care (HES-APC) and Office of National Statistics (ONS) mortality data. A gated framework will be used that will include assessing balance of propensity scores and comparability of key variables at baseline as compared to trial/OLE Evolocumab participants. Additionally, the comparability of outcome events using hazard ratio estimates for the weighted real-world external control arm and the trial placebo arm during the original trial period will also be assessed.
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ID-387: Hyperextension — Imperial College Healthcare NHS Trust...
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ID-387: Hyperextension
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Hyperextension.
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ID-386: Evaluation of Harrow Winter Wellness 23/24 — Harrow Council...
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ID-386: Evaluation of Harrow Winter Wellness 23/24
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-24
Opt Outs: no information provided./p>
Organisations: Harrow Council
Description: Winter wellness.
Source
2024 - 01
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ADR Wales themed projects: Social Care — unknown...
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ADR Wales themed projects: Social Care
Where: unstated
When: 2024-1-15
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The ADR Wales Social Care programme is led by Social Care Wales, a Welsh Government-sponsored body which registers and sets standards for social workers and social care workers in Wales. This programme will promote the benefits of linked data research and demonstrate its potential for understanding social care in Wales and beyond.
The team will support social care stakeholders, including local authorities, third sector organisations and care providers in the independent sector, to identify and refine their own research priorities. They will also lead a national research priority setting exercise on linked data research in adult social care.
The team will engage with data owners and data collectors, such as local authorities and care providers in the independent sector, with a focus on acquiring de-identified adult social care data for research. The team will continue to support the development of the adult social care census to ensure that it can be made securely available for linked data analysis after it has been collected.â¯
Although adult social care will be the main focus of this work programme, the team will continue to facilitate the supply of updated childrenâs social care data and promote linked data research in social care.
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What is the rate of occurrence of brief interventions in face to face versus remote consultations for adults in English primary care? An open cohort study of routinely collected healthcare data. — Paul Aveyard ...
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What is the rate of occurrence of brief interventions in face to face versus remote consultations for adults in English primary care? An open cohort study of routinely collected healthcare data.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-15
Organisations:
Paul Aveyard - Chief Investigator - University of Oxford
Laura Heath - Corresponding Applicant - University of Oxford
Brian Nicholson - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Joseph Wherton - Collaborator - University of Oxford
Katja Maurer - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Susannah Fleming - Collaborator - University of OxfordOutcomes:
Objective 1: The number and proportion of consultations of different modes conducted every month during 2019 and the most recent year for which there is complete data available. These will be compared to EMIS consultation mode codes (consmedcodeid and consourceid) and percentage agreement between the systems calculated. Lists of the most frequent discrepancies will be reviewed and narratively analysed.
Objective 2: Outcomes of interest include the offer of advice, or referral for further support for the four main behavioural risk factors.
1. Smoking â a. smoking cessation advice given; b. referral to smoking cessation services.
2. Obesity â a. weight management advice given; b. referral to further weight management support.
3. Problem drinking â a. advice about alcohol intake; b. referral to alcohol support service.
4. Physical inactivity â a. advice about physical activity; b. referral to exercise on prescription or similar service.Description: Lay Summary
Smoking, obesity, alcohol intake, and physical inactivity bring forward the onset of chronic disease and premature death by about 6 years in the UK. One way the NHS addresses this is through preventive healthcare. This includes supporting people to change their behaviour. This support has been shown to be effective and cost-saving. However, the rate of intervention by healthcare professionals is low. The shift to remote (usually telephone) consulting may have reduced opportunities for this. Initial research shows that telephone consultations are more transactional, with less discussion of âotherâ health topics, including preventive care.
This study will firstly develop a system to categorise whether consultations occurred remotely or face to face within the CPRD database. Secondly, we will assess the rate of preventive care using anonymised general practice records. We will explore whether the type of consultation (face-to-face, telephone, video or email) affects preventive care delivery in UK primary care. This will be analysed for the whole adult population, and then by subgroups, including people from different age groups, ethnic groups or sex. This will help healthcare professionals and policy makers understand where prevention is working well and where it can be improved for the whole population.
Technical SummaryAim: To quantify the rate of occurrence of brief interventions (BI) for smoking, obesity, excess alcohol, and physical activity by consultation mode in English primary care. Understanding if BIs are being delivered across all consultation modes is the first step to optimise implementation.
Objective 1: To develop a consultation categorisation system in CPRD Aurum.
Objective 2: 1ï° To examine the likelihood of a BI occurring according to consultation mode: a) face to face vs remote (modes combined) b) face to face vs i. telephone and video and ii. text and email. 2ï° To examine whether occurrence of BI delivery differs by age, ethnicity, gender or IMD i. overall ii. by consultation mode.
Study population
Adults (18+) registered with a general practice in England from 1/1/2019 â 31/12/2022.
Primary exposures and outcomes
1: Exposure: Primary care consultation. Outcome: Consultation mode
2: Exposure: Consultation mode. Outcome: Advice or support (BIs).
Data sources
CPRD Aurum, ethnicity and IMD data
Study design and methods
1: Descriptive analysis (% agreement) of new consultation categorisation system compared to EMIS consultation categorisation with narrative synthesis of discrepancies.
2: An open cohort study using logistic regression analysis to calculate the odds of a brief intervention occurring face to face vs remotely
Public health benefit
Half of all smokers will die prematurely and 52% of cancer deaths are attributable to smoking. Health systems can address this is through preventive healthcare including BIs. Systematic reviews of randomised trials show that BIs are:
⢠effective and cost-saving for smoking cessation
⢠effective and cost-effective for reducing hazardous drinking and weight loss
⢠effective and may be cost-effective for physical inactivity
This study will quantify whether there is a difference in implementation of BI between consultation modes and population subgroups. If present, targeted strategies to increase implementation can be developed.
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Diabetic ketoacidosis (DKA) in adults newly diagnosed with type 1 diabetes (T1D) — Joht Singh Chandan ...
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Diabetic ketoacidosis (DKA) in adults newly diagnosed with type 1 diabetes (T1D)
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-17
Organisations:
Joht Singh Chandan - Chief Investigator - University of Birmingham
Joht Singh Chandan - Corresponding Applicant - University of Birmingham
Jonathan Hazlehurst - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Lauren Quinn - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of Birmingham
Punith Kempegowda - Collaborator - University of BirminghamOutcomes:
Objective 1: DKA rates in adults newly diagnosed with T1D
⢠Proportion of adults presenting with DKA at onset of T1D.Objective 2: Risk factors for DKA (see appendix 1 for full list)
⢠The risk factors of interest are: age, smoking, obesity, ethnicity, gender, socio-economic deprivation, comorbidities.
⢠Time to diagnosis of T1D from first key symptom: osmotic symptoms (polyuria, polydipsia)Objective 3: Outcomes of DKA
⢠Neuropathy, retinopathy, nephropathy, cardiovascular and stroke outcomes and mortalityDescription: Lay Summary
Type 1 diabetes (T1D) is a disease affecting persons of all ages. T1D is an autoimmune condition (where the body attacks itself) leading to a lifelong dependency on a medication called Insulin. Unfortunately, one in four children who have T1D are found to have it when they attend hospital with a complication called diabetic ketoacidosis (DKA). DKA is a life-threatening complication where the body doesn't have the right amount of sugar it needs and starts searching for other sources of fuel. However, we don't currently know of the people who develop T1D in adulthood, whether they also come to the hospital with this complication.
Hence, we will use GP records and hospital data to see how frequently DKA occurs at the point of diagnosis for adult-onset T1D. If we can see who is affected and when, it can help us plan services to try and support these patients earlier so they don't have to come to hospital with such a severe complication.
Linked to this, using the same data, we also plan to see if we can find out the risk factors for attending hospital with DKA at the point of their T1D diagnosis. Lastly, we also want to see how their future health is if they have been diagnosed as such with DKA and T1D compared to people who did not develop T1D in this way. Undertaking these analyses will help us understand more about this condition and support these patients better.
Technical SummaryType 1 diabetes (T1D) is an autoimmune condition leading to insulin dependency. T1D incidence is equivalent throughout the first six decades. In the UK, 25% of children present as an emergency in diabetic ketoacidosis (DKA). DKA is associated with a 0.15-0.3% mortality. Short and long-term sequelae of DKA, include neurocognitive changes in the proceeding 6-12 months and poorer glucose control. In children, predisposing factors for DKA include deprivation, ethnic minority background and higher HbA1c at diagnosis.
The incidence of DKA in adults newly diagnosed with T1D and predisposing factors remain unclear. A UK biobank study reported similar rates of DKA in individuals newly diagnosed with T1D aged under 30 years (9%), compared to 11% in 31-60 year olds. However, T1D diagnosis in adults over 30 years is challenging due to higher prevalence of type 2 diabetes (T2D). This diagnostic uncertainty likely contributes to the paucity of data on incidence of DKA at onset of T1D in adults.
We are planning to undertake a comprehensive exploration of the epidemiology of DKA at disease onset in adults with T1D using the CPRD GOLD, AURUM and linked HES datasets from 1st Jan 2001-latest data available. We will undertake a case-control study comparing adults with DKA at diagnosis (cases) against those without (control). We will use logistic regression to identify the odds-ratio of pre-determined risk factors (exposures). Following this, using a retrospective cohort study design, we will examine the risk of patients with DKA (exposed) at diagnosis developing subsequent illnesses compared to those without DKA (unexposed). We will examine risk of microvascular complications and macrovascular complications.
Benefits: 1) Describing the burden of DKA in adult-onset T1D will help with healthcare service planning and provide opportunities to reduce inequalities, and 2) Increased knowledge of subsequent morbidity will provide opportunities to tailor preventative advice and therapy.
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Epidemiology of intraoperative and postoperative complications in patients undergoing left-sided colorectal surgery for benign or malignant colorectal disease in England — Guy Cafri ...
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Epidemiology of intraoperative and postoperative complications in patients undergoing left-sided colorectal surgery for benign or malignant colorectal disease in England
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-31
Organisations:
Guy Cafri - Chief Investigator - Johnson & Johnson Innovation ( JJDC, Inc )
Guy Cafri - Corresponding Applicant - Johnson & Johnson Innovation ( JJDC, Inc )
Goran Ribaric - Collaborator - Johnson & Johnson Medical GmbH (Germany)
Jennifer Wood - Collaborator - Johnson & Johnson Medical Devices & Diagnostics Global Services, LLC (USA)
Paul Coplan - Collaborator - Johnson & Johnson Medical Devices & Diagnostics Global Services, LLC (USA)
Rebekah Blakney - Collaborator - Johnson & Johnson ( JnJ - USA )Outcomes:
Primary outcome: a composite of 16 intraoperative and postoperative complications within 30 days post-index procedure date:
o Anastomotic leakage
o Anastomotic bleeding
o Cardiac arrest
o Coma
o Deep vein thrombosis
o Myocardial infarction
o Postoperative ileus and intestinal obstruction
o Pneumonia
o Postprocedural gastrointestinal bleeding
o Pulmonary embolism
o Sepsis
o Stenosis and/or stricture
o Stroke
o Surgical site infection
o Wound disruption and/or burst abdomen
o DeathSecondary outcomes
1) 30-day re-admission for any reason
2) Post-procedure hospital length of stay during the index admissionDescription: Lay Summary
Colorectal cancer, also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). In the UK, more than 40,000 people a year are diagnosed with colorectal cancer making it the fourth most common cancer. Surgery is one treatment option for colorectal cancer. As with any surgery, it's possible for complications to happen. The complications can affect the overall health and survival of the patient. Examples of possible complications after colorectal surgery include a leak where the surgeon has joined the ends of the colon together, bowel not working properly, infection, blood clots, bleeding and/or death.
Our study will use anonymous hospital and physician records of patients who had a colorectal surgery between 2014 and 2018. We will calculate the proportion of patients who had complications during the hospital stay when the colorectal surgery was performed and within 30 days after the surgery was completed. We will explore characteristics associated with surgical complications. This study will provide insight on how often a complication is going to happen after colorectal surgery. Our findings will inform strategies to improve patient safety.
Technical SummaryWith growing emphasis on surgical safety, it appears fundamental to comprehensively understand the intraoperative and postoperative complications including death in patients with left-sided colorectal surgery. A retrospective cohort study will be conducted using de-identified health records from three linked databases: the Hospital Episode Statistics Admitted Patient Care (HES-APC) database, the Clinical Practice Research Datalink (CPRD) GOLD and Aurum database. The primary objective is to describe the overall cumulative incidence of the composite outcome, comprised of 16 intraoperative and 30-day postoperative complications, in patients undergoing left-sided colorectal surgery for colorectal cancer or benign disease in England. In addition, the study also aims to assess the cumulative incidence of hospital re-admission for any cause within 30 days post-index procedure discharge date and to describe the post-procedure hospital length of stay during the index admission.
Patients who underwent left hemicolectomy, sigmoidectomy, anterior rectal resection and Hartmann reversal procedures will be extracted from the HES-APC linkage between 1 January 2014 and 31 December 2018âthe last 5 years before ECHELON CIRCULAR⢠Powered Stapler was introduced to England. We will also require that patients be â¥18 years at the time of the index admission and were registered with a general practitioner (GP), whose office contributed data to the CPRD GOLD and Aurum for at least 6 months prior to the index procedure date and for at least 30 days following the index procedure date. Descriptive analyses will be performed to calculate cumulative incidences and 95% confidence intervals of the composite outcome comprised of 16 intraoperative and postoperative complications within 30 days post-index procedure (primary outcome) and 30-day hospital re-admission for any cause (secondary outcome). Post-procedure hospital length of stay during the index admission (secondary outcome) will be summarized by means, medians, and standard deviations. Our findings will inform strategies to improve surgical safety.
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Population-level incidence, prevalence and mortality rates in diseases of regulatory interest — Daniel Prieto...
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Population-level incidence, prevalence and mortality rates in diseases of regulatory interest
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-12
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Kim López-Güell - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Marta Pineda Moncusi - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
Incidence and/or prevalence of disease of regulatory interest, mortality rates (all-cause or disease-specific).
Diseases of regulatory interest: Respiratory Syncytial Virus in co-infection with other respiratory viruses
Description: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe.
One area of research relates to estimating how common a specific condition is among the general population. We will calculate how many people are affected by a condition during a specific period or time point ("prevalence"), and how many people were newly diagnosed with a condition during a specific time period ("incidence"). We will calculate these in subgroups of the population based on age and/or sex, and over calendar years or months to look at trends over time.
In addition, we will look at how many people die due to the condition of interest.The EMA will request several studies of the same design to assess how common a specific conditions are in the population and how many people die from these conditions. This will help the regulators to inform preventative measures that could be introduced to reduce disease spread or disease burden, and subsequently reduce risk for mortality for affected people wherever possible. The first example will focus on a specific respiratory virus âRespiratory Syncytial Virusâ in combination with other respiratory diseases such as COVID-19 or the flu.
Technical SummaryPrimary care records provide a unique source of data for estimating the population-level incidence and prevalence of specific diseases, and mortality rates in people affected by these diseases. The âData Analysis and Real World Interrogation Network (DARWIN EU)â initiative created by the European Medicines Agency (EMA) intends to draw upon such data for regulatory decision making: such studies could help to assess disease burden in the population, understand the impact of measures to reduce mortality in affected patients and, for rare diseases, provide the possibility of faster approval of new, innovative treatments through a different regulatory pathway for orphan medicines. EMA will therefore request several studies assessing the natural history of diseases.
Study design: Cohort study
Population: All people in CPRD GOLD and CPRD AURUM with >=1 year of prior history comprise the source population. Among those, people with the pre-specified disease of regulatory interest will be selected for survival analyses. Where the condition is typically requiring hospitalisation, we will use CPRD linked to HES. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Variables: Conditions will be identified based on SNOMED codes in the mapped data (CPRD and/or HES). Date of death will be retrieved from CPRD.
Diseases of regulatory interest:
- Respiratory Syncytial Virus in co-infection with other respiratory virusesAdditional diseases of regulatory interest will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
Analyses:
(1) Point or- period prevalence of the disease of regulatory interest
(2) Incidence of the disease of regulatory interest
(3) All-cause mortality rates among people with the respective disease
(4) Rates of death due to the disease of interest among people with the respective diseaseAll analyses will be stratified by age, sex, and calendar year where relevant.
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Incidence of gastro-intestinal, lower respiratory tract, and acute otitis media infections in infants in the United Kingdom between 2012 and 2022. — Jonathan Wray ...
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Incidence of gastro-intestinal, lower respiratory tract, and acute otitis media infections in infants in the United Kingdom between 2012 and 2022.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-09
Organisations:
Jonathan Wray - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Incidence of gastro-intestinal infections in infants under one; incidence of lower respiratory tract infections in infants under one; incidence of acute otitis media infections in infants under one
Description: Lay Summary
The National Institute for Health and Care Excellence (NICE) is updating its guideline on Maternal and Child Nutrition, expected to be published in 2024. As part of the guideline development, an economic analysis is being conducted, to assess the value for money of education and support interventions that promote breastfeeding. To support this work and ensure that recommendations made are relevant to the current clinical landscape, committees need to see the economic analysis being populated with the most recent rates of three common infections in infants under one year of age (as there is evidence that rates for these infections at this age are reduced with increasing breastfeeding rates).
This work will look at the General Practice (GP) records of babies under one year of age and measure the number of new cases of three common infections to provide a rate for each of these. The three infections considered are: gastro-intestinal (GI) infections, which are infections affecting the stomach and digestive system, lower respiratory tract infections (RTI), which affect the breathing system, and otitis media, which are middle ear infections. For each of these conditions, we will measure the number of new cases every year from 2010-2022 to understand how this is changing over time.
Measuring these infection rates and using them to populate the Maternal and Child Nutrition Guideline economic analysis will help the NICE committee reviewing the guideline to formulate public health recommendations in the care of babies.
Technical SummaryThe National Institute for Health and Care Excellence (NICE) is updating its guideline on Maternal and Child Nutrition, expected to be published in 2024. As part of the guideline development, an economic analysis is being conducted, to assess the cost-effectiveness of education and support interventions that promote breastfeeding. To support this work and ensure that recommendations made are relevant to the current clinical landscape, committees need to see the economic analysis being populated with the most recent data on the incidence of three common infections in infants under one year of age (as there is evidence that rates for these infections at this age are reduced with increasing breastfeeding rates).
A retrospective observational cohort study will be conducted using the Clinical Practice Research Datalink (CPRD) Aurum UK primary care database. We will measure incidence rates for three common infections: acute otitis media, lower respiratory tract infections, and gastrointestinal infections. For each of these conditions, annual incidence rates will be calculated between 2010 â 2022, to understand how these are changing over time. For each year, incidence will be calculated using the number of events divided by the total contributing person-time in years. This will be reported per 100,000 person-years.
These incidence rates will be used to provide accurate and up-to-date information to populate the Maternal and Child Nutrition guideline economic analysis, the results of which will be considered by the NICE committee when formulating recommendations. This will ensure that resulting recommendations are relevant to the current UK clinical setting and improve standards of care for infants.
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Sodium-glucose co-transporter 2 inhibitors vs dipeptidyl peptidase-4 inhibitors and the risk of ventricular arrhythmia among patients with type 2 diabetes: A population-based cohort study — Samy Suissa ...
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Sodium-glucose co-transporter 2 inhibitors vs dipeptidyl peptidase-4 inhibitors and the risk of ventricular arrhythmia among patients with type 2 diabetes: A population-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-19
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
WANG-CHOI TANG - Collaborator - McGill UniversityOutcomes:
Ventricular arrhythmia (fatal or non-fatal) and cardiac arrest (fatal or non-fatal).
Description: Lay Summary
Sodium-glucose cotransporter 2 (SGLT2) inhibitors represent the newest class of medication in the management of type 2 diabetes (a condition characterized by elevated blood sugar levels). They have been widely adopted in clinical practice due to their ability to prevent major adverse cardiovascular events. This is an endpoint that includes heart attacks, strokes, and heart-related death. However, the mechanism responsible for the reduced risk of heart-related death remains unclear. Recent studies suggest that SGLT2 inhibitors might achieve this by reducing the risk of ventricular arrhythmia (VA), a heart rhythm disorder that can be fatal.
We will conduct a study that compares the occurrence of VA among patients with type 2 diabetes who use SGLT2 inhibitors to the occurrence among patients who use dipeptidyl peptidase-4 (DPP-4) inhibitors (another drug class used to treat type 2 diabetes) to assess whether SGLT2 inhibitors reduce VA. We will also compare the risks of fatal VA and cardiac arrest (when the heart stops beating) among patients using these medications. We will also determine if results vary by age, sex, duration of treated type 2 diabetes, history of heart disease, glycated haemoglobin A1c level (a measure of blood sugar control), and user type (new users vs users who have been using the medication). We will also determine if there is a duration-response association between the use of SGLT2 inhibitors and DPP-4 inhibitors and the risk of VA.
Technical SummaryDespite the established reduction in cardiovascular death associated with sodium glucose co-transporter 2 (SGLT2) inhibitors, the mechanism responsible for this effect remains unclear. Recent studies indicate that SGLT2 inhibitors may reduce the risk of atrial fibrillation, implying a potential positive influence on heart rhythm. However, their effects on ventricular arrhythmic (VA), another type of fatal heart rhythm disorder, remains poorly understood.
We will conduct a population-based cohort study using a prevalent new user approach and data from the United Kingdom Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics, and Office for National Statistics. We will include patients with type 2 diabetes who received a SGLT2 or dipeptidyl peptidase-4 (DPP-4) inhibitor between January 1, 2013, and December 31, 2022. In the primary analysis, exposure will be defined using an as-treated definition in which patients will be followed until VA, departure from the CPRD, death, end of the study period, or treatment discontinuation. The primary analysis will use Cox proportional hazards models to estimate hazard ratios for VA with SGLT2 inhibitors vs DPP-4 inhibitors. Secondary analyses will compare the risks of fatal VA and cardiac arrest between the two groups. We will examine if age, sex, duration of treated type 2 diabetes, history of cardiovascular disease, glycated haemoglobin level, and user type modify our primary estimates. We will also assess if there is a duration-response association between the use of these medications and the risk of VA. To minimize confounding, SGLT2 inhibitor users will be matched to DPP-4 inhibitor users 1:2 on age, sex, and duration of treated diabetes without replacement on nearest time conditional propensity score in chronological order.
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Establishing the baseline data to support research for the prevention of primary diabetic foot ulcers — Francesca Crowe ...
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Establishing the baseline data to support research for the prevention of primary diabetic foot ulcers
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-29
Organisations:
Francesca Crowe - Chief Investigator - University of Birmingham
Francesca Crowe - Corresponding Applicant - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Nachiappan Chockalingam - Collaborator - University of Birmingham
Panagiotis Chatzistergos - Collaborator - University of BirminghamOutcomes:
Primary:
⢠Diabetic foot ulcer.
Secondary:
⢠Amputation (Lower limb)
⢠Mortality (all-cause)Sample SNOMED CT code lists (CPRD Aurum) for DFU and amputation are attached as appendices. We are in the process of adapting these lists for the purpose of the present project. Final code lists will also be converted to Readcodes for CPRD Gold database.
Description: Lay Summary
People with diabetes (high blood sugar levels) can lose the ability to feel pain in their feet causing injuries and open wounds called diabetic foot ulcers. These ulcers donât heal easily and can get infected which can lead to an amputation. Stopping the first foot ulcer from happening can help protect people with diabetes from lower limb amputation, but there is a lack of research in this area.
We aim to:
1. Assess whether the chance of having a foot ulcer in people with diabetes (type 1/2) differs by age, gender, ethnicity, socioeconomic group, geographical region, body mass index (BMI), presence of other diabetes complications such as problems with heart, kidneys or eyes, or foot problems.
2. In people with diabetic foot ulcer, assess what factors increase the chance of having an amputation or dying.To do this, we will study a group of people who have diabetes (type 1/2) and have never had a foot ulcer or amputation. We can see how factors like age, where they live, and their background might affect the risk of getting a foot ulcer. Then, among people with diabetic foot ulcers, we will look factors like age, where they live, and their background might affect the risk of having an amputation or dying.
This research will help us make better plans to reduce foot ulcers and other serious problems in people with diabetes. This will benefit people with diabetes and reduce the cost of foot ulcers to the NHS.
Technical SummaryPreventing the first incident of diabetic foot ulceration (DFU) from happening is the most effective way to protect people with diabetes against lower limb amputation. However, research in this area is lacking.
Objectives:
1: Assess whether the risk of developing a first DFU in people with diabetes (type 1/2) differs by demographic factors (e.g. age, sex, ethnicity, socioeconomic group, geographical region), anthropometric parameters (e.g. BMI) or by the presence of other relevant diabetes complications (e.g. peripheral neuropathy, peripheral vascular disease, renal failure, retinopathy) or foot problems (e.g. history of callus, foot deformity).
2: Assess the impact of DFU on mortality and whether the risk of having an amputation and/or dying differs in people with diabetes according to the time they develop the first DFU.Study design, analysis:
1) A retrospective cohort of people with diabetes (type 1/2) with no history of DFU or amputation will be followed from the time of diabetes diagnosis to calculate the incidence of primary DFU. Time-to-event analysis (e.g. Cox regression) will be conducted to select the factors that are associated with a greater risk of primary DFU. Primary DFU rates, will be estimated across the follow-up period (2005-2022) and differences in trends (over time) between groups (e.g. ethnicity, socioeconomic status, geographical region) will be explored.
2) The incidence of amputation and mortality will be assessed in the same cohort. Associations between the age at which a person develops their first DFU and the age at which they have an amputation or the age at which they die will be assessed (e.g. Cox regression). The effect of diabetes type, duration of diabetes, sex, ethnicity, and index of multiple deprivation and of parameters known to affect mortality (e.g. BMI, smoking, diabetic control including measures of HbA1c and use of antidiabetic medications, other comorbidities) will be also considered.
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Association between leukotriene receptor antagonist use and the risk of dementia: a population based cohort study — Wallis Lau ...
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Association between leukotriene receptor antagonist use and the risk of dementia: a population based cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-09
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Boqing Chen - Corresponding Applicant - University College London ( UCL )
Chengsheng Ju - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
The hazard ratio (HR) and absolute risk difference of dementia for LTRA treatment vs. LABA treatment.
Description: Lay Summary
Dementia is a group of diseases associated with an ongoing decline of brain functioning that can result in loss of thinking ability, memory, attention, logical reasoning, and other mental abilities. Dementia imposes substantial health, social, and economic burdens on individuals, families, and communities. Globally, approximately 50 million individuals are currently living with dementia. With the ageing population, this figure is anticipated to surge to 152 million by the year 2050.
Cognitive decline is one of major manifestations of dementia. Current treatments for dementia are limited, and most of the available treatment options for dementia primarily address its symptoms. There is a need to explore new treatment options. Leukotriene receptor antagonists (LTRAs) are a class of medicines used to prevent the symptoms of asthma and seasonal allergies. There is evidence from animal studies that LTRA use may delay the progress of dementia and maintain cognitive function. However, the effects of LTRA in preventing dementia in humans have not been well studied.
This study aims to assess the effect of LTRAs in reducing the risk of dementia at the population level. The results of this study will allow us to better understand the potential of developing LTRAs for preventing and treating dementia.
Technical SummaryWith the aging of the global population, the prevalence of dementia is becoming a significant public health concern. Currently, there is no cure for dementia. Leukotriene receptor antagonists (LTRAs) are currently being used for the treatment of asthma and seasonal allergies. Preclinical animal studies suggested that LTRAs may alleviate the dementia pathology, restore the cognitive function in aged rats and may be effective in treating dementia.
This study aims to evaluate the association between LTRA use and dementia among patients with asthma, using data from CPRD. The Hospital Episode Statistics (HES) data will be used for capturing hospital diagnosis of dementia and potential confounding factors. The Office of National Statistics (ONS) data will be used to determine death. Linkage to Index of Multiple Deprivation will be used to control for the confounding from socioeconomic status.
This study will follow the target trial emulation framework to compare the effect of LTRAs with long-acting beta-agonists (LABAs, another class of medicines for asthma). Patients with asthma who initiated LTRA and LABA between 1 January 2005 and 31 December 2021 will be included. First, the new users of LTRAs will be compared with the new users of LABAs. Then, among those who initiated LABA, subsequent target trials will be emulated based on the time since LABA initiation to compare those who remained on LABA to those who added or switched to LTRA. Both intention-to-treat and per-protocol analyses will be conducted. Hazards ratios (HRs) will be approximated using pooled logistic regression models. Inverse probability treatment weighting (IPTW) will be used to account for the baseline confounding. Inverse probability of censoring weighting (IPCW) will be used to address the selection bias induced by artificial censoring in the per-protocol analysis. A pooled logistic regression model will be used to pool data over all emulated trials.
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Understanding and Preventing Epilepsy Inequalities in the UK — Kathryn Bush ...
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Understanding and Preventing Epilepsy Inequalities in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-29
Organisations:
Kathryn Bush - Chief Investigator - Newcastle University
Kathryn Bush - Corresponding Applicant - Newcastle University
Andrew Kingston - Collaborator - Newcastle University
Rhys Thomas - Collaborator - Newcastle University
Sheena Ramsay - Collaborator - Newcastle University
William Owen Pickrell - Collaborator - Swansea UniversityOutcomes:
Cause specific epilepsy incidence rates; incident rate ratios; mean and median age of epilepsy onset; rates of underlying epilepsy aetiologies (where a pathological cause has been identified); rates of preventable/modifiable epilepsy aetiologies; rates of all-cause mortality; rates of disease-specific mortality; rates of preventable/modifiable mortality; mean/median age of rates of adverse events (e.g. emergency admissions or pregnancy on a higher risk anti-seizure medication); hazard ratios for mortality; odds of developing epilepsy according to risk factors; population attributable risk factors.
All outcomes will be presented overall and per IMD decile/quintile (as long as no small numbers present â these numbers will be supressed). Results will be stratified according to age of epilepsy onset, age of adverse events, sex, ethnicity (where possible), rural/urban populations, lifestyle and behavioural factors.
Description: Lay Summary
Epilepsy is a chronic medical condition that causes people to have seizures (fits). We know that people who have epilepsy are more likely to die at a younger age than people without epilepsy. There is some evidence that people living in the most deprived (poorest) areas of the United-Kingdom (UK) are more likely to have epilepsy and more likely to experience adverse (bad) health outcomes. However, the full extent of these differences isn't known, and we do not understand why these differences occur.
These differences, in terms of who gets epilepsy, and their health outcomes, are known as 'health inequalities'. We will explore these differences, because once we understand inequalities in epilepsy, we can design public health interventions to try and reduce them.
This research will be carried out using medical records from GPs, hospitals and death records, we will look at epilepsy, and its adverse outcomes including deaths, according to the levels of deprivation in the places where people with epilepsy live. We will use statistical methods to assess these inequalities.
By the end of this research, we hope to understand the relationship between epilepsy and levels of deprivation. We will then consider what could be done to reduce the numbers of epilepsy cases, adverse outcomes and deaths in people with epilepsy.
The findings will be used to make recommendations about the way that care for people with epilepsy is provided and make public health recommendations to reduce epilepsy, with a focus on those groups at higher risk.
Technical SummaryUsing a population level approach, we will conduct cohort and case-control studies to understand the factors underlying the association between socioeconomic deprivation and i) incidence of cause-specific epilepsy, ii) epilepsy mortality and iii) adverse epilepsy outcomes, in the United Kingdom.
Longitudinal cohort study: Individuals with epilepsy defined as: diagnostic code in CPRD or HES data and (adults only) 2 prescription codes for an anti-seizure medication within +/- 12 months). Area-level (lower super output area) IMD-scores will be used as proxy for deprivation.
HES and CPRD data will provide information regarding aetiologies, comorbidities, behavioural-factors, and adverse outcomes including: unscheduled emergency care for epilepsy, polypharmacy, high risk anti-seizure medications in women of reproductive age/pregnancy, and cardiovascular or psychiatric comorbidities.â¯
Mortality records will be used to determine age and cause of death and understand differences in life expectancy by deprivation.
Epilepsy incidence, risk-factors/aetiologies (underlying pathological cause), the age and cause(s) of death and adverse outcomes will be analysed descriptively, according to: deprivation, age of epilepsy onset, sex, ethnicity and rural-urban populations.â¯
Adjusted cox proportional hazards models will analyse time-to-epilepsy incidence, calculate hazard ratios and provide quantitative measures of the relative risk of event occurrence between groups. Kaplan Meir survival curves from epilepsy diagnosis to death will be used to examine the association, stratified according to deprivation, and reported using cox-proportional hazard ratios.
Case-control study: We will examine the factors underlying the demonstrated associations. Epilepsy cases will be matched 3:1 (to non-epilepsy cases) by age, sex and deprivation. Logistic regression models will examine the associations between deprivation and epilepsy, and adverse outcomes. Population attributable risk and fractions calculated.
Once inequalities have been mapped, we will consider to what extent the outcomes are potentially preventable through intervention(s) and targeting specific factors. We will use this data to influence Public Health policy and reduce inequalities.
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Comparing the Risk of Interstitial Lung Disease Between Oral Anticoagulants in Patients with Atrial Fibrillation: A Population-Based Cohort Study — Wallis Lau ...
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Comparing the Risk of Interstitial Lung Disease Between Oral Anticoagulants in Patients with Atrial Fibrillation: A Population-Based Cohort Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-08
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Jan Chobanov - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Olivia Bryant - Collaborator - University College London ( UCL )Outcomes:
Interstitial Lung Disease
Description: Lay Summary
Atrial fibrillation (AF) is a heart condition that promotes the formation of blood clumps which can block blood supply to the brain causing stroke, a serious and life-threatening condition. Oral anticoagulants, also known as blood thinners, are often offered to patients with AF to prevent stroke. Historically, oral anticoagulants called warfarin were commonly used, but newer and safer types of blood thinners called direct oral anticoagulants (DOACs), are now recommended over warfarin. Despite DOACs superior safety compared to warfarin, recent studies have linked DOACs to interstitial lung disease (ILD), a group of rare conditions which often cause serious complications in the lungs such as scarring. These complications can lead to breathing difficulties and death. Limited research has investigated this important safety concern; it is uncertain whether DOACs may increase the risk of ILD, or which patient groups may be most at risk of ILD with DOACs.
This study will use de-identified electronic databases to assess whether DOACs may increase the risk of ILD compared to warfarin in patients with AF. We will also compare the risk of ILD between DOACs. Furthermore, we will explore if certain patient groups may be more at risk of ILD with DOACs. These findings can inform whether guidelines should be aware for ILDs in patients with AF using DOACs. This would help prevent potentially DOAC-induced ILDs and allow timelier medical intervention.
Technical SummaryAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia which increases the risk of embolic events such as ischaemic stroke. Direct oral anticoagulants (DOACs), which are at least as effective as warfarin with superior safety regarding adverse bleeding events, are recommended as the choice of oral anticoagulation for patients with AF. However, case reports, pharmacovigilance data and a recent observational study have linked DOACs, specifically FXa inhibitors, to an increased risk of interstitial lung disease (ILD). We will use the Clinical Practice Research Datalink, linked with Hospital Episode Statistics and Office of National Statistics, to investigate the association between DOACs and ILD.
This is a retrospective cohort study designed using the target trial framework. Patients with AF who initiated oral anticoagulants between 1 January 2012 and 31 December 2022 will be included in the study. We will compare the risk of ILD with DOAC vs warfarin as well as between DOACs. To control for confounding, we will use inverse probability treatment weights (IPTW). Propensity scores will be calculated using generalised boosted models, an iterative machine-learning algorithm. For each pairwise comparison, we will fit IPTW weighted Cox Proportional Hazards models to obtain adjusted hazard ratios. IPTW weighted pooled logistic regressions will be used to compute standardised risk curves for ILD at monthly intervals. Subgroup analyses will be performed to observe if certain patient groups may have increased ILD risk associated with DOACs. These findings can help inform whether guidelines should promote vigilance in monitoring for ILDs among patients with AF using DOACs, helping prevent DOAC-induced ILDs.
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The effect of major adverse cardiovascular events in people with Chronic Obstructive Pulmonary Disease (COPD) on future COPD exacerbations, future cardiovascular events, and mortality — Jennifer Quint ...
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The effect of major adverse cardiovascular events in people with Chronic Obstructive Pulmonary Disease (COPD) on future COPD exacerbations, future cardiovascular events, and mortality
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-26
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Anne Ioannides - Corresponding Applicant - Imperial College LondonOutcomes:
1. COPD exacerbations, including:
a. As a binary outcome (exacerbation versus no exacerbation);
b. COPD severity (moderate, managed in primary care; or severe, managed in secondary care);
c. COPD exacerbation count over follow-up;2. Major adverse cardiovascular events (MACE), defined in secondary care only, including:
a. Acute coronary syndrome (ACS);
b. Arrhythmia;
c. Heart failure (HF);
d. Ischaemic stroke (stroke);3. Mortality, defined by ONS data, including:
a. All-cause;
b. COPD-specific;
c. Cardiovascular-specific.Description: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease. Symptoms include cough, sputum, and breathlessness. The main cause of COPD is smoking. We know that people who have COPD also often also have cardiovascular diseases. People with COPD die more from heart-related events than lung-related events. There is also a relationship between COPD exacerbations (sudden worsening of COPD symptoms, beyond day-to-day variations, often requiring treatment) and major cardiovascular events (such as heart attacks and heart failure), where cardiovascular events are more likely to occur after a COPD exacerbation. What we do not know, however, is whether there a COPD exacerbation is more likely to happen after a cardiovascular event. We also do not know whether the type of cardiovascular event (such as heart attacks, strokes, heart rhythm problems, or heart failure) results in differences in subsequent COPD exacerbations, cardiovascular events, or death.
Using routinely collected electronic healthcare records from both GP practices and hospitals, this research aims to understand the effect of cardiovascular events in COPD patients on their future (i) COPD exacerbations, (ii) cardiovascular events, and (iii) death. We would also like to examine whether the type of cardiovascular event (such as heart failure, or heart rhythm problem, or stroke) influences future COPD exacerbations, cardiovascular events, or death.
Technical SummaryChronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disease, characterised by airway obstruction. Cardiovascular disease (CVD) is highly prevalent amongst people with COPD. There is a well-established association between COPD and CVD, including evidence that the risk of major adverse cardiovascular events (MACE) is significantly increased following a COPD exacerbation (acute amplification of COPD symptoms, beyond the day-to-day variations). Furthermore, COPD exacerbation severity mediates the exacerbation-MACE relationship: severe exacerbations result in greater MACE risk than moderate exacerbations. What is unknown is whether the reciprocal is true: whether MACE alters risk of COPD exacerbations, and whether MACE alters the risk of COPD exacerbation severity. We also do not know whether the type of MACE (such as acute coronary syndrome [ACS], arrhythmia, heart failure [HF], or ischaemic stroke) mediates the risk of subsequent COPD exacerbation, MACE, or mortality in people with COPD.
Using Clinical Practice Research Datalink (CPRD) Aurum primary care data, linked with Hospital Episode Statistics (HES) secondary care data and Office of National Statistics (ONS) death data, we will conduct a cohort study between 1 January 2010 and 31 December 2022 (or to the end of available linked data) on people with a validated COPD diagnosis. Within people with COPD, compared by whether or not people have had a MACE (ACS, arrhythmia, HF, or stroke), we will investigate the risk of (i) future COPD exacerbation and (ii) mortality. Additionally, we will stratify COPD exacerbation outcomes by COPD severity, and stratify mortality by cause (all-cause, COPD-specific, or cardiovascular-specific). To address whether MACE subtype mediates adverse outcomes in people with COPD, we will also stratify our MACE exposure (ACS versus no ACS, arrhythmia versus no arrhythmia, HF versus no HF, and stroke versus no stroke) to investigate how individual MACE subtypes affect risk of future COPD exacerbations, subsequent MACE, and mortality.
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Exploring Healthcare Use Trajectories and the Impact of Duloxetine on Pain-Related Healthcare Use in People with Fibromyalgia: Cohort Study and Emulated Trial in CPRD Aurum. — Ian Scott ...
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Exploring Healthcare Use Trajectories and the Impact of Duloxetine on Pain-Related Healthcare Use in People with Fibromyalgia: Cohort Study and Emulated Trial in CPRD Aurum.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-12
Organisations:
Ian Scott - Chief Investigator - Keele University
Sara Muller - Corresponding Applicant - Keele University
Ailish Byrne - Collaborator - Keele University
Helen Twohig - Collaborator - Keele University
James Bailey - Collaborator - Keele UniversityOutcomes:
STUDY 1
(a) All-cause primary care consultation rates; (b) all-cause hospital admission rates; (c) counts for drug prescriptions; (d) counts for investigations; (e) counts for referrals.STUDY 2
(a) Pain-related consultation rates; (b) hospital admission rates for a primary code of fibromyalgia, (c) number of different prescribed pain medicines.Description: Lay Summary
Fibromyalgia is a long-term condition causing persistent pain throughout the body. It is common and affects 1 in 20 people. Fibromyalgia is thought to result from abnormal levels of certain chemicals in the bodyâs nerves, which change how people with fibromyalgia experience pain.
As people with fibromyalgia frequently experience many different symptoms, they often use many healthcare services. They often see their GPs, have tests to investigate their symptoms with normal results, and are treated with lots of ineffective pain medicines. This can be very frustrating for people with fibromyalgia, who are best served by receiving education about their condition, exercise, talking-type treatments, and potentially anti-depressant medicines. It is also an ineffective use of healthcare resources. Understanding how to reduce excessive healthcare use in people with fibromyalgia is important.
This project will help us better understand how people with fibromyalgia use English primary care services. Its findings could be used to help plan healthcare services for people with fibromyalgia. It involves two related studies.
Study 1 will explore if there are groups of people with a recent diagnosis of fibromyalgia that use a lot of healthcare services over time and see how they may differ from groups of people that use less healthcare services (for example, by their age or gender).
Study 2 will compare two possible medicines for pain in fibromyalgia (duloxetine and amitriptyline) to see if one is better than the other at reducing how people with fibromyalgia use healthcare services for pain.
Technical SummaryBACKGROUND
Fibromyalgia is a long-term condition, characterised by widespread pain and a broad range of other symptoms. It is common, affecting up to 5% of the general population.Whilst people with fibromyalgia have high healthcare use levels, it is unknown how this may vary across groups of people with fibromyalgia, nor the impacts of treatment with duloxetine - an antidepressant widely used to treat this condition, shown to improve pain intensity scores in clinical trials - on pain-related healthcare use. Understanding this is important to optimising healthcare service provision to people with fibromyalgia in the English NHS.
OBJECTIVE
To explore how healthcare use differs between groups of people with fibromyalgia, and to examine the potential impact of treatment with duloxetine on pain-related healthcare use in this patient population.AIMS
1. Explore the presence of distinct classes of healthcare use trajectories in people with incident fibromyalgia, and compare the pain-specific, comorbid, and sociodemographic characteristics of members of different classes.2. Compare pain-related healthcare use between people with fibromyalgia following newly initiating duloxetine and amitriptyline.
METHODS
Two studies will be conducted using data from English practices in CPRD Aurum.First, a cohort study will address aim 1, using latent class growth analysis to investigate the existence of distinct classes of people with different trajectories of healthcare use (consultation/admission rates; counts of prescriptions/investigations/referrals). Baseline sociodemographic, pain-specific, and comorbidity characteristics of each trajectory class at cohort entry will be descriptively compared between classes.
Second, an emulated trial will address aim 2, comparing pain-related healthcare use (rates of pain-related consultations/admissions for fibromyalgia [defined using Hospital Episode Statistics data]; analgesic prescription counts) between people with fibromyalgia newly initiating duloxetine to people newly initiating amitriptyline. Confounding variables will be accounted for via an active comparator design and propensity scores.
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Exploring the impact of a drug safety update on the use of dapagliflozin in type 1 diabetes mellitus — Sophie Scanlon ...
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Exploring the impact of a drug safety update on the use of dapagliflozin in type 1 diabetes mellitus
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-31
Organisations:
Sophie Scanlon - Chief Investigator - MHRA
Sophie Scanlon - Corresponding Applicant - MHRA
Katherine Donegan - Collaborator - MHRAOutcomes:
Proportion of dapagliflozin prescribed for T1DM of all dapagliflozin prescriptions.
Description: Lay Summary
Diabetes is a condition that causes a person's blood sugar level to become too high. There are two main types of diabetes, type 1 is a lifelong condition requiring treatment with insulin, type 2 is more common, predominantly develops in adults and does not always require insulin. Dapagliflozin is a drug mainly used to treat type 2 diabetes, although it has been previously used in the treatment of type 1 diabetes. When used in treatment of type 1 diabetes additional warnings were required about the risk of a specific adverse event occurring more frequently in these patients. In 2021 the product license was changed and dapagliflozin could no longer be used in type 1 diabetes. Risk communication to healthcare professionals advised that dapagliflozin should be reviewed and discontinued in patients with type 1 diabetes. This change in the license was not due to any new safety concerns but was a commercial decision by the manufacturer.
Technical Summary
This studyâs purpose is to look at prescribing of dapagliflozin in type 1 diabetes both before and after the communication of the change to assess if a change in prescribing followed the advice. This will be done by calculating the proportion of dapagliflozin prescriptions that are given to patients with type 1 diabetes for each month over the study period (January 2019 to June 2023).
The rationale for the study is to find if there continues to be use of dapagliflozin in type 1 diabetes despite the previously required additional warnings no longer being available.Dapagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor which is predominantly used in the treatment of type 2 diabetes mellitus (T2DM). It previously had an indication for use in type 1 diabetes mellitus (T1DM), but this was removed by the marketing authorisation holder (MAH) in 2021, this change was communicated via a Drug Safety Update (DSU). This DSU advised that dapagliflozin should be reviewed and discontinued in patients with T1DM. This change in the license was not due to any new safety concerns but due to commercial reasons influenced by additional risk minimisation measures required for use in T1DM.
This descriptive study will look to explore the impact of the DSU by quantifying the use of dapagliflozin for the indication of T1DM both before and after the DSU was published. This will be done by calculating the proportion of dapagliflozin prescriptions that are given to patients with T1DM (as opposed to other indications) for each month over the study period. The study population will comprise all acceptable patients, in CPRD AURUM with at least one prescription for dapagliflozin issued between January 2019 and June 2023.
The rationale for this study is to explore if there continues to be off-label use of dapagliflozin in patients with T1DM. If so this will be without the additional risk minimisation measures that were previously in place and could represent a potential risk to patients.
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Epidemiology of Amyloidosis in the UK: A Retrospective Cohort Study using Clinical Practice Research Data Link (CPRD) — Richa Manwani ...
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Epidemiology of Amyloidosis in the UK: A Retrospective Cohort Study using Clinical Practice Research Data Link (CPRD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-29
Organisations:
Richa Manwani - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Daniel Carey - Corresponding Applicant - Alexion Pharma International Operations Limited (Ireland)
Ana Silva - Collaborator - Alexion Pharma Spain SL
Feifei Yang - Collaborator - Alexion Pharmaceuticals, Inc ( USA )
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Jil Billy Mamza - Collaborator - AstraZeneca Ltd - UK Headquarters
Pedro Laires - Collaborator - Alexion Pharma Spain SLOutcomes:
Primary outcomes: prevalence and incidence rates of amyloidosis and its subtypes in the UK; secondary outcomes: comorbidities of interest in amyloidosis (pre-specified) and comorbidities in general in amyloidosis; mortality rates associated with amyloidosis; treatments associated with amyloidosis.
Description: Lay Summary
Amyloidosis is an umbrella term for a group of rare and serious diseases that affect multiple organs throughout the body. The disease is caused by a build-up of a protein called amyloid in different tissues. This impairs organ function and can lead to organ failure. Commonly affected organs include the heart and kidneys. Among the several types of systemic amyloidosis, light-chain (AL) amyloidosis and Transthyretin amyloidosis (ATTR) are the most common. The overall disease (epidemiological) knowledge of systemic amyloidosis is scarce and inconsistent. Furthermore, the diagnostics for amyloidosis have improved over time, which may limit the value of some older studies and highlights the need to get more up-to-date epidemiologic data, particularly in the UK.
This study aims to provide an updated estimate of the extent (prevalence and incidence) of amyloidosis in the UK, overall and by major disease forms. This will enable a more detailed understanding of the disease and its impact in the country. This is expected to confer a public health benefit by establishing an up-to-date overview of the disease burden of amyloidosis overall and by subtype in the UK; this may help to increase rates of amyloidosis detection and treatment.
Technical SummaryAmyloidosis refers to a group of rare disorders of protein folding characterized by extracellular tissue deposition of misfolded and aggregated autologous proteins that have multi-systemic implications. There is a lack of current, large-scale studies about the epidemiology of amyloidosis in the UK. The aim of this study is to provide an updated estimate of the prevalence and incidence of amyloidosis in the UK, overall and by major systemic forms. The study population will be primary care patients within the UK, registered with a GP practice on or before January 1st 2012 and with an amyloidosis diagnosis recorded during the period January 1st 2012 to December 31st 2022. This is an observational, cross-sectional study using data collected from primary care, via patient encounters with their GP. Data sources for the study will be CPRD Gold and CPRD Aurum â linked with HES and ONS. Descriptive analyses will be applied to understand the comorbidities and the mortality associated with the study population; no inferential testing or statistical modelling will be performed. Descriptive analyses will include: estimation of prevalence and incidence rates; mortality rates; and summaries of the frequencies (i.e., Ns, %) of comorbidities and treatments for 365-day pre/post-index periods. The intended public health benefit of the study will be to help better understand the amyloidosis burden in the UK. This may be of benefit in the development of better patient identification and diagnosis strategies, together with improving amyloidosis clinical management and disease outcomes.
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Clinical outcomes and health resource use in people with controlled and uncontrolled chronic obstructive pulmonary disease (COPD) — Jennifer Quint ...
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Clinical outcomes and health resource use in people with controlled and uncontrolled chronic obstructive pulmonary disease (COPD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-31
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Philip Stone - Corresponding Applicant - Imperial College LondonOutcomes:
Major adverse cardiovascular events (MACE); Moderate exacerbations of chronic obstructive pulmonary disease (COPD); Severe exacerbations of COPD; Prescription of long-term oxygen therapy (LTOT); Forced expiratory volume in 1 second (FEV1) decline; Health care utilisation (HCU); Mortality.
Description: Lay Summary
Chronic obstructive pulmonary disease, called COPD for short, is a common disease that affects the lungs and causes breathlessness, cough, and phlegm. Many patients with COPD experience sustained periods of worsened symptoms, that are described as exacerbations. These exacerbations can lead to a spiral of further worsening symptoms and increase the risk of death. It is therefore desirable to find out who is at increased risk of experiencing an exacerbation of COPD so that there are more opportunities to prevent them. In this study we seek to understand how COPD patients who have exacerbations of different frequencies and severity differ to COPD patients who do not experience frequent exacerbations. This will benefit the public by highlighting groups of people with COPD who may be at greater risk of exacerbations and ultimately who may be eligible for new treatments.
Technical SummaryIn this study we aim to understand the clinical outcomes and healthcare resource utilisation (HCU) of chronic obstructive pulmonary disease (COPD) patients. We will use CPRD Aurum linked with patient-level IMD, HES APC, and ONS mortality data. The population will be patients aged â¥40 years with a validated COPD diagnosis, a smoking history, continuous registration at a GP practice, with acceptable data in the year before index, at least 1 day of follow-up prior to the outcome, and eligible for linkage to HES, IMD, and ONS. The inclusion and exclusion criteria from the BOREAS trial will be applied to the population as far as is possible using EHR data. We will use a cohort study design to investigate FEV1 decline, healthcare utilisation (HCU), mortality, and time to long-term oxygen therapy (LTOT), Major adverse cardiovascular events (MACE), next moderate exacerbation of COPD, and next severe exacerbation of COPD. We will also examine rates of MACE, and moderate and severe exacerbations. Cox or Poisson regression will be used for count variables, as appropriate. Mixed linear regression will be used to investigate the relationship between disease control and lung function decline over time. For HCU, fully parametric models (e.g. Weibell) will be used, as appropriate. This study will benefit public health by providing a greater understanding of factors associated with more frequent and more severe exacerbations of COPD and ultimately subgroups of COPD patients who may be eligible for new treatments.
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Incretin-based drugs and the incidence of endometrial cancer among patients with type 2 diabetes — Samy Suissa ...
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Incretin-based drugs and the incidence of endometrial cancer among patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-19
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sonny Rothman - Collaborator - McGill UniversityOutcomes:
An incident diagnosis of endometrial cancer, as determined by pre-specified Read codes, will be the primary outcome of interest. Endometrial cancer is well-recorded in the CPRD with a high positive predictive value (PPV); a validation study showed that 100% of endometrial cancer cases identified between 2004-2012 in the CPRD by Read diagnostic codes were confirmed by through clinical review of patient profiles.15 Endometrial cancer events occurring in the first year of follow-up will be censored as non-events in order to account for latency (i.e., as early events are unlikely associated with the exposure) and detection bias (i.e., there may be more frequent contact with the healthcare system in the weeks to months after initiation of a new drug therapy).
Description: Lay Summary
Glucagon-like peptide receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-4 (DPP-4) inhibitors are medications commonly prescribed to patients with type 2 diabetes (high blood sugar levels). Aside from their ability to effectively manage sugar levels in the body, these drugs have been shown to have several other clinical benefits. There is experimental evidence that these drugs can reduce the growth of uterine cancer cells in laboratory studies. However, it remains unknown whether these drugs are protective against cancer of the uterus using real-world data. Therefore, using a large population-based cohort, the goal of this study is to investigate the potential association between these drugs and the risk of uterine cancer among patients with type 2 diabetes. Seeing as type-2 diabetes is a high-risk factor for uterine cancer in females, the results of this study may render important clinical implications and support the use of these drugs for prevention of uterine cancer.
Technical SummaryGlucagon-like peptide receptor agonists (GLP-1 RAs) and dipeptidyl peptidase-4 (DPP-4) are anti-hyperglycemic agents commonly prescribed to patients with type 2 diabetes. These incretin-based drugs are known to have several beneficial pleiotropic effects including their ability to induce weight loss and lower the risk of hypoglycemia and cardiovascular events. Consequently, they are being proposed as preventative treatments and therapies for pathologies outside of the pancreas. There is novel experimental evidence that these drugs can inhibit the growth of endometrial cancer cells in vitro; however, there remains limited research on the association between the use of incretin-based drugs and the incidence of endometrial cancer in a real-world setting. Therefore, using a large population-based cohort from the Clinical Practice Research Datalink, the goal of this study is to investigate whether the use of GLP-1 RAs and DPP-4 inhibitors, separately, is associated with a decreased risk of endometrial cancer in females with type 2 diabetes. To do so, the study will compare incident users of either GLP-1 RAs or DPP-4 inhibitors with incident users of sulfonylureas from January 01, 2007 to December 31, 2021, with follow-up until December 31,2022. Propensity score fine stratification weighting will be used to control for confounding and hazard ratios with corresponding 95% confidence intervals will be estimated using Cox proportional hazard models. Visualization of the cumulative incidence of endometrial cancer for each exposure group will be displayed using weighted Kaplan-Meier curves. Seeing as obesity, insulin-resistance and diabetes are high risk factors for endometrial cancer, the results of this study may render significant clinical implications pertaining to the use of incretin-based drugs for chemoprevention of endometrial cancer in individuals with type 2 diabetes.
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Quantifying the impact of the COVID-19 pandemic and the Kidney Failure Risk Equation on Chronic Kidney Disease care and outcomes in Primary Care — Stuart Stewart ...
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Quantifying the impact of the COVID-19 pandemic and the Kidney Failure Risk Equation on Chronic Kidney Disease care and outcomes in Primary Care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-29
Organisations:
Stuart Stewart - Chief Investigator - University of Manchester
Stuart Stewart - Corresponding Applicant - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Philip Kalra - Collaborator - Salford Royal Hospital NHS Foundation
Smeeta Sinha - Collaborator - Salford Royal Hospital NHS Foundation
Tom Blakeman - Collaborator - University of ManchesterOutcomes:
Work Package 1: Measuring the Impact of COVID-19 Pandemic on CKD Care and Patient Outcomes
Primary Outcomes â see appendix 1
1. Number of patients with coded versus uncoded CKD prior to, during and after the COVID-19 pandemic
2. Completeness of CKD care in line with NICE CKD 2021 guidelines â see appendix 2
3. Major adverse renal events: new-onset kidney injury (persistent albuminuria/proteinuria and/or decreasing eGFR <60ml/min/1.73m2; sustained decline of > 50% in eGFR; development of ESKD < 15ml/min/1.73m2 with or without initiation of renal replacement therapy; acute kidney injury; death of renal cause.
4. Major adverse cardiac events: myocardial infarction; stroke; hospitalisation due to heart failure; death of cardiac cause
5. All-cause mortality
6. COVID-19 related death (death within 28 days of acute COVID-19 infection)Secondary Outcomes â see appendix 1
1. Stratification of findings to Kidney Research UK health inequality themes (age, sex, ethnicity, socioeconomic status, geography, mental health disease) â see appendix 1
2. Stratification of findings to indices of multiple deprivation deciles, and CCG level funding.
3. Prevalence of unscheduled care between patients with coded versus uncoded CKD: A&E attendances; All-cause hospitalisation; Length of hospital stay.
4. Population level outpatient nephrology appointments over timeWork Package 2: Predicting Missing Cases of CKD and their Correlation with Patient Outcomes and Unscheduled Care
Primary Outcomes â see appendix 1
1. Time to event of CKD diagnosis
2. Association between undiagnosed CKD and risk of: major adverse renal events; major adverse cardiac events; All-cause mortality; COVID-19 related death; Unscheduled care â A&E attendances
3. Association between time to event of CKD diagnosis and key independent variablesWork Package 3: Measuring the Impact and Performance of the Kidney Failure Risk Equation in NICE CKD guidelines in UK Primary Care
Primary Outcomes â see appendix 1
Impact
1. Number of patients with measurable KFRE scores pre and post-2021 NICE CKD guidelines update.
2. Number of advice and guidance referrals to nephrology pre and post-2021 NICE CKD guidelines update
3. Number of scheduled care appointments (outpatient appointments) to nephrology pre and post-2021 NICE CKD guidelines update.
4. Changes in major adverse renal events and major adverse cardiac events before and after inclusion of the KFRE in NICE guidelines.
Performance
1. Discrimination and calibration (as measured by area under the receiver operating curve) of the 4-variable, 5-year KFRE in underserved groups of patients with CKD (as measured using Kidney Research UK health inequality themes â age, sex, ethnicity, socioeconomic status, geography, mental health disease).Secondary Outcomes
1. Population-level changes of KFRE scores over time
2. Read code usage of 'kidney failure risk equation' in the electronic health recordDescription: Lay Summary
Chronic kidney disease (CKD) affects 700 million people globally. Two of the main causes of CKD are persistent and abnormally high blood sugars (also known as diabetes) and high blood pressure. Research shows the main causes of CKD are increasing, resulting in more people with CKD. 45,000 patients die each year in the UK due to CKD. Routine monitoring of kidney function and treating underlying causes of kidney disease are essential parts of CKD care. However, the COVID-19 pandemic has affected routine care, increasing the risk of worsening kidney disease. A new tool to help clinicians predict which patients are at greatest risk of kidney disease has been included in national guidelines however, it may not work fairly amongst all patients.
The aims of this study are to measure the impact of the COVID-19 pandemic on patient care for CKD patients; to measure what factors increase a patientâs risk of being missed; and to test if a new tool for predicting which patients are at greatest risk of kidney disease helps to improve patient care in a fair way. Using data from the Clinical Practice Research Datalink, we will analyse anonymised health record data from GP practices for patients across the United Kingdom before and after the COVID-19 pandemic. The findings will be shared with our patient and public involvement group and will be published in journals and presented at conferences. The findings will be also used to make recommendations to improve clinical care for patients with CKD.
Technical SummaryBackground
CKD is a global public health threat. Risk factors - diabetes and hypertension are increasing in prevalence. Early detection and monitoring are central to national and international CKD strategies. Financially incentivised monitoring of CKD ceased in 2015 in primary care. The COVID-19 pandemic disrupted healthcare delivery and with it routine chronic disease management vital for early detection, monitoring and management of CKD. National CKD audit data shows high variability in CKD care across the UK which results in major health inequalities. It is unclear which patients are at greatest risk of being missed. Predicting the risk of serious kidney disease is vitally important for patients and health systems alike, owing to the major human and financial costs of the disease. The Kidney Failure Risk Equation (KFRE) does this with high accuracy and was included in national NICE CKD guidelines - in August 2021. However, the KFRE lacks extensive validation in Black, Asian, and ethnic populations and its impact on patient and health system outcomes are unknown.Aims
1. Quantify the impact of the COVID-19 pandemic on CKD care and patient outcomes in UK Primary Care
2. Quantify missing cases of CKD, determine which factors increase the probability of undiagnosed CKD, and its impact on patient outcomes
3. Measure:
a. the impact of including the KFRE in national NICE CKD guidelines on patient and health system outcomes
b. the performance of the KFRE in underserved groupsMethods
We will conduct an interrupted time series to quantify the impact of the COVID-19 pandemic on CKD care. We will create a risk prediction model to determine which patients are at greatest risk of being missed, correlated with patient outcomes. We will quantify the impact of the KFRE model on patient and health system outcomes and performance of the KFRE in underserved groups.
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Exploring the Impact of Frailty Status on the Relationship Between Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2Is) and Adverse Cardiovascular Outcomes in Older People with Type 2 Diabetes — Iskandar Idris ...
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Exploring the Impact of Frailty Status on the Relationship Between Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2Is) and Adverse Cardiovascular Outcomes in Older People with Type 2 Diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-24
Organisations:
Iskandar Idris - Chief Investigator - University of Nottingham
Rami Aldafas - Corresponding Applicant - University of Nottingham
Kamlesh Khunti - Collaborator - University of Leicester
Thomas Crabtree - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
The study outcomes will include the following:
Primary endpoints :
⢠All-cause mortality
⢠Hospitalisation for heart failure (hHF)
Secondary endpoints :
⢠Nonfatal stroke
⢠Nonfatal Myocardial Infarction (MI)
⢠Diabeteic Ketoacidosis (DKA)Description: Lay Summary
Diabetes causes high blood sugar levels and can lead to health complications, including heart disease, Control of blood sugar level is important to reduce the risks of long-term health problems. Sodium-glucose cotransporter-2 inhibitors (SGLT2i), is a new class of treatment for people with type 2 diabetes. Research have shown that this class of treatments can reduce heart and kidney problems in addition to lowering blood sugar levels. Unfortunately, previous studies have not included older, frail patients due to the possible risk of side-effects. Their effectiveness in older, frail people therefore is not clear..
To address this, we aim is to compare the effectiveness of SGLT2i therapy with other diabetes medications among older, frail people with type 2 diabetes for the risks of developing heart and kidney complications as well as potential side-effects. The evidence of this study will better inform clinicians about the risks and benefits of SGLT2I treatment for older and frail people with type 2 diabetes
Technical SummaryObjective: This study will examine the association between initiating SGLT2Is and mortality or the risk of hospitalisation of heart failure in people with T2D, considering the frailty status.
Methods:
This will be a cohort study following patients on glucose-lowering therapy (GLT) between 1 January 2013 and January 2023. We will target individuals aged ⥠65 years at the first user episode of GLT including SGLT2Is, SU or DPP4Is and >1-year data history in the database. We will utilize linked data sourcesâHES and ONS mortality data. People with T2D without other GLT or with records of type 1 diabetes, gestational diabetes, polycystic ovary syndrome, insulin prescriptions, and history of human immunodeficiency, will be excluded. Patients will enter the cohort at the time of initiation of either SGLT2Is or other GLT as monotherapy and will be followed until the earliest: switching to another drug, leaving the practice/database, last date of data collection. We will form a sub-cohort of pateints who had a prescrition for an additional GLT and compare SGLT2 users (SGLT2is with SU or SGLT2Is with DPP4s) with patients on DPP4Is and SU (SU with DPP4Is or DPP4Is with SU). Separate analyses for different frailty groups based on the electronic frailty index (eFI) categorisation will be conducted. We will consider the following eFI categories: no frailty (eFI 0â0.12), mild frailty (eFI >0.12â0.24), moderate frailty (eFI >0.24â0.36), and severe frailty (eFI >0.36).Analysis:
Cox proportional hazards regression models will be used to estimate the Hazard Ratio (HR) for the outcome associated with SGLT2Is use compared to SU/DPP4Is use, adjusted for demographics, clinical measurements and conditions and other medications.We believe findings from this study will carry practical significance and will be of value to the public health by promoting the evidence-based utilization of SGLT2Is for older individuals with frailty and T2D.
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Apixaban Dosing and Clinical Outcomes for Patients with Non-valvular Atrial Fibrillation or Venous Thromboembolism — Chintan Dave ...
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Apixaban Dosing and Clinical Outcomes for Patients with Non-valvular Atrial Fibrillation or Venous Thromboembolism
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-24
Organisations:
Chintan Dave - Chief Investigator - Rutgers, The State University of New Jersey
Julia Liaw - Corresponding Applicant - Rutgers, The State University of New Jersey
Julia Liaw - Collaborator - Rutgers, The State University of New JerseyOutcomes:
Ischemic stroke or systemic embolism (all aims); cardiovascular specific mortality and hospitalizations (all aims); major bleeding and intracranial hemorrhage (all aims)
Description: Lay Summary
Anticoagulants are drugs that prevent blood clots in various medical conditions. One type, called direct oral anticoagulants (DOACs), with a focus on apixaban, is increasingly used, making up about 48-58% of anticoagulant prescriptions across different diseases. Researchers are also exploring their use in other medical conditions.
However, there's a lack of clear data on which DOAC to choose and the correct dosage. This can result in patients taking the wrong dose, potentially affecting outcomes like stroke, major bleeding, and survival.
This study aims to address these knowledge gaps. It will compare different DOACs to determine which is the most effective and safest. Researchers will also investigate the appropriate dosage for each DOAC. The focus will be on specific conditions like those involving heart rhythm issues or blood clots in veins. Using patient medical records over time, the study will assess how many people experience stroke with different treatments.
What's essential is that this research covers a wide range of diseases and outcomes, helping doctors and patients understand the best choice of DOAC and the right dosage for medical situations.
Technical SummaryAnticoagulants are frequently used for prevention of thromboembolic events, including ischemic stroke or systemic embolism, across a range of cardiovascular medical conditions. Among these, direct oral anticoagulants (DOACs), with a particular emphasis on apixaban, have garnered substantial usage, comprising approximately 48-58% of anticoagulant use across various indications, [1, 2] and are also being investigated for potential use in other diseases. [3-5] However, there is paucity of available data on the optimal selection of individual DOACs and the appropriate dosage, resulting in a notable prevalence of off-label DOAC dosing, [6] with consequential effects on clinical outcomes encompassing stroke, major bleeding events, and mortality. [7, 8] We will use CPRD Gold and Aurum from 2010 to 2022 with linked information on hospitalizations and mortality.
To address these gaps, our study primarily aims to evaluate the comparative effectiveness and safety profiles among different direct oral anticoagulants (DOACs), and further assess varying anticoagulant dosages by individual DOAC. We will further stratify our analyses based on therapeutic indications (i.e. atrial fibrillation and venous thromboembolism). Longitudinal clinical data will be employed to estimate propensity scores within each cohort using logistic regression. We will utilize Cox proportional hazards regression to compare outcomes related to ischemic stroke and major bleeding in propensity score-matched cohorts. Additionally, subgroup analyses will be conducted for specific populations at higher risk of adverse effects, such as those with chronic kidney disease (CKD) or a history of intracranial bleeding.
Importantly, our study takes a broad approach by examining a spectrum of chronic diseases and outcomes, aiming to provide a comprehensive understanding of choice of DOAC, dosing and its implications on outcomes. This approach will enhance the clinical applicability of our research findings.
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Developing Algorithms to Predict Individual Patient Response to Anticoagulant, Antidiabetic and Antidepressant Drug Treatment — Samy Suissa ...
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Developing Algorithms to Predict Individual Patient Response to Anticoagulant, Antidiabetic and Antidepressant Drug Treatment
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-08
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Robyn Tamblyn - Corresponding Applicant - McGill University
Bettina Habib - Collaborator - McGill University
David Buckeridge - Collaborator - McGill University
Emily McDonald - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Nadyne Girard - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Teresa Moraga - Collaborator - McGill UniversityOutcomes:
Anticoagulant drug cohort (for atrial fibrillation): ischemic stroke, bleeding, systemic embolism, myocardial infarction (MI), heart failure, death, hospital admission, side effects of anticoagulant drugs
Anticoagulant drug cohort (for VTE): recurrent venous thromboembolism (VTE), bleeding, post-thrombotic syndrome, chronic thromboembolic pulmonary hypertension, chronic thromboembolic pulmonary disease, death, hospital admission, side effects of anticoagulant drugs
Antidiabetic drug cohort: glycaemic control, stroke, MI, microvascular and cardiovascular complications of diabetes, composite of MI, stroke and cardiovascular death, hospital admission, death, side effects of antidiabetic drugs
Antidepressant medication cohort: antidepressant treatment discontinuation or treatment change, suicide attempts, side effects of antidepressant drugs.Description: Lay Summary
Prescription drugs are important for preventing and treating health problems, but are not as beneficial as they could be. This is because there is often little information on a drugâs safety and effectiveness after it is approved for sale. It is also difficult to personalize treatment to a patientâs particular situation and guide physician prescribing. Personalizing treatment is important because patients with the same conditions do not always benefit equally from the same medications. Patient experiences differ based on many factors, including demographic, lifestyle, and clinical factors. A patient of a certain age, sex, ethnicity, and medical history may benefit from a medication that causes harm to a patient with different traits. In this study, we aim to develop predictive algorithms to personalize drug treatment. We have selected three medication classes with typically unexplained differences between patients in their experiences with the medication. These include blood thinning medications for patients with atrial fibrillation (a heart rhythm disorder) and venous thromboembolism (blood clots), blood sugar-lowering medications for patients with type 2 diabetes (condition characterized by high blood sugar), and antidepressant medications for patients with depression, anxiety, and insomnia. We will develop predictive algorithms that predict, for a single patient, the risks and benefits of different medications within each therapeutic class. Such algorithms have the potential to improve experiences and health outcomes for thousands of patients who take these drugs in the UK. This, in turn, could reduce health system costs due to reduced hospital and emergency department use by these patients.
Technical SummaryDespite the considerable benefits of modern drug therapy, the full potential of medications to improve population health is currently not realized due to limited capacity to assess real-world safety and effectiveness, personalize treatment, and influence use in practice. The main objective of this study is to develop and validate algorithms that predict individual treatment response for three therapeutic drug classes and treatment indications: anticoagulant drugs for atrial fibrillation and venous thromboembolism (VTE), antidiabetic drugs for type 2 diabetes, and antidepressant drugs for depression, anxiety, and insomnia. We will create each cohort by selecting individuals with a diagnosis for the condition of interest in CPRD AURUM and HES APC data, and subsequently prescribed a drug of interest between 2018 and 2022, as observed in CPRD AURUM data. Individuals will be followed from the date of their first prescription of a study drug until the first occurrence of the outcome being modelled, their departure from the cohort, or the end of 2022, whichever occurs first. Exposures will be modelled as time-varying use and time-varying dose of anticoagulant, antidiabetic, and antidepressant medications. For each drug class and condition of interest, we have identified the top 5-10 outcomes that patients most value and prioritize. For every outcome being modelled, we have also identified time-fixed and time-varying predictors, including a range of patient demographic, lifestyle, and clinical characteristics and history. Both standard statistical approaches and machine learning will be used to generate algorithms that predict the occurrence of these outcomes. We will use measures such as the c-statistic, ROC curve, and the Brier score to measure model performance. The best-performing models will then be validated externally in comparable cohorts assembled from partner institutions. Validated algorithms will be implemented in the real-word and reinforcement learning methods will then be employed to improve algorithm accuracy.
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Optimising Structured Medication Reviews for Older People with Severe Frailty and Care Home Residents to Reduce Over-prescribing and Associated Inequalities — Andrew Clegg ...
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Optimising Structured Medication Reviews for Older People with Severe Frailty and Care Home Residents to Reduce Over-prescribing and Associated Inequalities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-26
Organisations:
Andrew Clegg - Chief Investigator - University of Leeds
Kate Best - Corresponding Applicant - University of Leeds
David Alldred - Collaborator - University of Leeds
Lauren Walker - Collaborator - University of Liverpool
Munir Pirmohamed - Collaborator - University of Liverpool
Oliver Todd - Collaborator - University of LeedsOutcomes:
Adverse outcomes related to high-risk medications (excluding steroids) (ANALYSIS 1a)
⢠Hospitalisation with delirium (ICD 10 codes)
⢠Hospitalisation for a fall or fragility fracture (ICD 10 codes)Steroid-related adverse outcomes (ANALYSIS 1b)
⢠New diagnosis of Diabetes (Systematised Nomenclature of Medicine Clinical Terms (SNOMED-CT) codes).
⢠Hospital admission for a fragility fracture (ICD 10 codes)
⢠Hospital admissions for infection or mortality with infection listed as cause of death (SNOMED CT code list tbc )SMR offer/uptake (ANALYSIS 2):
We will investigate inequities at 3 key stages of the SMR process, using the following process measures, all of which are included in the Primary Care Networks (PCN) SMR contract specification using standardised SNOMED-CT coding.
⢠Invitation of patients for SMR (using SNOMED CT code 1363201000000103, no READ code).
⢠Decline of SMR by patients (using SNOMED CT code 1363191000000100, READ code 8I3V.00).
⢠SMR receipt (using SNOMED CT code 1239511000000100, READ code 8B3S200).Medication-related outcomes (ANALYSIS 3a):
⢠Number of medications (British National Formulary (BNF) subchapters).
⢠Number of medications of high-risk drug groups: 1) opioids, 2) gabapentinoid, 3) benzodiazepines, 4) z-drugs, 5) steroid medications). We will refine our operational definition of high-risk drug groups to be considered for inclusion through an initial workshop with stakeholders at the start of the project.
⢠Anticholinergic Medication Index (ACMI) score, developed and validated by our co-apps Best and West in a Health Data Research UK (HDRUK) funded project led by Chief investigator Clegg.Health and social care outcomes (ANALYSIS 3b)
⢠Hospital admission (all-cause; hospitalisation with delirium; hospitalisation with falls).
⢠Number of primary care consultations.
⢠Time at home (number of days living at home, taking into account hospitalisation/length of stay and mortality).
⢠Care home admission (determined using 49 clinical codes, used in previous CPRD study (28)).
⢠Mortality, using linked ONS data.Description: Lay Summary
Background: To try and reduce the prescribing of unnecessary medications, the NHS in England has introduced routine medication reviews for older people with severe frailty, care home residents and adults across all age groups prescribed high-risk medications. However, there are concerns that some people may not be getting these reviews, for example people from ethnic minority groups or people living in deprived areas. This can cause unfair differences in health outcomes-termed âhealth inequalitiesâ.
Aim: To improve the access to medication reviews to ensure they meet the diverse need of people with severe frailty living in the community, care home residents and adults prescribed high-risk medications across different ethnic groups and in more deprived areas of England.
Methods: We will use anonymous data from CPRD. We will analyse the data to predict which people might be at risk of medication-related side effects. We will also find out if there are differences in how medication reviews are being provided for older people with severe frailty, care home residents and people prescribed high-risk medications (e.g. opioid medications, sedatives, long-term steroids). We will also find out if there are differences in the number of medicines that have been stopped for different ethnic groups and for people living in deprived areas.
Technical SummaryFor patients prescribed multiple medications, problematic polypharmacy is where the potential for harm outweighs benefits from the medicines, and/or the implications of the medication regimen are not fully understood by patients. Structured Medication Reviews (SMRs) are evidence-based, comprehensive reviews of patientsâ medications, which are aimed at decreasing over-prescribing and ultimately reducing adverse drug-related outcomes. From October 2021, all Primary Care Networks (PCNs- groups of typically 5-8 general practices working closely together in priority areas) in England have been required to proactively target patients who would benefit most from an SMR, with five âhigh riskâ groups identified. In this study, we will focus on three of the high-risk groups:
⢠Those prescribed a high-risk medication: 1) opioids, 2) gabapentinoids, 3) benzodiazepines, 4) z-drugs, 5) steroid medications.
⢠Patients with severe frailty, as defined by the electronic Frailty Index 2 (eFI2).
⢠Care home residents, determined using 49 clinical codes, used in a previous CPRD study.The aim of this study is to address problematic over-prescribing among the three high-risk groups of patients by a) identifying patients at risk of medication-related adverse outcomes; b) examining whether offer and uptake of Structured Medication Reviews (SMRs) varies according to intersectional characteristics (age, gender, ethnicity, socioeconomic status); and c) investigating whether drug-burden and medication-related adverse outcomes decreased following the implementation of the SMR PCN contract.
Clinical prediction models that predict the risk of drug-related adverse outcomes will be developed using Cox regression. The odds of SMR invitation/decline/receipt following PCN SMR contract implementation (1/10/21 onwards) will be modelled according to intersectional characteristics using multilevel logistic regression. Interrupted Time Series (ITS) models will be performed to examine whether there were changes in the level and slope of all medication-related and health and social care outcomes in England in the 2 years following the PCN SMR contract implementation.
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Nonsteroidal anti-inflammatory drugs use in gout and the risk of skin ulcer — Samy Suissa ...
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Nonsteroidal anti-inflammatory drugs use in gout and the risk of skin ulcer
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-24
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Charles Khouri - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Skin ulcer, either diabetic, venous or pressure ulcer.
Description: Lay Summary
Skin ulcers are a breakdown in the skin which affect millions of people in United Kingdom. Up to 50% of skin ulcers are not fully healed at 6 months despite an optimal treatment, contributing significantly to pain and social discomfort, and can lead to major complications. People of older age and female sex, and those with diabetes, hypertension, malnutrition and who smoke are at higher risk of getting skin ulcers. It is unknown whether medications can also cause these skin ulcers. One potential medication that could cause this is the class of ânonsteroidal anti-inflammatory drugsâ (NSAIDs), used to treat pain and inflammation in numerous diseases. We will study one such disease, gout, since NSAIDs are commonly used to treat gout flare-ups and are at higher risk of skin ulcers because they share the same characteristics. This study will use the Clinical Practice Research Datalink to investigate whether the use of NSAIDs is associated with the onset of skin ulcers in patients treated for gout. This study will therefore be able to assess this potential risk of skin ulcer associated with NSAIDs use in a high risk patient population. If confirmed, this study will help inform clinical practice guidelines and personalize gout flare treatment for patients in England and Wales.
Technical SummaryThe lifetime incidence of chronic skin ulcer is estimated at 1â2% of the population. Vascular disease, diabetes and aging are the main risk factors causing venous leg ulcers, diabetic foot ulcers and pressure ulcers, respectively. An analysis of the WHO pharmacovigilance database conducted by our team highlighted a significant association between skin ulcers and cox-2 inhibitors.
Cox-2-inhibitors and traditional NSAIDs are used in numerous diseases with heterogeneous doses and durations making it difficult to find comparator groups with similar baseline risk factors of skin ulcer. Thus, to increase the comparability of groups between exposed and non-exposed patients, we will restrict the cohort to patients diagnosed with gout.
The primary objective of this study is to assess the association between NSAIDs use and skin ulcers, compared to non-use, in a cohort of patients 30 years of age or more between April 1997 and March 2021 with a diagnosis of gout.
A prevalent new-user cohort design will be employed, by which patients with gout initiating NSAIDs added to a baseline treatment with allopurinol will be matched to patients taking allopurinol alone. All patients will be followed until skin ulcer, death from any cause, initiation of other gout therapy (colchicine, corticosteroids or NSAIDs for non-users), end of registration with the general practice, end of the study period (last linkage coverage in HES APC data), or one year after cohort entry whichever occurs first.
We will quantify the absolute risk of skin ulcers in the exposed and unexposed groups in terms of events per 10000 person- years with accompanying 95% CI. The hazard ratio (HR) and corresponding 95% confidence interval (CI) of the outcomes with NSAIDs use versus non-use will also be estimated using a Cox proportional hazards regression model.
This study will help inform clinical practice guidelines and personalize gout flare treatment.
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Effectiveness of Human Papillomavirus Vaccines (HPV) to prevent cervical, anal and oropharyngeal cancer: a target trial emulation analysis — Albert Prats Uribe ...
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Effectiveness of Human Papillomavirus Vaccines (HPV) to prevent cervical, anal and oropharyngeal cancer: a target trial emulation analysis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-18
Organisations:
Albert Prats Uribe - Chief Investigator - University of Oxford
Nicola Barclay - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Marta Alcalde-Herraiz - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
Invasive Cervical Cancer; Cervical intraepithelial neoplasia (CIN2 and CIN3); Conization of the cervix or cold knife cone; Anal Cancer; Oropharyngeal Cancer
Description: Lay Summary
Human Papillomavirus (HPV) vaccinations are designed to protect against infections caused by the human papillomavirus, a group of viruses that can infect the genital area, as well as the mouth and throat. HPV is the most common sexually transmitted infection globally. While most HPV infections resolve on their own, certain strains can persist and lead to various cancers, with cervical cancer being the most well-known.
In addition to cervical cancer, HPV is linked to other cancers, including anal and oropharyngeal (mouth and throat) cancers. The virus is responsible for a lot of these cancers, and vaccination provides a preventive measure to reduce the risk of HPV-related cancers.
The availability and widespread use of HPV vaccinations contribute to significant public health benefits by preventing infections and reducing the incidence of HPV-related cancers. Vaccination programmes are typically recommended for adolescents before they become sexually active, providing them with protection before potential exposure to the virus.
The aim of this study is to use health record data of vaccinated and unvaccinated individuals to see whether HPV vaccination reduces risk for cervical cancer in women, and anal and mouth/throat cancers in women and men. The study also aims to see whether a different number of vaccine doses (1, 2 or 3) has an effect on reducing cancer risk. This is important because if one dose provides enough protection against cancer, then vaccination programmes that currently provide three doses could be altered to reduce health service costs, whilst still providing protection against severe disease.
Technical SummaryHPV vaccination programmes reduce not only HPV infection but also the incidence of cervical cancer. However, uncertainty remains on the real-world effectiveness of different brands, dose schedules, and their potential effect against other HPV-caused cancers.
This study aims to generate evidence from real-world data using CPRD GOLD database on the effectiveness of different doses (one, two, three) of HPV vaccination in preventing severe disease outcomes, including invasive cervical cancer, and other HPV-related cancers, for the different licensed HPV vaccines in the UK.
This will be a target trial emulation, new user matched cohort study as follows:
Eligibility criteria: Participants >9yo any date after the launch of the vaccination programme (2008)
Treatment strategies: Unvaccinated, vaccinated with 1 dose (or â¥1), vaccinated with 2 doses (or â¥2), and vaccinated with 3 doses (or â¥3).
Assignment procedures: For unvaccinated/vaccinated the unvaccinated, vaccinated are assigned as seen in the data at 15 years old. Unvaccinated will be assigned as not being vaccinated at 15 years old, and censored when (and if) they get vaccinated later on. Two or three doses will be assigned at the same moment.
Follow-up: Follow-up time starts from index date, defined as date a participant turns 15 years old. Followed until next vaccine dose or outcome event, end of available follow-up, or death of any individual of the matched pair, whichever comes first.
Statistical methods: Incidence rates and incidence rate ratios (IRR) will be calculated for outcomes at 5, 10, 15 years (if enough follow-up is available). Cox proportional hazard models will be used to calculate hazard ratios (HR) for time-to-event analyses. Negative control outcomes and empirical calibration for IRR/HR will be used to minimise residual confounding.
Analyses will be stratified by age groups of interest (age at vaccination <16, 17-19, >20 years) and sex (where applicable; i.e. objective 4).
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Modelling kidney disease progression, cardiovascular outcomes and related healthcare costs in chronic kidney disease and assessing the use of risk modifying therapy in chronic kidney disease, diabetes and heart failure — Borislava MIHAYLOVA ...
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Modelling kidney disease progression, cardiovascular outcomes and related healthcare costs in chronic kidney disease and assessing the use of risk modifying therapy in chronic kidney disease, diabetes and heart failure
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-23
Organisations:
Borislava MIHAYLOVA - Chief Investigator - University of Oxford
Claire Williams - Corresponding Applicant - University of Oxford
Junwen Zhou - Collaborator - Nuffield Department of Population Health
Kaitlin Mayne - Collaborator - Nuffield Department of Population Health
Natalie Staplin - Collaborator - University of Oxford
Richard Haynes - Collaborator - University of Oxford
William Herrington - Collaborator - University of OxfordOutcomes:
Note to reviewer: For aim 1, use of SGLT2i is a covariate of interest alongside other pre-specified covariates associated with disease risks; it is not focus of the investigation. For aim 2, SGLT2i is an exposure. We have now distinguished between primary outcomes and key secondary outcomes.
A. Outcomes to be Measured
Aim 1Primary outcomes (i.e. the longitudinal and time-to-event outcomes that will be modelled)
Longitudinal outcome:
⢠Estimated glomerular filtration rate (eGFR), including derivation from serum creatinine using the CKD-EPI 2009 equation(1) and, as a sensitivity analysis, the CKD-EPI 2021 equation without race(2).Time to event outcomes:
⢠Myocardial infarction
⢠Stroke
⢠Transient ischaemic attack
⢠Hospitalisation for heart failure
⢠Cardiovascular death
⢠Non-cardiovascular death (includes death due to kidney failure, infection and cancer).Key secondary outcomes:
Costs outcomes:
Primary care costs
⢠GP consultation
⢠Diagnostic and monitoring tests
⢠Prescription medicationHospital care costs
⢠Inpatient admission
⢠Outpatient visits
⢠Accident and emergency visitsPotential adverse events from treatments:
SGLT2i:
⢠Ketoacidosis (in patients with diabetes)
⢠Lower limb amputation
⢠Urinary tract infections
⢠Mycotic genital infections
⢠Severe hypoglycaemia
⢠Bone fracture
⢠Fournierâs gangreneRenin-angiotensin-aldosterone (RAAS) pathway inhibitors (ACE inhibitors, Angiotensin-II receptor blockers and mineralocorticoid receptor antagonists):
⢠Hypotension
⢠Hyperkalaemia (or serum potassium concentration >5.5 mmol/L)GLP-1 receptor antagonists
⢠Gastrointestinal disorder (nausea, vomiting, diarrhoea)
⢠Severe hypoglycaemia
⢠Pancreatitis
⢠Malignancy and specifically pancreatic carcinoma, medullary thyroid carcinomaStatin-based therapy
⢠Myopathy and rhabdomyolysis
⢠New onset diabetesâAim 2
Primary outcome
⢠proportion of the study population with an indication for the primary exposure SGLT2 inhibition (CKD, type 2 diabetes or heart failure) who are prescribed SGLT2 inhibitorSecondary outcomes
⢠proportion of the study population (CKD, type 2 diabetes or heart failure) with an indication for a secondary exposure who are prescribed the respective secondary exposure. Secondary exposures are renin-angiotensin-aldosterone pathway inhibitors (ACE inhibitors, Angiotensin-II receptor blockers and mineralocorticoid receptor antagonists [steroidal and non-steroidal]), GLP-1 receptor antagonists, statin-based therapy and prescriptions for treatment of anaemia in CKD.Description: Lay Summary
1) Health economics model aim: People with kidney disease have more rapid decline in kidney function which means that they may require dialysis or a kidney transplant. They are also more likely than people without kidney disease to develop cardiovascular diseases such as heart disease and stroke and die earlier. Previous research has shown that statins to lower cholesterol and blood pressure medications can help people with kidney disease reduce their chances of developing cardiovascular disease. Recently new drugs have been found that also slow the decline in kidney function. Our research will focus on people with kidney disease, assess their disease progression and other complications, and evaluate these new drugs over longer term, while also looking at the impact of slowing kidney function decline on the chances of developing cardiovascular disease and other poor health. We will determine the groups of patients who are likely to benefit most from these new drugs to help better target limited NHS resources.
(2) Use of risk modifying treatment aim: Several treatments for kidney and cardiovascular disease have been found to work in clinical trials. Effective implementation of such treatment is crucial to ensure disease risks are safely reduced in the UK. We know that some patient groups are less likely to receive such treatments in a timely manner and therefore we wish to better understand the patterns of prescription and use over time in different types of people at risk. This will help highlight where there is underuse or inequitable use.
Technical SummaryAim 1: Health economic model
Background: SGLT2 inhibitors (SGLT2is) reduce heart failure admissions, mortality and kidney disease progression. However, there is no individual patient data-derived CKD model to evaluate the long-term effects of such treatments in different categories of patients.
Methods: Using a pre-specified CPRD CKD cohort, a long-term CKD decision-analytic policy model will be developed and validated as follows: 1) estimation of multivariable prediction models of time-to-event outcomes (myocardial infarction, stroke, heart failure hospitalisation and death) and longitudinal outcomes (estimated glomerular filtration rate); 2) estimation of multivariable generalised linear models for annual healthcare costs of CKD patients; 3) models from 1) and 2), together with data on quality of life in CKD informed from EMPA-KIDNEY trial data and/or published studies, will be integrated into a CKD model; 4) CKD cohort participantsâ characteristics and effects of SGLTi informed from randomised trials will be used to assess the cost-effectiveness of SGLTi in categories of CKD patients. All aforementioned models will adjust simultaneously for a pre-specified set of covariates with no single covariate being the focus of interest.
Aim 2: Assessing UK prescription trends of proven risk modifying therapies in patients with an indication
Study population: Adult patients with CKD, type 2 diabetes and/or heart failure
Primary exposure: prescribed SGLT2i (yes/no)
Secondary exposures: prescribed renin-angiotensin-aldosterone pathway inhibitors, GLP-1 receptor antagonists, statin-based therapy and prescriptions for treatment of anaemia in CKD
Outcome: Proportion of indicated population who are prescribed SGLT2 inhibitor and,
separately, secondary exposuresStudy design: Cohort study
Methods: Descriptive analyses will summarise patterns of use over time of the
aforementioned exposures by indication for use (using guidelines or trial-driven indications). Logistic regressions will then identify factors associated with underuse (including age, sex, level of deprivation, ethnicity, comorbidity [including CKD, heart failure and diabetes], and markers of kidney disease risk (eGFR/albuminuria/proteinuria).
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Calculating the impact of optimising preconception health among women with mental illness — Holly Hope ...
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Calculating the impact of optimising preconception health among women with mental illness
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-08
Organisations:
Holly Hope - Chief Investigator - University of Manchester
Hend Gabr - Corresponding Applicant - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Kathryn Abel - Collaborator - University of Manchester
Matthias Pierce - Collaborator - University of Manchester
Rachel Elliott - Collaborator - University of ManchesterOutcomes:
Outcomes are grouped into those experienced by 1) women 2) offspring and 3) costs.
1) Women:
a) Metabolic disease
Diabetes Type II
Metabolic syndrome
Diabetes I
Gestational diabetes
b) Reproductive health
Ovarian cancer
Breast cancer
Cervical cancer
Vulval cancer
Other reproductive cancers
Primary infertility
Secondary infertility
Polycystic ovarian syndrome
c) Respiratory
Asthma
Chronic Obstructive Pulmonary disease (COPD)
d) Cardiovascular disease
Hypertension
Gestational Hypertension
Pre-eclampsia/eclampsia
High Cholesterol
Ischaemic heart disease
Pulmonary heart disease
Cerebrovascular heart disease
Other heart disease
e) Psychiatric
Depression
Anxiety
Psychosis (affective and non-affective)
PTSD
Any other hospital admission for a mental or behavioural disorder
2) Offspring:
f) Pre-term birth
g) Small for gestational age
h) Any intra-natal intervention (forceps, ventouse etc.)
i) Emergency caesarean
j) Resuscitation at birth
3) Cost:
i) Cost of preconception health intervention
j) Cost of admissions for outcomes (a through j)Outcomes for women will be derived from CPRD and HES databases, offspring outcomes will be derived primarily from HES maternity and supplemented with Pregnancy Register data.
Costs of interventions will be derived from the literature and supplemented with estimates from universal tariffs.
Costs of admissions will be derived from HES health resource codes linked to hospital admissions procedural codes that are costed within NHS tariffs.Description: Lay Summary
What we know now
One-in-six women experience mental illness before pregnancy. Unfortunately, women with mental illness are more likely to smoke and be overweight or obese, they may also delay antenatal booking and folate use, all of which can harm parent and child.What is our aim?
Therefore, our aim is to provide information on what would happen if we were to provide support for women with mental illness who wish to get pregnant and what the support should look like.What we shall do
We shall create a cohort of pregnant women, using information from their GP and hospital records. We shall test if the health of all women and children can be improved if the health of women with mental illness is improved. For example, we shall show what would happen if fewer women aged 14 to 45 years with mental health problems smoked before or during pregnancy.We shall use estimates of effectiveness and costs of intervention from previous research and apply them to our cohort of women to see which type of support has the greatest effect and offers the best value for money.
What will this mean?
Technical Summary
There are different ways to support women in pregnancy. These include counselling, âEvery contact countsâ (giving advice during everyday consultations), or peer-to-peer support. Some are better and/or more expensive than others.
Describing the costs and benefits of different types of support will help integrated care boards, and policy makers to decide what clinical services to fund.For women with mental illness, smoking and being overweight are common reversible risk associated with poor reproductive and obstetric outcomes e.g. prematurity, intranatal intervention such as forceps delivery and emergency caesarean section. To reduce health inequalities experienced by WMI, several tailored approaches exist, such as âEvery contact countsâ, or peer-to-peer support. However, most women with mental health problems only receive generic preconception and pregnancy health advice within primary care settings. The aim of this protocol is threefold.
First: We shall conduct an umbrella review to evaluate the effectiveness of smoking cessation, weight loss folate use and late booking in WMI. The results from the umbrella review will be incorporated with the result of the modelling part to provide information on what would happen if we were to provide heath support for WMI who wish to get pregnant, what the support should look like and who should receive it.
Second: Using a cohort of all women (14-45) registered 2014-2018 at a CPRD-Aurum participating practice and code lists and algorithms already developed, we shall;
- determine the number of women reporting to primary care with mental health problems (depression, anxiety, psychosis, eating disorders and personality disorders).
- determine which women are most likely to smoke, be overweight or obese in pregnancy and delay taking folate and making their first antenatal appointment
-investigate reversible risks (e.g. smoking) by strata of mental illness, English region, ethnicity, age-group and IMD quintile
-model the predicted outcomes if risks were reversed.
-Conduct a sensitivity analysis to test the reliability of population effects as the primary care data are not geographically representative [1].Third:
Using costings from extant economic evaluations, NHS and other service tariffs we shall estimate the direct and indirect medical costs per person of delivering different types of interventions to compare their cost effectiveness.
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The effect of diabetes medications on chronic lung disease: a population-cohort study — Chloe Bloom ...
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The effect of diabetes medications on chronic lung disease: a population-cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-26
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Bohee Lee - Collaborator - Imperial College London
Davina Tijani - Collaborator - Imperial College LondonOutcomes:
Treatment of acute exacerbations of (i) ACOS, (ii) COPD and (iii) IPF
Description: Lay Summary
Diabetes is a chronic condition that causes high glucose levels. Glucose levels can be maintained at a healthy level using medication, or some people can maintain good glucose levels just by changing their diet. Many people with long term lung conditions have diabetes. It may be that some drugs to treat diabetes can also help people with long term lung conditions. This study will use real-world data to see if people with lung conditions that are taking these medications for their diabetes are less likely to have acute episodes of worsening lung symptoms, such as cough and breathlessness. The lung conditions that we will look at include (a) a condition called 'chronic obstructive pulmonary disease', which is also known as COPD; this lung condition is usually caused by smoking cigarettes and typically causes people to be short of breath and cough (b) a condition that is called 'asthma and COPD overlap' and is when people have both asthma (a lung condition that causes breathlessness and wheeze) and COPD; (c) lung fibrosis which is when there is scarring in the lungs and this also causes breathlessness. If we find these medications help this could be a new treatment for lung conditions and could also mean that some patients are advised to take diabetes medications as soon as they find out they have diabetes, not wait and try to reduce the glucose by diet first.
Technical SummaryThe aim of this study is to determine the effectiveness of diabetes medications to reduce acute exacerbations of chronic respiratory disease. To do this, we will draw a cohort of adults with diabetes and chronic lung disease (CLD) including COPD, ACOS or idiopathic pulmonary fibrosis between 2004 and 2021. The exposure will be diabetes medication. The outcome will be respiratory exacerbations, defined as either managed using oral corticosteroids from their GP, an A&E or hospital admission (HES), or death (ONS). We will assess the real-world effectiveness of each of the diabetes medications to reduce respiratory exacerbations in patients with CLD and diabetes. To estimate the association between metformin and respiratory exacerbations we will use three methods (a) self-controlled case series design and conditional Possion regression, this methodology implicitly removes time-invariant confounding, e.g. socioeconomic status, genetics, metabolic dysfunction and is well suited for pharmacoepidemiology studies; (b) propensity score, cohort, methodology where exposed patients will be those with incident use of the diabetes drug; (c) nested case control, where cases will have the exacerbation and controls will be matched 1:4 by gender, age and GP practice. We will also determine if associations between diabetes medication and respiratory exacerbations are modified by gender, body mass index, weight loss, or lung disease phenotype. We will also compare the effect between the different CLD which may help elucidate mechanism as the diseases differ by pathology (COPD and ACOS are more inflammatory and affect the airways whereas IPF is more fibrotic and affects the lung parenchyma). The public health benefit is to provide additional and robust evidence regarding the use of these therapeutics in the management of chronic lung disease.
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The epidemiology of sarcoidosis in the United Kingdon — Katie Bechman ...
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The epidemiology of sarcoidosis in the United Kingdon
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-09
Organisations:
Katie Bechman - Chief Investigator - King's College London (KCL)
James Galloway - Corresponding Applicant - King's College London (KCL)
Mark Russell - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes:
Primary outcome; Incidence and prevalence rates of sarcoidosis
Key secondary outcomes: 1) all-cause 1-year mortality; 2) all cause and sarcoidosis-specific hospitalisation rate; 3) incidence of disease-specific damage; 4) incidence and time to prescription of immunomodulating therapy.
Description: Lay Summary
Background
Sarcoidosis is a rare inflammatory condition where clusters of cells called granulomas develop at different sites of the body. The disease course is unpredictable and can range from a self-limiting to severe organ involvement and death.Why study sarcoidosis
Despite the severity of sarcoidosis, itâs astonishing how little we know about condition in the UK. We do not know the total number of people with the disease or how many new diagnoses are made each year. Studies from other countries demonstrate difference by region and ethnicity, but we are unaware if the same patterns are seen in the UK. Death from sarcoidosis is largely attributable to lung and heart complications, and older studies suggest an that the mortality rate is increasing. We do not know if this trend has plateaued or continues along a similar trajectory.Objective
Using CPRD with linked hospital and mortality data, our objective is to calculate the number of patients with sarcoidosis (prevalence) and the number of new diagnoses each year (incidence) in the United Kingdom. We will describe this data by ethnicity and across regions. We will examine the severity of disease by calculating the rates of hospitalisation, organ damage and death, and examining factors that predict these outcomes.Potential impact
Technical Summary
Bridging important knowledge gaps will ultimately improve outcomes for affected individuals. Clinicians will be armed with insight into the condition, enhancing accurate diagnosis and improving navigation of treatment options. Understanding regional variations will improve NHS resource allocation and access to vital clinical trials.Technical Summary (Max. 300 words)
Background:
Sarcoidosis is a rare systemic inflammatory disorder of unknown aetiology, which can result in organ damage and premature death. Despite its clinical significance, there is a scarcity of UK data on disease incidence, prevalence, and regional variation. Studies conducted decades ago indicated a rising mortality rate. There are no recent data on this, and the status of this trajectory is uncertain.Objective:
To determine the incidence, prevalence, morbidity, and mortality rates of sarcoidosis in the United Kingdom.Methods:
The study population of interest is patients with primary or secondary care diagnoses of sarcoidosis between 2003 and 2023. Incidence and prevalence rates will be calculated by year, and stratified by age group, sex, ethnicity, and region. The mortality rates for sarcoidosis with be calculated using linkage with UK Office for National Statistics death register, and age-adjusted Standardised Mortality Ratios will be estimated by indirect standardisation according to UK mortality data. Through linkage with the NHS Digital Hospital Episode Statistics datasets, rates of all-cause hospitalisation, and hospitalisation with sarcoidosis as a primary diagnosis, will be calculated by person years. Rate ratios of hospitalisation and death will be estimated using a matched non-sarcoidosis comparator cohort, and regression models will be used to examine risk factors for severe disease outcomes. Disease severity will be analysed by calculating rates of organ-specific damage and examining the use of immunomodulating therapy.Public health benefits:
This will be the first study to describe the epidemiology of sarcoidosis in the United Kingdom. Establishing the burden of disease and characterising high-risk populations will enable the development of targeted interventions for facilitating early diagnosis. Understanding the morbidity and mortality associated with sarcoidosis is crucial for refining healthcare policies, optimizing resource allocation and improving patient outcomes.
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Development of prediction models for clinically relevant complications in primary care superficial venous thrombosis patients — Patrick Souverein ...
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Development of prediction models for clinically relevant complications in primary care superficial venous thrombosis patients
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-08
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Florien van Royen - Collaborator - University Medical Centre Utrecht
Frans Rutten - Collaborator - University Medical Centre Utrecht
Geert-Jan Geersing - Collaborator - University Medical Centre Utrecht
Karel Moons - Collaborator - University Medical Centre Utrecht
Maarten van Smeden - Collaborator - University Medical Centre Utrecht
Sander van Doorn - Collaborator - University Medical Centre UtrechtOutcomes:
This study focusses on complicated disease trajectories of SVT in primary care, including:
- Prolonged symptoms within 14 days after SVT diagnosis: prolonged painful symptoms and/or extension of the SVT clot to the saphenofemoral junction (SFJ)
- Clot progression to DVT and/or PE within 45 days
- Recurrent SVT within 12 monthsDescription: Lay Summary
Background:
In patients with a superficial venous thrombosis (SVT) a blood clot is present in a superficial vein. Patients with this condition experience pain, swelling and redness of the affected vein. Often, SVT only leads to a short period of inconvenience as it resolves naturally with the application of cold bandages and pain killers. The condition is often managed in primary care. In a subset of patients however, the SVT blood clot can grow and spread loose towards the deeper venous system, leading to deep vein thrombosis (DVT) or even embolize leading to pulmonary embolism (PE). Other patients may experience prolonged painful symptoms or recurrent SVT. It is important to treat these subgroups of SVT patients in time as notably DVT and PE can lead to serious complications, including death by PE. Unfortunately, doctors currently do not know precisely which patients are at high risk of developing these complications.Purpose of the study:
The aim of this study is to predict which primary care patients with SVT are at risk of developing deep venous thrombosis and/or pulmonary embolism, prolonged painful symptoms or recurrent SVT.Potential importance of the findings:
Technical Summary
A simple tool will be developed for the primary care physician and their patients to estimate the risk of complications in primary care SVT patients. This will improve tailored treatment decision making and will better prevent severe SVT complications.Aim and objectives:
Superficial venous thrombosis (SVT) is considered a benign thrombotic condition in most patients. However, it also can cause serious complications, such as clot progression to deep venous thrombosis (DVT) and pulmonary embolism (PE). This study aims to predict the risk of serious complications for SVT patients presenting in primary care settings.Primary exposures:
Adult patients diagnosed with SVT presenting in primary care will be included for this study. Selection of SVT cases will be based on a combination of Read and/or Snowmed coding.Outcomes:
Three prognostic prediction models will be developed and externally validated for relevant SVT clinical outcomes: (i) for prolonged (painful) symptoms within 14 days since SVT diagnosis, (ii) for clot progression to DVT or PE within 45 days, and (iii) for clot recurrence within 12 months.Study design:
This is a prognostic cohort study using routinely collected primary care data.Methods:
Data will be used from four primary care routine healthcare registries from both the Netherlands and the UK; the UK CPRD Aurum database will be used for the development of the prediction models and the remaining three will be used as external validation cohorts. Predictors considered are sex, age, Body Mass Index, clinical SVT characteristics, and co-morbidities including: (history of any) cardiovascular disease, diabetes, autoimmune disease, malignancy, thrombophilia, pregnancy or puerperium and presence of varicose veins. Linking to Hospital Episode Statistics (HES),and Pregnancy Register, will be used to collect relevant information on outcomes and pregnancy. The prediction models will be developed using multivariable logistic regression analysis techniques for model i and ii and for model iii a Cox proportional hazards model will be used. They will be validated by internal-external cross-validation as well as external validation.
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Epidemiology of Hypophosphatasia (HPP) in the UK: A Retrospective Cohort Study using Clinical Practice Research Data Link (CPRD) — Shona Fang ...
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Epidemiology of Hypophosphatasia (HPP) in the UK: A Retrospective Cohort Study using Clinical Practice Research Data Link (CPRD)
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-12
Organisations:
Shona Fang - Chief Investigator - Alexion Pharmaceuticals, Inc ( USA )
Daniel Carey - Corresponding Applicant - Alexion Pharma International Operations Limited (Ireland)
Feifei Yang - Collaborator - Alexion Pharmaceuticals, Inc ( USA )
Luke McGuinness - Collaborator - Alexion Pharma International Operations Limited (Ireland)Outcomes:
Prevalence:
Prevalence proportions will be calculated with respect to the CPRD reference population, expressed per 100,000 of population. Prevalence will be calculated and reported as annual period prevalence per year of the prevalence period (2018-2022), and as 5-year period prevalence (i.e., across the entire period, 2018-2022). Prevalence will be reported for the full HPP patient population, and stratified by age (paediatric/adult) and sex.Comorbidities:
Comorbidities will be summarized as conditions present in the prevalence period (2018-2022) in those patients captured in the prevalence period cohort (2018-2022); in addition, for prevalent patients in the year 2022, comorbidities will be reported as conditions occurring within that year. Comorbidities will be reported separately for the prevalence period and the year 2022 as: i) the top 10 most frequent comorbidities across patients (based on unique patient counts), stratified by age (paediatric/adult); ii) the frequencies of HPP-specific signs and symptoms, stratified by age (paediatric/adult); iii) the frequencies of mood and sleep disorders, stratified by age (paediatric/adult).Mortality:
Mortality rates associated with HPP will be calculated with respect to the HPP patient population, expressed per 100,000 of population. Mortality rates will be calculated and reported as annual period mortality per year of the prevalence period, and as 5-year mortality across the period 2018-2022. Mortality rates will be reported for the full HPP patient population, and stratified by age (paediatric/adult) and sex.Procedures and referrals:
Procedures and referrals will be summarised as any occurring in the prevalence period (2018-2022), in those patients captured in the prevalence period cohort (2018-2022); in addition, for prevalent patients in the year 2022, procedures and referrals will be reported as conditions occurring within that year. Procedures will be reported as the top 10 across each period (ranked by unique patient counts), stratified by age (paediatric/adult); referrals will be reported separately in the same manner.Treatments:
Treatments will be summarised as follows: i) any occurring within the prevalence period (2018-2022)/the year 2022, for those patients captured in the prevalence cohort (2018-2022)/prevalent in 2022; ii) any instance of key HPP-specific treatments (asfotase alfa), for those patients captured in the prevalence cohort (2018-2022)/the year 2022. Treatments will be reported separately for the prevalence period/the year 2022 as: i) the top 10 (ranked by unique patient counts), stratified by age (paediatric/adult); and ii) frequencies of asfotase alfa, stratified by age (paediatric/adult).Description: Lay Summary
Hypophosphatasia (HPP) is a rare genetic disease, which leads to poor mineralization of bones and also affects other body systems. HPP may first emerge at any age, presenting in infancy, childhood or adulthood. HPP is associated with a range of complications including infantile rickets (e.g., growth failure, bowed legs), fractures, dental caries (e.g., cavities), bone pain, muscle weakness, and seizures that respond to vitamin B6. HPP is caused by a form of the ALPL gene, which disrupts a chemical called alkaline phosphatase present in the bones, liver and kidneys. Although HPP has been studied in the UK previously, relatively few studies have looked at the population level to understand the overall extent of HPP across the UK, or the characteristics of the patient population living with HPP.
This study aims to provide an updated estimate of the extent (prevalence) of HPP in the UK, overall and by adult versus childhood forms. This will enable a more detailed understanding of HPP and its impact in the UK. This is expected to confer a public health benefit by establishing an up-to-date overview of the disease burden of HPP overall and by age in the UK; this may help to increase rates of HPP detection and treatment.
Technical SummaryHypophosphatasia (HPP) is a rare heritable metabolic disease affecting the musculoskeletal system and tooth mineralisation. HPP is caused by low activity of tissue-nonspecific alkaline phosphatase, arising from pathogenic mutations of the ALPL gene. Clinical presentation typically includes rickets (in infants and children), dental caries and premature tooth loss, osteomalacia with fractures and pseudofractures, pain, myopathy and ambulatory challenges. There is a lack of current, large-scale studies of the epidemiology of HPP in the UK. The aim of this study is to provide an updated estimate of the prevalence of HPP in the UK, overall and by adult/paediatric forms. The study population will be primary care patients within the UK, with a HPP diagnosis recorded during the period January 1st 2000 to December 31st 2022. This is an observational, cross-sectional study using data collected from primary care, via patient encounters with their GP. Data sources for the study will be CPRD Gold and CPRD Aurum â linked with ONS mortality records. Descriptive analyses will be applied to understand the comorbidities, procedures, treatments and mortality associated with the study population; no inferential testing or statistical modelling will be performed. Descriptive analyses will include: estimation of prevalence proportions; mortality rates; and summaries of the frequencies (i.e., Ns, %) of comorbidities, procedures and treatments within the period of prevalence estimation (2018-2022). The intended public health benefit of the study will be to help better understand the HPP burden in the UK. This may be of benefit in the development of better patient identification and diagnosis strategies, together with improving HPP clinical management and disease outcomes.
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Preventing steroid harms in people with polymyalgia rheumatica in England primary care - assessing the effect of prophylactic medications on fragility fractures and gastro-intestinal adverse events: a retrospective cohort study — Helen Twohig ...
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Preventing steroid harms in people with polymyalgia rheumatica in England primary care - assessing the effect of prophylactic medications on fragility fractures and gastro-intestinal adverse events: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-23
Organisations:
Helen Twohig - Chief Investigator - Keele University
David Jenkinson - Corresponding Applicant - Keele University
Ian Scott - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Samantha Hider - Collaborator - Keele University
Sara Muller - Collaborator - Keele UniversityOutcomes:
Fragility fractures; Gastrointestinal adverse events (peptic ulcer disease and upper gastrointestinal bleeds)
Description: Lay Summary
Polymyalgia rheumatica is an illness affecting older adults. It causes pain and stiffness around the shoulders and hips and can affect peopleâs ability to do everyday activities. The main treatment is steroid tablets (prednisolone), which need to be taken for around two years but sometimes longer.
Prednisolone can cause side-effects including increasing the chances of people breaking bones and bleeding from the gut. People with polymyalgia rheumatica have told researchers that understanding more about the side-effects of steroids and how to prevent them is important. Some medicines given to treat pain in polymyalgia rheumatica also increase the chances of bone and gut problems. There are other medicines that can be given to reduce the chances of these side-effects happening (called âpreventative medicinesâ), but low numbers of people receive these.Using information from peopleâs anonymous primary care medical records, linked to data from hospital admissions and local area deprivation data, we will find out:
- the effect of preventative medicines on the chances of having fractures / gut side-effects
- what the effect on the health of people with polymyalgia rheumatica, as a group, would be if preventative medicines were prescribed in the way guidelines suggest.We will discuss the findings with our study patient group to ensure we produce information that is helpful to people with polymyalgia rheumatica and healthcare staff that care for them. This study will help us to better treat people diagnosed with polymyalgia rheumatica.
Technical SummaryPolymyalgia rheumatica (PMR) causes pain, stiffness, and disability in older adults. It typically responds rapidly to glucocorticoids (GCs) with the dose being tapered over 2-3 years.
Two risks associated with GCs are an increased rate of fractures and serious gastrointestinal (GI) adverse events. Pharmacological strategies to reduce the risk of complications exist, but studies show that prescribing of prophylactic medication is low. Additionally, analgesia used to manage pain in PMR can contribute to risks of fractures and GI adverse events. We will conduct two emulated âtarget trialsâ to look at the effect of prescribing prophylactic 1) bisphosphonates and 2) gastro-protective medications on incidence of 1) fracture and 2) GI adverse effects, respectively. This study will use CPRD Aurum primary care data, linked Hospital Episode Statistics Admitted Patient Care Data (HES APC, to improve outcome ascertainment) and indices of multiple deprivation quintiles (to adjust for levels of deprivation).
A retrospective cohort of people with incident PMR treated with GCs (January 2010 and March 2022) will be formed in CPRD Aurum. Date of steroid prescription will be the time zero for the emulated trial. Those with a prescription for 1) an oral bisphosphonate; or 2) gastro-protective medicines before time zero will be excluded. Outcomes will be 1) fragility fractures and 2) GI bleeding, defined in Aurum and HES APC. We will estimate causal average treatment effects (with 95% confidence intervals and p-values) on the outcomes at 1 year after time zero of being treated compared to not being treated, using targeted maximum likelihood estimation (for example, using R package ltmle), with 1-month time intervals, and time-varying treatments and confounders.
Findings will be discussed with our study patient group to ensure we produce outputs helpful to both patients and clinicians and thus impact meaningfully on the future treatment of people diagnosed with PMR.
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The association between type 2 diabetes and glucose-lowering therapies and the risk of all-cause mortality and diabetes complications — Craig Currie ...
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The association between type 2 diabetes and glucose-lowering therapies and the risk of all-cause mortality and diabetes complications
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-15
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Aron Buxton - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Chris Shepherd - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christian Bannister - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Harry Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
James Bateman - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Lauren Riddick - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Rhiannon Thomason - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Eye disease related to diabetes; Nephropathy; revascularisation; Major adverse cardiac events (MACE); Myocardial infarction; Stroke; Neuropathy; All- cause mortality; Time to initiation of a glucose-lowering therapy.
Note to reviewer: This section should clearly list the primary and key secondary outcomes of interest in a concise list, separated by semicolons. Therefore, we cannot elaborate on the outcome definitions in this section. All outcome definitions are included in the âExposures, Outcomes and Covariatesâ section.
Description: Lay Summary
Type 2 diabetes is a common lifelong condition characterised by high blood sugar. People with type 2 diabetes are at risk of developing long-term problems affecting the heart, kidneys, eyes and nerves. Type 2 diabetes can be managed by improving diet and increasing exercise, but medication to lower blood sugar is frequently also required.
Technical Summary
It is unclear to what extent improvements in diabetes care have improved the health of people with type 2 diabetes. This, combined with the introduction of new drug treatments, warrants further research into the condition. The aim of this research is to help us to understand the association between having type 2 diabetes and the risk of death and developing the long-term problems listed above and whether this has changed in recent years. In addition, we aim to investigate the association between different treatments for type 2 diabetes and the occurrence of these problems. We hope our findings will be used to support results from clinical trials elsewhere and to inform further investigation.The aim is to investigate the association between type 2 diabetes and the development of complications of diabetes and death. We will also investigate the association between glucose-lowering therapies and the same outcomes in people with type 2 diabetes.
Patients will be selected from the Clinical Practice Research Datalink (CPRD) GOLD and Aurum datasets if they have a record of one or more of the following: a product code indicative of a glucose-lowering therapy; or a medical code indicative of diabetes in CPRD or linked Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Outpatient data. Patients will be classified as having type 2 diabetes by applying a series of previously published decision rules based on diagnoses, prescriptions for glucose-lowering therapies, body mass index (BMI) and haemoglobin A1c (HbA1c).
The following outcomes will be investigated using CPRD, linked HES APC and Outpatient data and Office for National Statistics (ONS) Death Registration data: eye disease related to diabetes; nephropathy; revascularisation; major adverse cardiac events (MACE); myocardial infarction; stroke; neuropathy, all-cause mortality, time-to-initiation of a glucose-lowering therapy. The date of death recorded in the ONS death registration data will take precedence over the CPRD-derived date of death where available. Cases of type 2 diabetes will be compared with a matched control group without a record of diabetes. In a subgroup analysis, glucose-lowering therapies will be compared. Time to endpoint will be evaluated using Cox proportional hazards modelling. If the proportional hazards assumption is not met, we will use a parametric survival model.
This study will provide valuable information on the impact of type 2 diabetes and the effectiveness of glucose-lowering therapies on long term diabetes related outcomes and could be used in addition to randomised controlled trials to help support healthcare decision-making.
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Comparing several pancreatic cancer risk scores or models regarding the diagnostic performance and availability of necessary parameters in primary care records of a cohort of patients with recently diagnosed diabetes mellitus — Susan Jick ...
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Comparing several pancreatic cancer risk scores or models regarding the diagnostic performance and availability of necessary parameters in primary care records of a cohort of patients with recently diagnosed diabetes mellitus
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2024-01-23
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
- Corresponding Applicant -
Bernhard Egger - Collaborator - University of Fribourg ( Switzerland )
Christoph Meier - Collaborator - University of Basel
Claudia Mellenthin - Collaborator - University of Basel
Leo Buhler - Collaborator - HFR FribourgOutcomes:
The clinical outcome of interest in this study is incident PDAC in patients with adult onset diabetes. The main âtechnicalâ outcomes of the study are
⢠the diagnostic performance of published risk scores/models for PDAC prediction
⢠the diagnostic performance and usefulness of these scores/models in cases with missing dataDescription: Lay Summary
Pancreatic cancer is a serious but rare disease, often leading to death within a year of finding it. Only about 10% of patients live 5 years or longer. Discovering it early is tough because symptoms typically appear after the cancer has spread. Unfortunately, there is no available test to find the disease before symptoms show up.
Recent observations suggest that blood sugar levels often rise before a pancreatic cancer diagnosis, leading to high blood sugar (diabetes), which might be a window of opportunity for early diagnosis. However, testing all new patients with high blood sugar for pancreatic cancer is not practical, as sugar disorders are very common, and less than 1% percent of them have pancreatic cancer detected in the first 3 years after finding the sugar disorder.
To address this, various tools have been created to estimate the risk of pancreatic cancer in those with recently found sugar disorders. These tools use basic patient information or early symptoms. In our proposed research, we aim to compare these tools using data from real-world primary care settings. We intend to determine which ones are most accurate in finding pancreatic cancer and which are practical for use by family doctors.
Technical SummaryAmong pancreatic cancer patients, blood glucose levels slowly increase as early as 10 years before pancreatic ductal adenocarcinoma (PDAC) diagnosis. New onset diabetes (NOD) or even prediabetes could be a potential signal for the early diagnosis of pancreatic cancer. As pancreatic cancer is responsible for only about 0.8% of NOD cases, screening every patient with NOD might lead to an unfavorable risk/benefit ratio.
Several scores or models have been developed to enrich the population, to increase the feasibility of a screening program.
In this proposed study, we intend to evaluate the diagnostic performance and availability of necessary parameters in primary care records for published diagnostic scores and models that have been developed to find pancreatic cancer in adult patients with new onset diabetes. We will select a cohort of patients with NOD, aged 30-90 years between 2002 and 2018(index date), and follow them until they develop pancreatic cancer or are censored. We will extract the information needed to calculate the risks scores or prediction models and will assess their diagnostic performance by calculating their respective AUC, sensitivity, specificity, and positive and predictive values. We will also assess the fitness of these scores and models for application in primary care, i.e. whether the information needed for the calculations is frequently assessed in routine primary care, or whether we encounter a lot of missing information. We will further assess their diagnostic performance with several strategies regarding missing data (complete case, imputations, best/worst case assumptions, etc).
As 5-year survival of PDAC is only about 10%, in part due to its delayed diagnosis, the benefit of an early diagnosis could be high. The highly traumatic impact of these cancer deaths, often within months after diagnosis, is great. This study has the potential to greatly improve public health for patients with PDAC.
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ID-382: New care pathway to support patients with Heart Failure with Preserved Ejection Fraction — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-382: New care pathway to support patients with Heart Failure with Preserved Ejection Fraction
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-24
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart failure.
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ID-384: Recurrent UTI Prevalence — University of Oxford...
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ID-384: Recurrent UTI Prevalence
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-24
Opt Outs: no information provided./p>
Organisations: University of Oxford
Description: UTI prevalence.
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ID-383: VERVE-101 — Imperial College Health Partners...
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ID-383: VERVE-101
Legal basis:Cohort Recruitment
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-24
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Safety of VERVE administered to patients. Commercial
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ID-385: Long term surveillance of patients on the Lipid Management Pathway — Imperial College Healthcare NHS Trust...
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ID-385: Long term surveillance of patients on the Lipid Management Pathway
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-24
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Cardiovascular disease. Commercial
Source
2023 - 12
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Retrospective cohort analysis using Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) to investigate adherence to androgen deprivation therapy (ADT) in patients with prostate cancer — Craig Currie ...
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Retrospective cohort analysis using Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) to investigate adherence to androgen deprivation therapy (ADT) in patients with prostate cancer
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-29
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Nick Denholm - Corresponding Applicant - Harvey Walsh Ltd
Emily Wilkes - Collaborator - OPEN Health Group
John Robinson - Collaborator - Harvey Walsh Ltd
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Mark McCormack - Collaborator - Harvey Walsh Ltd
Stephen Boult - Collaborator - Harvey Walsh LtdOutcomes:
The below will be measured overall and stratified by COVID-period (patients assigned to COVID-period by date of patientsâ first ADT injection prescription [index])
Treatment patterns:
-Length of follow-up time, average number of injections of an LHRH agonist or GnRH antagonist over follow-up time.
-Proportion of days covered by drug formulation,
-Treatment delays (continuous and categorical: <4 days (no delay), 4 â 6 days, 7 â 13 days, 14 - 27 days, â¥28 days) by drug formulation
-Treatment interruptions (% of patients with an interruption by type and frequency per patient, defined as a gap in treatment >6 months before another ADT injection is administered) by drug formulation
-Treatment discontinuation (% of patients with a discontinuation by type, defined as a gap >6 months with no further ADT therapy observed) by drug formulation
-Treatment switching (% that switch ADT) by drug formulationDemographics and clinical characteristics:
age at diagnosis; age at index; year of index; ethnicity; socio-economic status (IMD quintile); NHS region of GP practice; metastatic status of prostate tumour at diagnosis; PSA levels; comorbidities (including obesity, anxiety depression); concomitant prescriptions to ADT (including anti-androgens, biphosphates, statins, diabetes medications, antiplatelet therapies, alpha-blockers, non-opioid analgesics, angiotensin-converting enzyme inhibitors, beta-adrenoreceptor blocking drugs, calcium channel blockers); death during the study periodSafety events:
Major Adverse Cardiovascular Events (MACE) (including Myocardial infarction, Non-fatal stroke, Cardiovascular death) and MACE-related adverse events (nervous system haemorrhages and cerebrovascular conditions), Composite MACE (first of myocardial infarction, non-fatal stroke or cardiovascular death); Safety events (including hypertension; non-fatal stroke; myocardial infarction; osteoporosis; fractures; urinary tract infections; impotence/erectile dysfunction, type II diabetes);HCRU:
HCRU from index to follow up, all-cause and prostate-cancer specific (including primary care consultations; primary care prescriptions, primary care prescriptions for ADTs of interest, primary care laboratory tests of interest (including, blood pressure, lipid panels, HbA1c testing), secondary care prescriptions, inpatient admissions, length of inpatient stay, outpatient attendance, referral to cardiology specialist, accident and emergency visits, cost of primary care prescriptions, cost of all care, cost of prostate-cancer specific care.Description: Lay Summary
Prostate cancer is one of the most common cancers diagnosed worldwide and a leading cause of cancer related deaths in men. Men with advanced prostate cancer may be prescribed Androgen Deprivation Therapy (ADT), which lowers levels of the hormone testosterone, aiming to slow or stop growth of prostate tumours. There are two main types of ADT used in the UK for treating prostate cancer, long-acting luteinising hormone-releasing hormone (LHRH) agonists and gonadotropin-releasing hormone (GnRH) antagonists.
This study aims to describe current experiences of patients receiving ADT in the UK by type (LHRHs and GnRHs). Specifically, how frequently people with prostate cancer receive ADT prescriptions, if this is different from the plan for their treatment, and whether they experience delays, interruptions or stop their treatment early. The study will also describe the disease characteristics of people with prostate cancer receiving ADT, and how often they receive medical care after starting their ADT treatment. Finally, the study will also describe patientsâ experience on ADT treatment before, during and after the COVID-19 pandemic.
Understanding treatment patterns and associated medical care received by patients on ADT will have a public health benefit in helping to describe any unmet need in the treatment of patients with prostate cancer, including understanding whether there are issues with treatment adherence, preventing patients from taking ADT medication as prescribed.
The study will use electronic health records from Clinical Practice Research Datalink linked to data from Hospital Episode Statistics (HES) and the Office for National Statistics (ONS).
Technical SummaryThis study aims to describe treatment patterns, safety outcomes and healthcare resource use (HCRU) in adult patients with prostate cancer, treated with an Androgen Deprivation Therapy (ADT). Our study population will have a diagnosis of prostate cancer at any time and a first prescription for an ADT (injectable LHRH agonist or GnRH antagonist) from 1st April 2015 in CPRD.
Our primary exposure will be treatment with an ADT. CPRD data will be used to assess patient demographics, treatment patterns, safety outcomes and primary-care HCRU. Linked HES data will be used to assess safety outcomes and secondary-care HCRU (hospital admissions, outpatient visits, relevant procedures, and emergency visits).
This is a retrospective cohort study. Our analysis will be presented overall, by ADT agent and formulation and stratified by pre-, during- and post- COVID pandemic periods. Patients will be followed-up from first ADT prescription.
Descriptive statistics will describe:
-Patient characteristics (e.g., prostate-specific antigen [PSA] levels); comorbidities and concomitant treatments
-Treatment patterns, including patient adherence to ADT proxied by proportion of days covered (PDC), treatment delays, interruptions, discontinuation and switching, each defined by pre-specified time gaps within which another ADT treatment is not prescribed. Only CPRD based prescription information will be available for this analysis
-Safety outcomes of interest (e.g. hypertension, bone health)
-All-cause and prostate cancer-specific HCRUCox proportional hazard modelling will be used to describe incidence of major adverse cardiovascular (MACE) and other cardiovascular-related safety outcomes of interest.
Using CPRD-HES will provide real-world evidence of the usage and outcomes following treatment with ADT in prostate cancer patients in England. Understanding treatment patterns and associated HCRU of patients on ADT will have a public health benefit in helping to describe any unmet need in the treatment of patients with prostate cancer that may be leading to treatment disruptions or adverse outcomes.
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Evaluation of foot screening in primary care in people with diabetes in England — Robert Hinchliffe ...
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Evaluation of foot screening in primary care in people with diabetes in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-27
Organisations:
Robert Hinchliffe - Chief Investigator - University of Bristol
Robert Hinchliffe - Corresponding Applicant - University of Bristol
Aleksandra Staniszewska - Collaborator - University of Bristol
Frank de Vocht - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of BristolOutcomes:
Major lower limb amputation (composite of below the knee, above the knee, through knee and hindquarter amputations); admission to hospital for foot related problems, length of hospital stay, foot ulceration, death; revascularisation procedure (any of extra-anatomical bypass, iliac bypass, iliac angioplasty, femoro-proximal bypass, femoro-distal bypass, femoral angioplasty, unspecified lower limb angioplasty
Description: Lay Summary
Background:
Diabetes, a disease characterised by high blood sugars, is common affecting 1 in 10 of people in the UK. It can cause major circulatory and nerve damage, predisposing to tissue damage of the feet that may lead to leg amputation. General Practitioners have been encouraged to detect the early signs of foot disease through their NHS contract in 2004. Specialist treatment could then be offered to reduce the chances of amputation. However, we do not know whether this programme to find the early signs of foot disease has been effective in lowering the numbers of amputations.Aims:
Our study will evaluate screening for foot disease in primary care. It will investigate whether:
i. number of amputations in patients with diabetes have decreased since the introduction of screening in 2004
ii. primary care screening examinations effectively pick out patients at high risk of amputation
iii. screening can be improved by a computer model to predict amputation risk
iv. patients with diabetes receive screening fairly, irrespective of age, gender or social positionDesign and methods:
Technical Summary
The study will use a large, anonymised database of general practice records called Clinical Practice Research Datalink, which is linked to hospital data, to answer these questions. The analysis will provide important information on whether current care for patients with diabetes in England is effective in preventing amputations and whether screening could be improved using a computer model to assess individual risk.Background:
Diabetes mellitus affects 4.9 million individuals in the United Kingdom. Approximately 25% of patients with diabetes develop foot ulceration during their life and 80% of amputations are preceded by a foot ulcer. Since 2004, General Practitioners in England have been encouraged to perform annual foot screening for patients with diabetes. It remains unclear whether the introduction of screening has affected patient outcomes.Aims:
The aims are to investigate:
1. The effectiveness of screening for the early signs of foot disease in diabetes in primary care
2. The predictive performance of the screening tests
3. The equity of uptake to identify opportunities for optimising careMethods:
Aim 1 will be addressed using controlled interrupted timeseries to examine amputation rates in populations with and without diabetes and the effect of the introduction of primary care incentives in 2004 on these trends. A sensitivity analysis will be performed for 2004-2010 and 2011-2019 periods to reflect the modification of the screening criteria.Aim 2 will be achieved using a retrospective cohort design with the outcome of screening tests among people with diabetes as the main exposure and amputation as the main outcome.
Aim 3 will be addressed using a repeat cross-sectional design to examine the relationship between uptake of screening and demographic and clinical characteristics. A multidisciplinary panel meeting composed of patients and relevant stakeholders will be held to discuss current issues with foot screening and formulate recommendations for future improvements.
Impact and dissemination:
The results of the study will be presented at the national and international vascular and diabetes meetings and published in leading peer-review journals by the end of 2027. The findings will provide good quality evidence to either support ongoing foot screening in the community or encourage development of alternative interventions to improve outcomes in patients with diabetic foot disease.
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Disease epidemiology and drug utilisation for disease-specific treatments of regulatory interest — Daniel Prieto...
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Disease epidemiology and drug utilisation for disease-specific treatments of regulatory interest
Datasets:GP data, HES Admitted Patient Care; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-07
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Kim López-Güell - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Marta Pineda Moncusi - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
Incidence and/or prevalence of disease of regulatory interest and/or pre-specified drug(s) of interest, Drug Utilisation
Description: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe.
One area of research relates to estimating how common a specific condition is among the general population, and how drugs to treat that condition are used in people recently diagnosed with that condition. For regulators such as the EMA, it is important to have access to this kind information as it helps to understand the uptake of specific drugs over time.
The objective of each of those studies is to (1) describe how common a condition the EMA is particularly interested in among the general population, (2) to estimate the number of new and existing users of drugs used to treat that condition, (3) we summarise characteristics of patients taking those drugs in terms of their age, sex, other conditions they were diagnosed with or drugs they were prescribed at the time they start treatment. Where relevant, we also describe how the drugs are being used in terms of duration, dose or sequence of different medicines.
The EMA will request several studies of the same design to assess the use of drugs in people with conditions that are of particular interest to them. The first example will focus on the use of a medicine called âpeginterferoneâ in people with a chronic infection of the liver (chronic hepatitis).
Technical SummaryPrimary care records provide a unique source of data for estimating the incidence and prevalence of diseases of regulatory interest and their specific drug treatments used in the community. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the utilisation of specific drugs in people with diseases of regulatory interest, EMA will commission several drug utilisation studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: All people in CPRD GOLD and CPRD Aurum with >=1 year of prior history comprise the source population. Among those, people with the pre-specified disease of regulatory interest will be selected.
Variables: Conditions and drug exposure based on prescription data based on SNOMED codes and RXNorm codes in the mapped data. In addition, the characteristics of patients being prescribed the drug(s) of interest will be described, and the use of the prescribed medicines assessed in terms of duration, dose or treatment sequence.
Disease/drug combinations of regulatory interest as expressed by EMA:
- Chronic Hepatitis B/C and use of peginterferone and specific antivirals
Additional disease/drug combinations of regulatory interest will be declared in future protocol amendments upon request by EMA to the DARWIN Coordination Centre.
Analyses:
(1) Incidence and/or prevalence of the disease of regulatory interest in the general population
(2) Incidence and/or prevalence of prescriptions of pre-specified drugs in newly diagnosed patients with disease of regulatory interest
(3) Summary characteristics of newly diagnosed patients at the time of starting treatment with pre-specified medicines
(4) Utilisation of pre-specified medicines in terms of duration of use, dose or treatment sequence.
All analyses will be stratified by age, sex, and calendar year where relevant.
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Antipsychotics and Type 2 Diabetes in Children and Young People: A Population-based Study — Wallis Lau ...
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Antipsychotics and Type 2 Diabetes in Children and Young People: A Population-based Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-07
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Sohee Park - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )Outcomes:
Incident type 2 diabetes mellitus (T2DM), defined by a record of diagnosis or a prescription of antidiabetic drugs (other than insulin) after initiation of antipsychotic drugs.
Description: Lay Summary
Antipsychotics are medications commonly prescribed to treat mental health conditions such as psychosis (losing touch with reality). They are also prescribed to treat anxiety and irritability in children with autism, a condition that affects the way a person thinks and interacts with the world, improving the lives of both the child and the family. However, adverse effects, including weight gain and insulin resistance (occurs when the body's cells do not respond well to insulin, leading to higher levels of blood sugar in the bloodstream), have been observed in adults using antipsychotics. As a result, there are now concerns about the potential risk of developing type 2 diabetes mellitus (T2DM), a condition that leads to difficulties in managing blood sugar levels, among children and young people taking antipsychotics.
The aim of this study is to evaluate the long-term risk of developing T2DM among children and young people treated with antipsychotics. We will:
1. Examine the cumulative incidence of T2DM among children and young people treated with antipsychotics, and how this is affected by age at treatment initiation, sex, and ethnicity.
2. Determine the risk factors associated with the development of T2DM in children and young people treated with antipsychotics.
3. Evaluate the risk of T2DM according to the type of antipsychotic and duration of use.Against the background of this information, our overall goal is to develop guidance for clinicians and patients to reduce the risk of developing T2DM among children and young people taking antipsychotics through risk factor modification.
Technical SummaryThis will be a population-based cohort study that includes children and young people who were aged <18 years and newly prescribed antipsychotics between 1990-2017. Patients who had a diagnosis for T1DM anytime during the study period or had a diagnosis for T2DM before the first antipsychotic prescription will be excluded. The cohort will be followed until 31 December 2022 (or the latest available data). The outcome will be incident T2DM defined by a record of diagnosis or a prescription of antidiabetic drugs other than insulin. We will investigate 1) cumulative incidence of T2DM yearly, stratified by age at treatment initiation, sex, and ethnicity, 2) the risk of T2DM according to the types of antipsychotics and duration of use, and 3) the risk factors associated with the development of T2DM with antipsychotic medication in children and young people. Covariates will be included based on previously published findings of potential risk factors for T2DM, such as age, sex, ethnicity, sociodemographic status, family history of diabetes, body mass index (BMI), disease and medication history. Childhood BMI will be transformed using the Lambda Mu Sigma method. Comorbidities will be measured any time before and on the first antipsychotic prescription (cohort entry). Co-medications will be assessed within the year before and on the cohort entry. In our analysis, we will use the Cox proportional hazard regression models to examine risk factors for T2DM. To analyse duration-response relationship, drug exposure status will be updated monthly and presented as a time-dependent exposure variable in the Cox model. Cumulative duration of use will be defined as the total number of days of use since the cohort entry. The study finding will help clinicians and patients better understand and reduce the potential risk of T2DM in children and young people taking antipsychotics.
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Epidemiological analysis of inflammatory eye and central nervous system conditions and their risk factors, association with infectious and immune-mediated inflammatory diseases, and health impacts. A UK population-based observational study — Tasanee Braithwaite ...
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Epidemiological analysis of inflammatory eye and central nervous system conditions and their risk factors, association with infectious and immune-mediated inflammatory diseases, and health impacts. A UK population-based observational study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-27
Organisations:
Tasanee Braithwaite - Chief Investigator - King's College London (KCL)
Benjamin Zuckerman - Corresponding Applicant - King's College London (KCL)
- Collaborator -
Alasdair Warwick - Collaborator - University College London ( UCL )
Alastair Denniston - Collaborator - University of Birmingham
axel petzold - Collaborator - University College London ( UCL )
Chiara Rocchi - Collaborator - Walton Centre NHS
James Galloway - Collaborator - King's College London (KCL)
Mark Russell - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Nicola Adderley - Collaborator - University of Birmingham
Pavel Loginovic - Collaborator - University of Exeter
Saif Huda - Collaborator - Walton Centre NHS
Tsz Lun Ernest Wong - Collaborator - King's College London (KCL)Outcomes:
Primary outcome
⢠Frequency and strength (odds and/or hazard ratio) of association between incident inflammatory eye and central nervous system conditions (and their subtypes) and I-IMIDs (preceding or following eye/CNS inflammatory condition diagnosis), or preceding covid-19 vaccination, or preceding associated medication.
Key secondary outcomes for inflammatory eye/CNS conditions (and subtypes):
⢠Annual point prevalence and trend 2013 to 2022;
⢠Annual incidence rate and trend 2013 to 2022;
⢠Cumulative incidence rate ratio, by associated risk factor variables;
⢠Hazard of negative health outcomes of inflammation or its treatment: vision impairment; sight impairment registration; neurological disability (wheelchair use); ocular complications; incident depression/anxiety, diabetes, hypertension, sepsis, fragility fracture, cancer, or infertility.Description: Lay Summary
The eye and spinal cord are part of the nervous system and can rarely become inflamed in response to infections, immune system diseases, vaccination or certain medicines. Inflammation can threaten sight, or strength and feeling in the body. Timely diagnosis and treatment can prevent permanent damage, but treatments may cause other health problems. Some tests used to work out the underlying causes, and some treatments, are expensive and it can be challenging to determine which ones are most helpful.
Lack of data on these rare inflammatory conditions of the eye and spinal cord has made it difficult to:
i) anticipate current and future NHS workforce needs;
ii) anticipate future demand for high-cost treatments;
iii) order appropriate tests; and
iv) understand health and vision outcomes.Our study aims to extend previous research on a smaller dataset from a UK primary care records database to better understand eye and spinal cord inflammation. We will estimate how common these types of inflammation are in the population, and whether that changed during the COVID-19 pandemic. We will estimate how frequently these inflammatory conditions are linked to an underlying disease, vaccine or medicine, consider risk factors for their onset, and their impacts on the eye and general health. These findings could support improvement in NHS healthcare services.
Technical SummaryBackground: Tissues within the eye are an extension of the central nervous system (CNS). They may become inflamed in infectious and immune-mediated inflammatory diseases (I-IMIDs), or following COVID-19 vaccination, or medications (e.g bisphosphonates), with irreversible damage and loss of function. Associated I-IMID diagnosis (e.g multiple sclerosis, rheumatoid arthritis, syphilis) may precede presentation or follow months or years later. Treatment also carries risk of complications.
Objectives:
To replicate and extend previous primary care record analyses of uveitis, scleritis, and optic neuritis, to add associated phenotypes including episcleritis, peripheral ulcerative keratitis, and transverse myelitis;
1) To estimate 10-year incidence/prevalence trend (2013-2022), before/during COVID-19 pandemic;
2) To estimate how incidence rate varies by established risk factors including age group, sex, ethnicity, body mass index, smoking, latitude, and vitamin D deficiency;
3) To comprehensively and systematically estimate frequency and strength of association with associated I-IMIDs diagnosed before or after incident eye/CNS inflammation, or with preceding associated medications, or COVID-19 vaccination;
4) To estimate negative health impacts including hazard of ocular complications, sight impairment registration, neurological disability, incident depression/anxiety, diabetes, hypertension, sepsis, fragility fracture, cancer, and infertility.Methods: Population: Patients aged >1 year with a recorded diagnosis of an inflammatory eye condition (uveitis, scleritis, episcleritis, peripheral ulcerative keratitis, optic neuritis or transverse myelitis). Study designs: Cross-sectional (2013-2022), population cohort, and matched case-control and matched cohort study designs (all years). Statistical analyses: annual incidence, annual point prevalence, multivariable Poisson regression analysis offsetting for person-years, multivariable logistic regression analysis and multivariable Cox proportional hazards regression analysis. Matching 1:4 on age, sex, region and deprivation index. Additional adjustment variables may include ethnicity, BMI, nation, smoking, vitamin D and COVID-19 vaccination status.
The findings could support workfoce planning, estimating demand for immunosuppressives, including high-cost biologics, targeting investigations and referrals, and quantifying health outcomes.
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Reinforcement Learning approach to evaluate and rank AI models that use clinical parameters to predict hospitalisation and mortality of adults with Multiple Long-Term Conditions — Clare Bankhead ...
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Reinforcement Learning approach to evaluate and rank AI models that use clinical parameters to predict hospitalisation and mortality of adults with Multiple Long-Term Conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-27
Organisations:
Clare Bankhead - Chief Investigator - University of Oxford
Sami Adnan - Corresponding Applicant - University of Oxford
Amitis Shidani - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Lei Clifton - Collaborator - University of Oxford
Madhu Vankadari - Collaborator - University of Oxford
Rafael Perera - Collaborator - University of Oxford
Robert Williams - Collaborator - University of Oxford
Subhashisa Swain - Collaborator - University of OxfordOutcomes:
- Health Outcomes
The health outcomes used in this research will be hospitalisation and all-cause mortality.
We will first train and implement AI/ML models for predicting all-cause mortality rates and hospitalisation.
- AI/ML Outcomes
We will derive an explainability score for the reinforcement learning approach to establish the evaluation criteria by ranking of different statistical and AI/ML models to predict the above health outcomes in one or more long-term conditions.
The error rate or success rate of these models is used for the bandit learning problem, where we run different bandit learning problems for each cohort. This is done in the online setting of bandit learning, where the objective is to minimise the total expected error rate over time or, in other words, maximise the total expected success rate over time. The output of the bandit learning problem is the best ranking of AI/ML models at each time-step, which maximises the success rate. The explainability of the models would also be considered using explainability methods [1] that can produce an explainability score. This score can be used for the ranking of the bandit learning problem. Finally, at the end of the desired period (the horizon), we arrive at the optimal ranking of these algorithms for each cohort.
Description: Lay Summary
People with multiple long-term conditions suffer from two or more long-term illnesses, which is a growing public health challenge as it significantly impacts health and social care systems. It can lead to poorer quality of life, make healthcare more expensive, and affects certain groups of people, mostly as we age.
Recently, Machine Learning (ML), one branch of Artificial Intelligence, has been suggested to solve some challenges when dealing with multiple long-term conditions. These challenges range from understanding higher risks of other diseases to deciding which treatments to take, as some might be in conflict, increasing adverse reactions. One problem with this approach is that there needs to be clear guidance about which of the multiple ML tools is best, as their performance is difficult to link with important health outcomes (mortality and hospitalisation).
This project aims to fill this gap by setting criteria for the evaluation of these tools. This study will evaluate different and competing ML models using a computer learning approach that can rank them based on their performance. This project will therefore have a long-term impact on reducing the public health burden while increasing the chances of using appropriate tools in the near future.
Technical SummaryArtificial Intelligence (AI) systems with machine learning (ML) predictive models can help us understand common patterns associated with multiple long-term conditions. We aim to develop evaluation criteria for competing AI/ML models utilising bandit learning (BL) algorithms for self-supervised reinforcement learning. Following models variants will be trained: logistic regression, k-nearest neighbours, random forest, gradient boosting machines, convolutional neural networks, recurrent neural networks, support vector machines, and variational autoencoders.
We target eighteen conditions: anxiety, asthma, atrial fibrillation, cancer, coronary heart disease, chronic kidney diseases, chronic obstructive pulmonary diseases, dementia, depression, diabetes, heart failure, hypertension, Parkinsonâs disease, peripheral vascular diseases, schizophrenia, stroke, rheumatoid arthritis, and osteoporosis.
Study design: four cohorts of adults aged: 18-44, 45-64, 65-84, and 85+ on 30th June 2005 and followed up to date. Minimum of 2-years follow-up from index date, ideally with long-term follow-up. Population of interest (each cohort): confirmed cases of any target condition (described above).
First primary objective: define evaluation criteria for new diagnostic strategies from prediction models based on:
(EXPOSURES) individual characteristics (e.g. age, sex), biomarkers (e.g. cholesterol, creatinine), health behaviours/risk factors (e.g. smoking, alcohol use), target conditions, and socioeconomic factors (e.g. deprivation score). OUTCOMES targeted: all-cause mortality and hospitalisation. OUTCOMES will be used as performance parameters for error rate or success rate as EXPOSURES for assigning clinical parameters as rewards functions of the bandit learning evaluation, again with OUTCOMES targeted for all-cause mortality and hospitalisation. This is a two-step process, meaning candidate models use EXPOSURES to predict the OUTCOME so that the model's PREDICTED OUTCOME is taken as the OUTPUT of the model. Then to evaluate, the bandit learning compares each model's PREDICTED OUTCOME with the actual OUTCOME.Second primary objective: the development and testing of a technical framework that will enable stakeholders to better create, deploy, and maintain scalable and explainable automatic prediction models.
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Longitudinal Treatment Patterns, Health Outcomes and Costs of Cancer Associated Thrombosis (CAT) in the United Kingdom: A Real-World Study Using Clinical Practice Research Datalink (CPRD) — Mihail Samnaliev ...
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Longitudinal Treatment Patterns, Health Outcomes and Costs of Cancer Associated Thrombosis (CAT) in the United Kingdom: A Real-World Study Using Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-05
Organisations:
Mihail Samnaliev - Chief Investigator - Stratevi
Mihail Samnaliev - Corresponding Applicant - Stratevi
Alexandra Ellis - Collaborator - Stratevi
David Wingfield - Collaborator - HAMMERSMITH & FULHAM PARTNERSHIP PCN
Mari Thomas - Collaborator - University College Hospital
Mihail Samnaliev - Collaborator - Stratevi
Roy Arguello - Collaborator - StrateviOutcomes:
The key outcomes are rates of treatment discontinuation over time of newly diagnosed CAT patients with antithrombotic agents and rates of major bleeds within specified intervals of the index thrombosis event. Secondary outcomes include rates of CAT re-occurrence and retreatment, as well as healthcare utilisation and costs.
Description: Lay Summary
People with cancer are at a high risk of developing a blood clot that forms in the body. This risk is even higher among the elderly and those with certain types of cancer such as gastrointestinal cancer. Even with the best existing treatments, people with cancer who have previously experienced blood clots are at a higher risk of developing another blood clot, compared to people without cancer.
Anticoagulants, also known as âblood thinnersâ, are medicines that treat or prevent blood clots from forming. However, these medicines also increase the risk of bleeding. The concerns of patients and physicians about this increased risk of bleeding is a common reason why many patients with cancer do not receive enough of the anticoagulant treatment or do not receive any treatment at all. Lack of tolerability and difficulty swallowing an oral medication, leading to poor adherence, are other causes that contribute to undertreatment. In addition, some treatments may negatively interact with anti-cancer drugs.
The purpose of this study is to learn more about how cancer patients with blood clots are treated in the real world, and about the outcomes of their treatment. The study has important public health benefits in that it will generate key evidence of the unmet need in these patients, which may be addressed with new policies, clinical guidelines, and therapies in development. This is expected to ultimately improve the quality of care and outcomes for cancer patients with blood clots.
Technical SummaryCancer-associated thrombosis (CAT), particularly venous thromboembolism (VTE), is a significant cause of morbidity and mortality in oncology patients. Whilst using antithrombotic agents for VTE treatment reduces the risk of VTE recurrence, the risk of haemorrhage is increased especially in the elderly and acutely ill patients. We propose to undertake a retrospective study using linked CPRD-Aurum and Hospital Episode Statistics (HES) datasets to understand the real-world treatment gap and the long- and short-term health outcomes in CAT patients. Specifically, we will assess rates of treatment discontinuation among newly diagnosed CAT patients and will compare the demographic, clinical characteristics, and clinical and economic outcomes of those who are treated for adequate duration (â¥3 months) vs. undertreated (i.e., discontinued treatment before 3 months) or untreated.
The studyâs main outcomes will be rates of major bleeds after the first observed thrombosis event. Secondary outcomes will include (i) rates of CAT recurrence after the first observed thrombosis, (ii) percentage of patients with evidence of re-treatment (for the treated and undertreated groups) and (iii) healthcare utilisation and costs to the National Health Service (NHS). Statistical comparisons among the above groups will be based on the Student t-test or Mann-Whitney test for continuous variables and chi-squared or Fisherâs exact test for categorical variables. Time-to-event analyses (time to major bleeds, CAT recurrence and re-treatment) will be performed using the Kaplan-Meier method and treatment groups will be compared using the log-rank test. A conventional alpha of 0.05 and a two-tailed level of significance will be used. All analyses will be performed using SAS ® or R statistical software.
This study will generate important evidence on the extent to which practice guidelines are being followed in real-world settings and may identify opportunities to improve the quality and outcomes of care in these patients across England and Wales.
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Incidence and prevalence of Parkinson's: secular and demographic patterns — Donald Grosset ...
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Incidence and prevalence of Parkinson's: secular and demographic patterns
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-14
Organisations:
Donald Grosset - Chief Investigator - Parkinson's UK
Donald Grosset - Corresponding Applicant - Parkinson's UK
Cathal Doyle - Collaborator - Parkinson's UK
Katherine Grosset - Collaborator - Parkinson's UK
Lance Lee - Collaborator - Parkinson's UK
Prasanth Anand Iruthayaraj - Collaborator - Parkinson's UK
Romel Gravesande - Collaborator - Parkinson's UK
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes:
Key variables: Diagnostic code for Parkinsonâs; Prescription of specific anti-Parkinsonâs drug therapy; Index of Multiple Deprivation Domains
Description: Lay Summary
The number of people living with Parkinsonâs disease (a progressive brain condition causing slow movements and tremor) is steadily increasing. This is partly because people are living longer, and Parkinsonâs becomes more common with increasing age. We last studied the CPRD database in 2015, when we calculated that around 137000 people in the UK had Parkinsonâs.
Technical Summary
We now plan to study the CPRD database again, to obtain up-to-date numbers. We will use more detailed methods to be more accurate. We will the count of the numbers of people with a diagnosis of Parkinsonâs in GP records (which is what we examined in 2015). We will also count cases of Parkinsonâs recorded in hospital admissions. This will correct for errors when Parkinsonâs has been missed out of GP records.
We will use this information to examine several different factors that may be causing the increased numbers of people with Parkinsonâs. We will look at known factors: age, gender (men are twice as likely to get Parkinsonâs as women) and ethnicity (Parkinsonâs is more common in certain ethnic groups). We will also examine other factors, for which there is limited evidence in previous studies: whether living in rural areas increases the risk of Parkinsonâs compared to urban areas; and whether Parkinsonâs is related to levels of poverty. Learning about these factors will increase our understanding about the causes of Parkinsonâs.
Knowing up-to-date and more accurate numbers of people with Parkinsonâs will help planning for healthcare and social services.We aim to update the estimates of the incidence and prevalence of Parkinsonâs in the UK, derived from a combination of diagnostic coding of Parkinsonâs and the use of anti-Parkinsonâs drug therapy. Prevalence and incidence rates will be expressed as the numbers per 100,000 person years, using 5-year time bands above 20 years old. 95% confidence intervals. Estimates of numbers of people living with Parkinsonâs in the UK, 4 nations, and large regions of England, will be calculated by applying the prevalence rates from CPRD adjusted for age and sex/gender distribution from UK census data from the Office for National Statistics. The relationship between socioeconomic status and the prevalence and incidence of Parkinsonâs will be examined. Secular trends in the incidence and prevalence will derived to see if there is evidence of an increase after accounting for changes in the population structure. Secular trends in case fatality will be used to test whether increase in prevalence is partially explained by greater life expectancy. Findings will be used to support our policy and campaigns work relating to service provision for people with Parkinsonâs.
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Risks factors and causes of postnatal General Practitioner consultations and hospital admissions following perinatal mortality: a cohort study — Pensee Wu ...
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Risks factors and causes of postnatal General Practitioner consultations and hospital admissions following perinatal mortality: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-27
Organisations:
Pensee Wu - Chief Investigator - Keele University
Pensee Wu - Corresponding Applicant - Keele University
Carolyn Chew-Graham - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Muhammad Usman - Collaborator - Keele UniversityOutcomes:
1. GP consultations within 12 months of perinatal mortality; Number of consultations; Causes for consultation e.g., hypertension, mental health (including depression, anxiety, and post-traumatic stress disorder),
including prescriptions for these conditions2. Hospital admissions within 12 months of perinatal mortality; Number of admissions; Causes of admissions e.g., puerperal infection, bleeding, hypertension, depression
Description: Lay Summary
The loss of a baby is one of the most devastating life events that parents can face. There is, however, limited evidence of the impact of perinatal mortality (stillbirth and death of the baby within 28 days of being born) on the health of parents. We aim to use data from general practice records within CPRD Aurum and the linked hospital admission records to find out how often women go and see their doctor and are admitted to hospital within 12 months of perinatal deaths, and the reasons for these consultations and admissions (for example, whether they are related to their pregnancy or mental health). We will determine whether the number of consultations and admissions vary by factors like the geographical region where the woman lives or the extent of deprivation in their local area. We will find out what the key factors are which increase the risk of having more consultations and admissions, investigating factors such as age, deprivation, geographical region, existing other illnesses such as diabetes and depression, and previous pregnancies. The new knowledge from this research will be used to understand gaps in care following perinatal deaths and inform the development and design of new interventions and health policy. These, in turn, should improve the physical and mental health of women and families following perinatal deaths across the nation.
Technical SummaryThere is limited evidence of the impact on a motherâs health and care of perinatal mortality, defined as stillbirths and neonatal deaths (death within 28 days of life). The proposed research aims to determine the frequency and reasons for consultations to primary care, and of hospital admissions within 12 months of perinatal mortality using CPRD Aurum linked to HES Admitted Patient Care records. The study population will be women aged 11-49 with perinatal mortality recorded in their records between 1997 and 2020. We will include all consultations and admissions as outcomes but also focus specifically on pregnancy-related, hypertension, and mental health reasons for consultation and admission. We will determine geographical variation and factors which increase the risk of consultation and admission including socio-demographics (such as age, deprivation), index year, comorbidities (including anaemia, diabetes, hypertension, asthma, anxiety, depression) and prior pregnancy history. Cox proportional hazards models will be used to identify associations between the baseline potential risk factors and time to event (GP consultation and hospital admission), and negative binomial regression will be used to determine associations with number of consultations. The outputs from the proposed research will extend the current evidence-base and inform new interventions and service provision strategies, and ultimately help to improve the physical and mental health of women and families following perinatal mortality across the nation.
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The rate of measurement of creatinine and estimated glomerular filtration rate (eGFR) in people with and without gout and chronic kidney disease (CKD) in the Clinical Practice Research Datalink: a feasibility study — Richard Partington ...
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The rate of measurement of creatinine and estimated glomerular filtration rate (eGFR) in people with and without gout and chronic kidney disease (CKD) in the Clinical Practice Research Datalink: a feasibility study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-29
Organisations:
Richard Partington - Chief Investigator - Keele University
Sara Muller - Corresponding Applicant - Keele University
Abhishek Abhishek - Collaborator - University of Nottingham
Christian Mallen - Collaborator - Keele University
Edward Roddy - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Mark Lambie - Collaborator - Keele UniversityOutcomes:
eGFR (recorded or calculated from creatinine)
Description: Lay Summary
Gout affects approximately 1 in 40 people and causes sudden and severe joint pain and swelling. These âflaresâ most commonly affect the big toe. Flares are usually treated with medicines that reduce pain and swelling such as âanti-inflammatoriesâ, colchicine, or steroid tablets. People with gout are also more likely to have kidney problems.
Technical Summary
It is recommended that doctors weigh up the risks and benefits before deciding which drug to use in people with kidney problems who are having a gout flare. However, the guidelines donât rule out any of the treatment options.
We want to design a study looking at whether giving people with kidney problems anti-inflammatories to treat a gout flare makes their kidney problems worse. If we found they did not, patients would benefit as more treatment choices would be available to them.
How well a personâs kidneys are working is measured using kidney function test. To plan our new study, we need to know how often this test is recorded in the medical notes of people with and without gout and with and without pre-existing kidney problems.
This study will use CPRD to look at the number of times kidney function is recorded in people:
- with gout but without kidney problems
- without gout but with kidney problems
- with both gout and kidney problems
- without either gout or kidney problems
We will look at this over all the time in their medical record and immediately before and after gout flares diagnosed in primary care.Background
Gout is the most common inflammatory arthritis affecting 2.5% of UK adults. Acute flares cause significant pain and impaired quality of life.
Flares require rapid treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine or corticosteroids. NSAIDs cause significant potential adverse events, accounting for 30% of adverse drug reaction-related hospital admissions.
Gout is associated with comorbid conditions, including chronic kidney disease (CKD). CKD is categorised using estimated glomerular filtration rates (eGFR), calculated from the creatinine value. Gout guidelines highlight potential nephrotoxicity of NSAIDs and advise taking CKD into account before prescribing NSAIDs, but do not explicitly contra-indicate their use.Aim
To perform a feasibility study into rates of recording of eGFR (or creatinine) in people with and without gout and with and without CKD in preparation for a larger study about NSAIDs in people with gout.Objectives
Assess the rate of eGFR (or creatinine) measurements per year in four patient groups:
with gout and no history of CKD
without gout, but with a history of CKD
with gout and a history of CKD
without either gout or a history of CKD
Assess whether this rate increases in the 3 months before/after a gout flare.Methods
Four cohorts in CPRD Aurum, aged 18+ years with gout and/or CKD and a random sample of people with neither condition. Proportions and rates of individuals with recorded eGFR/creatinine measurements will be calculated in each of the 4 cohorts overall, in sociodemographic subgroups and in the periods immediately before/after a gout flare.Primary care data will be linked to indices of multiple deprivation to allow investigation of differential eGFR/creatine recording by deprivation.
This study will inform a larger study that aims to inform better guidance for the treatment of gout, in relation to kidney health.
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Comparing Direct Oral Anticoagulants to Vitamin K Antagonists on bleeding and cardiovascular outcomes in patients with atrial fibrillation: effect of using a common protocol only versus a syntactically harmonized Common Data Model — Olaf Klungel ...
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Comparing Direct Oral Anticoagulants to Vitamin K Antagonists on bleeding and cardiovascular outcomes in patients with atrial fibrillation: effect of using a common protocol only versus a syntactically harmonized Common Data Model
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-28
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Helga Gardarsdottir - Collaborator - Utrecht University
Marloes Bazelier - Collaborator - Utrecht University
Nicholas Hunt - Collaborator - Utrecht UniversityOutcomes:
Risk of stroke (haemorrhagic, ischaemic, or unclassified but not transient ischaemic attack), major bleeding (defined in line with previous studies within our group and based on the International Society on Thrombosis and Haemostasis definition as a symptomatic bleeding in an organ or other critical area), cardiovascular disease (acute myocardial infarction, stroke, acute coronary syndrome, other ischemic heart disease), glaucoma and hip fracture. See code lists in the appendix.
Description: Lay Summary
The use of electronic health records from several countries in the assessment of drug safety and effectiveness can provide us with more data across different populations allowing us to make more robust assessments. This allows researchers to compare the effects of drugs between countries, regions and healthcare systems; investigate specific groups of patients or identify rarer side-effects. However, such studies have several additional complexities, because recording and storage of patient information might be different in different data sources, making comparisons and overall assessments more challenging. There are several methods to address these differences which include a) the use of a single, but common protocol that can be followed and b) restructuring all databases into a single standard format, known as a common data model.
Technical Summary
We will compare these differences using the electronic healthcare records of two European countries, the United Kingdom (using CPRD GOLD) and the Netherlands (PHARMO Database Network). We will measure the risk of several clinical events (stroke, major bleeding, cardiovascular disease and glaucoma) after the use of drugs used to prevent blood clots in patients with atrial fibrillation, a condition where parts of the heart are out of sync. We will carry out the case study in the two countries twice with two methods method to combat database differences to see if there are differences in the results: one which uses only a common protocol and a one which uses a well implemented European common data model.In the last years many studies assessed whether the risk of major bleeding events among users of Direct Oral Anticoagulants (DOACs) is different compared to use of Vitamin K Antagonists (VKAs). In this project among patients with non-valvular atrial fibrillation we will also measure and compare the risk of stroke, major bleeding, cardiovascular disease, glaucoma and hip fractures following use of DOACs/VKAs. Incidence rates of outcome events and Cox proportional hazards analysis will be used to calculate hazard ratios (HRs) in the United Kingdom (as well as in the Netherlands). The other objective is methodological and addresses the impact of using different data harmonisation methods. Nowadays, use of multiple health databases is a preferred method for generating evidence on the safety and effectiveness of licensed medicines. This allows researchers to compare drug safety and effectiveness between countries, regions and healthcare systems; investigate specific groups of patients or identify rarer outcomes. However, these larger studies have an additional number of complexities. In part, these are due heterogeneity amongst data sources, a challenge only amplified when using multiple internationally distributed databases. Harmonisation methods such as the use of a common protocol (CP) and/or common data model (CDM) can mitigate bias and improve precision. A CDM can broadly be characterised as either developed in accordance with a protocol to fit study-specific data (i.e. a study specific CDM) or prior to a specific research protocol (i.e. a general CDM). In this study, we will focus on comparing the effect estimates and baseline characteristics when using the ConcePTION CDM, a syntactically harmonising CDM filled with study-specific data and a common protocol only approach that does not change the original data. Better understanding of such harmonisation methods will guide the selection/interpretation of epidemiological methods, allowing for more transparent and informed studies, thereby indirectly improving patient care.
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Cancer in people presenting with back pain in primary care (CanBack): a prevalence and diagnostic accuracy study — Pradeep Virdee ...
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Cancer in people presenting with back pain in primary care (CanBack): a prevalence and diagnostic accuracy study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-29
Organisations:
Pradeep Virdee - Chief Investigator - University of Oxford
Aron Downie - Corresponding Applicant - Macquarie University
Arianne Verhagen - Collaborator - Not from an Organisation
Brian Nicholson - Collaborator - University of Oxford
Christopher Maher - Collaborator - University Of Sydney
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Gustavo Machado - Collaborator - University Of Sydney
Hazel Jenkins - Collaborator - Macquarie University
Margaret Smith - Collaborator - University of Oxford
Mark Hancock - Collaborator - Macquarie University
Michael Swain - Collaborator - Macquarie University
Peter Stubbs - Collaborator - University of Technology Sydney
Richard Hobbs - Collaborator - University of Oxford
Simon French - Collaborator - Macquarie University
Subhashisa Swain - Collaborator - University of OxfordOutcomes:
Prevalence of back pain (Aim 1.1); diagnosis of cancer within the following 12 months (all other Aims).
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Description: Lay Summary
Back pain affects people of all ages and is a common reason to consult a GP. Most back pain can be managed by education, reassurance, analgesic medicines, or other therapies. Occasionally, back pain may be a symptom of undiagnosed cancer. Research shows that 1 in 200 people who consult their GP with a new episode of back pain have undiagnosed cancer. GPs must therefore decide if a patient can be managed conservatively or needs further investigation for cancer, as early detection can lead to improved outcomes. We seek to discover new ways to assist GPs in this decision-making process.
Our study will use anonymised patient records to collect information from the clinical consultation for a new episode of back pain over 22 years (2000 â 2022). We will work out the chances of having a diagnosis of cancer over the following 1 year. This will allow us to:
a) improve our understanding of back pain presenting to general practice,
b) estimate what proportion of people with back pain have a diagnosis of cancer within the following year,
c) discover to what amount additional clinical features from the patientâs history and examination indicate cancer â for example fever, pain at rest, unexpected weight loss, or a past history of cancer.The results of our research will improve guidance for GPs when performing the initial assessment of people with back pain.
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Technical SummaryThe objective is to inform strategies to screen for cancer in patients (⥠18 years) who present to primary care with back pain within the CPRD network of general practice registered between January 1st 2000 and December 31st 2022.
Aims
1. What is the association between a new episode of back pain presenting to primary care and cancer diagnosis?
2. In people with a new episode of back pain, what is the diagnostic utility of including clinical features from patient profile, history and physical examination to detect cancer within the following 12 months?Methods
A cohort analysis of the CPRD 2000 â 2022 will be undertaken to 1) Describe how often people present with a new episode of back pain and of these, have cancer diagnosis within the following 12 months; and 2) Calculate the diagnostic predictive value of additional clinical features for cancer. Cancer diagnoses will be obtained from the NCRAS, HES, and ONS (if related to death). Cox modelling will be used to assess the association between back pain and other clinical features with a subsequent diagnosis of cancer within 12 months. Adjusted measures of association will be calculated by including co-variates from the patient profile including age, sex, ethnicity, deprivation, and comorbidity. A 12-month cancer-risk prediction model in patients with back pain will be developed using clinically relevant covariates and covariates with high predictive ability. Performance will be evaluated using diagnostic accuracy measures including sensitivity, specificity, positive and negative predictive values. Measures of overall performance will include area under the receiver operating characteristic curve, D-statistic, Brier score, R-squared, calibration slope, and calibration plots.The screening model will inform the creation of clinical decision rules to help GPs decide if a new episode of back pain can be managed conservatively or requires referral for cancer investigation.
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Benefits and risks of pausing long-term osteoporosis treatment: nested case-control and cohort studies using data from the Clinical Practice Research Datalink. — Abhishek Abhishek ...
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Benefits and risks of pausing long-term osteoporosis treatment: nested case-control and cohort studies using data from the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-15
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Georgina Nakafero - Corresponding Applicant - University of Nottingham
Sara Muller - Collaborator - Keele University
Tricia McKeever - Collaborator - University of Nottingham
Victoria Welsh - Collaborator - Keele University
Zoe Paskins - Collaborator - Keele UniversityOutcomes:
Work-package-1: Nested case-control study.
Primary outcomes: Osteoporotic fracture after completing at-least three years (study-1) and at-least five years (study-2) of bisphosphonate treatment.Osteoporotic fracture will be defined using a comprehensive list of fractures with their primary-care medical code (for CPRD) and ICD-10 terms and codes (for HES and ONS). For Snomed codes, this will include diagnostic codes (e.g. Fracture of thoracic vertebra) and procedure codes (e.g. Vertebroplasty of fracture of spine). Procedure codes will be used to identify the occurrence of a fracture in the absence of a diagnostic code for fracture.
The list will include an inventory of fragility fractures. As it is very difficult to determine the mechanism of fracture from the patientsâ clinical records, as customary in epidemiological studies, osteoporotic fractures will be defined by the anatomical sites that are generally affected. Consistent with current definitions and previous studies [27, 28], major osteoporotic fractures will include those at hip, wrist, vertebra, and shoulder. Atypical femoral (sub-trochanteric) fractures will be excluded from this outcome.
Work-package-2: Outcomes: Atypical femoral fracture, osteonecrosis of jaw. They will be ascertained using ICD-10 codes and primary-care medical codes.
Description: Lay Summary
Approximately 2 million women in the UK have osteoporosis also called brittle bone disease. It causes painful and often life-threatening fractures after minor injuries such as falling while walking. Medicines like bisphosphonates make bones stronger and prevent fractures. However, their prolonged use prevents bone healing e.g. after dental surgery and causes bones to stiffen up and break on their own. Such breaks mostly occur in the thigh. To prevent these side-effects, treatment is often interrupted for 1-2 years after initial treatment for several years. However, such drug holidays can themselves cause fractures due to osteoporosis.
This study will examine the relation between osteoporotic fracture and preceding duration of pause in bisphosphonate prescription after an initial course of treatment for three and five years respectively. It will also explore the rate of thigh bone fracture and poor healing of jawbone after dental surgery during long-term bisphosphonate treatment.
Anonymised data originated from the NHS will be used. Data will be obtained from primary-care, hospitalisation, and death records. The effect of having a fracture with a one-year, two-years, or longer pause in bisphosphonate treatment after an initial treatment for three and five years will be calculated compared to continued treatment. Next, people treated with bisphosphonates for three or five years will be followed up electronically to find out the rate of thigh-bone fracture or poor healing after dental surgery.
These findings will aid shared decision making between patients and health professionals about duration of drug holiday after the initial treatment with bisphosphonates.
Technical SummaryBackground: Osteoporosis causes low-trauma fractures and is mostly treated with bisphosphonates. They suppress bone-turnover, increase bone mineral density, and prevent osteoporotic fractures. However, long-term suppression of bone-turnover is associated with atypical femoral fractures and jaw osteonecrosis. Pausing treatment can be associated with increased risk of osteoporotic fractures. There is conflicting guidance on the duration of initial bisphosphonate treatment and the length of the following treatment pause to minimise these risks.
Objectives:
Work-package-1: To examine the association between osteoporotic fractures and preceding duration of interruption in bisphosphonate prescription, after initial treatment for three-years and five-years respectively, compared to continued treatment.Work-package-2: To examine the incidence of atypical femoral fractures and osteonecrosis of jaw after three-years and five-years of bisphosphonate treatment.
Methods: Data from the Clinical Practice Research Datalink (CPRD) Aurum linked to hospitalisation and mortality records will be used. The study will span from 01-Jan-2007 to 31-Dec-2022.
Work-package-1: Separate cohorts of patients aged â¥18 years, prescribed bisphosphonate for â¥3-years and â¥5-years will be ascertained and followed-up to the occurrence of osteoporotic fracture or being censored. Cases will be participants that experienced an osteoporotic fracture after completing at-least three years (study-1) and at-least five years (study-2) of bisphosphonate treatment. Four contemporaneous age and sex matched controls from the cohort without an osteoporotic fracture will be selected using risk-set matching. Participants will be defined as having had or not had a treatment pause in each of the preceding 12-months before the index date. Multivariable conditional logistic regression will be used to assess the association.
Work-package-2: The cohorts in work-package-1 will be followed-up from after three or five years of bisphosphonate prescription to the earliest of osteonecrosis of the jaw, atypical femoral fracture, drug-discontinuation, death, date of last data collection or study end. The incidence (95% confidence interval) of each outcome will be calculated.
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Investigating the impact of SARS-CoV-2 on gastrointestinal illness using advanced linked data systems — Daniel Hungerford ...
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Investigating the impact of SARS-CoV-2 on gastrointestinal illness using advanced linked data systems
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-20
Organisations:
Daniel Hungerford - Chief Investigator - University of Liverpool
Michael Hawkings - Corresponding Applicant - University of Liverpool
Alex Elliot - Collaborator - UK Health Security Agency (UKHSA)
DIMITRIOS CHARALAMPOPOULOS - Collaborator - University of Liverpool
Iain Buchan - Collaborator - University of Liverpool
Liam Brierley - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
Primary care consultations for AGE.
Hospitalisations for AGE.
Primary care and hospitalisation with a diagnosis of IBD.
Primary care and hospitalisation with a diagnosis of CD.
Primary care and hospitalisation with a diagnosis of IBS.
HES Accident & Emergency attendances for gastrointestinal complaints.Description: Lay Summary
COVID-19 is a complex illness which can cause a wide range of symptoms. We know that around one in five people with COVID-19 will experience stomach & bowel issues such as diarrhoea. We also know that the virus that causes COVID-19 can negatively affect our bowel health. Currently, there are thought to be millions of people suffering from persistent symptoms after having COVID-19. There is some evidence to suggest that people suffering from âlong-COVIDâ may have symptoms like diarrhoea, and that some individuals may be more prone to developing illnesses that affect our bowel after having COVID-19.
Research investigating the long-lasting impact of COVID-19 on our bowel health is relatively weak, so we canât currently say who might be affected. Our study aims to investigate the relationship between a positive COVID-19 test and patients seeking care for stomach & bowel complaints. We are asking the question, do people infected with COVID-19 have an increased risk of stomach bugs and longer-term bowel problems?
We will use anonymised routine healthcare records from patients in the UK. We will look for GP consultations and hospital records for symptoms like diarrhoea, and for conditions like gastroenteritis (âa stomach bugâ). We will also look at diagnoses in a patientâs medical record for illnesses such as irritable bowel syndrome, inflammatory bowel disease and coeliac disease. Our study may show whether bowel issues are more common in individuals who have previously had COVID-19, whether vaccination affects this risk, and support researchers in developing future treatments.
Technical SummaryTo investigate the impact of SARS-CoV-2 infection on healthcare attendances for gastrointestinal symptoms and the incidence of acute gastroenteritis (AGE), gastrointestinal infections, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) and coeliac disease (CD) in the general population.
Objectives:
To assess whether SARS-CoV-2 infection:
1. has any impact on the rates of AGE;
2. is associated with autoimmune mediated gastrointestinal illness;
3. is associated with functional gastrointestinal illness.Design: cohort study and interrupted time series analysis.
Population: any age, from March 2020 (January 2015 for interrupted time series analysis).
Exposure: SARS-CoV-2.
Primary outcomes: CPRD recorded primary care consultations for AGE and gastrointestinal infections; Hospital Episode Statistic recorded hospitalisation with AGE; Primary care and hospitalisations with a diagnosis of: irritable bowel syndrome, inflammatory bowel disease and coeliac disease diagnoses.
Confounders and adjusters: comorbidity, antimicrobial prescribing, SARS-CoV-2 vaccination status, socioeconomic deprivation, ethnicity, geography.
Data analysis: our cohort will comprise participants reporting a SARS-CoV-2 RT-PCR result during the study period. Test-positive and test-negative participants will be enrolled in the cohort from March 2020. A time-to-event analysis will be conducted using Cox proportional hazards models and flexible parametric survival models to estimate hazard ratios for incident gastrointestinal outcomes.
Interrupted time series analysis of incident IBD and CD cases will be conducted for the period March 2020 to December 2023, and the pre-COVID period of January 2015 to February 2020. A synthetic control cohort will be constructed to account for changes in healthcare-seeking behaviour throughout the pandemic.
This study may demonstrate acute and chronic gastrointestinal illness and autoimmune illness as sequalae to SARS-CoV-2 infection. It could also provide evidence supporting pubic health behaviours around preventing respiratory infections and SARS-CoV-2 vaccination. The results may also support the development of clinical guidelines and potential treatments for such illnesses.
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Characterization of Pregnancy Outcomes in Women with Generalized Pustular Psoriasis — Sophia Fleming ...
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Characterization of Pregnancy Outcomes in Women with Generalized Pustular Psoriasis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-28
Organisations:
Sophia Fleming - Chief Investigator - IQVIA Ltd ( UK )
Sumayya Mushtaq - Corresponding Applicant - IQVIA Ltd ( UK )
Christopher Lee - Collaborator - IQVIA Ltd ( UK )
Jess Ridsdale-Smith - Collaborator - IQVIA Ltd ( UK )
Niina-Maria Nissinen - Collaborator - IQVIA Finland Oy
Rownak Jahan Archie - Collaborator - IQVIA Solutions Sweden ABOutcomes:
The primary outcome of interest in this study will be pregnancy outcomes. These include complications or clinical conditions occurring during pregnancy as well as outcomes relating to delivery and birth. The clinical conditions occurring during pregnancy include conditions such as but not limited to, antenatal haemorrhage, ectopic pregnancy, erythroderma, gestational diabetes, Pregnancy-induced hypertension, complication occurring during labor and delivery, Infectious disease in mother complicating pregnancy or childbirth and pre-eclampsia. The outcomes relating to delivery and birth include outcomes such as live birth, miscarriage, stillbirth, caesarean section.
As secondary outcomes, this study will assess newborn outcomes identified at birth or during the neonatal period (i.e., during the first 28 days of life), where applicable. The newborn outcomes considered include fetus and newborn affected by maternal complications of pregnancy, fetus and newborn affected by complications of placenta, cord and membranes, birth weight, appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute and 5 minutes, gestational age, neonatal infection, and neonatal mortality. These newborn outcomes will be assessed through mother-baby linkage.
Description: Lay Summary
Generalized Pustular Psoriasis (GPP) is a chronic, rare, and severe skin disease, which presents as repeated occurrence of flares affecting the skin and internal organs. GPP flares are unpredictable, potentially life-threatening and can lead to death. GPP flares can occur during pregnancy or be caused by pregnancy. GPP can also impact the management of the other disease and treatment decisions.
Specific treatments and guidelines for the management of GPP are lacking globally. A new drug Spesolimab, was recently shown to be effective in treating GPP flares in clinical trials. The US Food and Drug Administration (FDA) has required patients exposed to spesolimab before or during pregnancy to be observed for side-effects . To understand the impact of spesolimab exposure in pregnant women with GPP, robust knowledge of pregnancy outcomes in females with GPP is needed. Currently, data and available published literature are limited and insufficient to support our understanding of the pregnancy outcomes of women with GPP. Hence, this study is designed to provide a comprehensive description of pregnancy outcomes in population of women with GPP and newborn outcomes in babies born to mothers with GPP, in routine clinical practice. The data generated in this study will support increased detection of side-effects for patients exposed to spesolimab before or during pregnancy.
Technical SummaryGeneralized Pustular Psoriasis (GPP) is a rare, severe, neutrophilic skin disease, associated with loss-of-function mutations in the interleukin-36 (IL-36) receptor antagonist gene and associated genes, which lead to overexpression of IL-36 cytokines. GPP is characterized by repeated occurrence of acute and unpredictable flares caused by systemic inflammation affecting the skin and internal organs, that can carry high morbidity, including hospitalization, and can lead to death. GPP flares can be induced or exacerbated by pregnancy.
GPP during pregnancy (i.e. impetigo herpetiformis), typically onsets in the third trimester, but the aetiology is uncertain. Women with GPP are at an increased risk of adverse pregnancy outcomes including intrauterine growth restriction, miscarriage, stillbirth and adverse fetal outcomes. However, data are limited regarding the pregnancy outcomes of women with GPP and newborn outcomes in babies born to women with GPP.
The overall aim is to evaluate the occurrence of pregnancy outcomes in the population of women diagnosed with GPP and newborn outcomes (identified at birth or during the neonatal period i.e. during the first 28 days of life) in babies born to women with GPP, globally.To describe the occurrence of pregnancy/newborn outcomes, descriptive statistics will be provided for the study population. The crude cumulative incidence will be calculated and will be presented with corresponding 95% confidence intervals (CIs) for each pregnancy/newborn outcome in each country included in this study.
The data will provide insights into the occurrence of pregnancy outcomes in women with GPP including the newborn outcomes, globally. As well as crucial insights into how patients with GPP can be managed and monitored in England and Wales to improve the pregnancy and newborn outcomes in this patient group. Furthermore, this data will increase the understanding of current unmet need in women with GPP, and indirectly inform public health policy.
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Incidence, prevalence, and characterisation of medicines with suggested drug shortages in Europe — Marta Pineda Moncusi ...
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Incidence, prevalence, and characterisation of medicines with suggested drug shortages in Europe
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-22
Organisations:
Marta Pineda Moncusi - Chief Investigator - University of Oxford
Theresa Burkard - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
The main outcomes of this study are:
> Incidence rates of the use of medicines with (suggested) shortages and their alternatives
> Period prevalence of the use of medicines with (suggested) shortages and their alternatives
> Characteristics of incident and prevalent users of medicines with (suggested) shortages, including but not limited to:
- Age
- Sex
- Duration of usage of the medicines of interest
- Potential indication for prescribing/dispensing the medicines of interest
- Dosage of the medicines of interestDescription: Lay Summary
Shortages of essential medicines can harm patients by increasing the risk of prescribing errors, side effects, or even death. To mitigate its impact, the European Medicine Agency (EMA) started monitoring medicine shortages that may affect more than one European Union country and have been reporting it into a public catalogue since 2016.
This study aims to describe prescribing by UK general practioners (GP) of medicines with (suggested) shortages, and their alternatives, between 2010-2023. We will examine how prescribing varies by healthcare setting, patient characteristics, and over time. We will also describe the characteristics of patients receiving a new or repeat prescription for these medicines, including the condition for which they are being treated, treatment duration, and dosage, as well as other underlying conditions.
This study is part of a project from the European Health Data Evidence Network (EHDEN), a network of data sources standardized to the Observational Medical Outcomes Partnership Common Data Model (OMOP-CDM). The same study will be conducted separately in each data source. The aim is to improve our understanding of drug shortages in routine health care delivery by showing trends over time as well as patient characteristics. The results will contribute to the European efforts to monitor use of critical medicines as part of the global fight against medicine shortage.
Technical SummaryAIM
To improve our understanding of drug shortages in routine health care delivery.OBJECTIVESâ¯
(1) To investigate the incidence and prevalence of use of medicines with (suggested) shortages and their alternatives.
(2) To describe the incident and prevalent patients of medicines with (suggested) shortages stratified by calendar year, in order to observe changes in patientâs profiles.METHODS
Data: CPRD GOLD and CPRD AURUM standardized to the Observational Medical Outcomes Partnership Common Data Model.
Exposure(s): medicines with (suggested) shortages, including those listed as ongoing in the European Medicine Agency shortages catalogue for â¥1 year, and their alternatives.
Participant(s): incident and prevalent users of medicines of interest.
Study period: 2010-2023
Analysis:
- Incidence rates and period prevalence of the use of medicines with (suggested) shortages and their alternatives by calendar year, age groups (<18, 18-64, 65+ years), sex and healthcare setting.
- Characterisation of incident and prevalent users of medicines with (suggested) shortages (including but not limited to duration of usage of the medicines of interest, the potential indication for prescribing/dispensing it, and dosage) by calendar year.PUBLIC HEALTH BENEFITS
This project will be used to improve our understanding of drug shortages in routine health care delivery by showing trends over time as well as patient characteristics. The results will contribute to the European efforts to monitor use of critical medicines as part of the global fight against medicine shortage.
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Monitoring the prescription in primary care of antibiotics for public health emergencies that may be at risk of shortages in the European Union — Daniel Prieto...
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Monitoring the prescription in primary care of antibiotics for public health emergencies that may be at risk of shortages in the European Union
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-20
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Marta Pineda Moncusi - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Kim López-Güell - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
The main outcomes of this study are the incidence rates of the use of the 11 medicines of interest.
As a secondary outcome, we will forecast the prescription rates for the subsequent 6 months using an ARIMA model.Description: Lay Summary
The extended mandate of European Medicine Agency (EMA) reinforcing the role of the Agency in crisis preparedness and management of medicinal products and medical devices became applicable on 1st March 2022. The EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during public health emergencies. Such shortages would make it difficult or impossible to meet the treatment needs of individual patients or populations.
The general research question of this study is: What are the monthly prescription rates of selected medicines of importance for public health emergencies over the last 10-years? To answer it, this study aims to (1) characterise the incidence of use of 11 antibiotics used for public health emergencies that are considered at risk of shortages in order to understand trends, cycles and seasonality in the use of those medicines; and (2) to forecast short-term (6-month) prescription rates of such medicines under assumed scenarios, which could help anticipate and prevent potential shortages, or manage them.
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the EMA to generate timely evidence from healthcare data sources from across Europe. The EMA requested the DARWIN EU Coordination Centre to routinely and repeatly conduct this study in several European data bases, including CPRD, over the course of the 5-year study.
Technical SummaryAIM
To know what are the monthly prescription rates of selected medicines of importance for public health emergencies over the last 10-years and forecast the following 6-months.OBJECTIVESâ¯
(1)To estimate monthly incidence rates of use (prescription) of the 11 selected medicines during the last 10-years of available data, stratified by age and sex.
(2)To conduct a time series modelling by fitting an ARIMA model to data generated in objective 1 for short-term (6-month) forecasting.
The European Medicine Agency requested the DARWIN EU Coordination Centre to routinely and repeatly conduct this study in several European data bases, including CPRD, over the course of the 5-year study.METHODS
Data: CPRD GOLD standardized to the Observational Medical Outcomes Partnership Common Data Model.
Exposure(s): Eleven antibiotics identified as potentially critical in public health emergencies.
Participant(s): incident users of antibiotics.
Study period: 10-year period from the most recent data available.
Analysis:
- Monthly incidence rates of the use of medicines of interest by calendar year, age groups (<18, 18-64, 65+ years) and sex.
- Fitting of the time series data generated in objective 1 into an Autoregressive Integrated Moving Average (ARIMA) model to then forecast prescription rates for the subsequent 6-months.PUBLIC HEALTH BENEFITS
CPRD data on prescriptions is based on primary care prescribed drugs, thus, the observed behaviour is likely to not capture nor represent its use in hospital/specialists, but rather show the impact of shortages in primary care. The European Union pharmaceutical law applyed to the UK until January 2021, except for Northern Ireland, which continues. This project will be used to improve our understanding of drug shortages in routine health care delivery by showing trends over time as well as to forecast short-term prescription rates of such medicines under assumed scenarios, which could help anticipate and prevent potential shortages, or manage them.
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Associations between sociodemographic and environmental factors and cardiovascular disease risk in the UK. — Jianhua Wu ...
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Associations between sociodemographic and environmental factors and cardiovascular disease risk in the UK.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-08
Organisations:
Jianhua Wu - Chief Investigator - Queen Mary University of London
Jack Brown - Corresponding Applicant - Queen Mary University of London
Harriet Larvin - Collaborator - Queen Mary University of London
Paris Baptiste - Collaborator - Queen Mary University of LondonOutcomes:
The primary outcome will be incidence of any CVD (such as coronary heart disease, stroke, peripheral arterial disease etc.) amongst our study population.
The secondary outcomes will be subsequent (post index CVD diagnosis) major cardiovascular outcomes (such as heart attack, stroke, and heart failure, etc), non-cardiovascular outcomes (such as pneumonia, renal failure, liver disease, cancer, and dementia, etc), all-cause and cause-specific mortality.
Description: Lay Summary
Cardiovascular disease (CVD) is an umbrella term used to categorise a range of diseases affecting the heart and blood vessels. The most common CVDs include atrial fibrillation (irregular heartbeat), heart attacks (blocked blood flow to the heart blocked), and heart failure (heart unable to pump blood). CVD accounts for around one-quarter of all deaths in the UK.
Many factors can increase the likelihood of developing CVD, including high blood pressure (hypertension), diabetes, high cholesterol, smoking and obesity. These ârisk factorsâ are often controllable and early interventions can greatly reduce the risk of developing CVD. Additionally, a range of demographic, social and environmental factors such as sex, ethnicity and pollution are known to increase the risk of CVD, usually through impacting one or more CVD risk factors. In the UK, research exploring social and environmental factors and their impact on CVD risk and CVD development is lacking. Understanding associations between social and environmental factors and CVD could help with the development of early interventions to reduce the risk of CVD.
This study will use primary care and hospital medical records to explore which and how demographic, social and environmental factors are linked to developing CVD across the UK. We will then explore whether taking these factors into account when predicting a patients likelihood of developing CVD in the next ten-years improves the accuracy of prediction. We will also explore whether artificial intelligence (AI) based models perform better than traditional statistical models in predicting a patients risk of CVD.
Technical SummaryCardiovascular disease (CVD) is a significant cause of mortality and morbidity, accounting for a quarter of all deaths in the UK. Traditional CVD risk models tend to utilise clinical measures and limited demographic information. However, systematic reviews of CVD determinants have recognised a need to take a more holistic view of what constitutes âCVD riskâ in prediction models. There is growing evidence on the impact of social and environmental factors and the risk of developing CVD.
There is limited research on how social and environmental determinants impact risk of CVD, in a UK context and how the addition of these factors benefits CVD risk prediction tools. Incorporating social and environmental determinants into CVD risk prediction models could be helpful to set nonmedical interventions and to lower the social inequities in health.
Utilising electronic health records linked to ONS data and deprivation measures. This study will:
1. Assess associations between demographic, social and environmental factors and CVD development.
We will assimilate findings from both Cox proportional hazard models and survival random forests analysis to identify social and neighbourhood determinants for CVD.
2. Explore whether CVD risk prediction models accounting for social and environmental factors perform better than currently used models (using traditional statistical and ML models).
Using traditional statistical models (i.e. Cox proportional hazards model), we will introduce the social and neighbourhood variables and compare performance to that of a comprehensive ML prediction model that we will develop (utilising algorithms such as neural networks, random forest, support vector machines etc.).
3. Investigate whether CVD clusters around specific social and environmental factors and whether clustering varies by type of CVD.
Using ML clustering techniques, we will explore whether the risk of developing CVD tends to cluster around specific social and environmental factors. We will then stratify by the five most common CVDs.
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Feasibility study of the occurrence of severe clinical events in steatotic liver disease — Tina Landsvig Berentzen ...
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Feasibility study of the occurrence of severe clinical events in steatotic liver disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Practice Level Index of Multiple Deprivation (Standard)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-07
Organisations:
Tina Landsvig Berentzen - Chief Investigator - Novo Nordisk A/S
Tina Landsvig Berentzen - Corresponding Applicant - Novo Nordisk A/S
Katrine Grau - Collaborator - Novo Nordisk A/S
Mads Jeppe Tarp-Johansen - Collaborator - Novo Nordisk A/S
Mette Skalshøi Kjær - Collaborator - Novo Nordisk A/S
Michelle Long - Collaborator - Novo Nordisk Denmark A/S
Sune Boris Nygård - Collaborator - Novo Nordisk A/S
Timothy Stone - Collaborator - Novo Nordisk A/SOutcomes:
Severe liver events defined as a composite endpoint of; liver mortality; hepatocellular carcinoma; liver transplant; chronic liver failure; liver cirrhosis; portal hypertension; jaundice; and decompensated liver events (ascites; transjugular intrahepatic portal shunt; hepatorenal syndrome; hepatic encephalopathy; gastro-oesophageal varices with/without bleeding). Components may also be investigated individually.
Severe cardiovascular events defined as a composite endpoint of; cardiovascular mortality; stroke; acute myocardial infarction; unstable angina; heart failure; coronary revascularisation. Components may also be investigated individually.
All-cause mortality
Description: Lay Summary
Steatotic liver disease (SLD) includes a set of diseases where fat, inflammation, and scar-tissue builds-up in the liver. SLD can lead to severe disease and death. No medical treatment is available for the most common forms of SLD, metabolic SLD and alcohol related SLD. Thus, there is a great need for new treatments that can help these patients.
The aim of this feasibility study is to understand more about the severe diseases and deaths seen in SLD. This knowledge will be used to use improve clinical trials where new treatments for SLD are tested.
In clinical practice, SLD is often diagnosed after findings from liver function tests and clinical evaluations. We will therefore define our SLD population as patients with alanine transaminase and platelets recorded in CPRD AURUM. These two tests are commonly used to measure liver function among general practitioners in England. We will add information on obesity, blood sugar, blood pressure, blood lipids, alcohol, and other liver diseases to classify SLD into metabolic SLD and alcohol related SLD.
In patients with the two liver function tests recorded, we will study the occurrence of severe liver disease, severe heart disease and deaths. The occurrence will also be studied in the metabolic SLD and the alcohol related SLD, and in different age and ethnicity groups.
The study results will help us to improve the clinical trials where new treatments for SLD are tested. Better trials increase the chance of finding a treatment for people with SLD.
Technical SummarySteatotic liver disease (SLD) includes a spectrum of liver diseases classified according to aetiology. Progression of SLD increases the risk of severe clinical outcomes and death. No pharmacotherapy is approved for the most common forms of SLD, metabolic SLD (MASLD) and alcohol related SLD (ALD), and there is a significant unmet need for treating these conditions. Regulatory authorities require outcomes trials for approval of new treatments in MASLD/ALD. The aim of this feasibility study is to gain insights about outcome-events in MASLD/ALD to inform planning/design of clinical trials where new treatments for MASLD/ALD are investigated.
Biopsy-confirmed liver fibrosis predicts clinical outcomes in SLD and is often mandated as inclusion-criteria in trials. Biopsies are not performed in routine clinical practice where SLD is often diagnosed after findings from liver function tests (aminotransferases, GGT, platelets) and clinical evaluations.
We will define our SLD-population as patients with alanine transaminase (ALT) and platelets recorded in CPRD AURUM, as these are commonly used to measure liver function among general practitioners in England. We will add information on metabolic risk factors (anthropometry, blood glucose/diabetes, blood pressure, cholesterols, lipids), alcohol consumption and other liver diseases (autoimmune/viral/biliary/drug-induced) to classify SLD into MASLD/ALD and use fibrosis-4-index as indicator of fibrosis.
In the SLD-population with ALT and platelets, we will investigate occurrence of liver events, CV events, and all-cause mortality by calculating incidence rates and Aalen-Johannsen cumulative incidences. Occurrence will also be investigated in MASLD/ALD subpopulations, according to fibrosis-4-index and factors as age, sex, ethnicity, and socio-demography.
Linkage is used to capture outcome-events (Hospital Episode Statistics/Office for National Statistics) and ethnicity/socio-demography (Practice/Patient Level Index of Multiple Deprivation data/CPRD AURUM Ethnicity Record).
The study will improve planning of new MASLD/ALD trials increasing the likelihood of finding treatments for people with MASLD/ALD, which improves healthcare for many patients with significant unmet needs.
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Measuring current practice and inequalities in type 2 diabetes treatment and intensification: a population-based cohort study — Patrick Muller ...
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Measuring current practice and inequalities in type 2 diabetes treatment and intensification: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-20
Organisations:
Patrick Muller - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Folashade Naku - Collaborator - National Institute for Health and Clinical Excellence - NICE
James Hawkins - Collaborator - National Institute for Health and Clinical Excellence - NICE
Jonathan Wray - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Frequency (count) of medicines prescribed for treatment of diabetes; Frequency (count) of medicines prescribed to prevent complications associated with diabetes; Uptake (proportion of patients) initiating first line treatment following diabetes diagnosis, Uptake (proportion of patients) initiating additional treatment (intensification); time to first line treatment; time to intensification; Prevalence of : angina, heart failure, myocardial infarction, stroke, amputation, end-stage kidney disease, retinopathy, ulceration; Demographic characteristics: age, duration of diabetes, ethnicity, gender, weight and height, BMI, IMD quintile; clinical risk factors: albuminuria, atrial fibrillation, peripheral arterial disease, smoking status, estimated glomerular filtration rate, haemoglobin, HbA1c, heart rate, high-density lipoprotein, low-density lipoprotein, systolic blood pressure, white blood cell count; QRISK scores.
Description: Lay Summary
This analysis will describe current practice in type 2 diabetes treatment in England, this is a common disease, where blood sugar is too high. We will select a group of patients with a diagnosis of diabetes in their primary care record, and describe this population by age, gender, ethnicity, and deprivation, as well as how many patients have specific other health conditions or have diagnosed diabetic complications.
We will describe how many people start treatment (uptake), which medications are prescribed first and which drugs are added to prevent complications associated with diabetes.
All the statistics will be produced separately for different groups of people with type 2 diabetes: patients with one of two additional heart conditions, with kidney disease, and with either a high or no additional risk of heart problems.
Results from this analysis will be entered into a health economic model. That model will simulate current practice in diabetes treatment. Treatment effect measures from published clinical trials will also be entered into the model and the potential impact of different treatment policies on patientsâ health and the corresponding costs to the health system will be estimated.
These results will by considered by the type 2 diabetes committee at the National Institute for Health and Care Excellence (NICE) to determine the most cost-effective treatment recommendations, while accounting for potential health inequalities in treatment uptake. The subsequent publication of a guideline update will likely have a considerable impact on patient care and benefit this patient population.
Technical SummaryNICE recommendations from 2022 for the management of Type 2 diabetes mellitus with pharmacological interventions are being updated to consider additional treatment benefits including for non-cardiovascular outcomes (including, blood glucose, amputation, end-stage renal disease, retinopathy, ulceration). The new guideline model will evaluate treatment effects on both cardiovascular and non-cardiovascular effects.
Descriptive data from CPRD will be entered into an economic model alongside estimates of treatment effects, costs and quality of life measures (from published sources such as systematic reviews and published clinical trials). CPRD primary care and linked hospital episode statistics admitted patient care (HES APC) data will be used to provide a real-world context to this guideline update. A cohort of patients with prevalent type 2 diabetes will be selected and we will describe:
1. Baseline demographic characteristics: ethnicity, gender, age, diabetes duration, weight, height, BMI
2. Percentages of patients who have historical records of eight diabetes-related complications (myocardial infarction, angina, stroke, heart failure, amputation, renal failure, diabetic ulcer and blindness in one eye) and additional clinical risk factors.
3. The most frequent treatment or treatment combinations for each population as a proxy for âstandard careâ in the model, and uptake (as a proportion) to the first-line and additional treatments by ethnicity and deprivation.Separate estimates will be generated patients in each of five defined strata: patients with heart failure; with atherosclerotic cardiovascular disease (CVD); with chronic kidney disease, with high CVD risk; without high CVD risk. Additionally, results will be stratified by ethnicity and Index of Multiple Deprivation (IMD) quintiles based on patient-level IMD index. Analyses will be descriptive with rates, frequency counts, means, proportions or similar measures presented as relevant. This work will benefit patients by supporting the update of NICE recommendations for the management of Type 2 Diabetes within the NHS.
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Trends in prescription of oral anticoagulants in elderly individuals with atrial fibrillation in UK primary care — Samy Suissa ...
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Trends in prescription of oral anticoagulants in elderly individuals with atrial fibrillation in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-28
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Corresponding Applicant - McGill University
Ekaterina Pazukhina - Collaborator - McGill University
Erica Moodie - Collaborator - McGill University
Sarah Beradid - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
First prescription of DOACs (apixaban, edoxaban, dabigatran, rivaroxaban) and VKAs in elderly patients with NVAF, overall and by age, sex, particular comorbidities, UK nations and individual OAC molecules.
Baseline characteristics of patients newly prescribed OAC (age, sex, comorbidities, comedications, measures of health utilization).
Predictors of initiation and persistence of OAC treatment
Prevalence of OAC utilization overall and by age, sex, UK nations and OAC molecules.Description: Lay Summary
Anticoagulants are medications that are used to reduce the formation of blood clots. They are often prescribed to patients with irregular heart rhythm such as atrial fibrillation to prevent strokes (blood clots in the brain). The most commonly used oral anticoagulants are vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs). Although effective at reducing the risk of clotting, VKAs are impractical to use, and may be associated with significant bleeding complications. DOACs were introduced in the UK in 2008 as potentially interesting alternatives to VKAs. They work as well as warfarin in reducing blood clots but cause fewer bleedings and are also easier to use. Atrial fibrillation is common in elderly patients and oral anticoagulants have been shown to be very effective to prevent stroke in this population. However, they are often underprescribed to these patients. It is not clear whether the recent introduction of DOACs has led to an increase in the number of elderly patients prescribed anticoagulants. Therefore, the objective of this study will be to describe temporal trends in the prescription of oral anticoagulants to patients with atrial fibrillation aged 80 and above between 2011 and 2021 in the UK. We will also describe the characteristics of patients who are treated with these medications. These findings will inform physicians and public decision makers on the use of oral anticoagulants over time in elderly patients.
Technical SummaryIndividuals with atrial fibrillation have a five-fold increased risk of ischaemic stroke compared to those without atrial fibrillation. Direct oral anticoagulants (DOACs) are recommended over vitamin K antagonists for most patients with nonvalvular atrial fibrillation (NVAF) for the prevention of stroke, including elderly patients. However, oral anticoagulants (OACs) are often under-prescribed to the elderly in clinical practice. A better understanding of the prescribing trends since the approval of DOACs for stroke prevention in NVAF in 2011 and obstacles to DOACs prescription in this population could help improve the management of these patients. Thus, we will conduct a cohort study to describe temporal trends in prescriptions of OACs in elderly patients in UK primary care between 2011 and 2021. The cohort will include all patients aged 80 years and older with NVAF registered in the CPRD during the study period. We will estimate incident rates of OAC prescriptions for each calendar year using a Poisson distribution, overall and stratified by age, sex, OAC molecule, and nation. We will also identify the predictors of OAC initiation and persistence. Finally, we will describe changes in baseline characteristics of elderly patients newly prescribed OACs over time. Given that OACs have been underprescribed in this elderly population, the results of this study will provide insight as to how OAC prescribing have evolved in UK primary care practices in the last decade.
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The effect of antiseizure medications on the effectiveness and safety of anticoagulants in patients with stroke: A population-based study in the United Kingdom. — Li Wei ...
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The effect of antiseizure medications on the effectiveness and safety of anticoagulants in patients with stroke: A population-based study in the United Kingdom.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-19
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Sohee Park - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Stella Kim - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )Outcomes:
Outcomes of interest are recurrent stroke, major adverse cardiovascular events (MACE) and bleeding after stroke.
Description: Lay Summary
Seizure is an important complication following stroke, known as a common cardiovascular disease that occurs when there is an interruption in the blood flow to the brain. About 10% of people with this cardiovascular condition develop seizures and these people require ongoing treatment with antiseizure medications to control and prevent seizures. However, current clinical guidelines suggest avoiding the use of antiseizure medications with blood-thinning medications known as anticoagulants. Despite this, there is limited evidence on how these two medications interact and affect health outcomes in people with stroke. This study will be using de-identified GP and hospital admission records in the UK to better understand how antiseizure medications might affect the effectiveness and safety of using anticoagulants among people who have had a stroke. The findings of this study will support healthcare providers and policy makers to make better decisions when it comes to treating seizures in people with stroke.
Technical SummaryThe aim of this study is to investigate the effect of antiseizure medication (ASM) on the effectiveness and safety of anticoagulants among people with stroke. A retrospective self-controlled case series study will be conducted using the UK Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) data. People who have been diagnosed with stroke between January 1, 2011 and December 31, 2020 will be identified using Read and SNOMED codes. Those who were prescribed with anticoagulant and ASM concurrently will be included. British National Formulary codes will be used to identify anticoagulant and ASM prescriptions. Outcomes of interest are recurrent stroke, major adverse cardiovascular events, and bleeding. ICD-10 diagnosis codes will be used to identify stroke-related outcomes from HES data. Conditional poison regression model will be used to estimate the incidence rate ratios by comparing incidence rates of recurrent stroke, MACE and bleeding between anticoagulant treatment period and combination treatment period in stroke patients. Subgroup analysis will be conducted by ASM regimen. Findings of this study could support healthcare providers and policy makers to make better decisions when treating seizure in stroke patients.
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD) — Stephen Privitera ...
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-01
Organisations:
Stephen Privitera - Chief Investigator - Bayer AG
Yik Ming Fung - Corresponding Applicant - Bayer AGOutcomes:
Incidence of stroke among patients with epilepsy
Description: Lay Summary
Over the last few years, organisations who make data available for public health research have been looking for ways to improve data sharing and security among users of the data. One approach that has been recommended in the UK is the use of platforms which allow access to data so analysis can be performed but limited outputs (e.g. aggregated results) can be exported. CPRD are working to establish such a platform for its users. However, it is key that the platform still enables vital health research to be performed. To help assess this, a study looking at epilepsy and stroke will be conducted.
Epilepsy is the name for a group of chronic conditions which result in repeated seizures and affects people of all ages, genders and ethnicities. Epilepsy has been linked to other conditions, including stroke. However, studies in this area have been limited and not recent.
The aims of this study are to provide more updated information on the statistics of stroke in epileptic patients while also assessing if important research can be conducted in CPRDâS secure platform. As there is a drive for more organisations to use such platforms, this research will benefit public health by ensuring such methods do not hamper research using CPRD data.
Technical SummaryThe main aim of this study is to calculate the incidence of stroke among patients with epilepsy who were prescribed anti-seizure medication. This research will benefit public health by presenting an updated picture of the disease in the UK thus highlighting areas of improvement in the management of such patients and suggesting areas for further research. Additionally, this study aims to test the use of CPRDâs secure platform to ensure it will enable data access and analysis for important health research.
This is a retrospective cohort study of epileptic patients prescribed anti-seizure medication with an incident record of stroke between 01/012010-31/12/2019 in their primary or secondary care data record.
The CPRD primary care data will be used for defining the study population. This will also be linked to the Hospital Episode Statistics Admitted Patient Care (HES APC) data (for defining the outcome of stroke), Office for National Statistics (ONS) Death Registration data (for defining the outcome of stroke and the date of death), and patient-level Index of Multiple Deprivation (IMD) data (as a covariate).
Descriptive results will be presented for patient demographics and incidence rates will also be calculated as the number of newly diagnosed stroke events in patients with epilepsy (numerator) divided by the sum of the person years of follow-up of epileptic patients during each calendar year of interest. The rates will be stratified by age group, gender, and year of stroke diagnosis.
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Comparing Direct Oral Anticoagulants to Vitamin K Antagonists on bleeding and cardiovascular outcomes: cohort study on the effect of using common data models — Olaf Klungel ...
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Comparing Direct Oral Anticoagulants to Vitamin K Antagonists on bleeding and cardiovascular outcomes: cohort study on the effect of using common data models
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-28
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Helga Gardarsdottir - Collaborator - Utrecht University
Marloes Bazelier - Collaborator - Utrecht University
Miriam Sturkenboom - Collaborator - University Medical Centre Utrecht
Nicholas Hunt - Collaborator - Utrecht UniversityOutcomes:
Risk of stroke (haemorrhagic, ischaemic, or unclassified but not transient ischaemic attack), major bleeding, cardiovascular disease (acute myocardial infarction, acute coronary syndrome, any stroke, other ischemic heart disease), glaucoma (as a negative outcome) and hip fractures (as a negative outcome).
In the exposure
Description: Lay Summary
In this methodological study, we will focus on patients with a heart condition called non-valvular atrial fibrillation who are taking blood-thinning drugs and calculate their risk of several acute events for those using direct oral anticoagulants (a novel type of blood thinning drug) vs. those using longer-existing Vitamin K antagonists. Although this has been studied before, including in CPRD, a new element is being added. Assessing whether drugs work in daily clinical practice and are safe is important from a public health perspective. To increase the number of people included in such safety studies, thereby increasing the power, nowadays often different data sources are used. This helps to look at specific groups of patients and find any rare side effects. However, there is a challenge as different data sources store medical data in different data formats. This can cause problems when we want to compare or combine data from different sources. There are several methods to deal with such differences, including methods that alter the original data into a standard format. Therefore, we will also compare the results we find when the study is performed under three different scenarios for handling data structure differences: one that sticks to a common study protocol (no changes made to the original data), one which adjust the original data to fit a common data format fine-tuned to the study protocol and one that changes the original data to a common data format independent of the study protocol.
Technical SummaryIn recent years many studies have addressed the question whether the risk of major bleeding events among users of Direct Oral Anticoagulants (DOACs) is different compared to use of traditional Vitamin K Antagonists (VKAs). In this project, we will focus on patients with a diagnosis of non-valvular atrial fibrillation and compare the risk of stroke, major bleeding, cardiovascular disease, glaucoma and hip fractures (the latter two are negative outcomes) after the use of DOACs or VKAs. Cox proportional hazards regression models will be used to calculate hazard ratios (HRs). An additional,methodological objective is to study the impact of using different data harmonisation methods. Nowadays, use of multiple health databases is a preferred method for generating evidence on the safety and effectiveness of licenced medicines, enabling researchers to compare drug safety and effectiveness between countries, regions and healthcare systems; investigate specific groups of patients or identify rarer outcomes. For these reasons, they are deemed essential by national and international regulators to assess the clinical effects of drugs. However, these larger studies have an additional number of complexities. In part, these are due heterogeneity amongst data sources, a challenge only amplified when using multiple internationally distributed databases. Harmonisation methods such as the use of a common protocol (CP) and/or common data model (CDM) can mitigate bias and improve precision. A CDM can broadly be characterised as either developed in accordance with a protocol to fit study-specific data (i.e. a study specific CDM) or prior to a specific research protocol (i.e. a general CDM). We will compare the estimates from cox proportional hazards regression models and descriptive statistics (incident rates) of the case study after the application of a study-specific CDM with syntactic harmonisation, a general-use CDM and the use of a common-protocol only.
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Does flucloxacillin increase the risk of stroke and systemic embolism in patients who are already using direct oral anticoagulants? — Shahab Abtahi ...
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Does flucloxacillin increase the risk of stroke and systemic embolism in patients who are already using direct oral anticoagulants?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-20
Organisations:
Shahab Abtahi - Chief Investigator - Utrecht University
Shahab Abtahi - Corresponding Applicant - Utrecht University
Anton Pottegård - Collaborator - University Of Southern Denmark
Ditte Bork Iversen - Collaborator - Utrecht University
Martin Ernst - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Tore Bjerregaard Stage - Collaborator - University Of Southern DenmarkOutcomes:
Occurrence of stroke or systemic embolism; bleeding.
Description: Lay Summary
Direct oral anticoagulants (DOACs) are a group of blood thinning agents. They are commonly used to lower the risk of stroke and blood clots in body. They were developed as alternatives to another blood-thinning agent, warfarin. DOACs are just as safe and effective as warfarin in prevention of stroke in patients with heart rhythm problems, and are more convenient than warfarin because routine blood tests are not required.
Technical Summary
Flucloxacillin is an antibiotic that is commonly used worldwide to treat infections in the skin and soft tissues and is typically used for 7-10 days. Previous studies have shown that flucloxacillin decreases the ideal effect of warfarin when they are used together, thus leading to an increased risk of stroke. Also, laboratory studies showed that flucloxacillin might have a similar effect on DOACs effectiveness in preventing strokes and blood clots. Thus in this study, we aim to investigate if the use of flucloxacillin and DOACs together increases the risk of strokes compared to use of another antibiotic and compared to no treatment with antibiotics.
The results of our study will help with safer use of flucloxacillin, especially in patients who are already receiving blood thinning agents.This study will examine the association between concomitant use of flucloxacillin and DOACs, and the risk of stroke and systemic embolism.
This will be a retrospective cohort study using the Clinical Practice Research Datalink (CPRD). All adults above 18 years old with a prescription of DOACs between 2011-2022 will be included.
The index date will be the prescription date of flucloxacillin. The primary exposure of interest in this study is use of flucloxacillin, while the primary outcome is a stroke or systemic embolism 5-20 days after prescription fill of flucloxacillin.
We will perform a propensity score matching to balance covariates at index date. Then cox proportional hazards models will be used to conduct statistical analysis.
The main analysis will compare the risk of stroke and systemic embolism among DOAC users taking flucloxacillin versus phenoxymethylpenicillin users and versus non-antibiotic users.
In the secondary analyses, we will perform the analysis on subgroups and conduct a self-controlled case-crossover study to account for confounders that are stable over time.
In the self-controlled case-crossover study, patients experiencing either a stroke or systemic embolism will work as their own control and contribute with data for both the exposed and unexposed follow-up time. The time for experiencing an outcome is defined as day 0, and day -5 to day -20 is defined as the focal window, which determines the reason for the outcome. We will also apply a wash-out-window of 15 days after the focal window and 4 reference windows, all having a length of 15 days.
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Incidence, Prevalence, and Predictors of Fibromyalgia in People with Inflammatory Arthritis: An Observational Cohort Study using the Clinical Practice Research Datalink Aurum. — Ian Scott ...
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Incidence, Prevalence, and Predictors of Fibromyalgia in People with Inflammatory Arthritis: An Observational Cohort Study using the Clinical Practice Research Datalink Aurum.
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-12-27
Organisations:
Ian Scott - Chief Investigator - Keele University
Kolawole Adeniran - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Richard Partington - Collaborator - Keele University
Sara Muller - Collaborator - Keele UniversityOutcomes:
SNOMED/Read code for a diagnosis of fibromyalgia.
Description: Lay Summary
Inflammatory arthritis includes several different conditions causing inflamed joints. The commonest types are ârheumatoid arthritisâ, âpsoriatic arthritisâ, and âaxial spondyloarthritisâ. It is common, affecting 1 in 100 people.
Persistent pain is common in people with inflammatory arthritis. Whilst it has many causes, previous studies have shown it is often related to the development of a condition called âfibromyalgiaâ. Fibromyalgia is thought to result from abnormal levels of certain chemicals in the bodyâs nerves. It changes how people experience pain and other sensations, leading to pain throughout the body, fatigue, and foggy thinking. Fibromyalgia affects 2 in 100 people but is estimated to affect up to 21 in 100 people with inflammatory arthritis.
Very few studies have looked at when fibromyalgia occurs in people with inflammatory arthritis or whether some people with inflammatory arthritis are more likely to develop it. Understanding this is important as knowing when fibromyalgia happens in people with inflammatory arthritis and who is most likely to develop it could allow timely treatment to be used to reduce its impacts on patientsâ lives. It could also support further research exploring why fibromyalgia is much commoner in people with inflammatory arthritis and whether it can be prevented.
Our study will investigate when and how often fibromyalgia occurs in people with inflammatory arthritis in the Clinical Practice Research Datalink Aurum database. It will also explore whether there are certain characteristics that people with inflammatory arthritis have when they are diagnosed with arthritis that make them more likely to develop fibromyalgia.
Technical SummaryFibromyalgia, a chronic condition characterised by widespread nociplastic pain alongside somatic, cognitive and mood symptoms, has been shown to affect approximately 1.8% of the general population. However, among people with inflammatory arthritis â an umbrella-term referring to conditions associated with inflammation of the joints and surrounding soft tissues â the prevalence is significantly higher with a recent meta-analysis reporting it to affect 21%, 18% and 13% of people with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthropathy, respectively. Fibromyalgia not only disproportionately affects people with inflammatory arthritis but has been shown to worsen disease outcomes and increase healthcare utilisation as well as result in higher levels of work-related disability.
Few longitudinal studies have examined when fibromyalgia occurs in people with inflammatory arthritis. These are limited by small sample sizes, short follow-up durations (with no study examining fibromyalgia incidence across the entire disease course), and a lack of information about how this varies across inflammatory arthritis subtypes and by socioeconomic factors such as age, gender, and deprivation. There is also little published information on prognostic factors that are associated with the subsequent development of fibromyalgia in people with inflammatory arthritis.
We will describe the annual incidence of fibromyalgia, its prevalence at various time points in the arthritis disease course and in different sociodemographic groups. Values will be presented as proportions with confidence intervals. We will examine prognostic factors for the subsequent development of fibromyalgia present at arthritis diagnosis using Kaplan-Meir plots with accompanying Cox proportional hazards regression models.
Our findings will provide valuable insight into when fibromyalgia occurs in people with inflammatory arthritis and which groups of people are most at risk of its development, supporting the design of healthcare approaches to reduce the impacts of pain from fibromyalgia in people with inflammatory arthritis and informing future research studies into its course.
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ID-378: Substance Misuse — London Borough of Hammersmith and Fulham...
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ID-378: Substance Misuse
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-23
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith and Fulham
Description: Substance use.
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ID-379: Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS) — University of Southampton...
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ID-379: Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling (FLOWS)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-23
Opt Outs: no information provided./p>
Organisations: University of Southampton
Description: Health and social care workforce organisation. Commercial
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ID-380: Dementia’s contribution to health and care metrics and associated costs — Parkbury House Surgery...
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ID-380: Dementia’s contribution to health and care metrics and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-23
Opt Outs: no information provided./p>
Organisations: Parkbury House Surgery
Description: Dementia.
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ID-381: Breaking New Ground: LA + Health CYP Data Sharing — Social Finance...
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ID-381: Breaking New Ground: LA + Health CYP Data Sharing
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-23
Opt Outs: no information provided./p>
Organisations: Social Finance
Description: CYP data sharing.
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ID-377: The Impact of Remote and In-Person Consultations on Health Outcomes in Type 2 Diabetes Patients — Imperial College London...
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ID-377: The Impact of Remote and In-Person Consultations on Health Outcomes in Type 2 Diabetes Patients
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Diabetes patients.
Source
2023 - 11
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Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of the Moderna Spikevax COVID-19 vaccine (Elasomeran (mRNA-1273)) — Debabrata Roy ...
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Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of the Moderna Spikevax COVID-19 vaccine (Elasomeran (mRNA-1273))
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-23
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Denise Morris - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Saad Shakir - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
Myocarditis and pericarditis cases will be confirmed based on adjudication criteria similar to the United States Centers for Disease Control and Prevention (CDC) case definition (1); âProbableâ and âDefiniteâ cases of myocarditis and pericarditis will be obtained using CPRD Aurum.
If feasible, subgroup analyses will examine cases with a severe clinical course or long-term sequelae. Severe outcomes of myocarditis/pericarditis that will be assessed include acute coronary syndrome, acute myocardial infarction, heart failure, atrial fibrillation/flutter, ventricular arrhythmias/cardiac arrest, pulmonary embolism or deep venous thrombosis, stroke outcomes, peripheral arterial embolism, hospital readmission (i.e., within 30 days of first hospitalisation), ICU admission or death.
Description: Lay Summary
Elasomeran (Spikevax) is an mRNA COVID-19 vaccine developed by Moderna that was approved for use in the UK on 8th January 2021. Cases of myocarditis and pericarditis (conditions characterised by inflammation of the muscle and lining of the heart) have been observed as side effects following vaccination with mRNA COVID-19 vaccines, including Elasomeran. Most of these cases are mild and have occurred within 14 days following vaccination, more often after the second dose and in younger men. Additional data are needed to describe the clinical course and long-term outcomes of these events and to characterise risk factors for both occurrence and severity.
This UK study is part of a group of studies in Europe using information from primary care electronic health records to provide this data. The aim of this study is to characterise the clinical course, outcomes, and risk factors for myocarditis and pericarditis following at least one dose of the Elasomeran vaccine. The study will assess risk factors, other than Elasomeran vaccination, for the development of myocarditis and pericarditis in Elasomeran recipients, to understand which characteristics increase or decrease the risk for the development of these conditions following Elasomeran vaccination. Additionally, the study will describe factors that predict a more severe course of myocarditis or pericarditis regardless of vaccination status. This will help with assessing the individuals who are at increased risk for severe disease as early as possible in order to provide appropriate care in a timely manner.
Technical SummaryElasomeran (Spikevax), developed by Moderna, is an mRNA-1273 vaccine approved for use in the UK on 8th January 2021. Since approval, cases of myocarditis and pericarditis have been observed following vaccination with mRNA vaccines targeting SARS-CoV-2, with most cases occurring within 14-days following vaccination, after the second dose and in younger men. Although most cases of vaccine-associated myocarditis and pericarditis have been described as mild, additional data are needed to describe the clinical course and long-term outcomes of these events and to characterise risk factors for occurrence and severity.
To further examine the risk of myocarditis and pericarditis with the Elasomeran vaccine, the Vaccine monitoring Collaboration for Europe (VAC4EU), on behalf of Moderna are conducting this study across electronic health records databases in four countries; this CPRD study will contribute UK data. This study aims to characterise the clinical course, outcomes, and risk factors for myocarditis and pericarditis associated with Elasomeran vaccination. The natural course of these conditions will be investigated in terms of morbidity, and relevant prognostic factors will be ascertained. An exposed case cohort design will investigate risk factors other than Elasomeran vaccination for the development of myocarditis and pericarditis in Elasomeran recipients, to provide an understanding of which characteristics influence the risk of these conditions following Elasomeran vaccination. A cohort study design will ascertain factors that predict more severe courses of myocarditis or pericarditis, regardless of vaccination status. This will help earlier recognition of individuals at higher risk for severe disease ensuring timely and effective care.
Data will be extracted from CPRD in 2023, 2024 and 2025 for two interim and one final report. Results from CPRD analyses will be pooled with aggregate results from European Data Access Providers using a Digital Research Environment. CPRD approval has been obtained for aggregation of results (Query Reference number 00077310).
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Association between COVID-19 and new onset of diabetes — Martà Català Sabaté ...
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Association between COVID-19 and new onset of diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-22
Organisations:
Martà Català Sabaté - Chief Investigator - University of Oxford
Pablo Spivakovsky Gonzalez - Corresponding Applicant - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Nicola Barclay - Collaborator - University of OxfordOutcomes:
A new onset diagnosis of T1D or T2D.
Description: Lay Summary
Diabetes is a serious illness that occurs when the body cannot regulate its blood sugar levels. Whilst it is commonly thought that a family history of diabetes is the most important risk factor, being exposed to viruses can also trigger this disease. This is because viruses trigger immune responses in the body, and in some cases, these immune responses can attack healthy cells in the body. In the case of diabetes, immune cells can attack the pancreas, the organ which manages the amount of sugar in the blood. This results in high blood sugar levels, which over time can lead to damage to the eyes, kidneys, nerves and blood vessels.
The recent SARS-CoV-2 (COVID-19) pandemic raised concerns about the possible development of post-COVID complications that may be triggered by the bodyâs immune response. One such concern is the development of new onset diabetes. Therefore, the aims of this study are to:
1. Evaluate the association between SARS-CoV-2 and new onset diabetes
2. Determine whether associations between SARS-CoV-2 and new onset diabetes are moderated by age and/or sexFinding associations between SARS-CoV-2 and new onset diabetes will increase our understanding of both diseases, and alert clinicians to monitor patients at high risk of disease.
Technical SummaryTwo studies will be carried out using different methodologies to address these aims. The first is a cohort study where the primary exposures are a diagnosis of COVID-19 or a positive SARS-CoV-2 test result, and the comparator is the absence of a diagnosis of COVID-19 or absence of a positive SARS-CoV-2 test result. The outcomes are new onset T1D or new onset T2D.
The study population will be all people in CPRD GOLD with >1 year data availability without diagnosis/medication of/for T1D/2 any time before index date and without previous SARS-CoV-2 infection (identified by positive PCR test). The observation period will start at 01/01/2021 and end at end of data availability. The exposure and comparator cohorts will be matched (1:1) with months as âenrolmentâ windows during 2021, without replacement.
Large scale propensity score matching methods will include age, sex, obesity, and number of healthcare visits forced into the model. The statistical analyses will encompass cohort diagnostics for the outcomes and exposure/comparator cohorts; propensity score distribution and covariate balance after matching; summary descriptive statistics for baseline characteristics for matched cohorts at index date; Cox-proportional hazard regression models for both outcomes.
The second is a Self-Controlled Case Series (SCCS) where the primary exposures are a diagnosis of COVID-19 or a positive SARS-CoV-2 test result (compared to patient time pre-COVID). The outcomes are new onset T1D or new onset T2D. The study population will be all people in CPRD GOLD with >1 year data availability and without diagnosis/medication of/for T1D/2 any time before study start (01/01/2021) and without previous SARS-CoV-2 infection before study start (01/01/2021). The statistical analyses will encompass cohort diagnostics for the outcomes and exposure/comparator cohorts; summary descriptive statistics of the study population; incidence rates and incidence rate ratios (IRR) calculated for pre-COVID and post-COVID patient time.
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Characterising baseline disease and treatment patterns in alopecia areata — Daniel Prieto...
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Characterising baseline disease and treatment patterns in alopecia areata
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-07
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Eng Hooi Tan - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Hezekiah Omulo - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
Not applicable
Description: Lay Summary
Alopecia areata (AA) is a disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body. AA can have a significant negative impact on health-related quality of life and there are limited options for effective management of AA. Until recently, there was no approved treatment. In this study, we will describe the clinical characteristics of patients newly diagnosed with alopecia areata in the years 2015-2022 and the treatments of interest among individuals after diagnosis. It is important to understand the use of existing treatment options, to provide AA patients with optimal care.
Technical SummaryAlopecia areata (AA) is a complex autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body. In this study, we will describe the baseline demographics and clinical characteristics of patients newly diagnosed with alopecia areata 2015-2022 and the treatments of interest among individuals post-diagnosis.
Study design: Cohort study
Population: Patients with AA diagnosis (index date) between 01 Jan 2015 to 31 Dec 2022 and registered for at least 2 years prior to AA diagnosis. Patients will be censored at death or end of database registration.
Variables: Demographics, clinical characteristics, comorbidities on index date, AA treatments of interest during follow-up period
Analysis:
1. To assess the created phenotypes using a comprehensive cohort characterization tool, the OHDSIâs CohortDiagnostic package
2. To describe the baseline demographic and clinical characteristics and baseline point prevalence of co-morbidities of the study cohort, we will report the number and percentage of patients with the covariates of interest.
3. To describe the occurrence and sequencing of treatment for AA post-diagnosis, we will report the number and percentage of patients initiating treatment and their lines of treatment/combination therapiesSunburst diagrams will be produced for each study cohort to visually represent the features of interest in the target cohorts. The sunburst diagram will have a maximum of 10 levels.
Each target cohort will be analysed in full and stratified by sex and age-band. Counts below minimum count of 5 will not be reported.
Hospital Episode Statistics (HES) data will be used to supplement primary care data in case there were AA diagnosis recorded in hospitals but not in primary care. HES data will also be used to characterise the number of hospitalisations in patients diagnosed with AA.
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Effect of metformin on the risk of long COVID among overweight and obese individuals: a population-based retrospective cohort study — Li Wei ...
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Effect of metformin on the risk of long COVID among overweight and obese individuals: a population-based retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-13
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Ubonphan Chaichana - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )Outcomes:
Documentation of long COVID ICD-10 code (U09.9) or long COVID symptoms (ongoing symptoms for at least 4 weeks after confirming SARS-CoV-2 infection)in patientsâ electronic health record (EHR) including fatigue, brain fog, shortness of breath, muscle aches, loss of smell, chest pain, insomnia, heart palpitation, dizziness, joint pain, pins and needles sensation, tinnitus/earaches, diarrhoea, stomach aches, cough, headache, sore throat, changes to sense of smell or taste and rashes using Read codes.
Description: Lay Summary
Many individuals who have contracted COVID-19 have reported experiencing persistent symptoms for an extended period even after recovering from the initial illness. This condition is commonly referred to as "long COVID" or "post-COVID" symptoms. Currently, there is no specific medical treatment protocol or agreed-upon definition for this condition.
Technical Summary
A recent research study has suggested that metformin, an oral medication typically used to treat diabetes, may help reduce the likelihood of developing long COVID. However, it's worth noting that this study exclusively investigated the use of metformin in individuals who are overweight or obese and between the ages of 30 to 85.
Therefore, there's a need to further investigate whether metformin's potential to lower the risk of long COVID can be observed in a broader population, specifically in individuals aged 18 and older. This proposed research aims to evaluate the impact of metformin on the risk of long COVID in overweight and obese individuals within the United Kingdom, using data collected through routine primary care health records.
By conducting this study, we seek to establish whether metformin indeed provides protection against the development of long COVID among overweight patients. Furthermore, the results of this research are expected to furnish robust evidence that can assist healthcare professionals in making informed decisions regarding the prevention and treatment of long COVID.Approximately 3.3% of UK population experienced long COVID after SARS-CoV-2 infection, and more research is needed to seek the best way of managing long COVID. Recently, the study has shown that metformin can reduce the risk of developing long COVID by 41% in overweight or obese patients. However, its real-world effectiveness remains unclear.
The studyâs aim is to investigate metforminâs impact on long COVID development in overweight and obese patients aged 18 and above using routinely collected UK primary care health data. We will conduct a cohort study using data from CPRD GOLD and Aurum linked with HES APC, HES A&E data and ONS. The study population comprises individuals meeting two criteria; aged ⥠18 years and a body mass index (BMI) ⥠25kg/m2, with a history of confirmed SARS-CoV-2 infection between February 2020 and December 2023 using Read codes. Long COVID will be compared between metformin and non-metformin users, adjusting for the covariates including patient demographics, socioeconomic status (using the patient and practice level index of Multiple Deprivation data to measure), pre-existing comorbidities, and the use of medication in the past 180 days.
The study design will follow the target trial emulation framework, creating 47 sequential trials, one for each month between February 2020 to December 2023. In each trial, eligible individuals will be assigned to a treatment group and follow up until develop long COVID, death, loss to follow up or end of follow-up, whichever occurs first. A pooled analysis of these 47 trials estimates observational equivalents of intention-to-treat and per-protocol effects. Multiple sensitivity analyses will be conducted to ensure the results' reliability. The studyâs findings can help guidelines and clinicians in determining the suitability of metformin as a long COVID-protective agent in obese patients.
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD) — Joe Maskell ...
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-28
Organisations:
Joe Maskell - Chief Investigator - Amgen Ltd
Joe Maskell - Corresponding Applicant - Amgen Ltd
Francesco Giorgianni - Collaborator - Amgen Ltd
Methodios Typou - Collaborator - Amgen Ltd
Michael Duxbury - Collaborator - Amgen LtdOutcomes:
Incidence of stroke (not including TIA) among patients with epilepsy
Description: Lay Summary
Over the last few years, organisations who make data available for public health research have been looking for ways to improve data sharing and security among users of the data. One approach that has been recommended in the UK is the use of platforms which allow access to data so analysis can be performed but limited outputs (e.g. aggregated results) can be exported. CPRD are working to establish such a platform for its users. However, it is key that the platform still enables vital health research to be performed. To help assess this, a study looking at epilepsy and stroke will be conducted.
Epilepsy is the name for a group of chronic conditions which result in repeated seizures and affects people of all ages, genders and ethnicities. Epilepsy has been linked to other conditions, including stroke. However, studies in this area have been limited and not recent.
The aims of this study are to provide more updated information on the statistics of stroke in epileptic patients while also assessing if important research can be conducted in CPRDâS secure platform. As there is a drive for more organisations to use such platforms, this research will benefit public health by ensuring such methods do not hamper research using CPRD data.
Technical SummaryThe main aim of this study is to calculate the incidence of stroke among patients with epilepsy who were prescribed anti-seizure medication. This research will benefit public health by presenting an updated picture of the disease in the UK thus highlighting areas of improvement in the management of such patients and suggesting areas for further research. Additionally, this study aims to test the use of CPRDâs secure platform to ensure it will enable data access and analysis for important health research.
This is a retrospective cohort study of epileptic patients prescribed anti-seizure medication with an incident record of stroke between 01/012010-31/12/2019 in their primary or secondary care data record.
The CPRD primary care data will be used for defining the study population. This will also be linked to the Hospital Episode Statistics Admitted Patient Care (HES APC) data (for defining the outcome of stroke), Office for National Statistics (ONS) Death Registration data (for defining the outcome of stroke and the date of death), and patient-level Index of Multiple Deprivation (IMD) data (as a covariate).
Descriptive results will be presented for patient demographics and incidence rates will also be calculated as the number of newly diagnosed stroke events in patients with epilepsy (numerator) divided by the sum of the person years of follow-up of epileptic patients during each calendar year of interest. The rates will be stratified by age group, gender, and year of stroke diagnosis.
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD) — Susan Jick ...
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-28
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Daniel Huff - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Incidence of stroke among patients with epilepsy
Description: Lay Summary
Over the last few years, organisations who make data available for public health research have been looking for ways to improve data sharing and security among users of the data. One approach that has been recommended in the UK is the use of platforms which allow access to data so analysis can be performed but limited outputs (e.g. aggregated results) can be exported. CPRD are working to establish such a platform for its users. However, it is key that the platform still enables vital health research to be performed. To help assess this, a study looking at epilepsy and stroke will be conducted.
Epilepsy is the name for a group of chronic conditions which result in repeated seizures and affects people of all ages, genders and ethnicities. Epilepsy has been linked to other conditions, including stroke. However, studies in this area have been limited and not recent.
The aims of this study are to provide more updated information on the statistics of stroke in epileptic patients while also assessing if important research can be conducted in CPRDâS secure platform. As there is a drive for more organisations to use such platforms, this research will benefit public health by ensuring such methods do not hamper research using CPRD data.
Technical SummaryThe main aim of this study is to calculate the incidence of stroke among patients with epilepsy who were prescribed anti-seizure medication. This research will benefit public health by presenting an updated picture of the disease in the UK thus highlighting areas of improvement in the management of such patients and suggesting areas for further research. Additionally, this study aims to test the use of CPRDâs secure platform to ensure it will enable data access and analysis for important health research.
This is a retrospective cohort study of epileptic patients prescribed anti-seizure medication with an incident record of stroke between 01/012010-31/12/2019 in their primary or secondary care data record.
The CPRD primary care data will be used for defining the study population. This will also be linked to the Hospital Episode Statistics Admitted Patient Care (HES APC) data (for defining the outcome of stroke), Office for National Statistics (ONS) Death Registration data (for defining the outcome of stroke and the date of death), and patient-level Index of Multiple Deprivation (IMD) data (as a covariate).
Descriptive results will be presented for patient demographics and incidence rates will also be calculated as the number of newly diagnosed stroke events in patients with epilepsy (numerator) divided by the sum of the person years of follow-up of epileptic patients during each calendar year of interest. The rates will be stratified by age group, gender, and year of stroke diagnosis.
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Investigating prescription cascades and adverse drug reactions of dementia drug treatments — Danielle Newby ...
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Investigating prescription cascades and adverse drug reactions of dementia drug treatments
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-03
Organisations:
Danielle Newby - Chief Investigator - University of Oxford
Danielle Newby - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of OxfordOutcomes:
The outcomes to be measured for this study are:â¯
Prescription/use of dementia medications: Acetylcholinesterase inhibitors: Donepezil, rivastigmine, and galantamine, or memantine. Prescription patterns of medications in potential prescription cascades before and after starting dementia medications.
Description: Lay Summary
Dementia is an umbrella term used to describe a group of symptoms that affect a person's cognitive abilities, such as their memory, thinking, and reasoning skills. Dementia can be caused by various diseases, with Alzheimer's disease being the most common cause. There are currently only four drug treatments on the market that are recommended to manage symptoms of mild to severe dementia, specifically Alzheimer's disease. Clinical trials have shown mixed results about how good these drugs are, and they have lots of side effects. Unfortunately, sometimes, doctors treat these side effects as new symptoms/diseases rather than side effects of dementia drugs. This is called a âprescription cascadeâ. It is important to characterise what dementia treatments and other drugs are given as it will help patients, health care providers, and regulatory authorities help manage the disease to enhance patient benefit and reduce mortality. Real-world data such as medical records can help give us further insight into what dementia treatments are initially given as well as other drugs that are given before and after. This study will describe what new drugs are given after dementia treatment starts and will describe the characteristics of these different groups of patients.
Technical SummaryBACKGROUND
There is no cure for dementia and approved drugs have shown inconclusive effectiveness and numerous side effects. The side effects of dementia drug treatments can sometimes be misinterpreted as new medical conditions and additional drugs are prescribed which leads to unnecessary drug therapy leading to a prescription cascade. Persons living with dementia are more vulnerable to prescribing cascades due to increased multimorbidity. In-depth characterization of those on dementia drugs will give crucial insights into the management of disease to healthcare providers, regulatory authorities and patients.
The aim of this project is to characterize the treatments of patients taking dementia drugs and determine potential prescription cascades.
OBJECTIVES:
1) To characterise demographics, comorbidities and medications prescribed to patients before and after a prescription of dementia medication.â¯
2) To determine potential prescription cascades using Prescription Sequence Symmetry Analysis (PSSA).â¯METHODS:
Data: CPRD GOLD
Participants: All adults registered in CPRD GOLD for at least 1 year and older than 18 with a prescription for dementia drug (Donepezil, rivastigmine, galantamine, memantine).
Descriptive analysis will be used to describe the demographics and clinical characteristics of patients taking dementia treatments and other drug treatments. Prescription sequence symmetry analysis will be used to determine potential prescription cascades.
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Advantages and Disadvantages using Different Marginal Structural Models Interval Durations in Pharmacoepidemiology — Samy Suissa ...
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Advantages and Disadvantages using Different Marginal Structural Models Interval Durations in Pharmacoepidemiology
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-15
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
In-Sun Oh - Collaborator - McGill University
Michael Webster-Clark - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
⢠Major adverse cardiovascular events (MACE; composite endpoint of myocardial infarction, ischemic stroke, and cardiovascular death)
⢠Individual components of MACE
⢠All-cause mortality
⢠Methodological outcomes (relative bias, mean square error of the estimates of interest, range of extreme weight, proportion of extreme weight, and rate of censored subjects)Description: Lay Summary
Marginal structural models (MSMs) are statistical methods used to examine how treatments change over time. To ensure accurate results, it is important to choose appropriate time intervals when applying these statistical models. However, the impact of selecting different time interval durations for MSMs is not well understood. Different time intervals and approaches can influence the accuracy of results. In this methodological study, we aim to investigate how diffferent time interval approaches affect MSMs by examining this issue in a specific clinical example: comparing sulfonylurea versus metformin as first line therapies and the risk of major adverse cardiovascular events (an outcome characterized by blocked arteries that includes heart attacks, strokes, and dying of heart-related causes) among patients with type 2 diabetes (a condition characterized by elevated blood sugar levels). To achieve this aim, we will use a simulated cohort that we will create using a statistical approach called a plasmode framework. The plasmode simulation framework allows to modify data while preserving the underlying relationships observed in the real data. We will create 9 simulation scenarios with different methodological aspects. We will conduct a real-world case study comparing sulfonylurea versus metformin and their associated risk of major adverse cardiovascular events between September 1st 2002 and March 31st 2022 to illustrate how results are affected by different time intervals in MSMs.
Technical SummaryMarginal Structural Models (MSMs) are statistical models used to examine the effects of time-varying treatments or exposures in longitudinal studies. They are often used in studies that involve time-to-event data and are estimated using the inverse-probability-of-treatment weighting (IPTW) estimator. However, the choice of time intervals for MSMs can have an important impact on data granularity, computational burden, and the risk of extreme weights, which may lead to biased estimates. To better understand the impact of different time interval durations on MSMs, this study will compare the use of different time intervals and approaches in a case study comparing sulfonylurea versus metformin as first line therapy and the risk of major adverse cardiovascular events (MACE) among patients with type 2 diabetes. The study will use a plasmode simulation framework to generate data and establish 9 simulation scenarios with varying prevalence of outcome and censoring to compare the occurrence of extreme weight with different time intervals using MSMs. We will also examine other concerns: the first one is to explore how the impact of different lengths of patient's follow-up, resulting in varying numbers of time intervals, may lead to fragility with extreme weight. We will also explore potential problems that can arise from fitting pooled prediction models. Finally, we will conduct a real-world case example that evaluates the cumulative effect of sulfonylurea compared with metformin on MACE in patients with type 2 diabetes between September 1st 2002 and March 31st 2022 will be conducted to illustrate the effect of different time intervals on estimates and weights using MSMs.
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Identification of vascular patients at high bleeding risk: validation of the European Socitiety of Cardiology's high bleeding risk criteria — Kausik Ray ...
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Identification of vascular patients at high bleeding risk: validation of the European Socitiety of Cardiology's high bleeding risk criteria
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-06
Organisations:
Kausik Ray - Chief Investigator - Imperial College London
Maria Castelijns - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Frank Visseren - Collaborator - Utrecht University
Laura Gunn - Collaborator - Imperial College London
Steven Hageman - Collaborator - Imperial College LondonOutcomes:
Clinically relevant bleeding classified as Bleeding Academic Research Consortium bleeding types 2-5; major bleeding events requiring hospital admission or resulting in death; non-bleeding death.
Description: Lay Summary
This research focuses on patients with heart-related diseases who are often prescribed blood-thinning drugs to help prevent future heart problems. Even with the best care and treatment, some people remain at high risk for more heart problems. In these cases, additional blood-thinning drugs may help reduce this risk. However, these drugs come with a catch: they can increase the chance of bleeding. Therefore, physicians are advised that blood thinnersshould only be used for patients who are not at a high risk of bleeding. To check this, there are certain criteria in prevention guidelines, such as old age, previous bleedings or problems with the liver or kidneys. But it's not clear how likely these patients are to experience bleeding.
This study aims to find out how many patients with heart disease meet the criteria for high bleeding risk and to assess their actual chances of bleeding.
Technical SummaryAntithrombotic therapy is one of the secondary prevention pillars in patients with established cardiovascular disease. Intensification of antithrombotic treatment can be considered in patients with a high residual cardiovascular event risk, as is stated in the 2021 ESC guideline on CVD prevention. Given the possible harm of bleeding complications inflicted by antithrombotics, ESC guidelines on chronic coronary syndromes (2019) and peripheral artery disease (2017) advise that this intensified treatment should only be considered in patients without a high risk of bleeding. HBR criteria are listed in these documents to identify patients at high bleeding risk: history of intracerebral haemorrhage or ischemic stroke, history of other intracranial pathology, recent gastrointestinal bleeding or anaemia due to possible gastrointestinal blood loss, other gastrointestinal pathology associated with increased bleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age or frailty or renal failure requiring dialysis or with estimated glomerular filtration rate (eGFR) <15 mL/min. These criteria correspond to exclusion criteria of trials on intensification of antithrombotic therapy, but the actual bleeding risk of patients meeting these criteria is unknown. This is of importance for shared decision making, since an increase in bleeding risk may be acceptable where there is very high residual risk of an ischemic cardiovascular event. The goal of this study is to describe the prevalence of the HBR criteria and the actual major bleeding risk among individuals meeting these criteria. Prevalence of HBR criteria will be described for a cohort of patients with established CVD, and Hospital Episode Statistics (HES) admission and Office for National Statistics (ONS) mortality data will be used to assess and compare incidence rates of bleeding events adjusted for non-bleeding deaths, for patients meeting and not meeting any HBR criterion and individual HBR criteria.
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Evaluating connective tissue diseases and vasculitis services in England using patient outcomes: a model for national audit — James Galloway ...
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Evaluating connective tissue diseases and vasculitis services in England using patient outcomes: a model for national audit
Datasets:GP data, HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-02
Organisations:
James Galloway - Chief Investigator - King's College London (KCL)
Samir Patel - Corresponding Applicant - King's College London (KCL)
Edward Alveyn - Collaborator - King's College London (KCL)
Kate Bramham - Collaborator - King's College London (KCL)
Mark Russell - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Maryam Adas - Collaborator - King's College London (KCL)
Patrick Gordon - Collaborator - King's College London (KCL)
Zijing Yang - Collaborator - King's College London (KCL)Outcomes:
Primary outcome: Delay in diagnosis of CTD or vasculitis
Key secondary outcomes: 1) diagnostic incidence; 2) time to prescription of disease-modifying medications; 3) incidence of disease-specific organ damage and 4) all-cause 1-year mortality.
Description: Lay Summary
Autoimmune conditions are rare diseases where the body attacks its own tissues and can lead to disability, long-term complications and death. Early diagnosis and treatment are essential to improving outcomes from these conditions. Over the last 20-years there have been significant advances in investigations and management of these conditions. However, access to hospital services, diagnostics and medications vary across the country and within the NHS. This study will describe trends in the outcomes of patients with specific autoimmune conditions and examine the effectiveness of services against guideline-driven parameters in England. As certain diseases are more common and occasionally thought to be more severe in particular ethnicities (e.g. lupus and Black ethnicity), we will also investigate whether a patientâs ethnicity or social background affects their disease outcomes.
We will be evaluating services from January 2015 to December 2022 by examining GP records via CPRD. We will describe the trends of key patient-related outcomes, including time to first hospital appointment and treatment; rates of disease-related complications (such as kidney failure) and death.
This project will provide doctors and patients with an evidence base for clinical pathways to manage specific autoimmune conditions which affect organ tissues and blood vessels (connective tissue diseases and vasculitis). We will also search for and investigate any health inequalities with a view to reducing differences and improving long-term outcomes for all patients.
Technical SummaryConnective tissue diseases (CTD) and vasculitis are multi-system disorders associated with high morbidity and mortality. Timely diagnosis and management are vital for optimising outcomes in patients who often present with indolent initial symptoms. CTD and vasculitis survival rates have generally improved over time; however, they remain higher than the general population. Survival trends in the UK have not been explored since the regular use of biologic therapies for CTD or vasculitis. Furthermore, general trends in survival often underestimate potentially significant variation and inequities within patient groups and regions. Poor outcomes are often linked to ethnicity and age in patients with systemic lupus erythematosus (SLE), particularly Black ethnicities and younger age. Our goal is to use routinely collected health data to describe service delivery and health outcomes for people with CTD or vasculitis over a defined period, highlighting any health disparities within this vulnerable population.
Our study population will be individuals aged 18-104 years with incident diagnostic SNOMED codes for CTD or vasculitis who are registered with a primary care practice contributing to CPRD Aurum from January 2012 to December 2022.
We will describe attainable metrics regarding diagnostic incidence, medication initiation, disease-specific complications and all-cause mortality for CTD or vasculitis. We will search for the first appearance of relevant SNOMED codes, medication or complications using primary care records. A control group will be utilised to determine age, gender and ethnicity-adjusted mortality rate ratios. We will use interrupted time-series analyses and Poisson regression models to describe the incidence of disease-specific outcomes and mortality. Our over-arching goal will be to describe any variation in care across the country and to investigate its explanatory factors (e.g. deprivation, ethnicity). Output from this study will be submitted to a peer-reviewed journal and will help steer future UK CTD and vasculitis guidelines.
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Temporal validation of prognostic models for chronic obstructive pulmonary disease (COPD) and evaluation of methods to correct for calibration drift. — Sarah Booth ...
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Temporal validation of prognostic models for chronic obstructive pulmonary disease (COPD) and evaluation of methods to correct for calibration drift.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-01
Organisations:
Sarah Booth - Chief Investigator - University of Leicester
Jonathan Broomfield - Corresponding Applicant - University of Leicester
David Jenkins - Collaborator - University of Manchester
Haya Elayan - Collaborator - University of Manchester
Mark Rutherford - Collaborator - University of LeicesterOutcomes:
Mortality (at 1, 5 and 10 years of follow-up following COPD diagnosis)
Description: Lay Summary
Prognostic models estimate future outcomes or risks associated with a particular disease for an individual patient. These models use various patient characteristics (like age and smoking status) and clinical data (like blood pressure) to generate predictions about a patient's prognosis. These predictions are used by healthcare professionals in treatment planning, particularly for chronic diseases where predicting the course of the illness can help guide interventions and improve patient outcomes.
One such chronic disease for which many prognostic models have been developed is chronic obstructive pulmonary disease (COPD), a progressive lung disease affecting the ability to breathe. Provided a diagnosis is made early, patients can live for 10 to 20 years. Models have been developed to predict the risk of death up to 10 years after diagnosis, meaning that patients from 10 to 20 years ago are included in the model. However, survival both in the disease area and in the general population may have improved since then. This means that by the time the model is published it may already be, or soon become, out of date.
We will evaluate three existing COPD prognostic models and assess how accurate their predictions are in the current UK population. If the predictions are out of date we will evaluate methods that can be used to update these models to provide more accurate predictions for new patients.
Technical SummaryPrognostic models are statistical algorithms that predict the risk of a future event occurring in a particular disease or health condition. They contain multiple predictors such as patient characteristics and clinical data, and are usually developed using logistic or survival regression. The predictions are used by healthcare professionals in treatment prescriptions and disease management, particularly for chronic diseases like cancer and diabetes where predicting the course of the illness can guide interventions and improve patient outcomes.
One such chronic disease for which many prognostic models have been developed is chronic obstructive pulmonary disease (COPD), a progressive lung disease that is particularly prevalent in smokers. The focus of many of these models is mortality at different time points after diagnosis. Models producing longer-term predictions require longer follow-up to estimate the risk of the outcome, meaning that patients diagnosed many years ago have to be included. However, if survival outcomes have improved, the risk for these patients may be different to more recently diagnosed patients, which leads to model miscalibration.
Using recent data we will temporally validate three prognostic models for COPD mortality to evaluate the drift of these models over time, assess the need for recalibration, and if required, recalibrate them for the current UK population.
Period analysis can be used for time-to-event prognostic modelling by using more recent cohorts, but this decreases the sample size which can lead to overfitting. Instead, we will evaluate newly developed methods including temporal recalibration and weighted regression. In temporal recalibration, the predictor effects from the full cohort are preserved while baseline mortality is updated based on a period analysis, giving up-to-date recalibrated predictions that utilise the power of the full sample size. A weighted regression approach accounts for the case-mix to investigate model recalibration by re-weighting the data according to the observed distribution shift.
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Healthcare inequalities in neurodevelopmental conditions: trends in co-occurring conditions, prescriptions, and outcomes. — Paul Madley...
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Healthcare inequalities in neurodevelopmental conditions: trends in co-occurring conditions, prescriptions, and outcomes.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-02
Organisations:
Paul Madley-Dowd - Chief Investigator - University of Bristol
Aws Sadik - Corresponding Applicant - University of Bristol
Antonio Fernández Pardiñas - Collaborator - Cardiff University
Dheeraj Rai - Collaborator - University of Bristol
Golam Khandaker - Collaborator - University of BristolOutcomes:
1) Commonly co-occurring mental and physical health diagnoses
2) Prescriptions of commonly prescribed medications, including antidepressants, antipsychotics and lipid lowering medications
3) Subsequent adverse health outcomes, including medication effects, for example in the case of antipsychotics these would include dyslipidaemia, obesity, hypertension and diabetes.
4) All-cause mortality; cause-specific mortalityDescription: Lay Summary
People with neurodevelopmental conditions such as autism, intellectual disabilities (ID) and attention deficit hyperactivity disorder (ADHD) tend to have more health problems and a shorter life expectancy than people without a neurodevelopmental condition. Receiving too many or too few medications may contribute to this. For example, high cholesterol can increase the chance of heart attacks and strokes. Some mental health medications can increase cholesterol levels. On the other hand, statins help reduce cholesterol but it is possible that they are not offered to people with neurodevelopmental conditions when they should be .
We will use UK healthcare records to understand changes in prescriptions of commonly prescribed medications, and the conditions they are prescribed for, over time for people with neurodevelopmental conditions.
By comparing diagnoses, prescriptions, and later records of side effects and health outcomes, we will try to determine whether there seems to be over or under prescription of certain medications for people with neurodevelopmental conditions.
As each single method of studying this question is imperfect, we will compare the results from a range of approaches and see if they give consistent answers.
We hope this work will help in understanding the inequalities in health outcomes for people with neurodevelopmental conditions, to provide better healthcare and reduce side effects from medications.
Technical SummaryObjective & Rationale:
To understand whether there are inequalities in healthcare, prescribing, and associated outcomes for those a neurodevelopmental condition compared to those without. This should help to empower patients and professionals to make informed medication and service design decisions.Aims:
i) Describe time trends in commonly co-occurring conditions and associated prescriptions for people with neurodevelopmental conditions;
ii) Assess whether adverse health outcomes, including medication effects, are more likely to be recorded for people with neurodevelopmental conditions;
iii) Triangulate evidence from multiple methods to strengthen causal inferenceStudy design: Descriptive and comparative cohort study
Setting: UK CPRD primary care records linked to Hospital Episodes Statistics (HES) for diagnoses and hospitalisation data, Office of National Statistics (ONS) death records, and sociodemographic data.
Primary exposures:
(i) Lifetime diagnosis of a neurodevelopmental condition, including autism, intellectual disability and attention deficit hyperactivity disorderPrimary outcomes:
(i) Commonly co-occurring mental and physical health conditi ons (e.g. depression, high cholesterol)
(ii) Prescriptions for common psychotropic (e.g. antidepressants, antipsychotics) and physical health medications (e.g. lipid lowering agents).
(iii) Potential adverse medication effects (e.g. obesity with antipsychotic use).
(iv) All-cause and cause-specific mortality.Methods including main statistical tests:
1) Descriptive statistics for each medication group, including prevalence and incidence of prescriptions and their indications, by age group, calendar year, and diagnostic status. Also patterns of prescription such as time to discontinuation assessed using confounder adjusted cumulative incidence.
2) Calculation of the risk of adverse health outcomes, including medication effects , at multiple lengths of follow up, in addition to the cumulative incidence, for the groups defined by the combination of medication prescription and neurodevelopmental diagnosis. We will calculate the risk differences and relative risk using confounder adjusted regression models.
3) Triangulating results from multiple methods within the cohort, such as target trial emulation, propensity score matching, negative controls.
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Prescribing of domperidone among postpartum women: feasibility for a study on off-label prescribing. — Katherine Donegan ...
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Prescribing of domperidone among postpartum women: feasibility for a study on off-label prescribing.
Datasets:GP data, CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-02
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Svetlana Buzdugan - Corresponding Applicant - MHRAOutcomes:
The following outcome measures would be calculated from the Pregnancy Register data linked to CPRD Aurum data:
⢠The number (proportion) of women who received at least one prescription for domperidone during pregnancy or postpartum;
⢠The number of prescriptions per woman, start and duration of treatment.
⢠The list of indications of domperidone prescriptions will be described and their frequencies presented.
⢠Descriptive statistics will be conducted to quantify the number of prescriptions in different strata of the study population (e.g., during pregnancy and after delivery, by gestational age, postpartum period, and maternal age).
⢠Multiple pregnancies and prescriptions will be allowed per woman.If the stratified analysis will result in small cell counts (<5 events per patient), for instance when the distribution of prescriptions is produced according to maternal age, the grouped age categories of maternal age will be produced to include a summary of cells with low counts. This will minimise the risk of inadvertently identifying patients or practices during the conduct or publication of the study.
Based on the outcome measures listed above, the feasibility of a retrospective cohort study will be concluded where comorbidity profile and concomitant therapy will be used to work out the indications for the use of domperidone.Description: Lay Summary
Domperidone is a medication which is licenced for nausea and vomiting. In addition to the licenced indications, domperidone is also can be given to start or increase breast milk production following childbirth. However, this unlicenced indication of domperidone for breast milk production can be associated with side effects of depression, anxiety and insomnia. Currently, it is not known how much unlicenced use of domperidone there is in the UK. Therefore, the size of the population at risk of adverse reactions associated with the use of domperidone such as depression, anxiety and insomnia needs to be estimated.
Technical Summary
The current study aims to quantify the use of domperidone in postpartum women, so the feasibility of a retrospective cohort study to describe the prescribing of domperidone to women postpartum can be concluded. The results of the cohort study will help us to identify the recording of prescriptions of unlicenced use of domperidone for starting or increasing breast milk production which will aid in our assessment of risks of adverse reactions. This will enable us to direct advice on the use of domperidone to those populations.Domperidone is a dopamine receptor antagonist which stimulates peristalsis and is licenced for the treatment of nausea, vomiting and gastric pain. Domperidone also increases prolactin levels and therefore, in addition to licenced indications, is given off-label as a galactagogue. The off-label use of domperidone as a lactation stimulant is associated with an increased risk of depression, anxiety and insomnia. The extent of off-label use of domperidone is unknown but could be widespread. However, the identification of off-label use is challenging as it is not known what codes are used by GPs to record this usage. Therefore we aim to estimate the size of the population at risk of adverse reactions associated with the use of domperidone.
The feasibility study will quantify domperidone prescriptions in pregnant and postpartum women who are likely to be given the domperidone off-label. This study will use CPRD Aurum data to identify prescriptions of domperidone, and the Pregnancy Register data set will provide a study population. The null hypothesis is that the proportion of prescriptions before and after the delivery of a baby is the same. Any discrepancies in counts will be noted and the assumption that the prescription of domperidone after live birth until a baby is six months old is given off-label for lactation stimulation will be explored.
The analysis will quantify the number of domperidone prescriptions given between 2000 and 2023 to women who had a live birth, thus quantifying the prescribing of domperidone in a population of pregnant and postpartum women and comparing indications. The study findings will support the development of a list of codes to identify the off-label use of domperidone in a subsequent retrospective cohort study. The findings will aid in the planning of safety monitoring activities, including epidemiological studies to explore complications associated with off-label prescribing of domperidone.
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Early identification of the association between rofecoxib and cardiovascular adverse events using real-world data from the UK: a case-control and case-crossover design — Shahab Abtahi ...
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Early identification of the association between rofecoxib and cardiovascular adverse events using real-world data from the UK: a case-control and case-crossover design
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-15
Organisations:
Shahab Abtahi - Chief Investigator - Utrecht University
Shahab Abtahi - Corresponding Applicant - Utrecht University
Donya Moslemzadeh - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht UniversityOutcomes:
Occurrence of first-ever major adverse cardiovascular event (MACE), defined as myocardial infarction (MI), stroke, and heart failure (HF). The outcome of interest will be assessed both as the composite outcome (i.e., MACE), and as the individual components (i.e., MI, stroke, HF) separately.
Description: Lay Summary
Non-steroidal anti-inflammatory drugs (NSAIDs) are common painkillers that are used to reduce pain, inflammation, and fever. Old-generation NSAIDs can cause discomfort, ulcer, and bleeding in the stomach. To overcome this, a newer class of painkillers, called COX-2 inhibitors were developed with fewer stomach side effects. However, rofecoxib, as a COX-2 inhibitor, was found in a clinical trial to increase the risk of heart attack compared to naproxen (an older NSAID). It took the manufacturer five years to withdraw rofecoxib from the market due to higher risks of heart attacks and strokes.
Technical Summary
Historically, detecting adverse drug reactions (ADRs) of a new medication relies on spontaneous reporting systems (SRSs), where patients or doctors report suspected adverse events. However, this has limitations such as difficulty in detecting some common events. In case of rofecoxib, SRS could not detect cardiovascular events earlier. Nowadays, with increasing access to real-world data (RWD), various studies can be conducted to investigate the safety profile of medications.
This study aims to use RWD from the UK's CPRD to assess if the cardiovascular risks of rofecoxib (heart attack, stroke and heart failure) could have been detected earlier. We will compare results from two study designs and proposed methodologies to improve signal detection methods, by using the case study of rofecoxib and cardiovascular risks.
By answering our research question, we aim to develop methods for detecting ADRs using RWD earlier than conventional SRSs. This will benefit patient care and policy making for swifter detection of ADRs in real patient groups.Objectives: To study whether the cardiovascular adverse effects of rofecoxib could have been detected earlier if real-world data (RWD) had been utilised with any of case-control or case-crossover designs and proposed methodologies. Furthermore, we will compare the produced risk estimates from the two mentioned designs in order to understand the accuracy, validity, and robustness of findings from each design. Our aim is to use the rofecoxib example as a proof-of-concept study to develop methods for detecting ADRs using RWD earlier than the conventional pharmacovigilance methods.
Design: Nested case-control and case-crossover designs using a linkage of Clinical Practice Research Datalink (CPRD) GOLD and Hospital Episode Statistics Admitted Patient Care (HES APC).
Participants: All adult patients (â¥18 years of age) in CPRD between 20 May 1999 and 30 September 2004 with a diagnosis of rheumatoid arthritis, osteoarthritis and low-back pain, to choose the cases and controls from.
Exposure: Rofecoxib use.
Outcome: First ever major adverse cardiovascular event (MACE) defined as myocardial infarction (MI), stroke, and heart failure (HF).
Statistical analyses: Conditional logistic regression will be used in both study designs to identify the association between rofecoxib and MACE. In the case-control study, a cumulative uptake time analysis will be done to identify the shortest time necessary to identify a MACE outcome among rofecoxib users. The secondary analyses will focus on potential dose-response and duration-response effects among the current users of rofecoxib. The analyses will be stratified by effect modifiers (i.e., age, sex and indications of rofecoxib use). In the case-crossover study, we will adjust for time trends of the exposure and we will do sensitivity analyses with risk windows defined as 6 months and 12 months, instead of 3 months in the main analysis. In both designs, separate analyses will be conducted for each individual outcome measure.
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Characterising the clinical features and healthcare resource use associated with thalassaemia in England: a retrospective cohort study — Jennifer Davidson ...
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Characterising the clinical features and healthcare resource use associated with thalassaemia in England: a retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-01
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
James Baird - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Rebeka McClintock - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
Key symptoms of thalassaemia (defined as fatigue, dyspnoea, syncope, and jaundice); Comorbidities and complications of thalassaemia; Mortality; Progression from non-transfusion-dependent thalassaemia to transfusion-dependent thalassaemia; Number of all-cause inpatient admissions; Costs of all-cause inpatient admissions; Length of all-cause inpatient stay in those with at least one inpatient admission; Number of all-cause outpatient visits; Costs of all-cause outpatient visits; Number of all-cause emergency care attendance; Costs of all-cause emergency care attendances; Number of transfusions; Costs of transfusion visits; Days between transfusions; Number of all-cause primary care consultations; Costs of all-cause primary care consultations; Number of primary care prescriptions (any); Number of iron chelation therapy prescriptions (desferrioxamine mesylate, deferiprone, deferasirox, dexrazoxane); Duration of iron chelators prescriptions; Number of MRI scans; Costs of MRI visits; Number of bone mineral density scans; Costs of bone mineral density scan visits; Cost of lost productivity; Lost future income
Description: Lay Summary
Thalassaemia is a blood disorder passed from parents to children. People with thalassaemia produce either no or too little of a substance called haemoglobin, which carries oxygen around the body. Some people will have noticeable symptoms within months of their birth and others not until later in life. As a result of their lack of haemoglobin, people with thalassaemia may experience tiredness, weakness, and an irregular heartbeat. Often, they will require regular blood transfusions, and as a result of the transfusions people with thalassaemia may have other health problems including problems with their heart or liver. Due to the necessary treatment, symptoms of thalassaemia, and possible resulting health problems, people with thalassaemia need to attend healthcare often.
The level of haemoglobin and time at which the previously mentioned health problems develop are not well understood. We will use anonymous data from GP and hospital records from England to describe the occurrence of these health problems as well as death, the level of haemoglobin at which individuals with thalassaemia have problems, the burden a change in haemoglobin level has on the amount of healthcare attendance people with thalassaemia have, and the current treatment patterns for thalassaemia.
The results will increase understanding of how treatments that increase haemoglobin levels can be used to lower the occurrence of health problems and the burden on the healthcare system for people with thalassaemia, to guide possible improvements and standardisation of patient care and treatment to improve the well-being of people with the condition.
Technical SummaryThalassaemia syndromes are inherited blood disorders characterized by dysregulation of haemoglobin, resulting in ineffective red blood cell (RBC) production, reduced functional haemoglobin in RBCs, and anaemia. Individuals with thalassaemia can have transfusion-dependent thalassaemia (TDT) or non-transfusion-dependent thalassaemia (NTDT), depending on presentation and the need for regular transfusions. Complications can develop due to symptoms or treatment, leading to multisystemic manifestations of the disease.
In this retrospective cohort study, we will use linked data from Clinical Practice Research Datalink (CPRD) Aurum, Hospital Episode Statistics, Diagnostic Imaging Dataset, Office for National Statistics death registrations, and Index of Multiple Deprivation, to assess the association between a 1 gram per decilitre (g/dL) decrease in haemoglobin among patients with TDT and NTDT (separately) and percentage increase in symptoms, complications, comorbidities and mortality, along with healthcare resource use (HCRU) and cost in adults with NTDT and TDT using appropriate regression methodologies. We will compare incidence of symptoms, complications, comorbidities and mortality, along with HCRU and costs between adults with TDT or NTDT and without thalassaemia (matched on age, sex, ethnicity, CPRD practice, follow-up time). Poisson regression will be used to model occurrence of symptoms, complications, comorbidities, Cox proportional hazards regression will be used for the outcome of death, generalised linear models (GLM) with negative binomial distribution for HCRU events and GLM with gamma family for healthcare cost. We will explore treatment patterns for adults with thalassaemia, progression from NTDT to TDT and its effect on complications and mortality, indirect productivity loss due to sickness or engaging with healthcare services, and loss of future income due to long-term unemployment, medical retirement, or death.
The results will increase understanding of how treatments that increase haemoglobin affect risk of complications, mortality and healthcare burden for people with thalassaemia in England, to guide improvements and standardisation of patient care and treatment.
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Understanding the hip and knee osteoarthritis-arthroplasty pathway and improving Day Case Arthroplasty patient selection — Omar Musbahi ...
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Understanding the hip and knee osteoarthritis-arthroplasty pathway and improving Day Case Arthroplasty patient selection
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-30
Organisations:
Omar Musbahi - Chief Investigator - Imperial College London
Omar Musbahi - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College LondonOutcomes:
1. Length of Stay.
2. Community and Hospital Burden Outcome measures(ED attendance; Outpatient follow up visits; reoperation; GP visits pre and post operatively).
3. Post-Operative Complications (Mortality; Reoperation/Revision surgery; Major cardiac event; cerebrovascular attack; Venous Thromboembolic event).Description: Lay Summary
Covid has created a significant impact on the lives of patients with joint and muscular disease. There
are a significant number of patients who have not presented to General Practice or
hospital services and who are likely to present in the next few years. These "Hidden"
patients are expected to cause a huge burden on health services.
To plan safe and efficient surgery we require a better understanding of the patients
undergoing surgery. There is a need to understand the group of patients that can safely be
operated on and sent home the same day (âday casesâ). Furthermore, more than 10%
of all surgery patients will have some sort of complication after an operation.
Some surgeons feel that patients are discharged too early, and some are discharged too late. There is a need
to determine the patient characteristics that would benefit from day case surgery.
This research aims to use available national data to help streamline patientâs experiences and improve understanding of patients undergoing surgery for muscular and joint diseases.Aims and Objectives:
1. To find out more about UK patients with joint and muscular diseases and those undergoing routine elective procedures and the number of GP visits and hospital visits they have.2. To understand the pre-operative and post-operative patient features undergoing elective surgery.
3. To understand the complications after daycase and non-daycase elective surgery with emphasis on A&E attendance, readmission and clinic visits.
4. To address the short-term and long-term complications of routine muscular and joint replacement procedures.
Technical SummaryCovid has created a significant impact on the lives of musculoskeletal patients. A number of
patients have not presented to General Practice or hospital services and are likely to present in the future. There is a need to determine the participant characteristics that can safely be operated on and sent home the same day (âday casesâ).Study Design: Descriptive, Hypothesis Testing
Population of interest: Patients with any hip and knee symptom presenting to primary care or who have a diagnosis of Hip and Knee Osteoarthritis in primary and secondary care from April 2004- December 2023.
Objectives:
1. To describe the presentation history and progression of osteoarthritis and elective hip and knee replacement surgery patients in the UK.
2. To explore the post-operative complications and healthcare service burden after hip and knee replacement surgery using data from both primary and secondary care.
3. To determine those who are appropriate candidates for day-case hip and knee replacement surgery.Primary Outcomes: Patient Outcomes (surgery, complications, mortality, reoperation) and Hospital and Community service Burden (e.g. attendance, waiting times, service use).
Methodology:
Using descriptive statistics, we will use linked CPRD data to describe the current musculoskeletal cohort that present to primary care with common knee and hip symptoms and are then referred to hospital. We will describe the time from the initial symptom presentation in primary care to post operative course history. Using a combination of propensity score matching and time-to-event analysis (Cox Proportional Hazards Model), we will determine the short-term and long-term outcomes of patients who have undergone Hip Replacement (compared with Hip Resurfacing) and Total Knee Replacement (compared with Unicompartmental Knee Replacement).Intended Benefits:
This will provide NHS, surgeons, and policy planners with information on where to focus funding and provide policy to improve this to assess how to reduce waiting list times.
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The association between timing within the school year and clinical presentations for depression, anxiety, and self-harm — Gemma Lewis ...
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The association between timing within the school year and clinical presentations for depression, anxiety, and self-harm
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-06
Organisations:
Gemma Lewis - Chief Investigator - University College London ( UCL )
Marie Mueller - Corresponding Applicant - University College London ( UCL )
Joseph Hayes - Collaborator - University College London ( UCL )
Neil Davies - Collaborator - University College London ( UCL )Outcomes:
Primary outcomes
- CPRD diagnoses and symptoms of depression and anxiety (focus on GAD)
- CPRD prescriptions for depression and anxiety (focus on SSRIs)
- HES admissions for self-harmSecondary outcomes
- CPRD diagnoses of ADHD
- CPRD prescriptions for ADHD (focus on methylphenidates)Negative control outcomes
- Physical health outcomes not associated with academic pressure (e.g., appendectomy)Description: Lay Summary
Adolescence is an important period for the development of mental health problems, with around 50% of all diagnosed mental disorders worldwide starting before the age of 18 years. Moreover, rates of depression, anxiety, and self-harm are rising in the UK and globally. Nonetheless, we have a limited understanding of what causes mental health problems. Finding modifiable risk factors is important to prevent the development of these mental health problems.
A potential factor that may play a role in adolescent mental health is academic pressure, and there are widespread concerns about the potential negative impact of academic pressure on adolescent mental health. However, the association has rarely been investigated.
In our study, which is part of a larger project, we will investigate the association between academic pressure and adolescent mental health, using electronic health record data. We will study how timing in the school year is associated with adolescent primary care and hospital visits for depression, anxiety, and self-harm. Based on conversations with students and teachers, we would expect clinical presentations to be highest around the time of exams and, especially, national âhigh-stakesâ exam times (i.e., May and June). This is because testing and national exam times are periods when adolescents tend to experience higher levels of academic pressure.
Technical SummaryWe will investigate the association between academic pressure and mental health problems in secondary-school adolescents. We will focus on 14- to 16-year-olds. Adolescents at this age typically take âhigh-stakesâ GCSE exams and tend to experience higher levels of academic pressure. Our objectives are to describe rates of clinical presentations for depression, anxiety, and self-harm for each calendar month, and to test for differences between calendar months. We hypothesise that clinical presentations will be highest in months of exams (May and June).
We will describe incidence of clinical presentations for depression, anxiety, and self-harm for each calendar month, based on CPRD diagnoses, symptoms, and prescriptions (depression, anxiety) and HES admissions (self-harm). We will then test our hypothesis that rates are highest in months of GCSE exams. First, we will test for differences in incidence rates between calendar months, using Poisson regression. Second, we will use the self-controlled case series method (Petersen et al., 2016) to test whether adolescents are more likely to have presented in months when they were exposed (May, June) than when they were unexposed (all other months). We will run interactions/sub-group analyses for sex, month of birth, country, and calendar year. We will also investigate ADHD diagnoses and prescriptions as secondary outcomes, as these may also be affected by academic pressure. We will investigate the impact of educational policies that may have affected academic pressure related to GCSE exams. Finally, we will investigate whether associations may be different for years when exams were cancelled due to the Covid-19 pandemic (2020, 2021).
Mental health problems are a public health priority. They often start in adolescence, and academic pressure may play a role. We are aiming to add evidence that could inform the prevention of mental health problems. Our findings could inform policies related to GCSE exams or school interventions.
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Exploring the risk of cardioMetabolic complications and describing healthcare resource utilisation in PeOple living With ovERweight and obesity: a non-interventional retrospective longitudinal study in the UK. (EMPOWER) — Nikolaos Fragkas ...
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Exploring the risk of cardioMetabolic complications and describing healthcare resource utilisation in PeOple living With ovERweight and obesity: a non-interventional retrospective longitudinal study in the UK. (EMPOWER)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-30
Organisations:
Nikolaos Fragkas - Chief Investigator - Pfizer Ltd - UK
Nick Denholm - Corresponding Applicant - Harvey Walsh Ltd
Bethany Levick - Collaborator - Harvey Walsh Ltd
Hannah Matthews - Collaborator - Harvey Walsh Ltd
Joseph Hickey - Collaborator - OPEN Health Group
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Thozhukat Sathyapalan - Collaborator - University Of Hull
Xiaocong Marston - Collaborator - Harvey Walsh LtdOutcomes:
Baseline comorbidities , metabolic conditions (type 2 diabetes, dyslipidaemia, hypertension, coronary heart disease, and non-alcoholic fatty liver disease), mortality, weight loss interventions, inpatient admissions and length of stay, outpatient appointments, Accident and Emergency (A&E) attendances, primary care consultations, prescriptions, changes in obesity classes.
Description: Lay Summary
Obesity is a major public health challenge that affects almost every country in the world. People living with obesity are at increased risk of metabolic conditions, such as diabetes, hyperlipidaemia, hypertension, coronary heart disease, and non-alcoholic fatty liver disease. These metabolic conditions are known to be associated with increased mortality and increased healthcare resource utilisation (HCRU) and costs. The risk of developing metabolic conditions and associated HCRU and costs increase with body mass index (BMI). We propose this study to understand people in England living with high BMI (i.e., Class I, Class II, and Class III obesity) who have not developed metabolic conditions (i.e., metabolically healthy obesity). Specifically, we will investigate patient characteristics, clinical conditions, the risk of developing metabolic conditions and mortality, and HCRU and associated costs in this population and compare between those with normal BMI and people who were overweight (but not obese).
Technical Summary
Given the prevalence of obesity, it is of public health interest to understand the characteristics of this population and associated burden on the National Health Service in England, and to evaluate their risk of developing other severe diseases in the real-world.Global estimates suggest that almost 2.3 billion children and adults are living with overweight and obesity. The number of people living with obesity globally has increased substantially over the past few decades. The WHO released in May 2022 a report on the state of the obesity pandemic, stating that 60% of citizens in Europe are either overweight or obese, and highlighting the implications of the obesity pandemic. People living with obesity are at increased risk of metabolic conditions, including type 2 diabetes, dyslipidaemia, hypertension, coronary heart disease, and non-alcoholic fatty liver disease. People with obesity are also at risk of having multiple comorbidities, which are associated with mortality and increased HCRU and costs. The risk of developing metabolic conditions, associated HCRU and costs increase with BMI.
This study aims to understand the characteristics of people living with different obesity classes (I, II, and III) who are metabolically healthy, the risk of developing metabolic conditions and mortality, weight loss interventions and associated HCRU and costs in both primary and secondary care settings. Changes in obesity class will be investigated amongst a subgroup of children who turned into adulthood during the study period. Propensity-score-based inverse probability of treatment weighting (IPTW) will be used to estimate the differences between people in different obesity classes in the presence of confounding factors. Descriptive analysis will be conducted for all study outcomes. Cox proportional hazard models will be used to compare the risks of developing metabolic conditions among people in different obesity classes.
The results will provide insight into the importance of weight loss interventions in a metabolically healthy obese population and the associated benefit on the NHS in England. The knowledge is of public health interest and will allow understanding of the real-world value of weight loss interventions for obese people before developing metabolic conditions.
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Gabapentinoids and the risk of severe exacerbation in Chronic Obstructive Pulmonary Disease — Samy Suissa ...
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Gabapentinoids and the risk of severe exacerbation in Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-28
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Corresponding Applicant - McGill University
Omotayo Olaoye - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The primary outcome will be severe COPD exacerbation.
The secondary outcome will be respiratory failure.
Description: Lay Summary
Gabapentinoids, including gabapentin and pregabalin are medications used to treat seizures, anxiety and pain caused by nerve damage. Recently, their prescription has increased in North America and Europe, partly due to use for unapproved indications. However, these medications are ineffective for many unapproved uses and can cause serious adverse effects, including sleepiness and respiratory problems. Breathing difficulties have been reported in some patients using gabapentinoids, raising concerns for those with respiratory diseases like chronic obstructive pulmonary disease (COPD), who are at higher risk. Several health agencies have warned about the potential respiratory risks associated with gabapentinoids, especially in patients with COPD. However, there is no population-based study investigating these effects in patients with COPD. Thus, the main objective of our study is to assess whether gabapentinoid use is associated with severe COPD episodes among patients with COPD. We will form two groups of patients with COPD, one group comprising gabapentinoid users and the other group with non-users. We will compare the number of patients who have severe COPD episodes during follow-up among gabapentinoids users versus non-users. We will also study the difference according to the duration of use, age, sex, and COPD severity. This study will provide important information to guide gabapentinoid use in patients with COPD.
Technical SummaryGabapentinoids are indicated for the treatment of epilepsy, neuropathic pain and generalized anxiety disorder. Despite surging off-label use in Europe and North America, gabapentinoids are ineffective for many off-label indications while posing potentially severe adverse effects like central nervous system (CNS) depression, sedation, and respiratory depression. Case reports and prior studies have also reported severe respiratory difficulties associated with gabapentinoid use. Patients with COPD are of specific concern due to their increased susceptibility to adverse respiratory events amid the high prevalence of pain-related diagnoses and frequent analgesic use in this population. Regulatory agencies have issued warnings about the potential respiratory risks associated with gabapentinoids, especially in patients with COPD, yet no population-based study has investigated gabapentinoid-related respiratory adverse effects in this population. We will conduct a population-based cohort study to assess whether gabapentinoid use is associated with severe exacerbation among patients with COPD. Within a base cohort of all patients in the CPRD, newly diagnosed with COPD between 1993 and 2021, we will identify patients initiating gabapentinoids during follow-up, matched 1:1 on time-conditional propensity scores to non-users. Using the Poisson distribution, we will estimate crude incidence rates and 95% confidence intervals (CIs) for severe COPD exacerbation in each exposure group. We will use Cox proportional hazards models to estimate the hazard ratio and 95% CI for severe exacerbation associated with gabapentinoid use versus non-use. In secondary analyses, we will assess whether the risk varies with the duration of gabapentinoid use, age, sex, and COPD severity. Sensitivity analyses will be performed to assess the robustness of our results.
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Suicide risk assessment in primary care attenders using big data from general practice — Irene Petersen ...
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Suicide risk assessment in primary care attenders using big data from general practice
Datasets:GP data, Death from suicide.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-17
Organisations:
Irene Petersen - Chief Investigator - University College London ( UCL )
James Bailey - Corresponding Applicant - University College London ( UCL )
Irene Petersen - Collaborator - University College London ( UCL )
Irwin Nazareth - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Natalie Fitzpatrick - Collaborator - University College London ( UCL )
Patricia Schartau - Collaborator - University College London ( UCL )
Seena Fazel - Collaborator - University of OxfordOutcomes:
Death from suicide.
Description: Lay Summary
Suicide is a leading cause of death globally. People who develop mental health conditions or suicidal thoughts are at higher risk of dying from suicide and will often seek help from their general practitioner (GP). Part of the role of the GP in this situation is to think about who is most at risk of suicide. One reason this is difficult is that only a small number of people with thoughts of suicide act on them. Another is that there is no accurate tool to help show what makes someone higher risk than another. Finding a way to accurately predict which people are most at risk of dying from suicide could result in them getting the help they need sooner, and potentially prevent these deaths.â¯
Though the risk factors for suicide have been well studied in people who are under the care of mental health teams or who have harmed themselves in the past there is not much research looking at the risk factors for people who are under the care of their GP. Only a quarter of people who die from suicide have seen a psychiatrist in the year before their death, compared to 9 out of 10 people who have seen their GP. By exploring what factors make people who see their GP about their mental health more likely to die from suicide we hope to inform GPâs assessment of suicide risk and see which combination of risk factors can best predict who is most likely to die.
Technical SummaryObjective
To improve our understanding of suicide risk in primary care attenders.Primary outcome
Suicide will be defined as a recording of death by self-injury on the linked Office for National Statistics (ONS) Death Registry using ICD-10 codes X60-X84 âIntentional self-harm and event of undetermined intent" or Y87.0 âsequelae of intentional self-harmâ.Primary exposures
We have chosen a list of exposures a priori from a literature review of risk factors and discussion between co-authors who have a range of clinical and epidemiological backgrounds.Study design
This study will have a cohort design.Methods
Methods will compare regression (Cox Proportional Hazards for time to event and linear regression for risk) models to a range of machine learning techniques to produce predictive models for suicide. The machine learning models currently planned will be random forest and neural networks however this is a rapidly changing field and we are currently considering the use of ensemble techniques. Classification trees will be used to look for novel risk factors.Linked data
To establish hospital admissions for self-harm and outpatient appointments linked Hospital Episode Statistics (HES) outpatient data will be used. Index of Multiple Deprivation linkages will be used to establish the impact of deprivation on risk. ONS Death Registry data will be used to define the outcome as well as being used to validate the cause of death being recorded as suicide in the core CPRD dataset.
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Health inequalities in People with seveRe mental Illnesses: Impact of antipsychOtic tReatments and social Inequalities on long Term phYsical health (PRIORITY). — Juan Carlos Bazo Alvarez ...
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Health inequalities in People with seveRe mental Illnesses: Impact of antipsychOtic tReatments and social Inequalities on long Term phYsical health (PRIORITY).
Datasets:GP data, CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-22
Organisations:
Juan Carlos Bazo Alvarez - Chief Investigator - University College London ( UCL )
Juan Carlos Bazo Alvarez - Corresponding Applicant - University College London ( UCL )
Irene Petersen - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Natalie Fitzpatrick - Collaborator - University College London ( UCL )Outcomes:
Intermediate outcomes: a change in low-density lipoprotein cholesterol (LDL-C); systolic blood pressure (BP); glycated haemoglobin (HbA1c); weight over time.
Final outcomes: first event after treatment initiation of antipsychotics of cardiovascular disease (CVD); type-2 diabetes mellitus (T2DM); and all-cause mortality.Description: Lay Summary
Individuals with severe mental illnesses face a higher risk of developing conditions such as diabetes (sugar in the blood) and heart disease (e.g., heart attacks). Consequently, they tend to live shorter lives, on average 10 to 15 years less than those without these mental health challenges. To manage their conditions, they are often prescribed antipsychotic medications for extended periods. When used over long periods, these medications can lead to weight gain and changes in blood pressure and cholesterol levels (unhealthy fat in the blood). These effects may partly contribute to the increased risk of diabetes and heart disease in this group.
My goal is to investigate how the use of antipsychotic medications impacts the physical health of individuals with severe mental illnesses and how this impact may vary depending on factors like age, gender, ethnicity, and socioeconomic status. By analysing data routinely collected in general practices from over 200,000 patients, I will study the patterns of antipsychotic medication use over nearly two decades (2000-2019). I will then compare their body weight, blood pressure, and cholesterol levels before and after starting antipsychotic treatment to understand the long-term effects on physical health. Additionally, I will explore how prescription patterns (e.g., changes in doses over time) and their effects on physical health may differ among different age groups, genders, socioeconomic backgrounds, and ethnicities.
The insights gained will provide valuable information to patients and their healthcare providers, helping them better comprehend the long-term effects of antipsychotic medications and guiding future treatment decisions.
Technical SummaryPeople with severe mental illnesses (SMI) have reduced life expectancy and a higher risk of developing type-2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). I aim to examine health inequalities in terms of 1) long-term antipsychotic treatment patterns and how these vary across groups by age, gender deprivation and ethnicity; 2) relationship between long-term antipsychotic treatment and the change of HbA1c, weight, blood pressure and cholesterol over time (health indicators); 3) based on this long-term association, determine the relationship between antipsychotic treatment and the risk of developing T2DM, CVD, and all-cause mortality, and how inequalities by socio-demographics might influence this pathway. Findings will be reported for England and each area identified by the NIHR 'heat map' as being underserved in terms of mental health research. I will use primary care data on individuals aged 18-99 observed 2000-2019 who were prescribed antipsychotics. I will apply machine learning (ML) techniques to identify treatment patterns linked to specific sociodemographic groups. I will fit multivariate mixed-effects models for the interrupted time series (ITS) analysis of health indicators trajectories over time, before and after antipsychotic treatment initiation, jointly with survival models to estimate the risk of developing T2DM, CVD and mortality, stratified by socio-demographics. ML results will help identify inequalities in long-term treatment prescriptions across sociodemographic groups, including most deprived and ethnic minority groups and providing new evidence for underserved regions in England. Results from ITS will inform doctors and people-with-SMI decisions on long-term treatment, which will be able to consider evidence from minority and most deprived groups typically underrepresented in mental health research.
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Incidence, prevalence, treatment and natural history of autoimmune diseases in England: a population-based cohort study — Daniel Prieto...
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Incidence, prevalence, treatment and natural history of autoimmune diseases in England: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-09
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Albert Prats Uribe - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Francesco Dernie - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
1. Individuals with selected autoimmune diseases
2. Baseline characteristics of individuals diagnosed with selected autoimmune diseases
3. Mortality rates of individuals with selected autoimmune diseases
4. Tests and measurements performed to individuals with the selected autoimmune diseases
5. Rates of complications associated with the selected autoimmune disease (e.g venous thromboembolism in individuals with antiphospholipid syndrome)
6. Exposure to pre-specified drugs and sequence of drugs used for treatment of the selected autoimmune diseaseDescription: Lay Summary
Autoimmune diseases occur when the bodyâs own immune system cause damage to tissues and organs. A wide range of autoimmune diseases exist, and these vary in the body systems they affect, the symptoms and signs patients present with, and their long-term effects. The number and percentage of population affected by autoimmune diseases are thought to be increasing, but up-to-date estimates of these have been lacking. A recent study focussed on the 19 most common autoimmune diseases. They used data from the CPRD database to calculate their findings and found that in general the incidence of these diseases is indeed rising.
In our study, we aim to calculate the incidence and prevalence of other autoimmune disease which were not included in the study above. While these may be less common, it is nevertheless useful to have up to date estimates of these diseases in order to help guide public health policy and service planning in the national health service (NHS) for patients with these conditions. We also want to examine the complications associated with these diseases, what tests lead to their diagnosis, and the drugs used to treat these diseases.
Technical SummaryNHS GP records provide a unique source of data which can be used for estimating the incidence and prevalence of health conditions, including autoimmune diseases. We aim to use CPRD data mapped to the OMOP Common Data Model (CDM) to estimate the incidence and prevalence of selected autoimmune diseases, and the mortality associated with the diseases.
Study design
Population-based cohort studyPopulation
All individuals within the CPRD GOLD database will be initially eligible in the selection period which will be 01/01/2000 to end of data visibility. Individuals with >=1 year (365 days) of prior history prior to first diagnosis of the selected autoimmune disease will be eligible, with sensitivity analyses using different prior history requirements.Variables
- We will use SNOMED codes in OMOP-mapped data to create a cohort of individuals with the selected autoimmune disease of interest
- Exposure to pre-specified list of treatments for the selected autoimmune condition of interest
- Development of one of a pre-specified list of complications related to the selected autoimmune condition of interestAnalyses
Individuals with the disease of interest will be characterised at the time of first diagnosis. Point prevalence and incidence will be estimated. Analyses will be stratified by age, sex, ethnicity, region, and calendar month/year. The number and percentage of patients receiving each of a pre-specified list of treatments for their condition will be described per calendar year, and exposures to each medication type will be described.
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The treatment pathway for Atrial Fibrillation from diagnosis to ablation; including the influence of socioeconomic factors on access to ablation in England — Karine Szwarcensztein ...
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The treatment pathway for Atrial Fibrillation from diagnosis to ablation; including the influence of socioeconomic factors on access to ablation in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-24
Organisations:
Karine Szwarcensztein - Chief Investigator - Johnson & Johnson Medical SAS
Cindy Tong - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Anirban Pal - Collaborator - Mu SIgmaOutcomes:
Outcome 1: Ratio of number of patients who had ablation in 24 months after first AF diagnosis, compared to those who are defined as eligible;
Outcome 2: Proportion of patients who followed each AF care pathway that has been mapped;
Outcome 3: Time between defined steps of the AF care pathway;
Outcome 4: Differences for the above outcomes based on demographic and socioeconomic factorsDescription: Lay Summary
Atrial fibrillation (AF) is a common heart condition where normal heart rate is disrupted. It affects around 1.5 million people in England, and if left untreated can lead to serious complications, including stroke and heart failure.
Initially, medication is prescribed to manage the symptoms, but if this fails, a procedure called âablationâ is recommended. Compared to other countries, the number of patients receiving ablation in England is lower than expected. This is concerning as symptoms can worsen over time, become more difficult to treat and reduce quality of life for patients.
This study aims to understand why ablation numbers are low, by observing:
In how many AF patients have drug treatments failed to control symptoms (so should be considered for ablation).
How many patients are referred to specialist heart doctors.
How long it takes from diagnosis of AF to receiving ablation.
If where a patient lives and their age or gender is associated with receiving ablation.
If the COVID-19 pandemic impacted waiting times for ablation.By conducting this research, we aim to describe the current AF treatment pathway and to uncover potential barriers limiting access to ablation. We hope a publication would empower clinicians and patient groups to demand that policy makers a) prioritise AF generally and b) improve/standardise access to ablation for all patients who could benefit. With an overarching aim to improve AF symptom control, enhance the quality of life for the patient, avoid AF associated complications and reduce the overall burden of AF on the healthcare system.
Technical SummaryAF is the most common sustained cardiac arrhythmia worldwide, with 1.5 million expected cases in England. It is a progressive disease and confers an increased risk of stroke, heart failure, cognitive decline, and death. Ablation is a procedure to treat AF which is recommended for use when drug treatment fails to control the condition. Increasing evidence is showing that early restoration of a normal heart rhythm is important for patients with AF. However, despite a 72% increase (202,333 vs. 117,880) in the number of AF diagnoses from 1998 to 2017, since 2016 the numbers of catheter ablations have remained constant. Furthermore, only 121,444 ablation procedures were administered since 2014 in England and Wales with the COVID-19 pandemic compounding these effects.
Using CPRD GOLD and Hospital Episode Statistic (HES) data, this study will explore if eligible patients are able to access ablation as per the guidelines in England. The study cohort will include patients with an AF diagnosis in the study period and at least 24 months of follow-up data. The ratio between the number of patients eligible to receive ablation compared to the number of patients who had ablation will be calculated. Potential steps in the AF care pathway were identified by reviewing guidelines (NICE, ESC and NHS). The various care pathways from AF diagnosis to the end of study period, using the pre-identified steps, will be mapped for each patient. Proportion of patients for each care pathway defined will then be summarized. Percent of patients and time between steps of the care pathways will be described. Potential disparities in access will be examined by evaluating different pre-specified subgroups of patients. This study aims to highlight areas of improvement, in turn to help the NHS, government officials and local commissioners shape AF treatment and ablation policies.
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Development and validation of cardiovascular and mortality risk scores for haemodialysis patients using statistical and machine learning techniques — Anirudh Rao ...
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Development and validation of cardiovascular and mortality risk scores for haemodialysis patients using statistical and machine learning techniques
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-13
Organisations:
Anirudh Rao - Chief Investigator - University of Liverpool
Anirudh Rao - Corresponding Applicant - University of Liverpool
Ivan Olier - Collaborator - University of Liverpool
Sandra Ortega-Martorell - Collaborator - University of LiverpoolOutcomes:
The primary outcome will be the prediction of incident Major Adverse Cardiovascular Events (MACE). MACE will be defined as the composite of total death, myocardial infarction, coronary revascularisation, stroke, and hospitalisation because of heart failure.
The secondary outcome will be the prediction of incident cardiovascular disease. Incident cardiovascular disease will be defined as heart failure, angina pectoris, acute myocardial infarction, coronary artery revascularisation, ischemic heart disease, atraumatic stroke, and transient ischemic attack.
Description: Lay Summary
End-stage kidney failure (ESKD) is the final, permanent stage of chronic kidney disease (CKD), where kidney function has worsened to the point that the kidneys can no longer function independently. At this stage, dialysis is required to remove waste products and excess fluid from the blood. There are two types of dialysis. In haemodialysis (HD), blood is pumped out of the body to an artificial kidney machine and returned to the body by tubes that connect a person to the machine. In peritoneal dialysis (PD), the inside lining of the belly acts as a natural filter.
PD has the advantage of being gentler on the heart. HD causes significant stress to the heart by reducing the blood flow to the heart muscle, resulting in heart failure, irregular rhythms, and eventually sudden heart death. A large study showed that patients receiving HD were 48% less likely to live in the first two years than PD patients, related to heart problems such as heart attacks, heart failure and stroke.
The purpose of this database study is to use a mathematical process to predict future heart events by analysing patterns in the data to highlight factors associated with the development of heart disease in patients commencing HD compared with patients on PD.
Technical SummaryIn ESKD, cardiovascular (CV) complications, are the leading cause of death. CKD/ESKD is a systemic proinflammatory state contributing to vascular and myocardial remodelling, atherosclerosis, vascular calcification, cardiac fibrosis and complex dyslipidaemia, mimicking accelerated ageing of the cardiovascular system.
Haemodialysis (HD) compensates for the loss of renal function in most ESKD patients (95%). HD sessions exert significant hemodynamic effects, with 20â30% of them complicated by significant intradialytic hypotension. HD reduces coronary blood flow and leads to myocardial ischemia, which leads to myocardial functional and structural changes. HD is associated with more cardiovascular complications than peritoneal dialysis (PD) and (10-20-fold) excess CV morbidity and mortality compared to the general population.
The Framingham Heart Study score was designed to derive ten-year CV risk in the general population. However, applying this score to assess CV risk in haemodialysis patients may not be appropriate as several traditional risk factors for CV disease in the general population (e.g. elevated serum cholesterol or Body Mass Index (BMI)) are not related to CV mortality in advanced CKD. There are currently no clinically established prognostic models in clinical practice to stratify CV risk in HD patients.
The study aims to develop a risk prediction tool for incident MACE (Major Adverse Cardiovascular Events) in patients on haemodialysis compared with peritoneal dialysis patients and advanced CKD, using readily available clinical data. The study aims to compare the MACE burden in patients starting haemodialysis, peritoneal dialysis, and advanced CKD (stages 3b and 4), and use this data to build and validate a clinical prediction model in the Clinical Practice Research Datalink database.
This study intends to use and compare in terms of prediction ability a range of statistical and advanced machine learning (ML) models, such as multiple logistic regression (MLR), artificial neural networks (ANN), random forest (RF), and gradient boosting machines (GBM).
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Health outcomes of children with rare or complex diseases and their families: a descriptive longitudinal cohort study — Pia Hardelid ...
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Health outcomes of children with rare or complex diseases and their families: a descriptive longitudinal cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD GOLD Ethnicity Record; CPRD GOLD Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-23
Organisations:
Pia Hardelid - Chief Investigator - University College London ( UCL )
Joachim Tan - Corresponding Applicant - University College London ( UCL )
Ania Zylbersztejn - Collaborator - University College London ( UCL )
Linda Wijlaars - Collaborator - University College London ( UCL )
Paolo De Coppi - Collaborator - University College London ( UCL )
Paul Gissen - Collaborator - University College London ( UCL )Outcomes:
Objective 1: prevalence of RCDs:
Prevalence of major congenital anomalies (MCAs) (overall and by subgroup);
Prevalence of conditions included the newborn blood spot screening (NBS) programme in the UK (overall and by subgroup);
Objectives 2 and 4: health of children with RCDs and their siblings:
Primary: incidence of co-existing mental health or chronic conditions; rates of primary care consultations, hospital admissions (overall, planned, unplanned);
Secondary: rates of prescriptions in primary care, cause-specific primary care consultations and hospital admissions, hospital outpatient consultations, A&E attendances; rates of all-cause and cause-specific mortality
Objective 3: health of mothers:
Primary: incidence of mental illness; rates of primary care consultations;
Secondary: rates of prescriptions in primary care, cause-specific primary care consultations; referral to secondary or specialist care
Description: Lay Summary
About 2% of babies are born with a major birth defect, where one or more body organs fail to develop or function properly. Some inherited conditions are less visible at birth (and are screened for in newborn babies) but if untreated they can disrupt organ function or metabolism and lead to serious illness. These rare and complex diseases are a major cause of early death or long-term illness and disability. Children with these conditions are more likely to require specialised medical services and have frequent contact with healthcare services than other children. Caring and seeking support from services for a child with a rare or complex disease can be a major source of stress for parents, contributing to development of mental and physical health problems. We also know little about the impact on siblings.
Our study aims to describe the health experiences of children with birth defects or rare diseases that newborns are screened for and determine how these vary according to sex, ethnicity, area deprivation and UK region. We will compare their outcomes with those of their peers, such as other children registered in the same GP practices. We will also link the records of children and their mothers and siblings, to look at the health of family members. The studyâs findings will inform policies to support children with complex health needs as well as their families, to improve their overall wellbeing through childhood to early adulthood.
Technical SummaryRare or complex diseases (RCDs) in children are frequently present at birth and have serious health, functional and social consequences for affected individuals. We aim to describe the mental and physical health of children with RCDs and their families in England. We focus on two groups of conditions present from birth: major congenital anomalies (MCAs); and serious inherited conditions that are screened for in newborns (e.g. sickle cell or cystic fibrosis).
We will analyse linked data from the Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES), ONS mortality, Mother-Baby Link (MBL), Index of Multiple Deprivation (IMD) and CPRD Ethnicity Records. We describe the prevalence of RCDs in HES, ONS and CPRD using a longitudinal cohort of children born between 2002-2022 (or latest available). We will compare health outcomes (mental health, chronic conditions, death) and rates of healthcare contacts (GP visits, prescriptions, secondary healthcare interactions) in children with RCDs and their unaffected peers. We will investigate variation in these outcomes by socio-demographic and geographical factors.
We will describe the health of mothers and siblings using MBL to understand the broader impact of childhood diseases on families. We will describe the incidence of mental and physical health problems and indicators of stress and ill-health in mothers of children with and without RCDs. We will describe the health outcomes of siblings (indicated by other children linked to the same mother).
We will estimate incidence rate ratios using Poisson/negative binomial regression and odds/risk ratios using logistic/log-binomial regression. Cox proportional hazards models will be used to examine factors associated with survival and diagnosis of chronic conditions.
Our findings will provide important prognostic information for families/carers and healthcare professionals working with children with RCDs, and guide the planning of support and services for growing population of children with RCDs.
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Clinical characteristics, outcomes and disease trajectories for patients with incident atrial fibrillation — Jianhua Wu ...
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Clinical characteristics, outcomes and disease trajectories for patients with incident atrial fibrillation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-30
Organisations:
Jianhua Wu - Chief Investigator - Queen Mary University of London
Harriet Larvin - Corresponding Applicant - Queen Mary University of London
Chris Gale - Collaborator - University of Leeds
Lan Mu - Collaborator - Queen Mary University of London
Paris Baptiste - Collaborator - Queen Mary University of London
Ramesh Nadarajah - Collaborator - University of LeedsOutcomes:
Cardiovascular and non-cardiovascular related hospital admission; atrial fibrillation incidence; all-cause and cause specific mortality; surgical procedures; oral anticoagulation prescriptions
Major cardiovascular outcomes including stroke; heart attack; ischemic heart disease; heart failure and all-cause mortality.
Non-cardiovascular outcomes including pneumonia; renal failure; liver disease; cancer; dementia; cause-specific mortality.Description: Lay Summary
Atrial fibrillation (AF) is a condition that causes an irregular and often abnormally fast heartbeat. It is common and can cause further problems and development of other diseases including heart failure.
Technical Summary
Whilst AF is common, it is often diagnosed too late â only after complications and hospitalisation has occurred. There are still uncertainties about who gets AF and why, and which health conditions people with AF are likely to develop later in life.
In this research we will use hospital and primary care medical records to see if we are able to predict who is likely to get AF, and to look at what happens to patients diagnosed with AF in the long term. We will study patientâs information such as age and gender, as well as their medical history to determine how these may be associated with developing AF. We will also study the pharmaceutical and surgical treatments used to treat AF and compare how different treatments can impact long term risks of further disease. The research will use traditional statistical methods as well as artificial intelligence to try and answer these questions. The findings of this research will help understand how AF is linked to other conditions and show the benefit of diagnosing and treating AF to stop further disease development.Atrial fibrillation (AF) is a common, chronic condition that incurs substantial health-care expenditure.
Many patients with AF are diagnosed too late and once stroke has occurred. There is a fundamental knowledge gap in prediction of for whom and when new onset AF will occur; if filled this could transform the outcomes of patients with AF. Equally, little is known about the full health burden of AF â beyond that of hypothesis-driven clinical outcomes. Oral anticoagulation (OAC) can be given to patients with AF for stroke prevention, however uptake is limited. Surgical intervention can alleviate AF and associated outcomes but longitudinal studies with long-term follow up are scarce and the comparative effects of OAC are unclear.
There is a dearth in largescale population-based studies that provide high-resolution insights into the effects of AF treatment, and the risk factors and disease trajectories of patients with AF. Using CPRD GOLD and Aurum primary care data linked with ONS mortality, HES-APC and index of multiple deprivation, this study aims to investigate the clinical pathways of AF patients across three objectives:
1. To assess the risk factors of AF using cox proportional hazard regression model and survival random forest analysis, and identify multimorbidity clusters for patients with AF using hypergraphs network analysis.
2. To determine disease trajectories following the diagnosis of AF using process mining, and quantify the disease pathways amongst AF patients compared with the general population using flexible parametric relative survival models.
3. To investigate the use of OAC and surgical intervention for stroke prophylaxis in patients with AF, and quantify their association with major cardiovascular and non-cardiovascular outcomes using multivariable survival models.
This study will help target therapeutic strategies to specific patient groups and detect the high-risk individuals for AF prevention.
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The safety of beta-blockers in Chronic Obstructive Pulmonary Disease (COPD): A prevalent new-user cohort study — Samy Suissa ...
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The safety of beta-blockers in Chronic Obstructive Pulmonary Disease (COPD): A prevalent new-user cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-15
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
All-cause mortality; Severe COPD exacerbation
Description: Lay Summary
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease characterized by increasing breathlessness that worsens over time. COPD is a major cause of disability and has become the third cause of death globally. Treatments attempt to prevent or delay acute exacerbations of COPD that contribute to worsen the disease over time and are associated with increased mortality. There is no cure and treatments revolve around symptom relief and controlling the inflammation from the disease. The current treatments, that include bronchodilators and inhaled corticosteroids, have been available for a long time with no new effective treatments. A large proportion of patients with COPD also have cardiovascular disease (CVD), such as myocardial infarction, stroke, or heart failure, etc. Both diseases share common risk factors such as smoking, increased age and decreased physical activity. Beta-blockers are old drugs that are effective for cardiovascular disease and have been suggested as potentially useful to improve outcomes in patients with COPD. A large trial found that this was not the case and suggested a possible increased mortality with beta-blockers in these patients. Our study will investigate whether beta-blockers used in patients with COPD increases the risk of death. This study will inform clinical recommendations on how to reduce harm and improve major outcomes for COPD patients worldwide.
Technical SummaryThe objective of this study is to evaluate the safety of beta-blocker use on the risk of death in patients with COPD. We will use the Clinical Practice Research Datalink (CPRD) to form a base cohort of patients with a COPD diagnosis, aged 55 or over, and treated with long-acting bronchodilators. We will use a prevalent new-user design to define the study cohort, whereby for each patient who initiates beta-blockers during follow-up, a time-conditional propensity score-matched reference subject, unexposed to beta-blockers, will be selected from the corresponding exposure set of patients with the same time since cohort entry, with the same indication for the beta-blocker, and with a visit to a physician at the time of the exposure set. Thus, the time span between base cohort entry and study cohort entry is inherently a matching covariate. Time-conditional propensity scores will be estimated using all relevant covariates, measured from diagnoses, procedures, and medications in the one-year period prior to the date of the matched set and applying conditional logistic regression. The matched subjects in the study cohort will be followed for one year from cohort entry, date of death, September 2023, or the end of coverage in the practice, whichever is first. The primary outcome is all-cause mortality while the secondary outcome is the first severe COPD exacerbation to occur after cohort entry, defined as a hospitalization for COPD as primary cause. For secondary outcome of severe COPD exacerbation, follow-up will end in March 2021, last date of availability (HES database). The comparative analysis of time to death and time to the first severe exacerbation within one year will use a Cox proportional hazard regression model to perform an as-treated analysis to estimate the hazard ratio of COPD exacerbation and mortality with current use of beta-blocker, also according to indication.
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Valvular Heart Disease Diagnosis and Treatment Rates in the UK — Marcella Kelley ...
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Valvular Heart Disease Diagnosis and Treatment Rates in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-02
Organisations:
Marcella Kelley - Chief Investigator - Edwards Lifesciences Corp. ( USA )
Marcella Kelley - Corresponding Applicant - Edwards Lifesciences Corp. ( USA )
Alissa Dratch - Collaborator - Edwards Lifesciences Corp. ( USA )
Anant Shanbhag - Collaborator - Edwards Lifesciences Corp. ( USA )
Christin Thompson - Collaborator - Edwards Lifesciences Corp. ( USA )
Godfred Marfo - Collaborator - Edwards Lifesciences Corp. ( USA )
Jose Benuzillo - Collaborator - Edwards Lifesciences Corp. ( USA )
Lisa Kemp - Collaborator - Edwards Lifesciences Corp. ( USA )
Michael Ryan - Collaborator - Edwards Lifesciences Corp. ( USA )
Rachele Busca - Collaborator - Edwards Lifesciences SA ( Switzerland )
Shannon Murphy - Collaborator - Edwards Lifesciences Corp. ( USA )
Soumya Chikermane - Collaborator - Edwards Lifesciences Corp. ( USA )
Stephanie Toney - Collaborator - Edwards Lifesciences Corp. ( USA )
Xiayu Jiao - Collaborator - Edwards Lifesciences Corp. ( USA )Outcomes:
Primary: Number of people with valvular heart disease (e.g., stenosis or regurgitation of the aortic, mitral, tricuspid, or pulmonic valves); Prevalence of surgical and transcatheter repair and replacement for the four heart valves (e.g., surgical aortic valve replacement, transcatheter aortic valve replacement, surgical mitral valve replacement, transcatheter edge to edge repair); Mortality (e.g., in-hospital, all-cause mortality, cardiovascular); Healthcare resource utilization (e.g., hospitalizations, outpatient visits, hospital readmissions, reintervention); Number of people with heart failure hospitalizations; Number of HF patients with valvular heart disease symptoms
Secondary: Time from diagnosis to treatment; Procedure characteristics (e.g., admission methods, transcatheter or surgical, waiting times); Length of stay during procedure hospitalization; Admission to the intensive care unit; Prevalence of concomitant procedures (e.g., coronary bypass graft); Risk of percutaneous coronary intervention; Conversion to surgery in case of a transcatheter intervention; Destination at discharge; Prevalence of complications following procedure (e.g., acute kidney infection, atrial fibrillation, disabling stroke, bleeding); Time to hospital readmission and reason for hospital readmission (i.e., diagnosis codes, reoperation)
Description: Lay Summary
Heart failure and valvular heart diseases, such as aortic stenosis, mitral regurgitation, tricuspid regurgitation, and pulmonary diseases, are leading causes of heart-related illnesses and death. Despite the availability and effectiveness of treatments, many patients, particularly elderly patients, with valvular heart disease (VHD) are left undiagnosed and/or untreated. In a UK cohort study, 12% of participants 75 years or older had previously undetected VHD, and the rate of undiagnosed was higher in areas with more socioeconomic deprivation. Since VHD is often undiagnosed and a frequent cause of heart failure, we will measure the frequency of VHD symptoms in a cohort of patients with heart failure. For one type of VHD, severe symptomatic aortic stenosis (ssAS), approximately 75% of ssAS patients 80 years or older in the United States do not receive treatment via aortic valve replacement. We seek to estimate the treatment rate for ssAS and other valvular heart disease conditions in the United Kingdom. Estimating the number of people with VHD, the number treated, and their associated health outcomes provides valuable information regarding the unmet treatment need and opportunities for improved outcomes among patients with valvular heart disease in the UK.
Technical SummaryThe aim of our study is to estimate the number of people with rheumatic or non-rheumatic VHD (e.g., stenosis or regurgitation of the aortic, mitral, tricuspid, or pulmonic valves), estimate the number treated, estimate the number of heart failure patients with VHD symptoms, study the patient pathway, and evaluate outcomes, accounting for patient demographics. Our study population is patients with valvular heart disease (VHD) or a heart failure (HF) hospitalization. VHD is defined either as a diagnosis of VHD in an inpatient or outpatient setting or receipt of a procedure for the treatment of VHD in an inpatient setting. Heart failure hospitalization is defined as a diagnosis of HF in an inpatient setting. Clinical Practice Research Datalink (CPRD) outpatient data and Hospital Episode Statistics (HES) data will be used to select the cohort and measures of interest. We will use descriptive statistics to describe patient and care characteristics for VHD and HF patients. Given the underdiagnosis of VHD, descriptive statistics of HF patients will inform the prevalence of VHD symptoms in this sample. In addition, this study aims to assess clinical and economic outcomes of VHD patients during the pre-, peri-, and post-treatment periods. We will run multivariate regressions to assess if treatment rates vary significantly by age group for each type of valvular heart disease, controlling for patient and practice characteristics. Additional models will be used to assess changes in other clinical and economic outcomes of interest, such as healthcare resource utilization, mortality, and procedure waiting time. Estimates will provide insight into the number of patients with valvular heart disease and treatment rates by subgroups. Understanding treatment rates and variation is a critical step to addressing the undertreatment of valvular heart disease and improving health outcomes, including survival.
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Drug utilization study in patients with major depressive disorder - a DARWIN EU study — Antonella Delmestri ...
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Drug utilization study in patients with major depressive disorder - a DARWIN EU study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-02
Organisations:
Antonella Delmestri - Chief Investigator - University of Oxford
Antonella Delmestri - Corresponding Applicant - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
This study will examine the following primary outcomes of interest.
⢠Treatment Initiation
Initiation of treatments will be assessed within a window of 4, 6, 8, 12, and 24 weeks following diagnosis. In relation to the outcome, a predefined list of MDD treatments will be compiled to address Objectives 1 and 3. MDD treatments will include NSRIs, SSRIs, other antidepressants, and concomitant drugs of interest (Psycholeptics - N05A, N05B, and N05C) as listed in Table 7 of the attachment.
⢠Treatment Switching
Switching of treatments will be assessed within a window of 4, 6, 8, 12, and 24 weeks following treatment initiation. In relation to the outcome, a predefined list of MDD treatments will be compiled to address Objectives 1 and 3. MDD treatments will include NSRIs, SSRIs, other antidepressants, and concomitant drugs of interest (Psycholeptics - N05A, N05B, and N05C) as listed in Appendix1 of the attachment.
⢠Treatment Discontinuation
Discontinuation of treatments will be assessed within a window of 4, 6, 8, 12, and 24 weeks following treatment initiation. In relation to the outcome, a predefined list of MDD treatments will be compiled to address Objectives 1 and 3. MDD treatments will include NSRIs, SSRIs, other antidepressants, and concomitant drugs of interest (Psycholeptics - N05A, N05B, and N05C) as listed in Appendix1 of the attachment.Description: Lay Summary
This study is about a severe mental illness called Major Depressive Disorder characterized by persistent low mood, low self-esteem, loss of interest or pleasure in normally enjoyable activities, and, in severe cases, suicidal thoughts. This illness affects around 2% of the European population and is growing fast. The management of this disease is complex and involves several types of interventions including pharmacological treatments. Despite therapeutic advancements, between 10% and 30% of patients show limited or no response to available medications, highlighting the need for novel therapeutic approaches.
Clinical trials play a crucial role in evaluating treatments, but more understanding is needed about events occurring in real life after the trials end. This study aims to fulfil this gap by providing valuable insights into primary care treatment initiation, switching, and discontinuation among patients newly diagnosed with this disease.
The European Medicines Agency has commissioned the Data Analysis and Real-World Interrogation Network (DARWIN) European Union (EU) centre to understand how this disease is treated in clinical practice in Europe. We will contribute to this network via federated analyses to give answers for affected patients.We will use data between 01/01/2013 and 31/12/2022 from Clinical Practice Research Datalink (CPRD) GOLD database to understand better affected patients in the UK, the prescription patterns used in clinical practice, and their effectiveness, together with risks and benefits.
This study has the potential to offer policy makers an informed baseline for the development of better guidelines focussed on improving everyday patient care and outcomes for this disease.
Technical SummaryBACKGROUND: Primary care records provide a unique source of data for estimating drug utilisation in the community. The DARWIN EU© initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making, and has requested a drug utilisation study on antidepressants and psycholeptics to study rates of occurrence of treatment-related intercurrent events in patients with major depressive disorder (MDD).
RATIONALE: In clinical trials involving patients with MDD, participants who start treatment may experience intercurrent events (IEs) during follow-up (e.g. treatment discontinuation, switch to alternative therapies, or changes in background/concomitant therapies). However it is still unclear if the rate of occurrence of these IEs in real-life settings is comparable to what is observed in the clinical trials: the results of this study aim to provide valuable information regarding the generalisability of clinical trial findings to real-world scenarios.STUDY DESIGN: Cohort study
POPULATION: All people in CPRD GOLD between 2013 and 2022 with at least 365 days of data availability before the day they become eligible for study inclusion.
CONDITION OF INTEREST: Major depressive disorder (MDD).
DRUGS OF INTEREST: antidepressants (NSRIs, SSRIs, or other anti-depressants) and psycholeptics (antipsychotics, anxiolytics, hypnotics, and sedatives)VARIABLES: Exposure to antidepressants and psycholeptics in a cohort of patients with a MDD diagnosis will be based on diagnoses and prescription data in CPRD GOLD [medical and product codes mapped to the OMOP Common Data Model].
ANALYSES:
1) Patient level characterisation for people with newly diagnosed MDD and assessment of the use patterns of the respective drugs of interest.
2) Summary descriptive statistics (mean, median, quantiles 25% and 75%, minimum and maximum) considering duration of antidepressant use for the first exposure episode of the respective antidepressant class of interest
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD) — Craig Allen ...
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-23
Organisations:
Craig Allen - Chief Investigator - MHRA
Craig Allen - Corresponding Applicant - MHRA
Jenny Wong - Collaborator - MHRAOutcomes:
Incidence of stroke among patients with epilepsy
Description: Lay Summary
Over the last few years, organisations who make data available for public health research have been looking for ways to improve data sharing and security among users of the data. One approach that has been recommended in the UK is the use of platforms which allow access to data so analysis can be performed but limited outputs (e.g. aggregated results) can be exported. CPRD are working to establish such a platform for its users. However, it is key that the platform still enables vital health research to be performed. To help assess this, a study looking at epilepsy and stroke will be conducted.
Epilepsy is the name for a group of chronic conditions which result in repeated seizures and affects people of all ages, genders and ethnicities. Epilepsy has been linked to other conditions, including stroke. However, studies in this area have been limited and not recent.
The aims of this study are to provide more updated information on the statistics of stroke in epileptic patients while also assessing if important research can be conducted in CPRDâS secure platform. As there is a drive for more organisations to use such platforms, this research will benefit public health by ensuring such methods do not hamper research using CPRD data.
Technical SummaryThe main aim of this study is to calculate the incidence of stroke among patients with epilepsy who were prescribed anti-seizure medication. This research will benefit public health by presenting an updated picture of the disease in the UK thus highlighting areas of improvement in the management of such patients and suggesting areas for further research.
This is a retrospective cohort study of epileptic patients prescribed anti-seizure medication with an incident record of stroke between 01/012010-31/12/2019 in their primary or secondary care data record.
The CPRD primary care data will be used for defining the study population. This will also be linked to the Hospital Episode Statistics Admitted Patient Care (HES APC) data (for defining the outcome of stroke), Office for National Statistics (ONS) Death Registration data (for defining the outcome of stroke and the date of death), and patient-level Index of Multiple Deprivation (IMD) data (as a covariate).
Descriptive results will be presented for patient demographics and incidence rates will also be calculated as the number of newly diagnosed stroke events in patients with epilepsy (numerator) divided by the sum of the person years of follow-up of epileptic patients during each calendar year of interest. The rates will be stratified by age group, gender, and year of stroke diagnosis.
The other aim of this study is to test the use of the CPRD's new secure platform or Trusted Research Environment (TRE) using this epilepsy study as an example to test it.
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Clinical Management and Outcomes in Prostate Cancer: Observational, Population-Based Standing Cohort Study in England — Maximiliaan Nievaart ...
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Clinical Management and Outcomes in Prostate Cancer: Observational, Population-Based Standing Cohort Study in England
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-17
Organisations:
Maximiliaan Nievaart - Chief Investigator - Janssen Pharmaceuticals UK
Craig Knott - Corresponding Applicant - Health Data Insight CIC
Alessandro Dos Santos - Collaborator - Janssen Pharmaceuticals UK
Amy Zalin-Miller - Collaborator - Health Data Insight CIC
Bhavini Patel - Collaborator - Janssen Pharmaceuticals UK
Simran Gill - Collaborator - Janssen Pharmaceuticals UK
Sophie Jose - Collaborator - Health Data Insight CICOutcomes:
A series of revised time-to-event outputs will be reported for this study, as summarised in Appendix 1 and bullet-pointed below.
* Overall survival (OS): defined from index to all-cause death or censoring.
* Progression-free survival (PFS): defined from index to the earliest of all-cause death, movement to a subsequent disease state, or censoring.
* Metastatic-free survival (MFS): defined from index to the earliest of all-cause death, movement to a metastatic disease state, or censoring.
* Event-free survival (EFS), ATLAS: defined from index to the earliest of all-cause death, PSA failure (2ng/ml increase in PSA over nadir), direct movement to a metastatic disease state, or censoring.
* Event-free survival (EFS), PROTEUS: defined from index to the earliest of all-cause death, biochemical failure (BCF), direct movement to a metastatic disease state, or censoring.
For the PROTEUS-like cohort, one of the failure events for the EFS outcome is BCF. BCF will be defined per the following criteria, with the date of BCF being equal to the final applicable PSA reading:
* Had two pairs of consecutive PSA readings dated within the disease state, with each pair of consecutive readings spanning an interval of at least one week.
* A rise in PSA between the consecutive readings of both pairs of PSA measures (one to two, and three to four).
* The final reading (reading four) yielded an absolute PSA of â¥0.2 ng/mL.Rules for the capture of movements between disease states are described later in the application, illustrated in Appendix 3, and with definitions tabulated in Appendix 2.
As a descriptive study, there are no a priori hypotheses.
As noted elsewhere in the submission, it is acknowledged that longitudinal measures of PSA will be fundamental for the capture of disease dynamics relevant to the some of the outcomes of interest. These include movements to subsequent disease states (such as are relevant for the estimation of PFS; see Appendix 2 for criteria for movements between disease states), or the capture of BCF within the EFS measure for the PROTEUS-like cohort. Based on NICE recommendations (i.e., NG131), it is hoped that PSA tests will have been repeated every three to six months within the population under study. However, it is expected that the frequency and completeness within the administrative datasets may fall short of this ideal. Per the planned feasibility exercise, outcomes dependent on these repeated measures of PSA will not proceed to analysis if PSA measures are deemed too sparsely or unreliably recorded for key dimensions of the disease pathway to be captured for the cohort under study.
Description: Lay Summary
Prostate cancer is the most common cancer among men in the UK. Although survival is high compared to other cancers common in men, prospects for older patients and those with more advanced disease are poor. The treatment of such patients has been challenging, with few effective options available and many patients becoming non-responsive to therapy such that their condition gets worse.
Janssen is interested in understanding the prostate cancer treatment pathway in England, analysing both primary and secondary care data to describe patient characteristics, the progression of their illness over time, the treatments they receive and their survival. Additionally, by combining these data with information from trials, researchers will be able to establish how well new treatments may perform if made available in England.
This research will provide valuable insights into prostate cancer care in England and the potential benefits to patients of new treatments for prostate cancer, particularly for prostate cancer patients at high risk of progression to more serious disease.
Technical SummaryThe study will provide insight into the clinical management and health outcomes of prostate cancer (PC) patients (ICD-10 C61) in England using cancer registrations from the National Cancer Registration Dataset (NCRD). Patients will be linked to data from the Clinical Practice Research Datalink (CPRD), Systemic Anti-Cancer Therapy dataset (SACT), Radiotherapy Dataset (RTDS), and Hospital Episode Statistics (HES) to map their progression through the course of disease.
Two trial-like cohorts will be created, consistent with the selection criteria for two PC trials:
* ATLAS (NCT02531516, EudraCT2015-003007-38)(1,2): a randomized, double-blind, placebo-controlled phase 3 study of apalutamide in subjects with high-risk, localised (LPC) or locally advanced prostate cancer (LAPC) treated with primary radiation therapy.
* PROTEUS (NCT03767244, EudraCT2018-001746-34)(3,4): a randomized, double-blind, placebo-controlled phase 3 study of apalutamide in subjects with high-risk, LPC or LAPC prostate cancer who are candidates for radical prostatectomy.The baseline characteristics of patients in these cohorts will be described at an aggregate level, plus their front-line therapy, longitudinal disease assessment, salvage therapy following biochemical recurrence (BCR), and time-to-event outcomes. In addition to these aggregate outputs, a subset of non-identifiable row-level data items analysed by HDI will be forwarded securely to Janssen-Cilag Limited to support three further analyses related to the development of health technology assessment (HTA) dossiers for the aforementioned trials: (i) the extrapolation of long-term survival outcomes observed within the two trial-like cohorts, (ii) an informed fits analysis to reduce uncertainty around separate extrapolations of time-to-event data for trial participants, and (iii) two indirect treatment comparisons. These will be described in more detail within later sections.
Together, these insights will establish a detailed picture of the treatment pathway and patient outcomes of two trial-like populations, aiding the optimisation of existing treatments and providing comparative effectiveness data for novel therapies undergoing trial.
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Risk of suicide attempt in patients prescribed leukotriene receptor antagonists (LTRAs) and inhaled corticosteroids (ICS): a self-controlled case series study — Wallis Lau ...
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Risk of suicide attempt in patients prescribed leukotriene receptor antagonists (LTRAs) and inhaled corticosteroids (ICS): a self-controlled case series study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-17
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Boqing Chen - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
The main effect estimates will be the incidence rate ratios (IRRs), which are estimated by comparing the rate of events (i.e., first suicide attempt) between the periods of:
1. LTRAs alone vs non-treatment
2. ICS alone vs non-treatment
3. Combination of LTRAs and ICS vs non-treatment
4. Combination of LTRAs and ICS vs ICS aloneDescription: Lay Summary
Asthma is one of the most common respiratory disorders in the UK. Leukotriene receptor antagonists (LTRAs) and inhaled corticosteroids (ICS) are two classes of medicines used to prevent the symptoms of asthma. Although they are widely used, there have been concerns about the mental health side effects of LTRAs and ICS.
Suicide attempt is one of the most serious side effects, however, the association between the use of each medication and suicide attempt remains unclear. This study, therefore, aims to explore whether the use of LTRAs or ICS is related to suicide attempt. This study will allow us to better understand the mental health side effects of LTRAs and ICS, and further help to inform the risk-benefit of the medicines and develop strategies to reduce the risk. If we find that the use of LTRAs or ICS increases the risk of suicide attempt, our study will further alert the healthcare professionals. If we find that the use of the medications is not related to the increased risk of suicide attempt, our study will provide reassurance regarding the safety of LTRAs and ICS to some extent.
Technical SummaryLeukotriene receptor antagonists (LTRAs) are prescribed primarily as an adjunct therapy to inhaled corticosteroids (ICS) in patients with asthma in the UK. Although there have been concerns about the psychiatric side effects of LTRAs and ICS, the association between the use of each medication and suicide attempt, one of the most severe outcomes, remains unclear. This study, therefore, aims to evaluate the association between LTRA and ICS use and suicide attempt, using data from CPRD. The Hospital Episode Statistics (HES) data will be used for identifying hospital records of suicide attempt. The Office of National Statistics (ONS) data will be used to identify any suicidal death.
We will conduct a self-controlled case series study including individuals aged 10 years and over, who had received at least one prescription of ICS, one prescription of LTRA, and with at least one outcome event (suicide attempt) between 1 January 2005 to 31 December 2022. Individuals will serve as their own control, and thus time-invariant confounders will be controlled. The observation period will be divided into the following categories: 90 days before the first use of each drug exposure (LTRA and ICS), use of LTRA alone, use of ICS alone, combination use of LTRA and ICS, and non-treatment period. The incidence of suicide attempt during LTRA alone, ICS alone, or combination use period will be compared with the non-treatment period. The incidence of suicide attempt during the combination period will be compared with the incidence during the ICS alone period to investigate whether the additional use of LTRA will increase the risk of suicide attempt. The adjusted incidence rate ratio (IRRs) will be calculated using conditional Poisson regression.
This study will allow us to better understand the psychiatric side effects of LTRAs and ICS, and further help to guide prescribing in patients.
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EXAcerbations of Chronic Obstructive Pulmonary Disease (COPD) and their OutcomeS (EXACOS)-CARBON: estimating the carbon footprint associated with the medical management of individuals living with COPD in England — Jennifer Quint ...
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EXAcerbations of Chronic Obstructive Pulmonary Disease (COPD) and their OutcomeS (EXACOS)-CARBON: estimating the carbon footprint associated with the medical management of individuals living with COPD in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-06
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Emily Graul - Corresponding Applicant - Imperial College London
Clementine Nordon - Collaborator - AstraZeneca Ltd - UK Headquarters
Constantinos Kallis - Collaborator - Imperial College London
Hannah Whittaker - Collaborator - Imperial College LondonOutcomes:
Annualised carbon footprint for HCRU for people with COPD in England
(i) HCRU over the first 24 months of follow-up (intermediate outcome);
(ii) GHG emission associated with this HCRU (final outcome).Description: Lay Summary
Chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema is a lung disease often caused by smoking. It is very common and is becoming more common. It causes a huge burden to patients with respect to day-to-day symptoms and is associated with an increased risk of death compared with the general population. Many people with chronic obstructive pulmonary disease have periods of acute deterioration, usually triggered by a chest infection, called an acute exacerbation. These exacerbations are associated with worsening symptoms, for example, increased shortness of breath, or increase in sputum and/or cough. Exacerbations are important to try and prevent and treat promptly because they worsen quality of life and are associated with hospitalisation and worsening in lung function and sometimes death. People who have lots of exacerbations of COPD have increased morbidity and healthcare resource utilisation (HCRU). We aim to quantify the environmental impact of COPD care, by undertaking a retrospective, cohort, healthCAReâBased envirONmental cost of treatment (CARBON) study estimating greenhouse gas (GHG) emissions in England associated with the management of patients living with COPD comparing people with different numbers of exacerbations. Targeting improved COPD exacerbations may elicit significant declines in carbon emissions, enabling healthcare systems to meet their carbon emission reduction goals.
Technical SummaryChronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema is a lung disease often caused by smoking. It is very common and is becoming more common. It causes a huge burden to patients with respect to day-to-day symptoms and is associated with an increased risk of death compared with the general population. Many people with chronic obstructive pulmonary disease have periods of acute deterioration, usually triggered by a chest infection, called an acute exacerbation. These exacerbations are associated with worsening symptoms, for example, increased shortness of breath, or increase in sputum and/or cough. Exacerbations are important to try and prevent and treat promptly because they worsen quality of life and are associated with hospitalisation and worsening in lung function and sometimes death. People who have lots of exacerbations of COPD have increased morbidity and healthcare resource utilisation (HCRU).
We aim to quantify the environmental impact of COPD care, by undertaking a retrospective, cohort, healthCAReâBased envirONmental cost of treatment (CARBON) study estimating greenhouse gas (GHG) emissions in England associated with the management of individuals living with COPD comparing people with different numbers of exacerbations. Targeting improved COPD exacerbations may elicit significant declines in carbon emissions, enabling healthcare systems to meet their carbon emission reduction goals.
People with COPD registered within the Clinical Practice Research Datalink (2014-2019) who contribute data to Aurum and are eligible for linkage with HES APC, OP, ONS mortality data and IMD data will be included. GHG emissions, measured as carbon dioxide equivalent (CO2e), will be estimated for (i) COPD-related medication use, and (ii) inpatient and outpatient care during a 24-month follow-up of patients with COPD classified at baseline by their severity (exacerbation frequency) as per the EXACOS-UK study (20_103R).
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Association between leukotriene receptor antagonist use and reduced risk of epileptic seizure: a self-controlled case series study — Wallis Lau ...
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Association between leukotriene receptor antagonist use and reduced risk of epileptic seizure: a self-controlled case series study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-02
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Boqing Chen - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
The main effect estimates will be the incidence rate ratios (IRRs), which will be estimated by comparing the incidence rates of events (i.e., the first epileptic seizures) between LTRA exposure periods and non-exposure periods.
Description: Lay Summary
Epilepsy is one of the most common brain conditions that causes frequent seizures, which are sudden bursts of electrical activity in the brain. Seizures can cause temporary abnormalities in behaviours, movements, sensations or states of awareness. The available medications relieve symptoms and reduce seizure attacks. However, there are significant challenges with the available medications, such as adverse reactions and a lack of agents that can prevent the development of epilepsy. Hence, alternative treatment methods that can help prevent and control the disease are needed.
Leukotriene receptor antagonists (LTRAs) are currently being used for the treatment of asthma and seasonal allergies. Animal studies have shown that LTRAs reduce seizure attacks and the severity of seizures. This study aims to assess the effect of LTRAs in reducing the risk of seizures at the population level. If we find that the LTRA use could reduce the incidence of seizures, our study will provide useful evidence of the potential of LTRAs to be developed into a class of drugs for epilepsy, which will further inform treatment guidelines and practices, and finally improve patientsâ health outcomes.
Technical SummaryEpilepsy is a chronic neurological disorder, characterized by the recurrence of unprovoked seizures. Anti-epileptic drugs are the commonly used treatment for epilepsy with the aim of controlling seizures. However, there are significant unmet medical needs and treatment challenges including drug-resistant epilepsy, adverse reactions, and lack of agents capable of averting the onset of epilepsy. Leukotriene receptor antagonists (LTRAs) are currently being used for asthma. Evidence from preclinical animal studies suggests that LTRAs reduce the incidence and severity of seizures.
This study aims to evaluate the association between LTRA use and epileptic seizures in the clinical setting, using data from CPRD. The Hospital Episode Statistics (HES) data will be used for capturing hospital diagnosis of seizures. The Office of National Statistics (ONS) data will be used to determine death. Linkage to Index of Multiple Deprivation will be used to describe the socioeconomic characteristics of the study cohort.
We will conduct a self-controlled case series study including individuals who had received at least one prescription of LTRA, and with at least one outcome event (epileptic seizure) between 1 January 2005 to 31 December 2022. Individuals will serve as their own control, and thus time-invariant confounders will be controlled. The observation period will be divided into the following categories: absence of LTRA period (baseline period), 90 days before LTRA treatment, the first 30 days of LTRA treatment, 31 to 180 days of LTRA treatment, and >180 days of LTRA treatment period. The association between LTRAs and epileptic seizures will be evaluated by comparing the incidence of seizures during exposure periods with that during non-exposure periods. The incidence rate ratio (IRRs) will be calculated using conditional Poisson regression.
The study will allow us to better understand the potential of LTRAs to be developed into anti-epileptic drugs, and further help to guide prescribing in patients.
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Prediction risk models for Cardiovascular disease for adults with asthma in England — Jennifer Quint ...
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Prediction risk models for Cardiovascular disease for adults with asthma in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-15
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College LondonOutcomes:
Outcomes to be measured: a composite measure (binary indicator) for having at least one cardiovascular event recorded within 12 months from their asthma index date. Cardiovascular events could have been recorded in either HES APC or Office for National Statistics (ONS) mortality data. Cardiovascular events defining our outcome variable were one the following types of cardiovascular complications: acute coronary syndrome (ACS), stroke, arrhythmia and heart failure (HF).
Description: Lay Summary
Asthma is very common in the UK, affecting 5.4 million people. People with milder disease can usually be managed successfully within primary care, by their GP or asthma nurse, and often have âwell controlled diseaseâ and experience relatively few adverse effects, such as asthma attacks (also known as exacerbations). However, some studies have suggested that some people with asthma may be at greater risk of having other conditions, in particular cardiovascular disease (e.g. a heart attack or a stroke) than people without asthma. Who is at risk though is not entirely clear, and it may be that certain things about having asthma increase a personâs risk. This study aims to use existing tools that look at certain factors and how they are associated with cardiovascular disease to create a personalised risk prediction model for cardiovascular disease in people with asthma. Information from this prediction model could then be used in clinical practice to help reduce peopleâs risk.
Technical SummaryIn the UK, over 5.4 million people have asthma, and asthma accounts for over 65,000 hospital admissions and 1,000 deaths annually. Previous studies have suggested that people with asthma may be at increased risk of developing cardiovascular disease compared with the general population. Understanding whether there are specific factors that affect the likelihood of having a cardiovascular event in people with asthma and how this may differ from one individual to the next has not been fully investigated. Our objective is to develop a personalised risk prediction model for cardiovascular events in people with asthma by exploring factors collected in routine data that may be associated with cardiovascular events. We will include a cohort of people with asthma aged 18 years and older and investigate factors associated with cardiovascular disease using CPRD Aurum data linked with hospital data, specifically HES APC, HES A&E, ONS mortality data and socioeconomic status (IMD) data. The study period will be 2010 to 2019. We will determine risk factors for prediction of cardiovascular events using logistic regression and consider other methods such as random forest. Information from this prediction model could then be used in clinical practice to help reduce peopleâs risk.
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Determining clusters of multiple long-term health conditions in patients undergoing surgery — Sivesh Kathir Kamarajah ...
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Determining clusters of multiple long-term health conditions in patients undergoing surgery
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-13
Organisations:
Sivesh Kathir Kamarajah - Chief Investigator - University of Birmingham
Sivesh Kathir Kamarajah - Corresponding Applicant - University of Birmingham
Francesca Crowe - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of BirminghamOutcomes:
> Primary: 30-day mortality
> Secondary: Readmission rates at 30-days, Development of further health conditions.Description: Lay Summary
The number of patients with more than one long-term health condition needing surgery are increasing in the NHS; for example, a patient with cancer who also has diabetes and heart disease. This is called having multiple long-term health conditions (MTLC) and it can make having surgery more complicated. Since it affects 1-in-3 patients undergoing surgery, who come from diverse backgrounds and communities, caring for them should be a focus for all healthcare professionals, including surgical teams. Using surgical encounters, both surgical disease and MLTC can be addressed efficiently.
However, at present, we do not know how common MLTC is in patients undergoing surgery, and what conditions group together. Further, we do not have information on the outcomes of these patientsâ undergoing surgery. To do this we will study a group of people who have surgery and MTLC. By linking data from primary care to hospital and mortality data we can see how these groups of conditions group together and whether people with different groups of conditions do better or worse after surgery. This research will help us make better plans to improve outcomes in people with MLTC undergoing surgery. This will benefit people with MTLC and may reduce the cost of surgical complications to the NHS.
Technical SummaryThe presence of multiple long-term conditions (MLTC) is a growing problem in the NHS. Early data suggests one of three patients undergoing surgery, who come from diverse backgrounds and communities, have MLTC. Therefore, caring for them should be a focus for all healthcare professionals, including surgical teams. Using surgical encounters, both surgical disease and MLTC can be addressed efficiently.
Over the past decade, research into MLTC has come from primary care defining epidemiology and clusters of disease across all patients in the NHS. However, the prevalence of MLTC and individual long-term health conditions in patients undergoing surgery compared to those not undergoing surgery are unclear. Further, there is no data characterising the impact of surgery in the trajectory of patients living with MLTC. Therefore, as surgeons, we do not have a good understanding of the exact scale of problem to better improve health and care for our patients.
This study aims to understand the prevalence and clusters of multimorbidity in patients undergoing surgery across the UK compared to those not undergoing surgery in the population. We will describe the epidemiology of pre-existing multimorbidity in patients undergoing surgery, multimorbidity clusters, investigate the association of multimorbidity with surgical outcomes and healthcare utilisation in primary and secondary care data.
The primary analysis is the prevalence and patterns of pre-existing MLTC in patients undergoing surgery compared to those not undergoing surgery. The secondary analysis include pre-existing MLTC in patients undergoing surgery stratified by the urgency (i.e., elective or emergency) and indication (i.e., benign or malignant) of surgery. The denominator was the total number of index surgeries. We will describe the MLTC pattern by counts, common combinations and by undertaking unsupervised cluster analysis (i.e., latent class cluster analysis) to determine characteristics and outcomes of patients in these clusters.
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External validation of a lifetime major bleeding risk model in cohort patients with established cardiovascular disease and lifetime effect of intensified antithrombotic treatment — Kausik Ray ...
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External validation of a lifetime major bleeding risk model in cohort patients with established cardiovascular disease and lifetime effect of intensified antithrombotic treatment
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-15
Organisations:
Kausik Ray - Chief Investigator - Imperial College London
Maria Castelijns - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Frank Visseren - Collaborator - Utrecht University
Laura Gunn - Collaborator - Imperial College London
Steven Hageman - Collaborator - Imperial College LondonOutcomes:
1. Major bleeding events defined as Bleeding Academic Research Consortium bleeding type 3 or 5, and/or bleeding events requiring hospital admission or resulting in death
2. Non-bleeding death.Description: Lay Summary
This research focuses on patients with heart-related diseases who are often prescribed blood-thinning drugs to help prevent future heart problems. Even with the best care and treatment, some people remain at high risk for more heart problems. In these cases, additional blood-thinning drugs may help reduce this risk. However, these drugs come with a catch: they can increase the chance of bleeding. So, it's important for patients and doctors to understand this risk before deciding to intensify treatment with more blood thinners, as they should give more benefit (reduce heart disease) than harm (bleeding).
This study aims to create a reliable tool that can help doctors in estimating the bleeding risk for each individual patient with heart disease and how much that risk might increase if their blood-thinning treatment is stepped up. The idea is to provide a tool that helps patients and doctors make better-informed decisions about their treatment.
Technical SummaryBackground: Guidelines recommend that prediction models for long-term cardiovascular event risk are used to help tailor preventive treatment to individual patients. For individuals with established atherosclerotic cardiovascular disease (ASCVD), intensification of antithrombotic treatment is one option to reduce ongoing risk. As bleeding is an important potential side effect of such treatment, the ability to accurately predict long-term bleeding risk, and in turn the potential harm of intensified treatment, would help facilitate informed and shared clinical decision making. A newly bleeding risk model is being developed, because existing bleeding risk models are either for prediction of bleeding events over the short-term, not competing-risk adjusted, and/or derived from trial populations and are therefore not optimised for use in this proposed context.
Aim: To externally validate the newly developed prediction model for lifetime bleeding risk in a population with established ASCVD, and predict the impact of intensified antithrombotic therapy on this risk.
Methods: The new bleeding risk prediction model will be applied to patients with established ASCVD from the Clinical Practice Research Datalink (CPRD) to estimate the long-term bleeding risk. CPRD covers long-term data of patients from primary care, where the majority of cardiovascular care is provided, and linkage to Hospital Episode Statistics and Office for National Statistics yields hospital admissions and mortality data for the outcome of major bleeding, concordant with
Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. Model performance will be assessed in terms of discrimination using C-statistics and calibration using plots depicting estimated and observed bleeding risks. Next, the hazard ratios from dual antiplatelet therapy and dual pathway inhibition trials and meta-analyses will be applied to estimate the predicted effect of antithrombotic treatment intensification.
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The association between psoriasis and dementia: a population-based matched cohort study — Charlotte Warren...
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The association between psoriasis and dementia: a population-based matched cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-15
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Catherine Smith - Collaborator - King's College London (KCL)
Julian Matthewman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Katrina Abuabara - Collaborator - University Of California, San Francisco
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sharon Cadogan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
dementia; dementia subtypes (Alzheimerâs disease, vascular dementia, mixed dementia, other)
Description: Lay Summary
Dementia is not a specific disease, it is a general term for a reduced ability to remember, think, or make decisions that interferes with everyday activities. Psoriasis is a skin condition where an overactive immune system causes inflammation and speeds up skin growth causing flaky skin patches that form scales. Existing research suggests dementia might be more common in people with psoriasis. But other research suggests people with psoriasis are not at any greater risk of dementia than others.
There is evidence that people with inflammation in the body during midlife are more likely to develop dementia. The inflammation of psoriasis could therefore explain a link between psoriasis and dementia. If so, it is possible that effective psoriasis treatment could delay or prevent dementia. Recently, new and effective targeted drugs have been introduced to manage psoriasis. However, currently these drugs are only recommended for severe psoriasis. If our study indicates psoriasis is linked to dementia, this could provide an argument for using these new drugs for people with milder psoriasis to reduce their dementia risk.
Our study will follow very large numbers of people with and without psoriasis over time to see whether they develop dementia. We will determine whether there is a link between psoriasis and dementia, after accounting for other differences between people with and without psoriasis. For example, it may be that people with psoriasis are more likely to experience other illnesses that might explain why they have more dementia rather than psoriasis itself.
Technical SummaryOur overall aim is to explore the relationship between psoriasis and dementia (all-cause and dementia subtypes), through a matched cohort study.
Existing evidence of an association between psoriasis and dementia is limited and conflicting. Evidence of a link between psoriasis and dementia would: 1) offer further insights into the well-demonstrated association between inflammation and dementia; and 2) influence clinical practice by highlighting the importance of monitoring cognitive function in those with psoriasis and offering interventions/lifestyle advice to limit dementia risk. Psoriasis is relatively common (up to 2% of population), our findings could have substantial public health impact.
We will establish a matched cohort of adults aged â¥40 years with psoriasis (both incident and prevalent cases), and an age, sex, and GP-practice matched cohort of individuals without psoriasis during the same period (from 1997 to latest linked data available). Follow-up of people without psoriasis will start on the same date as that of their matched person with psoriasis (i.e., for those with psoriasis follow up starts on the latest of: first record of a psoriasis diagnosis, GP registration plus one year, study start, 40th birthday, or date practice met CPRD quality control standards).
We will use Cox regression (adjusted for potential confounders and accounting for matching) to estimate hazard ratios comparing the risk of dementia in those with and without psoriasis. Potential confounders considered will include: lifestyle factors (e.g., smoking, harmful alcohol use, body mass index), socioeconomic deprivation, ethnicity, and comorbidities (e.g., cardiovascular disease, cerebrovascular disease). We will construct minimally adjusted models including just the main exposure variable (psoriasis) and implicitly adjusted for matching variables and underlying timescale, followed by sequential models adjusting for other potential explanatory variables (such as comorbidities and lifestyle factors). In separate secondary analyses we will explore whether psoriasis severity and psoriatic arthropathy increases risk of dementia.
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Use of topiramate and risk of glaucoma: a case-control study in UK primary care — Susan Jick ...
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Use of topiramate and risk of glaucoma: a case-control study in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-30
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
- Corresponding Applicant -
Christoph Meier - Collaborator - University of Basel
Luis Velez - Collaborator - University of Basel
Svenja Küng - Collaborator - University of BaselOutcomes:
Glaucoma (i.e., open angle, angle closure or unspecified)
Description: Lay Summary
The term âglaucomaâ describes a group of eye conditions with damage to the optic nerve. This is often caused by an abnormally high pressure in the eye. The biological basis of the disease is not yet fully understood. Glaucoma is one of the leading causes of blindness in the world.
Technical Summary
Topiramate is licensed to treat a medical condition affecting the brain (epilepsy) and for the prevention of severe headache attacks (migraine).
Recently, medical doctors reported about several patients who developed glaucoma after the use of topiramate. Furthermore, Canadian researchers performed a scientific study similar to this proposed study, and found a slightly increased risk of glaucoma in users of topiramate: topiramate users were 1,5 times more likely to have a glaucoma diagnosis than people in the general population. We therefore aim to assess the association between use of topiramate and the risk of glaucoma with data from UK primary care.
We will include patients with treated glaucoma and control patients with no glaucoma. We will compare previous use of topiramate in the two groups and calculate a relative risk which will tell us the odds of developing glaucoma in users of topiramate compared to non-users.
The results of this study will help patients, clinical practitioners and decision makers in the health care system to judge the risk of glaucoma associated with the use of topiramate.Previous case reports suggested an association between topiramate and glaucoma. In a case-control study using electronic medical records from British Columbia, researchers found a slightly increased risk of glaucoma after exposure to topiramate compared to unexposed controls. Our aim is to confirm or reject the results of the previous case-control study using a different data source (CPRD Aurum).
We will assess the use of topiramate in adult patients with a recorded incident diagnosis of and treatment for glaucoma (primary open angle glaucoma, primary angle closure glaucoma or unspecified glaucoma). Exposure will be defined as any use of topiramate in the years prior to the index date. We will also evaluate duration of use (i.e., number of prescriptions). We will compare topiramate use among patients with newly diagnosed glaucoma to a matched control sample of the general population without glaucoma or without increased intraocular pressure (>21 mmHg). The comparison group will be matched 1:4 on age, sex, index date (controls will have the same index date as the matched case), general practice, and years of history in the database before the glaucoma diagnosis (or the respective date in the controls). We will exclude patients with secondary or congenital glaucoma, HIV, drug/alcohol abuse, cancer except non-melanoma skin cancer, blindness, or less than three years of medical history on the database before the diagnosis date. We will apply conditional logistic regression to derive odds ratios and 95% confidence intervals. We will adjust our analysis for family history of glaucoma, a diagnosis of diabetes mellitus, use of systemic corticosteroids, and the number of GP visits one year prior to the glaucoma diagnosis.
The results of this study will aid patients, clinical practitioners and decision makers in the health care system to judge the risk of glaucoma associated with the use of topiramate.
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Using real-world data to replicate a trial on the efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2) — Samy Suissa ...
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Using real-world data to replicate a trial on the efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-01
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Gregory Brill - Collaborator - Brigham & Women's Hospital
Karine Suissa - Collaborator - Brigham & Women's Hospital
Laurent Azoulay - Collaborator - McGill University
Sebastian Schneeweiss - Collaborator - Brigham & Women's Hospital
Shirley Wang - Collaborator - Harvard UniversityOutcomes:
Change in hemoglobin A1c at 30 and 56 weeks
Change in weight at 30 and 56 weeksDescription: Lay Summary
Diabetes is a disease that occurs when a personâs sugar level in the blood is too high. People who have diabetes often need to take medications to lower the sugar in their blood. This study will use medical records from many patients to compare two medications for diabetes. This study will verify which of the two drugs is better at reducing the sugar levels and body weight. The results will be compared to the results of another study that looked at the same question but used fewer patients. This project is part of a bigger project that compares the results of many studies using medical records data with results from smaller studies. The goal is to better understand when and how questions on drug effects can be answered using only data from medical records. Findings from this study can be used to help patients and doctors better understand and apply results from these larger studies that use patients that are followed by general doctors in a typical clinic.
Technical SummaryThis project aims to emulate the SUSTAIN 2 trial as part of the RCT DUPLICATE initiative. The RCT DUPLICATE initiative was created to assess when and how certain drug effect questions can be answered using observational healthcare data. The SUSTAIN 2 trial was a phase III, multicentre, open-label, randomized trial that assessed the efficacy and safety of semaglutide, a new glucagon-like peptide-1 antidiabetic treatment administered subcutaneously as an add-on to metformin compared to sitagliptin among patients with type 2 diabetes. This trial will be emulated in the CPRD database using methods reported for the RCT for designing this real-world-data (RWD) study. We will evaluate change in HbA1c and weight outcomes at 30 and 56 weeks after cohort entry. Change in HbA1c will be calculated as the difference between the last baseline HbA1c measure and the closest follow-up measure at 30 weeks (+/-60 days) and 56 weeks (+/- 90 days). When an HbA1c measure does not occur in the predefined time window, they will be considered missing data. Change in weight will be calculated as the difference between the baseline weight (closest measure) and the follow-up weight measure at 30 and 56 weeks (closest measure). A missing weight measure will be considered no change in weight, but will require a visit during the period leading up to the 30- and 56-month timepoints (assuming the GP had the opportunity to measure the weight but chose to measure weight only if a change in weight was expected or observed). Patients will be censored at drug discontinuation, switching or augmenting to the other study drug, end of coverage, end of study period (03/31/2022), death, a maximum follow-up of 56 weeks, whichever occurs first.
Emulating SUSTAIN2 as part of RCT DUPLICATE will help patients and physicians better understand and apply results from RWD studies.
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A comparison of dynamic blood pressure treatment strategies and the risk of cardiovascular events among patients with hypertension: a retrospective cohort study — Samy Suissa ...
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A comparison of dynamic blood pressure treatment strategies and the risk of cardiovascular events among patients with hypertension: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-07
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Qi Zhang - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Tianze Jiao - Collaborator - University of FloridaOutcomes:
⢠Major adverse cardiovascular events, defined as a composite endpoint comprising nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death.
⢠Myocardial Infarction
⢠Stroke
⢠Cardiovascular death
⢠Coronary revascularization
⢠Hospitalization for congestive heart failure
⢠Hospitalization for angina
⢠Severe adverse events related to antihypertensive treatment (e.g., hypotension, syncope, electrolyte abnormalities, bradycardia, and acute kidney injury or failure resulting in emergency room visits or hospitalizations).Description: Lay Summary
Hypertension, commonly known as high blood pressure (BP), is a prevalent condition where the force of blood against the artery walls is elevated, potentially leading to heart diseases. This global issue affects around 1 billion adults worldwide. The severity of hypertension is determined by the level of BP, which also guides the treatment goal (known as target BP level). Over time, the target BP levels have changed. According to recent guidelines, which recommend a more aggressive approach to BP management, more patients will use BP lowering medications and will have lower treatment targets. However, certain aspects of these guidelines are based solely on expert opinion, and limited clinical evidence exists regarding this issue. There is therefore an urgent need to generate relevant evidence using real-world data to examine this issue.
We aim to examine different BP control plans using Clinical Practice Research Datalink by including patients who initiated any antihypertensive therapy between 1998 and 2018. Initially, we will investigate whether targeting a lower BP level for treatment-naive patients at low risk of heart problems results in delayed and reduced occurrences of heart diseases compared to higher BP levels. The ultimate goal is to devise a personalized BP control plan for patient with high blood pressure regardless of their cardiovascular risk level.
Technical SummaryBlood pressure level is used to classify the severity of hypertension and to determine treatment goals (i.e., target BP level), both of which changed over time. Treatment guidelines were recently revised to incorporate the results from two large randomized controlled trials (RCTs), ACCORD and SPRINT. However, those studies did not assess BP for patients at low cardiovascular disease (CVD) risk. To address this important knowledge gap, we will emulate a target trial using a retrospective, population-based cohort study to compare the risk of adverse cardiovascular events among patients following different dynamic blood pressure treatment strategies. This study will involve CPRD Gold data linked to Hospital Episode Statistics Admitted Patient Care, Office for National Statistics, and Index of Multiple Deprivation data. In the primary analysis, we will compare an intensive BP control plan (systolic blood pressure [SBP] â¤130 mm Hg and diastolic blood pressure [DBP] â¤80 mm Hg) and conservative BP control plan (SBP â¤140 mm Hg and DBP â¤90 mm Hg) to an extremely loose BP control plan (SBP â¤150 mm Hg and DBP â¤90 mm Hg) for patients with hypertension at low CVD risk. In secondary analyses, we will explore dynamic, personalized plans for all patients with hypertension regardless of estimated CVD risk. The primary outcome will be the occurrence of major adverse cardiovascular events, a composite endpoint that include cardiovascular death, myocardial infarction, and ischemic stroke. Dynamic marginal structural modelling and inverse-intensity-rate-ratio weight will be applied to minimize time-dependent confounding and differences in covariate-dependent follow-ups, respectively.
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Epidemiology, outcomes, healthcare resource utilisation, and inequities among amyloidosis patients in the UK, an observational study — He Gao ...
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Epidemiology, outcomes, healthcare resource utilisation, and inequities among amyloidosis patients in the UK, an observational study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-01
Organisations:
He Gao - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Emily Peach - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Corinna (Lai San) Hong - Collaborator - AstraZeneca Ltd - UK Headquarters
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Eric Wittbrodt - Collaborator - AstraZeneca Ltd - UK Headquarters
Ewan Laws - Collaborator - AstraZeneca Ltd - UK Headquarters
Jil Billy Mamza - Collaborator - AstraZeneca Ltd - UK Headquarters
Krister Järbrink - Collaborator - Astra Zeneca R&D Molndal Sweden
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Mara Habash - Collaborator - AstraZeneca Ltd - UK Headquarters
Meg Parbrook - Collaborator - AstraZeneca Ltd - UK Headquarters
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK Headquarters
Shikta Das - Collaborator - AstraZeneca Ltd - UK Headquarters
Stefan Franzén - Collaborator - AstraZeneca AB (Sweden)Outcomes:
The following will be measured at amyloidosis diagnosis (index date) and prior to diagnosis:
Patient characteristics; demographics, family history, comorbidities, key comorbidities and clinical characteristics of relevance to amyloidosis.
Healthcare resource utilisation (HCRU); number of hospital admissions, number of bed days, medications and total cost of care stratified by inpatient, outpatient, and pharmacy costs when available.These will be measured after amyloidosis diagnosis (post index date):
Management, including pharmacologic treatment and patterns, as well as medical procedures.
Changes in clinical characteristics, functional status, HCRU, and health related quality of life (HRQoL) (when available).
Death and cause of death (when available).Description: Lay Summary
Amyloidosis is a rare disease, multisystemic condition in which a protein is deposited in various organs and tissues, leading to their dysfunction and potentially fatal consequences.
Symptoms are not specific to amyloidosis and other conditions can cause similar clinical manifestations, thus the disease can be easily misdiagnosed or overlooked. Currently, real-life data on the patient journey, including clinical outcomes, disease progression, treatment patterns, healthcare resource utilisation and management of patients with amyloidosis is limited.
The overall aim of this study is to assess the distribution of the disease, pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes in patients with amyloidosis in the United Kingdom (UK). Utilizing UK Clinical Practice Research Database (CPRD) data for the historic anonymized patientâs records will allow us to have a better understanding of the early presentation and progression of the disease across the UK. This study will help to establish improved recommendations for diagnostic and therapeutic procedures in the follow-up of both pre-symptomatic patients and those with diagnosed and undiagnosed amyloidosis.
Technical SummaryAmyloidosis is a set of disorders due to misfolding, aggregation and accumulation of certain proteins, known as amyloid deposits, in various tissues or organs leading to cellular damage, organ dysfunction, and eventually death. Based on the protein that forms the amyloid fibrils, amyloidosis can be classified as systemic light-chain (AL) amyloidosis, systemic amyloid A (AA) amyloidosis, and transthyretin amyloidosis (ATTR). A recent study using data from the UK National Amyloidosis Centre database, reported that the number of cases of amyloidosis increased by 670% from 1987-1999 to 2010-2019. (1)
Amyloidosis is often overlooked or misdiagnosed in patients, at least early in its course, due to the non-specific, heterogenous, multisystem presentation. As the disease progresses, the symptoms often mimic those of other more common diseases, further complicating and delaying diagnosis.
The overall aim of this study is to provide a UK perspective on the epidemiology, pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes in patients with amyloidosis, and to better understand how the disease is presented to support early recognition, diagnosis, and treatment for the benefit of patients in the UK.
Methods and analysis plan:
This study will include data from patients aged â¥18 years with a diagnosis code for amyloidosis.
We will include patients with diagnosed amyloidosis from the CPRD Aurum or GOLD data or from their linked HES records. Patients will be followed until exit from the database (loss to follow-up), death, or end of database period (data collection). Index date is defined as the first date of amyloidosis diagnosis anytime in a patientâs medical records. All available medical history before the index date will be used to assess patient demographics, clinical characteristics and healthcare resource utilisation before diagnosis.
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Exploring inequalities in diagnoses and outcomes of gynaecological cancers in England — Jennifer Davidson ...
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Exploring inequalities in diagnoses and outcomes of gynaecological cancers in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-20
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
James Baird - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Mico Hamlyn - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
- Incidence of each cervical, ovarian, uterine, vaginal, and vulval cancer
- Cancer stage at first diagnosis for each cervical, ovarian, uterine, vaginal, and vulval cancer
- Patient pathway for diagnosis of each cervical, ovarian, uterine, vaginal, and vulval cancer
- Time from symptom to diagnosis for each cervical, ovarian, uterine, vaginal, and vulval cancer
- Time from diagnosis to treatment for each cervical, ovarian, uterine, vaginal, and vulval cancer
- 1-, 2- and 5-year survival rate for each cervical, ovarian, uterine, vaginal, and vulval cancerDescription: Lay Summary
Cancers of the female reproductive system (i.e., cervical, ovarian, uterine, vaginal and vulval or summarised as gynaecological cancers) can affect many women despite some of them being not very common. Previous research suggests that there are differences in who attends screening, how quickly their cancer is diagnosed, and how the cancer is treated, amongst different ethnic groups and for people who live in more deprived areas.
Technical Summary
We will explore differences in diagnosing and treating gynaecological cancers by age, ethnicity, and deprivation. We will use linked primary care and hospital data to look at differences in how often each cancer type gets diagnosed, how severe the cancer is when it is diagnosed, how long patients wait for their diagnosis after showing symptoms, how long they wait for their treatment after first diagnosis, and death.
Understanding differences in diagnosis and treatment of gynaecological cancer can help to improve access to healthcare for people who might have experienced difficulties getting care or who are at high risk of more severe outcomes.Gynaecological cancer is a collective term for cervical, ovarian, uterine, vaginal and vulval cancers with an incidence of more than 18,000 cases in England every year. Previous studies have suggested that there might be differences in screening attendance, number of diagnoses, cancer stage at diagnosis, access to treatment, and outcomes for different ethnic groups or by socioeconomic status. However, these studies have mainly been focused on endometrial, cervical, or ovarian cancer individually, and very few studies are in a UK healthcare setting.
For this study, we will use the Clinical Practice Research Datalink (CPRD) Aurum and linked Hospital Episodes Statistics, Office for National Statistics deaths registrations, and Index of Multiple Deprivation data to explore health inequalities in all types of gynaecological cancers by age, ethnicity, and socioeconomic status. We will describe differences in incidence, cancer stage at diagnosis, time-to-diagnosis, time-to-treatment, and survival. Furthermore, we will perform Poisson regression and survival analyses using Cox proportional hazards regression to test for these differences between ethnicities, age groups and levels of deprivation.
Understanding inequalities in diagnosing and treating gynaecological cancer can help to inform health policy to improve access to healthcare across different groups of the population, e.g., by improving access to screening and encouraging uptake, which then could improve times to treatment and survival of different patients in the long term.
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD) — Clare Bankhead ...
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-23
Organisations:
Clare Bankhead - Chief Investigator - University of Oxford
Cynthia Wright Drakesmith - Corresponding Applicant - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Robert Williams - Collaborator - University of OxfordOutcomes:
Incidence of stroke among patients with epilepsy
Description: Lay Summary
Over the last few years, organisations who make data available for public health research have been looking for ways to improve data sharing and security among users of the data. One approach that has been recommended in the UK is the use of platforms which allow access to data so analysis can be performed but limited outputs (e.g. aggregated results) can be exported. CPRD are working to establish such a platform for its users. However, it is key that the platform still enables vital health research to be performed. To help assess this, a study looking at epilepsy and stroke will be conducted.
Epilepsy is the name for a group of chronic conditions which result in repeated seizures and affects people of all ages, genders and ethnicities. Epilepsy has been linked to other conditions, including stroke. However, studies in this area have been limited and not recent.
The aims of this study are to provide more updated information on the statistics of stroke in epileptic patients while also assessing if important research can be conducted in CPRDâS secure platform. As there is a drive for more organisations to use such platforms, this research will benefit public health by ensuring such methods do not hamper research using CPRD data.
Technical SummaryThe main aim of this study is to calculate the incidence of stroke among patients with epilepsy who were prescribed anti-seizure medication. This research will benefit public health by presenting an updated picture of the disease in the UK thus highlighting areas of improvement in the management of such patients and suggesting areas for further research. Additionally, this study aims to test the use of CPRDâs secure platform to ensure it will enable data access and analysis for important health research.
This is a retrospective cohort study of epileptic patients prescribed anti-seizure medication with an incident record of stroke between 01/012010-31/12/2019 in their primary or secondary care data record.
The CPRD primary care data will be used for defining the study population. This will also be linked to the Hospital Episode Statistics Admitted Patient Care (HES APC) data (for defining the outcome of stroke), Office for National Statistics (ONS) Death Registration data (for defining the outcome of stroke and the date of death), and patient-level Index of Multiple Deprivation (IMD) data (as a covariate).
Descriptive results will be presented for patient demographics and incidence rates will also be calculated as the number of newly diagnosed stroke events in patients with epilepsy (numerator) divided by the sum of the person years of follow-up of epileptic patients during each calendar year of interest. The rates will be stratified by age group, gender, and year of stroke diagnosis.
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Defining fibrotic hypertension in electronic healthcare records — Jennifer Quint ...
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Defining fibrotic hypertension in electronic healthcare records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-13
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Georgie Massen - Corresponding Applicant - Imperial College London
Gisli Jenkins - Collaborator - Imperial College London
Iain Stewart - Collaborator - Imperial College London
Louise Wain - Collaborator - University of Leicester
Upasana Tayal - Collaborator - Imperial College LondonOutcomes:
Proportion of people with fibrotic hypertension who also have fibrosis in multiple organs
Analysis of the median time to multiple organ fibrosis from single organ fibrosis.
Description of the order in which fibrotic diseases occur.Description: Lay Summary
Some diseases cause organ scarring, damaging the affected organ, and decreasing its ability to function,
Technical Summary
eventually leading to organ failure. These diseases can be referred to as being fibrotic. Hypertension is a common condition which is defined by high blood pressure and is believed in some cases to be a fibrotic disease. However, hypertension is a broad condition with varying degrees of severity and some forms are unlikely to be fibrotic. People who have more severe hypertension, (e.g., needing lots of treatments, or having had it for a long time) are more likely to have fibrotic hypertension.
We will use routinely collected healthcare records to define âfibrotic hypertensionâ, using a range of definitions including self-controlled hypertension (such as through diet and lifestyle changes), hypertension controlled by medication and resistant hypertension (i.e. needing lots of medication or hospital admission to control it) to determine which definition is best to use to find fibrotic hypertension. Once we have done this, using these different definitions of fibrotic hypertension, we will explore how common fibrotic hypertension is relative to other fibrotic diseases, following on from work we have done around defining those other fibrotic conditions already. This will help us to better understand how commonly these conditions occur together and in what order they happen. This may help us to know where to target treatments in the future.Fibrosis can affect any organ; fibrotic conditions are characterised by excessive, uncontrolled deposition of extracellular matrix in the effected site, this in turn alters the tissueâs extracellular environment, leading to organ failure. Despite fibrosis leading to eventual organ death, there is still a large gap in the understanding of fibrotic diseasesâ aetiologies and pathways. Fibrotic multi-morbidity is defined as the simultaneous occurrence of more than one fibrotic condition in a patient. Previous work using a Delphi methodology determined conditions which were always/ sometimes fibrotic using clinical consensus. As a result of this work hypertension was defined as being sometimes fibrotic. We will apply six definitions of hypertension (based on clinical guidelines as well as hospitalisation due to poor hypertension control) and describe the differences in the number of fibrotic conditions each phenotype is diagnosed with. This will guide how we best define fibrotic hypertension in clinical records (e.g., if one of the populations suffer from more fibrotic conditions we could infer that the hypertensive phenotype is more likely to exhibit fibrosis. We will use CPRD Aurum data linked with HES, ONS and IMD to conduct this analyses. We will describe the proportion of people in each subgroup that have other fibrotic conditions (applying a pearsons chi squared test), describe the median time between diagnosis of hypertension and diagnosis of another fibrotic conditions and describe the order that diagnoses are commonly made.
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Burden, risk and trends of non-communicable diseases, mortality and hospitalisation among people living with HIV compared to people without HIV — Tiffany Gooden ...
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Burden, risk and trends of non-communicable diseases, mortality and hospitalisation among people living with HIV compared to people without HIV
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-11-30
Organisations:
Tiffany Gooden - Chief Investigator - University of Birmingham
Tiffany Gooden - Corresponding Applicant - University of Birmingham
G. Neil Thomas - Collaborator - University of BirminghamOutcomes:
- Overall prevalence and incidence of hypertension, diabetes, anaemia, depression, anxiety, self-harm, attempted suicide, schizophrenia, bipolar disorder, all-cause and cause-specific hospitalisation and mortality among PLWH and separately for people without HIV.
- Annual trends of prevalence and incidence of hypertension, diabetes, anaemia, depression, anxiety, self-harm, attempted suicide, schizophrenia, bipolar disorder, all-cause and cause-specific hospitalisation and mortality among PLWH and separately for people without HIV.
- Risk of hypertension, diabetes, anaemia, depression, anxiety, self-harm, attempted suicide, schizophrenia, bipolar disorder, all-cause and cause-specific hospitalisation and mortality in PLWH compared to people without HIV.Description: Lay Summary
New diagnoses of HIV have decreased, though, as care and management improve, the overall number of people living with HIV (PLWH) has increased. Due to complex reasons, PLWH may have a higher burden and/or a higher risk of developing other chronic conditions compared to people without HIV. These reasons include the exposure to toxic drugs, consistent inflammation, and immune activation despite being on effective medication, traditional risk factors such as smoking and physical inactivity, HIV-related stigma and other psychosocial factors. However, these factors change over time and may have impacted the burden and risk of PLWH developing other conditions in the last 20 years. Living with multiple chronic conditions can negatively impact quality of life, patient safety, and clinical outcomes. It is therefore important to understand the current burden of common conditions that PLWH develop and how their risk compares to people without HIV to ensure services are optimally designed for providing specialised care to PLWH and reduce premature mortality.
We will investigate the burden, risk and trends of various conditions including high blood pressure, depression, anxiety, severe mental illness, all-cause hospitalisation and mortality, and cause-specific hospitalisation and mortality among PLWH from 2001 to 2022. These findings will provide healthcare providers and policy makers with evidence on which conditions PLWH are at higher risk for, which occur most frequently, and which are related to healthcare utilisation (hospitalisation) and death. Thus, these results will be imperative for adapting health services to prevent and improve care for common co-existing conditions among PLWH.
Technical SummaryPeople living with HIV (PLWH) experience persistent inflammation and immune response and toxicity from antiretroviral therapy (ART); these mechanisms combined with increased prevalence of behavioural and psychosocial risk factors may contribute to a higher burden of non-communicable diseases (NCDs) among PLWH. In turn, PLWH may have worse clinical outcomes and more healthcare utilisation compared to people without HIV. The aim of this study is to compare prevalence, incidence, risk and trends of various NCDs and all-cause and cause-specific hospitalisation and mortality in PLWH with people without HIV.
From 1st January 2001 to 31st December 2022, we will calculate the prevalence, incidence, risk and trends of hypertension, diabetes, anaemia, depression, anxiety, self-harm, attempted suicide, schizophrenia, bipolar disorder among PLWH aged 15 or older and compare these findings to people without HIV using data from CPRD Aurum. We will also look at prevalence, incidence, risk and trends of cause-specific hospitalisation and mortality among PLWH compared to matched people without HIV, using linked data from Hospital Episode Statistics and Office for National Statistics, respectively; these outcomes will be categorised using ICD-10 chapters with an additional category created for AIDS-related causes.
Overall prevalence and incidence will be calculated over the 22-year study period and annually for trends. A Cox proportional hazards regression will be used to calculate risk of each outcome between PLWH and people without HIV matched by age, sex, ethnicity, and geographical location.
The results to this research have the potential to provide high quality evidence that could have implications on healthcare delivery, clinical practice and prevention strategies for PLWH, particularly given the changes made to ART over the last 20 years. The findings can and should inform ways to prevent NCD comorbidities, hospitalisation and premature mortality among PLWH; thus, improving PLWH quality of life, and reducing healthcare costs.
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ID-375: The Real-World Use and Cost of Health and Social Care Associated with Vaccine Preventable Respiratory Disease — Lane Clark & Peacock LLP...
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ID-375: The Real-World Use and Cost of Health and Social Care Associated with Vaccine Preventable Respiratory Disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Vaccine preventable respiratory disease. Commercial
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ID-374: PREPARE: Evaluation of the Electronic Palliative Care Coordination Systems to support advance care planning for people living with life-limiting conditions — Royal Marsden NHS Foundation Trust...
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ID-374: PREPARE: Evaluation of the Electronic Palliative Care Coordination Systems to support advance care planning for people living with life-limiting conditions
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-23
Opt Outs: no information provided./p>
Organisations: Royal Marsden NHS Foundation Trust
Description: Palliative care coordination systems.
Source
2023 - 10
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ADR UK PhD studentships cohort — unknown...
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ADR UK PhD studentships cohort
Where: unstated
When: 2023-10-24
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is supporting 22 PhD studentships hosted by supervisors at Economic and Social Research Council (ESRC) Doctoral Training Partnerships (DTPs) across the UK. These PhD studentships will use ADR UKâs new flagship datasets to answer policy-relevant research questions.
ADR UK-supported PhD studentships cover ADR UK research themes. The ADR UK PhD studentship cohort will promote the wider use of administrative data for research, leading to better informed policy decisions and more effective public services. In addition, these studentships will also support ESRC DTPs in developing their capacity in priority areas highlighted by the ESRCâs review of the PhD in the social sciences, including data skills and advanced quantitative methods training.
Scroll down for more information on each student, their associated project and theme(s), and related datasets. The list is organised alphabetically by the studentsâ last names.
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Inequalities among marginalised groups, diagnosed with breast cancer, in relation to routes to diagnosis, diagnostic intervals, and pre-treatment intervals, before and after the COVID-19 pandemic: a cross-sectional analysis of national data — Robert Kerrison ...
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Inequalities among marginalised groups, diagnosed with breast cancer, in relation to routes to diagnosis, diagnostic intervals, and pre-treatment intervals, before and after the COVID-19 pandemic: a cross-sectional analysis of national data
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-09
Organisations:
Robert Kerrison - Chief Investigator - University of Surrey
Robert Kerrison - Corresponding Applicant - University of Surrey
Agnieszka Lemanska - Collaborator - University of Surrey
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Kate Sykes - Collaborator - Northumbria University
Tanimola Martins - Collaborator - University of Exeter
Tetyana Perchyk - Collaborator - University of SurreyOutcomes:
Route to diagnosis; Diagnostic intervals; Pre-treatment intervals
Description: Lay Summary
Women from marginalised groups, such as women from ethnic minority groups, are often at an increased risk of dying from breast cancer. One of the main reasons for this, is that women from marginalised groups tend to be diagnosed at a more advanced stage, when the disease is more difficult treat.
There are several reasons why women from marginalised groups tend to be diagnosed at a later stage. The first is the way in which they are typically diagnosed (they are less likely, for example, to be diagnosed through screening, which has the best chances for early detection). The second, is that it typically takes longer for them to receive a diagnosis. The third is that they typically wait longer to start treatment.
At present, much of our understanding of inequalities in breast cancer pre-dates the COVID-19 pandemic, and there is growing concern that inequalities may have widened over the past three years, due to the measures implemented to mitigate COVID. For example, breast screening services were suspended from 31st March, until 1st September 2020, and since restarting, the overall uptake of breast screening has declined, particularly in areas which are ethnically diverse or socioeconomically deprived.
To understand the extent to which the COVID-19 pandemic has widened inequalities in breast cancer, robust analyses of national data are now needed. Such analyses would allow us to confirm where inequalities have widened and would allow us to target future interventions to those who need them most, where they most need them.
Technical SummaryRoute to diagnosis, the diagnostic interval and the pre-treatment interval are all important determinants of breast cancer survival. Evidence suggests that all three may be subject to inequalities, with individuals from marginalised groups (such as those experiencing deprivation) being more likely to experience longer diagnostic and pre-treatment intervals than those from 'non-marginalised' groups, as well as being more likely to be diagnosed via less favourable routes (e.g. emergency presentation). The evidence for these inequalities, however, predates the COVID-19 pandemic, and there is growing concern they have since widened.
The primary aim of this research is to assess whether differences in the proportion of individuals diagnosed through less favourable routes to diagnosis, and differences in the mean number of days patients wait to receive a diagnosis and start treatment, have disproportionately widened for individuals from marginalised groups, compared with individuals from non-marginalised groups, since the beginning of the COVID-19 pandemic.
Whether differences in the proportion of individuals diagnosed through less favourable routes to diagnosis, and differences in the mean number of days patients wait to receive a diagnosis and start treatment, have widened disproportionately for individuals from marginalised groups, compared with individuals from non-marginalised groups, since the beginning of the COVID-19 pandemic, will be assessed by:
1) comparing differences in the proportion of 'marginalised' and 'non-marginalised' individuals diagnosed through less favourable routes to diagnosis, before 31st March 2020, with differences after 31st March 2020;
2) comparing differences in the number of days to diagnosis, between 'marginalised' and 'non-marginalised' individuals, before 31st March 2020, with differences after 31st March 2020;
3) comparing differences in the number of days to treatment, between 'marginalised' and 'non-marginalised' individuals, before 31st March 2020, with differences after 31st March 2020.
Differences will be assessed using multinomial regression (routes to diagnosis) and accelerated failure time models (diagnostic/pre-treatment intervals).
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Sociodemographic factors, multimorbidity and frailty determinants in the delay of heart failure diagnosis, treatment and subsequent prognosis; UK trends over 20 years and impact of the Covid-19 pandemic — Claire Lawson ...
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Sociodemographic factors, multimorbidity and frailty determinants in the delay of heart failure diagnosis, treatment and subsequent prognosis; UK trends over 20 years and impact of the Covid-19 pandemic
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-10
Organisations:
Claire Lawson - Chief Investigator - University of Leicester
Claire Lawson - Corresponding Applicant - University of Leicester
Amitava Banerjee - Collaborator - University College London ( UCL )
Christopher Miller - Collaborator - University of Manchester
IAIN SQUIRE - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Rhys Williams - Collaborator - Cwm Taf University Hospital Board
shirley Sze - Collaborator - University of LeicesterOutcomes:
Primary outcome: Time to diagnosis.
Secondary outcomes:
- Recording of a NT-proBP test, echocardiogram, referral to a cardiovascular specialist.
- Prescription of a first line GDMT (Angiotensin Converting Enzyme inhibitors (ACEi), angiotensin receptor-neprilysin inhibitor (ARNI), Angiotensin II receptor blockers (ARBs), mineralocorticoid receptor antagonist (MRA), HF specific beta blocker, Sodium-glucose Cotransporter-2 (SGLT2). Other HF drugs (Hydralazine/nitrate, diuretic, digoxin, statin) will also be identified.
- The number of health care annual contacts in the 5 years prior to diagnosis and from diagnosis
- Time to first all-cause and HF hospitalisation.
- Time to all-cause mortality.
- Change in frailty status from diagnosis.Description: Lay Summary
Heart failure (HF) affects over one million people in the UK and has a high death rate, with one in three patients dying within a year of diagnosis. Delays in diagnosing and treating HF are common, with most patients only diagnosed once admitted to hospital, leading to worse outcomes. Diagnosis delays are more frequent in patients with multiple conditions, frail individuals, women, and those from deprived backgrounds. The impact of the Covid-19 pandemic on these delays and patient outcomes remains unknown.
Aim: To investigate the relationship between patient characteristics (age, sex, ethnicity) and clinical factors and the diagnostic care received by adults with new HF before and after the Covid-19 pandemic. The study will examine tests, specialist referrals, time delays, and treatments, and their influence on patient outcomes.
Objectives:
(i) To assess the association between patient characteristics and clinical factors and the diagnostic care received.
(ii) To determine trends in diagnostic care before, during, and after the Covid-19 pandemic.
(iii) To examine the time elapsed between patients' first HF symptom and their diagnosis, considering different patient and clinical groups over time.
(iv) To investigate the relationship between diagnostic delays and outcomes such as hospitalisation, future frailty status, and death.
(v) To explore changes in frailty over time for individuals with HF and its impact on outcomes.The study's findings will help highlight the patient groups at the highest risk of delayed HF diagnosis. This valuable information will be shared with patients and healthcare professionals to enhance HF diagnosis and care.
Technical SummaryBackground: The projected increase in HF hospitalizations by 50% over the next decade highlights the need for early diagnosis and treatment. However, UK data reveals that only 25% of newly diagnosed HF patients follow the recommended diagnostic pathway, resulting in an average delay of two years from symptom onset. Over half of the patients receive a diagnosis only after being admitted to the hospital. Challenges in diagnosis are particularly evident among different socio-demographic groups and in patients with multiple conditions. Therefore, it is crucial to gather current evidence on the evolving diagnostic pathways for different groups and assess their impact on outcomes.
Design: Retrospective cohort design.
Methods: Patients, aged â¥18 years, with new HF will be identified in CPRD and hospital records. First presentation of HF symptoms will be identified in the 5-years preceding HF diagnosis. Time to diagnostic tests, specialist referral, prescription of guideline HF drugs, and diagnosis will be calculated for different sociodemographic, multimorbid, and frailty groups among those presenting with their first symptom. The analyses will investigate (i) the relationship between sociodemographic and clinical factors and the care received, (ii) how sociodemographic and clinical factors relate to delay in the diagnosis of HF, (iii) how delay in diagnosis relates to outcomes (healthcare hospitalisation, future frailty status and mortality); (iv) Temporal trends in clinical care factors and delay will be assessed within various groups, considering age, sex, ethnicity, socioeconomic status, multi-morbidity, frailty, and the pre, peri, and post-Covid-19 pandemic periods and (v) to explore distinct patterns of frailty trajectories in HF patients, along with their prognostic implications.
Outcomes: This project aims to identify the changing epidemiology of patients at the highest risk and provide potential solutions for improving the diagnostic and treatment pathways for individuals with heart failure, considering patient, clinical, and health service factors.
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Characterising and assessing long term outcomes in patients with prostate cancer — Eng Hooi Tan ...
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Characterising and assessing long term outcomes in patients with prostate cancer
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-05
Organisations:
Eng Hooi Tan - Chief Investigator - University of Oxford
Nicola Barclay - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Danielle Newby - Collaborator - University of Oxford
Sara Khalid - Collaborator - University of OxfordOutcomes:
For Objective 1: Clinical progression; metastasis; mortality; morphology; biochemical recurrence
For Objective 2: Incidence of PCa
For Objective 3: Description of treatment patterns, no outcomes measured
For Objective 4: Adverse events (such as rectal/bladder/bowel/ureteric injury, urethral stricture/incontinence, hospitalisation etc) from surgical/radiological treatment of PCaDescription: Lay Summary
Prostate cancer (PCa) is the most common cancer in men across Europe. Current clinical guidelines group patients according to their risk during diagnosis and are used to predict their disease progression. There are many different treatment options and treatment patterns are complex. There is no consensus over the optimal categorisation and treatment strategy.
This study has the following aims:
1) to predict outcomes of PCa patients categorised by individual disease characteristics, demographics, socioeconomic factors and comorbidities
2) to assess the use of genetic screening in diagnosing patients with risk of PCa
3) to describe demographics and clinical characteristics of PCa patients according to treatment modes and describe their treatment patterns
4) to describe and compare treatment side effects of surgery versus radiotherapyOur findings could better inform clinical practice guidelines on the management of PCa patients from diagnosis to treatment options and management of treatment side effects.
Technical SummaryThis study aims to describe demographics, clinical characteristics and treatment/cancer care patterns, estimate treatment effects, and predict according outcomes of prostate cancer (PCa) patients across a network of databases in the male population of Europe and the US, and subgroups of patients identified by individual disease characteristics, demographics, socioeconomic factors and comorbidities. In detail, the main objectives are:
1. To optimise the European Association of Urology (EAU) Guideline risk stratification to better predict progression in men with localised and locally advanced non-metastatic PCa
2. (to be removed)
3. To characterise detailed treatment patterns and outcomes of patients with advanced PCa
4. To estimate the long-term side effects of surgical versus radiological treatment of PCaThe intended public health benefit of this is to provide clinicians with real-world evidence of the factors affecting prognosis in PCa, allowing them to optimise and personalise treatment strategies.
The cohorts of interest include adult male patients with PCa diagnosis and PCa treatment. We will conduct a network cohort study using data mapped to the Observational and Medical Outcomes Partnerships (OMOP) Common Data Model (CDM).
For Objective 1, we will predict the progression of PCa patients using Cox regression and machine learning models. (Note that Objective 2 will be omitted in a post-approval amendment). For Objective 3, the treatment patterns of advanced PCa will be described. For Objective 4, the adverse events from surgical versus radiological treatment of PCa will be described and compared using propensity score matched Cox Regression.
For all objectives, all populations and outcomes of interest will be identified using CPRD data and linkage to Hospital Episode Statistics (HES) for hospital procedures, National Cancer Registration and Analysis Service (NCRAS) for cancer staging and Radiotherapy Data Set (RTDS) and Systemic Anti-Cancer Therapy data set (SACT) for treatment and treatment outcomes.
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DARWIN EU - EHDS Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 in the context of the OMICRON variant, a population-based cohort study — Martà Català Sabaté ...
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DARWIN EU - EHDS Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 in the context of the OMICRON variant, a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-09
Organisations:
Martà Català Sabaté - Chief Investigator - University of Oxford
Xintong Li - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
1. Venous thromboembolic events
In the primary analysis, venous thromboembolic events include pulmonary embolism or deep vein thrombosis.
2. Arterial thromboembolic events
In the primary analysis, arterial thromboembolic events include acute myocardial infarction or acute ischemic stroke.
3. Cardiovascular events
Instances of heart failure, cardiac arrhythmia, and angina will be identified. In addition, major cardiovascular events (MACE) will be identified by heart failure, acute myocardial infarction, or stroke, or the occurrence of sudden cardiac death.
In the secondary analysis, pulmonary embolism, deep vein thrombosis, acute myocardial infarction and acute ischemic stroke will be studied separately.Description: Lay Summary
Venous thromboembolism (VTE) is a condition that occurs when a blood clot forms in a vein and obstructs the blood flow. Arterial thromboembolism (ATE) is a blood clot that develops in an artery. Evidence from earlier stage of the pandemic suggests that patients with Coronavirus disease-2019 (COVID-19) are at increased risk of VTE and ATE events. However, the risk of such events with Omicron COVID-19 is less well studied, especially among people who have been infected with COVID-19 previously or received SARS-CoV-2 vaccinations. Therefore, we aim to better understand the risks of VTE and ATE events among people with COVID-19 associated with the Omicron variant.
We will first use anonymous GP records to define several groups of people, including those before the pandemic, people with COVID-19 infection, and people who received SARS-CoV-2 vaccinations. We will then look at as the number of people newly diagnosed with VTE and ATE events within each group. We will compare the numbers among people with COVID-19 and those received vaccination to people before the pandemic, and study the clinical factors related to these events. We will calculate these in specific populations based on age and sex groups.
This study will provide insight on the risk and benefit of COVID-19 vaccinations. Our findings will inform strategies for future vaccination program.
Technical SummaryBACKGROUND
Coronavirus disease-2019 (COVID-19) patients are at increased risk of venous and arterial thromboembolic events. SARS-CoV-2 variants have evolved during the COVID-19 pandemic with the dominant variant being Omicron now (as of December 2021). Information relating to thromboembolic risk and its impact on COVID-19 largely relates to COVID-19 variants occurring earlier during the pandemic.OBJECTIVES
The aim of the study is to understand the risk of venous and arterial thromboembolic events associated with COVID-19, during the Omicron period and SARS-CoV-2 vaccination, and what are the risk factors for such events.METHODS
This study will be a population-level cohort study using CPRD GOLD. We will estimate the incidence rates of venous and arterial thromboembolic events among the pre-pandemic population, among people with COVID-19 during the time when OMICRON was the dominant variant, and among People vaccinated against SARS-CoV-2. Cardiovascular events include heart failure, cardiac arrhythmia, and angina will be studied as outcomes of interest as well. We will use indirect method to estimate the standardised incidence rate ratio by comparing the rates among people with covid-19 or vaccination, to the pre-pandemic population.
We will also estimate the association between clinical risk factors and prior SARS-CoV-2 vaccination on the incidence rate of venous and arterial thromboembolic events among those with COVID-19 during the Omicron period using Cox models.Cohorts will be stratified by prior COVID-19 infection occurrence and prior SARS-CoV-2 vaccination (COVID-19 and vaccine cohorts only), age, sex. We will stratify by venous and arterial thromboembolic events history when possible. In the secondary analysis, we will look at the individual events of venous and arterial thromboembolic events.
The purposed study will generate evidence on the risk of coagulopathy in COVID-19 patients, and provide insight on the risk and benefit of COVID-19 vaccinations. Our findings will inform strategies for future vaccination program.
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Effects of the COVID-19 pandemic on primary care recorded anxiety and depression, psychotropic prescribing and referrals to mental health services — Charlotte Archer ...
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Effects of the COVID-19 pandemic on primary care recorded anxiety and depression, psychotropic prescribing and referrals to mental health services
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-09
Organisations:
Charlotte Archer - Chief Investigator - University of Bristol
Charlotte Archer - Corresponding Applicant - University of Bristol
David Kessler - Collaborator - University of Bristol
Nicola Wiles - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Exeter
Stephanie MacNeill - Collaborator - University of BristolOutcomes:
There are three primary outcomes based on three objectives for this project.
Objective 1: Trends (i.e the number of patients in each calendar month) in recorded anxiety and depression in the UK between 1st March 2020 and 30th September 2023 (or the most recent available date).
1A. We will present differences between expected rates (based on pre-COVID rates) and observed rates of recorded codes.
1B. We will present trends in recorded codes by (1) anxiety and/or depression combined; (2) anxiety only; and (3) depression only.
1C. We will present potential differences in recorded codes over time according to age, gender, region and deprivation.Objective 2: Trends (i.e the number of patients in each calendar month) in prescribing for anxiety and depression in the UK between 1st March 2020 and 30th September 2023 (or the most recent available date).
2A. We will present differences between expected rates (based on pre-COVID rates) and observed rates of prescriptions.
2B. We will present trends in prescribing by (1) anxiety and/or depression combined; (2) anxiety only; and (3) depression only.
2C. We will present potential differences in prescribing over time according to age, gender, region and deprivation.Objective 3: Trends (i.e the number of patients in each calendar month) in referrals to mental health services for anxiety and depression, in the UK between 1st March 2020 and 30th September 2023 (or the most recent available date).
3A. We will present differences between expected rates (based on pre-COVID rates) and observed rates of referrals.
3B. We will present trends in referrals by (1) anxiety and/or depression combined; (2) anxiety only; and (3) depression only.
3C. We will present potential differences in referrals over time according to age, gender, region and deprivation.Description: Lay Summary
Anxiety and depression are common mental health conditions. Medication can be prescribed to help patients with their symptoms. Antidepressants are the main drug used, although other drugs may be prescribed for anxiety. These include benzodiazepines (like valium), beta-blockers (used for high blood pressure), anticonvulsants (used for epilepsy) and antipsychotics (used for serious mental illness). Before the COVID-19 pandemic, new prescriptions for most of these drugs were increasing for patients with anxiety and depression.
Research found a decrease in the number of patients prescribed antidepressants and benzodiazepines immediately after the March 2020 'phase 1' COVID-19 'lockdown'. There was also a decrease in people diagnosed with anxiety and depression and referrals to mental health services. Diagnoses and prescriptions started to return to pre-pandemic levels around six months later. However, antidepressants and benzodiazepines have uses other than treating mental illness. As the authors did not link prescriptions to an anxiety/depression diagnosis, we do not know with certainty if these prescriptions were for anxiety/depression. We also do not know how trends for these (and other medications) may have been affected by the later pandemic 'lockdowns'. Nor how trends changed as we came out of the pandemic and into the âend of emergencyâ phase.
Therefore, we will use CPRD data to describe and understand the impact of the pandemic on diagnoses and treatment (prescribing/referrals) for anxiety and depression from March 2020 up to September 2023. This will also identify areas to explore for the future treatment for anxiety/depression.
Technical SummaryThis study will investigate the effect of the COVID-19 pandemic on trends in GP recorded anxiety and depression, and trends in treatment (prescribing/referrals) for anxiety and depression, in the UK from 1st March 2010 to 30th September 2023 (or most recent available date), and examine associated factors using a retrospective cohort design. For each calendar month we will calculate the number of patients: (1) with a new episode defined by an anxiety or depression code; (2) who started psychotropic medication (linked to an anxiety/depression code), and (3) were referred to mental health services.
Using data from 10years before March 2020, we will use negative binomial regression models to estimate expected monthly (or quarterly) incidence counts. For each month, observed and expected counts will be converted to rates using the observed person-month denominator. Monthly (or quarterly) expected rates (95%CIs) will be plotted against observed rates. Differences between expected and observed rates will be expressed as relative rate reduction (percentages with 95%CIs). Trends (codes/prescribing/referrals) over time will be examined for: (1) anxiety and/or depression combined; (2) anxiety; and (3) depression. For prescribing, for each of these three groups, data will be plotted to examine patterns of prescribing over time for all medications combined (antidepressants/anticonvulsants/benzodiazepines/antipsychotics/beta-blockers (antidepressants/antipsychotics/anticonvulsants only for group 3)), and separately for SSRIs. Data will be stratified by age, gender, region and deprivation. Joinpoint analysis will also be used to explore key timepoints in the data. Findings will be reported separately for children and adults.
The study will provide valuable insight into trends in GP recorded anxiety and depression, and treatment for these conditions, during the COVID-19 pandemic. Findings will inform further research on the impact of the pandemic and remote consulting on patients with anxiety or depression, and will identify areas to explore in terms of future treatment for these conditions.
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The associations between antihypertensive medications and microvasucalar, macrovascular diseases and major adverse cardiovascular event (MACE) in people with type 2 diabetes: a population-based cohort study — Jingya Wang ...
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The associations between antihypertensive medications and microvasucalar, macrovascular diseases and major adverse cardiovascular event (MACE) in people with type 2 diabetes: a population-based cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-18
Organisations:
Jingya Wang - Chief Investigator - University of Birmingham
Luyuan Tan - Corresponding Applicant - University of Birmingham
Alastair Denniston - Collaborator - University of Birmingham
Christopher Sainsbury - Collaborator - University of Birmingham
Francesca Crowe - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of BirminghamOutcomes:
Primary outcome:
1. Composite microvascular diseases: sight-threatening diabetic retinopathy (STDR), chronic kidney disease (CKD) 3-5 with microalbuminuria, and diabetic foot diseases (DFD).
2. Composite macrovascular diseases: ischemic heart disease (IHD), myocardial infarction (MI), stroke and transient ischaemic attack (TIA), heart failure (HF); aortic diseases, peripheral arterial disease (PAD), and chronic kidney disease (CKD) 3-5 without microalbuminuria.
3. Composite major adverse cardiovascular event (MACE): IHD, MI, stroke and TIA, HF.Secondary Outcomes:
1. IHD
2. MI
3. stroke and TIA
4. HF
5. Aortic diseases
6. PAD
7. CKD 3-5 without microalbuminuria
8. STDR
9. CKD 3-5 with microalbuminuria
10. DFD
11. Vascular dementia
12. All-causes mortality
Analyses for all different seconary outcomes will be analysed separately.Description: Lay Summary
About 80% of people with type 2 diabetes, the sugar control problem caused by the body not making enough insulin, also have high blood pressure, which increases their risk of developing diseases related to the blood vessels, including problems with the heart, brain, and small blood vessels. In the UK, the National Institute for Health Care Excellence (NICE) recommends that people with type 2 diabetes and high blood pressure should take drugs known as angiotensin-converting enzyme inhibitors (ACEis) or angiotensin receptor blockers (ARBs) to help manage their conditions. However, other guidelines provided different suggestions.
Previous studies provided inconsistent results on effects of blood pressure drugs on diseases related to the blood vessels in people with type 2 diabetes. Therefore, our study aims to investigate how different blood pressure drugs, ACEis, ARBs, calcium channel blockers (CCBs), and thiazide diuretics (thiazides), affect the blood vessels of people with type 2 diabetes. We will analyse medical records from the CPRD primary care database to gather information on the effects of these drugs. By studying real-world data, we hope to gain a better understanding of the benefits of these blood pressure drugs and how they can help people with type 2 diabetes stay healthy. This study will provide robust evidence to help patients, society, and the National Health Service (NHS) make decisions regarding which blood pressure drugs may be more suitable for people with type 2 diabetes and high blood pressure, considering their different conditions.
Technical SummaryAims:
To assess the associations between ACEis, ARBs, CCBs, or thiazides and the risks of macro-/microvascular diseases and vascular dementia in people with type 2 diabetes.Methods/design:
We will perform a series of cohort studies with the new user design.Participants:
Individuals who have a diagnosis of type 2 diabetes aged 18 years and over and have been initiated commonly prescribed antihypertensive drugs (ACEis, ARBs, CCBs, or thiazides) will be eligible for this study.Exposures: The use of ACEis, ARBs, CCBs, and thiazides will be compared side-by-side..
Outcomes:
Primary outcomes:
1. Composite microvascular diseases, including sight-threatening diabetic retinopathy (STDR), chronic kidney disease (CKD) 3-5 with microalbuminuria, and diabetic foot diseases (DFD)
2. Composite macrovascular diseases, including ischemic heart disease (IHD), myocardial infarction (MI), stroke and transient ischaemic attack (TIA), heart failure (HF); aortic diseases, peripheral arterial disease (PAD), and CKD 3-5 without microalbuminuria
3. Composite major adverse cardiovascular event (MACE), including IHD, MI, stroke and TIA, HF
Secondary outcomes include IHD, MI, stroke and TIA, HF, aortic diseases, PAD, CKD 3-5 with microalbuminuria, STDR, CKD 3-5 without microalbuminuria, DFD, vascular dementia, and all-cause mortality. Analyses for different outcomes will be analysed separately.Covariates
Sociodemographic characteristics, diabetes-related characteristics, comorbidities, biomarkers, and drug prescriptions will be adjusted to account for residual confounding.Analytical methods:
Except for the outcome of all-cause mortality, competing risk Cox proportional hazard regression models will be used to calculate crude and adjusted hazard ratios, together with their corresponding 95% CIs.
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Long-term mortality, neurodevelopmental impairments, and economic outcomes after invasive group B streptococcal disease in the first three months of life in England: A retrospective cohort study based on electronic health care records — Felix Achana ...
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Long-term mortality, neurodevelopmental impairments, and economic outcomes after invasive group B streptococcal disease in the first three months of life in England: A retrospective cohort study based on electronic health care records
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-02
Organisations:
Felix Achana - Chief Investigator - University of Oxford
Felix Achana - Corresponding Applicant - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Jane Daniels - Collaborator - University of Nottingham
Jane Plumb - Collaborator - Not from an Organisation
Jason Madan - Collaborator - University of Warwick
Kate Walker - Collaborator - University of Nottingham
Linda Fiaschi - Collaborator - University of Nottingham
Margaret Smith - Collaborator - University of Oxford
May Ee Png - Collaborator - University of Oxford
Proma Paul - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Shalini Ojha - Collaborator - University of Nottingham
Stavros Petrou - Collaborator - University of OxfordOutcomes:
(1) All-cause mortality at 1, 5, 10, and 15 years of life will be assessed based on ONS mortality data. We will consider assessing mortality over 20 years if the data allows it.
(2) Neurodevelopmental impairments (NDIs) at 1, 5, 10, 15 and 20 years of age (if the data allows) across motor, hearing, vision, cognitive, and social or behavioural domains.
(3) Healthcare resource use and costs at 1, 5, 10, 15 and 20 years of age (if the data allows). Primary care data will include the number and type of consultations with each health care professional, prescriptions, tests and investigations. Secondary care utilisation includes referral, type of admission, length of stay, diagnosis, and procedures undertaken.Description: Lay Summary
Group B streptococcus (GBS) is a common cause of severe infection in newborns. It can be passed from mother to baby during labour, and from mothers and others after birth. Most babies colonised with GBS remain well, but some develop GBS infection, usually in the first two days after birth. To reduce the risk of newborn infection, antibiotics can be given to the mother during labour. However, the long-term effects of antibiotics are unknown, and giving antibiotics may contribute to antibiotic resistance.
To determine whether routine testing for GBS in late pregnancy or during labour is effective and cost-effective, the National Institute for Health Research is funding a large study (GBS3) led by the University of Nottingham. The study will provide evidence to the UK National Screening Committee on whether all women should be offered GBS testing in pregnancy or around birth.
To ensure GBS3's findings reflect both the immediate and long-term consequences for babies who develop GBS infection, the study will use mathematical modelling to estimate outcomes through childhood years. To do this, the study will link and assess routinely collected English data from three datasets: the Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES), and the Office for National Statistics.
Technical Summary
The aim of the study is to measure and compare survival, health-related quality of life, and healthcare needs of individuals who had and did not have GBS infection as a baby. This will help researchers better understand the long-term outlook for babies who develop GBS infection.Group B streptococcus (GBS) is a bacterium that colonises the vagina and lower gut of approximately 1 in 4 pregnant women. Although most babies colonised with GBS remain well, approximately one baby in every 1750 will develop GBS infection within 7 days of birth. In the UK, about 40 babies die each year, and 1 in 14 survivors have long-term disability. Intrapartum Antibiotic Prophylaxis (IAP) reduces the risk of mother to baby transmission during labour, but concerns remain about their long-term effects and antimicrobial resistance.
To fill the evidence gap around maternal GBS testing, the National Institute for Health Research (NIHR) has funded a large cluster-randomised controlled trial (GBS3) involving approximately 320,000 participants. The trial will assess whether routine testing of women for GBS colonisation in late pregnancy reduces early-onset neonatal sepsis compared with the current risk-based approach.
An economic evaluation is being conducted alongside GBS3 to extrapolate cost-effectiveness over a lifetime horizon. Recently published data from Denmark and the Netherlands suggest an increased risk of 5-year mortality and neurodevelopmental impairments for children who had infant GBS disease compared to children without the disease. However, their estimates of resource use associated with the disease do not reflect UK practice due to differences in healthcare practices.
In this study, we aim to generate evidence using English data to model progression of infant GBS disease and its impact on health, wellbeing and healthcare use of survivors over time. We will construct a cohort of individuals who had infant disease and a comparison group without infant disease, using CPRD, HES, and ONS data. We will use the cohorts to estimate excess mortality and neurodevelopmental impairments over childhood and adolescent years and healthcare costs for survivors. The study findings can inform other studies, such as those modelling cost-effectiveness of vaccines currently in development.
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Effectiveness and safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation and mitral stenosis — Li Wei ...
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Effectiveness and safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation and mitral stenosis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-19
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Chengsheng Ju - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Vincent Ka Chun Yan - Collaborator - University College London ( UCL )Outcomes:
Primary outcomes: composite of ischemic stroke or systemic embolism
Secondary outcomes: ischemic stroke, systemic embolism, intracranial haemorrhage, gastrointestinal bleeding, all-cause mortalityDescription: Lay Summary
Patients with irregular heart rhythm (especially those who also have narrowing of the valve between the two left heart chambers) have higher risks of brain attack and require blood-thinning medications to prevent them. Direct oral anticoagulants (DOACs) and warfarin are commonly used for this purpose. In patients without narrowing or replacement of heart valve, DOACs are currently preferred over warfarin since it is safer and more effective. However, individuals with narrowing of heart valve were largely excluded from randomised clinical trials of DOACs, thus whether DOACs are safe and effective compared to warfarin for these individuals remains unclear. This study aims to compare DOACs versus warfarin on the risks of brain attack and bleeding in people with irregular heart rhythm and also narrowing of heart valve. The findings will help clinicians to make medication management decision on whether to prescribe or switch to DOACs for preventing brain attack in these patients.
Technical SummaryThis study aims to compare DOACs versus warfarin on the risks of stroke and bleeding in patients with atrial fibrillation and mitral stenosis. Patients aged â¥18 years with mitral stenosis and received DOACs or warfarin in 2010-2022 will be included. Target trial emulation with prevalent new user design will be adopted. At each calendar month during the study period (i.e., index date), eligible patients without prior use of DOACs are included. Those receiving a prescription of any DOAC (or warfarin) during the index month are categorized as the DOAC (or warfarin) group. Each patient in the DOAC group will be matched with four patients in the warfarin group according to the duration of prior warfarin exposure, and followed up till outcome occurrence, death, or end of study (31 December 2022). Outcomes of interest include ischemic stroke, systemic embolism, intracranial haemorrhage, gastrointestinal bleeding, and all-cause mortality.
Inverse probability of treatment weighting (IPTW) with propensity score will be used to minimise potential confounding. Covariates including age, sex, ethnicity, smoking status, deprivation index, CHA2DS2-VASC score, comorbidities, concomitant chronic medications, and clinical parameters will be adjusted for. Weighted pooled logistic regression will be used to estimate the hazard ratio and absolute risk differences. Additionally, patients will be censored on treatment switch or discontinuation during per-protocol analyses, and stabilised inverse probability of censoring weighting will be used to account for the potential bias.
Subgroup analyses will be conducted by age group, sex, CHA2DS2-VASC score, prior stroke or systemic embolism, prior bleeding, PPI/H2RA exposure. Sensitivity analyses restricting to incident new users without prior warfarin exposure in the DOAC group, and positive control analyses in patients with other valvular heart diseases will be conducted. Findings shall provide evidence on whether DOACs are safe and effective compared to warfarin for stroke prevention in AF-MS population.
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD) — Jessie Oyinlola ...
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Incidence of stroke in patients with epilepsy using anti-seizure medication in England: A retrospective cohort study conducted within the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-13
Organisations:
Jessie Oyinlola - Chief Investigator - CPRD
Eleanor Axson - Corresponding Applicant - CPRD
Chisomo Mutafya - Collaborator - CPRD
Daphne Martin - Collaborator - CPRDOutcomes:
Incidence of stroke among patients with epilepsy
Description: Lay Summary
Over the last few years, organisations who make data available for public health research have been looking for ways to improve data sharing and security among users of the data. One approach that has been recommended in the UK is the use of platforms which allow access to data so analysis can be performed but limited outputs (e.g. aggregated results) can be exported. CPRD are working to establish such a platform for its users. However, it is key that the platform still enables vital health research to be performed. To help assess this, a study looking at epilepsy and stroke will be conducted.
Epilepsy is the name for a group of chronic conditions which result in repeated seizures and affects people of all ages, genders and ethnicities. Epilepsy has been linked to other conditions, including stroke. However, studies in this area have been limited and not recent.
The aims of this study are to provide more updated information on the statistics of stroke in epileptic patients while also assessing if important research can be conducted in CPRDâS secure platform. As there is a drive for more organisations to use such platforms, this research will benefit public health by ensuring such methods do not hamper research using CPRD data.
Technical SummaryThe main aim of this study is to calculate the incidence of stroke among patients with epilepsy who were prescribed anti-seizure medication. This research will benefit public health by presenting an updated picture of the disease in the UK thus highlighting areas of improvement in the management of such patients and suggesting areas for further research.
This is a retrospective cohort study of epileptic patients prescribed anti-seizure medication with an incident record of stroke between 01/012010-31/12/2019 in their primary or secondary care data record.
The CPRD primary care data will be used for defining the study population. This will also be linked to the Hospital Episode Statistics Admitted Patient Care (HES APC) data (for defining the outcome of stroke), Office for National Statistics (ONS) Death Registration data (for defining the outcome of stroke and the date of death), and patient-level Index of Multiple Deprivation (IMD) data (as a covariate).
Descriptive results will be presented for patient demographics and incidence rates will also be calculated as the number of newly diagnosed stroke events in patients with epilepsy (numerator) divided by the sum of the person years of follow-up of epileptic patients during each calendar year of interest. The rates will be stratified by age group, gender, and year of stroke diagnosis.
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Patient characteristics and treatment patterns in patients with asthma newly initiating Inhaled Corticosteroid (ICS) and Long-acting beta 2 agonist (LABA) combination inhalers in UK clinical practice — Shalini Girotra ...
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Patient characteristics and treatment patterns in patients with asthma newly initiating Inhaled Corticosteroid (ICS) and Long-acting beta 2 agonist (LABA) combination inhalers in UK clinical practice
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-09
Organisations:
Shalini Girotra - Chief Investigator - GSK
Alexander Ford - Corresponding Applicant - Adelphi Real World
Bethany Backhouse - Collaborator - Adelphi Real World
Ines Palomares - Collaborator - GSK
Neha Shah - Collaborator - GSK
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real World
Thomas Paulsson - Collaborator - GSK
Zohaib Akhter - Collaborator - Adelphi Real WorldOutcomes:
Sociodemographic and clinical characteristics; asthma exacerbations; treatment patterns; dosage changes; healthcare resource utilisation (including GP visits, inpatient stays, outpatient visits, and emergency department visits)
Description: Lay Summary
Asthma is a common lung disease which causes breathing difficulties. It affects around 339 million individuals and causes approximately 461,000 deaths worldwide each year. Patients who have asthma may also report chest tightness, wheezing, a cough and symptom flare-ups (exacerbations).
There are a range of drugs that are available for the treatment of asthma in the UK. To help prevent exacerbations, patients can be given inhaler treatments containing a combination of two types of drugs, taken together as part of a single inhaler. One type of this inhaler available to patients with asthma in the UK, includes a combination of inflammation preventing steroids (ICS) and long acting drugs (LABA) which relax the airways; these inhalers are termed ICS/LABA inhalers. All ICS/LABA inhalers are intended to be used daily to prevent symptoms over an extended period of time. There are a range of ICS/LABA therapies available to patients with asthma in the UK, including fluticasone furoate/vilanterol (FF/VI), budesonide/formoterol (BUD/FOR) and beclomethasone dipropionate/formoterol fumarate (BDP/FOR).
This study aims to describe the characteristics of patients with asthma in the UK who are first-time users of these ICS/LABA inhalers, including clinical characteristics, such as smoking status, medications they received before and after ICS/LABA treatment, how frequently they used healthcare services before ICS/LABA treatment, and how frequently they experienced exacerbations before ICS/LABA treatment. The results of this study may be used to help design future research in comparing how effective different ICS/LABA inhalers are for patients with asthma in the UK.
Technical SummaryAim: The aim of this study is to describe the characteristics and treatment patterns of patients with asthma who are newly initiating the following inhaled corticosteroid/long-acting beta antagonist (ICS/LABA) therapies; Fluticasone furoate/vilanterol (FF/VI), budesonide/formoterol (BUD/FOR) and beclomethasone dipropionate/formoterol fumarate (BDP/FOR).
Objectives: To: i) describe the characteristics of patients with asthma in England in the year prior to newly initiating ICS/LABA therapy; ii) describe seasonal trends in rate of moderate-to-severe exacerbations in asthma patients in England after initiating ICS/LABA therapy; iii) describe treatment patterns following initiation of the ICS/LABA therapy, including respiratory treatment classes prescribed and changes in ICS dosage; iv) describe the suitability of CPRD-HES for future research using treatment groups of patients with asthma initiating FF/VI, BUD/FOR or BDP/FOR, balanced using a propensity score matching model
Methods: A retrospective cohort study to describe characteristics of asthma patients using linked data sources. Patients will be indexed on initiation of ICS/LABA during 1st December 2015 to 28th February 2019, with a minimum of 12 months baseline and follow up available.
Exposures: Patients with asthma in England, newly initiating FF/VI, BDP/FOR or BUD/FOR ICS/LABA therapies.
Outcomes: Pre-index: Sociodemographic and clinical characteristics, asthma exacerbations, treatment patterns and healthcare resource use; Post-ICS/LABA initiation: Asthma exacerbations, treatment patterns
Data Analysis: For descriptive analysis, counts, means, medians, standard deviation (SD), 25th and 75th percentile values will be reported for continuous variables, whilst relative frequencies and proportions/percentages for categorical variables. For the propensity score matching model (in which no outcomes will be derived), an entropy balancing based methodology will be implemented to minimise confounding and evaluate the treatment effect in the entire population.
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The efficacy and safety of concomitant treatment with telmisartan and indapamide in patients with essential arterial hypertension: Outcomes in real world practice — Christopher Morgan ...
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The efficacy and safety of concomitant treatment with telmisartan and indapamide in patients with essential arterial hypertension: Outcomes in real world practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-17
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
- Corresponding Applicant -
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Irena Orel - Collaborator - Krka - Slovenia
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Redenšek Trampuž - Collaborator - Krka - Slovenia
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Mean change in systolic blood pressure (SBP); mean change in diastolic blood pressure (DBP), proportion of patients with SBP <140 mm Hg; proportion of patients with DBP <90 mm Hg; proportion of patients with SBP reduction from baseline ⥠20 mm Hg, proportion of patients with DBP reduction from baseline ⥠10 mm Hg; adverse events (to be reported by individual event type, by site and overall): urinary tract infections, upper respiratory tract infection, sepsis, anaemia, eosinophilia, thrombocytopenia, anaphylactic reaction, hypersensitivity, hyperkalaemia, hypoglycaemia (in diabetic patients), insomnia, depression, anxiety, syncope, somnolence, vision disturbance, vertigo, bradycardia, tachycardia, hypotension, orthostatic hypotension, dyspnoea, cough, interstitial lung disease, abdominal pain, diarrhoea, dyspepsia, flatulence, dry mouth, stomach discomfort, dysgeusia, hepatic function abnormal/liver disorder, pruritus, hyperhidrosis, rash, angioedema, eczema, erythema, urticaria, drug eruption, toxic skin eruption, back pain, muscle spasms, myalgia, arthralgia, pain in extremity, tendon pain (tendinitis like symptoms), renal impairment, chest pain, asthenia (weakness), influenza-like illness, blood creatinine increased, haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased, agranulocytosis, aplastic anaemia, haemolytic anaemia, leucopenia, hypercalcaemia, hypokalaemia, hyponatraemia, hypochloraemia, hypomagnesaemia, fatigue, headache, paraesthesia, myopia, visual impairment, acute angle-closure glaucoma, choroidal effusion, arrhythmia, torsade de pointes, vomiting, nausea, constipation, pancreatitis, onset of hepatic encephalopathy, hepatitis, hypersensitivity reactions, maculopapular rashes, purpura,, toxic epidermal necrolysis, Stevens-Johnson Syndrome, worsening of pre-existing acute disseminated lupus erythematosus, photosensitivity reactions, muscular weakness, rhabdomyolysis, erectile dysfunction, electrocardiogram QT, bBlood glucose increased.
Description: Lay Summary
Patients with hypertension (high blood pressure) are at increased risk of heart attacks, strokes and kidney disease. It is a relatively common condition, affecting approximately 30% of adults in the United Kingdom. Initially, patients with hypertension may be recommended lifestyle and dietary changes, but if this fails to reduce blood pressure to an acceptable level, then patients may be prescribed blood pressure lowering tablets. Various types of tablets exist that tackle hypertension in different ways and patients may add a second blood pressure tablet to their first if their blood pressure remains too high. Combining two types of medication in one tablet may help patients to remember to take the tablets. In this study we want to use the Clinical Practice Research Datalink database to see what happens to blood pressure when patients initially taking one of two drugs (telmisartan or indapamide) have the other drug added. We will compare blood pressure at a baseline (before the second drug is added) to two subsequent timepoints (30â150 days and 90â270 days). We will also see if these patients have side-effects in the 12 months after taking the two drugs together and compare them to other patients on the same initial drug who have a different drug added. If this study shows that the use of the drugs in combinations is effective and safe, it may provide evidence to support combing the drugs in a single tablet which may improve patient outcomes and provide savings for healthcare services.
Technical SummaryHypertension is a common condition that is associated with increased cardiovascular and renal complications. Adding a second class of anti-hypertensive therapy to a patientâs regimen may have an additive effect when blood pressure remains uncontrolled by the initial therapy. We will conduct a retrospective, cohort study in the Clinical Practice Research Datalink GOLD and Aurum databases to evaluate the efficacy and safety of combination telmisartan/indapamide therapy. Patients with a history of essential arterial hypertension prescribed stable dose telmisartan or indapamide who have the other therapy added will form the study cohort. Index date will be the date that telmisartan and indapamide are prescribed concomitantly. Patients prescribed other antihypertensives will be eligible provided their therapy is not initiated or modified in the month prior to index date. A reference group whose antihypertensive therapy (telmisartan or indapamide) is augmented with a different antihypertensive agent will be matched for safety evaluation. Telmisartan will be considered in two different strengths and results presented separately and compared. Blood pressure will be recorded at baseline and compared to two subsequent timepoints (30â150 and 90â270 days after index date) using the dependent t t-test. Comparison of groups based on dosage will use the independent t-tests. Non-parametric equivalents will be used if the distribution is not normal. The proportion of patients reaching targets (blood pressure reduction of >20 mmHg (systolic), >10 mmHg (diastolic) or achieving <140 mmHg (systolic) or <90 mmHg (diastolic)) will be reported. The incidence of safety events will be reported in the year post index and compared to the reference group by incidence rate ratios evaluated by the mid-p test. This study will provide valuable data that will assist in the potential development of a fixed dosed combination therapy and inform the impact on outcomes with ultimate efficiencies for health services.
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Long term cardiovascular safety of febuxostat compared with allopurinol or no urate-lowering treatment in patients with gout: a cohort study in UK primary care using the Clinical Practice Research Datalink. — Richard Partington ...
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Long term cardiovascular safety of febuxostat compared with allopurinol or no urate-lowering treatment in patients with gout: a cohort study in UK primary care using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-20
Organisations:
Richard Partington - Chief Investigator - Keele University
Richard Partington - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Edward Roddy - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Payam Amini - Collaborator - Keele University
Sara Muller - Collaborator - Keele University
Subhashisa Swain - Collaborator - Keele UniversityOutcomes:
Primary outcome:
Composite of first incidence of (MI; unstable angina; cerebrovascular accident (CVA); heart failure; revascularisation; death due to CV event.)Secondary outcomes:
Non-fatal events considered separately (MI, unstable angina, CVA, heart failure, revascularisation); CV deathsDescription: Lay Summary
Gout affects approximately 1 in 40 people and causes sudden flares of severe joint pain and swelling. Many people with gout experience recurrent flares. Gout is caused by high levels of urate in the blood. Long-term treatment of gout involves taking medication to lower urate levels, which reduces the risk of future flares.
Two medications are available to reduce urate levels: allopurinol and febuxostat. Allopurinol has been used for more than 50 years. However it is often given at too low a dose, or not at all, and around 1 in 20 people canât take allopurinol due to side effects. An alternative, febuxostat, was authorised for use in 2008, and is potentially more effective for the treatment of gout. However, early research studies suggested febuxostat may increase the risk of heart attacks and strokes. Current guidance in the UK advises caution when using febuxostat in people with pre-existing heart disease or strokes.
Using the Clinical Practice Research Datalink (CPRD), we will form a group of patients with gout, who are given either febuxostat, allopurinol or nothing to find out two things.
Technical Summary
⢠If the risk of heart attacks and strokes is bigger when people start taking febuxostat for gout than when they take allopurinol or no treatment?
⢠If people who have had a heart attack or stroke in the past, or those who have a high risk of them, are have a bigger chance of heart attacks or strokes when taking febuxostat than people given allopurinol or no treatment?Gout affects 2.5% of adults in the UK and causes flares of severe joint pain and swelling. Flares can be prevented by urate lowering therapy (ULT), either allopurinol or febuxostat. The most-commonly prescribed ULT is allopurinol, however only one-third of people with gout receive treatment, only one-third of these receive a sufficient dose, and 5% have side-effects severe enough to stop therapy. Febuxostat is a newer alternative. However initial trials raised concerns that febuxostat was associated with an increased risk of cardiovascular events.
The Medicines and Healthcare products Regulatory Agency (MHRA) advises caution when using febuxostat in patients with prior major cardiovascular (CV) events. Gout is associated with CV events, hence a significant proportion of people who cannot tolerate allopurinol have no alternative treatment. It is therefore important to establish the cardiovascular safety of febuxostat.
Objectives:
1. Determine the risk of adverse major CV events following febuxostat treatment for gout in UK primary care, compared to treatment with allopurinol or no treatment.
2. Compare the incidence of major CV events between people initiating febuxostat, allopurinol, or no ULT in (1) people with gout but no CV events and low CV risk, or (2) those with increased CV risk but no events, and (3) those with a prior history of CV events.The study will be undertaken using linked primary care and Hospital Episodes Statistics data.
Work-package 1
A retrospective cohort study will compare the incidence of major CV events using Cox proportional hazards regression between people with gout who initiate treatment with febuxostat, allopurinol or no ULT.Work-package 2
A retrospective cohort study to compare the incidence of major CV events using Cox proportional hazards regression between people with gout who initiate treatment with febuxostat, allopurinol or no ULT, subcategorised by risk of cardiovascular disease at time of prescription.
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Characterising rectal prolapse and rectopexy in the United Kingdom: population characteristics, incidence and surgical procedures — Katherine Donegan ...
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Characterising rectal prolapse and rectopexy in the United Kingdom: population characteristics, incidence and surgical procedures
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-30
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Helen Booth - Corresponding Applicant - CPRD
Daniel Dedman - Collaborator - CPRD
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
Objective 1: Rectal prolapse
Objective 2: Rectopexy
Objective 3: (a) Short-term complications of rectopexy requiring readmission, relating to pain, haemorrhage, procedure or device; (b) further procedure relating to rectopexyDescription: Lay Summary
Rectal prolapse occurs when part of the large intestine slips out through the anus. Symptoms can include incontinence and constipation. Treatment is mainly surgical, with a variety of approaches used and no clear agreement on the most effective method. One of the procedures involves use of a mesh device to secure the rectum in place. The risk of complications from the surgical procedure (called a rectopexy), or from the mesh when itâs used, is not well understood. Current evidence on safety of rectopexy procedures is based on small studies that might not represent the whole population well.
The aim of this study is to improve our understanding of rectal prolapse and its treatment, including use of mesh and subsequent complications. To do this we will use hospital data to find patients who have a diagnosis of rectal prolapse or rectopexy and describe their characteristics such as age, sex and type of surgical treatment. For those who underwent surgery, we will investigate how many patients experience a short-term complication requiring admission to hospital, such as infection or pain at the operation site, or who require a re-operation with a year. This study will improve our understanding of the patients who get rectal prolapse and how they are treated. It will also increase our knowledge of the risks associated with rectopexy procedures.
Technical SummaryRectal prolapse can be treated with a variety of surgical approaches (rectopexy), encompassing different access points, use of mesh or sutures and resection of the colon. Where biological or synthetic mesh is implanted there is a risk of mesh-related or procedural complications that are not yet well-quantified.
The aim of this study is to increase understanding on the epidemiology of rectal prolapse and its surgical management, with a particular interest in procedures involving insertion of mesh. The objectives are (1) To describe the epidemiology of rectal prolapse over the study period (01/01/2013 to 31/03/2021), including (a) incidence and prevalence, and (b) baseline characteristics (age, sex, prolapse symptoms); (2) To describe the use of rectopexy over the study period, including trends over time (stratified by procedure type, age and sex) and baseline characteristics; (3) To estimate the risk of short-term (90 days) postoperative complications or further related procedures up to one year post-index surgery.
Retrospective patient cohorts will be selected on the basis of a diagnostic code for rectal prolapse (obj 1) or procedural code for rectopexy (obj 2) using hospital admissions data. Incidence and prevalence will be calculated for rectal prolapse (obj 1) and rectopexy (obj 2), and baseline characteristics tabulated for each cohort. For objective 3, incidence of complications requiring admission (infection, pain) up to 3 months after the index procedure will be calculated. Rectopexy re-operation rate up to one year after index procedure will be explored with survival analysis using the Kaplan-Meier method.
This study will improve understanding of the epidemiology of rectal prolapse and its surgical management. It will increase our knowledge of the risks associated with rectopexy procedures, including those that involve mesh insertion.
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Autism, epilepsy and central sensitivity syndromes: investigating the co-occurrence of conditions associated with increased brain excitation : inhibition balance — Alex Dregan ...
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Autism, epilepsy and central sensitivity syndromes: investigating the co-occurrence of conditions associated with increased brain excitation : inhibition balance
Datasets:GP data, Primary outcomes:
Diagnosis of: epilepsy, specific epilepsy syndromes, and febrile seizures.
Diagnosis of central sensitivity syndromes, including: fibromyalgia, irritable bowel syndrome, migraines, chronic fatigue syndrome, restless leg syndrome, immune dysregulation, and temporomandibular disorders. Secondary outcomes:
Morbidity: all-cause hospitalisation (ever hospitalised, number of hospitalisations, and length of
hospitalisations); seizure/epilepsy-related hospitalisation (ever hospitalised, number of
hospitalisations, and length of hospitalisations); CSS-related hospitalisation (ever hospitalised,
number of hospitalisations; drug-resistant epilepsy, epilepsy related surgery (yes/no, number of
surgeries); CSS related surgery (yes/no, number of surgeries); number of status epilepticus
events; new diagnosis of mental health condition after receiving diagnosis of epilepsy/seizures or
CSSs; number of anti-seizure medications prescribed; epilepsy-related surgery; brain surgery.
Mortality: all-cause mortality; seizure/epilepsy-related death.Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-18
Organisations:
Alex Dregan - Chief Investigator - King's College London (KCL)
Chirag Mehra - Corresponding Applicant - King's College London (KCL)
Carrie Allison - Collaborator - University of Cambridge
Dwaipayan Adhya - Collaborator - University of Cambridge
Elizabeth Weir - Collaborator - University of Cambridge
Jonathan O'Muircheartaigh - Collaborator - King's College London (KCL)
Simon Baron-Cohen - Collaborator - University of CambridgeOutcomes:
Primary outcomes:
Diagnosis of: epilepsy, specific epilepsy syndromes, and febrile seizures.
Diagnosis of central sensitivity syndromes, including: fibromyalgia, irritable bowel syndrome, migraines, chronic fatigue syndrome, restless leg syndrome, immune dysregulation, and temporomandibular disorders.Secondary outcomes:
Morbidity: all-cause hospitalisation (ever hospitalised, number of hospitalisations, and length of
hospitalisations); seizure/epilepsy-related hospitalisation (ever hospitalised, number of
hospitalisations, and length of hospitalisations); CSS-related hospitalisation (ever hospitalised,
number of hospitalisations; drug-resistant epilepsy, epilepsy related surgery (yes/no, number of
surgeries); CSS related surgery (yes/no, number of surgeries); number of status epilepticus
events; new diagnosis of mental health condition after receiving diagnosis of epilepsy/seizures or
CSSs; number of anti-seizure medications prescribed; epilepsy-related surgery; brain surgery.
Mortality: all-cause mortality; seizure/epilepsy-related death.Description: Lay Summary
Autistic people experience many co-occurring physical health conditions at a higher rate than the general population. These include conditions that impact on quality of life, such as pain syndromes (including irritable bowel syndrome, chronic headache, and pelvic pain syndromes) and those that decrease life expectancy, such as epilepsy. Indeed, epilepsy is the leading cause of death in autistic people with an intellectual disability. Despite this, little is known about why these conditions co-occur, and which autistic people are at increased risk of developing these conditions. These questions have been highlighted as research priorities by autistic people.
Here, we address both these questions by uniquely investigating co-occurring autism, epilepsy and pain syndromes in a large population-based dataset. Previous research has initially linked each of these conditions with increased brain excitability. By studying these conditions together, we investigate increased brain excitability as a potential cause of this co-occurrence. Then, we investigate the characteristics that predispose autistic individuals to pain syndromes or epilepsy. Uniquely, we investigate if the occurrence of febrile seizures (seizures that occur during a fever) in childhood is a meaningful predictor of future epilepsy in autistic people. Finally, we investigate the impact of having these conditions on the quality and quantity of life of autistic people, including their contribution to mental health challenges.
Therefore, our proposal addresses both a potential mechanism of co-occurring physical health conditions in autistic people - enabling the development of better treatments - and may enable better prediction of future physical health issues, informing resource allocation.
Technical SummaryWe will use the Clinical Practice Research Datalink (CPRD), alongside linkages to the Hospital Episode Statistics (Admitted Patient Care data), Hospital Episode Statistics (Accident & Emergency data), and Office of National Statistics (ONS) Death registry to better understand the associations between three conditions that are associated with increased brain excitation / inhibition balance, namely autism, seizures, and central sensitivity syndromes (CSSs). We will use clinical, therapy, and test records to (1) further describe the seizure disorders and epilepsies that co-occur with autism, (2) understand whether febrile seizures in early childhood are predictors of later epilepsy in autistic people, and (3) determine whether autistic individuals have increased rates of CSSs. We will consider whether autistic people with these conditions are more likely to have negative long-term outcomes, such as hospitalisation and death. Cohort 1 will consist of all individuals with a code for autism (Appendix 1) between January 1st, 1995 and June 30th, 2023; they will be matched 2:1 to two cohorts (Cohorts 2 and 3). Cohort 2 will be non-autistic individuals matched on age, gender, and GP practice. Cohort 3 will be non-autistic individuals matched on age, gender, GP practice, and epilepsy status. We will use cox regression, binomial logistic regression, and other descriptive statistics (e.g., chi-square, Mann-Whitney U tests) to understand the prevalence, characteristics, and outcomes of each of the aforementioned conditions between Cohorts 1 vs. 2, and Cohorts 1 vs.3. We will co-vary for confounding and moderating factors including sex, GP practice, intellectual ability, ethnicity, and will use the Patient-Level Indices of Multiple Deprivation (IMD) linkage to account for socioeconomic status.
Our proposal addresses both a potential mechanism of co-occurring physical health conditions in autistic people - enabling the development of better treatments - and may enable better prediction of future physical health issues, informing resource allocation.
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Analysis of chronic multimorbidity in observational data: part of the GEMINI study. — Timothy Frayling ...
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Analysis of chronic multimorbidity in observational data: part of the GEMINI study.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-02
Organisations:
Timothy Frayling - Chief Investigator - University of Exeter
Joao Delgado - Corresponding Applicant - University of Exeter
Chris Fox - Collaborator - University of East Anglia
David Melzer - Collaborator - University of Exeter
Jane Masoli - Collaborator - University of Exeter
Luke Pilling - Collaborator - University of Exeter
Olivia Murrin - Collaborator - University of Exeter
Sara Khalid - Collaborator - University of Oxford
Sarah Lamb - Collaborator - University of Exeter
Seyed Alireza Hasheminasab - Collaborator - University of OxfordOutcomes:
Common Disease Pairs; All Cause Hospitalisation; All-Cause Mortality; Falls; Fractures; Frailty; Charlson Comorbidity Score; Disability dichotomised from Activities of Daily Living assessment; Pneumonia; Sepsis; UTI; Care home admission; Pain medications; potentially Inappropriate prescribing; Exacerbation within Common disease pairs.
Description: Lay Summary
More than half of people over 65 live with multiple long-term health conditions. Studying multiple conditions is complex. Many trials focus on single health conditions, and people with multiple conditions are often excluded. This means that clinical guidance focuses on single conditions with little guidance for people with multiple long-term conditions.
Technical Summary
This project investigates possible links between long-term conditions to try to understand causes and health impacts. We hope this will help to understand why conditions occur in the same person and why some people have worse outcomes than others. It might also help to find new potential treatments.
We have organised patient and public involvement and engagement workshops. These workshops will focus on prioritizing pairs of conditions that are often experienced together. We will look at these pairs of conditions to explore shared risk factors, genetics, and how having both conditions affect a person's health. We will also examine what puts individuals at risk of developing the second condition if they already have one. The insights gained from these workshops will help us determine important outcomes for each pair of conditions.
The results of our work will help healthcare providers better understand the risks associated with developing multiple long-term conditions. This would also prompt future clinical trials for medicines already in use for one condition that might help to improve patient outcomes for different conditions.GEMINI (Genetic Evaluation of Multimorbidity towards INdividualisation of Interventions) is a large, multicentre international research project funded by the Medical Research Council (MR/W014548/1) to study people living with multiple long-term conditions (MLTC). GEMINI focuses on elucidating shared mechanisms of disease progression to improve patient outcomes. We aim to combine genetic and epidemiological approaches with large-scale data to understand the risks and health outcomes of developing specific pairs of long-term conditions (LTC). We hypothesise that unrecognised combinations of conditions arise due to shared biological pathways and that these can be discovered and characterised using combined epidemiological and genetic approaches.
The CPRD analysis aims to investigate shared risk factors associated with commonly co-occurring conditions with shared genetic heritability and the impact of specific co-existing LTCs on mortality, hospitalisation, and disability. Other health outcomes will be informed by our workshops with patients with lived experience of the conditions as well as by clinicians.
In CPRD AURUM, we will investigate the most prevalent co-existing conditions using logistic regression for a cross-sectional analysis of LTC pairs in those over 65. We will investigate the progression of groups of individuals with pairs of LTCs from pre-diagnosis to death, analysing risk factors for onset and clinical prognosis. We will investigate longitudinal health outcomes, co-developed in PPIE and clinician workshops, in individuals over 40 for the most prevalent LTC pairs. We will use binomial conditional logistic regression to define risk factors common to both conditions and Fine and Gray survival analysis to investigate the effect of having both conditions on outcomes, including mortality and hospitalisation.
Overall, GEMINI will expand knowledge on common combinations of causally related LTCs, defining shared targets and mechanisms for improved therapeutic management. Knowledge of causally related conditions will point to new pathways and paradigms of care, potentially reducing polypharmacy and informing personalised treatment approaches.
Source -
Impact of SSRI and (or) SNRI antidepressant use on cardiovascular health in adult patients with a diagnosis of anxiety disorder: a retrospective cohort study — Judith Brouillette ...
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Impact of SSRI and (or) SNRI antidepressant use on cardiovascular health in adult patients with a diagnosis of anxiety disorder: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-30
Organisations:
Judith Brouillette - Chief Investigator - Montreal Heart Institute
Samuel Cyr - Corresponding Applicant - Montreal Heart Institute
Christel Renoux - Collaborator - McGill University
Marie-Claude Guertin - Collaborator - Montreal Heart Institute
Michelle Samuel - Collaborator - Montreal Heart Institute
Paul Khairy - Collaborator - Montreal Heart Institute
Rafik Tadros - Collaborator - Montreal Heart InstituteOutcomes:
All-cause cardiac mortality; Myocardial infarction; Stroke; Ventricular tachycardia; All-cause mortality
Description: Lay Summary
Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) are medications offered to treat a variety of anxiety disorders. Some studies found a link between SSRI/SNRI use and increased risks of abnormal heart rhythm and death. But stopping those treatments, or reducing their dose, doesnât weigh mental health benefits for the patient against potential heart risks.
The aim of this study is to better understand the relationship between SSRI/SNRI use and the risk for heart health. We will focus on the risks of heart attack, stroke, heart rhythm modifications, and death. We will also look at whether taking multiple SSRI(s)/SNRI(s) is linked to a greater risk of heart issues.
To do so, we will use data from the Clinical Practice Research Datalink (CPRD). We will analyse anonymized electronic medical records from general practices and hospitals, and anonymized death records, of adult patients who received a diagnosis for an anxiety disorder. A group of patients taking SSRI(s) and/or SNRI(s) will be compared to another group of patients not taking those medications. We will then compare the amount of recorded heart issues and deaths between the two groups. Our analyses will also include known risk factors such as sex, age, smoking and other health conditions.
This study will provide further information whether there is a link between SSRI/SNRI use and risks of heart issues and death. This will provide important information to physicians and patients for the management of anxiety disorders using medications.
Technical SummarySelective serotonin reuptake inhibitor/selective serotonin and norepinephrine reuptake inhibitor (SSRI/SNRI) use has been associated with serious cardiac adverse events, including lethal ventricular arrhythmia torsades de pointes. Further research is needed to address SSRI/SNRI cardiac safety. Our study will investigate the impact of SSRI/SNRI use in patients with an anxiety disorder on cardiovascular mortality, myocardial infarction, stroke, ventricular tachycardia and total mortality, controlling for relevant confounding. Patients exposed to SSRI/SNRI will be compared to non-exposed patients.
Our retrospective cohort study will include at least 10,000 adults who received an anxiety disorder diagnosis between 1st January 2010 and 31st December 2010. Outcomes will be recorded up until 31st December 2019. Linked CPRD primary care data, Hospital Episode Statistics data (HES), and Office for National Statistics (ONS) Death Registration data will be analyzed.
The outcomes will be myocardial infarction, stroke, ventricular tachycardia, all-cause cardiac mortality, and total mortality. ICD-9 and ICD-10 codes will be used to identify diagnoses in HES and primary care datasets, while mortality data will be retrieved from the ONS dataset.
Confounding factors such as demographic characteristics, smoking, comorbidities and use of other drugs, will be accounted for. Baseline characteristics and the incidence of cardiac comorbidities and deaths will be summarised. The relative risk of all study outcomes will be estimated with the hazard ratio (HR) from Cox proportional hazards regression models, with SSRI/SNRI use as a time-dependent covariate. HRs will be adjusted for confounders.
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Prescription of cardiovascular disease prevention in primary care: a cohort study — Emily Herrett ...
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Prescription of cardiovascular disease prevention in primary care: a cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-24
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The outcomes will be prescription of:
⢠blood pressure lowering medications, and
⢠lipid lowering medications
in 12 months following a risk assessment. The primary outcome will be prescription in the 6-12 months following risk assessment.Description: Lay Summary
The UK has well established guidelines for recommending statins and blood pressure lowering drugs to patients to reduce the risk of heart attacks and strokes. Statins are recommended to patients who are at high risk of heart attacks and strokes. Blood pressure lowering drugs are recommended based on both a patientâs blood pressure and their risk of heart attacks and strokes. GPs use the guideline recommendations, their own judgement, and discussions with the patient to decide on treatment. For example, when considering whether to prescribe blood pressure drugs, GPs will take into account not only the broad national guidelines but also (i) the risk of reducing blood pressure too much, which may lead to dizziness and falls, (ii) the risk of kidney disease, heart failure and stroke if a patient is not treated, and (iii) patient choice. Therefore, there are likely to be differences in the ways that the same patient would be treated across different GPs within the UK.
Technical Summary
This study aims to determine whether the right patients are receiving treatment and whether there are groups of patients who are not receiving treatment when they should be. Results will be compared to a similar study from New Zealand, where guidelines are the same for statins but different for blood pressure.
Performing comparisons between countries with different guidelines will help us understand whether differences in guidance affect the way statins and blood pressure-lowering drugs are used in practice.Background
The UK has well established guidelines for the management of cardiovascular disease risk factors. Lipid lowering treatment is recommended based on predicted absolute cardiovascular disease risk. Blood pressure lowering treatment is recommended largely on the basis of blood pressure cut-offs.
Each GP is advised to combine guideline recommendations, clinical judgement and shared decision making with the patient to decide upon treatment. Adherence to guidelines therefore depends on a multitude of GP and patient factors.
Aim
The overall aim of this study is to examine the prevalence of prescriptions for blood pressure lowering treatment and lipid lowering treatment, and to identify missed opportunities and inequalities in care.
Methods
Initially, using a cohort of patients registered in a CPRD Aurum practice between 1st January 2011 and 31st December 2019, this study will describe use of blood pressure lowering and lipid lowering medications in the 12 months after a cardiovascular disease risk assessment, stratified by individual cardiovascular disease risk factors and predicted ten year risk of cardiovascular disease. Univariate logistic regression models will be used to determine the crude association of each risk factor with prescriptions. We will investigate whether prescribing is guideline compliant and assess inequalities by age, sex, ethnicity and socioeconomic status, adjusting for age and sex to identify independent effects.
These analyses will determine whether the right patients are receiving treatment. This CPRD study will be compared to similar analyses using data from New Zealand. The UK and New Zealand provide a useful comparison in settings due to their disparate blood pressure but similar lipid lowering guidelines. These analyses will enable us to understand whether GPs tend to use risk to guide treatment decisions, and to what extent differences in guidance influence treatment decisions.
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Trends in General Practice and Emergency Department Use in Children — Mai Stafford ...
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Trends in General Practice and Emergency Department Use in Children
Datasets:GP data, HES Accident and Emergency; Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-16
Organisations:
Mai Stafford - Chief Investigator - The Health Foundation
Yannis Kotrotsios - Corresponding Applicant - The Health Foundation
Andrew Campbell - Collaborator - The Health Foundation
Jay Hughes - Collaborator - The Health FoundationOutcomes:
The primary outcomes of interest are:
GP consultation rates (all-cause) in the 16 and under age group;
ED attendance rates (all-cause) in the 16 and under age groupThe secondary outcomes are:
GP consultation rates in older age groups (aged 17 and over);
GP consultation rates in the under 1s age group;
ED attendance rates in the under 1s age group;
Avoidable ED attendance rates in the 16 and under age group;
ED attendance rates for respiratory conditions in the 16 and under age group;
ED attendance rates for injury in the 16 and under age group;
Discharge destination from the ED coded as admitted or not admitted to in-patient careDescription: Lay Summary
The number of children visiting A&E has been steadily increasing over the last ten years. Whilst the causes of the increase in A&E visits remain unclear, it has been suggested that it may, in part, be due to difficulties in accessing general practice appointments. This study will use information contained in health records to describe these A&E visits for different age groups, ethnic groups, levels of socioeconomic deprivation and diagnoses and calculate how many of these visits might be avoidable. It aims to understand more about the relationship between children's A&E attendances and their access to general practice appointments and explore possibilities to reduce avoidable A&E visits.
Technical SummaryBoth general practice (GP) and hospital services in England are under increasing pressure because of workforce constraints and rising demand. Young children have some of the highest general practice visit rates of any age group and are more frequent users of the emergency department (ED) than adults. In recent years there has been a significant increase in ED attendances among children. This trend may, in part, be driven by growing GP capacity constraints.
This study aims to better understand children's use of the ED and explore possibilities to reduce avoidable ED attendances. Analysis will help us understand which ED attendances could be treated in settings other than acute hospital care. We will use record level data, held in CPRD Aurum, linked to Hospital Episode Statistics to describe the trends in emergency care activity for all children aged 16 years and under and in subgroups of children (based on sex, age group, ethnicity and socioeconomic deprivation level). We will describe GP consultation rates in children between April 2013 and March 2020. Using time series regression, we will also model the association between these trends.
We will also describe trends in GP consultations rates in adults and older people (age groups 17 years and over) to understand how GP activity has changed across age groups in recent years.
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Exploring the standard of care among Very High Fracture Risk patients using Real World Data from Clinical Practice Research Datalink (CPRD) with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) Death Registration — Joshua Warden ...
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Exploring the standard of care among Very High Fracture Risk patients using Real World Data from Clinical Practice Research Datalink (CPRD) with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) Death Registration
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-05
Organisations:
Joshua Warden - Chief Investigator - UCB Biopharma SRL - Belgium Headquarters
Adam Jedrzejczyk - Corresponding Applicant - UCB Pharma Ltd
Alireza Moayyeri - Collaborator - UCB CelltechOutcomes:
Primary outcome:
- Summary statistics of characteristics of interest
- Percentage of patients on treatment, as well as stratified by treatment type and specific drugs
- Time to treatment from osteoporosis diagnosis or fracture events (KM plots)
- Treatment sequence by drug type (Sankey plots)
Secondary outcome(s):
- Percentages of patients on treatment (and Type) stratified by time periods of pre and post Osteoporosis guidelines
- Time to treatment from osteoporosis diagnosis or fracture events by time periods (KM plots)
- Treatment sequence by drug type by time periods (Sankey plots)Description: Lay Summary
Currently osteoporosis which causes weakening of the bone, is a growing issue with osteoporosis causing a large burden on patients as well as healthcare services and is currently underdiagnosed and undertreated. There is a particular burden in patients that are deemed as very high fracture risk (VHFR), meaning they are likely to experience a fracture soon. Osteoporosis medication has been shown to maintain or strengthen bone and to reduce the risk of fractures, however due to undertreatment patients are missing the benefit of this treatment.
Technical Summary
This study will use anonymous GP and hospital records with the aims to describe the level of care in patients that are classed as VHFR, such as those with history of fracture, diagnosed with osteoporosis or test results that indicate low bone density. It will be carried out in women 50 or over in England between 2010 and 2022.The study will investigate VHFR patient characteristics and the number of VHFR patientâs that received and didnât receive treatment as well as the type of osteoporosis treatment they received. We will also look at how long it takes from when the patient is classified as VHFR to the date they received osteoporosis medication. Lastly, we will investigate if there is any change over time from when osteoporosis guidelines were published. Findings from this study will be used to draw attention to the undertreatment of patients resulting in better standard of care having a consequential impact of lower burden and improving quality of life.This will be a retrospective cohort study based in England from 1st January 2010 to 31st December 2022, with the aim of identifying the proportion of female patients aged 50 ⥠classified as VHFR that received bone targeting treatments as well as treatment patterns. The study will use data from CPRD Aurum as well as linkage to Hospital Episode Statistics (HES) for patients primary and secondary care to access patients treatment pathways such a medication received and to capture hospital events such as fractures and clinical diagnosis. Study index will be the date that patients are first classified as being a VHFR patient with definition based on literature and National Osteoporosis Guideline Group (NOGG) guidelines. Patients will be recruited from January 2012 to allow for a 2-year lookback period for baseline variables and to December 2021 to allow at least 1 year follow up. Patients will be followed up till either end of study period, death or end of data availability whichever occurs first. Treatment patterns will also be investigated by reporting the usage of bone forming vs antiresorptive and time from VHFR classification to treatment using KM plots as well as the use of Sankey plots to portray treatment switching. Subgroup analysis of patients classified as VHFR pre- and post-introduction of NOGG guidelines will also be carried out. The findings from this study will be used to highlight treatment gaps with the aim of improving treatment uptake and reducing burden of disease.
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Cardiovascular mortality and morbidity in patients with chronic obstructive pulmonary disease, obstructive sleep apnoea and the overlap syndrome: a matched cohort study — John Hurst ...
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Cardiovascular mortality and morbidity in patients with chronic obstructive pulmonary disease, obstructive sleep apnoea and the overlap syndrome: a matched cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-10-10
Organisations:
John Hurst - Chief Investigator - University College London ( UCL )
Amar Shah - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Chibueze Ogbonnaya - Collaborator - University College London ( UCL )
John Hurst - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Swapna Mandal - Collaborator - Royal Free London NHS Foundation TrustOutcomes:
Our primary outcome of interest is cardiovascular mortality. Deaths will be identified using the International Classification of Diseases 10th edition (ICD-10) codes from the UK Office for National Statistics.
Our key secondary outcomes include all-cause mortality; incident acute coronary syndrome; incident stroke; and incident heart failure.
Description: Lay Summary
This project involves looking at two common lung conditions. The first is called chronic obstructive pulmonary disease (COPD), which is a condition where there is damage to the lungs, usually from smoking. The second is obstructive sleep apnoea (OSA), a condition where patientsâ stop breathing in their sleep. Both conditions increase the chance of dying from heart disease, having a heart attack and a stroke. Some people have both conditions (called overlap syndrome). It is not known whether people with overlap syndrome have a higher chance of dying from heart disease compared to people with either condition alone. If they do, we can target treatments in this group of patients earlier, preventing them from getting heart disease and dying in the future. It will also help choose the correct management for this group of patients.
The main idea behind this project is to use electronic health records, specifically GP patient records and hospital records and follow people with COPD, OSA and overlap syndrome over several years. We will then look at how many people in each group die from heart disease, develop a heart attack or stroke, and compare the numbers in each group. This will allow us to find out whether people with overlap syndrome have worse outcomes, and allow doctors and other healthcare workers to prioritise treatment in this group of patients.
Technical SummaryBackground
Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnoea (OSA) are common respiratory conditions each affecting over a million patients in the UK. Between a quarter and one third of people with COPD die secondary to cardiovascular disease and severe OSA is also associated with an increased risk of cardiac death (RR 2.96 (1.45 â 6.01). This increased risk is secondary to a combination of intermittent hypoxia, systemic chronic inflammation and increased oxidative stress. The combined presence in the same individual is known as COPD-OSA overlap syndrome. It is not known whether patients with COPD-OSA overlap syndrome have a higher cardiovascular disease burden compared to either condition alone.Overarching aim/objectives
Utilise electronic health records to determine whether patients with COPD-OSA overlap syndrome have a higher cardiovascular mortality and morbidity compared to COPD or OSA alone.Methods and Data Analysis
This will be a matched cohort study, investigating the following outcomes of interest: cardiovascular mortality; all-cause mortality; incident acute coronary syndrome, incident stroke and incident heart failure. The exposures of interest will be patients with COPD alone, OSA alone and COPD-OSA overlap syndrome. For each participant in the exposure groups, we will use exposure density matching to select controls (1:3), with no prior record of COPD or OSA. The data sources utilised will be the CPRD Aurum database, with linked data from Hospital Episode Statistics admitted patient care and outpatient data and Office for National Statistics mortality data. Cox proportional hazards regression analysis will be used to compare mortality between the exposures.This study will allow targeting of primary preventative strategies in overlap patients that reduce cardiovascular risk and improve outcomes in this population. This has been identified as a key research priority by both the National Institute of Clinical Excellence and the American Thoracic Society.
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ID-372: External validation and update of an asthma exacerbation risk prediction model for adults — Imperial College London...
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ID-372: External validation and update of an asthma exacerbation risk prediction model for adults
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Asthma exacerbation risk prediction model for adults.
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ID-373: St Mary’s HIU Pilot: Evaluation Framework — Imperial College Health Partners...
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ID-373: St Mary’s HIU Pilot: Evaluation Framework
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: HIU pilot evaluation framework.
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ID-371: Impact of social inequalities on incidence and burden of asthma — Imperial College London...
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ID-371: Impact of social inequalities on incidence and burden of asthma
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Impact of social inequalities on asthma.
Source
2023 - 09
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Research Fellows using ADR England flagship datasets — unknown...
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Research Fellows using ADR England flagship datasets
Where: unstated
When: 2023-9-1
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding six Research Fellows for 18 months to conduct research and analysis demonstrating the policy impact potential of ADR England flagship datasets. This was the first fellowship opportunity of its kind by ADR UK that invited applications across the full suite of ADR England flagship datasets.
Two Research Fellows will use the Annual Survey of Hours and Earnings (ASHE) linked to the 2011 Census â England and Wales. This dataset allows for insight into the dynamics of wage and employment issues, and how characteristics such as gender, disability, and ethnicity influence these.
Two Research Fellows will use data from the Department for Educationâs Longitudinal Education Outcomes (LEO) Standard Extract which allows analysis of educational pathways within and after education and longer-term labour market outcomes. It can provide unique insights into the transitions of individuals from education to the workplace.
The Growing Up in England (GUIE) and Grading and Admissions Data for England (GRADE) datasets will form the basis of the remaining two fellowships. The GUIE dataset can be used to better understand how factors such as household circumstances and geography shape educational outcomes for children in England. GRADE allows researchers to evaluate the judgements made in awarding grades in the 2020 Covid-19 pandemic, ensuring that lessons are learned.
All these datasets will be accessed via the Office for National Statistics (ONS) Secure Research Service.
Find out about the Research Fellows and their projects below.
Dr Ezgi Kaya
Source -
ADR Wales themed projects: Major Societal Challenges — unknown...
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ADR Wales themed projects: Major Societal Challenges
Where: unstated
When: 2023-9-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
From the Covid-19 pandemic to climate change and the cost of living, modern society is facing unprecedented challenges - the impacts of which will be felt by generations to come. To address currently identified and new emerging priority areas for government, ADR Wales has created a Major Societal Challenges work stream. This will monitor, evaluate and research the impacts of major societal challenges over time and across generations for the whole population.
Covid-19 will be the initial focus of this work stream, with an early focus on the Pandemic | Administrative Data Research (PAND|AR) project. PAND|AR will focus on the five harms approach, looking closely at both the direct and indirect harms arising from the Covid-19 pandemic on individuals, services and inequalities at a population-scale, and pandemic recovery.
Read more about the projects:
Evaluation of the Covid-19 vaccination rollout programme in Wales, and across the UK
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ADR Wales themed projects: Health and Wellbeing — unknown...
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ADR Wales themed projects: Health and Wellbeing
Where: unstated
When: 2023-9-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The ADR Wales Health and Wellbeing programme brings together health and wellbeing administrative data with novel geospatial data to provide insights into health and wellbeing in Wales.
Led by Professor Ronan Lyons OBE and Associate Professors Richard Fry and Lucy Griffiths, this programme of work will provide insights into the role socio-environmental factors play in the inequalities that exist across Wales and how these impact on the health and wellbeing of the Welsh population.
The research programme aims to provide a robust policy evaluation of The Well-being of Future Generations Act and The Active Travel Wales Act. In support of the Programme for Government, the research team will generate new evidence for these policy areas through collaboration with key stakeholders Public Health Wales, Natural Resources Wales, and Health Data Research UK.
Looking ahead, research will focus on three core areas:
characterisation of Long Covid-19 in the Welsh population and understanding the socio-environmental inequalities which drive it development of models of 24-hour exposures at home, to and from work, and in work, for a range of environmental factors in collaboration with ADR Scotland evaluation of the impacts of the built and natural environment on the health and wellbeing of the Welsh population.Read more about the projects:
Workplace data linkage
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ADR Wales themed projects: Skills and Employability — unknown...
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ADR Wales themed projects: Skills and Employability
Where: unstated
When: 2023-9-22
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Why are some individuals who enter the Welsh labour market already in a disadvantaged position? What interventions can be made to address this disadvantage? These are just some of the questions that will be investigated by the ADR Wales Skills and Employability research programme.
This innovative programme will continue to work with education partners in Wales to better understand the barriers individuals face in finding meaningful work and accessing the skills and training they need. The programme will address questions of low skills levels in Wales, and the progression from education and training to meaningful jobs against a backdrop of Brexit and the pandemic. This research is aligned with Welsh Governmentâs commitment to addressing the effects of these economic shocks while also building âan economy based on the principles of fair work, sustainability and the industries and services of the futureâ.
The research team will follow the pathways from education through to training and employment. The interaction of individuals with services from the government (such as employment and training support programmes) and third-sector agencies (such as Careers Wales) produces a rich resource of administrative data. The research team can use this data to learn about the various socioeconomic and demographic factors that affect employment and labour market outcomes. Linking this data across de-identified education and census datasets can have an even greater impact in producing policy-informing research needed to help break the poverty cycle.
Read more about the projects:
Widening participation in the tertiary education sector in Wales
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ADR Wales themed projects: Climate Change — unknown...
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ADR Wales themed projects: Climate Change
Where: unstated
When: 2023-9-8
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Welsh Government has responded to the climate crisis with several key policies, including Net Zero Wales (2021-2025) and the Well-being of Future Generations (2015) Act, aimed at building a âstronger, greener, fairerâ Wales over the coming decades. Climate policies to reduce our reliance on fossil fuels may pose risks to certain sectors, but also offer an opportunity to advance policies that can transform society for the better. It is crucial that over the next âdecade of actionâ Welsh Government has access to high quality data and evidence that can effectively identify and evaluate these transition risks and opportunities, and ensure funding is prioritised towards the most cost-effective climate solutions.
Projects under this ADR Wales theme will work with Welsh Government and other stakeholders to identify priority areas and harness the potential of de-identified administrative data within SAIL. They will generate evidence that can inform policy and help Wales achieve a fair and inclusive transition to net zero, where all of society and nature can thrive.
The research programme will focus on three pressing issues in Wales:
Health impacts of extreme weather events Climate change transition risks and opportunities Associations between biodiversity, ecosystem resilience and health.The Climate Change research theme is led by Co-Academic Leads, Rich Fry and Lucy Griffiths.
Read more about the projects:
Increasing temperatures and the impact on population health
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ADR Wales themed projects: Mental Health — unknown...
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ADR Wales themed projects: Mental Health
Where: unstated
When: 2023-9-22
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The ADR Wales Mental Health research programme led by Professor Ann John will focus on the issues of anxiety, depression, and suicide and self-harm prevention. This is in line with the Welsh Governmentâs commitment to invest in mental health by redesigning services to âimprove prevention, tackle stigma and promote a no-wrong door approach to mental health supportâ.
While there was already in a rise in mental health-related themes prior to the pandemic, the research team aims to better understand the impacts of the pandemic itself on children and young peopleâs mental health. This analysis is informed by the teamâs previous research on school absences and exclusions and their connections to mental health diagnoses. Ultimately, it is hoped that providing an evidence base can lead to policies and practices focused on identifying and treating poor mental health as early as possible, before a crisis point is reached.
The Mental Health research programme has strong links to a number of leading mental health organisations and steering groups. Ann John is Principal Investigator and Co-Director of DATAMIND, The Health Data Research Hub for Mental Health. She also leads the Adolescent Mental Health Data Platform, the Suicide Information Database-Cymru, the informatics work streams of the Wolfson Centre for Young Peopleâs Mental Health, and the National Centre for Mental Health. She is affiliated with numerous other mental health organisations.
Read more about the projects:
Impact of antidepressant prescribing guidance
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ADR Wales themed projects: Housing and Homelessness — unknown...
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ADR Wales themed projects: Housing and Homelessness
Where: unstated
When: 2023-9-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
How do we make a Wales where homelessness is rare, brief and unrepeated? This important question drives ADR Wales research under this thematic area. It will explore opportunities for more timely interventions, and produce an evidence base on what works to prevent homelessness, for whom, and in what context.
A large part of this work will be to collaborate with the homelessness policy team in Welsh Government and the wider housing-support related sector in Wales. This aims to improve local authority homelessness data collection and to deposit historic data in the SAIL Databank to facilitate linkage-based research.
Working alongside peers from the Centre for Homelessness Impact, the UK Collaborative Centre for Housing Evidence (CaCHE) and the Wales Institute of Social and Economic Research and Data (WISERD), as well as Welsh Government policy teams, ensures that this research will have greater relevance and impact on the work of the housing-related sector in Wales and the wider UK.
Read more about the projects:
Housing pathways of young people in the UK
Source -
ADR Wales themed projects: Climate Change — unknown...
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ADR Wales themed projects: Climate Change
Where: unstated
When: 2023-9-8
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Welsh Government has responded to the climate crisis with several key policies, including Net Zero Wales (2021-2025) and the Well-being of Future Generations (2015) Act, aimed at building a âstronger, greener, fairerâ Wales over the coming decades. Climate policies to reduce our reliance on fossil fuels may pose risks to certain sectors, but also offer an opportunity to advance policies that can transform society for the better. It is crucial that over the next âdecade of actionâ Welsh Government has access to high quality data and evidence that can effectively identify and evaluate these transition risks and opportunities, and ensure funding is prioritised towards the most cost-effective climate solutions.
Projects under this ADR Wales theme will work with Welsh Government and other stakeholders to identify priority areas and harness the potential of de-identified administrative data within SAIL. They will generate evidence that can inform policy and help Wales achieve a fair and inclusive transition to net zero, where all of society and nature can thrive.
The research programme will focus on three pressing issues in Wales:
Health impacts of extreme weather events Climate change transition risks and opportunities Associations between biodiversity, ecosystem resilience and health.The Climate Change research theme is led by Co-Academic Leads, Rich Fry and Lucy Griffiths.
Read more about the projects:
Increasing temperatures and the impact on population health
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ADR Wales themed projects: Early Years — unknown...
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ADR Wales themed projects: Early Years
Where: unstated
When: 2023-9-8
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Combining expertise from backgrounds in early years, child health, mental health and education to name just a few, the ADR Wales Early Years research team brings together this knowledge to deliver well-rounded policy-informing research. This is needed to help all children - particularly those from deprived backgrounds.
Working alongside colleagues from child-focused research programmes including the HAPPEN (Health and Attainment of Pupils in a Primary Education) primary school network, Born in Wales, Health Data Research UK (HDR UK) and the Schools for Health in Europe Foundation (SHE), our work looks at adverse childhood experiences (ACEs). The team aims to inform policy and practice that can best support young people at risk of poor outcomes. Our Early Years portfolio includes:
the analysis of the outcomes for children born of low birth weight or preterm low school readiness the impact of ACEs including domestic violence, living with someone with mental health or substance abuse problems outcomes for children taken into care.Work is also underway to assess whether initiatives and services such as the Welsh Governmentâs flagship Flying Start programme and other initiatives around childcare funding and services for looked after children are increasing the opportunities for young children from disadvantaged backgrounds.
The academic lead for the ADR Wales Early Years programme is Professor Sinead Brophy.
Read more about the projects:
Early years support for children at risk of poor outcomes
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ADR Wales themed projects: Education — unknown...
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ADR Wales themed projects: Education
Where: unstated
When: 2023-9-8
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The ADR Wales Education research programme has been developed in line with the Welsh Governmentâs ambition to deliver a long-term programme of education reform and ensure educational inequalities narrow and standards rise. This is furthered by the commitment that no pupil is âleft behindâ after the Covid-19 pandemic.
The ADR Wales programme for work in this area is supported by the Wales Institute of Social and Economic Research and Data (WISERD) Education Data Lab. This was established in March 2019 to deliver independent analysis of administrative education data to inform national debate on some of the most contemporary and pressing educational issues facing Wales.
With a particular focus on mainstream, compulsory education, the ADR Wales Education programme provides policymakers with the insights to make best placed decisions that support the education sector in Wales and the young people that it serves.
The academic lead for the ADR Wales Education programme is Professor Chris Taylor.
Read more about the projects:
Gender differences in teacher pay and progression
Source - and 41 more projects — click to show
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ADR Wales themed projects: Social Justice — unknown...
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ADR Wales themed projects: Social Justice
Where: unstated
When: 2023-9-22
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This ADR Wales research agenda will cover inequalities in health outcomes, treatment, accessibility to services, opportunities, and education for the population of Wales. It will utilise linked anonymised, individual-level, population-scale data that is routinely collected. This includes demographic, health, environmental, administrative and social data held in the Secure Anonymised Information Linkage (SAIL) Databank. It will define personal characteristics and categorise social groups to ensure marginalised people are represented in the research, to reduce inequalities and unfairness.
The research areas for this theme are:
Research into the current descriptions and characteristics of the population of Wales Research into the interrelation and inequalities between socio-economic, ethnic and marginalised groups and health outcomes Research into major societal challenges in Wales and the impact on vulnerable and marginalised individuals Using data to evaluate, inform and refine interventions and care to tackle health inequity Using data to inform and refine accessibility and equity to services and opportunities Surveillance of violence against minority ethnic groups, people from the LGBTQIA+ community, women and individuals at risk of poor outcomes.Read more about the projects:
Inequalities in career progression
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Estimating Respiratory Syncytial Virus (RSV) burden in adults +50 years in the UK using Real-World Data: a database and time-series modelling study — Catrina Richards ...
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Estimating Respiratory Syncytial Virus (RSV) burden in adults +50 years in the UK using Real-World Data: a database and time-series modelling study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-05
Organisations:
Catrina Richards - Chief Investigator - IQVIA Ltd ( UK )
Sonya Patel - Corresponding Applicant - IQVIA Ltd ( UK )
Briana Coles - Collaborator - IQVIA Ltd ( UK )
Fiona Hill - Collaborator - IQVIA Ltd ( UK )
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Lorena Cirneanu - Collaborator - IQVIA Ltd ( UK )
Saskia Hagenaars - Collaborator - IQVIA Ltd ( UK )Outcomes:
Age at index date; gender at index date; Index of Multiple Deprivation (IMD) at index date; vaccination status for influenza in the 12 months prior to index date; type of RTI; diagnosis of COVID-19 at index date; comorbidities; High-risk status;
RTI-associated hospital admissions; RTI-associated inpatient hospitalisations; RTI-associated mortality (including all mortality and in hospital mortality);
Length of hospital stay; ICU admission; ventilation support; RTI-related re-admissions; all cause re-admissions; respiratory A&E visits; respiratory outpatient consultations; costs of inpatient hospitalisations; costs of ICU admissions; costs of outpatient consultations; costs of A&E visits; total HCRU costs;
RTI-associated primary care consultation within 30 days of RTI-associated hospital admission; RTI-associated hospital admission within 30 days of RTI-associated primary care consultation;
RTI-associated primary care consultations; RTI-associated mortality â primary care;
Cardiorespiratory-associated hospital admission; cardiorespiratory-associated deaths (cardiorespiratory-associated mortality); cardiorespiratory-associated deaths (cardiorespiratory-associated in hospital mortality); cardiorespiratory-associated primary care consultations; cardiorespiratory-associated mortality â primary care;
Description: Lay Summary
Respiratory syncytial virus (RSV) is a common virus that causes acute infections of the lungs and respiratory tract, leading to a substantial burden on healthcare systems worldwide. It affects both young children and older adults, especially those with chronic diseases or weakened immune systems. However, we donât have a clear picture of the impact of RSV on adults aged 60 or older.
Technical Summary
An RSV vaccine candidate (Arexvy) to protect adults aged â¥60 years from severe RSV infections was approved for use in Europe in June 2023. To make informed decisions on vaccines and preventative measures, we need to better understand how RSV affects older adults and how it impacts healthcare resources.
Therefore, this study explores data collected on RSV in older adults (aged â¥50 years) over an 8-year study period (2012 to 2020) in the UK in both primary and secondary care. The study population of adults aged 50 years or older aligns with the potential for future label extension of the vaccine. The study will estimate hospital admissions, primary care visits, and deaths due to respiratory infections, respiratory tract infection (RTI) and flu, and describe healthcare resource usage and costs related to respiratory infections, RSV and flu.
By analysing this data, we can make better decisions about how to prevent RSV infections in older adults, improving public health in the future.We aim to conduct a retrospective cohort study using primary care records (Clinical Practice Research Datalink (CPRD)) linked with secondary care data (Hospital Episode Statistics (HES)) in England for adults 50 years and older with an RTI-related hospital admission or primary care consultation. The study period will be from 01 July 2012 to 30 September 2020.
The study describes patientsâ demographics and clinical characteristics and estimates the number and rate of RTI-associated hospital admissions and mortality, healthcare resource use (HCRU) and associated costs, the patient pathway and the number and rate of RTI-associated primary care consultations and mortality.
Patient characteristics of interest are age, gender, socioeconomic status based on Index of Multiple Deprivation (IMD), vaccination status for influenza, COVID-19 diagnosis, type of RTI (upper [URTI]/lower [LRTI]), comorbidities (chronic respiratory conditions, cardiac disorders, chronic kidney disease, chronic liver disease, diabetes, stroke, immunocompromised diseases) and high-risk status. Mortality variables of interest will include all mortality, in hospital mortality and primary care mortality. HCRU variables of interest are inpatient hospitalisations, length of hospital stay, intensive care unit (ICU) admissions, ventilation support, re-admissions, A&E visits, outpatient consultations and primary care consultations. Associated HCRU costs will be calculated for inpatient hospitalisations, ICU admission, A&E visits and outpatient consultations, using NHS reference tariffs. The admissions or consultations attributable to each pathogen of interest (RSV, influenza or COVID-19) will be estimated using time-series modelling where the weekly number of hospital admissions/primary care consultations for an RTI are regressed on the weekly number of hospital admissions/primary care consultations specified as being caused by the pathogen of interest.
This study will provide a deeper understanding of the burden of RSV in older adults to help generate awareness and inform decision-making on preventative measures, including use in cost-effectiveness modelling of RSV vaccines.
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A case-control study of dementia in people taking three commonly prescribed medications: rizatriptan, beclometasone and allopurinol — Gareth Williams ...
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A case-control study of dementia in people taking three commonly prescribed medications: rizatriptan, beclometasone and allopurinol
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-11
Organisations:
Gareth Williams - Chief Investigator - King's College London (KCL)
Gareth Williams - Corresponding Applicant - King's College London (KCL)
clive Ballard - Collaborator - University of Exeter
Richard Killick - Collaborator - King's College London (KCL)Outcomes:
The main outcome measure of the study is dementia diagnosis. Dementia diagnosis will be according to the Read medical codes.
Description: Lay Summary
As our population ages, an increasing number of people are becoming debilitated through failing memory and decision-making, with over 100 million being affected world-wide by the middle of this century. Apart from the personal impact on individuals, this puts a huge strain on the UK healthcare system, costing £1.7 billion annually. Unfortunately, extensive efforts to develop new drugs have so far failed and increasingly scientists have turned their attention to existing drugs that were developed for other conditions and testing them for their potential benefits in people experiencing problems with memory and decision-making. This approach is promising because it allows for faster progress since the safety of the drugs is already known. In recent tests on individuals aged 50 and older, our research group found that certain medications consistently improve performance in a panel of mental skills tasks. To determine if these drugs truly benefit people with memory and decision-making difficulties, we would like to know whether people on these medications are less likely to develop these problems. By analyzing prescription data, we will be able to answer this important question. It is expected that drugs showing a clear association with a decreased incidence in memory and decision-making problems can be readily prescribed for people showing mild symptoms of the condition, with the hope of slowing down disease progression.
Technical SummaryOur analysis of the the cognitive trajectories in the over 50s through the PROTECT[1] study showed that some medications are associated with favourable cognition profiles. This proposal aims to see whether these benefits are present in a wider cohort through an analysis of prescription data available on the CPRD platform. Our hypothesis is that candidate drug use is associated with a decreased incidence of dementia. To test the hypothesis we propose carrying out a case-control study comparing candidate drug prescription histories of those with dementia relative to those without. Cases will be individuals with a dementia diagnosis between 2012 and 2022. The control cohort will be randomly sampled from those with no dementia and matched for sex, GP practice and age in a 4:1 ratio. The prescription history of the candidate drugs will be assessed prior to the index date defined as the first dementia diagnosis date for the case and matched controls. The three distinct drug sets to be assayed are detailed in the Specific Aims section below. Positive outcomes from this retrospective investigation will enable us to apply for funding to conduct a trial in patients using online monitoring of cognition through our PROTECT platform (30,000 participants with 10% cognitively impaired). We envisage conducting such a trail rapidly and cost effectively given that the candidates have established safety profiles, adopting the protocol developed for our current VitaMIND trial of vitamin D (www.protectstudy.org.uk). Dementia therapy is an urgent unmet need, with UK cases predicted to exceed 1.6 million by 2050. Our investigation has the potential to fast track safe drugs for the symptomatic relief of dementia.
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Demographic characteristics of a population with obesity, atherosclerotic cardiovascular disease, and no diabetes — Marie Michelsen ...
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Demographic characteristics of a population with obesity, atherosclerotic cardiovascular disease, and no diabetes
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-27
Organisations:
Marie Michelsen - Chief Investigator - Novo Nordisk A/S
Tina Landsvig Berentzen - Corresponding Applicant - Novo Nordisk A/S
Lise Lotte Nystrup Husemoen - Collaborator - Novo Nordisk A/S
Mads Jeppe Tarp-Johansen - Collaborator - Novo Nordisk A/SOutcomes:
The five outcomes for the basic demographic description are age; gender; body mass index; race; ethnicity.
Details on the outcome variables are listed in the Section âExposures, Outcomes and Covariatesâ.
Description: Lay Summary
Obesity increases the risk of heart disease, and new treatments for people with obesity and heart disease are developed in clinical trials. Physicians find it hard to use the treatments developed in clinical trials, because they are concerned about whether the trial participants differ from their own patients. If there are big differences, the new treatments may not work safely in their patients.
We will therefore study if a population with obesity and heart disease as defined in a clinical trial reflect patients in general practice in England. To do this, we will use data from the AURUM Clinical Practice Research Datalink (CPRD). In these data, we will define a population from a set of often used trial criteria, and describe age, gender, ethnicity, race, and body mass index in the population.
Hopefully, the study may guide physicians about whether treatments developed in clinical trials are relevant to their broad patient population.
Technical SummaryObesity is associated with a wide range of cardiovascular (CV) risk factors, and obesity increases the risk of CV morbidity and mortality. Several clinical trials have therefore evaluated the CV benefit of different interventions in people with obesity and CV disease (CVD). Currently, there is a strong need to apply interventions to people with obesity and CV disease, but physicians often find it challenging to apply the lessons from clinical trials to their patients. Strict eligibility criteria in clinical trials may exclude relevant participants, and the trial population may not include groups representing large fractions of those who the physician see as candidates for treatment.
We will therefore use a set of commonly used trial eligibility criteria to extract a population with obesity and atherosclerotic CVD (ASCVD) from a large population of patients seen in general practice in England. In this population, we will describe basic demographic characteristics.
The objective of the study is to describe a middle-aged population with obesity, ASCVD and no diabetes according to gender, age, ethnicity, race, and body mass index (BMI).
The study is an observational, cross-sectional study of patients aged at least 45 years with obesity (BMI â¥27 kg/m2), ASCVD (ischemic heart disease, cerebrovascular disease, peripheral arterial disease), and no type 1 or type 2 diabetes registered in the AURUM Clinical Practice Research Datalink (CPRD). These patients will be characterised according to ethnicity and race derived from registrations in the Hospital Episodes Statistics (HES) and according to gender, age and BMI registered in CPRD AURUM at index date.
Hopefully this study may guide clinicians about whether interventions developed in a strictly defined clinical trial setting are relevant to their broader patient populations.
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Long-term real-world effectiveness of glucagon-like peptide-1 receptor agonists compared to dipeptidyl peptidase 4 inhibitors on clinical liver events among individuals with T2D living in England: a longitudinal cohort study — Katrine Grau ...
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Long-term real-world effectiveness of glucagon-like peptide-1 receptor agonists compared to dipeptidyl peptidase 4 inhibitors on clinical liver events among individuals with T2D living in England: a longitudinal cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-14
Organisations:
Katrine Grau - Chief Investigator - Novo Nordisk A/S
Pernille Cromhout - Corresponding Applicant - Novo Nordisk A/S
Jens Tarp - Collaborator - Novo Nordisk A/S
Kamal Kant Mangla - Collaborator - Novo Nordisk A/S
Kamlesh Khunti - Collaborator - University of Leicester
Kevin Tan - Collaborator - Novo Nordisk A/S
Mads Jeppe Tarp-Johansen - Collaborator - Novo Nordisk A/S
Mette Skalshøi Kjær - Collaborator - Novo Nordisk A/S
Quentin Anstee - Collaborator - Newcastle University
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk A/SOutcomes:
The primary outcome of the study is a composite endpoint for which the components are listed below. Events in the outcome are defined as ICD10 or OPCS4 codes from Hospital Episodes Statistics (HES) Outpatient data, HES Admitted Patient Care Data or Office for National Statistics (ONS) Death Registration Data.
PRIMARY ENDPOINT
Clinical liver events (composite endpoint) - using the time to first report of any of the below events captured in HES or ONS:⢠Liver mortality
⢠Hospital contact for liver cirrhosis
⢠Hospital contact for hepatocellular carcinoma (HCC)
⢠Hospital contact for chronic liver failure
⢠Hospital contact for liver transplantation
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⢠Hospital contact for portal hypertension
⢠Hospital contact for gastro-oesophageal varices (of any grade) or portal-hypertensive gastropathy without bleeding
⢠Hospital contact for hepatic decompensation events
o Ascites
o Placement of Trans jugular intrahepatic portal shunt
o Hepatorenal syndrome
o Hepatic encephalopathy
o Jaundice (related to liver-cirrhosis)
o Gastro-oesophageal varices (or portal-hypertensive gastropathy) with bleedingPOTENTIAL SECONDARY ENDPOINTS
When analysing a composite endpoint, there is a risk of one (of the less severe) component driving the entire association. There is also a risk that the composite endpoint masks different types of effect of the intervention. To explore if this is the case, several secondary endpoints will be considered, including specific liver events and a modified version of the composite endpoint.
To get a better understanding of how the choice of outcome affect the study results one or more of the following modified endpoints may be analysed:
1) Hospital contact for hepatic decompensation events
o Ascites
o Trans jugular intrahepatic portal shunt
o Hepatorenal syndrome
o Hepatic encephalopathy
o gastro-oesophageal varices with bleeding
2) Hospital contact for hepatocellular carcinoma (HCC)
3) Composite endpoint (without the most frequent, first occurring event)The primary composite endpoint will be reanalysed after removing the most frequently occurring component. This is expected to be ascites but will be determined from the actual data.
In addition, it will be considered to analyse:
4) All-cause mortality in a subgroup of patients with likely NASH
In this subgroup all-cause mortality is more likely to be affected by potential liver effects of the exposure than would be the case for the entire study population of patients with diabetes.Description: Lay Summary
Fatty liver disease is a public problem affecting many people around the World. For some people a fatty liver causes no problem. But for others it develops into non-alcoholic steatohepatitis, called NASH. NASH is a serious type of fatty liver disease. If NASH gets worse, it can lead to liver complications, such as liver failure and liver cancer.
There is no medicine to treat NASH, but a medicine called GLP-1 used for type 2 diabetes might work. Type 2 diabetes is a common disease where the blood sugar is too high.
With this study we will explore if type 2 diabetes treatment with GLP-1 leads to fewer patients having liver complications. To do this we will use data from nearly 1,500,000 patients with type 2 diabetes examined by their general practitioner in the United Kingdom (CPRD database). We will follow these patients from the first time they get treatment with GLP-1 and calculate how many develop liver failure or die. We will get the information on liver disease and death from hospital and death records.
We hope this study could help us understand if patients treated with GLP-1 are less likely to develop liver complications. If so, this large group of patients with NASH, who right now do not have any treatment options, will be able to get help and thereby avoid liver complications.
Technical SummaryTo date, there is no approved pharmacotherapy for either Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH). Previous research has established an association between type 2 diabetes (T2D) and NAFLD. The widely used glucose-lowering drugs glucagon-like peptide-1 (GLP-1s) agonists have shown promising results by reducing the progression of NASH in patients with T2D. However, there is limited real-world evidence regarding long-term effect of GLP-1 agonists on liver-related outcomes. We propose to study the real-world comparative effectiveness of GLP-1 agonists vs. dipeptidyl peptidase 4 (DPP4) inhibitors on clinical liver events.
Specific aim is to:
Assess the long term, comparative real-world effectiveness on clinical liver events of GLP-1 agonists vs. DPP4 inhibitors in patients with T2D living in England.For this study we use a longitudinal, new user, active comparator cohort design, where individuals newly prescribed GLP-1 agonists (index drug) and individuals newly prescribed DPP-4 inhibitors (comparator drug), are followed for the health outcome(s) of interest. Adults (â¥18 years) with T2D, and a first ever prescription (index date) of GLP-1 agonists or DPP4 inhibitors registered (in CPRD) from 01 January 2007 (the year the first incretin-based drugs entered the UK market) are included in the study population. Patients with registration (in the Hospital Episodes Statistics; HES) of alcohol-related disorders, chronic liver diseases other than NAFLD and/or prescriptions of drugs inducing liver disease (in CPRD) are excluded. Index date equals date of first prescription of GLP-1 agonists or DPP-4 inhibitors with no prescription of either prior to index date.
Individuals are followed from date of inclusion until time of first event recorded in HES or Office for National Statistics Death Registration (ONS), migration from the databases or end of follow-up, whichever comes first. Sensitivity analyses addressing T2D, alcohol, obesity, age, calendar period, deprivation, event type and reverse causality will be conducted.
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Characterisation and treatment pathways of heavy menstrual bleeding using the Clinical Practice Research Datalink: a descriptive study — Siir Su Saydam ...
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Characterisation and treatment pathways of heavy menstrual bleeding using the Clinical Practice Research Datalink: a descriptive study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-28
Organisations:
Siir Su Saydam - Chief Investigator - Bayer AG
Siir Su Saydam - Corresponding Applicant - Bayer AG
Cecile Janssenswillen - Collaborator - Bayer AG
GEORGIOS ARGYRIOU - Collaborator - Bayer AGOutcomes:
Baseline demographics and clinical characteristics of women with HMB diagnosis; Treatment patterns for HMB: prevalence of treatment exposures, treatment pathways and sequencing, time to discontinuation of treatment; Incidence proportion and incidence rate of HMB diagnosis
Description: Lay Summary
Heavy menstrual bleeding (HMB) is characterised by excessive blood loss in menstruation and can have a negative impact on a womanâs quality of life by resulting in bleeding-related accidents, withdrawal from social activities, breathlessness, and fatigue. It is estimated that about one out of every three women of reproductive age seeks medical assistance for HMB. A wide range of treatment options are available for HMB in the UK, while the National Institute for Health and Care Excellence has published a guidance to help healthcare professionals investigate the cause of HMB and offer recommended treatments by taking women's priorities and preferences into account. In severe cases of HMB, when invasive treatment may be required (including removal of the uterus), a woman's fertility can be impaired. However, despite the availability of non-invasive therapeutic options, many women affected by HMB are untreated as women may not recognise their bleeding as abnormal and/or treatable, and healthcare providers may struggle with diagnosis and management. Large real-world population-based studies are not available to quantify and comprehensively characterise women with HMB by age at diagnosis, underlying conditions associated with HMB, other cooccurring diseases and treatment use. The objective of this study is to describe how often HMB is diagnosed in women of reproductive age and how it is treated in clinical practice in several EU countries, the UK and the US. The results will inform on the reporting and clinical management of HMB, which in turn would enable better disease understanding, healthcare management and treatment for patients.
Technical SummaryThis study aims to characterise women of reproductive age diagnosed with HMB in multiple real-world secondary data sources. The objectives of this multinational, observational, retrospective cohort study are to describe baseline demographics and clinical characteristics of women diagnosed with HMB and to describe treatment utilisation for HMB. This will be conducted across a network of data sources standardised to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), including CPRD GOLD and Aurum in the UK. The concept for this study originated from a study proposal awarded by the European Health Data and Evidence Network (EHDEN) and it is an extension of a previously approved study using CPRD. In this currently proposed study, the study design is simplified for the purpose of extending it to EHDEN data partners. More specifically, selection criteria are refined to reflect a more representative HMB population for the target cohort and the objectives related to selected treatments are removed to demonstrate more generalisable treatment pathways. The study population will include women with a first-ever diagnosis of HMB (index event) aged 11 to 55 years. Demographics and clinical characteristics prior to index event will be summarized descriptively. Treatment pathways will be described after index to demonstrate added treatments and/or switches and time to discontinuation of treatment will be calculated using the Kaplan-Meier methodology. Incidence of HMB diagnosis will be reported with respect to the at-risk patient population during the study timeframe. HMB has a great impact on the quality of life of women of reproductive age, while there is limited data from real-world practices to demonstrate under-diagnosis and under-treatment. This study will characterise the patient population with regards to underlying symptoms of HMB and comorbidities to quantify the burden and describe treatments as observed in clinical practice to demonstrate the potential need for better intervention.
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An estimation of the direct healthcare resource use associated with geographic atrophy: a retrospective cohort study in England — Jennifer Davidson ...
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An estimation of the direct healthcare resource use associated with geographic atrophy: a retrospective cohort study in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-01
Organisations:
Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Caoimhe Rice - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hannah Brewer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
James Baird - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Mico Hamlyn - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
Annualised length of stay; Annualised number of hospitalisations; Annualised number of outpatient appointments; Annualised number of A&E attendances; Annualised number of primary care consultations; Annualised cost of hospitalisations; Annualised cost of outpatient appointments; Annualised cost of A&E attendances; Annualised cost of primary care consultations; Number, proportion and incidence of falls or fractures; Number, proportion and incidence of burns or scalds; Number, proportion and incidence of mental health complications; Annualised number of mental health-related primary care referrals; Annualised cost of mental health-related primary care referrals (number and cost); Number and proportion of patients discharged to residential or nursing home; Number, proportion and incidence of deaths;
Description: Lay Summary
Geographic atrophy (GA) is a chronic eye disease that leads to vision loss. People with GA will experience difficulties performing everyday tasks such as reading and driving. Over time, as vision loss gets worse more tasks will become difficult for people with GA, and the risk of events such as falls and trips or burns can increase. Vision loss and subsequent changes to everyday living can adversely affect the mental health and wellbeing of people with GA.
There is limited research on the occurrence of falls and trips, burns, or mental health complications in people with GA, or the healthcare burden due to these events. We will use anonymous data from GP and hospital records from England to describe these events and their healthcare cost in people with GA compared to people who do not have GA.
The results of our study will increase the understanding of the clinical and economic consequences experienced due to GA and should help guide methods to support patients and prevent complications people with GA might experience.
Technical SummaryGeographic atrophy (GA) is an advanced stage of dry age-related macular degeneration (dAMD). While vision loss occurs progressively as dAMD advances, GA is characterised by irreversible central vision loss. As vision loss progresses, individuals with GA experience difficulties in daily activities which can be mentally and emotionally challenging. Vision loss increases the risk of accidental injury such as burns and scalds, or trips and falls which can lead to fractures.
In this retrospective cohort study, we will use linked data from the Clinical Practice Research Datalink, Hospital Episode Statistics, and Office for National Statistics death registrations, to quantify the healthcare resource use (HCRU) and associated cost of GA. We will estimate the all-cause primary and secondary care activity and describe annualised results, using descriptive statistics including means and medians, among patients with GA and matched controls. Similarly, we will describe activity specific to falls or fractures, burns or scalds, and mental health complications. We will then use multivariable generalised linear models with gamma family and log link to compare the annualised all-cause, falls or fractures, burns or scalds, and mental health complications costs in patients with GA to matched controls. To contextualise our findings, we will also describe the incidence of falls or fractures, burns or scalds, and mental health complications among patients with GA and matched controls, and use multivariable Poisson regression to estimate incidence rate ratios for the events. Finally, we will use multivariable Cox proportional hazard regression to compare death in patients with GA to matched controls.
The results generated from this study will quantify the effect GA has on falls or fractures, burns or scalds, and mental health complications as well as the associated healthcare burden, thereby highlighting where support and prevention strategies for GA patients may be best focused.
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Dental patient encounters in general medical practices: a real-world evidence study — Jianhua Wu ...
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Dental patient encounters in general medical practices: a real-world evidence study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-14
Organisations:
Jianhua Wu - Chief Investigator - Queen Mary University of London
Harriet Larvin - Corresponding Applicant - Queen Mary University of London
Vanessa Muirhead - Collaborator - Queen Mary University of LondonOutcomes:
Primary outcome: dental patient encounters in primary care.
Secondary outcome: hospitalisation; disease diagnoses and secondary care referrals.Description: Lay Summary
As dental services buckle under the stresses of understaffing and long waitlists, people are having difficulty receiving the dental advice and treatment they need. Since the COVID-19 pandemic these struggles have deepened; it is suspected that people are looking to other healthcare services including general practitioner (GP) appointments as a way of finding help.
Technical Summary
While GPs can prescribe medication for pain relief and provide general health advice, they do not have the means or equipment to treat complicated dental problems in their practices. As a result, the efficiency of primary care services themselves are becoming even more strained. The effects on primary care for dental patient encounters is not clear in the UK.
This research project will use primary care medical records to determine the impact of dental encounters in primary care. Using statistical methods, we will explore the trends in time and geography to understand healthcare burden of GP dental patient encounters. We will also study patient information such as age, gender, and region, as well as their medical history to understand the patient groups who are seeking dental care from their GP services.
Not only will this inform healthcare providers on the burden, the results of this study could also guide future policy as evidence for better integration of primary medical and dental services.It has been well-reported that in recent times dental services have struggled with understaffing and long waitlists. As such, patients are having difficulty receiving the dental advice and treatment they need. The COVID-19 pandemic has exacerbated this issue; with patients looking to other healthcare services including general practitioner (GP) appointments for their dental problems.
In primary care, patients with dental complaints may receive general advice and/or prescriptions of antibiotics or pain relief, however these are not long-term solutions and often the dental problem can worsen. Certain patient groups may be more likely to attend primary care with dental complaints due to limited access to dental appointments. With the growing evidence for links between oral-systemic diseases, dental encounters in primary care may indicate symptoms of uncontrolled chronic disease.
As yet there has been no largescale population-based study that provides high-resolution insights into the healthcare burden of dental patient encounters in primary care in the UK.
Specifically, the study will:
1. Describe the temporal trends, prescribing and geographic variations in the incidence of dental encounters that patients present with at GP practices.
2. Examine the impact of COVID-19 on GP dental consultations
3. Assess associations between GP dental consultations and sociodemographic, clinical (patient-level) and practice characteristics.
4. Quantify the incidence of hospitalisation following dental patient encounters in primary care.
Quantifying the population trends of GP dental patient encounters will reveal the healthcare burden of this issue. Linkage of deprivation data will reveal associations between GP dental consultations and sociodemographic and practice characteristics. Demonstrating subsequent hospitalisation and development of co-morbidities via examination of linked secondary care data (HES) could also reveal more about oral-systemic disease trajectories. The expected impact of this work is to inform strategies for better integration of primary medical and dental services at a crucial time in healthcare reform.
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Linaclotide Safety Study for the Assessment of Diarrhoea Complications and Associated Risk Factors in the UK population with Irritable Bowel Syndrome predominantly with constipation (IBS-C) — Javier Cid ...
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Linaclotide Safety Study for the Assessment of Diarrhoea Complications and Associated Risk Factors in the UK population with Irritable Bowel Syndrome predominantly with constipation (IBS-C)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; CPRD Aurum Pregnancy Register; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-20
Organisations:
Javier Cid - Chief Investigator - Evidera Ltd - UK
Javier Cid - Corresponding Applicant - Evidera Ltd - UK
Ahunna Ukah - Collaborator - AbbVie Inc. USA (Headquarters)
Hai Nguyen - Collaborator - Evidera Ltd - UK
Mai Duong - Collaborator - Evidera Ltd - UK
Robert Donaldson - Collaborator - Evidera Ltd - UK
Sonia Halhol - Collaborator - Evidera Ltd - UKOutcomes:
SCD is the main outcome of interest and will be defined as diarrhoea (as documented by diagnostic codes) and subsequently (between the diarrhoea diagnosis date and 45 days afterwards) any of the following outcomes:
â Dehydration that requires intravenous rehydration
â Dehydration that requires oral rehydration with solutions of electrolytes
â Electrolyte imbalance: potassium (serum potassium levels 3.0â3.5 mEq/L or <3.0 mEq/L) and sodium (serum sodium levels >150 mEq/L)
â Oliguria (urine output < 400 mL in 24 h)
â Anuria (urine output < 50 mL in 24 h)
â New-onset thromboembolism episodes
â New-onset orthostatic hypotension
â New-onset syncope
â New-onset dizziness
â New-onset vertigo
â Acute renal failure
â Hypovolemic shock
â Hospitalisation due to diarrhoea
â Stupor
â Coma
â Death
Read and Systematized Nomenclature of Medicine [SNOMED] codes used to identify these conditions are provided in Appendix II. The definition will be validated through a GP questionnaire to estimate the positive predictive value of this definition.Description: Lay Summary
Irritable bowel syndrome (IBS) is a condition that affects the digestive system. IBS can cause a range of symptoms such as cramps, bloating, diarrhoea and constipation. These symptoms come and go and can last from days to months at a time. IBS is very common. In the United Kingdom between one in ten and one in five people are estimated to suffer from IBS, mainly women between the age of 20 and 30. People with IBS have different symptoms, some patients mainly experience diarrhoea, some constipation (IBS-C) and other patients alternate between the two. Traditional treatment of patients with IBS-C include lifestyle and diet improvements, and medications such as laxatives.
Linaclotide is the first medication to be approved in the European Union for the treatment of patients with moderate to severe IBS-C. Although linaclotide is effective in relieving constipation symptoms it may cause diarrhoea. This study, requested by the European Medicines Agency, aims to describe how often patients taking linaclotide develop severe complications of diarrhoea. It also aims to investigate which patients are most likely to suffer from such complications. The results of this study are expected to inform physicians and improve how they treat patients with IBS-C.
Technical SummaryIrritable bowel syndrome (IBS) is a chronic, relapsing gastrointestinal condition characterised by abdominal pain, bloating, and changes in bowel habits. Prevalence estimations vary with the diagnostic criteria used, and in the United Kingdom (UK) were estimated between 9.5% and 22% with more recent estimates using Rome IV criteria ranging between 4% (95% CI: 3.1-4.8%) and 4.6% (95% CI: 3.7-5.5%). IBS can be classified according to Rome IV criteria into four subtypes, based on stool form, as IBS predominantly with diarrhea (IBS-D), IBS predominantly with constipation (IBS-C), IBS with mixed bowel habits (IBS-M) and IBS unsubtyped (IBS-U). IBS-U is used only when there is insufficient abnormality of stool consistency to meet the criteria for any of the other above subtypes.
Linaclotide (Constella®), a guanylate cyclase-C receptor agonist with visceral analgesic and secretory activities, was approved as the first medicine authorised for the symptomatic treatment of moderate-to-severe IBS-C in adults in the European Union (EU), and as a condition for approval the EMA requested a post-authorisation safety study to assess the risk of diarrhoeal complications in patients taking linaclotide.
This study plans to investigate the risk of developing severe complications of diarrhoea (SCD) during treatment with linaclotide among patients with IBS-C in the UK and to investigate what the risk factors for experiencing SCD are.
CPRD GOLD, CPRD Aurum, Hospital Episode Statistics, and Office for National Statistics data will be used.
This study is a retrospective case-control study nested in a cohort of patients with IBS-C, with validation of potential cases of SCD. Descriptive statistics and Cox proportional hazards regression will be used.
The results of this study are expected to inform physicians and improve how they treat patients with IBS-C, aiming to prevent potential SCD experienced by these patients.
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Inequalities in unplanned hospital admission and the role of continuity of care. — Anne Alarilla ...
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Inequalities in unplanned hospital admission and the role of continuity of care.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-01
Organisations:
Anne Alarilla - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Anna Powell - Collaborator - The Health Foundation
George Stevenson - Collaborator - The Health Foundation
Jay Hughes - Collaborator - The Health Foundation
Mai Stafford - Collaborator - The Health FoundationOutcomes:
Outcomes of interest will be derived from CPRD and linked Hospital Episode Statistics (HES) data.
The primary outcome is all-cause unplanned hospital admissions.
Secondary outcomes are:
⢠unplanned hospital admissions for ambulatory care sensitive conditions
⢠length of stay for all-cause unplanned hospital admissions
⢠length of stay for ambulatory care sensitive conditions
⢠visits to the Accident and Emergency Department
Description: Lay Summary
Having an unplanned hospital admission can be an unpleasant experience and is sometimes avoidable. The number of people experiencing unplanned hospital admission is increasing and the chance of an unplanned admission is higher for certain groups. For example, people living in socioeconomically deprived circumstances have a higher chance of experiencing an unplanned hospital admission and are more likely to spend longer in hospital.
There may be factors within primary care that can help reduce unplanned admissions. Seeing the same general practitioner (GP) over time allows the relationship between patient and GP to develop. This is known as continuity of care. Patients with higher continuity of care have fewer unplanned admissions, lower mortality rate and overall report better patient experience. This may be particularly helpful for people with complex health needs such as those managing multiple long-term conditions, or people juggling complex social needs such as those living in socially deprived areas. We know that people living in areas of deprivation tend to have more difficulty seeing a GP (in part because there are fewer available GPs) and they have lower continuity of care.
This study uses health care records to understand if there are inequalities in experiencing an unplanned hospital admission, and whether low continuity of care helps explains these inequalities. This will show whether more resources to improve continuity of care are needed in certain kinds of areas. This could help healthcare leads to target resources and ultimately contribute to avoiding some unplanned hospital admissions in more deprived areas.
Technical SummaryUnplanned hospital admissions have increased in the last 10 years and certain groups are at higher risk of these admissions, such as people with multiple long-term conditions and people experiencing socioeconomic deprivation. Low continuity of care in primary care is also associated with higher risk of unplanned hospital admissions. Improving continuity overall and in specific groups may contribute to avoiding unplanned admissions and reducing inequalities in unplanned admissions.
This study uses a random sample of adults from CPRD to: describe both continuity of care and unplanned hospital care across levels of deprivation; describe the association between continuity of care and unplanned hospital care; and examine whether continuity of care helps explain inequalities in risk of unplanned hospital care.
This information will be used to increase our understanding of the value of continuity of care for patients and for use of healthcare, and to advocate for resources to improve continuity.
This observational follow up study uses CPRD data from 2017-2018, linked Index of Multiple Deprivation (IMD) data, and linked Hospital Episode Statistics from 2019 (Admitted Patient Care and Accident and Emergency).
Risk of unplanned hospital admissions (all-cause and for ambulatory care sensitive conditions), length of unplanned hospital admission (all-cause and ambulatory care sensitive conditions), and risk of accident and emergency visit will be estimated using a series of multilevel linear and logistic regression models. Models will be sequentially adjusted for i) sex, age, total number of consultations and length of follow up, ii) IMD decile, and iii) number of long-term conditions. We will also explore the possible mediating influence of continuity of care on inequalities in unplanned hospital care. All models will include random effects to allow for clustering at practice level.
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"Cancer prevention, screening, diagnosis and prognosis in people with learning disabilities — Darren Ashcroft ...
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"Cancer prevention, screening, diagnosis and prognosis in people with learning disabilities
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-15
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Oliver Kennedy - Corresponding Applicant - University of Manchester
Alex Trafford - Collaborator - University of Manchester
Alison Wright - Collaborator - University of Manchester
Louise Gorman - Collaborator - University of Manchester
Paul Lorigan - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of Manchester
Umesh Chauhan - Collaborator - University Of Central LancashireOutcomes:
Cancer incidence (for any cancer and the 20 commonest primary cancers); place of first presentation, overall survival; cancer specific survival; 1-year survival; 5-year survival; 10-year survival; HPV vaccination, cervical cancer screening performed; positive cervical cancer screening test result; cervical cancer following positive screening result; breast cancer screening performed; positive breast cancer screening test result; breast cancer diagnosis following positive screening result; bowel cancer screening performed; positive bowel cancer screening test result; bowel cancer diagnosis following positive screening test result; PSA test performed; positive (i.e. abnormal) prostate specific antigen test result; prostate cancer following positive (i.e. abnormal) prostate specific antigen test result; recording of QCancer and QCancer-10y risk scores; predicted risk of current and future cancer by QCancer and QCancer-10y risk scores; predicted risk of current and future cancer by random forest model; observed current and future cancer risk.
Description: Lay Summary
In England, males and females with learning disabilities die more than a decade earlier than their counterparts in the general public. Among people with learning disabilities, cancer is the third leading cause of death (excluding COVID-19). It is unclear whether individuals with learning disabilities are more or less likely to develop cancer due to genetic or lifestyle factors. It has previously been shown that people with learning disabilities are less likely to participate in national cancer screening programmes, which aim to detect cancer early, increasing the chances for successful treatment. People with learning disabilities may also be less likely to consult their doctors about cancer symptoms until the disease has advanced, which could reduce treatment options and life expectancy.
This research project aims to explore the numbers of new cases of cancer each year in individuals with learning disabilities and their life expectancy following diagnosis. It also aims to explore uptake of vaccination against human papillomavirus (HPV), which causes several cancers. It will measure use of cancer screening tests and timeliness of cancer diagnoses. To investigate possible inequalities, we will make comparisons between those with and without learning disabilities, taking into account other important factors, such as age, sex, ethnicity and deprivation. We will conduct this study using a large dataset of general practice, hospital and death records in order to include a large number of people. This study will enhance our understanding of the impact of cancer on people with learning disabilities and help guide future healthcare strategies.
Technical SummaryLife expectancies of males and females with learning disabilities are, respectively, 14 and 17 years lower than the general population. Cancer in this group is a leading cause of death but has not been well-studied. Differences may exist in exposure to cancer risk factors, use of cancer prevention measures (e.g. HPV vaccination) and use of cancer risk assessments (e.g. QCancer). Screening uptake may be lower and there may be inequalities in accessing diagnostic procedures and treatments.
This study will use CPRD Aurum, Hospital Episode Statistics (HES) and Office of National Statistics (ONS) mortality data to investigate cancer diagnoses and survival among individuals with learning disabilities. Incidence rates will be estimated for cancer overall and the 20 commonest UK cancers. Incidence rate ratios will be estimated using Poisson regression and survival using Kaplan-Meier and Cox regression. Cancer screening participation (i.e. for breast, colorectal, and cervical cancer, and prostate specific antigen [PSA] testing) will be assessed along with screening incidence rate ratios, relative risks of test positivity and times to diagnoses.
Emergency presentations of cancer will be examined by comparing dates of diagnoses in primary and secondary care records. Participation in the national HPV vaccination program will also be evaluated. The use and accuracy of primary care cancer risk assessment tools, particularly QCancer and QCancer-10yr, will be investigated using measures of calibration and discrimination. Random forest modelling, which has been used previously with CPRD data for risk prediction, will be assessed for its cancer risk prediction accuracy in this group.
This study has the potential to inform targeted interventions and healthcare strategies to address disparities in cancer incidence, survival, and screening among people with learning disabilities. Insights will enable stakeholders to develop and implement evidence-based approaches to improve cancer-related outcomes in this population.
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To examine the recording of surgical treatments for rectal prolapse in secondary care and explore definitions for establishing establishing the use of surgical mesh: a linked CPRD and HES data feasibility study. — Katherine Donegan ...
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To examine the recording of surgical treatments for rectal prolapse in secondary care and explore definitions for establishing establishing the use of surgical mesh: a linked CPRD and HES data feasibility study.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-05
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Jenny Wong - Corresponding Applicant - MHRA
Helen Booth - Collaborator - CPRDOutcomes:
In HES data, the following outcomes will be measured during the study period: rectal prolapse; intussusception; vaginal prolapse; abdominal rectopexy with and without surgical mesh; other abdominal operations for prolapse of rectum; and perineal operations for prolapse of rectum; surgical treatments for vaginal prolapse.
The following outcome measurements would be calculated from the HES-APC data:
â¢The number of patients with their first surgical procedure for rectal prolapse identified during the study period. This will be the study cohort. Use of codes that indicate use of mesh will be explored within the cohort.
â¢The proportion of the study cohort who had a ICD-10 diagnostic code for rectal prolapse or intussusception recorded, with an event date in the 12 months prior to or on the same date as their index date.
â¢The number of patients within the study cohort who had a ICD-10 diagnostic code for vaginal prolapse or a OPCS-4 code for a surgical procedure to treat vaginal prolapse procedure recorded in the 12 months prior to or on the same date as their index date.
â¢The frequency of recurrence of a rectal prolapse operation code recorded during the study period after the study patientâs index date.
â¢The frequency counts of other OPCS-4 codes recorded with the same event date as the date recorded against the OPCS-4 code for a rectal prolapse operation in the HES-APC data.
Based on the above outcome measures listed above, an algorithm for identifying procedures using mesh and the type of mesh used would be developed.Description: Lay Summary
Rectal prolapse occurs when the wall of the rectum becomes weakened and passes down through the anus. It is a disabling condition and can result in serious complications that negatively impact a patientâs quality of life. It may cause constipation, incontinence, pain and discomfort, and discharge of mucus or blood from the rectum.
Technical Summary
There are conservative and surgical treatments for this condition. Non-surgical treatments focus on managing symptoms and reducing the prolapse. In individuals with significant rectal prolapse, they may require surgical treatment. Rectopexy is one surgical method which involves fixation of the bowel to support its position, prevent further prolapse and improve function. This procedure can be performed with or without the use of a surgical mesh to fixate the bowel. The MHRA is undertaking a review into the use of surgical mesh in rectopexy procedures. This review runs alongside the ongoing monitoring of the use of surgical mesh for treating stress urinary incontinence and prolapse of other organs in the pelvis. Serious adverse complications had been reported in some patients who had undergone such procedures using surgical mesh. These safety concerns with surgical mesh were also considered as a case study in The Independent Medicines and Medical Devices Safety Review (IMMDS).
This study aims to improve our understanding of the recording of surgery for rectal prolapse, including use of surgical mesh, to better define variables in future studies to investigate postoperative complications associated with mesh rectopexy procedures. These studies may be conducted in CPRD and other healthcare databases.The MHRA are currently undertaking a review of rectopexy procedures using surgical mesh to treat rectal prolapse. Rectopexy involves the fixation of the rectum to support the position of the anatomy, to minimise further prolapse and improve functionality. The fixation can be performed with and without the use of surgical mesh. During the Independent Medicines and Medical Devices Safety Review (IMMDS) review, it highlighted concerns in identifying the use of mesh in surgical procedures treating stress urinary incontinence and uro-gynaecological prolapse, and therefore the difficulty in quantifying the size of population at risk. These concerns remain valid for identifying the use of mesh in rectopexy procedures.
The study will explore the recording of rectopexy and the alternative procedures in secondary care data. The population who had a rectopexy performed using fixation with and without mesh during the study period would be estimated. The population who had an alternative surgical procedure to treat rectal prolapse would also be estimated.
This study will use CPRD Aurum data with linked Hospital Episode Statistics Admitted Patient Care (HES-APC) data set. It will aim to quantify the number of surgical procedures performed for rectal prolapse between April 2011-March 2021, by patient age, gender, the type of procedure and by mesh usage. The study will measure within the study population, the number of patients who had a record indicative for rectal prolapse and those who had a diagnosis of vaginal prolapse or a surgical treatment for vaginal prolapse, as rectal prolapse can be secondary to vaginal prolapse.
The findings of this study will be used to support the development of a case definition for establishing rectopexy procedures using mesh in secondary care data. It will also aid in the planning of safety monitoring activities, including epidemiological studies to explore post-operative complications associated with rectopexy procedures.
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Predictors of discontinuation or reduction of long-term opioid therapy and its associated adverse events in patients with chronic non-cancer pain in the UK primary care: a retrospective cohort study — Evangelos Kontopantelis ...
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Predictors of discontinuation or reduction of long-term opioid therapy and its associated adverse events in patients with chronic non-cancer pain in the UK primary care: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-28
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Qian Cai - Corresponding Applicant - University of Manchester
Charlotte Morris - Collaborator - University of Manchester
Christos Grigoroglou - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Douglas Steinke - Collaborator - University of Manchester
Li-Chia Chen - Collaborator - University of Manchester
Louise Gorman - Collaborator - University of Manchester
Thomas Allen - Collaborator - University of ManchesterOutcomes:
The following outcomes will be measured for each individual work package:
1. Work package 1- the primary outcomes are patterns of opioid utilisation and the prevalence of long-term opioid therapy (LTOT). Patterns of opioid utilisation include:
⢠Opioid characteristics, stratified by potency (strong vs weak), formulation (immediate release vs modified release), and duration (long-term vs no).
⢠Mean or median daily dosage (will be converted into oral morphine equivalent dose [OMEQ] based on the conversion factors (1), and trichotomised as low [<50 mg OMEQ] vs medium [50-120 mg OMEQ] vs high [>120 mg OMEQ])
⢠Median annual days covered (will be calculated from the sum of days that each person was covered by any opioid within a given patient-year)
⢠Concomitant medication utilisation (benzodiazepines, gabapentinoids, antidepressants, Z-drugs, antipsychotics and muscle relaxants, defined as a filled prescription at any time during the long-term opioid use or in the 7 days before it begins)
⢠Time to the initiation of opioids post CNCP diagnosis.Currently this is no consensus on the definition of LTOT. Therefore, we propose a definition for LTOT based on existing literature (25). The suggested definition is receiving three or more opioid prescriptions over a period of 90 days or longer in any consecutive 180-day period, with no 28-day gap between fill dates. However, it is important to acknowledge that this definition remains subject to potential revision based on the analysis of opioid utilisation patterns derived from the datasets. Therefore, we will explore potential alternative definitions that may become available, or we may devise our own after examining the data.
2. Work package 2 - we will examine two co-primary outcomes:
⢠The discontinuation of LTOT.
⢠The reduction of LTOT.
(Specific definitions of these two outcomes are provided in section L. Briefly, the discontinuation of LTOT is defined as the absence of any opioid prescription claims for at 180 days following any period after a continuous LTOT period of 90 days or more. The reduction of LTOT is defined as a â¥â10% reduction in average OMEQ compared with the baseline dose, in both of two consecutive 90-day periods during the follow-up period.)
Secondary outcomes of interest include:
⢠Time to the first treatment changes (i.e., LTOT discontinuation or reduction) after the initiation of opioids.
⢠The proportion of patients re-initiated opioid use after the first treatment break (i.e., LTOT discontinuation) and the time from it to the re-initiation of opioids.3. Work package 3 - we will examine two co-primary outcomes:
⢠Bone fractures following the first discontinuation/reduction of LTOT.
⢠Opioid related death following the first discontinuation/reduction of LTOT.Description: Lay Summary
In recent years, there has been a significant increase in the use of opioids (potent painkillers) for chronic pain. However, this has raised concerns of potential harmful effects associated with its long-term use, such as dependence, addiction, bone fractures, and death. In response to this, national healthcare organisations in the United Kingdom (UK) have released guidelines, advocating healthcare providers to consider reducing or stopping long-term opioid therapy when benefits are minimal and outweighed by potential harms.
To help healthcare providers make informed decisions, we need to find out how patients reduced or stopped their long-term opioid use, and what factors influence these actions. We also want to explore any potential risks that may arise following these recommendations. Such information will help healthcare providers to figure out target patients, for whom discontinuation/reduction of long-term opioid therapy is likely and beneficial.
Using UK primary care data, hospitalisation record, and national death information from the Clinical Practice Research Datalink, we will focus on how opioids are used in patients with chronic pain. In particular, whether patients discontinued or reduced their long-term opioid therapy. We will then investigate various factors that trigger these prescribing changes. Additionally, we will use statistical methods to compare the occurrence of negative consequences in this group of patients with those who continued their long-term opioid treatment.
The findings of this research will provide evidence to guide safer prescribing practices for opioids, inform the development of strategies to minimise potential harms of long-term opioid therapy, and ultimately enhance patient safety.
Technical SummaryThe increased use of opioids for chronic non-cancer pain (CNCP) in the UK raises serious risks, such as addiction, respiratory depression, bone fractures, and drug-related death. Recent UK NICE guidelines advocate for reducing or discontinuing opioid use when significant harms are present. To guide practice, we aim to assess factors influencing the reduction or discontinuation of long-term opioid therapy (LTOT) and compare risks of serious adverse events associated with these actions among patients with CNCP in England.
This study comprises three work packages (WP). WP1 is a drug utilisation study that will use data from CPRD Aurum from 1 March 2000 to 31 March 2021. The cohort includes CNCP patients who received â¥1 prescription for opioids in their entire record. Patients will be followed from the initiation of opioid therapy until they transfer out of their GP practice, experience death, or reach the end of study period, whichever occurs first, to identify opioid prescribing patterns and the prevalence of LTOT. WP2 is a nested case-control study that will use CNCP patients classified as long-term opioid users from WP1 and group them as discontinued/reduced LTOT vs. continued LTOT. Predictors of these two treatment changes will be analysed using mixed-effects logistic regression models. WP3 will use data from CPRD linked with HES and ONS registry to assess the incidence of bone fractures and opioid-related death in patients discontinued/reduced LTOT vs. those continued LTOT. We will use a 1:1 (or 1: N) propensity score matching method to match the samples. Then, we will use marginal structural Cox regression with inverse probability of treatment weighting, adjusting for covariates, to determine associations between LTOT discontinuation/reduction and the time to events. The proportional hazards assumption will be evaluated by plotting Schoenfeld residuals. We will also use parametric survival models as alternative analytical approaches.
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Care interventions in the development of heart failure and frailty and their impact on outcomes: a cohort study — Umesh Kadam ...
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Care interventions in the development of heart failure and frailty and their impact on outcomes: a cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-08
Organisations:
Umesh Kadam - Chief Investigator - University of Exeter
Umesh Kadam - Corresponding Applicant - University of Exeter
Ke Li - Collaborator - University of Exeter
Krasimira Tsaneva-Atanasova - Collaborator - University of Exeter
Sarah Bailey - Collaborator - University of ExeterOutcomes:
(i) Heart failure; frailty
(ii) planned and unplanned hospital admissions
(iii) all-cause-mortality and HF-specific mortalityDescription: Lay Summary
Heart Failure is a condition, often of the older person, that is characterised by multiple problems and high levels of healthcare in the community and hospitals. High disease and treatment burden to patients are indicators and risks for the development of 'frailty'. Frailty refers to a personâs mental and physical resilience, or their ability to bounce back and recover from events like illness and injury. Heart failure is common in older people and is often associated with deterioration in health and recovery over time. The key challenge for the NHS is whether care delivery focuses on the heart failure or in fact care delivery adopts a more holistic model that includes how frail the person is, to improve overall health.
Using the CPRD databases, we will first look at how patterns of conditions and care influences how heart failure develops, and how these change after diagnosis. Second, we will look at how heart failure and frailty develop together and impact on subsequent hospital admissions and death. Third, we will develop models that help predict which patients with heart failure and frailty are more at risk of hospital admissions and death. These findings will provide the evidence for the NHS and policy makers to bring together the management of heart failure and frailty in better ways to shift away from looking at a person as just with the disease to thinking more of the person's health as a whole when they are older.
Technical SummaryBackground: It is known that Heart Failure (HF) is associated with poor prognosis for emergency hospital admissions and death, and it is also one of the key conditions that associated with the development of frailty. Data-driven approaches have been used to define frailty in health care records, and frailty without a fixed disease context, is associated with poor outcomes in older populations. However, it is unknown how HF and frailty develops and how the combination of HF and frailty influences real-world healthcare and clinical outcomes.
Design: Historical cohort studies
Methods: In the populations aged 40 years and over, the CPRD Gold and Aurum datasets will be used to identify an incident HF cohort and compared to a cardiovascular cohort without HF and a randomly age and gender matched cohort. The outcomes data will be ascertained from primary care data linked to Hospital Episode Statistics (HES) and ONS death data. In three phases, using longitudinal mixed models, flexible parametric models and machine learning methods to investigate trajectories, time-dependent effects on outcomes and predictive models. There will be an investigation of patient (age, gender, socioeconomic status, ethnicity), clinical (comorbid conditions and severity), care factors (multiple medications use, routine tests [physiological markers, devices and imaging], contact patterns), and how they relate to the development of HF and frailty and the subsequent prognosis of the outcomes of hospital admissions and death.
Outcomes: This investigation will determine the key patient, clinical and care factors that contribute to development of HF, and frailty before and after the diagnosis of new HF and the impact on unplanned admissions and death in HF patients. HF and frailty are major NHS and public health policies and investigating the relationship between HF and frailty provides potential new opportunities for earlier interventions to improve the care of the older populations.
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An observational study program to investigate the management and consequences of hyperkalemia in cardiorenal patients in routine clinical practice — Eva Lesen ...
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An observational study program to investigate the management and consequences of hyperkalemia in cardiorenal patients in routine clinical practice
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-22
Organisations:
Eva Lesen - Chief Investigator - AstraZeneca AB (Sweden)
Jil Billy Mamza - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Christen Gray - Collaborator - AstraZeneca Ltd - UK Headquarters
Clement Erhard - Collaborator - AstraZeneca Ltd - UK Headquarters
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Meg Parbrook - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
⢠Patient characteristics and treatment patterns
⢠Cardiorenal healthcare resource use associated with reduced RAASi treatment
Pending feasibility
⢠Characteristics and treatment patterns in SZC initiators
⢠Odds of maintained RAASi in SZC relative to No potassium binder cohorts
⢠Odds of emergency department visits or hospitalisations with HK in SZC relative to No potassium binder cohortsDescription: Lay Summary
Hyperkalaemia is caused by elevated potassium levels in the blood and can cause irregular heart rhythms that can affect the normal functioning of the heart and can be life-threatening. Hyperkalaemia is traditionally treated with reducing dietary potassium, withdrawing or reducing exacerbating medications like renin-angiotensin-aldosterone system inhibitor (RAASi) therapy which helps to regulate blood pressure and fluid balance in the body, or by administering potassium binder medications. Although RAASi treatment is a cornerstone of chronic kidney disease and heart failure treatment, it can also cause hyperkalaemia. The current clinical guidelines emphasise the importance of managing hyperkalaemia to facilitate RAASi therapy and recommend potassium binders (oral anti-hyperkalaemia treatment) for this purpose. The choice of conventional potassium binders to use is limited by their adverse effects, palatability, and questionable chronic efficacy, which limits their long-term use. Newer treatment options such as patiromer and sodium zirconium cyclosilicate (SZC), are non-systemic, non-absorbed potassium binders which increase potassium excretion through the intestine and are indicated for hyperkalaemia. It is important to understand how hyperkalaemia is managed nowadays, and how novel potassium binders, like SZC, can keep RAASi stable after a hyperkalaemia episode in routine clinical practice, to improve adherence to treatment guidelines and to optimise patient care. Therefore, this study will use administrative healthcare records to describe patient characteristics and treatment patterns with potassium binders and RAASi therapy in patients with heart and kidney diseases who are experiencing hyperkalaemia, and to describe healthcare resource use in these patients.
Technical SummaryUsing a cohort of patients with diagnostic clinical assessment for hyperkalaemia (HK), we aim to describe patient characteristics and treatment patterns with potassium binders and RAASi therapy in patients with cardiorenal disease (i.e. chronic kidney disease and/or heart failure) who experience an HK episode. We will describe the healthcare resource use associated with reduced RAASi treatment following an HK episode in cardiorenal patients. This study will utilise both CPRD Aurum and Gold database with linkage to Hospital Episode Statistics (HES) admitted patient records and the study period will begin on 1 January 2018 until the last GPâs collection day. Patient characteristics and health care resource use will be described for the study population and the results will be summarised using descriptive statistics.
In addition, propensity score matching or weighting will be applied to balance the cohort who reduced RAASi treatment to the cohort who maintained their RAASi treatment. In these PS-matched or weighted cohorts, patient characteristics and treatment patterns with potassium binders and RAASi therapy will be described using descriptive statistics, and cardiorenal health care resource use will be described using incidence rates and all-events rates per 100 person-years, and cumulative incidence via the Kaplan-Meier method. The association between reduced RAASi treatment and cardiorenal health care resource use will be assessed using Cox proportional hazards regression models. Such evidence will be used to highlight any unmet treatment needs and inform the evidence gap in this area.
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Association of sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists with the risk of developing dementia in people with type 2 diabetes — Krishnarajah Nirantharakumar ...
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Association of sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists with the risk of developing dementia in people with type 2 diabetes
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-06
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Jingya Wang - Corresponding Applicant - University of Birmingham
Konstantinos Toulis - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of BirminghamOutcomes:
The primary outcome is all-cause dementia. The secondary outcomes are the two main subtypes of dementia, Alzheimerâs disease and vascular dementia. Outcome events have to occur after the onset of diabetes. Individuals with a record of target outcome event in each cohort will be excluded from analyses.
Description: Lay Summary
It is estimated that the number of individuals affected by dementia, a general term for loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life, worldwide was about 57 million in 2019, which is expected to reach 153 million by 2050. Diabetes, a condition that has trouble regulating the amount of sugar in the blood, has been associated with an approximately 2-fold increase in the relative risk of cognitive decline and dementia later in life, while younger age at the onset of diabetes mellitus, worse glucose control and a history of severe hypoglycaemia (a low blood sugar level) episodes have been reported as contributing factors. It appears that the use of two different glucose-lowering drugs, Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitors and Glucagon-like Peptide-1 (GLP-1) Receptor Agonists, might be associated with a neuroprotective potential in the context of diabetes. If this is confirmed, it might have important clinical and public health implications for everyday practice, considering the prevalence and associated-ramifications of dementia-related disorders. Therefore, we plan to perform a population-based cohort study in CPRD Aurum to compare the risk of all-cause dementia, Alzheimerâs disease, and vascular dementia between (i) SGLT2 inhibitors and (ii) GLP-1 receptor agonists against Dipeptidyl Peptidase IV (DPP-4) inhibitors, another glucose-lowering drug, among people with type 2 diabetes.
Technical SummaryAims:
To investigate whether the use of SGLT2 inhibitors or GLP1 receptor agonists is associated with the risk of dementia, compared to DPP4 inhibitors.Methods:
We will perform two cohort studies using a new-user design to investigate the effects of SGLT2 inhibitors or GLP1 receptor agonists separately. Propensity score fine stratification weighting will be applied to create a pseudo-comparator group with similar characteristics as the exposed group. Competing risk Cox proportional hazard regression models will be used to calculate crude hazard ratios (crude HRs) and adjusted hazard ratios (adjusted HRs), together with their corresponding 95% CIs. Death during the follow-up period will be treated as a competing event.Outcomes:
The primary outcome is all-cause dementia. The secondary outcomes are the two main subtypes of dementia, Alzheimerâs disease and vascular dementia.Exposure and comparator:
SGLT2 inhibitors users will be compared to DPP4 inhibitors users in SGLT2 Cohort, while GLP1 receptor agonists users will be compared to DPP4 inhibitors users in GLP1 Cohort.Participants:
Individuals with a diagnosis of type 2 diabetes aged 40 years and over who received SGLT2, GLP1 receptor agonists, or DPP4 will be eligible for this study. Those with a record of CKD stage 5 will be excluded from this study. All participants must have been registered with the general practice for at least one year before the index date (start of follow-up).Covariates:
Sociodemographic characteristics, behavioural risk factors, diabetes-related characteristics, comorbidities, biomarkers, and drug prescriptions will be adjusted to account for residual confounding.Intended public health benefits:
If the neuroprotective effect of SGLT2 inhibitors and GLP1 agonists is confirmed, it might have important clinical and public health implications for everyday practice, considering the prevalence and associated ramifications of dementia-related disorders. Conversely, it means that all three medicines are safe to prescribe in practice.
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The presence of obstructive sleep apnoea and the risk of cardiovascular disease in individuals with atrial fibrillation — Jingya Wang ...
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The presence of obstructive sleep apnoea and the risk of cardiovascular disease in individuals with atrial fibrillation
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-08
Organisations:
Jingya Wang - Chief Investigator - University of Birmingham
Jingya Wang - Corresponding Applicant - University of Birmingham
G. Neil Thomas - Collaborator - University of Birmingham
Gregory Lip - Collaborator - University of Liverpool
Krishnarajah Nirantharakumar - Collaborator - University of BirminghamOutcomes:
The primary outcome is composite CVD. The secondary outcomes are ischaemic heart disease (IHD), heart failure (HF), and stroke or transient ischaemic attack (stroke/TIA).
Description: Lay Summary
Atrial fibrillation (AF) is a heart condition that causes an irregular and often abnormally fast heart rate, affecting 37 million people worldwide and accounts for about one-third of hospital admission for cardiac rhythm disturbances (irregular heartbeat), and has been linked to an increased risk of cardiovascular diseases (CVD, a general term for conditions affecting the heart or blood vessels). As a common coexisting condition in individuals with AF, obstructive sleep apnoea (OSA is when a blockage in your airway keeps air from moving through your windpipe while you're asleep) shares many common risk factors and consequences with AF. According to the current guidelines, assessment of risk factors and subsequent use of appropriate therapy in individuals with AF is crucial in the prevention of CVD and AF-related complications. However, the limited and often conflicting evidence available, means that it was uncertain if the presence of OSA would further increase the risk of CVD in individuals with AF, implying the need for large population-based studies in this regard. We hypothesise that the presence of OSA may further increase the risk of CVD in individuals with AF. The aim of this study is to investigate the association between OSA and the incidence of CVD in individuals with AF. If this assocaition can be confirmed, given the OSA morbidity in individuals with AF and its potential impact on cardiovascular disease and quality of life, proactive detection and management of OSA in individuals with AF may further support the holistic care of these individuals.
Technical SummaryAim:
To investigate whether the presence of obstructive sleep apnoea (OSA) is associated with the risk of cardiovascular diseases (CVD) in individuals with atrial fibrillation (AF).Method:
Individuals with OSA will be compared with matched individuals without OSA for the risk of developing CVD in later life. Competing risk Cox proportional hazard regression models will be used to calculate crude hazard ratios (crude HRs) and adjusted hazard ratios (adjusted HRs), together with their corresponding 95% CIs. Death during the follow-up period will be treated as a competing event.Outcomes:
The primary outcome is composite CVD. The secondary outcomes are ischaemic heart disease (IHD), heart failure (HF), and stroke or transient ischaemic attack (stroke/TIA).Exposure and comparator:
Individuals with AF and OSA will be compared to those with AF but not OSA.Participants:
Adults aged 18 years and above with a diagnosis of AF and registered between 1st of January 2000 and to 31st of December 2022. All participants must have been registered with the general practice for at least one year before the index date (start of follow-up). For each sub-cohort created for one specific outcome, individuals with a record of the corresponding outcome condition at baseline will be excluded.Covariates:
Sociodemographic characteristics, behavioural risk factors, comorbidities, biomarkers, and medications will be adjusted to account for residual confounding.Intended public health benefit:
If the association of OSA and CVD in individuals with AF can be confirmed, given the OSA morbidity in individuals with AF and its potential impact on cardiovascular disease and quality of life, proactive detection and management of OSA in individuals with AF may further support the holistic care of these individuals.
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Identifying treatable traits of people with asthma prescribed an Inhaled Corticosteroid and Long Acing Beta-2 Agonist (ICS-LABA) - a descriptive analytic study in England — Mohamed Hamouda ...
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Identifying treatable traits of people with asthma prescribed an Inhaled Corticosteroid and Long Acing Beta-2 Agonist (ICS-LABA) - a descriptive analytic study in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-27
Organisations:
Mohamed Hamouda - Chief Investigator - GlaxoSmithKline - UK
Elke Rottier - Corresponding Applicant - Adelphi Real World
Arunangshu Biswas - Collaborator - GSK India Global Service Private Limited
Jennifer Quint - Collaborator - Imperial College London
Lucinda Camidge - Collaborator - Adelphi Real World
Poppy Payne - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Sarah Law - Collaborator - Adelphi Real WorldOutcomes:
Asthma exacerbation; over-reliance on reliever therapy.
Description: Lay Summary
Asthma is a disease which affects the airways of the lungs. Asthma symptoms include coughing, wheezing and shortness of breath. Globally in 2019, there were approximately 262 million people with asthma and the condition caused around 450,000 deaths. Inhaled Corticosteroid / Long Acting Beta-2 Agonist (ICS/LABA) is a medication commonly used by people with asthma to help keep their airways open and prevent symptom flare-ups. People with poorly controlled asthma (e.g. those who experience regular symptoms, broken sleep and interruptions to their daily living) can experience symptom flare-ups and many rely on temporary medication, known as reliever therapy, to ease symptom flare-ups. Poorly controlled asthma is often a result of people taking asthma medications incorrectly or living with other conditions affecting their asthma.
Technical Summary
Symptom flare-ups and reliance on reliever therapy are linked with reduced quality of life, so factors that increase a personâs risk for flare-ups are important to understand. Factors known to increase the risk of poorly controlled asthma include old age, smoking history, depression and other related conditions. However, there is little evidence in England on how these factors interact with each other and increase the chance of symptom flare-ups or reliance on reliever therapy in people prescribed an ICS/LABA. Observing interactions between these factors will provide information on people with similar characteristics which can be used to tailor treatment management for people with asthma in clinical practice.Aim: To understand treatable traits of adults with asthma newly initiating twice daily single inhaler ICS/LABA therapy in England. Exacerbations and over-reliance on reliever therapy are linked with reduced quality of life in asthma, so risk factors are important to understand.
Objectives: To: i) identify baseline socio-demographics and clinical characteristics of adults with asthma that are predictors of exacerbation or over-reliance on reliever therapy after initiating twice daily single inhaler ICS/LABA therapy; ii) describe treatment characteristics following initiation of twice daily single inhaler ICS/LABA therapy among risk groups; and iii) describe socio-demographic, clinical and treatment characteristics of adults with asthma prescribed Seretide® or Symbicort®, respectively.
Methods: Retrospective analysis of longitudinal healthcare data in England utilising linked primary and secondary care data from Clinical Practice Research Datalink (CPRD) Aurum and Hospital Episode Statistics (HES) datasets, respectively.
Index criteria: Asthma diagnosis; twice daily ICS/LABA dual therapy
Covariates: Baseline characteristics (age, gender, region, ethnicity, deprivation, BMI, smoking status, eosinophil levels, comorbidities, Charlson Comorbidity Index (CCI), peak expiratory low rate (PEFR), forced expiratory volume, dyspnea scale score, asthma symptoms, history of asthma-related exacerbation, history of over-reliance on reliever therapy, previous maintenance therapy, previous oral corticosteroid use (OCS use), primary care consultations and hospitalizations) and treatment characteristics (ICS/LABA brand, treatment add-on or switches, duration on treatment, daily average ICS/LABA dose, dose change, ICS/LABA adherence, ICS/LABA frequency, ICS/LABA device type)
Outcomes: Asthma exacerbation; over-reliance on reliever therapy.
Data analysis: People will be classified based on binary outcome status (asthma exacerbation and over-reliance on reliever therapy). Demographics and clinical characteristics will be assessed in relation to outcome status using a supervised learning method. A pragmatic approach will then be used to select most important predictors of outcomes in order to form homogeneous clusters via an unsupervised learning algorithm. Treatment characteristics will be described within each homogeneous cluster.
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Validation of the Birmingham Lung Improvement Studies (BLISS) prognostic score for predicting acute respiratory admissions among Chronic Obstructive Pulmonary Disease (COPD) patients — Rachel Jordan ...
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Validation of the Birmingham Lung Improvement Studies (BLISS) prognostic score for predicting acute respiratory admissions among Chronic Obstructive Pulmonary Disease (COPD) patients
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-11
Organisations:
Rachel Jordan - Chief Investigator - University of Birmingham
Rachel Jordan - Corresponding Applicant - University of Birmingham
James Martin - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of Birmingham
Peymane Adab - Collaborator - University of Birmingham
Richard Riley - Collaborator - University of BirminghamOutcomes:
Presence of acute respiratory admissions within 2 years of study entry: diagnostic codes from HES data (J00-06, J09-18, J20-22, J39.3, J39.8, J39.9, J40-47, J60-70, J80-86, J90-98, R05, R06.0, R06.2, R06.5, R09.2, R09.3)
Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a one of the most common long-term conditions. It tends to require increasing numbers of emergency stays in hospital as patients have a âflare-upsâ, often due to common respiratory infections.
We have developed a score which could be used by GPs to predict which of their COPD patients is most likely to be admitted to hospital. This score has great potential to better target COPD care and reduce emergency admissions but requires validation in nationally representative primary care records to demonstrate its use more widely.
We aim to use data from the CPRD Aurum to quantify how the score performs compared to individual components of the score and explore which cut-offs might be used in practice.
COPD patients will be included if aged 40 years or over on Jan 1st 2018 and followed for 2 years to record whether they have an emergency respiratory admission to hospital or not. The score will be calculated using our equation with six components: age, diagnosis of diabetes, emergency respiratory hospital admission in the 12 months prior to study entry, Body Mass Index (BMI), severity of lung function, COPD Assessment Test score (measures impact on patientsâ lives).Predicted risk of emergency respiratory hospital admission will be compared to actual admissions to assess its performance. We will evaluate how much impact it might have on admissions at several different cut-offs.
Technical Summary
We will also calculate the benefit of using the score compared with using individual components alone.Aim: to validate the Birmingham Lung Improvement Studies (BLISS) score in a large, nationally representative primary care Chronic Obstructive Pulmonary Disease (COPD) cohort.
Specific objectives:
â¢Extract COPD patient data from CPRD allowing 2 years follow-up prior to Coronavirus pandemic
â¢Extract and link to Hospital Episode Statistics (HES) data on acute respiratory admissions
â¢Describe baseline characteristics of selected cohort
â¢Validate BLISS prognostic score
â¢Describe net benefit over individual components
â¢Explore different thresholds of the new prognostic score suggested by practising primary healthcare professionalsStudy Design
External validation within a population-based retrospective, fixed cohortPopulation
COPD patients aged 40+ years on Jan 1st 2018Primary exposures:
â¢Age
â¢Presence of diabetes
â¢Acute respiratory hospital admission 12 months prior to study entry
â¢Body Mass Index (BMI)
â¢Forced expiratory volume in 1 second as a % of predicted values (FEV1% predicted)
â¢COPD Assessment Test (CAT) scorePrimary outcome: acute respiratory admissions (from linked HES data) up to 2 years since entry to the cohort
Statistical Analyses
The BLISS score will be calculated for individual patients using the derived equation.
Predicted risk of acute respiratory hospital admission will be compared to the observed outcomes with calibration plot, quantified using calibration slope, calibration-in-the-large, Expected/Observed events + confidence intervals.
Area under receiver operating curve will judge discrimination (c-statistic).
Exploratory analyses to estimate % required to receive a particular intervention and % hospital admissions which could potentially be affected by any intervention, at several risk thresholds.
Decision curve analysis to calculate net benefit of using BLISS score compared with strategies using individual components.
Sensitivity analyses conducted with CAT, BMI, FEV1% recorded in the last 2 and 3 years; use of primary care hospital data instead of linked HES data.
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Multi-region evaluation of the national roll out of social prescribing link workers in primary care — Paul Wilson ...
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Multi-region evaluation of the national roll out of social prescribing link workers in primary care
Datasets:GP data, The first part of the research will determine the characteristics of those who have engagement with social prescribing schemes. This will be identified by the following SNOMED codes:
871691000000100 | Social prescribing offered (finding)
871711000000103 | Social prescribing declined (situation)
871731000000106 | Referral to social prescribing service (procedure) Given the aim of the scheme is to reduce workload within primary care, in the second part of the research we will assess health care utilisation of those referred into social prescribing compared to a similar comparator group. The primary outcome will be measures of primary care activity and workload as defined in Hobbs et al. (1). These will be the number of consultations via a GP, nurse or other medical practitioner, and the consult mode â face-to-face or telephone. We will identify frequent attenders to determine if social prescribing has affected those patients, as they contribute to high workload for GPs (2). We will additionally consider the subsequent onset and management of health conditions (including prescribed medications) as secondary outcomes. Past findings have determined the onset and prevalence of medical conditions across age, sex and ethnicity (3). We will use these conditions and relevant SNOMED codes to identify diagnosis and progression of medical conditions. The hypothesis is that social prescribing is to improve management of health conditions (4). We will assess whether a referral of social prescribing has an effect on prescriptions for patients. We will also assess the effect of social prescribing on secondary care outcomes, as past research has found that there is a reduction in non-elective services (5). We will use the data linkages available within CPRD to assess whether there is a change in the volume of appointments and type of visit â elective or non-elective, and whether in or outpatient. In the third stage of the research, we will cost the primary and secondary care activity to assess the cost effectiveness of the link workers social prescribing. From the outcomes identified previously we will apply unit costs (6) to determine the cost of services used and combine this with information of the fixed and variables costs of operating social prescribing schemes.Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-18
Organisations:
Paul Wilson - Chief Investigator - University of Manchester
Anna Wilding - Corresponding Applicant - University of Manchester
Efundem Agboraw - Collaborator - University of Manchester
Luke Munford - Collaborator - University of Manchester
Matt Sutton - Collaborator - University of ManchesterOutcomes:
The first part of the research will determine the characteristics of those who have engagement with social prescribing schemes. This will be identified by the following SNOMED codes:
871691000000100 | Social prescribing offered (finding)
871711000000103 | Social prescribing declined (situation)
871731000000106 | Referral to social prescribing service (procedure)Given the aim of the scheme is to reduce workload within primary care, in the second part of the research we will assess health care utilisation of those referred into social prescribing compared to a similar comparator group. The primary outcome will be measures of primary care activity and workload as defined in Hobbs et al. (1). These will be the number of consultations via a GP, nurse or other medical practitioner, and the consult mode â face-to-face or telephone. We will identify frequent attenders to determine if social prescribing has affected those patients, as they contribute to high workload for GPs (2).
We will additionally consider the subsequent onset and management of health conditions (including prescribed medications) as secondary outcomes. Past findings have determined the onset and prevalence of medical conditions across age, sex and ethnicity (3). We will use these conditions and relevant SNOMED codes to identify diagnosis and progression of medical conditions. The hypothesis is that social prescribing is to improve management of health conditions (4). We will assess whether a referral of social prescribing has an effect on prescriptions for patients.
We will also assess the effect of social prescribing on secondary care outcomes, as past research has found that there is a reduction in non-elective services (5). We will use the data linkages available within CPRD to assess whether there is a change in the volume of appointments and type of visit â elective or non-elective, and whether in or outpatient.
In the third stage of the research, we will cost the primary and secondary care activity to assess the cost effectiveness of the link workers social prescribing. From the outcomes identified previously we will apply unit costs (6) to determine the cost of services used and combine this with information of the fixed and variables costs of operating social prescribing schemes.
Description: Lay Summary
Social prescribing links patients in primary care with sources of support within the community. With national policy implementation underway across the UK, there is now a need to understand the impact of social prescribing link worker services and how they can be developed in the future. To understand the effectiveness of the scheme, we need to understand the characteristics of those who have access, those who get referred and those who adhere to social prescribing. This will aid in understanding who requires additional support to engage in the scheme. Once we have identified the characteristics of those who engage in the scheme, we will estimate the role of social prescribing on individualsâ health outcomes to assess if there are any improvements in health and changes in health care utilisation. We will determine whether uptake reduces workload within primary and secondary care. We will then assess the cost effectiveness of social prescribing link workers within primary care We will do this by costing the health and care services used by those who engage in social prescribing and comparing it to a matched cohort of people who have not had contact with a social prescribing link worker.
Technical SummarySocial prescribing links patients in primary care with sources of support within the community. With national policy implementation underway across the UK, there is a need to understand the impact of social prescribing link worker services and how they can be developed in the future. We aim to analyse variations in the uptake of social prescribing and impacts on patientsâ health and service outcomes.
The study has three stages. The first is a population cohort study to determine who has access, uptake, and engagement in social prescribing. This will be identified via SNOMED codes within CPRD GOLD and Aurum between 2016 and 2023. We will then use multi-variable logistic regression modelling to identify which population groups require additional support to use social prescribing schemes across population and area-level characteristics. The second stage is a comparative cohort-study analysis using matching algorithms to compare health and service outcomes between those referred in social prescribing (exposed) and non-referred individuals. These outcomes will be identified in primary care through CPRD and in secondary care through data linkages with HES. The third stage will estimate link worker cost-effectiveness in terms of cost per additional person linked to social prescribing schemes and then develop a model to produce a cost-utility analysis. There will also be a consideration of whether a distributional approach substantially affects the future results and assessment of different funding models for link workers. The findings from this research will inform the longevity of the scheme and demonstrate the potential benefits of engaging with social prescribing.
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The association between the COVID-19 vaccine and herpes zoster, bullous pemphigoid and urticaria — Sonia Gran ...
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The association between the COVID-19 vaccine and herpes zoster, bullous pemphigoid and urticaria
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-01
Organisations:
Sonia Gran - Chief Investigator - University of Nottingham
Sonia Gran - Corresponding Applicant - University of Nottingham
Antonia Lloyd-Lavery - Collaborator - Oxford University Hospitals NHS Foundation Trust
Matthew Ridd - Collaborator - University of Bristol
Mikolaj Swiderski - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of Nottingham
Zenas Yiu - Collaborator - University of ManchesterOutcomes:
Study 1: Prevalent cases of bullous pemphigoid (â¥18 years) in primary or secondary care; prevalent cases of herpes zoster (â¥18 years) in primary or secondary care; prevalent cases of urticaria (â¥18 years) in primary care or secondary care.
Study 2: incident cases of bullous pemphigoid (â¥18 years) in primary or secondary care.
Study 3: incident cases of herpes zoster (â¥18 years) in primary or secondary care; incident cases of urticaria (â¥18 years) in primary or secondary care.Description: Lay Summary
Background
Some small studies have shown an association with certain skin conditions (bullous pemphigoid: a rare blistering disease; shingles: a painful and often disabling condition, and urticaria sometimes known as âhivesâ; a painful swelling condition) and the COVID-19 vaccine. All three conditions can lead to serious complications and affect quality of life if not recognised early on.It is important for GPs and other healthcare professionals like nurses and pharmacists to be aware of post-vaccination skin conditions so that patients receive appropriate treatment and do not get worse. It is also important for patients to make informed decisions with their doctors about risks when they consent to vaccination. To purpose of this study is to determine if there is an association between the COVID-19 vaccine and bullous pemphigoid, shingles and urticaria.
Methods
We will use routinely collected patient data from over 1700 GP surgeries across the UK to calculate the risk of developing bullous pemphigoid, shingles or urticaria following administration of the COVID-19 vaccine. This is an efficient way to undertake research on uncommon conditions and it will reveal what happens in healthcare settings across the whole country. We will consider different vaccine types and find out if these skin conditions have increased in the UK since the mass vaccination programme started.Anticipated impact
Technical Summary
A greater awareness of the potential side-effects of the COVID-19 vaccines and which vaccine type may have higher risk. Alternatively, patients may be reassured that bullous pemphigoid, urticaria and shingles are not associated with the vaccines.Aim
The aim of this project is to determine if there is any association with COVID-19 vaccines and skin conditions. The objectives are to determine:
1. the prevalence of bullous pemphigoid (BP), herpes zoster (HZ) and/or urticaria following the COVID-19 vaccine programme
2. relative risk of BP, HZ and/or urticaria following COVID-19 vaccination
3. if relative risk is influenced by type of vaccine and COVID-19 infection.Methods
Data sources: GOLD, AURUM and HES to obtain hospitalisations.Study 1: The effect of the COVID-19 vaccine on the occurrence of BP, HZ and Urticaria.
Study design: cohort study, 2019-2023.
Outcome: BP, HZ and urticaria (â¥18 years)
Negative controls: cases of venous leg ulcers (â¥18 years)
Exposure: calendar period
Analysis: interrupted time series to determine if prevalent rates of BP, HZ and urticaria changed after the COVID-19 vaccine programme.Study 2: COVID-19 vaccine and BP
Study design: nested case-control 2021-2023; this is an appropriate design as BP is uncommon.
Outcome: incident cases of BP (â¥18years).
Controls: up to 4 controls per BP case matched by age, sex and GP practice.
Exposure: COVID-19 vaccination
Analysis: conditional logistic regression to calculate unadjusted/adjusted odds ratios for exposure to the COVID-19 vaccine, overall and by vaccine type and number of doses.Study 3: COVID-19 vaccine and HZ and Urticaria
Study design: self-controlled case series, 2021-2023, to account for within-person confounding.
Outcome: HZ or urticaria (â¥18 years).
Negative control: cases of venous leg ulcer (>18 years)
Exposure: COVID-19 vaccination. The study period will be divided into 0-21 vaccine-exposed, 14-days pre-vaccination, and the remaining vaccine-unexposed periods.
Analysis: conditional Poisson regression adjusted for season; stratified by vaccine dose and by type, and restriction by COVID-19 infection.Patient benefit: knowledge on potential Covid-19 vaccine side-effects so patients can make informed decisions with regards Covid-19 vaccination.
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Artificial intelligence to identify medications in primary care associated with increased risk of keratinocyte skin cancer; an exploratory and nested case control study. — Dimitrios Karponis ...
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Artificial intelligence to identify medications in primary care associated with increased risk of keratinocyte skin cancer; an exploratory and nested case control study.
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-21
Organisations:
Dimitrios Karponis - Chief Investigator - University of East Anglia
Dimitrios Karponis - Corresponding Applicant - University of East Anglia
Daniella Sousa Massri - Collaborator - University of East Anglia
Geoffrey Guile - Collaborator - University of East Anglia
Henry Howard-Tripp - Collaborator - University of East Anglia
James Holmes - Collaborator - University of East Anglia
Jithu Kozhimannil Jose - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Khaylen Mistry - Collaborator - University of East Anglia
Lesley Rhodes - Collaborator - University of Manchester
Mohammad Reza Zafari - Collaborator - University of East Anglia
Nicholas Levell - Collaborator - University of East Anglia
Sonia Gran - Collaborator - University of Nottingham
Wenjia Wang - Collaborator - University of East Anglia
Zenas Yiu - Collaborator - University of Manchester
Zoe Venables - Collaborator - University of East AngliaOutcomes:
Associations (i.e. increased or decreased risk) of medication classes with keratinocyte cancers (i.e. cBCC or cSCC).
This study will use artificial intelligence algorithms to compare patients with a diagnosis of keratinocyte cancer (cBCC or cSCC) between 2010-2019 to age-, sex- and years of GP registration-matched controls without skin cancer, to identify previously received medications associated with risk of cBCC or cSCC.
cBCC: cutaneous basal cell carcinoma; cSCC: cutaneous squamous cell carcinoma.
Description: Lay Summary
Skin cancer is the commonest form of cancer in humans and is divided in 3 types: basal cell cancer, squamous cell cancer and melanoma. Exposure to sunlight, a weaker immune system, environmental toxins and old age are factors that make people more likely to develop a skin cancer. Certain medicines, when taken for long periods of time, may make it more likely for patients to develop skin cancer, for example through making the skin more susceptible to the effect of sunlight one receives.
The aim of this study is to explore links between commonly prescribed medicines and their association with skin cancer.
Data from 79,428 patients in England between 2010 and 2019 with the two commonest types of skin cancer (50,000 with basal cell cancer and 29,428 with squamous cell cancer) will be each matched to 5 patients without skin cancer (397,140 patients in total) through a general practice records database (CPRD). All data will be anonymised to maintain confidentiality. The data will be analysed using modern machine learning and artificial intelligence methods, looking for possible links between medications and the chances of developing skin cancer. If associations are found, data from groups of patients and their other health problems will be analysed to find possible reasons.
The results could assist doctors and patients in better understanding the risk of skin cancer with some medications and tailor drug prescribing to patientsâ best interests.
Technical SummaryCutaneous basal and squamous cell carcinomas (cBCC and cSCC, also known as âkeratinocyte cancersâ) are the commonest forms of skin cancer and their incidence is rising. It is thought that hydrochlorothiazide, amongst other medications known to increase the risk of developing cBCC and cSCC, does so via its photosensitising properties [1,2]. Additionally, immunosuppressive agents particularly increase cSCC risk [3].
The aim of this hypothesis-generating study is to generate clusters of exposures to commonly prescribed medications which are associated with risk of cBCC or cSCC.
A randomised selection of 79,428 cases (50,000 with cBCC and 29,428 with cSCC) in England will be extracted from national primary care data (CPRD Aurum) between 2010-2019. Preliminary counts have yielded over 176,000 cBCC, 29,428 cSCC, and over 20.2 million controls (i.e. patients without a diagnosis of any skin cancer, as per appendix code list). For every case, 5 controls without skin cancer will be matched on age, sex, GP practice and years of registration, using incidence density sampling.To calculate the stratified risk of keratinocyte cancer following exposure to a therapeutic class (or a combination thereof), two approaches will be used: exploratory methods and descriptive statistics. Medications associated with possible risk of keratinocyte cancer will be explored using association rule mining. Patient characteristics associated with risk of cBCC or cSCC will be identified by cluster analysis. Sensitivity analyses will be conducted for those taking medications for a minimum of 1,3 or 6 months to exclude those with other cancer diagnoses, and decide the start of the observation period before index date (i.e. cSCC or cBCC diagnosis), with the end being development of skin cancer, death, date lost to follow up or January 2020.
This information will be used to generate machine learning/deep learning algorithms to assist doctors in identifying patients at risk of keratinocyte cancers.
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Temporal trends in and health conditions associated with "Deaths of Despair" (suicides, alcohol- and drug-related deaths): analysis of interlinked primary and secondary healthcare and mortality records — Roger Webb ...
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Temporal trends in and health conditions associated with "Deaths of Despair" (suicides, alcohol- and drug-related deaths): analysis of interlinked primary and secondary healthcare and mortality records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-01
Organisations:
Roger Webb - Chief Investigator - University of Manchester
Maja Radojcic - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Sarah Steeg - Collaborator - University of ManchesterOutcomes:
Mortality, i.e., Deaths of Despair - suicides, drug-related deaths, and alcohol-specific deaths.
Morbidity, i.e., Diseases of Despair - suicide ideation, self-harm, depression, substance, and alcohol misuse.Description: Lay Summary
Research interest in âDeaths of Despairâ, defined as deaths from suicide, drug poisoning, and alcohol-related conditions, is growing internationally. These deaths are assumed to reflect socioeconomic influences on psychological distress in a population. Studies up to 2017 in the UK found an increasing trend of Deaths of Despair and higher rates in men than women. However, the impact of the COVID-19 pandemic, poverty and ethnic differences on Deaths of Despair have not yet been investigated. It is critical to address this knowledge gap, as previous reports indicated that the pandemicâs impact has been more pronounced among socially disadvantaged groups. We aim to examine changes over time since 2000 in Deaths of Despair occurrence, overall and by each type separately in England. We will investigate these changes by the level of deprivation, urban versus rural neighbourhoods, ethnicity, and the effect of the pandemic and economic inflation (increase in prices) on these trends. We will also investigate changes in presentations to the healthcare system of health conditions likely to precede these deaths, such as self-harm and alcohol-induced liver disease. Finally, we will examine groups of health conditions associated with each cause of death. This approach will explore whether and how medically complex are Deaths of Despair and inform the development of interventions that aim to reduce their occurrence.
Technical SummaryWe will utilise CPRD Aurum data for conducting individual-level research on Deaths of Despair (suicide, drug-related and alcohol-specific deaths) in England to supplement the existing ecological ONS reports. We will investigate all Deaths of Despair, and each type separately, during 2000-2022, estimating age- and sex-standardised annual incidence rates stratified by ethnicity, area-level deprivation, and urbanicity of residence. We will investigate changes in temporal trends using joinpoint regression and use the annual inflation rate as an indicator of national economic performance over the study period. We will examine the impact of the COVID-19 pandemic by focusing on the period 2013-2022 at a monthly (seasonal) level. We will use mean-dispersion negative binomial regression models to estimate expected incidence trends, March 2020 onwards, based on pre-pandemic data. The pandemic effect will be inferred from the difference between observed and predicted estimates. We will generate descriptive statistics on drug-related deaths, including substance type and recreational/prescribed use. The same analyses will be conducted for Diseases of Despair (suicidal ideation/behaviours, drug and alcohol misuse). These analyses will utilise interlinked primary and secondary healthcare data to provide evidence on the burden of morbidity and mortality. Finally, for each Death of Despair type, we will examine patientsâ medical history (a year proceeding the death and at any time in the patientâs history), including primary and secondary healthcare contacts, diagnoses, and medication prescribing, using association network analysis to identify their co-occurrence patterns. These findings will determine if there are particularly vulnerable groups according to their health and socioeconomic descriptors. Ultimately, this research will provide clinicians with the health profile of these individuals and inform public health policies and initiatives. Understanding the impact of despair and its associated health and sociodemographic factors will inform national guidelines and contribute to developing effective preventive measures and interventions to mitigate premature mortality.
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From symptoms to first acute exacerbation of chronic obstructive pulmonary disease: what has changed over time? — Alex Bottle ...
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From symptoms to first acute exacerbation of chronic obstructive pulmonary disease: what has changed over time?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-14
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Alex Bottle - Corresponding Applicant - Imperial College London
Alexander Adamson - Collaborator - Imperial College London
Benedict Hayhoe - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College LondonOutcomes:
Setting where COPD first recorded (primary or secondary care); NICE guideline compliance for diagnosis; First acute exacerbation (AECOPD)
Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) describes a group of long-term lung conditions. It affects over a million people in the UK alone, reduces quality of life and costs the NHS a lot to treat. It can be hard to diagnose, but little is known about how patients get their diagnosis, for instance if itâs when seeing their GP, following various tests or during an emergency admission to hospital. Using patient data from GP computer systems linked to hospital admissions records, this project will increase our understanding of how long it takes to get diagnosed and whether some types of patients have longer times to diagnosis than others. This knowledge is the first key step to help the NHS improve care for patients with COPD.
A common consequence of COPD is that breathing can quickly get much harder (known as an acute exacerbation, AECOPD), causing lung damage. If we can predict early on which patients are the most likely to go on and have an AECOPD before too much damage is done, then treatment and monitoring can be adjusted to prevent many further AECOPDs. We will do this by building statistical models that predict the risk of AECOPDs based on factors such as the patientâs age, smoking, blood pressure and medical history. This modelling aims to rank these patient factors in public health importance and thereby give some direction to the NHS to prioritise its care improvement efforts for people with COPD.
Technical SummaryAims and objectives: To describe and model the patient journey from symptom presentation to diagnosis and first acute exacerbation for COPD patients in England. This will include examining variations by GP practice and time period, followed by the construction and internal validation of a risk prediction or risk trajectory model for the first AECOPD.
Methods: Using the Clinical Practice Research Datalink (CPRD) and three cohorts, we will describe the management of the patient following initial presentation with symptoms through to their diagnosis of COPD and their first AECOPD, which for some patients will be the same event. The cohorts will be for 2006, 2016 and the first COVID wave (March to August 2020). Given that COPD can present differently depending on comorbidity, the mapping will be described separately for people with asthma and heart failure in particular. We will assess compliance with NICE guidelines for diagnosis, including practice-level variation in spirometry. The second part will model the risk of the first AECOPD using factors such as airways obstruction, age, smoking, BMI, gender, comorbidities and medications. This will use Cox proportional hazards modelling. Population attributable fractions will be calculated for each predictor. Models will be cross-validated and assessed for discrimination and calibration.
Anticipated impact and dissemination: This study will fill key gaps in our understanding of how patients obtain their COPD diagnosis (their âroute to diagnosisâ), how they are managed in primary care, and how they get their first AECOPD. Comparisons between the three time periods will highlight what has changed, including during the early part of the pandemic, and inform NHS preparation for future needs regarding COPD. If it performs well, a risk prediction model for first acute exacerbation will aid shared decision-making between GPs and patients and facilitate early intervention; ranking the predictors will suggest priorities for action.
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Development and validation of risk scoring tools for acute exacerbations and cardiovascular outcomes among patients with chronic obstructive pulmonary disease (COPD). — Mohsen Sadatsafavi ...
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Development and validation of risk scoring tools for acute exacerbations and cardiovascular outcomes among patients with chronic obstructive pulmonary disease (COPD).
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-27
Organisations:
Mohsen Sadatsafavi - Chief Investigator - University Of British Columbia
Joseph Emil Amegadzie - Corresponding Applicant - University Of British Columbia
Amin Adibi - Collaborator - University Of British Columbia
Jennifer Quint - Collaborator - Imperial College London
John Hurst - Collaborator - University College London ( UCL )
Mona Bafadhel - Collaborator - King's College London (KCL)
Richard Russell - Collaborator - King's College London (KCL)Outcomes:
Acute Exacerbations of chronic obstructive pulmonary disease (COPD)
Coronary heart disease
Ischaemic stroke
Transient ischaemic attackDescription: Lay Summary
Chronic obstructive pulmonary disease is a common illness affecting the lungs and making breathing difficult. When chronic obstructive pulmonary disease suddenly worsens, it is called a "lung attack." People living with this lung condition often have other health issues, more commonly than the general population, especially heart problems. To provide better care, doctors need ways to predict when lung or heart attacks are more likely. However, existing ways of using routine data to predict when someone is going to have a heart attack that are used for the general population may not be as effective for people living with Chronic obstructive pulmonary disease. This study aims to use de-identified information from primary and secondary care to develop and test tools to predict when lung attacks are more likely to happen and to validate and modify existing heart attack risk assessment tools for people with chronic obstructive pulmonary disease. Achieving this will benefit people living with chronic obstructive pulmonary disease, as it can help determine high-risk periods, allowing for preventive measures and better patient care.
Technical SummaryPeople with chronic obstructive pulmonary disease (COPD) often experience exacerbations and face a higher risk of cardiovascular diseases (CVD) than the general population. COPD exacerbations and CVD contribute to most excess mortality in COPD. As exacerbations can cause a significant decline in overall health, predicting who is at high risk can significantly improve and optimize risk mitigation strategies, including preventive pharmacotherapy.
To the best of our knowledge, no validated exacerbation risk scoring tool exists for the UK COPD population, and current tools rely on positive exacerbation history and cannot predict the first exacerbation, limiting their usefulness upon COPD diagnosis. Further, COPD is now recognized as an independent risk factor for CVD. Therefore, risk scoring tools such as the QRISK which are recommended for the general population are at risk of underestimating CVD risk in COPD patients and thus result in suboptimal preventive strategies. As such, before using CVD and exacerbation risk scoring tools, it is essential to validate and, if necessary, update them. Through this project, we will validate ACCEPT and QRISK3 using the CPRD Aurum database (January-2004 to December-2022) by evaluating their calibration, discrimination, and clinical utility by drawing the calibration plot, calculating area-under-the-curve, and conducting decision curve analysis. We will evaluate the performance of ACCEPT 2.0 in predicting the time to the first COPD exacerbation and, if required, will re-estimate coefficients of ACCEPT 2.0 to predict such an outcome. We will also evaluate fairness and equity metrics, including calibration in subgroups of sex, socio-economic status, and ethnicity. If ACCEPT and QRISK3 are not calibrated, we will follow best practice standards in updating such tools to generate improved predictions. This research will benefit COPD patients by determining high-risk periods for exacerbations and heart conditions, enabling preventive measures and better management.
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A feasibility study to estimate subgroups of atrial fibrillation population — Bersabeh Sile ...
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A feasibility study to estimate subgroups of atrial fibrillation population
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-25
Organisations:
Bersabeh Sile - Chief Investigator - Bayer AG
Luis Alberto Garcia Rodriguez - Corresponding Applicant - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Oscar Fernández Cantero - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )Outcomes:
-Absolute number of prevalent and incident atrial fibrillation (AF) patients in CPRD GOLD and AURUM according to our operational definition (as listed in technical summary);
-Characterization of AF sub-populations based on CHA2DS2Vasc scores;
-Co-medications: oral anticoagulants and antiplatelets;
-Co-morbidities: hypertension, diabetes, stroke, transient ischemic accident, venous thromboembolism, myocardial infarction, peripheral arterial disease, atherosclerosisDescription: Lay Summary
Atrial fibrillation (AF) is an irregular heartbeat, or arrhythmia, that can lead to blood clots and stroke. AF is progressively more common with aging, is associated with substantial morbidity and mortality, and the risk of stroke is five-fold higher compared to patients without AF. This stroke risk is not the same for everyone and depends on having specific health characteristics, called risk factors. It is important to identity these stroke risk factors and categorize subgroups of patients who are likely to be at greater risk of stroke, as not all AF patients are the same and some may require different treatment than others. The commonly used CHA2DS2-VASc scoring system will be used to group patients based on their risk of stroke, then into corresponding smaller groups that require oral anticoagulant treatment to help reduce their individual risk of stroke.
Technical Summary
Using data from the Clinical Practice Research Datalink (CPRD) database in the United Kingdom, we want to identify AF subgroups (sub-populations) of patients based on their level of risk of stroke using the CHA2DS2-VASc Score, as well as other comorbidities: hypertension, stroke, transient ischemic accident, venous thromboembolism, myocardial infarction, peripheral artery disease atherosclerosis and diabetes. We will explore the overlap between the various subgroups and the number of patients in each of these subgroups will help guide future research exploring the reduction of stroke risk.Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia in adults, with prevalence between 2-4%, and increasing progressively with age. AF is associated with substantial morbidity and mortality, amplifies the risk of stroke five-fold compared to non-AF patients. The CHA2DS2-VASc Score permits stratification of AF patients based on several stroke risk factors, creating AF subgroups at different risk of stroke.
Using data from the UK databases CPRD Gold and Aurum, we propose to conduct a feasibility analysis to ascertain the size of the AF population receiving anticoagulation, stratified into different stroke risk subpopulations.
During the enrolment period (1/1/2012-30/06/2022), all individuals aged â¥18 years of age and registered for at least two years in CPRD database will constitute the source population and the day they meet these two criteria will be their entry date. We will identify two separate study cohorts: 1) Incident AF described as patients with a first ever AF recorded diagnosis after their entry date, a CHA2DS2VASc score â¥2 if male, or CHA2DS2VASc score â¥3 if female, and receiving oral anticoagulation (OAC) at the time of their AF first diagnosis, or 2) Prevalent AF described as patients with a AF recorded diagnosis before their entry date, a CHA2DS2VASc score â¥2 if male, or CHA2DS2VASc score â¥3 if female, and receiving oral anticoagulation (OAC) at the time of their entry date.
Objectives: To estimate absolute size of AF population classified in different subgroups based on CHA2DS2-VASc score, as well as to explore distribution of additional comorbidities and drug use in these subgroups. We will produce detailed descriptive analyses of demographic characteristics, cardiovascular risk scores, co-medications and comorbidities among the various AF sub-populations.
Based on findings, we may conduct additional research to explore the value of anticoagulant treatment in reducing stroke and other vascular events.
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Reproducibility of estimates of prevalence of rare blood cancers from DARWIN EU in the Clinical Practice Research Datalink from primary care sources and assessing the impact of including hospital derived data — Craig Currie ...
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Reproducibility of estimates of prevalence of rare blood cancers from DARWIN EU in the Clinical Practice Research Datalink from primary care sources and assessing the impact of including hospital derived data
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-14
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence of six rare blood cancers: Acute lymphocytic leukaemia (ALL), Acute myeloid leukaemia (AML), Chronic lymphocytic leukaemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular lymphoma (FL) and Multiple myeloma (MM).
Description: Lay Summary
In order to get a better understanding of the impact that diseases can have within a population a key requirement is to understand how many people have the disease at any one time (prevalence). Measures of prevalence are essential to allow the National Health Service and other organisations to plan service provision. It is therefore important that these measures should be accurate and well estimated. In this study we wish to compare estimates from the Data Analysis and Real World Interrogation Network (DARWIN EU) on six rare blood cancers with estimates derived from using our internal algorithm. In comparison to DARWIN, we aim to use a larger data source which is linked to hospital data in order to obtain more accurate estimates of each rare blood cancer. We will reproduce the study by DARWIN as close as possible by replicating code lists, study periods and definitions of disease periods. Accurate prevalence estimates are vital in assessing disease burden and are essential for informed public health decision-making.
Technical SummaryWe have developed an internal algorithm to define a disease and generate epidemiology reports, including estimates of prevalence. In order to validate these estimates, we aim to investigate a study conducted by DARWIN EU which analyses the prevalence of six rare blood cancers in Europe. The cancers of interest are Acute lymphocytic leukaemia (ALL), Acute myeloid leukaemia (AML), Chronic lymphocytic leukaemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular lymphoma (FL) and Multiple myeloma (MM). The Clinical Practice Research Datalink (CPRD) GOLD database was utilised for their lifelong, 5-year and 2-year prevalence estimates. In order to reproduce these estimates as consistently as possible, we will use the code lists provided for each cancer, replicate the study periods and other constraints described in the study. However, we use a combined data source of CPRD GOLD and Aurum to replicate the estimates in primary care. We will also explore the use of linked Hospital Episode Statistics (HES) and investigate prevalence using a larger combined CPRD and linked HES data source, allowing for a wider scope and better estimation of prevalence for each rare blood cancer.
For 5-year and 2-year partial prevalence, patients will be defined as a prevalent case for the corresponding duration after first diagnosis. We will define the prevalence of the condition as the proportion of the population who have the condition in a given year. Point prevalence will be calculated for each of the 3 disease periods. We will then compare the values produced by our algorithm to those reported by DARWIN using the Z-test.
By conducting this validation study, we aim to improve the accuracy of estimates of prevalence using routine data sources. This will ultimately benefit public health by ensuring more reliable and accurate information for epidemiological analysis and decision-making.
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Treatment patterns and drug utilisation for medicines of regulatory interest in autoimmune disease — Daniel Prieto...
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Treatment patterns and drug utilisation for medicines of regulatory interest in autoimmune disease
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-08
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Eng Hooi Tan - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of OxfordOutcomes:
Drug utilisation and treatment patterns
Description: Lay Summary
The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe. One area of research relates to estimating how often and for how long specific medicines of interest are prescribed and/or dispensed. For regulators it is important to have access to this information as it provides insight in the uptake of specific medicines in the community and whether use of these medicines changes over time influenced by regulatory measures to protect public health such as withdrawal of medication, change in labelling, safety warnings etc.
Technical Summary
The objective of this study is to describe the treatment patterns of specific medicines of interest. We will describe these patterns, in particular time of starting medication from diagnosis, combination of medication types, and sequence of treatment. All these will be calculated in specific populations of interest based on age and sex groups, and over calendar years to look at possible changes over time. Secondly, we will look at the indications or reasons for these medicines, and how long and at what strength they are prescribed. We will also explore characteristics of patients prescribed/dispensed the drugs in terms of medical conditions and concomitant medicine use.Primary care records provide a unique source of data for describing treatment patterns and medication use in the community, as most medicines are prescribed by general practitioners. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the uptake of specific drugs of interest and to study routine clinical practice and the effect of regulatory actions on drug prescribing/dispensing, EMA will commission several drug utilisation and treatment pattern studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: All people in CPRD GOLD or CPRD Aurum with >=1 year of prior history will be eligible, with sensitivity analyses using different prior history requirements.
Variables: Drug exposure based on prescription data as available within CPRD GOLD or CPRD Aurum. Drugs will be selected by means of the respective RxNorm codes.
In addition, the characteristics of patients being diagnosed with condition(s) of interest and prescribed/dispensed the drug(s) of interest will be described, and the use of the prescribed medicine over time assessed in terms of indication of
use, duration, strength and/or dose. Treatment patterns will also be described in terms of time of initiation from diagnosis, combination types and sequence of therapy.
Population and Drug of interest as expressed by EMA:
⢠Systemic lupus erythematosus (SLE) and treatments of SLE in paediatric and adult population
Additional study populations and medicines will be declared in future protocol amendments upon by EMA to the DARWIN Coordination Centre.
Analyses: Drug utilisation and treatment patterns stratified by age, sex, and calendar year. Description of
patient characteristics at diagnosis or therapy initiation, and use of medicine/s over time.
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Use of systemic fluoroquinolones in the UK: a drug utilisation study — Daniel Prieto...
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Use of systemic fluoroquinolones in the UK: a drug utilisation study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-22
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Helen Booth - Corresponding Applicant - CPRD
Daniel Dedman - Collaborator - CPRD
Edward Burn - Collaborator - University of Oxford
Katherine Donegan - Collaborator - MHRA
Zara Cuccu - Collaborator - CPRDOutcomes:
The primary outcome of the study is prescribing of fluoroquinolones. The individual medications are Ciprofloxacin; Delafloxacin; Levofloxacin; Moxifloxacin; Norfloxacin; Ofloxacin.
For objective 1 the incidence and prevalence of fluoroquinolone prescribing will be calculated, and for objective 2 the duration and dosage.
Description: Lay Summary
Fluoroquinolones are antibiotics that have long been used to treat a variety of infections. More recently, rare but serious and potentially disabling side effects have been related to the use of fluoroquinolones. These include inflammation or rupture of tendons and nerve damage. A safety review by the European Medicines Agency was conducted and measures were put in place to limit the use of fluoroquinolones that were disseminated in the UK in 2019, including recommendations to restrict use in for less severe infections and in vulnerable patients such as those over the age of 60.
The aim of this study is to assess the impact of these safety measures by describing prescribing of fluoroquinolones over time, and characterising the patients who they were prescribed too. This will include description of characteristics such as age, gender and health issues. We will also try to explore the reasons they were prescribed fluoroquinolones to see if this has changed over time. This study will help us to understand whether the safety measures introduced to restrict prescribing of fluoroquinolones have taken effect or whether additional measures need to be implemented.
Technical SummaryIn recent years, rare but severe and potentially disabling adverse events have been related with the use of systemic fluoroquinolones, including tendonitis, tendon rupture, peripheral neuropathy, and possibly aortic aneurism. This led to risk minimisation measures (RMMs) after a safety review by the European Medicines Agency, disseminated nationally in the UK in March 2019.
This study will assess the impact of these RMMs by monitoring the incidence and prevalence of fluoroquinolone prescribing in adults and children, and by characterising the population they are prescribed too in terms of sociodemographics, clinical characteristics and indications for use. The study period will be 2012 to 2022.
A retrospective cohort design will be utilised to answer the study objectives; the cohort will be restricted to new-users to evaluate incidence and describe patient characteristics. Monthly period prevalence and incidence rates will be calculated. The incidence rates will be used in time-series analyses to explore changes in prescribing in relation to the RMMs (interrupted time-series, ARIMA, difference-in-difference). To describe new-users of fluoroquinolones summary statistics will be tabulated to present treatment duration, dose, indication for treatment and patient characteristics.
The analyses will be conducted separately in other health databases, including secondary care data and an international comparator, to better understand and contextualise fluoroquinolone prescribing over the period in relation to the RMMs imposed.
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Management of people with asthma in primary care by smoking status: a descriptive cohort study — Jennifer Quint ...
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Management of people with asthma in primary care by smoking status: a descriptive cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-20
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Maisarah Halim - Collaborator - Imperial College London
Sarah Cook - Collaborator - Imperial College LondonOutcomes:
The following outcomes will be investigated:
1) Time to first inhaled corticosteroid (ICS) prescription following asthma diagnosis
2) Time to first asthma annual review within 18 months of asthma diagnosis
3) Of those who had an asthma annual review visit within 18 months, the proportion who specifically had an inhaler check, an asthma action plan, and were asked the royal college of physicians (RCP) asthma 3 questions.Description: Lay Summary
Smoking is linked to a large range of health problems. Not only can it cause certain diseases, it can also make diseases worse if people continue to smoke. Asthma is a common disease that affects the lungs and makes it hard for people to breathe. If people with asthma continue to smoke, it can make their asthma worse. Good management and treatment can have a big impact on how asthma affects peoplesâ lives and their health across their lives. People who smoke might also be reluctant to visit their GP if they think they will be blamed for smoking or the emphasis of the conversation is just about quitting smoking. It is also possible that people who smoke may also be treated differently by healthcare professionals, despite what asthma management guidelines recommend. This could lead to worse asthma in people with asthma who smoke compared with people with asthma who do not smoke, for example they could end up going to hospital more often due to their asthma. Therefore, it is vital that we understand whether people with asthma who smoke are managed and treated the same was as people with asthma who do not smoke.
Technical SummaryAsthma is a chronic respiratory condition characterised by wheeze and breathlessness. Appropriate management can have a significant impact on patient outcomes. Smoking is a risk factor for many chronic conditions, and even when it does not cause disease, it may make disease worse. Smoking has a high potential for negative social perceptions (stigma) relating to
perceptions of disease attribution or patient âblameâ for their condition since there is may be a perception that these factors are related to an individualâs behaviour and therefore directly under their control. Where health conditions are associated with stigma this can lead to worse health outcomes through variation in patient pathways, at both a patient and the healthcare level.It is not known whether patients who have asthma and also smoke receive different treatment or management to those who do not and to what extent stigma is a modifiable factor involved in differential treatment/management. This is important to explore in order to address potential health inequalities. Inhaled corticosteroids prescriptions and asthma annual review visits are two asthma management variables that do not differ by smoking status according to asthma management guidelines. However, it is unknown whether stigma around smoking leads to differences in asthma management. Using CPRD Aurum primary care data linked with hospital inpatient data and socioeconomic status data (IMD), we will determine a population of people diagnosed with asthma and investigate whether baseline smoking status (never, ex, or current smoking) is associated with differences in 1) time to first inhaled corticosteroid prescriptions, 2) time to first asthma annual review, and 3) the proportion of people who had an inhaler check, an asthma action plan, and were asked the royal college of physicians (RCP) asthma 3 questions using Cox proportional hazards and descriptive statistics.
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A descriptive study measuring the uptake of NICE (National Institute for Health and Care Excellence) guidance on cardiovascular disease risk assessments and lipid lowering therapies for primary and secondary prevention of cardiovascular disease — Tsz Wing Vanessa Kam ...
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A descriptive study measuring the uptake of NICE (National Institute for Health and Care Excellence) guidance on cardiovascular disease risk assessments and lipid lowering therapies for primary and secondary prevention of cardiovascular disease
Datasets:GP data, Patient Level Index of Multiple Deprivation; CCG Pseudonyms
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-20
Organisations:
Tsz Wing Vanessa Kam - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Tsz Wing Vanessa Kam - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Robert Willans - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Key variables (descriptive study):
Cardiovascular disease risk assessment; age; deprivation; gender; type 2 diabetes; hypertension; CVD (stroke, transient ischaemic attack [TIA], coronary heart disease [CHD], peripheral arterial disease [PAD]; statins (atorvastatin 20mg; atorvastatin 80mg; low-, medium- and high-intensity); total cholesterol; high-density lipoprotein (HDL) cholesterol or non-HDL cholesterol; low-density lipoprotein (LDL) cholesterol; alanine aminotransferase; aspartate aminotransferase
Description: Lay Summary
This analysis aims to examine how well NICEâs healthcare guidelines for assessing and managing cardiovascular disease risk are being followed.
First, we want to understand who is receiving assessments to check their risk of cardiovascular disease (CVD). We'll look at the kinds of patients who get these assessments, which tools are used, and the scores they receive.
Next, we'll focus on two groups of patients: those with high blood sugar or high blood pressure. We want to see if these higher-risk individuals are getting CVD assessments, as advised by NICE.
We're also interested in how often a type of medication, statins, is being used to prevent and treat CVD. For both people at risk of CVD (primary prevention) and people who already have CVD (secondary prevention), we'll see how many are taking the right type and dose of statin. Because some patients might not be getting the best treatment, we'll investigate if those with CVD were put on the right type of statin after their first heart-related event.
Lastly, we'll look at whether patients who start taking strong statins have their cholesterol and liver function checked within 3 months. This is important to ensure their safety and effectiveness.
For all these findings, weâll also explore whether there are differences based on a personâs age, gender and how deprived the area they live in is.
The results will help make sure healthcare providers follow best practices, and they'll also guide future updates to the NICE guidelines for cardiovascular health.
Technical SummaryThis study measures the uptake of the NICE quality standard on cardiovascular risk assessment and lipid modification in primary care using CPRD Aurum. The objectives are to understand cardiovascular disease (CVD) risk assessment by characterising patients who received an assessment, which CVD risk tool was used and their scores. We will then look at the proportion of patients with type 2 diabetes or hypertension who received a CVD risk assessment to understand whether populations at increased risk of CVD are having their risk monitored.
We will then look at statin use for primary and secondary prevention of CVD. For primary prevention, we will measure the proportion of patients who have a QRISK score of 10% or more who are on atorvastatin 20mg (NICE-recommended). For secondary prevention, we will measure the proportion of patients with CVD who are on atorvastatin 80mg (NICE-recommended). As many CVD patients are on suboptimal statins, we will look at the proportion of CVD patients on statins who were on statins prior to their first CVD event and whether they received the recommended high-intensity statin following their CVD diagnosis.
Finally, we will look at reviews following initiation of high-intensity statins, critical for the efficacy and safety of statin treatment. We will measure the proportion of patients started on a high-intensity statin who had their cholesterol and liver function reviewed within 3 months.
This is a descriptive study with no statistical testing. The study populations and outcomes are evident from the wording of the proportions. To detect health inequalities, we will look at variation in uptake by age, gender and deprivation. The results will help NICE provide actionable intelligence to local partners and update our guidance, ensuring patients at high risk of CVD are managed and, alongside patients with CVD, are treated appropriately with lipid lowering therapies.
Source -
Does the cumulative dose of aspirin affect cancer risk — Colin Crooks ...
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Does the cumulative dose of aspirin affect cancer risk
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-28
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Colin Crooks - Corresponding Applicant - University of Nottingham
David Humes - Collaborator - University of Nottingham
Joe West - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of NottinghamOutcomes:
1. Cancer diagnosis coded in cancer registry categorised by site (ICD 10 coding and site coding) ;
2. Cancer stage and grade categorised by site coded in cancer registry categorised by site (ICD 10 coding, behaviour, morphology, TMN staging, diagnosis at death, and also including cancer specific staging for colon, prostate, breast, uterine and melanoma, and using treatment data to stage if not formal staging not available);
3. Post cancer survival in ONS death registry categorised by site in coded in cancer registry;
4. All cause mortality in ONS death registry;
5. Cardiovascular events from linked HES, ONS death registry, and primary care CPRD GOLD and AURUM data;
6. Gastrointestinal bleeding from linked HES, ONS death registry, and primary care CPRD GOLD and AURUM data;
7. Cerebrovascular events (both bleeding and ischaemic) from linked HES, ONS death registry, and primary care CPRD GOLD and AURUM data;
Description: Lay Summary
Aspirin is a cheap medication that is taken commonly by many patients to reduce the risk of heart attacks and strokes. There is preliminary evidence that it might also be able to reduce early cancer changes and therefore reduce the risk of cancer. However, there are potentially bad effects of aspirin, for example causing ulcers and bleeding in the stomach. A recent study looking at the risks and benefits controversially suggested that widespread use of aspirin in elderly patients would actually increase their risk of dying.
Technical Summary
Purpose:
This study will look what the current risks and benefits of taking aspirin are in a large study in the English population. We will follow all patients who have evidence of taking aspirin in their GP records through their adult life, and compare the association of the cumulative dose of aspirin with both the potential benefits, including reducing cancer and heart problems, balanced against the potential harms like increased bleeding from the stomach and gut.
Importance:
This will benefit patients by providing contemporary evidence on to support either widespread guidance advising patients who do not have established disease to take aspirin as a preventative medication, or more restrictive advice for specific patient groups if there is an harm for some patients who do not have established disease.Background: That aspirin can reduce the risk of colorectal and possibly other cancers has recently been challenged by the finding of an increased mortality risk in the elderly from the ASPREE study. This suggested that widespread unselected aspirin use in the elderly was harmful, and therefore chemo-preventative effects might be outweighed by aspirin harms. Therefore we will examine what the current risks and benefits of aspirin use are in the general population.
Study Aim: The proposed study will measure the contemporary risks and benefits of aspirin in a large population based cohort
Primary exposure: Cumulative aspirin dose
Outcomes identified in cancer registry, primary care, ONS death registry and secondary care:
1) Cancer incidence categorised by site from linked cancer registry data
2) All cause mortality fron ONS death registry
3) Cardiovascular events from linked HES, ONS death registry, and primary care CPRD data
4) Cerebrovascular events (both bleeding and ischaemic) from linked HES, ONS death registry, and primary care CPRD data
5) Gastrointestinal bleeding from linked HES, ONS death registry, and primary care CPRD data
Study design: This will include all patients with prescribed aspirin use plus an equal sized randomly sampled control group of non aspirin users. The study design will be an open cohort with patients entering and leaving the cohort depending on when they are observed in the CPRD dataset, with follow up time counted from their 18th birthday.
Analysis plan: The cohort will be expanded and split so that time is at a yearly resolution. Cumulative aspirin use will be calculated as a time varying covariate at this one year resolution. A Cox proportional hazards model will then be used to predict the hazard of cancer diagnosis from the time varying cumulative dose of aspirin. This will be adjusted for sex, other relevant medications and co-morbidity.
Source -
Cardiovascular risk with discontinuation of sodium-containing medications after a hypertension diagnosis — Li Wei ...
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Cardiovascular risk with discontinuation of sodium-containing medications after a hypertension diagnosis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-09-20
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Sohee Park - Corresponding Applicant - University College London ( UCL )
Chengsheng Ju - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )Outcomes:
The outcome of interest will be 3-point major adverse cardiovascular events (3P-MACE; including myocardial infarction, stroke, and cardiovascular death), and hospitalisation for heart failure. The secondary study outcomes will be individual outcome of 3P-MACE and all-cause death.
Description: Lay Summary
Some types of medicines, like effervescent, dispersible, and soluble formulations, contain a substance called 'salt,' which helps these medicines work better and be more convenient to use. However, taking such medicines can add to the amount of salt we consume daily, possibly leading to unintentional and harmful effects on our health. Studies have already shown that reducing salt intake can be beneficial for people with high blood pressure, as it lowers their risk of heart diseases.
Now, we want to find out if stopping these salt-containing medicines can also have similar benefits for people who have developed high blood pressure after using these drugs. To do this, we will be looking at data from the Clinical Practice and Research Datalink. By comparing the risks of heart-related problems when people stop taking these salt-containing medicines versus those who continue to take them, we hope to learn whether stopping these medicines can help prevent heart diseases.
The information from this study will be essential for doctors and public health experts to make better decisions about the use of these medicines and develop strategies to reduce the potential harmful effects of excessive salt intake.
Technical SummaryThis study aims to assess the association between discontinuation of sodium-containing drugs after developing hypertension and cardiovascular events by applying a cohort study design with sequential trials emulation approach. The study population includes individuals aged â¥60 years who have been newly diagnosed with hypertension and receive regular treatments with sodium-containing drugs before initial hypertension diagnosis during 2004-2022. Regular treatment with sodium-containing medications is defined as having â¥2 prescriptions of same class within 180 days prior to the hypertension diagnosis. Treatment strategies in this study are (1) discontinuation and (2) continuation of sodium-containing drug use after the initial hypertension diagnosis. The primary outcomes are major adverse cardiovascular events (composite of nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) and hospitalisation for heart failure. Secondary outcomes include individual components of major adverse cardiovascular events and all-cause death. We will use prescription records from primary care data to ascertain patientsâ compatible treatment strategy, and primary care, HES and ONS data for outcome ascertainment. We will estimate risks of outcomes in people who discontinue the sodium-containing drug after hypertension diagnosis comparing people who continuously use. We will emulate a sequence of target trials during each three months from initial hypertensive diagnosis through up to five years (each with a 3-month enrolment period). For each sequential trial, we will identify eligible patients who continued sodium-containing drug until the previous period and assigned them to sodium-containing drug discontinuation or not at that period. Pooled logistic regression model will be used as the outcome model to pool the data from all sequential trials into a single model. We will then several subgroup and analyses and sensitivity analyses to assess the robustness of the results. This proposed research can generate important evidence to guide deprescribing of sodium-containing medications that could reduce cardiovascular disease burdens.
Source -
ID-158-3: Extension: Impact of organisational models in general practice on patient safety and associated costs — Imperial College London...
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ID-158-3: Extension: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: General Practice.
Source -
ID-369: Identifying patients at risk of somatisation/BDD — Optum/NWL ICB...
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ID-369: Identifying patients at risk of somatisation/BDD
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Optum/NWL ICB
Description: Somatisation.
Source -
ID-166-3: Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity. — ICHP...
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ID-166-3: Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Obesity. Commercial
Source -
ID-135-5: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease — Lane Clark & Peacock LLP...
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ID-135-5: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Cardiovascular Disease.
Source -
ID-304-1: Extension: TRICORDER – Triple Cardiovascular Disease Detection with an Artificial Intelligence-Enabled Stethoscope — Imperial College London...
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ID-304-1: Extension: TRICORDER – Triple Cardiovascular Disease Detection with an Artificial Intelligence-Enabled Stethoscope
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Cardiovascular Disease. Commercial
Source -
ID- 370: A study to assess the effects of a randomised community health worker-led intervention on uptake of preventative care services in London, UK — Imperial College London...
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ID- 370: A study to assess the effects of a randomised community health worker-led intervention on uptake of preventative care services in London, UK
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Community Health.
Source -
ID-212-3: Estimating inequalities in burden of illness in patients with Alzheimer’s disease — Lane Clark & Peacock LLP...
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ID-212-3: Estimating inequalities in burden of illness in patients with Alzheimer’s disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Alzheimer’s Disease. Commercial
Source -
ID-368: Hepatitis C Risks for Patients within North West London – conditionally approved subject to amending 1.4 and reviewing 5.1. — Chelsea and Westminster Healthcare NHS Trust...
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ID-368: Hepatitis C Risks for Patients within North West London – conditionally approved subject to amending 1.4 and reviewing 5.1.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-23
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Healthcare NHS Trust
Description: Hepatitis C. Commercial
Source
2023 - 08
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ADR UK Research Fellows: Understanding experiences of the family justice system — unknown...
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ADR UK Research Fellows: Understanding experiences of the family justice system
Where: unstated
When: 2023-8-24
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding two Research Fellows to conduct research using the newly available Ministry of Justice (MoJ) Data First family court â Cafcass linked dataset. Their research, taking place over 15 months, will generate new insights about children and familiesâ experiences of the family justice system.
The Data First family court â Cafcass linked dataset originates from a data sharing agreement between the Secure Anonymised Information Linkage (SAIL) Databank (an ADR Wales partner), MoJ, and Cafcass as a result of the Data First programme. Cafcass stands for Children and Court Family Advisory Service. All data is de-identified. It contains information on marriage and divorce characteristics, adoption, and public and private law cases and their legal outcomes in England and Wales.
The two Research Fellows will be the first to use these linked datasets for policy-relevant research for the public good. Projects are aligned with the MoJ Areas of Research Interest 2020. They will access the data via the SAIL Databank, a trusted research environment available to accredited researchers for approved research projects.
Learn more about the Research Fellows and their projects below.
Dr Ludivine Garside
Source -
Support for development of Longitudinal Education Outcomes (LEO) data — unknown...
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Support for development of Longitudinal Education Outcomes (LEO) data
Where: unstated
When: 2023-8-21
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The Department for Educationâs Longitudinal Education Outcomes dataset provides transformational insights about pathways within and beyond education in England. Linking together administrative data from education, social care, and the labour market, it enables researchers to study peopleâs journeys through childhood and into adulthood. Its purpose is to enhance the life chances of current and future learners through improvement of the evidence base available to central and local government, the broader education system, and the public.
The Department for Education (DfE) makes a subset of its LEO and education data (which focusses on people that have been in education in England) available to external researchers through the Office for National Statistics (ONS) Secure Research Service. It is continually being developed with new data sources being linked in, which extends the opportunities to gain new insights to address important policy questions. However, the dataset is already vast and highly complex, and will become more so as new data is added. It contains information from a wide range of disparate sources, with huge numbers of variables and covers a long period of time. Researchers require a high degree of knowledge and skill to be able to understand, access and use the data.
More valuable insights can be extracted from the data more quickly and more effectively if the âskill-barâ to work with the LEO data can be reduced, increasing the public value of the data.
This grant will enable Dr Claire Crawford from the UCL Centre for Education Policy & Equalising Opportunities (CEPEO) and a small team of researchers from CEPEO, the University of Warwick and the Institute for Fiscal Studies to work in partnership with the LEO Programme team in the Department for Education to help develop the LEO external access offer. This will encompass both the existing LEO via ONS Secure Research Service data and new data developments in the pipeline, with a particular focus on producing supporting materials for the linkages to the Inter-Departmental Business Register (IDBR) data and the Universities and Colleges Admissions Service (UCAS) data. Their support will enable DfE to make faster progress in reducing the LEO âskill-barâ and in increasing consistency and reusability of LEO data.
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Scottish Historic Population Platform (SHiPP) — unknown...
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Scottish Historic Population Platform (SHiPP)
Where: unstated
When: 2023-8-11
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to create a research-ready database based on Scottish civil registration certificates of births, deaths, and marriages from 1855 to 1973.
The research team will develop and apply novel linkage techniques to link these historical certificates, reconstructing individualsâ life courses and generating family pedigrees (diagrams that show family histories). They will also link these certificates to the National Records for Scotland Population Spine, thereby allowing linkage to other administrative datasets. The resulting database will be called the Scottish Historic Population Platform (SHiPP).
The SHiPP database will be the first of its kind in the UK. It will be comparable to databases already established in Scandinavia and beyond. These include the Swedish Demographic Data Base, the Norwegian Historical Population Registers, the Historical Sample of the Netherlands, and the Utah Population Database.
The construction of the SHiPP database will allow historical longitudinal demographic research to be carried out at the individual level. It will additionally enable researchers to analyse multiple generations of micro-data, exploring the condition of the present Scottish population within the context of their families.
Source -
Feasibility Study to Assess the Recording of Endocrine Therapy Use and Induced Vasomotor Symptoms among Women with Breast Cancer in the UK — Joehl Nguyen ...
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Feasibility Study to Assess the Recording of Endocrine Therapy Use and Induced Vasomotor Symptoms among Women with Breast Cancer in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-21
Organisations:
Joehl Nguyen - Chief Investigator - Bayer U.S. LLC
Joehl Nguyen - Corresponding Applicant - Bayer U.S. LLC
Carina Dinkel-Keuthage - Collaborator - Bayer AG
Eren Elci - Collaborator - Bayer AG
Victoria Banks - Collaborator - Bayer AG
Yik Ming Fung - Collaborator - Bayer AGOutcomes:
Induced vasomotor symptoms; vasomotor symptoms; menopause, recording of endocrine therapy use; breast cancer recurrence
Description: Lay Summary
Endocrine therapy intended to reduce recurrence in women with breast cancer is also associated with side effects such as vasomotor symptoms (VMS), commonly known as hot flashes. These symptoms can affect whether patients remain on therapy intended to treat their underlying breast cancer and impact healthcare resource utilization, costs, and cancer outcomes. Evidence is lacking on the association of VMS from endocrine therapy and whether patients stop, remain, or experience other treatment changes.
This study will examine the feasibility of conducting a cohort study in CPRD in women with breast cancer treated with endocrine therapy and have subsequent VMS. The feasibility will examine how well VMS are captured in the CPRD database and assess how endocrine therapy use is captured with respect to documenting whether patients stay on treatment, stop treatment, or experience changes such as reducing amount prescribed.
As this study uses electronic health record data, there may be different ways to determine whether patients experience VMS beyond a recorded diagnosis, such as being prescribed recommended treatments for menopause. The feasibility will also assess if VMS can be defined using a combination of diagnoses and prescription records. Finally, the feasibility will examine how well breast cancer recurrence can be determined in the database.
The findings of the feasibility will determine whether CPRD has adequate data to conduct a full study to investigate the impact of VMS on breast cancer patients continuing endocrine therapy, as well as the impact on healthcare use, costs, and cancer outcomes.
Technical SummaryEvidence is lacking on the impact of vasomotor symptoms (VMS) in women with breast cancer (BC) in the UK primary care setting who start endocrine therapy (ET), which includes tamoxifen, aromatase inhibitors (AI), and gonadotropin releasing hormone (GnRH) analogs. This study will examine the feasibility of a cohort study on women with BC who have VMS after starting ET.
The aim of the feasibility is to determine how well VMS is defined in the CPRD database and different operational definitions for VMS including a combination of diagnosis and prescription records. Second, the feasibility will examine how ET prescriptions are captured, to inform algorithmic considerations for defining treatment outcomes such as adherence, persistence, and dose changes. Finally, the feasibility will examine how well breast cancer recurrence can be operationalized in the database.
The study population will meet the following criteria:
1. Adult female patients with at least one drug exposure to adjuvant ET (tamoxifen, AI, GnRH analogs)
2. BC diagnosis at any time before first ET exposureThe feasibility will assess in the study population:
1. Patient counts, baseline characteristics of those with and without VMS diagnosis
2. Patient counts with recommended VMS treatments such as hormone therapy, serotonin reuptake inhibitors (SSRIs), by VMS status
3. Drug Issue data for ET, hormone therapy, SSRIs: Data completeness, average quantities, average durations, dosing information, route of administration, data transformations needed for adherence, persistence, and dose change measures.
4. Patient counts with BC recurrence or second BC diagnosis during the study period, and temporality of BC recurrence relative to initial diagnosis, ET start, and VMSThe intended public health benefit of this research in a future study is to highlight for women with breast cancer and physicians on the association of VMS on long term ET use and subsequent adverse breast cancer outcomes.
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Treatment Patterns in Dermatomyositis Patients in the UK: A Cohort Study using Clinical Practice Research Data Link (CPRD) — Kristin Moy ...
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Treatment Patterns in Dermatomyositis Patients in the UK: A Cohort Study using Clinical Practice Research Data Link (CPRD)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-30
Organisations:
Kristin Moy - Chief Investigator - Alexion Pharmaceuticals, Inc ( USA )
Daniel Carey - Corresponding Applicant - Alexion Pharma International Operations Limited (Ireland)
Tony Chuang Liu - Collaborator - Alexion Pharma GmbH ( Switzerland )Outcomes:
1) Characteristics of defined DM patients, specifically body mass (Kg);
2) Medical therapies: (i) Time to initiation of a specific DM treatment will be defined as the time interval between the date of index DM diagnosis and start date of the treatment of interest; (ii) Time to treatment switch will be defined as the time interval from initiation of treatment of interest to treatment switch (first treatment had to be discontinued for the switch to appear); (iii) Time to add-on will be defined as the time interval from the initiation of treatment of interest to the treatment add-on (treatment initiated >30 days from the start of the first treatment and overlapped with another treatment); (iv) Time to treatment discontinuation will be defined as the time interval from treatment initiation to discontinuation.Description: Lay Summary
Dermatomyositis (DM) is a rare, chronic disorder of the muscles and skin. It leads to moderate to severe muscle weakness along with inflammation of the muscle; it is also associated with a severe rash that can occur on the hands, face, trunk, knees or elbows. It is commonly diagnosed with blood tests for muscle function, muscle tissue samples, and measurements of electrical activity in the muscle. Current treatments for DM are limited and often aim to manage disease symptoms. Due to the widely varying symptoms between DM patients, typical patterns of treatment are not well understood. For instance, patients may be prescribed steroid medications, immunosuppressants, or other therapies to manage pain or symptom burden. These therapies may occur in differing orders across patients. The primary goal of this study is to chart out the major treatment patterns within DM patients in the UK. This will enable a more detailed understanding of the current therapies in use, together with the therapy journey that patients undertake. This is expected to confer a public health benefit by establishing the typical treatment pathways available to patients. In turn, this may enable greater transparency for both patients and researchers in understanding how DM is managed in primary care settings.
Technical SummaryDermatomyositis (DM) is a rare, chronic inflammatory myopathy, associated with severe weakness of trunk and limb muscles, together with a heliotrope rash. Existing treatments are palliative and seek to restore activities of daily living. The heterogenous symptoms of DM can lead to diverging treatment pathways across patients; currently, major lines of therapy are not well understood. The aim of this study is to characterise treatment patterns amongst DM patients in the UK. The study population will be primary care patients within the UK, registered with a GP practice on or before January 1st 2009 and with a DM diagnosis recorded during the period January 1st 2010 to December 31st 2022. This is an observational, retrospective cohort study using data collected from primary care, via patient encounters with their GP. Data sources for the study will be CPRD Gold and CPRD Aurum â no data linkage will be performed. Descriptive analyses (specifically, lines of therapy analysis, reporting Ns and percentages of patients falling within each therapy line over time, and visualised with Sankey plots) will be applied to understand the treatment pathways of the study population. No inferential testing or statistical modelling will be performed. The intended public health benefit of the study will be to help better establish the typical clinical treatment journeys for DM patients; this may be of benefit in the development of future therapy lines, to assist with situating new therapies in clinical treatment regimen.
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The risk of adverse psychiatric and somatic outcomes with gabapentinoid use: a UK population-based study using electronic health records — Kenneth Man ...
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The risk of adverse psychiatric and somatic outcomes with gabapentinoid use: a UK population-based study using electronic health records
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-09
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Siu Chung Andrew Yuen - Corresponding Applicant - UCL School Of Pharmacy
Joseph Hayes - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )Outcomes:
Primary outcomes: Suicidal behaviour; Unintentional overdoses; Head/body injuries; Road traffic accidents; Hyperglycaemic event; Hypoglycaemic event; major cardiovascular events (acute coronary syndrome, stroke and myocardial infarction); Arrhythmias; Hypertension; Pulmonary Circulation Disorder
Secondary outcomes: Delirium; Respiratory failure; Asthma; Respiratory Tract Infection
Exploratory outcomes: Bleeding; Hypothyroidism; Fluid and electrolyte disorders; Peptic ulcer; Acute kidney injury; Episode of Hospitalisation
(Appendix 7-27)
Description: Lay Summary
Gabapentinoids are a class of medications originally developed to treat seizures. They are now also given to patients for different conditions, including nerve pain, mental illnesses and sleeping problems. Yet, we do not know much about their safety of use. Many people taking them are also on other drugs that could affect their safety profile. There is a knowledge gap for us to find out more about the safety related to the use of gabapentinoids.
The proposed study will study how taking gabapentinoids affects people's mental and physical health. We will compare the number of cases of mental and physical outcomes when people take gabapentinoids with the time when they don't. We will look at how the safety profile differs between the two major gabapentinoids, gabapentin and pregabalin. We will also look at whether other medical conditions such as mental illnesses, diabetes or heart diseases will affect the risk of the outcomes.
We will follow a large group of people who have taken gabapentinoids between 2000 and 2022. The study will investigate the cases of mental and physical outcomes with data from the CPRD. We hope that this study will help understand more about the safety profile related to the use of gabapentinoids. Given the increasing consumption of gabapentinoids in the UK and rest of the world, this study will have important policy, clinical, and public health implications. Doctors and patients will also be able to make better decisions about this class of medication.
Technical SummaryGabapentinoids, such as gabapentin and pregabalin, exert their clinical effects by inhibiting neuronal voltage-gated calcium channel currents. This occurs through impairment of the trafficking function of the α2δ subunits, which leads to a reduction in neurotransmitter release between synapses in the brain. Voltage-gated calcium channels are involved in various physiological functions throughout the body, including synaptic transmission in the central nervous system, smooth muscle contraction in the cardiovascular system, and hormone secretion in endocrine cells. With their pharmacological actions, the consumption of gabapentinoids may have effects beyond the central nervous system, impacting multiple body systems.
Our study will utilize a population-based self-controlled case series design, including individuals aged 18 or above who have received at least one prescription for gabapentinoids in the CPRD database between 1st January, 2000 and 31st December, 2022. The primary objective of our study is to compare the risk of psychiatric and somatic outcomes among patients who have been treated with gabapentinoids during periods of exposure to the medication versus unexposed periods. To compare the risks between gabapentin and pregabalin, a cohort study with propensity score matching will also be conducted.
Our analysis will involve estimating the incidence rate ratios (IRRs) using conditional Poisson regression. In addition, we will calculate adjusted IRRs along with their corresponding 95% confidence intervals to account for potential confounding factors. We will assess the overall exposure as well as examine predetermined exposure risk periods separately.
In our subgroup analysis, we will focus on patients with mental illnesses, type 2 diabetes, or cardiovascular diseases. We will also investigate whether the incidence rates ratios of the outcomes of interest differ when patients were prescribed with specific neuropsychiatric medications concomitantly.
Source -
Adverse health outcomes among people with atopic eczema: a consistent application of cohort study design to multiple outcomes — Julian Matthewman ...
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Adverse health outcomes among people with atopic eczema: a consistent application of cohort study design to multiple outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-09
Organisations:
Julian Matthewman - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Julian Matthewman - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anna Schober - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Anna Schultze - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jennifer Banks - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Asthma; Food allergies; Allergic rhinitis; Allergic conjunctivitis; Eosinophilic esophagitis; Alopecia areata; Urticaria; Depression; Anxiety; Alcohol abuse; ADHD; Autism spectrum disorders; Hypertension; Coronary artery disease; Peripheral artery disease; Myocardial infarction; Stroke; Congestive heart failure; Thromboembolic diseases; Obesity; Diabetes; Metabolic syndrome; Bone fractures; Osteoporosis; Skin infections; Cancer; Dementia; Abdominal Hernia; Alcoholic Liver Disease; Anal Fissure; Angiodysplasia of colon; Anorectal Fistula; Anorectal Prolapse; Appendicitis; Autoimmune liver disease; Barrett's Oesophagus; Cholangitis; Cholecystitis; Cholelithiasis; Cirrhosis; Coeliac Disease; Crohnâs Disease; Diaphragmatic Hernia; Diverticular Disease; Fatty Liver; Gastritis; Gastro-oesophageal Reflux Disease; Irritable Bowel Syndrome; Oesophageal Ulcer; Oesophageal Varices; Pancreatitis; Peptic Ulcer; Peritonitis; Portal Hypertension; Ulcerative Colitis; Volvulus; Bell's Palsy; Cerebral Palsy; Epilepsy; Essential Tremor; Intracranial Hypertension; Migraine; Motor Neurone Disease; Multiple Sclerosis; Myasthenia Gravis; Parkinson's Disease; Peripheral Neuropathy; Trigeminal Neuralgia; Herpes Zoster & Post-herpetic Neuralgia
Description: Lay Summary
Eczema, an itchy skin disease that is common in both children and adults, may increase the risk of developing other health problems. The research on this topic has shown potential links with a number of diseases, such as asthma, heart disease, broken bones, and others, but for many of these researchers are only moderately certain, or uncertain, that links with eczema actually exist. Data from general practice in the UK is suitable to perform studies on this topic, as they contain information about many different diseases from millions of people, but so far researchers have mostly studied one disease at a time, e.g. does eczema increase the risk of breaking a bone, having an issue with the heart, or getting a skin infection. Each of these investigations is costly in time and money and results may not be directly comparable to another. With this project we will systematically and consistently study diseases linked to eczema which has many advantages in terms of cost, efficiency and trustworthiness of results. This leap in efficiency can be achieved by reducing unnecessary differences between individual studies, while still allowing us to input clinical knowledge and expertise. This will allow us to efficiently update our knowledge on the topic and increase how certain we can be about links between eczema and other diseases, making it easier for doctors and public health decision makers to implement better standards of preventive care and increasing the awareness of risks people with eczema may face.
Technical SummaryEczema may be related to a number of adverse health outcomes, however for most outcomes there is only low/moderate certainty evidence, some outcomes may be unknown, and studies employed heterogenous approaches to study design, analysis and data management, making results difficult to compare. Uncertainties should be addressed to improve patient management including implementing screening and preventive measures. Population-based cohort studies using longitudinal routinely collected data are well suited for exploring adverse health outcomes however their conduct one outcome at a time is inefficient. Conducting these studies within a research pipeline minimising unnecessary heterogeneity between studies, while preserving the ability to incorporate the required expert knowledge and critical thinking, will efficiently and quickly allow us to generate evidence on multiple important health-related questions, with a higher level of clinical relevance due to comparability between outcomes.
We will develop a matched cohort research pipeline, fitting multiple adjusted (for age, sex, deprivation, smoking, BMI, oral corticosteroids, outcomes at baseline) Cox models to estimate hazard ratios for each outcome comparing people with eczema to people without. We will examine different age-groups (any age, >=18, >40) depending on the outcome under investigation, and perform multiple sensitivity analyses varying study time-frames, matching strategy, and using CPRD Aurum without HES. We will assess the role of eczema severity in secondary analyses.
Using this pipeline, we will explore associations between eczema and previously explored and unexplored adverse health outcomes. The choice of outcomes will be guided by findings from a recent large-scale review of the previous evidence. We will use CPRD Aurum linked to Hospital Episode Statistics, ONS death registration records and Index of multiple deprivation data. Thus, we will create a high-quality evidence source on adverse health outcomes associated with eczema while describing an approach adaptable to other skin diseases and other areas of research.
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The efficacy and safety of concomitant treatment with candesartan and indapamide in patients with essential arterial hypertension: Outcomes in real world practice — Christopher Morgan ...
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The efficacy and safety of concomitant treatment with candesartan and indapamide in patients with essential arterial hypertension: Outcomes in real world practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-04
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Irena Orel - Collaborator - Krka - Slovenia
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Redenšek Trampuž - Collaborator - Krka - Slovenia
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Systolic blood pressure change, diastolic blood pressure change, adverse events.
Description: Lay Summary
Hypertension (high blood pressure) affects approximately one third of the population and is associated with a range of serious conditions including heart attacks, strokes and kidney disease. It is therefore important to keep blood pressure within normal levels. Usually, patients with hypertension will be asked to make lifestyle changes but if their blood pressure remains high, they may be prescribed a blood pressure lowering drug. If this drug alone fails to reduce blood pressure to a target level, an additional, different type of blood pressure lowering drug may be prescribed. However, taking multiple tablets can be burdensome for patients and there is evidence that if they can be combined in a single tablet, they will be more effective as it is easier for patients to remember to take them. We want to examine the efficacy and safety of taking candesartan (a type of drug known as an angiotensin receptor blocker) and indapamide (a type of drug known as a diuretic) in combination. Patients with a diagnosis of hypertension prescribed either drug who have the other added to their prescription will be selected in the Clinical Practice Research Datalink. Their blood pressure at the time they begin taking the two drugs together will be extracted, evaluated and compared to subsequent measurements recorded at 30â150 days and 90â270 days. Side effects recorded in the first year after starting the combined treatment will also be extracted and evaluated. This will provide important data which will inform drug development and hence improve patient outcomes
Technical SummaryHypertension affects approximately 30% of the UK population and features in the aetiology of a range of conditions. This study aims to evaluate the efficacy and safety of concomitant treatment with two anti-hypertensives, candesartan and indapamide.. A retrospective cohort study will be conducted in the Clinical Practice Research Datalink Aurum and GOLD databases. Patients with essential arterial hypertension prescribed candesartan or indapamide at a stable dose followed by augmentation of the other monocomponent will be selected. The combination of candesartan in two different strengths and indapamide will be presented separately. The index date will be defined as the date that candesartan and indapamide are prescribed in combination. Other antihypertensive agents can be prescribed concomitantly provided they are not initiated or modified less than one month prior to the index date. Patients with secondary hypertension will be excluded. Blood pressure measurements at baseline and checkpoints 1 and 2 will be compared using the dependent t test or paired sample Wilcoxon signed ranks test depending on the distribution. Between groups comparisons will use the independent t-tests (or Mann-Whitney U test) for two groups or ANOVA (or Kruskal-Wallis tests) if there are more than two The proportion of patients reaching targets will be reported. The incidence of safety events will be reported in the year post index and compared to a reference group whose antihypertensive therapy (candesartan or indapamide) is augmented with a different antihypertensive agent. This study will provide valuable data that will assist in the potential development of a fixed dosed combination therapy. There is evidence that combined therapy improves patient compliance and hence both short term and long term outcomes with ultimate efficiencies for health services.
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Understanding and addressing socio-economic inequality within the quality and safety of care and outcomes for people living with dementia. — Evangelos Kontopantelis ...
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Understanding and addressing socio-economic inequality within the quality and safety of care and outcomes for people living with dementia.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-16
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Charlotte Morris - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Louise Robinson - Collaborator - Newcastle University
Patrick Burch - Collaborator - University of Manchester
Pearl Mok - Collaborator - University of Manchester
Tom Blakeman - Collaborator - University of ManchesterOutcomes:
This study has multiple outcomes, which will be examined for their variation with indices of multiple deprivation measures. The outcomes which will be examined are split into 2 areas, âcare processesâ including healthcare utilisation factors, and âkey adverse clinical outcomesâ.
⢠Care processes: Frequency of dementia care reviews; anticholinergic medication burden; potentially inappropriate prescribing rates (including inappropriate polypharmacy); antipsychotic use; medication review within 6 weeks of commencing an antipsychotic; medication review; appropriate anti-dementia medication prescribing; advance care planning; continuity of care measures; carer type; carer review and referrals to social prescribing, social care referrals and safeguarding referrals.
⢠Healthcare utilisation factors: frequency of attendance, missed appointments, modes of consultation, clinical team member performing the care process and place of care provision will be explored for variation with IMD.
⢠Key adverse clinical outcomes: All-cause mortality; unscheduled hospital admissions; delirium; falls; fractures.Appendix 1 details the code-list that will be used to determine dementia diagnosis. During work on the study, these will be refined through review by the research team, including 2 clinicians with a third reviewing if consensus is not achieved about inclusion or exclusion of a code.
Detailed explanation of outcomes
1. Care processes
⢠Frequency of dementia care reviews â the number of dementia care reviews participants receive. Guidance suggests that these should be at least annual (Detailed in code-list - appendix 2).
⢠Anticholinergic medication burden â any prescription of medications with a medium/high anticholinergic activity (code-list - appendix 3). These are not recommended for people with dementia as they can worsen cognition, and prescription of these medications may represent evidence of potentially inappropriate prescribing. This outcome aims to explore how anti-cholinergic drug prescribing varies with index of multiple deprivation for people with dementia .
⢠Antipsychotic use â any prescription of an anti-psychotic medication (code-list - appendix 4). There are specific situations where these are recommended for people with dementia, but in general should be avoided. Long term use, (>6 weeks) especially without review, may represent potentially inappropriate prescribing.
⢠Appropriate anti-dementia medication prescribing â (code-list -appendix 5, drugs solely indicated in dementia from the British National Formulary). Guidance suggests that eligible people should be prescribed appropriate anti-dementia medications. Most people with a diagnosis of dementia should be on at least on anti-dementia medication. The goal of this aspect of study is to investigate if prescribing of these medications varies with IMD, as such we will explore variation of prescribing with IMD, and establish if people in IMD quintiles are less likely to be prescribed anti-dementia medication, which has been found in other work(19).
⢠Medication review â a structured medication review completed by a healthcare professional (code-list- appendix 6). Guidance suggests this should be at least annual.
⢠Potentially inappropriate prescribing â prescribing of medications not recommended in dementia, as described above (code-lists - appendices 3,4,7).
⢠Advance care planning â a structured advance care plan completed by a healthcare professional and coded (codelist- appendix 2). This should be done for every person with dementia, ideally soon after diagnosis.
⢠Continuity of care measures: these will be calculated using the Usual Provider of Care Index (UPC), which is a commonly used measure of continuity of the proportion of patientâs contacts with their most frequently seen GP(10).
⢠Carer review- documented review of the carer of a person with dementia within the clinical record (code-list â Appendix 8). This should happen at every dementia care plan review.
⢠Referral to social prescriber, social services and safeguarding services: we will explore whether or not these referrals are made, and how referral rates vary with IMD quintile. Appendix 9 provides examples of the codes we will use to determine this outcome.2. Healthcare utilisation factors:
⢠Frequency of attendance â number of appointments per year.
⢠Missed appointments â number of missed appointments per year (preliminary code-list - appendix 10)
⢠modes of consultation (face-to-face, telephone, home visit, care home visit)
⢠clinical team member performing the care process (GP, nurse, physiotherapist, ACP/PA, paramedic, pharmacist, healthcare assistant, etc other)
⢠place of care provision â GP surgery, out of hours clinic, home visit.3.Key adverse clinical outcomes:
⢠All-cause mortality
⢠Unscheduled hospital admissions â this will be determined using the linked data requested from HES)
⢠Delirium- any episode of delirium documented during the study (code-list - Appendix 11)
⢠Falls â any fall sustained during the time of the study (Appendix 12)
⢠Fractures â any fracture sustained during the time of the study (Appendix 13)Description: Lay Summary
In coming years, many more people will develop dementia (memory problems affecting day-to-day life). It is recommended that after diagnosis, care for people with dementia should mainly be provided in the community by GP practice teams. There are recommendations for care that should be provided, ensuring it is high-quality and safe. However, few studies have looked at how recommended care and key outcomes, vary with deprivation levels for people with dementia. The studyâs aim is to explore how care and outcomes after a dementia diagnosis vary with deprivation levels and other markers of health disadvantage.
Data from the Clinical Practice Research Datalink (CPRD Aurum) containing anonymised records for people with dementia, aged 18 years or older, diagnosed from 2006 onwards will be included.
We will analyse how âcare processesâ (including yearly reviews, carer reviews, care planning, medication prescribing) and âoutcomesâ (including emergency hospital admissions, falls, fractures) vary with deprivation levels and other markers of health disadvantage. The analysis explore how care varies with deprivation levels, measured by the Index of Multiple Deprivation (which summarises the level of deprivation of where the patients live), as well as other markers of health disadvantage including ethnicity, sex, rural/urban practice location and disabilities.
The results will evidence how care provided and important outcomes for people with dementia vary with the described factors. Results will contribute to guidelines of care and ongoing research designing a program delivering primary care for people with dementia.
Technical SummaryBackground: Global guidance suggests post-diagnostic dementia care should be primary-care led. There is evidence of socioeconomic gradients in dementia care/outcomes, in terms of anti-dementia medication prescribing, and mortality. Previous work identified inequalities in commissioned services. Less research has examined how recommended care processes and key clinical outcomes vary with socioeconomic factors.
Aim: To examine variations with socio-economic factors in the quality and safety of post-diagnosis primary care and outcomes for people with dementia.
Methods: Population-based retrospective cohort study within the Clinical Practice Research Datalink Aurum. Patients aged â¥18 years, with dementia of any type diagnosed between 1/1/2006 and 31/12/2022 will be followed up until death, last data collection, end of study (31/12/2022), or transfer out of practice.
We will examine how care processes and outcomes for people with dementia vary with socio-economic factors. These factors will include the patientâs socioeconomic status as measured by the Index of Multiple Deprivation as well as other markers of health disadvantage including ethnicity, sex, rural/urban practice location and disabilities. Processes examined will include frequency of dementia care reviews, potentially hazardous prescribing, care planning, continuity of care, carer review and social prescribing. Outcomes examined will include delirium, falls, fractures, and unscheduled hospital admissions. Using Poisson regression, variation will be examined by IMD quintile, with other markers of health disadvantage including sex, ethnicity, urban/rural practice classification and disabilities as covariates within the model separately for each care process and outcome. Separate analyses will be completed at 1, 5, and 10 years post-diagnosis.
Impact: This work will examine the variation of care processes and outcomes for people with dementia with IMD and other factors associated with health disadvantage as described above. Results will integrate into ongoing work developing a model of primary care for people with dementia, specifically contributing information about inequalities in existing care and outcomes.
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The association between hyperglycaemia and hypertension during pregnancy and their impact on maternal health and birth outcomes- a retrospective cohort study in the CPRD database — Bee Tan ...
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The association between hyperglycaemia and hypertension during pregnancy and their impact on maternal health and birth outcomes- a retrospective cohort study in the CPRD database
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-09
Organisations:
Bee Tan - Chief Investigator - University of Leicester
Bee Tan - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Elpida Vounzoulaki - Collaborator - University of Leicester
Evgeny Mirkes - Collaborator - University of Leicester
Jiamiao Hu - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
⢠Annual incidence of hyperglycaemia and hypertension complicated pregnancy since 2000;
⢠Association of co-occurrence of hyperglycaemia and hypertension complicated pregnancy with possible determinants such as age, body mass index (BMI), ethnicity, smoking status, alcohol intake, geographic area, PCOS, and COVID-19 infection;
⢠Reproductive and birth outcomes include: birth weight (both LGA and SGA); rate of C-section, preterm birth, stillbirth, birth trauma, as well as postpartum depression;
⢠Long-term metabolic outcomes in the mothers include: postpartum obesity, diabetes, hypertension, cardiomyopathy, chronic kidney disease and non-alcoholic fatty liver disease.
Description: Lay Summary
High blood pressure and high blood sugar levels are becoming more and more common in pregnancy due to the increasing age of mothers and the increases in obesity rates among mothers.
High blood pressure increases the risk of pregnancy problems such as baby dying in the womb, and small babies. On the other hand, high blood sugar levels increases the risk of high blood pressure during pregnancy and big babies.
Both high blood pressure and high blood sugar levels in the mother during pregnancy increases the risk of women and their babies to the development of overweight, high blood pressure and high blood sugar levels later in life.
It still not fully understood that how the combination of high blood pressure and high blood sugar levels affect both mothers and her babies during pregnancy as well as after birth.
This study aims to find out how high blood pressure and/or high blood sugar levels during pregnancy could affect pregnancy results and long-term health of the mother. Our findings may provide new knowledge for improving the pregnancy care, finding out women at risk and providing timely treatment to decrease pregnancy problems.
Technical SummaryThis study aims to estimate the incidence of women who were diagnosed with both hyperglycaemic and hypertensive disorders during their pregnancy; and recognise potential risk factors for the co-occurrence of these two disorders. Additionally, we will also investigate the potential impacts of these two disorders together on reproductive and birth outcomes for both mothers and offspring.
The cohort will include patients with both antenatal check-ups and maternity records between 01/01/2000 to latest release. The trends in the incidence of co-occurrence of both hyperglycaemia and hypertensive disorders among pregnancies will be evaluated firstly. This incidence number will also be compared to the theoretical probability of co-occurrence (if these two disorders are independent) to assess the association between with hyperglycaemia and hypertension during pregnancy.
Determinants of potential risk factors such as age, body mass index (BMI), ethnicity, other pregnancy complications, ethnicity, smoking status, deprivation index, mental health and geographic area, PCOS, COVID-19 infection, etc. will be extracted based on the information available within CPRD-HES data. And we will use multivariate logistic regression models to estimate the association of these factors to co-occurrence of both disorders.
All missing data will be addressed through complete-case analysis, with a sensitivity analysis carried out using multiple imputation to address missing data.
This study will provide novel and inclusive information about the possible predisposition to these two common pregnancy disorders (hyperglycaemic and hypertensive disorders during pregnancy), and their impacts on maternal and offspring health, which will aid clinicians and healthcare professionals in improving the quality of provided health services.
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Chronic pain and opioid prescribing in the local health economy: the trends in prevalence and incidence and associated healthcare resource utilisation — Leah Fisher ...
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Chronic pain and opioid prescribing in the local health economy: the trends in prevalence and incidence and associated healthcare resource utilisation
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-15
Organisations:
Leah Fisher - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
catherine alexander - Collaborator - Helping Health Ltd
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient characteristics; Prevalence trends; Incidence trends; Healthcare resource use; Prescription trends and costs; general practitioner contacts and costs; Inpatient admissions and costs; Outpatient visits and costs; Accident and Emergency visits and costs.
Description: Lay Summary
Chronic pain is defined as a pain that lasts for longer than 12 weeks. Often patients with chronic pain are treated with drugs known as opioids. However, opioids are known to have side effects such as nausea and constipation and can lead to dependency and both fatal and non-fatal overdoses. Whilst opioids undoubtedly have a role in pain management, there have been several initiatives aimed at reducing inappropriate use. Determining the most important influences on prescribing opioids for chronic pain may play an important role in changing the prescribing behaviour of general practitioners and reduce opioid prescription. The purpose of this study is to analyse trends in the prescribing of opioids and its associated healthcare resource utilisation and cost within different regions of England. This will provide valuable information about the prescribing trends within local healthcare regions and contribute to implementing alternative action plans and improve the management of chronic pain.
Technical SummaryIncreases in opioid prescriptions have been seen in the UK in recent years, leading to increases in healthcare resource utilisation and associated costs as well as concerns over the addiction and misuse of the drug. We aim to profile the diagnosis of chronic pain and the prescribing of weak, strong and non-opioids in England from 2010â2020 and examine the healthcare resource use and associated cost. Acceptable patients linked to the HES admitted patient care (APC), outpatient and accident and emergency datasets will be selected from the CPRD Aurum dataset if they have a medical code indicative of chronic pain and/or a product code indicative of analgesic prescription. The annual incidence and prevalence of chronic pain will be reported for each Office of National Statistics (ONS) region, and will be stratified for strong, weak and non-opioid prescription . Healthcare resource use in primary and secondary care following opioid initiation will be presented and HCRU will be costed using standard tariffs. In addition, characteristics of patients with chronic pain and markers of opioid abuse and addiction will be reported, stratified by opioid strength/non-opioids. This study will provide information on chronic pain and opioid prescribing trends within local healthcare regions, which in turn will contribute to the improvement of the management of chronic pain.
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Changes in survival, and causes of death in people with idiopathic pulmonary fibrosis in England, 2010 to 2022 — Jennifer Quint ...
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Changes in survival, and causes of death in people with idiopathic pulmonary fibrosis in England, 2010 to 2022
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-22
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Rikisha Shah Gupta - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Peter George - Collaborator - Royal Brompton HospitalOutcomes:
Our overall study period is from 1 January 2010 to the end of the available linked data. Our study period will include people who have a new diagnosis of IPF (incident cases). Findings from another study (ISAC protocol 20_000068) will be used to define 4 IPF study cohorts. Outcomes that will be assessed in these 4 IPF study cohorts are
1. Year-on-year survival over the study period
2. Year-on-year all-cause mortality
3. Change in causes of death over the study periodDescription: Lay Summary
Idiopathic pulmonary fibrosis (IPF) is a lung disease where scar tissue forms in the lungs, making it hard to breathe. As the disease progresses, the lung tissue becomes thickened and stiff, making it difficult for oxygen to pass into the bloodstream. The exact cause is still not fully understood, although it is believed to involve a combination of genetic and environmental factors. It primarily affects older adults. Most survive for about three to five years after diagnosis. Treatments, called antifibrotics aim to slow progression and improve quality of life. Despite the seriousness of the condition and poor prognosis until recently there hasnât been much research. Until a decade ago there were no guidelines on how to diagnose Idiopathic Pulmonary Fibrosis. We conducted a prior study to understand how general practitioners (GPs) record Idiopathic Pulmonary Fibrosis and after observing changes in coding practices calculated updated incidence and prevalence . We hope through this study to develop a better understanding of disease survival and assess the impact of treatments on survival. We will used linked primary and secondary care data and mortality data to calculate the mortality rates of people with idiopathic pulmonary fibrosis and see how this has changed over time as well as explore what people with idiopathic pulmonary fibrosis die of and how this has changed over time. This will help us better understand how we can improve survival in this population.
Technical SummaryIdiopathic pulmonary fibrosis (IPF) is a lung disease where scar tissue forms in the lungs, making it hard to breathe. People diagnosed with IPF have a historic median survival of less than 3-5 years from diagnosis. We conducted a prior study to understand how general practitioners (GPs) record IPF (ID number 20_000068) and from this derived four algorithms with varying accuracy from which to determine someone has a diagnosis. These 4 algorithms are: i) individuals with a diagnosis of pulmonary fibrosis of any aetiology (not necessarily IPF diagnosis) in Aurum and a primary or secondary discharge diagnosis of IPF in HES APC, known as âAurum and HESâ ii) individuals with an evidence of at least one clinical code strongly indicative of an IPF diagnosis in Aurum, known as âAurum narrowâ iii) individuals with a diagnosis of pulmonary fibrosis of any aetiology (not necessarily IPF diagnosis) in Aurum (evidence of at least one clinical code with a possible diagnosis of IPF) known as âAurum broadâ and, iv) individuals discharged with a primary or secondary diagnosis of IPF in HES APC, known as âHES APCâ.
In this study, we will use linked Aurum, hospital episode statistics inpatient data (HES APC) Office for national statistics (ONS) mortality data and deprivation data (IMD). We will investigate changes in survival and causes of death over the past 10 years using the definitions from the validation study. Each of the following aims will be assessed:
i) Determine median survival in patients with IPF
ii) Determine year-on-year all-cause mortality
iii) Investigate changes in causes of deathUnderstanding the causes of death and survival over time will better help us understand how these people are currently managed and will inform us whether treatment developments may have had an impact on the IPF field.
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Primary care for care home residents: Changes over time before and through the COVID-19 pandemic — Barbara Hanratty ...
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Primary care for care home residents: Changes over time before and through the COVID-19 pandemic
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-22
Organisations:
Barbara Hanratty - Chief Investigator - Newcastle University
Barbara Hanratty - Corresponding Applicant - Newcastle University
David Sinclair - Collaborator - Newcastle UniversityOutcomes:
All-cause hospitalisation; Admission to Accident and Emergency; Primary care contacts; Number of prescribed items.
Description: Lay Summary
Most people who live in care homes are older adults. Many have several health problems, and need help with daily tasks. Family doctors (general practitioners) look after their day-to-day medical care, working with care home or community nurses. In England, there have been moves to improve healthcare for people in care homes. In this study, we will look at how care home residents use general practice services. We will look at service use at a time when changes were introduced, and during the COVID pandemic. To do this, we will analyse information from electronic healthcare records in primary care, using the CRPD Aurum research database. Findings from this work will tell us how use of primary care by residents has changed over time, and whether number of contacts with primary care staff, prescriptions or referrals to hospital (for example), differ according to the care home workload for each practice. Overall the research will help to understand whether primary care for care home residents seems to be improving, whether it is a good idea for practices to take on many residents, and how things have changed across the pandemic.
Technical SummaryGeneral practice provides front line NHS care for around 400,000 care home residents in the UK. Good care has the potential to optimise health, wellbeing and use of hospital services, but it is difficult to deliver. There have been a number of initiatives in England to improve primary care for care home residents. The NHS England Vanguard funded innovation in services for care homes in five areas (2015-2018), and this led to an England-wide initiative (Enhanced Health in Care Homes) to introduce standardized primary healthcare processes between 2020-2024. The COVID-19 pandemic also heightened awareness of the importance of primary care to care homes, and is likely to have complicated the introduction of changes in ways of working.
The aim of this study is a) to describe selected aspects of primary care services over time in care homes, before and after the introduction of the Enhanced Health in Care Homes Framework, and in the context of the coronavirus pandemic, and b) to identify factors associated with higher levels of health service utilisation by care home residents.
Design: Analysis of primary care data from CPRD Aurum
Participants: Care home residents =>75years, registered with participating practices in CPRD Aurum 2017-2023.
Methods: Comparison of annual consultations, referrals and polypharmacy for residents in different practices, with practices classified by the number of registered patients who are care home residents. Multivariable regression models will investigate individual and practice level factors associated with higher rates of consultation rates and polypharmacy.
Output: This study will draw conclusions on variation in general practice utilization by care home residents, how this changed across the COVID-19 pandemic and introduction of standardized processes, and according to practice care home workload.
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Global COVID Vaccine Safety (GCoVS) Project Investigating COVID-19 Vaccination and Adverse Events, including Myocarditis, Pericarditis, Guillain-Barre Syndrome and Vaccine Induced Thrombosis and Thrombocytopenia: A Self-controlled case series study. — Debabrata Roy ...
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Global COVID Vaccine Safety (GCoVS) Project Investigating COVID-19 Vaccination and Adverse Events, including Myocarditis, Pericarditis, Guillain-Barre Syndrome and Vaccine Induced Thrombosis and Thrombocytopenia: A Self-controlled case series study.
Datasets:GP data, CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-22
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Alison Yeomans - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Denise Morris - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Saad Shakir - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
The primary outcomes for each sub-study are as follows:
⢠Myocarditis and pericarditis,
⢠Guillain-Barre Syndrome,
⢠Vaccine-induced Thrombosis with Thrombocytopenia, Thrombosis with Thrombocytopenia Syndrome. To be considered a possible case, an individual would have to have at least one code for thrombocytopenia and one for thrombosis in the same hospitalisation or health encounter.Please find code lists for each in Appendices 1-4.
Description: Lay Summary
Billions of doses of COVID-19 vaccines have been administered to people across the world, with evidence of good effectiveness and a favourable safety profile. However, rare, and sometimes serious side effects have been reported. It is important to continue to monitor the safety of the COVID-19 vaccines, to support vaccine confidence, to add to available evidence, and to highlight any potential possible reasons for side effects.
This study seeks to evaluate the safety of COVID-19 vaccines, by comparing the frequency of four important side effects. The four conditions to be assessed will be: two forms of inflammation of the heart (Myocarditis and pericarditis), a condition that affects the nervous system (Guillain-Barré Syndrome (GBS)) as well as a new blood clotting condition, known as Vaccine-Induced Thrombosis and Thrombocytopenia (VITT). These four conditions will be compared in vaccinated and unvaccinated individuals. We will investigate possible reasons for the development of myocarditis and pericarditis, GBS, and VITT following COVID-19 vaccination, and will assess the severity of these side effects.
Results of this study will better estimate the risk of myocarditis and pericarditis, GBS, and VITT following COVID-19 vaccination. The results from this study will contribute to a larger European study to allow for larger numbers to be assessed to gain the best possible insight into the reason why these side effects have occurred, that will ultimately improve vaccine safety.
Technical SummaryCOVID-19 vaccinations have a favourable benefit/risk profile, having been rapidly deployed since 2021. However, further investigation of Adverse Events of Special Interest (AESI), including myocarditis, pericarditis, Guillain-Barré Syndrome (GBS), and Vaccine-Induced Thrombosis and Thrombocytopenia (VITT) is warranted.
This study will use a retrospective self-controlled case series design to examine the association of myocarditis and pericarditis, GBS, and VITT with COVID-19 vaccines, comparing the incidence risk of these AESI following COVID-19 vaccination with a control period of no COVID-19 vaccine exposure. The retrospective self-controlled risk interval design will identify risk and control windows surrounding the point of exposure (vaccination), to ensure all cases share the same risk and control periods. Fixed effects Poisson regression will be utilised to evaluate relative incidences for all cases as well as subset analysis by age and sex. To determine the influence of vaccine interval the Pearson correlation coefficient will be determined. Risk factors for myocarditis, pericarditis, GBS, and VITT will be investigated. Clinical characteristics, severity, and prognosis of these events following COVID-19 vaccination will also be examined.
Using CPRD, we will define a cohort of eligible patients who have a recorded code for one of the four AESI included (prior to or following COVID-19 vaccination). Self-controlled risk interval methodology will be utilised to determine whether there is an increased risk of myocarditis, pericarditis, GBS, or VITT following COVID-19 vaccine exposure. Each case will act as their own control, contributing both exposed and unexposed time periods. The results from this CPRD self-controlled case series will be pooled with data from other European sites, to contribute to a wider network study. Results from all sites will be meta-analysed to produce an overall measure of association for each of the four included AESI.
Results of this study will inform vaccine policymakers, immunisation providers, and vaccinees.
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Risk of Osteonecrosis of the Jaw in Female Users of Osteoporosis Treatments — Susan Jick ...
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Risk of Osteonecrosis of the Jaw in Female Users of Osteoporosis Treatments
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-29
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Osteonecrosis (any site); osteonecrosis of the jaw
Description: Lay Summary
More than 2.5 million females in the UK are at risk for fractures caused by weakened bones (osteoporosis) and may benefit from treatment to prevent these fractures from occurring. One serious, but rare, side effect associated with some osteoporosis treatments is osteonecrosis of the jaw, a condition where the bone in the jaw weakens and dies. It is hard to get a good estimate of how often females with osteoporosis experience osteonecrosis of the jaw as the event is rare and there are few specific diagnosis codes for this condition. In a previous study, we evaluated the potential for using CPRD and HES (hospital) data together to create definitions for probable and possible cases of osteonecrosis of the jaw. In this study we will evaluate the risk of probable and possible osteonecrosis of the jaw according to the type of osteoporosis treatment as well as the total amount of osteoporosis drug received. The results of this study, though derived from patients in England and Wales, will be generalizable to the wider United Kingdom patient population and will provide valuable information to patients and clinicians on risk of osteonecrosis of the jaw when deciding between osteoporosis treatments.
Technical SummaryMore than 2.5 million females in the UK are at risk for osteoporotic fractures and may benefit from treatment to prevent these fractures from occurring. Osteonecrosis of the jaw (ONJ) is a known adverse event associated with use of some osteoporosis treatments (bisphosphonates and denosumab). However, little is known about how the risk of ONJ varies between treatments, dose and duration of treatment, and use of concomitant medications. Under RDG # 21_000685, we developed an algorithm for selecting probable and possible cases of ONJ using information present in CPRD and linked HES records. In this study we will match osteonecrosis cases to up to 10 patients without osteonecrosis from the same population of female users of osteoporosis treatments by source (GOLD vs Aurum), age, calendar time and disease severity. We will then use conditional logistic regression to estimate the odds of ONJ by osteoporosis treatment including by cumulative dose, duration, combination treatments and concomitant medications (ie., steroids, hormone replacement therapy, immunosuppressants) compared with the lowest quintile of cumulative dose of alendronate use. The results of this study, though derived from patients in England and Wales, will be generalizable to the wider United Kingdom patient population and will provide valuable information to patients and clinicians on risk of ONJ when deciding between osteoporosis treatments.
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The association between multimorbidity and subsequent dementia: a descriptive cohort study in a representative UK database — Adam Todd ...
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The association between multimorbidity and subsequent dementia: a descriptive cohort study in a representative UK database
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-30
Organisations:
Adam Todd - Chief Investigator - Newcastle University
Hilary Shepherd - Corresponding Applicant - Newcastle University
Andrew Kingston - Collaborator - Newcastle University
Charlotte Richardson - Collaborator - Newcastle University
David Sinclair - Collaborator - Newcastle University
Fiona Matthews - Collaborator - Newcastle UniversityOutcomes:
Primary: first ever diagnosis of dementia
Exploratory: presence of medication review, polypharmacy or deprescribing record in the primary care data
Description: Lay Summary
Multimorbidity refers to the presence of two or more long-term conditions within one person, and our primary aim is to investigate whether multimorbidity is associated with a subsequent dementia diagnosis. Polypharmacy refers to five or more medications being taken simultaneously by one person, and is common in people with multiple health conditions. Polypharmacy is problematic when drugs interact with each other, when medication regimes get too complicated to manage, or when drugs have harmful effects on the body. In such cases, clinicians may conduct medication reviews or deprescribing interventions to streamline a medication regime or reduce the number of drugs a person is taking. Therefore, the secondary aim of this study is to investigate how well deprescribing, medication reviews or polypharmacy are coded in CPRD data and whether presence of these alters the outcome of dementia â either positively or negatively. This study will also investigate whether people from different groups have different experiences i.e., whether there are inequalities present in a patient journey from multimorbidity to dementia. We will consider geographical region, ethnicity, sex and deprivation as possible sources of inequality.
The current study will define multimorbidity as 2 or more of a possible 37 conditions and conduct analyses in a large database which accurately represents the makeup of the UK population (CPRD GOLD). This research will benefit patients in England and Wales by informing reorganisation of services to best treat patients with multimorbidity and adding to the knowledge base of patients with dementia.
Technical SummaryThe primary aim is to investigate whether multimorbidity at a younger age is associated with an earlier subsequent dementia diagnosis. The secondary aim is to investigate how well deprescribing, medication reviews or polypharmacy are coded in CPRD data and, if there are sufficient records, whether presence of these alters the outcome of dementia. This study will also investigate the inequalities in trajectory from multimorbidity to dementia in those with at least 20 years of follow-up, considering geographical region, ethnicity, sex and deprivation. We will use CPRD GOLD primary care data and Index of Multiple Deprivation at practice and patient level, conduct cox proportional hazards models to determine risk of dementia, Fine-Gray models to account for competing risk of death, sensitivity analyses to consider patients with <20 years of follow-up, and describe the patients with multimorbidity who have the greatest risk of dementia.
One recent longitudinal study has shown that multimorbidity at a younger age is more strongly associated with dementia than older ages, however this study considered only 13 multimorbidity conditions and used a population likely to be biased towards healthier participants. The current study will expand the definition of multimorbidity to include 37 conditions and conduct analyses in a large representative sample of the UK general population.
Health systems are increasingly treating patients with multimorbidity yet are structured primarily to treat single diseases. This research will benefit patients in England and Wales by informing existing research into how diseases interact with each other to influence patient outcomes, informing reorganisation of services to best treat patients with multimorbidity, and adding to the knowledge base of patients with dementia.
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Risk of suicide events with discontinuation of antidepressant treatment in patients with major depressive disorder. — Kenneth Man ...
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Risk of suicide events with discontinuation of antidepressant treatment in patients with major depressive disorder.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-04
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Sohee Park - Corresponding Applicant - University College London ( UCL )
Adrienne Chan - Collaborator - UCL School Of PharmacyOutcomes:
The outcome of interest will be suicide events, composite of suicide attempt and completed suicide.
Description: Lay Summary
Depression is a common and recurring mental health condition, affecting around 4 out of 100 people worldwide. People with moderate to severe depression often require treatment with antidepressants. While using antidepressants consistently has been shown to be effective, stopping their use can be challenging and requires careful planning in clinical practice. When treatment is stopped, there is a high risk of depression returning, with suicidal behavior as one early warning sign of relapse. However, understanding the link between stopping antidepressants and suicidal behavior has been challenging in scientific studies because of the serious consequences involved and the limitations of research methods. Since suicidal behavior is rarely reported in clinical trials and is hard to know accurately from individual case reports, we plan to use data from UK primary care to better understand how antidepressants are used, and to answer specific questions about the connection between stopping antidepressants and suicide. This study aims to find the best strategies for maintaining and stopping antidepressants in order to minimise the risk of suicide. This can help reduce the strain on healthcare systems and, on a larger scale, decrease the risk of suicide as well as the emotional and financial costs it brings to individuals, families, and communities.
Technical SummaryWe aim to examine the patterns of antidepressant discontinuation and its impact on suicidal behaviour in the UK by utilising electronic health records from the Clinical Practice Research Datalink (CPRD) spanning 2001 to 2023. The study population consists of individuals with depression receiving their first antidepressant prescription during study period. We will characterise the classes and individual drugs of the initial antidepressant treatment, and evaluate treatment retention by calculating the duration from antidepressants treatment initiation to discontinuation using survival analyses; with separate analyses for individual drugs and classes. We will investigate the duration and modes (gradual taper, switching, or abrupt stopping) of the discontinuation of initial antidepressant treatment. Subsequently, we will conduct self-controlled case series (SCCS) and cohort analysis to investigate the association of suicide events with antidepressant discontinuation. The SCCS analysis will only include individuals who experienced both antidepressant discontinuation and suicide events during the study period. The incidence rate ratio (IRR) will be estimated by comparing incidence rates during different risk periods, including the period shortly after antidepressant discontinuation, using conditional Poisson regression, adjusting for time-varying factors such age, concurrent use of other psychotropic medications and seasonal effects in the analysis. In cohort analysis, we will estimate the risk of suicide during the antidepressant discontinuation period by emulating hypothetical target trial using clone-censor-weight approach. We will then conduct several subgroup and sensitivity analyses to examine the robustness of the main analysis.
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Association between propensity to prescribe antibiotics for common infections in primary care and adverse outcomes — Koen Pouwels ...
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Association between propensity to prescribe antibiotics for common infections in primary care and adverse outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-29
Organisations:
Koen Pouwels - Chief Investigator - University of Oxford
Koen Pouwels - Corresponding Applicant - University of Oxford
David Smith - Collaborator - University of Oxford
Mike Sharland - Collaborator - St George's, University of London
Murong Yang - Collaborator - University of Oxford
Vinh Nam Nguyen - Collaborator - University of Oxford
Yingfen Hsia - Collaborator - UCL School Of PharmacyOutcomes:
The following adverse outcomes, potentially reflective of treatment failure, occurring within 3, 14, and 30 days of the first infection-related GP consultation will be evaluated:
- Another GP consultation
- Another GP consultation with another antibiotic
- Any hospital admission
- Hospital admission with an infection-related diagnostic code
- Hospital outpatient visit
- Emergency department visit
- All-cause death (also evaluated at 90 days)
- Death with an infection-related diagnostic code (also evaluated at 90 days).The primary analysis will focus on events occurring within 30 days for all outcomes, but to enable comparability with other studies the other time points will also be included.1
Description: Lay Summary
Antibiotic resistance poses a growing threat, highlighting the need to optimize antibiotic prescribing in primary care. To establish optimal prescribing levels, understanding the relationship between prescribing decisions and adverse outcomes for common infections is crucial.
This study aims to work out whether variation in antibiotic prescribing is mainly driven by patient factors such as underlying chronic diseases, or due to doctors making different decisions for the same types of patients. Subsequently we will assess the health consequences of these different antibiotic prescribing decisions. Adverse outcomes, reflective of potential treatment failure or side-effects of the antibiotic, occurring within 3, 14, and 30 days of the initial GP visit will be evaluated.
Using various statistical techniques that adjust for differences between patients for which doctors make different antibiotic prescribing decisions, we will estimate the impact of those decisions on patient outcomes, including the need to get another antibiotic, the need to go to the doctor or hospital, or death shortly after the initial visit to the doctor. We expect that going to a high-prescribing practice offers patients no to little benefit in terms of health outcomes.
Overall, this study seeks to inform current discussion around how to optimize antibiotic prescribing by examining variation and assessing relationships with important patient outcomes.
Technical SummaryGiven the increasing threat of antibiotic resistance, there is an increasing recognition that there is a need to optimise antibiotic prescribing in primary care, where the majority of antibiotic prescriptions occur. To establish optimal prescribing levels, a better understanding of variation in antibiotic prescribing and the relationship between different prescribing decisions and the risk of adverse outcomes following common infections is required.
This study will estimate to what extent practice-level variation can be explained by case-mix, by practice-level preference, and by unexplained factors. Subsequently associations between practice-level antibiotic prescribing propensity and the risk of adverse outcomes following common infections will be assessed: bronchitis, cough, otitis media, rhinosinusitis, sore throat, asthma exacerbation, COPD exacerbation, gastroenteritis, impetigo, lower respiratory tract infection, upper respiratory tract infection, and urinary tract infection.
The following adverse outcomes, potentially reflective of treatment failure, occurring within 3, 14, and 30 days of the first infection-related GP consultation will be evaluated: another GP consultation with(out) another antibiotic, any hospital admission, hospital admission with an infection-related diagnostic code, hospital outpatient visit, emergency department visit, any death, death with an infection-related diagnostic code.
We will use a grouped-treatment variables with individual covariates approach to overcome strong confounding by indication. Practice-level antibiotic prescribing propensity will be estimated for each common infection separately, accounting for age, sex, and comorbidities, where the prescribing propensity reflects the percentage of condition-specific consultations that resulted in an antibiotic prescription in each year.
We hypothesise that, after adjusting for case-mix, that the relationships are non-linear, leading to identification of levels of prescribing above which prescribing to more patients has no or negligible benefits. Where potentially valid instrumental variables can be identified, we will also perform instrumental variable analysis to address potential unmeasured confounding.
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The association between prescriptions for inhaled corticosteroids, pneumonia and exacerbations in people with asthma and Chronic obstructive pulmonary disease — Jennifer Quint ...
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The association between prescriptions for inhaled corticosteroids, pneumonia and exacerbations in people with asthma and Chronic obstructive pulmonary disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-08
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Alexander Adamson - Collaborator - Imperial College London
Chin Rong Ong - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College LondonOutcomes:
Pneumonia
Asthma or COPD exacerbationDescription: Lay Summary
Pneumonia is a common respiratory infection, and people with lung diseases such as asthma or chronic obstructive pulmonary disease are at higher risk of pneumonia than the general population. Some treatments that are used to treat chronic obstructive pulmonary disease and asthma, in particular inhaled steroids, may contribute to the increased pneumonia risk. However, these medications are commonly used in both diseases as they help to reduce symptoms and flare ups of the diseases. Previous studies have found mixed results when investigating this topic, this is in part because the definitions used for pneumonia and exacerbations often overlap. Some studies have shown inhaled steroids increased pneumonia risk and others that they do not. We have recently finished a study determining the most accurate way to find pneumonia events in electronic healthcare record data and will use this information to see if people prescribed inhaled steroids with asthma or chronic obstructive pulmonary disease are at increased risk of pneumonia events compared with people not prescribed inhaled steroids.
Technical SummaryPneumonia is common, and people with lung diseases such as asthma or chronic obstructive pulmonary disease (COPD) are at risk of pneumonia. Some treatments that are used to treat COPD and asthma, in particular inhaled corticosteroids (ICS), may contribute to the increased pneumonia risk. Previous studies have found mixed results when using routinely collected electronic healthcare record data, this is in part because the definitions used for pneumonia and exacerbations often overlap. We have recently finished a study determining the most accurate way to find pneumonia events using CPRD Aurum and HES APC (21_000468) and will use this information in addition to previously developed validated definitions to find exacerbation events to see if people prescribed ICS are at increased risk of pneumonia events compared with people not prescribed ICS. We will use a cohort of people with current asthma or COPD between 2010 and 2021 determined from CPRD Aurum. We will use regression models to estimate the association between asthma, or COPD and inhaled corticosteroids (ICS) and community acquired pneumonia (CAP) or exacerbations. We will adjust for multiple potential confounders (including age, gender, smoking, body mass index, disease severity). We will use HES APC data to find pneumonia and exacerbation events, HES A&E to also capture asthma events, IMD data to include socioeconomic status in the models and ONS for pneumonia mortality
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Enhancing Autism Spectrum Disorder (ASD) Research in the United Kingdom: Prevalence Estimation and Comparative Assessment of Conventional Regression and Machine Learning Models for ASD Risk Prediction — Kenneth Man ...
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Enhancing Autism Spectrum Disorder (ASD) Research in the United Kingdom: Prevalence Estimation and Comparative Assessment of Conventional Regression and Machine Learning Models for ASD Risk Prediction
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-10
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Adrienne Chan - Corresponding Applicant - UCL School Of Pharmacy
Ian Wong - Collaborator - University College London ( UCL )Outcomes:
Autism spectrum disorder (ASD) in offspring
Description: Lay Summary
Autism spectrum disorder (ASD) is a condition that affects the development of the brain and can cause difficulties in social interaction, communication, and behaviour. It is becoming more common globally, with approximately one in 160 children worldwide being affected. In the United Kingdom, it is estimated that 0.68% of the population had ASD in 2018. ASD can result in lifelong challenges and other health conditions.
Since there is currently no effective treatment for the main symptoms of ASD, it is crucial to focus on identifying and addressing factors that can increase the risk of developing ASD and related health conditions. Detecting and intervening early is also important to support the progress and functioning of children with ASD. By using information from electronic health records, we can develop strategies that help identify risk factors and individuals who are at a higher risk of ASD and associated health conditions. These strategies will assist in creating interventions to minimize risks and provide early support for individuals with ASD.
Previous studies have examined specific factors that may contribute to the development of ASD, such as maternal risk factors and characteristics of the child. However, it is likely that ASD and associated health conditions result from the combination of multiple factors. Therefore, our study aims to determine the prevalence of ASD in the UK and investigate how different factors interact to influence the development of ASD and associated health conditions.
Technical SummaryThis is a retrospective cohort study using data from the CPRD GOLD and CPRD Aurum databases in the UK. The aim of the study is to first estimate the prevalence of ASD in the UK then to develop and compare the predictive performance of machine learning based models with conventional regression models.
We will first estimate the annual prevalence of clinically diagnosed ASD in the UK. The annual prevalence of ASD will be calculated by summing up the number of people with ASD during each study year in the total population and targeted age and sex groups. The summed number will then be divided by the total number of populations of the targeted age/sex group in the middle (July) of that particular year. The annual prevalence will be expressed per 100 persons with a 95% confidence interval, estimated by Poisson method. A linear regression model will be used to test for time trends in the annual prevalence in average annual percentage change throughout the study period.
Conventional multivariable regression model will be used to develop a risk model to predict ASD. The choice of maternal modifiable risk factors and early childhood characteristics will be derived from the existing influential literature. We will fit a full model with all variables. Penalised logistic and Cox proportional hazards model will then be used to develop a risk model to predict ASD respectively. Machine learning approaches, for example neural networks, XGBoost, XGBoost-surv, random forests, and random survival forests, will be used to develop the ASD prediction algorithm. Results will be used to construct a prognostic index for ASD.
Predictions obtained from the machine learning techniques will be compared to those from the conventional regression approaches using measures such as overall accuracy, sensitivity, specificity, precision, and the area under the receiver operating characteristic curve.
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Exploring the feasibility of CPRD to characterise the health of older people living in poverty — Barbara Hanratty ...
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Exploring the feasibility of CPRD to characterise the health of older people living in poverty
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-30
Organisations:
Barbara Hanratty - Chief Investigator - Newcastle University
David Sinclair - Corresponding Applicant - Newcastle University
Andrew Kingston - Collaborator - Newcastle University
Gemma Spiers - Collaborator - Newcastle University
Laurie Davies - Collaborator - Newcastle UniversityOutcomes:
Work completed from approved protocol
⢠We will look for a record of one or more SNOMED codes associated with material disadvantage, as listed in Appendix A, that have been documented in the patient observation record of Aurum. We will aggregate these codes into a binary material disadvantage variable. We will further explore the feasibility of creating a categorical or score based measure using the nine different domains of material disadvantage (benefits, employment, environment, housing, income, neglect, support service, transport, other).
⢠Secondary outcome: one or more of the long-term conditions specified in Appendix B. Appendix B also includes codes to be used to filter out patients who have a condition that was not long-term. We defined chronic conditions as having a history of the disease, except for non-melanoma skin cancers that werenât infiltrating, and conditions that are typically transient (e.g. diabetes/hypertension/anaemia of pregnancy), or have resolved (for example, children can outgrow asthma and epilepsy).Amended approach
We will look for a record of one or more of the codes associated with material disadvantage,
as listed in Appendix A, that have been documented in the patient observation record of Aurum.
We will aggregate these codes into a binary material disadvantage variable.Description: Lay Summary
Helping people to live longer and in good health is a priority for governments. This goal must be underpinned by evidence about older peopleâs health and needs, particularly for populations who are most likely to be poorly. Material disadvantage plays a key role in peopleâs health. Compared to the richest populations, the poorest are more likely to experience poor health, and poor health starts earlier in their life.
The Clinical Practice Research Datalink (CPRD) may offer an opportunity to explore these issues. CPRD routinely collates patient data from GP practices across the UK. Some of the information collected may describe the material circumstances of people when these circumstances impact their health. We want to know whether it is possible to use this information to measure the number of people experiencing material disadvantage.
CPRD also includes information about area deprivation. However, we want to know whether it is possible to describe and measure the material circumstances of people, rather than the material conditions of the areas in which they live.
The aim of the work is to explore whether there is information within CPRD to count the number of people experiencing material disadvantage in primary care. We want to use this information to explore the health of the most disadvantaged older people.
Technical SummaryPromoting healthy ageing is a policy priority. This goal must be underpinned by evidence, particularly for populations most at risk of poor health. Material disadvantage plays a key role in peopleâs health. Compared to the most advantaged populations, those most disadvantaged are more likely to experience age-related poor health from earlier in the life course, for example. Targeting support at the poorest populations could help to delay the earlier onset of poor health, and close the socioeconomic gap in healthy life expectancy. The aims of our exploratory study are to explore the feasibility of using Clinical Practice Research Datalink (CPRD) data to quantify the number of people experiencing material disadvantage; and to make recommendations about the use of CPRD data to explore links between material disadvantage and health.
Within CPRD, there may be an opportunity to quantify the number of people experiencing material disadvantage through aggregating SNOMED codes relating to benefits, housing and employment, for example, and validating âmaterial disadvantageâ against Indices of Multiple Deprivation (IMD) codes at the household level. Our study population will be adults (age 18 and above) in CPRD Aurum who are eligible for linkage to patient-level area deprivation data. Our outcome of interest is material disadvantage, which we will code as (a) a binary variable from having any SNOMED code from patient observations listed and (b) grouping SNOMED codes into 9 different domains of material disadvantage (Appendix A). Our covariates will be a history of along-term condition (Appendix B), age group and sex. We will use descriptive tables and logistic regression, adjusted for age group and sex, to explore associations between material disadvantage and these long-term conditions.
Determining the utility of CPRD data to identify people experiencing material disadvantage could support future analyses on the health and care needs.
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Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH) - a DARWIN EU study — Antonella Delmestri ...
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Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH) - a DARWIN EU study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-03
Organisations:
Antonella Delmestri - Chief Investigator - University of Oxford
Antonella Delmestri - Corresponding Applicant - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of OxfordOutcomes:
This study will examine the following four primary outcomes of interest:
(1) Initiation of treatment for PAH
Initiation of treatments will be assessed within a window of 30, 90, and/or 365 days following diagnosis. PAH treatments will include Ambrisentan, Bosentan, Macitentan, Sildenafil, Sitaxentan, and Tadalafil.(2) All cause-hospitalisation
All-cause hospitalization will be determined by examining CPRD GOLD READ codes mapped to SNOMED indicating inpatient visits or hospital admissions following the diagnosis of PAH (i.e. index date). This will be assessed in a window of 365 days following diagnosis of PAH.(3) Cardiovascular hospitalization
Cardiovascular hospitalisation will be identified through CPRD GOLD READ codes mapped to SNOMED indicating hospital admissions for cardiovascular events following the diagnosis of PAH (i.e. index date). This will be assessed in a window of 365 days following diagnosis of PAH.(4) Mortality
Overall mortality in patients with PAH will also be identified based on the registered date of death in CPRD GOLD patient data.Description: Lay Summary
This study is about a rare type of disease, called Pulmonary Arterial Hypertension, characterized by high blood pressure in the lungs blood vessels, which carry blood from the heart to the lungs. There are 4 types of this disease, based on its origin (i.e. unknown, genetic, induced by drugs, caused by another condition). The therapeutic management in clinical practice varies based on type and severity, and usually involves a mono or combination targeted therapy. Despite therapeutic advancements, this disease is still considered fatal, with a very low survival time, depending on the type and may vary between individuals.
The European Medicines Agency has commissioned the Data Analysis and Real-World Interrogation Network (DARWIN) European Union (EU) centre to understand how this disease is treated in clinical practice in Europe. We will contribute to this network via federated analyses to give answers for affected patients.
We will use data between 01/01/2012 and 31/12/2022 from Clinical Practice Research Datalink (CPRD) GOLD database to understand better affected patients in the UK, the prescription patterns used in clinical practice, and their effectiveness, together with risks and benefits.
This study has the potential to offer policy makers an informed baseline for the development of better guidelines focussed on improving therapeutic management for this disease.
Technical SummaryPulmonary Arterial Hypertension (PAH) patients have a median survival of about 7 years from the time of diagnosis. The therapeutic management differs based on type and severity and usually involves a mono or combination therapy from: ERAs (Endothelin receptor antagonists), and PDE5-is (Phosphodiesterase-5 inhibitors). The European Medicines Agency has commissioned the DARWIN EU centre to understand how PAH therapies are used in clinical practice to contextualise assessments of potential future development programs in this indication.
Objectives:
(1) To estimate proportions of individuals with PAH who initiate treatment with ERAs or PDE-5is, either as monotherapy or in combination, from 01/01/2012 to 31/12/2022.
(2) To estimate the duration of prescription for ERAs and PDE-5is in patients with PAH between 01/01/2012 and 31/12/2022.
(3) To describe the prescription patterns of ERAs PDE-5is in patients newly diagnosed with PAH between 01/01/2012 and 31/12/2022.
(4) To estimate the proportion of patients with the following events of interest: cardiovascular hospitalization, all-cause hospitalization and death among individuals newly diagnosed with PAH between 01/01/2012 and 31/12/2022.Study design: a retrospective cohort study in individuals newly diagnosed with PAH using CPRD GOLD data mapped to OMOP CDM.
- Patient level characterization - Objectives 1, 3 and 4
- Patient level drug utilization - Objective 2Drug exposures: Ambrisentan, Bosentan, Macitentan, Sildenafil, Sitaxentan, Tadalafil will be defined through DM+D and/or Gemscript drug codes mapped to RxNorm codes.
Condition exposure: PAH, defined through READ codes mapped to SNOMED codes.Outcomes: presence of events of cardiovascular hospitalisation, all-cause hospitalisation, and death.
Methods: Proportions, patient level drug utilisation to assess duration of use of the first exposure episode of the respective drugs of interest.
The proposed research has the potential to inform new health policies for the benefit of PAH patients, to support better clinical practice and the health care system.
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Vascular disease and cancer: cohort studies of adult cancer populations and outcomes — Umesh Kadam ...
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Vascular disease and cancer: cohort studies of adult cancer populations and outcomes
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-14
Organisations:
Umesh Kadam - Chief Investigator - University of Exeter
Umesh Kadam - Corresponding Applicant - University of Exeter
Ke Li - Collaborator - University of Exeter
Krasimira Tsaneva-Atanasova - Collaborator - University of Exeter
Sarah Bailey - Collaborator - University of ExeterOutcomes:
Hospital admissions; mortality; cardio-metabolic diseases; cardiovascular diseases; thromboembolism; cerebrovascular diseases; cancer-related outcomes; frailty
Description: Lay Summary
It is estimated that there are 2.5 million people living with cancer in United Kingdom at any one time. In adults with a new diagnosis of cancer, they will often also have a range of vascular diseases. Since cancer treatment itself creates new vascular risks, understanding the relationship between the two conditions (âinteractionâ) becomes important, both in terms of how risk changes and how the outcomes of the two conditions are affected.
Technical Summary
âVascular diseaseâ encompasses the range from problems of the heart, sugar, brain, peripheral areas such as legs to problems of the eyes and kidneys. In the adult population aged 40 years and over with a new diagnosis of breast, prostate, gastro-intestinal or lung cancer will be matched to populations without cancer, we will investigate: (i) the risk factors, vascular disease, and drug treatment status prior to diagnosis of new cancer; (ii) risk measurements before or at the point of new cancer diagnosis, (iii) how cancer and vascular diseases combine to impact on vascular, cancer-related and frailty outcomes, and highlight the factors that can be changed to prevent long term complications. Understanding how the treatment of cancer changes vascular risk and outcomes of both is key to devising new approaches to current public health prevention programmes that are in place nationally and internationally.Background: Newly diagnosed adult patients with cancer often have other common chronic conditions, such as a range of vascular disease. It is known that cancer treatment increases vascular risks. However, there is little evidence on the population level vascular status at the point of adult cancer diagnosis and how this combination interacts to affect longer-term outcomes in populations.
Design: Descriptive and Cohort studies.
Methods: In linkage datasets, comprising CPRD Gold, Aurum, National Cancer Registration, Analysis Service, Hospital Episode Statistics (HES) and ONS death data, we will construct four cohort groups of breast, prostate, gastrointestinal tract and lung cancer and four matched non-cancer cohorts. There will be assessment of: (i) baseline vascular risk factors at cancer diagnosis and change in risk factors following cancer diagnosis using longitudinal mixed models, (ii) risk modelling scores at baseline (iii) risk of cancer, vascular and frailty outcomes at 1, 3 and 5 years using flexible parametric survival models for competing risks, and (iv) estimation of population attributable fractions for potentially modifiable risk factors.
Outcomes: This investigation will determine vascular status and outcomes in adult populations with cancers and such evidence will be crucial in devising public health policies which incorporate routine risk monitoring and assessments for an increasing adult population of cancer survivors.
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Feasibility and assessment of the association between opioid use and the development of diverticulitis — Samy Suissa ...
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Feasibility and assessment of the association between opioid use and the development of diverticulitis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-15
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Antonios Douros - Corresponding Applicant - McGill University
Carolina Moriello - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
David Juurlink - Collaborator - Institute for Clinical Evaluative Sciences ( ICES )
Laura Targownik - Collaborator - University of Toronto
Matthew Dahl - Collaborator - University of Manitoba
Michael Paterson - Collaborator - Institute for Clinical Evaluative Sciences ( ICES )
Michael Webster-Clark - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
First, we will assess the number of patients with opioid use (new use or prevalent use) among those with an elective surgical procedure. Second, we will assess the following three definitions of diverticulitis of increasing severity: 1) inpatient primary discharge diagnosis with CT scan; 2) diagnosis with surgical intervention during hospitalization; and 3) diagnosis with mortality during hospitalization.
Description: Lay Summary
Opioids are drugs that are very commonly used for the treatment of pain. One well-known side effect of opioids is constipation. Constipation may increase the risk of diverticulitis. Diverticulitis is defined as the infection of small sacs within the large bowel (called diverticula), which are common in older adults. The symptoms of this infection are often mild. However, severe and even fatal courses of this infection are also possible. Therefore, it is important to know if the use of opioids is related to an increase in the risk of diverticulitis. Prior observational studies had important limitations. Thus, to address this knowledge gap, we intend to do a study using the Clinical Practice Research Datalink (CPRD). The study will also be done separately using other healthcare databases in Canada and in the United States. As a first step, we will assess whether the study that we intend to do is feasible. To this end, we will count the number of patients in the CPRD who have conditions where treatment with opioids is recommended . We will also describe the patterns of the use of opioids and the frequency of hospitalizations with diverticulitis in these patients. After the assessment of feasibility, we will compare the rates of hospitalizations with diverticulitis between users of opioids and non-users of opioids. The results of this study will improve our understanding on the patterns of use of opioids in the United Kingdom. They will also improve our knowledge on the safety of opioids.
Technical SummaryOpioid-induced constipation may increase the risk of diverticulitis. While many cases of diverticulitis are mild and treated with antibiotics at home, diverticulitis can also be life-threatening. A major limitation of prior observational studies assessing the association between opioid use and risk of diverticulitis was protopathic bias. To avoid this bias, we will ensure that opioid users and non-users have both recently experienced an indication for opioid treatment that could not be confused for the symptoms of diverticulitis (e.g., elective surgical procedure). However, conditioning on specific indications will reduce sample size.
To assess the feasibility of performing a comparative study using this approach within the Clinical Practice Research Datalink, we will undertake a descriptive study assessing the number of patients with an elective surgical procedure, a specific indication for opioid use, as well as the prevalence of new opioid users, opioid non-users, and prevalent opioid users with this indication 90, 180, 365-day, and âever beforeâ lookback periods to define new use. We will also assess the frequency of hospitalizations with diverticulitis diagnoses and CT-scan procedures within 30-, 60-, 90-, 180-, 365-, 730-days, and the rates of various diverticulitis definitions. Moreover, we will assess the duration of intention-to-treat and as-treated follow-up time available for each exposure group (non-users, new users, prevalent users) within each opioid indication group.
After the assessment of feasibility, we will conduct a comparative safety study. To this end, we will compare crude and weighted (to account for confounding and selection bias) estimates of the incidence rate ratio, incidence rate difference, and risk ratios and risk differences at 30, 180, and 730-days for diverticulitis and severe diverticulitis comparing new and prevalent users of opioids to non-users after adjusting for confounding variables.
This study is part of a larger project conducted within the Canadian Network for Observational Drug Effects Studies.
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Management of musculoskeletal pain in ChiLdren and young people wIth Mental health or neurodivergent comorBidity (CLIMB) — Kayleigh Mason ...
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Management of musculoskeletal pain in ChiLdren and young people wIth Mental health or neurodivergent comorBidity (CLIMB)
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-03
Organisations:
Kayleigh Mason - Chief Investigator - Keele University
Kayleigh Mason - Corresponding Applicant - Keele University
David Jenkinson - Collaborator - Keele University
Faraz Mughal - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Kate Dunn - Collaborator - Keele UniversityOutcomes:
The management of children and young people with incident musculoskeletal pain will be determined using new consultations, prescriptions or referrals recorded in primary care in the 24 months after the index date:
i. Consultations to primary care in 24 months after index date: number of consultations and whether there were consultations for musculoskeletal pain, mental health/neurodevelopmental comorbidity, or other conditions.
ii. Prescriptions in primary care in 24 months after index date: number of different therapies prescribed.
Analgesia prescriptions will also be categorised according to strength into categories based on those for adults and refined for the CAM-Pain programme (basic, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, moderate opioids, strong opioids and very strong opioids (Bedson et al. 2013)).iii. Referrals from primary care in 24 months after index date: number of referrals to secondary care. Referrals will be categorised according to destination: paediatric, rheumatology, pain clinic, orthopaedics, physiotherapy, and mental health.
Time to referral will be calculated between the index date and earliest date of referral to secondary care in 24 months after index date.Description: Lay Summary
The aim of this project is to investigate whether children and young people (aged 8-18 years) with joint or muscle pain are managed differently by their doctor (GP) if they also have a mental health (e.g. depression) or neurodevelopmental condition (e.g. autism) compared to young people with joint or muscle pain only. This is an important topic as joint or muscle pain can be disabling for children or young people and being given different medicines for joint or muscle pain because of having another condition could have a big impact on day-to-day life.
Using a national database of anonymous patient records from general practice, we will investigate:
⢠how many young people with new joint or muscle pain have visited their GP for a mental health or neurodevelopmental condition in the 2 years before their joint or muscle pain consultation.
⢠how often young people with new joint or muscle pain (i) visit their GP, (ii) are prescribed painkillers, or (iii) see a specialist, in the 2 years after their joint or muscle pain consultation.The rates between children and young people with joint or muscle pain and a mental health or neurodevelopmental condition will be compared to those with joint or muscle pain only. The results of this study will feed into a larger research study, which aims to help doctors work out which children and young people are more likely to get better.
Technical SummaryThe aim of this project is to investigate whether children/adolescents with incident musculoskeletal pain are managed differently in primary care if they also have mental health/neurodevelopmental comorbidity compared to young people with musculoskeletal pain only. This is an important topic as musculoskeletal pain can be disabling for children/adolescents and the increased burden of mental health/neurodevelopmental comorbidity could adversely impact on quality of life depending on which conditions are prioritised.
Using the Clinical Practice Research Datalink (CPRD) Aurum database of anonymised patient records in UK primary care, the study population comprises children/adolescents aged 8-18 years with a consultation for musculoskeletal pain between 2005-2021. We will investigate:
⢠the proportion of children/adolescents with incident musculoskeletal pain who visited primary care for mental health/neurodevelopmental comorbidity in the 2 years before their musculoskeletal pain developed;
⢠how often children/adolescents with incident musculoskeletal pain (i) consult their GP, (ii) are prescribed analgesia, or (iii) are referred to secondary care, in the 2 years after their index consultation.
The rates of consultation, analgesia and referrals for children/adolescents with musculoskeletal pain and a mental health/neurodevelopmental comorbidity will be compared to those with musculoskeletal pain only using relevant regression analyses and will be adjusted for age, gender, ethnicity, geographical region and linked index of multiple deprivation data.Children/adolescents with lived experience of musculoskeletal pain have informed this studyâs conception and will be invited to advise on the project at all stages to make sure the study results will be helpful to healthcare practitioners.
Key findings from this study will be communicated to healthcare practitioners, commissioners and policymakers to better inform the optimal management of musculoskeletal pain in children/adolescents with mental health/neurodevelopmental comorbidity in primary care. Findings will also be linked into a wider programme grant (NIHR203281; linked CPRD protocols 22_002318 and 23_002782).
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Characterisation of Medication Utilisation and Clusters Prior to, During and After Pregnancy: A Population-Based Descriptive Study — Kenneth Man ...
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Characterisation of Medication Utilisation and Clusters Prior to, During and After Pregnancy: A Population-Based Descriptive Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; CPRD Aurum Ethnicity Record; CPRD Aurum Pregnancy Register; CPRD GOLD Ethnicity Record; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-22
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Adrienne Chan - Corresponding Applicant - UCL School Of Pharmacy
Ian Wong - Collaborator - University College London ( UCL )
Siu Chung Andrew Yuen - Collaborator - UCL School Of PharmacyOutcomes:
1) Patterns of medication clusters, which will be compared between time periods before, during and after pregnancy. Medications included will be drugs used for infection (i.e. antibiotics, antiviral, vaccines), psychiatric conditions (i.e. antipsychotics, antidepressants, antixiolytics, hypnotics, sedatives, stimulants) and somatic conditions (i.e. drugs that impact the gastro-intestinal, cardiovascular, respiratory, central nervous, endocrine systems, as well as drugs for obstetrics, gynaecology, urinary-tract disorders, malignant disease, immunosuppressants, nutrition and blood disorders, and musculoskeletal and joint disorders);
2) Medication clusters by pre-existing chronic conditions, i.e. comprised of just pregnant women with pre-existing psychiatric and behavioural disorders, endocrine, nutritional and metabolic diseases, diseases of the central nervous system, cardiovascular diseases, diseases of the respiratory system, diseases of the digestive system, diseases of the musculoskeletal system and diseases of the genitourinary system;
3) Medication clusters by ethnicity groups. In all cases, medications are identified by British National Formulary (BNF) chapters, conditions are identified by Read, SNOMED and ICD-10 codes, and ethnicity groups will be based on the CPRD ethnicity record.Description: Lay Summary
Pregnancy involves numerous physical changes and adaptations in a woman's body, impacting various bodily functions and possibly complicating existing health conditions. Meanwhile, medicines used during pregnancy present unique challenges in clinical practice, as pregnant women are rarely included in randomised clinical trials. This leads to a significant knowledge gap and evidence inequality in understanding the effect of medication during pregnancy and could potentially disrupt the ongoing medication treatment.
This study will characterise medications that are commonly used in pregnant women and can be grouped together based on similar usage before, during and post-pregnancy in the United Kingdom. Networks (a system of interconnected medications) will illustrate how medication clusters change throughout pre-, during and post-pregnancy periods. These medication clusters could illuminate potential inappropriate prescribing practices for pregnant women and prioritise further medication safety research. Understanding medication use patterns in pregnancy will inform the development of safe treatment plans and could help guide the creation of clinical guidelines for treating pregnant women with different medical conditions.
Medications used for treating infection, mental health and other physical health conditions are commonly used during pregnancy. There is not much evidence supporting the safety of using these medications during pregnancy, especially on the potential risks for the foetus. Our proposed study will perform a secondary analysis that focuses on these three major types of medications in the network and clusters.
Technical SummaryPregnancy can complicate treatment plans for comorbidities, potentially leading to adverse outcomes. We aim to determine the drug utilisation and how medication clusters for comorbidities change before, during, and following pregnancy, including psychotropics. This study will help understand patterns in medications throughout pregnancy, which is essential to implementing safe treatment plans and could help focus the development of clinical guidelines for treating pregnant women with various health conditions. Our cohort will include pregnant women between 01/01/1998 and 31/12/2022 aged 15 to 45 years old. The outcomes will be drugs used for infection, psychiatric and somatic comorbidities during the same period.
Treatment episodes for each medication will be calculated using the Proportion of Days Covered approach with 20% added to the prescription duration to account for imperfect adherence. There will be a 14-day medication-free grace-period before a new treatment episode is assigned. Co-medication will be defined as overlapping treatment periods of two drugs.
Networks will be generated in the periods before, during and post-pregnancy. Nodes will represent medications and size proportional to the prevalence of that drug in the cohort. Edges will be weighted by the proportion of the cohort who were co-medicated with those drugs. Networks will be stratified by calendar year, baseline comorbidities and trimester of pregnancy.
Modularity analysis will be applied to characterise clusters from the networks using clustering methods. Networks will be generated for associations between drugs prescribed to investigate prescribing overall. Edges will be weighted by the magnitude, adjusted using the Benjamini-Hochberg method, of the partial Pearsonâs correlations between the two medications.
An interactive tool will be created to enable exploration of the networks created, providing a tool to explore patterns in medicine use for pregnant women. This will potentially assist in identifying trends, understanding medication interactions and promoting safe prescribing practices during and after pregnancy.
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A treat to target approach for obesity management: exploring potential treatment targets — Camilla Morgen ...
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A treat to target approach for obesity management: exploring potential treatment targets
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-08-09
Organisations:
Camilla Morgen - Chief Investigator - Novo Nordisk A/S
Camilla Morgen - Corresponding Applicant - Novo Nordisk A/S
Abd Tahrani - Collaborator - Novo Nordisk A/S
Luca Busetto - Collaborator - University of Padova
Rafael Bravo - Collaborator - Novo Nordisk A/S
Ricardo Arturo Reynoso Mendoza - Collaborator - Novo Nordisk A/S
Silvia Capucci - Collaborator - Novo Nordisk A/S
Volker Schnecke - Collaborator - Novo Nordisk A/SOutcomes:
Primary Endpoint:
10-year absolute risk of:
⢠Type 2 diabetes
⢠Atherosclerosis
⢠Hypertension
⢠Hip/knee osteoarthritisExploratory endpoint:
⢠Conversion to normotensive status/no use of antihypertensive medication for individuals with hypertension.
⢠Change of HbA1c to a level in the non-diabetic range for individuals with type 2 diabetes.Description: Lay Summary
This study aims to test different targets for managing obesity to see which one is most effective in avoiding future health problems related to obesity. These health problems are type 2 diabetes (too high blood sugar), high blood pressure, hardening of the arteries, and problems with the hips and knees. The weight related targets we will examine are focused on the weight status after your weight loss, how much weight you lose (percentage) and your waist size after the weight loss.
To achieve this, the study will examine data from adults aged between 18 and 60 years who have a record of their weight, height, and waist size. These individuals will be followed for three years to track their weight changes, and statistical models will be used to determine how the different weight related targets affect their risk of developing health problems.
The study proposes to combine measurements of waist and height with weight to better predict future health problems compared to weight alone. The results of this study can help doctors and patients make better decisions when managing obesity and improving treatment outcomes.
If the study finds an effective target for managing obesity, it will be easier for doctors to design effective treatment plans, and patients will have a better understanding of how to manage their weight to avoid obesity-related health problems.
This study can also help to raise awareness of the importance of maintaining a healthy weight and adopting healthy lifestyles to prevent obesity.
Technical SummaryTreatment targets help physicians and patients make decisions regarding treatment intensification and help patients manage their conditions. However, there is currently no established treatment target for obesity management.
We will test potential treatment targets for obesity management to understand which one will perform best in predicting a low risk of four selected obesity related complications (ORCâs) (Type 2 diabetes, hypertension, atherosclerosis, and hip/knee osteoarthritis).
We will examine:
⢠The association between Body Mass Index (BMI), waist-height ratio (WtHR), waist circumference (WC) and risk of developing selected ORCs
⢠The associations between change in BMI, WtHR, WC and risk of developing ORCs
⢠How treatment targets (BMI <30 kg/m2, % weight loss, (WtHR) < 0.5, and WC< 80/94 cm for women/men), perform in indicating that a low risk based on the 10-year ORC incidence in individuals without obesity has been reached.We include adults (18-60 years) with a BMI record, a height and WC measurement between January 2010 and December 2014 (year 1), and a record/measurement during year 3. Given the change in BMI, WtHR and WC from year 1 to 3, we will use Cox proportional hazard models to estimate the associations between BMI, WtHR, WC and changes in these measures, reaching pre-selected targets and risk of developing four selected ORCs.
Event is defined as the earliest diagnosis code in CPRD Aurum or International Classification of Diseases-10 code in HES Admitted Patient Care. Underlying time scale is calendar time.
Analyses will be adjusted for: Index BMI, age, sex, ethnicity, smoking, socioeconomic status, baseline comorbidities, baseline biomarker values, baseline drugs prescribed and Charlson Comorbidity Index (modified).
We hypothesize that WtHR/WC and BMI will be more precise than BMI alone in predicting a future risk of ORCs.
The results can empower patients to manage their condition and guide clinicians in treatment decisions.
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ID-162-3: Extension: Factors influencing uptake of seasonal influenza vaccination amongst pregnant women — Imperial College London...
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ID-162-3: Extension: Factors influencing uptake of seasonal influenza vaccination amongst pregnant women
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Vaccination.
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ID-259-2: Extension: JSNA Program — Westminster City Council...
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ID-259-2: Extension: JSNA Program
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: JSNA.
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ID-183-3: Extension: Estimating inequalities in unmet clinical need in patients with obesity — Lane Clark & Peacock LLP...
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ID-183-3: Extension: Estimating inequalities in unmet clinical need in patients with obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Obesity. Commercial
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ID-263-1: Extension: Harrow Integrated Intermediate Care Programme — CLCH on behalf of the Harrow Borough...
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ID-263-1: Extension: Harrow Integrated Intermediate Care Programme
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-23
Opt Outs: no information provided./p>
Organisations: CLCH on behalf of the Harrow Borough-Based Partnership
Description: Intermediate Care.
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ID-252-2: Extension: Grenfell Bereaved and Survivors Population Health Monitoring — missing...
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ID-252-2: Extension: Grenfell Bereaved and Survivors Population Health Monitoring
Legal basis:missing
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-23
Opt Outs: no information provided./p>
Organisations: missing
Description: Grenfell.
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ID-305-1: Extension: Case mix severity — Imperial College London...
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ID-305-1: Extension: Case mix severity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Emergency Care.
Source
2023 - 07
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Investigating socioeconomic, household, and environmental risk factors for Covid-19 in Scotland — unknown...
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Investigating socioeconomic, household, and environmental risk factors for Covid-19 in Scotland
Where: unstated
When: 2023-7-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
There is growing evidence that a range of factors may put some groups at greater risk in the Covid-19 pandemic. These may include types of occupation, household and housing conditions, or environmental factors such as exposure to air pollution. Such risk factors may help explain why the Covid-19 pandemic has disproportionately affected groups with lower socioeconomic status.
This study aims to use linked administrative data to enhance our understanding of non-health risk factors such as occupation, household, and environmental circumstances. It will help to inform future policies to support populations at higher risk.
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Deaths at home during the Covid-19 pandemic in Scotland — unknown...
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Deaths at home during the Covid-19 pandemic in Scotland
Where: unstated
When: 2023-7-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The Covid-19 pandemic has seen a large increase in the number of people dying at home. Deaths at home have increased by 36% relative to pre-pandemic levels. Only about 2% of those deaths were Covid-19 related, with most deaths happening due to other causes.
This project builds on ADR Scotlandâs earlier work, exploring the increase in deaths at home during the Covid-19 pandemic and its implications for end-of-life care and health service usage.
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Analysing labour market transitions: 2011 Census linked to Benefits and Income â England and Wales — unknown...
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Analysing labour market transitions: 2011 Census linked to Benefits and Income â England and Wales
Where: unstated
When: 2023-7-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The overall aim of this project is to significantly enhance knowledge of labour market transitions for disadvantaged groups.
The project will study how the disadvantages suffered by certain groups can vary over their life course or change in relation to factors such as household circumstances and geographical context. These groups have been identified by health and disability status, caring responsibilities, migrant status, and ethnicity. The project team will analyse the impact of different forms of disadvantage on labour market outcomes, measured by receipt of benefits related to non-working status.
This work relates to employment and welfare policies, but also to other areas such as health and social care. It has been designed in close collaboration with the Department for Work and Pensions and the Office for National Statistics (ONS). It is part of a wider ADR UK initiative involving researchers across the devolved nations, who collaborate on research using the same data collection: the ONS 2011 Census linked to Benefits and Income â England and Wales dataset.
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Diabetes and related complications in Autism Spectrum Disorder compared to general population controls — Asaad Baksh ...
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Diabetes and related complications in Autism Spectrum Disorder compared to general population controls
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-04
Organisations:
Asaad Baksh - Chief Investigator - King's College London (KCL)
Asaad Baksh - Corresponding Applicant - King's College London (KCL)
Andre Strydom - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes:
Incidence of diabetes mellitus (type 1 and type 2); ophthalmic, neurological, renal and macrovascular complications associated with diabetes (retinopathy, neuropathy, onset of microalbuminuria and chronic kidney disease, stroke, ischaemic heart disease); quality of care measures using a combination of outcome measures from the Quality and Outcomes Framework (QOF) Indicators, the Organisation for Economic Co-operation and Development (OECD) quality of care indicators and NICE guidelines. Rates of eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge-eating disorder).
Description: Lay Summary
Autism spectrum disorder (Autism) is a condition that affects the way some people think, feel, and behave. People with Autism may be more likely to be overweight than the general population and may be more likely to develop other related conditions like diabetes. Diabetes is an illness that means your body does not use sugar normally and there are two types: insulin-dependent (type 1) and non-insulin-dependent (type 2). The NHS Long Term Plan aims to improve the health of people with Autism, but there are gaps in our understanding of the risks related to conditions like diabetes.
We will use CPRD to compare diabetes in Autism to the general population. We will look at how diabetes is different depending on peopleâs body fatness, how males and females differ, their age and look at how common the different types of diabetes are. We will investigate how having an intellectual disability diagnosis and Autism together, and being on medication for mental health conditions, might affect how common diabetes is in Autism. We will look at how well people with diabetes and autism are cared for and investigate what kind of complications they get (diabetes can cause problems like with your kidneys, feet and eyes). Finally, we will look at eating disorders which are common in Autism and whether these are linked to diabetes.
By improving understanding of diabetes in Autism we can help the NHS implement their plans to improve the health of people with Autism so they can live healthier lives.
Technical SummaryPeople with Autism spectrum disorder (ASD) are at higher risk of developing medical, neurologic, and psychiatric morbidities than the general population. Rates of obesity and diabetes have been suggested to be higher in ASD in some studies. A key aim of the NHS Long Term Plan is to improve health outcomes in ASD in the context of health disparities and unmet needs currently present. We will use a matched-cohort design to address current gaps in the literature relating to the risk of diabetes in ASD across demographic variables and complications related to diabetes.
People ever diagnosed with ASD will be identified from CPRD Aurum and GOLD databases and matched to general population controls using a 1:4 ratio on sex, age and GP practice. We will examine incidence of diabetes by body mass index, sex and across the lifespan in ASD compared to the general population, explore potential differences in rates of type 1 and type 2 diabetes, estimate the impact of an intellectual disability diagnosis and psychotropic medication on diabetes diagnosis, evaluate quality of care measures including intermediate outcomes of blood pressure and blood glucose control, investigate complications associated with diabetes and evaluate the prevalence of eating disorders and whether these are associated with diabetes since eating disorders are common in ASD and might dispose some people to be at higher risk of diabetes. Our main outcomes will include incidence of diabetes (type 1 and type 2); ophthalmic, neurological, renal and macrovascular complications associated with diabetes, quality of care measures and rates of eating disorders. Linked data will be employed to estimate deprivation related inequalities in ASD and diabetes.
These analyses will provide new insights into diabetes in ASD and help to understand the unique health needs of people with ASD to inform NHS policies to address health inequalities.
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Understanding the associations between major depression and type 2 diabetes: Longitudinal trends in disease progression, care and reciprocal impact using retrospective cohort designs within the Clinical Practice Research Datalink — Jessica Tyrrell ...
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Understanding the associations between major depression and type 2 diabetes: Longitudinal trends in disease progression, care and reciprocal impact using retrospective cohort designs within the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; CPRD Aurum Ethnicity Record; Patient Level Townsend Index; Practice Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-21
Organisations:
Jessica Tyrrell - Chief Investigator - University of Exeter
Jessica Tyrrell - Corresponding Applicant - University of Exeter
Alex Dregan - Collaborator - King's College London (KCL)
Alexandra Gillett - Collaborator - King's College London (KCL)
Jack Bowden - Collaborator - University of ExeterOutcomes:
Cohort 1: Individuals diagnosed with type 2 diabetes.
Type 2 diabetes and related outcomes:
1. Glycated haemoglobin (HbA1c);
2. Age at type 2 diabetes diagnosis;
3. Type 2 diabetes medication and time on medication;
4. Adiposity measures including Body mass index (BMI) and changes in BMI over time;
5. Microvascular complications of diabetes (primary or secondary care);
6. Cardiovascular complications of diabetes (primary or secondary care);
7. Renal complications of diabetes (primary or secondary care);
8. Frailty measures coded using the electronic frailty index (eFI) from primary care data[1];
9. Alzheimerâs disease (progression to)- possible complication of MDD (primary or secondary care);
10. All cause mortality (CPRD death data).Cohort 2: Individuals diagnosed with major depressive disorder.
Major depressive disorder (MDD) and related outcomes:
1. Major depressive disorder;
2. Number of MDD episodes;
3. Age at first episode of MDD;
4. Number of antidepressants prescribed;
5. Early antidepressant switching;
6. Antidepressant resistant depression;
7. Psychiatric referral;
8. MDDâ recurrent episodes, psychiatric co-morbidity, psychiatric referral (primary or secondary care), symptom level information;
9. Frailty measures coded using the electronic frailty index (eFI) from primary care data[1];
10. Alzheimerâs disease (progression to)- possibly related to MDD (primary or secondary care);
11. All cause mortality (CPRD death data).Description: Lay Summary
Major depressive disorder (MDD) and type 2 diabetes are growing health problems, with high costs to both individuals and society. Most research focuses on either MDD or on type 2 diabetes. However, more people have both MDD and type 2 diabetes than we would expect and therefore more research is needed to understand the complex relationship between these two conditions.
Our research aims to use data from the CPRD, with over 200,000 individuals with both type 2 diabetes and MDD to test how: a) having both type 2 diabetes and MDD impacts an individual's health, b) MDD alters glucose levels for type 2 diabetics over time and c) the order and age of diagnoses alter outcomes.
Firstly, we will test how MDD alters blood glucose levels over time. All patients with type 2 diabetes are seen regularly (~ every 6 months) to have their glucose monitored. We will test if, and how, having a diagnosis of MDD as well as type 2 diabetes alters the changes in glucose levels over time and determine whether the relative timing of diagnosis (i.e. MDD before type 2 diabetes or vice versa) is important. Secondly, we will focus on individuals with MDD and test if having type 2 diabetes alters the progression of MDD. For example, do individuals with both conditions have more MDD episodes or are they more likely to develop more severe MDD?Our findings will be of crucial importance to individuals with both depression and type 2 diabetes.
Technical SummaryAims. The global prevalence of both type 2 diabetes (T2D) and major depressive disorder (MDD) is increasing. Previous research has demonstrated that diagnosis with both conditions leads poorer diabetic control and an increased risk of treatment resistant depression. This study aims to understand the temporal relationship between T2D and MDD using longitudinal health records in two cohorts: one comprising individuals diagnosed with T2D (T2D cohort) and one containing individuals diagnosed with MDD (MDD cohort). Within the T2D cohort, we will explore the association between MDD and glycaemic control (HbA1c), as well as diabetes care, across T2D disease duration. Additionally, we will investigate the effect of poor glycaemic control and MDD on the accumulation of multiple long-term conditions (i.e., cardiovascular traits), frailty, and mortality. In the MDD cohort, we will evaluate the impact of a T2D diagnosis on MDD related outcomes including the severity of MDD, antidepressant prescribing patterns and adverse outcomes associated with depression (i.e., suicide). Within both cohorts, we will examine the potential role of mediators and moderators, such as obesity and inflammation. We will conduct subgroup analyses by sex, ethnicity, and socioeconomic status whenever feasible.
Primary exposures.
T2D cohort: MDD diagnosis.
MDD cohort: T2D diagnosis.Primary outcomes.
T2D cohort: HbA1c.
MDD cohort: number of recorded episodes, age at first episode, treatment-related outcomes (i.e. psychiatric referral, anti-depressant switching).Study Design. Retrospective, longitudinal cohort study.
Methods. Multivariable longitudinal analyses will be implemented using several statistical techniques, including latent class growth mixture models, Cox proportional hazards regression and conditional multinomial logistic regression.
Linked datasets. ONS Death registration data, HES data (inpatient, outpatient, A&E), Townsend Deprivation Index (patient and practice level), CPRD Ethnicity records.
Findings. This project will provide novel information about the complex relationship between MDD and T2D, thereby informing decisions on medical management and public health strategies for both conditions.
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The efficacy and safety of concomitant treatment with valsartan and indapamide in patients with essential arterial hypertension: Outcomes in real world practice — Christopher Morgan ...
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The efficacy and safety of concomitant treatment with valsartan and indapamide in patients with essential arterial hypertension: Outcomes in real world practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-21
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Irena Orel - Collaborator - Krka - Slovenia
Sara Redenšek Trampuž - Collaborator - Krka - Slovenia
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Systolic blood pressure change, diastolic blood pressure change, adverse events (agranulocytosis, abnormal hepatic function, acute angle-closure glaucoma, agranulocytosis, angioedema, aplastic anaemia, arrhythmia, arthralgia, back pain, blood glucose increased , blood uric acid increased , blurred vision, choroidal effusion, constipation, cough, diarrhoea, dizziness/vertigo, dry mouth, electrocardiogram qt prolonged , elevated liver enzyme levels, erectile dysfunction, fatigue, haemolytic anaemia, headache, hepatitis, hypercalcaemia, hyperkalaemia, hypersensitivity reactions, hypochloraemia, hypokalaemia, hypomagnesaemia, hyponatraemia, hyponatraemia, hypotension, increased liver enzymes, leukopenia, maculopapular rashes, muscle spasms, muscular weakness, myalgia, myopia, nausea, neutropenia, pancreatitis, paraesthesia, photosensitivity reaction, hepatic encephalopathy in case of hepatic insufficiency, worsening of pre-existing acute disseminated lupus erythematosus, pruritis, purpura, rash, renal failure, renal impairment, including renal failure in susceptible patients, rhabdomyolysis, Stevens-Johnson syndrome, syncope, thrombocytopenia, torsade de pointes), toxic epidermal necrolysis, urticaria, vertigo, visual impairment, vomiting).
Description: Lay Summary
Hypertension (high blood pressure) is a condition that affects approximately 1 in 3 people in the UK. People may not know they have hypertension until their blood pressure is measured but the condition is associated with a range of complications including heart attacks and strokes. Whilst blood pressure can be lowered by dietary changes such as reducing salt intake, stopping smoking and increasing exercise, some patients may require blood pressure lowering medications. Different types of medications exist and some patients may take multiple tablets if their blood pressure is not controlled by one type of tablet alone. There is evidence that minimizing the number of tables a patient takes may improve outcomes. Therefore, different types of blood pressure therapies can be combined into one tablet. We want to examine the efficacy and safety of taking two blood pressure drugs, valsartan and indapamide, together. We will select patients diagnosed with hypertension in the Clinical Practice Research Datalink who are initially prescribed one of these drugs and then have the other added to their therapy. We will then compare their blood pressure before they have the second drug added to measurements recorded at between 30â150 days and 90â270 days after the second drug was started. We will also compare any side effects that might have occurred to other patients with hypertension treated with one of the drugs who have a different drug added. This will provide useful data, which may improve patient outcomes by increasing the effectiveness of blood pressure lowering therapies.
Technical SummaryHypertension, affecting one in three of the UK population, is associated with increased vascular complications. Hypertensive patients whose blood pressure remains uncontrolled with one anti-hypertensive therapy may benefit from an additional anti-hypertensive added to their regimen. This study aims to evaluate the efficacy and safety of concomitant valsartan and indapamide therapy within the Clinical Practice Research Datalink Aurum and GOLD databases using a retrospective cohort design. Patients with essential arterial hypertension prescribed valsartan or indapamide at a stable dose augmented with the other monocomponent will be selected. Patients with secondary hypertension or those whose other antihypertensive agents change within one month before the index date will be excluded. The combination of valsartan in two different strengths and indapamide will be presented separately and compared. Index date will be the date that valsartan and indapamide are prescribed in combination. Systolic (SBP) and diastolic (DBP) blood pressure measurements at baseline and checkpoints 1 (30â150 days post-index) and 2 (90â270 days post-index) will be compared using the dependent t test or paired sample Wilcoxon signed ranks test depending on the distribution. Between groups comparisons for different strengths of valsartan will use the independent t-tests (or Mann-Whitney U test). The proportion of patients reaching targets (DBP <90 mmHg, SBP <140 mmHg, DBP reduction of â¥10 mmHg or SBP reduction of â¥20 mmHg) will be reported and compared to the baseline using the Chi2 test. The incidence of safety events will be reported in the year post index and incidence rate ratios compared (mid-p test) to a reference group whose antihypertensive therapy (valsartan or indapamide) is augmented with a different antihypertensive agent. This study will provide valuable data that will assist in the potential development of a fixed dosed combination therapy and inform the impact on outcomes with ultimate efficiencies for health services.
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Predicting smoking pack-years using routinely collected smoking data — Jennifer Quint ...
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Predicting smoking pack-years using routinely collected smoking data
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-28
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Alexander Adamson - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Xizhuo Chu - Collaborator - Imperial College LondonOutcomes:
Smoking pack-years
GP attendance rate (for Aim 6 only)Description: Lay Summary
Information on smoking is very important for many different study questions, but whilst current smoking status is often recorded by GPs, it can be challenging to understand the extent of an individual's smoking habits over their entire life. However, this information is crucial for certain research projects to account for the individualâs risk of disease. Our study aims to create a way to estimate a person's total smoking exposure, known as "pack-years," using regular electronic health records from GPs. We will create two different methods to do this, one using a traditional statistical technique called linear regression, and another using advanced computer techniques known as machine learning. Both of these techniques will give us a âprediction modelâ that can be used to estimate a patientâs pack-years even if this is not recorded by their GP. These models will be built using information related to smoking in the patient record, and the results of each model will be compared to each other and to other techniques to find out which one works best for predicting pack-years. We will then check whether the patients whose data was used to build the model are similar to the general population of patients who have smoked. Our goal is to accurately predict an individual's smoking history to allow researchers to better account for the impact of smoking on various health conditions that they are studying, leading to more accurate study results. This will lead to a higher quality of future research that can benefit patients.
Technical SummaryIn this study, we will develop a prediction model for estimating smoking pack-years utilising data from the CPRD Aurum dataset. The primary objective is to construct two distinct models, one employing linear regression and another using a machine learning random forests model, and subsequently compare their performance compare their performance using R-squared, mean squared error, and concordance, to ascertain the most efficacious approach for predicting pack-years. Our predictors will comprise smoking codes (included as binary present/absent or number of times recorded), and time under which the patient was classed as a particular smoking category. The aim is to accurately predict pack-years from available healthcare data, allowing a more useful account of smoking's confounding effects in future epidemiological analyses when pack-year data is missing. Using only smoking codes to generate predictors ensures that the model can be seamlessly integrated as a covariate into other investigations without the possibility of predictors (such as comorbidity) being included twice in future models. We anticipate establishing a reliable, robust, and parsimonious model for predicting smoking pack-years, thus enabling better control for the confounding effects of smoking in subsequent research that uses EHR data. Applicability will be assessed by comparing the characteristics of patients with pack-years recorded to patients in whom pack-years have not been recorded using t-tests for continuous variables and chi-squared tests for categorical variables. For this part of the analysis we will also use IMD data so that we can include socioeconomic status. We will compare the results of analyses that use derived pack-years from our prediction models to those obtained using multiple imputation. This will be undertaken using an example regression model which assesses the effect of age on GP attendance rates, adjusting for other covariates that include smoking pack-years.
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Factors associated with referral to pulmonary rehabilitation and palliative care services in people with diagnosis of idiopathic pulmonary fibrosis — Jennifer Quint ...
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Factors associated with referral to pulmonary rehabilitation and palliative care services in people with diagnosis of idiopathic pulmonary fibrosis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-18
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Abdul-Hakeem Khan - Collaborator - Imperial College London
Peter George - Collaborator - Royal Brompton HospitalOutcomes:
- Referral rates for pulmonary rehabilitation and palliative care over time.
- Factors associated with referral to pulmonary rehabilitation and palliative care servicesDescription: Lay Summary
Idiopathic pulmonary fibrosis or IPF is a chronic lung disease characterised by scarring of the lungs. People with this disease become increasingly breathless and eventually lose their ability to undertake day-to-day activities. Although the disease can take a long time to develop, once diagnosed prognosis is often poor - similar to that of several cancers - with many only surviving for 3â5 years. Although there are now some drug treatments for pulmonary fibrosis, they are usually only prescribed when people have quite advanced disease. Other treatments for breathlessness such as exercise classes (pulmonary rehabilitation) are available, and these have been shown improve quality of life of people with pulmonary fibrosis. Palliative end-of-life care services, which offer symptom control and social and psychological support, have also been shown to help people cope with this life-limiting disease. Although we donât know for sure how many patients are offered these types of services, we suspect that across the UK access is poor and referral rates are low, lower than for other lung diseases and certainly for cancer. It is also not known if certain people are more likely to be referred than others. By using information from GP databases, we will find out how many patients with pulmonary fibrosis have been referred to pulmonary rehabilitation and palliative care services and whether this has improved over time. We hope that through this research, we will develop a better understanding of scarring lung diseases so that we can improve care for patients.
Technical SummaryIt has been suggested that UK incidence of idiopathic pulmonary fibrosis (IPF) is increasing, with some studies indicating that incidence has increased by 5% per year over the past decade. Once diagnosed, prognosis is often poor; average survival times iare just 3 years, which is similar to that of some cancers. There is no cure for IPF, but new anti-fibrotic drugs have been shown to slow progression of the disease. While anti-fibrotics can slow the rate of lung function decline in people with IPF, their effect on symptom burden (e.g. breathlessness) and quality of life is modest. Moreover, not all patients are eligible for anti-fibrotic treatment.
Evidence is emerging that referral to pulmonary rehabilitation and palliative care services can help to improve quality of life and symptom burden in people with IPF. While there are few UK data on referral and use of pulmonary rehabilitation and palliative care services in this patient population, we suspect it is low, lower than for other lung diseases such as COPD and cancer. Using CPRD Aurum data linked with HES outpatient data, we will describe referral patterns in people diagnosed with IPF over the last 10 years, making comparisons with rates in people with COPD and/or lung cancer. We will use Cox regression models to determine which factors are associated with referral to pulmonary rehabilitation and palliative care support services (separately). If numbers allow, we will investigate whether completing pulmonary rehabilitation reduces the risk of a subsequent hospitalisation and whether co-diagnosis of lung cancer is associated with an earlier referral for palliative care support. This work will provide basic data on referral rates and whether these have improved over time; it will also identify which patient characteristics are associated with referral â or more importantly from the perspective of informing service needs â non-referral.
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Understanding trajectories of healthcare use and costs over the multimorbidity journey: a longitudinal study — MARINA SOLEY...
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Understanding trajectories of healthcare use and costs over the multimorbidity journey: a longitudinal study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-18
Organisations:
MARINA SOLEY-BORI - Chief Investigator - King's College London (KCL)
MARINA SOLEY-BORI - Corresponding Applicant - King's College London (KCL)
Alice McGreevy - Collaborator - King's College London (KCL)
Emma Rezel-Potts - Collaborator - King's College London (KCL)
Julia Fox-Rushby - Collaborator - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)Outcomes:
Healthcare use (primary care consultations, A&E visits, hospital inpatient stays, hospital outpatient visits); healthcare costs (computed based on healthcare use and publicly available unit cost estimates).
Description: Lay Summary
Having two or more long-term conditions (multimorbidity) is increasingly common, with two-thirds of people over 65 expected to live with multimorbidity by 2035. Preventing and managing multimorbidity is challenging for health care providers, policy makers, and patients. Individuals with multimorbidity usually have to navigate a healthcare system designed for single conditions, often resulting in an unmanageable amount of appointments and medications. This patient group often experiences worse health outcomes and higher healthcare costs than those without multimorbidity. Large differences in disease combinations and severity exist among individuals with multimorbidity. Diseases tend to accumulate over time, but most studies to date characterise multimorbidity based on a single point in time. Describing trends over time and variability across patients is important to understand who has the highest risk of poor disease progression and when the peaks of healthcare need are in the multimorbidity journey. This project aims to describe how healthcare use and costs of individuals with multimorbidity change over time as individuals accumulate further conditions and across subgroups defined by medical conditions and patient characteristics such as gender and age. This research is important to understand inequalities in healthcare use and improve care for individuals with multimorbidity.
Technical SummaryPeople with multimorbidity (defined as two or more long-term conditions -LTCs) have complex healthcare needs. Costs after diagnosis of LTCs, such as cancer or diabetes, vary within and across patients over time. Understanding outcome trajectories (rather than a single data point) is important to not only describe peaks of healthcare need in the multimorbidity progression pathway, but also explore the effect of changes (such as the diagnosis of additional LTCs) along this pathway. This research aims to: (1) Describe multimorbidity trajectories in healthcare use (including primary and secondary care) and costs over time, (2) Assess how these trajectories change as new LTCs accumulate, (3) Characterise inequalities in the trajectories and their variability over time across groups defined by sociodemographic variables, such as gender and age, and (4) Describe the relationship between primary and secondary care over the multimorbidity journey to understand if services are substitutes or complements. Primary and secondary care use of individuals with multimorbidity will be identified using CPRD data (both primary care data and the Hospital Episode Statistics). The primary outcomes are healthcare use (including primary and secondary care) and costs, and the main exposure is the accumulation of LTCs and multimorbidity. A longitudinal study design will be conducted, with the use of control groups when possible to adjust for confounding. Several statistical methods will be employed and compared to identify trajectories and their changes over time, including Interrupted Time Series (ITS), Autoregressive Integrated Moving Average (ARIMA), and group-based trajectory models. Multivariate regression analysis and control groups will be applied when possible to control for confounding. This analysis will describe points in the multimorbidity journey where access to each type of service may be most crucial to reduce costs and improve health outcomes. High healthcare users will be described to inform care prioritisation efforts and clinical guidelines.
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Long COVID and subsequent clinical outcomes: a comparison of patients with and without reporting adverse drug events (ADRs) during primary care consultations — Li Wei ...
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Long COVID and subsequent clinical outcomes: a comparison of patients with and without reporting adverse drug events (ADRs) during primary care consultations
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-27
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Ubonphan Chaichana - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )Outcomes:
1.) Long COVID
2.) Subsequent clinical outcomes after long COVID including any hospitalisation, the 3-point major adverse cardiovascular events (MACE) including nonfatal stroke, nonfatal infarction and cardiovascular death (Code lists for MACE outcome are presented in Appendix 1.)Description: Lay Summary
Following coronavirus (COVID-19) infection, many people experienced long COVID (also known as post COVID) which is a new emerging condition with no specific clinical treatment guideline and agreed definition that requires further study. Many people with adverse drug events(ADRs), the unintended response to the medication, may be facing long COVID following coronavirus infection. As ADRs have become a significant problem in the primary care setting in the UK, it significantly raises healthcare costs and frequently results in hospital admissions, leads to intensive care unit requirement and death. Recent study has shown that COVID-19 patients with penicillin allergy labelled had more risk of worsening clinical outcomes compared to COVID-19 patients without penicillin allergy. However, no evidence investigated if patients with ADRs will be more likely to develop long COVID after coronavirus infection than patients without ADR.
Technical Summary
The purpose of this study is 1) to summarise the characteristics of long COVID symptoms among ADR patients 2) to evaluate whether ADR increases the risk of developing long COVID among coronavirus infection patients 3) to investigate the increased risk of long COVID among penicillin allergy labelled patients/patients with ADRs from COVID vaccine 4) to investigate the risk of subsequent clinical outcomes after long COVID among ADR patients 5) to investigate the risk of subsequent clinical outcomes after long COVID among penicillin allergy labelled patients/patients with ADRs from COVID vaccine.
This research will provide evidence to support clinical practice and to raise awareness of developing a clinical guideline and managing long COVID in ADR patients.Approximately 3.3% of UK population experienced long COVID after SARS-CoV-2 infection(5), and more research is needed to seek the best way of managing long COVID. In the UK primary care setting, adverse drug reactions (ADRs) have become a significant problem.(7) A recent study has shown that COVID-19 patients with penicillin allergy labelled had a high risk of worsening clinical outcomes compared to those without penicillin allergy(6). Nonetheless, there is a lack of studies on the impacts of ADRs on the risk of long COVID at population level.
The purpose of this study is 1.) to evaluate whether ADR increases the risk of developing long COVID among coronavirus infection patients 2.) to investigate the risk of subsequent cardiovascular outcomes after long COVID including hospitalisation, nonfatal stroke, nonfatal infarction, and cardiovascular death.
We will conduct a cohort study using data from CPRD GOLD and Aurum linked with HES APC, HES A&E data and ONS. The study population will be individuals with a confirmed positive SARS-CoV-2 infection while the exposure group will be ADR patients (individuals who had at least one valid Read code for ADR before SARS-CoV-2 infection in the medical file). The control group will be non-ADR individuals with a confirmed positive SARS-CoV-2 infection. Logistic regression will be used to assess whether the risk of long COVID is increased among patients with ADR compared to non-ADR. We will detect the mediating role of long COVID on the associations between COVID patients with ADR and subsequent cardiovascular outcomes by using mediation analysis. We will do the pre-specified subgroup analysis in penicillin allergy labelled patients who had a record of penicillin allergy in medical file using Read Codes which we will repeat the same analysis as objectives 1 and 2. Moreover, we will adjust for the potential confounding by using the propensity-scores-based approach.
Source - and 29 more projects — click to show
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Effect of statin deprescription in older patients initiated after a first cerebrovascular event or myocardial infarction on recurrence of cardiovascular events and cardiovascular mortality, a population based cohort study in the CPRD — Anthonius de Boer ...
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Effect of statin deprescription in older patients initiated after a first cerebrovascular event or myocardial infarction on recurrence of cardiovascular events and cardiovascular mortality, a population based cohort study in the CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-25
Organisations:
Anthonius de Boer - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
marcel bouvy - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes:
- Primary outcome: time until the composite end point first recurrent non-fatal myocardial infarction (ICD-10 I21) or first recurrent non-fatal cerebrovascular ischemic event (ICD-10 I63) according to the HES APC and cardiovascular mortality after the first cardiovascular event according to the ONS database or death within 30 days after a recurrent myocardial infarction or iCVA.
- Secondary outcome: Non-cardiovascular mortality
- Tertiary outcome: time until the composite end point first recurrent non-fatal myocardial infarction or first recurrent non-fatal cerebrovascular ischemic event according to the Read & HES APC and cardiovascular mortality after the first cardiovascular event according to the ONS database or death within 30 days after a recurrent myocardial infarction or iCVA.Description: Lay Summary
Statins are medications that are commonly used to reduce the risk of brain and heart attacks. Nowadays, more and more older patients are being prescribed statins. However, many of these patients tend to stop taking the medication at some point. Previous studies have shown that discontinuing statins can increase the risk of having new cardiovascular events, such as another brain or heart attack. However, these studies didn't specifically focus on the frailest patients who might not benefit from statin treatment in the first place.
To address this gap in knowledge, our goal is to investigate whether stopping statin treatment after a brain or heart attack in older patients actually raises the risk of new cardiovascular events. Our study will use anonymous data of patients aged 65 years or older with a brain or heart attack and receiving statin treatment therafter. We will analyze whether these patients eventually discontinue statin treatment and compare the rate of new brain or heart attacks, or cardiovascular-related deaths between those who continued statin treatment and those who stopped it.
To ensure a fair comparison between the two groups, we will take into account various risk factors for heart disease, such as age, smoking, body weight and frailty status. By considering these factors, we aim to determine whether ceasing statin therapy increases the likelihood of experiencing a brain or heart attack, or even death. The results of our study could provide valuable insights for healthcare professionals when making decisions about discontinuing statin therapy in older patients.
Technical SummaryThe primary aim is to investigate the effect of discontinuing statin treatment in older patients that were initially initiated on statin treatment after a stroke or MI primarily on the recurrence of cardiovascular events and secondarily on non-cardiovascular mortality. All covariates will be investigated as potential effect modifiers. A retrospective cohort study with data from The Clinical Practice Research Datalink (CPRD) will be performed. Patients eligible for participation are those aged 65 and older following hospitalisation for a first AMI or iCVA and not having received a statin for at least one year prior to hospital admission and having received a statin prescription within 90 days after hospital discharge. Time-dependent Cox regression models will be used to calculate hazard ratios for cardiovascular events and cardiovascular deaths for statin treated time compared to statin discontinued time as the time-dependent variable. Analysis will be stratified for inclusion diagnosis, age and frailty level. Results of this study can help clinicians in their discussion with older patients about weighting the risks of statin discontinuation, especially in older frail patients.
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Comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents — Samy Suissa ...
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Comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-20
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Richard Wyss - Collaborator - Harvard Medical School
Shirley Wang - Collaborator - Harvard University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
First serious-asthma related events defined as composite of asthma-related deaths, intubations,
and hospitalizations. Follow-up and measurement of the outcome will begin 1 day after initiation
of Budesonide + Formoterol versus Budesonide alone. See attached excel file for formal CPRD
definition.Description: Lay Summary
This protocol is part of the RCT DUPLICATE initiative, a project which is replicating 30+
randomized clinical trial designs using non-randomized healthcare data and comparing the results
from the trials and non-randomized studies. The goal is to better understand when and how
questions on drug effects can be validly answered with such data and used to inform regulatory,
clinical or other decision-making.This protocol focused on a phase 3 trial comparing Budesonide + Formoterol versus Budesonide
Technical Summary
alone for asthma. The trial evaluated whether one drug was better than another at first-serious
asthma related events (a composite of adjudicated death, intubation, and hospitalization). We will
replicate the trial design based on methods reported in the main trial publication.The objective of this protocol is to emulate the design of the published randomized clinical trial
(RCT): âA 6 month safety study comparing Symbicort with inhaled corticosteroid only is asthmatic
adults and adolescents. NCT01444430. We will focus on the parallel comparison of budesonide
+ formoterol versus budesonide alone for 26-weeks.The study will include all patients who contributed to CPRD data between May 2000 to June 2018
and had an established clinical history of asthma diagnosis any time prior to initiation of exposure
or referent drug. We will implement a new-user active-comparator design, where new use will be defined as no recorded use of the exposure medication or comparator medication in the 180 days prior to exposure or comparator treatment initiation. Propensity score 1-1 calliper matching will be applied at the beginning of follow-up to balance the investigator-specified covariates across treatment groups. Follow-up will begin 1 day after initiation of
Budesonide + Formoterol versus Budesonide alone. The outcome will be measured as first serious asthma-related event (a composite of adjudicated death, intubation, and hospitalization). All the patients will be
followed-up during the treatment period of 26-weeks. The primary analysis will evaluate the survival function with 95% confidence intervals after PS adjustment.This replication is part of the RCT DUPLICATE study. The goal of this project is to utilize
real-world data to replicate phase 3 or phase 4 RCTs and compare findings. The project aims to
assess reasons for success and failure to replicate RCTs using real-world data and help lay a
groundwork for regulators to gain confidence in decision making if an RCT can be duplicated by
real-world data study.
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Effects of Gastroprotective Agents and Direct Oral Anticoagulant Cotherapy on Gastrointestinal Bleeding, Intracranial Haemorrhage and Embolic Events in Patients with Atrial Fibrillation: Target Trial Emulations using Electronic Health Records — Wallis Lau ...
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Effects of Gastroprotective Agents and Direct Oral Anticoagulant Cotherapy on Gastrointestinal Bleeding, Intracranial Haemorrhage and Embolic Events in Patients with Atrial Fibrillation: Target Trial Emulations using Electronic Health Records
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-24
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Jan Chobanov - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Olivia Bryant - Collaborator - University College London ( UCL )Outcomes:
gastrointestinal bleeding requiring hospitalisation; composite measure of ischaemic stroke or systemic embolism; intracranial haemorrhage.
Description: Lay Summary
Atrial fibrillation (AF) is a heart condition that promotes the formation of blood clumps which can block blood supply to the brain causing stroke. Direct oral anticoagulants (DOACs), also known as blood thinners, are often offered to patients with AF to prevent stroke. Despite the benefits of DOACs, they can lead to bleeding in the stomach. Studies have found that gastroprotective agents (GPAs), drugs which lower the amount of acid in the stomach , can reduce the risk of stomach bleeding among people taking anti-inflammatory drugs or other blood thinners such as aspirin. However, it is unclear whether the potential benefits of GPAs also apply to DOAC users, or which specific patients could benefit from GPAs. Additionally, it is unknown whether GPAs could affect the anticoagulative effectiveness of DOACs, thereby altering the risk of stroke and intracranial haemorrhage, also known as brain bleed.
Given these uncertainties, this study aims to investigate the potential benefits and harms of GPAs among patients with AF initiating DOACs. Using de-identified electronic databases, we will investigate whether GPAs can reduce the risk of bleeding in the stomach requiring hospitalisation among DOAC users with AF. Secondly, we will examine whether GPAs can affect the risk of stroke and intracranial haemorrhage. Thirdly, we will explore which patient groups could benefit most from GPAs. These findings would help clinicians to make better informed decisions on patient suitability for DOAC and GPA cotherapy and prevent adverse bleeding events in DOAC users.
Technical SummaryAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia which increases the risk of ischaemic stroke and other embolic events. Direct oral anticoagulants (DOACs) are effective at reducing AF-related embolism but increase the risk of gastrointestinal bleeding (GIB). Studies have suggested that proton pump inhibitors (PPI) can potentially reduce GIB. However, whether these potential benefits apply to DOAC users with AF, remains unclear. Furthermore, it is unknown whether PPIs could affect the anticoagulative effectiveness of DOACs, thereby altering the risk of stroke and intracranial haemorrhage. We will use the Clinical Practice Research Datalink, linked with Hospital Episode Statistics and Office of National Statistics, to investigate the role of gastroprotective agents (GPAs) in DOAC users with AF. Patients with AF who initiated DOACs from 1st January 2016 through 30th April 2023 will be included in the study. We will compare the risk of GIB requiring hospitalisation, ischaemic stroke/systemic embolism, and intracranial haemorrhage between DOAC users who initiate PPI, H2-receptor antagonists, and non-GPA users. These findings can help guidelines and clinicians with decision making on patient suitability for DOAC and GPA cotherapy, helping prevent GIB events among DOAC users.
The study design will follow the target trial emulation framework. We will emulate separate target trials for different DOACs: edoxaban, apixaban, rivaroxaban and dabigatran. We will implement the clone-censor-weight method to allocate treatment groups. Per-protocol analyses will be conducted using marginal structural cox proportional hazards models (approximated with pooled logistic regression). Weights will control for time-varying confounding and adherence to treatment allocation. These models will obtain adherence-adjusted hazard ratios for each outcome. Standardised risk curves will be derived by incorporating a product term between exposure status and follow-up time in the models. Subgroup analyses will be performed to observe if GPAs may benefit certain patient groups.
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Change in haematocrit after institution of sodium-glucose co-transporter 2 inhibitors in patients with type 2 diabetes and its relationship with cardiorenal outcomes — Konstantinos Toulis ...
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Change in haematocrit after institution of sodium-glucose co-transporter 2 inhibitors in patients with type 2 diabetes and its relationship with cardiorenal outcomes
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-17
Organisations:
Konstantinos Toulis - Chief Investigator - University of Birmingham
Jingya Wang - Corresponding Applicant - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Luyuan Tan - Collaborator - University of BirminghamOutcomes:
Primary outcome:
composite end-point including
1. all-cause mortality,
2. myocardial infarction
3. ischaemic heart disease
4. strokeSecondary outcomes:
1. all-cause mortality.
2. myocardial infarction
3. ischaemic heart disease
3. stroke
4. transient ischemic attack
5. peripheral arterial disease
6. heart failure,
7. atrial fibrillation
8. chronic kidney disease stage 3 to 5Chronic back pain will be used as negative control outcome in this study.
Description: Lay Summary
Sodium-glucose co-transporter 2 inhibitors are a type of medication that helps kidneys remove excess sugar from the body through urine in people who have trouble regulating the amount of sugar in their blood (type 2 diabetes mellitus ). These medications also lower the chance of heart attack, heart failure or sudden interruption of blood flow to the brain (stroke) in those people who had already had one of those in the past. No definite explanation for this action has been established as yet and this has not been confirmed in people with no such history. These medications may also slow the chance of worsening of kidney function. These actions might be explained by changes in the space red blood cells take up in the total volume of the blood (haematocrit), after treatment. We wish to explore whether those people with greater changes in changes in the space red blood cells take up have better outcomes related to the heart and blood vessels and kidney. This would mean that such changes could be used to guide treatment to those who would benefit the most.
Technical SummaryAims:
To investigate whether the change in haematocrit (absolute or percentage change) after SGLT2i institution in patients with T2DM is associated with the risk of subsequent development of cardiorenal outcomes and death from any cause.
Methods/design:
We will perform a series of open cohort studies including all patients with type 2 diabetes mellitus who have been initiated treatment with SGLT2i to investigate the association of change in haematocrit with the risk of developing cardiorenal outcomes and all-cause mortality.
Outcomes:
The primary outcome is the composite end-point, including all-cause mortality, myocardial infarction, ischaemic heart disease, and stroke. Secondary outcomes are all-cause mortality, myocardial infarction, ischaemic heart disease, stroke, transient ischemic attack, peripheral arterial disease, heart failure, atrial fibrillation, and chronic kidney diseases. Back pain will be used as a negative control outcome in this study.
Exposures:
The change in haematocrit
Participants:
Individuals with a diagnosis of type 2 diabetes aged 40 years and over will be eligible for this study. All participants must have been registered with the general practice for at least one year before the index date (start of follow-up).
Covariates:
Sociodemographic characteristics (e.g. Index of Multiple Deprivation), diabetes-related characteristics, comorbidities, biomarkers, and drug prescriptions will be adjusted to account for residual confounding.
Methods:
Except for the outcome of all-cause mortality, competing risk Cox proportional hazard regression models will be used to calculate crude and adjusted hazard ratios, together with their corresponding 95% CIs.Intended public health benefit
If the magnitude of change in haematocrit is associated with the subsequent cardiorenal outcomes, it could be used as a marker of the future expected response. The public health benefit from such knowledge would be important since a more tailored approach to pharmacotherapy in type 2 diabetes might be facilitated.
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Representativeness of the Clinical Practice Research Datalink (CPRD) primary care databases in relation to wider social determinants of health in the UK Censuses 2011 and 2021-2 — Eleanor Axson ...
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Representativeness of the Clinical Practice Research Datalink (CPRD) primary care databases in relation to wider social determinants of health in the UK Censuses 2011 and 2021-2
Datasets:GP data, CPRD Aurum Ethnicity Record; CPRD GOLD Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-24
Organisations:
Eleanor Axson - Chief Investigator - CPRD
Eleanor Axson - Corresponding Applicant - CPRD
Abbie Hunt - Collaborator - CPRD
Alice Hinchliffe - Collaborator - CPRD
Chisomo Mutafya - Collaborator - CPRD
Justin Chan - Collaborator - CPRD
Kathleen White - Collaborator - CPRD
Mia Harley - Collaborator - CPRD
Rachael Williams - Collaborator - CPRD
Sonia Coton - Collaborator - CPRDOutcomes:
Distribution of and/or proportion of complete data for the following characteristics in the acceptable, currently registered populations of CPRD GOLD and CPRD Aurum:
- Geography (UK, GB, England, Scotland, Wales, Northern Ireland, English regions)
- Age
- Sex
- Ethnicity
- National identity
- Immigration status
- Language
- Religion
- Sexual orientation
- Gender identity
- Housing
- Health/disability
- Unpaid careDescription: Lay Summary
Clinical Practice Research Datalink (CPRD) collects anonymised patient data from a network of general practices across the UK.
This study is designed to describe the representativeness of CPRD primary care data in relation to the general population of the UK. We will compare the distribution of characteristics in the populations of CPRD to those of the UK using data from the UK Censuses 2011 and 2021. We will compare these populations in terms of geography, age, sex, and ethnicity.
We will assess the completeness of data in CPRD related to other factors that influence health and care (e.g., national identity, language, religion, sexual orientation, gender identity, housing, health/disability, unpaid care, etc.), meaning the proportion of patients in CPRD that have data pertaining to the relevant characteristic. If there is sufficient data pertaining to a given characteristic, the representativeness of CPRD compared to the UK Censuses will be assessed.
This project will provide a better understanding of the utility of the CPRD databases in representing the UK population and will serve to improve interpretation of research results and translation of those results into practice for patients.
Technical SummaryThis study will be a retrospective cohort study of the representativeness of the Clinical Practice Research Datalink (CPRD) GOLD and Aurum databases in relation to the UK populations at the time of the 2011 (27 March 2011) and 2021 UK Censuses (21 March 2021 for England, Wales, and Northern Ireland; 20 March 2022 for Scotland).
The following characteristics will be assessed for representativeness: geographic distribution, age, sex, and ethnicity. The distribution of these characteristics in each database and in relevant UK geographies will be compared using Pearsonâs Chi-squared. The characteristic distribution of each database and population will be compared to the characteristic distributions from the Censuses.
Additionally, the availability of data pertaining to wider social determinants of health will be assessed in CPRD, including data on national identity, language, religion, sexual orientation, gender identity, housing, health/disability, unpaid care, etc. Completeness will be assessed as the count and proportion of acceptable, currently registered patients with a usable characteristic recording. Usability will be assessed as having at least one characteristic recording, other than ânot statedâ or ânot knownâ. If there is â¥60% completeness of these additional characteristics, the representativeness of that characteristic will be assessed, as described above.
Completeness and representativeness will be stratified by age, sex, and geographic regions.
This project will benefit patients and researchers by providing up-to-date information on the representativeness of the CPRD GOLD and CPRD Aurum databases in terms of the UK population to inform choice of data sources, interpretation of results, and translation of those results into practice for patients.
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Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries. — Debabrata Roy ...
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Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-11
Organisations:
Debabrata Roy - Chief Investigator - Drug Safety Research Unit
Denise Morris - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Kathryn Morton - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Saad Shakir - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research Unit
Taylor Aurelius - Collaborator - Drug Safety Research UnitOutcomes:
Primary outcomes
- Pregnancy complications including hypertensive disorders of pregnancy (preeclampsia, eclampsia, gestational hypertension); gestational diabetes; bleeding during pregnancy; postpartum haemorrhage and pregnancy-related death.
- Adverse pregnancy outcomes including foetal death (spontaneous abortion or stillbirth); termination of pregnancy for foetal anomaly; any elective pregnancy termination and ectopic pregnancy.
- Adverse neonatal outcomes including foetal growth restriction/small for gestational age (SGA); preterm birth (<37 full gestational weeks); low birth weight (<2500 g); major congenital malformations; microcephaly (based on head circumference); low 5-minute Apgar score and neonatal death (death within 28 days of birth).Secondary outcomes
Characteristics of Spikevax utilisation according to the following predefined exposure categories: number and prevalence of exposed pregnancies/births any time during pregnancy/gestation; number and prevalence of pregnancies/births with one dose/two doses/more than two doses; number and prevalence of exposed pregnancies/births in each of the trimesters; trimester of first dose and maternal and newborn characteristics according to the exposure to Spikevax.Characteristics of Spikevax bivalent Original/Omicron BA.1 utilisation according to predefined exposure categories: number and prevalence of exposed pregnancies/births any time during pregnancy/gestation; and if feasible without reporting personal data (as number of exposed pregnancies may be small), maternal and newborn characteristics according to the exposure to Spikevax bivalent Original/Omicron BA.1.
Description: Lay Summary
The novel coronavirus (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) and has led to a global pandemic. The COVID-19 vaccine Spikevax, developed by Moderna, was approved for use in the UK on 8th January 2021 to prevent COVID-19 in the general population. Initially approved for adults (ages â¥18 years), use was later approved for ages â¥6 years and pregnant/breastfeeding women. Sometimes vaccine use is associated with side effects known as adverse events. As COVID-19 vaccines have been developed urgently, they require ongoing safety monitoring to examine these side effects.
Use of Spikevax in pregnancy and its effect on the mother and newborn are not fully understood. This UK study, as part of several studies in Europe, will use information from UK primary care electronic health records to determine the safety of Spikevax in pregnancy. The aim is to determine whether receiving the Spikevax vaccine during pregnancy is related to a higher chance of pregnancy problems including high levels of blood sugar during pregnancy, high blood pressure disorders or bleeding during pregnancy and pregnancy related death; adverse pregnancy outcomes such as foetal death, termination of pregnancy for foetal problems and any chosen pregnancy termination; as well as negative outcomes for the baby within 28-days of birth including birth before 37-weeks, growth problems, low birth weight, deformity that developed in the womb and death within 28 days of birth. It will also describe the use of Spikevax and other Moderna vaccines developed for different versions of the COVID-19 infection in pregnancy.
Technical SummarySpikevax, an mRNA-1273 vaccine, was developed by Moderna, Inc., and the United States National Institute of Allergy and Infectious Diseases (NIAID). Spikevax and a newer Moderna variant vaccine (Spikevax bivalent Original/Omicron BA.1) have been authorised across the European Union and UK to prevent COVID-19 in individuals aged 6+ years, including pregnant/breastfeeding women. Spikevax bivalent Original/Omicron BA.4-5 (UK approval given November 2022) is authorised for use in those aged 12+ years, including pregnant/breastfeeding women.
As COVID-19 vaccines have been developed urgently, they require ongoing safety monitoring to examine side effects. Pregnant women were not eligible to participate in US Phase 3 trials for the Spikevax vaccine. However, preliminary findings from an observational study in the US were not indicative of obvious safety signals among pregnant persons who received mRNA COVID-19 vaccines. However use of Spikevax in pregnancy and its effect on the mother and neonate are not fully understood, and the need for longitudinal follow-up in a large number of pregnant women remains. Therefore, this post-authorisation safety study (PASS) aims to describe use of Spikevax and Moderna variant vaccines in pregnancy and determine whether exposure during pregnancy is associated with an increased risk of pregnancy complications, adverse pregnancy outcomes, major congenital malformations in the offspring (overall and organ-specific if feasible) and/or adverse neonatal outcomes. The prevalence of each outcome will be compared for exposed vs. unexposed pregnancies according to predefined exposure categories using, plausible exposure risk-windows as necessary. Crude and adjusted measures of association will compare the exposed vs the unexposed (prevalence ratios, risk ratios, mortality rate ratios).
Aggregate results from the CPRD UK analyses will be pooled with aggregate results provided by other European Data Access Providers (using a Digital Research Environment) for which CPRD approval has previously been obtained (Query Reference number 00077310).
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Quantifying the role of norovirus transmission dynamics in acute kidney injury hospitalisation trends in England: a population level modelling study — Rosalind Eggo ...
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Quantifying the role of norovirus transmission dynamics in acute kidney injury hospitalisation trends in England: a population level modelling study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-31
Organisations:
Rosalind Eggo - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Hikaru Bolt - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Frank Sandmann - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Acute kidney injury diagnosed in secondary care; Admitted Patient Care. We will define AKI in HES as having a record of at least one AKI ICD-10 N-17 code in any diagnostic position during an admission.
Description: Lay Summary
Acute kidney injury (AKI) is a serious condition where the function of kidneys suddenly decreases. In some countries, the number of hospitalisations due to AKI are higher in the colder winter season, a time when there are many infectious diseases being transmitted between people. One infectious pathogen that might lead to a higher number of AKI hospitalisations in the winter is norovirus, also commonly known as the âwinter-vomiting bugâ. Norovirus causes diarrhoea and vomiting, which may lead to dehydration, which in turn can trigger AKI in people vulnerable to AKI, such as those with chronic kidney disease.
To investigate this relationship further, we will develop a mathematical model representing the spread of norovirus in the community. Using the model we want to see by how much increases in the number of people sick with norovirus leads to increases in AKI hospitalisations. Understanding whether AKI hospitalisations are related to norovirus in the winter is important because a norovirus vaccine will become available soon. If we can demonstrate that winter increases in AKI hospitalisations are related to norovirus in the winter, then the norovirus vaccine may have the potential to prevent norovirus and also reduce the risk of being hospitalised with AKI in vulnerable people. Such additional benefits of vaccination are important to be included for an accurate estimation of the benefits of vaccination for society.
Technical SummaryAKI is a syndrome defined by rapid decline in kidney function leading to disruption in metabolic, electrolyte, and fluid homeostasis. Between 20-25% of hospitalised patients in the UK have AKI, which is associated with a 4-16 fold increase in odds of death. Recent studies have shown that AKI hospitalisations in the UK may have a seasonal pattern, indicating potential associations with communicable diseases such as norovirus. The aim of this project is to quantify to what extent norovirus transmission patterns drive AKI hospitalisation trends. Any association would be an important consideration in future work modelling the health economic impacts of adopting a norovirus vaccination programme in the UK.
Objectives: i) develop a population-level age-structured deterministic compartmental dynamic transmission model for norovirus ii) fit the transmission model to hospitalisation and national norovirus surveillance data
Databases to be used: Hospital Episodes Statistics Admitted Patient Care and CPRD Aurum
Study populations: patients hospitalised with AKI, patients hospitalised with gastroenteritis, patients presenting to primary care for gastroenteritis, patients presenting to primary care for acute kidney injury.
Primary outcome: hospitalisation with AKI.
Exposures: gastroenteritis diagnosed in primary care, gastroenteritis diagnosed in secondary care, age, region.
Study design: population level modelling study.
Data analysis: i) trend analysis of AKI and gastroenteritis hospitalisations over time ii) fitting norovirus transmission model to hospitalisations and primary care trend data using likelihood-based Markov chain Monte Carlo (MCMC) methods to estimate what proportion of norovirus in the community leads to AKI diagnosed in primary and secondary care.
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Risk prediction modelling for gestational diabetes — Nerys Astbury ...
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Risk prediction modelling for gestational diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-07
Organisations:
Nerys Astbury - Chief Investigator - University of Oxford
Nerys Astbury - Corresponding Applicant - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Huiqi Yvonne Lu - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Subhashisa Swain - Collaborator - University of Oxford
Yasmina Al Ghadban - Collaborator - University of OxfordOutcomes:
The primary outcome is a diagnosis of GDM recorded either in the primary care record or in the HES APC data assocated with the delivery.
Secondary outcomes include maternal and neonatal adverse outcomes associated with GDM including:
Outcomes that happen during pregnancy and/or delivery:
GDM Treatment method (including lilfestyle, metformin and insulin)
Gestational weight gain
Hypertensive disorders of pregnancy
Number of antenatal visits/admissions
Still birthDelivery related outcomes:
Mode of delivery (emergency C-section, elective C-section, instrumental delivery)
Perineal trauma/tearing
Induction of labour
Preterm delivery
Length of postnatal stay
Longer-term outcomes:
Development of type 2 diabetes
Return to preâpregnancy weight
Postnatal depression.
Cardiovascular morbidity
Obesity
Recurrent GDMDescription: Lay Summary
Gestational diabetes mellitus (GDM) is high blood sugar that can happen during pregnancy. It's the most common pregnancy complication, affecting about 1 in 7 pregnancies. GDM can increase the risk of pregnancy or delivery complications, and lead to health problems later in life for both the mother and the baby, like being overweight or getting heart disease.
While it's important to detect and treat GDM to avoid complications for both the mother and baby, it can be difficult for healthcare systems to keep up with the demand, especially since it's not always clear who is at risk of developing GDM. If we could accurately predict which women are most likely to develop GDM and experience related complications, we could focus our resources on these groups. This would ensure that everyone gets the attention they need and avoid overwhelming the healthcare system.
The overall aim of the project is to develop tools to identify women who are at risk of developing GDM and facing negative outcomes from it. Data of women with GDM will be extracted from the Clinical Practice Research Datalink electronic health records. These data will be used to identify the factors that contribute to a higher risk of GDM and its negative outcomes, and to build and validate predictive models using different statistical and machine learning methods. The project will help us understand how well we can predict who is at the highest risk using only data available in clinical records.
Technical SummaryThis project aims to develop and validate risk prediction models for gestational diabetes mellitus (GDM) and its adverse outcomes using electronic healthcare records. To develop the prognosis models, a retrospective cohort study design will be used, where information about predictors and outcomes are collected from existing electronic health records. The primary model will determine GDM risk in women with at least one singleton delivery recorded in the healthcare records. The secondary models will focus on the risk of adverse outcomes in women with a GDM diagnosis.
The project will use generalised linear models, support vector machine, random forest, extreme gradient boosting ensemble learning, and deep neural network learning approaches for binary outcomes such as the GDM occurrence; while Cox regression, Cox model with gradient boosting, survival support vector machine, and random survival forest will be used to predict the time-to-event outcomes. A data cleaning pipeline will be developed to filter the outliners and handle missing values. In model development, we will use feature ranking methods such as LASSO regularisation for the GLM, Shapley values for tree-based methods and wrapper methods (backward feature elimination, recursive feature elimination) to increase the interpretability of the models. We will split the dataset into 80:10:10 for model training, testing and validation. The performance of the models will be evaluated using performance metrics for classification and regression models. Bootstrapping and fold-based methods will be used to handle unbalanced data during model testing and hyperparameter tuning. Model calibration, discrimination, and clinical utility will be taken into consideration during the final model selection.
Effective risk stratification is crucial for resource allocation and secondary prevention in the face of the growing prevalence of GDM, which poses a burden on overwhelmed health systems. Accurate detection, treatment, and monitoring can mitigate complications, but identifying at-risk populations remains a challenge.
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Pharmacological treatments during pregnancy associated with the risk of developing short and long-term pregnancy outcomes: signal detection — Anuradhaa Subramanian ...
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Pharmacological treatments during pregnancy associated with the risk of developing short and long-term pregnancy outcomes: signal detection
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-11
Organisations:
Anuradhaa Subramanian - Chief Investigator - University of Birmingham
Jingya Wang - Corresponding Applicant - University of Birmingham
Katherine Phillips - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Megha Singh - Collaborator - University of Birmingham
Siang Ing Lee - Collaborator - University of Birmingham
Steven Wambua - Collaborator - University of BirminghamOutcomes:
A list of core outcomes derived from the ConcePTION and the MuMPredict consortium will be analysed separately.
List of core outcomes from ConcePTION consortium
1) Gestational age at birth (in weeks or days) - ascertained using variable available in linked HES maternity tail data
2) Miscarriage - ascertained using a combination of (1) variable available in linked CPRD Gold Pregnancy Register, (2) Snomed CT codes recorded in CPRD Gold database within 30 weeks from the start of pregnancy (24 weeks + 6 weeks lag period to account for delay in recording) or (3) ICD-10 codes recorded in linked HES data within 30 weeks from the start of pregnancy (24 weeks + 6 weeks lag period to account for delay in recording)
3) Intrauterine death/ stillbirth/ perinatal death - ascertained using a combination of (1) variable available in linked CPRD Gold Pregnancy Register, (2) Snomed CT codes recorded in CPRD Gold database within 48 weeks from the start of pregnancy (42 weeks + 6 weeks lag period to account for delay in recording), (3) ICD-10 codes recorded in linked HES data within 48 weeks from the start of pregnancy (42 weeks + 6 weeks lag period to account for delay in recording) or (4) linked ONS data
4) Small for gestational age (SGA) - All births with birth weight <10th centile for gestational age identified using the INTERGROWTH 21st project, and their software tools, by comparing the birthweight and gestational age recorded in HES data to the international anthropometric standards â both gestational age and birthweight will be ascertained using variables available in HES maternity tail data
5) Preterm birth - All live births between 22 and 37 weeks and still births between 24 and 37 weeks â Gestational age, and still/live birth will be ascertained using variables available in HES maternity tail data
6) Overall Congenital anomalies (CA) â ascertained using a combination of Snomed CT codes recorded in CPRD Gold database for the offspring of the mothers. The patient IDs of the offspring will be obtained from the linked MBL data
7) Specific major congenital anomalies including termination of pregnancy due to foetal anomaly â Specific congenital anomalies with sufficient sample size will be explored as outcomes separately.
8) Maternal death â record of death (1) during pregnancy during pregnancy and within 42 days of the end of pregnancy, and (2) more than 42 days but less than 1 year after the end of pregnancy (late maternal death) â ascertained using linked ONS data*********************************************************************************
Additional list of core outcomes from MuM-PreDiCT consortium
1) Maternal outcomes:
a. Pre-eclampsia, eclampsia, HELLP syndrome - ascertained using a combination of (1) Snomed CT codes recorded in CPRD Gold database between 20 weeks and 48 weeks (42 weeks + 6 weeks lag period to account for delay in recording) from the start of pregnancy or (3) ICD-10 codes recorded in linked HES data between 20 weeks and 48 weeks (42 weeks + 6 weeks lag period to account for delay in recording) from the start of pregnancy
b. Placenta abruption - ascertained using a combination of (1) Snomed CT codes recorded in CPRD Gold database between 20 weeks and 48 weeks (42 weeks + 6 weeks lag period to account for delay in recording) from the start of pregnancy or (3) ICD-10 codes recorded in linked HES data between 20 weeks and 48 weeks (42 weeks + 6 weeks lag period to account for delay in recording) from the start of pregnancy
c. Venous thromboembolism - 1) Snomed CT codes recorded in CPRD Gold database between start of pregnancy and 54 weeks (42 weeks + 12 weeks lag period to account for delay in recording) from the start of pregnancy or (3) ICD-10 codes recorded in linked HES data between start of pregnancy and 54 weeks (42 weeks + 12 weeks lag period to account for delay in recording) from the start of pregnancy
d. Preterm premature rupture of membrane â ascertained using ICD-10 codes recorded in linked HES maternity tail records around the time of delivery for preterm births
e. Severe maternal morbidity â Composite a morbidities as included in the CDC definition: (1) Acute myocardial infarction, (2) Aneurysm, (3) Acute Renal Failure, (4) Adult respiratory distress syndrome, (5) Amniotic fluid embolism, (6) Cardiac arrest or ventricular fibrillation, (7) Disseminated intravascular coagulation, (8) Eclampsia, (9) Heart failure or arrest during surgery or procedure, (10) Puerperal cerebrovascular disorders, (11) Pulmonary edema or Acute heart failure, (12) Severe anesthesia complications, (13) Sepsis, (14) Shock, (15) Sickle cell disease with crisis, (16) Air and thrombotic embolism, (17) Conversion of cardiac rhythm, (18) Blood products transfusion, (19) Hysterectomy, (20) Temporary tracheostomy, (21) Ventilation â ascertained using ICD-10 codes or OPCS codes recorded in linked HES data after 3 months from the time of delivery
f. Postpartum haemorrhage â ascertained using ICD-10 codes recorded in linked HES data between the time of delivery and 3 months from delivery to account for secondary PPH
g. Self-harm/suicide â ascertained using a combination of ICD-10 codes and Snomed CT codes recorded in linked HES data and CPRD Gold Primary care data respectively during: (1) antenatal period, (2) 0-3 months post pregnancy end date, (3) 3-6 months post pregnancy end data and (6-12 months post pregnancy end date. In addition, this will be ascertained using linked ONS data
2) Childrenâs outcomes
a. Cerebral palsy - ascertained using a Snomed CT codes recorded in CPRD Gold database for the offspring of the mothers. The patient IDs of the offspring will be obtained from the linked MBL data
b. Neurodevelopmental conditions - ascertained using a Snomed CT codes recorded in CPRD Gold database for the offspring of the mothers. The patient IDs of the offspring will be obtained from the linked MBL dataDescription: Lay Summary
Polypharmacy refers to people taking two or more different medications at the same time. It has been increasing over the last 30 years, including in the pregnant women and birthing people. Side effects are possible for anyone taking prescription medicine and can be a bigger issue for people who are taking multiple medicines. There are also potential problems caused by the interaction between different medications.
Technical Summary
We donât have a good understanding of how much polypharmacy affects pregnant women and their babies, but itâs known that the changes that occur in the body during pregnancy mean that medications may not have the same effect as they do in someone who is not pregnant. The main reason for this lack of knowledge is that new medication is rarely tested on pregnant women due to concerns about the possible impact on the unborn baby. Using real-world data about women who have taken medications in pregnancy is a useful way to overcome this problem.
Our study will compare women/offspring who have had different pregnancy-related complications with those who hadnât. We will investigate whether certain combinations of medications are more or less likely to have been prescribed in women with these complications. Findings will be discussed with researchers and clinicians to find drugs which should be investigated more rigorously.
Knowing the potential benefits and harms of consuming medications during pregnancy will help pregnant women and their health care professionals to make informed decisions about whether or not to continue or start medications in pregnancy.Aims: Considering the high prevalence of polypharmacy in pregnant women and the knowledge gap in the risk-benefit safety profile of their often-complex drug regimens, more research is needed to optimise prescribing. This study aims to conduct a pharmacovigilance study to assess the effect of medications prescribed during the preconception period (3 months prior to conception) and first trimester of pregnancy.
Methods/design: A series of case control studies will be conducted to estimate measures of disproportionality (such as odds ratios from a series of logistic regression models), detecting signals of association between a range of pregnancy, delivery and offspring outcomes and exposure to individual and combinations of drugs.
Outcome: The MuM-PreDiCT and ConcePTION consortium have developed core outcome sets (a minimum set of recommended maternal and offspring outcomes) for studies of pregnant women with multiple long-term conditions.
Exposures: All medications prescribed within primary care, coded using the Dictionary of Medicines and Devices (DM+D) have a BNF item code associated with them. All the medications included in the dictionary will be used in the analysis excluding non-pharmacological agents such as dressing. Medications prescribed will be stratified according to their BNF item code (BNF chapter, section, paragraph and sub-paragraph) and by two crucial time windows: 1) preconception period; 2) first trimester of pregnancy.
Participants: Women aged between 15-49 years with a pregnancy recorded within the Pregnancy Register between 1st Jan 2000 and 31st July 2022 will be eligible when exploring pregnancy outcomes. Women who are further eligible for linkage to HES record, and have a record of delivery within the HES maternity tail will be eligible when exploring delivery outcomes. Furthermore, women linked to their baby records within primary care using mother-baby linked data will be eligible when exploring offspring outcomes.
Covariates: Demographic and health characteristics will be adjusted to account for confounding.
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Early immunization for influenza and the risk of neurodegenerative disease — Samy Suissa ...
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Early immunization for influenza and the risk of neurodegenerative disease
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-25
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Paul Brassard - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill University
Ying Cui - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Dementia, Parkinsonâs disease
Description: Lay Summary
The global population is ageing. Dementia and Parkinsonâs disease are diseases that are common among older adults. Therefore, the number of patients with these two diseases is about to strongly increase in the next decades. Dementia is characterized by the impaired ability to remember, think, or make decisions. It interferes with doing everyday activities. Parkinsonâs disease is a brain disorder that causes unintended or uncontrollable movements, such as shaking and stiffness. It also causes difficulty with balance and coordination. To date, there has been a lack of effective treatment options for both diseases. Prior studies have suggested that influenza, a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs, may increase the risk of dementia and of Parkinsonâs disease. Therefore, influenza vaccines earlier in life could lower the risk of developing dementia and Parkinsonâs disease later. However, the quality of the studies in the area is limited. Moreover, these studies focused on vaccinations in older adults. Using a large database from the United Kingdom, we will compare the rates of dementia and of Parkinsonâs disease between people with and without vaccination for influenza between 40 and 50 years of age. We hope that the findings from this study will provide needed insight on the role of influenza vaccinations in dementia and Parkinsonâs disease. This would then inform the development of vaccination programs to reduce the number of patients affected by these diseases.
Technical SummaryGiven the ageing population, the prevalence of dementia and Parkinsonâs disease (PD) is projected to increase in the upcoming years. Previous pre-clinical and observational studies have suggested that past infections such as influenza play a role in the pathophysiology of these conditions. Therefore, immunizations for influenza could have beneficial effects regarding the prevention of neurodegenerative diseases later in life. However, available evidence in this regard is limited. On the one hand, prior observational studies on the effects of influenza vaccines on the risk of dementia or PD had several methodological limitations. On the other hand, these studies focused on immunizations occurring later in life. This precludes conclusions on their potential effects when occurring earlier in life, when the pathophysiologic cascade that ultimately leads to neurodegenerative diseases has not yet begun. Our hypothesis is that early immunizations for influenza could be associated with decreased risks of dementia and PD. To investigate these potential associations, we will conduct a cohort study including all patients in the United Kingdomâs Clinical Practice Research Datalink (CPRD) Aurum between 40 and 50 years of age from 1 January 1996 to 31 December 2022. Each individual receiving an influenza vaccine will be matched 1:1 on calendar month, age, sex, and CPRD general practice to individuals not exposed to the influenza vaccine. Using a modified intention-to-treat exposure definition with a two-year lag period, we will compare the risk of dementia and PD between exposed and unexposed individuals. Cox proportional hazards models will calculate hazard ratios and 95% confidence intervals, adjusted for confounders at baseline. In secondary analyses, we will assess potential effect modifications by age, sex, number of influenza vaccines, time since first influenza vaccine, and seasonality. Sensitivity analyses will assess the potential impact of different sources of bias.
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Levothyroxine and the risk of arrhythmias among patients with mild subclinical hypothyroidism: a population-based cohort study — Samy Suissa ...
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Levothyroxine and the risk of arrhythmias among patients with mild subclinical hypothyroidism: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-07
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Bianca Bianchini - Collaborator - Federal University of Rio Grande do Sul - UFRGS
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
James Brophy - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Tatiane da Silva Dal Pizzol - Collaborator - Not from an OrganisationOutcomes:
The primary outcome will be the first occurrence of any clinically-relevant arrhythmia, a composite endpoint that includes atrial fibrillation, atrial flutter, ventricular tachycardia, and sudden cardiac death. Secondary outcomes will be the individual components of this composite endpoint.
Description: Lay Summary
Subclinical hypothyroidism is a condition characterized by abnormal thyroid hormone levels. It is known to increase the chances of having heart attacks and dying. It is also possible that it increases the chances of having heart-related rhythm disorders, called arrhythmias. Levothyroxine replacement therapy is used to treat subclinical hypothyroidism, but its use is not widely recommended for all patients with this condition. Studies suggest a potential relationship between levothyroxine use and the risk of arrhythmia, but this potential side effect has not been thoroughly investigated. The proposed study aims to evaluate this relationship using the electronic health records of patients with subclinical hypothyroidism. We will compare the occurrence of clinically-relevant arrhythmias among patients who received levothyroxine and those who did not. We will investigate the risk of clinically-relevant arrhythmias overall and different types of arrhythmias. The findings of this study will contribute to our understanding of the relationship between levothyroxine and arrhythmias among patients with subclinical hypothyroidism.
Technical SummaryMild subclinical hypothyroidism (SCH) is defined by a serum thyroid-stimulating hormone (TSH) above reference ranges with normal free thyroxine (FT4) levels. SCH has been associated with an increased risk of cardiovascular events and mortality. In this context, the association between SCH and cardiac arrhythmias has been investigated, but the risk remains unclear. Levothyroxine is a drug considered for the treatment of SCH; however, unlike for patients with overt hypothyroidism, its use is not widely recommended for all patients with mild SCH. Epidemiological studies have suggested that there may be a causal relationship between levothyroxine use and the risk of arrhythmias that is mediated by TSH and FT4 levels, but this relationship remains poorly understood. We will conduct a retrospective cohort study to evaluate the association between levothyroxine use among people with mild SCH and the risk of clinically-relevant arrhythmias (atrial fibrillation, atrial flutter, ventricular tachycardia, and sudden cardiac death). This study will include all patients with mild SCH using the Clinical Practice Research Datalink Aurum, which will be linked to Hospital Episode Statistics Admitted Patient Care data and Office for National Statistics vital statistics. Using a prevalent new user design, we will match each patient who receives levothyroxine to someone who did not, on age, sex, duration of SCH history, history of cardiovascular disease, calendar time, and time-conditional propensity scores. The primary outcome will be the first occurrence of any clinically-relevant arrhythmia. Secondary outcomes will be atrial fibrillation, atrial flutter, ventricular tachycardias, and sudden cardiac death. We will use Cox proportional analysis to estimate hazard ratios for arrhythmia between patients who received levothyroxine versus those who did not. In secondary analyses, we will examine the mediating role of TSH and FT4 levels and determine if the relationship between levothyroxine and arrhythmias varies with dose, age, sex, and cardiovascular disease history.
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Exploring veterans physical and mental health needs: the use of the Clinical Practice Research Datalink — Sharon Stevelink ...
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Exploring veterans physical and mental health needs: the use of the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-24
Organisations:
Sharon Stevelink - Chief Investigator - King's College London (KCL)
Gemma Archer - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Natalia Kika - Collaborator - King's College London (KCL)
Nicola Fear - Collaborator - King's College London (KCL)Outcomes:
Primary outcomes: depression; anxiety; psychosis; schizophrenia; suicidal ideation; post-traumatic stress disorder; TBI; addictions (including alcohol); cardiovascular conditio ns, musculoskeletal conditions; hearing loss; cancer; diabetes; dementia; and Parkinson disease.
Secondary outcomes: main medication prescriptions (e.g., antihypertensives; psychotropics; opiates) ; and healthcare utilisation (e.g., inpatient admissions; specialist referrals; primary care consultations).
PROVE validation study outcomes: Veteran status validation with GP practice records in sub-sample of 100 patients (n=10 GP practices x 10 patients). The validation outcome will be concordance between CPRD data and GP records on: number of veterans registered at GP practice, veterans status, date veteran status recorded, and recorded Service branch information (appendix 3).
Description: Lay Summary
Background
We know veterans (those who served in the Armed Forces and have now left) are more likely to face complex co-occurring physical and mental health problems, yet little is known about veterans' health outcomes and their use of health services. This is important because there are numerous services for veterans' mental health needs, but very few services tailored to address veteransâ physical health needs, or those with more complex health problems. A cost and time-effective way to increase our understanding about veterans accessing primary care is to examine primary care (General Practice) records. To address these challenges, we propose to explore the utility and feasibility of the Clinical Practice Research Datalink (CPRD) for veteransâ health research, and specifically, to determine and characterise the physical and mental health outcomes of veterans.Methods
CPRD provides anonymised data from 60 million patients who have accessed primary care services across the UK. Initial investigations by our team, suggest that we will have access to data from approximately 70,000 veterans. We will also determine a group of non-veterans within the CPRD data to make comparisons.Anticipated impact
Technical Summary
This project will aid our understanding about the value of using CPRD as an additional data source for veteransâ health research, particularly exploring the profile and long-term health outcomes of veterans within the UK healthcare system. Currently, we have limited knowledge about the health needs of veterans accessing primary care and the proposed study has the potential to play a key role in addressing this.Aims: 1) To examine the feasibility and utility of using the Clinical Research Practice Datalink (CPRD) for veteransâ health research, and 2) To determine and characterise the physical and mental health outcomes of veterans and explore whether they are different to a non-veteran comparison group.
Primary exposures: Veteran status, GP veteran accreditation status
Covariates: Socio-demographic characteristics (age, sex, ethnicity, Index of Multiple Deprivation*, area of residence), lifestyle behaviours (smoking, physical activity, obesity), co-prescribing
Outcomes: Common physical and mental disorders: depression, anxiety, psychosis, schizophrenia, suicidal ideation, post-traumatic stress disorder, TBI, addictions (including alcohol), cardiovascular conditions, musculoskeletal conditions, hearing loss, cancer, diabetes, dementia, Parkinson disease are the primary outcomes of interest (classified using medical codes, SNOMED, Read). Medication prescriptions (e.g., antihypertensives, psychotropics, opiates), and healthcare utilisation (e.g., inpatient admissions, specialist referrals, primary care consultations) are secondary outcomes. For a subsample of patients, cancer and common physical and mental disorder data will be complemented with information from the HES Admitted Patient Care (HES APC) dataset.
Study design: Prospective matched cohort study.
Methods: Descriptive statistics to explore differences in primary exposures and outcomes of interest. Subsequently, time to event analyses will be conducted (e.g. Cox regression, Poisson) to compare differences in the incidence in the outcomes of interest, among veteran patients compared to a non-veteran comparison group.
Linked datasets: Index of Multiple Deprivation (patient level)*, HES Admitted Patient Care (HES APC).
Findings: This study will help us to understand whether CPRD is a useful data source for veteransâ health research. In addition, the results will help us to understand the incidence and prevalence of health disorders among veterans, how this compares to non-veterans and their healthcare utilisation.
*Index of Multiple deprivation will be used in analyses as a potential confounder and effect modifier in associations between veteran status and health.
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Mental health of mothers of children with special educational needs or disabilities (SEND) in the UK before and during the COVID-19 pandemic. — Luke Mounce ...
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Mental health of mothers of children with special educational needs or disabilities (SEND) in the UK before and during the COVID-19 pandemic.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-04
Organisations:
Luke Mounce - Chief Investigator - University of Exeter
Luke Mounce - Corresponding Applicant - University of Exeter
Gretchen Bjornstad - Collaborator - University of Exeter
Sarah Bailey - Collaborator - University of Exeter
Sarah Walker - Collaborator - University of Exeter
Tamsin Newlove-Delgado - Collaborator - University of ExeterOutcomes:
The outcome will be prevalence of mental health disorders in mothers of children with SEND (cases) and children without SEND (controls). This will be assessed at the patient-level with a binary indicator for presence of a mental health condition.
The following mental health conditions will be considered:
⢠psychosis (affective and non-affective, including bipolar)
⢠depressive disorders
⢠anxiety disorders (including PTSD)
⢠eating disorder (anorexia and bulimia)
⢠personality disorder
⢠substance and alcohol dependence.We will also include referrals to mental health related secondary care outpatient services or inpatient psychiatric stays as indicating the presence of mental health conditions.
Time period will be defined as follows:
Year 0: 01/07/2018 - baseline
Year 1: 01/07/2019 - change in 1 year without a pandemic
Year 2: 01/07/2020 - as first COVID-19 lockdown ends
Year 3: 01/07/2021 - restrictions lifting
Year 4: 01/07/2022 - no ongoing restrictionsDescription: Lay Summary
Many parent carers of children with special educational needs or disability struggle with their mental health. In this study, we want to find out whether mothers of children with special educational needs or disability in England are more likely to have mental health conditions than other mothers, and whether this problem has worsened since the start of the COVID-19 pandemic.
We will be looking at health data to see how many parent carers have mental health conditions such as depression, anxiety and addiction. We will also investigate whether ethnicity, physical health, or complications at their childâs birth mean that they are more likely to need support for their mental health. We will look at how the COVID-19 pandemic has affected mothersâ mental health by comparing data from before and during the pandemic, as well as after the lifting of restrictions in 2022. We will also compare the number of mental health diagnoses mothers have according to which special educational needs or disability their child is diagnosed with.
This research will help us to understand the challenges that parent carers face with mental health conditions. This will mean that more research can be done to find ways to help and support parent carersâ mental health.
Technical SummaryBackground:
Parent carers of children with special educational needs or disabilities (SEND) in England are likely to have high rates of mental health conditions and an unmet need for support and treatment for their mental health. In addition, parent carers are likely to have been disproportionately affected by the pandemic due to changes in education and support during COVID-19.Aims:
To examine the prevalence of mental health conditions, specifically depression, anxiety, post-traumatic stress disorder (PTSD), and addiction among mothers of children with SEND in the UK, before and during the COVID-19 pandemic, compared to mothers of children without SEND.To explore change (increase or decrease) in the number of maternal mental health conditions between adjacent annual time points and from baseline to each subsequent time point.
To compare the prevalence of maternal health disorders across SEND conditions in children. We will also consider the association between premature births or birth complications and maternal mental health.
Methods:
We will use a retrospective cohort design using the Clinical Practice Research Datalink (CPRD). We will investigate whether the prevalence of mental health disorders in mothers is impacted by their ethnicity, socio-economic deprivation, and physical health conditions. Additionally, we will investigate the effect of birth complications (including pre-term birth).Anticipated outputs and impact:
This project contributes to a larger study which is compiling information about the need and access to mental health services for parent carers, including the impact of the pandemic and regional variation (using the geographical region of GP practice). We plan for this project to lead to further research to develop and test strategies to overcome barriers to accessing evidence-based mental health treatment for parent carers with mental health conditions. The ultimate intention is to benefit the mental health and wellbeing of parent carers and their families.
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Age at first diagnosis among people with severe mental illness, and related inequalities in England: a population-based cohort study using primary care (CPRD) data — Sheena Ramsay ...
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Age at first diagnosis among people with severe mental illness, and related inequalities in England: a population-based cohort study using primary care (CPRD) data
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-27
Organisations:
Sheena Ramsay - Chief Investigator - Newcastle University
Ziyi Cai - Corresponding Applicant - Newcastle University
David Sinclair - Collaborator - Newcastle University
Emma Adams - Collaborator - Newcastle UniversityOutcomes:
Age at first diagnosis of SMI in primary care records (CPRD Aurum dataset)
Description: Lay Summary
Several studies have suggested that early intervention could lead to better treatment outcomes, improve social function and quality of life for people with mental illness. Early diagnosis is the first step towards early intervention. This study aims to examine the age at which people with severe mental illness (SMI) are more likely to have a first diagnosis in primary care in England. In addition, it is possible that age at first diagnosis of SMI differs across the population, most likely due to the difference in risk and access to care between different populations. This study will investigate whether there are social inequalities and variations in age at diagnosis of SMI in different social groups (e.g. gender, geographical regions of England, urban/rural regions, socioeconomic deprivation, ethnicity). Results from this study would help increase the understanding of the timing of diagnosis of SMI and add to the understanding on inequalities in the diagnosis of SMI in England. These findings will provide important recommendations for policy and practice to develop and deliver early intervention strategies for people with SMI.
Technical SummaryThe overarching aim of this study is to improve the understanding of key time points of early interventions for people with SMI in England based on specific social contexts. This study is a retrospective study. The study population would be a cohort of individuals with SMI recorded in the CPRD Aurum dataset. Area-level linked data will also be used to determine socioeconomic deprivation of patients. The main outcome of this study is the age at first diagnosis of SMI. Descriptive analysis will be performed to estimate the peak age at recorded diagnosis of SMI overall, and according to relevant subgroups of populations. Linear regression models or multilevel regression models will be applied to investigate the associations between different levels of social inequalities (e.g. gender, geographical regions of England, urban/rural regions, socioeconomic deprivation, ethnicity) and age at recorded diagnosis for people with SMI in primary care. Estimates of age at first diagnosis of SMI and related variations by subgroups would point to potential opportunities for providing more targeted and equitable services for people with SMI.
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Does the maternal GP check at six weeks postpartum play a role in improving outcomes for women with epilepsy? — Claire Carson ...
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Does the maternal GP check at six weeks postpartum play a role in improving outcomes for women with epilepsy?
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-03
Organisations:
Claire Carson - Chief Investigator - University of Oxford
Kate Fitzpatrick - Corresponding Applicant - Nuffield Department of Population Health
Aden Kwok - Collaborator - University of Oxford
Chris Gale - Collaborator - Imperial College London
Dimitrios Siassakos - Collaborator - University College London ( UCL )
Fiona Alderdice - Collaborator - University of Oxford
Julia Sanders - Collaborator - Cardiff University
Maria Quigley - Collaborator - University of Oxford
Sara Kenyon - Collaborator - University of Birmingham
Yangmei Li - Collaborator - University of OxfordOutcomes:
Receipt of postpartum care:
Maternal six-week postpartum check (SWC);
Other postnatal care with GP, e.g. contraception advice, BP check, physical examination;Impact on postpartum outcomes (not epilepsy specific)
Prescribed contraception: prescriptions for female prophylactic contraception (long-term e.g. implant and intrauterine device or contraceptive pill) and emergency contraception (levonorgestrel or ulipristal acetate);
Subsequent conception <12 months after giving birth;
Urinary and/or faecal incontinence;
Postpartum depression and/or anxiety
Dyspareunia, painful intercourse, perineal/pelvic painImpact on postpartum outcomes (epilepsy specific)
Unplanned hospital admission for epilepsy;
A&E visit for epilepsy;
Mortality
No recording of pregnancy prevention plan in GP records for women prescribed sodium valproateDescription: Lay Summary
Women in England should receive a check-up with their GP 6-8weeks after giving birth. This âsix-week checkâ should focus on the motherâs mental health and general wellbeing, their return to physical health, family planning and contraception, and any conditions that existed before or arose during pregnancy that may need further care. Recent research has found that more than a third of women are not getting a six-week check. However, we do not know if women who have other health problems are more or less likely to get their six-week check, or if this check improves their health longer term.
Epilepsy is a brain disorder that causes frequent seizures. Seizures are sudden bursts of electrical activity in the brain that can cause temporary changes in behaviour, movements, feelings and levels of consciousness. This study explores whether women with epilepsy are more or less likely than a group of women without epilepsy from the general population who have recently given birth to receive their six-week check. We will find out if any differences in the likelihood of receiving a six-week check between these women can be explained by differences in their characteristics such as their age, ethnicity, and where they live. We will then examine whether receiving a six-week check affects the chance of epileptic women using contraception or having health problems detected or treated in the first year after giving birth. This will help us understand whether receiving a six-week check plays a role in improving outcomes for women with epilepsy.
Technical SummaryWhile a maternal postpartum six-week check (SWC) with a GP has long been recommended, it only became an essential service in 2020. However, there is limited evidence for the effectiveness of the SWC in improving womenâs longer-term health and wellbeing. This study aims to describe the provision of the maternal postpartum SWC in a specific high-risk group, women with epilepsy, and whether receiving a check is associated with improved outcomes in the first year postpartum.
The CPRD-Aurum pregnancy register and Hospital Episode Statistics will be used to create a cohort of pregnancies ending in a live birth or stillbirth between 1998-2022 to women with epilepsy along with a random population sample of pregnancies ending in a live birth or stillbirth over the same period to women without epilepsy. Descriptive analyses will assess the prevalence of the SWC among the women with and without epilepsy. Modified Poisson regression will be used to investigate if any inequity in the provision of the SWC between these women can be explained by differences in their characteristics. Appropriate regression approaches (e.g.logistic regression for rare binary outcomes or survival analysis approach to allow for follow-up time and take account of censoring) will then be used to examine if the women with epilepsy are more or less likely than the women without epilepsy to be prescribed contraception or have adverse outcomes detected/treated in the postpartum period, and to examine if this is influenced by receiving a SWC. Regression approaches will also be used to examine, in the women with epilepsy only, whether receiving a SWC influences the subsequent likelihood of having contraception prescribed or adverse outcomes detected/treated in the postpartum period.
This will provide evidence for policy makers with regard to the needs of women with epilepsy, as a step towards improving postpartum care for these women.
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Antidiabetic drug utilisation after COVID-19 infection amongst patients with diabetes mellitus type 2: a retrospective cohort study from the UK — Olaf Klungel ...
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Antidiabetic drug utilisation after COVID-19 infection amongst patients with diabetes mellitus type 2: a retrospective cohort study from the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-04
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Shahab Abtahi - Corresponding Applicant - Utrecht University
Eveline de Waard - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht UniversityOutcomes:
We will define four drug utilisation outcome categories: 1) monotherapy with one non-insulin antidiabetic drugs (NIADs); 2) treatment with â¥2 NIADs; 3) treatment with insulin, with or without NIAD; and 4) no antidiabetic treatment, based on the National Institute for Health and Care Excellence (NICE) guideline for the management of T2DM in the UK.1
Description: Lay Summary
Coronavirus disease 2019 (COVID-19) was first reported in Wuhan, China, in December 2019 and declared to be a pandemic by the World Health Organisation in March 2020. It has so far claimed millions of lives around the world, but also affected other diseases and patient groups in many different ways. Previous studies have shown that COVID-19 might impact the course of diabetes (sugar disease) and the need for glucose-lowering treatment. However, the relation between COVID-19 and utilisation of glucose-lowering drugs is not yet clear.
Technical Summary
In this study we assess the effect of COVID-19 infection on use of glucose-lowering drugs for up to one year in patients with diabetes. This will include the use of both insulin and non-insulin glucose-lowering drugs. We will also study the effect of COVID-19 infection on pattern of use of glucose-lowering drugs (starting, stopping and switching drugs), and any change in the daily dose of various glucose-lowering drugs.
By answering to our research question, we will have a better understanding of the effects of COVID-19 infection on use of glucose-lowering drugs among patients with diabetes. This will be of interest for both patient care and policy making, at a time when COVID-19 pandemic has had a huge impact on the healthcare systems and our societies.Coronavirus disease 2019 (COVID-19) might influence the course of type 2 diabetes mellitus (T2DM) and raise the need for antidiabetic treatment. However, this association remains unclear to date. We aim to investigate the effect of COVID-19 infection on antidiabetic drug utilisation for up to one year in patients with T2DM.
This will be a retrospective population-based cohort study with data from the Clinical Practice Research Datalink (CPRD) GOLD database. Patients over the age of 18 with T2DM will be included between 1 September 2020 and 31 March 2021 and followed up for a maximum of 12 months. Our exposure of interest will be a confirmed or (highly) suspected COVID-19 diagnosis, and T2DM patients with a COVID-19 diagnosis will be matched with up to 4 T2DM patients unexposed to COVID-19 ever before. We will define drug utilisation outcome categories of non-insulin antidiabetic drugs (NIADs) and insulin. Multinomial logistic regression models will estimate the odds ratio of using â¥2 NIADs, insulin +/- NIAD, or no antidiabetic treatment, compared with 1 NIAD, in T2DM patients with COVID-19 versus those without, during the short (0-3 months), medium (4-6 months) and long (7-12 months) terms after the index date (i.e., COVID-19 diagnosis date). Also, the pattern of antidiabetic drug use (i.e., initiating, stopping, or switching) will be assessed between the two exposure groups. In secondary analyses, the average daily dose of insulin and a select of common and important NIADs (metformin and most common sulphonylurea, dipeptidyl peptidase-4 inhibitor, and sodium-glucose cotransporter-2 inhibitor in use) will be compared between the exposure groups in short, medium- and long-terms after the index date. The regression models will be adjusted for relevant lifestyle factors, comorbidities and relevant other drug exposures.
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Cardiovascular outcomes of gout flares and treat-to-target urate lowering treatment. — Abhishek Abhishek ...
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Cardiovascular outcomes of gout flares and treat-to-target urate lowering treatment.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-21
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Edoardo Cipolletta - Corresponding Applicant - University of Nottingham
Anthony Avery - Collaborator - University of Nottingham
Georgina Nakafero - Collaborator - University of Nottingham
Laila Tata - Collaborator - University of Nottingham
Mamas Mamas - Collaborator - Keele UniversityOutcomes:
Outcomes:
Objective 1 (cardioprotective effect of ULT) and Objective 2 (cardioprotective effect of colchicine):
[a] incident cardiovascular event (primary-outcome),
[b] death due to cardiovascular events (secondary-outcome),
[c] number of primary-care consultations for cardiovascular events,
[d] number of hospitalizations for cardiovascular events.
Definition: primary care diagnosis of stroke and/or acute myocardial infarction, hospitalisation with a primary discharge diagnosis of stroke and/or acute myocardial infarction, death with stroke and/or acute myocardial infarction as the cause of death. Linkage across all databases will be used to improve case ascertainment as 25-50% of cardiovascular events are not recorded in at least one of the three data sources [3].Objective 3 (gout flare and other cardiovascular events):
[a] cardiac arrhythmias (atrial fibrillation, ventricular tachycardia, ventricular fibrillation, atrioventricular blocks, bradyarrhythmias, placement of pacemaker).
Defined as primary care diagnosis of arrhythmias, hospitalisation with a primary discharge diagnosis of arrhythmias or death with arrhythmias as the cause of death.
[b] hospitalisation for decompensated heart failure, defined as primary discharge diagnosis of heart failure.Description: Lay Summary
Gout is caused by high levels of urate, which is a normal waste product but if too high, can remain as urate crystals inside joints. When a build-up of crystals is shed, it causes pain and swelling, called gout flares. People with flares can have a higher risk of heart attacks and strokes. It is not known if gout flares are also linked with heart failure and irregular heartbeat.
Technical Summary
Medicines like allopurinol reduce urate and dissolve crystals, reducing gout flares. Anti-inflammatory medicines like colchicine also prevent gout flares. Whether these medicines also reduce the risk of heart attack and stroke in people with gout is unknown.
This study will find out if people treated with allopurinol who have well-controlled low levels of urate and those treated with colchicine also have the benefits of a lower risk of experiencing heart attack or stroke. It will also find out if gout flares are associated with other heart diseases such as irregular heartbeat and heart failure and if the use of medicines can help lower any increased risks.
The study will use clinical information from over 90 thousand people with gout. It will use routinely collected information from their general practice, hospital, and mortality records obtained from the Clinical Practice Research Datalink (CPRD) and linked to hospitalisation and mortality records.
This project will improve gout care by highlighting the adverse effects of gout flares on peopleâs health and the benefits of medicines that lower uric acid. Consequently, these results will improve gout treatment.Background: People with gout have high cardiovascular disease risk. Long-term treat-to-target urate-lowering therapy (T2T-ULT) prevents gout flares. Whether lowering serum urate with T2T-ULT will prevent cardiovascular events has not been investigated. Additionally, whether gout flares are associated with arrhythmias and decompensated heart failure is unknown.
Objectives: The objectives are to evaluate among people with gout whether: [1] T2T-ULT that meets serum urate target recommended in NICE guidelines (i.e. <360 µmol/L) reduces cardiovascular event risk, [2] colchicine flare prophylaxis co-prescribed with ULT reduces cardiovascular event risk, and [3] whether gout flares are associated with subsequent cardiac arrhythmias, heart failure and are potential risks modified with well controlled urate levels from treatment with ULT and colchicine.
Methods: The study will be delivered in three parts.
Data source: Routinely collected healthcare data from the Clinical Practice Research Datalink (CPRD) linked with socioeconomic deprivation, hospitalisation and mortality records will be used.
Objective-1: Using a cohort of incident gout patients prescribed ULT for the first time, landmark analysis in a cohort study design will be used to compare hazard ratios of future cardiovascular events and rate ratio of number of healthcare utilizations for cardiovascular events in patients meeting and not meeting serum urate treatment target recommended in NICE guidelines within 12 months of the start of ULT.
Objective-2: Using the cohort of incident gout cases prescribed ULT for the first time, hazard ratios of cardiovascular events and rate ratio of the number of healthcare utilizations for cardiovascular events will be compared between those co-prescribed colchicine flare prophylaxis and age-sex-matched comparisons not co-prescribed colchicine flare prophylaxis in a cohort study.
Objective-3: Data from CPRD will be used to conduct two separate nested case-control studies and self-controlled case series analyses to investigate the association between gout flares and subsequent cardiac arrhythmias, and heart failure.
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Describing the association between ursodeoxycholic acid adherence and positive COVID-19 diagnosis in primary care in the United Kingdom — Simon Wan Yau Ming ...
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Describing the association between ursodeoxycholic acid adherence and positive COVID-19 diagnosis in primary care in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-17
Organisations:
Simon Wan Yau Ming - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Simon Wan Yau Ming - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Mike Smith - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitasOutcomes:
The outcomes that are measured are described in CPRD Aurum SARS-CoV-2 code list provided in the CPRD data highlights.
Positively tested/diagnosis of COVID-19 include codes that cover 'code types' that include 'Diagnosis', 'Tested/Diagnosis'. 'Possible', 'Tested', 'Vaccination' and 'Advice' will not be considered as a positive diagnosis. Codes for these code types are provided in reference 9. Incidence of tested/diagnosis and diagnosis will be considered as a single outcome indicating positive diagnosis. Time until diagnosis will not be considered.Description: Lay Summary
The Covid-19 pandemic resulted in significant amount of illness and death worldwide. During the pandemic, governments instituted lockdowns, widespread testing and vaccination. Several new drugs were proposed to prevent Covid-19 infection, with four newly developed drug therapies being approved in the UK for prevention of severe disease in those who are at most risk. These drugs have been developed at high cost hence the restriction to those who are most likely to benefit.
Technical Summary
Ursodeoxycholic acid (UDCA) has been investigated as a possible drug with the potential to prevent Covid-19 in people. UDCA is an inexpensive drug prescribed in those suffering with stones from the gallbladder or those with a condition called primary biliary cirrhosis, which is a liver disease caused by the body's immune system attacking the ducts that drain bile from the liver. UDCA is generally safe and well tolerated. The possibility that it may prevent Covid-19 has resulted in widespread use in China where public concern due to Covid-19 is still high due to less vaccination coverage in the elderly and fewer intensive care beds per head of population. The effectiveness of UDCA in preventing Covid-19 has not been widely investigated but has the potential of being an inexpensive preventative medication. Studying this in a restricted real life population will help investigate whether there is rationale behind UDCA use for persons concerned about Covid-19 infections.This study aims to study the association between adherence to UDCA prescriptions and the incidence of Covid-19 as documented in primary care.
The study population of interest includes patients that have been recorded as having been prescribed UDCA during the study period. The primary exposure is adherence to UDCA as measured by the proportion of days covered, calculated by the length of the prescription in days divided by the days within the study period. This selection represents patients with similar health conditions that require treatment with UDCA and allows for patients with no prescriptions during the study period to be part of the study population.
This study will take place over 2 outcome phases. 1) 30 June 2020 to 31 December 2020 corresponding to the start of the pandemic and pre-vaccination. 2) 1 July 2020 to 30 May 2021 corresponding to the start of vaccinations to lifting of outdoor restrictions lifted to allow 30 people to mix.
Eligible patients will need to be registered prior to the start of the study period. Patients who register after the start of the study period will not be eligible. Patients who become unregistered or have a death date after the start of the study period will be included.
The study will be a comparative retrospective cohort study where the exposure will both be considered as a continuous (adherence as measured by the proportion of days covered) and categorical (low adherence, high adherence, with the boundary of 80% or over as the differentiator for high adherence) measure.
The recording of COVID-19 within the primary care record will be the primary outcome and will be tested with logistic regression analysis taking into account other covariates that have been listed by the NHS as increasing susceptibility to the Covid-19 virus will be included as confounders.
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Evaluating the risk of disability progression, frailty, macrovascular events, and mortality in individuals with multiple sclerosis in England: a population-based retrospective cohort study — Raffaele Palladino ...
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Evaluating the risk of disability progression, frailty, macrovascular events, and mortality in individuals with multiple sclerosis in England: a population-based retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-11
Organisations:
Raffaele Palladino - Chief Investigator - Imperial College London
Raffaele Palladino - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Jeremy Chataway - Collaborator - University College London ( UCL )
Mark Cunningham - Collaborator - Imperial College London
Mekha Mathew - Collaborator - Imperial College London
Ruth Ann Marrie - Collaborator - University of ManitobaOutcomes:
- MS cases;
- Acute coronary events (acute myocardial infarction, coronary artery disease, coronary revascularisation procedures);
- Cerebrovascular disease (haemorrhagic and ischaemic stroke);
- Frailty level in PwMS (using the electronic Frailty Index score - eFI);
- All-cause and cardiovascular disease mortalityDescription: Lay Summary
Multiple sclerosis (MS) is a disabling disease of the central nervous system affecting more than 120,000 people in the UK. As compared with the general population, individuals with MS have a high level of disability and an increased risk of cardiovascular disease (a general term referring to conditions affecting the heart and blood vessels), because they are more likely to have elevated blood pressure and blood lipids, and to be obese, which are all risk factors for cardiovascular disease. Evaluating the cardiovascular risk of individuals with MS is therefore important, considering that increased cardiovascular risk in individuals with MS is also associated with more rapid disease progression and increased risk of death.
This project aims to improve our understanding of the association between cardiovascular risk factors, occurrence of major cardiovascular events (stroke and heart attack), and risk of disability in MS. Specifically, the project aims to evaluate whether the risk of major cardiovascular events in individuals with MS differs from the general population. The project also has an additional objective that consists in developing and validating a clinical tool to predict the risk of MS-related disability and major cardiovascular events for individuals with MS, suitable to be used by general practitioners and nurses when examining individuals with MS
Technical SummaryCardiovascular risk assessment and management is important in people with multiple sclerosis (PwMS) considering they have a high prevalence of cardiovascular risk factors, have increased risk of macrovascular complications, and cardiovascular risk factors are associated with more rapid disease progression and higher mortality.
This project aims to conduct a population-based retrospective cohort study of individuals with MS matched to controls by age, sex, and general practice to i) calculate trends of prevalence and incidence of MS in England; ii) assess the risk of macrovascular disease and mortality in MS; iii) assess whether in PwMS different levels of cardiovascular risk factors, presence of physical and mental-health co-morbidities, and pharmacological treatments for vascular risk are associated with differences in the risk of macrovascular disease, MS-related disability, and mortality; iv) assess whether PwMS are more frail than matched controls considering; v) test the performance and recalibrate of widely adopted vascular risk algorithms in PwMS as compared to people without MS; vi) develop and internally validate a risk prediction algorithm suitable for use in primary care settings to predict the risk of MS-related disability and macrovascular disease to ultimately tailor intervention strategies, while accounting for Frailty and other comorbidities and potential confounders including therapies for comorbidities.
Multivariable survival hazard models will be employed to assess whether incident rates of macrovascular events differ between individuals with MS and the control population. Specifically, for individuals with MS, a risk prediction algorithm will be developed for each of the following outcomes: occurrence of acute coronary events, occurrence of cerebrovascular events, and vascular mortality. Internal validation of the risk prediction algorithm will be performed using the k-fold method. Findings of this project will aid clinicians in accurately assessing the risk of major vascular events in PwMS, thereby supporting informed decisions regarding management of vascular comorbidity.
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Associations of SGLT2 inhibitors and GLP1 receptor agonists with incident dementia: a population-based cohort study — Walter Swardfager ...
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Associations of SGLT2 inhibitors and GLP1 receptor agonists with incident dementia: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-10
Organisations:
Walter Swardfager - Chief Investigator - Sunnybrook Research Institute
Walter Swardfager - Corresponding Applicant - Sunnybrook Research Institute
Baiju Shah - Collaborator - University of Toronto
Che-Yuan Wu - Collaborator - Sunnybrook Research Institute
Colleen Maxwell - Collaborator - University Of Waterloo
Jodi Edwards - Collaborator - University Of Ottawa
Moira Kapral - Collaborator - University of Toronto
Wajd Alkabbani - Collaborator - University Of WaterlooOutcomes:
All-cause dementia; Alzheimerâs disease dementia; vascular dementia.
All-cause dementia outcome in the primary analysis will be defined using primary care records based on the date of Read code (CPRD GOLD) or the date of SNOMED-CT classification code (CPRD Aurum) for all-cause dementia diagnosis. Alzheimerâs disease dementia and vascular dementia will be defined using a previously proposed algorithm (PMID: 23455986) based on Read code (CPRD GOLD) or SNOMED-CT classification code (CPRD Aurum) in primary care records. The algorithm for vascular dementia involves the identification of stroke events, and therefore HES admitted care data will be used to identify stroke cases that not captured in primary care records.
Description: Lay Summary
Type 2 diabetes is a medical condition that involves an inability to process sugar from the diet properly. Living with type 2 diabetes increases the chance that a person will develop dementia, a condition that can develop later in life that takes away a personâs abilities to think and to go about their daily lives on their own. It has been proposed that newer treatments for type 2 diabetes, including sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RAs), may offer new potential to slow the development of dementia. Although some studies have suggested that these types of drugs may have benefits to the brain, there remains too little evidence to conclude whether they might slow down dementia in people living with type 2 diabetes. Using information from family doctor visits and health records in the UK, we propose to determine whether people who have used these drugs remained free of dementia later into their lives. In our study, we will compare people who used these newer types of diabetes drugs to people who used a common older type of diabetes drug, a dipeptidyl peptidase-4 (DPP4) inhibitor, which is unlikely to slow down or speed up dementia progression if used. The study aims to suggest which types of drugs for diabetes might offer the largest brain benefits, and whether these types of drugs might be good choices for further testing in clinical trials to protect the brain as people age.
Technical SummaryType 2 diabetes increases the risk of dementia, but there is little evidence on how to reduce this risk. Using an active-comparator new-user cohort design, the primary aim of this study is to compare time to incident dementia diagnosis 1) between SGLT2 inhibitors and DPP4 inhibitors and 2) between GLP1-RAs and DPP4 inhibitors. The secondary aim is to compare time to dementia between GLP1-RAs and SGLT2 inhibitors, as the comparative effectiveness of these classes is of interest. The study will use an active-comparator new-user cohort design, and three separate cohort analyses of individuals older than 60 will be conducted. New users are defined as individuals without a prescription of either the treatment of interest of the comparator in the past year, and the exposure definition will follow an intention-to-treat approach. Incident all-cause dementia as the primary outcome and incident Alzheimerâs disease as an exploratory outcome will be determined based on the primary care records. Incident vascular dementia as the other exploratory outcome will be ascertained using both the primary care records and hospital admission records. Confounding by indication will be addressed using propensity scores. The confounders include demographics, practice-level index of multiple deprivation, laboratory measures, comorbidities, and medications. A 1-year lag period will be used to address disease latency and reverse causality. The adjusted hazard ratios and confidence intervals for time to dementia will be analyzed using a Cox proportional hazard model.
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Obstructive sleep apnoea syndrome and future risk of dementia — Shamil Haroon ...
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Obstructive sleep apnoea syndrome and future risk of dementia
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-07-06
Organisations:
Shamil Haroon - Chief Investigator - University of Birmingham
Jingya Wang - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Neil Cockburn - Collaborator - University of BirminghamOutcomes:
The primary outcome is all-cause dementia. The secondary outcomes are the two main subtypes of dementia, Alzheimerâs disease and vascular dementia.
Description: Lay Summary
Dementia, a syndrome that leads to deterioration in cognitive function mainly in older people, is currently the seventh leading cause of death and affects more than 55 million people globally. Since only about one-fifth of the disability-adjusted life years associated with dementia can be attributed to known modifiable risk factors, further work is needed to find and mitigate other modifiable risk factors causally associated with the future risk of dementia. Obstructive sleep apnoea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnoea events. It has been recognised as an independent risk factor for a number of chronic conditions. Emerging evidence suggests that OSAS may be associated with an increased risk of dementia, a general term for the impaired ability to remember, think, or make decisions that interferes with doing everyday activities. However, studies looking specifically at links between OSAS and the incidence of dementia are scarce, have poor study designs, and with small sample sizes. There is a need for large-scale population-based studies to investigate associations between OSAS and the risk of dementia and whether effective management of OSAS mitigates this risk. We hypothesise that OSAS is an independent risk factor the for future development of dementia. The objective of this study is to investigate the association between OSAS and the incidence of dementia.
Technical SummaryAims:
To investigate whether the presence of obstructive sleep apnoea syndrome (OSAS) is associated with an increased or decreased risk of subsequent development of dementia.Methods:
Using routinely collected primary care-based data across the UK (2000 - 2022), adults with OSAS will be compared with matched individuals without OSAS for the risk of developing dementia in later life. Competing risk Cox proportional hazard regression models will be used to calculate crude hazard ratios (crude HRs) and adjusted hazard ratios (adjusted HRs), together with their corresponding 95% CIs. Death during the follow-up period will be treated as a competing event.Outcomes:
The primary outcome is all-cause dementia. The secondary outcomes are the two main subtypes of dementia, Alzheimerâs disease and vascular dementia.Exposures:
The presence of OSAS.Participants:
Adults aged 18 years and above with no prior diagnosis of dementia at baseline and registered between 1st of January 2000 and to 31st of December 2022. Individuals with Parkinsonâs disease at baseline will be excluded. All participants must have been registered with the general practice for at least one year before the index date (start of follow-up).Covariates:
Sociodemographic characteristics, behavioural risk factors, comorbidities, biomarkers, and medications will be adjusted to account for residual confounding.
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ID-359: Extension: Care coordination for Adolescents in Crisis — Imperial College London...
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ID-359: Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Children and Young People.
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ID-361: Extension: Grenfell Population Health Monitoring — Westminster City Council...
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ID-361: Extension: Grenfell Population Health Monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Grenfell Health Monitoring.
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ID-366: Is there a case for an integrated care approach to detect and manage hypertension? A retrospective cohort study to better understands factors associated with poor controlled blood pressure and risks of developing hypertension using a regression modelling and AI algorithm across primary and social care settings – conditionally approved subject to changing proposed start date — Harrow Council...
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ID-366: Is there a case for an integrated care approach to detect and manage hypertension? A retrospective cohort study to better understands factors associated with poor controlled blood pressure and risks of developing hypertension using a regression modelling and AI algorithm across primary and social care settings – conditionally approved subject to changing proposed start date
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Harrow Council
Description: Hypertension.
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ID-360: Extension: Autism in WCC and RBKC — Westminster City Council...
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ID-360: Extension: Autism in WCC and RBKC
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Autism.
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ID-365: Networked Data Lab: Topic 4 – Exploring the role of Intermediate Care pathways in patient discharge, readmission rates and primary, secondary and social care usage across NWL. — Imperial College Health Partners...
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ID-365: Networked Data Lab: Topic 4 – Exploring the role of Intermediate Care pathways in patient discharge, readmission rates and primary, secondary and social care usage across NWL.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Intermediate Care. Commercial
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ID-363: Case mix severity – conditionally approved subject to changing project title and amending 4.2 — Imperial College London...
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ID-363: Case mix severity – conditionally approved subject to changing project title and amending 4.2
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Delivery of Care, Mental Health, Elderly People.
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ID-362: Extension: Study to evaluate the healthcare needs of unpaid carers and looked after children — Imperial College Health Partners...
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ID-362: Extension: Study to evaluate the healthcare needs of unpaid carers and looked after children
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Children and Young People. Commercial
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ID-364: Improving Access to Same-Day Non-Complex Primary Care in North West London — KPMG...
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ID-364: Improving Access to Same-Day Non-Complex Primary Care in North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-23
Opt Outs: no information provided./p>
Organisations: KPMG
Description: Primary Care. Commercial
Source
2023 - 06
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Department for Education: Data Access and Engagement Programme — unknown...
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Department for Education: Data Access and Engagement Programme
Where: unstated
When: 2023-6-28
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This ADR England project is funding the Department for Education (DfE) to make it easier and faster for accredited researchers to gain access to the data they need. The DfE will share more data through the ONS Secure Research Service using the legal gateway provided by the Digital Economy Act. The programme will also enable the DfE to engage with research bodies and academia around data opportunities and policy needs seeking to maximise the value of linked education data.
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DynAIRx (Dynamic Artificial Intelligence for Prescriptions): AIs (Artificial Intelligence) for dynamic prescribing optimisation and care integration in multimorbidity — Andrew Clegg ...
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DynAIRx (Dynamic Artificial Intelligence for Prescriptions): AIs (Artificial Intelligence) for dynamic prescribing optimisation and care integration in multimorbidity
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CCG Pseudonyms
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-14
Organisations:
Andrew Clegg - Chief Investigator - University of Leeds
Samuel Relton - Corresponding Applicant - University of Leeds
Asra Aslam - Collaborator - University of Leeds
Danushka Bollegala - Collaborator - University of Liverpool
Gary Leeming - Collaborator - University of Liverpool
Harriet Cant - Collaborator - University of Manchester
Iain Buchan - Collaborator - University of Liverpool
Lauren Walker - Collaborator - University of Liverpool
Layik Hama - Collaborator - University of Leeds
Matthew Sperrin - Collaborator - University of Leeds
Maurice O'Connell - Collaborator - University of Leeds
Micheal Abaho - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of Liverpool
Roy Ruddle - Collaborator - University of Leeds
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Primary Outcomes
all-cause emergency hospital admission; all-cause mortality
Secondary Outcomes
Hospitalization with an admission code for adverse drug reaction; Hospitalization with a fall or fracture; Hospitalization with delirium; GP diagnosis of dementia
Description: Lay Summary
This project aims to develop new, easy to use, artificial intelligence (AI) augmented tools that support GPs and pharmacists to find patients with multimorbidity (2+ long-term health conditions) who might be offered a better combination of medicines. We focus on people at risk of rapidly worsening health from multimorbidity and who are taking multiple regular medicines (polypharmacy) who might experience:
1. Hospitalisation (overall and because of medication side effects and adverse drug reactions).
2. Hospitalisation with a fall, fracture, or delirium.
3. Death.The National Health Service (NHS) introduced Structured Medication Reviews (SMRs) by GPs and pharmacists aiming to reduce the number of people taking potentially harmful drug combinations. However, there is no easy way of predicting who is most likely to benefit from a medication review. The Dynamic Artificial Intelligence for Prescriptions (DynAIRx) project will develop tools to combine information from electronic healthcare records, clinical guidelines and risk-prediction models to ensure that clinicians and patients have the necessary information to prioritise and support SMRs.
The main aim of the study is to find harmful interactions between conditions and medications and investigate potential improvements. We will develop AI augmented tools that combine GP and hospital records to calculate risks of hospital admissions and other adverse outcomes. To ensure this information is easily understandable, we will develop visual summaries of patientsâ journeys, showing how health conditions, treatments and risks are changing over time. This will be tested in general practices across northern England and improved based on feedback from stakeholders.
Technical SummaryPatients with multimorbidity and polypharmacy should have their medications reviewed regularly. However, these reviews do not always happen, and are conducted suboptimally because it is challenging to assemble the relevant information to make the best (de)prescribing decisions. DynAIRx will address this by predicting where patients would benefit from a medication review, and to support the conduct of that review with supporting models and visualisations. Public health benefit will arise via 1) better targeting of medication reviews to those most likely to benefit, and 2) improving the efficiency of planning/executing a medication review.
We will use CPRD Aurum data to identify adult patients with polypharmacy (>= 5 medications) in a longitudinal retrospective cohort design so that patients have polypharmacy at some point during the study period. Adverse outcomes of interest, emergency hospitalisation and death, will be derived from Aurum, and hospital episode statistics.
We will determine the extent of multimorbidity and polypharmacy using descriptive statistics (e.g. electronic frailty score, number of prescriptions within 84 days), and build statistical prediction models (logistic regression and Cox), augmented with AI techniques for predictor discovery and hypothesis generation, to predict adverse outcomes.
We will use causal analysis to identify which individuals stand to benefit most from a structured medication review, and calculate specific benefits of deprescribing interventions. The causal modelling will use propensity score matching for single-time interventions, and marginal structural models for longitudinal interventions (changing a given medication) â comparing observed effects to clinical trials for robustness, where available.
We will design visualisations of the relevant data, augmented with information from our models, to support GPs in delivering better informed and more efficient structured medication reviews. The decision to modify treatments during medication review will remain with clinicians and patients. We anticipate further CPRD applications to arise for future research, building upon these findings.
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Development, external validation and health economic evaluation of primary care diagnostic prediction models for upper gastro-intestinal cancers — Garth Funston ...
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Development, external validation and health economic evaluation of primary care diagnostic prediction models for upper gastro-intestinal cancers
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-27
Organisations:
Garth Funston - Chief Investigator - Queen Mary University of London
Garth Funston - Corresponding Applicant - Queen Mary University of London
Borislava Mihaylova - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Fiona Walter - Collaborator - Queen Mary University of London
Laura Woods - Collaborator - Newcastle University
Oleg Blyuss - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Rohini Mathur - Collaborator - Queen Mary University of London
Runguo Wu - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Tyler Saunders - Collaborator - Queen Mary University of LondonOutcomes:
The primary clinical outcome is a diagnosis of an UGI cancer, as recorded in NCRAS data, within the 24 months following study entry (defined below). Model performance for alternative follow-up periods and for early stage cancer (stage I-II) will be explored in sensitivity analyses.
Further outcomes of interest to inform the health economic analysis will include cancer diagnostic tests; cancer stage at diagnosis; cancer treatments received; cancer recurrences; and cause-specific mortality.Description: Lay Summary
Most patients with upper gastro-intestinal cancers have symptoms and visit their family doctor multiple times before being diagnosed. This suggests that their cancer could be picked up earlier, which would open more opportunities for treatment to help them live longer. However, many of the symptoms of upper gastro-intestinal cancer are common in patients who donât have cancer, so it can be difficult to decide which patients should be referred to the hospital for urgent tests.
The aim of this study is to develop an accurate and cost-effective tool to help GPs spot patients at increased risk of having upper gastro-intestinal cancer earlier. We will use anonymised primary care and linked cancer registry, hospital, imaging and deaths information. We will develop statistical models which will tell us how likely cancer is in each patient. The models will include information on symptoms, tests and prescriptions. Taken together, this information could indicate whether cancer is likely to be present. In addition to traditional statistical methods, we will use newer âmachine learningâ (artificial intelligence) to develop statistical models. This will allow us to take account of changes in information over time which may be important. We will test how well the models work and explore whether they would be useful to doctors. Finally, we will explore the impact of using the models on health outcomes (e.g. how many patients are cured) and healthcare resources. This research has the potential for public benefit as the models could aid early detection of upper gastro-intestinal cancer.
Technical SummaryOutcomes for the commonest upper gastro-intestinal (UGI: oesophago-gastric, pancreatic, gallbladder and biliary tract) cancers remain poor. Most UGI cancer patients have symptoms and multiple GP consultations in the two years pre-diagnosis, suggesting earlier detection is possible, with opportunities to treat with curative intent and improve outcomes. However, many of the symptoms of UGI cancer are common in primary care and it can be difficult to determine which patients should be referred for urgent investigation.
Available diagnostic prediction models do not account for temporal changes in predictors and only provide risk estimates for individual UGI cancers. In this study, we will utilise primary care (CPRD) and linked cancer registry (NCRAS, SACT), hospital (HES), imaging (DID), deprivation (IMD) and mortality (ONS) data to develop and validate a diagnostic prediction model for UGI cancer. A linked CPRD Aurum dataset will be used to develop models using both traditional methods and machine learning approaches, which will allow us to take account of dynamic changes in predictors. Variable selection will be informed by a systematic literature review. We will empirically compare the performance of conventional vs machine learning techniques (including deep neural networks, support vector machines and random forests) to identify the best performing approach. Models will be externally validated using CPRD GOLD. We will assess model calibration and discrimination and compare model performance at a range of risk thresholds, including the NICE 3% risk threshold for urgent cancer referral. We will perform health economic analyses to compare model âaction thresholdsâ and determine how the models might be used to best effect within the diagnostic pathway. This project fits within a larger package of work which aims to develop an UGI multi-cancer early detection (MCED) Platform (CanDetect). The research has the potential for public benefit as the models could aid early detection of UGI cancer.
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Prognosis and healthcare costs of musculoskeletal pain in children and adolescents in primary care — Kelvin Jordan ...
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Prognosis and healthcare costs of musculoskeletal pain in children and adolescents in primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-29
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kayleigh Mason - Corresponding Applicant - Keele University
Anna Jöud - Collaborator - Lund University
Faraz Mughal - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Joanne Protheroe - Collaborator - Keele University
Kate Dunn - Collaborator - Keele University
Kym Snell - Collaborator - University of Birmingham
Martin Thomas - Collaborator - Keele University
Sue Jowett - Collaborator - University of Birmingham
Zainab Abdali - Collaborator - University of BirminghamOutcomes:
i. Number of musculoskeletal pain consultations;
ii. Further new consulting episodes of musculoskeletal pain in the same body-site;
iii. New consulting episodes of musculoskeletal pain in different body-sites;
iv. Onward referral for musculoskeletal pain;
v. Musculoskeletal consultation trajectory over time based on annual patterns of consultation after index consultation;
vi. Mean costs in primary care in the first year after index consultation. Primary care data will include number, type and length of consultations (standard or double appointment) with each health care professional, prescriptions, tests, investigations and referrals.
vii. Overall mean annual cost and the mean cost over a longer period of time (e.g. 5 years; period to be determined once the median follow-up period is established).Description: Lay Summary
Pain in places such as the feet, knees or back (called musculoskeletal pain) is common in children. Musculoskeletal pain is a leading cause of disability across the world. Despite this, there is little research about childhood musculoskeletal pain and which children are more at risk of continuing to have pain.
The aim of this study is to find out more about what happens to the children or adolescents who visit their doctor for musculoskeletal pain, including whether they have further visits to the doctor for the same pain or for different pain over the next few years and what may help doctors identify individuals who are more likely to get better or not.
We will use data for children aged between 8 and 18 years who see their doctor for a new musculoskeletal pain between 2005 and 2021 to work out:
⢠how many children visit their doctor again for musculoskeletal pain over the next few years,
⢠whether we can find out what factors (for example, their age, sex, other illnesses they have) increase the likelihood they will see their doctor more often for musculoskeletal pain,
⢠the cost of health care including visits to the doctor and medicines given to children with musculoskeletal pain.The results of this study will feed into a larger research study, which aims to develop information and self-management resources for children (and their parents and carers) about musculoskeletal pain.
Technical SummaryMusculoskeletal pain is a leading cause of disability in children and adolescents and increases the risk of pain in adulthood. The aim is to determine overall prognosis, factors which may predict persistent or recurrent health care use for musculoskeletal pain, and health service costs of children/adolescents presenting with new musculoskeletal pain.
The study population comprises children/adolescents (aged 8-18 years) seeking primary care for non-specific musculoskeletal pain. We will exclude children with recorded trauma or cancer. Patients will be followed from index musculoskeletal consultation. We will use CPRD Aurum to i) determine the number and patterns of musculoskeletal pain consultations and referrals, ii) identify prognostic factors for persistent and recurrent consultation, and iii) estimate mean cost of healthcare resource utilisation. Potential prognostic factors will include socio-demographic, lifestyle, and musculoskeletal-related (e.g. body site, analgesia) factors as well as comorbidities, non-musculoskeletal pain and other symptoms. Index of Multiple Deprivation data will be utilised as deprivation may be a key prognostic factor given inequalities in musculoskeletal pain by deprivation. This will allow outcomes from this study to be applicable across children/adolescents living in areas of deprivation.
We will summarise median (IQR) number and annual rate of musculoskeletal pain consultations, rate of new musculoskeletal pain consulting episodes, and referrals. Common patterns of annual consultation for musculoskeletal pain over follow-up will be derived through latent class growth analysis. Flexible parametric survival models will be used to determine prognostic factors for a new consulting episode of musculoskeletal pain and Poisson or negative binomial regression (as appropriate) for number of future consultations.
This study is part of a NIHR-funded research programme, and findings will lay the basis for guidelines for treating musculoskeletal pain in children/adolescents, with the programme aiming to develop resources to improve self-management of musculoskeletal pain in children/adolescents and lessen its long-term impact.
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Quantifying the risks of deprescribing of long-term cardiovascular medicines in people with limited life expectancy — Rupert Payne ...
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Quantifying the risks of deprescribing of long-term cardiovascular medicines in people with limited life expectancy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-27
Organisations:
Rupert Payne - Chief Investigator - University of Exeter
Rupert Payne - Corresponding Applicant - University of Exeter
Gary Abel - Collaborator - University of Exeter
Jo Butterworth - Collaborator - University of Exeter
Nurunnahar Akter - Collaborator - University of ExeterOutcomes:
Major adverse cardiovascular events; Adverse drug events; Mortality
Description: Lay Summary
Many medicines have long-term benefits and prevent illness. These preventative medicines are often stopped in the last few weeks of a personâs life, when it is clear they will die soon and not benefit from the medicines. However, the benefit of continuing to take preventative medicines over a longer period â the last year or two of life â may also be small, so it may be reasonable for patients to stop preventative medicines sooner.
However, we do not know which people with limited life expectancy should consider stopping preventative medicines. And we do not know what the consequences of stopping preventative medicines might be for patients.
This study will use existing scientific research about the benefits and risks of different preventative medicines. It will combine this with an existing method for estimating how long a person might live. We will use routine prescribing information from CPRD and apply statistical methods to work out what the effect of stopping these medicines might be for people with limited life expectancy.
Our research will provide us with important information that will help health professionals and patients make informed decisions about stopping preventative medicines with limited benefit.
Technical SummaryMany medicines have long-term benefits, but patients with limited life expectancy may not live long enough to benefit fully. In such situations deprescribing may be appropriate. This happens in palliative care settings, but evidence is lacking about how deprescribing should happen in broader practice, and whether it can be done safely. In particular, quantifiable information about risks involved may help inform patient-centred decision making.
This study aims to produce algorithms that quantify the potential loss of therapeutic benefit and reduction in drug-related harm from deprescribing long-term preventative medicines in patients with limited life expectancy.
A cohort study will be conducted in CPRD GOLD, with four elements:
1. The QMortality algorithm will be independently validated using linked ONS mortality data, using QMortality to estimate 1- and 2-year mortality, and predictive ability assessed using ROC, C-statistics, D-statistics, calibration curves and overall fit. HES APC data will be an input for QMortality.
2. Baseline cumulative hazard will be estimated along with QMortality coefficients to estimate survival functions.
3. Baseline risk of major adverse cardiovascular events [MACE] and adverse drug events [ADE] will be estimated using existing risk models alongside QMortality to estimate likelihood of outcomes in a patientâs remaining life. MACE/ADE will be determined from HES and GOLD. Combining estimates of relative treatment effect (safety/efficacy) from the literature for three key drugs (antihypertensives, statins, anticoagulants) will enable determination of individualised benefit/harm estimates for each treatments in the context of limited life expectancy.
4. A descriptive epidemiological analysis will provide understanding of the prevalence and distribution of life expectancy and medication benefits/harms.Resulting algorithms will underpin a clinical informatics toolkit to support personalised deprescribing in primary care. Findings will also provide insight into the scope for deprescribing and help identify the types of patients most likely to gain from deprescribing.
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Therapeutic inertia and its association with healthcare resource utilisation, complications, and costs in individuals with uncontrolled type 2 diabetes: a UK population-based retrospective analysis — Nick fabrin Nielsen ...
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Therapeutic inertia and its association with healthcare resource utilisation, complications, and costs in individuals with uncontrolled type 2 diabetes: a UK population-based retrospective analysis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-05
Organisations:
Nick fabrin Nielsen - Chief Investigator - Novo Nordisk A/S
Nick fabrin Nielsen - Corresponding Applicant - Novo Nordisk A/S
Ayush Srivastava - Collaborator - Novo Nordisk Service Centre India Pvt Ltd.
Elisabeth de Laguiche - Collaborator - Novo Nordisk A/S
Marisse Asong - Collaborator - Novo Nordisk A/SOutcomes:
The study primary outcome will be:
1) Among people living with uncontrolled T2DM despite use of glucose lowering therapies, to describe the proportion who do not receive treatment intensification within 12 months of being defined as having uncontrolled diabetes (Identification period), and their clinical and demographic characteristicsSecondary outcomes will be:
2) The proportion of people living with uncontrolled T2DM despite use of glucose lowering therapies, who receive treatment optimisation during the Identification period;
3) Describing the treatment intensification patterns by T2DM medication class in those that receive treatment intensification during the Identification period
4) Associations during the Outcome period (12-36 months post index) between those who receive treatment intensification vs those who do not during the Identification period for the following:
⢠Healthcare resource utilisation and direct healthcare costs
⢠Change in HbA1c levels
⢠Incident rates for cerebrovascular events, acute coronary syndrome, peripheral vascular disease, retinopathy, neuropathy, nephropathy, end stage renal disease, hypoglycaemic emergencies.
⢠All-cause mortalityDescription: Lay Summary
Diabetes (where the body cannot use or produce insulin properly) represents one of the most common diseases worldwide with more than 500 million people affected. Of those people living with diabetes, about 90% have type 2 diabetes. Individuals living with uncontrolled diabetes, defined as having consistently high blood sugar, are at higher risk of negative health outcomes, including stroke and heart attacks, than those with controlled diabetes. The National Institute for Health and Care Excellence (NICE) recommends that people with uncontrolled type 2 diabetes should be offered additional treatment, including intensification/optimisation of drug treatment. The goal being to control blood sugar levels and therefore reduce the risk of adverse events or death.
This study will use data from medical records to explore if people with uncontrolled type 2 diabetes in the UK are receiving additional treatment or other changes to their medications. Data will be assessed using electronic health records from the Clinical Practice Research Datalink, where participants will be included in the study based on their type 2 diabetes diagnosis and evidence of uncontrolled blood sugar. The aim of this study is to observe whether patients receive changes in their glucose lowering medication in the first 12 months of being diagnosed with uncontrolled type 2 diabetes. We will also investigate if changing treatment is associated with changes in blood sugar and complications. The findings from this project will provide insights into whether people with uncontrolled type 2 diabetes are receiving guideline-recommended treatment when they present with uncontrolled blood sugar.
Technical SummaryIt is NICE guidance for people with uncontrolled type 2 diabetes mellitus (T2DM) to receive intensification of glucose lowering therapies until glycaemic targets are reached. Despite the established benefits of early intervention, little is known about the proportion of people with uncontrolled T2DM in the UK who do receive this guideline-recommended treatment. This retrospective cohort study aims to describe the degree of therapeutic inertia through treatment patterns in people diagnosed with uncontrolled T2DM despite use of glucose lowering therapies, using electronic health records in CPRD from 2012. Uncontrolled T2DM will be defined as a HbA1c measurement of â¥7.5% and individuals will need to be treated with â¥2 oral antidiabetic medications and/or a GLP-1 in the preceding 12-months to enter the study population, with date of raised HbA1c used as the index date (cohort entry date). The primary outcome is quantifying and characterising any vs. no treatment intensification in the 12-months after index, with evidence of treatment optimisation being a secondary outcome. Individual-level categorisation (any treatment intensification vs. no treatment intensification) will be subsequently used as an exposure for analysing secondary outcomes.
T2DM medications will be handled at the class-level with descriptive analysis used to report the proportion of individuals not receiving treatment intensification in the 12-months post index (Identification period). Following the 1 year Identification period, the association between the âany treatment intensificationâ sub-group (study-group) and âno treatment intensificationâ sub-group (comparator) will be quantified for change in HbA1c, healthcare resource utilisation, direct healthcare costs, and incident disease complications rates during a 2-year Outcome period (years 2 & 3 post index). Our study will provide insights on the extent to which therapeutic inertia is present in people with uncontrolled T2DM. Better understanding of the implementation of treatment guidelines can inform strategies for further improving care for people living with diabetes.
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Prevalence and Incidence of Duchenne Muscular Dystrophy in England — Shuk...
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Prevalence and Incidence of Duchenne Muscular Dystrophy in England
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-05
Organisations:
Shuk-Li Collings - Chief Investigator - Pfizer Ltd - UK
Shuk-Li Collings - Corresponding Applicant - Pfizer Ltd - UK
Darren Jeng - Collaborator - Pfizer Inc - US Headquarters
Elena Rivero Sanz - Collaborator - Pfizer Ltd - UK
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UKOutcomes:
Prevalence rate; incidence rate
Description: Lay Summary
Duchenne Muscular Dystrophy (DMD) is a rare condition, present at birth. It is a genetic disorder that affects the muscles; they become weak and rapidly worsen over time leading to disability and the need for breathing support. DMD is mostly found in males, however there are a small number of females who carry the genetic mutation. It is a debilitating and devastating condition; the average life expectancy is between 19 and 32 years.
Technical Summary
There is no cure for DMD. Current treatments help to relieve some of the symptoms. However, there are several new therapies that are being developed. As part of understanding the impact of DMD and the need for new treatments, we must understand how many patients have DMD in England. There are no recent estimates of this in the public domain. We wish to use CPRD Aurum data to calculate the proportion of people of people in England who are living with DMD and the proportion of babies born with DMD.Duchenne muscular dystrophy (DMD) is a devastating progressive neuromuscular disease that significantly impacts patientsâ lives, as well as their parents and families. It is a severely debilitating condition, which shortens and impairs quality of life with currently limited treatment options.
The DMD-causing mutation is present at birth, and current evidence suggests that muscle damage begins at approximately 2 years of age. The typical onset of DMD symptoms is in early childhood, between the ages of 2 and 5 years, with symptoms on average appearing at 2.5 years old
There is no cure for DMD and treatment is mainly supportive. Due to progressive respiratory muscle weakness, ventilatory support is increasingly required, either through non-invasive or invasive (tracheostomy) ventilation. Despite optimal care, most patients with DMD die in young adulthood, typically between the ages of 25-30, with a median age of death of 29.9 years (when receiving ventilatory support). Death usually results from pneumonia, or cardiac and/or respiratory failure.
There are several innovative therapies in development for DMD. In order to demonstrate the unmet need for DMD, it is essential to obtain up-to-date estimates of the incidence and prevalence of DMD to allow us to estimate the number of patients who could potentially benefit from new therapies. Existing prevalence estimates are out-dated or not representative of England. We propose using CPRD Aurum to calculate the incidence and prevalence of DMD.
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Treatment pathway for patients with open angle glaucoma: a descriptive study — Jonathan Belsey ...
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Treatment pathway for patients with open angle glaucoma: a descriptive study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-27
Organisations:
Jonathan Belsey - Chief Investigator - JB Medical Ltd
David Sgorbati - Corresponding Applicant - The Health Economics Unit
Jonathan Belsey - Collaborator - JB Medical Ltd
SANTOSH KUMAR - Collaborator - NHS MIDLANDS AND LANCASHIRE COMMISSIONING SUPPORT UNIT
XIAOXU Zou - Collaborator - The Health Economics UnitOutcomes:
Task 1
Total number of people in CPRD and number with qualifying glaucoma code, divided in female/male and 40-54/55-69/70-84/85+ age brackets.Task 2
Time elapsed between blindness, incisional surgery, MIGS, SLT and topical therapy.Task 3
Number of people qualifying glaucoma code, divided in female/male and 40-54/55-69/70-84/85+ age brackets, and with a count of how many comorbidities they have for each of the 10 identified categories.Description: Lay Summary
Understanding the treatments currently administered for glaucoma, an eye condition where the nerve connecing the eye to the brain is damaged, is challenging because the relevant information being is spread across GP and hospital datasets. Many treatments are available, including eye drops, oral medicines, and surgery, but it's currently unclear for how long a patient is likely to be administered a treatment between being moved to a different one. Lastly, it is recognised some additional conditions, such as severe mental illness or post-stroke partial paralysis, could affect adherence to treatment, in particular for eye drops, but there are no sources in the literature documenting the severity of the issue.
Technical Summary
The study aims to describe the steps currently taken in the UK to manage glaucoma, documenting how the condition tends to progress, noting the amount of time patients are spending being treated with each approach, and highlighting of possible drivers for treatment change.
This will benefit the UK population, especially the cohort with glaucoma in addition to other conditions which affect their ability to follow treatment treatment, as it it will expose areas where greater support is required.Glaucoma management relies on controlling intra-ocular pressure (IOP) to prevent irreversible retinal damage. No treatments can modify the disease process, but IOP control options can delay visual impairment.
Objective of Task 1: to count all patients with glaucoma. While procedures will be reliably documented in secondary care, they may not capture all patients, particularly those in the early stages of the disease.
Objective of Task 2: to describe the treatment progression associated with glaucoma. To capture longitudinally the full treatment sequence from diagnosis to end-stage, a patient cohort needs to be followed up for 10-15 years. Thus, a fractionated retrospective approach is proposed, which involves identifying patients in five cohorts based on codes for blindness, incisional surgery, MIGS, SLT, and topical therapy in the past 5 years. Five separate time to event Kaplan-Meier survival curves will be constructed for each cohort.
Objective of Task 3: to count the number of patients with the 40 comorbidities identified by the literature and by a board of ophthalmologists to potentially affect adherence to topical therapy. To protect confidentiality and ensure the analysis is manageable, we mapped them into 10 categories: low vision; movement disorders, including congenital and degenerative CNS disorders; post stroke impairment and other paralyses; peripheral neuropathies and myopathies, including SLE; arthropathies and injuries affecting upper limbs; degenerative, traumatic and pathological CNS disorders disrupting cognitive function; severe mental illness; substance dependence; intellectual disability; and CNS and mental conditions NOS.
The population of interest for this retrospective cohort study includes all UK glaucoma patients in 2017-2022.
We will use HES Admitted Patient Care and Outpatient, as glaucoma is primarily managed in secondary care, but we will supplement this with CPRD Aurum, as HES data are often incomplete, while GP records will likely include diagnoses originating from hospital appointments and topical therapy prescription information.
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Real-world insights into the early treatment effects of dapagliflozin among patients with chronic kidney disease in UK clinical setting: an observational study — Jil Billy Mamza ...
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Real-world insights into the early treatment effects of dapagliflozin among patients with chronic kidney disease in UK clinical setting: an observational study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-13
Organisations:
Jil Billy Mamza - Chief Investigator - AstraZeneca Ltd - UK Headquarters
He Gao - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Alexander Gueret-Wardle - Collaborator - AstraZeneca Ltd - UK Headquarters
Benjamin Heywood - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Leah Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK HeadquartersOutcomes:
⢠Baseline demographic and clinical characteristics
⢠Time to dapagliflozin treatment initiation and factors associated with treatment initiation
⢠Changes in the estimated glomerular filtration rate (eGFR) and albumin-creatinine ratio (ACR) measurements over time
⢠Descriptions of medication issues and treatment change patterns over time
⢠Time to clinical outcomes including cardiovascular, kidney and mortality outcomes
⢠Outcomes stratified by baseline demographic, disease, laboratory tests measurements, treatment-related factors as well as subgroup populations.Description: Lay Summary
Kidney disease is an important and serious problem that is commonly associated with diabetes and hypertension. The relationship between kidney and cardiovascular diseases are increasingly being recognised as leading cause of severe illness and these diseases should be detected and treated in early stages in order to prevent complications and deaths. In a time of emerging treatment options that may offer benefits to patients with kidney disease, there is an increasing need to understand the characteristics of patients affected, those who might be eligible to receive these treatments and the impact of the choice of medications used to treat these patients in clinical practice. The results from recently concluded clinical trials are very encouraging and show new treatments reduced the progression of heart failure as well as kidney deterioration in patients with and without diabetes. However, as only limited number of people can be enrolled in trials due to the rigorous selection criteria, the findings may not be generalised across all populations. In addition there is very sparse information on the characteristics of specific subgroup populations, particularly people who may be at a higher risk of experiencing chronic kidney disease. Therefore, this study will use administrative healthcare records to describe populations of patients with chronic kidney disease in order to understand the demographic and clinical characteristics, treatment patterns, drug utilisation and the change in kidney disease progression before and after initiation of the new treatments.
Technical SummaryUsing a cohort of patients with a diagnosis for chronic kidney disease (CKD), we aim to describe and compare the characteristics of patients who initiated treatment with dapagliflozin, a sodium-glucose co-transporter-2 (SGLT-2) inhibitor over time. This include the epidemiology of dapagliflozin and other SGLT-2 inhibitor treatment uptake in various population groups, description of the treatment patterns and the impact of the choice of medications used to treat these patients on clinical outcomes. This study will utilise the CPRD Aurum database and the study period will begin on 1 January 2015 until the last GPâs collection day. Each of the outcome measures of interest will be described separately. Patient characteristics and health care resource use will be described for the study population and the results will be summarised using descriptive statistics. Event rates and 95% confidence intervals will be reported as incidence rates. Survival distributions utilising Kaplan-Meir method will describe time to treatment initiation or treatment substitution from the date of licence approval or latest consultation after the licence approval date for dapagliflozin use for CKD. Relative risks and risk factors associated with clinical outcomes will be estimated using Cox proportional hazard regression. In addition, we aim to further evaluate the treatment pathways of the patients to describe their health resource use including GP consultations, laboratory tests, medication, referrals to specialist and hospital admissions. Such evidence will be used to highlight any unmet treatment needs and inform the evidence gap in this area.
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The association between comorbid mental health conditions and risk of exacerbations and mortality among patients with chronic obstructive pulmonary disease — Nicola Adderley ...
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The association between comorbid mental health conditions and risk of exacerbations and mortality among patients with chronic obstructive pulmonary disease
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-16
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Nicola Adderley - Corresponding Applicant - University of Birmingham
Amanda Farley - Collaborator - University of Birmingham
Yiping Wu - Collaborator - University of BirminghamOutcomes:
There are two outcomes, 1. exacerbations of COPD and 2. all-cause mortality. COPD exacerbation will be defined as a record of a prescription for antibiotics or oral corticosteroids or both in COPD patients during the follow-up period. All-cause mortality will be obtained from primary care records.
Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a common disease of the lungs. People with COPD experience breathlessness, coughing and sputum (phlegm), as well as periods of worsening of symptoms (exacerbations) where they may need additional treatment or be hospitalised. Many people with COPD have a mental health diagnosis, such as anxiety, depression, or severe mental illness.
Some studies have shown that people with COPD who also have a mental health diagnosis may have a higher risk of COPD exacerbations and have a higher death rate compared with people with COPD and no mental health condition. However, many of these studies are small and no studies have looked at this relationship in a large dataset from the UK.
Therefore, the objectives of this study are:
1. We will describe and compare the characteristics of COPD patients with and without a mental health diagnosis.
2. In people with COPD, we will investigate the relationship between having any mental health diagnosis and the risk of COPD exacerbation and the risk of death.
3. To explore the impact of different mental health conditions (depression, anxiety, severe mental illness) on the risk of COPD exacerbation and the risk of death, we will conduct three separate analyses in groups of people with these specific mental health diagnoses.If we find a link between mental health conditions in COPD and exacerbations or death, this will provide useful information for patients and healthcare practitioners, and perhaps support doctors to manage COPD patients with mental health conditions more effectively.
Technical SummaryAims and objectives: Among people with COPD, to estimate 1. the association between a diagnosis of any mental health condition and COPD exacerbations; 2. the association between a diagnosis of any mental health condition and all-cause mortality; and 3. the associations between specific mental health conditions (depression, anxiety, severe mental illness) and exacerbations and mortality.
The study population will be adults diagnosed with COPD. The exposed group will be those with a diagnosis of a mental health condition (depression, anxiety, or severe mental illness) prior to their COPD diagnosis. The unexposed group will be those with no record of a mental health condition (before or after the COPD diagnosis). Primary outcome is COPD exacerbations, defined as a prescription for antibiotic or oral corticosteroid; secondary outcome is all-cause mortality. The data source will be Primary care records extracted from CPRD GOLD.
We will conduct a retrospective, matched cohort study in patients diagnosed with COPD. To explore the association between mental health conditions and COPD exacerbations (count data), we will calculate crude incident rates and adjusted incident rate ratios using Poisson regression, adjusting for key confounders. To investigate the association with all-cause mortality, we will calculate crude hazard ratios (HRs) and adjusted hazard ratios (aHRs) using Cox proportional hazards models, adjusting for key confounders. We will assess the proportional hazards assumption using log-log plots and the Schoenfeld residuals test. All analyses will be conducted in Stata.
If an association between mental health conditions in COPD and patient outcomes is found, this will provide useful information for patients and clinicians, and potentially support improved management of patients with comorbid mental health conditions.
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Longitudinal Assessment of Ethnicity Completeness and Distributions in CPRD Aurum — James Carpenter ...
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Longitudinal Assessment of Ethnicity Completeness and Distributions in CPRD Aurum
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-05
Organisations:
James Carpenter - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Esther Tolani - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Irene Petersen - Collaborator - University College London ( UCL )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The primary outcome of this study is ethnicity recording, we plan to assess how the capture of this variable is affected by registration year and demographic factors: age group, sex, region, and IMD score.
Description: Lay Summary
Reports have shown that ethnicity plays a role in the health outcome of patients. As a result, ethnicity is an important factor in research studies. This study aims to describe the capture and distribution of ethnicity data in CPRD Aurum, a primary care database. All patientsâ ethnicities will be reported overall and by patient factors: sex, region, age group, index of multiple deprivation and registration year. This will provide a picture of the current ethnicity missingness patterns in the data source, showing how it is not recorded in connection to patient factors. The findings of this study will help develop guidance methods for handling missing ethnicity data in database studies. This will help researchers improve study results and provide further insights for understanding health inequalities related to ethnicity.
The common methods for handling missing ethnicity data include creating a combined missing or unknown category, excluding individuals with missing ethnicity or all together exclusion of ethnicity from the analysis. Multiple imputation is a popular statistical method for handling missing data in medical research. One of the limitations of this method for ethnicity in particular is that the data missingness is not at random. When this assumption is not true results created may be misleading. One way to compare ethnicity data captured in databases is to compare distributions to a âgold standardâ benchmark such as census data from the Office of National Statistics (ONS). As a final step in this study, we plan to compare observed ethnicity distributions to ONS data.
Technical SummaryEthnicity is an important factor in health outcomes research. Several methods have been developed to handle missing ethnicity data, including weighted imputation using population level estimates and multiple imputation by chained equations. However, there is currently no best practice guidance for managing missing ethnicity data in UK primary care research studies.
This study will comprise of two objectives:
1. To describe ethnicity completeness in UK primary care by the following demographic factors: sex, region, age group, index of multiple deprivation (IMD) score and registration year
2. To compare missingness levels across the demographic factors to Office of National Statistics (ONS) dataThe study period will be between 01 January 2000 until 31 December 2022, all previously registered patients and newly registered patients will be captured within this period. All patients in CPRD Aurum will be eligible for the study, not limiting to disease or pre-specified exposures. Ethnicity completeness will be described overall and stratified by year, newly registered patients, and ethnic groups. To compare between the different levels of completeness logistic regression analyses will be performed for the variables of interest. As a final step in this study, we plan to compare observed ethnicity distributions to ONS data stratifying by region. The findings of this study will help develop guidance and methods for handling missing ethnicity data in database studies. This will help researchers improve study results and provide further insights for understanding health inequalities related to ethnicity. Improved data methods and accuracy of study results from will aid the development of health intervention that improve patientâs health outcomes.
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Defining an evidence base for the use of Advice and Guidance Referrals (BADGER) — Claire Burton ...
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Defining an evidence base for the use of Advice and Guidance Referrals (BADGER)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-07
Organisations:
Claire Burton - Chief Investigator - Keele University
Kayleigh Mason - Corresponding Applicant - Keele University
James Bailey - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Victoria Welsh - Collaborator - Keele UniversityOutcomes:
Number of patients recorded with incident SLE diagnosis and:
(i) a routine referral recorded in previous 0-24 months and previous 25-36 months;
(ii) Advice and Guidance recorded in previous 0-24 months and previous 25-36 months; and
(iii) both an Advice and Guidance and routine referral code recorded in the previous 0-24 months and previous 25-36 months.We will also calculate the median time to diagnosis from a first request for Advice and Guidance or routine referral within 36 months prior to diagnosis.
Description: Lay Summary
When a GP needs a specialistâs input with the care of a patient, one option is to use âAdvice and Guidanceâ. Advice and Guidance is an electronic way for a GP to ask a clinical question and a specialist responds, usually within a few days. The response may be to send the patient to see a specialist (referral), try a treatment, or do a test. Advice and Guidance was introduced to speed up access to a specialist opinion and cut waiting times for outpatient care. There are few studies telling us whether Advice and Guidance has a better or worse effect on patient care versus usual referrals.
The aim of this feasibility study is to determine (i) how often Advice and Guidance is used by GPs prior to a condition being diagnosed, and (ii) summarise the time between Advice and Guidance and diagnosis records.
We will use a national database of anonymous GP records to find patients who have been newly diagnosed with systemic lupus erythematosus (SLE) between 01/01/2015 and 31/12/2022. We will determine how many patients have a request for Advice and Guidance and/or a routine referral in their notes in the 3 years prior to diagnosis. We will calculate the time to diagnosis of SLE from a first request for Advice and Guidance or routine referral.
Technical SummaryWhen a GP needs a specialistâs input with the care of a patient, one option is to use âAdvice and Guidanceâ. Advice and Guidance is an electronic way for a GP to ask a clinical question and a specialist responds, usually within a few days. The response may be to refer the patient to secondary care, initiate a new treatment, or do an investigation. Advice and Guidance was introduced to speed up access to a specialist opinion and cut waiting times for outpatient care. There are few studies telling us whether Advice and Guidance has a better or worse effect on patient care versus usual referrals.
The aim of this feasibility study is to determine (i) how often Advice and Guidance is used by GPs prior to a condition being diagnosed, and (ii) the time between Advice and Guidance and diagnosis records.
We will use the Clinical Practice Research Datalink (CPRD) Aurum database of de-identified electronic primary care records to determine the number of individuals newly diagnosed with systemic lupus erythematosus (SLE) between 01/01/2015 and 31/12/2022. We will determine the proportion of individuals with (i) Advice and Guidance only, (ii) routine referral only, (iii) both Advice and Guidance and routine referral, and (iv) neither Advice and Guidance and routine referral recorded in their notes in the 3 years prior to diagnosis. To determine the most appropriate prior registration period, we will stratify the proportion of patients recorded with Advice and Guidance and/or routine referral into those with records in the 0-24 months and 25-36 months prior to SLE diagnosis. We will also calculate the time to diagnosis of SLE from a first request for Advice and Guidance or routine referral.
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Characteristics and the economic burden of COVID-19 associated bacterial, viral and fungal infections in the general population in England — Kevin Naicker ...
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Characteristics and the economic burden of COVID-19 associated bacterial, viral and fungal infections in the general population in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-27
Organisations:
Kevin Naicker - Chief Investigator - Pfizer Ltd - UK
Theo Tritton - Corresponding Applicant - Adelphi Real World
Amitava Banerjee - Collaborator - University College London ( UCL )
Charles Reynard - Collaborator - Pfizer Ltd - UK
Christina Diomatari - Collaborator - Adelphi Real World
Christopher Little - Collaborator - Pfizer Ltd - UK
Gillian Kiely - Collaborator - Pfizer Ltd - UK
Jingyan Yang - Collaborator - Pfizer Inc - US Headquarters
Kamlesh Khunti - Collaborator - University of Leicester
Kiran Rai - Collaborator - Adelphi Real World
Lucy Massey - Collaborator - Adelphi Real World
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Olivia Massey - Collaborator - Adelphi Real World
Poppy Payne - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Tendai Mugwagwa - Collaborator - Pfizer Ltd - UKOutcomes:
BVF infections; healthcare resource use (primary care general practice consultations, hospitalisations, re-admissions (<30 days from discharge), ICU admissions, ICU interventions, total direct healthcare costs); COVID-19 severity; mortality.
Description: Lay Summary
COVID-19 is a respiratory disease caused by infection with the severe acute respiratory syndrome-coronovirus-2 (SARS-CoV-2). Since the first confirmed case in the United Kingdom in January 2020, around 865,000 people have been hospitalised and more than 195,000 have died with COVID-19 as of May 2022.
Technical Summary
COVID-19 can place people at higher risk to other infections, such as from bacteria, other viruses or fungus (BVF). BVF infections during or in the period after COVID illness are observed in approximately 19% of patients with a COVID-19 diagnosis. Patients with COVID who get a BVF infection are at a higher risk of severe COVID or death, with healthcare costs likely to be much higher than those who do not get a BVF.
Several studies have reported healthcare use and costs in COVID-19 patients, but there is little known about the costs associated with BVF infections and within groups at higher risk to COVID-19. By understanding the frequency of secondary BVF infections, as well as the healthcare use and health outcomes among patients with and without a BVF infection, we may be able to inform future studies and healthcare policy to target interventions among those with COVID.Aim: To use UK primary care data linked to secondary care data to describe the frequency of bacterial viral and fungal (BVF) infections associated with COVID-19 and to describe health outcomes among patients with and without a secondary BVF infection, in patients hospitalised or managed in the community in England.
Objectives: To: i) estimate incidence of COVID-19 associated BVF infections; ii) estimate mortality in COVID-19 patients with and without BVF infections; iii) quantify HCRU and associated direct healthcare costs in COVID-19 patients with and without BVF infections; iv) describe COVID-19 patient characteristics in those with and without a BVF infections, and v) describe COVID-19 severity in COVID-19 patients with and without BVF infections.
Objectives will be stratified by patient groups at risk of severe COVID-19 outcomes and reported in hospitalised, non-hospitalised and primary care patient cohorts.
Methods: A retrospective cohort study using UK primary care data (CRPD Aurum), linked to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) datasets, of confirmed COVID-19 patients with and without BVF infections during the study index period (August 2020âMarch 2022).
Exposures: COVID-19 episode; BVF infections; chronic respiratory conditions; risk of severe COVID-19, morbid obesity, diabetes, severe mental health, chronic vascular disease, ethnicity, â¥70 years and period of COVID-19 variant dominance.
Outcomes: BVF infections; HCRU (primary care consultations, hospitalisations, ICU admissions, ICU interventions, direct healthcare costs, re-admissions); COVID-19 severity; mortality
Data Analysis: Counts, means, medians, standard deviation and 25th/75th percentile values for continuous variables; relative frequencies and proportions/percentages for categorical variables.
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Epidemiology, treatment patterns, and healthcare resource utilization of patients with Essential Tremor: A retrospective cohort analysis in the United Kingdom — Marco Ghiani ...
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Epidemiology, treatment patterns, and healthcare resource utilization of patients with Essential Tremor: A retrospective cohort analysis in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-19
Organisations:
Marco Ghiani - Chief Investigator - Ingress-health HWM GmbH
Evi Zhuleku - Corresponding Applicant - Ingress-health HWM GmbH
Karen Appiah - Collaborator - Cytel Statistical Services and Software UK Limited
Keltie McDonald - Collaborator - Cytel Statistical Services and Software UK LimitedOutcomes:
Primary outcomes: Point prevalence at the end of each calendar year from 2010 to 2021; Cumulative incidence in each calendar year from 2011 to 2021;
Key secondary outcomes: Patient characteristics of the prevalent and newly diagnosed ET populations; Pharmacological and non-pharmacologic treatment use among the prevalent and newly diagnosed ET populations; Treatment sequences among the newly diagnosed ET population; Time-to-event outcomes including time to treatment initiation, discontinuation, switch, and non-persistence; GP/nurse consultations and extrapolated costs; All-cause and ET-related outpatient hospital specialist visits and extrapolated costs; All-cause and ET-related hospitalizations and extrapolated costs; ET-related prescriptions and extrapolated costs; Top inpatient/outpatient procedures; outpatient specialties of ET treating/diagnosing physiciansDescription: Lay Summary
Essential tremor is a common nervous system disorder affecting movement and the usual function of parts of the body, as well as the awareness and thinking capabilities. It is estimated that around 1,000,000 people in the UK have it. It is understood the number of patients affected may be even higher than previously reported, largely because of issues with the diagnosis of patients, and challenges relating to treatment. Therefore, there is a need for a more thorough understanding of the effect and management of patients outside of clinical trials and in the real world.
This study will look back at anonymous GP or hospitals records of patients diagnosed with essential tremors between 2010 and 2021 in the UK. In doing this, an up-to-date overview of the disease will be provided by describing the characteristics of patients diagnosed with the disease and also provide a summary of the treatments they received after their diagnosis. Furthermore, the resources that were used as part of patient care, as well as the costs of patient care will be investigated. The findings from our study will inform on the extent of the burden of essential tremors in the UK, which will be useful in bringing public health awareness as well as guide the strategies in improving care and management of patients suffering from the disease.
Technical SummaryThere is an increasing need for a comprehensive understanding of the effect and management of essential tremor (ET) in the real-world. This study aims to characterise ET patient profiles by describing i) epidemiology, ii) patient characteristics and treatment patterns iii) healthcare resource utilization (HCRU) and costs, and iv) specialties of diagnosing/treating physicians. Exploratorily, we will investigate (i) mortality (ii) comorbidity and cardiovascular risk profile and (iii) incremental HCRU and cost burden compared to a matched healthy cohort.
This retrospective cohort study will use primary care data from CPRD Aurum, independently (epidemiology) or linked to secondary care (HES Outpatient and Admitted Patient Care) from 01/01/2010-31/12/2021 (CPRD only; 31/03/2021 linked to HES; or latest available). Patients with a confirmed ET diagnosis will be analysed, conditional on fulfilment of selection criteria.
Yearly ET epidemiology (point prevalence [2010 to 2021] and cumulative incidence [2011 to 2021]) will be determined and estimates standardized by age/sex will be extrapolated to the overall UK population. Patient characteristics will be summarized using appropriate descriptive statistics in the 12-month baseline period or follow-up post-diagnosis as applicable. Treatment use will be evaluated from 2010 to 2021 among the prevalent population and post-diagnosis for an overall newly diagnosed cohort, among which treatment sequences will be visualized using Sankey diagrams. Kaplan Meier analyses will describe time to treatment discontinuation, switch, non-persistence, and overall survival. HCRU and costs (extrapolated) post-ET diagnosis will be described longitudinally and cross-sectionally in the latest available calendar year. Following propensity score matching of the newly diagnosed ET cohort to a healthy cohort without ET, the incremental burden of ET will be assessed.
Completion of the proposed study will result in various public health benefits, including an up-to-date real-world epidemiologic profile and characterisation of patients with ET in the UK, describing the burden of disease and elucidating unmet needs.
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External validation of longitudinal predictive models of health-related outcomes in patients older than 65 years of age — Sara Khalid ...
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External validation of longitudinal predictive models of health-related outcomes in patients older than 65 years of age
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-07
Organisations:
Sara Khalid - Chief Investigator - University of Oxford
LucÃa Carrasco-Ribelles - Corresponding Applicant - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of OxfordOutcomes:
All-cause mortality;
Multimorbidity pattern;
Admissions due to heart failure (ICD-10 code: I50), cerebral infarction (ICD-10 code: I63), and "other chronic obstructive pulmonary diseases" (ICD-10 code: J44, please see https://icd.who.int/browse10/2019/en#/J44)Description: Lay Summary
Predictive models are being developed using Artificial Intelligence (AI) in different fields, also in healthcare. Some AI techniques can consider how the patientâs information has changed over time when obtaining the predictions, improving their performance as more follow-up time is available. IDIAPJGol, a primary care research institute from Catalonia, Spain, has developed models that can predict all-cause mortality, combination of chronic diseases, and hospital admissions one, three, and five years in advance, using data from all the Catalan over-65s population during 10 years of follow-up. These models can be used both at patient level, to adjust therapy and seek to improve quality of life according to predicted outcomes, and at the administrative level, to adjust human resources and infrastructure planning. However, the performance of these models is at the moment only attributable to the Catalan population. The aim of this project is to validate them using data from the United Kingdom (UK) population, to measure how these modelsâ performance changes on other populations in general, and on the UK population in particular. For this purpose, the sample of UK population available in CPRD meeting the same eligibility and follow-up criteria as in Catalonia will be selected and used to measure the modelsâ performance. After this validation, the models will be specialised using this sample. As a result, these models, once optimised for the UK population, can be used in the UK population in the same way as in Catalonia, both at the patient and administrative levels.
Technical SummaryThe aim of this project is to externally validate three AI-based predictive models of all-cause mortality, multimorbidity pattern, and hospital admission one, three and five years in advance. These models were developed by IDIAPJGol (Catalonia, Spain), a primary care research institute, using primary care electronic health record data from 10 years of follow-up of the over-65s in Catalonia, and funded by ISCIII. They are based on recurrent neural networks, that are able to consider the evolution over time of the patients, and incorporate attention mechanisms to evaluate the importance of each variable at the individual level when obtaining each prediction. Their performance is only attributable to this population, so new data from a different population are needed to test its validity in other populations.
Once the same population is defined in CPRD data, i.e. individuals aged 65 and over in the period 2010-2019, the variables needed for the model will be calculated. The performance of the model in this population will then be calculated. Second, the existing models will be trained for a few more epochs using the CPRD data, aiming to specialise them in the UK population. This is also known as transfer learning. Differences in the performance will be studied considering the population differences between the Catalan and the CPRD populations, and the use of transfer learning. Finally, a guide for using and adapting these models to other information systems will be created, using the experience gained from validation with CPRD data, reporting mainly on how the data need to be adapted, how the models should be loaded and the predictions obtained.
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Comparative effectiveness of glucagon like peptide 1 receptor agonists versus sodium-glucose co-transporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors on hemoglobin A1C and body weight among people with type-2 diabetes and chronic kidney disease — Alice Clark ...
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Comparative effectiveness of glucagon like peptide 1 receptor agonists versus sodium-glucose co-transporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors on hemoglobin A1C and body weight among people with type-2 diabetes and chronic kidney disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-30
Organisations:
Alice Clark - Chief Investigator - Novo Nordisk A/S
Alice Clark - Corresponding Applicant - Novo Nordisk A/S
Anders Boeck Jensen - Collaborator - Novo Nordisk A/S
Katherine Tuttle - Collaborator - University Of Washington
Kathrine Valentini Jensen - Collaborator - Novo Nordisk A/S
Nicolas Belmar Nazal - Collaborator - Novo Nordisk A/S
Paola Fioretto - Collaborator - University of Padova
peter rossing - Collaborator - University of CopenhagenOutcomes:
Primary outcomes: 6 months changes in HbA1c (%-point); 6 months change in body weight (in kilo grams and %-change).
Applied codes are listed in Appendix 2.Secondary outcomes: the proportion of people with an HbA1c <7% at 6 months, among those above that threshold at initiation of study drugs; a body weight reduction of >5% at 6 months among people with overweight or obesity at initiation of study drug.
Description: Lay Summary
Although a multitude of treatment options exist for management of blood sugar and body weight in people with diabetes (persistently high blood sugar), little is known about potential effective treatments for people with both diabetes and chronic kidney disease â especially with more severe kidney impairment, where few treatment options exist. This lack of knowledge could lead to a general reluctance among treating physicians to prescribe potentially effective treatments in these patients.
Therefore, the aim of this study is to investigate the effectiveness of different diabetes treatment alternatives in people with diabetes and impaired kidney function in lowering blood sugar and reducing body weight.
This evidence will serve to guide treating physicians as well as people with both diabetes and impaired kidneys in the choice of effective treatments to manage their diabetes.
Technical SummaryThere is limited evidence concerning effective and safe therapies for type-2 diabetes (T2D) management in people with chronic kidney disease (CKD). While guidelines exist for some glucose lowering agents (GLA), evidence is lacking for other potential safe and effective treatments. The lack of knowledge may induce therapeutic inertia with treating physicians, with resulting adverse consequences for patients receiving suboptimal care.
While the limited evidence supports safety and tolerability of glucagon like peptide-1 receptor agonists (GLP-1) in people with CKD, studies are lacking on the comparative effectiveness to other GLAs.
The objective of this study is, through an active comparator new user design, to determine the comparative effectiveness of GLP-1 vs. GLA alternatives in T2D patients with CKD on 6-months change in haemoglobin A1c (HbA1c) and body weight (BW). More specifically comparing:
A) GLP-1 vs. sodium/glucose cotransporter-2 inhibitors in people with T2D & eGFR 30 to 60 mL/min/1.73m2.
B) GLP-1 vs. dipeptidyl peptidase 4 inhibitors in people with T2D & eGFR <60 mL/min/1.73m2.Adult new users of study GLAs diagnosed with T2D and an eGFR <60 within one year prior to initiation of GLA will be identified in CPRD Aurum between 2007 and 2022 and included for analysis if they also fulfil the following; minimum 1 year observation time prior to initiation of study GLA, have data on HbA1c and/or BW within three months prior to and within 6 months following initiation of study GLA.
Mixed models with repeated measures using baseline and all available follow-up measurements will be used to estimate change in HbA1c and BW. HbA1c will be modelled using restricted cubic splines. Random subject coefficients for intercept and slope with respect to time will be included. Propensity score will be used to account for confounding through inverse probability of treatment weights or matching depending on the data.
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Risk of cardiovascular events according to treatments patterns in patients with autoimmune disorders — billy amzal ...
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Risk of cardiovascular events according to treatments patterns in patients with autoimmune disorders
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-09
Organisations:
billy amzal - Chief Investigator - RE-MED France SAS
Tom Duchemin - Corresponding Applicant - RE-MED France SAS
Yann Hamon - Collaborator - RE-MED France SAS
Yola Moride - Collaborator - RE-MED France SASOutcomes:
Primary outcome
Any of the following CV events leading to hospitalization or emergency management:
A. Inflammatory CV events: pericarditis (of non-infectious origin), myocarditis, and endocarditis.
B. Thromboembolic events: myocardial infarction, acute coronary syndrome, stroke (ischemic and hemorrhagic) or transient ischemic attack (TIA), and venous thromboembolism or pulmonary embolism.
C. Arrhythmias: atrial fibrillation and flutter, and supraventricular arrhythmias or conduction system disease.
D. Other CV disorders: aortic aneurysm, peripheral arterial disease, valve disorders (excluding congenital and rheumatic), and heart failure.Key secondary outcomes
- Immunologic CV events, thromboembolic events, arrhythmias or other cardiac diseases (A, B, C or D CV events above) will be studied separately;
- Use of CS will be studied as an outcome in a secondary analysis.Description: Lay Summary
This study focuses on autoimmune disorders, which are very serious conditions affecting over 1 million patients in the UK. Among others, they include diseases like multiple sclerosis and rheumatoid arthritis. Over time, these conditions often result in heart diseases, strokes or blood clots. This study seeks both to assess how often these complications occur, and to determine the impact of specific pharmaceutical treatments on the frequency of such complications. Understanding how certain medications can trigger cardiovascular conditions in patients with autoimmune disorders will help reduce, and in some cases even prevent, the development of such life-threatening side effects. We estimate that it could benefit thousands of patients in the UK and throughout the world.
More specifically, this study will focus on the following autoimmune disorders: Addison's disease, ankylosing spondylitis, coeliac disease, type 1 diabetes, inflammatory bowel diseases, myasthenia gravis, multiple sclerosis, pernicious anemia, polymyalgia rheumatica psoriasis, primary biliary cirrhosis, rheumatoid arthritis, Sjögren's syndrome, systemic sclerosis, systemic lupus erythematosus, thyroid diseases, vasculitis, and vitiligo.
Technical SummaryA recent CPRD study of Conrad et al. (2022) showed an elevation of the incidence of a dozen cardiovascular (CV) events in 19 autoimmune diseases (AIDs) and showed a decline in the relative risk associated to AIDs from 1.6 in 2000-2004 to 1.24 in 2015-2019 [1]. The contribution of different AIDs-targeted medications on this CV risk and its decline is still unknown and under investigated. The objective of this study is to assess whether the recommended lower use of non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (CS) in AID patients occurred and translated into a decline of CV risk in the UK in 2000-2022. We will also evaluate the contribution of the following groups of AIDs targeted drugs to the CV risk and its decline: synthetic antimalarial drugs, methotrexate, classical immunosuppressants, and biotherapies. For that purpose, a cohort of incident patients with the 19 main AIDs will be followed from 2000 to 2022 in CPRD Aurum and GOLD linked to HES datasets.
The relative risk of CV events according to the amount of CS and NSAIDs use over time will be assessed in a logistic regression controlling for age, sex, comorbidities, and socioeconomic status, also controlling for other treatments and risk factors use. To study the CV risk linked to the use of different type of AID treatment, new drug users of hydroxychloroquine, methotrexate, classical immunosuppressive drugs (all) and biotherapies (all) will be matched to patients from the AIDs cohort without the use of these drugs at the same period. Matching will be done on individual disease, sex, age, high dimensional propensity scores, and stage of the disease. A Cox proportional hazards model adjusted for socioeconomic status and time-varying non CV comorbidities will assess the hazard rate of CV events for each group of AIDs-targeted drug users as compared to non-users.
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Investigating the epidemiology of peripheral nerve injury (PNI) and the prescription pattern of medication for PNI patients in UK: a longitudinal observational study — Kenneth Man ...
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Investigating the epidemiology of peripheral nerve injury (PNI) and the prescription pattern of medication for PNI patients in UK: a longitudinal observational study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-30
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Alaa Alhamdi - Corresponding Applicant - University College London ( UCL )
James Phillips - Collaborator - UCL School Of Pharmacy
Melissa Rayner - Collaborator - University College London ( UCL )Outcomes:
1) Annual incidence of PNI.
2) Annual hospitalisation rate of PNI patients.
3) Descriptives of patients with PNI: demographic patient data including gender and age.
4) Incidence and prevalence of prescribed medication.
5) Healthcare resources utilization by calculating the number of hospital /GP visitsDescription: Lay Summary
Peripheral nerve, nerve that lies outside your brain and spinal cord, injury (PNI) is a global health issue that often results in significant disability and socio-economic burden. Common causes include motor vehicle accidents, injuries, birth complications, diabetes, and cancer treatments. PNI predominantly affects working-age men between 18 to 35 years. Currently, PNI is primarily treated through surgery, with the U.S. spending billions annually on management, but there's no regular medication to aid nerve regeneration.
Our research aims to better understand PNI and its treatment. Using anonymous medical records from the UK, we'll examine the demographic profile of PNI patients and the medications prescribed to them. We'll also evaluate the effectiveness of these medications.
This study will provide insights into the population affected by PNI and current drug treatment strategies. By comparing treatment outcomes, we can inform evidence-based decisions on PNI treatment, aiding the development of improved therapeutic strategies. This research could potentially help reduce the significant economic and healthcare burden of PNI.
Technical SummaryWe will use data from the Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) to conduct a longitudinal observational population-based study including patients aged under 60 years old, and diagnosed with one or more peripheral nerve injury (PNI) in the upper and/or lower extremities between 2000 to 2023.
Our objective is to evaluate the annual incidence of PNI, and the number of PNI patients hospitalized per year during the study period. We also aim to describe the clinical characteristics of individuals with PNI. Medications prescribed to PNI patients after the PNI event will be identified and summarised. A comparison of the healthcare resources utilization of different prescribed medications for PNI patients will also be evaluated based on the hospital /GP visits and medication usage by patients.
In our analysis, we will use the Poisson regression to compare the PNI incidence and hospitalization rates of PNI over the study period. To analyse the clinical characteristics of individuals with PNI, the chi-square test will be used for categorical variables such as gender and type of PNI, while continuous variables such as age, t-test will be applied. Poisson regression will also be applied to compare the average number of hospital/GP visits among PNI patients prescribed different medications.
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Association between menopause and prognosis in dilated cardiomyopathy — Upasana Tayal ...
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Association between menopause and prognosis in dilated cardiomyopathy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-13
Organisations:
Upasana Tayal - Chief Investigator - Imperial College London
Upasana Tayal - Corresponding Applicant - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Emily Graul - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College LondonOutcomes:
Non fatal cardiovascular outcomes of: heart failure hospitalisation, non fatal myocardial infarction, atrial fibrillation, stroke, non fatal cardiac arrest
Description: Lay Summary
Heart failure affects 26 million people globally. It is a leading cause of hospitalisations and early deaths and a major economic burden, making up 1-2% of the NHS budget. A common cause is dilated cardiomyopathy, a heart muscle condition that affects up to 1 in 250 people, or 240,000 people in the UK. Unfortunately, despite best treatment, mortality for this relatively young population (median age 40) remains high. We urgently need to improve how we care for patients with this condition.
Biological sex (being male or female) may play a critical role in disease. My research shows that:
(i) Dilated cardiomyopathy affects twice as many men as women. Either men are more at risk or women are protected.
(ii) The hearts of men and women with dilated cardiomyopathy differ - women have smaller hearts and better heart function.
(iii) Women get twice as many complications after the age of 50 whilst men have the same number of complications regardless of age. This suggests that women are more at risk of complications despite a 'milder' disease and this risk increases after menopause.Despite these observations, we currently treat men and women exactly the same.
Women experience a number of unique life events linked to major hormonal changes such as menopause. However, we do not know the impact of menopause on dilated cardiomyopathy or its complications. Determining how and why dilated cardiomyopathy differs in men and women will help us to make sense of the range of health outcomes that patients experience.
Technical SummaryBackground: Dilated cardiomyopathy is a leading cause of heart failure, affects up to 1/250 people, and has a 20% 5 year mortality. The contribution of biological sex is poorly understood.
Aim: To evaluate the impact of menopause on dilated cardiomyopathy prognostic risk.
Objective: Evaluate whether menopause is associated with an increased risk of adverse cardiovascular outcomes amongst patients with dilated cardiomyopathy.
Methodology:
Self -controlled case series of women with dilated cardiomyopathy pre and post menopause (exposure variable- menopause), adjusting for hormone replacement therapy use, socioeconomic status, heart failure medication use (ACE inhibitors, beta blockers, ARNIs, aldosterone antagonists, diuretics), GP practice and comorbidities of diabetes and hypertension and follow up for non-fatal adverse cardiovascular outcomes (heart failure hospitalisation, non-fatal myocardial infarction, atrial fibrillation, stroke, non-fatal cardiac arrest). Observation periods will be divided according to age groups. Cases will be determined using CPRD data as well as HES admitted patient care data. As an additional analysis to explore the effect of age as opposed to menopause itself on outcomes, a similar study in the male cohort will be conducted using a dummy variable at the median age of onset of menopause (age 51).This work will lead to improved understanding of the effect of sex specific variables as cardiomyopathy risk factors to improve diagnostic strategies and identification of previously unrecognised at-risk populations (e.g. perimenopausal women).
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Risk factors, development of complications, and mortality in individuals with type 1 and type 2 diabetes — Francesco Zaccardi ...
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Risk factors, development of complications, and mortality in individuals with type 1 and type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-13
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Alessandro Rizzi - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Navjot Kaur - Collaborator - University of Leicester
Setor Kunutsor - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of LeicesterOutcomes:
Fatal and non-fatal complications that have been deemed relevant in the investigations of multimorbidity, including but not limited to cardiovascular, neurological, respiratory diseases, and cancers: this decision aligns with a recent consensus on multimorbidity.[1] The absolute and relative risks of these complications over time, as well as of mortality, will be estimated within each of, and compared across, the three sub-cohorts an compared to the general population and a CPRD cohort of individuals without diabetes.
Description: Lay Summary
Diabetes is a long-term illness that causes high blood sugar levels. There are two main types of diabetes: type 2 diabetes (T2D), which occurs in middle-aged persons; and type 1 diabetes (T1D), which generally occurs at young ages; both types of diabetes increase the risk of several diseases, in particular of the heart (for example, heart attack).
However, the development of complications may differ between the two types of diabetes: for example, diseases may occur more frequently in T2D than T1D. Moreover, also the type of the complications may vary, for example heart attacks may be more common in T2D than T1D. At the same time, other factors, which are generally known as "risk factors" (such as obesity, high blood pressure, or the duration of diabetes), may also play a different role in the development of the diseases or the risk of death between the two types of diabetes. Therefore, it is important to detail the risk of developing different disease in relation to the risk factors and to the type of diabetes, and to compare this risk to people without diabetes.
Using information collected by primary care doctors, this study aims to describe the trajectories of the risk factors, diabetes diseases, and the risk of death in individuals with T1D, T2D, and without diabetes, and to explore the effect of the risk factors on the development of the diseases and death.
Technical SummaryTo date, there are no available studies which have detailed the natural history of diabetes complications from diabetes diagnosis in individuals with T1D and T2D, and how this history is influenced by the characteristics of the patients. Using CPRD data linked to HES APC and ONS, the current study will investigate the development of a single and multiple diseases in individuals with T1D and T2D, and compare the longitudinal trajectories between diabetes types and to people without diabetes. In particular, risk factors (i.e., body mass index, deprivation, glucose control, smoking, duration of the diseases) will be evaluated when the disease is diagnosed (and in the matched control population) and during the evolution of the disease, within each of the three sub-cohorts (T1D, T2D, no diabetes) and in comparisons across sub-cohorts. The relative and absolute risk of developing a single disease (monomorbidity) and multiple diseases (multimorbidity) will be quantified within each sub-cohorts and differences between sub-cohorts estimated. Furthermore, the associations between the (time-varying) risk factors on the transitions across complications and mortality will be estimated. The results of these investigations are of public health relevance, given the rise in the incidence and prevalence of diabetes (particularly type 2 in younger ages), the longer life expectancy in individuals with diabetes, and the potential resulting greater burden of multimorbidity in this population. Defining the temporal development of different complications could indeed guide the implementation of strategies (for example, screening) to identify earlier the risk of specific complications, allowing an early treatment to reduce the risk of mortality. Furthermore, these results may be used to estimate the cost-benefit of population-wide strategies to reduce the burden of multimorbidity in complications in individuals with diabetes.
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Sex-specific differences in cardiovascular risk factors, risk factor management, treatment compliance and major cardiovascular outcomes in the peripheral arterial disease population — Anna Louise Pouncey ...
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Sex-specific differences in cardiovascular risk factors, risk factor management, treatment compliance and major cardiovascular outcomes in the peripheral arterial disease population
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-16
Organisations:
Anna Louise Pouncey - Chief Investigator - Imperial College London
Anna Louise Pouncey - Corresponding Applicant - Imperial College London
Colin Bicknell - Collaborator - Imperial College London
Jaet Powell - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Mark Cunningham - Collaborator - Imperial College London
Mark Woodward - Collaborator - Imperial College London
Safa Salim - Collaborator - Imperial College LondonOutcomes:
⢠Major Adverse Cardiovascular Event or Death:
defined as any of the following:
(A) Critical limb ischaemia, intervention/bypass, or amputation,
(B) Aortic repair or rupture,
(C) Major cardiac event â myocardial infarction,
(D) Ischaemic stroke or carotid surgery,
(E) Diagnosis of vascular dementia
AND/OR (all cause or cardiovascular) mortality.⢠Progression of disease (PAD or IHD) to end organ damage, with adjustment for baseline disease severity at index data entry, please see appendix 1.
Description: Lay Summary
Cardiovascular disease, (namely disease of the blood vessels supplying the heart, body and brain,) is often regarded as a manâs problem, but is also the main cause of death for women.
Certain medical conditions and lifestyle choices (so called ârisk factorsâ) increase the risk of cardiovascular disease. When they are spotted, they can often be treated to prevent further illness and death. These include âtraditionalâ risk factors, such as high blood pressure and smoking, as well as newly recognised conditions, which may be more common in either women or men.
We have noticed that women with peripheral arterial disease, (disease in blood vessels supplying the stomach, arms and legs) often do worse than men. This may be due to differences in their risk factors and treatment. For this study we will use depersonalised (non-identifiable) data collected from medical records, in particular data from GPs (general practitioners), to look at the differences in risk factor treatment and the importance of risk factors for men and women.
Understanding the differences in risk factors and their management, for men and women, could help us to spot and treat them more successfully. This could reduce the burden of cardiovascular disease for people in the future.
Technical SummaryBackground:
Morbidity from peripheral arterial disease (PAD) causes a worldwide health economic burden and is associated with morbidity and death from other cardiovascular disease (CVD). Women with PAD fare worse than men. This may occur due to differences in recognition and management of CVD risk, for traditional and non-traditional risk factors (NTRF). These differences are poorly understood.Aims:
To investigate the hypotheses that:
(1) sex specific differences in cardiovascular risk management leads to disparity in disease progression, major cardiovascular events, and death, amongst those with PAD
(2) non-traditional risk factors contribute to sex-specific differences observed.Methods:
A retrospective population-based cohort study using linked de-personalised electronic healthcare records (Clinical Practice Research Datalink, Hospital Episode Statistics, Index of Multiple Deprivation, Office of National Statistics), 2010-2020. Evaluation of cardiovascular risk management received by women and men with PAD, and impact on clinical outcomes, adjusting for traditional and non-traditional risk factors. Longitudinal assessment of patients with pre-selected NTRFs, identified prior to diagnosis of CVD, (comparing to age-matched controls), to establish associated risk of PAD.Impact:
Understanding the impact of sex-specific differences in recognition and management of CVD risk will enable quality improvement in risk stratification and treatment for the PAD cohort, especially for women.
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Comparative safety of prescription opioids and prediction of opioid-related adverse events in patients with non-cancer pain — Meghna Jani ...
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Comparative safety of prescription opioids and prediction of opioid-related adverse events in patients with non-cancer pain
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-20
Organisations:
Meghna Jani - Chief Investigator - University of Manchester
Meghna Jani - Corresponding Applicant - University of Manchester
Carlos Raul Ramirez Medina - Collaborator - University of Manchester
Glen Martin - Collaborator - University of Manchester
Ramiro Bravo - Collaborator - University of Manchester
William Dixon - Collaborator - University of ManchesterOutcomes:
Adverse events (AEs) associated with prescription opioids: serious infection, cognitive adverse events including dementia and delirium, fractures and gastrointestinal outcomes (constipation, bowel obstruction), long-term opioid use, non-fatal opioid overdose, opioid-dependence and deaths
Description: Lay Summary
Opioid use including prescription opioids (such as codeine, tramadol, oxycodone) for non-cancer pain and related harmful effects have reached epidemic proportions in the US and Canada, with rising trends in the UK. Opioid users may be particularly vulnerable to related harms due to factors including older age, existing health-conditions and drug-interactions. However, there are limited alternative options for pain-relief medicines. Therefore, depriving everyone of opioids is not a solution. A better understanding of patient and prescribing characteristics where harms outweigh the benefits is imperative for informed decision-making and safe prescribing. Currently it is unclear which patients are at the highest risk of opioid-related harms and who could be safely prescribed them. This project is timely because advances in methods are now available to allow important questions to be addressed that was not possible previously. Two main aims are addressed: (i) Within the class of opioids, are there certain drugs with a higher risk of death and serious side effects? Specifically, how do these change with dose, strength and when taken with other medications? (ii) Individual prediction: Given everything known about a patient, if they start taking an opioid at a particular dose what their risk of developing a serious side-effect? The results will be directly relevant to clinicians, patients, public health, policy makers to drive improvements in outcomes and future prescribing.
Technical SummaryOpioid use for non-cancer pain has been increasing over the last 15-20 years in North America and Europe and has emerged as a major public health concern in the last decade. Opioids are associated with multiple non-serious and serious harms that can lead to hospitalisation. Much of the literature focuses on opioid safety as a class on a population level, however important pharmacokinetic and pharmacodynamic differences between opioids can affect their safety and potential for dependence. Currently a âone size fits allâ prescribing approach is employed, as it is not clear which patients may develop opioid-related harms and what treatment regimens predispose to worse outcomes. Clinical prediction models (CPMs) are statistical tools/algorithms that use patient information to predict the risk of outcomes of interest. However, CPMs for prediction of opioid-associated harms are scarce, and where they exist are developed only for one safety outcome and not used in clinical practice. This approach fails to capture multi-safety outcome patterns evolving over time.
Aims of this project are: (1). To evaluate the comparative safety of opioids for serious and non-serious adverse events, considering the dose, potency and duration (2). To develop prediction models for key opioid-associated safety outcomes. CPRD Gold and Aurum will be linked to Hospital Episode Statistics, deprivation indices and Office of National Statistics data. To develop prediction models for key opioid-associated safety outcomes. Cox-proportional hazard models will be used, with outcome specific methods to adjust for confounding factors. Novel methods for developing multi-outcome prediction models will be used alongside traditional predictive modelling for individual risk prediction. This work will unpick some of the complexities of opioid-associated adverse event moving from risk estimation towards personalised risk. The results will be directly relevant to clinicians, patients, public health, policy makers to drive improvements in outcomes and future prescribing.
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Diagnostic pathways and healthcare resource utilisation of polycystic ovary syndrome patients in the United Kingdom — Rana Maroun ...
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Diagnostic pathways and healthcare resource utilisation of polycystic ovary syndrome patients in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-27
Organisations:
Rana Maroun - Chief Investigator - Roche Diagnostics International Ltd
Rana Maroun - Corresponding Applicant - Roche Diagnostics International Ltd
Anne Connolly - Collaborator - NHS England
Johanna Sillman - Collaborator - Roche Diagnostics International Ltd
Joy Allen - Collaborator - Roche Diagnostics Ltd (UK)
Julia Eades - Collaborator - Roche Diagnostics International Ltd
Osvaldo Ulises Garay - Collaborator - Roche Diagnostics International Ltd
Ryan Walkley - Collaborator - Roche Diabetes Care, Inc
Scott Nelson - Collaborator - University of Glasgow
Sraboni Sarkar - Collaborator - Roche Diagnostics International Ltd
SUWEI WANG - Collaborator - Roche Molecular Systems, IncOutcomes:
The following outcomes will be measured and reported:
Baseline socio-demographic and clinical characteristics of patients included in the cohort;
- Common symptoms of PCOS;
- Time from symptoms onset until diagnosis;
- Proportion of PCOS patients diagnosed by care setting;
- Proportion of the types of healthcare professionals involved in diagnosis;
- Most common procedures used in the diagnosis of PCOS;
- Incidence and prevalence of PCOS in CPRD;
- HCRU of patients with PCOS;
- Cost to the NHS;
- Proportion of probable PCOS cases defined as the proportion of women with PCOS features and no diagnosis of PCOS; and
- Regional variations in the diagnostic pathways as well variations by deprivation status and ethnicityDescription: Lay Summary
Polycystic ovary syndrome (PCOS) is a common condition that affects women throughout their lives causing a range of symptoms and complications such as irregular or absent periods, difficulties getting pregnant, hormonal imbalances, obesity, diabetes, skin problems and abnormal patterns of hair growth. As most of these symptoms are common among women of reproductive age, PCOS may go undetected or misdiagnosed for years, meaning many women wonât have support to manage their symptoms which can affect their quality of life. The purpose of this study is to understand how PCOS patients are diagnosed and managed, their clinical outcomes, and the use of healthcare resources such as whether the diagnosis was made by a general practitioner or in a hospital setting, how long it took for a diagnosis to be made, the medications prescribed and costs to the United Kingdom (UK) National Health Service. We will also estimate the number of established and newly diagnosed patients, and the most common symptoms patients experience at diagnosis. Our study will allow us to better understand the diagnostic journey of patients with PCOS. The findings from this study may be used to point out gaps in the diagnosis of patients with this condition and consequently help to reduce the physical and financial burden experienced by women in the UK with this condition.
Technical SummaryPCOS is a common endocrine disorder that is estimated to affect approximately 3-10% of women in the UK. PCOS is associated with a range of reproductive, metabolic, cardiovascular, and dermatologic symptoms including infertility, infrequent or absent menstrual periods, hirsutism (excessive hair growth), weight gain, and dermatological concerns. Given the heterogeneous nature of PCOS, and many of the symptoms being common among reproductive age women, a PCOS diagnosis is often delayed, involves multiple healthcare provider visits, or remains undiagnosed. The purpose of this study is to describe the diagnostic journey and management of patients with PCOS using UK CPRD linked to the England Hospital Episode Statistics (HES). We will conduct a retrospective cohort study of patients aged 15-49 years who have a confirmed or probable diagnosis of PCOS between January 1, 2003 and December 31, 2021. Data will be extracted from CPRD Aurum and linked to HES. The primary objectives of this study are to describe socio-demographic and clinical characteristics, describe the common symptoms at diagnosis, estimate the proportion of PCOS patients diagnosed by care setting and provider type, and describe the most common procedures used in the diagnosis of PCOS. Additionally, this study seeks to estimate the incidence and prevalence of PCOS in CPRD and to estimate the HCRU and costs in patients with a PCOS diagnosis. Patient demographics, clinical characteristics, diagnostic patterns, PCOS symptoms, and healthcare costs will be summarised using descriptive statistics. The findings from this study will allow us to better understand the diagnostic journey of patients with PCOS and subsequently may help to identify interventions or efficiencies that could reduce the physical and financial burden for women diagnosed with PCOS in the UK in the future.
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Examining comorbidities of patients with childhood onset rheumatic diseases: Juvenile Idiopathic Arthritis (JIA), Juvenile Lupus (jSLE) and Juvenile Dermatomyositis (JDM) — David Hughes ...
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Examining comorbidities of patients with childhood onset rheumatic diseases: Juvenile Idiopathic Arthritis (JIA), Juvenile Lupus (jSLE) and Juvenile Dermatomyositis (JDM)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-01
Organisations:
David Hughes - Chief Investigator - University of Liverpool
Sab Siddiq - Corresponding Applicant - University of Liverpool
Clare Pain - Collaborator - Alder Hey Childrenâs NHS Foundation Trust
Eve Smith - Collaborator - University of Liverpool
Sizheng Zhao - Collaborator - University of LiverpoolOutcomes:
Incidence and prevalence of JIA, jSLE and JDM in CPRD; prevalence and incidence rates stratified by age, sex, and IMD quintiles if there are sufficient cases in each of JIA, jSLE, and JDM; comparison of incidence and prevalence of 213 comorbidities (211 listed in Head et. al[1], and 2 new emerged from PPIE[2-4] events) in patients with JIA, jSLE, and JDM, and to those with none of these i.e., healthy controls corresponding to the same age, sex, and geographical region; age of onset of comorbidity related to the age of onset of the condition considering sex, race, ethnicity etc.
Results will be age- and sex- standardised using the European Standard Population 2013. Age related subgroups will be compared, including pre-pubertal patients (â¤7 years); peri pubertal (8-13 years) and adolescent (14-18 years) of age.Description: Lay Summary
Comorbidity refers to the co-occurrence of two or more diseases in an individual. For example, the diagnosis of heart disease, diabetes, etc. in patients with rheumatic disease.
We know that patients with adult-onset rheumatic disease are at increased risk of comorbidities. Those from deprived socio-economic backgrounds are worse affected. We also know that patients with childhood-onset of rheumatic diseases such as Juvenile Idiopathic Arthritis (JIA), Juvenile Lupus (jSLE) and Juvenile Dermatomyositis (JDM), are at risk of ongoing disease activity with a requirement to take medication and have increased risk of damage with greater disease activity in later life.
During Patients and Public Involvement and Engagement (PPIE) events, young people with juvenile-onset rheumatic disease discussed infections and infertility as being important to them, along with other recognised comorbidities such as heart disease, diabetes.This study, therefore, wants to investigate whether patients with childhood-onset rheumatic diseases (JIA, iSLE and JDM) may be at risk of increased risk of comorbidities. Also, to explore whether risk may vary according to the age of disease onset, socioeconomic status, disease activity. We are also interested in whether individuals with these diseases are more likely to get infections or be infertile, and to assess the effects of JIA/jSLE/JDM on an individualâs height over time. Data from General Practitioner (GP) records, hospital admissions, English deprivation data, and National statistics within the UK, will be used.
Technical Summary
Our findings would better inform patients with JIA/jSLE/JDM, families and carers, and clinicians in their treatment plans and decisions.This study aims to examine long-term comorbidities of patients with childhood-onset rheumatic diseases: Juvenile Idiopathic Arthritis (JIA), Juvenile Lupus (jSLE) and Juvenile Dermatomyositis (JDM). We also aim to investigate whether patients with these diseases have increased risk of infection/infertility compared to healthy controls, as well as to look at the risk of other comorbidities i.e., heart disease, diabetes. We will use the Clinical Practice Research Datalink (CPRD). CPRD is an electronic health record repository of General practitioner (GP) records, that represent a large longitudinal English primary care population. The CPRD data will be linked to Hospital Episode Statistics (HES) admission data for additional comorbidities, to the English Index of Multiple Deprivation (IMD) to calculate IMD quintiles for each outcome, and to Office for National Statistics (ONS) mortality records.
The objectives are to i) Describe the incidence of comorbidities commonly observed in JIA, jSLE and JDM, ii) Compare the prevalence of comorbidities in individuals with these conditions with those of a matched healthy controls, iii) Identify clusters of comorbidities for each juvenile rheumatic condition, iv) Explore how the prevalence of comorbidities in individuals varies by socioeconomic status in the UK using stratified sex, 10-year age group, and IMD quintiles, v) Analyse trajectories based on inflammatory markers i.e. C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Body Mass Index (BMI) after JIA/jSLE/JDM diagnosis using Latent Class analysis, vi) Assess infertility rates in patients who were diagnosed with JIA/jSLE/JDM compared to healthy controls using logistics regression. vii) Compare the rate of hospitalisation and death among JIA, jSLE and JDM patients due to infections using Cox proportional hazards regression.
The public health benefits would be to better inform patients with JIA/jSLE/JDM and their families and carers of the risks of these conditions, and aid clinicians in their treatment decisions.
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Using big data to investigate fetal and child outcomes following exposure to antiseizure medication in pregnancy — Anita McGrogan ...
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Using big data to investigate fetal and child outcomes following exposure to antiseizure medication in pregnancy
Datasets:GP data, Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-12
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Julia Snowball - Collaborator - University of Bath
Marte-Helene Bjork - Collaborator - Not from an Organisation
Rachel Charlton - Collaborator - University of Bath
Rebecca Bromley - Collaborator - University of ManchesterOutcomes:
Pregnancy loss; stillbirth; neonatal death; major congenital malformations; neurodevelopmental diagnoses; childhood cancer; maternal death.
Description: Lay Summary
The safety of newer medications to treat illnesses in pregnancy including the neurological condition, epilepsy, is uncertain. Women need to know more about medication safety when balancing benefits of treatment with risks to their unborn child. Studying medication safety in pregnancy is complicated by the need for large groups of women and their children, needing to capture rare events including functional anomalies in babies, that occur during pregnancy and the need to follow up children as they develop over time.
These are challenges that can be addressed by using data collected through routine healthcare appointments. By using this approach we can provide important evidence to women and healthcare professionals making challenging decisions about treatment. This study will include women with a medication prescribed to prevent seizures before or during pregnancy. Comparisons will be made between different treatment groups.
We will use information recorded about pregnancy management including medications prescribed and we will find out whether their pregnancy ended with a loss or a livebirth. We will link the records of the mothers and their children to allow us to collect information about development and diagnoses. Outcomes in children will be compared between mothers who used different medications during pregnancy. This work will improve the care of women in their childbearing years through providing information both women and their doctors need to make pregnancy as safe as possible for the mother and child.
Technical SummaryWomen with epilepsy or other chronic conditions may need to take antiseizure medications in pregnancy to prevent seizures or alleviate other symptoms. There is limited evidence about the safety of the newer antiseizure medications in pregnancy. This work aims to understand prescribing and safety of antiseizure medications in pregnancy to better inform patients and healthcare professionals in planning pregnancies.
This study will use anonymised data from CPRD AURUM. The study period will run from 01-Jan-2002 to 31-June-2021. Women with a prescription for an anti-seizure medication prescribed before or during pregnancy will be identified. Prescribing of antiseizure medications will be described by one month time periods in terms of mono and polytherapy; any switching or cessation of medications will be described. Comparisons will be made between pregnancies with a prescription for lamotrigine during pregnancy and pregnancies where a different antiseizure medication(s) was prescribed. Outcomes to be investigated include pregnancy loss, stillbirth, early neonatal death, maternal death and in the offspring, major congenital malformations, neurodevelopmental outcomes and childhood cancer.
Analyses will be grouped by indication for prescribing of antiseizure medications: women who have an epilepsy diagnosis before pregnancy; women who have an alternative or no indication for prescribing an antiseizure medication. Absolute risks of each outcome will be reported with 95% confidence intervals; conditional logistic regression will be used to evaluate major congenital malformations and survival analysis will be used to evaluate pregnancy loss, stillbirth, neurodevelopmental disorder outcomes and childhood cancer. Analyses will compare different antiseizure medications as mono and polytherapy and at different dosages; adjustments for confounders will be made and sensitivity analyses will test potential misclassification of exposure and outcomes.
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Infectious disease mortality among people with severe mental illness: Retrospective analysis of a national representative sample — Amy Ronaldson ...
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Infectious disease mortality among people with severe mental illness: Retrospective analysis of a national representative sample
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-23
Organisations:
Amy Ronaldson - Chief Investigator - King's College London (KCL)
Amy Ronaldson - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Ioannis Bakolis - Collaborator - King's College London (KCL)
Jayati Das-Munshi - Collaborator - King's College London (KCL)
Temi Lampejo - Collaborator - King's College London (KCL)Outcomes:
Infectious disease mortality from linkage with ONS mortality data (primary outcome); hospitalisations for infectious disease from linkage with HES hospital admission data (secondary outcome). (RQs 1, 2, and 3)
Deaths and hospitalisations from infectious disease will be identified using the following ICD-10 codes: central nervous system (CNS) infections (A17, A80-A81, A85-A89, B00.3-B00.4, B01.0-B01.1, B02.0-B02.2, B05.0-B05.1, B06.0, B2.61-B26.2, G00-G01, G02.0, G03, G04.2, G05.0-G05.1, e.g., meningitis, viral encephalitis), gastrointestinal infections (A00-A05, A08, e.g., salmonella, shigellosis), liver infections (B15-B19, e.g., hepatitis A), respiratory infections (A15-A16, A36-A38, J00-J06, J09-J18, J20-J22, e.g., pneumonia, laryngitis), sepsis (A40-A41, e.g., streptococcal sepsis), skin infections (A46, B00-B09, L00-L05, L08, e.g., cellulitis, measles), urogenital infections (N30.0, N39.0, N41.0â41.1, N71-N72, e.g., cystitis, prostatitis), and other infections (A18-A19, A31-A32, A39, A42-A44, A48-A49, B25-B27, B30, B33-B34, B95-B99, H62.0-H62.1, H67.0-H67.1, M00, M01.0-M01.5, N61, e.g., bone infection, mastitis). We also plan to look at COVID-19 deaths and hospitalisations (U07.1, U07.2).
We hypothesise that certain infectious diseases might emerge as primary endpoints in this study. These include influenza (J09-J11), pneumonia (J12-J18), and sepsis (A40, A41).
SMI subtype (bipolar disorder; schizophrenia; other psychoses) will be determined using Read and SNOMED codes (see âSMIâ code list in Appendix). (RQ2)
The presence of mental health comorbidities (depression, anxiety, eating disorders, personality disorders, learning disability) will also be determined using Read and SNOMED codes (see example âDepressionâ code list in Appendix (Please note we were unable to amend the Appendix section at this time, but can forward these lists on request)) (secondary outcome). (RQ2)
SMI duration will be determined using the date the primary SMI diagnosis was first recorded in primary care records (secondary outcome). (RQ2)
Physical long-term conditions and health behaviours (smoking status, body mass index, alcohol misuse, substance misuse) will be determine using Read and SNOMED codes (see example âLTCâ code list in appendix (Please note we were unable to amend the Appendix section at this time, but can forward these lists on request)). (RQ3)
Please note that CPRD will not be used to answer RQs 4 and 5.
Description: Lay Summary
There is evidence that people with severe mental illness (SMI) have a higher chance of dying from infection than people without SMI. However, very little is known about what types of infection drive this risk. We also donât know much about how and why risk of death from infection is increased in SMI. This project will use largescale electronic health records (CPRD) to help understand infectious disease mortality in people with SMI. Moreover, it will also try to understand why this risk is increased by looking at the following factors:
(i) Physical health â are there certain combinations of physical conditions (e.g., diabetes, heart disease) and health behaviours (e.g. smoking) which increase risk of death from infection in people with SMI?
(ii) How do sociodemographic factors (e.g., age, gender, ethnicity), socioeconomic factors (e.g. neighbourhood deprivation), and indicators of barriers to healthcare often experienced by people with SMI interact to increase risk of death from infection?
(iii) Does the use of antipsychotic medication affect infection mortality rates in SMI?Answering these questions will help guide the development and implementation of effective interventions, will inform health policy, and will improve the delivery of health services. Together, this will contribute to a reduction in premature death from infection in people with SMI.
Technical SummaryResearch questions (RQs)
1. Does SMI selectively increase mortality risk for specific infection types?
2. What SMI-related factors associate most strongly with infectious disease mortality?
3. Do certain combinations of physical long-term conditions and health behaviours increase risk of death from infection in SMI?
4. To what extent do sociodemographic factors and indicators of barriers to healthcare affect infectious disease mortality in SMI?
5. How do antipsychotics affect infection mortality rates in SMI?We will carry out a retrospective matched cohort study where patients with SMI will be matched to patients without SMI at a ratio of 1:4 using propensity score matching. Patients will be matched on age, sex, primary care practice, and year of primary care practice registration.
The primary outcome of the study will be death from infectious disease. Linkage with Office of National Statistics (ONS) mortality data will provide date and cause of death. Linkage with Hospital Episode Statistics (HES) will allow us to include hospitalisations for infection as a secondary outcome.
We will use Cox proportional hazards regression to examine whether SMI increases mortality risk for specific infection types (RQ1), and to assess what SMI-related factors (e.g., diagnosis) associate most strongly with infectious deaths (RQ2).
We will adjust for covariates not used for control matching. These will include ethnicity, marital status, Index of Multiple Deprivation, smoking status, body mass index (BMI), alcohol and substance misuse, and number of physical long-term conditions (LTCs) (e.g., cancer, diabetes).
Using advanced statistical techniques (e.g., cluster analysis), we will ascertain whether certain combinations of LTCs and health behaviours (e.g., smoking) increase risk of death from infection among people with SMI (RQ3). We will use Cox regressions to estimate associations between these groups of LTCs and infectious disease mortality.
Please note CPRD will not be used to answer RQs 4 and 5.
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Patterns of multiple morbidity in people with Down syndrome compared to the general population and people with other intellectual disabilities: a cohort study — Asaad Baksh ...
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Patterns of multiple morbidity in people with Down syndrome compared to the general population and people with other intellectual disabilities: a cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-01
Organisations:
Asaad Baksh - Chief Investigator - King's College London (KCL)
Asaad Baksh - Corresponding Applicant - King's College London (KCL)
Andre Strydom - Collaborator - King's College London (KCL)
Li Chan - Collaborator - Queen Mary University of London
Martin Gulliford - Collaborator - King's College London (KCL)
Sarah Pape - Collaborator - King's College London (KCL)Outcomes:
The development of health conditions and combinations of conditions found to be important for the study of multiple morbidity (Ho et al., 2022) and those associated with people with DS, including; congenital heart disease; dementia; hypothyroidism; epilepsy; obstructive sleep apnoea (OSA); haematological malignancy; cancer (solid tumour); chronic respiratory disease; asthma; obesity; cataract; glaucoma; peripheral vascular disease; thrombosis; ischemic heart disease; stroke/cerebrovascular disease; diabetes (both type 1 and type 2); kidney disease; hypertension; hypercholesterolaemia; osteoporosis/osteopenia; inflammatory bowel disease; ear disorders; constipation; other endocrine disorders; systemic autoimmune conditions; peripheral autoimmune conditions; dental inflammation; sleep disorder not including OSA; liver disease; psychiatric conditions (e.g. depression, anxiety disorders, psychosis). We will also examine mortality rates.
Description: Lay Summary
People with Down syndrome have poorer health than people in the general population. As people with Down syndrome are living longer, we need to know what kind of health conditions they develop and at what ages, and if these differ between men and women to provide them with the right care at the right time.
We will use CPRD data to look at long-term health conditions (health conditions that need ongoing management over a number of years, e.g. obesity, diabetes) and multiple morbidity (having two or more health conditions) in people with Down syndrome and compare them to the general population and to people with other intellectual disabilities.
We will look at whether health conditions and death rates are different in men and women. We will use innovative methods to understand at what age multiple morbidity starts to increase and the order in which people with Down syndrome develop new health conditions, as it may differ from other people. We will then look at whether adults with Down syndrome can be grouped together based on their combination of health conditions.
By studying people with Down syndrome, we can help to make sure they receive better healthcare, while finding out new things about health conditions in the general population and people with other intellectual disabilities. This is important with the introduction of the new Down syndrome Act in April 2022 which states that the Government and the NHS should develop new guidance to improve the care for people with Down syndrome.
Technical SummaryThe Down syndrome (DS) phenotype is complex and impacts multiple bodily systems. People with DS are more likely to develop many long-term health conditions (health conditions that require ongoing management over a period of years, e.g. obesity, diabetes) and adults with DS are at a higher risk of multiple morbidity. To improve care and optimise the management of long-term conditions, healthcare guidance for clinicians needs to focus on potential sex differences and delivering the right care at the right time in accordance with the Down syndrome Act 2022.
Objectives:
We will include people with DS in the CPRD datasets (GOLD and Aurum) and linked data and examine the similarities and differences in multiple morbidity patterns by sex and compared to general population and people with other intellectual disabilities.
Methods:
We will select a cohort of individuals with DS from CPRD and linked data and conduct cross-sectional and longitudinal analyses in comparison with two sex, age and general practice matched control groups: individuals from the general population, and those who have other intellectual disabilities but not DS:
1. Use traditional multivariable models (Cox and Poisson regressions) to examine sex differences in the development of health conditions and potential differences in mortality.
2. Apply Emax modelling to examine the earliest age at which multiple morbidity start to increase and examine features of multiple morbidity by age-group.
3. Use Markov modelling methods to sequence the development of multiple morbidity over the lifespan.
4. Investigate whether health comorbidity data can be used to identify subgroups which are at higher risks of poor health outcomes using clustering analysis.These analyses will provide new insights into health conditions in DS and help to understand the unique health needs of people with DS to inform policies and improve equity of care.
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Repeat measures of anthropometry in patients with obesity to inform a model-based cost-effectiveness analysis for the treatment of obesity — Francesca Crowe ...
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Repeat measures of anthropometry in patients with obesity to inform a model-based cost-effectiveness analysis for the treatment of obesity
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-19
Organisations:
Francesca Crowe - Chief Investigator - University of Birmingham
Chidubem Okeke Ogwulu - Corresponding Applicant - University of Birmingham
David Moore - Collaborator - University of Birmingham
Emma Frew - Collaborator - University of Birmingham
James Hall - Collaborator - University of BirminghamOutcomes:
The outcomes to be measured from the CPRD data will be repeat measures of anthropometry including height, weight and body mass index (BMI).
The primary outcome of the model-based economic evaluation will be QALYs gained, expressed as cost per QALY for the intervention versus comparator, in terms of incremental cost-effectiveness ratios (ICERs). Other outcomes will include disaggregated costs, , life years gained and net monetary benefit.Description: Lay Summary
Treating obesity could improve the health and quality of life of people living with obesity and reduce the burden of obesity complications. Treating obesity also has economic benefits for the individual, the NHS, and the wider economy. Bariatric (weight loss) surgery remains the most effective obesity treatment leading to sustained long-term weight loss. Although recommended for eligible persons the number of surgeries performed in the UK is one of the lowest in Europe.
Technical Summary
Endoscopic treatments for obesity are weight loss procedures that are delivered without performing major surgery. Endoscopic treatments have been increasingly available worldwide but not in the UK. These treatments are cheaper than bariatric surgery, require shorter hospital stays, and do not require full anaesthesia, which makes them a potential alternative to bariatric surgery and could improve treatment seeking in the NHS.
Part of our wider project includes a comparison of endoscopic therapies to bariatric surgery and other weight loss interventions to know which of the alternatives provides the best value for money using an economic model. To help develop the model, we will use repeated measures of height, weight and body mass index in people with obesity recorded in primary care data. This data will be obtained from the Clinical Practice Research Datalink (CPRD) Aurum dataset.
The use of CPRD data is part of wider research that will inform clinical guidelines for endoscopic treatments for obesity. The findings will be disseminated to healthcare practitioners, patients and commissioners to enable them to make informed decisions regarding obesity treatmentsObesity negatively impacts health, the NHS and economy. Bariatric surgery (BS) is currently the most effective obesity treatment resulting in sustained long-term weight loss and improved quality-of-life. NICE, recommended BS as treatment options in patients who fulfil certain criteria. However, the number of BS performed in the UK is the lowest in Europe.
Endoscopic obesity treatments are increasingly available and are cheaper, with shorter hospital stays, and less anaesthesia, making them a potential alternative, to BS and could address some barriers to NHS treatment access.
Aim:
To establish the clinical and cost-effectiveness of endoscopic treatments using an evidence synthesis and economic model.Objectives:
-To develop a model that facilitates comparison of endoscopic treatment with BS and pharmacotherapy.
- To establish the cost-effectiveness of endoscopic treatment versus BS and pharmacotherapy.Study design
A model-based economic evaluation will be conducted from the UK-NHS perspective using data from evidence synthesis. To construct a meaningful model, it must as closely as possible, represent the people who might undergo endoscopic treatment. This need underpins this application. The primary purpose of this application is to access repeat anthropometric measurements in CPRD to inform parameters for the BMI distribution of the modelâs baseline population. The CPRD will not inform the use of BS or pharmacotherapy.Outcomes
The measures will include weight/height and BMI among patients who attended primary care units from 2017 to 2019 including adults aged â¥21 years, adolescents 12-21 years and children <12 years. The modelâs baseline BMI distribution will be derived from these repeat measures of height/weight/BMI.Impact
The findings will influence clinical guidelines and the commissioning of endoscopic treatments for obesity and overall reduce the complications of obesity. The project outputs will be disseminated to healthcare practitioners, patients and commissioners to enable them to make informed decisions regarding endoscopic treatments for obesity.
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PREdictors for DiabetIC Ketoacidosis at Diagnosis of Type 1 Diabetes (The PREDICT project) — Chintan Dave ...
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PREdictors for DiabetIC Ketoacidosis at Diagnosis of Type 1 Diabetes (The PREDICT project)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-05
Organisations:
Chintan Dave - Chief Investigator - Rutgers, The State University of New Jersey
Chintan Dave - Corresponding Applicant - Rutgers, The State University of New Jersey
Abner Nyandege - Collaborator - Rutgers, The State University of New Jersey
Brian Strom - Collaborator - Rutgers, The State University of New Jersey
Jason Roy - Collaborator - Rutgers, The State University of New Jersey
Sally Radovick - Collaborator - Rutgers Robert Wood Johnson Medical SchoolOutcomes:
Hospitalization due to Diabetic Ketoacidosis (DKA) (all aims); all-cause and diabetic specific mortality (Aim 1 only)
Description: Lay Summary
Diabetic Ketoacidosis (DKA) is an acute complication of type 1 diabetes (T1D), and is the leading cause of hospitalizations and mortality (i.e., death) among children and younger adults with T1D in the US, UK and worldwide. DKA is also the presenting symptom of patients newly diagnosed with T1D, comprising between 30% to 40% of new cases in the US and UK, and 15% to 67% of the cases worldwide. However, due to limitations of current data, it is currently unclear whether patients presenting with DKA at diagnosis of T1D differ from those without presenting in DKA. Our specific aims are:
Aim 1: To estimate 20-year trends in incidence of T1D with and without DKA at presentation and to compare mortality rates in the two groups after T1D diagnosis. We will estimate the proportion of patients who present with DKA at diagnosis over the 20-year period, and estimate the 1-,3-, and 5-year mortality rates in both groups.
Aim 2: To ascertain the risk-factors associated with DKA at diagnosis. Using longitudinal clinical data, we will elucidate the key clinical (e.g., gastroenteritis) and non-clinical (e.g., healthcare access, social deprivation) risk-factors associated with a DKA presentation
Aim 3: To create models that predict patients and subgroups at highest risk of DKA at diagnosis. We will develop and validate statistical models that will help detect subgroups of patients that are at highest risk of presenting with DKA at diagnosis.
Technical SummaryDiabetic Ketoacidosis (DKA) is an acute complication of type 1 diabetes (T1D), and is the leading cause of hospitalizations, morbidity and mortality among children and younger adults with T1D; it is also the presenting symptom of patients newly diagnosed with T1D, comprising between 30% to 40% of new cases in the US and UK. However, due to paucity of data, it is unclear whether patients presenting with DKA at diagnosis differ from those without DKA. We will use CPRD Gold and Aurum from 2000 to 2023 with linked information on hospitalizations, mortality, and social deprivation.
Aim 1: Among patients â¤21 years old newly diagnosed with T1D, we will describe the secular trends in incidence of DKA at diagnosis, as well as the short- and long-term mortality rates in the two groups after T1D diagnosis.
Aim 2: Among newly diagnosed T1D patients, we will create etiological models to elucidate the patient-level risk factors associated with the outcome of DKA at diagnosis. Multivariate modified Poisson regressions will be employed to directly model the adjusted relative risks associated with each risk factor of interest.
Aim 3: Among a cohort of patients who do not yet have T1D and using the risk-factors from Aim 2, we will create prognostic models to risk stratify patient subgroups according to their estimated probability of the outcome of DKA at diagnosis. We will use logistic regressions to model the outcome of DKA at diagnosis.
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Disease burden in primary hyperoxaluria: a cohort study — Anne Helene Olsen ...
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Disease burden in primary hyperoxaluria: a cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-05
Organisations:
Anne Helene Olsen - Chief Investigator - Novo Nordisk A/S
Anne Helene Olsen - Corresponding Applicant - Novo Nordisk A/S
Azzeddine Zemam - Collaborator - Novo Nordisk A/S
Kirstine Belling - Collaborator - Novo Nordisk A/SOutcomes:
Number of inpatient hospitalisations; number of outpatient visits; number of GP visits; first occurrence of dialysis; liver transplant; kidney transplant; all-cause mortality; eGFR lab values
Description: Lay Summary
Primary hyperoxaluria (PH) is a family of rare genetic liver disorders which can lead to complications such as kidney stones and chronic kidney disease.
This study will investigate the disease burden for people with PH. Patient characteristics will be described (age, sex, what illnesses they had and what medicines they were being prescribed), as well as the characteristics of the area of their UKGP practice e.g. how deprived or wealthy the area was. The study will also describe visits to the health care system, and disease progression over time.
The study will add knowledge about how this disease affects the patients, and how the disease develops over time.
Technical SummaryPrimary hyperoxaluria (PH) is a family of rare, life-threatening genetic liver disorders which can lead to complications such as kidney stones and chronic kidney disease. The disease burden associated with PH has not been well characterized and thus further evidence is warranted. The aim of this study is to describe the disease burden for patients with a diagnosis of PH.
The study design is a retrospective cohort study. The study population will include patients with a diagnosis of PH from CPRD Aurum. The index date is defined as the first date of diagnosis. Patients must be research standard (registered as âacceptableâ in the database) with at least one year of registration prior to their index date. Patients will be followed up until the minimum of (a) their transfer out date, (b) their CPRD derived death date (if applicable), and (c) the last collection date of their GP practice.
The study population will be compared to two comparator populations consisting of (a) patients with chronic kidney disease (CKD), and (b) a sample of patients without a PH diagnosis. The two comparator populations will be matched with the study population on age, gender, and multiple deprivation index.
Baseline characteristics at index date (age, sex, multiple deprivation index, disease history and prescribed drugs), and rates of health care resource utilisation (visits registered in HES and Aurum) will be presented for the study and the comparator populations. Rates for initiation of dialysis, liver and kidney transplants (HES), and mortality (ONS mortality data), as well as progression of eGFR (Aurum) will be presented for the study and CKD comparator populations.
Intended public health benefit:
The study will contribute with increased knowledge about the disease burden and disease progression for this patient group.
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Risk of elevated plasma triglyceride levels on macrovascular and microvascular disease outcomes — Handrean Soran ...
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Risk of elevated plasma triglyceride levels on macrovascular and microvascular disease outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-13
Organisations:
Handrean Soran - Chief Investigator - University of Manchester
Bilal Bashir - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Maryam Ferdousi - Collaborator - University of Manchester
Safwaan Adam - Collaborator - University of ManchesterOutcomes:
Primary outcomes:
1. Composite of fatal and non-fatal cardiovascular events (Angina, Myocardial Infarction (MI), coronary revascularisation, stroke, Transient Ischemic Attack (TIA), Peripheral Artery Disease (PAD), Peripheral artery revascularisation, cardiovascular death) in cohort 1 and 2.
2. Composite of end-stage microvascular complications (retinopathy, nephropathy, neuropathy) in cohort 3.
Blindness, Laser treatment, proliferative retinopathy will be surrogate markers for end-stage retinopathy
End stage renal failure, Dialysis, creation of AV fistula and renal transplant will be surrogate markers for end-stage nephropathy
Non-traumatic lower extremity amputation will be surrogate marker for end-stage neuropathy.
Secondary Outcomes:
1. In cohort 1 and 2:
a) Cardiovascular endpoint: A composite of angina, myocardial infarction and coronary revascularisation.
b) Cerebrovascular endpoint: A composite of Stroke and transient ischemic attack.
c) Peripheral vascular endpoing: A composite of peripheral artery disease and peripheral artery revascularisation.
d) cardiovascular death
e) All cause death
In Cohort 3:
a) End-stage retinopathy
b) End-stage nephropathy
c) End-stage neuropathy
3. In Cohort 1 and 2 â Comparison of composite of fatal and non-fatal cardiovascular events in patients with and without triglyceride lowering medication (fibrates, statins, omega 3 fatty acids)
4. In cohort 3 â Comparison of composite of end-stage microvascular complications (neuropathy, nephropathy and retinopathy) with and without triglyceride lowering medication (fibrates, statins, omega 3 fatty acids)Description: Lay Summary
Heart attacks, strokes and blood circulation problems are the main cause of death in the United Kingdom. Health care professionals usually measure amount of fat in the blood because they are linked to these problems. There are different types of fat in the blood. The main blood fat that is measured and treated is cholesterol. Despite reducing cholesterol to very low levels, there remains a risk of heart attacks and strokes. It is important to understand if reducing other types of blood fats will reduce a personâs risk of having heart attacks or strokes. In addition, previous studies have suggested that abnormal amounts of fat in blood is linked to damage to back of eyes, kidneys, and nerves (which are cable like structures to carry signals between brain and rest of body and help to feel sensations and pain).
Technical Summary
We are planning to use information collected in patientsâ electronic health records and death registers to understand:
i) How common raised levels of fats are in the general population.
ii) The link between levels of different types of fat and risk of heart attack and strokes.
iii) To confirm the relationship between elevated fat levels and damage to eyes, kidneys, and nerves by examining this in a much larger number of people compared to other studies.
The findings of this study may help us to find another treatment target to prevent complications of raised fat in blood.Hypertriglyceridemia is a residual cardiovascular risk factor, independently associated with atherosclerotic cardiovascular disease (ASCVD) and diabetic microvascular complications. Establishing the role of hypertriglyceridaemia in cardiovascular and microvascular complications is crucial with new drug developments.
This study aims to explore association of hypertriglyceridemia with cardiovascular disease and diabetes-related microvascular complications.
Data will be obtained from CPRD Aurum with linkage to hospital (Hospital Episodes Statistics), mortality (Office for National Statistics) and deprivation (Index of Multiple Deprivation) data.
The study populations will comprise of 3 cohorts.
1. Adults with prior ASCVD (Secondary prevention cohort)
2. Adults with no prior ASCVD but have diabetes mellitus and one or more other established CV risk factors (Primary prevention cohort)
3. All adults with diagnosis of diabetes mellitus (Diabetes cohort)
Cohorts will be defined using SNOMED CT (UK edition), Read Version 2, and local EMIS Web® software-specific codes between 1 January 2010 and 31 December 2022 (or latest available data) for cohort 1 and 2, and 1 January 2000 to 31st December 2022 (or latest available data) for cohort 3.
The primary outcomes will be a composite of fatal and non-fatal cardiovascular events in Cohort 1 and 2, and a composite of end-stage retinopathy, nephropathy and neuropathy in Cohort 3. The secondary outcomes will comprise several cardiovascular endpoints, cerebrovascular endpoints, peripheral vascular endpoints, cardiovascular, and all-cause mortality in cohort 1 and 2, indivisual end-stage microvascular endpoints (retinopathy, nephropathy, neuropathy) in cohort 3 and effect of triglyceride lowering drugs (statins, fibrates, omega 3 fatty acids) on composite of fatal and non fatal cardiovascular and composite of end-stage microvascular end points.
Kaplan-Meier plots will be used to estimate the observed cumulative incidence of each outcome. Cox Proportional Hazard models will be used to estimate hazard ratios for the risk of outcomes across triglyceride groups.
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Community benzodiazepine and z-drug hypnotic prescribing after critical illness and the risk of emergency hospital readmission and death: a retrospective cohort study using the United Kingdom Clinical Practice Research Datalink (CPRD) — Nazir Lone ...
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Community benzodiazepine and z-drug hypnotic prescribing after critical illness and the risk of emergency hospital readmission and death: a retrospective cohort study using the United Kingdom Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-07
Organisations:
Nazir Lone - Chief Investigator - University of Edinburgh
Elizabeth Mansi - Corresponding Applicant - University of Edinburgh
Bruce Guthrie - Collaborator - University of Edinburgh
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Hospitalisations or deaths from falls, fractures, motor vehicle accidents, and drug overdose; All-cause hospitalisation; All-cause mortality.
Description: Lay Summary
About 160,000 people survive critical illness in the UK each year and with advances in critical care, this number is expected to grow. Reportedly, over half of critical care survivors have anxiety, post-traumatic stress disorder (PTSD), and sleep disturbances within the first months after hospital discharge which is frequently associated with decreased quality of life. Anxiety and PTSD can contribute to problems with sleeping and vice versa. Whether prescribed anxiety medications or sleeping tablets such as benzodiazepines and âz-drugsâ (such as zopiclone, zolpidem) are safe in critical care survivors has not been previously researched.
This study will examine prescribing and safety of benzodiazepines and z-drugs in survivors of critical illness. Specifically:
1. We will examine factors associated with new benzodiazepine and z-drug prescribing after critical care hospitalisation.
2. We will investigate whether benzodiazepine and z-drug prescribing after hospital discharge in critical care survivors increases the chance of outcomes such as emergency hospital readmission and death.
3. We will factor in other medications prescribed at the same time that may be associated with such adverse outcomes (for example, opioids and other sedating medications) and assess if certain groups of patients (e.g., elderly) are at higher risk of adverse events with benzodiazepine and z-drugs.We will share our findings to ensure that prescribers are aware of the results to reduce harms associated with these medications, to enable safer prescribing.
Technical SummaryMental health issues and insomnia affect about one of every two critical care survivors within a year of hospital discharge. Such conditions contribute to increased morbidity and mortality in medically unwell patients. Few studies have shown that anxiolytics and hypnotics such as benzodiazepines and z-drugs are commonly prescribed after discharge in adult survivors of critical illness. However, these patients may be more vulnerable to known adverse outcomes such as falls, fractures, motor vehicle accidents, and death. The safety of these medications in this population has not been previously investigated.
Our retrospective cohort study aims to investigate community prescribing in survivors of critical illness to: 1) identify risk factors for incident primary care prescribing of benzodiazepines and z-drug hypnotics within 90 days of index hospital discharge; 2) estimate the risk of adverse outcomes such as emergency hospital readmissions and death in patients exposed to benzodiazepines or z-drugs compared to unexposed patients; and 3) conduct subgroup analyses to understand if subpopulations of critical illness survivors have heterogeneous risk of adverse outcomes (e.g., those with multimorbidity or those co-prescribed sedating medications). We will leverage CPRD Aurum linked to Hospital Episode Statistics Admitted Patient Care (HES APC) for adults with a critical care stay. Outcomes of subsequent hospitalisation and death including diagnosis codes will be extracted from HES APC and ONS death registration. Community prescribing data will be extracted from CPRD Aurum. The association between benzodiazepine and z-drugs and outcomes will be estimated using a stratified Cox regression model to calculate hazard ratios and 95% confidence intervals while accounting for confounders and competing risks.
We will publish and disseminate our findings to ensure we reach multiple audiences to enable the safest prescribing possible.
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Measuring Primary Care Resource Utilisation in England with Clinical Practice Research Datalink (CPRD) Aurum — Ruth Keogh ...
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Measuring Primary Care Resource Utilisation in England with Clinical Practice Research Datalink (CPRD) Aurum
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-19
Organisations:
Ruth Keogh - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Celina Ysabel Gacias - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jessie Oyinlola - Collaborator - CPRDOutcomes:
The following outcomes will be measured per patient:
⢠Annual consultation rate
⢠Average time between appointments
⢠Annual cost of prescribed treatmentsThe following outcomes will be measured per GP:
⢠Annual utilisation rate
⢠Volume of consultations by month and yearDescription: Lay Summary
Measuring primary health care resource utilisation (HCRU) by patients is critical for assessing health system performance. It can provide comprehensive insights on the efficiency and effectiveness of resource allocation and equity of health care service delivery, whether it be studied on the level of the health system, a patient subpopulation, or on the basis of a particular disease.
The Clinical Practice Research Datalink (CPRD) Aurum system, established in 2018, collects health information from 1,491 GP practices that are using the EMIS Web® electronic health record software. As of the systemâs latest build in May 2022, it contains research-acceptable data on more than 13 million patients in England. Given its volume, it is a critical source of information for health systems research on primary HCRU.
This study aims to assess the availability and validity of data within CPRD Aurum for the measurement of HCRU, as determined through the frequency and cost of primary care consultations. Descriptive analyses will be done to investigate broad patterns in primary HCRU across patient demographics and regions of England as represented in CPRD Aurum. The validity of these measurements shall be established through assessments of data completeness and comparisons of summary statistics with the more mature CPRD GOLD system.
The study aims to inform the public health research community on the availability and validity of data within CPRD Aurum for conducting research on primary HCRU. Additionally, the exploratory analyses will improve current understanding of patterns in the frequency and cost of GP consultations across England.
Technical SummaryThe utilisation of primary health services is known to vary across a range of factors, such as patient demographics, clinical characteristics, and socioeconomic determinants of health. Understanding the extent of these variations is important to studies that aim to determine whether there are inequities in health care access across the health system or among patient subpopulations.
Given its growing coverage of registered patients, the CPRD Aurum system is a critical source of information for research on primary health care resource utilisation (HCRU). This retrospective cohort study aims to inform the public health research on the data within CPRD Aurum that can be used for deriving meaningful measurements of HCRU by providing a comprehensive assessment of the completeness and validity of relevant data elements within CPRD Aurum, and to provide a summary of the current trends in utilisation among the patients database from 2018 to 2022.
First, we shall evaluate the quality of the data elements within CPRD Aurum that can be used to measure the frequency and cost of GP consultations, then evaluate the quality of these fields based on the proportion of entries with complete and plausible entries. Second, descriptive analysis shall be conducted of summary statistics on GP consultations, to be measured across the study sample then stratified according to demographics and region of GP practice. The Index of Multiple Deprivation (IMD) will be used to factor in socioeconomic status as an additional covariate. Regression models will be used to describe associations between patient characteristics and utilisation. Third, both the data completeness assessments and summary statistics shall be compared with similar results using CPRD GOLD in order to determine whether there are significant disparities between the two data sources in terms of quality and coverage.
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Use of leukotriene receptor antagonists (LTRAs) among patients with asthma in the UK primary care: a drug utilisation study — Wallis Lau ...
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Use of leukotriene receptor antagonists (LTRAs) among patients with asthma in the UK primary care: a drug utilisation study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-13
Organisations:
Wallis Lau - Chief Investigator - University College London ( UCL )
Boqing Chen - Corresponding Applicant - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
1. The annual prevalence and incidence of LTRAs prescribing
2. The duration of LTRAs usage
3. The asthma control medications prescribed within one year before LTRAs initiation
4. The annual incidence of progressing from ICS alone to ICS+LTRA or ICS+LABA
5. The annual incidence of stepping up to the subsequent stage of therapy among patients on ICS+LTRA and ICS+LABA
6. The changes in the LTRAs prescribing before and after the drug safety warningsDescription: Lay Summary
Asthma is one of the most common respiratory disorders in the UK. Leukotriene receptor antagonists (LTRAs) are a class of maintenance medications used in patients with mild to moderate chronic asthma. Although LTRAs have been on the market for two decades, little is known about the pattern of usage over time in the UK. Of note, there are two national guidelines on asthma in the UK: the British Thoracic Society/Scottish Intercollegiate Guideline Network (BTS/SIGN) guideline and the National Institute for Health and Care Excellence (NICE) guideline. However, the timing of introducing LTRAs is different between guidelines, and how they may have affected the utilization patterns of LTRAs is unclear.
Montelukast, the most widely used LTRA in the UK, has been associated with side effects that affect mental health and brain function. The United States Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued 3 warnings about the association and alerted healthcare professionals. Given the serious side effects including suicide, it is important to evaluate the impact of the warnings on the real-world practice of LTRAs prescribing.
Therefore, the purpose of this study is to understand the utilization patterns of LTRAs in the UK primary care and to evaluate any impact of the different treatment guidelines and drug safety warnings on LTRAs prescribing. This study will help to inform future studies of safety and effectiveness of medications in asthmatic patients.
Technical SummaryLeukotriene receptor antagonists (LTRAs) are a class of maintenance medications used in patients with mild to moderate asthma and are prescribed primarily as adjunct therapy to inhaled corticosteroids (ICS). Although LTRAs have been on the market for two decades, little is known about the pattern of usage over time in the UK. In addition, there are factors that may impact on the utilization patterns of LTRAs.
First, there are two national guidelines on asthma in the UK: the British Thoracic Society/Scottish Intercollegiate Guideline Network (BTS/SIGN) guideline and the National Institute for Health and Care Excellence (NICE) guideline. One of the main differences between the two guidelines is the choice between introducing either LTRAs or long-acting beta2-agonist (LABA) after ICS. Second, the FDA and the MHRA have issued 3 drug safety warnings on the neuropsychiatric events of LTRAs.
Given these factors, this study will use data from January 2005 to December 2022 from CPRD linked to HES and ONS to describe the utilization patterns of LTRAs and to investigate whether the patterns have changed according to the treatment guidelines and safety warnings.
We will estimate the annual prevalence and incidence of LTRAs and the duration of LTRAs usage. To examine whether the LTRAs were initiated in accordance with the guidelines, we will assess the asthma control medications prescribed within one year before LTRAs initiation. We will also estimate the annual incidence of progression from ICS alone to 1) ICS+LTRA (NICE) and 2) ICS+LABA (BTS/SIGN), respectively; and the annual incidence of stepping up to the subsequent stage of therapy among patients on ICS+LTRA and ICS+LABA, respectively. Finally, the impact of the drug safety warnings on LTRAs prescribing will be evaluated using interrupted time series (ITS) analysis. This study will provide insight on the utilization patterns of LTRAs in the UK.
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Inadequate achievement in haemoglobin A1c and weight targets in adults with type 2 diabetes on once weekly glucagon-like peptide-1 receptor agonists therapy: a multi-variate analysis of UK primary care data — Katrien Wijndaele ...
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Inadequate achievement in haemoglobin A1c and weight targets in adults with type 2 diabetes on once weekly glucagon-like peptide-1 receptor agonists therapy: a multi-variate analysis of UK primary care data
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-06-19
Organisations:
Katrien Wijndaele - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Monica Seif - Corresponding Applicant - Adelphi Real World
Antje Hottgenroth - Collaborator - Lilly Deutschland GmbH
Antonia Geneidat - Collaborator - Adelphi Real World
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Kamlesh Khunti - Collaborator - University of Leicester
Kunal Gulati - Collaborator - Eli Lilly & Co - UK
Lill-Brith von Arx - Collaborator - Eli Lilly & Co - UK
Ramota Alaran - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Thomas Jennison - Collaborator - Adelphi Real WorldOutcomes:
HbA1c target attainment (<7.0%, <7.5%); Weight reduction (>0%, â¥5%, â¥10%, â¥15%); Composite HbA1c (>1%) and weight (>0%, â¥5%, â¥10%, â¥15%) reduction measure; Once weekly injectable GLP-1 RA continuation despite HbA1c reduction <1%; sociodemographic, clinical and treatment characteristics.
Description: Lay Summary
Type 2 diabetes (T2D) is a common condition, characterised by high blood glucose levels and associated with long-term complications and significant health, social and economic burden.
Lowering blood glucose levels is an important target, as it has been shown to prevent complications in patients with T2D such as kidney events and heart attacks. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are an established type of treatment which have been shown to reduce blood glucose levels with the added benefit of weight loss, while some such treatments also improve heart health by reducing the risk of heart attacks and strokes.Currently, there are three GLP-1 RA treatments taken as a once weekly injection approved for use in the UK for the treatment of T2D; dulaglutide, semaglutide and exenatide. UK guidelines for the treatment of T2D set a target for blood glucose levels of <7% after 6 months of using a once weekly injectable GLP-1 RA treatment. International reports have also set weight loss targets of 5-15% to indicate a slowdown in the progression of the condition.
Technical Summary
Little research has been carried out in the UK to understand if patients are achieving these set targets. Therefore, this study aims to address these gaps by describing the number of patients with T2D newly prescribed once weekly injectable GLP-1 RA treatment who achieve the blood glucose level and weight loss targets, and to assess the relationship between these reductions and patient demographic, health and treatment characteristics.Aim: To evaluate HbA1c target attainment and weight reduction after 6 months of once weekly injectable GLP-1 RA use in UK primary care clinical practice, and associated sociodemographic, clinical and treatment characteristics. This evidence will support physicians in making informed decisions regarding GLP-1 RA therapy to ultimately improve patientsâ outcomes and quality of life.
Objectives: To describe, after 6 months of once weekly injectable GLP-1 RA therapy use, the proportion of patients i) achieving a HbA1c of <7%, ii) achieving weight loss of >0%, â¥5%, â¥10% or â¥15%, iii) achieving â¥1% HbA1c reduction and weight reduction of >0%, â¥5%, â¥10% or â¥15%, and iv) continuing GLP-1 RA therapy despite failing to achieve a â¥1% HbA1c reduction. We will also describe sociodemographic, clinical and treatments factors associated with target attainment/ reductions, as well as longer-term (12 and 18 months) HbA1c target attainment and weight reduction.
Exposures: T2D diagnostic code; once weekly injectable GLP-1 RA therapy
Outcomes: HbA1c targets; weight reduction, composite HbA1c and weight reduction; GLP-1 RA continuation despite HbA1c reduction <1%; sociodemographic, clinical and treatment characteristics
Methods: A retrospective cohort study of patients with T2D newly initiating once weekly injectable GLP-1 RA therapy between Jan-2020 and Nov-2021 (indexing period), using primary care data (CPRD Aurum). The first/earliest treatment prescription date of once weekly dulaglutide, subcutaneous semaglutide or exenatide within the indexing period will determine the index date. A minimum of 12 months pre-index and 6 months of follow-up (continuous index GLP-1 RA therapy use) are required for study inclusion. Patients prescribed any GLP-1 RAs up to 3 months prior to their index date will be excluded.
Data analysis: Analysis will be descriptive in nature. Relative frequencies and proportions/percentages will be reported for categorical variables. Count, mean, median, standard deviation, interquartile range, and minimum/maximum values will be reported for numeric variables.
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ID-351: Know Diabetes Service evaluation — NHS Greater Glasgow and Clyde/ MyWay Digital Health...
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ID-351: Know Diabetes Service evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-23
Opt Outs: no information provided./p>
Organisations: NHS Greater Glasgow and Clyde/ MyWay Digital Health
Description: Diabetes.
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ID-349: Extension: LOng COvid Multidisciplinary consortium: Optimising Treatments and servIces across the NHS (LOCOMOTION) — Imperial College London...
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ID-349: Extension: LOng COvid Multidisciplinary consortium: Optimising Treatments and servIces across the NHS (LOCOMOTION)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Covid-19. Commercial
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ID-350: The impacts of air quality on preschool wheeze, asthma, and ADHD in children and young people in North West London — Imperial College London...
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ID-350: The impacts of air quality on preschool wheeze, asthma, and ADHD in children and young people in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Pediatrics. Commercial
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ID-352: North West London Integrated Care Board (ICB) Research And Innovation Project. — Imperial College Health Partners...
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ID-352: North West London Integrated Care Board (ICB) Research And Innovation Project.
Legal basis:Research and Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Multimorbidity, acute care, and mental health.
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ID-353: NHS data improvement for babies, children, and young people health services — NHS Royal Free London NHS Foundation Trust...
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ID-353: NHS data improvement for babies, children, and young people health services
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-23
Opt Outs: no information provided./p>
Organisations: NHS Royal Free London NHS Foundation Trust
Description: Pediatrics.
Source
2023 - 05
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Determining causes of death related to epilepsy: A feasibility study — Katherine Donegan ...
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Determining causes of death related to epilepsy: A feasibility study
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-23
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRA
Helen Booth - Collaborator - CPRD
Sophie Scanlon - Collaborator - MHRAOutcomes:
Death related to epilepsy; death related to epilepsy due to status epilepticus, an accident, suicide, SUDEP, or other
Description: Lay Summary
Every year in the UK, around 1,000 people die from causes related to epilepsy. These deaths can be due to Status epilepticus, when a seizure lasts too long; an accident, where the risk was increased due to a seizure; or suicide, of which epilepsy patients are at greater risk, amongst other causes. In some cases thereâs no clear reason why a patient with epilepsy has died. When this happens, itâs called sudden unexpected death in epilepsy (SUDEP). The biggest risk factor for SUDEP is having uncontrolled seizures. This can happen more frequently if a patient does not take epilepsy medications as they are advised, the medications they are taking are not fully effective in controlling their seizures, and/or around when a patient is switching from one medication to another. Accurately determining the cause of death in patients with epilepsy is important if you wish to monitor the health of epileptic patients particularly in relation to the use of antiepileptic medications. The purpose of this analysis is to explore how causes of deaths related to epilepsy are recorded by the GP and in death registration data to inform potential analyses within a national antiepileptics registry. The registry is helping to benefit the health of patients in England by enabling the monitoring of the use of antiepileptics in relation to measures introduced to ensure their safe use in women of child bearing potential.
Technical SummarySudden unexpected death in epilepsy (SUDEP) is defined as death in a patient with epilepsy that is not due to trauma, drowning, status epilepticus, or other known causes but for which there is often evidence of an associated seizure. As SUDEP is often unwitnessed, diagnosis is typically made through a post-mortem. Cause of death data for individual patients is predominantly available through death registrations databases. However, in England these are currently coded using the International Classification of Diseases (ICD-10) hierarchy which does not have a specific code for SUDEP. Cause of death can also be recorded by a GP following notification of autopsy results. The Systematized Nomenclature of Medicine Clinical Terms (SNOMED) coding system, often used for this, does contain a specific code for SUDEP. The purpose of this analysis is to explore the coding of causes of death related to epilepsy in linked primary care and Office for National Statistics (ONS) death registrations data in order to inform potential analyses of SUDEP using death registrations data alone linked to the England Antiepileptics in Pregnancy Registry developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and National Health Service (NHS) Digital. Such analyses will help monitor the impact of changes in the use of antiepileptics over time, particularly valproate and topiramate which are targets for risk minimisation and inform future regulatory and public health policy. Patients with an epilepsy-related code recorded as a cause of death in either the primary care or ONS death registrations data will be included in the study. The patterns of causes of death recorded within the death registrations data will be cross tabulated with recorded causes of death in the primary care data with percentage used to describe the distribution of one in relation to the other.
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Mortality risk following lung cancer diagnosis in people with and without Type 2 Diabetes Mellitus — Jennifer Quint ...
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Mortality risk following lung cancer diagnosis in people with and without Type 2 Diabetes Mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-10
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Sarah Cook - Corresponding Applicant - Imperial College London
Bodini Dharmasekara - Collaborator - Imperial College London
Eseosa Igbinosa - Collaborator - Imperial College LondonOutcomes:
1. Mortality â all cause and cause specific
Description: Lay Summary
Diabetes is known to increase the risk of developing a number of cancers and is associated with poorer outcomes in several, including breast cancer and bowel cancer. Despite the fact that diabetes is common in people with lung cancer, affecting up to 20% of those with lung cancer, it remains unclear if having diabetes has an affect on how long people with lung cancer live after their diagnosis. Although this has been studied before the findings from different studies have not all shown the same thing which makes it hard to know how to recommend doctors manage people with both lung cancer and diabetes. In this study, we will explore whether people who have lung cancer and diabetes live for a shorter time than those with lung cancer without diabetes and see if we can find any specific factors about diabetes that may increase the probability of dying such as how well diabetes is managed.
Technical SummaryType 2 diabetes mellitus (T2DM) and cancer are significant health burdens that contribute to high morbidity and mortality globally. In the UK, DM affects a substantial proportion of the population, with over 4.7 million people affected, while cancer accounts for over 160,000 deaths annually. Emerging evidence suggests there may be a link between Type 2 Diabetes mellitus (T2DM) and an increased risk of cancer, particularly breast, cholangiocarcinoma (both intrahepatic and extrahepatic), colorectal, endometrial, and gallbladder cancers. Although several epidemiological studies have suggested patients with DM may experience higher cancer-related mortality, establishing a causal relationship is challenging due to various shared risk factors, the most prominent being obesity. Studies exploring the relationship between DM and lung cancer have had conflicting results. Our aim is to determine if people with T2DM are at increased risk of death following lung cancer diagnosis than people without DM. If they are, we will then explore if certain factors are associated with increased risk of death e.g. DM control. We will use linked CPRD Aurum with HES APC, ONS data as well as IMD data. The ONS data will be used to determine our study outcome (death). HES APC data will be used alongside primary care data for diabetes complication e.g. dialysis, peripheral vascular disease. Our primary endpoint is all cause mortality but we will also explore cause specific mortality. We will use Cox Proportional Hazard models. This study will benefit patients by helping us to better understand risk of death following a lung cancer diagnosis in people with T2DM and if there are factors associated with that risk. This will guide future studies around possible interventions to reduce mortality.
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Investigating within-individual variation in depression when measured using common depression questionnaires — Tom Marshall ...
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Investigating within-individual variation in depression when measured using common depression questionnaires
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-10
Organisations:
Tom Marshall - Chief Investigator - University of Birmingham
Alex Gough - Corresponding Applicant - University of Birmingham
Alice Sitch - Collaborator - University of BirminghamOutcomes:
Within-individual variation of Hospital Anxiety and Depression Score (HADS); Becks Depression Inventory I and II (BDI) and Patient Health Questionnaire-9 (PHQ-9)
Description: Lay Summary
Doctors measure particular features of their patients, to diagnose conditions and to monitor progress of those conditions. Examples include laboratory tests, lung function measures, or questionnaires to assess pain, memory or depression. However, within the same patient, even if the patientâs condition has not changed, all measurements vary over time. This is partly due to chance. The variation is important, because chance variation in a measurement can lead to incorrect diagnosis or to incorrect judgement about the progress of the condition. Depression questionnaires are widely used to help diagnose and to monitor progress of depression. They are often used in people with other health conditions such as heart disease, to check if they may be suffering from depression. However there is almost no research on how scores from depression questionnaires vary within individuals. This means we may miss depression, overdiagnose depression, or incorrectly judge that a patient is either improving or getting worse.
Technical Summary
This study aims to investigate how much depression scores vary within individuals. We will investigate the data from individuals with more than one depression score and assess how much their scores vary. We will compare the variation in depression scores in people who have not been diagnosed with depression and those who have been diagnosed with depression. We will also investigate whether the variation differs in men and women, older and younger patients, those of different ethnicities and income groups.
Our results will help give practical guidance to doctors on how to use and interpret depression scores.Clinical measurements are undertaken to diagnose conditions, to monitor progress and to assess treatment effects. They include laboratory tests, clinical assessments and questionnaires.
Clinical measurements change when there are pathophysiological changes but even in the absence of pathophysiological change all measurements show within-individual variation. Some of this is due to cyclical factors but most is due to a combination of measurement error and chance variation in the parameter around a physiological homeostatic point. This is important, because chance variation can lead to incorrect diagnosis, incorrect judgement about progress or treatment effects. There is substantial research on within-individual variability of some measured parameters such as blood pressure.
Depression questionnaires (Hospital Anxiety and Depression Score, HADS; Becks Depression Inventory I and II, BDI; Patient Health Questionnaire-9, PHQ-9) are widely used for diagnosis and monitoring depression. There is little research on within-individual variation in depression scores and none on their variation in routine clinical practice. This means we have little understanding of the probability of misdiagnosis or of incorrect judgements about the effectiveness of treatment.
This study aims to quantify within-individual variation in commonly used depression scores (HADS, BDI, PHQ-9).
We will identify individuals with more than one measurement of a particular depression score. We will estimate the mean and the variance components as within and between-individual variance using a linear regression model. From this we calculate the within-individual coefficient of variation (CVi), as the square root of the variance divided by the mean. We will investigate how CVi differs between people with and without a diagnosis of depression or with or without drug treatment for depression, by sociodemographic characteristics and other patient characteristics such as chronic diseases, smoking, alcohol consumption, BMI and number of comorbidities.
Our results will help give practical guidance to doctors on the interpretation of depression scores.
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Direct oral anticoagulants and incidence of dementia in patients with nonvalvular atrial fibrillation. — Samy Suissa ...
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Direct oral anticoagulants and incidence of dementia in patients with nonvalvular atrial fibrillation.
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-22
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Corresponding Applicant - McGill University
Alvi Rahman - Collaborator - McGill University
Ekaterina Pazukhina - Collaborator - McGill University
Erica Moodie - Collaborator - McGill University
James Brophy - Collaborator - McGill University
Jean-François Boivin - Collaborator - McGill UniversityOutcomes:
The primary outcome of interest will be a composite of all forms of dementia, defined using relevant Read codes and SNOMED Clinical Terms (listed in appendix 2). Secondary outcomes will include different sub-types of dementia, including Alzheimerâs disease, vascular dementia, and non-otherwise specified/other dementias.
Description: Lay Summary
Atrial fibrillation (AF) is a common heart disease, characterized by irregular heart rhythm. People with AF are at increased risk of stroke. Furthermore, they face higher risk of developing dementia. People with AF are often prescribed drugs called anticoagulants for stroke prevention. There is also evidence that anticoagulants can decrease the risk of dementia in patients with AF. There are two types of anticoagulants: vitamin-K antagonists (VKAs) and direct oral anticoagulants (DOACs). DOACs are recommended over VKAs for stroke prevention because they have comparable efficacy and are easier to use. While there is evidence that DOACs are better at preventing dementia compared with VKAs, it is unclear whether there are differences between DOACs. Apixaban and rivaroxaban are the two most commonly prescribed DOACs. Thus, the main objective of our study is to assess whether one of these two DOACs - apixaban or rivaroxaban â provides more benefit in the prevention of dementia. We will form two groups of patients with AF, one group treated with apixaban and the other treated with rivaroxaban. We will compare the number of patients who are diagnosed with dementia during follow-up in those treated with apixaban with those treated with rivaroxaban. We will then study the benefit according to the duration of the oral anticoagulant treatment, and in different subgroups of patients. This study will provide important information to inform the choice of a particular DOAC in patients with AF.
Technical SummaryAtrial fibrillation (AF) is the most common cardiac dysrhythmia. Oral anticoagulation is essential in the management of AF to prevent stroke occurrence. It can also maintain cognitive functions by decreasing the frequency of silent strokes, microembolisms, or global cerebral hypoperfusion. Direct oral anticoagulants (DOACs) were shown to be at least as effective in preventing ischemic stroke or systemic embolism as warfarin, with a lower risk of major bleeding. There is also moderate evidence that DOACs as a class is associated with a decreased risk of dementia compared to warfarin. However, it remains unclear which DOACs have a higher protective effect against dementia.
We will conduct a population-based cohort study to assess the potential decreased risk of dementia associated with apixaban compared with rivaroxaban, the two most commonly used DOACs. We will assemble a cohort of all patients in the CPRD, aged 50 years or more, newly diagnosed with AF between 2011 and 2021 and initiating apixaban or rivaroxaban. Propensity score methods will be used to control for confounding. We will calculate incidence rates of dementia with 95% CIs for each exposure group, based on the Poisson distribution. Cox proportional hazards models will be fit to estimate weighted HRs and 95% CIs of dementia associated with apixaban compared with rivaroxaban. In secondary analyses, we will assess whether there is a duration-response relation and whether there is effect measure modification by age, sex, history of comorbidities, and whether the association varies by type of dementia. Several sensitivity analyses will be performed to assess the robustness of our results.
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Evaluation of risk prediction algorithms in CPRD Gold and Aurum — Julia Hippisley...
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Evaluation of risk prediction algorithms in CPRD Gold and Aurum
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-15
Organisations:
Julia Hippisley-Cox - Chief Investigator - University of Oxford
Julia Hippisley-Cox - Corresponding Applicant - University of Oxford
Carol Coupland - Collaborator - University of Nottingham
Diana Withrow - Collaborator - University of Oxford
Gary Collins - Collaborator - University of Oxford
Jennifer Hirst - Collaborator - University of OxfordOutcomes:
Risk of common diseases including cardiovascular disease, stroke, major haemorrhage, type 2 diabetes, cancer, thrombosis, kidney disease, osteoporotic fracture, COVID-19
Risk of emergency hospital admission
Risk of deathDescription: Lay Summary
The CPRD Gold and Aurum databases are large general practice databases which are widely used for research. They are similar to a third database called the QResearch database (www.qresearch.org) which is derived from 1500 practices using the EMIS clinical system However QResearch contain a different group of practices and are linked to different external data sources compared with the CPRD databases.
Our proposal is to test a range of prediction algorithms that have been developed on QResearch. Prediction algorithms work out the chances that a patient has got or might develop a disease in the future, based on information about them such as their age, sex, ethnicity and illnesses and treatments. This information can then be communicated to patients and used to help those who might need help to reduce their risk or referral to hospital for tests. We want to see how well these algorithms work on CPRD and to understand similarities and differences between the databases which will help us interpret the results.
Technical SummaryAims
Our primary aim is to evaluate a range of prediction algorithms that have been developed using the QResearch database. This includes validation of the performance of original and updated models for identifying individuals at high risk in terms of calibration, discrimination and decision curve analysis.
Our secondary aim is to quantify systematic differences between the three databases including geographical spread, diversity of the registered patient population, and clinical coding.
Study population of interest
Men and women aged 18 year + registered with practices
Primary outcomes : cardiovascular disease; stroke; type 2 diabetes; diabetes complications; osteoporotic fracture; emergency hospital admission; kidney disease; intracranial or upper gastrointestinal haemorrhage; death or hospitalisation from COVID-19; cancerData sources
GP data linked to HES, deprivation and mortality data
Study design
Open cohort design to undertake prediction modelling studies. This includes development using multivariable regression analysis, accounting for competing risks and validation studies assessing performance. Performance will be assessed using measures of calibration, discrimination (C-index, D statistic and R2), clinical utility (decision curve analysis) of a range of clinical risk algorithms for predicting outcomes.
We will use the linked data to assess completeness of recording of the primary outcomes of interest by examining the number of cases of each outcome recorded on the
(a) GP record alone
(b) GP record or deaths record
(c) GP or HES record
(d) GP or HES or death record
Intended public health benefit
Our study will develop and validate more accurate prediction models which can better estimate a patientâs risk of an adverse outcome taking account of their individual characteristics. This has several key benefits. For the individual patient, it can provide more personalised information on risk which can better inform discussions between clinicians and patients to help make decisions on treatment options.
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Comparative effectiveness of newer combination therapies in chronic obstructive pulmonary disease (COPD) — Samy Suissa ...
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Comparative effectiveness of newer combination therapies in chronic obstructive pulmonary disease (COPD)
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-24
Organisations:
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The primary outcome events are occurrence of the first moderate or severe exacerbation, occurrence of the first severe exacerbation defined by hospitalisation for COPD, and death from all-cause. The safety outcome is the occurrence of the first severe pneumonia defined by hospitalization for community-acquired pneumonia.
Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by increasing breathlessness. It is a major cause of disability, it reduces quality of life and is one of the leading causes of death. An acute exacerbation of COPD can occur when there is a sudden worsening of usual COPD symptoms such as increase wheezing and shortness of breath, as well as presence of persistent cough. Severe exacerbations require hospitalisation.
Technical Summary
Several treatments can be prescribed to improve COPD symptoms. Typically, it involves medication called bronchodilators. This class of drug helps to reduce shortness of breath by opening the airways and makes it easier to breath. However, the relief of symptoms often involves the addition of a different type of medicines such as the combination of one or two long-acting bronchodilators or with an inhaled corticosteroid. Recently, the combination of all three has been introduced. The objective of the study is to compare the effectiveness and safety of these different combinations in preventing exacerbations and mortality.
The findings of this study should provide useful evidence on the benefits and risks of these newer treatment in the context of real-world clinical practice and help inform clinical guidelines.The primary objective of this study is to compare the effectiveness and safety of chronic obstructive pulmonary disease (COPD) treatment with the single-inhaler combination of a long-acting muscarinic antagonist (LAMA), a long-acting beta2-agonist (LABA), and an inhaled corticosteroid (ICS; LAMA-LABA-ICS) with combinations of LABA-ICS and LAMA-LABA. The secondary objective is to compare combinations of LAMA-LABA with LABA-ICS and with LAMA monotherapy.
The source population will include all patients with a COPD diagnosis in 1995-2023, at least 40 years of age at diagnosis, who subsequently received these therapies after September 2013, when LAMA-LABA became available in the UK.. A cohort study will compare first-time users of a single-inhaler combination of LABA-ICS, of LAMA-LABA or LAMA-LABA-ICS after 15 September 2017, when triple inhalers were available, after adjusting by fine stratification weights using propensity scores to balance the confounders. Subjects will be followed for up to one year, until the occurrence of an exacerbation, moderate or severe, death , or hospitalization for community-acquired pneumonia. The weighted Cox proportional hazard model will be used to compare, as-treated, LAMA-LABA-ICS with LAMA-LABA and LABA-ICS on the risk of these outcomes, also stratified by blood eosinophil levels, prior exacerbations, and history of asthma.
The same techniques will be used to conduct a cohort study where first-time users of LABA-ICS, LAMA-LABA, or LAMA monotherapy, after 1 September 2013, will be compared on the same outcomes.
The tertiary objective is to compare the effectiveness and safety of fluticasone-based triple therapy with budesonide-based triple therapy on these outcomes.
Using the Aurum primary care data restricted to linkable HES-APC patients to identify severe exacerbation and hospitalized pneumonia, the findings of this study should provide useful evidence on the benefits and risks of these newer treatment in the context of real-world clinical practice and help inform clinical guidelines.
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Identifying coincident drugs that alter Parkinson's disease progression. — Zameel Cader ...
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Identifying coincident drugs that alter Parkinson's disease progression.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-24
Organisations:
Zameel Cader - Chief Investigator - Human Centric DD Ltd
Anthony Nash - Corresponding Applicant - Human Centric DD LtdOutcomes:
Primary Outcomes:
1. Rate of change of Parkinsonâs Disease (PD) treatment (L-Dopa equivalent daily dose: LEDD) after disease onset.
Secondary Outcomes:
1. Time from PD onset to a significant potential related sequelae (fall, delirium, infection, death) for all cases of PD or other forms of parkinsonism e.g., multiple system atrophy (MSA), progressive supranuclear palsy (PSP).
2. Clinico-demographic features and healthcare resource use in the Parkinsonian population.Description: Lay Summary
Parkinson's disease is a slowly emerging illness meaning that patients take several different drugs to manage their symptoms. Whilst some drugs, such as Levodopa, can control symptoms, no cures exist. Current therapies are also associated with significant side effects, including cognitive impairment (trouble remembering, learning new things, concentrating, or making decisions), somnolence (a state of drowsiness or strong desire to fall asleep) and dyskinesias (involuntary, erratic, writhing movements of the face, arms, legs or trunk). Hence there is a need to determine new ways of curing the disease. This study aims to determine if any non-Parkinson's disease drugs that the patient happens to be taking for other reasons have an unexpected positive impact on slowing the progression of Parkinson's disease. As CPRD Aurum does not directly measure Parkinson's disease progression, we will calculate a patient's Levodopa equivalent daily dose (LEDD) over time to measure disease progression and see if there are non-Parkinson's drugs that are associated with a slower rate of increase of LEDD.
Technical SummaryWe will examine non-PD drugs that have been prescribed to patients with PD for a non-PD reason to assess whether treatment is associated with a rate of change to the Levodopa equivalent daily dose (LEDD) and to assess any change in time from PD onset to a related clinical sequela. We will CPRD Aurum records for those patients with a PD diagnosis and PD prescription drugs. Records will be linked to A&E, admitted patient care and outpatient HES, and ONS death registration data. The population of interest comprises patients whose first medcodeid for PD or parkinsonism or a prodcodeid for an established PD symptomatic treatment is between 01/01/2000 and 31/12/2019. We will exclude those with a diagnosis code of Parkinsonâs Plus or malignant neoplasm of the brain. Several statistical modelling approaches will be used to calculate outcomes. For longitudinal analysis of LEDD, we will adopt a multilevel model with two levels, repeated measures (L1) over time nested within patients (L2). The LEDD rate of change is measured before and after the prescription of the non-PD drug. We will use an analysis of covariance to test for differences between groups. In addition, we will use Cox regression to model the time (after diagnosis) from non-PD drug exposure (index) to the first event of falling, infection, delirium, or dementia. The Log Rank test will compare the non-PD drug exposure group to a control group. Subject to a sensitivity analysis, we will use age and year at index, BMI, smoking and alcohol status, ethnicity, and comorbidity diagnosis as covariates. Several methods to control confounds will be adopted, including confounding-by-indication and biases like lead time bias and those associated with socioeconomic and patient demographics. Every effort has been made to control for confounds and biases; for ones we do not, we recognise as limitations.
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Health Inequalities and Impact of Faecal Immunochemical Testing (FIT) in Symptomatic Patients with suspected colorectal cancer (HIFITS) — David Humes ...
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Health Inequalities and Impact of Faecal Immunochemical Testing (FIT) in Symptomatic Patients with suspected colorectal cancer (HIFITS)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; CPRD Aurum Ethnicity Record
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-24
Organisations:
David Humes - Chief Investigator - University of Nottingham
Alastair Morton - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Joe West - Collaborator - University of NottinghamOutcomes:
Primary outcomes:
⢠Calculate the performance characteristics of FIT for diagnosing CRC and other significant bowel pathologies (Inflammatory Bowel Disease and colonic polyps);Secondary outcomes:
⢠Describe use of FIT in the UK, how this differs by region and patient demographics (such as age, sex, ethnicity and deprivation) and what impact these factors have on test performance for CRC and route to CRC diagnosis (defined as time from FIT test to definitive diagnosis, assessed across different FIT result categories);
⢠Calculate the effect medications (eg anticoagulants, antiplatelets and proton-pump inhibitors) have on the performance characteristics FIT for CRC;
⢠Explore the relationship between FIT result and CRC-related, cause-specific and all-cause mortality;
⢠Quantify the rates of extra-colonic cancers (those elsewhere in the gastrointestinal tract or elsewhere in the body) in patients having FIT, and whether FIT result impacts the probability of having an extra-colonic cancer.Description: Lay Summary
A test for blood in the poo, the Faecal Immunochemical Test (FIT), is accurate for finding patients at high risk of bowel cancer in screening. Recently, FIT has been used for patients with symptoms that may suggest bowel cancer, to improve diagnosis. FIT is recommended for patients with symptoms in England, but how itâs used, the effect on bowel cancer diagnosis and impact medications have on the result is unknown.
Objective:
⢠Assess how accurate FIT is for bowel cancer and other conditions in patients with symptoms.
⢠Investigate what differences in FIT use and accuracy exist by region, patient age, sex, ethnicity and deprivation, and how these impact route to diagnosis.
⢠Explore the impact that medications (such as blood-thinners) have on the accuracy of FIT.
⢠Evaluate links between FIT result and death, from bowel cancer or other causes.
⢠Describe what non-bowel cancers are found after FIT.Design: We will look at data routinely collected for patients who have undertaken a FIT for symptoms (2015-present). We estimate this will include approximately 260,000 patients, with no requirement for further patient input.
Outcomes and patient benefit: Exploring FIT usage is important to understand variations in the country. Calculating its accuracy will highlight for the first time its effectiveness in diagnosis of bowel cancer and other bowel conditions across the entire country in patients suspected of having cancer. Highlighting clinical benefits, as well as inequalities in access, will help adoption of this test in areas that would benefit the most.
Technical SummaryThe Faecal Immunochemical Test (FIT) is used for bowel cancer screening and increasingly for patients with symptoms of possible colorectal cancer (CRC). There are no national-level studies on inequalities in use and accuracy for CRC and other bowel conditions in symptomatic patients.
Objectives:
â¢Evaluate the performance characteristics of FIT for CRC, Inflammatory Bowel Disease and polyps.
â¢Describe inequalities in use of FIT for symptomatic patients across the UK, by sociodemographics (age, sex, ethnicity, deprivation), region, and how these impact test performance for CRC and time from test to CRC diagnosis.
â¢Quantify the impact medications (anticoagulants/antiplatelets/proton-pump inhibitors) have on FITâs performance for diagnosing CRC.
â¢Describe the relationship between FIT result and all-cause mortality.
â¢Quantify extra-colonic cancers diagnosed after FIT.Design:
Observational study using CPRD Aurum combined with HES for patients who have completed a FIT (excluding screening) 2015-present (estimated >260,000 patients). CRC diagnosis will be defined using a combination of CPRD, HES and ONS, with FIT result and sociodemographics from CPRD.
Performance characteristics at various thresholds will be calculated and Receiver-Operating Characteristic, Precision-recall and decision curves plotted to compare performance for CRC between regions, sociodemographic groups and medication usage. FIT usage will be compared to a baseline population of patients in each region, with differences in usage by sociodemographics assessed using Poisson regression. One/two-year mortality and extra-colonic malignancies will be compared between different FIT thresholds with logistic regression and time to death with Cox regression.Benefit:
This work is novel, will justify increasing usage of FIT and will highlight disadvantaged groups to target to increase healthcare equity.
Variations in performance by demographics/medication usage will inform risk-prediction in groups at higher risk from procedures, where different thresholds for investigation may improve risk-benefit balance, and association with all-cause mortality and extra-colonic cancers will inform decision-making for patients with raised FIT and no CRC.
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Describing Pulmonary Rehabilitation referral and uptake for patients with Chronic Obstructive Pulmonary Disease — Jennifer Quint ...
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Describing Pulmonary Rehabilitation referral and uptake for patients with Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-11
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Philip Stone - Corresponding Applicant - Imperial College LondonOutcomes:
Incidence and prevalence year on year of COPD 2009-2019; In each year, proportion of people eligible for, referred for or who declined, or completed PR; Regression coefficients for referral, uptake, and completion of PR by stratifying variable (age, gender, deprivation, ethnicity, region)
Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a common lung condition most often caused by smoking. COPD patients are at risk of episodes of severe deterioration, which are called 'exacerbations'. Exacerbations are the second commonest cause of adult emergency medical hospital admission in the UK and are associated with a shortened life and decreased quality of life. There are several interventions that can help to improve quality of life for people with COPD and may help to reduce the occurrence of exacerbations and therefore reduce the amount of healthcare required and its associated costs. One of these interventions is called pulmonary rehabilitation. Pulmonary rehabilitation requires people with COPD to attend an exercise and education class once or twice a week over a 4 to 6 week period. While many studies have investigated the effect of pulmonary rehabilitation on individual patients, analyses of cost-effectiveness for the NHS as a whole are less common. Outputs from this study will be used to inform a tool developed in collaboration with NHS England that will help predict the geographical regions and type of people that will benefit most from prioritising pulmonary rehabilitation resources.
Technical SummaryChronic obstructive pulmonary disease (COPD) is a common lung condition most often caused by smoking. COPD patients are at risk of severe episodes of deterioration, termed 'exacerbations'. Exacerbations are the second commonest cause of adult emergency medical hospital admission in the UK and are associated with descresed life expectancy and decreased quality of life. There are several interventions that can help improve quality of life in people with COPD and may also help to reduce exacerbations and the healthcare utilisation and cost associated with them. One of these interventions is pulmonary rehabilitation. Using CPRD Aurum data linked with IMD and HES-APC, we will determine the proportion of the population who have COPD (incidence and prevalence) between 2009 and 2019, and the proportion of people who are eligible for, referred for or decline, commence, and complete pulmonary rehabilitation. We will explore demographics that may affect uptake and regression coefficients will be used in a model to inform an NHS England dashboard in development that will help areas to determine their capacity and referral targets going forward.
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The impact of multimorbidity during pregnancy on maternal and child health and developmental outcomes — Abiodun Adanikin ...
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The impact of multimorbidity during pregnancy on maternal and child health and developmental outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; CPRD Aurum Mother-Baby Link; CPRD Aurum Pregnancy Register; CPRD GOLD Mother-Baby Link; CPRD GOLD Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-24
Organisations:
Abiodun Adanikin - Chief Investigator - Coventry University
Abiodun Adanikin - Corresponding Applicant - Coventry University
Jennifer Gamble - Collaborator - Coventry UniversityOutcomes:
a. Trend and clustering of multimorbidity in childbearing women.
b. Adverse pregnancy outcomes i.e., the risk of miscarriage, stillbirth, preterm birth, operative delivery, congenital abnormality, APGAR score less than 7 at 5 minutes, and neonatal unit admission (up to 48 hours),
c. Maternal outcomes i.e., severe maternal morbidity, postpartum haemorrhage, puerperal sepsis, postnatal depression (up to one year after childbirth), risks of maternal hospital admissions, maternal death.
d. Infant outcomes i.e., congenital anomaly, infant death, incident child multimorbidity.Description: Lay Summary
Multiple long-term health conditions (multimorbidity) are commonly found in older populations. However, there is growing evidence to suggest that multimorbidity is increasingly occurring in younger people. Recent research estimated that one in five women of childbearing age becomes pregnant with multimorbidity. We do not fully understand the reasons for the change in trends, how multimorbidity accumulate over time in women of childbearing age, and the diseases that are commonly found together. Additionally, women with multimorbidity often use multiple medications, however, the effect on the baby is not known. In addition, we are uncertain whether based on race and ethnicity, some women with multimorbidity have better outcomes than others.
Technical Summary
To fill the knowledge gaps, we will link and analyse the CPRD Mother-Baby link, HES Admitted Patient Care, ONS Death Registration, and the Patient Level Index of Multiple Deprivation datasets between January 1, 2003, and December 31, 2022. We will examine the accumulation and trend of multiple long-term health conditions among them. We will explore whether there are differences in pregnancy outcomes (e.g., risk of stillbirth, preterm birth) because of the motherâs race, and the effect of multiple medications on infant health, growth, early childhood development, and school performance. Furthermore, we will investigate the impact of multimorbidity during pregnancy on subsequent maternal health and the risk of maternal death. Our findings will inform the design of interventions to lower multimorbidity, promote equality in health outcomes, and improve the health of mothers and newborns.This research sets out to investigate the trend and impacts of multimorbidity during pregnancy on maternal and child health outcomes, and the associated use of multiple medications (polypharmacy) on infant health. This will be a population-based cohort study using linked datasets â the CPRD primary care data, Hospital Episode Statistics [HES] admission, Patient Level Index of Multiple Deprivation, and the ONS Death Registration datasets, of all women with antenatal and childbirth records in the England between 1 January 2003 and 31 December 2022.
The main exposures are multimorbidity and polypharmacy during pregnancy. The primary outcomes of interest include adverse pregnancy outcomes (such as the risk of miscarriage, congenital anomaly, stillbirth, preterm birth, birth asphyxia, and neonatal admission), maternal health and wellbeing (such as the risk of hospitalisations, and maternal death) and early infant health, including the risk of infant death. Other outcomes of interest are clustering of morbidities, and incident child multimorbidity.
We will explore the extent to which the prevalence of multimorbidity reflects co-occurrence (i.e., discordant) or clustering (i.e., concordant, likely with a shared aetiology) of any two of long-term medical conditions by exploratory factor analysis with promax rotation and examine associated determinants using multivariable logistic regression. We will use modified Poisson regression to explore the impact of multimorbidity on adverse pregnancy outcomes. Cox proportional hazards regression will be used to determine the risk of incident child multimorbidity and the impact of multimorbidity on maternal health wellbeing in later life.
The research results will foster guideline development and integrated care pathways for multimorbid pregnant women and contribute to improving child health.
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An Investigation into Multimorbidity Prevalence and Association with Clinical outcomes and Treatment effectiveness in Myocardial Infarction (IMPACT-MI): a matched cohort study using linked primary and secondary care data — Marlous Hall ...
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An Investigation into Multimorbidity Prevalence and Association with Clinical outcomes and Treatment effectiveness in Myocardial Infarction (IMPACT-MI): a matched cohort study using linked primary and secondary care data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-23
Organisations:
Marlous Hall - Chief Investigator - University of Leeds
Jonathan Batty - Corresponding Applicant - University of Leeds
Charlotte Sturley - Collaborator - University of Leeds
Christopher Hayward - Collaborator - University of Leeds
Mohsin Masood - Collaborator - University of LeedsOutcomes:
The following outcomes will be reported by multimorbidity status (i.e. those with ⥠2 pre-existing long-term conditions at the time of MI, vs. those with < 2 pre-existing long-term conditions at the time of MI), for individuals that had an index MI during the study period (1st January 2000 onwards).
Primary outcome:
The cumulative incidence of all-cause mortality at one year of follow-up, ascertained using linked ONS Death Registry data.Secondary outcomes:
1) The cumulative incidence of long term, all-cause mortality during the entire period of available follow-up, to be ascertained using linked ONS Death Registration data.
2) The length of stay during the index hospital admission (measured in days), to be ascertained using HES Admitted Patient Care data).
3) The cumulative incidence of hospital admissions for any cause at one year post-MI and during the total follow-up period, to be ascertained using HES Admitted Patient Care data.
4) The number of primary care consultations for any cause at one year post-MI and during the total follow-up period (to be ascertained using CPRD Aurum data).
5) The cumulative incidence of diagnosis of specific disease outcomes relevant to the post-MI context (including recurrent MI, stroke, heart failure and major bleeding), to be ascertained using both CPRD Aurum and linked HES Admitted Patient Care data.
6) The proportion of patients with MI that receive each component of âguideline-recommendedâ MI treatment. This includes: in-hospital coronary angiography +/- percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) and the commencement of regular secondary preventative medication (i.e. a dual antiplatelet therapy, a β-blocker, an angiotensin converting enzyme inhibitor [ACEi] or angiotensin II receptor blocker [ARB] and a statin).In addition, a comparator group that did not have an MI during the study period will be identified using risk-set matching. In this comparator population, the primary outcome and selected secondary outcomes (1, 3, 4 and 5) will be reported by multimorbidity status, in order to evaluate the interaction of MI and multimorbidity compared with a matched non-MI, non-multimorbid group. This will enable us to quantify the excess risk associated with MI in both patients with and without multiple long-term conditions that did not have an MI.
The following exploratory (hypothesis-generating) outcomes will be reported for all individuals with MI, vs. all individuals in the risk-set matched, non-MI sample:
1) The proportion of individuals with multimorbidity (the prevalence of ⥠2 long-term health conditions) and complex multimorbidity (⥠3 chronic conditions affecting ⥠3 body systems) at study entry and during follow-up.
2) The median number of long-term conditions diagnosed at study entry and during follow-up. The prevalence of individual long-term conditions at the time of study entry and the incidence of new conditions during follow-up will also be reported.
3) The proportion of individuals belonging to a given multimorbidity phenotype at the time of study entry and during follow-up, as ascertained using an unsupervised machine learning approach.Description: Lay Summary
As we get older, we become more likely to develop multiple long-term health conditions, which is referred to as âmultimorbidityâ. As a result of people living for longer and general improvements in medical care, more people that have a heart attack (also known as a âmyocardial infarctionâ) will have multimorbidity. This is a problem because patients with heart attacks receive specialist care from expert heart clinicians that may not be best equipped to care for patients with multiple, non-heart-related conditions. In addition, heart attack treatments were developed in clinical trials for heart attack patients without other long-term health conditions, so we do not know how well they work for patients with different patterns of multimorbidity.
This study aims to use anonymous GP and hospital records to find out what effect multimorbidity has on heart attack treatments and outcomes. We hope to use this information to find ways to improve how patients with heart attacks and other long-term conditions are cared for. We will look at the number of patients that have multiple long-term conditions at the time of a heart attack and how this has changed over time, study combinations of conditions that may lead to worse outcomes, and evaluate the safety and effectiveness of heart attack treatment for people with multiple long term conditions. The results of this study will enable doctors to provide more tailored and effective medical care after a heart attack, taking into account the other long-term conditions a person has.
Technical SummaryAs a result of population ageing and general improvements in medical care, an increasing proportion of patients that have an acute myocardial infarction (MI) have multiple pre-existing long-term health conditions. This presents significant challenges. Firstly, post-MI care is delivered by highly specialised cardiology teams, which may not be equipped to manage patients with a greater burden of complex, multi-system disease. Secondly, there may exist a risk-treatment paradox: patients with multiple long-term conditions at greatest risk of post-MI adverse outcomes may be less likely to receive appropriate treatments, due to greater perceived risks of treatment-associated harm. Lastly, patients with multiple long-term conditions were excluded from many landmark trials of MI treatment, making the optimal treatment strategy uncertain.
We will perform a retrospective cohort study to evaluate the impact of multimorbidity (⥠2 long-term conditions) on post-MI clinical outcomes. Our primary outcome of 1-year all-cause mortality will be derived from linked ONS Death Registry data and assessed by multimorbidity status, using multivariable flexible parametric survival models. The study will include individuals in CPRD Aurum with an index MI from 1st January 2000 onwards. We will use linked Hospital Episode Statistics data to ensure robust ascertainment of MI hospitalisation. In addition, small area-based Index of Multiple Deprivation (IMD) data will be used to adjust for the confounding effect of socioeconomic deprivation. Secondary objectives include: (i) quantifying the prevalence and determinants of multimorbidity among patients presenting with MI (and in a similar group of patients, without MI), (ii) characterising specific patterns of multimorbidity for individuals with MI (and non-MI comparators), and (iii) evaluating the impact of multimorbidity on guideline-recommended MI treatment equity, safety and efficacy. We envisage the findings of this study will enable the delivery of more appropriate, person-centred care to people with MI and multiple long-term conditions; improving their long-term clinical outcomes.
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Evaluation of the feasibility of conducting a non-interventional post-authorisation safety study (NI-PASS) of outcomes associated with the use of tacrolimus before conception or during pregnancy using real-world data — Sophia Fleming ...
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Evaluation of the feasibility of conducting a non-interventional post-authorisation safety study (NI-PASS) of outcomes associated with the use of tacrolimus before conception or during pregnancy using real-world data
Datasets:GP data, CPRD Aurum Pregnancy Register; HES Admitted Patient Care; HES Outpatient; CPRD Aurum Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-15
Organisations:
Sophia Fleming - Chief Investigator - IQVIA Ltd ( UK )
Mariana Amaro - Corresponding Applicant - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Claudia Denye - Collaborator - IQVIA - UK
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Karine Marinier - Collaborator - IQVIA Operations France SAS
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )Outcomes:
Type of exposure within 6-weeks pre index date or during pregnancy (tacrolimus, alternative immunosuppressive therapies, or concomitant exposure); Timing of exposure (within 6 weeks pre index date, during first, second, or third trimesters of pregnancy); Transplant type
Description: Lay Summary
Tacrolimus and other immunosuppressive medications have been approved to prevent organ transplant rejection. However, there is limited data about the side effects and health outcomes of pregnant women who use this medication during their pregnancy. This feasibility study aims to understand whether the CPRD Aurum data source contains a large enough number of patients to conduct a full study investigating the health outcomes of pregnant females who have received the drug Tacrolimus or other immunosuppressants either during conception or throughout their pregnancy. The study will specifically investigate the following objectives:
Technical Summary
⢠The number of female patients captured in CPRD Aurum who received a transplant and took Tacrolimus or other immunosuppressive medication before conception or during pregnancy
⢠The type of transplant received by female patients prior to conception
⢠The time the female patients received Tacrolimus or other alternative immunosuppressants before conception or during pregnancy.
The results of this study will help inform whether CPRD is a suitable data source to complete a full study to investigate the safety and potential effects of taking Tacrolimus or other immunosuppressive therapies when pregnant or trying to get pregnant.This feasibility study aims to assess the potential of selected data sources in providing adequate sample size to conduct a potential safety study evaluating pregnancy outcomes after exposure to tacrolimus and alternative immunosuppressants. The objectives are as follows:
1. To estimate, in each of the data sources, the count of pregnancies in which the mother is a transplant recipient who had an exposure before conception or during pregnancy to Tacrolimus or alternative immunosuppressants
2. To describe the type of transplantation (renal, liver, heart, or other transplant) among the transplant recipient mothers of the pregnancies assessed in the previous objective3. To describe the timing of maternal exposure to tacrolimus or alternative immunosuppressants before conception and during pregnancy
This will be a non-interventional multi-country feasibility assessment using longitudinal secondary data from CPRD and sources in other countries to assess exposure to tacrolimus and alternative immunosuppressants before conception and during pregnancy among transplant recipients, considering both maternal and paternal exposure. With pregnancy as the unit of analysis, the results will be counts of pregnancies with maternal exposure to tacrolimus and alternative immunosuppressants, considering the inclusion and exclusion criteria. The index date for each pregnancy will be defined as the date of conception and will determine the start of the observation period for each individual report of pregnancy.
Eligible patients will be identified within the CPRD Aurum Pregnancy registry and data related to their organ transplantation extracted from the Hospital Episode Statistics inpatient and outpatient data as this is a hospital based procedure. Data regarding the patientâs exposure to tacrolimus or alternative immunosuppressants will also be identified within CPRD Aurum. This feasibility will inform the ability to run a full study which will help inform clinical practice guidelines on prescribing tacrolimus and alternative immunosuppressants to transplant patients during pregnancy.
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Epidemiology of hereditary spastic paraplegia in the United Kingdom — Krishnarajah Nirantharakumar ...
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Epidemiology of hereditary spastic paraplegia in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-22
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Siang Ing Lee - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Harini Jeyakumar - Collaborator - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of BirminghamOutcomes:
(1) Hereditary spastic paraplegia
(2) Mental illness such as depression, anxiety
(3) Urinary and faecal incontinence
(4) Chronic fatigue syndrome
(5) Falls and hospital admissions for falls
(6) Osteoarthritis
(7) Knee and / or hip replacement
(8) All-cause mortality
(9) Prescription of medications for spasticity (baclofen, benzodiazepine), pain (neuropathic agents), incontinence (oxybutynin), antidepressants
(10) Preceding diagnosis (HSP mimickers): Cerebral Palsy, Multiple Sclerosis, Ataxia, Arthritis, Herniated disc and Neuropathy.Description: Lay Summary
Hereditary spastic paraplegia is a group of rare inherited conditions that causes muscle weakness and stiffness in the lower legs. The faulty gene causes the long nerve in the spine to deteriorate. As the symptoms can mimic other conditions, hereditary spastic paraplegia is often misdiagnosed.
It is a progressive condition with no cure. People with the condition may have trouble walking and eventually may need to use walking aids. They may also take medications and do physiotherapy to relief the symptoms. People with this condition can also experience incontinence, fatigue and falls. They may also experience wear and tear in the joints and may need joint replacement operations. The reduced mobility can lead to social isolation and consequently higher risk of mental illness.
People with this condition have reported difficulties accessing specialist care centres. Local patient support groups provide much needed peer support but there may be inequality with access. To help inform the planning of health service provision, it is important to estimate how many people are living with this condition in the UK and whether this varies by sociodemographic factors (e.g. ethnicity, geographical locations). Information on associated symptoms and complications can inform patients of their prognosis. Information on common misdiagnosis and health care utilisation will help improve care provided to people with this condition.
Technical SummaryThis study aims to describe the epidemiology of hereditary spastic paraplegia in the UK using routine health records from general practices and hospitals, death registry and linked small area data (for sociodemographic data). The study objectives include: estimating the incidence and prevalence of hereditary spastic paraplegia and stratify this by sociodemographic factors; describing the burden of symptoms and associated complications; health care utilisation; explore common misdiagnosis; and explore the utility of primary and secondary care routine health records in studying hereditary spastic paraplegia.
The exposure is a diagnosis of hereditary spastic paraplegia. Outcomes will include all cause mortality, associated symptoms and complications (mental illness, incontinence, fatigue, falls and osteoarthritis), health care utilisation (hospital admission for falls, joint replacement therapy), and medication utilisation for symptom management (e.g. baclofen to manage spasticity).
Incidence and prevalence will be estimated using sequential cross sectional and cohort studies for years 2000 to 2022. Outcomes will be estimated with cox regression analysis with a matched cohort study design. Comparisons will be made between people with and without a diagnosis of hereditary spastic paraplegia, matched for age (+/- 1 year) and sex.
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Assessing utilization rate, patient characteristics, and clinical and economic benefits of Oral Nutritional Supplement (ONS) with beta-hydroxy-beta-methylbutyrate (HMB) for adults at-risk or malnourished — Sophia Fleming ...
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Assessing utilization rate, patient characteristics, and clinical and economic benefits of Oral Nutritional Supplement (ONS) with beta-hydroxy-beta-methylbutyrate (HMB) for adults at-risk or malnourished
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-23
Organisations:
Sophia Fleming - Chief Investigator - IQVIA Ltd ( UK )
Maedeh Yakhchi Beykloo - Corresponding Applicant - IQVIA Ltd ( UK )
Briana Coles - Collaborator - IQVIA Ltd ( UK )
GIANLUCA LUCREZI - Collaborator - IQVIA Solutions Italy S.r.l
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
Rachel Armstrong - Collaborator - IQVIA - UK
Tarana Mehdikhanova - Collaborator - IQVIA Ltd ( UK )
Xiaohui Sun - Collaborator - IQVIA Ltd ( UK )Outcomes:
Age at index date; gender; ethnicity; geographical region; smoking history; alcohol use; Body Mass Index (BMI); comorbidities of interest (stroke, depression, colorectal cancer, breast cancer, dementia, musculoskeletal disorders and menopause); Charlson Comorbidity Index (CCI); Index of Multiple Deprivation (IMD);
Utilisation rates of primary care visits (GP and nurse visits); utilisation rates of poly-medication prescriptions; utilisation rates of (re)hospital visits (inpatient and outpatient); length of elective inpatient admissions; length of non-elective inpatient admissions; utilisation rates of emergency department (A&E) visits; costs of primary care visits (GP and nurse visits); costs of (re)hospital visits (inpatient and outpatient); costs of emergency department (A&E) visits.
Following analysis Primary objective 3 and Secondary objective 1 have been updated to reflect that propensity adjusted difference in difference will be replaced with exact matched difference in difference.
4. To compare absolute and exact matched difference-in-differences associated with all-cause healthcare utilization (HCRU) in 0-3, 0-6, 0-12 months before compared to 0-3, 0-6, and 0-12 months after index event, among community-dwelling adults at malnutrition risk or malnourished in the following settings:
a. Primary care visits (GP and nurse visits)
b. Poly-medication prescriptions
c. (Re)Hospital visits
o Inpatient admissions (including length of stay)
o Outpatient visits
d. Emergency department (A&E) visits
For the following treatment groups:
⢠HP ONS with HMB vs HP ONS without HMB
⢠HP ONS with HMB vs standard ONS
⢠HP ONS with HMB vs no ONS
⢠Any ONS (HP ONS with HMB, HP ONS without HMB, standard ONS) vs no ONSSecondary objectives:
2. To estimate the absolute costs and exact matched difference-in-differences associated with all-cause HCRU in 0-3, 0-6, 0-12 months before compared to 0-3, 0-6, and 0-12 months after index event, among community-dwelling adults at malnutrition risk or malnourished in the following settings:
a. Primary care visits (GP and nurse visits)
b. (Re)Hospital visits
o Inpatient admissions
o Outpatient visits
c. Emergency department (A&E) visits
For the following treatment groups:
⢠HP ONS with HMB vs HP ONS without HMB
⢠HP ONS with HMB vs standard ONS
⢠HP ONS with HMB vs no ONS
⢠Any ONS (HP ONS with HMB, HP ONS without HMB, standard ONS) vs no ONSDescription: Lay Summary
Nutrition is an important factor for general health and poor nutritional status leads to impaired immune system, also increases the risk for loss of muscle and bone mass, in turn increases the risk for falls and fractures, ultimately lower the capacity for independent living. Malnutrition affects the older and sickest individuals living in the community most. Nutritional interventions such as oral nutritional supplements (ONS) have been found to be effective in addressing the needs of at-risk or malnourished adults by increasing energy, protein intakes and body weight and reducing hospital readmissions and healthcare costs in older adults, thereby reducing the clinical and economic burden. In addition to protein intake as one of the key factors for muscle protein synthesis to support muscle health, β-hydroxy-β-methylbutyrate (HMB) is another important nutrient promoting metabolic activity to counteract muscle loss for older adults and various diseases states.
Technical Summary
Given the limited evidence on the effects of HMB supplementation in community-dwelling adults, we aim to conduct a retrospective analysis of adults 18 years and older at-risk or malnourished and assess the utilisation rate and characteristics of individuals with and without various ONS interventions.
Therefore, the study aims to highlight that managing malnutrition could significantly reduce healthcare use, with a positive budget impact, in older malnourished patients in primary care. Nutrition care can also reduce visits to healthcare providers, lower the frequency of emergency department (ED) visits, and shorten the length of stay when hospitalisation is needed.This is a retrospective cohort study using primary care records (Clinical Practice Research Datalink ) linked with secondary care data (Hospital Episode Statistics) in England. Adults 18 years and older at-risk of malnutrition or malnourished will be included with the utilisation rate and characteristics of individuals that use 1) high protein (HP) oral nutritional supplements (ONS) with β-hydroxy-β-methylbutyrate (HMB), 2) use HP ONS without HMB, 3) use standard ONS and 4) those that donât use ONS. The study period will be from 1st January 2015 until the most recent linked data available.
The study includes analyses of the incidence of malnutrition or at risk of malnutrition, patientsâ demographics and clinical characteristics, healthcare resource use (HCRU) and associated costs over three intervals at 3, 6, 12 months before and after initial diagnosis of malnutrition or being at risk of malnutrition.
Patient demographics and clinical characteristics of interest will be assessed and reported on. Healthcare resource utilisation rates and costs of interest are primary care visits, poly-medication prescriptions, (re)hospital visits (inpatient and outpatient), length of elective inpatient admissions, length of non-elective inpatient admissions and emergency department visits. HCRU and associated costs will be calculated using NHS reference tariffs for secondary care events and GP consultation cost data for primary visits. For each of the three intervals, the propensity-adjusted average treatment effect (ATE) will be calculated. A multiple propensity score will be used to account for baseline differences between treatment groups. The ATE will be the difference-in-differences (DID) between each treatment of interest relative to HP ONS with HMB with statistically significant DIDs.
This study aims to highlight that managing malnutrition could benefit patients of malnutrition through improved health care outcomes reducing visits to healthcare providers, lower the frequency of emergency department visits, and shorten the length of stay when hospitalisation is needed.
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Prevalence of asthma patients eligible for asthma biologics in primary care: an UK cohort study — Chloe Bloom ...
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Prevalence of asthma patients eligible for asthma biologics in primary care: an UK cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2023-05-24
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Freda Yang - Corresponding Applicant - Imperial College LondonOutcomes:
Number of asthma patients eligible for any biologic, omalizumab, mepolizumab, benralizumab, reslizumab and dupilumab according to NICE criteria.
Number of asthma patients eligible for biologic according to NICE criteria but not referred to secondary care for respiratory review.
Number of asthma patients eligible for omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab and tezepelumab according to pivotal phase 3 clinical trial inclusion criteria ie drug licensing criteria.
Description: Lay Summary
People with poorly controlled asthma despite conventional treatments may benefit from novel therapies known as biologics. Biologics reduce the number of asthma attacks and need for steroid treatment. This will improve patientsâ quality of life and reduce side effects from steroids.
There are currently five asthma biologics available in the UK, but unfortunately patients need to be steroid dependent or have had at least 3 severe asthma attacks in one year to qualify for treatment. Clinical trials showed patients with fewer attacks and milder disease also benefit from treatment, but these patients do not have currently have access to biologics in the UK.
We will determine the current number of patients who qualify for biologics and whether they were appropriately referred for treatment. We will also estimate the potential increase in number of patients eligible for treatment in the future if criteria changed to include those with milder disease. We will calculate the cost savings from reduced hospital admissions and treatment of asthma attacks if criteria were changed.
This project will help policy makers understand how many patients currently qualify for biologic therapy but do not have access to treatment. Our estimation of potential increase in patient numbers and cost savings will help policy makers plan for asthma services over the next decade. We will highlight potential reasons for why patients currently eligible for biologics do not have access to treatment and the cost-effectiveness of giving access to biologics for those who have milder disease.
Technical SummaryThe overarching aim is to determine the prevalence of asthma patients eligible for (but often do not receive) life-changing asthma biologics. There are 3 main study objectives. First, we aim to identify the prevalence of biologic candidates by searching for all asthma patients who are eligible for omalizumab, mepolizumab, benralizumab, reslizumab and dupilumab according to current NICE criteria and determine potential causes for discrepancies, if any, in the number of patients eligible or receiving biologics. Second, we will determine the prevalence of potential future biologic candidates by searching for patients eligible for any of the five current biologics or tezepelumab according to licensing criteria. Then we will estimate the number of avoidable exacerbations and hospital admissions if biologic eligibility criteria were changed from current NICE to drug licensing criteria. Finally, we will assess the influence of age of asthma diagnosis and duration of disease on eligibility for biologic treatments.
This is a cohort study using CPRD Aurum with linked Hospital Episode Statistics (HES) admission and outpatient data. The majority of statistical analyses are descriptive. We will identify the prevalence of biologic candidates using (1) inhaled corticosteroid prescriptions (2) oral corticosteroids prescriptions and (3) blood eosinophil count or atopic status. We will use logistic regression to estimate the effect of demographics and clinical characteristics on referral to secondary care (where biologics are instigated). We will use simple cost analyses and assumptions to calculate the healthcare cost implications of not commencing biologics.
Our findings will enable policymakers to plan future healthcare services to deliver biologic treatments to patients who meet eligibility criteria now and in the future, to reach the right demographic of patients, identify and address the barriers to accessing treatment and estimate the potential cost-savings from amendments of current biologic prescribing guidance.
Source -
ID-339: National Evaluation of Group Consultation Models – Conditionally approved subject to correcting the relevant partner signatures
— Self...
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ID-339: National Evaluation of Group Consultation Models – Conditionally approved subject to correcting the relevant partner signatures
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Self-employed GP
Description: Group Consultations .
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ID-340: Support for patients on an Orthopaedic Waiting List
— Harrow Borough Based Partnership...
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ID-340: Support for patients on an Orthopaedic Waiting List
Legal basis:Cohort Recruitment
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Harrow Borough Based Partnership
Description: Orthopaedics .
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ID-346: Extension: Supporting early feasibility for non-commercial studies in North West London
— Imperial College Healthcare NHS Trust ...
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ID-346: Extension: Supporting early feasibility for non-commercial studies in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Feasibility Searches .
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ID-337: Cervical Cancer Campaign Impact — Westminster City Council...
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ID-337: Cervical Cancer Campaign Impact
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Cervical Cancer .
Source -
ID-341: Extension: Investigating integrated health care systems for children and young people (CYP)
— Department of Primary Care & Public Health...
see more
ID-341: Extension: Investigating integrated health care systems for children and young people (CYP)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Department of Primary Care & Public Health, Imperial College London
Description: Children and Young People .
Source -
ID-336: Exploring patterns of emergency healthcare utilisation in paediatric populations using a segmentation approach: a retrospective cohort study using routinely collected paediatric emergency department data and linked community healthcare datasets in North West London
— Harrow Council...
see more
ID-336: Exploring patterns of emergency healthcare utilisation in paediatric populations using a segmentation approach: a retrospective cohort study using routinely collected paediatric emergency department data and linked community healthcare datasets in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Harrow Council
Description: Pediatrics .
Source -
ID-343: Extension: The impact of COVID-19 on antibiotic prescribing in North West London
— Imperial College London...
see more
ID-343: Extension: The impact of COVID-19 on antibiotic prescribing in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Covid-19 .
Source -
ID-335: Extension: Quality of secondary prevention following percutaneous coronary interventions in North West London
— Royal Brompton & Harefield Hospitals NHS Trust...
see more
ID-335: Extension: Quality of secondary prevention following percutaneous coronary interventions in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Royal Brompton & Harefield Hospitals NHS Trust
Description: Coronary Disease .
Source -
ID-344: Extension: Care coordination for Adolescents in Crisis
— Imperial College London...
see more
ID-344: Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Pediatrics .
Source -
ID-342: Uncovering Patterns of Falls Risk Factors: A Cross-sectional Analysis of Integrated Electronic Health Records in North-West London
— Imperial College London...
see more
ID-342: Uncovering Patterns of Falls Risk Factors: A Cross-sectional Analysis of Integrated Electronic Health Records in North-West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Falls . Commercial
Source -
ID-338: A prospective linked data study on the potential benefit of using FARSITE to aid Atrial Fibrillation screening – Conditionally approved subject to providing the data flow
— Chelsea & Westminster Hospital NHS Foundation Trust...
see more
ID-338: A prospective linked data study on the potential benefit of using FARSITE to aid Atrial Fibrillation screening – Conditionally approved subject to providing the data flow
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Chelsea & Westminster Hospital NHS Foundation Trust
Description: Atrial Fibrillation .
Source -
ID-334: Extension: The Economic Impact of Pneumonia across Health and Social
Care Settings
— ICHP...
see more
ID-334: Extension: The Economic Impact of Pneumonia across Health and Social
Care SettingsLegal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Pneumonia . Commercial
Source -
ID-332: Extension: Mapping the clinical journey of patients with Chronic Kidney
Disease (CKD) in North West London (NWL)
— Imperial College Healthcare NHS Trust/Imperial College...
see more
ID-332: Extension: Mapping the clinical journey of patients with Chronic Kidney
Disease (CKD) in North West London (NWL)Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/Imperial College
LondonDescription: Kidney Disease . Commercial
Source -
ID-345: Extension: Flagging of the West London personality disorder patient data
into the WSIC data set and extraction of data on personality
disorder cohort in North West London — The Open University... see moreID-345: Extension: Flagging of the West London personality disorder patient data
into the WSIC data set and extraction of data on personality
disorder cohort in North West LondonLegal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: The Open University
Description: Personality Disorders .
Source -
ID-333: Extension: Characterizing and Preventing Multimorbidity in NW London
— Imperial College London...
see more
ID-333: Extension: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May -23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity .
Source
2023 - 04
-
Exploring the dynamics of the nursing and midwifery workforce — unknown...
see more
Exploring the dynamics of the nursing and midwifery workforce
Where: unstated
When: 2023-4-6
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This pilot project aims to understand change in the nursing and midwifery workforce. It explores the current profile of the nursing and midwifery workforce (who enters, stays, and leaves - and for how long), demographic and geographical influences on this profile, as well as any risk factors and their implications for the workforce and its future planning. This initiative is led by the Scottish Centre for Administrative Data Research (SCADR), part of ADR Scotland.
The Nursing and Midwifery Council (NMC) requires registrant data to be collected to enable their regulatory functions. This means that nurses and midwives must re-register every three years. The resulting data is a powerful overview of who is in (or leaves) the professions, which can inform policies to better support nurses and midwives.
This registrant data will be used to understand the current profile of the nursing and midwifery professions in the UK, and to understand their dynamics - especially which groups are likely to leave. Findings will be made available through reports and publications, with the intention of informing decision making that benefits nurses, midwives, and the wider public.
Administrative data undoubtedly provides a considerable resource for social research. As challenges from the Covid-19 pandemic persist, and as many novel challenges emerge, the potential of that data is becoming greater. The nursing and midwifery workforce is clearly key to the recovery of the health service. The work outlined here provides scope to support policymakers - whether in the Nursing and Midwifery Council, the health service, social care, or otherwise - in using administrative data to make decisions and develop approaches to ensure the future wellbeing of those in the nursing and midwifery professions across the UK.
Source -
ID-325: Extension: Harrow Health and Wellbeing Profile (JSNA) — Harrow Council...
see more
ID-325: Extension: Harrow Health and Wellbeing Profile (JSNA)
Legal basis:Research and Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Harrow Council
Description: JSNA.
Source -
ID-324: Extension: Polypharmacy — Imperial College London...
see more
ID-324: Extension: Polypharmacy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Polypharmacy.
Source -
ID-328: Deaths data matching – conditionally approved subject to providing updated amendments based on committee’s feedback — Westminster City Council...
see more
ID-328: Deaths data matching – conditionally approved subject to providing updated amendments based on committee’s feedback
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Mortality.
Source -
ID-322: Extension: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants. — Imperial College Health Partners...
see more
ID-322: Extension: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Alzheimer’s Disease. Commercial
Source -
ID-323: Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London. — Imperial College London...
see more
ID-323: Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimoribidity.
Source -
ID-329: Multiple Disadvantaged prevalence Westminster – conditionally approved subject to providing updated amendments based on committee’s feedback — Westminster City Council...
see more
ID-329: Multiple Disadvantaged prevalence Westminster – conditionally approved subject to providing updated amendments based on committee’s feedback
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Multiple Disadvantages.
Source -
ID-327: ICHP Feasibility Searches — Imperial College Health Partners...
see more
ID-327: ICHP Feasibility Searches
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Feasibility Searches.
Source -
ID-326: Impact of Covid-19 pandemic on preschool wheeze, salbutamol inhaler use and respiratory infections in children ≤3 years old in North West London — Department of Primary Care & Public Health...
see more
ID-326: Impact of Covid-19 pandemic on preschool wheeze, salbutamol inhaler use and respiratory infections in children ≤3 years old in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-23
Opt Outs: no information provided./p>
Organisations: Department of Primary Care & Public Health, Imperial College
London & Imperial College Healthcare NHS TrustDescription: Asthma.
Source
2023 - 03
-
Connecting administrative vehicle data for research on sustainable transport — unknown...
see more
Connecting administrative vehicle data for research on sustainable transport
Where: unstated
When: 2023-3-28
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Passenger cars and vans have a major influence on our environment, society, and health. In order to generate insights about these challenges, researchers need access to reliable information about vehicle details, usage and trends. This would enable them to build evidence to inform transport policy that benefits the public.
Data about vehicle attributes and location is currently collected by the Driver and Vehicle Licensing Agency (DVLA). Data from MOT tests, which check that a vehicle meets road safety and environmental standards, (and, importantly, are when vehicle mileages are recorded), is collected by the Driver and Vehicle Standards Agency (DVSA). However, it is currently impossible for anyone other than the data owners to link this information together. In addition, calculating annual vehicle mileages is computationally complex and requires significant investment of time and resources.
This project aims to link existing data sources to create de-identified datasets that researchers can use to understand vehicle ownership and usage patterns. These datasets will be updated annually and will cover all light-duty vehicles (under 3.5 tonnes) in Great Britain. They will contain information including data on vehicle type, mileage, emissions, and registered location (at Lower Layer Super Output Area level â a standard geographical unit for anonymously reporting Census statistics).
This new resource will have the potential to generate insights that inform sustainable transport policy design and implementation, at both the local and national level.
This project aims to work in partnership with the Department for Transport (DfT), DVLA, DVSA, Office for National Statistics (ONS), RAC Foundation, University of Bristol, and University of Leeds. The value of the data will be explored through partnership work with the Office for Zero Emission Vehicles; Zemo Partnership; the Energy and Security group in the Department for Business, Energy and Industrial Strategy; Road Safety Analysis Ltd and Agilysis Ltd, Transport for the South East, Transport for Greater Manchester and the British Vehicle Rental and Leasing Association.
Source -
ID-315: EXHALE 4&2 – Register – Conditionally approved subject to implementing committee members’ feedback — Imperial College Health Partners...
see more
ID-315: EXHALE 4&2 – Register – Conditionally approved subject to implementing committee members’ feedback
Legal basis:Cohort Recruitment
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Asthma. Commercial
Source -
ID-318: Extension: Estimating inequalities in burden of illness in patients with Alzheimer’s Disease — Lane Clark & Peacock LLP...
see more
ID-318: Extension: Estimating inequalities in burden of illness in patients with Alzheimer’s Disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Alzheimer’s Disease. Commercial
Source -
ID-313: Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity — Imperial College Health Partners...
see more
ID-313: Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Obesity. Commercial
Source -
ID-316: 12hr waits in Emergency Departments for Mental Health related attendances – WLT – Conditionally approved subject to implementing committee members’ feedback — NWL ICB...
see more
ID-316: 12hr waits in Emergency Departments for Mental Health related attendances – WLT – Conditionally approved subject to implementing committee members’ feedback
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-23
Opt Outs: no information provided./p>
Organisations: NWL ICB
Description: Mental Health.
Source
2023 - 02
-
Dynamics in private pension saving — unknown...
see more
Dynamics in private pension saving
Where: unstated
When: 2023-2-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project, led by the Institute for Fiscal Studies, will produce two new linked datasets on private pension saving that are high quality and accessible for approved research. The dataset will provide a comprehensive picture of how much money people in the UK are putting into personal pensions set against their employment type and total earnings. It will include employees as well as the self-employed, people working for their own companies and those not working.
How much money people save for their retirement is important. It matters not only for individualsâ wellbeing but also for society in general because those with insufficient private savings are more reliant on government benefits. This is increasingly important because people are living longer.
Various policy levers are used to encourage retirement saving. Most notably, there are large tax advantages to pension saving. In 2012, the government also began to roll out pension auto-enrolment. This policy requires employers to put most of their employees into a workplace pension scheme and contribute towards it. Despite these types of policy actions, there are concerns that some groups are not saving enough for their retirement.
The dataThe data will provide insights into private pensions in the UK by using comprehensive information on pension contributions (known as the COM100 data) held by HM Revenue & Customs (HMRC) from the 2007 to 2018 tax years. Specifically, the project will use de-identified data on total annual pension contributions made either by individuals or their employers to personal pensions and link this to individualsâ de-identified tax records. The tax records will also provide information on how much income a person has and how that income is generated.
The two linked datasets will be created by linking all the âCOM100â administrative data on annual contributions to personal pensions held by HMRC to:
Pay As You Earn (PAYE) panel tax records Self-Assessment panel tax records.The project team will produce documentation to support researchers in accessing the linked datasets, along with high-profile research to highlight its value.
Data for this project is being linked under the provisions of the 2017 Digital Economy Act, which provides a legal gateway for researchers to access government data in a secure way.
Potential of the newly linked dataResearch using this data has the potential to help us understand the patterns of pension saving across different groups in society and the role of various policies in shaping decisions. It could inform future government decisions on pensions policy, as well as related issues such as housing benefits and tax to improve the lives of older people and wider society.
Linking the de-identified HMRC data on annual pension contributions to the PAYE data will provide high-quality information on employees regarding their pay from their employers. It will also make it possible to observe details such as age and sex, which will allow us to understand differences in pension provision and savings for different parts of the work population. It will facilitate analysis of employee earnings and total personal pension contributions over a crucial period where there were significant changes to the saving environment, including substantial policy change.
The HMRC data linked to Self-Assessment tax records will yield high-quality data on personal pension saving and income for self-employed and high-income individuals. These groups are currently under-analysed due to data limitations. The self-employed have been the fastest growing part of the UK labour force since the early 2000s and around 15% of the UK workforce is now self-employed. This dataset will enable researchers to understand how pension contributions change as people move from employment to self-employment. It will also be possible to analyse whether the saving habits of people who were auto-enrolled as an employee influence their saving behaviour if and when they become self-employed.
In both linked datasets, it will be possible to track de-identified individuals over time, thereby observing, for example, how pension saving changes as income and the policy environment change. The analysis will also be able to indicate the effects of tax policy on different types of peopleâs behaviour, such as how much they save and their wider investment and economic choices.
Key questions these newly linked datasets could help to address include:
What are the factors that affect how people save for retirement? How has tax policy affected how much different types of people choose to save in a pension? How do pension contributions change as people move from employment to self-employment? AvailabilityIt is intended the private pensions linked datasets will be made available to external researchers via the Office for National Statistics Secure Research Service in late 2024 or 2025. This is subject to approval by the data owner HMRC. Accredited researchers will need to submit a successful application to access the data.
Early pathfinder researchIn addition to creating the linked datasets, the project team will undertake research on the linked datasets. The answers to two research questions will provide important insight into the patterns of saving for the retirement of workers in the UK:
How much are people saving in personal pensions and how does this change over working life? How does pension saving change when someone moves from being employed to self-employed and was this pattern changed by the introduction of auto-enrolment?This research will serve as an early pathfinder project to demonstrate the real-world value of the new or improved data linkage.
Project details Project lead: Helen Miller Co-Investigator: Dr Jonathan Cribb Other researchers include Carl Emmerson, Heidi Karjalainen, Isaac Delestre, Laurence OâBrien Funded value: £178,666.17 (full economic cost) Duration: October 2022 â December 2024This project is funded via the ADR UK research-ready data and access fund, a dedicated fund for commissioning research using newly linked administrative data. The funding decision was based on advice from an independent expert panel, and in consultation with the Office for National Statistics. This project is part of the ADR England portfolio.
Details of the funding grant awarded by ADR UK for this project can also be found on the UK Research and Innovation (UKRI) Gateway to Research platform.
Source -
Linked local data on children and young people — unknown...
see more
Linked local data on children and young people
Where: unstated
When: 2023-2-9
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
There are serious challenges facing social care, education and health services for children and young people in England. Beyond high profile cases of avoidable child deaths, the social costs of poor outcomes experienced by children in the care system are estimated to be £23 billion per year. From obesity to death rates, childrenâs health outcomes in England are worse than in many comparable European countries.
Across government, it is recognised that a joined-up strategy is necessary to tackle these challenges. New research is needed to understand the links between different sectors and identify the most effective interventions to improve childrenâs outcomes. While some research questions are best studied using national datasets, the additional breadth and depth of local datasets offer exciting new opportunities to study the impact of interventions and gain insights into the most effective strategies to improve outcomes.
In this project, the team aims to create a research-ready dataset linking data held on children by local authorities, including education and social care, with data held by health services. This new resource will enable researchers to build evidence to support local and national strategies that improve outcomes for children.
Source -
Dynamics in private pension saving — unknown...
see more
Dynamics in private pension saving
Where: unstated
When: 2023-2-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project, led by the Institute for Fiscal Studies, will produce two new linked datasets on private pension saving that are high quality and accessible for approved research. The dataset will provide a comprehensive picture of how much money people in the UK are putting into personal pensions set against their employment type and total earnings. It will include employees as well as the self-employed, people working for their own companies and those not working.
How much money people save for their retirement is important. It matters not only for individualsâ wellbeing but also for society in general because those with insufficient private savings are more reliant on government benefits. This is increasingly important because people are living longer.
Various policy levers are used to encourage retirement saving. Most notably, there are large tax advantages to pension saving. In 2012, the government also began to roll out pension auto-enrolment. This policy requires employers to put most of their employees into a workplace pension scheme and contribute towards it. Despite these types of policy actions, there are concerns that some groups are not saving enough for their retirement.
The dataThe data will provide insights into private pensions in the UK by using comprehensive information on pension contributions (known as the COM100 data) held by HM Revenue & Customs (HMRC) from the 2007 to 2018 tax years. Specifically, the project will use de-identified data on total annual pension contributions made either by individuals or their employers to personal pensions and link this to individualsâ de-identified tax records. The tax records will also provide information on how much income a person has and how that income is generated.
The two linked datasets will be created by linking all the âCOM100â administrative data on annual contributions to personal pensions held by HMRC to:
Pay As You Earn (PAYE) panel tax records Self-Assessment panel tax records.The project team will produce documentation to support researchers in accessing the linked datasets, along with high-profile research to highlight its value.
Data for this project is being linked under the provisions of the 2017 Digital Economy Act, which provides a legal gateway for researchers to access government data in a secure way.
Potential of the newly linked dataResearch using this data has the potential to help us understand the patterns of pension saving across different groups in society and the role of various policies in shaping decisions. It could inform future government decisions on pensions policy, as well as related issues such as housing benefits and tax to improve the lives of older people and wider society.
Linking the de-identified HMRC data on annual pension contributions to the PAYE data will provide high-quality information on employees regarding their pay from their employers. It will also make it possible to observe details such as age and sex, which will allow us to understand differences in pension provision and savings for different parts of the work population. It will facilitate analysis of employee earnings and total personal pension contributions over a crucial period where there were significant changes to the saving environment, including substantial policy change.
The HMRC data linked to Self-Assessment tax records will yield high-quality data on personal pension saving and income for self-employed and high-income individuals. These groups are currently under-analysed due to data limitations. The self-employed have been the fastest growing part of the UK labour force since the early 2000s and around 15% of the UK workforce is now self-employed. This dataset will enable researchers to understand how pension contributions change as people move from employment to self-employment. It will also be possible to analyse whether the saving habits of people who were auto-enrolled as an employee influence their saving behaviour if and when they become self-employed.
In both linked datasets, it will be possible to track de-identified individuals over time, thereby observing, for example, how pension saving changes as income and the policy environment change. The analysis will also be able to indicate the effects of tax policy on different types of peopleâs behaviour, such as how much they save and their wider investment and economic choices.
Key questions these newly linked datasets could help to address include:
What are the factors that affect how people save for retirement? How has tax policy affected how much different types of people choose to save in a pension? How do pension contributions change as people move from employment to self-employment? AvailabilityIt is intended the private pensions linked datasets will be made available to external researchers via the Office for National Statistics Secure Research Service in late 2024 or 2025. This is subject to approval by the data owner HMRC. Accredited researchers will need to submit a successful application to access the data.
Early pathfinder researchIn addition to creating the linked datasets, the project team will undertake research on the linked datasets. The answers to two research questions will provide important insight into the patterns of saving for the retirement of workers in the UK:
How much are people saving in personal pensions and how does this change over working life? How does pension saving change when someone moves from being employed to self-employed and was this pattern changed by the introduction of auto-enrolment?This research will serve as an early pathfinder project to demonstrate the real-world value of the new or improved data linkage.
Project details Project lead: Helen Miller Co-Investigator: Dr Jonathan Cribb Other researchers include Carl Emmerson, Heidi Karjalainen, Isaac Delestre, Laurence OâBrien Funded value: £178,666.17 (full economic cost) Duration: October 2022 â December 2024This project is funded via the ADR UK research-ready data and access fund, a dedicated fund for commissioning research using newly linked administrative data. The funding decision was based on advice from an independent expert panel, and in consultation with the Office for National Statistics. This project is part of the ADR England portfolio.
Details of the funding grant awarded by ADR UK for this project can also be found on the UK Research and Innovation (UKRI) Gateway to Research platform.
Source -
Trends in food poverty and linkages to health in Northern Ireland — unknown...
see more
Trends in food poverty and linkages to health in Northern Ireland
Where: unstated
When: 2023-2-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This project aims to produce a food poverty risk index for Northern Ireland. This will be used to investigate links between food poverty and nutritional deficiencies, and to answer the following questions:
What types of areas experience the greatest risk of food poverty? Have at-risk areas changed or persisted over time? What groups of people experience greater exposure to food poverty? How does food poverty impact on physical health? What interventions could be most effective at reducing the risk of food poverty?
Source -
ADR UK Research Fellows: The first users of the Data First probation and criminal justice linked datasets — unknown...
see more
ADR UK Research Fellows: The first users of the Data First probation and criminal justice linked datasets
Where: unstated
When: 2023-2-28
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding two Research Fellows for 12 months to conduct analysis using the newly available Ministry of Justice (MoJ) Data First probation and criminal justice system linked datasets. The research aims to improve our understanding of experiences of the criminal justice system.
The linking dataset enables probation data â containing information such as offences and community order requirements â to be linked with other MoJ Data First products, including magistratesâ courts, Crown Court, and prisoner custodial journey datasets. It acts as a lookup to identify where records in various datasets refer to the same people. This enables records to be grouped by individuals and repeat appearances across the criminal justice system to be investigated. All data is de-identified and stored and accessed securely in the Office for National Statistics (ONS) Secure Research Service.
The two Research Fellows will be the first to use these linked datasets for research in the public good and aligns with the MoJ Areas of Research Interest 2020 â such as reducing re-offending, protecting the public from harm, and improving life chances.
Learn more about the Research Fellows and their projects below.
Source -
Trends in food poverty and linkages to health in Northern Ireland — unknown...
see more
Trends in food poverty and linkages to health in Northern Ireland
Where: unstated
When: 2023-2-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This project aims to produce a food poverty risk index for Northern Ireland. This will be used to investigate links between food poverty and nutritional deficiencies, and to answer the following questions:
What types of areas experience the greatest risk of food poverty? Have at-risk areas changed or persisted over time? What groups of people experience greater exposure to food poverty? How does food poverty impact on physical health? What interventions could be most effective at reducing the risk of food poverty?
Source -
ID-307: Harrow NHS Health Checks – Activity, Access and Outcomes — Harrow Council...
see more
ID-307: Harrow NHS Health Checks – Activity, Access and Outcomes
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Harrow Council
Description: Diabetes.
Source -
ID-306: EXHALE 4 &2 – Find and Recruit using FARSITE — Imperial College Health Partners...
see more
ID-306: EXHALE 4 &2 – Find and Recruit using FARSITE
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Asthma. Commercial
Source -
ID-300: Cluster analysis of patients with pre-metabolic and metabolic syndrome to determine their association with pathological outcomes, to aid the generation of pre-emptive therapeutic targeting utilising artificial intelligence – approved subject to amending 4.2 — Imperial College Healthcare NHS Trust/Imperial College London...
see more
ID-300: Cluster analysis of patients with pre-metabolic and metabolic syndrome to determine their association with pathological outcomes, to aid the generation of pre-emptive therapeutic targeting utilising artificial intelligence – approved subject to amending 4.2
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/Imperial College London
Description: Metabolic Syndrome. Commercial
Source -
ID-301: Innovation for Healthcare Inequalities Programme (InHIP) focusing on Atrial Fibrillation in North West London — Imperial College Health Partners...
see more
ID-301: Innovation for Healthcare Inequalities Programme (InHIP) focusing on Atrial Fibrillation in North West London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Cardiology.
Source - and 12 more projects — click to show
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ID-309: Extension: Grenfell Bereaved and Survivors Population Health Monitoring — Westminster City Council...
see more
ID-309: Extension: Grenfell Bereaved and Survivors Population Health Monitoring
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Grenfell.
Source -
ID-298: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease — Lane Clark & Peacock LLP...
see more
ID-298: Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Cardiovascular. Commercial
Source -
ID-312: Extension: JSNA Program — Westminster City Council...
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ID-312: Extension: JSNA Program
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Population Health.
Source -
ID-302: NWL Population Health Accelerator (Hypertension) – approved subject to amending the form to reflect committee members’ comments — Boston Consulting Group...
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ID-302: NWL Population Health Accelerator (Hypertension) – approved subject to amending the form to reflect committee members’ comments
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Boston Consulting Group
Description: Hypertension.
Source -
ID-304: TRICORDER – Triple Cardiovascular Disease Detection with an Artificial Intelligence-Enabled Stethoscope — Imperial College London...
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ID-304: TRICORDER – Triple Cardiovascular Disease Detection with an Artificial Intelligence-Enabled Stethoscope
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Cardiology. Commercial
Source -
ID-299: Extension: Estimating inequalities in unmet clinical need in patients with obesity — Lane Clark & Peacock LLP...
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ID-299: Extension: Estimating inequalities in unmet clinical need in patients with obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Obesity. Commercial
Source -
ID-308: The comparative value of RWE as generated from the Systemic Anti Cancer Treatment database or trial evidence – approved subject to amending the form to reflect committee members’ comments — Department of Surgery & Cancer at Imperial College London...
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ID-308: The comparative value of RWE as generated from the Systemic Anti Cancer Treatment database or trial evidence – approved subject to amending the form to reflect committee members’ comments
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Department of Surgery & Cancer at Imperial College London
Description: Cancer. Commercial
Source -
ID-311: Extension: The incidence of common mental disorders in children and young people — Imperial College London...
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ID-311: Extension: The incidence of common mental disorders in children and young people
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental Health.
Source -
ID-303: Understanding demand for emergency care using regional routine data from emergency department and acute hospital admissions — Imperial College London...
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ID-303: Understanding demand for emergency care using regional routine data from emergency department and acute hospital admissions
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Emergency Care. Commercial
Source -
ID-297: Extension: Understanding the burden of severe infections in children in North West London. — Imperial College NHS Healthcare Trust...
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ID-297: Extension: Understanding the burden of severe infections in children in North West London.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College NHS Healthcare Trust
Description: Pediatrics.
Source -
ID-305: Case mix severity — Imperial College London...
see more
ID-305: Case mix severity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Emergency Care.
Source -
ID-310: Extension: Study to evaluate the healthcare needs of unpaid carers and looked after children — Imperial College Health Partners...
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ID-310: Extension: Study to evaluate the healthcare needs of unpaid carers and looked after children
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-23
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Carers. Commercial
Source
2023 - 01
-
Kidsâ Environment and Health Cohort — unknown...
see more
Kidsâ Environment and Health Cohort
Where: unstated
When: 2023-1-19
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Children are much more vulnerable to health-damaging features of the environment in and around their homes and schools than adults. This can include air pollution, overcrowding, fast food advertising near schools, and lack of access to greenspaces. Children who are exposed to these environmental factors are at greater risk of developing long-term conditions such as asthma or mental health problems, and not doing so well in school.
The government is introducing policies to improve local environments and housing, partly as a way to slow and mitigate the effects of climate change. There are also changes in the social environment around where children live and go to school, due to austerity policies and the Covid-19 pandemic, including closure of libraries, childcare providers and high street shops.
In this project, the team plans to set up a new national data resource that will allow researchers to examine how local physical and social environments influence childrenâs health and schooling across England.
The Kidsâ Environment and Health Cohort project is led by University College London, in collaboration with London School of Hygiene and Tropical Medicine, and City, University of London. This is in partnership with the Office for National Statistics (ONS), working with NHS Digital and the Department for Education.
Source -
ID-292: Extension: Children’s health monitoring — Westminster City Council...
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ID-292: Extension: Children’s health monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Pediatrics.
Source -
ID-289: Extension: Long Covid Multidisciplinary consortium: Optimising Treatments and servIces across the NHS (LOCOMOTION) — Imperial College London...
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ID-289: Extension: Long Covid Multidisciplinary consortium: Optimising Treatments and servIces across the NHS (LOCOMOTION)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Covid-19. Commercial
Source -
ID-294: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment – approved subject to implementing amendments suggested by committee members — London Borough of Hounslow...
see more
ID-294: JSNA and JSNA related projects for London Borough of Hounslow, including the Children and Young People Needs Assessment – approved subject to implementing amendments suggested by committee members
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: London Borough of Hounslow .
Source -
ID-293: Extension: Grenfell population health monitoring — Westminster City Council...
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ID-293: Extension: Grenfell population health monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Grenfell.
Source -
ID-291: Extension: Registered vs Census population comparison — Westminster City Council...
see more
ID-291: Extension: Registered vs Census population comparison
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Census.
Source -
ID-296: Extension: Factors influencing uptake of seasonal influenza vaccination amongst pregnant women — Imperial College London...
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ID-296: Extension: Factors influencing uptake of seasonal influenza vaccination amongst pregnant women
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Influenza.
Source -
ID-290: Extension: Autism in WCC and RBKC — Westminster City Council...
see more
ID-290: Extension: Autism in WCC and RBKC
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-23
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Autism.
Source
2022 - 12
-
System Control Centre Tool for Operational Flow — Carnall Farrar...
see more
System Control Centre Tool for Operational Flow
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-22
Opt Outs: no information provided./p>
Organisations: Carnall Farrar, Accenture, Palantir commissioned by NHS England’s CDAO
Description: Electric Health Records.
Source -
Extension: FARSITE — Imperial College Health Partners...
see more
Extension: FARSITE
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-22
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: FARSITE.
Source -
Extension: Care coordination for Adolescents in Crisis — Imperial College London ...
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Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental Health.
Source -
Extension: Carers Strategy — London Borough of Hammersmith and Fulham...
see more
Extension: Carers Strategy
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-22
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith and Fulham
Description: Carers.
Source -
Extension: Investigating integrated health care systems for children and young people (CYP) — Imperial College London ...
see more
Extension: Investigating integrated health care systems for children and young people (CYP)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Pediatrics.
Source -
Predict: Understanding the winter pattern of three main respiratory viruses to predict near real time health care utilisation — Imperial College London ...
see more
Predict: Understanding the winter pattern of three main respiratory viruses to predict near real time health care utilisation
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Respiratory Infections. Commercial
Source
2022 - 11
-
Polypharmacy — Imperial College London...
see more
Polypharmacy
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Polypharmacy .
Source -
ID-280: Extension: Quality of secondary prevention following perutaneous coronary intervations in North West London — Royal Brompton & Harefield Hospitals NHS Trust...
see more
ID-280: Extension: Quality of secondary prevention following perutaneous coronary intervations in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Royal Brompton & Harefield Hospitals NHS Trust
Description: Cardiovascular.
Source -
Extension: Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in Northwest London — The Open University ...
see more
Extension: Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: The Open University
Description: Personality Disorder.
Source -
The Economic Impact of Pneumonia across Health and Social Care Settings — Imperial College Health Partners...
see more
The Economic Impact of Pneumonia across Health and Social Care Settings
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Pneumonia. Commercial
Source -
Extension: Characterizing and Preventing Multimorbidity in NW London — Imperial College London...
see more
Extension: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity.
Source -
Extension: Improving patient outcome prediction for patients based on health records — Imperial College London ...
see more
Extension: Improving patient outcome prediction for patients based on health records
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Electric Health Records.
Source -
Extension: Carers Strategy — London Borough of Hammersmith and Fulham...
see more
Extension: Carers Strategy
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith and Fulham
Description: Carers.
Source -
Extension: Mapping the clinical journey of patients with Chronic Kidney Disease (CKD) in North West London (NWL) — Imperial College Healthcare NHS Trust/Imperial College London...
see more
Extension: Mapping the clinical journey of patients with Chronic Kidney Disease (CKD) in North West London (NWL)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/Imperial College London
Description: Kidney Disease. Commercial
Source -
Extension: Multimorbidity Clustering — Imperial College London...
see more
Extension: Multimorbidity Clustering
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity.
Source -
Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London. — Department of Primary Care & Public Health...
see more
Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Department of Primary Care & Public Health, Imperial College London
Description: multimorbidity in depression .
Source - and 2 more projects — click to show
-
Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling — Imperial College Healthcare NHS Trust/ Imperial College London...
see more
Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ Imperial College London
Description: Neurological conditions. Commercial
Source -
Study to evaluate safety, tolerability and pharmacokinetics, with target occupancy study of BIIB113 in healthy participants — Imperial College Health Partners...
see more
Study to evaluate safety, tolerability and pharmacokinetics, with target occupancy study of BIIB113 in healthy participants
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-22
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Alzheimer’s disease. Commercial
Source
2022 - 10
-
Extension: Evaluation of the online access route to general practice — Imperial Clinical Analytics Research & Evaluation (ICHNT) / NIHR Imperial Patient Safety Translational Research Centre ...
see more
Extension: Evaluation of the online access route to general practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-22
Opt Outs: no information provided./p>
Organisations: Imperial Clinical Analytics Research & Evaluation (ICHNT) / NIHR Imperial Patient Safety Translational Research Centre
Description: General Practice.
Source -
Extension: Impact of organisational models in general practice on patient safety and associated costs — Imperial College London...
see more
Extension: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: General Recruitment.
Source -
Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity. — Imperial College Health Partners...
see more
Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-22
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Obesity. Commercial
Source -
Extension: Estimating inequalities in burden of illness in patients with Alzheimer’s disease — Lane Clark & Peacock LLP...
see more
Extension: Estimating inequalities in burden of illness in patients with Alzheimer’s disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-22
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Alzheimer’s disease. Commercial
Source
2022 - 09
-
Extension: Mixed methods evaluation of the impact of the shift to remote consultation in primary and secondary care in London — missing...
see more
Extension: Mixed methods evaluation of the impact of the shift to remote consultation in primary and secondary care in London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: missing
Description: Remote Consultations.
Source -
Improving management of severe Asthma in North West London (NWL) through Trust Primary Care networks (PCN) joint working model of virtual multidisciplinary patients review. — Imperial College Healh Partners...
see more
Improving management of severe Asthma in North West London (NWL) through Trust Primary Care networks (PCN) joint working model of virtual multidisciplinary patients review.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healh Partners
Description: Asthma. Commercial
Source -
Extension: Understanding the impact of CLCH community services on patient health in NW London — CLCH...
see more
Extension: Understanding the impact of CLCH community services on patient health in NW London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: CLCH
Description: CLCH community services .
Source -
Extension: Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in North West London — The Open University ...
see more
Extension: Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: The Open University
Description: Personality Disorder.
Source -
Extension: Characterising clusters of multimorbidity, trajectories and associations with clinical outcomes and healthcare utilisation: — Imperial College London/ NIHR Applied Research Collaboration North West London...
see more
Extension: Characterising clusters of multimorbidity, trajectories and associations with clinical outcomes and healthcare utilisation:
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: Imperial College London/ NIHR Applied Research Collaboration North West London
Description: Multimorbidity .
Source -
Harrow Health & Wellbeing Profile (JSNA) — Harrow Council...
see more
Harrow Health & Wellbeing Profile (JSNA)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: Harrow Council
Description: JSNA.
Source -
Extension: JSNA Programme — Westminster City Council...
see more
Extension: JSNA Programme
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: JSNA.
Source -
Extension: Characterizing and Preventing Multimorbidity in NW London — Imperial College London...
see more
Extension: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research/ Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity .
Source
2022 - 08
-
Engaging with Children — unknown...
see more
Engaging with Children
Where: unstated
When: 2022-8-10
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Childrenâs rights are central to everything that we do with childrenâs data. We want to make sure that children and young people have a say in how their data is used and communicated. In this new pilot project, ADR Scotland is working in partnership with Children in Scotland to talk with children and young people directly to learn about their views on administrative data, how it is collected, stored and used and to discuss how results of research projects using data are communicated.
Source -
Improving the UEC pathway across NWL using population health data
— McKinsey and Company ...
see more
Improving the UEC pathway across NWL using population health data
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: McKinsey and Company
Description: UEC Pathways . Commercial
Source -
ID-263: Harrow Integrated Intermediate Care Programme — CLCH on behalf of the Harrow Borough...
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ID-263: Harrow Integrated Intermediate Care Programme
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: CLCH on behalf of the Harrow Borough-based Partnership
Description: Harrow.
Source -
Brent Long Term Health Conditions Dashboard
— London Borough of Brent...
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Brent Long Term Health Conditions Dashboard
Legal basis:Research/ Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: London Borough of Brent
Description: Brent .
Source -
Extension: Impact of Sotrovimab in Treatment of COVID-19 — Imperial Colleg Health Partners...
see more
Extension: Impact of Sotrovimab in Treatment of COVID-19
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: Imperial Colleg Health Partners
Description: COVID. Commercial
Source -
The impact of COVID-19 on antibiotic prescribing in North West London
— Imperial College London...
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The impact of COVID-19 on antibiotic prescribing in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Antibiotics .
Source -
Grenfell Bereaved and Survivors Population Health Monitoring
— Westminster City Council...
see more
Grenfell Bereaved and Survivors Population Health Monitoring
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Grenfell .
Source -
Extension: The incidence of common mental disorders in children and
young people — Imperial College London...
see more
Extension: The incidence of common mental disorders in children and
young peopleLegal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental Health.
Source -
EXHALE programme – patient participation and engagement — Imperial College Healthcare NHS Trust ...
see more
EXHALE programme – patient participation and engagement
Legal basis:Cohort Recruitment
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Cohort Recruitment. Commercial
Source
2022 - 07
-
ADR UK Research Fellows: Grading and Admissions Data for England — unknown...
see more
ADR UK Research Fellows: Grading and Admissions Data for England
Where: unstated
When: 2022-7-20
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding a 12-month Research Fellowship to conduct analysis using the newly available Grading and Admissions Data for England (GRADE).
ADR UK Research Fellow Dr Konstantina Maragkou will use key data about centre assessment grades and calculated grades in 2020, when assessment practices were changed as a result of the Covid-19 pandemic. Research using this de-identified data has the potential to generate better understanding of the impact of these assessment policies on students and schools.
Source -
Ethnic Disparities in Quality of Care Among Type 2 Diabetic Patients Before and During the COVID-19 Pandemic: A Before and After Study Using UK Electronic Health Records — Rohini Mathur ...
see more
Ethnic Disparities in Quality of Care Among Type 2 Diabetic Patients Before and During the COVID-19 Pandemic: A Before and After Study Using UK Electronic Health Records
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-07-29
Organisations:
Rohini Mathur - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yunqing Zhu - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
There are three main outcomes of interest: (1) blood pressure measurement, (2) blood sugar measurement (HbA1c), and (3) foot examination
Description: Lay Summary
The 2019 novel coronavirus has rapidly spread throughout the world, involving more than 100 million individuals and their related chronic conditions could have adverse implications due to the pandemic. Diabetes represents one of the most prevalent chronic diseases worldwide, it's estimated that about half a billion people have diabetes and this number is likely to increase by 25% in 2030. Specifically, the most common form of diabetes is type 2 diabetes, which is a leading cause of mortality. Research on these two diseases is of increasing relevance since they both are conditions that are widespread in the world today. However, previous research has mostly covered the direct risks of COVID-19 among type 2 diabetic patients but currently, there are limited comprehensive studies aiming to address the indirect effects of COVID-19, such as its impacts on the quality of care.
The overall aim of this study is to determine factors such as ethnicity, age, sex, and health status, that influences quality of care among type 2 diabetic patients in the context of COVID-19 in the United Kingdom. Data will be assessed using electronic health records from the Clinical Practice Research Datalink, where participants will be recruited based on their type 2 diabetes diagnosis. This study is a prospective cohort study to further explore the association between the quality of diabetic care during the pandemic and comparing this to pre-pandemic levels. Data analysis will be performed using survival analysis and recommendations will be made to reduce existing social inequalities in diabetic care.
Technical SummaryEthnic disparities in T2DM diagnosis and care remain a pervasive health problem in the UK. Studies have reported higher prevalence of T2DM among ethnic minorities, with Asians and Blacks having 2-4 times the T2DM prevalence compared to Whites (Whicher et al, 2020). There are also recognized inequalities in healthcare services, which may have been exacerbated by COVID-19. Currently, there are no known UK studies that address ethnic disparities in T2DM health checks, comparing care indicators before and during the pandemic.
This study uses primary care data to compare ethnic differences in routine health checks for T2DM patients before and during COVID-19. Ethnic minorities are disproportionally affected by T2DM, and by changes in healthcare delivery imposed by COVID-19, this study aims to observe variation in diabetes care by ethnicity. Since deprivation and ethnicity may overlap, the Index of Multiple Deprivation is used to explore how deprivation modifies the relationship between ethnicity and quality of diabetes care provision.
There will be two cohorts (1) pre-pandemic cohort where individuals with T2DM actively registered in the database on March 11, 2019 and (2) pandemic time cohort consisting of T2DM patients actively registered on March 11, 2021. WHO declared COVID-19 a pandemic on March 11, 2020, March 11, 2021 is chosen as the start of the pandemic time-cohort. To allow for the same analysis time, March 11, 2019, is used as the start of the pre-pandemic cohort. The same analysis is performed in both time-periods and is compared.
Quality of diabetes care is defined using three outcomes of interest: BP measurement, blood sugar measurement, and foot examination. Cox proportional hazards regression will quantify ethnic differences in time to receipt the care metrics separately for the pre-pandemic and pandemic cohort. Differences in the ethnic patterning of diabetes care between the two time-periods will be described qualitatively.
Source -
Extension: Impact of Sotrovimab in Treatment of COVID-19
— Imperial College Health Partners...
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Extension: Impact of Sotrovimab in Treatment of COVID-19
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: COVID-19 . Commercial
Source -
Extension: Children’s health monitoring
— Westminster City Council...
see more
Extension: Children’s health monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Children’s health monitoring .
Source -
Extension: Estimating inequalities in unmet clinical need in patients with obesity
— Lane Clark & Peacock LLP ...
see more
Extension: Estimating inequalities in unmet clinical need in patients with obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Obesity . Commercial
Source -
IIdentifying and investigating health outcomes of young people with multiple disadvantage in Northwest London
— Imperial College Healthcare NHS Trust...
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IIdentifying and investigating health outcomes of young people with multiple disadvantage in Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Young people with multiple disadvantage .
Source -
Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
— Lane Clark & Peacock LLP ...
see more
Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Cardiovascular disease . Commercial
Source -
Extension: Care Strategy
— London Borough of Hammersmith & Fulham ...
see more
Extension: Care Strategy
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith & Fulham
Description: Carers .
Source -
Extension: Local-level analysis for the REAL Centre second annual report — The Health Economics Unit at Midlands and Lancashire CSU (MLCSU)...
see more
Extension: Local-level analysis for the REAL Centre second annual report
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: The Health Economics Unit at Midlands and Lancashire CSU (MLCSU)
Description: Local-level analysis . Commercial
Source -
Provision of Neuro rehabilitation services in NWL
— Imperial College London...
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Provision of Neuro rehabilitation services in NWL
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Neurological conditions .
Source - and 3 more projects — click to show
-
Extension: Grenfell population health monitoring
— Westminster City Council...
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Extension: Grenfell population health monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: North Kensington .
Source -
Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
— Imperial College Healthcare NHS Trust/ Imperial College London...
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Extension: Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ Imperial College London
Description: Dementia, frailty and complex neurological conditions . Commercial
Source -
Extension: Study to evaluate the healthcare needs of unpaid carers and looked after children
— Imperial College Health Partners...
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Extension: Study to evaluate the healthcare needs of unpaid carers and looked after children
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-22
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Unpaid carers/ looked after children . Commercial
Source
2022 - 06
-
Trends and inequalities in statin use for the primary and secondary prevention of cardiovascular disease — Krishnan Bhaskaran ...
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Trends and inequalities in statin use for the primary and secondary prevention of cardiovascular disease
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-06-01
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rutendo Muzambi - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
1) Monthly proportion current statin users,
2) Monthly proportion of patients with a recorded cardiovascular risk score,
3) Monthly proportion of first ever statin prescription,
4) Time from initiation to discontinuation of statins.
5) Time from statin cessation to first subsequent statin prescription
6) Number of cardiovascular events prevented with optimal statin useDescription: Lay Summary
Cardiovascular disease, which includes strokes and heart attacks, is a leading cause of death in the UK and globally. Statins have been proven to be effective in reducing cardiovascular events and guidelines recommend the use of statins in those at risk of developing or with known cardiovascular disease. Despite this, previous studies suggest statins are under-prescribed and underused which leads to preventable heart attacks, strokes, and death. Previous studies have shown that certain patient groups such as ethnic minorities and older age groups are less likely to receive treatment. However, trends in statin prescribing and ongoing use in recent years are unclear. Additionally given the potential impact of the COVID-19 pandemic, it is also important to examine how statin use changed during the pandemic.
Our study will use anonymous GP and hospital records to determine the proportion of patients starting and continuing or stopping statins over time between 2009 and 2021. We will explore characteristics associated with statin use. We will also investigate the impact of the COVID-19 pandemic on statin use. This study will provide insight on whether statin guidelines are being followed and which patient groups are missing out on statins or stopping treatment. Our findings will inform strategies to improve statin uptake.
Technical SummaryStatins are effective in the primary and secondary prevention of cardiovascular disease. Guidelines for the primary prevention of cardiovascular disease recommend prescribing statins in those with a 10-year cardiovascular risk score of 10% or higher from 2014 onwards or a 20% risk between 2005 and 2013. Secondary prevention of statins is recommended for all patients who have already had a cardiovascular event. However, previous studies suggest that these medicines are under-prescribed, which results in preventable cardiovascular outcomes and mortality. Previous studies also suggest there are inequalities in statin prescribing with certain patient groups such as ethnic minorities and older age groups less likely to receive treatment. Adherence to statins has been known to be poor thus limiting the potential for cardiovascular disease prevention. In more recent years, statin adherence and uptake may have been impacted by the COVID-19 pandemic which led to a dramatic reduction in access to health care services.
We will use data from the Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) to carry out a cohort study, examining trends and factors associated with statin prevalence, cardiovascular risk scoring and initiation of statins between 2009 and 2021. We will also examine trends and factors associated with statin persistence and cessation and we will estimate the number of cardiovascular events that can be prevented with optimal statin use. We will explore statin prevalence, initiation and persistence in the pre-pandemic and pandemic period. Our study will provide insight on the extent to which cardiovascular prevention guidelines for statins are being implemented, better understanding of any disparities in statin prescribing and inform strategies to improve statin uptake and future planning for pandemics.
Source -
Extension: Use of artificial intelligence applied to routine clinical and administrative healthcare data to identify people at risk of serious acute illness from COVID-19 infection.
— Imperial College London...
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Extension: Use of artificial intelligence applied to routine clinical and administrative healthcare data to identify people at risk of serious acute illness from COVID-19 infection.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: COVID-19 . Commercial
Source -
Extension: Understanding the burden of severe infections in children in North West London
— Imperial College Healthcare NHS Trust...
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Extension: Understanding the burden of severe infections in children in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Severe infections in children .
Source -
Extension: Registered vs Census population comparison
— Westminster City Council...
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Extension: Registered vs Census population comparison
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Census .
Source -
Extension: Improving patient outcome prediction for patients based on health records
— Imperial College London...
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Extension: Improving patient outcome prediction for patients based on health records
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Patient outcomes .
Source -
Long Covid Multidisciplinary consortium: Optimising Treatments and servIces across the NHS (LOCOMOTION)
— Imperial College London...
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Long Covid Multidisciplinary consortium: Optimising Treatments and servIces across the NHS (LOCOMOTION)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Long COVID . Commercial
Source -
Mapping the clinical journey of patients with Chronic Kidney Disease (CKD)in North West London (NWL) — Imperial College Healthcare NHS Trust/ Imperial College London...
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Mapping the clinical journey of patients with Chronic Kidney Disease (CKD)in North West London (NWL)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ Imperial College London
Description: Chronic Kidney Disease .
Source -
Extension: Autism in WCC and RBKC
— Westminster City Council...
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Extension: Autism in WCC and RBKC
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Autism – Westminster and Kensington and Chelsea .
Source -
All JSNA’s for Brent, including Children & Young People JSNA (CYP JSNA)
— London Borough of Brent...
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All JSNA’s for Brent, including Children & Young People JSNA (CYP JSNA)
Legal basis:Research/ Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: London Borough of Brent
Description: JSNA .
Source -
Primary Care Network Analysis
— Imperial College Healthcare NHS Trust...
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Primary Care Network Analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Primary Care .
Source -
FARSITE
— NorthWest EHealth (NWEH) ...
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FARSITE
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-22
Opt Outs: no information provided./p>
Organisations: NorthWest EHealth (NWEH)
Description: FARSITE .
Source
2022 - 05
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Extension: Supporting early feasibility for non-commercial studies in North West London — Imperial College Healthcare NHS Trust...
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Extension: Supporting early feasibility for non-commercial studies in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Feasibility .
Source -
Extension: Care coordination for Adolescents in Crisis
— Imperial College London...
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Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental Health.
Source -
Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity.
— ICHP...
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Extension: A retrospective study: patient pathway and healthcare utilisation during the management of Obesity.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Obesity . Commercial
Source -
Extension: NW London Imaging Network – Community Diagnostics Centre (CDC) Population Health Project — Imperial College Healthcare NHS Trust...
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Extension: NW London Imaging Network – Community Diagnostics Centre (CDC) Population Health Project
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Community Diagnostics .
Source -
Extension: Investigating integrated health care systems for children and young people (CYP)
— Imperial College London...
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Extension: Investigating integrated health care systems for children and young people (CYP)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Integrated health care systems .
Source -
Extension: Factors influencing uptake of seasonal influenza vaccination amongst pregnant women — Imperial College Healthcare NHS Trust...
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Extension: Factors influencing uptake of seasonal influenza vaccination amongst pregnant women
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Seasonal Influenza.
Source -
Extension: Quality of secondary prevention following percutaneous coronary interventions in North West London — Royal Brompton & Harefield Hospitals NHS Trust...
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Extension: Quality of secondary prevention following percutaneous coronary interventions in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Royal Brompton & Harefield Hospitals NHS Trust
Description: Percutaneous coronary interventions.
Source -
Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London.
— Imperial College London...
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Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation in Northwest London.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity in depression . Commercial
Source
2022 - 04
-
COVID-19 Therapeutics (Pseudonymised) (Secondary Uses ) — NHS England & Improvement...
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Dissemination of psuedonymised therapeutics data relating to people who have certain clinical conditions. , NHS England have the requirement to access data which is relevant to the deployment of COVID-19 therapeutic treatments to effectively discharge its responsibilities ⢠Firstly, an important piece of the reporting work will focus on health inequalities and evaluation of patient care ⢠Secondly, this data will be used to enable NHS England to understand and report on reasons for non-treatment of patients — IG-00497_7
Recipient Data Controller Organisation(s) : NHS England & Improvement
Approval Date: 13/04/2022
Purpose for which the data is being used: Dissemination of psuedonymised therapeutics data relating to people who have certain clinical conditions. , NHS England have the requirement to access data which is relevant to the deployment of COVID-19 therapeutic treatments to effectively discharge its responsibilities ⢠Firstly, an important piece of the reporting work will focus on health inequalities and evaluation of patient care ⢠Secondly, this data will be used to enable NHS England to understand and report on reasons for non-treatment of patients
Dataset: COVID-19 Therapeutics
Category of Data: Pseudonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 9(2)(g) â substantial public interest, plus Part 2 Sched 1 DPA18, para 6 statutory and governmental purpose re COPI
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 6 (1) e public task â COPI Regs GDPR Article 9(2)(h) â healthcare purposes, plus Part 1 Sched 1 DPA18, para 2 health or social care purpose
National Data Opt-out Applied: Not applied - legal obligation overrides
Source -
Safety of COVID-19 vaccination during pregnancy in England: a cohort study — Jemma Walker ...
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Safety of COVID-19 vaccination during pregnancy in England: a cohort study
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-04-28
Organisations:
Jemma Walker - Chief Investigator - MHRA
Helen McDonald - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - MHRA
Jennifer Campbell - Collaborator - CPRD
Katherine Donegan - Collaborator - MHRA
Maria Peppa - Collaborator - University College London ( UCL )
Nick Andrews - Collaborator - Public Health EnglandOutcomes:
Primary: Stillbirth; maternal death; maternal venous thromboembolism; preterm delivery; neonatal death; major congenital malformations.
Secondary: extended perinatal death (stillbirth or neonatal death)
Description: Lay Summary
COVID-19 can cause serious illness in pregnant women. Since April 2021, all pregnant women in the UK have been routinely advised to receive COVID-19 vaccination together with the rest of the population, according to their age and underlying health conditions. Because mRNA vaccines have been given in pregnancy in the United States with reassuring findings from safety surveillance, these have been the preferred vaccines to offer to pregnant women in England. It is important to study the safety of new COVID-19 vaccination during pregnancy in England, to add to the available evidence internationally on the safety of COVID-19 vaccination in pregnancy, and to support appropriate confidence in vaccination.
We will compare the outcomes of pregnant women who were vaccinated against COVID during pregnancy to those of women who were pregnant before the COVID-19 pandemic, and to women who were pregnant during the COVID-19 pandemic but who were not vaccinated during pregnancy. We will look at venous blood clots during pregnancy, stillbirth, premature birth, death of the mother, death of a baby soon after birth, and major birth defects.
This study will inform advice to pregnant women by the UK Health Security Agency (formerly Public Health England) and the Medicines and Healthcare products Regulatory Agency.
Technical SummaryPregnant women are at risk of severe outcomes from COVID-19 infection and are recommended COVID-19 vaccination in the UK and other countries. Safety surveillance to date has been reassuring. However, there is a need for epidemiological studies of COVID-19 vaccination safety during pregnancy to add to the international evidence base and to support appropriate public confidence in vaccination.
The study will use a matched cohort study design to examine whether there is any association between COVID-19 vaccination during pregnancy and adverse maternal, foetal or infant outcomes (maternal venous thromboembolism, stillbirth, maternal death, neonatal death, premature birth, and major congenital anomalies).
The CPRD Pregnancy Register will be used to define a cohort of eligible pregnant women. The main analysis will compare adverse outcomes among women vaccinated in pregnancy to historical controls who were pregnant prior to the COVID-19 pandemic, matched on maternal age. Multivariable Cox regression models will be used to adjust for confounding by gestational age for analyses of venous thromboembolism, stillbirth, maternal death and preterm delivery, and to adjust for ascertainment increasing with length of follow up for major congenital anomalies. A multivariable logistic regression model will be used for analysis of neonatal mortality. A secondary analysis will compare women vaccinated in pregnancy to unvaccinated concurrent pregnant controls, matched on maternal age and expected delivery date (by month).
The study will be conducted in two analysis stages, with a first analysis in early 2022 focused on mRNA platform vaccines to provide indicative results swiftly for policy-makers (maternal outcomes will be followed by infant outcomes if the mother-baby link is not initially available), followed by more precise estimates and secondary analyses (such as brand-specific analysis and analysis by trimester of vaccination) once there is greater power and follow-up time available in late 2022.
Source -
Determinants of COVID-19 outcomes, and interactions with non-communicable disease, amongst South Asians in the United Kingdom
— Imperial College London...
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Determinants of COVID-19 outcomes, and interactions with non-communicable disease, amongst South Asians in the United Kingdom
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Covid-19.
Source -
Impact of ethnicity on adverse maternal outcomes in Northwest London
— Imperial College London...
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Impact of ethnicity on adverse maternal outcomes in Northwest London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Adverse maternal health outcomes .
Source -
Extension: Impact of organisational models in general practice on patient safety and associated costs
— Imperial College London...
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Extension: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Patient Safety.
Source -
Extension: Evaluation of the impact of the ‘total triage’ model using online consultations in general practice
— Imperial College Healthcare NHS Trust...
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Extension: Evaluation of the impact of the ‘total triage’ model using online consultations in general practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Online consultations .
Source -
Imperial ENT/ NW London Elective Risk Stratification and remote monitoring pilot
— C2...
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Imperial ENT/ NW London Elective Risk Stratification and remote monitoring pilot
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: C2-AI
Description: ENT Pathway.
Source -
Extension: T2D Fresh Start
— Imperial College London...
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Extension: T2D Fresh Start
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Type 2 Diabetes .
Source -
Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
— Imperial College Healthcare NHS Trust/ UK DRI Care Research and Technology Centre at Imperial College London ...
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Improving care for people with dementia, frailty and complex neurological conditions through data integration and predictive modelling
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust/ UK DRI Care Research and Technology Centre at Imperial College LondonÂ
Description: Dementia . Commercial
Source -
Analysis of prescription pattern and asthma attacks in children and young people in Northwest London
— Imperial College London...
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Analysis of prescription pattern and asthma attacks in children and young people in Northwest London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Asthma.
Source - and 3 more projects — click to show
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Extension: FARSITE
— ICHP...
see more
Extension: FARSITE
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: FARSITE. Research
Source -
Extension: Characterizing and Preventing Multimorbidity in NW London
— Imperial College London...
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Extension: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research/ Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity.
Source -
Health inequalities in elective treatment pathways during COVID-19 pandemic
— Imperial College London...
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Health inequalities in elective treatment pathways during COVID-19 pandemic
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Health Inequalities (Covid).
Source
2022 - 03
-
Has the incidence of giant cell arteritis in England and Northern Ireland been influenced by the covid-19 pandemic? A case cohort study using CPRD Aurum data — Sarah Skeoch ...
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Has the incidence of giant cell arteritis in England and Northern Ireland been influenced by the covid-19 pandemic? A case cohort study using CPRD Aurum data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-09
Organisations:
Sarah Skeoch - Chief Investigator - University of Bath
Ben Mulhearn - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Jessica Ellis - Collaborator - University of Bath
John Pauling - Collaborator - University of Bath
Julia Snowball - Collaborator - University of Bath
Neil McHugh - Collaborator - University of Bath
Rachel Charlton - Collaborator - University of Bath
Sarah Tansley - Collaborator - University of BathOutcomes:
Incident cases of GCA; Visual loss
Description: Technical Summary
We witnessed an increase in the incidence of GCA during the COVID-19 pandemic, with peaks in incidence rates following peaks in COVID-19 prevalence in the local area (Bath, Somerset). The aim of this study is to investigate if COVID-19 infection has increased the incidence of GCA, and to evaluate the temporal relationship between COVID-19 and onset of GCA.
The study population of interest will be all adults aged 50 or over, which is the at-risk population for developing GCA. Primary exposure will be COVID-19 infection and primary outcome will be the development of a new case of GCA as coded in the CPRD Aurum dataset. The design will be a case cohort study which will allow determination odds ratios and hazard ratios of developing GCA after infection with COVID-19. The effect of the covariates age, gender, smoking status, BMI, vaccination status and comorbidity will also be evaluated. The latency period between COVID-19 infection and GCA diagnosis will be estimated from the data.
This study will provide further evidence for the viral hypothesis of GCA to raise public awareness of the disease and may help in future to develop early warning scores to be able to detect GCA sooner to prevent sequelae such as irreversible visual loss.
Source -
Investigating disruptions in primary care as a result of the COVID-19 pandemic and the introduction of national lockdowns — Kamlesh Khunti ...
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Investigating disruptions in primary care as a result of the COVID-19 pandemic and the introduction of national lockdowns
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-14
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Tom Norris - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Samuel Seidu - Collaborator - Leicester Diabetes CentreOutcomes:
Weekly consultation counts; consultation type; consultation duration; referrals to outpatient services; incidence of first diagnoses of cardio-metabolic conditions; indicators of risk factor control (e.g. blood pressure, lipids, HbA1c, BMI, medication adherence (medication possession rate) and smoking status); medium to long-term outcomes (cardiovascular events, mortality, and hospital admission).
Description: Technical Summary
This study aims to describe temporal trends in the provision of primary care in the UK before, during and after the introduction of COVID-19 national lockdowns. Studies have reported a reduction in A&E attendance and admissions at secondary care settings but less is known about the disruptions to care delivered in primary care settings. In this study, our exposure(s) will be the introduction of the national lockdowns. We will utilise an interrupted time series (ITS) framework (with time divided into before, during and between the introduction of national lockdowns and also a longer-term post-lockdown period representing the next phase of the COVID-19 pandemic) and use negative binomial regression models to estimate weekly events (e.g., primary care consultations, referrals to outpatients). We will also assess trends in risk factor control pre and post the start of the pandemic (March 2020); and determine the association between both risk factor control and medium to long-term outcomes, primarily cardiovascular events, mortality, and hospital admission.
We will also assess whether the disruption in the provision of primary care has been equitable across different population subgroups, e.g., across different age, ethnic and deprivation groups.
Source -
Healthcare Resource Utilisation and Associated Costs in Patients with COVID-19 in England: A Retrospective Cohort Study — Vishal Patel ...
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Healthcare Resource Utilisation and Associated Costs in Patients with COVID-19 in England: A Retrospective Cohort Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-23
Organisations:
Vishal Patel - Chief Investigator - GSK
Sue Beecroft - Corresponding Applicant - Harvey Walsh Ltd
Adeola Oliyide - Collaborator - GlaxoSmithKline - UK
Daniel Gibbons - Collaborator - GSK
David Heaton - Collaborator - Harvey Walsh Ltd
Gethin Griffith - Collaborator - GSK
Gillian Hall - Collaborator - Gillian Hall Epidemiology Ltd
Puneeth Mandaknallikar - Collaborator - GSK
Xiaocong Marston - Collaborator - Harvey Walsh LtdOutcomes:
Age; sex; COVID-19 diagnosis; COVID-19 test result; COVID-19 high-risk categories including obese / overweight; pregnant; chronic kidney disease; chronic liver disease; diabetes mellitus; primary immune deficiencies; immunosuppressed state (including diseases of the spleen); immune-mediated inflammatory disorders; solid cancers; haematological diseases and stem cell transplant recipients; HIV / AIDS â where recorded; stroke / cerebrovascular disease; heart conditions; hypertension; chronic lung diseases; dementia and other neurological conditions; motor neurone disease; multiple sclerosis; Downâs syndrome; death; COVID-19 wave, healthcare resource use (admitted patient care, A&E; primary care; critical care); respiratory support (Extracorporeal Membrane Oxygenation (ECMO); invasive ventilation; non-invasive ventilation); HCRU costs.
Description: Technical Summary
This descriptive cohort study will estimate the primary and secondary healthcare resource utilisation (HCRU) and associated costs in a population with known COVID-19 (diagnosis or positive test) and at high-risk of severe disease in England. The proportion of high-risk patients with known COVID-19 who are hospitalised, and the proportion of hospitalised patients admitted to critical care, will also be estimated.
High-risk patients will be those permanently registered on CPRD for >6 months when aged >55 years, or >12 years with a CPRD or HES record of co-morbidities considered high-risk for severe COVID-19. Hospitalisations will be those recorded on the HES Admitted Patient Care file (APC). Nosocomial disease will be excluded. The Second Generation Surveillance System, CPRD and HES will provide COVID-19 infection data and ONS Death Registration Data will provide death records. HCRU will be that on CPRD and HES APC and Accident and Emergency (A&E) files, with costs from NHS Reference, Personal Social Services Research Unit and NHS Digital prescribing costs as appropriate.
All analyses will be descriptive. The population will be described in terms of demographics, HCRU in the acute phase of 29 days from diagnosis (overall and by critical care, non-critical care, A&E and primary care), and associated costs reported. The proportion of patients with known COVID-19 and at high risk of severe disease who were then hospitalised will be estimated after testing increased in September 2020. The proportion of these hospitalised patients who were then admitted to critical care will also be estimated. Both sets of analyses will be repeated in sub-groups based on age, immunosuppressed status, COVID-19 wave and death.
The study results will provide a better understanding of the HCRU and associated costs due to COVID-19 in high-risk patients which is of public health interest and will allow estimation of cost-effectiveness of treatments.
Source -
Variations in the management of Inflammatory Bowel Disease over time: How has Covid-19 effected inflammatory bowel disease patients? — David Humes ...
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Variations in the management of Inflammatory Bowel Disease over time: How has Covid-19 effected inflammatory bowel disease patients?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-08
Organisations:
David Humes - Chief Investigator - University of Nottingham
Jennifer Couch - Corresponding Applicant - Nottingham University Hospitals
Timothy Card - Collaborator - University of Nottingham
Yue Huang - Collaborator - University of NottinghamOutcomes:
⢠Rates of emergency compared to elective surgery over time.
⢠Differences in adverse outcomes for IBD patients requiring emergency rather than elective surgery. Adverse outcomes will include mortality, length of stay, stoma rates and post operative complications including 30 day re-operation rates.
⢠The affect of the Covid-19 pandemic on elective and emergency surgery rates.
⢠Effect of medical treatment on elective and emergency colectomy rates over time.
⢠Effect of socioeconomic status on adverse outcomes and access to treatment.
⢠Variation in practice and outcomes between geographic regions.Description: Technical Summary
Inflammatory bowel disease (IBD) is a chronic, relapsing and remitting condition associated with significant morbidity and reduction in quality of life. IBD management has changed significantly in the last two decades. The increased use of biological therapies and widespread uptake of minimally invasive surgery has revolutionised medical and surgical management of IBD patients. These changes are likely to have influenced the number of patients requiring emergency surgery and its associated morbidity and mortality.
There is evidence suggesting socioeconomic status and where patients are treated may be associated with variations in both the treatment received by patients and their outcomes. The Covid-19 pandemic led to an overhaul in service delivery but the reconfiguration of services varied significantly from region to region. The effect of the above, particularly during the pandemic period on IBD patients is unknown.
Objectives:
To establish if emergency admissions and surgery for IBD patients has changed over time due to advances in medical and surgical practice.
To establish how elective surgery delivery has changed over time and how this has been affected by the pandemic.
To investigate if socioeconomic status and geographic region effects the treatment and outcomes of IBD patients.Design:
This will be a retrospective open cohort study of patients who have a known diagnosis of IBD between 2000 and 2021. Patients will be identified using Medcodes for IBD from CPRD and ICD 10 codes from HES data. Surgery will be defined by the OPCS codes from the linked HES data and socioeconomic status from CPRD linked small area data . Mortality will be defined from the Office of National Statistics data.We will calculate rates of surgery over time using an interrupted time analysis and model them with Poisson regression. We will calculate crude mortality rates and build appropriate Cox proportional hazards regression models.
Source -
Characterizing long COVID patients across pre-existing physical and mental health conditions: Risk profiling using Electronic Health Records in the United Kingdom — Amitava Banerjee ...
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Characterizing long COVID patients across pre-existing physical and mental health conditions: Risk profiling using Electronic Health Records in the United Kingdom
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Admitted Patient Care; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-18
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Laura Pasea - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Christina Van der Feltz-Cornelis - Collaborator - University of York
Han-I Wang - Collaborator - University of York
Mehrdad Alizadeh Mizani - Collaborator - University College London ( UCL )
Muhammad (Ashkan) Dashtban - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Yi Mu - Collaborator - University College London ( UCL )Outcomes:
⢠Long COVID symptom clusters
⢠All-cause and cause-specific mortality of patients with long COVID
⢠Newly developed LTCs among long COVID patients
⢠Newly developed mental health conditions among long COVID patients
⢠Healthcare resource use for patients with long COVIDDescription: Technical Summary
Long COVID research is helping to refine treatment strategies around the world. We aim to understand risks for developing long COVID conditions specifically among patients who suffer pre-existing long term conditions (LTCs) (e.g., Coronary Heart Disease, COPD, Diabetes, mast-cell activation syndrome, inflammatory condition/autoimmune disease, rheumatic arthritis) and mental health conditions (e.g., depression and anxiety) using NHS records. We will: (i) develop and validate EHR phenotypes for each LTC and share on the HDR UK- CALIBER portal; (ii) estimate the age-, sex- and LTCs and mental health conditions- specific background (pre-long COVID) risks of developing long COVID and deaths, (iii) estimate risks for developing new LTCs and/mental health conditions among long COVID patients.
Using CPRD GOLD and Aurum primary care electronic health records (to determine COVID cases, characteristics and LTCs) linked with HES-APC (to determine COVID cases and LTCs), ONS (to determine all-cause and cause-specific mortality) and COVID datasets (to determine COVID cases), we will study risks of long COVID among people with pre-existing LTCs and mental health conditions.
Our initial study population will be individuals with a positive COVID diagnosis, from which we will assess risk of long COVID and risk factors involved using multivariable logistic regression models.
Among individuals with long COVID we will assess risks of mortality and development of further LTCâs using multivariable Cox regression models.
As part of the STIMULATE-ICP project, we will work with patients, public, researchers, clinicians and policymakers to provide information on long COVID integrated care pathways. This study will help plan and implement LTC care across conditions, and identify the background risks for developing other LTCs / mental health conditions. We will work with policy makers to develop care pathways for managing dual risks of long COVID and other LTCs/ mental health conditions, with benefits for LTCs beyond the COVID-19 pandemic.
Source -
Psychiatric diagnoses and self-harm episodes among children and young people in UK primary care records before and during the COVID-19 pandemic: a population-based cohort study — Pearl Mok ...
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Psychiatric diagnoses and self-harm episodes among children and young people in UK primary care records before and during the COVID-19 pandemic: a population-based cohort study
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-14
Organisations:
Pearl Mok - Chief Investigator - University of Manchester
Pearl Mok - Corresponding Applicant - University of Manchester
Alex Trafford - Collaborator - University of Manchester
Carolyn Chew-Graham - Collaborator - Keele University
Darren Ashcroft - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Shruti Garg - Collaborator - University of ManchesterOutcomes:
⢠Incidence of psychiatric diagnoses: depression (aged 6-24 years), anxiety disorders (aged 6-24 years), eating disorders (aged 10-24 years), attention deficit hyperactivity disorder (ADHD) (aged 1-24 years), autism spectrum disorder (ASD) (aged 1-24 years), psychosis (aged 13-24 years), personality disorders (aged 16-24 years), and substance misuse (aged 16-24 years).
⢠Incidence of self-harm (aged 10-24 years).
⢠Incidence of prescriptions for all psychotropic medications and separately for antidepressants, benzodiazepines, and medications for ADHD (aged 4-24 years).
⢠Incidence of GP referrals to mental health services (aged 10-24 years).
⢠All self-harm episodes (i.e. including first and subsequent recorded episodes).
⢠All prescriptions for antidepressants, benzodiazepines, antipsychotics, and medications for ADHD (i.e. including first and subsequent prescriptions).Since some mental health conditions are rarely diagnosed at a very young age, the exact age of eligibility for inclusion will vary across the array of outcome measures that will be examined, as indicated above.
Description: Technical Summary
The aim of this time series study is to investigate temporal trends in incidence of primary care-recorded psychiatric diagnoses, self-harm episodes, prescription of psychotropic medications, and referral to mental health services among children and young people in the UK before and during the COVID-19 pandemic.
Using data from the CPRD GOLD and Aurum datasets, we will delineate two cohorts of patients aged 1-24 years during 2010 and early 2022. Depending on the age of eligibility, psychiatric diagnoses examined will include depression, anxiety disorders, eating disorders, attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, psychosis, substance misuse, and personality disorders. We will calculate the incidence for each outcome measure for each quarterly (or monthly) period, stratified by age group, gender, and practice-level deprivation quintiles. We will use time series analysis to quantity the changes in temporal trends of the outcome measures, comparing the periods before and after the start of the pandemic. We will use mean-dispersion negative binomial regression models to estimate the expected incidence trends from March 2020 onwards, based on the trends predicted by data from the pre-pandemic period. The âeffectâ of the pandemic will be calculated as the difference between the observed and predicted incidence rates of the outcome measures, had trends that were observed prior to the start of the pandemic continued.
It is anticipated that the enduring adverse impact of the pandemic on children and young peopleâs mental health will become evident in the months and years to come, with a sustained increase in demand for healthcare resources. Working with our patient and public involvement and engagement partners, our findings will help to inform health, social, and educational services when designing mental health recovery plans and to facilitate better targeting of resources to tackle young peopleâs mental health problems.
Source -
The impact of COVID-19 pandemic on health care service provision for patients with newly diagnosed cancer — Alvina Lai ...
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The impact of COVID-19 pandemic on health care service provision for patients with newly diagnosed cancer
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-03-18
Organisations:
Alvina Lai - Chief Investigator - University College London ( UCL )
Alvina Lai - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Wai Chang - Collaborator - University College London ( UCL )
Yen Yi Tan - Collaborator - University College London ( UCL )
Yulei Fan - Collaborator - University College London ( UCL )Outcomes:
GP attendances, hospital in-patient admissions; hospital outpatient admissions; mortality all-cause; mortality cause-specific
Description: Technical Summary
This study aims to evaluate the impact of the pandemic on change in health care service provision for patients with cancer. We aim to retrospectively evaluate previous attendances using the interrupted time series study design. A time series is a continuous sequence of observations within a population over a specific time interval. Focusing on patients with newly diagnosed cancer (incident cancers), we will analyze trends in GP and hospital attendances for cancer patients (counts by month and percentage change year-on-year by month). We will perform interrupted time series analysis of primary care and hospital attendances (weekly counts) by cancer type, number and types of comorbidities, index of multiple deprivation and sex. We will estimate the impact of missed attendances on excess mortality using an instrumented difference-in-differences design, using the COVID-19 pandemic as the instrument. To define the level of the instrumental variable, we will select time periods when a marked decrease in attendances is observed. The relationship between weekly attendances and mortality will be estimated using the least-squares method. This study can help establish the scale of the indirect effects of the pandemic to ascertain the long-term effects of reduced contact with health and care systems. By estimating the unintended harm that may have resulted from the pandemic's response on health care seeking behavior and the provision of health care for non-COVID19 conditions, these findings could help alert policymakers on the importance of ensuring that measures put in place to control COVID-19 will not adversely impact the management of cancer.
Source -
Investigating management of lung nodules, and the impact of pre-diagnostic surveillance on health and economic outcomes. — Imperial College Healthcare NHS Trust...
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Investigating management of lung nodules, and the impact of pre-diagnostic surveillance on health and economic outcomes.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Lung Nodules.
Source -
Extension: Borough Public Health Profiles and JSNA information — Westminster City Council...
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Extension: Borough Public Health Profiles and JSNA information
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: JSNA.
Source -
Characterising clusters of multimorbidity, trajectories and associations with clinical outcomes and healthcare utilisation — Imperial College London...
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Characterising clusters of multimorbidity, trajectories and associations with clinical outcomes and healthcare utilisation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity.
Source - and 6 more projects — click to show
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The incidence of common mental disorders in children and young people
— Imperial College London...
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The incidence of common mental disorders in children and young people
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Mental Disorders .
Source -
Information and Intelligence to inform Maternity Equity and Equality Strategy
— Imperial College London...
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Information and Intelligence to inform Maternity Equity and Equality Strategy
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: health inequalities .
Source -
Getting It Right First Time – Childhood Asthma — NHS England...
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Getting It Right First Time – Childhood Asthma
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: NHS England
Description: Childhood Asthma.
Source -
Extension: Mixed methods evaluation of the impact of the shift to remote consultation in primary and secondary care in London — Imperial College London...
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Extension: Mixed methods evaluation of the impact of the shift to remote consultation in primary and secondary care in London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Remote Consultations.
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Estimating inequalities in burden of illness in patients with Alzheimer’s disease
— Lane Clark & Peacock LLP...
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Estimating inequalities in burden of illness in patients with Alzheimer’s disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Alzheimer’s disease . Commercial
Source -
Impact of Sotrovimab in Treatment of COVID-19
— Imperial College Healthcare NHS Trust...
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Impact of Sotrovimab in Treatment of COVID-19
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Covid-19. Commercial
Source
2022 - 02
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Demographics (Record Level and Aggregate no small number suppression ) (Direct Care and secondary uses ) — NHS England...
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To report vaccine uptake by cohort. This will enable a GP Practice to (1) understand how well they are covering priority groups and (2) drill down into the cohort to identify individuals pending vaccines and send out invites — IG-05210
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 25/02/2022
Purpose for which the data is being used: To report vaccine uptake by cohort. This will enable a GP Practice to (1) understand how well they are covering priority groups and (2) drill down into the cohort to identify individuals pending vaccines and send out invites
Dataset: Demographics
Category of Data: Record Level and Aggregate no small number suppression
Direct Care or Secondary Uses : Direct Care and secondary uses
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: Health and Social Care Act 2012 section 261(4)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 9(2)(g) â substantial public interest, plus Part 2 Sched 1 DPA18, para 6 statutory and governmental purpose GDPR Article 9(2)(h) â healthcare purposes, plus Part 1 Sched 1 DPA18, para 2 health or social care purpose GDPR ARticle 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: Health and Social Care Act 2012 section 261(4)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 9(2)(g) â substantial public interest, plus Part 2 Sched 1 DPA18, para 6 statutory and governmental purpose GDPR Article 9(2)(h) â healthcare purposes, plus Part 1 Sched 1 DPA18, para 2 health or social care purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
National Data Opt-out Applied: Not applied - legal obligation overrides
Source -
NHS Number
School URN (Identifiable) (Secondary Use) — NHS England...
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To provide the NHS number and School URN to NHS England to allow for accurate monitoring, reporting and pandemic planning of the 12-15 cohort and allowing for a breakdown of vaccination administrations by school. — IG-04539_1
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 11/02/2022
Purpose for which the data is being used: To provide the NHS number and School URN to NHS England to allow for accurate monitoring, reporting and pandemic planning of the 12-15 cohort and allowing for a breakdown of vaccination administrations by school.
Dataset: NHS Number School URN
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Use
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 9(2)(g) â substantial public interest GDPR Article 9(2)(h) â healthcare purposes health or social care purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1 DPA 2018, Part 2 Sched 1, para 6 statutory and governmental purpose DPA 2018 Part 1 Sched 1 , para 2 health or social care purpose DPA 2018 Part1, Sched 1 para 3 public health
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 6(1)(e) â public task Processing by Recipient GDPR Article 9(2)(g) â substantial public interes 9(2)(h) â healthcare purposes 9(2)(i) â public health purposes DPA 2018 Part 2 Sched 1, para 6 statutory and governmental purpose DPA 2018 Part 1 Sched 1 , para 2 health or social care purpose DPA 2018 Part1, Sched 1 para 3 public health
National Data Opt-out Applied: Not applied - legal obligation overrides
Source -
Shielded Patient List (SPL) (Aggregate (small numbers not supressed)) (Secondary Uses ) — NHS England & Improvement...
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To build an AV (anti-viral) & nMAB (neutralising monoclonal antibodies) management reporting tool which provides comprehensive oversight of targeted Covid Therapeutics deployment for national, regional, and local systems and Covid Medicines Delivery Units (CMDUs) — IG-00497_6
Recipient Data Controller Organisation(s) : NHS England & Improvement
Approval Date: 02/02/2022
Purpose for which the data is being used: To build an AV (anti-viral) & nMAB (neutralising monoclonal antibodies) management reporting tool which provides comprehensive oversight of targeted Covid Therapeutics deployment for national, regional, and local systems and Covid Medicines Delivery Units (CMDUs)
Dataset: Shielded Patient List (SPL)
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 9(2)(g) â substantial public interest, plus Part 2 Sched 1 DPA18, para 6 statutory and governmental purpose re COPI
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation â by virtue of COPI Notice/Direction GDPR Article 9(2)(h) â healthcare purposes, plus Part 1 Sched 1 DPA18, para 2 health or social care purpose
National Data Opt-out Applied: Not applied - legal obligation overrides
Source -
How the predictions of algorithms used in healthcare provision change: an investigation using COVID-19 and Cardiovascular disease risk prediction case studies. — Mike Lonergan ...
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How the predictions of algorithms used in healthcare provision change: an investigation using COVID-19 and Cardiovascular disease risk prediction case studies.
Datasets:GP data, Practice Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-02-01
Organisations:
Mike Lonergan - Chief Investigator - CPRD
Mike Lonergan - Corresponding Applicant - CPRD
Allan Tucker - Collaborator - Brunel University
Puja Myles - Collaborator - CPRD
Ylenia Rotalinti - Collaborator - Brunel UniversityOutcomes:
Positive COVID test result; cardiovascular event (stroke/heart attack);hospitalisation/death.
Description: Technical Summary
Artificial Intelligence (AI) and Machine Learning (ML) techniques can find and interpret patterns in data that people find difficult to reliably detect. They are starting to be applied to medical systems. A major advantage of these approaches is their ability to learn, updating their estimates in response to new information. However, that flexibility also poses a problem for regulation as it is important to ensure that any changes do not change the benefit-risk ratio in a way that poses risks to patient safety.
This project is applying AI techniques to subsets of CPRD Aurum primary care data in order to estimate risks associated with COVID and cardiovascular disease (CVD). It will fit models to initial datasets, then refit the models after adding a block of more recent data. The situation around COVID has changed rapidly, while that for CVD is likely to be more stable, so these represent two different scenarios of interest. Four types of models (Logistic Regression, Bayesian networks, Neural networks, and Random Forest tree-based models) will be investigated. Changes in how well the models fit the data, the models' internal structure, their parameter estimates and associated uncertainties, and their predictions will be examined. The aim is to understand the relative stability and informativeness of each of these measures, in order to develop methodology to determine if there has been a significant change in the way that an algorithm is working to inform regulators of the need for re-assessment.
This work will benefit patients, including NHS patients in England and Wales, by informing the development of regulatory standards for AI algorithms used in diagnostic systems and other medical devices, particularly in the area of Adaptive AI software programmes which can learn and change as they receive new information.
Source -
Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe — Saad Shakir ...
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Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-02-21
Organisations:
Saad Shakir - Chief Investigator - Drug Safety Research Unit
Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Hai Nguyen - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research UnitOutcomes:
The outcomes to be measured include a list of AESIs, which are drawn from the ACCESS project (http://www.encepp.eu/phact_links.shtml) or other published sources (http://www.encepp.eu). The AESIs are conditions primarily based on those defined by the Safety Platform for Emergency vACcines (SPEAC) and endorsed for COVID-19 vaccine safety assessment by the WHO Global Advisory Committee for Vaccine Safety, by the EMA, and by the US CDC. For most of the AESI, the Brighton Collaboration (2010) case definitions are available. The AESIs to be analysed in this study are:
Auto-immune diseases to include: Guillain-Barré Syndrome (GBS); Acute disseminated encephalomyelitis (ADEM); Narcolepsy; Acute aseptic arthritis; Diabetes type 1; (Idiopathic) Thrombocytopenia. Cardiovascular system outcomes to include: Microangiopathy; Heart failure; Stress-induced cardiomyopathy; Coronary artery disease;
Arrhythmia; Myocarditis; Pericarditis; Cerebrovascular disease. Circulatory system outcomes to include: Deep vein thrombosis (DVT); Pulmonary embolism (PE); Single Organ Cutaneous Vasculitis; Cerebral venous sinus thrombosis (CVST); Splanchnic vein thrombosis (SVT); Coagulation disorders; Disseminated intravascular coagulation (DIC); Kawasaki disease. Hepato-gastrointestinal and renal system outcomes to include:
Acute liver injury; Acute kidney injury. Nerves and central nervous system outcomes to include: Generalised convulsions; Encephalitis/meningoencephalitis; Transverse myelitis; Bellâs palsy. Respiratory system outcomes to include: Acute respiratory distress syndrome (ARDS). Skin and mucous membrane, bone and joints system outcomes to include: Erythema multiforme; Chilblain â like lesions. Other systems outcomes to include: Anosmia, ageusia; Anaphylaxis; Multisystem inflammatory syndrome in children; Multisystem inflammatory syndrome in adults; Vaccine-associated enhanced COVID-19 disease (VAED) or vaccine associated enhanced respiratory COVID-19 disease (VAERD) (if measurable in the participating databases); Vaccine-induced immune thrombotic thrombocytopenia (VITT); Sudden death; Death of any cause.First in period (possible recurrent) events will be assessed and case definition algorithms will be based on codes for diagnoses, procedures, and treatments. Definitions, codes and proposed algorithms for the AESI have been published and the definitions have been used for estimation of pre-pandemic population background rates. These definitions will be reviewed and refined prior to the analysis based on expert input. The refinements may include specifications regarding the code types (procedure/diagnosis/drug), setting (inpatient/outpatient/emergency), and/or sector (primary/secondary). For the self-controlled analysis, definition of an AESI will include the length of the âclean windowâ and lengths of the risk interval, as well as the lengths of the pre-vaccination and post-vaccination control intervals. Lengths of the risk intervals will be guided by previous literature on the specific AESI, biological plausibility, and the evidence from the signal detection phase of the time-periods after vaccination with the highest SMRs. For instance, for events of anaphylaxis, which are expected to have rapid onset after vaccination, we will likely propose the risk interval 0-2 days. The approach described in the published US PASS [1] will be used as the starting point and subsequently adapted to the EU setting. However, there is an inherent uncertainty about the true length of most risk intervals, which will be addressed by applying sensitivity analyses.
AESIs other than those listed above may be considered if relevant signals appear during the study conduct or if additional AESI become added to the ACCESS protocol or SPEAC.
Description: Technical Summary
The novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2) causes coronavirus disease-2019 (COVID-19) and has caused a global pandemic. The mRNA-1273 vaccine, developed by Moderna, Inc., and the US National Institute of Allergy and Infectious Diseases, combines mRNA delivery platform with the SARS-CoV-2 spike immunogen. The Spikevax vaccine was authorised across the EU to prevent COVID-19 in individuals aged 12 years and older.
This post-authorisation active surveillance safety study will monitor and assess the real-world safety of Spikevax using UK primary care data (CPRD Aurum) and linked datasets (HES, ONS death registration, COVID-19 datasets). The study aims to conduct signal detection followed, if necessary, by safety evaluation of identified possible signals.
Signal detection will use a cohort design and historical background rates of the AESIâs before the COVID-19 pandemic (2017-2019) will be used as expected rates in the unvaccinated. Incidence rates among Spikevax vaccinees will be compared against appropriate general population background AESI rates.
Signal evaluation will use either a self-controlled or parallel cohort design. Self-controlled designs are suitable for events with acute onset, short induction/latency, and a well-defined risk period, and where difficult to identify a suitable comparator or measure confounding. For AESIâs where these conditions are not fulfilled, cohort design will be used.
For the self-controlled designs, the incidence rate ratio between the risk and the control period will be computed using conditional Poisson regression. For parallel cohort designs, appropriate contrasts will be estimated in exposed vs. unexposed, while controlling for confounding.
The study includes three planned data extraction timepoints (January 2022, June 2022, March 2023); with repeat analyses conducted at each timepoint. Aggregate results from this UK study will be pooled with results generated by other Data Access Providers. The overall study is planned as analysis of routinely collected health data including the UK, Denmark, Italy, Norway, Spain.
Source -
The Incidence of Common Autoimmune Diseases in People with COVID-19: a Retrospective Cohort Study using the Clinical Practice Research Datalink. — Anuradhaa Subramanian ...
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The Incidence of Common Autoimmune Diseases in People with COVID-19: a Retrospective Cohort Study using the Clinical Practice Research Datalink.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-02-24
Organisations:
Anuradhaa Subramanian - Chief Investigator - University of Birmingham
Umer Syed - Corresponding Applicant - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Shamil Haroon - Collaborator - University of BirminghamOutcomes:
A composite measure of the incidence of any of the following autoimmune diseases during the study follow-up period: type 1 diabetes mellitus (T1DM), myasthenia gravis, autoimmune thyroiditis, systemic lupus erythematosus (SLE), Sjogrenâs syndrome, vitiligo, rheumatoid arthritis (RA), psoriasis, pernicious anaemia, inflammatory bowel disease (IBD) and celiac disease.
The individual incidence of the aforementioned autoimmune diseases during the study time periodDescription: Technical Summary
The primary aim is to investigate if an association exists between COVID-19 and the risk of developing common autoimmune diseases. A secondary aim is to assess which autoimmune diseases (AID) has the strongest association with COVID-19. This is due to case-reports where patients with a COVID-19 diagnosis have developed AID, however, thus far no large-scale retrospective cohort study has assessed this on a population level. (1, 2)
A retrospective cohort study will be conducted from January 31st 2020 to June 30th 2021. Participants will be selected from primary care data using clinical (SNOMED-CT) codes. All eligible participants with a positive reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will form the exposed group for the primary analysis. This group will be compared to matched controls with regards to the development of selected AID.
The primary outcome will consist of a composite measure of the incidence of common AID in the exposed group compared to the unexposed. The secondary outcome will be the incidence rates of individual AID.For the primary analysis, the crude incidence rates for the primary and secondary outcomes will be calculated for the exposed and unexposed groups. Further analysis will be done using a Cox proportional hazards models to estimate the adjusted hazard ratio for the outcomes between the two groups. Participants will be matched on relevant covariates during extraction and analysis.
The sensitivity analysis will include both confirmed and âsuspectedâ COVID-19 diagnosis as the âexposedâ group. Subgroup analyses will be stratified by sex, age, and ethnic groups
This study may demonstrate that the persistent sequalae of COVID-19 are due to an autoimmune reaction. This allows further trials centred around the implementation of AID treatments for patients suffering from long COVID. Thus, aiding the reduction of long COVID disease burden and improving patient quality of life.
Source -
Extension: Volunteering Programme Evaluation – NWL ICS — ICHP...
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Extension: Volunteering Programme Evaluation – NWL ICS
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Volunteering Programme Evaluation .
Source -
Evaluation of clinical parameters following COVID-19 infection in pregnancy (COpregVID) — Chelsea and Westminster Hospital NHS Foundation Trust...
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Evaluation of clinical parameters following COVID-19 infection in pregnancy (COpregVID)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-22
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Covid in pregnancy.
Source -
Extension: FARSITE — ICHP...
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Extension: FARSITE
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Feasibility Services.
Source -
Enabling regional, rapid acute admissions data flows to support vaccine safety and vaccine effectiveness research — Imperial College Healthcare NHS Trust...
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Enabling regional, rapid acute admissions data flows to support vaccine safety and vaccine effectiveness research
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Covid Vaccine.
Source - and 2 more projects — click to show
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Westminster Planning Model — Westminster City Council...
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Westminster Planning Model
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-22
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Westminster.
Source -
Extension: Utilisation of real-world evidence in profiling the efficacy and safety for Ustekinumab (Stelara) in treating IBD patients in North West London — ICHP...
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Extension: Utilisation of real-world evidence in profiling the efficacy and safety for Ustekinumab (Stelara) in treating IBD patients in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: IBD. Commercial
Source
2022 - 01
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Impact of the coronavirus disease (COVID-19) pandemic on incidence of tics in children and young people: a population-based cohort study — Chris Hollis ...
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Impact of the coronavirus disease (COVID-19) pandemic on incidence of tics in children and young people: a population-based cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-01-05
Organisations:
Chris Hollis - Chief Investigator - University of Nottingham
Rebecca Joseph - Corresponding Applicant - University of Nottingham
Carol Coupland - Collaborator - University of Nottingham
Charlotte Hall - Collaborator - University of Nottingham
Ruth Jack - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Incidence of tics
Description: Technical Summary
The study aims to describe and compare the incidence of tics in children and young people in primary care before and during the coronavirus (COVID-19) pandemic. Monthly incidence rates of tics before (2015-2019) and during (2020, 2021) the pandemic will be calculated, stratified by age group (4-11 years, 12-18 years) and sex. The characteristics of children and young people with a first tic record in three time periods (2015-2019, 2020, and 2021) will be presented. Monthly incidence rates will be compared according to study period to assess whether the monthly rates were altered during the pandemic.
The study population will include people in CPRD Aurum aged 4-18 years in England with eligible follow-up and a first tic record during the period 01 January 2015 to 31 December 2021. To assess incidence, everyone in the study will need at least one year of practice registration before their first tic record.
The outcome is a first tic record during the study window. Monthly incidence rates will be calculated using the CPRD Aurum denominator data and presented according to age group and sex.
Demographic characteristics (age, sex, ethnicity, deprivation score, practice region) and comorbidities (autism spectrum disorders, attention deficit hyperactivity disorder, self-harm, eating disorders, obsessive compulsive disorder, anxiety, and depression) will be described according to study period of first tic record.
The monthly incidence rates of tics will be compared using Poisson or negative binomial regression, as appropriate. Interactions with study period, age group, and sex will be included in the models to test whether the monthly incidence rate for subgroups was altered during the pandemic years (2020, 2021) compared to pre-pandemic (2015-2019).
The study will help identify areas for future service development and will help healthcare professionals understand who may be most vulnerable to developing tics in response to significant environmental stressors.
Source -
An observational retrospective cohort study describing clinical outcomes and utilisation of healthcare resources among persons with COVID-19 in England, stratified by infection severity and selected comorbidities — Sabada Dube ...
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An observational retrospective cohort study describing clinical outcomes and utilisation of healthcare resources among persons with COVID-19 in England, stratified by infection severity and selected comorbidities
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2022-01-27
Organisations:
Sabada Dube - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Sophie Graham - Corresponding Applicant - Evidera, Inc
Clement Erhard - Collaborator - Astra Zeneca Ltd - UK Headquarters
Eleni Rapsomaniki - Collaborator - Astra Zeneca Ltd - UK Headquarters
Kathryn Evans - Collaborator - Evidera, Inc
Nahila Justo - Collaborator - Evidera Ltd - UK
Renata Yokota - Collaborator - Astra Zeneca Ltd - UK Headquarters
Sabada Dube - Collaborator - Astra Zeneca Ltd - UK Headquarters
Sofie Arnetorp - Collaborator - Astra Zeneca R&D Molndal Sweden
Sylvia Taylor - Collaborator - Astra Zeneca Ltd - UK Headquarters
Xiaojian Chen - Collaborator - Astra Zeneca Inc - USA
Yi Lu - Collaborator - Evidera, IncOutcomes:
⢠Size of the population: the size of the populations that are ineligible for COVID-19 vaccinations or at increased risk of COVID-19 infections following vaccination.
⢠COVID-19 infections: new COVID-19 infections.
⢠Long COVID-19: patients who have developed long COVID-19. .
⢠Health care resource use and associated costs: inpatient visits, hospital length of stay, days mechanically ventilated, days in intensive care, outpatient visits, specialist outpatient visits, primary care visits, primary care referrals, prescriptions, procedures and direct cost of care associated with COVID-19 infections.Description: Technical Summary
This is a retrospective cohort study describing clinical outcomes and utilization of healthcare
resources and associated costs among persons with COVID-19 using Clinical Practice Research Datalink (CPRD) Aurum linked to HES, CHESS, SACT) and ONS deaths data.
Objective 1 of this study is to estimate the size of populations (n, %) in England who
potentially are ineligible for vaccine or are at risk of COVID-19 infection following vaccination. The study population for objective 1 will include all pre-defined patient subgroups considered to be potentially ineligible for COVID-19 vaccines or are at risk of COVID-19 infection following vaccination, due to contraindications, limited safety data available, and/or elevated risk of suboptimal response. The second objective is to estimate incidence of COVID-19, by age group, disease severity, and selected comorbidities. This will be measured by calculating infections per 100 person-months and 95% confidence intervals. The third objective is to estimate incidence of long COVID-19 syndrome, by age, disease severity, and selected comorbidities. This will be measured by proportion of patients (n, %) with long COVID-19 syndrome as well as by infections per 100 person-months and 95% confidence intervals. The fourth objective is to describe patterns of HCRU and cost associated with COVID -19 infection, stratified by age, selected comorbidities, disease severity and the occurrence (vs. absence) of long COVID-19 syndrome.
This study is expected to benefit the public health of England by providing an updated estimate on the incidence of COVID-19 and long COVID-19 for vulnerable patient groups, associated healthcare resource utilization, and direct medical costs. This will also provide essential information for cost-effectiveness assessment needed by health technology assessment agencies in the UK and other countries to decide whether or not additional therapeutics are needed and should be approved for prevention and treatment of COVID-19.
Source -
Study to evaluate the healthcare needs of unpaid carers and looked after children — ICHP...
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Study to evaluate the healthcare needs of unpaid carers and looked after children
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Health Inequalities. Commerical
Source -
Heart Failure Pathway Transformation: Health Economic Analysis. — Imperial College Healthcare NHS Trust...
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Heart Failure Pathway Transformation: Health Economic Analysis.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-22
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart Failure. Commercial
Source -
Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease — Lane Clark & Peacock LLP...
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Extension: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-22
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: CVD. Commerical
Source -
Characterising and preventing multimorbidity in NW London with linkage to the LOLIPOP cohort — Imperial College London...
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Characterising and preventing multimorbidity in NW London with linkage to the LOLIPOP cohort
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-22
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity in NWL South Asian population .
Source -
Extension: NWL ICS Population health Management and Inequalities CORE20PLUS5 research — ICHP...
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Extension: NWL ICS Population health Management and Inequalities CORE20PLUS5 research
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-22
Opt Outs: no information provided./p>
Organisations: ICHP
Description: Population Health Management.
Source
2021 - 12
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ADR UK Research Fellows: Ministry of Justice and the Department for Education linked datasets fellowships — unknown...
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ADR UK Research Fellows: Ministry of Justice and the Department for Education linked datasets fellowships
Where: unstated
When: 2021-12-16
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding five 12-month research fellowships to conduct analysis using the Ministry of Justice (MoJ)-Department for Education (DfE) linked dataset to understand links between childhood characteristics, educational outcomes, and offending.
This is the second funding call to be launched as part of the ADR UK Research Fellowships scheme, following the Data First magistratesâ and Crown Court fellowship.
Find out more about the Research Fellows and their projects below.
Source -
ADR UK Research Fellows: Ministry of Justice and the Department for Education linked datasets fellowships — unknown...
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ADR UK Research Fellows: Ministry of Justice and the Department for Education linked datasets fellowships
Where: unstated
When: 2021-12-16
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding five 12-month research fellowships to conduct analysis using the Ministry of Justice (MoJ)-Department for Education (DfE) linked dataset to understand links between childhood characteristics, educational outcomes, and offending.
This is the second funding call to be launched as part of the ADR UK Research Fellowships scheme, following the Data First magistratesâ and Crown Court fellowship.
Find out more about the Research Fellows and their projects below.
Source -
Vaccination
Demographic (Identifiable) (Direct Care) — NHS England / Improvement...
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For contact to be made with individuals whose Coronavirus vaccination appointment have been cancelled. — IG-02466
Recipient Data Controller Organisation(s) : NHS England / Improvement
Approval Date: 04/12/2021
Purpose for which the data is being used: For contact to be made with individuals whose Coronavirus vaccination appointment have been cancelled.
Dataset: Vaccination Demographic
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes GDPR Article 9(2)(i) â Public health DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes DPA 2018 Part 1 Schedule 1 para 3 â Public health
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes GDPR Article 9(2)(i) â Public health DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Healthcare database study to estimate prevalence and healthcare burden of prurigo nodularis — Ellen Hubbuck ...
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Healthcare database study to estimate prevalence and healthcare burden of prurigo nodularis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-17
Organisations:
Ellen Hubbuck - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Seán Conlon - Collaborator - SANOFIOutcomes:
Prevalence; Incidence.
Prior comorbidities
Hay fever; Peanut allergy; Atopic dermatitis; Chronic rhinosinusitis with nasal polyps (CRSwNP); Chronic rhinosinusitis without nasal polyposis (CRSwNP); Asthma; Chronic spontaneous urticaria; Eosinophilic oesophagitis; Chronic Obstructive Pulmonary Disease (COPD); Bullous pemphigoid; Liver disease/liver dysfunction; HIV.
Healthcare resource use
Patient follow-up; GP visits; Inpatient admissions; Inpatient length of stay; Outpatient visits; Accident & Emergency visits; GP costs; Inpatient costs; Outpatient costs; Accident & Emergency costs.
Treatment pathways
Primary care prescriptions for:
Topical Corticosteroids; Topical Calcineurin Inhibitors; Tricyclic antidepressants; Intralesional Corticosteroids; UV therapy; First generation H1 antihistamine; Second generation H1 antihistamine; Systemic Corticosteroids (oral and injectable route only); Gabapentinoids; Immunosuppressants.
Description: Technical Summary
A non-interventional, retrospective cohort study to calculate the incidence and prevalence of prurigo nodularis (PN). Prevalence and incidence will be calculated for patients with a Read code, SNOMED or ICD-10 code for PN from a population of research quality patients in CPRD linked to secondary care data. Patients with moderate to severe PN will be defined as having a prescription for systemic immunosuppressants or neuromodulating drugs following a PN diagnosis.
The study aims to understand the healthcare resource use associated with incident PN (primary cohort) and patients with moderate to severe PN (secondary cohort). â¯Patients with moderate to severe PN will be matched 1:1 to theâ¯patients withâ¯mildâ¯PN,â¯matching for age and gender.
Healthcare resource use will be calculated for both the un-matched cohorts (primary and secondary cohorts) and the matched moderate to severe vs. mild PNâ¯cohorts.â¯Analysis will be restricted to eligible patients registered with English practices that participate in the CPRD linkage scheme. Patients will be required to have aâ¯180-dayâ¯wash-in period from their start of registration period and index date. Patients will also be required to have a minimum ofâ¯1-yearâ¯follow-up, with the exclusion of death.â¯â¯
Contacts would be summarised as rates per patient year (number of contacts/total follow-up period) as would costs (total cost/total follow-up period).⯠Generalized linear model (GLM)â¯with aâ¯Poissonâ¯distribution will be used to model contact/admissions as the dependent variable with an offset of follow-up, with PN/matched control as a variable along with other variables of interest. Negative binomial/Gamma distributions will be used for costs.
Drugs prescribed in primary care will be summarizedâ¯for both pre- and post-indexâ¯date.â¯The proportion of patients that have received therapies will be summarised.â¯â¯
Source -
Assessing the risk of systemic diseases, such as Behcet's, systemic lupus erythematous and inflammatory bowel disease, in children that present to primary care with mouth ulcers. — Michael Beresford ...
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Assessing the risk of systemic diseases, such as Behcet's, systemic lupus erythematous and inflammatory bowel disease, in children that present to primary care with mouth ulcers.
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-17
Organisations:
Michael Beresford - Chief Investigator - University of Liverpool
Natasha Goss - Corresponding Applicant - University of Liverpool
Clare Pain - Collaborator - Alder Hey Childrenâs NHS Foundation Trust
Kate Fleming - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
Systemic diseases: Behcetâs disease, systemic lupus erythematous (SLE) and/or inflammatory bowel disease (IBD).
Description: Technical Summary
There are approximately 8.89 million children under the age of 18 years in the UK. With a prevalence of 5-10%, about 0.67 million of them experience recurrent mouth ulcers. Due to variance in health seeking behaviours this is likely an underestimation, especially in terms of transient ulceration.
Evidence suggests that mouth ulcers may not only act as a symptom of certain immune-mediated conditions but can be a presenting complaint months or years before diagnosis. The specific immune-mediated conditions of interested are Behcetâs disease, systemic lupus erythematous (SLE) and inflammatory bowel disease (IBD).
This study will extract data on a sample of children aged under 16 years from the Clinical Practice Research Datalink (CPRD). The database will be used to investigate: (1) the risk of systemic disease in children who present to primary care with mouth ulcers; and (2) the initial presentation characteristics, focussing on mouth ulcers, of children who have been diagnosed with a systemic disease.
Incidence and odds ratios will be calculated to determine the risk associated with mouth ulcers in relation to systemic disease. Multifactor analysis will be used to determine if these risks are associated with other factors such as sex, age, deprivation, or other presentation characteristics. Linked IMD data will be utilised to detect potential differences in outcomes between socioeconomic groups, hence informing clinical practice to reduce healthcare inequalities in the long term. The combination of 2 study designs will allow conclusions to be drawn about the incidence of systemic diseases presenting as mouth ulcers and the outcome risks associated with the presentation.
Source -
The epidemiology of diseases of the circulatory system in the United Kingdom and the healthcare care cost and resource use associated with managing these conditions — ...
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The epidemiology of diseases of the circulatory system in the United Kingdom and the healthcare care cost and resource use associated with managing these conditions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-10
Organisations:
- Chief Investigator -
- Corresponding Applicant -
- Collaborator -
Cerys Jenkins - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Chris Shepherd - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Darren Summers - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
James Bateman - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Rhiannon Thomason - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient characteristics; Comorbidities; Healthcare resource use; Healthcare costs; All-cause mortality; Incidence; Prevalence
Description: Technical Summary
Our aim is to determine the descriptive epidemiology of diseases involving the circulatory system and estimate and cost healthcare use by people with these conditions. Acceptable patients will be selected from CPRD GOLD and Aurum if they have a medical code indicative of a disease of the circulatory system. For sensitivity analyses, a subcohort will comprise English patients eligible for linkage to the HES admitted patient care (APC) and outpatient datasets, and their Office for National Statistics (ONS) death registration data. The start of CPRD follow-up will be defined as the later of the patientâs registration date and, in CPRD GOLD, their practiceâs up-to-standard date; the end of CPRD data follow-up will be defined as the earliest of the patientâs transfer-out date, date of death (if applicable), and the last data-collection date for their practice. The presentation date will be defined as that of the patientâs first ever record with a code indicative of the circulatory disease. For incident patients, selected if their presentation date occurs at least 90 days after registration, detailed patient characteristics will be determined. Time to death will be presented using KaplanâMeier analysis. Healthcare resource use and associated costs will be estimated before and after presentation and comprise primary care contacts, primary care prescriptions, outpatient attendances and hospital admissions. Quintiles of deprivation score (Practice Level Index of Multiple Deprivation) will be described. Incidence and point prevalence will be calculated on a yearly basis.
This study will provide valuable information on the healthcare burden associated with diseases of the circulatory system and help to inform healthcare decision-making.
Source -
Drug Utilization and Safety of Glycopyrronium in children who have excess salivation — Yoon Loke ...
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Drug Utilization and Safety of Glycopyrronium in children who have excess salivation
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-06
Organisations:
Yoon Loke - Chief Investigator - University of East Anglia
Yoon Loke - Corresponding Applicant - University of East Anglia
Kathryn Richardson - Collaborator - University of East AngliaOutcomes:
1. Number of users of glycopyrronium, and proximal and distal diagnostic codes associated with the prescription. In particular, we will count the numbers of those with a sialorrhea diagnostic code, and codes for underlying chronic neurological disorders.
2. Incident or treatment-emergent adverse events in major organ systems for children who have been prescribed glycopyrronium for sialorrhoea.Description: Technical Summary
This is a retrospective cohort study that aims to generate supporting information for regulatory consideration.
According to the Drugs and Therapeutics Bulletin, glycopyrronium has been used for many years on an off-label basis for treatment of drooling or sialorrhoea. However, when considering licensing applications, the regulatory authorities require evidence of well-established medical use of at least 10 years (for the specific indication with recognised efficacy and acceptable safety). This study aims to provide evidence on the use of glycopyrronium in symptomatic treatment of severe sialorrhoea (chronic drooling) in children and adolescents with chronic neurological disorder) and the level of safety of glycopyrronium.
We will conduct a descriptive study of drug utilisation, and incidence of treatment-emergent adverse events. This will consist of CPRD participants age below 18 years, and the date of their first prescription of glycopyrronium from 1st January 2006 onwards.
We will follow-up patients who have been treated with glycopyrronium with an accompanying diagnostic code for sialorrhoea, excessive salivation, or drooling. We will measure:
1. Number of users of glycopyrronium, and proximal and distal diagnostic codes associated with the prescription. In particular, we will count the numbers of those with a sialorrhea diagnostic code, and codes for underlying chronic neurological disorders.
2. Incidence of adverse events, classified according to major organ systems. For each particular adverse effect, we will only consider incident or treatment-emergent adverse events, i.e. in people who do not have a past diagnostic code for the adverse event.We will estimate incidence based on follow-up time and report adverse events per 100 patient years. Follow-up time will be based on date of first prescription until 30 days after the last recorded prescription or patient transferred out of practice, whichever is earlier.
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An assessment of effectiveness outcomes in patients with Chronic Obstructive Pulmonary Disease switching from multiple to single inhaler triple therapy in a real-world UK population — Kieran Rothnie ...
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An assessment of effectiveness outcomes in patients with Chronic Obstructive Pulmonary Disease switching from multiple to single inhaler triple therapy in a real-world UK population
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-03
Organisations:
Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Lucinda Camidge - Collaborator - Adelphi Real World
Monica Seif - Collaborator - Adelphi Real World
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real WorldOutcomes:
Proportion of patients with one or more AECOPDs (moderate-to-severe, moderate, severe); rate of AECOPDs (moderate-to-severe, moderate, severe); HCRU (all-cause and COPD-related); Direct medical costs (all-cause and COPD-related).
Description: Technical Summary
Aim: To assess the impact of single inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiation on the rate of acute exacerbations of chronic obstructive pulmonary disease (AECOPDs), all cause and COPD-related healthcare resource utilisation (HCRU) and direct medical costs following a switch from MITT, in a General Practice cohort in England.
Objectives: To compare i) proportion of patients with one or more AECOPDs; ii) the rate of AECOPDs and iii) all cause and COPD related HCRU and direct medical costs among COPD patients prior to and following a switch from MITT to single inhaler FF/UMEC/VI. Rate of moderate-to-severe AECOPDs will also be evaluated in patients with one or more moderate-to-severe AECOPD whilst on MITT prior to treatment switch. HCRU and direct medical costs will also be evaluated in patients with and without AECOPD whilst on MITT prior to treatment switch.
Primary exposure: Single inhaler FF/UMEC/VI initiation following MITT therapy.
Outcomes: Proportion of patients with â¥1 AECOPDs (moderate-to-severe; moderate; severe); rate of AECOPDs (moderate-to-severe; moderate; severe); HCRU; Direct medical costs
Methods: A retrospective cohort, pre-post study design will be implemented to assess clinical effectiveness in COPD patients switching from MITT to single inhaler FF/UEC/VI using linked CPRD Aurum and Hospital Episode Statistics (HES) data. The first/earliest date of single inhaler FF/UMEC/VI prescription between 15th November 2017 and 30th September 2019 will determine the index date. At least 6 months continual MITT use prior to treatment switch and at least 6 months continual FF/UMEC/VI use post switching is required for the primary analysis.
Data analysis: Bivariate comparisons of outcomes will be performed with appropriate tests (e.g., McNemar tests for categorical variables; paired t-tests for continuous variables) based on the distribution of the outcome measure. Rate of AECOPDs and HCRU (events per person-year) will be analysed using rate ratios (RRs) and accompanying 95% robust confidence intervals.
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Maternal Diabetes and risk of neurodevelopmental disorders in the offspring — Kenneth Man ...
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Maternal Diabetes and risk of neurodevelopmental disorders in the offspring
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-02
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Kenneth Man - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - UCL School Of Pharmacy
Li Wei - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )Outcomes:
Neurodevelopmental disorders including Attention deficit hyperactivity disorder (ADHD); autism spectrum disorder (ASD); and seizure/epilepsy in children.
Description: Technical Summary
We will conduct a population-based cohort study including women aged 15 to 45 with a recorded pregnancy in the CPRD Mother Baby Link between January 1, 1990 to December 31, 2020 with GDM or PGDM, defined by 1) having a diagnosis of GDM or PGDM, or 2) having a prescription record of antidiabetic medications before pregnancy starts for PGDM and during pregnancy only for GDM, or 3) having a record of HbA1c â¥48mmol/mol (â¥6.5 %) or fasting plasma glucose concentration â¥7.0 mmol/L or 2h plasma glucose â¥11.1mmol/L before pregnancy for PGDM and fasting plasma glucose concentration â¥5.1mmol/L or 2h plasma glucose â¥8.5mmol/L during pregnancy only for GDM, based on the type of test performed. Other information related to pregnancy will be extracted from Pregnancy Registry. Our objective will be to compare the rate of neurodevelopmental disorders, including ADHD, ASD, and non-febrile seizure/epilepsy, in children whose mothers with MDM to those without MDM. The associations between the pharmacological treatments used to treat MDM, glycemic control and the risk of neurodevelopmental disorders in the offspring will be evaluated. All the diagnosis and outcome information will be identified from the CPRD GOLD primary care data, HES Admitted Patient Care and ONS Death Registration Data. In our analysis, we will use the Cox proportional hazard regression models to estimate the hazard ratios and the K-means longitudinal (Kml) modeling. The propensity score (PS) model will be applied to address differences between treated and untreated groups, and sibling-matched analyses will be conducted to control for shared genetic and social confounding.
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The association between medicines and vaccines commonly prescribed to older people and bullous pemphigoid: a UK population-based study — Sonia Gran ...
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The association between medicines and vaccines commonly prescribed to older people and bullous pemphigoid: a UK population-based study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-14
Organisations:
Sonia Gran - Chief Investigator - University of Nottingham
Sonia Gran - Corresponding Applicant - University of Nottingham
Carron Layfield - Collaborator - University of Nottingham
Christos Chalitsios - Collaborator - University of Nottingham
Grazziela Figueredo - Collaborator - Nottingham University Hospitals
KAREN HARMAN - Collaborator - University of Nottingham
Mikolaj Swiderski - Collaborator - University of Nottingham
Roger Knaggs - Collaborator - University of Nottingham
Rowan Harwood - Collaborator - University of Nottingham
Vibhore Prasad - Collaborator - King's College London (KCL)
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Incident cases of BP (age â¥18 years) identified in primary care. We will include all age-groups as drug induced BP may occur at a younger age than spontaneous BP.
Description: Technical Summary
The aim of the project is to determine whether medicines/vaccines, that are prescribed for common conditions in older people, are associated with BP in the UK population.
Study objectives:
i. To determine the adjusted odds ratio of developing BP per therapeutic group and per class, and for multiple exposure (i.e. the use of more than one therapeutic group of medicine or vaccine during the observation period)), for medicines and vaccines commonly prescribed to older people in the UK population.
ii. To determine which of the above are less associated with an increased risk of BP, suggesting alternative treatment options.
iii. To determine additional medicines associated with BP by using machine learning.
iv. To determine associations between combinations of medicines and BP by using machine
learning.
v. To describe patient characteristics of those at risk of BP, following medicine use, by using machine
learning.Exposure: At least one prescription for antibacterial medicine, medicine for the cardiovascular system, stroke, diabetes, dementia and influenza vaccine; within one year prior to BP or pseudo-diagnosis. We will define âtherapeutic groupsâ by the pathology they treat e.g. cardiovascular, and âclassesâ by mode or mechanism of action e.g. loop diuretic. We will determine âclassesâ within each âtherapeutic groupâ that are not associated with an increased risk of BP, giving clinicians/prescribers alternative treatment options in drug-triggered cases.
Outcome:BP
Study design: Nested case-control
Analysis:
Workstream 1: Descriptive statistics to describe cases and controls. Univariable and multivariable conditional logistic regression adjusted for a priori confounders to assess the association between each therapeutic group/class and vaccine use and BP.Workstream 2: Exploratory association rule mining to identify individual and combinations of medicines prescribed prior to BP. Unsupervised machine learning cluster analysis to identify groups of patients with particular demographic and clinical characteristics and their associations with prescribed medicines linked to BP.
Source - and 30 more projects — click to show
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Trends of second-line antidiabetic treatments in adults with type 2 diabetes — Samy Suissa ...
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Trends of second-line antidiabetic treatments in adults with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Devin Abrahami - Collaborator - McGill University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill UniversityOutcomes:
The outcome of interest in this study is the treatment trajectory patterns of antidiabetic drug classes. Prescriptions will be identified using BNF codes, listed in Appendix I.
Description: Technical Summary
Sodium-glucose co-transporter 2 (SGLT-2) inhibitors represent the newest pharmacotherapy for the treatment of type 2 diabetes. These drugs were shown to significantly reduce the risk of cardiovascular and mortality events in randomized controlled trials. SGLT-2 inhibitors join the incretin-based drug class, including dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists, as second-to-third line treatments for type 2 diabetes. In 2018, the United States (US) Food and Drug Administration (FDA) began recommending treatment with SGLT-2 inhibitors or GLP-1 receptor agonists in patients with type 2 diabetes and established cardiovascular disease. Despite these recommendations, it remains unclear which drug, if any, is being preferentially prescribed as a second-line treatment in patients with type 2 diabetes.
Thus, we will conduct a multi-site drug utilization study to examine the existing gaps in knowledge in the utilization of second-line antidiabetic drugs in the United Kingdom (UK) and the United States (US). We will use the CPRD, along with two databases from the US: Optum Clinformatics Data Mart and Medicare fee-for-service. Within each data source, we will examine treatment trajectories to examine patterns of use after patients initiate treatment with metformin or sulfonylurea monotherapy. We will also quantify the time to discontinuation of each treatment line to examine persistence. Finally, we will examine the relative proportion of each drug class among patients who add-on or switch to a new medication for each calendar year of the study period. For each of these measures, we will also stratify by the following subgroups: age, sex, body mass index (BMI), hemoglobin A1C (HbA1c), history of cardiovascular disease, and before and after January 1, 2018, corresponding to the latest recommendation by the FDA. Overall, this study will examine how antidiabetic drugs are being prescribed in clinical practice in the real-world setting in the UK and the US.
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Do features occurring prior to MS diagnosis vary according to background: a nested case control study — Ruth Dobson ...
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Do features occurring prior to MS diagnosis vary according to background: a nested case control study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-23
Organisations:
Ruth Dobson - Chief Investigator - Queen Mary University of London
Ruth Dobson - Corresponding Applicant - Queen Mary University of London
Benjamin Jacobs - Collaborator - Queen Mary University of LondonOutcomes:
Primary outcome: multiple sclerosis
This primary outcome will be defined by the occurrence of at least 1 diagnostic code for multiple sclerosis, clinically isolated syndrome, demyelinating disease as used in other primary care data studies (see details below).Secondary outcomes: MS age at first diagnostic code, frailty score (electronic frailty index as defined in [1])
Description: Technical Summary
Previous work using large healthcare datasets has identified an âMS prodromeâ up to 10 years prior to MS diagnosis. Nothing is known about how ethnicity and deprivation interact with or influence features associated with these earliest manifestations. Previous studies have matched and/or corrected for these factors, or have not examined them.
The specific aims of this research project are:
To identify specific constellations of symptoms and/or medical diagnoses occurring prior to MS onset
To establish whether factors vary or interact differently according to gender, deprivation, ethnicity and/or urban/rural classification.
To use the above to identify potentially modifiable aspects of the MS prodrome, which may be limited to one or more groupsThis study will be a combination of descriptive, hypothesis testing, and ideally hypothesis-generating. We hope to generate a âfingerprintâ defining the earliest stages of MS, robust to ethnicity, socio-economic status and rural/urban classification, which could be used prospectively to either predict MS or select high-risk participants in prevention/prediction cohorts.
All medical diagnoses and prescription data present within read codes will be grouped according to clinical symptom constellation using established read code dictionaries. The first recorded diagnosis or symptom for each group of diagnoses will be established for each record. Phenome-wide association testing will be used to determine the association of symptom groups, prescription medications, and diagnoses with a subsequent diagnosis of Multiple Sclerosis.
To determine whether specific prescriptions, symptoms, or diagnoses are associated with subsequent MS, a variety of statistical approaches will be used: multivariable Cox regression, multivariable logistic regression, and machine learning approaches (including penalised logistic regression, gradient-boosted trees, and random forest classifiers). For the standard statistical approaches (Cox and logistic regression), all regression analyses will control for age and sex as confounding covariables. All exposures with sufficient data quality will be tested for association.
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Investigating the conversion rate of routine referrals for patients presenting with symptoms of possible cancer. — Gary Abel ...
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Investigating the conversion rate of routine referrals for patients presenting with symptoms of possible cancer.
Datasets:GP data, HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-22
Organisations:
Gary Abel - Chief Investigator - University of Exeter
Luke Mounce - Corresponding Applicant - University of Exeter
Bianca Wiering - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
1. A routine referral recorded in Hospital Episode Statistics Outpatient (HES OP) data after presenting with one or more symptoms of interest during the 2016-2017 time period. We will initially consider referral requests recorded in secondary care data within two weeks of presentation in primary care, but will explore the appropriateness of other timings.
2. Cancer diagnosis as recorded in cancer registry within 30 days, 60 days, 90 days, 180 days and 1 year of presentation with one or more symptoms of interest.
3. Cancer diagnosis as recorded in cancer registry within 30 days, 60 days, 90 days, 180 days and 1 year of the date the patient was seen in secondary care.
4. Stage at diagnosis of cancers diagnosed within 1 year of presentation; early (TNM stages I and II) vs advanced (TNM stages III and IV).
5. Secondary care interval; days from referral to cancer diagnosis.
6. Survival; days from presentation/referral to death.Description: Technical Summary
National Institute of Health and Care Excellence (NICE) guidelines recommend routine referral for suspected cancer for patients presenting with low-risk features, and urgent referral for high-risk features. Our previous work found that some patients receive a routine referral instead of an urgent referral. Routine referral is more likely to result in longer diagnostic timelines, linked to worse outcomes, so it is important to highlight features where routine referral results in a high number of patients being diagnosed with cancer. We will examine patients who presented with one or more of the following high and low cancer risk symptoms in 2016-2017:
High risk features
Dysphagia
Jaundice
Lumps/masses
Haematuria
Breast lump
Post-menopausal bleedingLow risk features
Weight loss
Anaemia
Abdominal pain
Back pain
Recurrent urinary tract infectionHospital Episode Statistics Outpatient data will be used to derive whether a referral was made, and if it was routine or urgent. Information on cancer diagnoses will be obtained via linkage to the cancer registry.
Mixed effects models (logistic regression for binary outcomes, parametric survival models for intervals) will be used to assess the variability in routine referrals between patient groups, presenting features and between practices/GPs. Cancer diagnoses will be explored across a number of different time windows (30 days, 60 days, 90 days, 180 days and 1-year). Timeliness of cancer diagnoses will be investigated in terms of stage at diagnosis (early vs advanced), survival, and secondary care interval (days from referral to diagnosis).
Benefit to the public health of patients
A greater understanding of which patients receive routine referrals following presentation with symptoms of possible cancer, how many, the proportion of people referred diagnosed with cancer, and the timeliness of such diagnoses will facilitate identification of patient groups who are disadvantaged in the cancer diagnostic pathway. Findings may refine cancer guidance for GPs.
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RECORD-HF: A REtrospective COhort study of heart failure-Related outcomes in patients who are prescribed a loop Diuretic without a diagnosis of Heart Failure — Joe Cuthbert ...
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RECORD-HF: A REtrospective COhort study of heart failure-Related outcomes in patients who are prescribed a loop Diuretic without a diagnosis of Heart Failure
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-23
Organisations:
Joe Cuthbert - Chief Investigator - Hull York Medical School
Joe Cuthbert - Corresponding Applicant - Hull York Medical School
Ahmet Fuat - Collaborator - Durham University
Andrew Clark - Collaborator - University Of Hull
Ireneous Soyiri - Collaborator - University Of Hull
John Turgoose - Collaborator - Hull York Medical School
Judith Cohen - Collaborator - University Of HullOutcomes:
All outcomes assessed at yearly intervals over a five year period.
Primary Outcomes
Number of first hospitalisations with heart failure in any diagnostic position; number of recurrent hospitalisations with heart failure; number of all-cause deaths; time to first hospitalisation with heart failure in any diagnostic position; time to all-cause death; number of new heart failure diagnoses (analysis B); time to heart failure diagnosis (analysis B).
Secondary Outcomes
Number of consultations with breathlessness, fatigue, ankle swelling, or any combination of symptoms; number of patients undergoing natriuretic peptide testing; number of patients undergoing echocardiography; number of patients referred to outpatient cardiology services; number of new prescriptions of loop diuretics (amongst patients in control group 2); number of cause-specific hospitalisations; time to any hospitalisation; number of cardiovascular deaths; time to cardiovascular death.Description: Technical Summary
Loop diuretics are one of the most commonly prescribed medications in primary care. However, there are few indications for loop diuretics other than the treatment of venous congestion in patients with heart failure (HF).
A pilot study at a single General Practice in East Yorkshire found that of 94 patients who were taking loop diuretic without a diagnostic code for HF in their electronic record, 13% were diagnosed with HF, and 25% died or were hospitalised with HF during 2 yearsâ follow up. It is possible that a proportion of these patients had undiagnosed HF as the cause of their symptoms. Furthermore, use of loop diuretics may mask symptoms of congestion without treating the underlying disease; thus delaying diagnosis and worsening outcome. Whether these results are generalisable is unknown.
Our project will use data from the CPRD to investigate the link between loop diuretic prescription and HF-related events in two separate cohort comparisons. Firstly (analysis A), between patients prescribed loop diuretic without a diagnostic code for HF in their electronic record (study population) and patients with a diagnostic code for HF (control group 1), propensity matched for age, sex and co-morbidities. Secondly (analysis B), between the study population and patients with risk factors for HF propensity matched for age, sex and co-morbidities (control group 2). Using independent samples T-test and hazard regressions, we will compare the number of consultations with HF symptoms, the number of new HF diagnoses (analysis B), the number of cause specific hospitalisations and the number of cause specific deaths. We will also compare the time to each event using Cox regression adjusted for important co-variables such as age. Hospital Episode Statistics Admitted Patient Care (HES APC) will be used to determine hospitalisations and Office of National Statistics death registration data will be used to determine deaths.
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The role of ethnicity in opioid prescribing and health service use in the last three months of life: a population-based comparative cohort study of cancer patients — Jonathan Koffman ...
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The role of ethnicity in opioid prescribing and health service use in the last three months of life: a population-based comparative cohort study of cancer patients
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-07
Organisations:
Jonathan Koffman - Chief Investigator - King's College London (KCL)
Jonathan Koffman - Corresponding Applicant - King's College London (KCL)
Emeka Chukwusa - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Sabrina Bajwah - Collaborator - King's College London (KCL)
Stephen Barclay - Collaborator - University of CambridgeOutcomes:
Primary outcome:
The outcome of primary interest is the opioid prescriptions a patient received during the end of life. In the main analysis, the outcome variable will be measured by a binary indicator where âYesâ indicates a patient had been prescribed an opioid with the defined time period and âNoâ otherwise. The outcome variable measured by alternative quantitative scales (e.g. no. of prescriptions, defined daily dose [DDD]-a metric developed by the WHO [1] to enable comparisons between studies[2-4]) may provide more accurate information on the outcome. However, the quality of these data is not always guaranteed (e.g. missing, ways of recording). Therefore, we will analyse the outcome variable using alternative continuous scales, but they will function as sensitivity analysis to test the robustness of the research findings. The continuous outcome variables will be analysed using models appropriate for continuous data (e.g. GLMM with identity link function), so no need to be dichotomised.Secondary outcomes:
Other primary and secondary care service use, including the number of GP visits, number of hospital admissions and length of hospital stays.Description: Technical Summary
BACKGROUND
165,000 UK people die from cancer each year. Pain is common among cancer patients, increasing to 80-90% at the end of life. Despite effective treatments, evidence of under-prescribing of pain medication is common but is not uniformly distributed across society. In the UK, we know from annual national surveys that cancer patients from Black, Asian and ethnicity diverse (BAED) communities are dissatisfied with their pain management. No research has examined analgesic prescribing for pain across different ethnic groups at the end of life. Without answers, itâs impossible to know where/what solutions are required.AIM
To examine the relationship between ethnicity and community prescribing patterns of opioids among UK cancer patients towards the end of life.METHODS
Population-based cohort study using data from UK CPRD linked to HES and ONS of cancer patients diagnosed with lung, bowel, female breast and prostate cancers who died from 2011 to the latest available time point. We will classify opioids into two groups (weak opioids [level 2] and strong opioids [level 3]). A binary indicator for a patient receiving at least one prescription of âLevel 2â and âLevel 3â analgesics as the primary outcome to be examined. The primary outcome will also be defined using the number of prescriptions, âaverage daily doseâ of opioids, cumulative dose and days of supply for sensitivity analysis.Explanatory variables include demographic characteristics and patient-level variables, e.g., cancer site, comorbidities, time interval between cancer diagnosis and death, year of death. Self-reported ethnicity will be collapsed into five categories. Cluster-level variables will include practice-level Index of Multiple Deprivation, regions and urban-rural indicator.
Our analysis comprises three parts: main analysis to generate main results, sensitivity analysis to test for the robustness of results, and mechanistic exploratory analysis to explore the complex relationship between opioid prescribing, ethnicity and other variables of interest.
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Time series analysis of acute kidney injury hospitalisations and gastrointestinal infections diagnosed in primary and secondary care — Laurie Tomlinson ...
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Time series analysis of acute kidney injury hospitalisations and gastrointestinal infections diagnosed in primary and secondary care
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-14
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Hikaru Bolt - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Acute kidney injury diagnosed in secondary care; Admitted Patient Care. We will define AKI in HES as having a record of at least one AKI ICD-10 N-17, N-19 code in the first or second diagnostic position in any episode within seven days of admission.
Acute gastroenteritis diagnosed in secondary care; Admitted Patient Care. We will define secondary care admission for gastroenteritis in HES as ICD-10 codes A00âA09, K52.8, K52.9, R11, and R19.7 which includes diagnoses for infectious and non-infectious gastroenteritis.
Acute gastroenteritis diagnosed in primary care; CPRD. We will define primary care visits for gastroenteritis using a previously described method by Mansfield et al (1). Gastroenteritis will be defined as either a definite diagnosis code or a combination of symptom codes with a
Description: Technical Summary
AKI is a syndrome defined by rapid decline in kidney function leading to disruption in metabolic, electrolyte, and fluid homeostasis. Between 20-25% of hospitalised patients have AKI and is associated with a 4-16 fold increase in odds of death. Recent studies have shown that AKI hospitalisations in the UK may have a seasonal pattern, indicating potential associations with communicable diseases such as norovirus. The aim of this project is to explore whether AKI is seasonal in England, and whether gastrointestinal infections diagnosed in these patients follow a similar seasonal pattern. Any association would be an important consideration in future work modelling the health economic impacts of a norovirus vaccination programme in the UK.
Objectives: i) describe seasonality of AKI hospitalisations ii) describe trends of AKI hospitalisations following a diagnosis of gastroenteritis in primary care iii) describe trends of AKI hospitalisations where concurrently diagnosed with gastroenteritis in secondary care iv) describe trends of gastroenteritis in primary and secondary care overall v) describe the characteristics of people hospitalised with AKI following a diagnosis of gastroenteritis vi) describe trends of AKI hospitalisations following a diagnosis of lower respiratory tract infections in primary care. Study populations: patients hospitalised with AKI, patients hospitalised with gastroenteritis, patients presenting to primary care for gastroenteritis. Primary outcome: hospitalisation with AKI. Exposures: gastroenteritis diagnosed in primary care, gastroenteritis diagnosed in secondary care, age, sex, comorbidities, IMD. Study design: observational cohort. Data analysis: time series plots will be produced to examine AKI trends over time compared to gastroenteritis trends diagnosed in primary and secondary care in people hospitalised with AKI and overall. Time series analysis will be conducted describing the signals, secular trends, and seasonal factors using a linear regression model fitted to each time series. To validate seasonal reporting of gastroenteritis, time series trends of LRTIs will be described.
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Hearing loss and risk of major osteoporotic fracture: a population-based cohort study in the United Kingdom — Laura Canals ...
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Hearing loss and risk of major osteoporotic fracture: a population-based cohort study in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-10
Organisations:
Laura Canals - Chief Investigator - Amgen (Europe) GmbH
Michaela Ratzinger - Corresponding Applicant - Amgen (Europe) GmbH
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Marta Pineda Moncusi - Collaborator - University of Oxford
Nadeem Qureshi - Collaborator - University of Nottingham
Richard Baxter - Collaborator - Amgen Inc
Sara Khalid - Collaborator - University of Oxford
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Primary Outcomes:
Major osteoporotic fracture: clinical spine, wrist/forearm, shoulder/proximal humerus, and hip fracture
These will be identified using previously established lists of READ codes.Secondary Outcomes:
Performance (calibration and discrimination) of major osteoporotic fracture (clinical spine, wrist/forearm, shoulder/proximal humerus or hip fracture) prediction tools for 1- and 10-yearsVariables:
Outcome Variable(s)
Major osteoporotic fracture: clinical spine, wrist/forearm, shoulder/proximal humerus, and hip fractureExposure Variable(s)
Exposure is hearing loss defined as: first diagnosis/record of hearing loss or impairment.Other Covariate(s)
Risk factors included in the QFracture (2) prediction tool (https://qfracture.org/) plus other risk factors described in the literature (socio-economic status, occupation, family history and previous meningitis)Description: Technical Summary
Objectives:
To assess the association between hearing loss/impairment and major osteoporotic fracture risk (Objective 1)
To identify risk factors associated with 1- and 10-year major osteoporotic fracture risk amongst patients with hearing loss/impairment (Objective 2)
To combine key predictors of fracture risk to derive major osteoporotic prediction tools (1- and 10-years) (Objective 3)Hypothesis:
To test if there is an association between hearing loss and major osteoporotic fracture risk.Population:
Patients registered in CPRD for at least one year before becoming eligible (index date). Study period: January 1, 2001 to October 31, 2020, or the latest date of CPRD data availability.Eligibility Criteria:
Registered in CPRD for at least one year before the index date
2 subcohorts:
Hearing loss cohort: first diagnosis/record of hearing loss or impairment.
Unexposed cohort: no record of hearing loss/impairment matched to each participant in the hearing loss cohort by year of birth, sex, general practitioner, and year at index dateOutcomes:
Primary: Major osteoporotic fracture: clinical spine, wrist/forearm, shoulder/proximal humerus, and hip fracture
Secondary: Performance of major osteoporotic fracture prediction tools for 1- and 10-yearsData Analysis:
Association analysis between hearing loss/impairment and fracture risk:
absolute and relative risk estimates of overall major fractures and of each major fracture subtype associated with hearing loss
Identification of the risk factors associated with 1- and 10-year major osteoporotic fracture risk amongst patients with hearing loss, and the consequent model development.Data Sources:
CPRD: Socio-demographics, medical history and treatments, to be adjusted for in the analysis of objective 1-3.
HES APC linkage will allow us to determine hospitalisations which will inform risk factors for objective 2 and 3.
ONS death records will be used to inform outcome status (death) in the analysis of objectve 3 to account for primary outcome (fracture risk) with a competing risk of death.
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Comparative effectiveness of Umeclidinium+Vilanterol versus Tiotropium Bromide+Olodaterol among patients with Chronic Obstructive Pulmonary Disease in a real-world primary care setting in the UK — Gema Requena ...
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Comparative effectiveness of Umeclidinium+Vilanterol versus Tiotropium Bromide+Olodaterol among patients with Chronic Obstructive Pulmonary Disease in a real-world primary care setting in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-23
Organisations:
Gema Requena - Chief Investigator - GlaxoSmithKline - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Catherine Castillo - Collaborator - Adelphi Real World
Eunmi Ha - Collaborator - Adelphi Real World
Jie Yeap - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Mean number of rescue medication prescriptions; Medication adherence (PDC â¥80%); Proportion of patients receiving triple therapy; Time-to-triple therapy
NOTE TO REVIEWER: Your comment raised concern that the primary outcome variable ârescue medication useâ will be observed over a variable follow-up period, and that the study design does not account for this. We would ask you to consider that this outcome will be observed in distinct time periods after index (6, 12, 18 and 24 months) to allow us to observe any change in comparative rescue medication use over time since index. We also chose to observe mean number of rescue medication prescriptions because this was a more common approach in similar studies in the literature, and to align with a related GSK US study. For a given time period being assessed, only patients with follow-up extending at least as long as that time period will be included in that analysis. Therefore, while patients with varying lengths of follow-up may be included in the study cohort, only those with sufficient follow-up will be included in specific analyses. This is described in the third paragraph of the Study design section. We are unable to make amendments to the content of the form to make this clearer because both the Study Design and Data/Statistical Analysis sections are locked to editing, and the Outcomes to be measured section is specified to only be a list of variables with no further explanation. We hope this approach to responding to your feedback is sufficient.
Regarding your second point, we have added a statement to the Limitations section to explain that rescue medication may be prescribed for other reasons than worsened symptoms, but that these other reasons are not expected to be differential between groups, and that if prescriptions are occurring for other reasons, it would lead to an underestimation of treatment effect for this outcome.Description: Technical Summary
Aim: To compare real-world effectiveness of Umeclidinium/Vilanterol (UMEC/VI) versus Tiotropium Bromide/ Olodaterol (TIO/OLO) on rescue medication use and medication adherence among a General Practice (GP) cohort of patients with chronic obstructive pulmonary disease (COPD) in England. Greater understanding of the effectiveness of these maintenance therapy options will better-inform early treatment choices for patients with COPD in the UK.
Objectives: To compare i) mean number of rescue medication prescriptions and ii) medication adherence in patients newly-initiating UMEC/VI versus TIO/OLO. The exploratory objective is to describe the proportion of patients receiving triple therapy and time until triple therapy initiation among UMEC/VI and TIO/OLO patients.
Primary exposures: Single inhaler UMEC/VI or TIO/OLO initiation.
Primary outcome: Rescue medication use (inhaled or nebulized short-acting beta agonist [SABA]- or muscarinic antagonist [SAMA]- containing medication) 12 months following treatment initiation.
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) to adjust for measured confounders will be employed to assess UMEC/VI efficacy using linked CPRD and Hospital Episode Statistics (HES) data. The first/earliest date of dual therapy (UMEC/VI or TIO/OLO) initiation between July 2015 and September 2019 will determine the index date. No minimum follow-up is required for study inclusion, a 24 months maximum follow-up will be used to assess effectiveness outcomes.
Data analysis: A propensity score (PS) based methodology will be implemented to minimise potential confounding and evaluate average treatment effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Rescue medication use will be compared between unweighted and weighted treatment cohorts, and 95% CIs and p-values generated from a generalised linear least squares regression model. Adherence will be classified using proportion of days covered (PDC): PDC<80% considered non-adherent, PDCâ¥80% adherent. Time-to-triple therapy will be assessed using Kaplan-Meier survival analysis and Cox proportional hazards models.
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Risk of major adverse cardiovascular events in patients with elevated low-density lipoprotein cholesterol, excluding atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease -risk equivalent and familial hypercholesterolemia patients — Christopher Morgan ...
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Risk of major adverse cardiovascular events in patients with elevated low-density lipoprotein cholesterol, excluding atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease -risk equivalent and familial hypercholesterolemia patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-20
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Jasper Huels - Collaborator - Novartis Pharma AGOutcomes:
Revascularization; Unstable angina; Non-fatal myocardial infarction; Non-fatal stroke; Cardiovascular death; Non-cardiovascular death
Description: Technical Summary
High levels of low-density lipoprotein cholesterol (LDL-C) are associated with increased risk of cardiovascular event and there is evidence that the greater the absolute LDL-C reduction, the greater the reduction in risk. We wish to conduct a non-comparative study using the Clinical Practice Research Datalink (CPRD) with data from the Hospital Episode Statistics admitted patient care dataset and Office of National Statistics (ONS) mortality to ascertain both baseline covariates and outcomes. ONS index of multiple deprivation quintiles will be used for descriptive analyses. The objective is to determine the probability of cardiovascular event for patients with hypercholesterolaemia but otherwise low cardiovascular risk. Patients with elevated LDL-C (â¥2.6 mmol/L) will be selected from CPRD Aurum and their estimated ten-year risk of major adverse cardiovascular event (MACE) will be calculated using both the American College of Cardiology/American Heart Association atherosclerotic cardiovascular disease (ASCVD) risk prediction algorithm and the European Society of Cardiology SCORE-2 risk prediction algorithm. From each algorithm, three cohorts will be defined based on their risk score of below 5%, 5% or higher or 7.5% of higher. Patients with either i) familial hypercholesterolemia (FH), ii) history of ASCVD iii) ASCVD-risk equivalence will be excluded from this analysis as these patients have an increased risk and have been previously studied in a CPRD study over the same time-period. These cohorts will be described in in terms of demographics, cardiovascular and non-cardiovascular comorbidity, baseline biochemistry and baseline therapy profile. Crude rates of mortality and MACE will be calculated by person year at risk and stratified by age, gender and type 2 diabetes status. Kaplan Meier tables will be created to estimate the probability of MACE, cardiovascular and non-cardiovascular related deaths. This will inform the potential benefit from initiation on alternate therapies for patients with refractory hypercholesterolaemia but otherwise perceived low cardiovascular risk.
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Covid-19 vaccination in inflammatory conditions treated with immune suppressing drugs: a study of clinical effectiveness and vaccine safety using data from the Clinical Practice Research Datalink (CPRD) — Abhishek Abhishek ...
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Covid-19 vaccination in inflammatory conditions treated with immune suppressing drugs: a study of clinical effectiveness and vaccine safety using data from the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-13
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Abhishek Abhishek - Corresponding Applicant - University of Nottingham
Christian Mallen - Collaborator - Keele University
Georgina Nakafero - Collaborator - University of Nottingham
Hywel Williams - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of NottinghamOutcomes:
Clinical effectiveness study:
Outcomes:Primary: Hospitalisation with Covid-19 infection. Defined as present if there is an international classification of diseases (ICD)-10 code in either the inpatient HES or a positive record in Covid-19 Hospitalisation in England Surveillance System (CHESS) datasets.
Secondary:
a. Primary-care diagnosis of Covid-19. This will be defined as either a GP-consultation with valid Snomed code, or a positive PCR test result recorded in the CPRD. GP electronic health records get positive PCR results from NHS test and trace, and NHS digital.b. Death due to Covid-19 infection defined using death certificate data available as ICD-10 codes in the ONS dataset.
c. Death within 28-days of a positive Covid-19 test.
The CPRD HES/ONS linked data are only available to November 2020 (Set 20). It is currently unclear when the next release of linked data will occur. Given the time sensitive nature of this study, we will first evaluate vaccine efficacy using primary-care diagnosis of Covid-19, and death within 28-days of a positive Covid-19 test. The latter outcome will be defined using death date and positive Covid-19 PCR test recorded in CPRD Aurum primary-care data. The results of these analyses will be published and disseminated to policy makers as soon as ready.
Once the HES and ONS linked data are available, we will examine the effectiveness of vaccines against Covid-19 on hospitalisation and re-examine the effectiveness of vaccines against Covid-19 on mortality using ONS data respectively.
Vaccine safety study:
[1] Primary care consultation for joint pain or autoimmune rheumatic disease with a new corticosteroid prescription within +/-1 day.
[2] Primary care consultation for diarrhoea, abdominal pain, rectal-bleeding with a new corticosteroid prescription within +/-1 day, or hospitalisation for inflammatory bowel disease.
[3] Primary care consultation for psoriasis, atopic dermatitis or eczema and prescription of a new topical treatment within +/-1 day.
Description: Technical Summary
Background: Safety and effectiveness of SARS-CoV-2 vaccines in inflammatory conditions is poorly understood.
Objectives: [1].Evaluate effectiveness of SARS-CoV-2 vaccines in inflammatory conditions treated with immune-suppressive medicines. [2].Compare clinical effectiveness of mRNA or vectored DNA vaccines in this population. [3].Examine association between SARS-CoV-2 vaccination and flare-up of inflammatory disease.
Methods: Data from Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics, COVID-19 Hospitalisation in England Surveillance System, Office of National Statistics, and Practice Level Index of Deprivation will be used. CPRD Aurum contains details of diagnoses, prescriptions, and immunisations including with the SARS-CoV-2 vaccines. Dates of vaccination and vaccine brand are recorded.
Clinical effectiveness:
Study design: Cohort study (01/12/2020 to 31/05/2022)
Exposure: Age >18 years, diagnosed with inflammatory bowel, skin or rheumatic disease prescribed immune-suppressing medicine(s).
Unexposed: One age, sex, SARS-CoV-2 vaccine-type, vaccination date (+/-5 days), and time between first and second vaccine dose (+/-1 week) matched participant.
Outcomes: Primary: Hospitalisation with Covid-19. Secondary: Primary-care diagnosis of Covid-19, death due to Covid-19.
Follow-up: From 14 days after the first dose to earliest of date of outcome, death, last data collection, leaving GP-surgery or 31/05/2022.
Analysis: Cox regression will be used to calculate hazard ratios and 95% confidence intervals (CI), adjusted for covariates. Interaction terms will be fitted for prognostic factors and stratified analysis performed. Analyses will be restricted to 6, 9 and 12 months to examine the duration of protection.Vaccine safety:
Design: Self-controlled case series.
Population: Vaccinated and outcome of interest.
Periods:
Exposed: Three-weeks following each of the SARS-CoV-2 vaccines.
Pre-exposure: 2-weeks before the vaccinations.
Unexposed: Remaining follow-up time.Analysis: Poisson model will be used to calculate incidence rate ratios and 95% CI for the exposed period, including season as covariate.
Impact: The findings of this study have the potential to influence the timing of future booster vaccinations.
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Longitudinal trajectories of work absence in patients with musculoskeletal and, or, mental health conditions — Gwenllian Wynne...
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Longitudinal trajectories of work absence in patients with musculoskeletal and, or, mental health conditions
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-22
Organisations:
Gwenllian Wynne-Jones - Chief Investigator - Keele University
Amardeep Legha - Corresponding Applicant - Keele University
Clare Holdsworth - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Victoria Welsh - Collaborator - Keele UniversityOutcomes:
STUDY 1
Rates and duration of work absenceSTUDY 2
Trajectories of work absence (derivation)STUDY 3
Trajectories of work absence (association of characteristics)Description: Technical Summary
BACKGROUND
Ability to work is one of the biggest drivers of social inequalities, leading to adverse health and social outcomes. Absence from work due to musculoskeletal and/or mental health conditions accounts for the majority of healthcare costs and productivity losses. Most people return-to-work relatively quickly following an episode of healthcare, but approximately 10% go on to have a longer-term work absence of > 12 months.
Fit notes are statements issued by GPs that record their medical recommendations regarding a potential return-to-work for patients absent for more than 7 days. They are recorded in primary care electronic health records; access to such data potentially allows uncovering of patterns of work absence over time (trajectories). Knowledge of these trajectories and associated characteristics could help GPs better distinguish patients at higher risk of sustained long-term work absence during initial consultation, and thus potentially offer earlier and more targeted intervention to such patients.
AIMS AND OBJECTIVES
1) To derive, and compare using different statistical methods, common longitudinal trajectories of work absence as measured by receipt of fit notes, for a population consulting their GP with a musculoskeletal and/or mental health condition
2) To derive health and sociodemographic characteristics associated with these trajectoriesMETHODS
For a population absent from work due to musculoskeletal and/or mental health conditions:
Study 1: Derivation of rates and duration of work absence (2010-2021), with differences examined by: sociodemographic characteristics (age, sex, and geographic region).
Study 2: Derivation of trajectories of work absence (2016-2018); contrasted using simple methods of modelling trajectories, against more complex approaches (such as different types of latent class analysis).
Study 3: Multivariable multinomial regression analyses to test association of each derived trajectory with the sociodemographic characteristics specified in study 1, as well as deprivation status, health characteristics, comorbidity, and treatment received.
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Effectiveness of glucosamine on mortality and cancer incidence in patients with osteoarthritis — Samy Suissa ...
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Effectiveness of glucosamine on mortality and cancer incidence in patients with osteoarthritis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-17
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Marie Hudson - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
- Overall cancer
- Three site-specific cancers: colorectal, lung and prostate
- All-cause mortality.Description: Technical Summary
Glucosamine, a natural compound found in cartilage, is a non-vitamin, non-mineral supplement used to treat joint pain and osteoarthritis. The several large observational studies that have associated glucosamine use with significant reductions in mortality, cancer incidence, cardiovascular disease, diabetes and chronic obstructive pulmonary disease (COPD) were not based on new-user designs. As a result, these studies were potentially affected by selection bias due to collider stratification, as all studies enrolled âprevalentâ cohorts.
The objective of this study is to assess the effect of glucosamine use compared with non-use on the incidence of cancer and mortality using the CPRD.
To avoid the selection bias affecting other studies, we propose to use the prevalent new-user design to compare the effect of new use of glucosamine with non-use on the incidence of cancer and mortality. Thus, we will first form a base cohort of all subjects from CPRD practices who are 30 years of age or more between January 1995 and December 2017, with a diagnosis of osteoarthritis and at least one year baseline data.
From the base cohort we will first ascertain all subjects who initiate glucosamine and match a reference non-user at the same time point (cohort entry) using a prevalent new-user design approach. The matching will be done on sex and time-conditional propensity scores. Matched subjects will be followed for up to 10 years or until the occurrence of death or a first cancer. The Cox proportional hazard model will be used to assess the effect of glucosamine use versus non-use on the risk of death and cancer incidence.
While glucosamine is no longer prescribed in the UK, it is available over-the-counter. This studyâs design, that circumvents selection bias, will clarify whether the numerous claims of this supplementâs merits on mortality and cancer are founded or lead to unnecessary overuse.
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Patterns and clinical outcomes of cardiovascular medication use after a cancer diagnosis in patients with heart failure — Chengsheng Ju ...
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Patterns and clinical outcomes of cardiovascular medication use after a cancer diagnosis in patients with heart failure
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-23
Organisations:
Chengsheng Ju - Chief Investigator - University College London ( UCL )
Li Wei - Corresponding Applicant - University College London ( UCL )
Charlotte Manisty - Collaborator - University College London ( UCL )
Pinkie Chambers - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )Outcomes:
1) Proportion of patients using heart-failure-managing medications;
2) Mortality (all-cause, cardiovascular death and cancer-related death);
3) First hospitalisation for heart failure (HHF).Description: Technical Summary
Maintaining an optimal guideline-directed medical therapy (GDMT) for heart failure (HF) is essential for achieving the best possible clinical outcomes in patients with HF. Recent studies have suggested that patients with HF are at an elevated risk for cancer development. The aims of this study are to 1) determine the pattern of cardiovascular medication use before and after the cancer diagnosis in patients with pre-existing HF; 2) identify patient characteristics to predict changes in the GDMT medications; 3) investigate the association between the use of GDMT medications and the risk of hospitalisation for HF and mortality after the patient developed cancer.
We will conduct a retrospective cohort study using data between 1st January 2005 and 31st December 2020. The data sources will be CPRD GOLD and Aurum linked to HES data, ONS data, and Multiple Deprivation Index data.
We will first define a patient cohort with any new cancer diagnosis and pre-existing HF. For the first objective, we will describe the trend of use of GMDT medications after the cancer diagnosis, compared to the patterns before cancer diagnosis. The daily dose of the GMDT medications received by patients will be compared to the guideline recommendations. The time windows for the prescription trend description will be from six months before and six months after the cancer diagnosis. For the second objective, we will use multivariable logistic regression to find patient factors predicting the change in the use of GDMT medications. For the third objective, we will compare the mortality and hospitalisation risks among patients with different GDMT treatments. All patients will be followed from the cancer diagnosis until the outcome or censoring event or the end of the study. We plan to adjust for any confounding by inverse probability treatment weights (IPTWs) using the propensity score and marginal structural models (MSMs).
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Association between thrombosis with thrombocytopenia syndrome (TTS) or thromboembolic events, and covid-19 vaccines — Daniel Prieto...
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Association between thrombosis with thrombocytopenia syndrome (TTS) or thromboembolic events, and covid-19 vaccines
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-07
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Victoria Y Strauss - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University Hospitals
Junqing Xie - Collaborator - University of Oxford
Xintong Li - Collaborator - University of OxfordOutcomes:
We will use the observational medical outcomes partnership (OMOP) common data model (CDM) to harmonise data from both CPRD GOLD and AURUM. Numerous code lists and algorithms have been validated for the study of vaccines and related outcomes using the OMOP CDM through ongoing research in collaboration with international regulators and academics (1-3).
Preliminary concept lists of the outcomes are shown in Appendix.
⢠TE will contain the following:
o Deep vein thrombosis (DVT)
o Pulmonary embolism (PE)
o Venous thromboembolism (VTE) as a composite of DVT or PE
o Cerebral venous sinus thrombosis (CVST)
o Splanchnic and visceral vein thrombosis (SVT)
o Ischemic stroke
o Myocardial infarction
o Arterial thromboembolism (ATE) as a composite of the two above and other rare arterial thromboembolisms defined in Appendix.
VTE and ATE will be assessed separately for Objectives 2, 3, and 4.
⢠TTS
Our definition of TTS, the primary outcome for Objective 1a, 1b and 3, is based on the one proposed by the Brighton collaboration (4), and encompasses the occurrence of one of the TE of interest above with concurrent thrombocytopenia within 10 days before/after the thromboembolic event date after the vaccination.
Thrombocytopenia will be identified either by a diagnostic code or a measurement of <150,000 platelets per microliter of blood as proposed by the Brighton collaboration, observed over a time window post vaccination starting ten days prior to the event of interest and up to ten days afterwards. This definition has been implemented in the OMOP CDM as part of our ongoing study (5).
We will explore additional time window and threshold for thrombocytopenia according to the latest evidence and guideline.We will explore if mortality as a competing outcome of TTS/TE in a sensitivity analysis.
Description: Technical Summary
BACKGROUND
TTS are being investigated as potential adverse effects of viral vector-based COVID-19 vaccines. Evidence on this association is subject to selection bias and confounding. Insights into the magnitude of TTS risk related to COVID-19 vaccination is urgently needed. This study is part of a European Medicines Agency tender to investigate this.OBJECTIVES
1) To study the association between the administration of a COVID-19 vaccine and the occurrence of thrombosis with thrombocytopenia syndrome/s (TTS) and thromboembolic events (TE).
2) To quantify the association between the administration of different COVID-19 vaccine brands and the occurrence of TTS and VTE events.
3) To study the association between pre-specified risk factors and the occurrence of post-vaccine TTS/TE
4) To characterize the treatments used in vaccinated patients after TTS/TE.METHODS
Data: OMOP mapped version of CPRD GOLD and AURUM
Participants: All adults registered in CPRD GOLD/AURUM for >one yearPropensity Score (PS) matching with 1 (vaccinated): 1 (unvaccinated) ratio will be used to account for confounding in Objective 1. In the derived PS matched sample, the incidence rate of TTS/TE in unexposed will be compared to rates among exposed person-time after COVID-19 vaccine/s using Poisson models. Negative control outcomes will be used to assess residual confounding.
Objective 2. A separate PS will be estimated and used to match people vaccinated with ChAdOx1 (Vaxzevria) to those receiving BNT162b2 (Comirnaty). Rates of TTS/TE post-vaccine will be compared and Rate Ratios estimated in the PS matched cohorts using Poison modelling.
3: Logistic regression will be used to estimate unadjusted as well as age and sex-adjusted Odds Ratios for pre-specified risk factors including socio-demographics, comorbidities, and medicine/s use.
4. Sunburst plots will be used to depict treatment pathways following post-vaccination TTS/TE.
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A post-authorisation (post-marketing) observational study using existing secondary health data sources to evaluate the association between exposure to the AstraZeneca COVID-19 vaccine (AZD1222) and safety concerns — Saad Shakir ...
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A post-authorisation (post-marketing) observational study using existing secondary health data sources to evaluate the association between exposure to the AstraZeneca COVID-19 vaccine (AZD1222) and safety concerns
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register; COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-23
Organisations:
Saad Shakir - Chief Investigator - Drug Safety Research Unit
Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Hai Nguyen - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research UnitOutcomes:
Safety outcomes:
Outcomes include the safety concerns and other AESIs listed in the current approved AZD1222 EU Risk Management Plan (RMP) and also new safety events of interest raised by the EMA after evaluation of cases involving thrombocytopenia with thrombosis or bleeding. The AESIs differ in terms of latency, acuity of onset, availability of empirical estimates for appropriate risk periods, and the effect of the event on subsequent likelihood of vaccination. The AESIs to be analysed in this study are: Vaccine-associated enhanced disease, including vaccine-associated enhanced respiratory disease (e.g. acute respiratory distress syndrome, ARDS); Multisystem inflammatory syndrome in adults/children; Sudden death; Autoimmune thyroiditis; Anosmia, ageusia; Anaphylaxis; Type III hypersensitivity reactions; ARDS; Guillain-Barré syndrome; Other peripheral and polyneuropathies; Multiple sclerosis, transverse myelitis, and other demyelinating disorders; Optic neuritis/neuromyelitis optic spectrum disorder; Encephalitis (including acute disseminated encephalomyelitis); Myasthenia gravis; Bellâs palsy; Generalised convulsions; Narcolepsy; Myocarditis/Pericarditis; Postural orthostatic tachycardia syndrome; Myocardial infarction; Acute cardiac injury including microangiopathy, cardiogenic shock, heart failure, stress cardiomyopathy; Thrombocytopenia; Thrombocytopenia with associated bleeding; Thrombosis (embolic and thrombotic events) without thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Capillary leak syndrome; Acute kidney injury; Acute liver injury; Acute pancreatitis; Acute aseptic arthritis; Fibromyalgia; Rhabdomyolysis; Chronic fatigue syndrome/ME/PVFS; Erythema multiforme; and Chilblain-like skin lesions.
The study will also estimate the incidence rates of AESIs. First in period (possible recurrent) events will be assessed and case definition algorithms will be based on codes for diagnoses, procedures, and treatments. Definitions, codes, and proposed algorithms for all AESI will incorporate definitions developed by the ACCESS project (http://www.encepp.eu/encepp/viewResource.htm?id=37274) (https://drive.google.com/drive/folders/1Y_3cuGRN1g-jBv2ec1fC0aYcpxEjtrY9).
If feasible, algorithms to determine selected AESIs will be validated in a sample of cases based on manual review of electronic records (electronic records here relates to the data from CPRD Aurum and linked datasets, extracted as part of this study). This will be conducted by clinicians blinded to COVID-19 vaccine exposure, which will also involve use of a validation case report form (CRF) for cases that will be subject to an event or case verification and validation procedure. Information to complete the validation CRF will only be obtained from data extracted as part of the study i.e., CPRD Aurum and linked datasets. This study will not involve any further contact with GPs or patients. If validation is performed, certainty of an event diagnosis will be classified against existing and as-yet developed standardised definitions such as those created by the Brighton Collaboration.
Description: Technical Summary
The Covid-19 vaccine AstraZeneca AZD1222 (called Vaxzevria® in Europe) has been authorised for use in the European Union (EU), for prevention of COVID-19. Due to the shortened pre-authorisation development period and the limited clinical trials for COVID-19 vaccines, post-authorisation safety studies (PASS) are required to continue monitoring safety. This CPRD study, conducted in Aurum database, forms the UK component of this multi-database multi-country study conducted in Europe, fulfilling European Medicines Agency (EMA) requirements.
The study aims to determine whether there is an increased risk of prespecified adverse events of special interest (AESI) after vaccination with AZD1222. A retrospective cohort design and a self-controlled risk interval (SCRI) design will be used to compare individuals who have received at least one dose of AZD1222 with those who have not yet received any COVID-19 vaccine for the occurrence of AESIs. The cohort study design will be used to estimate incidence rates of prespecified AESI among individuals who receive at least one dose of AZD1222.
A cohort study and SCRI design will be used to describe incidence rates and determine whether an increased risk of prespecified AESI exists following at least one dose of AZD1222 compared with a matched comparator group with no COVID 19 vaccination, within sub-cohorts of interest with missing information. Areas of missing information include use of AZD1222 in pregnant or breastfeeding women, use in immunocompromised individuals, use in frail individuals with comorbidities, use in those with autoimmune or inflammatory disorders, and interactions with other vaccines and long-term safety.
In addition, the study will characterise utilisation patterns of AZD1222 by estimating the proportion of individuals receiving the vaccine; two-dose vaccine completion rate and distribution of time gaps between the first and second dose, demographics and clinical characteristics of recipients, overall and among sub-cohorts of interest.
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Do Sodium-glucose inhibitors co-transporter-2 inhibitors (SGLT-2) decrease the risk of sudden cardiac death compared to other second or thirdline oral diabetic drugs? — Patrick Souverein ...
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Do Sodium-glucose inhibitors co-transporter-2 inhibitors (SGLT-2) decrease the risk of sudden cardiac death compared to other second or thirdline oral diabetic drugs?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-12-06
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Hanno L Tan - Collaborator - Not from an Organisation
Marieke Blom - Collaborator - University of Amsterdam
Ruben Coronel - Collaborator - University of Amsterdam
Talip Eroglu - Collaborator - Utrecht UniversityOutcomes:
The composite outcome includes cardiac arrest (medcode: 2099, 5925, 21195, 33899, 25583, 49882), sudden death (medcode: 23075, 73130, 6811, 23830) , asystole (33402), cardio-respiratory arrest (medcode: 25407), all resuscications (medcode: 28236, 39285, 23335, 51140, 96801, 99337) and sudden death (medcode: 23075, 73130, 6811, 23830).
Secondary outcome will be all-cause mortality, as captured by CPRD death date; both as seperate event and in combination with the main composite outcome.NB. Appendices provided are the product codes used for extraction of exposure drugs and insulin.
Description: Technical Summary
Previous clinical trials demonstrated that Empagliflozin (SGLT2-inhibitor) lowers the risk of cardiovascular death and hospitalization for heart failure in patients with type 2 diabetes. In addition, experimental studies have shown that Empagliflozin has direct cardiac effects by lowering the cytoplasmic Na+ and Ca2+ concentration in ventricular cardiomyocytes. This may decrease the risk of ventricular arrhythmias, and sudden death, because increases in cytoplasmic Na+ and Ca2+ are associated with increased risk for ventricular arrhythmias, which is the predominant cause of sudden cardiac arrest. However, this has not been studied yet on a population-level. Thus, our objective is to examine whether SGLT2-inhibitor use is associated with a lower risk of SCA and sudden death in patients with type 2 to diabetes in a real-world setting compared to other second-to-third-line antidiabetic drugs. Using CPRD, we will select a study cohort of new users of antidiabetic drugs between 2013 and 2019. We will study the incidence of SCA cardiac arrest and sudden death among current users of SGLT2-inhibitors versus current users of other second-to-third-line antidiabetic drugs. Several potential confounders will be considered, such as age, sex, body mass index, smoking, HbA1c, comorbidities and co-medications., comorbidities and smoking. Cox regression analysis will be used to estimate hazard ratios (HRs) and 95% confidence intervals.
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Registered vs Census population comparison
— Westminster City Council...
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Registered vs Census population comparison
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Census.
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ICP Dashboard for NW London & Harrow Council — Harrow Borough...
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ICP Dashboard for NW London & Harrow Council
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Harrow Borough-based Partnership
Description: Harrow.
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Understanding the impact of CLCH community services on patient health in NW London — CLCH...
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Understanding the impact of CLCH community services on patient health in NW London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: CLCH
Description: CLCH community services .
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AIR TEXT alternative
— Westminster City Council...
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AIR TEXT alternative
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Heart or Lung Conditions.
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Air pollution and health Marylebone exploratory analysis
— Westminster City Council...
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Air pollution and health Marylebone exploratory analysis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Air Pollution, Marylebone.
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Children & Young People JSNA (CYP JSNA)
— London Borough of Brent...
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Children & Young People JSNA (CYP JSNA)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: London Borough of Brent
Description: JSNA.
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Autism in WCC and RBKC
— Westminster City Council...
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Autism in WCC and RBKC
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Autism.
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Estimating inequalities in unmet clinical need in patients with obesity
— Lane Clark & Peacock LLP...
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Estimating inequalities in unmet clinical need in patients with obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Obesity. Commercial
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KCW – increasing complexity analysis (older adult integrated approaches) — Central and North West London NHS Foundation Trust...
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KCW – increasing complexity analysis (older adult integrated approaches)
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Central and North West London NHS Foundation Trust
Description: Older Adults.
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Improving patient outcome prediction for patients based on health records — Imperial College London...
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Improving patient outcome prediction for patients based on health records
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Patient Outcome Prediction.
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Heart Failure Pathway Transformation: Health Economic Analysis. — Imperial College Healthcare NHS Trust...
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Heart Failure Pathway Transformation: Health Economic Analysis.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart Failure. Commercial
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ID-180: Population Health Monitoring BAU
— Westminster City Council...
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ID-180: Population Health Monitoring BAU
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Covid Recovery.
Source -
Children’s Health Monitoring — Westminster City Council...
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Children’s Health Monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Mental health, Covid and Obesity.
Source -
Grenfell Population Health Monitoring
— Westminster City Council...
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Grenfell Population Health Monitoring
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: North Kensington.
Source
2021 - 11
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A cohort study of pre-pregnancy infections and risks of preterm birth — Laila Tata ...
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A cohort study of pre-pregnancy infections and risks of preterm birth
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-17
Organisations:
Laila Tata - Chief Investigator - University of Nottingham
Mark Chester - Corresponding Applicant - University of Nottingham
Raheela Khan - Collaborator - University of NottinghamOutcomes:
Gestational age of spontaneous (non-iatrogenic) birth; Term categorisation of spontaneous birth (extremely/very preterm/ moderately preterm/ term/ late term); Gestational age of any episode of threatened pre-term birth;
Gestational age of pre-term pre-labour rupture of membranes (PPROM).Description: Technical Summary
We postulate that a significant infective event prior to pregnancy can alter downstream signalling pathways that lead to priming and exacerbation of an inflammatory cascade, which in turn increases the rate of birth prior to 37 weeks gestation. Using the Clinical Practice Research Datalink (CPRD) general practice data with individual patient links to Hospital Episode Statistics (HES), including maternity HES information we will examine all pregnancies. We will extract outcome, delivery and birth details using mothersâ and childrenâs HES and primary care records to characterize timing and type of preterm delivery, e.g., spontaneous or other reasons/unexplained where possible. Using Read codes and ICD-10 codes in primary and secondary care data respectively, we will extract infections occurring within the 5 years before pregnancy, and characterize these as they present clinically (e.g., respiratory, urinary tract, vaginal, gastrointestinal, dermatological), the prescribing frequency of antibiotics or antivirals and the infective agent e.g., influenza, pneumonia, rubella, hepatitis, herpes simplex virus) wherever specified in the clinical record.
We will calculate incident rates of pre-pregnancy infections in the five years before pregnancy and use this to define exposure based on frequency and timing of infections in relation to onset of pregnancy and a cumulative load of infection. Gestational age at delivery and groups categorised by term of delivery (e.g. very/moderately preterm) will be compared between women with pre-pregnancy infections and those without, and will be adjusted as appropriate for sociodemographics (e.g., age, smoking, BMI, socioeconomic deprivation), pregnancy factors (e.g., parity, fetal and labour factors such as sex and mode of delivery) and clinical factors (e.g., pre-existing and gestationally presenting comorbidities). Groups will also be compared by other relevant exposure groupings according to the patterns of pre-pregnancy infections (e.g. frequency and timing). Cluster analysis will be used to account for women contributing more than one study pregnancy.
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Comparative Effectiveness of Umeclidinium + Vilanterol versus Inhaled corticosteroids + long- acting beta-agonists as inhaled maintenance therapy among patients with Chronic Obstructive Pulmonary Disease in a UK real-world primary care setting — Alexandrosz Czira ...
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Comparative Effectiveness of Umeclidinium + Vilanterol versus Inhaled corticosteroids + long- acting beta-agonists as inhaled maintenance therapy among patients with Chronic Obstructive Pulmonary Disease in a UK real-world primary care setting
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-29
Organisations:
Alexandrosz Czira - Chief Investigator - GSK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Catherine Castillo - Collaborator - Adelphi Real World
Eunmi Ha - Collaborator - Adelphi Real World
Gema Requena - Collaborator - GlaxoSmithKline - UK
Jie Yeap - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Medication adherence (PDC â¥80%); time to triple therapy use (single or multiple inhaler triple therapy); time to first on-treatment AECOPD (moderate-to-severe, moderate, severe); HCRU (all-cause and COPD-related); Direct medical costs (all-cause and COPD-related); Mean number of rescue medication prescriptions per patient (inhaled or nebulised short-acting muscarinic agonists [SAMA] or short-acting β2-agonists [SABA] containing medications)
Description: Technical Summary
Aim: To conduct a head-to-head comparative effectiveness study of single inhaler Umeclidinium/Vilanterol (UMEC/VI) (a once-daily long-acting muscarinic antagonist [LAMA]/long-acting β2-agonist [LABA]) versus single inhaler twice-daily inhaled corticosteroid (ICS)/LABAs in a COPD General Practice cohort in England. Greater understanding of the effectiveness of these initial maintenance therapy options will better-inform early treatment choices for patients with COPD in the UK.
Objectives: To compare i) medication adherence; ii) time-to-triple therapy; iii) time-to-first acute exacerbation of COPD; iv) all-cause and COPD-related healthcare resource utilisation (HCRU) and direct medical costs among COPD patients newly initiating UMEC/VI versus ICS/LABAs (also beclomethasone/formoterol fumarate [BDP/FF] - one of the currently available twice-daily ICS/LABAs). The mean number of rescue medications prescribed per patient will also be reported.
Primary exposures: Single inhaler UMEC/VI or ICS/LABAs (also BDP/FF) initiation.
Primary outcome: Medication adherence 12 months post therapy initiation.
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) to assess UMEC/VI versus ICS/LABAs (also BDP/FF) efficacy using linked CPRD Aurum and Hospital Episode Statistics (HES) data. The earliestearliest date of therapy initiation between July 2014 and September 2019 will determine the index date. No minimum follow-up is required for study inclusion; a 24 months maximum follow-up will be used to assess study outcomes.
Data analysis: A propensity score (PS) method will be implemented to minimise potential confounding and evaluate average effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Adherence will be classified using proportion of days covered (PDC): PDC<80% considered non-adherent, PDCâ¥80% adherent. Time-to-triple therapy and COPD exacerbations will be assessed using Kaplan-Meier survival analysis and Cox proportional hazards models. HCRU and costs (derived via application of unit costs/tariffs) will be compared using IPTW-weighted RRs from negative binomial regression and relative rates from generalised linear models respectively.
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Impact of COVID-19 vaccination on preventing long COVID: a population-based cohort study using linked NHS data — Daniel Prieto...
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Impact of COVID-19 vaccination on preventing long COVID: a population-based cohort study using linked NHS data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-09
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Annika Jodicke - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University Hospitals
Junqing Xie - Collaborator - University of Oxford
Kristin Kostka - Collaborator - University of Oxford
Martà Català Sabaté - Collaborator - University of Oxford
Trishna Rathod-Mistry - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of Oxford
Xintong Li - Collaborator - University of OxfordOutcomes:
WP1A: Diagnoses/symptoms characterising long COVID, which were recorded >28days after a positive test/clinical diagnosis of COVID-19 in CPRD;
WP1B: A first positive test/clinical diagnosis of COVID-19 recorded in the first 10 days after the first dose of a covid vaccine;
WP2 and WP3: Long COVID;Description: Technical Summary
BACKGROUND
While many people fully recover after COVID-19, a substantial proportion continues to suffer from long-term
complications. While vaccines have shown impressive efficacy to prevent severe COVID-19, their impact on long COVID is not investigated in ongoing trials.OBJECTIVES
1) To test if the proposed observational analyses adequately account for confounding.
2) To evaluate the impact of covid vaccination on the prevention of long COVID.
3) To evaluate the comparative effectiveness of covid vaccines to prevent long COVID.METHODS
Data: NHS records from CPRD GOLD and AURUM, linked to HES inpatient data, Index of Multiple Deprivation and publicly available regional infection/vaccination rates.
Participants: All adults registered in CPRD GOLD/AURUM for >180 daysWP1:
a) To characterise long COVID in CPRD based on a positive test/clinical diagnosis with persistent symptoms
for >28 days. Relevant symptoms will be defined based on a systematic literature review.
b) To emulate the null effect of vaccines to prevent COVID-19 in the 10 days after first dose. To test this, 4 staggered
cohort studies will be conducted, with eligibility criteria based on vaccination priority groups. Cohort-specific
propensity score (PS) will be estimated, and PS-weighted Poisson models fitted to calculate rate ratios (RR) for
COVID-19 in the 10 days after first dose. Negative control outcomes will be used to calibrate for residual
confounding.WP2:
To estimate the effect of vaccines on the development of long COVID (as defined in WP1a) by comparing vaccinated vs. unvaccinated persons using the study design âvalidatedâ in WP1b and cox regression. Sensitivity analyses considering e.g. different long COVID definitions will be conducted.WP3:
To study the comparative effectiveness of Oxford/AstraZeneca vs BioNTech/Pfizer vaccine to prevent long COVID using the methods in WP1b/WP2.PUBLIC HEALTH BENEFIT:
Understanding the impact vaccination has on preventing long COVID will inform future risk-benefit evaluations for COVID vaccines.
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Incretin-based drugs and the risk of acute liver injury among patients with type 2 diabetes mellitus — Samy Suissa ...
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Incretin-based drugs and the risk of acute liver injury among patients with type 2 diabetes mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-19
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Acute liver injury identified by using Read and SNOMED-CT codes as well as a liver-enzyme based definition in CPRD,1, 2 and ICD-10 codes3 in HES and ONS (definitions in Appendix 1).
Description: Technical Summary
We propose to conduct a study to assess whether the use of incretin-based drugs, in comparison with the use of SGLT-2 inhibitors, antidiabetic drugs used at a similar stage in the disease, is associated with an increased risk of acute liver injuries among patients with type 2 diabetes mellitus. We will assemble a cohort of patients, at least 18 years of age, who initiated incretin-based drugs or SGLT-2 inhibitors from 1 January 2013 (the year of availability of the comparator drugs in the United Kingdom) until 31 December 2019, with follow-up until March 31, 2020. Propensity scores will be computed to determine the predicted probability of treatment with GLP-1 RAs or DPP-4 inhibitors versus SGLT-2 inhibitors. Cox proportional hazards models with propensity score fine stratification weighting will then be used to estimate hazard ratios of acute liver injury, separately for GLP-1 RAs and DPP-4 inhibitors. Secondary analyses will be conducted to determine whether there is a duration-response relation, association with individual drugs, and whether the association varies by age, sex, and use of hepatotoxic drugs. Given the relatively high prevalence of type 2 diabetes, our study will address an important safety concern regarding the commonly used drugs in this patient population.
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Opioid prescriptions following discharge from hospital after abdominal and orthopaedic surgery: A cohort study from England — Roger Knaggs ...
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Opioid prescriptions following discharge from hospital after abdominal and orthopaedic surgery: A cohort study from England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-29
Organisations:
Roger Knaggs - Chief Investigator - University of Nottingham
Reham Baamer - Corresponding Applicant - University of Nottingham
David Humes - Collaborator - University of Nottingham
Dileep Lobo - Collaborator - University of Nottingham
Li Shean Toh - Collaborator - University of NottinghamOutcomes:
C. Outcomes to be Measured
1. The characteristics of the first opioid prescription received from primary care in the first 30 days following selected orthopaedic and abdominal surgical procedures. Including the type, formulation, and amount of the opioid;
2. Time to opioid discontinuation in days following selected orthopaedic and major abdominal surgical procedures;
3. Predictors affecting time to opioid discontinuation following selected orthopaedic and major abdominal surgical procedures.Description: Technical Summary
In England, hip and knee replacement are the second and third most common surgeries, with 115,758 and 81,590, respectively, performed in 2014.[1] Abdominal surgical procedures such as cholecystectomy are the following most common procedures. While short-term opioid use has an established role in managing acute pain following these surgeries[2], prolonged use is linked with opioid-related harms and opioid diversion.[3, 4] In the UK, the type, amount, and formulation of opioids commonly prescribed by general practitioners following discharge after surgery, the timing of opioid cessation following surgery and the risk factors associated remain unexplored. Therefore, the findings from this research will inform clinical practice guidelines to tailor postoperative pain management plans to avoid unnecessarily prolonged opioid use.
The repeated cross-sectional analysis aims to describe the characteristics of the first opioid prescription received following surgery discharge date. Patients with codes for one of four selected surgical procedures; (colectomy, cholecystectomy, total hip arthroplasty or total knee arthroplasty) and available for linkage to HES and have an opioid prescription from their General Practitioner within 30 days from discharge will be included. Descriptive statistics will be used to report opioid utilisation measures each year and stratify patients into opioid naïve and prior opioid exposed groups. Linear trend analysis will be conducted on annual opioid utilisation measures, and the percentage change between 2011 and 2020 data for variables will be reported.
A cohort design will be used to identify time-to-discontinuation of opioids in days with follow up occurring over 12 months from the discharge date. Time to opioid discontinuation will be defined as 90 days opioid-freeâno current or prior opioid prescription covered those 90 days. Kaplan-Meier survival curves will be used to graph time to discontinuation. Then patient factors affecting time to opioid discontinuation will be identified using cox proportional hazard models to estimate hazard ratios.
Source -
Determining patients at risk of first Chronic Obstructive Pulmonary Disease (COPD) exacerbation in UK Global Initiative for Chronic Obstructive Lung Disease (GOLD) A and B Chronic Obstructive Pulmonary Disease (COPD) patients — Kieran Rothnie ...
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Determining patients at risk of first Chronic Obstructive Pulmonary Disease (COPD) exacerbation in UK Global Initiative for Chronic Obstructive Lung Disease (GOLD) A and B Chronic Obstructive Pulmonary Disease (COPD) patients
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-02
Organisations:
Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Beade Numbere - Corresponding Applicant - GSK
Afisi Ismaila - Collaborator - GSK
Steve Gelwicks - Collaborator - GlaxoSmithKline - USA
Yifei Lu - Collaborator - GlaxoSmithKline - UKOutcomes:
⢠Number of any moderate/severe exacerbations
⢠Number of moderate exacerbations
⢠Number of severe exacerbations
⢠Moderate/Severe Exacerbations in 1 year follow up period
⢠Moderate/Severe Exacerbations in 3 year follow up period
⢠Moderate/Severe Exacerbations in 5 year follow up periodDescription: Technical Summary
Overarching aim and objectives: To identify risk factors which contribute to a first Chronic Obstructive Pulmonary Disease (COPD) (moderate, moderate/severe exacerbation and severe) exacerbation in UK Global Initiative for Chronic Obstructive Lung Disease (GOLD) A and B COPD patients overall, and by inhaled corticosteroid use at baseline. Study population of interest: GOLD A and B COPD UK patients from the linked Clinical Practice Research Datalink (CPRD) Aurum and Hospital Episode Statistics (HES) data. Primary exposures and outcome: Forced expiratory volume in one second (FEV1)% predicted, Medical Research Council (MRC) dyspnea scale, COPD Assessment Test (CAT) score, COPD GOLD grade of airflow limitation, GOLD 2020, moderate-severe Acute exacerbation of COPD (AECOPD) history, eosinophil levels, comorbidities, current asthma diagnosis, historical asthma diagnosis. Outcomes include risk of moderate, severe, moderate/severe exacerbations in 1 year, 3 year and 5 year follow up period. Data sources: CPRD-AURUM will be used to capture the majority of a patientâs COPD healthcare journey. HES (Admitted Patient Care) will be used to determine COPD patients that experience severe (hospitalised) events. Patient Level Index of Multiple Deprivation will be used to describe the baseline socioeconomic status of COPD patients and to enable adjustment for it. Study design, methods (statistical tests): A retrospective cohort study using CPRD Aurum linked to HES with follow up period from Jan 2013 to Dec 2019. A cox proportional hazards regression will be used to examine the association between the primary exposure variables and the risk of the first exacerbation, up to 5 years of follow up from the index in GOLD A and B COPD patients. Intended public health benefit of the research: This research will better inform clinicians on identifying COPD patients with a high risk of a first exacerbation outcome and aid clinicians to know where early optimisation efforts may be best targeted.
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The impact of COVID-19 on heart failure epidemiology and outcomes across primary care: a population-based cohort study — Theresa McDonagh ...
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The impact of COVID-19 on heart failure epidemiology and outcomes across primary care: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-30
Organisations:
Theresa McDonagh - Chief Investigator - King's College London (KCL)
Antonio Cannata - Corresponding Applicant - King's College London (KCL)
Daniel Bromage - Collaborator - King's College London (KCL)Outcomes:
We will measure for each of the time frames:
1. Incidence and prevalence of HF
2. Aetiology of HF
3. Quality of care for both incident and prevalent HF (i.e. the proportion of patients having âessential diagnostic testsâ and the average time-to-optimization of medical therapy for those with incident HF).
4. All-cause mortality, cardiovascular mortality, hospitalization rates for both incident and prevalent HF in each of the three time periods. We will also examine the association between the above Quality of Care Indicators, and mortality and readmission rates.Description: Technical Summary
Heart failure (HF) affects approximately 2% of the general population and up to 10% of the elderly. It is associated with high mortality and morbidity and consumes over 2% of the entire NHS budget. The COVID-19 pandemic has had a massive impact on healthcare systems and the delivery of care. These changes led to a reduction of hospitalizations for heart failure, paralleled by increased mortality. The increased HF mortality during the peak of the SARS-CoV2 pandemic necessitates further research to understand its underlying reasons so that they can be mitigated in the future.
We will interrogate complementary, national, linked data sources to ascertain changes the year before, the years during and the year after the SARS-CoV2 pandemic. We will use de-identified individual patient data from key national datasets: The Clinical Practice Research Datalink (CPRD) to obtain information on primary care, the Hospital for Episode Statistics (HES) for hospitalizations, and the Office for National Statistics (ONS) for mortality.
We will link information of approximately 100,000 patients with HF to determine the changes that occurred during the COVID-19 pandemic and compare them to before and after the SARS-CoV2 pandemic to describe the epidemiology of HF during COVID-19 as well as the changes observed in the quality of care and outcomes.
We will use standard descriptive statistics to compare baseline clinical characteristics. Incidence rates of HF hospitalizations will be calculated, and incidence rate ratios (IRR) will be compared using Poisson regression. Cumulative incidence curves for adverse events (i.e. all-cause mortality and HF hospitalization) will be estimated and compared between groups using the Log-rank test. Cox proportional hazard models will be estimated to assess the prognostic significance of the parameter analysed.
Source -
Severe mental illness (SMI) and cancer screening inequalities: a cross section study — Alex Jones ...
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Severe mental illness (SMI) and cancer screening inequalities: a cross section study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-17
Organisations:
Alex Jones - Chief Investigator - Office for Health Improvement and Disparities
Gabriele Price - Corresponding Applicant - Office for Health Improvement and Disparities
Cam Lugton - Collaborator - Office for Health Improvement and Disparities
Danny Yip - Collaborator - Office for Health Improvement and Disparities
Jianhe Peng - Collaborator - Office for Health Improvement and Disparities
Robert Kerrison - Collaborator - University of SurreyOutcomes:
The study will include both descriptive and analytical components, and each will measure slightly different outcomes.
Descriptive statistics:⢠The proportion (with confidence intervals) of adults with and without SMI (separately) who had participated in bowel, breast and cervical screening (separately) in the period up to September 2020, split by:
o Index of multiple deprivation (IMD) quintile
o Patient ethnicity
o Region of England of the GP practice where the patient was registered
o Smoking status (current smoker or not)
o BMI status (greater or less than 30)
o Age group (for cervical screening)
o Gender (for bowel screening)
o Alcohol and drug consumption may also be considered⢠The proportion (with confidence intervals) of adults who had participated in bowel, breast and cervical screening (separately) in the period up to September 2020 split by category of SMI (bipolar disorder, psychosis, schizophrenia or no SMI)
⢠The proportion of females aged between 60 and 64 who had participated in 0, 1, 2 or all three of the screening programmes
⢠The number of females age between 50 and 64 who had participated in 0, 1 or both of breast and cervical screening
⢠The number of females aged between 60 and 70 who had participated in 0, 1 or both of bowel and breast screening
Analytical statistics:
Multiple logistic regression models will be used to measure:
⢠Participation in bowel screening
⢠Participation in breast screening
⢠Participation in cervical screeningThe outcomes will be summarised and presented by their odds. Odds ratios and their confidence intervals will be estimated for participation given a diagnosis of bipolar disorder, psychosis and schizophrenia respectively against a reference category of no SMI.
Odds ratios and confidence intervals will also be estimated for each of the additional confounding variables.
Amendments - 10/11/21
Review Comments: Please clarify your definition of psychosis (for example, will drug-induced psychosis be included?).
Research team response: Non-affective psychosis diagnostic codes will be included. Therefore we excluded conditions such as organic psychoses or drug- induced psychoses.
Optionally: consider truncating at March 2020, instead of September 2020, to avoid confounding by the covid epidemic.
Research team response: Thank you for this comment. The analysis includes 6 months period in addition to the standard recall period for each cancer screening programme which will allow for some delay due to pandemic restrictions. We expect that the impact of pandemic on access to cancer screening will apply to the SMI and non-SMI. We will compare our cancer screening participation rates with what would be expected and caveat our results accordingly.
Description: Technical Summary
Adults with SMI are twice as likely as adults without SMI to die with cancer before their 75th birthday. (1). It has been suggested that this inequality is contributed to by reduced uptake of cancer screening services, delayed cancer diagnosis, treatment choices and adherence to treatment plans. (2â7)
Clinical Practice Research Datalink (CPRD) Aurum data will be used to explore associations between cancer screening, SMI diagnoses and a range of person, place and behaviour related variables in England. It will also be used test the null hypotheses that people in England with different SMIs are as likely as people without SMI to participate in cancer screening services, once other non-SMI factors are adjusted for. The analysis will be conducted on a cross section of data from September 2020.
The hypothesis tests will be completed using three multiple logistic regression models. The outcome variables will be participation in bowel, breast and cervical screening. The primary exposure variable will be a previous diagnosis of SMI (split into three categories of SMI, and a reference category of no SMI). Models will be constructed separately for bowel, breast and cervical screening. Three categories of confounding variables will be added to each model: person based (age, gender and ethnicity), place based (deprivation and region) and healthy behaviour based (smoking status and body mass index (BMI)). Alcohol and drug consumption may also be considered. Null hypotheses will be rejected where the confidence intervals around the SMI diagnosis coefficients do not overlap with 1.
This research may contribute to improved cancer screening services and health outcomes for adults with SMI. If the null hypotheses are rejected, it offers adequate evidence that merely targeting non-SMI characteristics is unlikely to fully address the SMI based inequalities. It would provide an evidence-based justification for SMI targeting of the screening services.
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Comparative effectiveness of Umeclidinium + Vilanterol versus Indacaterol + Glycopyrronium bromide assessing exacerbation frequency, costs and resource-use among patients with Chronic Obstructive Pulmonary Disease in a UK real-world primary care setting — Gema Requena ...
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Comparative effectiveness of Umeclidinium + Vilanterol versus Indacaterol + Glycopyrronium bromide assessing exacerbation frequency, costs and resource-use among patients with Chronic Obstructive Pulmonary Disease in a UK real-world primary care setting
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-19
Organisations:
Gema Requena - Chief Investigator - GlaxoSmithKline - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Catherine Castillo - Collaborator - Adelphi Real World
Eunmi Ha - Collaborator - Adelphi Real World
Jie Yeap - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Rate of AECOPD (moderate-to-severe, moderate, severe); time to first AECOPD (moderate-to-severe, moderate, severe); HCRU (all-cause and COPD-related); Direct medical costs (all-cause and COPD-related); proportion of patients receiving triple therapy; Time-to-triple therapy
Description: Technical Summary
Aim: To compare real-world effectiveness of Umeclidinium/Vilanterol (UMEC/VI) versus Indacaterol/ Glycopyrronium bromide (IND/GLY) on acute exacerbations of COPD (AECOPD) and health care resource utilisation (HCRU) and direct medical costs, among a General Practice (GP) chronic obstructive pulmonary disease (COPD) cohort in England.
Objectives: To compare i) rate of moderate-to-severe AECOPD (also moderate and severe separately); ii) time to first on treatment AECOPD (moderate-to-severe, moderate, severe) and iii) all-cause and COPD-related HCRU/ direct medical costs, among COPD patients newly initiating dual therapy with single inhaler UMEC/VI versus IND/GLY. Uptake of triple therapy will also be described (proportion of patients receiving single- or multiple-inhaler triple therapy [(SITT or MITT]) and time until triple therapy initiation).
Primary exposures: Single inhaler UMEC/VI or IND/GLY initiation.
Primary outcomes: Rate of moderate-to-severe AECOPDs
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) to adjust for measured confounders to assess the non-inferiority of UMEC/VI versus IND/GLY using linked CPRD Aurum and Hospital Episode Statistics (HES) data. In the event that non-inferiority is demonstrated, superiority will then be examined. The first/earliest date of dual therapy (UMEC/VI or IND/GLY) initiation between January 2015 and September 2019 will determine the index date. No minimum follow-up is required for inclusion into the study.Data analysis: A propensity score (PS) method will be implemented to minimise potential confounding and evaluate average effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Rate of AECOPDs (events per person-year) will be compared using IPTW-weighted rate ratios (RRs) from negative binomial regression. HCRU and costs (derived via application of unit costs/tariffs) will be compared using IPTW-weighted RRs from negative binomial regression and relative rates from generalised linear models, respectively. Time-to-triple therapy will be assessed using Kaplan-Meier survival analysis and Cox proportional hazards models.
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Frequency of migraine and the use of preventive medication in a UK primary care population — Julie Mount ...
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Frequency of migraine and the use of preventive medication in a UK primary care population
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-24
Organisations:
Julie Mount - Chief Investigator - Eli Lilly & Co - UK
Julie Mount - Corresponding Applicant - Eli Lilly & Co - UK
Andrew Pain - Collaborator - Eli Lilly & Co - UK
Camilla Kristine Appel - Collaborator - Eli Lilly & Co - UK
david kernick - Collaborator - NHS DEVON CCG
Michael Ranopa - Collaborator - Eli Lilly and Company Ltd. (UK)
Tania Gulati - Collaborator - Eli Lilly & Co Ltd - US HeadquartersOutcomes:
⢠Migraine
⢠Migraine preventive medication use
⢠Age
⢠Gender
⢠BMI
⢠Region
⢠Referral to neurologistDescription: Technical Summary
Recent data on the epidemiology of migraine in the UK is scarce. The intention of this study is to provide reliable, current data on the epidemiology and treatment patterns of migraine in the adult UK population treated by general practitioners (GPs) focusing mainly on the prevalence of the population who have ceased at least 3 oral migraine preventive classes.
This is an observational study using data from the CPRD with cross-sectional prevalence assessment (1 Jan 2020), one year cumulative incidence assessment (1 Jan 2019 to 31 Dec 2019) and longitudinal preventive treatment patterns assessment (12 Sep 2012 to 1 Jan 2020).
Numerator and denominator populations for the prevalence and cumulative incidence of migraine calculations and study cohorts for the longitudinal assessment of migraine preventive treatment patterns will be identified from the total CPRD population. Migraine will be ascertained through history of Read codes and preventive medications will be identified using medication codes.
Study variables include migraine, preventive medications (name and duration), age, gender, BMI, region, and referral to neurologist.
The statistical analysis in the study will be descriptive. Prevalence and cumulative incidence calculations will be reported as n/1,000 (95% CI). Treatment patterns will be tabulated and illustrated using a histogram and Sankey diagram. Patient characteristics and frequency of referrals will be described using standard univariate descriptive statistics.
This study will generate evidence on the prevalence of adult migraine in a UK primary care population.
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Safety and tolerability of osteoporosis treatments in women — Susan Jick ...
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Safety and tolerability of osteoporosis treatments in women
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-25
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Zarena Jafry - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Safety outcomes: Atypical femoral fractures (AFF); osteonecrosis of the jaw (ONJ); any osteonecrosis; stroke; myocardial infarction; atrial fibrillation; venous thromboembolism; superficial thrombophlebitis; osteosarcoma; esophageal cancer; liver cancer; acute renal toxicity; allergic/hypersensitivity reactions; skin reactions; hypercalcemia; hypocalcemia; severe musculoskeletal pain; opportunistic infection; any infection
Tolerability outcomes: gastrointestinal irritation (nausea/vomiting); Acute flu-like reactions (aches, pain, fever); hormonal symptoms (hot flashes, leg cramps, vaginal discharge/postmenopausal bleeding)
Description: Technical Summary
More than 2.5 million women in the UK are at risk for osteoporotic fractures and may benefit from treatment to prevent these fractures from occurring. The objective of this cohort study is to describe the safety and tolerability of treatments for the prevention of osteoporotic fracture among women in the UK. We will select all females aged 40 and older, who are new users of bisphosphonates, denosumab, teriparatide, raloxifene, tibolone or calcitonin in the years 2000 through 2020 in CPRD GOLD and CPRD Aurum. We will also select female users of vitamin D aged 40 or older with codes for osteoporosis/osteopenia/monitoring. We will then assess the feasibility of capturing cases of atypical femoral fractures and osteonecrosis of the jaw using information in the primary care and linked hospital records (HES APC). Additional outcomes will include major cardiovascular events, acute renal toxicities, osteosarcoma, esophageal cancer, liver cancer, gastrointestinal irritation, hypersensitivities, hyper/hypocalcemia, and infections. Using Byarâs method, we will estimate incidence rates, for each outcome, for each study drug, past use of any osteoporosis treatment or vitamin D only. Using Poisson regression, we will estimate incidence rate ratios for each outcome by study drug compared to the comparator group. For acute outcomes the comparator group will include both vitamin D only users and past users of osteoporosis treatments while for outcomes with delayed effects, such as cancer, the comparator will include vitamin D users only. Incidence rates and incidence rate ratios will be stratified by data source (GOLD vs Aurum), age, calendar time, disease severity, and concomitant use of corticosteroids and/or hormone replacement therapy. The results of this study will provide valuable data to clinicians to help inform patients choosing between treatment options. They will also provide important information for future studies related to the safety and tolerability of treatments for osteoporosis.
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Real-world comparative effectiveness of Fluticasone Furoate+Umeclidium+Vilanterol versus multiple inhaler triple therapies among patients with Chronic Obstructive Pulmonary Disease in the United Kingdom — Kieran Rothnie ...
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Real-world comparative effectiveness of Fluticasone Furoate+Umeclidium+Vilanterol versus multiple inhaler triple therapies among patients with Chronic Obstructive Pulmonary Disease in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-29
Organisations:
Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Lucinda Camidge - Collaborator - Adelphi Real World
Monica Seif - Collaborator - Adelphi Real World
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real WorldOutcomes:
Rate of AECOPD (moderate-to-severe, moderate, severe); HCRU (all-cause and COPD-related); Direct medical costs (all-cause and COPD-related).
Description: Technical Summary
Aim: To assess the impact of initiating triple therapy with single inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) versus multiple inhaler triple therapy (MITT) by comparing rate of acute exacerbations of chronic obstructive pulmonary disease (AECOPDs), healthcare resource utilisation (HCRU) and medical costs among COPD patients in a General Practice cohort in England. Greater understanding of the effectiveness of these therapies will better-inform treatment choice for patients with COPD.
Objectives: To compare i) rate of moderate-to-severe AECOPDs (also moderate and severe separately); ii) all-cause and COPD-related HCRU and direct costs among COPD patients newly initiating triple therapy with MITT versus single inhaler FF/UMEC/VI. Rate of moderate-to-severe AECOPDs (also moderate and severe separately) will also be evaluated in COPD patients newly initiating triple therapy (MITT versus single inhaler FF/UMEC/VI) with and without a diagnosis of comorbid asthma.
Exposures: Single inhaler FF/UMEC/VI and MITT initiation
Outcomes: Rate of AECOPDs (moderate-to-severe; moderate; severe); HCRU; Direct medical costs
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) to adjust for measured confounders to assess the superiority of single inhaler FF/UMEC/VI versus MITT using linked CPRD Aurum and Hospital Episode Statistics (HES) data. The first/earliest date of triple therapy (MITT or single inhaler FF/UMEC/VI) initiation between 15th November 2017 and 30th September 2019 will determine the index date. The minimum required follow-up is 6 months.
Analysis: A propensity score (PS) method will be implemented to minimise potential confounding and evaluate average effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Rate of AECOPDs (events per person-year) will be compared using weighted rate ratios (RRs) from negative binomial regression. HCRU and costs (derived via application of unit costs/tariffs) will be compared using weighted RRs from negative binomial regression and relative rates from generalised linear model, respectively.
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Epidemiology of shoulder pain and associated risk factors in the United Kingdom: a population-based study of UK primary care data using clinical practice research datalink (CPRD). — Michelle Hall ...
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Epidemiology of shoulder pain and associated risk factors in the United Kingdom: a population-based study of UK primary care data using clinical practice research datalink (CPRD).
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-23
Organisations:
Michelle Hall - Chief Investigator - University of Nottingham
Nouf Alotaibi - Corresponding Applicant - University of Nottingham
Barbara Iyen - Collaborator - University of Nottingham
Michael Doherty - Collaborator - University of Nottingham
Subhashisa Swain - Collaborator - University of Oxford
Weiya Zhang - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Primary outcomes :
1- The current prevalence and incidence of shoulder pain in the UK, overall, by age, sex, and regions. We will use 2019 data to present the current prevalence and incidence to avoid the bias due to the COVID-19 pandemic.
2- The risk factors associated with shoulder pain.
Secondary outcomes:
3- The outcomes of shoulder pain.
We will determine the number of GP consultations per year, the frequency of hospitalisations per year and all-cause mortality. We will also examine the incidence of comorbidities and their relative risk in people with shoulder pain versus those without.
4- Types of shoulder pain and their prevalence and incidence in 2019.
The prevalence of different diagnostic codes for shoulder pain in the year 2019 will be examined.- The following pathoanatomical classification system of shoulder disorders has been widely used in clinical practice (1): rotator cuff; biceps tendon; adhesive capsulitis; glenohumeral arthritis; acromioclavicular joint abnormalities.
- A nonâspecific shoulder pain category is also frequently found in the general population and clinical practice due to the lack of a consistent standardised diagnostic approach for the shoulder (1).
- The diagnosis of shoulder disorders in the primary care (the Guidelines on referral and treatment ) in the NHS is described in Appendix 15- The trends of shoulder pain in the past 21 years (2000 â 2020)
We will report the prevalence and incidence each year and examine the trend from 2000 to 2020. We will include 2020 data to examine the impact of the pandemic/lockdown on shoulder pain.Description: Technical Summary
This project aims to determine the prevalence and incidence, risk factors, and outcomes of shoulder pain from 2000 to 2020.
Prevalence and incidence rates in 2019 will be used to present the current disease burden as 2020 estimates may be unrepresentative due to the COVID pandemic. Age, sex and geographic distribution, and trends in prevalence and incidence from 2000-2020 will be examined. We will undertake a case-control study to examine risk factors. Incident cases of shoulder pain will be identified between 2000 and 2020 (first diagnosis date as index date). Each will be matched with a control without shoulder pain by age, sex, and practice at the index date. We will compare risk factors such as alcohol, smoking, body mass index (BMI), ethnicity and socioeconomic status between cases and controls by the index date retrospectively. A logistic regression model will be used to estimate odds ratios.
We will then undertake a cohort study to follow up the cases and controls from the index date for the outcomes of interest including number of general practitioner (GP) consultations and hospitalisations per year, comorbidities, and all-cause mortality. For comorbidity, people at risk of a specific comorbidity of interest will be followed up. For example, diabetes at the index date will be excluded in order to capture incident diabetes. The Cox regression model will be used for this analysis. Hospital episode statistics (HES) will be used to determine hospitalisations. Office for National Statistics (ONS) death registration data will be used for estimating all-cause mortality.This research will increase understanding of the burden of shoulder pain in the UK, potential use of health resources because of shoulder pain and its comorbidities. It will also inform early intervention strategies for people at higher risk of comorbidity.
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Fractures Associated with Corticosteroids for Eczema Treatment (FACET) — Sinead Langan ...
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Fractures Associated with Corticosteroids for Eczema Treatment (FACET)
Datasets:GP data, HES Admitted Patient Care; Patient Level Carstairs Index; Practice Level Carstairs Index (Excluding Northern Ireland)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-17
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Julian Matthewman - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Patterns of OCS use; Fracture preventive care (prescriptions for anti-osteoporosis medications); Major osteoporotic fractures (hip, spine, wrist, and pelvis)
Description: Technical Summary
Background: Atopic eczema, a common skin disease characterised by itching and rash, is sometimes treated with oral corticosteroids (OCS). It is well established that OCSs increase fracture risk. Fracture-preventive care medications, like bisphosphonates, can be used to counter OCSâ negative effects on bone health.
People with atopic eczema are prescribed OCSs in different patterns (e.g., continuously or intermittently). We hypothesise that people given intermittent courses of OCSs are less likely to receive adequate fracture-preventive care than people receiving the same cumulative corticosteroid dose continuously, leading to a shortfall in preventive care.
Objectives: We will: 1) describe patterns of OCS use in people with atopic eczema; 2) compare rates of fracture preventive care between intermittent and continuous OCS users in people with atopic eczema who receive high cumulative doses of OCS; 3) compare rates of fractures between intermittent and continuous OCS users in high-cumulative-OCS-dose users with atopic eczema.
Methods: We will initially describe characteristics and patterns of OCS use in adults (18+) with atopic eczema. In older people (>=66 years, bisphosphonate prescribing uncommon in younger people) receiving high cumulative doses of OCS (i.e., >450mg prednisolone equivalent dose within 6 months), we will use Cox regression to estimate hazard ratios, comparing rates of fracture-preventative care and fractures in people with intermittent-OCS use compared to continuous-OCS users. All analyses will be adjusted for potential confounders.
Relevance: If there is a difference in fracture-preventive-care receipt between people on intermittent versus continuous OCS, our results will highlight a gap in appropriate care and inform atopic eczema management.
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A retrospective observational study on the burden of paroxysmal nocturnal haemoglobinuria in England using Hospital Episodes Statistics and the Clinical Practice Research Database — ...
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A retrospective observational study on the burden of paroxysmal nocturnal haemoglobinuria in England using Hospital Episodes Statistics and the Clinical Practice Research Database
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-25
Organisations:
- Chief Investigator -
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Carly Rich - Collaborator - Swedish Orphan Biovitrum AB ( SOBI )
Jameel Nazir - Collaborator - Swedish Orphan Biovitrum AB ( SOBI )
Koo Wilson - Collaborator - Swedish Orphan Biovitrum AB ( SOBI )
Laura Tolan - Collaborator - OPEN Health Group
Mark Evans - Collaborator - OPEN Health Group
Myriam Alexander - Collaborator - OPEN Health Group
Stephen Boult - Collaborator - Harvey Walsh Ltd
Zalmai Hakimi - Collaborator - Swedish Orphan Biovitrum AB ( SOBI )Outcomes:
Age; sex; index of multiple deprivation; ethnicity; Charlson Comorbidity Index; weight; smoking status; co-morbidities and symptoms (tiredness; haemoglobinuria; abdominal pain; shortness of breath / dyspnoea; major adverse vascular event / thrombosis; dysphagia; erectile dysfunction; anaemia including aplastic anaemia; myeloblastic syndrome; immunosuppression in solid organ transplantation; disorder of iron metabolism; amyloid A amyloidosis; multiple myeloma), treatment (red blood cell transfusions; folic acid prescriptions; iron tablets prescriptions; anti-coagulant treatments; C5 complement inhibitor treatment; iron-chelation therapy; hematopoietic stem-cell transplant (HSCT)); full blood counts tests and results including serum iron levels; death; primary and secondary healthcare resource use HCRU (general practitioner contacts; outpatient visits and departments; elective and non-elective inpatient diagnoses, spells and length of stay; Accident and Emergency department attendance) and associated HCRU cost.
Description: Technical Summary
PNH is a rare genetic hematological disorder due to hematopoietic stem-cell dysregulations and symptomatically associated with haemolytic anaemia, thrombosis and peripheral blood cytopenias. Hematopoietic stem-cell transplant is a curative but risky procedure, and treatment with monoclonal antibody C5 complement inhibitors eculizumab (available since 2007 in the United Kingdom ) and ravulizumab (since 2021) are main alternatives. Due to PNH rarity, there remains a paucity of evidence in England on patientsâ characteristics, treatment patterns, and burden placed on the NHS in terms of primary and secondary healthcare resource use. In this context, we undertake a study firstly to better characterise the adult PNH patient population in terms of demographics and clinical characteristics at the time of diagnosis and also post-diagnosis; and also secondly to describe patientsâ treatment patterns, mortality and healthcare resource use (HCRU) in primary and secondary care settings. As evidence is specifically lacking in patients treated with C5 complement inhibitors, the objectives of the study will be undertaken separately in patients receiving / not receiving this treatment following diagnosis. The following information will be extracted: demographic characteristics, comorbidities and symptoms (from HES and CPRD); primary care diagnoses, weight, smoking status, and visits (from CPRD); diagnoses, HCRU (inpatient, outpatient and Accident & Emergency attendances), high-cost drug treatment in secondary care settings and death date (from HES-ONS). This study will be descriptive, reporting summary statistics of frequencies and percentages for categorical variables and means (attendances and associated costs per patient-year for HCRU), standard deviations, medians, interquartile ranges, and range for continuous variables; with 95% confidence intervals to be derived for proportions and means, whenever appropriate. Survival rates will be summarised using Kaplan-Meier methodology. These estimates will provide real-word information on the burden of PNH and support assessment of the unmet need in this rare patient population with limited options for treatment.
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Epidemiology of rheumatoid arthritis in the UK — Agustin Cerani ...
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Epidemiology of rheumatoid arthritis in the UK
Datasets:GP data, Incidence of rheumatoid arthritis (RA) in the UK population by year, by age and by gender; prevalence of RA in the UK population by age and by sex in 2020, using medical codes from CPRD GOLD and Aurum.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-22
Organisations:
Agustin Cerani - Chief Investigator - Galapagos ( GLPG )
Agustin Cerani - Corresponding Applicant - Galapagos ( GLPG )
Ali Charkhi - Collaborator - Galapagos ( GLPG )
Andrew Maguire - Collaborator - EpiFocus Ltd
Claus Andersen - Collaborator - Galapagos ( GLPG )
Mona Khalid - Collaborator - Galapagos ( GLPG )
Monia Zignani - Collaborator - Galapagos ( GLPG )
Raymond Schlienger - Collaborator - Galapagos ( GLPG )Outcomes:
Incidence of rheumatoid arthritis (RA) in the UK population by year, by age and by gender; prevalence of RA in the UK population by age and by sex in 2020, using medical codes from CPRD GOLD and Aurum.
Description: Technical Summary
Given the potentially high disease burden of rheumatoid arthritis âRAâ, the objective of this study is to provide the current epidemiology of this disease in the UK. Therefore, we propose that this study will estimate the incidence and prevalence of RA. Yearly, and overall, estimates of incidence will be calculated since 2005 whilst the prevalence will be estimated at the cross-sectional date (31/12/2020); results will be standardised to the UK population (or England and Wales for Aurum). Patient characteristics including comorbidities, comedication and demographics will be estimated at the date of diagnosis (incidence study) and at the cross-sectional date (prevalence study). This study will also provide the distribution of risk factors for cardiovascular events, venous thromboembolism and serious and opportunistic infections given that RA is associated with these harmful outcomes.
Given that both burden and therapeutic options vary by disease severity, this study will also endeavour to classify patients according to disease severity based on available data.
The study will be performed in both CPRD Gold and Aurum and will include HES APC and patient-level Townsend linkages; this will be the first epidemiological study of RA in Aurum and thus will benefit from the wider coverage of the EMIS network.
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Weight Loss and Weight Management in Adults with Type 2 Diabetes - an Electronic Health Record Study. — Shraboni Ghosal ...
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Weight Loss and Weight Management in Adults with Type 2 Diabetes - an Electronic Health Record Study.
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-26
Organisations:
Shraboni Ghosal - Chief Investigator - Keele University
Shraboni Ghosal - Corresponding Applicant - Keele University
James Bailey - Collaborator - Keele University
Kayleigh Mason - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Neil Heron - Collaborator - Keele UniversityOutcomes:
In patients with T2DM or prediabetes:
Primary outcomes: (i) Prescription of orlistat and metformin (ii) change in weight/BMI.
Secondary outcomes: (i) change in HbA1c (ii) change in FPG (iii) change in BP (iv) proportion of patients with BMI <28 kg/m2 and T2DM/prediabetes prescribed orlistat (v) incidence of T2DM (prediabetes only).Description: Technical Summary
The incidence of T2DM is increasing worldwide and treatments that are implementable in primary care could contribute greatly to the prevention/remission of T2DM. Previous studies have shown that weight loss can improve quality of life and help achieve normal blood glucose levels in overweight/obese patients with T2DM/prediabetes. However, weight loss and weight management can be challenging for many using only lifestyle modifications. NICE guidelines for managing diabetes recommend orlistat for reducing weight in patients who are overweight/obese. Side effects may occur within the first 12 weeks of using orlistat and guidelines suggest treatment may be continued beyond 12 weeks only if weight loss since the start of treatment exceeds 5%. The study objectives are to determine: (i) the incidence of orlistat and (ii) metformin prescriptions in patients with incident T2DM/prediabetes in primary care; (ii) if orlistat is prescribed according to NICE guidelines; (iii) whether patient characteristics including body mass index (BMI) and socio-demographics, including linkage to deprivation, are associated with: (a) prescribing of orlistat (b) stopping orlistat early; (iv) the association of orlistat with long term outcomes including weight loss, and reductions in haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and blood pressure (BP). Patients diagnosed with incident T2DM or prediabetes between 1.1.2016 and 31.12.2017, and â¥18 years of age will be included and followed up in their primary care records for 2 years. For each patient, the closest recorded BMI in the baseline period 2 years prior to diagnosis will be identified. First record of receiving orlistat anytime from 12 weeks prior to diagnosis will be extracted. The incidence of orlistat prescribing per 1000 person years at risk with 95% confidence intervals (CIs) will be determined. Multivariable regression models will be fitted to estimate associations of BMI and the other outcomes with prescribing of orlistat in patients with T2DM/prediabetes.
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Quantification of potential undiagnosed Pulmonary Arterial Hypertension (PAH) patients among patients with chronic respiratory disorders and PAH-related cardiovascular conditions through machine learning models in the UK CPRD-HES databases — Eva...
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Quantification of potential undiagnosed Pulmonary Arterial Hypertension (PAH) patients among patients with chronic respiratory disorders and PAH-related cardiovascular conditions through machine learning models in the UK CPRD-HES databases
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-02
Organisations:
Eva-Maria Didden - Chief Investigator - Actelion Pharmaceuticals Ltd
Eva-Maria Didden - Corresponding Applicant - Actelion Pharmaceuticals Ltd
Brenda Reinhart - Collaborator - ZS Associates
Denys Wahl - Collaborator - Janssen-Cilag EMEA
Flora Ashley Daniels - Collaborator - Not from an Organisation
Hammad Shahid - Collaborator - Janssen Pharmaceutica NV
Manish Kumar - Collaborator - ZS Associates
Pratyush Khare - Collaborator - ZS Associates
Prerna Goel - Collaborator - ZS Associates
Sanchita Porwal - Collaborator - ZS Associates
Shaishav Jain - Collaborator - ZS AssociatesOutcomes:
The study has three main outcomes. First, an estimate of the number of undiagnosed PAH patients among patients with chronic respiratory disorders and cardiovascular conditions. Second, understanding the impact of comorbid conditions, demographics, treatments, procedures, or laboratory test values on patient's estimated probability of having PAH. Finally, the model performance metrics including model sensitivity, specificity, and precision-recall curves.
Description: Technical Summary
Pulmonary arterial hypertension (PAH) is a rare disease that often remains asymptomatic in early stages. Affected patients are often un(mis)-diagnosed since the symptomology of PAH is similar to other chronic respiratory or cardiovascular disorders, and the final diagnosis of PAH requires an invasive right heart catheterisation (RHC) to exclude other forms of pulmonary hypertension.
This study aims to develop a machine learning solution to quantify undiagnosed PAH patients amongst patients initially diagnosed with chronic respiratory or cardiovascular diseases and to determine features that help estimate the probability of having PAH. Patient data is heterogeneous and noisy; therefore, standard biostatistics, such as one step binary regression/classification, are rendered ineffective in handling such heterogeneities, resulting in inflated false-positive rates.
We propose a two-steps approach comprising parallel ML techniques and utilising data from three patient cohorts constructed from CPRD GOLD and Aurum, HES (OP, APC, DID, and A&E):
1. Confirmed PAH cohort â PAH diagnosis within 180 days post-RHC
2. Potential PAH cohort- Chronic respiratory disorders or cardiovascular conditions with similar symptomology as PAH conditions, but not yet confirmed as PAH via RHC
3. Confirmed non-PAH cohortâ RHC and no PAH diagnosis within 180 days post-RHC.The approach uses a semi-supervised learning technique to refine a subgroup of patients within the potential PAH cohort who exhibit closest features with the confirmed PAH cohort. Independently, a binary classifier is trained to distinguish between confirmed PAH and non-PAH cohorts. Finally, the two parallel approaches are merged to further refine potential PAH subgroup. All mathematically significant features will be identified and further evaluated.
Insights from the model will allow a deeper understanding of patient subgroups with higher rates of PAH un(mis)-diagnosis and areas of unmet need where additional PAH education and awareness is required. Ultimately, patients can get diagnosed with PAH earlier, improving their survival chances.
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Health Care Resource Utilization related to vascular ulcers in England — Samy Suissa ...
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Health Care Resource Utilization related to vascular ulcers in England
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-18
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Alexander Cohen - Collaborator - King's College London (KCL)
Carlos Martinez - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Serena Granziera - Collaborator - San Giovanni and Paolo Hospital
Stephan Rietbrock - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Stephen Black - Collaborator - Guy's & St Thomas' NHS Foundation TrustOutcomes:
Additional (incremental) costs related with first time vascular ulcers.
Description: Technical Summary
This analytical observational matched cohort study using CPRD Aurum data and linked HES-ONS data aims to estimate the incidence and prevalence as well as the underlying aetiology, diagnostic procedures, treatments, healthcare resource utilization (HCRU) and costs related with first time vascular ulcers.
The study population will include individuals aged 18 to <90 at risk for an incident vascular ulcer between April 2013 and the most current data available.
The study cohort will consist of patients with a first time vascular ulcer comprising venous ulcers (superficial or deep venous ulcers), arterial ulcers and mixed arterial and venous ulcers. A propensity score and calendar day matched group of patients in the study population without vascular ulcer will be identified and used as reference group for determination of incremental HCRU and costs related with a first time vascular ulcer.
Patient characteristics will be presented using number and proportions for categorical variables and mean, standard deviation for continuous variables. Crude incidence rates for vascular ulcers will be calculated from the number of patients with a first vascular ulcer divided by total sum of person time at risk in the study population. Prevalence rates of vascular ulcers will be calculated assuming exposure to a vascular ulcer from the initial ulcer diagnosis until the end of observational period. HCRU rate differences between the 2 matched patient groups will be calculated for each HCRU component and these differences will be multiplied with HCRU component-specific costs to estimate the additional costs of the vascular ulcer event. Analyses will be stratified by type of vascular ulcer, calendar year, age and gender.
The study outputs will allow clinicians and patients to have a stronger evidence base for the incidence, risk factors and types of vascular ulcers, to plan for prevention and more effective and less costly treatment.
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The association between urine protein:creatinine ratio, end-stage renal disease and healthcare resource use in patients with lupus nephritis — Jay Were ...
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The association between urine protein:creatinine ratio, end-stage renal disease and healthcare resource use in patients with lupus nephritis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-24
Organisations:
Jay Were - Chief Investigator - Health iQ
Muna Adan - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Boglarka Kovacs - Collaborator - Health iQ
Caoimhe Rice - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQ
Mico Hamlyn - Collaborator - Health iQOutcomes:
Demographics (mean and median age on inclusion, gender, deprivation quantiles, and ethnicity categories). Clinical characteristics (Charlson comorbidities, Charlson comorbid index score, prescriptions medication for Lupus nephritis; corticosteroid, other-steroids, calcineurin inhibitors, mycophenolate, other immunomodulators, cyclophosphamide, rituximab, smoking status and body-mass index). Mean and median follow up time. Healthcare resource outcomes (mean GP-consultations, total appointments and cost in primary care, outpatients appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatients HRG tariffs cost per patient per year) Clinical outcomes; diagnosis of end-stage renal disease post index-date and during follow up and survival time during follow up.
Description: Technical Summary
The development of ESRD in LN patients significantly increases morbidity, mortality and leads to enormous healthcare cost. We wish to conduct a retrospective cohort study to assess the use of urine protein: serum creatinine ratio (uPCR) in informing about ESRD occurrence in lupus nephritis. The primary objective is to evaluate the correlation between uPCR measurement and end-stage renal disease in patients with lupus nephritis. Secondary objectives are (a) to describe the demographics and clinical characteristics of patients with lupus nephritis, (b) to determine their healthcare resource use and cost. Adult patients with lupus nephritis will be identified in CPRD-HES linkage between 1st of April 2009 and 30th of June 2019. First urine protein:serum creatinine ratio (uPCR) following study start will be identified as index date (baseline measure) and ESRD-outcome will be identified during follow up. A two-stage analysis will be applied: first risk matrix association between the absolute value of uPCR at baseline and ESRD will be examined using multivariate logistic regression. uPCR will be included in the model as an ordered categorical variable and adjustments will be made for confounding variables. Secondly, the relationship between changes in uPCR and ESRD will be assessed using cox-proportional hazard regression with linear splines with knots at significant uPCR levels and adjusting for covariates. Annual average rates of healthcare resource use (as GP-consultations, out-patient appointments, A&E attendances, inpatient admissions, inpatient length of stay) and tariff admission cost will be estimated during follow up. Descriptive statistics will be used to capture sociodemographic and clinical characteristics of patients.
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Intimate partner violence, parental substance misuse and the mental health of parents & children - a retrospective open birth cohort — Ruth Gilbert ...
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Intimate partner violence, parental substance misuse and the mental health of parents & children - a retrospective open birth cohort
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-01
Organisations:
Ruth Gilbert - Chief Investigator - University College London ( UCL )
Dawid Gondek - Corresponding Applicant - University College London ( UCL )
gene feder - Collaborator - University of Bristol
Laura Howe - Collaborator - University of Bristol
Linda Wijlaars - Collaborator - University College London ( UCL )
Pia Hardelid - Collaborator - University College London ( UCL )
Rebecca Lacey - Collaborator - University College London ( UCL )
Stephen Morris - Collaborator - University of Cambridge
Outcomes: Incidence of mental health problems among children and young people; incidence of child maltreatment.
Description: Lay Summary
Almost one in four children and young adults in England have experienced domestic violence or abuse at home, which we refer to below as 'intimate partner violenceâ or IPV. IPV tends to co-occur with parental mental health problems, substance abuse, and mental conditions in children and adolescents. Given that half of mental health problems occur by adolescence, it is imperative to determine how IPV, parental substance abuse, and parental mental health affect children and young people's mental health. We have little understanding of how these relationships operate.
Technical Summary
The purpose of this project is to gain a better understanding of how IPV, substance abuse and parental and child mental health are related. For instance, whether families experiencing all three parental adversities, tend to be first identified in medical records as experiencing IPV, substance misuse or mental health problems. We will also compare the mental health of children exposed to parental IPV, substance abuse, and mental ill-health (and their combination) and those who were not exposed.
We will achieve this by creating a cohort of parents and their children followed over time, based on primary and secondary care records. By assessing variation in presentations related to IPV, substance misuse and mental health in parents and childrenâs routine health records, our research will guide GPsâ questioning about health within the family, checking the health of family members through the GP record household link, and follow up appointments. Our research will also guide the development of family-focused interventions that use existing general practice data.Intimate partner violence tends to co-occur with parental mental health problems and substance misuse having a strong relationship with child and young peopleâs mental health problems. However, there is a dearth of studies that explicitly examined the directionality of the relationship between these adverse parental experiences, and their association with children and young peopleâs mental health. The main objective of our study will be to better understand the longitudinal interrelationships between intimate parental violence, substance misuse and parental mental health in general practice and how these problems relate to child and young peopleâs mental health and child maltreatment. Findings will inform early detection and intervention for families at risk of these problems in primary care. We will aim to address this objective in the routine data records.
The clinical sample will include a birth cohort of mothers, fathers and children (born 1987 â 2021) from CPRD linked data using the CPRD mother-baby link. Children will be followed from birth to the latest available data point and linked to the Hospital Episode Statistics and Office for National Statistics for mortality data.
The interrelationship between intimate parental violence, parental substance misuse, parental mental health and child and young peopleâs mental health will be investigated by applying cross-lagged panel models. These are a type of structural equation modelling allowing for studying two or more variables measured repeatedly at one or more points in time. Cross-lagged models are typically used with longitudinal datasets to describe directional influences or reciprocal relationships between variables over time.
Findings will help us to better understand which of the parental adversities (parental intimate partner violence, parental substance misuse, parental mental health) tends to be recorded first in medical records, how strongly these events are inter-related over time, and how they influence children and young peopleâs mental health.
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Incretin-based drugs and the prevention of exacerbations of chronic obstructive pulmonary disease among patients with type 2 diabetes mellitus — Samy Suissa ...
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Incretin-based drugs and the prevention of exacerbations of chronic obstructive pulmonary disease among patients with type 2 diabetes mellitus
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-09
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sally Lu - Collaborator - McGill UniversityOutcomes:
The primary outcome will be the occurrence of the first episode of severe COPD exacerbation during the follow-up period. This will be defined as a hospitalization (identified using HES APC) with a COPD diagnosis in the primary position (definitions in Appendix 1).1, 2
There will be three secondary outcomes: (1) moderate COPD exacerbations (defined using a validated algorithm based on concomitant use of systemic corticosteroids and antibiotics)3, (2) count of moderate exacerbations, and (3) count of severe exacerbations (with events within 30 days of each other being counted as continuation of the same exacerbation episode for the count-based analyses).Description: Technical Summary
COPD and type 2 diabetes both highly prevalent diseases. While COPD increases the risk of diabetes, presence of diabetes results in frequent COPD exacerbations. Incretin-based drugs may reduce the frequency of exacerbations by reducing bronchial hyperresponsiveness. We will assemble a cohort of patients, at least 18 years of age, who initiated incretin-based drugs or sulfonylureas from 1 January 2007 (the year of availability of the comparator drugs in the United Kingdom) until 31 December 2019, with follow-up until March 31, 2020. Propensity scores will be computed to determine the predicted probability of treatment with GLP-1 RAs or DPP-4 inhibitors, separately, versus sulfonylureas. Cox proportional hazards models with propensity score fine stratification weighting will then be used to estimate hazard ratios of COPD exacerbation, separately for GLP-1 RAs and DPP-4 inhibitors. Secondary analyses will be conducted to determine whether there is a duration-response relation, association with individual drugs, and whether the association varies by age, sex, history of asthma, severity of dyspnoea at baseline, and predicted forced expiratory volume at one second. Given the relatively high mortality and morbidity associated with COPD among patients of type 2 diabetes, this study could have important implications for treatment guidelines, providing physicians, patients, and regulatory agencies with much-needed information.
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The management of gout in primary and secondary care in England and Wales: a descriptive study — James Galloway ...
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The management of gout in primary and secondary care in England and Wales: a descriptive study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-05
Organisations:
James Galloway - Chief Investigator - King's College London (KCL)
Mark Russell - Corresponding Applicant - King's College London (KCL)
Abdel Douiri - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes:
Co-primary outcomes: Initiation of urate-lowering therapy (ULT); attendance at emergency departments (ED) for gout flares; admission to hospital for gout flares.
Key secondary outcomes: Target serum urate level attainment; treat-to-target monitoring and uptitration of ULT.
Description: Technical Summary
Background: Gout is the most common form of inflammatory arthritis, with a rising incidence and prevalence worldwide. There are highly effective medications available to treat and prevent gout flares, yet previous research has shown that the management of gout in primary and secondary care is poor. One consequence of this is recurrent hospital admissions, which have doubled in England over the last 15 years. Many gout admissions are likely to be preventable with more widespread use of existing treatments.
Objectives: To describe the management of gout in primary and secondary care in England and Wales, including analyses of individual and structural predictors of hospitalisation and sub-optimal care.
Methods: The study population of interest is patients aged 18 years and above with index gout diagnoses between 2004 and 2021. We will describe the number and proportion of patients who are commenced on urate-lowering therapy (e.g. allopurinol) within 12 months of diagnosis. We will describe the pattern of serum urate monitoring and the proportion of patients who achieve target serum urate levels. We will use multi-level logistic regression to analyse individual and structural predictors associated with adherence to recommendations in national gout management guidelines. Through linkage with NHS Digital Hospital Episode Statistics Admission and A&E datasets, we will analyse predictors of hospitalisation and emergency department attendances for gout flares, and investigate post-discharge management, including time to first urate-lowering therapy prescription and/or re-admission, using Cox proportional hazards models.
Public health benefits: Our analyses will inform the development of a strategy to improve gout management in primary and secondary care in England and Wales; the impact for patients will be reduced morbidity, with fewer painful gout flares and reduced disability; the impact for NHS clinicians will include improved integration of care; and for commissioners, the impact will include reduced costs of unplanned admissions.
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Optimising therapies and disease trajectories for patients living with complex multimorbidity — Thomas Jackson ...
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Optimising therapies and disease trajectories for patients living with complex multimorbidity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-29
Organisations:
Thomas Jackson - Chief Investigator - University of Birmingham
Francesca Crowe - Corresponding Applicant - University of Birmingham
Aditya Acharya - Collaborator - University of Birmingham
Christopher Yau - Collaborator - University of Manchester
Eleanor Hathaway - Collaborator - University of Birmingham
Georgios Gkoutos - Collaborator - University of Birmingham
Jennifer Cooper - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Max Little - Collaborator - University of Birmingham
Peter Tino - Collaborator - University of Birmingham
Shamil Haroon - Collaborator - University of Birmingham
Steven Wambua - Collaborator - University of BirminghamOutcomes:
Primary outcomes
Diagnosis of another long-term health condition
Progression of a long-term health condition eg heart failure classified according to New York Heart classification stage I progressing to stage IVSecondary outcomes
All-cause mortality (ONS death date)
Cause-specific mortality
Acute hospitalisations
Number of medications prescribed
GP consultations with a clinician or nurseDescription: Technical Summary
People with multiple long-term health conditions are often prescribed multiple medications and have a high treatment burden which makes clinical decision-making complex.
At present research on people with multiple long-term health conditions has focussed on clusters of disease with a simple binary classification; not taking into account disease trajectories, the spectrum of disease severity, disease accumulation, or patientsâ and cliniciansâ attitudes. Understanding disease trajectories within clusters, taking into account subclinical disease and severity of disease, is important for early identification of populations at high risk of developing further diseases.
Treatment strategies in people with multiple long-term health conditions are based on single diseases leading to multiple medications being prescribed and complex decision making. Furthermore we do not know the effect of prescribed medications given for one component disease on trajectories of other component diseases. We need a deeper understanding of the interaction between diseases and prescribed medications.
We will develop a risk prediction algorithm to identify the likely next disease and the next best treatment option in patients with multiple long-term health conditions. We will identify disease clusters and trajectories using biomarkers and physiological measurements of disease severity, and then add in prescription data to model how they interact with trajectories of diseases. Prediction models will be based upon latent embeddings derived using deep neural network approaches to learn suitable representations from irregularly sampled, mixed data type, longitudinal sequence data that have recently been developed for observational electronic medical record data.
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Repurposing Drugs for Cancer Morbidity and Mortality based on Causal Evidence from Electronic Health Records — Ioanna Tzoulaki ...
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Repurposing Drugs for Cancer Morbidity and Mortality based on Causal Evidence from Electronic Health Records
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-26
Organisations:
Ioanna Tzoulaki - Chief Investigator - Imperial College London
Bowen Su - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Bang Zheng - Collaborator - Imperial College London
Shenbo Xu - Collaborator - Imperial College LondonOutcomes:
The events of interest are morbidity and mortality of breast cancer, prostate cancer, bowel cancer and lung cancer. Readcodes for each type of cancer can be found https://www.phpc.cam.ac.uk/pcu/research/research-groups/crmh/cprd_cam/câ¦
https://github.com/spiros/chronological-map-phenotypes/tree/master/primâ¦
https://github.com/rOpenHealth/ClinicalCodesThe event date of onset will be defined as the first cancer diagnosis date.
Description: Technical Summary
This study aims to examine whether already approved anti-diabetic drugs such as metformin and sulfonylureas can be used to lower the morbidity and mortality of breast cancer, prostate cancer, bowel cancer and lung cancer. We will conduct retrospective longitudinal cohort analyses with data on the effect of commonly prescribed first-line generic anti-diabetic drugs. As the real patient prescription behavior is not observed from EHR data, we will estimate the intention-to-treat effect of drugs on cancer based on Neyman-Rubin framework. For each pair of target drugs, we will adjust for confounding based on propensity score estimated by pre-treatment risk factors selected by physicians with material subject matter knowledge. We would like to adjust for age at initial prescription, initial prescription calendar year, gender, deprivation index, smoking status, body mass index, HbA1c, and comorbidities (e.g., cardiovascular diseases, depression, COPD, chronic kidney disease). Our goal is to balance probabilistic distribution between both intervention groups to ensure that one of our main assumptions called conditional ignorability holds. We can assume other critical causal assumptions including positivity and stable unit treatment value assumption (SUTVA) hold based on our study design. Apart from confounding bias, we will also investigate the impact of missing data. Missing baseline confounders and censoring will be considered based on missing mechanisms such as missing completely at random (MCAR), missing at random (MAR) and missing not at random (MNAR). The impact of confounding bias, missing baseline confounders and survivorship bias will be evaluated jointly by Markov factorization.
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Epidemiology of inflammatory bowel disease in the UK — Agustin Cerani ...
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Epidemiology of inflammatory bowel disease in the UK
Datasets:GP data, Incidence of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohnâs disease (CD) in the UK population by year, by age and by gender since 2005, using medical codes from CPRD GOLD and Aurum; prevalence of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohnâs disease (CD) in the UK population by age and by gender in 2020, using medical codes from CPRD GOLD and Aurum. Examination of patient characteristics, comorbid conditions, and history of medications.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-25
Organisations:
Agustin Cerani - Chief Investigator - Galapagos ( GLPG )
Agustin Cerani - Corresponding Applicant - Galapagos ( GLPG )
Ali Charkhi - Collaborator - Galapagos ( GLPG )
Andrew Maguire - Collaborator - EpiFocus Ltd
Claus Andersen - Collaborator - Galapagos ( GLPG )
Hari Patel - Collaborator - Galapagos ( GLPG )
Mona Khalid - Collaborator - Galapagos ( GLPG )
Raymond Schlienger - Collaborator - Galapagos ( GLPG )Outcomes:
Incidence of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohnâs disease (CD) in the UK population by year, by age and by gender since 2005, using medical codes from CPRD GOLD and Aurum; prevalence of inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohnâs disease (CD) in the UK population by age and by gender in 2020, using medical codes from CPRD GOLD and Aurum. Examination of patient characteristics, comorbid conditions, and history of medications.
Description: Technical Summary
Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the gastrointestinal (GI) tract that is non-infectious and progressive. IBD poses an increasing burden globally and in the UK, which has one of the highest prevalence of IBD in the world. Epidemiological measures of IBD vary substantially not only globally, but also in the UK, which could be attributed to inconsistencies in case definitions across studies. Further, the COVID pandemic has negatively impacted the diagnoses of many infectious and chronic diseases, including IBD, which directly impacts incidence and prevalence estimates. From a public health perspective, obtaining valid and updated epidemiologic measures are key for adequately determining resource allocation for IBD care, prevention and management in the UK.
Therefore, this study will estimate the incidence and prevalence of IBD. Yearly, and overall, estimates of incidence will be calculated since 2005, while the prevalence will be estimated at the cross-sectional date (31/12/2020). Results will be standardised to the UK population (or England and Wales for Aurum). Patient characteristics including comorbidities, comedication and demographics will be estimated at the date of diagnosis (incidence study) and at the cross-sectional date (prevalence study). This study will also provide the distribution of risk factors for cardiovascular events, venous thromboembolism and serious and opportunistic infections given that IBD may be associated with these harmful outcomes. The study will be performed in both CPRD GOLD and Aurum, and will include HES APC and patient-level Townsend linkages. This will be the first epidemiological study of IBD in Aurum and thus will benefit from the wider coverage of the EMIS network.
The evidence to be generated from the proposed study will support healthcare practitioners and public health authorities to prepare for the medical and socioeconomic challenges posed by IBD in the UK during the beginning of the new decade.
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Migraines and hypertensive disorders of pregnancy: a cohort study in in the UK Clinical Practice Research Datalink GOLD — Susan Jick ...
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Migraines and hypertensive disorders of pregnancy: a cohort study in in the UK Clinical Practice Research Datalink GOLD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-17
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Holly Crowe - Corresponding Applicant - Boston University School of Public HealthOutcomes:
The main outcome of interest in this study is hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia/eclampsia). Hypertensive disorders of pregnancy will be analysed as a binary composite outcome and categorically by severity (no hypertension, gestational hypertension, and pre-eclampsia/eclampsia). Read codes to select cases are provided in appendix 1.
Description: Technical Summary
Migraine is a neurovascular disorder common in the reproductive aged population, with an estimated prevalence of 17% in women ages 18-29 years and 24% in women ages 30-39 years.(1,2) Migraines can have profound impacts on daily activities and work, can affect quality of life, and are the seventh-highest specific cause of disability globally.(3,4) Hypertensive disorders of pregnancy (HDOP) include gestational hypertension and pre-eclampsia/eclampsia, and are associated with foetal death, preterm birth, maternal mortality, and neonatal intensive care admission.(5) Although there have been several studies on the association between migraines and hypertensive disorders of pregnancy, much of the existing literature is outdated, relies on inconsistent exposure definitions, and focused on pre-eclampsia rather than the spectrum of HDOP severity.(6,7)
The primary aim of this study is to evaluate the association between pre-pregnancy migraine and hypertensive disorders of pregnancy. We plan to conduct a cohort study for this analysis. First, we will select all deliveries from 1993-2020 with at least 24 months of data in the CPRD prior to the individualâs first delivery date. We will categorize deliveries to individuals with migraines prior to the estimated date of conception (delivery date â 280 days) as exposed. We will use log binomial regression with robust standard errors to estimate crude and adjusted risk ratios with 95% confidence intervals of HDOP among deliveries to individuals with pre-pregnancy migraines, compared to those without migraines, accounting for non-independence among individuals with more than one delivery. Additionally, the study will examine the association between migraines and HDOP for migraines treated with prescription medication vs. untreated migraines and migraines which resolve vs. persist beyond the first trimester of pregnancy.
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Rapid Safety Assessment of SARS-CoV-2 vaccines in 5 EU Member States using 10 electronic health care datasources — Olaf Klungel ...
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Rapid Safety Assessment of SARS-CoV-2 vaccines in 5 EU Member States using 10 electronic health care datasources
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-29
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Helga Gardarsdottir - Collaborator - Utrecht University
Romin Pajouheshnia - Collaborator - Utrecht University
Satu Johanna Siiskonen - Collaborator - Utrecht University
Svetlana Belitser - Collaborator - Utrecht UniversityOutcomes:
The list of AESI (as per EMA June 8 communication) is listed below, this list may be updated if new issues occur.
Multisystem inflammatory syndrome;
Acute respiratory distress syndrome;
Acute cardiovascular injury (microangiopathy, Coronary Artery Disease, Arrhythmia, Myocarditis, Pericarditis);
Coagulation disorders, including deep vein thrombosis, pulmonary embolus, cerebrovascular stroke, limb ischaemia, haemorrhagic disease (VTE (DVT & PE & Splanchnic), Cerebral venous sinus thrombosis, Arterial thrombosis, Thrombosis with Thrombocytopenia Sundrome (VTE, arterial thrombosis, or Cerebral venous sinus thrombosis with thrombocytopenia in 10 days), Hemorrhagic stroke, Disseminated intravascular coagulation);
Generalised convulsion;
Guillain Barré Syndrome;
Diabetes (type 1 and unspecified type);
Acute kidney injury;
Acute liver injury;
Anosmia/ageusia;
Chilblain-like lesions;
Single organ cutaneous vasculitis;
Erythema multiforme;
Anaphylaxis;
Death (any cause)** (postvaccination control window);
Sudden death (by codes)** (postvaccination control window);
Meningoencephalitis;
Acute disseminated encephalomyelitis (ADEM);
Narcolepsy;
Thrombocytopenia;
Transverse myelitis;
Bellsâ palsy;
Haemophagocytic lymphohistiocytosis ;
Kawasaki's disease ;
Pancreatitis ;
Rhabdomyolysis ;
SCARs ;
Sensorineural hearing loss;
Thyroiditis;Negative control events:
Gout;
Otitis externa;
Trigeminal neuralgia;Description: Technical Summary
The COVID-19 pandemic caused by SARS-CoV2 triggered the need for developing vaccines. This study will create readiness and allows for rapid assessment of the association of adverse events of special interest (AESI) following COVID-19 vaccination in 10 data sources in five countries, including UK CPRD.
Rapid assessment will be conducted using a retrospective observational study using electronic health care databases gone through the readiness phase. Eligible individuals will be included in the study from the start of vaccination campaignsand will end at the last date of data availability in each database. For specific events of concern, the study design will depend on whether the event is considered acute or non-acute and follow the decision framework described in the ACCESS template protocols (EUPAS 39361). The primary study design for acute events (events expected to occur within 60 days of vaccination) will be a self-controlled risk interval (SCRI) design and for non-acute events (events expected to occur or be diagnosed with delay, within 180 days) will be a cohort design with contemporary exposed comparators. Acute events may also be studied using the cohort design to address uncertainties around risk windows and limitations of the SCRI design. In the SCRI design, a non-exposed control window will be used.
Subjects start follow-up at time zero (time of vaccination or the start of the pre-vaccination control window for the SCRI) and end follow-up at the earliest of occurrence of latest data availability of the databank, subject exit, or the completion of the period, or death. At least one year of enrollment/ presence prior to time zero (cohort entry) will be required to determine whether individuals meet the study criteria and to define baseline characteristics.
Study results will be be followed-up by EMA, who will take regulatory action if needed to benefit public health for patients.
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Improving earlier diagnosis of coeliac disease of children and adults by predicting who is at higher risk of disease from their routine medical records — Colin Crooks ...
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Improving earlier diagnosis of coeliac disease of children and adults by predicting who is at higher risk of disease from their routine medical records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-17
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Laila Tata - Corresponding Applicant - University of Nottingham
Joe West - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of NottinghamOutcomes:
Coeliac disease
Description: Technical Summary
Background of need
Coeliac disease is common, affecting 1 in every 100 people in the UK, but fewer than a third of these are diagnosed. Early diagnosis allows dietary change to be recommended that avoids complications of growth and development in children and other detrimental health effects in adulthood, and reduces health care costs incurred by the NHS. Currently there is evidence of delay between peopleâs first presentation with symptoms and when they receive a diagnosis, with inequality in testing by socioeconomic deprivation.Project aim
To improve earlier diagnosis of coeliac disease in children and in adults of those at higher risk of the disease using all their routine medical records, thus enabling targeted testing.Proposed methods
1. Identifying risk factor patterns for coeliac disease: Using the information available for patients prior to Coeliac disease diagnosis or a pseudo index date in controls, we will use Bayesian supervised Latent Dirichlet Allocation topic modelling to learn predictive patterns of; symptoms, signs, consultation behaviour, diagnoses, tests and prescriptions; for both children and adults who are at risk of having coeliac disease, and compare these to their matched population controls.
2. Risk tool development: We will optimise an algorithm based on these risk factor patterns within the testing cohort to create a tool that flags people at risk of coeliac disease before their diagnosis whilst minimising false positives and false negatives. We will then perform internal validation and calibration on the final algorithm within a held-out validation cohort.
3. Comparison with traditional predictive model: We will compare the risk tool from 2. with more traditional predictive model methodology using logistic regression and selected candidate signs and symptoms based on current diagnostic guidelines, and assess the calibration and discrimination of this traditional predictive model compared to tool from 2. for identifying Coeliac disease early.
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The impact of painful musculoskeletal conditions on outcomes of community-acquired pneumonia — Kelvin Jordan ...
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The impact of painful musculoskeletal conditions on outcomes of community-acquired pneumonia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-11-18
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kayleigh Mason - Corresponding Applicant - Keele University
Alyson Huntley - Collaborator - University of Bristol
Christian Mallen - Collaborator - Keele University
Felix Achana - Collaborator - University of Oxford
James Bailey - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Martin Frisher - Collaborator - Keele University
May Ee Png - Collaborator - University of Oxford
Michelle Marshall - Collaborator - Keele University
Neil Heron - Collaborator - Keele University
Simon White - Collaborator - Keele University
stephen tatton - Collaborator - Keele UniversityOutcomes:
i) Hospitalisation for initial episode of pneumonia
ii) Length of stay in hospital for initial episode based on admission and discharge dates recorded in HES
iii) Readmission to hospital within 30 days of discharge for pneumonia
iv) Readmission to hospital within 30 days of discharge for any reason
v) (time to) Mortality based on recorded information in linked ONS data within 30 days of index date of diagnosis and up to 1 year after index date
vi) Cumulative health care use and costs over 1 year after index date. Primary care data will include number, type and length of consultations with each health care professional, prescriptions, tests and investigations. Secondary care utilisation includes referral, type of admission, length of stay, diagnosis, and procedures undertaken.Description: Technical Summary
In older adults with newly diagnosed conditions, comorbid musculoskeletal pain is common but often neglected. Musculoskeletal comorbidity could adversely impact outcomes if pain, and associated restricted functioning and sleep interference, prevent or delay delivery of appropriate treatment or reduce its effectiveness. It may increase the risk of hospitalisation for morbidities which may otherwise have been treated in primary care. As the final part of a series of four different clinical cohorts, we wish to investigate whether there is an impact of musculoskeletal comorbidity on outcomes in patients with community-acquired pneumonia. Using CPRD Aurum, HES admitted patient data and ONS mortality records, we will analyse data of patients newly diagnosed with community-acquired pneumonia and compare patients with a prior painful musculoskeletal condition requiring health care to patients without on the risk of hospitalisation, duration of hospitalisation, risk of readmission within 30 days after discharge, short term mortality, resource use and costs. Painful musculoskeletal conditions will be identified from primary care records in the 24-months prior to incident diagnosis of pneumonia. Robust Poisson regression will model impact of musculoskeletal pain on need for hospitalisation, readmission, and short-term mortality. Negative binomial regression will be used to determine differences in hospital length of stay. Flexible parametric survival models will be used for time to mortality after 30 days to 1 year. We will assess if impact varies by time of most recent musculoskeletal consultation or pain severity (proxy measures of musculoskeletal referral, analgesia prescription). We will also determine if inequalities exist in these relationships by socioeconomic characteristics (age, ethnicity, deprivation, geographical region), and if relationships differ by type of painful musculoskeletal condition. Our findings will allow assessment of the potential for existing evidence-based management of musculoskeletal pain and associated disability to be targeted at patients to improve outcomes following a diagnosis of pneumonia.
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Heart Failure Algorithm Validation and Calibration — Midlands and Lancashire CSU ...
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Heart Failure Algorithm Validation and Calibration
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Midlands and Lancashire CSU
Description: Heart Failure. Commercial
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Extension: Investigating integrated health care systems for children and young people (CYP) — Imperial College London...
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Extension: Investigating integrated health care systems for children and young people (CYP)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Health care systems for children and young people .
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Extension: Use of artificial intelligence applied to routine clinical and administrative healthcare data to identify people at risk of serious acute illness from COVID-19 infection. — Imperial College London...
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Extension: Use of artificial intelligence applied to routine clinical and administrative healthcare data to identify people at risk of serious acute illness from COVID-19 infection.
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Covid. Commercial
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Extension: Evaluation of the impact of the ‘total triage’ model using online consultations in general practice — Imperial College Healthcare NHS Trust...
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Extension: Evaluation of the impact of the ‘total triage’ model using online consultations in general practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Online consultations .
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Social deprivation group differences in health care use by children in North West London — Imperial College London...
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Social deprivation group differences in health care use by children in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Social deprivation in health care NWL (children).
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Extension: Supporting early feasibility for non-commercial studies in North West London — ICHNT...
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Extension: Supporting early feasibility for non-commercial studies in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: ICHNT
Description: Early feasibility for non-commercial studies .
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ID-170: Extension: Local-level analysis for the REAL Centre second annual report
— Midlands and Lancashire CSU ...
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ID-170: Extension: Local-level analysis for the REAL Centre second annual report
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Midlands and Lancashire CSU
Description: Analysis for the REAL Centre. Commercial
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A retrospective study: patient pathway and healthcare utilisation during the management of Obesity — Imperial College Health Partners...
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A retrospective study: patient pathway and healthcare utilisation during the management of Obesity
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Obesity . Commercial
Source
2021 - 10
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Demographics (Aggregate (small numbers not suppressed)) (Secondary uses) — NHS England & Improvement...
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NHS England and Improvement are planning for a potential COVID-19 antivirals trial. NHS E need to understand the proportion of current infections are in the CEV cohort so they can estimate potential trial candidates. Knowing what proportion of vulnerable patients make up the current infections will enable NHS England to understand stock levels for a national roll out. — IG-03430_5
Recipient Data Controller Organisation(s) : NHS England & Improvement
Approval Date: 18/10/2021
Purpose for which the data is being used: NHS England and Improvement are planning for a potential COVID-19 antivirals trial. NHS E need to understand the proportion of current infections are in the CEV cohort so they can estimate potential trial candidates. Knowing what proportion of vulnerable patients make up the current infections will enable NHS England to understand stock levels for a national roll out.
Dataset: Demographics
Category of Data: Aggregate (small numbers not suppressed)
Direct Care or Secondary Uses : Secondary uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR.
National Data Opt-out Applied: Not Applied - the data is not patient identifiable.
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The impact of the use of immunotherapy and risk of type I diabetes mellitus (TIDM) and other immune related adverse events: a population-based observational cohort study — Patrick Souverein ...
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The impact of the use of immunotherapy and risk of type I diabetes mellitus (TIDM) and other immune related adverse events: a population-based observational cohort study
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-26
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Ard van Veelen - Collaborator - Utrecht University
Frank de Vries - Collaborator - Utrecht University
Hans Petri - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Judith Gulikers - Collaborator - Utrecht University
Lizza Hendriks - Collaborator - Maastricht University Medical Centre
Olaf Klungel - Collaborator - Utrecht University
Robin van Geel - Collaborator - Maastricht University Medical Centre
Sander Croes - Collaborator - Maastricht University Medical CentreOutcomes:
For the primary analysis (objective 1), the incidence of TIDM will be the primary outcome of interest, thyroid specific adverse events (hypothyroidism and hyperthyroidism) will serve as secondary outcome. For the secondary analyses (objective 2), we will evaluate concordance in registration of patient- and disease-related characteristics in multiple databases.
Description: Technical Summary
In the last twenty years, the treatment-options for multiple cancer types, have increased considerably. A group of drugs that has become a serious treatment-option for several cancer types is immunotherapy. Those drugs block specific checkpoints within the immune system, thereby increasing the activity of the bodyâs own immune system against the tumour. Unfortunately, this form of therapy does not come without the drawback of adverse events, mainly immune-related adverse events (for example: TIDM, hypothyroidism and hyperthyroidism). TIDM is normally diagnosed early on in life. In the literature, multiple case-reports and case-series have been published that report the occurrence of TIDM after the start of immunotherapy. In this study we will evaluate the incidence of TIDM in patients that receive immunotherapy, compared to patients with the same condition that are not exposed to immunotherapy and were diagnosed between 01-07-2011 and 31-12-2018 with non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC). This will be the primary outcome. Hypothyroidism and hyperthyroidism will be used as secondary outcome. The number of patients with a specific adverse event and the incidence rate per 1000 person years will be determined and Cox proportional hazards models and cause specific proportional hazards models will be used to calculate hazard ratios (HRs) for patients treated with immunotherapy, compared to patients that have not (yet) been exposed to immunotherapy. Furthermore, this will be evaluated for every type of immunotherapy independently. Sensitivity analyses will be performed to evaluate the influence of adjusting specific assumptions in the primary analysis.
To put the results of the primary analysis into more perspective, we also will perform data quality checks and evaluate the similarities and differences in the collected data in multiple databases in the United Kingdom, such as CPRD GOLD, CPRD Aurum, hospital episode statistics (HES) and the cancer registry.
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Maternal Vaccination in the NHS (MAVIS) Study: Exploring the characteristics associated with (pertussis and influenza) vaccination in pregnant women — Emma Anderson ...
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Maternal Vaccination in the NHS (MAVIS) Study: Exploring the characteristics associated with (pertussis and influenza) vaccination in pregnant women
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-04
Organisations:
Emma Anderson - Chief Investigator - University of Bristol
Emma Anderson - Corresponding Applicant - University of Bristol
Christie Cabral - Collaborator - University of Bristol
Harriet Forbes - Collaborator - University of Bristol
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Peter Blair - Collaborator - University of BristolOutcomes:
Primary outcomes:
⢠Maternal pertussis vaccination (Y/N)
⢠Maternal influenza vaccination (Y/N)For secondary aim 4, below, we will treat vaccine location (primary care/ elsewhere) as an outcome.
Description: Technical Summary
Pertussis vaccination is recommended for pregnant women to give neonates passive immunity from birth when they are highly vulnerable to this prevalent infection. In 2016, a national roll-out began of National Health Service (NHS) maternity-service vaccination delivery (in addition to primary care) to increase access and uptake. Nevertheless coverage has remained around 70% since 2016 with Public Health England evidence indicating recent decline and continued vast regional discrepancies in coverage. Maternal influenza vaccination rates are also suboptimal, despite increased availability (including some maternity service provision).
This cohort study aims to describe the characteristics of women who did/did not receive their recommended maternal pertussis and seasonal influenza vaccines. Statistical analyses of national primary care data using the Clinical Practice Research Datalink (CPRD) GOLD database and linked records (mother-baby link, pregnancy register, Hospital Episode Statistics, index of multiple deprivation and rural-urban classification) will use logistic regression modelling to identify predictors of uptake (outcome=Y/N) of maternal vaccines since these have been introduced (2010 for influenza, 2012 for pertussis). Example predictors include; age, ethnicity, location and number of children. This study updates a prior CPRD study (reference:17_030) identifying social factors associated with maternal vaccination using records up to 2015. Re-analysis is needed to bring the findings up-to-date, and to assess the impact of increased maternity service vaccination. Vaccination location (primary care/maternity service/other) will be explored and analyses will compare predictors of pertussis vaccination before and after the major roll-out of maternity service provision of vaccines.
This is the first in a series of studies aiming to identify how NHS maternity services can be supported to improve vaccination coverage, aiming to reduce inequities. Identifying risk factors for being unvaccinated will inform targets for subsequent survey and interview research designed to explore and address womenâs needs and inform intervention/policy to address inequity in the vaccination programme.
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People living with diabetes and intermediate hyperglycaemia: risk of infections and effects of average level and variability of glycated haemoglobin (HbA1c) on this risk, in people from different ethnic groups — Tess Harris ...
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People living with diabetes and intermediate hyperglycaemia: risk of infections and effects of average level and variability of glycated haemoglobin (HbA1c) on this risk, in people from different ethnic groups
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-25
Organisations:
Tess Harris - Chief Investigator - St George's, University of London
Julia Critchley - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Elizabeth Limb - Collaborator - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Umar Chaudhry - Collaborator - St George's, University of London
Outcomes: A. Outcomes to be Measured
The primary outcome of interests are infections recorded in health care records. Specific infections will be chosen from those routinely treated in primary care and / or already shown to be associated with diabetes (see Appendix 1). Infections will be defined clinically based on Read codes plus an appropriate prescription (anti-bacterial, anti-fungal or anti-viral). We will link to HES and ONS Mortality data to assess risk of infection-related hospitalisation and mortality, respectively.
We will assess:
i) rates of specific infections (see Appendix 1 for details of infection outcomes);
ii) overall infection rates;
iii) infection related hospitalisation;
iv) risk of infection related mortality.Description: Lay Summary
Most people living with diabetes and their doctors worry about developing conditions like heart attacks, strokes, or eye and kidney damage. However, people with diabetes are more likely to get infections, with recent studies suggesting a much higher chance of getting more serious infections than previously thought. COVID-19 has recently focused attention on infection in people with diabetes and highlighted that people from ethnic minorities are more likely to get severely ill and die. Although there are many explanations, for some people this is linked to their diabetes, which is more common in some ethnic groups. We plan to examine the links between living with diabetes, high longer-term blood sugar levels (HbA1c), changes over time in HbA1c, and the risk of different infections, including but not limited to COVID-19. We will also estimate risks of infection among people with âpre-diabetesâ. We will select people who have been diagnosed with diabetes or pre-diabetes in the past using these health care records and then follow them through time to see if they develop infections. Because the datasets in the UK are very large and complete, we will be able to examine whether other factors (including age, sex, smoking status, obesity, ethnicity, HbA1c, or other health conditions) influence these risks.
Technical Summary
Our work could help develop future interventions specifically designed to reduce infections in people with diabetes. Better knowledge of infection risks and their links with diabetes and ethnicity could inform the response to future waves of COVID-19 and other pandemics e.g. influenza.A. Technical Summary (Max. 300 words)
Infections are common in people with diabetes and can substantially affect quality of life. Previous studies included mostly older people with type 2 diabetes (T2DM). We intend to estimate i) infection rates in specific patient groups (T2DM, T1DM and those with pre-diabetes or âintermediate hyperglycaemiaâ; IH), and how these risks vary by key characteristics; ii) how long-term glycaemic control and fluctuations in control (HbA1c) affect these risks.
We will obtain cohorts of people with diagnosed diabetes (T1DM, T2DM) or evidence of IH, age-sex and practice matched to people without DM or IH (control cohort). An alternative set of controls will be matched by ethnicity. We will include patients actively registered as of 1/1/2015 (1/1/2020 for COVID-19), followed to the end of 2019 (before the COVID-19 pandemic) and up to 2021 for COVID-19 infections. We will use Read codes to find people with diabetes, and also measurements of HbA1c or fasting blood glucose to select those with IH. Our main outcomes will be infections identified by Read codes accompanied by a relevant prescription in primary care. We will also investigate hospitalisation for infection, and infection-related mortality. We will estimate event rates for specific infections and infections overall during 2015-2019 (2020-2021 for COVID-19) using Poisson regression to adjust for confounders. Where possible we will assess effect modification (e.g. by age, sex, or ethnicity) by adding cross-product terms to models. To investigate associations with glycaemic control, we will estimate both average (mean) and variability (covariance) in HbA1c primarily focused on recordings made during the 4 years prior to study onset, including these estimates in multivariable models. We will stratify results by age, sex, and, where appropriate, ethnicity.
Our study will provide better estimates of infection risk and help identify people at greatest risk, enabling subsequent intervention development.
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Retrospective cohort study assessing medication coverage in prostate cancer patients prescribed Luteinizing Hormone Releasing Hormone agonists (LHRH). — Jay Were ...
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Retrospective cohort study assessing medication coverage in prostate cancer patients prescribed Luteinizing Hormone Releasing Hormone agonists (LHRH).
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-04
Organisations:
Jay Were - Chief Investigator - Health iQ
Muna Adan - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Boglarka Kovacs - Collaborator - Health iQ
Caoimhe Rice - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQOutcomes:
Number and percentage of missed prescription days (â¥3 day, â¥7 days, â¥14 days and â¥28 days delay) in a year. Proportion of days covered by drug formulation (in mean, median, min, max, s.d and IQR). Mean and median follow up time, PSA-levels and serum testosterone levels (in mean, median, min, max, sd and IQR). Survival time by drug formulation. Demographics (mean and median age on inclusion, age distribution, percent of males, deprivation, region, ethnicity) and clinical variables (Charlson comorbid index score, smoking status, BMI as categories).
Description: Technical Summary
The aim of this retrospective cohort study will include adult patients (aged â¥18 years) with a diagnosis of prostate cancer and a first prescription of luteinizing hormone-releasing hormone agonists (index date) between 1 January 2007 and 31 December 2019. We will require all patients to have at least 1-year of continuous registration in CPRD before the first recorded medications listed. To ensure that we have reliable measures of drug use and baseline covariates, we will require all patients to have at least 1-year of continuous registration in CPRD before the first recorded medications listed. All patients will be followed up from the index date until censure (death, practice transfer out date or study end). All patients will be followed up from the index date until censure (death, practice transfer out date or study end) and during follow up we will examine adherence, as well as missed or delayed injection treatment and overall survival by treatment adherence. We will determine adherence using proportion of prescription days covered and patients medication delay will be defined as an injection delayed of >= 3 days and >=7 days compared to pre-specified time window. Patients demographic and clinical traits will be described using descriptive statistics. Missed/delayed LHRH agonist injections per patients per year will be presented as mean (± standard deviation). Proportion of days (PDC) covered will be computed for each of the LHRH agonist injection and the association between patient variables and PDC will be analysed using non-parametric tests (Wilcoxon rank sum and Kruskal Wallis test). Lastly, joinpoint regression analysis will be used to model temporal changes in PSA-levels and testosterone levels during follow up and Kaplan-Meier curves will be produced to visualize the survival function.
I
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Investigating the applicability of regression discontinuity in electronic health record for assessing the effectiveness of prostate-specific antigen screening for the prevention of prostate cancer — Till Bärnighausen ...
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Investigating the applicability of regression discontinuity in electronic health record for assessing the effectiveness of prostate-specific antigen screening for the prevention of prostate cancer
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-28
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Maximilian Schuessler - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Min Xie - Collaborator - University Hospital Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
Primary outcomes will include mortality from CPRD. We are not planning to use ONS data as previous research has shown a strong overlap between CPRD and ONS mortality data.[30] We provide further detail on this below.
We aim to include secondary outcomes that can be measured in primary care, including referral to a specialists (CPRD), the diagnosis of prostate cancer (CPRD), inclusion into active surveillance programs (CPRD). We will also include subgroups of hospitalization relating to complications from prostatectomy using HES data.
Description: Technical Summary
Regression discontinuity (RD) design is a quasi-experimental method that takes advantage of decision rules that assigns patients to a clinical intervention if they fall above/below a cut-off point. RD can be used to assess the causal treatment effects in clinical medicine. This study seeks to determine the applicability and feasibility of RD in electronic health record (EHR) data in the field of clinical oncology. Specifically, we aim to (1) determine whether PSA thresholds are associated with a change in the probability of receiving a clinical intervention (here prostate biopsies and referral to urologists), (2) evaluate if patient characteristics are balanced within a small bandwidth surrounding these thresholds, and (3) investigate whether associations between the clinical intervention and patient outcomes are robust to different choices of bandwidth around the threshold. Exposure variables include tumour types, laboratory and physical measurements (e.g., body-mass index, age, lactate dehydrogenase, and haemoglobin). Patient outcomes include oncology-specific measurements and outcomes such as number/duration of hospitalisations, (tumour) pain, overall survival/mortality (overall and by cause of prostate cancer). We will estimate âfuzzyâ RD models using local linear regression to avoid overfitting data and triangular weights to give more influence to observations close to the threshold. In addition, we will use a mean squared error (MSE) optimal bandwidth that is empirically derived. We assess the sensitivity of the results using alternative bandwidths (e.g. bandwidths that are 50%, 75%, 125%, and 150% of the empirically derived mean squared error-optimal bandwidth). If feasible and applicable, RD analyses in EHR could generate valuable insights into the real-life effects of clinical intervention and help identify heterogenous treatment effects across more granular patient subpopulations, particularly in individuals that are normally excluded from clinical trials.
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Estimated prevalence of multiple long term conditions — Laura Potts ...
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Estimated prevalence of multiple long term conditions
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-14
Organisations:
Laura Potts - Chief Investigator - Public Health England
Laura Potts - Corresponding Applicant - Public Health England
Holly Townsend - Collaborator - Public Health England
Ian Wan - Collaborator - Public Health EnglandOutcomes:
Primary:
1) Estimation of the prevalence of multi-morbidity and physical and mental health comorbidity;
This involves the estimation of the prevalence of 2+, 3+ MLCs regardless of the type of condition captured by each cut-off
By
a) Sex, and area (region, Integrated Care Systems (ICS) and Local Authorities (LA))
b) Sex, age group (0-24, 25-44, 45-64, 65-84, 85+) and area (region, ICS and LA)
Please refer to section : Describe the study population in terms of key inclusions and see Expected prevalence can be calculated as follows paragraph for details on how sub regional estimates are calculated2) Estimation of prevalence by âprevalence typeâ ;
To provide further insight into the patterns in prevalence of multi-morbidity in (1) above, the prevalence of multiple LTCs will be estimated based on âprevalence typeâ i.e. physical conditions only, mental health conditions only, and physical/mental health conditions only.Estimated prevalence will be calculated by calculating the number of people with
1. Two or more physical (only) long term conditions;
2. Two or more mental health (only) long term conditions;
3. Two or more physical and mental health long term conditions (at least one in each category);
4. Three or more physical (only) long term conditions;
5. Three or more mental health (only) long term conditions;
6. Three or more physical and mental health long term conditions (at least one in each category);
By
c) Sex and area (region, Integrated Care Systems (ICS) and Local Authorities (LA)).
d) Sex, age group (0-24, 25-44, 45-64, 65-84, 85+) and area (region, ICS and LA).
Please refer to section : Describe the study population in terms of key inclusions and see Expected prevalence can be calculated as follows paragraph for details on how sub regional estimates are calculated.Secondary:
3) Prevalence of selected conditions and combinations of conditionsThis involves the estimation of prevalence of:
a) Selected conditions (hypertension, asthma, coronary heart disease, cancer, chronic obstructive pulmonary disease, stroke and mental health (other than dementia)) alone;
b) Selected conditions and the single condition they most commonly occur with;
c) Selected conditions plus additional conditions up to 4+ conditions i.e. selected conditions plus another condition, selected condition plus 2 other conditions, selected condition plus 3 conditions and selected condition plus 4 or more conditions;
d) Exploratory: Conduct an exploratory cluster analysis across all 38 conditions to identify common clusters ;
e) Exploratory: Perform multi-nominal analysis to see if the number of MLCâs can be predicted from socio-demographic and lifestyle factors;Description: Technical Summary
Whitty et al (1) identified MLCs are not just linked to older citizens; socio economic factors and life events come into play. In order to treat patients effectively predictable clusters of diseases can be identified, this will inform thinking into who to better tackle management of coexisting physical and mental health problems, which once identified can be embedded into medical training and continuous professional development, including for specialists.
Our objective is to firstly estimate the prevalence of MLCs (2+,3+ considering mental and physical health combined and separately) in England, at a regional level, and by local areas within it by sex and age group.
Secondly common MLCs patterns will be identified using summary statistics and cluster analysis considering MLCs and socio-demographic factors. The completeness of weight and smoking status will be assessed for consideration for inclusion.
The study population of interest will include all active registered patients in England from the CPRD Aurum dataset.
Public Health England (PHE) will identify MLC based on the Cambridge code list (2). This list identifies 38 long-term conditions from electronic health record data.
Long term conditions will be classed as present or not based on the Cambridge code list, the list considers time frames of conditions to allow for recovery of chronic conditions such as cancer.
Using the Index of multiple deprivation (IMD), sex, age and MLC at person level, MLC prevalence estimations will be calculated by matching and scaling based on ONS mid-year population estimates of IMD, sex and age.
Patterns of common MLCs will be identified between the 38 conditions from cluster analysis.
This research will help gauge the needs of people with MLC to improve delivery of care and help develop models of care for people with complex and MLC, in primary care including access to person-centred approaches.
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Influenza and pneumococcal vaccination in adults with common inflammatory conditions treated with immune suppressing drugs: a study of vaccine uptake, clinical effectiveness and vaccine safety. — Abhishek Abhishek ...
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Influenza and pneumococcal vaccination in adults with common inflammatory conditions treated with immune suppressing drugs: a study of vaccine uptake, clinical effectiveness and vaccine safety.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-11
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Abhishek Abhishek - Corresponding Applicant - University of Nottingham
Christian Mallen - Collaborator - Keele University
Georgina Nakafero - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of NottinghamOutcomes:
[1] Vaccine uptake study: Administration of inactivated influenza vaccine in the latest influenza cycle, and pneumococcal vaccine on any previous date.
[2] A. Clinical effectiveness of inactivated influenza vaccine.
Primary outcome: Primary-care diagnosis of influenza-like-illness.
Secondary outcomes:
a. Lower Respiratory Tract Infection (LRTI): Primary-care diagnosis of LRTI with antibiotic prescribed on the same date (6).
b. Chronic Obstructive Airway Disease (COPD) exacerbation: Either primary-care diagnosis of acute COPD exacerbation, or oral prednisolone and oral antibiotic prescriptions occurring on the same date in someone with a previous diagnosis of COPD (45).
c. Hospitalisation for pneumonia, and COPD exacerbation: Defined using International Statistical Classification of Diseases and Related Health Problems (ICD-10) in the inpatient Hospital Episode Statistics dataset.
d. Death including causes: Defined using ICD-10 codes in the Office for National Statistics dataset.[2]. B. Clinical effectiveness of pneumococcal vaccine
Primary outcome: Hospitalisation for pneumococcal pneumonia.
Secondary outcomes:
a. Hospitalisation for community acquired pneumonia.
b. Hospitalisation for COPD exacerbation as defined above.
c. Primary-care consultation for LRTI as defined above.
d. Primary-care consultation for COPD exacerbation as defined above.
e. Death due to pneumonia.[3] A. Influenza vaccination and disease flare.
Outcome: Flare of inflammatory bowel disease defined as either a new primary care prescription of corticosteroids after a 4-month gap (51) or hospitalisation for inflammatory bowel disease.
[3] B. Pneumococcal vaccination and disease flare up.
Outcomes: (a) Flare of inflammatory bowel disease defined as either new primary care prescription of corticosteroids after a 4-month gap (51) or hospitalisation for inflammatory bowel disease flare.
(b) Flare of autoimmune rheumatic disease: (a) primary care consultation for joint pain, (b) primary care corticosteroid prescription on the same date as joint pain consultation, (c) primary care consultation for RA flare.
Description: Technical Summary
Objectives: To examine
⢠uptake of influenza and pneumococcal vaccines in immunosuppressed adults with inflammatory conditions,
⢠association between vaccination with influenza and pneumococcal vaccines and respiratory infections, death due to pneumonia, and inflammatory disease flare-up in adults with inflammatory conditions. The safety and clinical-effectiveness of influenza vaccine in autoimmune rheumatic diseases has been demonstrated by us recently and will not be revisited.Methods:
Data source: Clinical Practice Research Datalink (CPRD)-Gold. Incepted in 1987, it is a longitudinal anonymised electronic database containing health records of 14 million UK residents. It contains details of diagnoses, prescriptions, immunisations, and is linked with hospitalisation and mortality records. Linked Hospital Episode Statistics and Office for National Statistics databases will be used to define hospitalisations and mortality.Population: Adults with inflammatory bowel disease (IBD) or autoimmune rheumatic disease prescribed immune-suppressing medicines.
Outcomes:
[1] Vaccine uptake: Administration of inactivated influenza vaccine (IIV) in latest influenza cycle, and administration of pneumococcal vaccine previously.
[2] Clinical effectiveness: Primary-care consultation for influenza-like-illness (for IIV only), Lower Respiratory Tract Infection (LRTI) requiring antibiotics, Chronic Obstructive Airway Disease (COPD) exacerbation. Hospitalisation for pneumonia, COPD exacerbation. Death due to pneumonia.
[3] Vaccine safety:
Flare of IBD defined as either primary-care corticosteroid prescription after 4-month gap or hospitalisation for IBD.
Primary-care consultation for (a) joint pain, (b) joint pain with corticosteroid prescription on the same date, and (c) Rheumatoid Arthritis flare.Data analysis: Separate analyses will be performed for influenza and pneumococcal vaccines. Vaccine uptake will be examined in a cross-sectional study and stratified by age, inflammatory disease, and comorbidities. Cox-regression will be used to examine the association between vaccination and primary-care consultation, hospitalisation, and death due to respiratory infections in a propensity score matched cohort study. Association between vaccination and flares of IBD or rheumatic diseases will be ascertained using self-controlled case-series.
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Aclidinium Bromide Post-Authorization Safety Study (PASS) to Evaluate the Risk of Cardiovascular Endpoints: Arrhythmias — Peter McMahon ...
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Aclidinium Bromide Post-Authorization Safety Study (PASS) to Evaluate the Risk of Cardiovascular Endpoints: Arrhythmias
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-07
Organisations:
Peter McMahon - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Nuria Saigi - Corresponding Applicant - RTI Health Solutions
Alejhandra Lei - Collaborator - Astra Zeneca Ltd - UK Headquarters
Christine Bui - Collaborator - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Collaborator - RTI Health Solutions
Elena Rivero-Ferrer - Collaborator - RTI Health Solutions
Jaume Aguado - Collaborator - RTI Health Solutions
Jennifer Bartsch - Collaborator - RTI Health Solutions
Raquel Garcia Esteban - Collaborator - RTI Health Solutions
Sami Daoud - Collaborator - Astra Zeneca Ltd - UK Headquarters
Susana Perez-Gutthann - Collaborator - RTI Health SolutionsOutcomes:
Cardiac arrhythmias: Cardiac arrhythmias will be identified through primary discharge codes for arrythmias in Hospital Episode Statistics (HES), with admission date as the date of the event. Death from cardiac arrythmia will be identified through the ICD-10 codes recorded as the main cause of death in Office for National Statistics (ONS) data. The event date will be the date of death. The list of ICD-10 codes for the identification of arrhythmias can be found in Appendix A.
Atrial fibrillation and severe ventricular arrhythmias: Hospitalisation, or deaths due to atrial fibrillation (ICD-10: I48) or for serious ventricular arrhythmia (SVA), i.e., torsade de pointes, ventricular tachycardia, and ventricular fibrillation or flutter (ICD-10: I47.0, I47.2, I49.0), will be identified as follows:
⢠Hospitalisations due to atrial fibrillation or SVA will be identified by a hospital primary discharge code for atrial fibrillation and SVA in HES, being the date of the event (index date) the admission date.
⢠Death from atrial fibrillation or SVA will be identified in ONS through ICD-10 codes for atrial fibrillation and SVA recorded as the main cause of death (i.e., in the cause variable), and the date of the event will be the date of death.Description: Technical Summary
This cohort study aims to evaluate the risk of arrhythmias in patients initiating aclidinium/formoterol and other fixed-dose combinations as compared to patients initiating LABA and in patients initiating other fixed-dose combination COPD treatments as compared to patients initiating aclidinium/formoterol. The study cohort consists in patients aged â¥40 years with COPD initiating aclidinium/formoterol or other fixed-dose combination COPD treatments in the CPRD Aurum in the UK between 2015 and 2021. All cases of arrhythmias will be included in the cohort study. Exposure to study medications will be ascertained through recorded prescriptions in the CPRD Aurum. The outcomes will include: 1) any type of cardiac arrhythmias, 2) atrial fibrillation and 3) serious ventricular arrhythmias. Arrhythmia event and date, and diagnosis for comorbidities of interest, will be defined based on information from the CPRD Aurum and from the inpatient Hospital Episode Statistic (HES) dataset and the Office for National Statistics (ONS). Statistical analysis will include: 1) descriptive statistics of the cohort; 2) cohort analysis to compare risk of arrhythmias associated with the use of aclidinium/formoterol and other fixed-dose combination COPD treatments versus LABA, and the risk associated with fixed-dose combination COPD treatments versus the risk associated with aclidinium/formoterol, including crude and adjusted incidence rates (IRs), incidence rate ratios (IRRs) and 95% CIs ; 3) IRs and IRRs of arrhythmias among patient subgroups of interest, e.g. by age categories; 4) effect of duration (short or long) of use.
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Residual excessive daytime sleepiness in obstructive sleep apnoea treated with continuous positive airway pressure in England: a retrospective cohort study using the clinical practice research datalink linked to hospital episodes statistics — ...
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Residual excessive daytime sleepiness in obstructive sleep apnoea treated with continuous positive airway pressure in England: a retrospective cohort study using the clinical practice research datalink linked to hospital episodes statistics
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-04
Organisations:
- Chief Investigator -
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Laura Tolan - Collaborator - OPEN Health Group
Mark Evans - Collaborator - OPEN Health Group
Mark McCormack - Collaborator - Harvey Walsh Ltd
Myriam Alexander - Collaborator - OPEN Health Group
Peadar O'Donohoe - Collaborator - Jazz PharmaceuticalsOutcomes:
rEDS; age, sex, geographic region ; smoking status; comorbidities (cardiovascular, psychiatric, gastrointestinal, obesity, sleeping disorders); comedications (antihypertensive, acid related gastric, non-steroidal anti-inflammatory, corticosteroids, psychiatric, central nervous system); ESS; and HCRU (primary care, secondary care inpatient, outpatient and accident and emergency, including sleep clinic attendances, sleep studies and road traffic accidents and full blood counts and thyroid function tests).
Description: Technical Summary
Obstructive sleep apnoea (OSA) is a common chronic condition characterized by repetitive episodes of upper airway collapse during sleep, affecting patientsâ quality of sleep. The standard treatment is with continuous positive airway pressure (CPAP), although some patients experience residual excessive daytime sleepiness (rEDS) on treatment. The aim of the study is to provide better understanding of OSA treated with CPAP, and of patients with and without rEDS.
The annual incidence and proportion of patients with any record of rEDS will be estimated in a study population of adults with CPAP-treated OSA identified from the Clinical Practice Research Datalink AURUM (CPRD). Subsets of the study population with and without rEDS after treatment will be described and compared for of the following: 1) characteristics including geographic region, baseline demographics, smoking status, Epworth Sleepiness Score (ESS) at baseline and follow-up, prior comorbidities and concurrent treatments (all from CPRD), 2) health care resource use (HCRU) in primary care (from CPRD) and secondary care (from Hospital Episode Statistics, [HES]), including sleep services (from HES and CPRD) post CPAP initiation.
Summary statistics will report frequencies and percentages for categorical variables and means, standard deviations, medians, interquartile ranges, and range for continuous variables. HCRU will be described as number of visits or inpatient spells per patient per year. Comparison between groups will use Chi-square tests for categorical variables, Studentâs t-tests for normally distributed continuous variables or Wilcoxon rank sum tests for non-normal distribution. If numbers allow, the study will test for an association between time from diagnosis to (i) sleep services and (ii) start of CPAP treatment with regard to the following outcomes: (iii) the risk of rEDS during follow-up (using Cox regression modelling, adjusting for patient characteristics); (iv) the frequency of sleep clinic attendances post-CPAP initiation (using an adjusted generalized linear regression model).
Source - and 18 more projects — click to show
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The effectiveness of faster aspart insulin versus other bolus insulins on glycaemic control in a real-world setting — Uffe Christian Braae ...
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The effectiveness of faster aspart insulin versus other bolus insulins on glycaemic control in a real-world setting
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-07
Organisations:
Uffe Christian Braae - Chief Investigator - Novo Nordisk
Uffe Christian Braae - Corresponding Applicant - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Anders Boeck Jensen - Collaborator - Novo Nordisk
Melanie Davies - Collaborator - University of Leicester
Pranav Kelkar - Collaborator - Novo Nordisk
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk
Usha Thamattoor - Collaborator - Novo NordiskOutcomes:
Glycaemic control; hypoglycaemia; treatment persistency
Description: Technical Summary
This study aims to compare the treatment effectiveness on glycaemic control of first time use of the ultra-rapid acting insulin Fiasp with rapid-acting bolus insulins in T1DM and T2DM patients living in England. Furthermore, we will investigate the change in the rate of hypoglycaemia after treatment initiation. Fiasp has proven efficacious at controlling glycaemic levels in T1DM and T2DM patients, however, limited real-world evidence is available describing the effectiveness of Fiasp compared to rapid-acting insulins. The study will use a retrospective cohort design, with the first time prescription date of Fiasp as index, to compare the effect on glycaemic control based on HbA1c concentrations prior to index and during a 12-month post-index follow-up period. Propensity score matching 1:1 will be used to allocate patients to treatment arms. Mixed model of repeated measures (MMRM) will be used to evaluate mean HbA1c levels from baseline to end of follow-up and change in HbA1c from index to 26 weeks post index. The frequency of hypoglycaemia will be evaluated by comparing the rate of hypoglycaemia prior to index with the rate of hypoglycaemia during follow-up for T1DM and T2DM, respectively, using a negative binomial regression model with a log-transformed follow-up time offset term. Treatment persistency will be evaluated by a Cox Proportional Hazard model estimating the hazard ratio for timeâtoâdiscontinuation of the first prescribed bolus insulin. This study will provide knowledge on the effectiveness of Fiasp treatment in T1DM and T2DM patients relative to a rapid-acting insulin treatment regimen in a real-world setting.
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Comparison of effectiveness and safety of direct oral anticoagulant versus low molecular weight heparin treatment for active cancer-associated venous thromboembolism — Marcela Rivera ...
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Comparison of effectiveness and safety of direct oral anticoagulant versus low molecular weight heparin treatment for active cancer-associated venous thromboembolism
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-07
Organisations:
Marcela Rivera - Chief Investigator - Bayer AG
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
George Psaroudakis - Collaborator - Bayer AG
Gunnar Brobert - Collaborator - Bayer AG
Khaled Abdelgawwad - Collaborator - Bayer AG
Samuel Fatoba - Collaborator - Bayer AG
Stephan Rietbrock - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)Outcomes:
VTE recurrences; significant bleeding events including major bleeds and clinically relevant non-major bleeds requiring hospitalisation; all-cause mortality.
Description: Technical Summary
This observational cohort study aims to investigate the effectiveness and safety of direct oral anticoagulant (DOAC) and low molecular weight heparin (LMWH) use in patients with active cancer-associated venous thromboembolism (CAT).
A cohort of patients with venous thromboembolisms (VTEs), defined as deep vein thrombosis or pulmonary embolism, after 01/01/2013, a cancer recording within 180 days before the VTE and recorded DOAC or LMWH use within 30 days after the CAT will be defined. Propensity scores for DOAC initiation in CAT will be estimated from multivariate logistic regression models in the complete study cohort. For each cohort member with DOAC treatment, up to 5 CAT patients with LMWH treatment will be matched based on propensity scores and the calendar day of cohort entry ±180 days.
Exposures of interest are DOAC compared with LMWH, and rivaroxaban compared with LMWH use. The outcomes of interest are VTE recurrences, significant bleeding (major bleeding and clinically-relevant non-major bleeding requiring hospitalization) and all-cause mortality at 3, 6 and 12 months following CAT.
Sub-distribution hazard ratios (SHRs) for VTE recurrence and significant bleeding will be estimated from multivariate Fine and Gray regression models accounting for the competing risk of mortality and adjusting for anticoagulant type (i.e. DOAC or LMWH), propensity score and potential confounders in the first 3, 6 and 12 months following the initial CAT respectively. For all-cause mortality hazard ratios (HRs) from Cox regression models will be used.
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Examining patterns and clusters of comorbidities in people with psoriasis — Darren Ashcroft ...
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Examining patterns and clusters of comorbidities in people with psoriasis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-14
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Alison Wright - Corresponding Applicant - University of Manchester
Christopher Griffiths - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Martin Rutter - Collaborator - University of Manchester
Richard Emsley - Collaborator - King's College London (KCL)Outcomes:
Morbidity prevalence - individual conditions, comorbidity and multimorbidity
(conditions selected based on clinical association with psoriasis, core conditions, diseases in the quality and outcomes framework and long-term conditions as defined by the NHS);
patterns of disease clusters; determinants of disease clustersDescription: Technical Summary
The proposed study will examine comorbidity patterns in people with psoriasis, estimating the prevalence of diseases, identifying clusters of similar conditions and subgroups of people with similar disease profiles.
Data will be obtained from CPRD GOLD and CPRD Aurum with linkage to hospital (Hospital Episodes Statistics), mortality (Office for National Statistics) and deprivation (Index of Multiple Deprivation) data. A common protocol will be applied across the databases for cohort construction and analysis. The study populations will comprise of adult patients with psoriasis, as identified from Read codes, between 1 January 1998 and 31 December 2020 who have been registered with a contributing practice for at least one year. The primary outcome will be comorbidities known to be associated with psoriasis. Crude and age-standardised prevalence rates will be calculated for each condition. Agglomerative hierarchical clustering will be used to identify comorbidity clusters. Latent class analysis will be used to identify distinct profiles of multiple disease among patients with psoriasis with multivariable regression analysis to predict latent class membership. Progression or changes in disease patterns will be examined by performing cluster and latent class analyses throughout follow-up.
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Bleeding events and adverse reactions in UK patients with non-valvular atrial fibrillation (NVAF) treated with edoxaban — FLORENT Guelfucci ...
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Bleeding events and adverse reactions in UK patients with non-valvular atrial fibrillation (NVAF) treated with edoxaban
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-26
Organisations:
FLORENT Guelfucci - Chief Investigator - Syneos Health Commercial France SARL
FLORENT Guelfucci - Corresponding Applicant - Syneos Health Commercial France SARL
Armel Ngami - Collaborator - Syneos Health Commercial France SARL
Eva-Maria Fronk - Collaborator - Daiichi-Sankyo Europe
Katharina Wenz-Poeschl - Collaborator - Daiichi-Sankyo Europe
Petra Laeis - Collaborator - Daiichi-Sankyo Europe
Ruediger Smolnik - Collaborator - Daiichi-Sankyo EuropeOutcomes:
Any bleeding; Major bleeding including gastrointestinal bleeding and Intracranial hemorrhage; Non-major bleeding; Adverse drug reactions (listed in the Summary of Product Characteristics); All-cause mortality; Cardiovascular-related mortality; Stroke (All type; Ischemic stroke; Hemorrhagic stroke; unknown type); Systemic embolic events (SEE); Transient ischemic attack (TIA); Myocardial infarction (MI); Hospitalizations related to cardiovascular (CV) condition (including AF related hospitalization); Major adverse cardiovascular events (MACE, composite endpoint of non-fatal MI, non-fatal stroke, non-fatal SEE and death due to CV cause or bleeding)
Description: Technical Summary
Daiichi-Sankyo is currently undertaking a non-interventional multicountry post-approval safety study (ETNA-AF study - EU-PAS register numbers EUPAS8896), in order to gain insight into the safety of edoxaban in non-preselected patients with non-valvular atrial fibrillation (NVAF) treated with edoxaban.
In this non-interventional retrospective study, we aim to evaluate the safety and efficacy of edoxaban in patients diagnosed with NVAF between 2015 and 2021 in the United Kingdom, using electronic medical record from the Clinical Practice Research Datalink (CPRD) Aurum with linkage to Hospital Episode Statistics (HES) databases. This study will be used to put in perspective the results of the ETNA-AF study pertaining to UK centers.
We will use Hospital Episode Statistics (HES) data to identify clinical events of interest, hospitalizations for all causes or related to specific conditions. Linkage to Office of National Statistic (ONS) will allow the determination of mortality rates (all-causes or Cardiovascular-specific).
The primary analysis will estimate the frequency of occurrence of safety events including major bleeding events, non-major bleeding events, drug-related adverse events and mortality in patients with NVAF treated with edoxaban during an overall observational period of up to 4 years.
The secondary analysis will assess the frequency of occurrence during the follow-up period of the following endpoint: stroke (ischaemic, haemorrhagic and unknown type), systemic embolic events (SEE), Transient ischemic attack (TIA), Myocardial infarction (MI), hospitalizations related to cardiovascular condition (including AF-related hospitalization) and MACE (major adverse cardiovascular events, composite endpoint of non-fatal MI, non-fatal stroke, non-fatal SEE and death due to CV cause or bleeding)
For each endpoint, a Kaplan-Meier plot will be displayed and the proportion of patients with at least one event of interest will be also provided.
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The safety of antipsychotic drugs in children and youth with attention deficit and hyperactivity disorder — Samy Suissa ...
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The safety of antipsychotic drugs in children and youth with attention deficit and hyperactivity disorder
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-07
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Claire Lefebvre - Collaborator - University Of Montreal
Mélanie Henderson - Collaborator - University Of Montreal
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Reem Masarwa - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
1. A composite endpoint of incident obesity and overweight
2. Incident dyslipidaemia
3. Incident type 2 diabetes
4. Incident obesity and overweight as individual endpoints
5. Primary arrhythmias
6. A composite endpoint of sudden cardiac death (SCD) and ventricular tachycardia (VT)
7. Prescription rates of approved ADHD drugs antipsychotic drugsDescription: Technical Summary
We will conduct a population-based cohort study including children and youth aged 5 to 24 years with an ADHD diagnosis between January 1st, 1998 and December 31st, 2020. Our primary objective is to compare the rates of a composite outcome of incident overweight/obesity in children and youth with ADHD exposed to antipsychotics to that among children and youth with ADHD prescribed approved ADHD drugs without antipsychotics. Our secondary objectives are to compare the risks of 1) incident type 2 diabetes; 2) incident dyslipidemia; 3) incident obesity and overweight as individual endpoints; 4) primary arrhythmias; 5) a composite endpoint of sudden cardiac death and ventricular tachyarrhythmia with use of antipsychotic drugs, compared to use of approved ADHD drugs only, among children and youth with ADHD; and 6) prescription rates approved ADHD drugs and antipsychotics among children and youth with ADHD.
To address these objectives, we will conduct a retrospective cohort study using a prevalent new user design. We will construct a base cohort of all children and youth aged 5 to 24 years with an ADHD diagnosis who received an indicated drug for ADHD (stimulants or non-stimulants) in the study period between January 1st, 1998 to December 31st, 2020. From this cohort, we will select our study cohort, which will include children and youth who received their first antipsychotic prescription (i.e., added to or switching from an approved ADHD drug) and matched comparators (those using approved ADHD drugs only). Individuals will be matched on age, sex, time since ADHD diagnosis, and time-conditional propensity score to minimize confounding. We will use Cox proportional hazards models to estimate hazard ratios and 95% confidence intervals for antipsychotics vs approved ADHD drugs for the outcomes of interest. Poisson regression will be used to calculate annual prescription rates of antipsychotics and approved ADHD drugs.
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Atherosclerosis following Deep Vein Thrombosis (ADVenT) study — Prakash Saha ...
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Atherosclerosis following Deep Vein Thrombosis (ADVenT) study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-10
Organisations:
Prakash Saha - Chief Investigator - King's College London (KCL)
Alex Dregan - Corresponding Applicant - King's College London (KCL)
Clemens Gutmann - Collaborator - King's College London (KCL)
Xiaohui Sun - Collaborator - King's College London (KCL)Outcomes:
The main outcome measure of the study is major cardiovascular events including myocardial infarction (MI), coronary heart disease (CHD), angina, stroke, transient ischaemic attack (TIA), and peripheral artery disease (PAD) identified using SNOMED-CT medical codes. Several secondary outcome will be investigated to include All-cause mortality; QRisk score; Blood pressure and/or total cholesterol treatment associated benefits/harms (e.g., hypotension, syncope, acute kidney injury).
Description: Technical Summary
Major cardiovascular events (e.g. myocardial infarction (MI), coronary heart disease (CHD), angina, stroke, transient ischemic attack (TIA), and peripheral artery disease (PAD)) occur more frequently in deep vein thrombosis (DVT) patients than in the general population, but the cause of this association remains unknown. Our pre-clinical experimental data suggests that this connection could be because DVT directly accelerates atherosclerotic plaque growth. The aim of this study is to investigate whether a similar relationship exists in patients. Patients who suffer MACE often have demonstrable evidence of increased cardiovascular risk prior to their MACE, including hypertension, hypercholesterolemia, obesity, and smoking. Long term management of these conditions commonly occurs in primary care. We now would like to investigate whether patients who suffer from a DVT go on to experience more MACE secondary to atherosclerosis. We propose to carry out a prospective matched control study, comparing the risk of future MACE among patients with a DVT event with a comparison group of those who never had a DVT. We will also consider several secondary outcome measures, including all-cause mortality, QRISK score, and benefits/harms associated with blood pressure and cholesterol-based therapy. The study participants will include patients aged 40 years and over at the time of first DVT diagnosis between January 2005 and December, 2020. Patients will be stratified by their baseline cardiovascular risk based on their age, sex and recognised risk factors including smoking history, hypertension, hypercholesterolemia and family history. Data will be analysed in a time to event framework (e.g. Cox regression), adjusting for baseline confounders using competing risk analysis. If there is an association between DVT and atherosclerosis, it would lead to a change in clinical practice to modify vascular risk factors in patients following DVT with the potential to save many lives.
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Post-Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine — Saad Shakir ...
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Post-Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-04
Organisations:
Saad Shakir - Chief Investigator - Drug Safety Research Unit
Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Hai Nguyen - Collaborator - Drug Safety Research Unit
Miranda Davies - Collaborator - Drug Safety Research Unit
Samantha Lane - Collaborator - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research UnitOutcomes:
Safety outcomes:
Outcomes will be defined homogeneously across the data sources to the fullest extent possible. Selected AESI currently planned for inclusion in the study are listed below and are based on those proposed by the ACCESS project (vACcine COVID-19 monitoring readinESS), which has been funded by the EMA to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once the vaccines are authorised in the EU (http://www.encepp.eu/encepp/viewResource.htm?id=37274.).
The Adverse Events of Special Interest (AESI) to be analysed in the study are:
Autoimmune diseases to include: Guillain-Barré syndrome; acute disseminated encephalomyelitis; narcolepsy; acute aseptic arthritis; diabetes mellitus type 1; (idiopathic) thrombocytopenia; thrombotic thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia (HIT)âlike event. Cardiovascular system outcomes to include: microangiopathy; heart failure; stress cardiomyopathy; coronary artery disease; arrhythmia; myocarditis; pericarditis. Circulatory system outcomes to include: coagulation disorders (thromboembolism; haemorrhage); single organ cutaneous vasculitis; thrombocytopenia, venous thromboembolism. Hepato-gastrointestinal and renal system outcomes to include: acute liver injury; acute kidney injury; acute pancreatitis; rhabdomyolysis. Nerves and central nervous system outcomes to include: generalised convulsion; meningoencephalitis; transverse myelitis; Bellâs palsy. Respiratory system outcomes to include: acute respiratory distress syndrome. Skin and mucous membrane bone and joints system outcomes to include: erythema multiforme; chilblain-like lesions. Other system outcomes to include: anosmia, ageusia; anaphylaxis; multisystem inflammatory syndrome; Death (any cause); subacute thyroiditis; sudden death. Maternal pregnancy outcomes to include: gestational diabetes; preeclampsia; maternal death. Neonatal pregnancy outcomes to include: foetal growth restriction; spontaneous abortions; stillbirth; preterm birth; major congenital anomalies; microcephaly; neonatal death; termination of pregnancy for foetal anomaly. Other outcomes to include: COVID-19 Disease; vaccine-associated enhanced disease (VAED).
First in period (possible recurrent) events will be assessed and case definition algorithms will be based on codes for diagnoses, procedures, and treatments. Definitions, codes, and proposed algorithms for all AESI will incorporate definitions developed by the ACCESS project (http://www.encepp.eu/encepp/viewResource.htm?id=37274)(https://drive.goâ¦).
Description: Technical Summary
The Pfizer-BioNTech COVID-19 vaccine, tozinameran (Comirnaty®) a novel mRNA-based vaccine, has been authorised in the European Union (EU), for prevention of COVID-19. Due to the shortened pre-authorisation development period and the limited clinical trials for COVID-19 vaccines, post-authorisation safety studies (PASS) are required to continue monitoring safety. This CPRD study, conducted in GOLD and Aurum databases, forms the UK component of this multi-database multi-country study conducted in Europe, fulfilling European Medicines Agency (EMA) requirements.
The study aims to determine whether there is an increased risk of selected adverse events of special interest (AESI) after vaccination with the Pfizer-BioNTech COVID-19 vaccine. A retrospective cohort design, comparing risk in vaccinated and non-vaccinated individuals and a self-controlled risk interval (SCRI) design will be used to determine whether an increased risk of prespecified AESI exists following the administration of at least one dose the Pfizer-BioNTech COVID 19 vaccine. The cohort study design will be used to estimate incidence rates of prespecified AESI among individuals who receive at least one dose of the Pfizer-BioNTech COVID-19 vaccine.
A cohort and/or SCRI design will be used to describe incidence rates and determine whether an increased risk of prespecified AESI exists following at least one dose of the Pfizer-BioNTech COVID 19 vaccine compared with a matched comparator group with no COVID 19 vaccination, within sub-cohorts of interest. The cohort study will determine whether an increased risk of prespecified AESI exists following at least one dose of the Pfizer-BioNTech COVID-19 vaccine compared with no COVID-19 vaccination, in pregnant people and their neonates.
In addition, the study will characterise utilisation patterns of Pfizer-BioNTech COVID-19 vaccine by estimating the proportion of individuals receiving vaccine; two-dose vaccine completion rate and distribution of time gaps between the first and second dose; demographics and clinical characteristics of recipients, overall and among sub-cohorts of interest.
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Trends in continuity of care in general practice: the impact of digital-first primary care on continuity of care before and during COVID-19 — Geraldine Clarke ...
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Trends in continuity of care in general practice: the impact of digital-first primary care on continuity of care before and during COVID-19
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-04
Organisations:
Geraldine Clarke - Chief Investigator - The Health Foundation
Elizabeth Crellin - Corresponding Applicant - The Health Foundation
Caroline Fraser - Collaborator - The Health Foundation
Emma Vestesson - Collaborator - The Health Foundation
Minal Bakhai - Collaborator - NHS England
Rebecca Fisher - Collaborator - The Health Foundation
Will Parry - Collaborator - The Health FoundationOutcomes:
Usual provider of care (UPC) index; Bice-Boxerman continuity of care index.
Description: Technical Summary
The aim of this project is to chart trends in continuity of care with a general practitioner over time between March 2018 and March 2021 and to assess how continuity of care was impacted by both new models of digital first primary care and the COVID-19 pandemic.
We will use data from electronic health records entered into CPRD for non-temporary patients registered at a nationally representative set of English general practices between 1 April 2016 and the latest available date. We will link CPRD data at the patient level to HES-APC data and IMD. We will also link CPRD data at the GP practice level to indicators of rurality (from the ONS) and participation in the COC programme.
Primary care contacts will be classified by consultation mode (remote or face-to-face) and staff type. Continuity of care will be measured using the usual provider of care (UPC) index, defined as the proportion of the patientâs contacts during the previous 12 months that that were with the most regularly seen doctor. We define the remote consultation index (RCI) as the proportion of a patientâs contacts during the previous 12 months that that were delivered remotely. We will calculate the UPC index and the RCI for each patient each month between March 2018 and the latest available date.
We will chart trends in average monthly UPC and RCI, stratified by age, sex, multimorbidity, socio-economic deprivation, higher and lower users of general practice care and practice participation in the THFCOC programme. We will use hierarchical logistic regression models to test the cross-sectional (between-person) association between UPC index and RCI in two cross-sectional studies using data from February 2020 and February 2021. We will then use fixed effects longitudinal regression models to identify whether within-person changes in RCI are associated with changes in UPC index.
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What biopsychosocial factors are associated with abortions in primary care in Britain? A case control study comparing women aged 13 to 54 who had abortions compared with those who did not. — Richard Ma ...
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What biopsychosocial factors are associated with abortions in primary care in Britain? A case control study comparing women aged 13 to 54 who had abortions compared with those who did not.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-25
Organisations:
Richard Ma - Chief Investigator - Imperial College London
Richard Ma - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Helen Ward - Collaborator - Imperial College London
Sonia Saxena - Collaborator - Imperial College LondonOutcomes:
Abortion is the outcome and âcaseâ definition. We will be examining associations between abortions and biopsychosocial factors (such as history of depression, domestic violence, parity, previous abortions, smoking, alcohol, past consultations for contraception) in women if different age groups.
Description: Technical Summary
Unintended pregnancies make up an estimated 44% of all pregnancies worldwide and 60% of these ends in abortions. Britain has among the highest teenage abortion rates in Europe. Together, these suggest significant room for improvement in contraceptive programmes in Britain and worldwide.
Unplanned pregnancies and abortion may be more complex than a matter of access to and use of effective contraception. Identifying these risk factors could be useful for the design of effective prevention programmes. There is very little research on the use of general practice records to identify those who might be at risk of unplanned pregnancies; studies have identified recent use of emergency contraception and previous pregnancies as risk factors for teenage pregnancies.
We will conduct an observational study using a database of general practice electronic health records (CPRD GOLD). Using a case control method, we will compare women aged 13 to 54 who had an abortion with women who did not, to better understand what the risk factors might be.
For each case, we will randomly select five women of the same age and from the same practice as controls. We will examine risk factors as reported in the literature including use of contraception, parity and previous abortions (linked using CPRD Pregnancy Register), index of multiple deprivation (IMD link), risk taking behaviour (alcohol, smoking and drug use), psychosocial factors (depression, anxiety, domestic violence).
We will use unadjusted and multiple conditional logistic regression for analysis and present odds ratios with 95% confidence intervals to compare postulated risk factors between cases and controls. We will also use interaction terms to examine associations between risk factors, starting with a priori from knowledge or theory.
The findings might help to design better prevention programmes that aim to address the biopsychosocial determinants of unplanned pregnancies and abortions in primary care.
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Falling through the cracks: patterns of care for people with markedly elevated blood pressure seen in English primary care — Primary outcome: ...
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Falling through the cracks: patterns of care for people with markedly elevated blood pressure seen in English primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-10-18
Organisations:
Primary outcome:
Number and percentage of patients who had at least 1 markedly elevated reading of systolic blood pressure [SBP] â¥160 mm Hg or diastolic blood pressure [DBP] â¥100 mm Hg who have a subsequent blood pressure reading recorded within 1, 3, 6 or 12 months (overall and in subgroups of age, sex, IMD quintile, geographic region and ethnicity). A sub-group analysis will be performed out with a subset of patients with a more extreme phenotype (SBP â¥180 mm Hg or DBP â¥120 mm Hg).
Secondary outcomes (overall and in subgroups of age, sex, IMD quintile, geographic region and ethnicity):
Number and percentage of patients who reach BP control target (recorded SBP <140 mm Hg and DBP <90 mm Hg) within 3,
6 or 12 months.
Median durations between the first measurement of elevated blood pressure and follow-up visit
Median duration between the first measurement of elevated blood pressure and control target achievement.
The number of markedly elevated SBP or DBP measurements during the study period (adjusted for length of follow-up)Outcomes:
Primary outcome:
Number and percentage of patients who had at least 1 markedly elevated reading of systolic blood pressure [SBP] â¥160 mm Hg or diastolic blood pressure [DBP] â¥100 mm Hg who have a subsequent blood pressure reading recorded within 1, 3, 6 or 12 months (overall and in subgroups of age, sex, IMD quintile, geographic region and ethnicity). A sub-group analysis will be performed out with a subset of patients with a more extreme phenotype (SBP â¥180 mm Hg or DBP â¥120 mm Hg).
Secondary outcomes (overall and in subgroups of age, sex, IMD quintile, geographic region and ethnicity):
Number and percentage of patients who reach BP control target (recorded SBP <140 mm Hg and DBP <90 mm Hg) within 3,
6 or 12 months.
Median durations between the first measurement of elevated blood pressure and follow-up visit
Median duration between the first measurement of elevated blood pressure and control target achievement.
The number of markedly elevated SBP or DBP measurements during the study period (adjusted for length of follow-up)Description: Technical Summary
This study is an extension of a recent US study that retrospectively analysed data on adult patients in the Yale-New Haven Health System.1 The aim is to adapt this study design for an English context and use CPRD Aurum to identify patients with markedly elevated blood pressure and characterise their follow-up care pattern. The authors of the original study are collaborators on this project.
Thisâ¯is an observational follow-up study of a random sample of adults aged under 80 with at least one markedly elevated blood pressure reading recorded during the study period (January 2015 to March 2020). Using an open cohort design, we will identify and follow-up two groups of patients: Group 1 - patients with at least 1 systolic blood pressure (SBP) â¥160 mm Hg or diastolic blood pressure (DBP) â¥100 mm Hg and Group 2 - patients with at least 1 systolic blood pressure (SBP) â¥180 mm Hg or diastolic blood pressure (DBP) â¥120 mm Hg (a subset of group 1 patients with a more extreme phenotype).
For each group, we will describe: 1) how often these patients have timely subsequent visits (within 1, 3 and 6 months), and 2) how commonly they ultimately achieve guideline-based blood pressure control targets (within 3, 6 or 12 months). We will also describe the median duration between the first measurement of elevated blood pressure and 1) a follow-up visit and 2) achievement of control target. A focus of the analysis will be to examine how these indicators vary by patientsâ socio-economic characteristics (age, sex, geographic region, ethnicity and deprivation) and clinical factors (BMI, smoking status, hypertension diagnosis, selected comorbidities).
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Extension: Care coordination for Adolescents in Crisis — Imperial College London...
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Extension: Care coordination for Adolescents in Crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Acute mental health for CYP in NWL .
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ID-164: Heart Failure Pathway Transformation: Health Economic Analysis — Imperial College Healthcare NHS Trust...
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ID-164: Heart Failure Pathway Transformation: Health Economic Analysis
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart Failure. Commercial
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Extension: Suicide Prevention Strategy Hammersmith & Fulham — London Borough of Hammersmith & Fulham...
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Extension: Suicide Prevention Strategy Hammersmith & Fulham
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith & Fulham
Description: Suicide prevention in London Borough of Hammersmith and Fulham .
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WLT Older People’s Mental Health Community Transformation — West London NHS Trust...
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WLT Older People’s Mental Health Community Transformation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Older people mental health .
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Extension: Impact of organisational models in general practice on patient safety and associated costs — Imperial College London...
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Extension: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: North West London.
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Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation — Imperial College London...
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Extension: Investigating multimorbidity among patients with depression and the relationship with secondary care utilisation
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Depression multimorbidity . Commercial
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Extension: Characterizing and Preventing Multimorbidity in NW London
— Imperial College London...
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Extension: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity in diabetes, pre-diabetes, hypertension, and depression .
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Extension: Psychological factors predicting clinical outcome following bariatric surgery — Imperial College Health Partners...
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Extension: Psychological factors predicting clinical outcome following bariatric surgery
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Bariatric surgery .
Source
2021 - 09
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Improving data sharing and access with synthetic data — unknown...
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Improving data sharing and access with synthetic data
Where: unstated
When: 2021-9-23
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project, led by the Behavioural Insights Team (BIT) and funded by ADR UK, is exploring whether and how synthetic data could aid cross-government data sharing for research.
What if society-level patterns in behaviour and outcomes could be easily analysed by researchers to inform policy and services, without risking the privacy of any individual citizen? An idea from a Harvard professor in 1991 [1] may provide exactly that: synthetic data.
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Covid-19 Population Risk Assessment.
(Identifiable) (Direct Care ) — GP Practices...
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To enable GPs to review their patients processed by the Covid-19 Population Risk Assessment who did not meet the threshold score to be added the SPL. The GP may use their clinical judgement and knowledge of the patient to add the patient to the SPL where necessary, the GP can use the Covid-19 Clinical Risk Assessment Tool as a decision support tool to help them with this. — IG-00554_10
Recipient Data Controller Organisation(s) : GP Practices
Approval Date: 03/09/2021
Purpose for which the data is being used: To enable GPs to review their patients processed by the Covid-19 Population Risk Assessment who did not meet the threshold score to be added the SPL. The GP may use their clinical judgement and knowledge of the patient to add the patient to the SPL where necessary, the GP can use the Covid-19 Clinical Risk Assessment Tool as a decision support tool to help them with this.
Dataset: Covid-19 Population Risk Assessment.
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice & Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice & Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â Direct Care.
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Demographics
(names, gender, DoB, death info, address, contact details, registered GP practice, restricted patient flag (Identifiable ) (Direct Care) — NHS England and the Department of Health and Social Care...
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The purpose of this is to enable Test and Trace to verify if a patient has been fully vaccinated and, where that is the case, exempt the patient from the need to self-isolate when they have been in contact with Covid-19. The dissemination of the PDS data is required to facilitate this process. — IG-03773
Recipient Data Controller Organisation(s) : NHS England and the Department of Health and Social Care
Approval Date: 09/09/2021
Purpose for which the data is being used: The purpose of this is to enable Test and Trace to verify if a patient has been fully vaccinated and, where that is the case, exempt the patient from the need to self-isolate when they have been in contact with Covid-19. The dissemination of the PDS data is required to facilitate this process.
Dataset: Demographics (names, gender, DoB, death info, address, contact details, registered GP practice, restricted patient flag
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - legal obligation
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) - public task
National Data Opt-out Applied: Not Applied - Direct Care and legal obligation overrides.
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Covid-19 3rd Primary Dose Cohort Data (Identifiable data where appropriate. Otherwise, aggregate data with no small number suppression.) (Direct Care) — NHS England...
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The purpose is to allow a GP practice to understand who they should invite for a 3rd primary dose of a COVID-19 vaccine. There are 2 key features planned for this data: 1)Â Â Â A 3rd primary dose report for urgent release: This report will allow a practice to see a list of their patients who are eligible for the 3rd primary dose. The feature will allow the practice to download the list for further processing (e.g. for loading into their GP system) 2)Â Â Â Uptake analysis â for later release: This feature allows a practice to see how uptake of the 3rd primary dose has progressed by age, ethnicity and sex for their patient community. This feature is all about quickly and clearly identifying those who were missed and enable them to be contacted. — IG-04443
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 30/09/2021
Purpose for which the data is being used: The purpose is to allow a GP practice to understand who they should invite for a 3rd primary dose of a COVID-19 vaccine. There are 2 key features planned for this data: 1)Â Â Â A 3rd primary dose report for urgent release: This report will allow a practice to see a list of their patients who are eligible for the 3rd primary dose. The feature will allow the practice to download the list for further processing (e.g. for loading into their GP system) 2)Â Â Â Uptake analysis â for later release: This feature allows a practice to see how uptake of the 3rd primary dose has progressed by age, ethnicity and sex for their patient community. This feature is all about quickly and clearly identifying those who were missed and enable them to be contacted.
Dataset: Covid-19 3rd Primary Dose Cohort Data
Category of Data: Identifiable data where appropriate. Otherwise, aggregate data with no small number suppression.
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) - substantial public interest plus DPA 2018 Part 2 Schedule 1 para 6 - Statutory and governmental purpose
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) - substantial public interest plus DPA 2018 Part 2 Schedule 1 para 6 - Statutory and governmental purpose
National Data Opt-out Applied: Not applied - legal obligation overrides
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Impact of prompt versus delayed initiation of single-inhaler triple therapy among patients with Chronic Obstructive Pulmonary Disease in England in real-world primary and secondary care settings — Kieran Rothnie ...
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Impact of prompt versus delayed initiation of single-inhaler triple therapy among patients with Chronic Obstructive Pulmonary Disease in England in real-world primary and secondary care settings
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-05
Organisations:
Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Robert Wood - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Lucinda Camidge - Collaborator - Adelphi Real World
Lucy Massey - Collaborator - Adelphi Real World
Olivia Massey - Collaborator - Adelphi Real World
Shannon Millard - Collaborator - Adelphi Real World
Victoria Banks - Collaborator - Adelphi Real WorldOutcomes:
Rate of subsequent AECOPDs (overall, moderate and severe); Time-to-first subsequent AECOPD (overall, moderate, and severe); Direct medical costs (all-cause and COPD-related); HCRU (all-cause and COPD-related); Hospital readmissions (all-cause and COPD-related); Time-to-first hospital readmission (all-cause and COPD-related)
Description: Technical Summary
Aim: To assess whether prompt versus delayed initiation of single inhaler triple therapy (SITT) fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) following a moderate-to-severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is associated with differences in subsequent AECOPDs, readmission and healthcare resource utilisation (HCRU)/costs among COPD patients in England.
Objectives: To evaluate i) rate of subsequent AECOPDs (overall, moderate, severe), ii) time-to-first subsequent AECOPD, iii) all-cause/COPD-related readmissions, iv) time-to-first readmission, and v) all-cause/COPD-related HCRU/direct medical costs, among prompt versus delayed initiators of SITT FF/UMEC/VI following an AECOPD. These objectives will be repeated utilising time-to-initiation of FF/UMEC/VI as a continuous variable; the rate of subsequent AECOPDs will also be assessed in patients with prior AECOPDs but no prior triple therapy.
Primary exposure: SITT FF/UMEC/VI initiation post-AECOPD
Outcomes: Rate of subsequent AECOPDs; Time-to-first subsequent AECOPD; Readmissions; Time-to-first readmission; HCRU; Direct medical costs
Methods: A new-user retrospective cohort study using inverse probability of treatment weighting (IPTW) of COPD patients initiating SITT FF/UMEC/VI within 180 days of an AECOPD, using linked CPRD Aurum and Hospital Episode Statistics data. The first/earliest moderate-to-severe AECOPD (Nov-2017âMar-2019) will determine the index date. 12+ months AECOPD-free pre-index data will be required. Patients will be categorised as prompt (0-30) or delayed (31-180) initiators dependent on timing of initiation post-AECOPD.
Data analysis: A propensity score (PS) method will be implemented to minimise potential confounding and evaluate average effects in the population. Logistic regression will generate the PS, which will be applied via IPTW. Rate of AECOPDs (events per person-year) will be compared using IPTW-weighted rate ratios (RRs) from negative binomial regression. Time-to-first AECOPD/readmission will be assessed using Kaplan-Meier estimates and compared using IPTW-weighted Cox proportional hazards regression. HCRU and costs (derived via application of unit costs/tariffs) will be compared using IPTW-weighted RRs from negative binomial regression and relative rates from generalised linear model, respectively.
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Defining disease patterns in adults with chronic pain and multimorbidity — Lauren Walker ...
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Defining disease patterns in adults with chronic pain and multimorbidity
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-30
Organisations:
Lauren Walker - Chief Investigator - University of Liverpool
Lauren Walker - Corresponding Applicant - University of Liverpool
Alexandar Vincent Paulraj - Collaborator - University of Liverpool
Christian Mallen - Collaborator - Keele University
Frans Coenen - Collaborator - University of Liverpool
Girvan Burnside - Collaborator - University of Liverpool
Kate Fleming - Collaborator - University of Liverpool
Munir Pirmohamed - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
Primary outcome will be time to accumulation of subsequent disease state(s) following acquiring an initial diagnosis of multimorbidity (second long-term condition) in people who acquire chronic pain at some point in their lifetime.
Secondary outcomes include a) understanding the patterns of analgesic prescribing associated with different disease acquisition and how this influences the multimorbid clusters; identify the determinants of multimorbidity (gender, socioeconomic status, smoking, alcohol, etc) in order to better understand the biological basis for disease clustering.
For analyses relating to multimorbidity incidence, the case cohort will be dynamic and cases will enter at the point at which they acquire a second long-term disease.
Description: Technical Summary
Background: The management of patients with multimorbidity and chronic pain is increasingly complex. Reliance on guidelines for the management of single diseases is a major contributor to increasing healthcare burden and polypharmacy. The use of multiple specialists to manage individual disease is costly and burdensome for both the health care service and patients alike, with oversight and support falling to the over-stretched GP. Understanding the scale of multimorbidity in people with chronic pain, and in particular the key determinants of different disease trajectories along with the factors associated with worse outcomes, is critical to the design of sustainable future services for those with complex care needs that will reduce pill burden, inform future drug development, and provide better models of care.
Aim: To better understand the prevalence and distribution of different patterns of diseases in people with chronic pain and multimorbidity in the UK and the effect on healthcare utilisation and prognosis. Understand the patterns of medicines prescription in relation to pain and multimorbidity, and the key determinants and age distribution of different disease clusters.
Design: Observational descriptive cohort study involving electronic health care records. A novel machine learning cluster algorithm, based on Frequent Pattern Mining, similar to âsupermarket basket analysisâ, will be used to cluster commonly co-occurring conditions. Comparison to exploratory hierarchical cluster analysis and Cox regression will be undertaken validate the accuracy of the machine approach.
Outcomes: Primary outcome will be time to accumulation of subsequent disease state(s) following acquiring an initial diagnosis of multimorbidity. Secondary outcomes include a) understanding the patterns of prescribing associated with different disease acquisition b) identify the determinants of multimorbidity (gender, socioeconomic status, smoking, alcohol, etc) in order to better understand the biological basis for disease clustering.
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Cardiovascular risk prediction in Rheumatic Diseases — David Hughes ...
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Cardiovascular risk prediction in Rheumatic Diseases
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Index
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-30
Organisations:
David Hughes - Chief Investigator - University of Liverpool
David Hughes - Corresponding Applicant - University of Liverpool
Jose Ignacio Cuitun Coronado - Collaborator - University of Liverpool
Kate Fleming - Collaborator - University of Liverpool
Sizheng Zhao - Collaborator - University of LiverpoolOutcomes:
A primary outcome of cardiovascular disease will be measured according to the specific definitions in each of the risk scores to be examined.
1. The QRisk3 CVD risk prediction tool defines cardiovascular disease as a composite outcome of coronary heart disease, ischaemic stroke, or transient ischaemic attack.
2. The Framingham Risk Score defines cardiovascular disease as a composite of CHD (coronary death, myocardial infarction, coronary insufficiency, and angina), cerebro-vascular events (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack), peripheral artery disease (intermittent claudication), and heart failure.
3. The Reynolds Risk Score defines cardiovascular disease as a composite of incident myocardial infarction, ischemic stroke, coronary re- vascularization, and cardiovascular deaths
4. The SCORE risk algorithm defines cardiovascular disease as a composite of ICD-9 codes 401 through 414 and 426 through 443, with the exception of the following ICD-9 codes for definitely non-atherosclerotic causes of death: 426.7, 429.0, 430.0, 432.1, 437.3, 437.4, and 437.5. We also classified 798.1 (instantaneous death) and 798.2 (death within 24 h of symptom onset) as cardiovascular deaths.Description: Technical Summary
This study aims to assess cardiovascular disease (CVD) risk in patients with psoriatic arthritis, psoriasis, ankylosing spondylitis, rheumatoid arthritis, and osteoarthritis. We will select all patients within CPRD Aurum who have these conditions (HES APC will identify any additional individuals with the specified rheumatic conditions). We will identify which of these patients experienced a CVD event following diagnosis of their rheumatic disease using both CPRD Aurum and HES APC. The definition of CVD outcome differs slightly for each risk tool, but broadly speaking includes coronary heart disease, cerebro-vascular events, peripheral artery disease and heart failure.
Our project aims to (i) describe the 10-year incidence rates of CVD for each condition using segmented linear regression to assess whether this incidence has changed over time and with improved treatment and (ii) assess the performance of four general population CVD risk tools (QRisk3, Framingham risk score, Reynoldâs risk score and SCORE) in patients with each condition. These risk tools underestimate CVD risk in patients with rheumatoid arthritis. We will determine whether this is also the case for other common rheumatic diseases.
Ten-year CVD risk will be calculated for each patient in our study using each of the four risk tools. The predicted risk will be compared to the observed risk. Discrimination will be assessed using area under receiver operating curve and calibration will be assessed.
CVDs are the leading cause of mortality in these patient groups. Improved understanding of their incidence (aim 1) will inform public health provision and prioritisation. It will also feed into patient-education material for lifestyle and self-management. Risk prediction and stratification (aim 2) will facilitate personalised prevention strategies, for example increased screening for CVDs and prevention using statins or lifestyle interventions in high-risk groups, optimising resource allocation for the health sector but also improve individual patient care and outcomes.
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Describing causes of mortality in different subpopulations of people with Chronic Obstructive Pulmonary Disease and determining factors that may be associated with specific causes of death — Jennifer Quint ...
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Describing causes of mortality in different subpopulations of people with Chronic Obstructive Pulmonary Disease and determining factors that may be associated with specific causes of death
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-15
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UKOutcomes:
Cause specific mortality
Description: Technical Summary
People with chronic obstructive pulmonary disease (COPD) are at increased risk of death compared to the general population. It is estimated that 1/3 of COPD patients with die of respiratory disease. We have undertaken work using CPRD data more recently and found that a large proportion die of COPD and that this has not really improved over time. One of the problems with COPD studies is that patients are usually investigated as a large group and yet we know that it is an umbrella term covering a spectrum of diseases. It is likely that certain phenotypes of COPD patients have different risk profiles for mortality. This study will investigate different causes of death amongst different phenotypes of COPD patients to see if there are potentially modifiable factors that could be addressed to ultimately reduce the mortality risk seen in this patient group and to help us better understand certain risk profiles that may predispose to certain causes of death.
The phenotypes we will consider are frequent and infrequent exacerbators, those who are immediately post exacerbation compared to stable, those who have chronic bronchitis compared to emphysema as well as by severity of airflow obstruction and by GOLD stage A-D. We will use CPRD Aurum linked to ONS data and HES APC data and IMD data will be used as a covariate in the analysis. The study period will be 2010-2020. Initially, in the overall cohort and then in each of the subgroups we will describe the cause of death and determine the commonest causes of death within each cohort using information derived by ONS.
We will then determine all-cause and cause-specific mortality within each phenotype. We will consider using logistic regression to determine what factors are associated with a certain cause of death.
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Prevalence of poorly controlled asthma and factors associated with specialist referral in those with poorly controlled asthma in a paediatric asthma population. — Jennifer Quint ...
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Prevalence of poorly controlled asthma and factors associated with specialist referral in those with poorly controlled asthma in a paediatric asthma population.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Louise Fleming - Collaborator - Imperial College LondonOutcomes:
Specialist referral defined as:
- Hospital respiratory clinics or paediatric clinics or allergy clinics
- CPRD asthma referral codesDescription: Technical Summary
Our objective is to better understand the burden of poorly controlled asthma, overall and among those with severe asthma (GINA steps 4 and 5) and to see if this has changed over time. In addition, we will investigate which factors may be associated with referral to specialists in those with poor asthma control. This will help to inform better referral pathways and management for asthma patients.
We will include a cohort of asthma patients aged 6â18 years and describe the proportion who have poor control, both overall and by disease severity (defined by asthma medications using the Global Initiative for Asthma (GINA) steps where steps 1â3 represent mild asthma and steps 4&5 severe asthma). We will investigate time to specialist referral in those with poor control and assess factors that may be associated with specialist referral. Poor control will be defined as at least one of: â¥2 courses of OCS / hospital admissions / A&E attendances in past 12 months, (i.e. asthma exacerbations), prescription of â¥6 SABA inhalers in past 12 months, FEV1/FVC <80%, or ACT/cACT <20.
We will use CPRD Aurum data linked with HES APC, HES A&E, HES OP and IMD data. The study period will be 2007â2019. We will calculate time to referral in the group of children with poor control. We will use Cox regression to compare time to referral in severe versus mild asthma patients. In the Cox model, we will adjust for sex, age, socioeconomic status, co-morbidities and possibly region. We will also undertake conditional logistic regression to determine factors associated with specialist referral using a nested caseâcontrol study design.
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The burden of rotator cuff tear in England: a retrospective cohort study of electronic primary healthcare records from the Clinical Practice Research Datalink and linked secondary care records from Hospital Episodes Statistics — ...
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The burden of rotator cuff tear in England: a retrospective cohort study of electronic primary healthcare records from the Clinical Practice Research Datalink and linked secondary care records from Hospital Episodes Statistics
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-30
Organisations:
- Chief Investigator -
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
David Heaton - Collaborator - Harvey Walsh Ltd
Leo Nherera - Collaborator - T.J.Smith and Nephew, Limited
Matthew O'Connell - Collaborator - Harvey Walsh Ltd
Myriam Alexander - Collaborator - OPEN Health Group
Neil Cameron Hatrick - Collaborator - Not from an Organisation
Paul Trueman - Collaborator - T.J.Smith and Nephew, Limited
Richard Searle - Collaborator - T.J.Smith and Nephew, Limited
Sue Beecroft - Collaborator - Harvey Walsh LtdOutcomes:
Age; sex; index of multiple deprivation; smoking; CCI; BMI; RCT-specific co-morbidities (osteoporosis, obesity, diabetes, hypertension, hypercholesterolemia); surgery for rotator-cuff repair, rotator-cuff retear, revision surgery for RCT; pain medications; corticosteroid injection; healthcare resource use (primary care visits for RCT; secondary care outpatient overall and at trauma and orthopaedics / physiotherapy departments; day case and elective inpatient admission for rotator-cuff repair; physiotherapy visits for RCT) and associated costs for each HCRU category.
Description: Technical Summary
Rotator cuff tears (RCTs) can result from injury or shoulder degeneration and cause loss of motion or pain in the shoulder. In the UK, RCT is initially managed in primary care using pain relief treatments and physiotherapy. When symptoms persist, patients may be referred to secondary care for assessment and possible surgery. There is a paucity of UK real-world information on the RCT patient population, treatment, referral pathway and associated healthcare resource use (HCRU). There is also uncertainty as to whether the waiting time from RCT diagnosis to surgery is associated with patient outcomes and HCRU.
The primary study aim is to estimate the incidence of RCT in England (2015-2019) and to describe the RCT population. Description will be using summary statistics in all RCT patients, and also separately in those who undergo / do not undergo RCT surgery. Demographics, smoking, index of multiple deprivation, body mass index (BMI), Charlson Comorbidity Index (CCI), and specific RCT-related co-morbidities as well as newly prescribed pain treatments post-RCT diagnosis (analgesics, corticosteroid injection as a longitudinal list) will be obtained from CPRD and / or HES. The volume of healthcare resource use (HCRU) 12-months prior and 12-months post-RCT diagnosis will be described and costed, including primary care visits (general practitioner [GP] / nurse / other allied healthcare professionals) on CPRD, and secondary care on HES (outpatient, overall, and specifically at trauma and orthopaedics / physiotherapy departments; day case and elective inpatient admission for rotator-cuff repair). A second aim is to further describe time to surgery, outcomes, and HCRU and costs in patients who undergo RCT surgery. The association between waiting time and post-surgery HCRU will be modelled using linear regression adjusting for potential confounders. Analyses will be completed overall and separately in < and >65 years old patients at RCT diagnosis.
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Mental health, substance abuse and risk of suicide in individuals with physical illness and neurodevelopmental disorders — Alvina Lai ...
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Mental health, substance abuse and risk of suicide in individuals with physical illness and neurodevelopmental disorders
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-26
Organisations:
Alvina Lai - Chief Investigator - University College London ( UCL )
Alvina Lai - Corresponding Applicant - University College London ( UCL )
Wai Chang - Collaborator - University College London ( UCL )Outcomes:
Suicide (fatal and non-fatal); self-harm; substance abuse; psychiatric disorders (anxiety; depression; schizophrenia; bipolar disorder; personality disorder); mortality all-cause; mortality cause specific.
Outcomes related to adherence and persistence with mental health medications:
(i) Adherence (estimated as the proportion of days covered [PDC]) where patients having PDC > 80% were considered adherent.
(ii) Persistence (individuals prescribed with drugs as persistent until a prescription gap >90 days, in which case they were non-persistent, or there was no further longitudinal data (in which case persistence status was unknown beyond that time).Description: Technical Summary
This study aims to evaluate the cumulative burden and risk of psychiatric disorders, self-harm and substance abuse in patients with physical illness and neurodevelopmental disorders. The mean cumulative count method that captures recurring events will be used to estimate the cumulative burden. Specifically, we will investigate the cumulative burden of psychiatric events (anxiety, depression, schizophrenia, bipolar disorder and personality disorder) in individuals with physical conditions and neurodevelopmental disorders. Propensity score matching will be used to assemble the control cohorts. In patients with comorbid physical and mental illness, we will investigate the risk of non-fatal self-harm and substance abuse using a matched cohort study design. In patients who self-harm, we will investigate the risk of suicide following self-harm and other natural and unnatural causes of death. We will investigate the prescribing patterns of drugs that treat mental illness, adherence to these drugs and how these drugs affect subsequent self-harm and substance abuse. CPRD GOLD and Aurum primary care datasets and the Hospital Episode Statistics dataset will be used for case ascertainment of psychiatric disorders, physical conditions, self-harm and substance abuse. Adjusted Cox proportional hazards regression analysis will be used to estimate hazard ratios for risk of self-harm, substance abuse and mortality. Anxiety and depression are highly prevalent in England and Wales and the incidence of both conditions has been increasing over the past year due to COVID-19. This study will also enable the evaluation of mental illness drug adherence and efficacy to help shape treatment guidelines to reduce the incidence of self-harm and substance abuse.
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Effects of the COVID-19 pandemic on primary care recorded anxiety and depression, and psychotropic prescribing. — Charlotte Archer ...
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Effects of the COVID-19 pandemic on primary care recorded anxiety and depression, and psychotropic prescribing.
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-19
Organisations:
Charlotte Archer - Chief Investigator - University of Bristol
Charlotte Archer - Corresponding Applicant - University of Bristol
David Kessler - Collaborator - University of Bristol
Nicola Wiles - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Bristol
Stephanie MacNeill - Collaborator - University of BristolOutcomes:
The outcomes are trends in recorded anxiety and depression, and trends in prescribing for anxiety and depression, in the UK between 1st March 2020 and 30th June 2021 (or the most recent available date).
Description: Technical Summary
This study will investigate the effect of the COVID-19 pandemic on trends in GP recorded anxiety and depression, and trends in prescribing for anxiety and depression, in the UK from 1st March 2010 to 30th June 2021 (or most recent available date), and examine associated factors. The study will use a retrospective cohort design, including patients aged 18 or over. The number of patients with a new episode defined by an anxiety or depression code in each calendar month will be calculated, and the number of patients who started psychotropic medication in each calendar month will be calculated.
Using data from the 10years before March 2020, we will use negative binomial regression models to estimate expected monthly incidence counts. For each month, observed and expected counts will be converted to rates using the observed person-month denominator. Monthly expected rates (95%CIs) will be plotted against observed rates. Differences between expected and observed rates will be expressed as relative rate reduction (percentages with 95%CIs). Trends (recorded codes/prescribing) over time will be examined for: (1) anxiety and depression combined; (2) anxiety; and (3) depression. For prescribing, for each of these three groups, data will be plotted to examine patterns of prescribing over time for all medications combined (antidepressants, anticonvulsants, benzodiazepines, antipsychotics, beta-blockers (antidepressants, antipsychotics and anticonvulsants only for group 3)), and separately for SSRIs. Data will be stratified by age, gender, region and deprivation. Joinpoint analysis will be used to explore key timepoints in the data.
The study will provide valuable insight into trends in GP recorded anxiety and depression, and prescribing for these conditions, during the COVID-19 pandemic. Findings will inform further research on the impact of the pandemic and remote consulting on patients with anxiety or depression, and will identify areas to explore in terms of future treatment for these conditions.
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Characterising surgery for wrist arthritis and its outcomes — Jennifer Lane ...
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Characterising surgery for wrist arthritis and its outcomes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-16
Organisations:
Jennifer Lane - Chief Investigator - University of Oxford
Jennifer Lane - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University HospitalsOutcomes:
Medical outcomes following surgery (within 30 or 90 days- where available in CPRD; full list given here for use in federated network analysis):
Acute kidney injury; Acute myocardial infarction events;Bleeding; Bradycardia or heart block; Cardiac arrhythmia;Cardiovascular-related mortality; Death; Renal/Dialysis; Heart failure; Hemorrhagic stroke (intracerebral bleeding); Ischemic stroke events;Mechanical ventilation;chest pain or angina; Pneumonia; Sepsis; Venous thromboembolic (pulmonary embolism and deep vein thrombosis) eventsSurgical outcomes (within 30, 90 days - where available in CPRD; full list given here for use in federated network analysis):
Wound infection requiring antibiotics; Wound infection requiring surgical management; Deep surgical site infection including septic arthritis; Neurovascular injury; Tendon injurySurgical outcomes (within 30, 90 days, 365 days and during all follow up - where available in CPRD; full list given here for use in federated network analysis): Fracture; Prominent metalwork requiring removal; Reoperation; Non-union
Outcome cohorts will be identified using OMOP CDM codes for diagnoses, based upon some codes that have been previously validated in datasets included in OHDSI, but also using the ATLAS diagnostics tool to investigate orphan codes.Cohort entry and exit is defined as per the time at risk window: entry is at the index date, exit at date of death or migration, date of outcome, loss to follow up or where possible, 1825 and 3650 days after the index date.
Description: Technical Summary
Objectives:
The primary objective of this study is to describe the baseline demographic and clinical characteristics of individuals presenting with wrist arthritis, in addition to the occurrence of surgical treatment for this condition and the serious adverse outcomes following surgery. This will be explored overall and if sufficiently sampling exists, to also examine treatments and outcomes by sex, age and surgical subtype.Design:
Cohort study Cohort study using non-identifiable CPRD data mapped to the OHDSI Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) to evaluate the characteristics of patients with wrist arthritis and the treatments used.
3 cohorts will be generated, namely:
1. All patients with wrist arthritis
2. Patients with wrist arthritis who have undergone surgical management
3. Subgroups based upon of type of surgery undertaken (proximal row carpectomy, arthrodesis, denervation, arthroplasty, arthroscopy)
3. Subgroups based upon aetiology of wrist arthritis (osteoarthritis secondary to trauma, rheumatoid arthritis, crystalline deposition, idiopathic)Participants
All adult patients with an incident diagnosis of wrist arthritis will be included.Variables and Measurements
Treatment will be determined from the first recorded procedure; outcomes defined as the first incident event for each individual outcome (based upon those generated in protocol, using the OHDSI CDM Atlas tool). This study focusses upon characterising the populations rather than proceeding to further risk factor association studies at this stage.Expected Results
Incidence of patients presenting with wrist arthritis; incidence of treatments undertaken for wrist arthritis; incidence of serious adverse outcomes following intervention for wrist arthritis.
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Predicting Psoriatic Arthritis (PREDIPSA) - Dynamic modelling of primary care health-records for earlier diagnosis of psoriatic arthritis: a population-based study — Theresa Smith ...
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Predicting Psoriatic Arthritis (PREDIPSA) - Dynamic modelling of primary care health-records for earlier diagnosis of psoriatic arthritis: a population-based study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-09
Organisations:
Theresa Smith - Chief Investigator - University of Bath
Alex Rudge - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Julia Snowball - Collaborator - University of Bath
Neil McHugh - Collaborator - University of Bath
Rachel Charlton - Collaborator - University of Bath
William Tillett - Collaborator - University of BathOutcomes:
PsA diagnosis; clinical symptoms, blood tests and prescriptions that could be predictors of PsA.
Description: Technical Summary
Psoriatic arthritis (PsA) is a systemic, inflammatory disease associated with the skin disease psoriasis. PsA can be difficult to diagnose in primary care due to its heterogeneous nature and similarity to other forms of arthritis. This studyâs objective is to build predictive models to assist with the earlier detection of PsA in primary care. The primary aim is to develop a novel temporal Bayesian network to model patterns of clinical symptoms, blood tests and prescriptions associated with an increased probability of developing PsA in a cohort of patients with incident psoriasis. The modelâs performance will be compared to two common approaches for similar tasks in the literature: a Cox proportional hazards model and a neural network. This will be a cohort study consisting of cases of incident psoriasis so that the disease trajectory can be followed prospectively over time in the data.
However, not all PsA cases in the CPRD will have an incident psoriasis diagnosis. This could be due to psoriasis diagnosis concurrently or after their PsA diagnosis, or before the patientâs data entered the CPRD. To include these scenarios in the study, a secondary aim will be to incorporate all incident cases of PsA in a case-control study. Cases (those with incident PsA) and controls (those with no PsA diagnosis) will be required to have at least 5 years of data collection before the matched PsA index date to capture the progressive nature of the prodromal phase of PsA. This methodology will be used to verify that the direction of associations found in the primary study extends to the wider PsA population. Findings from this study could highlight characteristics of the pre-clinical phase of PsA, and predictive models could aid screening procedures by selecting patients at an elevated risk for referral to secondary care rheumatologists.
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Understanding the contribution of influenza vaccines to antibiotic prescribing in the UK population: A longitudinal analysis — Neil French ...
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Understanding the contribution of influenza vaccines to antibiotic prescribing in the UK population: A longitudinal analysis
Datasets:GP data, Patient Level Index of Multiple Deprivation; Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-19
Organisations:
Neil French - Chief Investigator - University of Liverpool
David Singleton - Corresponding Applicant - University of Liverpool
Daniel Hungerford - Collaborator - University of Liverpool
Kate Fleming - Collaborator - University of Liverpool
Marc Yves Romain Henrion - Collaborator - Liverpool School of Tropical Medicine
Miren Iturriza-Gomara - Collaborator - Path
Nigel Cunliffe - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of Liverpool
Roberto Vivancos - Collaborator - Public Health England
Samantha Kilada - Collaborator - University of Liverpool
Valerie Decraene - Collaborator - Public Health EnglandOutcomes:
Total antibiotic prescription (AP) for all consultations; AP by WHO classification (i.e., highest priority critically important antibiotics) for all consultations; AP for consultations classified as being for investigation or management of acute respiratory infection; AP for consultations classified as being for investigation or management of acute urinary tract infection; AP for consultations classified as being for investigation or management of acute gastroenteritis; AP by WHO classification for consultations classified as being for investigation or management of acute respiratory, urinary tract infections or acute gastroenteritis.
Description: Technical Summary
Aim: To assess antibiotic prescription (AP) in adults over 60 years of age, at-risk groups under 65 years of age and children according to influenza vaccination status.
Objectives:
To assess whether AP varies in (i) adults over 60 years of age, (ii) at-risk groups under 65 years of age, and (iii) children 0-11 years of age, by presence of influenza vaccination, using:
1. A self-controlled case series (populations i, ii and iii)
2. A cohort analysis (i, ii and iii)
3. An interrupted time series and change-point approach (i and iii)
These will be compared to suggest most effective strategies for future vaccine effectiveness assessments.Population: Adults over 60 years of age, at-risk groups under 65 years of age, and children aged 0-11 years, between 1 January 2005 and 31 December 2019.
Study design: Self-controlled case series, cohort study, or interrupted time series/change-point analysis
Primary exposure: Influenza vaccination
Secondary exposures: Rotavirus or herpes zoster vaccination (for approach validation)
Primary outcome: AP, measured as total annual patient days prescribed, in total and by WHO prioritisation categories for all consultations.
Secondary outcomes: AP associated with acute respiratory infection consultations
Control conditions: AP associated with acute gastroenteritis and urinary tract infection consultations.
Confounders and adjusters: Pneumococcal vaccination, socioeconomic deprivation, ethnicity, geography, GP, comorbidities, care seeking propensity, age, co-morbidities, influenza disease prevalence, vaccination uptake and effectiveness by season, and residual vaccination immunity.
Analysis:
Data will be analysed separately across the three population groups. Primary analyses will comprise a self-controlled case series, comparing AP and influenza vaccination over time via parametric or semi-parametric conditional Poisson regression models and frailty models, balanced against an array of confounders and adjusters. For cohort analyses, multivariable generalised linear models with a Poisson distribution approach will be used; for interrupted time series counterfactual and change-point models will be utilised.
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Linked Clinical Practice Research Datalink (CPRD)-Hospital Episode Statistics (HES) study to identify the burden of respiratory syncytial virus (RSV) in hospitalised children under 2 years of age — Caroline O'Leary ...
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Linked Clinical Practice Research Datalink (CPRD)-Hospital Episode Statistics (HES) study to identify the burden of respiratory syncytial virus (RSV) in hospitalised children under 2 years of age
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-26
Organisations:
Caroline O'Leary - Chief Investigator - IQVIA Ltd
Maria João Fonseca - Corresponding Applicant - IQVIA Ltd
Fiona Ingleby - Collaborator - IQVIA Ltd
Jessica Lundbom - Collaborator - IQVIA Ltd
Lawrence Farrell - Collaborator - IQVIA Solutions UK Limited
Lorena Cirneanu - Collaborator - IQVIA Ltd
Rachel Reeves - Collaborator - IQVIA LtdOutcomes:
This study focuses on descriptive analyses of patient demographics and clinical characteristics, HCRU, patient pathways, and on model estimation of the total national RSV burden. As such, all of the characteristics described can be considered study outcomes, namely:
Age at first admission; birth month; birth in RSV season; sex; birth weight; birth length; BMI; index of multiple deprivation; region; ethnicity; comorbidities (Chronic Lung Disease; Congenital heart disease; Prematurity; Neurological disorders; Immunodeficiency); high-risk status; calendar week of admission of interest; concomitant medications; procedures; providers; intensive care unit (ICU) usage; number of GP consultations; cost of GP consultations; number of inpatient hospitalisations; number of outpatient visits; number of Accident & Emergency (A&E) visits; total cost of secondary care visits; total cost of primary and secondary care visits; hospital length of stay; mortality.Description: Technical Summary
This retrospective cohort study will include a birth cohort of all infants all infants born between 01/03/2015 and 28/02/2017 within the CPRD-HES linked dataset. Infants will be followed until the age of 24 months for the identification of a hospital admission of interest, which includes RSV-specific-coded admissions (cohort 1), bronchiolitis-coded admissions (cohort 2) and any respiratory tract infection (RTI)-coded admissions (cohort 3).
As primary objectives, key patient and clinical characteristics will be described and primary and secondary health care resource utilisation (HCRU) and associated costs will be estimated in the 3 case cohorts and compared with the respective comparator cohort (all included infants who did not have any hospital admission of interest according to the respective case cohort definition). HCRU will be assessed in the month prior to and in the 10-<24 months after the first hospital admission of interest. For infants with no admission of interest, an equivalent period will be estimated.
As secondary objectives, the patient pathway will be described, including chronological mapping of a) primary and secondary care elective and non-elective consultations, and b) treatment pathway, including procedures, in the 3 case cohorts.
To overcome the infrequent use of RSV-specific codes and to have a more comprehensive approach, additional exploratory objectives are defined. The first is to define a complementary RSV-predicted case cohort based on a published algorithm, and answer all primary and secondary objectives for this cohort. The second is to estimate the total national burden of RSV-associated General Practitioner (GP) consultations, and total national burden of RSV-associated hospitalisations in hospitalised cases only using multiple linear regression modelling, by in/before season birth for infants aged <24 months.
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Preventing Unscheduled Hospitalisations from Asthma: a retrospective cohort study using routine primary and secondary care data in the UK (The PUSH-Asthma Study) — Shamil Haroon ...
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Preventing Unscheduled Hospitalisations from Asthma: a retrospective cohort study using routine primary and secondary care data in the UK (The PUSH-Asthma Study)
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-05
Organisations:
Shamil Haroon - Chief Investigator - University of Birmingham
Nikita Simms-Williams - Corresponding Applicant - University of Birmingham
Adel Hasan Mansur - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Prasad Nagakumar - Collaborator - NHS England
Rasiah Thayakaran - Collaborator - University of BirminghamOutcomes:
(1) Number of hospital admissions for asthma
(2) Prescriptions of short courses of oral corticosteroids for asthma exacerbations
(3) Number of high dependency unit (HDU) admissions for asthma exacerbations
(4) Number of intensive care unit (ICU) admissions for asthma exacerbations
(5) A composite measure including HDU and ICU admissions for asthma exacerbations
(6) A composite measure including hospital admissions for asthma exacerbations and prescriptions of short courses of oral corticosteroids
(7) Delivery of clinical care management for asthma after discharge from hospital (including prescriptions of inhaled corticosteroids, smoking cessation counselling, provision of an asthma management plan, demonstration of inhaler technique, and provision of an asthma review)Description: Technical Summary
Study design:
A retrospective cohort study.Primary exposure:
A coded diagnosis of asthma.Primary outcome: Asthma-related hospital admissions.
Secondary outcomes: prescriptions of short courses of oral corticosteroids (OCS), asthma-related high dependency unit (HDU) admissions, asthma-related intensive care unit (ICU) admissions, composite outcome including HDU and ICU admissions, and a composite outcome including asthma-related hospital admissions and prescriptions of OCS.
Prescriptions of OCS are a proxy indicator of asthma exacerbations.
The composite outcomes will increase the power of the study and precision of the estimated effect size.Methods:
We will establish a cohort of asthma patients with linked Hospital Episode Statistics (HES) data in CPRD which will be used to determine hospital admissions for asthma exacerbations.The cohort will be stratified into the following age-groups: 5-11, 12-17, 18+ years. We will describe the demographic and clinical characteristics of patients such as age, sex, and comorbidities. We will determine the incidence of asthma-related hospital admissions and quantify the association between proposed risk factors and number of asthma-related hospital admissions using a Poisson regression model. We will phenotype patients with an asthma-related hospital admission using cluster analyses.
We will externally validate existing risk prediction models for asthma exacerbations as a separate analysis using the extracted CPRD data from this study: these models will be identified from the existing literature and recent systematic reviews. We will also externally validate a novel risk prediction model in CPRD Aurum, developed by the University of Edinburgh. Assessing the performance of existing models will allow for the identification of the most promising models to be prospectively evaluated in randomised controlled impact trials and provide evidence for potential use in primary care.
We will assess the primary care management of patients after discharge from hospital following an asthma exacerbation, such as medication changes, smoking cessation advice and self-management plans.
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Use of inhaled corticosteroids in a primary care chronic obstructive pulmonary disease population and risk of cardiovascular disease — Jennifer Quint ...
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Use of inhaled corticosteroids in a primary care chronic obstructive pulmonary disease population and risk of cardiovascular disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-30
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Constantinos Kallis - Collaborator - Imperial College LondonOutcomes:
The primary outcome of interest is time to first cardiovascular disease event. This will include any of the following events: myocardial infarction, heart failure, ischemic stroke, arrythmia, and coronary heart disease (excluding MI). This outcome has been used before when investigating lung function decline and time to first CVD [1]. Composite CVD will be the first cardiovascular event during follow-up. Specifically, cardiovascular disease events will include GP recorded events (using CPRD Aurum data), hospitalised events (using HES), and mortality events (ONS).
Secondary outcomes will investigate each component of the composite CVD outcome separately if the data allow. We will not report any results where there are less than 5 events in a cell.
Description: Technical Summary
Chronic Obstructive Pulmonary Disease (COPD) patients are treated with short/long-acting bronchodilator inhalers. If symptoms persist or patients experience exacerbations of COPD, they are prescribed inhaled corticosteroids (ICS). The risks and benefits of ICS in the treatment of COPD are debated as whilst ICS has been shown to improve lung function (forced expiratory volume in 1 second (FEV1)) and reduce the risk of exacerbations, they have also been associated with increased risk of pneumonia. The WISDOM trial found that patients withdrawing from ICS but remaining on long-acting bronchodilators, had a similar risk of exacerbations to those who remained on triple therapy. It is now recommended that patients should be withdrawn from ICS if they are not frequent exacerbators and if they have low blood eosinophils. Despite this, evidence suggests that ICS may be protective of developing cardiovascular disease (CVD). CVD is important to investigate as it is the most common comorbidity in people with COPD due to shared risk factors and increased inflammation associated with COPD. Most studies that have investigated the association between ICS and CVD have been randomised control trials with short follow-up periods and specific populations of COPD patients. With this in mind, we aim to investigate the association between ICS use (both prevalent and incident use) and time to CVD event in a CVD naive populations of COPD patients over a 10 year follow up and investigate the association between ICS withdrawal and time to CVD. This will use CPRD Aurum data linked with HES and ONS to investigate GP recorded events, hospitalisations, and deaths from CVD causes. We plan to use Cox regression to investigate the association between ICS and time to first CVD event in a COPD population who do not have a history of CVD.
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Comparative effectiveness of combination therapies on mortality in chronic obstructive pulmonary disease (COPD) — Samy Suissa ...
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Comparative effectiveness of combination therapies on mortality in chronic obstructive pulmonary disease (COPD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-05
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The primary outcome event is death of any cause. The secondary outcome is the occurrence of the first severe exacerbation defined by hospitalisation for COPD. The safety outcome is the occurrence of the first severe pneumonia defined by hospitalization for community-acquired pneumonia.
Description: Technical Summary
The primary objective of this study is to compare the effectiveness and safety of maintenance treatment of chronic obstructive pulmonary disease (COPD) with the combination of a long-acting muscarinic antagonist, a long-acting beta2-agonist and an inhaled corticosteroid (LAMA-LABA-ICS) compared with the combination of the two bronchodilators (LAMA-LABA). We will conduct a cohort study where first time users of a LAMA-LABA combination (without ICS) or LAMA-LABA-ICS combination will be identified. This cohort will be weighted by fine stratification weights computed using the probability of treatment to create pseudo-population in which the distribution of confounders is balanced. Subjects in the cohort will be followed for up to one year or until the occurrence of death from all-cause, severe COPD exacerbation leading to hospitalisation, and hospitalization for community-acquired pneumonia (serious pneumonia).The weighted Cox proportional hazard model will be used to perform an as-treated analysis that assesses the effect of current use of the LAMA-LABA-ICS combination versus the LAMA-LABA combination on the risk of death and of severe COPD exacerbation, as well as pneumonia. Analysis by blood eosinophil levels, prior exacerbations, history of asthma, as well as different ICS, will be performed to assess the comparative effectiveness in these important subgroups.
The secondary objective is to compare the effectiveness and safety of fluticasone-based triple therapy with budesonide-based triple therapy on these outcomes. This will be done in a similar way, after dividing the LAMA-LABA-ICS initiators according to fluticasone or budesonide.
Using Aurum and GOLD primary care data restricted to linkable HES-APC patients to identify severe exacerbation and hospitalized pneumonia, this study findings should help inform clinical practice guidelines on determining the real world evidence for this important treatment.
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Common vaccines and the risk of incident dementia — Samy Suissa ...
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Common vaccines and the risk of incident dementia
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-26
Organisations:
Samy Suissa - Chief Investigator - McGill University
Paul Brassard - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Zharmaine Ante - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
The primary outcome of interest is incident diagnosis of dementia, as identified by Read codes (listed in Appendix 1).
Description: Technical Summary
Given the ageing population and the lack of effective treatment, the prevalence of dementia is projected to rise tremendously in the upcoming years. Nevertheless, a growing evidence has pointed towards the potential benefits of routinely administered vaccines, such as the influenza and pneumococcal vaccine, in reducing the risk of incident dementia. However, previous studies have several methodological shortcomings, rendering study findings difficult to interpret. Thus, future large-scale population-based studies are warranted to confirm the effectiveness of common vaccines in reducing dementia incidence.
Our hypothesis is that exposure to common vaccines, including the vaccine for influenza, pneumonia, shingles, and tetanus, diphtheria and pertussis (TDP), is associated with a lower risk of dementia. To investigate this potential association, we will conduct a cohort study with a nested case-control analysis. We will assemble a cohort of individuals at least 50 years of age between 1 January 1988 and 31 December 2018 and whom will be followed until 31 March 2021. Within this cohort, each dementia case will be matched with up to 40 dementia-free controls on sex, age, cohort entry, and duration of follow-up. Conditional logistic regression will be used to compute odds ratios (OR) and 95% confidence intervals (CI) to estimate the risk of dementia in the vaccinated group, compared with the unvaccinated group. In secondary analyses, we will assess the risk of dementia, stratified based on 1) the individual vaccine, 2) time since first immunization and 3) history of past immunization, age, sex, and socioeconomic status. Finally, we will conduct several sensitivity and ancillary analyses to assess the robustness of our results. Ultimately, we hope the findings from this large population-based study will inform future research and help develop novel strategies to reduce the widespread burden of dementia.
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Dose distributions of the injectable glucagon-like peptide-1 receptor agonists dulaglutide and semaglutide in patients with type 2 diabetes in UK primary care — Jonathan Rachman ...
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Dose distributions of the injectable glucagon-like peptide-1 receptor agonists dulaglutide and semaglutide in patients with type 2 diabetes in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-02
Organisations:
Jonathan Rachman - Chief Investigator - Eli Lilly & Co - UK
Robert Wood - Corresponding Applicant - Adelphi Real World
Amisha Patel - Collaborator - Adelphi Real World
Caroline Casey - Collaborator - Adelphi Real World
Christina Diomatari - Collaborator - Adelphi Real World
Iskandar Idris - Collaborator - University of Nottingham
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Lill-Brith von Arx - Collaborator - Eli Lilly & Co - UKOutcomes:
The starting dose, and subsequent dose escalations / de-escalations of dulaglutide or s.c. semaglutide; the number of concomitant T2DM medications taken at index; HbA1c levels during follow-up; BMI during follow-up
Description: Technical Summary
Rationale: Therapeutic inertia, defined as âfailure to advance therapy or to de-intensify therapy when appropriate to do soâ is a well described phenomenon in T2DM. Failure to up-titrate therapies to optimal therapeutic doses in a timely manner is a component of therapeutic inertia, which has not been well studied in relation to GLP-1 RAs.
Aim: To determine the dose distributions of T2DM patients on dulaglutide or s.c. semaglutide to evaluate how well dosing in clinical practice follows recommendations and understand the proportion not on an optimal therapeutic dose.
Objectives: To describe the: i) dose distributions of dulaglutide and s.c. semaglutide at 3, 6, 9 and 12 months after first prescription, by patient and disease characteristics, ii) proportion of patients that escalate/de-escalate dosage of dulaglutide and s.c. semaglutide iii) proportion of patients achieving target HbA1c levels at each dose iv) dosages of the first prescriptions of dulaglutide and s.c. semaglutide v) BMI of patient at each dose .
Primary exposures: T2DM (diagnosis or prescription of 2+ classes of glucose lowering medication), and dulaglutide or s.c. semaglutide prescription within primary care.
Outcomes: dulaglutide/s.c. semaglutide dose distributions and alterations, target HbA1c achieved
Methods: A retrospective cohort study design using data from the CPRD GOLD primary care database to identify T2DM patients with a first prescription of dulaglutide or s.c. semaglutide in primary care (index date) between Jan-2019 and Jul-2019. Dose distribution will be described at 3, 6, 9 and 12 months following indexing, with follow-up extending up to March 2020. The proportions of patients achieving target HbA1c levels and in BMI categories will also be described at 3-6, 6-9 and 9-12 months following indexing.
Data analysis: Frequencies and percentages will be reported for categorical variables, while counts, means, medians, standard deviations (SDs), interquartile range, and minimum/maximum values will be reported for numeric variables.
Source -
Delivery of smoking cessation and alcohol interventions in primary care in the UK — Tessa Langley ...
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Delivery of smoking cessation and alcohol interventions in primary care in the UK
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-26
Organisations:
Tessa Langley - Chief Investigator - University of Nottingham
Tessa Langley - Corresponding Applicant - University of Nottingham
Gemma Taylor - Collaborator - University of Bath
Ilze Bogdanovica - Collaborator - University of Nottingham
Yue Huang - Collaborator - University of NottinghamOutcomes:
For the purposes of this proposal âdelivery of smoking cessation and alcohol interventionsâ is defined broadly to include advice giving (such as brief advice), referrals to alcohol/smoking cessation services outside of primary care and prescribing of smoking cessation medication. It also includes screening questionnaires such as AUDIT or FAST (for alcohol) or the Fagerström test for nicotine dependence (for smoking), because these are likely to be undertaken alongside advice in line with the questionnaire results. Recording of smoking or alcohol consumption status alone is not defined as an intervention but will be assessed as an indicator of how often these behaviours are mentioned in consultations.
Smoking cessation interventions delivered to adults ages 18+ in primary care: detailed tobacco use assessment (e.g. Fagerström test); advice given; prescriptions for smoking cessation medication; referrals to smoking cessation services.
Alcohol interventions delivered to adults aged 18+ in primary care: detailed alcohol assessment (e.g. Alcohol Use Disorders Identification Test - AUDIT); advice given; referral to alcohol services.
Description: Technical Summary
Aim
To assess the delivery of stop smoking and alcohol interventions in primary care in the UK.We will determine what proportion of patients have received support to stop smoking or reduce their alcohol consumption in primary care. We will assess changes over the time and differences by age, sex, region and socioeconomic status, by body mass index (BMI), in people with and without a history of major physical morbidity, and in people with and without a mental health condition. We will determine whether the proportion of patients receiving this type of support changed during the COVID-19 pandemic.
Why this research is needed
Although smoking rates have consistently declined in the UK in recent years, around 1 in 7 adults still smoke regularly. Overall alcohol consumption has fallen in the past two decades; however, around a quarter of adults regularly drink over the low-risk guidelines and the majority of dependent drinkers are not accessing treatment. The NHS Long Term Plan committed to an increase in NHS efforts in relation to prevention and inequalities. Health care professionals are well-placed to provide advice and support to help people stop smoking and reduce alcohol consumption; however, it is not known whether these opportunities are being maximised in primary care, and how approaches to tackling smoking and drinking in primary care have changed over time.Design and methodology
We will conduct a population-based study using electronic medical records from CPRD. We will study the anonymised primary care records of millions of patients to calculate the proportion of patients receiving advice to quit smoking or reduce their alcohol consumption, prescriptions for stop smoking medication and referrals to specialist services over time. The impact of the COVID-19 pandemic will be analysed using interrupted time series analysis.
Source -
Non-invasive tests as prognostic biomarkers of liver events, cardiovascular events and all-cause mortality in individuals with obesity and or type 2 diabetes living in the United Kingdom: a longitudinal cohort study — Tina Landsvig Berentzen ...
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Non-invasive tests as prognostic biomarkers of liver events, cardiovascular events and all-cause mortality in individuals with obesity and or type 2 diabetes living in the United Kingdom: a longitudinal cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-15
Organisations:
Tina Landsvig Berentzen - Chief Investigator - Novo Nordisk
Tina Landsvig Berentzen - Corresponding Applicant - Novo Nordisk
Anders Boeck Jensen - Collaborator - Novo Nordisk
Jens Tarp - Collaborator - Novo Nordisk
Kamal Kant Mangla - Collaborator - Novo Nordisk
Kamlesh Khunti - Collaborator - University of Leicester
Katrine Grau - Collaborator - Novo Nordisk
Louise Maymann Nitze - Collaborator - Novo Nordisk
Maximilian Jara - Collaborator - Novo Nordisk
Mette Skalshøi Kjær - Collaborator - Novo Nordisk
Quentin Anstee - Collaborator - Newcastle UniversityOutcomes:
The three primary outcomes of the study are listed below. Events in each endpoint are defined as ICD10 or OPCS4 codes from Hospital Episodes Statistics (HES) Outpatient data, HES Admitted Patient Care Data or Office for National Statistics (ONS) Death Registration Data.
Time to liver event - using the first report of any of the below events captured in HES or ONS:
⢠Liver mortality (ONS)
⢠Hospital contact for hepatocellular carcinoma (HES)
⢠Hospital contact for liver transplant (HES)
⢠Hospital contact for chronic liver failure (HES)
⢠Hospital contact for liver cirrhosis (HES)
⢠Hospital contact for decompensated liver events:
- Portal hypertension (HES)
- Ascites (HES)
- Transjugular intrahepatic portal shunt (HES)
- Hepatorenal syndrome (HES)
- Hepatic encephalopathy (HES)
- Gastro-oesophageal varices with/without bleeding (HES)Time to CV event - using the first report of any of the below events captured in HES or ONS:
⢠CV mortality (ONS)
⢠Stroke (HES)
⢠AMI (HES)
⢠Hospital contact for unstable angina (HES)
⢠Hospital contact for heart failure (HES)
⢠Coronary revascularisation (HES)Time to all-cause mortality â using a record in ONS Death Registration Data:
⢠Death record by any causePlease see Tables 4 to 6 in Appendix 1 for the specific ICD10 and OPCS4 codes requested from HES and ONS used to define the events in each of the three endpoints. The defined liver and CV events occurring prior to baseline (index date) will be excluded in the time to liver and time to CV event analysis, respectively.
Description: Technical Summary
Biopsy-confirmed fibrosis predicts severe clinical outcomes in non-alcoholic steatohepatitis (NASH). Biopsies are, however, not usable in routine clinical practice and NASH is often undiagnosed/untreated. Simple non-invasive scores derived from standard measures (liver enzymes, body weight, type 2 diabetes (T2D), age) are associated with liver fibrosis. If such scores are associated with clinical outcomes, they could be used in clinical practice and help to address the significant unmet medical for better management of NASH.
The aim is to explore:
1. The prognostic potential of 6 non-invasive scores* on time to first NASH-related clinical outcome event in a population with obesity and/or T2D.
2. The prognostic potential of changes in 6 non-invasive scores* on time to first NASH-related clinical outcome event in a population with obesity and/or T2D.Using a longitudinal cohort design, adults (â¥18years) with obesity and/or T2D, at least one non-invasive score measurement in the Clinical Practice Research Datalink (CPRD) after 01 January, 2001, no alcohol-related disorders and/or other chronic liver diseases in the Hospital Episodes Statistics (HES) and/or no prescriptions of drugs inducing liver disease in CPRD are included. NASH-related clinical outcomes are liver events, cardiovascular events and all-cause mortality.
Aims are analysed using Cox proportional hazards models with age as time scale:
1. Associations between non-invasive scores at baseline and time to first event (liver, cardiovascular or death)
2. Associations between 6, 12, 36-months changes in non-invasive scores and time to first event (liver, cardiovascular or death)Individuals are followed from date of inclusion until time of first event recorded in HES or Office for National Statistics Death Registration, migration from the databases, 10-years of follow-up or 01 January 2020, whichever comes first. Sensitivity analyses addressing obesity/T2D, alcohol, age, event type and reverse causality are made.
*Fibrosis-4 Index. AST-platelet ratio Index. Forns Index. BARD-score. NAFLD fibrosis-score. AST/ALT-ratio
Source -
The impact of painful musculoskeletal conditions on outcomes of dementia — Kelvin Jordan ...
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The impact of painful musculoskeletal conditions on outcomes of dementia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-05
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kayleigh Mason - Corresponding Applicant - Keele University
Alyson Huntley - Collaborator - University of Bristol
Christian Mallen - Collaborator - Keele University
Felix Achana - Collaborator - University of Oxford
James Bailey - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Martin Frisher - Collaborator - Keele University
May Ee Png - Collaborator - University of Oxford
Michelle Marshall - Collaborator - Keele University
Neil Heron - Collaborator - Keele University
Simon White - Collaborator - Keele University
stephen tatton - Collaborator - Keele UniversityOutcomes:
i) Time to first admission to hospital (any cause) following incident diagnosis of dementia
ii) Length of stay in hospital based on admission and discharge dates recorded in HES
iii) Readmission to hospital within 30 days of discharge for the same primary reason as initial hospitalisation
iv) Readmission to hospital within 30 days of discharge for any reason
v) (time to) Mortality based on recorded information in linked ONS data
vi) Progression of disease defined as number of new indicators of dementia progression recorded in primary care in the first 12 months after diagnosis as defined in our previous study, addition of additional anti-dementia drugs, and palliative care register entry
vii) Management of index condition based on prescriptions recorded in primary care in the three months following the incident diagnosis. This will include (a) referral to a memory clinic or equivalent, (b) drugs used to slow progression of dementia (such as donepezil, memantine), and (c) drugs used in the behavioural and psychological symptoms of dementia (including antipsychotic agents, benzodiazepines, carbamazepine).
viii) Cumulative health care use and costs over 5 years after index date. Primary care data will include number, type and length of consultations with each health care professional, prescriptions, tests and investigations. Secondary care utilisation includes referral, type of admission, length of stay, diagnosis, and procedures undertakenDescription: Technical Summary
In people with long-term conditions such as dementia, comorbid musculoskeletal pain is common but often neglected. Musculoskeletal comorbidity could adversely impact outcomes if pain, and associated restricted functioning and sleep interference, prevent or delay delivery of appropriate treatment or reduce its effectiveness. As part of a series of four different clinical cohorts, we wish to investigate whether there is an impact of musculoskeletal comorbidities on outcomes in patients with dementia. Using CPRD Aurum, HES and ONS mortality records, we will analyse data of patients newly diagnosed with dementia and compare patients with a prior painful musculoskeletal condition requiring health care to patients without on the risk of (and time to) hospitalisation, duration of hospitalisation, risk of readmission within or beyond 30 days after discharge, pharmacological interventions for dementia, time to disease progression (including established markers of progression, mortality, first entry onto a palliative care register), resource use and costs. Painful musculoskeletal conditions will be identified from primary care records in the 24-months prior to incident diagnosis of dementia. Negative binomial regression will be used to determine differences in hospital length of stay and number of new markers of progression in the 12 months after dementia diagnosis. Flexible parametric survival models will be used for time to event outcomes (e.g. first hospitalisation, mortality, palliative care). We will assess if impact varies by time of most recent musculoskeletal consultation or pain severity (proxy measures of musculoskeletal referral, analgesia prescription). We will also determine if inequalities exist in these relationships by socioeconomic characteristics (age, ethnicity, deprivation, geographical region), and if relationships differ by type of painful musculoskeletal condition. Our findings will allow assessment of the potential for existing evidence-based management of musculoskeletal pain and associated disability to be targeted at patients to improve outcomes following a diagnosis of dementia.
Source -
Statin Treatment Options during vaccination against inFLUenza (STOPFlu) : a observational study of the interaction between statins and influenza vaccination — Adam Streeter ...
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Statin Treatment Options during vaccination against inFLUenza (STOPFlu) : a observational study of the interaction between statins and influenza vaccination
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-19
Organisations:
Adam Streeter - Chief Investigator - University of Exeter
Adam Streeter - Corresponding Applicant - University of Exeter
- Collaborator -
Andrea Shelly - Collaborator - University of Exeter
Lauren rodgers - Collaborator - University of Exeter
Sarah Walker - Collaborator - University of Exeter
William Hamilton - Collaborator - University of Exeter
William Henley - Collaborator - University of ExeterOutcomes:
Composite outcome: hospital admissions for influenza; consultations in primary care for symptoms consistent with influenza-like illness
Negative control outcome: shinglesDescription: Technical Summary
Background
Influenza vaccination is routinely advised for many at-risk groups including adults agedâ¥65 years and, and younger patients with diabetes and cardiovascular disease. Many of these patients are also likely to be prescribed statins for control of cardiovascular risk. However, the mechanism by which statins protect against heart disease may inhibit the immune response to vaccination, potentially lowering its efficacy. This is further complicated by statins themselves potentially offering some protection against influenza. Robust evidence is needed to guide clinical practice and ensure vaccine response is maximised.
Objectives
To evaluate the potential modifying effect of statins on the effectiveness of the influenza vaccine and as a prophylaxis against influenza.
Methods
Annual cohorts of patients eligible for the influenza vaccine will be selected from 2010-20. Our primary analysis will test for an association between statin use and influenza outcomes, amongst patients receiving the influenza vaccine. Secondary analyses will estimate influenza vaccine effectiveness separately among statin users and nonusers, and the extent of any prophylactic effect of statins. A composite influenza outcome will be primary-care consultations for influenza-like illness and hospital admissions for influenza. Cox regression will be used to model the time to influenza with weighting by propensity scores to adjust for confounders observed in the data. We anticipate residual bias from unmeasured confounders so will apply a before-and-after quasi-experimental study design, the prior event rate ratio method, to adjust for this. We shall evaluate any remaining residual bias, applying the analysis protocol to a negative control outcome, such as shingles, for which we expect no association with influenza vaccination. Since polypharmacy is likely to be prevalent in frail and older populations, further sensitivity analysis will screen the five other most common medications to assess the extent to which any observed interaction effect may be attributable to other, concomitantly prescribed medications.
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The epidemiology of type 1 and type 2 diabetes in the United Kingdom and the healthcare care cost and resource use associated with managing these conditions — ...
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The epidemiology of type 1 and type 2 diabetes in the United Kingdom and the healthcare care cost and resource use associated with managing these conditions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-30
Organisations:
- Chief Investigator -
- Corresponding Applicant -
- Collaborator -
Cerys Jenkins - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Chris Shepherd - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Darren Summers - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Harry Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient characteristics; Comorbidities; Healthcare resource use; Healthcare costs; All-cause mortality; Incidence; Prevalence
Description: Technical Summary
The aim is to describe the epidemiology of type 1 and type 2 diabetes and estimate and cost healthcare use by people with these conditions. Acceptable patients will be selected from CPRD GOLD and Aurum if they have a record of one or more of the following: a product code indicative of a glucose-lowering therapy or a medical code indicative of diabetes. Patients will be classified as having type 1 and type 2 diabetes by applying a series of previously published decision rules based on diagnoses, prescriptions for glucose-lowering therapies, BMI and HbA1c. For sensitivity analyses, a subcohort will comprise English patients eligible for linkage to the HES admitted patient care (APC) and outpatient datasets and the Office for National Statistics (ONS) death registration data. The start of CPRD follow-up will be defined as the later of the patientâs registration date and, in CPRD GOLD, their practiceâs up-to-standard date; the end of CPRD data follow-up will be defined as the earliest of the patientâs transfer-out date, date of death (if applicable), and the last data-collection date for their practice. The presentation date will be defined as that of the patientâs first ever record with a code indicative of the diabetes. For incident patients, selected if their presentation date occurs at least 90 days after registration, detailed patient characteristics will be determined. Time to death will be presented using KaplanâMeier curves. Healthcare resource use and associated costs will be estimated before and after presentation and comprise primary care contacts, primary care prescriptions, outpatient attendances and hospital admissions. Incidence and point prevalence will be calculated on a yearly basis.
This study will provide valuable information on the healthcare burden associated with diabetes and help to inform healthcare decision-making.
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Healthcare resources utilisation and associated costs of adult Attention deficit hyperactivity disorder in England: A retrospective database study — Sarah Jenner ...
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Healthcare resources utilisation and associated costs of adult Attention deficit hyperactivity disorder in England: A retrospective database study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-09
Organisations:
Sarah Jenner - Chief Investigator - IQVIA Ltd
Emily Wilkes - Corresponding Applicant - IQVIA Ltd
Lorena Cirneanu - Collaborator - IQVIA Ltd
Margherita Bortolini - Collaborator - IQVIA Ltd
Marios Adamou - Collaborator - Not from an Organisation
Peter Egger - Collaborator - IQVIA Ltd
Sarah Jenner - Collaborator - IQVIA LtdOutcomes:
Total HCRU including costs in ADHD patients within 18-months prior to diagnosis and total HCRU including costs within 18-months following diagnosis.
Description: Technical Summary
This is a retrospective cohort study to describe total healthcare resource use (HCRU) including costs of adult attention deficit hyperactivity disorder (ADHD) patients prior to diagnosis and post diagnosis in England. The study comprises an observation period from 2014 to 2019 and includes all patients aged 18+ years at study start and with an ADHD diagnosis (index date) between 2016 and 2018 (index period), a minimum of 18-months of data available before and after index date and without a history of ADHD including indicated-medication use prior to index date.
Study objectives include the evaluation of HCRU and associated costs in the 18-month period prior to the index date and comparing to those in the 18-month period after the index date. Diagnostic pathways of ADHD and post-diagnosis treatment patterns will also be assessed. Using CPRD-HES linked data, the healthcare records encompass both primary and secondary care and HCRU includes general practitioner appointments, referrals to specialists including mental health professionals, outpatient visits, investigations, A&E visits and inpatient hospitalisations, as well as prescribed pharmacological and non-pharmacological treatments. Costs will be grouped into prescription costs, primary health care consultations, investigations, outpatient appointments and hospital admissions. Patientsâ characteristics at index date, such as age and gender, deprivation, comorbidities and region will also be evaluated.
The analysis comprises a description of HCRU and associated total costs in the pre and post index periods and a comparison using descriptive statistical measures for categorical and continuous variables as appropriate. Costs will also be compared using statistical tests.
In addition, the outcomes will be evaluated for the subgroups a) patients managed under the NICE CG72 and b) under NICE NG87 guidelines. In addition, secondary healthcare visits (inpatient, outpatient and A&E) will be grouped into mental disorders, accidents and injuries, and all other conditions.
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Prevalence and description of chronic obstructive pulmonary disease cohorts from 2000 to 2020 — Jennifer Quint ...
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Prevalence and description of chronic obstructive pulmonary disease cohorts from 2000 to 2020
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-26
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Philip Stone - Corresponding Applicant - Imperial College London
Michael Osen - Collaborator - British Lung FoundationOutcomes:
Prevalence of COPD captured in primary care records (when using either a validated definition of COPD or the QOF definition); Prevalence of COPD captured in secondary care records
Description: Technical Summary
The objective of this study is to obtain an up-to-date estimate of the prevalence of chronic obstructive pulmonary disease (COPD) in England, to understand the make-up of the COPD population, and to observe the temporal trends in annual prevalence over the past two decades (2000 to 2020). This study will be descriptive and use CPRD Aurum data linked with Hospital Episode Statistics (HES) Admitted Patient Care (APC) data. Annual COPD prevalence will be stratified by age, sex, region, socioeconomic status (using linked Index of Multiple Deprivation (IMD) data), COPD medication, and COPD severity (Medical Research Council (MRC) Grade, Global Initiative for Obstructive Lung Disease (GOLD) stage, and pulmonary rehabilitation referral status). COPD prevalence will be determined for each year between 2000 and 2020, inclusive, using a validated disease definition of Read V2 codes. We will also determine prevalence based on a disease definition using Quality and Outcomes Framework (QOF) codes, and symptom codes in smokers without a diagnosis of asthma. We will also capture the prevalence of COPD in secondary care records (HES) relative to primary care. The overall annual number of adults registered in the CPRD will be used as the denominator. Additionally, the prevalence of patients having â¥1 moderate or severe COPD exacerbation per year will be calculated by calendar year. We will consider using logistic regression to estimate changes in prevalence of COPD-related events across time and to estimate changes in COPD diagnosis based on case finding and spirometry testing, if appropriate and numbers allow. This will benefit public health as it will reveal the burden to the NHS of COPD, and therefore inform appropriate resource allocation.
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Early warning score for Autism Spectrum Disorder using real-world data — Yajing Zhu ...
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Early warning score for Autism Spectrum Disorder using real-world data
Datasets:GP data, CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-19
Organisations:
Yajing Zhu - Chief Investigator - Roche
Yajing Zhu - Corresponding Applicant - Roche
Christopher Chatham - Collaborator - F. Hoffmann - La Roche Ltd
Kelly Zalocusky - Collaborator - Genentech - Roche CompanyOutcomes:
Time to diagnosis of Autism spectrum disorders
Description: Technical Summary
Early diagnosis of ASD would allow for early intervention so that children can fully leverage the developmental window to improve faster. Current ASD-specific screening tools have been ineffective, with poor sensitivity and low positive predictive value. This study will fully leverage the personal history of the evolution of conditions in the UK population to assess their potential to provide an early diagnosis. We will develop an early warning scoring system for the prediction of ASD based on a Cox proportional hazards model with time-varying covariates, where both linear and non-linear specifications (e.g. interaction between risk factors) will be explored. We will demonstrate the performance of this system through a robust validation design and by comparing it with existing ASD screening methods (e.g. the modified checklist for Autism in toddlers) and recently developed algorithms in the literature.
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Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination — Olaf Klungel ...
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Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-15
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht UniversityOutcomes:
COVID disease; Multisystem inflammatory syndrome; Acute respiratory distress syndrome;Acute cardiovascular injury (including microangiopathy, heart failure, stress cardiomyopathy, coronary artery disease, arrhythmia, myocarditis); Coagulation disorders ( including deep vein thrombosis, pulmonary embolus, cerebrovascular stroke, haemorrhagic disease, cerebral vein sinus
thrombosis, disseminated intravascular coagulation); Generalised convulsion ; Guillain Barré Syndrome; Diabetes (type 1); Acute kidney injury; Acute liver injury; Anosmia, ageusia ; Chilblain-like lesions; Single organ cutaneous vasculitis ;Erythema multiforme
Anaphylaxis; Death (any cause) ;Sudden death (by codes) ;Acute aseptic arthritis ;Meningoencephalitis ;Acute disseminated encephalomyelitis (ADEM);Narcolepsy ;Thrombocytopenia;Transverse myelitis;Bellsâ palsyDescription: Technical Summary
The global rapid spread of COVID-19 caused by the SARS-CoV2 triggered the need for developing vaccines to control for this pandemic. This study will generate incidence rates of adverse events of special interest (AESI) prior to and after COVID-19 vaccination, to facilitate monitoring of the benefit-risk profile of licensed COVID-19 vaccines.
The objectives of this study are to monitor and estimate the incidence rates of adverse events of special interest (AESI), diagnosed COVID-19 in vaccinated and non-vaccinated persons by data source over the period January 1st 2020-October 31st 2021 by brand and dose of vaccine and age of the population. We will further stratify by the at-risk population for developing severe COVID-19 by data source, brand and dose of vaccine as well as age.
Study design:
A retrospective, multi-database, dynamic cohort study in 4 data sources in 4 European countries (Italy, Netherlands, Spain, United Kingdom).Variables:
Variables of interest will be:
⢠Person-time: birth and death dates as well as periods of observation.
⢠Events: dates of medical and/or procedure and/or prescription/dispensing codes to identify AESI, COVID-19 and at-risk medical conditions.
⢠Vaccines: vaccine brands and batch numbers (where possible)Data analysis:
Incidence rates of listed AESI will be calculated in non-exposed time periods (prior to vaccination or in non-vaccinated) and during each one-week risk window since vaccination by each dose, stratified per brand of vaccine. Data on vaccine exposures (doses), incidence rate of diagnosed COVID-19 and each AESI of interest by time since vaccination dose will be displayed on a dashboard. Incidence rates (and 95%CI) of COVID-19 and AESI among at-risk populations (in terms of comorbidity and by age) will also be computed.
Source -
How many UK adults developed kidney failure since the year 2000? What treatments did they receive and what were their health outcomes? — Fergus Caskey ...
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How many UK adults developed kidney failure since the year 2000? What treatments did they receive and what were their health outcomes?
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-02
Organisations:
Fergus Caskey - Chief Investigator - University of Bristol
Barnaby Hole - Corresponding Applicant - University of Bristol
Ailish Nimmo - Collaborator - University of Bristol
Lucy Plumb - Collaborator - University of Bristol
Tim Jones - Collaborator - University of BristolOutcomes:
Kidney specialist review;
Dialysis receipt;
Kidney transplantation;
All cause mortality, cause and date of death;
Hospital admissions and total hospital days;
Primary care attendance;
Diabetology review;
Palliative care input;
Blood pressure control;
HbA1c;
Markers of renal anaemia: haemoglobin level, ferritin;
Markers of renal bone disease: calcium, phosphate and parathyroid hormone;
Serum potassium;
Medications prescribed.Description: Technical Summary
The UK Kidney Association is extending quality assurance to all individuals reaching kidney failure. Dialysis and transplantation are nationally audited, but the population that does not receive dialysis/transplantation is not captured. The characteristics, healthcare and outcomes for this latter group are poorly documented in the UK. Studies in Canada and Australia suggested as many reach kidney failure and die as those who start dialysis or receive a transplant. This work will provide vital data to inform national kidney service planning, by capturing and describing the population of individuals in CPRD who reach kidney failure, and by unpacking the associations between patient factors and access to specialist services.
Aim:
⢠Use CPRD and HES to describe the demographic, clinical and treatment characteristics of the population within CPRD that developed kidney failure since 31st December 1999.Population:
⢠Individuals in CPRD Gold/Aurum incident to kidney failure, defined by kidney function (eGFR) <15, initiation of dialysis, or kidney transplantation.Objectives:
⢠Estimate the total UK population incident to kidney failure.
⢠Compare treatment and outcomes of individuals stratified by specialist review, and by receipt of dialysis/transplantation.
⢠Analyse the association between patient factors and review by a kidney specialist; and initiation of dialysis/transplantation.The first two objectives involve descriptive statistics only. Primary analysis will be conducted using all CPRD-registered practices. Secondary analyses will restrict to individuals with HES linkage. Incidence rates by age/sex/ethnicity from the CPRD data will be applied to the UK population (from the UK census) to estimate UK-wide incidence.
The final objective will apply logistic regression to assess the hypotheses that the likelihood of ever receiving specialist review, or ever receiving dialysis/transplantation [co-primary outcomes] are associated with the age, sex, ethnicity, index of multiple deprivation, Charlson comorbidity index, and electronic frailty index of an individual reaching kidney failure [exposures].
Source -
UKPREG: UKPREGnancy study - a longitudinal international registry-based cohort study of pregnancy and heart disease — Teresia Svanvik ...
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UKPREG: UKPREGnancy study - a longitudinal international registry-based cohort study of pregnancy and heart disease
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-03
Organisations:
Teresia Svanvik - Chief Investigator - University of Oxford
Teresia Svanvik - Corresponding Applicant - University of Oxford
Becky MacGregor - Collaborator - University of Warwick
Marian Knight - Collaborator - University of Oxford
Sarah Hillman - Collaborator - University of Warwick
Outcomes: Primary outcomes
Miscarriage; abortion; hypertension in pregnancy; pregnancy-induced hypertension; pre-eclampsia; eclampsia; haemolysis elevated liver enzymes low platelet (HELLP) syndrome, placental abruption; anaesthesia; general anaesthesia; regional anaesthesia; mode of delivery; post-partum haemorrhage; stillbirth/live birth; full term birth; gestational age at birth; Apgar score <7 at 5 minutes; small for gestational age (SGA); birth weight; prevalence of heart disease; further cardiac events; further cardiac admission.
Secondary outcomes
Maternal death within 42 days post-partum; maternal death >42 days to one year postpartum; admission to hospital with mental health diagnose; foetal mortality; neonatal mortality; cause-specific mortality; all-cause mortalityDescription: Lay Summary
The aim of this study is to examine outcomes for the mother, her new born and her heart, in women with heart disease (HD), in order to develop actions to lower the rate of health complications.
Technical Summary
The research questions that will be answered in this project are:
1. How many pregnant women have a diagnose of HD?
2. What are the differences in maternal and new born outcomes among women with HD compared to women without HD?
3. What are the differences in maternal and new born outcomes among women with HD from various ethnic and socioeconomic groups?
4. What are the differences in trends and long-term outcomes of pregnancy and birth in different types of HD?
This will be a retrospective, observational cohort study, including women in the UK and Sweden that have undergone pregnancy and birth between 2000-2020, diagnosed with HD who are included in the CPRD or the Swedish Medical Birth Register.
This project will contribute with numbers of pregnant women diagnosed with and severity of various HD, between different ethnic and socioeconomic groups of women with HD and long-term outcome of HD among women that have undergone pregnancy and birth. A comparison between the UK and Sweden could result in actions to reduce the number of maternal deaths due to HD. This project will lead to a more adequate risk assessment of women with HD that consider pregnancy and generate information both to help plan services in the future and counsel affected women.The aim of this study is to lower the rate of maternal morbidity and mortality and the results could lead to a more nuanced risk assessment of women with heart disease (HD) that consider pregnancy and generate information to help plan services and counsel affected women.
The research questions are:
1. What is the prevalence of HD among pregnant women in the UK and Sweden?
2. What are the differences in obstetric and foetal outcomes among women with HD
- compared to women without HD in the UK and Sweden?
- from various ethnic, immigrant and socioeconomic groups in the UK and Sweden?
3. Is the gap between the most and the least deprived women with HD that have undergone pregnancy lesser in Sweden compared to the UK?
4. What are the differences in trends and long-term outcomes of pregnancy in different HD in the UK and Sweden?
This will be a retrospective, observational cohort study of women with and without HD in the UK and Sweden who have undergone pregnancy between 2000-2020, and are included in the CPRD or the Swedish Medical Birth Register and those who have no diagnosis of HD. De-identified UK data from general practitioners will be linked to Hospital Episode Statistics data. The Swedish data will be linked to national health registers.
The sample size will be governed by the size of the datasets. Descriptive analyses will include prevalence of heart disease, maternal characteristics presented as frequencies and percentages, cardiac events and admissions together with mortality data presented with Cumulative incidence function curves. Comparison between groups will be analysed by Chi-square test, T-test, Mann-Whitney U- test, Log-rank and Cumulative incidence function tests as appropriate. Poisson regression for rate ratios, multinomial logistic regression for odds ratios, and survival analysis for time-to-event outcomes will be used.
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Long-term health in cancer survivors compared with the general population: matched cohort study using linked UK electronic health records — Krishnan Bhaskaran ...
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Long-term health in cancer survivors compared with the general population: matched cohort study using linked UK electronic health records
Datasets:GP data, The outcomes for comparisons between cancer survivors and cancer-free controls will be vascular-related diseases (in particular kidney disease [primary renal outcome acute kidney injury], vascular/overall dementia), and mental health-related outcomes (depression, anxiety, cognitive impairment, fatigue, pain (including opioid prescription), sleep disturbance, sexual dysfunction, and fatal and non-fatal self-harm). The outcomes for comparisons between patients receiving different anti-cancer treatments are venous thromboembolism, heart failure, arrhythmia, coronary artery disease, stroke.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-30
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Garth Funston - Collaborator - University of Cambridge
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The outcomes for comparisons between cancer survivors and cancer-free controls will be vascular-related diseases (in particular kidney disease [primary renal outcome acute kidney injury], vascular/overall dementia), and mental health-related outcomes (depression, anxiety, cognitive impairment, fatigue, pain (including opioid prescription), sleep disturbance, sexual dysfunction, and fatal and non-fatal self-harm). The outcomes for comparisons between patients receiving different anti-cancer treatments are venous thromboembolism, heart failure, arrhythmia, coronary artery disease, stroke.
Description: Technical Summary
In recent decades, treatment of many cancers has improved dramatically, so that there are increasing numbers of people surviving long-term after cancer. But cancer and its treatment may have long term effects on both physical and mental health. This study aims to investigate whether cancer survivors have more (i) vascular-related diseases, or (ii) mental health problems, compared with people who have never had cancer. We will employ a matched cohort design, with cancer and non-cancer cohorts selected from routinely collected data from GPs, linked to Hospital Episodes Statistics (HES) Admitted Patient Care, cancer registration, and ONS death registration data. Cancers will be identified using GP, HES and cancer registry data; outcomes will be identified in GP, HES, and ONS mortality data. Relative risks of vascular- and mental health-related outcomes will be estimated with Cox proportional hazards models. To investigate whether cancer survivors exposed to specific treatments (e.g. chemotherapy) are at greater non-cancer morbidity, we will conduct a cohort study among cancer survivors only. Exposure to treatment will be ascertained using the recently established linkages to the RadioTherapy DataSet (RTDS) and Systemic Anti-Cancer Therapies dataset (SACT). Vascular- and mental health-related outcomes will be defined as in the matched cohort study. Hazard ratios will be computed using Cox regression models. The results of this work will help cancer survivors and their doctors to better understand the problems that can arise after cancer, who is likely to be most at risk, and can inform mitigation strategies.
Source -
Characterising the risk of malignancy in patients with atopic dermatitis prescribed immune suppressive medications — Simon Wan Yau Ming ...
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Characterising the risk of malignancy in patients with atopic dermatitis prescribed immune suppressive medications
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-22
Organisations:
Simon Wan Yau Ming - Chief Investigator - Health iQ
Simon Wan Yau Ming - Corresponding Applicant - Health iQ
Rebeka McClintock - Collaborator - Health iQOutcomes:
Time to cancer diagnosis
Incidence of cancer
Time to haematological cancer diagnosis
Incidence of haematological cancer diagnosis
Ranked analysis of cancer diagnosisDescription: Technical Summary
Atopic dermatitis is a common condition affecting 11-20% of children and 5-10% of adults in the United Kingdom. Treatment varies upon severity, with initial treatment prescribed in primary care being emoillients and topical corticosteroids. In a proportion of patients, this treatment is insufficient, and the patient continue to suffer from itching, dry skin, bleeding, recurrent skin infections, pain, sleep disturbance, reduced quality of life and work productivity. In moderate and severe atopic dermatitis that is refractory to topical corticosteroids, there are a number of treatment modalities including UV light treatment, calcineurin inhibitors, immune suppressive therapies (IST) and biologics. Immune suppressive medications have been linked to increased risk of malignancy. Interestingly, patients with rheumatoid arthritis prescribed IST have a reduced incidence of cancer compared to those who do not receive these medications. To date, studies examining the association of IST in patients with atopic dermatitis with cancer have been limited to 24 months. Considering that the development of malignant lesions can take many years, there is a need to research whether there is an association over a long time period.
By utilising CPRD we will be able to characterise patients with atopic dermatitis, if they have a diagnosis of cancer, and the dates of cancer. Since electronic healthcare records document prescription of IST under shared care pathways, we will be able to establish an association between IST and the time until cancer or potent steroid until cancer. Patients with moderate/severe atopic dermatitis, identified through the use of potent steroids will be grouped into a cohort of patients on ISTs and those who are not. Patients will be matched on comorbidities that may be linked to cancer and the cohorts compared through a cox proportional hazards model. An additional analysis will be conducted using inverse probability weighting for the same cancer outcome.
Source -
Comparative effectiveness of second line glucose lowering therapies on preserving renal function in patients with type 2 diabetes — Chintan Dave ...
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Comparative effectiveness of second line glucose lowering therapies on preserving renal function in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-16
Organisations:
Chintan Dave - Chief Investigator - Rutgers, The State University of New Jersey
Julia Liaw - Corresponding Applicant - Rutgers, The State University of New Jersey
Abner Nyandege - Collaborator - Rutgers, The State University of New JerseyOutcomes:
Reduction in kidney function by 30% of its baseline value (primary endpoint); reduction in kidney function by 40%, 50% and 57% of its baseline value (secondary endpoints).
Description: Technical Summary
Renal disease is a common complication of type 2 diabetes (T2DM) affecting one in three patients. In fact, the global rise in the incidence of end-stage renal disease, dialysis, and renal transplantations can be attributed primarily to the increasing prevalence of T2DM. The co-occurrence of T2DM and chronic kidney disease augurs a long-term clinical course characterized by greater insulin resistance, accelerated progression of T2DM, and an increased risk of developing cardiovascular disease (CVD). The recent publication of landmark clinical trials has shown that certain glucose lowering agents â such as sodium/glucose cotransporter-2 inhibitors (SGLT2i) and glucagon like peptide 1 receptor agonists (GLP-1RA) reduce the incidence of adverse renal events. However, it is currently unclear whether these benefits observed in certain high-risk populations (e.g. established cardiovascular disease) in clinical trials are also evident among patients in the real world.
Thus, the overall purpose of this study is to examine the comparative effectiveness of SGLT2i (exposure) compared to non-SGLT2i second-line glucose lowering therapies (control group) in preserving renal function among patients with type 2 diabetes. To achieve this objective, we will conduct a retrospective, population-based cohort study using CPRD Gold data to generate a cohort of patients initiating the medications of interest. Thereafter, we will employ a 1:1 nearest neighbour propensity score matching approach to adjust for relevant confounders, and Cox proportional hazard models to estimate adjusted hazard ratios for the outcomes of interest. The primary outcome of interest is defined as a 30% reduction in renal function from its baseline value. Successful competition of this study will generate robust and timely data on the renal effectiveness of second-line glucose lowering therapies, allowing patients and clinicians to make more informed evidence-based healthcare decisions.
Source -
Real-World Open Angle Glaucoma (OAG) Disease Management, Treatment Patterns, Resource Utilization, and Outcomes from Primary Care through to Secondary Care in the UK Setting — Camelia Graham ...
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Real-World Open Angle Glaucoma (OAG) Disease Management, Treatment Patterns, Resource Utilization, and Outcomes from Primary Care through to Secondary Care in the UK Setting
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-19
Organisations:
Camelia Graham - Chief Investigator - Parexel International LLC
Edon Morina - Corresponding Applicant - Parexel Denmark A/S
Ron Stewart - Collaborator - Parexel International LLC
Shea O'Connell - Collaborator - HERON Evidence Development LtdOutcomes:
The outcomes to be measured are 1) intraocular pressure control; 2) disease severity as measured by: visual field progression, intraocular pressure (IOP); cup-to-disc (CD) ratio; reduction in retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) thickness; and 3) adverse events that may be related to eye drop treatment, including: conjunctival allergies, conjunctival injection; corneal epithelium disorders; blepharitis; ocular pemphigoid; corneal sensitivity; corneal epithelium disorders; relaxation bronchial; urinary; and vascular smooth muscles; bradycardia; blood pressure decrease; irregular pulse; increase in asthma attacks; chronic obstructive pulmonary disease; headaches; depression; anxiety; confusion; dysarthria; hallucinations; somnolence tendencies; and lethargy.
Please see the list of variables here and the codes for these variables in the Appendices:
⢠Visual Field
⢠Intraocular Pressure Control
⢠Disease Severity (Visual Field Progression)
⢠IOP
⢠CD Ratio
⢠Reduction in RNFL and GCL thickness
⢠Conjunctival allergies
⢠Conjunctival injection
⢠Blepharitis
⢠Ocular pemphigoid
⢠Corneal sensitivity
⢠Corneal epithelium disorders
⢠Relaxation bronchial, urinary, and vascular smooth muscles
⢠Bradycardia
⢠Blood pressure decrease
⢠Irregular pulse
⢠Increase in asthma attacks
⢠Chronic obstructive pulmonary disease
⢠Headaches
⢠Depression
⢠Anxiety
⢠Confusion
⢠Dysarthria
⢠Hallucinations
⢠Somnolence tendencies
⢠LethargyDescription: Technical Summary
Early diagnosis and treatment of patients with glaucoma can improve health outcomes, including disease progression, over time.The purpose of this study is to estimate the burden of disease for patients diagnosed with glaucoma and to better understand its economic impact to the healthcare system in England and Wales. The findings from this study would improve patient care for patients diagnosed with glaucoma and/or ocular hypertension in England and Wales by directly informing clinical practices about best practices for optimal health outcomes, resource utilization, cost, and treatment options when specific modes of administration are not feasible.
Two cohorts will be built for the study during the time period of interest, January 1, 2014 âDecember 31, 2019. The first cohort will be built from the CPRD Aurum data linked to the HES datasets (Admitted patient care: January 2014 to December 2019. Data collected from Cohort 1 and Cohort 2 will include patient-level characteristics, glaucoma treatment data, visits to health care provider(s), and relevant procedures. Patient variables from Cohort 1 will be used to match to Cohort 2 using probabilistic matching methods. Data from both cohorts will remain de-identified and no direct patient-level match between Cohort 1 and Cohort 2 will occur. The patient cohorts will be stratified at index by exposure to prescription eyedrop treatment, eyedrop tolerance, and eyedrop installation ability. Eyedrop prescriptions categories for the study are prostaglandin analogues, beta blockers, alpha agonists, carbonic anhydrase inhibitors, and rho kinase inhibitors. The clinical outcomes of interest are intraocular pressure control, disease severity (visual field progression), and potential adverse events. Chi square and multivariate analyses will be done to identify statistically significant differences and/ or potential associations of treatments with outcomes or time to change in intraocular pressure control, visual field progression, and specific adverse events found to be associated with treatment.
Source -
Descriptive analysis of trends in health care use in England by ethnicity and deprivation over the austerity period culminating in the COVID-19 pandemic — Miqdad Asaria ...
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Descriptive analysis of trends in health care use in England by ethnicity and deprivation over the austerity period culminating in the COVID-19 pandemic
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-09
Organisations:
Miqdad Asaria - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Ann Raymond - Collaborator - The Health Foundation
Laurie Rachet-Jacquet - Collaborator - The Health Foundation
Stephen Rocks - Collaborator - The Health Foundation
Toby Watt - Collaborator - The Health FoundationOutcomes:
Primary care consultation rates â key variables: age; sex; ethnicity; patient-level Index of Multiple Deprivation; outcome of consultation (referral, prescribing, test, immunisation); the presence of pre-existing long-term condition: Cancer, Diabetes, Heart Failure, Coronary Heart Disease, Atrial Fibrillation, Asthma, Chronic Obstructive Pulmonary Disorder, Stroke, Chronic Kidney Disease, Chronic Liver Disease, Depression, Anxiety, Dementia
Accident and emergency visit rates â key variables: age; sex; ethnicity; patient-level Index of Multiple Deprivation; outcome of visit (admission/discharge)
Outpatient hospital admission rates â key variables: age; sex; ethnicity; patient-level Index of Multiple Deprivation; outcome of consultation (admission/discharge)
Inpatient hospital admission rates â key variables: age; sex; ethnicity; patient-level Index of Multiple Deprivation; emergency/elective admission type; diagnosis codes (ICD 10); procedure codes (OPCS); length of stay; HRG (for linking to reference costs)
Mortality rates - key variables: age; sex; ethnicity; patient-level Index of Multiple Deprivation; causes of death (ICD 10)Description: Technical Summary
The aim of the study is to produce summary statistics on the trends in use of primary care, secondary care and mortality at a high level, by age, sex, deprivation and ethnicity:
1. Primary care consultation rates and outcomes (referrals, prescribing, tests, immunisation),
2. Accident and emergency visit rates and outcomes (admission, discharge)
3. Outpatient hospital visit rates and outcomes (discharge, referral, etc.)
4. Emergency inpatient admissions and diagnosis
5. Elective inpatient admissions and diagnosis
6. Mortality rates and causesWe will summarise mean and standard errors of the rates of 1-6 above each year between 2010 and 2019 and compare with COVID-19 related hospitalisations and mortality in 2020/2021. We will do this in each combination of age, sex, ethnicity and deprivation group to describe how health care use has changed over time for different groups in the population prior to austerity and to explore whether this is indicative of an erosion of health that was associated with worse outcomes during the pandemic.
Source -
Multimorbidity between chronic diseases in the ageing populations — Ioanna Tzoulaki ...
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Multimorbidity between chronic diseases in the ageing populations
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-22
Organisations:
Ioanna Tzoulaki - Chief Investigator - Imperial College London
Bowen Su - Corresponding Applicant - Imperial College London
Abbas Dehghan - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College LondonOutcomes:
Our outcome of interest is multimorbidity. We will use the definition of multimorbidity recommended by WHO, which is the âco-existence of two or more conditions in the same individualâ.
Description: Technical Summary
This study will be a retrospective longitudinal cohort analysis. The overall aim is to investigate the occurrence and patterns of multimorbidity and explore the determinants of these clusters using routine UK primary care data. Our outcome of interest will include participants with multimorbidity which defined as coexistence of the following chronic diseases: cardiovascular diseases (CVD), cancer, arthritis, diabetes, respiratory diseases, neurological diseases and mental health conditions. Participants with at least 5 years follow-up and no disease diagnosed within 12 months after their first GP practice registration were included. We will first describe multimorbidity by participantsâ baseline characteristics. Continuous variables (i.e. age and years of follow-up) will be expressed as means and standard deviations (SD), and categorical variables (i.e. gender, BMI, smoking status and alcohol consumption) were expressed as number and percentage (%). Differences will be evaluated using the Kruskal-Wallis test or Ï2 test as appropriate. Prevalence of multimorbidity will be inferred from cumulative incidence, with multimorbidity cases removed only at death and tabulated by different age and gender groups. Poisson regression models, with the Huber variances, will be employed to measure the progress and level of multimorbidity (defined as the number of diseases that a patient has ever had). The patterns of multimorbidity in terms of chronological order and disease patterns will be examined using the latent class models for clustering and dynamic Bayesian networks. Multistate survival model is used to investigate transactions from baseline to the index condition and from index condition to the second condition.
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Use of machine learning to improve the prediction of 10-years Cardiovascular Disease risk using data from Electronic Health Records — Vasa Curcin ...
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Use of machine learning to improve the prediction of 10-years Cardiovascular Disease risk using data from Electronic Health Records
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-22
Organisations:
Vasa Curcin - Chief Investigator - King's College London (KCL)
Tianyi Liu - Corresponding Applicant - King's College London (KCL)
Abdel Douiri - Collaborator - King's College London (KCL)
M. Jorge Cardoso - Collaborator - King's College London (KCL)Outcomes:
1. Cardiovascular events:
⢠Coronary (Ischaemic) Heart Disease; chronic/unstable angina; myocardial infarction (MI)
⢠Cerebrovascular disease; transient ischaemic attack (TIA); stroke
⢠Peripheral arterial disease; aortic disease; abdominal aortic aneurysms (AAA)
2. Cardiovascular disease (CVD) mortality
3. Composite major cardiovascular disease event: a composite of cardiovascular death, fatal and non-fatal stroke, Myocardial infarction, and heart failureDescription: Technical Summary
This study focuses on improving the cardiovascular risk prediction algorithm using the deep learning approach in the electronic health records data linkage. Contemporary cardiovascular prediction models use the conventional method such as Cox proportional hazard models (e.g. QRISK, Framingham risk score, SCORE, and ACC/AHA) or use an advanced technique without sufficient model comparison and external validating. Cardiovascular risk scores like QRISK and ACC/AHA are comparably more robust and have been widely used in the UK and USA clinical practice. This study will compare the models comprehensively to see whether using deep learning models can truly improve accuracy. To achieve that, several previously studied models are selected including naïve Bayes, decision tree, random forest, K-nearest neighbours, logistic regression, support vector machine, gradient boosting algorithms, and neural networks. CPRD, HES and ONS datasets will provide the baseline characteristic, in/outpatient information, and death registration of the patients. 10-years cardiovascular risk will be predicted. The predictor variables selection will be based on the well-accepted risk factors of cardiovascular disease and variables that show a significant association with previous studies' cardiovascular disease outcome. Models based on different approaches will be developed in the training dataset and generate the AUC curve in the testing dataset. The final model selection will be carried out in a manner of prediction performance comparison. After deciding the selected models, we will also investigate the performance of it in the different sub-types of cardiovascular diseases. This process is used to further discuss the possibility of transferring the 'knowledge' to other related disease prediction (e.g. vascular dementia).
Source -
Pregnancy induced hypertension, gestational diabetes, and the risk of chronic kidney disease: A population-based study using the Clinical Practice Research Datalink. — Deirdre Lane ...
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Pregnancy induced hypertension, gestational diabetes, and the risk of chronic kidney disease: A population-based study using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-09-09
Organisations:
Deirdre Lane - Chief Investigator - University of Liverpool
Jose Ignacio Cuitun Coronado - Corresponding Applicant - University of Liverpool
Deirdre Lane - Collaborator - University of Liverpool
Gregory Lip - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of Liverpool
Stephanie Harrison - Collaborator - University of Liverpool
Tariq Al Bahhawi - Collaborator - University of LiverpoolOutcomes:
Chronic Kidney Disease. It will be the primary outcome, defined by recorded diagnoses of chronic kidney disease, as well as measures of the estimated glomerular filtration rate, using SNOMEDCT codes.
Description: Technical Summary
Pregnancy-induced hypertension (PIH) affects 5-10% of all pregnant women worldwide and is associated with chronic kidney disease (CKD) and/or gestational diabetes. In the United Kingdom (UK), about 16 out of every 100 pregnant women will develop gestational diabetes. Between 2015 and 2017, about 9.6 women per 100,000 died during pregnancy. In 2016, women aged 35 and over had a higher prevalence of CKD compared to men (17% vs 12%).
Research has reported that women with gestational diabetes have 6.1 higher rates of pre-eclampsia and up to nine-fold increased risk of CKD. Moreover, women who had pre-eclampsia have 4.9 higher risk of end-stage kidney disease and 3.6 times higher in women who had gestational hypertension.
The overall objective of this study is to use Hospital Episode Statistic (HES)-linked Clinical Practice Research Datalink (CPRD) data to conduct a descriptive cohort study to describe the associations between PIH (pre-eclampsia), gestational diabetes, and CKD in women aged 18 or older with a diagnosis of PIH (pre-eclampsia) in their first known pregnancy. We will investigate womenâs risk of developing CKD when they experience PIH or gestational diabetes.
Means and standard deviations will be used to produce and describe changes, generalized linear models (GLM) will be used to describe participantâs baseline characteristics. Cox proportional hazards regression models will be used to investigate the associations between PIH (pre-eclampsia), gestational diabetes, and the risk of CKD. Baseline will start from 1st January 1998 and participants will be censored at the date of CKD diagnosis, death, or end of the study period, defined as the last date of follow-up or 31 December 2019, whichever comes first.
Kaplan-Meier curves will be fitted to compare the association between PIH (pre-eclampsia), gestational diabetes, and risk of CKD. PIH (pre-eclampsia) will be treated as time-varying during the follow-up time.
Source -
Postcode sector ethnicity breakdown
— Westminster City Council...
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Postcode sector ethnicity breakdown
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Royal Borough of Kensington and Chelsea.
Source -
Understanding the equity of access to diagnostics in NW London — Imperial College Healthcare NHS Trust...
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Understanding the equity of access to diagnostics in NW London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Community diagnostic hubs in NW London.
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Hounslow ICP: Population Health Management Workstream — London Borough of Hounslow...
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Hounslow ICP: Population Health Management Workstream
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: London Borough of Hounslow
Description: Hounslow Health and Care.
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Evaluation of potential benefit of using machine learning algorithm to aid Atrial Fibrillation screening — Chelsea and Westminster Hospital NHS Foundation Trust...
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Evaluation of potential benefit of using machine learning algorithm to aid Atrial Fibrillation screening
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Atrial fibrillation .
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Older people and care home needs assessment — Westminster City Council...
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Older people and care home needs assessment
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Care in Kensington and Chelsea and Westminster .
Source -
Type 2 Diabetes Exemplar: A Remote Care Service for North West London (T2DEx)
— Imperial College London...
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Type 2 Diabetes Exemplar: A Remote Care Service for North West London (T2DEx)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Diabetes.
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Analysing Fungal Disease Epidemiology in the UK
— Royal Brompton Hospital...
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Analysing Fungal Disease Epidemiology in the UK
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-21
Opt Outs: no information provided./p>
Organisations: Royal Brompton Hospital, Guy’s and St. Thomas’ NHS Foundation trust
Description: Fungal disease. Commercial
Source
2021 - 08
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ADR UK Research Fellows: Methodological developments within administrative data research — unknown...
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ADR UK Research Fellows: Methodological developments within administrative data research
Where: unstated
When: 2021-8-9
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding three research teams as part of the Economic & Social Research Council (ESRC) Research Methods Development Grants.
The research teams are being funded to address methodological challenges related to ADR UKâs mission to join up the abundance of administrative data already being created by government and public bodies across the UK and make it available for research in the public interest. This is being done via the development of new research methods; the application of existing methods in a novel way; and the development of our understanding of methodological challenges.
Read about the projects being funded via the scheme below.
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Association between degree of weight loss and reduction in risk of developing obesity related complications in adults living with obesity — Camilla Morgen ...
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Association between degree of weight loss and reduction in risk of developing obesity related complications in adults living with obesity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Camilla Morgen - Chief Investigator - Novo Nordisk
Camilla Morgen - Corresponding Applicant - Novo Nordisk
Anette Varbo - Collaborator - Novo Nordisk
Christiane L Haase - Collaborator - Novo Nordisk
Kamlesh Khunti - Collaborator - University of Leicester
Kasper Matthiessen - Collaborator - Novo Nordisk
Naveen Rathor - Collaborator - Novo Nordisk
Volker Schnecke - Collaborator - Novo NordiskOutcomes:
Time to diagnosis with one of the following selected outcomes during follow-up:
1) T2D; 2) sleep apnoea; 3) hip/knee osteoarthritis; 4) hypertension; 5) dyslipidaemia; 6) unstable angina/MI (composite endpoint); 7) asthma; 8) atrial fibrillation; 9) heart failure; 10) venous thromboembolism; 11) CKD; 12) PCOS and 13) depression.
Description: Technical Summary
In a recent study using data from the UK CPRD and Hospital Episode Statistics (HES), we have shown that an intentional median 13% weight loss was associated with a risk reduction for type 2 diabetes (T2D) (40%), sleep apnoea (40%), hypertension (22%), dyslipidaemia (19%) and asthma (18%), when compared to keeping a high stable weight.
In this study we will examine how different degrees of weight loss (via behavioural changes, anti-obesity medication or bariatric surgery) among adults with obesity may translate into health benefits. In a prospective cohort design we will investigate the associations between weight loss between 5-50% and onset of 13 selected obesity related complications. We will examine if associations differ by initial BMI (e.g. 30,40 or 50 kg/m2) and how the associations differ with different obesity related complications.
We will include adults (18-70 years of age) who have a BMI record between January 2001 and December 2010, and a subsequent BMI record during year 4. Given the mean BMI during year 1 and the observed change between year 1 to 4, we will use Cox proportional hazard models to estimate the association between weight loss and the obesity related complications that occur after the four year baseline period: T2D, sleep apnoea, hip/knee osteoarthritis, hypertension, dyslipidaemia, unstable angina/myocardial infarction (MI; composite endpoint), venous thromboembolism, asthma, atrial fibrillation, heart failure, chronic kidney disease (CKD), polycystic ovary syndrome (PCOS) and depression. Underlying time scale is calendar time.
Analyses will be adjusted for: Index BMI, age, sex, smoking, ethnicity, socioeconomic status and baseline comorbidities.
We hypothesize that a weight loss will decrease the hazard ratio of obesity related complications.
The intended public health benefit is that the results can guide and motivate patients and health care professionals to initiate a lifestyle change or other types of treatment for individuals with obesity.
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Characterization of ezetimibe use in the United Kingdom: a retrospective database study — Christopher Morgan ...
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Characterization of ezetimibe use in the United Kingdom: a retrospective database study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Adeline Durand - Collaborator - Novartis UK
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Steven Tinsley - Collaborator - NOVARTISOutcomes:
Patient demographics; cardiovascular comorbidities; baseline lipid-lowering therapy, baseline biochemistry, therapy change, low-density lipoprotein cholesterol change, high-density lipoprotein cholesterol change, non-high-density lipoprotein cholesterol change, total cholesterol change, triglycerides change
Description: Technical Summary
Elevated LDL-C is a known risk factor for cardiovascular events such as myocardial infarction, stroke and consequent cardiovascular death. The effectiveness of lipid lowering strategies by dietary modification and/or therapeutic intervention has been established. Initial pharmacological treatment for elevated LDL-C is focused on statins. Ezetimibe monotherapy is recommended as an option for those patients who are contraindicated or statin intolerant while ezetimibe in combination with statins is recommended as an option for patients where statins alone fail to achieve sufficient LDL-C reduction. However, it is known that many patients with increased cardiovascular risk factors are not achieving guideline LDL-C target levels and many are untreated after discontinuing statin therapy. In this retrospective database study, we wish to profile ezetimibe use within a United Kingdom population represented in the Clinical Practice Research Datalink (CPRD) Aurum and GOLD databases. The case selection period will be from 1st January to 2003 to 31st December 2020. Incident initiators of ezetimibe will be selected by drug codes in the Therapy (GOLD) and Drug issue (Aurum) tables from patients classified as of acceptable status by CPRD with a minimum of 90 days wash-in prior to first-ever lipid lowering therapy. Ezetimibe initiation by year will be presented and demographic, therapy and clinical characteristics (including duration of prior lipid-lowering therapy, proportion estimated to be statin intolerant and nearest prior lipid test values) will be presented. Change in lipid levels will be compared pre- and post-ezetimibe initiation. Time to discontinuation will be presented in a Cox proportional hazards model. Characteristics of those discontinuing, including subsequent treatment patterns will be presented. Change in lipid levels will also be compared pre- and post-ezetimibe discontinuation. Index of multiple deprivation and HES inpatient data will linked data will be used to provide baseline characteristics. ONS mortality data will be used to censor patients.
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COVID-19 and incidence of venous thromboembolism (VTE) in the UK general population — Xiaohui Sun ...
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COVID-19 and incidence of venous thromboembolism (VTE) in the UK general population
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Xiaohui Sun - Chief Investigator - King's College London (KCL)
Xiaohui Sun - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
David Morris - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes:
Thank you for the helpful comments.
Read/SNOMED-CT codes for venous thromboembolic disease have been added as appendixes. We also request HES APC for case identification. ICD-10 code lists for VTE are added in appendixes.
Given that patient with a confirmed incident PE would necessarily receive anticoagulant treatments, we further restrict incident PE cases to the ones with relevant clinical diagnoses receiving at least one prescription of anticoagulant. In order to differentiate between PE and DVT being recorded as VTE, information on diagnostic assessments to establish PE diagnoses 90 days before and after the index date will be sought after from the Observation file of CPRD Aurum. Incident VTE cases with clinical tests documented for PE within 90 days receiving at least one prescription of anticoagulant will be classified as incident PE. The remaining incident VTE cases with investigatory tests for DVT within 90 days will then be categorised into DVT incidence group.
We now revise the outcomes to be measured into:
Clinical diagnoses of incident PE receiving at least one prescription for anticoagulant in CPRD Aurum dataset
Clinical diagnoses of incident VTE with diagnostic tests for PE within 90 days of index dates in CPRD Aurum dataset
Clinical diagnoses of incident VTE with diagnostic tests for DVT within 90 days of index dates in CPRD Aurum dataset
Clinical diagnoses of incident DVT in CPRD Aurum dataset
Record of concurrent DVT and PE in CPRD Aurum dataset
Clinical diagnoses of incident PE in HES APC
Clinical diagnoses of incident DVT in HES APC
Record of concurrent DVT and PE in HES APCDescription: Technical Summary
The SARS-CoV-2 virus, which causes Covid-19, enters the human body mainly through the respiratory system. Covid19 increases the risk of thromboembolic events by including an inflammatory and high hypercoagulable state, as has been reported among hospitalized Covid-19 patients. This has raised concerns that Covid-19 induced immune thrombosis may lead to increasing risks of venous thromboembolism (VTE). Additionally, given that the lockdown measures have adversely impacted peopleâs physical activity levels, and immobility is a proven risk factor for deep vein thrombosis (DVT), which in itself is a common precursor for pulmonary embolism (PE), it has been suspected that VTE incidence might be increasing among at-risk populations during the pandemic. We propose two related analyses with primary care electronic health records to test these hypotheses. We will conduct a cohort study using GP health records to map the chronological changes of VTE incidence from 1st January 2015 to 30th April 2021. An interrupted time series analysis will be conducted by fitting hierarchical Poisson regression models to estimate changes in VTE incidence after the first lockdown in March 2020 and during the first and second wave of Covid-19, adjusting for age group, sex, ethnicity and general practices. A matched cohort study will be conducted, comparing Covid-19 patients with controls, matched for age, sex and general practice, to compare the incidence of VTE cases in relation to Covid-19 exposure. The second study is nested within the longer period being from 29th January 2020 onwards. Because 29th January 2020 was the official date of the UK's first confirmed COVID-19 case. We will estimate the incidence rate ratio of VTE associated with Covid-19 diagnosis in the preceding 28 and 84 days, and compare Covid-19 patients with non-Covid-19 patients, matched for general practice and index date using Poisson regression models to quantify the relative rates of VTE.
Source -
Analysis of the Clinical Practice Research Datalink (CPRD Gold + Aurum) and Hospital Episode Statistics (HES) to provide real world evidence on disease progression and the burden of uncomplicated urinary tract infection (uUTI) — Fanny Mitrani...
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Analysis of the Clinical Practice Research Datalink (CPRD Gold + Aurum) and Hospital Episode Statistics (HES) to provide real world evidence on disease progression and the burden of uncomplicated urinary tract infection (uUTI)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Rural-Urban Classification
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Fanny Mitrani-Gold - Chief Investigator - GlaxoSmithKline - USA
Sue Beecroft - Corresponding Applicant - Harvey Walsh Ltd
Aruni Mulgirigama - Collaborator - GSK
Ashish Joshi - Collaborator - GlaxoSmithKline - USA
Daniel Gibbons - Collaborator - GSK
David Heaton - Collaborator - Harvey Walsh Ltd
David Webb - Collaborator - GlaxoSmithKline - UK
Mark Wilcox - Collaborator - University of Leeds
Viktor Chirikov - Collaborator - OPEN Health Group
Xiaocong Marston - Collaborator - Harvey Walsh LtdOutcomes:
The outcomes for the study for Objectives 1 and 2 will be HES hospitalization for E coli sepsis, acute pyelonephritis, or bacteremia during the 28-day uUTI episode.
Outcomes for Objective 3 will cover the burden of illness of community-acquired uUTI captured over the 28-day uUTI episode as well as 12 months post-diagnosis:
⢠Number of all-cause and UTI-specific hospital admissions
⢠Number of all-cause and UTI-specific admissions to high dependency/intensive treatment unit
⢠Number of all-cause and UTI-specific Accident and Emergency (A & E) attendances
⢠Number of all-cause and UTI-specific specialist consultations
⢠Number of all-cause and UTI-specific primary care (GP) consultations
⢠Cost of each component of health care resource utilizationDescription: Technical Summary
The study will use retrospective data of English adult and adolescent female patients with linkable Clinical Practice Research Datalink (CPRD)/ Hospital Episode Statistics (HES) data in the period January 1, 2018 through December 31, 2019.The study involves two parts.
Part 1 will use a cohort of adult and adolescent females diagnosed with uUTI caused by E. coli in a community setting (i.e. CPRD) and treated with oral antibiotic and will follow them over their index 28-day uUTI episode. The index uUTI date for the episode will be defined as the date of first uUTI medical code meeting the inclusion/exclusion criteria. This cohort will constitute the main study cohort and is relevant to Objectives 1 and 2.
Part 2 will use a retrospective observational cohort design with matched controls; uUTI patients from Part 1 (cases) will be matched to patients from the general English female population without UTI (controls) to assess the incremental health care burden due to uUTI. This part of the study is relevant to Objective 3.
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Parkinson's Disease in minority ethnic groups: understanding phenotypical traits and differences in outcomes to inform pathways of care — Victoria Haunton ...
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Parkinson's Disease in minority ethnic groups: understanding phenotypical traits and differences in outcomes to inform pathways of care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Victoria Haunton - Chief Investigator - University of Leicester
Jatinder Minhas - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - Leicester Diabetes CentreOutcomes:
Outcomes include falls, stroke, myocardial infarction, COVID-19 infection and mortality, CVD-related mortality, hospital admissions, and all-cause mortality.
Description: Technical Summary
The primary objective of this research is to understand whether differences exist in clinical presentation and referral patterns from primary to secondary care in United Kingdom Parkinson's Disease patients. Specifically, to assess referral patterns, duration of symptoms, diagnostic delays, and primary care visits in Parkinsonâs patients; and to see if these differ between ethnic groups.
Using HES- and ONS-linked data, clinical parameters will be examined for relationships with adverse cardiovascular outcomes in an effort to determine risk factor profiles.
The primary exposure of interest for this study will be ethnicity. The demographics of Parkinsonâs patients will be described for each ethnic group, and outcomes will include managed in secondary care, falls, stroke, myocardial infarction, CVD-related mortality, hospital admissions, referrals, primary care visits, symptom duration, and all-cause mortality. To assess for differences between ethnic groups logistic regression will be used for binary outcomes (eg patient managed in secondary care), survival analysis for time to event outcomes (e.g. all cause mortality) and poisson regression models will be used to assess differences in incidence rates (eg primary care visits). All models will be adjusted for potential confounders such as age and BMI.
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Epidemiology and healthcare resource utilisation associated with Duchenne muscular dystrophy — Christopher Morgan ...
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Epidemiology and healthcare resource utilisation associated with Duchenne muscular dystrophy
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-02
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Emily Crossley - Collaborator - Duchenne UK
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence; incidence; health resource utilisation; costs; cardiomyopathy; survival
Description: Technical Summary
NB MBL no longer required.
This study aims to describe the prevalence and incidence of Duchenne muscular dystrophy (DMD) and to estimate resource utilisation and associated costs associated with the condition compared to controls and also by severity of DMD proxied by ambulatory status. In addition, we wish to the understand long term health outcomes (cardiomyopathy and mortality) in female carriers of the dystrophin gene mutation. Patients with DMD and female carriers of the dystrophin mutation that are eligible for HES linkage, will be selected by medcode in the CPRD AURUM (Observation and Referral tables) For the DMD patient analysis, point prevalence will be calculated for 2020 for all patients registered at an Aurum practice on 30th June 2020. Incidence of DMD will be described from 2010-20 based on patients registered at a contributory practice on their birth year. Non-DMD exposed controls will be matched by primary care practice, age, gender and current practice registration. Inpatient, outpatient and accident and emergency contacts will be extracted from the relevant linked Hospital Episode Statistics (HES) datasets and costed using standard NHS tariffs. Rates will be compared with non-exposed controls using Poisson distribution and associated costs will be compared using the Gamma distribution. Patients will be classified by ambulatory status based on relevant medcodes in the Aurum dataset and/or ICD-10 codes in the HES inpatient dataset and, in a sensitivity analysis, by age, and changes in primary and secondary care resource use and associated costs compared. For females carriers of the dystrophin gene mutation, non-exposed controls will be matched by age, primary care practice and current registration and crude rates of cardiomyopathy (attributed from either the Aurum Observation table or HES admitted patient care dataset) and mortality presented and time to event using a Cox Proportional Hazards Model.
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Differences in morbidity and mortality in men and women with chronic obstructive pulmonary disease and peripheral arterial disease — Jennifer Quint ...
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Differences in morbidity and mortality in men and women with chronic obstructive pulmonary disease and peripheral arterial disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-02
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Laura Portas - Collaborator - Imperial College LondonOutcomes:
The primary outcome is all-cause mortality
The secondary outcomes are 1)Cardiovascular specific mortality 2) acute limb ischaemiaDescription: Technical Summary
The aim of this study is to describe the differences in morbidity and mortality in men and women with both chronic obstructive pulmonary disease (COPD) and peripheral arterial disease (PAD) as they commonly co-occur. The study will be undertaken utilizing linked data within the Clinical Practice Research Datalink GOLD and Aurum databases with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. We will describe baseline characteristics in the two groups (including demographics, health behaviours (e.g. smoking), co-morbidities, treatment for COPD, and COPD severity) and compare all-cause mortality and cause specific mortality (cardiovascular) between the two groups using Cox proportional hazard models. We will also compare management and complications in the two groups including drug treatments and revascularisation procedures, major cardiovascular events and acute limb ischaemia.
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The Impact of COVID-19 on care for UK patients with chronic obstructive pulmonary disease (COPD) and patients with asthma — Afisi Ismaila ...
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The Impact of COVID-19 on care for UK patients with chronic obstructive pulmonary disease (COPD) and patients with asthma
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-17
Organisations:
Afisi Ismaila - Chief Investigator - GSK
Alexander Ford - Corresponding Applicant - Adelphi Real World
Eileen Han - Collaborator - GSK
Kieran Rothnie - Collaborator - GlaxoSmithKline - UK
Lucy Massey - Collaborator - Adelphi Real World
Qinggong Fu - Collaborator - GSK
Theo Tritton - Collaborator - Adelphi Real World
Tim Holbrook - Collaborator - Adelphi Real World
Outcomes: Change in inhaled corticosteroid dose (ICS) dose; Triple therapy use; Adherence to therapy (via proportion days covered [PDC]); Rate of COPD exacerbations; Rate of severe asthma exacerbations; FEV1% predicted (COPD cohort only); Lung function testing frequency; All-cause and COPD/asthma-related HCRU; All-cause and COPD/asthma-related direct medical costs; Rate of diagnosed COVID-19; COVID-19-related HCRU; COVID-19-related direct medical costs; All-cause/COVID-19-related mortality.
Description: Lay Summary
COVID-19 is a respiratory disease caused by infection with the virus SARS-CoV-2. The UK confirmed its first cases in January 2020 and as of the end of April 2021, had recorded more than 150,000 deaths where COVID-19 was listed on the death certificate. The widespread infection of SARS-CoV-2 in the UK has been considered an epidemic.
Technical Summary
Chronic obstructive pulmonary disease (COPD) and asthma are common conditions of the lungs. While COPD and asthma are each distinct conditions, patients with each of these conditions can experience shortness of breath, coughing and wheezing. The impact of COVID-19 is expected to be significant and possibly long lasting, especially among patients with COPD or asthma. During the UK epidemic, patients with severe asthma and severe COPD were considered âclinically extremely vulnerableâ and so were asked to reduce social contact to only essential contact (termed âshieldingâ) for periods of high coronavirus prevalence.
The COVID-19 epidemic in the UK may impact patients with COPD or asthma in two ways: either indirectly where patients with COPD or asthma receive worse healthcare due to the COVID-19 epidemic, or directly where patients with asthma or COPD are diagnosed with COVID-19. This study will assess both the indirect impacts and direct impact of the COVID-19 epidemic on patients in the UK with asthma or COPD by describing both the health of these patients and the healthcare provided to these patients during and in the years surrounding the UK epidemic.Aim: To assess the indirect and clinical impact of COVID-19 on patients with chronic obstructive pulmonary disease (COPD) and asthma in the years during and surrounding the UK COVID-19 epidemic, to inform and contextualize future research.
Objectives: For patients with asthma or COPD in the UK to describe over time: i) demographic and clinical characteristics; ii) changes in ICS dose, triple therapy use, and medication adherence; iii) factors relating to exacerbation frequency and lung function testing frequency and results; iv) all-cause, disease-related healthcare resource utilisation (HCRU) and direct medical costs; v) all-cause and COVID-19-specific mortality; vi) rate of SARS-CoV-2 infection; vii) hospitalization due to COVID-19.
Primary exposures: Treatment class, disease severity, ever diagnosed with COVID-19.
Outcomes: Change in ICS dose; Triple therapy use; Adherence; Disease-specific exacerbations; Lung function testing frequency and results; HCRU/ costs; Rate of COVID-19 diagnosis; COVID-19-related and all-cause HCRU/ costs; COVID-19-related/all-cause mortality.
Methods: A longitudinal retrospective dynamic cohort study using existing electronic primary and secondary care data of patients diagnosed with COPD or asthma. COPD and asthma cohorts will be analysed separately. The baseline period will be defined as the 12 months prior to the index date. After index, outcomes will be observed in monthly and yearly intervals until either the end of the study period, when the patients dies, or when data are no longer available.
Linked secondary care datasets will be used to describe HCRU and asthma/COPD exacerbations, and Office for National Statistics (ONS) data will be used to describe mortality.
Data Analysis: Counts, means, medians, standard deviation (SD), 25th and 75th percentile values will be reported for numeric variables, whilst relative frequencies and proportions/ percentages will be reported for nominal variables. HCRU and costs will be derived by observing consultations and medications in primary care, and Healthcare Resource Group for secondary care.
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Clinical outcomes from robotic colorectal surgery in England: a national study using routinely collected data — David Humes ...
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Clinical outcomes from robotic colorectal surgery in England: a national study using routinely collected data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
David Humes - Chief Investigator - University of Nottingham
Alastair Morton - Corresponding Applicant - University of Nottingham
Joe West - Collaborator - University of NottinghamOutcomes:
Primary outcomes: Number and proportion of robotic compared to laparoscopic or open colorectal cases undertaken per year and by region in England; 30 day and 90 day all cause mortality;
Secondary outcomes: length of stay, readmission rates, stoma formation and venous thromboembolism at 30 days in robotic compared to laparoscopic colorectal surgery.Description: Technical Summary
Background: Robotically-assisted colorectal surgery has expanded in the last decade since first reported in 2002. Previous Randomised-Controlled Trials and Systematic Reviews have demonstrated equivalent oncological outcomes, compared to laparoscopic surgery, with possibly decreased length of stay and conversion to open surgery. However, these studies were based solely off data from the United States, with no data from England. No studies have been done in England comparing the outcomes of patients undergoing robotically-assisted versus laparoscopic surgery.
Objectives:
⢠To quantify the uptake of robotic colorectal surgery by year and geographical region in England.
⢠To compare 30 and 90 day mortality, length of stay, readmission rates, stoma formation and venous thromboembolism (VTE) in robotic versus laparoscopic colorectal surgery in EnglandDesign: This will be a retrospective historical cohort study of patients undergoing elective colorectal surgery from 2002 to 2020. Patients will be identified using the relevant Office of Population Censuses and Surveys codes for colectomy from HES data for this period. Geographical region, socio-economic status and year will be defined from HES data. 30/90 day mortality will be defined from the Office of National Statistics data, with length of stay, readmission, stoma formation and VTE rates from linked HES and CPRD Aurum data.
Means will be used for parametric data, medians for non-parametric data and percentages for categorical variables. Analysis will be done with relevant parametric or non-parametric tests, for example the Mann-Whitney U test for length of stay, assuming non-parametric distribution. VTE rates will be analysed by Cox regression, adjusted for confounders. Crude mortality rates will be calculated and compared using Cox regression analysis.
Outcomes: If we demonstrate that robotic surgery has equivalent or superior outcomes to laparoscopic surgery in England, this would help adoption of this approach. By highlighting regional differences, we hope to minimise future variations in access.
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Clinical and economic burden of illness of catheter users in the UK — Audrey Artignan ...
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Clinical and economic burden of illness of catheter users in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Audrey Artignan - Chief Investigator - Costello Medical Consulting Ltd
Audrey Artignan - Corresponding Applicant - Costello Medical Consulting Ltd
Amy Buchanan-Hughes - Collaborator - Costello Medical Inc.
Fiona Mthombeni - Collaborator - Coloplast
Gareth Jones - Collaborator - Central Manchester University Hospitals
Harriet Cant - Collaborator - Costello Medical Consulting Ltd
Iro Chatzidaki - Collaborator - Costello Medical Consulting Ltd
Jalesh Panicker - Collaborator - National Hospital for Neurology and Neurosurgery
Jennifer Page - Collaborator - Costello Medical Consulting Ltd
Jonathan Pearson-Stuttard - Collaborator - Imperial College London
Marie Lynge Buchter - Collaborator - Coloplast
Rachel Ainsworth - Collaborator - Coloplast
Tatjana Marks - Collaborator - Costello Medical Consulting LtdOutcomes:
Outcomes to be measured
Primary OutcomesProduct Use
⢠Type of catheter used (indwelling vs intermittent); cost associated with catheter use; number of catheters used per day; type of other continence product used; total cost associated with other continence product use; number of other continence products used per day
Prevalence and Incidence of Comorbidities
⢠Overall prevalence of comorbidity events; prevalence of specific comorbidities (diabetes; dehydration; mental health disorders; sexual dysfunction; overall UTIs; upper UTI; lower UTI; UTI, site not specified; infection in the prostate or testicles; pyelonephritis; all sepsis; possible uro-sepsis; kidney disease; calculus of urinary tract; urinary obstruction and urinary strictures; cancer in bladder or urethra; bowel disease; urinary incontinence; retention; resistance to antibiotics; autonomic dysreflexia; haematuria; mechanical complication of urinary [indwelling] catheter; infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system)
⢠Overall incidence of comorbidity events; incidence of specific comorbidities (dehydration; mental health disorders; overall UTIs; upper UTI, lower UTI; UTI, site not specified; infection in the prostate or testicles; pyelonephritis; all sepsis; possible uro-sepsis; calculus of urinary tract; resistance to antibiotics; autonomic dysreflexia; haematuria; mechanical complication of urinary [indwelling] catheter; infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system)Costs and Resource Use Associated with Comorbidities
⢠GP visits for UTIs; admissions for UTIs (as a primary diagnosis); admissions with UTIs (as a secondary diagnosis); non-elective admission for UTIs; elective admissions for UTIs; readmissions for UTIs and dehydration
⢠Length of stay for comorbidities (dehydration; UTIs; all sepsis; possible uro-sepsis; kidney disease; resistance to antibiotics)
⢠Overall cost associated with comorbidities; cost associated with specific comorbidities (dehydration; overall UTIs; upper UTI; lower UTI; UTI, site not specified; infection in the prostate or testicles; pyelonephritis; all sepsis; possible uro-sepsis; kidney disease; autonomic dysreflexia)Medication Use
⢠Prevalence of use of the following medications: antibiotics; antibiotic use possibly used to treat a UTI; medication for mental health; medication urinary frequency and incontinence; laxative and other bowel-related medication; MS-related medication; pain killers; prophylactic antibiotics
⢠Incidence use of the following medications: antibiotics; antibiotics possibly used to treat a UTI; pain killers
⢠Costs associated with antibiotic use; costs associated with antibiotics possibly used to treat a UTIOverall Healthcare Utilisation
Total cost; total health care utilisation; average length of stay when hospitalised; average number of hospitalisations; average number of emergency visits; average number of GP visits; average cost of hospitalisation; average cost of emergency visit; average cost of GP visit; average outpatient medication costs; hospital death rate
Top Ranked Reason for Healthcare Utilisation
Top 20 reasons for hospital admissions; emergency room visits; readmissions GP visits; specialist consultant (urologist) visits; top 20 primary diagnoses of patients who died in hospital
Secondary Outcomes
Age; gender; ethnicity; patient-level and practice-level deprivation score
Description: Technical Summary
The aim of this study is to characterise the clinical and economic burden associated with chronic intermittent catheterisation, as well as the burden experienced by patients using different bladder management solutions amongst key clinical subgroups (patients with multiple sclerosis [MS] and with spinal cord injury [SCI]). The study will be carried out using a retrospective cohort design and use data from the 1st of January 2011 to the 31st of December 2020. Data on patient care records will be taken from the CPRD; secondary care data relevant to catheter use will be taken from the Hospital Episode Statistics database for patients in England. In the primary analysis, chronic intermittent urinary catheter users, defined as patients with â¥3 records of a relevant product code, with consecutive relevant records recorded within â¤4 months of each other, and who have been using catheters â¥6 months, will be compared to a cohort of non-catheterising patients matched 1:5 on age and gender. Start of follow-up will be the date of index intermittent catheterisation; patients will be followed until an interruption of catheter use or censoring from the dataset (end of CPRD follow-up or death). The secondary analyses will compare users of different bladder management solution (intermittent catheters, indwelling catheters, no catheters) amongst patients with MS or SCI, and non-catheterising patients from the general CPRD population matched 1:5 on age and sex. The demographic characteristics of the exposed and unexposed cohorts included in the primary and each of the secondary analyses will be summarised. Outcomes include clinical conditions and the costs associated with relevant healthcare utilisation and medication use. For statistical testing between groups, the Chi-squared or Mann-Whitney Wilcox tests will be used for categorical and continuous variables, respectively, with an alpha of 0.05.
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Assessing the clinical and economic burden among patients with Clostridium Difficile Infection and recurrent Clostridium Difficile Infections: A real-world evidence study — Sarah Jenner ...
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Assessing the clinical and economic burden among patients with Clostridium Difficile Infection and recurrent Clostridium Difficile Infections: A real-world evidence study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-11
Organisations:
Sarah Jenner - Chief Investigator - IQVIA Ltd
Emily Wilkes - Corresponding Applicant - IQVIA Ltd
Margherita Bortolini - Collaborator - IQVIA Ltd
Peter Egger - Collaborator - IQVIA Ltd
Sarah Lay-Flurrie - Collaborator - IQVIA LtdOutcomes:
Incidence of CDI including rCDI; Complications of CDI; All-cause Mortality; HCRU and associated costs
Description: Technical Summary
This is a retrospective cohort study including adult patients diagnosed with CDI between 1st January 2015 and 31st December 2019, with first CDI diagnosis as index date. The index CDI diagnosis must not be preceded by another CDI episode within the previous 8 weeks.
Four cohorts will be created according to index CDI setting, identified using CPRD-HES linked data, (healthcare or community-acquired) and treatment (hospital-treated or community-treated).Person characteristics (age, gender) and medical history (procedures, treatments, comorbidities) will be evaluated 12 months preceding index date and patient outcomes will be assessed over the follow-up period of up to 24 months after index date.
CDI episodes post index that occur within 8 weeks of a previous episode are defined as recurrent episodes (rCDI).
Study outcomes include index and recurrent CDI episodes, CDI complications, all-cause and excess mortality and HCRU.Annual incidence rates of CDI and recurrence will be reported.
Time between CDI episodes will be described using non-parametric Kaplan-Meier analyses.
Incidence of CDI complications up to 12 months post-index will be analysed using adjusted Cox regression analyses. Crude all-cause mortality rate of CDI patients will be estimated up to 24 months post index.
Excess mortality will be assessed by matching CDI patients 1:5 to non-CDI patients and estimating the difference in incidence death rates.
âStandard of careâ Sankey diagrams of patientsâ treatment pathway from index to end of follow-up will be presented.HCRU up to 12 months post-index per patient and per incremental CDI episode will be reported alongside associated costs.
A matched cohort design will be used to estimate difference in cumulative HCRU costs due to CDI for CDI, recurrent CDI and non-CDI patients up to 12 months post index.Analysis will be stratified by various covariates (e.g. age, gender, number of recurrence) as specified per study objective.
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Concomitant use of biphasic insulin aspart and glucagon-like peptide-1 receptor agonist compared to modern basal insulin combined with glucagon-like peptide-1 receptor agonist: effect on glycaemic control in type 2 diabetes patients — Uffe Christian Braae ...
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Concomitant use of biphasic insulin aspart and glucagon-like peptide-1 receptor agonist compared to modern basal insulin combined with glucagon-like peptide-1 receptor agonist: effect on glycaemic control in type 2 diabetes patients
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-05
Organisations:
Uffe Christian Braae - Chief Investigator - Novo Nordisk
Uffe Christian Braae - Corresponding Applicant - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Anders Boeck Jensen - Collaborator - Novo Nordisk
Gayathri Anil - Collaborator - Novo Nordisk
Melanie Davies - Collaborator - University of Leicester
Rikke Baastrup Nordsborg - Collaborator - Novo NordiskOutcomes:
Glycaemic control; weight/BMI; hypoglycaemia
Description: Technical Summary
This study aims to compare the effect on glycaemic control of first time combined use of BIAsp 30 and GLP-1 with first time combined use of modern basal insulin and GLP-1 in T2DM patients living in England. Furthermore, we will investigate the change in weight and the rate of hypoglycaemia after treatment initiation. BIAsp 30 is effective in controlling glycaemic levels in T2DM patients, however, limited evidence is available describing the relative effect when combined with GLP-1 compared to modern basal insulin and GLP-1 treatment in a real-world setting. The study will use a retrospective cohort design, with the first time combined treatment of insulin and GLP-1 date as index, to compare effect on glycaemic control based on HbA1c concentrations prior to index and during a 12-month post-index follow-up period. Propensity score matching will be used to match patients between treatment arms. Mixed model of repeated measures (MMRM) will be used to evaluate mean HbA1c levels from baseline to end of follow-up and change in HbA1c from index to 26 weeks post index. Identical methodology will be used to examine change in mean BMI. The risk of hypoglycaemia will be evaluated by comparing the rate of hypoglycaemia prior to index with the rate of hypoglycaemia during follow-up using a negative binomial regression model with a log-transformed follow-up time offset term. The study will provide knowledge on the effect of combined treatment of BIAsp 30 and GLP-1 on glycaemic control relative to basal insulin in combination with GLP-1 treatment in a real-world setting.
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Respiratory infection related cardiovascular disease: a prognostic modelling and causal inference study — Joseph Lee ...
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Respiratory infection related cardiovascular disease: a prognostic modelling and causal inference study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-09
Organisations:
Joseph Lee - Chief Investigator - University of Oxford
Joseph Lee - Corresponding Applicant - University of Oxford
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Constantinos Koshiaris - Collaborator - University of Oxford
James Sheppard - Collaborator - University of Oxford
Jennifer Davidson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Richard Hobbs - Collaborator - University of OxfordOutcomes:
Primary outcome: Cardiovascular disease events
Secondary outcomes: Coronary events; Cerebrovascular events; bleeding; major bleeding
Description: Technical Summary
Aim âto investigate if aspirin and influenza vaccine, currently used for secondary prevention of cardiovascular disease (CVD), could be used as primary prevention for people at risk of infection-related CVD.
Population: adults over 40 years of age without prior CVD
Exposures: Respiratory infection, Aspirin, Influenza vaccine
Outcomes: Primary: CVD. Secondary: subtypes of CVD; bleeding/major bleedingObjectives:
1. Derive a risk prediction model for infection-related CVD in CPRD Aurum.
2. Validate this prediction model in CPRD Gold.
For high-risk patients as identified by the model:
3. Examine the effects of aspirin on infection-related CVD.
4. Examine the effects of Influenza vaccine on infection-related CVD.Methods:
1&2) We will use logistic regression to predict CVD in the 28 days following a first respiratory infection in CPRD Aurum and externally validate in Gold (using C statistics, E/O ratios, calibration plots).3) To estimate the effect of aspirin on CVD, bleeding, and major bleeding in the 28 days following respiratory infection we will use logistic regression, instrumental variable (prescriber history, using ordinary least squares regression) and propensity score analyses (propensity modelled by mixed effects logistic regression). Sensitivity analyses are - timing of aspirin prescriptions, other antiplatelets (combined) and anticoagulants. Further analyses will examine instrument validity, magnitude and direction of bias.
4) We will examine the effect of influenza vaccine on CVD using Cox proportional hazards regression in a matched cohort. We will match vaccinated people to unvaccinated controls on age, sex, practice, date and indication for vaccination and follow them up for 180 days, until events, or the matched control is vaccinated. We will consider matching effective if there is no difference in infections between groups in the first 14 days, before vaccine protection starts. We will also use vaccine effectiveness for infection as an instrument.
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Evaluating treatment patterns of venous thromboembolism patients in primary care — Steven Lister ...
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Evaluating treatment patterns of venous thromboembolism patients in primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Steven Lister - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Carroll - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Kevin Pollock - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Lianne More - Collaborator - Pfizer Ltd - UK
Raza Alikhan - Collaborator - University Hospital of WalesOutcomes:
Primary Outcomes:
⢠Number and proportion of VTE patients receiving each treatment: apixaban, rivaroxaban, dabigatran, edoxaban and warfarin during the inclusion period (2013-2019), for the overall cohort of VTE patients, by calendar year and by VTE sub-groups (PE or DVT).Secondary Outcomes:
Description of patient demographic and clinical characteristics according to:
⢠The cohort: for overall VTE cohort and by VTE sub-groups (PE, DVT) for the overall inclusion period
⢠Each treatment: apixaban, rivaroxaban, dabigatran, edoxaban and warfarin
- For the overall VTE cohort
- For each VTE sub-group (PE, and DVT)
⢠By calendar year for the inclusion period
- For the overall VTE cohort
- For each VTE sub-group (PE, and DVT)Description: Technical Summary
Deep vein thrombosis (DVT) and pulmonary embolism (PE), collectively known as venous thromboembolism (VTE), comprise the third most frequent acute cardiovascular syndrome after myocardial infarction and stroke globally. Anticoagulation therapy is the mainstay of treatment for VTE patients. The use of oral vitamin K antagonists (VKAs), including warfarin, has historically been the commonest approach to anticoagulation treatment in VTE patients without cancer, but it is associated with several practical challenges, including numerous food and medication interactions, and the need for regular anticoagulation monitoring. The non-VKA oral anticoagulants (NOACs) have emerged as viable alternatives to VKA therapy in patients with VTE. Prospective, randomized clinical trials and real-world studies comparing NOACs to VKAs demonstrate comparable efficacy and the potential for improved safety, in terms of reductions in major bleeding such as intracranial haemorrhage (ICH). Up-to-date data to demonstrate how VKA or NOACs are currently being used to treat patients with VTE in routine clinical practice is, however, limited. The aim of the current study is to generate contemporary data describing trends over time in the use of oral anticoagulants. A retrospective cohort study using CPRD will be conducted to describe the treatment patterns and patient characteristics in VTE patients. The population of interest will include all incident VTE patients diagnosed between 1 January 2013 to 31 December 2019. The primary outcome of interest will be the frequency and type of oral anticoagulation prescribed following an incident VTE diagnosis. The study will be descriptive and therefore there is no primary exposure/comparator group. This study will generate evidence on changes in the use of oral anticoagulation over time, providing clinicians, patients and policy makers a population level view of current trends in VTE patient management, and facilitate comparison of these trends with established clinical guidelines.
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Evaluating the performance of cutting-edge statistical methods in reducing confounding bias using plasmode simulations of electronic health record data — Virginie SIMON ...
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Evaluating the performance of cutting-edge statistical methods in reducing confounding bias using plasmode simulations of electronic health record data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-08-26
Organisations:
Virginie SIMON - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Virginie SIMON - Corresponding Applicant - IRIS - Institut de Recherches Internationales Servier
Adrien Billaud - Collaborator - IRIS - Institut de Recherches Internationales Servier
Gauvain Youdom - Collaborator - IRIS - Institut de Recherches Internationales Servier
Jade Vadel - Collaborator - IQVIA Operations France SASOutcomes:
Being a methodological study, the focus will be on only one outcome â the time to blood pressure control â that was the primary outcome of the previous study ISAC n°16_166R [5. Marinier 2019] .
Description: Technical Summary
Propensity score is the probability of receiving a given treatment based on various baseline characteristics. This method is widely recommended to handle confounding bias in comparative research [1. Austin 2011 ]. Logistic regression is almost exclusively used to estimate propensity score, and the baseline characteristics are generally simply selected by clinician. Although it may prove accurate in many cases, residual bias may arise from these naïve modelling choices, and alternative methods may be more accurate.
High-Dimensional propensity score (hdPS) is an algorithm that automatically selects the covariates to be included in the propensity score model based on their potential for confounding â provided by Brossâ formula [2. Schneeweiss 2009 ]. This method is advocated as a powerful way to select the right baseline covariates for eradicating confounding bias.
Neural Networks, Support Vector Machines (SVM), decision trees (CART), and meta-classifiers are alternatives to logistic regression in estimating propensity scores, with fewer assumptions and supposedly at least as great accuracy [3. Westreich 2010 ].
Targeted Maximum Likelihood Estimation (TMLE) is a general algorithm for the construction of double-robust, semiparametric, efficient substitution estimators based on the targeted minimum loss-based estimation and machine learning algorithms to minimise the risk of model misspecification [4. Van der Laan 2011 ].
To evaluate all these methods, we will replicate a previous study (ISAC protocol n°16_166R) whose main objective was to assess the effectiveness of initiating therapy with one or two drug classes in hypertension disease management [5. Marinier 2019]. New users initiating bi-therapy will be matched (1:2) to those initiating monotherapy using propensity scores built with above methods and the outcome of time to blood pressure control will be analysed with a Cox proportional hazards model â except for TMLE that directly estimates the hazard ratio in a non-parametric model on the entire patient set.
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Extension: Treatment Resistant Depression Study
— Imperial College Health Partners...
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Extension: Treatment Resistant Depression Study
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Depression. Commercial
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Extension: Borough Public Health Profiles and JSNA information
— Westminster City Council...
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Extension: Borough Public Health Profiles and JSNA information
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-21
Opt Outs: no information provided./p>
Organisations: Westminster City Council
Description: Kensington and Chelsea and Westminster.
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Extension: Utilisation of real-world evidence in profiling the efficacy and safety for Ustekinumab (Stelara) in treating IBD patients in North West London
— Imperial college Health Partners...
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Extension: Utilisation of real-world evidence in profiling the efficacy and safety for Ustekinumab (Stelara) in treating IBD patients in North West London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Aug-21
Opt Outs: no information provided./p>
Organisations: Imperial college Health Partners
Description: Inflammatory Bowel Disease. Commercial
Source
2021 - 07
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Shielded Patient List & Covid Risk Extract (Identifiable) (Direct Care) — NHS England...
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To enable the matching of severely immunosuppressed individuals with vaccine event records and monitoring of the take up of the 3rd dose of the vaccine . — IG-04309
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 10/07/2021
Purpose for which the data is being used: To enable the matching of severely immunosuppressed individuals with vaccine event records and monitoring of the take up of the 3rd dose of the vaccine .
Dataset: Shielded Patient List & Covid Risk Extract
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice and Health and Social Care Act 2012 section 261(2)(b)(ii)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) - substantial public interest plus DPA 2018 Part 2 Schedule 1 para 6 - Statutory and governmental purpose GDPR Article 9(2)(h) - healthcare purposes, plus DPA 2018 Part 1 Schedule 1 para 2 - health or social care purpose GDPR Article 9(2)(i) - public health purposes, plus DPA 2018 Part 1 Schedule 1 para 3 - public health
Statutory Authority: COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) - substantial public interest plus DPA 2018 Part 2 Schedule 1 para 6 - Statutory and governmental purpose GDPR Article 9(2)(h) - healthcare purposes, plus DPA 2018 Part 1 Schedule 1 para 2 - health or social care purpose GDPR Article 9(2)(i) - public health purposes, plus DPA 2018 Part 1 Schedule 1 para 3 - public health
National Data Opt-out Applied: Not Applied - Direct Care and legal obligation overrides.
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The prevalence and healthcare utilization of rescue medication users for seizure emergency management in the UK community: a CPRD retrospective database study — Yuanjun Ma ...
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The prevalence and healthcare utilization of rescue medication users for seizure emergency management in the UK community: a CPRD retrospective database study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-04
Organisations:
Yuanjun Ma - Chief Investigator - UCB Biopharma SRL - Belgium Headquarters
Yuanjun Ma - Corresponding Applicant - UCB Biopharma SRL - Belgium Headquarters
Ana Bartmann - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Chao Lu - Collaborator - UCB BioSciences, Inc.
Florian Hummel - Collaborator - UCB Pharma GmbH
Guilhem Pietri - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Nadia Foskett - Collaborator - UCB BioSciences, Inc.
Rita Campos - Collaborator - UCB Inc
Simon Borghs - Collaborator - UCB Pharma SA - UK
Uffe Ploug - Collaborator - UCB Biopharma SRL - Belgium HeadquartersOutcomes:
The following outcome variable will be analyzed in the study: Prevalence of patients prescribed RMs; Proportions of patients with newly prescribed RMs; Demographics (age at index, gender, region of residence); Clinical characteristics (SE, AED treatment, epilepsy type, comorbidities); Post index healthcare resource utilization (in patient hospitalization, outpatient visit, Accident & Emergency attendances), and death.
Description: Technical Summary
Patients with epilepsy at known increased risk of status epilepticus (SE) may be prescribed rescue medications to manage epilepsy emergency. Available rescue medications (RMs) used to manage the prolonged/repeated in the UK community (outside of the hospital setting) from 2016 are buccal midazolam (MDZ), rectal diazepam (DZP), oral lorazepam, oral DZP, oral clobazam, oral clonazepam, and rectal paraldehyde. However, there are still unmet medical need in the community and patients may develop to SE. To find solutions to address unmet medical need, a better understanding is required with regard to the current unmet needs in the treatment of prolonged seizures and use of the authorized and off-label RMs in the market. The objective of this study is to provide insights on the emergency medical treatments for prolonged or repeated seizures in the UK community (outside of hospital setting), by evaluating the prevalence of patients prescribed RMs, describing demographic and clinical characteristics, and HCRU. This will be a retrospective cohort study of patients prescribed RMs in the UK community using general practice data recorded in CPRD linked to hospital records in Hospital Episodes Statistics (HES) and the Office for National Statistics (ONS). Patients are eligible for this study if they had at least one recorded rescue medicine prescription in CPRD from year 2016 through the last data collection date in CPRD. Data for prevalence, demographic and clinical characteristics, and HCRU analysis will be described using descriptive statistics where continuous variables will be summarized using mean/median and categorical variables will be summarized as frequency or percentage. The analysis will be done for the overall population and stratified by RM types and age groups. Knowledge from this study will inform science of the demographics and clinical experience of patients prescribed RMs and will add to the paucity of the available data.
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Evaluation of the real-world safety of angiotensin-converting enzyme inhibitors on the risk of lung cancer — Elizabeth Williamson ...
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Evaluation of the real-world safety of angiotensin-converting enzyme inhibitors on the risk of lung cancer
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-11
Organisations:
Elizabeth Williamson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Corentin Ségalas - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
David Turner - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
James Carpenter - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Paris Baptiste - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
We are interested in evaluating the association between prescription of ACEI and risk of lung cancer.
Primary outcome: incident lung cancer (diagnosis or death with lung cancer listed as a cause if no prior diagnosis)
Secondary outcomes (negative control outcomes):
- Lung related: chronic obstructive pulmonary disease (COPD); sarcoidosis; asbestosis
- Not lung related: fracture (any); herpes zoster; incident colon cancerIt is likely that the primary question of interest will be heavily confounded, in particular by inadequate adjustment for smoking, thus a number of negative and positive controls will be used to help identify residual confounding. For the lung-related negative controls, we expect these to be strongly associated with smoking status but there is less clear rationale for believing a causal effect of ACEI prescription exists (particularly asbestosis). Thus, apparent treatment effects would suggest inadequate adjustment for smoking. Fracture is included as a general marker of frailty; colon cancer is unlikely to be affected by ACEI prescription but smoking and other lifestyle factors are risk factors, again allowing us to pick up signals of residual confounding by these characteristics.
Description: Technical Summary
A recent population-based cohort study by Hicks et al. (2018) using CPRD data has found an association between ACEI prescription and the risk of lung cancer. However, confounding bias is a major problem when estimating the association between drug prescription and the outcome of interest. We propose a number of analyses to explore, quantify and where possible, remove, that bias:
(i) Applying standard PS analyses and High-Dimensional Propensity Score (HDPS) or modified versions, as described below, to account for confounding
(ii) Negative controls outcomes
(iii) Sensitivity analyses to explore confounding by smoking and detection bias (âtreatmentâ effects mediated through early diagnosis due to ACEI effects on cough).To achieve this, a subsidiary goal is to assess the optimal statistical methodology for conducting propensity score analyses in EHR using high-dimensional confounder adjustment. While the HDPS is gaining in popularity, a number of other approaches exist and may perform better in certain settings.
The HDPS consists of four steps: (1) creating a set of candidate confounder variables from patient codes, (2) selecting relevant confounder variables from this pool, (3) fitting a model relating the drug prescription to the selected confounder variables to estimate the PS, (4) estimating the treatment effect using the PS. We will evaluate different statistical methods for achieving the second and third steps and comparing them both in these data and in a plasmode simulation study based on these data (Franklin et al. 2014). For the second step, approaches based on the least absolute shrinkage and selection operator (lasso) and the elastic net (Franklin et al. 2015) and others based on dimensionality reduction (Schneeweiss et al. 2017) exist. For the third step, techniques proposed in the literature include neural networks, generalized boosting, ridge regression, random forest, CART (Franklin et al. 2015, Schneeweiss et al. 2018, Karim et al. 2018).
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Determining treatment pathways, healthcare resource usage, and associated costs of patients with Myasthenia Gravis in England — Jay Were ...
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Determining treatment pathways, healthcare resource usage, and associated costs of patients with Myasthenia Gravis in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-29
Organisations:
Jay Were - Chief Investigator - Health iQ
Shea O'Connell - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Boglarka Kovacs - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQ
Mico Hamlyn - Collaborator - Health iQ
Seth Jarvis - Collaborator - Health iQOutcomes:
Total number of MG patients; Demographics (Mean and median age on inclusion, age distribution by decade, sex distribution, deprivation, Charlson co-morbidity score distribution, mean and median follow-up, total and mean admitted time, smoking status, index of multiple deprivation quintile distribution); presence of co-morbidities prior to inclusion (diabetes, coronary artery disease, ischaemic heart disease, hypertension, stroke, hypoparathyroidism, asthma, COPD, rheumatoid arthritis, systemic lupus erythematosus, osteoporosis); admissions to critical care unit per patient per year of follow-up; treatments and therapies per patient, and line of therapy recorded at (steroids, immunotherapy , intravenous immunoglobulin, rituximab, plasmapheresis or plasma exchange, thymectomy); time on treatment in days (where applicable); number of patients and number of prescriptions recorded in primary care for immunotherapy products; healthcare resource outcomes (prescriptions issued in primary care, GP appointments in primary care, number of inpatient admissions, inpatient length of stay, inpatient HRG tariffs, number of outpatient appointments, outpatient HRG tariffs, number of A&E attendance, A&E HRG tariffs );
Description: Technical Summary
Current clinical standards of care for MG include acetylcholinesterase inhibitors, steroids, immunosuppressants and, in the case of hospitalisation for myasthenic crisis, intravenous immunoglobulin (IVIG) and plasmapheresis [1â4]. Many patients treated with these continue to experience symptoms and these medications can increase susceptibility to serious infections. There is a significant unmet need for therapies with sustained clinical benefit and a need for understanding how MG-related healthcare resource usage (HCRU) compares to patients without MG throughout the full clinical pathway, outside of crisis.
Whilst MG patients with myasthenic crisis are known to have high HCRU, it is currently unknown what the drivers of HCRU are along the MG treatment pathway or how that HCRU compares to matched controls. In order to inform healthcare policy where efficiencies can be made in treating and managing MG, there is a need to describe the current treatment pathway for patients diagnosed with MG, and to quantify their HCRU and associated costs.
This study aims to form a cohort of MG patients, included using diagnosis codes from primary and secondary care, stratified into sub-cohorts according to their peak non-crisis annualised HCRU. We shall describe demographic and clinical characteristics of MG patients, describe their HCRU, and sequence lines of therapy. Outcomes will be described as total, means, medians, percentage or rates as appropriate. HCRU and associated costs for MG patients across primary and secondary care will be compared to a matched control cohort of patients without MG using generalised linear models and estimated marginal means, where appropriate. Cohort formation will use both the CPRD-Aurum dataset linked to HES, with death data linked via the ONS Death Registry. CPRD-HES-ONS linkage allows for a description of clinical outcomes, and HCRU and associated costs across both primary and secondary care, ensuring the full clinical pathway of patients is accurately described.
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The effect of increasing physician workload on the choice of referrals to secondary care units and lab tests — Toby Watt ...
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The effect of increasing physician workload on the choice of referrals to secondary care units and lab tests
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-06
Organisations:
Toby Watt - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Hanifa Pilvar - Collaborator - Queen Mary University of LondonOutcomes:
GP daily workload, nurse daily workload, practice average workload, referral probability by the urgency of referral (2 week wait, urgent, soon, routine, dated), referral to test laboratories.
Description: Technical Summary
The aim is to use CPRD to identify a measure of workload and then identify the effect of workload on the health outcomes; namely, the probability of referral. We focus on London to minimise the confounding effect of geographical differences in the access to health care and underlying health conditions among patients. We will look at cross-sectional variation of workload across practices and within each practice.
Our research will consist of the following steps:1. Constructing a measure for daily workload at practice level. This is the average patient consultation to GP ratio.
2. Identifying the fluctuations of the daily workload during the year within a practice.
3. We use the unexpected fluctuations in the workload pressure through unexpected absence of a GP to identify an exogeneous and random variation in the workload pressure. Absence is measured if the doctor was working in the practice in a 2-week window period but has zero consultation in a given day
4. Then we will examine whether there is any association between this exogeneous variation in the workload and the choice of diagnostic inputs. We will focus on a linear probability regression for the referral to specialist, but we will also include referral to test labs.
5. The analysis will be expanded to explain how the workload of other staffs, namely practice nurses varies and how it helps reducing the workload of GPs.The analysis will be done using 2 stage least square analysis for two years.
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Estimating national and local prevalence of mental health conditions during perinatal period in England: an exploratory study — Gabriele Price ...
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Estimating national and local prevalence of mental health conditions during perinatal period in England: an exploratory study
Datasets:GP data, Practice Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-04
Organisations:
Gabriele Price - Chief Investigator - Office for Health Improvement and Disparities
Gabriele Price - Corresponding Applicant - Office for Health Improvement and Disparities
Arvinder Duggal - Collaborator - Office for Health Improvement and Disparities
Cam Lugton - Collaborator - Office for Health Improvement and Disparities
Danny Yip - Collaborator - Office for Health Improvement and Disparities
Holly Hope - Collaborator - University of Manchester
Kathryn Abel - Collaborator - University of Manchester
Louis Thackray - Collaborator - Office for Health Improvement and Disparities
Louise Howard - Collaborator - King's College London (KCL)
Matthew Wickenden - Collaborator - NHS England
Sarah Dunsdon - Collaborator - NHS EnglandOutcomes:
Primary outcomes: national prevalence of mental health conditions in perinatal period; national prevalence of mental health condition sub-groups in perinatal period; national prevalence of mental health condition in perinatal period by age groups/ ethnicity groups/ deprivation quintiles; local prevalence of mental health conditions in perinatal period
Secondary outcomes: national prevalence of mental health conditions in perinatal period by combination of deprivation quintiles, age groups and ethnicity groups for local estimates purpose.
Amendments â 24 September 2021
The following amendments are requested (including justification for request)
Amended 2 â report prevalence at 1-year follow up post birth
This study aligns the main period prevalence outcome with NHS Long Term Plan - up to 2 years post birth for women experiencing mental health problems during and after pregnancy. Expert reference group advise was that comparison of period prevalence between up to 2 years post birth and up to 1 year (as (secondary outcome measure) would be of value to understand the impact of this change. However, study main findings and local prevalence estimates (primary outcome measures) will be reported based on up to 2 years post birth follow up.
Amendment 3 â addition of region as analytical variable and outcome measure
Evidence suggest* that regional differences in the prevalence of maternal and perinatal mental illness exists with highest prevalence in regions with the most deprivation. Initial analysis from this study shows that regional differences in the prevalence estimates are also present and expert advice was that region is included as:
⢠Primary outcome measure â regional prevalence of mental health conditions in perinatal period
⢠In the modelling approach of local prevalence estimates* Abel KM, Hope H, Swift E, Parisi R, Ashcroft DM, Kosidou K, et al. Prevalence of maternal mental illness among children and adolescents in the UK between 2005 and 2017: a national retrospective cohort analysis. The Lancet Public Health. 2019;4(6):e291-e300. (https://doi.org/10.1016/S2468-2667(19)30059-3)
Description: Technical Summary
Pregnancy is an important event in the life-course of a women that can have significant impact on the mental health needs of the individual. Existing evidence base has shown the absence of a reliable estimation of perinatal mental health prevalence across England, or how this prevalence may vary across the types of mental health conditions. There is a need to produce more informed estimates of prevalence surrounding perinatal mental health to help us understand mental health needs of women during this period. The purpose of this study is to estimate the prevalence of perinatal mental health conditions in women aged 15 to 55 years in England and at the local population level. The study is exploratory, by determining women with evidence of birth event in the CPRD using a validated algorithm combining live births, still births, and premature births codes indicative for a birth event. Historic medical data 1 year preceding and 2 years following the birth event will be included. A wide range of new and pre-existing mental health conditions will be examined based on diagnosis, and combination of symptoms and/or medication. The main outcome variables are counts and proportion of women with a mental health condition including demographic and socio-economic data. Descriptive analysis will be used to present overall prevalence of perinatal mental health conditions, and variation in prevalence by conditions sub-groups and women characteristics. Adjusted multi-variable logistic regression will be used to assess variables that are significant predictors of mental health conditions prevalence in perinatal period. Synthetic estimation approach will be used to calculate local prevalence estimates. This study will generate evidence about the prevalence of perinatal mental health of women who gave birth based on recent primary care data, representative for the England population.
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An evaluation of the prevalence, epidemiology and burden of illness of bone and joint infections in the United Kingdom: a retrospective observational cohort study — Cerys Jenkins ...
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An evaluation of the prevalence, epidemiology and burden of illness of bone and joint infections in the United Kingdom: a retrospective observational cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-08
Organisations:
Cerys Jenkins - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Elgan Mathias - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Andrew Cooper - Collaborator - Shionogi BV
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Harry Fisher - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Lopes - Collaborator - Shionogi BV
Stefano Verardi - Collaborator - Shionogi BV
Stephen Marcella - Collaborator - Shionogi IncOutcomes:
Prevalence and incidence of osteomyelitis and joint infections; NHS resource use associated with osteomyelitis and joint infections; NHS resource use associated with Gram-negative and Gram positive osteomyelitis and joint infections.
Description: Technical Summary
We aim to estimate the prevalence and incidence of bone infection (osteomyelitis) and joint infection (such as septic arthritis) in a UK population based on CPRD and to characterise their epidemiology in terms of healthcare resource use. Our special interest is in the type of pathogen responsible for the infection where recorded, with the aim of informing future treatments.
Acceptable patients eligible for linkage to HES data and having an ICD-10 code indicative of osteomyelitis or direct infection of a joint will be selected. NHS resource use (primary care consultations, prescriptions, outpatient appointments and inpatient admissions) and associated costs will be characterised. Prior comorbidities will be determined in Aurum using prodcode and medcode classifications.
Period prevalence will be calculated for 2019, based on patients registered at 31st December 2018. We will also calculate the incidence of osteomyelitis and joint infections in 2019. Frequency of healthcare use, as primary-care contacts, inpatient episodes, outpatient attendances, prescriptions issued in primary care, and frequency and type of surgical procedures (via OPCS codes) will be calculated for 2019. Clinical manifestations will be determined in HES from ICD-10 and OPCS codes. Linked HES admitted patient care data will aid the selection of cases and enable analysis of inpatient resource use; HES outpatient data and will enable analysis of outpatient resource use. HES A&E data will enable analysis of resource use.
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Trends in primary care prescribing of benzodiazepines, antipsychotics and beta-blockers for anxiety. — Charlotte Archer ...
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Trends in primary care prescribing of benzodiazepines, antipsychotics and beta-blockers for anxiety.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-08
Organisations:
Charlotte Archer - Chief Investigator - University of Bristol
Charlotte Archer - Corresponding Applicant - University of Bristol
David Kessler - Collaborator - University of Bristol
Nicola Wiles - Collaborator - University of Bristol
Stephanie MacNeill - Collaborator - University of BristolOutcomes:
This project will explore trends in benzodiazepine, antipsychotic and beta-blocker prescribing for anxiety, in the UK between 2003 and 2018.
Description: Technical Summary
This study will investigate prescribing of benzodiazepines, antipsychotics and beta-blockers for the indication of anxiety, between 2003-2018. The study will use a retrospective cohort design, including patients aged 18+.
For the benzodiazepine analysis, patients will be excluded if they ever have a recorded epilepsy or muscle spasticity code, or an alcohol withdrawal code in the six months before the prescription. For the antipsychotic analysis, patients will be excluded if they have a psychosis code in the five years before the prescription. A sensitivity analysis will exclude those who ever have a psychosis code. For the beta-blocker analysis, patients will be excluded if they have a neurological code in the year before the prescription, with a sensitivity analysis excluding those where it occurs in the three years prior. Again, for the beta-blocker analysis, patients will be excluded if they have a cardiovascular code in the five years before the prescription, with a sensitivity analysis excluding those who ever have a cardiovascular code.
The prescription must have occurred within the 3 months before an anxiety code date, or the 6 months afterward.
For each drug class, we will calculate the number of patients who received at least one benzodiazepine, antipsychotic or beta-blocker prescription (monotherapies and combination treatment), and the number of patients who started such medication in each calendar year. Person-years-at-risk will be the denominator. Incidence rates and 95%CI will be calculated using Poisson regression. Data will be plotted to examine patterns of prescribing over time. Changes in trends over time will be examined using joinpoint regression. Data will be stratified by age and gender. We will calculate average treatment duration for incident cases to examine whether long-term prescribing has changed. This work will enable understanding of how prescribing trends have changed over 16-years for the large number of patients with anxiety.
Source -
Incretin-based drugs and the incidence of prostate cancer among patients with type 2 diabetes — Samy Suissa ...
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Incretin-based drugs and the incidence of prostate cancer among patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-29
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sally Lu - Collaborator - McGill UniversityOutcomes:
The outcome of interest is an incident diagnosis of prostate cancer, as determined by pre-specified Read codes (listed in Appendix 1).
Description: Technical Summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide receptor agonists (GLP-1 RAs) are commonly prescribed for managing glucose levels in type 2 diabetes. These incretin-based drugs have several advantages over other anti-diabetic drugs, which include their favourable effects on body weight and decreased risk of hypoglycemia. There is also some evidence that these drugs may reduce the growth of prostate cancer cells. To date, however, there is a paucity of research on the association between the use of incretin-based drugs and the incidence of prostate cancer in the real-world setting. Thus, the objective of this study is to determine whether the use of GLP-1 RAs and DPP-4 inhibitors, separately, is associated with a decreased risk of prostate cancer among men with type 2 diabetes. This study using the Clinical Practice Research Datalink will compare new users of incretin-based drugs (DPP-4 inhibitors and GLP-1 RAs) with new users of sulfonylureas from January 01, 2007 to July 31, 2019, with follow-up until July 31, 2020. Propensity score fine stratification will be used to control for confounding, and Cox proportional hazards models will be used to estimate hazards ratios and 95% confidence intervals of prostate cancer associated with the use of incretin-based drugs, compared to the use of sulfonylureas.
Source -
Alternative Confounding Control Approaches for the Prevalent New User Study Design: An Empirical Example Assessing the Effects of Antidiabetic Drug Exposure (sulfonylureas and GLP-1 analogs) on Hospitalization for Heart Failure — Panagiotis Mavros ...
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Alternative Confounding Control Approaches for the Prevalent New User Study Design: An Empirical Example Assessing the Effects of Antidiabetic Drug Exposure (sulfonylureas and GLP-1 analogs) on Hospitalization for Heart Failure
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-13
Organisations:
Panagiotis Mavros - Chief Investigator - Janssen Scientific Affairs, LLC
Shahar Shmuel - Corresponding Applicant - University of North Carolina at Chapel Hill
Cynthia Girman - Collaborator - CERobs Consulting
Elizabeth Garry - Collaborator - Aetion, Inc
Jerrod Nelms - Collaborator - Janssen Scientific Affairs, LLC
Jessica Young - Collaborator - University of North Carolina at Chapel Hill
Michael Webster-Clark - Collaborator - University of North Carolina at Chapel Hill
Til Stürmer - Collaborator - University of North Carolina at Chapel HillOutcomes:
Outcomes to be measured
For the primary objective, the two outcomes of interest are: (1) indicators of matching success, and (2)
computation time. Indicators of matching success will include (a) proportion of patients where matches are found, and (b) balance metrics. Balance metrics will be assessed using standardized mean differences (SMDs) for the confounders and time since starting a GLP-1 analog, contrasting the cohort of switchers to GLP-1 with the cohort of sulfonylureas continuers. Computation time will be assessed on a remote computer running the program with no other programs running in the background or by running programs in parallel.For the secondary objective, the primary outcome of interest will be hospitalization for heart failure. This outcome will be identified using inpatient diagnostic codes through the HES linkage. In CPRD, heart failure will be defined using International Classification of Diseases, 10th Revision codes (ICD-10 [I50.x]). For patients with no history of heart failure, the event definition will require a diagnosis in the primary or secondary position for the hospital stay. For patients with a history of heart failure, the event definition will exclude heart failure as a secondary diagnosis.
For the secondary objective, the secondary outcome of interest will be heart failure, assessed using outpatient diagnostic codes through the HES linkage. In CPRD, heart failure will be defined using the ICD-10 code I50.x or any of the following Read codes (G1yz100, G58..00, G580.00, G580000, G580100, G580.11, G580.12, G580.13, G580.14, G580200, G50300, G580400, G581.00, G581000, G58..11, G581.11, G581.12, G581.13, G582.00, G583.00, G583.11, G583.12, G584.00, G58z.00, G58z.11, G58z.12).4 For patients with no history of heart failure, the event definition will require a diagnosis in the primary or secondary position for the hospital stay. For patients with a history of heart failure, the event definition will exclude heart failure as a secondary diagnosis.
Lastly, for the exploratory objective, the outcome of interest will be the same as for the secondary objective but the analysis will be conducted using an intention-to-treat (ITT) approach instead of an As-Treated approach.
Description: Technical Summary
It is often useful to compare outcomes among patients continuing therapy with a given agent to those of patients that initiate therapy with another, potentially newer, agent. Switching to another therapeutic agent maybe associated with disease progression (or lack of therapeutic effect/side effects of the prior agent) and can be influenced by treatment guidelines and formulary design. This scenario can be handled using the prevalent-new-user study design (PNUD). Whereas the traditional new-user design is restricted to true new users, the PNUD includes patients switching treatment, thereby increasing study generalizability. This design may also better mimic the population seen in clinical practice. However, implementing this design can be hindered by computational difficulties stemming from the confounding control approach. The PNUD was originally implemented using a resource-intensive matching approach. Alternative matching approaches and other confounding control methods may overcome the technical problems faced with the original matching approach. This study will build on a recent simulation study comparing multiple propensity score matching approaches to each other as well as to time-stratified standardized morbidity ratio weighting and outcome modeling using the G-formula. Using CPRD data, this study will replicate the original PNUD matching approach and compare a subset of the confounding control methods considered in the simulation study. This study will contribute an empirical application comparing multiple confounding control approaches, thereby advancing our understanding of implementation of the PNUD using real world data. Our empirical application will be the same as in the original PNUD study: we will compare exposure to two anti-diabetic drugs (GLP-1 analogs and sulfonylureas) in relation to the hazard of hospitalization for heart failure. This important clinical question can help clinicians decide whether it would be better for their patients to switch to GLP-1 analogs or remain on sulfonylureas.
Source - and 11 more projects — click to show
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Risk of Venous Thromboembolism After Knee, Hip or Shoulder Replacement: A Retrospective Cohort Study Using Linked Hospital and Primary Care Data — John Powell ...
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Risk of Venous Thromboembolism After Knee, Hip or Shoulder Replacement: A Retrospective Cohort Study Using Linked Hospital and Primary Care Data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-08
Organisations:
John Powell - Chief Investigator - University of Oxford
Nadja Leith - Corresponding Applicant - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Jonathan Rees - Collaborator - University of Oxford
Sarah Brown - Collaborator - University of Oxford
Subhashisa Swain - Collaborator - University of OxfordOutcomes:
Venous Thromboembolism (deep vein thrombosis; pulmonary embolism) recorded in primary care, secondary care or on death certificate in the 6 months after joint replacement surgery.
Description: Technical Summary
Venous Thromboembolism (VTE), a term including both deep vein thrombosis and pulmonary embolism, can be a serious complication after joint replacement surgery. UK studies to measure the risk of VTE after joint replacement surgery have thus far looked exclusively at hospital data. However, using hospital data alone may substantially underestimate post-surgical VTE risk [1,5]. This retrospective cohort study will therefore use three data sources combined to better estimate the VTE risk after joint replacement surgery: hospital data (Hospital Episode Statistics), primary care data (Clinical Practice Research Datalink) and death certificate information (Office of National Statistics).
This study has two main aims. The first is to provide comprehensive, joint-specific estimates of VTE risk in the six months after primary knee, hip and shoulder replacement surgery, and to explore changes in risk over time. Logistic regression will be used to investigate temporal variations in VTE risk from October 2007 to February 2020, including potential seasonal patterns and step changes in risk due to National Institute of Health and Care Excellence (NICE) guideline updates (e.g. NG89, released in March 2018, covering the assessment and management of VTE risk in hospitals).
The second aim of this study is to better understand patient specific VTE risk in the six months after primary knee, hip or shoulder replacement surgery. VTE risk will be related to patient covariates, region and date of surgery using a random forest model (RFM) in order to allow for complex, interactive and nonlinear relationships. The relationship between risk and patient attributes will be explored, as will regional and temporal variations in risk when holding patient attributes constant. We will also use the similarity matrix resulting from the RFM to cluster patients into groups of relatively homogenous risk, which could provide important information for future NICE guideline updates.
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Age-specific mortality rates of males diagnosed with Duchenne Muscular Dystrophy. — Mark Rutherford ...
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Age-specific mortality rates of males diagnosed with Duchenne Muscular Dystrophy.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-05
Organisations:
Mark Rutherford - Chief Investigator - University of Leicester
Jonathan Broomfield - Corresponding Applicant - University of Leicester
Keith Abrams - Collaborator - University of York
Michael Crowther - Collaborator - Karolinska Institute Sweden
Michael Sweeting - Collaborator - University of LeicesterOutcomes:
All-cause mortality; spinal surgery; cardiomyopathy
Description: Technical Summary
Duchenne Muscular Dystrophy (DMD) is a rare, muscle-degeneration disease predominantly affecting males. The mainstay of treatment for DMD are corticosteroids, which have been shown to delay the decline in many functions and even prolong life. Many new treatments for DMD are currently in development. A multi-state natural history model is being constructed that captures the full disease pathway of DMD and to which treatment effects of new medicines can be applied to work out cost-effectiveness, for health technology decision-makers such as NICE.
External data has been used to populate the majority of the natural history model; however, mortality data is severely lacking, especially for UK patients treated with more recent standards of care. Additionally, the order in which patients progress through later stages of the disease is a key part of the model for which evidence is lacking.
The primary objective of this research is to estimate age-specific mortality rates for males diagnosed with DMD. The impact of corticosteroids on these mortality rates will be investigated. These rates will be used to inform a natural history model of DMD patients. New methods for constructing multi-state natural history models of rare diseases will also be developed in this research to reflect the often varied nature of data sources.
The exposure is patients with a DMD diagnosis and the outcome is all-cause death, with secondary disease characteristics of spinal surgery and cardiomyopathy also of interest. Death will be defined by ONS mortality data, where available; otherwise, by CPRD primary data. Where death date is missing, the date the patient was last known to be alive will be informed by HES Admitted Patient Care, HES Outpatient and CPRD primary data. Mortality rates for specific ages will be estimated using survival regression. They will also be adjusted by corticosteroid use in the secondary analysis.
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Managing cardiovascular disease and risk in Covid-19 patients in primary care medicine — Olaf Klungel ...
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Managing cardiovascular disease and risk in Covid-19 patients in primary care medicine
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-08
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Geert-Jan Geersing - Collaborator - University Medical Centre Utrecht
Hendrika van den Ham - Collaborator - Utrecht University
Sander van Doorn - Collaborator - University Medical Centre UtrechtOutcomes:
For this study, the main outcome consists of cardiac and thrombo-vascular complications, including:
⢠Transient ischaemic attack (TIA)
⢠Ischaemic stroke
⢠Atrial fibrillation (AF)
⢠Peripheral artery disease (PAD)
⢠Acute coronary syndrome (ACS), consisting of acute myocardial infarction (AMI) and unstable angina
⢠Venous thromboembolism (VTE), consisting of deep vein thrombosis (DVT) and pulmonary embolism (PE);Description: Technical Summary
From late 2019 onwards, the spread of the novel corona virus SARS-CoV-2 reached pandemic proportions. While the resulting infectious disorder Covid-19 showed a mild disease course in most patients, a small proportion of patients developed critical illness, necessitating oxygen admission or ICU admission with mechanical ventilation, and sometimes leading to death. Early studies showed a clear association of Covid-19 with cardiovascular disease. From an epidemiological aspect, there were clear observations showing an overrepresentation of patients with a history of cardiovascular disease and metabolic risk factors (e.g. diabetes and obesity) in those entering hospital care. Pathophysiological explanations for these observations might involve endothelial involvement, vascular leakage, hypercoagulability and thrombosis in Covid-19 patients with critical illness.
The large population of Covid-19 patients treated in primary care, however, is less well studied, although in this setting timely targeting cardiovascular involvement in Covid-19 might prevent deterioration. This study aims to estimate the incidence of cardiac and thrombo-vascular complications in patients with Covid-19 seen in primary care. Incidence rates will be presented as number of events per 90 person days of follow-up since point of first contact with primary care. Next, we aim to develop a prognostic prediction model in these patients to quantify absolute risks of cardiac and thrombo-vascular complications. Multivariable logistic regression will be performed to obtain adjusted odds ratios with corresponding confidence margins of the relevant predictors of cardiac and thrombo-vascular complications. Last, this study aims to estimate the relative effectiveness of antithrombotic treatment in patients with Covid-19 for preventing these aforementioned adverse outcomes. Potential confounding by indication will be addressed using propensity scoring methods.
Ultimately, this study helps general practitioners to identify patients at high risk of critical illness, monitor them more closely, timely refer them to a hospital, or prescribe preventive cardiovascular medication earlier.
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Identifying the clinical risks associated with COVID-19 in patients with congenital heart disease and associated co-morbidities — Bernard Keavney ...
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Identifying the clinical risks associated with COVID-19 in patients with congenital heart disease and associated co-morbidities
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Admitted Patient Care; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation (index other than the most recent); SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-22
Organisations:
Bernard Keavney - Chief Investigator - University of Manchester
Simon Williams - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Dominic Byrne - Collaborator - University of Manchester
jing yang - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Simon Frain - Collaborator - University of ManchesterOutcomes:
COVID-19 hospital admission rates for congenital heart disease patients; COVID-19 death rates for congenital heart disease patients; Comorbidities associated with congenital heart disease and subtypes; The overall risk of COVID-19 and other medical complications in patients with congenital heart disease
Description: Technical Summary
COVID-related recommendations to congenital heart disease (CHD) patients have thus far been made based on clinical consensus. COVID outcomes for different groups of CHD patients have not been accurately quantified in largescale datasets. The phenotypic complexity of CHD, and the increasingly recognised presence of significant comorbidities (for example coronary artery disease) in adults with even mild CHD, mandates a largescale analysis taking into account both the heterogeneity of CHD and the potential influence of comorbidities on COVID outcome.
We will use the CPRD Aurum database to classify CHD patients and non-CHD patients, using a schema based on OPCS and ICD codes we developed in the analysis of UK Biobank data. Age, sex and ethnicity matched non-CHD patients from the same general practice will be selected as a control group, matched 4:1 with the cases.
First, we will investigate the prevalence of comorbid conditions in CHD cases versus controls using Cox regression, accounting for confounders. We will use marginal structural models for more complex comorbidity analysis where the association may be conditional on time-dependent exposures with time-dependent covariates.
Second, we will assess COVID-19 outcomes in the CHD cohort compared to controls, adjusting for comorbidities by logistic regression. We will determine COVID positivity via SGSS linkage. The CHESS, ICNARC and ONS death registration data will enable us to determine severity of COVID-19 health outcomes with regard to the primary endpoint of mortality, and the secondary endpoint of hospital admission. We will use instrumental variable analysis to examine whether any difference in COVID outcome between cases and controls is accounted for by the presence of comorbidities.
The study will inform health policy regarding the clinical management of CHD patients during COVID-19. In addition, it will potentially highlight comorbidities of CHD that require intensified monitoring, particularly as the pandemic moves to an endemic situation.
Source -
An observational study to generate machine learning and statistical models to predict suicide using Clinical Practice Research Datalink (CPRD) electronic health records. — James Bailey ...
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An observational study to generate machine learning and statistical models to predict suicide using Clinical Practice Research Datalink (CPRD) electronic health records.
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-04
Organisations:
James Bailey - Chief Investigator - King's College London (KCL)
James Bailey - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Grigorios Loukides - Collaborator - King's College London (KCL)
Johnny Downs - Collaborator - King's College London (KCL)
Rina Dutta - Collaborator - King's College London (KCL)
Vibhore Prasad - Collaborator - King's College London (KCL)Outcomes:
The primary outcome will be suicide.
Description: Technical Summary
Background and rationale
Globally, 800,000 people die from suicide every year, a rate of 10.6 per 100,000 person-years. Suicide is the leading cause of death for those aged 20 to 34 in the UK with a rate of 11 deaths per 100,000.
Prediction of suicide is difficult; prediction tools have been developed based on well-established risk factors and traditional statistical methods, but have not been accurate enough to be widely adopted in healthcare settings and are not recommended by the National Institute for Health and Care Excellence.
The 2012 suicide prevention strategy and subsequent Health Select Committee's inquiry into suicide prevention highlights the role GPs play in identifying and managing suicide risk. Machine learning is an emerging technology in healthcare research and has been applied to answer questions using CPRD data previously but, to our knowledge, not to suicide risk assessment.
Previous machine learning models for suicide risk prediction have used the area under the receiver operator characteristic curve (AUC) to compare model performance. Models have shown good AUCs but when calculated, positive predictive value still remains low. We believe that model performance would be better assessed by calculating the net-benefit of the model. Calculating net-benefit involves understanding what intervention might be offered to patients who are considered at risk by the model and incorporates the risks involved with false positives and false negatives. We believe this will give a more interpretable model output and is the next step towards producing a viable clinical risk scoring toolObjectives
To build a machine learning model for suicide from Primary Care data which can produce a net-benefit to patients.
Source -
A risk prediction model to predict incident heart failure (RiskHF): derivation and validation cohort study — Clare Taylor ...
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A risk prediction model to predict incident heart failure (RiskHF): derivation and validation cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-22
Organisations:
Clare Taylor - Chief Investigator - University of Oxford
Clare Taylor - Corresponding Applicant - University of Oxford
Andrea Roalfe - Collaborator - University of Oxford
José M. Ordóñez-Mena - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of OxfordOutcomes:
The primary outcome will be a diagnosis of HF in the primary care, hospital record or death certificate in the next 12 months. The index date will be the earliest from all three sources. Participants with a diagnosis of HF will be identified using diagnostic codes entered by GPs or hospital specialists to record new diagnoses in the primary or secondary care medical record, respectively, or by the clinician completing a death certificate using ONS mortality data. The NHS Clinical Terminology Browser and Quality and Outcomes Framework guidelines will be used to generate a comprehensive list of terms used to code for a diagnosis of HF. HF is a clinical syndrome and the diagnosis requires the presence of symptoms and objective evidence of a structural or functional abnormality of the heart. Patients with a clinical code of HF and/or an echocardiograph report or a record of HF in linked HES records will be classified as being a case of HF. Echocardiograms will be identified using clinical codes and entity code 342. Two distinct types of HF are now recognised by researchers and the clinical community based on the left ventricular ejection fraction: HF with reduced Ejection Fraction (HFrEF) and HF with preserved Ejection Fraction (HFpEF). We will search for these codes in the patient record, and ejection fraction results from echocardiogram reports to establish whether it is possible to report HFrEF and HFpEF rates separately. These codes have only recently been recorded in clinical practice so it may not be possible to distinguish between HFrEF and HFpEF, in which case a diagnosis of HF will be used.
Description: Technical Summary
Heart failure (HF) is a common, costly, and treatable condition. Evidence-based therapies can improve quality of life and survival once a diagnosis is made, but currently 80% of people are diagnosed on hospital admission. Rapid diagnosis in primary care could improve patient experience and outcome. We aim to derive and validate a robust risk prediction model (âRiskHFâ) to identify patients likely to develop HF.
The Clinical Practice Research Datalink contains demographic data and clinical codes for over 15 million patients, and is linked to Hospital Episode Statistics and Office for National Statistics mortality data. We will carry out an open cohort study from 1st January 2000 to 31st December 2020 and split the dataset into derivation and validation cohorts. The primary outcome will be a diagnosis of HF in the next 12 months. Predictor variables will include patient demographics, HF symptoms, cardiovascular risk factors, co-morbidities and prescriptions. We will use Cox proportional hazards to derive risk equations for men and women then evaluate the performance of the model in the validation cohort.
The RiskHF tool could be used in new HF pathways to identify patients for natriuretic peptide testing and referral to facilitate earlier diagnosis and treatment.
Source -
Event Rates and Risk Factors for Atherosclerotic Cardiovascular Disease Events in High-Risk Primary Prevention and Atherosclerotic Cardiovascular Disease Populations in United Kingdom — Pia Horvat ...
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Event Rates and Risk Factors for Atherosclerotic Cardiovascular Disease Events in High-Risk Primary Prevention and Atherosclerotic Cardiovascular Disease Populations in United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-07-19
Organisations:
Pia Horvat - Chief Investigator - IQVIA Ltd
Nelly Ly - Corresponding Applicant - IQVIA Ltd
Alexandra Koumas - Collaborator - Axtria Inc. USA
Ankita Chauhan - Collaborator - Axtria Inc. USA
Anna Castelo Branco - Collaborator - IMS Health Sweden AB
Aurore Tricotel - Collaborator - IQVIA Operations France SAS
Christian Siegfried - Collaborator - Axtria Inc. USA
Christopher Lee - Collaborator - IQVIA Ltd
Emil Vatov - Collaborator - IQVIA Solution Bulgaria EOOD
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Jessica Lundbom - Collaborator - IQVIA Ltd
Louise Raiteri - Collaborator - IQVIA Ltd
Nelly Ly - Collaborator - IQVIA Ltd
Nicole Rutishauser - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Oriane BRETIN - Collaborator - IQVIA Operations France SAS
Quratul Ann - Collaborator - IQVIA Ltd
Sophia Rodopoulou - Collaborator - IQVIA Hellas Technology Solutions S.A.
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Sushant Pal - Collaborator - Axtria India Pvt. Ltd.
Tarana Mehdikhanova - Collaborator - IQVIA Ltd
Vanessa Marzola - Collaborator - IMS Health Sweden ABOutcomes:
Primary outcomes will be defined as the composite of nonfatal myocardial infarction (MI), nonfatal ischemic stroke, and cardiovascular (CV) death.
Secondary outcomes will be defined as nonfatal MI, nonfatal ischemic stroke, CV death, unstable angina hospitalization, and elective coronary revascularization as a composite outcome and separately, and all-cause mortality.
Descriptive variables during the follow-up will be lipid lowering therapies (LLT) (including statins, ezetimibe, and PCSK9 inhibitors) and achieved low-density lipoprotein cholesterol (LDL-C) levels.Description: Technical Summary
This study is a longitudinal retrospective observational cohort study based on a population with high and very high-risk of atherosclerotic cardiovascular disease (ASCVD) events (per the 2019 European Society of Cardiology and European Atherosclerosis Society dyslipidaemia guidelines), determined from Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases in the United Kingdom. In addition to information on patient demographics and clinical characteristics, CPRD database will be utilized for treatment patterns and laboratory measures including low-density lipoprotein cholesterol (LDL-C), and HES and Office for National Statistics (ONS) databases to follow-up the study outcomes. Primary and first secondary objectives will describe event rates over time via Kaplan-Meier analyses for the primary outcome (a composite of nonfatal myocardial infarction (MI), nonfatal ischemic stroke, and cardiovascular (CV) death) and for the secondary outcomes (nonfatal MI, nonfatal ischemic stroke, CV death, unstable angina hospitalization, and elective coronary revascularization as a composite outcome and separately, and all-cause mortality), respectively. Possible risk factors for the primary and secondary outcomes will be assessed via Cox proportional hazards models and will include patient demographics, clinical characteristics, laboratory measures, lifestyle, and medication characteristics. Summary statistics of these variables will be provided as part of the second secondary objective. To address the last secondary objective, proportion of patients on various therapies, proportion of patients within categories of achieved LDL-C, rates of treatment-related events including treatment initiation, intensification, discontinuation, and re-start, and LDL-C levels will be described. Analyses will be provided separately for 1) high-risk primary prevention population without ASCVD and 2) population with ASCVD, and further stratified by index event. The knowledge generated by this study will help informing indirectly clinical practices guidelines (whether treatments are appropriately prescribed in these populations) and public health policy (whether some clinical conditions should be emphasized for the prevention of CV events).
Source -
Extension: Volunteering Programme Evaluation – NWL ICS
— Imperial College Health Partners...
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Extension: Volunteering Programme Evaluation – NWL ICS
Legal basis:Service evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: North West London.
Source -
ID-139: North Kensington Recovery (Grenfell) Programme — NHS North West London Clinical Commissioning Group...
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ID-139: North Kensington Recovery (Grenfell) Programme
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-21
Opt Outs: no information provided./p>
Organisations: NHS North West London Clinical Commissioning Group
Description: Grenfell.
Source -
ID-140: Analysis of WSIC data to support London Borough of Hillingdon Joint Strategic Needs Assessment — Brunel University London...
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ID-140: Analysis of WSIC data to support London Borough of Hillingdon Joint Strategic Needs Assessment
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-21
Opt Outs: no information provided./p>
Organisations: Brunel University London
Description: Hillingdon.
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ID-138: Mixed methods evaluation of the impact of the shift to remote consultation in primary and secondary care in London — Imperial College London...
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ID-138: Mixed methods evaluation of the impact of the shift to remote consultation in primary and secondary care in London
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-21
Opt Outs: no information provided./p>
Organisations: Imperial College London, NIHR Applied Research Collaboration North West London
Description: Remote Consultations.
Source
2021 - 06
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ADR UK Research Fellows: The first users of the Data First magistratesâ and Crown Court datasets — unknown...
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ADR UK Research Fellows: The first users of the Data First magistratesâ and Crown Court datasets
Where: unstated
When: 2021-6-16
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding four Research Fellows for seven to 12 months to conduct analysis using the Data First magistratesâ or Crown Court linked datasets, or a linking dataset enabling analysis of relationships between the two. Both datasets contain case and defendant level data on criminal court use between 2011 and 2020.
They form the first cohort of Data First Fellows and the first funded users of the de-identified, research-ready datasets made available via the Data First programme. Data First is a ground-breaking data linkage programme led by the Ministry of Justice (MoJ) and funded by ADR UK to link and enable access to administrative data from across the justice system and beyond for research.
Find out more about the Research Fellows and their projects below.
Source -
Demographic, socioeconomic, temporal, and spatial patterns in the prescription of contraceptives within UK primary care — Mike Lonergan ...
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Demographic, socioeconomic, temporal, and spatial patterns in the prescription of contraceptives within UK primary care
Datasets:GP data, Contraceptive product prescribed, broken down by category (injectables, pills, intra-uterine devices and systems, implants, patches, and non-hormonal contraceptives); number of contraceptive products prescribed in 12-month periods; incidence, duration, and prevalence, and variability of use. All stratified by: age; socioeconomic status; ethnicity; geographic location; gender, number of previous pregnancies, year of prescription.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-20
Organisations:
Mike Lonergan - Chief Investigator - CPRD
Mike Lonergan - Corresponding Applicant - CPRD
Eleanor Axson - Collaborator - CPRD
Helen Booth - Collaborator - CPRD
Karen Cuenco - Collaborator - The Gates Foundation
Martin Holding - Collaborator - CPRD
Preeti Datta-Nemdharry - Collaborator - MHRA
Sergey Feldman - Collaborator - The Gates FoundationOutcomes:
Contraceptive product prescribed, broken down by category (injectables, pills, intra-uterine devices and systems, implants, patches, and non-hormonal contraceptives); number of contraceptive products prescribed in 12-month periods; incidence, duration, and prevalence, and variability of use. All stratified by: age; socioeconomic status; ethnicity; geographic location; gender, number of previous pregnancies, year of prescription.
Description: Technical Summary
Hormonal, and other medical, contraceptives provide reversible fertility management and therefore give women control of this important aspect of their lives. Access, and lack of access, to contraception have been recognised as important determinants of the opportunities available to women in developing countries and the patterns of inequality across and within those countries. Less work has been done on these problems in developed nations, though the existence of inequality and social exclusion are again obvious.
The CPRD Aurum and GOLD datasets capture primary care prescriptions along with many other details of people's lives. They cover a substantial proportion of the UK population over the last 20 years, and, in England, are linked to further information on measures of socioeconomic deprivation and whether individuals live in rural or urban environments. In this study, we will use linkages to Hospital Episode Statistics Admitted Patient Care, patient level Index of Multiple Deprivation and Rural Urban Classification data.
There are limits to these data, including that prescriptions written in specialist clinics and services are not currently captured. Despite this, the datasets contain a large amount of information that will allow both investigation of patterns in the available data and comparisons with other sources of information to assess biases.
The aim of this project is to identify differences in region, age, socioeconomic status, parity and ethnicity in the use of prescription contraceptives (e.g., the combined pill, intra-uterine devices/systems, implants and patches), and to look at how all these have changed over the period from first prescription to present. The main analyses will be generalised linear models, looking at the numbers and proportions of individuals prescribed to. Its main purpose is descriptive: to provide baseline information for future studies, and to assess completeness of data in CPRD GOLD and Aurum through comparison with external data sources.
Source -
Socio-economic inequalities in prevalence and management of long-term conditions in primary care: a descriptive study — Nils Gutacker ...
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Socio-economic inequalities in prevalence and management of long-term conditions in primary care: a descriptive study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-30
Organisations:
Nils Gutacker - Chief Investigator - University of York
Nils Gutacker - Corresponding Applicant - University of York
Anne Mason - Collaborator - University of York
David Glynn - Collaborator - University of York
Luigi Siciliani - Collaborator - University of York
Luis Fernandes - Collaborator - University of York
Simon Walker - Collaborator - University of York
Susan Griffin - Collaborator - University of York
Tim Doran - Collaborator - University of YorkOutcomes:
Prevalence of 18 long-term conditions:
Atrial fibrillation
Coronary heart disease
Heart failure
Hypertension
PAD
Stroke and TIA
Asthma
COPD
Obesity
Cancer
Chronic kidney disease
Diabetes Mellitus
Dementia
Depression
Epilepsy
Severe mental illness
Osteoporosis
Rheumatoid arthritisAchievement of 44 processes of care and intermediate outcomes incentivised under the Quality Outcome Framework (QOF):
AF006. The percentage of patients with atrial fibrillation in whom stroke risk has been assessed using the CHA2DS2-VASc score risk stratification scoring system in the preceding 12 months (excluding those patients with a previous CHADS2 or CHA2DS2-VASc score of 2 or more)
AF007. In those patients with atrial fibrillation with a record of a CHA2DS2-VASc score of 2 or more, the percentage of patients who are currently treated with anti-coagulation drug therapy
CHD005. The percentage of patients with coronary heart disease with a record in the preceding 12 months that aspirin, an alternative anti-platelet therapy, or an anti-coagulant is being taken
CHD007. The percentage of patients with coronary heart disease who have had influenza immunisation in the preceding 1 August to 31 March
CHD008. The percentage of patients aged 79 years or under with coronary heart disease in whom the last blood pressure reading (measured in the preceding 12 months) is 140/90 mmHg or less
CHD009. The percentage of patients aged 80 years and over with coronary heart disease in whom the last blood pressure reading (measured in the preceding 12 months) is 150/90 mmHg or less
HF002. The percentage of patients with a diagnosis of heart failure (diagnosed on or after 1 April 2006) which has been confirmed by an echocardiogram or by specialist assessment 3 months before or 12 months after entering on to the register
HF003. In those patients with a current diagnosis of heart failure due to left ventricular systolic dysfunction, the percentage of patients who are currently treated with an ACE-I or ARB
HF004. In those patients with a current diagnosis of heart failure due to left ventricular systolic dysfunction who are currently treated with an ACE- I or ARB, the percentage of patients who are additionally currently treated with a beta-blocker licensed for heart failure
HYP003. The percentage of patients aged 79 years or under with hypertension in whom the last blood pressure reading (measured in the preceding 12 months) is 140/90 mmHg or less
HYP007. The percentage of patients aged 80 years and over with hypertension in whom the last blood pressure reading (measured in the preceding 12 months) is 150/90 mmHg or less
STIA007. The percentage of patients with a stroke shown to be non-haemorrhagic, or a history of TIA, who have a record in the preceding 12 months that an anti-platelet agent, or an anti-coagulant is being taken
STIA009. The percentage of patients with stroke or TIA who have had influenza immunisation in the preceding 1 August to 31 March
STIA010. The percentage of patients aged 79 years or less with a history of stroke or TIA in whom the last blood pressure reading (measured in the preceding 12 months) is 140/90 mmHg or less
STIA011. The percentage of patients aged 80 years and over with a history of stroke or TIA in whom the last blood pressure reading (measured in the preceding 12 months) is 150/90 mmHg or less
DM006. The percentage of patients with diabetes, on the register, with a diagnosis of nephropathy (clinical proteinuria) or micro-albuminuria who are currently treated with an ACE-I (or ARBs)
DM012. The percentage of patients with diabetes, on the register, with a record of a foot examination and risk classification: 1) low risk (normal sensation, palpable pulses), 2) increased risk (neuropathy or absent pulses), 3) high risk (neuropathy or absent pulses plus deformity or skin changes in previous ulcer) or 4) ulcerated foot within the preceding 12 months
DM014. The percentage of patients newly diagnosed with diabetes, on the register, in the preceding 1 April to 31 March who have a record of being referred to a structured education programme within 9 months after entry on to the diabetes register
DM018. The percentage of patients with diabetes, on the register, who have had influenza immunisation in the preceding 1 August to 31 March
DM019. The percentage of patients with diabetes, on the register, without moderate or severe frailty in whom the last blood pressure reading (measured in the preceding 12 months) is 140/80 mmHg or less
DM020. The percentage of patients with diabetes, on the register, without moderate or severe frailty in whom the last IFCC-HbA1c is 58 mmol/mol or less in the preceding 12 months
DM021. The percentage of patients with diabetes, on the register, with moderate or severe frailty in whom the last IFCC-HbA1c is 75 mmol/mol or less in the preceding 12 months
DM022. The percentage of patients with diabetes aged 40 years and over, with no history of cardiovascular disease and without moderate or severe frailty, who are currently treated with a statin (excluding patients with type 2 diabetes and a CVD risk score of <10% recorded in the preceding 3 years)
DM023. The percentage of patients with diabetes and a history of cardiovascular disease (excluding haemorrhagic stroke) who are currently treated with a statin
AST002. The percentage of patients aged 8 or over with asthma (diagnosed on or after 1 April 2006), on the register, with measures of variability or reversibility recorded between 3 months before or any time after diagnosis
AST003. The percentage of patients with asthma, on the register, who have had an asthma review in the preceding 12 months that includes an assessment of asthma control using the 3 RCP questions
AST004. The percentage of patients with asthma aged 14 or over and who have not attained the age of 20, on the register, in whom there is a record of smoking status in the preceding 12 months
COPD002. The percentage of patients with COPD (diagnosed on or after 1 April 2011) in whom the diagnosis has been confirmed by post bronchodilator spirometry between 3 months before and 12 months after entering on to the register
COPD003. The percentage of patients with COPD who have had a review, undertaken by a healthcare professional, including an assessment of breathlessness using the Medical Research Council dyspnoea scale in the preceding 12 months
COPD007. The percentage of patients with COPD who have had influenza immunisation in the preceding 1 August to 31 March
COPD008. The percentage of patients with COPD and Medical Research Council (MRC) dyspnoea scale â¥3 at any time in the preceding 12 months, with a subsequent record of an offer of referral to a pulmonary rehabilitation programme (excluding those who have previously attended a pulmonary rehabilitation programme)
DEM004. The percentage of patients diagnosed with dementia whose care plan has been reviewed in a face-to-face review in the preceding 12 months
DEP003.The percentage of patients aged 18 or over with a new diagnosis of depression in the preceding 1 April to 31 March, who have been reviewed not earlier than 10 days after and not later than 56 days after the date of diagnosis
MH002. The percentage of patients with schizophrenia, bipolar affective disorder and other psychoses who have a comprehensive care plan documented in the record, in the preceding 12 months, agreed between individuals, their family and/or carers as appropriate
MH003. The percentage of patients with schizophrenia, bipolar affective disorder and other psychoses who have a record of blood pressure in the preceding 12 months
MH006. The percentage of patients with schizophrenia, bipolar affective disorder and other psychoses who have a record of BMI in the preceding 12 months
CAN003. The percentage of patients with cancer, diagnosed within the preceding 15 months, who have a patient review recorded as occurring within 6 months of the date of diagnosis
RA002. The percentage of patients with rheumatoid arthritis, on the register, who have had a face-to-face review in the preceding 12 months
CVD-PP001. In those patients with a new diagnosis of hypertension aged 30 or over and who have not attained the age of 75, recorded between the preceding 1 April to 31 March (excluding those with pre-existing CHD, diabetes, stroke and/or TIA), who have a recorded CVD risk assessment score (using an assessment tool agreed with NHS CB) of â¥20% in the preceding 12 months: the percentage who are currently treated with statins
BP002. The percentage of patients aged 45 or over who have a record of blood pressure in the preceding 5 years.
SMOK002. The percentage of patients with any or any combination of the following conditions: CHD, PAD, stroke or TIA, hypertension, diabetes, COPD, CKD, asthma, schizophrenia, bipolar affective disorder or other psychoses whose notes record smoking status in the preceding 12 months
SMOK005. The percentage of patients with any or any combination of the following conditions: CHD, PAD, stroke or TIA, hypertension, diabetes, COPD, CKD, asthma, schizophrenia, bipolar affective disorder or other psychoses who are recorded as current smokers who have a record of an offer of support and treatment within the preceding 12 months
CS005. The proportion of women eligible for screening aged 25-49 years at end of period reported whose notes record that an adequate cervical screening test has been performed in the previous 3 years and 6 months
CS006. The proportion of women eligible for screening and aged 50-64 years at end of period reported whose notes record that an adequate cervical screening test has been performed in the previous 5 years and 6 months
Description: Technical Summary
Reducing health inequalities in an efficient way depends on prioritising health policies according to their impact on the distribution of health across the entire population, not just on those targeted by the policy. This is because the funds used to support a health policy could have been used on other actions to improve health, potentially in different people.
Distributional cost-effectiveness analysis (DCEA) is a methodology to quantify the costs and benefits of a new health technology or health policy and how they are distributed across different population groups. DCEA helps inform policy-makers about the degree to which different population groups would gain or lose from introducing a new health policy or changing an existing policy. The method can therefore be used to assess their impact on health inequalities.
The Centre for Health Economics at the University of York has been funded by the NIHR Policy Research Programme to explore the health inequality effects of existing health policies, and to inform the design of a new health policy that incentivises the reduction in health inequalities through primary care. This CPRD research project will develop a catalogue of estimates of socioeconomic gradients in disease prevalence and the quality of primary care received under the Quality and Outcome Framework (QOF). These estimates are required to inform the DCEAs.
This study will use CPRD data for a sample of patients registered with English GP practices in two ways. First, direct standardisation against a UK reference population will be used to calculate disease prevalence rates by socio-economic group for 18 common diseases. Second, regression analysis adjusting for patientsâ socio-economic group membership, age, sex, and practice fixed effects will be used to determine differences in achievement of QOF-incentivised care standards. Patientsâ socio-economic circumstances will be approximated using the Index of Multiple Deprivation.
Source -
Development of a Pregnancy Register in the CPRD Aurum database. — Jennifer Campbell ...
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Development of a Pregnancy Register in the CPRD Aurum database.
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-30
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Hilary Shepherd - Collaborator - CPRD
Jessie Oyinlola - Collaborator - CPRD
Namir Oues - Collaborator - CPRD
Rhys Barnett - Collaborator - CPRD
Stephen Welburn - Collaborator - CPRDOutcomes:
Pregnancies and their associated outcomes in CPRD Aurum.
Description: Technical Summary
Primary care electronic health records such as the Clinical Practice Research Datalink (CPRD) GOLD and Aurum provide an excellent resource for post market safety monitoring drugs and vaccines given in pregnancy. However, ascertaining exposure status and timing is challenging. The CPRD/LSHTM GOLD pregnancy register is an extremely useful tool for researchers wishing to study pregnancy. It provides a list of all pregnancies in the database, including details such as start and end dates, trimester dates and outcome. However, there is currently no equivalent register in CPRD Aurum.
This study aims to generate a pregnancy register in CPRD Aurum . We will ascertain and characterise all sources of pregnancy data in CPRD Aurum, and adapt the algorithm used to generate the CPRD GOLD pregnancy register to create a system-agnostic version of the algorithm. We will apply the algorithm to the CPRD Aurum data to try to generate a register of all pregnancies within the database.
The resulting register will be validated at the patient level, using pregnancy records in Hospital Episode Statistics Admitted Patient Care data (HES APC). We will establish concordance between the timing of these records and those in the primary care CPRD Aurum Pregnancy Register. When the Mother Baby Link for CPRD Aurum becomes available we will also consider evidence in the linked babyâs record as evidence of pregnancy in the woman. We will compare the resulting CPRD Aurum pregnancy register to the CPRD GOLD pregnancy register, and examine the distribution of outcome types, rate of pregnancies by calendar year and age, number of pregnancy episodes per woman and the mean length of pregnancy episodes. The CPRD Aurum register will be made available to CPRD users making it easier for researchers to study new and rare pregnancy exposures in CPRD data.
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Living with dementia: understanding the prevalence of young-onset dementia — Zachary Gleisner ...
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Living with dementia: understanding the prevalence of young-onset dementia
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-27
Organisations:
Zachary Gleisner - Chief Investigator - Public Health England
Michael Jackson - Corresponding Applicant - Public Health England
Janet Carter - Collaborator - University College London ( UCL )Outcomes:
ey variables:
The sex of each patient;
The current age of each patient, measured as the difference between the current year and the patientâs year of birth;
The age at diagnosis of each patient, measured as the difference between the earliest recorded consultation date with a dementia READ/EMIS/SNOMED code and the patientâs year of birth;
The number and proportion of patients in the sample primary care database who have been diagnosed with young onset dementia;
The number of patients in NHS Digital's Recorded Dementia Diagnoses dataset who have been diagnosed with young onset dementia.
Description: Technical Summary
The purpose of this study is to determine the number and proportion of patients diagnosed with young onset dementia from this sample primary care database. The health and social care needs of people with young onset dementia are different to those diagnosed at an older age. However, as the age at diagnosis varies for each person, not all people with dementia of a similar age will have similar needs.
The number of people with dementia is published by current age group in England. However, neither age at diagnosis nor the length of time people have lived with their condition is routinely published. Commissioners and service providers need to provide interventions based on the personal needs of the individual rather than through generic age specific services.
This study will inform recommendations to national organisations that lead and develop strategy, policy and guidance on dementia care and local organisations that plan, manage and deliver different stages of clinical and preventive care. The findings will improve the quality of care of patients diagnosed with dementia by providing local estimates of the point prevalence of patients diagnosed with young onset dementia regardless of their current age.
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Identifying how best to identify pneumonia and differentiate pneumonia from asthma and chronic obstructive pulmonary disease exacerbations in routine primary care data — Jennifer Quint ...
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Identifying how best to identify pneumonia and differentiate pneumonia from asthma and chronic obstructive pulmonary disease exacerbations in routine primary care data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-23
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Chukwuma Iwundu - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Pneumonia
COPD exacerbations
Asthma exacerbationsDescription: Technical Summary
Routinely collected electronic health and administrative data of patients is a valuable tool for health and epidemiological research. The validity and generalisability of any research findings using patientsâ electronic health records (EHR) depends on accurate diagnosis of disease outcomes. Validation of various respiratory disease outcomes (e.g., pneumonia, COPD exacerbations (AECOPD) and asthma exacerbations) have been carried out by many studies. However, there is a paucity of data around accurate differentiation of pneumonia events from AECOPD and asthma exacerbation using EHR. We will investigate the diagnostic accuracy of pneumonia events in people in the general population and among those with COPD or asthma using CPRD Aurum data linked with HES APC, HES A&E, and ONS mortality data. We will validate eligible cases of pneumonia events using data on community acquired pneumonia (CAP) obtained from GP practices for various patient groups using combinations of pneumonia diagnosis code, antibiotics, symptoms, and laboratory results to confirm pneumonia events. We will also look at hospital episode statistics (HES) for patients with and without AECOPD and asthma exacerbations who have evidence of community acquired pneumonia (CAP). To evaluate the accuracy of differentiating pneumonia events from exacerbations, we will calculate sensitivity and specificity and obtain the probability of positive and negative pneumonia diagnosis using CPRD data. We will use PPV and NPV value to compare pneumonia diagnostic accuracy of various clinical features including, symptoms, laboratory investigations and chest X-rays. All calculation for diagnostic test characteristics will be carried out separately for general population, AECOPD and asthma exacerbation.
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TRial to Assess Implementation of New research in a primary care Setting (TRAINS): a pragmatic cluster randomised controlled trial of an educational intervention to promote prescription uptake in General Practitioner Practices — Steven Julious ...
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TRial to Assess Implementation of New research in a primary care Setting (TRAINS): a pragmatic cluster randomised controlled trial of an educational intervention to promote prescription uptake in General Practitioner Practices
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-16
Organisations:
Steven Julious - Chief Investigator - University of Sheffield
Rami Alyami - Corresponding Applicant - University of Sheffield
Phillip Oliver - Collaborator - University of Sheffield
Rebecca Simpson - Collaborator - University of Sheffield
Tony Stone - Collaborator - University of SheffieldOutcomes:
Primary outcome measure
ï§ The proportion of children with asthma who have a prescription for an asthma preventer medication in the months of 1 August 2021 to 30 September 2021.
Secondary outcome measures
1. The number of prescriptions of asthma preventer medication per School-aged child with asthma patient in in the period 1 August 2021 to 30 September 2021.
2. The number of prescription uptake of asthma preventer medication per patient in the month of August 2021.
3. The number of prescription uptake of asthma preventer medication per patient in the month of September 2021.
4. The proportion of children who have a prescription for asthma preventer medication per patient in the month of August 2021.
5. The proportion of children who have a prescription for asthma preventer medication per patient in the month of September 2021.
6. The number of prescription uptake of asthma preventer medication per patient in the month of September 2021.
7. The number of prescription uptake of asthma preventer medication in the 6 months following the intervention 1 July 2021.
8. The proportion of patients who have an unscheduled medical contact in the period in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
9. The number of unscheduled medical contact per patient in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
10. The proportion of patients who have a medical contact (either unscheduled and scheduled) in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
11. The total number of medical contact (either unscheduled and scheduled) per patient in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021.
12. The proportion of patients who have an unscheduled medical contact in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021 associated with respiratory diagnosis.
13. The number of unscheduled medical contacts per patient and in the period 1 September 2021 to 30 December 2021 and the individual months of 1 September 2021 to 30 December 2021associated with respiratory diagnosis.Description: Technical Summary
In school-aged children with asthma, there is a marked increase in unscheduled care after the return to school in September. This is associated with children not taking their asthma preventer medication during the school summer holidays.
A cluster randomised controlled trial (PLEASANT; Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term) was undertaken in 141 general practices (71 on intervention, and 70 on the control) in England and Wales. It was found that a simple letter sent from the family doctor sent during the school holidays to a parent with a child with asthma informing them of the importance of taking asthma medication prior to the start of the school year relatively increased prescriptions by 30% in the month prior to the start of the school year.
The TRAINS (Trial to Assess Implementation of New research in a primary care Setting) trial will assess if informing GP practices of the results of the PLEASANT trial will increase prescription uptake prior to the start of the school year. The investigation will be through a randomisation controlled trial with half the practices getting the intervention and half not. The hope is the intervention will increase implementation of the work of PLEASANT and as a result increase prescription uptake during the summer holiday prior to the start of the school. The assumption would be an increase in prescriptions uptake is associated with GP practices implementing the results of PLEASANT. CPRD will be used to obtain all data for the study which includes prescription, and primary care contacts data and to assist in the sending of the intervention.
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Does ethnicity affect the recognition of palliative care needs? An observational retrospective cohort study — Gemma Clarke ...
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Does ethnicity affect the recognition of palliative care needs? An observational retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-09
Organisations:
Gemma Clarke - Chief Investigator - University of Leeds
Gemma Clarke - Corresponding Applicant - University of Leeds
Farag Shuweihdi - Collaborator - University of Leeds
Michael Bennett - Collaborator - University of Leeds
Samuel Relton - Collaborator - University of Leeds
Sophie Trotter - Collaborator - University of LeedsOutcomes:
Primary outcomes:
1. Recognition of palliative care need by ethnic group (yes/no), variable created from presence of one of the following: palliative care local GP registration using (QOF Quality and Outcomes Framework) in CPRD; a referral to Palliative Medicine in CPRD; a referral to Palliative Medicine in HES; Palliative Medicine main specialty treatment or consultant code in HES.2. Timing of referral by ethnic group (early/late), variable constructed from date of first recognition of palliative care need (see above) to date of ONS date of death) in days.
Secondary outcomes:
1. Healthcare setting recognising palliative care needs (primary care/secondary care/emergency care) by ethnic group
2. Other demographic and clinical associations for all outcomes.Description: Technical Summary
Timely access to palliative care is associated with improvements in symptom management and quality of life, and has been shown to reduce the unnecessary use of acute care. General Practitioners (GPs) play a key role in providing palliative care for patients in the community; such as care planning, coordination, and referrals to specialist services. However, some evidence indicates inequalities in provision; for those with nonmalignant disease, and for people from ethnic minority groups.
This study will investigate the relationship between ethnicity and the recognition of palliative care needs for those with malignant and nonmalignant disease in England. The analysis will use de-identified routinely collected primary care data from the Clinical Practice Research DataLink (CPRD). A retrospective cohort of adult (18+) patients with completed ethnicity data, and a CPRD death date between (01/03/2018-to-29/02/2020) will be extracted. Extraction will include demographics, service utilisation, comorbidities and referrals. Records will be linked to Hospital Episode Statistics (HES) (inpatient/outpatient/acute) from the previous two years, including data on referrals and service utilisation. Records will also be linked to ONS death registration data and Index of Multiple Deprivation.
A recognition of palliative care needs variable (yes/no) will be created by identifying one of the following factors: palliative care QOF registration; palliative referral in CPRD/HES; palliative care treatment/main specialty (HES). A binary âlength of palliative careâ variable (early/late) will be created from death date and the date of the first recognition of palliative care need. Descriptive statistics and data visualisation will be used to describe and illustrate patterns. Multi-level logistic regression and survival analysis will be used to examine ethnic and malignant/nonmaligant differences in: recognition of need; timing; and location/site (primary/secondary/acute). Associated clinical and demographic factors will be explored, and subgroup analysis undertaken. Findings will identify areas of ethnic inequality which may be used to inform targeted interventions.
Source -
Incident Neutropenia in New Users of Cyclooxygenase-Inhibitors: An Observational Cohort Study — Susan Jick ...
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Incident Neutropenia in New Users of Cyclooxygenase-Inhibitors: An Observational Cohort Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-20
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Stephan Gut - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Jan Gaertner - Collaborator - Palliative Care Center Hildegard
Julia Spoendlin - Collaborator - University of Basel
Marlene Rauch - Collaborator - University of BaselOutcomes:
i. Incident neutropenia in new-users of cyclooxygenase-inhibitors (COX-Inhibitors).
ii. All-cause mortality within 30 days after incident neutropenia.
We will not measure sepsis or IV antibiotic use within 30 days of neutropenia as an outcome.Description: Technical Summary
We will conduct a propensity score matched retrospective cohort study to evaluate the absolute risk of neutropenia in new-users of cyclooxygenase-inhibitors (COX-Inhibitors) and the relative risk of neutropenia across different COX-Inhibitors, and of COX-Inhibitors compared to non-use of COX-Inhibitors.
We will include patients aged 2 years or older who were registered in CPRD GOLD at any time between 1990-2018 and who newly used a cohort defining COX-Inhibitor (diclofenac, ibuprofen, naproxen, coxibs, paracetamol). New use will be defined as a prescription of a cohort defining COX-Inhibitor after a period of at least 180 days in which no COX-Inhibitors were prescribed. The date of the first-time prescription will be called cohort entry date (CED). Additionally, we will identify a cohort of randomly selected non-users of COX-Inhibitors. We will exclude patients who had a record of neutropenia, agranulocytosis, HIV, substance abuse, chemotherapy, cancer, or diseases associated with neutropenia prior to CED. We will follow patients from CED until the first of the following occurs: a recorded neutropenia or an exclusion criterion, the end of drug exposure, the end of the study period, the end of data contribution or 365 days after CED, initiation of another cohort defining drug, or death. In each cohort we will calculate incidence rates of neutropenia and the proportion of patients developing neutropenia during follow-up. We will conduct propensity score matched Cox-proportional hazard analyses to calculate hazard ratios with 95% confidence intervals of the risk of neutropenia across COX-Inhibitors and of COX-Inhibitors compared to non-use. We will perform subgroup analyses by sex and age, and sensitivity analyses in which we will restrict the length of follow-up to 90 and 180 days.
Source -
Antipsychotics and risk of falls in people with Alzheimer's Disease and agitation. A self-controlled case series study and cohort study — Nawab Qizilbash ...
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Antipsychotics and risk of falls in people with Alzheimer's Disease and agitation. A self-controlled case series study and cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-30
Organisations:
Nawab Qizilbash - Chief Investigator - OXON Epidemiology - Spain
Bélène Podmore - Corresponding Applicant - OXON Epidemiology - Spain
Agueda Azpeitia - Collaborator - OXON Epidemiology - Spain
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Itziar Ubillos - Collaborator - OXON Epidemiology - Spain
Jeff Schein - Collaborator - Otsuka America Pharmaceutical Inc
Julia Agúndez - Collaborator - OXON Epidemiology - Spain
Kristian Tore Jørgensen - Collaborator - Lundbeck Limited
Madhusudan Kabra - Collaborator - Otsuka Europe
Michael Frank Mørup - Collaborator - Lundbeck A/S
MIGUEL DESCALZO - Collaborator - OXON Epidemiology - Spain
Ruth Owen - Collaborator - OXON Epidemiology - SpainOutcomes:
Primary objective
Given that a fall is an event that could affect the likelihood of a future fall, first fall leading to hospitalisation during the study period is the primary outcome. All subsequent falls will be excluded from the primary analysis and will instead be considered in the secondary analysis. History of falls in the 12 months before the index date will be included as covariate.Secondary objective
⢠All falls: first and subsequent falls leading to hospitalisations of more than 1 day during the study period that are separated from a previous hospitalisation by more than 15 days from discharge to new admission.Description: Technical Summary
We aim to provide evidence of the risk of falls leading to hospitalisation from the use of antipsychotics (AP) to manage agitation in people with Alzheimer´s disease (AD). We will also calculate the excess risk of first falls leading to hospitalisation due to the use of any APs in patients with AD and agitation.
A Self-Controlled Cases Series (SCCS) will be conducted to estimate the incidence rate ratio (IRR) using a conditional Poisson regression model. Only first fall during the study period will be considered in the primary analysis. Time variant variables such as, age, time from AD diagnosis, other AP use, stroke and living situation will need to be accounted for in the analysis.
For each eligible participant, we would classify:
⢠Antipsychotics as: atypical APs (AAP), AAP in combination with benzodiazepines, typical AP and any AP.
⢠Exposed periods will be categorised into fully exposed periods followed by a sequence of five 35-day partially exposed periods up to a maximum of 175 days. This will allow to represent a gradual shift from full exposure, to a partially exposed and to an unexposed state (1). Any time in hospital (Immortal time) will be excluded from the exposure period.A cohort design will be used to calculate the relative excess rate of falls by taking the ratio of the incidence rate (IR) of falls in patients exposed to AP and the IR of fall in those unexposed to AP.
Source - and 11 more projects — click to show
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Mortality rates, risk factors and treatment patterns in patients diagnosed with moderate-to-very-severe chronic obstructive pulmonary disease in England: a retrospective observational study using CPRD data — Caroline O'Leary ...
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Mortality rates, risk factors and treatment patterns in patients diagnosed with moderate-to-very-severe chronic obstructive pulmonary disease in England: a retrospective observational study using CPRD data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-15
Organisations:
Caroline O'Leary - Chief Investigator - IQVIA Ltd
Minouk Schoemaker - Corresponding Applicant - IQVIA Solutions B.V. (Nederland)
Clare Flach - Collaborator - IQVIA Ltd
HeloÃsa Galante - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Joshua Warden - Collaborator - IQVIA World Publications Ltd.
Mar Pujades Rodriguez - Collaborator - IQVIA
Nelly Ly - Collaborator - IQVIA Ltd
Sander Van Olst - Collaborator - IQVIA Solutions B.V. (Nederland)
Stephanie Castello - Collaborator - IQVIA
Outcomes: Exploratory analyses
Descriptive variables: smoking status, spirometry (forced expiratory volume in one second (FEV1) pre-bronchodilator and post-bronchodilator, FEV1 predicted, FEV1 % predicted pre-bronchodilator and post-bronchodilator, FVC, FEV1/FVC, FEV1/FVC predicted); COPD-related scores and biomarkers (Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT), Global Initiative for Chronic Obstructive Lung disease (GOLD) stage, 6-minutesâ walk distance (6MWD), Fractional exhaled Nitric Oxide (FeNO), fibrinogen and eosinophil (EOS) count); COPD medication (double or triple therapy regimen flag); COPD exacerbations (moderate and severe exacerbations); COPD-related Accident and Emergency (A&E) visits; COPD-related inpatient hospitalisations; non-comorbidity-related QRISK2 score components (systolic blood pressure (SBP), body mass index (BMI), total cholesterol, high density lipoprotein cholesterol ratio, family history of coronary heart disease (first-degree, aged<60)). We will also describe age-standardised all-cause mortality rates by sex.
Main analyses
Descriptive variables as at the index date (the date by which all inclusion criteria are met with an appropriate look-back period applied): demographic, clinical and lifestyle characteristics (e.g. age, sex, patient index of multiple deprivation, BMI, smoking status, comorbidities (ischaemic heart disease, heart failure, stroke, heart arrhythmia, bronchiectasis, diabetes, osteoarthritis, osteoporosis, inflammatory bowel disease, depression, anxiety, panic attack, rheumatoid arthritis and peptic ulcer); COPD-related factors and biomarkers (e.g. mMRC, FEV1, CAT, GOLD stage, 6MWD, fibrinogen and EOS count); COPD-related medication (e.g. inhaled corticosteroids (ICS), long-acting beta agonists (LABA), long-acting muscarinic antagonists (LAMA) and their combinations); QRISK2 score; pneumonia risk score; COPD exacerbations (moderate and severe exacerbations); calendar year of the index date. We will also derive mortality rates and standardised mortality ratio.
Descriptive variables during the follow-up: COPD-related medications (as described in detail later in the document) and FEV1.
Outcomes for the regression models: all-cause and COPD-related mortality, major adverse cardiovascular events (MACE), pneumonia event, moderate exacerbation event, severe exacerbation event.Description: Lay Summary
Chronic obstructive pulmonary disease (COPD) is a common lung condition that causes breathing difficulties such as breathlessness, coughing and wheezing. As these symptoms get worse, it can lead to the patient needing to be treated in hospital and may lead to death. The severity of the disease is measured on a scale ranging from mild, moderate, severe to very severe. This study focuses on those with moderate-to-very-severe COPD. The study aims to investigate risk of death from all causes, understand which factors influence the risk of death, and describe medication used in patients diagnosed with moderate-to-very-severe COPD in England.
Technical Summary
First, we will investigate whether the population in the CPRD database is representative of the population of England with respect to mortality (i.e. death rates) and explore the availability of information needed for our study among all COPD patients in the CPRD database, such as data on lung function tests.
Dependent upon these results, we will specify criteria to select the subgroup of COPD patients to be included in our analyses. We will calculate the risk of death, e.g. by comparing the risk of death to a group of patients with similar characteristics and investigate whether factors such as age, socioeconomic status, lung capacity and prescribed treatments affect the probability of death. We will describe treatments that those patients received and investigate what patient and clinical characteristics led to patients receiving particular types of treatment. With this knowledge, doctors can monitor COPD patients more appropriately and manage their treatment more effectively.This is an observational retrospective cohort study using CPRD-HES-ONS linked data aiming to describe treatment patterns and mortality among moderate-to-very-severe COPD patients in England, and to investigate risk factors for receiving particular treatments, death and other COPD-related outcomes. The study will include COPD patients who are eligible for linkage to HES and ONS. HES data will be used to determine COPD exacerbations, while ONS data will be used to obtain details on deaths.
Exploratory analyses will assess the representativeness of the entire CPRD-HES-ONS linked population in terms of mortality, by comparing age-standardised sex-specific all-cause mortality rates in this population to published mortality statistics. We will assess availability of COPD parameters among COPD patients and assess the impact of applying specific selection criteria on the sample size, to help inform the main analyses.
In the main analyses, only moderate-to-very-severe COPD patients will be considered. We will describe demographic and clinical characteristics, calculate mortality rates and estimate either absolute mortality, through a Weibull regression, or mortality relative to a âgeneral populationâ comparison group within the CPRD dataset, by calculating the standardized mortality ratio and hazard ratio. A survival model will be applied to assess the association between COPD-related factors and mortality. The COPD Galaxy model will be fitted to the COPD cohort to derive predicted probabilities of death and compare observed versus expected deaths. We will describe COPD treatments at baseline and at first switch. Patient characteristics will be compared based on baseline treatment using chi-squared tests, and one-way or Kruskal-Wallis ANOVA as appropriate. The association between risk factors and treatments will be assessed with logistic regression models. Kaplan-Meier time-to-event analyses will be performed for first treatment switch. Treatment pathways will be visualized using a Sankey diagram. Risk of COPD outcomes will be compared by treatment using a Cox proportional hazards model.
Source -
Prescription of blood pressure lowering and lipid lowering treatment in the UK and New Zealand: a cross sectional study — Emily Herrett ...
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Prescription of blood pressure lowering and lipid lowering treatment in the UK and New Zealand: a cross sectional study
Datasets:GP data, Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-09
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rod Jackson - Collaborator - University of Auckland
Sue Wells - Collaborator - University of AucklandOutcomes:
The outcomes will be prescription of:
⢠blood pressure lowering medications, and
⢠lipid lowering medications
on the study date (1st July 2019), including incident prescriptions on study date and prevalent prescriptions (i.e. those made prior to the study date whose duration overlaps with the study date, e.g. a prescription for three months of drugs made up to three months prior to study date).The repeated analyses in 2020 and 2021 will ascertain the same outcomes on 1st July 2020 and 1st July 2021.
Description: Technical Summary
Background
The UK has well established guidelines for the management of cardiovascular disease risk factors. Lipid lowering treatment is recommended based on predicted absolute cardiovascular disease risk. Blood pressure lowering treatment is recommended largely on the basis of blood pressure cut-offs.Each GP is advised to combine guideline recommendations, clinical judgement and shared decision making with the patient to decide upon treatment. Adherence to guidelines therefore depends on a multitude of GP and patient factors.
Aim
The overall aim of this study is to examine the prevalence of prescriptions for blood pressure lowering treatment and lipid lowering treatment, and to identify missed opportunities and inequalities in care. The study will also evaluate the impact of the UK coronavirus pandemic on prescriptions.Methods
Initially, using a cross sectional study of patients registered in a CPRD Aurum practice on 1st July 2019, this study will describe use of blood pressure lowering and lipid lowering medications on the study date, stratified by individual cardiovascular disease risk factors and predicted ten year risk of cardiovascular disease. Univariate logistic regression models will be used to determine the crude association of each risk factor with prescriptions. We will investigate whether prescribing is guideline compliant and assess inequalities by age, sex, ethnicity and socioeconomic status.Analyses will be repeated in 2020 and 2021 to examine the impact of the pandemic on prescribing.
These analyses will determine whether the right patients are receiving treatment. This CPRD study will be compared to similar analyses using data from New Zealand. The UK and New Zealand provide a useful comparison in settings due to their disparate blood pressure but similar lipid lowering guidelines. These analyses will enable us to understand whether GPs tend to use risk to guide treatment decisions, and to what extent differences in guidance influence treatment decisions.
Source -
Trends in remote GP consultations and the impact of remote consultations on antibiotic prescribing of antibiotics pre- and during COVID - an observational study — Emma Vestesson ...
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Trends in remote GP consultations and the impact of remote consultations on antibiotic prescribing of antibiotics pre- and during COVID - an observational study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-27
Organisations:
Emma Vestesson - Chief Investigator - The Health Foundation
Emma Vestesson - Corresponding Applicant - The Health Foundation
Alison Dias - Collaborator - NHS England
Caroline Fraser - Collaborator - The Health Foundation
Elizabeth Crellin - Collaborator - The Health Foundation
Geraldine Clarke - Collaborator - The Health Foundation
Kaat De Corte - Collaborator - The Health Foundation
Xiaochen GE - Collaborator - NHS EnglandOutcomes:
Outcomes of interest will be derived from CPRD and include:
⢠Consultation mode (remote compared to face-to-face) over time
⢠Consultation mode by diagnosis code, sex, age, patient level index of multiple deprivation, and Rural-Urban Classification
⢠Consultations for ARIs and UTIs that resulted in antibiotics being prescribedDescription: Technical Summary
The aim of this project is to define and study the use of remote consultations in primary care in England from 2018 up to and throughout the COVID-19 affected period, and to assess the impact of remote consultation on antibiotic prescribing. We intend to use data from CPRD Aurum linked to the index of multiple deprivation (IMD) at the patient level and the Rural-Urban Classification (RUC) at the practice level.
We will classify the mode of each consultation as either remote or face-to-face. To describe trends in remote consultations we will calculate the proportion of remote consultations, and the rate of remote consultations per 1000 consultations and per 1000 registered patient days on a weekly basis. This will also be done broken down by age, sex, patient level IMD, and practice level RUC monthly.
We will describe what type of patients (age, sex etc) are using remote vs. face-to-face consultations before and during the pandemic and what they are using primary care for according to the consultation diagnosis codes.We will use multivariable logistic regression to test the association between consultation mode and antibiotic prescribing. We will restrict this analysis to consultations with a diagnosis code of acute respiratory infections (ARIs) and/or urinary tract infections (UTIs). These are among the most common causes for antibiotics prescribing in primary care and were commonly dealt with through remote consultations even before the pandemic. Models will adjust for i) sex and age, ii) indicators of need for health care (number of long-term conditions, combination of conditions), and iii) indicators of social need.
We will estimate the effect of remote appointments on antibiotic prescribing before and during the pandemic separately.
Understanding remote GP consultation patterns and the impact of remote consultations on antibiotic prescribing will help inform how primary care should be structured post-COVID.
Source -
Cost-effectiveness of osteoporotic fracture risk assessment in people with intellectual disabilities — Valeria Frighi ...
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Cost-effectiveness of osteoporotic fracture risk assessment in people with intellectual disabilities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-08
Organisations:
Valeria Frighi - Chief Investigator - University of Oxford
Valeria Frighi - Corresponding Applicant - University of Oxford
Felix Achana - Collaborator - University of Oxford
Gary Collins - Collaborator - University of Oxford
Jan Blair - Collaborator - Dimensions (UK) Ltd
Margaret Smith - Collaborator - University of Oxford
May Ee Png - Collaborator - University of Oxford
Stavros Petrou - Collaborator - University of Oxford
Tim Holt - Collaborator - University of Oxford
Timothy Andrews - Collaborator - Oxford Health NHS Foundation TrustOutcomes:
Major osteoporotic fracture, hip fracture within 10-years of index date.
Cost-effectiveness of each of the following strategies to estimate risk of MOP and of hip fracture
⢠Current strategy as recommended by the National Institute for Health and Care Excellence (NICE) using QFracture for risk score calculation (1-3)
⢠Risk assessment by IDFracture (4) in all patients from age 40 years, with bone mineral density scan (DXA) in those in the region of an intervention threshold (1, 5)
⢠To perform DXA in all patients from age 40Description: Technical Summary
Unpublished results from our previous study (ISAC Protocol 18_186R) in CPRD Gold linked to HES show higher incidence of major osteoporotic (MOP) fractures (vertebra, shoulder, wrist, hip) and of hip fracture in adults with intellectual disabilities [ID] (n= 27706) compared to age and sex matched adults without ID (n= 139033).
We found that the current fracture risk calculator (QFracture) underestimated risk in ID patients.
We developed a risk score (IDFracture) estimating the 10-year risk of MOP and of hip fracture for ID adults 30-79 years old.
Aims
Validate IDFracture in the Aurum database
Determine the most cost-effective risk assessment method for MOP and for hip fractures in ID adults
Objective
Inform policy for osteoporotic fracture risk assessment
Outcomes
Incidence of MOP and of hip fracture within 10-years of the index date
Cost-effectiveness of 3 different strategies to determine risk of MOP and of hip fracture
Methods
Validation of IDFracture risk scores in the Aurum database with full linkage to HES and IMD datasets (to ensure complete capture of events and covariates).
For cost-effectiveness analyses we will use the subset aged 40-79 years.
We will use a Markov model with an annual transition cycle projecting life-long incidence of fractures and death. The model will be run assuming three strategies:⢠Current strategy, using QFracture for risk calculation
⢠Risk assessment by IDFracture in all patients from age 40 years, with bone mineral density scan (DXA) in those in the region of an intervention threshold.
⢠DXA in all patients from age 40 (follow up according to result)For each strategy, total lifetime costs and outcomes plus incremental cost-effectiveness ratio (ICER) will be calculated against the next most effective strategy. Main analyses will be done from NHS perspective. Impact of fracture on health-related quality of life will be taken from the literature.
Source -
Optimal dynamic treatment regimes for the management of chronic obstructive pulmonary disease (COPD) — Samy Suissa ...
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Optimal dynamic treatment regimes for the management of chronic obstructive pulmonary disease (COPD)
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Michael Wallace - Collaborator - University Of Waterloo
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Moderate and/or severe exacerbation of COPD (prescription for an oral corticosteroid (prednisolone) and/or hospitalization with a primary diagnosis of COPD); hospitalization for community-acquired pneumonia.
Description: Technical Summary
Chronic obstructive pulmonary disease (COPD) has become the third leading cause of death worldwide. Long-acting beta2-agonists (LABAs), long-acting muscarinic antagonists (LAMAs) and inhaled corticosteroids (ICS) are central pharmacologic therapies for COPD. ICS are associated with some known risks, including pneumonia, while their effectiveness appears to vary with different patient characteristics, including blood eosinophil counts, asthma, frequent exacerbations and smoking. We propose to determine the optimal initial and subsequent treatment strategy for COPD, balancing effectiveness and risk, according to specific patient characteristics.
We will use a large cohort of patients newly treated for COPD to uncover patient characteristics of differential effects of treatment on the incidence of COPD exacerbations and pneumonia. The cohort, extracted from the CPRD, will include new users of LAMA, LABA or LABA-ICS inhalers during 2002-2018, age 40 or over, followed for two years for the endpoints of COPD exacerbation and pneumonia. It is estimated to include over 150,000 subjects. We will conduct a two-stage dynamic treatment regime (DTR) analysis, using the recursive approach to dynamic weighted survival modelling, to determine patient-treatment profiles that maximize the time to the second COPD exacerbation and to severe pneumonia. At each stage, propensity scores will be used to weigh the analyses by inverse probability of treatment and of censoring. The DTR analysis will estimate blip functions on several tailoring covariates, namely blood eosinophils, smoking, sex, exacerbation history, asthma diagnosis, as well as age, obesity and dyspnea severity.
This large study in a real world setting of the treatment of COPD, using the dynamic treatment regime approach, will provide a precision medicine algorithm to optimize COPD management. By using patient characteristics routinely measured in the typical clinical setting, clinicians will be able to choose optimal treatments according to clinical profiles that increase the effectiveness and reduce the risk of treatment.
Source -
Event Rates and Risk Factors for Cardiovascular Events in a Population with an Acute Coronary Syndrome Hospitalization in the United Kingdom — Pia Horvat ...
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Event Rates and Risk Factors for Cardiovascular Events in a Population with an Acute Coronary Syndrome Hospitalization in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-27
Organisations:
Pia Horvat - Chief Investigator - IQVIA Ltd
Nelly Ly - Corresponding Applicant - IQVIA Ltd
Alexandra Koumas - Collaborator - Axtria Inc. USA
Ankita Chauhan - Collaborator - Axtria Inc. USA
Anna Castelo Branco - Collaborator - IMS Health Sweden AB
Aurore Tricotel - Collaborator - IQVIA Operations France SAS
Christian Siegfried - Collaborator - Axtria Inc. USA
Christopher Lee - Collaborator - IQVIA Ltd
Emil Vatov - Collaborator - IQVIA Solution Bulgaria EOOD
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Jessica Lundbom - Collaborator - IQVIA Ltd
Louise Raiteri - Collaborator - IQVIA Ltd
Nelly Ly - Collaborator - IQVIA Ltd
Nicole Rutishauser - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Oriane BRETIN - Collaborator - IQVIA Operations France SAS
Quratul Ann - Collaborator - IQVIA Ltd
Sophia Rodopoulou - Collaborator - IQVIA Hellas Technology Solutions S.A.
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Sushant Pal - Collaborator - Axtria India Pvt. Ltd.
Tarana Mehdikhanova - Collaborator - IQVIA Ltd
Vanessa Marzola - Collaborator - IMS Health Sweden ABOutcomes:
Primary outcomes will be defined as the composite of nonfatal myocardial infarction (MI), nonfatal ischemic stroke, and cardiovascular (CV) death.
Secondary outcomes will be defined as nonfatal MI, nonfatal ischemic stroke, CV death, unstable angina hospitalization, and elective coronary revascularization as a composite outcome and separately, and all-cause mortality.
Descriptive variables during the follow-up will be lipid lowering therapies (LTT) (including statins, ezetimibe, and PCSK9 inhibitors) and achieved low-density lipoprotein cholesterol (LDL-C) levels.Description: Technical Summary
The planned study design is a longitudinal retrospective observational cohort study based on a population with an acute coronary syndrome (ACS) hospitalization determined from Hospital Episode Statistics (HES) database in the United Kingdom. This database as well as the Clinical Practice Research Datalink (CPRD) database will be utilized for baseline characteristics such as laboratory measures or comorbidities. CPRD database will be utilized to study treatment patterns and achieved low-density lipoprotein cholesterol (LDL-C) over time, and HES and Office for National Statistics (ONS) databases to follow up the study outcomes. Primary objective and first secondary objective will describe event rates over time for the primary and secondary outcomes (cardiovascular (CV) events) via Kaplan-Meier analyses. Possible risk factors for the primary and secondary outcomes will be assessed via a Cox proportional hazards model and will include patient demographics, clinical characteristics, laboratory measures, lifestyle, and medication characteristics. Summary statistics of these variables will be provided as part of the second secondary objective. To address the last secondary objective, proportion of patients on various therapies, proportion of patients within categories of achieved LDL-C, rates of all possible treatment-related events including treatment initiation, intensification, discontinuation, and re-start, and LDL-C levels will be described. Analyses will be provided for the whole study population and separately for each subgroup of interest (CV risk score at index, index ACS type, treatment with revascularization for index ACS, evidence for diabetes mellitus prior to index, evidence for coronary heart disease prior to index ACS, evidence for ischemic cerebrovascular disease prior to index ACS, evidence for peripheral arterial disease prior to index ACS, and evidence for ACS events within 12 months prior to index ACS).
Source -
Epidemiology of gout, its treatment and comorbidities - a prospective cohort study using data from Clinical Practice Research Datalink (CPRD) — Abhishek Abhishek ...
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Epidemiology of gout, its treatment and comorbidities - a prospective cohort study using data from Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-06-09
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
dalia Elmelegy - Corresponding Applicant - Nottingham University Hospitals
Anthony Avery - Collaborator - University of Nottingham
Georgina Nakafero - Collaborator - University of Nottingham
Laila Tata - Collaborator - University of Nottingham
Mamas Mamas - Collaborator - Keele UniversityOutcomes:
⢠Gout â incident and prevalent
⢠Urate lowering treatment prescription
⢠Urate lowering treatment achieving serum urate treatment target (serum urate less than 300 micromol/L)
⢠Death
⢠Acute myocardial infarction
⢠Acute stroke
⢠Venous thromboembolism â defined as either deep vein thrombosis or pulmonary embolism,Description: Technical Summary
Objectives: [1] To examine the temporal trend in incidence and prevalence of gout between 1997-2021. [2] To examine the temporal trend in all-cause mortality and prevalence of urate lowering treatment (ULT) prescription, ULT prescription achieving serum urate treatment target, in patients with gout between 1997-2021. [2] To examine the association between gout flares and (a) acute myocardial infarction, (b) stroke, (c) venous thromboembolism.
Design: prospective cohort study with nested cross-sectional and case-control studies.
Study period: 01/01/1997â 30/09/2021.
Data sources: Clinical Practice Research Datalink, Hospital Episode Statistics, Office for National Statistics
Methods: We will calculate the point prevalence of gout, and ULT prescription in people with gout on the 1st July of each year between 1997 and 2021. Participants in receipt of ULT prescription(s) in the 60 days preceding the 1st of July will be classified as prescribed ULT. The latest serum urate before 1st July of each year will be used to define whether the serum urate is below treatment target or not for those on ULT. Similarly, annual incidence of gout between 1997 and 2021, and mortality rate of gout cases incident in each calendar year between 1997 and 2021 will be calculated. Join Point regression will be used to examine the temporal trends. The association between acute myocardial infarction, stroke, venous thromboembolism, and gout will be assessed using nested case-control study design. The nested case-control study will include controls that are age, sex and duration of registration in CPRD matched to cases, and adjusted for covariates including demographic factors, lifestyle factors, ULT, and comorbidities. Three nested case control studies will be performed, one for each outcome of interest. Conditional logistic regression will be used to examine associations. Adjusted OR, and 95% confidence intervals (CIs) will be calculated. Data management and analysis will be performed by STATA version 16.
Source -
ID-136: Local-level analysis for the REAL Centre second annual report — Midlands and Lancashire CSU (MLCSU)...
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ID-136: Local-level analysis for the REAL Centre second annual report
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-21
Opt Outs: no information provided./p>
Organisations: Midlands and Lancashire CSU (MLCSU)
Description: North West London. Commercial
Source -
ID-137: Extension Request: Personalised care analysis à phase two — University College London...
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ID-137: Extension Request: Personalised care analysis à phase two
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-21
Opt Outs: no information provided./p>
Organisations: University College London
Description: Patient Activation Measure. Commercial
Source -
ID-134: Extension Request: Evaluation of the Effectiveness of the Integrated Business Case intervention in Hillingdon — Brunel University London...
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ID-134: Extension Request: Evaluation of the Effectiveness of the Integrated Business Case intervention in Hillingdon
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-21
Opt Outs: no information provided./p>
Organisations: Brunel University London
Description: Hillingdon. Commercial
Source -
ID-135: Estimating inequalities in unmet clinical need in patients with cardiovascular disease — Lane Clark & Peacock LLP...
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ID-135: Estimating inequalities in unmet clinical need in patients with cardiovascular disease
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-21
Opt Outs: no information provided./p>
Organisations: Lane Clark & Peacock LLP
Description: Cardiovascular Disease. Commercial
Source
2021 - 05
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Education Policy and Youth Crime in England — unknown...
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Education Policy and Youth Crime in England
Where: unstated
When: 2021-5-19
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The Education Policy and Youth Crime in England (EPYCE) project is an initiative led by researchers at the London School of Economics (LSE), and funded by ADR UK, to use linked administrative data to improve understanding of the relationship between education policy and youth crime.
This unique dataset will link English school and crime records from 2002, making it the largest dataset of its kind to contain education and crime records for young people. Crime and education experts aim to use the data to investigate what, if any, impact education policy initiatives have had on the levels and nature of crime committed and experienced by young people in England.
The projectThe project will involve three steps:
Understanding the impact of the introduction of the Literacy and Numeracy Hour programmes in the late 1990s on youth crime and permanent exclusion from school. Literacy and Numeracy Hour programmes were rolled out nationally to all English schools through the National Literacy and Numeracy Strategies (NLS and NNS). These initiatives aimed to raise the standards of English teaching and to improve the literacy and numeracy standards of primary school children. Analysing the impact of the recent school leaving age reforms on youth crime in England. Since the early 1970s, the school leaving age in England was 16 until it was raised to 17 in 2013 and 18 in 2015. Currently, English children must stay in school until age 16, upon which they can either enrol in vocational training, an apprenticeship or remain in school until age 18. A novel feature of these reforms is they were not implemented at the same time across England. This project will exploit this variation to study the impact of these reforms on youth crime. Examining the impact of secondary school attendance on the day-to-day opportunity and desire to commit crime. Schools have the power to independently decide when to hold a teacher training (INSET) day, meaning natural variation exists between schools and across years in the dates when children and young people are allowed to stay home from school. Data will be collected on INSET dates for all secondary schools in England to examine whether young people are more likely to commit crime when schooling is off. This will allow us to understand whether just a few days off from school can influence the risk of committing crime, and therefore whether policy should intervene accordingly. What is the potential of this newly linked data?The focus of this project is on the potential crime-reducing role of education policy and public education providers. The project will provide rigorous empirical evidence of the impact of recent UK education policy on youth crime for all young people in England. Therefore, no particular groups of young people will constitute the focus of this analysis, nor be identified as individuals at risk by either the public or the police.
The project team is working closely with the Greater Manchester Police to ensure findings are as relevant and useful as possible to policymakers, police forces and other service delivery professionals focusing on increased crime rates over the last five years. The aim of this project is to help inform policies and initiatives that reduce the likelihood of young people either becoming involved in crime or being victims of crime, and to reduce the impact of youth crime on individuals, families and communities.
Project detailsProject lead: Dr Matteo Sandi, LSE
Duration: April 2021 â June 2022
Funding: £147,902
This project is funded via the ADR England Fund, a dedicated fund for commissioning research using newly linked administrative data.
Source -
Demographics (Identifiable) (Secondary Uses) — Department of Health and Social Care...
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To provide address details for individuals who have requested a Covid vaccination statement of status letter. — IG-02773
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 17/05/2021
Purpose for which the data is being used: To provide address details for individuals who have requested a Covid vaccination statement of status letter.
Dataset: Demographics
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Demographics, Vaccination Data and SPL Data (Record level and aggregate (no small number suppression)) (Direct Care and secondary uses) — NHS England...
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The GP Vaccines Dashboard seeks to provide visibility of current Covid vaccine uptake for a GPâs registered patients, wherever the vaccine was administered, to support and enable action of individual patient care and thus the community. The dashboard will report on the local vaccine uptake and provide data for all vaccine activity for a patient regardless of point of care system. — IG-02635
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 07/05/2021
Purpose for which the data is being used: The GP Vaccines Dashboard seeks to provide visibility of current Covid vaccine uptake for a GPâs registered patients, wherever the vaccine was administered, to support and enable action of individual patient care and thus the community. The dashboard will report on the local vaccine uptake and provide data for all vaccine activity for a patient regardless of point of care system.
Dataset: Demographics, Vaccination Data and SPL Data
Category of Data: Record level and aggregate (no small number suppression)
Direct Care or Secondary Uses : Direct Care and secondary uses
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - legal obligation GDPR Article 9(2)(g) - substantial public interest, plus DPA18 Part 2 Schedule 1 para 6 - statutory and governmental purpose
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - legal obligation GDPR Article 9(2)(g) - substantial public interest, plus DPA18 Part 2 Schedule 1 para 6 - statutory and governmental purpose
National Data Opt-out Applied: Not applied - legal obligation overrides.
Source -
SPL data and Vaccines Group 6 data (Aggregate (small numbers not suppressed)) (Secondary uses) — Department of Health and Social Care...
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DHSC would like to understand the size of the risk population for covid vaccinations to ensure they have reliable estimates, but the main purpose is to ensure they have the best estimates available for vaccine deployment, planning and evaluation â now and in the future — IG-03989
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 09/05/2021
Purpose for which the data is being used: DHSC would like to understand the size of the risk population for covid vaccinations to ensure they have reliable estimates, but the main purpose is to ensure they have the best estimates available for vaccine deployment, planning and evaluation â now and in the future
Dataset: SPL data and Vaccines Group 6 data
Category of Data: Aggregate (small numbers not suppressed)
Direct Care or Secondary Uses : Secondary uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR
National Data Opt-out Applied: Not Applied - the data is not patient identifiable.
Source -
Demographics (Identifiable) (Direct Care) — NHS England...
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The purpose is to identify unpaid carers who are eligible for the COVID-19 booster vaccination. — IG-1889_7
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 10/05/2021
Purpose for which the data is being used: The purpose is to identify unpaid carers who are eligible for the COVID-19 booster vaccination.
Dataset: Demographics
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: Legal Obligation - Covid-19 Direction to disseminate
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 6(1)(e) - public task GDPR Article 9(2)(g) - substantial public interest, plus DPA 2018 Part 2 Schedule 1 para 6 - statutory and governmental purpose
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: Legal Obligation - Covid-19 Direction to disseminate
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 6(1)(e) - public task GDPR Article 9(2)(g) - substantial public interest, plus DPA 2018 Part 2 Schedule 1 para 6 - statutory and governmental purpose
National Data Opt-out Applied: Not Applied - Direct Care
Source -
PDS fields
- Language inc Braille
- Written communication Format (Identifiable) (Direct Care) — NHS England...
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The data dissemination will flow two additional data items from the Personal Demographic Service (PDS) to the National Immunisation Management System, for the purposes of Covid-19 vaccination call/re-call, to ensure all future communications adhere to the Accessible Information Standard (DCB1605). — IG-03202
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 07/05/2021
Purpose for which the data is being used: The data dissemination will flow two additional data items from the Personal Demographic Service (PDS) to the National Immunisation Management System, for the purposes of Covid-19 vaccination call/re-call, to ensure all future communications adhere to the Accessible Information Standard (DCB1605).
Dataset: PDS fields - Language inc Braille - Written communication Format
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) â substantial public interest, plus Part 2 Sched 1 DPA18, para 6 statutory and governmental purpose GDPR Article 9(2)(h) â healthcare purposes, plus Part 1 Sched 1 DPA18, para 2 health or social care purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) â substantial public interest, plus Part 2 Sched 1 DPA18, para 6 statutory and governmental purpose GDPR Article 9(2)(h) â healthcare purposes, plus Part 1 Sched 1 DPA18, para 2 health or social care purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
National Data Opt-out Applied: Not Applied - Direct Care and Legal obligation overrides.
Source -
The Prescribing of Analgesia and Predictors of Long-Term Analgesia Prescriptions in Patients with Inflammatory Arthritis: An Observational Study using the Clinical Practice Research Datalink. — Ian Scott ...
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The Prescribing of Analgesia and Predictors of Long-Term Analgesia Prescriptions in Patients with Inflammatory Arthritis: An Observational Study using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-03
Organisations:
Ian Scott - Chief Investigator - Keele University
Ian Scott - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Helen Twohig - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Samantha Hider - Collaborator - Keele University
Sara Muller - Collaborator - Keele UniversityOutcomes:
STUDY 1
Methods to establish the diagnosis of RA, PsA, and axial SpA in CPRD Aurum.STUDY 2
Analgesia prescriptions for patients with inflammatory arthritis.STUDY 3
Time to receipt of a long-term opioid, oral NSAID, or gabapentinoid prescription following a diagnosis of inflammatory arthritis.Description: Technical Summary
BACKGROUND
Inflammatory arthritis groups diseases involving immune-driven joint inflammation. Its three main forms â rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axial SpA) â affect 1-2% of UK adults.Pain is a major problem for patients with inflammatory arthritis and is the symptom they most want improving. International data suggest inflammatory arthritis pain management overuses long-term analgesia, despite their relative inefficacy/risks. The extent to which this occurs in England is uncertain. Our study will address this knowledge-gap.
AIM
To describe analgesia prescribing in patients with inflammatory arthritis managed in the English NHS, and identify risk factors for receiving long-term analgesia prescriptions.OBJECTIVES
To undertake the following in patients with inflammatory arthritis (RA, PsA, axial SpA) using CPRD Aurum:1. Develop a method to determine patients diagnosed with inflammatory arthritis in English primary-care records.
2. Describe the annual prevalence of analgesia prescriptions amongst patients with diagnosed inflammatory arthritis, and how this differs: (a) by patient/arthritis characteristics; (b) geographically; (c) over time.
3. Define their risk factors for receiving long-term analgesia prescriptions.
METHODS
Study 1: iterative meetings will develop SNOMED/Read code lists with/without algorithms to determine patients diagnosed with inflammatory arthritis; cross-sectional analyses will establish if these determine patient groups with expected characteristics (e.g. receiving immunosuppression).Study 2: cross-sectional analyses will describe the annual prevalence of analgesia prescriptions in patients with inflammatory arthritis from 2004-2020. This will be stratified by analgesia-type (e.g. opioid/NSAID), patient/arthritis characteristics (age, gender, ethnicity, English Index of Multiple Deprivation quintiles [where available], arthritis duration/subtypes), geographical region. Joinpoint regression will examine changes in time-trends of analgesia prescription prevalence.
Study 3: a retrospective cohort study using Cox proportional hazards models will test the association between risk factors at arthritis diagnosis (e.g. depression diagnosis) and the outcome of time to receiving a long-term opioid, oral NSAID, or gabapentinoid prescription.
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Incidence and prevalence of mental illness in pregnancy and the first five years after giving birth: a retrospective cohort study using electronic primary care data — Rebecca Taylor ...
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Incidence and prevalence of mental illness in pregnancy and the first five years after giving birth: a retrospective cohort study using electronic primary care data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-06
Organisations:
Rebecca Taylor - Chief Investigator - University of Birmingham
Jamie-Rae Tanner - Corresponding Applicant - St Helens & Knowsley NHS Trust
Eleanor JONES - Collaborator - University of Birmingham
Lauren Carson - Collaborator - University of BirminghamOutcomes:
Incidence rate of mental health disorder in pregnancy and each of the first five years after giving birth.
Description: Technical Summary
This is a retrospective cohort study of women's post-partum mental health diagnoses using CPRD pregnancy register data and GP practice READ codes for mental health problems in the 5 years after birth. This will be identified through either a prescription for medications associated with mental health diagnoses identified, and/or a diagnosis of a mental health condition within the pregnant and 5 year post-partum period. The list of included codes were created in conjunction with academic clinicians and secondary care physicians who are specialists in perinatal mental health disorders. This will allow us to inform the debate about if a newly proposed two year postpartum âcut-offâ for access to Perinatal Mental Health (PMH) services is sufficient.
Maternal demographic, clinical and sociodemographic factors will be summarised. For categorical variables, counts and percentages will be reported. For numeric variables means and standard deviations or medians and interquartile ranges will be reported, where appropriate.
For our primary outcome (incidence of maternal mental health disorders in pregnancy and the 5 years postpartum), all analysis will be conducted at an aggregate level and monthly variation in the data will be assessed to explore any effect of seasonality.Multilevel logistic regression models, clustered by maternal delivery episode, will be fitted to investigate predictors of maternal morbidity and mortality among women from different minority backgrounds. Regression models will be adjusted to account for maternal socio-demographic characteristics and pre-existing medical co-morbidity.
Logistic regression (at cohort entry) and cox regression models will be fitted to identify the rate of maternal mental health disorders at entry and to the subsequent prediction of risk of developing a mental health disorder during the study period (pregnancy through until 5 years post-partum). Both models will be adjusted to account for maternal sociodemographic characteristics, pre-existing medical co-morbidity and neonatal outcomes.
Source -
Prevalence, Incidence, and healthcare burden of generalised pustular psoriasis, palmoplantar pustulosis, and plaque psoriasis in England — Smit Patel ...
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Prevalence, Incidence, and healthcare burden of generalised pustular psoriasis, palmoplantar pustulosis, and plaque psoriasis in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-26
Organisations:
Smit Patel - Chief Investigator - Boehringer-Ingelheim International GmbH
Smit Patel - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Christopher Griffiths - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
richard warren - Collaborator - University of ManchesterOutcomes:
Primary outcomes
Prevalent cases and rate of GPP,PPP, and PV; Incident cases and rate of GPP,PPP, and PV
Secondary Outcomes:
Number of prior hospitalisations; Mortality rate (By 5-year age group and sex; directly standardised to 2019 1st July CPRD general population); healthcare utilisation: number/NHS cost of A&E visits, outpatient visits, inpatient admissions, and general practitioner (GP) visits
Exploratory Outcomes:
Number and cost of psoriasis prescriptions/treatments
Psoriasis Area Severity Index (PASI) scoresIncidence, prevalence, and mortality of GPP,PPP, and PV patients will be stratified by 5-year age groups and sex; directly standardised to 2019 1st July CPRD general population):
Description: Technical Summary
Generalised pustular psoriasis (GPP) and palmoplantar pustulosis (PPP) are two sub-classifications of pustular psoriasis. GPP is characterised by rapidly progressing diffuse erythematous patches with pustules that coalesce to form lakes of pus. Patients with GPP may experience flares which can lead to serious complications such as sepsis, and even death. In PPP, pustules are restricted to the palms of hands and soles of feet. Both GPP and PPP can occur independently of a history of psoriasis.
This retrospective descriptive cohort study will utilise primary electronic health records linked to Hospital Episodes Statistics (HES) and Office of National Statistics (ONS) datasets to quantify prevalence, incidence, mortality, and resource utilisation of GPP and PPP compared to the more commonly diagnosed psoriasis vulgaris (PV).
The primary objectives of this study include the estimation of prevalence, incidence, and patient characteristics of GPP, PPP, and PV between 1st January 2008 and 31st December 2019. The secondary objectives will estimate the all-cause mortality for each cohort using Kaplan-Maier analysis during this time period and recent healthcare resource utilisation (HCRU) during 1st January 2015 to 31st December 2019.
Patient characteristics and HCRU will be stratified by prevalent and incident cases and by patient cohort. categorical variables will be tabulated with frequencies and percentages whereas the mean/standard deviation or will be used to describe continuous variables. Prevalence, incidence, and mortality will be directly standardised by age and sex from 01st January 2008 to 31st December 2019. These rates will also be presented using negative binomial Poisson regression adjusted for age and sex.
The study design has been chosen as it is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for procedures, demographics, costs, complications, readmissions and resource use.
Source -
Impact of underlying diseases, diagnostic processes and treatment on heart failure disease trajectory using international data — Chris Gale ...
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Impact of underlying diseases, diagnostic processes and treatment on heart failure disease trajectory using international data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-05
Organisations:
Chris Gale - Chief Investigator - University of Leeds
Kazuhiro Nakao - Corresponding Applicant - University of Leeds
Jianhua Wu - Collaborator - University of Leeds
Ramesh Nadarajah - Collaborator - University of Leeds
Yoko Nakao - Collaborator - University of LeedsOutcomes:
The primary outcomes of this study will be new-onset HF, hospital admission for HF, and all-cause mortality. The secondary outcomes will include guideline-directed care implementation rate ratios and subsequent diagnosis of HF (post-index HF diagnosis).
Description: Technical Summary
To prevent or delay the development of Heart Failure (HF), it is essential to understand the trajectory of HF and provide appropriate interventions at each step to slow progression. However, current treatment for HF is inadequate, and it is unclear whether treating the patientâs HF is sufficient. Hence, the association between variabilities in treatment and patient outcome must be further studied. Moreover, limited information is available for predicting the development of new-onset HF in patients undergoing treatment for underlying diseases, and the effectiveness of treatment of HF-associated comorbidities in clinical practice is unclear.
Therefore, this study aims to investigate clinical pathways in patients with HF and the effects of therapeutic interventions on disease trajectory using electronic, national hospital-linked primary healthcare databases and compare the results with Japanese datasets.Specifically, the study will: To use international data,
1. To understand the mode of disease development for HF
2. To investigate the onset of the new disease following HF diagnosis using international data
3. To quantify HF a quality of care according to national and international guidelines, and its association of outcomes.The primary outcomes of this study will be new-onset HF, hospital admission for HF, and all-cause mortality. We will obtain mortality, social deprivation indices and patient outcome from ONS, IMD and HES Admitted Patient Care dataset. We will use a deep machine learning model and process mining techniques to predict onset of HF and determine the disease trajectory after the diagnosis of HF. We will use Cox proportional hazards regression to assess the association between process performance measures and outcomes.
Investigating the trends and clinical pathways of HF patients and their management will help reduce mortality by targeting specific patient groups for therapy. In addition, determining the predictive factors for new-onset HF helps target high-risk individuals to initiate preventive measures.
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Maternal prescriptive drug use: the risks and benefits to mothers and neonates — Neil Davies ...
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Maternal prescriptive drug use: the risks and benefits to mothers and neonates
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-12
Organisations:
Neil Davies - Chief Investigator - University of Bristol
Ciarrah-Jane Barry - Corresponding Applicant - University of Bristol
Dheeraj Rai - Collaborator - University of Bristol
Florence Martin - Collaborator - University of Bristol
Gemma Sharp - Collaborator - University of Bristol
Harriet Forbes - Collaborator - University of Bristol
Kayleigh Easey - Collaborator - University of Bristol
Paul Madley-Dowd - Collaborator - University of Bristol
Venexia Walker - Collaborator - University of BristolOutcomes:
Outcomes to be measured
Maternal outcomes, depression: Incidence of depression during pregnancy; severity of depression during pregnancy
Maternal outcomes, diabetes: Gestational diabetes; episodes of hypo- or hyper-glycaemia
Maternal outcomes, hypertension: Hypertensive disorders of pregnancy
Maternal outcomes, thyroid related: Common symptoms of thyroid malfunction; episodes of thyroid malfunction
Maternal outcomes, all four conditions investigated: Mode of delivery; post-partum haemorrhage; post-partum all-cause hospitalisationNeonatal outcomes, : stillbirth (delivery at â¥24 weeks with an Apgar score of 0,0,0); miscarriage (foetal loss <24 weeks); elective termination of pregnancy; birthweight; birthweight for gestational age; birth length; head circumference; gestational age (preterm delivery <37 weeks); impaired growth; Apgar score <7 at 1, 5, 15 minutes; congenital defects.
Childhood outcomes: autism spectrum disorder (ASD); attention deficit hyperactivity disorder (ADHD); intellectual disability (ID) in childhood.
Description: Technical Summary
It is increasingly common for pregnant women to be prescribed medication for chronic conditions. Depression and antidepressant use are increasingly common in women of a child-bearing age, with studies suggesting that up to 20% of pregnant women suffer from depression during pregnancy [1]. In addition, cardiovascular related conditions are relatively common, with 15% of pregnant women experiencing hypertension. Although less common, endocrine conditions, such as diabetes and thyroid disorders, are persistent and problematic within pregnancy, affecting around 4% and 10% of pregnant women respectively [2, 3].
These conditions are well-established risk factors for numerous adverse maternal and neonatal such as preeclampsia, stroke, and preterm birth if left untreated. Yet, treatments for these conditions are associated with additional neonatal risks, with many studies finding evidence of teratogenic effects. There is also conflicting evidence surrounding potential adverse neurodevelopmental outcomes following exposure to antidepressants in utero [4]. With limited pharmacoepidemiological data to support their effects in human populations, information to make clinical recommendations during pregnancy is limited.
The aims for this study are to determine whether medication prescribed for depression, diabetes, hypertension and thyroid disordered are associated with (1) maternal risk, (2) neonatal risk and (3) offspring risk. We will address the first of these aims by conducting an observational cohort study to investigate the relationship between prescribed medications for these conditions in pregnancy with maternal outcomes. Then, we will utilise the same approach to analyse neonatal risk following use of these medications in pregnancy. Thirdly, we will address offspring risk by analysing treatment use during pregnancy to determine the effects of the drug exposures on long-term childhood outcomes. Together, these findings will enhance available knowledge of maternal prescriptive drug use, enabling more informed clinical decisions to be made in the future.
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Antidementia drugs use in patients with Alzheimer's disease — Wenjun zhong ...
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Antidementia drugs use in patients with Alzheimer's disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-12
Organisations:
Wenjun zhong - Chief Investigator - Merck & Co., Inc.
Wenjun zhong - Corresponding Applicant - Merck & Co., Inc.
Xinyue Liu - Collaborator - Merck & Co., Inc.Outcomes:
For each line of therapy, we will describe the drug names, route (pill or patch), dose, time to start, time to switch, and time to discontinuation.
The outcomes are the percentages of each therapy among the first three lines of therapies. We will report time to start, time to discontinue, time to switch for each line of therapy.
We will also report the percentage of patients on antidementia therapy (and percentages on first/second/third line of therapy) at 6-month, 12-month, 18-month, 24-month follow-up.
Description: Technical Summary
Study objective: To describe antidementia drugs use in newly diagnosed AD patients in the CPRD database.
study design: this is a descriptive study without hypothesis testing. Patients who were newly diagnosed with AD in 2018-2019 will be followed up on their antidementia treatments for at least one year. The antidementia treatment during the follow-up time period after AD diagnosis will be described, including the drug names (donepezil, rivastigmine, galantamine, memantine), percentages of exposure, route, dose (initial dose, titrated dose), duration (time to start and time to switch/discontinuation). If a patient receives more than one anti-dementia drug within a 21-day window from the start of a line of therapy, the patient is determined to be using combination therapy in that line of therapy. Once a patient has started a new drug (outside of the initial 21-day window), we determine that the patient has moved to the subsequent line of therapy. In later lines of therapy, a patient is also determined to be using combination therapy if the patient receives a new drug while the preceding drug is still ongoing (the patient added the new drug to their current therapy). We will require the patients to have a second fill of both components to be qualified as combination therapy. If, however, the previous agent is not continued once a new agent is started, the patient is determined to have switched therapies. The drug discontinuation is defined as the no refill of the drug in 8 weeks after the days of supply.
Statistical methods: Antidementia drugs used in newly diagnosed AD patients will be described by their names, route, and dose. The duration of treatment will be described by Kaplan-Meier methods, and the outcome will be switching to the second line, discontinuation of the first line without switching, disenrollment, or end of study.
Source -
Real-World Effectiveness of Denosumab in Prevention of Fracture among Postmenopausal Osteoporotic Women with FREEDOM Baseline Characteristics — Daniel Prieto...
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Real-World Effectiveness of Denosumab in Prevention of Fracture among Postmenopausal Osteoporotic Women with FREEDOM Baseline Characteristics
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-19
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Victoria Y Strauss - Corresponding Applicant - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Joe Maskell - Collaborator - Amgen LtdOutcomes:
Non-vertebral fracture (incl. hip fractures); overall fracture; clinical vertebral fracture; hip fracture
Description: Technical Summary
OBJECTIVES:
This study will aim to assess whether available analytical methods could obtain comparable findings to those from the FREEDOM Randomized Clinical Trial (RCT) in primary care real world data (RWD) using CPRD. For each method, we will specifically analyze the association between denosumab use (compared to no anti-osteoporosis drug therapy) and fracture risk amongst postmenopausal osteoporotic women meeting FREEDOM eligibility criteria.
METHODS:
Data source: CPRD-GOLD and CPRD-AURUM, linked to HES-ONS
Source Population: postmenopausal women aged 60-90, who at during the identification period (01/01/2011-31/12/2018) had evidence of osteoporosis, defined as either a Âhistory of (non-traumatic) fracture or a Âdiagnosis of osteoporosis and were registered in CPRD for 1+ years in up-to-standard practices. Exclusion criteria will be applied to reflect FREEDOM eligibility criteria to the most possible extent.
Exposure: Denosumab 60mg for s.c. administration
Outcomes: Non-vertebral (incl. hip) fracture (primary outcome), overall fracture, clinical vertebral fracture and hip fracture (secondary outcomes).
ANALYSES:
This study will employ a cohort design. Risk for non-vertebral (incl. hip) fractures will be calculated via Cox-proportional hazard model over the course of a maximum of 36 months. The following methods to account for measures/unmeasured confounding will be applied:
1. Expert-based propensity score (PS)
o Matching
o Stratification
o Inverse probability weighting (IPW)
2. High-dimensional propensity score (HDPS)
o Matching
o Stratification
o Inverse probability weighting (IPW)
3. Disease risk score
4. Instrumental variablesFor each of the methods, we will report its outcome analysis finding and compare it with the FREEDOM trial findings individually. Results from the individual datasets will then be pooled in meta-analyses, and the pooled estimate compared with the FREEDOM RCT results using a set of pre-specified criteria for agreement.
Sensitivity analyses including negative control outcomes will be conducted.
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The risk of acute infection in patients with newly diagnosed depression: a cohort study — Susan Jick ...
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The risk of acute infection in patients with newly diagnosed depression: a cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-05
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Noah Aebi - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Julia Spoendlin - Collaborator - University of Basel
Undine Lang - Collaborator - University of BaselOutcomes:
The number of recorded diagnoses of either of the following acute infections (Read codes recorded on separate days, in Appendix):
- Respiratory infections
- Urogenital infections
- Gastrointestinal infections
- SepticemiaDescription: Technical Summary
Depression has been associated with an increased risk of infections. However, evidence for this potential association remains scarce, and two prior studies were subject to limitations in terms of methodology and generalizability.
We will conduct a retrospective cohort study using CPRD GOLD and HES-APC data to evaluate the incidence of acute infections (respiratory, urogenital, gastrointestinal, and septicemia) in patients with depression compared to patients who a) have no history of depression or b) have been newly diagnosed with epilepsy (active control to minimize surveillance bias) and have no history of depression.
We will calculate incidence rate ratios (IRRs) with 95% confidence intervals (CIs) to quantify the risk of acute infections associated with a depression diagnosis, compared to patients without depression and to patients with epilepsy. We will control for several baseline covariates by weighting analyses on fine strata of the propensity score.
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Association between haemoglobin levels and clinical outcomes and healthcare resource use in patients with sickle cell disease in England — Jay Were ...
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Association between haemoglobin levels and clinical outcomes and healthcare resource use in patients with sickle cell disease in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-10
Organisations:
Jay Were - Chief Investigator - Health iQ
Jay Were - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Boglarka Kovacs - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQ
Mico Hamlyn - Collaborator - Health iQ
Shea O'Connell - Collaborator - Health iQOutcomes:
Prevalence of SCD; haemoglobin levels; Demographics (Mean and median age on inclusion, age distribution by decade, sex distribution, deprivation, Charlson co-morbidity score distribution, mean and median follow-up, total and mean admitted time, smoking status, BMI, alcohol consumption), prevalence of VOCs, ACS, Hypertension, Asthma, Stroke, History of leg ulcer, Diabetes, Upper respiratory tract infections, Osteonecrosis, Transfusions in the year prior to index, Gallstones, Chronic pain, Neoplasms benign and malignant, CKD by stage, Sepsis); crude death rate in the cohort; Healthcare resource outcomes (prescriptions issued in primary care, GP appointments in primary care, number of inpatient admissions, inpatient length of stay, inpatient HRG tariffs, number of outpatient appointments, inpatient HRG tariffs, number of A&E attendance, A&E HRG tariffs ); Clinical outcomes (Stroke, PH, CKD, ESRD, Leg ulcer, Composite ACS/pneumonia, mortality)
Description: Technical Summary
With current advancements in drug research, there is hope that Sickle cell disease (SCD) can be managed by a once daily oral direct-acting haemoglobin modifier for chronic, prophylactic treatment of patients which would in turn reduce the morbidity, mortality and health care costs associated with them. However, there is limited understanding of the most at-risk patients which would affect the impact of targeted treatments if they are to be made available on the NHS. There is also a limited availability of knowledge on the risk of adverse clinical outcomes such as stroke in this group.
This study aims to ascertain the association between haemoglobin (Hb) levels and selected clinical outcomes and healthcare resource use in patients diagnosed with SCD. This will be done by creating a cohort of patients with SCD using an algorithm based on codes. Further sub cohorts will be created out of the main cohort based on Hb levels, genotype, age and medications prescribed.
We shall describe demographic characteristics, occurrence of clinical outcomes including stroke and mortality. Health care resource usage will also be calculated and reported for primary care, inpatient, outpatient and A&E activity including cost. Outcomes will be described as total, means, medians, percentage or rates as appropriate.
In the comparative analysis, we shall look to null hypothesise that there is no relationship between risk of adverse clinical outcomes and SCD. Among patients with and controls without SCD, unadjusted and adjusted odds, odds ratios and mean incidence along with 95% confidence intervals will be calculated for all selected clinical outcomes and death at 1-6 months, >6-12 months and >12 months on comparing each cohort to matched controls. We shall match on age and sex and adjust for any other risk factors that we may identify as having an effect on the dependent variables.
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Patient portal registration and healthcare utilisation outcomes of patients in the NHS General Practice. — Ceire Costelloe ...
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Patient portal registration and healthcare utilisation outcomes of patients in the NHS General Practice.
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-10
Organisations:
Ceire Costelloe - Chief Investigator - Imperial College London
Abrar Alturkistani - Corresponding Applicant - Imperial College London
Geva Greenfield - Collaborator - Imperial College London
Thomas Beaney - Collaborator - Imperial College LondonOutcomes:
Outcomes:
Study 1:
Primary outcomes:
Practice-level outcomes: Monthly patient portal registrations, Monthly all-cause General Practice appointment bookings; Monthly all-cause General Practice consultations attended stratified by type of consultation (face to face, telephone, e-consultation); Monthly all-cause General Practice repeat prescription requestsSecondary outcomes:
Patient-level outcomes:
Factors associated with patient portal registration at the time of registration (e.g. age, sex, ethnicity, deprivation, multimorbidity and primary healthcare utilisation patterns associated with patient portal registration);Practice-level outcomes:
Monthly General Practice appointment no-show; Monthly General Practice cancelled appointments.Study 2:
Primary outcomes:
Practice-level outcomes:
Monthly new patient portal registration rateSecondary outcomes:
Practice-level outcomes:
Monthly rate of all-cause General Practice appointment bookings; Monthly rate of all-cause General Practice consultations attended stratified by type of consultation (face to face, telephone, e-consultation); Monthly rate of all-cause General Practice repeat prescription request.Description: Technical Summary
Since 2015, the National Health Service (NHS) offered patient portals with functionalities to book appointments, request repeat prescriptions, and view GP record in all NHS England General Practices (GP). There are no current studies describing healthcare utilisation outcomes of patients registered to the portals in this context.
Research Questions: What are the monthly patient portal registration patterns during the study period?, What patient characteristics at index date (at patient portal registration) are associated with registration to a patient portal in NHS GPs?, Is there a difference in healthcare utilisation outcomes (appointment booking, consultations attended, repeat prescription requests) for patients before and after their registration to the online patient portal on a practice level?, What are the COVID-19 pandemic implications on patient portal registration on a practice level?, What are the COVID-19 pandemic implications on some healthcare utilisation measures (appointment booking, consultations attended, repeat prescription requests) for patients registered to the patient portal on a practice level?
Methods:
Our patient cohort will include all adult patients (â¥18 years) in CPRD who have registered to the patient portal anytime from 01/04/2014 (1 year prior to universal availability of patient portals in GPs) till the latest available data of 2021. Two retrospective cohort studies will be conducted:
Study 1: Will be a time-series analysis to track patient portal registration over time. Then we will perform an autoregressive integrated moving average (ARIMA) time-series analysis to estimate the healthcare utilisation patterns before and after portal registration.
Study 2: Will be an interrupted-time series (ITS) analysis focusing on the rate of new patient portal registrations during the COVID-19 pandemic from March 2019 until the latest data received for the study compared to the pre-pandemic period. We will use the same method (ITS) to examine the rate of primary care healthcare utilisation outcomes during the pandemic period.
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Prevalence, prediction, and health outcomes of cardioprotective medication reduction in the older UK population — James Sheppard ...
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Prevalence, prediction, and health outcomes of cardioprotective medication reduction in the older UK population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-27
Organisations:
James Sheppard - Chief Investigator - University of Oxford
Rik van der Veen - Corresponding Applicant - University of Oxford
Constantinos Koshiaris - Collaborator - University of Oxford
Kamal Mahtani - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Richard McManus - Collaborator - University of OxfordOutcomes:
Primary outcome
All-cause emergency hospitalisationSecondary outcome
All-cause mortality; Stroke; Myocardial infarction; Cognitive functioning; Acute kidney injury; Electrolyte abnormalities; Falls; Fractures; Hypotension; Syncope; Cardiovascular Mortality; Worsening Heart Failure; Haemorrhage; muscle disorders; liver dysfunction; gastrointestinal and intracerebral bleedingSpecific outcomes will be examined in relation to reduction of specific drug group; anticoagulants, antihypertensives, antihyperlipidemic, or antiplatelet
Description: Technical Summary
Background
Accumulation of multiple long-term prescription drugs has led to so called polypharmacy, which can be specified as appropriate polypharmacy and problematic polypharmacy. Problematic polypharmacy, when multiple medications prescribed inappropriately or where the intended benefit of therapy is not met, is a risk factor to develop therapeutic related harm. This is particularly important for older individuals prescribed medications for cardiovascular disease prevention, where physiological changes and frailty may make them more susceptible to adverse drug reactions. Current guidelines therefore advise using clinical judgement when prescribing in older patients, and in some circumstances, consider reducing (stopping) medications which may cause harm. However, evidence to support this is currently lacking.Aims
This study will examine the extent to which cardioprotective medication reduction (antiplatelets, anticoagulants, lipid-lowering, and antihypertensives) occurs in routine primary care practice. Furthermore, we aim to assess which patient characteristics predict medication reduction and examine the long-term safety and efficacy of cardioprotective medication reduction.Methods
Aim 1: Develop and validate algorithmic approach to determine first routine cardioprotective medication reductionAim 2: Derive predictors of cardioprotective medication reduction from population characteristics using a matched case-control design (outcome is first cardioprotective medication reduction) with conditional logistic regression. Predictors will include patient characteristics, disease and treatment status, and lab parameters.
Aim 3: Determine the long-term safety and efficacy of cardioprotective medication reduction in an UK primary care population. A matched cohort study will be used where patients will be matched based on GP practice level. The exposure is the first incidence of cardioprotective medication reduction. The primary outcome will be all-cause hospitalisation, secondary outcomes will include major adverse cardiovascular events and drug-specific adverse events. A cox proportional hazards model will be used in order to examine the relationship between medication reduction and outcomes.
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Time to insulin initiation among second-line antidiabetics in a cohort of patients with type 2 diabetes — Samy Suissa ...
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Time to insulin initiation among second-line antidiabetics in a cohort of patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-24
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Aurelie Pare - Collaborator - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Qi Zhang - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
YA-HUI YU - Collaborator - Georgia State UniversityOutcomes:
Our primary outcome of interest is the initiation of any type of insulin. The secondary outcome is time to treatment failure defined as the initiation of a new class of antidiabetic agents.
Description: Technical Summary
Type 2 diabetes is a common, chronic, metabolic disease that results from insulin resistance or insufficient insulin secretion. Maintaining adequate glycemia is essential for patients with type 2 diabetes to avoid the micro- and macrovascular complications of diabetes and to reduce mortality. Over the last two decades, several novel antidiabetic drug classes (e.g., DPP-4 inhibitors, GLP-1 receptor agonist, SGLT-2 inhibitors) have been introduced and are now recommended as second-line drugs for ttype 2 diabetes. Since each class of antidiabetic drugs presents unique benefits and side effects, the choice of second-line treatment should depend on patientsâ characteristics and risk profiles. However, real-world evidence is limited regarding the ability of second-line antidiabetic drugs to delay the initiation of insulin therapy. Only a few studies have examined this issue but were limited to within drug class comparisons, and several had important methodological limitations. Importantly, little is known about the impact of SGLT-2 inhibitors on time to insulin initiation since this class was introduced relatively recently.
Thus, we propose to compare the ability of second-line antidiabetic agents (insulin secretagogues, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors) to delay the time to insulin initiation in a contemporary cohort of patients with type 2 diabetes. Using CPRD Aurum, we will first establish a base cohort consisting of patients with type 2 diabetes initially treated with metformin monotherapy between 1998-2021. From this base cohort, we will select our final study cohort of patients initiating second-line treatment during 2013-2021. We will adopt an intention-to-treat approach and use inverse probability of treatment weighted Cox models to estimate the association of time to insulin initiation among these second-line antidiabetic agents. We will also compare the time to treatment failure, defined as the addition of or switching to another class of antidiabetic drugs.
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Morbidity, mortality, resource use, and financial cost of pruritus in chronic kidney disease patients in the UK general population: a retrospective matched cohort study — ...
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Morbidity, mortality, resource use, and financial cost of pruritus in chronic kidney disease patients in the UK general population: a retrospective matched cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-17
Organisations:
- Chief Investigator -
Melissa Perry - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Garth Baxter - Collaborator - Vifor Pharma
Jeevan Virdi - Collaborator - Vifor Pharma
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
All-cause mortality (primary);
incidence of skin infections (primary) ;
incidence of depression (primary);
incidence of sleep disorders (primary);
incidence of Major Adverse Cardiovascular Events (MACE) outcomes (primary);
rate of issuance of fit notes (secondary);
rate of HD sessions attended (secondary);
primary care resource use and costs (secondary);
secondary care resource use and costs (secondary);
cost of primary care prescriptions (secondary);
rate of prescriptions for phosphate binders (secondary).Description: Technical Summary
Chronic kidney disease associated pruritus (CKD-aP) is common, affecting an estimated 20% of patients with CKD, and 40% of patients with end stage renal disease. CKD-aP has been associated with increased mortality, reduced quality of life, sleep disturbances, mental health conditions, and skin infections as a result of persistent scratching. The treatments available at present for CKD-aP are often not sufficiently effective.
The primary purpose of this study is to characterise the risk of mortality, skin infection, depression, Major Adverse Cardiovascular Events and sleep disorders, in patients from the UK who are receiving HD and suffer from CKD-aP. In addition, this study will calculate the NHS resource use and costs of care associated with HD patients with CKD-aP, and compare the number of fit notes issued, phosphate binding medications prescribed, and number of dialysis sessions attended between the two cohorts.
To achieve this, data from the GOLD and aurum primary care datasets linked to that from HES admitted patient care, HES outpatient, and HES A&E to accurately determine exposures, outcomes, and co-variates. HD patients with CKD-aP will be matched by age (± 2 years), gender, Charlson Comorbidity Index (CCI), ethnicity, duration of HD (± 1 years), route of vascular access, and Index of multiple deprivation, to CKD patients receiving HD without a diagnosis of pruritus. Rates of progression to each primary outcome will be presented and compared using Kaplan Meier curves and Cox proportional hazard models. Generalized linear models will be constructed to compare resource use and costs (Poisson/binomial) and cost (Gamma) between treatments. All multivariable models will be adjusted for baseline characteristics.
This work will increase understanding of the mortality and morbidity risks, and healthcare resource use and costs, associated with development of pruritus in CKD patients on HD.
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Pharmacological treatments associated with increased or decreased risk of developing age-related macular degeneration: signal detection — Nicola Adderley ...
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Pharmacological treatments associated with increased or decreased risk of developing age-related macular degeneration: signal detection
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-23
Organisations:
Nicola Adderley - Chief Investigator - University of Birmingham
Nicola Adderley - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Ji Eun Diana Han - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Tom Taverner - Collaborator - University of BirminghamOutcomes:
Age-related macular degeneration
Description: Technical Summary
Aims: To explore whether there are medications in current use which are associated with an increased or decreased risk of subsequent development of age-related macular degeneration (AMD). This is intended as an exploratory pharmacovigilance study, to detect statistical signals for drug associations with AMD development, and highlight potential drug associations for further exploration. Following the analysis, after identifying drug classes with statistically significant and potentially clinically important associations with AMD, the findings will be discussed at a workshop with researchers and clinicians to identify clinically/biologically plausible associations warranting further investigation. We will also perform a similar exploratory analysis looking at comorbidities preceding a diagnosis of AMD.
Methods/design: We will perform case-control studies with a range of exposures to evaluate possible associations between various medications or morbidities and subsequent development of AMD. To limit false discovery rate, we will use the Benjamini-Hochberg p-value correction for false discovery rate due to multiple testing to select associations with corrected alpha < 0.05.
Outcome: AMD
Exposures: Drugs: All drugs available in the databaseâs product dictionary will be designated according to their ATC codes. Comorbidities: A list of 90 morbidities.
Participants: Adults aged 40 years and over and registered with the general practice for at least one year before the index date (start of follow-up) will be included. Cases will be patients with a primary care record of AMD identified by relevant Read codes. Each patient with AMD will be matched to control patients without AMD at the time of AMD diagnosis for age (± 1 year), sex, BMI (±2 kg/m2), smoking status, exposure window, and follow-up period (± 1 year).
Covariates: In addition to matching, we will adjust for age, sex, BMI, smoking status and comorbidity score to account for residual confounding.
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Health resource utilisation and cost burden of individuals with Amyotrophic Lateral Sclerosis (ALS) in England — Li Li ...
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Health resource utilisation and cost burden of individuals with Amyotrophic Lateral Sclerosis (ALS) in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-11
Organisations:
Li Li - Chief Investigator - Biogen
Katie Stenson - Corresponding Applicant - Biogen
Kim Heithoff - Collaborator - Biogen
Susan Eaton - Collaborator - Biogen
Varant Kupelian - Collaborator - Biogen Inc.Outcomes:
Mean and total annual resource utilisation, and associated costs for the following categories:
⢠Inpatient hospitalisations;
⢠Outpatient hospital visits;
⢠Primary care visits;
⢠Accident and emergency visits;
⢠Prescription medications;
⢠Medical procedures;
⢠Assistive medical devices (e.g., ventilators, wheelchairs)Description: Technical Summary
To describe and estimate the HCRU (frequency) and costs of outpatient visits, hospitalisations, medications, medical procedures, and assistive devices among adults newly diagnosed with ALS in England. The diseased group consists of those newly diagnosed with ALS based on Read/SNOMED codes and having no encounters with ALS diagnostic codes for 6 months prior to the index date. We will then match cases to controls without ALS diagnosis by age (at
randomly assigned index date), sex, and geographic region in a 1:5 ratio. We will use linked datasets to describe
and compare the annual mean HCRU of those with and without ALS in all categories.
Cumulative resource utilization from time of ALS diagnosis until occurrence of specific sentinel events (as
proxies for disease state/progression) such as use of parenteral nutrition (gastrostomy), ventilator, wheelchairs, will be
summarized through until death for the disease group. Descriptive analysis of proportions of patients who
have one or more sentinel events and time to occurrence of sentinel events from ALS diagnosis (index date)
will also be done using Kaplan Meier analysis. Mean HCRU in those diagnosed with ALS during the 6 months pre-diagnosis, month of diagnosis, and 6 months post-diagnosis, will be compared against controls. Descriptive statistics will be generated for all demographic and baseline variables (as available), including age, sex, marital status, and region. Continuous variables will be summarized by their means, standard deviations, median, interquartile range (25th, 75th percentiles), minima, and maxima. Categorical variables will be summarized with category-specific counts and percentages.The linked data sources planned for use in the descriptive analysis include:
⢠ONS Death Registration data.
⢠HES datafiles:
o HES Admitted Patient Care (APC) data,
o HES Outpatient (OP) data,
⢠Small area-level data - specifically the Index of Multiple Deprivation (IMD) linked to patient postcode.
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The effect of diabetes mellitus on perioperative outcomes following colorectal resectional surgery — David Humes ...
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The effect of diabetes mellitus on perioperative outcomes following colorectal resectional surgery
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-10
Organisations:
David Humes - Chief Investigator - University of Nottingham
Christopher Lewis-Lloyd - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Dileep Lobo - Collaborator - University of NottinghamOutcomes:
⢠90-day mortality
⢠Length of hospital stayDescription: Technical Summary
Background:
Diabetes mellitus (DM) is a common condition with a UK prevalence of 3.9 million (1 in 17) people diagnosed with the condition that is expected to increase significantly. The disease impacts the morbidity and mortality outcomes following surgery with specific national guidance detailing its peri-operative management. DM affects more than 10% of patients undergoing surgery with a peri-operative mortality as high as 50% greater than those without the condition.There have been several population-based cohort studies from Australia, the USA, the Netherlands and Denmark showing conflicting results regarding the post-operative outcomes of patient with DM following colorectal resection and specifically there is a lack of evidence from large primary and secondary care linked UK population data.
Objective:
To quantify the risk and therefore assess the impact DM confers following colorectal surgery compared to the general population and assess whether there are differences in outcomes between the types of DM including differences in treatment regimen. This will aid future guidance with respect to the peri-operative management of DM in the UK.Design:
The linked primary and secondary care databases (Clinical Practice Research Datalink, Hospital Episode Statistics) together with mortality data from the Office of National Statistics will be used to establish a cohort of patients undergoing colorectal resectional surgery. 90-day mortality will be compared between those with DM and those without undergoing colorectal resectional surgery. We will control for the confounders of age, gender, BMI, smoking, malignant and benign disease, along with emergency and elective admission and whether the procedure was performed in a minimally invasive way (robotic or laparoscopic).Outcomes:
We will provide stratified population-based estimates of the length of stay and mortality rates up to 1-year following colorectal surgery in diabetic patients.
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Investigating the effect of influenza vaccine on acute cardiovascular events by cardiovascular risk status — Charlotte Warren...
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Investigating the effect of influenza vaccine on acute cardiovascular events by cardiovascular risk status
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-25
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jennifer Davidson - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amitava Banerjee - Collaborator - University College London ( UCL )
Clémence Leyrat - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
We will use the same primary and secondary cardiovascular outcomes as detailed in our ISAC protocol no. 19_209, with the exception of cardiovascular death (note death excluded as an outcome due to SCCS design in which an event of interest must not censor the observation period, see "Data/statistical analysis" and "Limitations" sections for further details).
Primary outcome:
First major adverse cardiovascular events (MACE). This includes; acute coronary syndrome (ACS) which captures both myocardial infarction (MI) and unstable angina, stroke, transient ischaemic attack (TIA), left ventricular heart failure and acute limb ischaemia.Secondary outcomes:
Individual cause-specific acute cardiovascular events:
⢠acute coronary syndrome (subdivided into MI and unstable angina),
⢠stroke / TIA,
⢠left ventricular heart failure.Description: Technical Summary
Observational studies have identified that acute respiratory infections can trigger acute cardiovascular events, particularly myocardial infarction and stroke. In self-controlled case series (SCCS) studies, which implicitly control for the effect of fixed confounding factors using within-individual comparisons, myocardial infarction and stroke risk were elevated two- to six-fold in the days following clinically diagnosed respiratory infections and influenza-like illness, with this elevated risk remaining for up to one month. Consistent cardiovascular triggering effects have been found for laboratory-confirmed infections, including the influenza virus. Randomized controlled trials and observational studies have also demonstrated the cardiovascular benefit of the seasonal influenza vaccine. However, randomized controlled trial data is largely limited to individuals with established cardiovascular disease (CVD). While observational studies have considered the vaccine's benefit among those without a previous cardiovascular event, the benefit specifically in people with raised cardiovascular risk has not been considered. Quantifying any protective effects of influenza vaccine in people with raised cardiovascular risk, predictive of future CVD, will further understanding of the vaccineâs cardiovascular benefits and whether it is effective for primary prevention of CVD.
We aim to investigate the association between influenza vaccination and major adverse cardiovascular events in a SCCS study, focusing on the effect of raised cardiovascular risk level, defined by QRISK2 score â¥10% and diagnosed hypertension, on any association. We will use CPRD Aurum and HES admissions data from 2008-2019 and include all adults aged 40-84 years who had seasonal influenza vaccine and experienced their first major adverse cardiovascular event in the same year as vaccination was given. SCCS design removes between-person confounding, a major issue in vaccine effectiveness studies using observational data. In conditional Poisson regression models adjusted for season, we will calculate incidence ratios. We will also stratify by patient cardiovascular risk status.
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The impact of learning disabilities on control of type 2 diabetes risk factors and outcomes in UK primary care — Rohini Mathur ...
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The impact of learning disabilities on control of type 2 diabetes risk factors and outcomes in UK primary care
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-23
Organisations:
Rohini Mathur - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Archie Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Haemoglobin A1c (HbA1c)
Blood Pressure
Macrovascular and microvascular complications
Prescription of antidiabetic medication
All-cause and diabetes-related MortalityDescription: Technical Summary
People with learning disabilities (LDs) experience higher rates of mortality, chronic disease, and Type 2 Diabetes (T2DM). There is little evidence exploring the impacts of LDs on control of diabetes-related risk factors and outcomes such as cardiovascular and microvascular disease. It is hypothesised that later diagnosis and poor glycaemic control contribute to worse outcomes, but the extent of these contributions is unknown. The aim of this study is to assess the impact of LDs on the control of cardiometabolic risk factors and clinical outcomes amongst people with T2DM.
Linear and logistic regression will be used to assess differences in control of cardiometabolic risk factors. Cox proportional hazards regression will be used to examine differences in the risk of vascular complications, initiation of insulin and mortality between those with and without LDs. Sensitivity analyses will be conducted to explore outcomes by subtypes of LD. This can allow us to better understand differences in the progression of T2DM in those with and without LDs. This research will identify the need for updating T2DM care guidelines to meet the needs of those with LDs, a population that carries a proportionally larger burden of chronic diseases.
Index of multiple deprivation (IMD) is a key confounder in this study and must be controlled for in analyses. We will use patient level IMD where available and practice level IMD elsewhere to reduce missing data points. Premature mortality is an important outcome of type 2 diabetes- determining whether this differs between people with and without learning disabilities is important for understanding if inequalities exist and generating hypotheses for how these can be mitigated. Linked ONS data will be essential for identifying diabetes-related and all-cause mortality as it contains information on the underlying cause of death and accurate date of death not available in the primary care data.
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Use and effectiveness of non-pharmaceutical interventions for mild to moderate depression — Till Bärnighausen ...
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Use and effectiveness of non-pharmaceutical interventions for mild to moderate depression
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-06
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Justine Davies - Collaborator - University of Birmingham
Maximilian Schuessler - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
We will explore the effects on the following primary outcome:
- Persistence of non-severe depression (i.e., repeated depression diagnosis and/or uptake of medication, see section âExposures, outcomes and covariatesâ)We will also explore the following secondary outcomes
- Number of all-cause emergency hospitalizations
- Number of severe adverse health events (stroke, heart attack [myocardial infarction] â each event type evaluated separately)
- All-cause mortality
- Suicide
- Number of GP visits
- Number of medications
- BMI
- Blood pressure
- Smoking status
- Recorded hazardous alcohol consumptionTo address missingness of data, we will use multiple imputation for missingness in the covariates and pairwise deletion for the outcome variables (see relevant section below for more detail).
Description: Technical Summary
This study focuses on the patterns of use and real-life effectiveness of non-pharmaceutical interventions in UK primary care. Previous studies investigating the health effects of non-pharmaceutical interventions administered to people diagnosed with non-severe depression are largely limited to controlled clinical trials and small-scale observational studies. First, this study explores the use of non-pharmaceutical interventions in UK primary care in adherence to current guidelines for non-severe depression, for which they are recommended as a first line option, by studying the proportion of patients who received a non-pharmaceutical intervention upon being diagnosed with non-severe depression. Second, while previous studies have pointed towards the efficacy of non-pharmaceutical interventions in improving key outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the time horizon to study long-run benefits and risks. Thus, we aim to explore the use of non-pharmaceutical interventions on short-, mid-, and long-term physical and behavioural outcomes in a routine care set-up. For these analyses, we apply an advanced matching technique relying on machine learning - DAME (developed by the Duke Almost Matching Exactly Lab) - which is built to learn the proper metric to be used by weighting those covariates more which directly contribute towards the treatment effect more. Upon matching our treatment and control groups and to determine whether outcomes of patients differ between patients in each subgroup, we apply mean comparison tests. Finally, we test for heterogenous treatment effects by stratifying our sample by sex, age, socioeconomic status, ethnicity and comorbidities. Multiple testing is accounted for using the Benjamini-Hochberg method to take into consideration the number of subgroups and primary outcomes. The findings of this study are expected to provide novel insights into the use and effectiveness of non-pharmaceutical interventions in a real-life setting and can directly inform clinical practice.
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Use of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter-2 Inhibitors for the Prevention of Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes — Samy Suissa ...
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Use of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter-2 Inhibitors for the Prevention of Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Non-alcoholic fatty liver disease (Read codes and SNOMED-CT concept IDs outlined in Appendix 1).
Description: Technical Summary
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 (SGLT-2) inhibitors, by virtue of weight-reducing and anti-inflammatory effects, have been shown to reduce liver fat and resolve hepatic inflammation. However, whether these drugs reduce the risk of NAFLD in patients with type 2 diabetes in the real-world setting is unclear. Accordingly, in this population-based cohort study, we will compare the incidence of NAFLD among new users of GLP-1 RAs and SGLT-2 inhibitors, separately, with new users of dipeptidyl peptidase-4 (DPP-4) inhibitors among patients with type 2 diabetes. Thus, this study will use the Clinical Practice Research Datalink to assemble two new-user, active comparator cohorts of patients at least 40 years of age, one comprising of new users of GLP-1 RA and DPP-4 inhibitors between January 1, 2007 and April 30, 2020, and the other comprising of new users of SGLT-2 inhibitors and DPP-4 inhibitors between January 1, 2013 and April 30, 2020. Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of NAFLD associated with GLP-1 RAs and SGLT-2 inhibitors compared with DPP-4 inhibitors. Secondary analyses will assess whether there is a duration-response relation, and whether there is effect measure modification by age, sex, use of lipid lowering agents, and body mass index.
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Comparison of modelling methods for risk prediction of cardiovascular outcomes in patients with hypertension — Min...
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Comparison of modelling methods for risk prediction of cardiovascular outcomes in patients with hypertension
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-18
Organisations:
Min-Hua Jen - Chief Investigator - Eli Lilly & Co - UK
Min-Hua Jen - Corresponding Applicant - Eli Lilly & Co - UK
Alex Bottle - Collaborator - Imperial College London
Antje Hottgenroth - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Douglas Faries - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Ilya Lipkovich - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Luis Emilio Garcia Perez - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Xiaohong Li - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Outcomes: Incident cardiovascular disease (acute coronary syndromes, stroke, peripheral vascular disease) and (separately) incident heart failure
Description: Lay Summary
Medications proven to be effective in rigorous clinical trials are then used by GPs and other healthcare professionals in their daily practice. This daily practice is recorded in electronic patient records, which can be used by researchers with ethical approval. The Clinical Practice Research Datalink (CPRD) is one such âreal-worldâ research database, including patient records for around 10% of UK GP practices. Such databases differ from clinical trial databases in key ways such as having a broader range of patients but lower data quality. Researchers wishing to use CPRD need to understand problems such as missing data and the fact that when patients change GP practice to one not covered by CPRD, they âdisappearâ from CPRD. In this proposal, our team plans to undertake various statistical analyses to see what impact these data problems have on the results and what are the best ways to overcome them.
Technical Summary
To make the research concrete, we will analyse records for patients newly diagnosed with high blood pressure and build statistical models to predict which kinds of patients are at higher risk of cardiovascular disease after diagnosis. A particular modelling challenge is how to deal with the fact that blood pressure changes over time, which can be tackled in different ways, so far without agreement on the best way to do this. The project will benefit patients and their GPs, by providing better information regarding cardiovascular disease risk, and researchers, by providing a framework for their analysis with real-world data such as CPRD.Statistical models to estimate the risk of patient outcomes over time can either be generated from trial databases or real-world data. Methodological challenges such as loss to follow-up, time-varying covariates, measurement error, clustering and missing data can limit their validity, irrespective of data source, but the best approach to tackle these challenges is not known. Using hypertension and cardiovascular outcomes as our case study, simulation will assess the impact on predicted cardiovascular disease (CVD) risk for a range of scenarios regarding informative drop-out and missing values; this is because with simulation, the true relation between each risk factor and the outcome is known. We will compare a range of modelling approaches to handle predictors such as systolic blood pressure (BP) and BMI that change over time. The simplest approach will be Cox models using aggregated patient-level predictors (BP etc) and time-varying covariates. More advanced approaches to compare with it will include mixed effects Cox models, joint modelling, and trajectory classification: the last of these will be used to describe the different ways in which BP changes over time, with the trajectory used as a predictor in other models. To deal with the competing risk of non-CVD death, we will also apply subdistributional and cause-specific hazards and compare with Cox outputs. In all approaches, sensitivity analyses will assess the impact on risk estimates of measurement error in the outcome by using different definitions of the outcome, especially different ICD10 codes for CVD.
We aim to produce analytical guidelines for risk prediction models to advise on how to assess and handle these challenges.
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Natural history of coagulopathy and use of anti-thrombotic agents in COVID-19 patients: a cohort study —
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Natural history of coagulopathy and use of anti-thrombotic agents in COVID-19 patients: a cohort study
Datasets:GP data, HES APC, ONS, Patient IMD
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-07
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Edward Burn - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Nathan Jones - Collaborator - University of Oxford
Outcomes: The occurrence of venous thromboembolic and arterial thromboembolic events will be identified in the 30-, 60- and 90-days post-index date. COVID-19 worsening will be defined as increasing care intensity (e.g. from outpatient to inpatient, from inpatient to receiving intensive care services) and/or mortality.
Description: Lay Summary
People with coronavirus disease-2019 (COVID-19) may be at a high risk of thrombotic disease, where blood clots block veins or arteries. There is a need to better understand how common these thromboembolic events among patients with COVID-19 are, their implications for health outcomes, and whether individuals with a particularly high risk for them can be identified.
Technical Summary
We plan to perform such research using primary care data linked to hospital records from the UK. This will be part of a network study where the same analyses will be performed using similar data from other countries (facilitated by using a common data model, with no patient-level data needing to be shared between sites). First we will assess how common thromboembolic events are among patients with COVID-19, second we will consider the impact of these events on the likelihood of patients having worse outcomes, third we will describe the impact of patient characteristics on their risks of having a thromboembolic event, and fourth we will develop algorithms to identify those people most at risk of having one of these events.
The findings from our study will inform the management of COVID-19 patients.We will investigate the risks of thromboembolic and rare coagulopathy events among patients with COVID-19, the impact of thromboembolic events on prognosis in COVID-19, the association between various risk factors and rates of thromboembolic events, and to develop and externally validate prediction models for thromboembolic events for patients with COVID-19.
The study will be a distributed network study using datasets mapped to the Observational Medical Outcomes Partnership (OMOP) common data model. Primary care data, linked to hospital records, from the UK will be one of the contributing databases. Linked data will be used to maximize completeness for hospital study outcomes. By using a common data model, no data will need to be shared between sites.
Four study cohorts will be defined: 1) Persons tested positive for SARS-CoV-2,2) Persons tested positive for SARS-CoV-2 or with a clinical diagnosis of COVID-19, 3) Persons hospitalised with COVID-19, and 4) Persons requiring intensive services during a hospitalisation with COVID-19. The occurrence of venous thromboembolic and arterial thromboembolic events will be identified in the 30-, 60- and 90-days post-index date. COVID-19 worsening will be defined as increasing care intensity (e.g. from outpatient to inpatient, from inpatient to receiving intensive care services) and/or mortality.
We will summarise the incidence of venous and arterial thromboembolic and coagulopathy events at 30, 60, and 90 days following the relevant index date for study cohorts as a whole and for various strata of interest. We will use a multi-state model to summarise risks of worsening stratified by those with and without thromboembolic events of interest. The impact of risk factors on risks of venous and arterial thromboembolic events will be assessed using Cox models. Patient-level prediction models for thromboembolic events will be developed using a data-driven approach, with external validation performed across the network of contributing databases.
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Examining the change in risk of stroke and bleeding over time in patients with atrial fibrillation: A population-based cohort study using the Clinical Practice Research Datalink — Deirdre Lane ...
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Examining the change in risk of stroke and bleeding over time in patients with atrial fibrillation: A population-based cohort study using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-18
Organisations:
Deirdre Lane - Chief Investigator - University of Liverpool
David Stevens - Corresponding Applicant - University of Liverpool
Gregory Lip - Collaborator - University of Liverpool
Ruwanthi Kolamunnage-Dona - Collaborator - University of Liverpool
Stephanie Harrison - Collaborator - University of Liverpool
Outcomes: Mortality; Ischaemic stroke or systemic embolism; Heart failure - incident or prevalent; Major bleeding; Cardiovascular disease; Myocardial infarction; Dementia; Hospitalisation â all-cause or cardiovascular
Description: Lay Summary
Atrial fibrillation is a common irregular heart rhythm (arrhythmia) and increases a personâs risk of stroke five-fold. The Atrial Fibrillation Better Care (ABC) pathway has been developed to help make a clear plan of care for patients and clinicians. It follows three steps: A - Avoid strokes; B - Better symptom management; C - Cardiovascular risk management. The âAâ part of the pathway is anticoagulation medication, therefore, the risk of stroke must be balanced against the risk of bleeding, but a personâs risk can change over time.
Technical Summary
We will use a large anonymised database of patients in England which links electronic health records (e.g. GP visits, hospital visits) to answer the following five questions: (1) How does treatment adherent to the ABC pathway affect outcomes in atrial fibrillation patients? (2) How much does the risk of stroke and bleeding change over time in atrial fibrillation patients? (3) What is the best way to predict a personâs change in risk of stroke or bleeding? (4) How can the change in risk of stroke or bleeding over time best be used to help reduce someoneâs overall risk? and (5) How frequently does risk need to be reassessed?
Clinicians and patients require clear information to assess the risks and benefits of medications to reduce stroke risk. We hope that the results of this study will indicate how changing risk can be best incorporated into decisions about anticoagulation therapy. The results will help to improve future care and decision making for atrial fibrillation patientsAtrial fibrillation (AF) is the most common arrhythmia and increases a personâs risk of stroke five-fold. Oral anticoagulants (OACs) are recommended for the majority of individuals with AF to reduce their risk of stroke; however, anticoagulation also increases the risk of major bleeding. The CHA2DS2-VASc and HAS-BLED risk scores are advocated to assess risk for stroke and bleeding, respectively, in clinical practice. Both stroke and bleeding risk have the potential to change over time as patients age and develop new comorbidities. The change in CHA2DS2-VASc and HAS-BLED scores have been shown to perform better than baseline or follow-up scores in predicting stroke and major bleeding.
The Atrial Fibrillation Better Care (ABC) pathway is an integrated management pathway for patients with AF with three components: A - Avoid stroke with anticoagulation; B - Better symptom management and C - Cardiovascular risk management. Previous studies have shown that adherence to the ABC pathway at baseline is associated with lower risk of mortality, stroke, myocardial infarction, hospitalization and composite outcomes. We will treat adherence status as a time-dependent variable.
This project will use the Clinical Practice Research Datalink (CPRD), which is a representative sample of the primary care population in England. We will address the following four aims: 1. To compare the performance and flexibility of risk prediction models incorporating time-dependent risk factors. 2. To examine how changes in ABC pathway adherence over time impact the risk of adverse outcomes. 3. To model the trajectory of the CHA2DS2-VASc and HAS-BLED risk scores and other risk factors, and their associations with outcomes including incident stroke and major bleeding. 4. To evaluate the trajectory of the net clinical benefit of anticoagulation (the difference between the decrease in risk of a stroke on OAC and the increase in risk of a major bleed on OAC).
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Investigating the influence of ethnicity in Atrial Fibrillation, focusing on the epidemiology, risk factors and outcomes; a population based study. — G. Andre Ng ...
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Investigating the influence of ethnicity in Atrial Fibrillation, focusing on the epidemiology, risk factors and outcomes; a population based study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-11
Organisations:
G. Andre Ng - Chief Investigator - University of Leicester
Tom Norris - Corresponding Applicant - University of Leicester
Akash Mavilakandy - Collaborator - University of Leicester
Bharat Sidhu - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Nilesh Samani - Collaborator - University of Leicester
Zakariyya Vali - Collaborator - University of LeicesterOutcomes:
Atrial fibrillation, transient ischemic attack (TIA), myocardial infarction, ischemic stroke, heart failure, mortality, prescription (and pick-up) of oral anticoagulants (both warfarin and non-vitamin K OACs) and antiarrythmic drugs, referral rates for pacemakers and implantable cardioverter defibrillators, hospital admissions, diagnosis of COVID-19.
Description: Technical Summary
Atrial Fibrillation (AF) is the most common arrhythmia seen in clinical practice, affecting approximately 1.4 million people in the UK.[1] AF is a major causative factor for ischaemic stroke.[2] Identifying patients with AF is vital for the prevention of stroke and its consequences. The CHA2DS2-VASc score is used to determine AF and stroke risk based on several risk factors.[3] As part of the interaction between ethnicity, AF and stroke we need to investigate differences in risk factors, compliance of prescription and dosing.
Rates of AF are lower amongst South Asians,[6,7,8] despite having many of the established risk factors for AF. It has also been shown that there are fewer pacemakers and implantable cardioverter defibrillators being implanted in South Asians.[9,10] Suggestions as to why the prevalence of AF is lower than expected in South Asians include a lower attendance to medical services.[7,8,11] There may also be a genuine lower incidence of AF in South Asians despite a similar (or worse) risk factor profile compared to Caucasians. More importantly, stroke rate is high in South Asians. Therefore the mechanisms underlying the interactions between risk factors in the causation of stroke may be different in different ethnicities.
This will be an observational cohort study of individuals with and without a diagnosis of AF and of South Asian, African Caribbean and Caucasian ethnicity. Poisson regression will assess whether AF incidence and the co-morbidities associated with AF, differ between ethnicities. Survival models will investigate the association between AF and subsequent risk of heart failure, TIA, stroke or mortality. An interaction between AF and ethnicity will be included to explore whether risk of events and AF differs by ethnicity. To investigate disruptions to AF detection and management as a result of COVID-19 pandemic, we will employ an interrupted time series analysis framework, stratified by ethnic group.
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Evaluating ethnic differences in blood markers of cancer in primary care — Sarah Bailey ...
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Evaluating ethnic differences in blood markers of cancer in primary care
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; No additional NCRAS data required; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-04
Organisations:
Sarah Bailey - Chief Investigator - University of Exeter
Sarah Bailey - Corresponding Applicant - University of Exeter
Luke Mounce - Collaborator - University of Exeter
Melissa Barlow - Collaborator - University of Exeter
Sam Merriel - Collaborator - University of Exeter
Tanimola Martins - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
Incident cancer in the year following index date for each test, as determined by recorded ICD10 codes (C00-C97). Incident cancer will be the patient's first record of this cancer in their history.
Description: Technical Summary
Background
Ethnic minority groups in the UK have poorer cancer outcomes than British White groups. Improving cancer detection strategies for this population may improve outcomes and reduce health inequality. Most cancers are diagnosed following primary care consultation; general practitioners have access to blood tests used in the selection of patients for investigation for possible cancer. Despite evidence of differences in blood test reference ranges in different ethnic groups, research and guidance on these tests do not account for ethnicity.Research question
Do blood test results used to identify possible cancer in primary care vary between people of different ethnic groups, in terms of their usefulness to predict cancer?Methods
Cohort study with linked NCRAS&HES data to determine the incidence of cancer in people of Black, White, Asian, Mixed, or Other ethnicities following one of the following abnormal blood test results in primary care: platelet count, haemoglobin/mean cell volume, cancer antigen 125 (Ca125), creatine reactive protein (CRP), prostate specific antigen (PSA), and serum calcium. Sub-cohorts will be derived for each test. The outcome measure will be cancer in the year following that test. Multi-level logistic regression models will be constructed for each sub-cohort, including an interaction term for ethnic group, which will indicate if the effect of the test result differs by ethnicity. We will estimate the positive predictive values for cancer for each ethnic group.How the results of this research will be used
These results will enable more precise estimates of cancer risk in patients with abnormal blood test results, which will contribute to better diagnosed work-up in primary care and better selection of patients for further investigation for suspected cancer. These results will be used to inform primary care cancer detection practice and policy, such that clinical recommendations will take ethnic differences in cancer risk into account.
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Effectiveness of triple therapy versus dual therapy in patients with chronic obstructive pulmonary disease who have had one severe or two or more moderate exacerbations within one year — Jennifer Quint ...
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Effectiveness of triple therapy versus dual therapy in patients with chronic obstructive pulmonary disease who have had one severe or two or more moderate exacerbations within one year
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-12
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Alexander Adamson - Corresponding Applicant - Imperial College London
Cosetta Minelli - Collaborator - Imperial College LondonOutcomes:
In order to holistically assess the impact of triple therapy vs dual therapy, we will look at a number of outcomes:
Mortality rate (all cause, COPD related, and cardiovascular disease (CVD) related); severe AECOPD rate (= number of hospitalisations for AECOPD); moderate and severe AECOPD rate; rate of pneumonia diagnosis ; change in lung function (FEV1); change in breathlessness (mMRC) (if allowed by the data); number of A&E visits for AECOPD; Prescription of additional chronic therapy (theophylline or other methylxanthines); maintenance OCS; macrolides (e.g. azithromycin, erythromycin); carbocysteine
Description: Technical Summary
The NICE guidelines state that triple therapy should be considered in patients on dual long-acting beta-agonist (LABA) + long-acting muscarinic antagonist (LAMA) therapy who experience 1 severe exacerbation or 2 or more moderate to severe exacerbations per year. This is based on randomised controlled trial (RCT) evidence that found reductions in severe AECOPD, however these studies also found increases in pneumonia and no affect on mortality. We will therefore assess this recommendation in a population using routinely collected data comparing those eligible for triple therapy who remain on dual therapy to those who step up to triple therapy. We will use a retrospective cohort study design to assess the effect of triple therapy on the primary outcomes of severe AECOPD rate, moderate-severe AECOPD rate, and mortality, and the secondary outcomes of pneumonia rate, A&E attendances, Forced Expiratory Volume in 1 second (FEV1), breathlessness measured using the modified medical research council (mMRC) dyspnoea scale, and drug prescription, using Cox regression, multi-level linear regression and Poisson regression. Demographic variables, comorbidities, COPD baseline variables, and healthcare usage at baseline will be included as covariates in the model to reduce confounding. The study will incorporate trial evidence on the effectiveness on triple therapy using a Bayesian framework to help mitigate the impact of âconfounding by indicationâ.
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Retrospective study estimating the incidence of alcoholic hepatitis in the United Kingdom — Sigrid Behr ...
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Retrospective study estimating the incidence of alcoholic hepatitis in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-26
Organisations:
Sigrid Behr - Chief Investigator - Novartis Pharma AG
Olorunfemi Oshagbemi - Corresponding Applicant - NOVARTIS
Olessia Zorina - Collaborator - NOVARTISOutcomes:
Primary outcome:
The primary outcome of the study will be AH using read code: J611, J617, J617000, or ICD-10 code: K70.1 from the clinical and referral files.Secondary outcome:
The secondary outcomes will included narrow definition for AAH defined as patients with alcoholic hepatitis (Read code: J611, J617 or ICD-10 code: K70.1) and at least one of the codes for the following diagnosis present: ascites, gastrointestinal haemorrhage, hepatic encephalopathy, cirrhosis, alcoholic hepatic failure, malnutrition. hepatorenal syndrome /renal failure, pancreatitis, alcohol abuse, alcohol dependence or alcohol withdrawal (see table appendix) from the referral and clinical filesFurthermore, we will aim to assess the incidence rate of AH using read code: J611, J617, J617000 or ICD-10 code: K70.1 or patients with hepatitis unspecified, without codes for Hepatitis C Virus (HBC)/Hepatitis B Virus (HBV)/Autoimmune hepatitis (AIH)/Primary biliary cholangitis(PBC)/Primary sclerosing cholangitis(PSC)/Hemochromatosis) and a code related to excessive alcohol consumption, alcohol abuse or alcoholism treatment referral and clinical files.
Description: Technical Summary
Alcoholic hepatitis is an acute manifestation of alcoholic liver disease with mortality as high as 40â50 % in severe cases. This disease results mostly from prolonged alcohol abuse with or without a known history of liver disease. Although there is significant variability in severity at presentation, patients with severe alcoholic hepatitis typically, present with anorexia, fatigue, fever, jaundice, and ascites.
In recent times only a few studies have tried to evaluate the trends of AH in Europe, with no recent study aimed at evaluating this question in the UK. Understanding trends of AH can help redirect healthcare policies and interventions to subgroups most affected by the disease, allow comparison between countries to aid healthcare planning, predict future healthcare challenges, and provide a basis for improving management in the future.
Thus the aim of this study will be to evaluate the annual incidence rates of AH by age and gender in the UK from 2016 to 2019. The rates for AH in each calendar year will be calculated as the sum of AH in that year divided by the total duration of follow-up, in the given calendar year. This will be expressed as the number of patients with AH per 1000 person-years. We will break down these rates by gender, age categories (<18y., 18-65y., >65y.) . All analyses will be carried out using SAS 9.4 (SAS Institute, Cary, NC).
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Developing a methodological framework for the clinical prediction of multimorbidity — Glen Martin ...
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Developing a methodological framework for the clinical prediction of multimorbidity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-17
Organisations:
Glen Martin - Chief Investigator - University of Manchester
Alexander Pate - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Gregory Lip - Collaborator - University of Liverpool
Iain Buchan - Collaborator - University of Liverpool
Jamie Sergeant - Collaborator - University of Manchester
Katherine McAllister - Collaborator - National Institute for Health and Clinical Excellence - NICE
Laura Bonnett - Collaborator - University of Liverpool
Mamas Mamas - Collaborator - Keele University
Martin O'Flaherty - Collaborator - University of Liverpool
Matthew Sperrin - Collaborator - University of Manchester
Michelle McDowell - Collaborator - Harding Center for Risk Literacy
Niels Peek - Collaborator - University of Manchester
Richard Riley - Collaborator - Keele University
Thomas Lawrence - Collaborator - National Institute for Health and Clinical Excellence - NICE
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
The primary outcome of interest in this study is multimorbidity, with a focus on developing a methodological framework to support the prediction of multimorbidity. In our case studies, we will consider multimorbidity to be the co-occurrence of two or more of:
Coronary Heart Disease (CHD)
Atrial Fibrillation (AF)
Stroke (including transient ischaemic attack)
Chronic Kidney Disease (CKD)
Type 2 Diabetes (T2D)
Cancer (colon, breast and lung)
DementiaDescription: Technical Summary
The overarching aim of this study is to develop statistical methodology to enable the clinical prediction of multimorbidity. This will include evaluating currently available methodology, and developing new methodology where appropriate. This will be undertaken in two work packages (WP). WP1 will provide motivation for and highlight the importance of this project. We will show that the univariate Cox models which are currently used in clinical practice to predict the development of chronic conditions, are unable to predict the risk of more than one disease co-occurring. This motivates the need for multivariate techniques (shared frailty, copula models, marginal approach) and multistate models for the prediction of multimorbidity. WP2 will look at how to best predict multimorbidity using existing multivariate and multistate models, and seek to understand why such methods are not commonly implemented in practice. The work will be largely simulation based, with the CPRD data used in case studies to elicit the differences between the methods of interest. HES and ONS will be used to determine outcome events that do not appear in the primary care records, as would be done in univariate models that are currently used in practice.
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Comparative effects of different antidiabetic treatments on COVID-19 mortality and vascular outcomes — Anna Schultze ...
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Comparative effects of different antidiabetic treatments on COVID-19 mortality and vascular outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-25
Organisations:
Anna Schultze - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Anna Schultze - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Christopher Sainsbury - Collaborator - University of Birmingham
Owen Taylor - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Selina Kim - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
This is a comparative study of two antidiabetic treatments, looking at a range of outcomes: both traditional microvascular and macrovascular outcomes, as well as outcomes specific to COVID-19. The latter has increased in clinical importance during the past year despite not being outcomes typically included in studies of anti-diabetic treatment outcomes. The specific drugs of interest in this study - gliptins and SGLT2i - have both been hypothesised to potentially impact COVID-19 outcomes (Sainsbury et al., 2021), therefore providing a specific rationale for this being included in the current project. We believe it is suitable to include this range of outcomes in a single project, as the population and exposure definitions will be identical despite different outcomes being studies. In response to reviewer comments raised during the ISAC review, the study team notes that this could be submitted as two different ISACs, if required.
The outcomes of interest are:
Microvascular disease (retinopathy, kidney disease, neuropathy), defined using Read codes
Macrovascular disease (coronary heart disease, stroke, myocardial infarction and heart failure), defined using Read codes and ICD-10 codes (in the hospital and ONS data).
COVID-19 (diagnoses, hospital admissions and mortality, defined using primary care codes, ICD-10 codes, and ONS death records)
All-cause mortality, defined using date of death as given in the ONS.Codelists available as supplementary materials (appendix I). It should be noted that microvascular and macrovascular disease will be defined as the first occurrence of either event listed. Although individual events may be described in sensitivity analyses, the primary outcome definitions will use combined end-points to ensure sufficient power.
Description: Technical Summary
Type 2 Diabetes Mellitus (T2DM) affects approximately ~5% of individuals in the UK, and can cause both microvascular complications, such as retinopathy, kidney disease and neuropathy, as well as macrovascular complications, such as coronary heart disease, stroke, myocardial infarction and heart failure. More recently, individuals with T2DM have also been found to be at increased risk of COVID-19 mortality, a risk which is particularly marked for those with poorly controlled diabetes (HbA1c levels > 58 mmol/mol).
The management of T2DM is complex, but drug treatment is commonly offered together with advice on lifestyle modification. Metformin, an oral antidiabetic agent, is the first-line drug treatment of T2DM in the UK, unless contraindicated or not tolerated. However, if glucose control remains poor or worsens despite initiation of metformin and lifestyle interventions, treatment is intensified by adding another oral antidiabetic agent: including pioglitazone, sulphonylurea, or one of the newer diabetic drugs DPP-4 inhibitors (DPP4-i, gliptins) or Sodium/glucose cotransporter-2 inhibitors (SGLT2i).
The efficacy and safety of oral antidiabetic agents have been determined in randomised controlled trials. However, there is limited data available on long-term microvascular and macrovascular outcomes following the first treatment intensification. Existing data indicate that SGLT2-i may provide greater reductions in HbA1c compared to gliptins over the medium term; although whether this will translate into a long-term benefit when considering clinical endpoints is not yet known. There have also been few studies looking at the impact of diabetic treatment choice and COVID-19 risk.
This study will use data from CPRD to describe and compare microvascular, macrovascular and COVID-19 outcomes among patients with T2DM receiving either a gliptin or SGLT2i in the UK. Multivariable regression modelling will be used to account for potentially confounding factors, and effect modification by ethnicity and social deprivation will be investigated.
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Effectiveness of vaccination policies and current treatment stratification approaches for pneumonia: A regression discontinuity analysis — Till Bärnighausen ...
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Effectiveness of vaccination policies and current treatment stratification approaches for pneumonia: A regression discontinuity analysis
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-31
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Bhautesh Jani - Collaborator - University of Glasgow
Justine Davies - Collaborator - University of Birmingham
Maike Hohberg - Collaborator - University Hospital Heidelberg
Manuel Hoffmann - Collaborator - University of Heidelberg
Maximilian Schuessler - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
1. Pneumococcal vaccination
Primary outcomes:
- number of all-cause hospitalisations
- number of hospitalisations plausibly related to respiratory diseases
- number of emergency hospitalisation
- admission to ICU
- all-cause mortalitySecondary outcomes:
- pneumonia-related complications (bacteraemia, ventilation, pleural effusion, pleura, lung abscess)
- serious adverse health events (such as meningitis, sepsis, or organ failure)
- pneumonia-related mortality2. Influenza vaccination
Primary outcomes:
- number of all-cause hospitalisations
- number of hospitalisations plausibly related to respiratory diseases
- number of emergency hospitalisation
- all-cause mortality
- admission to ICUSecondary outcomes:
- pneumonia-related complications (bacteraemia, ventilation, pleural effusion, pleura, lung abscess)
- serious adverse health events (such as meningitis, sepsis, or organ failure)
- pneumonia-related mortality3. Treatment based on CRB65 score
Primary outcomes:
- number of all-cause hospitalisations
- number of hospitalisations plausibly related to respiratory diseases
- number of emergency hospitalisation
- all-cause mortality
- admission to ICUSecondary outcomes:
- pneumonia-related complications (bacteraemia, ventilation, pleural effusion, pleura, lung abscess)
- serious adverse health events (such as meningitis, sepsis, or organ failure)
- pneumonia-related mortalityDescription: Technical Summary
This study uses a regression discontinuity (RD) approach to determine the effectiveness of current vaccine and treatment stratification approaches for people at risk for pneumonia. Current clinical guidelines recommend (i) both influenza and pneumococcal vaccination for patients above a certain age threshold and (ii) treatment options for patients with pneumonia above certain threshold values in the CRB65 score (calculated based on the following criteria: patients' level of confusion, blood urea nitrogen, respiratory rate, blood pressure, and age). The RD design takes advantage of this decision threshold to estimate the causal effects of (i) providing vaccination vs. not and of (ii) intensifying treatment for pneumonia vs not. Specifically, we aim to determine whether or not the primary and secondary outcomes differ among patients ages just below and just above 65 (the latter should be prioritized for influenza and pneumococcal vaccines) and among patients with pneumonia whose CRB65 scores are just below or above an arbitrary threshold (the latter should be hospitalized and should receive a more escalated antibiotic treatment regimen). Primary outcomes include hospitalizations, ICU admission, and all-cause mortality. Secondary outcomes comprise of pneumonia-related complications, serious adverse events (including, but not limited to, meningitis, sepsis, or organ failure), and pneumonia-related mortality. We will estimate âfuzzyâ RD models using a local linear regression and triangular weights to avoid overfitting the data and to give more influence to observations close to the threshold. In addition, we will use a mean squared error optimal bandwidth that is empirically derived. We assess the sensitivity of the results using alternative bandwidths (e.g. bandwidths that are 50%, 75%, 125%, and 150% of the empirically derived bandwidth). The findings of this study are expected to provide novel insights into the long-term health effects and appropriateness of using age- and score-based thresholds in pneumonia prevention and treatment.
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Identifying trends and causes of hospitalisations in people with and without the top 5 chronic conditions: a population-based study — Salwa Zghebi ...
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Identifying trends and causes of hospitalisations in people with and without the top 5 chronic conditions: a population-based study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-25
Organisations:
Salwa Zghebi - Chief Investigator - University of Manchester
Salwa Zghebi - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Dimitri Varsamis - Collaborator - NHS England
Evangelos Kontopantelis - Collaborator - University of Manchester
Mamas Mamas - Collaborator - Keele University
Martin Rutter - Collaborator - University of ManchesterOutcomes:
⢠Annual trends of i) hospital admissions by count, causes of admission, and type (elective vs. non-elective), by the conditions reportedly accounting for three-quarters of Ambulatory care sensitive conditions (ACSCs) spells (as appropriate per each of the five conditions), and ii) A&E attendances and outpatient visits (in years where HES A&E and HES OP data are available), categorised by patient characteristics of the matched cohorts.
⢠Risk for first and recurrent (readmissions within 30 days of hospital discharge) all-cause, condition-specific, and COVID-19-related hospital admissions, A&E attendances and outpatient visits.
⢠Risk for all-cause and condition-specific mortality (including COVID-19-related deaths).
Description: Technical Summary
Background/Aims
Hospitalisations have increased by up to 79% from the last decade in England and are a considerable NHS strain, placing unprecedented pressures on healthcare resources. Nearly 40% of admissions are unplanned. The top five chronic conditions responsible for premature mortality in England (>115,000 deaths/year) are cancer, heart disease, stroke, lung, and liver diseases. However, studies examining the hospitalisation trends of people with these conditions are lacking. We aim to identify the socio-demographic and clinical characteristics of patients with and without these conditions, identify the trends and predictors of first and recurrent hospitalisations and mortality.Methods
Using cohorts of people with each of these top five conditions between 2006-2020, matched to up to five comparators without any of these conditions on age, gender, and general practice. Descriptive analyses will be used to identify the socio-demographic (including ethnicity, social-deprivation) and clinical characteristics of the matched cohorts and the longitudinal trends, primary cause of admission, and type (planned or unplanned) of hospitalisations. These trends will be categorised by patient age; gender, history of past admissions, deprivation, geographic location, comorbidities, and ambulatory care sensitive conditions. Competing risk analysis will assess the time to first all-cause and condition-related hospital admission, A&E events and OP visits. Cox proportional hazards regressions will estimate the risk for recurrent hospitalisations and the association between hospitalisation (by type, cause, length of stay) and the risk of all-cause and condition-specific (including COVID-19) mortality.Expected impact
The findings can be a proxy for primary care quality to inform a more targeted and effective pre-hospitalisation care delivery (at primary care level) to the high-risk patient groups with potential benefits towards providing focus on what actions are needed to reduce premature mortality and admissions in people with these five conditions to assist better use of limited NHS resources.
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An assessment of clinical staff workload and predictors of clinical staff workload, in UK primary care settings — Tom Marshall ...
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An assessment of clinical staff workload and predictors of clinical staff workload, in UK primary care settings
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-05-06
Organisations:
Tom Marshall - Chief Investigator - University of Birmingham
Lyvia Guerrier de Dumast - Corresponding Applicant - University of Birmingham
Patrick Moore - Collaborator - University of BirminghamOutcomes:
The primary outcome of interest is clinical staff workload (frequency and duration of consultations) which is categorised according to the type of clinical staff (e.g., doctor, nurse, allied health professional).
Description: Technical Summary
This study proposes to conduct an assessment of current clinical staff workload, as well as its predictors.
Currently, NHS England predicts primary care clinical workload using patientsâ age and sex group, number of new registrations and deprivation banding (Gardiner and Everard, 2016). However, the workload generated by a patient in primary care is also determined by patientsâ clinical characteristics which may not be captured by age, sex and deprivation. By not making use of patient health-related data to predict staff workload, NHS workforce planners may overlook the importance of multimorbidity as a predictor of health service utilisation.
Including a patientsâ clinical characteristics in a workload prediction model may be relevant to the understanding of variation in primary care workload (GP and other clinical staff) and future trends in workload. This can help with workforce planning.
Data analysis will be carried out in two stages. Firstly, we will examine the characteristics of a sample of patients who are responsible for a high level of clinical workload, in particular the most common chronic diseases affecting these patients. A subsequent analysis will use stepwise linear regression analysis to determine the predictors of primary care workload. A measure of deprivation will be included in the analysis in order to take health inequalities and need for healthcare into account in the workload formula. NHS England currently uses the Index of Multiple Deprivation (IMD) as a proxy for need in more deprived areas in its workload model. Similarly, IMD will be used in this study as the deprivation variable.
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ID-130: Mental Health in Children and Young People — Imperial College Health Partners...
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ID-130: Mental Health in Children and Young People
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Mental health. Commercial
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ID-131: Extension Request: Hounslow Integrated Care Partnership — Hounslow and Richmond Community Healthcare NHS Trust...
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ID-131: Extension Request: Hounslow Integrated Care Partnership
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-21
Opt Outs: no information provided./p>
Organisations: Hounslow and Richmond Community Healthcare NHS Trust
Description: Hounslow.
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ID-133: Extension Request: Heart Failure Algorithm Validation and Calibration — Midlands and Lancashire CSU (MLCSU)...
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ID-133: Extension Request: Heart Failure Algorithm Validation and Calibration
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-21
Opt Outs: no information provided./p>
Organisations: Midlands and Lancashire CSU (MLCSU)
Description: Heart Failure. Commercial
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ID-132: Pilot intervention for young self-harm patients in NWL — Imperial College London...
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ID-132: Pilot intervention for young self-harm patients in NWL
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Self-harm.
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ID 126. Suicide Prevention Strategy Hammersmith & Fulham — London Borough of Hammersmith & Fulham...
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ID 126. Suicide Prevention Strategy Hammersmith & Fulham
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-21
Opt Outs: no information provided./p>
Organisations: London Borough of Hammersmith & Fulham
Description: Suicide in Hammersmith & Fulham.
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ID 129. Extension request – Evaluation of the impact of the Ôtotal triageÕ model using online consultations in general practice — Imperial Clinical Analytics Research & Evaluation (ICHNT) & NIHR Imperial Patient Safety Translational Research Centre...
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ID 129. Extension request – Evaluation of the impact of the Ôtotal triageÕ model using online consultations in general practice
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-21
Opt Outs: no information provided./p>
Organisations: Imperial Clinical Analytics Research & Evaluation (ICHNT) & NIHR Imperial Patient Safety Translational Research Centre
Description: Online consultations.
Source
2021 - 04
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Vaccination events data (Identifiable) (Direct Care) — Clinical professionals with access to the Summary Care Record application...
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To assist in theâ¯management of patients following COVID-19 vaccination. — IG-01971
Recipient Data Controller Organisation(s) : Clinical professionals with access to the Summary Care Record application
Approval Date: 02/04/2021
Purpose for which the data is being used: To assist in theâ¯management of patients following COVID-19 vaccination.
Dataset: Vaccination events data
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice Implied Consent (direct care)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: Will vary in each instance: Legal Obligation (General COPI Notice) Implied Consent (direct care) Express Consent (direct care) Other Statutory Authority
GDPR and Data Protection Act 2018: GDPR Article 6(1)(a) â Consent GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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PDS data (address details only)
SCR data from Spine, NHS number, First Name, Surname, Address, Reason for exemption request, clinician that has recommended patient not to be vaccinated or tested (Identifiable) (Secondary uses) — Department of Health and Social Care...
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The dissemination will enable the medical exemption certificate to be generated and sent to individuals requesting an exemption via the 119 service. This will allow medically exempt individuals to obtain a Covid Pass — IG-04405
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 10/04/2021
Purpose for which the data is being used: The dissemination will enable the medical exemption certificate to be generated and sent to individuals requesting an exemption via the 119 service. This will allow medically exempt individuals to obtain a Covid Pass
Dataset: PDS data (address details only) SCR data from Spine, NHS number, First Name, Surname, Address, Reason for exemption request, clinician that has recommended patient not to be vaccinated or tested
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary uses
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) - substantial public interest plus DPA 2018 Part 2 Schedule 1 para 6 - Statutory and governmental purpose
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - Legal Obligation GDPR Article 9(2)(g) - substantial public interest plus DPA 2018 Part 2 Schedule 1 para 6 - Statutory and governmental purpose
National Data Opt-out Applied: Not Applied - Legal Obligation overrides
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A comparison of clinical outcomes, health care resource utilisation and costs for patients with chronic lower limb ulcers including diabetic and venous ulcers when prescribed Prontosan (including solution and gel) and saline solution in England — Jay Were ...
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A comparison of clinical outcomes, health care resource utilisation and costs for patients with chronic lower limb ulcers including diabetic and venous ulcers when prescribed Prontosan (including solution and gel) and saline solution in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-22
Organisations:
Jay Were - Chief Investigator - Health iQ
Jay Were - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQ
Mico Hamlyn - Collaborator - Health iQ
Shea O'Connell - Collaborator - Health iQOutcomes:
Prevalence of chronic lower limb ulcers (CLLU); Prevalence of CLLU by wound healing agent; Demographics (Mean and median age on inclusion, gender, total, mean and median follow-up and socioeconomic status); Clinical characteristics (Time to diagnosis, Charlson co-mobidity score, lung function, smoking status, comorbidities, type of ulcers, mobility restriction, previous ulcers, Ankle Brachial Pressure); treatment pathway(prescriptions issued in primary care, time from diagnosis to treatment); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality, referrals, wound healing, wound related infections, prescriptions in primary care (bandages, analgesics, antibiotics, dressings), amputations, tissue viability)
Description: Technical Summary
Chronic lower limb ulcers/wounds (CLLU) including diabetic and venous foot ulcers account for a substantial health burden nationally, with an estimated cost representing a total of 2% expenditure of the NHS. This cost burden includes primary care, secondary care stays, surgeries and prescriptions. Traditionally, saline or tap water has been used to clean ulcers prior to applying dressings. Alternatives to saline or tap water include propylbetaine-polihexanide solution (Prontosanâ¢) a wound cleansing agent used to prevent and remove biofilms.
We are interested in conducting a comparative study of the Healthcare Resource Utilisation (HRU) of patients with CLLU prescribed Prontosan and saline solution demonstrating that the use of Prontosan leads to better HRU, costs and improved clinical outcomes including faster healing and reduced occurrence of infection. This study will provide evidence to whether the use of Prontosan leads to lower costs in real-world practice.
This shall be a retrospective cohort study on a clinical healthcare dataset linked to an administrative healthcare dataset. This study shall determine patients that have been diagnosed with CLLU and
describe their demographic and clinical characteristics as well as treatment received and healthcare burden and cost.The study will also involve a comparative element with the aim of comparing outcomes between patients prescribed Prontosan (including solution and gel) compared to those prescribed saline solution with a null hypothesis that a difference exists within the two cohorts. This will be modelled using a multivariate Cox proportional hazards regression. Kaplan-Meier analysis will be performed to compare time-event-for wound healing between Prontosan vs. saline prescribed patients.
The study design has been chosen as it is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for procedures, demographics, costs, complications, readmissions and resource use.
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Long COVID in non-hospitalised individuals: symptoms, risk factors and syndromes — Shamil Haroon ...
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Long COVID in non-hospitalised individuals: symptoms, risk factors and syndromes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-26
Organisations:
Shamil Haroon - Chief Investigator - University of Birmingham
Shamil Haroon - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Georgios Gkoutos - Collaborator - University of Birmingham
Grace Turner - Collaborator - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Melanie Calvert - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of Birmingham
Nikita Simms-Williams - Collaborator - University of Birmingham
Olalekan Lee Aiyegbusi - Collaborator - University of Birmingham
Puja Myles - Collaborator - CPRD
Tim Williams - Collaborator - CPRD
Tom Taverner - Collaborator - University of BirminghamOutcomes:
(1) Symptoms in patients with COVID-19 (coded in health records)
(2) Long COVID symptom clusters
(3) A&E attendances
(4) Hospital admissions
(5) ICU admissions
(6) All-cause and cause-specific mortalityDescription: Technical Summary
We will undertake a retrospective cohort study of individuals with COVID-19 who have had a positive reverse transcriptase-polymerase chain reaction (RT-PCR) test result for SARS-CoV-2, without a record of hospitalisation in the 28-day period following COVID-19 diagnosis, from 30th January 2020 to the most recent available date.
We will describe the demographic and clinical characteristics of the cohort. We will estimate the prevalence of symptoms during periods of âacute COVID-19â (within four weeks of diagnosis), âongoing symptomatic COVID-19â (four to twelve weeks from diagnosis), and âpost-COVID-19 syndromeâ or âLong COVIDâ (after twelve weeks of diagnosis) and compare the symptom prevalence to propensity score-matched patients without a diagnosis of COVID-19 within similar time intervals.
A list of >60 symptoms has been developed through a rapid review of 24 primary research studies. These relate to multiple organ systems including cardiopulmonary, naso-oropharyngeal, gastroenterological, musculoskeletal and neuro-psychological. Those presenting with at least one symptom at 12 weeks or longer after COVID-19 diagnosis will be classified as having Long COVID for preliminary analyses.
We will investigate risk factors for developing Long COVID among the cohort of non-hospitalised individuals with COVID-19 using logistic regression. We will then define unique symptom clusters using unsupervised clustering methods. We will compare clinical characteristics, hospital admissions after 28 days, intensive care unit (ICU) admissions and mortality rates between patients from different symptom clusters.
This work will enable us to define a cohort of patients with confirmed non-hospitalised Long COVID-19 and matched controls who will be subsequently invited to a patient-consented prospective cohort study via their GPs with support from CPRDâs Interventional Research services. The follow-up study will be covered by a separate research ethics approval.
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The clinical and economic burden of antibiotic use among paediatric patients with Varicella infection: a retrospective cohort analysis of real-world data in the UK — Stephanie Kujawski ...
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The clinical and economic burden of antibiotic use among paediatric patients with Varicella infection: a retrospective cohort analysis of real-world data in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-06
Organisations:
Stephanie Kujawski - Chief Investigator - Merck & Co., Inc.
Victoria Banks - Corresponding Applicant - Adelphi Real World
Amisha Patel - Collaborator - Adelphi Real World
Caroline Casey - Collaborator - Adelphi Real World
Christina Diomatari - Collaborator - Adelphi Real World
M.Nabi Kanibir - Collaborator - Merck & Co., Inc.
Manjiri Pawaskar - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Olivia Massey - Collaborator - Adelphi Real World
Tim Holbrook - Collaborator - Adelphi Real WorldOutcomes:
Type and frequency of varicella-related complications; anti-infective and supportive care (emollients, pain medication) treatment patterns including type, dosage and duration; all-cause and varicella-related HCRU; all-cause and varicella related direct medical costs
Description: Technical Summary
Aim: To assess and characterize the use of antibiotics for the treatment and management of varicella and its associated complications in the paediatric population in the UK.
Objectives: i) to describe the demographics and clinical characteristics of paediatric patients diagnosed with varicella within a primary or secondary care setting ii) to describe the type and frequency of varicella-related complications iii) to examine treatment patterns with anti-infective (antibiotic and antiviral) usage iv) to estimate the direct medical costs of antibiotic use for the treatment of varicella infection and associated complications v) to describe for primary and secondary care related to varicella and associated complications, the all cause and varicella-related health care resource utilization (HCRU) and associated direct medical costs.
Primary exposures: physician diagnosis of varicella.
Outcomes: varicella-related complications, anti-infective treatment patterns, HCRU and costs
Methods: A retrospective cohort study of paediatric varicella patients between July 2014 and June 2019 (indexing period), using linked primary and secondary care administrative data. The index date will be defined as the date of the first diagnosis of varicella occurring in primary or secondary care during the indexing period. A minimum of 28 days baseline and 3-months follow-up data post (and including) the index date will be required for inclusion into the study, during which baseline sociodemographic characteristics, clinical characteristics including complications, treatment use patterns and HCRU/ costs will be described.
Data analysis: Counts, means, medians, standard deviation, 25th and 75th percentile values will be reported for numeric variables and relative frequencies, proportions/ percentages for nominal variables. Where applicable, all estimates will be described with accompanying 95% confidence intervals. HCRU and costs will be derived by observing consultations and medications in primary care, and Healthcare Resource Group (HRG) for secondary care.
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Burden of polycystic ovary syndrome during pregnancy and offspring outcomes — Anuradhaa Subramanian ...
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Burden of polycystic ovary syndrome during pregnancy and offspring outcomes
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-26
Organisations:
Anuradhaa Subramanian - Chief Investigator - University of Birmingham
Anuradhaa Subramanian - Corresponding Applicant - University of Birmingham
Astha Anand - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Siang Ing Lee - Collaborator - University of Birmingham
Tom Taverner - Collaborator - University of BirminghamOutcomes:
Outcomes to be measured
⢠Incidence and prevalence trends of PCOS
⢠Incidence and prevalence of type 2 diabetes, prediabetes and gestational diabetes among women with PCOS
⢠Morbidity clusters among pregnant women with PCOS
⢠Common prescriptions among pregnant women with PCOS
⢠Risk of adverse offspring outcomes (miscarriage, stillbirth, neonatal mortality, , gestational diabetes, preterm birth, hypertensive disease in pregnancy, baby birth weight, major congenital abnormalities, and neurodevelopmental disorders) among pregnant women with PCOS compared to women without PCOSDescription: Technical Summary
The aim of this study is to estimate the trends in incidence and prevalence of PCOS within the primary care setting and to understand the PCOS disease burden, especially among pregnant women.
A retrospective cohort study between 1990 and 2020 of all eligible women in primary care aged between 15 and 50 will be conducted to estimate the annual prevalence and incidence rates of PCOS based on PCOS diagnostic codes and a conglomeration of symptom codes employed by various diagnostic criteria. Within the cohort of women with PCOS, incidence and prevalence of pre-diabetes and type 2 diabetes will be estimated.
Using the CPRD Pregnancy Register, cohort of individual pregnancies of women with PCOS will be established.
Latent class analysis (LCA) and Gaussian finite mixture models will be used to identify co-morbidity clusters among pregnant women with PCOS. A list of >90 co-morbidities have been pre-determined through literature search and stakeholder workshop, which will considered for the clustering analysis.Among pregnant women with PCOS, we will then estimate the proportion of pregnancies prescribed with drugs catalogued by BNF chapters. This will be stratified by trimesters of pregnancy.
A retrospective controlled cohort study of pregnant women with and without PCOS matched for age (±1 year) and BMI (± 2 kg/m2) will be conducted to estimate the incidence of 9 harmonized core pregnancy outcome as described in literature: miscarriage, gestational diabetes, hypertensive disease in pregnancy, stillbirth, neonatal mortality, preterm birth, baby birth weight, major congenital abnormalities, and neurodevelopmental disorders.
We will identify risk factors of outcomes within the cohort of pregnancies with PCOS; risk factors considered include age, ethnicity, socio-economic status, androgen excess based on biochemical measurements and symptomatic presentations, pre-diabetes, type 2 diabetes, co-morbidity cluster allocated by cluster analysis technique and common prescriptions observed in the descriptive analysis of prescriptions during pregnancy.
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Validation of query definitions for a new or long-term course of antidepressant medications: a descriptive study. — Craig Grime ...
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Validation of query definitions for a new or long-term course of antidepressant medications: a descriptive study.
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-07
Organisations:
Craig Grime - Chief Investigator - National Institute for Health and Clinical Excellence - NICE
Theresa Jennison - Corresponding Applicant - National Institute for Health and Clinical Excellence - NICE
Charlotte Fairclough - Collaborator - National Institute for Health and Clinical Excellence - NICE
Eleanor Yelland - Collaborator - CPRD
Mark Minchin - Collaborator - National Institute for Health and Clinical Excellence - NICE
Robert Willans - Collaborator - National Institute for Health and Clinical Excellence - NICEOutcomes:
Antidepressant medication prescription
Definition of new courses of antidepressant medication.
Definition of long-term course of antidepressant medication.Description: Technical Summary
The National Institute for Health and Care Excellence (NICE) are commissioned by NHS England to develop indicators which are suitable for inclusion in the Quality and Outcomes Framework (QOF) subject to negotiation between NHS England and the British Medical Associationâs General Practitioners Committee (GPC).
In 2017/18, 7.3 million people were prescribed antidepressants, and 4.4 million of these also received a prescription in either 2015/16 or 2016/17. The NICE guideline on depression in adults (2009) recommends that people prescribed antidepressants for anxiety or depression need early review to monitor improvement and to assess for side effects, with yearly follow up to assess again for side effects.
This study will test the feasibility of using primary care data on antidepressant prescriptions to accurately provide the cohorts necessary for the denominators of the following indicators:
a) The percentage of patients with a new course of antidepressant in the preceding 12 months who have been reviewed not later than 14 days after their first prescription
b) The percentage of patients prescribed a long-term antidepressant who have a record of a medication review in the preceding 12 months.The study will be limited to antidepressant prescriptions between 1 January 2018 and 31 Dec 2020. Two different ways of defining both ânew coursesâ and âlong-term useâ will be used. Resulting patient numbers per practice will be compared against each other, results from existing literature and results from an ePACT2 search to assess concordance and quantify the limitations. ePACT2 is an online application which gives authorised users access to prescription data held by NHS Prescription Services.
The results of this work will be used to assess the validity of the proposed indicators and their suitability for use in the Quality and Outcomes Framework (QOF) to improve the quality of care for patients prescribed antidepressant medication.
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Propensity to order diagnostic blood tests in general practices — Tom Marshall ...
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Propensity to order diagnostic blood tests in general practices
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-14
Organisations:
Tom Marshall - Chief Investigator - University of Birmingham
Rachel Strudwick - Corresponding Applicant - University of BirminghamOutcomes:
The primary outcome is the number of blood tests ordered by general practices.
Description: Technical Summary
There is considerable variation in blood test ordering behaviour between general practices. This variability has been found to be unrelated to the demographic, socioeconomic and case-mix factors of the practice. An alternative explanation is that variation may be explained by personal characteristics of clinicians or cultural characteristics of the general practices in which they work. This study is intended to understand variation in the ordering of diagnostic blood tests.
The study is a retrospective cohort study. Firstly, we will calculate the rate of blood test ordering in general practices and adjust for age, sex, case-mix and deprivation. We will then describe the trends over time to assess to what extent the rate of blood test ordering is and enduring characteristic of the general practice. Next, we will investigate whether there is any correlation of the rates of ordering between different types of test.
Variations in clinical practice have been a topic of interest to health services research for many years. Variations in blood test use have a number of important public health implications. Higher use of some blood tests may result in more rapid diagnosis of illnesses such as cancers and may be associated with better management of long-term conditions. On the other hand, higher use of some blood tests may result in patient harm through cascades of investigations or false positive results. It is therefore important to understand what factors drive higher or lower rates of diagnostic test use in order to investigate further and find out what underlies these variations. This is a first step in investigating whether general practices have distinct cultures or âpersonalitiesâ in relation to their use of diagnostic tests in order to understand what an optimum diagnostic test rate would be and to consider how this might be optimised.
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Preventing stroke, premature death and cognitive decline in a broader community of patients with atrial fibrillation using healthcare data for pragmatic research: A randomised controlled trial (DaRe2THINK) — Dipak Kotecha ...
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Preventing stroke, premature death and cognitive decline in a broader community of patients with atrial fibrillation using healthcare data for pragmatic research: A randomised controlled trial (DaRe2THINK)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-14
Organisations:
Dipak Kotecha - Chief Investigator - University of Birmingham
Alastair Mobley - Corresponding Applicant - University of Birmingham
David Shukla - Collaborator - University of Birmingham
Puja Myles - Collaborator - CPRD
Samir Mehta - Collaborator - University of Birmingham
Susan Beatty - Collaborator - CPRD
Tim Williams - Collaborator - CPRD
Xiaoxia Wang - Collaborator - University Hospitals BirminghamOutcomes:
Primary outcome:
The primary outcome is a composite of cardiovascular mortality, ischaemic cerebrovascular events (stroke and transient ischaemic attacks), all thromboembolic events (including venous and arterial thromboembolism), myocardial infarction and vascular dementia.
Secondary outcomes:
Individual components of the primary outcome; Cumulative event rates for each individual component of the primary outcome; Conventional major adverse cardiovascular events (composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death); Any major bleeding or clinically-relevant non-major bleeding that requires hospitalisation; Minor bleeding that requires attention from primary care (any bleeding that leads to a primary care consultation); Haemorrhagic stroke and other types of intracranial bleeding; All-cause general practice visits; All-cause hospital admissions and duration of stay; Heart failure hospitalisation and duration of stay; All-cause mortality.Description: Technical Summary
DaRe2THINK is a MHRA (CTA 21761/0364/001-0001), and REC (21/NE/0021) approved randomised control trial. This application is seeking approval to link CPRD primary care data with both HES Admitted Patient Care and ONS Death Registration data to revolutionise the way that research is conducted in the NHS. Current RCT methodology often leads to recruitment of highly selected participants with less diversity than the clinical population. New RCT approaches are needed that can realise the value of the world-leading data quality and infrastructure of the NHS.
Atrial Fibrillation (AF) is the most common heart rhythm abnormality, is expected to double in prevalence in the next few decades, and leads to a considerable burden for patients and society at-large. In particular, the impact of stroke, and vascular dementia are all major public health concerns.
DaRe2THINK will test the hypothesis that direct oral anticoagulant (DOACs) are effective and cost-effective in patients with AF at low or intermediate risk of stroke by using an ambitious and innovative data-enabled approach through the Clinical Practice Research Datalink (CPRD) in General Practices across England.
This Individual-patient, open-label, event-driven RCT with 1:1 allocation to DOAC or usual care will run for a total of 60 months. Patient recruitment will last for 24 months and will be conducted through automated screening of over 10million health records found in the CPRD Primary Care database. Participants will be consented, randomised and followed up for 36 months through the linkage of their Primary and Secondary Care data. The primary outcome is a comprehensive composite of any thromboembolic event, including cardiovascular mortality, ischaemic stroke, pulmonary or venous thromboembolism, myocardial infarction and vascular dementia, ascertained entirely using electronic healthcare records within both Primary and Secondary NHS care. We will also assess and validate safety outcomes relating to any change in bleeding risk.
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Epidemiology and burden of Illness of familial hypercholesterolaemia and hypercholesterolaemia in combination with atherosclerotic cardiovascular disease or atherosclerotic cardiovascular disease risk equivalence. — Christopher Morgan ...
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Epidemiology and burden of Illness of familial hypercholesterolaemia and hypercholesterolaemia in combination with atherosclerotic cardiovascular disease or atherosclerotic cardiovascular disease risk equivalence.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-27
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Raquel Lahoz - Collaborator - NOVARTISOutcomes:
Incidence, prevalence, baseline characteristics; incidence of cardiovascular events; cardiovascular mortality;all-cause mortality healthcare utilisation, costs,
Description: Technical Summary
Elevated levels of low density lipoprotein cholesterol (LDL-C) are associated with cardiovascular risk. Reducing LDL-C with lipid-lowering therapies may halt the progression of atherosclerotic plaque and reduce the incidence of cardiovascular events. However, a significant proportion of patients with elevated LDL-C are intolerant, contraindicated or refractory to existing treatments. In clinical trials, inclisiran has shown efficacy in reducing LDL-C. This retrospective, descriptive study aims to use the Clinical Practice Research Datalink to select three cohorts that may benefit from inclisiran: i) atherosclerotic cardiovascular disease (ASCVD), ii) ASCVD-risk equivalent (based on presence of Type 2 diabetes, familial hypercholesterolemia or a baseline Framingham risk score indicative of â¥20% risk of 10-year cardiovascular event), iii) familial hypercholesterolemia. From these pools, those with evidence of hypercholesterolemia based on diagnosis, LDL-C test or prescription of lipid-lowering therapy will form the study cohorts. Index date will be date of first occurrence of a contributory diagnosis or biochemical marker in the study identification period (01/01/2016-31/12/19 for the primary incidence analysis). Cohorts will also be stratified by demographic characteristics, baseline therapy, LDL-C control and statin intolerance. The primary objective is to describe the incidence of these conditions. Secondary objectives are to describe i) prevalence ii) demographics, clinical characteristics and baseline biochemistry lipid lowering regimens iii) incidence of subsequent hospitalisations, mortality, myocardial infarction and stroke and iv) resource use and associated costs. A model will be constructed to predict high-cost patients defined by the upper decile. Linked data from the Hospital Episode Statistics admitted patient care, outpatient and accident and emergency datasets will be used to ascertain exposures and descriptive disease and surgical outcomes and resource use and costs. Office of National Statistics mortality data will provide cardiovascular and mortality outcomes. Index of multiple deprivation data will provide baseline characteristics and as a predictor in the model.
Source - and 21 more projects — click to show
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Characterizing the changing morbidity and cause-specific mortality burden of the obesity epidemic in England and the UK — Edward Gregg ...
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Characterizing the changing morbidity and cause-specific mortality burden of the obesity epidemic in England and the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-14
Organisations:
Edward Gregg - Chief Investigator - Imperial College London
Marisa Sophiea - Corresponding Applicant - Imperial College London
Francesco Zaccardi - Collaborator - University of Leicester
Jonathan Pearson-Stuttard - Collaborator - Imperial College LondonOutcomes:
The outcomes to be measured will be stratified into three tiers of complexity for mortality and morbidity. Tier 1 is the broad category of conditions, Tier 2 includes specific categories of non-communicable diseases, and Tier 3 is cause-specific mortality or morbidity from each group of condition. The ICD-10 chapters and codes in addition to the categories for cause-specific mortality are in Appendix 1 and cause-specific morbidities are in Appendix 2.
Description: Technical Summary
This study aims to advance our understanding of the heterogeneous and changing impact of overweight and obesity, through morbidity and cause-specific mortality, in UK adults.
This will be a dynamic cohort which will estimates the trends in obesity-related morbidity and mortality among overweight and obese adults. The primary exposures of interest will be BMIs which will use continuous BMI measurements to assess non-linear relationships between BMI and mortality/morbidity and categorised BMI using the WHO definitions. The categories will be defined as: normal weight (<25 kg /m2), overweight(BMI 25-29.9 kg/m2) and obesity is a BMI >30 kg/m2, with obesity further subcategorised to account for its severity (class I: 30 to <35, class II: 35 to <40, and class III: >40).
The primary cohort will be individuals with BMIs measured. The outcomes that will be assessed will include the following diseases and conditions: cardiovascular, cancers, respiratory, musculoskeletal, mental, neurological, and endocrine. How these will be categorised and defined are specified in the Appendices, as detailed in the âOutcomes to be Measuredâ section.
The primary analysis will be discrete time-to-event Poisson regression, with age and calendar year as time-dependent covariates. This methodology will show the trends in rates of cause-specific mortality and morbidities, thus the changing rates of mortality from specific causes of death proportional to all-causes in overweight and obese individuals.
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Glycaemic control across ethnicity of insulin-naive type 2 diabetes patients residing in England when initiating Biphasic insulin aspart 30-70 (BIAsp 30) — Uffe Christian Braae ...
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Glycaemic control across ethnicity of insulin-naive type 2 diabetes patients residing in England when initiating Biphasic insulin aspart 30-70 (BIAsp 30)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-27
Organisations:
Uffe Christian Braae - Chief Investigator - Novo Nordisk
Uffe Christian Braae - Corresponding Applicant - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Anders Boeck Jensen - Collaborator - Novo Nordisk
Melanie Davies - Collaborator - University of Leicester
Renuka M - Collaborator - Novo Nordisk
Rikke Baastrup Nordsborg - Collaborator - Novo NordiskOutcomes:
Glycaemic control; weight/BMI; hypoglycaemia
Description: Technical Summary
This study aims to investigate glycaemic control and clinical characteristics in insulin-naïve T2DM patient groups of different ethnic descent e.g. Caucasian, Chinese, Indian, Pakistani living in England, when initiating BIAsp 30. Furthermore, we will investigate the occurrence of hypoglycaemic events and change in weight after initiation of insulin treatment. BIAsp 30 is effective in controlling glycaemic levels in patients with T2DM, however, limited evidence is available describing the use in patients of various ethnic descent in a real-world setting. The study will use a retrospective cohort design, with first time use of BIAsp 30 as index, to assess glycaemic control based on HbA1c prior to index and during a 12-month post-index follow-up period. Mixed model of repeated measures (MMRM) will be used to evaluate mean Hb1Ac levels from baseline to end of follow-up. Identical methodology will be used to examine change in mean weight. The risk of hypoglycaemia will be evaluated based on the number of hypoglycaemia events from 12 months prior index to index compared to the number of events following from index to 12 months post index and analysed using a negative binomial regression model with a log-transformed offset.
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Characterisation of multimorbidity clusters and trajectories using data-driven approaches in a nationally-representative population — Sarah Finer ...
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Characterisation of multimorbidity clusters and trajectories using data-driven approaches in a nationally-representative population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-05
Organisations:
Sarah Finer - Chief Investigator - Queen Mary University of London
Fabiola Eto - Corresponding Applicant - Queen Mary University of London
Alisha Angdembe - Collaborator - Queen Mary University of London
Deborah Swinglehurst - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Michael Barnes - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Miriam Samuel - Collaborator - Queen Mary University of London
Nick Reynolds - Collaborator - Newcastle University
Rafael Henkin - Collaborator - Queen Mary University of London
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sally Hull - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Steph Taylor - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Tahania Ahmad - Collaborator - Queen Mary University of LondonOutcomes:
Primary outcome(s):
(a) The clusters of multimorbidity*; and,
(b) The multimorbidity cluster trajectories throughout the follow up period.*Multimorbidity will be defined as the presence of two or more long-term conditions (out of the clinical consensus-derived 220 conditions described in appendix 1) within the same individual. Unsupervised machine learning algorithms applied to the dataset will then derive and define clusters of multimorbidity, by grouping similar entities together (using an understanding of difference in distance between data points). A sample of code sets used to select conditions are shown in Appendix 2.
Secondary outcomes:
(a) Index condition to multimorbidity cluster; and,
(b) Multimorbidity cluster to deathDescription: Technical Summary
Our proposal seeks to deliver new knowledge on multimorbidity through the application of hypothesis-generating, data-driven analytical tools to a large-scale electronic health record dataset from a nationally-representative population. We seek to expand on previous multimorbidity research (which focuses predominantly on 30-40 common chronic conditions) to define clusters and trajectories of multimorbidity across ~200 long-term conditions. This large set of conditions have been defined through a rigorous consensus-building process and extensive review of existing validated code sets (including previously-published CPRD studies undertaken by CALIBER and the Cambridge Multimorbidity group (1â3)).
We will initiate our analyses using a cross-sectional design, applying data-driven clustering (unsupervised machine learning) to identify clusters of multimorbidity in England population across our extensively-curated ~ 200 long-term conditions obtained from primary care data and linked Hospital Episode Statistics (HES). We will stratify our analysis by ethnicity to identify how multimorbidity clusters across ethnic groups (including White, Black African and Caribbean, and south Asian).
Subsequent to this hypothesis-generating clustering, we will use an observational cohort design to investigate how multimorbidity clusters develop from index conditions and how they change over time, including to death (using linked Office for National Statistics mortality data). At this point, we will focus on a limited number of multimorbidity clusters (up to 8) selected to ensure we generate new knowledge, e.g. clusters which include less-studied conditions such as cancer or human immunodeficiency virus, as well as those where there is variation by ethnicity. We will then use epidemiological analyses, including Cox model, adjusted by socioeconomic characteristics (age, sex, ethnicity, Index of Multiple Deprivation), and time-dependent variables (e.g. risk factors, clinical measurements) to characterise these trajectories. Additionally, we will apply artificial intelligence techniques (including supervised and unsupervised machine learning) for focused analyses to examine the interrelationship between specific multimorbidity clusters under study and prescribing/polypharmacy patterns.
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Mortality and associated risk factors in individuals with and without type 1 and type 2 diabetes: A matched retrospective cohort study. — Bogdan Grechuk ...
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Mortality and associated risk factors in individuals with and without type 1 and type 2 diabetes: A matched retrospective cohort study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-06
Organisations:
Bogdan Grechuk - Chief Investigator - University of Leicester
Bogdan Grechuk - Corresponding Applicant - University of Leicester
Alexander Gorban - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Evgeny Mirkes - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of LeicesterOutcomes:
Outcomes to be measured:
Death;
Incidence of type 2 diabetes.The short answer is: in the mortality analysis the outcome to be measured is death, while in the morbidity analysis the outcome to be measured is probability of developing type 2 diabetes.
In more details, in the mortality analysis, what we will measure/estimate is the probability of death for a diabetes patient and how this probability is affected by factors such as age, gender, smoking status, and all other covariates and risk factors listed in Section "Exposures, Outcomes and Covariates". Also, we will measure/estimate the probability of a non-diabetic person to become diabetic within the next n years, and how this probability is affected by the risk factors.
Description: Technical Summary
This study investigates mortality in individuals with type 1 and type 2 diabetes compared to matched controls without diabetes. Participants will be matched on presence of risk factors, such as age, smoking status, alcohol consumption, body mass index, and other diseases. We will pay special attention to significance of risk factors, separately and in combination. We will also use the control to assess risk factors for progression to type 2 diabetes. Finally, we investigate trends as to how diabetes-related mortality and risk factors have changed over the past 10 years.
We will use a matched cohort study design with three cohorts: Type 1 diabetes, Type 2 diabetes, and controls. After collection of relevant data from CPRD, we will check for outliers, and correct inconsistences. The treatment of missing values requires their classification according to the modern typology of âdark dataâ, finding missing values patterns and corresponding data imputation is the next step. For hypothesis testing, we will use chi-square test, Fisherâs exact test, t-test, KS test, Mann Whitney U test, Yates test, and other tests according to tested hypothesis. For dimensionality reduction and extraction of important features we will combine classical principal component analysis and factor analysis with manifold learning, principal graphs and filament extraction. Some of these technologies were developed with active participation of our team. Original software libraries for these technologies are developed, tested, and applied by different institutions for biomedical data analysis (Institute Curie, Paris, Harvard Medical School, etc.).
We will use a combination of analytical approaches: the descriptive modelling approach will be used to determine the most significant risk factors, while predictive modelling approach will be used to construct the mortality tables.
HES APC and ONS data will be utilised to assess hospital admissions and mortality trends in the three cohorts.
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Variation in mental and physical health of children with long-term conditions or disability and their families: a longitudinal cohort study — Pia Hardelid ...
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Variation in mental and physical health of children with long-term conditions or disability and their families: a longitudinal cohort study
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-07
Organisations:
Pia Hardelid - Chief Investigator - University College London ( UCL )
Ania Zylbersztejn - Corresponding Applicant - University College London ( UCL )
Amalia Wagstaff - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Linda Wijlaars - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Sophie Bennett - Collaborator - University College London ( UCL )Outcomes:
Primary outcomes: Prevalence of LD or ASD in children; Incidence of mental and physical health morbidity in parents and siblings of children with LD or ASD;
Secondary outcomes: Incidence of mental health illness in children with LD or ASD; Mortality in children with LD or ASD; Incidence of contacts with health care services for children with LD or ASD;
Description: Technical Summary
Children with learning disabilities (LD) or autism spectrum disorders (ASD) may have multiple physical and mental health needs, requiring frequent contacts with health care. Caring for a child with LD/ASD can be challenging and a source of stress leading to both mental and physical health problems for parents and siblings. This study aims to determine factors associated with variation in mental and physical health of children with LD/ASD and their families.
First, we will use CPRD linked to HES and ONS mortality to estimate the prevalence of LD, ASD or both in children in England. We will develop a longitudinal cohort of all children and young people (CYP) aged <24 years. We will indicate CYP with a record of LD, associated condition (where â¥50% of cases are likely to have LD) or ASD. We will describe regional, socio-economic and ethnic inequalities in prevalence of LD/ASD.
Second, we will describe variation in incidence of mental health problems, chronic conditions (by group), mortality, interactions with primary and secondary healthcare in children with LD/ASD compared to other children.
Third, we will use mother-baby link to describe incidence of mental health problems, GP consultations, types of chronic conditions and health behaviours related to stress/fatigue in mothers of children with LD/ASD compared to general population. We will define and evaluate the representativeness of sub-cohorts of siblings (indicated via motherâs record) and fathers (indicated using an algorithm based on family number recorded in motherâs record) and we will repeat all analyses for fathers and siblings.
We will use Poisson/negative binomial regression models to determine incidence rate ratios, logistic/log-binomial regression for comparisons of binary outcomes. All models will include demographics, quintile of Index of Multiple Deprivation score, region of residence, ethnic group, number of children in household to assess variation in outcomes by familyâs socio-economic circumstances.
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Impact of the COVID-19 Crisis on Treatments, Natural History, Health Care Resource Utilisation, and Medical Cost in Hypertrophic Cardiomyopathy in England — Carla Zema ...
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Impact of the COVID-19 Crisis on Treatments, Natural History, Health Care Resource Utilisation, and Medical Cost in Hypertrophic Cardiomyopathy in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-08
Organisations:
Carla Zema - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Andreas Ochs - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
- Collaborator -
Carmen Tsang - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Jason Gordon - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Maria Teresa Tome Esteban - Collaborator - St George's, University of LondonOutcomes:
Epidemiology: Proportions of patients in the linked CPRD-HES database with HCM, oHCM, symptomatic oHCM, asymptomatic oHCM, and nHCM in England.;
Treatment history and treatment pattern: Treatment history variables include time to initial treatment after the initial diagnosis, treatment sequence, treatment use (i.e., number and proportion of patients using each class of treatment for each line of therapy), average treatment duration for each line of therapy, and gap time between adjacent lines of therapy. Treatment patterns include the persistence and adherence associated with existing pharmacologic treatments. Lines of treatments will be constructed at the treatment class level (i.e., beta blocker [BB], calcium channel blocker [CCB], disopyramide, combination therapy, SRT [septal myectomy, alcohol septal ablation], cardiac resynchronization therapy [CRT], implantable cardioverter-defibrillator [ICD] insertion, and other procedures [i.e., heart transplant and pacemaker without bradyarrhythmia]). Adherence to pharmacotherapies will be summarized as the proportion of days covered (PDC).
Natural history: The incidence rate of and time to the following clinical conditions will be assessed: acute renal failure, atrial fibrillation/flutter, chest pain, HF, cardiac arrest, stroke, supraventricular tachycardia, ventricular tachycardia, syncope, ventricular fibrillation, and indication of symptomatic oHCM (for patients with asymptomatic diagnosis only). In addition, the following clinical events will be assessed: any hospitalisation, any emergency room (ER) visit, heart transplantation, CRT, ICD placement, SRT, death, and cardiovascular-disease-related (CVD) death.;Health care resource utilisation: Health care resource utilisation outcomes will include the proportions and the incidence rates of primary care contacts (general practice consultations, telephone consultations, home visits, emergency visits, and out-of-hours consultations) and secondary care contacts (hospital inpatient admissions [including length of stay], outpatient visits, day case visits, emergency visits). Specialty visits, blood tests, imaging, and procedures relevant to HCM may also be considered. All-cause health care resource utilisation will be studied. CVD-related resource utilisation may also be studied.
Medical cost: Medical cost outcomes will include mean costs associated with each type of health care resource utilisation, using unit costs for each type of health care resource utilisation obtained from the NHS reference costs and the Personal Social Services Research Unit. All-cause medical costs will be studied. CVD-related medical costs may also be studied.Description: Technical Summary
With the linked CPRD-HES database, patients with HCM and its subtypes (oHCM, symptomatic oHCM, asymptomatic oHCM, and non-obstructive HCM [nHCM]) will be selected using validated codes indicative of diagnoses, symptoms, and procedures. A control cohort of patients with no HCM will be matched with a 3:1 ratio to each case on age, sex, region, and index year.
It is hypothesised that compared with controls, HCM patients had increased risks of developing clinical events and increased health care resource utilisation and medical cost. Additionally, it is hypothesised that the initiation of COVID-19 restrictions in England caused an interruption in HCM treatments, and thereby increased incidences of clinical events, and decreased health care resource utilisation and medical costs, potentially with a larger impact on general practitioner (GP) visits than inpatient admissions.
In the analysis, first, the frequency of HCM and its subtypes will be calculated as a proportion of all patients in the database. Second, treatment history and treatment patterns in HCM will be summarized and compared before vs. after the implementation of the COVID-19 restrictions in England. Third, natural history will be summarized as incidence rates of and time to clinical conditions and events. This will be compared between HCM patients and controls and before vs. after the COVID-19 restrictions. Fourth, health care resource utilisation will be evaluated as the proportions and incidence rates of patients using each type of resource in primary and secondary care. Medical costs will be assessed using unit costs for each type of health care resource utilisation obtained from National Health Service (NHS) reference costs, and applied to the number of visits. Health care resource utilisation and medical costs will be compared between HCM patients vs. controls and before vs. after the COVID-19 restrictions using generalised estimating equation (GEE) models.
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Prediction of which patients with venous thromboembolism may benefit from an extended anticoagulation 3 months post diagnosis — Kevin Pollock ...
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Prediction of which patients with venous thromboembolism may benefit from an extended anticoagulation 3 months post diagnosis
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-21
Organisations:
Kevin Pollock - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Amaia Irizar - Collaborator - Forecom Bioscience Ltd
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Imran Khan - Collaborator - Pfizer Ltd - UK
Mikel Bober - Collaborator - Forecom Bioscience Ltd
Miroslaw Bober - Collaborator - University of Surrey
Satarupa Choudhuri - Collaborator - Not from an Organisation
Stephan Rietbrock - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Susan Miller - Collaborator - Pfizer Ltd - UK
Zbigniew Galias - Collaborator - Forecom Bioscience LtdOutcomes:
VTE recurrences (R-VTE); major bleeding and clinically-relevant non-major bleeding requiring hospitalization (CRNMB-H).
Description: Technical Summary
Venous thromboembolism (VTE) which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE) is a common cause of morbidity and mortality. Many guidelines divide the anticoagulation (AC) therapy of VTE into various phases of treatment following the initial diagnosis, the acute phase for the first 1-2 weeks, the long-term treatment phase for 3-6 months, and the extended phase after the first 3-6months. Treatment duration is mainly based upon the risk of recurrence of VTE (R-VTE). The recommendation is that patients receive at least 3 months of anticoagulation. Patients at high risk of recurrence are offered extended anticoagulation. The risk of bleeding, unless very high, is not usually a major part of that calculation. Bleeding risks are considered separately and are loosely based on accumulating risks from data derived in both VTE and atrial fibrillation patients. Currently, insufficient data exist to support the integration of bleeding risk into duration of therapy planning and a combination of clinical insight, patient prothrombotic factors and patient choice informs anticoagulation duration.
An approach that allows clinicians to determine the duration of therapy right from the outset, and updates as new risks appear, as opposed to making the decision at a second consultation at 3 or 6 months, could render better treatment planning and patient education, as well as freeing up the clinic appointment time slots for other cases and be cost effective at the same time.
We aim to use baseline and time variable data in undertaking standard and machine learning methodology to develop and evaluate a novel risk prediction algorithm. Our algorithm will estimate risks of R-VTE and Clinically Significant Bleeding (CSB) in two scenarios: with AC continuation and with AC discontinuation, and thus may help clinicians in their decisions to determine which DVT & PE patients to place on extended AC.
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Completeness and representativeness of ethnicity data in the UK Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) — Eleanor Axson ...
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Completeness and representativeness of ethnicity data in the UK Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES)
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-14
Organisations:
Eleanor Axson - Chief Investigator - CPRD
Eleanor Axson - Corresponding Applicant - CPRD
Helen Booth - Collaborator - CPRD
Karen Cuenco - Collaborator - The Gates Foundation
Mia Harley - Collaborator - CPRD
Preveina Mahadevan - Collaborator - CPRD
Rebecca Ghosh - Collaborator - CPRD
Suhail Shiekh - Collaborator - CPRDOutcomes:
Proportion of patients in CPRD with a usable ethnicity recorded in CPRD and/or linked HES
Agreement of ethnicity recordings in CPRD for patients with multiple records
Agreement of ethnicity recordings in HES for patients with multiple records
Agreement of ethnicity recordings between CPRD and HES
Representativeness of ethnicity in CPRD and linked HES compared to the general populationDescription: Technical Summary
This study will be a retrospective cohort study of completeness and representativeness of the ethnicity recording in the Clinical Practice Research Datalink (CPRD) GOLD and Aurum databases. Additionally, ethnicity recoding in English secondary care, from the Hospital Episode Statistics (HES), will be linked to English patients in CPRD GOLD and CPRD Aurum for a more complete picture of the completeness and representativeness of ethnicity.
Firstly, we will assess the completeness of ethnicity data in CPRD and in CPRD linked with HES by determining the proportion of patients with ethnicity recorded. We will assess the completeness of ethnicity recording annually in each database. This is because from 2006-2011, the Quality and Outcomes Framework incentivised ethnicity recording in primary care. Secondly, we will assess the agreement of ethnicity recordings in patients who have multiple recordings in CPRD, in HES, and in CPRD combined with HES. Finally, we will assess the representativeness of ethnicity distribution in CPRD and CPRD combined with HES compared with the ethnicity distributions from the 2011 Census in the United Kingdom, Great Britain, England, Scotland, Wales, and Northern Ireland.
This project will benefit patients and researchers by providing up-to-date information on this important demographic variable including the completeness, usability, limitations, and representativeness of ethnicity in CPRD and HES to inform choice of data sources, interpretation of results, and translation of those results into practice for patients.
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Risk of fractures in cancer survivors in the United Kingdom: a population-based matched cohort study using linked electronic health records databases — Krishnan Bhaskaran ...
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Risk of fractures in cancer survivors in the United Kingdom: a population-based matched cohort study using linked electronic health records databases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-22
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Eva Buzasi - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Garth Funston - Collaborator - University of Cambridge
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The primary outcome is bone fracture. Secondary/exploratory outcomes are major osteoporotic fractures, and diagnosed osteoporosis.
Description: Technical Summary
Over the past decades, advances in cancer detection and treatment have resulted in improved survival, whilst raising concerns about long-term adverse consequences. It has been suggested that people receiving cancer therapy may experience higher rates of bone loss, osteoporosis and bone fracture. However, there is currently little population-based evidence on this. The relationship between cancer survival and bone health is important to understand considering the high burden of morbidity and mortality associated with fracture and consequent reduced quality of life, in addition to the substantial financial costs to the health service.
Our matched cohort study will use data from CPRD GOLD and Aurum primary care databases and linked Hospital Episodes Statistics (HES) admitted patient care data to identify cancer survivors and age/sex/GP-matched controls. Linked ONS mortality data will be used to censor deaths. We will describe the incidence of fracture and osteoporosis in cancer survivors (ascertained using primary care and linked HES data). We will use Cox regression analysis to compare the risk of bone fracture in individuals with a history of cancer (stratified by cancer site) to matched controls with no history of cancer. Linked patient-level deprivation data will allow adjustment for socioeconomic deprivation. We will also assess whether the association between having a history of cancer and developing adverse bone health outcomes changes with key individual-level factors.
The study will help to identify whether some, or all, cancer survivors are at higher risk of developing bone problems, will help health services target interventions to prevent fractures, and will help identify priority areas for more detailed research on how specific cancers can lead to poor bone health.
Source -
Completeness and representativeness of small area socioeconomic data linked with the UK Clinical Practice Research Datalink (CPRD) — Eleanor Axson ...
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Completeness and representativeness of small area socioeconomic data linked with the UK Clinical Practice Research Datalink (CPRD)
Datasets:GP data, - Completeness of patient-level SES/RUC measures in CPRD for England and English regions, and completeness of practice-level SES/RUC measures in CPRD across the UK
- Agreement and correlation of patient- and practice-level SES/RUC in CPRD for England and English regions
- Correlation of different SES measures in CPRD at the patient-level for England and English regions, and at the practice-level across the UK
- Agreement of SES, age and sex distribution with the general UK, GB, and country populationsProcessing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-29
Organisations:
Eleanor Axson - Chief Investigator - CPRD
Eleanor Axson - Corresponding Applicant - CPRD
Helen Booth - Collaborator - CPRD
Karen Cuenco - Collaborator - The Gates Foundation
Mia Harley - Collaborator - CPRD
Preveina Mahadevan - Collaborator - CPRD
Rebecca Ghosh - Collaborator - CPRD
Susan Hodgson - Collaborator - CPRDOutcomes:
- Completeness of patient-level SES/RUC measures in CPRD for England and English regions, and completeness of practice-level SES/RUC measures in CPRD across the UK
- Agreement and correlation of patient- and practice-level SES/RUC in CPRD for England and English regions
- Correlation of different SES measures in CPRD at the patient-level for England and English regions, and at the practice-level across the UK
- Agreement of SES, age and sex distribution with the general UK, GB, and country populationsDescription: Technical Summary
This study will be a retrospective cohort study of completeness and representativeness the area level socioeconomic (SES) and Rural-Urban Classification (RUC) data linked with the Clinical Practice Research Datalink (CPRD) GOLD and Aurum databases, amongst acceptable patients and currently registered patients eligible for patient postcode linkage. SES/RUC data linked with CPRD can be provided at the practice-level across the UK, and at the patient-level for England only. Currently, CPRD offers linkage with the Indices of Multiple Deprivation (IMD), the Townsend Deprivation Index, the Carstairs Index, and RUC, which are commonly used in health research as a proxy for individual level SES in analyses.
Firstly, we will assess the completeness of SES/RUC data linked to CPRD primary care data by determining the proportion of patients and practices with SES data available and the characteristics related to SES/RUC recording. Secondly, we will assess the agreement and correlation of patient- and practice-level SES/RUC measures to explore whether the practice-level measures can be used as a proxy for the patient level measure where this is missing. Thirdly, we will assess the correlation between the various patient-level SES metrics for patients in England , to ascertain the likely impact of choice of area-based SES measure on interpretation. Finally, we will assess the representativeness of each SES measure in CPRD compared with the general populations of the England (at patient- and practice-level), and the United Kingdom, Great Britain, Scotland, Wales, and Northern Ireland (practice-level only), as well as assessing the representativeness of the CPRD populations by age and sex.
This project will serve patients and researchers by providing up-to-date information on these important demographic variables including their completeness, usability, limitations, and representativeness of SES linkages in CPRD to inform choice of data sources, interpretation of results, and translation of those results into practice for patients.
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Estimating national and local prevalence of severe mental illnesses (SMI) and personality disorders (PD) in England: an exploratory study — Gabriele Price ...
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Estimating national and local prevalence of severe mental illnesses (SMI) and personality disorders (PD) in England: an exploratory study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-07
Organisations:
Gabriele Price - Chief Investigator - Office for Health Improvement and Disparities
Gabriele Price - Corresponding Applicant - Office for Health Improvement and Disparities
Alex Stirzaker - Collaborator - NHS England
Cam Lugton - Collaborator - Office for Health Improvement and Disparities
Danny Yip - Collaborator - Office for Health Improvement and Disparities
David Osborn - Collaborator - UCL Division of Psychiatry
Hannah Walke - Collaborator - Office for Health Improvement and Disparities
Hiral Mehta - Collaborator - Office for Health Improvement and Disparities
James Kirkbride - Collaborator - University College London ( UCL )
Joseph Hayes - Collaborator - University College London ( UCL )
Louis Thackray - Collaborator - Office for Health Improvement and Disparities
Matthew Wickenden - Collaborator - NHS England
Thomas Bardsley - Collaborator - NHS EnglandOutcomes:
The study will calculate the prevalence for -
⢠Patients with SMI (with or without PD)
⢠Patients with PD (with or without SMI)Primary outcomes: Point prevalence of SMI and PD (overall and sub-conditions) in England; point prevalence of SMI and PD by age, gender, ethnicity and deprivation in England; estimated local prevalence of SMI and PD for Clinical Commissioning Groups (CCGs) and Upper Tier Local Authority (UTLAs).
Secondary outcomes: Point prevalence of SMI and PD in England by combination of deprivation quintiles, age groups, gender and ethnicity groups for local estimates purpose
Description: Technical Summary
People with severe mental illness (SMI) have reduced life expectancy and are at increased risk of physical health comorbidities compared to the general population. Recorded prevalence of SMI, as seen on GP registers is reported to be 0.93%. However, the register does not provide prevalence breakdowns by demographic and socio-economic which are proven to affect prevalence of SMI. There is no national register for people with personality disorders (PD). As reported in the 2014 Annual Psychiatry Morbidity Survey, the prevalence of people positively screened for Borderline Personality Disorder was 2.4% and for Antisocial Personality Disorder 3.3% .
Evidence suggest that the local recorded prevalence of SMI is an underestimate, and for PD local estimates are not available.
Factors such as age, gender, ethnicity and deprivation are suggested to affect prevalence of SMI. With PD, there is some evidence suggesting that age, gender and ethnicity affect its prevalence.The purpose of this study is to explore the use of national prevalence of SMI and PD to calculate local prevalence estimates in England. This will primarily be an exploratory study, underpinned by both descriptive and methodological approach. It will calculate point prevalence at England level for people with SMI and PD overall, and by conditions sub-groups and the above variables.
We will run a multivariate logistic regression model to confirm which variables in our model significantly affect the prevalence of these conditions. Finally, we will use a synthetic estimate approach to derive local prevalence estimates. This approach will use the calculated national prevalence by variables and apply it to the local population to calculate estimated prevalence counts and proportions. This study will provide improved local prevalence estimates of SMI and new estimates of PD to support needs based planning and commissioning of services for people with SMI and PD.
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The safety of proton pump inhibitors in children with gastroesophageal reflux disease — Samy Suissa ...
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The safety of proton pump inhibitors in children with gastroesophageal reflux disease
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-26
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Claire Lefebvre - Collaborator - University Of Montreal
Joseph Delaney - Collaborator - University of Manitoba
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Reem Masarwa - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
Primary: Iron-deficiency anemia
Secondary: Vitamin B12 deficiency, gastroenteritis, inflammatory bowel disease
Description: Technical Summary
The high prevalence of GER/GERD in children is becoming increasingly recognized. These conditions produce a variety of symptoms, including regurgitation, abdominal pain, and respiratory symptoms that can affect the quality of life of children and their parents. PPIs are acid suppressing drugs that are commonly prescribed for the management of GER/GERD among children. However, limited evidence is available regarding their effectiveness and safety among pediatric patients. A limited number of clinical trials have examined their safety; however, these studies were conducted in small numbers and only examined short-term outcomes.
We will conduct a population-based, retrospective cohort study using CPRD Aurum, linked to Hospital Episodes Statistics Admitted Patient Care data. We will include infants and children aged 6 months to 18 years with a diagnosis of GER/GERD between January 1998 to June 2019. Our primary objective is to compare rates of iron-deficiency anemia among children with GER/GERD currently exposed to PPIs to that of children currently exposed to H2 RAs. Our secondary objectives are to assess 1) the risk of the vitamin B12 deficiency with PPIs versus H2 RAs among children with GER/GERD; 2) the risk of gastroenteritis with PPIs versus H2 RAs among children with GER/GERD; 3) the risk of inflammatory bowel disease with PPIs versus H2 RAs among children with GER/GERD; 4) the risk of outcomes of interest with PPI users versus unexposed children; and 5) the patterns of PPIs prescribing. We will create a cohort of children with incident GER/GERD during the study period. We will classify the cohort members according to their exposure status: 1) exposed to PPIs; 2) exposed to H2 RAs; 3) not-exposed. Cox proportional hazards models with covariates will be used to estimate hazard ratios and 95% confidence intervals. Extensive sensitivity analyses will be performed.
Source -
Multimorbidity and lipid response to statins: a cohort study — Joe Kai ...
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Multimorbidity and lipid response to statins: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-28
Organisations:
Joe Kai - Chief Investigator - University of Nottingham
Mohana Ratnapalan - Corresponding Applicant - University of Nottingham
Caroline Mitchell - Collaborator - University of Sheffield
Nadeem Qureshi - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Short-term outcomes: 2-year reduction in lipid level by total cholesterol; LDL-C; non-HDL C.
Long-term outcomes: first major adverse cardiovascular events (MACE) endpoints; and all-cause mortality; hospitalisation; GP visits.
Description: Technical Summary
Background and aims: Statins reduce lipid levels, which helps modify the risk of cardiovascular morbidity and death. However, there is variability in lipid response and there is some evidence that the reason for this may be modifiable. Given the growing prevalence of multimorbidity (two or more physical or mental health condition) in the population we aim to understand if this has an influence on lipid response to statins. This study aims to explore which groupings of conditions may be most important to managing lipid levels and preventing future cardiovascular disease.
Methods: We will undertake a prospective cohort study using the CPRD database of all patients started on statin therapy (those with pre-existing cardiovascular disease will be excluded). The exposure groups will be pre-specified common multimorbidity clusters in patients with cardiovascular disease, identified from the literature, which may influence lipid response and/or cardiovascular disease risk. We will use 20 clusters across 4 age-strata as described by Zhu et al (1) and additionally incorporate key statin drug interactions as agreed by 3-4 clinicians. The baseline unexposed group will be those without any identified pre-existing conditions.
Outcomes: Short-term outcomes will be 2-year reduction in lipid level by total cholesterol, LDL-C or non-HDL C. Long term outcomes will use a composite of first major adverse cardiovascular events (MACE) endpoints; all-cause mortality, and proxy measures of health service utilisation (hospitalisation and GP visits).
Statistical analysis: Association between pre-specified multimorbidity clusters and lipid response will be assessed using multivariate logistic regression. Cox proportional hazards model will be used to assess the association between the same multimorbidity clusters and future MACE. Both analyses will be adjusted for baseline CVD risk factors, sex and other potential confounders. Informative censoring of survival time will be taken into account by considering patients who have died or left the practice. A further competing-risk analysis for cause-specific (or sub-) hazard ratio (HR) will be used to calculate the cumulative incidence of the CVD outcomes of interest.
Source -
Predictors and outcomes of traumatic brain injury (concussion) in children — Theresa Redaniel ...
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Predictors and outcomes of traumatic brain injury (concussion) in children
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-04-11
Organisations:
Theresa Redaniel - Chief Investigator - University of Bristol
Joni Jackson - Corresponding Applicant - University of Bristol
- Collaborator -
Aimee White - Collaborator - University Hospitals Bristol NHS Trust
Jelena Savovic - Collaborator - University of Bristol
Jo Williams - Collaborator - University of Bristol
Julie Mytton - Collaborator - University Of the West of England
Karina Gosalia - Collaborator - University of Bristol
Lauren Scott - Collaborator - University of Bristol
Mark Lyttle - Collaborator - University Hospitals Bristol NHS Trust
Matthew Booker - Collaborator - University of Bristol
Rebecca Wilson - Collaborator - University of Bristol
Sharea Ijaz - Collaborator - University of BristolOutcomes:
Outcome 1: Prevalence of TBI in infants <1 year old, and the subset which are coded as abusive or have associated domestic abuse codes, in CRPD and HES datasets (see Appendix A for TBI and AHT codes);
Outcome 2: Predictors of abusive head trauma in infants <1 year old: The outcome of interest is abusive head trauma (see Appendix A for TBI and AHT codes);
Outcome 3: Predictors of TBI in children aged 1-17 years. The outcome of interest is TBI (see Appendix A for TBI and AHT codes);
Outcome 4: Predictors for post-concussion syndrome in children aged 1-17 years following a TBI: The outcome of interest is post-concussion syndrome (see Appendix B for PCS codes).
Description: Technical Summary
Traumatic brain injury (TBI) is the leading cause of death and disability in people aged 1-40 years in the UK. In England and Wales, 1.4 million people attend emergency departments after head injuries annually. Approximately 5-700,000 of these are under 15 years old.
TBI can cause long term problems for the individual, including post-concussion syndrome (PCS). This may be particularly detrimental in children and their families.
Abusive head trauma (AHT) describes deliberately inflicted head injury, causing underlying brain injury. This may be from a direct blow, or shaking (shaken baby syndrome). This preventable condition is the commonest major injury in children under 6 months.
This projectâs overall objective is to investigate predictors and outcomes of TBI in children. We will use HES APC and A&E to identify children suffering AHT and those with PCS. ONS mortality data will be used to identify deaths. Patient level IMD will be used to determine socioeconomic position. For children under 1 year old, who are particularly at risk of AHT, we will fit conditional logistic regression models to investigate predictors for AHT. For children aged 1-17, we will use conditional logistic regression to investigate predictors of TBI and Cox Proportional Hazards models to determine predictors of PCS.
The results will help clinicians identify children at risk of AHT, TBI, or developing PCS following concussion, enabling them to put measures in place to reduce risk and improve outcomes for these children. These findings will inform primary prevention (i.e. before the event occurs). Understanding the prevalence, risk factors, and outcomes of TBI can also guide secondary prevention (e.g. more intensive monitoring of patients in at risk group may help identify events promptly where primary prevention did not occur) and tertiary prevention (e.g. better understanding the long term effects of these events, particularly in terms of PCS).
Source -
ID 127. Ethnicity and Deaths — Brent Council...
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ID 127. Ethnicity and Deaths
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: Brent Council
Description: Brent.
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ID 123. Extension Request: Defining and Improving Access to Secondary Care for Venous Leg Ulcer Patients — Imperial College London...
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ID 123. Extension Request: Defining and Improving Access to Secondary Care for Venous Leg Ulcer Patients
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Chronic Venous Disease in NWL.
Source -
ID-115: Utilisation of real-world evidence in profiling the efficacy and
safety for Ustekinumab (Stelara) in treating IBD patients in
North West London — Imperial College London... see moreID-115: Utilisation of real-world evidence in profiling the efficacy and
safety for Ustekinumab (Stelara) in treating IBD patients in
North West LondonLegal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Inflammatory bowel disease.
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ID-116: Extension Request: Quality of secondary prevention following percutaneous coronary interventions — Royal Brompton & Harefield Hospitals NHS Trust...
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ID-116: Extension Request: Quality of secondary prevention following percutaneous coronary interventions
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: Royal Brompton & Harefield Hospitals NHS Trust
Description: Cholesterol levels.
Source -
ID 125. Extension Request: Characterizing and Preventing Multimorbidity in NW London — Imperial College London...
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ID 125. Extension Request: Characterizing and Preventing Multimorbidity in NW London
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multi-morbidity in North West London that stem from diabetes, pre-diabetes, hypertension, and depression.
Source -
ID-117: Extension Request: Metformin study — West London NHS Trust...
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ID-117: Extension Request: Metformin study
Legal basis:Research – retrospective study
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Antipsychotics.
Source -
ID 124. Extension Request: Impact of organisational models in general practice on patient safety and associated costs — Imperial College London...
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ID 124. Extension Request: Impact of organisational models in general practice on patient safety and associated costs
Legal basis:PhD Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: North West London.
Source
2021 - 03
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Understanding the Impact of Educational Interventions Beyond Test Scores — unknown...
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Understanding the Impact of Educational Interventions Beyond Test Scores
Where: unstated
When: 2021-3-16
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project, being conducted by the Behavioural Insights Team (BIT) and funded by ADR UK, will use linked data to establish whether programmes intended to boost childrenâs educational attainment also have a positive impact on other related outcomes, such as a childâs likelihood of dropping out of school.
To do this, BIT will analyse a dataset linking educational interventions funded by the Education Endowment Foundation (EEF) to other outcomes recorded in sources such as the National Pupil Database (NPD) . As well as addressing specific questions about the impact of educational interventions beyond test scores, the project will help inform how linked administrative data can be used to more robustly evaluate government-funded programmes across other departments and policy areas. This will help ensure tax-payersâ money is spent effectively, in line with the UK Governmentâs renewed focus on robust evidence as signaled by the announcement of its new Evaluation Task Force.
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Vaccination data
Demographics (Aggregate (small numbers supressed)) (Secondary Uses) — Local Authorities...
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To understand the vaccination progress across the SPL patients. — IG-00613_4
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care Public Health England NHS England/Improvement CCGs and CSUs NHS Trusts and GP Practices Ministry of Housing, Communities and Local Government
Approval Date: 02/03/2021
Purpose for which the data is being used: To understand the vaccination progress across the SPL patients.
Dataset: Vaccination data Demographics
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Vaccination data (Aggregate) (Secondary Uses) — Public Health England...
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To present national and site level data to allow for its use in rolling out the vaccine programme and improving the quality of the data. — IG-02343
Recipient Data Controller Organisation(s) : Public Health England NHS England / Improvement Clinical Commissioning Groups (CCGs) GP Practices
Approval Date: 30/03/2021
Purpose for which the data is being used: To present national and site level data to allow for its use in rolling out the vaccine programme and improving the quality of the data.
Dataset: Vaccination data
Category of Data: Aggregate
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data.
Source -
Demographics (Identifiable) (Direct Care) — NHS England...
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Dissemination of PDS data to NHS England associated with rectification of data quality issues in NHS England Vaccine Event Records. There are a number of vaccination records with known data quality issues. A tool has been created to correct these records and disseminate them through existing and approved data pipelines i.e. to NIMS. — IG-02903
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 11/03/2021
Purpose for which the data is being used: Dissemination of PDS data to NHS England associated with rectification of data quality issues in NHS England Vaccine Event Records. There are a number of vaccination records with known data quality issues. A tool has been created to correct these records and disseminate them through existing and approved data pipelines i.e. to NIMS.
Dataset: Demographics
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - legal obligation GDPR Article 9(2)(g) - substantial public interest, plus DPA18 Part 2 Schedule 1 para 6 - statutory and governmental purpose
Statutory Authority: NHSD COPI Notice and COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) - legal obligation GDPR Article 9(2)(g) - substantial public interest, plus DPA18 Part 2 Schedule 1 para 6 - statutory and governmental purpose
National Data Opt-out Applied: Not Applied - Direct Care and legal obligation overrides.
Source -
NHS Pathways
Hospital Episode Statistics (HES)
Emergency Care Data Set (ECDS) (Aggregate (small numbers supressed)) (Secondary Uses) — NHS England/Improvement...
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NHS England is currently implementing the 111 First initiative and requires this data to: i) evaluate the changes implemented and ii) provide evidence to improve service design. — IG-00840_7
Recipient Data Controller Organisation(s) : NHS England/Improvement
Approval Date: 02/03/2021
Purpose for which the data is being used: NHS England is currently implementing the 111 First initiative and requires this data to: i) evaluate the changes implemented and ii) provide evidence to improve service design.
Dataset: NHS Pathways Hospital Episode Statistics (HES) Emergency Care Data Set (ECDS)
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(1) Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: Legal Obligation â Covid-19 Direction to disseminate
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Demographics - NHS Number (Identifiable) (Direct Care and Secondary Uses) — NHS England / Improvement...
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To support the vaccination roll-out across the secure and detained estate by enabling NHS England to centrally co-ordinate the ordering of vaccines and validate the different cohorts of patients to prevent wastage. Monitor who receives a vaccination within this particular population which will include monitoring of uptake by gender and ethnicity. — IG-02230
Recipient Data Controller Organisation(s) : NHS England / Improvement
Approval Date: 25/03/2021
Purpose for which the data is being used: To support the vaccination roll-out across the secure and detained estate by enabling NHS England to centrally co-ordinate the ordering of vaccines and validate the different cohorts of patients to prevent wastage. Monitor who receives a vaccination within this particular population which will include monitoring of uptake by gender and ethnicity.
Dataset: Demographics - NHS Number
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care and Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes GDPR Article 9(2)(i) â Public health DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes DPA 2018 Part 1 Schedule 1 para 3 â Public health
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes GDPR Article 9(2)(i) â Public health DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Shielded Patient List (SPL) (Identifiable) (Secondary Uses) — Public Health England...
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To monitor the effectiveness, safety and coverage of the vaccines programme. — IG-02321
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 25/03/2021
Purpose for which the data is being used: To monitor the effectiveness, safety and coverage of the vaccines programme.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: COPI Regulations
Common Law Duty of Confidentiality: COPI Regulations
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(i) â Public health DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Not Applied â Legal obligation overrides & in Public Interest.
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Ethnic differences in healthcare utilisation and care quality among people with multiple conditions — Mai Stafford ...
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Ethnic differences in healthcare utilisation and care quality among people with multiple conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-01
Organisations:
Mai Stafford - Chief Investigator - The Health Foundation
Mai Stafford - Corresponding Applicant - The Health Foundation
Brenda Hayanga - Collaborator - University of Sussex
Catherine Saunders - Collaborator - University of Cambridge
Jay Hughes - Collaborator - The Health Foundation
Laia Becares - Collaborator - University of Sussex
Yannis Kotrotsios - Collaborator - The Health Foundation
Outcomes: Outcomes of interest will be derived from CPRD and linked HES and ONS Death registration data. Multimorbidity is not limited to physical health conditions and can also include mental health conditions. Previous work highlights depression and severe mental health among the most common conditions diagnosed first in people with multiple long term health conditions (3). We will, therefore, include use of mental health care as well as overall care use in our investigations.
Outcomes capturing multimorbidity level and type:
ï§ Whether patient has two or more conditions
ï§ Number of conditions
ï§ Whether patient has complex multimorbidity (with conditions in more than one body system)
Outcomes capturing care utilisation:
ï§ Number of primary care consultations
ï§ Number of prescribed products (total and psychiatric products)
ï§ Number of immunisations administered
ï§ Number of medical tests requested
ï§ Number and duration of hospital admissions (total and mental-health related)
ï§ Number of outpatient visits (total and mental-health related);
ï§ Number of emergency department visits (total and mental-health related)
Outcomes that may indicate aspects of care quality:
ï§ Continuity of care in primary care
ï§ Number of hospital admissions for an ambulatory care sensitive condition
ï§ 30-day hospital readmission
ï§ All-cause mortalityDescription: Lay Summary
In the UK, the number of people living with multiple long-term conditions is rising. This is concerning because those with multiple conditions have higher treatment burden, reduced quality of life and higher risk of mortality. It also has serious implications for the NHS because of the link between multiple conditions and use of primary and secondary care services.
Technical Summary
Local studies suggest that people from minoritised ethnic groups have a greater risk of multiple long-term conditions than the white majority population. Many have faced experiences of racial discrimination and socioeconomic disadvantage throughout life. These experiences likely increase their risk of multiple conditions. They are also more likely to develop multiple conditions at a younger age. Further, stark ethnic inequalities in COVID-19 infection and mortality have been documented by the ONS, with pre-existing conditions being one of the contributing factors to this. Despite this, there is an incomplete picture of ethnic differences in the prevalence, healthcare utilisation and care quality for people with multiple conditions in the UK.
This study aims to provide novel information on ethnic inequalities in healthcare utilisation and quality in people with multiple conditions and some of the factors that may underlie these inequalities. It also seeks to illuminate ethnic differences in changes in healthcare utilisation since the start of the pandemic. The findings will contribute to the evidence base to inform health system leads about the care needs of minoritised ethnic group populations and highlight where care could be improved, and ethnic inequalities addressed.This study aims to
ï§ Provide an up-to-date description of how multiple conditions vary across ethnic groups in the UK;
ï§ Describe ethnic differences in healthcare utilisation and indicators of care quality for people with multiple conditions before the pandemic;
ï§ Describe ethnic differences in healthcare utilisation during the pandemic compared with 3-year average.
It uses CPRD data from 2016 to examine multiple conditions diagnosed in primary care, by ethnic group. Multimorbidity is defined as the presence of two or more long-term conditions likely to lead to poor quality of life, significant need for treatment or greater risk of premature death (1,2). Level (number of conditions) and type of multimorbidity (e.g. complex multimorbidity) will be considered.
To estimate the prevalence of multimorbidity by ethnic group, sex, age and socioeconomic deprivation, linked ONS IMD data will be used. To examine the full patient pathway, linked HES data on Admitted patient care, Outpatient care and Accident and Emergency and ONS mortality data care will be used.
Number of primary and secondary care visits by ethnicity will be estimated in poisson regression models (or logistic regression models for rarer outcomes). Models will sequentially adjust for i) sex and age, ii) indicators of need for health care (number of long-term conditions, combination of conditions and time since onset of multimorbidity), and iii) indicators of social need (area deprivation quintile). Given the structural inequalities leading to an association between ethnic minority status and deprivation within the UK, deprivation is included as a possible mediating factor. Where sample size allows, inequalities in healthcare at the intersection of gender, age and ethnicity will be modelled.
The main analysis will use pre-pandemic data (to end December 2019). Utilisation by ethnic group during and pre-pandemic will also be estimated in regression models.
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Temporal trends in the incidence of common mental disorders in the United Kingdom by sociodemographic group (2000-2020) — David Osborn ...
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Temporal trends in the incidence of common mental disorders in the United Kingdom by sociodemographic group (2000-2020)
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-03
Organisations:
David Osborn - Chief Investigator - UCL Division of Psychiatry
Jennifer Dykxhoorn - Corresponding Applicant - University College London ( UCL )
Annie Jeffery - Collaborator - University College London ( UCL )
Antonio Lazzarino - Collaborator - University College London ( UCL )
Kate Walters - Collaborator - University College London ( UCL )
Shamini Gnani - Collaborator - Imperial College LondonOutcomes:
Incidence and prevalence of recorded depression, anxiety, and self-harm and related treatment (including pharmacotherapy):
anxiety diagnosis; anxiety symptoms; depression diagnosis; depressive symptoms; self-harm behaviours; receipt of drug treatment for mental disorders (e.g. antidepressants); receipt of psychological therapy; referral to psychotherapyDescription: Technical Summary
Common mental disorders (CMD) are highly prevalent mental health conditions, affecting 10% of the UK population. Research has shown that rates of CMD are linked to socioeconomic difficulty, including unemployment, poverty, and housing insecurity. The last decades have been characterised by dramatic changes in spending in social services, housing, welfare, and the public sector. The financial crisis of 2007-2008 was followed by strict austerity policies, which have differentially affected the most vulnerable people in the UK, entrenching poverty, and contributing to growing inequality.
While poverty and inequality have been consistently linked to poor health outcomes, the impact of austerity policies on mental health has not been specifically determined. Before we are able to examine the impact that austerity policies have on mental health outcomes, we must first establish a better understanding of the incidence of common mental disorders over the past 20 years, with a particular focus on the population subgroups that may be differentially impacted by these changes.
The aim of this research is to estimate the annual incidence of common mental disorders (CMD) from 2000-2020 and to generate age, sex, region, ethnicity, comorbidity, and deprivation-specific incidence estimates, which will allow us to explore inequalities in rates of CMD by sociodemographic factors. We will use CPRD diagnoses and drug prescriptions for anxiety, depression, and self-harm as our primary outcomes. Where possible, we will then use stratum-specific estimates to explore how changes in CMD incidence over time may be linked to macrosocial changes and policy interventions.
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The use of locum doctors in the UK National Health System (NHS): understanding and improving the safety and quality of care — Kieran Walshe ...
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The use of locum doctors in the UK National Health System (NHS): understanding and improving the safety and quality of care
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Kieran Walshe - Chief Investigator - University of Manchester
Christos Grigoroglou - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Gemma Stringer - Collaborator - Not from an Organisation
Jane Ferguson - Collaborator - University of Manchester
Thomas Allen - Collaborator - University of ManchesterOutcomes:
⢠Patients revisiting the general practice within 7 days or 15 days
⢠Referrals to secondary care (from CPRD GOLD)
⢠Unplanned hospital admissions within 7 days or 15 days (HES linkage)
⢠A&E attendance within 7 days or 15 days (HES linkage)
⢠Ambulatory care sensitive conditions (ACSC) hospitalisations within 7 days or 15 days (HES linkage)
⢠Antibiotics prescriptions
⢠Strong Opioid prescriptions
⢠Hypnotics prescriptions
⢠Validated prescribing safety indicators (STOPP/START criteria, PINCER indicators)Description: Technical Summary
The aim of the study will be to collect and analyse quantitative data sets to compare the working patterns and performance of locums to those of other GP types in primary care. We will use the Clinical Practice Research Datalink (CPRD) to access anonymised general practice records on all registered patients, including diagnoses, tests, prescribed treatments and referrals. We will obtain data on each patientâs interaction with a health professional and the staff role field will be used to identify GP types (partner, salaried, or locum) involved in any recorded interaction. This will be our key parameter of interest and we will evaluate its association with patient outcomes. A cross sectional analysis will be conducted for each financial year for the period 2015-2021 to explore the associations between staff role and patient outcomes at the patient level. Moreover, our cohort study is eligible for linkage to Hospital Episodes Statistics (HES) data and this will allow us to obtain detailed information on any form of hospital attendance for all patients in the practices that participate in the linkage scheme.
We will focus on working patterns, service utilisation and patient outcomes. Our primary patient outcome will be patients revisiting general practice within 7 days or 15 days. Secondary outcomes will include: secondary care referrals, unplanned hospital admissions within 7 days or 15 days (HES linkage), A&E attendance within 7 days or 15 days (HES linkage), ambulatory care sensitive conditions (ACSC) hospitalisations within 7 days or 15 days (HES linkage), antibiotic, strong opioids and hypnotics prescriptions and validated prescribing safety indicators.
We will use multi-level mixed effects logistic regression models to quantify the association between exposure (staff role) and outcomes, controlling for all available covariates. Outcomes and key covariates will be appropriately described over time, at the patient, GP and general practice level.
Source - and 41 more projects — click to show
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Healthcare utilisation, symptoms, prescriptions and new disease in people with COVID-19 managed in the community or hospital. — Jennifer Quint ...
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Healthcare utilisation, symptoms, prescriptions and new disease in people with COVID-19 managed in the community or hospital.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-16
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Ardita Koteci - Collaborator - Imperial College London
Chukwuma Iwundu - Collaborator - Imperial College London
Claudia Gulea - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Hannah Whittaker - Collaborator - Imperial College London
Mark Weeks - Collaborator - Imperial College London
Rikisha Shah Gupta - Collaborator - Imperial College LondonOutcomes:
Our study period will only include people who test positive from August onwards, so essentially wave 2 and the time of wider testing to try to mitigate the fact people diagnosed in wave 1 are so different from those identified in wave 2. We will acknowledge the issue of occupational screening in the limitations. We will also look at people who test positive for covid post vaccine as we appreciate this may alter outcomes.
Outcomes to be measured
1.Incidence of new symptoms following COVID-19: including respiratory (upper and lower), cardiovascular, gastrointestinal, musculoskeletal, dermatological, neurological, psychological and general
2.Incidence of new non-communicable diseases: including cardiovascular, respiratory, gastrointestinal, endocrine, renal, psychological/psychiatric conditions
3.Incidence of new medication prescriptions including inhalers, analgesics, diuretics
4.Healthcare utilisation, including referral to hospital
5. Difference in risk or rate of outcomes and healthcare use across patients post-COVID-19 diagnosis versus 12 months prior to COVID-19
6. Monthly rates of outcomes post-COVID-19 diagnosis
7. Difference in rates of outcomes and healthcare use across individuals who tested positive for COVID-19 and who subsequently received a vaccine for COVID-19, post versus pre vaccination timeframe.Description: Technical Summary
Little is known about ongoing symptoms, healthcare utilisation and incidence of new disease among people with confirmed or possible COVID-19, and how this differs relative to severity of COVID-19 illness (i.e. those who are hospitalised). This will be a retrospective cohort study using routinely collected primary care records from CPRD Aurum in the first instance, followed by use of linked data from HES and ONS when more recent data are available. The study cohort will include adults who tested positive for COVID-19 or were diagnosed with possible COVID-19 between August - October 2020, with subsequent follow up until the end of data collection. We will describe outcomes between patients who were hospitalized with COVID-19 and patients who tested positive for COVID-19 but did not require hospitalization and if numbers allow, in those with possible COVID-19. We will estimate incidence of predefined symptoms, diseases, prescriptions and healthcare utilisation (including referral to hospital). We will use negative binomial regression to compare incidence rates based on aggregate level data taking into account the magnitude of both the numerator and denominator of interest. We plan to repeat analyses with a longer follow up period and with linked hospital and mortality data as they become available.
The study cohort will include adults who tested positive for COVID-19 or were diagnosed with possible COVID-19 between August - February 2021.
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A Case Control and Cohort Design Study, using Multi-state Models, Analysis of Treatment Patterns in Chronic Obstructive Pulmonary Disease and Asthma. — Abi Mawer ...
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A Case Control and Cohort Design Study, using Multi-state Models, Analysis of Treatment Patterns in Chronic Obstructive Pulmonary Disease and Asthma.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-18
Organisations:
Abi Mawer - Chief Investigator - Twist Health
Abi Mawer - Corresponding Applicant - Twist Health
Amy Mulick - Collaborator - Twist Health
James Jordan - Collaborator - NHS Scotland
Lina Eliasson - Collaborator - Twist Health
Magdalena Murawska - Collaborator - Twist Health
Rebecca Sarson - Collaborator - Twist Health
Stephanie Best - Collaborator - Twist HealthOutcomes:
Outcomes to be measured will include.
⢠From HES APC: Hospitalisation spells due to indication (Asthma or COPD); Bed days due to indication
⢠From HES A&E: Admissions to secondary care via A&E; All cause visits to A&E
⢠From CPRD AURUM: Prescriptions of OCS; exacerbations as recorded in primary careControlled and uncontrolled status will be algorithmically defined.
A âspellâ is a period of hospitalisation.Discharge codes are organised with the primary code being the main reason for admission. This may not be what the patient first presents with when arriving at hospital.
Description: Technical Summary
This project uses linked primary and secondary care data from England to model the probability of transition from one treatment to the next given the current treatment and time of the transition. Due to the lack of pilot data, we do not put any hypothesis about the estimated transition, occupation probabilities or of the dependence of these probabilities on any baseline features.Therefore, we do not plan to adjust for baseline variables. The purpose of this study is to estimate probabilities.
Our secondary objective will compare the evolution of these transitionsâ probabilities between controlled and uncontrolled groups.
We will employ both a cohort and case-control study designs. We will use multistate statistical models to model the probability of the next treatment given the current prescribed treatment and the time of treatment transition. The possible dependence on the history will be handled via multinomial modelling.
Using the same multi-state methodology, we are going to analyse the transition probabilities between the controlled and uncontrolled groups and compare the evolution of these probabilities over time.
We will use the most recent AURUM data available as the end of study date.
We will include patients who have a diagnosis of COPD/Asthma in primary care on or after 1st November 2018, who are >18 years old and have >12 months follow-up data. We will use data available 12 months prior to index to describe the patient demographics. The date of first diagnosis will be defined as âindex dateâ.We will define the treatment pathway at a class level from treatment records in primary care.
Controlled and uncontrolled patients will be defined using exacerbations and hospitalisations relating to Asthma or COPD. Hospitalisations will include admissions to Accident and Emergency (A&E) using HES A&E data. âHospitalisationsâ will be defined using HES Admitted Patient Care (APC) data.
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The impact of systemic corticosteroids on diabetes mellitus and osteoporosis in adults: a retrospective cohort study — Samuel Adamsson Eryd ...
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The impact of systemic corticosteroids on diabetes mellitus and osteoporosis in adults: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Samuel Adamsson Eryd - Chief Investigator - AstraZeneca AB (Sweden)
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Hungta Chen - Collaborator - Astra Zeneca Inc - USA
Karolina Andersson Sundell - Collaborator - Astra Zeneca R&D Molndal Sweden
Philip Ambery - Collaborator - Astra Zeneca Ltd - UK Headquarters
Phillip Hunt - Collaborator - Astra Zeneca Inc - USA
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Incident diabetes mellitus (DM); DM therapy intensification; incident osteoporosis (including fragility fracture); change in glycosylated haemoglobin; change in random blood glucose; body mass index (BMI) change; blood pressure change; lipid profile change;
Description: Technical Summary
Systemic corticosteroids (CS) are important for managing inflammation, but have profound endocrine effects on glucose metabolism and bone turnover. Few consistent data exist describing the association of CS and risks of developing either diabetes mellitus (DM) or osteoporosis, and progression of DM.
The study will determine if oral or intravenous CS (OIVCS) exposure in adults is a risk factor for: 1) developing DM (co-primary objective); 2) intensification of DM treatment (co-primary); 3) developing osteoporosis (secondary); and 4) changes in vascular disease risk factors in Type 2 DM (exploratory); testing the hypothesis that disturbance in glucose metabolism is driven by OIVCS in a dose-dependent manner with both acute and chronic cumulative effects.
A matched cohort design comparing OIVCS-exposed versus non-exposed patients is proposed drawn from CPRD GOLD (upto December 2019) with linked hospital data. The studies of incident diabetes and osteoporosis follow-up patients from first-ever OIVCS prescription whereas for intensification of DM treatment, from first OIVCS prescription after DM diagnosis. OIVCS-exposed patients will be matched to non-OIVCS patients similar in baseline characteristics from the same GP practice.
OIVCS exposure will be measured by intended time exposed for âonâ episodes, dose intensity, and cumulative exposure. Concomitant prescribed CS either inhaled, topically applied, or otherwise administered will also be assessed.
The primary analyses will be time-to-event, namely first diagnosis of DM, first intensification of DM glycaemia management, or first diagnosis of either osteoporosis or fragility fracture, respectively using Cox regression modelling with mixed effects, the principal output will be the hazard ratios (and their 95% confidence intervals) for the exposures and covariates on the outcomes of interest.
The study will provide population-wide estimates of the excess metabolic risks associated with CS prescribing adding to the current body of knowledge which hitherto has comprised smaller studies of specific clinical subgroups with limited generalisability.
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Respiratory Syncytial Virus (RSV) infections in England: estimating the burden of antibiotic prescriptions, healthcare utilisation and associated costs. — Ceire Costelloe ...
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Respiratory Syncytial Virus (RSV) infections in England: estimating the burden of antibiotic prescriptions, healthcare utilisation and associated costs.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-09
Organisations:
Ceire Costelloe - Chief Investigator - Imperial College London
Lucy Miller - Corresponding Applicant - Imperial College London
Julie Robotham - Collaborator - Public Health England
Koen Pouwels - Collaborator - University of Oxford
Thomas Beaney - Collaborator - Imperial College LondonOutcomes:
Study 1: (Primary outcomes) Primary care antibiotic prescriptions attributable to RSV described by antibiotic class; Respiratory primary care antibiotic prescriptions attributable to RSV; (Secondary outcomes) All acute primary care antibiotic prescriptions attributable to RSV; Specific respiratory primary care antibiotic prescriptions, with potential importance for resistance, attributable to RSV. Study 2: (Primary outcomes) Respiratory general practice consultations and associated costs attributable to RSV; All-cause A&E attendances and associated costs attributable to RSV; Respiratory hospital admissions and associated costs attributable to RSV; All-cause outpatient appointments and associated costs attributable to RSV; (Secondary outcomes) All-cause general practice consultations and associated costs attributable to RSV; Cardiorespiratory general practice consultations and associated costs attributable to RSV; Respiratory A&E attendances and associated costs attributable to RSV; Cardiorespiratory hospital admissions and associated costs attributable to RSV. Study 3: (Primary outcomes) Respiratory primary care antibiotic prescriptions attributable to RSV; Respiratory general practice consultations and associated costs attributable to RSV; All-cause A&E attendances and associated costs attributable to RSV; Respiratory hospital admissions and associated costs attributable to RSV; All-cause outpatient appointments and associated costs attributable to RSV.
Description: Technical Summary
Background: Respiratory Syncytial Virus (RSV) is associated with high healthcare utilisation and antibiotic prescribing within England. Therefore, RSV vaccines could act as an intervention to reduce RSV burden and support antibiotic use optimisation. Reduction of antibiotic use in primary care is a cornerstone of antimicrobial stewardship interventions aiming to curb the rise in AMR. Quantification of the impact of RSV vaccines on AMR does not exist. More research is required to inform cost-effectiveness models of RSV vaccines that can include AMR outcomes. RSV primary care antibiotic prescribing by antibiotic type and RSV healthcare utilisation that includes A&E attendances, outpatient appointments and associated costs for all age groups is unknown.
Research questions
1. What antibiotics and how many are attributable to RSV infections in England?
2. What healthcare services and how many contacts are attributable to RSV infections in England?
3. What is the total cost of RSV-associated healthcare utilisation in England?
4. How does RSV primary care antibiotic prescribing, and health utilisation costs vary according to primary care antibiotic prescribing volume of general practices within England?
Methods:
Study 1: Time series analysis of primary care antibiotic prescriptions (CPRD) with corresponding surveillance of key respiratory pathogens (SGSS & RDMS) â no linkage - will estimate the proportion of primary care prescriptions attributable to RSV infections by antibiotic type.
Study 2: Time series analysis of healthcare contacts with corresponding surveillance of key respiratory pathogens (SGSS & RDMS) - no linkage - will estimate the proportion of healthcare contacts and associated total cost attributable to RSV infections.
Study 3: Multilevel models will explore RSV antibiotic prescribing and RSV healthcare utilisation costs by primary care antibiotic prescribing volume.
Healthcare contacts will be based on GP consultations (CPRD), A&E attendances, hospital admissions and outpatient appointments (Hospital Episode Statistics (HES)).
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Retrospective database study to describe healthcare resource utilization in patients on antimuscarinics with overactive bladder in England — Kirsten Leyland ...
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Retrospective database study to describe healthcare resource utilization in patients on antimuscarinics with overactive bladder in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-25
Organisations:
Kirsten Leyland - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Kirsten Leyland - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Collaborator - Astellas Pharma Europe Ltd. - UK
Bas van der Poel - Collaborator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Collaborator - Astellas Pharma Europe Ltd. - UKOutcomes:
Primary Outcome
OAB-related HCRU: Primary care consultations; Secondary care consultations; Secondary care referrals; Primary care diagnostic procedures; Secondary care diagnostic procedures; Secondary care therapeutic procedures; Prescriptions for OAB-relevant medication use
Secondary Outcomes
Demographic and Clinical Characteristics: Patient demographics; Clinical characteristics/history; Index of Multiple Deprivation; Comorbidities; Polypharmacy; Alternate OAB treatments
Treatment Patterns: Order and permutations of cycles of AMs prescribed and of Alternate OAB treatments
Treatment Duration: Time from AM treatment index date to end of each AM cycle and the first AM treatment episode (AM discontinuation death, end of follow-up period).
Referral to Secondary Care: Proportion of patients referred; Time to referral
Cost of OAB-related HCRU: Total costs for each defined health care resource; Total costs for all resources
Description: Technical Summary
Overactive bladder (OAB) syndrome, characterized by the core symptom of urinary urgency, affects more than 500 million people worldwide, with approximately 12% of UK adults affected. Current National Institute for Health and Care Excellence (NICE) and local formulary guidelines recommend first-line treatment with the lowest-cost antimuscarinic (AM) agent and, if that fails, they encourage âcyclingâ through multiple antimuscarinic (AM) treatments, despite limited evidence of clinical effectiveness and the unknown healthcare burden placed on UK OAB patients. This study will describe healthcare resource use (HCRU), economic burden, demographic characteristics and treatment patterns in patients who cycle through AM treatments.
This study is a retrospective longitudinal observational study utilizing linked electronic medical records from UK primary care (GOLD) and English secondary care data (HES APC and HES OP). Patients who have used at least 1 AM treatment (between 1 Jan 2014 and 31 Dec 2017 will be followed-up for a fixed period of 18 months and grouped by the number of different AMs used during their treatment period (1, 2, 3 or more).
We expect a sample size of approximately 10,000 patients (based on a feasibility study of AM patient data from 2015 in CPRD GOLD and the percentage of patients eligible for HES linkage). Descriptive statistics will be used to describe HCRU, costs associated with OAB, and demographic and clinical characteristics. Kaplan-Meier plots will be used for time-to-secondary care referrals and Sunburst plots for OAB treatment patterns. Due to the descriptive nature of this analysis, no statistical comparisons will be made between the cycling groups.
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Characterising the young chronic obstructive pulmonary disease (COPD) patient in the United Kingdom: A descriptive study looking at clinical and aetiological factors utilising Clinical Practice Research Datalink (CPRD) — Ruth Farmer ...
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Characterising the young chronic obstructive pulmonary disease (COPD) patient in the United Kingdom: A descriptive study looking at clinical and aetiological factors utilising Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-12
Organisations:
Ruth Farmer - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Richard Moore - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Richard Moore - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Richard Moore - Collaborator - Boehringer-Ingelheim International GmbHOutcomes:
For the primary descriptive function of this analysis, the following variables will be captured:
o Previous asthma diagnosis
o Alpha-1 antitrypsin prevalence
o Smoking behaviour
o Time to diagnosis from first onset of symptoms
o Prevalence of individual symptoms
ï§ Breathlessness
ï§ Cough
ï§ Chest infection requiring antibiotics and/or corticosteroids
ï§ Presence of sputum
ï§ Anxiety/depression
o Typical healthcare utilisation (primary and secondary care)
ï§ i.e. number of hospital admissions related to respiratory conditionsDescription: Technical Summary
This is a descriptive study looking at the aetiological characteristics and healthcare resource utilisation for patients diagnosed with COPD before the age of 65. Patient will enter the study at their first coded diagnosis of COPD (confirmed by a FEV1/FVC ratio of <0.7) and data will be taken from the 2 year period prior to diagnosis on respiratory presentations to both primary and secondary care. Prevalence of key respiratory symptoms will be recorded and their association with impaired mental health (in terms of anxiety/depression) will be analysed using chi-square tests. Prevalence of pre-existing asthma and alpha-1 antitrypsin deficiency will also be recorded. Population statistics will be reported using mean, SD, median, IQR, categorical variables will be reported as frequencies and percentages. The discussion will aim to identify potential opportunities to improve diagnosis of COPD in younger patients and present hypotheses for further research.
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The nexus of diabetes, hypertension, and depression and its contribution to multimorbidity in United Kingdom — Misghina Weldegiorgis ...
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The nexus of diabetes, hypertension, and depression and its contribution to multimorbidity in United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-30
Organisations:
Misghina Weldegiorgis - Chief Investigator - Imperial College London
Misghina Weldegiorgis - Corresponding Applicant - Imperial College London
Edward Gregg - Collaborator - Imperial College London
Jonathan Pearson-Stuttard - Collaborator - Imperial College London
Marisa Sophiea - Collaborator - Imperial College LondonOutcomes:
⢠Prevalence of the single and dominant combinations (duos, trios) of T2DM, HTN, and depression.
⢠Prevalence of morbidity (18 conditions)
⢠We will construct a metric of cumulative MM burden, defined as cumulative person-time between onset and remission or death to provide an index of cumulative individual and community burden.The conditions will be defined using the code-lists for diseases which are currently available in CALIBER and/or Clinical Codes Repository â The University of Manchester. The phenotyping algorithms in the final list will combine Readcodes, ICD-10, drug and procedure codes to extract patients for analyses from the study population.
Description: Technical Summary
Hypertension (HTN) and depression are common in patients with type 2 diabetes mellitus (T2DM) and are known to be associated with poor outcomes. However, this trios' burden and patterns on the prevalence of multimorbidity (MM) is unknown. This study will assess whether the simultaneous existence of T2DM, HTN, and depression affect the prevalence of MM, and whether these patterns are different by age, gender, and SES, as well as by modifiable risk factors such as smoking status, blood pressure, and BMI.
This observational study will examine individuals from the English Clinical Practice Research Datalink (CPRD), linked to Hospitalisation Episode Statistics (HES). The study population will be classified into four groups â individuals without (1) T2DM, HTN, or depression and individuals diagnosed with (2) any single condition (3) any two conditions (4) all three.
We will extract data on 18 common morbidities, that are clinically significant. For each of the four groups of our study population, we will calculate the crude and age/sex-standardized period prevalence for each morbidity by dividing the number of cases by the total population number at the index date. We will report the number of morbidities in categories of 0 â 5+. We will estimate frequencies and 95% confidence intervals for all of our bivariate combinations of our outcomes, and then rank them in terms of relative risk and absolute risk, with the latter defined as the observed bivariate prevalence minus expected prevalence, with expected defined as the product of the observed prevalence of the individual conditions.
We also plan to develop an index of time spent in combined conditions. Time spent with the morbidity for an individual patient will be calculated by subtracting the censoring date from the date of diagnosis of the particular condition.
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Evaluating the risk of incident cardiovascular disease and cardiovascular drug prescribing patterns in patients with liver disease — Alvina Lai ...
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Evaluating the risk of incident cardiovascular disease and cardiovascular drug prescribing patterns in patients with liver disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-23
Organisations:
Alvina Lai - Chief Investigator - University College London ( UCL )
Alvina Lai - Corresponding Applicant - University College London ( UCL )
Stefanie Mueller - Collaborator - University College London ( UCL )
Wai Chang - Collaborator - University College London ( UCL )Outcomes:
Stable angina; Unstable angina; Coronary disease; Non-fatal myocardial infarction; Stroke not further specified; Heart failure; Peripheral arterial disease; Abdominal aortic aneurysm; Stroke; Arrhythmia/sudden cardiac death; Unheralded coronary death; Atrial fibrillation; Mortality all cause; Cancer related mortality; Liver-related mortality; Cardiovascular mortality
Description: Technical Summary
Cardiovascular diseases (CVDs) contributes to the largest fraction of deaths (~17million globally). There is growing evidence for the association of CVD with type 2 diabetes and obesity and a growing recognition of non-alcoholic fatty liver disease (NAFLD) as a potential risk factor. However, other chronic liver diseases (CLDs) have not received adequate attention and this project aims to understand the extent by which CLDs pose a risk to developing subsequent fatal and non-fatal CVDs. We will investigate risk across demographic groups (age and sex) and across the types of CLD (non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease (ALD), viral hepatitis, fibrosis and cirrhosis). We will employ linked primary care, secondary care and mortality data in England to investigate the incidence rates of CVD in patients with CLD. We will analyse prescribing patterns of CVD medications in these patients. We will perform a large-scale propensity score analysis to match cases (patients undergoing CVD therapy) to controls followed by time-dependent Cox modelling on a mortality (all-cause, cardiovascular, cancer and liver). We will explore adherence to and persistence with CVD drugs in patients with CLD. Our findings may be used to design new screening strategies in CLD patients at risk of CVD conditions and inform treatment strategies in these patients.
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CORYLUS UK: A retrospective observational cohort study of the impact of COVID-19 on systemic lupus erythematosus patients in England using data from linked primary and secondary care databases — Jay Were ...
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CORYLUS UK: A retrospective observational cohort study of the impact of COVID-19 on systemic lupus erythematosus patients in England using data from linked primary and secondary care databases
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-09
Organisations:
Jay Were - Chief Investigator - Health iQ
Shea O'Connell - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Boglarka Kovacs - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQ
Mico Hamlyn - Collaborator - Health iQOutcomes:
The number of patients in each SLE sub-cohort; The total number and cumulative incidence of COVID-19 infections per calendar month amongst these sub-cohorts, stratified by COVID-19 severity; Demographic profiles for each sub-cohort (Mean, median, minimum, and maximum age at SLE diagnosis, gender, ethnicity, BMI, total time in cohort, mean and median follow-up time, Charlson Co-morbidity Score); Clinical profiles of SLE patients at entry into the observation period (Recorded prescriptions in primary care for corticosteroids, other steroids, immunosuppressive agents: azathioprine, cyclosporin, methotrexate, mycophenelate, and hydroxychloroquine or other antimalarial; number and percentage of patients with a record in HES relating to high cost biologics, Number and percentage of patients with comorbidities of interest (diabetes, hypertension, history of pneumonia, arterial/venous thrombosis, haemolytic anaemia, end-stage renal disease or dialysis, nephritis, history of myocardial infarction, history of stroke, obesity, hypercholesterolemia); mean, median, minimum, and maximum age of SLE patients at COVID-19 diagnosis; acute case fatality rate of COVID-19; COVID-specific admission rate and lengths of stay; all-cause admission rates and lengths of stay between COVID-19 severity groups, including those without a COVID-19 diagnosis; COVID-19 clinical outcomes and therapies in secondary care (respiratory distress, oxygen therapy, mechanical ventilation, organ failure, pneumonia
Description: Technical Summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterised by autoantibodies, systemic inflammation and lymphopenia. There is no cure for SLE, and treatment depends on severity, including non-steroidal anti-inflammatories (NSAIDs), corticosteroids, immunosuppressants, and antimalarial agents such as chloroquine or hydroxychloroquine. Whilst corticosteroids are rapidly effective for suppressing flares, long term use has considerable side-effects[1].
The COVID-19 pandemic has had an enormous impact on patient care for those living with chronic diseases, including lower healthcare-seeking behaviour, and shielding for severely immunocompromised patients to lower their risk of exposure to the virus. However, with similar treatment regimens for SLE and COVID-19 considered, it is unknown whether SLE patients are at a greater or lower risk of severe COVID-19 infections.
This descriptive retrospective observational cohort study aims to investigate the impact that the COVID-19 pandemic has had upon SLE patients, stratified according to the severity of their autoimmune disease. The demographic and clinical profiles of SLE patients will be described, stratified by severity of SLE and COVID-19 status. SLE severity will be determined using an algorithm that incorporates comorbid conditions and medications prescribed within the twelve months prior to the study period. Among SLE patients who are diagnosed with COVID-19 within the study period, metrics for mortality, admissions and lengths of stay will be calculated, stratified by severity of COVID-19.
This description of healthcare resource use will provide insight into whether the incidence rates of COVID-19 amongst SLE patients are higher or lower than published incidences amongst the general population, and whether patients with more severe SLE have experienced worse COVID-19 specific outcomes and mortality rates. This information can be used to inform policy and improve patient management for SLE patients who may be exposed to COVID-19.
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Prevalence and healthcare utilization of patients with Eosinophilic granulomatosis with polyangiitis (EGPA) in the Clinical Practice Research Datalink database — Rupert Jakes ...
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Prevalence and healthcare utilization of patients with Eosinophilic granulomatosis with polyangiitis (EGPA) in the Clinical Practice Research Datalink database
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-16
Organisations:
Rupert Jakes - Chief Investigator - GlaxoSmithKline - UK
Jeremiah Hwee - Corresponding Applicant - GSK
George Mu - Collaborator - GSK
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
lorraine harper - Collaborator - University of Birmingham
Qinggong Fu - Collaborator - GSKOutcomes:
Primary outcomes: prevalence; incidence.
Secondary outcomes: EGPA-specific hospitalizations; EGPA-specific hospitalization length of stay; any-cause hospitalizations; any-cause hospitalization length of stay; any procedures undertaken; any imaging tests; any outpatient visits; specialty seen in outpatient visits; any primary care visit with a general practitioner; any primary care visit with a nurse; any primary care visit with an allied health professional; any oral corticosteroid use.Description: Technical Summary
The primary objectives are to estimate the prevalence of EGPA for each calendar year between 2005 and 2019 inclusive and to estimate the annual incidence rate of EGPA between 2006 and 2019 inclusive. The secondary objectives are to describe demographics at time of first recorded EGPA diagnosis (index) and clinical characteristics in the 12 months prior to the index date (baseline), and to describe health care resource use, including the number of hospitalizations, Accident & Emergency (A&E) visits, outpatient visits, procedures undertaken, and imaging tests among EGPA patients during the 12 months following index date. CPRD-AURUM will be used to find patients diagnosed with EGPA (the numerator). The denominator for the prevalence of EGPA will be patients registered within CPRD-AURUM within the respective calendar year. The denominator for EGPA incidence will be patients with at least 365 days after the first registration in the prior to contributing to time at risk.
Linkage of CPRD-AURUM with Hospital Episode Statistics (HES)-Admitted Patient Care will be used to obtain healthcare use for EGPA-, any-cause hospitalizations, length of stay, and any procedures. The HES Accident & Emergency data file will be used to obtain any-cause accident and emergency visits. The HES Outpatient data file will be used to obtain any-cause outpatient visits. The HES Diagnostic Imaging Dataset will be used to obtain imaging tests. Primary care visits will be determined using CPRD-AURUM.
Prevalence and incidence will be reported as a rate per 1,000,000 persons and 1,000,000 person-years, respectively. All healthcare utilization will be reported using distributions, proportions, mean, median, and range.
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The impact of systemic corticosteroids on major adverse cardiovascular events, solid-tumours and mortality in adults: a retrospective cohort study. — ...
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The impact of systemic corticosteroids on major adverse cardiovascular events, solid-tumours and mortality in adults: a retrospective cohort study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-30
Organisations:
- Chief Investigator -
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Major adverse cardiovascular events (MACE); incident solid-tumours; mortality.
Description: Technical Summary
Systemic corticosteroids (CS) are important for managing inflammation, but there are limitations to its use. Few consistent data exist describing the association of CS and risks of major adverse cardiovascular events (MACE), solid-tumours or mortality.
The study will determine if oral or intravenous CS (OIVCS) exposure in adults is a risk factor for: 1) MACE; 2) solid-tumours; and 3) mortality; testing the hypothesis that disturbance in glucose metabolism is driven by OIVCS in a dose-dependent manner with both acute and chronic cumulative effects.
A ânew-userâ matched cohort design comparing OIVCS-exposed versus non-exposed patients is drawn from CPRD GOLD with linked hospital data. Cases have a MACE, incident solid-tumours or mortality. It is a matched cohort study so exposed will compared and matched to non-exposed patients similar in baseline characteristics from the same GP practice.
OIVCS exposure will be measured by intended time exposed for âonâ episodes, and dose intensity. Concomitant prescribed CS either inhaled, topically applied, or otherwise administered will also be assessed as covariates.
The primary analyses will be time-to-event, namely cardiovascular outcomes, solid-tumours and mortality, respectively using Cox regression modelling with mixed effects, the principal output will be the hazard ratios (and their 95% confidence intervals) for the exposures and covariates on the outcomes of interest.
This study will include applying for permission to carry out the study, data cleaning and statistical analysis. The aim will be to publish this research in a peer-reviewed journal. The study will provide population-wide estimates of the excess cardiovascular risks associated with CS prescribing adding to the current body of knowledge which hitherto has comprised smaller studies of specific clinical subgroups with limited generalisability.
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Can we use routinely collected primary care medical records to assess and explain variations in major lower extremity amputation rates across the England? — Laura Gray ...
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Can we use routinely collected primary care medical records to assess and explain variations in major lower extremity amputation rates across the England?
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-17
Organisations:
Laura Gray - Chief Investigator - University of Leicester
- Corresponding Applicant -
Andrew Nickinson - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of Leicester
John Houghton - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Rob Sayers - Collaborator - University of Leicester
Tanya Payne - Collaborator - University of LeicesterOutcomes:
Major lower extremity amputation (MLEA) defined as a lower limb amputation above the ankle. See Appendix 1 for codes).
Description: Technical Summary
This study comprises two work packages which are outlined below.
Work Package One:
This work package aims to assess the agreement in case ascertainment of major lower extremity amputation (MLEA) between primary care (Clinical Practice Research Datalink (CPRD)) and secondary care (Hospital Episode Statistics (HES)) data in order to establish if MLEA are well recorded in primary care (CPRD).Cases of MLEA fitting the inclusion criteria within the study period of 01/01/2009 â 31/12/2019 will be ascertained in two ways: by using OPCS-4 codes in HES and also by using READ(SNOMED) codes in CPRD).
Agreement in MLEA cases between HES and CPRD will be assessed using specificity, sensitivity, positive and negative predictive value and Cohenâs Kappa coefficient. Logistic regression analysis will be performed to investigate reasons for disagreement between databases.
Work Package Two:
The aims of this work package are to establish the incidence proportion of MLEA in England, investigate whether this differs over time and regionally and explain any regional differences.Using data from the created cohort in work package one, the overall and regional incidence proportion of MLEA will be calculated giving both a crude and standardised outcome measure. Time trends in incidence will be investigated using plots Poisson regression models. Regional variation in incidence will be assessed by calculating the coefficient of variation with reasons for any observed differences explored using Poisson regression models.
CPRD population data needed to calculate case agreement, incidence and regional risk factor/demographic proportions and incidence denominators will be gathered using CPRD denominator files and a large random sample of one million patients for risk factor/demographic data.
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Trends in use of Glucose-lowering Medications in Patients with Type 2 Diabetes and Chronic Kidney Disease, 2000-2020 — Julia Liaw ...
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Trends in use of Glucose-lowering Medications in Patients with Type 2 Diabetes and Chronic Kidney Disease, 2000-2020
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Julia Liaw - Chief Investigator - Rutgers, The State University of New Jersey
Julia Liaw - Corresponding Applicant - Rutgers, The State University of New Jersey
Abner Nyandege - Collaborator - Rutgers, The State University of New Jersey
Chintan Dave - Collaborator - Rutgers, The State University of New JerseyOutcomes:
This is a drug utilization study, and thus there are no outcomes of interest.
Description: Technical Summary
Renal disease is a common complication of type 2 diabetes (T2DM) affecting one in three patients. In fact, the global rise in the incidence of end-stage renal disease, dialysis, and renal transplantations can be attributed primarily to the increasing prevalence of T2DM. The co-occurrence of T2DM and chronic kidney disease augurs a long-term clinical course characterized by greater insulin resistance, accelerated progression of T2DM, and an increased risk of developing cardiovascular disease (CVD). Meanwhile, chronic renal insufficiency also decreases the clearance of most antidiabetic agents and their active metabolites â predisposing patients to drug-related toxicities, particularly hypoglycaemia. The recent publication of landmark clinical trials has shown that certain glucose lowering agents â such as sodium/glucose cotransporter-2 inhibitors (SGLT2i) and glucagon like peptide 1 receptor agonists (GLP-1RA) reduce the incidence of adverse renal events. However, it is currently unclear whether these benefits observed in clinical trials have resulted in a quantifiable change in prescribing patterns of glucose lowering agents, especially in patients with CKD. The overall purpose of this proposal is to examine the trends in the use of glucose-lowering medications in patients with T2DM between 2000-2020 and compare these trends in patients with and without CKD. We will examine the historical use of glucose lowering therapies and estimate how the publication of these landmark clinical trials have impacted prescribing patterns. We will achieve this objective by conducting serial cross-sectional studies (by year) describing the trends in the patterns of initiating of glucose lowering agents. We will also identify patient characteristics (e.g. albuminuria, cardiovascular disease) that facilitate the adoption of these newer glucose lowering therapies.
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Influence of allopurinol in addition to colchicine on Major Adverse Cardiac Events (MACE): a retrospective population-based cohort study — Arief Lalmohamed ...
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Influence of allopurinol in addition to colchicine on Major Adverse Cardiac Events (MACE): a retrospective population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-04
Organisations:
Arief Lalmohamed - Chief Investigator - University Medical Centre Utrecht
Jeroen Houwen - Corresponding Applicant - University Medical Centre Utrecht
Toine Egberts - Collaborator - Utrecht UniversityOutcomes:
A composite outcome of MACE is our primary outcome of interest and is defined as: Myocardial infarction; stroke, and all-cause mortality. For myocardial infarction and stroke, READ codes will be used (see Appendix I and II).
Description: Technical Summary
Cardiovascular disease (CVD) takes 17.9 million lives each year, which comprises 31% of all deaths, making it the leading cause of death worldwide. Despite lifestyle changes and medical interventions, patients remain at high risk of cardiovascular events. Therefore novel therapeutic strategies are necessary.
Allopurinol and colchicine, two widely used treatments for gout, have recently been linked to a possible improvement of cardiovascular outcomes. The potential underlying mechanism for colchicine lies in the reduction of vascular inflammation and for allopurinol through the reduction of oxidative stress and blood pressure lowering effects. Indeed, two randomized controlled trials confirmed the cardiovascular benefits of colchicine. For allopurinol, evidence is limited to observational data suggesting a reduction of CVD and mortality, especially in patients with high uric acid.
Despite the confirmed cardiovascular benefits of colchicine, two important knowledge gaps remain. Firstly, the combined cardiovascular value of allopurinol and colchicine together has not been studied before. A multimodal approach of reducing vascular inflammation (colchicine) and diminishing oxidative stress / hypertension (allopurinol) might procure synergism on cardiovascular outcomes. Secondly, in particular for colchicine, the time to benefit and duration of cardioprotection after drug cessation remains to be elucidated.
Therefore, the aims of this study are twofold: (1) to evaluate combined use of allopurinol + colchicine versus colchicine alone and (2) to assess time to cardiovascular benefit and drug cessation patterns in relation to major adverse cardiovascular events (MACE) in adult patients with gout.
In this observational cohort study, hazard ratios for MACE will be calculated among combined colchicine + allopurinol users versus colchicine-monotherapy users. In addition, hazard ratios will be stratified by duration of use/time since cessation in order to calculate time to benefit and temporal effects after drug cessation. Time-dependent cox proportional hazards models will be used, adjusted for potential confounders using propensity score matching.
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Surgical site infection in primary care following surgery for hand trauma in adults — Justin Wormald ...
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Surgical site infection in primary care following surgery for hand trauma in adults
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-02
Organisations:
Justin Wormald - Chief Investigator - Nuffield Dept of Orthopaedics
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Jeremy Rodrigues - Collaborator - University of Oxford
Jonathan Cook - Collaborator - University of Oxford
Matthew Costa - Collaborator - University of OxfordOutcomes:
Incidence of surgical site infection following surgery for hand and wrist trauma
Description: Technical Summary
Hand and wrist trauma is common, accounting for 1-in-5 A&E attendances, with an incidence of over 130,000
injuries/year in the UK. The hand and wrist are important for social, occupational and recreational activities.
Injury to this important functional unit can cause significant short and long-term morbidity. Surgical site infection
(SSI) in hand and wrist trauma surgery affects people in terms of additional interventions and prolonged
recovery but has been poorly researched.Methods:
A population-based cohort study of adult patients in primary care that have had surgery for hand and wrist trauma over the last 22 years.Participants:
All patients registered in the Clinical Practice Research Datalink (CPRD) database with at least 1-year follow-up
available pre-inclusion, who have undergone surgery for hand and wrist trauma.Data sources:
I will use pseudonymised NHS primary care (CPRD Gold) provided by CPRD (www.cprd.com). We are replicating this study in similar primary care databases internationally, and are not requesting HES linkage for comparability.Outcomes: Surgical site infection
Measurements: Counts of hand and wrist trauma surgery, counts of post-operative/surgical site infection, prescription, analysis of specific co-morbidities that may increase risk of SSI
Statistics: SSI incidence rates will be calculated as the proportion of the population registered in any contributing practice in a given calendar year who develop SSI following hand and wrist trauma surgery for the first time in their records in that same year. Stratified rates will be obtained by sex and age groups. Univariate then multivariate logistic regression will be used to examine the association of risk factors of interest on developing SSI (including smoking status, diabetes, obesity, and immunosuppressive medication).
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The development of risk-stratified blood-test monitoring strategies for common inflammatory conditions treated with immune suppressing drugs — Abhishek Abhishek ...
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The development of risk-stratified blood-test monitoring strategies for common inflammatory conditions treated with immune suppressing drugs
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-16
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Georgina Nakafero - Corresponding Applicant - University of Nottingham
Christian Mallen - Collaborator - Keele University
Danielle van der Windt - Collaborator - Keele University
Matthew Grainge - Collaborator - University of Nottingham
Richard Riley - Collaborator - Keele University
Timothy Card - Collaborator - University of NottinghamOutcomes:
Primary outcome: Drug discontinuation due to target organ specific adverse event. This will be defined as drug discontinuation with either (a) abnormal blood test results due to target-organ damage, or (b) target organ damage based on clinical code allocation.
Drug discontinuation due to abnormal monitoring blood test results will be defined as present when there is:
(a) a gap between two prescriptions, or between the last prescription date and earliest of death date, moving to a different practice, 5-year follow-up time, or 31/12/2019 (study end date) of ⥠90 days, and
(b) the last prescription is preceded in up to 15 days by abnormal blood test results (to account for any delay in acting on abnormal results) or followed by an abnormal test result in the next 45 days.Abnormal blood test results will be defined according to the British Society for Rheumatology DMARD monitoring guidelines1, and CKD progression will be defined as per the Kidney Disease Improving Global Outcomes guideline 20122:
⢠White blood cells <3.5x109/L,
⢠Neutrophils <1.6x109/L,
⢠Platelets <140x109/L,
⢠Alanine Transaminase and/or Aspartate Transaminase >100 units/L,
⢠CKD progression defined as creatinine difference > 26 micro mol/L above the first or second preceding blood-test result or chronic kidney disease stage progression.In addition to the above blood-test abnormalities, in people with psoriasis, methotrexate discontinuation will be defined to be due to blood-test abnormalities if (i) serum amino-terminal pro-peptide of type III procollagen (PIIINP) is > 8 mg/L on two previous occasions; (ii) if three previous PIIINP measurements were >4.2 mg/ L in the previous 12-month period; or (iii) if previous PIIINP measurement was > 10 mg/L as per guidelines for the British Association of Dermatologists [3].
Secondary outcome: Drug discontinuation due to any reason.
Defined as present if there is a gap between two prescriptions, or between last prescription date and earliest of death date, moving to a different practice, 5-year follow-up time, or 31/12/2019 (study end date) of ⥠90 days.
Description: Technical Summary
Background: The optimal monitoring strategy for adults with common inflammatory conditions treated with long-term immune-suppressing drugs is not known.
Question: What is the optimum strategy of blood testing after the first six months of primary-care immune-suppressing drug prescription?
Objectives: [1] Develop and validate a prediction model for estimating an individualâs risk of target-organ damage conditional on their values of multiple prognostic factors available at 6 months of primary-care immune-suppressing drug prescription, [2] Identify incidence of drug discontinuation for any reason, and due to abnormal monitoring blood test results in each year of prescription.
Methods: Data from Clinical Practice Research Datalink (CPRD) Gold and Aurum will be used. We will utilise CPRD-HES linked data to validate the sensitivity of outcome definition in primary-care data alone.
People with common inflammatory conditions treated with immune-suppressing drugs, will be followed up electronically from day 180 of the first primary-care prescription of a drug of interest until the earliest of target-organ adverse event, drug discontinuation, death, moving to a different practice, 5-year follow-up time, or 31/12/2019 (study end date).
A penalized flexible parametric survival model will be used to develop a risk prediction score for drug discontinuation due to target organ damage using CPRD Aurum given its larger sample size, accounting for competing risks as necessary, and with internal validation using bootstrapping to quantify and adjust for optimism. The predictive performance of the score will be validated in CPRD Gold. GP practices contributing data to both CPRD Aurum and GOLD will be excluded from the validation cohort. Separate risk scores will be developed and validated for each drug of interest. Risk thresholds will be agreed using decision curve analysis and with patient and clinician involvement. Incidence (per 1,000 person-years) of treatment discontinuation in each 12-month of primary-care prescription will be estimated.
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Investigate the determinants and trends of heart failure and other major cardiovascular events in diabetes patients and their subsequent prognosis within the UK population — Francesco Zaccardi ...
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Investigate the determinants and trends of heart failure and other major cardiovascular events in diabetes patients and their subsequent prognosis within the UK population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Kajal Panchal - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of LeicesterOutcomes:
Using both CPRD and HES, the outcome heart failure, ischaemic heart failure and non-ischaemic heart failure will be compared to the outcome myocardial infarction and ischaemic heart disease (e.g unstable angina, stable angina, myocardial infarction or coronary bypass).
Description: Technical Summary
Patients with diabetes have an increased risk of heart failure (HF). Most HF cases tend to present with prior diagnosis of ischaemic heart disease (IHD), such as myocardial infarction. However, in patients with and without diabetes there have been significant improvements in the treatment of risk factors associated with IHD, resulting in reducing trends in myocardial infarction. As such, a higher proportion of HF cases may have not been driven by IHD in the last years, by which glucose can directly affect HF without IHD. This is relevant since it is unknown whether this phenotype transition has occurred. Moreover, whether there are differences by risk factors or diabetes type remains unclear.
This study will use Clinical Practice Research Datalink (CPRD) data linked with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) to investigate the associations between diabetes (type 1 and type 2 diabetes) and IHD and HF over time using Royston-Parmar survival models. In addition, we will explore if the risk factors age, sex, ethnicity, treatment, socio-economic status, and comorbidities have an impact on the incidence trajectories. We will investigate the hospitalisation and mortality risk in patients with a diagnosis of IHD or HF also using Royston-Parmar survival models. We will stratify HF by ischaemic vs. non-ischaemic HF to further explore whether trends have changed over-time.
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WEiGht changes, caRdio-metabolic risks and mortality in patients with hypErThyroidism; all-cohort natural history and comparison of treatment effects in a CPRD-HES linked study. EGRET study — Barbara Torlinska ...
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WEiGht changes, caRdio-metabolic risks and mortality in patients with hypErThyroidism; all-cohort natural history and comparison of treatment effects in a CPRD-HES linked study. EGRET study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-08
Organisations:
Barbara Torlinska - Chief Investigator - University of Birmingham
Barbara Torlinska - Corresponding Applicant - University of Birmingham
Daniel Lasserson - Collaborator - University of Warwick
G. Neil Thomas - Collaborator - University of Birmingham
Jonathan Hazlehurst - Collaborator - University of Birmingham
Julia Priestley - Collaborator - British Thyroid Foundation
Keith Abrams - Collaborator - University of Leicester
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Kristien Boelaert - Collaborator - University of Birmingham
Philip Saunders - Collaborator - NHS BIRMINGHAM AND SOLIHULL CCG
Samuel Finnikin - Collaborator - University of BirminghamOutcomes:
⢠Body weight changes over time;
⢠Prevalence of obesity;
⢠Incidence rate and time-to-event of:
Composite endpoint of major adverse cardiovascular events (MACE) defined as the occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke as per admission to hospital;
admission to hospital due to congestive heart failure;
admission to hospital due to ischaemic heart disease;
admission to hospital due to stroke and transient ischaemic attack (TIA);
either admission to hospital or diagnosis at GP of diabetes mellitus;
diagnosis of dementia
all-cause mortality as per ONS record.Description: Technical Summary
The study aims to establish the natural history of weight changes in hyperthyroidism in any of the three treatment modalities, investigate the risk of obesity in regard to the treatment and compare these risks to the background population, and establish risks of cardio-metabolic conditions and death in each treatment modality. The data on patients diagnosed with hyperthyroidism between 01/04/1997 and 31/12/2015 will come from Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and ONS Death Registry.
The natural history of weight changes will be modelled longitudinally using a flexible joint modelling approach, accounting for mortality (wp1). BMI and obesity prevalence in the background population will be sourced from Health Survey England and compared with the post-treatment prevalence of obesity in patients with hyperthyroidism, stratified by sex with adjustment for age (wp2). Analyses of the incidence and time-to-event of major adverse cardiovascular events (MACE), other cardio-metabolic outcomes, diagnosis of dementia and mortality in each treatment modality will be compared using inverse weights of propensity score (wp3). Incidence rate ratios of outcomes will be modelled with Poisson regression adjusting for time-varying covariates. Time-to-event will be analysed using Cox proportional hazards model. A competing risks approach will be adopted to estimate comparative incidences to allow for the impact of mortality. Pairwise comparisons will be corrected for multiple testing by applying Bonferroni correction.
Our study will bring new knowledge on the risks of developing obesity following the treatment for hyperthyroidism and risks of developing cardio-metabolic morbidity and mortality. Our study has the unique potential to better inform treatment choice, a priority voiced by patients. The findings will also inform the future design of any interventional studies to prevent excessive weight gain and adverse cardio-metabolic outcomes following treatment for hyperthyroidism.
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The Role of Tuberculosis Disease on Non-Communicable Disease Risk: Comparative Analysis of Large Healthcare Databases — Julia Critchley ...
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The Role of Tuberculosis Disease on Non-Communicable Disease Risk: Comparative Analysis of Large Healthcare Databases
Datasets:GP data, Julia Critchley - Chief Investigator - St George' s, University of London
Julia Critchley - Corresponding Applicant - St George' s, University of London
Derek Cook - Collaborator - St George' s, University of London
Iain Carey - Collaborator - St George' s, University of London
Lawrence Phillips - Collaborator - Emory University Medical School
Mary Rhee - Collaborator - Emory University
Matthew Magee - Collaborator - Emory University
Sara Auld - Collaborator - Emory University
Stephen DeWilde - Collaborator - St George' s, University of London
Tess Harris - Collaborator - St George' s, University of London
Umar Chaudhry - Collaborator - St George' s, University of LondonProcessing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Julia Critchley - Chief Investigator - St George's, University of London
Julia Critchley - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
Lawrence Phillips - Collaborator - Emory University Medical School
Mary Rhee - Collaborator - Emory University
Matthew Magee - Collaborator - Emory University
Sara Auld - Collaborator - Emory University
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of London
Umar Chaudhry - Collaborator - St George's, University of LondonOutcomes:
The primary outcome will be an incident NCD of interest. These will be classified into 3 main groups;
1) Type 2 Diabetes (T2DM)
2) Pulmonary disease (COPD, asthma)
3) Vascular Diseases where atherosclerosis is the predominant aetiology (Ischaemic Stroke [IS], Coronary Artery Disease [CAD], Peripheral Vascular Disease [PVD] and Transient Ischaemic Attack [TIA]).Each NCD incident event will be defined based on a combination of diagnostic codes (i.e. Read Codes) and prescription data, using methods previously developed and applied in CPRD data[2-5]. Incident events that result in hospitalisation or death will also be included (see section on data linkages requested).
Description: Technical Summary
Globally Tuberculosis accounts for more deaths due to infectious disease than any other pathogen; around 1.5 million in 2018. Antimicrobial treatment for TB is highly effective, but may result in long-term consequences for TB survivors considered bacteriologically cured. These include chronic inflammation, insulin resistance, lipid dysregulation, and systemic glucose intolerance [1] which predispose to type 2 diabetes mellitus (DM) and CVD. TB-attributable lung damage may also lead to pulmonary impairment and lifelong respiratory disability. This proposal will improve understanding of the relationship between TB disease and subsequent risks of DM, pulmonary disease and CVD, and identify targets for preventing non-communicable diseases (NCDs) among TB patients. We will also assess COVID-19 hospitalisation and mortality risk for our cohort of post-TB patients.
To address these questions, we will use large routine national datasets to assemble a cohort of over 5,000 patients with a history of TB disease. We will use CPRD primary care datasets, classifying patients using Read codes, utilising general practices in England linked to hospital admissions and mortality data. Specifically, we will determine the extent to which TB disease increases the risk of development of type 2 diabetes mellitus (T2DM), pulmonary disease (asthma, COPD) and specific vascular diseases. We will then assess the extent to which biologic sex, Body Mass Index, HIV, race/ethnicity, and age at time of TB disease modify and mediate the relationships between TB and NCD incidence. Finally, we will explore whether TB clinical characteristics can predict early NCD incidence (first diagnosis of an NCD within 5 years after TB diagnosis) among survivors. We will use Coxâs regression models to examine the incidence of different NCDs, fitting terms for each effect modifier and also describing the patterns of risk within ethnic strata. We will develop a risk score to identify patients at risk of early NCD development.
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Does the association between multiple long-term conditions and mortality risk vary across sociodemographic groups? — Mai Stafford ...
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Does the association between multiple long-term conditions and mortality risk vary across sociodemographic groups?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-02
Organisations:
Mai Stafford - Chief Investigator - The Health Foundation
Yannis Kotrotsios - Corresponding Applicant - The Health Foundation
Anne Alarilla - Collaborator - The Health Foundation
Elizabeth Crellin - Collaborator - The Health Foundation
Hannah Knight - Collaborator - The Health Foundation
Jay Hughes - Collaborator - The Health Foundation
Thomas Wagstaff - Collaborator - The Health Foundation
Yannis Kotrotsios - Collaborator - The Health FoundationOutcomes:
Primary outcome: Survival time (based on deaths from all causes)
Secondary outcome: Survival time (based on avoidable deaths)Description: Technical Summary
Prevalence of multiple long-term conditions is higher and age of onset lower among those who are socioeconomically disadvantaged, or from black, Asian and some other minority ethnic groups. Current evidence is mixed on whether deprivation, ethnicity, sex and their intersection modify prognosis once multiple conditions are established. This study will quantify the association between multiple conditions and mortality risk and test effect modifiers. This information could be used to identify sociodemographic groups with multiple conditions that have higher mortality risk and may benefit from targeted care. The coronavirus pandemic has made this issue even more pressing. People with multiple conditions are high users of health care and some may have been especially impacted by disruptions to health care services during the pandemic.
This observational follow-up study of a random sample of adults will address four questions. First, is number and type of multiple long-term conditions associated with mortality risk? Second, do sociodemographic factors moderate these associations? Third, are associations between sociodemographic factors and mortality explained by onset of new conditions, primary care activity, or continuity of care? Fourth, were these associations apparent during a period of âusual NHS careâ, i.e. do associations remain if we consider only mortality before the start of the coronavirus pandemic?
Survival time based on deaths from all causes is the primary outcome. A secondary outcome is avoidable mortality through linkage to ONS registered deaths (using ONS 2019 list of ICD-10 codes for deaths from causes considered avoidable through timely and effective healthcare and public health interventions). Cox regression models will estimate hazard ratios for each demographic factor, multiple condition status and their interaction. Sequential adjustment for new conditions, number of GP consultations, and continuity of care during follow-up will be made to examine the contribution of these mediators to explaining differences in survival.
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Econometric analysis of the distribution of primary and secondary costs and activity for patients with non-communicable diseases — Toby Watt ...
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Econometric analysis of the distribution of primary and secondary costs and activity for patients with non-communicable diseases
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Toby Watt - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Ann Raymond - Collaborator - The Health Foundation
Anna Head - Collaborator - University of Liverpool
Chris Kypridemos - Collaborator - University of Liverpool
Emma Vestesson - Collaborator - The Health Foundation
Geraldine Clarke - Collaborator - The Health Foundation
Jay Hughes - Collaborator - The Health Foundation
Kate Fleming - Collaborator - University of Liverpool
Laurie Rachet-Jacquet - Collaborator - The Health Foundation
Martin O'Flaherty - Collaborator - University of Liverpool
Miqdad Asaria - Collaborator - The Health Foundation
Stephen Rocks - Collaborator - The Health FoundationOutcomes:
Incidence, prevalence, case fatality, and mortality rates for common non-communicable diseases, stratified by year, age, sex, region, patients' quintile group index of multiple deprivation (QIMD), and if data allow ethnicity. We will focus our efforts on diseases with a high burden on the population according to the Global Burden of Disease project (6), namely; coronary heart disease (CHD), stroke, chronic obstructive pulmonary disease (COPD), diabetes mellitus type 2 (T2DM), dementia, asthma, chronic liver disease, breast cancer, prostate cancer, lung cancer, colorectal cancer, skin melanoma, depression, and hypertension. We will expand this list if resources allow us to include more diseases based on the magnitude of their health and economic burden.
Disease accumulation over time, from a list of 211 conditions, allows us to model the incidence and prevalence of basic (two or more chronic conditions) and complex (three or more chronic conditions affecting three or more different body systems) multimorbidity. We will stratify this by year, age, sex, region, QIMD, and if data allow ethnicity (Note that our team is already working towards this using a more limited CPRD dataset).
Number of attendances at outpatient appointments by treatment speciality per year; Number of attendances in A&E by type and treatment outcome (e.g. treated and sent home/admitted) per year; Number of hospitalisations (elective (long-stay/day case) and non-elective) by HRG code per year; Number of attendances at primary care consultations per year; Number and type of primary care prescriptions per year; Costs of health care activity per year. We will stratify these by year, age, sex, region, QIMD, disease duration (from the list of the disease above and for patients without any disease from this list), the number of comorbidities, whether on last year of life and if data allow ethnicity.
Description: Technical Summary
We will use a cohort of 2 million participants randomly sampled from the Clinical Practice Research Datalink(CPRD) and linked Hospital Episode Statistics(HES), Office for National Statistics (ONS) mortality data, Patient-Level Index of Multiple Deprivation(IMD), National Cancer Registration and Analysis Service(NCRAS) data from 2008/09 to 2020/21 to inform the parameters of a microsimulation model, based on the widely published IMPACTNCD modelling framework.
Our overarching aims are to:
1. create mid-term (15-year) projections for all NHS funding and health care activity, assuming that the observed recent trends will continue in the future; and
2. create projections for all NHS funding and health care activity using different assumptions about disease incidence, case fatality, and healthcare activity trends.
Thus, we will produce a holistic estimation of NCDs' prevalence and NCDs' impact on NHS costs and activity. Moreover, we will better understand how changes in the patterns of NCDs affect the health resources used.
Our objective is to interrogate the data and extract:
1. incidence, prevalence, case fatality, and mortality rates for common non-communicable diseases, stratified by year, age, sex, region, socioeconomics and ethnicity.
2. Primary and secondary (inpatient, outpatient, Accident and Emergency) healthcare activity, stratified by the same factors as #1, and by disease duration, number of comorbidities, and whether on last year of life.
3. Prescription costs stratified by the same factors as #2.
We will use generalised additive models for location scale and shape (GAMLSS) for all statistical modelling and the Personal Social Services Research Unit (PSSRU) costs per appointment minute, CPRD prescribing activity and costs â checked against OpenPrescribing and NHS reference costs for costings.
We will use the GAMLSS models in a discrete-time stochastic dynamic microsimulation that simulates the life course of a close-to-reality English synthetic population and tracks the development and accumulation of NCDs and healthcare utilisation.
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Effectiveness of Indapamide Sustained Released on top of Perindopril on blood pressure change: a methodological study to validate effect of anti-hypertensive drugs in Clinical Research Practice Datalink — CELINE DARRICARRERE ...
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Effectiveness of Indapamide Sustained Released on top of Perindopril on blood pressure change: a methodological study to validate effect of anti-hypertensive drugs in Clinical Research Practice Datalink
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-30
Organisations:
CELINE DARRICARRERE - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
CELINE DARRICARRERE - Corresponding Applicant - IRIS - Institut de Recherches Internationales Servier
dominique Procureur - Collaborator - IRIS - Institut de Recherches Internationales Servier
Emmanuelle Jacquot - Collaborator - IRIS - Institut de Recherches Internationales Servier
Jaume Aguado - Collaborator - RTI Health Solutions
MANEL PLADEVALL - Collaborator - RTI Health Solutions
Marie MANGIN - Collaborator - IRIS - Institut de Recherches Internationales Servier
Morgane Ballon - Collaborator - IRIS - Institut de Recherches Internationales Servier
Stéphanie HENNEL - Collaborator - IRIS - Institut de Recherches Internationales Servier
Virginie SIMON - Collaborator - IRIS - Institut de Recherches Internationales Servier
Xabier Garcia de Albeniz - Collaborator - RTI Health SolutionsOutcomes:
Blood pressure Change, Blood pressure control.
Description: Technical Summary
Hypertension is a chronic condition characterized by high blood pressure (BP) that affects 30% of men and 26% of women in England. It is a major contributing factor to cardiovascular outcome and reduction of elevated BP can decrease cardiovascular mortality. Perindopril (tert-butylamine 4mg or arginine 5mg) and indapamide Sustained Released (SR) 1.5mg are common hypertensive treatments.
Antihypertensive treatments efficacy is demonstrated in Randomized Controlled Trials (RCT) based on frequent, iterative BP measures while these measurements are sparse in real life setting. The aim of this study is to assess whether this efficacy can be objectivised using BP records collected in routine practice.
In a main approach, this study will emulate, using Clinical Research Practice Datalink, a planned phase III RCT comparing the BP changes when adding indapamide SR on top of perindopril 4/5mg versus staying on perindopril 4/5mg alone, in patients who have uncontrolled hypertension.
Adults patients with 145 ⤠Systolic BP < 160 mmHg, treated with perindopril 4/5mg at stable dose for at least 4 weeks and who either initiate indapamide SR on top of perindopril or renew their prescription for perindopril 5mg/4mg (without adding other therapies) between 2000 and 2020, will be followed for 1 year. Patients in both groups will be matched using a propensity score. The primary outcome that will be SBP change between baseline and week 8, will be assessed using a linear regression model. Missing data will be handled using multiple imputation and return-to-baseline approaches according to missing pattern.
The secondary objective will further assess how BP effect of antihypertensive drugs can be measured considering real life context (less selected population, sparse BP measures). Thus, different methods like alternative definitions of population, alternative definitions of outcomes (e.g., BP control), and complementary statistical approaches (Standardized Mortality Ratio and Inverse probability censoring weighting) will be used.
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Incidence and prevalence of Antiphospholipid Syndrome in United Kingdom. — Meheni khellaf ...
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Incidence and prevalence of Antiphospholipid Syndrome in United Kingdom.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-29
Organisations:
Meheni khellaf - Chief Investigator - UCB Biopharma SRL - Belgium Headquarters
Meheni khellaf - Corresponding Applicant - UCB Biopharma SRL - Belgium Headquarters
- Collaborator -Outcomes:
Incidence and prevalence of antiphospholipid syndrome.
Description: Technical Summary
The incidence and prevalence of antiphospholipid antibody syndrome (APS) is largely unknown. Duarte-Garcia (2019) has estimated for the population of Olmsted County, Minnesota, with the age- and sex-adjustment to the 2010 US white population: the overall annual incidence rate of adults aged ⥠18 years was 2.1 (95% CI: 1.4-2.8) per 100,000, and the prevalence was 50 per (95% CI: 42-58) 100,000. Gomez-Puerta (2014) estimated the incidence as 5 cases per 100,000 person-years and prevalence of 40-50 cases per 100,000 persons. Given this lack of data we intend to estimate these rates in the population of UK by using the CPRD database over the period study 2010-2019. The target study population included persons in UK who are registered with a primary care practice included in the CPRD primary care databases (GOLD or Aurum)For practices permitting linkage to the HES datasets, sensitivity analysis will be undertaken to assess the robustness of incidence and prevalence estimates based on primary care records versus hospital; records.
We will estimate for each year age- and sex-specific and age- and sex-standardized incidence rates and prevalence.
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Outcomes of maternal epilepsy and antiepileptic medications during pregnancy (PREPArE) — Dheeraj Rai ...
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Outcomes of maternal epilepsy and antiepileptic medications during pregnancy (PREPArE)
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-22
Organisations:
Dheeraj Rai - Chief Investigator - University of Bristol
Paul Madley-Dowd - Corresponding Applicant - University of Bristol
- Collaborator -
Caichen Zhong - Collaborator - Drexel University
Florence Martin - Collaborator - University of Bristol
Harriet Forbes - Collaborator - University of Bristol
Jessica Rast - Collaborator - Drexel University
Kristen Lyall - Collaborator - Drexel University
Kritika Jain - Collaborator - University of Bristol
Neil Davies - Collaborator - University of BristolOutcomes:
Maternal outcomes
1. Hospital admission for epilepsy/status epilepticus/psychiatric morbidities;
2. Outpatient care for epilepsy/status epilepticus/psychiatric morbidities;
3. Accident and Emergency department visits;
4. Self-harm and suicide attempts;
5. Prolonged hospitalisation during pregnancy or following delivery;
6. All cause and cause specific mortality;Pregnancy outcomes:
7. Obstetric complications (including pre-eclampsia/eclampsia);
8. Pregnancy loss (miscarriage, termination of pregnancy, stillbirth);
9. Mode of delivery (including vaginal birth/C-section delivery);
10. Gestational age at birth (Preterm birth);Outcomes in children:
11. Birth defects;
12. Diagnosis of autism spectrum disorder;
13. Diagnosis of attention deficit hyperactivity disorder;
14. Diagnosis of intellectual disability;
15. Diagnosis of epilepsy.Description: Technical Summary
Antiepileptic and mood stabiliser medications (collectively abbreviated as AEDs) refer to an overlapping group of drugs prescribed for a range of neuropsychiatric conditions including epilepsy and bipolar disorder. Their use in pregnancy is often necessary to reduce harms to the mother. There is little robust evidence for the maternal and fetal safety profile of many AEDs although some drugs such as sodium valproate are known to be teratogenic.
Aims: Using data from UK CPRD and Swedish registry data, we will i) describe trends across time in the usage of AEDs during pregnancy; ii) quantify the risk of maternal, pregnancy and child developmental outcomes related to prescribing of AEDs during pregnancy (complete list below), iii) quantify the risk of maternal, pregnancy and child developmental outcomes of epilepsy and other indications for which AEDs are prescribed, and iv) triangulate evidence from multiple methods to strengthen causal inference.
Design: Observational intergenerational cohort study.
Setting: Clinical Practice Research Datalink (CPRD) primary care records linked to Hospital Episodes Statistics (HES), Office of National Statistics (ONS) death records, pregnancy register and social deprivation data in the UK; Records from Swedish national and local registers.
Target population: Representative population-based sample in the UK and Sweden.
Inclusion Criteria: Women in the CPRD pregnancy register, who were registered with the same practice for at least 1 year before pregnancy and throughout the pregnancy period, with data linkage to their child .
Health technologies being assessed: AEDs during pregnancy vs no drug treatment during pregnancy; and continuing vs stopping use of AEDs during pregnancy. Exposures of interest also include indications for AED prescribing.
Outcomes: Maternal: Pregnancy outcomes and delivery outcomes in the mother. Child: diagnosis of autism, ADHD and intellectual disability(ID).
Statistical analyses: Our analysis will involve multivariable regression methods, appropriate for each outcome, while accounting for time at risk.
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Epidemiology and treatment of Myasthenia Gravis (MG): A retrospective study in Clinical Practice Research Datalink (CPRD) and Hospital Episodes Statistics (HES) — Kerina Bonar ...
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Epidemiology and treatment of Myasthenia Gravis (MG): A retrospective study in Clinical Practice Research Datalink (CPRD) and Hospital Episodes Statistics (HES)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
Kerina Bonar - Chief Investigator - UCB Pharma Ltd
Kerina Bonar - Corresponding Applicant - UCB Pharma Ltd
Nada Boudiaf - Collaborator - UCB BioSciences, Inc.Outcomes:
The following outcomes will be measured in the study:
1. Age, sex, weight and body mass index (BMI) at baseline.
2. Incidence and Prevalence
3. MG-related and All-cause mortality
4. Co-morbidities: autoimmune thyroiditis, rheumatoid arthritis, systemic lupus erythematosus, type 1 diabetes, ankylosis spondylitis, psoriasis, psoriatic arthritis, Crohnâs disease, ulcerative colitis, anxiety, depression, dyslipidaemia, obesity, osteoporosis, type 2 diabetes, hypertension and cardiac arrythmias, infections, systemic infection, infections requiring hospitalizations, Charlson co-morbidity index
5. Myasthenia exacerbation and Myasthenia crisis (MC)
6. Treatment patterns with current standard of care therapies (defined in details under Subtitle 17 in the protocol): Acetylcholinesterase inhibitors, steroids, non-steroid immunosuppresants and biologics
7. Health care resource use: Visits to GPs and other healthcare professionals in primary care, GP phone calls, visits to neurologist, visits to any other specialist, outpatient visits (all cause and MG related), day-patient hospitalization (all cause and MG related), ER visits (all-cause and MG-related), admission to hospitals with overnight stay (all cause and MG-related) and length of stay, admission to intensive care unit (all cause and MG-related) and length of stay
8. Ig / PLEX treatment episode overall and during treatment segments
9. Use of corticosteroids overall and during treatment segments: period / episode of steroid use, high dose steroids use, average dose among patients, up-titration, down-titration and discontinuation, episodes of short and long-term useDescription: Technical Summary
To understand the health care burden due to MG in children and adults, this retrospective cohort study aims to assess epidemiology, treatment patterns for the disease, as well as healthcare resource use (HCRU) in an outpatient and inpatient setting in the UK from 2010 to 2019. Study population will include children and adults with at least one diagnosis of MG in either the CPRD or HES during study period. Epidemiology of MG will be assessed in terms of incidence and prevalence in selected years, and treatment patterns during follow-up will be described among incident patients. Clinical burden of disease in incident patients will be expressed as incidence and event rates of MG clinical events (exacerbations, Myasthenic crisis, specific treatments). Linkage to ONS database will be used to assess time and cause of death. Co-morbidities and health economic burden of the disease in terms of healthcare resource utilization in the inpatient and outpatient settings will be reported as incidence and event rates in MG and randomly sampled matched non-MG cohort, and for this objective groups will be compared using conditional logistic regression model to obtain estimate after adjustment for baseline characteristics.
The study will report results separately for adults (â¥18 years of age) and children (when feasible).
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The impact of area level deprivation and geographical variation on survival and resource use in patients with colorectal, gastro-oesophageal, lung or ovarian cancer in England. — anne spencer ...
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The impact of area level deprivation and geographical variation on survival and resource use in patients with colorectal, gastro-oesophageal, lung or ovarian cancer in England.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-18
Organisations:
anne spencer - Chief Investigator - University of Exeter
Thomas Ward - Corresponding Applicant - University of Exeter
Abigail Lloyd - Collaborator - University of Exeter
Antonieta Medina-Lara - Collaborator - University of Exeter
Ruben Mujica Mota - Collaborator - University of Leeds
William Hamilton - Collaborator - University of ExeterOutcomes:
The primary outcomes are survival (i.e. all-cause mortality) and healthcare resource use.
Healthcare resource use will be measured based on quantifying the following components:
⢠Healthcare visits (GP; hospital inpatient and outpatient; A & E)
⢠Healthcare specialist time
⢠Testing procedures
⢠Prescriptions
⢠Treatment, including anti-cancer therapyDescription: Technical Summary
The study aims are:
1. To quantify: a) the expected survival and b) the total healthcare resource use, of colorectal, gastro-oesophageal, lung and ovarian cancer patients stratified by SES and geographical location
2. To characterise the clinical characteristics and the diagnostic and treatment pathways of colorectal, gastro-oesophageal, lung and ovarian cancer patients stratified by SES and geographical locationColorectal, gastro-oesophageal, lung and ovarian cancer patients will be stratified by SES, using the CPRD IMD and geographical location. Survival and healthcare resource use will be summarised across stratified populations, controlling for comorbidities and confounders.
Survival will be quantified using Kaplan-Meier data and estimates of survival likelihood at specific time points. Log-rank tests will be used to test for differences in survival across groups. A ânon-cancerâ control group will be used to assess relative differences in survival. Resource use will be quantified in terms of healthcare visits, healthcare specialist time, testing procedures, prescriptions, and treatments. The likelihood of incurring resource use and the total costs of resource use will be assessed. Costs will be estimated using NHS reference costs, the BNF and the Healthcare Resource Group (HRG) 2017/18 reference costs grouper.
Subsequently, the clinical characteristic profiles of the stratified groups will be quantified, and the diagnostic and treatment pathways of patients assessed, with any differences across stratification groups discussed further. Such analyses will aim to provide insight into potential reasons for any survival and resource use heterogeneity.
CPRD patient-level IMD will be used to stratify patients. ONS data will be utilised to inform patient survival. HES and NCRAS data will provide information on patient diagnostic and treatment pathways, patient resource use and patient comorbidities; NCRAS data will also be used to provide some demographic and clinical information. HES data will also be used to inform patient resource use and patient comorbidities.
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The effect of metformin on health outcomes in routine care: a regression discontinuity analysis. — Till Bärnighausen ...
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The effect of metformin on health outcomes in routine care: a regression discontinuity analysis.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-16
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Hrvoje Curis - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Surrey
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
Primary outcomes (all to be measured over time horizons of one year, five years, ten years, and 15 years): incidence and mortality from the 25 leading non-communicable level 3 causes of death in SDI group A countries, measured by total years of life lost (13). Using primary care data as the source to detect different causes of death may introduce limitations due to less accurate data in primary care data compared to linked secondary care datasets which are more accurate and granular.
Secondary outcomes (all to be measured over time horizons of one year, five years, ten years, and 15 years): probability of at least one all-cause emergency hospitalization; number of all-cause hospitalizations; probability of at least one all-cause hospitalization; probability of at least one severe adverse health event.
Description: Technical Summary
Previous studies investigating the health effects of T2DM therapy administered to T2DM patients and corresponding treatment initiation with metformin are largely limited to controlled clinical trials. While these studies have shown the efficacy of T2DM therapy intensification in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Non-experimental studies, in contrast, may fail to establish causality due to insufficient control of confounding factors. This study seeks to measure the effect of treatment intensification in T2DM patients on short-, mid-, and long-term clinical outcomes (all-cause mortality, HbA1c levels and other T2DM related outcomes) in a routine care set-up. To establish causality, we make use of a regression discontinuity (RD) design taking advantage of major UK clinical guidelines (NICE) recommending T2DM treatment initiation with metformin based on threshold rules related mainly to patientsâ HbA1c level. Because physicians base their treatment decisions on additional considerations besides clinical guidelines, we use an instrumental variable approach that is robust to partial compliance. We evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with HbA1c levels increasingly close to the treatment threshold level. The findings of this study are expected to provide novel insights into the effectiveness of T2DM treatment initiation with metformin in a real-life setting and can directly inform clinical practice.
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Burden of Disease and Treatment Patterns for Patients with Hip and Knee Osteoarthritis in the United Kingdom — Javier Cid ...
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Burden of Disease and Treatment Patterns for Patients with Hip and Knee Osteoarthritis in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-18
Organisations:
Javier Cid - Chief Investigator - Evidera, Inc
Alison Booth - Corresponding Applicant - Evidera, Inc
Mickael Hiligsmann - Collaborator - Maastricht University
Mireia Raluy Callado - Collaborator - Evidera, Inc
Noami Berfeld - Collaborator - Evidera, Inc
Philip Conaghan - Collaborator - University of Leeds
Ravi Iyer - Collaborator - Teva Pharmaceuticals Ltd
Robert Donaldson - Collaborator - Evidera, Inc
Sangtaeck Lim - Collaborator - Teva Pharmaceuticals Ltd
Tahir Saleem - Collaborator - Teva Pharmaceuticals LtdOutcomes:
Baseline characteristics: demographics (i.e age at index, sex, ethnicity, IMD); clinical characteristics (i.e comorbidities)
Medication Use and treatment patterns: the study will consider the following pharmacological treatments as described in the NICE British National Formulary (BNF): Treatment summary for osteoarthritis and soft tissue disorders (Reference 1): (Analgesics, NSAIDs, Cox 2 Inhibitors, Weak Opioids, Strong Opioids, Corticosteroids, Viscosupplements and Tricyclic antidepressants).
Resource utilisation: inpatient visits; outpatient visits; primary care visits (GP and nurse visit); length of hospital stays. These will be presented as all-cause and OA-related.
Direct costs: This will be an exploratory outcome. Direct costs for GP, nurse and specialists visits, hospitalisations will be explored. These will be presented as all-cause and OA-related. Only OA-related surgery will be presented.Description: Technical Summary
Osteoarthritis (OA) is a degenerative joint disease affecting the cartilage and surrounding tissues. In the United Kingdom (UK), approximately 10% of adults have symptomatic and clinically diagnosed OA, with knee OA being the most common. There are no current treatments available to stop or slow OA progression, hence pharmacological management of OA patients focuses on symptom management (i.e. analgesics for pain), with minimal impact on the underlying disease. Published data on estimated direct and indirect costs of OA in the UK are limited, suggesting that more research into this area is imperative to understand burden of OA in the UK
This descriptive study will identify patients with hip/knee OA among adults (⥠18 years) and estimate the annual incidence of hip/knee OA in the general population of England, from 2015 to 2019. The point prevalence (1 January 2019) will also be estimated. Prevalent patients will be defined as those with a diagnosis of hip/knee OA in their medical record anytime until 31 December 2019 (inclusive). Among prevalent patients, resource use in the primary and secondary care setting will be described using summary statistics, counts and proportions, as appropriate. In addition, associated costs will also be estimated. Treatment patterns will also be examined among prevalent patients, focusing on the drug classes patients receive. The analyses will be repeated for patients identified as having moderate-to-severe OA based on receipt of pharmacotherapy. Findings of this study could be valuable in understanding treatment patterns and outcomes among this population.
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The effectiveness of opicapone treatment compared to entacapone in Parkinson's disease using electronic primary healthcare records and linked secondary care data — ...
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The effectiveness of opicapone treatment compared to entacapone in Parkinson's disease using electronic primary healthcare records and linked secondary care data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-24
Organisations:
- Chief Investigator -
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
David Heaton - Collaborator - Harvey Walsh Ltd
Francesca Morgante - Collaborator - St George's, University of London
K Ray Chaudhuri - Collaborator - King's College London (KCL)
Matthew O'Connell - Collaborator - Harvey Walsh Ltd
Myriam Alexander - Collaborator - OPEN Health Group
Rhiannon Thomason - Collaborator - Harvey Walsh Ltd
Stoyan Minchev - Collaborator - Bial Phama UK Ltd
Valentina Di Foggia - Collaborator - Bial Phama UK LtdOutcomes:
Reduction in sleep medication; outpatient contacts (neurology and all); and change in LEDD; increase in sleep medication; number of inpatient stays; number of inpatient bed days (elective and, separately, non-elective by neurology and all); accident and emergency contacts.
Description: Technical Summary
Parkinsonâs disease is associated with disabling motor and non-motor symptoms (including sleep disturbances). Opicapone is a catechol-O-methyltransferase (COMT) inhibitor indicated in Parkinsonâs disease as an adjunct to levodopa and dopa-decarboxylase inhibitors in patients with end-of-dose motor fluctuations. This study aims to evaluate the effectiveness of opicapone in Parkinsonâs disease in routine practice.
The study is a comparative cohort study of new users of opicapone and entacapone as recorded in CPRD Aurum or Gold (CPRD) prescription records. As a secondary objective, first-line opicapone users, i.e. no previous COMT inhibitor, will be compared to opicapone users with a previous entacapone prescription. Outcomes will be markers for effectiveness; number of neurology outpatient contacts (HES outpatient file), a reduction in sleep medication (reduced dose or discontinuation), and a change in daily levodopa equivalent dose (LEDD) (both from CPRD prescribing records). LEDD will be estimated using published methodology. Treatment effectiveness in Parkinsonâs disease may be demonstrated by improved sleep and management of symptoms on a lower LEDD. Symptoms improvement and better tolerability should lead to fewer outpatient contacts.
The opicapone exposed cohort will be propensity score matched to up to four comparators based on greedy nearest neighbour methods including age, sex, disease duration. The mean annual number of neurology outpatient contacts per person and changes in LEDD, will be compared between treatment groups using mixed generalised linear modelling. The proportion with a sleep medication reduction will be compared between treatment groups using conditional logistic regression. Adjustment will be performed for potential confounders not included in the propensity matching. Exposure cohorts will be described in terms of baseline characteristics, healthcare resource use (HCRU), and non-COMT Parkinsonâs disease prescription treatments pre-matching, with the HCRU, and Parkinsonâs disease prescribing compared.
Source -
Influence of safety advisories on drug utilization: interrupted time series and cohort studies — Patrick Souverein ...
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Influence of safety advisories on drug utilization: interrupted time series and cohort studies
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-16
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Aukje Mantel-Teeuwisse - Collaborator - Utrecht Institute for Pharmaceutical Sciences
Marie L De Bruin - Collaborator - Utrecht UniversityOutcomes:
Part I: prevalence of drug use
Part II: Initiation; stopping of citalopram/escitalopram/sertraline/hydroxyzineDescription: Technical Summary
This CPRD study is part of a multi-country study aiming to improve the understanding of the effects of national regulatory medication safety warnings on healthcare delivery and patient safety using data from the UK, Canada, Australia and Denmark. Quantitative analyses for this project include (I) an interrupted time series study to assess the association of drug safety advisories for 24 different drugs in the period 2009-2015 with changes in drug utilization before and after , and (II) a cohort study evaluating the impact of drug safety advisories relating to cardiac arrhythmias for citalopram/escitalopram and hydroxyzine.
We will identify all prescriptions for all relevant study drugs during the study period, 2 years before and 2 years after the advisory. In part I, the number of users each month is counted with the number of patients having at least one day of person-time in a month being the denominator. In part II, a cohort study will be conducted to determine whether patient risk factors, including underlying heart conditions, concomitant medication use, age, and gender, modifify the effect of cardiac arrhythmia advisories on citalopram/escitalopram/hydrozazine initiation and stopping. For each patient having a Read code for an indication for the use of these drugs, starts are defined as having a prescription of a study drug within 7 days of a visit. Stopping will be defined as not having a new prescription issued within 90 days of the end of a prior prescription.Otherwise the patient is classified as a continuer. The end of a prior prescription will be defined as the date of the prior prescription + daysâ supply. Interrupted time series analysis (for I) and generalized linear models to estimate whether patient risk factors modifiy the effect of cardiac arrhythmia advisories on monthly initiation and stopping will be used (for II).
Source -
The Impact of COVID-19 lockdown on the lives of People with Obesity (PwO): A UK primary care based study — Kamlesh Khunti ...
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The Impact of COVID-19 lockdown on the lives of People with Obesity (PwO): A UK primary care based study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-03-23
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Luis Vaz - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - Leicester Diabetes Centre
Tom Yates - Collaborator - University of LeicesterOutcomes:
Changes in BMI after the initiation of the first lockdown period relative to baseline, and whether these changes are modified by being categorised as People with Obesity (PwO), People with Overweight (PwOv) and people with neither obesity nor overweight (Pw/out) at baseline; The frequency of healthcare provider support interactions, among PwO, PwOv and Pw/out after the initiation of the first lockdown period relative to the baseline period; Change in adherence to cardiorenal metabolic disease medications for hypertension, type 2 diabetes and hyperlipidemia, among PwO, PwOv and Pw/out after the initiation of the first lockdown period relative to the baseline period; Incidence, recurrence or exacerbation of anxiety or depression among PwO, PwOv and Pw/out after the initiation of the first lockdown period relative to the baseline period; The determinants of change in weight/BMI after the initiation of the first lockdown period, including include age, sex, ethnicity, deprivation level and baseline BMI/weight.
Description: Technical Summary
Obesity is a significant public health problem across the UK. Defined as an excess of body weight, whether overweight (body mass index (BMI): 25-29) or obese (BMIâ¥30), it is associated with an increased risk of heart disease, diabetes, stroke, cancers, psychological problems such as depression and anxiety, and mortality. The Coronavirus diseaseâ2019 (COVIDâ19), an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARSâCoVâ2 virus), resulted in several stages of lockdown in the UK in order to disease reduce transmission, which may mean that people have seen a change in their BMI, experienced reduced activity, use healthcare resources more sparingly, and may be at increased risk of experiencing mental health issues associated with overweight or obese.
The overall objective of this study is to use Hospital Episode Statistic (HES)-linked Clinical Practice Research Datalink (CPRD) data to investigate the impact of COVID-19 lockdown on People with Obesity (PwO), People with Overweight (PwOv) and people with neither obesity nor overweight (Pw/out). We will investigate change in BMI/weight, use of healthcare resources, such as contact with healthcare professionals, adherence to medications, and incidence, recurrence and exacerbation of anxiety and depression during the COVID-19 lockdown, amongst these populations. Means and standard deviations will be produced to describe changes, and generalised linear models (GLM) for repeated measures will be used to investigate changes in BMI/weight during lockdown (23rd March 2020 - present) relative to baseline (22nd March 2017 â 22nd March 2020 - BMI may be imputed within this period), and investigate effect modification by obesity level. GLM will be used to investigate use of healthcare resources and medication adherence. Incidence of anxiety and depression will be plotted, their correlations with BMI, and trends investigated using survival analysis with a time-varying covariate to indicate periods before and after the initiation of the first lockdown.
Source -
ID-113: Validation and calibration of algorithms predicting the risk of outcomes in heart failure patients — Chelsea and Westminster Hospital NHS Foundation Trust...
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ID-113: Validation and calibration of algorithms predicting the risk of outcomes in heart failure patients
Legal basis:Evaluation of patterns of healthcare
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Chelsea and Westminster Hospital NHS Foundation Trust
Description: Heart Failure.
Source -
ID-112: Investigating integrated health care systems for children and young people (CYP) — Imperial College London...
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ID-112: Investigating integrated health care systems for children and young people (CYP)
Legal basis:Healthcare delivery and Planning
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: North West London.
Source -
ID-109: De-identified Data Access Request: Use of WSIC data for volunteering evaluation. — Imperial College Health Partners...
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ID-109: De-identified Data Access Request: Use of WSIC data for volunteering evaluation.
Legal basis:Healthcare delivery
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: North West London.
Source -
ID-118: Extension Request: Treatment-resistant depression — West London NHS Trust...
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ID-118: Extension Request: Treatment-resistant depression
Legal basis:Restrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Depression in NWL.
Source -
ID-114: De-identified Data Access Request: Psoriasis Study — Imperial College Health Partners...
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ID-114: De-identified Data Access Request: Psoriasis Study
Legal basis:Translational Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Psoriasis.
Source -
ID-120: Adolescents in mental health crisis — Imperial College London...
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ID-120: Adolescents in mental health crisis
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Children and Young People at Chelsea and Westminster.
Source -
ID-110:Extension Request: Repeat Stroke Study — Imperial College Health Partners...
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ID-110:Extension Request: Repeat Stroke Study
Legal basis:Translational Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Atrial fibrillation.
Source -
ID-111: De-identified Data Access Request: FARSITE — Imperial College Health Partners...
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ID-111: De-identified Data Access Request: FARSITE
Legal basis:Translational Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: missing.
Source -
ID-121: WSIC asthma radar high risk reviews — The Hillingdon Hospital NHS Foundation Trust...
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ID-121: WSIC asthma radar high risk reviews
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: The Hillingdon Hospital NHS Foundation Trust
Description: Asthma in NWL.
Source -
ID-119: Depression-related multimorbidity — Imperial College London...
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ID-119: Depression-related multimorbidity
Legal basis:Doctoral research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: Multimorbidity depression.
Source
2021 - 02
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Cost bersonol cyflyrau iechyd yn ystod plentyndod — unknown...
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Cost bersonol cyflyrau iechyd yn ystod plentyndod
Where: unstated
When: 2021-2-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This page is also available in English.
Mae ADR UK yn ariannuâr gwaith o greu fframwaith llywodraethu gwybodaeth ar gyfer cysylltu setiau data iechyd sy'n benodol i glefydau â data ysgolion gweinyddol a phrifysgolion yng Nghymru a Lloegr.
Mae'r astudiaeth yn cynnwys creu llwybr cyfreithiol diogel er mwyn i wybodaeth gyfrinachol am gleifion o setiau data iechyd plant gael ei chysylltu'n ddiogel â ffynonellau data eraill gan barchu preifatrwydd. Unwaith y bydd y broses cysylltu data wedi'i chwblhau, mae'r data'n cael ei wneud yn ddienw cyn ei fod ar gael i ymchwilwyr a gymeradwywyd mewn amgylchedd diogel ar gyfer prosiectau sydd er budd y cyhoedd.
Bydd y fframwaith llywodraethu gwybodaeth yn cael ei phrofi gyda llif data enghreifftiol o setiau data archwilio diabetes cenedlaethol. Mae cysylltu setiau data eraill sy'n benodol i glefydau y tu hwnt i amserlen y prosiect hwn, er ein bod yn gobeithio paratoi'r sylfaen ar gyfer setiau data eraill ar gyflyrau iechyd plant, gan ddechrau gydag Archwiliad Epilepsi 12.
Arweinir y prosiect gan Brifysgol Caerdydd mewn cydweithrediad â Diabetes UK, Coleg Brenhinol Pediatreg ac Iechyd Phlant (RCPCH), Coleg Prifysgol Llundain a Choleg Imperial Llundain, mewn partneriaeth â NHS Digitala'r Adran Addysg (DfE), gan weithio gyda'r Ganolfan Cymorth Rheoleiddioâr Cyngor Ymchwil Feddygol (MRC-RSC) a'r Swyddfa Ystadegau Gwladol (ONS).
Y set ddataMae'r prosiect yn cynnwys sefydlu'r fframwaith llywodraethu gwybodaeth ar gyfer cysylltu sawl set ddata sydd eisoes yn bodoli:
Maeâr Archwiliad Diabetes Paediatreg Cenedlaethol (NPDA) yn cofnodi data o apwyntiadau clinig gydag unedau diabetes pediatreg yng Nghymru a Lloegr, ac mae'n cael ei gadw gan RCPCH. Mae'r Archwiliad Diabetes Cenedlaethol (NDA) yn cofnodi data o apwyntiadau adolygiad oedolion mewn gofal sylfaenol ac eilaidd ar gyfer Cymru a Lloegr, ac mae'n cael ei gadw gan NHS Digital. Rhaid i blant drosglwyddo i wasanaethau oedolion cyn eu bod yn 24 oed; fel arfer, mae plant yn trosglwyddo'n 16 oed. Mae Cronfa Ddata Genedlaethol y Disgyblion (NPD) ar gael ar gyfer Lloegr (yn cael ei gadw gan DfE) a Chymru (yn cael ei gadw gan Lywodraeth Cymru) ac mae'n cofnodi ystod eang o wybodaeth am bobl ifanc sy'n mynd i ysgolion a cholegau yng Nghymru a Lloegr. Mae data addysg bellach yn cael ei storio fel y Cofnod Dysgwr Unigol (ILR) ar gyfer Lloegr a Chofnod Dysgu Gydol Oes Cymru (LLWR) ar gyfer Cymru - mae'r setiau data hyn yn cofnodi set fwy cyfyngedig o wybodaeth am fyfyrwyr sy'n mynd i sefydliadau addysg bellach. Mae set ddata'r Asiantaeth Ystadegau Addysg Uwch (HESA) yn cofnodi ystod eang o wybodaeth am fyfyrwyr sy'n mynd i sefydliadau addysg uwch yn y DU, rydym yn cyfyngu ein detholiad i Gymru a Lloegr.Bydd y gronfa ddata gysylltiedig yn cael ei dileu: mae hyn yn golygu na fydd yn cynnwys unrhyw wybodaeth y gellir ei ddefnyddio i adnabod unigolyn. Er enghraifft, ni fydd yn cynnwys enwau, cyfeiriadau, dyddiadau geni, disgyblion na rhifau GIG.
Bydd y gronfa ddata ymchwil ar gael i ymchwilwyr allanol trwy Wasanaeth Ymchwil Diogel y Swyddfa Ystadegau Gwladol (SYG). Bydd angen cymeradwyo ymchwilwyr a chyflwyno cais llwyddiannus i gael mynediad at y data.
Beth yw potensial y data newydd ei gysylltu hwn?Bydd y gronfa ddata ymchwil yn hwyluso ymchwil i wella llunio polisïau ar gyfer addysg ac iechyd wedi'u teilwra i gyflyrau iechyd penodol. Bydd archwiliadau yn cyflwyno gwybodaeth sy'n benodol iâr clefydau. Bydd hyn yn hwyluso archwiliad dwfn o'r materion sy'n gysylltiedig â phob afiechyd. Mae cynnwys setiau data ar gyfer cyflyrau iechyd lluosog hefyd yn caniatáu i ni archwilio sut mae mesurau sy'n gyffredin ar draws cyflyrau fel 'absenoldeb ysgol oherwydd iechyd gwael' yn wahanol yn eu heffeithiau yn ôl y math o glefyd.
Bydd y gronfa ddata yn helpu i fynd i'r afael â sut mae mesurau cyflyrau iechyd sy'n benodol i glefydau yn gysylltiedig â phresenoldeb ysgol, cyfranogiad prifysgol a chanlyniadau addysgol. Bydd cyfoeth y data yn caniatáu i ymchwilwyr addasu ar gyfer ffactorau iechyd ac addysgol. Bydd natur arhydol y gronfa ddata yn eu helpu i benderfynu i ba raddau y mae mesurau iechyd yn gysylltiedig â chanlyniadau addysgol dilynol ac, i'r gwrthwyneb, sut mae profiadau addysgol yn gysylltiedig â chanlyniadau iechyd dilynol.
Ymgysylltu â'r cyhoeddMae tîm y prosiect yn gweithio gyda Diabetes UK i gynhyrchu adborth cadarn gan deuluoedd plant â diabetes a'r cyhoedd yn ehangach. Gan y bydd y prosiect yn defnyddio data sensitif a dulliau cymhleth i amddiffyn preifatrwydd, rydym yn gweithio gyda Dr Alex Bailey yng Nghanolfan Cefnogi Rheoleiddioâr Cyngor Ymchwil Feddygol. Byddwn yn cynnig hyfforddiant ar gyfer y grwpiau cleifion i wneud yn siŵr bod goblygiadau cyfreithiol ac ymarferol y fframwaith llywodraethu gwybodaeth yn cael eu deall yn dda. Bydd y rhain yn helpu i lywio ein cyfarfodydd gyda'r Grŵp Cynghori Cyfrinachedd (CAG) yn yr Awdurdod Ymchwil Dynol (HRA), sy'n gyfrifol am gymeradwyo fframwaith y gronfa ddata ymchwil.
Manylion y prosiectArweinydd y prosiect: Dr Robert French, Prifysgol Caerdydd Swm cyllid: £181,211.70 Hyd: 1 Chwefror 2021 - 30 Ebrill 2021
Ariennir y prosiect hwn trwy Gronfa ADR UK Strategic Hub, cronfa bwrpasol ar gyfer comisiynu ymchwil gan ddefnyddio data gweinyddol newydd mewn ymgynghoriad â'r Bwrdd Comisiynu Ymchwil (RCB).
Source -
The personal cost of health conditions in childhood — unknown...
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The personal cost of health conditions in childhood
Where: unstated
When: 2021-2-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This page is also available in Welsh.
ADR UK is funding the creation of an information governance framework for linking child disease-specific health datasets to school and university data for England and Wales.
The study involves the creation of a safe legal pathway for confidential patient information from child health datasets to be securely linked to other sources of data whilst preserving privacy. Once the data linkage process is completed, the data is de-identified before being made available to approved researchers in a secure environment for projects in the public interest.
The information governance framework will be tested with a sample data flow using national diabetes audit datasets. The linkage of other disease-specific datasets is beyond the timeframe of this project, though it is hoped the ground will be prepared for datasets for other child health conditions, starting with the Epilepsy 12 Audit.
The project is led by Cardiff University in collaboration with Diabetes UK, the Royal College of Paediatric and Child Health (RCPCH), University College London and Imperial College London, in partnership with NHS Digital and the Department for Education (DfE), working with the Medical Research Council Regulatory Support Centre (MRC-RSC) and the Office for National Statistics (ONS).
The dataset
Source -
Local Data Spaces: Helping Local Authorities tackle the Covid-19 pandemic — unknown...
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Local Data Spaces: Helping Local Authorities tackle the Covid-19 pandemic
Where: unstated
When: 2021-2-26
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding an initiative to help local authorities across England harness crucial data in the fight against the Covid-19 pandemic.
The Local Data Spaces (LDS) programme is a collaboration between the Joint Biosecurity Centre (JBC), Office for National Statistics (ONS), the Ministry of Housing, Communities and Local Government (MHCLG) and ADR UK.
The dataThe LDS programme is using de-identified Covid-19 data from the national Test and Trace programme alongside health and administrative data from ONS and local authorities themselves, to understand the spread of the pandemic in their areas and its impact on their communities.
âLocal Data Spacesâ are secure, bespoke virtual research areas being created within ONSâs Secure Research Service (SRS). They enable local authorities â and regional groups of authorities â to access the data they need to inform their Covid response and understand its wider impacts.
What questions will this data help to answer?ONS and ADR UK analysts are providing close support to ensure local authorities can get the most useful insights possible from the data to inform decisions.
A team of ADR UK-funded academic researchers from UCL, the University of Leeds and the University of Liverpool also provided analysis on behalf of local authorities in need of greater support, directed by their policy needs, as part of a six-month pilot period ending in April 2021. Research questions explored included:
What are the local drivers of the disproportionate impact of the pandemic on ethnic minorities? What is the local and regional economic impact of the pandemic? What are some of the causes of higher hospitalisation rates among some age groups, such as women aged 20-40, in the second wave?While the analyses conducted by ADR UK-funded researchers was completed in partnership with a group of 25 local authorities, the work was extended to all other local authorities in England to allow them to benefit from the insights generated where relevant. A series of 10 reports for each local authority was therefore produced as a key output of the pilot project, and is now available to access for free on the Consumer Data Research Centre (CDRC) website. Find out more about the reports.
What is the potential impact of this work?Local authorities need to be empowered to make use of the best data available to inform and tailor local responses to the pandemic. However, the data infrastructure and skills available to do so vary greatly across the country.
The LDS programme is helping bring health and economic data together in a more accessible and digestible format for local authorities, with support to interpret the data provided where needed.
Project detailsThis programme of work is funded via the ADR UK Strategic Hub Fund and the ONS core ESRC grant as a key ADR UK infrastructure partner.
A group of four academic researchers were also funded via the Strategic Hub Fund â as additional funding to an existing ESRC investment in the Consumer Data Research Centre (CDRC) â to provide analysis on behalf of local authorities in need of greater support:
Research leads: Maurizio Gibin (UCL), Mark Green (University of Liverpool), Jacob Macdonald (University of Liverpool) and Simon Leech (University of Leeds)
Funding amount: £132,917
Duration: November 2020 â April 2021
Source -
Demographics
Second Generation Surveillance System (SGSS)
Shielded Patient List (SPL)
NPEX (Identifiable) (Direct Care) — COVID Oximetry @home Service Providers*...
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To allow CO@H Providers to identify and refer eligible patients on to the COVID Oximetry @home pathway. — IG-00804_3.1
Recipient Data Controller Organisation(s) : COVID Oximetry @home Service Providers* *Providers are CCGs or health service providers commissioned by CCGs and will include Trusts, GPs and Community Services.
Approval Date: 24/02/2021
Purpose for which the data is being used: To allow CO@H Providers to identify and refer eligible patients on to the COVID Oximetry @home pathway.
Dataset: Demographics Second Generation Surveillance System (SGSS) Shielded Patient List (SPL) NPEX
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Emergency Department Digital Integration (EDDI) - slot bookings data (Aggregate (small numbers not supressed)) (Secondary Uses) — NHS England/Improvement...
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Understanding and assessing impact of 111 First and benefits to reduce Covid infections and risk of nosocomial infection. — IG-00840_9
Recipient Data Controller Organisation(s) : NHS England/Improvement
Approval Date: 26/02/2021
Purpose for which the data is being used: Understanding and assessing impact of 111 First and benefits to reduce Covid infections and risk of nosocomial infection.
Dataset: Emergency Department Digital Integration (EDDI) - slot bookings data
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(1) Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: Legal Obligation â Covid-19 Direction to disseminate
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Second Generation Surveillance System (SGSS)
Hospital Episodes Statistics (HES)
SUS+ (Identifiable) (Secondary Uses) — NHS England/Improvement...
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To identify which children and young people who are admitted to hospital are at increased risk of severe illness or death following Covid-19 infection. — IG-02030
Recipient Data Controller Organisation(s) : NHS England/Improvement
Approval Date: 16/02/2021
Purpose for which the data is being used: To identify which children and young people who are admitted to hospital are at increased risk of severe illness or death following Covid-19 infection.
Dataset: Second Generation Surveillance System (SGSS) Hospital Episodes Statistics (HES) SUS+
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Effectiveness and safety of apixaban vs rivaroxaban in patients with Atrial Fibrillation and Diabetes Mellitus — Samy Suissa ...
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Effectiveness and safety of apixaban vs rivaroxaban in patients with Atrial Fibrillation and Diabetes Mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-18
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jonathan Michaud - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Krishna Roy Chowdhury - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
The effectiveness outcome of interest will be a composite of hospitalisation with an incident ischaemic stroke, transient ischaemic attack or systemic embolism (for simplicity, this composite outcome will be referred to as ischaemic stroke in the remaining of the protocol). The safety outcome of interest will be major bleeding. ICD-10 codes are listed in Appendix 1.
Description: Technical Summary
Patients with both AF and T2DM are at increased risk of stroke compared with patients with AF only. Although DOACs are at least as effective and safe compared to VKAs in patients with AF and T2DM, little is known about whether some DOACs are more effective than others at preventing stroke in this population or associated with a lower risk of bleeding. Thus, we will conduct a population based cohort study to determine the effectiveness and safety of apixaban vs rivaroxaban, the two most commonly used DOACs in the UK, in patients with both AF and T2DM This study will be conducted by linking the CPRD, the HES inpatient database, and the Office for National Statistics (ONS) mortality database. We will form a cohort of patients with non valvular atrial fibrillation (NVAF) and T2DM newly treated with apixaban or rivaroxaban between 2013 and 2020. All patients will be followed until the first of the following events: ischaemic stroke or major bleeding (depending on the outcome being studied), death, oral anticoagulant discontinuation or switch, end of registration with the general practice, or end of the study period. The primary effectiveness outcome of interest will be a composite of hospitalization with incident ischaemic stroke, transient ischaemic attack or systemic embolism. The safety outcome of interest will be major bleeding or death from bleeding. We will use Cox proportional hazards models to estimate hazard ratios with 95% confidence intervals of the outcomes of interest associated with apixaban compared with rivaroxaban. In secondary analyses, we will assess whether this risk varies with duration of use. Propensity score (PS)-based standardised mortality ratio weighting will be used to address confounding. Several sensitivity analyses will be performed to assess the robustness of our results.
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Overactive bladder anticholinergics and risk of incident dementia: a cohort study design using a triangulation approach — Kathryn Richardson ...
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Overactive bladder anticholinergics and risk of incident dementia: a cohort study design using a triangulation approach
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-02
Organisations:
Kathryn Richardson - Chief Investigator - University of East Anglia
Kathryn Richardson - Corresponding Applicant - University of East Anglia
Chris Fox - Collaborator - University of East Anglia
Duncan Edwards - Collaborator - University of Cambridge
Irene Petersen - Collaborator - University College London ( UCL )
Jalesh Panicker - Collaborator - National Hospital for Neurology and Neurosurgery
Katharina Mattishent - Collaborator - University of East Anglia
Louise Robinson - Collaborator - Newcastle University
Nicholas Steel - Collaborator - University of East Anglia
Stuart Irving - Collaborator - Norfolk and Norwich University Hospitals
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Primary: dementia; Secondary: delirium; fracture; stroke; motor vehicle accident
Description: Technical Summary
Previous studies suggest that long-term overactive bladder (OAB) anticholinergic use may increase dementia risk, however studies suffer from residual confounding and protopathic bias. This topic requires more detailed investigation and as identified by the National Institute of Health and Care Excellence.
Aims
1. To describe OAB medication prescriptions trends in England between 2000-2019, by sex and age group.
2. To test whether recurrent OAB anticholinergic prescriptions are associated with increased dementia incidence versus receiving one prescription (separately in men and women). In particular to test whether associations vary by a) cumulative dose, b) specific drugs (compared to oxybutynin), and c) in certain patient groups (e.g. age group, comorbidity).As secondary analyses, to examine whether recurrent OAB anticholinergic prescription is associated with increased risks of:
2d. dementia compared to recurrent prescription of alpha-blockers in men and vaginal oestrogens in women (as active comparators)
2e. stroke (as a negative control outcome)
2f. motor vehicle accidents (to examine confounding by OAB severity)3&4. To examine whether OAB anticholinergic use is associated with delirium and functional decline
Exposure
Prescriptions for OAB anticholinergics (oxybutynin, tolterodine, solifenacin, darifenacin, fesoterodine, propiverine, or trospium) within the first 12 months of therapy.Methods
New user design cohort studies of patients in England prescribed OAB medications since 1998. Dementia incidence (using Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics mortality data) will be compared after applying a 3-year lag period between patients receiving a second OAB prescription to those only receiving one prescription using Cox regression with age as the time-scale. We are using a triangulation approach, hence performing various analyses to see if the findings are consistent with causality and examine confounding and selection biases. This includes additionally examining the outcomes of delirium, fractures and stroke (primarily with exposure as time-varying and no lag period).
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Prevalence, incidence, morbidity and mortality of early-onset type 2 diabetes. — Mary Barker ...
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Prevalence, incidence, morbidity and mortality of early-onset type 2 diabetes.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-23
Organisations:
Mary Barker - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Edward Gregg - Collaborator - Imperial College London
Jack Sargeant - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
⢠Prevalence and incidence of early-onset type 2 diabetes (Appendix 1 - medcodes, ICD-10 codes) (SNOMED codes will also be used in CPRD Aurum);
⢠Characteristics of patients with early-onset type 2 diabetes at diagnosis and during disease trajectory - both cardiovascular risk factors (e.g. obesity, hypertension) and multimorbidity (cardio-renal outcomes, cancer, anxiety, depression);
⢠Incidence of diabetes-related complications (cardio-renal outcomes, cancer) (Appendix 2-5 - medcodes and ICD-10
codes);
⢠All-cause and cause-specific deaths (cardiovascular, renal and cancer-related deaths)Description: Technical Summary
Data from the Clinical Practice Research Datalink (CPRD, GOLD and Aurum), linked to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) data, will be used to investigate the following:
1. The characteristics of patients with early-onset type 2 diabetes at diagnosis and during disease trajectory - both cardiovascular risk factors (e.g. obesity, hypertension) and multimorbidity (cardio-renal outcomes, cancer, anxiety, depression)
2. The prevalence and incidence of early-onset type 2 diabetes between 2000 and the present day
3. The effect of age at type 2 diabetes diagnosis on the incidence of diabetes-associated complications (cardio-renal outcomes, cancer), all-cause and cause-specific mortality (cardiovascular, renal and cancer-related mortality)
Poisson regression models and survival models will be used in the analysis. Analyses will adjust for key covariates including age, sex, ethnicity and socioeconomic status. Ethnicity data will be provided by linkage to HES data and socioeconomic status data will be provided by the linkage to patient level IMD data.
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Developing personalised risk prediction for women at increased risk of Vulval Cancer — Vanitha Sivalingam ...
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Developing personalised risk prediction for women at increased risk of Vulval Cancer
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-01
Organisations:
Vanitha Sivalingam - Chief Investigator - University of Manchester
Vanitha Sivalingam - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Emma Crosbie - Collaborator - University of Manchester
Fiona Walter - Collaborator - University of CambridgeOutcomes:
Outcome1 â Incidence and Prevalence of Lichen Sclerosus, Lichen Planus and Vulval Intraepithelial Neoplasia in England
Outcome 2 â Incidence of vulval squamous cell carcinoma in women with Lichen Sclerosus, Lichen Planus and Vulval Intraepithelial Neoplasia compared with general female population.
Outcome 3- Route of diagnosis of all vulval squamous cell carcinomas and the impact of this on treatment and survival outcomes.Description: Technical Summary
Vulval squamous cell carcinoma (VSCC) is diagnosed in 1300 British women annually. Early detection of vulval cancer reduces surgical morbidity and improves survival. While there is no role for population-based screening, some skin conditions increase the risk of vulval cancer, including lichen sclerosus (LS), lichen planus (LP)] and intraepithelial neoplasia (VIN). A priority research question is âWhat is the risk of developing cancer in lichen sclerosus?". A cancer risk prediction model will help personalise risk, tailor follow-up to reduce intensity of clinician assessments and design population-based interventions.
The four aims of the study are:
1. to establish the incidence and prevalence of lichen sclerosus(LS), lichen planus(LP) and vulval intraepithelial neoplasia(VIN) in adult women using a UK population approach
2. to establish the incidence of VSCC in women with LS, LP and VIN and to compare the risk of VSCC in women at increased risk using a matched-cohort study approach.
3. to establish the interval between diagnosis of a precursor condition (LS, LP and VIN) to the development of VSCC
4. to establish the route of diagnosis of 1st presentation of VSCC and the impact of this on treatment and survival outcomes.Data will be obtained from CPRD Gold and Aurum. Study populations are as follows:
Aim 1: Any woman with a diagnosis of LS or LP between 01/01/1998-30/06/2020.
Aim 2 and 3: Any woman with a diagnosis of LS, LP, VIN and/or vulval cancer between 01/01/1998-31/12/2018 for NCRAS linkage.
Aim 4: Any woman with a diagnosis of LS, LP, VIN and/or vulval cancer between 01/01/2003-31/12/2018 for HES OP linkage.Hazard ratios for outcomes of interest among women with LS/LP/VIN, as compared with female controls, will be estimated from Cox regression models. All analyses will be replicated in an age-matched cohort of women with no history of vulval skin conditions.
Source - and 22 more projects — click to show
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Real world evidence in asthma and chronic obstructive pulmonary disease to understand the burden of COVID-19 infection in United Kingdom — Jil Billy Mamza ...
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Real world evidence in asthma and chronic obstructive pulmonary disease to understand the burden of COVID-19 infection in United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-02
Organisations:
Jil Billy Mamza - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Laura Pasea - Corresponding Applicant - University College London ( UCL )
Adrian Rabe - Collaborator - Imperial College London
Alvina Lai - Collaborator - University College London ( UCL )
Amitava Banerjee - Collaborator - University College London ( UCL )
Mehrdad Alizadeh Mizani - Collaborator - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Spiros Denaxas - Collaborator - University College London ( UCL )
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
⢠Death (all cause, COVID-19, non-COVID-19, respiratory, cardiovascular)
⢠COVID-19 infection (hospitalised versus non-hospitalised)
⢠Intubation/mechanical ventilation
⢠Pneumonia
⢠Asthma-related healthcare utilisation
⢠COPD-related healthcare utilisation
⢠Sepsis
⢠Stroke/TIA
⢠Intensive care unit admission (all cause, asthma-related, COPD-related)
⢠Hospital admissions and re-admissions (all cause, asthma-related, COPD-related)
⢠Hospital admission length (all cause, asthma-related, COPD-related)
⢠Outpatient attendances (all cause, asthma-related, COPD-related)
⢠Days alive out of hospitalDescription: Technical Summary
The coronavirus pandemic has had unprecedented effects on all aspects of society. As health system responses grapple with second waves and roll-out of vaccination, it is important to understand the actual impact on individuals with long-term conditions. In this project, we intend to use CPRD linked database to better understand the impact of the coronavirus pandemic on individuals with chronic obstructive pulmonary disease (COPD) and asthma. Using a cohort of these patients, we will describe the epidemiology of COVID-19 in this population in terms of incidence and prevalence across different severity levels of COVID-19 and severity classes of asthma and COPD. In addition, we will determine COVID-19-related and all-cause clinical and healthcare resource use outcomes among these patients, including the demographic, disease-related, comorbidity-related, and treatment-related factors associated with mortality, COVID-19-related complications and the incurring of healthcare resource use. This study will utilise both CPRD Aurum and CPRD GOLD database and the study period will begin on 1 January 2010 until the last GPâs collection day. Each of the clinical outcomes of interest will be described separately. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Relative risks and risk factors associated with outcomes will be estimated using Cox regression models. In addition, we aim to further evaluate the care pathways of the patients to understand the health resource use and the financial cost of the direct and indirect burden of disease, including hospital admission, ITU admission and GP visits. Such evidence will be used to highlight any unmet treatment needs and inform modelling of the impact of the pandemic in other patient subpopulations, and will aid planning for future pandemics.
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Moderating effects of intellectual disabilities on mortality among people with autism: a retrospective cohort study of a national sample of primary-care patients in England using the Clinical Practice Research Datalink — Ewelina Rydzewska ...
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Moderating effects of intellectual disabilities on mortality among people with autism: a retrospective cohort study of a national sample of primary-care patients in England using the Clinical Practice Research Datalink
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-11
Organisations:
Ewelina Rydzewska - Chief Investigator - University of Glasgow
Ewelina Rydzewska - Corresponding Applicant - University of Glasgow
Andrew Stanfield - Collaborator - University of Edinburgh
Bhautesh Jani - Collaborator - University of Glasgow
Claire Moir - Collaborator - Not from an Organisation
Craig Meville - Collaborator - University of Glasgow
Deborah Kinnear - Collaborator - University of Glasgow
Iain Carey - Collaborator - St George's, University of London
James Cusack - Collaborator - Autistica
Jill Pell - Collaborator - University of Glasgow
Michael Fleming - Collaborator - University of Glasgow
Sarah Cassidy - Collaborator - University of NottinghamOutcomes:
All-cause and cause-specific mortality
Description: Technical Summary
Risk of premature mortality has been reported to be elevated among individuals with autism, compared with the general population and healthy cousin or sibling controls, but evidence on all-cause and cause-specific mortality amongst the population with autism in the UK is still lacking. People with autism are more likely to have co-occurring intellectual disabilities, but large-scale epidemiological studies investigating intellectual disabilities as a moderator of mortality in this population are also scarce. To date, only two studies have analysed the differences in mortality between individuals with autism with and without co-occurring intellectual disabilities and reported inconsistent findings. In most previous studies, sample sizes have been too small to compare mortality in individuals with autism with and without co-occurring intellectual disabilities reliably, so the potentially moderating effect of intellectual disabilities on mortality and causes of death in autism remains understudied. The aim of this project will be to investigate all-cause and cause-specific mortality in a nationwide sample of primary care patients with and without autism and examine if co-occurring intellectual disabilities increase the risk of death in patients with autism.
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Artificial intelligence for identifying new disease clusters in patients with immune-mediated inflammatory conditions: A Proof-of-Concept Study — Prasad Nishtala ...
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Artificial intelligence for identifying new disease clusters in patients with immune-mediated inflammatory conditions: A Proof-of-Concept Study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-25
Organisations:
Prasad Nishtala - Chief Investigator - University of Bath
Prasad Nishtala - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Jenny Humphreys - Collaborator - University of Manchester
John Pauling - Collaborator - University of Bath
Julia Snowball - Collaborator - University of Bath
Mahesan Niranjan - Collaborator - University of Southampton
Neil McHugh - Collaborator - University of Bath
Olga Isupova - Collaborator - University of Bath
Sandipan Roy - Collaborator - University of Bath
Sarah Skeoch - Collaborator - University of Bath
Visakan Kadirkamanathan - Collaborator - University of Sheffield
William Tillett - Collaborator - University of BathOutcomes:
This descriptive study will not measure clinical outcomes.
A description of the following outcomes will be reported:
⢠Prevalence of clusters of long-term conditions (LTCs) in the IMID population.
⢠Types of LTCs clusters in the IMID population.
⢠Prevalence of clusters of LTCs in the IMID population by age, sex and ethnicity.
⢠The life course of the clusters of LTCs in the IMID population.Description: Technical Summary
The overall prevalence of immune-mediated inflammatory conditions (IMIDs) is estimated to affect 1 in 10 people in Europe and the United States. The most common IMIDs include rheumatoid arthritis (RA), inflammatory bowel disease, systemic lupus erythematosus, psoriasis, systemic sclerosis, and psoriatic arthritis (PsA). Although the epidemiology of multimorbidity in the RA population is well characterised, it is poorly understood in other IMIDs. Our study's overarching aim is to leverage longitudinal primary care health data from a comprehensive electronic health record database, Clinical Practice Research Datalink (CPRD), to characterise the epidemiology of clusters of medical conditions amongst the IMID population. There are significant gaps in our understanding of which cluster of medical conditions occur commonly together in the IMID population and whether these clusters vary over the life course. There is an urgent, yet unmet need to accurately identify clusters of medical conditions in IMIDs and understand their life course.
The CPRD comprises 50 million patients, including 15 million currently registered patients in GP practices across the UK, with up to 15 years follow-up. We will define "multimorbidity" as the presence of two or more diseases in an individual without reference to any index disease, and the study will focus on patients with complex multiple long-term conditions. We will analyse 40 long-term conditions outlined by Barnett et al. to identify and interpret key and complex multimorbidity clusters. We propose a diverse range of clustering methods as a potential technique to characterise the complex interactions of multimorbidity. We will explore the clusters by age, sex and ethnicity in the IMID population.
Our study will identify disease clusters in the IMID population in the short-term, which will help tailor specific interventions to manage multimorbidity. In the long-term, the findings will inform the design of a longitudinal study using inception cohorts of IMID patients.
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Evaluation of de novo diabetes or diabetes worsening in metastatic castration resistant prostate cancer patients treated with abiraterone acetate compared with enzalutamide in England. — Amit Kiran ...
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Evaluation of de novo diabetes or diabetes worsening in metastatic castration resistant prostate cancer patients treated with abiraterone acetate compared with enzalutamide in England.
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-09
Organisations:
Amit Kiran - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Kirsten Leyland - Collaborator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Collaborator - Astellas Pharma Europe Ltd. - UK
Robert Snijder - Collaborator - Astellas Pharma Europe Ltd. - UKOutcomes:
Composite outcome of incident T2DM diagnosis or worsening T2DM; Duration of treatment on AA or enzalutamide; Incident T2DM diagnosis; Worsening T2DM
Description: Technical Summary
Prostate cancer is the second most common cancer worldwide and the fifth most common cause of death. It is the most frequently diagnosed cancer among men in the United Kingdom (UK) with 48,487 new cases reported in 2017, accounting for 26% of all male cancer diagnoses. Prostate cancer encompasses a spectrum of clinical states that a patient progresses through over time.
Metastatic castrate-resistant prostate cancer (mCRPC), is an advanced, incurable form of the disease. Abiraterone acetate (AA) and enzalutamide (Enza) are key treatment options which exert their anticancer effects through different mechanisms of action. AA uses concomitant corticosteroid administration as a prophylactic measure. ENZA does not require concomitant corticosteroids as it acts directly on the androgen receptor without affecting the steroid pathways
Whilst it is well known that long-term corticosteroid use is associated with unwanted side effects including disturbance of glucose metabolism, there has been limited reporting on the risk of T2DM in susceptible patients such as mCRPC.
This study aims to describe the risk of T2DM (incident diagnosis or worsening progression) in mCRPC patients in England, treated with AA compared with Enza.
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Association between weight loss and healthcare resource utilization in adults living with obesity — Christiane L Haase ...
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Association between weight loss and healthcare resource utilization in adults living with obesity
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-09
Organisations:
Christiane L Haase - Chief Investigator - Novo Nordisk
Christiane L Haase - Corresponding Applicant - Novo Nordisk
Camilla Morgen - Collaborator - Novo Nordisk
Chris Bojke - Collaborator - University of Leeds
Jonathan Pearson-Stuttard - Collaborator - Imperial College London
Niels Væver Hartvig - Collaborator - Novo Nordisk
Sandra Lopes - Collaborator - Novo Nordisk
Tugce Kalayci Oral - Collaborator - Novo Nordisk
Volker Schnecke - Collaborator - Novo NordiskOutcomes:
The outcomes are rates or costs of healthcare resource utilization per year after start of follow-up as measured in eleven different ways:
⢠Total number of primary care practitioner (PCP) contacts per year
⢠Total number of outpatient clinic contacts per year
⢠Total number of prescriptions per year
⢠Number of inpatient hospital days per year
⢠Number of critical care bed days per year
⢠Total number of hospital admissions per year
⢠Total cost of PCP contacts per year
⢠Total cost of outpatient clinic contacts per year
⢠Total cost of prescriptions per year
⢠Total cost of hospitalizations per year
⢠Total cost of care per yearDescription: Technical Summary
Technical summary
Obesity is a chronic disease with a considerable clinical, societal, public health and economic impact. A higher body mass index (BMI) has been shown to associate with higher risk of numerous obesity-related outcomes as well as higher healthcare resource utilization and costs.
In a recent observational, database study based on the UK CPRD:HES, we showed that intentional weight loss (range 10-25%) was associated with a reduced risk of developing a number of obesity-related outcomes, when compared to keeping a stable, high weight, among people with obesity. Evaluations of bariatric surgery among people with obesity indicate that clinical benefits of weight management may translate into less healthcare resource utilization, however this has not been well quantified for intentional weight loss among people with obesity, independent of type of weight management intervention.
The objective of this study is to evaluate the effect of >10% intentional weight loss on healthcare resource utilization and costs among people living with obesity (BMI>30), with the hypothesis that intentional weight loss (median over the range of 10-25%) among people living with obesity associates with lower health care resource utilization and reduced healthcare costs when compared to people with obesity and stable weight. This will be examined using a prospective observational cohort design. A variety of measures of healthcare resource utilization and costs will be included as outcomes to capture different aspects of healthcare use, e.g. short term (primary care visits, prescriptions) and longer term (hospitalizations). We will use adjusted general linear models to estimate the difference in rates and costs, respectively, in healthcare resource utilization and costs between groups over time.
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Investigating whether in utero exposure to maternal psychotropic medication is associated with adverse pregnancy outcomes and adverse health and neurodevelopmental outcomes in offspring — Michael Fleming ...
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Investigating whether in utero exposure to maternal psychotropic medication is associated with adverse pregnancy outcomes and adverse health and neurodevelopmental outcomes in offspring
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-15
Organisations:
Michael Fleming - Chief Investigator - University of Glasgow
Michael Fleming - Corresponding Applicant - University of Glasgow
Claire Hastie - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
David Blane - Collaborator - University of Glasgow
James McLay - Collaborator - University of Aberdeen
Jill Pell - Collaborator - University of GlasgowOutcomes:
Pregnancy outcomes of interest include spontaneous abortion, fetal death and stillbirth.
For live births, birth outcomes include premature birth, low birthweight, mode of delivery, Apgar score, congenital anomalies and infant death, whilst child outcomes include increased hospitalisation and mortality, chronic conditions such as asthma and diabetes, and neurodevelopmental conditions such as autism and ADHD.Description: Technical Summary
We will investigate pregnancy and child outcomes for women prescribed psychotropic medications during pregnancy (medications within BNF Chapter 4 including those prescribed for anxiety [BNF 4.1], psychosis [BNF 4.2], depression and mood disorder [BNF 4.3], ADHD [BNF 4.4], and epilepsy [BNF 4.8]) compared to a) women with the underlying conditions of interest who did not receive corresponding psychotropic medication and b) women who did not have these underlying conditions and did not receive psychotropic medication. We will ascertain women with pregnancies ending between 1st January 1991 and 31st December 2020 and link mother's Clinical Practice Research Datalink (CPRD) primary care and prescribing data to their children's CPRD primary care and prescribing, Hospital Episode Statistics (HES) inpatient admission, and Office for National Statistics (ONS) death data.
Outcomes will be analysed using:
Binary logistic regression â spontaneous abortion (y/n), fetal death (y/n), stillbirth (y/n), infant death (y/n), congenital anomaly (y/n), specific types of congenital anomaly (y/n), low birthweight (y/n), preterm birth (y/n), asthma (y/n), diabetes (y/n), autism (y/n), ADHD (y/n), depression (y/n), other neurodevelopmental conditions (y/n).
Ordinal logistic regression â birthweight categories, gestational age categories, Apgar score categories.
Multinomial logistic regression â mode of delivery.
Poisson regression / negative binomial regression â number of hospital admissions, length of hospital stays.
Cox proportional hazards regression / Poisson piecewise regression â hospitalisation, mortality.
Primary care data will enable identification of untreated disease to differentiate effects of medication from effects of the underlying condition. Where powered, we will do sub-group analyses of medicated women: continued medication during pregnancy; stopped medication during pregnancy; and started medication during pregnancy. We will investigate any critical time of exposure (1st, 2nd or 3rd trimester) and relationships with dose or duration of medication.
We will adjust for confounders detailed in the 'exposures, outcomes and covariates' section.
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The Comparative Safety of Acid Suppressant Drugs: Is there an Increased Risk of Colorectal Cancer? — Samy Suissa ...
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The Comparative Safety of Acid Suppressant Drugs: Is there an Increased Risk of Colorectal Cancer?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-25
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Alan Barkun - Collaborator - McGill University
Devin Abrahami - Collaborator - McGill University
Emily McDonald - Collaborator - McGill University
Mireille Schnitzer - Collaborator - University Of MontrealOutcomes:
The primary outcome is incident colorectal cancer, which will be identified using Read codes (Appendix I).
The secondary outcome will consider colon and rectal cancers separately.
Description: Technical Summary
Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are acid suppressant drugs used in the management of several gastric conditions. While both drug classes are among the most prescribed drugs worldwide, emerging evidence suggests that PPIs are inappropriately used and overprescribed in certain patient populations. This increased uptake is especially concerning in light of potential serious adverse outcomes that have been associated with their use, including a potential association with colorectal cancer. Indeed, chronic acid suppression through continuous PPI use causes hypergastrinemia, which is known to be associated with colorectal cancer. To date, the few observational studies that have investigated this potential association had important methodological shortcomings. Thus, the objective of this large population-based cohort study is to address whether use of PPIs, compared to use of H2RAs, is associated with an increased risk of colorectal cancer.
To address this, we will assemble a cohort of patients newly treated with PPIs or H2RAs between January 1, 1990 (the first full year that both drugs were available) and April 30, 2018, with follow-up until April 30, 2019. Cohort entry will be defined as the date of this first prescription during the study period. To minimize confounding by indication, PPI users will be compared to H2RAs, an active comparator, and the cohort will be reweighed using propensity scores. Given the insidious nature of the outcome and to minimize the potential for reverse causality, all patients will be followed starting one year after cohort entry, until an incidence diagnosis of colorectal cancer, death, end of data availability, or April 30, 2019, whichever occurs first. Cox proportional hazards models will be used to estimate weighted hazard ratios and 95% confidence intervals of colorectal cancer associated with the use of PPIs, compared with use of H2RAs.
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The direct and indirect effects of Covid-19 on long-term conditions: A retrospective cohort study using primary and secondary care electronic health records — Krishnarajah Nirantharakumar ...
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The direct and indirect effects of Covid-19 on long-term conditions: A retrospective cohort study using primary and secondary care electronic health records
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Admitted Patient Care; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-22
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Jennifer Cooper - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Astha Anand - Collaborator - University of Birmingham
Christopher Sainsbury - Collaborator - Gartnavel Hospital
Francesca Crowe - Collaborator - University of Birmingham
Neeraj Bhala - Collaborator - University Hospitals Birmingham
Shamil Haroon - Collaborator - University of BirminghamOutcomes:
Study 1: Outcomes for the Retrospective Cohort Analysis include:
Incidence of predefined long-term health conditions (autoimmune diseases, chronic kidney disease (CKD), cardiovascular disease (CVD), diabetes, gastrointestinal and liver diseases, haematological diseases, mental health diseases, neurological diseases, and respiratory diseases); and hospitalisation related to each specific long-term health condition.Study 2: Outcomes for Interrupted Time Series include
Incidence of SARS-CoV-2 infection; hospitalisation for SARS-CoV-2 infection; disease-specific measures of clinical management of long-term health conditions including biochemical biomarkers of disease and blood pressure, rate of medication prescription, occurrence of disease-specific clinical reviews, rate of referral to specialist care or service; cause-specific mortality; and all-cause mortality.Study 3: Outcomes of Retrospective cohort analysis include:
SARS-CoV-2 infection; hospitalisation for SARS-CoV-2 infection; mortality associated with SARS-CoV-2 infection.Description: Technical Summary
This study comprises three interrelated studies which, overall, aim to assess the direct effects of a SARS-CoV-2 infection, and the indirect effects of the COVID-19 pandemic on the diagnosis and management of chronic conditions.
Firstly, we will use a series of retrospective cohort studies to analyse the short-term effects of SARS-CoV-2 infection on risk of developing common chronic diseases including autoimmune diseases, chronic kidney disease (CKD), cardiovascular disease (CVD), diabetes, gastrointestinal and liver diseases, haematological diseases (including venous thromboembolism), mental health diseases, neurological diseases, and respiratory diseases. These cohort studies will use descriptive statistics and Cox proportional hazard models to examine the association between SARS-CoV-2 infection and the incidence of each of these chronic diseases, adjusted for sociodemographic and clinical characteristics characteristics.
Secondly, for those already diagnosed with these long-term conditions, we will use controlled interrupted time series analysis to assess any change in disease-specific measurements of clinical management, and rates of prescriptions and referrals during 2020 compared with the three years preceding the COVID-19 pandemic, with particular reference to March 23rd 2020, when the first lockdown was announced.
Finally, using Cox proportional hazard models we will assess whether the severity of the long-term conditions at baseline predicts the hazard of infection with SARS-CoV-2, and subsequent hospitalisation and mortality. These models will be stratified by sex and we will adjust for sociodemographic characteristics and other risk factors for SARS-CoV-2 infection.
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Prognostic significance of initiating loop diuretics and its relationship to heart failure — John Cleland ...
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Prognostic significance of initiating loop diuretics and its relationship to heart failure
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-16
Organisations:
John Cleland - Chief Investigator - University of Glasgow
Jocelyn Friday - Corresponding Applicant - University of Glasgow
Fraser Graham - Collaborator - University of Glasgow
Maria Wolters - Collaborator - University of Edinburgh
Pierpaolo Pellicori - Collaborator - University of GlasgowOutcomes:
Prevalence rates of heart failure and/or repeat loop diuretic prescriptions 2001-2003; Incident diagnosis of heart failure and/or repeat loop diuretic use and the temporal patterns in diagnosis from 2004-2017; Hospitalisation, all-cause, cardiovascular and for heart failure. All-cause mortality with follow-up through 2019; and cardiovascular and non-cardiovascular mortality with follow-up through 2019. Place of death from the death certificate.
Baseline characteristics, comorbidities and concurrent medications are defined using a priori code lists provided in Appendices B, C, and D.
Baseline characteristics, comorbidities and concurrent medications are defined using a priori code lists provided in Appendices B, C, and D.
Description: Technical Summary
This study has two parts, to:
1. calculate patterns of prevalent and incident cases of heart failure and/or loop diuretic use in the UK.
2. compare characteristics, comorbidities, concurrent medications, hospitalisation and mortality rates in incident cases (defined above) against a sex, age, and geographically matched control group.1: We will calculate the prevalence and incidence of cases amongst adults (age >18 years) in CPRD Aurum, Hospital Episode Statistics (HES) admitted and patient records. Standardized rates will be calculated using age and sex for the 2013 European Standard Population. Time-dependent covariates and Poisson regression with robust standard errors will be used to estimate overall and category-specific incidence ratios.
2: A sex, age, and geographically matched control group as case-control for our cohort. All-cause and cardiovascular mortality and place of death will be identified from ONS Death Registrations. Patient sex, age, body mass index (BMI), systolic and diastolic blood pressure, serum creatinine, standard haematology and biochemistry profiles (eg:- haemoglobin, sodium, creatinine, albumin), indices of iron deficiency (eg:- ferritin), smoking status, diagnostic care-setting, comorbidities (atrial fibrillation, hypertension, ischaemic heart disease and myocardial infarction, peripheral artery disease, stroke, chronic respiratory disease, anaemia, iron deficiency, hyponatraemia, cancer, chronic kidney disease, dementia, depression, diabetes mellitus, dyslipidaemia, obesity, osteoarthritis, thyroid disorder), concurrent medications (acetazolamide, renin-angiotensin-aldosterone system inhibitors, beta blockers, calcium channel blockers, digoxin, thiazides and related, low dose aspirin, warfarin, insulin, other treatments for diabetes mellitus, bronchodilators, lipid regulating medications, thyroid disorder medications, non-steroidal anti-inflammatory agents, depression medication, oral steroids, gastroprotectants, and opioids/opiates) will be extracted from primary care and HES records as appropriate. Competing risk analysis will be use to study all-cause, cardiovascular and heart failure hospitalisations. Cox proportional hazards regression will be used to study all-cause and cardiovascular mortality.
When applicable, we will adjust the models for age, sex, region and socioeconomic status.
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COVID-19 recording in Clinical Practice Research Datalink primary care data and linked Second Generation Surveillance System SARS-CoV-2 virology test data — Eleanor Yelland ...
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COVID-19 recording in Clinical Practice Research Datalink primary care data and linked Second Generation Surveillance System SARS-CoV-2 virology test data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-11
Organisations:
Eleanor Yelland - Chief Investigator - CPRD
Eleanor Yelland - Corresponding Applicant - CPRD
Rachael Williams - Collaborator - CPRD
Susan Hodgson - Collaborator - CPRDOutcomes:
Record of positive SARS-CoV-2 test in the SGSS linked data; Record of SARS-CoV-2 test (positive, negative, or inconclusive) or COVID-19 diagnosis code in the primary care data
Description: Technical Summary
CPRD provide de-identified primary care data for public health research. In light of the COVID-19 global pandemic, linkage to the Public Health England (PHE) Second Generation Surveillance System (SGSS) SARS-CoV-2 positive virology pillar 1 test data was established. The added value of these data is currently poorly understood. We will establish the agreement of primary care recording around COVID-19 and the linked SGSS SARS-CoV-2 positive test data. This will assess the added value of the SGSS-linkage and contribute to our understanding of how well COVID-19 diagnoses are being recorded in primary care data. This knowledge is crucial to support research into COVID-19 using these data sources, which in turn can inform our understanding of the disease and inform patient care and public health policy.
All patients in CPRD Aurum and CPRD GOLD eligible for linkage to the SGSS SARS-CoV-2 test data and who have at least one day of registration between March 2020 and the end of the SGSS coverage period (currently July 2020) will be included.
We will describe the COVID-19 case status data available via the primary care record, and that available via the linked SGSS data in terms of numbers of events, age, gender, practice region, ethnicity, and patient-level IMD quintile.
Two measures of agreement between the recording of positive SARS-CoV-2 diagnoses in primary care and the SGSS pillar 1 testing data will be estimated. The proportion of patients with a record indicating a COVID-19 diagnosis in the primary care data who also have a positive SARS-CoV-2 test record in SGSS data will be estimated as the first measure.
The proportion of patients within the cohort with a positive SARS-CoV-2 test record in the SGSS data who also have a record indicating a COVID-19 diagnosis in the primary care data will be estimated as the second measure.
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Risk of tendon disorders and Psoriatic arthritis with fluoroquinolone prescriptions in Psoriasis patients — Bhautesh Jani ...
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Risk of tendon disorders and Psoriatic arthritis with fluoroquinolone prescriptions in Psoriasis patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-10
Organisations:
Bhautesh Jani - Chief Investigator - University of Glasgow
Bhautesh Jani - Corresponding Applicant - University of Glasgow
Barbara Nicholl - Collaborator - University of Glasgow
Frances Mair - Collaborator - University of Glasgow
Fraser Morton - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Mohammad H Derakhshan - Collaborator - University of Glasgow
Philip McLoone - Collaborator - University of Glasgow
Srinivasa Vittal Katikireddi - Collaborator - University of Glasgow
Stefan Siebert - Collaborator - University of GlasgowOutcomes:
1. Tendinopathy or any tendon related disorder;
2. Psoriatic arthritis (PsA)Description: Technical Summary
People with psoriasis have an increased risk of tendon problems and up to a third will develop psoriatic arthritis (PsA) which is characterised by inflammation of tendons and joints. There have been advances in understanding the underlying immunology of these conditions which has led to effective treatments. However, many patients do not respond to these therapies and it remains unclear why some people with psoriasis develop these tendon problems and PsA while many others do not. It is likely that factors other than immune dysfunction may also play an important role in precipitating these musculoskeletal issues in people with psoriasis. Fluoroquinolone antibiotics have been shown to have a direct effect on tendons and are associated with an increased risk of tendon injury and rupture in the general population but again it is not known why this only affects some people.
We hypothesis that fluoroquinolone antibiotics may be a trigger for tendinopathy and also PsA in people with psoriasis, who are already at increased risk of these as a result of their inflammatory skin condition.
Using the linked longitudinal prescription and GP data, we will use logistic regression models to evaluate whether people with an existing diagnosis of psoriasis (without PsA) who have received fluoroquinolones are at increased risk of subsequently developing tendon problems in general and PsA in particular compared to people with psoriasis (without PsA) who have never received these antibiotics. We will also adjust for potential covariates and confounders.
If this association is confirmed, this would have important policy implications as fluoroquinolones should then be avoided in people with psoriasis, while a history of previous fluoroquinolone exposure may also help identify those at increased risk of PsA, prompting earlier referral to specialist services and treatment, leading to improved outcomes for patients.
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Investigating whether in utero exposure to maternal antihypertensive medication is associated with adverse pregnancy outcomes and adverse health and neurodevelopmental outcomes in offspring — Michael Fleming ...
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Investigating whether in utero exposure to maternal antihypertensive medication is associated with adverse pregnancy outcomes and adverse health and neurodevelopmental outcomes in offspring
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-10
Organisations:
Michael Fleming - Chief Investigator - University of Glasgow
Michael Fleming - Corresponding Applicant - University of Glasgow
Claire Hastie - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
David Blane - Collaborator - University of Glasgow
James McLay - Collaborator - University of Aberdeen
Jill Pell - Collaborator - University of GlasgowOutcomes:
Pregnancy outcomes of interest include spontaneous abortion, fetal death and stillbirth.
For live births, birth outcomes include premature birth, low birthweight, mode of delivery, Apgar score, congenital anomalies and infant death, whilst child outcomes include increased hospitalisation and mortality, chronic conditions such as asthma and diabetes, and neurodevelopmental conditions such as autism and ADHD.Description: Technical Summary
We will investigate pregnancy and child outcomes for women prescribed antihypertensive medications during pregnancy compared to a) women with hypertension who did not receive antihypertensive medication and b) women who did not have hypertension and did not receive antihypertensive medication. We will ascertain all women with pregnancies ending between 1st January 1991 and 31st December 2020 and link mother's Clinical Practice Research Datalink (CPRD) primary care and prescribing data to their children's CPRD primary care and prescribing, Hospital Episode Statistics (HES) inpatient admission, and Office for National Statistics (ONS) death data.
Outcomes will be analysed using:
Binary logistic regression â spontaneous abortion (y/n), fetal death (y/n), stillbirth (y/n), infant death (y/n), congenital anomaly (y/n), specific types of congenital anomaly (y/n), low birthweight (y/n), preterm birth (y/n), asthma (y/n), diabetes (y/n), autism (y/n), ADHD (y/n), depression (y/n), other neurodevelopmental conditions (y/n).
Ordinal logistic regression â birthweight categories, gestational age categories, Apgar score categories.
Multinomial logistic regression â mode of delivery.
Poisson regression / negative binomial regression â number of hospital admissions, length of hospital stays.
Cox proportional hazards regression / Poisson piecewise regression â hospitalisation, mortality.
Primary care data will enable us to identify untreated disease and therefore differentiate the effects of medication from effects of the underlying condition. Where powered to do so, we will also do sub-group analyses of those on medication: continued medication during pregnancy; stopped medication during pregnancy; and started medication during pregnancy. We will investigate whether there is a critical time of exposure (1st, 2nd or 3rd trimester) and any relationship with dose or duration of medication.
We will adjust for the confounders detailed in the 'exposures, outcomes and covariates' section. These will additionally include pre-existing physical conditions such as diabetes (type 1 and type 2) and thyroid disease and pregnancy complications such as hyperemesis gravidarum
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Sulfonylureas versus metformin as initial treatment for type 2 diabetes and the risk of ventricular arrhythmia: A population-based cohort study — Samy Suissa ...
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Sulfonylureas versus metformin as initial treatment for type 2 diabetes and the risk of ventricular arrhythmia: A population-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Nehal Islam - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Our outcomes of interest include: Ventricular Arrhythmia (Fatal or Non-Fatal), Cardiac Arrest (Fatal or Non-Fatal), and Sudden Cardiac Death
Description: Technical Summary
Sulfonylureas are frequently used as a firstâline treatment in patients with type 2 diabetes who are intolerant or have a contraindication to metformin. While previous studies have identified an increased risk of cardiovascular death with sulfonylureas, the underlying cause of this increased risk remains unclear. Sulfonylureas are known to increase the risk of hypoglycaemia relative to other oral antidiabetic drugs. One possibility is an increased risk of fatal hypoglycaemia-induced ventricular arrhythmias. We will therefore conduct a retrospective, population-based cohort study. This cohort will include patients with type 2 diabetes in the Clinical Practice Research Datalink (CPRD) AURUM (linked to Hospital Episode Statistics and Office for National Statistics) receiving sulfonylureas or metformin as their first-ever antidiabetic drug prescription. In the primary analysis, exposure will be defined using an as-treated definition. Patients will be followed from cohort entry until an event, discontinuation of cohort entry medication, initiation of another antidiabetic drug, end of study period, or administrative censoring. For our first objective, the primary endpoint will be fatal or non-fatal ventricular arrhythmia. We will use Cox proportional hazards models to estimate hazard ratios for ventricular arrhythmia with current use of sulfonylureas relative to current use of metformin. To minimize confounding, Cox models will be inverse weighted by high-dimensional propensity scores. In secondary analyses, we will examine whether duration of use, sulfonylurea molecule, age, sex, history of cardiovascular disease, and haemoglobin (HbA1c) level modify the association between current use of sulfonylureas and the risk of ventricular arrhythmia, relative to metformin. We will also investigate rates of cardiac arrest, fatal ventricular arrhythmia, and sudden cardiac death between treatment groups. In addition, we will use a marginal structural model to examine potential mediation of the association between sulfonylurea versus metformin and the risk of ventricular arrhythmias by the occurrence of hypoglycaemia.
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Association of physical conditions with challenging behaviours in people with intellectual disabilities: a longitudinal cohort study of a national sample of primary-care patients in England using the Clinical Practice Research Datalink — Ewelina Rydzewska ...
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Association of physical conditions with challenging behaviours in people with intellectual disabilities: a longitudinal cohort study of a national sample of primary-care patients in England using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-16
Organisations:
Ewelina Rydzewska - Chief Investigator - University of Glasgow
Ewelina Rydzewska - Corresponding Applicant - University of Glasgow
Angela Henderson - Collaborator - University of Glasgow
Anne MacDonald - Collaborator - University of Glasgow
Craig Meville - Collaborator - University of Glasgow
Elita Smiley - Collaborator - GREATER GLASGOW AND CLYDE
Iain Carey - Collaborator - St George's, University of London
Michael Fleming - Collaborator - University of Glasgow
Richard Hastings - Collaborator - University of Warwick
Umesh Chauhan - Collaborator - University Of Central LancashireOutcomes:
Primary outcome: challenging behaviours as defined through READ codes in Appendix 1
Moderator: record of co-occurring physical conditions (i.e. pain, sleep problems, constipation, epilepsy, urinary/bowel incontinence and sensory impairments) as defined through READ codes
Mediators: severity of intellectual disabilities, co-occurring autism/genetic syndromes/mental comorbidities as defined through READ codes in Appendix 1
Confounding covariates: demographic (age, gender, ethnicity) and socioeconomic (Practice/Patient Level Index of Multiple Deprivation) factors
Description: Technical Summary
Challenging behaviours can include physically, verbally or sexually aggressive, destructive or self-injurious behaviour. The estimated prevalence of challenging behaviour problems in intellectual disabilities in large population studies shows considerable variation between 4â22%, with multiple factors likely to underlie challenging behaviours in this population. Risk factors associated with challenging behaviours in people with intellectual disabilities include male gender, severe/profound level of intellectual disabilities, co-occurring autism and deficits in receptive and expressive communication. An association with behavioural, psychiatric and psychosocial factors has also been established, but physical conditions such as pain, sleep problems, constipation, epilepsy, urinary/bowel incontinence and sensory impairments have been less studied and existing evidence is mostly of low quality and inconclusive. In this study, we will investigate the incidence of challenging behaviours in a large nationwide population of primary care patients with intellectual disabilities in England. Using stratified Cox proportional hazard models, we will also examine the association between challenging behaviours and physical conditions (i.e. pain, sleep problems, constipation, epilepsy, urinary/bowel incontinence and sensory impairments) in this population, including exploring how different health (e.g. severity of intellectual disabilities, co-occurring autism/genetic syndromes/mental comorbidities), demographic (e.g. age, gender, ethnicity) and socioeconomic (e.g. Practice/Patient Level Index of Multiple Deprivation) factors may affect this relationship.
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CharacTeristics of treAtment response to hIgh dose inhaled corticosteroids(ICS)+Long acting B2 agonist(LABA) vs medium or high dOse ICS+LABA+long acting muscarinic antagonist in patients with uncontRolled moderate to severe asthma on medium dose ICS+LABA — Daniel Prieto...
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CharacTeristics of treAtment response to hIgh dose inhaled corticosteroids(ICS)+Long acting B2 agonist(LABA) vs medium or high dOse ICS+LABA+long acting muscarinic antagonist in patients with uncontRolled moderate to severe asthma on medium dose ICS+LABA
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-24
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Eng Hooi Tan - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Katia Verhamme - Collaborator - Erasmus University Medical Center ( EMC )Outcomes:
The following outcomes will be investigated:
Asthma treatment response: Response is defined as a â¥25% reduction in severe asthma exacerbation rate (in the 12 months follow-up from treatment step-up) compared to the exacerbation rate in the 12 months prior to treatment step-up
AND/OR
improvement of â¥7.5% of FEV1% compared to baseline FEV1% in combination with an absolute improvement of FEV1 compared to baseline of 100 mL. (with a sensitivity analysis for improvement of 50 mL).
To define treatment response, information on lung function and information on severe asthma exacerbations is important. A severe asthma exacerbation is defined as use of acute systemic corticosteroids, ED visit, and/or hospitalisation for reasons of asthma exacerbation.(1)
Treatment patterns: (treatment discontinuation, treatment step-down or switch). Patients will be considered as discontinuing GINA treatment step-up in case the respective treatment discontinues or in case there is more than 60 days between two episodes of the same GINA treatment step-up. The number of patients discontinuing treatment will be described (proportion of total number of asthma individuals being treated) and these patients will be further characterized as number of patients with âtreatment discontinuationâ, âtreatment step downâ or âtreatment switchâ to another category of GINA treatment step-up.
Health care resource use: The number of GP (outpatient) office visits (excluding telephone requests for repeat prescriptions only) and home visits in the year prior to the start of follow-up will be considered and will be compared to those in the one year following treatment step-up.SABA (short acting B2 agonists) use and short course OCS (oral corticosteroid) use: The number of prescriptions of SABA and short course OCS use in the year prior to the start of follow-up will be considered and will be compared to those in the one year following treatment step-up. Use of SABA and OCS will be extracted based on an automated search on the respective BNF codes. Short course OCS use is defined as use of OCS for a consecutive period of less than 30 days.
Description: Technical Summary
Background:
In patients with uncontrolled asthma treated with medium dose ICS/LABA, GINA guidelines recommend to either increase to high dose ICS/LABA or to start triple therapy consisting of medium dose ICS/LABA+LAMA. Although adding LAMA on top of high dose ICS+LABA is not recommended by GINA for this step, it is likely that this regimen is also initiated in the real world.Aims:
To study the main drivers of prescribing any of the three step-up treatment options and to determine patient characteristics that are associated with treatment response to the specific treatment regimens.Outcomes:
Asthma Treatment response is defined as a â¥25% reduction in the annual severe asthma exacerbation rate following treatment step-up compared to the exacerbation rate in the 12 months prior to follow-up and/or improvement of â¥7.5% of FEV1% compared to baseline FEV1% in combination with an absolute improvement of FEV1 compared to baseline of 100 mL.
Severe asthma exacerbation is defined as use of acute systemic corticosteroids, ED visit, and/or hospitalisation for reasons of asthma exacerbation. Hospital Episode Statistics (HES) data will be used to determine hospitalisations due to severe asthma exacerbation.Methods:
We will include patients diagnosed with asthma, aged 18-65 years with at least 1 year of database history. Within this cohort, we will include patients prescribed medium dose ICS+LABA and requiring treatment step-up (high dose ICS+LABA, medium dose ICS+LABA+LAMA or high dose ICS+LABA+LAMA). The study period is from 2010-2020.Descriptive statistics will be used providing numbers, proportions, medians and interquartile range to describe the total number of patients with asthma, patient characteristics in the respective treatment step-up cohorts, discontinuation, and switching patterns. Within each treatment cohort, logistic regression will be run with outcome treatment response. Cluster analysis will be conducted, in each treatment cohort separately using characteristics at index date and response characteristics.
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The effect of treatment intensification for type 2 diabetes on health outcomes in routine care and across highly granular patient subgroups: a regression discontinuity analysis — Till Bärnighausen ...
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The effect of treatment intensification for type 2 diabetes on health outcomes in routine care and across highly granular patient subgroups: a regression discontinuity analysis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-18
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Hrvoje Curis - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Surrey
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
Primary outcomes (all to be measured over time horizons of one year, five years, ten years, and 15 years): HbA1c and BMI levels; number of severe adverse health events (stroke, heart attack, neuropathy, retinopathy, nephropathy, lower limb amputations â each event type evaluated separately); all-cause mortality. Bandwidth of the running variable (HbA1c) around the threshold will be narrow i.e. derived from data so that treatment and control groups, as per RDD design, will be comparable and will differ only by the treatment intervention. We will use the first HbA1c measurement of the patient for the comparison group assignment and future HbA1c measurements (for time horizons as stated above) as the outcome, making HbA1c measurement a sensible outcome.
Secondary outcomes (all to be measured over time horizons of one year, five years, ten years, and 15 years): probability of at least one all-cause emergency hospitalization; number of all-cause hospitalizations; probability of at least one all-cause hospitalization; probability of at least one severe adverse health event.
Description: Technical Summary
Previous studies investigating the health effects of T2DM therapy administered to T2DM patients and corresponding treatment pathways including times and conditions leading to treatment intensification are largely limited to controlled clinical trials. While these studies have shown the efficacy of T2DM therapy intensification in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Non-experimental studies, in contrast, may fail to establish causality due to insufficient control of confounding factors. This study seeks to measure the effect of treatment intensification in T2DM patients on short-, mid-, and long-term clinical outcomes (all-cause mortality, HbA1c levels and other T2DM related outcomes) in a routine care set-up. To establish causality, we make use of a regression discontinuity (RD) design taking advantage of major UK clinical guidelines (NICE) recommending different T2DM treatment pathways based on threshold rules related mainly to patientsâ HbA1c level. Because physicians base their treatment decisions on additional considerations besides clinical guidelines, we use an instrumental variable approach that is robust to partial compliance. We evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with HbA1c levels increasingly close to the treatment threshold level. The findings of this study are expected to provide novel insights into the effectiveness of different T2DM treatment pathways in a real-life setting and can directly inform clinical practice.
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Association between weight loss and fertility in women diagnosed with polycystic ovary syndrome and living with overweight or obesity — Esther Zimmermann ...
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Association between weight loss and fertility in women diagnosed with polycystic ovary syndrome and living with overweight or obesity
Datasets:GP data, HES Outpatient; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-02-16
Organisations:
Esther Zimmermann - Chief Investigator - Novo Nordisk
Esther Zimmermann - Corresponding Applicant - Novo Nordisk
Adam Balen - Collaborator - Leeds Teaching Hospitals NHS Trust
Anette Varbo - Collaborator - Novo Nordisk
Christiane L Haase - Collaborator - Novo Nordisk
Tugce Kalayci Oral - Collaborator - Novo Nordisk
Volker Schnecke - Collaborator - Novo NordiskOutcomes:
The primary outcome is:
⢠Time to pregnancy, using the first report of pregnancy captured in the CPRD Pregnancy Register, regardless of the pregnancy outcome.The secondary outcomes are:
⢠Number of women who became pregnant (counts) from index date (date of PCOS diagnosis) to end of follow-up
⢠Number of women who received Assisted Reproductive Technology (ART*) treatment (counts) from index date to end of follow-up*ART includes in vitro fertilization, intracytoplasmatic sperm injection and intrauterine insemination (IVF/ICSI/IUI/) and donor insemination and egg donation (1)
Description: Technical Summary
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder affecting approximately 10% of reproductive aged women. Many women with PCOS are living with overweight or obesity which also affect their ability to conceive. The evidence supporting increased reproductive function after weight loss in these women is sparse. The aim of this study is to investigate the association between weight loss and time to pregnancy. Secondary outcomes are number of pregnancies and number of Assisted Reproductive Technology (ART) treatments. Using a prospective cohort design, eligible women are aged 18 to 45 years with a diagnosis of PCOS from the Clinical Practice Research Datalink (CPRD) based on either a primary care diagnosis using the Read code classification or an ICD-10 coding from secondary care Hospital Episodes Statistics Outpatient (HES OP). Pregnancy is determined based on the first date of an event in the Pregnancy Register. Number of ART treatments are based on either a primary care diagnosis using the Read code classification or an ICD-10 coding from HES OP. Time to pregnancy will be presented and compared using Cox proportional hazards models adjusting for age, smoking status, socioeconomic status, and ethnicity. The analyses will be done in two steps. First we investigate the association between baseline BMI class (Normal weight: 18.5-24.9 kg/m2, Overweight: 25-29.9 kg/m2, Obesity class I: 30-34.9 kg/m2, Obesity class II: 35-39.9 kg/m2, Obesity class III: â¥40 kg/m2) and baseline BMI as continuous variable, respectively, and time to pregnancy. If we find an association between increased baseline BMI and time to pregnancy we will proceed with step two which is the association between percentage weight loss and time to pregnancy. To utilise all the BMI measurements available during follow-up, BMI will be included in the Cox model as a time-varying covariate. The secondary outcomes will be descriptively presented.
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ID 103: De-identified Data Access Extension Request: To evaluate the effectiveness of the Integrated Business Case intervention in Hillingdon in reducing hospital admissions and improving clinical outcomes in patients with chronic conditions — Brunel University London...
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ID 103: De-identified Data Access Extension Request: To evaluate the effectiveness of the Integrated Business Case intervention in Hillingdon in reducing hospital admissions and improving clinical outcomes in patients with chronic conditions
Legal basis:Health Policy
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-21
Opt Outs: no information provided./p>
Organisations: Brunel University London
Description: Hillingdon.
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ID-106: Borough Public Health Profiles and JSNA information — Westminster and Kensington and Chelsea Local Authorities...
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ID-106: Borough Public Health Profiles and JSNA information
Legal basis:Local Authority Support to NHS delivery and Population
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-21
Opt Outs: no information provided./p>
Organisations: Westminster and Kensington and Chelsea Local Authorities
Description: Westminster and Kensington and Chelsea.
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ID-107: to extract a summary of the GP registered borough populations — Westminster and Kensington and Chelsea Local Authorities...
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ID-107: to extract a summary of the GP registered borough populations
Legal basis:Reconciliation of Local Authority and Borough
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-21
Opt Outs: no information provided./p>
Organisations: Westminster and Kensington and Chelsea Local Authorities
Description: Westminster and Kensington and Chelsea.
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ID-105: Extension Request: To make the clinical and financial case for an ICS CVD programme that improves the management and prevention of CVD in NW — Imperial College Health Partners...
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ID-105: Extension Request: To make the clinical and financial case for an ICS CVD programme that improves the management and prevention of CVD in NW
Legal basis:missing
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Cardiovascular Disease in North West London.
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ID-108: Pressure Ulcers Project — Imperial College Health Partners...
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ID-108: Pressure Ulcers Project
Legal basis:Real-world evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-21
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Pressure ulcer.
Source
2021 - 01
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Demographic (Identifiable) (Secondary Uses) — NHS England/Improvement...
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To provide an up to date measure of the number of staff who have received the vaccination. This will assist in future planning of the vaccine roll out. — IG-01921
Recipient Data Controller Organisation(s) : NHS England/Improvement
Approval Date: 28/01/2021
Purpose for which the data is being used: To provide an up to date measure of the number of staff who have received the vaccination. This will assist in future planning of the vaccine roll out.
Dataset: Demographic
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Demographics - NHS Number (Identifiable) (Direct Care ) — NHS England / Improvement...
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To enable NHS England to send a vaccination invite letter to those individuals who have been identified as eligible for an immediate COVID-19 vaccination because they are carers. — IG-01889_2
Recipient Data Controller Organisation(s) : NHS England / Improvement
Approval Date: 03/01/2021
Purpose for which the data is being used: To enable NHS England to send a vaccination invite letter to those individuals who have been identified as eligible for an immediate COVID-19 vaccination because they are carers.
Dataset: Demographics - NHS Number
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: Legal Obligation â Direction to disseminate in COVID-19 Direction
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: Legal Obligation â Direction to disseminate in COVID-19 Direction
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Direct Care.
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dm+d Data Quality Reports (Aggregate (small numbers not supressed)) (Secondary Uses) — NHS Hospital Trusts...
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To provide trusts with data quality reports to help them improve the quality of thier NHS Dictionary of Medicines and Devices (dm+d) coded data submissions. — IG-00305_4
Recipient Data Controller Organisation(s) : NHS Hospital Trusts
Approval Date: 18/01/2021
Purpose for which the data is being used: To provide trusts with data quality reports to help them improve the quality of thier NHS Dictionary of Medicines and Devices (dm+d) coded data submissions.
Dataset: dm+d Data Quality Reports
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data.
Source -
Covid-19 Testing Results (Aggregate (small numbers not supressed)) (Secondary Uses) — Universities in Scotland...
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For the purposes of delivering COVID related public health decision making. — IG-00637_6
Recipient Data Controller Organisation(s) : Universities in Scotland, Wales and Northern Ireland
Approval Date: 31/01/2021
Purpose for which the data is being used: For the purposes of delivering COVID related public health decision making.
Dataset: Covid-19 Testing Results
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Trends and factors associated with prescription opioid utilisation, dependence and deaths in patients with rheumatic and musculoskeletal diseases — Meghna Jani ...
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Trends and factors associated with prescription opioid utilisation, dependence and deaths in patients with rheumatic and musculoskeletal diseases
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-06
Organisations:
Meghna Jani - Chief Investigator - University of Manchester
Meghna Jani - Corresponding Applicant - University of Manchester
Belay Yimer - Collaborator - University of Manchester
DAVID JENKINS - Collaborator - University of Manchester
Jose Benitez-Aurioles - Collaborator - University of Manchester
Joyce (Yun-Ting) Huang - Collaborator - University of Manchester
Lotta Castren - Collaborator - University of Manchester
Lucy Bull - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of Manchester
Niels Peek - Collaborator - University of Manchester
Ramiro Bravo - Collaborator - University of Manchester
Ruth Costello - Collaborator - University of Manchester
William Dixon - Collaborator - University of ManchesterOutcomes:
Opioid prescriptions per year; Opioid-related hospitalisations; opioid dependence; cause specific and all cause mortality
Description: Technical Summary
Rising opioid use has been associated with an alarming rise in opioid-related harms, dependence and mortality in North America. However, fewer data are available in Europe. RMDs are one of the most common indications for prescribing opioids. These patients may already be at high-risk of opioid-related morbidity/mortality due to multimorbidity, immunosuppression and polypharmacy.
Aims: In new opioid users with the following RMDs: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, osteoarthritis and fibromyalgia to:
(i) Characterise national UK opioid prescribing trends between 2006-2021
(ii) Evaluate trends in hospital admissions associated with opioid-related prescriptions, dependence and mortality
(iii) Identify individual, prescribing, demographic and contextual risk factors that predispose to opioid-dependence and mortality
(iv) Predict opioid-related mortality risk to enable a stratified approach to prescribing in clinical care
Methods: A retrospective observational study will be performed using 2006-2021 data using linked CPRD data. A combination of traditional (e.g. survival analysis/multi-state models) and machine learning methods will be used to address the outlined objectives.
Expected outputs: Prediction of individual risk of opioid-related harms would allow future development of targeted interventions, guiding clinicians towards more careful prescribing in those at high-risk while avoiding depriving the entire population of this class of analgesics.
Source -
Impact of COVID-19 pandemic on routine clinical management of patients with neurological diseases: a descriptive retrospective cohort study — Teresa Karrer ...
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Impact of COVID-19 pandemic on routine clinical management of patients with neurological diseases: a descriptive retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-13
Organisations:
Teresa Karrer - Chief Investigator - F. Hoffmann - La Roche Ltd
Teresa Karrer - Corresponding Applicant - F. Hoffmann - La Roche Ltd
Isaac Gravestock - Collaborator - Roche
Julie MOUCHET - Collaborator - Roche
Loes Rutten-Jacobs - Collaborator - Roche
Paul Dillon - Collaborator - F. Hoffmann - La Roche LtdOutcomes:
Separately for each year 2015-2020 in Autism Spectrum Disorder (ASD), Multiple Sclerosis (MS), Parkinsonâs Disease (PD) and Alzheimerâs disease (AD) patients: Incidence of respective neurological disease; Number and type of medical consultations; Number of referrals and type of speciality; Number of prescriptions and drug class including antidepressants and anxiolytics
Description: Technical Summary
The COVID-19 pandemic may have profoundly changed the clinical management of patients with chronic conditions. A recent survey of patients with chronic conditions across Europe and the US (N= 6780) reported that 41% of patients had less medical visits than usual, 46% had postponed or cancelled medical visits or surgeries and 10% had a treatment modification [1]. For future real-world data studies in neurological disease populations, it is important to confirm and quantify the evidence - which was mostly collected in surveys - in real-world data to better understand how the COVID-19 pandemic impacts the routine clinical management of different types of neurological diseases. This retrospective cohort study of prevalent and incident patients with selected neurological disorders (i.e., Autism Spectrum Disorder, Multiple Sclerosis, Parkinsonâs Disease and Alzheimerâs disease) aims at describing the impact of the COVID-19 pandemic on primary care data in England. For this purpose, we compare healthcare resource utilisation during the COVID-19 pandemic peak period in 2020 to the same periods in 2015-2019 using CPRD. Specifically, we quantify the incidence of the selected neurological diseases, proportion and average number of medical consultations, referrals, and prescriptions including antidepressants and anxiolytics. Additionally, we explore the relation of these outcomes to the daily COVID-19 case numbers and the timing of the UK governmental measures to prevent the spread of SARS-CoV-2 using interrupted time series analysis. The findings contribute to our understanding how the COVID-19 pandemic impacted primary care management in England. This can inform future studies generating real-world evidence based on this real-world data source. Moreover, our results could generate hypotheses on the impact of different COVID-19 policies on routine clinical care.
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Investigating epilepsy-related mortality among children and young people with intellectual disabilities and co-occurring epilepsy: a record linkage cohort study — Gillian Smith ...
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Investigating epilepsy-related mortality among children and young people with intellectual disabilities and co-occurring epilepsy: a record linkage cohort study
Datasets:GP data, ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-26
Organisations:
Gillian Smith - Chief Investigator - University of Glasgow
Gillian Smith - Corresponding Applicant - University of Glasgow
Bhautesh Jani - Collaborator - University of Glasgow
Craig Meville - Collaborator - University of Glasgow
Iain Carey - Collaborator - St George's, University of London
Jill Pell - Collaborator - University of Glasgow
Michael Fleming - Collaborator - University of Glasgow
Sarita Soni - Collaborator - University of GlasgowOutcomes:
Primary outcomes:
The primary outcomes will be:
⢠The proportion of deaths occurring in those with epilepsy which occur in those with co-occurring intellectual disabilities
⢠The proportion of deaths which are epilepsy-related and non-epilepsy-related in children who have epilepsy with and without co-occurring intellectual disabilities
⢠The proportion of deaths which are avoidable using the Office of National Statistics UK definition for children and young people
⢠All-cause and cause-specific hazard ratios including for avoidable deathsSecondary outcomes:
The secondary outcome will be:
⢠Proportion of deaths which are related to life-limiting conditions (LLC)Description: Technical Summary
Children and young people with intellectual disabilities have a standardised mortality ratio of 11.6. Epilepsy is among the most common contributing causes of death in children and young people with intellectual disabilities. Available evidence suggests that around 90% of epilepsy deaths occurs in children and young people who have co-existing intellectual disabilities. However, the quality of the studies reporting this high proportion of overall deaths in children and young people with epilepsy lacks rigour to inform policy and service developments. This study will use systematic methods to identify a large cohort of children and young people with epilepsy and a large cohort of children and young people with intellectual disabilities. A representative control group of children and young people in the general population will also be included.
We will use CPRD primary care data between 2006 up to 2018. Linkage of the cohorts to the Office of National Statistics Death registration up to 2018 will be used to compare the proportion of deaths of children with epilepsy that are among children with intellectual disabilities, the proportion of deaths that are caused by epilepsy, as well as to compare the differences in the mortality rates and causes of death. Three study groups will be defined to answer these research questions:
Study groups:
1. Population aged 0-24 with intellectual disabilities2. Population aged 0-24 with epilepsy:
a) epilepsy and co-existing intellectual disabilities
b) epilepsy without intellectual disabilities3. Representative sample of the general population aged 0-24, with a sampling frame of 7:1 to study group 1
Descriptive data will be analysed using t-tests, Mann-Whitney and Χ2 tests. Cox proportional hazards models will be used to analyse whether there are significant risk differences in all-cause mortality, epilepsy-related mortality and avoidable mortality between the three study groups.
Source -
Incidence and prevalence of heart failure in patients with idiopathic pulmonary fibrosis (IPF) between 2010 - 2019 and the impact of heart failure treatment on IPF mortality: a population-based study using CPRD Aurum — Jennifer Quint ...
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Incidence and prevalence of heart failure in patients with idiopathic pulmonary fibrosis (IPF) between 2010 - 2019 and the impact of heart failure treatment on IPF mortality: a population-based study using CPRD Aurum
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-27
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ardita Koteci - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Hannah Whittaker - Collaborator - Imperial College London
Laura Portas - Collaborator - Imperial College London
Peter George - Collaborator - Royal Brompton HospitalOutcomes:
Incidence of left-sided heart Failure (HF) in IPF patients, stratified by age, gender and calendar year; Prevalence of left-sided heart failure in IPF patients, stratified by age, gender and calendar year; Crude and adjusted hazard ratios of the risk between incident (< 6months) and prevalent (> 6 months) use of each of the following heart failure treatments: angiotensin receptor blockers (ARBs), angiotensin converting enzyme inhibitors (ACEi), beta-blockers, loop diuretics and mineralocorticoid receptor antagonists (MRA), on all-cause, IPF-specific and cardiovascular mortality between 2010 â 2019
Description: Technical Summary
Idiopathic pulmonary fibrosis (IPF) is a progressive lung condition of unknown aetiology, resulting in irreversible lung scarring. Multimorbidity is common in IPF and a risk factor for reduced survival. In particular, cardiovascular diseases are the most prevalent comorbidity and significant risk factors for increased mortality.
Nevertheless, while data are available on ischaemic heart disease and pulmonary hypertension with associated right-heart failure, no data are available on the incidence or prevalence of left-sided heart failure within this patient population, nor are there any data on the impact of heart failure treatments on IPF survival.
Therefore, we aim to conduct a retrospective cohort study using CPRD Aurum data to assess trends in incidence and prevalence of left-sided heart failure in IPF patients and the impact of heart failure treatments on IPF mortality over a 10-year period between 2010 â 2019. The study population will include adults aged >40 years with a SNOMED-CT code denoting an IPF diagnosis, with 12 monthsâ worth of registration data prior to cohort entry and a HES and ONS-linked record. Baseline demographics, cardiovascular risk factors and cardiovascular medication use will be described. Heart failure prevalence and incidence in the cohort will be calculated, with heart failure identified by presence of a code denoting a heart failure diagnosis and validated algorithms to differentiate between heart failure with preserved or reduced ejection fraction. Calculated heart failure prevalence and incidence from this IPF cohort will be compared to published estimates in the general population and COPD cohorts. Subsequently, using ONS-linked data, a multivariate Cox proportional hazards regression model will be fitted using stepwise selection to determine adjusted hazard ratios for the risk of incident (<6 months) or prevalent (>6 months) use of the following heart failure treatments - ARBs, ACEi, beta-blockers, loop diuretics and MRAs -on all-cause, IPF-specific and cardiovascular mortality.
Source -
Cohort study of risk factors of acute and chronic cardiovascular events in COVID-19 patients — Martin Gulliford ...
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Cohort study of risk factors of acute and chronic cardiovascular events in COVID-19 patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-21
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Emma Rezel-Potts - Corresponding Applicant - King's College London (KCL)Outcomes:
Primary analysis:
- Hospital admission.
- Mortality.
- Diabetes.
- Cardiovascular disease diagnoses.
Outcomes will be evaluated over the duration of the study period.Secondary analysis
Chronic cardiovascular conditions following index dates among those surviving, measured according to prescriptions for:
- diuretics
- anticoagulants
- aspirin
- antihypertensive drugs
- antiplatelet drugs
- lipid lowering drugs (mainly statins).Description: Technical Summary
Cardiovascular risk factors and heart conditions have been associated with increased risk of poor COVID-19 outcomes. Several hospitalised COVID-19 patients have developed cardiovascular outcomes including acute heart failure, chronic heart failure, pulmonary edema and myocardial infarction. Pre-existing cardiovascular disease seems to be an important driver of COVID-19 severity, however other studies have noted serious cardiovascular outcomes in COVID-19 patients without a history of cardiovascular disease. SARS-CoV-2 could directly induce myocardial damage, potentially via the proinflammatory cytokine storm. We seek to improve evidence in this area for earlier identification of COVID-19 patients at high risk of cardiovascular outcomes who could benefit from dedicated cardiac monitoring and early referral to specialist teams. We will use the Clinical Practice Research Datalink (CPRD) Aurum and GOLD datasets to conduct a population cohort study, evaluating outcomes among patients with a COVID-19 diagnosis compared to a matched cohort without a COVID-19 diagnosis. Outcomes will be hospital readmission, mortality, diabetes events and cardiovascular events following COVID-19 diagnosis. Cox proportional hazards regression models will use hazards ratios to compare outcomes to a cohort of patients matched to the COVID-19 patients on practice, gender and year of birth and no COVID-19 diagnosis during the study period. Matched analyses will be adjusted for covariates including ethnicity; risk profiles between groups will be compared. Cardiovascular disease risk factors will be compiled including smoking status, blood pressure, cholesterol, diabetes and body mass index. Hospital admissions and cardiovascular events will be identified using the Hospital Episode Statistics Admitted Patient Care registry. We will use the Office for National Statistics (ONS) Death Registration Data for mortality data if possible, but note that the latest release (set 20) only covers up to June 2020. Should there be no further release prior to initiating our analysis, we will use the CPRD Aurum and GOLD death dates instead. A secondary analysis will evaluate longer-term cardiovascular effects of COVID-19 using CPRD data on relevant prescriptions including diuretics and anticoagulants.
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The impact of timely diagnosis and recurrent health seeking behaviour on the subsequent clinical course of Inflammatory Bowel Disease: A UK population based study — Sonia Saxena ...
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The impact of timely diagnosis and recurrent health seeking behaviour on the subsequent clinical course of Inflammatory Bowel Disease: A UK population based study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-08
Organisations:
Sonia Saxena - Chief Investigator - Imperial College London
Nishani Jayasooriya - Corresponding Applicant - St George's, University of London
Alex Bottle - Collaborator - Imperial College LondonOutcomes:
SECTION C
Primary outcome measures
The impact of time to diagnosis and recurrent health seeking behaviour on the clinical course of IBD (described in section K and M) will be explored by examining the following outcome measures.
1. Medical intervention
(a) Steroid dependence: We will identify IBD patients who received prolonged courses of oral corticosteroids therapy. We have defined steroid dependence as either; i) the inability to stop steroids within 3 months after the initiation of treatment or ii) in cases where steroid treatment is re-instituted within 3 months of stopping a previous course. These definitions are in keeping with the European ECCO definition of steroid-dependency. [10] Early steroid use (within 90 days of diagnosis) - this has been shown to be an independent marker for severity with an increased need for earlier surgery in both UC and CD. [11,12] This proxy marker for disease severity has also been used in previous CPRD work on IBD outcomes. [13,14]
I. We will evaluate and compare rates of steroid dependency between the defined exposure groups
(b) Immunomodulator therapy initiation
I. We will evaluate and compare rates of immunomodulator therapy initiation between the defined exposure groups
We will use thiopurine (inclusive of immunomodulator therapy) exposure as a proxy marker for disease severity. In UC, exposure to thiopurines within 3 years of diagnosis is associated with increase in colectomy risk. [15] Similar patterns have been seen in CD. [16] Patients will be subdivided into either exposed or non-exposed for this variable, dependent on whether they have a prescription for these medication in the period of follow up.(c ) Biological therapy initiation
I. We will evaluate and compare rates of biologics therapy initiation between the defined exposure groups
We will also use biologic exposure as a proxy marker for disease severity. Patients will be subdivided into either exposed or non-exposed for this variable, dependent on whether they have a prescription for these medication in the period of follow up.
2. IBD related Hospital admission
I. Using HES linked data we will calculate hospital admission rates following diagnosis. We will further subcategorise admissions into those which were elective or emergency.
3. Surgical intervention
I. We will calculate rates of surgical intervention for IBD. CD surgery will be subcategorised as either major (intestinal) abdominal surgery or perianal surgery. Colectomy surgical procedures will be explored for UC
Description: Technical Summary
Timely diagnosis in inflammatory bowel disease (IBD) is essential to enable early treatment to alleviate symptoms and prevent disease progression. The impact of time interval from first health seeking behaviour to the point of IBD diagnosis on disease outcome in IBD is unclear. Some studies demonstrate a correlation between this time period and increased risk of intestinal surgery in Crohnâs disease (CD), others did not. The influences of this time period on the course ulcerative colitis (UC) are limited. The impact of this time period on the subsequent clinical course of IBD has not been examined on a population level in the United Kingdom. Furthermore what is less clear is the impact of recurrent health seeking behaviour with undiagnosed gastrointestinal symptoms on the subsequent clinical course of IBD.
The study proposed is to examine the impact of time to diagnosis, defined as the time from first health seeking behaviour for unexplained gastrointestinal symptoms to IBD diagnosis date, on the subsequent clinical course of IBD. Our outcome measures are time to; first steroid use, steroid dependency, immunomodulator initiation, biologics initiation, hospital admission and surgical intervention. Analysis will be separate for CD and UC. We will also evaluate the impact of recurrent consultations with GI symptoms on the clinical course of IBD.
We will identify index presentation to primary care with gastrointestinal symptoms in the three years prior to IBD diagnosis date. We will analyse timeâdependent survival outcomes using the KaplanâMeier method and generate survival curves to estimate the cumulative probability of the primary outcomes by each exposure group (a) time to diagnosis and (b) recurrent consultations for gastrointestinal symptoms. The logârank test will be used to compare outcomes. We will use a Cox proportional hazard model to calculate hazards ratio for our primary outcomes.
Source - and 26 more projects — click to show
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Trends of gabapentinoid prescribing associated overdose and mortality in chronic pain patients and the impact of gabapentinoid classification as a controlled drug — Roger Knaggs ...
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Trends of gabapentinoid prescribing associated overdose and mortality in chronic pain patients and the impact of gabapentinoid classification as a controlled drug
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-21
Organisations:
Roger Knaggs - Chief Investigator - University of Nottingham
Joud Alfriah - Corresponding Applicant - University of Nottingham
John Williams - Collaborator - University of Nottingham
Sonia Gran - Collaborator - University of NottinghamOutcomes:
1. Prescribing trends, annual rates (incidence and prevalence) of gabapentinoid users for chronic pain (gabapentinoid users/ 10,000 registrants).
2. Gabapentinoid doses pattern for chronic non-cancer pain patients expressed by annual prescribed daily dose (PDD) per user per day and annual supply days.
3. The impact of gabapentinoid classification on drug utilisation (monthly prescribing trends and monthly gabapentinoid PDD per user per day).
4. The association between gabapentinoid prescribing (treatment) and the risk of overdose expressed as unadjusted and adjusted hazard ratios with corresponding 95% CIs.
5. The association between gabapentinoid prescribing (treatment) and related mortality expressed as unadjusted and adjusted hazard ratios with corresponding 95% CIs
Description: Technical Summary
In the UK, gabapentin was licensed as an adjunct antiepileptic therapy for partial seizures and treating focal seizures in 1993. In 2000, gabapentin gained its approval as an analgesic for managing neuropathic pain and postherpetic neuralgia. Pregabalin was licensed in 2004 for treating neuropathy, postherpetic neuralgia, as an add-on drug to treat resistant partial epilepsy and generalised anxiety disorder.
A dramatic increase in the number of gabapentinoid (gabapentin and pregabalin) prescriptions has been reported between 2013 and 2017. Despite their limited efficacy for unlicensed pain indications, gabapentinoids are widely used off-label; up to 90% of prescriptions for pregabalin and 83% for gabapentin.
Both pregabalin and gabapentin have been reported as having the potential for misuse, which is increased with concomitant use of other substances, including opioids, alcohol, antidepressants, and psychostimulants. Gabapentinoid misuse could lead to medical consequences such as increase in emergency department visits and overdose deaths. Therefore, the UK government has recently classified these drugs as class C schedule 3 controlled substances in April 2019 after increasing off-label use, misuse and deaths.
We will conduct a drug utilisation study using CPRD data between January 1, 2005, and December 31, 2020. We will evaluate the impact of classification on prescribing trends; patterns of doses for pain conditions using Interrupted time series analysis. We will also investigate the association between the gabapentinoid prescribing and drug-related deaths and overdose. Our results will provide insight and impact of classification as to how gabapentinoids are prescribed for chronic pain in UK primary care. Moreover, it will highlight the potential risk of overdose and the related death associated with these medicines.
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PRECISION-Predicting Risk of Endometrial Cancer in aSymptomatIc wOmeN — Sarah Kitson ...
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PRECISION-Predicting Risk of Endometrial Cancer in aSymptomatIc wOmeN
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-15
Organisations:
Sarah Kitson - Chief Investigator - University of Manchester
Sarah Kitson - Corresponding Applicant - University of Manchester
Artitaya Lophatananon - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Emma Crosbie - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Glen Martin - Collaborator - University of Manchester
Helena O'Flynn - Collaborator - University of ManchesterOutcomes:
Endometrial cancer diagnosis; endometrial cancer histological sub-type
Description: Technical Summary
This project aims to develop an accurate endometrial cancer risk prediction model to be used in primary care and to identify potential prevention strategies for investigation in future clinical trials. We aim to use the CPRD to externally validate our flexible parametric survival model that we will develop separately, which utilises age, body mass, reproductive and family history and measures of insulin resistance to quantify an individual womanâs endometrial cancer risk. The CPRD has been specifically chosen for model validation as it contains data on a patient cohort representative of the general population. The dataset will be restricted to female patients aged 45-60 years registered with either a CPRD Gold or Aurum practice between 1/1/2000 and 31/12/2016 and eligible for linkage to HES APC, NCRAS and ONS mortality records. HES data will be used to determine diagnoses and operations and combined with cancer registry data to ascertain endometrial cancer cases. Validation of the model will be performed by applying the prediction model (exactly as derived) to women with an intact uterus, with calibration quantified through flexible calibration plots (plotting the observed number of events against predicted risks for groups across the risk prediction spectrum) and estimation of calibration intercept and slope. The ability of the model to discriminate at baseline between individuals who do and do not go on to develop endometrial cancer will be assessed using the concordance (c) statistic. Should the model perform poorly at external validation, the coefficients will be updated using data from new individuals within the CPRD.
A multivariable logistic regression model, adjusting for age, body mass and other important risk factors, will be used to estimate the efficacy of potential prevention strategies. These include those interventions identified in our systematic review; namely, the Mirena intrauterine system, metformin, aspirin and weight loss.
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Use of renin-angiotensin-aldosterone system inhibitors and the risk of acute pancreatitis — Samy Suissa ...
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Use of renin-angiotensin-aldosterone system inhibitors and the risk of acute pancreatitis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-19
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Alan Barkun - Collaborator - McGill University
Emily McDonald - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Julie Rouette - Collaborator - McGill UniversityOutcomes:
We will identify all incident hospitalizations for acute pancreatitis events recorded in the HES database (ICD-10 codes: K85.0-K85.3, K85.8, K85.9 in primary position).
Description: Technical Summary
Renin-angiotensin-aldosterone system inhibitors are antihypertensive drugs that include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). While these drugs have clinical benefits, there is conflicting evidence on their effects on acute pancreatitis. On the one hand, some observational studies have associated the use of ACE inhibitors with an increased risk of acute pancreatitis, while others have associated the use of ARBs with a decreased risk of this outcome. Given that acute pancreatitis can be a serious and life-threatening condition, additional studies are needed to investigate the role of ACE inhibitors and ARBs on the incidence of acute pancreatitis. Using the Clinical Practice Research Datalink, the Hospital Episodes Statistics Repository, and the Office for National Statistics, we will address this question by comparing new users of ACE inhibitors and ARBs (separately) with new users of dihydropyridine calcium channel blockers between April 1, 1998 to December 31, 2018, with follow-up until March 31, 2019. Calendar time-specific propensity scores will be estimated and, using standardized mortality ratio weighting, weighted Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals for acute pancreatitis comparing 1) use of ACE inhibitors with use of dihydropyridine calcium channel blockers and 2) use of ARBs with use of dihydropyridine calcium channel blockers, with calendar year as stratification variable. The results from this study will provide much-needed information on the safety of ACE inhibitors and ARBs on the incidence of acute pancreatitis
Source -
The descriptive epidemiology of Adverse Events of Special Interest for COVID-19 and other vaccines in the general population and after seasonal influenza and COVID-19 disease — Daniel Prieto...
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The descriptive epidemiology of Adverse Events of Special Interest for COVID-19 and other vaccines in the general population and after seasonal influenza and COVID-19 disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-19
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Xintong Li - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Danielle Robinson - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University Hospitals
Xintong Li - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRDOutcomes:
1.Neurologic/ neuropsychiatric (Guillain Barré Syndrome (GBS), Miller Fisher syndrome, Encephalomyelitis (include Acute disseminated encephalomyelitis (ADEM)), Meningitis, Encephalitis, Aseptic meningitis, Encephalitis / Encephalomyelitis, Meningoencephalitis, Anosmia, ageusia, Generalized convulsion, Transverse myelitis, Narcolepsy, Bellâs palsy, Other Cranial nerve disorders (other than VII)); 2.Immunologic (Acute aseptic arthritis, Anaphylaxis, Vasculitis, Arthritis, Type I Diabetes); 3. Hematologic (Thrombocytopenia, Thrombotic thrombocytopenia purpura, Idiopathic thrombocytopenic purpura (ITP), Coagulation disorder: Deep vein thrombosis , Pulmonary embolus , Cerebrovascular stroke, Limb ischemia, Hemorrhagic disease); 4.Cardiovascular system (Acute cardiac injury :Microangiopathy, Heart failure and cardiogenic shock, Stress cardiomyopathy, Coronary artery disease, Arrhythmia, Myocarditis, pericarditis, Ischemic stroke, intracerebral haemorrhage, Cerebral venous sinus thrombosis and related disorders, Intracranial venous thrombosis and related disorders, CNS vasculitis (ANCA-associated vasculitis, Takayasu Arteritis and Giant Cell Arteritis)); 5.Respiratory system (Acute respiratory distress syndrome, spontaneous pneumothorax); 6.Dermatologic (Single organ cutaneous vasculitis, Erythema multiforme, Chilblain-like lesions); and 7.Others (Rhabdomyolysis).
Description: Technical Summary
The global pandemic of COVID-19 has resulted in over 50 million reported cases and over 1.2 million deaths globally. Meanwhile, hundreds of vaccines are in clinical evaluation and some show clinical efficacy. While planning for the large-scale immunization program, it is important to understand the potential adverse events after vaccination or viral infections. Electronic health records, including CPRD, have been increasingly used in safety studies. The ability to and the reliability of capturing the adverse events using suitable phenotyping algorithms in such databases are the foundation in conducting these studies. We will firstly identify the phenotyping algorithms of the AESI used in other studies, or develop the phenotypes if no existing one is found. Then we will evaluate the performance of these phenotypes using the diagnostic and evaluation tool that had been previously developed. The second objective is to estimate the background incidence rates (IR) of the AESI among the general population from the year 2006 to 2019. Individuals who were observed for at least 365 days during the study period will be included. The numerator of the incidence rate will be the total number of incident cases in each year, and the denominator will be person-time at risk each year. We will also estimate the IR among patients who were diagnosed or received a positive test for COVID-19 (after 31-Jan-2020) or seasonal influenza. We will apply different algorithms in identifying both the exposures and the outcomes. A tested negative cohort will be identified using primary care data as a negative control group as well. We will then carry on a self-controlled case series analysis to exam the association between developing the AESI and COVID-19 or influenza infections using the conditional Poisson regression model. A set of sensitivity analyses will be conducted to test the assumptions of this method.
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Understanding associations between cardiometabolic and cardiac health, and risk of dementia — Donald Lyall ...
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Understanding associations between cardiometabolic and cardiac health, and risk of dementia
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-28
Organisations:
Donald Lyall - Chief Investigator - University of Glasgow
Donald Lyall - Corresponding Applicant - University of Glasgow
Bhautesh Jani - Collaborator - University of Glasgow
Claire Hastie - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
Frederick Ho - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Jim Lewsey - Collaborator - University of Glasgow
Kathryn Richardson - Collaborator - University of East Anglia
Naveed Sattar - Collaborator - University of Glasgow
Terence Quinn - Collaborator - University of GlasgowOutcomes:
⢠Exposure: frequencies of cardiometabolic (e.g. hypertension; type-2 diabetes; high cholesterol) and/or cardiac (e.g. atrial fibrillation; heart failure) conditions (see appendix for full list).
⢠Outcome: dementia, categorised/derived into:
o Late-onset Alzheimerâs disease [AD; index age â¥65 years]
o Vascular dementia (any age)
o All-cause dementia(excluding read codes pertaining to familial early-onset AD).Diagnosis/indexing of dementia will be defined as the presence in the patientâs record of any CPRD read codes for dementia as a diagnosis, symptom, or referral, or prescription for a cognitive-type medication (memantine, donepezil, rivastigmine, galantamine, or tacrine) if a code for a diagnosis of dementia was recorded within 12 months (where index date will be considered date of that prescription).
Description: Technical Summary
Dementia is a public health priority. It is a condition with no current ameliorative treatments and the focus is therefore prevention and delaying onset. Cardiometabolic conditions such as diabetes, hypertension and high cholesterol, as well as cardiac conditions such as heart failure and atrial fibrillation, are generally known independent risk factors. This is probably due to a variety of mechanisms including but not limited to atherosclerosis limiting blood flow to the brain; increased promotion/decreased clearance of characteristic Alzheimerâs disease amyloid beta plaques; increased neuroinflammation and âleakageâ of the blood-brain barrier (i.e. microhaemorrhages). There is also likely some confounding where shared risk factors underlie both physical and cognitive health.
The aim of the proposed study is to test for associations between cardiometabolic and/or cardiac health and risk of dementia; the extent to which these associations are statistically independent of other risk factors such as smoking, obesity, deprivation, medications and mental health conditions, and whether people with both cardiometabolic and cardiac conditions (vs. one alone) show synergistically vs. additively increased risk. For this population-based study, we will use primary care records, derived from general practice information systems, linked anonymously with secondary care data from Hospital Episode Statistics Admitted Patient Care data. We plan to use the linkage of these data provided by the Clinical Practice Research Datalink (CPRD) Gold and Aurum datasets.
This research will include nested case-control study of the prevalence of dementia (defined a priori by read-codes) in patients with and without cardiometabolic and cardiac conditions, investigating the relationship between baseline conditions, potential confounders (e.g. medications; mental health; deprivation) and dementias. We will use linear and conditional logistic regressions to these for these associations and interactions, similar to prior independent CPRD/dementia studies.
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A machine learning approach to classify types of headache from laboratory blood test results — Fei Yang ...
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A machine learning approach to classify types of headache from laboratory blood test results
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-29
Organisations:
Fei Yang - Chief Investigator - Roche
Fei Yang - Corresponding Applicant - Roche
Benjamin Torben-Nielsen - Collaborator - F. Hoffmann - La Roche Ltd
Carsten Magnus - Collaborator - F. Hoffmann - La Roche Ltd
Chuang Liu - Collaborator - F. Hoffmann - La Roche Ltd
Emilie Dejean - Collaborator - Celgene Corporation
Iori Namekawa - Collaborator - Roche
Marie Stobbe - Collaborator - F. Hoffmann - La Roche Ltd
Simon Davidson - Collaborator - F. Hoffmann - La Roche Ltd
Tong Meng - Collaborator - Roche Molecular Systems, IncOutcomes:
Primary causes of headaches including diagnoses of migraine, tension-type headache and cluster headache; Secondary causes of headaches including diagnoses of ischemic stroke, cerebral venous thrombosis, hemorrhage, arteritis, and angiitis.
Only patients presented with a headache symptom and received a specific diagnosis as mentioned above that can classify the headache as either primary or secondary will be included (please also see following sections - "Definition of the Study population" and "operational definition of outcomes" for details). Patients with headache as a symptom caused by other reasons, e.g. having a cold, drinking too much alcohol or dehydration will not be included in this study. Potential bias will be considered and described in the section - "Limitations of the study design, data sources, and analytic methods".
Description: Technical Summary
This is a retrospective cross-sectional study using secondary data from the CPRD GOLD and CPRD Aurum databases in the UK. The study aims to develop a machine-learning (ML) approach based on laboratory blood test results to aid in classification of primary and secondary headaches for patients presented with headache symptoms at primary care encounters.
The proposed study will include patients who visited general practitioner (GP) practices in the UK for a complaint of headache symptom, received a specific diagnosis that can classify the headache as either primary or secondary headache and had laboratory blood test results recorded within a one-month time period in the CPRD system after the first GP visit.
In this study, the primary headaches will be classified according to diagnoses of migraine, tension-type headache and cluster headache. The secondary headaches will be classified according to diagnoses of ischemic stroke, cerebral venous thrombosis, hemorrhage, arteritis, and angiitis.
We will first describe patientsâ demographic and clinical characteristics including laboratory blood test results) for the whole study population and for primary and secondary headache groups separately.
Then, to build a predictive model that helps classify two types of headache, we will examine two supervised ML algorithms, namely logistic regression and random forest. The parameters selected for the predictive model will include laboratory blood test results (counts of red blood cell, platelet, white blood cell, neutrophil, lymphocyte, monocyte, eosinophil and basophil, mean corpuscular volume, and hemoglobin) and ratios of these parameters. The performance of the predictive model between two algorithms will be evaluated by standard classification metrics including confusion matrix, accuracy, balanced accuracy, average precision score, F1-score and area under the curve.
It should be noted that the final predictive model will not be suitable for all patients with headache as those without a specific diagnosis will not be included.
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Lifelong Adverse health ouTcomes Especially dementia risk following Traumatic Brain Injury (LATE-TBI) — William Stewart ...
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Lifelong Adverse health ouTcomes Especially dementia risk following Traumatic Brain Injury (LATE-TBI)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-15
Organisations:
William Stewart - Chief Investigator - University of Glasgow
Donald Lyall - Corresponding Applicant - University of Glasgow
Bhautesh Jani - Collaborator - University of Glasgow
Claire Hastie - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
Emma Russell - Collaborator - University of Glasgow
Frederick Ho - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Jim Lewsey - Collaborator - University of Glasgow
Michael Fleming - Collaborator - University of Glasgow
Robert Pearsall - Collaborator - LANARKSHIREOutcomes:
⢠History of traumatic brain injury
⢠Primary and secondary causes of death, specifically deaths from the most common causes in the community (diseases of the circulatory system; diseases of the respiratory system; cancer; neurodegenerative disease) or where cause of death is recorded as suicide.
⢠Diagnosis of mental health disorder, specifically diagnosis of the most common mental health disorders in the community (anxiety and stress disorder; depression; alcohol use disorder; drug use disorder; bipolar and affective mood disorder).
⢠Diagnosis of neurodegenerative disease, specifically diagnoses of common dementias and neurodegenerative diseases (all neurodegenerative diseases; dementia not otherwise specified; Alzheimerâs disease; non-Alzheimerâs dementias; motor neuron disease; and Parkinsonâs disease)
⢠Prescribing of medications for dementia, specifically prescribing of drugs listed under Section 4.11 of the British National Formulary.Description: Technical Summary
A history of traumatic brain injury (TBI) is recognised as a major risk factor for neurodegenerative disease (NDD), with around 3-15% of dementia in the community thought to be a consequence of prior TBI exposure. In line with this, former contact sports with histories of exposure to repetitive TBI and head impacts have high risk of neurodegenerative disease when compared to general population datasets. However, reasons why TBI might increase risk of NDD remain uncertain. Studies of TBI outcomes in the general population report that wider general health is also impacted, including higher rates of cardiovascular disease and mental health disorder in TBI survivors, which are, in themselves, recognised risk factors for NDD. However, in contrast to these general population data, observations in former athletes report better wider health, including lower cardiovascular disease and mental health disorder.
The relationship between TBI and risk of NDD is complex and likely to reflect an interaction between the direct consequences of the injury to the brain and the influence of TBI on wider systemic health, in turn, indirectly impacting on brain health. To better understand the relationship between TBI and late NDD risk there is a need to gain a more holistic insight into lifelong health outcomes following TBI exposure and their potential interactions in modifying risk.
We will contrast baseline TBI vs. n=3 controls matched for age, sex, deprivation and years of up-to-standard (UTS) data, in terms of subsequent mortality and mental health outcomes. Participants will require at least 7 years up to UTS: one for exposure, one for covariate ascertainment, and five years for condition incidence (where a GOLD UTS date is assigned to a CPRD practice and the data recorded by the practice are of an acceptable research standard). Conditions will be based on a priori Read/SNOMED code lists.
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Urban-rural comparison of access to care and health outcomes for five major health conditions related to cardio-metabolic diseases, mental health and infectious diseases in England — Till Bärnighausen ...
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Urban-rural comparison of access to care and health outcomes for five major health conditions related to cardio-metabolic diseases, mental health and infectious diseases in England
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-26
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Maxime Inghels - Corresponding Applicant - University Of Lincoln
David Nelson - Collaborator - University Of Lincoln
Engelbert Bain Luchuo - Collaborator - University Of Lincoln
Frank Tanser - Collaborator - University Of Lincoln
Julia Lemp - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Zahid Asghar - Collaborator - University Of LincolnOutcomes:
Primary outcomes:
Related to Ischaemic heart disease: Atherosclerotic cardiovascular disease; ischaemic heart disease (suspected or diagnosed); time to ischaemic heart disease diagnosis; time to ischaemic heart disease treatment; number of cardiovascular disease-related emergency hospitalizations; number of severe adverse health events (diabetic coma, stroke, heart attack [myocardial infarction] â each event type evaluated separately); all-cause mortalityRelated to diabetes: type 2 diabetes diagnosis ; time to type 2 diabetes diagnosis; time to type 2 diabetes treatment; number of all-cause emergency hospitalizations; number of diabetes-related and cardiovascular disease-related emergency hospitalizations; number of severe adverse health events (e.g. diabetic coma, stroke, heart attack [myocardial infarction] â each event type evaluated separately); all-cause mortality.
Related to depressive disorder: type of depressive disorder (e.g. seasonal, recurrent, single episode); time to depressive disorder diagnosis; time to depressive disorder treatment; number of episodes of depressive disorder; number of attendances to a day care facility where the function classification is 'mental illness', score of perception of behaviour and emotional disability impact, number of severe adverse health events (e.g. suicide attempt), number of mental-health-related hospitalizations (emergency or not) ; all-cause mortality.
Related to influenza and pneumococcal infection: number of influenza episodes; number of Invasive Pneumococcal Disease episodes; time from diagnosis to treatment; immunization; number of severe adverse health events (e.g. pneumonia, meningitis, bacteraemia, chronic pulmonary disease or congestive heart failure â each event type evaluated separately); all-cause mortality
Secondary outcomes:
All health conditions considered: Probability of at least one all-cause emergency hospitalization; probability of at least one diabetes-related and cardiovascular disease-related emergency hospitalization; number of all-cause hospitalizations; probability of at least one all-cause hospitalization; number of diabetes-related and cardiovascular disease-related hospitalizations; number of mental health related hospitalizations; number of influenza and pneumococcal infection-related hospitalizations; probability of at least one all-cause hospitalization; probability of at least one diabetes-related and cardiovascular disease-related hospitalizations; probability of at least one mental health-related hospitalizations; probability of at least one influenza and pneumococcal infection-related hospitalizations; probability of at least one severe adverse health event; Ischaemic heart disease complications (e.g. chest pain or angina, heart attack, heart failure, arrhythmia); diabetic complications (e.g. ophthalmic, neurological and renal complications of diabetes); depressive disorder complications (e.g. major depression, substance abuse, suicidal behavior); influenza and pneumococcal infection complications (e.g. myocarditis, respiratory and kidney failure, meningitis, bacteremia, pneumonia); hypertension; BMI; smoking; alcohol consumption; HbA1c; fasting plasma glucose; cholesterol, HDL cholesterol, LDL cholesterol and non â HDL cholesterol, triglycerides.Description: Technical Summary
Technical summary
The main objective of this study is to ascertain how residential context (rural-urban) shapes the care pathway and health outcomes for five conditions (Ischaemic heart disease, diabetes, depressive disorders, influenza and pneumococcal infections). A retrospective cohort study will be conducted among patients exposed to these health conditions and seen in consultation since 1 January 2010. The primary exposure will be the rural/urban category as defined by the Office of National Statistics. The study will consider two type of outcomes: (i) the outcomes related to care step access for the five health conditions considered (i.e. access to diagnosis, access to treatment and âfor preventable diseaseâ access to immunization), (ii) the differential effect on treatment which will be measured using the occurrence of adverse events (e.g. death for ischaemic heart disease, suicide attempt for depressive disorders).
Outcomes related to patient care pathways and treatment outcomes will be collected through the following datasets: Hospital Episode Statistics (HES) Admitted Patient Care and HES Diagnostic Imaging Dataset (e.g. for the diagnosis of Ischaemic heart disease). For the case of depressive disorders, we use the Mental Health Data Set and HES Accident and Emergency (for measure suicide attempt). Pregnancy Register for pregnant women will be used to measure access to pneumococcal infection and influenza immunization for pregnant women.
Analysis will be adjusted on individualsâ characteristics and their sociodemographic environment, using Patient Level Index of Multiple Deprivation. Access to each care pathway step and treatment outcome will be investigated using Cox proportional hazards regression.
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Comorbidity among patients receiving opioid substitution therapy: examination of primary and secondary healthcare utilisation, cost of care, drug-drug interactions and mortality risk. — Darren Ashcroft ...
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Comorbidity among patients receiving opioid substitution therapy: examination of primary and secondary healthcare utilisation, cost of care, drug-drug interactions and mortality risk.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-15
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Eleni Domzaridou - Corresponding Applicant - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Thomas Allen - Collaborator - University of Manchester
Tim Millar - Collaborator - University of ManchesterOutcomes:
ï§ Non-fatal/fatal overdose
ï§ Adverse events due to drug-drug interactions:
- Ventricular arrhythmia
- Cardiac failure
- Overdose
ï§ Primary and secondary care resource utilisation and associated costs of careDescription: Technical Summary
Although elevated risk of drug-related death occurring during opioid substitution therapy (OST) initiation and after cessation has been widely reported, limited research has been conducted on the potential impact that chronic diseases might have on hospitalisation due to non-fatal overdose and drug-related death. A substantial number of deaths in this population are premature and are potentially preventable. There are theoretical drug-drug interactions (DDIs) between OST and commonly prescribed medication (e.g. antidepressants, anxiolytics, antibiotics, antiarrhythmics, antiepileptics), that have not been examined and that may result in serious cardiovascular or respiratory-related events. The impact of specific comorbidities on OST choice, drug safety, and healthcare costs is poorly understood.
We plan to utilise interlinked primary and secondary care records, area-level deprivation, and mortality data. We will delineate a cohort of patients who have received OST, based on prescription codes in the CPRD GOLD and Aurum databases. We will calculate and apply propensity scores to balance baseline covariates between methadone and buprenorphine recipients. Hazard ratios (and their 95% Confidence Interval) will be generated by fitting Cox proportional hazards models to examine whether patients who receive methadone versus those who receive buprenorphine have an elevated risk of non-fatal/fatal overdose. Moreover, we will include an interaction term to examine the potential effect modification of specific diseases (e.g. cardiovascular, respiratory, digestive system, or kidney diseases) on non-fatal/fatal overdose compared to opioid-dependent patients who were unaffected by these diseases. We will also assess the risk of harm that DDIs may have by applying the self-controlled case-series methodology. We will also apply regression models with interaction terms to investigate if primary and secondary care resource utilisation and associated costs in England differ between methadone and buprenorphine recipients and between patients with and without specific chronic conditions.
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Multimorbidity and health care outcomes in patients with Rheumatoid Arthritis and Psoriatic Arthritis — Bhautesh Jani ...
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Multimorbidity and health care outcomes in patients with Rheumatoid Arthritis and Psoriatic Arthritis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-26
Organisations:
Bhautesh Jani - Chief Investigator - University of Glasgow
Bhautesh Jani - Corresponding Applicant - University of Glasgow
Barbara Nicholl - Collaborator - University of Glasgow
Frances Mair - Collaborator - University of Glasgow
Fraser Morton - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Mohammad H Derakhshan - Collaborator - University of Glasgow
Philip McLoone - Collaborator - University of Glasgow
Srinivasa Vittal Katikireddi - Collaborator - University of Glasgow
Stefan Siebert - Collaborator - University of GlasgowOutcomes:
Primary Outcomes
⢠Prevalence of long-term physical and mental health conditions co-occurring in patients diagnosed with rheumatoid or psoriatic arthritis.Secondary Outcomes
⢠Number of primary care consultations (in-person or by phone)
⢠Number of repeat prescriptions (at least four times in a year by counting the unique British National Formulary (BNF) codes) per patient
⢠Number of hospital admissions (defined by discharge dates)
⢠Incidence of major adverse cardiovascular events after diagnosis
⢠Mortality (all cause and cardiovascular) after diagnosisDescription: Technical Summary
In order for health services to meet the health needs of patients who experience inflammatory arthritis in conjunction with other chronic conditions the prevalence of multimorbidity among patients with arthritis, and its association with health service use and health outcomes must be better understood.
We are planning an epidemiological study to look at multimorbidity among patients with two types of inflammatory arthritis (psoriatic or rheumatoid). It will consist of both a cross-sectional, descriptive study of the prevalence of multimorbidity, and different patterns of multimorbidity along with a retrospective cohort analysis investigating the relationship between multimorbidity and different patterns of multimorbidity and health service utilisation and health outcomes. We will describe the prevalence of long-term conditions, and use latent class analysis to create multimorbidity profiles to differentiate patients with different combinations of long term conditions.
In the retrospective open-cohort aspect of our study, we will use multivariable regression models to examine how use of health services and health outcomes vary according to multimorbidity profile. Our outcomes will include the number of GP consultations, the number of prescriptions dispensed, and the number of hospitalisations. We will also compare the risk of death and major cardiac events.
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Assessing the quality and uptake of incentivised physical health checks for people with serious mental illness — Panagiotis Kasteridis ...
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Assessing the quality and uptake of incentivised physical health checks for people with serious mental illness
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-29
Organisations:
Panagiotis Kasteridis - Chief Investigator - University of York
Panagiotis Kasteridis - Corresponding Applicant - University of York
Luis Fernandes - Collaborator - University of York
Maria Jose Aragon Aragon - Collaborator - University of York
Najma Siddiqi - Collaborator - University of York
Nils Gutacker - Collaborator - University of York
Rowena Jacobs - Collaborator - University of YorkOutcomes:
Interventions following Physical Health Checks in primary care; Probability and timing of receiving Physical Health Checks in primary care; Uptake of Physical Health Checks
Description: Technical Summary
Background
To promote physical health monitoring, the Quality and Outcomes Framework (QOF) provides financial rewards to GPs to conduct an annual review of the patientâs physical health including seven physical health checks (PHCs): cervical screening, alcohol consumption, smoking status, blood pressure, cholesterol, body mass index, and blood glucose. Despite the incentives provided, not every patient receives annual PHCs. Increasing the uptake of PHCs for people with Serious Mental Illness (SMI) has become a high policy priority for NHS England.Objectives
Our objective is to provide a detailed understanding of the quality and uptake of PHCs for people with SMI. We expect this work to impact on policymakers by providing detailed information about the content and delivery of PHCs, and guide GPs and commissioners on developing personalisation approaches of whom to target to increase uptake of PHCs.Methods
We will undertake patient-level analysis using primary care data from the Clinical Practice Research Datalink for the financial years 2006-2020.
First, we will assess the quality of PHCs based on whether they trigger appropriate interventions. PHCs and related interventions will be identified by relevant clinical codes. We will use descriptive analysis to present variation in quality across PHCs and to what extent quality differences are associated with patient characteristics, organisational factors, and PHCs being recorded close to the QOF reporting period deadline.
Second, we will explore factors that constitute barriers to receiving PHCs thus generating health inequalities. We will employ semi-parametric Cox hazard models to examine how patient and practice characteristics affect the timing of receiving a PHC. We will employ differences-in-differences methodology to assess the impact of removing financial incentives from three PHCs on uptake. We will use interrupted times series to assess the impact on uptake of a policy requiring clinical commissioning groups to report on the delivery of PHCs.
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Is there an association between antibiotic exposure and Parkinson disease? — Gian Pal ...
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Is there an association between antibiotic exposure and Parkinson disease?
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-07
Organisations:
Gian Pal - Chief Investigator - Rutgers, The State University of New Jersey
Gian Pal - Corresponding Applicant - Rutgers, The State University of New Jersey
Abner Nyandege - Collaborator - Rutgers, The State University of New Jersey
Daniel Horton - Collaborator - Rutgers Robert Wood Johnson Medical School
Jason Roy - Collaborator - Rutgers, The State University of New Jersey
M. Maral Mouradian - Collaborator - Rutgers Robert Wood Johnson Medical School
Tobias Gerhard - Collaborator - Rutgers, The State University of New JerseyOutcomes:
Parkinsonâs disease diagnosis
Description: Technical Summary
Studies have posited that exogenous factors such as antibiotics, that lead to disruption of the intestinal microbiome (dysbiosis), might play a critical role in triggering Parkinsonâs disease (PD). A recent study in Finland by Mertsalmi et al. (2019) suggested that healthy individuals who received one or more courses of antibiotics had an increased risk of PD approximately 10-15 years after exposure.
We propose a case-control study using CPRD to examine the potential association between antibiotic exposure and PD risk. Unlike the study from Finland, we will: (1) adjust for smoking, an important confounder for PD risk, (2) study a more diverse population than that of Finland, (3) and examine the indications for antibiotic use, since different types of infections (e.g., GI vs. respiratory) may themselves trigger PD to varying degrees.
The outcome of interest is the odds ratio (OR) of antibiotic exposure (according to class of antibiotics) and risk of PD.
We will select all patients who were discharged from 1994 to 2019 with a diagnosis of PD. For each PD patient, 10 control subjects of the same age (+/-1 year) and sex, living in a similar practice region, and IMD quantile, will be selected. For controls, data will also be acquired for the year 2020 to exclude subjects who already suffered from early PD in 2019 but who were only diagnosed in 2020.
The odds ratio (OR) and 95% conï¬dence intervals (CI) will be estimated for the association between PD and number of antibiotic courses by conditional logistic regression. Then, a multivariate logistic regression will be used to adjust for potential confounders.
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Prediction of significant bleeding during anticoagulant use in patients with cancer-related venous thromboembolism: an English cohort study. — Ayman Nassar ...
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Prediction of significant bleeding during anticoagulant use in patients with cancer-related venous thromboembolism: an English cohort study.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-29
Organisations:
Ayman Nassar - Chief Investigator - Bristol Myers Squibb - Europe ( BMS )
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Raza Alikhan - Collaborator - University Hospital of Wales
Sarah Grundy - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Satarupa Choudhuri - Collaborator - Not from an OrganisationOutcomes:
Significant bleeding including major bleeding in outpatients;
Clinically-relevant non-major bleeding requiring hospitalization;Description: Technical Summary
This observational cohort study aims to investigate predictors for the risk of significant bleeding during anticoagulant (AC) treatment for active cancer associated venous thromboembolism (CAT).
A cohort of patients with venous thromboembolisms (VTEs), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), between 01/04/2008 and 31/10/2020, a cancer recording within 180 days before the VTE and recorded AC use within 90 days after the CAT will be defined.
The outcome of interest will include major bleeding and clinically-relevant non-major bleeding requiring hospitalization (CRNMB-H) within 180 days after CAT and will be defined from general practitioner (GP) diagnoses, hospital discharge diagnoses and causes of death.
Potential predictors for bleeding events will include clinical and laboratory variables identified as components in published risk scales for bleeding in AC use and other potential predictors mentioned in published literature.
Multivariate Fine and Gray regression models accounting for the competing risk mortality will be used to estimate subdistribution hazard ratios (SHRs) for all potential bleeding event predictors. The scoring scheme for the prediction of bleeding events will be developed from these SHRs. The discrimination of the new score, will be assessed by estimation of C statistics using cross validation. In addition, discrimination will be compared directly to existing clinical scores to predict bleeding in patients with VTE. To assess the calibration of the score, the study cohort will be split into 5 subgroups based on quintiles of risk. Within each of these 5 subgroups the observed and expected number of bleeding cases will be compared and a goodness of fit test will be performed.
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Risk of Abnormal Uterine Bleeding associated with direct oral anticoagulants compared with Vitamin K antagonists — Samy Suissa ...
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Risk of Abnormal Uterine Bleeding associated with direct oral anticoagulants compared with Vitamin K antagonists
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-29
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Haim Abenhaim - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Harika Dasari - Collaborator - Harvard University
Jonathan Michaud - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sonia Hernandez-Diaz - Collaborator - Harvard UniversityOutcomes:
Primary outcome: Abnormal uterine bleeding (Read codes and SNOMED-CT concept IDs outlined in Appendix 1)
Secondary outcome: anaemiaDescription: Technical Summary
Anticoagulants are the treatment of choice in venous thromboembolism (VTE) and pulmonary embolism (PE). They are also prescribed in patients with nonvalvular atrial fibrillation (NVAF) in the prevention of stroke. Vitamin K-antagonists (VKAs), such as warfarin, have been the standard oral anticoagulant treatment for several decades. Direct oral anticoagulants (DOACs) are newer oral anticoagulants that specifically inhibit specific clotting factors. The efficacy, safety, and convenience of DOACs have led these agents to become the new standard of care. In particular, DOACs are associated with a lower risk of major bleeding such as intracranial haemorrhage compared with VKAs. However, the risk of gender-specific bleeding such as abnormal uterine bleeding associated with DOACs is unknown. Early experiences in using DOACs suggests an increase in heavy menstrual bleeding in women taking rivaroxaban, currently the main DOAC used for VTE treatment in the UK. Thus, we will conduct a population-based cohort study to assess whether the use of DOACs is associated with the incidence of abnormal uterine bleeding. We will form a cohort of all women aged between 15 and 50 years old newly prescribed DOACs or VKAs between 2008 and 2020. We will use Cox proportional hazards models to estimate hazard ratios with 95% confidence intervals of abnormal uterine bleeding associated with the use of DOACs compared with VKAs. In secondary analyses, we will assess whether this risk varies with duration of DOAC use and with indication for anticoagulation. Several sensitivity analyses will be performed to assess the robustness of our results.
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A retrospective database analysis to estimate the burden of pneumococcal disease in children 0-17 years in England — Salini Mohanty ...
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A retrospective database analysis to estimate the burden of pneumococcal disease in children 0-17 years in England
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-05
Organisations:
Salini Mohanty - Chief Investigator - Merck & Co. Inc - Pennsylvania, USA
Bélène Podmore - Corresponding Applicant - OXON Epidemiology - Spain
Eric Sarpong - Collaborator - Merck & Co., Inc.
Ian Matthews - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Jessica Weaver - Collaborator - Merck & Co., Inc.
Julia Agúndez - Collaborator - OXON Epidemiology - Spain
Laura Spowart - Collaborator - MSD Vaccins
Lorena Baquero Portela - Collaborator - OXON Epidemiology - Spain
Nawab Qizilbash - Collaborator - OXON Epidemiology - Spain
Rebeca Gonzalez Eriksen - Collaborator - OXON Epidemiology - Spain
Sergio Eslava - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Susan Farrow - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Tianyan Hu - Collaborator - Merck & Co. Inc - Pennsylvania, USAOutcomes:
The primary outcomes to be measured are:
- Incidence rates of IPD, pneumonia and AOM episodes
- Case Fatality Rates associated with inpatient IPD and pneumonia admissions
- HCRU associated with IPD, pneumonia and AOM episodes:
⢠Number of inpatient admissions
⢠Total inpatient length of stay
⢠Number of GP visits
⢠Number of GP antibiotic prescriptions
- Costs associated with IPD, pneumonia and AOM episodes:
⢠Inpatient cost
⢠GP visit cost
⢠GP prescription cost
⢠Total costsThe secondary outcomes to be measured are:
- Incidence of simple vs. recurrent AOM
- HCRU and costs associated with simple vs. recurrent AOM
- Proportion of meningitis hospitalizations resulting in sequelae at the time of hospital discharge
- HCRU and Costs associated with managing meningitis sequelae
- AOM incidence during UKâs RSV season with incidence of retrospective bronchiolitis or RSV diagnosis during the previous 14 daysDescription: Technical Summary
The aim of this study is to examine invasive and non-invasive pneumococcal disease incidence in England in primary care and inpatient settings from 2003 to 2019, including before and after the introduction of PCV7 and PCV13 vaccines and the late post PCV13 period. The study will additionally estimate healthcare resource utilisation (HCRU) and costs associated with these episodes.
Incidence rates for invasive pneumococcal disease (IPD), pneumonia and acute otitis media (AOM) episodes will be estimated separately for each calendar year over the entire study period. Episodes will be created using information from inpatient and primary care settings.
Case fatality rates will be assessed to measure the severity of IPD and pneumonia in hospitalised children. HCRU and costs will be estimated annually for IPD, pneumonia and AOM episodes and compared across pre and post PCV time periods. HCRU will include the number of hospitalisations, average length of stay in hospital, number of GP visits, and number of antibiotic prescriptions in primary care for IPD, pneumonia and AOM episodes. The demographic characteristics and known risk factors associated with IPD, pneumonia and AOM episodes will also be described. The annual incidence of simple versus recurrent AOM will be estimated as well as the HCRU and costs associated to these episodes.
Exploratory analyses related to meningitis complications, will also describe the number of hospitalisations as well as the sequalae at discharge, the HCRU and costs during the year after the meningitis hospitalisation.
For each period between October to March, the incidence of AOM will also be calculated and then retrospectively the Respiratory Syncytial Virus (RSV) and bronchiolitis incidence during the previous 14 days.
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Incidence, Prevalence of Multiple Sclerosis in CPRD Â Burden of Mortality, Infection and Cancer Among Patients With Multiple Sclerosis — Pam Jayia ...
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Incidence, Prevalence of Multiple Sclerosis in CPRD Â Burden of Mortality, Infection and Cancer Among Patients With Multiple Sclerosis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-12
Organisations:
Pam Jayia - Chief Investigator - Roche
Boris Addow - Corresponding Applicant - Roche
Ana Ruigomez - Collaborator - CEIFE
Luis Alberto Garcia Rodriguez - Collaborator - CEIFE
Oscar Fernandez-Cantero - Collaborator - CEIFEOutcomes:
Prevalence and incidence rate of multiple sclerosis (MS) in the UK general population.
Incidence of infections in MS population and in the general population free of MS.
All-cause mortality in MS population and the general population free of MS.
All cancer and breast cancer incidence in particular, among MS population and the general population.Description: Technical Summary
Multiple Sclerosis (MS) is estimated to affect to more than 2.3 million people worldwide. The chronic course of MS is associated with a high morbidity burden, and an underlying predisposition to infections, including opportunistic infections. Both systemic and central nervous system (CNS) infections are major complications of MS.
We aim to investigate the natural history of MS in UK, describing the characteristics of these patients and explore the occurrence of infections and cancer among patients with MS compared to the general population (free of MS).
Primary Objectives: to estimate the prevalence and incidence rate of MS in the UK general population, and describe the distribution of comorbidity and co-medication in a MS population. As well as to estimate and compare the incidence of infections in MS and general population cohorts.
Secondary Objectives: to estimate and compare all-cause mortality rate and cancer and breast cancer incidence in particular in both study cohorts.
This is a population-based retrospective cohort study, using the CPRD database with available links (hospitalization, death). During the enrolment period (1/1/2000-31/12/2016), all individuals aged 2-79 years of age, registered for at least two years in CPRD database will be included. And we will ascertain the two study cohorts: 1) patients with MS recorded diagnosis and 2) comparison general population cohort (free of MS), random sample frequency-matched to individuals in the MS cohort. Among both cohorts we will ascertain the first occurrence of infection, cancer and death during study follow-up.
Statistical analyses will be performed using STATA, estimating rates of MS and outcomes, detailed descriptive analyses of demographic, co-medications and comorbidities variables. Survival analysis and multivariate Cox hazards model to estimate the adjusted hazard ratios of mortality/outcome in both cohorts. Separate nested case-control analyses will be performed, one per study outcome if numbers permit.
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Understanding clusters and mechanisms of complex multimorbidity in people with common allergic conditions — Sinead Langan ...
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Understanding clusters and mechanisms of complex multimorbidity in people with common allergic conditions
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-06
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Amy Mulick - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Alasdair Henderson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Aziz Sheikh - Collaborator - University of Edinburgh
David McAllister - Collaborator - University of Glasgow
David Prieto-Merino - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jennifer Quint - Collaborator - Imperial College London
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ronan Lyons - Collaborator - Swansea University
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Our final outcomes summaries are associations between comorbidities- multiple health conditions including allergic and non-allergic morbidity (with and without directionality) and patterns of comorbidity clusters, which we will compare between exposed and unexposed groups that can vary depending on asthma and atopic eczema status. To find these clusters, we will use population-level metrics derived from regression analyses on individual-level data.
Description: Technical Summary
Our study aims to characterise known and novel clusters of multimorbidity (known and novel) in common allergic disorders (asthma and atopic eczema).
We will identify anonymised records of adults with asthma or eczema in CPRD-GOLD using algorithms based on morbidity codes in primary care data. We will apply data-driven techniques to identify disease clusters (multimorbidity, defined using Read code chapters) in people with common allergic diseases, including previously described morbidity (e.g., cardiovascular diseases, fractures). This exploratory research will offer insights into pathways to multimorbidity, potentially allowing us to identify novel disease clusters not previously linked to allergic conditions (i.e., non-random clustering), highlighting avenues for subsequent research.
We will use logistic regression with individual level data to derive associations (Odds Ratios) between comorbidities. By modelling individuals together (people with asthma and atopic eczema separately [cases] matched on age, sex and practice with individuals without these conditions [control]) and including a comorbidity variable as the outcome (e.g. cardiovascular) and another comorbidity variables as exposures (e.g. respiratory, renal, etc.). By including an interaction term between exposure comorbidity and individual case-control status, we will test if associations between comorbidities varies across groups. We will visualise associations between comorbidities as networks in each patient group and identify clusters of highly associated comorbidities within networks. Clusters will be reviewed by subject-matter experts and patients for clinical plausibility. Clusters might suggest temporally-ordered sequences of diagnoses that we will visualise to illustrate disease progression over time. Logistic models can be adapted to estimate associations of sequence of events (e.g. A -> B) by defining appropriately event B as the outcome and only preceding A events as exposures. Sequential associations can be visualised using directed networks. We will compare networks and clusters between groups with a differential analysis of the edges and comparing overall network metrics (centrality, connectivity, etc.).
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A retrospective, observational, real world study to describe the treatment pathway, healthcare resource utilisation, and clinical outcomes in patients with metachromatic leukodystrophy — ...
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A retrospective, observational, real world study to describe the treatment pathway, healthcare resource utilisation, and clinical outcomes in patients with metachromatic leukodystrophy
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-05
Organisations:
- Chief Investigator -
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
David Heaton - Collaborator - Harvey Walsh Ltd
Matthew O'Connell - Collaborator - Harvey Walsh Ltd
Michael Wallington - Collaborator - OPEN VIE
Rhiannon Thomason - Collaborator - Harvey Walsh Ltd
Tracey Ellison - Collaborator - Harvey Walsh LtdOutcomes:
Primary and secondary care resource use; co-morbidities; MLD-related symptoms treatments and equipment; survival; underlying cause of death; haematopoietic stem cell transplant (HSCT)-related complications.
Description: Technical Summary
MLD is a rare genetic disorder which affects the nervous system and shortens life-expectancy. The study will describe a population of patients with an MLD diagnosis recorded on CPRD. The study aims to describe the annual healthcare resource utilisation and costs associated with management of patients with MLD using CPRD (Aurum and Gold) for primary care resources, and HES inpatient, outpatient and A&E data for secondary care resources. Primary care resource analyses will include consultations, prescriptions and laboratory and diagnostic tests. Secondary care resource utilisation will include inpatient (including total admitted time, admissions/bed days), outpatient appointments and A&E. Speciality and elective/non-elective admissions and those to Intensive care and high dependency units, will be reported. Rates will be reported by year pre- and post-diagnosis and by year from diagnosis (including mean, standard deviation/ median, interquartile range, and range). Costing will be based on HES generated Health Resource Group (HRG), including inpatient, outpatient, and A&E tariff costs, and Personal Social Services Research Unit reference costs and the British National Formulary.
In addition, the study population will be described in terms of age at first symptom or diagnosis, sex (mean, SD, median, and ranges), observed survival (overall and from diagnosis by Kaplan Meier plot and 5-year from CPRD), and the distribution of the underlying cause of death (ONS). The rate of post-diagnosis MLD-related treatments, including the proportion of patients who received haematopoietic stem cell transplant (HSCT) and the proportion of this subgroup with complications, equipment and co-morbidities, and pre-diagnosis co-morbidities and MLD-related symptoms will be reported (all CPRD and HES).
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Diagnosing COPD: Survey of Patient Experience across the UK — Alex Bottle ...
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Diagnosing COPD: Survey of Patient Experience across the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-15
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Alex Bottle - Corresponding Applicant - Imperial College London
Benedict Hayhoe - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Rupa Sisodia - Collaborator - Imperial College LondonOutcomes:
⢠Patient perspectives & experiences from initial onset of symptoms through to diagnosis.
⢠Symptoms experienced prior to diagnosis.
⢠Time taken from initial symptoms to first presentation to the health service and to subsequent diagnosis of COPD.As there is no facility in ERAP to respond to comments, I will do this here. I need to respond to specific points on the survey relating to i) would patients be able to distinguish between urban, suburban and rural and ii) Where is the explanation that patients have been recruited via their records and stated to have COPD?
Re i), self-reported answers to this are sufficient for our purposes, and our PPI reps and pilot testers believe that this is fine (see PPI section). Re ii) this is stated in the patient information sheet that will be sent to patients with the survey. It is not possible to upload the PIS as an appendix within ERAP as this is a revised protocol (a known issue with ERAP).Description: Technical Summary
Background: COPD is the fourth leading cause of death worldwide and accounts for 30,000 deaths each year in the UK. According to the Global Burden of Disease project, COPD caused 2.6% of global disability-adjusted life years in 2015 â the eighth most important disease on this measure. In the UK, 115,000 people are diagnosed with COPD each year â one every 5 minutes on average. There is limited understanding of what takes place between the initial onset of symptoms through to the eventual diagnosis of COPD. Our aim is to describe the patientsâ perspective and experience of how they got their diagnosis and how long it took.
Methods: An online questionnaire-based survey will be administered to eligible patients with COPD by their GP (identified as having COPD in CPRD, aged over 35 and able to give informed consent). This will give us an insight into the challenges and experiences faced by patients in getting their COPD diagnosis across the UK. CPRD records for those eligible patients will be inspected for patient characteristics such as age, gender, UK region, smoking and BMI.
Results: Descriptive statistics will characterise the COPD population and their survey responses.
Conclusion: The findings will feed into a larger risk-prediction modelling project that has ISAC approval; that project will also administer the proposed patient survey through the charity website and Twitter. The aims of the larger project are to understand the routes to diagnosis and first acute exacerbation, model the first acute exacerbation, and to inform the National Audit and NICE on appropriate measures and guidelines for diagnosis and management of COPD.
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Direct oral anticoagulants (DOAC) dosing patients with non-valvular atrial fibrillation (NVAF): a retrospective cohort study using the Clinical Practice Research Datalink (CPRD) Gold database — Artak Khachatryan ...
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Direct oral anticoagulants (DOAC) dosing patients with non-valvular atrial fibrillation (NVAF): a retrospective cohort study using the Clinical Practice Research Datalink (CPRD) Gold database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-18
Organisations:
Artak Khachatryan - Chief Investigator - LA-SER Europe Ltd ( Certara )
Yousef Zawaneh - Corresponding Applicant - LA-SER Europe Ltd ( Certara )
Farhan Mughal - Collaborator - Daiichi Sankyo
gaelle gusto - Collaborator - LA-SER Europe Ltd ( Certara )
Georgios Spentzouris - Collaborator - Daiichi-Sankyo Europe
Jolanta Wrotniak-Vucic - Collaborator - LA-SER Europe Ltd ( Certara )
Umesh Doobaree - Collaborator - LA-SER Europe Ltd ( Certara )Outcomes:
1- Major bleeding (bleeding leading to hospitalization)
2- Stroke (any; hemorrhagic stroke; ischemic stroke)
3- Systemic embolism
4- All-cause mortalityDescription: Technical Summary
NVAF is an atrial tachyarrhythmia characterized by predominantly uncoordinated atrial activation with consequent deterioration of atrial mechanical function. European Society of Cardiology (ESC) Guidelines (2020) have underlined the importance of direct oral anticoagulants (DOAC) for stroke prevention compared to standard anticoagulants in NVAF. One of the major problems with the management of DOACs is that in routine practice, doses are often inconsistent with drug labelling which may be associated with worse outcomes. The aim of this study is to investigate DOAC (apixaban, rivaroxaban, dabigatran and edoxaban) dosing patterns and associated outcomes in patients treated in routine clinical practice in the UK.
This study will employ a retrospective cohort design and will source its study population from the CPRD Gold. All NVAF patients who initiated treatment with a DOAC (apixaban, rivaroxaban, dabigatran, or edoxaban) from the 1st January 2016 to 30th June 2019 will be included in the study. Patients with a history of end stage renal failure, venous thromboembolism, or valvular heart surgery. Anyone with more than one DOAC or has received heparin at initiation of a DOAC in the study period or had a fracture or surgery to the knee, hip or pelvis will be excluded too. The study will aim to describe the demographic, clinical characteristics, treatment pattern, including dose (underdosing, standard dosing), duration, switching, and discontinuation, of NVAF patients on DOAC treatments and the clinical outcomes in patients on a reduced dose with no indication for dose reduction.
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Prevalence estimate of atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease -risk equivalent and familial hypercholesterolaemia patients with elevated low-density lipoprotein cholesterol. — Christopher Morgan ...
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Prevalence estimate of atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease -risk equivalent and familial hypercholesterolaemia patients with elevated low-density lipoprotein cholesterol.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-07
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Cerys Jenkins - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Adeline Durand - Collaborator - Novartis UKOutcomes:
Prevalence; therapy use
Description: Technical Summary
It has been shown in clinical and real-world studies that elevated levels of low-density lipoprotein cholesterol (LDL-C) are strongly associated with cardiovascular disease and risk of stroke and myocardial infarction. Pharmacological interventions to reduce LDL-C has been shown to be associated with reduced incidence of atherosclerotic cardiovascular disease (ASCVD). However, a large proportion of patients with elevated LDL-C have been shown to be either intolerant or else refractory to conventional cholesterol lowering regimens. In particular, those patients with familial hypercholesterolemia whose LDL-C may be grossly increased are difficult to manage. Inclisiran is a subcutaneously delivered therapy that has been shown in clinical trials to reduce refractory LDL-C in patients with ASCVD and familial hypercholesterolaemia. Novartis are interested in understanding the prevalence of these populations. In this study we wish to conduct a non-comparative, retrospective study using the Clinical Practice Research Datalink (CPRD) GOLD database. Three cohorts of patients with elevated LDL-C will be selected from CPRD GOLD, with either i) familial hypercholesterolemia, ii) history of ASCVD (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or iii) primary prevention with elevated risks (PPER) based on either comorbidity (type II diabetes or familial hypercholesterolemia) or Framingham risk score indicative of >20% risk of a cardiovascular event within 10 years. These cohorts will not be mutually exclusive. We then wish to calculate the point prevalence of each cohort population for 2018 within the four nations of the United Kingdom and the proportions of these patients treated with statins, exenatide or defined as statin intolerant.
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Prevalence and incidence of mental health conditions in children and young people with intellectual disabilities in England — Kirsty Dunn ...
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Prevalence and incidence of mental health conditions in children and young people with intellectual disabilities in England
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Mental Health Services Data Set (MHSDS); Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-25
Organisations:
Kirsty Dunn - Chief Investigator - University of Glasgow
Kirsty Dunn - Corresponding Applicant - University of Glasgow
Craig Meville - Collaborator - University of Glasgow
Douglas McConachie - Collaborator - Not from an Organisation
Ewelina Rydzewska - Collaborator - University of Glasgow
Maria Truesdale - Collaborator - University of Glasgow
Michael Fleming - Collaborator - University of Glasgow
Richard Hastings - Collaborator - University of WarwickOutcomes:
Lifetime period prevalence and incidence of mental health conditions (age post-diagnosis of ID-24); Prevalence and incidence of psychotropic medication prescribing (age 0-24) for patients with mental health conditions; Prevalence and incidence of referrals to a child, adolescent or adult psychiatry, psychotherapy, clinical psychology, or the community psychiatric nurse (age 0-24) for patients with and without mental health conditions; Prevalence and incidence of admission to psychiatric services for young people (age 18-24) for patients with and without mental health conditions
Description: Technical Summary
Children and young people with intellectual disabilities are more likely to experience mental ill-health than the general population. However, prevalence rates vary and a number of issues remain with studies in the existing literature, such as diagnostic criteria used. The above studies also rely on data collected from between 1999 and 2011, so they do not give a picture of current prevalence rates or patterns of service use in the UK. Studies which have reported patterns of mental health conditions do not report prevalence of specific mental health conditions, or proportion with mental health conditions who receive psychotropic prescriptions or referrals/admissions to psychiatric services. It is important to gain a clearer picture of specific mental health condition prevalence, as well as prescription and psychiatric service use, for this population in order to target resources effectively.
In this study, we will use data from the Clinical Practice Research Datalink (CPRD) GOLD and Aurum to describe the prevalence and incidence of specific mental health conditions in children and young people, between the study dates of 1 January 2004 and 31st August 2020. CPRD will be linked to the Mental Health Dataset, Practice Level Rural-Urban and Patient Level Index of Multiple Deprivation. We will also describe prevalence and incidence of psychotropic prescriptions, referrals to a child, adolescent or adult psychiatry; psychotherapy; clinical psychology; community psychiatric nurse (0â24 years), and psychiatric admissions among children and young people (18â24 years) with and without intellectual disabilities who have mental health conditions in the UK. Patients will be followed from the point of diagnosis of intellectual disabilities up to age 24 years. Lifetime period prevalence post-diagnosis of intellectual disabilities will be calculated for specific mental health conditions (e.g. depression). Cox proportional hazard modelling for mental health conditions will be undertaken, adjusting for gender, age, and deprivation.
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Comparability and Relative Effectiveness of Osteoporosis Treatment Groups in European Clinical Practice — James O'Kelly ...
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Comparability and Relative Effectiveness of Osteoporosis Treatment Groups in European Clinical Practice
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2021-01-15
Organisations:
James O'Kelly - Chief Investigator - Amgen Ltd
Eng Hooi Tan - Corresponding Applicant - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Francesco Giorgianni - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Primary:
⢠Any fragility fracture (including hip, vertebral, radius, ulna, wrist, humerus, pelvis, shoulder)
Secondary:
⢠Hip fracture
⢠Vertebral fracture
⢠Non-hip non-vertebral fracture
Non-fracture negative control outcomes
⢠Outcomes unrelated to exposure and study outcome (full list in Section N: Exposures, outcomes, and covariates)Description: Technical Summary
Objectives
This study aims to assess the comparability between patients on denosumab and patients on oral bisphosphonates. This will be achieved with the following objectives:
1. To describe osteoporosis treatment groups with respect to demographics, clinical history, and prior medication use
2. To determine whether osteoporosis treatment groups are âadequately comparableâ after adjusting for confounding
3. To compare the incidence of fractures between treatment groups accounting for residual confounding as identified using negative control outcome analyses
Population
Postmenopausal women aged 50 and above, who were prescribed denosumab or oral bisphosphonates between 01 January 2011 and 31 December 2018 and were registered in the Clinical Practice Research Datalink (CPRD) for 1+ years in up-to-standard practicesExposure
The exposure of interest is denosumab 60mg for subcutaneous administration. Comparator exposures are oral bisphosphonates with the indicated doses for treatment of osteoporosis:
- Alendronate (10mg daily or 70mg weekly)
- Ibandronate (150mg once monthly)
- Risedronate (5mg once daily, 35mg once weekly, 75 mg on 2 consecutive days, or 150 mg once monthly)Outcomes
Primary outcome
⢠Any fragility fracture (including hip, vertebral, radius, ulna, wrist, humerus, pelvis, shoulder)
Secondary outcomes
⢠Hip fracture
⢠Vertebral fracture
⢠Non-hip non-vertebral fracture
Non-fracture negative control outcomes
⢠Outcomes unrelated to exposure and study outcome (full list in Section N)
Methods
This study will employ a retrospective cohort design. Summary statistics on demographics, clinical factors, and treatment history in each treatment cohort of interest will be described. Risk for fractures will be calculated via Cox-proportional hazard model over the course of a maximum of 36 months. The following methods to account for measures/unmeasured confounding will be applied:
1) Propensity score (PS) based methods (matching, stratification, and inverse probability of treatment weighting)
2) Negative control outcomes analysis
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ID 102: De-identified Data Access Request: RADAR Project — North West London Health and Care Partnership...
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ID 102: De-identified Data Access Request: RADAR Project
Legal basis:missing
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-21
Opt Outs: no information provided./p>
Organisations: North West London Health and Care Partnership
Description: Diabetes.
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ID 98: NWL COVID-19 Research project Data Access Request Form – School wastewater-based epidemiological surveillance system for the rapid identification of COVID-19 outbreaks (TERM) — Middlesex University...
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ID 98: NWL COVID-19 Research project Data Access Request Form – School wastewater-based epidemiological surveillance system for the rapid identification of COVID-19 outbreaks (TERM)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-21
Opt Outs: no information provided./p>
Organisations: Middlesex University
Description: Covid-19.
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ID 99: NWL COVID-19 Research Project: Data Access Request Form: Understanding Returning Paediatric Emergency Attendance (U-RePEAt) — Imperial College London...
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ID 99: NWL COVID-19 Research Project: Data Access Request Form: Understanding Returning Paediatric Emergency Attendance (U-RePEAt)
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-21
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: missing.
Source
2020 - 12
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Shielded Patient List (SPL) (Identifiable) (Secondary Uses) — Office for National Statistics...
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The COVID-19 Isolation Survey will use telephone interviews to report on whether those asked to self-isolate are following isolation guidelines, whether those who are clinically extremely vulnerable (CEV) understand and follow advice tailored to them, and the effects of such behaviours on physical health and access to healthcare, wellbeing, mental health and life satisfaction, ability to work and financial situation. The results of the survey will be used by the Non-Pharmaceutical Intervention (NPI) sub-group for SAGE and government departments to monitor the adherence to and impacts of isolation strategies. — IG-01507
Recipient Data Controller Organisation(s) : Office for National Statistics
Approval Date: 22/12/2020
Purpose for which the data is being used: The COVID-19 Isolation Survey will use telephone interviews to report on whether those asked to self-isolate are following isolation guidelines, whether those who are clinically extremely vulnerable (CEV) understand and follow advice tailored to them, and the effects of such behaviours on physical health and access to healthcare, wellbeing, mental health and life satisfaction, ability to work and financial situation. The results of the survey will be used by the Non-Pharmaceutical Intervention (NPI) sub-group for SAGE and government departments to monitor the adherence to and impacts of isolation strategies.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Shielded Patient List (SPL)
Demographics (Aggregate (small numbers supressed)) (Secondary Uses) — Local Authorities...
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To present regional and local data, with disease groups, ethnicity and partial postcodes to allow for its use in public health and allow for greater analysis, modelling and planning to be performed using current data to aid in the response to the pandemic. — IG-00613_3
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care Public Health England NHS England CCGs and CSUs NHS Trusts and GP Practices Ministry of Housing, Communities and Local Government
Approval Date: 01/12/2020
Purpose for which the data is being used: To present regional and local data, with disease groups, ethnicity and partial postcodes to allow for its use in public health and allow for greater analysis, modelling and planning to be performed using current data to aid in the response to the pandemic.
Dataset: Shielded Patient List (SPL) Demographics
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Covid-19 Testing Results (Aggregate (small numbers not supressed)) (Secondary Uses) — English Universities...
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For the purposes of delivering COVID related public health decision making. — IG-00637_5
Recipient Data Controller Organisation(s) : English Universities
Approval Date: 16/12/2020
Purpose for which the data is being used: For the purposes of delivering COVID related public health decision making.
Dataset: Covid-19 Testing Results
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
111 Online
111 Telephony (Aggregate (small numbers supressed)) (Secondary Uses) — Department of Health and Social Care...
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To support scenario modelling as part of the Test, Track and Trace programme. The intention is to see how baseline levels of demand change with COVID-19 as this may influence demand for tests when individuals are in lockdown. — IG-01504
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 08/12/2020
Purpose for which the data is being used: To support scenario modelling as part of the Test, Track and Trace programme. The intention is to see how baseline levels of demand change with COVID-19 as this may influence demand for tests when individuals are in lockdown.
Dataset: 111 Online 111 Telephony
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Demographic and Child Protection Order (CPO) data extracted from the national CP-IS system. (Identifiable) (Direct Care) — West London NHS Trust ...
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Data will be used by healthcare professionals to promote and safeguard the welfare of children with a statutory protection plan during the period of heightened risk resulting from the Covid-19 pandemic. — IG-00294_2
Recipient Data Controller Organisation(s) : West London NHS Trust Sheffield Teaching Hospitals NHS Foundation Trust Guy's and St Thomas' NHS Foundation Trust Walsall Healthcare NHS Trust
Approval Date: 13/12/2020
Purpose for which the data is being used: Data will be used by healthcare professionals to promote and safeguard the welfare of children with a statutory protection plan during the period of heightened risk resulting from the Covid-19 pandemic.
Dataset: Demographic and Child Protection Order (CPO) data extracted from the national CP-IS system.
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: Health and Social Care Act 2012 section 261(4)
Common Law Duty of Confidentiality: Health and Social Care Act 2012 section 261(4)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: Childrens Act 2004 s11
Common Law Duty of Confidentiality: Childrens Act 2004 s11
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Demographics
Second Generation Surveillance System (SGSS)
Shielded Patient List (SPL) (Identifiable) (Direct Care) — COVID Oximetry @home Service Providers*...
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To allow CO@H Providers to identify and refer eligible patients on to the COVID Oximetry @home pathway. — IG-00804_3
Recipient Data Controller Organisation(s) : COVID Oximetry @home Service Providers* *Providers are CCGs or health service providers commissioned by CCGs and will include Trusts, GPs and Community Services.
Approval Date: 10/12/2020
Purpose for which the data is being used: To allow CO@H Providers to identify and refer eligible patients on to the COVID Oximetry @home pathway.
Dataset: Demographics Second Generation Surveillance System (SGSS) Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Shielded Patient List (SPL) (Identifiable) (Direct Care) — NHS England...
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The data will be used for reporting in order to inform the management of the COVID vaccine including linking with vaccination data. — IG-00497_2
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 16/12/2020
Purpose for which the data is being used: The data will be used for reporting in order to inform the management of the COVID vaccine including linking with vaccination data.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides. It would not be within the public interest to apply the National Data Opt Out because of the importance to public health.
Source -
COVID-19 SitReps (Aggregate (small numbers supressed)) (Secondary Uses) — NHS England...
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To understand the clinical need for new long Covid assessment services in terms of numbers of patients seen, the diagnostic tests the services require, and the demographics of the patients who attend so that future provision for patients can be made, and an assessment can be made of unmet need. — IG-00522_4
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 10/12/2020
Purpose for which the data is being used: To understand the clinical need for new long Covid assessment services in terms of numbers of patients seen, the diagnostic tests the services require, and the demographics of the patients who attend so that future provision for patients can be made, and an assessment can be made of unmet need.
Dataset: COVID-19 SitReps
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
A Retrospective Observational Cohort Study Describing Epidemiology, Patient Characteristics, Treatment Patterns and The Potential Burden Of Inhaled Short Acting Beta-2 Agonist (SABA) Over-prescription And Inhaled Corticosteroids (ICS) Under-prescription A — Ekaterina Maslova ...
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A Retrospective Observational Cohort Study Describing Epidemiology, Patient Characteristics, Treatment Patterns and The Potential Burden Of Inhaled Short Acting Beta-2 Agonist (SABA) Over-prescription And Inhaled Corticosteroids (ICS) Under-prescription A
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
Ekaterina Maslova - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Jennifer Quint - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Constantinos Kallis - Collaborator - Imperial College London
Graham Roberts - Collaborator - University of Southampton
Ian Sinha - Collaborator - Alder Hey Childrenâs NHS Foundation Trust
Ralf van der Valk - Collaborator - Astra Zeneca Ltd - UK Headquarters
Sofie Arnetorp - Collaborator - Astra Zeneca R&D Molndal Sweden
Trung Tran - Collaborator - Astra Zeneca Inc - USAOutcomes:
Incidence; prevalence; treatment patterns; exacerbations; health resource utilisation; mortality; costs; total CO2 emission
Description: Technical Summary
Firstly, we will describe the current asthma population in England in people aged 4-17 in terms of SABA and ICS prescriptions, and the temporal patterns seen during the study period. Patients will be categorised according to their SABA and ICS use in terms of British asthma guidelines and Global Initiative for Asthma (GINA) guidelines. Next we will use a cohort study design to compare the effects of different patterns of SABA prescriptions on health outcomes (main outcome will be exacerbations; using Cox models) and healthcare resource utilisation (main outcome will be GP visits; using Poisson or negative binomial models, depending on distribution) (dataset will be all eligible current asthma patients in CPRD aged 4-17 eligible for linkage with HES-ONS). SABA prescriptions will be the main exposure, derived from 6 months of prescription data before the study start; the categories used will depend on the findings of the descriptive analysis. Models will be adjusted for multiple potential confounders, in particular ICS prescriptions. If the descriptive analysis shows patients change between SABA or ICS categories over time then this will be taken into account; firstly the regression models will censor patients once they change to a different exposure category, secondly, in sensitivity analyses we will use extensions to the regression models to take into account the time-varying exposures. If numbers allow we will investigate mortality as an outcome. We will also determine total costs (healthcare and environmental (CO2 emission) ). We will explore the use of other asthma treatments (leukotriene receptor antagonists (LTRA) and oral corticosteroids. We will also include co-existing conditions (allergies, asthma phenotypes, depression) in the models as appropriate.
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Weight change and cardio-metabolic outcomes in people with a serious mental illness in the UK from 1998 to 2020: a cohort study using the CPRD database — Paul Aveyard ...
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Weight change and cardio-metabolic outcomes in people with a serious mental illness in the UK from 1998 to 2020: a cohort study using the CPRD database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-18
Organisations:
Paul Aveyard - Chief Investigator - University of Oxford
Charlotte Lee - Corresponding Applicant - University of Oxford
Carmen Piernas - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Felicity Waite - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Min Gao - Collaborator - University of OxfordOutcomes:
Update 2021-11-19: All objectives remain the same. We have only amended this section to make clear that our outcomes are absolute mean change in weight (objective 1) and absolute mean change in biomarkers for CVD risk (objective 2).
Objectives 1, 2 and 4 are descriptive and we will run separate analyses for each outcome. Objective 3 is hypothesis testing of our primary outcome. We will interpret the data based on the associations seen for all outcomes by looking for consistency and interpretable patterns. The outcomes for each objective are as follows:
Objective 1: Examine the prospective association between SMI status and mean weight change from index date* until censored**.
Outcome(s): Absolute mean change in weight (kg), percentage weight (kg) and body mass index (BMI).
Objective 2: Examine the prospective association between SMI status and biomarkers of CVD risk from index date until censored.
Outcome(s): absolute mean change in biomarkers for CVD risk: mean total-cholesterol, low-density lipoprotein (LDL), triglycerides, fasting plasma glucose (FPG), glycated haemoglobin (HbA1c,) and blood pressure (systolic and diastolic).
Objective 3: Examine the prospective association between SMI status and incidence of CVD and CVD fatalities from index date until censored.
Outcome: Total incident CVD: angina, coronary heart disease, congestive heart failure or cardiomyopathy, total stroke, and total fatal CVD events.
Objective 4: Compare incidence of offer and actual referral to weight management services in people with SMIs and obesity (BMI â¥30 kg/m2) with controls without SMIs but with obesity from index date until censored.
Outcome(s): Proportion (%) of exposed and unexposed who are recorded as offered and actually referred to weight management services.
* Further details on index date are provided in section K.
** Further details on censored date are provided in section K.Description: Technical Summary
Meta-analyses of observational studies suggest people with serious mental illness (SMI) have a significant increased incidence of cardiovascular disease (CVD) and CVD-related mortality compared with the general population. Excess weight and related comorbidities are preventable risk factors for CVD. Other evidence suggests that people with SMI are 2 to 3 times more likely to have excess weight, perhaps due to medications and modifiable behaviours, but long-term data are scarce.
Since weight is modifiable, UK clinical guidelines recommend anyone with excess weight is offered a referral to a weight management service by their general practitioner (GP). However, no study has examined the proportion of people with SMI and excess weight who are offered and referred to these services.
In this retrospective cohort study, we will link general practice records from the UK Clinical Practice Research Datalink database with the Hospital Episode Statistics and Office for National Statistics databases. We will establish a cohort of patients diagnosed with SMI between 1998 and 2020 matched with four controls on age, sex, GP practice and calendar year. We will establish a sub-cohort to include patients with obesity (BMI â¥30 kg/m2). Our objectives are to:
1. Examine the prospective association between SMI and mean weight change;
2. Examine the prospective association between SMI and biomarkers of CVD risk;
3. Examine the prospective association between SMI and incidence of CVD and CVD fatalities;
4. Compare incidence of offer and actual referral to weight management services in people with both SMI and obesity with controls.We will use a representative population sample to provide the first examination of the long-term association between SMI and weight, CVD risk factors and CVD outcome. We aim to provide the evidence necessary to allow healthcare providers and policy makers to more effectively manage excess weight in this underserved group.
Source - and 26 more projects — click to show
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The impact of painful musculoskeletal conditions on management and outcomes of cancer: a linked electronic health record study — Kelvin Jordan ...
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The impact of painful musculoskeletal conditions on management and outcomes of cancer: a linked electronic health record study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-02
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Alyson Huntley - Collaborator - University of Bristol
Christian Mallen - Collaborator - Keele University
Felix Achana - Collaborator - University of Oxford
James Bailey - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Kayleigh Mason - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Martin Frisher - Collaborator - Keele University
May Ee Png - Collaborator - University of Oxford
Michelle Marshall - Collaborator - Keele University
Neil Heron - Collaborator - Keele University
Simon White - Collaborator - Keele University
stephen tatton - Collaborator - Keele UniversityOutcomes:
1: Admission to hospital (for cancer and for any reason);
2: Length of stay in hospital;
3. Readmission to hospital within 30 days of discharge (for same or for different reason as initial admission);
4. Time to mortality;
5: Time to palliative care;
6: Provision of chemotherapy and radiotherapy, prescription of hormone modulation treatment for breast cancer and anti-androgen hormone therapy for prostate cancer;
7. Cumulative health care use and costs over 5 years after index date. Primary care data will include number and type of consultation with each health care professional, prescriptions, tests and investigations. Secondary care utilisation includes referral, type of admission, length of stay, diagnosis, and procedures undertaken.Description: Technical Summary
Cancer is life-threatening, affects quality of life, is a common reason for going to hospital, and is of high NHS priority. In people with long-term conditions, such as cancer, musculoskeletal pain is common but often neglected. Musculoskeletal comorbidity may impact on outcomes if pain (and associated restricted functioning and sleep interference) prevents or delays delivery of appropriate treatment or reduces its effectiveness. It may limit patientsâ ability to manage other conditions at home, increasing likelihood of hospitalisation, extending time to discharge, and worsening outcomes.
We aim to understand the extent of association between pre-existing musculoskeletal conditions and outcomes for patients with cancer, including time to hospital admission (for any reason) and long-term outcomes. We will analyse data of patients newly diagnosed with cancer and compare patients with a prior painful musculoskeletal condition requiring health care to patients without such a condition on rates of hospital admission, length of hospital stay, 30-day readmission, mortality, need for palliative care, and resource use and costs. Painful musculoskeletal conditions will be identified from primary care records in the 24-months prior to cancer diagnosis. We will compare hospital admission and readmission rates and long-term outcomes between those with and those without musculoskeletal comorbidity. Flexible parametric survival models will be used to model time to hospitalisation, mortality, and palliative care. Poisson regression will be used to determine differences in length of stay in hospital. We will include in further models proxies for pain severity (musculoskeletal referral, analgesia prescription). We will account for clustering by practice. Our findings will allow assessment of the potential for existing evidence-based management of musculoskeletal pain and associated disability to be targeted in these patients to make a substantial impact on outcomes of cancer diagnoses.
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The SPECTRUM Study - Stratifying phenotypes in Chronic Obstructive Pulmonary Disease: An observational study of treatment allocations using the updated National Institute fie Health and Care Excellence recommendations in England — Jay Were ...
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The SPECTRUM Study - Stratifying phenotypes in Chronic Obstructive Pulmonary Disease: An observational study of treatment allocations using the updated National Institute fie Health and Care Excellence recommendations in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-02
Organisations:
Jay Were - Chief Investigator - Health iQ
Jay Were - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Elisa Tacconi - Collaborator - Not from an Organisation
Gulsah Akin Unal - Collaborator - Health iQ
Judith Ruzangi - Collaborator - Health iQ
Mico Hamlyn - Collaborator - Health iQ
Shea O'Connell - Collaborator - Health iQ
Smit Patel - Collaborator - Boehringer-Ingelheim International GmbHOutcomes:
Prevalence of COPD; Prevalence of COPD by asthmatic features and steroid responsiveness; Demographics (Mean and median age on inclusion, percent males, total, mean and median follow-up and geographical region); Clinical characteristics (BMI, Charlson co-monidity score, lung function, smoking status, history of vaccinations, frequency of exacerbations); treatment pathway(prescriptions issued in primary care, number of patients needing renal replacement therapy receiving haemodialysis, peritoneal dialysis, hemodiafiltration and transplantation); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality, referrals, COPD assessment scores, asthma, atopy, prescriptions in primary care, ashmatic features, steroid responsiveness)
Description: Technical Summary
COPD usually develops because of long-term damage to your lungs from breathing in a harmful substance, usually cigarette smoke, and air pollution due to dust, fumes and chemicals.
Youâre most likely to develop COPD if youâre over 35 and are, or have been, a smoker or had chest problems as a child.
Following a review of the evidence around phenotyping, changes in therapies available and recent clinical reviews, NICE have published updated guidelines to include further evidence related to Long acting beta agonist(LAMA)/ long acting muscarinic antagonists(LABA)/ICS Inhaled corticosteroids(triple therapy).
Considering adherence to clinical guidelines is varied, the updated recommendations by NICE should be evaluated to understand the implications of variable interpretations in clinical practice. Although deviations from NICE guidelines may perhaps be due to adherence to local CCG guidelines on COPD management, this study will not examine this outcome.
This shall be a retrospective cohort study on a clinical healthcare dataset linked to an administrative healthcare dataset. This study shall determine patients that have been diagnosed with COPD and
describe their demographic and clinical characteristics as well as treatment received and healthcare burden and cost.The study will also involve a comparative element with the aim of comparing outcomes between non-asthmatic patients taking ICS containing regimen compared to non-asthmatic patients prescribed non-ICS containing regimen with a null hypothesis that a difference exists within the two cohorts. This will be modelled using a multivariate Cox proportional hazards regression. Kaplan-Meier analysis will be performed to compare time-event-for first pneumonia diagnosis between ICS vs. non-ICS prescribed patients.
The study design has been chosen as it is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for procedures, demographics, costs, complications, readmissions and resource use.
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Distributional and heterogeneous treatment effects of health care interventions for gestational diabetes using regression discontinuity in electronic health record data — Till Bärnighausen ...
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Distributional and heterogeneous treatment effects of health care interventions for gestational diabetes using regression discontinuity in electronic health record data
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-09
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Maike Hohberg - Corresponding Applicant - University Hospital Heidelberg
Anant Jani - Collaborator - University of Oxford
Anuradhaa Subramanian - Collaborator - University of Birmingham
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
Child outcomes: birth weight, gestational age at birth, size for gestational age, macrosomia, mortality, Apgar score, need for respiratory support, still birth/neonatal death, birth trauma (e.g. shoulder dystocia, fracture of humerus or clavicle, brachial plexus injury), neonatal hypoglycaemia, neonatal hyperbilirubinaemia, admission to the neonatology department, childhood obesity, childhood diabetes; childhood asthma, poor mental health.
Maternal outcomes: caesarean delivery or other interventions during labour, preeclampsia, plasma glucose and HbA1c levels during pregnancy, post-natal depression, later life outcomes of overweight or obesity, poor mental health, type 2 diabetes and complications (retinopathy, etc.), hypertension, strokes and MIs, renal disease, peripheral vascular disease, all cause mortality, cardiovascular mortality.
Description: Technical Summary
The literature on gestational diabetes uses observational data to study risk factors and outcomes but it has not rigorously analysed the effects interventions such as life style advice or metformin/insulin. On the other hand, clinical trials have investigated the impact of such interventions but are undertaken with a limited time horizon, and only capture pre-specified outcomes. Furthermore, the sample size in clinical trials is often too small to perform adequate subgroup analyses and evaluate heterogeneous treatment effects.
In combination with a regression discontinuity (RD) design, CPRD data allows us to exploit multiple advantages. To establish causality, the RD design takes advantage of the glucose threshold rules set by UK clinical guidelines that recommend gestational diabetes interventions.
Due to the CPRDâs long time horizon and large sample size, we will not only analyse antenatal and perinatal outcomes but will also evaluate postnatal effects of gestational diabetes interventions in different subgroups of patients.
We will evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with glucose levels increasingly close to the treatment threshold level.
Since gestational diabetes intervention may not only affect mean outcomes but also other distributional features such as the variance, we combine the RD design with a distributional regression approach (GAMLSS, Generalized additive models for location, scale and shape) to evaluate the impact on the whole conditional distribution of the outcomes.
The findings of this study are expected to provide novel insights into the effectiveness of gestational diabetes therapy in a real-life setting and can directly inform clinical practice.
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Use and effectiveness of physical activity and dietary based lifestyle interventions for patients with hypertension — Till Bärnighausen ...
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Use and effectiveness of physical activity and dietary based lifestyle interventions for patients with hypertension
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-15
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Maximilian Schuessler - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
We will explore the effects on the following primary outcomes:
- Blood pressure
- Blood cholesterol levels (HDL, LDL, total cholesterol)
- BMI
- Smoking status
- Recorded hazardous alcohol consumptionWe will also explore the following secondary outcomes
- Number of all-cause emergency hospitalizations
- Number of cardiovascular disease-related emergency hospitalizations
- Number of severe adverse health events (stroke, heart attack [myocardial infarction] â each event type evaluated separately)
- All-cause mortality
- Number of GP visits
- Number of medicationsDescription: Technical Summary
This is an observational cohort study that focuses on the patterns of use and effectiveness of lifestyle intervention programmes in UK primary care. First, this study explores the use of lifestyle interventions in UK primary care in adherence to current guidelines for hypertension, for which they are recommended as a first line option, by studying the proportion of patients who received a structured lifestyle intervention upon their diagnosis of hypertension. Second, we aim to analyze the effect of lifestyle intervention on physical and behavioral outcomes in a routine care set-up for adult men and women. We will divide the lifestyle interventions into different subgroups (i.e. physical activity-based, dietary, or pharmaceutical interventions) and will examine the effects of each intervention and each combination of interventions separately on our outcomes (i.e., blood pressure, blood cholesterol levels, BMI, smoking, hazardous alcohol consumption, mortality [by linkage to Office for National Statistics data], number of hospitalizations [by linkage to Hospital Episode Statistics data] and severe adverse health events recorded; at each follow-up time of 6 months, 1, 3, or 5 years). We aim to apply the DAME (Dynamic Almost Matching Exactly) matching approach, an advanced matching technique that weighs those covariates more which directly contribute towards the treatment effect more. Upon matching our treatment and control groups and to determine whether outcomes of patients differ between patients in each subgroup, we will apply mean comparison tests. Finally, we will test for heterogenous treatment effects by stratifying our sample by sex, age, socioeconomic status, ethnicity and comorbidities. Multiple testing is accounted for using the Benjamini-Hochberg method to take into consideration the number of subgroups and primary outcomes. The findings of this study are expected to provide novel insights into the use and effectiveness of lifestyle interventions in a real-life setting and can directly inform clinical practice.
Source -
Prevalence, incidence, healthcare resource utilization and costs of myotubular myopathy patients in England — Amit Kiran ...
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Prevalence, incidence, healthcare resource utilization and costs of myotubular myopathy patients in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-18
Organisations:
Amit Kiran - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Asad Khan - Collaborator - Astellas Pharma Europe Ltd. - UK
Bas van der Poel - Collaborator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Collaborator - Astellas Pharma Europe Ltd. - UKOutcomes:
MTM cases (for prevalence and incidence calculations); Healthcare resource use including number of GP visits, hospital outpatient visits, inpatient admissions, A&E visits, diagnostic tests, procedures, and length of stay in hospital; Costs for healthcare resource use; All-cause mortality and cause-specific mortality.
Description: Technical Summary
Myotubular myopathy (MTM) is an X-linked monogenic disorder characterized by profound skeletal muscle weakness, impaired motor function, severe respiratory failure and death. It is caused by mutations in the MTM1 gene which results in deficiencies in myotubularin and disrupts normal development, maintenance and function of skeletal muscle. It occurs almost entirely in males and in its most severe form 50% of babies will die in their first year of life. Those who survive are likely to be dependent on ventilator support; most patients never achieve ambulation.
There has been limited reporting on the real world epidemiology and management of patients with MTM, in part due to the rarity of the disorder.
This study aims to provide foundational insights on the prevalence, incidence, health care resource use (HCRU), associated costs, and mortality of males with MTM. Cases will be identified using diagnosis codes , and will be described in terms of their patient characteristics and a-priori comorbidities. The prevalence and incidence rate of MTM among the general population of males will be estimated. The HCRU of MTM cases will include a reporting of resource use in primary care, outpatient setting, inpatient setting and A&E. We will estimate associated costs of HCRU. Mortality of MTM cases will also be described.
This is a descriptive study using the most recent 20 years of linked electronic medical records in England.
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Temporal trends in arthroscopic subacromial decompression during and after conduct of a large UK multi-centre trial — Daniel Prieto...
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Temporal trends in arthroscopic subacromial decompression during and after conduct of a large UK multi-centre trial
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-02
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
James Smith - Corresponding Applicant - University of OxfordOutcomes:
Temporal trends in ASAD incidence rates and characteristics patients undergoing the procedure.
Description: Technical Summary
This is a descriptive study examining temporal trends in arthroscopic subacromial decompression (ASAD) for subacromial pain. We want to determine whether there has been a change in clinical practice in response to the conduct (from 2012 to 2015) and publication (in 2017) of a large UK trial finding that subacromial decompression is unlikely to be effective.
OBJECTIVES
1. Temporal analysis of incidence rates of ASAD
2. Temporal analysis of characteristics of patients undergoing ASADMETHODS
Data sources: CPRD GOLD. We are replicating this study in similar primary care databases internationally, and are not requesting HES linkage for comparability.Participants: Incidence rates: all CPRD patients; patient characteristics: patients undergoing ASAD
Outcomes: ASAD
Measurements: Counts of subacromial decompression surgery and all patient characteristics listed in âcovariatesâ (Section M)
Statistics: Incidence rates will be calculated as the proportion of the population registered in any contributing practice in a given calendar year who undergo ASAD for the first time in their records in that same year. Stratified rates will be obtained by sex and age groups.
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Assessment of the burden of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D) in England — Jennifer Quint ...
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Assessment of the burden of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D) in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
- Corresponding Applicant -
Julie Broughton - Collaborator - Bayer AG
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Niklas Schmedt - Collaborator - Bayer AG
Philip Kalra - Collaborator - Salford Royal Hospital NHS Foundation
Outcomes: Prevalence of CKD in T2D population
Incidence and cumulative incidence of cardiovascular/renal complications and side-effects of MRA useDescription: Lay Summary
Chronic Kidney Disease (CKD) is defined as a progressive, irreversible loss of kidney function that usually happens gradually over years. Patients with CKD commonly have other chronic conditions as well, including type-2 diabetes (T2D) and cardiovascular diseases. Having both CKD and T2D greatly increases ill-health and mortality of patients. There is little information about the real-world characteristics and management of patients with both CKD and T2D in England. This study addresses this data gap by collecting data on the characteristics, treatment, and outcomes for patients with both CKD and T2D in England.
Technical SummaryThis study is aimed at determining the burden of chronic kidney disease (CKD) in the type-2 diabetes population of England including prevalence, treatment patterns, and occurrence of cardiovascular and renal complications. Prevalence of CKD in the T2D population of England will be determined at seven cross-sectional time points, at six month intervals, from January 2017 to December 2019. Demographics, cardiovascular and renal medication use, and history of CKD investigations will be assessed in each cohort from each of the seven time points. Additionally, a cohort study covering the entire period from January 2017 to December 2019 will be assessed for the occurrence of cardiovascular and renal complications and for the occurrence of side effects related to treatment with mineralocorticoid receptor antagonist (MRA). Incidence of these events will be determined using Poisson regression and cumulative incidence using Kaplan-Meier curves. These outcomes will be assessed in the CKD-T2D population and in a number of subgroups, including patients meeting specific inclusion/exclusion criteria related to their CKD and those patients with a history of cardiovascular disease, taking specific cardiovascular or renal medications, a chronic respiratory diseases.
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Effectiveness and cost-effectiveness of alcohol use screening tests and treatments for alcohol-use disorders — Jim Lewsey ...
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Effectiveness and cost-effectiveness of alcohol use screening tests and treatments for alcohol-use disorders
Datasets:GP data, HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
Jim Lewsey - Chief Investigator - University of Glasgow
Jim Lewsey - Corresponding Applicant - University of Glasgow
Bhautesh Jani - Collaborator - University of Glasgow
Claudia Geue - Collaborator - University of Glasgow
Eileen Kaner - Collaborator - University Of Newcastle Upon Tyne
Elise Whitley - Collaborator - University of Glasgow
Francesco Manca - Collaborator - University of Glasgow
Frederick Ho - Collaborator - University of Glasgow
Janet Bouttell - Collaborator - University of Glasgow
Linsay Gray - Collaborator - University of Glasgow
Lisong Zhang - Collaborator - University of Glasgow
Srinivasa Vittal Katikireddi - Collaborator - University of GlasgowOutcomes:
⢠Primary care record of alcohol use disorder (a. identified by AUDIT PC > 4; b. identified by AUDIT C > 4; c. identified by AUDIT C > 10; d. identified by FAST > 2; e. identified by âSingle question alcohol use testâ (M-SASQ) > 1)
⢠Hospitalisation for alcohol intoxication / harmful use (AIH)
⢠Hospitalisation for alcohol dependency (AD)
⢠Hospitalisation for alcoholic liver disease
⢠Hospitalisation for liver disease (all)
⢠Death (caused by AIH)
⢠Death (caused by AD)
⢠Death (caused by alcoholic liver disease)
⢠Death (caused by liver disease â all)
⢠Death (all cause)Note: the rationale for using alcohol use disorders (intoxication / harmful use / dependency) and alcoholic liver disease is that they make up a quarter of alcohol-attributable mortality, and are 100% alcohol attributable [1]
For developing the decision analytic model, we require linked data to all hospitalisation records.
Description: Technical Summary
In this cohort study we will ascertain two cohorts of individuals and follow them up to quantify risk of future outcomes (primary care visits, hospitalisations and deaths) and to estimate remaining (quality adjusted) life expectancy.
Cohorts:
Cohort 1 (secondary prevention population): individuals at risk of alcohol harm (defined by screening tests such as AUDIT and FAST; self-reported âhighâ level of alcohol consumption; other alcohol consumption related Read/Snomed codes)Cohort 2 (tertiary prevention population): individuals hospitalised for any alcohol related condition (defined by ICD codes)
Screening test / treatment variables:
Alcohol use screening tests; Alcohol brief interventions; Pharmacological interventions (e.g. Acamprosate, Disulfiram, Nalmefene, Naltroxone)Outcome variables:
Primary care record of alcohol use disorder; hospitalisations (alcohol intoxication / harmful use; alcohol dependency; alcoholic liver disease; liver disease (all)) and deaths (same categories as hospitalisations and all cause deaths)Other variables (not mentioned above):
Patientâs age, patientâs sex, socio-economic deprivation (area-based), lab test results, comorbidity measured by Read/Snomed/ICD codes (e.g Charlson index)Statistical methods:
Comparative effectiveness analyses for head-to-head comparisons of screening tests, alcohol brief interventions and pharmacological interventions will be carried out using multivariable logistic/Cox regressions, propensity score adjusted logistic/Cox regressions and instrumental variables adjusted logistic/Cox regressions. The latter will use physicianâs prescribing preferences and general practice preferences as instruments.Decision analytic model / economic evaluation tool:
The outcomes from the statistical analyses will be used to populate a decision analytic model which will extrapolate the outcomes for the cohorts ascertained above using parametric survival modelling, validating against external data sources (e.g. national life tables). The different cohorts will allow economic evaluation of âsecondaryâ and âtertiaryâ prevention strategies.Sensitivity analyses:
As uncertainty exists in all aspects above, pre-specified sensitivity analyses will be undertaken.
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Women's preconception health in General Practice: Understanding how women interact with GP services prior to becoming pregnant, and the impact of preconception health on pregnancy outcomes for women and babies — Claire Carson ...
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Women's preconception health in General Practice: Understanding how women interact with GP services prior to becoming pregnant, and the impact of preconception health on pregnancy outcomes for women and babies
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-04
Organisations:
Claire Carson - Chief Investigator - University of Oxford
Claire Carson - Corresponding Applicant - University of Oxford
Dimitrios Siassakos - Collaborator - University College London ( UCL )
Fiona Alderdice - Collaborator - University of Oxford
Helen Campbell - Collaborator - University of Oxford
Jenny Kurinczuk - Collaborator - University of Oxford
Julia Sanders - Collaborator - Cardiff University
Maria Quigley - Collaborator - University of Oxford
Oliver Rivero-Arias - Collaborator - University of Oxford
Sara Kenyon - Collaborator - University of Birmingham
Svetlana Ratushnyak - Collaborator - Nuffield Department of Population Health
Yangmei Li - Collaborator - University of OxfordOutcomes:
This is a staged analysis:
For Stage 1: the analysis is descriptive.
For Stage 2: outcomes that have a substantial impact on maternal and infant health have been selected based on evidence from literature, such as the MBRRACE-UK reports of national confidential enquiries into maternal deaths and morbidity,1-4 and include the three categories as follows. Depending on the quality of the data, we may not be able to analyse some outcomes if the prevalence estimated from our data is considered to be unreliable after being checked against published estimates. Examples of outcomes in each group are provided:
i) Pregnancy outcome: recorded termination of pregnancy, pregnancy loss (miscarriage, stillbirth). Note that CPRD pregnancy register has a proportion of pregnancies classified as unknown outcome, we may need to treat these as a group in their own right.
ii) Maternal outcomes: hypertension in pregnancy, (pre)-eclampsia, gestational diabetes, induction of labour, mode of birth, sphincter injury, duration of postnatal hospital stay, postpartum incontinence, painful intercourse and perineal or pelvic pain, wound problems and infection, postpartum mental health conditions.
iii) Neonatal and infant outcomes
Preterm birth (gestational age at birth <37 weeks), small for gestational age, low birthweight (birthweight <2500 grams), very low birthweight (birthweight <1500 grams), macrosomia (birthweight >4000 grams), birth injuries and fracture including shoulder dystocia, and neonatal resuscitation. We may define a âcompositeâ neonatal/infant outcome for serious morbidity/mortality outcomes with small numbers of events.For Stage 3: maternal and baby health care resource use and costs associated with different forms of pre-pregnancy care or without pre-pregnancy care will be estimated from an NHS perspective. A cost-effectiveness analysis over the study period will be conducted to demonstrate value for money of pre-pregnancy care expressed as cost per adverse event averted.
Description: Technical Summary
The aim of this study is to examine the impact of good pre-pregnancy health and care on outcomes for women and their children.
Stage 1: First, it is necessary to understand the characteristics of women registered with a GP and to explore how they engage with their GP. Women of reproductive age (18-48yrs) will be studied over a 2 year period (2017-2018) prospectively, and their demographic characteristics, lifestyle factors, and pre-existing conditions described. Engagement with GP services will be described in terms of number and type of consultations. Diagnostic, symptom and therapy codes, plus health prevention entity types relating to preventative health advice, pre-pregnancy care, pregnancy advice or fertility concerns will be extracted to explore the feasibility of identifying specific pre-pregnancy care.
Stage 2: Next, we will focus on women who became pregnant, to assess the effects of pre-pregnancy health on selected maternal and infant outcomes. Examples of outcomes for women include pregnancy loss, gestational diabetes, pre-eclampsia, and postpartum mental health conditions, while examples of baby outcomes include gestational age at birth, birthweight, birth injuries and other serious neonatal morbidity. Regression methods will be used to explore the association between sociodemographic and lifestyle factors, pre-existing morbidity, poor pregnancy history and outcomes of interest. We will examine how receipt of pre-pregnancy care in the year prior to pregnancy affects the outcomes. Population attributable fractions will be estimated for different aspects of poor pre-pregnancy health.
Stage 3: Finally, an economic evaluation will be conducted to estimate potential NHS costs and outcome differences between women receiving different pre-pregnancy care. Costs will be estimated from an NHS perspective and will include a thorough account of primary and secondary care in both groups. The outcome measure of the economic evaluation will be subsequent adverse events averted between women receiving and not receiving pre-pregnancy care.
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"A cohort study of mortality in the Clinical Practice Research Datalink (CPRD) primary care database - CPRD Aurum" — Martin Gulliford ...
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"A cohort study of mortality in the Clinical Practice Research Datalink (CPRD) primary care database - CPRD Aurum"
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-15
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Emma Rezel-Potts - Collaborator - King's College London (KCL)Outcomes:
All-cause mortality based on the CPRD death date in CPRD Aurum.
Description: Technical Summary
This study aims to explore all-cause mortality in CPRD Aurum. The specific objectives are: i) to compare mortality rates between CPRD Aurum and published mortality rates from national registration data in England and Wales and Scotland; ii) to evaluate trends in mortality taking into account age, calendar year and year of birth; iii) to conduct an interrupted time series analysis to estimate the excess mortality associated with Covid19; and iv) to evaluate the extent of variations in mortality among general practices taking into account region, ethnicity, deprivation, comorbidity, influenza, Covid19 and preventive medical interventions. A cohort study will be conducted in CPRD Aurum using data for person time and deaths from any cause that are aggregated across general practices, age-groups, gender and calendar year. We will also analyse aggregated data for proportion of population coded as of black or minority ethnic origins, having morbidities including malignant neoplasms, cardiovascular diseases, respiratory diseases, metabolic diseases (including diabetes) and dementia, proportion of practice population treated with antihypertensive drugs or statins, and annual incidences of influenza and Covid-19. Mortality rates will be compared with national registration data. Trends over time and variation among general practices will be evaluated from hierarchical Poisson regression models. An interrupted times series analysis will be used to evaluate the impact of the pandemic. Variation among practices will be evaluated from the distribution of random effects. The analyses will evaluate how CPRD Aurum data can be used to evaluate mortality trends. The analyses will also contribute to understanding recent changes in mortality including excess mortality form Covid-19.
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Statin use to mitigate the unwarranted cardiovascular side effects of non-steroidal anti-inflammatory drugs: A population-based case control study — Jennifer Quint ...
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Statin use to mitigate the unwarranted cardiovascular side effects of non-steroidal anti-inflammatory drugs: A population-based case control study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-18
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ricky Vaja - Corresponding Applicant - Imperial College London
Jane Mitchell - Collaborator - Imperial College London
Laura Portas - Collaborator - Imperial College London
Nicholas Kirkby - Collaborator - Imperial College London
Plinio Ferreira - Collaborator - Imperial College LondonOutcomes:
Myocardial infarction which will include STEMI, NSTEMI and Acute coronary syndromes as a composite outcome and if numbers allow individually.
Stroke which will include ischaemic and haemorrhagic but not TIA given the inaccuracy of recording of TIA events. Codes will be used according to the stroke validation study undertaken (Morgan et al Br J GP 2020).
We will identify these outcomes in HES and ONS so death by these causes will be included. If numbers allow we will look at mortality separately as an outcome.
Description: Technical Summary
Non-steroidal anti-inflammatory drugs (NSAIDs) which include ibuprofen, naproxen and celecoxib, are amongst the most commonly used medications world-wide to treat fever, pain and inflammation. With the exception of aspirin, all NSAIDs carry a significant risk of heart attacks and strokes which has led to increased anxiety amongst physicians and patients and the withdrawal of celecoxib as a preventive treatment for colon cancer.
Despite the widespread use of NSAIDs, we currently do not know:
1) If NSAID use is an independent risk factor of cardiovascular disease.
2) Enough about what groups of patients have the highest risk.
3) If there are any treatments to reduce the risk.Our objective is to identify risk factors that might predict cardiovascular events in patients who take NSAIDs. We want to assess whether cardio-protective drugs including statins or aspirin may be protective against additional cardiovascular disease associated with NSAID use. Our study will be split into three stages:
Stage 1: To identify whether NSAID use is an independent risk factor for cardiovascular disease we will use a matched case control study to identify predictors of cardiovascular disease (myocardial infarctions and strokes (excluding TIAs) using conditional logistic regression.
Stage 2: To identify what group of NSAID users are at the highest risk of a cardiovascular event we will identify risk factors for myocardial infarction or stroke in NSAID users using time to event data. We will use cox-regression. We hope this could allow clinicians to risk stratify patients who require longer-term NSAID use.
Stage 3: We will assess if aspirin or statin use as a secondary preventative measure can offset the additional cardiovascular risk associated with NSAID use, again using Cox regression.
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Producing epidemiologic estimates by cancer type in England: A cohort study using linked primary care to secondary data sources — George Kafatos ...
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Producing epidemiologic estimates by cancer type in England: A cohort study using linked primary care to secondary data sources
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; No additional NCRAS data required; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
George Kafatos - Chief Investigator - Amgen Ltd
Olga Archangelidi - Corresponding Applicant - Amgen Ltd
David Neasham - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen LtdOutcomes:
⢠Agreement, sensitivity, specificity, PPV, NPV of cancer diagnoses between CPRD Aurum and combination of HES, and CR,
⢠Agreement, sensitivity, specificity, PPV, NPV of cancer diagnoses between CPRD GOLD and combination of HES, and CR,
⢠Agreement, sensitivity, specificity, PPV, NPV of deaths between CPRD Aurum and ONS death registry
⢠Agreement, sensitivity, specificity, PPV, NPV of deaths between CPRD GOLD and ONS death registry,
⢠Incidence,prevalence and mortality rates by cancer type.
⢠A multiplicative adjustment factor to correct potential differences in morbidity parameters estimations by cancer type, gender and age.
⢠Survival probabilities estimatesThe types of cancer for which the epidemiological measures will be estimated are:: multiple myeloma, acute myeloid leukemia, acute lymphoblastic leukemia, lung cancer, melanoma, colorectal cancer, prostate cancer, pancreatic, neuroendocrine, glioblastoma multiforme, gastric cancer, breast cancer, non-Hodgkin lymphoma, head and neck, kidney, bladder, uterus, ovarian, esophagus, and thyroid. A small number of these types has already been explored in the literature so their inclusion here aims to compare these estimates with existing published findings. Additional types will be explored to chosen based on their high frequency in the population, clinical relevancy and further investigation of currently under-explored types.
Description: Technical Summary
Patient demographics and route of diagnosis impact the accuracy of cancer diagnosis in CPRD. To circumvent potential systematic deficiencies and biases in primary care diagnoses records we will use a combination of Cancer Registries and HES as the âgold standard for diagnoses. We will link primary care data (CPRD-GOLD/Aurum) with secondary administrative data sources and Registries (HES/ONS/CR) to estimate potential differences and agreement in cancer cases identification between the data sources. We will then assess diagnosis accuracy markers i.e sensitivity, specificity, positive/negative predicted value), as well as incidence and prevalence of cancers in each one of the sources. Based on these estimations we will then explore the feasibility of calculation of a single correction factors for the different measures of morbidity and diagnostic accuracy and these calculations will be produced for each one of the cancer indications and stratified by gender and age group. These corrected results could potentially be implemented in future CPRD research projects. Finally, survival will be estimated separately by each indication.
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The benefits and side effects of osteoporosis medications: A regression discontinuity study of primary care patients in the UK. — Till Bärnighausen ...
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The benefits and side effects of osteoporosis medications: A regression discontinuity study of primary care patients in the UK.
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-11
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Duy Do - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
Primary outcomes (measured within five years from an index date): future bone density T-scores.
Secondary outcomes (measured within one year, five years, and ten years from an index date): Probability/number of major osteoporosis fracture events (e.g. vertebrae, humerus, wrist, femur, and hip fractures), all-cause mortality, probability of any osteoporosis-related unintended adverse side effects (including but not limited to musculoskeletal pain, osteonecrosis of the jaw, atypical thigh bone fracture, ulcer, and hypocalcemia); probability of at least one hospitalization for osteoporosis-related adverse side effects; number of hospitalizations for osteoporosis-related adverse side effects; probability of at least one all-cause emergency hospitalization; number of all-cause emergency hospitalizations; probability of at least one fracture-related hospitalizations; and number of fracture-related hospitalizations; probability of at least one osteoporosis-related hospitalizations; and number of osteoporosis-related hospitalizations. Other secondary outcomes include future bone density T-scores (measured within one year and ten years from an index date)
Description: Technical Summary
This study seeks to evaluate the benefits and adverse side effects of osteoporosis medications among primary care patients in the UK using the regression discontinuity (RD) method. The RD design can be used to assess the causal effect of osteoporosis medications on health outcomes by taking advantage of a decision rule used to determine patientsâ eligibility for pharmaceutical treatment of osteoporosis. Specifically, we aim to (1) determine whether or not there is a substantial change in the probability of using osteoporosis medications between patients whose T-score for bone mineral density falls just below and above an arbitrary cut-off point as published in major clinical guidelines, (2) evaluate if patient characteristics are balanced within a small bandwidth surrounding the threshold, and (3) investigate whether associations between osteoporosis medications and patient outcomes are robust to different choices of bandwidth around the threshold. Patient outcomes include future bone density T-scores, probability/number of major osteoporosis fracture events, probability of any adverse side effects (e.g. musculoskeletal pain, osteonecrosis of the jaw, atypical thigh bone fracture, ulcer, and hypocalcemia), and all-cause mortality. We hypothesize that the use of osteoporosis medications decreases future T-scores for bone density, the probability/number of fractures, and mortality. We will estimate âfuzzyâ RD models using a local linear regression and triangular weights to avoid overfitting the data and to give more influence to observations close to the threshold. In addition, we will use a mean squared error (MSE) optimal bandwidth that is empirically derived. We assess the sensitivity of the results using alternative bandwidths (e.g. bandwidths that are 50%, 75%, 125%, and 150% of the empirically derived bandwidth). Our findings will provide valuable insights into the real-life effects of osteoporosis medications on health, the unintended effects associated with these medications, and the heterogenous treatment effects by detailed patient subgroups.
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Epidemiology, Natural History and Burden of Disease in Patients with Alpha-1 Antitrypsin Deficiency in the UK: A Real-World Retrospective Cohort Study — Zheng...
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Epidemiology, Natural History and Burden of Disease in Patients with Alpha-1 Antitrypsin Deficiency in the UK: A Real-World Retrospective Cohort Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
Zheng-Yi Zhou - Chief Investigator - Analysis Group, Inc.
Nisha Hazra - Corresponding Applicant - Analysis Group Ltd
Cassie Tang - Collaborator - Analysis Group, Inc.
Riley Taiji - Collaborator - Analysis Group, Inc.Outcomes:
Study outcomes will include prevalence counts and incidence rates for AATD, demographics and background characteristics (e.g. age at index date, sex, smoking status, alcohol status), prevalence of comorbidities (e.g. COPD, bronchiectasis, asthma, emphysema, cirrhosis, jaundice, coronary heart disease, stroke, hypertensive diseases, diabetes mellitus, heart failure, depressive disorder, osteoporosis), tests and referrals from primary care. Additional study outcomes will include frequencies of different treatments (e.g. bronchodilators, mucolytics, corticosteroids, pulmonary rehabilitation, smoking cessation therapy) for AATD, and mortality rates. Through linking CPRD with HES Admitted Patient Care (APC), Outpatient (OP) and Accident & Emergency (A&E) data, frequency of lung/liver transplants, lung volume reduction surgery and health care utilisation will be measured.
Description: Technical Summary
AATD is a rare inherited disorder and may cause serious lung disease, (i.e. emphysema or COPD), liver disease, or skin rashes. Limited data exists regarding disease burden in AATD patients. This study aims to evaluate the epidemiology, comorbidities, treatment patterns, testing and referrals, mortality and health care utilisation associated with AATD in the UK between 1990 and 2020. AATD patients will be selected using validated Read codes indicative of an AATD diagnosis or an ICD-10 diagnosis code in HES. A non-AATD COPD-control cohort will be selected for comparisons using 1:1 exact matching based on age at index, sex, general practice, and index year. Statistical analysis will be primarily descriptive, consisting of mean, median and standard deviation for continuous variables, and frequency counts and percentages for categorical variables. For comparative analyses, differences between AATD patients and COPD controls will be evaluated using a Wilcoxon signed rank test for continuous variables and McNemarâs tests for categorical variables. Treatment patterns will be described as frequencies in the first, second and third years following diagnosis. Health care utilisation will be evaluated as the proportion of patients with each type of resource use in primary and secondary care and utilisation rates per person year. Mortality rates will be estimated in a time-to-event framework using Kaplan-Meier survival analysis and comparisons between AATD and COPD cohorts will be made using a log-rank test. Hazard ratios will be estimated using a Cox proportional hazards model and the proportional hazards assumption will be tested. Epidemiological results will be stratified by age-group (e.g. <12 years, 13-17 years, <18 years, 18+ years), sex and time period (e.g. 1990-1999, 2000-2009, 2010-2019). The study will generate new evidence regarding the epidemiology and natural history of AATD, based on primary care data representative of the UK population.
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The use of methylphenidate and the risk of suicide attempt: A population-based self-controlled case series study — Kenneth Man ...
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The use of methylphenidate and the risk of suicide attempt: A population-based self-controlled case series study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-18
Organisations:
Kenneth Man - Chief Investigator - University College London ( UCL )
Kenneth Man - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - UCL School Of Pharmacy
Li Wei - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )Outcomes:
Suicide attempt
Description: Technical Summary
We will conduct a population-based self-controlled case series study including all individuals aged â¥6 years who received at least 1 prescription for ADHD medication in the CPRD database between January 1, 1995 to December 31, 2020. Our objective will be to compare the risk of suicide attempt among patients treated with ADHD medication in periods of exposure to ADHD medication versus unexposed periods. Participants who were continuously exposed to the drug will contribute to consecutive exposure risk periods. We will determine the duration of exposure in the study period and calculate incidence rates for suicide attempt events in each of the exposure risk periods. In our analysis, we will estimate the incidence rate ratios of our outcomes using conditional Poisson regression. We will estimate the adjusted IRRs and their 95% confidence intervals for exposure overall and for each predetermined exposure risk periods.
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European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke and all-cause mortality for romosozumab by the EU-ADR Alliance — Alireza Moayyeri ...
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European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke and all-cause mortality for romosozumab by the EU-ADR Alliance
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-08
Organisations:
Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Annika Jodicke - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Chao Lu - Collaborator - UCB BioSciences, Inc.
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Maria Sanchez - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Primary: MACE-2 (first occurrence of death [all cause including cardiovascular (CV) death], myocardial infarction (MI), or stroke)
Secondary: MI; Stroke; Death due to CV causes, i.e., MI or stroke; All-cause mortality; MACE-1 (First occurrence of death (CV causes), MI, or stroke), cardiac arrhythmias and atrial fibrillation.Description: Technical Summary
Objective
The aim of this study is to characterize the risk of serious cardiovascular (CV) events of myocardial infarction (MI), stroke, and arrhythmia and all-cause mortality including CV death associated with the use of romosozumab, in comparison with other available osteoporosis medications in routine clinical practice in the UK as part of a study using 7 databases from Europe. This will be achieved by meeting three objectives: 1) assessing the incidence of cardiovascular outcomes in romosozumab patients; 2) assessing the incidence of cardiovascular outcomes in patients using other osteoporosis medications and 3) assess the comparative risk of cardiovascular outcomes between patients using romosozumab and alendronate.
Population
The population for this study is women aged 50+ with severe osteoporosis who are prescribed one of the below osteoporotic medications. Severe osteoporosis is identified by the presence of 1 or more fractures of any skeletal sites except face/skull/digit/s fractures recorded in the year prior to therapy initiation.
Exposure
The exposure of interest is romosozumab. Comparator exposures are alendronate (primary comparator); ibandronate (oral and intravenous); risedronate; zoledronate; denosumab; and teriparatide.
Outcome
The primary outcome of interest is MACE-2 (first occurrence of death [all cause including cardiovascular (CV) death], MI, or stroke) whilst secondary outcomes are MI; stroke ; death due to CV causes, i.e., MI or stroke; all-cause mortality; MACE-1 (First occurrence of death (CV causes), MI, or stroke), cardiac arrhythmias and atrial fibrillation.
Methods
This will be designed using a cohort study with incidence rates of each outcome for each osteoporosis medication calculated using a Poisson model. Meanwhile, cox proportional hazards with propensity score matching will be used for the comparative risk assessment. Multiple sensitivity analyses including negative controls, self-controlled case series (SCCS), and instrumental variable analysis will assess the results for confounding.
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The risk factors for hospital admission amongst people with parkinsonism in the UK. — Emily Henderson ...
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The risk factors for hospital admission amongst people with parkinsonism in the UK.
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
Emily Henderson - Chief Investigator - University of Bristol
Emma Tenison - Corresponding Applicant - University of Bristol
Anita McGrogan - Collaborator - University of Bristol
Chris Metcalfe - Collaborator - University of Bristol
Chris Salisbury - Collaborator - University of Bristol
Md Khadimul Anam Mazhar - Collaborator - University of Bristol
MÃcheál à Breasail - Collaborator - University of Bristol
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes:
Emergency department attendance and/or unplanned hospital admission (all cause, as well as those for ambulatory care sensitive conditions); length of stay; mortality; outcomes of offspring of PwP, where admission is related to pregnancy including gestational age, pregnancy outcome, mode of delivery, birth weight of the baby, Apgar scores at 1 and 5 minutes, muscle tone at 6 weeks, and other markers of neurological function (such as hearing and vision), developmental growth parameters.
We wish to include a number of additional pregnancy data to those already listed above, these are:
Hospital admission during pregnancy
Obstetric complications
Gestational age at delivery
Spontaneous birth / induction of labour or elective caesarean section (c/s)
Neonate admitted to SCBU / NICU and if so, length of stay
Total postnatal stay in hospital for mother and baby
Offspring outcome (sex, birth weight, Apgar scores, other developmental growth parameters (if available)
Known teratogens
Relevant comorbidities in the motherDescription: Technical Summary
People with parkinsonism (PwP) are more likely than controls to be admitted to hospital and these admissions are longer and more costly on average, with higher inpatient mortality. PwP may suffer a deterioration in motor symptoms following hospitalisation. Amongst the general population, admissions for so-called âambulatory care sensitive conditionsâ are considered potentially avoidable. Amongst PwP attending non-UK international centres of excellence, presence of a deep brain stimulator, motor fluctuation and higher number of comorbidities were associated with unplanned hospital use. Risk of readmission was associated with comorbidity count and caregiver strain.
This study aims to describe the rates of, and reasons for, admission amongst PwP and identify the risk and predictors for unplanned admission. Mixed effects Poisson regression will be used to establish predictors of hospitalisation using demographic and clinical characteristics. For admitted patients, we will describe the predictors of outcomes, including length of stay (LOS), mortality and, for admissions associated with pregnancy, the outcomes in the offspring. For the subgroup of PwP with a co-resident partner, we will investigate the association between caregiver health and risk of admission for PwP. We will also compare admission risk in PwP and controls without parkinsonism to look for an interaction between parkinsonism and morbidity. A case-control design will be used to explore events, such as prior GP contacts, in PwP admitted, compared to those not admitted.
These findings will inform a multicomponent intervention aiming to target PwP at greatest risk of negative outcomes, particularly hospitalisation. Identifying the predictors of admission in PwP will provide the empirical basis to risk stratify participants into a trial and target the intervention appropriately. Identifying high risk time windows for a potentially avoidable admission, along with modifiable risk factors, will allow us to intervene to address these to reduce admission risk or, if unavoidable, reduce LOS.
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Venous Thromboembolism and Cancer Treatment, Outcomes and Resource Use in England — Dimitra Lambrelli ...
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Venous Thromboembolism and Cancer Treatment, Outcomes and Resource Use in England
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-08
Organisations:
Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Sophie Graham - Corresponding Applicant - Evidera, Inc
Aaron Jenkins - Collaborator - Pfizer Ltd - UK
Beth Nordstrom - Collaborator - Evidera, Inc
Binglin Yue - Collaborator - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Mireia Raluy Callado - Collaborator - Evidera, Inc
Raza Alikhan - Collaborator - University Hospital of Wales
Robert Donaldson - Collaborator - Evidera, Inc
Sophie Graham - Collaborator - Evidera, IncOutcomes:
Outcomes to be measured
⢠Baseline characteristics: demographics; clinical characteristics (i.e., comorbidities); transient risk factors for VTE; other risk factors for VTE; previous procedures; prior medications; cancer-related variables.⢠Treatment patterns: discontinuation (includes complete discontinuation, interruptions and switches); persistence.
⢠Health care resource use: inpatient visits (day and overnight stay); outpatient visits; primary care visits (GP and nurse visits) length of hospital stay. These visits will be presented as all-cause, VTE-related and bleeding-related.
⢠Safety outcomes: major bleeding (overall and stratified by site: gastrointestinal (GI), intracerebral hemorrhage and other); clinically relevant non-major (CRNM) bleeding (overall and stratified by site: GI and other).
⢠Effectiveness outcome: VTE recurrence. The definition of VTE recurrence will be explored during Phase I. It is expected that a VTE recurrence will be identified if it occurs after a certain time window after the VTE index date. In addition, there is likely to be a requirement for a diagnostic scan (e.g., CT, ultrasound) scan within a certain time window of the VTE code.
Description: Technical Summary
Venous thromboembolism (VTE) is characterised by the formation of blood clots in blood vessels, and includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients with cancer are six times more likely to develop VTE compared with their non-cancer counterparts, and cancer-related VTE is associated with an increased risk of developing recurrent VTE and major bleeding compared to VTE in non-cancer patients. Common VTE treatment options include the use of anticoagulants. Traditional treatment involves warfarin, and low molecular weight heparin (LMWH). However, direct oral anticoagulants (DOACs) are likely to replace warfarin given the evidence of non-inferiority in randomised trials, and their association with reductions in the risk of bleeding. However, evidence on the effectiveness of DOACs compared with LWMH/warfarin therapy for patients with VTE and cancer is lacking. The aim of the current study is to describe patient characteristics, treatment patterns and healthcare resource utilisation in VTE patients with cancer in Europe receiving anticoagulant medication , and compare the effectiveness and safety of DOACs vs warfarin and LMWH. The main effectiveness outcome will be VTE recurrence, whilst the main safety outcome will be major bleeding. The study will be conducted in two groups: one group of patients with VTE and active cancer, and another group of patients with VTE and history of cancer.
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Understanding the association between diabetes and severe COVID-19 infection. — John Dennis ...
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Understanding the association between diabetes and severe COVID-19 infection.
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-01
Organisations:
John Dennis - Chief Investigator - University of Exeter
John Dennis - Corresponding Applicant - University of Exeter
Andrew Hattersley - Collaborator - University of Exeter
Andrew McGovern - Collaborator - University of Exeter
Beverley Shields - Collaborator - University of Exeter
Bilal Mateen - Collaborator - Wellcome Trust
Jack Bowden - Collaborator - University of Exeter
Kashyap Patel - Collaborator - University of Exeter
Katherine Young - Collaborator - University of Exeter
Nicholas John Thomas - Collaborator - University of Exeter
Sebastian Vollmer - Collaborator - University of Warwick
Spiros Denaxas - Collaborator - University College London ( UCL )
William Henley - Collaborator - University of ExeterOutcomes:
Primary outcome:
Severe Covid-19 infection identified, in patients with confirmed COVID-19 infection, using a composite of: All-cause death, or admission to a critical care unit, or mechanical ventilation, or non-invasive ventilation, new commencement of renal dialysis/filtration, or requirement for high flow oxygen, within 30 days of COVID-19 infection.
Secondary outcomes:
⢠Admission to hospital with COVID-19, defined by either a new hospital admission over the study period, and either a confirmed COVID-19 infection or ICD-10 code for confirmed or suspected COVID-19.
⢠Admission to critical care with COVID-19, defined by either a new hospital admission over the study period, and either a confirmed COVID-19 infection or ICD-10 code for confirmed or suspected COVID-19.
⢠Confirmed or suspected death from COVID 19, as recorded on death certificate or death occurring in a patient with confirmed COVID-19 infection.
⢠Long-term health outcomes in people with diabetes who recover from COVID-19 infection.Description: Technical Summary
Diabetes is one of the most common comorbidities seen in people with COVID-19. As the pandemic has progressed, worse prognoses for people with diabetes who contract COVID-19 have been reported in population-based studies, with an increased risk of intensive care admission and higher mortality in the majority of hospital cohorts. This study will use Clinical Practice Research Datalink (CPRD) primary care records, linked to Second Generation Surveillance (SGSS) data for COVID-19 testing, and COVID-19 hospital records (Hospital Episode Statistics (HES), COVID-19 Hospitalisation in England Surveillance System (CHESS)). In people with diabetes we will identify those infected with COVID-19, and those who develop severe COVID-19. We will examine diabetes specific clinical prognostic factors for development of severe COVID-19 (a composite endpoint of mortality, admission to hospital critical care, ventilation, renal dialysis/filtration, or high-low oxygen), in particular blood glucose control and routine blood tests, diabetes duration, diabetes complications and medication. Advanced methods to control for measured and unmeasured confounding, including the Prior Event Rate Ratio method, will be used to evaluate specific prognostic factors, in particular medication use. We will also examine longer-term outcomes, up to one year, in people with diabetes who recover from COVID-19 infection, compared to a matched control population of COVID-19 unexposed people with diabetes. The study will provide robust data on whether potentially modifiable risk factors such as hyperglycaemia and medication alter risk of developing severe COVID-19, and establish if there are subgroups of people with diabetes that differ to a clinically relevant degree in COVID-19 outcome. We will work with Diabetes UK, the study funder, to rapidly disseminate findings.
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A cohort study of the care home population in CPRD Aurum — Martin Gulliford ...
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A cohort study of the care home population in CPRD Aurum
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-15
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Emma Rezel-Potts - Collaborator - King's College London (KCL)Outcomes:
Whether living in a care home or nursing home. Frailty status using the eFrailty Index. Comorbidity using the Charlson Index. Dementia diagnoses. All-cause mortality. Drug utilisation and polypharmacy. Covid-19 diagnosis.
Description: Technical Summary
The CPRD Aurum database offers an opportunity to conduct epidemiological studies of care home residents. The project aims to provide initial descriptive data for the care home population in CPRD Aurum. The research aims to evaluate the proportion of patients in CPRD Aurum that are living in care homes and nursing homes; to describe their characteristics in terms of frailty status, comorbidity, dementia diagnoses and polypharmacy; to evaluate Covid19 diagnoses in care home residents; and to evaluate all-cause mortality in care home residents. We will conduct a cohort study of patients recorded as living in a care home between 2006 and 2020. We will select age, sex and general practice matched controls. For care home patients and controls we will evaluate frailty status using the eFrailty index, comorbidity using the Charlson Index, dementia diagnoses, all-cause mortality, drug utilisation and polypharmacy and Covid-19 diagnosis. Conditional logistic regression will be employed to compare care home patients and comparators. Survival analysis methods will be employed to evaluate the prognosis of care home patients in terms of all-cause mortality. We will evaluate whether mortality in the care home population has increased since the pandemic started in the UK on 29th January 2020 by using an interrupted time series design. We hope that the research will provide evidence that will help to confirm whether or not CPRD Aurum patients are resident in care homes. The research will also provide basic descriptive data for this population, which can be studied further in future projects.
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Emotional and behavioural dysregulation markers in late childhood and early adolescence as risk factors for mental illness and healthcare utilisation in young people at the age of 18-24 — Dasha Nicholls ...
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Emotional and behavioural dysregulation markers in late childhood and early adolescence as risk factors for mental illness and healthcare utilisation in young people at the age of 18-24
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-08
Organisations:
Dasha Nicholls - Chief Investigator - Imperial College London
Ana Pascual Sanchez - Corresponding Applicant - Imperial College London
Dougal Hargreaves - Collaborator - Imperial College London
Geva Greenfield - Collaborator - Imperial College London
Hanna Creese - Collaborator - Imperial College London
Sonia Saxena - Collaborator - Imperial College LondonOutcomes:
Our Primary outcome is likely mental illness at age 18-24 years. We will define likely mental illness as one or more of the following:
1) Specified diagnosis mental illness Read code (as defined in Appendix B); number of episodes (e.g. depressive episodes with evidence of remission between). Age group will be employed to identify age specific diagnoses
2) Use of psychotropic medications (e.g. antidepressants, anxiolytics, antipsychotics) for â¥6 months (first prescription to first discontinuation for each patient). We will also analyse, if available, time to treatment initiation (age at diagnosis to age at first prescription).
3) Referral to specialist Mental Health services: reason for referral, type of healthcare setting (e.g. IAPT, outpatient mental health, inpatient mental health)
4) Attendance at A&E for mental health reasons (e.g. psychotic episode, attempted suicide, non-suicidal self-injury).
Health resource utilization:
We will use records that measure healthcare utilisation (e.g. frequent attenders, referrals to mental health settings, emergency visitsâ¦). We will take into account:
1) Frequency of contact with primary care for mental health or physical symptoms
2) Frequency of referrals to mental health services
3) Frequency of mental health crisis presentations e.g. A&E visits for overdoses or non-suicidal self-injury (NSSI)), Mental Health Act assessmentsDescription: Technical Summary
The incidence of mental illness in children and young people is reportedly rising, with one in eight having a diagnosable disorder. Furthermore, 75% of mental illness starts before the mid-20s and 50% before the mid-teens. Younger age at psychopathology symptom onset is a significant predictor of functional impairment in later life. Adolescence is therefore a crucial time for early recognition and intervention. Emotional and behavioural dysregulation has been shown to underlie several types of psychopathology in children and adolescents. However, adolescentsâ emotional states also show considerable normal variation. Distinguishing early signs of, for example, depression or anxiety, from normal mood variation at this age can be challenging. However, few studies have examined how these symptoms evolve over the course of adolescence to become mental disorder. Studies are needed to assess the likelihood that help seeking in Primary Care for emotional and behavioural dysregulation in adolescence are early signs of mental illness requiring intervention.
We will use a retrospective cohort design using CPRD data to investigate if primary care consultations for mental health symptoms in late childhood and early adolescence (8-14 years) predict mental illness and healthcare utilisation in young adults aged 18-24 years.
Using logistic regression, we will examine whether emotional and behavioural dysregulation markers (such as anxiety, emotional upset or behavioural problems) in late childhood and early adolescence predict later mental health diagnoses, use of psychotropic medications, mental health referrals, hospitalisations and emergency department attendance for mental health reasons (e.g. for attempts of suicide such as overdoses) in young adulthood.
Using Poisson regression, we will address if these early consultations predict the frequency of healthcare utilisation.
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Patterns of multimorbidity, multimorbidity clusters and associations with mortality in patients with intellectual disabilities in the UK. — Deborah Kinnear ...
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Patterns of multimorbidity, multimorbidity clusters and associations with mortality in patients with intellectual disabilities in the UK.
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-08
Organisations:
Deborah Kinnear - Chief Investigator - University of Glasgow
Kirsty Dunn - Corresponding Applicant - University of Glasgow
Angela Henderson - Collaborator - University of Glasgow
Barbara Nicholl - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
Duncan Edwards - Collaborator - University of Cambridge
Kate O'Donnell - Collaborator - University of Glasgow
Rupert Payne - Collaborator - University of BristolOutcomes:
Primary Outcomes
Prevalence of long-term physical and mental health conditions and those occurring together for different age groups (18-44, 45-64, 65-84, and 85+ years of age); Pairs of any two separate morbidities from the designated list of 43 long-term conditions (Appendix 1)Secondary Outcomes
Number of primary care consultations (in-person or by phone); Number of repeat prescriptions (at least four times in a year by counting the unique British National Formulary (BNF) codes) per patient; Number of hospital admissions (defined by discharge dates); Mortality at two and five years after first record of both diseasesDescription: Technical Summary
The management of multimorbidity (two or more long-term physical and/or mental health conditions) has risks of disease-disease interactions, drug-disease interactions and drug-drug interactions. It is increasingly recognised that diseases tend to occur together, which has led to an emerging interest in the natural clustering of diseases in the adult general population. Understanding and treating multimorbidity is also a major policy priority in the UK. Adults with intellectual disabilities (requiring support for daily activities, with onset before adulthood) have a point prevalence of mental ill-health of 41%, and 99% have multiple physical and/or mental health conditions (multimorbidity). However, no previous studies have investigated patterns of natural clustering of diseases in adults with intellectual disabilities who experience different health conditions to those seen in the general population.
The aim of the proposed study is to describe the extent of multimorbidity in adults with intellectual disabilities compared to the general population, and investigate characteristics, service use, and mortality in clusters of multi-morbid diseases. For this population-based study, we will use primary care records, derived from general practice information systems, linked anonymously with secondary care data from Hospital Episode Statistics Admitted Patient Care, Outpatient and A&E data, the Mental Health Services Data Set, and ONS Death Registration Data. We plan to use the linkage of these data provided by the Clinical Practice Research Datalink Gold and Aurum datasets.
This research will include a cross-sectional, descriptive study of the prevalence of multimorbidity in patients with and without intellectual disabilities, and a retrospective cohort analysis investigating the relationship between multimorbidity, health service utilisation and mortality. We will describe the prevalence of multimorbidity and will investigate patterns of the most common comorbidities using latent class analysis. We will use regression models to examine how health service utilisation and mortality may differ according to the presence of multimorbidity.
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Investigating drug-disease relationship through directed graph mapping: interactions, indications and contraindications — Alvina Lai ...
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Investigating drug-disease relationship through directed graph mapping: interactions, indications and contraindications
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-15
Organisations:
Alvina Lai - Chief Investigator - University College London ( UCL )
Yen Yi Tan - Corresponding Applicant - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Stefanie Mueller - Collaborator - University College London ( UCL )
Vaclav Papez - Collaborator - University College London ( UCL )Outcomes:
⢠Indication and contraindication relationship between drugs and diseases
⢠Interaction relationship between drugs and drugsThe above outcomes will be integrated using the following external sources of information: British National Formulary and British National Formulary for Children.
⢠Comorbidity relationship between diseases and diseases
⢠Prescribing patterns by drug and condition
⢠Frequency of prescribing patterns per conditions
⢠All-cause mortality, cause-specific mortality, mortality rate by disease and prescribing patterns
⢠Prevalence and incidence of diagnoses
⢠Identification of indication-contraindication pairs to drugsDescription: Technical Summary
We aim to create an interpretable, accessible and user-friendly directed knowledge graph framework using standardised clinical terminology mapping the relationship between drugs and diseases, within drugs and within diseases. Using linked primary and secondary care data (CPRD/HES) will allow establishment of the relationship between drug prescriptions and conditions for which the drugs are prescribed for. Many existing databases attempting similar aims are incomplete and non-standardised, not available to end-users and exist in mostly unstructured free text. Our framework will consist of a backend SQL database containing entities labelled by standardised medical terminology (HES ICD-10, CPRD and OPSC read codes, and BNF labels) with front end knowledge graph accessibility through a basic user query tool and an integrated clinician/researcher clinical decision support system tool.
Relative risk ratios will be used to determine the risk of occurrence of comorbidities, the risk of diagnoses in different groups or given a prescribing pattern. Propensity score matching will be employed to minimise confounding effects. Cox proportional hazard regression will be used to ascertain associations between treatment and outcomes in single or multi-drug treatment. All-cause and cause-specific mortality in prevalence disease and at the 1 year post-diagnosis for incident disease will be established.
Such a framework will aim to improve and inform clinical treatment decisions by accounting for multimorbidity through identifying all known harmful interactions that may not be clearly presented using current singular drug prescription clinical guidelines. Our framework will also aim to identify drugs that may be used to treat a patient with commonly associated comorbidities that present as a contrasting indication-contraindication pair to the drug. In such a case, the net benefit/harm in drug administration within such multimorbidity is likely to be unclear and such findings can result in the formation of guiding hypotheses for further investigation into treatment dilemmas.
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Non-Interventional retrospective longitudinal study in the UK to evaluate and identify the best practices for switching of valproate and related substances in clinical practice — Florence COSTE ...
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Non-Interventional retrospective longitudinal study in the UK to evaluate and identify the best practices for switching of valproate and related substances in clinical practice
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-12-02
Organisations:
Florence COSTE - Chief Investigator - Sanofi Aventis Recherche & Développement
Florence COSTE - Corresponding Applicant - Sanofi Aventis Recherche & Développement
Cindy Li - Collaborator - Sanofi US Services IncOutcomes:
The primary outcome will be the occurrence of a successful switch after valproate discontinuation, defined as 12 months continuous use of the newly switched drug, which represents an appropriate proxy of good tolerance and efficacy. Please, refer to the next section 'Objectives, specific aims and rationale' for justification. 12-months continuous use will be estimated based on prescription records and quantity supplied of the newly switched drug without any gap in supply of more than 30 days.
The patterns of valproate discontinuation and switch to other medication(s) will be described among patients who meet this primary outcome; then, the association between specific patterns and this success criteria will be evaluated.
The following secondary outcomes will be considered:
⢠Absence of clinical relapse for either epilepsy or bipolar disorder within the 1-year period after index date, as a proxy of clinical stability. Relapse will be defined as at least one hospitalization or emergency room (ER) visit for indication-specific reasons. Information related to specialist outpatient care delivered at hospitals will be considered to build an algorithm for proxy of clinical relapse in patients without linkage to inpatient hospital data,
⢠Absence of valproate re-initiation during the follow-up period.The patterns of valproate discontinuations and switch to other medication(s) will be described among patients who meet the primary outcome and the secondary outcome âabsence of clinical relapseâ as well as in patients who meet the primary outcome and both secondary outcomes.
The following other outcomes will also be considered:
⢠Hospitalization or ER visits for selected diagnoses (e.g. for suicide attempt, for psychiatric conditions other than bipolar disorder),
⢠Number of office visits to GP, Neurologist or Psychiatrist or other medical specialty (gynecologist) or other relevant health care professionals (epilepsy nurse in the UK),
⢠Death.Description: Technical Summary
Valproate is licensed to treat epilepsy and bipolar disorder in Europe; however, it is associated with significant teratogenicity risks. Discontinuation of valproate and switching to another medication in women of child-bearing potential (WCBP) and pregnant women was discussed with the EMA and clinical experts during an Article 31 referral procedure, and it was agreed that the available recommendations were limited for clinical practice. Therefore, the PRAC requested the pharmaceutical companies marketing valproate to conduct an observational retrospective study in order to identify the best practices for discontinuation or switch of valproate to support the guidelines release. CPRD was selected as one of the appropriate data sources because of its national coverage and high representativeness of the primary care setting.
The primary objective is to identify patterns of switching or discontinuation of valproate associated with a successful switch after valproate discontinuation (defined below), and to evaluate the association between patientsâ and disease characteristics with a successful switch after valproate discontinuation, in WCBP chronic users of valproate and in a sub-population of pregnant women.
This is a retrospective cohort study of WCBP chronic users of valproate for epilepsy or bipolar disorder, who discontinued valproate during the inclusion period (2014-2017), with up to one-year follow-up.
The primary outcome is the occurrence of a successful switch after valproate discontinuation, defined as 12 months continuous use of the newly switched drug (more details in the next section). The secondary outcomes are: 1) absence of clinical relapse within the follow-up period after index date as a proxy of clinical stability and 2) absence of valproate re-initiation.
Descriptive analyses will be conducted to describe the patterns of valproate discontinuation and use of new medication(s). Identification of risk factors associated with a successful switch will be assessed using a multivariable Cox proportional hazards regression model
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ID 100: De-identified Data Access Request: To understand more about the real-world pathway and burden of patients with diabetic foot ulceration and associated outcomes — Imperial College Healthcare NHS Trust...
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ID 100: De-identified Data Access Request: To understand more about the real-world pathway and burden of patients with diabetic foot ulceration and associated outcomes
Legal basis:Healthcare delivery and Planning
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Diabetic foot ulceration.
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ID 94: De-identified Data Access Extension Request: To assess the maternal vaccination uptake in the Northwest (NWL) — Imperial College London...
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ID 94: De-identified Data Access Extension Request: To assess the maternal vaccination uptake in the Northwest (NWL)
Legal basis:Research and Healthcare Planning
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-20
Opt Outs: no information provided./p>
Organisations: Imperial College London
Description: North West London vaccination.
Source
2020 - 11
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Data Science Covid-19 Care Home Shielding (Aggregate (small numbers supressed)) (Secondary Uses) — National Audit Office...
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To enable the National Audit Office to assess the effectiveness of shielding for people in care homes. — IG-01259
Recipient Data Controller Organisation(s) : National Audit Office
Approval Date: 11/11/2020
Purpose for which the data is being used: To enable the National Audit Office to assess the effectiveness of shielding for people in care homes.
Dataset: Data Science Covid-19 Care Home Shielding
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
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NHS Pathways 111/999 Telephony data (Aggregate (small numbers not supressed)) (Secondary Uses) — Department of Health and Social Care...
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To support analysis related to the COVID-19 NHS Test & Trace Programme and to support the UK and Devolved Governmentsâ responses to the COVID-19 challenge. — IG-00990_5
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 06/11/2020
Purpose for which the data is being used: To support analysis related to the COVID-19 NHS Test & Trace Programme and to support the UK and Devolved Governmentsâ responses to the COVID-19 challenge.
Dataset: NHS Pathways 111/999 Telephony data
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
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COVID-19 SitReps (Aggregate (small numbers supressed)) (Secondary Uses) — NHS England / Improvement...
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To understand the extent to which key services which were asked to partially stop activity have come back on stream again. This will assist in assessing readiness and resilience amongst providers of community health services in responding to a second wave of COVID-19 and/or dealing with wider Winter pressures. — IG-00522_2
Recipient Data Controller Organisation(s) : NHS England / Improvement
Approval Date: 06/11/2020
Purpose for which the data is being used: To understand the extent to which key services which were asked to partially stop activity have come back on stream again. This will assist in assessing readiness and resilience amongst providers of community health services in responding to a second wave of COVID-19 and/or dealing with wider Winter pressures.
Dataset: COVID-19 SitReps
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
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COVID-19 SitReps (Aggregate (small numbers supressed)) (Secondary Uses) — NHS England / Improvement...
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To support the operational planning and delivery of NHS services in response to COVID-19 — IG-00522_3
Recipient Data Controller Organisation(s) : NHS England / Improvement
Approval Date: 26/11/2020
Purpose for which the data is being used: To support the operational planning and delivery of NHS services in response to COVID-19
Dataset: COVID-19 SitReps
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
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COVID-19 Vitamin D CEV Service (Identifiable) (Direct Care) — Department of Health and Social Care...
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As part of the pandemic response, clinically extremely vulnerable patients (i.e. those on the Shielded Patient List) will be offered a one-off course of vitamin D tablets. — IG-01452
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 30/11/2020
Purpose for which the data is being used: As part of the pandemic response, clinically extremely vulnerable patients (i.e. those on the Shielded Patient List) will be offered a one-off course of vitamin D tablets.
Dataset: COVID-19 Vitamin D CEV Service
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice & Express Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice & Express Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Legal obligation overrides. Also for purposes of care of the relevant individuals
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Shielded Patient List (SPL) (Identifiable) (Secondary Uses) — NHS Business Services Authority...
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During national shielding and local lockdown, prescriptions are delivered for shielding patients funded by public funds, this service was to enable patients to shield effectively while still receiving medications. Community pharmacies claim the cost of delivery back from NHS BSA for the delivery of prescriptions to shielding patients. NHS Business Services Authority (NHS BSA) operate the prescription charging assurance functions for the NHS in England. They have been instructed by NHS England/Improvement to include those functions for Shielded Patient pharmacy post payment verification. — IG-00872
Recipient Data Controller Organisation(s) : NHS Business Services Authority
Approval Date: 10/11/2020
Purpose for which the data is being used: During national shielding and local lockdown, prescriptions are delivered for shielding patients funded by public funds, this service was to enable patients to shield effectively while still receiving medications. Community pharmacies claim the cost of delivery back from NHS BSA for the delivery of prescriptions to shielding patients. NHS Business Services Authority (NHS BSA) operate the prescription charging assurance functions for the NHS in England. They have been instructed by NHS England/Improvement to include those functions for Shielded Patient pharmacy post payment verification.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Re-evaluating the clinical and cost effectiveness of implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy with defibrillation (CRT-D) for heart failure using real world data from the Clinical Practice Research Datalink. — Puja Myles ...
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Re-evaluating the clinical and cost effectiveness of implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy with defibrillation (CRT-D) for heart failure using real world data from the Clinical Practice Research Datalink.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-19
Organisations:
Puja Myles - Chief Investigator - CPRD
Tarita Murray-Thomas - Corresponding Applicant - CPRD
- Collaborator -
Alex Bottle - Collaborator - Imperial College London
Reza Skandari - Collaborator - Imperial College LondonOutcomes:
- HF treatment patterns (prescription rate, combination therapy, optimal therapy)
- HF treatment adherence
- HF complication rates
- Health care resource use and cost (any cause, and HF-related)
- Hospitalisations (any cause, and HF-related)
- Mortality (All cause, Cardiovascular- related, HF-related)
- Combined end point of hospitalisation or mortalityDescription: Technical Summary
Current recommendations on ICD/CRT-D for treating heart failure in the English NHS are largely based on clinical and cost effectiveness evidence from RCTs. However, RCTs may not be representative of HF patients treated in routine clinical practice or reflect real world health service delivery. We will assess the comparative effectiveness of outcomes among patients with HF treated with ICD/CRT-D versus HF drug therapy alone to inform decision analysis and stochastic cost effectiveness models.
Patients 18 years and older with incident heart failure recorded in primary care or hospital during 01/01/2008-31/12/2018 will be extracted from the Clinical Practice Research Datalink. Index date will be defined as the earliest date of HF drug therapy following HF diagnosis. Patients will be followed at 3,6,12,24 months up to 5 years following index date for all-cause mortality (primary outcome), HF or cardiovascular death, any-cause hospitalisation, complication rates, use of health care services and associated costs. Treatment adherence will be explored as a driver of outcomes.
Instrumental variable, propensity score matched analysis and conventional statistical methods will be used to assess relative treatment effectiveness. Survival models such as Cox proportional hazard or other flexible models will be used to estimate time to mortality; generalised linear models such as Poisson regression models will be used to assess rates of hospitalisation and complications. Lifetime costs will be estimated using a flexible two-part model employing logistic regression and generalised linear models with a gamma distribution.
The cost per quality-adjusted-life year gained and incremental net health benefit over a lifetime horizon, from the NHS perspective, will be estimated in cost effectiveness analysis. Results from economic models will provide insights on the extent to which clinical data from everyday practice could be used to inform policy decisions about the introduction of cost-effective HF treatment in the NHS.
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Effects of oral anticoagulation in patients with atrial fibrillation and close-to-threshold stroke risk score (CHA2DS2-VASc) or chronic kidney disease: A regression discontinuity analysis — Till Bärnighausen ...
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Effects of oral anticoagulation in patients with atrial fibrillation and close-to-threshold stroke risk score (CHA2DS2-VASc) or chronic kidney disease: A regression discontinuity analysis
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-18
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Maike Hohberg - Corresponding Applicant - University Hospital Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Manuel Hoffmann - Collaborator - University of Heidelberg
Maximilian Schuessler - Collaborator - University of Heidelberg
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
Primary outcomes:
To be analysed after five years follow-up from atrial fibrillation diagnosis:
- probability of an embolic event (stroke, renal infarction, splenic infarction, peripheral ischaemia) until follow-up
- probability of non-traumatic intracranial haemorrhage
- probability of requiring dialysis until follow-up
- number of GP visits until follow-up
- number of emergency hospitalizations (and their duration) until follow-up
- all-cause mortality until follow-upSecondary outcome:
To be analysed after five years follow-up from atrial fibrillation diagnosis:
- estimated glomerular filtration rate (most recent before end of follow-up period)
- number of hospitalizations due to renal failure until follow-up
- mortality due to renal failure until follow-up
- risk of osteoporotic fractures
- dementia
- disabilityDescription: Technical Summary
Anticoagulation is generally recommended above a CHA2DS2-VASc score â¥2 in men or ⥠3 in women with atrial fibrillation. Treating patients with atrial fibrillation close to these thresholds is clinically contentious as the benefits from treatment (prevention of cardiovascular accidents) are relatively small compared to its risks (bleedings). For patients with severe renal impairment, some families of anticoagulants are contraindicated. As a result, physicians face a trade-off in clinical decision making because switching to other families of anticoagulants and withholding potentially effective treatments from patients in order to protect renal function may pose alternative health risks. Understanding the health effects of this trade-off is therefore critical for clinical practice. Here, we focus on different patient subpopulations: (i) with low CHA2DS2-VASc score and (ii) study the use of DOACs in patients with advanced kidney disease. Previous observational studies investigating the health effects of anticoagulants (and DOACs in particular) rely on identification of effects by adjusting for observable confounders but are unable to control for unobserved variables â and, therefore, cannot establish causality. Randomized controlled trials, in turn, might not be able to fully capture treatment effectiveness during routine care and frequently lack the time horizon to study long-term outcomes. By contrast, this study makes use of a regression discontinuity (RD) design, enabling the identification of causal effects in routine care with long-term outcomes. For this purpose, we draw on major clinical guidelines providing advice on the use of anticoagulants based on threshold rules related to the CHA2DS2-VASc score and patientsâ glomerular filtration rate (GFR). Because physicians base their treatment decisions on considerations besides clinical guidelines, we use an instrumental variable approach that is robust to partial compliance. Our findings are expected to provide novel insights into the health effects of anticoagulants in patients with low CHA2DS2-VASc score and on DOACs therapy.
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Health Outcomes Arising from Human-Animal Interactions Including Zoonotic Disease and Antimicrobial Resistance — Alex Cook ...
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Health Outcomes Arising from Human-Animal Interactions Including Zoonotic Disease and Antimicrobial Resistance
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-18
Organisations:
Alex Cook - Chief Investigator - University of Surrey
Georgina Cherry - Corresponding Applicant - University of Surrey
Andrew Hancock - Collaborator - Zoetis Inc.
Chris D Poole - Collaborator - Digital Health Labs Limited
Georgina Cherry - Collaborator - University of Surrey
Isaac Odeyemi - Collaborator - Zoetis Inc.
James Frost - Collaborator - Digital Health Labs LimitedOutcomes:
Zoonoses incidence (disaggregated); Charlson Co-morbidity Index; all-cause mortality; healthcare resource use expressed as nor only rate but also cost for each of: GP consultation; other primary care consultations; hospital admissions; A&E attendance; outpatient referral; antibiotic usage; antibiotic treatment failure; antimicrobial resistance
Description: Technical Summary
That animal and human health are interdependent is increasingly recognised. Sixty percent of infectious diseases in humans are zoonotic, but despite their combined prevalence and statutory reporting in the UK, zoonoses are poorly studied. Of additional concern is antimicrobial resistance (AMR) and its relationship to antibiotic use in food animals where agricultural and animal health workers are directly at risk of colonization with drug-resistant bacteria through close contact with infected animals.
This study has two objectives: 1) to characterise the burden of human illness associated with a range of zoonotic diseases; and 2) to explore the association between occupational exposure to food animals and antimicrobial treatment patterns (ATP), antibiotic treatment failure (ATF), and reported AMR.
Objective 1 has the following aims with respect to zoonotic diseases: 1) chart epidemiological trends (primary); 2) describe phenotypic susceptibility; 3) characterise acute and chronic co-morbid sequelae; 4) enumerate not only excess mortality but also 5) excess health resource use arising. Objective 2 will be met by comparing antimicrobial treatment patterns, ATF, and AMR between agricultural workers, co-habitants and matched controls.
Matched cohorts will utilise the CPRD GOLD and Aurum datasets and linked HES, mortality, deprivation, and rurality data. To objective 1, primary exposure is a diagnosis of a notifiable zoonotic disease while principal outcomes are age-sex adjusted co-morbidity, all-cause mortality, and disaggregated health resource use. To objective 2, agricultural and animal health workers and co-habitants will be matched to non-agriculturally occupied controls where ATP is described by annual incidence per infection type; ATF by either 2nd-line antibiotic or clinical failure following first antibiotic for specified infection; with AMR determined from clinical codes and laboratory results.
Event rates between cases and matched controls will be assessed by Poisson regression, ATF likelihood by conditional logistic regression, and healthcare cost differences by generalised linear modelling.
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Use and effectiveness of physical activity and dietary based lifestyle interventions for obesity — Till Bärnighausen ...
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Use and effectiveness of physical activity and dietary based lifestyle interventions for obesity
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-11
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Maximilian Schuessler - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
We will explore the effects on the following primary outcomes:
- BMI
- Blood cholesterol levels (HDL, LDL, total cholesterol)
- Blood pressure
- Smoking status
- Recorded hazardous alcohol consumptionWe will also explore the following secondary outcomes
- Number of all-cause emergency hospitalizations
- Number of cardiovascular disease-related emergency hospitalizations
- Number of severe adverse health events (stroke, heart attack [myocardial infarction] â each event type evaluated separately)
- All-cause mortality
- Number of GP visits
- Number of medicationsDescription: Technical Summary
This study focusses on the patterns of use and real-life effectiveness of lifestyle intervention programmes in UK primary care. Previous studies investigating the health effects of lifestyle intervention administered to people diagnosed with obesity are largely limited to controlled clinical trials and small-scale observational studies. First, this study seeks to explore the use of lifestyle interventions in UK primary care in adherence to current guidelines for obesity, for which they are recommended as a first line option, by studying the proportion of patients who received a structured lifestyle intervention upon their diagnosis of obesity. Second, while previous studies have pointed towards the efficacy of lifestyle interventions in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Thus, we aim to explore the effect of lifestyle intervention on short-, mid-, and long-term physical and behavioral outcomes in a routine care set-up for adult men and adult women. Finally, we will test for heterogenous treatment effects by stratifying our sample by sex, age, socioeconomic status, ethnicity and comorbidities. The findings of this study are expected to provide novel insights into the use and effectiveness of lifestyle interventions in a real-life setting and can directly inform clinical practice.
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Polycystic ovarian syndrome and metformin use in pregnant woman. Possible reduction of fetal loss. A cohort study in the Clinical Practice Research Datalink. — Caroline Foch ...
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Polycystic ovarian syndrome and metformin use in pregnant woman. Possible reduction of fetal loss. A cohort study in the Clinical Practice Research Datalink.
Datasets:GP data, Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-20
Organisations:
Caroline Foch - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Caroline Foch - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Emmanuelle Boutmy - Collaborator - Merck Healthcare KGaA (Merck Group)
Kerstin Brand - Collaborator - Merck Healthcare KGaA (Merck Group)
Michael Batech - Collaborator - Merck Healthcare KGaA (Merck Group)
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)Outcomes:
Treatment patterns of metformin; Frequency of general practitioner visits (GP); Gestational diabetes mellitus; Pregnancy outcomes; Miscarriage; Preterm live birth.
Description: Technical Summary
Among women with polycystic ovary syndrome (PCOS), the aim of this study is to describe metformin treatment pattern, the frequency of general practitioner visit, the occurrence of gestational diabetes mellitus, and the pregnancy outcomes; and to compare pregnancies exposed to metformin as opposed to pregnancies unexposed to metformin, in terms of miscarriage and preterm live birth.
This study will be a cohort of all eligible pregnancy episodes among women with PCOS. The time scale will be the gestational age, and the last menstrual date (LMP) will be the index date. Pregnancies will be followed from the LMP date, through the earliest of: end of pregnancy, or motherâs death.
The outcomes will be retrieved via the CPRD Pregnancy Register, while the motherâs comorbidities and treatment via CPRD Gold.
Metformin exposure will be defined as a time-varying variable classifying pregnancy into exposed or unexposed at every time point of the follow-up.
A survival approach by the multistate methodology will be implemented. It will investigate the time until one composite outcome and elaborates standard survival analysis to event histories analyses. Pregnancies will be entered at the time of estimated LMP as index date in state 0 if exposed to metformin or state 1 if unexposed; and will be censored at the 260th day of pregnancy as they are no longer at risk for preterm birth or miscarriage. Depending on the exposure status, pregnancies can move between the state 0 and 1. Finally, a pregnancy will be terminated by any of outcome of competing events (state 2, absorbing state): miscarriage, preterm live birth, elective termination of pregnancy, mother´s death, or any other adverse pregnancy outcome (stillbirth, unspecified loss, ectopic, molar, blighted ovum).
Adjusted hazard ratio (Cause specific HR and Subdistribution HR for competing setting) for the outcomes and the competing events will be displayed.
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Use and effectiveness of physical activity and dietary based lifestyle interventions for patients with hypercholesterolaemia — Till Bärnighausen ...
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Use and effectiveness of physical activity and dietary based lifestyle interventions for patients with hypercholesterolaemia
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-16
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Maximilian Schuessler - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
We will explore the effects on the following primary outcomes:
- Blood cholesterol levels (HDL, LDL, total cholesterol)
- Blood pressure
- BMI
- Smoking status
- Recorded hazardous alcohol consumptionWe will also explore the following secondary outcomes
- Number of all-cause emergency hospitalizations
- Number of cardiovascular disease-related emergency hospitalizations
- Number of severe adverse health events (stroke, heart attack [myocardial infarction] â each event type evaluated separately)
- All-cause mortality
- Number of GP visits
- Number of medicationsDescription: Technical Summary
This study focusses on the patterns of use and real-life effectiveness of lifestyle intervention programmes in UK primary care. Previous studies investigating the health effects of lifestyle intervention administered to people diagnosed with hypercholesterolaemia are largely limited to controlled clinical trials and small-scale observational studies. First, this study seeks to explore the use of lifestyle interventions in UK primary care in adherence to current guidelines for cardiovascular disease risk and hypercholesterolaemia, for which they are recommended as a first line option, by studying the proportion of patients who received a structured lifestyle intervention upon their diagnosis of hypercholesterolaemia. Second, while previous studies have pointed towards the efficacy of lifestyle interventions in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Thus, we aim to explore the effect of lifestyle intervention on short-, mid-, and long-term physical and behavioral outcomes in a routine care set-up for adult men and adult women. Finally, we will test for heterogenous treatment effects by stratifying our sample by sex, age, socioeconomic status, ethnicity and comorbidities. The findings of this study are expected to provide novel insights into the use and effectiveness of lifestyle interventions in a real-life setting and can directly inform clinical practice.
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Determining the incidence, prevalence and impact of Psoriatic Arthritis and Fibromyalgia or Chronic Widespread Pain in UK Primary Care: A Health Intelligence Analysis. — John McBeth ...
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Determining the incidence, prevalence and impact of Psoriatic Arthritis and Fibromyalgia or Chronic Widespread Pain in UK Primary Care: A Health Intelligence Analysis.
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-24
Organisations:
John McBeth - Chief Investigator - University of Manchester
Yuanyuan Zhang - Corresponding Applicant - University of Manchester
Belay Yimer - Collaborator - University of Manchester
Jenny Humphreys - Collaborator - University of Manchester
Katie Druce - Collaborator - University of Manchester
Kimme Hyrich - Collaborator - University of Manchester
Ramiro Bravo - Collaborator - University of Manchester
Suzanne Verstappen - Collaborator - University of Manchester
William Dixon - Collaborator - University of ManchesterOutcomes:
- Occurrence and impact of Psoriatic Arthritis
- Occurrence and impact of Fibromyalgia/Chronic Widespread PainDescription: Technical Summary
Rheumatic and musculoskeletal diseases (RMDs) affect ~18.8 million people in the UK. Data about the incidence, prevalence and impact of RMDs is important for workforce/service planning, healthcare budgeting and provision of support. However, the data quality and accuracy behind existing figures is unknown. Further, limited data are available at a population level to understand the impact of RMDs on daily life.
This project will develop an analysis package/framework for estimating the prevalence, incidence and impact of RMDs condition and demonstrate its performance in two exemplar conditions: Psoriatic Arthritis (PsA) and Fibromyalgia/Chronic Widespread Pain (FM/CWP).
Case identification
Cases of adults (aged 18 years and older) with PsA and FM/CWP will be identified in CPRD. Read codes will identify 1) cases with a formal diagnosis (e.g. PsA Read codes present) and 2) cases identified with a bespoke algorithm based diagnoses (e.g. codes for psoriasis + arthritis + treatment used in PsA present).Incidence and prevalence estimation
We will use a two-step Bayesian approach using data from CPRD and prior distributions.
1. The prior distribution of the true prevalence, sensitivity, and specificity of the case identification algorithm will be estimated based on a systematic review and analysis of Manchester Integrated Healthcare Record (MIHR)
2. Prevalence and incidence rates will be calculated, stratified by age, sex, socioeconomic status, and region.Supplementary analysis of MIHR will identify further model refinements needed to improve the precision of estimates.
Impact estimation
We will use a two-step out-of-sample prediction approach:
1. Pre-existing (unlinked) cohort data will be used to estimate and characterise the proportion of people living with the most severe and impactful disease (e.g. high pain, high fatigue and greatest impact on activities of daily living).
2. Multilevel modelling will predict impact in the general population based on these figures and the prevalence estimates identified above.
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The role of clinical and care factors in the delay of heart failure diagnosis and subsequent prognosis: a cohort study using the Clinical Practice Research Datalink (CPRD) — Umesh Kadam ...
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The role of clinical and care factors in the delay of heart failure diagnosis and subsequent prognosis: a cohort study using the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-16
Organisations:
Umesh Kadam - Chief Investigator - University of Leicester
Suping Ling - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Mark Rutherford - Collaborator - University of Leicester
Michael Sweeting - Collaborator - University of LeicesterOutcomes:
(i) delay in the diagnosis of HF
(ii) planned and unplanned hospital admissions
(iii) frailty
(iii) all-cause-mortality and HF-specific mortalityDescription: Technical Summary
Background: Heart Failure (HF) is associated with the poorest quality of life and a poor prognosis. Current evidence suggests that (i) there are significant time delays in the new diagnosis of HF that might contribute to the poor outcomes after diagnosis and (ii) that symptom deterioration in patients with HF prior to unplanned admission is poorly recognised. Diagnosis itself is often made at an unplanned hospital admission rather than in primary care and evidence shows that up to 50% of unplanned admission in HF patients could be avoided. High levels of comorbidity and the associated care complexity likely contribute to sub-optimal care, but this has not yet been explored in any depth.
Design: Case-control and retrospective cohort design
Methods: In the populations aged 40 years and over, the CPRD Gold and Aurum datasets will be used to identify an incident HF cohort. The outcomes data will be ascertained from linked Hospital Episode Statistics (HES) and ONS death data. In three phases, using logistic regression models, flexible parametric models, longitudinal mixed models, and machine learning approaches, there will be an investigation of patient (age, gender, ethnicity), clinical (chronic comorbid conditions and severity, symptoms) and care factors (multiple medications use, routine tests [bloods, imaging], contact patterns), and how they relate to the delay in the diagnosis of HF and the subsequent outcomes of hospital admissions, frailty and death.
Outcomes: This investigation will determine the key patient, clinical and care factors that contribute to significant delays in the diagnosis of new HF and unplanned admissions in HF patients. Identifying these factors provides new opportunities for earlier interventions and in devising clinical and public health policies which significantly improve the care of the patients with HF.
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An assessment of the cardiovascular health of autistic individuals — Simon Baron...
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An assessment of the cardiovascular health of autistic individuals
Datasets:GP data, Risk Score: HbA1C; HDL cholesterol; Non-HDL:HDL cholesterol ratio; BMI Cardiovascular treatments: Prescriptions for statins, beta blockers, ACE inhibitors, diuretics, and calcium-channel blockers Cardiovascular Signs & Symptoms: angina; hypertension; arrhythmias; transient ischaemic attack (TIA) Cardiovascular Outcomes: ischemic stroke; myocardial infarction; heart failure, coronary revascularization procedures Cause of Death: Cardiovascular outcomes (listed above) and Covid-19
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-13
Organisations:
Simon Baron-Cohen - Chief Investigator - University of Cambridge
Elizabeth Weir - Corresponding Applicant - University of Cambridge
Adriana Cherskov - Collaborator - Yale University
Alex Tsompanidis - Collaborator - University of Cambridge
Brigid Kennedy - Collaborator - University of Cambridge
Carrie Allison - Collaborator - University of Cambridge
Rupert Payne - Collaborator - University of BristolOutcomes:
Risk Score: HbA1C; HDL cholesterol; Non-HDL:HDL cholesterol ratio; BMI
Cardiovascular treatments: Prescriptions for statins, beta blockers, ACE inhibitors, diuretics, and calcium-channel blockers
Cardiovascular Signs & Symptoms: angina; hypertension; arrhythmias; transient ischaemic attack (TIA)
Cardiovascular Outcomes: ischemic stroke; myocardial infarction; heart failure, coronary revascularization procedures
Cause of Death: Cardiovascular outcomes (listed above) and Covid-19
Description: Technical Summary
We propose to use the Clinical Practice Research Datalink (CPRD), linkages to the Hospital Episode Statistics (Admitted Patient Care data), Covid-19 linkages, and Office of National Statistics (ONS) Death data linkage to consider the cardiovascular health of autistic individuals, and its relationship to cardiovascular conditions and severe disease from Covid-19. We will use clinical, referral, therapy, and test records to determine whether individuals have increased glycosylated haemoglobin (HbA1C), HDL cholesterol, Non-HDL:HDL cholesterol ratio, BMI, use of medications (e.g. statins, beta blockers, ACE inhibitors, diuretics, and calcium-channel blockers), as well as whether or not individuals are more likely to exhibit hypertension, angina, arrhythmia, transient ischaemic attack (TIA), coronary revascularization procedures, and/or die from stroke, myocardial infarctions, heart failure, or Covid-19. Cohort 1 will consist of autistic individuals and will be matched 5:1 with non-autistic controls on age, sex, and practice (Cohort 2). We will use Cox Regression to determine risk of cardiovascular outcomes, as well as cause of death due to cardiovascular conditions or Covid-19, and composite risk scores will be investigated for association to autism, via linear regression (Pearsonâs coefficient). We will covary for several confounding factors, and will use the Patient-Level Indices of Multiple Deprivation (IMD) linkage to control for socioeconomic status. Missing data on covariates will be imputed via use of Multiple Imputation by Chain Equations (MICE). Mixed effects modelling will be utilized to account for nested data structure. Statistical significance of the results will be adjusted with the application of Benjamini-Hochberg False Discovery Rate. We will use the Mother-to-Baby link to identify non-autistic mothers of Cohort 1; they will make up Cohort 3 and will be matched on age, sex, and practice to the mothers of Cohort 2 (Cohort 4). We will use the same procedure to test the same risk factors and outcomes in this population.
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A population-based longitudinal study in England of suicide risk indicators: behavioural, clinical and biosocial — Timothy Card ...
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A population-based longitudinal study in England of suicide risk indicators: behavioural, clinical and biosocial
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-02
Organisations:
Timothy Card - Chief Investigator - University of Nottingham
Danah Alothman - Corresponding Applicant - University of Nottingham
Andrew Fogarty - Collaborator - University of Nottingham
Sarah Lewis - Collaborator - University of NottinghamOutcomes:
Suicide death
Description: Technical Summary
Understanding of suicide risk factors can play a central role in tailoring and the targeting of effective suicide prevention strategies. However, currently recognised risk factors of suicide are far from exhaustive and have not been empirically tested together which can partly explain the poor prediction of suicide. Healthcare registries can offer a valuable source of information for studying suicide risk, and since many suicide victims visited healthcare facilities in their final year, they can be a potential place for recognising risk and for intervening. The aim of this study is to consider several potential risk factors, singly and collectively, to predict suicide risk from health data.
We will examine several potential risk factors which may be recorded in primary or secondary health data, including:
-Demographic characteristics including ethnicity.
-The pattern of and reason for attendance
-Physical health conditions including self-harm.
-Dementia diagnosis and anti-dementia drugs
-Analgesic prescribing, including nonopioids medicationsAs primary and secondary care differ significantly in terms of access, service provision and nature and severity of health conditions managed, we will use the integrated CPRD (for primary care) and Hospital Episode Statistics (for secondary care) databases to help achieve a more holistic understanding of suicide risk factors. For assessing socioeconomic status, linkage with patient Index of Multiple Deprivation will be used. Moreover, we will use linked Office for National Statistics as this improves the validity of identification of suicide death.
We will conduct a population-based case-control study for suicide death. 40 controls will be risk-set sampled for each case. We propose developing (and internally validating) two main types of multivariable regression models and fitting random effects models at the general practice level as appropriate. One type involves examining each main risk factor allowing for confounders and the second involves combining suicide risk factors to predict suicide more accurately.
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A combined cross-sectional and cohort study to describe and quantify polypharmacy among people prescribed antidepressants, including quantifying frequent drug combinations and adverse events — Carol Coupland ...
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A combined cross-sectional and cohort study to describe and quantify polypharmacy among people prescribed antidepressants, including quantifying frequent drug combinations and adverse events
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-11
Organisations:
Carol Coupland - Chief Investigator - University of Nottingham
Rebecca Joseph - Corresponding Applicant - University of Nottingham
Chris Hollis - Collaborator - University of Nottingham
Daniel Lea - Collaborator - University of Nottingham
Debbie Butler - Collaborator - University of Nottingham
Julia Hippisley-Cox - Collaborator - University of Oxford
Richard Morriss - Collaborator - University of Nottingham
Roberto Santos - Collaborator - University of Nottingham
Roger Knaggs - Collaborator - University of Nottingham
Ruth Jack - Collaborator - University of NottinghamOutcomes:
Polypharmacy; all-cause mortality; serotonin syndrome; gastrointestinal bleeding; cerebrovascular bleeding; falls and fractures; overdose; medication reviews
As detailed in "Study Background", serotonin syndrome, gastrointestinal bleeds, and cerebrovascular bleeds are key adverse outcomes associated with antidepressant interactions according to the British National Formulary, and combinations of central nervous system agents including opioids are associated with outcomes such as falls and overdose. These serious outcomes are often fatal, thus mortality is also of interest. Medication reviews were of interest to the patient representatives consulted, as marking the opportunity for patients and prescribers to address polypharmacy.
Description: Technical Summary
Objectives: to describe polypharmacy among patients who are prescribed antidepressants.
Study population: for the main descriptive analyses patients aged 18+ years prescribed an antidepressant in 2019 will be included. To study trends over time, patients prescribed antidepressants in 2009, 2011, 2013, 2015 and 2017 will also be included. To quantify rates of adverse events associated with polypharmacy, patients prescribed antidepressants in 2015 will be followed-up until March 2020.
Polypharmacy: the number of active prescriptions at any one time. The maximum number of medicines prescribed at the same time as an antidepressant in the study years will be determined. Specific combinations of medicines will be defined, including multiple antidepressants, opioids and other central nervous system agents, and âriskyâ combinations.
Patient characteristics: a range of characteristics including demographics, lifestyle characteristics and comorbidities will be defined using primary care data.
Adverse events: serotonin syndrome, gastrointestinal bleeds, cerebrovascular bleeds, falls and fractures, overdose, and death. Other common adverse events will be identified during the study. Linked primary care, Hospital Episode Statistics, and Office for National Statistics mortality data will be used to define these outcomes.
Analyses: summary statistics (median and interquartile range) will be presented for maximum polypharmacy count per patient in each study year. Patient characteristics according to polypharmacy count in 2019 will be tabulated, and exploratory analyses using appropriate regression models (e.g. Poisson regression) will be used to test whether polypharmacy count differs according to patient characteristics. Numbers of patients with medication reviews in 2019 will be counted, and maximum polypharmacy count before and after reviews summarised. The numbers of patients with the specified medicine combinations will be counted. The most common combinations of antidepressants with 2+ other medicines will be found and summarised. Age-sex standardised rates of adverse events occurring while exposed to specified combinations of medicines will be estimated.
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Feasibility analysis of a European infrastructure for COVID-19 vaccine monitoring: Background rates of Adverse Events of Special Interest — Patrick Souverein ...
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Feasibility analysis of a European infrastructure for COVID-19 vaccine monitoring: Background rates of Adverse Events of Special Interest
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-24
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Helga Gardarsdottir - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Romin Pajouheshnia - Collaborator - Utrecht UniversityOutcomes:
Guillain-Barré Syndrome;Acute disseminated encephalomyelitis;Narcolepsy;Acute aseptic arthritis;Diabetes (type 1 and broader);(Idiopathic) Thrombocytopenia; Acute cardiovascular injury(Microangiopathy, Heart failure, Stress cardiomyopathy, Coronary artery disease, Arrhythmia, Myocarditis); Coagulation disorders (Thromboembolism, Hemorrhage); Single Organ Cutaneous Vasculitis; Acute liver injury; Acute kidney injury;Generalized convulsion;Meningoencephalitis;Transverse myelitis; Acute respiratory distress syndrome; Erythema multiforme; Chilblain â like lesions;Anosmia, ageusia;Anaphylaxis;Multisystem inflammatory syndrome in children;Death (any causes);COVID-19 disease (by levels of severity): Level 1: any recorded diagnosis, level 2: hospitalization for COVID-19 (confirmed or suspected), level 3: ICU admission in those with COVID-19 related admission; level 4: Acute respiratory distress requiring ventilation (ARDS) during a hospitalization for COVID-19; level 5 death during a hospitalization for COVID-19 (any cause);Sudden death;Gestational Diabetes; Pre-eclampsia; Maternal death; Fetal growth restriction; Spontaneous abortions;Stillbirth;Preterm birth;Major congenital anomalies;Microcephaly;Neonatal death;Termination Of Pregnancy for Fetal Anomaly; colonic diverticulitis; hypertension
Description: Technical Summary
The global rapid spread of COVID-19 caused by the SARS-CoV2 triggered the need for developing vaccines to control for this pandemic. This study will generate background incidence rates of adverse events of special interest (AESI) that may be used to monitor benefit-risk profile of upcoming COVID-19 vaccines. A retrospective multi-database dynamic cohort study will be conducted over the period 2017 to 2020 using 10 healthcare databases in 7 European countries, including UK CPRD. The study population will include all individuals observed in for at least one day during the study period (01 January 2017 - last data availability) and who have at least 1 year of data availability before cohort entry, except for individuals with data available since birth. Outcomes of interest include 38 different AESI, as defined by relevant Read/Snomed/ICD-10 codes, using both GP and HES data. Person-time of interest in CPRD will be based on the standard relevant patient and practice dates. Several at-risk medical conditions will be used as stratification factors. Incidence rates by calendar year will be calculated by dividing the number of incident cases (not in run-in year) (numerator) by the total person-time at risk (denominator). Prevalence rates by calendar year will be calculated by dividing the number of existing cases in a year (numerator) by the average of the total number of persons recorded monthly (denominator). Incidence rates will also be reported stratified by time prior to SARS-CoV2 circulation and during SARS-CoV2 circulation period to investigate potential changes in health care behaviours during the pandemic and associated lockdown periods on the incidence rates. Incidence rates will also be provided among persons at higher risk for developing severe COVID-19.
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To investigate the prevalence, incidence and mortality for Interstitial Lung Disease (ILD) in the UK for the study period 2009 to 2019 — Jennifer Quint ...
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To investigate the prevalence, incidence and mortality for Interstitial Lung Disease (ILD) in the UK for the study period 2009 to 2019
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-03
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Rikisha Shah Gupta - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Peter George - Collaborator - Royal Brompton HospitalOutcomes:
The primary outcome of this study is to establish the epidemiology of ILD by predefined aetiological subgroups in the UK for the period from 2009 to 2019 defined by incidence, prevalence and all-cause mortality in ILD cohort (overall ILD and its subgroups).
Description: Technical Summary
ILD is an umbrella term which encompasses several conditions with different clinical pathways leading to varied health outcomes. Pharmacological intervention varies depending on the underlying diagnosis, disease severity and trajectory and patient choice. In this study, we will identify an ILD cohort which represents the range of different conditions and use it to estimate the prevalence and incidence of all ILD. Given the heterogenous nature of the conditions and potential inaccuracies in diagnostic coding it is considered likely that reliance on simple lists of clinical diagnostic codes may lead to potential under- and over- ascertainment of cases. For this reason, this research will be conducted in parallel with an ILD code validation study (ID number 20_000068) to assess the reliability of identifying ILD in primary and secondary care data. Further, we plan to stratify the overall ILD cohort by ILD subtypes.
Preliminary literature review demonstrates incidence and prevalence estimates vary by ILD disease type and geography. The current challenges in ILD diagnoses is due to its various entities and added complexity due to lack of understanding. As well, recent papers have reported an increase in the observed overall ILD cases. Whether this is an actual increase in ILD cases or due to improved coding practices through the years is unknown.
We plan to estimate the incidence and prevalence by overall ILD and by its predefined subtypes. We will also estimate and all-cause mortality in overall ILD cohort and its sub groups.
To comprehend the seriousness of ILD burden in the UK, we aim to enhance ILD evidence using CPRD-HES APC-ONS linked data. We hope that this research will generate epidemiological evidence to fill in the current evidence gaps in the UK.
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Development of an algorithm to identify Hypereosinophilic Syndrome using the Clinical Practice Research Datalink linked with hospital data — Gema Requena ...
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Development of an algorithm to identify Hypereosinophilic Syndrome using the Clinical Practice Research Datalink linked with hospital data
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-03
Organisations:
Gema Requena - Chief Investigator - GlaxoSmithKline - UK
Gema Requena - Corresponding Applicant - GlaxoSmithKline - UK
Nicholas Galwey - Collaborator - GSK
Rupert Jakes - Collaborator - GlaxoSmithKline - UK
Sandra Joksaite - Collaborator - GlaxoSmithKline - UKOutcomes:
Diagnoses, laboratory results and treatments used among patients with specific READ/SNOMED/EMIS codes for HES (âHESâ reference population); Positive Predictive Value (PPV); Negative Predictive Value (NPV); sensitivity and specificity.
Description: Technical Summary
Hypereosinophilic syndrome (HES) is a very rare disease, characterised by a marked eosinophilia sustained over time that may cause organ damage and/or dysfunction. Patients with HES in the UKâs Clinical Practice Research Datalink (CPRD) database can be characterised using a specific READ/SNOMED/EMIS diagnostic code. However, other databases, such as those that use the international classification of diseases, version 10 (ICD10), lack a specific code for HES, though a general term of âeosinophiliaâ (D72.1) exists. We want to recognise HES disease in patients in these other databases. To do this, we will find and characterise patients with the existing HES code in the CPRD Aurum database linked with hospital records, as the reference population. Then, by using a combination of ICD-10 codes, laboratory tests and medication codes, we aim to develop an algorithm that could be used in other databases to characterise these patients.
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European non-interventional post-authorisation safety study (PASS) related to serious infections associated to romosozumab by the EU-ADR Alliance — Alireza Moayyeri ...
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European non-interventional post-authorisation safety study (PASS) related to serious infections associated to romosozumab by the EU-ADR Alliance
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-11
Organisations:
Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Annika Jodicke - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Chao Lu - Collaborator - UCB BioSciences, Inc.
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Maria Sanchez - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Primary: Serious infection leading to hospitalisation
Secondary: Death due to serious infectionDescription: Technical Summary
Objective
The aim of this study is to characterise the risk of serious infections associated with the use of romosozumab, in comparison with other available osteoporosis medications in routine clinical practice in the UK as part of a study of 7 databases from Europe. This will be achieved by meeting three objectives: 1) assessing the incidence of serious infections in romosozumab patients and in patients using other osteoporosis medications; 2) assessing the incidence of serious infections in romosozumab users and amongst users of other osteoporosis medications, stratified by age, previous use of osteoporosis medications, and by prespecified key risk factors for serious infections; and 3) assess the comparative risk of serious infections between patients using romosozumab and alendronate.
Population
The population for this study is women aged 50+ with severe osteoporosis who are prescribed one of the below osteoporotic medications. Severe osteoporosis is identified by the presence of 1 or more fractures of any skeletal sites except face/skull/digit/s fractures recorded in the year prior to therapy initiation.
Exposure
The exposure of interest is romosozumab. Comparator exposures are alendronate (primary comparator); ibandronate (oral and intravenous), risedronate, zoledronate; denosumab; and teriparatide.
Outcome
The primary outcome of interest is serious infection leading to hospitalisation whilst the secondary outcome is death due to serious infection.
Methods
This will be designed using a cohort study with incidence rates of each outcome for each osteoporosis medication calculated using a Poisson model. Meanwhile, Cox proportional hazards with propensity score matching will be used for the comparative risk assessment. Multiple sensitivity analyses including negative control outcomes, self-controlled case series (SCCS), and instrumental variable analysis will be undertaken to assess the results for confounding.
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Acute and long-term health outcomes for people who survived COVID-19: matched cohort analyses using UK primary and secondary care data — Kevin Wing ...
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Acute and long-term health outcomes for people who survived COVID-19: matched cohort analyses using UK primary and secondary care data
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-10
Organisations:
Kevin Wing - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amy Mulick - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Catherine Houlihan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Eliana Lacerda - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeremy Brown - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathleen Mudie - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ketaki Bhate - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Luigi Palla - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Luis Nacul - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sharon Cadogan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
1. Mortality: all-cause and cause-specific (with specific-causes being those related to the other outcomes in this list, plus any additional causes listed in the ONS record for people who die following recovery from COVID-19 during the study period)
2. Multimorbidity and healthcare utilisation: Hospital (re)admission, GP consultation frequency, multimorbidity
3. Respiratory conditions: pulmonary fibrosis, pulmonary hypertension, pulmonary embolism, obstructive lung disease
4. Cardiovascular disease: venous thromboembolism, stroke, myocardial infarction, heart failure, major arrhythmias
5. Adverse renal outcomes: acute kidney injury, chronic kidney disease (incident and progression of), dialysis onset, proteinuria
6. Adverse hepatic outcomes: acute liver injury, chronic liver disease
7. Myalgic Encephalomyelitis/Chronic fatigue syndrome/ (ME/CFS), fibromyalgia
8. Neurological/cognitive conditions: anosmia, Guillian Barré syndrome, peripheral neuropathy, acute cognitive impairment (e.g deliruium), chronic mild cognitive impairment, dementia, seizures, epilepsy
9. Mental health conditions: PTSD, depression, sleep disorders, suicide (attempt and completed), anxiety-related disorders, self-harm, alcohol abuse
10. Autoimmune conditions: rheumatoid arthritis
11. Frailty (for survivors aged >=65 years)Description: Technical Summary
There have been over 8 million cases worldwide of COVID-19 due to SARS-CoV-2 infection. With a case-fatality of around 1%, the number of people who survive is set to increase substantially as the pandemic progresses. It is currently not known what the short- or long-term effects of SARS-CoV-2 infection are on those who survive, but clinical features of the condition and existing evidence from the SARS (SARS-CoV-1) pandemic suggest the potential for a range of debilitating post-viral conditions. As over 300 000 have had or currently have COVID-19 (based upon UK Government Pillar 1 test results) and this figure is likely to rise, there is an urgent need to assess and to quantify short and long-term health for people in the UK who survive COVID-19. This information will assist patients and their carers and will inform NHS health service planning.
Using two study populations - (a) people who have been admitted to hospital due to COVID-19 (i.e. have severe disease) and (b) people who have COVID-19 but are not admitted to hospital (i.e. have milder disease) - we plan to perform a matched cohort study in which the unexposed are people with no record of COVID-19.We will measure frequency of mortality and a range of key respiratory, neurological, cardiovascular, renal, hepatic, mental health and autoimmune outcomes. Analysis will be performed during the 3-month period after index date and at 4 subsequent time points (6 months,1 year, 3 years and 5 years after index date), and at each timepoint we will look at whether effects differ by age, ethnicity, sex, prior chronic illness and prior drug treatment. Each individual will be matched by age, sex, general practice and charlson comorbidiy index to individuals with no record of having COVID-19, and the time-to-first event for each outcome will be compared between groups. We will also use multivariable ordinal logistic and linear regression to analyse the effect of previous COVID-19 on frailty in survivors >=65 years of age.
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Who benefits and who suffers harm from discontinuation of renin-angiotensin-aldosterone system inhibitors? A regression discontinuity study — Till Bärnighausen ...
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Who benefits and who suffers harm from discontinuation of renin-angiotensin-aldosterone system inhibitors? A regression discontinuity study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-25
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Min Xie - Corresponding Applicant - University Hospital Heidelberg
Anant Jani - Collaborator - University of Surrey
Christian Bommer - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität Göttingen
Simon Sawhney - Collaborator - University of AberdeenOutcomes:
Primary outcomes:
To be analysed after one year and five years from RAAS inhibitors cessation:
- frequency of all-cause emergency hospitalizations
- frequency of major adverse cardiovascular or kidney events (any of the following: heart failure, myocardial infarction event, stroke, dialysis, estimated GFR<15, or estimated GFR drop by 40% and more)
- frequency of adverse safety events (any of the following: recurrent hyperkalemia, AKI, or worsening of proteinuria
To be analysed after five years and ten years from RAAS inhibitors cessation:
- all-cause mortalitySecondary outcomes:
To be analysed after 3 months, one year and five years from RAAS inhibitors cessation:
- frequency of all-cause hospitalizations
- frequency of severe adverse health events (analyse of the following separately heart failure, myocardial infarction event, stroke, dialysis, estimated GFR<15, or estimated GFR drop by 40% and more, recurrent hyperkalemia, AKI, or worsening of proteinuria)
To be analysed after five years and ten years from RAAS inhibitors cessation:
- mortality of renal or cardiac causeDescription: Technical Summary
Previous studies investigating the health effects of RAAS inhibitors therapy administered to patients are largely limited to controlled clinical trials. While these studies have pointed towards the efficacy of RAAS inhibitors therapy in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Non-experimental studies, in contrast, may fail to establish causality due to insufficient control of confounding factors. This study seeks to measure the effects of RAAS inhibitors therapy on short-, mid-, and long-term clinical outcomes (mortality, hospitalizations, major adverse cardiac and kidney events) and safety outcomes (recurrent hyperkalemia and acute kidney injury (AKI)) in a routine care set-up for patients who just started the RAAS inhibitors therapy. We will also measure the effects for different sample splits, including men and women of various age groups, with and without diabetes, with or without heart failure, ethnicity and from different socio-economic backgrounds. To establish causality, we make use of a regression discontinuity (RD) design taking advantage of a major UK clinical guideline, which recommends ceasing RAAS inhibitors therapy based on threshold rules related to patientsâ serum potassium levels (as the use of RAAS inhibitors can also increase serum potassium and the risk of hyperkalemia). Because physicians base their treatment decisions on additional considerations besides clinical guidelines, we use an instrumental variable approach that is robust to partial compliance. We evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with serum potassium levels increasingly close to the treatment threshold level. The findings of this study are expected to provide novel insights into the effectiveness of RAAS inhibitors therapy in a real-life setting and can directly inform clinical practice.
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Cardiometabolic disease prediction using general practice consultation pattern: Use of Machine Learning (ML) — Bhautesh Jani ...
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Cardiometabolic disease prediction using general practice consultation pattern: Use of Machine Learning (ML)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-02
Organisations:
Bhautesh Jani - Chief Investigator - University of Glasgow
Bhautesh Jani - Corresponding Applicant - University of Glasgow
Ahmed Zoha - Collaborator - University of Glasgow
Ahsen Tahir - Collaborator - University of Glasgow
Barbara Nicholl - Collaborator - University of Glasgow
Christian Delles - Collaborator - University of Glasgow
Claudia Geue - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
Desmond Campbell - Collaborator - University of Glasgow
Donald Lyall - Collaborator - University of Glasgow
Frances Mair - Collaborator - University of Glasgow
Frederick Ho - Collaborator - University of Glasgow
Giorgio Ciminata - Collaborator - University of Glasgow
Hasan Abbas - Collaborator - University of Glasgow
Jennifer Lees - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Jim Lewsey - Collaborator - University of Glasgow
Kia Dashtipour - Collaborator - University of Glasgow
Michael Sullivan - Collaborator - University of Glasgow
Muhammad Aurangzeb Khan - Collaborator - University of Glasgow
Naveed Sattar - Collaborator - University of Glasgow
Patrick Mark - Collaborator - University of Glasgow
Qammer Abbasi - Collaborator - University of Glasgow
Septiara Putri - Collaborator - University of Glasgow
Srinivasa Vittal Katikireddi - Collaborator - University of GlasgowOutcomes:
Primary Outcomes
Incidence of Atrial Fibrillation
Incidence of Diabetes
Incidence of Coronary Heart Disease
Incidence of Heart Failure
Incidence of Stroke (ischaemic and haemorrhagic)
Incidence of Vascular Dementia
Incidence of Chronic Kidney Disease
Incidence of HypertensionSecondary Outcomes
Development of other cardiometabolic conditions after developing one of the eight conditions described above
All-cause mortality
Cardiovascular mortalityDescription: Technical Summary
Cardiometabolic disease is a broad umbrella term often used to describe a cluster of conditions (diabetes, hypertension, CHD, atrial fibrillation (AF), heart failure (HF), stroke, chronic kidney disease (CKD) and vascular dementia) with shared risk factors. Cardiovascular disease is a leading cause of death in the UK, especially among those with diabetes (1). There is a growing interest in primary prevention of cardiometabolic disease by early identification and risk assessment, thereby reducing the health burden associated with cardiometabolic diseases.
Machine Learning (ML) is the practice of using algorithms to parse data, learn from it, and then make a determination or prediction about something in the world. We propose to apply various machine learning methods to general practice records available in CPRD to develop algorithms for risk prediction of incident cardiometabolic diseases. We will consider eight different cardiometabolic diseases as primary outcomes: diabetes, CHD, atrial fibrillation (AF), heart failure (HF), stroke, vascular dementia, hypertension and chronic kidney disease. We will use following classes of machine learning algorithms: 1. support vector machines (linear and non-linear), 2. penalised logistic regression, 3. boosting ensemble methods, 4. tree-based ensemble methods and 5. neural network approaches. We will use internal cross-validation with various performance measures to evaluate the accuracy of prediction models derived from different ML approaches. We will compare the risk prediction models developed from this work to existing models for cardiovascular risk prediction (e.g. Framingham scores https://www.framinghamheartstudy.org/fhs-risk-functions/ and Q risk scores https://www.qresearch.org/ ) where applicable.In addition, we will derive transition probabilities to be used in a transition modelling framework involving first âcompetingâ cardiometabolic events and secondary events states with most complications and associated costs; estimate life expectancies and quality adjusted life expectancies. These will form the basis of a web-application tool for decision-making.
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Effectiveness of primary care COPD management in the UK: a regression discontinuity design — Till Bärnighausen ...
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Effectiveness of primary care COPD management in the UK: a regression discontinuity design
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-11-23
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Dominik Jockers - Corresponding Applicant - University Hospital Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
Primary outcomes (all to be measured over time horizons of six months, one year, three years, five, and ten years):
COPD exacerbations (bronchitis and chest infections for not yet diagnosed patients); frequencies and severity of incidents; hospitalizations related to COPD and likely COPD exacerbations; smoking cessation (among smokers); all-cause mortality; mortality related to COPD (Respiratory and heart failure)Description: Technical Summary
This study seeks to measure the effect of primary care COPD management on short-, mid-, and long-term clinical outcomes (progression of COPD, exacerbations, mortality, emergency hospitalizations, major adverse health events) in a routine care set-up for adult men and adult women. To establish causality, we make use of a regression discontinuity (RD) design taking advantage of public health guidelines on confirming a COPD diagnosis by a FEV1/FVC ratio lung function test. Following a COPD diagnosis, disease management is done by GPs. Because physicians base their diagnosis decisions on additional considerations besides public health thresholds, we use an instrumental variable approach that is robust to partial compliance. We evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with FEV1/FVC ratios increasingly close to the treatment threshold level. In addition, we will test for heterogenous treatment effects by stratifying our sample by medication applied, sex, age, ethnicity, socioeconomic status, urban vs rural place of residence, and comorbidities. The findings of this study are expected to provide novel insights into the effectiveness COPD management in a real-life setting and can directly inform clinical practice.
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ID 95: De-identified Data Access Request: To improve health and care services and reduce health inequalities in the UK — Imperial College Health Partners...
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ID 95: De-identified Data Access Request: To improve health and care services and reduce health inequalities in the UK
Legal basis:Healthcare Planning
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Nov-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Mental health.
Source
2020 - 10
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Administrative Data | Agricultural Research Collection: Enhancing the prosperity and wellbeing of farm households — unknown...
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Administrative Data | Agricultural Research Collection: Enhancing the prosperity and wellbeing of farm households
Where: unstated
When: 2020-10-2
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is working in partnership with a group of academic and government bodies to link de-identified data from across the UK to create the first UK-wide data platform focused on agriculture.
Farming in the UK underpins the nationâs food security, generates economic benefits and shapes a rich and varied landscape. Likewise, farm households, residing in the same location often over many generations, are important local actors, strengthening the social fabric of rural areas.
Despite these contributions to local and national life, farming as a sector experiences uncertain and volatile profits with consequences for household income and financial stability. In recognition of these and other features of farming life, agriculture has received subsidies aimed at supporting and stabilising farm incomes, encouraging environmental actions and diversifying farm business activities.
For almost 40 years, policy was largely delivered through the EU Common Agricultural Policy (CAP), but following Brexit, authority has returned to the UK. As agriculture is a devolved matter, this means new and increased responsibilities for all four UK nations. New policy directions are already being established with aims linked to improving business prosperity, enhancing environmental sustainability and strengthening business and personal resilience.
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EU Settlement Scheme Data Linking Project — unknown...
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EU Settlement Scheme Data Linking Project
Where: unstated
When: 2020-10-9
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
The EU Settlement Scheme (EUSS) Data Linking Project is an ADR Wales initiative born out of the need to improve the evidence base on EU citizens in Wales who are part of the EU Settlement Scheme.
It aims to anonymously link Home Office data with other data already held within the SAIL Databank, enabling researchers and policymakers to better understand the experiences of EU citizens with Settled Status, and therefore to develop better informed policy and services that address the needs of this potentially vulnerable population.
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COVID-19 at-risk Patients data
GPES Data for Pandemic Planning & Research
Hospital Episode Statistics (Identifiable) (Direct Care and Secondary Uses) — NHS England...
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NHS England has commissioned NHS South West and Central CSU (which is part of NHS England) to implement a National Immunisation Management Service (NIMS). The implementation of this service will deliver a centralised service for the management of seasonal flu immunisation and is an essential component of NHS Englandâs response to the COVID-19 pandemic. This is because 1.it will help to ensure that any second âspikeâ in coronavirus infections in England separated in time as far as possible from the annual flu epidemic â so minimising pressures on NHS resources 2.it will provide a protype for the delivery of a subsequent national COVID-19 immunisation programme by establishing a dynamic infrastructure capable of responding rapidly to target appropriate cohorts across the whole population of England. It is essential that the two programmes are coordinated to accommodate the developing characteristics of the pandemic, and any interfaces between the vaccines, and their delivery processes as they are established. The purpose of the dissemination is to support the following: 1.national call/recall for influenza; and 2.national call/recall for COVID-19 vaccination. NHS England has confirmed that details of all patients registered with practices in England is required in support of this service. — IG-00978_3
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 01/10/2020
Purpose for which the data is being used: NHS England has commissioned NHS South West and Central CSU (which is part of NHS England) to implement a National Immunisation Management Service (NIMS). The implementation of this service will deliver a centralised service for the management of seasonal flu immunisation and is an essential component of NHS Englandâs response to the COVID-19 pandemic. This is because 1.it will help to ensure that any second âspikeâ in coronavirus infections in England separated in time as far as possible from the annual flu epidemic â so minimising pressures on NHS resources 2.it will provide a protype for the delivery of a subsequent national COVID-19 immunisation programme by establishing a dynamic infrastructure capable of responding rapidly to target appropriate cohorts across the whole population of England. It is essential that the two programmes are coordinated to accommodate the developing characteristics of the pandemic, and any interfaces between the vaccines, and their delivery processes as they are established. The purpose of the dissemination is to support the following: 1.national call/recall for influenza; and 2.national call/recall for COVID-19 vaccination. NHS England has confirmed that details of all patients registered with practices in England is required in support of this service.
Dataset: COVID-19 at-risk Patients data GPES Data for Pandemic Planning & Research Hospital Episode Statistics
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care and Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: Direct Care â implied consent Secondary Uses â legal obligation
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: Direct Care â implied consent Secondary Uses â legal obligation
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Mid-Year 2020-21 Adult Social Care Activity Data Set (Aggregate (small numbers supressed)) (Secondary Uses) — Adult Social Care Data and Outcomes Board (DOB)...
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To understand the impact of COVID-19 and facilitate strategic planning regarding the impacts of the virus on services. — IG-00701
Recipient Data Controller Organisation(s) : Adult Social Care Data and Outcomes Board (DOB)
Approval Date: 06/10/2020
Purpose for which the data is being used: To understand the impact of COVID-19 and facilitate strategic planning regarding the impacts of the virus on services.
Dataset: Mid-Year 2020-21 Adult Social Care Activity Data Set
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
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Permission To Contact data (Aggregate (small numbers supressed)) (Secondary Uses) — National Institute for Health Research (NIHR) identified researchers working on UK...
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To enable researchers to plan their vaccine trials by querying numbers for potential volunteer cohorts and to monitor geographic and equality analyses of the volunteers to plan potential national / local communications actions to promote sign-up by under-represented groups. — IG-01240
Recipient Data Controller Organisation(s) : National Institute for Health Research (NIHR) identified researchers working on UK-accredited studies for Covid-19 vaccine studies National Institute for Health Research (NIHR) Department of Health and Social Care (DHSC) UK Vaccines Task Force members
Approval Date: 20/10/2020
Purpose for which the data is being used: To enable researchers to plan their vaccine trials by querying numbers for potential volunteer cohorts and to monitor geographic and equality analyses of the volunteers to plan potential national / local communications actions to promote sign-up by under-represented groups.
Dataset: Permission To Contact data
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â the national data opt-out does not apply as the data is all provided directly by the individual and they have given their consent for its use.
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The impact of painful musculoskeletal conditions on outcomes of cardiovascular disease — Kelvin Jordan ...
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The impact of painful musculoskeletal conditions on outcomes of cardiovascular disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-14
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Alyson Huntley - Collaborator - University of Bristol
Christian Mallen - Collaborator - Keele University
Felix Achana - Collaborator - University of Oxford
Felix Achana - Collaborator - University of Oxford
James Bailey - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Kayleigh Mason - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Martin Frisher - Collaborator - Keele University
May Ee Png - Collaborator - University of Oxford
Michelle Marshall - Collaborator - Keele University
Neil Heron - Collaborator - Keele University
Simon White - Collaborator - Keele UniversityOutcomes:
i) Length of stay in hospital based on admission and discharge dates recorded in HES;
ii) Readmission to hospital within 30 days of discharge for the same reason as initial hospitalisation;
iii) Readmission to hospital within 30 days of discharge for different reason to initial hospitalisation;
iv) (time to) Mortality based on recorded information in linked ONS data;
v) Progression of disease defined as a further ACS/stroke;
vi) Management of index condition based on procedures recorded in HES during the hospital stay and prescriptions recorded in primary care in the three months following index date. This will include angiography, percutaneous coronary intervention and coronary artery bypass graft, and prescription of dual antiplatelet therapy, beta blockers and ACE inhibiters and angiotensin receptor blockers for ACS; thrombolysis or thrombectomy, and prescription of antiplatelets or anticoagulants for stroke;
vii) Cumulative health care use and costs over 5 years after index date. Primary care data will include number, type and length of consultations with each health care professional, prescriptions, tests and investigations. Secondary care utilisation includes referral, type of admission, length of stay, diagnosis, and procedures undertaken.Description: Technical Summary
In people with long-term conditions such as stroke or acute coronary syndrome (ACS), comorbid musculoskeletal pain is common but often neglected. Musculoskeletal comorbidity could adversely impact outcomes if pain, and associated restricted functioning and sleep interference, prevent or delay delivery of appropriate treatment or reduce its effectiveness, and extend time in hospital. Our previous analysis of CPRD GOLD (ISAC 19_025) suggested patients with recent musculoskeletal health care had a longer hospital stay for ACS and increased rates of readmission within 30 days. We will validate these findings in Aurum and extend analyses to assess the relationship of musculoskeletal pain with management and longer-term outcomes of ACS/stroke. Using CPRD Aurum, we will analyse data of patients newly diagnosed with ACS/stroke and compare patients with a prior painful musculoskeletal condition requiring health care to patients without on in-hospital intervention (thrombolysis or thrombectomy for stroke, coronary angiography, percutaneous coronary intervention or coronary artery bypass graft for ACS), pharmacological management, length of hospital stay, 30 day readmission, and long term outcomes including further ACS or stroke, mortality, and resource use. Painful musculoskeletal conditions will be identified from primary care records in the 24-months prior to admission for ACS/stroke. Poisson regression will be used to determine differences in hospital length of stay. Flexible parametric survival models will be used for time to event outcomes (e.g. mortality). We will assess if impact varies by time of most recent musculoskeletal consultation or pain severity (proxy measures of musculoskeletal referral, analgesia prescription). We will determine if inequalities exist in these relationships by socioeconomic characteristics (age, ethnicity, deprivation, geographical region), and if relationships differ by type of painful musculoskeletal condition. Our findings will allow assessment of potential for existing evidence-based management of musculoskeletal pain and associated disability to be targeted at patients to improve outcomes following admission with ACS/stroke.
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Proposal to develop an algorithm to link mothers to their children in CPRD Aurum — Susan Jick ...
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Proposal to develop an algorithm to link mothers to their children in CPRD Aurum
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-28
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Eleanor Yelland - Collaborator - CPRD
Jennifer Campbell - Collaborator - CPRD
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Puja Myles - Collaborator - CPRD
Rachael Williams - Collaborator - CPRD
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Linkage of mothers to their children in CPRD Aurum through development of a mother-baby linkage algorithm.
Description: Technical Summary
This is a descriptive feasibility study of delivery and birth codes recorded in CPRD Aurum to assess the feasibility to link mothers with their children in CPRD Aurum.
We will select two cohorts of patients from a sample of 100 CPRD Aurum practices: 1) women of childbearing age in CPRD Aurum, defined as women aged 12 to 49 years old who have a Medcode that indicates pregnancy or delivery any time after their recorded start date, and 2) all patients in CPRD Aurum whose recorded start date was within the first year of life (i.e. baby). We will then develop an algorithm using practice ID and family ID to match women of childbearing age to their children using delivery/ and birth Medcodes. All matches will be scored according to the level of matching (e.g. exact delivery / birth Medcode date match, same month and year match, same year match) to provide a level of confidence in the match. We will test the algorithm by reviewing the electronic records of a sample of mothers and their matched children. Once the algorithm has been developed and tested it will be shared with CPRD for implementation of a mother-baby link in the entire CPRD Aurum database so that it can benefit public health surveillance and the wider research community.
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Second-line combined treatment with metformin and DPP-4 inhibitors in type 2 diabetes and risk of major cardiovascular events, cardiovascular and all-cause mortality: a prevalent new-user cohort study — Wolfgang Rathmann ...
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Second-line combined treatment with metformin and DPP-4 inhibitors in type 2 diabetes and risk of major cardiovascular events, cardiovascular and all-cause mortality: a prevalent new-user cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-14
Organisations:
Wolfgang Rathmann - Chief Investigator - University of Dusseldorf
Brenda Bongaerts - Corresponding Applicant - University of Dusseldorf
Oliver Kuss - Collaborator - University of DusseldorfOutcomes:
(i) MACE (major adverse cardiac event): a composite outcome of acute myocardial infarction (AMI), stroke (ischemic or haemorrhagic) and cardiovascular mortality; (ii) cardiovascular mortality; and (iii) all-cause mortality.
Description: Technical Summary
Previous randomized controlled metabolic outcome trials could show that dipeptidyl peptidase-4 (DPP-4) inhibitors were associated with a lower risk of major adverse cardiovascular events and Âdeath in type 2 diabetes. Recent randomized cardiovascular safety trials, on the other hand, found no beneficial cardiovascular effects of DDP-4 inhibitors, rendering the current scientific evidence inconclusive. Large real-world observational studies can prove a valuable addition to clinical trials to gain insights into long-term cardiovascular outcomes. We therefore aim to study the comparative safety of combined treatment of metformin and DPP-4 inhibitors versus metformin monotherapy with respect to major cardiovascular events and cardiovascular mortality in type 2 diabetes patients using the CPRD database.
The study will use a prevalent new-user design. From a base cohort of new users of metformin monotherapy between January 2008 and January 2017, the study cohort will be formed by all patients who added a DPP-4 inhibitor. These patients will subsequently be matched to those who remained on metformin monotherapy. Both exposure groups will be followed for the incidence of major adverse cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) until January 2020. Cox proportional hazards models will be fitted for each outcome measure to estimate hazard ratios and 95% confidence intervals for metformin and DPP-4 inhibitor combination therapy versus metformin monotherapy.
By means of the study´s design, elaborate matching, calculation of a propensity score and subsequent overlap weighting we aim to minimize baseline imbalances between exposure groups, as well as the chance for several forms of time-related biases. Multiple sensitivity analyses are planned to assess the robustness of the main analysis.
With maximum efforts to minimize all possible forms of bias, the current study, using real-world patient data, will complement randomized clinical trial evidence on cardiovascular effects of DPP-4 inhibitors and have the potential to influence clinical decision making.
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Near real time vaccine safety monitoring for COVID-19 vaccines — Katherine Donegan ...
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Near real time vaccine safety monitoring for COVID-19 vaccines
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-18
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRA
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jenny Wong - Collaborator - MHRA
Nick Andrews - Collaborator - Public Health England
Philip Bryan - Collaborator - MHRAOutcomes:
Incidence of AESI. The pre-defined list of AESI is:
Sudden death (all ages, including SIDS in infants); Guillain-Barré syndrome, and other peripheral and polyneuropathies; Multiple sclerosis, and other demyelinating disorders; Optic neuritis; Encephalitis (including acute disseminated encephalomyelitis); Myasthenia gravis; Bellâs palsy; Seizure disorders (including febrile); Myocardial infarction; Myo/pericarditis; Stroke and other cerebrovascular events; Idiopathic thrombocytopenic purpura, autoimmune thrombocytopenia; Rheumatoid arthritis, polyarthritis; Autoimmune thyroiditis; Kawasaki syndrome (Paediatric multisystem inflammatory syndrome temporally associated with COVID-19)
AESI code lists are presented in Annex 1.
Note, that this list may be added to depending on emerging safety data from COVID-19 vaccine phase III trials or other source post-licensure.
Absolute exposure to a COVID-19 vaccine will also be an outcome of interest.
Description: Technical Summary
Sequential tests have been applied within longitudinal patient records for the timely detection of safety signals related to vaccines in the US. The purpose of this approach is to allow repeated interrogation of the data, starting immediately after the vaccine is introduced and adjusting for multiple analyses, in order to rapidly detect any increases in risk for pre-identified adverse events of special interest (AESI) potentially associated with vaccination. The feasibility of conducting these analyses has been previously explored in the CPRD. In brief, this active monitoring approach uses repeated application of the Maximised Sequential Probability Ratio Test (MaxSPRT) at pre-defined time points to assess the rate of pre-identified AESI compared to a control. A signal is triggered if the relative risk crosses a pre-defined threshold. AESIs are prospectively identified based on clinical trial data, experience with other vaccines, and knowledge on events that occur naturally in the target population and which may be reported in temporal association with vaccination. Several potential COVID-19 vaccines are in development and once one or several are available deployment across a large population could be very rapid. Following introduction, these sequential methods will be implemented for a full range of AESI. This will allow the size of the evidence base on vaccine safety to grow from first use and in line with the exposed population. These methods will be implemented as part of the UK regulatory portfolio of COVID-19 vaccine vigilance activities. The totality of the data will be used to support communications on the safety of the vaccine to mitigate unfounded safety scares, which can be triggered by small numbers of serious unexpected events, and to rapidly detect any true rare risks should they occur informing the need for changes to the vaccination programme to ensure safety if necessary.
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Which patient groups benefit from statins? A regression discontinuity study — Till Bärnighausen ...
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Which patient groups benefit from statins? A regression discontinuity study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-13
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Christian Bommer - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Duy Do - Collaborator - University of Heidelberg
Julia Lemp - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
Primary outcomes (all to be measured over time horizons of one year, five years, ten years, and 15 years): number of all-cause emergency hospitalizations; number of severe adverse health events (stroke, heart attack, type 2 diabetes, rhabdomyolysis, autoimmune myopathy, dementia  each event type evaluated separately); all-cause mortality
Secondary outcomes (all to be measured over time horizons of one year, five years, ten years, and 15 years): probability of at least one all-cause emergency hospitalization; number of all-cause hospitalizations; probability of at least one all-cause hospitalization; number of hospitalizations due to heart attacks and strokes; probability of at least one hospitalization due to heart attack or stroke; probability of at least one severe adverse health event (as listed under primary outcomes); mortality due to stroke or heart attack; potential side effects of statins (explorative, in addition to the adverse events listed under primary outcomes)
Description: Technical Summary
Previous studies investigating the health effects of statin therapy administered to patients with high cholesterol levels are largely limited to controlled clinical trials. While these studies have pointed towards the efficacy of statin therapy in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Non-experimental studies, in contrast, may fail to establish causality due to insufficient control of confounding factors. This study seeks to measure the effect of statin therapy on short-, mid-, and long-term clinical outcomes (mortality, hospitalizations, major adverse health events) in a routine care set-up for adult men and adult women of various age groups. To establish causality, we make use of a regression discontinuity (RD) design taking advantage of major UK clinical guidelines recommending statin therapy based on threshold rules related to patients cardiovascular disease (CVD) risk scores. Because physicians base their treatment decisions on additional considerations besides CVD risk, we use an instrumental variable approach that is robust to partial compliance. We evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with CVD risk scores increasingly close to the treatment threshold level. The findings of this study are expected to provide novel insights into the effectiveness of statin therapy in a real-life setting and can directly inform clinical practice.
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Application of machine learning algorithms on electronic health records to examine patterns of disease clustering and trajectories — Kazem Rahimi ...
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Application of machine learning algorithms on electronic health records to examine patterns of disease clustering and trajectories
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-26
Organisations:
Kazem Rahimi - Chief Investigator - The George Institute for Global Health
Dexter Canoy - Corresponding Applicant - The George Institute for Global Health
Abdelaali Hassaine - Collaborator - University of Oxford
Mohammad Mamouei - Collaborator - University of Oxford
Rema Ramakrishnan - Collaborator - University of Oxford
Shishir Rao - Collaborator - University of Oxford
Yikuan Li - Collaborator - University of Oxford
Yutong Cai - Collaborator - University of OxfordOutcomes:
In this proposal (Phase 1), we will be looking into developing machine learning methods to identify disease clusters and their trajectories. We will characterise co-occurrences of chronic diseases / long-term conditions some of which we have previously identified as of clinical importance in the UK and from the criteria set by relevant clinical guidelines.
Description: Technical Summary
Phenotyping (characterisation of individuals with specific features of interest such as exposure to risk factor of interest, health outcome, or target variable) is an important step in electronic health records (EHR)-based research. Building on our previous work and expertise, we aim to analyse EHR to gain a better understanding of evolving patterns of multimorbidity and define Âhigh-throughput phenotyping based on machine learning methods. We will study patients aged ?16 years with primary health care data with linkage to other administrative databases, such as Hospital Episode Statistics (HES) and mortality, to capture patients health care journey. The purpose of this two-stage study is to use the Clinical Practice Research Datalink (CPRD) to tackle methodological challenges of a dynamic framework for efficient and scalable phenotyping, describe and characterise disease clusters and trajectories in the population, explore the nature of the associations between diseases in poorly understood disease clusters and their underlying determinants, examine consequences of multimorbidity, and provide estimates for uncertainty on these risk associations. By means of machine learning methods we will conduct valid, accurate and reliable phenotyping, which could improve accuracy of predictive modelling. Through the application of state-of-the-art machine-learning approaches that capture complex temporal disease interactions, we will identify and describe disease clusters and trajectories (Phase 1). By taking account of the entire disease trajectory of individuals, we will assess health impact and survival associated with disease clusters identified through the data-driven methodology (Phase 2  separate protocol) using conventional statistical methods to analyse survival and longitudinal data. Through stepwise elimination of spurious disease-disease interactions and application of multiple methods, we will work towards developing models to aid in the identification of likely causal links and explanatory factors particularly for less well-understood disease cluster associations.
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Metformin, lifestyle advice, and risk of Type 2 Diabetes Mellitus. A comparative effectiveness cohort study in older prediabetic patients, in the Clinical Practice Research Practice AURUM — Caroline Foch ...
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Metformin, lifestyle advice, and risk of Type 2 Diabetes Mellitus. A comparative effectiveness cohort study in older prediabetic patients, in the Clinical Practice Research Practice AURUM
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-04
Organisations:
Caroline Foch - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Caroline Foch - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Emmanuelle Boutmy - Collaborator - Merck Healthcare KGaA (Merck Group)
Michael Batech - Collaborator - Merck Healthcare KGaA (Merck Group)
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)
Ulrike Gottwald-Hostalek - Collaborator - Merck Healthcare KGaA (Merck Group)Outcomes:
Type 2 diabetes mellitus; conversion to normo-glycemia; hospitalization for myocardial infarction; hospitalization for stroke; hospitalization for heart failure; chronic kidney disease; all-cause death.
Description: Technical Summary
This study will focus on patients above 60 years-old at high risk of diabetes due to elevated blood glucose, namely prediabetic patients. More especially, it will compare prediabetic patients that initiate metformin on top of lifestyle advice (MET+LSA), as opposed to prediabetic patients that have carried on lifestyle advice (LSA) only.
Both cohorts will be compared in terms of risk of type 2 diabetes mellitus, hospitalization for myocardial infarction, hospitalization for heart failure, hospitalization for stroke, chronic kidney disease, death, and rate of conversion to normo-glycaemia. Hospital Episode Statistics data will be used to determine the outcomes related to the hospitalisations, the Office for National Statistics for death status, and CPRD Aurum for the other outcomes.
The study design is based on a parent cohort of patients above 60 years-old, newly diagnosed with prediabetes encompassing: one cohort of patients initiating MET+LSA (new users) matched to one cohort of patients carrying on LSA only (prevalent). Starting from the prediabetes diagnosis, time-based exposure sets will be defined. The time based exposure will provide time points in the disease course at which confounder patient characteristics will be measured. To be eligible in a specific time risk set, patients will be required to have a medical visit. At each time-based exposure set patients a time-conditional propensity score will be assessed. It will compute the propensity of initiating MET+LSA, versus carrying on LSA only, as a function of the patient characteristics measured up to this specific exposure set.
Patients will be followed until the occurrence of an outcome of interest, diabetes, change in prediabetes therapy, death, transfer out of the dataset, or end of study period.
Comparison will be assessed using Cox proportional hazards regressions and Fine and Gray proportional subdistribution hazard regressions with competing events as the change in prediabetes therapy (discontinuation, switch, addition).
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Burden and consequences of the use of COPD-related systemic corticosteroids — David Price ...
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Burden and consequences of the use of COPD-related systemic corticosteroids
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-13
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Victoria Carter - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Abyramy Kadayam Srikanth - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Alberto Papi - Collaborator - University of Ferrara
Benjamin Emmanuel - Collaborator - Astra Zeneca Ltd - UK Headquarters
Derek Skinner - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Hilda de Jong - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marianna Alacqua - Collaborator - Astra Zeneca Inc - USA
Marjan Kerkhof - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Mona Bafadhel - Collaborator - University of Oxford
Shay Soremekun - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Xiao Xu - Collaborator - Astra Zeneca Inc - USAOutcomes:
The following outcomes will be measured:
Utilisation pattern of COPD-related or all-cause SCS use (SCS use and non-SCS use; SCS-arm only: cumulative dose (g); average daily dose (mg/day); long-term maintenance treatment; number of acute courses; Intermittent SCS use); incidence, recurrence or worsening of comorbidity outcomes: type 2 diabetes mellitus, hypertension, cardio-/cerebrovascular disease (myocardial infarction, dyslipidaemia, congestive heart failure, cerebrovascular accident), osteoporosis, osteoporotic fracture, weight gain, sleep disorders, sleep apnoea, peptic ulcer, cataracts, glaucoma, depression/anxiety, psychosis, pneumonia, antibiotic treated infections, sudden death, and renal impairment; HCRU and associated costs (general practitioner (GP) consultations, outpatient visits (i.e. specialist consultations), inpatient hospital admissions, Accident and Emergency (A&E) attendances, primary care medication prescriptions, or use of continuous Positive Airway Pressure (CPAP) device for sleep apnoea (if data are available in Hospital Episode Statistics (HES)) for SCS-related all-cause and specified comorbid conditions); number of moderate or severe exacerbations; number of patients not on maintenance treatment for COPD (preceding and post diagnosis of COPD); change in maintenance treatment; change blood eosinophil counts after SCS use.
Description: Technical Summary
This study will use a historical cohort study design to describe and quantify the utilisation patterns of SCS use, as well as the risk of SCS-associated comorbidities, healthcare resource utilisation and associated costs among COPD patients. The descriptive component of the study will examine records of SCS prescriptions (cumulative exposure, mean daily exposure) in general practice and the relationship to other baseline variables (maintenance treatment changes, blood eosinophil counts, exacerbations rates).
The hypothesis-testing component of this study will compare the onset or worsening of SCS-related morbidities (side effects) in those initiating SCS (SCS arm) with those not exposed to SCS (non-SCS arm) The two patient groups will be matched, according to relevant demographic and clinical characteristics. A one-year baseline period will be used to identify variables for matching, and patients will be followed up during the available outcome period. The incidence rate of each comorbid outcome in patients exposed to SCS and patients not exposed to SCS, as cases per 100 patient-years of follow-up (100 patient-year), will be compared using the incidence rate difference and the incidence rate ratio (IRR) with 95% confidence intervals (CIs). To account for all HCRU outcomes, the study will include only the subset of COPD patients with HES linkage in the final study population. HCRU and associated costs will be assessed annually, and annual averages for the entire follow?up period will be calculated. The aim of these analyses will be to identify potential SCS dose thresholds at which the onset, recurrence or worsening of comorbid conditions occurs in patients with COPD and HCRU increases.
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Exploring clinical pathways of knee joint replacement using large-scale electronic healthcare record data — George Peat ...
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Exploring clinical pathways of knee joint replacement using large-scale electronic healthcare record data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-30
Organisations:
George Peat - Chief Investigator - Keele University
Dahai Yu - Corresponding Applicant - Keele University
Aleksandra Turkiewicz - Collaborator - Lund University
Elizabeth Cottrell - Collaborator - Keele University
Geraint Thomas - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Martin Englund - Collaborator - Lund University
Thomas Appleyard - Collaborator - Keele UniversityOutcomes:
Total Knee Replacement
Description: Technical Summary
As a common cause of disability, knee osteoarthritis is managed by non-pharmacological, pharmacological and surgical treatment. Although joint arthroplasty, effective for end-stage knee osteoarthritis, is recommended, it is unclear whether care prior to arthroplasty has changed â i.e. further medical management, other joint procedures, or arthroplasty earlier. Further, variations in the care due to age, sex, and region remain undefined.
We will utilise descriptive analysis, case-control analysis, and sequence analysis of primary care and secondary care data (via linkage to Hospital Episode Statistics
) to explore the care timeline prior to arthroplasty. This will include healthcare consultations, pharmacological and surgical management, as well as referrals to other services.
In the descriptive analysis, a retrospective case-only study among patients who undergo arthroplasty, the absolute frequency of each care strategy will be explored by specific time-windows (i.e. 6, 12months) prior to arthroplasty and stratified by age, sex, region, comorbidities, and socio-economic status (via linkage to Index of Multiple Deprivation).The nested case-control analysis will be used to estimate the relative frequency of each care strategy outlined above by comparing the frequency of care among cases (patients with osteoarthritis who undergo arthroplasty) with that of risk-set sampled controls (age, sex, practice-matched patients with osteoarthritis who have not undergone arthroplasty) . Odds ratios obtained from conditional logistic regression will suggest when and which care strategies are most strongly associated with future arthroplasty. These building blocks will be classed into channels and then combined in the final stage of multi-channel sequence analysis to produce a small number of discrete care pathways and estimates of the numbers of patients following these and their respective characteristics. We aim to disseminate this work to patients, to provide information of projected care trajectories, as well as to health practitioners and commissioners, to aid in service provision for knee osteoarthritis.
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Characterisation of nasal polyp patients with and without surgery in England (CPRD-HES) — Victoria Benson ...
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Characterisation of nasal polyp patients with and without surgery in England (CPRD-HES)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-11
Organisations:
Victoria Benson - Chief Investigator - GSK
Jennifer Reed - Corresponding Applicant - GlaxoSmithKline - USA
Ana Sousa - Collaborator - GSK
Peter Howarth - Collaborator - GSK
Qinggong Fu - Collaborator - GSK
Robert Chan - Collaborator - GlaxoSmithKline - UK
Shibing Yang - Collaborator - GSKOutcomes:
Patient demographics; clinical characteristics; selected comorbidities; NP-related prescriptions; blood eosinophil levels; HRU; CRS surgeries; NP surgery failures; surgery complications
Description: Technical Summary
The intention of this study is to provide reliable data on the prevalence of nasal polyps (NP) identified in a primary care database as well as describe disease burden in England. Specifically, the primary objective is to characterise adult NP patients stratified by the number of surgeries for the removal of NP (i.e. 0, â¥1, â¥2 surgeries) with respect to their demographics, comorbidities, treatment patterns, and healthcare resource utilisation (HRU). Treatment patterns and HRU will also be assessed in the 30-days prior to surgery and 30- and 90-days post-surgery to understand the peri-surgery period. Secondary objectives include: 1) To estimate the point prevalence of diagnosed NP on 31st December, 2018 among adults in England and to determine the percentage of these patients with surgery; 2) To evaluate the rate and frequency of NP surgery, NP surgery failure and complications, and chronic rhinosinusitis (CRS) surgery among NP patients post-surgery, and to describe time between NP surgeries; and 3) To report blood eosinophil (EOS) levels among NP patients with and without NP surgery and by number of future surgeries. Patients will be stratified by the number of surgeries during follow-up and asthma status (sensitivity analysis).
Important comorbidities include CRS, asthma, NSAID-exacerbated respiratory disease (NERD), and chronic obstructive pulmonary disease (COPD). Treatments include nasal corticosteroids, systemic corticosteroids (including oral corticosteroids), and oral antibiotics. HRU includes all-cause attendances, all-cause GP attendances, all-cause inpatient attendances, and all-cause outpatient attendances.
This is a descriptive retrospective cohort study using the Clinical Practice Research Datalink (CPRD)-Aurum with Hospital Episodes Statistics (HES) linkage. HES APC data will be used to determine inpatient attendances, and HES OP data will be used to determine outpatient attendances. Statistical methods include count, percentage, mean, median, interquartile range, incidence rate, Kaplan-Meier curve, point prevalence, and proportion.
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Pharmacological risk factors for community-acquired pneumonia in asthma: population-based study in England — Chloe Bloom ...
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Pharmacological risk factors for community-acquired pneumonia in asthma: population-based study in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-05
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
Pneumonia and lower respiratory tract infections.
Description: Technical Summary
Population of people with asthma will be identified in the Gold and AURUM database. Patients with COPD, pregnancy, dementia or immunosuppression or previously used inhaled, nasal or oral corticosteroids will be excluded. The primary outcome with be pneumonia, identified either in CPRD, Hospital Episodes Statistics or on death certificate (Office of National Statistics). Secondary outcomes will be lower respiratory tract infection and hospitalised pneumonia only. Primary exposures will be inhaled corticosteroids and proton pump inhibitors. To describe the association between exposures and outcomes, different study designs will be used, survival model using Poisson regression with multivariable adjustment, assessment of drug-drug interaction and on-treatment analysis, case-control with different exposure times measured and self-case controlled series stratified by drug use, drug dosage and types of drugs. Covariates considered in the models will include age, gender, socioeconomic status (IMD), asthma severity (using asthma medication and exacerbations in year prior to study entry), oral corticosteroid use in past three years, BMI, vaccination (influenza and pneumococcal), bronchiectasis, obstructive sleep apnoea, atopy, cardiovascular disease, cerebrovascular disease, renal failure, rheumatic diseases, lung fibrosis, reflux, previous pneumonia, smoking, alcohol, and depression. Restricted cubic splines will be used to assess if there is a non-linear relationship between drug dose and outcomes.
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Outcome of fractures in people with intellectual disabilities — Valeria Frighi ...
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Outcome of fractures in people with intellectual disabilities
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-01
Organisations:
Valeria Frighi - Chief Investigator - University of Oxford
Valeria Frighi - Corresponding Applicant - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Tim Holt - Collaborator - NHS BATH AND NORTH EAST SOMERSET, SWINDON AND WILTSHIRE CCGOutcomes:
Primary outcomes
Impaired healing, impaired mobility within one year of any fracture
Mortality from any cause within one-year of any fracture, and of hip fractureSecondary outcomes
Psychological morbidity within six months of any fracture
Mortality within 30-days of hip fractureDescription: Technical Summary
In a previous CPRD study funded by the National Institute of Health Research we found that people with intellectual disabilities (ID) have higher fracture rates and younger age at fracture than the general population. The study included the largest cohort of ID people ever studied. The difference was particularly marked for hip fracture, for which incidence rates in adults aged ⥠50 years with ID compared to those without ID was almost four times as high in men and over twice as high in women. In current guidelines, ID patients are not identified as at high risk of osteoporosis and fractures, and in clinical practice there is widespread lack of awareness of the problem. In people with ID, fractures can be particularly serious, due to difficulties in accepting immobilisation, limited compliance with rehabilitation, and pre-existing physical disabilities. The consequences of hip fracture could be particularly severe. However, to our knowledge, this problem has never been studied in these patients.
In this study, we will compare the incidence of negative outcomes of fractures, namely impaired healing, impaired mobility, and psychological distress, in people with and without ID. We will also compare mortality after any fracture and after hip fracture. ID patients and fractures will be identified according to the same Read codes/medcodes used in our âparent studyâ. For each person with ID weâll select up to five people without ID, matched on year of index, age at index and gender. Outcomes will be compared between these groups and reported as relative risks with confidence intervals. Using Poisson regression with robust variances or equivalently log binomial regression we will investigate the influence of a range of pre-specified covariates and potential confounders.
Our overarching aim is to improve the evidence base supporting a fracture prevention programme for people with intellectual disabilities.
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Real world disease burden and treatment patterns among patients diagnosed with gastroparesis in England — Paul Berg ...
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Real world disease burden and treatment patterns among patients diagnosed with gastroparesis in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-07
Organisations:
Paul Berg - Chief Investigator - IQVIA Ltd
Zainab Mohamoud - Corresponding Applicant - IQVIA Ltd
Elizabeth Adamson - Collaborator - IQVIA Ltd
Peter McMahon - Collaborator - IQVIA LtdOutcomes:
Clinical and demographic characteristics (e.g. age, sex, year of diagnosis, comorbidities), pharmacological treatments for gastroparesis, surgical interventions for gastroparesis, line of therapy, treatment duration, all-cause HCRU costs: primary care visits, hospitalisations, medication prescriptions, procedures.
Description: Technical Summary
This is a retrospective cohort study using CPRD-HES linked data to describe the disease burden, characteristics and treatment patterns among gastroparesis patients in England. The study includes all prevalent patients with a diagnosis of gastroparesis (based on Read codes) in their CPRD record, who are eligible for linkage to Hospital Episode Statistics (HES) data and will be followed-up from the most recent of 1st January 2007 or date of first gastroparesis diagnosis until censoring, death or end of the study time period (most recently available data). Patients will be subdivided into diabetic gastroparesis (DG) and idiopathic gastroparesis (IG) dependent on the presence of a record of diabetes diagnosis or treatment in their CPRD record. Patients of other aetiologies will be excluded.
Clinical/demographic characteristics (e.g. age, sex, year of diagnosis/index), the proportion of patients who received medications and procedures to treat gastroparesis at any time during follow-up will be described. Treatment patterns among incident patients will be described using Sankey plots showing 1st, 2nd and 3rd lines of therapy, treatment duration and switches. All-cause HCRU and HCRU costs will be assessed and compared to a matched cohort of non-gastroparesis patients. HCRU will be described in terms of inpatient admissions, outpatient visits and A&E visits. Comparator cohorts will have the same inclusion/exclusion criteria as the study cohort, with the added requirement of no gastroparesis diagnosis. Comparators will be matched using either exact or propensity score matching depending on data availability and suitability. All analyses will be stratified by DG vs. IG.
Results will be described using mean (SD), median, minimum and maximum values for continuous variables and counts, percentages and 95% confidence intervals for categorical variables. Diagnoses, patient characteristics and medications will be captured using primary care data from CPRD, whilst medical procedures and HCRU analysis will use linked HES data.
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MuSculoskeletal paiN durIng the COVID-19 PandEmic: an observational study of UK national primary care electronic health records (the SNIPE Study) — Victoria Welsh ...
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MuSculoskeletal paiN durIng the COVID-19 PandEmic: an observational study of UK national primary care electronic health records (the SNIPE Study)
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-19
Organisations:
Victoria Welsh - Chief Investigator - Keele University
Victoria Welsh - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Claire Burton - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Kayleigh Mason - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Martin Frisher - Collaborator - Keele University
Ram Bajpai - Collaborator - Keele UniversityOutcomes:
Prevalence and incidence of primary care consultations for RMD-related conditions per 10,000 persons in the registered population.
Prevalence and incidence of analgesic prescribing (paracetamol, NSAIDs (non-steroidal anti-inflammatory drugs), opioids, amitriptyline, gabapentinoid and duloxetine) per 10,000 registered population and per 10,000 population with an associated RMD-related consultation.
Period prevalence of referrals, and incidence of RA and JIA.
Time in days between incident RMD consultation and i) referral and ii) incident RA / JIA diagnosis.
All of these outcomes will be measured before, during, and after the pandemic period.
Description: Technical Summary
The SNIPE study builds on observations from practising clinicians and patients that the COVID-19 pandemic has substantially affected the care delivered to patients with musculoskeletal disorders in primary care. Patients are being managed remotely with no access to routine specialist services. Instead, they may be prescribed analgesia at increasing strength and thus are at risk of harm. There are also concerns that, as with cancer, reluctance to consult, remote consulting and a hold on routine referral pathways may lead to delayed diagnosis of inflammatory arthropathies (IA) (for example, rheumatoid arthritis and Juvenile Idiopathic Arthritis).
The SNIPE study objective is to investigate the impact of the pandemic on the care of adults and children with musculoskeletal disorders. Three hypotheses will be addressed:
1) that the COVID-19 pandemic has affected the numbers of patients consulting in primary care with musculoskeletal conditions from any cause;
2) that analgesic prescribing for these patients has changed;
3) that the time to diagnosis of IA has been affected by the pandemic.The study population includes all primary care users whose electronic records are included in CPRD Aurum. Prevalence and incidence of consultations for all musculoskeletal conditions and associated analgesic prescribing, and time to diagnosis of IA, will be measured throughout the pandemic periods and differences presented; To overcome difficulties defining fluid time periods, Joinpoint regression will be used to identify significant changes in trends. The study will be conducted in two workstreams to enable timely delivery of results to guide swift action in preparation for future pandemic phases. Workstream 1 will investigate the pre-pandemic peroid and the current COVID-19 wave; Workstream 2 will investigate the time period following the current COVID-19 phase. Workstream findings will be developed with stakeholders including public involvement (PI) and disseminated through PI activities, digital platforms and traditional methods.
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An observational cohort study of intermittent oral corticosteroid use and its association with adverse outcomes and healthcare resource use and costs in asthma using the Optimum Patient Care Research and Clinical Practice Research Datalink databases. — Ekaterina Maslova ...
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An observational cohort study of intermittent oral corticosteroid use and its association with adverse outcomes and healthcare resource use and costs in asthma using the Optimum Patient Care Research and Clinical Practice Research Datalink databases.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-11
Organisations:
Ekaterina Maslova - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Heath Heatley - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
David Price - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Derek Skinner - Collaborator - Optimum Patient Care Ltd
Marjan Kerkhof - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Trung Tran - Collaborator - Astra Zeneca Inc - USAOutcomes:
Outcomes for Objective 1: Baseline patient characteristics will be collected according to patients OCS patterns of use
⢠patient characteristics (age, gender, BMI, asthma control RCP3, blood eosinophil count, lung function) described prior to index date
⢠length of patient record prior and after index date
⢠age of onset of asthma (age at first asthma diagnosis ever)
⢠time from first asthma diagnosis date to index date
⢠ICS and SABA use prior to index date
⢠patientâs treatment by GINA (2019) treatment step prior to index dateOutcomes for Objectives 2 & 4: Adverse events associated with intermittent OCS use
An adverse event for the following conditions:
Diabetes - A diagnosis, prescription or test result indicating diabetes
Osteoporosis diagnosis
Hypertension diagnosis
Glaucoma diagnosis or treatment
Sleep apnoea diagnosis, referral to sleep clinic or continual use of a CPAP device
Weight gain - Increase in Body Mass Index (BMI) by at least 1 kg/m2 compared to index date
Depression/anxiety â diagnostic code, or diagnostic code AND treatment
Pneumonia â diagnostic code
Cataract â diagnostic code and/or cataract surgery
Sleep disorders â diagnostic code and/or hypnotic medications
Renal impairment - Chronic kidney diagnosis (CKD stages 3a, 3b, 4,5)
Dsyipidaemia onset - Diagnostic code for dyslipidaemia OR hyperlipidaemia OR hypercholesterolaemia OR hypertriglyceridaemia
Peptic ulcer disease - diagnostic code
Adolescent population â Behavioural disorders â Diagnostic codes
Adolescent population - Growth suppression â Diagnostic codesOutcomes for Objective 3: Annualised healthcare resource utilisation and related costs
HRU categories for all events and asthma specific events for
Physician visits
Outpatient visits
Accident & Emergency
Hospital attendances spells (including and excluding day cases)
Hospital attendances length of stay (overall and >0 night)
Day cases spellsDescription: Technical Summary
Overall Aim: This study aims to investigate the relationship between patterns of intermittent OCS use and adverse events and healthcare resource utilisation (HRU).
Design: This is an historical cohort study combining data from CPRD and Optimum Patient Care UK. The cohort will be patients prescribed with intermittent OCS prescription with a concurrent asthma event, at least 12 months of baseline data, and aged 4 or over at the time of their first OCS prescription.
Exposure and outcomes: The primary exposure will be an acute prescription of OCS with a concurrent asthma event (either prescription or diagnosis). Outcomes will include adverse events (AE) including type 2 diabetes mellitus, osteoporosis/osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain and depression/anxiety, pneumonia, cataracts, sleep disorders, cardiovascular disease, chronic kidney disease, dyslipidaemia and peptic ulcer disease, and in the adolescent population we will look for growth suppression and behavioural disorders.
Analysis: OCS prescriptions will be classed as either intermittent or maintenance based upon their dosing instructions, prescription strength and duration. Patterns of OCS prescription will be categorised according to their prescribing frequency (one off, sporadic, frequent etc). Baseline characteristics will be described for patients according to their patterns of intermittent OCS use by GINA step of treatment, and ICS and SABA use.
A matched historical cohort study will be performed according to their patterns of OCS prescribing. To address potential differences between OCS groups, patients will be matched initially on gender, age, and the index date
HRU events, up for both asthma-related and all-cause events, will be described over the follow up period using the CPRD dataset. CPRD HES linked data will be used to describe hospital admissions, A&E attendances, and Outpatient visits
An analysis of AE will be undertaken according to average annual OCS dose of 250-499mg, 500-999mg, or =>1g during the follow up
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Development of a prediction model in Pompe disease, Fabry disease, and Gaucher disease based on UK electronic primary healthcare records and linked secondary care data. — Craig Currie ...
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Development of a prediction model in Pompe disease, Fabry disease, and Gaucher disease based on UK electronic primary healthcare records and linked secondary care data.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-19
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sue Beecroft - Corresponding Applicant - Harvey Walsh Ltd
Ben Van Hout - Collaborator - Harvey Walsh Ltd
Clare Halcro - Collaborator - Genzyme - Sanofi Company
Eleanor Saunders - Collaborator - Genzyme - Sanofi Company
Kinga Malottki - Collaborator - Genzyme - Sanofi Company
Matthew O'Connell - Collaborator - Harvey Walsh Ltd
Rachel Lawson - Collaborator - Genzyme - Sanofi Company
Viktor Chirikov - Collaborator - OPEN Health GroupOutcomes:
Pompe disease; Fabry disease; Gaucher disease (Type I and III); survival; co-morbidities (respiratory, ocular, auditory, cardiovascular, musculoskeletal, renal, sleep disturbance, neurological and gastrointestinal); wheelchair use, ventilator use; secondary care and primary care resource use.
Description: Technical Summary
This study aims to find predictors to detect those at highest risk of a diagnosis of late onset Pompe disease (LOPD), Fabry disease, and Gaucher disease (Type I and III).
The disease predictor machine learning modelling will identify predictors of a diagnosis of a Liposomal Storage Disease (LSD). Cases of each disease will be matched to non-cases by age and sex with a target ratio of 1 case to 20,000 controls. These training cases and controls will be used to build a predictive model for those at risk of the disease. Patient characteristics indicative of the disease will be pre-specified based on published literature and key opinion leader (KOL) input. The training dataset will build and train various implementations of the predictive algorithm using i) logistic regression and ii) machine learning using random forest methodology including pre-specified clinical variables.
By simultaneously processing a large number of predictors, using random forest provides a measure of each variableÂs importance in the context of multivariate interactions with other predictors that might have gone unnoticed in traditional analysis subgroup models, where the selection of variables and their interactions are driven by pre-specified rules regarding statistical significance. Random forest methodology employs a Âsystematic approach to the development of subgroups, which are constructed sequentially through repeated, binary splits of the population of interest, one explanatory variable at a time. In other words, each Âparent group is divided into two Âchild groups, with the objective of creating increasingly homogeneous subgroups. Random forest variable importance may reveal higher importance scores for variables working in complex interactions, which may have gone unnoticed in parametric regression models.
The resultant algorithm will then be tested and validated on re-finding the diagnosed population.
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Descriptive efficiency and safety of a combination of ramipril and bisoprolol in patients with primary hypertension: A Database Study — Emmanuelle Jacquot ...
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Descriptive efficiency and safety of a combination of ramipril and bisoprolol in patients with primary hypertension: A Database Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-07
Organisations:
Emmanuelle Jacquot - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Kirsty Andresen - Corresponding Applicant - OXON Epidemiology - UK
Bélène Podmore - Collaborator - OXON Epidemiology - Spain
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Lorena Baquero Portela - Collaborator - OXON Epidemiology - Spain
MIGUEL DESCALZO - Collaborator - OXON Epidemiology - Spain
Nawab Qizilbash - Collaborator - OXON Epidemiology - Spain
Raúl Sánchez - Collaborator - OXON Epidemiology - Spain
Rosie Barnett - Collaborator - OXON Epidemiology - SpainOutcomes:
Effectiveness: Blood pressure change and blood pressure control;
Safety (Adverse Events): Hepatic impairment; Obstructive pulmonary disorders; Anaphylactic shock; Hypotension; Renal impairment/renal dysfunction; Bradycardia; Arrhythmia; Peripheral artery disease; Severe skin reaction; Bone marrow depression; Pancreatitis; Death.Description: Technical Summary
The aim of this cohort study is to describe the effectiveness of the free combination of ramipril and bisoprolol on change of blood pressure (BP) in individuals with uncontrolled primary hypertension who start at dosage â¥5mg on both treatments Ramipril and Bisoprolol. The treatment with the free combination of ramipril and bisoprolol will be categorised as either a concomitant prescription or a sequential add-on prescription according to how the treatment was modified at index date.
Concomitant initiation is defined when an individual is first prescribed with dosages â¥5mg for both drugs, ramipril and bisoprolol (or in a time window < 15 days). Sequential add-on prescription is defined when a dosage â¥5mg for the second monocomponent is added more than 15 days after of an existing stable treatment at a dosage â¥5mg of the first component. Individuals will be excluded if they have a record of the second monocomponent at a dosage â¥5mg in the 6-months prior to its initiation.
Individuals will be followed-up for a maximum of 12-months, or until the dosage of any of the monocomponents is decreased to <5 mg, one of the drugs or both are stopped, a change in another hypertensive medication, loss to follow up or death.
Changes in systolic and diastolic BP and the proportion of individuals who achieve BP control will be assessed at 3 months and 6 months compared to the baseline BP measurement at ID. The patient profile of demographic characteristics, existing comorbidities, prior cardiovascular disease history and concomitant medications use will also be described. The incidence of safety events of interest reported during treatment period + 30 days with a maximum follow-up of 12 months after ID will be reported.
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Which patient groups at risk for type 2 diabetes benefit from lifestyle interventions: a regression discontinuity design — Till Bärnighausen ...
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Which patient groups at risk for type 2 diabetes benefit from lifestyle interventions: a regression discontinuity design
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-05
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of HeidelbergOutcomes:
Primary outcomes (all to be measured over time horizons of six months, one year, three years, and five years):
Type 2 diabetes diagnosis (binary); time to type 2 diabetes diagnosis; number of all-cause emergency hospitalizations; number of diabetes-related and cardiovascular disease-related emergency hospitalizations; number of severe adverse health events (diabetic coma, stroke, heart attack [myocardial infarction] â each event type evaluated separately); all-cause mortality; change in HbA1c level; change in fasting plasma glucose level; dyslipidaemia (levels of cholesterol and triglycerides); levels of overweight (with BMI cut-offs of BMI>=25, BMI>=30) and change in BMI, hypertension (with blood pressure cut-offs of >=140/90 mm Hg, >=160/100 mm Hg)Secondary outcomes (all to be measured over time horizons of six months, one year, three years, and five years):
Probability of at least one all-cause emergency hospitalization; probability of at least one diabetes-related and cardiovascular disease-related emergency hospitalization; number of all-cause hospitalizations; probability of at least one all-cause hospitalization; number of diabetes-related and cardiovascular disease-related hospitalizations; probability of at least one all-cause hospitalization; probability of at least one diabetes-related and cardiovascular disease-related hospitalizations; probability of at least one severe adverse health event; diabetic complications (opthalmic, neurological and renal complications of diabetes); presence or absence of osteoarthritis, osteoporosis, injuries induced by falls, and erectile dysfunctionBehavioral variables, i.e. change in smoking status, presence or absence of smoking, and documentation/presence or absence of hazardous alcohol consumption, will be explored as potential intermediate outcomes.
Description: Technical Summary
Previous studies investigating the health effects of lifestyle intervention administered to people at risk of diabetes type 2 are largely limited to controlled clinical trials. While these studies have pointed towards the efficacy of lifestyle intervention in improving key health outcomes, they might not be able to fully capture treatment effectiveness during routine care and frequently lack the necessary time horizon to study long-run benefits and risks. Non-experimental studies, in contrast, may fail to establish causality due to insufficient control of confounding factors. This study seeks to measure the effect of lifestyle intervention on short-, mid-, and long-term clinical outcomes (progression to type 2 diabetes, mortality, emergency hospitalizations, major adverse health events) in a routine care set-up for adult men and adult women. To establish causality, we make use of a regression discontinuity (RD) design taking advantage of public health guidelines recommending intensive lifestyle intervention based on threshold rules related to patientsâ HbA1c and fasting plasma glucose levels. Because physicians base their treatment decisions on additional considerations besides public health guidelines, and lifestyle intervention programs may not always be available, we use an instrumental variable approach that is robust to partial compliance. We evaluate the robustness of results by gradually narrowing down the bandwidth around the treatment threshold and thus only including patients with HbA1c or fasting plasma glucose levels increasingly close to the treatment threshold level. In addition, we will test for heterogenous treatment effects by stratifying our sample by sex, age, ethnicity, socioeconomic status, urban vs rural place of residence, and comorbidities. Sensitivity analyses will focus on potential time effects (i.e. introduction of revised guidelines) and different operationalizations of lifestyle interventions. The findings of this study are expected to provide novel insights into the effectiveness of lifestyle intervention in a real-life setting and can directly inform clinical practice.
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European non-interventional post-authorization safety study related adherence to the risk minimization measures for romosozumab by the EU-ADR Alliance — Alireza Moayyeri ...
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European non-interventional post-authorization safety study related adherence to the risk minimization measures for romosozumab by the EU-ADR Alliance
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-26
Organisations:
Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Annika Jodicke - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Chao Lu - Collaborator - UCB BioSciences, Inc.
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Maria Sanchez - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Population level measures: monthly prevalence of use; monthly incidence of use
Patient level measures: duration of treatment/persistence; proportion persistent at 6, 12, 18 and 24 months; proportion switching treatment at 6, 12, 18 and 24 months; prevalence of contraindications amongst new romosozumab users; prevalence of documented indication amongst new romosozumab users.
Specific drug utilization measures for romosozumab users: compliance; discontinuation before 12 months.
Description: Technical Summary
Objective
The aim of this study is to evaluate adherence to the cardiovascular risk minimization measures (RMMs) for the use of romosozumab in the United Kingdom. To achieve this, utilization patterns, adherence to contraindications and target indications will be described amongst incident romosozumab users in routine clinical practice.
Specifically, the study objectives are:
1. Assess the prevalence and incidence of romosozumab use at the population level and the relative trends over time;
2. Characterize users of romosozumab, and to evaluate compliance with the EU approved indication and contraindication (history of MI or stroke) as per the RMMs
3. Describe prevalence and incidence of use of other OP medications, to characterize users and to provide context.
Population
The population is made of all adults in the UK registered in CPRD who are aged 18+ and have a specified gender.
Exposure
The exposure of interest is romosozumab. Comparator exposures are alendronate; other oral bisphosphonates; intravenous bisphosphonates; selective estrogen receptor modulators (SERMs); denosumab; and teriparatide.
Outcome
Outcomes come under 3 headings: population level measures including monthly prevalence and incidence of use, patient level measures including persistence and prevalence of contraindications amongst new users, and specific drug utilization measures for romosozumab users including compliance with RMMs and discontinuation.
Methods
Population-level measures: Monthly prevalence/incidence (and 95% Cis) of use overall per drug and after stratification will be estimated assuming a Poisson distribution. Secular trends/graphs will be plotted.
Patient-level: continuous outcomes will be reported as median (inter quartile range) and categorial outcomes will be reported as numbers and percentages (n[%]). Kaplan-Meier plots will depict persistence, whilst Sankey graphs will be plotted to illustrate treatment patterns/switching over time.
Characteristics of the different cohorts will be described for all potential covariates using quantitative measures (mean [SD], median [inter-quartile range]) or n(%) for each of the individual features.
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Comparative adherence and persistence of single & multiple inhaler triple therapies among patients with Chronic Obstructive Pulmonary Disease in the United Kingdom in a real-world primary care setting — Kieran Rothnie ...
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Comparative adherence and persistence of single & multiple inhaler triple therapies among patients with Chronic Obstructive Pulmonary Disease in the United Kingdom in a real-world primary care setting
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-28
Organisations:
Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Joseph Thomas - Collaborator - Adelphi Real World
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Stuart Blackburn - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Adherence to multiple inhaler triple therapy (MITT) and single inhaler triple therapy (SITT) as a categorical variable; Persistence to MITT and SITT; Adherence to MITT and SITT as a continuous variable.
Description: Technical Summary
Aim: The overall study aim is to evaluate medication adherence and persistence for patients with chronic obstructive pulmonary disease (COPD) who have newly initiated either multiple inhaler triple therapy (MITT) or single inhaler triple therapy (SITT).
Objectives: The primary objective is to compare medication adherence in COPD patients using MITT versus SITT. Comparisons will be made between patients i) initiating MITT vs SITT; ii) initiating MITT vs each of the two SITTs currently available in the UK a) fluticasone furoate (FF), umeclidinium (UMEC) and vilanterol (VI) and b) beclomethasone (BDP), formoterol (FF) and glycopyrronium bromide (GB); Persistence will be evaluated for each comparison as a secondary objective. A FF/UMEC/VI vs BDP/FF/GB comparison for adherence and persistence will also be conducted as secondary objectives.
Primary exposures: MITT and/or SITT use.
Primary outcomes: Medication adherence to MITT and SITT therapies at 6, 12 and 18 months post-triple therapy initiation.
Methods: A new-user, active comparator, retrospective cohort study using inverse probability of treatment weighting (IPTW) of COPD patients initiating triple therapy between November 2017 and June 2019 in CPRD Aurum. Linked Hospital Episode Statistics-Admitted Patient Care data will also be used. The minimum required follow-up period will be 6 months to assess adherence.
Data analysis: Adherence will be classified using proportion of days covered (PDC); PDC<80% representing non-adherence, PDCâ¥80% adherent. A propensity score (PS) based methodology will be implemented for all treatment comparisons to minimise potential confounding and evaluate the average treatment effect in the entire population. It is proposed that PSsâ will be generated via logistic regression modelling and applied using IPTW. Persistence will be assessed using Kaplan Meier survival analysis and Cox proportional hazards models to assess time-to-non-persistence.
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Chronic kidney disease burden and characterisation of patients by renal function testing, treatments and comorbidities - an observational study — Jil Billy Mamza ...
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Chronic kidney disease burden and characterisation of patients by renal function testing, treatments and comorbidities - an observational study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-22
Organisations:
Jil Billy Mamza - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Jil Billy Mamza - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Alexander Gueret-Wardle - Collaborator - Astra Zeneca Ltd - UK Headquarters
Emily Peach - Collaborator - Astra Zeneca Ltd - UK Headquarters
Matthew Arnold - Collaborator - Astra Zeneca Ltd - UK Headquarters
Patrick Mark - Collaborator - University of Glasgow
Ruiqi Zhang - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
The study outcomes are aligned to the core objectives of this study and described below.
Primary outcomes include composite and individual components of specific hospitalisations for heart failure (HF), myocardial infarction (MI), stroke, peripheral artery disease (PAD), renal outcomes (including renal function decline, hospitalisation for kidney diseases, end-stage renal disease [ESRD] and dialysis), cardiovascular and all-cause death, and their associated risk factors.
Secondary outcomes include monetised costs of health care resource use; resources include disease management services in the clinical guideline, e.g., GP consultations, laboratory tests, medications and hospitalisations. Others include urgent care visits, emergency department attendances, and dialysis.
Description: Technical Summary
Using a cohort of patients with kidney diseases, we will describe and compare the characteristics of chronic kidney disease (CKD) patients, patterns of disease progression and adverse complications over time, including the epidemiology of kidney disease in various subgroup populations.
This study will utilise routinely collected primary care and secondary care records of patients to investigate clinical outcomes. The main outcomes of interest include all-cause death (including cardiovascular or renal deaths), reduction in estimated glomerular filtration rate (eGFR) or urine:albumin creatinine ratio (UACR), specific hospitalisations for heart failure, myocardial infarction, stroke, peripheral artery disease, hyperkalaemia, and renal outcomes (acute and chronic kidney diseases, end-stage renal disease and dialysis).
The study will assess multiple subgroups of patients in both the descriptive analysis as well as the follow-up study design. Subgroups of interest include patients with or without type 2 diabetes mellitus, patients at different diagnostic clinical assessments of renal function (e.g., eGFR stages, uACR bands), patients with and without standard treatments for kidney disease, cardiovascular disease and diabetes mellitus. The study will also investigate outcomes in a subgroup of patients defined by clinical trial criteria described in the study population section.
The study period will begin on 1 January 2007 until the last GPâs collection date. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Survival distributions utilising Kaplan-Meir method will describe the time to clinical outcomes. Relative risks and risk factors associated with outcomes will be estimated using Cox proportional hazard models.
In addition, we aim to further evaluate the care pathways of the patients to describe health resource use including GP consultations, laboratory tests or measurements, medication, referrals to specialist and hospital admissions. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
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Atrial Fibrillation, cognitive impairment, dementia, and the impact of antithrombotic therapy: A population-based cohort study using the Clinical Practice Research Datalink. — Deirdre Lane ...
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Atrial Fibrillation, cognitive impairment, dementia, and the impact of antithrombotic therapy: A population-based cohort study using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-05
Organisations:
Deirdre Lane - Chief Investigator - University of Liverpool
Jose Ignacio Cuitun Coronado - Corresponding Applicant - University of Liverpool
Deirdre Lane - Collaborator - University of Liverpool
Gregory Lip - Collaborator - University of Liverpool
Iain Buchan - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of Liverpool
Stephanie Harrison - Collaborator - University of LiverpoolOutcomes:
1. Cognitive impairment. It will be defined by Read medical codes, with no recording of identified Alzheimerâs disease on or before the date recording the mild cognitive impairment.
2. Dementia. It will be defined using Read medical codes, with no recording of an identified non-Alzheimerâs disease or non-vascular cause of dementia on or before the date when dementia was recorded.Description: Technical Summary
Technical summary
In the United Kingdom (UK), there are approximately 11.9 million people aged 65 and over. With a prevalence of 1.985%, about 1.2 million (10%) of them have atrial fibrillation. In addition, there are between 0.6 and 2.4 million people with cognitive impairment and around 850,000 with dementia people in the UK.
Research suggests that there may be a link between atrial fibrillation and increased risk of cognitive impairment and/or dementia. There is some evidence that antithrombotic therapy (aspirin, warfarin, non-vitamin K antagonist oral anticoagulants (NOACs)etc.) used to prevent stroke in people with atrial fibrillation may help to avert and/or reduce the development of, and progression of, cognitive impairment. However, there are very few studies that have examined the link between atrial fibrillation and cognitive decline and the impact of anticoagulation on this relationship, and most have looked at small samples or samples that might not be representative.
Our study will use the Clinical Practice Research Datalink (CPRD), which is a representative sample of the primary care population in England. We will extract information on a sample of adults aged over 65 years. We plan to use this database to investigate the following research questions: (1) Is there a higher risk of cognitive impairment and/or dementia for people with atrial fibrillation? and (2) Does the use of antithrombotic therapy reduce the risk of cognitive impairment and/or dementia for people with atrial fibrillation?
Hazard ratios of the association between atrial fibrillation, cognitive impairment and/or dementia, overall and stratified by antithrombotic therapy (anticoagulants and antiplatelets), stroke risk determined with the CHA2DS2-VASc score, Charlson Comorbidity Index, and Frailty Index will be estimated using Cox regression. Sensitivity analyses will be performed excluding patients who are taking antidepressants as depression may represent a prodrome of dementia and with a history of stroke.
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Prevalence and socio-economic distribution of patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent patients with hypercholesterolemia, and familial hypercholesterolemia — Pascal Lecomte ...
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Prevalence and socio-economic distribution of patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent patients with hypercholesterolemia, and familial hypercholesterolemia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-06
Organisations:
Pascal Lecomte - Chief Investigator - Novartis Pharma AG
Hayden Holmes - Corresponding Applicant - York Health Economics Consortium Ltd ( YHEC )
Adeline Durand - Collaborator - Novartis UK
Ana Filipa Fonseca - Collaborator - Novartis Pharma AG
Erin Barker - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Hannah Wood - Collaborator - York Health Economics Consortium Ltd ( YHEC )
James Love-Koh - Collaborator - University of York
Joe Moss - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Raquel Lahoz - Collaborator - NOVARTISOutcomes:
Disease prevalence, Index of Multiple Deprivation (IMD) score quintile, patient demographics, and clinical and treatment characteristics
Description: Technical Summary
Low density lipoprotein cholesterol (LDL-C) has been strongly associated with cardiovascular disease and coronary heart disease risk. Reducing LDL-C with pharmaceutical interventions such as statins has been shown in clinical trials to be associated with reduced incidence of atherosclerotic cardiovascular disease (ASCVD). However, a large proportion of patients with elevated LDL-C have shown to be refractory to conventional cholesterol lowering regimens. Patients with familial hypercholesterolemia (FH) are particularly difficult to manage due to genetically high baseline LDL-C levels. Inclisiran is a subcutaneously delivered therapy that has shown in clinical trials to reduce refractory LDL-C in patients with ASCVD and FH. Given that strong associations have also been observed between cardiovascular events and socioeconomic status, Novartis is interested in understanding the potential impact of inclisiran on socioeconomic health inequalities in England. In this study we wish to conduct a non-interventional, descriptive study with no statistical comparison. We wish to use the Clinical Practice Research Datalink (CPRD) linked to the Hospital Episode Statistics (HES) admitted patient care dataset to obtain patients who would be eligible to receive inclisiran. Patients found in the CRPD and HES dataset will be linked to the Patient Level Index of Multiple Deprivation (IMD) to obtain their deprivation quintile group. We aim to identify three, non-mutually exclusive cohorts of patients with elevated LDL-C: i) history of ASCVD (coronary heart disease, cerebrovascular disease or peripheral arterial disease), ii) ASCVD-risk equivalent (defined as a diagnosis of type II diabetes mellitus or familial hypercholesterolemia without a cardiovascular event) and iii) familial hypercholesterolemia. We will describe these cohorts in terms of demographics and baseline therapy profile. The results for each cohort will be reported separately. These results will be used to analyse the potential impact of inclisiran on socioeconomic health inequalities in England.
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The prescribing trends and health risks of prescribed analgesic medication in the UK: an observational study based on the UK Clinical Practice Research Datalink — Daniel Mackay ...
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The prescribing trends and health risks of prescribed analgesic medication in the UK: an observational study based on the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-13
Organisations:
Daniel Mackay - Chief Investigator - University of Glasgow
Robert Pearsall - Corresponding Applicant - LANARKSHIRE
Barbara Nicholl - Collaborator - University of Glasgow
David Blane - Collaborator - University of Glasgow
Frederick Ho - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of GlasgowOutcomes:
1. The incidence and prevalence of analgesic medicine use: non-opioids (paracetamol, non-steroidal anti-inflammatory medication), opioid medication (e.g. codeine-based products, morphine, oxycodone, tramadol), cannabis based medicines, and the gabapentinoids.
2. The levels and trends of prescribing and long-term use of these medicines.
3. Adverse outcomes on both physical health (e.g. mortality, cardiovascular disease, cerebrovascular disease, respiratory disease) and mental health disorders (anxiety disorders, depression, psychotic disorders, attempted suicide/ deliberate self-harm).
4. Comorbid substance misuse.
5. Primary care contact time.Description: Technical Summary
The use of analgesic medication has increased in recent years including both non-opioid (e.g. paracetamol, non-steroidal anti-inflammatory medication), opioid medication (e.g. codeine based products, morphine, oxycodone, tramadol), cannabis based medicines, and the gabapentinoids (gabapentin, pregabalin). The prescription of analgesic medication is increasing in a range of areas of health care especially musculoskeletal disorders such as osteoarthritis, and non-cancer chronic pain. There is a gap in our understanding of these medicines as to firstly, the current extent of prescribing of strong analgesic medication and use, and secondly the impact of these medications on a range of adverse health outcomes. We will use CPRD Gold and Aurum data to determine which patients have received prescribed analgesic medication between the study dates of 1 January 1997 and 31st March 2020.
We will compare these individuals against a comparative control group comprising individuals that are not prescribed analgesic medication matched on a ratio 1:3 on the basis of gender, age, and social deprivation. We will use descriptive statistics to report, the monthly incidence and prevalence of analgesic medication use stratified by age and sex, the monthly daily dispensed dosage per 1000 patients and the annual supply days. For the purpose of incidence / prevalence calculation we will base our calculation on the use of denominator files within CPRD. We will measure the mean daily dose of each analgesic medication user and determine the annual incidence standardised to the age and sex distribution of adverse events. We will compare these results against the total monthly practice?level dispensing data of individuals over 18 years of age. The calculation of incident monthly prescriptions for analgesic use will exclude existing prevalent monthly medication. Proportional hazard modelling will be used to compare the risk of adverse events. Cox regression will be used to produce unadjusted and adjusted hazard ratios.
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Characteristics and treatment pathways among patients with chronic obstructive pulmonary disease receiving single device dual inhaler therapy in the UK in a real-world setting — Gema Requena ...
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Characteristics and treatment pathways among patients with chronic obstructive pulmonary disease receiving single device dual inhaler therapy in the UK in a real-world setting
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-28
Organisations:
Gema Requena - Chief Investigator - GlaxoSmithKline - UK
Victoria Banks - Corresponding Applicant - Adelphi Real World
Afisi Ismaila - Collaborator - GSK
Alexandrosz Czira - Collaborator - GSK
Eunmi Ha - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Stuart Blackburn - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Rate of moderate-to-severe exacerbations; Time-to-first on-treatment moderate-to-severe exacerbation; Time-to-triple therapy use (in multiple and single devices); Adherence to single device dual inhaler therapy (via PDC); Persistence to single device dual inhaler therapy (time from treatment initiation to discontinuation); Treatment pathways prior to and following single device dual inhaler therapy initiation; All-cause and COPD-related healthcare resource utilisation; All-cause and COPD-related direct medical costs
Description: Technical Summary
Aim: To describe the demographic and clinical characteristics of patients with COPD receiving single-inhaler dual therapy and to assess key clinical outcomes following initiation of these therapies.
Objectives: i) to describe sociodemographic and clinical characteristics of all single-inhaler dual therapy users ii) to describe the duration and sequence of treatments prior to and post initiating single-inhaler dual therapy iii) to describe healthcare resource utilisation (HCRU) and costs pre and post single-inhaler dual therapy initiation iv) to describe clinical outcomes (exacerbations, uptake of triple inhaler therapy, medication adherence and persistence) following initiation of single inhaler dual therapies.
Primary exposures: Single-inhaler dual therapy.
Outcomes: Sociodemographic and clinical characteristics; Treatment pathways; Direct medical costs; HCRU; Rate of moderate-to-severe exacerbations (AECOPD); Time-to-first AECOPD; Time-to-triple therapy; Medication adherence and persistence.
Methods: A retrospective cohort study of COPD patients receiving single-inhaler dual therapy between June 2015 and December 2018 (indexing period), using linked primary and secondary care administrative data. The index date will be defined as the date of the first prescription of single-inhaler dual therapy during the indexing period. A minimum of 12 months data prior to the index date will be required for inclusion into the study, during which baseline sociodemographic characteristics, clinical characteristics, treatment use/ patterns and HCRU/ costs will be described. Outcomes will be assessed at discrete time intervals (3, 6, 9, 12 months) post dual therapy initiation.
Data analysis: Counts, means, medians, standard deviation, 25th and 75th percentile values will be reported for numeric variables and relative frequencies, proportions/ percentages for nominal variables. HCRU and costs will be derived by observing consultations and medications in primary care, and Healthcare Resource Group for secondary care. Adherence will be classified using proportion of days covered (PDC) [PDC<80% representing non-adherence]. Persistence, time-to-first exacerbation, and time-to-triple therapy will be assessed using Kaplan Meier survival analysis.
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An investigation of the reliability and granularity of the recording of interstitial lung diseases in primary and secondary care datasets — Jennifer Quint ...
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An investigation of the reliability and granularity of the recording of interstitial lung diseases in primary and secondary care datasets
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-10-20
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Peter George - Collaborator - Royal Brompton Hospital
Rikisha Shah Gupta - Collaborator - Imperial College LondonOutcomes:
Number (and frequency) of ILD code occurrences (Read codes in CPRD GOLD and AURUM, and ICD-10 codes in HES/ONS);
- Crude estimates for prevalence and incidence of all ILD, and specific ILD subtypes (based on case identification in CPRD, using clinical diagnostic codes only);
- alternative strategies or algorithms for identifying cases of ILD by subtype in CPRD data, should reliance on simple lists of diagnostic clinical codes prove to be suboptimal.Description: Technical Summary
The validity of research based on CPRD data relies on the quality of the information recorded by GPs. Validation studies have suggested that the validity of clinical diagnoses of specific conditions is generally quite good, as evidenced by strong measures of positive predictive value (PPV), sensitivity and specificity. This is especially true of chronic diseases that are managed in a primary care setting, but less so for acute conditions that require hospitalisation.
Previous work has established the reliability of a diagnosis of IPF in GP records (PPV=95%). Given that IPF and other ILDs are almost always diagnosed in secondary care, this finding is not unexpected and it is generally accepted that a patient with an ILD diagnosis in their primary care record will indeed have the disease. However, questions remain about the completeness of the capture of cases of ILD in primary care data, the granularity of the recording in terms of ILD subtype, and whether GP recording practices have altered over time.
This validation study is designed to complement efforts to better characterise the incidence, prevalence and mortality associated with a number of important ILD subtypes, data for which are lacking at the present time but which are needed in order to support further research into this group of lung diseases. In the first instance, we will conduct a descriptive analysis in order to inform our understanding of how ILD is coded in primary and secondary care. We will then carry out investigations to see how well we can identify cases of specific ILDs using simple diagnostic code lists, and/or whether we need to use combinations of codes to improve case capture. We will also explore the possibility of developing an algorithm to identify patients with progressive fibrosing ILD, this being a patient group of particular clinical significance.
Source
2020 - 09
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Demographic (Identifiable) (Secondary Uses) — Department of Health and Social Care...
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Email address and mobile phone numbers for patients registered with GP Practices in England to be shared with NHSD as a Processor on behalf of the Department of Health and Social Care (NHS Test and Trace) and NHSDâs Processor, Gov Verify, for the purpose of sending public health messages to the public regarding the use of the COVID-19 App to help protect patients and others. — IG-01237
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 25/09/2020
Purpose for which the data is being used: Email address and mobile phone numbers for patients registered with GP Practices in England to be shared with NHSD as a Processor on behalf of the Department of Health and Social Care (NHS Test and Trace) and NHSDâs Processor, Gov Verify, for the purpose of sending public health messages to the public regarding the use of the COVID-19 App to help protect patients and others.
Dataset: Demographic
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task
National Data Opt-out Applied: Not Applied - As this is a public health message regarding the use of the contract tracing app, with processing being carried out under COPI, the public interest in increasing the wide use of the App which will help contain and manage transmission is considered to justify the overriding of the NDOP
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COVID-19 SitReps (Aggregate (small numbers supressed)) (Secondary Uses) — NHS England / Improvement...
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To support the operational planning and delivery of NHS services in response to COVID-19. — IG-00522_1
Recipient Data Controller Organisation(s) : NHS England / Improvement
Approval Date: 15/09/2020
Purpose for which the data is being used: To support the operational planning and delivery of NHS services in response to COVID-19.
Dataset: COVID-19 SitReps
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Civil Registration Data
Covid-19 Testing Results
Second Generation Surveillance System (SGSS) (Aggregate (small numbers not supressed)) (Secondary Uses) — Department of Health and Social Care...
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The Real-time Assessment of Community Transmission (REACT) study is being carried out to help the Government measure the prevalence of COVID-19. — IG-00502_4
Recipient Data Controller Organisation(s) : Department of Health and Social Care Imperial College London
Approval Date: 16/09/2020
Purpose for which the data is being used: The Real-time Assessment of Community Transmission (REACT) study is being carried out to help the Government measure the prevalence of COVID-19.
Dataset: Civil Registration Data Covid-19 Testing Results Second Generation Surveillance System (SGSS)
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR 9(2)(j) â Scientific research DPA 2018 Part 1 Schedule 1 para 4 â Research
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR 9(2)(j) â Scientific research DPA 2018 Part 1 Schedule 1 para 4 â Research
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Covid-19 Testing Results (Aggregate (small numbers supressed)) (Secondary Uses) — Ministry of Housing...
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To populate and refine the CRIP dashboard - which brings together a range of Covid-19 indicators to give a holistic view of the outbreak at local level. — IG-00834
Recipient Data Controller Organisation(s) : Ministry of Housing, Communities and Local Government
Approval Date: 24/09/2020
Purpose for which the data is being used: To populate and refine the CRIP dashboard - which brings together a range of Covid-19 indicators to give a holistic view of the outbreak at local level.
Dataset: Covid-19 Testing Results
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
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NHS Pathways 111/999 Telephony data (Aggregate (small numbers not supressed)) (Secondary Uses) — Department of Health and Social Care...
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To support analysis related to the COVID-19 NHS Test & Trace Programme and to support the UK and Devolved Governmentsâ responses to the COVID-19 challenge. — IG-00990_2
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 23/09/2020
Purpose for which the data is being used: To support analysis related to the COVID-19 NHS Test & Trace Programme and to support the UK and Devolved Governmentsâ responses to the COVID-19 challenge.
Dataset: NHS Pathways 111/999 Telephony data
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(2)(e)
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data.
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data.
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR
National Data Opt-out Applied: Not Applied - the data is not patient identifiable.
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Maternity Services Data (Identifiable) (Direct Care and Secondary Uses) — NHS England...
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To support the national call/recall for flu and COVID-19 vaccination. — IG-00978_5
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 08/09/2020
Purpose for which the data is being used: To support the national call/recall for flu and COVID-19 vaccination.
Dataset: Maternity Services Data
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care and Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: Implied consent â for a direct care purpose with a clinician only NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: Direct care â implied consent Secondary use - legal obligation
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Shielded Patient List (SPL) (Identifiable) (Direct Care) — Local Authorities...
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To enables Local Authorities to deliver their response to the COVID pandemic for patients on the SPL. — IG-00787_2
Recipient Data Controller Organisation(s) : Local Authorities
Approval Date: 07/09/2020
Purpose for which the data is being used: To enables Local Authorities to deliver their response to the COVID pandemic for patients on the SPL.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Global burden of hip fractures  trends in incidence, post-fracture treatment, and mortality; a multi-country, observational study — James O'Kelly ...
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Global burden of hip fractures  trends in incidence, post-fracture treatment, and mortality; a multi-country, observational study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-24
Organisations:
James O'Kelly - Chief Investigator - Amgen Ltd
James O'Kelly - Corresponding Applicant - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Kevin de Silva - Collaborator - Amgen Ltd
Vaiva Gerasimaviciute - Collaborator - Amgen LtdOutcomes:
Hip fracture episodes; Osteoporosis treatment proportion; Mortality after fracture
Description: Technical Summary
We aim to characterize hip fractures by year among men and women aged 50 years and above within multiple countries. The UK hip fracture patients will be characterised using CPRD linked to the HES and ONS Death Registration Data.
Specific objectives: 1) to estimate the annual incidence of hip fracture; 2) to estimate the proportion of patients having use of a pharmacological treatment for fracture prevention within 12 months following their initial hip fracture by year; 3) to estimate the mortality rate within 12 months following patients initial hip fracture by year.
It is a descriptive cohort study using retrospective electronic health records. Common protocol and an analytical common data model (ACDM) will be used to obtain aggregated data from each national or regional database. The study will consist of annual cohorts of hip fracture patients from each database.
Outcomes: Patient characteristics (age, sex, history of anti-osteoporotic medication use). Annual hip fracture incidence rate (IR), calculated as the sum of all hip fracture episodes divided by the population at-risk. Osteoporosis treatment proportion for new medication users, and by the type of treatment (oral bisphosphonates, parenteral bisphosphonates, denosumab, teriparatide, and others) within 3, 6, and 12 months following the initial fracture by year. Mortality within 3, 6, and 12 months following the initial fracture by year.
Frequency proportions, means and standard deviation, or medians and interquartile range will be used to describe patient characteristics. IRs will be age and sex-standardized using population published by WHO in 2001. A linear regression model will be used to test for time trends in the annual incidence proportion. The age and sex-standardized mortality ratio will be calculated using age-specific mortality in Global reported by WHO.
HES data will be used to determine hospitalizations; ONS Death Registration Data will be used to obtain date of death.
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Incretin-based drugs and the risk of intestinal obstruction among patients with type 2 diabetes — Samy Suissa ...
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Incretin-based drugs and the risk of intestinal obstruction among patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-09
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Astrid Herrero - Collaborator - Montpellier University Hospital
Christel Renoux - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jean-Luc Faillie - Collaborator - Montpellier University Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Romain Altwegg - Collaborator - Montpellier University HospitalOutcomes:
The outcome will consist of a hospitalization for non-mechanical intestinal obstruction (or ileus) or severe constipation requiring a hospitalization. Specifically, the outcome will be defined as a hospitalization with a primary or secondary diagnosis of intestinal obstruction, or a primary diagnosis of constipation, as determined by pre-specified ICD-10 codes.
Description: Technical Summary
Incretin-based drugs, which include glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and dipeptidyl peptidase 4 (DPP-4) inhibitors, are commonly used drugs in the treatment of type 2 diabetes. While these drugs have been shown to have favourable clinical effects, there are concerns that they might increase the risk of intestinal obstruction.
Incretin-based drugs can reduce gastrointestinal motility by either directly binding to GLP-1 receptors in the gut (GLP-1 RAs) or by increasing physiologic levels (DPP-4 inhibitors) of GLP-1. Indeed, several cases of ileus or intestinal obstruction in patients exposed to incretin-based drugs have been reported in postmarketing surveillance. However, to date, no observational study has been conducted to assess this possible association. Thus, the objective of this study is to determine whether use of incretin-based drugs (GLP-1 RAs and DPP-4 inhibitors, separately) are associated with an increased risk of intestinal obstruction, compare with use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Using the Clinical Practice Research Datalink, Hospital Episodes Statistics repository, and Office for National Statistics databases, we will select new users of incretin-based drugs which will be compared with new users of SGLT-2 inhibitors from January 1, 2013 to December 31, 2018, with follow-up until April 30, 2019. Patients will be followed while continuously exposed to the drugs until the occurrence of a hospitalization for intestinal obstruction, death from any cause, end of registration with the general practice, or end of study (April 30, 2019). We will use propensity score fine stratification to control for confounding, and Cox proportional hazard models will be used to estimate the hazard ratios (with 95% confidence intervals) of intestinal obstruction comparing GLP-1 RAs and DPP-4 inhibitors with SGLT-2 inhibitors.
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Anxiety and depression amongst secondary school children: variation across academic years and the relationship with high-stakes examinations — John Jerrim ...
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Anxiety and depression amongst secondary school children: variation across academic years and the relationship with high-stakes examinations
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-13
Organisations:
John Jerrim - Chief Investigator - University College London ( UCL )
John Jerrim - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )Outcomes:
Primary outcome
Our primary outcome of interest is diagnoses or treatment of anxiety/depression (and the time that this occurred). We have defined this outcome drawing upon previous use of the CPRD by other research groups, who have published their READ codes (see below for further details). Precise details on how we intend to define this outcome are provided in the code lists supplied.Secondary outcomes
 Examination stress has previously been linked to eating disorders (Costarelli and Patsai 2012), and often co-occur with anxiety. The same is true of the link between stress and self-harm (Menon et al 2018). We are hence also interested in how stress, eating disorders and self-harm develop across school year groups, and whether such problems are likely to emerge (or re-emerge) around the time that GCSE examinations occur. Likewise, we are also interested in exploring healthcare utilisation amongst young people with anxiety/depression, in order to get some idea about how severity of conditions changes across academic year groups.Description: Technical Summary
This project will investigate the incidence and prevalence of anxiety / depression amongst young people as they progress through secondary school. The primary interest is in when such mental health issues start to emerge and whether there are spikes at certain points in the academic year (particularly around the time that teenagers take their GCSE examinations). The primary outcome of interest is occurrences of anxiety/depression, with secondary outcomes including incidence of eating disorders and self-harm. Academic year group is the main exposure of interest, defined using month and year of birth, which in turn allows us to establish the date when individuals will have sat their GCSE examinations.
The project will begin with a descriptive analysis, illustrating how the risk of suffering anxiety/depression changes as young people progress through secondary school, potentially finding particular academic year groups most at risk of developing such problems. This will include differences between key sub-groups such as girls and young people from advantaged / disadvantaged socio-economic backgrounds. Logistic regression and difference-in-difference analysis will then follow to investigate how diagnoses and treatment of anxiety/depression is related to the timing of national examinations.
Together, the results from the project will provide important new evidence on how mental health is related to young peopleÂs journey through secondary school, and particularly the relationship between anxiety/depression and GCSE examinations.
Source - and 23 more projects — click to show
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Epidemiology of anticoagulants prescribing in non-valvular atrial fibrillation patients in England: a cohort study exploring disease incidence and anticoagulants prescribing trends, comparing clinical outcomes, and risk of recurrent bleeding events — Evangelos Kontopantelis ...
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Epidemiology of anticoagulants prescribing in non-valvular atrial fibrillation patients in England: a cohort study exploring disease incidence and anticoagulants prescribing trends, comparing clinical outcomes, and risk of recurrent bleeding events
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-24
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Alyaa Ajabnoor - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Mamas Mamas - Collaborator - Keele University
Rosa Parisi - Collaborator - University of Manchester
Salwa Zghebi - Collaborator - University of ManchesterOutcomes:
Throughout the different phases of this project we aim to explore the following outcomes:
 Phase 1  The primary outcome is the prescription of OAC drugs including; vitamin K antagonists (VKAs) (acenocoumarol, phenindione or warfarin), or non-vitamin K oral anticoagulants (NOACs) (dabigatran, rivaroxaban, apixaban, or edoxaban).
 Phase 2 - The primary outcome is ischaemic stroke and other thromboembolic events, or the occurrence of major bleeding (MB) defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as (1) clinically overt bleeding accompanied by a drop-in haemoglobin level of least 2 g/dl and/or (2) transfusion of at least 2 units of packed red cells, occurring at a critical site (i.e., intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular, and retroperitoneal) and/or (3) fatal bleeding.1 Secondary outcomes will include clinically relevant non major bleeding (CRNMB) that did not satisfy the ISTH criteria and led to hospitalization, medical or surgical treatment, or led to discontinuation of OACs.
 Phase 3  The primary outcomes include the reoccurrence of MB events or CRNMB for patients who did or did not continue on OACs, the rate of stroke and other thromboembolic events, cardiovascular related mortality, and all-cause mortality. The secondary outcome is the prescription of any OACs after the occurrence of the MB events. We aim to explore the timing of reinitiating OACs from the indexed MB event and weather patients have continued the same OAC before the index haemorrhage event, were switched to another OACs or received lone antiplatelet therapy.All outcomes will be identified over the course of follow-up through the identification of corresponding Read/SNOWMED codes in patients electronic health records. Hospitalization secondary to stroke or bleeding are to be identified through linkage to HES APC using the 10th revision of the International Classification of Diseases (ICD-10). ONS mortality data will be used to ascertain specific causes of death (i.e. bleeding related, cardiovascular, or all-cause death) according to ICD-10 codes.
Description: Technical Summary
Background and Objective:
Atrial fibrillation (AF) significantly increase the risk of ischemic stroke. The optimal use of oral anticoagulants (OACs) and control of stroke-related risk factors, is proven to substantially reduce stroke risk. However, some clinicians may not prescribe OACs to AF patients at-risk for stroke, as they believe that the risk of bleeding outweighs the benefit of anticoagulation. We aim to assess and compare the impact of prescribing anticoagulants by examining OACs prescribing in a cohort of non-valvular atrial fibrillation (NVAF) patients in England.
Methods and Data analysis:
The study comprises of three phases; first an epidemiological study that aims to delineate incidence of NVAF from the CPRD GOLD and Aurum databases between 2009 and 2019. Prescribing of OACs will be assessed for all patients with NVAF and in a sub-group with cancer diagnosis and relevant data will be extracted to identify potential predictors of OACs prescribing and further assessment using multivariable logistic-regression modelling. The second phase will be a comparative cohort study of incident NVAF patients who were classified as âOAC not prescribedâ in phase one, by using a propensity score matching method to match each patient not prescribed OACs to up to 5 comparable patients treated with OACs. Then we aim to compare stroke, bleeding, and all-cause mortality associated with OACs prescribing versus no OACs. The third phase will focus on patients who developed major bleeding events in phase two while taking OACs. We aim to explore the variability of OACs prescribing after bleeding across patient groups and the different predictors for OACs resumption. We will explore the rate of bleeding reoccurrence, stroke, and mortality, and how they relate to OACs prescribing and timing of restarting OACs. We will assess and compare patientsâ risk for stroke and bleeding reoccurrence after the bleeding event using different risk-assessment scores.
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Drug-drug interactions and the risk of sulfonylurea-induced hypoglycaemia — Samy Suissa ...
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Drug-drug interactions and the risk of sulfonylurea-induced hypoglycaemia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Antonios Douros - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Jenny Dimakos - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Wanqi Wang - Collaborator - McGill University
Ying Cui - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Severe hypoglycaemia
Description: Technical Summary
Hypoglycaemia due to the antidiabetic drug class of sulfonylureas is common and potentially severe. Drug-drug interactions involving sulfonylureas may modify the risk of this adverse event. Two commonly used medications that interact with sulfonylureas and could potentially increase the risk of sulfonylurea-induced hypoglycaemia are the oral anticoagulant warfarin and the cardiovascular drug class of beta blockers. Thus, the primary objectives of this study will be to assess (i) whether concomitant use of sulfonylureas with warfarin is associated with an increased risk of severe hypoglycaemia, and (ii) whether concomitant use of sulfonylureas with beta blockers is associated with an increased risk of severe hypoglycaemia. Secondary objectives will assess (i) the comparative risk of severe hypoglycaemia associated with concomitant use of different sulfonylureas with warfarin by classifying sulfonylureas based on their protein binding potential (relevant to the interaction with warfarin), and (ii) the comparative risk of severe hypoglycaemia associated with concomitant use of sulfonylureas with different beta blockers by classifying beta-blockers based on their cardioselectivity (relevant to their hypoglycaemic potential). We will conduct a population-based cohort study of new users of second-generation sulfonylureas using data from the Clinical Practice Research Datalink. The study period will be between April 1998 and June 2020. Severe hypoglycaemia will be defined as hospitalization with or death due to hypoglycaemia. Time-dependent Cox proportional hazards models will estimate hazard ratios and 95% confidence intervals of severe hypoglycaemia associated with concomitant use of sulfonylureas with warfarin or concomitant use of sulfonylureas with beta blockers compared with sulfonylurea use alone. The models will be adjusted for several potential confounders including proxies of disease severity of type 2 diabetes. Sensitivity analyses will address different sources of bias including various approaches (i.e., marginal structural Cox proportional hazards model, prevalent new-user design, active comparator) to account for residual confounding.
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Association Between Opioid Prescriptions and Postoperative Anastomotic Leak After Restorative Proctectomy for Rectal Cancer — Samy Suissa ...
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Association Between Opioid Prescriptions and Postoperative Anastomotic Leak After Restorative Proctectomy for Rectal Cancer
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Marylise Boutros - Collaborator - McGill University
Paul Brassard - Collaborator - McGill University
Richard Garfinkle - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The following outcomes will be measured in this cohort: (1) postoperative anastomotic leak; and (2) prolonged opioid use.
Description: Technical Summary
Postoperative anastomotic leak is the most dreaded complication after restorative proctectomy performed for rectal cancer. Patients with an anastomotic leak are at increased risk of morbidity and mortality, and also experience worse oncologic outcomes. Many risk factors are associated with anastomotic leak, including certain medications such as non-steroidal anti-inflammatory drugs. Opioids represent a potentially interesting exposure for anastomotic leak for which there is little existing research. Animal models have demonstrated an association between opioids and increased tissue concentrations of bacteria and enzymes known to contribute towards anastomotic leak. However, no previous large cohort study has studied the association between opioids and anastomotic leak in colorectal surgery. The primary aim of this study will be to evaluate the association between opioid prescriptions in the year prior to proctectomy and postoperative anastomotic leak. Patients who experience an anastomotic leak are also exposed to additional invasive procedures as part of their treatment, and may experience chronic abdomino-pelvic symptoms secondary to persistent/smoldering pelvic sepsis. As a secondary aim, we will evaluate the association between anastomotic leak and postoperative opioid prescriptions. The proposed study will be a large cohort study using two linked databases. Cohort inclusion criteria will be based on relevant rectal surgery procedures codes and rectal cancer diagnostic codes in the HES inpatient database, and data on opioid prescriptions will be based on opioid prescriptions recorded in CPRD. Multiple logistic regression will be employed to adjust for relevant confounders, and adjusted measures of association, with effect sizes, will be reported.
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Quality and completeness of breast cancer recording in CPRD Aurum compared to CPRD GOLD — Susan Jick ...
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Quality and completeness of breast cancer recording in CPRD Aurum compared to CPRD GOLD
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; No additional NCRAS data required
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-29
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
David Neasham - Collaborator - Amgen Ltd
George Kafatos - Collaborator - Amgen Ltd
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
We will:
⢠compare the proportion of patients who have the following data elements present (yes/no) in their CPRD Aurum record compared to the proportion of patients with these same elements recorded in CPRD GOLD:
o Breast cancer diagnoses
o Breast cancer drug treatment (tamoxifen, aromatase inhibitors)
o Breast cancer surgery (mastectomy, lumpectomy)
o Radiation
o Chemotherapy
o Supporting Clinical Codes that indicate cancer care (e.g. specialist referrals and office visits, cancer care, palliative care)
⢠estimate a breast cancer likelihood classification (Likely, Possible, Unsupported) in CPRD Aurum compared to CPRD GOLD;
⢠calculate crude and age standardized incidence rates of breast cancer in CPRD Aurum compared CPRD GOLD;
⢠calculate correctness (e.g. accuracy, agreement) of breast cancer diagnoses recorded in CPRD Aurum and CPRD GOLD compared to HES (APC and OP) and NCRAS
⢠calculate completeness (e.g. presence or missingness) of breast cancer diagnoses recorded in CPRD Aurum and CPRD GOLD compared to HES (APC and OP) and NCRASDescription: Technical Summary
CPRD is now providing data from a new medical record database, CPRD Aurum. Like CPRD GOLD, CPRD Aurum contains electronic healthcare records entered by GPs to facilitate clinical care; however, CPRD Aurum uses a different GP patient management software, EMIS. Unlike the Vision patient management software that supports CPRD GOLD, EMIS was not developed with the additional intent to provide data for medical research. While these data are sourced from the same UK health care system, it is unknown what, if any, impact the differences in the two software platforms may have on the quality of the data for research purposes.
We will describe the presence of breast cancer diagnosis codes, surgeries, drug treatments (e.g. tamoxifen, aromatase inhibitors), and other cancer care consistent with the treatment of breast cancer and compare the presence of these data elements in CPRD Aurum and CPRD GOLD. We will develop an algorithm to classify the likelihood that patients are âtrueâ breast cancer cases based on presence of these codes. We will estimate and compare crude and age-standardized incidence rates of breast cancer in CPRD Aurum and CPRD GOLD. Amgen researchers will conduct parallel analyses using the same patient population to confirm the findings.
Using the data quality assessment methodologies described by Weiskopf and Weng (Weiskopf 2013), we will estimate correctness and completeness of records in CPRD Aurum and CPRD GOLD compared to those in Hospital Episode Statistics (HES) or in the Cancer Registry (NCRAS). Correctness = the proportion of patients with â¥1 breast cancer diagnosis recorded in CPRD Aurum or CPRD GOLD who also had a breast cancer recorded in HES or NCRAS. Completeness = the proportion of CPRD linked patients with â¥1 breast cancer diagnosis recorded in HES or NCRAS who also had a breast cancer recorded in CPRD Aurum or CPRD GOLD.
Source -
Non-steroidal anti-inflammatory drugs and the risk of myocardial infarction: a nested case-control study in the UK Clinical Practice Research Datalink GOLD — Susan Jick ...
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Non-steroidal anti-inflammatory drugs and the risk of myocardial infarction: a nested case-control study in the UK Clinical Practice Research Datalink GOLD
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-24
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Brenda Baak - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
The outcome of interest in this study will be incident idiopathic MI, which will be identified through Read codes. We will only select idiopathic MI cases, because by including non-idiopathic MI cases one could dilute the potential effect of NSAID use on MI. Idiopathic MI cases will be defined as cases that do not have a code for a proximate cause (e.g., major surgery) or risk factor of MI (e.g., ischemic heart disease, diabetes type 1, see L. Definition of Study Population). MI codes used to select cases will be MI diagnosis codes and MI ECG codes. If patients had a potential MI code within 30 days before the MI diagnosis code or MI ECG code, the date when the potential MI code first occurred will be set as the index date. MI possibly related to surgery or to mural, atrial or ventricular thrombosis will not be considered as an acute MI. Patients who had one of these codes within 30 days after the MI diagnosis or MI ECG code will not be considered as cases.
Description: Technical Summary
The risk of myocardial infarction (MI) associated with NSAIDs was first observed during the long-term clinical trials of rofecoxib (Vioxx), a selective COX-2 inhibitor. Risk of cardiovascular disease in association with NSAID use has since remained a major safety concern. Several epidemiological studies have been conducted on selective and nonselective NSAIDs, and an imbalance of COX-1/COX-2 selectivity and predominant COX-2 inhibition have been proposed as an explanation for the increased risks of MI found among NSAID users. It is generally acknowledged that certain COX-2 inhibitors can increase the risk of MI, but results for traditional NSAIDs remain inconclusive.
Our primary aim is to evaluate the association between NSAID use and risk of MI among patients without major risk factors in the CPRD GOLD. We plan to conduct a nested case-control analysis in a population of NSAID users to reduce protopathic and indication bias. Firstly, we will select all patients aged 40-79 years old who had received at least one NSAID prescription. From this base population, we will select all cases without major risk factors who had a first MI between 2006 and 2019. Cases will be matched to up to four controls based on age, sex, general practice, and calendar year. We will use conditional logistic regression to estimate crude and adjusted odds ratios with 95% confidence intervals of MI among current and recent NSAID users, compared with past NSAID users. Odds ratios derived from this nested case-control study will estimate the risk ratio. As a secondary aim we will estimate crude and adjusted odds ratios of MI according to the number of NSAID prescriptions and types of NSAIDs prescribed among current and recent users of each individual NSAID, compared to past users of any NSAID.
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Safety of non-steroidal anti-inflammatory drug (NSAID) prophylaxis when initiating urate-lowering therapy for gout: an observational study in UK primary care using the Clinical Practice Research Datalink — Edward Roddy ...
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Safety of non-steroidal anti-inflammatory drug (NSAID) prophylaxis when initiating urate-lowering therapy for gout: an observational study in UK primary care using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-24
Organisations:
Edward Roddy - Chief Investigator - Not from an Organisation
Sara Muller - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Harry Forrester - Collaborator - Keele University
Lorna Clarson - Collaborator - Not from an Organisation
Ram Bajpai - Collaborator - Keele University
Rebecca Whittle - Collaborator - Keele University
Richard Partington - Collaborator - Keele UniversityOutcomes:
Gastrointestinal, cardiovascular, and renal adverse events associated with NSAIDs that are serious enough to warrant seeking healthcare.
Description: Technical Summary
Gout affects 2.5% of adults in the UK and causes flares of severe joint pain and swelling. Long-term treatment for gout involves taking urate-lowering drugs (e.g. allopurinol) to prevent flares. However, allopurinol initiation commonly triggers a gout flare, hence co-prescription of prophylactic colchicine or NSAIDs to prevent flares is recommended. There is little evidence concerning the safety of NSAID prophylaxis when initiating allopurinol and we are currently conducting a similar study to this one to assess the risks associated with colchicine prophylaxis (protocol number 19_233).
We will describe the safety of NSAID prescriptions when initiating allopurinol treatment for gout.
The specific objective is to determine, in patients with gout commencing allopurinol, the risk of NSAID-related adverse events severe enough to warrant seeking healthcare.
The study will be undertaken using linked primary care and Hospital Episode Statistics data.
In a matched, retrospective cohort study, the incidence of NSAID-related adverse events (gastrointestinal, cardiovascular, and renal) will be compared using Cox proportional hazards regression between patients with gout initiating allopurinol who are prescribed and not prescribed NSAID prophylaxis. Matching will be based on propensity scores.
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Understanding the prevalence and characteristics of frequent attenders in general practice using the Clinical Practice Research Datalink — Darren Ashcroft ...
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Understanding the prevalence and characteristics of frequent attenders in general practice using the Clinical Practice Research Datalink
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-16
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Tracey Farragher - Corresponding Applicant - University of Manchester
Aneez Esmail - Collaborator - University of Manchester
Claire Planner - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Luke Munford - Collaborator - University of Manchester
Maria Panagioti - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
The primary outcome will be Persistent Frequent Attenders (PFA) defined as those in the top 10% of age and gender-adjusted attendance over three years, collated for each registered patient every quarter within the timeframe (2000-2019). The secondary outcome will be number of GP attendances per patient per financial year over the timeframe, to understand the underlying variation in the number of GP attendances from which the primary outcome is derived.
Description: Technical Summary
UK Primary Care is facing significant challenges: increasing demand with more complex consultations, as a result of an aging population, and a GP recruitment and retention crisis. We need to understand and adjust our practice to increase system efficiencies and decrease healthcare expenditures, while improving patient experience and safeguarding patient care.
In this challenging context, a small group of patients use a disproportionate amount of GP resources. It has been estimated that the top 10% of attenders make up 30-50% of GP workload. Frequent Attenders (FA) have been found to have different clinical and psychosocial characteristics to ÂNormal Attenders (NA), although UK evidence is limited.
Using CPRD GOLD and Aurum, we aim to understand the prevalence and nature, identifying factors, of frequent attendance to GPs in the UK, to inform methods of addressing unmet needs that may act as drivers for improvement.
First, we will describe the distribution of consultations (by all staff/GPs and by face to face/all consultations) within each practice and explore if that has changed over time and become more inequitable. Cost implications for each practice will also be explored.
Multi-level models will estimate the trends in frequent attendance over time, quantify variability over time and across age, gender, multimorbidity, frailty, practice, region and deprivation. These models will take account of the longitudinal nature of the data and both the patient and practice level factors that might account for the variation and trends. These models will identify which patient and practice characteristics are associated with the number of attendances and FAs.
Clusters within the FA group will be explored, using k-means and hierarchical clustering. Assuming meaningful clusters will be identified, we will attempt to characterise them and link them to specific actions and interventions, aiming to meet patient care needs while reducing the frequency of their consultations.
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The impact of the quality and accessibility of primary health care on avoidable mortality: a longitudinal comparison of people with intellectual disabilities and the general population — Laura Hughes...
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The impact of the quality and accessibility of primary health care on avoidable mortality: a longitudinal comparison of people with intellectual disabilities and the general population
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-08
Organisations:
Laura Hughes-McCormack - Chief Investigator - University of Glasgow
Laura Hughes-McCormack - Corresponding Applicant - University of Glasgow
- Collaborator -
Bhautesh Jani - Collaborator - University of Glasgow
Chris Hatton - Collaborator - Lancaster University
Daniel Mackay - Collaborator - University of Glasgow
Donald Lyall - Collaborator - University of Glasgow
Gillian Smith - Collaborator - University of Glasgow
Gyles Glover - Collaborator - Public Health England
Iain Carey - Collaborator - St George's, University of London
Jill Pell - Collaborator - University of Glasgow
Maria Truesdale - Collaborator - University of Glasgow
Srinivasa Vittal Katikireddi - Collaborator - University of GlasgowOutcomes:
Primary outcomes:
 death (all cause)
 death (avoidable causes)
o amenable causes
o preventable causesSecondary outcomes:
 primary health care access (consultation factors; frequency, length and continuity of care)
 primary health care quality (QOF)Description: Technical Summary
Background:
There is currently limited information on primary care health care quality, access or utilisation in people with intellectual disabilities (ID) and no research to date has focussed on the relationship to amenable mortality compared to the general population.Aim:
To quantify how primary care quality and access impacts on avoidable mortality in people with ID, including person level characteristics as potential covariates.Design:
A longitudinal cohort study which will identify a cohort of individuals with ID with a matched general population reference cohort.Cohort:
Individuals with ID aged 0-75 registered for at least six months in CPRD participating practices during 2006-2020 and a matched (sex, year of birth, deprivation) reference cohort (3 matches per person with ID) without ID.Variables:
Independent variables
Quality and accessibility of primary care will be investigated using a mixture of Quality and Outcomes Framework (QOF) and non-QOF indicators, including the management of diagnosed QOF conditions measured from clinical indicators as well as consultation factors (e.g. frequency, length and continuity of consultations).Outcome variables
Deaths from avoidable causes (amenable/ preventable deaths)Other variables (not mentioned above)
Age (0-9, 10-18, 19-24, 25-44, 45-64, 65-74); gender; deprivation (living situation domains); severity of ID; living situation; ethnicity (white, Asian, Chinese, black, mixed/other, unknown); diagnosis of any ambulatory care conditions in GP records.Statistical methods:
Survival analysis. Stratified (by sex, birth year group, and deprivation) Cox proportional hazards (PH) regression models, testing for both a) multiplicative and b) additive interactions.Sensitivity analyses:
As uncertainty exists in all aspects above, pre-specified sensitivity analyses will be conducted.Impact:
Strengthen policy guidance to improve NHS practice around primary care management of people with ID through changes in indicators in the QOF or through informing local enhanced services (LESs) on evidence based best practice in primary care.
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Musculoskeletal adverse outcomes after treatment with aromatase inhibitors for breast cancer — Daniel Prieto...
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Musculoskeletal adverse outcomes after treatment with aromatase inhibitors for breast cancer
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-29
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Jennifer Lane - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University HospitalsOutcomes:
Outcome will be defined as the first incident CTS, tendinopathy or osteoarthritis record within the CPRD database. Outcome cohorts will be identified using OMOP CDM codes for diagnoses, based upon some codes that have been previously validated in datasets included in OHDSI, but also using the ATLAS diagnostics tool to investigate orphan codes.[1,2] Cohort entry and exit is defined as per the time at risk window: entry is at the index date, exit at date of death or migration, date of outcome, loss to follow up or where possible, 1825 and 3650 days after the index date.
Negative control outcomes
Negative control outcomes will be added into the analysis in order to investigate the validity of the propensity score adjustment for confounding (Appendix 3)
In order to undertake this subsequent analysis for the competing risk of mortality in this cohort, mortality will also be used as an outcome in this study.Description: Technical Summary
Objectives: To investigate if there is an association between aromatase inhibitor (AI) use compared to tamoxifen and the incidence of carpal tunnel syndrome (CTS), tendinopathy of the wrist, shoulder, Achilles tendon and osteoarthritis (OA) of the hand, shoulder, hip and knee in post- menopausal women treated for breast cancer.
Design
Cohort study using non-identifiable CPRD data mapped to the OHDSI Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) to evaluate the risk of adverse musculoskeletal events in post-menopausal women taking AI compared to tamoxifen to treat hormone receptor positive breast cancer. Study undertaken using OMOP CDM as planned replication in other international datasets, and to enable comparison between countries.Participants
All post-menopausal (defined as over 55 years old) women with an incident diagnosis of breast cancer treated with either AI or tamoxifen. Those with a prevalent cancer, hormone receptor negative breast cancer (where possible to determine), breast cancer not treated with AI or tamoxifen, or an outcome event prior to breast cancer date of diagnosis are excluded.Variables and Measurements
Drug exposure will be determined from the first recorded drug exposure; outcomes will be defined as the first incident event for each individual outcome (based upon the code list given in the appendix, generated in the OHDSI CDM using the Atlas tool).Propensity score adjustment of patients will be undertaken to minimise confounding (with the choice of propensity score adjustment between matching and stratification made a priori). Cumulative incidence of outcomes will be plotted; cox proportional hazards modelling to estimate hazard ratios for each of the outcomes according to drug use.
Expected results
Incidence of adverse musculoskeletal outcomes at a population level associated with AI treatment in comparison to tamoxifen in post-menopausal women.
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ALETHEIA: An observational study on treatment patterns and clinical outcomes of patients experiencing a myocardial infarction in clinical practice — Eva Lesen ...
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ALETHEIA: An observational study on treatment patterns and clinical outcomes of patients experiencing a myocardial infarction in clinical practice
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-07
Organisations:
Eva Lesen - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Mai Duong - Corresponding Applicant - Evidera, Inc
Chris Hewitt - Collaborator - Astra Zeneca Ltd - UK Headquarters
Dimitra Lambrelli - Collaborator - Evidera, Inc
Jason Simeone - Collaborator - Evidera, Inc
Sharon MacLachlan - Collaborator - Evidera, IncOutcomes:
This is a descriptive study, so patient characteristics will be summarised for patients initiating ticagrelor 60 mg or other P2Y12 inhibitors (clopidogrel, prasugrel, or ticlopidine) 12 months after MI in the UK.
Additionally, as NICE has recently recommended ticagrelor 60 mg for the prevention of atherothrombotic events in adults with MI at high risk of a future event,1 we will also investigate treatment persistence, bleeding complications requiring hospitalisation, and CV events among these patients. The following outcomes are of interest:
 Persistence to treatment: measured as time to discontinuation (see more details in section N)
 Bleeding requiring hospitalisation: hospitalisation for intracranial haemorrhage, gastrointestinal bleeding, or other bleeding.
 Bleeding events (code lists attached in appendices)
o Intracranial haemorrhage
o Gastrointestinal bleeding requiring hospitalisation
o Bleeding other than intracranial haemorrhage or gastrointestinal bleeding requiring hospitalisation
o Fatal bleeding (overall, intracranial, gastrointestinal, other)
o Bleeding not requiring hospitalisation, here denoted minor bleeding
 CV events (code lists attached in appendices)
o Composite of hospitalisation for MI or stroke, and all-cause mortality
o Composite of hospitalisation for MI or stroke, and CV death (three-point major adverse CV events [MACE])
o Hospitalisation for MI, hospitalisation for ischaemic stroke, CV death, coronary heart disease (CHD) death, all-cause mortality, coronary revascularization (composite of percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG]) assessed individually
 Dyspnoea
 Lower-limb amputationDescription: Technical Summary
According to the British Heart Foundation, the prevalence of myocardial infarction (MI) in England in 2011 was 3.7% in men and 1.6% in women. It is estimated that better secondary prevention after MI could prevent more than 30,000 deaths per year in England and Wales. Most guidelines recommend 12-month DAPT with aspirin (ASA) and an oral P2Y12 inhibitor, a group of antiplatelets that inhibits the platelet P2Y12 receptor, as the mainstay of antithrombotic therapy after MI, and clinical guidelines have recently recommended extending DAPT beyond 12 months. However, there is a lack of real-world data on patient characteristics and antiplatelet treatment beyond 12 months of MI.
This is an observational cohort study aiming to describe the characteristics of patients initiating ticagrelor 60 mg and other P2Y12 inhibitors 12 months after MI in England, using data from Hospital Episode Statistics (HES) linked to the Clinical Practice Research Datalink (CPRD) Gold and Aurum. Additionally, we will investigate the treatment persistence, incidence and event rates of bleeding requiring hospitalisations, CV events in patients receiving ticagrelor 60 mg. Patient characteristics will be summarised for each treatment group using descriptive statistics. Median treatment duration of ticagrelor 60 mg and cumulative incidence of clinical outcomes will be calculated using the Kaplan-Meier method. Incidence rates and event rates will be calculated per 100 person-years.
This study would inform healthcare professionals and health authorities on how closely clinical practice in England follows current NICE guidelines, which in turn can lead to improved treatment in patients with MI. It will also offer insight into risks and benefits of ticagrelor 60 mg, providing clinical practice with evidence of the benefits and safety of the new therapy, and guiding physicians to better evidence-based treatment decisions. This knowledge can improve the overall treatment pathway and protect vulnerable patient populations from avoidable risks.
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Fertility rates and pregnancy outcomes in women with psoriasis and psoriatic arthritis: a population-based cohort study — Darren Ashcroft ...
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Fertility rates and pregnancy outcomes in women with psoriasis and psoriatic arthritis: a population-based cohort study
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-07
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Teng-Chou Chen - Corresponding Applicant - University of Manchester
Christopher Griffiths - Collaborator - University of Manchester
Elise Kleyn - Collaborator - University of Manchester
Ireny Iskandar - Collaborator - University of Manchester
Matthias Pierce - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
Outcome 1 Â Fertility rates per year
 Pregnancy rates (live births, still births and miscarriages)
 Live birth ratesOutcome 2  Pregnancy outcomes
 Gestational diabetes
 Antenatal haemorrhage
 Venous thromboembolism during pregnancy
 Preeclampsia or evidence of preeclampsia (e.g. gestational hypertension)Outcome 3  Birth outcomes
 Maternal death
 Post-natal mental illness (e.g. depression or psychosis)
 Pre-term birth (<37 weeks vs. ?37 weeks of gestation)
? Moderate pre-term (32-36 weeks of gestation)
? Very pre-term (<32 weeks of gestation)
 Live births, still birth and miscarriages
 Low birth weight (<2500g vs. ?2500g)
 Mode of delivery (elective or emergency caesarean section compared to normal delivery)
 Neonatal deathDescription: Technical Summary
Psoriasis and psoriatic arthritis (PsA) are chronic inflammatory disorders that are associated with a number of co-morbidities including obesity, metabolic syndrome, cardiovascular disease, psychiatric diseases and other inflammatory diseases, such as inflammatory bowel disorders. Psoriasis and PsA are known to have a considerable psychosocial impact which may affect personal relationships and social interactions as well as result in maladaptive coping mechanisms and unhealthy lifestyle behaviours including smoking and alcohol excess.
Almost 50% of patients affected with psoriasis and PsA are women in whom the average age of onset of the disease is before 40 years of age, coinciding with the peak reproductive years. This overlap may pose specific challenges. Specifically, psoriasis and PsA have been negatively associated with sexual function, which may affect the fertility rate in women affected with these conditions. Furthermore, the comorbidities and the unhealthy lifestyle behaviours associated with psoriasis and PsA have been associated with adverse pregnancy and birth outcomes.
Despite this, studies examining fertility rate, pregnancy and birth outcomes in women with psoriasis and PsA are scarce, typically of small size including less than 100 women, and have reported conflicting results. Therefore, this study aims to generate evidence relating to trends in the fertility rate and risk of adverse pregnancy and birth outcomes in mothers with psoriasis or PsA compared to those without the diseases using data obtained from CPRD GOLD. Fertility rate ratios and odds ratios for adverse pregnancy and birth outcomes among women with psoriasis or PsA will be estimated from logistic regression models by comparing to women without the diseases. Findings from this study will add to the limited existing knowledge, thus, providing patients and clinicians, including general practitioners, dermatologists, rheumatologists and obstetricians, with guidance to ensure these patients and their offspring achieve optimal outcomes.
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The care home residency population in the United Kingdom: osteoporosis-related characteristics, outcomes, and patterns of care  a descriptive study — James O'Kelly ...
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The care home residency population in the United Kingdom: osteoporosis-related characteristics, outcomes, and patterns of care  a descriptive study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-06
Organisations:
James O'Kelly - Chief Investigator - Amgen Ltd
James O'Kelly - Corresponding Applicant - Amgen Ltd
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Mathew McDermott - Collaborator - Amgen Ltd
Natalie Eugene - Collaborator - Amgen Ltd
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Vaiva Gerasimaviciute - Collaborator - Amgen LtdOutcomes:
Osteoporosis diagnosis; Osteoporosis treatment; Type of osteoporosis treatment (including bisphosphates, denosumab, raloxifene, teriparatide, strontium ranelate)Â The updated list of osteoporosis treatments includes currently relevant and most common treatments: bisphosphates, denosumab, raloxifene, teriparatide, and strontium ranelate.; Fracture incidence rate; Treatment with antiresorptive therapy within 12 months after the fracture; Hospitalisation; Transfer to intermediate care; Mortality after fracture; Persistence to osteoporosis treatment
Description: Technical Summary
We aim to describe the characteristics of people who live in care homes in the UK using primary-care electronic health record (EHR) data from CPRD and linked Hospital Episode Statistics (HES) in terms of osteoporosis-related characteristics, outcomes, and patterns of care.
Specific objectives: 1) to describe demographic and clinical characteristics, in terms of risk factors for fracture; 2) to describe patterns of osteoporosis care; 3) to estimate the annual fracture incidence rate in 2012-2019; 4) to describe post-fracture management and outcomes; 5) to investigate persistence to osteoporosis treatment among new users of antiresorptive therapies. Exploratory aim - to assess recording and coding of Dual energy x-ray absorptiometry (DXA).
Outcomes:
a) in the whole care home population: 1) demographic and clinical characteristics; 2) number of people with osteoporosis diagnosis and prescribed osteoporosis treatment, types of osteoporosis treatment; 3) fracture incidence rate; 4) number of individuals with falls and proportion of them resulting in fractures; and 5) DXA. Outcomes (1) and (3) will also be measured in a matched cohort from the general population (matched on age, sex, calendar period and GP practice).
b) among those with a fracture (first fracture after the index): 1) proportion of individuals who received antiresorptive therapy (and by type) within 12 months after the fracture; 2) proportion of fractures resulting in osteoporosis diagnosis; 3) hospitalisation; 4) transfer to intermediate care; and 5) 1-year post-fracture mortality.
c) in the population with osteoporosis treatment initiation after index: cumulative incidence of non-persistence to treatment.
This is a descriptive study: summary statistics will be used for the data analysis (eg, means, medians, proportions). We will also present descriptive statistics for a matched general population cohort to put the results from the care home population into context.
HES and ONS data will be used to determine hospitalizations and date of death.
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Mode of delivery for childbirth in the UK Clinical Practice Research Datalink (CPRD) and Hospital Episodes Statistics (HES), 1998-2020: investigating the usability, completeness and temporal trends in mode of delivery data — Harriet Forbes ...
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Mode of delivery for childbirth in the UK Clinical Practice Research Datalink (CPRD) and Hospital Episodes Statistics (HES), 1998-2020: investigating the usability, completeness and temporal trends in mode of delivery data
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-23
Organisations:
Harriet Forbes - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Deborah Anne Lawlor - Collaborator - University of Bristol
Jennifer Campbell - Collaborator - CPRD
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Melanie Griffin - Collaborator - University of Bristol
Sadie Mullin - Collaborator - University of BristolOutcomes:
Primary outcome: An algorithm that will derive mode of delivery (Non-instrumental VD, Instrumental VD, Elective CS, Emergency CS). A further outcome is testing the validity of this derived variable.
Secondary outcomes: Using the algorithm to derive, and testing the validity of, both a cruder (binary) and more refined 21 level categorical variable of mode of delivery, and the World Health Organisations RobsonÂs classification system (which was developed as a global standard for assessing, monitoring and comparing CS rates)1:
- Binary mode: VD or CS
- Delivery with finer categories:
0=VD vertex (top of the babyÂs head comes first)
1=VD other cephalic, unassisted*
2=VD other cephalic, assisted*
3=VD other cephalic, assistance unspecified*
4=VD breech, unassisted*
5=VD breech, assisted*
6=VD breech, assistance unspecified*
7=VD presentation unspecified, unassisted*
8=VD presentation unspecified, assisted*
9=VD presentation and assistance unspecified*
10=VD instrumental, low forceps
11=VD instrumental, high/mid forceps
12=VD instrumental, unspecified forceps
13=VD instrumental, vacuum
14=Elective CS, upper uterine segment (UUS)
15=Elective CS, lower uterine segment (LUS)
16=Elective CS, unspecified
17=Emergency CS, UUS
18=Emergency CS, LUS
19=Emergency CS, unspecified
20=CS Unspecified
21=Other
*Assisted refers to manual manipulation by a healthcare professionalAdditional outcome: Planned (as opposed to actual) mode of delivery.
Description: Technical Summary
The CPRDÂs pregnancy register is a database of more than 5.8 million pregnancies, including 833,165 pregnancies ending in a delivery, between 1998 and 2020. This large-scale register is a valuable resource for researchers interested in pregnancy related epidemiological questions. The register contains information on the pregnancy, including its outcome (live birth, still birth or early pregnancy loss), the timing of the pregnancy (the estimated start and end date), and additional details such as whether it was a singleton or multiple pregnancy. The register currently does not provide information on whether the delivery was a vaginal delivery (VD), an instrumental VD, or emergency or elective Caesarean section (CS), which is a key variable for understanding the health effects of CS and instrumental VD, particularly in the context of increasing rates of CS. We therefore aim to enhance the pregnancy register by developing an algorithm to define mode of delivery, using hospital data and primary care data. We will analyse the completeness of mode of delivery data, use CohenÂs Kappa statistic to estimate the level of agreement between delivery data from different sources and calculate the rate of indications for, and complications of, deliveries to assess the dataÂs reliability. Finally, we will describe how delivery methods have changed over time.
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Quality and completeness of rheumatoid arthritis (RA) diagnosis in CPRD GOLD and CPRD AURUM — Susan Jick ...
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Quality and completeness of rheumatoid arthritis (RA) diagnosis in CPRD GOLD and CPRD AURUM
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-17
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
David Neasham - Collaborator - Amgen Ltd
George Kafatos - Collaborator - Amgen Ltd
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Todd Sponholtz - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
We will:
⢠compare the proportion of patients who have the following data elements present (yes/no) in their CPRD Aurum record compared to the proportion of patients with these same elements recorded in CPRD GOLD:
o RA diagnoses
o RA drug treatment
o Analgesic prescriptions
o RA labs
o Supporting Clinical Codes that indicate RA (e.g. specialist referrals and office visits, monitoring for RA drugs, RA symptoms, and disease activity)
⢠estimate an RA likelihood classification (Likely, Possible, Unsupported) in CPRD Aurum compared to CPRD GOLD;
⢠calculate crude and age standardized incidence rates of RA in CPRD Aurum compared CPRD GOLD;
⢠calculate completeness of RA diagnoses recorded in CPRD Aurum and CPRD GOLD compared to HES (APC and OP)These outcomes will also be compared by time period (2005-2009, 2010-2019) to reflect the changes in the NICE guidelines over time.
Description: Technical Summary
CPRD is now providing data from a new medical record database, CPRD Aurum, which encompasses data on over 900 practices and 30 million patients. Like CPRD GOLD, CPRD Aurum contains electronic healthcare records entered by GPs to facilitate clinical care; however, CPRD Aurum uses a different GP patient management software, EMIS. Unlike the Vision patient management software that supports CPRD GOLD, EMIS was not developed with the additional intent to provide data for medical research. While CPRD GOLD and Aurum data are sourced from the same UK health care system, it is unknown what, if any, impact the differences in the two software platforms may have on the quality of the data for research purposes.
We will describe the presence of codes for RA diagnoses, tests, and treatments consistent with a diagnosis of RA, based on NICE guidelines, and compare the presence of these elements in CPRD Aurum and CPRD GOLD. We will develop an algorithm based on the presence of diagnoses, prescriptions, and/or supporting clinical codes to classify the likelihood that the patient is a âtrueâ RA case based on the codes present in their CPRD Aurum and CPRD GOLD electronic records. Amgen researchers will conduct parallel analyses using the same patient population to confirm the findings.
Using the data quality assessment methodologies described by Weiskopf and Weng (Weiskopf 2013), we will estimate completeness of records in CPRD Aurum and CPRD GOLD compared to those in Hospital Episode Statistics (HES). Completeness estimates the presence or missingness of a diagnosis. Completeness will be calculated as the proportion of patients with â¥1 RA diagnosis recorded in HES who also have RA recorded in CPRD Aurum or CPRD GOLD.
Finally, we will estimate and compare crude and age-standardized incidence rates of RA in CPRD Aurum and CPRD GOLD.
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Epidemiological investigations of the role of viral infections, viral treatments, vaccination prevention and the risk of dementia — Darren Ashcroft ...
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Epidemiological investigations of the role of viral infections, viral treatments, vaccination prevention and the risk of dementia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-24
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Artitaya Lophatananon - Corresponding Applicant - University of Manchester
Kenneth Muir - Collaborator - University of Manchester
Krisztina Mekli - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
The primary outcome will be the first event of dementia and its subtypes (AlzheimerÂs Disease, Vascular Dementia and Frontotemporal Dementia). Dementia outcome will be identified either in CPRD, HES or ONS.
The secondary outcome will be death registration caused by dementia. Dementia death will be identified from ONS records.
Description: Technical Summary
Many studies using a range of approaches, including immunological, biological, epidemiological and GWAS (Genome-Wide Association Studies) in total approaching about 200 have implicated a range of viruses in the development of AlzheimerÂs disease (AD) and dementia including herpes simplex virus (HSV)1,2 and zoster herpes virus (ZHV). We proposed to investigate if these viruses, treatments and immunisations associate with dementia outcomes. A matched cohort design will be used.
Adult patients (50 years or older) with a Read /SNOMED coded diagnosis of specific infection between 1998-2018 and eligible for linkage to HES and ONS records will be matched (on age, gender and practice) with up to 10 comparison patients without the infection diagnoses. Selection will be restricted to patients registered with a contributing practice for at least one year and follow-up will end when the patient either dies, transfers out of the practice, last data collection, the end of the study period, or experiences the outcome of interest. The outcome is the first diagnosis of dementia record through CPRD, HES and ONS. Cox regressions will be used to investigate whether 1) patients exposed to infections (herpes simplex HSV1, 2 or zoster herpes virus ZHV) have a higher risk of dementia compared to those not exposed to these infections; 2) among those infected with the viruses, whether the those treated vs not treated have a reduced risk of dementia/AD; 3) investigate the association between ZHV immunisation and dementia/AD risk.
In the statistical model, adjustment will be made for smoking, alcohol, BMI and Charlson comorbidity index (CCI). Missing data will be accounted for using multiple imputation.
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Assessment of Prevalence and Risk Factors for Psychiatric Morbidity after Restorative Proctectomy for Rectal Cancer  A Population-Based Cohort Study — Samy Suissa ...
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Assessment of Prevalence and Risk Factors for Psychiatric Morbidity after Restorative Proctectomy for Rectal Cancer  A Population-Based Cohort Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-07
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Jeongyoon Moon - Collaborator - McGill University
Marylise Boutros - Collaborator - McGill University
Paul Brassard - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The following outcomes will be measured in this cohort: (1) psychiatric morbidity; (2) mortality attributed to psychiatric cause. Each of these outcomes will be operationally defined using read-codes and ICD10 codes for relevant diagnoses and prescriptions recorded in CPRD GOLD and HES.
Description: Technical Summary
The most common operation performed for rectal cancer is a restorative proctectomy. While this operation avoids a permanent ostomy, many patients (~70%) are left with significant bowel dysfunction (e.g., frequency, urgency, and incontinence) that impairs their quality of life. Furthermore, patients may experience urinary and sexual dysfunction, both of which can be consequences of pelvic surgery and radiotherapy. The purpose of this study is to assess the psychiatric morbidity of patients who have undergone restorative proctectomy for rectal cancer, as well as to identify risk factors for developing psychiatric morbidity, namely the presence of bowel dysfunction and sexual/urinary symptoms after restorative proctectomy, using population-level data.
This will be a large cohort study making use of two linked databases. Cohort inclusion criteria will be based on relevant rectal surgery procedures codes in the HES database. Variables of interest, including bowel dysfunction and sexual/urinary dysfunction will be defined using symptom read-codes recorded in CPRD. Outcomes including psychiatric morbidity and mortality will be defined using diagnosis codes, prescription product codes, and health service in HES and CPRD. The cohort will be described using demographic, patient, and disease characteristics. A Cox proportional hazards model will be used to estimate the risk of psychiatric morbidity and mortality adjusting for potential confounders. The principal exposures of interest will include pre-existing psychiatric morbidity, postoperative complications and presence of bowel and/or sexual, urinary dysfunction. Sensitivity analyses will be performed to test the robustness of our results, focusing primarily on outcome classification.
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Metformin and the risk of multiple sclerosis: A population based cohort study — Michael Martinec ...
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Metformin and the risk of multiple sclerosis: A population based cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-27
Organisations:
Michael Martinec - Chief Investigator - Roche
Samantha Wilkinson - Corresponding Applicant - Roche
Erwan Muros-Le Rouzic - Collaborator - Roche
Iori Namekawa - Collaborator - Roche
Isaac Gravestock - Collaborator - Roche
James Overell - Collaborator - Roche
Li Su - Collaborator - University of Cambridge
Lynette Foo - Collaborator - Roche
Shaun Seaman - Collaborator - University of CambridgeOutcomes:
Incidence of Multiple Sclerosis.
Description: Technical Summary
Researchers are increasingly interested in repurposing already available drugs for neurodegenerative diseases. Metformin is a widely prescribed first-line therapy for type 2 diabetes. It is an inexpensive, generally well tolerated and effective medication for normalizing hyperglycemia in individuals with obesity and metabolic syndrome.
Here, we plan to estimate the effect of initiating metformin on the risk of MS using Electronic Health Records (EHRs) from the United Kingdom (UK). We will apply Target Trial Emulation methodology to answer our comparative questions. This work will also contribute to the methodological literature by improving statistical methods for implementing target trial emulations.
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Estimating the effects of early intervention services for first-episode psychosis and model fidelity on hospitalisations: a quasi-experimental study — Samy Suissa ...
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Estimating the effects of early intervention services for first-episode psychosis and model fidelity on hospitalisations: a quasi-experimental study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-21
Organisations:
Samy Suissa - Chief Investigator - McGill University
Rebecca Fuhrer - Corresponding Applicant - McGill University
Ashok Malla - Collaborator - McGill University
David Stephens - Collaborator - McGill University
Miriam Kinkaid - Collaborator - McGill University
Sam Harper - Collaborator - McGill University
STEPHEN MCGOWAN - Collaborator - NHS EnglandOutcomes:
Absolute difference in hospitalisation rate; mean days (or weeks) of hospitalisation
Description: Technical Summary
The objective of this research is to estimate the effects of early intervention for psychosis (EIP) services and EIP services âfidelityâ (i.e. the degree to which an EIP service is delivering care as intended) on two outcomes: the rate of and length of stay in inpatient psychiatric hospitalisations among people experiencing their first psychosis episode in England. Using a quasi-experimental study design, we will compare hospitalisation outcomes in Strategic Health Authority (SHA) regions that vary in exposure to EIP services over time, specifically, the number of EIP teams in each region. Whether the level of EIP âfidelityâ in the region is an effect measure modifier of these relationships will also be examined. We will define a cohort of people who experienced their first episode of psychosis between 2002 and 2013 in the Clinical Practice Research Datalink (CPRD) and the Hospital Episodes Statistics (HES) database. The HES will also provide data on the hospitalisation outcomes of interest. Using data from a national survey of EIP teams, we will derive a series of aggregate, time-varying exposures (number of EIP teams) and effect measure modifier (fidelity) variables, at the level of the SHA, each year. We will use fixed-effects Poisson and linear regression models to estimate the effects of EIP on the two hospitalisation outcomes and examine effect measure modification by EIP fidelity level in the SHAs. The fixed-effects approach allows us to control confounding by often difficult or impossible to measure stable, region-level characteristics. This research will estimate the impact of EIP services on patient hospitalisations across England and provide insight into how fidelity of EIP services influences these outcomes. This in turn, will be useful in informing service delivery and policy at a national level.
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Mapping the prevalence of Chronic Venous Disease in England — Alun Davies ...
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Mapping the prevalence of Chronic Venous Disease in England
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-03
Organisations:
Alun Davies - Chief Investigator - Imperial College London
Safa Salim - Corresponding Applicant - Imperial College London
Alun Davies - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Roberto Fernandez-Crespo - Collaborator - Imperial College London
Sarah Onida - Collaborator - Imperial College LondonOutcomes:
Prevalence of CVD: Overall CVD prevalence and prevalence in different severity groups according to the CEAP severity stages will be measured.
Prevalence of CVD in geographical and socioeconomic groups: Geographical region will be measured using region specific patient demographic information in CPRD. Social deprivation will be measured using Patient Level Index of Multiple Deprivation in CPRD. Patient characteristics, and possible risk factors to be evaluated, include age, gender, body mass index (BMI), ethnicity, personal history of venous thromboembolism (VTE) or superficial vein thrombosis (SVT), family history of CVD, smoking status, alcohol consumption, occupation, constipation (or low fibre intake), high systolic blood pressure, history of previous surgery at the site of venous disease, socioeconomic deprivation and depression, and for women parity, hormonal treatments and menopause. These risk factors will either be identified through specific CPRD patient demographic information or through separate Read codes.
Progression of CVD: Progression/deterioration of CVD will be defined as a patient moving from a lower CEAP stage to a higher CEAP stage over time e.g. (C2 to C3, C3 to C4, C4 to C5/6, C2 to C4, C2 to C5/6, C3 to C5/6). Codes for each of these stages have been identified. Patients with no progression or low stage progression e.g. (C2 to C3, C3 to C4, C4 to C5/6) will be compared to patients with high levels of progression e.g. (C2 to C4, C2 to C5/6, C3 to C5/6). Patient with high speed CVD progression (progression in less than 5 years) will be compared to those with low speed of progression (progression in more than 5 years).Description: Technical Summary
Manifestations of CVD are classified using Clinical, Aetiology, Anatomic, Pathophysiology (CEAP) stages. This retrospective population-based cohort study aims to:
1. Estimate the overall annual period prevalence of CVD and the prevalence of each CEAP stage, for different geographical regions, over a ten-year period (1st June 2008 Â 31st May 2018)
2. Explore factors associated with the development of CVD across different, age, gender and CEAP stages.
3. Explore factors that contribute to the progression of CVD.
Study population: The overall study population is all adult patients with at least one year prior Up to Standard registration in CPRD within each 12-month period over the 10-year interval.
Codes corresponding to different CVD CEAP stages will be used to define the CVD cohort. An age and gender matched control group, with no prior CVD code, will be randomly selected from the study population. Patients with serial CVD codes over the 10-year period will be used to evaluate CVD progression to different CEAP stages.
Prevalence: A period prevalence will be calculated annually in the 10-year interval for overall CVD prevalence and prevalence at each CEAP stage. Prevalence will be stratified to geographical regions and deprivation levels. Prevalence trends over the 10-year interval will be measured.
CVD and progression risk factor analysis: Four patient cohorts will be defined from the study population: CVD patients, a non-CVD control group, CVD patients with slow/ no progression and CVD patients with high speed progression. Descriptive statistics will be used to describe demographic, lifestyle and clinical characteristics of these different cohorts. Using these patient cohorts, multi-variate regression modelling will be used to evaluate risk factors for the development and progression of CVD. These will be adjusted for age, gender and other confounding factors such as treatment interventions. A marginal structures model will be used to evaluate time dependent covariates.
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Incidence, prevalence, resource use and clinical outcomes of heart failure in England: a linked descriptive analysis of primary and secondary care (PULSE) — Ruth Farmer ...
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Incidence, prevalence, resource use and clinical outcomes of heart failure in England: a linked descriptive analysis of primary and secondary care (PULSE)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-20
Organisations:
Ruth Farmer - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Ruth Farmer - Corresponding Applicant - Boehringer-Ingelheim Pharmaceuticals, Inc
Andrew Ternouth - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Gary Solomons - Collaborator - Boehringer Ingelheim Limited
Nicholas Gollop - Collaborator - Boehringer-Ingelheim - UKOutcomes:
Primary outcomes:
Prevalent heart failure (HF); Incident HF; HF related hospital admission (HHF); HF related primary care consultation; Number of prescriptions issued for HF medications; cardiovascular mortality; all-cause mortality
Secondary outcomes:
Referral source of HF hospital admission; time to first hospitalisation for HF; time to second hospitalisation for HF; time to third hospitalisation for HF, number of GFR/serum creatinine tests in primary care; change in eGFR.
Description: Technical Summary
Heart failure (HF) is associated with high levels of morbidity and mortality. It may present as impaired ventricular systolic or diastolic function, a.k.a. âreducedâ (rEF) and âpreservedâ (pEF) ejection fraction (EF) respectively. Previous epidemiological studies of HF burden in the UK have either not been split by EF subtype or have used samples that may not be representative of the entire HF population. This study aims to
1. Estimate the prevalence and incidence of HF in the UK by subtype.
2. Describe HF patient characteristics by subtype.
3. Describe aspects of the burden of HF by subtype in terms of clinical and health resource outcomes.
We will use linked data from CPRD and Hospital Episode Statistics (HES) to establish a cohort of patients with HF between January 2015 and June 2019. Coding systems for UK primary care allow specification of subtype, and EF may be entered for some patients. By combining these ways to distinguish subtype, we will group HF patients into reduced, preserved and unknown EF.
Using additional data on the overall CPRD population, we will estimate yearly prevalence and incidence of HF by subtype, using 95% confidence intervals to quantify uncertainty. Patient characteristics by subtype will be presented descriptively.
Primary outcomes of interest during the study period (HF cohort only) include hospitalization for heart failure (obtained from linked HES), HF related GP consultations, prescriptions for HF medication, and mortality (obtained via linked office for national statistics data). Recurrent event outcomes will be analysed using negative-binomial models including subtype as a covariate. Cumulative incidence functions will be used to estimate survival and other time to event outcomes overall and by subtype. Potential differences between subtypes will be quantified using the Fine and Grey model to allow for competing risks due to other cause mortality where relevant.
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Using large-scale routine data to monitor and improve ethnic inequalities in cancer and cardiovascular disease — Amitava Banerjee ...
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Using large-scale routine data to monitor and improve ethnic inequalities in cancer and cardiovascular disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-21
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Zareen Thorlu-Bangura - Corresponding Applicant - University College London ( UCL )
Charlotte Manisty - Collaborator - University College London ( UCL )
David Adlam - Collaborator - University of Leicester
Michael Sweeting - Collaborator - University of Leicester
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
The outcomes measured in this study are as follows:
 All-cause mortality
 Cancer mortality
 Cardiovascular mortality
 COVID-19 Mortality
 COVID-19 Hospitalisations
 Healthcare Utilisation (GP visits, clinic appointments, hospital appointments, investigative procedures e.g endoscopy, colposcopy and colonoscopy)
 Completeness of ethnicity dataDescription: Technical Summary
Cancer and cardiovascular disease (CVD) have been identified as leading causes of premature death and morbidity in the UK. Cancer and CVD frequently coexist, e.g. treatment for cancer may be associated with heart disease. This project will focus on the following 12 CVDs: cardiac arrest, abdominal aortic aneurysm, transient ischaemic attack, stable angina, intracerebral haemorrhage, myocardial infarction, Ischaemic stroke, heart failure, unstable angina, unheralded coronary death, peripheral arterial disease and subarachnoid haemorrhage. For cancer we will focus on the following 20 most common cancers: oral cavity, oesophageal, stomach, colorectal, liver, pancreas, lung, malignant melanoma, breast, cervix, uterus, ovaries, prostate, kidney, bladder, central nervous system lymphoma, thyroid, non-Hodgkin lymphoma, multiple myeloma and leukaemia. The project will also look at COVID-19 mortality and hospitalisation rates to determine the proportion of patients with cancer and CVD by ethnic group.
Ethnic inequalities have been identified in both cancer and CVD for access to healthcare services and outcomes. Our objective is to assess whether individuals from black and minority ethnic (BME) backgrounds with coexisting cancer and CVD are less likely to have access to healthcare and worse outcomes. We hypothesise that individuals from BME groups with coexisting cancer and CVD have less access to services and worse outcomes than white individuals.
We aim to use linked national electronic health record data to:
- Investigate the quality of ethnicity reporting in cancer and CVD.
- Characterise incidence, prevalence and outcome of coexisting cancer and CVD in BME groups between 2000 and 2020, compared with white individuals.
- Investigate healthcare utilisation by ethnic group in coexisting cancer and CVDBy highlighting the reporting of ethnicity in healthcare data, and the burden of cancer and CVD in BME groups, we will identify health inequalities and inform targeted future policies for public health improvement within communities at risk of cancer and CVD.
Source -
A comparison of cancer incidence and prevalence in CPRD GOLD and CPRD Aurum primary care databases — Rachael Williams ...
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A comparison of cancer incidence and prevalence in CPRD GOLD and CPRD Aurum primary care databases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-16
Organisations:
Rachael Williams - Chief Investigator - CPRD
Daniel Dedman - Corresponding Applicant - CPRD
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michael Rawlins - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nancy Wexler - Collaborator - Columbia University
Stephen Evans - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Cancer incidence and prevalence for all sites combined (excluding non-melanoma skin cancer [NSMC]), and for 10 most common sites for females and males, (see Table 1).
Table 1: Ten most common cancer sites in females and males in England, 2017*
Females Males
Rank ICD-10 code and site ICD-10 code and site
1 C50 Malignant neoplasm of breast C61 Malignant neoplasm of prostate
2 C34 Malignant neoplasm of bronchus and lung C34 Malignant neoplasm of bronchus and lung
3 C18-C20 Malignant neoplasm of colon and rectum C18-C20 Malignant neoplasm of colon and rectum
4 C54 Malignant neoplasm of corpus uteri C43 Malignant melanoma of skin
5 C43 Malignant melanoma of skin C82-C85 Non-Hodgkin's lymphoma
6 C56 Malignant neoplasm of ovary C67 Malignant neoplasm of bladder
7 C82-C85 Non-Hodgkin's lymphoma C20 Malignant neoplasm of rectum
8 C25 Malignant neoplasm of pancreas C64 Malignant neoplasm of kidney, except renal pelvis
9 C64 Malignant neoplasm of kidney, except renal pelvis C15 Malignant neoplasm of oesophagus
10 C91-C95 Leukaemia C91-C95 Leukaemia
* Based on cancer registrationsDescription: Technical Summary
The Clinical Practice Research Datalink (CPRD) provides two primary care electronic health record (EHR) databases for observational research: CPRD GOLD uses data from the Vision GP software, and CPRD Aurum which uses data from the EMIS Web GP software. Using both databases in a single study can increase statistical power, increase generalisability due to a more representative population, or allow validation of findings in a second independent data source. However it is important to first verify that the databases are comparable, and understand the reasons for any differences.
We will use CPRD GOLD and CPRD Aurum and compare prevalence and incidence of cancer in all sites combined, and in the 10 most common sites for males and females. The main analysis will ascertain incident and prevalent cases using the primary care data only, and compare time trends between 1990-2019 inclusive, and patterns stratified by age, gender, region, and area-based deprivation.
In secondary analyses, comparisons will be repeated in a subset of Âoverlapping practices which intially contributed data to CPRD GOLD, and subsequently contributed data to the CPRD Aurum database. We will also use an interrupted time series (ITS) analysis to formally test whether recording patterns for incident cancers change after practices switch from Vision to EMIS Web GP software. If appropriate, we will use multi-level Poisson models to further assess the relative contributions of measured population characteristics and between database variation.
We will repeat the main analyses using linked HES Admitted Patient Care (APC) and ONS death registration data to ascertain additional cancer outcomes between 2000-2019.
The findings will inform a planned study of the association between HuntingtonÂs disease and cancer risk, but will be of wider value to other researchers wishing to use conduct observational research involving cancer outcomes, and combining CPRD GOLD and CPRD Aurum databases to increase study power.
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Examining primary care interactions, monitoring, prescribing and outcomes pre, during, and post Covid-19 in people with diabetes — Darren Ashcroft ...
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Examining primary care interactions, monitoring, prescribing and outcomes pre, during, and post Covid-19 in people with diabetes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-09-15
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Alison Wright - Corresponding Applicant - University of Manchester
Hood Thabit - Collaborator - Manchester University NHS Foundation Trust (MFT)
Lalantha Leelarathna - Collaborator - Manchester University NHS Foundation Trust (MFT)
Martin Rutter - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Naresh Kanumilli - Collaborator - NHS England
Nicola Milne - Collaborator - Manchester University NHS Foundation Trust (MFT)Outcomes:
Comparison of pre-, current, and post-Covid-19 time periods:
Phase 1: Primary care-related
? Frequency of consultations and mode of consultation (face-to-face, telephone, video call)
? Incidence of diabetes
? Frequency of referrals to secondary care
? Frequency of referrals to diabetes services
? Diabetes care processes; measurement of glycated haemoglobin (HbA1c), blood pressure (BP) and cholesterol levels, retinal screening, foot checks, urinary albumin and serum creatinine testing, weight check, smoking status check
? Prescriptions for the management of diabetes and cardiovascular risk factors
? Diagnoses of alcohol abuse
? Diagnoses of mental health disorders including; depression, anxiety and self-harm
? Diabetes-related complications including; diabetic foot ulcers, amputations, microvascular complications (retinopathy, neuropathy, nephropathy)
? Cardiovascular events including; myocardial infarction, stroke, heart failure, and revascularisation procedures
? Thromboembolic disease (pulmonary embolism, deep vein thrombosis) and prescriptions for anticoagulation drugs
? Interstitial lung disease and pulmonary fibrosis
? Brain natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) levels
? Death ratePhase 2: Linked data, ONS and hospital-related
? All-cause mortality
? Cause-specific mortality
? Hospitalisation
? ICU admission
? Acute kidney injury
? Renal replacement therapy including; dialysis (haemodialysis, peritoneal dialysis) and transplantation
? Diabetes-related complications including; diabetic foot ulcers, amputations, microvascular complications (retinopathy, neuropathy, nephropathy)
? Cardiovascular events including; myocardial infarction, stroke, heart failure, acute cardiac injury and revascularisation procedures
? Thromboembolic disease (pulmonary embolism, deep vein thrombosis)
? Interstitial lung disease and pulmonary fibrosisDescription: Technical Summary
In this descriptive study we will explore the impact of Covid-19 in people with diabetes by comparing primary and secondary care interactions and outcomes in pre- (Jan 2010-Feb 2020), current (Mar 2020 [full UK lockdown] to post Covid-19), and post-Covid-19 (future date when 70% of the population have been successfully vaccinated) time periods.
In Phase 1 we will use primary care records (CPRD GOLD/Aurum) from 01/01/2010 until the latest available date in the most recent CPRD release for patients with >1 year of continuous registration prior to cohort entry.
In each calendar month we aim to estimate incidence and prevalence rates of consultations, referrals, diabetes care processes, prescriptions, alcohol abuse, diagnoses [diabetes, diabetes-related and cardiovascular complications, thromboembolic disease, lung disease, mental health disorders], and death. Person-time will be calculated from the total number of individuals at risk in each calendar month.For Phase 2, patients identified in Phase 1 will be linked to patient- and practice-level IMD, HES APC, HES A&E, HES Outpatient and ONS death registration to estimate incidence, prevalence and mortality rates in secondary care. Within pre-Covid, current and post-Covid periods, we aim to compare rates of cause-specific mortality, hospitalisations, ICU admissions, kidney disease and renal replacement therapy, diabetes-related complications, cardiovascular events, thromboembolic disease and lung disease.
We aim to use negative binomial regression to model 10 years of pre-Covid rates to define expected rates. Forecasting predictions will determine differences between observed and expected rates. Rates will be stratified by age, gender, type 1 and type 2 diabetes, ethnicity, deprivation, UK regions, history of cardiovascular disease, kidney disease, clinical risk (defined by levels of pre-Covid risk factors including HbA1c, blood pressure and lipid levels) and Freestyle Libre use to help identify if particular groups of people may have been more severely affected.
Source
2020 - 08
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Homelessness Data England: Linking local authority data to evaluate homelessness policy — unknown...
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Homelessness Data England: Linking local authority data to evaluate homelessness policy
Where: unstated
When: 2020-8-10
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
In collaboration with the Office for National Statistics (ONS) and the Department for Levelling Up, Housing & Communities (DLUHC), this project aims to create a linked dataset of information about homelessness in England, to improve our understanding of its causes and impacts.
This will allow decision makers to develop more effective policies to reduce homelessness and improve the lives of people across the country. Specifically, the Homelessness Data England project will involve linking Homelessness Case Level Information Collection (H-CLIC) data from across local authorities in England, and to other administrative datasets. H-CLIC data records local authoritiesâ actions under the 2017 Homelessness Reduction Act, which significantly reformed Englandâs homelessness legislation by placing duties on local authorities to intervene at earlier stages to prevent and reduce homelessness.
The projectThe project has three elements, some of which will be phased:
The first aims to use the linked H-CLIC data from across local authorities to develop a better understanding of whether homelessness is resolved in the long-term, particularly across local authority boundaries. This will help to establish what works to prevent homelessness, and which elements of the Homelessness Reduction Act are most effective. The second aims to match together H-CLIC data and the Rough Sleeping Evaluation Questionnaire to identify how effectively interventions have prevented homelessness and improved other outcomes in the longer term. DLUHC already have rough sleeping evaluations in progress that would benefit from this work. Finally, the third element aims to match the H-CLIC data to data gathered from other government departments/health agencies to determine the wider circumstances and outcomes of people who have experienced homelessness, such as educational outcomes, employment, benefits and health. This will enable us to identify the wider impacts and longer-term outcomes, and estimate the costs of homelessness. What is the potential of this newly linked data?DLUHC intends to use the data to assess the implementation of the Homelessness Reduction Act, for example by identifying the factors associated with better or worse outcomes for households at risk of homelessness and to understand more about the factors that drive homelessness and how best to address them.
Ultimately, the project will provide central government departments, local public services and delivery partners with valuable information about the cycle of homelessness and its impact on the lives of those it affects, as well as the impact and cost-benefit of interventions and services targeted at reducing homelessness. The information should be useful to inform future service design and reform and investment decisions.
A deidentified version of the homelessness linked dataset will be made available to accredited researchers for approved projects that are in the public good through the ONS Secure Research Service in due course. Keep an eye on this page for further information.
Project details Project lead: Lan-Ho Man, DLUHC Duration: October 2019 onwardsIf you work for a local authority and have any enquiries about this project, please contact DLUHC here.
This project is funded by ONS via its core grant from the Economic & Social Research Council (ESRC) as an ADR UK partner.
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Demographic (Identifiable) (Direct Care) — NHS England ...
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The purpose of the dissemination is to support the national call/recall of free flu cohorts. This is described in the annual letter to the NHS: âNHSEI are developing a national call and recall service to support localised call and recall provision and ensure that all eligible patients are informed of their eligibility and are encouraged to get vaccination this season. This service is intended to supplement not replace local call and recall mechanisms that are already in place contractually.â NHS Digital will: ⢠Generate free flu vaccine cohorts ⢠Collate flu vaccine results The dissemination is required to ensure that individuals are informed and uptake free flu vaccines, thereby protected themselves and (through herd immunity) the population. This is especially important this year due to the COVID-19 pandemic, the health risk posed by flu and COVID-19 and the need to protect the NHS. — IG-00978_1
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 24/08/2020
Purpose for which the data is being used: The purpose of the dissemination is to support the national call/recall of free flu cohorts. This is described in the annual letter to the NHS: âNHSEI are developing a national call and recall service to support localised call and recall provision and ensure that all eligible patients are informed of their eligibility and are encouraged to get vaccination this season. This service is intended to supplement not replace local call and recall mechanisms that are already in place contractually.â NHS Digital will: ⢠Generate free flu vaccine cohorts ⢠Collate flu vaccine results The dissemination is required to ensure that individuals are informed and uptake free flu vaccines, thereby protected themselves and (through herd immunity) the population. This is especially important this year due to the COVID-19 pandemic, the health risk posed by flu and COVID-19 and the need to protect the NHS.
Dataset: Demographic
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Covid-19 Testing Results (Identifiable) (Secondary Uses) — Department of Health and Social Care...
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For analysis of Covid-19 test results for reporting purposes both within DHSC and NHSD, and production of official statistics that are published by the Department of Health on a daily basis. — IG-00981
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 10/08/2020
Purpose for which the data is being used: For analysis of Covid-19 test results for reporting purposes both within DHSC and NHSD, and production of official statistics that are published by the Department of Health on a daily basis.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: COPI Regulation 3(3)(c)
Common Law Duty of Confidentiality: COPI Regulation 3(3)(c)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Demographic (Identifiable) (Direct Care) — NHS England ...
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NHS England has commissioned NHS South West and Central CSU (which is part of NHS England) to implement a National Immunisation Management Service (NIMS). The implementation of this service will deliver a centralised service for the management of seasonal flu immunisation and is an essential component of NHS Englandâs response to the COVID-19 pandemic. This is because 1.it will help to ensure that any second âspikeâ in coronavirus infections in England separated in time as far as possible from the annual flu epidemic â so minimising pressures on NHS resources 2.it will provide a protype for the delivery of a subsequent national COVID-19 immunisation programme by establishing a dynamic infrastructure capable of responding rapidly to target appropriate cohorts across the whole population of England. It is essential that the two programmes are coordinated to accommodate the developing characteristics of the pandemic, and any interfaces between the vaccines, and their delivery processes as they are established. The purpose of the dissemination is to support the following: 1.national call/recall for influenza; and 2.national call/recall for COVID-19 vaccination. NHS England has confirmed that details of all patients registered with practices in England is required in support of this service. — IG-00978_2
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 27/08/2020
Purpose for which the data is being used: NHS England has commissioned NHS South West and Central CSU (which is part of NHS England) to implement a National Immunisation Management Service (NIMS). The implementation of this service will deliver a centralised service for the management of seasonal flu immunisation and is an essential component of NHS Englandâs response to the COVID-19 pandemic. This is because 1.it will help to ensure that any second âspikeâ in coronavirus infections in England separated in time as far as possible from the annual flu epidemic â so minimising pressures on NHS resources 2.it will provide a protype for the delivery of a subsequent national COVID-19 immunisation programme by establishing a dynamic infrastructure capable of responding rapidly to target appropriate cohorts across the whole population of England. It is essential that the two programmes are coordinated to accommodate the developing characteristics of the pandemic, and any interfaces between the vaccines, and their delivery processes as they are established. The purpose of the dissemination is to support the following: 1.national call/recall for influenza; and 2.national call/recall for COVID-19 vaccination. NHS England has confirmed that details of all patients registered with practices in England is required in support of this service.
Dataset: Demographic
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Shielded Patient List (SPL) (Identifiable) (Direct Care) — NHS Mental Health Providers...
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In order to be able to proactively contact and support patients under their care, Mental Health, Learning Disability and Autism teams need to be able access their local Shielded Patient Lists so they can cross-check these lists by NHS number against their clinical systems in order to identify those patients under their care who are shielding. — IG-00492_2
Recipient Data Controller Organisation(s) : NHS Mental Health Providers
Approval Date: 17/08/2020
Purpose for which the data is being used: In order to be able to proactively contact and support patients under their care, Mental Health, Learning Disability and Autism teams need to be able access their local Shielded Patient Lists so they can cross-check these lists by NHS number against their clinical systems in order to identify those patients under their care who are shielding.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal Obligation GDPR Article 6(1)(d) â Vital Interests GDPR Article 6(1)(d) â Public Task GDPR Article 9(2)(h) â Healthcare Purposes, plus Part 1 Schedule 1 DPA 2018, para 2 - health or social care purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
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Defining clinical research phenotypes using SNOMED CT — Anoop Shah ...
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Defining clinical research phenotypes using SNOMED CT
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-19
Organisations:
Anoop Shah - Chief Investigator - University College London ( UCL )
Anoop Shah - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Musaab Eltaib Elkheder - Collaborator - University College London ( UCL )
Nanaki Maitra - Collaborator - University College London ( UCL )
Rini Veeravalli - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Comparison of phenotype definitions (sets of SNOMED CT terms) derived using different methods. When used to identify a patient cohort, we will compare the cohorts in terms of the number of patients, age at diagnosis, sex distribution, medications, laboratory results and comorbidities.
Description: Technical Summary
Research studies using electronic health record databases need to identify patients with particular diagnoses using definitions based on coded entries (such as Read codes or ICD-10 codes). The lists of codes that define a diagnosis of interest have typically been defined using keyword searching (Read) or by traversing a hierarchy (ICD-10). However, diagnoses are increasingly encoded using SNOMED CT, which incorporates an ontology which encodes relationships between terms. In principle, the ontology could be used to create a set of terms for a concept based on a single term or SNOMED CT expression, but this has not previously been tested against other methods of creating sets of SNOMED CT terms of interest.
In this study we will develop a method to interpret SNOMED CT expressions and compare the resulting set of SNOMED CT concepts with those derived from keyword searching on the SNOMED CT descriptions, or from previously published phenotype definitions on the CALIBER portal (https://caliberresearch.org/portal/codelists) (mapped from Read V2 to SNOMED CT using the NHS mappings). We will compare the SNOMED CT terms selected by the two methods and use them to generate cohorts of patients from a random sample of CPRD Aurum. We will compare the number of patients, date of diagnosis, age distribution and sex distribution using the two methods. We will initially study a number of common disease examples with existing published phenotype definitions such as diabetes, asthma and heart failure, and then expand to other phenotypes used for CALIBER studies (e.g. https://github.com/spiros/chronological-map-phenotypes).
We will publish the methods and code used to interpret SNOMED CT expressions, and if our approach is successful it could be used in future research projects to assist in phenotype definition. This could make future research studies quicker and more reproducible, leading to patient benefit from higher quality research.
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Development and validation of a risk stratification tool for patients with acute myocardial infarction (AMI) in UK primary care — Salwa Zghebi ...
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Development and validation of a risk stratification tool for patients with acute myocardial infarction (AMI) in UK primary care
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-27
Organisations:
Salwa Zghebi - Chief Investigator - University of Manchester
Salwa Zghebi - Corresponding Applicant - University of Manchester
Azfar Zaman - Collaborator - Newcastle upon Tyne Hospitals NHS Foundation Trust
Corneliu Arsene - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Mamas Mamas - Collaborator - Keele University
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
The primary outcome will be all-cause mortality. The secondary outcomes will be CV mortality, incident heart failure, stroke and recurrent MI, as well as a composite of the secondary outcomes. We will differentiate between ischaemic and haemorrhagic stroke events. All-cause mortality (primary outcome) will be identified from primary care and ONS data; CV mortality (secondary outcome) from ONS data; and CVD events (heart failure, stroke and recurrent MI) from primary care and HES APC data.
Description: Technical Summary
Background
Cardiovascular (CV) disease (CVD) accounts for 25% of all UK deaths. Several CV risk prediction tools exist for incident (new onset) CVD (e.g. QRISK, Framingham). However, no such tools are available for people with prevalent (existing) CVD despite the clinical need for these tools for risk stratification.Methods
Using electronic records from the UK Clinical Practice Research Datalink (CPRD) GOLD, we will develop a CV risk tool in a prevalent cohort of people with acute myocardial infarction (AMI) between 2006-2014. Cox regression models will be used to estimate 1- and 5-year risk for all-cause mortality (primary outcome), and CV mortality, heart failure, stroke, and recurrent myocardial infarction (MI) (individually and as composite secondary outcomes). We will adjust for covariates' changes (age, CV risk factors, comorbidities) using dynamic models. We will examine the association of the length of the look-back window of the previous AMI event with both outcomes.
Furthermore, we will use supervised Machine Learning (ML) techniques for competing risks analysis (death as a competing event) and single risk analysis (combination of deaths and CVD outcomes). The ML approaches will be Deep Learning models and Random Forests. For the Deep Learning models the data will be randomly divided in a training dataset (80%) and a validation dataset (20%), while for the Random Forests will be used the internal validation based on bootstrap sampling. The ML techniques will be assessed by using the AUROC in the validation dataset. The problems of model overfitting and missing data will be tackled as well.
The tool will be validated using CPRD Aurum database. Patients registered in >1,000 CPRD practices will be used.
This proposed CV risk stratification tool will help primary care providers find patients with CVD who are at higher risk from future adverse events that may benefit from more targeted interventions.
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Excess mortality during the COVID-19 pandemic — Krishnan Bhaskaran ...
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Excess mortality during the COVID-19 pandemic
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Carstairs Index for 2011 Census (Excluding Northern Ireland)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-04
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Bianca De Stavola - Collaborator - University College London ( UCL )
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
David Leon - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
All-cause mortality
Description: Technical Summary
In recognition of limitations of cause-specific death data, estimates of excess mortality are routinely used to estimate and compare deaths due to seasonal influenza epidemics. These are based on national death registration data which allows for stratification by age, sex and geographic region. We aim to replicate these analyses for the COVID-19 pandemic in the UK with further stratification by COVID-19 effect modifiers that can be measured in primary care data.
Time series methods will be used in our primary analyses of observed mortality during the whole period (pre-COVID-19 and during COVID-19) using generalised linear models with a negative binomial error structure. The main outcome is mortality, measured in primary care data using the CPRD derived death date and the main exposure is the pandemic period (1st March 2020 onwards). The model will initially include exposure, age, sex, and terms to capture seasonality and underlying year-on-year trends. Interaction terms will be used to investigate excess mortality during the pandemic according to demographic, lifestyle-related and comorbidity characteristics. Relative and absolute differences in excess mortality will be described.
We will compare our primary time series approach to national excess mortality estimates. In a secondary analysis to check conclusions, we will compare weekly mortality with expected mortality based on comparable week-of-year mortality in the years prior to the pandemic (standardised mortality ratio (SMR) approach). We will also explore an approach based on individual-level cohort data, with the pandemic period included as a time-updated variable. In secondary analyses we will use updated linked ONS mortality data when available to repeat the analysis using the ONS death date and HES APC data to improve ascertainment of comorbidities.
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To investigate trends in the occurrence of severe, food-induced allergic reactions — Jennifer Quint ...
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To investigate trends in the occurrence of severe, food-induced allergic reactions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-17
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Constantinos Kallis - Corresponding Applicant - Imperial College London
Paul Turner - Collaborator - Imperial College London
Sadia Haider - Collaborator - Imperial College LondonOutcomes:
- Prevalence and Incidence of Food Hypersensitivity (FHS) (and its various subtypes) in the last 10 years in the UK
- Within patients with FHS, the number of healthcare encounters due to food hypersensitivity over the past 10 years presenting to primary versus secondary care in England and how this has changed year on year
- Number of encounters for near-fatal food allergy (as measured by HDU and/or ICU admission) and death from anaphylaxis (in-hospital death)
- Cost of healthcare encountersDescription: Technical Summary
This work will address a key question: what are the trends in the occurrence of food hypersensitivity reactions, including consequential health encounters (both hospital and primary care), using existing NHS datasets.
Specifically, we will:
i. Attempt to establish the accuracy/validate the different codes used in primary and secondary care for food hypersensitivity, to guide future use of NHS datasets to monitor trends in epidemiology.
ii. Assess linked Primary and Secondary care records from CPRD (with respect to NHS encounters: primary care; Accident & Emergency visits; hospital admissions) due to food hypersensitivity over the past 10 years, in order to assess the trends in food hypersensitivity reactions in England (and where data can be accessed, for the devolved nations).
iii. Investigate patient pathways with respect to health encounters
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Is chronic obstructive pulmonary disease, diabetes, and life-style variables reco(r)ded similarly in CPRD GOLD and Aurum? — Estel Plana Hortoneda ...
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Is chronic obstructive pulmonary disease, diabetes, and life-style variables reco(r)ded similarly in CPRD GOLD and Aurum?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-20
Organisations:
Estel Plana Hortoneda - Chief Investigator - RTI Health Solutions
Estel Plana Hortoneda - Corresponding Applicant - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Collaborator - RTI Health Solutions
David Martinez - Collaborator - RTI Health Solutions
Jaume Aguado - Collaborator - RTI Health Solutions
Ryan Ziemiecki - Collaborator - RTI Health SolutionsOutcomes:
COPD and diabetes will be defined using READ codes and SNOMED codes in GOLD and Aurum, respectively, using data any time before date of migration from Vision to EMIS (migration date), and in Aurum both 1 year before the migration date and 1 year after the first collection date.
Three life-style variables will be evaluated:
- BMI within 3 years prior and closest to the migration date will be reported in categories: Underweight, Normal, Overweight, Obese, Missing. In GOLD, BMI (kg/m2) as a value will be derived from entity types for BMI, height, and weight. In Aurum, values corresponding to BMI, height or weight codes will be used to derive the BMI value. Once calculated, the BMI value will be categorized as <20 (Underweight), 20-25 (Normal), 25-30 (Overweight), and >30 (Obese). Both in GOLD and Aurum, clinical codes will be used to build the variable BMI in categories.
- Smoking status within 10 years prior and closest to the migration date will be reported in categories: Never smoker, former smoker, current smoker, and missing. In GOLD, entity types will be used to define the patientÂs smoking status. Both in GOLD and Aurum, clinical codes will be used to build this variable.
- Alcohol consumption within 10 years prior and closest to the migration date will be reported in categories: Never drinker, former drinker, current drinker (divided in low or moderate (? 6 units/day), heavy (? 7 units/day), or unknown amount consumption), and missing. For current drinkers, amount of alcohol consumption will be derived from entity type in GOLD and values and units associated with alcohol codes in Aurum. Both in GOLD and Aurum, clinical codes will be used to categorize this variable.
- Number of hospitalizations or emergency department visits recorded in both GOLD and AurumDescription: Technical Summary
In England, many primary care practices migrated from VISION to EMIS software. In 2017, Clinical Practice Research Datalink (CPRD) launched Aurum, incorporating some of these migrating practices from GOLD and new practices using EMIS. Studies using Aurum data are ongoing and code lists as well as algorithms to define variables in the studies are adapted from the GOLD experience.
Our objectives are to evaluate:
- Data migration of historical data from GOLD to Aurum by assessing:
o The prevalence of chronic obstructive pulmonary disease (COPD) diagnosis, medications, and distribution of FEV1 predicted.
o The prevalence of Diabetes diagnosis, medications, and distribution of Hba1c.
o The distribution of BMI, smoking status, and alcohol consumption.
o Number of hospitalizations or emergency department visits
- New recording of COPD data in Aurum by comparing data within 1 year before the migration date and 1 year after the first collection date on:
o The prevalence of chronic obstructive pulmonary disease (COPD) diagnosis, medications, and distribution of FEV1 predicted.
o The prevalence of Diabetes diagnosis, medications, and distribution of Hba1c.
Source - and 11 more projects — click to show
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An assessment of patient characteristics and treatment patterns among ASCVD patients with hypercholesterolemia, ASCVD-risk equivalent patients with hypercholesterolemia and FH patients — Christopher Morgan ...
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An assessment of patient characteristics and treatment patterns among ASCVD patients with hypercholesterolemia, ASCVD-risk equivalent patients with hypercholesterolemia and FH patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-27
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Raquel Lahoz - Collaborator - NOVARTISOutcomes:
Patient demographics; cardiovascular comorbidities; baseline cholesterol-lowering therapy, baseline biochemistry, therapy change, LDL-C change.
Description: Technical Summary
Low density lipoprotein cholesterol (LDL-C) has been strongly associated with cardiovascular disease (CVD) and coronary heart disease (CHD) risk. It has been demonstrated that reducing LDL-C may halt the progression of atherosclerotic plaque and thus reduce the incidence of atherosclerotic cardiovascular disease (ASCVD). Inclisiran is a long-acting, subcutaneously delivered, synthetic siRNA directed against PCSK9 messenger RNA that is conjugated to triantennary GalNAc carbohydrates for targeted delivery to the liver. The ORION randomized clinical trials demonstrated increased efficacy of inclisiran versus placebo in reducing LDL-C. In this retrospective, descriptive study we aim to use the Clinical Practice Research Datalink to conduct a retrospective, descriptive study of the patient groups eligible for the Orion. Three non-mutually exclusive patient cohorts with i) ASCVD, ii) ASCVD-risk equivalent (based on presence of Type 2 diabetes, familial hypercholesterolemia or a baseline Framingham risk score indicative of 20% chance of 10 year cardiovascular event), iii) familial hypercholesterolemia will be extracted. From these study sets those with evidence of hypercholesterolemia based on either clinical diagnosis, LDL-C test results or prescription of lipid-lower therapy will form the three study cohorts. The primary objective is to describe the demographics, clinical characteristics, baseline biochemistry and baseline lipid lowering regimens of these cohorts. Secondary objectives are to assess initial cholesterol-lowering treatment patterns in terms of dose changes, switching, adding discontinuation and re-initiation and to understand how treatment patterns relate to changes in LDL-C levels over time. Linked data from the Hospital Episode Statistics admitted patient care dataset will also be used to ascertain both exposures and descriptive disease and surgical procedure outcomes.
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Improving the definition of recurrent UTI and understanding patient factors associated with greater frequency of recurrence — Gail Hayward ...
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Improving the definition of recurrent UTI and understanding patient factors associated with greater frequency of recurrence
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-27
Organisations:
Gail Hayward - Chief Investigator - University of Oxford
Maria Vazquez Montes - Corresponding Applicant - University of Oxford
Christopher Butler - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Harry Ahmed - Collaborator - Cardiff University
Sarah Lay-Flurrie - Collaborator - University of Oxford
Thomas Fanshawe - Collaborator - University of OxfordOutcomes:
The outcome is UTI episodes, defined as contacts with a UTI related symptom or a UTI-specific antibiotic code list: Contacts within 28 days of an index contact will be assumed to be related to the index infection, in line with previous studies (38), although a sensitivity analysis will explore contacts within 14 days as a less restrictive definition.
Description: Technical Summary
Recurrent Urinary Tract Infections (RUTIs), currently defined as ?2 UTIs in 6 months or 3 in a year, affect ~800000 women in the UK annually, causing pain, fever and urinary frequency. Many women are prescribed antibiotics for RUTI, which cause side-effects and drive antibiotic resistance. GPs find managing this condition challenging, because there is insufficient evidence indicating which women will benefit from preventative treatment.
Aim
To characterise women at greatest risk of RUTI and women to whom GPs should consider offering prophylactic treatmentObjectives:
1. Describe the burden of women with UTI contacting UK primary care
2. Develop a new definition of RUTI based on the frequency of clinical recurrence
In women with RUTI:
3. Describe the demographic (age, socioeconomic group) and clinical features (comorbidities, patterns of presentation, duration of antibiotics) associated with increased risk of subsequent UTI
4. In those receiving prophylactic antibiotics, explore features associated with successful prophylaxis (i.e. 25% or 50% reduction, no medically attended infections/hospital admissions with UTI, no pyelonephritis/sepsis during prophylaxis)
5. Explore patient and disease factors associated with UTI-related hospital attendanceMethods
Data will be women aged 16+ with ?1 UTI episode. GP contacts within 28 days of one another will be considered as the same episode. Proportion of UTI-related consultations will be calculated for all UTIs and for RUTIs. Cox regression will be used to investigate 1) patterns of RUTI, censoring at exit from a participating practice, end of study, or death (if >5%, competing risks methods will be investigated); 2) factors associated with RUTI risk, including number of previous UTIs, time since last UTI, and prophylaxis; 3) factors associated with success of prophylaxis for RUTI; and 4) patient/disease characteristics associated with complications, linking with HES Admitted Patient Care and Accident and Emergency databases to determine UTI-related hospital attendance.
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Multimorbidity and pregnancy: epidemiology, clusters, prescriptions, and preterm birth — Krishnarajah Nirantharakumar ...
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Multimorbidity and pregnancy: epidemiology, clusters, prescriptions, and preterm birth
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-20
Organisations:
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Siang Ing Lee - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Astha Anand - Collaborator - University of Birmingham
Charles Gadd - Collaborator - University of Birmingham
Holly Hope - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Siang Ing Lee - Collaborator - University of Birmingham
Tom Taverner - Collaborator - University of BirminghamOutcomes:
(1) Proportion of pregnancies affected by defined morbidities, multimorbidity and multimorbidity clusters
(2) Multimorbidity clusters of pregnant women
(3) Proportion of pregnancies with records of prescriptions at different timepoints of the pregnancy
(4) Odds of pregnancies with pre-existing multimorbidity resulting in pregnancy complications, post-partum complications or long-term adverse health outcomes for mother/child as follow:
i. preterm birth
ii. Mortality & pregnancy loss:
- maternal mortality (death up to 6 weeks, and 1 year, after childbirth or end of pregnancy);
- neonatal mortality (death within 28 days of birth);
- stillbirth / late fetal loss (baby born without signs of life);
- miscarriage
iii. Metabolic complications:
- gestational diabetes
- hypertensive disorder of pregnancy: gestational hypertension, pre-eclampsia, eclampsia, HELLP syndrome
iv. neurodevelopmental disorder of the offspring
v. postnatal depression, puerperal psychosisThese outcomes have been identified to be important by our women representatives and specialists in maternal medicine, obstetrics and perinatal mental health in the study team. These outcomes were also amongst those that have been listed as core outcome measures in pregnancy and maternity care 11 13. Although current literature supports the association with these outcomes when single chronic conditions are present for the pregnant women, we are less clear of their association with multimorbidity;6 21-23 we anticipate the effect size to be higher. The latest UK national maternal mortality review, MBBRACE, has noted that 90% of maternal death within a year occurred in women with multiple health / social problems 15.
Quantifying outcomes associated with pregnancy affected by multimorbidity will provide information to help pregnant women with multimorbidity and clinicians make informed decisions in pregnancy planning, as well as add weight to calls to tailor the maternity care pathway for pregnant women with multimorbidity.
Description: Technical Summary
The aim of the study is to understand how multimorbidity affects pregnancy. We will describe the epidemiology of pre-existing multimorbidity in pregnancy, multimorbidity clusters, prescription pattern in pregnancy, investigate the association of multimorbidity with preterm birth and validate the recording of maternal morbidities and pregnancy complications in primary and secondary care database.
This will be a retrospective cohort study of women with recorded pregnancies between 2000 to 2020 in the CPRD Pregnancy Register. The exposure will be multimorbidity. A list of >90 exposure morbidities were determined through the literature and through a stakeholder workshop. Example disease categories include cardiovascular disease (hypertension, atrial fibrillation, etc), cancer, mental health condition (anxiety, depression, etc), respiratory disease (asthma, pulmonary fibrosis, etc), gastrointestinal disease (inflammatory bowel disease etc) and endocrine disease (diabetes mellitus etc). The outcome will be preterm birth.
The proportion of pregnancies affected by this predefined list of morbidities will be estimated. Determinants of multimorbidity status and clusters will be investigated through subgroup descriptive analysis. Latent class analysis (LCA) and Multiple Correspondence Analysis (MCA) will be performed to examine morbidity clusters in pregnancies.
Descriptive analysis will also be performed for prescription records for drugs catalogued by BNF chapters. This will be stratified by the different time point in the pregnancy. The association of multimorbidity with preterm birth will be investigated using multivariable logistic regression. Generalised Estimating Equations will be used to account for clustering where a woman has more than one pregnancy.
Validation of maternal morbidities and pregnancy complications recording in primary (CPRD) and secondary care database (HES) will be conducted using capture and recapture methods and comparison with previous literature. Pregnancy complications to be studied will be prioritised with stakeholders, examples will include still birth, preterm birth, pre-eclampsia and post-partum haemorrhage.
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The value of additional risk factors in addition to current prediction rules to better predict 10-year cardiovascular risk — Olaf Klungel ...
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The value of additional risk factors in addition to current prediction rules to better predict 10-year cardiovascular risk
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-23
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Frank Visseren - Collaborator - Utrecht University
Jannick Dorresteijn - Collaborator - University Medical Centre Utrecht
Romin Pajouheshnia - Collaborator - Utrecht University
Steven Hageman - Collaborator - Utrecht UniversityOutcomes:
fatal and non-fatal stroke; fatal and non-fatal myocardial infarction; vascular death; all-cause mortality
Description: Technical Summary
The use of prediction models for estimating cardiovascular risk is recommended by European and American guidelines and can help to tailor preventive treatment to the individual patient. Several prediction models are available in the primary prevention to 10-year cardiovascular risk, e.g. the SCORE-model and the ASCVD pooled cohort equation. These models are widely-used and practical because they use easy to measure and generally available risk factors to calculate 10-year cardiovascular risk. In clinical practice however, often other risk factors are known apart from those in the prediction model, for example family history or a coronary calcium score. It is unclear how this additional data affects risk prediction or how best to handle this in clinical practice. The goal of the current study is to validate a methodology of flexible prediction, the naïve method. This method allows extra predictors to be used without the need of a new regression model for every combination of predictor availability. Using this methodology, the effect of the most common additional predictors on top of a basic model will be quantified. Results of the study will be directly implemented in online risk calculators such as www.u-prevent.com for easy clinical use.
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Epidemiology, treatment patterns and healthcare resource use associated with prurigo nodularis in the UK: a retrospective analysis using the Clinical Practice Research Datalink — Christopher Morgan ...
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Epidemiology, treatment patterns and healthcare resource use associated with prurigo nodularis in the UK: a retrospective analysis using the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-05
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence; incidence; baseline characteristics; treatment pathways; health resource utilisation; comorbidity; survival
Description: Technical Summary
This study aims to describe the prevalence and incidence of prurigo nodularis and treatment and resource utilisation associated with the condition from an England perspective. The study will comprise both cross-sectional and longitudinal designs and include non-exposed control subjects. Patients with prurigo nodularis of acceptable research quality and eligible for HES linkage will be selected by medcode or ICD-10 code in the CPRD AURUM (Clinical and Referral tables) and HES admitted patient care table respectively. For the cross-sectional analysis, period prevalence will be calculated for 2018 with index date set as 1st January 2018 or first diagnosis date for those cases diagnosed during 2018. Age, gender and current treatment will be described at index date. For the longitudinal analysis the incidence of prurigo nodularis will be described from 2008-18. Index date will be set as date of first diagnosis. Demographic characteristics, baseline comorbidity and baseline medications at index date will be summarised. Time from index date to first therapy for prurigo nodularis will be reported. First line, second line and third line therapies following index date for the prurigo nodularis exposed cohort will be described by class and whether mono- or combination therapy. Time between each line of therapy will be shown in Kaplan-Meier curves and summary statistics. Controls will be selected by primary care practice, age, gender and current practice registration. Inpatient, outpatient and A&E department contacts will be aggregated and compared between cases and controls. Rates will be compared with controls using Poisson Regression and costs will be compared using the negative binomial distribution. Crude mortality rates and Kaplan-Meier curves will be presented for prurigo nodularis exposed and non-exposed cohorts and mortality compared using a Cox Proportional Hazards model.
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Understanding the health of transgender people: A population-based cross-sectional and linked cohort study — Srinivasa Vittal Katikireddi ...
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Understanding the health of transgender people: A population-based cross-sectional and linked cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-25
Organisations:
Srinivasa Vittal Katikireddi - Chief Investigator - University of Glasgow
Srinivasa Vittal Katikireddi - Corresponding Applicant - University of Glasgow
Bhautesh Jani - Collaborator - University of Glasgow
Christian Delles - Collaborator - University of Glasgow
Claire Niedzwiedz - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
David Blane - Collaborator - University of Glasgow
Desmond Campbell - Collaborator - University of Glasgow
Frederick Ho - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Kirsten Hainey - Collaborator - University of Glasgow
Kirsten Mitchell - Collaborator - University of Glasgow
Naveed Sattar - Collaborator - University of Glasgow
Paul Connelly - Collaborator - University of Glasgow
Paul Welsh - Collaborator - University of Glasgow
Rachel Thomson - Collaborator - University of Glasgow
Robert Aldridge - Collaborator - University College London ( UCL )Outcomes:
We have chosen outcomes to that are of high interest to researchers, health policy makers as well as transgender people who we have consulted about our study plans.
Prevalence outcomes
Common risk factors for non-communicable diseases:
 Alcohol consumption
 Smoking
 Body mass index
 Hypertension
 Diabetes
 Chronic Kidney Disease
 Rheumatoid Arthritis
 DyslipidaemiaMental health outcomes:
 Depression
 Anxiety
 Common mood disorder (depression or anxiety)
 Autistic spectrum disorder
 Schizophrenia and bipolar disorderIncident outcomes
 Cardiovascular disease
 Stroke
 Thromboembolic events
 All cancers (excluding non-malignant skin cancers)
 Gallbladder diseaseMortality outcomes
All-cause mortality
Cause-specific mortalityDescription: Technical Summary
Transgender people experience gender dysphoria due to incongruence between their gender identity and the sex they were assigned at birth. Gender-affirming hormone therapy (testosterone, oestrogen, GnRH analogues and anti-androgens) aim to align the characteristics of transgender people with their gender identity, however, our appreciation of the effects of such treatments on health outcomes is limited.
Research relating to the prevalence of transgender individuals, the risk factors for non-communicable diseases, morbidity (for mental and physical health conditions) and mortality outcomes in transgender people compared to cisgender people is limited by the absence of large cohort studies; lack of appropriate control populations and inadequate data acquisition from gender identity services.
We will use CPRD Gold and Aurum data to define a cohort of transgender individuals between the ages of 16-74 between the study dates of 1 January 1997 and 31st March 2020. We will perform analyses on all transgender individuals and age-sex-GP practice matched cisgender individuals (20 cisgender male and 20 cisgender female controls per transgender individual). Our aims will be to develop, validate and describe a transgender phenotype in the UK, and to profile common risk factors for non-communicable diseases, the incidence of common mental and physical health conditions (cardiovascular disease, stroke, cancer and gallbladder disease), and assess mortality outcomes compared to cisgender people.
We will calculate prevalence risk ratios for each of the risk factors of interest utilising logistic regression and estimation of average marginal effects. One year and lifetime period prevalence will be calculated for common (e.g. depression, anxiety) and rarer (e.g. schizophrenia, bipolar disorder, autistic spectrum disorder) mental health conditions respectively. Cox proportional hazard modelling for the incident common non-communicable diseases, mental health conditions, and disease-specific mortality will be undertaken, adjusting for age, ethnicity and deprivation. Age-standardised mortality rates will also be calculated.
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Healthcare Resource Use, Baseline Characteristics, Clinical Outcomes and Survival Among Patients Undergoing SAVR vs TAVR in England — Jay Were ...
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Healthcare Resource Use, Baseline Characteristics, Clinical Outcomes and Survival Among Patients Undergoing SAVR vs TAVR in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-12
Organisations:
Jay Were - Chief Investigator - Health iQ
Jay Were - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Christopher Spencer - Collaborator - Health iQ
Eva Maria Fuchs - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Yasir Hassan - Collaborator - Health iQOutcomes:
Prevalence of TAVR; Prevalence of SAVR; Prevalence of co-morbidities and risk factors in the cohort (CAD, CABG, PCI, MI, Heart failure, Arrhythmia and AFIB); Demographics (Mean and median age on inclusion, percent males, total, mean and median follow-up and geographical region); Complications post-surgery(Major bleed, acute kidney disease, Coronary-artery obstruction, Major vascular complications, cardiac perforation, stroke, cardiogenic perforations, cardiogenic shock, atrial fibrillation); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality, Major Adverse Cardiac Event, heart failure)
Description: Technical Summary
Aortic stenosis (AS) causes impaired outflow of blood from the heart. The increased cardiac workload leads to left ventricular hypertrophy and heart failure.
Surgical aortic valve replacement (SAVR) with an artificial prosthesis is the conventional treatment for patients with severe AS. Transcatheter aortic valve implantation (TAVI) is a less invasive alternative treatment to SAVR for treating aortic stenosis, avoiding the need for sternotomy and cardiopulmonary bypass.
The Specialised Cardiac Improvement Programme (SCIP) states that due to the initial procedure, the TAVI procedure costs the NHS around double that of the SAVR procedure. However recent evidence suggests that TAVI procedures may be cost saving in the long term due to lower healthcare resource utilisation including cardiac rehabilitation, re-admissions, length of stay and primary care activity.
This will be a descriptive study which aims to determine the long-term cost savings for TAVI procedures compared to SAVR procedures. This will be achieved by quantifying the healthcare resource utilisation of a SAVR cohort of patients compared to a TAVI cohort including secondary care activity such as re-admissions, length of stay and primary care activity. The study design has been chosen as this is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for procedures, demographics, costs, complications, readmissions and resource use.
We shall describe the cohort in terms of a risk score based on a proxy of the Society of Thoracic Surgery (STS) risk score. Health care resource usage for the cohort will be calculated and reported for readmissions, outpatient appointments, length of stay, and primary care appointments. Outcomes and the incidence of procedure-related complications in the two chosen and matched cohorts. will be described as total, means, medians, percentage, or rates as appropriate.
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Comparing the Estimated Risk of Hip Fracture Among Subjects Exposed to Tramadol as Compared to Subjects Exposed to Codeine — Erica Voss ...
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Comparing the Estimated Risk of Hip Fracture Among Subjects Exposed to Tramadol as Compared to Subjects Exposed to Codeine
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-31
Organisations:
Erica Voss - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Erica Voss - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Arun Singh - Collaborator - Janssen US
Daniel Fife - Collaborator - Johnson & Johnson ( JnJ - USA )
Gowtham Rao - Collaborator - Janssen US
Martijn Schuemie - Collaborator - Janssen US
Peter Rijnbeek - Collaborator - Erasmus University Medical Center ( EMC )
Rana Saberi - Collaborator - Janssen USOutcomes:
1 Outcome of Interest: Hip Fracture
101 Negative Control Outcomes (See Appendix A, some examples of the negative controls include epidermoid cyst, and neutropenia, tooth loss)Description: Technical Summary
Hip fractures greatly impact an individualÂs quality of life and carry a high risk of death within 1 year. Tramadol is a commonly used weak opioid for treatment of pain. A recent study by Wei et al. found that risk for hip fractures was higher for new users of tramadol than for new users of codeine. We had concerns in the way Wei et al. designed their study specifically. We plan to replicate the Wei et al. design as well as perform additional analysis that address the limitations  specifically creating tramadol and codeine cohorts that are more comparable. While the propensity score was not described in detail within Wei et al.Âs work, we will implement large-scale propensity score fitting. Wei et al. also only used one data source, this study will use 4 databases total (one like what was used in the original work and 3 US claims datasets). Finally, for the comparisons being performed, negative controls will be implemented to check for residual confounding and adjust the p-value.
We propose to do a study to assess hip fracture incidence among users of tramadol versus codeine that will reassess the relationship and address the Wei et al. study limitations.
Source -
Helicobacter pylori infection, its treatment and colorectal cancer risk: A two-phase study using treatment data from the UK Clinical Practice Database and serology information from the UK biobank — Monica DArcy ...
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Helicobacter pylori infection, its treatment and colorectal cancer risk: A two-phase study using treatment data from the UK Clinical Practice Database and serology information from the UK biobank
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-20
Organisations:
Monica DArcy - Chief Investigator - National Cancer Institute ( NCI )
Monica DArcy - Corresponding Applicant - National Cancer Institute ( NCI )
Maria Constanza Camargo - Collaborator - National Cancer Institute ( NCI )
Mitchell Gail - Collaborator - National Cancer Institute ( NCI )
Ruth Pfeiffer - Collaborator - National Cancer Institute ( NCI )Outcomes:
1. Colorectal cancer (CRC) incidence
2. Gastric cancer incidence
3. Prostate cancer
4. Female Breast cancerDescription: Technical Summary
CRC incidence is substantially higher in western Europe and North America compared to the rest of the world. In part, this is because many of the moderate risk factors associated with CRC (e.g., red meat consumption, processed foods, obesity, smoking, alcohol consumption and sedentary lifestyle) are more prevalent in the west.1
Helicobacter pylori (H. pylori) is responsible for almost 90% of non-cardia gastric cancers.2,3. A review of H. pylori and CRC incidence provided supportive evidence and plausible biological mechanisms by which H. pylori infections may also increase risk of CRC incidence or CRC precursor lesions.4 The evidence is limited, especially in western Europe and North America. If H. pylori infections increase the risk of CRC or its precursors, it is reasonable to ask if treating H. pylori infections could substantially reduce the burden of CRC in the west as H. pylori treatment has reduced gastric cancer incidence in the east. This question has not however been addressed.
In this study, we will examine the association between H. pylori eradication treatment and CRC risk using a case-control study supplemented with serology information from the UK Biobank using novel statistical methods. Unlike the UK Biobank, the CPRD does not contain serologically confirmed H. pylori status. We will use information obtained from our UK Biobank study where HP status is measured on a subset of participants (N~10,000) to estimate the probability that a person is H. pylori+ given that s/he was not treated. This information can then be combined with the CPRD data to estimate the treatment effect on CRC risk among individuals predicted to be H. pylori+ using an estimating equations approach or a mixture model. We will test our novel approach with a positive control outcome (gastric cancer) and negative control outcomes (cancer of the prostate and female breast).
Source -
Long-acting insulin analogues and the risk of diabetic retinopathy, neuropathy, and nephropathy in type 2 diabetes patients. — Samy Suissa ...
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Long-acting insulin analogues and the risk of diabetic retinopathy, neuropathy, and nephropathy in type 2 diabetes patients.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-31
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Shahrzad Salmasi - Collaborator - McGill University
Stephanie Larose - Collaborator - McGill UniversityOutcomes:
Retinopathy:
Primary:
Incident diabetic retinopathy
Secondary:
Incident non-proliferative diabetic retinopathy
Incident proliferative diabetic retinopathyNeuropathy:
Primary
Incident non-traumatic minor or major lower limb amputation
Secondary:
Incident non-traumatic minor lower limb amputation
Incident non-traumatic major lower limb amputation
Re-Amputation of lower limbNephropathy:
Primary
Nephropathy
Secondary:
Incident chronic kidney disease
End stage renal disease (ESRD)Description: Technical Summary
Insulin analoguesâ flat, long-acting profile and reduced hypoglycemia risk have made them popular choices as basal insulins for many patients with type 2 diabetes. Newer, longer acting and flatter insulins are being tested, and relatively recent additions to the market are the ultra-long-acting insulin analogues glargine 300U and degludec.
While their ability to maintain glycemic control has been compared between NPH and the long-acting analogues, evidence is lacking on comparative risk of microvascular complications (retinopathy, nephropathy, and neuropathy). Some registration studies and RCTs have reported inconsistent results with respect to the impact of glargine and progression of retinopathy compared to NPH, and there are no studies comparing the risk of neuropathy and nephropathy complications between NPH and insulin analogues.
Given the morbidity associated with diabetic microvascular complications and its adverse impact on quality of life, it is important to further assess these important outcomes in a real-world setting. Our study will assess the risk of incident diabetic retinopathy, nephropathy, and neuropathy (as individual endpoints) with the use of long- and ultra long-acting insulin analogues versus with the use of NPH insulin among patients with type 2 diabetes using the United Kingdomâs (UK) Clinical Practice Research Datalink (CPRD). The primary endpoints will be incident diabetic retinopathy, incident non-traumatic minor or major lower limb amputation, and albuminuria. We will use Cox proportional hazards models to compare event rates with the use of insulin analogues to those with the use of NPH insulin. Secondary analyses will examine if the risks differ by molecule, duration of use, sex, age, or prior history of other microvascular or macrovascular complications.
Source -
Antibiotic treatment and major bleeding in anticoagulant medication users: analysis of health record data to support safer monitoring and prescribing — Harry Ahmed ...
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Antibiotic treatment and major bleeding in anticoagulant medication users: analysis of health record data to support safer monitoring and prescribing
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-08-13
Organisations:
Harry Ahmed - Chief Investigator - Cardiff University
Harry Ahmed - Corresponding Applicant - Cardiff University
Daniel Farewell - Collaborator - Cardiff University
Heather Whitaker - Collaborator - Public Health England
Hywel M. Jones - Collaborator - Cardiff University
Julia Hippisley-Cox - Collaborator - University of Oxford
Simon Noble - Collaborator - Cardiff UniversityOutcomes:
The primary outcome is major bleeding.
Secondary outcome is clinically relevant non-major bleeding (CRNMB).
To estimate the risk of major bleeding, we will use linked hospital and death registry data to ascertain the following:
1. Hospitalisation with Intracranial bleeding (ICD-10 codes I6xx, S065 and S066)
2. Hospitalisation with Gastrointestinal bleeding (ICD-10 codes I850, K2xx, K3xx, K625, K9xx)
3. Death from either of the above.
To estimate the risk of CRNMB, we will use GP and hospital data to ascertain a clinical presentation with less serious bleeds - haemoptysis, epistaxis, and haematuriaDescription: Technical Summary
Background
Depending on the specific drug, 2-4% of anticoagulant medication users have a major bleed needing hospitalisation, of whom 20% die within 30 days. Several studies have implicated antibiotic-anticoagulant drug-drug interactions as the likely cause of a significant number of bleeds in anticoagulant medication users, but previous estimates of the risk of bleeding associated with specific antibiotics are inconsistent and do not fully account for the risk related to the underlying infection.
Aim
This project aims to determine the risk of major bleeding associated with infection and antibiotic treatment in anticoagulant medication users and effectively disseminate the findings to improve care and help reduce the incidence of these adverse outcomes.
Methods
We will address the research aim through a series of epidemiological studies using prescribing, hospital admission, and mortality data from the Clinical Practice Research Datalink (CPRD). We will identify a cohort of new anticoagulant medication users in the CPRD (incident user design). Associations between treatment with different antibiotics and major bleeding will be determined in two ways. First, a retrospective cohort study using logistic regression models to estimate odds of bleeding associated with the 10 most commonly prescribed antibiotics in the UK, using amoxicillin as an active comparator. Second, a propensity score matched cohort study estimating the odds of bleeding for antibiotics recommended for the same indication. A third study will use a self-controlled case series design to determine the impact of infection without antibiotic treatment on bleeding risk. Estimates for warfarin and Direct Oral Anticoagulants will be reported separately. Outcomes will include death or hospitalisation from gastrointestinal or intracranial bleeding and clinically relevant non-major bleeding. Several sensitivity analyses will test the robustness of the findings using methods such as negative control exposures and negative control outcomes.
Source
2020 - 07
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ADR Wales Covid-19 Response — unknown...
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ADR Wales Covid-19 Response
Where: unstated
When: 2020-7-6
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Data scientists from ADR Wales are currently undertaking a collection of rapid response projects related to the Covid-19 pandemic. These projects are looking at the experiences of those that have been placed on the shielded list in Wales and those that live with a shielded individual, in particular their interactions with health services prior to and during the shielding period.
Published updates:
Shielding teachers and teaching assistants during the pandemic in June 2020 (published July 2020)
Children living in shielded households in June 2020 (published August 2020)
Shielded patientsâ access to private outdoor space in June 2020 (published August 2020)
Composition and characteristics of shielded households in July 2020 (published November 2020)
Findings from this work are directly informing the One Wales response to Covid-19, which regularly feeds into Wales Technical Advisory Group (TAG) and UK SAGE updates.
Source -
Covid-19 Testing Results
111 (Aggregate (small numbers not supressed)) (Secondary Uses) — Local Authorities...
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Disclosure of aggregate Pillar I and Pillar II testing data by local authority aggregated by LSOA (Lower Layer Super Output Areas), through restricted access dashboards hosted by NHS Digital to aid Local Authorities and associated organisations that form Local Resilience Forums in understanding trends in the progression of Covid-19 by in their local area and facilitate local decision-making on handling rising infection levels in the population. — IG-00637_2
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care Public Health England NHS England Local Resilience Forums CCGs and CSUs NHS Trusts and GP Practices
Approval Date: 03/07/2020
Purpose for which the data is being used: Disclosure of aggregate Pillar I and Pillar II testing data by local authority aggregated by LSOA (Lower Layer Super Output Areas), through restricted access dashboards hosted by NHS Digital to aid Local Authorities and associated organisations that form Local Resilience Forums in understanding trends in the progression of Covid-19 by in their local area and facilitate local decision-making on handling rising infection levels in the population.
Dataset: Covid-19 Testing Results 111
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data.
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only and does not fall within the scope of the GDPR
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data.
GDPR and Data Protection Act 2018: Not applicable - Aggregate data only does not fall within the scope of the GDPR
National Data Opt-out Applied: Not Applied - the data is not patient identifiable.
Source -
Shielded Patient List (SPL) (Aggregate (small numbers supressed)) (Secondary Uses) — Local Authorities...
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To present regional and local data, with disease groups and partial postcodes to allow for its use in public health and allow for greater analysis, modelling and planning to be performed using current data to aid in the response to the pandemic. — IG-00613_2
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care Public Health England NHS England CCGs and CSUs NHS Trusts and GP Practices
Approval Date: 28/07/2020
Purpose for which the data is being used: To present regional and local data, with disease groups and partial postcodes to allow for its use in public health and allow for greater analysis, modelling and planning to be performed using current data to aid in the response to the pandemic.
Dataset: Shielded Patient List (SPL)
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Shielded Patient List (SPL) (Identifiable) (Care and Support to Individual) — Local Authorities...
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To enable Local Authorities to contact shielded patients to advise them of the actions they should take in response to a local COVID-19 outbreak. Local Authorities will also be able to use this information to prioritise contacting those individuals to offer them help, social care and support. — IG-00787
Recipient Data Controller Organisation(s) : Local Authorities
Approval Date: 24/07/2020
Purpose for which the data is being used: To enable Local Authorities to contact shielded patients to advise them of the actions they should take in response to a local COVID-19 outbreak. Local Authorities will also be able to use this information to prioritise contacting those individuals to offer them help, social care and support.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Care and Support to Individual
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Demographic (Pseudonymised and Identifiable) (Secondary Uses) — Department of Health and Social Care...
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Sharing of demographic details of patients in England with IPSOS MORI on behalf of the Department of Health and Social Care to invite volunteers to participate in the Real-time Assessment of Community Transmission (REACT) Antigen Research Study carried out by Imperial College London to help the Government measure the prevalence of COVID-19. — IG-00502_2
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 09/07/2020
Purpose for which the data is being used: Sharing of demographic details of patients in England with IPSOS MORI on behalf of the Department of Health and Social Care to invite volunteers to participate in the Real-time Assessment of Community Transmission (REACT) Antigen Research Study carried out by Imperial College London to help the Government measure the prevalence of COVID-19.
Dataset: Demographic
Category of Data: Pseudonymised and Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR 9(2)(j) â Scientific research DPA 2018 Part 1 Schedule 1 para 4 â Research
National Data Opt-out Applied: Not Applied â disclosure of demographic information and therefore NDOP does not apply.
Source -
Hospitalisation in England Surveillance System (CHESS) data
Intensive Care National Audit & Research Centre
(ICNARC) data
Hospital Episode Statistics (HES)
Emergency Care Data Set (ECDS) (Aggregate (small numbers not supressed)) (Secondary Uses) — All NHS Hospital Trust...
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To enable accurate critical care capacity planning by NHS trusts during the Covid-19 pandemic. NHSE/I will use for regional and national based capacity planning. PHE will use the data for data quality reporting and publication of national statistics, in partnership with NHS Digital. — IG-00421_3
Recipient Data Controller Organisation(s) : All NHS Hospital Trust NHS England and Improvement Public Health England
Approval Date: 10/07/2020
Purpose for which the data is being used: To enable accurate critical care capacity planning by NHS trusts during the Covid-19 pandemic. NHSE/I will use for regional and national based capacity planning. PHE will use the data for data quality reporting and publication of national statistics, in partnership with NHS Digital.
Dataset: Hospitalisation in England Surveillance System (CHESS) data Intensive Care National Audit & Research Centre (ICNARC) data Hospital Episode Statistics (HES) Emergency Care Data Set (ECDS)
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice â NHS Trusts, PHE & DHSC COPI Regulations 3(1) and 3(3) â NHSE/I
Common Law Duty of Confidentiality: General COPI Notice â NHS Trusts, PHE & DHSC COPI Regulations 3(1) and 3(3) â NHSE/I
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation - NHS Trusts, PHE & DHSC GDPR Article 6(1)(e) â Public task - NHSE/I GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Demographic (Identifiable) (Secondary Uses) — Public Health England...
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NHS Digital will share demographic information for 840 people who have been advised to shield. PHE via their processor Bristol, North Somerset and South Gloucestershire will use the data provided by NHS Digital to contact the individualâs by letter inviting them to take part in a survey. — IG-00900
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 28/07/2020
Purpose for which the data is being used: NHS Digital will share demographic information for 840 people who have been advised to shield. PHE via their processor Bristol, North Somerset and South Gloucestershire will use the data provided by NHS Digital to contact the individualâs by letter inviting them to take part in a survey.
Dataset: Demographic
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: COPI Regulations 3(1) and 3(3)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(i) â Public health DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Applied
Source -
Hospital Electronic Prescribing and Medicines Administration (HEPMA) data for COVID-19 response (Anonymised ) (Secondary Uses) — NHS Health Boards...
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To update Hospital Electronic Prescribing and Medicines Administration (HEPMA) systems so that more medicines are NHS Dictionary of Medicines and Devices (dm+d) coded. This updating process supports improved interoperability of HEPMA data. — IG00305_2
Recipient Data Controller Organisation(s) : NHS Health Boards
Approval Date: 23/07/2020
Purpose for which the data is being used: To update Hospital Electronic Prescribing and Medicines Administration (HEPMA) systems so that more medicines are NHS Dictionary of Medicines and Devices (dm+d) coded. This updating process supports improved interoperability of HEPMA data.
Dataset: Hospital Electronic Prescribing and Medicines Administration (HEPMA) data for COVID-19 response
Category of Data: Anonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: Public Health etc. (Scotland) Act 2008
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: N/A â not applicable in Scotland.
Source -
Unique Property Reference Number (UPRN) & NHS Number Dataset (Aggregate (small numbers supressed)) (Secondary Uses) — Public Health England...
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To understand the transmission rate within the household and to inform lockdown policy. — IG-00350_2
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 20/07/2020
Purpose for which the data is being used: To understand the transmission rate within the household and to inform lockdown policy.
Dataset: Unique Property Reference Number (UPRN) & NHS Number Dataset
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Covid-19 Testing Results
111 (Aggregate (small numbers not supressed)) (Secondary Uses) — Local Authorities...
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Disclosure of aggregate Pillar I and Pillar II testing data, and 111 triage data, through restricted access dashboards hosted by NHS Digital to aid Local Authorities and relevant health and care organisations in understanding trends in the progression of Covid-19 in their local area and facilitate local decision-making on handling rising infection levels in the population. — IG-00637_3
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care Public Health England NHS England CCGs and CSUs NHS Trusts and GP Practices
Approval Date: 14/07/2020
Purpose for which the data is being used: Disclosure of aggregate Pillar I and Pillar II testing data, and 111 triage data, through restricted access dashboards hosted by NHS Digital to aid Local Authorities and relevant health and care organisations in understanding trends in the progression of Covid-19 in their local area and facilitate local decision-making on handling rising infection levels in the population.
Dataset: Covid-19 Testing Results 111
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice NHSE/I COPI Notice
Common Law Duty of Confidentiality: General COPI Notice NHSE/I COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source - and 25 more projects — click to show
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Re-evaluating the cost effectiveness of implantable cardioverter defibrillator (ICD) or cardiac resynchronisation
therapy with defibrillation (CRT-D) for heart failure using real world data from the Clinical Practice Research Datalink — Puja Myles ...
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Re-evaluating the cost effectiveness of implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy with defibrillation (CRT-D) for heart failure using real world data from the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-28
Organisations:
Puja Myles - Chief Investigator - CPRD
Tarita Murray-Thomas - Corresponding Applicant - CPRD
Alex Bottle - Collaborator - Imperial College London
Martin Cowie - Collaborator - King's College London (KCL)
Reza Skandari - Collaborator - Imperial College LondonOutcomes:
- HF treatment patterns (prescription rate, combination therapy, optimal therapy)
- HF treatment adherence
- HF complication rates
- Health care resource use and cost (any cause, and HF-related)
- Hospitalisations (any cause, and HF-related)
- Mortality (All cause, Cardiovascular- related, HF-related)
- Combined end point of hospitalisation or mortalityDescription: Technical Summary
Clinical guidance on implantable cardioverter defibrillator and cardiac resynchronisation therapy (ICD/CRT-D) for treating heart failure is largely based on clinical and cost effectiveness evidence from randomised controlled trials (RCTs). However, RCTs may not be representative of HF patients in clinical practice or reflect health service delivery patterns. Primary care data from CPRD, linked to hospital, mortality and deprivation data, will be used to assess heart failure management in practice to re-evaluate economic models on the cost effectiveness of ICD/CRT-D for HF, compared with HF drug therapy alone.
Patients 18 years and older with incident heart failure recorded during 01/01/2008-31/12/2018 will be included. Patients clinical characteristics, HF drug treatment patterns, treatment adherence and its determinants, use of health services and associated costs, rates of hospitalisation, complications, and all-cause, HF and cardiovascular mortality will be evaluated. Clinical characteristics, drug treatment patterns, clinical outcomes and health service use and cost will be presented using appropriate descriptive statistics. Treatment adherence will be assessed using proportion of days covered and medication possession ratio; determinants will be assessed using logistic regression analysis. Hospitalisations per 1,000 patient-years will be estimated and observed cumulative survival will be examined using KaplanÂMeier survival estimation.
Analyses will also be stratified by relevant subgroups including age-group, gender and HF sub-groups at 3, 6, 12, 24 and 60 months. Estimates will be compared with that from RCTs and other key studies on ICD/CRT-D. The cost effectiveness of ICD/CRT-D will be evaluated as the cost per quality-adjusted-life year gained in economic analysis employing a decision analytic framework and also patient level cost effectiveness analysis. Results from this study and our economic analysis may provide valuable insights on whether data from everyday clinical practice could inform policy decisions about the introduction of HF treatments in the NHS.
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Adverse pregnancy outcomes and maternal cardiometabolic health: an observational cohort study using electronic medical records — Abigail Fraser ...
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Adverse pregnancy outcomes and maternal cardiometabolic health: an observational cohort study using electronic medical records
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-28
Organisations:
Abigail Fraser - Chief Investigator - University of Bristol
Kate Birnie - Corresponding Applicant - University of Bristol
Alun Hughes - Collaborator - University College London ( UCL )
Deborah Anne Lawlor - Collaborator - University of Bristol
Kate Tilling - Collaborator - University of Bristol
Laura Howe - Collaborator - University of Bristol
Maria Christine Magnus - Collaborator - Norwegian Institute of Public Health
Neil Davies - Collaborator - University of Bristol
Rosie Cornish - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of BristolOutcomes:
Primary outcomes: CVD risk scores and CVD events: BMI; systolic blood pressure; diastolic blood pressure; total cholesterol; HDL cholesterol; glucose; HbA1c or diabetes as a categorical variable; QRISK3 scores will be generated.
Description: Technical Summary
Adverse pregnancy outcomes (APOs: still birth, miscarriage, hypertensive disorders of pregnancy, gestational diabetes, pre-term delivery and delivering a small- or large-for gestational-age baby) are associated with an approximate doubling of maternal cardiovascular disease (CVD) risk in later life. Clinical guidelines recommend referring women with a past APO for monitoring and control of CVD risk factors. However, clinicians lack guidance on what to monitor and when.
We aim to understand the role of APOs on womenÂs cardiometabolic health, to (i) determine when women with APOs cross established treatment thresholds (e.g. with statins), (ii) whether APOs improve the accuracy of predicting incident CVD in women beyond established tools (QRISK3), (iii) whether differences in cardiometabolic health already exist before pregnancy or emerge post-pregnancy.
We will conduct a prospective cohort study using primary care data from the Clinical Practice Research Datalink (CPRD), linked to information on incident fatal and nonfatal CVD from Hospital Episodes Statistics (HES) and Office of National Statistics (ONS) Mortality Database. Will use multi-level models to account for clustering of repeated measures within individuals to estimate trajectories of cardiovascular risk factors and 10-year cardiovascular risk (according to QRISK3) for women with and without APOs. As part of this, we will also study in detail the relationship between pre-pregnancy cardiovascular risk factors and risk of APOs in order to (i) determine the extent to which differences in risk profiles exist prior to pregnancy and (ii) allow for accurate modelling of confounders in the analysis.
This work will inform CVD screening and prevention strategies in women and shed light on the role of APOs in the aetiology of CVD.
Source -
An investigation of excess mortality and end-of-life morbidity patterns before and during the COVID-19 pandemic. A retrospective analysis using primary care data — Iain Carey ...
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An investigation of excess mortality and end-of-life morbidity patterns before and during the COVID-19 pandemic. A retrospective analysis using primary care data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-29
Organisations:
Iain Carey - Chief Investigator - St George's, University of London
Iain Carey - Corresponding Applicant - St George's, University of London
David Strachan - Collaborator - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
Mortality (All and by Cause of Death); Emergency Hospitalisations (All and by reason for admission)
Description: Technical Summary
Preliminary analyses during the COVID-19 pandemic have reported higher risks among people from Black, Asian and Minority Ethnic (BAME) backgrounds, those living in more deprived areas, and those with existing co-morbidities including diabetes. Regional variations in BAME groups and deprivation, combined with the progress of the UK epidemic may partially explain these differences, as could higher prevalences of obesity, cardiovascular disease, diabetes and associated treatments. Initial reporting largely focused on COVID-19 hospital deaths, where coding may not have been consistent throughout. Focusing on these deaths assumes that there has not been an indirect impact on mortality, with people avoiding secondary care. Therefore, a fuller assessment of the impact of COVID-19 needs to consider excess all-cause mortality as a measure of impact, while still accounting for these individual characteristics.
We will combine data from Aurum and GOLD to estimate excess mortality rates among registered adults during the pandemic period (mid-March to mid-June 2020) compared to corresponding periods in the previous ten years. Poisson regression will be used to compare excess mortality rates between pre-defined groups of interest (BAME, deprivation, co-morbidities), estimating how much the excess rate widened in 2020 for these groups. The models will seek to explain ethnic and socio-economic variations by including other individual level modifiers of COVID-19 risk such as age, smoking, obesity and pre-existing medical conditions.
Finally, we will investigate how COVID-19 has impacted on compression of morbidity. Focusing on the last 5 years of life, we will compare morbidity in all patients who died between 2010-2020 to see whether those dying recently have more morbidity before death than those dying 10 years previously, and whether there are variations by ethnicity and deprivation. Analyses will control for age at death, and a matched comparison group will be used to account for any temporal trends in recording.
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Descriptive analysis of patterns of primary care demand in England during the COVID-19 pandemic — Toby Watt ...
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Descriptive analysis of patterns of primary care demand in England during the COVID-19 pandemic
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-07
Organisations:
Toby Watt - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Ann Raymond - Collaborator - The Health Foundation
Elizabeth Crellin - Collaborator - The Health Foundation
Emma Vestesson - Collaborator - The Health Foundation
Hanifa Pilvar - Collaborator - Queen Mary University of London
Mai Stafford - Collaborator - The Health Foundation
Miqdad Asaria - Collaborator - The Health Foundation
Stephen Rocks - Collaborator - The Health FoundationOutcomes:
Primary care consultation rates  key patient groups are: age; sex; ethnicity; reasons for consultation or diagnosis (including COVID-19); consultation type; practice staff role; outcome of consultation (referral, prescribing, test, immunisation); mortality (using the ONS linkage); patient-level Index of Multiple Deprivation; the presence of pre-existing long-term condition: Cancer, Diabetes, Heart Failure, Coronary Heart Disease, Atrial Fibrillation, Asthma, Chronic Obstructive Pulmonary Disorder, Stroke, Chronic Kidney Disease, Chronic Liver Disease, Depression, Anxiety, Dementia
Description: Technical Summary
The aim of the study is to produce summary statistics on the use of primary care at a high level, by age, sex:
1. Consultation type (e.g. face-to-face, telephone) and role of staff member conducting consultation.
2. We will then look at changes in the reason for consultation through the diagnosis codes: showing the mention of a conditions or COVID-19,
3. The outcomes of consultations (referrals, prescribing, tests, immunisation),
4. Using diagnosis codes (Read and SNOMED) from the patientÂs historical data, we will look at changes in items 1-3 for patients with pre-existing long-term conditions and by ethnicity (sometimes recorded in observation file in CPRD Aurum) and finally:
5. We will look at items 1-4 by patient-level Index of Multiple DeprivationWe will present the weekly means of primary care activity and mortality for different groups (age, sex, ethnicity, pre-existing condition and local IMD) in 2020 and for the same periods from the past 4 years (2016-2019), while taking into account trends in activity levels for those groups using a simple time series trend analysis, taking into account observed seasonality in primary care use and mortality. This analysis will be performed on consultation rates and mortality rates per person in the defined groups. We will then perform similar time trend analysis on the per consultation rates for face to face / phone, referral rates, prescribing rates, testing and where the diagnosis code refers to a pre-existing condition / COVID-19.
An early, high level understanding of the effect of COVID-19 on primary care use will inform policy in how best for the NHS to recover, in addition it will inform areas for further research on the impact of COVID-19 on non-COVID patients.
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Bleeding events and adverse reactions in UK patients with venous thromboembolism (VTE) treated with edoxaban — FLORENT Guelfucci ...
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Bleeding events and adverse reactions in UK patients with venous thromboembolism (VTE) treated with edoxaban
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-15
Organisations:
FLORENT Guelfucci - Chief Investigator - Syneos Health Commercial France SARL
FLORENT Guelfucci - Corresponding Applicant - Syneos Health Commercial France SARL
Brian Buysse - Collaborator - Syneos Health
Florence Bianic - Collaborator - Syneos Health ( inVentiv Health Clinical )
Petra Laeis - Collaborator - Daiichi-Sankyo Europe
Stefano Perni - Collaborator - Syneos HealthOutcomes:
The primary outcomes will be:
Safety measures:
- Bleedings:
- Major bleeding (see Section N. Exposures, Outcomes and Covariates for details)
- Non-major bleeding (see Section N. Exposures, Outcomes and Covariates for details)
- Adverse drug reactions (see Section N. Exposures, Outcomes and Covariates for details)
- Mortality: All-cause mortality, VTE-related, CV mortalityEffectiveness measures: VTE recurrence
The secondary outcomes will be:
Efficacy measures
- recurrence rate of VTE for patients on edoxaban
- recurrence rate of VTE for patients who permanently discontinued edoxabanSafety measures
- Stroke (ischaemic and haemorrhagic)
- Systemic Embolic Events (SEE)
- Hospitalizations related to cardiovascular (CV) condition (including VTE related hospitalisation)
- Post Thrombotic Syndrome (PTS)Description: Technical Summary
Daiichi-Sankyo is currently undertaking a non-interventional post-approval safety study (ETNA study - EU-PAS register numbers EUPAS15504), in order to understand the risks and benefits of edoxaban in the Âreal-worldÂ, as part of the Risk Management Plan of edoxaban. The ETNA-VTE study aims to gain insight into the safety of edoxaban in non-preselected patients with VTE treated with edoxaban.
In this non-interventional retrospective study we aim to evaluate the safety and efficacy of edoxaban in patients diagnosed with venous thromboembolism (VTE) between 2015 and 2019 in the United Kingdom, using the Clinical Practice Research Datalink (CPRD) both Aurum and GOLD with linkage to Hospital Episode Statistics (HES) databases. This study will provide supporting evidence to the ETNA-VTE study and highlight specific information for UK.
We will use Hospital Episode Statistics (HES) data to identify clinical events of interest, hospitalisations, all causes and related to specific conditions. Linkage to Office of National Statistic (ONS) will allow the determination of mortality rates (all-causes, CV- or VTE- specific).
The primary analysis will estimate the overall diagnosed VTE recurrence rate and the frequency of occurrence of safety events, including major bleeding events, non-major bleeding drug-related adverse events, mortality, in patients with VTE treated with edoxaban during an overall observational period of 18 months.
Secondary analysis will assess the impact of edoxaban level of exposure on endpoints such as: stroke (ischaemic and haemorrhagic), systemic embolic events (SEE), hospitalizations related to CV condition including VTE-related hospitalisation, Post-thrombotic syndrome (PTS) and malignancy.
Comparisons of various subgroups and covariates will be done via adjusted Cox proportional hazard regression models presenting hazard ratios and corresponding 95% confidence intervals.
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Using Real-World Data to Examine the Impact of Different Target Populations on the Representativeness of Cardiovascular Outcome Trials of Antidiabetic Drugs — Samy Suissa ...
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Using Real-World Data to Examine the Impact of Different Target Populations on the Representativeness of Cardiovascular Outcome Trials of Antidiabetic Drugs
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-29
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Devin Abrahami - Collaborator - McGill University
Elodie Baumfeld Andre - Collaborator - Roche
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Vaishali Sahasrabudhe - Collaborator - Pfizer Ltd - UKOutcomes:
Percent eligible in the target population after applying the inclusion and exclusion criteria of the LEADER trial.1
Description: Technical Summary
Cardiovascular outcome randomized controlled trials (CVOTs) are conducted among patients with type 2 diabetes at high risk of cardiovascular outcomes to evaluate the cardiovascular safety of antidiabetic drugs. However, type 2 diabetes is a heterogenous disease, and multiple clinically relevant subgroups remain underrepresented in these trials. This has resulted in regulatory concerns regarding the applicability of the safety results from the CVOT in the larger population of patients with type 2 diabetes. Simultaneously, this has resulted in a limited incorporation of the trial results in clinical guidelines, as the trials are unable to provide guidance for patients who are not at a high risk of cardiovascular disease. Thus, examining the representativeness of CVOTs to wider populations of drug users in diabetes is of critical importance. To this end, using the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial of liraglutide as an illustrative example, we will examine its representativeness based on three different target populations: all patients with type 2 diabetes, liraglutide users, and liraglutide candidates. Liraglutide candidates are a target population comprising of individuals who are eligible to receive liraglutide according to treatment guidelines. Using the CPRD, we will identify these three target populations. We will then apply the eligibility criteria of the LEADER trial on each target population and determine the percentage of individuals in the target who would be eligible to be included in the LEADER trial. We will use a logistic regression model to calculate the propensity score distance between the entire target population and the individuals within the target who are eligible for the LEADER trial. Together, this study will determine the ideal target populations and the appropriate measures to be used while determining the representativeness of CVOTs.
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The economic burden of dementia and associated research funding in the United Kingdom in 2018: a comparative study of four chronic conditions — Ramon Luengo...
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The economic burden of dementia and associated research funding in the United Kingdom in 2018: a comparative study of four chronic conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-29
Organisations:
Ramon Luengo-Fernandez - Chief Investigator - University of Oxford
Filipa Landeiro - Corresponding Applicant - University of Oxford
Callum Harris - Collaborator - University of Oxford
Jose Leal - Collaborator - University of Oxford
Samuel O'Neill - Collaborator - NHS ScotlandOutcomes:
1.     Total economic burden of dementia, CHD, stroke and cancer care in 2018 in the UK (specifically, health, social care, and other costs associated with productivity losses and informal care costs).
2. Total research funding allocated to each of dementia, CHD, stroke and cancer in 2018 in the UK.Description: Technical Summary
In 2008, the economic burden of dementia to society was estimated as £23 billion a year, more than the costs of CHD and cancer, combined. This estimate considered the significant economic burden on informal caregivers (unpaid friends and relatives) as well as the productivity losses associated with working-age patients who are unable to work after dementia onset.
This study will provide an estimate of the economic burden of dementia care in the UK in 2018 and compare it with CHD, stroke and cancer. CALIBER open access resource was used to derive the CPRD Aurum codes for each of the four conditions in order to obtain data on visits to primary and secondary care attributable to each of these conditions. Visits to primary and to secondary care for each of these four conditions will be modelled to estimate the amount of resources consumed. The degree to which the resource use for each condition has changed over the last ten years will also be determined using the data from previously published work (1) (2).
A prevalence-based approach for the year 2018 will measure all costs, regardless of disease onset time. Data from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) will be used to estimate the healthcare resources used  primary care, inpatient, outpatient and accident and emergency (A&E) contacts - and costs incurred by people with any of the four conditions of interest. Office for National Statistics (ONS) mortality data linked to CPRD will be used to capture those who died in the community before accessing medical care. In separate analyses, national data from Department for Work and Pensions and ONS will inform lost earnings due to incapacity and mortality. The conclusions of this study will be used to guide future decisions about health care research funding allocation.
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Prevalence of haematuria and its association with risk of urinary tract cancer: a case-control study using real-world data from UK primary care — Robert Carroll ...
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Prevalence of haematuria and its association with risk of urinary tract cancer: a case-control study using real-world data from UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-19
Organisations:
Robert Carroll - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Alex Simpson - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sanket Parmanick - Collaborator - Mu SIgmaOutcomes:
The primary outcome of this study is urinary tract cancer as defined by codes in Table 1 of Appendix A. In addition overall survival following urinary tract cancer diagnosis will be an exploratory outcome.
Description: Technical Summary
Haematuria is the most common symptom for urinary tract cancer, particularly in those aged ? 60 years old and where the haematuria has developed without obvious explanation. In most instances of cancer, symptoms are not very apparent until a later stage of the disease, where survival outcomes are impacted by delays in diagnosis of the disease. Having an easily identifiable symptom such as haematuria for urinary tract cancer may result in earlier diagnosis and thus improved survival.
In this retrospective case control study patients who developed urinary tract cancer will be matched to similar patients based on age, sex and GP practice; and the frequency of occurrence of haematuria preceding urinary tract cancer will be investigated with conditional logistic regression.
This study will quantify the strength of association between haematuria and urinary tract cancer, and further analyses will also be performed to determine whether the association is modified by sex (females have been shown to have poorer survival outcomes than males urinary tract cancer patients). Furthermore, we will also investigate survival in urinary tract cancer patients (whilst taking into consideration potential confounding factors), and the average time between a patient developing haematuria and then going on to develop urinary tract cancer.
Together, this information will add to the evidence base on the prognostic value of haematuria in the diagnosis of urinary tract cancer in primary care.
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Determining the applicability and feasibility of using regression discontinuity in electronic health record data — Till Bärnighausen ...
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Determining the applicability and feasibility of using regression discontinuity in electronic health record data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-19
Organisations:
Till Bärnighausen - Chief Investigator - University of Heidelberg
Julia Lemp - Corresponding Applicant - University of Heidelberg
Anant Jani - Collaborator - University of Oxford
Christian Bommer - Collaborator - University of Heidelberg
Duy Do - Collaborator - University of Heidelberg
Justine Davies - Collaborator - University of Birmingham
Michaela Theilmann - Collaborator - University of Heidelberg
Pascal Geldsetzer - Collaborator - University of Heidelberg
Sebastian Vollmer - Collaborator - Georg-August-Universität GöttingenOutcomes:
The primary outcomes that we will measure are: future measurements of the exposure variables (e.g. BMI, blood pressure, HbA1c, blood glucose, low-density lipoprotein, thyroid-stimulating hormone level, hemoglobin, and T-score and Z-score for bone mineral density), mortality (overall and by cause of death, such as due to cardiovascular disease when examining the effects of statins), and hospitalization (overall and by cause of admission).
Description: Technical Summary
Regression discontinuity (RD) design  a quasi-experimental method taking advantage of decision rules that assign patients to a clinical intervention if they fall above/below an arbitrary cut-off point  has potential to assess causal effects of clinical interventions. This study seeks to determine the applicability and feasibility of RD in electronic health record data. Specifically, we aim to (1) determine which (if any) laboratory or physical measurements contain thresholds that are associated with a substantial change in the probability of receiving a clinical intervention, (2) evaluate if patient characteristics are balanced within a small bandwidth surrounding these thresholds, and (3) investigate whether associations between the clinical intervention and patient outcomes are robust to different choices of bandwidth around the threshold. Exposure variables include laboratory and physical measurements such as BMI, blood pressure, HbA1c, blood glucose, age, low-density lipoprotein, thyroid-stimulating hormone level, hemoglobin, and T-score and Z-score for bone mineral density. Patient outcomes primarily include future measurements of the exposure variables, mortality (overall and by cause of death, such as due to cardiovascular disease when examining the effects of statins), and hospitalization (overall and by cause of admission). We will estimate Âfuzzy RD models using local linear regression to avoid overfitting data and triangular weights to give more influence to observations close to the threshold. In addition, we will use a mean squared error (MSE) optimal bandwidth that is empirically derived. We assess the sensitivity of the results using alternative bandwidths (e.g. bandwidths that are 50%, 75%, 125%, and 150% of the empirically derived mean squared error-optimal bandwidth). If feasible and widely applicable, RD analyses in electronic health records could generate valuable insights into the real-life effects of clinical interventions on health and health care use, the unintended effects associated with these interventions, and the potential heterogenous treatment effects by detailed patient subgroups.
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Using linked primary care and viral surveillance data to develop risk stratification models to inform management of severe COVID-19 — Rupert Payne ...
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Using linked primary care and viral surveillance data to develop risk stratification models to inform management of severe COVID-19
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ICNARC (COVID-19 Intensive Care National Audit and Research Centre); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-29
Organisations:
Rupert Payne - Chief Investigator - University of Bristol
Rupert Payne - Corresponding Applicant - University of Bristol
Annie Herbert - Collaborator - University of Bristol
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jennifer Cooper - Collaborator - University of Birmingham
Peter Tammes - Collaborator - University of Bristol
Rachel Denholm - Collaborator - University of BristolOutcomes:
Primary outcome
- Admission to intensive care with confirmed COVID-19
- Survival of intensive care admission with confirmed COVID-19
- Duration of intensive care admission with confirmed COVID-19
Secondary outcomes
- Positive test for SARS-CoV-2 (antibody or antigen) result or a coded diagnosis of COVID (GP coded record)
- Unplanned admission to hospital with confirmed COVID-19
- Non-invasive ventilation with confirmed COVID-19
- Duration of mechanical ventilation with confirmed COVID-19
- All death with COVID-19Description: Technical Summary
COVID-19 is a rapidly evolving problem, presenting huge challenges to health services. There is an urgent need for tools to help clinicians, managers and policymakers decide how to optimise social distancing measures and to best deliver services to the most critically ill patients.
The proposed research will take advantage of a new linkage between the Clinical Practice Research Datalink (CPRD) and Intensive Care National Audit and Research Centre (ICNARC), COVID-19 Hospitalisation in England Surveillance System (CHESS) and Second Generation Surveillance (SGSS) datasets and aims to develop a risk stratification tool to determine which patients in primary care are at highest risk of admission to intensive care and which pre-morbid factors predict survival. We will specifically look for causal associations with cardiovascular drug therapy as this is amenable to change and thus a potential opportunity for intervention.
Survival models will be developed to describe the association between key pre-morbid clinical factors (e.g. sociodemographics, comorbidities, prescribing, other clinical factors) and three key outcomes: intensive care admission, intensive care survival, and length of intensive care stay. Standard established methodological approaches to data processing and analysis will be undertaken to minimise the time taken to develop the necessary models. Advanced methodologies to account for known biases (confounding by indication and selection bias) will be used to explore pharmacoepidemiological relationships between cardiovascular medication and COVID-19 outcomes.
The resulting risk stratification tools will have value in identifying individuals at greatest risk of severe illness, enabling more tailored social distancing, facilitating early pre-emptive care, targeting any future vaccine delivery, and planning for use of intensive care facilities. The linked dataset would also facilitate other epidemiological analyses of COVID-19.
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The Incidence of Cancer Overall and Site-Specific Cancer Among Patients with Type 2 Diabetes Between 1988 and 2019 — Samy Suissa ...
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The Incidence of Cancer Overall and Site-Specific Cancer Among Patients with Type 2 Diabetes Between 1988 and 2019
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-07
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Cancer overall and site-specific cancer (cancer of the breast, prostate, lung, colon and rectal, kidney, head and neck, central nervous system, pancreas, bladder, endometrium, oesophagus, ovary, stomach, liver and biliary tract, and thyroid, melanoma and non-melanoma skin cancer, non-Hodgkin lymphoma, leukaemia, and myeloma)
Description: Technical Summary
Epidemiological studies have established the association between diabetes and the risk of cancer. Various factors that might influence the incidence of cancer in diabetes have altered over time. They include the introduction of novel antidiabetic drugs and longer survival of patients with diabetes. Whether the incidence of cancer in patients with diabetes has varied over time is unclear. This study will use the Clinical Practice Research Datalink to assemble patients at least 40 years of age newly-treated for type 2 diabetes between 1988 and 2018. These patients with type 2 diabetes will be matched with non-diabetic individuals using risk set sampling. Poisson regression models conditional on matched pairs will be used to estimate incidence rate ratios with 95% confidence intervals comparing the incidence rates of cancer overall and site-specific cancer, separately, between patients with type 2 diabetes and individuals from the non-diabetic population for each year between 1988 and 2018. Secondary analyses will stratify the incidence by age and sex and examine the effect of duration of diabetes.
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The effectiveness of aspirin in preventing COPD exacerbations: A prevalent new-user cohort study — Samy Suissa ...
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The effectiveness of aspirin in preventing COPD exacerbations: A prevalent new-user cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Anirudh Bakshi - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Moderate or severe COPD exacerbations; All-cause mortality;
Description: Technical Summary
The objective of this study is to evaluate the effectiveness of aspirin use on reducing the incidence of COPD exacerbations and mortality in patients with COPD. We will use the Clinical Practice Research Datalink (CPRD) to form a base cohort of patients with a COPD diagnosis, aged 55 or over, and treated with long-acting bronchodilators. We will use a prevalent new-user design to design the study cohort, whereby for each patient who initiates aspirin during follow-up, a time-conditional propensity score-matched reference subject unexposed to aspiring will be selected from the corresponding exposure set of patients with same time since cohort entry and with a visit to a physician at the time of the exposure set. Thus, the time span between base cohort entry and study cohort entry is inherently a matching covariate. The propensity scores will use a high-dimensional propensity score (HDPS) technique by identifying all available data (e.g., diagnoses, procedures, medications) in the one-year period prior to the date of the matched set and applying conditional logistic regression to estimate the time-conditional propensity score. The matched subjects in the study cohort will be followed for one year from cohort entry, date of death, June 2020, or the end of coverage in the practice, whichever is first. The primary outcome is the first moderate or severe COPD exacerbation to occur after cohort entry, defined as a new prescription for prednisolone during follow-up or hospitalization for COPD as primary cause. A secondary outcome is all-cause mortality. The comparative analysis of time to the first exacerbation and time to death within one year will use a Cox proportional hazard regression model to perform an as-treated analysis to estimate the hazard ratio of COPD exacerbation and mortality with current use of aspirin, also according to platelet counts.
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Asthma epidemiology, prevalence of asthma modifiable factors and healthcare utilisation due to asthma in England, Scotland, Wales, Northern Ireland and the UK — Mome Mukherjee ...
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Asthma epidemiology, prevalence of asthma modifiable factors and healthcare utilisation due to asthma in England, Scotland, Wales, Northern Ireland and the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-08
Organisations:
Mome Mukherjee - Chief Investigator - University of Edinburgh
Aziz Sheikh - Corresponding Applicant - University of EdinburghOutcomes:
i) Incidence of asthma for the UK and its member nations,
ii) prevalence of asthma for the UK and its member nations,
iii) primary care consultations for asthma for the UK and its member nations,
iv) asthma medications (maintenance and reliever medications) for the UK and its member nations,
v) attendance to outpatient clinics for patients with asthma from England whose GP practices consented to data linkage,
vi) attendance to accident and emergency clinics for patients with asthma from England whose GP practices consented to data linkage,
vii) hospitalisations for patients with asthma from England whose GP practices consented to data linkage,
viii) body weight in patients with asthma for the UK and its member nations,
ix) determinable smoking status in patients with asthma for the UK and its member nations,
x) seasonal flu vaccinations in patients with asthma for the UK and its member nations,
xi) asthma self-management plan in patients with asthma for the UK and its member nations,
xii) monitoring of inhaler technique in patients with asthma for the UK and its member nations,
xiii) annual asthma review in patients with asthma for the UK and its member nations.Description: Technical Summary
For the UK and its member nations, we seek to describe the incidence and prevalence of asthma for the UK and its member nations. Our secondary objectives are to describe healthcare utilisation due to asthma and modifiable risk factors for asthma. Healthcare utilisation will include primary care consultations, asthma medications (maintenance and reliever medications), secondary care outpatient and accident and emergency clinics and hospitalisations. Attendance to secondary care clinics and hospitalisations will be described only for patients with asthma from England whose GP practices consented to data linkage. Where possible we will quantify the prevalence of modifiable risk factors for asthma i.e. body weight, determinable smoking status, seasonal flu vaccinations, monitoring of inhaler technique, having an asthma self-management plan, annual asthma review for the four nations of UK. We will stratify the data, where possible, by gender, age-groups, ethnicity, socioeconomic status, country and year. Considering data confidentiality, if the cell counts permit, we would provide estimates for regions in England, Scotland, Wales and Northern Ireland, standardising by age and sex to the relevant nationÂs regional population. We will look at the trend of the outcomes over twenty years, 2000 to 2020. We will use these updated estimates to guide our deliberations with policymakers, health system leaders and our research efforts, which are focused on reducing the current unacceptably high number of asthma hospitalisations and deaths in the UK.
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The SPOtting Cancer among Comorbidities (SPOCC) programme. Work Package 1: Investigating comorbidities impact on intermediate cancer outcomes associated with the diagnostic process; a retrospective cohort study — Gary Abel ...
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The SPOtting Cancer among Comorbidities (SPOCC) programme. Work Package 1: Investigating comorbidities impact on intermediate cancer outcomes associated with the diagnostic process; a retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Patient Experience Survey (CPES) data; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-15
Organisations:
Gary Abel - Chief Investigator - University of Exeter
Luke Mounce - Corresponding Applicant - University of Exeter
Bianca Wiering - Collaborator - University of Exeter
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Jose M Valderas - Collaborator - University of Exeter
Sarah Price - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
We will examine a number of outcomes across the diagnostic pathway for patients with cancer:
Primary outcome
1. Stage at diagnosis (obtained from NCRAS cancer registry linkage): dichotomised to early (stages 0-2) vs advanced (stages 3-4), which will give an overall assessment of disadvantages in diagnostic timeliness.
Secondary outcomes
2. 30-day mortality post diagnosis (NCRAS and ONS death registration)
3. The route to diagnosis (NCRAS): emergency, Two Week Wait referral, GP referral, other)
4. The patient interval (CPES wave 5: days from symptom onset to presentation);
5. The primary care interval (days from first presentation as identified in CPRD to referral as identified in HES)
6. The diagnostic interval (days from first presentation as identified in CPRD to diagnosis as identified in NCRAS)
7. The number of pre-referral consultations (CPES)
8. The number of primary care consultations in the 12 months preceding diagnosis (CPRD). Analysis of this outcome will require a control sample without cancer.Description: Technical Summary
Improving the timeliness of cancer diagnoses is a governmental health priority. These improvements need to be made in the context of the increasing prevalence of long term conditions, which recent evidence suggests may complicate the cancer diagnostic process. The primary aim of this study is to investigate which patients with pre-existing conditions are disadvantaged in the cancer diagnostic process, and the secondary aim is to highlight where in this process the disadvantage occurs. We will utilise anonymised electronic primary care records of approximately 300,000 patients with an incident cancer diagnosed between 2012-2016, linked to National Cancer Registration and Analysis Service (NCRAS) datasets and Hospital Episode Statistics (HES) data. Our primary outcome will be stage at diagnosis (early or advanced), with secondary outcomes including the route to diagnosis, 30-day mortality, how long patients waited before presenting with a symptom of cancer, and the interval between first presentation and referral to secondary care. Morbidity will be operationalised in different ways: single conditions (comorbidities), a count of conditions (multimorbidity), and metrics for the overall burden of conditions (morbidity burden).
Mixed effects regression models, clustering patients by practice, will be used to explore the effect of morbidity constructs on each outcome in turn; logistic regressions for binary data, Poisson regressions for rate data, and time-to-event models appropriate to the data (e.g. flexible parametric survival models). All cancers will be included in each model, with interaction terms between cancer site and morbidity constructs used to highlight disadvantaged subgroups.
Uncovering patient subgroups who are disadvantaged in the cancer diagnostic process, and where this disadvantage occurs, will facilitate; improved targeting of policy, better informed clinical guidance for affected patients, and design and implementation of interventions to reduce the disadvantage.
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Understanding non-recovery after an exacerbation of chronic pulmonary obstructive disease — Chloe Bloom ...
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Understanding non-recovery after an exacerbation of chronic pulmonary obstructive disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-05
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Andy Ritchie - Collaborator - Imperial College London
Gavin Donaldson - Collaborator - Imperial College London
Wisia Wedzicha - Collaborator - Imperial College LondonOutcomes:
COPD exacerbations, respiratory symptoms and antibiotics
Description: Technical Summary
We will draw a cohort of COPD patients and measure the incidence rates of exacerbations, nonrecovery and re-exacerbations. Nonrecovery in this study will be defined as non-resolution of symptoms back to a patientÂs pre-exacerbation baseline level within 21 days after the primary exacerbation. Re-exacerbations will be defined as another exacerbation within 31 days after the primary exacerbation. An open cohort will be used to assess the effect of antibiotics and/or oral corticosteroids as compared to no treatment during a period of nonrecovery, on the risk of a re-exacerbation. The risk will be estimated using propensity score methodology and multivariable Cox regression, with stratification on disease severity. Covariates will include age, gender, smoking history, BMI, socioeconomic status (through IMD linkage), disease severity, past history of exacerbations, comorbidities. HES and ONS linkage will be required as exacerbations can be managed by hospital admission, or can result in death; these outcomes also indicate a more severe exacerbation.
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Strengthening the Evidence-Base for Drug-Disease Interactions in Older Adults — Tobias Gerhard ...
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Strengthening the Evidence-Base for Drug-Disease Interactions in Older Adults
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-15
Organisations:
Tobias Gerhard - Chief Investigator - Rutgers, The State University of New Jersey
Haoqian Chen - Corresponding Applicant - Rutgers, The State University of New Jersey
- Collaborator -
Abner Nyandege - Collaborator - Rutgers, The State University of New Jersey
Amy Tyberg - Collaborator - Rutgers, The State University of New Jersey
Anupa Sharma - Collaborator - Rutgers, The State University of New Jersey
Brian Strom - Collaborator - Rutgers, The State University of New Jersey
Cecilia Huang - Collaborator - Rutgers, The State University of New Jersey
Isao Iwata - Collaborator - Rutgers, The State University of New Jersey
James Flory - Collaborator - Memorial Sloan Kettering Cancer Center
Mary Ritchey - Collaborator - Rutgers, The State University of New Jersey
Naomi Schlesinger - Collaborator - Rutgers, The State University of New Jersey
Reynold Panettieri - Collaborator - Rutgers, The State University of New Jersey
Richard Mann - Collaborator - Rutgers, The State University of New Jersey
Zhiqiang Tan - Collaborator - Rutgers, The State University of New JerseyOutcomes:
Aim 1 Â hospitalization for lactic acidosis, Aim 2 Â hospitalization for hip fracture, Aim 3 Â hospitalization for gastrointestinal bleed, Aim 4 Â dialysis/kidney transplant.
Description: Technical Summary
Using existing data resources on millions of patients from CPRD and US Medicare, the proposed study will use four carefully selected examples of highly prevalent drugs to demonstrate a new methodological framework for the systematic assessment of DDSIs from large observational datasets: metformin and renal impairment increasing risk of lactic acidosis (Aim 1), Z-drugs and osteoporosis increasing risk of hip fracture (Aim 2), systemic corticosteroids and peptic ulcer disease increasing risk of gastrointestinal bleeding (Aim 3), and allopurinol and renal impairment reducing risk of dialysis or kidney transplant (Aim 4). These examples were selected considering a number of explicit criteria including severity of the adverse outcome, disagreement about relevance in the literature and clinical practice, and availability of therapeutic alternatives that do not share the hypothesized DDSI. We included interactions across a spectrum of prevalence and expected effect sizes to evaluate the performance of the proposed approach in different situations and sought some effects very likely to be absent (Aim 1) or present (Aim 2) to show we can reproduce expected findings, and uncertain effects (Aims 3 and 4). The proposed study puts forward a novel framework that comprehensively classifies DDSIs according to their underlying biological mechanisms and represents the first systematic attempt to apply modern epidemiological and statistical methods to the examination of DDSIs. Separate implementation of all aims in two large healthcare databases provides built-in replication of results and facilitates assessment of the robustness of findings to differences in underlying data structure (claims vs. EHRs) and utilization patterns between different countries and health care systems (US vs. UK). Its results will begin a line of work that will ultimately enable physicians to practice evidence-based personalized medicine by providing reliable data on the effects of patient-specific comorbidities on the safety and effectiveness of their therapeutic regimens.
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Hormone replacement therapy and dementia risk: nested case-control studies using CPRD and QResearch — Yana Vinogradova ...
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Hormone replacement therapy and dementia risk: nested case-control studies using CPRD and QResearch
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-12
Organisations:
Yana Vinogradova - Chief Investigator - University of Nottingham
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Carol Coupland - Collaborator - University of Nottingham
Julia Hippisley-Cox - Collaborator - University of Oxford
Lauren Taylor - Collaborator - University of Nottingham
Michael Moore - Collaborator - University of Southampton
Tom Dening - Collaborator - University of NottinghamOutcomes:
First record of diagnosis of dementia in general practice, hospital admission data and ONS Mortality data, or treatment for dementia in general practice.
Description: Technical Summary
The technical summary should provide a succinct overview of the overarching study aim and objectives, primary exposure(s), and outcome(s), if relevant, study design, and methods including the main statistical tests to be used.
Objective:
The study will investigate risks of incident dementia associated with different types of HRT.Outcome:
Incident dementiaExposure:
Prescriptions for HRTMethods:
This will be a nested case-control study. Cases will be women aged 55 years and over with incident dementia diagnosed between 1998 and 2019, matched with up to 5 controls by age, sex, practice and calendar year. Cases will be selected using GP, ONS mortality and HES data.Analysis:
Exposure to different HRTs will be defined as at least one prescription for that HRT excluding three years before the index date (date of diagnosis of dementia or equivalent date in matched controls). Conditional logistic regression will be used to assess the risks associated with different types of oestrogen and progesterone. The effects of duration, length of any gap since the last use, different application routes and the age at which treatment started will be analysed for the most common types of hormones. All analyses will be adjusted by available data for potential confounding variables.
A study using this same protocol will also be carried out using data from another primary care database (QResearch). Adjusted odds ratios from the conditional regression analyses of the two datasets will be pooled using a fixed effect model with inverse variance weights.
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Antibiotic prescribing and risk of herpes zoster: a case-control study — David Armstrong ...
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Antibiotic prescribing and risk of herpes zoster: a case-control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-12
Organisations:
David Armstrong - Chief Investigator - King's College London (KCL)
Alex Dregan - Corresponding Applicant - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)
Patrick White - Collaborator - King's College London (KCL)Outcomes:
The main outcome measure of the study is shingles/herpes zoster. Diagnoses of shingles will be identified using Read medical codes.
Description: Technical Summary
Antibiotics, given to combat a specific infection, may produce collateral damage to the microbiome. This effect may be important as a Âhealthy microbiome seems to be implicated in its hostÂs health. Our group has been investigating this phenomenon in a series of case control studies using primary care data. In these studies we have shown that prior antibiotics increased the risk of bacterial meningitis, we hypothesise by damaging the nasopharyngeal microbiome in which meningitis organisms are often commensals; we have also shown increased risk of rheumatoid arthritis, we hypothesise by interfering with the immune response that is known to be an important function of the gut microbiome; and we have shown an increased risk of colorectal cancer, we hypothesise through damage to the protective effect of gut bacteria. One of the surprising findings in these studies was that prior antibiotics increased the risk of viral meningitis just as much as bacterial meningitis. Antibiotics have no direct effect on viruses so we surmise that change in the bacterial microbiome results in changes in the viral microbiome whether through affecting some immune response or by other ecological mechanisms. We would now like to investigate further this (indirect) relationship of antibiotics to the viral microbiome by seeing whether prior antibiotics increase the risk of reactivating herpes zoster. We therefore propose carrying out a case control study, comparing the antibiotic history of patients with herpes zoster with a control group without the disease. If there is an effect, it may have an important bearing on vulnerability to other viral infections such as covid-19.
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Real-world utilization of and comparative outcomes arising from novel oral anticoagulants for atrial fibrillation and stroke prevention in the United Kingdom — Craig Currie ...
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Real-world utilization of and comparative outcomes arising from novel oral anticoagulants for atrial fibrillation and stroke prevention in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-28
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Cindy Gao - Collaborator - Pharmerit International LP
Rosa Wang - Collaborator - Daiichi Sankyo
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sue Beecroft - Collaborator - Harvey Walsh Ltd
Tracey Ellison - Collaborator - Harvey Walsh Ltd
Xiaocong Li Marston - Collaborator - Pharmerit International LP
Xin (Sam) Ye - Collaborator - Daiichi Sankyo
Yu-Chen Yeh - Collaborator - Pharmerit International LPOutcomes:
Major bleeding (primary) | systemic embolism | ischaemic stroke | mortality | adherence and persistence | healthcare resource use and costs
Description: Technical Summary
Atrial fibrillation (AF), the commonest form of arrythmia (1.5% prevalence), is characterized by irregular, rapid heartbeat increasing the risk of stroke (five times), heart failure, and death (two-fold). In the UK, a quarter of acute vascular events (the majority strokes) are AF-related incurring considerable human and healthcare costs.
AF treatment includes oral anticoagulation, preventing blood clotting, the main driver of the associated stroke risk. Warfarin, the first line, requires careful dosage adjustment and regular blood tests to be used safely. Novel antagonist oral anticoagulant (NOACs) are easier to use and, in clinical trials, reduce stroke risk in AF patients and cause less major bleeding than warfarin. Head-to-head efficacy and safety comparisons between the NOACs and warfarin using observational data have been made, though none from the UK.
Four distinct NOAC drugs available in the UK, the newest of which was introduced between 2008 and 2015. The study will make new-user comparisons between the newest, edoxaban, and each of the other alternative treatments, including warfarin by selecting propensity score (PS)-matched cohorts among anti-coagulant naïve patients with AF.
This study will determine the comparative effectiveness of each NOAC versus warfarin in routine UK clinical practice. Specifically, the study will assess whether in newly-treated patients and compared to warfarin, the use of each NOAC is associated with: 1) the rate of major bleeding (the primary outcome of interest), strokes, mortality; 2) treatment adherence and persistence; and 4) lower overall healthcare resource use and costs.
Time-to-event analyses will use Cox proportional hazards regression, with censoring defined by either treatment switching, non-outcome related death, practice de-registration or database horizon. Generalized linear models will be constructed using the PS-matched cohorts to compare HCRU (Poisson/binomial) and cost (gamma) between treatments. All multivariable models will be adjusted for baseline characteristics, including demography, comorbidities, and clinical status.
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Glycaemic control and diabetes-related health outcomes: longitudinal HbA1c trajectories, cumulative morbidity, and disease transitions in people with type 2 diabetes — David Kloecker ...
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Glycaemic control and diabetes-related health outcomes: longitudinal HbA1c trajectories, cumulative morbidity, and disease transitions in people with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-09
Organisations:
David Kloecker - Chief Investigator - Leicester Diabetes Centre
David Kloecker - Corresponding Applicant - Leicester Diabetes Centre
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
Primary (cardiovascular) outcomes: hospitalisation for heart failure and 3-point MACE (major adverse cardiovascular events) defined as nonfatal stroke, nonfatal myocardial infarction and cardiovascular death.
Secondary (non-cardiovascular) outcomes: non-cardiovascular death, all-cause death.
Description: Technical Summary
The current study will investigate the longitudinal relationship between HbA1c and complications and mortality, map out the natural history of macrovascular complications, and assess the impact of prior or repeated events on the risk of future events in patients with type 2 diabetes (T2DM). Using CPRD data linked to HES APC and ONS, we will investigate the association between repeated HbA1c measurements and diabetes-related complications (myocardial infarction, stroke, peripheral vascular disease, heart failure, chronic kidney disease) and mortality (all-cause and cause-specific mortality) in patients with T2DM using a joint modelling of longitudinal (i.e., HbA1c) and survival (i.e., time to complications) data in Stata and R {1, 2}. Key confounders of the associations, such as age, sex, ethnicity, glucose-lowering medications, and comorbidities at or before the diagnosis of T2DM will be accounted for while determining the relative and absolute risk of complications related to the longitudinal values of HbA1c. Furthermore, we will use repeated events analysis (recurrent events) and multistate models to describe the total burden of diabetes complications and the natural history of transitions across diabetes complications, respectively. Multi-state models permit estimation of state-specific hazards of such event to help predict risk of macrovascular complications in patients with different past histories of complications.
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Indirect acute effects of the COVID-19 pandemic on physical and psychological morbidity in the UK — Sinead Langan ...
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Indirect acute effects of the COVID-19 pandemic on physical and psychological morbidity in the UK
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Carstairs Index for 2011 Census (Excluding Northern Ireland)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-30
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amy Mulick - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - GSK
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sharon Cadogan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Diabetes mellitus emergency presentations: hyperglycaemia; hypoglycaemia, ketoacidosis; diabetic coma.
Mental health outcomes: anxiety; depression; eating disorders (anorexia; bulimia; others); fatal and non-fatal self-harm; obsessive-compulsive disorder (OCD); serious mental illness (i.e. schizophrenia, bipolar disorder and other psychoses).
Respiratory: asthma exacerbations; chronic obstructive pulmonary disease (COPD) exacerbations.
Cardiovascular: myocardial infarction; unstable angina; cardiac failure; transient ischaemic attacks; cerebrovascular accidents; venous thromboembolism (pulmonary embolism and deep venous thrombosis).
Alcohol: alcohol-related acute physical and psychological harms.Description: Technical Summary
The COVID-19 pandemic is an unprecedented public health crisis associated with very significant morbidity and mortality. Much of the clinical and research focus across the UK is understandably targeting pandemic management. As healthcare resources are reallocated to the COVID-19 response and modifications made to methods of care delivery due to social distancing requirements, there will inevitably be an impact on non-COVID-19 related healthcare provision, including activities designed to prevent people becoming ill, such as monitoring of chronic disease, potentially creating or worsening physical and mental health of patients.
We plan to analyse changes in disease incidence, routine monitoring and health outcomes, during and following the COVID-19 pandemic. The initial approach will be a descriptive before and after analysis. This will be followed by an interrupted time series analysis. This initial body of work focuses on acute presentations in the early stages of the pandemic. Our group is also planning a further large study focused on extending this to later outcomes related to the COVID-19 pandemic.
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Exploring patterns of healthcare resource utilisation and COPD exacerbations in patients with chronic obstructive pulmonary disease for health technology assessment — Daniel Prieto...
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Exploring patterns of healthcare resource utilisation and COPD exacerbations in patients with chronic obstructive pulmonary disease for health technology assessment
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-22
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Edward Burn - Corresponding Applicant - Oxford University Hospitals
Seamus Kent - Collaborator - National Institute for Health and Clinical Excellence - NICE
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
 Lung function
 Rate of COPD exacerbations
 Healthcare resource utilisation (including health and social care contacts, outpatient appointments, diagnostic and monitoring tests, A&E attendances, hospital admissions, and medications where possible)Description: Technical Summary
Health technology assessment (HTA) bodies (e.g. the National Institute for Health and Care Excellence (NICE) in England) make recommendations about the use of healthcare technologies in the health care system based on their clinical and cost-effectiveness. This is often done using health economic decision models, which are populated with data from various sources including observational databases. In chronic obstructive pulmonary disease (COPD) information is required on disease severity and progression, risks of COPD exacerbations, death, health-related quality of life, and healthcare resource utilisation.
We aim to use CPRD data to estimate some of these key parameters, namely the distribution of COPD patients by disease severity, rates of COPD exacerbations by disease severity, and healthcare utilisation and costs by both disease severity and history of exacerbations.
We will estimate these parameters using CPRD (GOLD) data that will be mapped to the Observational Medical Outcomes Partnership (OMOP) common data model. The common data model ensures that otherwise disparate datasets have the same structure and clinical coding languages (e.g. SNOMED for clinical terms and RxNorm for drugs). This increases the interoperability of data such that code developed on any one data set can be applied to others in the same format. This is important for HTA, because it allows parameters (e.g. healthcare costs) to be easily translated to different populations and settings.
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Which patients with visual impairment need to access Falls Services? Â Using big data to bridge the intervention gap — Darren Ashcroft ...
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Which patients with visual impairment need to access Falls Services? Â Using big data to bridge the intervention gap
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-21
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Jung-Yin Tsang - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Christine Dickinson - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Luke Munford - Collaborator - University of Manchester
Robert Harper - Collaborator - Manchester University NHS Foundation Trust (MFT)
Tjeerd van Staa - Collaborator - University of Manchester
Tom Blakeman - Collaborator - University of ManchesterOutcomes:
Primary outcome will be fractures (frequency and anatomical location).
Secondary outcomes include falls; fracture or fall related-hospitalisations; cause-specific mortality; costs of healthcare utilisation resulting from a fall in people with cataract, age related macular degeneration, and glaucoma.
Description: Technical Summary
Visual impairment (VI) has considerable resource implications for health services dealing with an ageing society. In particular, it is a major risk factor for falls, particularly affecting those over 65 years of age. Individuals with VI are 70% more likely to have a fall, with multiple falls occurring almost twice as often. Falls cause over 250,000 emergency hospital admissions per year and associated hip fractures alone costing the NHS over two billion pounds annually. For patients, this can result in life-limiting fractures, pain and distress, and the loss of independence. Three leading causes of age-related vision loss include cataract, age related macular degeneration (AMD) and glaucoma. Small studies show that over a third of those with cataracts will experience falls, and that people with glaucoma or AMD are three times more likely to fall compared to people without eye disease. Larger studies are required to understand this population, so that better targeted strategies can be developed for managing this vulnerable population and preventing falls. Using a large database of electronic health records Clinical Practice Research Datalink (CPRD GOLD and Aurum) with linked hospitalisation and mortality records, cohort studies will be performed between 2007-2019. First, a descriptive analysis of annual incidence rates of falls and fractures in patients will be outlined. Then retrospective cohort studies will be performed, comparing patients with these eye diseases to those without (matched by age, sex and general practice), using a Cox proportional hazards model to determine the risk of complications including falls, fractures, hospitalisation and death. Other factors that may moderate this risk will be explored as an interaction within these models, including medical comorbidity, medications that increase fall risk and polypharmacy. The costs to the NHS of treating these patients will also be calculated through monetarising all health care services used following a fall.
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Retrospective cohort study on first-time use of insulin detemir for diabetes type 2 glycaemic control in elderly and multimorbidity patients living in the United Kingdom — Uffe Christian Braae ...
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Retrospective cohort study on first-time use of insulin detemir for diabetes type 2 glycaemic control in elderly and multimorbidity patients living in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-07
Organisations:
Uffe Christian Braae - Chief Investigator - Novo Nordisk
Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Melanie Davies - Collaborator - University of Leicester
Renuka M - Collaborator - Novo Nordisk
Sophie BIROT - Collaborator - Novo NordiskOutcomes:
Glycaemic control; hypoglycaemia; oral glucose lowering drugs; adherence to treatment
Description: Technical Summary
This study aims to describe the change in HbA1c levels in T2DM patient groups such as elderly (?65) and patients with comorbidities such as cardiovascular, renal, or liver disease, after initiating insulin detemir. Furthermore, we will investigate the occurrence of hypoglycaemic events, change in the number of oral glucose lowering drugs used, and the adherence to insulin detemir among these patient groups. Insulin detemir has shown to be effective in controlling glycaemic levels in patients with T2DM. However, limited evidence is available describing the use in T2DM elderly patients and patients suffering from comorbidities such as cardiovascular/renal/hepatic impairment in a real-world setting. The study will use a retrospective cohort design, with first-time use of insulin detemir as index, to assess glycaemic control based on HbA1c prior to index and during a 12-month post-index follow-up period. Mixed model of repeated measures (MMRM) will be used to evaluate mean Hb1Ac levels from baseline to end of follow-up. The risk of hypoglycaemia will be evaluated based on number of events from index to 12-month follow-up and analysed using a negative binomial model. The adherence to insulin detemir will be described for the different patient groups by investigating at index to discontinuation insulin detemir usage using Cox proportional hazard regression.
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Primary care service use towards end of life among patients who died before and during the COVID-19 epidemic: a nationwide cohort study using the Clinical Practice Research DataLink — Wei Gao ...
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Primary care service use towards end of life among patients who died before and during the COVID-19 epidemic: a nationwide cohort study using the Clinical Practice Research DataLink
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-07-06
Organisations:
Wei Gao - Chief Investigator - King's College London (KCL)
Wei Gao - Corresponding Applicant - King's College London (KCL)
Emeka Chukwusa - Collaborator - King's College London (KCL)
Irene Higginson - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Stephen Barclay - Collaborator - University of CambridgeOutcomes:
GP consultation (primary); GP Prescription; GP Referral.
Description: Technical Summary
Background: the epidemic of coronavirus disease 2019 (COVID-19) has been causing a wide-spread disruption across all care settings including primary care since March 2020 in the United Kingdom. Primary care plays an important role in managing and coordinating the care for patients who are approaching the end of life. There is little data to understand how the COVID-19 epidemic influence these patients use of primary care services.
Aim: to evaluate and compare reasons for, patterns of and factors associated with the use of primary care services in patients who died before and during the COVID-19 epidemic.
Study design: a nationwide comparative cohort study.
Data and methods: the data source is the Clinical Practice Research DataLink. All patients who died before and during the COVID-19 epidemic since 01/01/2019 will be included. The outcomes to be measured: GP consultation (primary), GP prescription, and GP referral. Independent variables include patient socio-demographic and clinical characteristics, with palliative care needs recorded (1) or not (0), and practice-level characteristics. The outcome and independent variables as well as other details (e.g. type, location) on GP consultations will be described using descriptive statistics by the period of patients deaths (before & during). The factors associated with primary care service use will be identified using a generalised linear mixed model, accounting for the hierarchical structure of the data. We will also use a structural equation model/artificial neural network to explore how various factors interact with each other to affect primary care service use. The robustness of the findings will be assessed with sensitivity analysis. Bonferroni correction will be used to control for multiple testing.
Implications: the data generated in this study are key to understand care needs and service gaps, identify and monitor care inequality in primary care, maintain the quality of end-of-life care in current and future public health emergencies.
Source
2020 - 06
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Shaping and testing the GUIE dataset: Roma, Gypsy and Traveller children case study — unknown...
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Shaping and testing the GUIE dataset: Roma, Gypsy and Traveller children case study
Where: unstated
When: 2020-6-22
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to shape, test and demonstrate the value of the newly linked Growing Up in England (GUIE) Wave 1 dataset in addressing data gaps and building up new quantitative evidence. It will do this with a focus on Roma, Gypsy and Traveller (RGT) children and young people.
The GUIE datasetThe Office for National Statistics (ONS) has linked 2011 Census records to attainment data from a bespoke extract of Department for Education data named the All Education Dataset for England (AEDE) to create the GUIE dataset. This new data linkage will enable us to examine the educational progression of a cohort of children and young people who were aged 10 to 25 at the time of the 2011 Census. We will be able to follow the cohort of children up to academic year 2014/15 (when the children were ages 14 to 29) using the educational records included in the AEDE. In addition, we will be able to examine the previous educational records of the cohort going back to 2001/02. In an earlier âproof of conceptâ GUIE dataset, around two million records were matched. We will be using wave 1 of the GUIE dataset for our analysis which will include records from further education colleges as well as schools, producing a larger overall sample size for analysis.
Key questionsThe proposed project will explore the potential for using the GUIE dataset to build up a much-needed evidence base on the relationship between RGT childhood circumstances and experiences and their educational participation and progression, including within post-16 education.
There are three main objectives to this project:
To shape and develop the linkages of the GUIE dataset to maximise its potential for the analysis of the RGT group To test the GUIE dataset and evaluate its quality for the purposes of RGT analysis by providing feedback on unmatched cases To conduct initial analysis of the GUIE data with a view to demonstrating its value added in building up new evidence, knowledge and understanding of the RGT group. What is the potential impact of this work?A lack of robust data limits knowledge and understanding of the RGT community and is a barrier to effective policy interventions and, ultimately, to social change and equality. The proposed research will promote the public good by helping to build up quantitative evidence on the childhood circumstances and educational achievements and trajectories of children and young people from the RGT ethnic minority group, and by contributing to the evidence base for policymaking.
Amongst other early uses, the findings could feed into work being undertaken by the Childrenâs Commissionerâs Office on childhood vulnerability , work undertaken by the Ministry of Housing, Communities & Local Government (MHCLG) in building up its evidence base for the national strategy for tackling RGT inequalities. In addition, it could feed into work by the Race Disparity Unit in addressing a lack of RGT data and work undertaken by NGOs working with Roma, Gypsy and Travellers.
The research will address the conceptual and methodological challenges associated with tailoring and using the GUIE dataset for the analysis of the childhood circumstances and educational outcomes of RGT children and young people. The findings will add to a growing body of research that addresses the problem of âdata exclusionâ and âinvisibilityâ in social statistics, and which builds up quantitative evidence on disadvantaged and at-risk groups of children.
Project details Researchers include Polly Vizard and Polina Obolenskaya, Centre for Analysis of Social Exclusion (CASE), London School of Economics (LSE) Funded value: £168,234 Duration of project: 1 January 2021 â April 2022This project is funded via the ADR UK Strategic Hub Fund, a dedicated fund for commissioning research using newly linked administrative data, in consultation with the former Research Commissioning Board (RCB). Details of the funding grant awarded by ADR UK to UWE for this project can also be found on the UK Research and Innovation (UKRI) Gateway to Research platform.
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Shielded Patient List (SPL) (Identifiable) (Care and Support to Individual) — NHS Wales Informatics Service ...
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To enable Wales to identify those individuals, who could be consuming the available services provided by their primary care provider in their home country (England), but if they want to access food parcels, priority shopping slots and volunteer support from their local authority this would not necessarily be covered in the comms they receive, the key purpose of this dissemination is to identify those individuals for the purpose making that direct support available to the identified individuals. — IG-00517_2
Recipient Data Controller Organisation(s) : NHS Wales Informatics Service
Approval Date: 16/06/2020
Purpose for which the data is being used: To enable Wales to identify those individuals, who could be consuming the available services provided by their primary care provider in their home country (England), but if they want to access food parcels, priority shopping slots and volunteer support from their local authority this would not necessarily be covered in the comms they receive, the key purpose of this dissemination is to identify those individuals for the purpose making that direct support available to the identified individuals.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Care and Support to Individual
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: COPI Regulations
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â as the dissemination of data is for the purposes of providing care and support the patient in their country of residence, it is considered that the public interest overrides the NDOP.
Source -
Covid-19 Testing Results (Identifiable) (Secondary Uses) — Department of Health and Social Care...
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To support quality assurance and data reconciliation to ensure no clinical risk for subjects through not receiving test results. — IG-00688
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 04/06/2020
Purpose for which the data is being used: To support quality assurance and data reconciliation to ensure no clinical risk for subjects through not receiving test results.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: COPI Regulations 3(1) and 3(3)
Common Law Duty of Confidentiality: COPI Regulations 3(1) and 3(3)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Shielded Patient List (SPL) (Identifiable) (Care and Support to Individual) — NHS National Services Scotland...
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To enable Scotland to identify those individuals, who could be consuming the available services provided by their primary care provider in their home country (England), but if they want to access food parcels, priority shopping slots and volunteer support from their local authority this would not necessarily be covered in the comms they receive, the key purpose of this dissemination is to identify those individuals for the purpose making that direct support available to the identified individuals. — IG-00517_1
Recipient Data Controller Organisation(s) : NHS National Services Scotland
Approval Date: 05/06/2020
Purpose for which the data is being used: To enable Scotland to identify those individuals, who could be consuming the available services provided by their primary care provider in their home country (England), but if they want to access food parcels, priority shopping slots and volunteer support from their local authority this would not necessarily be covered in the comms they receive, the key purpose of this dissemination is to identify those individuals for the purpose making that direct support available to the identified individuals.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Care and Support to Individual
Statutory Authority: COPI Regulations 3(1) and 3(3) Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: COPI Regulations
GDPR and Data Protection Act 2018: GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: National Health Service (Functions of the Common Services Agency) (Scotland) Order 2008 section 2(f)
Common Law Duty of Confidentiality: Public Interest
GDPR and Data Protection Act 2018: GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(i) â Public health DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Not Applied â Public Interest.
Source -
Shielded Patient List (SPL) (Identifiable) (Direct Care) — Somerset NHS Foundation Trust ...
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In order to be able to proactively contact and support patients under their care, Mental Health, Learning Disability and Autism teams need to be able access their local Shielded Patient Lists so they can cross-check these lists by NHS number against their clinical systems in order to identify those patients under their care who are shielding. — IG-00492
Recipient Data Controller Organisation(s) : Somerset NHS Foundation Trust
Approval Date: 25/06/2020
Purpose for which the data is being used: In order to be able to proactively contact and support patients under their care, Mental Health, Learning Disability and Autism teams need to be able access their local Shielded Patient Lists so they can cross-check these lists by NHS number against their clinical systems in order to identify those patients under their care who are shielding.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice or Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice or Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Hospitalisation in England Surveillance System (CHESS) data
Intensive Care National Audit & Research Centre
(ICNARC) data
Hospital Episode Statistics (HES)
Emergency Care Data Set (ECDS) (Aggregate (small numbers not supressed)) (Secondary Uses) — Lancashire Teaching Hospitals NHS Foundation Trust...
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To enable accurate critical care capacity planning by NHS trusts during the Covid-19 pandemic. NHSE/I will use for regional and national based capacity planning. PHE will use the data for data quality reporting and publication of national statistics, in partnership with NHS Digital. — IG-00421_2
Recipient Data Controller Organisation(s) : Lancashire Teaching Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Cambridge University Hospitals NHS Trust Kings College Hospital NHS Foundation Trust NHS England and Improvement Public Health England
Approval Date: 04/06/2020
Purpose for which the data is being used: To enable accurate critical care capacity planning by NHS trusts during the Covid-19 pandemic. NHSE/I will use for regional and national based capacity planning. PHE will use the data for data quality reporting and publication of national statistics, in partnership with NHS Digital.
Dataset: Hospitalisation in England Surveillance System (CHESS) data Intensive Care National Audit & Research Centre (ICNARC) data Hospital Episode Statistics (HES) Emergency Care Data Set (ECDS)
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice â NHS Trusts, PHE & DHSC COPI Regulations 3(1) and 3(3) â NHSE/I
Common Law Duty of Confidentiality: General COPI Notice â NHS Trusts, PHE & DHSC COPI Regulations 3(1) and 3(3) â NHSE/I
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation - NHS Trusts, PHE & DHSC GDPR Article 6(1)(e) â Public task - NHSE/I GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
Shielded Patient List (SPL)
Second Generation Surveillance System (SGSS)
Covid-19 Testing Results (Aggregate (small numbers not supressed)) (Secondary Uses) — NHS England and Improvement ...
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For Covid-19 public health policy and planning purposes. — IG-00686
Recipient Data Controller Organisation(s) : NHS England and Improvement
Approval Date: 02/06/2020
Purpose for which the data is being used: For Covid-19 public health policy and planning purposes.
Dataset: Shielded Patient List (SPL) Second Generation Surveillance System (SGSS) Covid-19 Testing Results
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - this data is Aggregate data and is therefore not confidential data.
GDPR and Data Protection Act 2018: N/A â the disseminated data is not personal data under the GDPR
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - this data is Aggregate data and is therefore not confidential data.
GDPR and Data Protection Act 2018: N/A â the disseminated data is not personal data under the GDPR
National Data Opt-out Applied: Not Applied â the data is not patient identifiable.
Source -
COVID Care Home Testing Dataset (Aggregate (small numbers supressed)) (Secondary Uses) — Department of Health & Social Care (DHSC)...
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Analysis of the number of tests undertaken within care homes and the number of staff and residents within the care home that are tested. — IG-00590_2
Recipient Data Controller Organisation(s) : Department of Health & Social Care (DHSC)
Approval Date: 24/06/2020
Purpose for which the data is being used: Analysis of the number of tests undertaken within care homes and the number of staff and residents within the care home that are tested.
Dataset: COVID Care Home Testing Dataset
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
EPMA data for COVID-19 response (Anonymised ) (Secondary Uses) — NHS Hospitals in England...
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To enable hospitals to improve the quality of the data held in their EPMA (Electronic Prescribing and Medicines Administration) by adding the correct medication code. — IG-00305_1
Recipient Data Controller Organisation(s) : NHS Hospitals in England
Approval Date: 01/06/2020
Purpose for which the data is being used: To enable hospitals to improve the quality of the data held in their EPMA (Electronic Prescribing and Medicines Administration) by adding the correct medication code.
Dataset: EPMA data for COVID-19 response
Category of Data: Anonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: NHS Act 2006
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data.
Source -
Covid-19 Testing Results (Aggregate (small numbers not supressed)) (Secondary Uses) — Local Authorities...
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For Covid-19 public health policy and planning purposes. — IG-00637_1
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care NHS England
Approval Date: 04/06/2020
Purpose for which the data is being used: For Covid-19 public health policy and planning purposes.
Dataset: Covid-19 Testing Results
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data.
GDPR and Data Protection Act 2018: N/A â the disseminated data is not personal data under the GDPR
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - this data is Aggregate Data and is therefore not confidential data.
GDPR and Data Protection Act 2018: N/A â the disseminated data is not personal data under the GDPR
National Data Opt-out Applied: Not Applied â the data is not patient identifiable.
Source - and 30 more projects — click to show
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Shielded Patient List (SPL) (Aggregate (small numbers not supressed)) (Secondary Uses) — Local Authorities...
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To present regional and local data to allow for its use in public health and allow for greater analysis, modelling and planning to be performed to aid in the response to the pandemic. — IG-00613_1
Recipient Data Controller Organisation(s) : Local Authorities Department of Health and Social Care NHS England
Approval Date: 02/06/2020
Purpose for which the data is being used: To present regional and local data to allow for its use in public health and allow for greater analysis, modelling and planning to be performed to aid in the response to the pandemic.
Dataset: Shielded Patient List (SPL)
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(2)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data.
Source -
Covid-19 Testing Results (Identifiable) (Direct Care) — GP Practices ...
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Disseminated on behalf of DHSC for entry into GP patient records to enable GPs to view the Covid-19 test results. This will allow GPs to identify and understand information about patients with Covid-19, information about incidents of patient exposure to Covid-19 and the management of patients with or at risk of Covid-19 including: locating, contacting, screening, flagging and monitoring such patients and collecting information about and providing services in relation to testing. — IG-00616_1
Recipient Data Controller Organisation(s) : GP Practices
Approval Date: 16/06/2020
Purpose for which the data is being used: Disseminated on behalf of DHSC for entry into GP patient records to enable GPs to view the Covid-19 test results. This will allow GPs to identify and understand information about patients with Covid-19, information about incidents of patient exposure to Covid-19 and the management of patients with or at risk of Covid-19 including: locating, contacting, screening, flagging and monitoring such patients and collecting information about and providing services in relation to testing.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â Direct Care.
Source -
Shielded Patient List (SPL) (Identifiable) (Direct Care) — Redbridge CCG ...
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Managing the flow of shielding patients in emergency care services to reduce the risk of those patients being exposed to environments with a high risk of contracting COVID 19. — IG-00655
Recipient Data Controller Organisation(s) : Redbridge CCG
Approval Date: 17/06/2020
Purpose for which the data is being used: Managing the flow of shielding patients in emergency care services to reduce the risk of those patients being exposed to environments with a high risk of contracting COVID 19.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â legal obligation overrides.
Source -
COVID-19 SitReps (Aggregate (small numbers supressed)) (Secondary Uses) — NHS England and Improvement ...
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To support the operational planning and delivery of NHS services in response to COVID-19. — IG-00522
Recipient Data Controller Organisation(s) : NHS England and Improvement
Approval Date: 26/06/2020
Purpose for which the data is being used: To support the operational planning and delivery of NHS services in response to COVID-19.
Dataset: COVID-19 SitReps
Category of Data: Aggregate (small numbers supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 S261(5)(d)
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous data
Source -
Fluoroquinolones and the risk of retinal detachment, uveitis, peripheral neuropathy, and hospitalisation with aortic aneurysm or dissection — Ian Douglas ...
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Fluoroquinolones and the risk of retinal detachment, uveitis, peripheral neuropathy, and hospitalisation with aortic aneurysm or dissection
Datasets:GP data, HES Admitted Patient Care; Patient Level Carstairs Index for 2011 Census; Practice Level Carstairs Index for 2011 Census (Excluding Northern Ireland)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-21
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeremy Brown - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Clémence Leyrat - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
David Yorston - Collaborator - Tennent Institute of Ophthalmology
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nicholas Galwey - Collaborator - GSK
Patrick Batty - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Stephen Evans - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Retinal detachment; Uveitis; Peripheral neuropathy; Hospitalisation with aortic aneurysm or dissection; Tendon rupture (positive control outcome).
Description: Technical Summary
Fluoroquinolones have been associated with a number of adverse events including retinal detachment, uveitis, peripheral neuropathy, and aortic aneurysm or dissection. It is possible, however, that some of these associations are not causal but due to confounding. We will investigate these associations using both a cohort study design and two self-controlled study designs, namely the case-time-control study and the self-controlled case series.
We will use a cohort study of people prescribed fluoroquinolones or an alternative antibiotic class prescribed for similar indications, cephalosporin, to estimate the risk of uveitis, peripheral neuropathy, and hospitalisation with aortic aneurysm or dissection, associated with fluoroquinolone prescription. We will include a positive control outcome, tendon rupture, which has a well-established association with fluoroquinolones.
Propensity scores, calculated using logistic regression, will be used in this cohort study to adjust for measured covariates. Propensity score weighted Cox regression will be used to estimate the association of each outcome with fluoroquinolone exposure.
For retinal detachment and uveitis, self-controlled case series will be conducted to estimate the risk of these outcomes with fluoroquinolone prescription and with the control antibiotic exposures of cephalosporin, trimethoprim and co-amoxiclav. For hospitalisation with aortic aneurysm or dissection, a case-time-control study will be conducted to estimate the risk of hospitalisation with this outcome associated with fluoroquinolone prescription and associated with the control antibiotics cephalosporin, trimethoprim and co-amoxiclav. Both the self-controlled case series and the case-time-control study eliminate time-invariant confounding by design. However, time-varying confounding relating to the infection may be present, which we would detect from elevated risk observed with the control antibiotics.
We will also use quantitative bias analysis methods to assess the extent to which findings could be biased by residual confounding.
Source -
Retrospective cohort study to estimate age-stratified cardio-respiratory and exacerbations of diabetes outcome rates to support influenza vaccine rVE study planning in Europe — Rebecca Ghosh ...
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Retrospective cohort study to estimate age-stratified cardio-respiratory and exacerbations of diabetes outcome rates to support influenza vaccine rVE study planning in Europe
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-08
Organisations:
Rebecca Ghosh - Chief Investigator - CPRD
Rebecca Ghosh - Corresponding Applicant - CPRD
Achim Wolf - Collaborator - CPRD
Daniel Modin - Collaborator - University of Copenhagen
Deborah Rudin - Collaborator - Sanofi Pasteur SA
Eleanor Yelland - Collaborator - CPRD
Helen Booth - Collaborator - CPRD
Helene Bricout - Collaborator - Sanofi Pasteur MSD ( closed )
Hilary Shepherd - Collaborator - CPRD
Joshua Nealon - Collaborator - Sanofi Pasteur SA
Rachael Williams - Collaborator - CPRD
Sandra Chaves - Collaborator - Sanofi Pasteur SA
Tor Biering-Sorensen - Collaborator - University of CopenhagenOutcomes:
Primary care, hospitalisation and mortality events for:
- Cardio-Vascular: cardiac [total]
Sub-groups: Hypertensive heart disease; Hypertensive heart and renal disease; Myocardial infarction; Subsequent myocardial infarction; Ischaemic cardiomyopathy; Acute pericarditis; Other diseases of pericardium; Acute and subacute endocarditis; Endocarditis and heart valve disorders in diseases classified elsewhere; Acute myocarditis; Myocarditis in diseases classified elsewhere; Cardiomyopathy; Cardiac arrest; Heart failure- Cardio-Vascular: vascular [total]
Sub-groups: Subarachnoid haemorrhage; Intracerebral haemorrhage; Other nontraumatic intracranial haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction; Occlusion and stenosis of precerebral arteries, not resulting in cerebral infarction; Occlusion and stenosis of cerebral arteries, not resulting in cerebral infarction; Other cerebrovascular diseases; Cerebrovascular disorders in diseases classified elsewhere; Sequelae of cerebrovascular disease- Cardio-Vascular: arrythmia [total]
Sub-groups: Atrial fibrillation and flutter; Other cardiac arrhythmias- Respiratory [total]
Sub-groups: Influenza and pneumonia; Unspecified chronic bronchitis; Emphysema; Other chronic obstructive pulmonary disease; Asthma; Respiratory failure, not elsewhere classified- Diabetic exacerbations [total]
Sub-groups: Type 1 diabetes mellitus with ketoacidosis or coma; Type 2 diabetes mellitus with ketoacidosis or coma; Malnutrition-related diabetes with ketoacidosis mellitus or coma; Other specified diabetes mellitus with ketoacidosis or coma; Unspecified diabetes mellitus with ketoacidosis or coma; Other hypoglycaemia
Hypoglycaemia, unspecified; Abnormal glucose tolerance testAll-cause mortality
All-cause hospitalisationDescription: Technical Summary
Background and rationale:
Associations between seasonal influenza and cardio-respiratory and exacerbations of diabetes events (CRD) have been observed. Currently the data needed to determine whether new influenza vaccines are cost-effective is lacking. Data are needed to better understand the burden of disease which could be prevented by influenza vaccination as well as to plan clinical studies, and particularly their sample sizes.Objectives:
Describe the demographics of the adult study population by age, high-risk for influenza conditions and influenza vaccination status
Determine the age-stratified incidence rate of CRD events during and outside influenza season and stratify by:
- other specified high-risk groups,
- seasonality,
- "cardiovascular", "respiratory" or "diabetic" cause
Apply an excess modelling approach to estimate the influenza-attributable proportion of these cases and deathsMethods:
In this retrospective longitudinal observational cohort study CRD events in England will be described in primary care (CPRD GOLD and CPRD Aurum), secondary care (HES APC), both combined and with deaths from ONS mortality data. The study period is from 2010/11 to 2019/20 with events described as age-stratified incidence rates for each influenza season (1st December to 31st May). Individuals must be aged >/=18 on the first day of each influenza season and will be defined in primary care using READ and SNOMED codes and in secondary care and ONS mortality using ICD10 "I", "J" or "E" codes. The population at risk will be estimated as the CPRD population on the 1st of January at the mid-point of each influenza season (1st December to 31st May the following year). Excess event modelling will be conducted using a modified Serfling-Poisson statistical regression model which uses influenza data as an exposure, after controlling for seasonal and other confounders.
Source -
A cohort study examining access to NHS weight management services using routine data from primary and secondary care — Karen Coulman ...
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A cohort study examining access to NHS weight management services using routine data from primary and secondary care
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-25
Organisations:
Karen Coulman - Chief Investigator - University of Bristol
Karen Coulman - Corresponding Applicant - University of Bristol
Amanda Owen-Smith - Collaborator - University of Bristol
Andrew Judge - Collaborator - University of Oxford
Helen Parretti - Collaborator - University of East Anglia
Jane Blazeby - Collaborator - University of Bristol
John Macleod - Collaborator - University of Bristol
Richard Welbourn - Collaborator - NHS England
Ruta Margelyte - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of Bristol
Tim Jones - Collaborator - University of BristolOutcomes:
a) Referral to weight management services (primary care-based or hospital-based)
b) Undergoing bariatric surgeryDescription: Technical Summary
Aims and Objectives
This study aims to describe the characteristics of people with overweight and obesity in England who are eligible for NHS weight management (WM) services including bariatric surgery, according to national guidance, and determine predictors of access to these services. We will also investigate trends in bariatric surgery before and after the transfer of commissioning responsibility from NHS England to Clinical Commissioning Groups in April 2017.Exposures and Outcomes
The primary exposure is people with a diagnosis of overweight and obesity in England during the study period (January 2007-latest CPRD update), and the outcomes are a) referral to NHS WM services and b) undergoing NHS bariatric surgery.Methods
This study includes both descriptive and hypothesis-testing elements using retrospective cohort and cross-sectional designs. Hospital Episode Statistics (HES) will be used to cross-check bariatric surgery recorded in CPRD.Data analyses
Descriptive statistics will summarise demographic and clinical characteristics of the overall study cohort. The provision to need ratios for outcomes a) and b) will be descriptively calculated (number within the cohort with each outcome compared with the total number eligible for these services according to national guidance), and stratified by demographic and clinical characteristics. Proportions and Confidence Intervals will be calculated using a Poisson model. Cox regression will estimate time to event data including predictors for both outcomes a) and b). An interrupted time series approach will investigate the trend in bariatric surgery levels before and after the transfer of commissioning responsibility. Segmented linear regression will estimate changes in levels and trends after the transfer. Cox regression will be repeated on two separate cohorts of patients  a pre-intervention and post-intervention cohort.
Source -
Evaluation of the drivers in heterogeneity in unplanned hospital admissions and mortality in frail and multimorbidity elderly patients before and during/after COVID-19 — Tjeerd van Staa ...
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Evaluation of the drivers in heterogeneity in unplanned hospital admissions and mortality in frail and multimorbidity elderly patients before and during/after COVID-19
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-30
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Victoria Palin - Corresponding Applicant - University of Manchester
Alexander Pate - Collaborator - University of Manchester
Ali Fahmi - Collaborator - University of Manchester
Andrew Clegg - Collaborator - University of Leeds
Benjamin Brown - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Ghita Berrada - Collaborator - University of Manchester
Iain Buchan - Collaborator - University of Manchester
Munir Pirmohamed - Collaborator - University of Liverpool
Xiaomin Zhong - Collaborator - University of Manchester
Ya-Ting Yang - Collaborator - University of ManchesterOutcomes:
- all-cause mortality
- emergency hospital admissions
- infection-related complications
- Accident and Emergency Attendance
- care home admission
The primary outcomes of interest will be all-cause mortality as recorded in the GP EHRs (Hippisley-Cox & Coupland, 2017), emergency hospital admissions as recorded in the Hospital Episode Statistics (HES) and, for the frail multimorbid antibiotic cohort, infection-related complications. All-cause mortality will be based on the death recording in the GP EHRs (with sensitivity analyses conducted with death certificate records, where available). The definition for emergency hospital admissions will be similar to that used for the prediction tool QAdmissions (Hippisley-Cox & Coupland, 2013). The emergency admission information will be derived from the method of admission field recorded for each hospitalisation including code 21 (accident and emergency), 22 (GP direct to hospital), 23 (GP via a bed bureau); 24 (consultant clinic), 25 (mental health crisis resolution team), and 28 (other means). Only emergency admissions where the admission date and discharge date were both recorded and where the admission date was on or before the discharge date will be included (Hippisley-Cox & Coupland, 2013). The definition for infection-related complications will be similar as used in previous studies, including infection-related hospital admissions as recorded in HES and GP-recorded complications (Mistry et al., 2020; Van Staa et al., 2020). Secondary outcomes of interest will include Accident and Emergency Attendance, care home admission (as recorded in the GP EHRs) and the distribution of admission and discharge ICD diagnoses as recorded in HES.Description: Technical Summary
Recent research in primary care found that 23·2% of the total population were multimorbid (i.e., were suffering from two or more long-term disorders). There are concerns in primary care about what we can do for the most vulnerable patients in the post Covid-19 world and what interventions should be prioritised in order to help these patients. The overall objective of this study is to identify opportunities to better target clinical improvement activities for frail multimorbid elderly patients and to evaluate the extent of variability in clinical outcomes and treatments and its predictors before and during/after Covid-19. The design will be a cohort study with nested case-control study. The main study population will be patients in participating practices who are 65 years or older and have electronic frailty index score of 0.21. The outcomes of interest will be death (irrespective of the cause), emergency hospital admissions (and reasons), infection-related complications, Accident and Emergency Attendance and care home admission. Indicators of type of clinical care and clinical measurements will be considered as modifiable predictors. A broad set of modifiable predictors will be evaluated in the development cohort and tested in the validation cohort (using Cox proportional hazards models). This will then be followed by expert review for clinically important predictors. The variables will include characteristics such as extent and type of polypharmacy, STOPP criteria (which concern potentially inappropriate prescribing or omissions) and medication regimen complexity index. propensity-matched case-control datasets will be used to identify the predictors that are associated with increased or decreased risks of the outcome of interest. The results of this study will be used to provide feedback to GPs (using a secure internet infrastructure) which can help to identify opportunities to better target clinical improvement activities to frail patients in their practice.
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Risk factors for and long-term outcomes in people with covid-19 admitted to hospital in England — Jennifer Quint ...
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Risk factors for and long-term outcomes in people with covid-19 admitted to hospital in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-08
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
David Coggon - Collaborator - University of Southampton
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Britton - Collaborator - University of Nottingham
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nicholas Hopkinson - Collaborator - Imperial College London
Paul Cullinan - Collaborator - Imperial College LondonOutcomes:
In the case-control study, the main outcome will be admission to hospital for, or death from, covid-19 infection. Within this, a sub-set of more severe disease will be defined by admission to an intensive care unit and/or death from the disease.
For the cohort study, the exact specification of outcomes for analysis will depend on their frequency in the cohort as a whole (covid-19 patients and controls) at the time, and on the scientific evidence that has by then emerged regarding possible long-term effects of infection (which will be monitored continually over the follow-up period). To the extent that numbers are sufficient for meaningful statistical analysis, they will include measures of:
- Cumulative incidence of recurrent/new covid-19 infection (confirmed by serology or probable from clinical presentation) classified according to severity (e.g. leading to hospital admission, admission to intensive care or death)
- New or exacerbated cardio-respiratory disease
- New or exacerbated renal disease
- New or exacerbated auto-immune disease
- Cumulative frequency of respiratory infections other than serologically confirmed/probable Covid-19 infection
- Cumulative frequency of non-respiratory infections
- New or exacerbated mental illnessDescription: Technical Summary
Evidence from around the globe indicates that most people infected by covid-19 will have only mild illness, but in approximately 20% of cases, the disease is more severe, requiring hospital admission. Among those admitted to hospital, ~1 in 4 require intensive care/and or die. Others may die from covid-19 without being admitted to hospital. To inform preventive strategies, there is a need to understand better what determines vulnerability to more severe illness, and to what extent. It is currently not clear if there are avoidable risk factors for admission, severe disease and/or death. For example, early papers suggest a low representation of smokers among those admitted, which is unexpected, but greater risk of severe disease. This information might allow modification of some factors that increase vulnerability, and help to work out those who could benefit most from shielding. In addition, it is important to find out whether people who recover from such illness incur an increased long-term risk of cardio-respiratory morbidity or of other types of illness.
To explore risk factors for hospital admission for covid-19, we will undertake a case control study using CPRD Gold and Aurum primary care data linked with HES inpatient data and ONS mortality data. Cases will be those individuals admitted to hospital with covid-19 and/or dying from the disease, with 5 controls per case matched on GP practice, sex and age. Using conditional logistic regression, we will investigate potential risk factors such as smoking, pre-existing conditions and medication.
To explore long-term health risks following hospital admission for covid-19, we will then follow up the cases and controls as a cohort, and use conditional Poisson regression to determine whether or not the cases have higher subsequent risk of deterioration in pre-existing disease or development of new cardiovascular, respiratory or other morbidity (e.g. heart failure, obstructive lung disease, mental health problems). The first analysis of outcomes will be at least 12 months after entry to follow-up.
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Exploring the role of electronic Frailty Index (eFI) using routine primary care electronic health care records data to predict hospitalization and mortality in older patients with type 2 diabetes — Iskandar Idris ...
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Exploring the role of electronic Frailty Index (eFI) using routine primary care electronic health care records data to predict hospitalization and mortality in older patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-08
Organisations:
Iskandar Idris - Chief Investigator - University of Nottingham
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Adam Gordon - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Thomas Crabtree - Collaborator - University of NottinghamOutcomes:
Composite of All-cause hospitalisation and All-cause mortality deriving from GP or HES data.
Description: Technical Summary
The technical summary should provide a succinct overview of the overarching study aim and objectives, primary exposure(s), and outcome(s), if relevant, study design, and methods including the main statistical tests to be used.
Type 2 diabetes (T2D) is an age related disease and the heterogeneity in older patients health status represent a challenge to making generalised treatment recommendations for older adults. The recent development and validation of an electronic frailty index (eFI) now offers a tool which was supported in the 2016 UK NICE multimorbidity guidelines. In this study, our research question is: Can an eFI, generated from routinely collected data, be used to predict hospitalization and mortality at an individual level of older patients with T2D?
Study design: an open cohort of patients 65 years and older, diagnosed with type 2 diabetes, followed for two years or until all-cause hospitalisation or mortality.
Methods: Multivariate Cox regression analysis will be run to predict the outcome. Model 1 will include social history, polypharmacy and the co-morbidity relevant to risk factor for hospitalization and mortality but not the eFI; Model 2 will be the same but will include the eFI. Likelihood-ratio test will be used to assess the effect of adding the eFI to the model. For both models, D statistics and Harrell's C statistics will be calculated as measures of discrimination. The addition of the eFI will be considered an improvement if a reduction in Akaike's Information Criterion is greater than 4.
The analysis will be repeated for patients grouped by different levels of glycaemic control. The groups will be formed by using quintiles of HbA1c at the study entry.
We believe findings from this study will form the basis for a wider, routine, evidence-based use of eFI when assessing and setting treatment targets for people with T2D, and will have a major impact on the quality of life of patients and in reducing the societal economic burden of treatments.
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Evaluating the health impact of familial hypercholesterolaemia in primary care patients compared with an intensively managed specialist disease registry — Barbara Iyen ...
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Evaluating the health impact of familial hypercholesterolaemia in primary care patients compared with an intensively managed specialist disease registry
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-15
Organisations:
Barbara Iyen - Chief Investigator - University of Nottingham
Barbara Iyen - Corresponding Applicant - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of NottinghamOutcomes:
- Incidence of cardiovascular disease
- Statin-prescribing rates
- Coronary revascularisation
- Change in LDL-cholesterol, 12 months after initiation of statins
- Cardiovascular mortality and all-cause mortality ratesDescription: Technical Summary
Background: Early identification and treatment of familial hypercholesterolaemia (FH) can reduce the risk of premature heart disease and death. Current evidence suggests that individuals with a diagnosis of FH in primary care have a 2-fold higher risk of coronary heart disease (CHD) than individuals without FH. It is unknown whether there are significant gaps in treatment and clinical outcomes between individuals with a diagnosis of FH in primary care, and those who have been referred to lipid clinics and under specialist management.
Aim: To explore the difference in clinical management, cardiovascular health and mortality outcomes in individuals with FH in primary care compared with FH patients in the Simon Broome FH register.
Study design: Observational cohort study
Settings:
a. General practices in England providing data to the CPRD database
b. Lipid clinics in England which contribute data to the Simon-Broome FH registerStudy population:
a. CPRD population: Individuals aged 18 to 80 years, documented FH diagnosis and registered at the general practice for at least a year after the earliest date that the practice started contributing quality-assured data to CPRD.
b. Simon-Broome study population: FH patients aged 18 to 80 years.Main outcome measures:
Primary outcomes: cardiovascular disease (defined as composite of CHD, stroke, transient ischaemic attack, peripheral vascular disease); statin-prescribing rates, coronary revascularisation interventionsSecondary outcomes: Low-density-lipoprotein (LDL) cholesterol response to statins, cardiovascular death, all-cause mortality
Statistical analyses:
- Survival analyses to determine the incidence rates of cardiovascular disease (CVD), cardiovascular-mortality and all-cause mortality in both FH cohorts.
- Assessment of statin prescribing rates, and proportion of FH patients in primary care, who attain the treatment goal of 50% LDL-cholesterol reduction, 12 months after initiating statins
- Multivariate Cox regression analyses to estimate the hazards ratios of CVD and mortality: (a) associated with LDL-cholesterol treatment response and (b) associated with coronary-revascularisation interventions.
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Developing the optimum strategy for coeliac disease case finding in adults and children — Penny Whiting ...
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Developing the optimum strategy for coeliac disease case finding in adults and children
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-07
Organisations:
Penny Whiting - Chief Investigator - University of Bristol
Martha Elwenspoek - Corresponding Applicant - University of Bristol
Alastair Hay - Collaborator - University of Bristol
Edna Keeney - Collaborator - University of Bristol
Gerry Robins - Collaborator - York Teaching Hospital NHS Foundation Trust
Hayley Jones - Collaborator - University of Bristol
Hazel Everitt - Collaborator - University of Southampton
Howard Thom - Collaborator - University of Bristol
Jessica Watson - Collaborator - University of Bristol
Joni Jackson - Collaborator - University of Bristol
Peter Gillett - Collaborator - NHS Scotland
Rachel O'Donnell - Collaborator - University of Bristol
Susan Mallett - Collaborator - University of BirminghamOutcomes:
Prediction modelling (case control) and validation of existing prediction models: the primary outcome is diagnosed CD (see Appendix A for Read codes).
Estimating risk of adverse long-term outcomes associated with CD and adverse events associated with biopsy (cohort): key outcomes are all-cause mortality; any malignancy; Hodgkin-lymphoma; non-Hodgkin-lymphoma; small intestinal cancer; colon cancer; splenic hypofunction; osteoporosis; iron deficiency anaemia; vitamin B12 and folate deficiency anaemia; pregnancy-related complications, including unexplained infertility, recurrent miscarriage or intrauterine growth restriction (see Appendix B for ICD-10 codes); and perforation, infection, bleeding, sepsis, myocardial infarction, and death associated with biopsy (see Appendix C for ICD-10 and Read codes).
Estimating medical costs associated with CD: key outcomes are number of primary care consultations, tests, referrals to out-patient hospital care and prescriptions.
Description: Technical Summary
Coeliac disease (CD) is an immune-mediated disorder, triggered by the protein gluten, estimated to affect 1% of the UK population. Some patients with CD may be asymptomatic, others present with non-specific symptoms, making diagnosis difficult; only 24% are thought to be diagnosed. Untreated CD may lead to malnutrition, anaemia, osteoporosis, infertility in women, lymphoma, and small bowel cancer.
Guidelines recommend that adults and children Âat high risk of CD should be offered testing. However, it is not clear which groups are at sufficiently high risk to justify routine testing, which symptoms should prompt testing, which tests should be offered, and whether confirmatory biopsy is necessary.
We are currently conducting a systematic review on the accuracy of diagnostic indicators (such as risk factors and symptoms) for CD. Diagnostic indicators that are associated with an increased risk of CD will be selected to inform the development of prediction models using CPRD GOLD data. We will fit logistic regression models with CD as the outcome and multiple predictors. From the results, we will produce estimates of the probability of CD diagnosis for each combination of diagnostic indicators available. We will validate the model developed in CPRD GOLD using bootstrapping (internal validation) and in CPRD Aurum (external validation). We will also validate any existing prediction model identified by the systematic review in CPRD Aurum.
Finally, the cost-effectiveness of CD testing of patients with pre-test probabilities of CD above certain thresholds will be evaluated with a long-term economic model. We will use CPRD Aurum linked to HES to estimate the risks of adverse outcomes in patients with CD (such as lymphoma or infertility) and the risk of adverse events, including death, associated with biopsy. These estimates will directly inform the economic model.
We will also use CPRD GOLD data to quantify medical costs associated with a diagnosis of coeliac disease. These estimates will directly inform the economic model.
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Risk factors and outcomes of COVID-19 in individuals with Down syndrome — Andre Strydom ...
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Risk factors and outcomes of COVID-19 in individuals with Down syndrome
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-17
Organisations:
Andre Strydom - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Asaad Baksh - Collaborator - King's College London (KCL)Outcomes:
Flu-like illness/ influenza, respiratory infections, COVID-19 suspected or confirmed diagnosis, cause-specific and all-cause mortality rates
Description: Technical Summary
Our overarching hypothesis is that DS individuals may be more vulnerable to developing COVID-19 which is not solely explained by co-occurrence of intellectual disability, and that they may also have worse outcomes following infection.
Objectives:
We will include individuals with Down syndrome in the CPRD datasets (GOLD, and Aurum) and 1) define their typical seasonal incidence for influenza/ flu and respiratory infection diagnosis and cause-specific as well as all-cause mortality rates to generate expected rates, 2) describe excess flu-like and respiratory infections and mortality as well as suspected, clinically-diagnosed or confirmed COVID-19 diagnoses during the COVID-19 pandemic in comparison with their peers with intellectual disabilities and general population, 3) explore and compare factors associated with excess infections during the COVID-19 pandemic, and 4) compare the treatment/ interventions offered and associated outcomes (e.g. hospitalisation/ death/ discharge/ recovery) and factors associated with poor outcome for those diagnosed with COVID-19.
Methods:
We will select a cohort of individuals with DS from CPRD and conduct an interrupted time series analysis, of individuals with Down syndrome compared to individuals from the general population, and those who have intellectual disabilities but not Down syndrome, to explore influenza/ seasonal flu, respiratory infection and COVID-19 diagnoses as well as mortality.
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The Burden of Illness of Human Health Outcomes Arising from Human-Animal Interactions — Alex Cook ...
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The Burden of Illness of Human Health Outcomes Arising from Human-Animal Interactions
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-15
Organisations:
Alex Cook - Chief Investigator - University of Surrey
Georgina Cherry - Corresponding Applicant - University of Surrey
Andrew Hancock - Collaborator - Zoetis Inc.
Chris D Poole - Collaborator - Digital Health Labs Limited
Isaac Odeyemi - Collaborator - Zoetis Inc.
James Frost - Collaborator - Digital Health Labs LimitedOutcomes:
Zoonoses incidence (disaggregated) | Charlson Co-morbidity Index | all-cause mortality | healthcare resource use expressed as nor only rate but also cost for each of: GP consultation | other primary care consultations | hospital admissions | A&E attendance | outpatient referral
Description: Technical Summary
The health of animals and people are interconnected and interdependent, a fact increasingly recognised by global organisations concerned with human health and animal health alike and one that has been brought into sharp relief in recent months with the emergence of the COVID-19 pandemic. Sixty percent of infectious diseases in humans are zoonotic, but despite their combined prevalence and statutory reporting in the UK, most zoonoses are poorly studied, having featured in none of the human research studies approved by CPRD since September 2015.
Therefore, the overarching aim of this study is to characterise the burden of human illness associated with a wide range of zoonotic diseases.
The proposed study has the following objectives: 1) chart secular trends in the epidemiology of individual zoonotic diseases (primary); 2) describe phenotypic characteristics for susceptibility to individual zoonotic diseases; 3) characterise acute and chronic co-morbidities following manifestation and diagnosis of zoonotic diseases; 4) enumerate not only excess mortality associated with the natural history of zoonotic diseases; but also 5) excess health resource use associated with the natural history of zoonotic diseases.
This matched cohort study will utilise both the CPRD GOLD & Aurum datasets as well as linked HES, ONS Mortality, and Deprivation data. The primary exposures are a diagnosis of the notifiable zoonotic diseases recorded in either primary or secondary care; of which at least a million cases are estimated. The principal outcomes are age-sex adjusted co-morbidity, adjusted all-cause mortality, and adjusted health resource use (rates & cost) consisting of GP consultation, other primary care consultation, all-cause hospital admission, A&E attendance, and outpatient referral. Differences in event rates for the outcomes of interest between cases and matched controls will be assessed by multivariate Poisson regression, while healthcare cost differences will be tested with generalised linear modelling with appropriate distribution and link functions.
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Risk of major adverse cardiac events in atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease - risk equivalent and familial hypercholesterolaemia patients with elevated low-density lipoprotein cholesterol — Christopher Morgan ...
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Risk of major adverse cardiac events in atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease - risk equivalent and familial hypercholesterolaemia patients with elevated low-density lipoprotein cholesterol
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-22
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Adeline Durand - Collaborator - Novartis UK
David Trueman - Collaborator - Source Health Economics
Raquel Lahoz - Collaborator - NOVARTISOutcomes:
Revascularization; Unstable angina; Non-fatal myocardial infarction; Non-fatal stroke; Cardiovascular death; Non-cardiovascular death.
Description: Technical Summary
Low density lipoprotein cholesterol (LDL-C) has been strongly associated with cardiovascular disease and coronary heart disease risk. Clinical trials have demonstrated that reducing LDL-C with pharmaceutical interventions such as statins has been shown to be associated with reduced incidence of atherosclerotic cardiovascular disease (ASCVD). However, a large proportion of patients with elevated LDL-C have been shown to be refractory to conventional cholesterol lowering regimens. Patients with familial hypercholesterolemia are particularly difficult to manage due to genetically high baseline LDL-C levels. Inclisiran is a subcutaneously delivered therapy that has been shown in clinical trials to reduce refractory LDL-C in patients with atherosclerotic cardiovascular disease and familial hypercholesterolaemia. Novartis are interested in understanding these populations in terms of demography, comorbidity and risk of cardiovascular risk. In this study we wish to conduct a non-interventional, non-comparative, retrospective study using the Clinical Practice Research Datalink (CPRD). We will also use linked data from the Hospital Episode Statistics admitted patient care dataset to ascertain both exposures and outcomes. Three cohorts of patients with elevated LDL-C will be selected, those with either i) familial hypercholesterolemia, ii) history of atherosclerotic cardiovascular disease (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or iii) atherosclerotic cardiovascular risk equivalent based on either comorbidity (type II diabetes or familial hypercholesterolemia) or Framingham score >20. These cohorts will not be mutually exclusive. We then wish to describe these cohorts in terms of demographics, cardiovascular and non-cardiovascular comorbidity, baseline biochemistry and baseline therapy profile. Crude rates of mortality, major adverse cardiovascular events (MACE) will be calculated by person year at risk and stratified by age, gender and baseline LDL-C category. A multi-state parametric model will then be constructed to estimate the transition probabilities between different disease states relating to MACE and non-cardiovascular mortality.
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Exacerbations and their Outcomes (EXACOS): Understanding the pathway to exacerbations of COPD and the association between frequency of exacerbations and risk of clinical and health-care utilization outcomes — Hana Mullerova ...
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Exacerbations and their Outcomes (EXACOS): Understanding the pathway to exacerbations of COPD and the association between frequency of exacerbations and risk of clinical and health-care utilization outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-07
Organisations:
Hana Mullerova - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Enrico de Nigris - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Annalisa Rubino - Collaborator - Evidera, Inc
Divyansh Srivastava - Collaborator - ZS Associates
Eleni Rapsomaniki - Collaborator - Astra Zeneca Ltd - UK Headquarters
Jennifer Quint - Collaborator - Imperial College London
John Bell - Collaborator - Astra Zeneca Ltd - UK Headquarters
Keith Peres da Costa - Collaborator - ZS Associates
Precil Varghese - Collaborator - Astra Zeneca Inc - USA
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK Headquarters
Vasanth Radhakrishnan - Collaborator - ZS AssociatesOutcomes:
In order to fully describe AECOPDs, their pathways and their impact in disease progression, clinical burden, and healthcare costs the following outcomes will be measured:
1) Future AECOPD events relative to previous AECOPDs (including previous LRTI).
2) Clinical burden defined as mortality rate (all cause, COPD related, and CVD related), change in lung function (FEV1), and if data allow change in breathlessness on exercise (mMRC).
3) Health care utilisation burden will be defined accounting for:
-number of GP consultations
-number of A&E visits
-number of outpatient visits
-number and length of hospitalisations
-number and length of ICU episodes (as far as possible)
-number of COPD maintenance prescriptions in the first year
-number of rescue packs prescribed (OCS +/- abx)With the exception of prescriptions, which will be limited to COPD treatment, these measures will be estimated for both COPD related and all-cause. These outcomes will be measured in a prevalent or incident COPD cohort depending on the objective. These outcomes will be used for specific aims outlined in detail in section E. These outcomes will be measured in a prevalent or incident COPD cohort depending on the objective.
Description: Technical Summary
Acute exacerbations of COPD (AECOPD) are common in patients with Chronic Obstructive Pulmonary Disease (COPD). Whilst approximately half of patients do not experience any AECOPD many patients experience many over the course of their disease. Previous studies have shown that a single AECOPD increases the risk of future multiple AECOPD. No studies have investigated the relationship between multiple AECOPD and risk of future AECOPD in this population. In addition, no studies have described the pathway of AECOPD from before COPD diagnosis to after diagnosis in order to understand the progression of AECOPD in COPD. Identifying the pattern of AECOPD across COPD progression is important in order to better identify patients who are at a higher risk of frequent AECOPD and who can be treated more efficiently. The first aim of this study is to understand the frequency of AECOPD in a COPD population and how they are related to future AECOPD, clinical burden, and health care utilization. The second aim of this study is to understand the pathway of AECOPD in newly diagnosed COPD patients and how this related to clinical burden and health care utilization.
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International trends in dual antiplatelet therapy among PCI-treated STEMI and NSTEMI patients: Pendant study in the UK — Joseph Kim ...
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International trends in dual antiplatelet therapy among PCI-treated STEMI and NSTEMI patients: Pendant study in the UK
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-16
Organisations:
Joseph Kim - Chief Investigator - IQVIA - UK
Mounika Parimi - Corresponding Applicant - IQVIA - UK
- Collaborator -
Bharat Thakrar - Collaborator - IQVIA
Catrina Richards - Collaborator - IQVIA Ltd
Jessica Lundbom - Collaborator - IQVIA Ltd
Mar Pujades Rodriguez - Collaborator - IQVIAOutcomes:
Primary outcomes are:
The occurrence and the time to the following switches between P2Y12 inhibitors:
? escalation to prasugrel or ticagrelor in patients treated with clopidogrel at baseline index date;
? de-escalation to clopidogrel in patients treated with prasugrel or ticagrelor at baseline index date.To account for uncertainty in the estimation of the duration of drug exposure, patients will be considered as switching between P2Y12 inhibitors if the new antiplatelet is prescribed for a period of [-7 days; +7 days] from the end date of exposure to the former antiplatelet.
Secondary outcomes are:
All-cause death; Cardiovascular death; Non-fatal myocardial infarction; Non-fatal ischemic stroke; MACE (Major Adverse Cardiac Event, i.e. first occurrence of non-fatal ischemic stroke, non-fatal myocardial infarction or all-cause death); Major bleeding (i.e. hospitalisation with a primary diagnosis of bleeding); Coronary revascularisation (i.e. PCI or coronary artery bypass graft surgery [CABG])Description: Technical Summary
This study aims to describe the switch patterns between P2Y12 inhibitors in patients treated with percutaneous catheter intervention (PCI) and dual antiplatelet therapy (DAPT: combining aspirin with a P2Y12 inhibitor) for ST-elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI). The study will also evaluate the impact that these switches have on the risk of cardiovascular events and major bleeding and describe characteristics of DAPT users. The study will use CPRD data linked to HES and ONS to create a cohort of all PCI-treated patients for STEMI or NSTEMI, aged ?18 years and initiating DAPT between 2015 and 2018. Diagnoses and procedures will be obtained from CPRD or HES data, drug information from CPRD and death data from ONS.
First switch between P2Y12 inhibitors will be described in terms of counts, percentages and incidence rates with 95% confidence intervals (CI) and median time to switch estimated using Kaplan-Meier methods. In secondary analyses, time to all-cause death and cardiovascular outcomes (myocardial infarction, ischaemic stroke, coronary revascularisation and cardiovascular death), will be assessed using Kaplan-Meier analysis amongst patients experiencing different patterns of medication switch. In patients initiated with prasugrel/ticagrelor-based DAPT, the associations between MACE and major bleeding with P2Y12 inhibitor de-escalation (i.e. switching from more to less potent P2Y12 inhibitors from prasugrel or ticagrelor to clopidogrel) will be assessed using time-dependent exposure Cox proportional hazards models; and the net clinical benefit determined by subtracting aggregate incidence rate of major bleeding from the aggregated incidence rate of MACE over one year of follow-up in de-escalating patients versus patients remaining on prasugrel or ticagrelor. Patient characteristics will also be described, overall, by switch pattern and outcome.
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Investigation into changes in Prostate Specific Antigen (PSA) testing rate over time: A join point analysis — Richard Martin ...
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Investigation into changes in Prostate Specific Antigen (PSA) testing rate over time: A join point analysis
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-17
Organisations:
Richard Martin - Chief Investigator - University of Bristol
Emma Turner - Corresponding Applicant - University of Bristol
Chris Metcalfe - Collaborator - University of BristolOutcomes:
PSA testing rates; biopsy rates; prostate cancer rates; prostate cancer metastases, all-cause mortality.
Description: Technical Summary
The controversy surrounding population based, PSA screening for prostate cancer remains, largely because of concerns about overtreatment in the face of limited benefit. CAP provided the first and only robust evidence comparing a low-intensity PSA-based screening strategy (single screen) with no screening, designed to reduce over-detection/over-treatment while seeking a mortality benefit. After median 10 years follow-up there was no evidence of differences in prostate cancer specific or all-cause mortality. These data have informed national and international guidelines for the use of PSA testing for prostate cancer, however the impact on clinical care is unknown.
Our specific aims are to:
i) investigate temporal trends in PSA testing and prostate biopsy rates
ii) determine if temporal trends vary by broad age groups and geographical area
iii) identify any changes in trends using join-point analysis and relate these to the dates of key publications and policy documents.
iv) assess changes in rates of prostate cancer metastases and all-cause mortalityWe will employ join point regression to quantify any changes in PSA testing and biopsy rates, prostate cancer metastases and mortality over time, overall and stratified by age group and geographical location.
We will conduct a join point regression analysis to:
i) pinpoint the timing (with 95% CIs) of trend quantify per annum rates of change (with 95% Cis);
ii) test the strength of statistical evidence for any observed rate changes.We will relate the timing of trend change to CAP publication with consideration of Cis.
READ codes will be used to identify PSA, prostate biopsy, prostate cancer diagnosis and metastases, and mortality. Codes for family history of prostate cancer, urinary symptoms, and other factors will be used to attempt to classify reasons for PSA testing. Results will help us understand whether the updated policy guidelines have changed clinical practice.
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Examining methodology to identify patterns of consulting in primary care for different groups of patients before a diagnosis of cancer: a matched retrospective cohort study — Sarah Price ...
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Examining methodology to identify patterns of consulting in primary care for different groups of patients before a diagnosis of cancer: a matched retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-22
Organisations:
Sarah Price - Chief Investigator - University of Exeter
Sarah Price - Corresponding Applicant - University of Exeter
Bianca Wiering - Collaborator - University of Exeter
Gary Abel - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
1. Rates of face-to-face consultations between general practitioners and cases or matched controls in the 2 years before the case is diagnosed with cancer.
2. The time at which population-level consultation rate starts to increase before a diagnosis of cancer, across patient groups with different multimorbidity burden.
3. In order to define (1) and (2) above, the date of cancer diagnosis is required.Description: Technical Summary
This matched, retrospective cohort study will be set in primary care, using observational data from the Clinical Practice Research Datalink (CPRD). We will study patients with CPRD diagnostic codes for oesophageal or stomach cancer recorded between 1 January 2010 and 31 December 2019. To quantify baseline consultation rates, we will include controls (1:1) to cases on age, sex, general practice and multimorbidity burden. Multimorbidity is defined as two or more coexisting chronic conditions, and multimorbidity burden as the overall impact of different diseases in an individual, taking their severity into account.
We will develop methodology, based on time series and negative binomial/Poisson regression, to explore how the timeliness of cancer diagnosis varies between groups of patients with different multimorbidity burden. Previous work using such techniques has concentrated on the point at which the difference between consultation rates in cases and controls becomes statistically significant. This potentially introduces a bias, whose magnitude depends on sample size. Here we will build on preliminary work being done in partnership between Gary Abel and the UCL CanTest team to estimate the most likely inflection point and the uncertainty on that. Outcomes to be measured include:
1. Rates of face-to-face consultations between general practitioners and cases or matched controls in the 2 years before the case is diagnosed with cancer.
2. The time at which population-level consultation rate starts to increase before a diagnosis of cancer, across patient groups with different multimorbidity burden.
Simulation suggests that 3,000 cases and 3,000 matched controls will give us 92% power to detect a 9% difference in monthly consultation rate between groups with differing multimorbidity burden.
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Impact of suboptimal temperature exposure on health at all stages of care — Rafael Perera ...
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Impact of suboptimal temperature exposure on health at all stages of care
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-16
Organisations:
Rafael Perera - Chief Investigator - University of Oxford
Francois Cohen - Corresponding Applicant - University of Oxford
Anant Jani - Collaborator - University of Oxford
Brian Nicholson - Collaborator - University of Oxford
Clare Heaviside - Collaborator - University of Oxford
Marshall Burke - Collaborator - Stanford University
Radhika Khosla - Collaborator - University of Oxford
Sam Bickersteth - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes:
The outcome variables will be expressed in daily rates per inhabitant and per area. We will be comprehensive of all main cost entries for the NHS and patients, even though we may expect some to be more weather sensitive (e.g. consultations for respiratory diseases) than others: consultations (e.g. with GPs, nurses, phone consultations); prescriptions (by type of drug); medical tests; referrals to specialists (or consultations of specialists); hospitalisations (including admissions, but also daily attendance); and mortality (all-cause and cause-specific). We would furthermore produce several breakdowns for these outcomes, e.g. by age, gender, deprivation index, region (e.g. North, South of England), for urban/rural areas; by pathology. We will give a monetary value to each outcome (e.g. the cost of a consultation) to provide an NHS cost estimate.
Description: Technical Summary
This study will correlate health outcomes (e.g. consultations per 100,000 inhabitants) with temperature data (e.g. daily average temperatures) and estimate dose-response functions.
The dose-response functions will be estimated with daily data. The panel variable will be the geographical areas available in CPRD (practice region). Therefore, we will use CPRD individual-level data to produce an aggregated dataset of daily rates (for consultations, prescriptions, hospitalizations, mortality, etc.) to be as comprehensive as possible. The outcome variables will include:
- A large spectrum of health outcomes recorded in CPRD (consultations, medical tests, prescriptions, hospitalisations and deaths)
- Breakdown of the outcome variables by subgroups to define vulnerable populations (according to age, preconditions, cause of morbidity) and potential mechanisms linking temperature to human health (e.g. the impact of smoking on increasing the impact of cold weather on pulmonary diseases).
- Estimate a cost for healthcare by associating each intervention to a cost estimate, and look at the dose-response function of the aggregate healthcare cost to changes in temperature.The econometric specification will control for seasonality and location-specific unobservables. It would also include temperature lags to account for short-term dynamics, and specifications may include confounders such as precipitation and pollution. We would furthermore estimate models at monthly and yearly levels to account for medium-term adaptation to cold and heat. We will provide estimates of climate change impacts with general circulation models.
Finally, the project aims to select exogenous policy changes (e.g. changes in electricity and housing prices, the introduction of Universal Credit, the Two-Child limit or the cuts introduced on disability benefits) and see if these have had an impact on the temperature-morbidity/mortality relationships.
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The prevalent new-user design for cohort studies with no active comparator: The example of statins and cancer — Samy Suissa ...
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The prevalent new-user design for cohort studies with no active comparator: The example of statins and cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-22
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Overall cancer; 7 site-specific cancers: breast, colorectal, haematological, melanoma, non-small cell lung, prostate and urothelial (as in Dickerman (1))
Description: Technical Summary
The new-user cohort design is an essential tool for the conduct of observational studies of the comparative effects of drugs, including effectiveness and safety, to capture potential early effects and to properly time the confounders. While this approach is commonplace, a certain level of complexity is introduced when the comparison is not against an active comparator but rather against non-use. In this context, immortal time and other time-related bias become important threats to the validity of results. The objective of this study is to describe how the prevalent new-user design can be used in this context and to illustrate its use with the example of assessing the effect of statin use compared to non-use on the incidence of cancer. We will form a cohort of all adults in the CPRD, 30 years of age or more between January 1998 and December 2015, having at least one year of up-to-standard data and the record of a LDL cholesterol level <5 mmol/L. For each statin user, we will use the prevalent new-user design to select a reference statin non-user at the same time point as the user, matched on sex and time conditional propensity scores. Matched subjects will be followed for up to 10 years or until the occurrence of a cancer. The Cox proportional hazard model will be used to perform an intention to treat analysis that assesses the effect of statin use versus non-use on the risk of cancer occurrence.
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Area, maternal and child determinants of MMR uptake — Claire Hastie ...
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Area, maternal and child determinants of MMR uptake
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-16
Organisations:
Claire Hastie - Chief Investigator - University of Glasgow
Claire Hastie - Corresponding Applicant - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
Janeth Doji Haruna - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Paul Welsh - Collaborator - University of Glasgow
Qianqian Jiang - Collaborator - University of GlasgowOutcomes:
MMR1 at 24 months; MMR1 at 5 years; and MMR2 at 5 years.
Description: Technical Summary
This study aims to explore potential predictors of low MMR vaccine uptake. Predictors fit broadly into three categories: area level exposures; maternal characteristics; and pregnancy history/current pregnancy factors. The CPRD Gold data will be used to establish a cohort of women in the pregnancy register whose pregnancies resulted in live births. Area-based socioeconomic status will be assessed based on the linked small-area data (English Index of Multiple Deprivation). Practice (including Up To Standard date), region, urban/rural classification, motherÂs age, ethnicity, religion, number of children attached to the mother, parity, number of miscarriages, previous infant deaths, childÂs gender, pre(eclampsia), pregnancy hypertension, gestational diabetes, preterm delivery, and maternal history of anxiety or depression will be extracted from the primary care data. The outcome variables will be MMR1 at 24 months, MMR1 at 5 years, and MMR2 at 5 years. Vaccinated and unvaccinated children will be compared on predictor variables univariately, using two sample t-tests for quantitative variables and chi-square analysis for qualitative variables. Formal analysis will comprise multiple regression. As sensitivity analyses, the primary analysis will be replicated: 1. with the outcome the 5-in-1 combined diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b vaccine (DTaP/IPV/Hib) at 12 months, 24 months and 5 years; and the outcome the combined Haemophilus influenzae type b and meningococcal group C vaccine (Hib/MenC) at 24 months and 5 years; 2. in the subset of practices that are not Up To Standard.
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Selective Serotonin Reuptake Inhibitors and the Risk of Type 2 Diabetes Mellitus in Children and Youths — Samy Suissa ...
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Selective Serotonin Reuptake Inhibitors and the Risk of Type 2 Diabetes Mellitus in Children and Youths
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-28
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Dai Cao - Collaborator - McGill University
Emma Fergusson - Collaborator - Oxford University Hospitals
Francois Montastruc - Collaborator - University Of Toulouse
Laurent Azoulay - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Soham Rej - Collaborator - McGill UniversityOutcomes:
Type 2 diabetes mellitus (T2DM)
Description: Technical Summary
SSRIs are the most commonly prescribed antidepressants in children and youths in the United Kingdom. A steady increase in the rate of SSRIs prescriptions has been observed in the last two decades in this population. However, several studies in adults and one study in children and youths suggest that SSRIs may increase the risk of type 2 diabetes mellitus (T2DM). While these studies evaluated the risk of T2DM associated with SSRIs as a class, whether differences exist between individual SSRIs is unclear. Indeed, individual SSRIs have different pharmacodynamic mechanisms, which may in turn induce different glycaemic and metabolic effects. The main mechanism of action of SSRIs involves the serotonin transporter, but affinity to other receptors with metabolic effects varies amongst SSRIs. Thus, SSRIs with higher binding affinity to these receptors may be associated with a higher risk for T2DM. We will conduct a cohort study to assess whether the use of SSRIs with strong binding affinity is associated with an increased risk for T2DM compared with use of SSRIs with weak binding affinity. The cohort will comprise all patients aged 5 to 24 years with a first prescription for an SSRI between 1990 and 2019. We will use Cox proportional hazards models to estimate the hazard ratios of T2DM associated with the use of SSRIs with strong binding affinity compared with SSRIs with weak binding affinity. Secondary analysis will explore whether the risk varies with duration of use. We will also conduct sensitivity analyses to assess the robustness of our results.
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Assessing factors associated with the COVID-19 risk in people with asthma — Chloe Bloom ...
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Assessing factors associated with the COVID-19 risk in people with asthma
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-11
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Ernie Wong - Collaborator - Imperial College Healthcare NHS Trust
Katherine Hickman - Collaborator - NHS England
Paul Cullinan - Collaborator - Imperial College London
Sarah Elkin - Collaborator - Imperial College Healthcare NHS Trust
Wisia Wedzicha - Collaborator - Imperial College LondonOutcomes:
COVID-19 diagnosis (confirmed and suspected), asthma exacerbations and ICS use
Description: Technical Summary
Three cohorts of patients with asthma, allergic rhinitis and chronic obstructive pulmonary disease will be drawn; the frequency and severity of COVID-19 will be measured in each cohort for each month in Feb-May 2020 and a matched general population cohort. Crude and standardised (age, gender) incidence will be calculated and stratified by inhaled corticosteroid (ICS) dose, eosinophil count and atopy; for each disease cohort. Poisson models will be used to compare rates between the asthma cohort and the two other patient cohorts and general population; adjusting for age, gender, BMI, socioeconomic status, smoking, inhaled medications and comorbidities. For each patient cohort, use multivariable Cox proportional hazards regression to assess the association between COVID-19 diagnosis and disease severity, ICS dose, eosinophil count and atopy. Linked data will be used for the outcome variable for hospitalised COVID-19 patients (HES) and death from COVID-19 (ONS). Compare incidence rates of asthma attacks in Feb-May2019 to Feb-Mary 2020; adjusting for confounders. Compare ICS prescriptions per patient in Feb-May2019 to Feb-Mary 2020.
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Investigating the impact of frailty on the risks and benefits of hip and knee replacement surgery — Terence O'Neill ...
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Investigating the impact of frailty on the risks and benefits of hip and knee replacement surgery
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-08
Organisations:
Terence O'Neill - Chief Investigator - University of Manchester
Michael Cook - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of Manchester
Tim Board - Collaborator - University of ManchesterOutcomes:
- All-cause and cause-specific mortality;
- Healthcare utilisation (primary care consultations, inpatient, outpatient, and A&E attendances)
- Patient reported outcome measures: EuroQol 5-dimension (EQ-5D), Oxford Hip Score/Oxford Knee Score (OHS/OKS), patient reported satisfaction (ÂHow would you describe the results of your operation?Â) and improvement (ÂOverall, how are the problems now in the hip on which you had surgery, compared to before your operation?Â)
- Frailty  measured using a frailty index (FI)Description: Technical Summary
Background:
The impact of frailty on health outcomes following hip and knee joint replacement is unknown.Objectives:
To determine whether:(i) the impact of frailty on short-term term (<1 year) and long-term (>1 year) mortality risk and also healthcare utilisation following total hip/knee replacement is different compared to the impact of frailty on mortality risk and healthcare utilisation over the same period in people who do not have a total hip/knee replacement
(ii) frailty impacts on the change in hip/knee pain and function following total hip/knee replacement surgery
(iii) the longitudinal progression of frailty is different in people with osteoarthritis (OA) compared to people without OA
(iv) having a total hip/knee replacement impacts on the longitudinal change / progression of frailty
(v) the prevalence of frailty in people who have a total hip/knee replacement has changed during the period 1998 to 2019 and whether frailty may explain the association between deprivation and the likelihood of receiving total hip/knee arthroplastyMethods:
Frailty will be determined using a frailty index. Cox and Poisson regression, respectively will be used to determine the impact of frailty on mortality and healthcare utilisation, in people who have a hip/knee replacement compared to participants who do not have a total hip/knee replacement.
Linear regression will be used to determine whether frailty impacts on the change in patient-reported outcomes 6 months after hip or knee replacement surgery. Multilevel models will be used to analyse prospective change in frailty index in people who have a hip/knee replacement compared to those who do not have surgery and also in people who have OA compared to those who do not have OA. Multivariable Poisson regression models will be used to determine whether the prevalence of frailty in people who have total hip or knee replacement surgery has changed over time.
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Reducing the burden of recurrent wheeze in preschool children in England: A birth cohort study — Sonia Saxena ...
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Reducing the burden of recurrent wheeze in preschool children in England: A birth cohort study
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-01
Organisations:
Sonia Saxena - Chief Investigator - Imperial College London
Hanna Creese - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Dougal Hargreaves - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Sejal Saglani - Collaborator - Imperial College LondonOutcomes:
Recurrent wheeze:
We will define recurrent wheeze attack as any of the following within 12 months of an initial wheeze attack:
1) GP consultations for wheeze or asthma (Appendix A)
2) ED visits either within 48 hours of a GP consultation for wheeze/asthma or which resulted in treatment with nebulised or inhaled medication.
3) Unplanned hospital admissions with a primary diagnosis of wheezing/asthma within the 12-month-period following initial wheeze attack (Appendix C).Recurrent wheeze will be categorised by the number of all attendances.
Coding of ED visits is sufficient for events but data quality are insufficient for ICD 10 codes to be relied on for the reason for the visit. Hence we will use this combined approach to identify visits to ED for wheeze. This will miss children who self-refer directly to ED for wheeze or who do not attend their GP in the 48 hours before or after a wheeze episode.Description: Technical Summary
Reducing the burden of preschool wheeze is a priority for improving child health in the United Kingdom (UK), which has the highest number of children dying from wheeze attacks in Europe. Compared with older children (?5 years), preschool children (aged 1-5 years, up to fifth birth birthday) are at greater risk of wheeze attacks.
In most cases, respiratory wheeze does not require medical treatment, but some preschool children develop recurrent wheeze leading to poor health and frequent use of health care. Recurrent wheeze is influenced by genetic predisposition and exposure to respiratory infections and air quality of their surrounding environment. While studies have reported risk factors for acute asthma attacks in school-aged children, few studies have examined the risk factors for re-admission or future attacks in the preschool population. Recurrent wheeze is potentially preventable through effective primary care following an initial wheeze attack and limiting environmental risk factors such as passive smoke exposure.
Using Poisson regression, we will examine the frequency and timing of recurrent wheeze in preschool children, defined as two or more in the last 12 months, presenting to GPs, emergency departments and resulting in unplanned hospital admission. We will examine the extent to which preventive healthcare, such as developmental reviews and vaccinations, and responsive care including asthma reviews and management plans after the first wheeze attack, impact childrenÂs rates of subsequent wheeze attacks. We will also investigate the extent to which area deprivation, maternal smoking and having a family history of asthma such as maternal asthma diagnosis predicts rates of recurrent wheeze.
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A comparison of the prevalence of electronic health record diagnoses of herpes zoster and simplex with self-reported prevalence from national population surveys and cohorts from the United Kingdom — Charlotte Warren...
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A comparison of the prevalence of electronic health record diagnoses of herpes zoster and simplex with self-reported prevalence from national population surveys and cohorts from the United Kingdom
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-07
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Judith Breuer - Collaborator - University College London ( UCL )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sharon Cadogan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
EHR-recorded prevalence of:
1. Herpes zoster
2. Cold sores
3. Genital herpesDescription: Technical Summary
The alpha herpesviruses varicella zoster virus and herpes simplex viruses types 1 and 2 are common human pathogens which are responsible for substantial morbidity. After primary infection, these viruses establish lifelong latency, mainly in dorsal root ganglia. Reactivation occurs periodically, particularly at times of immune-suppression and may lead to characteristic signs and symptoms. Varicella zoster virus reactivation, known as herpes zoster, causes a painful, blistering dermatomal rash, while for herpes simplex virus, reactivation includes mucocutaneous manifestations such as cold sores and genital ulcers. These viruses can also give rise to rare complications such as encephalitis, which necessitate medical care.
There have been many EHR-based studies of herpes zoster, with far fewer focussed on herpes simplex. While no validation studies exist, it is likely that herpes zoster is reasonably well-captured in EHRs, with high specificity (due to the characteristic clinical presentation) and relatively high sensitivity (as most people consult). Patterns of consulting may however differ by disease severity and age. It is also likely that herpes simplex reactivation is much less well-recorded in EHRs given its often mild clinical course, which would lead to a large degree of under-ascertainment and potential misclassification of herpes simplex in EHR studies.
In this cross sectional study we aim to validate prevalent diagnoses of herpes zoster, cold sores and genital ulcers due to herpes captured in both primary and secondary care EHRs using CPRD data linked to Hospital Episode Statistics by comparing against self-reported prevalence rates from cross-sectional population surveys (Health Survey for England; National Survey of Sexual Attitudes and Lifestyles) and cohorts (EPIC Norfolk) in similar populations and time periods. We will calculate age- and sex-specific rates as well as age-standardised prevalence rates for comparisons. We will further stratify results by factors such as ethnicity, socioeconomic status, region and calendar time. This will inform the design of future research studies into the risk factors and outcomes of for herpes zoster and simplex episodes as well as the effectiveness of prevention and treatment options.
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Clinical contact with health services for mental illness and self-harm before, during and after the COVID-19 pandemic — Darren Ashcroft ...
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Clinical contact with health services for mental illness and self-harm before, during and after the COVID-19 pandemic
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-06-01
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Roger Webb - Corresponding Applicant - University of Manchester
Carolyn Chew-Graham - Collaborator - Keele University
Holly Hope - Collaborator - University of Manchester
Kathryn Abel - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Matthias Pierce - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Paraskevi Taxiarchi - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Sarah Steeg - Collaborator - University of ManchesterOutcomes:
Incidence of:
- Mental illness diagnoses: anxiety disorder; depression; schizophrenia; bipolar disorder; psychoses; eating disorder; personality disorder; PTSD
- Fatigue syndromes including chronic fatigue syndrome (CFS) and post-viral fatigue syndrome (PVFS)
- Prescriptions for psychotropic medication (including benzodiazepines, antidepressants, antipsychotics and other psychotropic medicines)
- Referrals to mental health services from primary care
- Inpatient psychiatric care
- Clinically-significant alcohol use
- Non-fatal self-harm (identified from primary care records) and hospital-presenting self-harm
- Alcohol-related hospital admission
- Death by suicide
- Death from alcohol-related causes
- Death from accidental poisoningsPrevalence of:
- GP contact for mental illness and self-harm (including face-to-face, telephone and video consultations)
- Prescriptions for psychotropic medicationWe wish to examine sleep disorders/problems as an additional outcome in Phase 3 of our study.
Description: Technical Summary
We aim to:
(i) examine the incidence and prevalence of primary care contact for mental illness and self-harm, and referrals to mental health services before, during and after the acute phase of the COVID-19 pandemic (Phase 1)
(ii) examine longer term temporal trends in primary and secondary care contacts for mental illness, non-fatal self-harm and suicide rates, following the COVID-19 pandemic (Phase 2)
(iii) follow up persons diagnosed with COVID-19 to examine likelihood of specific mental illness, fatigue syndromes and episodes of self-harm identified from primary and/or secondary care, alcohol-related hospital admission, prescriptions for psychotropic medication in primary care and death by suicide, accidental poisoning or alcohol-related causes (Phase 3).
For all phases we aim to examine differences by age group, gender, ethnic group and practice-level deprivation (IMD quintiles). We will also examine trends in the modes of GP consultation over time.
For Phase 1 we will use primary care electronic health records included in CPRD GOLD and CPRD Aurum. First, we will estimate incidence rates of specific mental illness diagnoses, clinically significant alcohol use, prescriptions for psychotropic medication, GP referrals to psychiatric services (such as community mental health, outpatient mental health, e.g. ÂpsychiatristÂ, and drug and alcohol services) and episodes of self-harm. Second, we will estimate prevalence of patient contact with general practice, prescriptions for psychotropic medication and hospital-presenting self-harm among individuals with a prior diagnosis of a mental disorder and/or history of self-harm.
Primary care records will be linked to HES A&E, HES APC, HES Outpatient, patient postcode-level IMD score and ONS Death Registrations for Phase 2 and 3. Incidence rates and prevalence values will be stratified by gender, age group, ethnic group and practice-level IMD quintile. Joinpoint analysis will be used to examine significant differences in temporal trends. For Phase 3 we will use cohort study designs.
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ID 96: De-identified Data Access Request: Covid-19 vaccine uptake monitoring and targeting — Westminster and Kensington and Chelsea Local Authorities...
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ID 96: De-identified Data Access Request: Covid-19 vaccine uptake monitoring and targeting
Legal basis:Local Authority Support to NHS delivery and Population Health
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-20
Opt Outs: no information provided./p>
Organisations: Westminster and Kensington and Chelsea Local Authorities
Description: Covid-19.
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De-identified Data Access Request: NWL Health Research Register Request – RADAR — Imperial College Health Partners...
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De-identified Data Access Request: NWL Health Research Register Request – RADAR
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: missing. Commercial
Source
2020 - 05
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Identifying the links between hearing loss and dementia — unknown...
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Identifying the links between hearing loss and dementia
Where: unstated
When: 2020-5-5
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Building on previous analysis, this project has drawn on existing statistics and data on hearing loss and dementia in Wales. Preliminary research has outlined the evidence base and need for hearing loss consideration in services across Wales, and has identified possible options for further research using datasets in the SAIL databank.
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Covid-19 Testing Results (Identifiable) (Direct Care and Secondary Uses) — Public Health Wales (PHW)...
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To contact individuals to inform them whether they have Covid-19 and should be self-isolating and to provide additional information about healthcare, etc. — IG-00510
Recipient Data Controller Organisation(s) : Public Health Wales (PHW)
Approval Date: 18/05/2020
Purpose for which the data is being used: To contact individuals to inform them whether they have Covid-19 and should be self-isolating and to provide additional information about healthcare, etc.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care and Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â The national data opt out does not apply outside England.
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Covid-19 Testing Results (Pseudonymised ) (Secondary Uses) — NHS England...
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For data analysis and linking with other data for the purposes of producing COVID-19 dashboards made available to authorised users through the COVID-19 Data Store — IG-00495
Recipient Data Controller Organisation(s) : NHS England NHS Improvement
Approval Date: 01/05/2020
Purpose for which the data is being used: For data analysis and linking with other data for the purposes of producing COVID-19 dashboards made available to authorised users through the COVID-19 Data Store
Dataset: Covid-19 Testing Results
Category of Data: Pseudonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE/I COPI Notice
Common Law Duty of Confidentiality: NHSE/I COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose GDPR Article 9(2)(i) â Public health purposes DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Not Applied â Legal Obligation & in Public Interest.
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Household Setting Transmission Evaluation Dataset (HOSTED) (Pseudonymised ) (Secondary Uses) — Public Health England...
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To support analyses of the epidemiology of Covid-19 infections in households. — IG-00350_1
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 23/05/2020
Purpose for which the data is being used: To support analyses of the epidemiology of Covid-19 infections in households.
Dataset: Household Setting Transmission Evaluation Dataset (HOSTED)
Category of Data: Pseudonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(i) â Public health DPA 2018 Part 1 Schedule 1 para 3 â Public health
National Data Opt-out Applied: Not Applied â Legal obligation overrides & in Public Interest.
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Shielded Patient List (SPL) (Anonymised in accordance with ICO Code of Practice) (Secondary Uses) — University of Oxford...
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For the development and validation of a risk prediction algorithm to estimate short term adverse outcomes from COVID-19 disease which can be used as a risk stratification tool and to inform national shielding policy. — IG-00652
Recipient Data Controller Organisation(s) : University of Oxford
Approval Date: 23/05/2020
Purpose for which the data is being used: For the development and validation of a risk prediction algorithm to estimate short term adverse outcomes from COVID-19 disease which can be used as a risk stratification tool and to inform national shielding policy.
Dataset: Shielded Patient List (SPL)
Category of Data: Anonymised in accordance with ICO Code of Practice
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(1) Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymised in accordance with ICO Code of Practice and not confidential data.
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymised in accordance with ICO Code of Practice and not confidential data.
GDPR and Data Protection Act 2018: N/A - Anonymised in accordance with ICO Code of Practice. No GPDR legal basis are required.
National Data Opt-out Applied: Not Applied â Anonymised in accordance with ICO Code of Practice.
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Shielded Patient List (SPL) Hospital Data Analysis (COVID19) (Aggregate (small numbers not supressed)) (Secondary Uses) — NHS England...
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To investigate what available hospital data could show about the impact of shielding measures for people on the Shielded Patient List (SPL). — IG-00605
Recipient Data Controller Organisation(s) : NHS England Office of National Statistics (ONS) Department of Health and Social Care (DHSC)
Approval Date: 23/05/2020
Purpose for which the data is being used: To investigate what available hospital data could show about the impact of shielding measures for people on the Shielded Patient List (SPL).
Dataset: Shielded Patient List (SPL) Hospital Data Analysis (COVID19)
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(1) Health and Social Care Act 2012 section 261(2)(e)
Common Law Duty of Confidentiality: N/A - Anonymnous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: N/A
Common Law Duty of Confidentiality: N/A - Anonymnous and is therefore not confidential or personal data.
GDPR and Data Protection Act 2018: N/A - Anonymnous and is therefore not confidential or personal data.
National Data Opt-out Applied: Not Applied â Anonymous Data.
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Incidence, Prevalence and Burden of Narcolepsy in Europe: A Multi-database Study — Nawab Qizilbash ...
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Incidence, Prevalence and Burden of Narcolepsy in Europe: A Multi-database Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-10
Organisations:
Nawab Qizilbash - Chief Investigator - OXON Epidemiology - Spain
Bélène Podmore - Corresponding Applicant - OXON Epidemiology - Spain
Andrea Falco - Collaborator - OXON Epidemiology - Spain
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Kirsty Andresen - Collaborator - OXON Epidemiology - Spain
Lorena Baquero - Collaborator - OXON Epidemiology - Spain
MIGUEL DESCALZO - Collaborator - OXON Epidemiology - Spain
Raúl Sánchez - Collaborator - OXON Epidemiology - Spain
Rosie Barnett - Collaborator - OXON Epidemiology - Spain
Shreya Davé - Collaborator - Takeda Pharmaceuticals Company LtdOutcomes:
Descriptive outcomes (key variables): incidence; prevalence; patient characteristics (age, sex, region, socioeconomic status and comorbidities); treatment patterns; treatment pathways (referrals); number of sleep tests and number of sickness certificates.
Comparative outcomes: all-cause, narcolepsy-related GP visits; all-cause, psychiatric, physiotherapy and narcolepsy-related referrals; all-cause, narcolepsy-related hospitalisations; all-cause, psychiatric and narcolepsy-related emergency admissions; emergency accident and injury admissions.Description: Technical Summary
The aim of this study is to quantify the incidence and prevalence of narcolepsy in the UK as well as understand the patient characteristics, treatment pathways (before and after diagnosis), treatment patterns and associated healthcare resource use (HCRU) of individuals with narcolepsy. This study will be an observational retrospective matched cohort study. It will be primarily descriptive in nature though HCRU rates and accident and injury rates in individuals with narcolepsy will be compared to a matched cohort of individuals without narcolepsy. Individuals will be frequency matched on the basis of age and sex. HES Admitted Patient Care and A&E emergency linked datasets will be used to assess the hospitalisations and emergency admissions rates in the context of a patientÂs clinical journey and their HCRU.
Incidence and period prevalence of narcolepsy will be calculated for the years 2000-2019 and will be stratified by age, sex and year and later extrapolated to a standardised European population using the direct standardisation method. Descriptive statistics will be used to summarise the patient characteristics, treatments patterns and a patients clinical journey through the healthcare system for the years 2014-2019. Exploratory data analysis with visualisation techniques (e.g. frequent pattern analytics, flow visualisation) will be used to describe common patterns in patients sequence of treatment and clinical interventions in the years 2014-2019. Annualised HCRU and emergency accident and injury rates will be calculated and modelled by time using Poisson regression analyses for the years 2014-2019.
Source -
Antimicrobial stewardship during the COVID-19 epidemic. Cohort study — Martin Gulliford ...
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Antimicrobial stewardship during the COVID-19 epidemic. Cohort study
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-04
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Emma Rezel-Potts - Collaborator - King's College London (KCL)Outcomes:
Antibiotic prescriptions, including sub-groups of broad-spectrum antibiotic prescriptions.
Consultations for respiratory tract infections, urinary tract infections and skin infections.
Consultations for COVID-19.
Description: Technical Summary
The COVID-19 pandemic has potential to impact on many areas of medical practice. This study aims to determine how antibiotic prescribing is changing during the pandemic. We expect that antibiotic prescribing might increase because large numbers of people are having respiratory infections. Primary care consultations may not be taking place in a face-to-face format, possibly leading to greater antibiotic prescribing because clinical assessments are more limited. This study will analyse antibiotic prescribing in CPRD GOLD, later validating findings in CPRD Aurum. We will include all general practices in England that provide UTS data throughout 2017 to the present. We will take a random sample of registered patients, giving a total sample of 400,000-500,000. We will analyse antibiotic prescriptions by month, as well as broad spectrum antibiotic prescriptions, and consultations for respiratory tract, urinary tract and skin infections as the common infections in primary care. We will evaluate whether the pandemic has been associated with changes in infection consultations and antibiotic prescriptions. We will also evaluate numbers of COVID-19 consultations. We will visualise the data with a scatterplot of monthly rates, fitting smoothed curves to evaluate whether onset of the pandemic in February 2020 has been associated with any departures from trend. We will fit Poisson models to 2017 to 2019 data to predict expected antibiotic prescribing in 2020. We will also fit interrupted time series models. The results will show how antibiotic prescribing has changed during the pandemic and will inform continuing antimicrobial stewardship efforts.
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A qualitative questionnaire based study exploring attitudes, beliefs and experiences of patients and healthcare professionals, in relation to short-acting beta-2-agonist and inhaled corticosteroid prescription and adherence — Jennifer Quint ...
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A qualitative questionnaire based study exploring attitudes, beliefs and experiences of patients and healthcare professionals, in relation to short-acting beta-2-agonist and inhaled corticosteroid prescription and adherence
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Anne-Marie Russell - Collaborator - Imperial College London
Ekaterina Maslova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Erin Tomaszewski - Collaborator - Astra Zeneca Ltd - UK Headquarters
Rupa Sisodia - Collaborator - Imperial College LondonOutcomes:
Asthma reliever and maintenance medication to be stratified by BTS steps 1-5 and current asthma therapy. Outcomes include:
- Prescribing behaviours of HCP?s;
- SABA (reliever) use, frequency and triggers;
- ICS (preventer) use, frequency and triggers;
- Patient perspectives, experiences of symptoms and relationship with maintenance therapy.Description: Technical Summary
Background: Since 2006, asthma related deaths have declined, however rates in the UK are still higher than Europe, purported to be caused by the under prescribing of inhaled corticosteroids (ICS), over reliance and increased use of short-acting beta-agonists (SABA). The high use of SABA and/or ICS underuse is associated with increased healthcare resource utilization (HRU) and exacerbations resulting in increased morbidity and mortality.
This retrospective, observational and cross-sectional qualitative study, aims to understand the experiences patients diagnosed with asthma have with their disease and their relationship with treatment. Additionally, we will gain a better understanding of GPÂs and Heath Care ProfessionalÂs (HCP) prescribing behaviours.
Methods: CPRD will electronically administer a questionnaire-based survey to 130 research active GP practices who have contributed to CPRD Aurum in the last 6 months. Prior to this a process of critical appraisal will inform development of the GP and patient surveys.
A sub-set of 600 patients, aged 18 and over, with a current validated asthma code and registered with an active GP practice will be selected by CPRD. Both surveys will be electronically administered by CPRD and relayed to patients by the GP practices. The patient survey will be hosted on CPRDÂs online study platform and will be administered by CPRD. The GP survey will be hosted by [Qualtrics] and distributed to GPs by email from CPRD.
35 patients will be invited to participate in the focus group discussions and a further 4-6 patients will be selected to partake in the qualitative in-depth interviews to obtain further information on their perception, experience of asthma symptoms and relationship with SABA treatment.
Results: Descriptive statistics will characterise the participating population; proportionate responses (cox regression), trends and frequency calculations will quantify the GP and patient survey data; the audio recordings from the focus groups and in-depth interviews will be analysed using a thematic framework approach to identify common themes and patterns relating to SABA, ICS and prescribing behaviours. NVIVO software will be used to establish categories and themes. CohenÂs interrater kappa will be used to test the variability.
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Diagnosis and management of infectious disease in primary care during the COVID-19 lockdown: changes in antibacterial and antiviral use — Rachel Denholm ...
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Diagnosis and management of infectious disease in primary care during the COVID-19 lockdown: changes in antibacterial and antiviral use
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-14
Organisations:
Rachel Denholm - Chief Investigator - University of Bristol
Rachel Denholm - Corresponding Applicant - University of Bristol
Alastair Hay - Collaborator - University of Bristol
Ashley Hammond - Collaborator - University of Bristol
Christie Cabral - Collaborator - University of Bristol
Claire Woodall - Collaborator - University of Bristol
Jessie James - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Bristol
Shiyu Jin - Collaborator - University of BristolOutcomes:
Four main outcomes will be measured in this study.
 Changes in practice-level rates of specific infectious disease diagnoses, per 1,000 patients pre and during COVID-19 lockdown
 Changes in practice-level rates of antibacterial and antiviral prescribing, per 1,000 patients pre and during COVID-19 lockdown
 Change in practice-level rates of hospital attendance with specific infectious disease diagnoses, per 1,000 patients
 Antibacterial or antiviral prescription (yes/no)Description: Technical Summary
In response to the COVID-19 pandemic, the delivery of primary care has rapidly changed to meet sudden increases in demand and social distancing measures to reduce the potential spread of infection. Furthermore, patients are changing their health seeking behaviour, with reductions in health service utilisation. Infectious diseases are the most common presentations treated in primary care, with respiratory tract infections the most frequently prescribed antibiotics. Given these changes in health service use and delivery, it is unknown how the management of infectious disease in primary care will be impacted during the COVID-19 lockdown. Opportunities for early intervention may be being missed, potentially leading to serious complications and greater use of acute care services during a period when they are already overwhelmed.
The objective of this study is to investigate changes in diagnosis and treatment of infectious diseases, and associated hospital admissions, during the COVID-19 UK lockdown.
We will conduct a retrospective cohort analysis comparing practice-rates of infectious disease diagnoses and antibacterial and antiviral prescriptions pre and during the COVID-19 lockdown. We will investigate practice and patient-level factors associated with changes in the treatment of specific infectious diseases, including COVID-19. Furthermore, we will examine whether changes in practice-level hospital attendance for infectious diseases are associated with changes in diagnosis and prescribing in primary care. Mixed-effect regression models will be used to investigate associations with practice and patient-level factors.
Little attention is currently being paid to general practice, and results from this study will provide an insight into the changes in diagnosis and treatment of the most common presentations in primary care during COVID-19 lockdown, and the potential impact on hospital attendance for non-COVID-19 infections. Findings will inform the delivery of primary care for the management of infectious disease during a potential COVID-19 second wave, expected in Autumn.
Source - and 25 more projects — click to show
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The association between amoxicillin exposure in infancy and the development of asthma in later childhood in the UK: A retrospective cohort study using Clinical Practice Research Datalink — Samantha Lane ...
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The association between amoxicillin exposure in infancy and the development of asthma in later childhood in the UK: A retrospective cohort study using Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-04
Organisations:
Samantha Lane - Chief Investigator - Drug Safety Research Unit
Samantha Lane - Corresponding Applicant - Drug Safety Research Unit
Abena Amoah - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Debabrata Roy - Collaborator - Drug Safety Research Unit
Estelle McLean - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Data to be extracted from the records will include the following, for main and secondary analyses and to determine the effects of confounding and effect modification.
- Asthma diagnosis between the ages of zero and ten years (inclusive)
- Duration of initial exposure
- Indication for amoxicillin at initial exposure
- Dose of amoxicillin at initial exposure
- Frequency of exposure (if >1 amoxicillin prescription between ages 0 and 11 months, inclusive)
- Patient demographics
- Family history of asthma
- Prescription of an asthma medicationDescription: Technical Summary
This retrospective cohort study will examine the risk of asthma amongst children exposed to amoxicillin between the ages 0 and 11 months (ÂinfancyÂ), inclusive. The study will also assess changes in the risk of asthma depending on the frequency of exposure during infancy. A time-to-event analysis will be conducted amongst exposed patients who developed asthma between the ages zero to ten years (inclusive), to determine the expected time between initial exposure to amoxicillin (during infancy), and development of asthma in later childhood.
All patients who were born between 01 January 2009 and 31 December 2009 will be included in the study. Antibiotic prescribing practices change over time, so including all children born in 2009 will provide the most up-to-date information while allowing ten years of follow-up time. Including all children born in this calendar year will ensure the study is adequately powered. The cohort will be examined to determine children who were and were not exposed to amoxicillin during infancy. All children will be followed up and censored at first recorded asthma code, their 11th birthday, or loss to follow-up (whichever is earliest).
Categorical data will be presented in tables, continuous data will be described using appropriate summary statistics (mean/SD). Incidence risk of asthma amongst the exposed, the unexposed and the overall cohort will be calculated. Where possible this will be stratified by sex, age, and other relevant covariates. Logistic regression will compare risk of asthma in the exposed and the unexposed, whilst allowing for adjustment for confounding variables and/or effect modification.
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Investigating inflammatory conditions in relation to colorectal cancer incidence and mortality by subsite and clinical features at presentation — Amanda Cross ...
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Investigating inflammatory conditions in relation to colorectal cancer incidence and mortality by subsite and clinical features at presentation
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Amanda Cross - Chief Investigator - Imperial College London
Ruth Disney - Corresponding Applicant - Imperial College London
Amanda Cross - Collaborator - Imperial College London
Andrew Hart - Collaborator - University of East Anglia
David Muller - Collaborator - Imperial College London
Katherine Wooldrage - Collaborator - Imperial College London
Konstantinos Tsilidis - Collaborator - Imperial College LondonOutcomes:
Primary outcome measures:
Incidence of colorectal cancer (overall and by subsite);
Signs and symptoms associated with colorectal cancer (overall and by subsite);
Colorectal cancer diagnostic interval;
Colorectal cancer stage at diagnosis.Secondary outcome measures:
All-cause mortality;
Colorectal cancer mortality (overall and by subsite).Description: Technical Summary
Using data from Clinical Practice Research Datalink (CPRD) with linkage to Hospital Episode Statistics (HES), the cancer registry (NCRAS) and Office of National Statistics (ONS), we will investigate the risk of colorectal cancer (CRC) incidence and mortality by subsite in patients with IBD or gallstones (objective one). Additionally, we will examine the clinical features of CRC by subsite and investigate the association between diagnostic interval and stage at diagnosis (objective two).
Methods
Objective one: Population-based cohort study design. Incident cases of IBD or gallstones diagnosed within a 25-year period will form two exposure cohorts, followed-up for CRC incidence and mortality, and compared with reference cohorts matched for age, sex and GP practice. We will use Cox regression to estimate hazard ratios (HR) adjusted for confounders for CRC incidence and mortality by subsite. HRs will be calculated for each cohort (gallstones/IBD) and stratified by age, gender, IBD type and record of cholecystectomy for the gallstone cohort. We will also calculate HRs by calendar period, stratified by time since IBD/gallstone diagnosis, to examine temporal trends in CRC incidence and mortality by subsite.Objective two: Nested case-control study design. We will use conditional logistic regression to select and quantify key clinical features or combinations of features indicative of high risk of CRC overall and by subsite for three separate patient groups; patients diagnosed with IBD, patients diagnosed with gallstones and an Âaverage risk populationÂ. We will then go on to examine the relationship between diagnostic interval and stage at diagnosis (early stage versus advanced disease), controlling for important patient characteristics such as age, sex, co-morbidity and route of presentation (emergency) using logistic regression with restricted cubic splines. The initial model will assess total diagnostic interval for all CRC subsites. Subsequent models will assess primary and secondary care intervals separately and CRC by subsite.
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Glycaemic Control in Type 2 Diabetes Patients after Switching from Basal-Bolus Treatment to Biphasic Insulin Aspart 30/70: a Descriptive Study — Uffe Christian Braae ...
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Glycaemic Control in Type 2 Diabetes Patients after Switching from Basal-Bolus Treatment to Biphasic Insulin Aspart 30/70: a Descriptive Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Uffe Christian Braae - Chief Investigator - Novo Nordisk
Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Anders Boeck Jensen - Collaborator - Novo Nordisk
Melanie Davies - Collaborator - University of Leicester
Pranav Kelkar - Collaborator - Novo NordiskOutcomes:
HbA1c over time; weight over time; discontinuation of BIAsp 30; BMI at index date; diabetes duration at index date; previous basal insulin treatment; previous bolus insulin treatment; concomitant bolus insulin treatment; history of hypoglycaemia; incidence of hypoglycaemia.
Description: Technical Summary
Premixed insulins offer the convenience of fewer daily injections and better adherence in T2DM patients requiring both fast- and long-acting insulin treatment. Clinical trials have found the treatment effect to be comparable to basal-bolus treatment, however little is known about glycaemic control in patients switching from basal-bolus treatment to Biphasic Insulin Aspart 30/70 (BIAsp 30) in the real world. This study aims to investigate glycaemic control and other clinical characteristics in T2DM patients switching from basal-bolus treatment to BIAsp 30 in a population-based study in the UK. Data will be extracted from the CPRD database allowing for an analysis of the effect of switching to BIAsp 30 in a real-world setting. BIAsp 30 naiive patients will be followed after switching from basal-bolus treatment and their change in HbA1c will be analysed using a mixed model of repeated measures (MMRM). Treatment adherence will be evaluated by analysing the time until discontinuation. The study will provide knowledge of glycaemic control and clinical characteristics in T2DM patients switching from basal-bolus to BIAsp 30 in the real world.
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Consultations for non-specific symptoms commonly reported with COVID-19 and other acute respiratory infections in the Clinical Practice Research Datalink: long term trends and patient characteristics — Puja Myles ...
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Consultations for non-specific symptoms commonly reported with COVID-19 and other acute respiratory infections in the Clinical Practice Research Datalink: long term trends and patient characteristics
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-04
Organisations:
Puja Myles - Chief Investigator - CPRD
Tarita Murray-Thomas - Corresponding Applicant - CPRD
Achim Wolf - Collaborator - CPRD
Daniel Dedman - Collaborator - CPRD
Janet Valentine - Collaborator - CPRD
Tim Williams - Collaborator - CPRDOutcomes:
Primary:
- Weekly and monthly consultation rates for fever, cough, and fatigue or myalgia in CPRD GOLD and CPRD Aurum, stratified by age group, gender, level of social deprivation, practice region and rural/urban classification.Secondary:
- Demographic and clinical characteristics including comorbidities, prior prescribing and health care resource use, in patients with fever, cough, and fatigue or myalgia during the 2019/20 flu season.
- Weekly consultation rates for COVID-19, based on specific codes introduced during March 2020, or relevant existing coronavirus codes, from January 2020 onwards.
- Demographic and clinical characteristics and presenting symptoms of patients with a specific COVID-19 diagnosis, or relevant coronavirus code from January 2020 onwards.Description: Technical Summary
We will use CPRD primary care data to estimate weekly and monthly consultation rates for fever, cough, and fatigue or myalgia during 01/01/2015 Â 30/04/2020. These non-specific symptoms are reportedly common in COVID-19 and other acute respiratory infections. The rates may be useful for modelling excess recording consistent with undiagnosed mild COVID-19 cases in the early phases of the UK outbreak. Consultation rates and 95% confidence intervals for each symptom will be generated and stratified by gender, age band, level of social deprivation, region and rural/urban location.
The demographic and clinical characteristics of patients with at least one respiratory infection symptom recorded during each flu season in the study period, including the 2019/2020 flu season, will also be described. Pre-existing comorbidities including respiratory and cardiovascular conditions will be based on Read coded Quality Outcomes Framework definitions used in primary care and International Classification of Disease codes (ICD-10) for hospital data in secondary analysis. Prescribing of respiratory, cardiovascular and immunosuppressing medications as well as use of health services before and during the pandemic period will also be evaluated.
In March 2020, GP software providers introduced specific COVID-19 clinical codes, including suspected and confirmed diagnoses. Anecdotal reports suggest that prior to this time GPs may have used existing coronavirus codes to record information about COVID-19 cases. We will explore patterns of recording of COVID-19 and coronavirus codes, and if numbers permit, we will describe demographic, clinical characteristics, and presenting symptoms of patients with one of these codes recorded from January 2020.
Findings from this study will illustrate the potential for primary care data for research to inform health care planning and monitoring, as well as disease modelling.
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Surgical interventions to treat severe pressure sores  The SIPS study — Barnaby Reeves ...
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Surgical interventions to treat severe pressure sores  The SIPS study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Barnaby Reeves - Chief Investigator - University of Bristol
Jessica Harris - Corresponding Applicant - University of Bristol
Jason Kin Fai Wong - Collaborator - University of Manchester
Jeremy Rodrigues - Collaborator - Nuffield Dept of Orthopaedics
Jessica Harris - Collaborator - University of Bristol
Jo Dumville - Collaborator - University of Manchester
Louise O'Connor - Collaborator - University of Manchester
Maria Pufulete - Collaborator - University of Bristol
Matthew Ridd - Collaborator - University of Bristol
Nicky Cullum - Collaborator - University of Manchester
Rosie Harris - Collaborator - University of Bristol
Ross Atkinson - Collaborator - University of Manchester
Una Adderley - Collaborator - University of LeedsOutcomes:
1. Frequencies of activities (indicated by Read or SNOMED codes) reflecting management of pressure ulcers;
2. Referral to and discharge from community/district nursing team, generating periods of community nursing care and durations;
3. Referral to tissue viability services;
4. Admission to hospital with a pressure ulcer diagnosis, and duration of admissions related to a pressure ulcer;
5. Admission to hospital for surgical reconstruction of a pressure ulcer;
6. Mortality.Description: Technical Summary
There is little evidence about the effectiveness of surgical interventions for stage III and IV pressure ulcers. This retrospective cohort study is part of the SIPS study, which aims to define the parameters required for a randomised controlled trial of surgery for this indication.
The study will request data for patients with an index record indicating a pressure ulcer during a period of 11 years, linked to Hospital Episode Statistics (HES) records and mortality records. We expect the cohort to comprise over 75,000 pressure ulcers, using Read and SNOMED codes to ascertain eligible patients with incident ulcers.
This cohort will be used to assess usual care provided to patients, including but not limited to referrals within primary care, dressings, provision of pressure relief equipment and negative wound pressure therapy.
The objective is to describe the patients with incident severe pressure ulcers and their care pathways across primary and secondary care, e.g. management in the community, management by tissue viability nurses, admission to hospital and subsequent care.
The outcomes described will be:
1. frequencies of specific Read and SNOMED codes;
2. referral to and discharge from community/district nursing team;
3. referral to tissue viability services;
4. admission to hospital with a pressure ulcer diagnosis, and duration of admissions;
5. admission to hospital for surgical reconstruction of a pressure ulcer;
6. mortality.Mortality is an important outcome as pressure ulcers increase the risk of dying in older people. Outcome frequencies will be estimated precisely, given the large sample size. A small number of patients who have hospital admissions will be tracked through linkage with HES data.
These findings will contribute to a formal consensus process to define the populations that may benefit from reconstructive surgery, the operations that should be considered and what should constitute usual care.
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Risk of cardiovascular and related diseases in asthma patients and bronchodilator users in the UK — Chloe Bloom ...
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Risk of cardiovascular and related diseases in asthma patients and bronchodilator users in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-10
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Carlos Andres Valencia Hernandez - Collaborator - Imperial College London
Rosita Zakeri - Collaborator - King's College London (KCL)Outcomes:
Incidence and mortality rates of ischaemic heart disease (IHD), hypertension, heart failure (HF), ischaemic stroke, arrhythmia, thromboembolic disease, obstructive sleep apnoea and diabetes in asthma patients; incident ratios comparing to general population. Cardiovascular disease (IHD, HF, stroke, arrhythmia) risk from long-acting bronchodilators.
Description: Technical Summary
The annual incidence and mortality rates of cardiovascular disease and related diseases (ischaemic heart disease, hypertension, heart failure, ischaemic stroke, arrhythmias, thromboembolic disease, obstructive sleep apnoea and diabetes) will be calculated for people with asthma. Outcomes will be determined using primary care (CPRD), hospital diagnoses (HES) and death certificate diagnoses (ONS). Incidence and mortality will be compared to a randomly selected cohort of CPRD patients, that do not have asthma. A multivariable Poisson model, adjusted for risk factors (gender, age, smoking history, body mass index, eosinophil count, asthma medications, chronic obstructive pulmonary disease and socioeconomic status  using linkage with Index of Multiple Deprivation), will be used to obtain rate ratios. To determine cardiovascular risk from long-acting bronchodilators, a nested case-control will be used from a cohort of incident long-acting bronchodilator users. Exposure (long acting bronchodilator) will be categorised by type of inhaler and duration of use. The cases will matched 1:4 and conditional logistic regression will be used to estimate the association. The same analysis will also be carried out in a COPD population.
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Trend and mechanism of socioeconomic disparity in infant mortality — Frederick Ho ...
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Trend and mechanism of socioeconomic disparity in infant mortality
Datasets:GP data, CPRD Mother-Baby Link; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Frederick Ho - Chief Investigator - University of Glasgow
Frederick Ho - Corresponding Applicant - University of Glasgow
Bhautesh Jani - Collaborator - University of Glasgow
Daniel Mackay - Collaborator - University of Glasgow
Jill Pell - Collaborator - University of Glasgow
Kenneth Man - Collaborator - University College London ( UCL )
Max Allan - Collaborator - University of Glasgow
Paul Welsh - Collaborator - University of GlasgowOutcomes:
All-cause infant (<1 year old) mortality will be primary outcome; neonatal (0-27 days), and post-neonatal (28-365 days) will be secondary outcomes used in sensitivity analyses.
Description: Technical Summary
This study aims to study whether the socioeconomic disparity in infant mortality (under 1 year) has widened, narrowed, or remained stable and whether this can be explained by potential mediators: maternal age and ethnicity, smoking and drinking during pregnancy, maternal illnesses, and pregnancy complications using the CPRD Gold data. A cohort of pregnant women in the CPRD pregnancy register will be established. Stillbirths will be excluded. Deaths of their children will be ascertained through the linkage to the ONS death registration. Area-based socioeconomic status (relative deprivation) will be assessed based on the linked small-area data (twentiles of English Index of Multiple Deprivation). Child sex, year of birth, maternal age at delivery, any pregnancy complications and birth characteristics (gestational diabetes, pregnancy hypertension, (pre-)eclampsia, preterm labour, mode of delivery, and maternal prior history of mental disorders (depression and anxiety), disability, and cancer will be extracted from the primary care data. Poisson regression with robust standard errors will be used to study the trend of socioeconomic disparity. Infant all-cause death will be the outcome variable. Child sex, year of delivery, area-based deprivation, and the interaction between year of delivery and deprivation will be the predictors. Interaction tests will be used to indicate any changes in disparity. The same model will be replicated with potential mediators as additional covariates. The percentage decrease in the effect size of the interaction terms indicates the role of the mediators. As sensitivity analysis, the above primary analysis will be replicated with: 1. Generalised additive model for potential nonlinear trend; 3. Neonatal (0-27 days) and post-neonatal (28-365 days) death as outcomes; and 4. Mothers with mental health disorders, disabilities, and cancers prior to delivery excluded.
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Using the Clinical Practice Research Datalink to test medications associated with increased risk of upper gastrointestinal cancer identified from a Scottish screening study — Chris Cardwell ...
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Using the Clinical Practice Research Datalink to test medications associated with increased risk of upper gastrointestinal cancer identified from a Scottish screening study
Datasets:GP data, NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Chris Cardwell - Chief Investigator - Queen's University Belfast
Chris Cardwell - Corresponding Applicant - Queen's University Belfast
Carmel Hughes - Collaborator - Queen's University Belfast
Peter Murchie - Collaborator - University of Aberdeen
Ronald McDowell - Collaborator - Queen's University BelfastOutcomes:
Diagnosis for upper gastrointestinal cancer (oesophagus, stomach, liver, pancreas) will be determined using NCRAS cancer registration data.
Description: Technical Summary
Background: The poor survival of upper gastrointestinal cancers (including cancers of the oesophagus, stomach, pancreas and liver) highlight the need for their prevention. In a screening study we systematically examined the association between 250 prescription medications and upper gastrointestinal cancer risk in the Scottish Primary Care Clinical Informatics Unit Research (PCCIUR) database. We identified four medications which were associated with increased upper gastrointestinal cancer risk and for which there were plausible clinical mechanisms.
Aim: To determine whether associations identified between four medications and upper gastrointestinal cancer in a screening study are apparent in the Clinical Practice Research Datalink (CPRD).
Methods: A nested case-control study will be conducted, estimating the association between each medication and upper gastrointestinal cancer. In the primary analysis cases with cancer will be determined from National Cancer Registration and Analysis Service [NCRAS] data on cancer registrations. Controls will be matched to cases using age, gender, year of registration and GP practice. The index date within each matched set will be the date of the first diagnosis of a primary cancer in the case. Prescription usage will be determined prior to the index date for both cases and controls. Conditional logistic regression will be used to calculate odds ratios (ORs) and 95% confidence intervals (95%CIs) comparing the risk of cancer among users with non-users adjusting for comorbidity and lifestyle confounders.
Potential: The study could determine whether associations between medications and upper gastrointestinal cancer identified in PCCIUR are also found in CPRD. If so, these medications may require more detailed study in relation to any potential causal relationship. Medications which increase cancer risk may require revision of licensing and usage.
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Early Life Antibiotic Exposure and Incident Chronic Diseases in Childhood — Daniel B. Horton ...
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Early Life Antibiotic Exposure and Incident Chronic Diseases in Childhood
Datasets:GP data, CPRD Mother-Baby Link; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-18
Organisations:
Daniel B. Horton - Chief Investigator - Rutgers Robert Wood Johnson Medical School
Edward Nonnenmacher - Corresponding Applicant - Rutgers, The State University of New Jersey
Abner Nyandege - Collaborator - Rutgers, The State University of New Jersey
Avinash Gabbeta - Collaborator - Rutgers, The State University of New Jersey
Brian Strom - Collaborator - Rutgers, The State University of New Jersey
Cecilia Huang - Collaborator - Rutgers, The State University of New Jersey
Jason Roy - Collaborator - Rutgers, The State University of New Jersey
Martin Blaser - Collaborator - Rutgers, The State University of New Jersey
Matthew Beier - Collaborator - Rutgers Robert Wood Johnson Medical School
Soko Setoguchi - Collaborator - Rutgers, The State University of New Jersey
Tobias Gerhard - Collaborator - Rutgers, The State University of New JerseyOutcomes:
Allergic or atopic diseases: asthma, allergic rhinitis, atopic dermatitis, food allergy
Autoimmune diseases: type 1 diabetes, thyroid disease (excluding congenital), juvenile idiopathic arthritis, inflammatory bowel disease, psoriasis, celiac disease
Metabolic diseases: type 2 diabetes, obesity
Neuropsychiatric diseases: ADHD, depression, anxiety, autism spectrum disorder, and learning disabilityDescription: Technical Summary
We will investigate the relationship between exposure to antibiotics before age 2 and incident chronic diseases linked to disruption of human microbiota, including conditions affecting the immune system, central nervous system (CNS), and metabolism. Antibiotic-exposed and -unexposed cohorts of children will be generated from CPRD data. Children under age 12 will be considered in primary analysis, but additional groups under age 18 will be included in secondary analysis. The study population will include children in the linked mother-child CPRD dataset born after the up-to-standard date. Linkage of children to their mothers will allow us to adjust for prenatal antibiotic exposures, maternal medical conditions, and other confounding variables (e.g., mode of birth delivery). We will define antibiotic exposure as a prescription for antibiotics within the first 2 years of life, with further categorization by type, spectrum of activity, and number of courses prescribed. Outcomes of interest include allergic or atopic diseases (asthma, allergic rhinitis, atopic dermatitis, food allergy), autoimmune diseases (type 1 diabetes, thyroid disease, juvenile idiopathic arthritis, inflammatory bowel disease, psoriasis, celiac disease), metabolic diseases (type 2 diabetes, obesity), and neuropsychiatric diseases (attention deficit hyperactivity disorder (ADHD), depression, anxiety, autism spectrum disorder, and learning disability). With the exception of obesity, we will define outcomes primarily by Read Codes and secondarily by Read Codes combined with disease-specific treatments. Obesity will be defined by a body mass index (BMI) Z-score >2 and secondarily by a BMI Z-score >3, based on UK growth standards. Wherever possible, we will use validated outcome definitions. Subjects with a diagnosis of interest prior to age 2 will be excluded from the study of that respective outcome. We will use multivariable Cox regression to study the association between antibiotic exposure and outcomes of interest, adjusting for maternal, child, and environmental confounders, including indication for antibiotic exposure. In addition to conducting a traditional cohort study, we will also use a sibling-comparison design to compare disease incidence among siblings with discordant antibiotic exposures before age 2 using stratified Cox regression.
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Effect of metformin on incident dementia risk among adults with type 2 diabetes — Charlotte Warren...
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Effect of metformin on incident dementia risk among adults with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-28
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Carol Brayne - Collaborator - University of Cambridge
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dylan Williams - Collaborator - University College London ( UCL )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nishi Chaturvedi - Collaborator - University College London ( UCL )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rutendo Muzambi - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sophie Eastwood - Collaborator - University College London ( UCL )
Susanna Dunachie - Collaborator - University of Oxford
Outcomes: Primary outcome
1. Incident all-cause dementia
Secondary outcomes
2. Incident mild cognitive impairment
3. Incident dementia by subtype (vascular dementia, Alzheimer?s disease, other specified cause of dementia, mixed/ unspecified dementia)Description: Lay Summary
Diabetes is a major, growing health problem worldwide: in 2015, 415 million adults worldwide were estimated to have diabetes, with the figure projected to reach 642 million by 2040. As people live longer with diabetes, their risk of developing dementia increases compared to the general population. It is not clear exactly why this is, although problems with control of blood sugar, and other co-existing health conditions may play a role. Some research suggests that being on metformin  a medication to lower blood sugar  seems to protect against the risk of developing dementia. However, not all studies fully account for differences between people prescribed different antidiabetic medications, which may explain peoples different risks of developing dementia. In this study, we will use UK healthcare data to follow older individuals with newly diagnosed diabetes to investigate whether being on metformin compared to other oral antidiabetic medications is associated with lower risks of dementia and mild cognitive impairment, while controlling for other factors linked to dementia. If we see a reduction in dementia risk with metformin, we will investigate whether this is due to effects on lowering blood sugar or to other effects such as reducing infections. Our study will provide evidence for any relative benefits of metformin compared to other antidiabetic medications among people who are at higher risk of dementia. It will also help to inform the design of future studies into dementia prevention.
Technical SummaryGlobally, diabetes prevalence is expected to rise from 415 million in 2015 to 642 million by 2040. Gains in life expectancy have contributed to a diversification of diabetes-related morbidity, including effects on cognition and dementia. A systematic review and meta-analysis of 14 cohort studies showed that people with type 2 diabetes had a 60% greater risk of developing dementia those without diabetes. Dementia risk in people with diabetes is likely to be mediated through multiple mechanisms including hyperinsulinaemia, chronic hyperglycaemia and systemic inflammation. This can lead to pro-inflammatory microglial activation and accumulation of the beta amyloid and tau pathologies characteristic of AlzheimerÂs disease and other dementias. While some evidence suggests a potential protective effect of the oral hypoglycaemic agent metformin on dementia risk, existing studies show varying results and may be limited by inadequate control for confounding.
In this cohort study, we will use routinely collected primary and secondary care data to investigate the effect of metformin versus other oral antidiabetic agents newly prescribed to older individuals with incident type 2 diabetes on rates of incident dementia and mild cognitive impairment in a Ânew user active comparator design. We will use multivariable Cox proportional hazards regression to adjust for potential confounding factors and will undertake a range of sensitivity analyses to test the validity of our assumptions. We will also explore whether any effect of metformin is mediated through its glucose-lowering actions or through effects on immunomodulation.
While NICE recommends metformin use as the initial treatment for adults with type 2 diabetes, it may be less frequently used among older people or in particular ethnic groups or settings. This study will provide evidence to guide prescribing of antidiabetic medications among individuals at higher risk of dementia, and will inform further research into dementia prevention strategies.
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Prevalence, patient characteristics and treatment patterns of adult Atopic Dermatitis in UK primary care — Lill...
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Prevalence, patient characteristics and treatment patterns of adult Atopic Dermatitis in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-18
Organisations:
Lill-Brith von Arx - Chief Investigator - Eli Lilly & Co - UK
Lill-Brith von Arx - Corresponding Applicant - Eli Lilly & Co - UK
Alexandra Celia Meeks - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Beatrice Gittens - Collaborator - Eli Lilly & Co Ltd - US HeadquartersOutcomes:
- Point prevalence of AD in the adult population as per Jan 1, 2020 by 1) total prevalence 2) by age group and 3) by disease severity (moderate to severe)
- 5-year prevalence of AD in the adult population during the Jan 1, 2015-Jan 1, 2020
- Age
- GenderDescription: Technical Summary
The intention of this study is to provide reliable, current data on the prevalence and treatment patterns (topical and systemic treatment) of AD in the adult UK population. The study is cross-sectional, determining adult patients with AD in the CPRD by a validated algorithm combining diagnostic and treatment codes indicative for AD (index event) including historic data 2 years preceding the index event. The main outcome variables are counts and proportion of adult patients with AD including demographic data, comorbidities and treatment characteristics. The statistical analysis in the study is descriptive, using count and proportion of adult AD patients. The results are summarised as number (%) for categorical variables and mean (standard deviation) for continuous variables. No comparative analyses are performed. This study will generate evidence about the prevalence of adult AD in the UK based on recent data, representative for the UK population.
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Understanding the diagnosis and prognosis of the presentation of breathlessness in adults from primary care — Rachael Evans ...
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Understanding the diagnosis and prognosis of the presentation of breathlessness in adults from primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-18
Organisations:
Rachael Evans - Chief Investigator - University of Leicester
Urvee Karsanji - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Emily Petherick - Collaborator - Loughborough University
Jennifer Quint - Collaborator - Imperial College London
Kamlesh Khunti - Collaborator - University of Leicester
Matt Richardson - Collaborator - NIHR Leicester Biomedical Research Centre
Michael Steiner - Collaborator - Glenfield HospitalOutcomes:
Descriptive study
- Assess how many adults present with unexplained breathlessness and describe their co-morbidities at baseline
- Describe the number of tests and pattern of tests performed within 6 months and 2 years from presentation with breathlessness
- Describe the time to diagnosis from presentation with breathlessness
- Describe accrued diagnoses from presentation with breathlessness using the Adjusted Clinical Groups (ACG) grouper outputsPrognosis study
- Hospitalisation (indicated by hospitalisation date from Hospital Episode Statistics (HES) hospital data)
- Mortality (indicated by a death date from Office for National Statistics (ONS) mortality data)Description: Technical Summary
Breathlessness is a common presenting symptom for serious long-term conditions such as chronic heart and lung diseases; however, there are no clear guidelines how to investigate breathlessness in primary care and understand whether delays in diagnosis result in worse future outcomes. We propose to investigate adults over the age of 18 years presenting with breathlessness for the first time during 2007 Â 2017 using patient data from the Clinical Practice Research Datalink (CPRD) with data linkage to Hospital Episode Statistics (HES), Office for National Statistics (ONS) mortality data and Index of Multiple Deprivation (IMD2010) neighbourhood deprivation data. We aim to 1) describe demographics of the population at baseline for adults presenting with a first-recorded symptom of breathlessness, and gain insight into diagnostic pathways by describing investigations (from those specified in the NICE guidelines) performed and whether this contributes to the number of diagnoses made, or comorbidities and multi-morbidities accrued two years after initial presentation, 2) understand whether time to diagnosis affects the long-term outcomes of all-cause mortality and hospitalisation by performing an open cohort study and 3) predict the risk of the same long-term outcomes of all-cause mortality and hospitalisation for adults presenting with breathlessness compared to adults not presenting with breathlessness by conducting a matched cohort study after 1:1 matching on common demographic covariates. The Adjusted Clinical Groups (ACG) system is a well-established and documented patient population case-mix adjustment software which produces a range of risks relative to patient output. Using the ACG algorithm and the Charlson Comorbidity Index, we will interrogate adults at baseline to determine whether they have an incident (unexplained) or prevalent (explained) presentation with breathlessness and can categorise patients according to morbidity burden, and then again at two years to investigate accrued diagnoses following an incident presentation.
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Evaluating the clinical outcomes of antithrombotic therapy in patients with cirrhosis and atrial fibrillation or ischaemic heart disease — Harry Hemingway ...
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Evaluating the clinical outcomes of antithrombotic therapy in patients with cirrhosis and atrial fibrillation or ischaemic heart disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-12
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Alvina Lai - Corresponding Applicant - University College London ( UCL )
Aasiyah Rashan - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Christopher Tomlinson - Collaborator - University College London ( UCL )
Constantinos Parisinos - Collaborator - University College London ( UCL )
Eloise Withnell - Collaborator - University College London ( UCL )
Jurgita Kaubryte - Collaborator - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Stefanie Mueller - Collaborator - University College London ( UCL )
Wai Chang - Collaborator - University College London ( UCL )
Yen Yi Tan - Collaborator - University College London ( UCL )Outcomes:
All-cause mortality, cause-specific mortality (such as cardiovascular mortality, cancer related mortality, liver related mortality), cardiovascular (stroke, acute coronary syndrome, cardiac arrest, heart failure and transient ischaemic attack) and liver disease progression (hepatic encephalopathy, ascites and varices).
Description: Technical Summary
Patients with cirrhosis were thought to be auto anti-coagulated causing increased bleeding risks. However, this view has been challenged as studies demonstrate that patients with compensated cirrhosis have a fairly normal coagulative function, which may become altered upon the worsening of liver disease. It is now recognised that patients with cirrhosis have higher risk of thrombotic rather than bleeding complications, and anticoagulation is used to reduce the rate of decompensation and improve survival outcomes. Patients with cirrhosis, particularly those with non-alcoholic fatty liver (NAFLD) cirrhosis, share common risk factors with cardiovascular diseases. Focusing on atrial fibrillation and ischaemic heart disease, we will employ linked primary care, secondary care and mortality data in England to investigate the health outcomes of cirrhotic patients undergoing antithrombotic (antiplatelet and anticoagulant) therapy. We will perform a large-scale propensity score analysis to match cases (patients undergoing antithrombotic therapy) to controls followed by time-dependent Cox modelling on a mortality (all-cause, cardiovascular, cancer and liver), liver disease and cardiovascular disease (e.g. ischaemic and haemorrhagic stroke) progression. Our research may inform decisions on whether thromboprophylaxis should be considered for patients with cirrhosis.
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Intra-articular Corticosteroid injections in Osteoarthritis; the RUbICOn study — Daniel Prieto...
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Intra-articular Corticosteroid injections in Osteoarthritis; the RUbICOn study
Datasets:GP data, HES Admitted Patient Care; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Andrew Judge - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Amanda Burston - Collaborator - University of Bristol
Andrew Moore - Collaborator - University of Bristol
Antonella Delmestri - Collaborator - University of Oxford
Ashley Blom - Collaborator - University of Bristol
Michael Whitehouse - Collaborator - University of Bristol
Nick Snelling - Collaborator - NHS England
Rachael Gooberman-Hill - Collaborator - University of Bristol
Samuel Hawley - Collaborator - University of Bristol
Vikki Wylde - Collaborator - University of BristolOutcomes:
Current practice study:
 joint site injected (knee, hip, hand, shoulder, ankle/foot, wrist and elbow) (CPRD)Utilisation study:
Population-level use:
 incidence and prevalence of use of injections (CPRD)
 secular trends of use of injections over the GOLD overall population (CPRD)Patient-level utilisation:
 number of repeat injections over time (CPRD)
 cumulative use (number of daily defined doses of steroid/s injected in total), and medication possession ratio (number of daily defined doses of steroid injected over number of days from first to last injection) (CPRD)Safety:
 use of analgesia post-intra-articular injection (up to 1-year): paracetamol (acetaminophen), topical & parenteral NSAIDs, opioids and/or use of gabapentinoids. Number of medication prescriptions. Daily defined doses (DDD) of different types of analgesia (NSAID, opioids) received following the Index Prescription. (CPRD)
 Bleeding post-intra-articular injection and post-operative (joint replacement surgery) (up to 6-months). (CPRD)
 Infection post-intra-articular injection and post-operative (joint replacement surgery) (up to 6-months). (CPRD)
 Diabetes decompensation post-intra-articular injection and post-operative (joint replacement surgery) (up to 6-months). (CPRD and HES)
 Cardiovascular events post-intra-articular injection and post-operative (joint replacement surgery) (up to 6-months). (CPRD and HES)
 Mortality (up to 6-months). (CPRD and ONS)Association with outcomes:
 use of analgesia post-operative (joint replacement surgery) (up to 1-year): paracetamol (acetaminophen), topical & parenteral NSAIDs, opioid analgesia and/or use of gabapentinoids and anti-epileptic drugs. Number of medication prescriptions. Daily defined doses (DDD) of different types of analgesia (NSAID, opioids) received following the Index Prescription. (CPRD)
 use of steroid injections post-intra-articular injection and post-operative (joint replacement surgery) (up to 1-year). (CPRD)
 use of oral corticosteroids post-intra-articular injection and post-operative (joint replacement surgery) (up to 1-year). (CPRD)
 time to intermediate surgical interventions post-intra-articular injection including: joint injections (up to 10-years), joint arthroscopy (up to 10-years), joint debridement (meniscal and labral) (up to 10-years), subacromial decompression, rotator cuff repair acromioclavicular joint or distal clavicle resection/excision in the shoulder (up to 10-years), joint washout (lavage) (up to 10-years), ACL reconstruction (up to 10-years), joint arthroplasty (up to 10-years). (CPRD and HES)For those that receive hip and knee arthroplasty outcomes will include:
 joint infection (Wound infection, Wound dehiscence) (up to 6-months) (CPRD and HES)
 Pneumonia, Urinary tract infection (up to 6-months) (CPRD and HES)
 further surgery to the same joint (e.g. debridement, manipulation under anaesthetic, revision, reduction of hip dislocation) (up to 10-years) (CPRD and HES)
 readmission due to thrombosis, myocardial infarction and stroke (up to 6-months) (HES)
 patient reported outcomes (PROMs) including Oxford Hip Score, Oxford Knee Score and EQ5D (up to 6-months) (HES-PROMS).Feasibility study:
 Measures of effect sizes for association with outcomes between patients that did, compared to those that did not, receive intra-articular injection of corticosteroid
 proportion of primary care practitioners performing intra-articular injection of corticosteroid and practices in which intra-articular injection of corticosteroid are performed.Description: Technical Summary
Objective
To establish current practice of the use of intra-articular corticosteroid injection (IACI) for the treatment of joint pain due to osteoarthritis (OA). Then to establish the long-term safety and outcomes of the use of IACI.Method
We will use data from three large prospective routinely collected datasets: Clinical Practice Research Datalink
(CPRD) GOLD with linkage to Hospital Episode Statistics (HES) and National Patient Reported Outcomes
Measures (PROMs) data. Feasibility estimates from CPRD indicate approximately 25000 patients with knee, 9000 with hip, 5000 with hand, 3000 with shoulder, 2000 with ankle/foot and 1000 with wrist/elbow OA have received IACI with >100000 control cases available.Data analysis
Current practice will be described by analysis of population (incidence, prevalence) and patient level utilisation (number of injections, persistence/adherence) including secular trends. Safety (pain, bleeding, infection, diabetes, cardiovascular) and association of IACI with outcomes (drug utilisation, timing to surgical intervention, subsequent outcome of arthroplasty, PROMs).As intra-articular injections of corticosteroids (IACI) have not been randomly allocated due to the observational study design, we will use instrumental variables (IV), if fulfilling certain key assumptions, to address the issue of
unmeasured confounding. The instrument will be based upon clinician preference for IACI. We will perform further secondary analyses using alternative statistical methodological approaches, in order to assess the robustness of our findings. These will include: a) Propensity score (PS) matching, where this matches each patient not receiving IACI to a comparable IACI user in an attempt to minimise confounding by indication; b) Inverse probability weights (IPW), where the analysis is weighted according to the inverse of a patientÂs probability of receiving IACI. PS matching focuses on the treated population, whereas IPW estimates the average effect of treatment in the entire study population (e.g. the outcome if everyone got the intervention, compared to the outcome if no one got the intervention).
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Investigating population-wide differences in cancer disease trajectories: Identification of pre-cancer diagnostic routes and post-cancer disease trajectories in patients with multimorbidity using statistical and machine learning approaches — Harry Hemingway ...
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Investigating population-wide differences in cancer disease trajectories: Identification of pre-cancer diagnostic routes and post-cancer disease trajectories in patients with multimorbidity using statistical and machine learning approaches
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-14
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Alvina Lai - Corresponding Applicant - University College London ( UCL )
Aasiyah Rashan - Collaborator - University College London ( UCL )
Alex Ho - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Christopher Tomlinson - Collaborator - University College London ( UCL )
Constantinos Parisinos - Collaborator - University College London ( UCL )
Eloise Withnell - Collaborator - University College London ( UCL )
Jurgita Kaubryte - Collaborator - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Stefanie Mueller - Collaborator - University College London ( UCL )
Vaclav Papez - Collaborator - University College London ( UCL )
Wai Chang - Collaborator - University College London ( UCL )
Yen Yi Tan - Collaborator - University College London ( UCL )
Zareen Thorlu-Bangura - Collaborator - University College London ( UCL )Outcomes:
We will measure first occurrences of phenotypes for cancers recorded in primary care, secondary care and the cancer
registry; comorbidities in patients with cancer; all-cause mortality; all-cause hospitalisation; cancer-related mortality; healthcare utilisation; accident and emergency admissions. Phenotype definitions are available on the CALIBER data portal (https://www.caliberresearch.org/portal/phenotypes/chronological-map).Description: Technical Summary
Modelling cancer trajectories using large-scale electronic health records would help bring us a step closer to achieving personalised care and to improving resource allocation in healthcare systems. Using linked data from primary care, secondary care and the cancer registry, we will systematically analyse longitudinal differences in patients with cancer by deciphering pre- and post-cancer diagnostic routes in patients with multimorbidity. Cancer patients are routinely staged by their tumour burden/spread with limited consideration on other essential patient-centric risk factors such as the pathophysiology of comorbid illnesses. For instance, bacterial and viral infections are common risk factors for some cancers, in part due to chronic inflammatory processes that may initiate carcinogenesis. Since comorbidities in cancer patients may influence diagnosis, prognosis and treatment decision, we will investigate multimorbidity disease clusters to determine the associations between non-malignant comorbidities and cancer. We will analyse disease co-occurrences for diagnostic pairs. We will measure the period prevalence, the cumulative incidence and the median age at diagnosis for all cancer types stratified by sex, ethnicity and deprivation. Disease associations that are identified will fuel hypothesis-driven research for future studies. We will compare conventional statistical methods (Cox regression) and machine learning methods (Random Forest and Gradient Boosting Machine) for disease classification based on disease-specific risk factors. We will evaluate healthcare utilisation in primary and secondary care to ascertain the distribution of healthcare costs across different patient groups. This is particularly important as patients with multimorbidity have frequent encounters with the healthcare system and the analyses can inform solutions on improving the management of high-need patients. Details on how cancer phenotypes are choreographed throughout an individualÂs lifespan will have immense translational implications as this information can improve cancer diagnoses, prognosis stratification, treatment recommendation/efficacy and resource utilisation.
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Antithrombotic treatment and outcome of patients with acute ischemic stroke and no atrial fibrillation: A real-world study in Clinical Practice Research Datalink — Lu Wang ...
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Antithrombotic treatment and outcome of patients with acute ischemic stroke and no atrial fibrillation: A real-world study in Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-27
Organisations:
Lu Wang - Chief Investigator - Janssen US
Lu Wang - Corresponding Applicant - Janssen US
Elliot Barnathan - Collaborator - Janssen US
Gary Peters - Collaborator - Janssen US
James Weaver - Collaborator - Janssen Research & Development LLC
Jill Hardin - Collaborator - Janssen Research & Development LLC
JoAnne Foody - Collaborator - Janssen US
Patrick Ryan - Collaborator - Janssen Research & Development LLC
Zhong Yuan - Collaborator - Janssen USOutcomes:
For the incidence rate analysis, the outcome of interest is recurrent event of ischemic stroke.
Description: Technical Summary
Stroke, with majority presented as ischemic strokes, is one of the leading causes of death and long-term disability worldwide. Anticoagulants are indicated for the prevention of acute ischemic stroke (AIS) in patients with atrial fibrillation (AF). For AIS patients without AF, antiplatelets, but not anticoagulants, are recommended for the treatment and prevention of recurrent events. However, the actual use of these antithrombotic treatment for AIS patients without AF in clinical practice has not been well-characterized. The proposed study is a real-world study to examine the pattern of antiplatelet and anticoagulation treatment and outcome of recurrent stroke in patients with AIS and no prior history of AF using the Clinical Practice Research Datalink in the UK. The proposed study will include population characterization, treatment pathway analysis, and incidence rate calculation using a retrospective cohort study design. The study population are adult patients aged ?18 years who were diagnosed with AIS, had no history of AF, and had continuous observation no less than 1 year before the diagnosis of AIS (i.e., index date) as well as longer than 30 days after the index date. The study period is a 10-year period from January 1, 2009 to December 31, 2018. The exposure of interest are treatment of Non-vitamin K antagonist oral anticoagulants (NOACs), warfarin, P2Y12 inhibitors, and individual or combination agents that include aspirin. The outcome of interest is recurrent event of ischemic stroke. Statistical analyses include descriptive statistics for baseline demographics, comorbid conditions, procedures, and medication use of patients prior to the index date, percentage of various antiplatelet and anticoagulation treatment and treatment pathway on and within 30 days after the index date, average of continuous antithrombotic treatment duration, and the incidence of recurrent ischemic stroke event within 1 year after the index date and also during the entire observation.
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Assessment of burden of illness of heart failure with reduced ejection fraction in the United Kingdom — Jennifer Quint ...
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Assessment of burden of illness of heart failure with reduced ejection fraction in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-05-10
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Laura Portas - Corresponding Applicant - Imperial College London
Anina Fraschke - Collaborator - Bayer AG
Bernard Wilson - Collaborator - Bayer AG
Martin Cowie - Collaborator - King's College London (KCL)
Niklas Schmedt - Collaborator - Bayer AGOutcomes:
- Incidence and prevalence of HF, HFrEF and preserved ejection fraction (HFpEF) in a UK population-based cohort, including all the patients meeting minimum age of 18 years and data quality requirements
- Drug treatment patterns in patients with HFrEF
- RiDescription: Technical Summary
The study population will be determined using events from both primary care and linked data sources (HES and ONS). In addition to providing information on healthcare resource use, the HES data will be used to assess baseline comorbidity burden and to determine outcomes. Data from ONS will be used to get information on date and cause of death.
A Âpopulation-based cohortÂ, including all the patients meeting minimum age and data quality requirements, will be used to calculate the incidence and prevalence of HF, HFrEF and HFpEF for each year between 2008 and 2018.
The ÂHFrEF cohort represented by patients with HFrEF will be followed from the time of incident HFrEF diagnosis (index date) until the first of the following events: disenrollment from practice or from CPRD, death, end of the study period or occurrence of the respective outcome.
In a further analysis, all outcomes will be assessed: from index date to first worsening event (i.e. HF hospitalisation), from 1st to 2nd, from 2nd to 3rd, from 3rd to 4th and from 4th to 5th worsening event.
Finally, a Âworsening HFrEF cohort with three mutually exclusive subpopulations will be selected to assess the generalizability of the clinical trial.
Descriptive statistics will be calculated using the denominator with non-missing values. Incidence rate of clinical outcomes, HF-related complications and safety outcomes will be calculated per 10,000 person-years. 95% confidence intervals (95% CI) will be estimated using a Poisson distribution. For the HFrEF and the worsening cohort, incidence rates will be calculated over the study period as well as yearly. The risk and 95% CI for individual complications of HFrEF will be estimated using Kaplan-Meier estimators. For the inpatient/outpatient encounters, we will estimate an HRU rate per 100 person-years for each measure and the 95% CI using a Poisson distribution.
Source -
To use machine learning to rapidly understand the current treatment pathway for patients with hypercholesterolaemia and what are the factors associated with optimal management of these patients in line with established best practice NICE guidance — Imperial College Health Partners...
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To use machine learning to rapidly understand the current treatment pathway for patients with hypercholesterolaemia and what are the factors associated with optimal management of these patients in line with established best practice NICE guidance
Legal basis:De-identified Data Access Request
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request. COMMERCIAL
Source -
Targeting non-diabetic hyperglycaemia: evaluation of the Diabetes Prevention Programme (DPP) in North West London (NWL) — Imperial College Health Partners...
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Targeting non-diabetic hyperglycaemia: evaluation of the Diabetes Prevention Programme (DPP) in North West London (NWL)
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request:. Academic
Source -
o examine the levels and primary types of multi-morbidity in Northwest London that stem from diabetes, pre-diabetes, hypertension, and depression and to assess the sub-populations at high risk for multimorbidity that are being served by NW London lifestyle change initiatives (National Diabetes Prevention Program and REWIND- diabetes remission programs) — Imperial College Healthcare NHS Trust...
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o examine the levels and primary types of multi-morbidity in Northwest London that stem from diabetes, pre-diabetes, hypertension, and depression and to assess the sub-populations at high risk for multimorbidity that are being served by NW London lifestyle change initiatives (National Diabetes Prevention Program and REWIND- diabetes remission programs)
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: De-identified Data Access Request:. Commercial
Source -
De-identified Data Access Request – PHM Inequalities — Imperial College Health Partners...
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De-identified Data Access Request – PHM Inequalities
Legal basis:De-identified Data Access Request
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: missing. Commercial
Source -
RADAR (Risk Algorithms for Decision support and Adverse outcomes Reduction) — Imperial College Health Partners...
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RADAR (Risk Algorithms for Decision support and Adverse outcomes Reduction)
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request:. Academic
Source -
Quality of secondary prevention following percutaneous coronary interventions in De-identified Discover North West London cohort — Imperial College Health Partners...
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Quality of secondary prevention following percutaneous coronary interventions in De-identified Discover North West London cohort
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request:. Commercial
Source -
De-identified Data Access Request: 6 Months Extension: Targeting non-diabetic hyperglycaemia (pre-diabetes): evaluation of the Diabetes Prevention Programme (DPP) in North West London (NWL) — Imperial College Health Partners...
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De-identified Data Access Request: 6 Months Extension: Targeting non-diabetic hyperglycaemia (pre-diabetes): evaluation of the Diabetes Prevention Programme (DPP) in North West London (NWL)
Legal basis:De-identified Data Access Request: 6 Months Extension:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: missing. Commercial
Source -
To support transformation, financial recovery and business planning including working towards ICPs/ICSs. — Imperial College Health Partners...
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To support transformation, financial recovery and business planning including working towards ICPs/ICSs.
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request:. Commercial
Source
2020 - 04
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The effect of air pollution on health and mortality — unknown...
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The effect of air pollution on health and mortality
Where: unstated
When: 2020-4-28
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Background
Ambient air pollution is the biggest environmental threat to public health in the UK. Research suggests that the breathing of polluted air is associated with the development and exacerbation of various health conditions, and the cost of treating such conditions is substantial.
Aims & Key Questions
This project investigates the effects of air pollution on mortality and a range of morbidity outcomes, as well as birth outcomes. The project links pollution data to various individual-level datasets for Northern Ireland (NI), including multiple years of census data, prescriptions records and birth records, and focuses on the effects of fine particulate matter pollution (PM2.5), considered to be the most harmful pollutant for human health. It first estimates the impact of long-term exposure on various self-reported health outcomes among adults, and then investigates the link with mortality. Focussing on children, it assesses air pollution effects on childhood asthma and other breathing difficulties. Focusing on older age groups, it also assesses whether there is a relationship with the development of Parkinsonism and dementia. Additionally, the project examines the effect of maternal exposure to ambient air pollution during pregnancy on birth outcomes. An additional aim of this project is to raise awareness about the levels and effects of air pollution in NI among policymakers and the public. To achieve this goal, an online air pollution dashboard for NI will be used, and this will be updated and expanded to include the latest data as it becomes available.
Data
Northern Ireland Longitudinal Study (NILS), NISRA Distinct linkage of NILS to the Enhanced Prescribing Database (EPD), HSC Business Services Organisations Northern Ireland Maternity Services (NIMATS), HSC Business Services Organisations Modelled air pollution background concentration data, Department for Environment, Food and Rural Affairs (DEFRA)In the Northern Ireland Longitudinal Study (NILS) data, individual-level health metrics encompass self-reported health status from the 2011 Census and mortality events documented by the General Register Office (GRO) for Northern Ireland. By linking the NILS with the Enhanced Prescribing Database (EPD), prescription records sourced from routinely collected administrative data become available for analysis, including GP-dispensed medications for treating cardiovascular and respiratory illnesses, dementia, Parkinsonism, and diabetes.
Pollution exposure is quantified by the annual average ambient air pollution levels at an individual's area of residence, using data modelled for DEFRA at a 1x1 km grid square resolution for up to eight pollutants spanning the years 2001 to 2019. This allows the construction of cumulative pollution exposure measures for individuals in the study.
Additionally, these pollution data will also be linked to data from the Northern Ireland Maternity Service (NIMATs), which provides a wealth of demographic and clinical information on mothers and infants, encompassing factors such as infant birth weight and the mother's medical and obstetric history. Maternal exposure to pollution is determined by the annual average ambient air pollution levels at the mother's postcode address during pregnancy.
The combination of these linked datasets offers a robust framework for exploring the intricate relationship between individual health, prescriptions, and the impact of ambient air pollution in Northern Ireland from 2001 to 2016.
Potential
This project aims to provide the first comprehensive estimates of the individual-level health costs associated with air pollution in NI, considering a diverse range of health outcomes applicable to all stages of the life course.
Leveraging linked prescriptions data, the study will examine the effects of pollution exposure on childhood respiratory illness together with lesser studied health conditions such as diabetes, dementia, and Parkinsonism among adults. Furthermore, the investigation delves into whether infants born to mothers residing in areas with higher pollution levels during pregnancy experience earlier births and lower birth weights compared to those in less polluted areas, aligning with the policy objectives outlined in the Northern Ireland Draft Programme for Government, which prioritize improving air quality and birth outcomes.
Overall, this project serves to inform policymakers on the extent of air pollution reductions necessary to enhance population health in the region.
The Updates
The research team has developed an interactive air pollution map of Northern Ireland which allows users to explore how levels of air pollution in their local area have changed through time and how they compare to pollution levels in other parts of Northern Ireland. This tool empowers the public to understand the levels of air pollution in their communities and how this could impact their lives. A Data Insight on The Effect of Exposure to Air Pollution on Health and Mortality was published early in the life of the project. A working paper examining the effects of in utero PM2.5 exposure on infant health was published in 2022. This paper provides the first assessment of infant health effects for NI. A working paper examining the effects of long-term PM2.5 exposure on self-reported health in adults was published in 2024. This paper provides the first assessment of health effects for adults in NI.Project Details
Project Lead: Prof Duncan McVicar
Project Team: Dr Babak Jahanshahi, Dr Corina Miller, Dr Mark McGovern, Dr Neil Rowland and PhD Jason Fleming
Steering Group Members: NI Department of Health, NI Department of Agriculture, Environment and Rural Affairs, Belfast City Council, British Heart Foundation, Asthma + Lung UK and Alzheimer's Society.
Duration: Due for completion in 2026
Contact: ni@adruk.org
Funding: This project is funded by ADR NI via its core grant from the Economic & Social Research Council (ESRC) as an ADR UK partner.
Source -
The effect of air pollution on health and mortality —
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The effect of air pollution on health and mortality
Where: unstated
When: 2020-4-28
Opt Outs: no information provided./p>
Who: Professor Duncan McVicar, Queenâs University Belfast (ADR Northern Ireland).
Datasets:see text
Why:
This project will investigate the effect of ambient air pollution exposure on health in Northern Ireland.
Source -
School-level attainment gaps and the Pupil Deprivation Grant — unknown...
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School-level attainment gaps and the Pupil Deprivation Grant
Where: unstated
When: 2020-4-23
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project will consider whether there is an association between the Pupil Deprivation Grant (PDG) and school-level attainment gaps Wales. The project will explore the types of interventions that schools have implemented, and attainment outcomes at both Key Stage 2 and Key Stage 4.
Source -
Infant health and mothersâ exposure to air pollution —
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Infant health and mothersâ exposure to air pollution
Where: unstated
When: 2020-4-28
Opt Outs: no information provided./p>
Who: Professor Duncan McVicar, Queenâs University Belfast (ADR Northern Ireland).
Datasets:see text
Why:
This project will investigate the effect of maternal exposure to ambient air pollution during pregnancy on birth outcomes in Northern Ireland.
Source -
The relationship between social exclusion and educational attainment —
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The relationship between social exclusion and educational attainment
Where: unstated
When: 2020-4-28
Opt Outs: no information provided./p>
Who: Professor Duncan McVicar, Queenâs University Belfast (ADR Northern Ireland).
Datasets:see text
Why:
This project will use the National Pupil Database (NPD) to investigate the relationship between exclusions and educational attainment. The NPD holds a wide range of information about pupils attending schools and colleges in England, including demographic information at the pupil level, various data on school characteristics, pupil exclusion and absence histories, and pupil attainment records from Key Stage 1 (age 7) to Key Stage 5 (age 18). Importantly, the data is longitudinal, allowing for the anonymous recording of pupils during their primary- and secondary-level education.
Source -
The relationship between school exclusion and educational attainment — Project Lead:
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The relationship between school exclusion and educational attainment
Where: unstated
When: 2020-4-28
Opt Outs: no information provided./p>
Who: Project Lead: Professor Duncan McVicar, Queenâs University Belfast (ADR Northern Ireland).
Datasets:see text
Why:
This project will use the National Pupil Database (NPD) to investigate the relationship between exclusions and educational attainment. The NPD holds a wide range of information about pupils attending schools and colleges in England, including demographic information at the pupil level, various data on school characteristics, pupil exclusion and absence histories, and pupil attainment records from Key Stage 1 (age 7) to Key Stage 5 (age 18). Importantly, the data is longitudinal, allowing for the anonymous recording of pupils during their primary- and secondary-level education.
Source -
Covid-19 Testing Results (Identifiable) (Secondary Uses) — Public Health England...
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Covid-19 planning, commissioning and research purposes. — IG-00512
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 21/04/2020
Purpose for which the data is being used: Covid-19 planning, commissioning and research purposes.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
National Data Opt-out Applied: Not Applied â Legal obligation overrides & in Public Interest.
Source -
SUS+ data â Admitted Patient Care
(Identifiable) (Secondary Uses) — Public Health England ...
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For the purposes of public health monitoring and profiling hospital admissions for Lower Respiratory Tract Infections related to Covid-19. — IG-00232
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 01/04/2020
Purpose for which the data is being used: For the purposes of public health monitoring and profiling hospital admissions for Lower Respiratory Tract Infections related to Covid-19.
Dataset: SUS+ data â Admitted Patient Care
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: COPI Regulations
Common Law Duty of Confidentiality: COPI Regulations
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task. GDPR Article 9(2)(g) â Substantial public interest. GDPR Article 9(2)(h) â Healthcare purposes. GDPR Article 9(2)(i) â Public health purposes. DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose. DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes. DPA 2018 Part 1 Schedule 1 para 3 â Public health.
National Data Opt-out Applied: Not Applied â Legal obligation overrides & in public interest.
Source -
Shielded Patient List (SPL) (Identifiable) (Direct Care ) — GP Practices...
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The Shielded Patient List (SPL) is shared with GP practices and NHS trusts in order that they identify relevant patients who need advice on shielding and to validate that they should be on the SPL. — IG-00310
Recipient Data Controller Organisation(s) : GP Practices NHS Trusts
Approval Date: 08/04/2020
Purpose for which the data is being used: The Shielded Patient List (SPL) is shared with GP practices and NHS trusts in order that they identify relevant patients who need advice on shielding and to validate that they should be on the SPL.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice & Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice & Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(d) â Vital interests GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Not Applied â Direct Care.
Source -
Covid-19 Testing Results (Identifiable) (Direct Care and Secondary Uses) — Department of Health Northern Ireland ...
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The data will be used by the Public Health Agency for patient tracing, analysis, and data linkage purposes. It will enable individuals to be contacted to inform them whether they have Covid-19 and should be self-isolating, to provide additional information about healthcare. The data will also be used for COVID19 related planning, commissioning, and research purposes. — IG-00511
Recipient Data Controller Organisation(s) : Department of Health Northern Ireland
Approval Date: 30/04/2020
Purpose for which the data is being used: The data will be used by the Public Health Agency for patient tracing, analysis, and data linkage purposes. It will enable individuals to be contacted to inform them whether they have Covid-19 and should be self-isolating, to provide additional information about healthcare. The data will also be used for COVID19 related planning, commissioning, and research purposes.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care and Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(4) Health and Social Care Act 2012 section 261(5)(c) Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: Health and Social Care Act 2012 section 261(4) Health and Social Care Act 2012 section 261(5)(c) Health and Social Care Act 2012 section 261(5)(d)
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: Health and Social Care (Reform) Act (Northern Ireland) 2009 - Section 2(1) Health and Social Care (Reform) Act (Northern Ireland) 2009 - Section 2(3)(g) Health and Social Care (Reform) Act (Northern Ireland) 2009 - Section 3(1)(b)
Common Law Duty of Confidentiality: Health and Social Care (Reform) Act (Northern Ireland) 2009 - Sections 2 Health and Social Care (Reform) Act (Northern Ireland) 2009 - Sections 3 Health and Social Care (Reform) Act (Northern Ireland) 2009 - Sections 13
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â The national data opt out does not apply outside England.
Source - and 34 more projects — click to show
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Demographic and Child Protection Order (CPO) data extracted from the national CP-IS system. (Identifiable) (Direct Care) — 0...
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Used by School Nurses and Health Visitors to ensure the health and safeguarding of children with a statutory protection plan during the period of heightened risk resulting from the Covid-19 pandemic. — IG-00294
Recipient Data Controller Organisation(s) : 0-19 Services Providers commissioned to deliver childrens health services by Local Authorities
Approval Date: 17/04/2020
Purpose for which the data is being used: Used by School Nurses and Health Visitors to ensure the health and safeguarding of children with a statutory protection plan during the period of heightened risk resulting from the Covid-19 pandemic.
Dataset: Demographic and Child Protection Order (CPO) data extracted from the national CP-IS system.
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Direct Care.
Source -
Covid-19 Testing Results (Identifiable) (Secondary Uses) — National Services Scotland ...
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Covid-19 planning, commissioning and research purposes. — IG-00509
Recipient Data Controller Organisation(s) : National Services Scotland
Approval Date: 21/04/2020
Purpose for which the data is being used: Covid-19 planning, commissioning and research purposes.
Dataset: Covid-19 Testing Results
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(d) and Health and Social Care Act 2012 section 256(2)(c)
Common Law Duty of Confidentiality: Public Interest
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
Statutory Authority: Public Health Scotland Order 2019 (section 4(2)(d)) National Health Service (Scotland) Act 1978
Common Law Duty of Confidentiality: Public interest Public Health Scotland Order 2019 (section 4(2)(d)) National Health Service (Scotland) Act 1978
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose GDPR Article 9(2)(i) â public health purposes, plus Part 1, Sched 1 DPA18, para 3 public health
National Data Opt-out Applied: Not Applied â The national data opt out does not apply outside England
Source -
NHS 111
(Pseudonymised ) (Secondary Uses) — Public Health England ...
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Daily syndromic surveillance is carried out by Public Health England to provide a near-real-time view of community morbidity to support the management of COVID19 infectious disease activity and to manage the COVID19 public health emergencies. — IG-00314
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 03/04/2020
Purpose for which the data is being used: Daily syndromic surveillance is carried out by Public Health England to provide a near-real-time view of community morbidity to support the management of COVID19 infectious disease activity and to manage the COVID19 public health emergencies.
Dataset: NHS 111
Category of Data: Pseudonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: COPI Regulations
Common Law Duty of Confidentiality: COPI Regulations
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Substantial public interest. DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose.
National Data Opt-out Applied: Not Applied â Legal obligation overrides & in public interest.
Source -
Hospitalisation in England Surveillance System (CHESS) data (Aggregate (small numbers not supressed)) (Secondary Uses) — Lancashire Teaching Hospitals NHS Foundation Trust...
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Pilot dashboard to enable accurate critical care capacity planning by NHS trusts during the Covid-19 pandemic. NHSE/I will use for regional and national based capacity planning. PHE will use the data for data quality reporting and publication of national statistics, in partnership with NHS Digital. Department of Health and Social Care may use the national level outputs from the CPAS reporting tool for national planning purposes and to support the daily public press briefings. — IG-00421_1
Recipient Data Controller Organisation(s) : Lancashire Teaching Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Cambridge University Hospitals NHS Trust Kings College Hospital NHS Foundation Trust Public Health England NHSE/I Department of Health and Social Care
Approval Date: 17/04/2020
Purpose for which the data is being used: Pilot dashboard to enable accurate critical care capacity planning by NHS trusts during the Covid-19 pandemic. NHSE/I will use for regional and national based capacity planning. PHE will use the data for data quality reporting and publication of national statistics, in partnership with NHS Digital. Department of Health and Social Care may use the national level outputs from the CPAS reporting tool for national planning purposes and to support the daily public press briefings.
Dataset: Hospitalisation in England Surveillance System (CHESS) data
Category of Data: Aggregate (small numbers not supressed)
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice â NHS Trusts, PHE & DHSC COPI Regulations â NHSE/I
Common Law Duty of Confidentiality: General COPI Notice â NHS Trusts, PHE & DHSC COPI Regulations â NHSE/I
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation - NHS Trusts, PHE & DHSC GDPR Article 6(1)(e) â Public task - NHSE/I GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Legal obligation overrides and Aggregate Data.
Source -
Hospitalisation in England Surveillance System (CHESS)
Second Generation Surveillance System (SGSS)
SUS+
PDS (Identifiable) (Secondary Uses) — NHS Blood and Transplant Service ...
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Sharing of contact details for patients who fit the criteria for collection of convalescent plasma which is being explored as a possible treatment for Covid-19 with NHS Blood and Transplant (NHSBT) — IG-00404
Recipient Data Controller Organisation(s) : NHS Blood and Transplant Service
Approval Date: 17/04/2020
Purpose for which the data is being used: Sharing of contact details for patients who fit the criteria for collection of convalescent plasma which is being explored as a possible treatment for Covid-19 with NHS Blood and Transplant (NHSBT)
Dataset: Hospitalisation in England Surveillance System (CHESS) Second Generation Surveillance System (SGSS) SUS+ PDS
Category of Data: Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice Health and Social Care Act 2012 section 261(5)(d)
Common Law Duty of Confidentiality: NHSD COPI Notice & Public Interest
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
Statutory Authority: General COPI Notice COPI NHSBT Statutory Functions
Common Law Duty of Confidentiality: General COPI Notice Public Interest
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) - Public Task GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(h) â Healthcare purposes DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 2 â Health or social care purposes
National Data Opt-out Applied: Applied â Voluntary Application.
Source -
Demographic (Pseudonymised and Identifiable) (Secondary Uses) — Department of Health and Social Care...
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Sharing of demographic details of patients in England with IPSOS MORI as a data processor for the Department of Health and Social Care to invite volunteers to participate in the REACT I Antigen Research Study carried out by Imperial College London to help the Government measure the prevalence of COVID-19. — IG-00502_1
Recipient Data Controller Organisation(s) : Department of Health and Social Care
Approval Date: 29/04/2020
Purpose for which the data is being used: Sharing of demographic details of patients in England with IPSOS MORI as a data processor for the Department of Health and Social Care to invite volunteers to participate in the REACT I Antigen Research Study carried out by Imperial College London to help the Government measure the prevalence of COVID-19.
Dataset: Demographic
Category of Data: Pseudonymised and Identifiable
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(j) â Scientific research DPA 2018 Part 1 Schedule 1 para 4 â Research
National Data Opt-out Applied: Not Applied â Demographic Data only which NDOP does not apply to.
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Investigating early diagnoses of patients with ankylosing spondylitis using machine learning: a predictive modelling study — Matic Meglic ...
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Investigating early diagnoses of patients with ankylosing spondylitis using machine learning: a predictive modelling study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-19
Organisations:
Matic Meglic - Chief Investigator - Novartis Pharma AG
Shruti Narasimham - Corresponding Applicant - Novartis Ireland Limited
Abigail White - Collaborator - Novartis UK
Borja Mato - Collaborator - Novartis Pharma AG
Chiara Perella - Collaborator - Novartis Pharma AG
Jonathan Doogan - Collaborator - Novartis Pharma AG
Mark Taylor - Collaborator - Novartis UK
Mark Tomlinson - Collaborator - Novartis UK
Paul Emery - Collaborator - University of Leeds
Paula Pamies - Collaborator - Novartis UK
Raj Sengupta - Collaborator - Royal National Hospital For Rheumatic Diseases
Ruediger Merkel - Collaborator - Novartis Pharma AGOutcomes:
The outcome of interest in this analysis is a precise and early diagnosis of Ankylosing Spondylitis (and axSpA). Read codes for this are provided in Appendix A. Since this is a predictive analysis study, outcomes to be measured include (but are not limited to) accuracy, sensitivity, specificity, precision-recall, F1-score, positive and negative predictive values of the model as applied to the categorized patient and control population.
Description: Technical Summary
Objectives:
Although ~200,000 people in the UK have Ankylosing spondylitis (AS), a spinal inflammatory disease, it is an underdiagnosed condition(Dean et al., 2014). Symptoms usually start in the teens/twenties but it can take ~10 years for patients to receive an accurate diagnosis and treatment plan. This is due to a number of factors such as the existence of symptoms, which have a broad prevalence in the general population (like back pain), a gradual onset of the disease and the lack of unique biomarkers and clear guidelines for rheumatology referrals. Delayed diagnosis is a major impediment to treatment, disease characterization, policy-making, and resource allocation. This may be overcome by the analysis of electronic health records via predictive modelling.Building predictive models may be particularly useful to assimilate vast information and detect patterns across patient health records in order to provide valuable insight into disease management. We will use the CPRD, Hospital Episode Statistics (HES) and Office for National Statistics (ONS) data to identify predictors among the AS patient population that differentiate them from a non-AS control population. HES and ONS data will be used in conjunction with CPRD to gather insights into the diagnostic journey of AS patients by analysing patterns in hospitalisations, outpatient consultations, referrals, clinical procedures performed, accident and emergency visits, cause of death and treatment specialty.
Methods:
Machine learning will be used to capture features and patterns in patient characteristics that differentiate AS patients from controls across the database, and then predict an AS diagnosis, based on these features. Accuracy, precision, Receiver Operating Characteristic (ROC) curves will be computed for the trained and tested models.Data analysis:
Patients recorded with a diagnosis of AS from 01/01/2005 to 31/12/2018 will be the cohort analysed in this study.
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A retrospective cohort study to describe primary and secondary healthcare use and associated costs, and patterns of investigation and treatment in adult patients with chronic cough in the United Kingdom — Haya Langerman ...
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A retrospective cohort study to describe primary and secondary healthcare use and associated costs, and patterns of investigation and treatment in adult patients with chronic cough in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-27
Organisations:
Haya Langerman - Chief Investigator - Merck Sharp & Dohme - UK
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
- Collaborator -
Craig Currie - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Surinder Birring - Collaborator - King's College London (KCL)Outcomes:
Primary and secondary healthcare resource use and associated costs; investigations undertaken in primary and secondary care; drug initiations following presentation of chronic cough and subsequent outpatient attendances; outpatient referral and attendance patterns
Description: Technical Summary
This retrospective cohort study builds on an approach developed in a precursor study in order to discover chronic cough in CPRD data, given that it may not be recorded as such and the difficulty in distinguishing it from repeated acute cough. In the earlier study, we selected adult patients with at least one cough event (cough, cough remedy, or respiratory tract infection) in the study year (March 2014 to February 2015) and characterised their cough over the study year as acute or chronic, taking into consideration any cough events in the prior and subsequent year. In this study, we will describe and cost healthcare resource use and associated costs over this study year. In adults with incident chronic cough episodes, we will describe outpatient attendances and investigations before and after episode presentation, and drug initiations following the presentation of incident and succeeding episodes and subsequent outpatient attendances. Data will be summarised using descriptive statistics.
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Examining the clinical and economic outcomes associated with cancer survivorship — Li...
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Examining the clinical and economic outcomes associated with cancer survivorship
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-19
Organisations:
Li-Chia Chen - Chief Investigator - University of Manchester
Yubo Wang - Corresponding Applicant - University of Manchester
Cheryl Jones - Collaborator - University of Manchester
Claire Higham - Collaborator - The Christie NHS Foundation Trust
Darren Ashcroft - Collaborator - University of Manchester
Douglas Steinke - Collaborator - University of Manchester
Katherine Payne - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Safwaan Adam - Collaborator - The Christie NHS Foundation Trust
Salina Tsui - Collaborator - The Christie NHS Foundation Trust
Sean Gavan - Collaborator - University of Manchester
Stuart Wright - Collaborator - University of Manchester
Teng-Chou Chen - Collaborator - University of Manchester
Victoria Chatzimavridou-Grigoriadou - Collaborator - The Christie NHS Foundation TrustOutcomes:
The primary outcome of this study is the incidence of mortality and morbidity associated with cancer (e.g. cancer-related and all-cause mortality; cancer progression, recurrence or metastasis of cancer) or development of other specific conditions, namely bone disorders (fractures, osteoporosis, osteopenia); diabetes and endocrine disorders (hypopituitarism, adrenal failure (Addison?s), Adrenocorticotropic hormone (ACTH) deficiency, hypogonadism, hypothyroidism).
The secondary outcomes of interests include the treatment strategies for patients with either breast or lung cancer (i.e. initial and subsequent treatments and the combinations of different treatment strategies), treatments for concomitant conditions, and medical resources use (e.g. referral, admission to accident and emergency; all-cause hospitalisation; secondary care outpatient visit; primary care visit; medicine prescriptions).Description: Technical Summary
With advances in cancer diagnosis and treatments, the life expectancy of people who experience cancer has significantly increased but the epidemiology of other chronic diseases after cancer treatment and associated the risk factors is still under-studied. In addition, an increasing number of patients are diagnosed with cancer at an older age (e.g. breast cancer) due to the ageing population and the growing innovative treatments applied to cancer care (e.g. for lung cancer) have resulted in marked increases in healthcare costs. Examining the clinical and cost effectiveness of different treatment strategies for cancer considering the age and cancer staging of patients will help to inform the future development of treatment stratification tools to optimise cancer treatments. This study aims to investigate the risk of bone fracture and endocrine disorders in patients surviving following the treatment of site-specific cancers and evaluate the treatment pathways and medical resource use in adult patients with lung and breast cancer. A retrospective matched cohort study design will be used to compare the incidence of bone fracture and endocrine disorders in cancer survivors and their age, gender and practice-matched controls (1:5 matching) and the association between different site-specific cancers and risks of bone fracture or endocrine disorder events will be estimated. Cox proportional hazard models will calculate the hazard ratios for each outcome comparing survival in cancer survivors and control patients. For those cohorts of patients with breast or lung cancers, we will examine other clinical outcomes (all-cause mortality and cancer-specific mortality, survival time) and health resource use taking account of different treatment strategies. Cox proportional hazards models will be used to analyse the mortality outcomes and generalized linear models will be used to analyse the costs by adjusting for relevant factors, such as cancer staging. The results will provide evidence to inform clinical decision-making in relation to treatment optimisation for cancer patients.
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Historic trends and future projections of the consultation incidence and prevalence of osteoarthritis and low back pain in England: estimates from the Clinical Practice Research Datalink — George Peat ...
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Historic trends and future projections of the consultation incidence and prevalence of osteoarthritis and low back pain in England: estimates from the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-07
Organisations:
George Peat - Chief Investigator - Keele University
Dahai Yu - Corresponding Applicant - Keele University
James Bailey - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Matthew Missen - Collaborator - Keele University
Ross Wilkie - Collaborator - Keele UniversityOutcomes:
Annual consultation incidence and prevalence of osteoarthritis and low back pain
Description: Technical Summary
Musculoskeletal disorders are the most common limiting long-term conditions in the UK, accounting for an estimated 22% of total morbidity burden in England and 12-14% of all primary care consultations in people aged 15 years and over. The rate at which patients present to primary care with these conditions is a potentially useful indicator of population health and healthcare demand.
Building on our prior studies, we will estimate the annual consultation incidence and prevalence of low back pain and osteoarthritis for the period 2000 to 2019. A series of sensitivity analyses will explore the impact of case definition and including secondary care diagnoses. We will then use Bayesian age-period-cohort methods to generate future projected estimates for the period 2020 to 2030. Finally, we will explore inequalities in the rate of presentation of these conditions to primary care by comparing the consultation incidence and prevalence estimates by area-level deprivation.
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Quantifying Bias in Epidemiological Studies on the Association Between Acetaminophen and Cancer 2 — Martijn Schuemie ...
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Quantifying Bias in Epidemiological Studies on the Association Between Acetaminophen and Cancer 2
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-15
Organisations:
Martijn Schuemie - Chief Investigator - Janssen US
Martijn Schuemie - Corresponding Applicant - Janssen US
Patrick Ryan - Collaborator - Janssen Research & Development LLCOutcomes:
37 negative control outcomes: Achilles tendinitis; Atrophic vaginitis; Breath smells unpleasant; Bronchiectasis;
Disorders of initiating and maintaining sleep; Ear problem; Erythema nodosum; Falls; Foot-drop; Ganglion and cyst of synovium, tendon and bursa; Hemangioma; Hydrocele; Hyperthyroidism; Impaired glucose tolerance; Impingement syndrome of shoulder region; Impotence; Incontinence of feces; Interpersonal relationship finding; Irregular periods; Irritability and anger; Joint stiffness; Loss of sense of smell; Mixed hyperlipidemia; Osteitis deformans; Panic attack; Perforation of tympanic membrane; Pes planus; Polymyalgia rheumatica; Premature menopause; Prolapse of female genital organs; Pure hypercholesterolemia; Respiratory symptom; Restless legs; Restlessness and agitation; Rosacea; Simple goiter; Skin sensation disturbance; Snapping thumb syndrome; Urinary symptoms4 outcomes of interest: Renal cell carcinoma; Primary liver cancer; Lymphoma; Multiple myeloma
Description: Technical Summary
A large number of epidemiologic studies have been conducted to examine whether use of acetaminophen predisposes to the occurrence of one or more forms of cancer. There are many limitations to many of these studies as noted earlier, including vulnerability to channeling, protopathic bias, and uncontrolled confounding. However, the magnitude of the bias resulting from these limitation remains unknown, hampering the interpretability of the results of these studies. Recent methodological developments have focused on using large sets of negative controls  exposure-outcome pairs where no causal effect is believed to exist  to measure the operating characteristics of study designs by observing to what extent these designs produce effect size estimates in line with the truth (that there is no effect for the negative controls).
Here we aim to emulate prior studies, while including negative controls to quantify residual bias in these study designs. These prior studies mostly followed a case-control designs, although some used a cohort design. We will mimic the design choices in these prior studies as best we can, including the mechanism by which controls were selected, how exposure was defined, as well as the covariates used to adjust for potential confounding. We define 8 variants of the case-control design, and 2 variants of the cohort design.
The 37 negative controls were used in a previous study,2 and were selected based on a lack of evidence in literature, product labels, and spontaneous reports, as well as a manual review by several clinicians. In addition to the negative controls we also include four cancer outcomes.
The negative controls will allow quantification of the error due to the limitations of these study designs. This quantification in turn can be used to help interpret study results by determining whether an observed effect size falls outside of what can be expected based solely on error (both systematic and random error).
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Underlying conditions in coronavirus (COVID-19) infection: definition, prevalence, mortality and understanding risk — Amitava Banerjee ...
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Underlying conditions in coronavirus (COVID-19) infection: definition, prevalence, mortality and understanding risk
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-26
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Laura Pasea - Corresponding Applicant - University College London ( UCL )
Aasiyah Rashan - Collaborator - University College London ( UCL )
Alvina Lai - Collaborator - University College London ( UCL )
Anika Cawthorn (formerly Oellrich) - Collaborator - University College London ( UCL )
Anoop Shah - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Evaleen Malgapo - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Johan Thygesen - Collaborator - University College London ( UCL )
Jurgita Kaubryte - Collaborator - University College London ( UCL )
Linghui Gong - Collaborator - University College London ( UCL )
Mehrdad Alizadeh Mizani - Collaborator - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Muhammad (Ashkan) Dashtban - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Nel Swanepoel - Collaborator - University College London ( UCL )
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Stefanie Mueller - Collaborator - University College London ( UCL )
Suliang Chen - Collaborator - University College London ( UCL )
Vaclav Papez - Collaborator - University College London ( UCL )
Yen Yi Tan - Collaborator - University College London ( UCL )Outcomes:
#NAME?
Description: Technical Summary
As countries around the world implement lockdown in the face of the COVID-19 epidemic, there are concerns about the sustainability and acceptability of such interventions. On 22 March the government announced that a life-changing intervention(shielding) was to be offered to 1.5million citizens in England who were extremely vulnerable, based on one of a wide range of serious health conditions, which is an historic development.
We aim to understand these underlying conditions using NHS records, specifically to: (i) develop and validate EHR phenotypes for each condition and share with the international research community on the HDR UK- CALIBER portal; (ii) estimate the age- and sex- specific prevalence of these conditions (iii) estimate age-, sex- and condition- specific background (pre-COVID-19) risk of 1-year mortality; (iv) estimate 1-year mortality risk under different assumptions of COVID-19 infection and (v) the importance of government policies regarding COVID-19 and social isolation interventions.
Using population-based linked primary and secondary care electronic health records in England (CPRD and HES, HDR UK - CALIBER), we will study underlying conditions defined by UK Public Health England COVID-19 guidelines (16 March 2020: Âhigh risk and 22 March 2020: Âextremely vulnerableÂ) in individuals of all ages from 1997-2017. Using previously validated phenotypes (openly available for each condition using ICD-10 diagnosis, Read, procedure and medication codes), we will estimate age- and sex-specific background and COVID-19-related 1-year mortality in each condition, assuming a range of potential impact of the emergency (compared to background mortality): relative risk 1 to 5, and a population infection rate of 0.0001-80%.
We will explore the co-design an online tool with patients, public, researchers, clinicians, policymakers and public health professionals to provide information about COVID-19-related policies, background risk of mortality and risk of COVID-related mortality. Subject to stakeholder feedback and iterative improvement, we will work with policy makers to explore implementation of the tool for public use to inform the public of their own risk of baseline and COVID-related mortality.
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Descriptive analysis of primary care consultations in England from 2000 to 2018 — Toby Watt ...
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Descriptive analysis of primary care consultations in England from 2000 to 2018
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-14
Organisations:
Toby Watt - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Zoe Firth - Collaborator - The Health FoundationOutcomes:
Primary care consultation rates  key variables are: age; sex; proximity to death; consultation type; practice staff role
Description: Technical Summary
This aim of this study is to produce summary statistics on the use of primary care. We will produce counts of the number of primary care consultations per year from 2000 to 2018 broken down by age, gender, proximity to death, consultation type and practice staff role.
The figures generated from this study will feed into a separate, larger project that is exploring trends in healthcare use in England since 2000 across a number of different services. Within that project, nested negative binomial regression models will be used to estimate the effect of different factors on the counts of activity in primary care. The dependent variable will be counts of consultations. The independent variables will include age (5-year age bands), gender, proximity to death (0-12 months, 12-24 months or greater than 24 months), consultation type and practice staff role.
The study will improve our understanding of the growth in primary care consultations and proportion of this growth that can be explained by changes in demography and morbidity. This in turn will help the development of further research in health policy and funding.
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Cardiovascular safety of SGLT2 inhibitors in type 2 diabetes: The effect of obesity — Samy Suissa ...
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Cardiovascular safety of SGLT2 inhibitors in type 2 diabetes: The effect of obesity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-14
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Karine Suissa - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Major adverse cardiac events including myocardial infarction, ischemic stroke, cardiovascular death
Hospitalization for heart failure
Arrhythmia
Diabetic ketoacidosis
Hypoglycaemia
All-cause mortalityDescription: Technical Summary
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of drugs used in the treatment of type 2 diabetes. Clinical trials have suggested that SGLT2i reduce the incidence of major adverse cardiac events (MACE) among patients with type 2 diabetes and either established cardiovascular disease or at high cardiovascular risk compared with placebo. However, when comparing obese and non-obese, their results were inconsistent. In addition, studies of drug metabolism suggest that obesity may alter the efficacy of certain medications. Nevertheless, the effect of obesity on the effectiveness of SGLT2 inhibitors in a real-world setting is unknown. Our objective is therefore to examine the effect of obesity on SGLT2 treatment effectiveness in a real-world setting. Using a new-user design, we will conduct a propensity score matched analysis comparing users of SGLT2i to users of dipeptidyl peptidase-4 (DPP-4) inhibitors for the following outcomes: MACE, the individual components of MACE (myocardial infarction, ischemic stroke, cardiovascular death), hospitalization for heart failure, arrhythmia, hypoglycaemia and all-cause mortality stratified by obesity level. Cox proportional hazards models will be used to estimate adjusted hazard ratios and corresponding 95% confidence intervals of the association between SGLT2i and DPP-4 inhibitor use and cardiovascular outcomes stratified by obesity. To reduce residual confounding, we will adjust for any imbalances between matched groups. In addition, we will adjust for history of outcome in the year prior to cohort entry. In addition to investigating the effects in stratified analyses by levels of obesity, we will also examine these with continuous BMI level using cubic splines. Secondary analyses will consist of comparison of our results across categories of sex, age, history of heart disease and SGLT2i drug classes.
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Investigating the feasibility of exploring health outcomes among caregivers in a primary care database — Juliana Onwumere ...
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Investigating the feasibility of exploring health outcomes among caregivers in a primary care database
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-14
Organisations:
Juliana Onwumere - Chief Investigator - King's College London (KCL)
Alex Dregan - Corresponding Applicant - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)Outcomes:
The primary outcomes will include incidence of common physical and mental disorders including diabetes, cardiovascular disease, rheumatoid arthritis, cancer, hypertension, depression, dementia, and anxiety.
Description: Technical Summary
Aims: To explore the feasibility of determining the health status of mental health carers in primary care.
Objectives: We plan to compare differences in the incidence and prevalence of common health disorders between carers of people with physical disorders, carers of those with mental disorders and matched non-carer controls. To assess carer mortality, we will link CPRD with the ONS Death registration, and deprivation data. This would support adjustment for the potential influence of socioeconomic deprivation on the association between carer status and risk of physical or mental disorders.
Study design: A matched prospective cohort study where patients, identified as carers, will be examined and compared with non-carer controls (matched for age, gender, and practice) and within the carer group.
Methods: Cox proportional hazards will be used to assess time to event association between caring status with multiple disorders events incidence and all-cause mortality after adjusting for covariates. A multiple outcomes model will be employed which allows for the development of different outcomes in an unordered fashion.
Primary exposure: Carer status (carer vs no carer), as determined via Read or SNOMED codes terminology. If feasible in CPRD, a secondary exposure variable will be developed to classify carers into carers of people with a physical or mental disorder. An index of carer support will also be calculated as days of care delivered per year by caregivers per 1000 dependent persons, and average number of years of care by each caregiver.
Outcomes: These will be the most common physical and mental health disorders including diabetes, cardiovascular disease, rheumatoid arthritis, cancer, hypertension, depression, anxiety, dementia, insomnia, and pain. Carer mortality will also be measured.
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Proton Pump Inhibitors and Gastric Cancer Incidence: A Population-based Cohort Study — Samy Suissa ...
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Proton Pump Inhibitors and Gastric Cancer Incidence: A Population-based Cohort Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-21
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Alan Barkun - Collaborator - McGill University
Devin Abrahami - Collaborator - McGill University
Emily McDonald - Collaborator - McGill University
Mireille Schnitzer - Collaborator - University Of MontrealOutcomes:
The primary outcome is incident gastric cancer, which will be identified using Read codes (Appendix I).
The secondary outcome will consider gastric-cardia and gastric non-cardia cancers, separately.
Description: Technical Summary
Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are commonly prescribed to manage several gastric conditions. While treatment guidelines suggest short treatment courses for most indications, recent evidence indicates that PPIs are increasingly being used inappropriately, either for longer periods than necessary or by individuals without an indication for use. This overuse is especially concerning in light of recent safety signals associated with the use of PPIs, including a potential association with gastric cancer. As gastric cancer is associated with poor survival, this safety issue is particularly contentious. While several observational studies previously attempted to investigate this safety signal, evidence remains limited by methodological flaws present in early studies, including confounding by indication, immortal time bias and time window bias. Thus, the objective of this large population-based cohort study is to assess whether the use of PPIs, in comparison to the use of H2RAs, is associated with gastric cancer.
To address this, we will assemble a cohort of patients newly treated with PPIs or H2RAs between 1990 (the first full year that both drugs were available) and 2018, with follow-up until 2019. New users of PPIs will be compared to new users of H2RAs, and all exposures will be lagged by one year for cancer latency. To control for confounding, we will reweigh the cohort using high-dimensional propensity scores, which will adjust for more than 200 potential confounders. Patients will be followed from one year after the date of their first prescription until an incident diagnosis of gastric cancer, one year after switch from PPI to H2RA or vice versa, death from any cause, end of coverage, or end of the study period (December 31, 2019), whichever occurs first. Cox proportional hazards models will be used to estimate weighted hazard ratios of incident gastric cancer, comparing PPIs to H2RAs.
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Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases — Massoud Toussi ...
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Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases
Datasets:GP data, CPRD Mother-Baby Link; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-29
Organisations:
Massoud Toussi - Chief Investigator - IQVIA ( IMS Health ) France
Peter McMahon - Corresponding Applicant - IQVIA Ltd
Eleanor Ralphs - Collaborator - IQVIA LtdOutcomes:
Pregnancies exposed to valproate; Effectiveness of the risk minimisation measures (RMMs); Compliance to elements of the Pregnancy Prevention Programme (PPP); outcomes of birth
Description: Technical Summary
Valproate and related substances are licensed to treat epilepsy and bipolar disorder in Europe. In 2014 PRAC concluded a review on the safety and efficacy of these in female children, women of child bearing potential (WCBP) and pregnant women. Consequently, restrictions on valproate use were applied and risk minimisation measures (RMM) were implemented. In February 2018 PRAC issued a recommendation including revised prescribing conditions in the product information, a Pregnancy Prevention Programme (PPP) and revised educational measures.
PRAC requested continuation of the ongoing drug utilisation study conducted in the UK, France, Germany, Spain, Sweden. The study primary objectives are to describe and compare the valproate prescribing practices in WCBP, proportion of patients where all PPP measurable elements are fulfilled, the count of incidence and characteristics of valproate exposed pregnancies, during the 3-year pre and post-implementation period of the new RMM. This is a non-interventional longitudinal retrospective cohort study. A cohort of patients initiating valproate will be defined with a pre- and post-study design. Prescription, demographic and diagnosis data will be used. The study population will include women 13-49 years with at least one prescription of valproate during the pre-defined periods. Exposure is defined as one or more valproate prescriptions during a study period. The following variables will be considered: patient age, use of medications related to valproate indication ever recorded before valproate initiation, prescriber specialty, as well as PPP-specific variables such as contraceptive use and pregnancy testing. In addition, information on exposed pregnancies and outcome will be provided. The analyses will be mainly descriptive where the quantitative variables described above will be statistically compared via StudentÂs t-test or Wilcoxon signed-rank sum test, whereas categorical variables - via Pearson Chi2 or FisherÂs exact test. No adjustment for multiple comparisons will be made. As appropriate, 95% confidence intervals will also be calculated.
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Assessing the long-term impact of infant rotavirus vaccination on the age-related risk of acute gastroenteritis and heterologous effects of vaccination in children: a cohort study — Daniel Hungerford ...
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Assessing the long-term impact of infant rotavirus vaccination on the age-related risk of acute gastroenteritis and heterologous effects of vaccination in children: a cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-27
Organisations:
Daniel Hungerford - Chief Investigator - University of Liverpool
Daniel Hungerford - Corresponding Applicant - University of Liverpool
Aidan Flatt - Collaborator - University of Liverpool
David Taylor-Robinson - Collaborator - University of Liverpool
Kate Fleming - Collaborator - University of Liverpool
Mara Violato - Collaborator - University of Oxford
Miren Iturriza-Gomara - Collaborator - University of Liverpool
Neil French - Collaborator - University of Liverpool
Nigel Cunliffe - Collaborator - University of Liverpool
Roberto Vivancos - Collaborator - Public Health England
Thomas Inns - Collaborator - University of Liverpool
Virginia Pitzer - Collaborator - Yale UniversityOutcomes:
Primary care AGE consultations
AGE hospitalisations
Primary care, outpatient and hospitalisation with a diagnosis of IBD
Primary care, outpatient and hospitalisation with a diagnosis of CD
Primary care, outpatient and hospitalisation with a diagnosis of T1DDescription: Technical Summary
Aim: To assess the long-term impact of rotavirus vaccination on acute gastroenteritis (AGE) disease and heterologous vaccine effects on type 1 diabetes (T1D), Inflammatory Bowel Disease (IBD) and coeliac disease (CD) in pre-school and primary school children.
Objectives:
To assess whether rotavirus vaccination:
1. has changed the age and severity distribution of AGE in early childhood;
2. has any impact on the prevalence of IBD and CD in children;
3. has any impact on the prevalence of T1D in children.Design: cohort study
Population: children <7 years of age, born between January 2000 and 31st December 2019.
Exposure: Rotavirus vaccination status.
Primary outcome: CPRD recorded primary care consultations for AGE and Hospital Episode Statistic recorded hospitalisation with AGE.
Secondary outcomes: IBD, CD and diagnosis of T1D.
Confounders and adjusters: DTaP/IPV/Hib/HepB vaccine status, socioeconomic deprivation, geography, GP, comorbidities.
Data analysis:
Outcome measures will be assessed in rotavirus vaccinated and unvaccinated children. A previously validated method will be used to balance comparator populations to account for bias in healthcare-seeking behaviours. We will describe cohort characteristics and compare disease rates in vaccinated and unvaccinated groups.Primary outcome: Age-stratified disease incidence will be calculated for hospitalisations and GP consultations and compared in vaccinated and unvaccinated populations. Mixture models will be used to compare density of disease episodes by age for a vaccinated vs unvaccinated populations. Flexible parametric survival models will be used to assess differences in time to first event (GP consultation or hospitalisation). Age-stratified interrupted time-series analysis will assess how incidence rates have changed by season post-vaccine introduction.
Secondary outcomes - Flexible parametric survival models will be used to assess the risk of T1D, IBD and CD in a vaccinated and unvaccinated cohort.
Hazard ratios and incidence rate ratios derived from the regression models will be used as a measure of vaccine impact.
Source -
Utilisation and safety of Glycopyrronium Bromide (GPB) oral solution for the treatment of sialorrhoea in children <18 years in the UK — Saad Shakir ...
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Utilisation and safety of Glycopyrronium Bromide (GPB) oral solution for the treatment of sialorrhoea in children <18 years in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-27
Organisations:
Saad Shakir - Chief Investigator - Drug Safety Research Unit
Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Sandeep Dhanda - Collaborator - Drug Safety Research Unit
Vicki Osborne - Collaborator - Drug Safety Research UnitOutcomes:
 Dosages and duration of GPB treatment
 Demographics of patients
 Prior medical history (reasons for consultations)
 Indications for prescribing GPB (reasons for consultations)
 Number of GP practices
 Reasons for consultations during primary care treatment to identify adverse events during treatment with GPB 1mg/5ml oral solution for patients with an indication of sialorrhoea (e.g. dry mouth, constipation, diarrhoea)
 Reasons for consultations after stopping treatment with GPB 1mg/5ml oral solution for patients with an indication of sialorrhoea
 Adverse events of interest will also include central nervous system effects (in particular behavioural effects), renal system effects (in particular urinary retention), respiratory effects (cough, pneumonia, respiratory infections), neurodevelopment effects, constipation and diarrhoeaDescription: Technical Summary
This cohort study will assess the use of oral solutions and oral tablets of GPB in children under 18 years of age and the safety profile of GPB 1mg/5ml oral solution during treatment. The study will also assess the prescribing of oral solutions and oral tablets of GPB in children under 18 years of age who have been diagnosed with sialorrhoea.
All patients that have been prescribed oral solutions and oral tablets of GPB, as well as patients who have been diagnosed with sialorrhoea (irrespective of GPB prescribing) will be examined. The safety profile of GPB 1mg/5ml oral solution during treatment for patients diagnosed with sialorrhoea will be analysed.
Categorical data will be presented as tabulations; continuous data will be described using appropriate summary statistics (mean/SD or median/IQR). Reasons for consultations will be tabulated using grouping based on clinical code levels to allow for patterns to be examined as individual recording variation may otherwise preclude signal detection. Incidence risks will be calculated for safety events.
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Exploring the relationship between NSAID prescribing and complications in patients with common infections — Beth Stuart ...
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Exploring the relationship between NSAID prescribing and complications in patients with common infections
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-29
Organisations:
Beth Stuart - Chief Investigator - University of Southampton
Beth Stuart - Corresponding Applicant - University of Southampton
Martin Gulliford - Collaborator - King's College London (KCL)
Michael Moore - Collaborator - University of Southampton
Paul Little - Collaborator - University of Southampton
Roderick P. Venekamp - Collaborator - University Medical Centre UtrechtOutcomes:
Primary outcome: Safety outcomes as previously identified in the REDUCE trial. These were: pneumonia, peritonsillar abscess, mastoiditis, intracranial abscess, empyema, scarlet fever, pyelonephritis, septic arthritis, osteomyelitis, meningitis, toxic shock syndrome and septicaemia, and LemierreÂs syndrome. We will also include cardiovascular complications including acute myocardial infarction
These safety outcomes will primarily be based on the data from CPRD clinical and referral files, which include hospital referrals and discharge letters. However, we are also requesting linked hospital data to allow us to obtain any complications that resulted in an inpatient stay.
Secondary outcome: Hospital utilisation (linked data); Reconsultation with respiratory illness within 4 and 12 weeks.
Description: Technical Summary
Respiratory tract infections are a common reason for consulting in primary care. Many are self-limiting with many patients being advised to self-manage at home and use analgesics such as paracetamol and ibuprofen for symptom relief.
However there is some evidence emerging that the use of NSAIDs during infections can be associated with poorer outcomes both in terms of longer illness duration and increased risk of complications. A review of the use of NSAIDs in community acquired pneumonia suggested that it was associated with longer hospital stay and a higher rate of pleuropulmonary complications. It has been associated with a higher rate of complications of pharyngitis, including peritonsillar abscess. An observational study in children with viral infection suggested a link with empyema risk. However this data has primarily been in the form of retrospective case-control studies. There is also data from two clinical trials in adults with respiratory tract infection suggesting increased complications and longer durations of illness.
But adverse outcomes are rare and large datasets are needed in order to truly detect whether there is indeed an association with NSAID use. This study proposes the use of CPRD data to explore whether there is an association between receiving a prescription for an NSAID and poor outcomes. We will undertake 2 cohort studies  one in RTI patients and one in UTI patients - to explore the relationship between NSAID prescribing and hospitalisation, death or reconsultation. Since complications are very rare, we will then undertake a nested case-control study to compare those who experience complications with those who do not, with respect to their NSAID exposure.
The primary outcome will be presented using the frequency and proportions experiencing a hospitalisation, death or reconsultation with new or worsening infection or illness in each NSAID prescribing group. We will compare these groups using a Poisson model using the person-time at risk as exposure. Given that there may be unmeasured confounding at the individual level and given that there is potential exposure to NSAIDs without a prescription, we will also conduct a practice-level analysis.
Source -
COVID-19 and drugs acting on the renin angiotensin system — Martin Gulliford ...
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COVID-19 and drugs acting on the renin angiotensin system
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-15
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Abdel Douiri - Collaborator - King's College London (KCL)
Ajay Shah - Collaborator - King's College London (KCL)
Charles Wolfe - Collaborator - King's College London (KCL)
Emma Rezel-Potts - Collaborator - King's College London (KCL)
Phil Chowienczyk - Collaborator - King's College London (KCL)
Vasa Curcin - Collaborator - King's College London (KCL)Outcomes:
Clinical diagnoses of COVID-19.
Record of pneumonia after COVID-19 record.
Record of sepsis or shock after COVID-19 record.
Record of acute kidney injury after COVID-19 record.
Hospital admission with COVID-19.
Mortality with COVID-19.Description: Technical Summary
The SARS-CoV-2 virus, which causes COVID19, interacts with the angiotensin-converting enzyme 2 (ACE2) receptor. Drugs acting on the renin-angiotensin system, including angiotensin receptor blockers (ARB) and angiotensin converting enzyme inhibitors (ACEI), are widely used in the treatment of high blood pressure and diabetes. This has raised concerns that these drugs might increase the risk of either patients acquiring COVID-19 or having worse outcomes when are infected. We are conducting two studies with data from hospital and community-based COVID-19 patients to test these hypotheses. We have discussed the signals from these studies with the MHRA, which recommended we conduct a third study using CPRD data. We will conduct a case-control study, nested within the cohort of CPRD patients who were ever prescribed antihypertensive drugs, to estimate whether ARBs or ACEIs are associated with higher odds of COVID-19 diagnosis. We will compare antihypertensive-treated COVID-19 patients with antihypertensive-treated controls matched for age, sex and general practice. The association with ARB/ACEI therapy will be evaluated using conditional logistic regression adjusting for confounders. We will conduct a cohort study of all patients diagnosed with COVID-19 to compare the incidence of pneumonia, sepsis, acute kidney injury or hospital admission, or mortality according to ACEI/ARB exposure. We will estimate hazard ratios using the proportional hazards model according to ARB/ACEI treatment allowing for confounding including age, comorbidity and co-prescribing. We are requesting access to linked HES data but we expect to report initial results using CPRD data only, because HES linkage takes time to complete. We acknowledge that the study has limitations because not all COVID-19 patients are recorded in general practice, with only a minority of the latter having confirmatory tests. Nevertheless, the results should be applicable to those with a clinical diagnosis.
Source -
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) Study — Tobias Gerhard ...
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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) Study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-19
Organisations:
Tobias Gerhard - Chief Investigator - Rutgers, The State University of New Jersey
Haoqian Chen - Corresponding Applicant - Rutgers, The State University of New Jersey
Avinash Gabbeta - Collaborator - Rutgers, The State University of New Jersey
Cecilia Huang - Collaborator - Rutgers, The State University of New Jersey
Daniel B. Horton - Collaborator - Rutgers Robert Wood Johnson Medical School
Edward Nonnenmacher - Collaborator - Rutgers, The State University of New Jersey
Kristyn Chin - Collaborator - Harvard Medical School
Madhav Thambisetty - Collaborator - National Institutes of Health - USA
Mary Ritchey - Collaborator - Rutgers, The State University of New Jersey
Mufaddal Mahesri - Collaborator - Harvard Medical School
Priscilla Winston-Laryea - Collaborator - Rutgers, The State University of New Jersey
Rishi Desai - Collaborator - Harvard Medical School
Sebastian Schneeweiss - Collaborator - Aetion, Inc
Vijay Varma - Collaborator - US-NIHOutcomes:
AlzheimerÂs disease; vascular dementia; senile, pre-senile, or unspecified dementia; and dementia in other diseases classified elsewhere.
Description: Technical Summary
There is an urgent need to discover effective treatments for AlzheimerÂs Disease (AD). Original research performed in the Unit of Clinical and Translational Neuroscience at the US National Institute of Aging Intramural Research Program (NIA IRP) has identified several molecular pathways that are associated with the severity of AD pathology in the brain and the expression of clinical symptoms. This research further identified several commonly used medications that interact with these pathways and thus may protect against AD. These medications are currently in use for several non-AD indications. Therefore, hypotheses of a potential protective role of these medications in AD can be tested (strengthened or refuted) using large-scale patient-level data collected during routine health care delivery, such as the CPRD. For each drug of interest, we will implement a new user, active comparator, observational cohort study (section L for a list of the 6 candidate drug/comparator pairs). This design will minimize confounding by indication through comparisons to drugs with a shared indication that do not share interactions with the pathways related to AD. The approach further allows us to capture the effect of drug exposure on dementia risk throughout the treatment course and to address other key biases common to observational studies of prevalent users. For each comparison, propensity scores will be calculated as the predicted probability of initiating the exposure of interest (i.e., the repurposing candidate) versus the reference exposure conditional on baseline patient characteristics using multivariable logistic regression models. Pair matching will be conducted using a nearest-neighbour algorithm. For each comparison, adjusted relative risk estimates will be obtained by computing the hazard ratios and 95% confidence intervals using a Cox proportional hazard regression model in the propensity score matched population.
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COVID-19 related risks in cancer survivors: a matched cohort study using linked UK electronic health records data — Krishnan Bhaskaran ...
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COVID-19 related risks in cancer survivors: a matched cohort study using linked UK electronic health records data
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-19
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Isabel dos-Santos-Silva - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Susannah Stanway - Collaborator - Royal Marsden HospitalOutcomes:
Aim 1: Prevalences of factors currently recognised as associated with high risk for severe COVID-19 outcomes by the UK government and Public Health England.
Aim 2: The primary outcome is influenza hospitalisation or mortality (composite outcome).
Description: Technical Summary
Older individuals and people with certain underlying health conditions are known to be at higher risk of having severe disease if they contract the novel COVID-19. People receiving active treatment for certain cancers (including lung, haematological) are among those considered high risk. But it is not known whether medium to long-term cancer survivors are at higher risk of severe outcomes if they catch the virus.
This study will investigate this using linked primary care, hospital, cancer registration and death certificate data. We will analyse a cohort of 1-year cancer survivors, matched to controls with no history of cancer. First, we will look at how common known risk factors for severe COVID-19, such as heart disease and respiratory disease, are in cancer survivors compared to people who have never had cancer. Second, we will conduct a time-to-event analysis to investigate whether cancer survivors are more likely than people who have never had cancer to be hospitalised or die from influenza. The second approach is based on the fact that there is likely substantial overlap between people at high risk of severe influenza, and people at high risk of severe COVID-19. Indeed, because COVID-19 is completely new, public health organisations have had to base many of their decisions about how to handle the disease on evidence from influenza.
Our study will add to the evidence informing public health organisations and government whether cancer survivors need to be considered high-risk as policies such as isolation and social distancing evolve.
Source -
Psychological distress associated with the current COVID-19 outbreak: evidence from electronic health records — Alex Dregan ...
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Psychological distress associated with the current COVID-19 outbreak: evidence from electronic health records
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-19
Organisations:
Alex Dregan - Chief Investigator - King's College London (KCL)
Alex Dregan - Corresponding Applicant - King's College London (KCL)
Fiona GAughran - Collaborator - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)
Matthew Hotopf - Collaborator - King's College London (KCL)
Robert Stewart - Collaborator - King's College London (KCL)Outcomes:
The study primary outcome will be mental distress and neurological symptoms, defined as the presence of
depression, anxiety, sleep problems, self-harm, cognitive impairment, seizures, unexplained pain, los of sensation. Several secondary outcomes will be investigated, including physical disability, quality of life (QoL), safety outcomes, healthcare utilisation, and all-cause mortality.Description: Technical Summary
Aims: Recent coronavirus disease (COVID-19) outbreak has so far affected a quarter of the world populations, from young children to older adults. Patients susceptible or diagnosed with COVID-19, their families, and health professionals are at increased risk of experiencing mental distress, including neurological symptoms. The proposed study aims to establish the epidemiology of mental distress among patients susceptible/isolated/diagnosed with COVID-19, and the impact of current care pathways on mental distress symptomatology and prognosis. Whenever feasible, these aims will be explored separately by gender, ethnicity, and socio-economic status (SES).
Primary exposures: COVID-19 susceptibility/isolation/infection diagnoses and corticosteroids treatment.
Outcomes: Primary study outcome will be incidence mental distress (including neurological symptoms) events during the study period. In addition, the study will estimate COVID-19 related outcomes, including physical impairment, poor quality of life, healthcare utilisations, and all-cause mortality.
Study design: Prospective matched cohort study, including a nested case-control study.
Methods: Multivariable longitudinal analyses will be implemented using several statistical techniques, including, Cox proportion hazards regression, linear mixed effects models, and conditional logistic regression.
Linked datasets: ONS Death registration data, Index of Multiple Deprivation (practice and patient level).
Findings: The proposed study will provide novel insights into the mental and neurological distress associated with the current COVID-19 pandemic. It will also identify the impact that COVID-19 burden has on vulnerable subgroups and healthcare professionals mental distress. Such information will inform the development of preventive and control strategies associated with future infectious outbreaks.
Source -
Incidence and treatment of anxiety and depression in patients and families after a cancer diagnosis: a descriptive population-based study — Ruth Brauer ...
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Incidence and treatment of anxiety and depression in patients and families after a cancer diagnosis: a descriptive population-based study
Datasets:GP data, NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-14
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Man-Chie Chow - Corresponding Applicant - Royal Surrey NHS Foundation Trust
Ian Wong - Collaborator - UCL School Of Pharmacy
Martin Forster - Collaborator - University College London ( UCL )
Pinkie Chambers - Collaborator - University College London ( UCL )Outcomes:
Primary care diagnoses (READ codes) of anxiety and depression in cancer patients; GP prescription rates of anxiolytics and anti-depressants in cancer patients; Primary care diagnoses (READ codes) of anxiety and depression in direct family members of cancer patients; prescription rates of anxiolytics and anti-depressants in direct family members
Description: Technical Summary
Anxiety and depression commonly occur in people with cancer. Patients with cancer and comorbid depression have higher levels of anxiety, pain, fatigue and functioning than other patients with cancer, overall negatively affecting their quality of life. Depression, either before or after a cancer diagnosis, is also known to be a risk factor for cancer mortality.
Our aim is to describe the incidence and pharmacological treatment of anxiety and depression within a cohort of patients with a diagnosis of cancer. The population will also include children with a cancer diagnosis. Survival rates in childhood cancers are high, with a 5-year survival rate of 83% for those diagnosed in 2008-2012 and the management of co-morbidities, like depression, are important.
Previous small studies have shown that the mental wellbeing of family members and caregivers of patients with cancer is affected negatively by a cancer diagnosis, which, in turn, can affect the long term physical health of the cancer patients. We also aim to describe the incidence and treatment of anxiety and depression in family members. Family members will be selected through a Âfamily number identifierÂ. Descriptive statistics will be used to calculate incidence rates of anxiety and depression 25 types of cancer, and to calculate the proportion of cancer patients who receive antidepressants and/or anxiolytics following a cancer diagnosis.
Cancer is rapidly becoming a chronic disease for an increasing number of people; in the UK alone more than 3 million people are expected to have a diagnosis of cancer by 2030. Population-based estimates of the incidence and treatment of anxiety and depression among cancer patients as well as their family members, will provide clinicians and other stakeholders more understanding of the scale of the problem. The results of the study can be used to prioritise and guide further work.
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Resource burden and treatment pathway for Type 2 Diabetic patients with Diabetic Kidney Disease in England: A study utilising primary and secondary care datasets — Jay Were ...
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Resource burden and treatment pathway for Type 2 Diabetic patients with Diabetic Kidney Disease in England: A study utilising primary and secondary care datasets
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-04-21
Organisations:
Jay Were - Chief Investigator - Health iQ
Jay Were - Corresponding Applicant - Health iQ
Archie Farrer - Collaborator - Health iQ
Dana Ogaz - Collaborator - Health iQ
Eva Maria Fuchs - Collaborator - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
Yasir Hassan - Collaborator - Health iQOutcomes:
Prevalence of DKD; Prevalence of DKD by CKD stage; Prevalence of co-morbidities and risk factors in the cohort (Genital infections, Volume depletion, Lower limb amputation, Diabetic ketoacidosis and Hypoglycaemia); Demographics (Mean and median age on inclusion, percent males, total, mean and median follow-up and geographical region); treatment pathway(prescriptions issued in primary care, number of patients needing renal replacement therapy receiving haemodialysis, peritoneal dialysis, hemodiafiltration and transplantation); Healthcare resource outcomes (procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality, Major Adverse Cardiac Event, end stage kidney disease, dialysis, transplantation, heart failure, renal complications)
Description: Technical Summary
Type 2 diabetes mellitus and chronic kidney disease frequently coexist, and each disease independently increases the risk of cardiovascular events and end-stage renal disease. Diabetes mellitus is currently the leading cause of chronic kidney disease (CKD). In fact, approximately 40% of patients with diabetes develop diabetic kidney disease (DKD) resulting in albuminuria, reduction of glomerular filtration rate (GFR), or both.
The typical natural history of diabetic nephropathy has been derived mainly from studies in patients with type 1 diabetes mellitus. In these patients, microalbuminuria is the first sign of renal damage and may eventually progress to macroalbuminuria, which predicts subsequent decline of GFR. In contrast, the natural history of CKD in type 2 diabetes mellitus appears to be heterogeneous and a result, there is still limited knowledge on the associated epidemiology, treatments pathway, clinical outcomes, co-morbidities and healthcare resource use and, costs of DKD linked with type 2 diabetes in England.
This will be a descriptive study which aims to determine which patients were diagnosed with a combination of Diabetes and subsequent CKD and determining the incidence and prevalence by CKD stage and Albuminuria category, demographic profile, co-morbidities, treatment pathway, clinical outcomes and health care resource use and costs. The study design has been chosen as this is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. CPRD-HES linked dataset has been chosen due to the availability of good quality data for prescriptions, comorbidities, procedures, demographics, costs, complications, and resource use
We shall describe the cohort in terms of patient demographic characteristics, prevalence of comorbidities, treatment pathway and clinical outcomes. Health care resource usage for the cohort will be calculated and reported for inpatient admissions, outpatient appointments, A&E attendances, and primary care appointments, tests and prescriptions. Outcomes will be described as total, means, medians, percentage or rates as appropriate.
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Extension of PAM Analysis — Imperial College Health Partners...
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Extension of PAM Analysis
Legal basis:6 Months Extension
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: PAM. Research
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Retrospective Study: Defining and Improving Access to Secondary Care for Venous Leg Ulcer Patients- A Local Perspective — Imperial College Health Partners...
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Retrospective Study: Defining and Improving Access to Secondary Care for Venous Leg Ulcer Patients- A Local Perspective
Legal basis:Retrospective Study
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Ulcer. Academic
Source -
Q Cancer Analysis — Imperial College Health Partners...
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Q Cancer Analysis
Legal basis:Extension for 6 months
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Cancer. Research
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Investigating patient pathways for Chronic Myeloid Leukaemia in North West London — Imperial College Health Partners...
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Investigating patient pathways for Chronic Myeloid Leukaemia in North West London
Legal basis:De-identified Data Access Request Extension (Previous approval):
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request Extension (Previous approval):. Commercial
Source -
Designing digitally enabled integrated care pathways, towards impactability and maximising population health. — Imperial College Healthcare NHS Trust...
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Designing digitally enabled integrated care pathways, towards impactability and maximising population health.
Legal basis:De-identified data access request
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: missing. Commmercial
Source -
Request for the extension of access to the WSIC DID for the fulfilment of the ASC model proposed over 1 year previously — Imperial College Health Partners...
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Request for the extension of access to the WSIC DID for the fulfilment of the ASC model proposed over 1 year previously
Legal basis:De-identified Data Access Extension
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Extension. Commercial
Source -
COVID19 surverllance analysis — Imperial College Healthcare NHS Trust...
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COVID19 surverllance analysis
Legal basis:Research
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Covid-19. Academic
Source -
Evaluation of healthcare service use and outcomes of people at the end of life in North – West London — Imperial College Health Partners...
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Evaluation of healthcare service use and outcomes of people at the end of life in North – West London
Legal basis:De-identified Data Access Request –
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request –. Commercial
Source
2020 - 03
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The impact of homelessness on education — unknown...
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The impact of homelessness on education
Where: unstated
When: 2020-3-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: During periods of homelessness, does disengagement from schooling increase, specifically in areas of attendance and exclusions? Does education attainment differ between homeless young people and the (housed) general population?
Addressing homelessness is a strategic priority for the Welsh Government, with the Housing (Wales) Act 2014 ushering in new duties on local authorities to take reasonable steps to assist all homeless households and to try and prevent homelessness where possible. Moreover, the First Minister has stated the intention to end youth homelessness within a decade. Though there exists some scant research in UK that demonstrates the prevalence of low or no educational qualifications and high exclusions amongst those who have experienced homelessness, there is limited evidence estimating the impacts of homelessness on schooling.
This project investigates the links between homelessness and different aspects of schooling, specifically education attainment, absenteeism, and exclusions. Findings from this project will help generate evidence on the impacts of homelessness on school, to inform efforts in Wales to end youth homelessness.
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Predicting school readiness using linked data — unknown...
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Predicting school readiness using linked data
Where: unstated
When: 2020-3-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This study aims to answer the following questions:
What are the risk factors associated with school readiness? What is the relevant weighting of importance of these risk factors in determining school readiness?"School readiness", or what is meant by children having the capacity and competency to achieve at the appropriate level in school, is strongly linked to a child's pre-school environment. School readiness encompasses language and communication skills, personal and social development, physical development, cognitive skills and basic knowledge (vocabulary). Several factors are already known to affect school readiness, including education levels of parents, income, mental health of parents, the age of the child's mother, the child's birth weight, and facilities and support available to the child.
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Healthcare and experiences of homelessness — unknown...
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Healthcare and experiences of homelessness
Where: unstated
When: 2020-3-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: Does healthcare service use, specifically attendance at A&E, increase during periods of homelessness? What are the associated costs of healthcare service use by people during periods of homelessness? And do these costs differ between different homelessness groups? Does the prevalence of substance misuse and alcohol related healthcare service interactions vary across homeless populations?
This project aims to explore the healthcare interactions of homeless people, taking the case study of a single local authority in Wales.
Worsening health, both mental and physical, can be both a cause and consequence of homelessness, with a large body of literature drawing on both survey and administrative data documenting the health of homeless people. Rather than focus on the general health of homeless populations in Wales, we will attempt to enumerate the healthcare service usage of people during periods of homelessness, to quantify the impacts of homelessness on health services and to provide an impetus for intervention across government departments, including health. Within the current knowledge base on the health of homeless people, there is a tendency to either focus on specific groups within the homeless population in isolation from others, such as rough sleepers, or to treat all homeless people as the same. The proposed study will, therefore, explore differences in healthcare needs amongst different experiences of homelessness. Specifically, our interest is in the prevalence of substance use and alcohol-related service interactions, given that drug and alcohol use can alter a personâs interactions with housing and support services, and how those services interact with the person.
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Early alcohol use in adolescence: A record linked, data-driven, predictive analytical longitudinal study — unknown...
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Early alcohol use in adolescence: A record linked, data-driven, predictive analytical longitudinal study
Where: unstated
When: 2020-3-12
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: How influential are household characteristics, childhood and adolescent mental health conditions in early alcohol use? Is a child's physical health a risk factor in early alcohol use in adolescents?
Teenage drinking is associated with long-term social and health problems. This study aims to examine the predictors of early alcohol use using Millennium Cohort Study (MCS) data and hospital data to understand if accurate predictions can be made about children who end up in hospital with an alcohol related problem.
Source -
Methodological approach to tackling homelessness —
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Methodological approach to tackling homelessness
Where: unstated
When: 2020-3-16
Opt Outs: no information provided./p>
Who: Dr Ian Thomas, Cardiff University (ADR Wales)
Datasets:see text
Why: Is there an ageing crisis in homeless services? To what extent can data from public services be used to enumerate homelessness in Wales? How could repeat homelessness be defined in Wales? How might different definitions of repeat homelessness impact estimates in Wales?
This research uses administrative data to explore the size and demographics of the homeless population in a local authority in Wales.
In their strategy for preventing and ending homelessness in Wales, Welsh Government outline that a better understanding of the scale of homelessness is a key question to address in order to better support people in housing crisis. The main source of information on homelessness comes from aggregate data on the number of households assessed and assisted by local authorities in Wales under the Housing (Wales) Act 2014. However, aggregate data only provides limited insight into homelessness; through ADR UK, for the first time, individual-level data for a single local authority has been made available, allowing for more detailed analysis and understanding of homelessness than previously possible. Of primary interest will be the presence of an ageing crisis amongst statutory housing services, and the possibility of an increasingly ageing client base. This interest in ageing and homelessness stems from evidence presented at the 4th International Conference of Administrative Data Research which demonstrated the existence of an ageing population of homeless service users in the United States. The motivation for this project, therefore, is understanding the presence of a similar 'crisis' for service provision in the UK.
Source -
Exploring the relationship between housing and wellbeing — unknown...
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Exploring the relationship between housing and wellbeing
Where: unstated
When: 2020-3-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: Is there a difference in the profile of mental and subjective wellbeing across housing tenures? And if so, do these differences persist, once taking into account peopleâs characteristics?
The Housing (Wales) Act 2014 introduced a new requirement for all private landlords in Wales to register themselves and their properties. The intention was to improve landlordism in Wales and to improve tenant experiences. However, recent debates within academia have called into question the relevance of âtenureâ, e.g. owning or renting, as a way of conceptualising housing, given that people living in tenures has diversified over time.
Given concerns about the security of Private Renter Sector (PRS) tenancies in Wales, and evidence that some households are constrained to the sector, the hypothesis is that people living in the PRS may face âworseâ mental and subjective wellbeing than those in other tenures. Findings from this project would provide a key evidence base to inform Welsh Government thinking about interventions relating to tenure in Wales, particularly whether specific tenures should continue to be sites of policy intervention.
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Can mild alcohol use during pregnancy affect children in the long-term? — unknown...
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Can mild alcohol use during pregnancy affect children in the long-term?
Where: unstated
When: 2020-3-12
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Heavy alcohol consumption by mothers during pregnancy is associated with developmental problems in their children. However, the impact of light to moderate consumption on the long-term health and educational attainment up to adolescence has not been established.This project aims to investigate the association between alcohol use of mothers during pregnancy and health and educational attainment of their children up to age 14 years.
Source -
Data First: Harnessing the potential of linked administrative data for the justice system — unknown...
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Data First: Harnessing the potential of linked administrative data for the justice system
Where: unstated
When: 2020-3-6
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Data First is an ambitious data-linking programme led by the Ministry of Justice (MoJ) and funded by ADR UK. It aims to harness the potential of the wealth of data already created by MoJ, by linking administrative datasets from across the justice system and beyond, and enabling researchers within government as well as approved academics â to access the data in an ethical and responsible way.
By working in partnership with independent and expert academics to facilitate and promote research in the justice space, we will create a sustainable body of knowledge on justice system users and their interactions with government and across the family, civil and criminal courts, to provide evidence to underpin the development of government policies and drive real progress in tackling social and justice problems.
Source -
Drug-related deaths in Northern Ireland: Socio-demographic analyses — John Hughes...
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Drug-related deaths in Northern Ireland: Socio-demographic analyses
Where: unstated
When: 2020-3-16
Opt Outs: no information provided./p>
Who: John Hughes, Northern Ireland Statistics & Research Agency (NISRA), ADR Northern Ireland.
Datasets:see text
Why: The overarching goal of the research is to advance understanding of the nature and scale of drug-related deaths in Northern Ireland. We are using the Northern Ireland Mortality Study (NIMS) â which links the 2011 Census to subsequent deaths until 2017 â to provide novel, socio-demographic insights into drug related deaths in Northern Ireland.
For drug-related deaths in Northern Ireland we are:
Examining recent trends; Assessing the socioâdemographic profile; and Modelling associations of health, socioâdemographic and local area characteristics.Northern Ireland has observed a considerable rise in drug-related deaths in the last two decades, reaching a record high of 189 deaths in 2018 according to the latest official statistics.
This is despite increased awareness of the harmful consequences of drugs. Drug misuse is an important, yet inadequately understood, public health problem in Northern Ireland, which can have tragic consequences for families and communities and creates a wider societal cost in terms of premature mortality.
Source -
The relationship between educational attainment and surviving poverty — unknown...
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The relationship between educational attainment and surviving poverty
Where: unstated
When: 2020-3-13
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Poverty affects 20% of students working on their GCSEs in Wales, thereby rendering them eligible for certain benefits, such as school meals. Of these students, 60% live with someone with at least one mental health condition. It is known that 20% of those students living with someone with a mental health condition also do well in their studies, attaining five GCSEs of A-C grade, including mathematics and English. This study aims to take a closer look at the factors associated with doing well at school for children at GCSE-level who are also living in poverty.
Source - and 36 more projects — click to show
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NHS 111 (Identifiable) (Care and Support to Individual and Secondary Uses) — Public Health England...
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The NHS Business Services Authority (acting as a data processor for Public Health England) receive NHS 111 data in order to send text messages to people who are self isolating and to check how their symptoms are progressing. — IG-00277
Recipient Data Controller Organisation(s) : Public Health England
Approval Date: 28/03/2020
Purpose for which the data is being used: The NHS Business Services Authority (acting as a data processor for Public Health England) receive NHS 111 data in order to send text messages to people who are self isolating and to check how their symptoms are progressing.
Dataset: NHS 111
Category of Data: Identifiable
Direct Care or Secondary Uses : Care and Support to Individual and Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: Consent & COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(i) â Public health DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose DPA 2018 Part 1 Schedule 1 para 3 â Public health
Statutory Authority: COPI Regulations
Common Law Duty of Confidentiality: Consent & COPI Regulations
GDPR and Data Protection Act 2018: GDPR Article 6(1)(e) â Public task GDPR Article 9(2)(g) â Substantial public interest. GDPR Article 9(2)(i) â Public health purposes. DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose. DPA 2018 Part 1 Schedule 1 para 3 â Public health.
National Data Opt-out Applied: Not Applied â Consent.
Source -
Shielded Patient List (SPL) (Identifiable) (Care and Support to Individual) — NHS Clinical Commissioning Groups (CCGs)...
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The Shielded Patient List (SPL) is used by each CCG to coordinate the clinical response to COVID-19 on the vulnerable patients within its respective local area. For the purposes of providing GP practices with support, and patients in their CCG area with support and care — IG-00375
Recipient Data Controller Organisation(s) : NHS Clinical Commissioning Groups (CCGs)
Approval Date: 28/03/2020
Purpose for which the data is being used: The Shielded Patient List (SPL) is used by each CCG to coordinate the clinical response to COVID-19 on the vulnerable patients within its respective local area. For the purposes of providing GP practices with support, and patients in their CCG area with support and care
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Care and Support to Individual
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: General COPI Notice
Common Law Duty of Confidentiality: General COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest GDPR Article 9(2)(g) â Reasons of substantial public interest
National Data Opt-out Applied: Not Applied â Legal Obligation overrides & public interest.
Source -
Shielded Patient List (SPL) (Identifiable) (Direct Care) — NHS England...
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For Capita as a Processer for NHSE to send letters to patients on the Shielded Patient List (SPL) to provide them with advice on shielding. — IG-00343
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 20/03/2020
Purpose for which the data is being used: For Capita as a Processer for NHSE to send letters to patients on the Shielded Patient List (SPL) to provide them with advice on shielding.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Direct Care.
Source -
Shielded Patient List (SPL) (Identifiable) (Care and Support to Individual and Secondary Uses) — Cabinet Office...
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To provide individuals on the Shielded Patient List (SPL) with a way to seek help and support whilst they are self-isolating to protect themselves from the COVID-19 virus, including by providing a means to ask for social care support and essential food and supplies. Also certain secondary uses, including surveys. — IG-00307
Recipient Data Controller Organisation(s) : Cabinet Office
Approval Date: 22/03/2020
Purpose for which the data is being used: To provide individuals on the Shielded Patient List (SPL) with a way to seek help and support whilst they are self-isolating to protect themselves from the COVID-19 virus, including by providing a means to ask for social care support and essential food and supplies. Also certain secondary uses, including surveys.
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Care and Support to Individual and Secondary Uses
Statutory Authority: Health and Social Care Act 2012 section 261(5)(c)
Common Law Duty of Confidentiality: Public Interest
GDPR and Data Protection Act 2018: GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: Governmental Functions
Common Law Duty of Confidentiality: Public Interest
GDPR and Data Protection Act 2018: GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Overriding Public Interest.
Source -
Shielded Patient List (SPL) (Identifiable) (Direct Care ) — NHS England...
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To identify individuals within the prison population TPP patient record system who are on the Shielded Patient List and more vulnerable/high risk in relation to COVID-19 — IG-00334
Recipient Data Controller Organisation(s) : NHS England
Approval Date: 30/03/2020
Purpose for which the data is being used: To identify individuals within the prison population TPP patient record system who are on the Shielded Patient List and more vulnerable/high risk in relation to COVID-19
Dataset: Shielded Patient List (SPL)
Category of Data: Identifiable
Direct Care or Secondary Uses : Direct Care
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice & Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice & Implied Consent
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 6(1)(d) â Vital interests GDPR Article 6(1)(e) - Public task GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Direct Care.
Source -
Shielded Patient List (SPL) (Pseudonymised ) (Secondary Uses) — NHS England...
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To analyse the data, including linking it with other pseudonymised data for the purposes of producing COVID-19 dashboards available to authorised users through the COVID-19 Data Store. — IG-00497
Recipient Data Controller Organisation(s) : NHS England NHS Improvement
Approval Date: 28/03/2020
Purpose for which the data is being used: To analyse the data, including linking it with other pseudonymised data for the purposes of producing COVID-19 dashboards available to authorised users through the COVID-19 Data Store.
Dataset: Shielded Patient List (SPL)
Category of Data: Pseudonymised
Direct Care or Secondary Uses : Secondary Uses
Statutory Authority: NHSD COPI Notice
Common Law Duty of Confidentiality: NHSD COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
Statutory Authority: NHSE COPI Notice
Common Law Duty of Confidentiality: NHSE COPI Notice
GDPR and Data Protection Act 2018: GDPR Article 6(1)(c) â Legal obligation GDPR Article 9(2)(g) â Reasons of substantial public interest DPA 2018 Part 2 Schedule 1 para 6 â Statutory and governmental purpose
National Data Opt-out Applied: Not Applied â Legal obligation overrides & pseudonymised data.
Source -
Developing a predictive Tool using data linkage and machine learning, to promote Earlier Diagnosis of Type 1 diabetes in childhood for use in primary care  the TED study — Julia Townson ...
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Developing a predictive Tool using data linkage and machine learning, to promote Earlier Diagnosis of Type 1 diabetes in childhood for use in primary care  the TED study
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-24
Organisations:
Julia Townson - Chief Investigator - Cardiff University
Julia Townson - Corresponding Applicant - Cardiff University
Ambika Shetty - Collaborator - Cardiff and Vale University Health Board
Hywel M. Jones - Collaborator - Cardiff University
John Gregory - Collaborator - Cardiff University
Nick Francis - Collaborator - University of Southampton
Rhian Daniel - Collaborator - Cardiff University
Shantini Paranjothy - Collaborator - University of AberdeenOutcomes:
This application relates to testing the utility of a predictive tool, to be used in primary care, to detect children who have developed T1D. The outcome measures listed relate to this part of the study and this application.
Overall our outcomes to be measured are:-
1. The number of earlier diagnoses our algorithm might be able to achieve
2. The average number of days by which the diagnosis might have been anticipated in these cases
3. The number of DKA cases in which an earlier diagnosis might be facilitated
4. The number of finger prick tests that would have been performed (including the false positive ones)Description: Technical Summary
The training phase will use SAIL-BRECON data, which includes information on childrenÂs primary care consultations and those with T1D during the study period (01/01/2000  31/12/2016). At each unique date at which a patient interaction with primary care occurs, information on a collection of flags pertaining to that interaction will be extracted, along with gender, age, and the date a T1D diagnosis occurred, or the patient was censored (whichever is earlier), together with the accompanying event indicator. We will use machine learning algorithms (using SuperLearner in R) to predict time to T1D diagnosis from the information available at the Âcurrent primary care interaction, also taking the number, timing and information from past interactions into account. We will use V-fold cross-validation to find an optimal balance between under- and over-fitting, ultimately selecting the Âbest linear combination of all algorithms based on the V-fold cross-validated estimate of the area under the Receiver Operating Characteristic (ROC) curve.
Once the algorithm is developed using SAIL-BRECON data it will be adapted, tested and validated using CPRD-HES data. Hospital Episode Statistics (HES) data will be used to detect when a child was diagnosed with T1D and whether they presented in DKA. The CPRD-HES linked data will provide all primary care interactions with children between 01/01/2000 Â 31/12/2016; aged 0-14; date of T1D diagnosis; and DKA status. We will apply our trained diagnosis algorithm with a suitable range of thresholds for prompting blood glucose (BG) testing, to mimic outcomes had our algorithm been in operation. Using a number of assumptions (the sensitivity to which we will assess), will allow us to estimate the proportion of diagnoses that could be anticipated; average number of days that diagnosis could be anticipated; number of DKAs that would be avoided; and the number of BG tests (including negative ones) performed to achieve this.
Source -
Clustering of multi-morbidity in stroke survivors — Efthalia (Lina) Massou ...
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Clustering of multi-morbidity in stroke survivors
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-30
Organisations:
Efthalia (Lina) Massou - Chief Investigator - University of Cambridge
Efthalia (Lina) Massou - Corresponding Applicant - University of Cambridge
Duncan Edwards - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of Cambridge
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK Headquarters
Yajing Zhu - Collaborator - University of Cambridge
Zhirong Yang - Collaborator - University of CambridgeOutcomes:
Multimorbidity defined as having two or more of 36 long-term conditions recorded in patients' medical records (1); number of primary care consultations; number of prescriptions a patient has been issued; number of hospital admissions; mortality.
Description: Technical Summary
Multimorbidity accounts for 25% of the adult UK population, and over half of hospital admissions and GP appointments. The Academy of Medical Sciences, the NHS in the Long-Term Plan and other organisations have reported multimorbidity as a priority for global health research and call for investigation into patterns of multimorbidity, and for greater understanding of the burden and determinants of common clusters of conditions. Multimorbidity is particularly prevalent in stroke/transient ischaemic attack (TIA; often referred to as Âmini-strokeÂ) survivors (~94%). However, despite the high prevalence of multimorbidity in stroke/TIA patients, no studies have investigated how multimorbidity is structured within the stroke/TIA survivor population.
Using the Clinical Practice Research Datalink (CPRD) GOLD database, which provides clinical primary care data from UK general practices, this research aims:
1. To classify common clusters of multimorbidity within the stroke/TIA survivor population.
2. To describe how health outcomes differ among different stroke-multimorbidity clusters.
3. To describe how determinants of health differ among different stroke/ TIA-multimorbidity clusters.In a cross-sectional approach, we will focus on adults surviving a stroke/ TIA. Utilizing a 3-year follow up period we will estimate death, primary care consultation and hospital admission rates. We will link the CPRD GOLD data with area socioeconomic deprivation data and Hospital Episodes Statistics. Multimorbidity is defined as having two or more of 36 long-term conditions. A model-based person-centred cluster analysis, the latent class analysis (LCA) calculating the class membership probabilities among patients will be used. The number of clusters will be defined through statistical criteria (Bayesian Information Criteria (BIC), sample-sized adjusted BIC, log-likelihood ratio test, entropy for classification quality) and clinical input. We will describe the clusters in terms of comorbidities and identify key characteristics and health outcomes (mortality, hospital admission, primary care appointments) associated with them.
We will identify the highest need and commonest clusters so that these can be prioritised in service development.
Source -
Risk factors for pertussis in older adults aged 50 years and above, and the incidence and economic burden of pertussis overall and in high-risk groups using the merged CPRD GOLD and Aurum database, and Hospital Episode Statistics (HES) — Emmanuel ARIS ...
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Risk factors for pertussis in older adults aged 50 years and above, and the incidence and economic burden of pertussis overall and in high-risk groups using the merged CPRD GOLD and Aurum database, and Hospital Episode Statistics (HES)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-04
Organisations:
Emmanuel ARIS - Chief Investigator - GSK
Nicola Sawalhi-Leckenby - Corresponding Applicant - Evidera, Inc
Amit Bhavsar - Collaborator - GSK
Anna Ramond - Collaborator - Evidera, Inc
Chris Colby - Collaborator - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Elisa Turriani - Collaborator - GSK
Esse Ifebi Herve Akpo - Collaborator - GSK
Evie Merinopoulou - Collaborator - Evidera, Inc
Germain Lonnet - Collaborator - GSK
Jason Simeone - Collaborator - Evidera, Inc
Kinga Meszaros - Collaborator - GSK
Lauriane Harrington - Collaborator - GSK
Nathalie Servotte - Collaborator - GSK
Noami Berfeld - Collaborator - Evidera, Inc
Piyali Mukherjee - Collaborator - GSK
Robert Donaldson - Collaborator - Evidera, Inc
Sharon MacLachlan - Collaborator - Evidera, Inc
Yves BRABANT - Collaborator - GlaxoSmithKline Biologicals SA, BelgiumOutcomes:
1.     Diagnosis of pertussis based on relevant Read codes, SNOMED codes and ICD-10 codes (Appendix 1).
2. Medical resource utilization (MRU) associated with occurrence of pertussis, assessed via number and proportion with at least one use of resources, and number of resources per patient per year, including:
a. GP consultations/nurse visits
b. Prescribed medications
c. Laboratory tests
d. Outpatient specialist visits
e. Accident and Emergency (A&E) visits
f. Hospital inpatient admissions (all-cause)3. Total cost per patient per year (Pound Sterling) associated with occurrence of pertussis, assessed as the sum of costs associated with:
a. GP consultations/nurse visits
b. Prescribed medications
c. Laboratory tests
d. Outpatient specialist visits
e. A&E visits
f. Hospital inpatient admissions (all-cause)Description: Technical Summary
Pertussis (whooping cough), a highly contagious disease caused by Bordetella pertussis, affects the respiratory system (McGuinness et al., 2013). Among older adults (those ?50 years) and particularly those with comorbidities such as chronic obstructive pulmonary disease (COPD) or asthma, there is scarce information on the incidence of pertussis, or its associated clinical and economic burden. Prior evidence suggests that potential complications among these populations could lead to hospitalisation (Buck et al., 2017; Capili et al., 2012; Pesek & Lockey, 2011). Overall, the clinical and economic burden of pertussis in older adults in the UK is considerably underestimated and not well-characterised (Caro et al.,2005; Masseria & Krishnarajah, 2015).
This primarily descriptive study plans to identify risk factors for pertussis among older adults (?50 years), and to estimate the incidence of pertussis overall in the general UK population of older adults, as well as among additional cohorts identified as being at high risk of pertussis (those with comorbid COPD, asthma, or heart failure), over a 10-year period from 2009 to 2018. Incidence rates will be stratified by age groups and by calendar year. A matched case-control study design will be used to assess risk factors for pertussis and the associated economic burden. Resource use in the primary and secondary care setting, estimated as the rate of events per patient per year accounting for differential follow-up, and associated costs per patient per year will be estimated for older adults with pertussis versus controls without pertussis. The analyses will be conducted among the overall cohort of older adults and the known high-risk cohorts (COPD, asthma, and heart failure), as well as any other newly identified high-risk cohorts.
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Cardiovascular risk factors and longer-term outcomes in individuals with Down syndrome — Andre Strydom ...
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Cardiovascular risk factors and longer-term outcomes in individuals with Down syndrome
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-27
Organisations:
Andre Strydom - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Aisha Aslam - Collaborator - London Northwest University Hospitals NHS Trust
Asaad Baksh - Collaborator - King's College London (KCL)
Li Chan - Collaborator - Queen Mary University of London
Sarah Pape - Collaborator - King's College London (KCL)Outcomes:
ischaemic heart disease (IHD) including myocardial infarcts, dementia (any type), stroke, late onset epilepsy/ seizures,
Description: Technical Summary
The study of comorbidity patterns in DS will help us understand the development of conditions associated with trisomy 21 during the lifespan. Our overarching hypothesis is that cardiovascular (CV) risk factor patterns in DS individuals will vary by age and sex, and show commonalities and differences in comparison with general population controls that is not solely explained by co-occurrence of intellectual disability, and that these will relate to longer term outcomes such as the development of dementia in addition to the genetic risk for AlzheimerÂs disease in DS due to APP-gene triplication.
Objectives:
We will include individuals with Down syndrome in the CPRD datasets (GOLD, and Aurum) and 1) define their unique cardiovascular risk profiles, 2) define longitudinal trajectories of cardiovascular risk factors (particularly blood pressure and obesity) and 3) explore the longitudinal relationship between these risk factors and the development of associated complications (dementia, stroke, seizures) in DS.
Methods:
We will select a cohort of individuals with DS from CPRD and conduct cross-sectional and longitudinal analyses in comparison with two sex, age and general practice matched control groups: individuals from the general population, and those who have intellectual disabilities but not Down syndrome:
1. to explore the relationships between cardiovascular risk factors (obesity, blood pressure, diabetes, cholesterol and smoking) and other common comorbidities typically associated with DS, as well as socio-economic profiles (using the Index of multiple deprivation),
2. to explore the evolution of hypertension, body mass index values and obesity
3. to predict longitudinal outcomes (e.g. ischaemic heart disease, dementia, stroke, late onset seizures) in adults with DS aged 35 and older.
4. As exploratory analysis, we will consider whether obese individuals with DS (BMI of 35kg/m2 or more; or equivalent BMI in children) are more or less likely than matched general population controls to successfully lose weight in response to interventions commonly offered in primary care (such as referral to dieticians and prescriptions for exercise)
Source -
Characterisation, prediction of complications, and safety of emergent therapies for viral outbreaks and pneumonia: a rapid network study to inform management of COVID-19 — Patrick Ryan ...
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Characterisation, prediction of complications, and safety of emergent therapies for viral outbreaks and pneumonia: a rapid network study to inform management of COVID-19
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-23
Organisations:
Patrick Ryan - Chief Investigator - Janssen Research & Development LLC
Patrick Ryan - Corresponding Applicant - Janssen Research & Development LLC
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University Hospitals
Martijn Schuemie - Collaborator - Janssen US
Sara Khalid - Collaborator - University of OxfordOutcomes:
 Viral infection Pneumonia
 Adult distress respiratory syndrome
 Advanced life support including ICU and/or mechanical ventilation or intubation
 All-cause death
 Known adverse effects for the studied medicinesDescription: Technical Summary
Data from previous viral outbreaks including the seasonal flu can be used to generate evidence that may help to inform the response to the current Coronavirus COVID-19 pandemic. One dataset that could provide many useful insights is the Clinical Practice Research Datalink (CPRD GOLD and AURUM) linked to Hospital Episode Statistics admitted patient care data (HES-APC).
Using such data, we aim to answer the following three research questions:
1) What are the features and characteristics of the symptoms and complications of seasonal flu and Covid19 infections, with a particular focus on pneumoniae?
2) What are the predictors of adverse outcomes amongst patients with flu- or Covid19-related hospitalization? And can we, by combining them, generate algorithms that can help us identify subjects most at risk of complications and/or morbi-mortality?
AND 3) What are the effects of treatments being considered/used for potential use in COVID-19, including hydroxychloroquine, antivirals, systemic steroids, and angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB)?CPRD GOLD, AURUM, and linked HES-APC will be mapped to Observational Medical Outcomes Partnership (OMOP) common data model (CDM). Performing the analysis on mapped data will allow for the study to be replicated in other data sources that have also been mapped to the OMOP CDM, including Asian data with COVID-19 cases already available from South Korea.
We will update the extracted data in the coming months with new cohorts of patients and their electronic medical records during the current calendar year to include those with COVID-19 so that once mapped to the OMOP CDM, findings can be further validated. COVID19 UK cohorts are expected to be available from CPRD GOLD, AURUM and linked HES from Q3 or Q4 2020.
Source -
The Epidemiology of Progressive Supranuclear Palsy in the United Kingdom — Emma Viscidi ...
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The Epidemiology of Progressive Supranuclear Palsy in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-27
Organisations:
Emma Viscidi - Chief Investigator - Biogen
Li Li - Corresponding Applicant - Biogen
Adrian Harrington - Collaborator - Biogen
Huw Morris - Collaborator - National Hospital for Neurology and Neurosurgery
Susan Eaton - Collaborator - Biogen
Yoshihiko Inuzuka - Collaborator - BiogenOutcomes:
Prevalence of PSP; Incidence rate of PSP; Prevalence of comorbidities; Prevalence of medications; Prevalence of hospitalized procedures; All-cause hospitalisation; All-cause mortality; Cause of death; Disease duration.
Description: Technical Summary
The study objectives are to estimate the diagnosed prevalence and incidence of Progressive Supranuclear Palsy (PSP) in the United Kingdom (UK) and to describe PSP patient characteristics, including comorbidities, hospitalizations, and medication utilization. PSP cases and age and sex-matched controls will be identified from 1987-2018 in the CPRD GOLD database. PSP will be defined as one or more Read code for PSP (as listed in Appendix A) and index date (date of first PSP code) age 40 years or older. Prevalence and incidence of PSP will be calculated and age-adjusted to the UK Census Population. The frequency of comorbidities (including PD), medications, and hospitalisations will be examined in PSP cases and controls. Hospital Episode Statistics (HES) data will be used to determine hospitalisations. Mortality data will be obtained from CPRD GOLD and linked ONS data.
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The risk of cancer among opioid users: a nested case-control study — Samy Suissa ...
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The risk of cancer among opioid users: a nested case-control study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-04
Organisations:
Samy Suissa - Chief Investigator - McGill University
Ana Velly - Corresponding Applicant - McGill University
Daniel Morales - Collaborator - University of Dundee
Dwight Moulin - Collaborator - University Of Western Ontario
Eduardo Franco - Collaborator - McGill University
Igor Karp - Collaborator - University Of Western Ontario
Larus Gudmundsson - Collaborator - University of Iceland
Mervyn Gornitsky - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Russell Steele - Collaborator - McGill UniversityOutcomes:
The primary outcome is the first diagnosis of cancer at one of the following sites: colon/rectum, breast, prostate, kidney, or brain. The secondary outcomes are the specific cancer diagnosis: colon/rectum, breast, prostate, kidney or brain cancers.
Description: Technical Summary
Rationale. A preference for the use of opioid analgesics has increased substantially in recent years. Opioids are associated with the risk of pneumonia, which could be due to suppression of immune function and studies have also suggested a possible role of opioids use in carcinogenesis.
Objective. The objectives are to determine whether opioid use is associated with the increased risk of cancer, when compared to non-use; and to determine whether there is a dose- and duration-response relationship between opioids and the increased risk of cancer.
Method. We will perform a nested case-control analysis of data from the Clinical Practice Research Datalink (CPRD). The source population will consist of adults registered with CPRD practices, between 1 January 2000 and 31 December 2019. We will identify incident cases of colorectal, breast, prostate, kidney and brain cancers identified by diagnosis codes from READ of the CPRD. The index date will be the date of cancer diagnosis. Up to 10 controls will be randomly selected from each case's risk set, after matching on year of birth, cohort entry, index date, sex, and general practice. All controls will be alive and free of cancer at the index date. ÂEver exposed to opioids will be defined as receiving at least one opioid prescription between cohort entry and 5 years preceding the index date. Conditional logistic regression analysis will be used to estimate the adjusted rate ratios of cancer as a function of use of opioid analgesics compared to non-use, and opioids dose and duration.
Significance. This study will provide useful clinical information on whether opioids are associated with the risk of cancer.
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An observational study of early versus late tapentadol initiation for the treatment of chronic pain: comparison of adverse events and resource use with morphine or oxycodone — Christopher Morgan ...
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An observational study of early versus late tapentadol initiation for the treatment of chronic pain: comparison of adverse events and resource use with morphine or oxycodone
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-24
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Garth Baxter - Collaborator - Grünenthal Ltd. UK
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Baseline characteristics; pain aetiology; pain site; adverse events, opioid related disorders, opioid related deaths; primary care contacts, outpatient contacts, accident and emergency contacts, inpatient contacts.
Description: Technical Summary
The study aims to determine if there is an association between gastrointestinal outcomes and early treatment with tapentadol compared to treatment with morphine or oxycodone. Patients will be selected from CPRD AURUM with a prescription for tapentadol SR recorded between May 2011 and April 2019. A prior pain pathway will be estimated by combining over-lapping prescriptions of non-opioids, co-analgesics, weak opioids and strong opioids for pain management. First prescription of tapentadol SR will define index date. Patients prescribed tapentadol as the first therapy within the strong opioid category during their pain episode will be defined as Âearly Âinitiators, those prescribed tapentadol subsequent to an alternate strong opioid will be defined as Âlate initiators. Both cohorts of tapentadol patients will be matched to two sets of controls at a ratio of 1:2, the first treated with morphine and the second treated with oxycodone. The primary outcome will be time to adverse gastrointestinal event, secondary outcomes will be time to either constipation or nausea, primary and secondary care resource use and associated costs. Rates of progression to the primary outcome will be presented and compared using Cox proportional hazard models (CPHM) adjusting for smoking status, Charlson Index, total number of contacts with the general practitioner in the year prior to the index date, and quintile of the Index of Multiple Deprivation. Rates of resource use and associated costs will be compared using regression models based on the Poisson and Gamma distributions respectively.
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Analysing the effect of lithium cessation on renal function in patients with bipolar disorder — Rudolf Cardinal ...
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Analysing the effect of lithium cessation on renal function in patients with bipolar disorder
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-13
Organisations:
Rudolf Cardinal - Chief Investigator - University of Cambridge
Rudolf Cardinal - Corresponding Applicant - University of Cambridge
Efthalia (Lina) Massou - Collaborator - University of Cambridge
Shanquan Chen - Collaborator - University of Cambridge
Soumya Banerjee - Collaborator - University of Cambridge
Thomas Hiemstra - Collaborator - University of CambridgeOutcomes:
Rate of change in eGFR over time for patients and control.
Description: Technical Summary
Bipolar affective disorder (bipolar disorder, BD) is a severe psychiatric disorder affecting 1-3% of the general population. Management is life-long as onset typically occurs early in life. Lithium is an effective treatment, but is associated with kidney damage. Approximately 30% of patients taking lithium long-term will be diagnosed with early stage chronic kidney disease (CKD); 2-5% of patients will require dialysis, and 0.5% will experience end-stage renal disease (ESRD) (Mcknight et al., 2012). Nephrologists currently advise patients to discontinue lithium when CKD stage 3 is reached (estimated glomerular filtration rate eGFR < 60 mL/min/1.73m2).
Lithium withdrawal studies are few and conflicting as to the extent and reversibility of glomerular kidney damage. Some data suggest that once CKD is established, eGFR further declines irrespective of lithium withdrawal (Bocchetta et al., 2015; Bendz et al., 2010).
Case studies (Hajek, Alda, & Grof, 2011; Dehning et al., 2017) suggest withdrawal from lithium can result in unmanaged BD and loss of life from suicide. Switching to another mood stabiliser late in the disease course may not be an effective solution, since drug side effects and renal damage may persist or worsen (Werneke et al., 2012).
There is a need for further longitudinal studies to review renal function where patients have withdrawn from lithium treatment. Clinicians and patients require clear information to assess the risks and benefits of continued lithium treatment where renal impairment or failure is present.
Analytical plan. We will predict eGFR via classical and Bayesian statistical techniques, estimating the instantaneous effect of taking lithium on eGFR, the change in eGFR velocity attributable to being on lithium, and the effect on eGFR trajectory of lithium cessation (past but not current lithium use).
Impact. Our analyses will contribute to improving patient-centred care and decision making for patients with BD on life-long treatment.
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Epidemiology of non-fatal self-harm, suicide and other causes of premature death following discharge from inpatient psychiatric care — Roger Webb ...
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Epidemiology of non-fatal self-harm, suicide and other causes of premature death following discharge from inpatient psychiatric care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-25
Organisations:
Roger Webb - Chief Investigator - University of Manchester
Rebecca Musgrove - Corresponding Applicant - University of Manchester
- Collaborator -
Carolyn Chew-Graham - Collaborator - Keele University
Darren Ashcroft - Collaborator - University of Manchester
Luke Munford - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Thomas Allen - Collaborator - University of ManchesterOutcomes:
Phase 1: All-cause mortality; all natural deaths; all unnatural (external cause) deaths; suicide; accidental death;
alcohol-specific death; drug-related death; non-fatal self-harm; readmission to psychiatric inpatient care
Phase 2: Rates and costs of primary care contacts and psychotropic medication use; A&E admission; admission to a psychiatric inpatient unit; admission to a general inpatient unit; outpatient visits.
Phase 3: SuicideDescription: Technical Summary
Phase 1 is a matched cohort study aiming to estimate the absolute and relative risk of suicide, other causes of mortality, non-fatal self-harm and first psychiatric readmission, for people in the first year after discharge from inpatient psychiatric care in England. Cumulative incidence will be calculated for each examined outcome for people discharged for the first time between 1st January 2001 and 31st May 2018, and for a general population comparison cohort matched on age, gender and registered general practice. Hazard ratios comparing risks between the two groups will be calculated using Cox proportional hazards models at different time points within the first year. Where statistical power is sufficient estimates will be stratified by gender and age group (10-17, 18-64 and over 64). Phase 2 will describe general practice management (prescription of psychotropic medication and timing of first contact) and calculate rates of GP contact and hospital use (A&E attendance, admission to a general hospital, psychiatric ward or outpatient appointment) during the year after discharge from psychiatric inpatient care. Adjusted rate-ratios comparing rates of contact versus the general population will be calculated using Poisson regression. Reference costs for each component of care will be used to calculate the excess cost of care per discharged person. Phase 3 will consider how those who die by suicide within a year of discharge vary in their primary care and hospital use compared to living controls in the same cohort. Using a nested case-control design all discharged persons who die by suicide will be matched with controls by gender, age-group and year of discharge. Conditional multiple logistic regression models will be fitted to detect any associations between primary care and hospital use and likelihood of suicide occurring within a year.
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Risk of death in childhood epilepsy — Richard Chin ...
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Risk of death in childhood epilepsy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-11
Organisations:
Richard Chin - Chief Investigator - University of Edinburgh
Richard Chin - Corresponding Applicant - University of Edinburgh
Christian Schnier - Collaborator - University of EdinburghOutcomes:
The main outcome is all-cause mortality hazard in CWE, up to a maximum age of death of 20 years. Cause of death will be subclassified into epilepsy-related, natural not epilepsy-related, unnatural not epilepsy related, and unknown.
Description: Technical Summary
Mortality rate and causes of death in children (aged less than 19 years) with epilepsy (CWE) in the UK is uncertain. Such information can help guide policy and resource allocation for CWE to reduce their risk of premature death.
We propose to carry out a prospective, cohort study using the latest electronic primary care data set linked to hospitalization, mortality, and deprivations records available through the Clinical Practice Research Datalink (CPRD). We will determine an epilepsy (exposed) and comparison group (unexposed) from a subset of general practitioner practices whose anonymized patient-level data are linked to the Office for National Statistics (ONS) mortality records, Index of Multiple Deprivation 2010, and Hospital Episode Statistics (HES). These sources will provide information on date and cause of death (ONS), quintiles of deprivation based on patient postcodes (Index of Multiple Deprivation 2010), and inpatient hospitalizations (HES).
All children born between January 1, 1998 and January 14, 2018 will be included to ensure a follow-up period of at least one year. We will follow-up children up to a maximum of age 20 years. We will define epilepsy index date as the latest date at which someone received both an epilepsy diagnostic code and an associated AED prescription based on read diagnosis codes and prescription codes used in a previous validation study.
Cause of death will be that provided from ONS data, and subclassified into epilepsy-related death, natural non-epilepsy related, unnatural death and unknown. Risk of mortality (primary outcome) will be analysed using parametric and non-parametric survival analysis, adjusting for effects of sex, year of birth and deprivation. We will calculate mortality rate by dividing the number of events by the sum of person-years at risk. We will estimate standardised mortality ratio by comparing the mortality rate of CWE compared to controls.
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A retrospective database study characterising clinical pathways and healthcare resource utilisation among patients with iron deficiency (ID) or iron deficiency anaemia (IDA) in England — Phil McEwan ...
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A retrospective database study characterising clinical pathways and healthcare resource utilisation among patients with iron deficiency (ID) or iron deficiency anaemia (IDA) in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-25
Organisations:
Phil McEwan - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Oksana Kirichek - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
- Collaborator -
Daniel Murphy - Collaborator - Norgine
Matthew Turner - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Nia Jenkins - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
William Burch - Collaborator - NorgineOutcomes:
Clinical and economic outcomes will be measured in this study. These outcomes are further described in section N., and will include the following:
Clinical outcomes
 Time from ID or IDA diagnosis to first iron therapy, where index event is diagnosis not prescription
 Number of lines of iron therapy
 Number of IV iron infusions or injections
 Number of intramuscular iron injections
 Length of time on oral iron therapy
 Change in Hb concentration, and other haematological and biochemical markers, over time
 Duration of Hb normalisation* while on treatment
 Duration of Hb normalisation* not on treatment
 Treatment change
 Treatment adherence
 Treatment-related side effects
 Treatments related to iron therapy or anaemia*Normalisation defined as Hb?12 g/dL in (non-pregnant) female patients and ?13 g/dL in male patients(1), but other definitions may apply to patient subgroups of interest in this study
Economic (healthcare resource) outcomes
 Iron therapy prescribing
 Primary care attendances
 Referrals to secondary care clinic
 Outpatient appointments
 Accident and Emergency department attendances
 Hospital admissions
 Length of hospital stay
 Blood tests and other investigationsOther outcomes
 Reason for lost to follow up, where recordedDescription: Technical Summary
Patients with iron deficiency (ID) or iron deficiency anaemia (IDA) require iron therapy to normalise haemoglobin (Hb) levels and replenish body iron stores. These conditions often occur alongside, and due to, comorbid conditions, including inflammatory bowel disease (IBD), chronic kidney disease (CKD) and cancer. Little is known about the nature and extent of ID and IDA management in England.
This retrospective cohort study will investigate the profiles of ID/IDA patients, their iron therapy treatments and outcomes in England. The study will describe treatment pathways for ID and IDA in primary care and secondary care, patients demographic and clinical characteristics, their haematological and biochemical treatment outcomes and the economic (healthcare resource) impact of treatment.
Primary care data will be extracted from Clinical Practice Research Datalink (CPRD) for patients aged ?18 years on the date of first ever recorded diagnosis of ID or IDA or date of first ever iron therapy prescription (index event between 01 July 2007 and 30 June 2018). The study period will be from 01 July 2007 to 30 June 2019, with a lookback period of up to five years from the index date to measure comorbidities and clinical history.
Patient characteristics will be measured at baseline. Clinical pathways will be described using CPRD data linked to inpatient, outpatient and Accident & Emergency Hospital Episode Statistics (HES) data. Patterns in iron treatment prescribing will be analysed. The economic (healthcare resource utilisation) impact of ID and IDA management, such as hospitalisations, and associated costs will be quantified .
Descriptive analyses using chi-square tests and t-tests and multivariable analyses using logistic or linear regression, and Kaplan-Meier, where appropriate, will be undertaken. Sensitivity analyses will investigate temporal patterns in iron treatment prescribing and the impact of fluctuating patient numbers over the study period. Exploratory analyses, if data quality allows, will investigate outcomes related to haematological and biochemical markers.
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Cardiovascular disease in type 2 diabetes: characterisation of treatment variation in the UK CPRD — Ruth Farmer ...
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Cardiovascular disease in type 2 diabetes: characterisation of treatment variation in the UK CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-27
Organisations:
Ruth Farmer - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Ruth Farmer - Corresponding Applicant - Boehringer-Ingelheim Pharmaceuticals, Inc
Andrew McGovern - Collaborator - University of Exeter
Andrew Ternouth - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Ivan Beard - Collaborator - Boehringer-Ingelheim - UK
Naresh Kanumilli - Collaborator - NHS England
Nicholas Gollop - Collaborator - Boehringer-Ingelheim - UK
Niraj Patel - Collaborator - Boehringer-Ingelheim - UK
Syed Raza - Collaborator - Boehringer-Ingelheim - UKOutcomes:
Current prescription for a:
Biguanide
Sulfonylureas (SU)
Dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor)
Thiazolidinedione (TZD)
Sodium-glucose co-transporter-2 (SGLT2 inhibitor)
Glucagon-like peptide 1-receptor agonists (GLP1-RA)
Insulin
Any other glucose lowering medication (Nateglinide, Repaglinide, Acarbose)New prescription of an:
SGLT2 inhibitor
GLP1-RA
DPP-4 inhibitor
Sulfonylurea s
Insulin
Other (TZD, Biguanide, Nateglinide, Repaglinide, Acarbose)Description: Technical Summary
Recent studies suggest that selected diabetes treatments (namely sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide 1-receptor agonists (GLP1-RAs)) have significant cardio-protective benefits. A recent estimate of the UK prevalence of cardiovascular disease (CVD) within type 2 diabetes (T2DM) is 35%; but the treatment patterns of these patients remains unclear. In particular, the extent to and stage at which SLGT2 inhibitors and GLP1-RAs are used across the UK, and how usage differs from those without CVD is unknown. With a shift to looking beyond glycaemic control to manage diabetes and its complications, it is important to understand the current treatment patterns of these patients; what clinical and demographic characteristics may be associated with class choice at point of intensification; and how this compares to recent ADA/EASD recommendations. This study therefore aims to:
- Describe prescribing variation by class in patients with T2DM by history of CVD; by UK geographical region; and by calendar year since 2017.
- Describe and compare characteristics of those initiating different classes of medication within the past 3 years by CVD history and intensification stage.The study will use primary care data to establish a cohort of patients with T2DM, from which we will use cross sectional sub-populations to estimate prevalence of class use through time. From the same underlying cohort, a sub-cohort of initiators will be used for comparisons of patient characteristics.
The main outcomes (prescription for/ initiation of a particular class of T2DM medication) will be ascertained using prescription data. The main exposure (CVD history) will be ascertained using clinical diagnoses in the primary care record. Prevalence by time, CVD history and treatment stage will be presented descriptively, with exact 95% confidence intervals for proportions to quantify uncertainty. The association between patient characteristics and choice of class initiated will be estimated using multinomial regression models.
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An Evaluation of Risk Factors, Treatment Patterns and Outcomes Among Patients Treated with Lipid Lowering Therapy in the United Kingdom from 2008 to 2017 — Mark Danese ...
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An Evaluation of Risk Factors, Treatment Patterns and Outcomes Among Patients Treated with Lipid Lowering Therapy in the United Kingdom from 2008 to 2017
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-27
Organisations:
Mark Danese - Chief Investigator - Outcomes Insights ( Outins )
Mark Danese - Corresponding Applicant - Outcomes Insights ( Outins )
David Catterick - Collaborator - Amgen Ltd
Deborah Lubeck - Collaborator - Outcomes Insights ( Outins )
Eduard Sidelnikov - Collaborator - Amgen Ltd
Guillermo Villa - Collaborator - Amgen Ltd
Jeetesh Patel - Collaborator - NHS England
Mazhar Iqbal - Collaborator - Amgen Ltd
Michelle Gleeson - Collaborator - Outcomes Insights ( Outins )
Youssef Beaini - Collaborator - NHS EnglandOutcomes:
Myocardial infarction [MI]; ischemic stroke [IS]; revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG])
Description: Technical Summary
This is a descriptive study whose primary objective is to describe changes over time in cardiovascular disease risk factors, treatment patterns, and cardiovascular events. We will estimate the following annually over a 10-year period (2008 Â 2017) in two cohorts of patients receiving lipid-lowering therapy who 1) have documented CVD and 2) have documented CVD or diabetes but no history of myocardial infarction or stroke (i.e., 2 separate but overlapping cohorts):
- Prevalence of cardiovascular (CV) conditions overall as well as by vascular bed (coronary, cerebrovascular, and peripheral) including polyvascular disease
- Serum LDL-C and total cholesterol distribution
- Serum LDL-C and total cholesterol measurement frequency
- Patterns of lipid-lowering treatment utilization
- 1-year incidence rates of CV events (with and without revascularization)
The primary output will be prevalence proportions, mean laboratory values, and event rates over time, along with 95% confidence intervals to show uncertainty. No statistical comparisons will be made across years.
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Hospitalization rates, outcomes, and treatment intensity for elderly patients for hip fracture, acute myocardial infarction, ischemic stroke, elective aortic aneurysm repair, and heart failure — Amitava Banerjee ...
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Hospitalization rates, outcomes, and treatment intensity for elderly patients for hip fracture, acute myocardial infarction, ischemic stroke, elective aortic aneurysm repair, and heart failure
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-11
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Laura Pasea - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Folkert Asselbergs - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Kenan Direk - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Suliang Chen - Collaborator - University College London ( UCL )Outcomes:
 Hip fracture
 Myocardial infarction
 Ischaemic stroke
 Elective aortic aneurysm repair
 Heart failure Cardiovascular disease
 Death (all cause, HF-related, cardiovascular-related composite endpoint)
 GP appointments
 Outpatient appointments (all-cause)
 Emergency department attendances (all-cause)
 Hospital admissions and readmission (all-cause, HF-related, cardiovascular-related composite endpoint)
 Hospital admission length (all cause, HF-related, cardiovascular-related composite endpoint)
 Days alive out of hospital Percutaneous coronary interventions
 Coronary artery bypass graft surgery
 Heart transplant surgeryDescription: Technical Summary
The single disease model is not suited to deal with ageing populations and multimorbidity. New characterisations of diseases are required across disease silos to plan appropriate public health and policy responses. We have selected five diseases (hip fracture, acute myocardial infarction; ischaemic stroke, elective aortic aneurysm repair, and heart failure) to reflect a range of different prevention, treatment and health system approaches to gain a more complete picture across the health system. The project intends to work on complex data to better understand how to define risk factors, trajectories, outcomes and discover sub-phenotypes of multimorbidity across hip fracture, acute myocardial infarction; ischaemic stroke, elective aortic aneurysm repair, and heart failure. In addition to traditional epidemiologic analyses, unsupervised machine learning approaches such as clustering have been adopted with the intention of recognising subtypes for single diseases and for multimorbidity involving these five index diseases. Therefore, we aim:
1: To describe differences in the epidemiology of hip fracture, acute myocardial infarction; ischaemic stroke, elective aortic aneurysm repair, and heart failure in individuals age > 65 years.
2: To compare in-hospital, 90-day, and 1-year mortality across diseases and in multimorbidity.
3: To compare treatment intensity (e.g., length-of-stay, readmissions, post-acute-care utilisation) and types of treatment (e.g., consultations, outpatient visits, imaging, procedure use) for each condition.
4: Compare epidemiology, outcomes, and utilisation by socioeconomic status and multimorbidity.
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Thyroid hormone replacement therapy and the risk of major adverse cardiovascular events (MACE) among individuals with mild subclinical hypothyroidism — Samy Suissa ...
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Thyroid hormone replacement therapy and the risk of major adverse cardiovascular events (MACE) among individuals with mild subclinical hypothyroidism
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-31
Organisations:
Samy Suissa - Chief Investigator - McGill University
Oriana Hoi Yun Yu - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Christel Renoux - Collaborator - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Collaborator - McGill University
Mona Vahidi Rad - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Ronald Grad - Collaborator - McGill UniversityOutcomes:
The primary outcome of this study will be having a major adverse cardiovascular event (MACE) defined as a composite of MI, stroke (ischemic and hemorrhagic), and cardiovascular-related mortality. Secondary outcomes of this study will be heart failure (HF), renal outcomes and all-cause mortality.
Description: Technical Summary
Mild-subclinical hypothyroidism (SCH) is defined as having an elevated thyroid-stimulating hormone (TSH) level less than 10mU/L with a normal thyroxine level and has been reported to affect 5 to 10% of the population. Mild-SCH has been shown to affect an array of metabolic parameters including lipid profile, blood pressure, and body mass index. Previous studies have shown that untreated mild-SCH may be associated with an increased risk of cardiovascular-related mortality. However, there is a paucity of studies assessing whether levothyroxine treatment decreases cardiovascular events. The goal of this study will be to determine the association between levothyroxine treatment and the risk of cardiovascular outcomes and mortality among patients with mild-SCH using a population-based cohort study.
We will use the Clinical Practice Research Database (CPRD) to conduct a population-based cohort study. We will assemble a cohort of patients with no prior history of thyroid disease who have mild-SCH, based on two consecutive TSH measurements obtained within one year of each other between January 1, 1998 and December 31, 2018, with follow-up until December 31, 2019. Mild-SCH will be defined as having a TSH level between 5 and 10mU/L. Patients will be followed until having a cardiovascular event or censored at one of the following events: end of registration with the general practice, non-cardiovascular death (for outcomes other than all-cause mortality), or end of the study period (December 31, 2019), whichever comes first. We will use time-conditional propensity scores to match patients with mild-SCH who are treated with levothyroxine to those who were not treated. We will use Cox proportional hazards model to estimate hazards ratio (HR) and corresponding 95% confidence intervals (CI) for the risk of MACE associated with levothyroxine treatment versus no treatment among propensity score matched patients with mild-SCH. We will also conduct several secondary and sensitivity analyses to confirm our findings.
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Intermittent cessation of treatment for cardiovascular diseases and diabetes in breast or prostate cancer survivors and the risk of serious cardiovascular events: a matched cohort study — Ruth Brauer ...
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Intermittent cessation of treatment for cardiovascular diseases and diabetes in breast or prostate cancer survivors and the risk of serious cardiovascular events: a matched cohort study
Datasets:GP data, NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-24
Organisations:
Ruth Brauer - Chief Investigator - University College London ( UCL )
Ruth Brauer - Corresponding Applicant - University College London ( UCL )
Ian Wong - Collaborator - UCL School Of Pharmacy
Kenneth Man - Collaborator - University College London ( UCL )
Li Wei - Collaborator - University College London ( UCL )
Pinkie Chambers - Collaborator - University College London ( UCL )
Wallis Lau - Collaborator - University College London ( UCL )
Yogini Jani - Collaborator - University College London ( UCL )Outcomes:
Prescription rates of lipid-lowering, antiplatelet, antihypertensive and antidiabetic agents. ÂSerious
Cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death)Description: Technical Summary
The number of people surviving cancer has increased substantially with the predicted 10-year survival rate as high as 84% for prostate cancer and 79% for breast cancer, respectively. It is common for cancer patients to have pre-existing conditions including cardiovascular disease or diabetes which may be attributed to similar causative risk factors.
Management of pre-existing conditions is essential in assuring the best possible outcomes for cancer patients. However, when patients undergo cancer treatment adherence to existing therapies is known to reduce.
Nonadherence to medications to prevent serious CVD events is associated with increased all-cause mortality, and greater risk of all-cause hospitalization. Adherence to drugs used for the primary prevention of CVD in cancer patients is especially important as some cancer treatments are associated with increase in risk of adverse CVD events due to their cardiotoxic properties. Furthermore, patients with pre-existing diseases may be more susceptible to side-effects of their cancer treatment or may not be able to use certain cancer treatments. This in turn, may affect further their long term survival.This study therefore aims to 1) measure and compare the prescribing rates of lipid-lowering, antihypertensive, and antidiabetic agents before and after a breast or prostate cancer diagnosis and 2) to assess if continuation of cardiovascular treatment after a diagnosis of breast or prostate cancer lowers the risk of serious cardiovascular events. To achieve this, we will compare the rate of serious CVD events in cancer survivors who receive continued prescriptions for antihypertensives, antidiabetic and lipid-lowering agents with similar cancer survivors who receive intermittent treatment and measure. We will calculate an Incidence Rate Ratio (IRR) with a 95% confidence interval (CI) for the association between continuous CVD treatment after cancer diagnosis and serious CVD events using a propensity score weighted regression model.
An understanding of the impact of concomitant CVD prescribing during cancer care is pertinent in the development of strategies to improve adherence. This is particularly important considering the context of current NHS resource constraints, and the strategic direction towards limiting over-treatment/over-prescribing, especially if the gains are marginal.
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PERsonalised Medicine for Intensification of Treatment (PERMIT): the case of type 2 diabetes mellitus — Richard Grieve ...
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PERsonalised Medicine for Intensification of Treatment (PERMIT): the case of type 2 diabetes mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-31
Organisations:
Richard Grieve - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amanda Adler - Collaborator - Cambridge University Hospitals
Andrew Briggs - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Anirban Basu - Collaborator - University Of Washington
David Lugo Palacios - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
David Whitney - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
James Burns - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kamlesh Khunti - Collaborator - University of Leicester
Karla DiazOrdaz - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Paul Charlton - Collaborator - National Institute for Health Research - NIHR London Office
Qiaoling Liu - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Richard Silverwood - Collaborator - University College London ( UCL )
Stephen O'Neill - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ying-Ting Chiang - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The primary outcome for objective 1 will be HbA1c at 12 months after the onset of first-stage treatment intensification. Secondary outcomes will include: HDL, LDL, total cholesterol, BMI, SBP, DBP and eGFR also at 12 months follow-up. The secondary analyses will use data on repeated measures for each biomarker for the maximum available follow-up (up to five years). We will report the number of inpatient hospital admissions where one of the long-term outcomes of interest are reported for up to five years. We will report adherence according to defined daily dose (DDD), the time to cessation of first-line intensification, and the time to prescription of subsequent antidiabetic therapy including Âtreatment switching for example a SGLTi for a patient previously receiving a DPP4i.
Description: Technical Summary
Background: Clinical guidelines for T2DM require evidence to help personalise treatment choice. For people who require an antidiabetic drug as an Âadd on to metformin, there is controversy about whether newer, more costly classes of drug (dipeptidyl peptidase-4 inhibitors (DPP4is) or sodium-glucose cotransporter-2 inhibitor (SGLTis)) reduce the risk of long-term complications versus sulfonylureas (SUs).
Aims: This study aims to evaluate the relative effectiveness of alternative oral drug regimens for 1st stage treatment intensification for people with T2DM, and provide the evidence required to target treatments for individual patients.Objectives:
1. To assess short-term relative effectiveness according to individual risk factor profiles.
2. To calibrate and extend an existing microsimulation model for patients with T2DM in the UK (RAPIDS-UK).
3. To estimate long-term effectiveness according to individual risk factor profiles, and project the NHS budget impact of personalising drug choice.Methods: This study will use an advanced Instrumental Variable (IV) method and adapt a microsimulation model to the UK setting to provide unbiased estimates of relative effectiveness according to the individual patients risk profile. The study will apply this IV design to UK primary and secondary care data from 2011-2019.
The target population is people with T2DM prescribed SU, DPP4i or SGLT2i for 1st-stage intensification. Baseline characteristics, biomarker levels, concomitant medications, and long-term outcomes (micro- and macro- vascular complications, mortality and related hospital admissions) will be used to estimate the short-term effectiveness of the different drugs on haemoglobin A1c (HbA1c) according to individual patientÂs risk profiles (Obj 1).
We will extend a microsimulation model to calibrate long-term outcomes (follow-up to 9 years) according to those observed in primary care (Obj 2). We will predict long-term effectiveness of the treatment alternatives according to individual-level risk profiles (Obj 3), and project the budget impact of Âpersonalising the choice of 1st-stage intensification therapy.
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Identifying factors to improve management of school-age asthma in primary care: a UK population cohort study — Chloe Bloom ...
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Identifying factors to improve management of school-age asthma in primary care: a UK population cohort study
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-13
Organisations:
Chloe Bloom - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Sejal Saglani - Collaborator - Imperial College London
Zainab Khalaf - Collaborator - Imperial College LondonOutcomes:
Incidence, distribution and effectiveness (asthma attacks, asthma control and cost) of guideline-recommended interventions
Description: Technical Summary
This study will use nationally representative primary care medical records of school-age children to address the incidence, distribution, and effectiveness of annual asthma reviews, asthma management plans, inhaler technique checks and influenza vaccinations. Annual incidence will be calculated for each intervention. Logistic regression models will be used to determine the association between multiple variables and receiving the intervention. Propensity methodology and self-controlled case series will be used to assess the effectiveness of each intervention. Cost effectiveness for each intervention will also be calculated using 2019 costs.
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The use of primary care services among individuals with dementia approaching the end-of-life, and its association with multiple hospital admissions: a retrospective cohort study — Katherine Sleeman ...
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The use of primary care services among individuals with dementia approaching the end-of-life, and its association with multiple hospital admissions: a retrospective cohort study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-30
Organisations:
Katherine Sleeman - Chief Investigator - King's College London (KCL)
Javiera Leniz Martelli - Corresponding Applicant - King's College London (KCL)
Deokhee Yi - Collaborator - King's College London (KCL)
Irene Higginson - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Sabrina Bajwah - Collaborator - King's College London (KCL)Outcomes:
The primary outcome will be multiple emergency admissions to hospital in the last 90 days of life, defined based on the work of Gozalo et al. as either more than two emergency hospitalizations for any reason or more than one hospitalization for pneumonia, urinary tract infection, dehydration or sepsis in the last 90 days of life.(1) Emergency admissions will be identified through the Hospital Episodes Statistic (HES) in-patients codes using the spell start date and admission method (See Appendix 2 for codes details).
Description: Technical Summary
Background: The number of people dying with dementia in England is projected to increase x3 by 2040. Hospital admissions at the end-of-life can be deleterious and are potentially avoidable. Continuity of care with a GP and number of GP visits have been associated with lower hospital admissions in individuals with cancer. However the impact of primary care services on end-of-life hospitalizations for individuals with dementia is unknown.
Aim: To understand primary care service use and costs among individuals with dementia in the last year of life, and its association with multiple emergency hospital admissions in last 90 days of life.
Methods: Retrospective cohort study using CPRD dataset linked to HES and ONS data. Individuals with dementia who died between 2009-2019 will be included. The primary outcome is multiple emergency admissions to hospital in the last 90 days of life, an established Quality Indicator for dementia care. The number of face-to-face, telephone and home visit contacts with GP and nurses at the practice, as well as the Continuity of Care index, will be extracted from CPRD. Demographics variables (age, gender, marital status and socioeconomic position), illness-related variables (comorbidities, frailty index) and environmental variables (rate of nursing and care homes beds in CCG) will be included as covariables. A multilevel logistic regression will be used to explore association between primary care contacts and multiple hospital admissions in the last 90 days of life.
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Improving English national cancer registration using CPRD to reduce the number of Death Certificate Only cases: a descriptive feasibility study — Lucy Ellis...
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Improving English national cancer registration using CPRD to reduce the number of Death Certificate Only cases: a descriptive feasibility study
Datasets:GP data, NCRAS Cancer Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-30
Organisations:
Lucy Ellis-Brookes - Chief Investigator - National Cancer Intelligence Network - NCIN
Katherine Henson - Corresponding Applicant - Public Health England
Brian Rous - Collaborator - Public Health England
Carolynn Gildea - Collaborator - Public Health England
Catherine Welham - Collaborator - Public Health England
Chloe Bright - Collaborator - Public Health England
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Jack Anderson - Collaborator - Public Health England
Lucy Irvine - Collaborator - Public Health England
Sam Winters - Collaborator - Public Health England
Victoria Coupland - Collaborator - Public Health EnglandOutcomes:
Primary outcome: number of DCO patients with CPRD data; difference in days between the date of death as recorded by NCRAS and CPRD data; number of CPRD records with cancer coded as the medical term selected; range of consultation and observation date; number of days between consultation and observation date and date of death from the death certification; completeness of diagnosis, referral and event fields.
Secondary outcomes: number of DCO patients actively under care at the time of death; number of DCOs with a matched site between the death certification and CPRD data; proportion of match DCO-CPRD records which are referred to oncology, or to a relevant diagnostic test (as defined by Be Clear on Cancer evaluations).
Description: Technical Summary
Cancer registration data requires complete population coverage to provide unbiased, precise estimates for all cancer types, including rare cancers such as eye. The proportion of cancer registrations that are only identified using information on the death certification (DCO cases) indicate a failure to capture relevant health services information, and a high percentage indicates incomplete population coverage. The presence of DCO cases has consistently been an important marker of quality, and an increase in the availability of source documents to cancer registration staff has reduced the proportion from over 8% in the 1980s to less than 1%. However, they have not been eradicated, and a priority for cancer registration is to understand why. DCOs are routinely excluded from survival calculations. As survival estimates attempt to assess the effectiveness of the health system in treating patients with cancer, patients in which cancer is only found after death cannot contribute to this assessment. Therefore, the presence of these could bias findings, particularly in international comparisons, or regarding the examination of disparities in cancer outcomes within the UK.
During the registration process, Cancer Registration Officers (CROs) write to a GP to ask for more information when a DCO is found. Not all GPs respond. The availability of primary care information in CPRD permits investigation into these cases for the first time.
The DCO cases will be linked using the established CPRD-NCRAS linker file using the tumour identifier. Descriptive statistics (counts, proportions) will be calculated which describe: the level of ascertainment of CPRD data for DCOs; the completeness of required information to register a case; any socio-demographic bias present in matched DCO-CPRD cases. The required information to register a case is: confirmation of the cancer diagnosis; investigations undertaken; dates of diagnosis and investigations.
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Investigating the health and care needs of pregnant women with multimorbidity: A retrospective analysis of linked Primary and Secondary care data — Rhiannon D'Arcy ...
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Investigating the health and care needs of pregnant women with multimorbidity: A retrospective analysis of linked Primary and Secondary care data
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-25
Organisations:
Rhiannon D'Arcy - Chief Investigator - University of Oxford
Rhiannon D'Arcy - Corresponding Applicant - University of Oxford
Claire Carson - Collaborator - University of Oxford
Fiona Alderdice - Collaborator - University of Oxford
Marian Knight - Collaborator - University of Oxford
Sarah Hillman - Collaborator - University of WarwickOutcomes:
Prevalence of multimorbidity; Prescription of pharmacotherapy; Referral to secondary care; Use of primary care services in year before pregnancy and year after birth; New diagnosis of health condition during pregnancy or in year after birth; Gestation at first antenatal care; Unplanned admission to secondary care during pregnancy; Pregnancy outcome (livebirth, stillbirth, miscarriage); Mode of birth; Gestational age at delivery; Birthweight; Neonatal resuscitation at birth; Admission to neonatal unit; Neonatal death; Maternal health event indicating severe morbidity or near-miss; Maternal admission to level 3 care; Maternal death
Description: Technical Summary
Multimorbidity is the existence of two or more long-term health conditions in the same individual. UK-based surveillance data about death and life-threatening morbidity in pregnancy shows that women with pre-existing health conditions are more frequently affected by these outcomes. Pregnant women with multimorbidity remain an under-researched group, despite facing a disproportionate burden of morbidity and mortality.
The CPRD pregnancy register will be used to collect information on any woman who had a pregnancy between 2007-2017. Where possible, additional information about maternal and perinatal/neonatal outcomes will be obtained through the linkage of eligible women to HES, IMD scoring and ONS death registration data.
The prevalence of multimorbidity among pregnant women will be estimated, and the socio-demographic characteristics of multimorbid women will be described. Differences in maternal and perinatal/neonatal outcome between multimorbid and non-multimorbid women will be explored using odds ratios. Multivariable logistic regression will be used to explore independent factors associated with adverse outcomes. The different combinations of health conditions within the cohort and the ways they interact will be investigated using cluster analysis. Combinations of health conditions that are associated with adverse outcomes will be determined using multivariable logistic regression informed by the use of directed acyclic graphs. Multiple imputation techniques will be used to account for missing data, and to evaluate the impact of missing data on the observed associations. The most clinically relevant combinations of health conditions will be used to create a measure of severity of multimorbidity. An exploratory analysis will be undertaken to assess if the measure of severity can be used to determine individuals at greatest risk of experiencing poorer outcomes.
This study represents the starting point in establishing a comprehensive evidence-base about pregnancy and multimorbidity. It will provide novel information about a previously under-researched group, and support the development of customised maternity care.
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Natural history of knee osteoarthritis with regards to other joint sites and knee replacement: a cohort study in the UK Clinical Practice Research Datalink — Karine Marinier ...
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Natural history of knee osteoarthritis with regards to other joint sites and knee replacement: a cohort study in the UK Clinical Practice Research Datalink
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-11
Organisations:
Karine Marinier - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Karine Marinier - Corresponding Applicant - IRIS - Institut de Recherches Internationales Servier
Agnes Lalande - Collaborator - IRIS - Institut de Recherches Internationales Servier
Ghilas Boussaid - Collaborator - IVIDATA Group
Hanaya Raad - Collaborator - IT&M Stats
Siham Eltaief - Collaborator - IT&M StatsOutcomes:
Joint-specific osteoarthritis (other than knee); Primary knee replacement.
Description: Technical Summary
This proposal is for a descriptive cohort study whose objective is to describe the natural history of knee osteoarthritis (OA) in the UK, with regards to OA diagnosis at other joint sites and occurrence of knee replacement. Using data from the Clinical Practice Research Datalink (CPRD) Gold and Aurum databases linked to Practice Level Index of Multiple Deprivation as a proxy for socio-economic status, the study will include patients with incident knee OA between January 1, 1988 and December 31, 2018 and follow them until latest available data. Cumulative incidence of key outcomes of interest (OA in new joint site like the hip, foot or hand; number of sites with OA; primary knee replacement) at 1 year, 2-year, 5-year and 10-year following knee OA diagnosis, will be summarised. We will also describe the most frequent sequences of incident sites diagnosed with OA during follow-up. The survival function using Kaplan-Meier estimate will be used to analyse the time to incident OA diagnosis in other joint sites and the time to primary knee replacement following a diagnosis of knee OA. Analyses will be conducted in the whole incident knee OA population as well as in subgroups stratified on type of OA (primary, secondary or unspecified) and presence/absence of OA in other joint sites than knee at baseline, as relevant. The study will be mainly conducted in GOLD. Aurum data will be used in a second phase to gain basic familiarity with this dataset and to see in which extent findings are similar to GOLD.
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Measuring the incidence and prevalence of menstrual disorders in the UK Clinical Practice Research Datalink — Hannah Knight ...
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Measuring the incidence and prevalence of menstrual disorders in the UK Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-04
Organisations:
Hannah Knight - Chief Investigator - The Health Foundation
Elizabeth Crellin - Corresponding Applicant - The Health Foundation
Anne Connolly - Collaborator - NHS England
Christina Pagel - Collaborator - University College London ( UCL )
Ipek Gurol-Urganci - Collaborator - Imperial College London
Sarah Deeny - Collaborator - The Health FoundationOutcomes:
 Number of patients with a ÂlikelyÂ, Âprobable or Âpossible menstrual disorder
 Proportion of patients with a ÂlikelyÂ, Âprobable or Âpossible menstrual disorder who are referred to secondary care gynaecology services
 Overall healthcare utilisations as measured by:
o Number and duration of primary care consultations
o Number of prescribed products
o Number of outpatient visits
o Number of emergency department visits
o Number and duration of hospital admissionsDescription: Technical Summary
Objectives
This study aims to support GPs, gynaecologists and commissioners to understand the health service needs of patients with menstrual disorders and how these vary by clinical and socio-demographic factors.
This study will estimate the incidence and prevalence of common menstrual disorders among women of reproductive age and describe the use of primary and secondary health care by women with these conditions by age, ethnicity, socioeconomic deprivation and time.
Methods and data analysis
First, codelists (overall and by sub-condition) will be developed following best practice guidance,drawing on clinical expertise and previously published studies. This methodological work is not only an essential preparation for data analysis, but it will also guide recommendations on how diagnoses and procedures related to menstrual disorders can be better recorded into electronic databases in the future.
The finalised codelists will be applied to a random sample of 500,000 female patients (aged 8 to 60 years in 2013) with linked CPRD-HES records. This dataset will be used to:
- Estimate the incidence and prevalence of menstrual disorders in CPRD in 2013, overall and by sub-condition
- Describe the characteristics of patients who attend their GP with a menstrual disorder, by age; ethnic and deprivation profiles; type of menstrual disorder.
- Describe the treatments these patients receive in primary care over a 5-year follow-up period (2014 to 2019) and how patterns of referral to secondary care services vary according to age, ethnicity, level of deprivation and type of menstrual disorder.
- Describe and compare and levels of primary and secondary care utilisation (as captured in HES) over a 5-year follow-up period (2014 to 2019) between patients with and without a menstrual disorder.
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A primary care-based cohort study evaluating the utility of indefinite regular monitoring blood tests in detecting asymptomatic toxicity from long-term methotrexate and leflunomide prescription — Abhishek Abhishek ...
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A primary care-based cohort study evaluating the utility of indefinite regular monitoring blood tests in detecting asymptomatic toxicity from long-term methotrexate and leflunomide prescription
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-27
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Abhishek Abhishek - Corresponding Applicant - University of Nottingham
Christian Mallen - Collaborator - Keele University
Georgina Nakafero - Collaborator - University of Nottingham
Guruprasad Aithal - Collaborator - University of Nottingham
Maarten Taal - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Michael Doherty - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of Nottingham
Weiya Zhang - Collaborator - University of NottinghamOutcomes:
[1] Methotrexate discontinuation
[2] Leflunomide discontinuation
[3] Methotrexate dose reduction
[4] Leflunomide dose reductionDescription: Technical Summary
Background: Methotrexate and leflunomide are first and second-line treatments for autoimmune rheumatic diseases. They cause idiosyncratic haematological, renal, and hepatic toxicities, and, periodic blood-tests are recommended to identify such abnormalities early, so that potentially toxic drugs can be stopped before they cause damage. Small studies suggest that these abnormalities generally occur within first year of treatment and are uncommon in second year. Similarly, while more frequent monitoring tests are recommended for individuals with co-morbidities, old age etc., there are scant data to support this recommendation, and to identify people likely to benefit from closer monitoring.
Objectives:
- Estimate proportion discontinuing methotrexate or leflunomide with an abnormal blood-test result, in each 12-month period of prescription.
- Estimate proportion reducing dose of methotrexate or leflunomide with an abnormal blood-test results, in each 12-month period of prescription.
- Develop risk prediction score to identify those at risk of drug discontinuation due to abnormal blood-test result after 12-month of treatment.
- Develop risk prediction score to identify those at risk of dose reduction due to abnormal blood-test result after 12-month of treatment.Methods: Data from the Clinical Practice Research Datalink (CPRD) Gold and Aurum will be used. CPRD is an anonymised longitudinal database of UK general practice records, incepted in 1987, and includes data from over 32 million people. It includes information on demographics, lifestyle factors, diagnoses, results of investigations and prescriptions etc. People with autoimmune rheumatic diseases prescribed methotrexate or leflunomide will be ascertained from the time of their first GP prescription, and followed up electronically to estimate the proportion discontinuing or reducing the dose of treatment in each 12-month period in CPRD Gold. Cox-regression will be used to develop a risk prediction score in CPRD Gold. This will be validated in CPRD Aurum excluding any participants who are also in CPRD Gold.
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Identifying risk factors for infection with the new coronavirus (COVID-19) — Helen McDonald ...
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Identifying risk factors for infection with the new coronavirus (COVID-19)
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-25
Organisations:
Helen McDonald - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Grint - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Julia Stowe - Collaborator - Public Health England
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health EnglandOutcomes:
Primary: Laboratory-confirmed infection with novel coronavirus (SARS-CoV-2)  indicated by inclusion in Public Health England COVID-19 Âfirst few hundred case dataset.
Secondary outcomes:
 Severe pneumonia (requiring admission to intensive care) due to laboratory-confirmed infection with novel coronavirus (SARS-CoV-2).
 Prevalence among the general population of underlying health conditions which are being considered as possible risk factors for COVID-19.Description: Technical Summary
This study will describe associations between underlying health conditions and early COVID-19 infections in England, compare the profile of underlying health conditions among COVID-19 pneumonia requiring ITU admission to those for severe pneumonia of other causes, and describe the prevalence of these conditions among the general population in England.
For the first two aims, a case-control study design will be used, with two control groups. Cases will comprise the Âfirst few hundred COVID-19 cases in England, January-March 2020, using a depersonalised dataset from Public Health England.
For the main analysis, controls will be the general population active in CPRD, January-March 2019. Potential risk factors will be chronic heart, respiratory, kidney, neurological and liver diseases, immunosuppression, asthma requiring medication, malignancy, organ transplant recipients, pregnancy and smoking status. A secondary analysis we will compare COVID-19 cases admitted to ITU with pneumonia to controls admitted to ITU with pneumonia in January - March 2019. Both analyses will use multivariable logistic regression to calculate odds ratios adjusted for age, sex, ethnicity, region and deprivation.
Among individuals eligible to be selected as general population controls, summary data of the prevalence of the underlying health conditions stratified by age, sex and region will be described to enable findings to be used in modelling to inform policy responses to COVID-19.
The results will inform planning for the demand on health services during the COVID-19 pandemic, and Public Health EnglandÂs advice to the public and government about the risk of COVID-19 for people with underlying health conditions.
Source -
Investigation of common mechanisms and clinical pathways in cardiovascular diseases and dementia — Hugh Markus ...
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Investigation of common mechanisms and clinical pathways in cardiovascular diseases and dementia
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-03-11
Organisations:
Hugh Markus - Chief Investigator - University of Cambridge
Steven Bell - Corresponding Applicant - University of Cambridge
Bernard Cho - Collaborator - University of Cambridge
Christopher Osuafor - Collaborator - University of Cambridge
Duncan Edwards - Collaborator - University of Cambridge
Elias Allara - Collaborator - University of Cambridge
Eric Harshfield - Collaborator - University of Cambridge
Joel Gibson - Collaborator - University of Cambridge
Luanluan Sun - Collaborator - University of Cambridge
Robin Brown - Collaborator - University of CambridgeOutcomes:
Abdominal aortic aneurysm; Atrial fibrillation; Atrioventricular block, complete; Atrioventricular block, first degree; Atrioventricular block, second degree; Cardiac arrest; Coronary heart disease not otherwise specified; Dementia; Dilated cardiomyopathy; Heart failure; Hypertrophic cardiomyopathy; Intracerebral haemorrhage; Ischaemic stroke; Myocardial infarction; Other cardiomyopathy; Peripheral arterial disease; Primary pulmonary hypertension; Pulmonary embolism; Secondary pulmonary hypertension; Stable angina; Stroke not otherwise specified; Subarachnoid haemorrhage; Subdural haematoma - nontraumatic; Supraventricular tachycardia; Thrombophilia; Transient ischaemic attack; Trifascicular block; Unstable angina; Venous thromboembolic disease (excluding pulmonary embolism); Ventricular tachycardia.
Description: Technical Summary
We will examine associations of known and novel risk factors, plus their interaction, with the onset and prognosis of cardiovascular diseases (CVD) and dementia, evaluate the efficacy of existing medications (and any medications that have potential to be used Âoff-label based on external bioinformatics analyses) to treat these conditions, and develop and evaluate (dynamic) models to enhance clinical prediction for risk and evolution of CVD and dementia. This includes within specific currently underserved patient groups (e.g. cancer survivors) and as yet unidentified subgroups. Statistical approaches that we will use include Cox proportional-hazards regression, linear and logistic regression models (including conditional or Prentice-weighted methods for case-cohort analyses), as well as more complex manifestations of these within a machine-learning framework (supervised and unsupervised methods, e.g. support vector machines, random forests, regression trees, ensemble/"super" learning, mixture models/latent class analysis, artificial neural networks and Âdeep learning methods) to explore symptom/disease clustering and develop/refine risk prediction algorithms. Alongside primary care data obtained from CPRD, Hospital Episode Statistics (HES) data and Office of National Statistics (ONS) mortality data will be used to determine hospitalisations and deaths attributed to each outcome. We will use previously published code lists for products and diagnoses.
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Characterising patterns of multimorbidity in individuals with diabetes for clinical guideline development and healthcare usage evaluation — Imperial College Health Partners...
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Characterising patterns of multimorbidity in individuals with diabetes for clinical guideline development and healthcare usage evaluation
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request:. Commercial
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To derive novel consumer insights to better understand patient needs and preferences for engagement including information on discrepancies in patient need and service provision. — Imperial College Healthcare NHS Trust...
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To derive novel consumer insights to better understand patient needs and preferences for engagement including information on discrepancies in patient need and service provision.
Legal basis:De-identified Data Access Request:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: De-identified Data Access Request:. commercial
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Does North West London Chronic heart failure care in adults vary by GP practice and patient group? A historical cohort study — Imperial College Healthcare NHS Trust...
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Does North West London Chronic heart failure care in adults vary by GP practice and patient group? A historical cohort study
Legal basis:ResearchåÊ
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Mar-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart FAILURE. commercial
Source
2020 - 02
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Mental health and self harming behaviours of prisoners in Wales — unknown...
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Mental health and self harming behaviours of prisoners in Wales
Where: unstated
When: 2020-2-18
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This research aims to investigate mental health and self-harming behaviours among prisoners in Wales. It will compare the prevalence/incidence of mental health diagnoses or self-harm between prisoners and non-prisoners (from the general population with comparable age and sex in Wales), while exploring the risk factors for developing mental illnesses.
Routinely collected prison data will be anonymously linked and made available to in the SAIL databank to researchers working on this project. Data will be used to explore whether prisoners have been diagnosed with mental health conditions or recorded self-harming behaviours before they entered prison, whether they develop these conditions or behaviours during their imprisonment time, and how these are affected on release. The findings of the study will improve understanding of self-harm and mental health in prisoners in Wales, thereby improving the mental health services provided to the prisoners during imprisonment and on release..
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Mental health and self-harming behaviours in university students: Risk factors and trajectories — unknown...
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Mental health and self-harming behaviours in university students: Risk factors and trajectories
Where: unstated
When: 2020-2-12
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This research project Investigates mental health (diagnosis and symptoms) and self-harm among university students in Wales. It will examine studentsâ prior diagnoses, symptoms and contacts with services alongside studentsâ trajectories for mental health (symptoms and diagnoses) and health-related outcomes.
There are growing concerns about university studentsâ mental health such as depression, anxiety, eating disorders and self-harming behaviours. As far as we know, this is a unique study exploring mental health conditions and self-harm among university students in Wales. The study aims to fill the gap in what we know about studentsâ mental health. We will use data from SAIL databank to find out whether students have struggled with mental health conditions before they started university, develop these conditions or different ones during their studies, and how their mental health change after leaving the university. We will also look at how their physical health is affected or affects their mental health. These findings will be useful to have a better understanding of mental health problems among university students in Wales to inform service provision and policy.
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Understanding participation in post-compulsory education and training — unknown...
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Understanding participation in post-compulsory education and training
Where: unstated
When: 2020-2-10
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This project aims to examine how pathways to post-compulsory education vary between different groups of pupils. Areas of specific interest include the progression of pupils from Welsh medium schools and how these pathways vary by socio-economic characteristics such as gender, free-school meal status, ethnicity and those with special educational needs.
This research project will analyse how individuals who are resident in Wales progress through secondary school, into sixth forms and on to further education colleges for post-16 education. This research will look at the transitions of pupils from school to post-compulsory education and training in Wales. It will look at the levels of retention in Wales, and examines what influences Year 11 pupils to go into post-compulsory education in Wales.
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Exploring the impact of the Welsh school-based counselling strategy — Professor Ann John and Jo Mcgregor...
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Exploring the impact of the Welsh school-based counselling strategy
Where: unstated
When: 2020-2-13
Opt Outs: no information provided./p>
Who: Professor Ann John and Jo Mcgregor, Swansea University (ADR Wales).
Datasets:see text
Why: This research will assess the impact (recording of depression, anxiety and psychotropic medications) of the Welsh Government delivery of counselling services in all secondary schools across Wales.
Counselling, delivered by a professionally trained workforce, is increasingly seen as an effective early intervention for young people who have emotional, behavioural or social problems, and has been adopted in Wales. Primary care often represents the first point of contact with healthcare services and is an important source of care for young people with common mental disorders, such as depression and anxiety.
In 2010 the Welsh Government commissioned a research consortium led by the British Association for Counselling and Psychotherapy and the University of Strathclyde to undertake an evaluation of its school-based counselling strategy. The evaluation found that implementation of the Strategy and its counselling services was generally seen as successful by all stakeholders, including counselling clients, with evidence that all key recommendations for its development were implemented. Welsh Government seeks further evidence from routinely collected data sources to further assess the impact of this strategy and inform future decisions regarding the establishment of secure streams of funding for this policy and also the potential for roll out into the primary schools sector.
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Extending opportunities for prevention of suicide — unknown...
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Extending opportunities for prevention of suicide
Where: unstated
When: 2020-2-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This project aims to answer two overarching research questions:
How many different medications do suicide decedents typically take and what health conditions are these intended to treat? What proportion of total suicide deaths is represented by people taking psychotropic medications in relation to controls? Do suicide decedents change their usual pattern of filling prescriptions in the period right before death? Are filling patterns less frequent or more erratic in the year of death? Filling patterns will be compared to those of live controls who are likewise on medications.This project will link dispensing data to the Welsh Suicide Information Database (SID-Cymru) to examine patterns of prescription and dispensing among people who died by suicide. It builds on a previous project examining health service utilisation before death.
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Exploring associations between mental health disorders and patterns of education — unknown...
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Exploring associations between mental health disorders and patterns of education
Where: unstated
When: 2020-2-17
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: The aim of this study is to explore educational attainment, levels of school absenteeism and exclusion in Welsh children and young people diagnosed in their electronic health records with at least one of the following: attention deficit hyperactivity disorder (ADHD), alcohol and drugs misuse, anxiety, autistic spectrum disorder (ASD), bipolar disorder, conduct disorder, depression, eating disorders, learning difficulties, other psychotic symptoms, schizophrenia, self-harm behaviour.
Associations between mental health disorders and poor school outcomes, high levels of absenteeismm and school exclusions have been reported in surveys and small cohorts in England and further afield. We have the opportunity to explore these issues using linked routinely collected health and education datasets of the Welsh population available via the Adolescent Mental Health Data Platform (ADP) in Swansea University.
Source -
Assessing the effectiveness of ESF-funded labour market programmes in Wales —
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Assessing the effectiveness of ESF-funded labour market programmes in Wales
Where: unstated
When: 2020-2-10
Opt Outs: no information provided./p>
Who: Rhys Davies, Cardiff University, Wales Institute of Social & Economic Research, Data & Methods (ADR Wales).
Datasets:see text
Why: To identify which types of labour market interventions, such as careers guidance, basic skills training or training in job search skills, have the greatest impact upon participants in ESF funded training programmes. The effectiveness of these schemes will be examined among different groups of participants, such as those recently made redundant, the long term unemployed and the economically inactive.
This project assesses the effectiveness of European Social Fund (ESF) funding focused on developing skills for employment, asking whether or not these programmes have a demonstrable effect on the outcomes of participants. The focus of the analysis is to consider whether participation in ESF projects can be associated with an increase in the likelihood of those participants who were previously out of work gaining employment subsequent to ESF funding compared to a group of otherwise comparable people from the wider population.
Source -
Access to dental and orthodontic services in Northern Ireland after policy change —
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Access to dental and orthodontic services in Northern Ireland after policy change
Where: unstated
When: 2020-2-13
Opt Outs: no information provided./p>
Who: Professor Ciaran OâNeill, Queenâs University Belfast (ADR Northern Ireland).
Datasets:see text
Why: The primary aim is to compare the levels of and socioeconomic gradient in publicly funded general dental practitioner services for children/adolescents in the four years preceding the introduction of an objective measure of need for orthodontic care in 2014 with the four years following this change. This will effectively act as a policy evaluation, allowing policymakers to understand the impact or lack thereof of policy versus its intended impact and utility.
A strand within this project will specifically examine the migrant and ethnic minority population with regards to dental and orthodontic treatment uptake.
There exists a stark difference in the pattern of publicly funded oral healthcare delivered through general dental practice in Northern Ireland related to social class. To address this, an objective measure of need governing access to publicly funded orthodontic care was introduced in 2014 (Index of Orthodontic Treatment Need, IOTN). This project will bring together the 2011 Census with the Dental Reimbursement Database from Business Services Organisation (BSO).
Source -
The role of careers guidance in supporting participation in higher education — unknown...
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The role of careers guidance in supporting participation in higher education
Where: unstated
When: 2020-2-10
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This project aims to examine whether careers guidance is received by those who are most in need of support and whether the receipt of careers guidance can be demonstrated to be associated with increased rates of progression, attainment and retention in post-compulsory education.
This research will utilise administrative records supplied by Careers Wales to examine the receipt of careers guidance received by children in Welsh schools and how this is influenced by pupilsâ demographic and academic characteristics.
Source -
Association between mental health disorders and patterns of education in children & young people — unknown...
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Association between mental health disorders and patterns of education in children & young people
Where: unstated
When: 2020-2-20
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Associations between mental health disorders and poor school outcomes, high levels of absenteeism, and school exclusions have been reported in surveys and small cohorts in England and further afield. This project will explore these issues using linked routinely collected health and education datasets of the Welsh population available via the Adolescent Mental Health Data Platform (ADP) in Swansea University.
Source - and 20 more projects — click to show
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Incidence of Sexually Transmitted Infections (STIs) in the UK Primary Care Setting — Martin Gulliford ...
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Incidence of Sexually Transmitted Infections (STIs) in the UK Primary Care Setting
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-18
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Emma Rezel-Potts - Corresponding Applicant - King's College London (KCL)
Jackie Cassell - Collaborator - Brighton and Sussex Medical SchoolOutcomes:
1)Â Â Â Â Overall STI incidence rate per year.
2) Incidence rate ratios and their confidence intervals for males and females separately and by age, ethnicity, IMD of patient, IMD of practice and region of practice per year.
3) Rate per year for all consultations involving STI diagnoses, testing and management.
4) Testing rates per year will be estimated for males and females, for all ages and grouped by age; also for ethnic group, IMD of patient, IMD of practice and region of practice.
5) Positive testing percentage overall and by sex, age, ethnicity, IMD of patient, IMD of practice and region of practice. *
6) % positive tests treated. *
7) % positive tests referred. *
8) % positive tests given partner notification service. *
9) % positive tests given health promotion services. **Outcomes 5-9 subject to the assessment of the feasibility of measuring these using CPRD records.
Description: Technical Summary
Background and rationale:
There were 447,694 new diagnoses of STIs in specialist sexual health services (SHSs) in England in 2018, an increase of 5% from 2017. Non-commissioned primary care providers are not required to contribute to the Genitourinary Medicine Clinic Activity Dataset (GUMCAD) STI Surveillance System - the mandatory reporting system for STI diagnoses. Therefore, the extent of STI testing, diagnoses, prescribing and other management within UK primary care is not well understood. Studies looking at individual STIs suggest that general practitioners are contributing to STI management but a recent survey among GPs suggest that they do not consistently adhere to standards of STI management. CPRD can be used to improve understanding of the STI testing, diagnoses and management taking place within primary care. This will first require the establishment of the quality of the recording of STI activity in the CPRD.
Objectives:
To describe the quality of data recording on STI testing, diagnoses and management in CPRD records.
To describe the incidence and management of a comprehensive list of STIs in the UK primary care setting using the CPRD.
Methods:
Cohort study to determine the testing rate and diagnosis rate using analysis of READ codes in CPRD records from 2010 to 2019 corresponding to PHEÂs list of new STI diagnoses.
Analysis:
1. Poisson models, with person years as the offset, to estimate incidence rate ratios and their confidence intervals for males and females separately and by age, ethnicity, IMD of patient, IMD of practice and region of practice.
2. The incidence rate epidemiology estimated from CPRD records and compared with national surveillance data collected by PHE.
3. The consultation rate for all STI consultations estimated from the CPRD records.
4. Testing rates estimated for males and females, for all ages and grouped by age (16-44, >44 years).
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Incidence, prevalence, treatment patterns and health care resource use of women with vasomotor symptoms in the UK: A descriptive study using electronic medical records — Amit Kiran ...
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Incidence, prevalence, treatment patterns and health care resource use of women with vasomotor symptoms in the UK: A descriptive study using electronic medical records
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-10
Organisations:
Amit Kiran - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Bas van der Poel - Collaborator - Astellas Pharma Europe Ltd. - UK
Matthias Stoelzel - Collaborator - Astellas Pharma Europe Ltd. - UKOutcomes:
VMS cases (for incidence and prevalence calculations); Treatment patterns (hormonal, non-hormonal, or no treatment) for calculating the proportion of patients first line treatment (within12months post VMS diagnosis); Treatment patterns (eight treatment groups) for reporting sequential lines of treatment post VMS diagnosis (over the follow-up period); Medication Possession Ratio as a proxy measure for adherence; Duration of treatment (persistence) for first line of treatment post VMS diagnosis over follow-up period; Healthcare resource utilisation including number of GP visits, hospital outpatient visits, inpatient admissions, diagnostic tests, procedures, and length of stay in hospital.
Please also see Section N for more details.
Description: Technical Summary
Women of menopausal age, typically 40-65 years, can experience hot flushes, night sweats and related symptoms, collectively known as vasomotor symptoms (VMS). These symptoms have been reported to persist for a median of 4.5years after a womanÂs final menstrual period [Avis et al, 2015]. Whilst hormone replacement therapy (HRT) are commonly prescribed for symptomatic relief, HRT may not always be the appropriate choice, due to contraindications or high-risk of treatment related adverse events such as stroke, breast cancer and coronary heart disease (nonfatal myocardial infarction)].
There has been limited reporting of the real world treatment landscape for women with VMS, which is needed for foundational insight on the management of VMS.
This study aims to describe the incidence, prevalence, treatment patterns and health care resource use of women with VMS. This is a descriptive study using the most recent 10 years of linked electronic medical records from the UK (Gold).
VMS cases will be captured using Read code diagnosis, and will be described in terms of their patient characteristics and a-priori selected comorbidities. The annual incidence rate of VMS among the general population of woman of menopausal age will be estimated, along with annual point prevalence of VMS. For incident cases, the first line treatment received (hormonal, non-hormonal, no treatment) post VMS diagnosis will be reported, as well as subsequent treatment pattern in their patient history. The duration of first line treatment (persistence) will be described, along with a proxy measure for treatment adherence (medication possession ratio).
In addition, in a subset of English patients eligible for linkage with HES data, the health care resource use of VMS cases will be described and will include the number of hospital outpatient visits, number of inpatient admissions, total length of stay in hospital for the inpatient admissions for menopause related symptoms.
Source -
Time Trends in identification of Autism Spectrum Disorders — Ginny Russell ...
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Time Trends in identification of Autism Spectrum Disorders
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-10
Organisations:
Ginny Russell - Chief Investigator - University of Exeter
Sally Stapley - Corresponding Applicant - University of Exeter
Andrew Salmon - Collaborator - University of Exeter
Anita Pearson - Collaborator - NHS England
Tamsin Ford - Collaborator - University of Cambridge
Tamsin Newlove-Delgado - Collaborator - University of ExeterOutcomes:
Percentage (%) of children, adolescents and adults with a new record of an autism diagnoses in each year (1998-2018).
Autism incidence will be obtained by dividing the number diagnosed as autistic by the number with acceptable data in the population. At each age-band (either preschool, child, adolescent or adult) incidence will be the number of patients with a new diagnosis divided by the total number of patients active in the study population in the age-band for that year, a method in common with Taylor et al. (2009).
Description: Technical Summary
The objectives are to explore time trends in the diagnosis of ASD from 1998 to 2018. We are concerned not with absolute prevalence of autism, but of autism diagnosis as recorded in primary care itself. Our focus is on trends in recognition of autism, rather than on autism incidence and prevalence per se.
We will examine ASD using all relevant diagnostic codes (Appendix 1). This study will be largely descriptive, focussed on Âpainting a picture of the current situation revealed by UK primary care data, rather than undertaking detailed comparative analysis or any attempt to define causal links.
Based on available evidence, we anticipate the number of people of any age receiving any ASD diagnosis will be increasing, year on year.
For separate developmental stages we have separate hypotheses:
1/ That the modal age of diagnosis in the pre-school age group (0 Â 5 years) is dropping as awareness of early diagnosis of autism increases and diagnostic tools improve.2/ That an increase in diagnosis in the adolescent (12 - 19 years) and adult groups will be largely driven by the increase in diagnoses of AS and HFA.
3/ In adults (over 19 years) a sharp rise is anticipated in previously undiagnosed AspergerÂs with a peak after the Autism Act (2009) required all local authorities to provide adult assessment for autism.
We will also explore the age-distribution of diagnoses to examine whether there are peaks in diagnosis  for example at transition from nursery to primary school (age 4) and to secondary school (age 11). Here difficulties in adjusting to a new environment or new set of expectations will necessitate increased support precipitated by diagnosis.
We hypothesise that diagnoses of HFA will increase more than SA over the twenty years based on findings of a similar US study in 2002.
Source -
Multimorbidity and clinical guidelines: using epidemiology to quantify the applicability of trial evidence to inform guideline development — Bruce Guthrie ...
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Multimorbidity and clinical guidelines: using epidemiology to quantify the applicability of trial evidence to inform guideline development
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-17
Organisations:
Bruce Guthrie - Chief Investigator - University of Edinburgh
Bruce Guthrie - Corresponding Applicant - University of Edinburgh
Chris Hall - Collaborator - University of Dundee
Clare MacRae - Collaborator - University of Edinburgh
Daniel Morales - Collaborator - University of Dundee
David McAllister - Collaborator - University of Glasgow
David Moreno Martos - Collaborator - University of Dundee
Emily Jefferson - Collaborator - University of Dundee
Magalie Guignard-Duff - Collaborator - University of Dundee
Megan McMinn - Collaborator - University of Edinburgh
Shahzad Mumtaz - Collaborator - University of Dundee
Sohan Seth - Collaborator - University of Edinburgh
Stewart Mercer - Collaborator - University of Edinburgh
Zsolt Szarka - Collaborator - University of DundeeOutcomes:
Initial descriptive analysis
(1) Prevalence of multimorbidity defined as two or more chronic conditions, and defined as âcomplex multimorbidityâ using definitions proposed in the literature (eg 3+ chronic conditions, 3+ conditions from 3+ body systems, physical-mental health multimorbidity)
(2) Prevalence of polypharmacy defined as 5+, 10+ and 15+ drug classes prescribed in the previous 56 days
Examination by trial exclusion
(1) The prevalence of comorbidity (total number or comorbidities; number of concordant and discordant comorbidities; number of physical and mental health comorbidities);
(2) The prevalence of co-prescribing (total number of drugs currently prescribed; number from a different BNF chapter than the index condition);
(3) The electronic Frailty Index score and Charlson Index (both are cumulative morbidity scores which are predictive of future mortality, hospital admission and care home admission);
(4) The prevalence of significant interactions between the drug evaluated by the trial (if applicable) and comorbidities (based on British National Formulary [BNF] advice about relative and absolute contraindications to the target drug);
(5) The prevalence of significant interactions between the drug evaluated by the trial (if applicable) and currently co-prescribed drugs (based on BNF identified interactions with potentially serious consequences);
(6) Rates of common adverse drug effects (eg falls and injury related to falls, bleeding, constipation, acute kidney injury, postural hypotension or low blood pressure)
(7) Mortality from the index condition and from other conditions.Description: Technical Summary
We will examine the prevalence of multimorbidity (defined as having two or more health conditions), and polypharmacy (defined by the total number of drugs currently prescribed using existing commonly used cut-offs of 5+, 10+ and 15+ drugs) among a cross-section of patients acceptable for use in research within CPRD, including examining how prevalence varies by age, gender, and socioeconomic deprivation. We will then define patients with both prevalent and recently diagnosed index conditions and determine whether they would have been eligible for inclusion in clinical trials of treatments for that index condition that are relevant to clinical guidelines. For each index condition, we will then compare those eligible and those ineligible in terms of:
- The proportion of patients that would have been eligible for each clinical trial of treatment;
- Differences in patient characteristics in terms of the total number of comorbidities, the number of concordant and discordant comorbidities, the number of physical and mental health comorbidities, frailty measured by the electronic Frailty Index, weighted comorbidity measured by the Charlson Index, prescribing drug count/polypharmacy, and A&E attendance (stratified by age, gender, ethnicity, and socioeconomic deprivation)
- The prevalence of significant interactions between the drug evaluated by the trial and comorbidities based on advice about relative and absolute contraindications to the target drug
- The prevalence of significant interactions between the drug evaluated by the trial and currently co-prescribed drugs based on identified interactions with potentially serious consequences
- Rates of common adverse events of the drug evaluated by the trial (eg falls and injury related to falls, bleeding, constipation, acute kidney injury, postural hypotension or low blood pressure)
- Mortality from the index condition and other health conditions over different pre-specified time periods.
Source -
Determinants of treatment patterns of ParkinsonÂs Disease in the United Kingdom — Loes Rutten...
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Determinants of treatment patterns of ParkinsonÂs Disease in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-13
Organisations:
Loes Rutten-Jacobs - Chief Investigator - Roche
Loes Rutten-Jacobs - Corresponding Applicant - Roche
Preciosa Coloma - Collaborator - Roche
Spyros Roumpanis - Collaborator - F. Hoffmann - La Roche LtdOutcomes:
Initiation of PD symptomatic treatment (overall and per treatment class)
- Switch or add-on of PD symptomatic treatment
- Time to titrate to dopa or dopa derivative stable doseDescription: Technical Summary
The study aims to describe the treatment patterns of ParkinsonÂs Disease (PD) in the United Kingdom (UK) and to identify determinants of these treatment patterns. A cohort of patients with PD will be constructed from Clinical Practice Research Datalink (CPRD) data. Incident PD patients with a diagnosis code in CPRD data between 1 January 2007 and 31 March 2018 will be included. Kaplan-Meier estimates will be calculated for time to first symptomatic treatment overall and per treatment class and time to first switch or add-on treatment. Furthermore, Cox proportional-hazards regression analyses will be used to evaluate potential determinants of these time-to-event outcomes. Results will be presented overall and stratified by age groups, sex and calendar year.
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Aclidinium Bromide PASS to Evaluate the Risk of Cardiovascular Endpoints: Stroke and Acute Myocardial Infarction — CRISTINA REBORDOSA GARCIA ...
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Aclidinium Bromide PASS to Evaluate the Risk of Cardiovascular Endpoints: Stroke and Acute Myocardial Infarction
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-18
Organisations:
CRISTINA REBORDOSA GARCIA - Chief Investigator - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Corresponding Applicant - RTI Health Solutions
Alejhandra Lei - Collaborator - Astra Zeneca Ltd - UK Headquarters
Annalisa Rubino - Collaborator - Evidera, Inc
Christine Bui - Collaborator - RTI Health Solutions
David Martinez - Collaborator - RTI Health Solutions
Elena Rivero-Ferrer - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Joan Forns Guzman - Collaborator - RTI Health Solutions
Nuria Saigi - Collaborator - RTI Health Solutions
Sami Daoud - Collaborator - Astra Zeneca Ltd - UK Headquarters
Susana Perez-Gutthann - Collaborator - RTI Health SolutionsOutcomes:
The following outcomes will be measured:
? Hospitalisation for acute myocardial infarction, either non-fatal or fatal, plus community (out-of-hospital) coronary heart disease deaths
? Acute stroke, either non-fatal or fatal, including community (out-of-hospital) cerebrovascular disease deaths
We propose to use standard clinical definitions similar to those that have been used in prior studies [1-4]:
? An AMI is defined by the evidence of myocardial necrosis in a clinical setting consistent with myocardial ischaemia, including ST elevation myocardial infarction and nonÂST elevation myocardial infarction. Because one-third of the patients suffering an AMI die suddenly before arriving at the hospital, community CHD deaths are also included in the definition of AMI. Community death from CHD will be defined as sudden cardiac death or fatal myocardial infarction deaths in persons outside a hospital setting.
? An acute stroke is defined as the rapid onset of a persistent neurological deficit attributed to an obstruction or rupture of the arterial system supplying the brain. Because some patients having a stroke will die before arriving at a hospital facility, community deaths from CeVD will be ascertained.
Ascertainment of the study outcomes in CPRD is described in Section N.Description: Technical Summary
This cohort study aims to evaluate the risk of hospitalisation for AMI and stroke in patients initiating aclidinium and other study medications as compared to patients initiating LABA and in patients initiating other COPD medications as compared to patients initiating aclidinium. The study cohort consists in patients aged ?40 years with COPD initiating aclidinium or other COPD medications in the CPRD Aurum in the UK between 2012 and 2019. All confirmed cases of hospitalisation for AMI and stroke will be included in the cohort study. Exposure to study medications will be ascertained through recorded prescriptions in the CPRD Aurum. The outcomes AMI and stroke will include out-of-hospital coronary heart disease (CHD) death (CHD) and cerebrovascular disease (CeVD) death, respectively. AMI and stroke events and date, and diagnosis for comorbidities of interest, will be defined based on information from the CPRD Aurum and from the inpatient Hospital Episode Statistic (HES) dataset and the Office for National Statistics (ONS). Statistical analysis will include: 1) descriptive statistics of the cohort; 2) cohort analysis to compare risk of AMI and stroke associated with the use of aclidinium and other COPD medications versus LABA, and the risk associated with other COPD medications versus the risk associated with aclidinium: Crude and adjusted RRs and 95% CIs will be estimated for each potential confounding and risk factor; 3) Patient subgroup analyses (stratified by subgroups of interest): risk ratios (crude and adjusted) will be estimated among current users of each study medication; 4) effect of duration (short or long) will be estimated among current users of each study medication.
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Association of diabetes control on the risk of venous thrombosis: a nested case control study — Susan Jick ...
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Association of diabetes control on the risk of venous thrombosis: a nested case control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-27
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Sarah Charlier - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Claudia Becker - Collaborator - University of BaselOutcomes:
Primary outcome: Venous Thromboembolisms (VTE)
Description: Technical Summary
Venous thromboembolism (VTE) is a medical condition in which a blood clot (a thrombus) forms in a vein of the leg or pelvis, and either causes a deep vein thrombosis (DVT), or the thrombus travels to the pulmonary arteries and causes a pulmonary embolism (PE). The term VTE therefore includes DVT and PE. VTE is a dangerous condition and an important cause of death. Its prevention and management is a priority for the National Health Service (NHS).
Since diabetes type 1 (T1DM) and type 2 (T2DM) affect over 450 million patients worldwide (8.8%), diabetes and its related complications are of great importance for society and the health system.
DM is suspected to be a risk factor for VTE as VTE occurs more often in individuals with DM. However, to date, few studies have assessed the impact of blood sugar control (measured as HbA1c levels) on the risk of VTE in patients with DM types 1 and 2. Additionally, available studies on the topic yielded conflicting results. While some studies found an association between the HbA1c level and the risk of VTE, others did not.
Our objective is therefore to analyse the association between the HbA1c level (i.e., the primary exposure of our study) and the risk of VTE (i.e., our outcome of interest) separately for patients with DM type 1 and 2.We will perform a nested case-control analysis within a cohort of DM patients using data from the Clinical Practice Research Datalink GOLD. The study period will cover 1995 through 2018. Cases will be T1DM or T2Dm patients who suffered a VTE and we will match 4 controls to each case from the population of patients with T1DM or T2DM, respectively.
We will use conditional logistic regression analyses in order to calculate odd ratios with 95% confidence intervals among different HbA1c levels and different medication schemes in cases and controls.
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SELECT: Selection of Eligible People for Lung Cancer Screening using Electronic Primary Care DaTa: Validation of pre-existing prediction models — David Baldwin ...
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SELECT: Selection of Eligible People for Lung Cancer Screening using Electronic Primary Care DaTa: Validation of pre-existing prediction models
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-28
Organisations:
David Baldwin - Chief Investigator - Nottingham University Hospitals
Aamir Khakwani - Collaborator - University of Nottingham
David J. Brown - Collaborator - Nottingham Trent University
Graham Ball - Collaborator - Nottingham Trent University
Helen Morgan - Collaborator - University of Nottingham
Jaspreet Kaur - Collaborator - University of Nottingham
Jun He - Collaborator - Nottingham Trent University
Libby Ellis - Collaborator - University of Nottingham
Mufti Mahmud - Collaborator - Nottingham Trent University
Rachael Murray - Collaborator - University of Nottingham
Richard Hubbard - Collaborator - University of Nottingham
William Hamilton - Collaborator - University of ExeterOutcomes:
Discrimination of the models (AUC)
Calibration of models
Decision analysis at pre-specified thresholdsDescription: Technical Summary
Objectives:
The overall aim of this project is to determine if primary care data can be used to develop improved risk prediction models for selecting individuals for low dose CT screening for lung cancer? Specific research objectives are:
1. To develop a series of mathematical models using data from patients one, two and three years prior to lung cancer diagnosis.
2. To examine for differences between models, including analysis of variation when stratifying lung cancer into early and late stage, pathological subtype and by route to diagnosis.
3. To compare the predictive performance in the external validation datasets and the eligibility rates between the new model(s), the PLCOM2012 and the LLPv2 models over a range of risk thresholds.
4. To assess the cost effectiveness of the models at varying risk thresholds.Methods and data analysis:
a. A longitudinal cohort will be determined using CPRD with patients identified between 01/01/2000 until 31/12/2015 who have been contributing to CRPD for at least 12 months after their first registration. All cases with at least one Read code for lung cancer in CPRD who have research quality data will be included and the whole of CPRD with no diagnosis of lung cancer aged 40 years or older will be the comparator group (Sections K and L).
b. Patient demographic features, all symptoms, diagnoses, investigations and drug prescriptions will be classified and used to produce a risk prediction model.
c. This model will be externally validated and cost effectiveness analysis will be performed using microsimulation modelling.
d. The best performing pre-existing models will be externally validated in the CPRD cohort (namely the Liverpool Lung Project Version 2 Â LLPv2 and Prostate, Lung, Colorectal and Ovarian cancer model (PLCOm2012).
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Screening for diabetes and glucose intolerance disorders after gestational diabetes in primary care: A retrospective cohort analysis from the UK Clinical Practice Research Datalink (CPRD) — Simon Griffin ...
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Screening for diabetes and glucose intolerance disorders after gestational diabetes in primary care: A retrospective cohort analysis from the UK Clinical Practice Research Datalink (CPRD)
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-27
Organisations:
Simon Griffin - Chief Investigator - University of Cambridge
Rebecca Dennison - Corresponding Applicant - University of Cambridge
Britt Kilian - Collaborator - University of Cambridge
Efthalia (Lina) Massou - Collaborator - University of Cambridge
Juliet Usher-Smith - Collaborator - University of Cambridge
Simon Griffin - Collaborator - University of CambridgeOutcomes:
Primary outcome: record of diabetes screening tests (using any test).
Secondary outcomes: types of test used, factors associated with attendance, diagnoses of diabetes or glucose intolerance disorders.Description: Technical Summary
Background
Gestational diabetes (GD) affects nearly a fifth of pregnancies in the UK, and puts mothers at an eight-fold higher risk of developing type 2 diabetes than women with normal glucose tolerance in pregnancy. National Institute for Health and Clinical Excellence (NICE) guidelines recommend that women are screened for diabetes at six to 13 weeks after pregnancy and then once a year thereafter to allow early diagnosis and management of incident diabetes. However, uptake is poor, particularly in the long term, and no large studies have reported screening rates after three years postpartum in the UK.
Aims
We therefore aim to describe diabetes screening practices in UK primary care in the long term after GD. We will also determine whether attendance varies by maternal and practice characteristics, which types of screening tests are used, and report diagnoses of glucose intolerance disorders.
Method
We will use the Clinical Practice Research Datalink (CPRD) Aurum dataset to discover patients with GD recorded in their medical record. CPRD Aurum contains deidentified patient data from GP practices in the UK that use the EMIS Web® software system.
Patient and practice characteristics and diabetes screening patterns will be summarised using descriptive statistics. We will describe coverage of diabetes testing by time since pregnancy according to variables including age, ethnicity, deprivation, and BMI at different time points. We will describe the types of test ordered and whether this was in line with the NICE guidelines at that time. Hazard ratios will be estimated with Cox regression models to examine the association between maternal characteristics and practice characteristics. In addition, survival analyses will be used to describe time since pregnancy to the last (most recent) test attended, and to diagnosis of diabetes or a glucose intolerance disorder.
Data will be analysed using STATA version 15.1 and R (latest release).
Source -
Utilisation, effectiveness, and safety of direct oral anticoagulants in patients with non-valvular atrial fibrillation and liver disease — Samy Suissa ...
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Utilisation, effectiveness, and safety of direct oral anticoagulants in patients with non-valvular atrial fibrillation and liver disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-28
Organisations:
Samy Suissa - Chief Investigator - McGill University
Antonios Douros - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Giada Sebastiani - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Ying Cui - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Ischaemic stroke, major bleeding, all-cause mortality, net clinical benefit.
Description: Technical Summary
Patients with liver disease were systematically excluded from the randomized trials assessing the efficacy and safety of direct oral anticoagulants (DOACs) for stroke prevention in non-valvular atrial fibrillation (NVAF). However, liver disease can modify the pharmacology of DOACs, and it can also increase both the thrombotic and the bleeding risk of NVAF patients, which complicates anticoagulant treatment in this vulnerable population. To date, observational studies assessing the effectiveness and safety of DOACs in NVAF patients with concomitant liver disease have been scarce. Moreover, they had methodological limitations rendering the interpretation of their results difficult. Of note, no studies have compared head-to-head apixaban versus rivaroxaban, the two DOACs most commonly used for stroke prevention in NVAF. Thus, the objective of this study will be to assess the utilisation, effectiveness, and safety of DOACs in NVAF patients with liver disease, while also comparing apixaban versus rivaroxaban in the same population. To this end, we will first describe the utilisation of DOACs in NVAF patients with liver disease between 2011 (the year DOACs were approved for stroke prevention in NVAF in the United Kingdom) and 2019 by characterising the groups of patients who initiate DOACs versus the therapeutic alternative vitamin K antagonists (VKAs), characterising the groups of patients who switch from VKAs to DOACs versus remaining on VKAs, and assessing long-term treatment persistence of DOACs versus VKAs. Then, we will use time-dependent Cox proportional hazards model to estimate confounder-adjusted hazard ratios and 95% confidence intervals of the association between the risk of ischaemic stroke, major bleeding, and all-cause mortality and current use of DOACs compared with current use of VKAs (or current use of apixaban compared with current use of rivaroxaban) in NVAF patients with liver disease. Moreover, we will estimate the net clinical benefit of DOACs versus VKAs (or apixaban versus rivaroxaban).
Source -
Ethnic Inequality in Diagnosis and Outcomes of Cancer — Tanimola Martins ...
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Ethnic Inequality in Diagnosis and Outcomes of Cancer
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-27
Organisations:
Tanimola Martins - Chief Investigator - University of Exeter
Tanimola Martins - Corresponding Applicant - University of Exeter
Gary Abel - Collaborator - University of Exeter
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Obioha Ukoumunne - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
 Ethnic differences in symptom profile
 Ethnic differences in time to diagnosis
 Ethnic differences in stage of cancer at diagnosis
 Ethnic differences in route to diagnosis (principally emergency presentations)
 Ethnic differences in 1 and 5-year survival ratesDescription: Technical Summary
This study aims to investigate ethnic inequalities in patients cancer journeys - from the first consultation in primary care to a definitive diagnosis, and eventual outcomes. We will use CPRD Aurum records (linked to registry data from the National Cancer Registration and Analysis Services (NCRAS), Hospital Episode Statistics (HES), Office for National Statistics (ONS) and Index of Multiple Deprivation (IMD) to examine ethnic differences in:
a) GP consultation rates before referral to secondary care for suspected cancer diagnosis
b) the profile symptoms presented in primary care before diagnosis
c) diagnostic interval - the interval between first primary care consultation and definitive diagnosis
d) the routes to diagnosis (RTD)
e) the staging at diagnosis and survival ratesParticipants will include patients diagnosed with 11 primary cancers since 2000, including those frequently diagnosed in ethnic minority groups (lung, breast, colorectal, prostate, stomach, oral, liver, ovarian, oesophageal, cervical, and myeloma). Chi-squared tests will be used to investigate ethnic differences in symptoms profile. Poisson regression models will be fitted to examine ethnic differences in consultation rates and diagnostic intervals. Logistic regression models will investigate ethnic differences in RTD and stage at diagnosis. Finally, net survival models will investigate ethnic variation in cancer survival. Analyses will be performed by cancer types.
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Cardiovascular comorbidity prevalence in males with haemophilia A — Alexander Michel ...
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Cardiovascular comorbidity prevalence in males with haemophilia A
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-07
Organisations:
Alexander Michel - Chief Investigator - Bayer AG
Alexander Michel - Corresponding Applicant - Bayer AG
Ceri Hirst - Collaborator - Bayer AG
Fang Xia - Collaborator - Bayer AG
Inga Bayh - Collaborator - Bayer AG
Marcela Rivera - Collaborator - Bayer AGOutcomes:
a.     Arterial hypertension
b. Diabetes mellitus (type I and II)
c. Hypercholesterinemia
d. Renal failure
e. Coronary heart disease
f. Myocardial infarction
g. Atrial fibrillation
h. Heart failure
i. VTE
j. TIA/ischemic stroke
k. COPD
l. Depression
m. Sleep apnea syndrome
n. HIV
o. Hepatitis C
p. BMI (in adults, <25 versus >25) highest value will be considered for individuals with several values available
q. Smoking status (never versus smoking at any time)
r. Overall mortality/cardiovascular mortalityDescription: Technical Summary
Today, with the advent of modern treatment modalities , life-expectancy of patients with hemophilia (PWH) has improved dramatically and thus older PWH are not only affected by the comorbidities of hemophilia (arthropathy, consequences of viral infections), but also by the comorbidities associated with aging. However, contemporary population-based data allowing a direct comparison of haemophilia patients with age-matched non-hemophilia patients regarding cardiovascular comorbidity and risk factor profile are currently limited, and the results are inconsistent.
The presently proposed study, using large population-based healthcare databases in the UK and the US, will allow such a direct comparison and thus generate more contextual data to describe the cardiovascular risk and risk factors in patients with haemophilia A. Primary outcomes will be the period prevalence of cardiovascular comorbidity (e.g. hypertension, diabetes mellitus, coronary heart disease, renal failure, atrial fibrillation and others) in the hemphilia A group compared to the non-hemophilia patients matched for categories of age, GP practice, year of cohort entry. As secondary outcomes overall mortality and cardiovascular mortality will be investigated.
Statistics will be descriptive and explorative in nature. Period prevalence will be calculated, defined as:
Proportion of the population with the specific outcome over the total study time period. Relative risk (prevalence ratio) for exposure group comparison including 95% confidence intervals, by dividing the period prevalence in the PWH cohort by the period prevalence in the comparison cohort (We will check if the available observation-time in the database for the hemophilia cohort and the non-hemophilia cohort is similar, if not, adjustments will be made).Stratifications into age-bands will be made. The following age-bands will be used: 0-30, 30-60 and >60 years of age.
Mortality rate calculated as incidence rate using person-time will be calculated as secondary analysis:
- Mortality using cardiovascular diagnosis 30 days before death as a proxy.
- Mortality rate ratio and 95% Confidence Interval for exposure group comparison will be calculated.
Source -
Association between levels of antibiotic prescribing for respiratory tract infections in primary care and adverse outcomes — Tricia McKeever ...
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Association between levels of antibiotic prescribing for respiratory tract infections in primary care and adverse outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-28
Organisations:
Tricia McKeever - Chief Investigator - University of Nottingham
Stephanie Evans - Corresponding Applicant - Public Health England
Emily Agnew - Collaborator - Public Health England
James Stimson - Collaborator - Public Health England
Julie Robotham - Collaborator - Public Health England
Puja Myles - Collaborator - CPRD
Simon Royal - Collaborator - University of Nottingham
Wei Shen Lim - Collaborator - Nottingham University HospitalsOutcomes:
Adverse events occurring within 30 days of the first RTI related GP consultation. Specifically: Hospitalisation with community-acquired pneumonia; Any hospital attendance; GP re-consultation for RTI-related illness, prescription of antibiotics
Description: Technical Summary
The main aim of this study is to quantify the level of antibiotic prescribing of general practices (GPs) below which adverse outcomes from respiratory tract infections (RTIs) occur. We will establish whether there exist groups with an increased risk of adverse events within which we would expect prescribing rates (against RTIs) to be higher than in the general population e.g. elderly patients or those with certain comorbidities. We will also explore how the type and doses of antibiotic prescribed by each practice are associated with prescribing rates and adverse events. Data on GP visits and hospitalisation for individuals with at least one consultation for an RTI-related illness will be extracted from the dataset. We will follow individuals that consulted a GP for an RTI-related illness for 30 days following their first visit and model how practice-level prescribing modifies the risk of adverse outcomes (hospitalisation for pneumonia, hospitalisation in general, recurrent GP visits for respiratory or lung conditions). The prescribing rate of a practice will be calculated for every practice and RTI season (July 01 Â June 30 of each calendar year) and will be the fraction of RTI consultations where an antibiotic was prescribed out of all RTI consultations. The numerator will be calculated first including only prescriptions at an initial GP visit and then including any prescriptions within 30 days of an initial consultation. Case-mix adjusted prescribing rates will be calculated using direct standardization to account for differences in the distribution of comorbidities among patients presenting with RTI to different practices (asthma, chronic respiratory, kidney, heart, liver, or neurological disease, diabetes or immunosuppression. In case of insufficient numbers per category, indirect standardization will be used. We will use binary logistic regression controlling for patient-level confounders of comorbidities, social status, smoking status, and age.
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A retrospective cohort study to assess whether urate lowering therapy improves outcomes in patients with hyperuricemia and/or gout with a history of heart failure — Alyshah Abdul Sultan ...
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A retrospective cohort study to assess whether urate lowering therapy improves outcomes in patients with hyperuricemia and/or gout with a history of heart failure
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-18
Organisations:
Alyshah Abdul Sultan - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Alyshah Abdul Sultan - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Fredrick Erlandsson - Collaborator - Astra Zeneca Inc - USA
Irena Brooks-Smith - Collaborator - Astra Zeneca Ltd - UK Headquarters
Johan Hoegstedt - Collaborator - Astra Zeneca Inc - USA
Jonatan Hedberg - Collaborator - Astra Zeneca Inc - USA
Karolina Andersson Sundell - Collaborator - Astra Zeneca R&D Molndal Sweden
Katarina Hedman - Collaborator - Astra Zeneca Ltd - UK Headquarters
Magnus Bjursell - Collaborator - Astra Zeneca Inc - USA
Michael Stokes - Collaborator - Evidera, Inc
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
The primary aim of this investigation is to assess the following outcomes: all-cause mortality, CV-related mortality, hospitalizations for HF, and composite measure of all-cause mortality or hospitalization for HF. We will also assess composite measure of CV-deaths and HF.
Description: Technical Summary
Verinurad is a urate transporter 1 (URAT-1) inhibitor that, in combination with a xanthine oxidase inhibitors (XOI), can lower serum uric acid (sUA) by 70-80%. The initial development program focused on gout, however, it is being repurposed for development in other indications. There is a strong association between elevated sUA and incidence of heart failure (HF), in particularly those with preserved ejection fraction (HFpEF). It remains unclear whether lowering sUA can improve outcomes in heart failure patients. Around 35% of patients with gout are prescribed urate lowering therapy (ULT). Therefore, the aim of this investigation is to conduct comparative effectiveness analyses examining health outcomes among patients with gout and a history of heart failure who initiate therapy with ULT versus those who do not.
Methods and analysis
We will include all patients ?18 years old with a recorded diagnosis of gout and/or elevated serum urate level (serum urate level >6 mg/dl) during April 1, 1997 to June 31, 2019 who also have a history of heart failure. To better ascertain comorbidities and hospitalisation episodes, only those with linked secondary care data will be included. The baseline characteristics, comorbidities, comedication use and patterns of sUA measurement will be summarised using descriptive statistics (e.g. test, chi-squared test). Finally, we will assess whether ULT is associated with improved health outcomes in patients with gout who have a history of heart failure, however, this analysis will only be carried out if there are sufficient number of outcomes and adequate recorded information on confounding factors.
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Prescription medications for cardiovascular disease and metabolic syndrome and risk of ovarian cancer in the Clinical Practice Research Datalink — Nicolas Wentzensen ...
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Prescription medications for cardiovascular disease and metabolic syndrome and risk of ovarian cancer in the Clinical Practice Research Datalink
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-02-28
Organisations:
Nicolas Wentzensen - Chief Investigator - National Cancer Institute ( NCI )
Megan Clarke - Corresponding Applicant - National Cancer Institute ( NCI )
Britton Trabert - Collaborator - National Cancer Institute ( NCI )
Kara Michels - Collaborator - National Cancer Institute ( NCI )
Marie Bradley - Collaborator - Food and Drug Administration - FDA
Ruth Pfeiffer - Collaborator - National Cancer Institute ( NCI )
Sarah Irvin - Collaborator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Collaborator - National Cancer Institute ( NCI )
Tamara Litwin - Collaborator - National Cancer Institute ( NCI )Outcomes:
·       Ovarian cancer
Description: Technical Summary
Ovarian cancer is the deadliest gynaecological cancer, with 7,284 cases and 4,128 deaths estimated in 2014. Obesity and related metabolic conditions such as insulin resistance, hypertension, and dyslipidaemia may be associated with certain types of ovarian cancer. Mechanisms underlying these associations may involve perturbations in several biological pathways, including sex steroid hormone, insulin and insulin-like growth factor (IGF-1), and pro-inflammatory cytokine (e.g., tumour necrosis factor alpha (TNF?) and interleukin-6 (IL-6)) signaling[9, 10]. Pharmacologic antagonism of these pathways may have unanticipated beneficial effects in relation to ovarian carcinogenesis. This hypothesis has led to growing interest in evaluating (i.e., ÂrepositioningÂ) these medications, with the goal of identifying novel molecular targets for pharmacological interventions. We propose to investigate the associations of common medications prescribed to treat metabolic conditions and cardiovascular disease, specifically: statins, metformin, non-selective beta-blockers, and cardiac glycosides, with risk of ovarian cancer in a large, longitudinal primary care database known for highly accurate and complete diagnostic and drug prescribing data.
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A Contemporary Community Heart Failure Service — Imperial College Healthcare NHS Trust...
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A Contemporary Community Heart Failure Service
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Heart Failure. Academic
Source -
Historical cohort study to investigate primary care diabetes provision among groups with different protected characteristics and from different health exclusion groups — Imperial College Health Partners...
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Historical cohort study to investigate primary care diabetes provision among groups with different protected characteristics and from different health exclusion groups
Legal basis:De-identified Data Access Request –
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Data Access Request –. Commercial
Source -
Retrospective Study: Real world data evaluation of prescribing practices and safety data for Metformin Prophylaxis in patients prescribed anti-psychotic medication — Imperial College Health Partners...
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Retrospective Study: Real world data evaluation of prescribing practices and safety data for Metformin Prophylaxis in patients prescribed anti-psychotic medication
Legal basis:Retrospective Study:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: Metformin. Comercial
Source -
To assess the maternal vaccination uptake in the Northwest (NWL) London population through use of the Whole System Integrated Care database (WSIC) — Imperial College Health Partners...
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To assess the maternal vaccination uptake in the Northwest (NWL) London population through use of the Whole System Integrated Care database (WSIC)
Legal basis:De-identified Evaluation Request
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-20
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: De-identified Evaluation Request. Commercial
Source -
Retrospective Study: Psychological factors predicting clinical outcome following Bariatric Surgery — Imperial College Healthcare NHS Trust...
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Retrospective Study: Psychological factors predicting clinical outcome following Bariatric Surgery
Legal basis:Retrospective Study:
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Feb-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Bariatric Surgery. Academic
Source
2020 - 01
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Violence-related incidents and underlying vulnerability —
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Violence-related incidents and underlying vulnerability
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: Professor Susan McVie, University of Edinburgh, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why: Our research will focus on four main areas:
To understand how underlying aspects of vulnerability (drug use, alcohol and mental health conditions) are related to violence-related incidents, and how this varies across different socio-demographic groups.To explore the patterns of demand on public services caused by violence-related incidents.
To investigate the longer term outcome of violence-related incidents, including further examples of vulnerability and risk of death.
To examine temporal and spatial patterns of demand for ambulance call-outs to violence-related incidents
Despite a remarkable reduction in recent years, violent crime is still a key policy priority in Scotland. Emergency services deal with high volumes of violent incidents and an increasing number of calls involve some aspect of underlying vulnerability. Policy makers are keen to understand more about how aspects of vulnerability impact on violent crime, especially as this is a primary driver for policies like the âpublic health approach to reducing violenceâ and âadverse childhood experiencesâ informed approaches to policing.
Our proposed research seeks to address questions surrounding violence and underlying vulnerability, and how these factors contribute to the patterns of demand on public services in Scotland. We plan to achieve this by linking ambulance call-outs, hospital admissions, and deaths data which identify violence related incidents with data on drug misuse, alcohol and mental health conditions.
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Wage and employment dynamics in Britain — unknown...
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Wage and employment dynamics in Britain
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is working with the University of the West of England (UWE), University College London (UCL), City, University of London and the National Institute of Economic and Social Research (NIESR) on Wage and Employment Dynamics (WED), a data linkage project which aims to provide important new insights into the dynamics of earnings and employment in Britain.
This project is expected to increase understanding of how peopleâs wages progress through their career, factoring in key characteristics such as gender and ethnicity, as well as the particular dynamics of low-pay labour markets.
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Assessing the impact of benefit sanctions on health — unknown...
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Assessing the impact of benefit sanctions on health
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
People who claim some benefits, such as Jobseeker's Allowance (JSA) have conditions placed on them which they are required to meet in order to receive benefit. With JSA, for example, claimants must sign on at the Jobcentre Plus office regularly and show that they have taken certain steps to find work. If they fail to meet these conditions, they can be sanctioned, i.e. their benefits are stopped for a period. There have always been conditions on unemployment benefits but they have increased in recent years, with the number of sanctions and maximum length rising. The introduction of Universal Credit has seen conditions extended to those in work as well.
Sanctions are meant to encourage people to return to work as soon as they can. This can be good for public finances as it keeps claims down, good for the economy as it keeps labour supply up and, arguably at least, good for claimants since unemployment tends to be bad for our health. However, critics argue that sanctions may have unintended side-effects: harming claimant health, increasing risks of homelessness, or putting stress on families which can harm children. Health effects may arise from having less money to spend on food or heating, but also from the psychological stresses of trying to cope without income. These unintended impacts could lead in turn to greater expenditure on public services, off-setting savings from reduced benefit claims.
This research seeks to examine whether benefit sanctions lead to claimants having worse physical or mental health, or making greater use of health services in Scotland. It also seeks to add to our knowledge on whether sanctions encourage claimants to return to employment more quickly. It will be innovative in using a database of individuals' benefits, employment and health histories constructed from administrative records for the Scottish population which have not previously been linked.
Specifically, the research will aim to:
Identify the extent to which imposition of sanctions on Job Seekerâs Allowance and Employment and Support Allowance claimants tends to lead to worse health outcomes or greater use of health services. Identify variations between groups in health impacts of sanctions, for example, by age, gender, disability, pre-existing health condition or labour market area, as well as welfare benefit category (JSA or ESA). Identify the extent to which the imposition of sanctions on JSA and ESA claimants leads to greater movement off benefits or better employment outcomes. Identify whether any health impacts of sanctions are moderated by employment outcomes. Make clear recommendations for policy reform on the basis of this evidence and contribute to broader debates about the nature of conditionality in the welfare system.
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Health and employment retention —
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Health and employment retention
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: Dr Serena Pattaro, University of Glasgow, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why: We aim to address the following research questions:
What are the factors associated with remaining in employment following the experience or onset of physical/mental health problems? How do they vary by individual characteristics such as age, level of qualifications, occupation or industry, household situation or nature of physical/mental health problem? How do retention rates vary by labour market context (e.g. local unemployment rate)? What institutional factors â for example, variations in the level or nature of local health services â make a difference to retention rates, and for which groups? For those who lose employment, what factors are associated with movement into the long-term sick (inactive) category rather unemployment?This research aims to investigate the relationship between both physical and mental health conditions and employment retention in Scotland. It does this using an innovative combination of Census data linked to prescribing information, hospital admission records and data from the benefit system.
There is a broad policy concern with raising employment rates for those with long-term illness or disability and reducing the number of people who lose employment following the onset of a health problem. Our research has been developed in close collaboration with colleagues at Scottish Government. Our research aims to provide an initial knowledge base for a complex analytics framework and seeksto identify people most at risk of dropping out of employment as a result of a physical and/or mental health condition, in order that appropriate health interventions can be targeted to them.
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Growing Up in England: Linking 2011 Census and educational attainment data for children — unknown...
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Growing Up in England: Linking 2011 Census and educational attainment data for children
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK, the Office for National Statistics (ONS) and the Department for Education (DfE) are working together to make better use of existing data about children and young people in England.
The Growing up in England (GUIE) dataset will enable a more comprehensive understanding of how factors such as family background, school type and geography shape outcomes. This will allow researchers to shine light on what does and doesnât work in supporting children and young people to thrive and give policymakers valuable evidence for developing services that work better for all.
The datasetONS has linked 2011 Census records to an attainment dataset from DfE named the Feasibility All Education Dataset for England (AEDE) to create a useful resource for research. The final longitudinal dataset covers the academic years 2001/02 to 2014/15and includes data from all local-authority maintained schools in England. Around seven million records have been matched, producing a significant sample size for analysis.
What is the potential of this newly linked data?The Childrenâs Commissioner for England's 2017 review of childhood vulnerability identified an evidence gap in information about the lives of vulnerable children. The GUIE dataset can help address this gap by enabling researchers to investigate how a child's circumstances and characteristics, and those of others in their household, influence educational attainment. No other data source has this level of insight on children who are vulnerable or of concern by virtue of their circumstances; for example, children caring for others, children with a disability or ill-health and children from workless families.
The creation of this linked dataset will enable a breadth of new research questions to be answered; questions that are much more difficult to answer using traditional data collection methods such as surveys. Children are a vulnerable group, and capturing useful data about their lives can be tricky.
Research questions that the GUIE dataset could help to answer include:
Is there a relationship between personal/familial characteristics and educational attainment? What are the educational outcomes for Roma, Gypsy and Traveler children and young people? What are the underlying drivers of geographical differences in educational attainment?The feasibility of the GUIE project was confirmed by successfully linking 2011 Census data and an extract of the Feasibility AEDE dataset. This Proof of Concept (PoC) study was conducted by the ONS Centre for Equalities and Inclusion to test the use of the data for providing insights on personal characteristics, educational attainment, household characteristics, vulnerable groups and geography. You can see the full report detailing the findings, published July 2020, on the ONS website.
The Growing Up in England dataset will be made available to external researchers via the ONS Secure Research Service. Researchers will need to be approved and submit a successful application to access the data. Sign up to our mailing list to be first to hear when the data becomes available.
This project is funded by ONS via its core grant from the Economic & Social Research Council (ESRC) as an ADR UK partner.
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Drug related deaths and contact with emergency services —
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Drug related deaths and contact with emergency services
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: Professor Susan McVie, University of Edinburgh and Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why: The project aims to answer questions including:
What proportions of people who experienced a drug-related death had contact with a) ambulance services and b) police within the year leading up to death? What type of contact do people experiencing drug-related deaths tend to have with emergency services in the year prior to death (e.g., type of complaint to SAS, incident code with Police)? What are the common of sequences of contact with services in the 6 month period leading up to drug-related deaths?This project aims to link the National Drug-Related Deaths Database (NDRDD) to information on ambulance call-outs and police incidents to gain a broader understanding of the patterns of contact with services (in particular the emergency services) prior to drug-related deaths in Scotland.
Drug-related deaths in Scotland are at the highest level (1,187 in 2018) since records began (224 in 1996); the highest rate of any country in the European Union. This increase has been labelled a âcrisisâ and an âemergencyâ, and in September 2019 a government taskforce devoted to tackle the rising number of drug-related dealths met for the first time.
Source -
Understanding Children's Lives and Outcomes in Scotland — unknown...
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Understanding Children's Lives and Outcomes in Scotland
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
Scotland has high quality data about children, though it is currently not organised in a way that would allow research on a range of outcomes and how they vary across Scottish society. The 'Understanding Children's Outcomes' project, led by ADR Scotland, aims to change that.
The datasetADR Scotland is working to bring together a range of data on children.
This will include: pupil census data for Scotland, Scottish Government data on looked after children, childrenâs health, births and deaths, the 2001/2011 national census, attendance, absence and exclusion from school, child protection, secure care for children, exam qualifications, school leaver destinations, and child wellbeing.
The project aims to provide information about the data and enable access with the potential for it to be linked together.
What is the potential of this newly linked data?This data will allow researchers to paint a picture of academic achievement, health, economic activity and wellbeing for children and young people in Scotland. This will tie in with the national ambitions for people in Scotland, which are captured in the National Performance Framework, namely that children grow up loved, safe and protected so they can reach their full potential.
Having Scotland-wide datasets brought together will provide a set of outcomes for children, and brings in data on inequalities, to help researchers build a more thorough understanding of the experience of children in the country. Decision makers can then be better informed on how best to meet Scotland's ambitions for children.
Exemplar projects underway to demonstrate the use of this data include:
Exploring context, factors and approaches to educational exclusions and absence Growing up in kinship care Project details Project lead: Roger Halliday, Chief Statistician, Scottish Government Funded value: £489,844 Duration: September 2019 â March 2022
Source -
ECHILD: Linking childrenâs health and education data for England — unknown...
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ECHILD: Linking childrenâs health and education data for England
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding the creation of a research-ready database linking health, education and social care data for all children in England for the first time.
ECHILD stands for Education and Child Health Insights from Linked Data. The study involves the linking of around 14 million childrenâs records, which will be used to better understand how education affects childrenâs health and how health affects childrenâs education.
The ECHILD project is led by University College London in collaboration with the London School of Hygiene & Tropical Medicine and the Institute for Fiscal Studies, in partnership with NHS Digital and the Department for Education, working with the Office for National Statistics (ONS).
The dataThe ECHILD Database will bring together information about health, education and social care for all children in England for the first time. The project will link two key data sources:
The National Pupil Database (NPD) â which holds a wide range of information about students who attend schools and colleges in England. Hospital Episode Statistics (HES) â which includes information on hospital admissions, A&E attendances and outpatient appointments in NHS hospitals in England.The ECHILD Database is de-identified: this means it does not contain any information that identifies an individual. For example, it does not include names, addresses, dates of birth, pupil or NHS numbers.
How is the ECHILD study using this newly linked data?The ECHILD team are carrying out strategic research, based on a pilot linked NPD-HES dataset of two million children, to validate linkage and other aspects of data quality. This will produce resources and metadata for wider use of the ECHILD Database. The ECHILD project is also generating policy-relevant exemplar research.
The ECHILD Database will first be used to understand how disruptions to services during the national lockdown affected childrenâs health and education. The work will focus on children who require extra support, as they may have been most affected by the changes to services. This includes children with chronic physical and mental health conditions, receiving special educational needs support or who are in care. The results of this work will help policymakers and services make plans as we all learn to live with Covid-19.
What is the potential of this newly linked data?The ECHILD Database will facilitate research to improve policymaking for childrenâs health, education and wellbeing across a range of health and social science disciplines. For example, the ECHILD Database could help to answer questions such as:
How can we improve health and education for children with chronic physical or mental health conditions in England? How can we better understand the health-related drivers of educational outcomes in England? How can we improve the quality and equity of health and education provision in England?The ECHILD Database will be made available to external researchers via the ONS Secure Research Service down the line. Researchers will need to be approved and submit a successful application to access the data. Check back here for more information about accessing the linked data as an approved researcher soon.
Engaging the publicThe ECHILD team is working with patient, pupil, parent and public engagement groups to understand different views on the use of linked health, education and social care data for research. This includes getting valuable feedback on research plans for the ECHILD project. So far, the team has worked with the National Childrenâs Bureau Young Research Advisors; the National Childrenâs Bureau Families Research Advisory Group; and the Council for Disabled Children FLARE. You can find out more about this work, and what the team learned, on the ECHILD website.
In August 2021, a report highlighting key messages from government and third sector stakeholders on the potential of the ECHILD Database was also published. Read the report.
Project detailsNHS Digital is being funded to link and curate the ECHILD Database:
Principal investigator: Garry Coleman Funding amount: £368,572 Duration: December 2019 to March 2022The UCL research team is being funded to validate linkage and other aspects of data quality, develop ECHILD Database documentation and governance with data controllers, conduct research to demonstrate the value of the ECHILD Database for policy and lead a programme of public engagement:
Principal investigator: Professor Ruth Gilbert, University College London Funding amount: £334,509.28 Duration: May 2020 â March 2022This project is funded via the ADR UK Strategic Hub Fund, a dedicated fund for commissioning research using newly linked administrative data, in consultation with the former Research Commissioning Board (RCB). Details of the funding grant awarded for this project can also be found on the UK Research & Innovation (UKRI) Gateway to Research.
The National Institute for Health Research (NIHR) is also funding the ECHILD project team to examine the impact of the Covid-19 pandemic and lockdown on vulnerable groups of children.
You can find out more about the project on the ECHILD website.
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Illegal drug consignments — unknown...
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Illegal drug consignments
Where: unstated
When: 2020-1-27
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: In future this research will aim to explore:
Are drug parcel seizures and controlled parcel deliveries associated with lower prevalence of recent drug use, medical admissions and deaths among the drug using population within local communities? Can intercepted packages data be used in conjunction with Police Scotland data and Scottish Neighbourhood Statistics to improve estimation of the level of illegal drug use in an area?This project aims to examine the effects of disruptions to the illegal drugs supply on drugs-related health outcomes in Scottish communities, focusing on the impacts of law enforcement tactics used to counter the postal delivery of drugs.
To date, analysis has focused on the National Crime Agency 'Controlled Deliveries' data: exploring the consignment sizes of different drugs packages identified by the UK Border Agency being intended to be delivered into Scotland in the post between April 2011-Jaunary 2016 to assess whether these packages are most likely to be for personal use, non-commertically related (or 'social') supply or for commertically-motivated resale.
This question is particularly pressing given the rise of online cryptomarkets and the challenges these pose for law enforcement agencies in addressing the supply of illegal drugs in Scotland. Further understanding the flows of drugs through the post could provide a better estimate of the overall effects of programmes intended to reduce problem drug use in Scotland by improving the accuracy of the necessary outcome measure.
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An observational study of comorbidities and clinical events among patients with Progressive Supranuclear Palsy (PSP) — Demetris Pillas ...
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An observational study of comorbidities and clinical events among patients with Progressive Supranuclear Palsy (PSP)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-16
Organisations:
Demetris Pillas - Chief Investigator - UCB Pharma Ltd
Demetris Pillas - Corresponding Applicant - UCB Pharma Ltd
Adam Jedrzejczyk - Collaborator - UCB Pharma Ltd
Anna Scowcroft - Collaborator - UCB Pharma LtdOutcomes:
Primary Outcomes
ÂFalls; Fall-related injuries; Falls leading to hospitalization; Unsteady gait / axial rigidity / ataxia; Mobility problems; Impaired eye movements; Swallowing problems; Speech problems; Urinary Incontinence; Erectile Dysfunction; Cognitive impairment/ dementia; Nursing care/ homebound/ bedbound; Residential Care; Walking Aids; Wheelchair Use; Palliative Care; Feeding Tube; Pneumonia (including Aspiration Pneumonia); Mortality, All cause; Life Expectancy; Cause of death; Suicide (including ideation and self harm); Myocardial Infarction (MI); Stroke/ Transient Ischaemic Attack (TIA); Chronic Obstructive Pulmonary Disease (COPD); Diabetes; Coronary Heart Disease; Kidney failure; Liver failure; Cancer; Hypersensitivity and anaphylaxis; CNS inflammation and demyelinisation; Mood disorders (including depression, which should also be reported separately); Sleep disordersÂSecondary Outcomes
ÂPatients on medications for PSP-related symptomsÂDescription: Technical Summary
Background and Purpose of the Study
It is of scientific interest to understand the comorbidities and background rates of a number of clinical events that are known to entail sequelae of PSP within a population of PSP patients.Overall Study Aim
To define a cohort of patients with diagnosed PSP and describe the comorbidities, background rate of events, and mortality rates within the cohort, and compare these to those of non-PSP patients.Study Data / Design
This is a retrospective observational study, using data from the Clinical Practice Research Datalink (CPRD) supplemented with linkage data from Hospital Episode Statistics (HES) and mortality data from the Office of National Statistics (ONS).Data Analysis
Part of the data analysis will be descriptive in nature: Patient characteristics will be summarized, and person-time incidence rates will be calculated for the clinical events of interest for each year following PSP diagnosis. Time from diagnosis to onset of clinical events will also be calculated. Additional statistical analysis will focus on evaluating the differences in risk (of experiencing an event, of mortality, etc), between the PSP vs non-PSP patient groups.
Source - and 27 more projects — click to show
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Oral anticoagulants and incidence of dementia in patients with non-valvular atrial fibrillation — Samy Suissa ...
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Oral anticoagulants and incidence of dementia in patients with non-valvular atrial fibrillation
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Alvi Rahman - Collaborator - McGill University
Erica Moodie - Collaborator - McGill University
James Brophy - Collaborator - McGill University
Jason Guertin - Collaborator - Université Laval
Jean-Francois Boivin - Collaborator - McGill University
Madeleine Durand - Collaborator - Centre Hospitalier de l'Universite de Montreal
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
We will identify all patients within our cohort with a first-time read code for dementia recorded any time after cohort entry. The diagnostic codes for dementia have been previously validated in the CPRD.
Description: Technical Summary
Oral anticoagulation is essential in the management of atrial fibrillation (AF) to prevent the physical disability and mortality associated with stroke occurrence but may also play a role in maintaining cognitive functions. Indeed, patients with AF have an increased risk of dementia compared to the general population. This association has been shown not only with vascular dementia but also with other types of dementia including Alzheimer's disease. In addition to the easily explainable link between AF and vascular dementia in relation to the occurrence of strokes, the association with other types of dementia may be related to repeated microembolisms, but other mechanisms may also be involved. However, few studies have assessed the potential preventive role of oral anticoagulants on the risk of dementia in patients with AF. Thus, we will conduct a population-based cohort study to assess whether the use of oral anticoagulants is associated with the incidence of dementia among patients with non-valvular atrial fibrillation. We will form a cohort of all patients aged 50 years or older newly diagnosed with non-valvular AF between 1988 and 2017. Exposure to oral anticoagulants will be modelled as a time-dependent variable. We will use Cox proportional hazards models to estimate hazard ratios with 95% confidence intervals of dementia associated with use of oral anticoagulants compared with no use. In secondary analyses, we will assess whether this risk varies with cumulative duration of use and with time between AF and oral anticoagulant initiation. Several sensitivity analyses will be performed to assess the robustness of our results.
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Use of Hydrochlorothiazide and the Risk of Melanoma and Non-Melanoma Skin Cancer: A Population-Based Cohort Study — Samy Suissa ...
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Use of Hydrochlorothiazide and the Risk of Melanoma and Non-Melanoma Skin Cancer: A Population-Based Cohort Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-23
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Anton Pottegard - Collaborator - University Of Southern Denmark
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Julie Rouette - Collaborator - McGill University
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Laurent Azoulay - Collaborator - McGill UniversityOutcomes:
We will identify all incident melanoma and non-melanoma skin cancer events recorded in the CPRD (identified based on Read codes; see Table A1 in Appendix). Melanoma skin cancer includes 4 main types: superficial spreading melanoma, nodular melanoma, lentigo maligna melanoma, and acral lentiginous melanoma. Non-melanoma skin cancer includes basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Diagnoses of melanoma skin cancer in the CPRD have been previously validated, with a sensitivity of 77% for melanomas when compared with diagnoses in the UK National Cancer Data Repository.1,2 The CPRD has also been shown to capture more non-melanoma cases that are missed by other data sources.
Description: Technical Summary
Antihypertensive drugs are one of the most commonly prescribed drugs worldwide, with thiazide diuretics accounting for nearly 30% of these prescriptions. Hydrochlorothiazide is a type of thiazide diuretics with photosensitizing properties. Recently, some observational studies have reported associations with melanoma and non-melanoma skin cancer. This possible association however warrants further investigation. This is particularly important given that skin cancer has the highest incidence among all cancers. To address this question, we will assemble a cohort of approximately 200,000 patients newly treated with either hydrochlorothiazide or other thiazide diuretics between January 1, 1988 and March 31, 2018, with follow-up until March 31, 2019. Cox proportional hazard models will be used to estimate hazard ratios with 95% confidence intervals of melanoma and non-melanoma skin cancer comparing hydrochlorothiazide with other thiazide diuretics using propensity score matching and fine stratification. Secondary analyses will assess whether the risk of those cancers varies according to age, sex, and immunosuppressive status.
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Impact of Covid-19 on primary care contact, referrals to follow-up care and patient outcomes after emergency department and primary care presentations for self-harm: cohort study using linked hospital and primary care health records — Darren Ashcroft ...
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Impact of Covid-19 on primary care contact, referrals to follow-up care and patient outcomes after emergency department and primary care presentations for self-harm: cohort study using linked hospital and primary care health records
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-30
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Sarah Steeg - Corresponding Applicant - University of Manchester
Brian McMillan - Collaborator - University of Manchester
Emma Nielsen - Collaborator - University of Nottingham
Laszlo Trefan - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Pearl Mok - Collaborator - University of Manchester
Roger Webb - Collaborator - University of ManchesterOutcomes:
GP contacts (including face-to-face and telephone consultations), referrals to mental health services, prescriptions for psychotropic medication, psychiatric outpatient appointments attended, repeat self-harm, suicide, external-cause mortality, all-cause mortality.
Description: Technical Summary
Monthly incidence and event rates of primary care and ED-presenting self-harm and likelihood of GP consultation and the type of care (including referral to mental health services and prescription for psychotropic medication) will be examined, comparing the March to August period in 2010-2019 to the same period in 2020. Predicted values (based on the antecedent period) will be estimated and compared to observed values during the Covid-19 period, with the values compared using a ratio measure (and its 95% CI). The modelling will be conducted using a negative binomial/Poisson type approach. We will examine differences between groups of patients, specifically age group, gender, ethnic group, COVID-19 shielding status, mental illness and area-level social deprivation.
Risks of the following adverse outcomes following primary care-recorded will be compared between the March to August period in 2010-2019 and the same period in 2020: repeat self-harm (presentations to ED or primary care), suicide, external-cause mortality and all-cause mortality. Cox regression models will be used to estimate hazard ratios for repeat self-harm, suicide, external cause mortality and all-cause mortality.
We will also examine clinical management and risks of adverse outcomes separately for ED-presenting self-harm. Using HES A&E and HES APC data, a cohort of people presenting to ED with self-harm, comparing the March to August period in 2010-2019 to the same period in 2020. This cohort will be linked to records in HES OP, CPRD GOLD and Aurum, IMD and ONS Death Registrations. We will only include patient records that are considered to be of an acceptable quality for research. When using GOLD data, we will only include patients who have been registered with a general practice deemed to be up to standard with respect to continuity and standard data completeness criteria.
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Changes in serum creatinine values during and after pregnancy in a cohort of women with or without pre-existing chronic kidney disease — Susan Jick ...
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Changes in serum creatinine values during and after pregnancy in a cohort of women with or without pre-existing chronic kidney disease
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-23
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Carole Marxer - Corresponding Applicant - University Hospital Basel
Christoph Meier - Collaborator - University of Basel
Julia Spoendlin - Collaborator - University of Basel
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rishi Desai - Collaborator - Harvard Medical SchoolOutcomes:
Key variables (descriptive study):
Delivery, last menstrual period (LMP, will be estimated and validated within the scope of this project), serum creatinine (SCr) measurements recorded during pregnancy and until one year after pregnancy; chronic glomerulonephritis; cystic kidney disease; haemodialysis; kidney transplantation; miscellaneous other renal diseases; hypertension; gestational hypertension; diabetes mellitus; gestational diabetes; pre-eclampsiaDescription: Technical Summary
CKD is characterized by impaired renal function and occurs in up to 3.3% of women of childbearing age. Healthy kidneys increase the filtration rate in reaction to physiological changes during pregnancy. Impaired kidneys may not sufficiently adapt to physiological changes during pregnancy, and there is a concern that pregnancy may accelerate permanent loss of renal function, especially in women with advanced kidney disease. However, evidence on changes in kidney function during and after pregnancy in women with and without CKD is sparse and mostly outdated.
We will conduct a descriptive study in a cohort of pregnant women with or without pre-existing CKD. We will identify pregnant women who delivered a singleton live-birth between 2000 and 2018. We will use the date of delivery and estimate the date of the last menstrual period (LMP) (and we will validate these dates using «Hospital Episode Statistics» data) to define the start and end of the pregnancy. In the study population, we will include all women with a recorded serum creatinine value (SCr) recorded between one year before the LMP and the end of trimester 1, and we will categorize them into one of four groups based on the mean estimated glomerular filtration rate (eGFR [ml/min/1.73m2]): 1) no CKD (eGFR ?90), 2) mild CKD (eGFR <90 and ?60), 3) moderate CKD (eGFR <60 and ?30), 4) severe CKD (eGFR <30). We will compare demographics and comorbidities between CKD severity groups and evaluate changes in SCr measurements during and after pregnancy in all four groups separately (excluding women without any follow up SCr measurement after trimester 1). Our results will support health professionals in decisions regarding which women need to be screened for CKD early in pregnancy, and which women with pre-existing CKD need to be monitored closely during and after pregnancy.
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Sodium-glucose transport protein 2 inhibitors and the risk of early breast cancer — Samy Suissa ...
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Sodium-glucose transport protein 2 inhibitors and the risk of early breast cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-06
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Melanie Suissa - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Stephanie Wong - Collaborator - McGill UniversityOutcomes:
The primary outcome of interest is a diagnosis of breast cancer, as determined by pre-specified CPRD Read Codes (listed in Appendix 2).
Description: Technical Summary
Current guidelines recommend sodium-glucose transport protein 2 (SGLT-2) inhibitors as second line therapy for patients with type 2 diabetes. SGLT-2 inhibitors act on the kidney to inhibit the sodium-glucose protein 2, thereby allowing the excretion of glucose in the urine (glycosuria) and the lowering of plasma glucose levels. However, the US Food and Drug Administration and the European Medicines Agency have raised concerns that certain SGLT-2 inhibitors, such as dapagliflozin, have been associated with early breast cancer events in premarketing trials. To date, however, no observational studies have been conducted to assess this possible increased risk in the real-world setting. Thus, to address this concern, we will conduct a large population-based cohort study to assess whether SGLT-2 inhibitors are associated with an increased risk of early breast cancer. The study population will consist of women over 40 years of age newly treated with SGLT-2 inhibitors or dipeptidyl peptidase 4 (DPP-4) inhibitors. Each patient will be followed until a first diagnosis of breast cancer, death from any cause, end of registration with the general practice, or end of study (January 31, 2019). We will use propensity score fine stratification to minimize potential confounding, and Cox proportional hazard models will be used to estimate the hazard ratios (with 95% confidence intervals [CI]) of breast cancer comparing SGLT-2 inhibitors users and DPP-4 inhibitors users. This large cohort study will provide the necessary information on the risks and benefits of SGLT-2 inhibitors.
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Mapping the risk of post-diagnosis infections in patients with multiple sclerosis in the UK population — Romin Pajouheshnia ...
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Mapping the risk of post-diagnosis infections in patients with multiple sclerosis in the UK population
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-17
Organisations:
Romin Pajouheshnia - Chief Investigator - Utrecht University
Romin Pajouheshnia - Corresponding Applicant - Utrecht University
Bernard Uitdehaag - Collaborator - VU Medical Centre
Hubert Leufkens - Collaborator - Utrecht University
Kyra Klijmeij - Collaborator - Utrecht University
Marloes Bazelier - Collaborator - Utrecht University
Melissa Leung - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht UniversityOutcomes:
Occurrence of infections of the four major types: urinary tract infection, infection of the pulmonary system, infection of the skin and subcutaneous tissue, and infection of the gastrointestinal system.
Description: Technical Summary
The aim is to describe the pattern and predictors of infections over the past 15 years in MS patients. A dynamic cohort of MS patients will be studied between January 2003 up until December 2019, who are at least 20 years old and free from malignancy at the moment of recorded diagnosis. In addition, two control groups will be studied with the same age/comorbidity eligibility criteria as above: i) patients with a diagnosis of rheumatoid arthritis (RA) and ii) a random sample of patients from the general population. The control groups will be matched to the MS cohort on age and sex. We will present annual incidence rates of episodes of infection in the MS cohort, and stratify on sex, age group (20-29 years, 30-39, 40-49, 50-59, and 60 and over), and incident/prevalent MS cases. We will perform a regression analysis on the incidence rate of infections during the year before and the years after recorded MS diagnosis for incident cases of MS during the study period. This will be compared to the incidence rates of infection in the two, matched control cohorts. We will also investigate whether associations exist between certain patient characteristics and risk of infection in MS patients. Data on covariates and outcomes are needed: the covariates are various patient characteristics assessed at the time of recorded diagnosis, including current and history of prescribed medicines, and the primary outcome is the incidence rate of episodes of infection per year of follow-up time. To find predictive factors of infection, multivariable analyses will be performed in a Poisson model with the candidate predictor variables as the independent variables and annual incidence rate of infection as the dependent variable. The effect size of each predictive variable will be calculated from its coefficient in the model.
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Prevalence, Treatment Pathway and Patient Outcomes of Primary Hypercholesterolaemia and Dyslipidaemia in England: The 4Ps Study — Adrian Paul J. Rabe ...
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Prevalence, Treatment Pathway and Patient Outcomes of Primary Hypercholesterolaemia and Dyslipidaemia in England: The 4Ps Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-27
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
Epidemiologic experience (annual incidence of PH and MD, period prevalence of PH and MD, mean annual prevalence of PH and MD), demographic characteristics and clinical profile (age, sex, blood pressure on inclusion, low density lipoprotein (LDL) level, total cholesterol level, prevalence of co-morbidities including cardiovascular disease, familial hypercholesterolaemia, diabetes, chronic kidney disease), clinical outcomes (incidence of myocardial infarction, unstable angina, stable angina, stroke, transient ischaemic attack, cardiovascular events in aggregate), healthcare resource use (inpatient admissions, outpatient appointments, A&E attendances, GP appointments and associated tariffs)
Description: Technical Summary
Primary hypercholesterolaemia (PH) and mixed dyslipidaemia (MD) portend a higher risk of cardiovascular events due to the thrombogenic milieu afforded by increased production and dysfunctional metabolism of cholesterol and other lipids.
The treatment of PH and MD involves administration of various medications, including statins, ezetimibe, PCSK9 inhibitors, weight control, and lifestyle modification, based on clinical practice guidelines. However, it is important to understand how these medications and treatments have been implemented in England. Additionally, it would be important to understand the changes in the epidemiology of PH and MD in England, the health outcomes PH and MD patients experience, and how much healthcare resources were expended in the care of patients with PH and MD in primary and secondary care.
In order to answer these questions, we intend to perform a study on the CPRD-HES linked data on patients diagnosed to have PH and MD. Through this, we can establish a trend in the prevalence and incidence of PH and MD, then determine their risk factor profile and demographic characteristics. We would then track patient records forwards to determine receipt of various medications used to treat PH and MD. Finally, we would like to determine the incidence of cardiovascular outcomes in that cohort, as well as the healthcare resource use in inpatient, outpatient, A&E and GP care.
Through our study, we hope to gain a clearer understanding of PH and MD in England, what treatment pathways patients with PH and MD undergo, and what outcomes they experience.
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GARFIELD-AF in Primary care  Optimising prediction of mortality, stroke and major bleeding for patients with atrial fibrillation using routinely collected primary care electronic health records — David Fitzmaurice ...
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GARFIELD-AF in Primary care  Optimising prediction of mortality, stroke and major bleeding for patients with atrial fibrillation using routinely collected primary care electronic health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-08
Organisations:
David Fitzmaurice - Chief Investigator - University of Warwick
Patricia Apenteng - Corresponding Applicant - University of Warwick
David Prieto-Merino - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Diane Eaton - Collaborator - Anticoagulation UK
Karen Pieper - Collaborator - Thrombosis Research Institute
Keith Fox - Collaborator - University of Edinburgh
Rishi Caleyachetty - Collaborator - University of Warwick
Siew Wan Hee - Collaborator - University of Warwick
Trudie Lobban - Collaborator - Atrial Fibrillation AssociationOutcomes:
All-cause mortality, Stroke and Systemic embolism, major Bleeding
Description: Technical Summary
Atrial fibrillation (AF), the most common clinically significant arrhythmia in the adult population, increases the risk of stroke five-fold. AF related strokes are more severe with increased mortality and disability than strokes in people without AF. Anticoagulation therapy can reduce up to two-thirds of this stroke risk and reduce mortality by up to 25%. However, anticoagulation increases the risk of bleeding. Risk scores are therefore used to assess stroke and bleeding risk to guide decisions on anticoagulation, and current NICE guidelines recommend the use of CHA2DS2VASc tool to assess stroke risk and HAS-BLED to assess bleeding risk.
The GARFIELD-AF tool is a novel risk prediction tool that simultaneously assesses a patients risk of mortality, AF-related stroke and major bleeding. It was developed using data from 39,898 patients in the global GARFIELD-AF registry and predicts mortality, stroke and bleeding better than the existing tools. The GARFIELD-AF tool offers a more accurate and integrated method to facilitate decisions on anticoagulation of patients with AF. Our study aims to validate the GARFIELD-AF tool using UK electronic primary care records.
We will use anonymised patient data from the CPRD, linked with Hospital Episode Statistics (HES) data, and ONS mortality data. We will include all patients aged ?18 years with a diagnosis of non-valvar AF with a minimum validated data for one year from date of diagnosis and up to 5 years from diagnosis. The primary outcome will be death from any cause, first recorded diagnosis of stroke or systemic embolism, or major bleeding within one year of diagnosis. We will also look at the 2-year and 5-year predictive ability of the tool.
Overall performance, discrimination and calibration will be assessed using the ROC statistic, the D statistic, the R2 statistic, the c-statistic and graphically.
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Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends — Kevin Wing ...
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Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-31
Organisations:
Kevin Wing - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeremy Brown - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeremy Brown - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Contraceptive use (hormone based user dependent methods, user independent non-permanent methods and user independent permanent methods); Pregnancy; Reasons for Medication Discontinuation; Pregnancy Testing
Description: Technical Summary
The aim of this study is to evaluate the impact of regulatory action taken in 2018 to prevent pregnancy in women taking valproate medication. We will measure the prevalence and incidence of valproate use amongst women of child bearing potential between 2010 and 2020 using Poisson regression and stratified by age group and most likely indication for valproate use (epilepsy, bipolar disorder and migraine), based on recorded diagnoses. We will determine whether prescribing patterns changed in 2018, using an interrupted time series (ITS) design with segmented Poisson regression. We will assess whether prescribers have been adhering to newly introduced prescribing recommendations for valproate, by looking for evidence of pregnancy testing, contraceptive use and pregnancy occurrence in women receiving valproate, again contrasting the time before and after the action taking in 2018, using ITS analysis. We will also attempt to ascertain where possible, reasons for valproate discontinuation before and after the regulatory action (e.g. pregnancy, desire to become pregnant, adverse drug reaction), and usage patterns for alternative medications that patients may have been switched to or have initiated instead of valproate. Overall, we will be able to make conclusions about the effectiveness of the regulatory action, in terms of prescribing and pregnancy prevention behaviour, and ultimately in terms of numbers of women who become pregnant whilst receiving valproate.
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CARPE-DM (CARdiometabolic multi-morbidity and CKD-related outcomes: A clinical Practice rEsearch datalink observational study in Diabetes Mellitus) — David Webb ...
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CARPE-DM (CARdiometabolic multi-morbidity and CKD-related outcomes: A clinical Practice rEsearch datalink observational study in Diabetes Mellitus)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-03
Organisations:
David Webb - Chief Investigator - Leicester Diabetes Centre
Sophia Abner - Corresponding Applicant - University of Leicester
Briana Coles - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Samuel Seidu - Collaborator - Leicester Diabetes Centre
Sharmin Shabnam - Collaborator - Leicester Diabetes Centre
Simona Boccaletti - Collaborator - Merck Sharp & Dohme - UK
Tobi Adeyemi - Collaborator - Merck Sharp & Dohme - UKOutcomes:
 primary (from CPRD) and secondary (from HES) resource use, as measured by number and mean rate of consultations
 time to development of severe CKD
 time to all-cause and CKD-related mortality
 relationship between prognostic factors, treatment (antidiabetic and cardiovascular medication) and severe CKD/CKD-related mortalityDescription: Technical Summary
Although CKD has been extensively studied in relation to individual risk factors, its association with cardiometabolic multimorbidity (a combination of T2DM and CHD/stroke) is poorly understood.
The study objectives are to use real world data to explore the influence of cardiometabolic multimorbidity (T2DM and CHD/Stroke) on the trajectory of age-related decline in renal function and other kidney disease outcomes by:
Cardiometabolic Multimorbidity:
1) Describe primary (from CPRD) and secondary resource (from HES) use over time, by multimorbidity status, stratified by age, sex, and ethnicity, as measured by number of consultations in different settings (Objective 1).CKD-related:
2) Assess time to development of severe CKD, as measured by a diagnosis of CKD or dialysis (Objective 2).
3) Assess time to all-cause and CKD-related mortality as measured by a diagnosis of CKD or dialysis (Objective 3).
4) Assess the relationship between prognostic factors, treatments (antidiabetic and cardiovascular medication) and severe CKD/CKD-related mortality (Objective 4).We will use CPRD Gold and linked hospital episode statistics (HES) to investigate all adults (?18 years) registered in CPRD that have been diagnosed with: (i) cardiometabolic multimorbidity (ii) T2DM only; (iii) CHD/stroke only, during 01/01/2000-12/31/2018. The objectives will be achieved by combining descriptive statistics (rates, means, standard deviations/medians and IQR; objective 1) and time-varying flexible parametric survival methods (objective 2, 3 and 4).
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Developing and Validating a Prognostic Model for All-Cause Mortality Patients with Heart Failure — Stephen Weng ...
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Developing and Validating a Prognostic Model for All-Cause Mortality Patients with Heart Failure
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-21
Organisations:
Stephen Weng - Chief Investigator - University of Nottingham
Habibullah Muhammad-Kamal - Corresponding Applicant - University of Nottingham
Barbara Iyen - Collaborator - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of NottinghamOutcomes:
All-cause mortality, positive predictive value, negative predictive value, specificity, sensitivity, accuracy
Description: Technical Summary
Background: Existing evidence indicates that there are a range of factors that predispose a patient with heart failure to mortality, with BMI being a poorly understood risk factor. Adding to this, in current practise, there are no prognostic models used to predict the long-term risk of mortality in patients with heart failure.
Aim: Develop and validate prognostic models for mortality in patients with heart failure.
Design: Retrospective open cohort study
Setting: General practices in UK providing data to the CPRD database. Cohort design.
Participants: Adult with new diagnosis of heart failure identified from practices with HES linkage, registered for at least one year before the study start date (date of heart failure diagnosis)
Outcomes: All cause-mortality
Methods: Multivariable cox regression model will be used to create a 45 year prognostic model for all-cause mortality in patients with heart failure, at any point during the study period. This will be compared with a gradient boosting machine learning model for the same outcome.
Outputs: Two prognostic models for heart failure mortality. One through statistical methods and another through data-driven methods. Determination of the effect of obesity on heart failure prognosis.
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Investigating the risk of serious adverse events associated with the use of gabapentinoids in patients with chronic non-cancer pain in primary care — Li...
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Investigating the risk of serious adverse events associated with the use of gabapentinoids in patients with chronic non-cancer pain in primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-16
Organisations:
Li-Chia Chen - Chief Investigator - University of Manchester
Xinchun Gu - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Douglas Steinke - Collaborator - University of Manchester
Teng-Chou Chen - Collaborator - University of ManchesterOutcomes:
Serious adverse events related to gabapentinoids: hospital admission due to bone fracture of major arthrosis (exclude stress and pathological bone fracture); drug-related death; hospital admission or death due to suicide.
Description: Technical Summary
Gabapentin and pregabalin (known as ÂgabapentinoidsÂ) are medicines indicated for focal seizure and neuropathic pain. In the past decade, there has been a marked increase of gabapentinoids prescribed in the United Kingdom (UK) primary care setting predominantly for patients with chronic non-cancer pain (CNCP). There is also an increase in drug-related deaths involving gabapentinoids. Due to the concern in misuse, abuse and illegal diversion, gabapentinoids were classified as controlled C drugs in the UK from 1st April 2019. Previous literature found gabapentinoids increased the risk of death in opioid users, probably by enhancing the respiratory inhibition led by opioids. Furthermore, case reports found a risk of suicide in gabapentinoid users. However, there is currently no study assessing these safety issues using healthcare databases in the UK. This study aims to evaluate the risk of serious adverse events in gabapentinoid users with CNCP by different epidemiology study designs using a UK primary care database. Firstly, a cross-sectional study will describe the trend and pattern of gabapentinoid utilisation in patients with CNCP by using data from CPRD. Secondly, a matched-cohort study will assess the prevalence of bone fracture, drug-related death and suicide between gabapentinoids users and their matched control by using CPRD linking to HES and ONS death registry. Thirdly, a nested case-control study will investigate the effect of combining gabapentinoids with other analgesics on drug-related death. Finally, two self-controlled studies will assess the risk of bone fracture and suicide (both suicidal behaviour and completed suicide) in different periods of exposure in gabapentinoid users with CNCP. The results of the study will provide important medication safety information to inform clinical decision-making. It will help general practitioners identify risk factors that may increase the risk of adverse events during the period that needs strict monitoring and reduce the risk of gabapentinoids.
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Examining the prevalence and adverse effects of drug-drug interactions involving antipsychotic medication — Darren Ashcroft ...
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Examining the prevalence and adverse effects of drug-drug interactions involving antipsychotic medication
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-16
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Matthew Carr - Corresponding Applicant - University of Manchester
Pearl Mok - Collaborator - University of Manchester
Richard Keers - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of Manchester
Tony Avery - Collaborator - University of NottinghamOutcomes:
 Neutropenia/agranulocytosis
 Aspiration pneumonia
 Major adverse cardiovascular events (MACE) incorporating specifically:
- Stroke
- Myocardial infarction
- Cardiovascular death
 All-cause mortalityDescription: Technical Summary
The addition of another medication to an antipsychotic treatment regimen can potentially induce a pharmacokinetic and/or pharmacodynamic (PKPD) interaction. We aim to produce evidence to support or refute some of theinteractions that have been postulated via assumed bio-chemical mechanisms, but which remain unsubstantiated from an empirical perspective (Preston, 2019).
Defined DDI mechanisms are consistent: either one drug (the precipitant) causes the interaction by affecting the absorption, distribution, metabolism or excretion of another drug (the object) or there is an additive effect of the two drugs occurring via a pharmacodynamic process. A potential consequence of a PKPD antipsychotic DDI is a change in the antipsychotic (object) drugs plasma concentration, which can subsequently affect the toxicity/efficacy of the antipsychotic. It is hypothesised that many DDIs involving antipsychotic drugs are caused by additional drugs that affect the metabolism of the antipsychotic in the liver via induction or inhibition of the cytochrome P450 family of enzymes. However, an empirical evidence-base relating to the impact of these proposed interactions is lacking.
Longitudinal electronic health records provide an important resource for assessing the frequency of DDIs and for estimating the impact on risks of adverse events. We aim to utilise the CPRD and its linked datasets, to estimate the prevalence of DDIs in primary care, and to gauge the level of variation that is specific to individual general practices. We plan to use a time-dependent cohort design and self-controlled methods to identify potential risk associations between proposed DDIs and a range of adverse outcomes including major cardiovascular events.
Practice-level variation in the prevalence of proposed interactions will be quantified using mixed effects logistic regression. Risk ratios in the time-dependent cohort studies will be estimated using Cox regression models. For the self-controlled designs, the data will be analysed using matched-pair odds ratios and incidence rate ratios.
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Heart failure burden of illness and characterisation of patients by treatments, comorbidities and ejection fraction  an observational study — Jil Billy Mamza ...
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Heart failure burden of illness and characterisation of patients by treatments, comorbidities and ejection fraction  an observational study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-03
Organisations:
Jil Billy Mamza - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Jil Billy Mamza - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Amitava Banerjee - Collaborator - University College London ( UCL )
Andrew Coats - Collaborator - University of Warwick
Cathy Emmas - Collaborator - Astra Zeneca Ltd - UK Headquarters
Eleni Rapsomaniki - Collaborator - Astra Zeneca Ltd - UK Headquarters
Gengshi Chen - Collaborator - Astra Zeneca Ltd - UK Headquarters
George Godfrey - Collaborator - Astra Zeneca Ltd - UK Headquarters
Johan Bodegård - Collaborator - Astra Zeneca Inc - USA
Martin Cowie - Collaborator - King's College London (KCL)
Phillip Hunt - Collaborator - Astra Zeneca Inc - USA
Ping Sun - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ruiqi Zhang - Collaborator - Astra Zeneca Ltd - UK Headquarters
Supriya Kumar - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
The study outcomes are aligned to the core objectives of this study and described below.
Primary objective: Cardiovascular, renal outcomes and metabolic outcomes
Primary outcomes include composite and individual components of specific hospitalisations for heart failure (HF), myocardial infarction (MI), stroke, peripheral artery disease (PAD), renal outcomes (including hospitalisation for kidney disease and end-stage renal disease [ESRD]), cardiovascular and all-cause death, and their associated risk factors. Other outcomes include, percutaneous coronary interventions, coronary artery bypass graft surgery, heart transplant surgery.
Secondary objective: Health care cost of heart failure
Secondary outcomes include monetised costs of health care resource use; resources include disease management services in the clinical guideline, e.g., GP consultations, laboratory tests, medications and hospitalisations. Others include urgent care visits, emergency department attendances, heart transplant surgery and devices.Description: Technical Summary
Using a cohort of patients with heart failure, we will describe and compare the characteristics of heart failure patients over time, including the epidemiology of HF in various subgroup populations and patterns of adverse complications. This study will utilise both CPRD Aurum and CPRD GOLD database and the study period will begin on 1 January 2007 and will end on 30 September 2019. Each of the clinical outcomes of interest will be described separately. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Survival distributions utilising Kaplan-Meir method will describe time to cardiovascular (CV) or renal disease progression, time to CV- and all-cause mortality. Relative risks and risk factors associated with outcomes will be estimated using Cox proportional hazard models. In addition, we aim to further evaluate the care pathways of the patients to describe health resource use including GP consultations, laboratory tests or measurements, medication, referrals to specialist and hospital admissions. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
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Use of electronic primary care records to obtain control populations for assessing excess risk of long-term morbidity and mortality in chronic diseases — Michael Sweeting ...
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Use of electronic primary care records to obtain control populations for assessing excess risk of long-term morbidity and mortality in chronic diseases
Datasets:GP data, Primary outcome: All-cause and cause-specific mortality identified from ICD 9-10 codes within the CPRD-ONS linked mortality data; Secondary outcome: Incident primary cancers identified from Read codes (CPRD GOLD) and ICD-10 codes (HES APC) (see Appendix 1 for link to code list; derived from Strongman et al. Lancet 2019); Secondary outcome: Non-fatal CVD (coronary artery disease, stroke, heart failure, cardiomyopathy, pericarditis, valvular heart disease and peripheral vascular disease) identified from Read codes (CPRD GOLD) and ICD-10 codes (HES APC) (see Appendix 2 for link to code list; derived from Strongman et al. Lancet 2019)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-06
Organisations:
Michael Sweeting - Chief Investigator - University of Leicester
Michael Sweeting - Corresponding Applicant - University of Leicester
Aiden Smith - Collaborator - University of Leicester
Claire Lawson - Collaborator - University of Leicester
David Adlam - Collaborator - University of Leicester
James Schmidt - Collaborator - University of Leicester
Mark Rutherford - Collaborator - University of Leicester
Paul Lambert - Collaborator - University of Leicester
Umesh Kadam - Collaborator - University of LeicesterOutcomes:
Primary outcome: All-cause and cause-specific mortality identified from ICD 9-10 codes within the CPRD-ONS linked mortality data;
Secondary outcome: Incident primary cancers identified from Read codes (CPRD GOLD) and ICD-10 codes (HES APC) (see Appendix 1 for link to code list; derived from Strongman et al. Lancet 2019);
Secondary outcome: Non-fatal CVD (coronary artery disease, stroke, heart failure, cardiomyopathy, pericarditis, valvular heart disease and peripheral vascular disease) identified from Read codes (CPRD GOLD) and ICD-10 codes (HES APC) (see Appendix 2 for link to code list; derived from Strongman et al. Lancet 2019)
Description: Technical Summary
There is, now more than ever, an untapped opportunity to utilise disease registry data to address key questions regarding the lifecourse of patients following diagnosis for either cancer or cardiovascular disease stemming from a) continuing increases in scale of registry data, b) longer-term follow-up, and c) possible linkages with other routinely-collected electronic records that record morbidity and mortality.
A key aim of our cardio-oncology research programme at the University of Leicester is to use national registry data to determine whether there are excess rates of morbidity and mortality in chronic disease populations and to understand determinants of variations in excess rates. However, to address such questions, control populations are required so that we can ascertain whether rates of morbidity and mortality are in excess of what would be expected for comparable people without the chronic disease of interest.
This study will utilise data from primary care records from CPRD. The aim will be to produce lifetables with expected mortality and incidence rates stratified by different types and severity of comorbidities. These lifetables can then be fed into other models (e.g. relative survival / excess rate models). However, we first need to ascertain how representative mortality rates are in CPRD compared to the general population. In addition it is important to assess whether selection of specific subject groups impacts on how representative these mortality rates are.
Hence the research will provide a resource for various applied analyses where it is important to ensure expected rates from the reference population represent the rates the exposed (chronic disease) population would have experienced had they been unexposed. Lifetables have previously been published stratified by socio-economic deprivation (https://csg.lshtm.ac.uk/tools-analysis/uk-life-tables/). Our work will extend such ideas to incorporate comorbidity stratification. The study will use Poisson regression and flexible parametric survival modelling as previously described (Bower AJE 2018) to derive these expected rates.
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with peripheral artery disease (PAD) and with PAD related lower-extremity revascularization (PAD-LER) — Jennifer Quint ...
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with peripheral artery disease (PAD) and with PAD related lower-extremity revascularization (PAD-LER)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-31
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Laura Portas - Corresponding Applicant - Imperial College London
Alexander Cohen - Collaborator - King's College London (KCL)
Jean Baptiste Briere - Collaborator - Bayer AG
Rupert Martin Bauersachs - Collaborator - Klinikum Darmstadt GmbH
Varun Sundaram - Collaborator - Imperial College London
William Schuyler Jones - Collaborator - Duke UniversityOutcomes:
ÂÂ Â Â Â Â Â Â Incidence of first-time ever PAD related revascularizations and incidence of revascularization re-occurrence, overall and by type of procedure
 Treatment patterns (with a focus on standard of care) in patients with PAD related revascularizations
 Risk and incidence of complications (e.g. major cardiovascular events, bleeding) among patients with PAD related revascularizations
 Health resource utilisation (HRU) related to PAD complications in patients with PAD related revascularizations
 Risk/incidence of complications, HRU and treatment patterns among subgroups of interestDescription: Technical Summary
Two sets of patient cohorts will be needed to answer the study questions. One cohort which will be used to calculate incidence of first-time ever PAD related revascularization (overall and by type of procedure), will include all incident patients diagnosed with PAD above the age of 18 years and registered with a general practice for at least one year. These patients will be followed-up until the occurrence of any revascularization procedure or a major study end point (i.e. the patient disenrolls from the practice or the practice disenrolls from CPRD, the patient dies, end of the study period on 31st December 2018). Demographics, health behaviors (e.g. smoking, alcohol consumption) and clinical characteristics will be described over a 1-year period prior to the index date.
Patients will enter the second cohort if they underwent a PAD related revascularization. The second cohort will be used to estimate the incidence of revascularization re-occurrence, the risk/incidence of PAD-related complications as well as to describe health resource utilization (HRU) and treatment patterns. Differences in patient characteristics, disease complications, health resource utilization, and treatment patterns will be also explored among subgroups of patients with PAD related revascularization. The study will be undertaken utilizing linked data within the Clinical Practice Research Datalink with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases.
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Factors associated with progression of chronic kidney disease from stage 3 to 5 in patients with diabetes (PRIDE) — Angus Forbes ...
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Factors associated with progression of chronic kidney disease from stage 3 to 5 in patients with diabetes (PRIDE)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-30
Organisations:
Angus Forbes - Chief Investigator - King's College London (KCL)
Hellena Habte-Asres - Corresponding Applicant - King's College London (KCL)
David Wheeler - Collaborator - University College London ( UCL )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Trevor Murrells - Collaborator - King's College London (KCL)Outcomes:
The outcomes identified below related to the two study aims (as identified in section E,)
Aim 1- Primary Outcome: The development of end stage kidney disease (ESKD, CKD stage 5) requiring dialysis or transplantation or a sustained estimated GFR <15ml per minute per 1.73 m2 for at least 90 days according to last available eGFR result.
Secondary Outcome: Changes in estimated glomerular filtration rate (eGFR) from baseline to final follow up point.
Aim 2- Primary Outcome: Diabetes related hospitalisation and accident and emergency attendance in CKD patients with comorbid diabetes.Description: Technical Summary
Background: Diabetes is the leading cause of chronic kidney disease (CKD). Diabetes patients with co-morbid CKD are a high-risk population, with an accelerated rate of progression to end-stage-kidney-disease (ESKD) and higher mortality compared to people without diabetes. People with diabetes are three and half times more likely to need renal replacement therapy (RRT) than the general population. Treating advanced kidney disease in people with diabetes is very costly and is consuming a growing proportion of NHS resources. Therefore, identifying strategies to improve the management of CKD is of high importance. Kidney function decline in people with diabetes is associated with multiple factors. While glucose exposure and hypertension are the most established risk factors, we have identified some less well studied and potentially modifiable factors that may indicate some additional therapeutic targets. These factors include glycaemic variability and depression.
Aim: The aim of this study is to estimate the risk contribution of glycaemic variability and depression to progression of CKD from stage 3 onwards in patients with diabetes. A secondary aim will be to model the risk hazards (hospitalisation and emergency-department attendance) associated with different hypoglycaemic agents in the advanced CKD population.
Method: A retrospective observational study using the Clinical Practice Research Datalink (CPRD) to model the identified risk factors using cumulative incident function analysis. The proposed risk modelling of hypoglycaemic agents will require linkage to HES (Admitted-Patientcare and A&E).
Outcome to be measured: The primary observation of interest will the development of ESKD (CKD stage 5) requiring dialysis or transplantation or a sustained eGFR <15ml/min/1.73m2 for >90 days according to last available eGFR result. Diabetes related hospitalisation and accident and emergency attendance in CKD patients with comorbid diabetes. Secondary outcomes will include changes in eGFR from baseline to final follow up point.
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Evaluation of the associations between variability of cardiovascular risk factors and risk of cardiovascular and non-cardiovascular diseases — Darren Ashcroft ...
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Evaluation of the associations between variability of cardiovascular risk factors and risk of cardiovascular and non-cardiovascular diseases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-03
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Darren Ashcroft - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
David Reeves - Collaborator - University of Manchester
Eric Yuk Fai Wan - Collaborator - University of Hong Kong
Evangelos Kontopantelis - Collaborator - University of Manchester
Ian Wong - Collaborator - UCL School Of Pharmacy
Jessica Barrett - Collaborator - University of Cambridge
Mamas Mamas - Collaborator - Keele University
Martin Rutter - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
Primary outcome
Incident non-fatal myocardial infarction, non-fatal stroke or cardiovascular-related mortality
Secondary outcome
Incident all-cause mortality; non-fatal myocardial infarction, non-fatal stroke, cardiovascular-related mortality; haemorrhagic stroke (outcomes individually)
Tertiary outcome
Incident: heart failure; atrial fibrillation; peripheral arterial disease; chronic kidney disease unspecified stroke; aortic aneurysm; deep vein thrombosis; pulmonary embolism; dementia; non-CVD-related mortality; cancer.Description: Technical Summary
The detrimental effects of variability in cardiovascular risk factors, such as blood pressure, glucose, cholesterol concentration, body mass index and estimated glomerular filtration rate on the risk of cardiovascular and non-cardiovascular diseases remains unclear. This study aims to evaluate the association of variability of cardiovascular risk factors with the risk of cardiovascular and non-cardiovascular diseases. The retrospective cohort study will be conducted on patients aged ?18 years old at cohort entry between 2005 and 2010. Eligible patients will be followed-up to 2019. The exposure is the standard deviation, degree of change and rate of change of measurements of cardiovascular risk factors. The primary outcome is the first event of cardiovascular disease including ischaemic heart disease, stroke and CVD mortality. The secondary outcomes are the ischaemic heart disease, haemorrhagic stroke, ischaemic stroke and haemorrhagic stroke. The tertiary outcomes include atrial fibrillation, chronic kidney disease, pulmonary embolism, heart failure, deep vein thrombosis, stroke unspecified; aortic aneurysm; dementia; all-cause mortality, non-CVD-related mortality and cancer. Our proposed outcome measures will be determined from the diagnoses and mortality records, and thus CPRD will be linked with (i) ONS Death Registration Data and (ii) HES Admitted Patient Care. To deal with random errors in this variability measurement, the joint model (mixed effects submodel and time-to-event submodel simultaneously using shared random effects) will be applied to estimate the variability of cardiovascular risk factors (standard deviation) based on the mixed effect model, and then the associations between the variability of cardiovascular risk factors and risk of cardiovascular and non-cardiovascular diseases will be evaluated by Cox proportional hazards regression adjusted for patient characteristics. Subgroup analyses will be conducted, stratifying by subject baseline characteristics, including age, gender, deprivation, smoking status, blood pressure level, the type of anti-hypertensive drugs, number of types of anti-hypertensive drugs, hypertension; diabetes and Charlson comorbidity index.
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Cardiomyopathy in pregnancy and future risk of cancer: a cohort study of women in the United Kingdom between 1987 and 2017 — Pensee Wu ...
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Cardiomyopathy in pregnancy and future risk of cancer: a cohort study of women in the United Kingdom between 1987 and 2017
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-03
Organisations:
Pensee Wu - Chief Investigator - Keele University
James Bailey - Corresponding Applicant - Keele University
Carolyn Chew-Graham - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele UniversityOutcomes:
(1) Any cancer.
(2) Site-specific cancers, to include the top 3 commonest cancers in UK females  breast, lung and colon cancers.
(3) Cancer mortality.Description: Technical Summary
Background
The incidence of peripartum cardiomyopathy is increasing, which may be due to the rising rates of advanced maternal age, pre-eclampsia, multiple pregnancies (which is partly due to increased use of assisted reproductive technologies) and comorbidities in women of reproductive age. Despite improvements in short-term prognosis, some studies have linked cardiomyopathy in pregnancy with an increased future risk of cancer. However, there have been no large-scale studies to confirm the association and to quantify the level of risk.Objective
To investigate the associations between peripartum cardiomyopathy and future diagnosis of cancer.Methods
Using a comparative cohort design, we will compare women with and without cardiomyopathy (ÂexposureÂ), who had pregnancies between 1987 and 2017. They will be followed for future cancer until incident event, 31st December 2019, last data collection or until they no longer contribute to CPRD due to leaving practice, death, or the practice leaving CPRD.Data analysis
The baseline cancer risk factors will be compared between women with and without cardiomyopathy, using Chi-squared tests for categorical variables and t-tests for continuous variables. The independent associations between peripartum cardiomyopathy and future cancer will be investigated using Cox proportional hazards model, adjusting for other potential risk factors. We will then assess differences in strength of the association of other risk factors with cancer between women with and without peripartum cardiomyopathy using interaction terms.
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Real World Effectiveness and Adverse Events Caused by ACE inhibitors and ARBs for Reduction in Cardiovascular Events — Laurie Tomlinson ...
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Real World Effectiveness and Adverse Events Caused by ACE inhibitors and ARBs for Reduction in Cardiovascular Events
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-31
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Paris Baptiste - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Heide Stirnadel-Farrant - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The outcomes are listed below, based on the outcomes from the ONTARGET/TRANSCEND trials. How each component of the outcome will be identified in the CPRD cohort is shown in Table 1. in Appendix 1.
 Primary outcome: Cardiovascular death, non-fatal MI, non-fatal stroke or hospitalisation for congestive heart failure
 Each component of the primary outcome will also be studied as a secondary outcome
 Secondary outcomes: Newly diagnosed congestive heart failure, revascularization procedures, and nephropathy
 Other outcomes: All-cause mortality and microvascular complications of diabetes mellitus
 Safety outcomes: Cough recorded both as a Read Code and adverse event: cough, angioedema, hyperkalaemia or renal dysfunctionDescription: Technical Summary
We will use HES linked CPRD data to select patients prescribed ACE inhibitors, ARBs or both and from this select those that are thought to be at high risk of cardiovascular events, i.e. those with coronary, peripheral or cerebrovascular disease or diabetes with end-organ damage. We will then create a population in CPRD with similar characteristics to the ONTARGET/TRANSCEND trial population by applying their inclusion/exclusion trial criteria. We will use multivariable Cox regression to calculate the absolute and relative rates/risks (whichever is more appropriate) for the primary composite outcome of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalisation for congestive heart failure and also the secondary and safety outcomes.
The analysis will be repeated after having applied a matching technique, such as propensity score matching, to ensure that patients in the two comparison groups from both the CPRD cohort and the randomised trials are similar, which we have approved access to anonymised individual participant data. If the absolute and relative rates/risks from analysis of the matched cohort are similar to those from applying the inclusion/exclusion criteria this will suggest that matching has no additional benefit in replicating a clinical trial in this specific therapeutic area.
Either using the CPRD trial-analogous cohort, or a matched cohort (if shown to be important), we will extend the analysis to subgroups that were underrepresented in the trials (adjusting the inclusion/exclusion criteria as necessary) such as those aged >75 years, from ethnic minority groups or with poor renal function. We will use a variety of modelling approaches to determine how to expand the population of trial-underrepresented subgroups within the CPRD population. However, if matching does have an effect in replicating the trial it will also be used here. Finally, we will observe the outcomes over a longer time period than studied in the clinical trial.
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Incidence of venous thromboembolism following colorectal resectional surgery — David Humes ...
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Incidence of venous thromboembolism following colorectal resectional surgery
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-31
Organisations:
David Humes - Chief Investigator - University of Nottingham
David Humes - Corresponding Applicant - University of Nottingham
Christopher Lewis-Lloyd - Collaborator - University of Nottingham
Colin Crooks - Collaborator - University of NottinghamOutcomes:
·       Incidence of VTE
Description: Technical Summary
Background: Venous thromboembolism is an important complication after surgery and is associated with an increased risk of morbidity and mortality. In 2010 the National institute for clinical excellence (NICE) made recommendations regarding VTE assessment, prevention and treatment and CQUIN (Commissioning for Quality and Innovation) targets were introduced to promote adherence to these guidelines. They also made recommendations regarding future research directions, having acknowledged the paucity of evidence in the form of population estimates of incidence of VTE after surgery.
Since then studies into VTE, some from our group have shown that gastrointestinal surgery and in particular gastrointestinal cancer surgery carries a much larger risk of VTE. What is still lacking is evidence of how the implementation of VTE assessment and risk prevention strategies have impacted incidence.
Objective: To quantify the risk of VTE following colorectal surgery, in the 9yrs before and 9yrs after the implementation of NICE guidelines on VTE, in order to assess the impact guidelines have had on both risk and rates of VTE.
Design: The linked primary and secondary care databases (Clinical Practice Research Datalink, Hospital Episode Statistics) together with mortality data from the Office of National Statistics will be used to establish a cohort of patients undergoing colorectal resectional surgery. The incidence of VTE following colorectal surgery will be calculated as rates per 100000 person years of follow up. We will control for the confounders of age, gender, BMI, smoking, malignant and benign disease, along with emergency and elective admission and whether the procedure was performed laparoscopically.
Outcomes: We will provide population based estimates of the incidence of VTE following colorectal surgery, comparing incidence rates pre and post 2010.
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Comparison of the prevalent new user and active comparator new user designs for assessing the real-world safety and effectiveness of medications — Daniel Gibbons ...
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Comparison of the prevalent new user and active comparator new user designs for assessing the real-world safety and effectiveness of medications
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-08
Organisations:
Daniel Gibbons - Chief Investigator - GSK
John Tazare - Corresponding Applicant - GSK
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Logie - Collaborator - GlaxoSmithKline - UK
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
This is a methodological study. We assess several study designs in the context of a cohort study, with the following outcome:
Upper gastrointestinal bleeding leading to hospitalisation or death. .
Description: Technical Summary
The active comparator new user (ACNU) study design has become the gold-standard for conducting cohort studies to assess the real-world safety and effectiveness of medications 1. The attractiveness of the ACNU approach is largely due to the baseline washout period (mimicking a clinical trial) and using an active comparator to reduce confounding by indication.
However, one issue with the ACNU is the selection of a suitable comparator drug. Often the comparator is an older drug that has been on the market for a long time. In the patient population, this means that many new users of the study drug are not, in fact, treatment naïve but have instead switched to the newer drug from the old comparator. The ACNU would typically exclude those who switched from the comparator drug to the study drug and this can result in investigators mischaracterising the real world patient population. The newly proposed Prevalent New User (PNU) design aims to address this limitation by incorporating patients who have switched from the older drug to the newer drug.
In this study, we aim to provide an assessment of the PNU design and proposed variations of defining exposure sets compared to the existing ACNU design. Furthermore, we will investigate the use of high-dimensional propensity scores (hd-PS) for confounder adjustment in the context of PNU designs and provide initial guidance to investigators planning to combine these approaches.
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Examining neurologic and thromboembolic risks when using skeletal muscle relaxants with warfarin — Darren Ashcroft ...
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Examining neurologic and thromboembolic risks when using skeletal muscle relaxants with warfarin
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-17
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Matthew Carr - Corresponding Applicant - University of Manchester
Charles Leonard - Collaborator - University of Pennsylvania
Sean Hennessy - Collaborator - University of Pennsylvania
Warren Bilker - Collaborator - University of PennsylvaniaOutcomes:
 Venous thromboembolism
 StrokeDescription: Technical Summary
Drug interactions with anticoagulant therapy are a major, preventable cause of harm. To improve knowledge on anticoagulant safety, we plan to conduct bidirectional self-controlled case series studies, among concomitant users of warfarin and a skeletal muscle relaxant and, as pre-specified negative control comparators, among concomitant users of an inhaled corticosteroid and a skeletal muscle relaxant. Each study will examine a composite outcome of venous thromboembolism / ischemic stroke.
Data will be obtained from both CPRD GOLD and CPRD Aurum with linkage to Hospital Episode Statistics and ONS mortality records. The study populations will consist of any individual initiating warfarin (the object drug of interest, the affected agent in a drug interaction pair) and inhaled corticosteroids (the prespecified negative control object drug). Among object drug users, we will define periods of exposure and non-exposure to skeletal muscle relaxants (precipitant drugs, affected agents in a drug interaction pair). We will limit each cohort to individuals experiencing the outcome of interest during their observation period.
We will dichotomise each day of the observation period as a risk or non-risk day, based on the presence or absence of exposure to a skeletal muscle relaxant. We will use conditional Poisson regression models to estimate incidence rate ratios and 95% confidence intervals and conduct sensitivity analyses to examine the robustness of our findings and assess potential violations of the self-controlled case series designÂs underlying assumptions.
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Treatment Patterns, Effectiveness and Safety for Secondary Stroke Prevention among Patients with Ischemic Stroke or Transient Ischemic Attack — Jenny Jiang ...
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Treatment Patterns, Effectiveness and Safety for Secondary Stroke Prevention among Patients with Ischemic Stroke or Transient Ischemic Attack
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-06
Organisations:
Jenny Jiang - Chief Investigator - Bristol-Myers Squibb - USA ( BMS )
Jenny Jiang - Corresponding Applicant - Bristol-Myers Squibb - USA ( BMS )
Shrutika Dixit - Collaborator - Mu SIgmaOutcomes:
1.     Stroke: Ischemic stroke(IS); haemorrhagic stroke(HS)
2. Myocardial Infarction:
3. Mortality : CV-related Mortality, All-cause Mortality:
4. Major bleeding events: intracranial hemorrhage (ICH); gastrointestinal (GI) bleeding; other MB
5. Major Adverse Cardiac Events (MACE)
a. Overall stroke, MI, CV-related mortality
b. Overall stroke, MI, all-cause mortality
6. TIADescription: Technical Summary
The primary aim of this study is to examine medication treatment patterns (antiplatelet therapy) for second stroke prevention (SSP) among non-atrial fibrillation patients who have experienced their 1st hospitalized transient ischemic attack (TIA) or ischemic stroke (IS) event. Other objectives include: (1) comparing demographics and clinical characteristics of all patients; (2) assessing the incidence rate of stoke, TIA, myocardial infarction, bleeding and mortality post 1st hospitalized TIA or IS event. Subgroups analyses will be examined such as IS patients, TIA patients, elderly patients and by calendar year(s). An exploratory objective will be to assess the treatment pattern among patients with non-hospitalized TIA (ER visits not leading to hospitalization).
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Predictors of cardiovascular event risk in a population with Atherosclerotic Cardiovascular Disease (ASCVD) or Heterozygous Familial Hypercholesterolemia (HeFH) — Naomi Boxall ...
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Predictors of cardiovascular event risk in a population with Atherosclerotic Cardiovascular Disease (ASCVD) or Heterozygous Familial Hypercholesterolemia (HeFH)
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-31
Organisations:
Naomi Boxall - Chief Investigator - IQVIA Ltd
Zainab Mohamoud - Corresponding Applicant - IQVIA Ltd
- Collaborator -
Caroline O'Leary - Collaborator - IQVIA Ltd
Jessica Lundbom - Collaborator - IQVIA Ltd
Silvia Narduzzi - Collaborator - IQVIA
Suvi Hokkanen - Collaborator - IQVIA LtdOutcomes:
Outcomes of this study will be one-year event rates of the primary and secondary CV endpoints, the frequency of demographic, clinical and medication characteristics, and predictors of CV risk.
Primary Endpoint:
 Composite of: nonfatal myocardial infarction (MI), unstable angina (UA) with hospitalization, elective coronary revascularization, nonfatal ischemic stroke, and CV deathSecondary Endpoints:
 Composite of: nonfatal MI, UA with hospitalization, elective coronary revascularization, nonfatal ischemic stroke, and all-cause-death
 Individual components of the primary and secondary endpoints: nonfatal MI, UA with hospitalization, elective coronary revascularization, nonfatal ischemic stroke, CV death, and all-cause deathDescription: Technical Summary
The risk of cardiovascular (CV) events in individuals with established atherosclerotic cardiovascular disease (ASCVD) is not well described in the Âreal-worldÂ. Data from randomized clinical trials suggest that CV event rates in this population are influenced by the type of ASCVD (e.g. coronary vs. peripheral disease), the timing since past events, and concurrent comorbid conditions such as diabetes mellitus. This study will assess the patterns of CV risk in the patients with ASCVD or Heterozygous Familial Hypercholesterolemia (HeFH) using primary care data from the UK (CPRD). Patients with ASCVD or HeFH diagnoses recorded in the 2 years before the index date of 1st January 2010 will be identified. A 2-year baseline period before index will be used to establish patient demographic, clinical and medication characteristics. Patients will be followed for CV events over time until the end of the available data, with censoring at death or transfer out, first occurrence of underlying individual component or end of data availability. Descriptive summary statistics, Kaplan-Meier analysis, and a Cox proportional hazards regression model adjusted for potential confounders will be applied to evaluate one-year event rates of CV events and predictors of CV risk. Results of this study will be useful for understanding the public health burden of ASCVD and identification of individuals who are at highest risk for future events.
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Late or missed childhood vaccination: identifying the determinants and estimating the impact on subsequent child health outcomes — Sonia Saxena ...
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Late or missed childhood vaccination: identifying the determinants and estimating the impact on subsequent child health outcomes
Datasets:GP data, CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2020-01-30
Organisations:
Sonia Saxena - Chief Investigator - Imperial College London
Helen Skirrow - Corresponding Applicant - Imperial College London
Ceire Costelloe - Collaborator - Imperial College LondonOutcomes:
Study 1
 On time or early vaccination
 Late vaccination
 Missed vaccination
 Missed MMR vaccinationStudy 2
Same as study 1
Study 3
Primary Outcomes
 General Practice Consultation Rates
 General Practice Illness Consultations Rates
 General Practice Infective Illness Consultations RatesAll consultation types will be included: face-to-face or phone, GP or nurse practitioner.
Secondary Outcomes
 General Practice Acute Antibiotic Prescriptions rates.
 General Practice Antibiotic Prescriptions associated with Infective illness consultations rates (3).
 Vaccine Preventable Disease rates (Measles, Mumps, Rubella, Pneumococcal disease, Meningococcal type C, Pertussis). Other vaccine preventable disease outcomes not included due to rarity(29).Description: Technical Summary
Background: EnglandÂs overall high vaccination rates are declining putting individual children at risk of infectious diseases. For example, recent variable measles, mumps and rubella(MMR) vaccine uptake caused by missed and late vaccination has contributed to increased measles outbreaks. Vaccine uptake is related to health system barriers and parental attitudes, with lower uptake among some ethnicities and poorer children. Pregnant women are offered pertussis vaccine, but the relationship between motherÂs and childrenÂs vaccine uptake is unknown. There is evidence that vaccines benefit overall child health beyond preventing specific infections. However, the impact of missed or late vaccination on subsequent primary-care use and antibiotic prescribing is unknown.
Research Questions
1.Which children are at risk of being vaccinated late or missing vaccines before 5 years old?
2.Do children whose mothers are not vaccinated in pregnancy have a higher risk of being vaccinated late or missing vaccines before 5 years old?
3.Do children who are vaccinated late or who miss vaccines before 5 years old have higher annual rates of primary-care consultations and antibiotic prescribing?
Methods: Three, retrospective birth cohort-studies are proposed:
Study-1:will describe childrenÂs vaccination patterns: before 1 year, at 1 year and before 5 years. Vaccination patterns will be described by sex, ethnicity, deprivation, prematurity, breastfeeding, congenital co-morbidities and chronic illnesses.
Study-2:will link motherÂs and childrenÂs records to estimate the association between maternal pertussis vaccination and childhood vaccinations using a multi-nominal logistic regression model.
Study-3:will estimate the impact of late or missed vaccination on primary care consultation and antibiotic prescribing rates using a Poisson regression model, stratified by age-group.
Impact:Findings will inform how childrenÂs vaccine services can improve to increase vaccine uptake and protect more children against infectious diseases.
The study period will be extended to include children born beyond the original study cohort definition and include those born up until 31 December 2020.
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Retrospective Study into the Journey of Non-Alcoholic Fatty Liver Disease Patients with Advanced Fibrosis in the Integrated Health and Social Care System in North West London — Imperial College Healthcare NHS Trust...
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Retrospective Study into the Journey of Non-Alcoholic Fatty Liver Disease Patients with Advanced Fibrosis in the Integrated Health and Social Care System in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-20
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Non-Alcoholic Fatty Liver Disease. Commercial
Source
2019 - 12
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Feasibility study to explore the use of the MoJ-DfE linked dataset to aid evaluations — unknown...
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Feasibility study to explore the use of the MoJ-DfE linked dataset to aid evaluations
Where: unstated
When: 2019-12-16
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
ADR UK is funding a University of Bristol feasibility study, supported by the Home Office, into using the new Ministry of Justice-Department for Education (MoJ-DfE) linked dataset for evaluation of early interventions for violence/crime prevention. More specifically, this work will explore how well the dataset can be used to create robust matched control groups.
BackgroundSince 2014/15 there has been a sustained increase in serious violence offences in England and Wales. A systematic review of early interventions conducted for the Serious Violence Strategy in 2018 found early interventions to be the most promising approach to violence prevention. However, the review also found that there is not enough robust evidence to establish what works in England and Wales.
The MoJ/DfE linked dataset â the result of a data sharing agreement between the MoJ and DfE signed in September 2019 â has the potential to be a useful tool for measuring both short- and long-term outcomes for early interventions for violence and crime preventions (such as those funded by the Youth Endowment Fund, the Early Intervention Youth Fund or Violence Reduction Units). This feasibility study will help to identify a robust approach to measuring outcomes for early interventions to ensure early intervention funds are spent most effectively and to fill gaps in the evidence base.
The DatasetThis study will utilise the newly linked MoJ-DfE dataset - the result of a data sharing agreement between the MoJ and DfE signed in September 2019. The dataset includes data from Prison, Courts, Police National Computer, National Pupil Database, Looked-After-Children (LAC) and Children In Need (CIN) and covers variables such as demographics, offending data, school exclusions and children in care.
The ProjectThe project consists of two stages:
1. Assessing the reliability of the data included in the linked dataset.
This step will predominantly assess the reliability of variables in the linked dataset and where possible, the quality of the match.
2. Conduct a feasibility study to test if the dataset can be used to create matched control groups
The next stage will be to see if the dataset can be used to robustly match individuals to their most similar peers to create matched control groups (independent of the programme design) to be used in systematically evaluating early interventions.
Project detailsProject lead: Dr Rosie Cornish, University of Bristol.
Funded value: £79,574.45
Duration: March 2020 â April 2021*
Publications: Blog: Feasibility of using linked dataset to evaluate early interventions to prevent violent crime, Feasibility of evaluating early interventions for violence prevention: Data quality report, Feasibility of evaluating early interventions for violence prevention: Generating matched control groups
This project is funded via the ADR UK Strategic Hub Fund, a dedicated fund for commissioning research using newly linked administrative data, in consultation with the former Research Commissioning Board (RCB).
You can find out more about the team conducting this study in the annoucement of their appointment (May 2020).
*Following the completion of this project, the researchers aim to publish a series of outputs including a report of the findings.
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The association between biochemical control and clinical outcomes in acromegaly: an observational study using routine UK health data — Craig Currie ...
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The association between biochemical control and clinical outcomes in acromegaly: an observational study using routine UK health data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-12
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Chris D Poole - Corresponding Applicant - Digital Health Labs Limited
- Collaborator -
- Collaborator -
Aled Rees - Collaborator - Cardiff University
Jack Brownrigg - Collaborator - Pfizer Ltd - UK
John Ayuk - Collaborator - Queen Elizabeth Hospital
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Wensley - Collaborator - Pfizer Ltd - UKOutcomes:
All-cause mortality (primary); incident cardiovascular disease (secondary); incident cancer (secondary); incident site-specific cancers (secondary); and incident diabetes (secondary).
Description: Technical Summary
Acromegaly is caused by hypersecretion of growth hormone (GH) stimulating excess production of insulin-like growth factor 1 (IGF-1), mediating the somatic and metabolic features of the disease including somatic overgrowth, multiple comorbidities, premature mortality, and physical disfigurement.
Acromegalic patients are at risk of doubled mortality versus the general population, for which elevated rates of diabetes, hypertension, cardiovascular & respiratory disease, and some malignancies are contributory.
Routine measurement of IGF-1 is recommended in not only supporting the diagnosis of acromegaly but also as a biochemical target goal signifying disease control, however, there is a lack of consensus for target IGF-1 levels that correlate with either reduction in mortality risk or prevention of co-morbidities.
This study will describe the association between IGF-1 and all-cause mortality (ACM) in patients with acromegaly, determining not only the statistical Âshape of this relationship but also elucidating effect-modifiers of this relationship insofar as they are observable from the available clinical record.
Data from primary care will be linked to that from hospital admissions, cancer & death registrations to accurately determine exposures, outcomes, and co-variates. The primary hypothesis (association of raised IGF-1 level with all-cause mortality in acromegaly) will be tested using extended Cox proportional hazards regression modelling for post-index time-dependent effect modifiers related to acromegaly treatment. Restricted cubic spline functions will be applied to investigate not only the non-linear effects of continuous covariates but also of time-by-covariate interactions
The study outputs may help clinicians may be better able to make individualised treatment decisions relating to biochemical control in their patients with acromegaly and provide more accurate prognoses.
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Characterisation of asthma in young paediatric patients: a UK retrospective analysis — Christopher Morgan ...
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Characterisation of asthma in young paediatric patients: a UK retrospective analysis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-17
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence; asthma severity; asthma exacerbation; asthma symptoms, resource use; resource costs; mortality; lung function; blood eosinophils; asthma treatment; comorbidities
Description: Technical Summary
The study aims to estimate the diagnosed prevalence of paediatric asthma stratified by two age bands (2-5 and 6-11) and to characterise these populations by severity, symptoms, exacerbations, co-morbidity and associated resource use. Data will be selected from the Clinical Practice Research Datalink GOLD dataset for patients linked to the Hospital Episode Statistics (admitted patient care, outpatient and accident and emergency), Office of National Statistics (ONS) mortality and patient level deprivation index datasets. The study will characterise paediatric asthma in 2017/2018. Patients with asthma will be defined by Read or ICD-10 classification codes. Index date will be defined as the latter of 1st January of each year or first diagnosis of asthma and patients will be followed to study end-date defined as the earliest of 31st December of each year or end of follow-up. Point prevalence for the midpoint (30th June of each year) will be calculated using all patients within the specified age bands registered on this date as the denominator. Patients will be classified by severity according to the Global Initiative for Asthma guidelines and patients on individual medications reported. The prevalence of type-2 comorbidities (including allergic rhinitis, allergic conjunctivitis, atopic dermatitis) will be reported. Rates of asthma symptoms defined by Read code, exacerbations defined by either inpatient or accident and emergency contact or acute oral corticosteroid prescription; and mortality defined from the ONS mortality dataset will be reported between from index date and end-date. Rates of healthcare utilisation (primary care, inpatient, outpatient, accident and emergency) between index date and end-date will also be reported and costs applied based on Unit Costs of Health and Social Care for primary care and the national tariff for secondary care. Therapy costs for prescription emanating in primary care will be reported. Descriptive summaries of blood eosinophils and lung function tests will also be reported.
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Improved characterization of the overlap syndrome of heart failure, diabetes mellitus and chronic kidney disease — Jil Billy Mamza ...
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Improved characterization of the overlap syndrome of heart failure, diabetes mellitus and chronic kidney disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-17
Organisations:
Jil Billy Mamza - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Laura Pasea - Corresponding Applicant - University College London ( UCL )
Amitava Banerjee - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Folkert Asselbergs - Collaborator - University College London ( UCL )
George Godfrey - Collaborator - Astra Zeneca Ltd - UK Headquarters
Harry Hemingway - Collaborator - University College London ( UCL )
Mehrdad Alizadeh Mizani - Collaborator - University College London ( UCL )
Muhammad (Ashkan) Dashtban - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Suliang Chen - Collaborator - University College London ( UCL )
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tom Lumbers - Collaborator - University College London ( UCL )Outcomes:
 Heart failure
 Diabetes mellitus
 Chronic kidney disease
 Dialysis
 Renal transplant
 Coronary artery disease
 Cardiovascular disease All-cause mortality
 Cardiovascular mortality GP appointments
 Outpatient appointments
 Emergency department attendances
 Diagnostic imaging tests Percutaneous coronary interventions
 Coronary artery bypass graft surgery
 Heart transplant surgery
 Limb amputationDescription: Technical Summary
The project intends to work on complex data to better understand how to define phenotypes and discover sub-phenotypes of three common diseases: heart failure (HF), diabetes mellitus (DM) and chronic kidney disease (CKD). In addition to traditional epidemiologic analyses, unsupervised machine learning approaches such as clustering have been adopted with the intention of recognising disease subtypes. However, those analyses are mostly confined to individual diseases and specific patient sub-groups, which may lead to inaccurate categorisation and consequently inaccurate diagnostics. Furthermore, these three diseases are frequently risk factors for each other, and sometimes co-exist but the Âoverlap syndrome of all three is understudied. Therefore, we aim:
- To study baseline characteristics and outcomes of this overlap syndrome and outcomes, and compare with the individual diseases (HF, DM, and CKD).
- To describe the missed opportunities in guideline recommended care pathway leading to HF and/or CKD diagnosis in DM vs non-DM patients and the patients characteristics along the care pathway.
- To use combined unsupervised and supervised statistical learning to identify sub-phenotypes of HF, DM and CKD.
- To use machine learning (supervised, unsupervised or combined) to identify clusters in the overlap syndromes between HF, DM and CKD
Source -
The use of real-world data to emulate a clinical trial: assessing the impact of temporality, comparator choice and methods of adjustment — Samy Suissa ...
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The use of real-world data to emulate a clinical trial: assessing the impact of temporality, comparator choice and methods of adjustment
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-17
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Devin Abrahami - Collaborator - McGill University
Elodie Baumfeld Andre - Collaborator - Roche
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Peter Honig - Collaborator - Pfizer Inc - US Headquarters
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
This study has two primary outcomes. The effectiveness outcome will be defined as a composite of death from cardiovascular causes, hospital admission for a nonfatal myocardial infarction, or nonfatal stroke (ICD-10 codes listed in Appendix I).
The safety outcome will be defined by a hospital admission for a bile duct- or gallbladder-related condition (e.g., cholelithiasis, cholecystitis, cholangitis, gallstone pancreatitis, and other bile duct, and gallbladder disorders; ICD-10 codes listed in Appendix II).
Description: Technical Summary
Randomized controlled trials are the gold standard for assessing the efficacy and safety of new drugs. However, there are certain situations where conventional two-arm trials are not conducted. This is common in the field of oncology, whereby single-arm trials have been used to investigate the efficacy and safety of new drugs in rare cancers. However, there is growing interest in the use of external controls (i.e., from a different setting) that can be used as comparator arms for such trials. To date, studies that have investigated the utility of external controls have focused on methods to control the confounding that is introduced when using real-world data. However, important knowledge gaps remain, like the temporality of selected controls in relation to the treatment arm, and how to select the control group itself. Thus, using an empirical example among patients with type 2 diabetes, we will investigate whether it is possible to use observational data to emulate results from a clinical trial. Specifically, we will investigate the effectiveness and safety of liraglutide, a second-to-third line treatment in the management of type 2 diabetes. The efficacy and safety of liraglutide was demonstrated in the LEADER trial, which will be used as a point of comparison. Using a cohort of patients with type 2 diabetes, we will emulate the LEADER trial by applying the same inclusion and exclusion criteria, selecting a treated group (i.e., users of liraglutide) and different comparator groups (i.e. users of other antidiabetic drugs). To address existing knowledge gaps in control selection, we will alter the time period for selection of controls, use different control groups and investigate various approaches to deal with confounding. This study will provide guidance on best practices for comparator group selection, which may help inform the design and analysis of randomized controlled trials using external controls.
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Bringing Innovative Research Methods to Clustering Analysis of Multimorbidity (BIRM-CAM) — Sylvia Richardson ...
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Bringing Innovative Research Methods to Clustering Analysis of Multimorbidity (BIRM-CAM)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-20
Organisations:
Sylvia Richardson - Chief Investigator - University of Cambridge
Jessica Barrett - Corresponding Applicant - University of Cambridge
Bemsibom Toh - Collaborator - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Christopher Yau - Collaborator - University of Birmingham
Duncan Edwards - Collaborator - University of Cambridge
Francesca Crowe - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Magdalena Skrybant - Collaborator - University of Birmingham
Paul Kirk - Collaborator - University of Cambridge
Sida Chen - Collaborator - University of Cambridge
Simon Griffin - Collaborator - University of Cambridge
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tom Marshall - Collaborator - University of Birmingham
Yajing Zhu - Collaborator - University of CambridgeOutcomes:
Mortality (ONS death date), acute hospitalisations, polypharmacy, GP consultations with a clinician or nurse, and the development of chronic conditions.
Description: Technical Summary
In this programme, to increase our understanding of multimorbidity (MM), we develop and implement state-of-the-art statistical methods for the analysis of electronic health records data. We will focus on identifying MM clusters and investigating their consequences. We will hold a stakeholder workshop to seek consensus on methods for investigating MM clusters  including lists of conditions to use and clustering approach. As well as critically reviewing existing literature, we will construct new outcome-guided probabilistic clustering techniques to identify cross-sectional and longitudinal patterns of MM associated with clinically relevant outcomes. For the latter, we will produce new time-sequence kernel approaches for grouping sequences of acquired conditions and multi-state models that will additionally model time-to-condition (new comorbidity, hospitalisation or mortality) data. Landmarking approaches will be used to include trajectories of continuous biomarker data within these models to improve their prognostic utility. These methods will serve as the basis of novel clinical prediction tools that can be used to guide decision making. All our methods will be documented and made freely available via a Âmethodological commons that will provide reproducible code notebooks and visualisation of findings in ways that aid clinical interpretation. We will conduct a detailed exploration of longitudinal implications of clusters for polypharmacy and prognosis. The utility of our methods will be validated using a separate national primary care database (The Health Improvement Network, THIN).
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Statins and the development of type-2 diabetes: assessing the benefit-risk ratio for patients with low risk of cardiovascular disease — Nuala Sheehan ...
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Statins and the development of type-2 diabetes: assessing the benefit-risk ratio for patients with low risk of cardiovascular disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-06
Organisations:
Nuala Sheehan - Chief Investigator - University of Leicester
Ellie John - Corresponding Applicant - University of Leicester
Kate Tilling - Collaborator - University of Bristol
Keith Abrams - Collaborator - University of York
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michael Crowther - Collaborator - Karolinska Institute Sweden
Paul Lambert - Collaborator - University of Leicester
Umesh Kadam - Collaborator - University of LeicesterOutcomes:
Incident type 2 diabetes
Secondary outcomes:
 Diabetes risk in patients with major type 2 diabetes risk factors: metabolic syndrome, fasting plasma glucose 100-125 mg/dl, BMI >30 and HbA1c > 6%.
 Cholesterol
 Cardiovascular Disease EventsDescription: Technical Summary
There are concerns that the use of statins can increase patients risk of developing type-2 diabetes. The health problems and complications associated with type 2 diabetes may affect the benefit-risk ratio of prescribing statins to patients with low risk of cardiovascular disease.
A previous study found the risk of developing type 2 diabetes to be 57% (95% CI [54%, 59%]) higher in patients on statins compared to those not on statins. The authors used a propensity score method to adjust for measured confounding. However, their results may still be affected by unmeasured confounding factors.
Instrumental variables methods can be used to obtain causal effect estimates even in the presence of unmeasured confounding provided the assumptions have been satisfied. To investigate potential bias, the previous analysis by Macedo et al. will be extended using instrumental variables, structural equation models and regression discontinuity analysis to obtain unbiased estimates of the effect of statins on the development of type-2 diabetes.
The Cox-proportional hazards model with propensity score adjustment used in the previous study will be replicated on an updated data cut. These will be compared with estimates obtained from an Aalen additive hazards instrumental variables approach. Structural equation model and regression discontinuity approaches will also be applied.
This analysis will form the basis of a simulation study to compare the different methods empirically. The data will be simulated based on features of the study data to ensure that the simulated data are as realistic as possible.
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The prevalence of liver enzyme and function testing in UK primary care — Joanne Morling ...
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The prevalence of liver enzyme and function testing in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-06
Organisations:
Joanne Morling - Chief Investigator - University of Nottingham
Joanne Morling - Corresponding Applicant - University of Nottingham
Joe West - Collaborator - University of Nottingham
Polly Scutt - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of Nottingham
Yusef Alenezi - Collaborator - University of NottinghamOutcomes:
Liver enzymes and function tests (detailed in section N).
Description: Technical Summary
Overall aim:
To understand the temporal changes in individual liver function testing over the period 1997 to most recent in UK general practice in order to inform potential screening practices.Methodology:
We will determine the prevalence of blood marker testing in the adult UK population over time for each of the following assays using CRPD: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), bilirubin, albumin and platelet count. Results will be stratified by subgroups of the population with or at high risk of chronic liver disease: type 2 diabetes, obesity, alcohol excess. We will also determine the frequency of abnormal results.
Annual prevalence rates for each marker will be determined by extracting laboratory measures or READ codes from the linked clinical file to determine their levels.
Subgroups will be determined using validated READ codes.
Temporal trends in marker testing using age and sex standardised rates of each test use will be analysed using a join point regression to look for statistically significant changes in rates of marker testing use over the study period and to determine change points in the trends.Scientific and medical opportunities:
This research will improve the applicability and reliability of clinical guidelines for the diagnosis of CLD in primary care.
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Does the transition from paediatric to adult healthcare lead to increased healthcare usage for young people with a life limiting condition? A quasi-experimental longitudinal cohort study — Stuart Jarvis ...
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Does the transition from paediatric to adult healthcare lead to increased healthcare usage for young people with a life limiting condition? A quasi-experimental longitudinal cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-09
Organisations:
Stuart Jarvis - Chief Investigator - University of York
Stuart Jarvis - Corresponding Applicant - University of York
Catherine Hewitt - Collaborator - University of York
Lorna K Fraser - Collaborator - University of YorkOutcomes:
Numbers, per person year, of GP consultations, emergency and planned inpatient admissions and A&E visits
- Regularity of GP appointments (measured by coefficient of variation: standard deviation of gaps between appointments divided by mean gap between visits)
- Consistency of GP seen (measured by usual provider of care index: share of visits that are with the most commonly seen GP)Description: Technical Summary
Life limiting conditions (LLC) are becoming increasingly prevalent among children and young people. Currently children with a LLC receive specialist paediatric care before transitioning to adult services (typically from 16 years of age onwards) coordinated by a GP. Increasing life-spans mean that this is an increasingly common occurrence. Problems around transition have been recognised, but there is a lack of quantitative research on healthcare use and associated costs.
This study involves quantitative secondary data analyses of routinely collected healthcare data (all individuals aged up to age 23 years in CPRD GOLD with linked HES data) to:
1. determine, using quasi-experimental methods (interrupted time series, difference in difference, regression discontinuity), the extent of any change in GP consultations, emergency and planned inpatient admissions and Accident and Emergency (A&E) attendances among young people with LLC transitioning from paediatric to adult care and compare these changes to those observed for children with non-life-limiting chronic conditions and without chronic conditions at the same ages.
2. determine how changes in emergency care at the transition relate to frequency or regularity/consistency of GP consultations before, during and after the transition, using multilevel regressions from the Poisson family and what demographic factors influence this GP contact.
3. estimate the costs associated with changes in emergency and GP care after the transition compared to before the transition and to changes for the non-life-limiting chronic conditions and without chronic conditions groups.
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The relative vaccine effectiveness of current and emerging influenza vaccines in people aged 65 years and above: a nationwide cohort study — Jonathan Van...
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The relative vaccine effectiveness of current and emerging influenza vaccines in people aged 65 years and above: a nationwide cohort study
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-04
Organisations:
Jonathan Van-Tam - Chief Investigator - University of Nottingham
Louise Lansbury - Corresponding Applicant - University of Nottingham
Heather Whitaker - Collaborator - Public Health England
Nick Andrews - Collaborator - Public Health England
Richard Pebody - Collaborator - Public Health England
Tricia McKeever - Collaborator - University of Nottingham
Wei Shen Lim - Collaborator - Nottingham University HospitalsOutcomes:
Preliminary:
For the first influenza season we will conduct a preliminary exploration of the data in CPRD Gold and describe the study population receiving the different vaccines types in terms of age, gender, co-morbidities, socio-economic status, geographical location and timing of vaccination according to these factors.Primary:
GP medically-attended influenza-like illness or influenza (clinically diagnosed)Secondary:
Influenza-related hospital admissions, listing an International Classification of Diseases Tenth Revision, Clinical Modification, code for influenza (Codes J09.xx, J10.xx, J11.xx, and J129) (see appendix for codes);Influenza-related Intensive Care Unit admissions
Timing of outcomes: from 14 days after receipt of influenza vaccination to the end of the influenza season each year. The influenza season will be defined by Public Health EnglandÂs virological surveillance data. Using the Moving Epidemic Method (MEM)(1) to define baseline thresholds, the start of the influenza seasons will be defined when the virological surveillance indicates that the weekly positivity rate of samples reaches the baseline threshold. The end of the influenza season will be defined by when the data indicate the weekly positivity rates of samples returns below the baseline threshold, plus 14 days.
Description: Technical Summary
Objective
To estimate the relative vaccine effectiveness (RVE) of influenza vaccines licensed in adults aged 65 and above during a given influenza season.Study design
Primary-care based cohort study using data from CPRD Aurum/GOLD and HES.Methods
Specific codes in the CPRD GOLD/Aurum medical dictionary will be used to collect information on types of influenza vaccine administered. Adults 65 and above vaccinated during the influenza seasons of interest with one of the currently recommended influenza vaccines (e.g. adjuvanted trivalent, cell-grown quadrivalent) will be included. Additionally, we will explore the effect on patient numbers of including people aged 60-64 who may have received one of the vaccines of interest. CPRD Aurum will be used to determine GP consultations for influenza-like illness and clinically-diagnosed influenza in people receiving the vaccines of interest each season. HES data will be used to determine influenza-related hospitalisations and intensive-care admissions. Individuals will be considered vaccinated 14 days or more after receipt of influenza vaccine, and will be followed up until one of the following: outcome of interest, end of study period, death, subsequent influenza vaccination within the same influenza season.We anticipate requiring data for three influenza seasons to adequately power the study (2019-2020, 2020-2021, 2021-2022). We believe adjuvanted vaccine will be predominant during the 2019-2020 season and that vaccine batch numbers will unavailable in Aurum during that season, so we will use CPRD GOLD at the end of the 2019-2020 season to assess data quality and describe the study population, informing CPRD Aurum analyses in subsequent seasons.
Data analysis
If there is no apparent bias in the study population in the type of vaccination given, we will conduct multi-variable Poisson regression analyses. Adjusted RVE will be defined as (1-rate ratio) x100%. Subgroup analysis of people 75 and above and 85 and above will be performed.
Source - and 19 more projects — click to show
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Developing risk prediction models to support individualised HbA1c target setting using routinely collected primary and secondary care data from the United Kingdom (UK) — Iskandar Idris ...
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Developing risk prediction models to support individualised HbA1c target setting using routinely collected primary and secondary care data from the United Kingdom (UK)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-20
Organisations:
Iskandar Idris - Chief Investigator - University of Nottingham
Jason Gordon - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Nadeem Qureshi - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Clinical outcomes:
The following clinical outcomes will be derived based on the earliest recording of the relevant diagnosis in either CRPD GOLD or HES APC using READ and ICD-10 codes respectively:
 an occurrence of hypoglycaemia, defined as a composite outcome of the first recording of any of:
an occurrence of microvascular complications, i.e. diabetic nephropathy, diabetic neuropathy, retinopathy
 an occurrence of macrovascular complications, i.e. congestive cardiac failure, ischaemic heart disease, myocardial infarction, stroke; any admission to hospital;
 death.
In cases where there are multiple records of an event across the combined data, the earliest record of an event (such as a myocardial infarction (MI)) will represent the index event, with other records defined as representing the same event (MI) if they were dated within 30 days of the index event (MI)).
Health and economic outcomes
The health and economic consequences associated with HbA1c target setting will be based on regression analysis of rates of clinical events and hospitalisations the event rate profiles estimated from the developed risk equations relating these outcomes to patient-level characteristics and HbA1c levels:
 Event rates: micro- and macrovascular, hypoglycaemia, death;
 Event costs: event costs in first and subsequent years, based on published sources;
 Life expectancy: derived from life tables;
 Quality -adjusted life expectancy: age, gender and event-based disutility profiles will be applied to life expectancy profiles.Description: Technical Summary
A retrospective database study of routinely collected UK primary and secondary care data will inform the development of predictive models (risk equations) relating the risk of T2DM-related events to patient profiles.
Data from the CPRD GOLD dataset in addition to linked hospital episode statistics (HES) admitted patient care (APC) will be extracted for all T2DM patients over the study period 01/01/1998Â31/12/2017 based on a 5-year pre-index look back period and a 15-year post-index period.
Patient data will follow all observations up to and including the first occurrence of death, loss to follow up, or the end of the index period (31/12/2017).
Study outcomes include an individual occurrence of:
a) microvascular complications;
b) macrovascular complications;
c) hypoglycaemia;
d) admission to hospital;
e) death.Explanatory variables will include factors relating to patients:
a) Demographic profile
b) Socioeconomic profile
c) Clinical profileMultivariate regression equations relating outcome risk to patient profiles will be used to generate risk profiles for alternative HbA1c targets. Models will be developed concurrently based both on a single timepoint (i.e. baseline) and across multiple timepoints to consider not only the hazard at a single time-point but also how that hazard changes as a factor of time-varying factors (such as the effect of age, body mass index, etc.)
Within the model development process, any models developed will be assessed to understand the generalizability related to our dataset and model performance in relation to existing research. Assessments between the two models in relation to predicting complications will be compared utilizing receiver-operating characteristic (ROC) curves to determine generalizability and applicability.
The health economic consequences associated with an individualized approach to HbA1c target setting will be explored via analyses relating hospitalization and clinical events to HbA1c levels after adjusting for a range of patient characteristics.
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Risk factors in prosthetic joint replacement infections — Polina Prokopovich ...
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Risk factors in prosthetic joint replacement infections
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-09
Organisations:
Polina Prokopovich - Chief Investigator - Cardiff University
Polina Prokopovich - Corresponding Applicant - Cardiff University
Bismah Bojan - Collaborator - Cardiff University
Hywel M. Jones - Collaborator - Cardiff University
Stefano Perni - Collaborator - Cardiff University
Stephen Austin Jones - Collaborator - Cardiff and Vale University Health BoardOutcomes:
 PJI offsets count
 Amputations performed due to PJI
 Debridement Surgeries performed due to PJI
 Revision Surgeries performed due to PJI
 Length of stay in hospital due to PJI
 Deaths caused by PJI
 Hospitalisations for PJI with admission through A&Eto be included in "Planned use of linked data and benefit to patients in England and Wales":
The results of this CPRD analysis will inform health authorities (i.e. NHS and Trusts) about the risk profile and risk factors for PJI of patients in England and Wales undergoing hip or knee replacement along with the potential impact of surgical procedures enacted in the country. This increase in knowledge about underlying risks to PJI, specific to England and Wales, may provide reasons to update local guidelines and initiate active monitoring of patients at high risk of PJI in order to anticipate/prevent the infection offset.No HES-A&E linkage is required as the analysis proposed will only need the source of the hospitalisation (admimeth coded in the HES-hospitalisations table available from HES-APC that has already been approved).
Description: Technical Summary
The main objective of this retrospective cohort study is to utilise the Clinical Practice Research Datalink (CPRD) and linked Hospital Episode Statistics (HES) and Office of National Statistics (ONS) to identify risk factors that predict PJI incidence and associated outcomes (i.e. debridement, revision surgery, amputation or death) and develop risk predication equations for each of them.
Recently published real-world studies have largely examined associations between patients characteristics and clinical PJI incidence in relatively narrowly-defined patient populations. However, there is a relative scarcity of studies that elucidate risk factors for PJI patient outcomes.
Univariate and multivariate methods of statistical analysis will be used to identify risk factors that predict PJI and summary descriptive statistics will be generated characterising patient demographics, clinical and treatment characteristics and health resources use in relation to stratification of risk, incidence and outcomes of PJI.
The resulting set of risk equations will be reflective of current UK patients and practices and will provide real word evidence to clinical and policy decision making.
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Healthcare resource utilisation attributable to Distal Renal Tubular Acidosis in adult and paediatric population in the UK: A matched group retrospective study — FLORENT Guelfucci ...
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Healthcare resource utilisation attributable to Distal Renal Tubular Acidosis in adult and paediatric population in the UK: A matched group retrospective study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-20
Organisations:
FLORENT Guelfucci - Chief Investigator - Syneos Health Commercial France SARL
FLORENT Guelfucci - Corresponding Applicant - Syneos Health Commercial France SARL
Catherine Martre - Collaborator - Advicenne
David Game - Collaborator - Guy's & St Thomas' NHS Foundation Trust
Florence Bianic - Collaborator - Syneos Health ( inVentiv Health Clinical )Outcomes:
Primary outcomes:
 Healthcare resource use attributable to dRTA:
o Incidence rate ratio of/difference in number of inpatient admissions (for all causes), A&E attendances (for all causes), hospital outpatient visits (for all causes), GP attendances/nursing interactions, referrals, medications between patients with dRTA and patients without dRTA;
o Difference in length of stays between patients with dRTA and patients without dRTA;
o Attributable risk (hazard ratio) of occurrence of inpatient admissions (for all causes), accident & emergency attendances (for all causes), hospital outpatient visits (for all causes), referrals between patients with dRTA and patients without dRTA;
Secondary outcomes:
 Healthcare resource use in each group:
o Number of inpatient admissions, hospital outpatient visits, A&E attendances, GP attendances/nursing interactions, referrals, medications;
o Incidence rate of inpatient admissions, hospital outpatient visits, A&E attendances, referrals;
 Attributable risk (hazard ratio) of mortality [all-causes], risk of specific cause-related hospitalisation, by specific cause: renal & osteoskeletal conditions, kidney stones, hearing problems, hyperkalaemia/hypokalaemia attributable to dRTA (vs. patients without dRTA);
 Patient Demographics (e.g. age, sex, Charlson Comorbidity Index [or an alternative comorbidity index], polypharmacy, follow-up duration, underlying conditions including Sjögren syndrome, systemic lupus erythematosus, sickle cell anaemia, chronic obstructive uropathy, or post-renal transplantation...)Description: Technical Summary
This study is a non-interventional retrospective study evaluating the healthcare resource utilisation and clinical outcomes of patients with diagnosed or suspected dRTA in the United Kingdom, using the Clinical Practice Research Datalink (CPRD) GOLD and Hospital Episode Statistics (HES) databases.
The primary analyses will consist in estimating the difference in healthcare resource utilisation (HCRU) between patients with dRTA and patients without dTRA, over the past 10 years [1 January 2010 Â 31 December 2020], overall, in adult and in paediatric patients. Healthcare resource categories of interest will be hospital admissions (number and length of stays), outpatient hospital visits, referrals, GP attendances/nursing interactions, accident & emergency (A&E) attendances and medication
Unadjusted and adjusted incidence rate ratios and mean differences in number of HCRU events will be estimated using adjusted negative binomial regression models. Unadjusted and adjusted attributable risk of HCRU events will be estimated using Cox proportional hazards regression models.
In order to eliminate the impact of confounding parameters, patients without dRTA will be defined and selected using a matching process to ensure a balanced comparison between the two cohorts. A propensity score matching is anticipated but other methods will be also considered.
Secondary objectives will consist of describing and comparing health care utilisation, risk of death and risk of hospitalisations due to specific causes, i.e. renal conditions, hearing difficulties, osteoskeletal conditions, kidney stones and hypokalaemia/hyperkalaemia, between patients with dRTA and matched patients without dRTA, considering the whole patients follow-up in CPRD data.
With these comparisons, the researchers hope to quantify the incremental economic and complication burden that dRTA poses to the English NHS.
Source -
Assessment of production batch information of vaccines in the Clinical Practice Research Datalink — Francois Haguinet ...
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Assessment of production batch information of vaccines in the Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-13
Organisations:
Francois Haguinet - Chief Investigator - GSK Vaccines
Francois Haguinet - Corresponding Applicant - GSK Vaccines
Corinne Willame - Collaborator - GlaxoSmithKline - UK
Emmanuel ARIS - Collaborator - GSK
Olivia Mahaux - Collaborator - GlaxoSmithKline - UK
Vincent Bauchau - Collaborator - UCB Pharma SA - UKOutcomes:
Immunisation with GSK vaccines; Immunisation with Rotarix
Description: Technical Summary
The aim of this study was to assess the quality of batch numbers of vaccines recorded in the CPRD.
The quality of the vaccines batch identifiers (BID) recorded in CPRD in 2015 was evaluated for GSK vaccines including Infanrix, Rotarix, Priorix, Menitorix, Boostrix, Nimenrix, Engerix-B, Twinrix/Ambirix, Fluarix QIV, Havrix and others less represented. The analysis matched the valid BID issued by GSK for the vaccine shipments to the UK, as available from the GSK GIO database, to BID recorded in CPRD.
In a first step, we assessed the quality of the GSK vaccines BIDs recorded in the CPRD database based on the GSK GIO database. Each GSK vaccine product/brand contains a specific four characters prefix in its BID. We computed the proportion of vaccines BIDs recorded in the CPRD that were fully matched to GSK vaccines BIDS among those presenting GSK-specific prefixes.
In a second step, we computed the sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive values (NPV) for the detection of Rotarix vaccinations through BIDs, considering Rotarix vaccinations detected through medcodes and immstype as the reference. This evaluation was conducted from 01-Jul-2013, date of the introduction of Rotarix in the UK National Immunization Programme, until 31-Dec-2015. During this period Rotarix was the only rotavirus vaccine used in UK.
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Long-term survival following invasive pneumococcal disease: a case-cohort study — Helen McDonald ...
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Long-term survival following invasive pneumococcal disease: a case-cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-09
Organisations:
Helen McDonald - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Grint - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health England
Shamez Ladhani - Collaborator - Public Health England
Zahin Amin-Chowdhury - Collaborator - Public Health EnglandOutcomes:
Death from any cause
Description: Technical Summary
Cohort studies have found that 5-10 year mortality is high among survivors of invasive pneumococcal disease. However, previous studies have not adjusted for pre-existing comorbidities, which could explain this finding.
This study will compare survival among an anonymised Public Health England dataset of 6000 individuals aged 65 years or over with laboratory-confirmed invasive pneumococcal disease from 1 January 2012 to 31 December 2016, to a control cohort drawn from CPRD of members of the general population aged 65 years or over. The control cohort will be individuals aged 65 years or over and active in the Clinical Practice Research Database 2012-2016. The two datasets will not be linked, and both datasets will remain fully anonymised.
The study will use a case-cohort design to compare long-term survival among cases (from 120 days after infection onset to latest mortality data linkage for end of follow up) to long-term survival among the control cohort, using multivariable Cox or Poisson regression models to adjust for age, sex, deprivation, ethnicity and co-morbidities.
This will enable better understanding of the long-term prognosis of IPD and inform improved estimates of the benefits and cost-effectiveness of pneumococcal vaccination.
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Lung function decline and rate of cardiovascular disease in COPD patients in England — Jennifer Quint ...
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Lung function decline and rate of cardiovascular disease in COPD patients in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-18
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College London
Debbie Jarvis - Collaborator - Imperial College London
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
Rate of incident cardiovascular disease including: stroke, heart failure (HF), myocardial infarction (MI), angina, atrial fibrillation (AF), and ischemic heart disease (IHD). We will include these CVD subtypes in order to pick up the whole spectrum of CVD.
Our outcome will primarily be a composite CVD variable (which includes HF, MI, stroke, angina, AF, IHD) and secondary outcomes will consist of HF, MI, stroke, angina, AF, and IHD individually.
Description: Technical Summary
People with chronic obstructive pulmonary disease (COPD) have a faster lung function decline compared to the general population. Accelerated lung function decline has been associated with mortality, and more recently with cardiovascular disease (CVD) in the general population. Specifically, accelerated lung function decline was associated with incident heart failure, stroke, death, and hospitalisations from heart failure. CVD is a common comorbidity of COPD and thus it is important to understand how lung function decline influences risk of incident cardiovascular disease in a population of COPD patients. Using survival analyses we will investigate rate of incident CVD in relation to rapid lung function decline over a 15 year period in a primary care population of COPD patients.
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Characterization of mild, moderate and severe asthma patients based on the GINA guidelines in the UK CPRD database — Raymond Przybysz ...
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Characterization of mild, moderate and severe asthma patients based on the GINA guidelines in the UK CPRD database
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-06
Organisations:
Raymond Przybysz - Chief Investigator - NOVARTIS
- Corresponding Applicant -
Abheenava Kumar - Collaborator - Novartis Pharma AG
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ngew Kok Yew - Collaborator - NOVARTIS
Tay Hao Zhe - Collaborator - Novartis Corporation (Malaysia) Sdn. Bhd.Outcomes:
Global initiative for asthma severity step; asthma exacerbation; treatment failure; blood eosinophils; healthcare resource utilisation
Description: Technical Summary
The proposed study is a retrospective, non-interventional analysis of the Clinical Practice Research Datalink (CPRD), the Hospital Episode Statistics (HES) admitted patient care, HES accident and emergency, HES outpatient and Official for National Statistics (ONS) mortality datasets. There will be linkage between the CPRD and HES data for patients who have records in both. The study aims to characterise a population with asthma by severity status defined by the Global Initiative for Asthma (GINA) guidelines. GINA classifies patients by the therapeutic regimen required to minimise symptoms and prevent exacerbations. Patients with a diagnosis of asthma recorded using the Read code classification in CPRD GOLD or ICD-10 in the HES datasets period 2012-2017 will be extracted. Two cohorts will be selected for each year of the study period (2012 to 2017); a cross-sectional cohort (cohort A) and a longitudinal cohort (cohort B). For cohort A, index date will be 1st of January of each of the calendar years. For incident patients it will be the first-ever asthma diagnosis. For cohort B, index date will be the start of a first treatment regimen for each GINA step 2 to 5 within the identification period The primary objective is to estimate the proportion of prevalent or newly diagnosed paediatric, adolescent and adult cases classified as mild, moderate and severe by GINA step 2 to 5 and by level of blood eosinophils. Secondary objectives are to stratify the population by GINA step and describe the demographic characteristics, clinical characteristics, the proportion of patients with controlled and uncontrolled asthma and all-cause and asthma specific healthcare resource utilisation. In addition, we wish to characterise duration of therapy within each GINA step. As the study is descriptive, no statistical tests will be performed.
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Sickle Cell Anaemia and risk of cardiovascular disease: a UK population study — Victoria Welsh ...
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Sickle Cell Anaemia and risk of cardiovascular disease: a UK population study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-02
Organisations:
Victoria Welsh - Chief Investigator - Keele University
Victoria Welsh - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Chun Shing Kwok - Collaborator - Keele University
Ismail Yahaya - Collaborator - Keele University
Olalekan Uthman - Collaborator - University of Warwick
Ram Bajpai - Collaborator - Keele University
Sara Muller - Collaborator - Keele University
Toby Helliwell - Collaborator - Keele UniversityOutcomes:
Rate (all events) of coronary artery disease; rate (all events) of angina; rate (all events) of acute coronary syndrome; rate (all events) of myocardial infarction.
Description: Technical Summary
Sickle cell disease (SCD), an inherited haemoglobinopathy, is associated with significant morbidity and mortality. Access to established management regimes mean that adults with SCD are living longer. The effects of increased exposure to the cumulative effects of SCD are generally well documented, for example retinopathy, renal disease, and pulmonary hypertension. However, the prevalence of coronary artery syndrome (including coronary artery disease, angina, and acute coronary syndrome) and myocardial infarction amongst adults with SCD is unreported despite potential common patho-physiological pathways. This knowledge gap will be addressed using a retrospective matched cohort study to describe the rate of coronary artery disease (angina and acute coronary syndrome) and myocardial infarction in a UK-based population of adults with sickle cell disease. The exposed population, defined as adults aged 18 years and older with a CPRD code pertaining to a diagnosis of SCD, will be matched for year of birth, sex, general practice and ethnicity to adults without a CPRD-coded diagnosis of SCD. Measured outcomes are event rates of coronary artery syndrome and myocardial infarction as determined through relevant codes in CPRD, Hospital Episode Statistics (HES) data and ONS Mortality data. Modelling rate of events through Poisson regression will be used to investigate the hypothesis that the rate of coronary artery syndrome and myocardial infarction is higher in adults with SCD compared to matched individuals without SCD. Prevalence and prevalence differences for each risk factor will be calculated to explore the hypothesis that traditional risk factors for coronary artery syndrome and myocardial infarction are more prevalent in adults with SCD than in matched individuals without SCD. The results will guide future research to ultimately develop cardiovascular preventative programmes for adults with SCD globally.
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Contemporary epidemiology of coeliac disease, dermatitis herpetiformis, CrohnÂs disease and ulcerative colitis in the United Kingdom — Laila Tata ...
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Contemporary epidemiology of coeliac disease, dermatitis herpetiformis, CrohnÂs disease and ulcerative colitis in the United Kingdom
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-05
Organisations:
Laila Tata - Chief Investigator - University of Nottingham
Laila Tata - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Joe West - Collaborator - University of Nottingham
Mariam Ratna - Collaborator - University of Nottingham
Timothy Card - Collaborator - University of Nottingham
Yue Huang - Collaborator - University of Nottingham
Yvonne Nartey - Collaborator - University of NottinghamOutcomes:
coeliac disease, dermatitis herpetiformis, irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) which includes CrohnÂs disease, ulcerative colitis, and unclassified IBD
Description: Technical Summary
Aims of the project
We will provide contemporary estimates of the diagnoses of coeliac disease, dermatitis herpetiformis, CrohnÂs disease and ulcerative colitis in the United Kingdom (UK). We will determine incidence and prevalence of each condition and describe how they vary by age, gender, ethnicity, socioeconomic position and area of residence. We will assess potential prior misdiagnosis as irritable bowel syndrome (IBS).Why this research is needed
It is highly likely that coeliac disease remains underdiagnosed in the UK. We have no UK-wide figures for CrohnÂs disease or ulcerative colitis diagnoses, so we do not know the potential for under-diagnosis or whether certain population groups are affected differently.
Our research will inform clinicians and policy makers of the occurrence of disease for the purposes of health care planning and will show potential areas for improvements in diagnosis that could be achieved. Quantifying the burden upon healthcare systems and society in general will have an impact on individuals affected by these conditions now and in the future as it could help to improve awareness, diagnosis and treatment. Understanding whether IBS misdiagnosis is continuing could help designing clinical diagnostic pathways to improve investigations for patients with gastrointestinal symptoms.Design and methodology
We will design a population-based study using all longitudinal patient healthcare records from the Clinical Practice Research Datalink (CPRD). We will calculate incidence and prevalence of each condition from 2000-2019 and the number of prior IBS diagnoses. Poisson regression will be used for incidence time trends and stratifying estimates by sociodemographic characteristics. Hospital Episode Statistics is required to maximise information on peopleÂs diagnoses and ethnicity. Patient and practice level Index of Multiple Deprivation and practice level urban-rural classification are required to characterise the distribution of diagnoses as a first step to understanding where and how diagnosis rates may be optimised.
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Stage at diagnosis and subsequent health care provision for patients with alcoholic liver disease and the association with their socioeconomic status — Colin Crooks ...
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Stage at diagnosis and subsequent health care provision for patients with alcoholic liver disease and the association with their socioeconomic status
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-18
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Gro Askgaard - Corresponding Applicant - Aarhus University Hospital
Anna Emilie Kann - Collaborator - Aarhus University Hospital
Harmony Otete - Collaborator - University Of Central Lancashire
Joanne Morling - Collaborator - University of Nottingham
Joe West - Collaborator - University of Nottingham
Kate Fleming - Collaborator - University of Liverpool
Peter Jepsen - Collaborator - Aarhus University Hospital
Timothy Card - Collaborator - University of NottinghamOutcomes:
 Odds ratios for advanced disease stage at diagnosis of alcoholic liver disease according to socioeconomic status.
 Survival time and cause-specific mortality according to disease stage at diagnosis of alcoholic liver disease and socioeconomic status.
 Estimate incidence rates of health care (primary care visits, acute admissions associated to liver disease, upper endoscopy, diagnostic imaging, and specialist care) according to socioeconomic status.
 Risk estimates for mortality among patients with alcoholic liver cirrhosis according to socioeconomic status, psychiatric comorbidity, and stratified by disease stage and adjusted for health care, comorbidity, and life-style factors.Description: Technical Summary
Alcoholic liver disease is a life-threatening condition causing a large fraction of all alcohol-related deaths. In several countries including the UK, people of high socioeconomic status consume just as much alcohol as people of lower socioeconomic status, yet alcohol causes more death and disease in the latter.
We will combine data from registers of primary care contacts, hospital episode statistics, diagnostic imaging, cause of death, and individual socioeconomic status measured as patient-level deprivation index. We will investigate if a more advanced disease stage at diagnosis or/and differences in health care can explain the increased mortality from alcoholic liver disease associated with low socioeconomic status.
We will compare the risk of an advanced disease stage at diagnosis with alcoholic liver disease according to socioeconomic status, controlling for confounding from comorbidity and lifestyle factors. We will compute all-cause and cause-specific mortality rates according to disease stage and socioeconomic status at diagnosis with alcoholic liver disease.
Among patients with advanced alcoholic liver disease, we will assess rates of health care (primary care visits, planned/unplanned hospital care, and diagnostic testing associated with liver disease) according to socioeconomic status. We will then examine whether the higher mortality in patients with low compared to high socioeconomic position can be partly explained by differences in health care, lifestyle factors, and/or comorbidity, including psychiatric comorbidity.
Information provided from these studies should help us design preventive interventions for alcoholic liver disease in groups of lower socioeconomic status. For example, population screening could target people of lower socioeconomic status if our research shows that such people tend to be diagnosed in a later disease stage. Our results on differences in health care after diagnosis of alcoholic liver disease may reveal whether we need stronger efforts to promote health care among groups of lower socioeconomic status.
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Cardiovascular Risk Profiles: Comparing the Glucagon-Like Peptide-1 Receptor Agonist Cardiovascular Outcomes Trials REWIND, LEADER and SUSTAIN-6 in a Real World Population with Type 2 Diabetes in UK Primary Care — Jonathan Rachman ...
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Cardiovascular Risk Profiles: Comparing the Glucagon-Like Peptide-1 Receptor Agonist Cardiovascular Outcomes Trials REWIND, LEADER and SUSTAIN-6 in a Real World Population with Type 2 Diabetes in UK Primary Care
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-18
Organisations:
Jonathan Rachman - Chief Investigator - Eli Lilly & Co - UK
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Antje Hottgenroth - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Christina Diomatari - Collaborator - Adelphi Real World
Iskandar Idris - Collaborator - University of Nottingham
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Julie Mount - Collaborator - Eli Lilly & Co - UK
Lill-Brith von Arx - Collaborator - Eli Lilly & Co - UK
Olivia Massey - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Primary outcome:
 Counts and proportion of T2D patients in the UK primary care who meet the CV criteria for each of the following CVOTs:
o REWIND (n, %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)Secondary outcomes:
 Counts and proportion of T2D patients in the UK primary care who meet the core criteria (CV profile, age, BMI, HbA1c and eGFR, medication history) for each of the following CVOTs:
o REWIND (n. %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)Â Descriptive statistics (n, %, mean, SD) of clinical and demographic characteristics of T2D patients in the UK primary care:
o Age (years) : mean, SD
o Gender (cat: male/female): n, %
o HbA1c (%): mean, SD
o eGFR (ml/min/1.73m2): mean, SD
o eGFR (ml/min/1.73m2)
? <60 (n, %)
? >=60 (n, %)
o Disease duration (years): mean, SDExploratory outcomes:
 Counts and proportion of patients with T2D in UK primary care who meet the applicable Âestablished CV disease criteria for each of the following CVOTs:
o REWIND (n. %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)
 Counts and proportion of patients with T2D in UK primary care who meet the applicable ÂCV risk factors criteria for each of the following CVOTs:
o REWIND (n. %)
o LEADER (n, %)
o SUSTAIN-6 (n, %)Description: Technical Summary
The aim of the study is to determine the extent to which patients with T2D enrolled into the REWIND, LEADER and SUSTAIN-6 Cardiovascular Outcome Trials (CVOTs) are representative, from a CV profile perspective, of T2D patients in UK routine clinical practice. A cross-section of adult patients with a diagnostic code indicative of T2D or treatment history with at least 2 classes of glucose lowering medications will be selected in CPRD at a single point of time, and those eligible for linkage with HES Admitted Patient Care records will form the analytical cohort.
A combination of Read Codes, ICD and procedural codes, or laboratory test results will be applied in the linked HES-CPRD dataset to determine the CV criteria for each of the REWIND, LEADER and SUSTAIN-6 CVOTs. Counts and proportion of T2D patients included in the linked CPRD-HES database who match the CV profile of participants in REWIND, LEADER and SUSTAIN-6 will be estimated. This study will generate evidence about the representativeness of each CVOT for the UK population with T2D and therefore the extent of the generalisability of their results to the UK T2D population.
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External validation study investigating the association between hormonal contraceptives and asthma onset in females of reproductive age — Aziz Sheikh ...
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External validation study investigating the association between hormonal contraceptives and asthma onset in females of reproductive age
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-17
Organisations:
Aziz Sheikh - Chief Investigator - University of Edinburgh
Syed Ahmar Shah - Corresponding Applicant - University of Edinburgh
Bright Nwaru - Collaborator - University of GothenburgOutcomes:
New-onset asthma is our key outcome of interest. New-onset asthma will be defined as the first General Practitioner (GP)-recorded asthma event (including diagnosis, hospitalisation, medication prescription or any other asthma event) occurring at least 5 years from the start of the follow-up date. We will exclude individuals with a relevant asthma event recorded up to 5 years after the start of follow-up date. We assume that within a 5-year period, a patient with asthma should have had at least one clinical encounter.
Description: Technical Summary
Female sex steroid hormones have been implicated in sex-related differences in the development of asthma. The role of exogenous sex steroids, however, remains unclear. Our recent systematic review highlighted the lack of high-quality population-based studies investigating this subject. We aim to investigate whether the use of hormonal contraception subtypes and route of administration are associated with asthma onset in reproductive age females. Using CPRD, a national primary care database in the UK, we will construct a retrospective open longitudinal cohort of reproductive age (16Â45 years) females. We will estimate the risk of new-onset asthma using Cox regression. We will adjust for confounding factors in all analyses. We will evaluate interactions between the use of hormonal contraceptives and body mass index (BMI) and smoking by calculating the relative excess risk due to interaction and the attributable proportion due to interaction.
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Colorectal cancer survivorship & the development of kidney diseases — Krishnan Bhaskaran ...
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Colorectal cancer survivorship & the development of kidney diseases
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-20
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kirsty Andresen - Corresponding Applicant - OXON Epidemiology - Spain
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Acute Kidney injury; Chronic kidney disease; End stage renal disease (ESRD)
Description: Technical Summary
Colorectal cancer and kidney conditions (such as acute kidney injury [AKI] & chronic kidney disease [CKD]) are common in older people. There is currently little evidence on the relationship between colorectal cancer and kidney disease. It is thought that colorectal cancer treatments that could cause damage to the kidneys (such as ileostomies or nephrotoxic chemotherapy drugs) and/or shared risk factors could affect kidney function in those with colorectal cancer. It is important to understand the relationship between colorectal cancer and kidney conditions considering the high burden of morbidity, mortality and costs associated with the management of kidney conditions, the increasing survival rate of colorectal cancer and the aging population in the UK.
Our study will compare the baseline prevalence of kidney conditions in colorectal cancer patients to matched controls from the general population. We will then compare rates of incident kidney disease after colorectal cancer diagnoses between people with and without colorectal cancer. We will also assess whether the association between colorectal cancer and kidney disease changes with the number of years the individual has survived colorectal cancer or with other individual-level factors.
We will conduct a historical comparative matched cohort study where individuals over 18 with a diagnosis of colorectal cancer during the study period (earliest available HES data until the latest available CPRD data) will be individually matched, 1:5, with individuals registered with practices in CPRD with no history of any cancer. Hazard ratios will be calculated using CoxÂs proportional hazards models to compare the rates of kidney disease between individuals with colorectal cancer and the matched cohort.
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Primary Care Treatment Pathways in ParkinsonÂs Disease in the UK — Adrian Paul J. Rabe ...
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Primary Care Treatment Pathways in ParkinsonÂs Disease in the UK
Datasets:GP data, ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-04
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
Demographic characteristics (age, sex, total time in cohort, total follow-up time); treatment pathway (number of lines of therapy, number patients reaching each line of therapy, number of patients in each regimen within each line of therapy); prescription length (time from start to end of prescription)
Description: Technical Summary
PD is a movement disorder marked by the loss of dopaminergic neurons. These neurons mediate movement and contribute to coordination, balance, and fine motor control. The loss of these neurons cause patients to lose such functions, leading to increased falls, tremors at rest, automatic coordination, and even speech and writing issues. The result is a significant impairment in activities of daily living and occupation, and decreased quality of life.
PD tends to appear in the older age group, when the progressive loss of dopaminergic neurons manifests symptoms. Thus, in countries with aging populations such as the UK, there is an increased prevalence of PD. The management of PD is complex and requires navigating through the different medication options available. While speciality care is needed in the diagnosis and initial management of PD patients, including shepherding patients through medication regimens, shifting them and adjusting doses in order to achieve the best possible control of symptoms while avoiding side effects, GPs have been given the responsibility to continue care for PD patients in primary care. As with many conditions, the guidelines for PD are complex and frequently updated, leaving GPs with the burden of updating themselves whenever the newest principles of management are changed.
This study aims to map the treatment pathway of patients in primary care based on the medications prescribed to them by GPs. We will be using a retrospective descriptive single cohort study design implemented on a clinical dataset for primary care from CPRD. The primary outcome of this study would be a distribution of patients across different treatments used in each line of therapy for PD. No comparisons will be made. Patient counts and percentages shall be reported.
With this study, we will be able to verify compliance with clinical practice guidelines, and employ interventions in primary care to address shortfalls in the treatment pathway.
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Risk of skin cancer associated with use of thiazides and thiazide-like diuretics: a cohort study — Susan Jick ...
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Risk of skin cancer associated with use of thiazides and thiazide-like diuretics: a cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-20
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Daphne Reinau - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Julia Spoendlin - Collaborator - University of Basel
Rahel Schneider - Collaborator - University Hospital Basel
Seline Stoffel - Collaborator - University Hospital BaselOutcomes:
Diagnosis (recorded as Read codes) of:
- CMM and/or
- NMSC (specifically BCC or SCC) in the CPRDDescription: Technical Summary
Exposure to thiazides and thiazide-like diuretics (TZs), known as photosensitizing agents, has recently been associated with an increased risk of cutaneous malignant melanoma (CMM) and nonmelanoma skin cancer (NMSC; in particular of basal cell carcinoma [BCC] and cutaneous squamous cell carcinoma [SCC]). However, data on this potential association are not only limited but also inconsistent.
We will conduct a cohort study to estimate the absolute and relative risks of CMM, BCC, and SCC in TZs users compared with patients taking a) calcium channel blockers (CCBs) and separately b) renin-angiotensin-aldosterone system inhibitors (RAASi), two other classes of first-line antihypertensive drugs.
We will estimate incidence rates of skin cancer (CMM, BCC, and SCC) in patients with short-term or long-term exposure to TZs as well as in patients with short-term or long-term exposure to a) CCBs and b) RAASi. We will then calculate incidence rate differences (RDs) and incidence rate ratios (IRRs) with 95% confidence intervals (CIs) adjusted for several confounders to quantify the risk of skin cancer associated with exposure to TZs, compared with exposure to a) CCBs and b) RAASi.
These data will provide clinicians additional data to weigh the benefits and harms of TZ use in their patients.
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National and local perspectives in venous leg ulceration: estimating prevalence and mapping referral pathways — Alun Davies ...
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National and local perspectives in venous leg ulceration: estimating prevalence and mapping referral pathways
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-06
Organisations:
Alun Davies - Chief Investigator - Imperial College London
Safa Salim - Corresponding Applicant - Imperial College London
Aoife Molloy - Collaborator - NHS England
Azeem Majeed - Collaborator - Imperial College London
Layla Bolton - Collaborator - Imperial College Healthcare NHS Trust
Sarah Onida - Collaborator - Imperial College London
Toqir Mukhtar - Collaborator - Imperial College LondonOutcomes:
Venous leg ulceration (VLU). This is defined by the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) stages of chronic venous disease as stages C5 and C6, corresponding to healed and active ulceration respectively. Read codes corresponding to these CEAP stages have been identified (see Appendix)
- VLU secondary care referralsDescription: Technical Summary
The aim is to investigate the burden of VLU in primary care across different regions in England. To do this we will use a retrospective population-based cohort study design to calculate the 12-month period prevalence, every year, over a 10-year period in CPRD. The study population will be all patients in the CPRD-HES linkage subset within each 12-month interval over the 10-year period. Prevalent cases will be all patients with a Read code corresponding to VLU (see Appendix). Prevalence will then be stratified to deprivation and the geographical region of the patient which will be determined through the Patient Level Index of Multiple Deprivation Domains in CPRD.
Through this retrospective cohort study design, we also aim to estimate the proportion of patients referred for their VLU from primary care to secondary care in each region. Patients who have been referred to secondary care will be defined as patients who either have referral codes in CPRD linked to a VLU encounter or who, through HES data linkage, are found to have been seen in hospital outpatients for their VLU. The number of patients who were referred to secondary care for their VLU will be expressed as a percentage of all VLU patients within that time frame. The proportion of referred patients will be stratified to geographical region.
A further aim is to assess how the referral patterns of VLU has changed since National Institute for Health and Care Excellence (NICE) published guidance on the management of varicose veins and VLU in 2013. The percentage of patients who have been referred to secondary care for their VLU will be calculated for each 12-month period over the 10-year interval of 2008-2018; this represents 5 years before and after publication of the NICE guidance.
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A study of life years lost and care pathways in people with learning disabilities: a real-world observational study — Freya Tyrer ...
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A study of life years lost and care pathways in people with learning disabilities: a real-world observational study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-18
Organisations:
Freya Tyrer - Chief Investigator - University of Leicester
Freya Tyrer - Corresponding Applicant - University of Leicester
Gyles Glover - Collaborator - Public Health England
Mark Rutherford - Collaborator - University of Leicester
Panos Vostanis - Collaborator - University of LeicesterOutcomes:
All-cause mortality (life expectancy)
Description: Technical Summary
Background: People with learning disabilities are known to die prematurely. However, the contribution of individual demographic, lifestyle and comorbid factors to premature mortality in this population remains unclear. Moreover, the role of service provision and healthcare received in the primary and secondary care sector has not been fully quantified.
Objectives: This study aims to: (i) explore differences in life expectancy between people with and without learning disabilities; (ii) quantify the impact and magnitude of demographic, lifestyle and comorbid factors on excess deaths in people with learning disabilities; and (iii) explore primary and secondary care pathways, and causes of death, to identify any gaps in care that might contribute to excess mortality in the learning disability population.
Design: A real-world observational study using linked primary care, hospital and mortality data of approximately 33,000 people with learning disabilities and a random comparison group (1 million) of the general population.
Methods: Flexible parametric methods will be used to calculate life expectancy in the study and comparison group. The contribution of demographic and comorbid conditions to life expectancy will be assessed using two methods: (i) multi-variable adjustment and (ii) propensity score matching. Primary and secondary care pathways and causes of death, including standardised mortality ratios, will be further examined to identify any gaps/differences in care that might contribute to excess mortality.
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Comparative effectiveness and safety of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers on the risk of major cardiovascular events, cancer and renal outcomes — Darren Ashcroft ...
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Comparative effectiveness and safety of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers on the risk of major cardiovascular events, cancer and renal outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-12-20
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Alison Wright - Corresponding Applicant - University of Manchester
Ireny Iskandar - Collaborator - University of Manchester
Martin Rutter - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Naveed Sattar - Collaborator - University of Glasgow
Salwa Zghebi - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Outcome1 - Cardiovascular
? 3-point major adverse cardiovascular events (MACE): myocardial infarction/acute coronary syndrome, stroke/transient ischaemic attack and cardiovascular death
? 4-point MACE: unstable angina, myocardial infarction/acute coronary syndrome, stroke/transient ischaemic attack, and cardiovascular death
? Myocardial infarction
? Stroke
? Heart failure and heart failure hospitalisation
Outcome 2 Â Cancer (site-specific)
? Cancer incidence
? Cancer mortalityOutcome 3 - Death
? Cause-specific mortalityOutcome 4 Â Renal
? Renal disease: chronic kidney disease stage 3 and above, nephritis, nephritic syndrome, nephropathy
? End stage renal disease: chronic kidney disease stage 5, renal failure, dialysis and/or renal transplantationOutcome 5 Â Negative control outcomes
? Fracture
? Serious/major gastrointestinal (GI) bleedsDescription: Technical Summary
Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) are widely used in the treatment of hypertension and heart failure, with the two medications deemed to be interchangeable when one class is not tolerated. However, debate has been raised regarding whether these drug classes are similarly effective, with indications of different adverse events associated with each class.
Following a clinical trial in 2004, controversy surrounded the use of ARBs as it appeared to increase the risk of myocardial infarction among people with hypertension. Since then, numerous studies have tried to assess the safety of ACEIs relative to ARBs and have produced inconsistent results for cardiovascular risk and mortality. Similarly, there are conflicting reports from recent studies and meta-analyses on cancer risk associated with both drugs. Both agents have demonstrated renoprotective effects; however it is unclear if these agents offer similar benefits or if one agent is superior.
As ARBs entered the market much later than ACEIs, patient profiles of those in ARB and ACEI trials were very different, with changes in primary and secondary prevention strategies occurring over that period. Therefore, it is of importance to establish and directly compare the safety of these drugs in contemporary, clinical practice with longer-term follow-up.
Data will be obtained from CPRD GOLD and Aurum, with a common protocol applied across the databases for cohort construction and analysis. The study populations will consist of any individual initiating an ACEI or ARB between 01/01/1998-31/05/2018, with follow-up until 30/11/2018. Hazard ratios for the outcomes of interest among patients receiving ACEIs, as compared with those receiving ARBs, will be estimated from Cox regression models and the data from the separate study cohorts will be meta-analysed with the use of random-effects models. All analyses will be replicated in a cohort of people with type 2 diabetes.
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Retrospective Study into the Journey of Patients with Fabry disease in the Integrated Health and Social Care System in North West London — Imperial College Healthcare NHS Trust...
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Retrospective Study into the Journey of Patients with Fabry disease in the Integrated Health and Social Care System in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Dec-19
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Fabry disease. Commercial
Source
2019 - 11
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Characteristics, treatment patterns and burden of illness in UK asthma patients prescribed ICS/LABA and LAMA — Wilhelmine Meeraus ...
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Characteristics, treatment patterns and burden of illness in UK asthma patients prescribed ICS/LABA and LAMA
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-15
Organisations:
Wilhelmine Meeraus - Chief Investigator - GlaxoSmithKline - UK
Wilhelmine Meeraus - Corresponding Applicant - GlaxoSmithKline - UK
George Mu - Collaborator - GSK
Leah Sansbury - Collaborator - GlaxoSmithKline - UK
Sandra Joksaite - Collaborator - GlaxoSmithKline - UK
Shiyuan Zhang - Collaborator - GSKOutcomes:
Primary care prescribing of multiple inhaled triple therapy (MITT) comprising a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid / long-acting ?2 agonist (ICS/LABA) in two inhalation devices; MITT treatment patterns and adherence; patient demographics; clinical characteristics (including comorbidities); primary care prescribing of asthma medications; asthma exacerbations (managed in primary and/or secondary care); healthcare resource utilisation (including primary care consultations, outpatient appointments, A&E attendance and hospitalisations)
Description: Technical Summary
This retrospective cohort study aims to describe individuals with asthma who initiate multiple inhaled triple therapy (MITT), comprising an ICS, a LABA and a LAMA in England between 2010 and 2017. Two cohorts of patients initiating MITT in primary care will be identified: (a) those who step-up to MITT by adding a LAMA therapy to ongoing treatment with an ICS/LABA fixed dose combination (FDC); and (b), those who step-up to MITT by adding ICS/LABA FDC therapy to ongoing treatment with a LAMA. Key outputs of this study are a description of MITT treatment patterns in the first year after initiation (including discontinuation, adherence and treatment with ICS/LABA or LAMA in the 60 days after discontinuation); and description of patient characteristics and burden of illness in the 12 months prior to the index date (MITT initiation) and the 12 months after the index date. Treatment patterns, patient characteristics and burden of illness will be reported for each cohort. A further four sub-groups will be defined (within each cohort) based on treatment patterns in the first year after initiation of MITT (continuous ÂuseÂ, step-down to LAMA, step-down to ICS/LABA and step-down to neither LAMA nor ICS/LABA). Patient characteristics and burden of illness will be additionally described by these four sub-groups. All patients in the study will be required to contribute 12 months of data prior to the index date (initiation of MITT) and 14 months after the index date. The requirement for 14 months post index date is to allow analysis of treatment patterns in the 60 days after discontinuation for those patients who discontinue close to the end of their first year following initiation. Only patients who are eligible for linkage with HES data will be included as HES-APC, HES-A&E, and HES-OP data will be used to classify exacerbations and describe healthcare resource utilisation.
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Retrospective study on Multi-vessel disease and prevalence of major adverse cardiovascular events: a CPRD-HES Study from 2008 to 2017 (The ReMoVe MACE Study) — Adrian Paul J. Rabe ...
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Retrospective study on Multi-vessel disease and prevalence of major adverse cardiovascular events: a CPRD-HES Study from 2008 to 2017 (The ReMoVe MACE Study)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
Prevalence of MVD; Demographics (Mean and median age on inclusion, age distribution by decade, sex distribution, deprivation, Charlson co-morbidity score distribution, mean and median follow-up, total and mean admitted time), prevalence of Myocardial infarction, non-fatal stroke, pulmonary embolism, cardiovascular death within the cohort; Healthcare resource outcomes (prescriptions issued in primary care, number of inpatient admissions, inpatient length of stay, inpatient HRG tariffs); Clinical outcomes (mortality, destination after discharge)
Description: Technical Summary
The presence of multi-vessel disease (MVD) is defined by the presence of ? 50 percent stenosis of two or more epicardial coronary arteries. With current advancements in drug research, there is hope that MVD can be managed by management of cholesterol, treating high-risk patients following an acute myocardial infarction (MI) which would in turn reduce the morbidity, mortality and health care costs associated with them. However, there is limited understanding of the most at-risk patients which would affect the impact of targeted treatments if they are to be made available on the NHS. There is also a limited availability of knowledge on the prevalence of MVD and the incidence of Major Adverse Cardiovascular Events (MACE) in this group.
This study aims to ascertain the prevalence of MACE in patients diagnosed with MVD. This will be done by creating a cohort of patients with MVD using an algorithm based on codes. Three sub cohorts will be created out of the main cohort based on co-morbidity with diabetes and availability of at least one risk factor or availability of two or more risk factors (prior MI, Peripheral Artery Disease (PAD) or aged 65 or over).
We shall describe demographic characteristics, prevalence of MACE, cardiovascular treatment prescribed and mortality. Health care resource usage will also be calculated and reported for inpatient admissions, cost, length of stay and destination on discharge. Outcomes will be described as total, means, medians, percentage or rates as appropriate.
Unadjusted odds ratios and mean incidence along with 95% confidence intervals will be calculated for all MACE, MI, non-fatal stroke and cardiovascular death at 90 days and 1,2,3 and 4 years on comparing each cohort matched controls. We shall adjust for age, sex and any other risk factors that we may identify as having an effect on the dependent variables.
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Patient and clinical characteristics of new users to single or multiple inhaled triple therapy in patients with COPD in the UK — Kieran Rothnie ...
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Patient and clinical characteristics of new users to single or multiple inhaled triple therapy in patients with COPD in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-01
Organisations:
Kieran Rothnie - Chief Investigator - GlaxoSmithKline - UK
Kieran Rothnie - Corresponding Applicant - GlaxoSmithKline - UK
Afisi Ismaila - Collaborator - GSK
Leah Sansbury - Collaborator - GlaxoSmithKline - UK
Sandra Joksaite - Collaborator - GlaxoSmithKline - UKOutcomes:
Patient demographics; Respiratory history and disease severity; Respiratory medications; Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations)
Description: Technical Summary
The objective of this study is to characterize a cohort of COPD patients who initiate an inhaled triple regimen for the first time between Nov 2017-Nov 2018, either as: 1) Single inhaled triple therapy (SITT) (LAMA+LABA+ICS delivered in a single inhaler) or; 2) Multiple inhaled triple therapy (MITT) (LAMA+LABA+ICS by either using three separate therapies or a monotherapy coupled with a fixed combination dual therapy). In a cohort of COPD patients who were actively registered in CPRD practices, we will describe patient characteristics in the prior to initiation of inhaled triple therapy for the first time. Patient characteristics will include sociodemographics, comorbidities, COPD burden (including recent COPD exacerbations, degree of airflow limitation, and MRC breathlessness score), prior medication use, and recent healthcare resource utilisation. We will use linked HES admitted patient care data to identify hospitalised exacerbations of COPD, and HES outpatient data to ascertain recent secondary care healthcare resource utilisation. This is a cross-sectional descriptive study, and we will not follow up patients for health outcomes following initiation of inhaled triple therapy.
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Retrospective Cohort Study of Medium-dose ICS/LABA patients who received add-on in comparison to patients who titrated to high-dose ICS/LABA in the United Kingdom — Raymond Przybysz ...
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Retrospective Cohort Study of Medium-dose ICS/LABA patients who received add-on in comparison to patients who titrated to high-dose ICS/LABA in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-04
Organisations:
Raymond Przybysz - Chief Investigator - NOVARTIS
Patrick Ward - Corresponding Applicant - Novartis Ireland Limited
Abhishek Srivistava - Collaborator - NOVARTIS
Anas Al Zabiby - Collaborator - NOVARTISOutcomes:
Treatment failure; Time to exacerbation; exacerbation rates; healthcare resource use
Description: Technical Summary
Uncontrolled patients with asthma typically have worse health outcomes and a lower quality of life. The aim of this study is to characterize the effect an additional controller being added to a patientÂs treatment has in relation to their time to treatment failure. The study will also report the frequency of exacerbation events, healthcare utilization, and investigate potential predicting factors in patients with additional controllers added. The Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) will be used to identify asthmatic patients. Patients on medium dose inhaled corticosteroids (ICS) in combination with long-acting Ã2 agonist (LABA) will be investigated to examine two cohorts of uncontrolled asthmatic patients; Patients who titrated up to a high dose ICS/LABA compared to patients who had a LAMA added to their medium ICS/LABA treatment. Both adult and adolescent patients will be included in this study and analysed in combination and separately. Cox regression models and Kaplan MeierÂs will be used for the primary endpoint of time to treatment failure for both cohorts. Index date will be set as the date additional controller is added, either high ICS or LAMA depending on cohort.
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Comparative effectiveness and safety of NOACs versus warfarin in UK patients with non-valvular atrial fibrillation and type 2 diabetes: a retrospective cohort study — Anthonius de Boer ...
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Comparative effectiveness and safety of NOACs versus warfarin in UK patients with non-valvular atrial fibrillation and type 2 diabetes: a retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-01
Organisations:
Anthonius de Boer - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Fatima Rüstem Güllüoglu - Collaborator - Utrecht Institute for Pharmaceutical Sciences
Hendrika van den Ham - Collaborator - Utrecht University
Joris Komen - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes:
HRs of stroke (ischaemic, non-specified and haemorrhagic stroke), myocardial infarction, major bleeding (gastrointestinal (GI), intracranial, and bleeding on other sites).
Description: Technical Summary
Atrial fibrillation (AF) is associated with a five-fold risk of stroke. Type 2 diabetes (T2DM) is one of the most common comorbidities in AF patients, and a well-known risk factor for stroke. Additionally, T2DM patients have high prevalence of comorbidities predisposing to bleeding.
Objective: With this study we aim to compare the risk of stroke and major bleeding associated with NOACs compared to warfarin in patients with NVAF and T2DM in the Clinical Practice Research Datalink (CPRD)
Methods: A retrospective cohort study using the UK CPRD. Participants are patients with a registered diagnosis of AF and T2DM, who are 1-year naïve users of NOACs or Warfarin, followed from the date of first prescription until the end of follow-up period, death, discontinuation of treatment for more than 180 days, switching or an
outcome of interest, whichever came first.Outcomes: HRs of stroke (ischaemic, non-specified and haemorrhagic stroke), myocardial
infarction, and major bleeding (gastrointestinal (GI), intracranial, and bleeding on other sites).Statistical analysis: The number and percentage of users with comorbidity or concomitant medication at baseline will be calculated, as well as the crude incidence rates of outcomes within 1 year per 100 person-years. Cox proportional hazard regression analysis will be performed to estimate the HR adjusted for a history of comorbidities and drug use. The effect of continuous treatment will be considered in the analysis by taking discontinuation and switching events into account.
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Safety of colchicine prophylaxis when initiating urate-lowering therapy for gout and prognostic factors for adverse events: an observational study in UK primary care using the Clinical Practice Research Datalink — Edward Roddy ...
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Safety of colchicine prophylaxis when initiating urate-lowering therapy for gout and prognostic factors for adverse events: an observational study in UK primary care using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-21
Organisations:
Edward Roddy - Chief Investigator - Not from an Organisation
Ram Bajpai - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Harry Forrester - Collaborator - Keele University
Lorna Clarson - Collaborator - Not from an Organisation
Rebecca Whittle - Collaborator - Keele University
Richard Partington - Collaborator - Keele University
Sara Muller - Collaborator - Keele UniversityOutcomes:
Work packages 1 and 3.
Adverse events associated with colchicine that are serious enough to warrant seeking healthcare: diarrhoea; nausea; vomiting; neuropathy; myalgia; myopathy; rhabdomyolysis; bone marrow suppression.Work package 2
Prescription of drugs that have the potential to interact with colchicine: statins; fibrates; verapamil; diltiazem; digoxin; amiodarone; oral ketoconazole; macrolide antibiotics.Description: Technical Summary
Gout affects 2.5% of adults in the UK and causes flares of severe joint pain and swelling. Long-term treatment for gout involves taking urate-lowering drugs (e.g. allopurinol) to prevent flares. However, allopurinol initiation commonly triggers a gout flare, hence co-prescription of prophylactic colchicine to prevent flares is recommended. There is little evidence concerning the safety of colchicine prophylaxis despite colchicine being known to interact with several commonly prescribed drugs.
We will describe the safety of colchicine prophylaxis when initiating allopurinol treatment for gout, and assess prognostic factors for colchicine side-effects.
Specific objectives are to determine, in patients with gout prescribed colchicine prophylaxis when initiating allopurinol:
1. Risk of colchicine-related adverse events severe enough to warrant seeking healthcare;
2. Incidence of co-prescribing of drugs with the potential to interact with colchicine;
3. Prognostic factors for adverse events.The study will be undertaken using linked primary care and Hospital Episode Statistics data.
Work-package 1
Matched, retrospective cohort study. The incidence of colchicine-related adverse events (diarrhoea, nausea, vomiting, neuropathy, myalgia, myopathy, rhabdomyolysis, and bone marrow suppression) will be compared using Cox proportional hazards regression between patients with gout initiating allopurinol with and without colchicine. Matching will be based on propensity scores.Work-package 2
Using the exposed group from the work-package 1, we will describe the proportion of people with gout initiating allopurinol with colchicine prophylaxis who have a current prescription for medications (statins, fibrates, verapamil, diltiazem, digoxin, amiodarone, oral ketoconazole, macrolide antibiotics) that could potentially interact with colchicine.Work-package 3
Type II prognosis study. In the same exposed group, we will assess potential prognostic factors (age, gender, body mass index, chronic kidney disease, multimorbidity and co-prescriptions) for adverse events. Absolute risk of adverse events by potential prognostic factors will be quantified and Cox regression used to examine potential risk factors for adverse events.
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Dementia in South Asians: tailoring risk prediction by ethnicity — Naaheed Mukadam ...
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Dementia in South Asians: tailoring risk prediction by ethnicity
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-20
Organisations:
Naaheed Mukadam - Chief Investigator - University College London ( UCL )
Naaheed Mukadam - Corresponding Applicant - University College London ( UCL )
David Osborn - Collaborator - University College London ( UCL )
Gill Livingston - Collaborator - University College London ( UCL )
Irene Petersen - Collaborator - University College London ( UCL )
Kenan Direk - Collaborator - University College London ( UCL )
Kingshuk Pal - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )Outcomes:
Incidence and prevalence of all-cause dementia, AlzheimerÂs dementia, vascular dementia and mixed dementia
Description: Technical Summary
It is important to understand what causes dementia so we can find ways to prevent and treat it. So far, most of our understanding of dementia and how we might prevent or delay it, comes from studies of European people.
Studying dementia risk in diverse rather than homogenous populations makes research more relevant and impactful and increases understanding more about how dementia develops. This approach has been successful in understanding more about cardiovascular disease and diabetes but has not yet been used in dementia. Previous studies have shown a higher prevalence of dementia in South Asia compared to Europe indicating greater susceptibility. We plan to use routinely collected data from primary care, linked to hospital episode statistics and mortality data to understand more about how dementia develops in order to improve risk prediction and therefore improve dementia prevention in the longer term.
We currently do not know: dementia prevalence in UK based South Asians; dementia environmental risk factor frequency in South Asians; and the impact of these risk factors in South Asians.
We will first establish prevalence of all-cause dementia in different ethnic groups by finding all patients with recorded diagnoses of dementia/prescriptions for anti-dementia medication prior to a pre-specified date and dividing this by the number of people contributing data for that period. We will then establish the frequency of cardiovascular and lifestyle factors and the impact of each of these on dementia risk, stratified by ethnic group. Finally we will use a random selection of patients to develop a risk prediction model and will test its ability to predict dementia in those who did not contribute data for model development.
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What is the risk of decompensation and mortality after non-hepatic gastrointestinal surgery in patients with alcoholic liver disease? — David Humes ...
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What is the risk of decompensation and mortality after non-hepatic gastrointestinal surgery in patients with alcoholic liver disease?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
David Humes - Chief Investigator - University of Nottingham
Alfred (Alfie) Adiamah - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Joe West - Collaborator - University of Nottingham
Lu Ban - Collaborator - University of NottinghamOutcomes:
 Post-operative hepatic decompensation
 Post-operative rates of venous thromboembolism
 Post-operative Mortality at 30-days and Mortality at 1-yearDescription: Technical Summary
Background: Alcohol is the commonest cause of chronic liver disease worldwide and is reported to increase the risk of some benign and malignant gastrointestinal diseases for which surgery may be indicated. Operative mortality for gastrointestinal conditions is reportedly low in the general population. However, surgery in patients with alcoholic liver disease can precipitate hepatic decompensation and may be associated with a higher risk of mortality.
The main objective of this study is to determine the postoperative risk of hepatic decompensation, venous thromboembolism and mortality after extrahepatic gastrointestinal surgery in patients with alcoholic liver disease when compared with patients with no liver disease undergoing the same surgical procedures.
Design: HES data will be used to form a study population of all patients undergoing gastrointestinal surgery and linked to their primary care data (CPRD). Patients will be grouped into those with liver disease as the study cohort by the presence of relevant codes for liver disease. Those without liver disease will form the control group. Of the liver disease patients, those with an alcohol aetiology will be identified by a separate algorithm that includes codes for harmful use of alcohol, or via codes that specifically mention an alcohol related cause. Those with liver disease will be subsequently classified based on severity as cirrhotic or not cirrhotic and compensated or decompensated cirrhosis.
For each included surgical procedure, we will report crude rates of decompensation, rates of postoperative venous thromboembolism and rates of mortality. A Cox proportional hazards model will be fitted to the alcoholic liver disease cohort predicting risk of decompensation, venous thromboembolism and mortality following operation. From this, we will derive cumulative incidence functions. In the case of decompensation and venous thromboembolism we will account for the competing risk of death. These absolute risks will be reported overall and stratified where there is adequate power by the strata liver disease severity.
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Incidence of adverse events among adult users of insulin and apomorphine pumps in the United Kingdom Clinical Practice Research Datalink GOLD: a descriptive study — Susan Jick ...
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Incidence of adverse events among adult users of insulin and apomorphine pumps in the United Kingdom Clinical Practice Research Datalink GOLD: a descriptive study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-11
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Treatment discontinuation; skin infections; skin nodules; skin allergic reaction; dyskinesia; motor fluctuations; hallucinations/psychoses; impulse control disorder; somnolence; peripheral neuropathy; weight loss; suicidal behaviors
Description: Technical Summary
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), and apomorphine pump therapy, also known as continuous subcutaneous apomorphine infusion (CSAI) are used to deliver treatment as a subcutaneous infusion to patients with type 1 diabetes and ParkinsonÂs disease, respectively. The rates of adverse events associated with these pump systems (particularly in real-world settings where user error may be higher than in clinical trials) are not clear. In addition, adverse events associated with these treatments may be caused by the pump system rather than the medication. Using data from CPRD GOLD, we will estimate the incidence rates and cumulative incidence of adverse events among new users of pump systems. Analyses will be stratified by age, sex, BMI, indication for use (diabetes vs. ParkinsonÂs) and comorbidities to identify subgroups that may be at increased risk. These estimates will provide valuable data for patients and clinicians weighing different treatment options as well as for clinicians monitoring the use of these systems in their patients. These data will also provide a baseline for the expected rates of adverse events among pump users to be used by regulators in the evaluation of new treatments using pump systems.
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DISCOVER CKD: An observational study incorporating UK CPRD data to evaluate and describe the journey and management of patients with chronic kidney disease (CKD). — Glen James ...
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DISCOVER CKD: An observational study incorporating UK CPRD data to evaluate and describe the journey and management of patients with chronic kidney disease (CKD).
Datasets:GP data, Â Clinical outcomes and hospitalisation (for example: incidence, prevalence, time to event and risk [hazard ratios] of clinical events).
 Death and cause of death (where available).
 Disease progression (for example: eGFR decline, time to ESRD, time to incident anaemia).
 Healthcare resource use and cost (using NHS reference cost tables) (for example describe number of hospital visits).
 Treatment practice, patterns, medications, and medication adherence (for example: number and percentage of patients on CKD related treatments).
 Biochemical (laboratory value) monitoring and trajectories
 Risk factors associated with CKD progression, dialysis initiation, comorbidities and clinical outcomes.Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-06
Organisations:
Glen James - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Glen James - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Anubhav Kumar - Collaborator - ZS Associates
Chirag Dhawan - Collaborator - ZS Associates
David Wheeler - Collaborator - University College London ( UCL )
Eleni Rapsomaniki - Collaborator - Astra Zeneca Ltd - UK Headquarters
Hungta Chen - Collaborator - Astra Zeneca Inc - USA
Jil Billy Mamza - Collaborator - Astra Zeneca Ltd - UK Headquarters
Katarina Hedman - Collaborator - Astra Zeneca Ltd - UK Headquarters
Matthew Arnold - Collaborator - Astra Zeneca Ltd - UK Headquarters
Mina Khezrian - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ping Sun - Collaborator - Astra Zeneca Ltd - UK Headquarters
Saanidhya Srivastava - Collaborator - ZS Associates
Saheba Kaur Vasdev - Collaborator - ZS Associates
Sanchita Porwal - Collaborator - ZS Associates
Saurabh Sohlot - Collaborator - ZS Associates
Supriya Kumar - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tanmoy Bose - Collaborator - ZS Associates
Zoe (Zhuoxin) Jiang - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
 Clinical outcomes and hospitalisation (for example: incidence, prevalence, time to event and risk [hazard ratios] of clinical events).
 Death and cause of death (where available).
 Disease progression (for example: eGFR decline, time to ESRD, time to incident anaemia).
 Healthcare resource use and cost (using NHS reference cost tables) (for example describe number of hospital visits).
 Treatment practice, patterns, medications, and medication adherence (for example: number and percentage of patients on CKD related treatments).
 Biochemical (laboratory value) monitoring and trajectories
 Risk factors associated with CKD progression, dialysis initiation, comorbidities and clinical outcomes.Description: Technical Summary
CKD constitutes a major cost burden to healthcare systems worldwide, in the UK costing approximately £1.45 billion annually for patients with CKD stages 3 to end stage renal disease (ESRD). The health burden caused by CKD is likely to grow sharply over the next several years due to an increasing elderly population and the escalating prevalence of comorbid conditions such as type 2 diabetes (T2D). The Global Burden of Disease 2015 study estimated that, in 2015, 1.2 million people died from kidney failure, an increase of 32% since 2005(1). Analysing patient data from several countries (including the UK using the CPRD) will provide regional insights into the real-world patient journey and clinical management of CKD patients. The ambition is that the DISCOVER CKD study will provide the foundation and infrastructure for a large multinational cohort of patients with CKD for pooled or country specific analysis. Additionally, subgroups including but not limited to CKD stage, dialysis status, comorbidity status (e.g. anaemia) and treatment status will be evaluated and described by pooled analysis or country specific analysis.
Methods and analysis plan
All individuals with CKD fulfilling the inclusion criteria and who have at least 1 year of medical history prior to baseline (index) date will be considered. The index date will be either the first documented code of CKD or renal replacement therapy (RRT) on or after 2008 or the 2nd eGFR measure from eligible patients. For analytical purposes, we will include patients in CPRD alone, those also linked to HES data and patients with linkages to other data sources described in section K. CPRD will be combined with retrospective data from other data sources for pooled analysis where time-period coverage and data linkages allow or analysed separately for UK specific analyses and combined with results from other countries.
Source - and 16 more projects — click to show
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The economic and clinical burden of hyperkalaemia in England: a retrospective cohort study using the Clinical Practice Research Datalink — Michele Intorcia ...
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The economic and clinical burden of hyperkalaemia in England: a retrospective cohort study using the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
Michele Intorcia - Chief Investigator - Vifor Pharma
Cormac Sammon - Corresponding Applicant - PHMR Associates
Megan Besford - Collaborator - PHMR Associates
Mihail Samnaliev - Collaborator - PHMR Associates
Nadav Zadok - Collaborator - Vifor Pharma
Sharada Weir - Collaborator - Maverex LtdOutcomes:
Health Care Resource Utilisation (HCRU) outcomes
GP visits
Outpatient visit
Hospitalisations
Prescriptions
Emergency admissionsClinical outcomes
Time to subsequent hyperkalaemia
Major adverse cardiac event (MACE)
Death
DialysisDescription: Technical Summary
Hyperkalaemia describes abnormally high blood potassium levels above 5.0mmol/L and without appropriate treatment can lead to adverse clinical outcomes and increased utilisation of health resources. Accurate information on the incremental risk to patients and cost to the healthcare system associated with the condition allows for the appropriate planning of healthcare resources and accurate assessment of the benefits of new technologies designed to treat the condition. This study will analyse hyperkalaemia and non-hyperkalaemia patients and compare healthcare resource utilisation and costs between the two patient groups.
Annual utilisation counts (such as GP visits, hospitalisations and outpatient visits) and costs in the year prior to the serum potassium test and in the subsequent 10 years will be captured and compared using generalised linear models and generalised estimating equations. Analyses will also be stratified by setting (i.e. primary care, outpatient visit). The hazard of clinical outcomes including time to subsequent hyperkaliaemic event, major adverse cardiac event, dialysis and death will be compared between the hyperkalaemia and non-hyperkalaemia patients groups using Cox proportional hazard regression. We will seek to account for differences in the demographic and clinical profile of patients in the two groups by including a number of key prognostic variables available in the databases in the analyses.
Subgroup analyses will repeat the above analyses in individuals with (a) a prior diagnosis of stage 3-5 non-dialysis chronic kidney disease (stage 3-5 ND-CKD) and no prior diagnosis of heart failure (HF), (b) a prior diagnosis of HF and no diagnosis of stage 3-5 ND-CKD and (c) a prior diagnosis of HF and stage 3-5 ND CKD.
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Incidence of adhesive capsulitis in primary care in the UK, and associated inflammatory conditions — Daniel Prieto...
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Incidence of adhesive capsulitis in primary care in the UK, and associated inflammatory conditions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Andrew Carr - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Danielle Robinson - Collaborator - University of Oxford
Navraj Nagra - Collaborator - University of Oxford
Simon Hoy - Collaborator - University of Oxford
Stephanie Dakin - Collaborator - University of OxfordOutcomes:
 Primary or secondary care diagnosis of adhesive capsulitis.
 Associated diseases or conditions as suggested by previous literature: diabetes, hypothyroidism, cancer, stroke, heart disease.
 Diseases associated with chronic inflammation: pulmonary fibrosis, liver cirrhosis, atherosclerosis, inflammatory tendon disorders, auto immune disease/s, inflammatory bowel disease, mental health diagnoses including dementia, and all-cause mortality.Description: Technical Summary
We will conduct a cohort study looking at adhesive capsulitis through the interrogation of the CPRD database of primary care centres in the UK.
Objectives: 1.To measure the incidence of adhesive capsulitis, and to describe secular trends over time, and variation by UK region and socio-economic status;
2.To look at the association between adhesive capsulitis and the development of inflammatory conditions including diabetes, hypothyroidism, DupuytrenÂs, cancer, stroke, heart disease, pulmonary fibrosis, liver cirrhosis, atherosclerosis, gout, inflammatory tendon disorders, auto immune disease/s, inflammatory bowel disease, mental health diagnoses including dementia, and all-cause mortalityPopulation: Patients >18yo registered in the CRPD database that have a diagnosis of adhesive capsulitis/Frozen shoulder on their medical history and 1+ years of CPRD data available before diagnosis. They will be compared with a 1:5 age, sex and practice matched control cohort for Objective 2.
Exposure: diagnosis of frozen shoulder
Outcomes: Adhesive capsulitis, diabetes, hypothyroidism, DupuytrenÂs, cancer, stroke, heart disease, pulmonary fibrosis, liver cirrhosis, atherosclerosis, gout, inflammatory tendon disorders, auto immune disease/s, inflammatory bowel disease, mental health diagnoses including dementia, and all-cause mortality
Analyses: Incidence and prevalence rates of adhesive capsulitis will be measured overall and stratified by time (calendar year), region, and Index of Multiple Deprivation (IMD) quintile.
Using CPRD and linked HES data we will investigate which of these patients remain with their primary care physician and who is referred on, as well as how this varies according to region as well.
Finally, multivariable Cox models stratified by matched sets will be used to calculate adjusted Hazards Ratios for each outcome according to the presence/absence of adhesive capsulitis.Through this analysis we can confirm or disprove previous associations the disease has been shown to have with other conditions and investigate novel relationships to other fibrotic and inflammatory conditions that have been theorized.
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Epilepsy prevalence and incidence in the UK — Markus Reuber ...
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Epilepsy prevalence and incidence in the UK
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-13
Organisations:
Markus Reuber - Chief Investigator - University of Sheffield
Thamina Anjuman - Corresponding Applicant - Not from an Organisation
Aidan Neligan - Collaborator - Homerton University Hospital NHS Foundation Trust
Eleanor Yelland - Collaborator - CPRD
Jon Dickson - Collaborator - University of Sheffield
Simon Wigglesworth - Collaborator - Epilepsy ActionOutcomes:
Annual incidence of epilepsy by year of age and gender in the United Kingdom, England, Scotland, Wales and Northern Ireland
Point prevalence of epilepsy by year of age and gender in the United Kingdom, England, Scotland, Wales and Northern Ireland
Prevalence of epilepsy by 0-18 years, 19 Â 65 years and 66 years and older and gender by practice-level Index of Multiple Deprivation (IMD) decile within England, Scotland, Wales and Northern Ireland
Annual incidence of epilepsy by 0-18 years, 19 Â 65 years and 66 years and older and gender by practice-level Index of Multiple Deprivation (IMD) decile within England, Scotland, Wales and Northern Ireland
Prevalence of epilepsy by 0-18 years, 19 Â 65 years and 66 years and older and gender by patient postcode level Index of Multiple Deprivation (IMD) decile within England
Incidence of epilepsy by 0-18 years, 19 Â 65 years and 66 years and older and gender by patient postcode level Index of Multiple Deprivation (IMD) decile within England
Description: Technical Summary
The overall objective is to update current estimates for UK incidence and prevalence of epilepsy using the most current available data in the CPRD. The updated estimates will include stratification into relevant administrative and health geographies as well as relevant age-sex distributions. The estimates will also be stratified by decile of social deprivation using Index of Multiple Deprivation (IMD) data.
This study will attempt to ascertain all available cases of epilepsy using a sample of patient information submitted to the CPRD from participating General Practice facilities throughout the UK. Cases will be determined using GP Read Codes queried from the medical record along with a current prescription for an anti-epileptic drug from the CPRD product codes. The overall annual number of patients registered in the CPRD will also be included and used as a denominator for incidence and prevalence calculations.
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Cancer risk in patients with cirrhosis — Joe West ...
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Cancer risk in patients with cirrhosis
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
Joe West - Chief Investigator - University of Nottingham
Peter Jepsen - Corresponding Applicant - Aarhus University Hospital
Colin Crooks - Collaborator - University of Nottingham
Gro Askgaard - Collaborator - Aarhus University Hospital
Joanne Morling - Collaborator - University of Nottingham
Kate Fleming - Collaborator - University of Liverpool
Timothy Card - Collaborator - University of Nottingham
Trevor Hill - Collaborator - University of NottinghamOutcomes:
 Incidence rate and cumulative risk of cancer: A) for patients with cirrhosis compared to a general population sample without cirrhosis, and B) among patients with cirrhosis of differing socioeconomic status.
 Survival time and cause-specific mortality after cancer diagnosis: A) for patients with cirrhosis compared to a general population sample without cirrhosis, and B) among patients with cirrhosis of differing socioeconomic status.Description: Technical Summary
CANCER RISK
Patients with cirrhosis have an increased risk of many cancers, and they have a high absolute risk of hepatocellular carcinoma and head and neck cancer. Due to the high risk they might benefit from screening examinations, but such decisions require more accurate information than what is currently available. We aim to provide that information using linked data from hospital episode statistics, diagnostic imaging data, cancer registry data, and individual socioeconomic status. We will contrast absolute risk between cirrhosis patients and matched controls from the general population.Among patients with cirrhosis, we will examine risk factors for developing cancer. Our primary interest is in the effect of socioeconomic status on cancer incidence and cancer stage at diagnosis. We will use regression modelling to compare cancer incidence/stage and diagnostic routes across categories of socioeconomic status.
CANCER SURVIVAL
We will compare all-cause and cancer-related mortality from cancer diagnosis between patients with cirrhosis and the population controls. Depending on the number of patients with a specific cancer type, we will conduct separate analyses for the most prevalent cancer types. We will use Cox regression to estimate the effect of cirrhosis on mortality following cancer diagnosis, controlling for confounding.Within the cohort of patients with cirrhosis we will focus on the effect of individual socioeconomic status, examining the hypothesis that deprived patients are disadvantaged. We will also examine whether any discrepancies in survival between deprived and affluent patients are increasing over calendar time.
Finally, we will examine the interaction between the effects of cirrhosis and low socioeconomic status on survival time among patients with colorectal cancer. This will be based on a Cox regression model including an interaction term between cirrhosis and socioeconomic status, and confounders.
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A cohort study examining the association between mirtazapine and mortality risk in adults with a diagnosis of depression — Carol Coupland ...
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A cohort study examining the association between mirtazapine and mortality risk in adults with a diagnosis of depression
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-26
Organisations:
Carol Coupland - Chief Investigator - University of Nottingham
Rebecca Joseph - Corresponding Applicant - University of Nottingham
Chris Hollis - Collaborator - University of Nottingham
Julia Hippisley-Cox - Collaborator - University of Oxford
Richard Morriss - Collaborator - University of Nottingham
Roger Knaggs - Collaborator - University of Nottingham
Ruth Jack - Collaborator - University of Nottingham
Outcomes: All-cause mortality; cause-specific mortality (including cardiovascular disease and cancer); suicide or near-fatal deliberate self-harm
Description: Lay Summary
Mirtazapine is a treatment for depression in adults. Some studies have found a link between mirtazapine and increased risk of death compared to other antidepressants. However, other factors may make this link seem stronger than it is. For example, doctors may prescribe mirtazapine to terminally ill patients as it can increase appetite and promote sleep.
Technical Summary
The aim of this study is to better understand the relationship between mirtazapine and risk of death. We will look at the risk of specific causes of death, including heart disease and cancer. We will also look at whether there is a link between mirtazapine and attempted suicide.
We will use data from the Clinical Practice Research Datalink (CPRD) for this study. The dataset will include anonymised electronic medical records from general practices and hospitals, as well as anonymised death records. We will compare a group of patients taking mirtazapine with groups of patients taking other antidepressants. The groups will be made up of adult patients with depression. We will compare the risk of death or attempted suicide between the groups. Risk factors such as age, sex, and other health conditions will be taken into account in the analyses.
The study will provide further information about whether there is a link between mirtazapine and risk of death or attempted suicide. This will include whether there is a link with particular causes of death. This will be important information for doctors and patients when considering suitable antidepressant treatment.Previous studies have found an association between the antidepressant mirtazapine and increased risk of mortality. Further research is needed to confirm this association and to examine specific causes of death. The proposed study will compare mirtazapine to other antidepressants and investigate cause-specific mortality, controlling for relevant confounding.
We will perform a cohort study using the active-comparator new user design, selecting patients prescribed antidepressants between 1st January 2005 and 30th November 2018. Linked CPRD primary care data, Office for National Statistics (ONS) mortality data, and Hospital Episode Statistics (HES) admitted patient care data will be used.
The study population will comprise adult patients diagnosed with depression whose first antidepressant was a selective serotonin reuptake inhibitor (SSRI) and who were subsequently prescribed mirtazapine, venlafaxine, amitriptyline, or a different SSRI. Follow-up will start from the date of starting the new antidepressant.
There will be five exposure groups: those who switched to mirtazapine, those who started mirtazapine while continuing the original SSRI, and those who switched to venlafaxine, amitriptyline, or a different SSRI.
The outcomes will be all-cause and cause-specific mortality, and suicide/near-fatal deliberate self-harm. Cause-specific mortality will include cardiovascular disease, cancer, and the most common causes of death found within the study population. Date and cause of death will be taken from the ONS mortality dataset while near-fatal deliberate self-harm will be defined using a combination of primary care and HES data.
We will account for confounding factors including demographic characteristics, lifestyle factors, drug exposures, and comorbidities. These will be used to estimate propensity scores for each of the comparator drugs compared with mirtazapine.
Baseline characteristics and the most frequent causes of death will be summarised. Survival analysis using Cox and Fine-Gray (competing risk) regression will be performed, accounting for propensity scores.
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Co-prescribing of aldosterone antagonist and renin-angiotensin system drugs for heart failure in the UK primary care: assessing the impact of regulatory action — Katherine Donegan ...
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Co-prescribing of aldosterone antagonist and renin-angiotensin system drugs for heart failure in the UK primary care: assessing the impact of regulatory action
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-20
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Preeti Datta-Nemdharry - Corresponding Applicant - MHRA
Dervla Quinn - Collaborator - MHRA
Stephanie Dellicour - Collaborator - MHRAOutcomes:
Primary outcomes:
Co-prescription of aldosterone antagonist and ACEI or ARB; Adherence to recommended blood monitoring guidelines for potassium and creatinine after co-prescriptionSecondary outcomes: Hyperkalaemia (potassium > 6 mmol/L); Adherence to discontinuation guidelines in case of hyperkalaemia
Description: Technical Summary
While trials have reported on the clinical benefit of co-prescribing aldosterone antagonist and renin-angiotensin system (RAS) drugs in heart failure patients, follow up studies found inappropriate monitoring and higher rates of complications, such as hyperkalaemia, in clinical practice compared to the trials. In 2016, following a coronerÂs report, the MHRA issued a reminder to healthcare providers in Drug Safety Update (DSU) of the risk of hyperkalaemia and the need for frequent monitoring. The overall aim of the study is to evaluate the impact of the regulatory advice communicated by the MHRA on the co-prescription of aldosterone antagonists (spironolactone or eplerenone) and ACEI or ARB drugs. Using CPRD data we will assess the pattern of such co-prescriptions as well as adherence to the recommended blood monitoring over time (2014-2018) in all patients, aged 18 years and over, co-prescribed these drugs, and also specifically patients with heart failure.
We will conduct the analysis in a phased approach in which firstly we will perform a descriptive analysis to evaluate any patterns of co-prescribing. If the descriptive analysis shows notable differing trends before and after the MHRA reminder, then an interrupted time series (ITS) analysis will be conducted to assess the trend and level change. This will be a quasi-experimental design to examine prescribing trends and also adherence to blood monitoring for patients being co-prescribed aldosterone antagonists and ACEI/ARB before and after the regulatory advice. In addition, CPRD data will be linked to HES, as a sensitivity analysis, to assess whether a more complete ascertainment of patients with heart failure and hyperkalaemia can be ascertained from hospital records.
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Which histological subtypes of lung cancer exhibit underlying pre-diagnostic thrombocytosis? — Sarah Bailey ...
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Which histological subtypes of lung cancer exhibit underlying pre-diagnostic thrombocytosis?
Datasets:GP data, NCRAS Cancer Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-01
Organisations:
Sarah Bailey - Chief Investigator - University of Exeter
Melissa Barlow - Corresponding Applicant - University of Exeter
Justin Matthews - Collaborator - University of Exeter
Luke Mounce - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
The primary outcome is platelet count before cancer diagnosis. Patients with primary lung cancer will be identified from CPRD records using a pre-defined list of medcodes that identify this cancer type. This will be their first cancer of any type; those with subsequent cancers diagnosed will be eligible for inclusion. Linked NCRAS data will be used to sub-categorise patients into four groups, based on the histological sub-type of their cancer: adenocarcinoma, squamous cell carcinoma, large cell carcinoma, small cell cancer.
Description: Technical Summary
Thrombocytosis is a newly discovered risk marker of cancer. Our recent CPRD study (winning paper of the year) found that the one-year cancer incidence was 11.6% (95% CI 11.0 Â 12.3) in males and 6.2% (95% CI 5.9 Â 6.5) in females with thrombocytosis (1); far beyond the 3% risk threshold set by the National Institute for Health and Care Excellence (NICE) for urgent investigation for suspected cancer (2). Notably, lung cancer was the most common diagnosis associated with thrombocytosis. In this study, we aim to understand which histological sub-type of lung cancer (i.e. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, small cell lung cancer) is more strongly associated with it, which remains currently unknown.
This study forms the basis of this ISAC application, and it will utilise CPRD records linked to National Cancer Registration and Analysis Service (NCRAS) data and a matched cohort design (matched for age, gender, and practice) to determine which histological sub-type of lung cancer is most strongly linked to platelet count. This will form the basis for a second study (not to be conducted in the CPRD, but briefly described here) which involves an in vitro investigation of the biochemical nature of the signal released by the lung cancer cell subtype(s) identified in phase one that affect megakaryocyte physiology. We will only perform this phase on the histological subtypes identified in the CPRD study. Cell lines will be tested in vitro for their ability to promote megakaryocyte proliferation, differentiation and platelet formation in a co-culture system, using chromatographic fractionation, proteomics and classical biochemistry techniques to explore the mechanism(s) underlying the cancer-platelet association.
Together, this programme of work will contribute to identifying new ways to achieve earlier lung cancer diagnosis in primary care, and ultimately improve patient survival outcomes. It may also identify novel targets for biomarker development.
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Utilization and comparative effectiveness and safety of long-acting insulins and Neutral Protamine Hagedorn (NPH) in patients with type 2 diabetes — Samy Suissa ...
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Utilization and comparative effectiveness and safety of long-acting insulins and Neutral Protamine Hagedorn (NPH) in patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Vanessa Brunetti - Collaborator - McGill UniversityOutcomes:
Our outcomes of interest include major cardiovascular events (MACE; composite endpoint of myocardial infarction, ischemic stroke, and cardiovascular death), the individual components of MACE, all-cause mortality, hospitalization for heart failure, and severe hypoglycaemia.
Description: Technical Summary
Type 2 diabetes mellitus is a disease characterized by increased levels of blood glucose, which may subsequently lead to macrovascular (myocardial infarction [MI], stroke) and microvascular (neuropathy, nephropathy, retinopathy) complications. Treatment for type 2 diabetes includes use of antidiabetic drugs and then insulin when other treatments fail to achieve glycemic control. Although effective in lowering glycaemia, insulin is associated with adverse effects in patients with type 2 diabetes, including severe hypoglycemia. Recently, new long-acting insulin analogs (glargine, detemir, degludec) have entered the market; these insulins are believed to have a lower risk of hypoglycemia and provide better weight control in comparison with human intermediate-acting insulin isophane (i.e., neutral protamine Hagedorn or NPH).
The reported benefits with long-acting insulin analogs were observed in clinical trials, but these were conducted in highly selected patient populations. Recent observational studies have provided conflicting results and many had important methodological flaws that may have introduced bias. Additional methodologically rigorous observational studies with longer follow-up are needed to evaluate the effectiveness and safety of newer insulin analogs compared to human NPH insulin. This study will aim to address the gaps in the knowledge of the utilization, effectiveness, and safety of long-acting insulin analogs vs intermediate-acting insulin. Using CPRD Aurum, Hospital Episode Statistics, and data from the Office for National Statistics, we will include all patients with a first-ever insulin prescription (either long-acting insulins or NPH) from September 1st 2002 to March 31st 2019. We will first describe the utilization of these insulins over time and patient characteristics. We will then investigate their comparative effectiveness at preventing major adverse cardiovascular events (MACE) and hospitalization for heart failure, and their safety with respect to hypoglycaemia.
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Examining variations in prescribing safety for patients with mental illness in UK primary care — Douglas Steinke ...
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Examining variations in prescribing safety for patients with mental illness in UK primary care
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-20
Organisations:
Douglas Steinke - Chief Investigator - University of Manchester
Wael Khawagi - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Richard Keers - Collaborator - University of Manchester
Tony Avery - Collaborator - University of NottinghamOutcomes:
Variations between practices in the prevalence of each prescribing safety indicator and composite indicator in 2018; reliability of each mental health related prescribing safety indicators and composite indicator at practice level; patient and practice level characteristics associated with the composite indicator; prevalence of each prescribing safety indicator and composite indicator from 2009-2019.
Description: Technical Summary
The safety of prescribing specifically for patients with mental disorders in primary care has not been investigated in a large sample of the UK population. Therefore, this study aims to assess the safety of prescribing for patients with mental disorders in primary care across the UK in order to find targets for improving prescribing safety and reducing medication-related harm. Mental health related prescribing safety indicators will be used to evaluate the safety of prescribing. These indicators were developed using the Delphi consensus method to detect potentially hazardous prescribing and drug monitoring practice that may place patients with mental illnesses at significant risk of harm.
This study will be longitudinal to examine the change in the prevalence of different types of mental health related potentially hazardous prescribing and inadequate monitoring indicators between 2009-2019. In addition, a cross-sectional analysis will be conducted for 2019 data to explore the variations between practices and the reliability of each indicator. This study will also examine patient and practice-level characteristics that are associated with potentially hazardous prescribing and inadequate drug monitoring.
Data will be extracted from the Clinical Practice Research Datalink (CPRD GOLD) for all patients with the potential to trigger an indicator because of age, disease, and/or prescription. The proportion of eligible patients receiving a potentially hazardous prescription will be calculated with 95% confidence intervals (CI). Variations between practices will be quantified for each indicator and a composite indicator using mixed effects two level logistic regression model and will be estimated using the intraclass correlation coefficient (ICC). The reliability of each indicator and the composite indicator will be estimated using the Spearman-Brown Prophecy Formula. The associations between the composite and patient or practice characteristics will also be examined using multivariable two-level logistic regression.
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Drug utilisation studies using CPRD mapped to the OMOP Common Data Model: a proof of concept study assessing respiratory drug use in patients with asthma or COPD — Daniel Prieto...
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Drug utilisation studies using CPRD mapped to the OMOP Common Data Model: a proof of concept study assessing respiratory drug use in patients with asthma or COPD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University Hospitals
Katia Verhamme - Collaborator - Erasmus University Medical Center ( EMC )
Sara Khalid - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
The following drug utilisation components will be investigated:
 Incidence and prevalence of drug use expressed as number of users, number of defined daily doses and number of prescriptions
 Patient characteristics of users with regard to demographics (age and gender), use of concomitant drugs and disease severity.
 Changes over time such as changes in prescribing patterns over calendar time, effect of guidelines or safety warnings (= time series analysis) but also changes over time with regard to disease severity (treatment step-up and treatment step-down)
 Patient adherence expressed as medication possession ratio, proportion of days covered, treatment persistenceDescription: Technical Summary
Background: The use of electronic healthcare data is increasingly being proposed as a source of evidence to support drug development and regulatory decision making but also to understand the pathogenesis of diseases.
The use of multiple electronic health care databases is recommended, not only to increase sample size but also to investigate country specific differences, differences by type of databases (e.g. primary vs. secondary care) and to replicate findings. One of the challenges is the heterogeneity between the databases with regard to the underlying structures and semantic mapping. The interoperability of the data can be strongly improved by standardising the data to the OMOP common data model (CDM) and Standardized Vocabularies. This enables the use of standardised analytical pipelines, e.g. for drug utilization studies across Europe.Aims: EHDEN (European Health Data and Evidence Network) a European network project supported by the Innovative Medicines Initiative (IMI) aims to standardize health care data to a CDM and to develop and implement tools to facilitate research using databases mapped to the CDM.
As proof-of-concept study, we want to investigate respiratory drug use in patients with asthma or COPD
The specific aims of this study are the following:Â To test existing drug utilisation techniques and methodologies.
 To identify gaps in current drug utilisation techniques/methodologies hampering the fast conduct of drug utilisation studies.
 To develop key graphical assets facilitating the interpretation of drug utilisation data.
 To compare drug utilisation data gathered from CPRD mapped to the CDM to non-mapped CPRD data.Methods
CPRD GOLD will be mapped to OMOP CDM using validated extraction-transformation-loading (ETL) codes. Study participants are patients diagnosed with asthma or COPD based on the presence of a READ code for asthma and/or COPD (see appendix). Gemscript codes for respiratory drugs are also provided in the appendix.
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Eosinophilic asthma phenotypes and associated clinical outcomes — David Price ...
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Eosinophilic asthma phenotypes and associated clinical outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-08
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Derek Skinner - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Trung Tran - Collaborator - Astra Zeneca Inc - USAOutcomes:
The following asthma outcomes will be studied over one full year of data: numbers of asthma exacerbations; acute respiratory events, presence/absence of asthma control and all-cause and asthma-specific events of: hospitalisations; admissions to Accident & Emergency; outpatient visits; physician office visits in primary care
Description: Technical Summary
Aim: This study aims to characterise the group of patients with an eosinophilic phenotype of asthma who do not achieve disease control under current guideline-based therapy.
Design: The study will include a broad population of patients, aged ?13 years, who had active asthma at last data extraction from general practice and ?1 blood eosinophil count recorded after first asthma diagnosis.
Active asthma will be defined as ?1 prescription for a controller or reliever inhaler in the last 12 months.
Patients will be classified into four different grades of likelihood of eosinophilic asthma, based on the highest blood eosinophil count recorded combined with information on clinical features previously reported to be associated with T2-high inflammation, such as age of onset and presence of nasal polyps.
In addition, unsupervised k-means clustering analyses will be performed to identify groups of patients with a similar asthma phenotype. Agreement between both classification methods will be assessed.
Demographics, diagnosed comorbidities, clinical characteristics, such as asthma severity and control and health care resource utilisation (HCRU) will be described for different phenotypes (both predefined and clusters) and for the total population over the last 12 months. Analyses will be repeated among patients who underwent a recent annual review within the quality and outcomes framework using additional information on asthma symptoms and in the subgroup of these patients with severe asthma.
Among patients who had ?3 blood eosinophil counts available, characteristics of those with persistently high blood eosinophil counts will be compared with those of patients with intermittently or never high counts using a separate design. These groups will be characterised and compared in a baseline period and clinical outcomes & HCRU will be compared in a follow-up year, using the most recent eosinophil count as the index date.
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Diabetes Mellitus and frozen shoulder: risk, diagnosis and prognosis — Danielle van der Windt ...
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Diabetes Mellitus and frozen shoulder: risk, diagnosis and prognosis
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-20
Organisations:
Danielle van der Windt - Chief Investigator - Keele University
Brett Dyer - Corresponding Applicant - Keele University
Claire Burton - Collaborator - Keele University
Milica Bucknall - Collaborator - Keele University
Trishna Rathod-Mistry - Collaborator - Keele UniversityOutcomes:
Incident frozen shoulder and time to incident frozen shoulder (objective 1); Incident Diabetes Mellitus and time to incident Diabetes Mellitus (objective 2); Frozen shoulder surgery and time to frozen shoulder surgery (objective 3).
Note: Objectives are listed below in section E.Description: Technical Summary
Despite the prevalence of frozen shoulder being around five times more in people with DM than people without DM (1), there is still a lack of high-quality studies investigating how DM and frozen shoulder are associated. My recent systematic review has highlighted that poor adjustment for confounding and insufficient follow-up length have compromised the quality of evidence for DM as a risk factor for frozen shoulder. We will use time-to-event models to investigate the association between DM and frozen shoulder, whilst ensuring suitable adjustment for confounding (see section P) and attempting to account for missing data (see section Q). Causal mediation analysis using weighted Cox regression will be used to investigate the extent to which the DM and frozen shoulder relationship is mediated through other variables (see section N for potential mediators).
A meta-analysis of five studies has shown that the prevalence of DM in the frozen shoulder population is around 30% (1). However, my recent systematic review found only two studies that have investigated whether the presence of frozen shoulder could be indicative of a subsequent diabetes diagnosis. We will estimate the incidence of DM after a diagnosis of frozen shoulder and compare this to a population without frozen shoulder.
We will also investigate whether people with DM have worse outcomes compared to those without DM. To do this, we will test whether frozen shoulder patients with DM are more likely to require/receive surgery than those without DM using Cox regression. Since initially frozen shoulder is treated using conservative methods, and surgery is reserved only for stubborn cases of frozen shoulder, this may help to indicate whether the outcomes of frozen shoulder are worse in those with DM.
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Spillover effects of removing indicators from the Quality and Outcomes Framework — Matt Sutton ...
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Spillover effects of removing indicators from the Quality and Outcomes Framework
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-27
Organisations:
Matt Sutton - Chief Investigator - University of Manchester
Shaolin Wang - Corresponding Applicant - University of Manchester
Rachel Meacock - Collaborator - University of Manchester
Soren Kristensen - Collaborator - Imperial College LondonOutcomes:
We will examine the achievement over time for the patient-task pairs denoted in Table 1 as direct effects (DE) of indicator removal, within-paitent spillovers (WPS) and between-patient spillovers (BPS).
We will examine three types of patient-task pairs: those that were incentivised before the 2014 revision of the QOF but from which incentives were subsequently removed, those that remained incentivised, and those which were never incentivised by the QOF but are clinically recommended based on the NICE guidelines.
A full list of QOF indicators that we will examine is provided in Appendix 1. More specifically, the seven conditions and associated QOF indicators are:
1. Chronic kidney disease (CKD) Â CKD002, CKD004, SMOK002
2. Coronary heart disease (CHD) Â CHD003, CHD007, SMOK002
3. Hypertension (HYP) Â SMOK002
4. Diabetes (DM) Â DM002, DM003, DM004, DM005, DM018, SMOK002
5. Stroke and transient ischaemic attack (STIA) Â STIA009, SMOK002
6. Chronic obstructive pulmonary disease (COPD) Â COPD007, SMOK002
7. Atrial fibrillation (AF) Â AF005
The seven tasks are:
1. Body Mass Index (BMI) recording (BMI) Â DM002
2. Albumin:creatinine ratio test recorded (UP/C) Â DM005, CKD004
3. Cholesterol management (CH) Â CHD003, STIA005, DM004
4. Blood pressure management (BP) Â CKD002, DM003
5. Smoking status recording (SMK) Â SMOK002
6. Influenza immunisation (IIV) Â DM018, CHD007, COPD007, STIA009
7. Alcohol consumption recording (AC) Â MH007Description: Technical Summary
The Quality and Outcomes Framework (QOF) links financial incentives to the quality of care provided by general practices. Practices are rewarded for their performance against a list of indicators. The QOF underwent a major revision in 2014, when 40 of the 121 indicators were removed. It is important to understand what happens to the quality of care provided to patients when general practices are no longer incentivised to deliver these activities.
Previous studies have examined the direct effect of removing these indicators on the patients or activities targeted. However, the wider consequences for other patient groups or activities have not been considered. For example, doctors may now divert their efforts away from patients or activities that no longer attract financial incentives towards patients and activities that are still linked to incentives. We will use CPRD to examine whether the removal of financial incentives from the QOF resulted in wider Âspillover effects beyond the patient groups and activities directly targeted by this removal. We will use programme evaluation techniques (including interrupted time series) to test for wider spillover effects onto a) patients not targeted by the incentive removal, and b) activities not targeted by the incentive removal.
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The Incidence and Associated Healthcare Resource Burden of Thrombotic Thrombocytopenic Purpura (TTP) in England based on Healthcare Datasets — Adrian Paul J. Rabe ...
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The Incidence and Associated Healthcare Resource Burden of Thrombotic Thrombocytopenic Purpura (TTP) in England based on Healthcare Datasets
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-13
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
Prevalence of TTP; Prevalence of recurrence annualized incidence; Prevalence of co-morbidities and risk factors in the cohort (pregnancy, Cancer, HIV, SLE/Lupus, Sepsis, previous chemotherapy, previous stem cell transplant and previous use of quinine); Demographics (Mean and median age on inclusion, age distribution by decade, percent males, deprivation, total, mean and median follow-up, Ethnicity, Deprivation (IMD), Mortality rate, age at Mortality, survival at 5 and years, prevalence of peripheral artery disease (PAD) within the cohort, prevalence of Myocardial Infarction (MI) within the cohort, prevalence of Arrhythmia within the cohort, pregnancy loss, New-onset of hypertension, Anxiety/depression, cognitive impairment); Healthcare resource outcomes (prescriptions issued in primary care, procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes (mortality)
Description: Technical Summary
The last 20 years have been marked by widening the knowledge base of the association between TTP and a disintegrin and metalloprotease with thrombospondin type 1 repeats, member 13 (ADAMTS13). Based on this better understanding of the pathophysiology of TTP combined with improved reporting of TTP in primary care, major advances in the comprehension of this historically fatal disease related to widespread microvascular platelet thrombi have been made. This has allowed a significant improvement in both diagnosis and therapeutic management of TTP. Although the pathogenesis, overall incidence, aetiology and presentation of TTP are now better understood, there is still limited knowledge on the associated mortality and survival rates, co-morbidities and healthcare resource use and, costs of TTP in England.
This will be a descriptive study which aims to determine which patients were diagnosed with TTP and determining the incidence and prevalence in different age groups, pre-diagnosis risk factors, co-morbidities, mortality, survival rates and health care resource use and costs. The study design has been chosen as this is appropriate for data extracted from healthcare datasets that already have data collected retrospectively. This will be done by creating a cohort of TTP patients using read codes reported in the primary care dataset. CPRD-HES linked dataset has been chosen due to the availability of good quality data for prescriptions, comorbidities, procedures, demographics, costs, complications, and resource use
We shall describe the cohort in terms of patient demographic characteristics, prevalence of comorbidities and selected risk factors. Health care resource usage for the cohort will be calculated and reported for inpatient admissions, outpatient appointments, A&E attendances, and primary care appointments, tests and prescriptions. Outcomes will be described as total, means, medians, percentage or rates as appropriate.
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Infectious burden and the risk of incident dementia: a nested case-control study — Samy Suissa ...
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Infectious burden and the risk of incident dementia: a nested case-control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-28
Organisations:
Samy Suissa - Chief Investigator - McGill University
Paul Brassard - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Carlo Fallone - Collaborator - McGill University
Christel Renoux - Collaborator - McGill University
Christina Santella - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill University
Zharmaine Ante - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
The primary outcome of interest is incident diagnosis of dementia, as identified by Read codes (listed in Appendix 1).
Description: Technical Summary
Given the ageing population, the prevalence of dementia is projected to triple in the upcoming years. Recently, mounting evidence has pointed towards the potential role of infectious burden in the pathophysiology of dementia. Currently, however, there remains a lack of high quality epidemiological evidence on the association between clinically apparent infections and the risk of dementia. Considering the rapidly growing number of individuals affected with dementia, future large-scale population-based studies are warranted on this potential association.
Our hypothesis is that clinically apparent diseases caused by H. pylori infection are associated with an increased risk of dementia. To investigate this potential association, we will conduct a cohort study with a nested case-control analysis using a cohort of all patients in the United Kingdom Clinical Practice Research Datalink at least 50 years of age between 1 January 1988 and 31 December 2019. Within this cohort, each dementia case will be matched with up to 40 dementia-free controls on sex, age (±1 year), cohort entry date (±90 days), and duration of follow-up. Conditional logistic regression will be used to compute odds ratios (ORs) with 95% confidence intervals (CIs) of incident dementia associated with H. pylori-related disease, compared with no exposure to H. pylori-related disease. In secondary analyses, we will assess the association by time since onset of H. pylori-related disease, sex and age (<65 and ?65). Finally, we will conduct several sensitivity analyses to assess the robustness of our results, including restricting the outcome definition to AlzheimerÂs disease (AD) and accounting for time-dependent confounding over the follow-up period. Ultimately, we hope the findings from this large population-based study can provide insight on the infectious burden of H. pylori and the risk of developing dementia in order to develop novel avenues for future preventive strategies.
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Comparative effectiveness of the cardiorenal disease outcomes between SGLT-2i and DPP-4i medication in population with type 2 diabetes  an observational study across England — Jil Billy Mamza ...
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Comparative effectiveness of the cardiorenal disease outcomes between SGLT-2i and DPP-4i medication in population with type 2 diabetes  an observational study across England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-11-20
Organisations:
Jil Billy Mamza - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Jil Billy Mamza - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Amitava Banerjee - Collaborator - University College London ( UCL )
Betina Blak - Collaborator - Astra Zeneca Ltd - UK Headquarters
George Godfrey - Collaborator - Astra Zeneca Ltd - UK Headquarters
Iskandar Idris - Collaborator - University of Nottingham
Kamlesh Khunti - Collaborator - University of Leicester
Mike Ford - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ruiqi Zhang - Collaborator - Astra Zeneca Ltd - UK Headquarters
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK Headquarters
Una Rigney - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
The study outcomes are aligned to the core objectives of this study and described below.
Primary objective: Cardiovascular and renal outcomes between new users of SGLT-2i and new users DPP-4i
Primary outcomes include specific hospitalisations for heart failure (HF), myocardial infarction (MI), stroke, peripheral artery disease (PAD), renal outcomes (including hospitalisation for kidney disease and end-stage renal disease [ESRD]), CV- and all-cause death, and their associated risk factors.
Secondary objective: Health care cost of CV and renal disease after initiation of SGLT-2i and DPP-4i
Secondary outcomes include monetised costs of health care resource use; resources include disease management services in the clinical guideline, e.g., GP consultations, laboratory tests, medications and hospitalisations.Description: Technical Summary
It is increasingly being recognised there are commonalities between cardiovascular, renal and metabolic (CaReMe) diseases with clinical overlap between these diseases and their associated complications. Although these relationships between disorders are increasingly being elucidated there is often under-recognition by health care professionals and patients and this contributes to patients being managed for conditions in isolation. These relationships are increasingly important as therapies develop that could address multiple aspects of disease outcomes and may be used across this spectrum of disorders. Using a cohort of prevalent type 2 diabetes (T2D) patients, we will compare the risk of cardiovascular and renal disease outcomes between new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and new users of dipeptidyl peptidase-4 inhibitors (DPP-4i) in Âcardiorenal disease-free patients. We compare the patterns of cardiorenal disease manifestation over time, and their subsequent association with adverse clinical outcomes such as cardiovascular (CV) and all-cause mortality where feasible. This study will utilise the CPRD Aurum database and the study period will begin on 1 January 2007 and will end on 30 September 2019. Each of the clinical outcomes of interest will be described separately. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Survival distributions utilising Kaplan-Meir method will describe time to cardiorenal disease progression, time to CV- and all-cause mortality. Relative risks and risk factors associated with outcomes will be estimated using Cox proportional hazard models. In addition, we aim to further evaluate and compare the healthcare cost benefit of the cardiovascular and renal outcomes between new users of SGLT-2i and new users of DPP-4i. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
Source
2019 - 10
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The Plan-it study: The acceptability and feasibility of a planned pre-pregnancy weight loss intervention — Sue Channon ...
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The Plan-it study: The acceptability and feasibility of a planned pre-pregnancy weight loss intervention
Datasets:GP data, HES Diagnostic Imaging Dataset; HES Outpatient; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-07
Organisations:
Sue Channon - Chief Investigator - Cardiff University
Fiona Lugg-Widger - Corresponding Applicant - Cardiff University
Elinor Coulman - Collaborator - Cardiff University
Freya Davies - Collaborator - Cardiff University
Hywel M. Jones - Collaborator - Cardiff University
Mandy Lau - Collaborator - Cardiff University
Rebecca Cannings-John - Collaborator - Cardiff University
Zoe Couzens - Collaborator - National Public Health Service for WalesOutcomes:
Specific to the CPRD workpackage:
 Rates of women in the UK who request LARC removal and subsequently have a pregnancy (using routine data).
 Identification of opportunities to intervene in preconception pathway (rates of LARC removal by month / year, overall numbers of women consulting for LARC removal).Description: Technical Summary
Work-package 1 will use routine data from CPRD relating to women attending for LARC removal.
The tasks are to set up access to anonymised data in order to:
- understand the pattern of LARC use to identify opportunities to intervene;
- report the annual number of women in the UK requesting removal of LARC without replacing it with an alternative prescribed contraception;
- determine the numbers of women requesting LARC removal who subsequently become pregnant who would be eligible to recruit to a weight loss intervention study
- determine the number of events in GP and hospital records to explore time from LARC removal to conception or appointments relating to difficulties conceiving (if possible).Inclusion Criteria:
Women of reproductive age (16-48 years old) who have a LARC use/removal Read Code during 01JAN2009-31DEC2018.Using CPRD data, it will be possible to map the time from LARC removal to conception (the estimated start date of pregnancy, attendance for a pregnancy scan and the first antenatal clinic visit), birth, then further contraception pattern. It will not be possible to definitively know from the routine data if a LARC was removed with the intention to start a family and therefore by following up patients, this will provide more insight with regards to their assumed motivation for LARC removal. We will examine the time between LARC removal and conception to see if a natural cut off exists. Using this cut off and in lieu of any events after LARC removal that would indicate that it was NOT for the purpose of planning a pregnancy (such as starting another form of contraception) it will be assumed that if a participant becomes pregnant in a certain period of follow-up allowed by the datasets, that LARC removal was for the purpose of planning a pregnancy. This will inform the numbers of potential participants available to take part in a future trial.
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Demographics, Treatment Pathways and Healthcare Resource Use among Patients with Secondary Progressive Multiple Sclerosis in England: The DEPTH Study — Adrian Paul J. Rabe ...
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Demographics, Treatment Pathways and Healthcare Resource Use among Patients with Secondary Progressive Multiple Sclerosis in England: The DEPTH Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-15
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
We shall measure the following: annual incidence and mean annual prevalence of SPMS, demographic and clinical profile (age, sex, follow-up, Charlson co-morbidity score, index of multiple deprivation), healthcare resource use and associated costs for inpatient care (admissions, length of stay, healthcare resource group [HRG] tariffs), outpatient care (appointments and HRG tariffs), A&E care (attendances and HRG tariffs), primary care (appointments, referrals, prescriptions), lines of therapy and medications in each line of therapy, morbidities following diagnosis, mortality rate.
Description: Technical Summary
SPMS is a debilitating autoimmune neurologic disease that results in paralysis and numbness of the body. Quantifying the healthcare resource and cost burden of SPMS on the NHS in England would be crucial for reviewing healthcare policies and treatment pathways for the disease.
We aim to determine the annual incidence and mean annual prevalence of SPMS using CPRD-HES linked data. For the SPMS cohort we have ascertained in the dataset, we will then determine their demographic and clinical profile, their healthcare resource use in primary and secondary care, the treatment pathway, and clinical outcomes.
CPRD-HES linked data is ideal for this study as we can track patients from primary care to secondary care, SPMS having significant healthcare journeys in both segments of the health system. Primary care data will provide us the diagnosis of patients, as well as appointments, referrals and prescriptions for the treatment pathway. Secondary care data will allow verification of the diagnosis of patients included, as well as healthcare resource use in the inpatient, outpatient and the A&E setting. Both datasets will be useful for determining patient outcomes. ONS data will provide reliable reference point for mortality to complete the treatment pathway of patients.
As this is mainly a descriptive study, no comparative testing shall be performed. Continuous outcomes will be reported as means with standard deviations, minima and maxima. Categorical outcomes will be reported as distributions of patients in terms of numbers and percentages of patients.
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Low-dose oral glucocorticoid therapy and risk of osteoporotic fractures in patients with rheumatoid arthritis: a cohort study using CPRD — Patrick Souverein ...
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Low-dose oral glucocorticoid therapy and risk of osteoporotic fractures in patients with rheumatoid arthritis: a cohort study using CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-10
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Anna Elise (Annelies) Boonen - Collaborator - Maastricht University Medical Centre
Frank de Vries - Collaborator - Utrecht University
Johanna Driessen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Shahab Abtahi - Collaborator - Utrecht University
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Occurrence of an osteoporotic fracture, including hip, clinically symptomatic vertebral, humerus, forearm, pelvic, and rib fractures.
Description: Technical Summary
Objectives: To investigate the effect of low-dose oral glucocorticoids (GC) on the osteoporotic fracture risk among patients with rheumatoid arthritis (RA).
Design: Retrospective cohort study using the Clinical Practice Research Datalink (CPRD) GOLD.
Participants: All adults aged 50 years and older diagnosed with RA in CPRD between 1997 and 2017. The Âindex date will be the RA diagnosis, recorded as the first read code for RA during valid data collection.
Primary exposure: The primary exposures of interest is the use of low-dose oral GC in RA patients, defined as an average daily dose ?7.5mg/d. Exposure to treatment will be assessed in a time-varying way and in 30-day follow-up periods.
Outcome: The outcome in our study is occurrence of the first incident osteoporotic (OP) fracture in RA patients after the index date, which include hip, clinically symptomatic vertebral, humerus, forearm, pelvic, and rib fractures.
Statistical analyses: Cox proportional-hazards models will be used to conduct the statistical analysis. The first and main analysis will compare the OP fracture risk between RA patients who are current users of low-dose GC, and RA patients who stopped taking GC for longer than 1 year (past users). Separate analyses will be conducted for various OP fracture sites. The secondary analysis will focus on a combination of average daily and cumulative dose of current GC use in RA patients and will be compared to past-use. All calculations will be adjusted for the potential confounders.
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Characterization of the deterioration of type 2 diabetes in patients with a subsequent diagnosis of pancreatic cancer  A descriptive study — Susan Jick ...
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Characterization of the deterioration of type 2 diabetes in patients with a subsequent diagnosis of pancreatic cancer  A descriptive study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-08
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Alexandra Mueller - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Cornelia Schneider - Collaborator - University of BaselOutcomes:
We will study type 2 diabetes patients with or without pancreatic cancer. In these patients, we will describe the following key variables before the cancer diagnosis (or the matched date): Number of antidiabetic treatment intensifications (defined as increase in the number of drug classes prescribed or start of insulin treatment); Timing of antidiabetic treatment intensification; Type of antidiabetic treatment intensification; Glycated haemoglobin levels; Changes in glycated haemoglobin levels; Body weight; Changes in body weight
Description: Technical Summary
In this descriptive study, we aim to identify characteristics of the deterioration of glycaemic control in the years preceding a pancreatic cancer diagnosis in patients with pre-existing type 2 diabetes. We will select patients aged >50 to 90 years with a first-time Read code for pancreatic cancer between 2004 and 2017 (index date) and a type 2 diabetes diagnosis > 3.5 years before the index date. Patients with type 2 diabetes, but without a pancreatic cancer diagnosis, will be used as comparison group.
We will assess intensification of antidiabetic treatment, changes in glycated haemoglobin levels, and changes in body weight before the index date in diabetic pancreatic cancer patients compared with diabetic non-cancer patients.
More specifically, we will evaluate the total number of antidiabetic treatment intensifications (defined as increase in the number of drug classes prescribed or start of insulin treatment) in the time period from 3 years until 6 months before the index date. We will determine time intervals between successive intensifications and types of intensification, and we will assess changes in glycated haemoglobin levels preceding treatment intensification. Other than treatment intensification, we will assess the temporal changes in glycated haemoglobin and body weight in the 3 years before the index date. Baseline will be the last glycated haemoglobin level or body weight recorded > 3 years before the index date but after onset of diabetes. We will stratify our analyses by diabetes duration, as well as by antidiabetic treatment intensification and body mass index, where applicable or appropriate.
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Trends in prescription of antidepressants and coprescription with other psychotropic medications in children and adolescents in UK primary care — Samy Suissa ...
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Trends in prescription of antidepressants and coprescription with other psychotropic medications in children and adolescents in UK primary care
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-20
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Dai Cao - Collaborator - McGill University
Emma Fergusson - Collaborator - Oxford University Hospitals
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jonathan Michaud - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Lara Fraga - Collaborator - Universidade Nove de Julho ( UNINOVE )
Laurent Azoulay - Collaborator - McGill University
Soham Rej - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
First prescription of antidepressants
Concomitant prescription of antidepressants with other psychotropic medications
Baseline characteristics of patients newly prescribed antidepressants : age, sex, body mass index, psychiatric diseases, other comorbidities and measures of health utilizationDescription: Technical Summary
In the UK, antidepressant prescriptions in children and adolescents increased in the early 2000s, followed by a brief decline from 2002 to 2005 as the Medicines and Healthcare Products Regulatory Agency issued warnings on the risk of suicide from these medications. In the following decade from 2005 to 2014, the rate of antidepressant prescriptions steadily rose again, approaching the prescriptions rates observed in 2002. The trends in prescriptions since 2015, however, are unknown. Another evolving pattern is the co-prescription of antidepressants with other psychotropic medications in this population. Several studies have shown that paediatric coprescription of antidepressants with other psychotropic medications has increased in Western countries but no recent study has been done in the UK. This trend carries important clinical and policy implications, as nascent evidence suggests that selective serotonin reuptake inhibitors (SSRIs), the most frequently prescribed antidepressant class in children and adolescents, independently raises the risk of incident type 2 diabetes and that concomitant use of atypical antipsychotics carry an additive risk of incident type 2 diabetes in this population. Thus, we will conduct a retrospective cohort to describe trends in prescriptions of antidepressants over time and coprescription with other psychotropic medications in children and adolescents in UK primary care between 2000 and 2018. The cohort will involve all patients between the age of 5 and 17 who are registered in CPRD during the study period. Analysis will include incident and prevalent rates for both antidepressant prescriptions alone and coprescription with other psychotropic medications. Rates will be stratified by age, sex, medication class, socioeconomic status and geographic region. We will also describe the most frequent coprescription combinations each year. Finally, we will compare patient characteristics in 2008 and 2018 to investigate changes in patient profile in the last decade.
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Association of chronic kidney disease with frailty and mortality in the multi-ethnic UK population: a CPRD study — Alice Smith ...
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Association of chronic kidney disease with frailty and mortality in the multi-ethnic UK population: a CPRD study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-30
Organisations:
Alice Smith - Chief Investigator - University of Leicester
Joanne Miksza - Corresponding Applicant - University of Leicester
Andrew Nixon - Collaborator - Lancashire Teaching Hospitals
Claire Lawson - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Hannah Young - Collaborator - University Hospitals Of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Thomas Wilkinson - Collaborator - University of LeicesterOutcomes:
 Our main outcome is development of frailty in CKD and non-CKD cohorts, stratified by CKD stage With frailty defined as eFI ? 0.13 and CKD as eGFR < 60, with no Read/ ICD 10 codes indicating dialysis or kidney transplant.
 Our secondary outcomes are all-cause and cardiovascular mortality in a CKD an non-CKD population by frailty level, and rates of dialysis and kidney transplant, in a cohort with CKD, by frailty level.
 Prevalence of frailty in the CKD and non-CKD cohortsDescription: Technical Summary
The purpose of this study is to explore associations between reduced renal function (i.e. chronic kidney disease (CKD), frailty and mortality in a UK population. A random selection of patients will be taken who were present in CPRD between January 2006 and December 2015 who had a least two serum creatinine levels recorded and were ?40 years old. The main objective is to investigate the association between stages of CKD and the development of frailty using the electronic Frailty Index (eFI). Renal status will be modelled as a time varying covariate in a cause specific competing risk survival analysis, using flexible parametric models to estimate time to occurrence of frailty and separately, death. Participants with frailty at baseline will be excluded.
For our secondary analyses, in people with CKD and non-CKD (stages 3a to 5) we will also use frailty category as a time varying covariate to investigate all-cause and cardiovascular mortality, as well as time to transplant or dialysis in participants with and without CKD by frailty category
Additionally we will calculate the prevalence of frailty in CKD and non-CKD groups at baseline. We will also identify which of the 35 remaining frailty deficits are most prevalent in frail CKD patients.
For this analysis Hospital Episode Statistics (HES) data will be used to provide more complete information on patient ethnicity and CKD related outcomes, and Office of National Statistics (ONS) death registration data will be used to identify the outcomes of all-cause and cardiovascular mortality.
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Effect of raised cardiovascular risk on the rates of acute respiratory infections and subsequent cardiovascular complications: a cohort study using electronic health records — Charlotte Warren...
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Effect of raised cardiovascular risk on the rates of acute respiratory infections and subsequent cardiovascular complications: a cohort study using electronic health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-10
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jennifer Davidson - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amitava Banerjee - Collaborator - University College London ( UCL )
Daniel Grint - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Richard Pebody - Collaborator - Public Health England
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Vanessa Saliba - Collaborator - Public Health EnglandOutcomes:
Primary
Aim 1 & 2: all-cause acute systemic respiratory tract infections. This includes clinical or confirmed diagnoses such as pneumonia, acute bronchitis, influenza / influenza-like illness (ILI), and other acute infections suggestive of lower respiratory tract improvement.
Aim 3 & 4: all-cause major adverse cardiovascular events (MACE). This includes; cardiovascular death, acute coronary syndrome (ACS) which captures both myocardial infarction (MI) and unstable angina, stroke, transient ischaemic attack (TIA), left ventricular heart failure and acute ischaemic limb.Secondary
Aim 1 & 2:
 Influenza / ILI
 pneumonia
Aim 3 & 4 cause-specific acute cardiovascular events:
 ACS,
 stroke / TIA,
 left ventricular heart failure,
 acute ischaemic limb, and
 cardiovascular death.Description: Technical Summary
In the UK there are an estimated 7 million people living with CVD, for which the annual costs are estimated to be £19 billion. As the population ages and multimorbidity prevalence increases, stratified interventions are ever more important. The risk of cardiovascular complications after an acute systemic respiratory infection in people with raised cardiovascular risk but without established CVD is unknown. Quantifying any such increased risk will inform whether these groups should be considered for influenza and pneumococcal vaccination.
Our cohort study will use CPRD data linked to HES and ONS mortality data to increase ascertainment of respiratory and cardiovascular events. We will define cardiovascular risk by hypertension diagnosis and QRISK2 score. QRISK2 is a prediction algorithm for future CVD which utilises a range of risk factors, beyond hypertension, to determine risk. We will first calculate age-specific incidence rates for diagnosis of acute systemic respiratory infections by cardiovascular risk among adults aged 40 to 64 years. We will compare 1) people with hypertension to those without hypertension and 2) people with a QRISK2 score ?10% in ten years compared to those with a QRISK2 score <10%. We will then use Poisson regression models with Lexis expansion by age group and cardiovascular risk level to estimate incidence rates and rate ratios for 1) acute systemic respiratory infections including influenza-like illness and pneumonia, and 2) major acute cardiovascular events (MACE). Using Cox proportional hazards regression multivariable models, which adjust for potential confounders, we will then estimate the effect of cardiovascular risk on MACE after an acute systemic respiratory infection. In our definition of MACE we will include; myocardial infarction, unstable angina, left ventricular heart failure, stroke, transient ischaemic attack, acute limb ischaemia and cardiovascular death.
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Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom — Michelle Bradney ...
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Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-07
Organisations:
Michelle Bradney - Chief Investigator - Medical Developments International
Nawab Qizilbash - Corresponding Applicant - OXON Epidemiology - Spain
Andrea Falco - Collaborator - OXON Epidemiology - Spain
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Kirsty Andresen - Collaborator - OXON Epidemiology - Spain
Lorena Baquero - Collaborator - OXON Epidemiology - Spain
Lucy Tran - Collaborator - OXON Epidemiology - UK
Mai Duong - Collaborator - Evidera, Inc
Olga de Agustin Bua - Collaborator - OXON Epidemiology - Spain
Raúl Sánchez - Collaborator - OXON Epidemiology - SpainOutcomes:
Hepatic and renal events in primary or secondary care.
Description: Technical Summary
Background: Methoxyflurane is an oral inhalation analgesic for emergency relief of moderate-severe pain in conscious adult patients with trauma and associated pain in pre-hospital and A&E departments. Launched in the UK in 25 January 2016, a PASS was imposed to confirm the absence of significant risks of hepatotoxicity and nephrotoxicity.
Objectives: The objective of the study is to assess whether there is an increased risk of hepatic or renal events due to methoxyflurane during routine clinical practice pre-hospital and in A&E departments in the UK.
Methods: This study is part of a hybrid study design that combines a primary data collection prospective comparative cohort study with methoxyflurane and a concurrent control group, with a retrospective non-concurrent cohort from routinely collected data. Data on exposure to methoxyflurane in patients aged >18 years and 12-week follow-up have been collected from 12 A&E departments. Data on exposure to other analgesics have been collected in the same way for the concurrent control arm. For the non-concurrent control cohort, patients aged >18 admitted with a fracture to A&E (index date) in the 24-month period from 2 November 2013 to 1 November 2015 (prior to the launch of methoxyflurane) will be obtained from the CPRD Gold-HES A&E linkage dataset. Hepatic and renal outcomes in the 12 weeks following index date will be identified in the CPRD Gold and Hospital Episode Statistics (HES) inpatient data. This study will describe each cohort and estimate the incidence rates of hepatic/renal events (cases/patient-month). Comparisons between rates in the prospective-exposure and the historical cohorts will use Poisson regression. Multivariable logistic regression will study factors associated with hepatic/renal events. Event free survival will use Kaplan-Meier analysis.
Importance: This study will provide information on the safety of the use of methoxyflurane for emergency pain relief in routine clinical care in A&E.
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Impact of variability in patient characteristics on effect estimates in observational studies: a retrospective multi-cohort study of rivaroxaban versus warfarin — Olaf Klungel ...
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Impact of variability in patient characteristics on effect estimates in observational studies: a retrospective multi-cohort study of rivaroxaban versus warfarin
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-06
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Lourens Bloem - Corresponding Applicant - Utrecht University
Arno W Hoes - Collaborator - Maastricht University
Aukje Mantel-Teeuwisse - Collaborator - Utrecht Institute for Pharmaceutical Sciences
Helga Gardarsdottir - Collaborator - Utrecht University
Hubert Leufkens - Collaborator - Utrecht University
Menno E. van der Elst - Collaborator - Medicines Evaluation BoardOutcomes:
Composite endpoint of stroke (ischaemic or haemorrhagic) and systemic embolism, major bleeding, angioedema
Description: Technical Summary
Background
For most medicines, post-approval data generation is important to further characterise or confirm their benefit-risk profile. Observational studies are especially suited to study e.g. effectiveness and safety outcomes but are also prone to various biases that may arise from variability in patient characteristics that may change over time due to deliberate decision-making during the drug life-cycle. Furthermore, increased sample size due to progress of the drug life-cycle will impact power to detect beneficial and adverse effects.Objectives
This study aims to quantify the impact of variability in patient characteristics and increasing sample size during a drug life-cycle on relative effectiveness and safety estimates and precision for a case-study of rivaroxaban versus warfarin indicated for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation. Furthermore, it aims to quantify the impact of significant regulatory, reimbursement and clinical decision-making on these estimates.Study design
This is a retrospective study of rivaroxaban versus warfarin, studying multiple cohorts of patients at different points in time during the life-cycle within the UK Clinical Practice Research Datalink between 2011 and 2019. Cohorts will vary in sample size and duration of follow-up and may vary in terms of patient characteristics. Patients with an incident diagnosis of non-valvular atrial fibrillation will be followed until the occurrence of stroke or systemic embolism, major bleeding or angioedema, or until a censoring event.Data analysis
Propensity scores will be used to identify patient variability between cohorts. To assess relative effectiveness and safety estimates for each cohort, we will model the data using Cox proportional hazards regression analyses and calculate hazard ratios and 95% confidence intervals, both unadjusted and adjusted for possible confounders. Individual estimates for each cohort and their evolvement over time will be described and visualised. The impact of decision-making will be assessed by adding interaction terms with these time points.
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Cardiovascular prognosis in patients with undiagnosed chest pain: an electronic health record cohort study — Kelvin Jordan ...
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Cardiovascular prognosis in patients with undiagnosed chest pain: an electronic health record cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-08
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Adam Timmis - Collaborator - Queen Mary University of London
Danielle van der Windt - Collaborator - Keele University
Harry Hemingway - Collaborator - University College London ( UCL )
James Bailey - Collaborator - Keele University
Lorna Clarson - Collaborator - Not from an Organisation
Mamas Mamas - Collaborator - Keele University
Milica Bucknall - Collaborator - Keele University
Richard Hayward - Collaborator - Keele University
Spiros Denaxas - Collaborator - University College London ( UCL )
Theocharis Kyriacou - Collaborator - Keele University
Trishna Rathod-Mistry - Collaborator - Keele University
Ying Chen - Collaborator - Keele UniversityOutcomes:
Primary: Any cardiovascular
event;
Secondary: i) coronary event; ii) cerebrovascular eventDescription: Technical Summary
Chest pain is a common symptom presented to general practice and may be caused by coronary heart disease or a non-coronary condition such as musculoskeletal disease or anxiety. Our previous study showed that many patients presenting to primary care with new chest pain will not receive a diagnosis and will not be investigated for coronary heart disease. However, studies including our own have also shown that patients with chest pain not attributed to a cause by the GP have an increased risk of future cardiovascular disease compared to those without chest pain and to those diagnosed with non-coronary chest pain. Investigation and instituting preventative measures in all undiagnosed patients with chest pain is not, however, practical. The aim of this study is to assess if it is possible to identify at time of presentation to primary care which patients with undiagnosed chest pain are at greatest risk of cardiovascular disease, and to model the effect of targeting key prognostic factors and preventative medication on incidence of cardiovascular disease in those at greatest risk. Patients presenting to primary care with new onset chest pain unattributed to a cause will be followed using their medical records for up to 10 years for incidence of cardiovascular disease, with a comparator group diagnosed with non-coronary chest pain. We will assess the performance of established cardiovascular risk algorithms in these groups, and use survival analysis to determine baseline factors most associated with onset of cardiovascular disease and to estimate the impact of reduction in levels of modifiable prognostic factors on incidence of cardiovascular disease. Routine assessment of these patients to identify those most at risk in order to offer preventative measures would be implementable in primary care and could contribute greatly to prevention of cardiovascular events.
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Burden of hip dislocation following total hip arthroplasty in England. — Thibaut Galvain ...
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Burden of hip dislocation following total hip arthroplasty in England.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-23
Organisations:
Thibaut Galvain - Chief Investigator - Johnson & Johnson Medical SAS
Thibaut Galvain - Corresponding Applicant - Johnson & Johnson Medical SAS
Abhishek Chitnis - Collaborator - Johnson & Johnson ( JnJ - USA )
Alexander Mensch - Collaborator - Johnson & Johnson ( JnJ - USA )
Cindy Tong - Collaborator - Johnson & Johnson ( JnJ - USA )
David Fawley - Collaborator - Johnson & Johnson ( JnJ - USA )
Jack Mantel - Collaborator - Johnson & Johnson ( JnJ - USA )
Jessica Behrle - Collaborator - Johnson & Johnson ( JnJ - USA )
Joshua Bridgens - Collaborator - Johnson & Johnson ( JnJ - USA )
Tim Board - Collaborator - University of ManchesterOutcomes:
Total cost at 2 years post-primary; Healthcare resource utilisation at 2 years post-primary; Mortality at 2 years post-primary; quality of life change due to dislocation (+/- revision).
Description: Technical Summary
The objective of this retrospective longitudinal cohort study is primarily designed to determine mid-term (two-year) costs, healthcare resource utilization (HRU, including hospital length of stay, length of ICU stay and costs, number of outpatient hospital visits and costs, number of community care resources utilization and costs), dislocation data (including number of dislocation and number of reduction procedures or revision surgeries for dislocation), and quality of life (QoL) among patients with dislocation versus those without following primary total hip arthroplasty. Patients with a primary total hip arthroplasty between 2010 and 2015 will be selected. The main exposure variable will be presence of dislocation within one year following the primary total hip arthroplasty. Patients with dislocation will be matched to patients without dislocation according to their propensity scores. Analyses will be both descriptive and comparative. Multivariable models will be used to adjust for residual confounding and appropriate generalized linear models (GLMs) will be chosen based on the outcome variable of interest for HRU, costs and QoL.
Secondarily as an exploratory analysis, the impact of lumbar spine surgery (12 months before PTHA or 12 months after PTHA) on the incidence of dislocation following PTHA will be evaluated. First, incidences of dislocation after PTHA will be calculated comparing patients with spinal surgery pre-PTHA to patient without spinal surgery pre-PTHA. Additionally, incidences of dislocation post-PTHA and post spinal surgery will be evaluated for patient with spinal surgery post-PTHA compared to patient without spinal surgery post-PTHA. Patients with spinal surgery will be matched to patients without spinal surgery according to their propensity scores. Analyses will be both descriptive and comparative. Multivariable logistic regression models will be used to adjust for residual confounding on the outcome variable of interest.
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Use of sodium-glucose co-transporter-2 inhibitors (SGLT-2-Is) and risk of lower limb amputation. — Frank de Vries ...
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Use of sodium-glucose co-transporter-2 inhibitors (SGLT-2-Is) and risk of lower limb amputation.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-15
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Johanna Driessen - Corresponding Applicant - Utrecht University
Bernardette Rossi - Collaborator - Maastricht University Medical Centre
Johan Roikjer - Collaborator - Aalborg University Hospital
Johannes T.H. Nielen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Nicolaas Schaper - Collaborator - Maastricht University
Niels Ejskjaer - Collaborator - Aalborg University Hospital
Nikki Werkman - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Peter Vestergaard - Collaborator - Aalborg University HospitalOutcomes:
Primary:
- Lower limb amputations (read codes are listed in appendix 6)Secondary:
- amputation of the foot (including ankle) (read codes are listed in appendix 4)
- amputation of the metatarsal bones and one or more toes (read codes are listed in appendix 3)
- amputation of the one or more toes (read codes are listed in appendix 5)
- diabetic foot ulcer (read codes are listed in appendix 1)
- ischaemic diabetic foot ulcer (read codes are listed in appendix 2)Description: Technical Summary
The objective of this study is to investigate the association between the use of sodium-glucose co-transporter-2 inhibitors (SGLT-2-Is) in comparison to other antidiabetic drugs and the risk of amputation of the lower limb by different sites. A possible mechanism for lower limb amputations is that SGLT-2-I use increases osmotic diuresis together with a reduction in extravascular volume which may lead to reduced tissue perfusion. We aim to investigate hypovolemia as a possible mechanism in this study.
We will first create a base cohort including all patients aged >18 starting with metformin only between 1998 and 2019. From this base cohort we will select all patients with a first ever prescription for a SU, DPP4-I or SGLT-2-I between 1-1-2013 and 30-6-2018. This study period is chosen as SGLT-2-Is have been available from 1-1-2013 in the UK. The date of the first prescription for a SU, SGLT-2-I, or DPP4-I will determine the indexdate. Every patient will be followed from his/her indexdate collection, death, or the outcome of interest, whichever comes first. The total follow-up will be divided into intervals of 30 days. At the start of each interval we will determine exposure to non-insulin anti-diabetic drugs (NIADs). Based on the time since the most recent prescription an interval will be classified as current (1-90 days) or past (> 90 days) NIAD use. Current use will be further stratified into current use of SUs (reference group), DPP4-Is, SGLT-2Is and other NIADs.
The primary outcome will be the risk of lower limb amputation. When volume restriction is the mechanism by which SGLT-2-Is increase the risk of amputation, we expect that patients using SGLT-2-Is will also have a higher risk of other foot problems, including an elevated risk of amputations of the lower limb, foot (toes) and a high risk of DFU.
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Temporal and regional trends in neuromuscular disease prevalence and incidence, and the health and healthcare of people with neuromuscular conditions in the UK between 2000-2018 — Iain Carey ...
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Temporal and regional trends in neuromuscular disease prevalence and incidence, and the health and healthcare of people with neuromuscular conditions in the UK between 2000-2018
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Carstairs Index for 2011 Census (Excluding Northern Ireland)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-29
Organisations:
Iain Carey - Chief Investigator - St George's, University of London
Iain Carey - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Niranjanan Nirmalananthan - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
Measures of healthcare utilisation (Primary care consultations, emergency admissions for ambulatory care sensitive conditions) and All-Cause Mortality
Description: Technical Summary
The project will utilise large routine national datasets to address the scarcity of up-to-date and accurate information on the epidemiology of neuromuscular disease (NMD) in the UK. It will use both the GOLD and Aurum primary care datasets, to classify patients with these rare conditions using Read codes and provide updated and detailed information on how many people in the UK are living with NMD. Additionally, we will utilise practices in England which have been linked to hospital admissions and mortality data, to further describe the health and healthcare of these patients.
We will estimate the incidence and prevalence of NMD in the UK between 2000-18 by exploiting the longitudinal and historical medical information recorded on the primary care record. Population denominators will be estimated from the registration data of all general practices in the UK contributing data during the study period. A description of regional and social-economic patterns will be provided. We will then describe the health characteristics and healthcare utilisation of patients with NMD, encompassing consultations, referrals and co-morbidities (identified from the primary care record), hospital admissions and mortality (extracted from linked data, England only). Finally, we will create an age-sex-practice matched population sample of patients without NMD in 2015 to compare annual indicators of health and healthcare usage. This will compare recent utilisation in the previous year, and subsequent outcomes (hospitalisations, mortality) up to end of 2018. We will use Poisson regression models to make comparisons between patients with and without NMD across different measures of healthcare utilisation, and Cox regression for mortality.
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Cohort study examining mortality and physical morbidity outcomes among patients diagnosed with an eating disorder — Darren Ashcroft ...
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Cohort study examining mortality and physical morbidity outcomes among patients diagnosed with an eating disorder
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-08
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Cathy Morgan - Corresponding Applicant - University of Manchester
Carolyn Chew-Graham - Collaborator - Keele University
Matthew Carr - Collaborator - University of Manchester
Roger Webb - Collaborator - University of ManchesterOutcomes:
We will estimate incidence rates for all-cause mortality, specific causes of death including natural, unnatural and suicide, non-fatal self-harm, osteoporosis, bone fractures and organ failure (including heart, renal, liver) among patients with and without an eating disorder diagnosis. Cox regression models will be used to estimate adjusted hazard ratios for all-cause mortality, death from specific causes (natural, unnatural and suicide), non-fatal self-harm, osteoporosis, bone fractures and organ failure (heart, renal and liver).
Description: Technical Summary
The aim of the proposed study is to examine whether eating disorders are associated with increased risk of premature death, osteoporosis, fracture and organ failure as well as co-occurring medical conditions and complications such as diabetes, gastro-intestinal problems, substance abuse and psychiatric comorbidities. Using a matched cohort study design, individuals diagnosed with an eating disorder (including anorexia nervosa, bulimia nervosa, binge eating disorder and atypical eating disorder) between 1st January 1998 and 30th November 2018 will be identified using Read, SNOMED and local EMIS codes. Individuals will be eligible for linkage to IMD, HES and ONS mortality records and will have been continuously registered with an up-to-standard general practice for at least one year prior to their diagnosis. Individuals with a diagnosed ED will be extracted and matched on age, gender and practice with up to 20 comparators without a recorded history of eating disorders on the matched individualÂs diagnosed Âindex dateÂ.
Physical and psychiatric health before and after ED diagnosis will be identified, including diabetes mellitus (both type 1 and type 2), gastro-intestinal problems, depression, anxiety disorders, obsessive compulsive disorder (OCD), borderline personality disorder and drug/alcohol misuse. Physical outcomes including osteoporosis and bone fracture, and organ failure, including heart, renal and liver failure will also be identified. All event data will be extracted from contacts through primary and secondary care data sources for individuals with and without an ED. In addition, non-fatal self-harm episodes and alcohol/drug misuse will be identified. Incidence rates will be estimated for all-cause mortality and specific causes of death including natural, unnatural and suicide, non-fatal self-harm and physical health outcomes. Cox regression models, estimating adjusted hazard ratios for each of the fatal and non-fatal adverse outcomes, will indicate whether individuals with ED have elevated morbidity and mortality risk.
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Epidemiology of PagetÂs disease in the UK: Is it still changing? — Terence O'Neill ...
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Epidemiology of PagetÂs disease in the UK: Is it still changing?
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-15
Organisations:
Terence O'Neill - Chief Investigator - University of Manchester
Terence O'Neill - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Michael Cook - Collaborator - University of Manchester
Stephen Pye - Collaborator - University of Manchester
William Dixon - Collaborator - University of ManchesterOutcomes:
Incidence of PagetÂs disease (new clinical diagnoses of PagetÂs disease in GP records); number of GP visits; number of hospital admissions. Also, all-cause mortality, hip and knee arthroplasty and major fractures.
Description: Technical Summary
Our broad aim is to determine temporal and geographic trends in the incidence of clinically diagnosed PagetÂs disease. A secondary aim is to examine health impact including mortality and health care utilisation following clinical diagnosis.
Age-, sex-, geographic- and Index of Multiple Deprivation (IMD)- specific incidence rates will be calculated by dividing the number of new cases by the total person timeof follow-up. This will be calculated as the sum of the number of patients registered in the database on January 1st of each year. Trends in incidence rates over time (grouped into 5 year intervals) will be examined using Poisson regression. We will test for any significant geographic effects on occurrence, and any significant impact of deprivation and whether this is able to explain any observed regional effects.
Health care outcomes and health care utilisation will be characterised using descriptive statistics. Poisson regression will be used to compare health care utilisation between PagetÂs patients and controls, adjusting for age, gender, IMD and comorbidity (Charlson Index). Given the potential that analysis of secondary care contacts may be affected by over dispersion we will analyse this data using a negative binomial model. We will look also at the crude occurrence of significant health outcomes including hip and knee arthroplasty in those with PagetÂs compared to controls.
All cause mortality will be determined using data from CPRD. Participants with PagetÂs disease will be matched to up to 5 controls at the date of PagetÂs diagnosis. Cases will be matched to controls on age, sex, and practice. Survival will be compared between cases and controls using Kaplan-Meir curves. Cox proportional hazards will be used to determine whether there is any excess mortality in those with the disease compared to the controls.
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Trends in gabapentinoid prescribing and risk of adverse events: an observational study in UK primary care using the Clinical Practice Research Datalink — Julie Ashworth ...
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Trends in gabapentinoid prescribing and risk of adverse events: an observational study in UK primary care using the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-29
Organisations:
Julie Ashworth - Chief Investigator - Keele University
Ram Bajpai - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Deborah Hickson - Collaborator - Not from an Organisation
Rebecca Whittle - Collaborator - Keele University
Sara Muller - Collaborator - Keele University
Sarah Harrisson - Collaborator - Keele University
Toby Helliwell - Collaborator - Keele UniversityOutcomes:
Gabapentin and pregabalin prescriptions (Workpackage 1); Serious adverse events (major trauma/falls, drug misuse/addiction, overdose) in patients prescribed gabapentinoids (Workpackage 2 and 3).
Description: Technical Summary
Background
Gabapentin and pregabalin (gabapentinoids) are medications licensed for epilepsy and neuropathic pain. Pregabalin is also licenced for anxiety disorders. Marked year-on-year increases in gabapentinoid prescribing suggest widespread off-label prescribing for other pain conditions, despite limited evidence of effectiveness. Increasing reports of misuse and gabapentinoid-related deaths have resulted in the reclassification of gabapentinoids as controlled drugs. However, most reported adverse events occur in high-risk populations and the risk of gabapentinoid-related adverse events in the wider patient population is unknown.
Aims and Objectives
We will investigate trends in UK gabapentinoid prescribing, including likely indications and determine the risks of and risk factors for major trauma/falls, drug misuse and overdose in primary care patients.
Methods
Work Package 1
We will identify patients aged ?18 years in CPRD practices and issued ?1 gabapentinoid prescription (1997-2019). Repeated cross-sectional analyses will calculate point and period prevalence of gabapentinoid prescribing each year, stratified by age and gender. We will also investigate whether the change in licensing in April 2019 has resulted in a change in incident and prevalent prescribing.
In patients with incident gabapentinoid prescriptions, we will extract information on licensed indications (epilepsy, neuropathic pain, anxiety), chronic pain conditions representing unlicensed indications (expert consensus), and concurrent prescribing (opioids, benzodiazepines, hypnotics, antidepressants). We will identify the proportions with licensed/non-licensed indications and describe therapy dose/duration, prior prescribing pathway and concurrent prescribing.
Work Package2
We will compare patients with incident gabapentinoid prescriptions to patients not prescribed gabapentinoids regarding incidence of major trauma/falls, drug misuse, and overdose.
We will use self-controlled case-series methodology to better account for between-person confounding when investigating adverse events in gabapentinoid users.
Work Package 3
We will assess potential risk factors for adverse events in patients prescribed gabapentinoids, (e.g. socio-demographics, lifestyle factors, comorbidities, co-prescriptions), using multivariable Cox regression to examine associations between potential risk factors and adverse events.
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Global prescribing trends in antidepressants, opioids and lithium — Stephen Weng ...
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Global prescribing trends in antidepressants, opioids and lithium
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-06
Organisations:
Stephen Weng - Chief Investigator - University of Nottingham
Stephen Weng - Corresponding Applicant - University of Nottingham
Adrienne Chan - Collaborator - University of Hong Kong
Barbara Iyen - Collaborator - University of Nottingham
Ian Wong - Collaborator - UCL School Of Pharmacy
Joe Kai - Collaborator - University of Nottingham
Kenneth Man - Collaborator - University College London ( UCL )
Nadeem Qureshi - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
 Prevalence and incidence of antidepressants use
 Prevalence and incidence of opioids use
 Prevalence and incidence of lithium useDescription: Technical Summary
Recent published studies have shown increasing trends in antidepressant, opioids and lithium prescribing, due to the drugs now being used for an increasing number of potential indications. Using electronic health records provided by the Clinical Practice Research Datalink, we will estimate medication prevalence and incidence using data from all patients whose records indicates at least one antidepressant/opioids/lithium prescription from the1st January 2001 to 31st December 2018. The annual prevalence of medication prescribing will be calculated by dividing the total number of individuals prescribed with at least one medication per calendar year by the mid-year total population covered in CPRD. The prevalence will be expressed as a percentage per 100 individuals. The annual incidence of medication prescribing will be calculate by dividing the total number of individuals newly prescribed with at least one of the three medications per calendar year by the mid-year total population that without any prescriptions in that particular year. Each medication will be analysed separately. The incidence will be expressed as a percentage per 100 individuals. Age will be defined by mid-year age and data will be aggregated into one-year age bands.
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Health care demand modelling  Time series analysis of the incidence and prevalence of multiple chronic conditions and comorbidities in England from primary care data — Toby Watt ...
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Health care demand modelling  Time series analysis of the incidence and prevalence of multiple chronic conditions and comorbidities in England from primary care data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-24
Organisations:
Toby Watt - Chief Investigator - The Health Foundation
Andrew Campbell - Corresponding Applicant - The Health Foundation
Ann Raymond - Collaborator - The Health Foundation
Laurie Rachet-Jacquet - Collaborator - The Health Foundation
Stephen Rocks - Collaborator - The Health FoundationOutcomes:
Prevalence and incidence of chronic conditions and combinations of chronic conditions over time. The selected chronic conditions are: heart failure; stroke/transient ischaemic attack; atrial fibrillation; coronary heart disease; diabetes; COPD; hypertension; cancer; asthma; dementia; anxiety; depression; schizophrenia/bipolar disorder; chronic kidney disease; chronic liver disease.
Description: Technical Summary
Our aim is to use CPRD to select patients with no, one or multiple chronic conditions as diagnosed in primary care. Once we have selected patients with these conditions, we will analyse trends in their incidence and prevalence over time.
Our research on chronic conditions will consist of two major areas of work:
1. Categorisation of primary care patients with mutually exclusive chronic conditions and comorbidities. This will draw on existing research that identifies long term conditions using CPRD data
2. Time series analysis on trends of incidence and prevalence of those chronic conditionsFindings from this categorisation and trend analysis will feed into a microsimulation model, or a more standard deterministic projection model, of health care demand and costs which will be outlined in a separate protocol.
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The IMPORTANT Study: Investigating myeloproliferative neoplasms, patient outcomes and treatment of thromboembolic events in the UK — Adrian Paul J. Rabe ...
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The IMPORTANT Study: Investigating myeloproliferative neoplasms, patient outcomes and treatment of thromboembolic events in the UK
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-21
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
Epidemiologic measures (incidence of MPN and its subtypes polycythaemia vera (PV), essential thrombocythaemia (ET) and myelofibrosis (MF), incidence of secondary MF or acute leukaemia, incidence of any other malignancies) mean time to secondary malignancy from MPN diagnosis, demographics and clinical profile (age, sex, ethnicity, index of multiple deprivation, Charlson co-morbidity score, Q risk score, smoking ,dyslipidaemia, hypertension, diabetes, obesity, ischaemic heart disease, peripheral vascular disease, pre-diagnosis thrombosis, blood cell counts), clinical measurements (body mass index, cholesterol level, blood pressure level), clinical outcomes (myocardial infarction, stroke, peripheral arterial disease, deep vein thrombosis, pulmonary embolism, splanchnic vascular thrombosis, rare site venous thrombosis, migraine, vascular dementia, erythromelalgia)
Description: Technical Summary
MPNs are a group of neoplasms where there is proliferation of specific blood cell lines, including erythrocytes (polycythaemia vera or PV), platelets (essential thrombocythaemia or ET) or marrow fibroblasts (myelofibrosis or MF). The aetiology of MPNs is still to be fully elucidated and may be related to previous chemotherapy for a primary malignancy, or the occurrence of mutations in the progenitor cells of those blood cell lines resulting in increased cell production.
Because of the massive increase in cell mass within the circulation, there is an increased risk of blood cell shear stress resulting in clumping and clot formation. These thromboembolic events mimic conditions which also result in arterial vascular occlusions, including stroke and myocardial infarction. In MPNs, there is also an increased risk in venous occlusions, resulting in splenic vein thrombosis, cerebral sinus thrombosis and other similar conditions.
As the risk factors for Âtraditional cardiovascular conditions are managed at a primary care level, GPs are increasingly burdened with the care of MPNs despite disease complexity and the need for speciality care. These risk factors include smoking, hypertension, hyperglycaemia and diabetes, and dyslipidaemia.
Our study would like to first assess the epidemiological burden that MPNs and their PV, ET and MF subtypes impose in the UK through a descriptive retrospective single cohort study using CPRD, a clinical dataset for primary care. We would then determine their risk factor profile and demographic characteristics. In order to further elucidate the clinical pathway, we plan to measure thromboembolic events occurring after the diagnosis of MPNs or their subtypes. Finally, we would like to determine whether treatment for risk factors for thromboembolic events was initiated by GPs.
Through our study we hope to gain a clearer understanding of MPNs in the UK and how clinical pathways in primary care can better serve afflicted patients.
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Polypharmacy and the impact of drug interactions with direct oral anticoagulants (DOACs) — Yun "Angel" Wong ...
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Polypharmacy and the impact of drug interactions with direct oral anticoagulants (DOACs)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation (index other than the most recent)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-02
Organisations:
Yun "Angel" Wong - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amitava Banerjee - Collaborator - University College London ( UCL )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Esther Chan - Collaborator - University of Hong Kong
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Wong - Collaborator - UCL School Of Pharmacy
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcomes (cardiovascular effectiveness endpoints): ischaemic stroke, myocardial infarction, venous thromboembolism and cardiovascular death.
Secondary outcomes (safety endpoints): intracranial and/or gastrointestinal bleeding, other-bleeding and all-cause mortality.
Description: Technical Summary
The aim of this study is to explore patterns of polypharmacy and to quantify the health consequences of drug interactions with direct oral anticoagulants (DOACs). We will focus on drugs which potentially interact with DOACs but currently have conflicting mechanistic and epidemiological evidence including amiodarone, dronedarone, verapamil, diltiazem, digoxin, cyclosporine, simvastatin, lovastatin, atorvastatin, erythromycin, clarithromycin, ketoconazole, itraconazole, voriconazole, posaconazole. We will also investigate the benefits and risks of using proton pump inhibitors (PPIs) to prevent DOAC-related gastrointestinal bleeding.
We will identify new DOACs and warfarin users, aged 18 or above during 1/1/2011-31/07/2019 using the data from the Clinical Practice Research Datalink. We will describe the patterns of co-prescribed medications and polypharmacy among oral anticoagulant users. We will then use a cohort study with propensity score and case-crossover study design to investigate if 1)DOACs are associated with interactions with the drugs of interest); 2)whether DOACs have a lower risk of drug interactions compared with warfarin; 3)whether concurrently receiving PPIs and DOACs reduces risk of bleeding without affecting the risk of cardiovascular and mortality outcomes. Outcomes will be cardiovascular events, bleeding and mortality.
Using cohort study design, we will identify the exposed group (DOAC with the concomitant drug/PPIs) and three comparison groups (DOAC alone; warfarin with the concomitant drug/PPIs; warfarin alone). Propensity score methods will be used to control for confounding. We will compare the hazards of each outcome among the exposed group with each comparison group using Cox proportional-hazard regression.
Using modified case-crossover study design, we will identify patients with each outcome who were exposed to at least one of the two interacting drugs (oral anticoagulants and the concomitant drug/PPIs). We will compare each patientÂs exposure in a time period prior to the outcome (hazard window) to that during a control period (referent window) within an individual using conditional logistic regression.
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Cardiovascular risk and outcomes in the UK population before and after cancer treatment: a cohort study — Umesh Kadam ...
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Cardiovascular risk and outcomes in the UK population before and after cancer treatment: a cohort study
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS National Radiotherapy Dataset (RTDS) data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-10-08
Organisations:
Umesh Kadam - Chief Investigator - University of Leicester
Umesh Kadam - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
David Adlam - Collaborator - University of Leicester
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kamlesh Khunti - Collaborator - University of Leicester
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Lucy Teece - Collaborator - University of Leicester
Michael Sweeting - Collaborator - University of Leicester
Paul Lambert - Collaborator - University of Leicester
Richard Holland - Collaborator - University of LeicesterOutcomes:
Hospital admissions; Mortality; Cardio-metabolic diseases; Cardiovascular diseases; Cerebrovascular diseases; Cancer
Description: Technical Summary
Background: In ageing populations who are living longer and with effective treatment of adult cancers means cancer survivors, means there are increasing numbers who have both cardiovascular disease and cancer. However, there is little evidence on the population level cardiovascular risk or disease status at the point of adult cancer diagnosis and how cancer treatment affects longer-term outcomes in common cancer specific populations.
Design: Retrospective cohort design.
Methods: The CPRD Gold and Aurum datasets linked to National Cancer Registration and Analysis Service, Hospital Episode Statistics (HES) and ONS death data will be used to identify adults aged 40 years and over with four common cancers (breast, prostate, gastrointestinal tract and lung) and compared to matched non-cancer cohorts. In four phases, there will be assessment of: (i) baseline cardiovascular risk factors at cancer diagnosis and change in risk factors following cancer diagnosis using longitudinal mixed models, (ii) risk of cardiovascular outcomes at 1, 3 and 5 years using flexible parametric survival models, (iii) cardiovascular risk score at baseline and development of a cancer-specific CVD risk score and (iv) estimation of population attributable fractions for modifiable risk factors.
Outcomes: This investigation will (i) determine cardiovascular risk factors, disease status and outcomes in populations with four common cancers, (ii) develop prognostic risk scores for assessing CVD risk in cancer populations and (iii) identify modifiable CVD risk factors at and after cancer treatment. Such evidence will be crucial in devising public health policies which incorporate routine CVD risk monitoring to develop new tailored risk assessments for an increasing adult population of cancer survivors.
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Does North West London primary care diabetes provision vary by social group? A historical cohort study — Imperial College Healthcare NHS Trust...
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Does North West London primary care diabetes provision vary by social group? A historical cohort study
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Oct-19
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Type 2 Diabetes. Academic
Source
2019 - 09
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The Impact of Exacerbation Burden on Lung Function Trajectory in a Broad Asthma Population — David Price ...
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The Impact of Exacerbation Burden on Lung Function Trajectory in a Broad Asthma Population
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-26
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Shay Soremekun - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Derek Skinner - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jaco Voorham - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Trung Tran - Collaborator - Astra Zeneca Inc - USAOutcomes:
Two outcomes will be measured:
Mean change in FEV1 over follow up period (ml in 1 second/year); Mean change in PEFR over follow up period (ml/year).Description: Technical Summary
Rationale: Progressive worsening of lung function (LF) may contribute towards the development of severe asthma. Evidence suggests that asthma exacerbations may be associated with poorer LF over time.
However only a small number of studies have looked specifically at the association between exacerbation burden and LF decline in asthma patients, with mixed results. Short follow-up times, restrictions to subgroups of asthma patients, and varied methodology will have contributed to the lack of clarity in the available evidence.Aim: This study aims to investigate if there is an association between exacerbation burden and lung function decline in a broad asthma patient population using longitudinal real-life data collected on a large scale.
Design: This is an historical cohort study combining data from CPRD and Optimum Patient Care UK. The cohort will be patients diagnosed with asthma, with ?3 LF readings of the same type (peak expiratory flow [PEFR] or forced expiratory volume in 1 second [FEV1]) on or after their 18th birthday, and ?5 years of eligible LF data. The index date (start of follow up) will be the date on which the first eligible LF reading is recorded.
Exposure and outcomes: The primary exposure will be exacerbation burden, defined as i) annual rate of exacerbations, ii) number of years with exacerbations/total follow-up years, and iii) cumulative number of exacerbations. Exacerbations resulting in hospital visits will be linked using Hospital Episode Statistics (HES) data. The outcomes will be lung function trajectory (slope) measured using i) PEFR and ii) FEV1.
Analysis: Exacerbation burden will be the main exposure in a mixed effects linear regression model. Variation in lung function trajectories between patients is accounted for by including a random intercept and slope of lung function over time at the patient level in the model. Models will adjust for relevant confounders where appropriate.
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A retrospective, non-interventional, descriptive study to define the rate of adverse events in subjects with various stages of chronic kidney disease — Dustin Little ...
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A retrospective, non-interventional, descriptive study to define the rate of adverse events in subjects with various stages of chronic kidney disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-04
Organisations:
Dustin Little - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Alyshah Abdul Sultan - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Glen James - Collaborator - Astra Zeneca Ltd - UK Headquarters
Matthew Arnold - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ping Sun - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
All-cause mortality and adverse events. We will specifically study the following adverse events:
 Infection/sepsis events
 Urinary tract infection events
 Gastrointestinal haemorrhage events
Hypoglycemia events
 Pancreatitis events
 Thyroid events
 Acidosis
 Hyperkalemia
 Rhabdomyolysis
 Tachycardia events
 Pneumonia and lower respiratory infection events
 Hepatic events
 Seizure events
 Retinal events
 Allergic and anaphylaxis events
 Severe cutaneous adverse reactions
 Pure red cell aplasia
 Deep vein thrombosis
 All cause mortalityDescription: Technical Summary
Objectives
Advanced CKD is associated with anaemia which can lead to adverse consequences. Roxadustat is one of several hypoxia inducible-factor prolyl hydroxylase inhibitors (HIF PHI) in late-phase clinical development for the treatment of anaemia secondary to chronic kidney disease (Gupta and Wish, AJKD 2017). These programs are powered to assess the cardiovascular safety of HIF PHIs versus comparator. However, data on the risk of rare events is likely to be inconclusive. Our proposed study aims to facilitate the development and delivery of innovative therapies and treatment strategies, to patients, by characterising rates for events of interest, in populations with baseline CKD of varying severity.Specific objective:
1. Describe baseline characteristics of CKD patients and stratify these by disease severity (estimated glomerular filtration rate (eGFR) stage) and dialysis status.
2. Quantify the risk of all-cause mortality and adverse events in patients with CKD after diagnosis.
3. Stratify the risk of adverse events by CKD stage and dialysis status.Methods and analysis plan
We will study individuals with recorded diagnosis of CKD between 2004 and 2019 in CPRD linked to Hospital Episode Statistics (HES) data. For each patient, serum creatinine values will be extracted and eGFR will be calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. CKD will be defined using two consecutive measurements of (eGFR) < 60 mL/min/1.73m2 recorded at least 3 months apart. Information on baseline characteristics (age, gender etc.) and pre-specified adverse events (e.g. pancreatitis, cardiovascular events, tachycardia) will be extracted using both primary and secondary care data. Office of National Statistics (ONS) mortality data will be used to better ascertain deaths. Baseline characteristics will be summarised using descriptive statistics. Incidence rate will be calculated by dividing the total number of adverse events by person-years of follow-up. We will stratify these estimates by disease severity.
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Treatment, Complications, and Costs in Clavicle Fracture and Acromioclavicular Dislocation — Abhishek Chitnis ...
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Treatment, Complications, and Costs in Clavicle Fracture and Acromioclavicular Dislocation
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-25
Organisations:
Abhishek Chitnis - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Abhishek Chitnis - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Chantal Holy - Collaborator - Johnson & Johnson ( JnJ - USA )
Charisse Sparks - Collaborator - Johnson & Johnson ( JnJ - USA )
Cindy Tong - Collaborator - Johnson & Johnson ( JnJ - USA )
Simon Lambert - Collaborator - University College London Hospitals
Simone Wolf - Collaborator - Synthes GmbH
Thibaut Galvain - Collaborator - Johnson & Johnson Medical SASOutcomes:
This is a descriptive study and the key variables of interest include surgical treatment of clavicle fractures and AC dislocation; infection, non-union, mal-union and reoperations associated with surgical treatment of clavicle fracture and AC dislocation; healthcare costs for patients with clavicle fracture and AC dislocation surgery
Description: Technical Summary
Clavicle fractures are common fractures that result from direct or indirect trauma to the shoulder region. Criteria for nonsurgical or surgical management of clavicle fractures are not clearly established. AC dislocation is a common shoulder injury typically due to direct trauma. Minor injuries (Types I and II) are typically managed nonoperatively, and more severe injuries (Types IV, V, and VI) are often referred to an orthopedic specialist for surgical consideration. Whether surgery is indicated for Type III AC joint injuries remains controversial. Data regarding the clinical and economic burden and treatment pathways and outcomes associated with clavicle fractures and AC dislocation is sparse. This study will assess rates of surgical treatment, post-surgical complications (infection, non-union, mal-union), reoperations, and reimbursement in patients with clavicle fractures and AC dislocations. Patients with ?1 diagnosis of clavicle fracture or AC dislocation (index) between 2010-2017 will be identified. Surgical treatment will be defined as a procedure within four weeks after clavicle fracture or AC dislocation. Rates of complications (infection, non-union, mal-union) and reoperations among surgical patients will be evaluated two years post-index. Reoperations will be defined as device-related e.g. removal of implant(s), or fracture or dislocation-related e.g. revision surgical procedures. All-cause healthcare costs will be evaluated over the two-year follow-up for surgical patients.
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Evaluation of the survival, treatment pathways and liver disease outcomes of patients with liver disease and their progression to cirrhosis and hepatic encephalopathy: a non-interventional study using primary and secondary healthcare data from the UK — Craig Currie ...
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Evaluation of the survival, treatment pathways and liver disease outcomes of patients with liver disease and their progression to cirrhosis and hepatic encephalopathy: a non-interventional study using primary and secondary healthcare data from the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-04
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
- Collaborator -
Luke Saunders - Collaborator - Harvey Walsh Ltd
Matthew O'Connell - Collaborator - Harvey Walsh LtdOutcomes:
 Mortality
 Decompensating events such as HE
 Treatment pathways
 Referral patternsDescription: Technical Summary
The objective of this study is to better understand the how patients with liver disease experience healthcare by assessing treatment pathways, referral patterns by examining three populations of increasing liver disease severity; liver disease, cirrhosis and hepatic encephalopathy (HE). We plan to describe the characteristics, and comorbidities of these cohorts overall and split by treatment groups; no treatment recorded, rifaximin, lactulose, and combined rifaximin and lactulose. We also aim to identify the impact that Rifaximin and lactulose treatments have on the risk of mortality in the HE group.
Referral patterns will be investigated using the clinical and referral table within Clinical Practice Research Datalink (CPRD) and the linked Hospital Episode Statistics (HES) data to categorise clinical visits, inpatient admissions, outpatient appointments and emergency admissions to investigate patients disease journey within the UK heath service.
Mortality risk in patients will be investigated using time dependent cox regression models adjusting for treatment and associated decompensating events.
Patients within the four severity populations will be identified by:
Liver disease  identified by the first diagnosis of a liver related code within CPRD & HES identified from Read codes, OPCS and ICD-10 codes in CPRD GOLD and Aurum or prescriptions for Rifaximin 550mg
Cirrhosis identified by the earliest diagnosis code for cirrhosis from within the liver disease population cohort identified by Read code, OPCS, ICD-10 codes in CPRD GOLD and Aurum.
Hepatic encephalopathy - identified from within the liver disease population with a Read code for HE or a Rifaximin 550mg prescription or both a Rifaximin 200mg prescription and a liver disease code.
Predicted Hepatic encephalopathy  (e.g. identified from Tapper et al.9 risk equation (only if validated in UK data)).
Patients will be identified post 2003 and must be of at least 18 years of age and of CPRD acceptable standard.
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Data analysis of the current treatments for major depressive disorder and treatment resistant depression in Scotland — Timothy Ming ...
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Data analysis of the current treatments for major depressive disorder and treatment resistant depression in Scotland
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-10
Organisations:
Timothy Ming - Chief Investigator - Janssen Pharmaceuticals UK
Timothy Ming - Corresponding Applicant - Janssen Pharmaceuticals UK
Gemma Scott - Collaborator - Janssen Pharmaceuticals UK
Joachim Morrens - Collaborator - Janssen-Cilag Ltd
Joris Diels - Collaborator - Janssen Pharmaceutica NV
Timothy Ming - Collaborator - Janssen Pharmaceuticals UK
Tom Denee - Collaborator - Janssen Pharmaceuticals UKOutcomes:
Incidence of MDD; Incidence of TRD; Treatment patterns (treatments prescribed, dose prescribed, treatment dynamics and number of lines of therapy received); Baseline demographics (age, sex, region, ethnicity); Clinical characteristics (number of episodes, episode type, TRD diagnosis and comorbidities); Treatment outcomes (relapse, recovery, recurrence, remission and response);
Description: Technical Summary
Objectives:
This study aims to better understand the epidemiology of MDD and TRD and the current treatment pathways used in the treatment of these conditions in Scotland which will in turn allow Janssen to ascertain whether there is a specific unmet need within these patient groups regarding the treatment options currently available, and thus highlighting the need for new treatments. The results of this study will also be used to inform a submission to a UK Health Technology Assessment (HTA) body to determine the relevance of currently-available comparators.
Methods:
To address the study objectives, a retrospective, longitudinal cohort design will be employed in incident MDD patients identified between January 2011 and May 2018 using CPRD data. Patients will be indexed on the date of first AD prescription within the indexing period and all indexed patients will be followed up for a minimum of 180 days, with the exception of those who die in the 180 days following indexing.
Data analysis:
All analyses will be predominantly descriptive in nature, with all outcomes reported using appropriate descriptive statistics. Statistical testing will be utilised between subgroups, where applicable, in addition to Kaplan-Meier estimates (for time-to-event analyses) and generalised linear models (for regression modelling). Analyses pertaining to the primary and secondary objectives will include estimation of incidence of MDD and TRD, description of treatment pathways and treatment outcomes at each line of therapy and description of baseline demographics and clinical characteristics.
Source -
Cancer risk in transgender individuals — Meredith Shiels ...
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Cancer risk in transgender individuals
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-08
Organisations:
Meredith Shiels - Chief Investigator - National Cancer Institute ( NCI )
Sarah Jackson - Corresponding Applicant - National Cancer Institute ( NCI )
Alison Berner - Collaborator - Tavistock and Portman NHS Foundation Trust
Britton Trabert - Collaborator - National Cancer Institute ( NCI )
Duncan Shrewsbury - Collaborator - Brighton and Sussex Medical School
Jalen Brown - Collaborator - National Cancer Institute ( NCI )
Ruth Pfeiffer - Collaborator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Collaborator - National Cancer Institute ( NCI )
Stewart OâCallaghan - Collaborator - Live Through ThisOutcomes:
The primary outcome of interest is all cancers combined and cancers by anatomic sites; the secondary outcomes of interest are to estimate the prevalence of cancer risk factors (obesity, smoking, problem drinking, diabetes mellitus, cirrhosis, HIV, hepatitis virus infection, and hormonal mediations) in the population. The tertiary outcome of interest is all-cause and cancer-specific mortality. Finally, we would like to assess adherence to recommended cancer screenings and compare outcomes for cervical, colon, and endometrial screenings between transgender and cisgender patients.
Description: Technical Summary
Transgender is the catchall term for individuals whose gender expression (masculine, feminine, other) differs from their birth sex (male, female). Gender dysphoria refers due to an individualÂs discomfort with the incongruence between their experienced gender identity and assigned sex at birth. Some transgender individuals take hormones or undergo gender confirmation surgery so that their outward gender expression matches their internal gender identity. In the UK, approximately 21 in 100,000 persons over the age of 15 are transgender.
Cancer risk is an understudied topic in transgender health due to paucity of available data. Until recently, research on cancer in this population has been limited to a few case reports. Two previous studies have used US cancer registry data to examine cancer distribution by primary site in the US transgender population. Both studies found a higher proportion of certain cancers in this population compared to cisgender individuals, including virally-related and AIDS-defined malignancies. However, these studies were not able to estimate cancer rates or identify risk factors in the transgender population due to lack of denominator data.
There is an urgent need to expand our knowledge of cancer risk among transgender individuals as the population grows and ages. This study will quantify cancer risk among transgender persons, an understudied population with an increased burden of cancer risk factors. We will use the CPRD to identify a cohort of transgender patients with diagnostic codes for gender dysphoria and match them to a cohort of cisgender patients. Our analyses will quantify overall and site-specific cancer risk among transgender patients and will identify risk factors for the development of these cancers. Analyses will be adjusted for common cancer risk factors (smoking history, BMI, and alcohol use). This information can help inform screening guidelines and prevention efforts, which will become increasingly important as the population ages.
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What care is currently provided in the NHS for people with coeliac disease and what does it cost? — Joe West ...
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What care is currently provided in the NHS for people with coeliac disease and what does it cost?
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-25
Organisations:
Joe West - Chief Investigator - University of Nottingham
Lu Ban - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Denise Kendrick - Collaborator - University of Nottingham
Manpreet Bains - Collaborator - University of Nottingham
Mara Violato - Collaborator - University of OxfordOutcomes:
Health service utilisation and associated cost
Description: Technical Summary
Coeliac disease is a chronic disease of the gut. The only available treatment is a lifelong exclusion of gluten from daily diet. Management can be tricky, with some individuals experiencing significant interference with everyday life.
Approximately 200,000 people in the UK have been diagnosed with coeliac disease and the incidence is increasing. High quality and appropriate long-term management of this condition is crucial, however currently no good evidence exists to shape guidelines that can meaningfully improve the day-to-day lives of people with coeliac disease.Despite this worrying lack of evidence, the National Institute for Health and Care Excellence (NICE) and
gastroenterology societies have published national guidelines about long term follow up of people with coeliac disease. These recommend offering a single strategy for all consisting of yearly face-to-face check-ups with a health care professional. However, only about half of people with coeliac disease attend these currently.
Increasing attendance would mean a large amount of extra money would need to be spent by the NHS on a service for which there is minimal evidence that it would improve lives. Instead those resources could be used to
provide a personalised suite of services that better matches the individuals needs and preferences, and maximises patients' health related quality of life.The overall aim of the project therefore is to underpin future economic models and clinical trials to ensure optimal long-term follow-up for people with coeliac disease in the NHS. Specifically, this study is to describe and quantify what care is currently provided in the NHS for people with coeliac disease and to quantify what it currently costs the NHS to provide follow-up services for people with coeliac disease.
We will use the Clinical Practice Research Datalink to identify a large group of people diagnosed with coeliac
disease and determine what long-term follow-up care is being provided in the NHS today and how much it costs. We will also quantify any socio-demographic inequalities in care provision that exist.
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Hypertensive disorders of pregnancy and risk of cardiovascular disease in women: electronic cohort study in primary care — Shantini Paranjothy ...
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Hypertensive disorders of pregnancy and risk of cardiovascular disease in women: electronic cohort study in primary care
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-10
Organisations:
Shantini Paranjothy - Chief Investigator - University of Aberdeen
Harry Ahmed - Corresponding Applicant - Cardiff University
Hywel M. Jones - Collaborator - Cardiff University
Laszlo Trefan - Collaborator - University of Manchester
Sohinee Bhattacharya - Collaborator - University of AberdeenOutcomes:
Outcomes of interest are indicators of new-onset cardiovascular disease (CVD) that occur after a completed pregnancy in a cohort of women who have no evidence in their GP record to suggest a history of CVD prior to pregnancy. The specific outcomes are:
1. Hypertension
2. Ischaemic heart disease
3. Cerebrovascular diseaseDescription: Technical Summary
Preeclampsia affects 4 to 8% of pregnancies. It is a multi-system disorder that can affect subsequent (post-pregnancy) cardiovascular health and is associated with an increased risk of cardiovascular events and mortality. However, the existing evidence base is largely based on hospital admissions data, thus limiting its use for insights into opportunities for early detection and intervention to alter disease progression. Currently, very little is known about the timing of adverse cardiac events in women who have had hypertensive disorders of pregnancy, or the effect of lifestyle modification on their development.
This proposal is a retrospective cohort study that seeks to address these gaps in the evidence by analysing CPRD data to estimate the risk and time to onset of incident cardiovascular disease in women who have hypertensive disorders of pregnancy, to inform subsequent strategies for cardiovascular risk assessment and screening in primary care settings. Outcomes of interest are indicators of new-onset cardiovascular disease (hypertension, ischaemic heart disease and cerebrovascular disease) that occur after a completed pregnancy, in a cohort of women who have no evidence in their GP record to suggest a history of cardiovascular disease prior to pregnancy. We will identify the socio-demographic and clinical variables associated with these disorders and estimate the risk of incident cardiovascular disease in women with a hypertensive disorder of pregnancy compared to women without, accounting for socio-demographic and clinical risk factors.
The outputs from this project will contribute towards developing a targeted approach using routine data for risk stratification for women who have had hypertensive disorders of pregnancy to assess their cardiovascular risk.
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Utilization of routinely performed diagnostic tests in primary care — Susan Jick ...
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Utilization of routinely performed diagnostic tests in primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-05
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Cornelia Schneider - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of BaselOutcomes:
Frequency of and recorded results per person and per year of the major routinely performed diagnostic blood tests (see definition below in section N)
Description: Technical Summary
Most routine lab diagnostics were developed to detect a specific disease, but now are often performed during routine health checks or in patients with ill-defined symptoms. The interpretation of these test results poses a challenge in patient care, as normal values and acceptable deviations from the norm are not well defined or understood. We plan to study all CPRD GOLD patients aged 40-79 years present in the data between January 1, 2004 and December 31, 2017 to describe the utilization of major routine blood tests such as lipid and glucose levels, liver or thyroid function tests and blood cell counts. Using descriptive statistics such as mean and standard deviation, range and percentiles, we will quantify the frequency of testing per year during the study period and describe the distribution of measured lab values for the different lab tests parameters in this middle-aged adult primary care population. We will provide this information for the whole study population, as well as for subgroups stratified by age, sex and prevalent underlying metabolic or cardiovascular diseases.
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Incidence of adverse effects related with long-term use of paracetamol: a propensity score matched cohort study. — Weiya Zhang ...
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Incidence of adverse effects related with long-term use of paracetamol: a propensity score matched cohort study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-11
Organisations:
Weiya Zhang - Chief Investigator - University of Nottingham
Jaspreet Kaur - Corresponding Applicant - University of Nottingham
Abhishek Abhishek - Collaborator - University of Nottingham
Christian Mallen - Collaborator - Keele University
Georgina Nakafero - Collaborator - University of Nottingham
Michael Doherty - Collaborator - University of NottinghamOutcomes:
Primary outcome: incidence rate of gastro-intestinal adverse events (namely perforation, peptic ulcer, upper/lower gastrointestinal bleeding separately and as a composite outcome) in the risk measure of per 1000 person-years.
Secondary outcomes: incident rate Cardiovascular events, incident rate chronic kidney disease and mortality
Description: Technical Summary
Background
The recent NICE-guideline on OA (2014) suggests that benefits of paracetamol are comparatively low and the adverse effects it can cause in long-term usage are more common than were thought previously [1].Aims
This research aims to analyse the association of paracetamol with gastrointestinal events (such as perforation, peptic ulcer, upper and lower gastrointestinal bleeding), cardiovascular events (hypertension, myocardial infarction, haemorrhagic and ischaemic stroke), chronic kidney disease and all-cause mortality with a long follow-up period of upto 20years using primary healthcare records.Methods
The eligible people must be aged 65years or older, registered with the up-to-standard practices for at least 12months. The paracetamol users are defined as participants who receive at least two prescriptions of paracetamol from their GPs within 6months. The first prescription date will be the index date. We will match each user with non-user according age, gender and propensity-score. Non-users are the participants who do-not receive two paracetamol prescriptions within 6 months over the study period. The same index date will be assigned for user and the matched non-user.Statistical analysis
The propensity score will be calculated using the logistic-regression model. The likelihood of receiving paracetamol will be the dependent variable and smoking, alcohol consumption, comorbidities and analgesic use will be independent variables. The follow-up will start 12months after the index-date (landmark-date to avoid miscounting any outcome prior to the qualification as a paracetamol-user). This will provide an exposure window between the index-date and landmark-date to accumulate number of prescriptions and doses for a dose-response analysis.
Participants will be followed-up until the first incidence of outcome of interest, deregistration from the practice, death or end of the study whichever comes first. Kaplan-Meier-curves will be used to estimate the cumulative probabilities of the outcomes. We will use cox-proportional hazard regression to calculate the hazard ratio.
Source - and 12 more projects — click to show
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The Prevalence of Clostridioides difficile Infections (CDIs) in Age- and Comorbidity-Based Risk Groups in England: The PERFECT Study — Adrian Paul J. Rabe ...
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The Prevalence of Clostridioides difficile Infections (CDIs) in Age- and Comorbidity-Based Risk Groups in England: The PERFECT Study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-25
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Gulsah Akin Unal - Collaborator - Health iQ
Gulum Alamgir - Collaborator - Health iQ
James Tilbury - Collaborator - Health iQ
Jay Were - Collaborator - Health iQOutcomes:
Prevalence of CDI; Prevalence of recurrence; Prevalence of co-morbidities in the cohort (IBD, CKD, DM, CA); Demographics (Mean and median age on inclusion, age distribution by decade, percent males, deprivation, mean and median follow-up, total and mean admitted time, prevalence of CKD within the cohort, prevalence of Heart Failure within the cohort, prevalence of COPD within the cohort); Healthcare resource outcomes (prescriptions issued in primary care, procedures in secondary care, total appointments and cost in primary care, outpatient appointments, A&E attendances, inpatient admissions, inpatient length of stay, inpatient HRG tariffs, prior hospitalisation); Clinical outcomes(mortality, destination after discharge, severity of the CDI)
Description: Technical Summary
There has been a dramatic increase in the incidence of CDI in many countries including the UK in recent years despite guidelines such as restricting the use of certain antibiotics aimed at stemming this increase. With current advancements in vaccine research, there is hope that CDI can be prevented in the most at risk groups which would in turn reduce the morbidity, mortality and health care costs associated with them. However, there is limited understanding of the most at risk groups which would affect the potential of targeted preventive methods such as vaccines if they are to be made available on the NHS. There is also a limited availability of knowledge on the prevalence of CDI based on where it is acquired I.e. in the community or hospital and recurrence.
This study aims to differentiate between community and hospital acquired infections by calculating prevalence based on point of acquiring the infection. This will be done by creating two cohorts from the general CDI population by defining community and hospital acquired infections using NHS definitions translated into ICD-10 and OPCS-4 codes.
We shall describe the two cohorts in terms of patient demographic characteristics, prevalence of comorbidities and selected risk factors. Health care resource usage for each cohort will be calculated and reported for inpatient admissions, outpatient, A&E attendances, and primary care appointments. Demographics and health care resource usage for recurrent CDI will be calculated and presented. Outcomes will be described as total, means, medians, percentage or rates as appropriate.
Adjusted and unadjusted odds ratios along with 95% confidence intervals will be calculated for mortality, hospital admission, subsequent CDI morbidity and destination on discharge on comparing each cohort to matched controls. We shall adjust for age, sex and any other risk factors that we may identify as having an effect on the dependent variables.
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Burden of pneumococcal disease and pneumococcal vaccination in adults with underlying medical conditions in the UK — Kelly Johnson ...
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Burden of pneumococcal disease and pneumococcal vaccination in adults with underlying medical conditions in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-18
Organisations:
Kelly Johnson - Chief Investigator - Merck & Co., Inc.
Kelly Johnson - Corresponding Applicant - Merck & Co., Inc.
Bayad Nozad - Collaborator - Merck Sharp & Dohme - UK
Ian Matthews - Collaborator - Merck Sharp & Dohme - UK
Qian Xia - Collaborator - Not from an OrganisationOutcomes:
Pneumococcal VCR in adults aged 18 years onwards with underlying medical conditions; incidence rate of pneumococcal diseases in adults aged 18 years onwards with underlying medical conditions; healthcare resource utilization (i.e. general practice visit, prescription, cost)
Description: Technical Summary
The risk of pneumococcal disease in individuals with underlying medical conditions is not well characterized in the UK. The UK currently recommends pneumococcal vaccination for certain ÂAt Risk adult individuals. However, reports on vaccine coverage rates (VCR) for this population are very limited. The last uptake rate for pneumococcal vaccination in the UK was published in 2009 and only showed a vaccine coverage rate of 34.4%. The primary objective of this study is to estimate the clinical and economic burden of pneumococcal disease and examine the pneumococcal VCR in adults aged 18 to 64 years old with underlying medical conditions using 2011-2016 Clinical Practice Research Datalink (CPRD) data. This retrospective cohort study will be conducted using anonymized electronic health record (EHR) data from 2011-2016. Individuals aged between 18 and 64 years old within the specified clinical risk groups recommended for pneumococcal vaccination in the UK will be included if they had continuous EHR data for 24 months before and at least 12 months after the diagnosis of the underlying medical conditions. Descriptive statistics including frequencies and percentages for categorical variables, mean (SD) for continuous variables, will be calculated. Rates and rate ratios of pneumococcal diseases will be reported among patients with each chronic condition compared with age-matched healthy counterparts; rate of pneumococcal vaccination will be reported among patients with each underlying condition by length of follow-up since diagnosis (ranging from 1 to 4 years). The number and proportion of patients utilizing healthcare resources (i.e. number of physician visits, prescriptions, and treatment costs) will be described. Multivariable logistic regression to determine factors associated with pneumococcal polysaccharide vaccination.
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Patient pathway and therapeutic inertia in newly diagnosed T2DM patients with multimorbidity — Francesco Zaccardi ...
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Patient pathway and therapeutic inertia in newly diagnosed T2DM patients with multimorbidity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-26
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Yogini Chudasama - Corresponding Applicant - Leicester Diabetes Centre
Briana Coles - Collaborator - University of Leicester
Christian Hvid - Collaborator - Novo Nordisk
Clare Gillies - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Sophia Abner - Collaborator - University of LeicesterOutcomes:
Part 1:
 time to event: fatal/non-fatal cardiovascular event; all-cause mortality; cardiovascular-related mortality
 1st line therapies, 2nd line therapies, 3rd line therapies, etc.
 time to treatment initiation
 time to treatment intensification
 consultation rates
 estimated health care costsPart 2:
 treatment intensification
 treatment pathway (1st line therapy, 2nd line therapy, 3rd line therapy, etc.)
 HbA1c control
 transition from an oral glucose-lowering medications to insulin or other injectable glucose-lowering medication
 early lines of therapyDescription: Technical Summary
In the UK, the National Institute for Health and Care Excellence (NICE) provides guidance for the care and management of type 2 diabetes (T2DM) in adults (aged 18 and over). The guideline, NG28, focuses on educating patients on physical activity and dietary considerations as a first point of intervention, and then intensifies to managing cardiovascular risk, blood glucose levels, and long-term complications through progressively stronger therapeutic regiments. However, the uptake of these guidelines in the real-world primary care setting is unknown. It is also unknown whether additional comorbidities affect a patient's therapeutic pathway. Therefore, in the first part of this study, we want to determine the prevalence of comorbidities in patients with T2DM and describe how comorbidities affect primary care resource utilisation and costs, outcomes, and glucose lowering treatment pathways. We will use data collected in primary and secondary care for a cohort of patients w ith a first recorded T2DM diagnosis during 01/01/2000-31/12/2018.
Therapeutic inertia is the failure to establish appropriate targets and escalate treatment to achieve treatment goals. There is a gap in understanding what factors drive therapeutic inertia in patients with T2DM. Therefore, in the second part of this study, we will examine potential points of therapeutic inertia, determine drivers of treatment intensification, as well as identify factors that impact the early lines of glucose lowering therapy for patients with T2DM. We will use time to event flexible parametric modelling to examine factors associated with therapeutic inertia, treatment intensification, and early lines of therapy.
Source -
Effectiveness of BISOprolol on high blood PRESSure versus other ?-blockers, and versus other anti-hypertensive classes. A cohort study in the UK Clinical Practice Research Datalink (CPRD) — Caroline Foch ...
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Effectiveness of BISOprolol on high blood PRESSure versus other ?-blockers, and versus other anti-hypertensive classes. A cohort study in the UK Clinical Practice Research Datalink (CPRD)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-18
Organisations:
Caroline Foch - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Caroline Foch - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Arthur Allignol - Collaborator - Merck Healthcare KGaA (Merck Group)
Emmanuelle Boutmy - Collaborator - Merck Healthcare KGaA (Merck Group)
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)
Ulrike Gottwald-Hostalek - Collaborator - Merck Healthcare KGaA (Merck Group)Outcomes:
Primary outcomes: Average systolic blood pressure (BP) variation; Average diastolic BP variation.
Secondary outcomes: Controlled BP state; Uncontrolled BP state; Type 2 diabetes mellitus (T2DM); Dyslipidaemia; Erectile dysfunction; Obesity; average variation between the body mass index (BMI) at index, and the BMI at one year; hyperglycaemic event.
Description: Technical Summary
This study will focus on newly hypertensive patients. And among them, on patients newly treated with an antihypertensive treatment in monotherapy.
Five exclusive cohorts will be defined among patients treated with bisoprolol, another ?-blockers, angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin II receptor blockers, calcium channel blockers (CCB), or diuretics. Patients will be followed from the start of the prescription to discontinuation, addition of another antihypertensive treatment, patient death, transfer out date, December 2018.
The blood pressure reduction in hypertensive patients initiating a treatment with bisoprolol between 2000 and 2017 will be compared to the blood pressure reduction in patients initiating an antihypertensive treatment in the other cohorts. Indeed, the primary objective will be to investigate distinctly the average variation of systolic and diastolic blood pressure (BP). All the BP measurements within the follow-up period will be considered via joint models for longitudinal and time-to-event (death) data.
The secondary objectives will be to investigate the time to controlled BP, and the natural course of BP via a multistate Markov model. It will describe the course of hypertension within different states: controlled BP, and uncontrolled BP. In addition, the secondary objectives will be to investigate the first occurrence of adverse events (type 2 diabetes mellitus dyslipidaemia, erectile dysfunction, obesity, and hyperglycaemic events) via Cox proportional hazard models and Fine and Gray proportional subdistribution hazards models. Finally, the variation of body mass index between the drug initiation and one year after will be investigated via a linear regression.
To account for difference in baseline characteristics between group, 1 patient from the bisoprolol cohort will be matched on a propensity score to 4 patients in the compared cohorts. The propensity score will be built using boosted regression trees, with known risk factors for the outcomes.
Source -
Understanding the health care needs of people with common mental disorder and additional long-term conditions — Sarah Deeny ...
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Understanding the health care needs of people with common mental disorder and additional long-term conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-18
Organisations:
Sarah Deeny - Chief Investigator - The Health Foundation
Richard Welpton - Corresponding Applicant - The Health Foundation
Karen Hodgson - Collaborator - The Health Foundation
Mai Stafford - Collaborator - The Health Foundation
Will Parry - Collaborator - The Health FoundationOutcomes:
Our primary outcomes are
A) all-cause primary and secondary care utilisation
number and duration of primary care consultations;
number of prescribed products;
number of outpatient visits;
number of emergency department visits;
number and duration of hospital admissions.
B) All-cause patient outcomes
ambulatory care sensitive admissions;
30-day hospital readmissions;
all-cause mortality.Our secondary outcomes are mental health-related primary and secondary care utilisation
number of prescribed psychiatric products;
number of referrals to mental health services;
number of mental health-related outpatient visits;
number of mental health-related emergency dept visits;
number and duration of mental health-related hospital admissions.Description: Technical Summary
Objectives: In its long-term plan, the NHS committed to improving mental health services and growing investment in mental health services. Plans for mental health services should recognise that patients are presenting to the National Health Service with increasing levels of multimorbidity. Multiple conditions, along with socioeconomic deprivation, are associated with higher levels of some types of health care use. This study aims to support mental health service providers and commissioners to understand how health service needs for people with a common mental disorder (CMD) vary by level of deprivation and number of additional conditions.
This study will estimate: the prevalence of additional long-term conditions among adults with CMD, by age, sex, deprivation, and time. It will describe the use of primary and secondary health care and patient outcomes (mortality, readmissions, and ambulatory care sensitive admissions) for adults with CMD by number of additional conditions and socioeconomic deprivation.
Methods and data analysis:
This descriptive study is based on adults (18+ years) with CMD identified by diagnosis or treatment in primary care using CPRD. We will estimate the prevalence of 0, 1, and 2+ additional long-term conditions (based on a list of validated codes for 35 conditions) using repeat cross-sectional samples drawn each year from 2008/09 to 2017/18, by age, sex and Index of Multiple Deprivation (IMD) quintile.For the most up-to-date sample where follow-up data is available (2015/16), we will describe levels of primary and secondary care utilisation (as captured in HES) over a two-year follow-up period (2015/16 to 2017/18) according to the number of additional long-term conditions they have and their IMD quintile, with adjustment for age and sex.
We will estimate the age-sex-adjusted proportion who had a hospital admission for an ambulatory care sensitive condition, had a hospital readmission within 30 days, or died within the follow-up period and all-cause mortality by number of additional long-term conditions they have and their IMD quintile.
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Morbidity, mortality and quality of healthcare for people who use heroin and crack cocaine: a cohort study based on linked primary care data in England — Dan Lewer ...
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Morbidity, mortality and quality of healthcare for people who use heroin and crack cocaine: a cohort study based on linked primary care data in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-22
Organisations:
Dan Lewer - Chief Investigator - University College London ( UCL )
Dan Lewer - Corresponding Applicant - University College London ( UCL )
Amitava Banerjee - Collaborator - University College London ( UCL )
Andrew Hayward - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Caroline Shulman - Collaborator - University College London ( UCL )
Jennifer Quint - Collaborator - Imperial College London
Kenan Direk - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Naomi Van Hest - Collaborator - University College London ( UCL )
Neha Pathak - Collaborator - University College London ( UCL )
Paola Zaninotto - Collaborator - University College London ( UCL )
Robert Aldridge - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Thomas Brothers - Collaborator - University College London ( UCL )Outcomes:
Among all patients
1. Mortality
a. All-cause mortality
b. Cause-specific mortality (using ICD-10 chapters (such as Âcardiovascular diseasesÂ) and subgroups (which may be sections within chapters, such as Âischaemic heart diseaseÂ, or categories that cut across a number of chapters, such as Âbacterial and fungal infectionsÂ, which include diagnoses in chapter I, infections, and chapter L, skin).2. Healthcare utilisation
a. GP consultations (including practice nurse and health-care assistant)
b. A&E visits
c. Hospital admissions
d. Cause-specific hospital admissions and GP consultations (using ICD-10 chapters or existing disease phenotypes)
e. 30-day readmission rate among patients who are admitted
f. Outpatient visitsAmong patients with specific incident diseases
3. Chronic obstructive pulmonary disease
a. Disease stage (using the COPD GOLD disease stages 1-4 [1])
b. Secondary prevention interventions (see appendices)
c. Adverse outcomes (all-cause mortality, death due to respiratory disease or unplanned hospital admission due to respiratory disease)4. Cardiovascular disease
a. Whether blood pressure, BMI, and Q-risk values are recorded, and the recorded values.
b. Secondary prevention interventions (see appendices)
c. Adverse outcomes (all-cause mortality, death due to cardiovascular disease or unplanned hospital admission due to cardiovascular disease)5. Bacterial and fungal infections: longitudinal patterns of health-care visits and mortality before and after hospitalisation.
Description: Technical Summary
There are an estimated 314,000 people who use heroin and/or crack cocaine in England. Although the risk of infections, mental health problems and overdose in this group is well-characterised, there is limited research into healthcare needs related to common non-communicable diseases. Some studies in the UK have reported the rate of hospital admission in this group related to chronic diseases, but these data do not provide insight into the frequency of diseases that do not require hospitalisation, or into healthcare quality.
We will use routinely collected data from CPRD, linked to hospital and mortality data. We will define and describe a cohort of people who use heroin and/or crack cocaine based on Read codes and prescription codes in CPRD, as well as diagnostic codes in hospital data. Although access to primary care among members of this group may be poor, existing evidence suggests that around 90% of people in this group are registered with a GP, and preliminary counts suggest 67,000 individuals can be identified.
We will describe the rate of cause-specific primary and secondary care utilisation, using ICD-10 chapters and subgroups, in our study cohort and a matched group from the general population. We will also apply unit costs to compare the costs of healthcare in each group, using life table modelling to account for differences in mortality.
We will then identify incident cases of certain diseases (including chronic obstructive pulmonary disease) and measure the probability of receiving secondary prevention interventions (such as pulmonary rehab) and adverse outcomes (all-cause mortality, mortality due to the incident disease, and unplanned hospital admissions due to the incident disease). This analysis is guided by patient and public involvement, and existing analyses of causes of excess death in this population.
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Prevalence, management and prognosis of individuals with resolved asthma. — Harry Ahmed ...
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Prevalence, management and prognosis of individuals with resolved asthma.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-05
Organisations:
Harry Ahmed - Chief Investigator - Cardiff University
Harry Ahmed - Corresponding Applicant - Cardiff University
Bethan Cumins - Collaborator - Cardiff University
Hywel M. Jones - Collaborator - Cardiff University
Rebecca Cannings-John - Collaborator - Cardiff UniversityOutcomes:
1.     Prevalence of Âresolved asthmaÂ
2. Sociodemographic and clinical variables associated with a record of Âresolved asthmaÂ
3. Asthma-related hospital admissions [ICD-10 codes J45] and length of stay
4. Respiratory infection-related hospital admissions [ICD-10 codes J00-J06 (acute upper respiratory tract infections), J09-J18 (influenza and pneumonia), and J20-J22 (acute lower respiratory tract infections).
5. Asthma or respiratory infection-related death.Description: Technical Summary
Asthma is the most common respiratory condition in the UK. Long-term asthma management is part of the Quality and Outcomes Framework and GPs receive financial incentives to meet certain asthma quality performance indicators. Some patients asthma may improve and resolve over time, leading to a recorded diagnosis of Âresolved asthma which exempts them from asthma quality performance indicators and means they may no longer be routinely followed-up or reviewed in primary care. The Quality and Outcomes Framework suggests documenting Âresolved asthma in a patientÂs medical record if they have not needed to use any asthma medications for >12 months. Current clinical guidelines offer no advice on long-term care or follow-up of patients with resolved asthma. We hypothesise that these patients remain at greater risk of asthma and respiratory infection-related hospitalisation than population-based controls with no history of asthma. To test this hypothesis, we will do a cohort study, matching patients with resolved asthma to non-asthmatic controls on age, gender, and practice, and estimating incidence rate ratios (IRRs) for asthma and respiratory infection-related hospitalisation and deaths using Poisson regression models adjusted for measured confounders. We will also compare the incidence of these outcomes between patients with resolved asthma and active ongoing asthma. In addition, we will do descriptive analyses focussed on the prevalence and clinical management of resolved asthma in UK primary care. These analyses will help us to understand how best to organise and deliver long-term care to this group of patients.
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Antibiotic use and risk of glioma — Susan Jick ...
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Antibiotic use and risk of glioma
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-09-24
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
- Corresponding Applicant -
Christoph Meier - Collaborator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Michael Leitzmann - Collaborator - University of Regensburg
Peter Hau - Collaborator - University of Regensburg
Ralf Linker - Collaborator - University of Regensburg
Tareq Anssar - Collaborator - University of RegensburgOutcomes:
Any antibiotic use and risk of glioma; use of specific antibiotics and risk of glioma;
Record of at least one Read code for glioma will be sufficient to confirm the diagnosis (see appendix A).Description: Technical Summary
Effectors from the immune system like macrophages or T cells can modulate the course of gliomas. Antibiotic drugs are frequently used drugs that could influence gliomas through various mechanisms. To date, there is very limited data available concerning the risk of glioma after exposure to antibiotic drugs and the results for other tumour entities remain inconclusive. Therefore, we intend to perform a matched case-control study based on data from the CPRD to investigate the risk of glioma in relation to use of antibiotic drugs. Cases will be patients with a first diagnosis of glioma between 1995 and 2018. The index date will be the date of the glioma diagnosis minus one year. Controls will be matched 10:1 to cases on index date, age, sex, general practice and number of years of medical history in the database prior to the index date. The exposure of interest will be defined as use of any antibiotic drug, and then use by selected classes of antibiotic drugs, one or more years before the index date. We will also investigate the number of prescriptions of the antibiotic drugs. We will perform conditional logistic regression analyses to estimate crude and adjusted odds ratios (ORs) with 95% confidence intervals (CIs). We will adjust the analyses for potential confounders and include factors altering the risk of glioma by >10% in the final multivariate analysis.
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North West London Health Research Register North West London Hypertension Cohort – Consent to Contact — Royal Brompton Hospital...
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North West London Health Research Register North West London Hypertension Cohort – Consent to Contact
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-19
Opt Outs: no information provided./p>
Organisations: Royal Brompton Hospital
Description: Hypertension. Commercial
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Prognostic features for renal and/ or vascular complications in people with type 2 diabetes mellitus — Imperial College Healthcare NHS Trust...
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Prognostic features for renal and/ or vascular complications in people with type 2 diabetes mellitus
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-19
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Type 2 Diabetes. Academic
Source -
Retrospective Study into the Journey of Patients with Type 2 Diabetes in the Integrated Health and Social Care System in North West London — Imperial College Healthcare NHS Trust...
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Retrospective Study into the Journey of Patients with Type 2 Diabetes in the Integrated Health and Social Care System in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-19
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Type 2 Diabetes. Academic
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Determination of the burden of illness for patients with Hypogonadism in North West London — Imperial College Healthcare NHS Trust...
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Determination of the burden of illness for patients with Hypogonadism in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-19
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Hypogonadism. Commercial
Source
2019 - 08
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Outcomes for looked-after children in Northern Ireland — unknown...
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Outcomes for looked-after children in Northern Ireland
Where: unstated
When: 2019-8-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: The aim of this project is to build a powerful retrospective cohort exploring the social trajectories of children leaving care to examine factors associated with both poor and positive outcomes. Specifically, the project will address three main research questions investigating:
Changes in the profile of children known to social services over the last 30 years The long-term outcomes of being a child known to social services including mental and physical health outcomes; suicide risk; self-harm; educational attainment; employment status; and variation within reason for contact with social services and social services intervention The effect of critical periods and transitions.
Source -
— unknown...
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Where: unstated
When: 2019-8-14
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to investigate the long-term outcomes of children in contact with social services, with a focus on identifying factors that contribute to both positive and negative outcomes.
Existing research indicates that children known to social services have high levels of mental health needs, while children leaving care have poorer health, educational and employment outcomes. However, research focusing on the predictors of positive outcomes within this cohort is rare.
Source -
Outcomes for looked-after children in Northern Ireland — Dr Aideen Maguire...
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Outcomes for looked-after children in Northern Ireland
Where: unstated
When: 2019-8-14
Opt Outs: no information provided./p>
Who: Dr Aideen Maguire, Queenâs University Belfast (ADR Northern Ireland).
Datasets:see text
Why: Specifically, the project will address three main research questions investigating:â¯â¯
Changes in the profile of children known to social services over the last 30 yearsâ¯
Theâ¯long-termâ¯outcomes of being a child known to social services including mental and physical health outcomes; suicide risk;â¯self-harm;â¯educational attainment; employment status; and variation withinâ¯reason for contact with social services and social services interventionâ¯
The effect of critical periods and transitions.
This project will investigate the relationship between childhood interactions with social services and risk of poor health and social outcomes in adulthood. It will useâ¯30â¯yearsâ worthâ¯ofâ¯Northern Ireland social services dataâ¯from theâ¯Social Services Care Administrative and Records Environmentâ¯(SOSCARE,â¯1985-2015) linked to Census returns,â¯prescribedâ¯medication data, hospital data, the registry of self-harmâ¯and death recordsâ¯at an individual level.
This is the UK's first historical, population-wide cohortâ¯of individuals known to social services as children,â¯identifying those who wereâ¯a Child in Need, on the Child Protection Register and/or a Looked After Child.â¯From this linked dataset the research team will be able to follow individuals over aâ¯30-yearâ¯period to examineâ¯a range of outcomes including: receipt of psychotropic medication;â¯psychiatric hospital admission; self-harm;â¯employment status; educational attainment; and death by suicide.
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Comparative Long-Term Effectiveness of Treatments for Patients with Drug-Resistant Epilepsy: a descriptive study — Carly Rich ...
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Comparative Long-Term Effectiveness of Treatments for Patients with Drug-Resistant Epilepsy: a descriptive study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-21
Organisations:
Carly Rich - Chief Investigator - Harvey Walsh Ltd
Mark Evans - Corresponding Applicant - OPEN Health Group
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
David Heaton - Collaborator - Harvey Walsh Ltd
Matthew O'Connell - Collaborator - Harvey Walsh LtdOutcomes:
Primary outcomes
All inpatient admissions, epilepsy related admission; accident and emergency contacts.Secondary outcomes
Duration of inpatient stay; all outpatient contacts; neurology all outpatient contacts; psychiatric all outpatient contacts; all outpatient contacts in all other specialities; anti-epilepsy drug prescriptions; epilepsy rescue prescriptions; other prescriptions related to the central nervous system; all other prescriptions; all-cause mortalityDescription: Technical Summary
This is a retrospective, non-interventional study (NIS) based on a secondary use of anonymised, patient level data obtained from primary (CPRD GOLD) and secondary care (HES) databases. The objective of this study is to measure the real-world effectiveness of different treatments, as proxied by healthcare utilisation. Patients with a diagnosis of epilepsy who are defined as intractable based on a minimum 2-day inpatient admission for epilepsy monitoring will be classified by the following treatments modalities: (i) continued anti-epilepsy drug (AED) therapy with no additional treatment; (ii) epilepsy surgery, generally with continued AED therapy; (iii) Vagus Nerve Stimulation therapy adjunctive to AED therapy. The primary analyses will evaluate total inpatient hospitalizations, epilepsy-related inpatient hospitalizations and accident & emergency (A&E) department visits. Duration of inpatient stay, total outpatient services utilisation, drug utilisation and all-cause mortality will be evaluated in secondary analyses. Patient demographics and baseline characteristics will be summarized by treatment group and overall. Outcome incidence rates will be calculated on patient-quarters by treatment group and overall. Mean changes from baseline in incidence rates over time, together with the associated 95% CI, will be derived overtime. Evaluation of the effectiveness of population-level health interventions will be performed by means of the Interrupted Time Series analysis.
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Occurrence and consequences of Langerhans cell histiocytosis, Malignant Histiocytosis, Erdheim-Chester Disease and Haemophagocytic Lymphohistiocytosis: a population based cohort study — Joe West ...
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Occurrence and consequences of Langerhans cell histiocytosis, Malignant Histiocytosis, Erdheim-Chester Disease and Haemophagocytic Lymphohistiocytosis: a population based cohort study
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-04
Organisations:
Joe West - Chief Investigator - University of Nottingham
Joe West - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Johann Visser - Collaborator - Cambridge University Hospitals
Judith Rankin - Collaborator - Newcastle University
Lu Ban - Collaborator - University of Nottingham
Lucy Ellis-Brookes - Collaborator - National Cancer Intelligence Network - NCIN
Mark Bishton - Collaborator - Nottingham University Hospitals
Mary Bythell - Collaborator - Public Health England
Peter Lanyon - Collaborator - Nottingham University Hospitals
Timothy Card - Collaborator - University of Nottingham
Vasanta Nanduri - Collaborator - West Hertfordshire Hospitals NHS TrustOutcomes:
Incidence, point prevalence, all cause and cause specific mortality
Description: Technical Summary
There are few population-based studies examining the epidemiology of histiocytic diseases, due to the difficulty in identifying large enough numbers of cases. Routinely collected electronic health data from the UK National Health Service provides a potential opportunity to research these diseases. The objectives of this study therefore are to assess the occurrence of Langerhans cell histiocytosis (LCH), Malignant Histiocytosis (MH), Erdheim-Chester disease (ECD) and Haemophagocytic Lymphohistiocytosis/Haemophagocytic syndrome (HLH) as recorded in electronic health records in England between 2000 and 2018, and to measure the incidence, point prevalence and long-term outcomes.
We will determine LCH, MH, ECD and HLH from CPRD primary care, HES inpatients and Cancer Registry datasets. We will assess the extent of ascertainment of identified cases between the three datasets. Having assessed our case ascertainment, we will carry out incidence and mortality analyses for LCH, MH, ECD and HLH. We will analyse and describe trends over time and the known alterations in coding structures and algorithms of the recording of histiocytosis. We will examine the rates of new diagnoses (incidence) and point prevalence of LCH, MH, ECD and HLH by age, sex, socioeconomic status and region using Poison regression. We will also calculate the 30-day, 1 and 5-year survival. Cox regression will be used to calculate the hazard ratios and a Fine & Gray regression model will be used to estimate cause-specific mortality adjusting for the competing risk of death from other causes.
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GLP-1 receptor agonists and the risk of anaphylactic reactions among patients with type 2 diabetes — Samy Suissa ...
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GLP-1 receptor agonists and the risk of anaphylactic reactions among patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-29
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Christina Santella - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Anaphylactic reactions (Read codes and SNOMED-CT concept IDs outlined in Appendix 1).
Description: Technical Summary
There is conflicting evidence in the literature regarding the association of GLP-1 receptor agonists and the risk of anaphylactic reactions. Indeed, GLP-1 receptor agonists are potentially immunogenic as they are protein-based molecules. Importantly, two of the approved GLP-1 receptor agonists, exenatide and lixisenatide, are structurally similar to exendin-4, an animal derived protein (hereafter called animal-based GLP-1 receptor agonists), while four other approved drugs of this class, liraglutide, dulaglutide, albiglutide, and semaglutide, are structurally similar to the human GLP-1 molecule (hereafter called human-based GLP-1 receptor agonists). To date, while several case reports of GLP-1 receptor agonist-associated anaphylactic reactions have been published in the literature, no observational study has been conducted to determine the association between GLP-1 receptor agonist use and anaphylactic reactions. Thus, this study will use the Clinical Practice Research Datalink to assemble a cohort of patients, at least 40 years of age, newly-treated with antidiabetic drugs between January 1, 2007 and January 31, 2019. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of anaphylactic reactions associated with animal-based or human-based GLP-1 receptor agonists compared with second- to third-line antidiabetic drugs. Secondary analyses will assess whether there is a duration-response relationship, and whether the risk varies by history of previous allergic conditions.
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Understanding the use of long-term antibiotics for acne in the United Kingdom — Sinead Langan ...
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Understanding the use of long-term antibiotics for acne in the United Kingdom
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-11
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ketaki Bhate - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Clémence Leyrat - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laura Shallcross - Collaborator - University College London ( UCL )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nicholas Francis - Collaborator - Cardiff University
Richard Stabler - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah-Jo Sinnott - Collaborator - Not from an Organisation
Susan Hopkins - Collaborator - Public Health EnglandOutcomes:
This is a drug utilisation study aiming to identify how topical and oral antibiotics for acne are prescribed over the course of this chronic disease.
Outcomes will therefore be defined as:
1) Initiation of an oral or topical antibiotic for acne.
2) Substituting/switching a topical or oral antibiotic for another between classes.
3) Addition of an antibiotic to existing antibiotic treatment
4) Discontinuation of a topical or oral antibiotic.
5) Duration of antibiotic treatment including median duration.
6) Re-initiation of an antibiotic  this is defined as a further prescription of an antibiotic after having previously been prescribed an antibiotic for a minimum of 4 weeks for acne, regardless of class, if there is no antibiotic prescription covering the previous 60 days.Definitions to be used:
Treatment initiation (figure 1):
A new topical or oral antibiotic prescribed for at least 28 days preceded by 365 days of no antibiotic use. As there are no Daily Defined Doses (DDDs) for topicals, 0.5g per day will be amount used to define a daily dose as has been used by other studies.(1, 2) For the purposes of analysis, people with an antibiotic prescription for acne for less than 28 days will be excluded.Treatment switching (figure 2):
Treatment switching is defined as the addition of a second antibiotic class (for acne) without the continuous use of the initial first antibiotic. The new antibiotic is used in place of the previous antibiotic treatment. Therefore, if a second drug is added, but with less than 30 overlapping days supply, this will be defined as a treatment switch between antibiotics. Second, third and fourth antibiotic initiation will only be considered treatment switches if there are 30 or less days supply from the prescription of the previous antibiotic.Treatment addition (figure 3):
If there are overlapping days supply for the first and second antibiotic for 30 days or more then this is defined as a treatment addition of the second antibiotic, (and for subsequent antibiotic additions thereafter defined as the third and fourth additions etc).Treatment discontinuation (figure 4):
This is defined as no available days of antibiotic supply 30 days after the last covered day.Treatment re-initiation (figure 5):
This is defined as an antibiotic prescription in those who have previously received antibiotics for their acne with a treatment gap of at least 30 days.We will stratify drug utilisation across age categories, geographic location (if possible), calendar year, quintiles of Index of Multiple Deprivation (IMD), Ethnicity and sex to understand prescribing in separate populations.
Description: Technical Summary
The World Health Organisation declared the threat of Antimicrobial Resistance (AMR) a most urgent crisis. Without intervention, it is expected up to 10 million deaths/year from infections will occur by 2050 and the cost could reach 100 trillion USD. The overuse of antibiotics is a known driver of AMR as repeated and sustained exposure allows microbes to develop mechanisms to avoid the effects of drugs designed to defeat them.
Acne vulgaris is a chronic skin disorder with onset predominantly in adolescence. Prevalence studies show that 80-100% of adolescents have acne and 20% are moderately-severely affected. Duration is variable with 5% of people in their 50s with acne. Topical/oral antibiotics are commonly prescribed for the treatment of acne for several months. Tetracyclines and macrolides are the two most common oral antibiotic classes prescribed with dihydrofolate-reductase inhibitors (trimethoprim) prescribed second-line.
The pathophysiology of acne is multifactorial and although Cutibacterium acnes is associated in the development of acne, acne is not an infection, and antibiotics are used predominantly for their anti-inflammatory effects over antimicrobial. We do not understand how long-term antibiotics for acne attenuate flora elsewhere, nor how they influence the ability of bacteria at other infective sites to withstand their effects, which may contribute to AMR. Antibiotic prescribing is not generalisable across countries, as practices vary, therefore studies investigating antibiotic use elsewhere may not be applicable to the UK. While a previous study aimed to establish how acne medications are prescribed in the UK, follow up was restricted to one year. Given the chronicity of acne and the common practice of using antibiotics intermittently over several years, further study over a longer period is warranted. The overall aim of this study is to use the CPRD to elucidate how people with acne are managed with long-term oral/topical antibiotics in primary care for up to five-years follow-up.
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Eating Disorders in Mothers and subsequent pregnancy outcomes — Joan Morris ...
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Eating Disorders in Mothers and subsequent pregnancy outcomes
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-14
Organisations:
Joan Morris - Chief Investigator - St George's, University of London
Joan Morris - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
Primary Outcomes : Adverse pregnancy outcomes including low birth weight, high birth weight, small for gestational age, miscarriages, births by caesarean section, any delivery complications and any diagnoses of a congenital anomaly, with an emphasis on major congenital anomalies as defined by EUROCAT Guide 1.4 (www.eurcat-network.eu/aboutus/datacollection/guidelinesforregistration/â¦). For twin pairs all twins with the the lowest birthweight will be compared and separately all twins with the highest birthweight will be compared.
Description: Technical Summary
The aim of this study is to quantify reported associations between eating disorders (ED) in pregnancy and adverse pregnancy outcomes (such as miscarriages, caesarean sections and low or high birth weights / gestational age) in this UK cohort and determine if there is an association with a history of eating disorders prior to pregnancy.
It is not expected that there will be sufficient power to detect a statistically significant increased risk of a congenital anomaly in mothers with an eating disorder, but a descriptive analysis on such a large sample of women will be informative and could prompt further research into specific congenital anomalies with a case control design.
Using pregnancies identified in the CPRD pregnancy register, the prevalence of adverse pregnancy outcomes will be compared amongst mothers with a history of an ED, mothers with an ED during pregnancy and mothers with no history of an ED matched for multiplicity, year of birth, maternal age at pregnancy and GP. Controls are selected by pregnancy and therefore a mother without an eating disorder having two pregnancies may be selected to be a control to two different pregnancies in two mothers with an eating disorder. Similarly, a mother with an eating disorder in her first pregnancy may not have a current eating disorder in her second pregnancy, only Âa history of an eating disorderÂ. Therefore, in the main analysis the occurrence of siblings will be ignored. A sensitivity analysis will be performed including only each womenÂs first pregnancy occurring in the cohort.Potential confounders, such as maternal smoking and alcohol consumption will be adjusted for using propensity score matching (for example women who smoke may be more likely to have eating disorders). Multiple births, maternal age and deprivation will be adjusted for through the matching.
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Real-world observational study to evaluate probability of achieving glycemic control after initiation of glucagon-like peptide-1 receptor agonists or basal insulin in T2DM patients (UK CPRD database) — Robert Lubwama ...
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Real-world observational study to evaluate probability of achieving glycemic control after initiation of glucagon-like peptide-1 receptor agonists or basal insulin in T2DM patients (UK CPRD database)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-27
Organisations:
Robert Lubwama - Chief Investigator - Sanofi US Services Inc
Victor Peng - Corresponding Applicant - SANOFI
- Collaborator -Outcomes:
Primary Outcome:Glycemic control outcomes post GLP-1RA or BI initiation:
a. HbA1c change over time in 720 days post GLP-1RA or BI initiation (via descriptive statistics). The 720-day post GLP-1RA or BI initiation period will be divided into consecutive 180-day periods. The mean change in HbA1c from baseline to each 180-day period will be calculated. For each time-period, patients with both baseline and a follow-up HbA1c will be included. Window periods may be adjusted to ensure adequate numbers. Multiple HbA1c measures will be included, and robust standard errors will be presented.
b. Cumulative probability of reaching HbA1c <7.0% over time in 720 days post GLP-1RA or BI initiation (via Kaplan Meier estimation); Conditional probability of reaching glycemic control every quarter post GLP1RA or BI initiation: This is defined as the probability of reaching glycemic control during a quarterly interval if the patient had NOT already reached control prior to that interval.
c. Association of baseline characteristics to glycemic control outcome post GLP-1RA or BI initiation (via Cox regression model)Description: Technical Summary
Background and aims: Type 2 Diabetes mellitus (T2DM) is a chronic progressive disease despite multiple treatment options. Large interventional studies have highlighted the benefits of achieving glycemic targets to reduce risks of complications for patients with T2DM. The efficacy of injectable glucagon-like peptide-1 receptor agonists (GLP1RA) or basal insulin (BI) for the treatment (Tx) of type 2 diabetes mellitus (T2D) patients (pts) has been well established in randomised controlled clinical trials. However, there is increasing interest and need to also evaluate their clinical effectiveness in real-world (RW) practice. This study will investigate the RW effectiveness of GLP1RA and BI to achieve glycaemic control in T2D pts in the UK Clinical Practice Research Datalink (CPRD) database.
Materials and methods: T2D pts aged ?18 years (y), with HbA1c ?7.0% on oral antihyperglycaemic drugs (OADs), who initiated Tx with a GLP1RA or BI between 01/01/2010 and 30/06/2016 were identified from the UK CPRD database. The index date will be defined as first Tx date with a GLP1RA or BI (independently). Glycaemic control outcomes over a 2-y follow-up period including HbA1c change over time and cumulative probability of reaching first HbA1c <7.0% will be described. Descriptive statistics will be calculated to describe the baseline demographics and clinical characteristics of the study cohort and subcohorts. Means and standard deviations (SD) will be reported for continuous variables and percentages are provided for categorical variables.
Each quarter post-index date will defined to be 90 days, i.e., 0Â90 days as the first quarter (0Â3 months); 91Â180 days as the second quarter (3Â6 months), etc. The descriptive statistics of HbA1c change from baseline will be calculated semi-annually following GLPRLA/BI initiation.The associations between baseline (BL) characteristics and glycaemic control outcomes will also be analysed by a Cox model.
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A real-world study comparing the effectiveness and safety of glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter 2 inhibitors (SGLT-2is) in patients with type 2 diabetes — Laura Gray ...
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A real-world study comparing the effectiveness and safety of glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter 2 inhibitors (SGLT-2is) in patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-27
Organisations:
Laura Gray - Chief Investigator - University of Leicester
Humaira Hussein - Corresponding Applicant - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
Effectiveness outcomes:
Primary (Cardiovascular) outcomes - hospitalisation for heart failure, all-cause mortality, 3-point MACE (major adverse cardiovascular events): stroke, myocardial infarction and cardiovascular mortality.Secondary (Cardiometabolic) outcomes - change in: glycated haemoglobin (HbA1c; %, mmol/mol), body weight (kg), total-cholesterol (mmol/l), HDL-cholesterol (mmol/l), LDL-cholesterol (mmol/l), triglycerides (mmol/l), systolic blood pressure (mm/Hg), diastolic blood pressure (mm/Hg) and heart rate (bpm).
Safety outcomes - hypoglycaemia, amputations, bone fractures, pancreatitis, cancer, genital infection, urinary tract infection, injection site reactions, abdominal pain and diabetic ketoacidosis.
Description: Technical Summary
New drugs for the management of hyperglycaemia in type 2 diabetes are continuously being developed. In recent years, advancements have been made in two classes of glucose-lowering drugs: glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter 2 inhibitors (SGLT-2is).
As well as reducing blood sugar levels, evidence shows that these classes of drugs also improve cardiovascular and renal outcomes. However, much of this evidence is based on randomised controlled trials and does not fully represent patients in the real-world clinical setting. Although guidelines suggest when GLP-1RAs and SGLT-2is should be administered, current research lacks clear guidance as to which specific drug should be used first. Available systematic reviews and network meta-analysis have compared effectiveness of these drugs within these two classes, however, the benefitÂrisk profile between the two classes and which drug should be preferred remains unclear.
This study will use routinely collected data from the Clinical Practice Research Datalink to initially describe demographic and medical profiles of patients taking GLP-1RAs or SGLT-2is. This will be followed by a risk-assessment of heart failure hospitalisation, cardiovascular events and mortality between the two drug classes. Intermediate cardiometabolic outcomes (i.e. glucose lowering, body weight, blood pressure and cholesterol levels) and adverse events will also be assessed.
Source - and 10 more projects — click to show
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Eating Disorders in Mothers and subsequent long term health effects in their children — Joan Morris ...
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Eating Disorders in Mothers and subsequent long term health effects in their children
Datasets:GP data, CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-27
Organisations:
Joan Morris - Chief Investigator - St George's, University of London
Joan Morris - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
Primary Outcomes : Any diagnosis of ADHD, ASD, dyspraxia or learning disabilities and any prescriptions for
drugs prescribed for ADHD (atomexetine, methylphenidate, dexamphetamine, lisdexamphetamine or modafinil).
Any diagnoses of a congenital anomaly, with an emphasis on major congenital anomalies as defined by EUROCAT Guide 1.4 (www.eurcat-network.eu/aboutus/datacollection/guidelinesforregistration/â¦)Description: Technical Summary
Studies have shown that sodium valproate taken during the first trimester of pregnancy is not only teratogenic, but also has important longer-term effects on the childrenÂs neurodevelopment. It is likely that other first trimester exposures may also have these longer-term effects. However, such studies are difficult to perform, because of the necessity of a long follow-up in large mother-baby cohorts. One small study in 2004 identified both an increased risk of microcephaly (head size smaller than 2 sd of the norm) at birth and neurodevelopmental deficits at 5 years of age in children born to mothers with an eating disorder compared with mothers with no eating disorder.
The primary aim of this study is to determine if the mother experiencing an eating disorder (ED) before or during pregnancy may have an adverse effect on the childÂs neurodevelopment by age 11 (indicated by any read codes corresponding to ADHD, ASD, learning disabilities or dyspraxia or prescriptions for medicines for ADHD).
The prevalence of these neurodevelopmental measures in the children will be compared amongst mothers with a history of an ED, mothers with an ED during pregnancy and mothers with no history of an ED matched for year of birth, maternal age at pregnancy and GP. Cox proportional hazards regression will be used to analyse time till first diagnosis. Potential confounders, such as maternal smoking and alcohol consumption will be adjusted for using propensity score matching. The influence of siblings or multiple births will be dealt with by performing a sensitivity analysis including only the first birth or one of the multiples.
A secondary aim of this study is to determine if the CPRD will be a useful resource for examining the long term effects in children of different exposures in utero.
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Statins and the risk of Venous Thromboembolism — Susan Jick ...
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Statins and the risk of Venous Thromboembolism
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-11
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Lade Ayodele - Collaborator - Decision Resources GroupOutcomes:
The outcome will be incident idiopathic VTE (DVT and PE. Using Read codes, we will identify the first record of an incident VTE diagnosis in the medical record after study entry (the date of first statin or fibrate prescription).
Idiopathic VTE cases will be defined as any VTE case that does not have a code for a proximate cause of VTE (such as surgery, trauma, see below) recorded in the CPRD within 90 days prior to the VTE diagnosis date. We will employ this criterion because, if there is an effect of statin use on VTE, including non-idiopathic VTE cases could dilute the true effect of the statin, (because it is unlikely that there is an effect of the drug in non-idiopathic cases where the VTE is triggered by another cause) and exposure is likely to reflect the exposure in the base population. Proximate causes of VTE include pregnancy, immobility, prolonged hospitalization, fractures, multiple trauma, orthopaedic surgery involving long bones or pelvis and, other major surgery. Any participant with a VTE that occurs after a proximate cause will be retained in the study sample, however they will not be considered a case in this study since they do not meet the case definition of idiopathic VTE.
To validate the VTE diagnosis we will require that all cases receive a prescription for an anticoagulant (including unfractionated heparin, low-molecular-weight heparins (LMWH) and fondaparinux) present after the VTE diagnosis.
VTE codes and anticoagulants are provided in Appendix 1 and Appendix 2, respectively. We will also consider adding other new anticoagulants and antiplatelet drugs.VTE codes are provided in Appendix 1.
Description: Technical Summary
Venous thromboembolism (VTE) poses an important disease burden, however a lot remains unknown about risk factors associated with it. Over 25% of Americans >40 years old take statins to treat hypercholesterolemia, particularly patients with other cardiovascular risk factors, and the lipid-lowering effect of statins has been shown to significantly reduce the risk of arterial embolic events12-14. In contrast, randomized and non-randomized studies evaluating the relationship between statin therapy and VTE outcomes have found conflicting results11;15-41. Thus, additional studies are needed to investigate this potential association.
This will be a cohort study among adults during 1995-2017 in the UK-based CPRD. To be included, patients must have; 1)at least one diagnosis of dyslipidaemia, 2)at least one statin or fibrate prescription, 3)at least one year of history in the CPRD before the statin or fibrate prescription, 4)no prior diagnoses of CKD, vasculitis or coagulopathy and 5)no diagnoses of cancer (except non-melanoma skin cancer). Exposed patients will be patients with >=3 statin prescriptions and will be matched by propensity scores to patients with only fibrate prescriptions or <3 statin prescriptions in their record. We will follow both cohorts until the development of VTE, death, end of CPRD record, or end of the study period, whichever comes first. Based on the feasibility analyses, we will not be able to compare statin-only to fibrate-only users due to the relatively low number of fibrate-only users when compared to statin-only users.
Using descriptive analyses and Cox proportional hazard models, we will evaluate the relationship between the risk of VTE and statin exposure, in relation to timing, duration of use, number, and dose of statin prescriptions. The proposed study will efficiently evaluate the safety/benefits of statins, which will guide the development of guidelines for its use in the care of patients with hypercholesterolemia and cardiovascular disease risk.
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A multi-database retrospective study of the comparative efficacy and safety of SGLT2 inhibitors in the management of type 2 diabetes (EMPRISE-UK) — Kamlesh Khunti ...
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A multi-database retrospective study of the comparative efficacy and safety of SGLT2 inhibitors in the management of type 2 diabetes (EMPRISE-UK)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-19
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Muna Adan - Corresponding Applicant - Leicester Diabetes Centre
Francesco Zaccardi - Collaborator - University of Leicester
Freya Tyrer - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - Leicester Diabetes CentreOutcomes:
Effectiveness outcomes
Primary outcomes:
Hospitalisation for heart failure (HHF)
All-cause mortality
Cardiovascular mortality
MACE outcomes (myocardial infarction, stroke and cardiovascular mortality)
Secondary outcomes:
End-stage renal disease
Percutaneous coronary interventionSafety outcomes
Bone fracture
Diabetic ketoacidosis
Severe hypoglycaemia
Urinary tract cancers: bladder cancers, renal cancers, other urinary tract cancer (Appendix
Urinary tract infections or genitourinary infections
Lower limb amputation
Acute kidney injury requiring dialysisHealthcare utilisation
Secondary care: time to hospitalisation, number of in-patient admissions per person-year and length of hospital stay
Primary care: number of GP consultations (in-practice, home-visits, telephone) per person-yearDescription: Technical Summary
UK guidance recommends that sodium-glucose co-transporter 2 (SGLT2) inhibitors be considered as an option alongside other glucose-lowering agents at the first intensification of treatment for type 2 diabetes, where the patient has failed to achieve glucose control or cannot tolerate metformin. Growing evidence suggests that SGLT2 inhibitors have a favourable cardiometabolic safety profile but much of this evidence is based on randomised controlled trials which limits generalizability to the real-world clinical setting.
This part of a 5-site collaboration of different databases in the UK (SAIL, Discover, THIN, CPRD, RCGP). For the proposed analysis, Data from the Clinical Practice Research Datalink (CPRD) Gold database with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) will be used to investigate:
1. risk of hospitalisation for heart failure in people with type 2 diabetes prescribed SGLT2 inhibitors compared with DPP-4 inhibitors;
2. risk of all-cause mortality in people with type 2 diabetes prescribed SGLT2 inhibitors compared with DPP-4 inhibitors;
3. risk of a composite outcome of all-cause mortality and hospitalisation for heart failure in people with type 2 diabetes prescribed SGLT2 inhibitors compared with DPP-4 inhibitors;
4. risk of cardiovascular mortality;
5. risk of composite outcomes of hospitalisation for heart failure and cardiovascular mortality;
6. risk of 3-point major adverse cardiovascular events (MACE), defined as a composite outcome including myocardial infarction, stroke and cardiovascular mortality in people with type 2 diabetes prescribed SGLT2 inhibitors compared with DPP-4 inhibitors;
7. risk of percutaneous coronary intervention;
8. risk of end-stage renal disease in people with type 2 diabetes prescribed SGLT2 inhibitors compared with DPP-4 inhibitors.
9. risk of hospitalisation, all-cause mortality, composite outcomes for empagliflozin vs DPP-4 inhibitors.Results from the 5-sites will be combined using meta-analysis. We will take account of any overlap between CPRD and THIN using established methods.
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Childhood poisoning substance trends in England, 1998-2018 — Edward Tyrrell ...
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Childhood poisoning substance trends in England, 1998-2018
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-27
Organisations:
Edward Tyrrell - Chief Investigator - University of Nottingham
Edward Tyrrell - Corresponding Applicant - University of Nottingham
Denise Kendrick - Collaborator - University of Nottingham
Elizabeth Orton - Collaborator - University of Nottingham
Laila Tata - Collaborator - University of NottinghamOutcomes:
The outcome will be incident poisoning events during the study period, recorded in any one of: primary care data, HES admission data or ONS mortality data by the use of at least one relevant Read code or ICD-10 code (see provisional code list in appendix A). Such codes will be identified from either the Medcode variable within the Clinical file (CPRD data) or from HES admission (ICD variable within Diagnosis codes) or ONS cause of death codes. See section N for more details.
Other key variables will include: sex, age, socio-economic deprivation (using Index of Multiple Deprivation 2010 quintiles), geographical area (Region variable within the Practice file), year of event and relevant prescribed medication to any household member (this will require use of the Family Number variable in the Patient file, as well as prescription data within the Therapy file). Prescription data will only be extracted following completion of the cohort study. These data will then be used to define exposures in the nested case-control elements.Description: Technical Summary
Background: Poisonings among 0-11 year olds are an important cause of ill health but are potentially preventable. Up-to-date evidence of the exact substances involved, socioeconomic gradients and time trends, including any effect of the austerity agenda, are lacking. No studies have examined the relationship between substances involved in childhood poisonings and medications prescribed to household members. Updated population level data are therefore required to guide commissioning decisions, safe prescribing and safety advice offered to families.
Aims: 1.To estimate population level medically-attended poisoning incidence among 0-11 year olds in England from 1998-2018 by poisoning substance, sex, age, deprivation level, geographical area and changes over time. 2.To examine the relationship between medicinal poisonings in these children and medicines prescribed to household members by primary care.
Design and Setting: An open cohort study of all 0-11 year olds in the Clinical Practice Research Datalink (CPRD) with available linked Hospital Episode Statistics (HES) and Office for National Statistics (ONS) mortality data, plus nested case-control study.
Method: The cohort study will establish poisoning episodes by substance using ICD-10 (HES/ONS data) and/or Read (CPRD data) codes. Incidence rates and adjusted incidence rate ratios will be calculated using Poisson or negative binomial regression for poisonings in relation to substance, age, sex, deprivation, year and geographical area. A series of nested case-control studies will be constructed using cases (poisonings involving the 5 most common medicinal substances identified in the cohort study) and controls (no poisoning with the specified substance). Conditional logistic regression will be used to examine odds ratios for poisonings involving these substances and that specific medicine being prescribed to a household member.
Impact: Results will be used to inform prescribing practices and safety advice offered to families within primary care. They will also assist healthcare commissioners and individual practitioners make decisions about poisoning prevention interventions.
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Association of Polycystic Ovary Syndrome with patient and offspring cardiometabolic outcomes: a retrospective, observational study — Aled Rees ...
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Association of Polycystic Ovary Syndrome with patient and offspring cardiometabolic outcomes: a retrospective, observational study
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-04
Organisations:
Aled Rees - Chief Investigator - Cardiff University
- Corresponding Applicant -
- Collaborator -
Aled Rees - Collaborator - Cardiff University
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Myocardial infarction, angina, stroke, revascularisation in women with PCOS; increased birth weight and obesity in off-spring, premature adrenarche in off-spring.
Description: Technical Summary
The aim of the study is to determine if there is an increased risk of cardiovascular events and mortality in patients with Polycystic Ovary Syndrome (PCOS). Both Aurum and GOLD will be used. Aurum will provide sufficient statistical power to ascertain the primary outcome, whilst the smaller population in GOLD will be required to utilise the mother-baby link. The study population will comprise patients with a diagnosis of PCOS from the Clinical Practice Research Datalink (CPRD) based on either a primary care diagnosis using the Read code classification or an ICD-10 coding from secondary care Hospital Episodes Statistics. These patients will then be matched by age, body mass index and primary care practice to control subjects with no history of PCOS. Subjects will be linked to offspring using the CPRD family number. Primary outcomes will be the incidence of large vessel disease (defined by the first record of myocardial infarction, angina, stroke, or revascularisation) identified from either Read code in the CPRD Aurum dataset or ICD-10 code in the HES inpatient dataset. Secondary outcomes will be the incidence of overweight/obesity and premature adrenarche in the children of mothers with PCOS identified from CPRD GOLD. Rates of progression to each primary outcome will be presented and compared using Cox proportional hazard models (CPHM) adjusting for smoking status, Charlson Index, total number of contacts with the general practitioner in the year prior to the index date, and IMD quintile.
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Estimating primary and secondary healthcare resource costs for people with type 1 and type 2 diabetes in the United Kingdom — ...
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Estimating primary and secondary healthcare resource costs for people with type 1 and type 2 diabetes in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-19
Organisations:
- Chief Investigator -
- Corresponding Applicant -
- Collaborator -
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Craig Currie - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Healthcare resource use and associated healthcare costs.
Description: Technical Summary
The aim of this study is to characterise the primary and secondary healthcare costs of treating people with diabetes.
Patients in CPRD whose data are eligible for linkage to HES and have a recorded Read or ICD-10 code indicative of diabetes mellitus and/or a prescription for a glucose-lowering therapy and no diagnosis indicative of secondary diabetes will be selected. People will be classified as having type 1 and type 2 diabetes using a previously published algorithm1 based on the diagnostic code recorded, prescribed glucose-lowering therapy, age at onset and body mass index (BMI). NHS resource use (primary care consultations, prescriptions, outpatient appointments and inpatient admissions) and associated costs will be characterised across five years (2015 to 2019), chosen to coincide with the most up-to-date linked secondary care data. The linked Hospital Episode Statistics (HES) inpatient and outpatient data will be used to categorise inpatient admissions and outpatient appointments and to provide the information needed to cost these resources using standard NHS costing methods. Healthcare costs will be stratified by sex and 10-year age band and compared between patients with type 1 and type 2 diabetes and the general population without diabetes. Healthcare resource use and costs will also be compared between patients with type 1 and type 2 diabetes and their matched controls with no diabetes. We predict that costs will not have a normal distribution, in which case a non-parametric Mann-Whitney U test will be used to compare costs between those with diabetes and the general population.
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Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tiotropium+Olodaterol or Other Maintenance Therapies in the UK: A Database Study — Alicia Gayle ...
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Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tiotropium+Olodaterol or Other Maintenance Therapies in the UK: A Database Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-07
Organisations:
Alicia Gayle - Chief Investigator - Imperial College London
Jukka Montonen - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
Edward Yu - Collaborator - Aetion, Inc
Elizabeth Garry - Collaborator - Aetion, Inc
Laura Wallace - Collaborator - Boehringer-Ingelheim International GmbHOutcomes:
Primary outcomes
Patient characteristics, include various demographic, lifestyle, clinical, and medication characteristics will be reported at three points in time: 1) COPD diagnosis date (Cohort Entry Date), overall and stratified by before or after Spiolto approval date; 2) Date of initiation of first maintenance therapy (1st Treatment Index Date), overall and stratified by therapy category; 3) Date of initiation of second maintenance therapy (2nd Treatment Index Date), overall and stratified by therapy category.
Secondary outcomes
We will also examine two clinical outcomes over follow-up among individuals who had first and/or second maintenance therapy:
? Exacerbations in the year prior to the start of first maintenance therapy (if available).
? Exacerbations in the year prior to the start of second maintenance therapy (if available).COPD exacerbations will be defined as any of the following:
 An acute COPD exacerbation diagnosis or respiratory failure (READ code ÂH312200Â, Â8BP8.00Â, ÂH3y1.00Â, ÂH590.00Â, ÂH59..00Â, ÂR2y1.00Â, ÂR2y1z00Â);
? A lower respiratory tract infection diagnosis (READ code ÂH060.00Â, ÂH060.11Â, ÂH060300Â, ÂH060500Â, ÂH060w00Â, ÂH060x00Â, ÂH060z00Â, ÂH062.00Â, ÂH06z000Â, ÂH06z011Â, ÂH06z100Â, ÂH06z112Â, ÂH20..11Â, ÂH20y.00Â, ÂH20z.00Â, ÂH22..00Â, ÂH22..11Â, ÂH22y.00Â, ÂH22yz00Â, ÂH22z.00Â, ÂH23..11Â, ÂH24..00Â, ÂH24y.00Â, ÂH24yz00Â, ÂH24z.00Â, ÂH25..00Â, ÂH25..11Â, ÂH26..00Â, ÂH26..11Â, ÂH260.00Â, ÂH261.00Â, ÂH2B..00Â, ÂH2z..00Â, ÂH30..11Â, ÂH300.00Â, ÂH301.00Â, ÂH30z.00Â, ÂH3y0.00Â, ÂH540000Â, ÂH540100Â, ÂHyu0800Â, ÂHyu0A00Â, ÂHyu0B00Â, ÂHyu0H00Â, ÂHyu1.00Â );
? Oral antibiotic or oral corticosteroids prescription on the same or within 7 days following a COPD diagnosis (Chalmers 2018).Description: Technical Summary
Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway obstruction confirmed by spirometry, often including small airway obstruction and emphysema.
For patients who are diagnosed with COPD, maintenance treatments often include bronchodilators, primarily long-acting muscarinic antagonists (LAMA), long-acting beta agonists (LABA), and inhaled corticosteroids (ICS) alone or in combination with each other and corticosteroids. Selective prescribing according to patient characteristics, known as channelling, can lead to bias in comparative studies where drugs with similar therapeutic indications are prescribed to groups of patients with prognostic differences. Claimed advantages of a new drug may be distorted if they are channelled to patients with special pre-existing morbidity, with the consequence that disease states can be incorrectly attributed to use of the drug. Therefore, it is important to describe characteristics of COPD patients treated by Spiolto and characteristics of those treated by other maintenance treatments. In this study we describe various demographic, lifestyle, clinical, and medication use of patients treated with LAMA/LAMA other dual combination than Spiolto, LAMA, LABA, ICS, LABA/ICS or a combination of LABA/LAMA/ICS at the time of diagnosis, at the time of initiation of first maintenance treatment and at the time of initiation of second maintenance treatment.
Source -
The long-term impact of vaginal surgical mesh devices in UK primary care: a cohort study in the CPRD — Emily McFadden ...
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The long-term impact of vaginal surgical mesh devices in UK primary care: a cohort study in the CPRD
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-06
Organisations:
Emily McFadden - Chief Investigator - University of Oxford
Emily McFadden - Corresponding Applicant - University of Oxford
Carl Heneghan - Collaborator - University of Oxford
Georgia Richards - Collaborator - University of OxfordOutcomes:
Four classes of outcomes will be examined, focusing on primary care: comorbidities and quality of life, workload, prescriptions, and complications. These are summarised below, and described in detail in section N (exposures, outcomes and covariates).
Primary outcome:
1. Comorbidities and quality of life:
1.1 depression/anxiety/self harm;
1.2 sexual dysfunction;Secondary outcomes
2.1 Workload - Use of health services:
2.1.1. number of GP appointments by consultation type (e.g. clinic, surgery, emergency, telephone call, visits etc);
2.1.2. number and type of referrals, including to psychological services and pain clinics/services; and
2.1.3 number and type of scans (MRI, CT scans, transvaginal ultrasounds).2.2 Prescriptions:
2.2.1 number of prescriptions for antibiotics; and
2.2.2. number of prescriptions for pain relief (opioids).2.3 Complications
2.3.1. hospital admissions; and
2.3.2 mesh repair/removal surgery
2.3.3 complications of surgery  bladder problemsDescription: Technical Summary
Surgical mesh has been used in urogynaecological procedures to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for the past 20 years. Recent public attention and concerns on complications following mesh in urogynaecological procedures have risen. Such complications may include, pain, infection, depression, anxiety, sexual dysfunction, and further surgery.
The issues with mesh are complex, recommendations differ between national bodies and there is a lack of evidence to inform long term complications.(1) Previous research in the UK has used Hospital Episodes Statistics (HES) data to describe complications (mainly rates of reoperation) related to mesh surgery in the hospital setting. There is a lack of evidence informing comorbidities, workload, prescribing and complications arising in primary care in relation to those who have undergone a procedure.
Therefore this study will use the Clinical Practice Research Datalink (CPRD) linked to HES data to examine the long-term patient outcomes in patients with SUI and/or POP, both with and without surgical mesh implants. Outcomes of interest are grouped into (1) those affecting patient comorbidity and quality of life, such as depression, anxiety and self-harm, and sexual dysfunction, (2) those affecting GP workload, including the number of appointments, referrals, and scans, (3) numbers of prescriptions for antibiotics and for pain relief, and (4) complications. We will describe rates of each outcome stratified by covariates of interest, such as age, body mass index (BMI), parity, those relating to surgery, and other outcomes. We will also fit patient level models (Cox regression for binary variables and, depending on dispersion, Poisson or negative binomial regression for count data) to identify factors that are associated with increased rates of each outcome. Our findings will inform current health policy decisions and shared decision making between patients and clinicians to ensure the safety and management of patients in primary care.
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Equity dynamics of multimorbidity in England over time: a descriptive study on trends of incident and prevalent multimorbidity by age, sex, and socioeconomic status — Chris Kypridemos ...
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Equity dynamics of multimorbidity in England over time: a descriptive study on trends of incident and prevalent multimorbidity by age, sex, and socioeconomic status
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-21
Organisations:
Chris Kypridemos - Chief Investigator - University of Liverpool
Anna Head - Corresponding Applicant - University of Liverpool
Chris Kypridemos - Collaborator - University of Liverpool
Martin O'Flaherty - Collaborator - University of Liverpool
Pieta Schofield - Collaborator - University of LiverpoolOutcomes:
Primary outcomes: incidence and prevalence of basic multimorbidity (two or more chronic conditions); incidence and prevalence of complex multimorbidity (three or more chronic conditions in three or more body systems).
Secondary outcomes include: a) age of onset of 1st condition; b) age of onset of basic multimorbidity; c) age of onset of complex multimorbidity; d) time from onset of 1st disease to onset of basic multimorbidity; e) time from onset of 1st disease to onset of complex multimorbidity; f) number of chronic conditions
All analyses will be stratified by sex, age group, and quintile of the English Index of Multiple Deprivation (IMD) 2010 (as a measure of socioeconomic status).Description: Technical Summary
Background: Multimorbidity is becoming increasingly prevalent in the UK, with higher burden of disease and earlier onset among the more socioeconomically deprived. Multimorbidity poses unique challenges to the provision of primary care and the structure of healthcare systems currently focused around single conditions. Few studies have looked at multimorbidity incidence, trajectories of accumulation, or equity trends over time in England, and those that have tend to focus on older subsets of the population. Furthermore, the majority of studies have used a definition of coexistence of 2 or more diseases from varying predefined lists of chronic conditions.
Objective: to describe the current patterns of coexistence of multiple conditions treated in primary care over the life-course and over time, and how these patterns vary by socioeconomic status
Methods: Two measures of multimorbidity will be used throughout: a) basic multimorbidity: two or more chronic conditions; b) complex multimorbidity: at least three chronic conditions affecting at least three body systems. CPRD data will be linked to the English Index of Multiple Deprivation 2010 to allow analyses by socioeconomic status.
The first stage of this observational descriptive cohort study will calculate the observed incidence and prevalence of multimorbidity by sex, age group, and socioeconomic status over the time period of 2004-2018. We will calculate the median age of onset of initial condition and multimorbidity, along with the median accumulation time from first condition diagnosis to onset of multimorbidity.
In the second stage of the study, we will use survival analysis (parametric or semi-parametric frailty models) to calculate the modelled incidence and prevalence of multimorbidity by sex, age group, and socioeconomic status. Parametric or semi-parametric frailty models will also be used to map trends in age of onset of first incident condition and time of subsequent progression to multimorbidity by sex, socioeconomic status, and initial condition.Primary outcomes: incidence and prevalence of multimorbidity. Secondary outcomes will include: a) age of onset of 1st condition, b) age of onset of multimorbidity, c) time between onset of 1st condition and onset of multimorbidity.
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Adverse childhood experiences: incidence, prevalence, determinants and outcomes across primary and secondary care — Ruth Gilbert ...
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Adverse childhood experiences: incidence, prevalence, determinants and outcomes across primary and secondary care
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-08-27
Organisations:
Ruth Gilbert - Chief Investigator - University College London ( UCL )
Shabeer Syed - Corresponding Applicant - University College London ( UCL )
Ania Zylbersztejn - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Claire Powell - Collaborator - University College London ( UCL )
Estela Capelas Barbosa - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Heng Fan - Collaborator - University College London ( UCL )
Janice Allister - Collaborator - Not from an Organisation
Katie Harron - Collaborator - University College London ( UCL )
Leah Li - Collaborator - University College London ( UCL )
Linda Wijlaars - Collaborator - University College London ( UCL )
Pia Hardelid - Collaborator - University College London ( UCL )
Rebecca Lacey - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Primary outcomes as recorded in maternal/child CPRD/HES-APC/ONS records:
 Child maltreatment (CM), all-cause and cause-specific mortality;
 Adverse childhood experiences/environments (ACEs; e.g. child maltreatment, social service involvement, maternal mental health problems, and other adverse family environments).Secondary outcomes as recorded in maternal/child CPRD/HES-APC records:
 Re-occurrence of ACEs; frequency of ACEs
 All-cause hospitalisations; cause-specific hospitalisations;ACEs and secondary outcomes can be considered as exposures interchangeably, with descriptions provided in section N.
To ascertain applicable code lists, we will prioritise existing phenotypes and validated algorithms. Additional Read and ICD codes will be identified using free-text searches of code dictionaries and by searching online code repertoires. If not already classified, ICD-10 codes will be categorised into broad diagnosis groups using the Clinical Classifications Software (CCS developed by the Agency for Healthcare Research and Quality (AHRQ). The cross-map package by NHS digital will be used to guide combinations of Read and ICD-10 codes for classification of similar diagnoses across sources. The final list of ACEs and health conditions will reflect a refined set of indicators clinically relevant or of public health importance based on prevalence, that have associations with risk factors and outcomes consistent with external evidence and input from a patient and expert stakeholder group co-ordinated by NIHR Children and Families Policy Research Unit (CPRU)
Description: Technical Summary
We aim to develop and validate a set of ACE indicators, and to study the impact of ACEs on future health outcomes and healthcare use in a birth cohort of mothers and children (born 1990-2018). The cohort will comprise the CPRD mother-baby link (MBL), with patients followed from birth to adulthood, and linked to the Hospital Episode Statistics (HES), Index of Multiple Deprivation (IMD), and ONS for mortality data. The project is divided into three parts:
Part I: Refinement and validation
(1) An exploratory study, to refine and classify ACE indicators in CPRD and HES using supervised machine learning techniques such as random survival forests.(2) A cross-validation study, to quantify the overlap and agreement between ACE indicators across HES and CPRD. We will calculate prevalence's, positive predictive values and cross concordances using methods such as the Cohens Kappa statistic to estimate agreement between sources.
(3) A derivation and validation study, using prediction models investigating the association between clinically relevant ACE indicators (e.g. predictors amenable to intervention during a limited time period) and the risk of future adversity (e.g. re-occurrence of child maltreatment). Predictors will be modelled using supervised machine learning techniques, combined with manual multivariable hazard regression models.
Part II: Descriptive study
(4) A descriptive study, to estimate prevalence and, annual incidence rates and attributable economic costs of ACEs in CPRD and HES. Estimates will be stratified by demographics, IMD and overall ACE type.Part III: Hypothesis testing study
(5) An hypothesis-testing birth-cohort study, investigating whether ACEs increase the risk of poor health outcomes among mothers and children later in life, compared to unexposed mother-child pairs. ACEs will be modelled using multivariable cox-proportional hazard models, and outcomes will include psychiatric disorders, chronic conditions, potentially preventable health events (e.g. emergency injury admissions), and all/cause-specific mortality.
Source
2019 - 07
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Meeting the health needs of looked-after children in Scotland — Robert Porter...
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Meeting the health needs of looked-after children in Scotland
Where: unstated
When: 2019-7-24
Opt Outs: no information provided./p>
Who: Robert Porter, University of Strathclyde, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why:
The overall aim of this study is to examine looked after childrenâs use of unscheduled health care in Scotland, comparing those living at home with parents to those living away from home in, for example, kinship care, foster care or residential care. This project aims to use data linked from the Primary Care Out of Hours Service; the Scottish Ambulance Service; A&E (hospital Accident & Emergency); SMR01 inpatients and day cases; NHS24 call data; and local authority data about looked after children.
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Physical healthcare outcomes for people with severe mental illness — unknown...
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Physical healthcare outcomes for people with severe mental illness
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
People with severe mental illness die much younger than people in the general population and this is not explained by high suicide rates in this population. While lifestyle factors such as poor diet and limited physical activity, alcohol and cigarette consumption are contributory, it is accepted that clinical recognition and early intervention are sub-optimal. Better evidence is required to understand contact with hospital services.â¯The study aims to provide evidence about the medical outcomes of people with severe mental illness (SMI).
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Maternal employment in Northern Ireland — Dr Corina Miller...
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Maternal employment in Northern Ireland
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: Dr Corina Miller, Centre for Public Health, Queen's University Belfast (ADR Northern Ireland).
Datasets:see text
Why:
This project aims to maximise the research impact of work from the Administrative Data Research Network (ADRN), ADR UKâs predecessor.
The work examines factors affecting mothersâ return to work (or not) after having children. Using Census data, the researcher was able to discover what impacts whether a mother returns to work after childbirth, including factors like previous employment, education level, age of children, and type of childcare accessed. The project was developed in partnership with the Childcare for All coalition, and the findings launched at a joint conference in March 2019. The Coalition is using the findings from the research in their advocacy for policy changes and the development and implementation of new universal childcare legislation for Northern Ireland. Further follow-up research is planned by the researcher.
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Examining factors relating to adolescent mental health — unknown...
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Examining factors relating to adolescent mental health
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to maximise the research impact of work from the Administrative Data Research Network (ADRN), ADR UKâs predecessor.
Youth mental health is recognised as a global concern due to prevalence rates of 20-25% for mental health disorders in young people.â¯It is important to identify factors contributing to poor youth mental health and achievement to develop and deliver evidence-based interventions in Northern Ireland.
Northern Ireland currently lacks a comprehensive understanding of how socio-economic status (SES) and familial factors impact the mental and physical wellbeing of its youth population. Northern Irish youths have previously been sampled in the Health Behaviours in School-Aged Children (HBSC) study to assess physical and mental wellbeing, but have not been sampled since 1998.
This currently leaves a 20-year gap in understanding of how SES and family circumstances impact adolescent wellbeing in Northern Ireland. This is a considerable gap in understanding due to socio-economic and societal changes taking place in Northern Ireland since 1998; these include increased unemployment and an increase in divorce rates.
The aim of this study will be to explore the relationship between SES, housing and the family unit on adolescent wellbeing in Northern Ireland. This analysis can be achieved by linking Census data with further datasets via data linkage strategies possible through ADR Northern Ireland.
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Multimorbidity and the use of health and social care — David Henderson...
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Multimorbidity and the use of health and social care
Where: unstated
When: 2019-7-24
Opt Outs: no information provided./p>
Who: David Henderson, Edinburgh Napier University, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why:
Multimorbidity â the presence of two or more long term conditions â is increasing in prevalence in Scotland. It has several negative outcomes including higher mortality, decreased quality-of-life, decreased functional status, and higher usage of healthcare. Little is known, however, about the relationship between multimorbidity and social care and how sociodemographic factors influence receipt of care.
The overall aim of this study is to assess whether multimorbidity has an impact on the type and amount of social care people over the age of 65 received between 2011 and 2016 in Scotland, comparing unscheduled healthcare use for those that receive social care in the study period, with those that do not.
The data analysed for this project includes linked data from the Prescribing Information System; the CHI (Community Health Index); the Unscheduled Care Data Mart; deaths records; and the social care survey.
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Unveiling trends in drug-related deaths — Northern Ireland Statistics & Research Agency (NISRA)...
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Unveiling trends in drug-related deaths
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: Northern Ireland Statistics & Research Agency (NISRA), ADR Northern Ireland.
Datasets:see text
Why:
Northern Ireland is experiencing an escalating problem of harm related to substance use, evidenced by rapid increases of deaths attributable to drugs and alcohol in recent years. The research will generate more extensive socio-economic, health and equality group (Section 75) related information to better understand adverse trends in drug and alcohol mortality in Northern Ireland. By addressing some of the gaps in knowledge and providing up-to-date analyses, our project results will guide policymakers and inform public health and health system planning in Northern Ireland.
Source -
Social mobility and health inequalities in Glasgow — unknown...
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Social mobility and health inequalities in Glasgow
Where: unstated
When: 2019-7-24
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project explores whether selective migration explains Glasgowâs poor health and excess mortality. It aims to examine the social mobility of those who stayed with those who moved both in and out of Glasgow. We will look at who moved from Glasgow to regions with New Towns. We will compare the adult health and social class of those who moved with the health of those staying in Glasgow and also those who moved into Glasgow. We hope to use the following data:
The 1947 Scottish Mental Survey (cognitive ability)
National Health Service Central Register (NHSCR) data (health board area, death)
The 2001 census (occupation, education, self-reported general health)
1939 register (early life social class)
This new project will include Census data to provide a fuller analysis of how the places and groups a child grows up in affects their wellbeing in later life.
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Dental and ophthalmic health provision for people with severe mental illness — unknown...
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Dental and ophthalmic health provision for people with severe mental illness
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
There is some but rather limited evidence that the dental and ophthalmic care of people with severe mental illness (SMI) is poor. This is partially explained by the stigma of mental illness and the social exclusion faced by this vulnerable population who often lack the skills, confidence and knowledge necessary for health self-management and negotiating healthcare from other professionals. Using linked prescription, hospital admissions, dental, ophthalmic and mortality data, this proposed study will examine disparities in dental and ophthalmic health between adults with SMI compared to the general hospital population.
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Understanding users of concessionary fares — Dr Jos Ijpelaar...
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Understanding users of concessionary fares
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: Dr Jos Ijpelaar, Northern Ireland Statistics & Research Agency (NISRA), ADR Northern Ireland.
Datasets:see text
Why:
The Northern Ireland public transport Concessionary Fares Scheme was established to promote accessible public transport for members of the community who are most at risk of social exclusion, by providing SmartPasses. The uptake rate for the 60+ SmartPass was 79% in 2018/19; of these holders, 71% used it at least once in that year. These figures have been relatively stable over the past five years.
This research will initially assess robustness of data and associated linkage to the 2011 Census of Population, given this is a new data source within ADR Northern Ireland. Subsequently, it will analyse the profile and rates of uptake and use of SmartPasses by the 60+ population. Findings will contribute to policy aimed at improving the uptake and use of free travel.
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Examining factors relating to adolescent mental health — unknown...
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Examining factors relating to adolescent mental health
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: The aim of this study will be to explore the relationship between SES, housing and the family unit on adolescent wellbeing in Northern Ireland. This analysis can be achieved by linking Census data with further datasets via data linkage strategies possible through ADR Northern Ireland. This study will examine:
Socio-economicâ¯determinants of mental illness among adolescents. Health and social determinants for educationalâ¯and occupationalâ¯outcomesâ¯among adolescents.
Source - and 41 more projects — click to show
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Investigating positive youth development — Professor Chris Dibben...
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Investigating positive youth development
Where: unstated
When: 2019-7-30
Opt Outs: no information provided./p>
Who: Professor Chris Dibben, University of Edinburgh, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why:
Using linked data from the Aberdeen Children of the 1950s study (ACONF) and prescribing data for medicines for mental health, the aim of this project is to examine whether childhood participation in Scouts, Guides and other similar organisations:
1. Is independently associated with better mental health at age 50.
2. Reduces inequalities in adult mental health associated with early life socioeconomic position.
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Care in the last years of life — Dr Anna Schneider...
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Care in the last years of life
Where: unstated
When: 2019-7-30
Opt Outs: no information provided./p>
Who: Dr Anna Schneider, Edinburgh Napier University, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why: What was the household structure of people in the last days of life in 2001 and in 2011, at national and local level?
Did household structure change with proximity to death?
How did the household structures of people in their last days of life at the 2011 Census compare with people who were still alive a year later? How did these differences compare with the situation at the 2001 Census?
To what extent was place of death predicted by living arrangements at the Census preceding death?
Did changes in household structure explain trends in place of death in 2011 relative to 2001 amongst people with cancer, at a national and local level?
What was the impact of household structure (and specifically living alone) on hospital admission patterns prior to death?
Did the effects of household structure differ by place of residence, by socio-economic status, or by socio-demographic status?
What impact does informal care have on health and social care services, specifically with regards to hospital and nursing home admissions?
What were the cost implications to formal care of living arrangements in the final stages of life?
A second phase of the study will then aim to develop understanding of factors influencing the availability of informal care during the final stages of life and how this impacts on formal care use. This will look to (1) explore the extent to which informal care leads to avoidance (or otherwise) of hospitalisations in Scotland, and (2) critically assess whether there is evidence to support a belief that retirement migration markedly increases demands for formal social care in NHS Highland.
You can see a snapshot of the early findings of the work in the 'Data Insights' briefing (November 2019).
The overall aim of this study is to develop understanding of factors influencing the availability and utilisation of formal and informal care in Scotland during the final stages of life, and study trends over time. This project uses linked data from inpatients and day cases; cancer registration; the Prescribing Information System; the CHI (Community Health Index); the 2001 and 2011 Census; and the deaths register.
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Psychological stressâ¯andâ¯occupationalâ¯groups — unknown...
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Psychological stressâ¯andâ¯occupationalâ¯groups
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
This project aims to maximise the research impact of work from the Administrative Data Research Network (ADRN), ADR UKâs predecessor.
This study looks at the social and family determinants of psychological stress in occupational groups in Northern Ireland. The main hypothesis for this study is that differences in the prevalence and types of common mental disorders (CMD) across occupational groupings will be detected. Secondly, the researchers hypothesise that the risk of CMD across occupation types is moderated by family demands and that they will detect a differential association of occupation and family demands on CMD between males and females.â¯â¯
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Placement stability of children in out-of-home care — unknown...
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Placement stability of children in out-of-home care
Where: unstated
When: 2019-7-30
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This study aims to:
Compare annual sequences of placements over seven years of data, from year 2008/09 to 2014/15 for children of all ages. This will allow assessment of whether the patterns and stability of placements have changed over this period.
Produce a series of age cohorts of children starting in the 2008/09 data and follow the trajectories of these cohorts over seven years. This will allow a description of the patterns and stability experienced by these children over a long period of time.
A second phase of the study will then examine the effect of the sequences identified above on childrenâs school attendance and school exclusion rates using the Scottish Governmentâs Attendance and Absence in Scottish Schools and Schools Exclusions data. It will also link to the Scottish Governmentâs Pupils in Scotland Census to provide some additional details of the child (e.g. ethnicity).
The overall aim of this study is to provide a detailed analysis of the longitudinal sequences of placements which looked after children in Scotland experience. This research project will provide the opportunity to assess the extent to which placement sequences have changed over the period in which a range of policy developments affecting looked after children have been implemented. This project has used Looked-After Children data from local authorities in Scotland. This project aims to use Scottish Pupil Census and Looked After Children data.
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Health service use and outcomes in later life — unknown...
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Health service use and outcomes in later life
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why:
With an ageing population, concerns about the provision of health and social care for older people are increasingly important, both fiscally and politically. In a Northern Ireland context, this study will provide an opportunity to examine later-life health inequalities related to service use.
Source -
Understanding social circumstances of the veteran population — unknown...
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Understanding social circumstances of the veteran population
Where: unstated
When: 2019-7-30
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This study aims to:
Evaluate the potential of linking currently available data to provide a basis for research into ex-armed forces personnel. Contribute to the development of reusable data that will be made available to the wider academic community. Contribute to the development of evidence informed policy. âThe wellbeing of veterans is central to our society. I am delighted that our expertise will enable insights into the circumstances and wellbeing of those who have served in the forces. Findings will provide government as well as non-government organisations with evidence that can enable more robust planning that can ensure critical needs are addressed.â Dr Iain Atherton, Reader at Edinburgh Napier University and project leadThis project is funded by ADR Scotland via its core grant from the Economic & Social Research Council (ESRC) as an ADR UK partner.
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Investigating Irish language and Ulster Scots in Northern Ireland — Northern Ireland Statistics & Research Agency (NISRA)...
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Investigating Irish language and Ulster Scots in Northern Ireland
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: Northern Ireland Statistics & Research Agency (NISRA), ADR Northern Ireland.
Datasets:see text
Why:
There is continued interest in Northern Ireland in supporting speakers of Irish and Ulster Scots. The Good Friday Agreement emphasises the importance of respect, understanding and tolerance in relation to linguistic diversity. The research project will assist policymakers in understanding the factors that influence Irish language and Ulster Scots speaking in Northern Ireland. As well as profiling the socio-economic characteristics of Irish and Ulster Scots speakers in 2011, the research will assess change in Irish language speaking between 2001 and 2011. Project results will inform a wider UK collaboration comparing characteristics of Irish and Ulster Scots speakers in Northern Ireland with Welsh language and Scots Gaelige speakers in Wales and Scotland respectively.
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Does commuting affect health? — Dr Zhiqiang Feng...
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Does commuting affect health?
Where: unstated
When: 2019-7-24
Opt Outs: no information provided./p>
Who: Dr Zhiqiang Feng, University of Edinburgh, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why:
The increase in travel distances and the prevalence of car use in commuting have important health implications in addition to financial and environmental consequences. This study aims to explore the association between commuting and health from different angles using objective health measures from NHS health data. The work aims to link data from hospital discharges, the Prescribing Information System, maternity records, psychiatric admissions, Census records, and birth registrations.
Source -
Stability of patterns of care for children in Scotland — unknown...
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Stability of patterns of care for children in Scotland
Where: unstated
When: 2019-7-30
Opt Outs: no information provided./p>
Who: unknown
Datasets:see text
Why: This study aims to:
Compare annual sequences of placements over seven years of data, from year 2008/09 to 2014/15 for children of all ages. This will allow assessment of whether the patterns and stability of placements have changed over this period.
Produce a series of age cohorts of children starting in the 2008/09 data and follow the trajectories of these cohorts over seven years. This will allow a description of the patterns and stability experienced by these children over a long period of time.
A second phase of the study will then examine the effect of the sequences identified above on childrenâs school attendance and school exclusion rates using the Scottish Governmentâs Attendance and Absence in Scottish Schools and Schools Exclusions data. It will also link to the Scottish Governmentâs Pupils in Scotland Census to provide some additional details of the child (e.g. ethnicity).
The overall aim of this study is to provide a detailed analysis of the longitudinal sequences of placements which looked after children in Scotland experience. This research project will provide the opportunity to assess the extent to which placement sequences have changed over the period in which a range of policy developments affecting looked after children have been implemented. This project has used Looked-After Children data from local authorities in Scotland. This project aims to use Scottish Pupil Census and Looked After Children data.
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Reducing economic inactivity in Northern Ireland — Dr Jos Ijpelaar...
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Reducing economic inactivity in Northern Ireland
Where: unstated
When: 2019-7-29
Opt Outs: no information provided./p>
Who: Dr Jos Ijpelaar, Northern Ireland Statistics & Research Agency (NISRA), ADR Northern Ireland.
Datasets:see text
Why:
Northern Ireland has had the highest economic inactivity in the UK for the past 30 years. The economically inactive is the population who are not in employment or seeking employment. There are many reasons why an individual may be inactive â the most common are being in full-time education, looking after family, retirement, or being long-term sick.
Reducing the economic inactivity rate (excluding students) is a key Northern Ireland Programme for Government outcome. A greater understanding of diverse economic inactivity groups is important to support programme interventions aimed at engagement with the labour market.
Key aimsUsing 2001 and 2011 Census data through the Northern Ireland Longitudinal Study (NILS), the focus of this study is to understand groups within the Northern Ireland working age population who changed their economic activity status between 2001 and 2011. Key aspects of the research will be to identify characteristics associated with economic inactivity, looking in particular at:
Those who have been active and move to inactivity, compared to those who remain economically active. Those who have moved from being inactive to active employment, compared to those who remain economically inactive.It will look at indicators of the two most common reasons for inactivity â poor health and caring responsibilities â but also other characteristics such as age, sex, social class, marital status, ethnicity, religion, the household structure, educational qualifications, and employment history.
Source -
Selective schooling and long-term health — Dr Frank Popham...
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Selective schooling and long-term health
Where: unstated
When: 2019-7-30
Opt Outs: no information provided./p>
Who: Dr Frank Popham, University of Glasgow, Scottish Centre for Administrative Data Research (ADR Scotland).
Datasets:see text
Why: Is attending a selective school associated with a different risk of poor health in later life compared to attending a non-selective school? Does the association with selective schooling vary by childhood socio-economic background?
Education is associated with better health. However, it is still unclear whether it has a causal impact. Natural experiment studies allow better assessment of causality. This study uses data from a 1950s Aberdeen birth cohort for whom test score, secondary school attended and later life health are available to test the impact of secondary schooling on health.
Anonymised linkages will be made between the following previously collected datasets:
Data from age six to 12: cognitive test scores; verbal and mathematics tests scores; teachers' assessments; family socio-demographic information (collected as part of ACONF study). Data from mid-life: responses to a survey of physical and mental health, education history, and sociodemographic characteristics (collected as part of ACONF study). Health data: number of chronic conditions derived from diagnoses from hospital admission and mental health inpatient databases from Scottish Medical Records derived by ISD: SMR01 and SMR04.
Source -
Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease: Impact of Study Design Differences on Comparative Safety Results — Susan Jick ...
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Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease: Impact of Study Design Differences on Comparative Safety Results
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-23
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Sarah Charlier - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Jeff Yang - Collaborator - University of North Carolina at Chapel Hill
John Buse - Collaborator - University of North Carolina at Chapel Hill
Robert Sandler - Collaborator - University of North Carolina at Chapel Hill
Tiansheng Wang - Collaborator - University of North Carolina at Chapel Hill
Til Stürmer - Collaborator - University of North Carolina at Chapel HillOutcomes:
Primary outcome: Inflammatory Bowel Disease (IBD) in general
Secondary outcomes: CrohnÂs disease; Ulcerative colitisDescription: Technical Summary
The objective of this study is to implement an active comparator, new user cohort design (ACNU) in CPRD GOLD data to assess the association between dipeptidyl peptidase-4 inhibitor (DPP4i) use and the risk of inflammatory bowel disease (IBD) in patients with diabetes type 2. We will compare our results with a previously conducted study on the same topic (Abrahami et al.) also using the CPRD to analyse the impact of study design differences on comparative safety results.
The study population will include patients aged ?18 years who received ?2 prescriptions for a DPP4i or an active comparator drug (sulfonylurea, SGLT2 inhibitors, or thiazolidinediones) between 01.01.2007 and 31.12.2017. The outcome IBD will be identified through READ codes.
We will use propensity scores to remove imbalances in measured potential confounders between ACNU cohorts and comparator drug initiators. We will follow patients from 180 days after the second prescription of a DPP4i or active comparator (the Âinduction period) until change of treatment status, disenrollment, death, or occurrence of an IBD event. We consider a change of treatment status to be either a discontinuation of index drug class, or a switch to or addition of any study drug class. A person will be considered an exposed case of IBD from the date of a study drug prescription plus 180 days, including after treatment changes (the Âlatent period) to account for diagnostic delay. We will estimate and compare
 the cumulative incidence of IBD for each study cohort using weighted Kaplan-Meier methods
 hazard ratios of IBD in DPP4i users with users of comparator drugs using weighted Cox proportional hazard models.We will use more extensive READ codes for the outcome, and identical READ codes for a sensitivity analysis, than those used by Abrahami et al., to compare results from different study designs.
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Chronic inflammatory conditions and cardiovascular risk — Nathalie Conrad ...
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Chronic inflammatory conditions and cardiovascular risk
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-30
Organisations:
Nathalie Conrad - Chief Investigator - KU Leuven University
Nathalie Conrad - Corresponding Applicant - KU Leuven University
Geert Molenberghs - Collaborator - KU Leuven University
Geert Verbeke - Collaborator - KU Leuven University
Jan Verbakel - Collaborator - KU Leuven UniversityOutcomes:
Chronic inflammatory conditions: The proposed analysis will investigate chronic inflammatory conditions (CIC). These include auto-immune conditions: Chronic inflammatory conditions (CIC): AddisonÂs disease; ankylosing spondylitis; Coeliac disease; Graves disease; Hashimoto thyroiditis; inflammatory bowel disease (Crohn disease and ulcerative colitis); insulin dependent diabetes; multiple sclerosis; myasthenia gravis; psoriasis; polymyalgia rheumatica; primary biliary cirrhosis; pernicious anaemia; rheumatoid arthritis; SjogrenÂs; systemic lupus erythematosus; systemic sclerosis; vasculitis; and vitiligo; as well as other conditions associated with strong and chronic inflammatory load: asthma, chronic obstructive pulmonary disease, gout and osteoarthritis. These diseases were selected in light of their chronic nature and enhanced inflammatory burden, alongside their relatively high prevalence in the general population. Diagnoses will be extracted from patients primary and secondary care records.
Cardiovascular diseases: The proposed analysis will consider the following cardiovascular disorders (CVD): aortic stenosis; aortic aneurysm; cardiac arrythmias; heart failure; ischaemic heart disease; stroke; peripheral arterial disease; venous thromboembolism or pulmonary embolism; and valve disorders. These diseases were selected to broadly reflect the spectrum of CVD. Some of the conditions (e.g. ischaemic heart disease or aortic stenosis) are linked to atherosclerosis for which the involvement of inflammation is well known.21 For others (e.g. atrial fibrillation or aortic aneurysm), influence of inflammation is less well established. Diseases will be considered individually and as a composite outcome of all CVD combined. Diagnoses will be extracted from patients primary and secondary care records.
Cause-specific mortality: The proposed research will investigate cause-specific mortality as recorded in death certificates from the Office for National Statistics (ONS). The cause of death will be defined as the first reported cause in each patientÂs death certificate.
Cause-specific mortality and hospitalisations: The proposed research will investigate hospital admissions from Hospital Episodes Statistics (HES) data. The cause of hospitalization will be defined as the primary discharge diagnosis.Description: Technical Summary
Background: Markers of inflammation are associated with increased risk of cardiovascular disorders. Certain conditions are known to be associated with high and chronic inflammation, yet evidence of increased cardiovascular risk in these patients is limited and differences between conditions have not been compared on a large scale.
Objectives: To quantify the incidence and prevalence of chronic inflammatory conditions (objective 1), to investigate whether patients with chronic inflammatory conditions are at increased risk of incidence (objective 2) and severity (objective 3) of cardiovascular disorders, and to examine how risks vary by individual disease, type of disease, age, and sex.
Study design and setting: Longitudinal population-based study using anonymised electronic health records from
primary care, secondary care, as well as national death registries.
Main outcomes: Chronic inflammatory conditions (CIC): AddisonÂs disease; ankylosing spondylitis; asthma; Coeliac disease; COPD; gout; Graves disease; Hashimoto thyroiditis; inflammatory bowel disease (Crohn disease and ulcerative colitis); insulin dependent diabetes; multiple sclerosis; myasthenia gravis; osteoarthritis; psoriasis; polymyalgia rheumatica; primary biliary cirrhosis; pernicious anaemia; rheumatoid arthritis; SjogrenÂs; systemic lupus erythematosus; systemic sclerosis; vasculitis; and vitiligo. Cardiovascular disorders (CVD): aortic stenosis; aortic aneurysm; cardiac arrythmias; heart failure; ischaemic heart disease; stroke; peripheral arterial disease; venous thromboembolism or pulmonary embolism; and valve disorders.
Methods: (1) incidence and prevalence of chronic inflammatory conditions in the general population; (2) incidence rates of CVD events in patients with and without CIC; and (3) cause-specific 1-year mortality rates following an incident CVD event in patients with and without CIC. Associations between CIC and CVD will be examined using random-effects Poisson regression models accounting for clustering between practices and patient characteristics (incl. age, sex, socioeconomic status, comorbidities, CVD risk factors). Analyses will be performed for individual diseases and stratified by disease category, age, and sex.
Expected outcomes: Identification of high-risk populations may lead to more targeted screening and treatment strategies and improve the prevention of cardiovascular diseases. Differences among diseases may provide important clues about underlying biological mechanisms and inform the design of future research.
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The balance between face-to-face and phone consultations in primary care and its effect on hospital demand: A longitudinal observational study — Stefan Scholtes ...
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The balance between face-to-face and phone consultations in primary care and its effect on hospital demand: A longitudinal observational study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-25
Organisations:
Stefan Scholtes - Chief Investigator - University of Cambridge
Stefan Scholtes - Corresponding Applicant - University of Cambridge
- Collaborator -
- Collaborator -
Harshita Kajaria - Collaborator - University of Cambridge
Michael Freeman - Collaborator - INSEADOutcomes:
Primary outcomes of interest throughout the study: per capita annual number of A&E visits for the practice population; per capita annual number of emergency admissions for the practice population; per capita annual number of emergency bed days for the practice population; per capita annual number of outpatient visits for the practice population.
The capitation (size of registered list) of a practice will be estimated from the observed number of patient consultations in a year, using published average numbers of annual GP patient consultations by age groups (1).
For reporting purposes, we would only specify practices as small/medium/large.Description: Technical Summary
Research Question 1:
Study aim and objectives.
We will study and quantify the relationship between different demand and supply factors as exposure variables, and the ability of the patient to see his regular GP as the main outcome variable. We expect that a combination of increase in demand and a reduction in supply leads to a reduction in continuity of care.Design.
Our design is a longitudinal study that estimates effects of the exposure variable on the outcome variable within practices over time.Statistical methodology.
We estimate this relationship between exposure and outcome variables by first breaking down the demand and supply factors into relevant and meaningful measures, aggregating the measures at the practice-month level and ultimately estimating a longitudinal model, specifically, a fixed-effects panel data model.Research Question 2:
Study aim and objectives.
We will study the relationship between a practiceÂs balance of telephone to face-to-face consultations (ratio of telephone consultations to face-to-face consultations) as the primary exposure variable, and, patients return frequency to the GP practice(number of face to face consultations in the next year), A&E visits, emergency admissions, emergency bed days and outpatient visits (annualized per capita) of registered practice patients as outcome variables. We will use the percentage of consultations with a patientÂs regular GP as a moderator variable to see if relationship between our outcome and primary exposure variables differs.We expect that a lower rate of face to face consultations in the current year may increase the patients return frequency to the practice in the next year. We also expect that a higher rate of face-to-face consultations leads to decreased outpatient activity, but a higher rate of telephone consultations at the expense of face-to-face time, may or may not lead to decreased A&E activity. Since capacity is limited, the tradeoff between telephone and face-to-face time for different patient segments, provided by different healthcare professionals, needs to be well understood. These effects may be more or less pronounced if the practice offers a higher ability for patients to have consultations with their regular GP.
We aim to estimate the relationship between exposure and outcomes and to identify a range of telephone appointment rates that balance the effects on A&E and outpatient activity and lead to low overall secondary care usage. We will break this down by the type of healthcare professional as well as patient segments.
Design. Our design is a hybrid design, estimating cross-sectional and longitudinal effects simultaneously.
Statistical methodology.
We estimate the relationship between exposure and outcomes using the following steps. First, we develop prediction models that allows us to predict the annual expected value of the 5 outcome variables as a function of patient characteristics alone. Second, we calculate for each outcome, a standardized outcome for each practice and year as the ratio of the sum of observed outcomes to the sum of model-predicted outcomes. A GP practice with a ratio below 1 will use fewer secondary care resources than expected for its patient population, a practice with a ratio above 1 will use more. Third, we estimate the relationship between exposure, standardized outcomes and the moderator, using multi-level longitudinal models. We use subsample and interaction models to assess the effects on subpopulations.
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Quantifying the Risk of Type 2 Diabetes Across the UK — Benjamin Feakins ...
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Quantifying the Risk of Type 2 Diabetes Across the UK
Datasets:GP data, Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-17
Organisations:
Benjamin Feakins - Chief Investigator - University of Oxford
Benjamin Feakins - Corresponding Applicant - University of Oxford
Dianna Smith - Collaborator - University of Southampton
Evangelos Kontopantelis - Collaborator - University of Manchester
Richard Stevens - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of Oxford
Tim Holt - Collaborator - University of Oxford
Trisha Greenhalgh - Collaborator - University of OxfordOutcomes:
Risk of type 2 diabetes.
Description: Technical Summary
Effective approaches to diabetes prevention are essential to reduce the human and economic costs of this increasingly common and serious condition. Identifying sub-populations at the highest risk of diabetes could improve targeting of preventative interventions. Validated diabetes risk scores are a simple and scalable way of estimating and comparing risk across different populations; some can be calculated from routinely collected data available on GP clinical computer systems and/or research databases.
The aim of this project, which builds on previous work undertaken by TGÂs team in East London, is to externally validate the recently derived type-2 diabetes risk score, and use it to estimate the 10-year risk of developing diabetes across the UK. We will use the Clinical Practice Research Datalink (CPRD) to obtain patient level risk factor data and estimate diabetes risk using a the QDiabetes-2018 risk score. Traditionally, CPRD has only included data from practices using Vision computer systems. However, CPRD have recently added data from practices using EMIS Web computer systems. Using both data sets, individual risk estimates will be aggregated to form regional summaries and presented as a heat-map of the UK. The availability of data from both Vision and EMIS Web practices means that any heat maps produced will be more representative of the risk in each health region than was previously possible.
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Uncontrolled blood pressure and therapeutic inertia in treated hypertensive patients: a retrospective descriptive cohort study using CPRD — CELINE DARRICARRERE ...
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Uncontrolled blood pressure and therapeutic inertia in treated hypertensive patients: a retrospective descriptive cohort study using CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-23
Organisations:
CELINE DARRICARRERE - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
CELINE DARRICARRERE - Corresponding Applicant - IRIS - Institut de Recherches Internationales Servier
Caroline Louis - Collaborator - IRIS - Institut de Recherches Internationales Servier
Emmanuelle Jacquot - Collaborator - IRIS - Institut de Recherches Internationales Servier
Marc Bénard - Collaborator - AIXIAL
Pauline Macouillard - Collaborator - IT&M Stats
Siham Eltaief - Collaborator - IT&M Stats
Stéphanie HENNEL - Collaborator - IRIS - Institut de Recherches Internationales ServierOutcomes:
Uncontrolled blood pressure; Time to blood pressure control; Therapeutic inertia; BP values; GP consultations; BP records
Description: Technical Summary
Hypertension is defined by a systolic blood pressure (SBP) of 140 mmHg or higher, or a diastolic blood pressure (DBP) of 90 mmHg or higher. It is the leading risk factor for cardiovascular diseases and patients diagnosed as hypertensive can be treated with antihypertensive medications to lower their blood pressure and prevent the onset of such diseases. Globally, guidelines for the management of hypertension such as the NICE (National Institute for Health and Clinical Excellence) guidelines of 2011 or the European Society of Cardiology (ESC) guidelines of 2013 recommend SBP and DBP targets below 140 mmHg and 90 mmHg in adults, as well as SBP and DBP targets below 150 mmHg and 90 mmHg in the elderly. Despite these recommendations and a large therapeutic armamentarium, 33% of the treated hypertensive population aged 45 and over remained uncontrolled in England in 2017 according to the Health Survey for England. Even though annual prevalence of hypertensive control are available, there is a lack of recent information regarding the management of high blood pressure, or the course of the BP values and treatment changes particularly when not restricted to new hypertensive patients.
The overall objective of this study is to describe the course and management of blood pressure over time in treated hypertensive patients in primary care. Uncontrolled BP in adult patients with a diagnosis of hypertension and at least one prescription of an antihypertensive drug between 2016 and 2017 will be quantified. The description of the management of uncontrolled BP will mainly be based on therapeutic inertia and the time needed to reach blood pressure control. Several subpopulations will be described according to the prior use (or not) of antihypertensive medications and/or their blood pressure control status at index date.
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5-Alpha Reductase Inhibitors and the Risk of Anaemia — Samy Suissa ...
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5-Alpha Reductase Inhibitors and the Risk of Anaemia
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-25
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Henok Tadesse Ayele - Collaborator - Merck Sharp & Dohme Corp
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Reem Masarwa - Collaborator - McGill UniversityOutcomes:
Anaemia (overall and by severity)
Description: Technical Summary
5?RIs reduce prostate size among men with BPH by lowering levels of dihydrotestosterone, an androgen that promotes prostate growth. Previous studies have reported that decreased androgen levels are associated with an increased risk of anaemia; however, the anaemia effects of 5?RIs have not been previously assessed in a real-world setting. We will thus conduct a population-based retrospective cohort study using the CPRD to compare the risk of anaemia of 5?RIs versus that of ?-blockers. We will identify all patients with incident BPH in the CPRD from April 1998 to March 2019. Using an active comparator, new-user approach, patients will enter the cohort on their first eligible prescription for a 5?RI or an ?-blocker. In our primary analysis, we will use an as-treated exposure definition and will follow patients until the development of anaemia, discontinuation of the study drug, initiation of the other study drug or combination therapy, or administrative censoring. Secondary outcomes will include different World Health Organization (WHO)-defined categories of anaemia severity: mild (129-110g/l), moderate (109-80g/l), and severe (<80g/l) anaemia. We will match 5?RI users to ?-blocker users and use Cox-proportional hazards models estimate the hazard ratio and 95% CIs for anaemia with 5?RIs versus ?-blockers. In secondary analyses, we will examine the risk by molecule, by the duration of use, and whether any observed increased risk is reversible.
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A retrospective observational cohort study to identify the real-world use of oral glycopyrronium bromide in children — Bhavin Kalola ...
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A retrospective observational cohort study to identify the real-world use of oral glycopyrronium bromide in children
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-09
Organisations:
Bhavin Kalola - Chief Investigator - Ennogen
Pipasha Biswas - Corresponding Applicant - Symogen
Bhanu Rudra - Collaborator - SymogenOutcomes:
·     To understand the safety profile of glycopyrronium bromide in children aged 3-17 years.
Glycopyrronium bromide is a medication of the muscarinic anticholinergic group. Most common adverse events of antimuscarinics agents include constipation, dizziness, drowsiness, dry mouth, dyspepsia, flushing, headache, nausea, palpitations, skin reactions, tachycardia, urinary disorders, vision disorders, and vomiting. Additionally, angioedema and confusion are reported rare or very rarely for these class of drugs.
Hence specific outcomes of interest will include:
 Cardiovascular System (CVS) effects including cardiac dysrhythmia, abnormal ECG
 Central Nervous System (CNS) effects including headache, confusion, restlessness, flushing, pyrexia, frustration, dizziness, abnormal behaviour and drowsiness
 Gastrointestinal effects including constipation, dry mouth, nausea, vomiting, diarrhoea, diarrhoea symptom and dyspepsia
 Hepatic and renal effects including at risk for impaired liver function, liver enzyme abnormal, urinary retention
 Respiratory effects including nasal congestion and pneumonia
 Vision disorders including blurred vision
 Angioedema
 Drug interactions
 Drug overdose
 Use in patients with renal impairment
All adverse events associated with the use of glycopyrronium bromide (including specific outcomes of interest) in the described population will be reviewed as described in Section O (Statistical analysis).Description: Technical Summary
In the context of the glycopyrronium Bromide (1mg/5mL) oral solution marketing authorization application, the MHRA recommended additional information to support safety profile of drug in children. In response to this, the Company (Ennogen Healthcare Ltd.) will conduct a retrospective observational study using CPRD data.
This descriptive study will help the applicant to show that glycopyrronium bromide is a safe medicine for treating severe drooling of saliva in children and adolescents (aged 3-17 years) with conditions affecting the nervous system, such as cerebral palsy and neurogenerative disease.
The study aims to analyse the CPRD data and understand the safety profile of oral glycopyrronium bromide in children aged 3-17 years. The study will mainly focus on any adverse drug events related to drug interactions, anticholinergic, cardiovascular, central nervous system, hepatic and renal effects of oral glycopyrronium bromide.
A descriptive, exploratory statistical analysis will be used to analyse the data, and is generally limited to frequency and incidence rates. The Applicant will consider the correlation and relatedness between glycopyrronium bromide exposure and adverse events. Adverse events frequency and incidence rates will be calculated for each adverse event from the total number of patients who have been exposed to oral glycopyrronium bromide. The frequency of most common adverse events per SOC will be calculated and will be presented in tabular format and graphs. Similarly, severe adverse events and drug-drug interactions relevant for glycopyrronium in general will also be considered. This study will support benefit and risk of the product in regards to its risk and other common and rare adverse events that may have occurred with exposure with glycopyrronium bromide. This will also help healthcare professionals in adequately managing and monitoring of patients in respect to dosing and in further treatment.
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Application of a clinically-driven algorithm for diagnosis of alcohol related liver disease to primary and secondary care cohorts: understanding patient journeys, engagement with healthcare services and associated outcomes — Keith Bodger ...
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Application of a clinically-driven algorithm for diagnosis of alcohol related liver disease to primary and secondary care cohorts: understanding patient journeys, engagement with healthcare services and associated outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-07
Organisations:
Keith Bodger - Chief Investigator - University of Liverpool
Constantinos Kallis - Corresponding Applicant - Imperial College London
Kate Fleming - Collaborator - University of Liverpool
Peter Dixon - Collaborator - University of LiverpoolOutcomes:
Annual incidence rates and period prevalence of alcohol related liver disease (ARLD) in population-based sample of patients with alcohol-related presentations  calculated by including cases drawn from primary care, secondary care and combined datasets; diagnostic code for ARLD assigned to patient in primary or secondary care data or both; disposal method of first unplanned admission for ARLD (discharged alive vs. died in hospital); 7-, 30- and 90-day all-cause readmission following first unplanned admission for ARLD; all-cause mortality following first unplanned admission for ARLD; time to readmission following first unplanned admission for ARLD; time to death following first unplanned admission for ARLD.
Description: Technical Summary
Identifying and characterising patients with specific conditions from routinely collected healthcare datasets requires the generation of code lists, rules and algorithms (diagnostic algorithms). In complex chronic diseases, where patients may present with a multitude of symptoms, signs and disease manifestations, there are significant challenges. We have developed an algorithm for the identification of patients admitted to hospital with alcohol-related liver disease (ARLD) within hospital discharge coding. Compared to the standard approach (focused on a list of six specific primary diagnosis codes), our method identifies almost twice the number of cases and admissions. We wish to validate this algorithm by comparing cases of ARLD identified in hospital data with matched primary care records (and vice versa) and develop a new algorithm (combining data from both primary and secondary care datasets). We will compare estimates of incidence and prevalence using alternative methods to illustrate the implications of employing different methodologies. After optimising the diagnostic algorithm for cohort selection, we will deploy the methodology to examine specific questions about the role of primary care contacts in the year before and after a patientÂs first admissions with ARLD. We will describe patterns of primary care contacts among this patient population and explore associations between contacts with primary care and outcomes of emergency inpatient admissions. Hypotheses will be tested relating to whether Âengagement with primary care is associated with outcomes, and specifically whether patients without evidence of consultations in the community are at highest risk for in-hospital mortality and prospective readmission. This work will inform strategies for stratifying and targeting of high risk cases for preventive action and alternative models of care.
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Variation in healthcare utilisation across primary and secondary care for patients with type 1 and type 2 diabetes — Sarah Deeny ...
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Variation in healthcare utilisation across primary and secondary care for patients with type 1 and type 2 diabetes
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-03
Organisations:
Sarah Deeny - Chief Investigator - The Health Foundation
Richard Welpton - Corresponding Applicant - The Health Foundation
Fiona Grimm - Collaborator - The Health Foundation
Mai Stafford - Collaborator - The Health Foundation
Martin Utley - Collaborator - University College London ( UCL )
Meetali Kakad - Collaborator - The Health FoundationOutcomes:
 Types and level of health care utilisation by diabetes patients
 Quality of diabetes care
 Health care demand projectionsDescription: Technical Summary
Objectives: The main objective of this research is to increase understanding of health care utilisation patterns by patients with diabetes, and understand the relationship between the frequency of diabetes monitoring in hospital outpatient settings and the risk for diabetes-related complications. We will then develop mathematical models to estimate changes in demand for diabetes outpatient care under different policy scenarios, and estimate the time to impact (i.e. attaining a predefined policy goal) for each scenario. This will allow us to translate our findings on health outcomes into actionable policy recommendations.
Methods and data analysis: A cross-sectional study of CPRD patients registered in 2015-2018 with prevalent diabetes. Data on utilisation (including GP and outpatient care) and health outcomes (all-cause and diabetes-related emergency admissions and mortality) will be derived from CPRD and linked Hospital Episode Statistics and ONS mortality records. Association between outpatient care utilisation and health outcomes will be tested for using use multi-level Cox's proportional hazards model, nesting patients within outpatient care providers. This model will control for patient-based, clinical and disease characteristics and other health care utilisation.
We will then develop an analytical model using Markov Chains, based on outpatient utilisation patterns in the data. This operational research technique that has been used successfully in strategic and capacity planning and to explore the effect of changes to ongoing operations. The model will replicate the flow of individual patients through different "states" (where state determined by the frequency of outpatient appointments for that patient). We will use the model to explore the impact of scenarios, such as changing the number of patients entering the outpatient system, or changing discharge rates and/or altering follow up intervals.
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External validation of multivariable dementia risk prediction models in UK adults using routinely-available predictors — Tim Wilkinson ...
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External validation of multivariable dementia risk prediction models in UK adults using routinely-available predictors
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-22
Organisations:
Tim Wilkinson - Chief Investigator - University of Edinburgh
Tim Wilkinson - Corresponding Applicant - University of Edinburgh
Cathie Sudlow - Collaborator - University of Edinburgh
Christian Schnier - Collaborator - University of Edinburgh
Kym Snell - Collaborator - Keele University
Richard Riley - Collaborator - Keele UniversityOutcomes:
Diagnosis of all-cause dementia; Diagnosis of AlzheimerÂs disease; death (as a competing risk)
Description: Technical Summary
In this study we aim to externally validate three dementia risk prediction models in CPRD data.
We have developed two 10-year risk prediction models (one for all-cause dementia and one for AlzheimerÂs disease dementia) using linked primary care, hospital admissions and mortality data from the Secure Anonymised Information Linkage (SAIL) Databank in Wales. The Dementia Risk Score (DRS), developed by Walters et al. (2016) using data from The Health Improvement Network (THIN), aims to predict 5-year all-cause dementia risk.
To externally validate these models, we will use linked primary care, hospital admissions, deprivation and mortality data to create a cohort study, in which follow-up for eligible participants begins on 1/1/2008 (study start date) and ends at the earliest of: dementia diagnosis, death, loss to follow-up or end of follow-up. Predictors will be derived from primary care and hospital admissions data, and dementia outcomes will be ascertained using primary care, hospital admissions and mortality data. Participants will be eligible if aged 60-79 years at study start and are registered in a practice in England or Scotland with up-to-standard follow-up. We will exclude participants with an existing all-cause dementia code in any dataset prior to the study start date. To validate the models we will use the same modelling techniques employed during model derivation  Royston-Parmar flexible parametric models, accounting for the competing risk of death in the models derived from SAIL data, and Cox regression in the DRS model.
We will produce calibration plots and calculate performance statistics for each of the models. We will estimate overall model fit using Cox-Snell R2 and Royston R2D techniques. We will use HarrellÂs C-statistic and the D-statistic to estimate model discrimination. For calibration, we will calculate the calibration slope, produce calibration plots, and calculate expected/observed outcome probabilities at 5 and 10 years.
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Prescribing trends in pediatric outpatients — Samy Suissa ...
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Prescribing trends in pediatric outpatients
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-02
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Claire Lefebvre - Collaborator - McGill University
Ke Meng - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Reem Masarwa - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
Primary:
1. Annual prescription rate of 20 commonly prescribed medication groups, classified by BNF section between 1998 and 2019
2. Total number of yearly prescriptions between 1998 and 2019
Secondary:
1. Prescription rate of PPIs
2. Prescription rate of CNS stimulants and drugs used for ADHD
3. Prescription rate of antipsychotic drugs
Prescription rate of metforminDescription: Technical Summary
Pediatric patients are a heterogeneous population, ranging from preterm new-borns to post-pubertal adolescents. They are considered to be more vulnerable due to physiological differences in pharmacokinetics and pharmacodynamics. Over the last decades, there has been an increase in the prescribing of drugs due to the discovery of new drugs, progress in and survival following pediatric surgery, and changes in clinical guidelines. In addition, there has been an increase in the prevalence of childhood diseases, such as gastrointestinal diseases, neurodevelopmental disorders, and obesity. Given these population-level changes and changes in clinical practice, there is an urgent need to examine prescription drug use in this understudied yet vulnerable population. We will therefore conduct a population-based longitudinal study examining pediatric prescribing patterns in the CPRD between 1998-2019.
The primary endpoint will be annual prescription rates for drugs classified according to British National Formulary (BNF) sections. We will estimate each annual prescription rate and corresponding 95% confidence interval (CIs) using Poisson regression overall and in subgroup analyses defined by age, sex, and index of multiple deprivation categories. Secondary endpoints will include annual prescription rates for proton pump inhibitors (PPIs), central nervous system (CNS) stimulants and drugs used for ADHD, antipsychotics, and metformin. We will specifically examine prescribing trends for the first three categories due to concerns regarding potential adverse effects reported in the literature and to facilitate planning subsequent safety studies regarding these medications. We will examine prescribing trends for metformin due to the increase in the worldwide prevalence obesity among children. A study examining prescribing patterns will provide crucial information on changing prescribing trends among pediatrics. This information may assist us in exploring future safety concerns of medications commonly used in pediatrics and identify medications that require post-marketing surveillance in this vulnerable population.
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Effectiveness of Pneumococcal Polysaccharide Vaccine booster dosing in preventing pneumococcal disease in adults in the United Kingdom: a database cohort study — Neil French ...
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Effectiveness of Pneumococcal Polysaccharide Vaccine booster dosing in preventing pneumococcal disease in adults in the United Kingdom: a database cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-25
Organisations:
Neil French - Chief Investigator - University of Liverpool
Klara Doherty - Corresponding Applicant - University of Liverpool
Daniel Hungerford - Collaborator - University of Liverpool
Kate Fleming - Collaborator - University of Liverpool
Laura Bonnett - Collaborator - University of Liverpool
Natalie Beveridge - Collaborator - University of Liverpool
Valerie Decraene - Collaborator - Public Health EnglandOutcomes:
Primary outcomes: Pneumonia hospitalisation.
Secondary outcomes: Invasive Pneumococcal Disease (IPD) hospitalisation; primary care pneumonia consultations; all-cause hospitalisation; all-cause mortalityDescription: Technical Summary
Objective: To evaluate the effectiveness of multiple doses of the polysaccharide vaccine (PPV23) for preventing pneumococcal disease, hospitalisations and deaths in ?65 year olds.
Methods: We will perform an historical cohort study using routinely collected health surveillance data. We will use the Clinical Practice Research Datalink (CPRD) to extract a cohort of ?65 year olds between 2006 and 2018 who have received at least one PPV23 dose. We will use CPRD data and Health Episode Statistics (HES) discharge diagnosis coding to establish pneumococcal disease events including hospitalised pneumonia, hospitalised Invasive Pneumococcal Disease and pneumonia in primary-care. Possible cofounders will be identified from CPRD database including pneumococcal clinical at risk conditions, smoking status, alcohol misuse, frailty and influenza and shingles vaccine status. Furthermore we will investigate possible heterologous effects associated with the interaction between inactivated pneumococcal and live shingles vaccine, through the measurement of all-cause mortality (recorded in CPRD) and hospitalisation rates for any cause.
Data Analysis:
We will described the characteristics of patients receiving 1 versus 2+ PPV23 doses including age, geography, presence of comorbidity, month and year. We will run a comparison of disease rates between patients who have received 1 versus 2+ doses of PPV23. For investigating heterologous effects of combinations of live and inactivated vaccines we will compare mortality and hospitalisation rates in patients who have received 1+ doses of PPV23 only with those received 1+ doses of PPV23 and 1+ doses of shingles vaccine.
Hazard ratios will be derived from a cox regression time-to-event analysis and incidence rate ratios from multi-variable Poisson regression (IRR) and we will incorporate multi-level random effects to account for the time-varying variables. Hazard ratios and IRR will be used as measures of vaccine effectiveness.
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Prevalence of established cardiovascular disease in patients with type 2 diabetes mellitus in the UK — Dominik Lautsch ...
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Prevalence of established cardiovascular disease in patients with type 2 diabetes mellitus in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-17
Organisations:
Dominik Lautsch - Chief Investigator - Merck & Co., Inc.
Dominik Lautsch - Corresponding Applicant - Merck & Co., Inc.
Lingfeng Yang - Collaborator - Merck & Co., Inc.
Tongtong Wang - Collaborator - Merck & Co., Inc.Outcomes:
We aim to identify the proportion of patients who have either individual condition:
Prevalence of the following diseases within type 2 diabetes %
Post myocardial infarction
Post ischemic stroke/TIA
Peripheral artery disease
Heart failure
Angina pectoris
Coronary artery disease
Any of the above conditions ("established cardiovascular disease")We will further determine if there are differences in the group of patients with established cardiovascular disease over those without with regards to:
Age (years of age, in years)
Gender (% of male gender; assessed: male, female)
Kidney function (estimated glomerular filtration rate in ml/min/1.73 m2 body surfaced as found in the records. Displayed as % of patients in the respective classes of international KDIGO classification  CKD1, 2, 3a, 3b, 4, 5  and as a median with IQR).
Most recent LDL-cholesterol values (mmol/L, mean and 95% CI)
Most recent systolic and diastolic blood pressure values (mmHg, median and IQR)
Most recent HbA1C (%A1C, mean and 95%CI, as well as patients with A1C in the fixed categories <7%, <8%, <9%, >=9%)
Smoking status (patients who had ever smoked in their life, %).Description: Technical Summary
Acknowledging the results of recent cardiovascular outcomes trials in diabetes patients with superiority of the tested intervention in patients with established cardiovascular disease, we aim to identify the percentage of type 2 diabetes mellitus patients who have established cardiovascular disease in the UK.
Our objective is to describe the prevalence of established cardiovascular disease including stroke and TIA (cerebrovascular disease), myocardial infarction, peripheral artery disease, coronary artery disease and heart failure within the cohort of patients with type 2 diabetes in the United Kingdom.
This is a retrospective database study from the CPRD database.
We will analyse data from adults (>/=18 years of age) patients with type 2 diabetes in the UK.
There is a one year index period to identify eligible patients and a minimum of one year look back period. All available medical records prior to and including the index date will be examined.
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Investigating capacity for NICE guidance on recognition and referral for suspected cancer — Sarah Price ...
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Investigating capacity for NICE guidance on recognition and referral for suspected cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-10
Organisations:
Sarah Price - Chief Investigator - University of Exeter
Sarah Price - Corresponding Applicant - University of Exeter
Justin Matthews - Collaborator - University of Exeter
Sarah Bailey - Collaborator - University of Exeter
Sarah Chowienczyk - Collaborator - University of Exeter
Sarah Moore - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
Primary outcomes: The proportions of patients in England eligible for any of the following investigations for suspected cancer:
1. An urgent two-week-wait referral;
2. A direct GP request for any of the following investigations:
a. chest X-ray;
b. ultrasound;
c. computed tomography (CT) scan;
d. magnetic resonance imaging (MRI) of the head; or
e. endoscopy.
Note: We are not identifying codes for the testing itself  instead examining eligibility based on a personÂs recorded cancer features.
Secondary outcomes: the incidence of cancer in the year after meeting criteria for each of the above investigations.Description: Technical Summary
In this study, we will provide a robust estimate of the likely numbers of people in England presenting in primary care who are eligible for investigation because they have symptoms of possible cancer. Eligibility is guided by the NICE 2015 Suspected Cancer Recognition and Referral Guidelines (NG12). The number of two-week-wait referrals for suspected cancer is increasing year on year, with no sign of levelling out. Direct investigation for possible cancers is also increasing relentlessly. An estimate of the likely maximum number of annual appointments and direct investigations would help to improve capacity and workforce projection planning by the Department of Health, both for existing and future planned services.
We will study a representative sample of 200,000 adults aged 40 or over who are registered with general practices in England in the Clinical Practice Research Datalink (CPRD). We will use existing lists of medical codes to estimate how many patients have symptoms, signs or abnormal blood test results (from hereon called "cancer features") that warrant referral or direct investigation according to the NICE NG12 guidelines. We will then use publicly available population data from the Office for National Statistics to estimate the total number of adults aged 40 and over in England who are eligible for referral or investigations. We will also use publicly available data from Public Health England to estimate the current numbers of urgent two-week-wait appointments, to quantify unmet need.
As a secondary analysis, we will examine the one-year incidence of cancer in people eligible for cancer investigation (equivalent to the positive predictive value for each NICE recommendation). This is important to help with any future revision of NICE guidance, particularly with the recent Government suggestion that the 3% risk threshold warranting urgent investigation for cancer should be lowered.
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Association of serum bilirubin level with renal outcomes in patients with type 2 diabetes and patients with essential hypertension — Dinko Rekic ...
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Association of serum bilirubin level with renal outcomes in patients with type 2 diabetes and patients with essential hypertension
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-09
Organisations:
Dinko Rekic - Chief Investigator - Astra Zeneca R&D Molndal Sweden
Yasunori Aoki - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Claudia Cabrera - Collaborator - Astra Zeneca R&D Molndal Sweden
Peter Greasley - Collaborator - Astra Zeneca R&D Molndal SwedenOutcomes:
1)Â Â Â Â Time to eGFR CKDEPI 30% decrease from the baseline;
2) Time to first observation of proteinuria;
3) Time to first observation of albuminuria.Description: Technical Summary
Recent investigations and meta-analyses indicate a strong association between bilirubin and renal outcomes. We wish to conduct a retrospective study on CPRD GOLD dataset to investigate these associations in a real-world setting. Based on our preliminary feasibility count, we believe the cohorts retrospectively built using CPRD GOLD dataset will be at least one order of magnitude larger than the analyses that are currently available. Also, we should be able to adjust critical confounders such as haemoglobin level and smoking status that was previously not done or lead to inconclusive results.
We will retrospectively build two cohorts with known risk factors for CKD: type 2 diabetes or hypertension. We will follow the patients from the date of diagnosis of either of these morbidities to one of the events indicating the degradation of renal function (eGFR decrease, serum creatinine increase, albuminuria, or proteinuria). We will fit the Cox proportional hazard models with inverse probability weighting to estimate the adjusted hazard ratio between the patients with elevated bilirubin vs. normal levels.
We are aware that as this will only be the observational study and we will not be able to conclude the causality of bilirubin levels to CKD progression even if we can show an association. However, with careful analyses based on richer dataset than what is currently available, this analysis may increase our understanding of the association between bilirubin and CKD outcomes and guide further investigations
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Suspected cancer symptoms and blood test results in primary care before a diagnosis of lung cancer: a case-control study — Alex Simpson ...
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Suspected cancer symptoms and blood test results in primary care before a diagnosis of lung cancer: a case-control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-25
Organisations:
Alex Simpson - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Alex Simpson - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political ScienceOutcomes:
 Smoking status
 BMI
 Haemoptysis
 Fatigue
 Shortness of breath
 Chalson Comorbidity index
 Cough
 Chest pain
 Weight loss
 Basophil count
 Eosinophil count
 Lymphocyte count
 Monocyte count
 Neutrophil count
 Platelet count
 C-reactive protein (CRP)Description: Technical Summary
Objectives
Compare symptoms and blood test results captured by general practitioners in the two years prior to cancer diagnosis in individuals who developed lung cancer and those that did not.Methods
This will be a nested case-control study using data collected within the United Kingdom's Clinical Practice Research Datalink (CPRD). Cases (lung cancer patients) will be matched to up 4 controls with no record of cancer by sex, age, general practitioner (GP) practice and year of registration. The two-year period prior to cancer diagnosis will be stratified into 2-month time windows, and suspected cancer symptoms as well as blood test (basophil, eosinophil, lymphocyte, monocyte, neutrophil platelet and C-reactive protein) results will be identified for cases and controls. Proportions of patients reporting symptoms and mean test results for all individuals having a test in the time window will be compared between cases and controls, and multivariable logistic regression will be used to assess the association between blood tests and symptoms and lung cancer diagnosis.Data analysis
Appropriate descriptive statistics will be used to summarise relevant clinical characteristics (Section O). These will be categorised to reflect lung cancer status.Univariable and multivariable logistic regression models will be used to estimate odds ratios comparing the odds of each event between cases and controls.
Data sets(s) to be used
- CPRD GOLD
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Use of the STarT Back Screening Tool for Low Back Pain in Primary Care — Krysia Dziedzic ...
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Use of the STarT Back Screening Tool for Low Back Pain in Primary Care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-30
Organisations:
Krysia Dziedzic - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Adrian Chudyk - Collaborator - Keele University
Harry Scarbrough - Collaborator - City University London
James Bailey - Collaborator - Keele University
Kay Stevenson - Collaborator - Keele University
Simon Wathall - Collaborator - Keele University
Yaru Chen - Collaborator - City University LondonOutcomes:
Recorded use of the STart Back tool in primary care
Description: Technical Summary
Back pain may lead to persistent disabling symptoms, low quality of life, and reduced capacity to work. Effective treatments exist but there is variability in how they are provided in primary care. The Keele STarT Back Screening Tool is a brief (9 item) tool designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. Patients are allocated to treatment pathways based on their prognosis (low, medium, or high risk of poor outcome) as determined by the STarT Back tool. It has been shown to be clinically and cost effective and is endorsed by the National Institute for Health and Care Excellence, Public Health England and the NHS. Keele University's "Impact Accelerator Unit" has implemented STarT Back with the aim to scale its use up nationally. In collaboration with EMIS, we have developed a template for use in general practice which allows completion of the STarT Back tool. Codes are entered into the medical record when the template is fired and to record responses to the items included in the STarT Back tool. The template is expanding in use within UK practices using EMIS software. However it is unclear how often the STarT Back tool is used, nor how this varies by patient characteristics and geographical region. This study aims to determine how frequently the tool is used in primary care, how this has changed over time, and whether its use varies by patient demographics and geographical region. We will use the AURUM database to determine practices who use the tool and within these the percentage of patients with a coded record of low back pain who also have a record of use of the STart Back tool. We will assess associations with patient's age, gender, multimorbidity and calendar time.
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Trends in Prescription of Antihypertensive Medications in UK Primary Care Practices, 1988-2018 — Samy Suissa ...
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Trends in Prescription of Antihypertensive Medications in UK Primary Care Practices, 1988-2018
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-25
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Emily McDonald - Collaborator - McGill University
James Brophy - Collaborator - McGill University
Julie Rouette - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Tibor Schuster - Collaborator - McGill UniversityOutcomes:
The measured outcomes will be the annual number of patients with a prescription for each antihypertensive drug overall, by age group and by sex; crude and age-adjusted annual prevalence proportion, difference in prevalence and ratio of prevalence for each antihypertensive drug overall; crude annual prevalence proportion, difference in prevalence and ratio of prevalence between the years 1988 and 2019 only for each antihypertensive drug by age group and by sex. The crude and adjusted annual prevalence proportion, difference in prevalence and ratio of prevalence between the years 1988 and 2019 will also be calculated for each antihypertensive drug class.
- We will add the annual prevalence of each antihypertensive drug by selected comorbidities.
- We will add a trajectory analysis of patients with hypertension.
- The age-adjusted annual prevalence proportion will not be included.
- The difference in prevalence and ratio of prevalence analyses will not be specifically tabulated.Description: Technical Summary
Antihypertensive drugs are one of the most commonly prescribed drugs worldwide. Few comprehensive studies exist that explore the prescription patterns of these drugs in UK clinical practices; most are either outdated, limited in scope, or too broad to accurately describe the prescription trends of antihypertensive drugs. An updated, comprehensive study describing prescription trends is currently needed. We will address this gap by using the UK CPRD to examine the annual prescription trends of antihypertensive drugs between April 1, 1988 and April 1, 2019. Crude and adjusted prescription rate and corresponding 95% confidence intervals will be determined using Poisson regression, and annual prescription rates will be stratified by age, sex, and type of antihypertensive drug class.
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A non-interventional retrospective study in England and Scotland estimating the economic burden of moderate-to-severe chronic pain due to osteoarthritis (OA) or chronic low back pain (CLBP) — Christoph Lohan ...
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A non-interventional retrospective study in England and Scotland estimating the economic burden of moderate-to-severe chronic pain due to osteoarthritis (OA) or chronic low back pain (CLBP)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-30
Organisations:
Christoph Lohan - Chief Investigator - Pfizer Ltd - UK
Robert Wood - Corresponding Applicant - Adelphi Real World
Birol Emir - Collaborator - Pfizer Ltd - UK
Daniel Bluff - Collaborator - Adelphi Real World
David Andrew Walsh - Collaborator - University of Nottingham
Deepa Malhotra - Collaborator - Pfizer Ltd - UK
Greg Coates - Collaborator - Pfizer Ltd - UK
Hannah Haswell - Collaborator - Pfizer Ltd - UK
Jessalyn Kemp - Collaborator - Not from an Organisation
Liz Hennessy - Collaborator - Adelphi Real World
Shuk-Li Collings - Collaborator - Pfizer Ltd - UKOutcomes:
GP appointments (all-cause and OA/CLBP-related); Outpatient visits (all-cause and OA/CLBP-related); Hospitalisations (all-cause and OA/CLBP-related); A&E visits (all-cause and OA/CLBP-related); Direct healthcare costs (all-cause and OA/CLBP-related); Demographics (age, sex, ethnicity, region); Clinical characteristics (body mass index, weight, comorbidities, age at diagnosis); Treatment patterns (drug/class prescribed, treatment dynamics, number of lines of therapy received and adverse events of treatments); Incidence of OA; Incidence of CLBP; Prevalence of OA; Prevalence of CLBP; OA/CLBP-related surgery (time to surgery)
Description: Technical Summary
Objectives: The primary objective of this study is to describe the total healthcare resource utilisation (HCRU) and direct healthcare costs associated with moderate-to-severe chronic pain due to osteoarthritis (OA) or chronic lower back pain (CLBP) in England and, where feasible, Scotland.
Methods: This study will be a retrospective, longitudinal cohort study, with comparator group, of OA and/or CLBP patients indexed on a moderate-to-severe chronic pain event between December 2009 and November 2018, inclusive. Moderate-to-severe chronic pain events will include pain-related referrals/visits to secondary care (rheumatology, orthopaedics, pain management or Accident and Emergency [A&E]), prescriptions of pain medications (opioids or non-steroidal anti-inflammatory drugs) and surgical procedures for the treatment of pain in OA and/or CLBP. Each patient within the study cohort (cases) will be matched to at least one general population control with no record of an OA or CLBP diagnosis. For this study, data within the Clinical Practice Research Datalink will be linked to Hospital Episode Statistics (specifically, inpatient, outpatient and A&E data) to comprehensively assess HCRU and associated direct healthcare costs, and the Mental Health Data Set to explore aspects of social care utilised within the study cohort.
Data analysis: This study will be predominantly descriptive in nature, with all outcomes reported using appropriate descriptive statistics, and outcomes compared statistically between cases and controls, where applicable, using standard unpaired statistical tests. In addition, generalised linear models will be constructed to assess potential predictors of weak and strong opioid use, and higher direct healthcare costs, whilst Kaplan-Meier estimates will be calculated to assess time to first OA/CLBP-related surgery.
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Use, risk-benefits, and costs of preventive therapies in older people with complex health needs: an analysis of NHS routinely collected data — Daniel Prieto...
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Use, risk-benefits, and costs of preventive therapies in older people with complex health needs: an analysis of NHS routinely collected data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-07
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Danielle Robinson - Collaborator - University of Oxford
Eng Hooi Tan - Collaborator - University of Oxford
Leena Elhussein - Collaborator - University of Oxford
Ruth Keogh - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tetsuro Oda - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Victoria Y Strauss - Collaborator - University of Oxford
Ying HE - Collaborator - University of Oxford
Yuchen Guo - Collaborator - University of OxfordOutcomes:
ADRs and preventable events: upper gastro-intestinal ulcers, acute kidney injury, liver failure, myopathy, falls, fractures, and cardiovascular events; NHS costs
Description: Technical Summary
OBJECTIVES
1. To characterise older patients with complex health needs;
2. To determine their use of preventive therapies, and to study the risk-benefit and costs associated with the use of such therapies amongst them.METHODS
- Data sources: CPRD GOLD linked to HES-ONS.
- Participants: aged 65+ on 1/1/2009, registered in CPRD for 1+ years (Objective1). Three cohorts: 1.high healthcare resource use, 2.frailty, and 3.polypharmacy (Objective2)
- Exposures: Bisphosphonates, statins, and anti-hypertensivesANALYSIS:
- Patients complexity characterised as number of hospital admissions (healthcare resource use), frailty (eFI), and number of different drug prescriptions (polypharmacy)
- Incidence and prevalence of preventive treatments will be estimated in each cohort. Persistence and medication possession ratios will be calculated.
- We will model the risks according to treatment use with survival analyses adjusted using inverse probability weighting.
- We will estimate rates of Âpreventable events and calculate incidence rate ratios for on- vs off-treatment periods using self-controlled case series.
- We will develop a cost model mapping the care and events pathways and populate it to estimate NHS costs associated with continuing vs stopping the preventive therapies.
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Changes in Healthcare Resource Use (HRU) and Related Costs in Chronic Obstructive Pulmonary Disease (COPD) Patients over 9 years: A France/UK comparative study — Jennifer Quint ...
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Changes in Healthcare Resource Use (HRU) and Related Costs in Chronic Obstructive Pulmonary Disease (COPD) Patients over 9 years: A France/UK comparative study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-03
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Eric Van Ganse - Collaborator - PELyon
Faustine Dalon - Collaborator - PELyon
Manon Belhassen - Collaborator - PELyonOutcomes:
1)Â Â Â Â Healthcare utilisation each year (number and length of hospitalisations, prescriptions received, and associated costs)
2) COPD managementDescription: Technical Summary
Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic respiratory symptoms and persistent airflow limitation, due to cigarette smoking in the vast majority of cases. In patients of 40 years old or more, the prevalence of spirometry-confirmed COPD has been estimated at 7.5% in France in 2008, while there are approximately 4% of people diagnosed with COPD in the UK Â 60% to 85% of people with COPD, mainly with mild-to-moderate disease, remain undiagnosed. Epidemiological studies report a gradual increase in the prevalence in most countries. In 2030, it is estimated that COPD could be the third leading cause of death worldwide. An average of 18,000 deaths per year have been recorded in France over the period 2000-2011, while approximately 30,000 people in the UK die of COPD annually. It is important to understand how COPD is managed and how healthcare resources are used to better understand and inform on the benefits and limitations of different clinical approaches of COPD management. This can lead to improved COPD care, COPD symptoms, and quality of life both nationally and internationally.
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Investigating overlapping pregnancy episodes in the Clinical Practice Research Datalink / London School of Hygiene and Tropical Medicine Pregnancy Register, with the aim of identifying and categorising validity issues. — Jennifer Campbell ...
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Investigating overlapping pregnancy episodes in the Clinical Practice Research Datalink / London School of Hygiene and Tropical Medicine Pregnancy Register, with the aim of identifying and categorising validity issues.
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-14
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachael Williams - Collaborator - CPRDOutcomes:
Pregnancy records relating to the antenatal, perinatal and postnatal period, and the pregnancy outcome in order to further understand which of the overlapping pregnancies in the Pregnancy Register are correct.
Description: Technical Summary
The Pregnancy Register algorithm generates a list of all pregnancies determined in the Clinical Practice Research Datalink (CPRD). A record in the register represents a pregnancy episode and includes information on pregnancy start and outcome. However, there are approximately half a million pregnancies which overlap with another pregnancy in the Register. Scenarios have been identified based on the algorithmÂs logic and how the data is structured which may explain this. The scenarios describe four problems; Both pregnancies are real but one episode is a historical pregnancy; Both pregnancies are historical; Both pregnancies are real but the gestation of the pregnancies applied by the algorithm is wrong; The pregnancies are really one pregnancy which has been identified as two by the algorithm. Descriptive analysis will use an algorithmic approach to query CPRD data and linked datasets to look for supporting evidence for each of these scenarios. Potential reasons for why overlapping pregnancies may have been generated by the algorithm will be tabulated. This work follows on from a previous study which assessed pregnancies without an outcome recorded in the Register (ISAC 17_285R_2) Evidence from these studies will then be used to improve the Pregnancy Register algorithm to reduce the occurrence of overlapping pregnancies and increase the usefulness of this resource.
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Natriuretic peptide testing in diagnosing heart failure in primary care (DIAGNOSE-NP) — Clare Taylor ...
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Natriuretic peptide testing in diagnosing heart failure in primary care (DIAGNOSE-NP)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-07
Organisations:
Clare Taylor - Chief Investigator - University of Oxford
Clare Taylor - Corresponding Applicant - University of Oxford
Andrea Roalfe - Collaborator - University of Oxford
José M. Ordóñez-Mena - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes:
Aim 1: Number of NP tests per 100 person-years, including the subtype (BNP/NT-proBNP) and NP level, in the primary care record (see Code List Appendix)
- Aims 2-3: Incident heart failure (primary) and hospitalisation around time of diagnosis (secondary).
Patients with a diagnosis of HF will be identified using diagnostic codes entered by GPs to record new diagnoses in the primary care (CPRD GOLD) medical record within 6 months of NP testing.HF is a clinical syndrome and the diagnosis requires the presence of symptoms and objective evidence of a structural or functional abnormality of the heart. Patients with a clinical code of HF in their primary care record will be included. Patients with either an echocardiograph report or a record of HF in linked HES records within 3 months of the HF diagnostic code entry in the primary care record will be classified as being hospitalised around the time of diagnosis.
Echocardiograms will be identified using clinical codes and entity code 342. Two distinct types of HF are now recognised by researchers and the clinical community based on the left ventricular ejection fraction: HF with reduced Ejection Fraction (HFrEF) and HF with preserved Ejection Fraction (HFpEF). We will search for these codes in the patient record, and ejection fraction results from echocardiogram reports (entity 342) to establish whether it is possible to report HFrEF and HFpEF separately.- Aim 4: Hospitalisation within 12 months.
Date and cause of hospitalisation will be taken from HES data.- Aim 5: Time to death (all-cause mortality).
Date and cause of death will be taken from ONS mortality data. Secondary outcomes to be reported descriptively, will include primary cause of death and death due to HF (any position in the cause of death hierarchy)Description: Technical Summary
Heart failure (HF) is a common and costly condition affecting 1-2% of adults. Guidelines recommend GPs carry out a natriuretic peptide (NP) test to aid diagnosis in people with suspected HF. The aim of this study is to report the contemporary use of NP testing in UK general practice, determine the level of NP associated with a HF diagnosis and explore the association of baseline NP level and survival.
We will conduct an open retrospective cohort study using data from CPRD for the period between 1st January 2000 and 31st December 2018, linked to Hospital Episode Statistics and Office for National Statistics mortality data.
Our results will include: 1. Frequency of NP testing by year, geographical area and demographic details including age, sex, socioeconomic group; 2. NP levels associated with a HF diagnosis (including hospitalisation around time of diagnosis); 3. Guideline-defined thresholds for NP-testing to determine the proportion of patients meeting guideline recommendations for diagnosis; 4. Survival analysis to compare mortality by baseline NP level. We hope this work will allow us to have a better understanding of NP-use in the community for both diagnosis and prognosis.
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Comparative effectiveness of gliclazide MR and sitagliptin as second line treatment after metformin monotherapy in uncontrolled type 2 diabetes patients using the UK Clinical Practice Research Datalink (CPRD) database — Cortese Viviana ...
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Comparative effectiveness of gliclazide MR and sitagliptin as second line treatment after metformin monotherapy in uncontrolled type 2 diabetes patients using the UK Clinical Practice Research Datalink (CPRD) database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-23
Organisations:
Cortese Viviana - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Alice Rouleau - Collaborator - IRIS - Institut de Recherches Internationales Servier
Briana Coles - Collaborator - University of Leicester
Emmanuelle Jacquot - Collaborator - IRIS - Institut de Recherches Internationales Servier
Kamlesh Khunti - Collaborator - University of Leicester
Pauline Macouillard - Collaborator - IT&M Stats
Siham Eltaief - Collaborator - IT&M Stats
Valerie Lehner-Martin - Collaborator - IRIS - Institut de Recherches Internationales ServierOutcomes:
HbA1c; hypoglycaemia; durability; persistence.
Description: Technical Summary
The study design is a matched cohort of new users of gliclazide MR or sitagliptin for T2D in second line treatment after metformin monotherapy. High-dimensional propensity score will be used to match patients (ratio 1:1) between those initiated on gliclazide MR and those initiated on sitagliptin. The analysis will include adult T2D patients using the UK Clinical Practice Research Datalink (CPRD) database. The study population consists of patients initiating a treatment with gliclazide MR or sitagliptin between 1st January 2010 and the latest available data capture. Initiation of treatment is defined as having at least 2 consecutive prescriptions of gliclazide MR or sitagliptin without a gap >/=90 days, the first prescription defining the cohort entry date. Only patients having received metformin as first-line therapy will be included. Patients with continuous enrolment in the database one year prior to the cohort entry and having an HbA1c lab value >/=7% in the 6 months before cohort entry will be included. Patients will be excluded if they had Type 1 Diabetes, other forms of secondary diabetes or gestational diabetes mellitus. Study period will be until the latest available data capture using GP/ONS/HES linked data. HbA1c assessment window starts at day 60 after cohort entry and ends 30 days after end of durability (defined as index treatment duration until switch/add-on/stop). Outcomes will be defined using UK primary care data (CPRD GOLD and HES). Primary outcome is achieving a target of HbA1C level <7.0%. Proportional hazard models will be used to estimate hazard ratios (HRs) with 95% confidence intervals of the HbA1c outcome with the use of gliclazide MR versus sitagliptin. Secondary outcomes are as follows: reduction of HbA1c level >/= 1% compared to baseline value, achieving a target of HbA1c level </= 6.5%, incidence rate of hypoglycaemia, durability and persistence of index treatments.
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Data analysis of patients with major depressive disorder at imminent risk for suicide in the United Kingdom — Tom Denee ...
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Data analysis of patients with major depressive disorder at imminent risk for suicide in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS); ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-07
Organisations:
Tom Denee - Chief Investigator - Janssen Pharmaceuticals UK
Juliette Murris - Corresponding Applicant - Amaris
Aline Gauthier - Collaborator - Amaris
Astrid Foix Colonier - Collaborator - Amaris France
Cicely Kerr - Collaborator - Janssen Pharmaceuticals UK
Claire Fischer - Collaborator - Amaris
Gemma Scott - Collaborator - Janssen Pharmaceuticals UK
Sarah Richards - Collaborator - Janssen Pharmaceuticals UKOutcomes:
Incidence, demographic and clinical characteristics, comorbidities and time to discharge for hospitalised MDD patients with imminent risk of suicide; a comparison of demographic and clinical characteristics with MDD patients without imminent risk of suicide; healthcare resource use; suicidality risk levels; mortality; level of depressive symptoms (using PHQ-9).
Depending on the data availability: treatment pathway and predictive factors for mortality in MDD with imminent risk of suicide.Description: Technical Summary
We will conduct a descriptive, retrospective, longitudinal cohort study to estimate the incidence and characterise major depressive disorder (MDD) patients who are at imminent risk for suicide in England.
Clinical Practice Research Datalink (CPRD) data linked to Hospital Episode Statistics (HES) data, Mental Health Data Set (MHDS) data, and Office for National Statistics (ONS) data will be used. The overall study duration will be 140 months, from April 2007 to December 2018. The period from April 2007 to November 2015 corresponds to the linkage coverage period of MHDS. The study period will be expanded until December 2018 to have a longer follow-up to assess some of the outcomes. The index date will be defined as the date of the first recorded suicide intention. For patients with an initial suicide intention prior to their MDD diagnosis, subjects will be considered as MDD patients if they have a diagnosis of MDD within three months of this episode of suicide intention. This delay will allow patients whose MDD is first diagnosed following a suicide attempt or an episode of suicide intention to be recorded as MDD patients in the database, as for hospitalised patients diagnosis recording is often not done imminently. Descriptive statistics on demographic/clinical patients characteristics, healthcare resource use, admissions in mental health teams and pharmacological/interventional and non-pharmacological treatment patterns will be generated at index date, at MDD diagnosis and during follow-up. Continuous variables will be described based on mean, median, standard deviation, minimum and maximum values and number of non-missing cases. For categorical variables, we will provide the number and percentage of patients for each modality and the proportion of missing data. Statistical tests will also be conducted to compare characteristics of MDD with and without imminent risk of suicide (Chi-square tests and StudentÂs t-tests for respectively qualitative and quantitative characteristics). Predictive factors associated with mortality in MDD patients at imminent risk for suicide will be investigated using logistic regression models adjusted on characteristics at index date.
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Impact of hospitalisation on Potentially Inappropriate Prescribing in older patients: a retrospective cohort study — Patrick Redmond ...
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Impact of hospitalisation on Potentially Inappropriate Prescribing in older patients: a retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-17
Organisations:
Patrick Redmond - Chief Investigator - King's College London (KCL)
Patrick Redmond - Corresponding Applicant - King's College London (KCL)
Mariam Molokhia - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Vibhore Prasad - Collaborator - King's College London (KCL)Outcomes:
The outcome is prevalence of PIP assessed using a subset (n=45) of criteria from the full Screening Tool for Older Persons Prescription (STOPP) version 2 (7,8).
For each patient, we will calculate the total number and dates of first occurrence of distinct potentially inappropriate prescribing criteria. We will report these as recurrent events (e.g. number of distinct potentially inappropriate prescribing criteria met) and as a dichotomous variable (at least one potentially inappropriate prescription).
STOPP has been used extensively in research as a process of care measure. It has been associated with ADEs, emergency department visits and hospital admissions (9Â12). The use of a subset applied to a database is based on our previously published work based on likely availability of drug and disease coding information (e.g. absence of clinical indication) (2,8,11).
Description: Technical Summary
Background and rationale
Older patients are more likely to be prescribed multiple medications, have multiple chronic conditions, and experience increasing number of transitions of care. A recent meta-analysis reported potentially inappropriate prescribingÂs (PIP) impact on ADEs, health related quality of life and hospitalisation. It is less clear what impact transitions of care have in generating PIP post discharge.Objectives
To examine the association between hospital admission and potentially inappropriate prescribing, and to compare the prevalence of potentially inappropriate prescribing before and after hospitalisationDesign:
A retrospective cohort study utilising Hospital Episodes Statistics and CPRD. A multi-level logistic regression analysis will be performed to examine the association between PIP and hospitalisation comparing those experiencing hospitalisations and those not hospitalised.
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Real world data on utilisation and safety of Movicol paediatric plain among children <2 years — Saad Shakir ...
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Real world data on utilisation and safety of Movicol paediatric plain among children <2 years
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-07-22
Organisations:
Saad Shakir - Chief Investigator - Drug Safety Research Unit
Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Bharat Amlani - Collaborator - Norgine
Elizabeth Lynn - Collaborator - Drug Safety Research Unit
Fatma Akriche - Collaborator - Norgine
Vicki Osborne - Collaborator - Drug Safety Research UnitOutcomes:
 Reasons for consultations during primary care treatment to identify all adverse events [including potential risks (e.g. fluid/electrolyte shifts, including hyperkalaemia and hypokalaemia) listed in the Risk Management Plan], as well as listed events in the SmPC including allergic reactions (including anaphylactic reaction), dyspnoea, allergic skin reactions (including angioedema, urticaria, pruritus, rash, erythema), electrolyte disturbances (particularly hyperkalaemia and hypokalaemia), headache, abdominal pain, borborygmi, diarrhoea, vomiting, nausea, anorectal discomfort, abdominal distension, flatulence, dyspepsia, peri-anal inflammation and peripheral oedema
 Hospitalisation details occurring during treatment and recorded by the primary care physician will be identified from the Referral file and reasons for consultations. In addition, the Referral file and reasons for consultations will be explored to identify potential sequelae of adverse events related to electrolyte disturbances, abdominal pain, peripheral oedema, diarrhoea and vomiting
 Dose and duration of treatment
 Demographics of patients
 Prior medical history (reasons for consultations)
 Test results at baseline and during treatment
 Exploratory analyses of efficacy outcomes identified from reasons for consultations during primary care treatment and/or test results during treatment (exploratory analyses will be undertaken as there is likely to be a significant level of missing information related to efficacy outcomes)Description: Technical Summary
This cohort study will assess the use of Movicol paediatric plain in children under 2 years and its safety profile during treatment.
All patients that have been prescribed Movicol paediatric plain will be identified and the safety profile will be analysed.
Categorical data will be presented as tabulations; continuous data will be described using appropriate summary statistics. Reasons for consultations will be tabulated using grouping based on clinical code levels to allow for patterns to be identified and quantified as individual recording variation may preclude signal detection. Incidence risks will be calculated for safety events.
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Understanding recurrent exacerbations of COPD — Royal Brompton Hospital...
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Understanding recurrent exacerbations of COPD
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-19
Opt Outs: no information provided./p>
Organisations: Royal Brompton Hospital
Description: COPD. Academic
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Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in North West London — West London NHS Trust...
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Flagging of the West London personality disorder patient data into the WSIC data set and extraction of data on personality disorder cohort in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-19
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Mental Health. Academic
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Quality of Secondary prevention following percutaneous coronary interventions in North West London — Royal Brompton Hospital...
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Quality of Secondary prevention following percutaneous coronary interventions in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jul-19
Opt Outs: no information provided./p>
Organisations: Royal Brompton Hospital
Description: Coronary Disease. Academic
Source
2019 - 06
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Stroke incidence among people with heart failure and atrial fibrillation — Clare Taylor ...
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Stroke incidence among people with heart failure and atrial fibrillation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-17
Organisations:
Clare Taylor - Chief Investigator - University of Oxford
Nicholas Jones - Corresponding Applicant - University of Oxford
Andrea Roalfe - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes:
The primary outcome measure:
- Incidence of stroke, including type of stroke classified as either ischaemic or haemorrhagic (including either subdural, extradural or other e.g. subarachnoid).
The secondary outcomes measures include:
- All-cause mortality and cardiovascular mortality, including mortality rates related to HF, AF or stroke.
- Incidence and type of major haemorrhage, including either intracerebral or gastrointestinal
- Incidence of transient ischaemic attack (TIA)
- Proportion of eligible patients prescribed anticoagulation, the type of anticoagulation used, (i.e. whether a vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC)) and the factors associated with high and low rates of anticoagulation prescribing.Additional information on further relevant covariates that will be included are given in Section N below.
Description: Technical Summary
Heart failure (HF) and atrial fibrillation (AF) are common conditions that often co-exist - around 0.5% of the UK adult population have both. Each is independently associated with an increased stroke risk. In combination, the risk is higher still, but there is considerable variation between previous estimates of effect. Anticoagulation is recommended for patients with HF and AF and can reduce stroke risk by 65%. However, in AF, anticoagulation is not prescribed in one third of eligible patients.
The aim of this study is to determine the stroke incidence, mortality and rate of major haemorrhage for patients with HF and AF, compared to either condition alone or neither condition. We will compare current rates of anticoagulation against national guidelines within these groups and identify factors associated with low rates of anticoagulation prescribing.
We will conduct a retrospective cohort study using CPRD data from 1st January 2000 to 31st December 2018, using a time-dependent analysis to account for the fact people will change between groups over follow-up. Incident cases will be recorded at entry to the study cohort and with each subsequent new diagnosis of either AF or HF. Data will be linked to Hospital Episode Statistics to validate diagnostic codes and Office for National Statistics for mortality data.
A survival time analysis will describe stroke incidence over time in each of the four groups (HF, AF, HF+AF, no HF/AF) alongside cumulative incidence plots of survival rates. Multivariable Cox regression modelling will assess the association between HF, AF and time to stroke based on key variables, adjusting for anticoagulation, co-morbidities and the individual components of the CHA2DS2VASc stroke risk score.
The data collected will be used to inform a health economic analysis, using Markov modelling to predict the comparative clinical and cost effectiveness of future alternative treatment strategies to improve anticoagulation.
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Treatment cut-offs for blood pressure lowering and lipid lowering treatment: a cohort study in UK primary care — Rod Jackson ...
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Treatment cut-offs for blood pressure lowering and lipid lowering treatment: a cohort study in UK primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-18
Organisations:
Rod Jackson - Chief Investigator - University of Auckland
Emily Herrett - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Catherine Ludden - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Griffiths - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Cardiovascular disease (coronary heart disease, cerebrovascular disease, peripheral arterial disease, heart failure);
Target organ damage: chronic kidney disease, left ventricular hypertrophy, hypertensive retinopathy, dementia;
Prescription of blood pressure lowering medicationsDescription: Technical Summary
In the UK, blood pressure guidelines recommend use of blood pressure lowering drugs for patients with blood pressures of 160/100mmHg and above, irrespective of their absolute cardiovascular disease risk. However, there is little evidence to justify this cut-off because the relationship between blood pressure and CVD events is log linear.
Similarly, NICE guidelines for lipid lowering drugs (statins) recommend specialist investigation when total cholesterol is 9mmol/L, or non-HDL cholesterol is above 7.5mmol/L, irrespective of absolute cardiovascular disease risk. As with blood pressure, the evidence base for these cut-offs is unclear.
Crucially, among thousands of people in the UK, the blood pressure cut-off determines eligibility for drugs that can reduce the risk of cardiovascular disease by 20%, and cholesterol cut-offs determine whether further health care is provided. Making decisions about which patients to treat should be guided by evidence.
Therefore this study aims to determine whether there are levels of either blood pressure or cholesterol above which treatment is justified. Using data from UK primary care, we will generate a cohort of patients without cardiovascular disease, and stratify them by their predicted absolute cardiovascular disease risk, blood pressure and cholesterol at cohort entry. We will follow them up and observe the rate of cardiovascular disease and target organ damage in each stratum. This will provide evidence about whether there should be cut offs at which treatment or further investigation are warranted, irrespective of risk.
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Identifying trajectories of progression of frailty in elderly individuals — Alan Silman ...
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Identifying trajectories of progression of frailty in elderly individuals
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-11
Organisations:
Alan Silman - Chief Investigator - University of Oxford
Victoria Y Strauss - Corresponding Applicant - University of Oxford
Andrew Clegg - Collaborator - University of Leeds
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Danielle Robinson - Collaborator - University of Oxford
Leena Elhussein - Collaborator - University of Oxford
Sara Khalid - Collaborator - University of OxfordOutcomes:
Outcomes:
- Primary: the primary outcome will be all cause mortality, defined as death recorded in the ONS Death Registration Data.
- Secondary: unplanned hospital admission. The decision to use CPRD or HES records of unplanned admission will be assessed after a comparison of the reporting in the two datasets.Description: Technical Summary
This work, funded by an RfPB grant, aims to extend the utility of the electronic frailty index (eFI), recently introduced into the NHS.The eFI score currently is a simple count of the number of deficits (maximum 36), which include symptoms/signs (e.g. dizziness), abnormal lab values of anaemia, disability (e.g. housebound) to diseases (e.g. arthritis). Using this score, we aim to identify patterns of trajectories of developing frailty in the population aged over 65. We will mine routine primary care data to identify such trajectory patterns and validate these against the subsequent risk of a number of adverse outcomes.
The work comprises 3 phases:
1. Anonymised primary care electronic health record data from the CPRD GOLD database of 225,264 participants with available data from January 1 2009, aged 65+, of which approximately 60% are linked to HES, will be extracted. We will then calculate the cumulative Âcrude number of deficit variables based on the eFI rules. In each of the successive four years, any increase in the cumulative number of the deficits based on the new recording of any previously unrecorded variable will be captured. Distinct patterns of the five year trajectories will then be derived using both latent class growth analysis and growth mixture modelling.
2. These trajectories will be tested in a second primary care database, CPRD Aurum, to examine their reproducibility and, we will also explore the types of the individual patient profiles fit with these
3. We will then explore the association between the emerging distinct frailty trajectories with the adverse outcomes of mortality, and unplanned hospitalization, using both cohorts over the subsequent three years of follow-up.
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Repurposing Drugs for the Prevention and Treatment of Dementia — Ioanna Tzoulaki ...
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Repurposing Drugs for the Prevention and Treatment of Dementia
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-24
Organisations:
Ioanna Tzoulaki - Chief Investigator - Imperial College London
Ioanna Tzoulaki - Corresponding Applicant - Imperial College London
Bang Zheng - Collaborator - Imperial College London
Bowen Su - Collaborator - Imperial College London
Lefkos Middleton - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College London
Roy Welsch - Collaborator - Massachusetts Institute of Technology
Stan Neil Finkelstein - Collaborator - Massachusetts Institute of TechnologyOutcomes:
The outcome of interest is the incidence and progression of any dementia or dementia attributable to AlzheimerÂs disease. We will sequentially add definite or probable dementia cases using the list of diagnoses from the CPRD dataset, then complementing it with data from the Hospital Episode Statistics (HES), and potentially using additional algorithm-derived cases.
For instance, using CPRD data, patients will be considered to have dementia if they had a dementia diagnosis based on Read codes or if they were prescribed with anti-dementia drugs (donepezil, galantamine, rivastigmine, or memantine). Additional information from HES and other linked datasets on mental tests, neuroimaging assessments, and referrals to neurological specialists will also be used to ascertain the suspected cases.
The event date of dementia onset will be defined as the first-time diagnosis date or the first-time prescription date, whichever came first. The time period of dementia progression will be defined by the time elapsed between the timing of AD onset and the timing of the first prescription in the anti-psychotic class.Description: Technical Summary
This study aims to examine whether already approved drugs for other diseases can be used to lower the risk of dementia and AD and/or slow disease progression. We will conduct a retrospective longitudinal cohort analysis with data on drugs (e.g., metformin) and the diagnosis/progress of dementia. Our outcome of interest will include participants with a diagnosis of dementia or prescriptions to dementia specific medications. We will examine associations between drugs of interest and risk of dementia using several statistical approaches such as Cox regression. For each candidate drug, we will implement a robust synthetic matching with distance measures based on propensity scoring estimated using relevant confounders including: age at initial prescription, gender, deprivation index, smoking status, body mass index, and comorbidities (e.g., cardiovascular diseases, depression, cancer, COPD, chronic kidney disease). We plan to refine matching by using modern methods of dealing with high-dimensional data such as Lasso and other penalized methods. Our goal is to balance the need to obtain observed treatment and control groups that have similar covariate distributions with the fact that, in some situations, one or both of the observed treatment and control groups may not allow matching using all available covariates. We will investigate the impact of missing values and different approaches to dealing with missing values including imputation methods and deep learning approaches.
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Treatment patterns among new users of maintenance asthma medications in the United Kingdom — Daniel Gibbons ...
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Treatment patterns among new users of maintenance asthma medications in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-11
Organisations:
Daniel Gibbons - Chief Investigator - GSK
Daniel Gibbons - Corresponding Applicant - GSK
Bhumika Aggarwal - Collaborator - GSK
Chanchal Bains - Collaborator - GlaxoSmithKline - UK
David Hinds - Collaborator - GSK
David Price - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jolyon Fairburn-Beech - Collaborator - GSK
Monica Fletcher - Collaborator - GSK
Sinthia Bosnic-Anticevich - Collaborator - University Of SydneyOutcomes:
Healthcare resource utilisation, acute exacerbations of asthma, changes in asthma maintenance therapy.
Description: Technical Summary
This study will utilise a retrospective cohort. New users of maintenance asthma medication will be identified between January 1, 2013 through December 31, 2015. The first new use prescription for a maintenance medication during this period will be the index prescription.
New use will be defined as no prescription for maintenance asthma medication in the 12 months prior to index. New users will be grouped into three cohorts: new use of (1) an inhaled corticosteroid and long acting bronchodilator (ICS/LABA), (2) an ICS, or (3) an oral maintenance medication.
Descriptive statistics will be utilized to characterize the cohorts of new users regarding demographics, comorbidities, healthcare resource use, exacerbations, and selected clinical characteristics at index. The index medication will be described by inhaled corticosteroid component and inhalation device where applicable. Treatment patterns in the 24 months (follow-up) after initiation for each cohort, including the most common treatment sequences, time to changes in and discontinuation of therapy. Descriptive statistics will quantify health care resource use and exacerbations during the follow-up.
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Trends in diabetes-related complications and cause of death in patients with diabetes in England — Jonathan Pearson...
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Trends in diabetes-related complications and cause of death in patients with diabetes in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-05
Organisations:
Jonathan Pearson-Stuttard - Chief Investigator - Imperial College London
Jonathan Pearson-Stuttard - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Edward Gregg - Collaborator - Imperial College London
Eszter P Vamos - Collaborator - Imperial College London
James Bennett - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Majid Ezzati - Collaborator - Imperial College LondonOutcomes:
Incidence of diabetes-related complications:
Acute Myocardial Infarction
Coronary artery bypass graft
Primary cutaneous intervention
Stroke (ischaemic and haemorrhagic)
Chronic Obstructive Pulmonary Disease
Nephropathy
End stage Renal disease
Non-traumatic lower extremity Amputation
Peripheral neuropathy
Retinopathy
Dementia
All cancer and site-specific cancerCause-specific mortality
Malignant neoplasm of liver and intrahepatic bile ducts
Malignant neoplasm of colon, rectosigmoid junction and rectum
Malignant neoplasms of digestive organs except liver and intrahepatic bile ducts or colorectal
Malignant neoplasms of lymphoid, haematopoietic and related tissue
Malignant neoplasm of trachea, bronchus and lung
Malignant neoplasm of prostate
Malignant neoplasm of breast
Malignant neoplasm of cervix
Malignant neoplasm of pancreas
Malignant neoplasm of endometrium
All other neoplasms
Respiratory
Diabetes
Acute Myocardial Infarction
Other ischaemic heart disease
Stroke (cerebrovascular)
Liver disease
Renal failure
Other circulatory
Intentional Injury - Self-harm
Unintentional Injury
Dementia and AlzheimerÂs DiseaseDescription: Technical Summary
Aim, Study, Design, key variables, analytical method
This study aims to estimate the trends in diabetes-related complications and cause of death in patients with diabetes in England 1998-2017 and compare with the non-diabetes population.Study design
This study uses a historical open cohort study to develop an analytic, dynamic cohort to examine age-specific incidence and mortality rates and compare between the diabetes and non-diabetes population. We will estimate the trends in diabetes related complications and cause of death in patients with diabetes over a 20-year period and then compare incidence and mortality rates and rate ratios with the non-diabetes population.The exposure of interest is diabetes (both type 1 and type 2 diabetes) and key outcomes of interest are diabetes-related complications, including microvascular and macrovascular disease, cancer and dementia and cause-specific mortality, including microvascular and macrovascular disease, cancer, dementia, chronic lower respiratory disease, chronic liver disease, respiratory failure including due to pneumonia, influenza, sepsis, intentional self-harm and accidents.
The primary cohort is those with diabetes (type 1 or type 2) in each of the 20-years in the study to identify diabetes-related complications and cause of death during follow up. We will additionally have a non-diabetes cohort to provide comparison (rate ratios) with the diabetes population.
The primary analytic method will be discrete Poisson regression with year, age at follow up and event status (for diabetes-related complication, not for mortality) as time dependent variables. Key outcome measures will include incidence rate, mortality rate, and rate ratios comparing the diabetes and non-diabetes populations.
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Evaluation of the ePACT2 national polypharmacy prescribing indicators — Rupert Payne ...
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Evaluation of the ePACT2 national polypharmacy prescribing indicators
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-04
Organisations:
Rupert Payne - Chief Investigator - University of Bristol
Deborah McCahon - Corresponding Applicant - University of Bristol
Evangelos Kontopantelis - Collaborator - University of Manchester
Gary Abel - Collaborator - University of Exeter
Rachel Denholm - Collaborator - University of BristolOutcomes:
Outcomes will vary by different ePACT2 indicators, and are detailed in Section N. In general, the key outcomes are:
 Potentially inappropriate prescribing
 Medication regimen complexity
 Medication adherence
 Hospitalisation admission
 DeathDescription: Technical Summary
Polypharmacy is a major challenge for primary care and can lead to several adverse consequences. Routine primary care prescribing data can be used to identify various aspects of inappropriate prescribing relevant to polypharmacy. These so-called Âprescribing indicators can facilitate the targeting and monitoring of medication optimisation. Although several sets of indicators (e.g. STOPP/START) can be incorporated into GP clinical systems, they cannot be implemented using the national ePACT prescription dispensing data used by most commissioners to evaluate local prescribing practices. A recent upgrade known as ePACT2 has allowed the development of more sophisticated prescribing metrics. This includes indicators designed specifically to address the issue of polypharmacy.
The objective of this study is to evaluate the utility of the ePACT2 indicators.
We will conduct a retrospective cohort analysis using data from the Clinical Practice Research Datalink (CPRD) on 300,000 patients. We will evaluate the practice case-mix associated with ePACT2 indicators, and the criterion validity with respect to association with key relevant clinical outcomes (inappropriate prescribing, medication adherence, medication complexity, unplanned admissions, death).
The six ePACT2 indicators (number of unique medicines per patient, prescription of ?8 medicines, anticholinergic burden score ?6, multiple prescription of anticoagulants and antiplatelets, prescription of ?2 medicines likely to cause kidney injury, prescription of an NSAID with ?1 medicine likely to cause kidney injury) will be operationalised in CPRD.
Mixed-effect logistic regression models with the covariates of age, sex, socio-economic deprivation, practice size, multi-morbidity score, relevant co-morbidities and concomitant medication will be used to evaluate case-mix associated with the indicators.
Multivariable Poisson/negative binomial/logistic regression analysis, as appropriate, will then be used to model the association between the indicators and relevant clinical outcomes.Findings will be essential for informing the effective implementation of the ePACT2 polypharmacy indicators in order to best inform prescribing practice and policy.
Source -
Prescribing Patterns of Opioid Analgesics in Primary Care among CPRD Patients — Esther Zhou ...
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Prescribing Patterns of Opioid Analgesics in Primary Care among CPRD Patients
Datasets:GP data, Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-06
Organisations:
Esther Zhou - Chief Investigator - Food and Drug Administration - FDA
Esther Zhou - Corresponding Applicant - Food and Drug Administration - FDA
Grace Chai - Collaborator - Food and Drug Administration - FDA
Jana Mcaninch - Collaborator - Food and Drug Administration - FDA
Judy Staffa - Collaborator - Food and Drug Administration - FDA
Rose Radin - Collaborator - Food and Drug Administration - FDA
Xiaoqing Huang - Collaborator - Food and Drug Administration - FDA
Zhou Feng - Collaborator - Food and Drug Administration - FDAOutcomes:
The main study outcome is analgesics prescribing rate by year. We will estimate opioids refill patterns, treatment duration, and concomitant medications in incident prescribing cohort. Refill patterns are featured by patterns of allowable gaps and overlaps between prescriptions. Treatment duration is defined by total quantity and number of days.
We will also evaluate the concomitant medications prescribed together with opioids over the years. Drugs of interest include benzodiazepines and gabapentinoids. Concomitancy is defined as any medication overlapped at least one day with opioid analgesics.Description: Technical Summary
Opioid analgesics are usually used to relieve moderate to severe pain. Despite many common side effects, the major fear concerning opioid analgesics is related to life-threatening side effects of abuse and addiction.
Increased rates of opioid-related misuse and overdose death have emerged as a national crisis in the US recent years. In the UK, a similar trend of increasing opioid prescriptions has been observed, while the increase in overdose death related to opioids was obviously less significant.
Our overall objective for this project is to evaluate the prescribing trend of opioid analgesics, in both pediatric and adult patients over more than two decades. We have three specific aims. Aim (1), we will evaluate prevalent opioid analgesics prescribing patterns and the trend changes over time. For Aims (2) and (3), we will establish incident prescribing cohort, also called new user cohort. Aim (2), we will first evaluate incident opioid analgesics prescribing patterns and the trend changes over time. For the new pediatric and adult patient cohorts, we also propose to estimate opioid analgesics refill patterns, treatment duration, and concomitant medications. For specific aim (3), we propose to estimate potential risk factors associated with incident opioid prescribing, e.g. age, gender, health status, social economic status, alcohol and smoking histories, concomitant medications, and related pain diagnoses. In addition, we will compare prescribing patterns for (1) opioid versus non-opioid analgesics; (2) strong-opioids versus weak-opioids, and (3) long-term versus short-term opioid analgesic therapy.
We will use a retrospective cohort study design for the time-period from January 1, 1995 through December 31, 2018, using the CPRD GOLD data. The exposures are analgesics. The outcome measures are proportions and prescribing rates of analgesic prescriptions. To estimate potential factors associated with incident opioid prescribing, logistic regression will be utilized.
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Real world costs of blindness for patients with inherited retinal dystrophies (IRDs): a non-interventional study using primary and secondary healthcare databases in the United Kingdom — Carly Rich ...
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Real world costs of blindness for patients with inherited retinal dystrophies (IRDs): a non-interventional study using primary and secondary healthcare databases in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-19
Organisations:
Carly Rich - Chief Investigator - Harvey Walsh Ltd
Mark Evans - Corresponding Applicant - OPEN Health Group
- Collaborator -
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
David Heaton - Collaborator - Harvey Walsh LtdOutcomes:
Primary endpoints:
Total number of hospital spells with a diagnosis of ICD-10 H355, outpatient appointments, A&E attendances by type; Spells and outpatient appointments where the treating specialty is ophthalmology; Spells where depression is a comorbidity; Spells where an ophthalmology procedure is performed; A&E attendances related to ophthalmology; A&E attendance for fracture, Length of hospital spells and total bed days (including excess bed days; Total and average cost; Cost of spells with ophthalmology procedures; Number of GP ophthalmology interactions with RP and LCA patientsSecondary endpoints:
Total number of patients diagnosed with RP and LCA by year of diagnosis and age at diagnosis; Incidence of newly diagnosed patients diagnosed with RP and LCA by year of diagnosis and age at diagnosis; Patient baseline demographics (age at diagnosis, gender); Total number of hospital spells by type and department of admission by age at diagnosis; Length of hospital stays and total bed days; Total and mean; Complications and readmissions; Number of GP contacts for ophthalmology; Prescribing review for ophthalmology; Prescribing review for depressionDescription: Technical Summary
A major cause of early-onset blindness, inherited retinal dystrophies (IRDs) include conditions such as retinitis pigmentosa (RP) which represents the largest patient group and Leber Congenital Amaurosis (LCA) which is often described as the most severe form of IRD.
Novartis is the manufacturer of voretigene neparvovec, (Luxturna) an adeno-associated virus (AAV) vector-based gene therapy for the treatment of biallelic RPE65 mutation-associated inherited retinal dystrophies (IRD). Biallelic RPE65-mediated IRDs are a group of rare eye disorders which occur when there are mutations in both alleles of the RPE65 gene which is linked to retinal pigment epithelium (RPE) cells.
This study aims to assess resource use and associated costs for patients with IRD to support the cost effectiveness analysis required for health technology assessment by the National Institute for Health and Care Excellence (NICE). The study will be descriptive. Patients with RP or LCA (2008-2018) will be identified by Read code in the CPRD primary care dataset and date of first onset will be identified as the index date. The number of primary and secondary care contacts post-index date will be aggregated. Primary care contacts will be costed with costs derived from the Units Costs of Health and Social Care. Secondary care activity will be processed using HRG groupers, and mapped to the relevant National Tariff. Length of inpatient stay will also be presented. In addition, activity relating specifically to ophthalmology will be flagged by relevant codes and aggregated. Prescriptions emanating from primary care will be aggregated from the therapy table and costed based on the net ingredient cost derived from Prescribing analysis and cost tabulation (PACT) data. Those indicated for ophthalmological complications and depression will be flagged. The incidence of RP and LCA will be presented by year and age of onset.
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Thiazide Diuretics and the Risk of Colorectal Cancer: A Population-Based Cohort Study — Samy Suissa ...
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Thiazide Diuretics and the Risk of Colorectal Cancer: A Population-Based Cohort Study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-11
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Emily McDonald - Collaborator - McGill University
Ilan Matok - Collaborator - The Hebrew University of Jerusalem
James Brophy - Collaborator - McGill University
Julie Rouette - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Tibor Schuster - Collaborator - McGill UniversityOutcomes:
We all identify all incident colorectal cancer events occurring during the follow-up period recorded in either the CPRD (identified based on Read codes; see Table A1 in Appendix) or HES repository (based on ICD-10 codes; see Table A2 in Appendix). Diagnoses of colorectal cancer in the CPRD have been previously validated, with a positive predictive value of 98%, sensitivity of 92%, and specificity of 98%, when compared with diagnoses in the UK National Cancer Data Repository. Linkage with HES have resulted in further increases in sensitivity and specificity.
Description: Technical Summary
Antihypertensive drugs are one of the most commonly prescribed drugs worldwide, with thiazide diuretics accounting for nearly 30% of these prescriptions. Recently, there have been controversies regarding the long-term safety of thiazide diuretics. Observational studies have reported associations with certain cancers, including colorectal cancer. To date, however, this possible association has been understudied and warrants further investigation. This is particularly important given that colorectal cancer has the third highest incidence among all cancers. To address this question, we will assemble a cohort of approximately 300,000 patients newly treated with either thiazides or dihydropyridine calcium channel blockers between January 1, 1988 and March 31, 2018, with follow-up until March 31, 2019. Cox proportional hazard models will be used to estimate hazard ratios with 95% confidence intervals of colorectal cancer comparing thiazide diuretics with dihydropyridine calcium channel blockers using standardized morbidity ratio weights. Secondary analyses will assess whether the risk of colorectal cancer varies by duration of use, cumulative dose, and by individual agents. To our knowledge, this will be the first study to specifically assess the association between thiazide diuretics and the incidence of colorectal cancer.
Source - and 7 more projects — click to show
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What happens between first symptoms and first acute exacerbation of COPD? Mapping and prediction study — Alex Bottle ...
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What happens between first symptoms and first acute exacerbation of COPD? Mapping and prediction study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Non-standard
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-17
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Alex Bottle - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Susan Nunn - Collaborator - Imperial College LondonOutcomes:
 Setting where COPD first recorded (primary or secondary care)
 Time from symptom presentation in primary care (where known) to diagnosis
 First acute exacerbation (AECOPD)Description: Technical Summary
Aims and objectives: To describe and model the patient journey from symptom presentation to diagnosis and first acute exacerbation for COPD patients in England. This will include examining variations by Clinical Commissioning Group, GP practice and time period, followed by the construction and validation of a risk prediction or risk trajectory model for the first AECOPD.
Methods: Using the Clinical Practice Research Datalink (CPRD) and two cohorts ten years apart, we will describe the management of the patient following initial presentation with symptoms through to their diagnosis of COPD and their first AECOPD, which for some patients will be the same event. Given that COPD can present differently depending on comorbidity, the mapping will be described separately for people with asthma and heart failure in particular. The second part will model the risk of the first AECOPD using factors such as airways obstruction, age, smoking, BMI, gender, comorbidities and public data on temperature and pollution. This will use logistic regression, random forests and cause-specific hazards modelling. Predictors will be ranked in importance from GP, patient and system perspectives. Models will be externally validated using CPRD ÂAurum practices.
Anticipated impact and dissemination: This study will fill key gaps in our understanding of how patients obtain their COPD diagnosis (their Âroute to diagnosisÂ), how they are managed in primary care, and how they get their first AECOPD. Comparisons between the two time periods will highlight what has changed and inform NHS preparation for future needs regarding COPD. A risk prediction model for first acute exacerbation will aid shared decision-making between GPs and patients and facilitate early intervention; ranking the predictors will suggest priorities for action.
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Potentially unintended discontinuation of medication following hospitalisation: a retrospective cohort study — Patrick Redmond ...
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Potentially unintended discontinuation of medication following hospitalisation: a retrospective cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-11
Organisations:
Patrick Redmond - Chief Investigator - King's College London (KCL)
Patrick Redmond - Corresponding Applicant - King's College London (KCL)
Mariam Molokhia - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Vibhore Prasad - Collaborator - King's College London (KCL)Outcomes:
Failure to renew specified medications (as defined by the absence of the specified medication in the GP prescribing record in the 90 days post hospitalisation/index date)
Description: Technical Summary
Background:
Previous studies have reported an increased risk of medication discontinuity post hospitalisation. These studies have primarily examined large dispensing and/or administrative databases post hospitalisation to record the outcome of 'discontinuity'. There has been limited specialised study of the impact of hospitalisation and/or medication error at hospital discharge propagating forward into general practice prescribing records.Objectives:
To determine whether the unintended discontinuation of specific common, evidence based, long-term medication occurs after hospitalisation; what factors are associated with unintended discontinuation.Design:
A retrospective cohort study utilising Hospital Episodes Statistics and CPRD. A multi-level logistic regression analysis examining the association between discontinuity and hospitalisation comparing those experiencing hospitalisation and those not hospitalised.Primary and secondary outcomes:
Discontinuity of four evidence-based medication drug classes- antithrombotic, lipid-lowering, thyroid replacement drugs and respiratory inhalers in hospitalised versus non-hospitalised patients; patient and health system factors associated with discontinuity.
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An observational, retrospective, matched case-control study to assess the effectiveness of Priorix vaccine in children born after 2004 in the United Kingdom (UK) — Corinne Willame ...
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An observational, retrospective, matched case-control study to assess the effectiveness of Priorix vaccine in children born after 2004 in the United Kingdom (UK)
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-05
Organisations:
Corinne Willame - Chief Investigator - GlaxoSmithKline - UK
Emmanuel ARIS - Corresponding Applicant - GSK
Ana Ramirez Villaescusa - Collaborator - GSK
Brigitte Cheuvart - Collaborator - GSK
Catherine Cohet - Collaborator - Not from an Organisation
Garry Edwards - Collaborator - GSK
Gillian Hall - Collaborator - Gillian Hall Epidemiology Ltd
Marion Montourcy - Collaborator - GSK
Michael Povey - Collaborator - GSK
Nathalie Servotte - Collaborator - GSK
Nayab Malik-Luecken - Collaborator - GSK
Supreeth Srinivasmurthy - Collaborator - GSKOutcomes:
Measles disease and mumps disease reported in primary care and in hospital setting.
Description: Technical Summary
The aim of this study is to assess the effectiveness of Priorix vaccine against measles and mumps diseases in children born after 2004. The vaccine effectiveness (VE) will be evaluated for at least 1 dose (primary objective) and for 1 dose and 2 doses (secondary objectives) of Priorix. VE against measles and mumps diseases will be assessed separately on 2 distinct study populations.
The study will be an observational, retrospective, matched case-control study with a targeted case-control ratio of 1:4. All children born after 2004 and with first diagnosis of measles or mumps disease between January 2006 and December 2018 will be included in the study as cases. Cases will be identified from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases by using disease specific medical codes (CPRD medical codes and International classification of diseases [ICD]-10 codes according to the source data). The index date will be the date of the diagnosis of the first reported event. Control subjects will be matched by month and year of birth and practice region. Exposure to Priorix will be identified by using the batch number variable available in the CPRD database.
A conditional logistic regression will be applied to compute odds ratio. The model will be adjusted for index for multiple deprivation (IMD) and number of consultations during the year prior to index date as covariates. VE will be calculated using the following formula:
VE=1- (odds of exposure in case group/odds of exposure in control group).
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Pelvic inflammatory disease, associated infections, and risk for ovarian cancer in the United Kingdom Clinical Practice Research Datalink — Britton Trabert ...
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Pelvic inflammatory disease, associated infections, and risk for ovarian cancer in the United Kingdom Clinical Practice Research Datalink
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-17
Organisations:
Britton Trabert - Chief Investigator - National Cancer Institute ( NCI )
Kara Michels - Corresponding Applicant - National Cancer Institute ( NCI )
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Hamish Mohammed - Collaborator - Public Health England
Kate Soldan - Collaborator - Health Protection Agency - HPA
Megan Clarke - Collaborator - National Cancer Institute ( NCI )Outcomes:
Primary outcome: ovarian and fallopian tube cancers, some peritoneal cancers
- Secondary outcome: endometrial cancer
- Secondary outcome: breast cancerDescription: Technical Summary
Infections and chronic inflammation that affect the fallopian tubes are being investigated as possible ovarian cancer initiators/promoters, as the majority of serous ovarian cancers are thought to originate in the fallopian tubes. Several studies examine risk for ovarian cancer associated with pelvic inflammatory disease (PID), but do not have information on PID-associated infections, do not include fallopian tube cancers, and often rely on patient report. The United Kingdom Clinical Practice Research Datalink (CPRD) is an ideal population to prospectively examine the associations between medical record confirmed PID, several of its underlying causes, and ovarian cancer. We plan to generate an exposure-matched cohort of women with a record of PID, chlamydia infection, and/or gonorrhoea infection diagnosed in English CPRD clinics. We will link to death registration data and the National Cancer Registration and Analysis Service to identify incident, invasive ovarian, fallopian tube, and peritoneal cancers for our primary outcome and for censoring information (death certificate-confirmed cancers will be included). Cox proportional hazards models will be used to estimate time to diagnosis of these cancers associated with record of PID and its related infections. We will also estimate cancer risks by histologic subtype and stage.
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The effect of common infections on the risk of dementia in individuals with and without diabetes: a cohort study using UK primary and secondary care data — Charlotte Warren...
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The effect of common infections on the risk of dementia in individuals with and without diabetes: a cohort study using UK primary and secondary care data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-24
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rutendo Muzambi - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Carol Brayne - Collaborator - University of Cambridge
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nishi Chaturvedi - Collaborator - University College London ( UCL )Outcomes:
Primary Outcomes:
(1) Incidence of dementia (all types)
(2) Incident dementia (type-specific AlzheimerÂs disease, vascular, mixed, other).Secondary Outcome
(1) Evidence of cognitive impairmentDescription: Technical Summary
Dementia poses a significant burden on disability and dependence worldwide. Due to the increasing ageing population and absence of pharmacological therapies that can delay the onset or progression of dementia, dementia risk reduction has become a public health priority. Recent evidence suggests that the incidence of dementia is declining in Europe and the USA, and this change has been partly attributed to modifiable risk factors. Common infections have been identified as potential risk factors for dementia. In turn, common infections are more prevalent in diabetes, which is a strong risk factor for dementia. We hypothesise that individuals diagnosed with common infections (lower respiratory tract, urinary tract, skin and soft tissue infections and sepsis) will have an increased risk of dementia, and that this risk will increase in individuals with diabetes compared to those without diabetes.
To test this hypothesis, we will carry out a cohort study of older adults aged 65 years and over using prospectively collected CPRD data linked to hospital episode statistics. We will exclude individuals with prevalent dementia and cognitive impairment at baseline. We will assess the age-specific incidence rates of dementia in individuals with and without common infections. Then, we will use Cox regression models to investigate the effect of the type, timing and frequency of infections on the incidence of dementia, adjusting for confounding factors. We will then investigate the presence of effect modification by diabetes on the association between common infections and incident dementia. Finally, we will investigate whether there is an association between common infections and evidence of cognitive impairment. To the test the robustness of our findings, we will carry out a range of sensitivity analyses. Improved understanding of the interrelationship between infections and diabetes with incident dementia will help to inform dementia risk reduction interventions.
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Trends in Acid Suppressant Drug Prescriptions in Primary Care in the United Kingdom — Samy Suissa ...
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Trends in Acid Suppressant Drug Prescriptions in Primary Care in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-27
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Devin Abrahami - Collaborator - McGill University
Emily McDonald - Collaborator - McGill University
Mireille Schnitzer - Collaborator - University Of MontrealOutcomes:
The outcomes of interest for this study are rates of proton pump inhibitor (PPI) and histamine-2 receptor antagonist (H2RA) prescriptions over time. Prescriptions for both drug classes will be identified using BNF codes, listed in Appendices I & II.
Description: Technical Summary
Proton pump inhibitors and histaimine-2 receptor antagonists are acid suppressant drugs used by millions of individuals across the United Kingdom to manage the symptoms of several gastric diseases. In recent years, the use of PPIs has been steadily increasing, with over 50 million PPI prescriptions dispensed in 2015 in England alone. As a result of this dramatic increase, and given the risks associated with PPI use, the National Institute for Clinical Evidence recommended deprescribing PPIs in primary care as of 2014. Deprescribing can be described as dose de-escalation, or yearly treatment reassessment. However, there is little evidence on the effectiveness of this recommendation, and whether or not this has influenced prescribing practices of general practitioners. It is also unknown whether the over the counter availability of proton pump inhibitors has influenced their prescribing rates among general practitioners. Thus, we will conduct a drug utilization study to examine the existing gaps in knowledge in the utilization of acid suppressant drugs in the United Kingdom. Specifically, we will examine yearly prescribing incidence rates for both classes of acid suppressant drugs and examine patterns of use among certain subgroups (stratified by age, sex, indication and country). We will also examine persistence patterns to determine the impact of the latest deprescribing guidelines published by the National Institute for Clinical Evidence. Finally, we will conduct an interrupted time series analysis to determine whether the over the counter availability has influenced prescribing rates of general practitioners. Overall, this study will examine how acid suppressant drugs are being used in clinical practice and may help determine if new deprescribing initiatives are necessary.
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The cumulative incidence of seizures during 21 days after new use of oral antibiotics in patients with epilepsy - a cohort study — Susan Jick ...
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The cumulative incidence of seizures during 21 days after new use of oral antibiotics in patients with epilepsy - a cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-06-17
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Marlene Rauch - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Lea Barone - Collaborator - University Hospital Basel
Raoul Sutter - Collaborator - University Hospital Basel
Sarah Tschudin Sutter - Collaborator - University Hospital Basel
Stephan Ruegg - Collaborator - University of BaselOutcomes:
Epileptic seizures as recorded using Read codes in CPRD GOLD data, and in a sensitivity analysis, as recorded using ICD-10 codes in HES APC data.
Description: Technical Summary
We will estimate the cumulative incidence of epileptic seizures in patients with epilepsy aged 16 years or older during the 21-day period after recording of a new oral antibiotic prescription (beta-lactam antibiotics, quinolones, macrolides/lincosamides, tetracyclines, or sulfonamides/ trimethoprim) in the patient record. We will assess the cumulative incidence of epileptic seizures in a matched comparison group of patients with epilepsy not prescribed antibiotics at that time. We will divide the study period (January 1, 1997 and December 31, 2018) into twenty-two 1-year study blocks, and each patient who was exposed in a block will be matched 1:1 to a patient who was unexposed within the same block on general practice, age, sex, calendar time, and recorded history on the database. We will estimate cumulative incidences of epileptic seizures stratified by age, estimated glomerular filtration rate, additional risk factors for epileptic seizures apart from epilepsy (drug or alcohol dependence, metabolic disturbances, brain disorders), underlying infection type, prescribed antibiotic type, and a proxy for severity of epilepsy (number of prescribed anticonvulsants, number of seizures in the year prior to the antibiotic prescription or the comparison date of the comparison group). We will also calculate risk ratios of epileptic seizures by dividing the cumulative incidence in exposed patients by the cumulative incidence in the matched non-exposed comparison group.
In a sensitivity analysis among CPRD patients linked to HES APC, we will repeat the main analysis (estimation of cumulative incidence of epileptic seizures in exposed and unexposed patients, calculation of risk ratio of epileptic seizures in exposed vs. unexposed patients) applying a stricter definition of the outcome, namely a hospitalisation with a recorded ICD-10 code of epileptic seizures as the primary reason for hospital admission in HES APC data.
Source
2019 - 05
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Assessment of Long-Term Bowel Dysfunction in Rectal Cancer Survivors  A Population-Based Cohort Study — Samy Suissa ...
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Assessment of Long-Term Bowel Dysfunction in Rectal Cancer Survivors  A Population-Based Cohort Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-21
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Jeongyoon Moon - Collaborator - McGill University
Marylise Boutros - Collaborator - McGill University
Paul Brassard - Collaborator - McGill University
Richard Garfinkle - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The following outcomes will be measured in this cohort: (1) bowel dysfunction; (2) sexual symptoms; (3) urinary symptoms; (4) and stoma non-closure. Each of these outcomes will be operationally defined using read-codes for relevant symptoms recorded in CPRD GOLD (see section N below).
Description: Technical Summary
The most common operation performed for rectal cancer is a restorative proctectomy. While this operation avoids a permanent ostomy, many patients (~70%) are left with significant bowel dysfunction (e.g., frequency, urgency, and incontinence) that impairs their quality of life. Furthermore, patients may experience urinary and sexual dysfunction, both of which can be consequences of pelvic surgery and radiotherapy. The primary objective of this study is to estimate the incidence of bowel dysfunction after rectal cancer surgery, and to identify factors associated with its development. Secondary objectives are to estimate the incidence of postoperative sexual and urinary symptoms, as well as to evaluate the association between bowel dysfunction and new-onset postoperative sexual and urinary symptoms. This will be a large cohort study making use of two linked databases. Cohort inclusion criteria will be based on relevant rectal surgery procedures codes in the HES database, and outcomes will be defined using symptom read-codes and medication prescription product-codes recorded in CPRD. The cohort will be described using demographic, patient, and disease characteristics. The principal exposures of interest will include treatment (the use of preoperative radiotherapy, the use of postoperative chemotherapy), operative (operative approach, tumor height, use of a diverting ostomy), and postoperative (anastomotic leak) characteristics. A Cox proportional hazards model will be used to adjust for potential confounders.
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An observational study to establish the cardiovascular-renal-metabolism comorbidity epidemiology and healthcare utilisation in England — Jil Billy Mamza ...
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An observational study to establish the cardiovascular-renal-metabolism comorbidity epidemiology and healthcare utilisation in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-30
Organisations:
Jil Billy Mamza - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Jil Billy Mamza - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Amitava Banerjee - Collaborator - University College London ( UCL )
Betina Blak - Collaborator - Astra Zeneca Ltd - UK Headquarters
Folkert Asselbergs - Collaborator - University College London ( UCL )
George Godfrey - Collaborator - Astra Zeneca Ltd - UK Headquarters
Harry Hemingway - Collaborator - University College London ( UCL )
Johan Bodegård - Collaborator - Astra Zeneca Inc - USA
Mike Ford - Collaborator - Astra Zeneca Ltd - UK Headquarters
Rob Hastings - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ruiqi Zhang - Collaborator - Astra Zeneca Ltd - UK Headquarters
Spiros Denaxas - Collaborator - University College London ( UCL )
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK Headquarters
Una Rigney - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
The study outcomes are aligned to the core objectives of this study and described in two work packages (WP).
WP1  Development of cardiorenal events in Âcardiorenal disease-free T2D patients
Primary outcomes include first hospitalisations for heart failure (HF) chronic kidney disease (CKD) peripheral artery disease (PAD), myocardial infarction (MI) and Stroke (cardiorenal events) in Âcardiorenal diseases-free T2D population.
Secondary outcomes include manifestations of cardiorenal events, CV mortality and all-cause mortality following hospitalisation for specified diseases; associated risk factors.WP2 Â Healthcare resource utilisation (HRU)
Supplementary outcomes include proportions of T2D patients with unique combinations of cardiorenal events, health care resource use and monetised costs of resource use; resources include disease management services in the clinical guideline, e.g., GP consultations, laboratory tests or measurements, medications, hospitalisations, etc.Description: Technical Summary
It is increasingly being recognised there are commonalities between cardiovascular, renal and metabolic (CaReMe) diseases with clinical overlap between these diseases and their associated complications.1, 2 Although these relationships between disorders are increasingly being elucidated there is often under-recognition by health care professionals and patients and this contributes to patients being managed for conditions in isolation.3 These relationships are increasingly important as therapies develop that could address multiple aspects of disease outcomes and may be used across this spectrum of disorders. Using a cohort of prevalent T2D patients, we will examine the incidence of cardiorenal diseases, their patterns of appearance over time, and subsequent association with adverse clinical outcomes such as cardiovascular (CV) and all-cause mortality. This study will utilise the CPRD Aurum database and the study period will begin on 1 April 2007 and will end on 31 March 2019. Each of the clinical outcomes of interest will be described separately. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Survival distributions utilising Kaplan-Meir method will describe time to cardiorenal disease progression, time to CV- and all-cause mortality. Relative risks and risk factors associated with outcomes will be estimated using Cox proportional hazard models. In addition, we aim to further highlight the impact of comorbidities on health care resource utilisation. Using a cohort of incident T2D patients, we will examine the care pathways of the patients to describe health resource use including GP consultations, laboratory tests or measurements, medication, referrals to specialist and hospital admissions. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
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Classification and prediction of missing ethnicity in diabetic patients from electronic health record data — Luigi Palla ...
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Classification and prediction of missing ethnicity in diabetic patients from electronic health record data
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-20
Organisations:
Luigi Palla - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Luigi Palla - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Samantha Kwong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Ethnicity
Description: Technical Summary
The aim of this project is to investigate how to characterise patients of different ethnic groups, including unknown ethnicity using multivariate statistical methods like principal component and cluster analyses on different sets of baseline variables such as biomarkers, demographics, comorbidities, separately and combined Such multivariate techniques will allow us to explore whether and which set of variables allows us to identify groupings corresponding to the different ethnic groups. Subsequently discriminant analyses techniques will be applied depending on the results of the clustering, with the aim of predicting ethnicity/missing ethnicity. Such techniques can be parametric (e.g. linear discriminant analysis, logistic regression) and non-parametric (e.g. classification trees, random forests). Considerations about the assumptions required and interpretative issues will lead us to use either type of techniques and/or compare the performances of different prediction techniques. Which variables contribute to the classification of missing vs non-missing will also be an important question we will be addressing by these multivariate techniques.
The impact of using general practice level information as a proxy for patient level information (for example using the deprivation score of the general practice postcode instead of the patient's home postcode), will also be assessed when using such variables for clustering and classification.
This work will help us assess how to deal with missing ethnicity and will inform decisions about the use of imputation methods for unknown ethnic group in future causal analyses on the effect of ethnicity in particular and provide an insight on the impact of coarser measurement of the exposure.
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Concomitant use of oral glucocorticoids and proton pump inhibitors, and risk of osteoporotic fractures among patients with rheumatoid arthritis: a population-based cohort study — Frank de Vries ...
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Concomitant use of oral glucocorticoids and proton pump inhibitors, and risk of osteoporotic fractures among patients with rheumatoid arthritis: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-07
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Anna Elise (Annelies) Boonen - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Patrick Souverein - Collaborator - Utrecht University
Shahab Abtahi - Collaborator - Utrecht University
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Occurrence of an osteoporotic fracture, including hip/femur, clinical symptomatic vertebral, humerus, forearm, pelvic, and rib fractures.
Description: Technical Summary
Objectives: To investigate the association between concomitant use of glucocorticoids (GCs) and proton pump inhibitors (PPIs), and the risk of fracture among patients with rheumatoid arthritis (RA).
Design: Retrospective cohort study using the Clinical Practice Research Datalink (CPRD).
Participants: All adults aged 50 years and older diagnosed with RA in CPRD between 1997 and 2017. The Âindex date will be the RA diagnosis, recorded as the first read code for RA during valid data collection.
Primary exposure: There will be two primary exposures of interest in this study. First, the use of oral GCs, and secondly, the use of PPIs. Exposure to treatment will be assessed time-dependently, and in 30-day follow-up periods.
Outcome: The outcome in our study is occurrence of the first incident osteoporotic (OP) fracture in RA patients after the index date, which include hip/femur, clinical symptomatic vertebral, humerus, forearm, pelvic, and rib fractures.
Statistical analyses: Cox proportional-hazards models will be used to conduct the statistical analysis. The first and main analysis will compare the OP fracture risk between RA patients who are current users of both GCs and PPIs, and RA patients who take neither of them. Separate analyses will be conducted for various OP fracture sites. Also, the only use of either of these medications, i.e. GCs, or PPIs, will be compared to the control group, in order to estimate the fracture risk of any of these drugs, individually. Furthermore, recent and past use of either of these drugs will be compared to non-use. The secondary analysis will focus on average daily and cumulative dose of current GC and average daily dose and duration of current PPI use in RA patients and will be compared to non-use of both drugs. All calculations will be adjusted for the potential confounders.
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Incidence of opportunistic infections in patients diagnosed with inflammatory bowel disease: a population-based cohort study — Sally Lee ...
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Incidence of opportunistic infections in patients diagnosed with inflammatory bowel disease: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-21
Organisations:
Sally Lee - Chief Investigator - Celgene Ltd
Sally Lee - Corresponding Applicant - Celgene Ltd
Ran Gao - Collaborator - Boehringer-Ingelheim International GmbH
Steve Niemcryk - Collaborator - Celgene Ltd
Tongsheng Wang - Collaborator - Celgene LtdOutcomes:
Study outcome events will be opportunistic infections occurring during the follow-up period. Opportunistic infections will be categorized as the following types:
 Viral: CMV, EBV, HSV, varicella zoster, HBV, HCV
 Fungal: histoplasmosis, candidiasis, and blastomycosis
 Bacterial: tuberculosis and streptococcal
We will define a new infection as a diagnosis code for infection when no prior infection code of the same type is observed within at least the previous 6 months. Tuberculosis, HBV, and HCV are chronic infections; thus, patients with a prior diagnosis of HBV, HCV, and Tuberculosis at any time prior to a diagnosis of IBD will be excluded from these analyses. Only the first diagnosis of these infections after the diagnosis of IBD will be counted. The incidence rate of each specific opportunistic infection will be estimated and stratified by age category, gender, year of cohort entry and different comorbidity status (HIV, malignancy, CVD, depression, hypertension, diabetes, fractures/osteoporosis and autoimmune diseases).Description: Technical Summary
This is a hypothesis generating retrospective cohort study to estimate the incidence rates of opportunistic infections in patients diagnosed with IBD, stratified by type of opportunistic infections, age group, gender, year of cohort entry and pre-existing of comorbid conditions. UC or CD or indeterminate IBD patients with at least one year of history/registration in CPRD will be included and followed from their initial diagnosis of UC or CD or indeterminate IBD to censor in the data, the censor date is the earliest of the following: 1) The occurrence of an opportunistic infection (separately for each event), 2) Loss of eligibility, 3) Death, 4) End of data collection. We will use ByarÂs method or exact method to estimate IR and IRR between strata with 95% confidence intervals (CIs) for each type of opportunistic infection. We will provide cumulative incidence functions of the first infection for each study outcome at various time of follow-up using the Kaplan Meier method. Proportions will be compared using a chi-square test or, where cell sizes are less than 5, a FisherÂs exact test. Kaplan Meier curves will be compared using a log rank test. Statistical analyses will be carried out using SAS Release 9.4 (SAS Institute Inc., Cary NC, USA).
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The Impact of Varying the Inception Cohort on the Performance of Risk Prediction Models for Time-to-Event Analyses — Samy Suissa ...
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The Impact of Varying the Inception Cohort on the Performance of Risk Prediction Models for Time-to-Event Analyses
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-28
Organisations:
Samy Suissa - Chief Investigator - McGill University
Robert Platt - Corresponding Applicant - McGill University
Graeme Smith - Collaborator - Queen's University Belfast
Jennifer Hutcheon - Collaborator - University Of British Columbia
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sonia Grandi - Collaborator - McGill UniversityOutcomes:
Primary outcome: The primary outcome of incident CVD will be defined as, cerebrovascular disease, coronary artery disease, coronary revascularization, myocardial infarction, peripheral vascular disease, transient ischemic attack, unstable angina, or stroke
Description: Technical Summary
Although previous studies have shown an association between hypertensive disorders of pregnancy (HDP) and later CVD, the tools currently used by clinicians to predict a womenÂs long-term risk of CVD do not account for complications in pregnancy such as HDP. Given the increasing rates of HDP and the limitations of previous risk prediction tools, there is a need to develop risk prediction models accounting for complications of pregnancy. However, the choice of inception cohort may impact the accuracy and performance of prediction models and also impact the generalizability of the models since women can contribute more than one pregnancy during the follow-up period. We will perform a plasmode simulation using the CPRD Pregnancy Register linked to Hospital Episode Statistics (HES) in order to determine how the inclusion of one versus multiple pregnancies per woman influences the accuracy and performance of risk prediction models. We will construct four cohorts based on a first delivery per women, a random sample of pregnancies, or all eligible pregnancies per women during the study period. Risk prediction models will be developed in each of these cohorts using women between the ages of 15-45 with a recorded delivery from April 1st, 2000 to March 31st, 2017. Deliveries will be identified from the Pregnancy Registry. The date of cohort entry will be defined as 42 days after the delivery date. Women will be followed until an event (incident cardiovascular disease) or censoring due to end of CPRD registration, last data collection, or end of the study period, whichever occurs first. Prediction models will be developed using an accelerated failure time models with time since cohort entry as the time axis. The accuracy and performance of models developed in each cohort will be compared.
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Development and internal validation of prognostic scores for risk of diabetic foot ulceration — Frank de Vries ...
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Development and internal validation of prognostic scores for risk of diabetic foot ulceration
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-08
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Johan Roikjer - Collaborator - Aalborg University Hospital
Johanna Driessen - Collaborator - Utrecht University
Johannes T.H. Nielen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Nicolaas Schaper - Collaborator - Maastricht University
Niels Ejskjaer - Collaborator - Aalborg University Hospital
Romin Pajouheshnia - Collaborator - Utrecht UniversityOutcomes:
Diabetic foot ulceration (composite, and stratified by aetiology) Â Appendix 2-5
Description: Technical Summary
The study objective is to develop prognostic scores for risk of diabetic foot ulceration (DFU), broken down by aetiology (composite, ischaemic, neuropathic, infected), in patients with a diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Patients aged 18 years or older with a registration of T1DM or T2DM between April 2004 and time of data extraction (approximately March 2019) will be included. The date of first diagnosis will define start of follow-up. All patients will be followed up for the occurrence of DFU (composite and aetiology specific), date of transfer out of practice area, death, end of data collection, or end of risk period (1, 5, 10, or 15 years), whichever will come first.
Both traditional epidemiological methods and machine learning techniques will be applied to develop and validate the prognostic scores.
Traditional: Regression models will be fitted with a predefined set of determinants for DFU, using forward selection with a significance level of 0.05. Various measures for prognostic accuracy including sensitivity, specificity, positive predictive values, negative predictive values, and beta-coefficients of the included factors will be determined. The beta-coefficients in the final Cox models will be converted into 1-, 5-, 10-, and 15-year absolute risk scores. The models performance will be determined by assessing goodness-of-fit and by assessment of the discriminative ability. To asses internal validity a k-fold cross-validation will be conducted.
Machine learning: The study population will be split into a `training' cohort and a Âtest cohort. The training cohort will be used to develop the prediction models using machine learning algorithms such as random forest (RF) and artificial neural networks (ANN). The models will be trained through 10-fold cross-validation. The test dataset will be used for model evaluation. Accuracy, sensitivity, specificity, receiver operating characteristics (ROC) curves and areas under the curve (AUC) will be determined.
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Developing and validating an optimised tool to identify familial hypercholesterolaemia in routine primary care (FAMCAT 2) — Ralph Kwame Akyea ...
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Developing and validating an optimised tool to identify familial hypercholesterolaemia in routine primary care (FAMCAT 2)
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-22
Organisations:
Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of NottinghamOutcomes:
First (incident) diagnosis of familial hypercholesterolaemia.
Description: Technical Summary
Background: The algorithm for the tool to identify familial hypercholesterolaemia (FH) in routine primary care (FAMCAT) was developed and published in February 2015. Since then, the algorithm has been validated using UK primary care databases such as QResearch and RCGP database, and has shown to have consistently high performance. Based on recently available evidence, we seek to update and recalibrate the FAMCAT algorithm to the latest version of the Clinical Practice Research Datalink (CPRD) database. This will help to ensure the tool/algorithm reflects the changes in population characteristics and improvements in data quality which increases the ascertainment of FH events.
Aim: To develop and validate an updated version of the FAMCAT case identifying tool for familial hypercholesterolaemia in routine primary care.
Design: Retrospective open cohort study
Setting: General practices in UK providing data to the CPRD database.
Participants: All patients with at least 1 measurement of either total or LDL cholesterol between the baseline date (1 Jan 1999) and study end date (latest update of CPRD).
Outcomes: First (incident) diagnosis of familial hypercholesterolaemia.
Methods: The study population will be randomly split into algorithm derivation (70%) and validation (30%) cohorts. Random forest model will be developed to explore the composition and individual strength of novel risk factors/signals, with the current FAMCAT algorithm as the baseline. Logistic regression model will be used to estimate the coefficients and odds ratios associated with each potential risk factor for the diagnosis of FH for men and women separately. Prediction accuracy will be assessed by area under the receiver operating curve, sensitivity, specificity, positive predictive value and negative predictive value at various thresholds for diagnosis.
Outputs: An updated case case-finding tool to identify FH in routine primary care (FAMCAT2).
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SGLT-2 inhibitors and the risk of venous thromboembolism — Samy Suissa ...
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SGLT-2 inhibitors and the risk of venous thromboembolism
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-02
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Stephanie Aloe - Collaborator - McGill University
Vicky Tagalakis - Collaborator - McGill UniversityOutcomes:
Venous thromboembolism, including deep venous thrombosis and/or pulmonary embolism
Description: Technical Summary
Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are a novel class of anti-diabetic drugs that entered the market in 2013. The main mechanism of action of this class of drugs is the inhibition of the SGLT-2 in the kidneyÂs proximal convoluted tubule, resulting in increased urine glucose excretion. This induced osmotic diuresis can cause dehydration and subsequent hemoconcentration, which has been associated with an increased risk of venous thromboembolism (VTE). For this reason, VTE events were monitored in SGLT-2 inhibitor trials. The rates of VTE were comparable between SGLT-2 users and control groups. Nonetheless, the FDA has released a warning of a potential risk for stroke and thromboembolic events with SGLT-2 inhibitors. A recent cohort study evaluated the risk of seven adverse events with SGLT-2 inhibitor use and did not find an increased risk of VTE. However, the analyses may have been underpowered since the number of events was low. Thus, given the morbidity and mortality associated with VTE, it is important to further assess this potential adverse drug reaction in sufficiently-powered studies.
This retrospective cohort study will examine the risk of VTE with the use of SGLT-2 inhibitors using the United KingdomÂs (UK) Clinical Practice Research Datalink (CPRD) linked to hospitalization and vital statistics data. The primary endpoint will be VTE, defined by either hospitalization for VTE, an outpatient diagnosis of VTE accompanied by a prescription for an anticoagulant or international normalized ratio (INR) testing (suggesting anticoagulation with warfarin), or death with a recorded diagnosis of VTE as a contributing cause of death. We will use time-dependent Cox proportional hazards models to compare event rates with the use of SGLT-2 inhibitors to those with the use of dipeptidyl peptidase-4 (DPP-4) inhibitors. Secondary analyses will examine if the risks differ by molecule, duration of use, sex, age, or prior history of VTE.
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Anticholinergic antidepressant drugs and long-term risk of dementia — Andrew Mosholder ...
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Anticholinergic antidepressant drugs and long-term risk of dementia
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-28
Organisations:
Andrew Mosholder - Chief Investigator - Food and Drug Administration - FDA
Andrew Mosholder - Corresponding Applicant - Food and Drug Administration - FDA
Benedict Wong - Collaborator - Food and Drug Administration - FDA
Catherine Callahan - Collaborator - Food and Drug Administration - FDA
David Graham - Collaborator - Food and Drug Administration - FDA
Kira Leishear White - Collaborator - Food and Drug Administration - FDA
Marie Bradley - Collaborator - Food and Drug Administration - FDA
Yuegin Zhao - Collaborator - Food and Drug Administration - FDAOutcomes:
 AlzheimerÂs disease
 Vascular dementia
 All-cause mortalityDescription: Technical Summary
Anticholinergic drugs induce cognitive impairments, and accordingly their use has been discouraged in older patients. Beyond these acute effects, some observational studies have pointed to an association between chronic anticholinergic drug exposure and an increased risk of developing dementia. However, as the comparison groups for these studies have generally been non-users of anticholinergic drugs, confounding by indication remains a possible explanation for these associations. Accordingly, we will undertake a study to compare the risk of dementia with exposure to anticholinergic drugs for depression (amitriptyline and paroxetine) in comparison with drugs for depression that are not anticholinergic (fluoxetine and sertraline). We will conduct a time-to-event analysis for the outcome of a diagnosis of dementia with a Cox proportional hazards model, analysing cumulative duration of drug exposure as a time-varying covariate, and using propensity score methods to adjust for potential confounders.
Source - and 18 more projects — click to show
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Using routinely collected healthcare data to predict onset of AF and determine subsequent disease trajectories — Jianhua Wu ...
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Using routinely collected healthcare data to predict onset of AF and determine subsequent disease trajectories
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-28
Organisations:
Jianhua Wu - Chief Investigator - University of Leeds
Jianhua Wu - Corresponding Applicant - University of Leeds
Campbell Cowan - Collaborator - Leeds Teaching Hospitals NHS Trust
Chris Gale - Collaborator - University of Leeds
Marlous Hall - Collaborator - University of Leeds
Tatendashe Dondo - Collaborator - University of LeedsOutcomes:
Cardiovascular and non-cardiovascular related hospital admission, atrial fibrillation, mortality
Description: Technical Summary
Atrial fibrillation (AF) is a major cardiovascular health problem: it is common, chronic and incurs substantial health-care expenditure as a result of stroke, sudden death, heart failure and unplanned hospitalisation.
Yet, many patients with AF are diagnosed too late  for example, when stroke has occurred. Moreover, there is very little information about the prediction of for whom and when new onset AF will occur  a fundamental knowledge gap which if filled could transform the outcomes of patients with AF. Equally, little is known about the full extent of the health burden of AF  beyond that of hypothesis-driven clinical outcomes, such as stroke, myocardial infarction and health failure. In addition, oral anticoagulation is often prescribed to patients with AF to reduce the risk of stroke prevention; however, their uptake is limited.
In essence, there are no largescale population-based studies which provide high-resolution insights into the healthcare burden, treatment and disease trajectories of patients with AF.
Therefore, this study aims to investigate the healthcare burden and clinical pathways of patients with AF using national hospital linked electronic primary healthcare databases.
Specifically, the study will:
1. Quantify the incidence of cardiovascular and non-cardiovascular outcomes and mortality, and project the disease pathways amongst AF patients compared with the general population.
2. Investigate the use of oral anticoagulants among patients with AF and quantify their association with major cardiovascular and non-cardiovascular outcomes.
3. Determine predictors of new onset of AF.Quantifying the population trends and clinical pathways of AF patients, its management with the uptake of oral anticoagulants and subsequent healthcare burden will help target therapeutic strategies to specific groups of patients to further reduce the incidence of stroke and premature mortality. In addition, determining the predictive factors for new onset AF also help targeting the high-risk individuals for preventive measures.
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Distribution of risk of cardiovascular diseases and fractures among elderly women with a recent fracture in CPRD: a cross-sectional study — Alireza Moayyeri ...
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Distribution of risk of cardiovascular diseases and fractures among elderly women with a recent fracture in CPRD: a cross-sectional study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-19
Organisations:
Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Alireza Moayyeri - Corresponding Applicant - UCB Pharma SA - UK
Emese Toth - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Victor Kiri - Collaborator - UCB BioSciences, Inc.Outcomes:
Predicted risk of cardiovascular diseases and osteoporotic fractures, using two established clinical risk prediction tools, in a large population of patients with incident fractures.
Description: Technical Summary
STUDY OBJECTIVE: To explore and visualise the distribution of risk of cardiovascular diseases and osteoporotic fractures in a female post-fracture population.
METHODS/DESIGN: This will be a cross-sectional study. Women registered in CPRD for at least 12 months during the study period will be included if they have an incident fracture while they are aged 50 years or more. Two established clinical risk prediction tools (QRisk for cardiovascular diseases and QFracture for osteoporotic fractures) will be applied at the date of the incident fracture to all patients based on the demographic and clinical data in the 12-month period before fracture date. Risk distribution for diseases in total population and various sub-populations will be presented visually for exploration.
IMPORTANCE: The results of the study will help in hypothesis generation regarding the potential risk relationships between cardiovascular diseases and osteoporotic fractures. Given the potential hazardous effects of some anti-osteoporotic treatments on cardiovascular diseases, identification of patients at high risk of fracture but low risk of cardiovascular diseases is important for targeting with new medications.
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Determinants of blood pressure lowering treatment prescribing for primary prevention: a cohort study in UK primary care — Emily Herrett ...
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Determinants of blood pressure lowering treatment prescribing for primary prevention: a cohort study in UK primary care
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-07
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Adam Timmis - Collaborator - Queen Mary University of London
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Reecha Sofat - Collaborator - University College London ( UCL )
Rod Jackson - Collaborator - University of Auckland
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Objectives 1-3: Prescription of blood pressure treatment on date of hypertension diagnosisObjective 4: Control of blood pressure
Description: Technical Summary
Randomised trials have shown that blood pressure lowering treatment reduces the risk of cardiovascular disease. For primary prevention, the National Institute of Health and Care Excellence (NICE) recommends using a combination of blood pressure and risk to determine eligibility for blood pressure lowering treatment. However, there is some evidence that GPs and patients do not understand, agree with, or use measures of absolute risk in their decision making, and continue to use 'hypertension' alone as an indication for treatment, irrespective of their risk. We have previously shown that an entirely risk-based approach to blood pressure lowering would be at least as efficient and would prevent more cardiovascular disease events than the current and newly proposed NICE guidance. However, if an entirely risk-based strategy is to be implemented, then it will rely on GPs using risk in their decision making for treatment.
Therefore, this study aims to investigate current patterns of prescribing of blood pressure lowering treatment among patients with incident hypertension, and which patient-level factors are most strongly related to incident prescription of blood pressure lowering treatment. Furthermore, given the increasing importance of blood pressure control among patients with increasing cardiovascular disease risk, we will determine which patient-level factors are most strongly related to subsequent control of blood pressure.
We will conduct a cohort study in CPRD, identifying patients with incident hypertension between 2013 and 2017. The outcome will be a new prescription of blood pressure lowering drugs on the date of diagnosis. We will describe drug use by QRISK2 scores, systolic and diastolic blood pressure, and other patient-level characteristics including age, sex, diabetes, polypharmacy, and comorbidity. We will use logistic regression modelling to investigate the determinants of prescribing, and the determinants of control at six months and one year.
The results of this study will guide future recommendations and help to provide support for GPs to translate any new guidelines into clinical practice.
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Temporal trends in the incidence of autism spectrum disorder in children and variation in diagnosis rates: A retrospective study using UK electronic medical records — Amit Kiran ...
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Temporal trends in the incidence of autism spectrum disorder in children and variation in diagnosis rates: A retrospective study using UK electronic medical records
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-30
Organisations:
Amit Kiran - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Amit Kiran - Corresponding Applicant - Astellas Pharma Europe Ltd. - UKOutcomes:
The primary outcome is diagnosis of ASD. ASD diagnosis will be identified as any record of autism, AspergerÂs syndrome or pervasive developmental disorder, using an apriori list of Readcodes. A patients earliest record of ASD will be their incident diagnosis.
As defined The list of ASD Readcodes have been previously validated and published by Hagberg et al (2017).,ASD will be a composite binary outcome of Autism, AspergerÂs syndrome and Pervasive developmental disorder. The following codes will be used,
readcode meddesc
Autism
E140.00 Infantile autism
E140000 Active infantile autism
E140100 Residual infantile autism
E140.12 Autism
E140.13 Childhood autism
E140z00 Infantile autism NOS
Eu84000 [X]Childhood autism
Eu84012 [X]Infantile autism
Eu84100 [X]Atypical autism
Eu84z11 [X]Autistic spectrum disorder
Eu84011 [X]Autistic disorder
AspergerÂs syndrome
Eu84500 [X]Asperger's syndrome
Pervasive developmental disorder
Eu84.00 [X]Pervasive developmental disorders
Eu84y00 [X]Other pervasive developmental disorders
Eu84z00 [X]Pervasive developmental disorder, unspecifiedDescription: Technical Summary
There is a paucity of published evidence on the incidence of ASD in children in the UK. Reliable evidence is needed to help provide insight for service planning and provisions.
This study aims to describe the incidence of ASD in children aged 1 to 18 years, and the determinants of variation in diagnosis rates among GP clinics. The study will be an exploratory retrospective cohort study using the most recent 15 years of linked electronic medical records from the UK.
ASD diagnosis will be identified as any record of autism, AspergerÂs syndrome or pervasive developmental disorder using an apriori list of Readcodes that have previously been validated and published by Hagberg et al (2017). A patients earliest record of ASD will be their incident diagnosis.
For the primary analysis, annual incidence rates of ASD will be reported to observe if there have been changes in recent years. The incidence at each calendar year will also be stratified by age groups. Incidence rates of ASD by GP site will be analysed to report on variation (after adjusting for patient characteristics).
Key determinants of variation in rates among GP clinics, such as ethnicity and SES, will also be reported to provide insight on potential equitable or inequitable access to services.
In a secondary analysis, we will repeat the primary analysis but this time using autism Readcodes only as the outcome (not using AspergerÂs syndrome and pervasive developmental disorder).
In sensitivity analyses, we will review patients with discrepant ethnicity data who have initially been classified in one ethnic group, and will move them to their other ethnic group, and repeat the primary analysis. We will also repeat the main analysis (which will use Gold and Aurum combined) but this time analysing Gold and Aurum separately.
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Non-steroidal anti-inflammatory drug use and the risk of revision of lower joint replacement: A retrospective cohort study — Olaf Klungel ...
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Non-steroidal anti-inflammatory drug use and the risk of revision of lower joint replacement: A retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-20
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Arief Lalmohamed - Collaborator - University Medical Centre Utrecht
Mohammad Bakhriansyah - Collaborator - Utrecht UniversityOutcomes:
The outcome will be the revision of LJR, i.e., the revision of primary HR or KR which will be based on the CPRD Read Codes (Annex 1).
Description: Technical Summary
We aim to evaluate the association between NSAIDs and the risk of revision of LJR. We will conduct a retrospective cohort study in patients who underwent primary LJR, i.e., HR and KR surgery using the CPRD data. We will limit our data to most likely an elective primary surgery. The exposure for this study will be either current, recent, or past use of NSAIDs. Nonusers will be defined as patients without any prescription of NSAIDs for the entire follow-up time. For NSAID users, they might also be defined as Ânon-users if a total duration of either single or consecutive prescription of any NSAIDs were <3 weeks, or if they have no NSAID prescription following past use, or during a 3-week period following primary LJR. We will stratify our analyses based on the sub-groups of NSAIDs, the duration of current NSAID use, and joint replaced. The outcome will be the revision of LJR. We will consider age, sex, body mass index (BMI), co-medications, co-morbidities, and lifestyle factors as potential confounders. The risk of revision of LJR for NSAID use will be estimated by using Cox proportional hazard with time-dependent covariates. All potential confounders will be taken into account to estimate the adjusted hazard ratios.
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Nature and duration of lipid modifying therapy prescription in response to potential statin intolerance in the UK: an observational study — Kausik Ray ...
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Nature and duration of lipid modifying therapy prescription in response to potential statin intolerance in the UK: an observational study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-22
Organisations:
Kausik Ray - Chief Investigator - Imperial College London
Ailsa McKay - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes:
Time-to-discontinuation or reduction of first trialled statin regimen
- Time-to-discontinuation or reduction of LMT regimen trialled post-discontinuation/reduction of first statin therapy regimen
- Time-to-discontinuation of all statins after commencing first statin regimen
- Days per year of follow-up covered by LMT prescription after commencing first statin regimenDescription: Technical Summary
Aim: To investigate the nature and duration of lipid-modifying therapy (LMT) prescribed in response to potential intolerance to first statin
Study design: Historical open cohort study
Observational period: 1998-2016
Population: A UK primary care cohort, LMT-naïve at baseline, initiated on first statin between 1998-2014
Analyses and outcomes: Descriptive analyses will be undertaken, exploring:
1. Time-to-statin discontinuation (first break in statin coverage for >90 days)
2. Time-to-potential statin intolerance (= any of treatment discontinuation for >90 days, switching to a lower statin dose or alternative statin type of the same or lower intensity)
3. The short-term responses to potential statin intolerance: extent and nature of re-initiated or alternative LMT commenced within 180 days of expiration of prescription of original statin regime
4. Time-to-discontinuation or reduction of the response treatment (where applicable)
5. For statin and non-statin therapies: means days per year covered by prescription, for each year of follow-up post-initiation of first statinSubgroup analyses: the above outcomes will be described for the full cohort, with survival on first statin regime additionally described by CVD risk category and nature of statin therapy, and survival on treatment initiated in response to potential statin intolerance described by the nature of LMT trialled.
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Herpes zoster vaccine and the risk of Bell's palsy and Guillain-Barre Syndrome in the UK — Katherine Donegan ...
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Herpes zoster vaccine and the risk of Bell's palsy and Guillain-Barre Syndrome in the UK
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-22
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Svetlana Buzdugan - Corresponding Applicant - MHRA
Nick Andrews - Collaborator - Public Health England
Philip Bryan - Collaborator - MHRA
Stephanie Dellicour - Collaborator - MHRAOutcomes:
The events of interest include BellÂs Palsy and Guillain-Barré Syndrome
Description: Technical Summary
Herpes zoster vaccination programme was introduced in 2013 in England for prevention of shingles in adults aged 70 years with a phased catch-up programme for those aged 71-79 years. Shingles vaccines have been used in several countries, including the US and Canada. Previous studies have found that Zostavax is safe and well-tolerated. There have been a few cases of Bell's Palsy and Guillain- Barre Syndrome (GBS) reported to the MHRA following exposure to the vaccine. While this is not significantly more than expected, further exploration of the association between Zostavax and risks of Bell's palsy and GBS is considered important as there could be some potential plausibility for a causal association. In this study we will use general practice data linked to other datasets to investigate the potential association and temporal relationship between Zostavax vaccination and an increased risk of the occurrence of Bell's Palsy and GBS among 69-80 years old patients in the UK. Our study population will be patients 69-80 years old who experienced one of the outcomes of interest (GBS or Bell's Palsy) while their practice contributed up to standard records between 1st September 2013 and 31st of December 2018 either in GOLD or Aurum CPRD databases. Using a self-controlled case series design and conditional Poisson regression, the study will provide an estimate of the relative incidence for the two outcomes of interests in the pre-specified risk period post-vaccination compared to other (control) periods outside the specified vaccination risk windows. This will enable investigation of the potential for a causal association between Zostavax vaccine and an increased risk of the events reported through spontaneous reports.
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Dynamic Transmission Model for Rotaviral Infection Before and After Introduction of the Rotarix Vaccine in the UK and Belgium: Modelling Hospital Admission Rates — Katherine Hicks ...
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Dynamic Transmission Model for Rotaviral Infection Before and After Introduction of the Rotarix Vaccine in the UK and Belgium: Modelling Hospital Admission Rates
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-30
Organisations:
Katherine Hicks - Chief Investigator - RTI Health Solutions
Lizzi Esterberg - Corresponding Applicant - RTI Health Solutions
Baudouin Standaert - Collaborator - GSK
Justin Carrico - Collaborator - RTI Health Solutions
Lisa McQuay - Collaborator - RTI Health SolutionsOutcomes:
Hospitalization due to rotaviral infection (HES);
Hospitalization due to AGE (HES)Description: Technical Summary
The purpose of this study is to develop a dynamic transmission model to simulate rotavirus disease over time, including after introduction of the rotavirus vaccine. The goal of the model is to measure the impact of varying key factors (vaccine effectiveness, timing of vaccine introduction, etc.) on rotavirus disease control after the introduction of rotavirus vaccine in either the UK or Belgium. The primary outcome of interest for assessing disease control will be number of hospitalizations by age between 2011 and 2018. As tests to determine the pathogen underlying acute gastroenteritis (AGE) infections are not always performed, and under-coding of rotavirus has been documented in the literature, the model outcomes may include hospitalizations for rotaviral infection as well as for AGE more broadly.
The model will use CPRD data on hospitalizations to calibrate model inputs for rotavirus transmission risk per contact during peak and non-peak seasons and possibly the proportion of rotavirus cases requiring hospitalizations. We will also use CPRD Gold data to assess rotavirus vaccine coverage/completion to populate model inputs. Additionally, we will explore whether lab-confirmed rotavirus and incidence of rotavirus-related outcomes (primarily hospitalization) vary between vaccinated and unvaccinated children.
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Hypertension detection and cardiovascular outcomes: a retrospective cohort study using data from the Clinical Practice Research Datalink database — Louis Steven Levene ...
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Hypertension detection and cardiovascular outcomes: a retrospective cohort study using data from the Clinical Practice Research Datalink database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-14
Organisations:
Louis Steven Levene - Chief Investigator - University of Leicester
Louis Steven Levene - Corresponding Applicant - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Joanne Miksza - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Nicola Walker - Collaborator - University of Leicester
Richard Baker - Collaborator - University of Leicester
Samuel Seidu - Collaborator - Leicester Diabetes CentreOutcomes:
The cohort will be divided into the following four groups:
a. Reference group (normal blood pressure and no prior read code for hypertension)
b. Raised blood pressure and no prior read code for hypertension
c. Raised blood pressure and prior read code for hypertension
d. Normal blood pressure and prior read code for hypertensionPrimary outcomes:
Rates of all-cause and cardiovascular mortality and incidence of cardiovascular disease in the four cohorts
Secondary outcomes:
Description of baseline characteristics of the four groups
Co-morbidities (diabetes mellitus, coronary or ischaemic heart disease, stroke, transient ischaemic attacks (TIA), peripheral arterial disease, obesity, chronic kidney disease)
Lifestyle
o Smoking statusDemographic
o Age
o Gender
o Ethnicity (subdivided into white, Afro-Caribbean, South Asian, other- including mixed)
o Patient level deprivation score (IMD 2015)
o Prescriptions (numbers for British National Formulary code groups, e.g. blood pressure-lowering, lipid modification, diabetes) from previous yearDescription: Technical Summary
Hypertension is a common risk factor for cardiovascular mortality. It is the leading risk factor for premature death, stroke and heart disease worldwide (ref WHO 2012). It has been estimated that the global economic burden of increased blood pressure consumes US$370 billion worldwide and 10% of healthcare expenditures (ref Gaziano). Failure to detect hypertension influences mortality rates; higher proportions of the population on general practice hypertension registers are associated with lower premature mortality. However, a comparison of Quality and Outcomes Framework (QOF) hypertension registers and Health Survey for England (HSE) data indicates that a substantial proportion of patients with hypertension are not documented, and the literature for explaining this is limited.
After adjusting for patient characteristics and other relevant factors, we will undertake Cox survival analysis to compare outcomes (mortality and incidence of cardiovascular disease ) between 4 cohorts of patients:
a. Reference group (normal blood pressure and no prior read code for hypertension )
b. Raised blood pressure and no prior read code for hypertension
c. Raised blood pressure and prior read code for hypertension
d. Normal blood pressure and prior read code for hypertensionBy quantifying the current additional risks associated with raised blood pressure, we hope to inform local practices and policy makers in particular about the need to improve hypertension detection and control. In addition, if factors associated with failure to diagnose hypertension are identified (such as demographic characteristics including age, gender, or ethnicity), then, by sharing these findings with services, we anticipate that more patients not identified earlier can be added to hypertension registers and receive appropriate treatment within a 1 to 3-year time frame. In addition, we may identify factors for targeting patients by primary care teams to improve follow up until a diagnosis is made.
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Utilization, safety and effectiveness of pharmacological therapy in gestational diabetes — Samy Suissa ...
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Utilization, safety and effectiveness of pharmacological therapy in gestational diabetes
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-22
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
YA-HUI YU - Collaborator - Georgia State UniversityOutcomes:
Our outcomes of interest include maternal and perinatal outcomes (preterm birth, birth weight, small for gestational age (SGA), large for gestational age (LGA), macrosomia, neonatal hypoglycaemia, birth injury, neonatal intensive care unit (NICU) admission, glycemic control, preeclampsia, pregnancy-induced hypertension, gestational weight gain), in addition to offspring-related long-term outcomes (height, weight, body mass index (BMI), metabolic abnormality, neurodevelopment disorders (NDD), and maternal long-term outcomes (recurrence of GDM, incident type 2 diabetes)).
Description: Technical Summary
Gestational diabetes mellitus (GDM), defined as glucose intolerance during pregnancy, has detrimental impacts on short and long-term health outcomes of mothers and offspring. Insulin is a first-line treatment for GDM not controlled through diet that creates patient burden with more medical visits and administration via injection. Oral hypoglycemic agents (OHAs), such as metformin or glyburide, may be viable alternatives to insulin, but placental drug permeation presents safety concerns requiring further investigation. There is no clear consensus on the effectiveness and safety of OHAs due to the limitations of the evidence, including small sample trials, different diagnostic criteria, and few long-term follow-up studies. Although OHA use has not been authorized during pregnancy, it is recommended in guidelines and frequently used off-label. It is crucial to quantify real-world use and to evaluate effectiveness and safety of OHAs versus insulin with large samples and appropriate methods.
Thus, we propose a comprehensive evaluation of GDM treatment in a populated-based cohort of women with GDM. We will (1) describe the utilization, patient demographic and clinical characteristics of GDM treatments; (2) examine the effectiveness and safety of GDM treatments on short-term outcomes (e.g., preterm birth, birth weight) and long-term outcomes (e.g. GDM recurrence). Using CPRD pregnancy registry, CPRD Gold, the mother-baby linkage, and Hospital Episode Statistics, our study will include all pregnancies from women with GDM and no prior history of diabetes identified from 1998 to March 2018. We will first describe the prescription patterns of different GDM treatments by year and maternal demographics and comorbidities. Binomial regression will estimate the risk difference and risk ratios of binary outcomes comparing use of metformin versus glyburide and metformin versus insulin. Marginal structural Cox models will be applied for time to event outcomes accounting for time-varying confounders by weighting by high-dimensional propensity score (hdPS).
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The effect of non-pharmacological asthma management tools on preventing asthma exacerbations in children and adults in England — Jennifer Quint ...
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The effect of non-pharmacological asthma management tools on preventing asthma exacerbations in children and adults in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
1.     Annual incidence of each non-pharmacological intervention
2. Stratified incidence by certain patient characteristics
3. Crude and adjusted exacerbation rate ratiosDescription: Technical Summary
Asthma patients will be identified from CPRD using a validated method. CPRD patients will be linked to their HES records to identify asthma attacks treated in both primary and secondary care. The annual incidence of multiple non-pharmacological asthma interventions will be measured between 2004 and 2018 and stratified by patient characteristics including age, gender and asthma severity. These will include asthma management plan, an annual asthma review, an inhaler technique check, smoking cessation where appropriate and influenza vaccination.
To determine the association between non-pharmacological interventions and asthma exacerbations an open cohort study will be carried out. Patients will be followed-up for one year after each intervention and rates of exacerbations will be measured using Poisson model. Both time to first analysis and multiple events (using repeated measures) will be assessed. Exposure will be each intervention and adjusted for known measurable confounders including demographics, clinical characteristics, medication adherence and healthcare utilisation.
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Psoriasis and the risk of cancer incidence and mortality: a cohort study — Darren Ashcroft ...
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Psoriasis and the risk of cancer incidence and mortality: a cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-14
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Alex Trafford - Corresponding Applicant - University of Manchester
Christopher Griffiths - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Cancer incidence recorded in primary or secondary care; Cancer mortality; negative control outcomes (hernia operation; glaucoma operations).
Specific cancers of interest are the 20 most commonly diagnosed within the UK, with the addition of cancers previously suggested to be associated with psoriasis, smoking, alcohol consumption or obesity: bladder, brain/CNS, breast, cervical, colorectal, endometrial, gallbladder, Hodgkin lymphoma, keratinocyte, kidney, laryngeal, leukaemia, liver, lung, malignant melanoma, multiple myeloma, nasal cavity, non-Hodgkin lymphoma, oesophageal, oral cavity, ovarian, pancreatic, pharyngeal, prostate, stomach, thyroid and uterine.Description: Technical Summary
The association between psoriasis and cancer remains unclear, with regards to both overall cancer and specific cancers. The aim of this study is therefore to explore whether individuals with psoriasis are at an increased risk of developing cancer, and dying due to cancer, compared to the general population.
In order to achieve these aims, retrospective matched cohort studies will be conducted using both CPRD GOLD and CPRD Aurum. Psoriasis patients will be extracted using a Read code diagnosis of psoriasis from within the health record. Psoriasis patients with linkage to HES, ONS and IMD records and placement in a practice with at least 12 months up to standard practice registration will be matched to 6 psoriasis-free comparison patients by sex, age and general practice. For psoriasis cases, follow-up will begin at the date of first psoriasis record after 1 year of registration in an up to standard practice. For controls, follow-up will begin at the same date as the psoriasis patientÂs index date. For both cases and comparison patients, follow up will end at the first to occur of; first cancer diagnosis (primary outcome 1), cancer death (primary outcome 2), death from any cause other than cancer, transfer out of the practice, last date of data collection or the end of the study period. Cancer outcomes of interest will be identified using both Read and ICD-10 codes. Cox proportional hazard models will be used to examine the risk of cancer and cancer mortality in patients with psoriasis compared to those without psoriasis. The analyses will examine the impact of other risk factors including psoriasis severity, smoking status, alcohol consumption and BMI.
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The effect of smoking on BMI amongst COPD patients compared with controls: a retrospective cohort study using the CPRD GOLD database — Frank de Vries ...
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The effect of smoking on BMI amongst COPD patients compared with controls: a retrospective cohort study using the CPRD GOLD database
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-21
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Frits Franssen - Collaborator - CIRO
Johanna Driessen - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Peymane Adab - Collaborator - University of Birmingham
Rachel Jordan - Collaborator - University of Birmingham
Spencer Keene - Collaborator - Utrecht UniversityOutcomes:
Time-to-first event of a greater than or equal to a clinically relevant 5% decrease or 5% increase in BMI from baseline are the primary outcomes of interest. A 5% increase and a 5% decrease in BMI will be separate outcomes with separate hazard ratios (HR) in each of the study cohorts (i.e. four estimates total). Patients with a change in BMI <5%, and patients without a second BMI measurement will be censored at the earliest of the date of death, date of transfer out of the practice, and the end of data collection.
Description: Technical Summary
The main objective of this study is to assess the change in body-mass index (BMI) in chronic obstructive pulmonary disease (COPD) and non-COPD (i.e. controls) cohorts by current, former, and never smoking status measured in a time-varying manner.
One well-conducted study investigated this topic but had poor generalisability and was underpowered to examine the effect of smoking status among COPD patients. Another study also could not examine the effect of smoking status in COPD patients and had only 3-years of follow-up. Neither study examined BMI, which is a measure of body composition that is more accessible in primary care settings. Importantly, none of the previous studies assessed smoking in a time-varying manner. A time-dependent analysis of smoking on BMI will account for changes in smoking behaviour over time, which has not been explored previously.
A cohort of patients aged ?40 years with a recorded Read code (in CPRD) for COPD during the period of valid data collection (from 1 January 2005 to present) and a second cohort of controls without a COPD Read code will be followed from their index date until the date of death, date of transfer out of the practice, the end of data collection, or outcome of interest, whichever comes first. Both cohorts will be grouped into current smoking, former smoking, and never smoking groups over 90-day periods in order to examine the effect of smoking status - measured time-dependently - on clinically relevant change in BMI.
Source -
An evaluation of patient outcomes for Type 2 Diabetes Mellitus (T2DM) patients prescribed dipeptidyl peptidase-4 (DPP4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors or Sulphonylureas (SUs) at first intensification — Phil McEwan ...
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An evaluation of patient outcomes for Type 2 Diabetes Mellitus (T2DM) patients prescribed dipeptidyl peptidase-4 (DPP4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors or Sulphonylureas (SUs) at first intensification
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-02
Organisations:
Phil McEwan - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Michael Hurst - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
David Strain - Collaborator - University of Exeter
Marc Evans - Collaborator - Llandough Hospital
Minesh Unadkat - Collaborator - Takeda - Japan Headquarters
Simon Meadowcroft - Collaborator - Takeda - Japan Headquarters
Thomas Mason - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )Outcomes:
The following health outcomes will be derived and analysed:
 6- and 12- month HbA1c change from baseline;
 6- and 12- month body weight change from baseline;
 Discontinuation rates (treatment switch/cessation) at 6- and 12-months post-baseline;
 Treatment intensification (treatment switch/addition) rates at 6- and 12- months post-baseline;
 Mean across medications
 Medication persistence
 Genital/urinary tract infection rates;
 Hypoglycaemic episode counts;
 Rates of the following adverse events: hypoglycaemia, bacterial genitourinary infection, fungal genital infection, fractures, lower limb amputation, pancreatitis, ketosis/diabetic ketoacidosis (DKA), heart failure and cardiovascular events (acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, peripheral vascular disease (PVD)).Description: Technical Summary
Patient-level data will be extracted from CRPD to retrospectively analyse a cohort of T2DM patients (>/=18 years of age) who were prescribed both metformin and one of three medications between 01-01-2002 and 31-12-2017:
- SU's;
- DPP4i's;
- or SGLT2i's.HbA1c and other key outcomes including body weight and discontinuation/treatment intensification rates between date of dual therapy initiation and 6- and 12- months post will be compared by class of drug to understand the real-world effectiveness of the different treatment options available. Multivariable statistical analyses will test for statistically significant differences between drug class to determine if the hypothesis, that there is no difference between drug class holds true.
Secondary outcomes within the study have been derived to understand whether per drug classification, there exists notable differences between both medication usage and toxicity-based event counts. The medication possession ratio (MPR) will be used to calculate adherence to understand its impact on effectiveness. Secondary outcomes will be tested for significant difference.
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Effect of Long-Term Exposure to Anticholinergic Drugs on Dementia, an Emulated Target Trial — Joan Forns Guzman ...
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Effect of Long-Term Exposure to Anticholinergic Drugs on Dementia, an Emulated Target Trial
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-21
Organisations:
Joan Forns Guzman - Chief Investigator - RTI Health Solutions
Joan Forns Guzman - Corresponding Applicant - RTI Health Solutions
Anita Tormos - Collaborator - RTI Health Solutions
Barbra Dickerman - Collaborator - Harvard University
Jaume Aguado - Collaborator - RTI Health Solutions
Lia Gutierrez - Collaborator - RTI Health Solutions
Xabier Garcia de Albeniz - Collaborator - RTI Health SolutionsOutcomes:
Dementia
Description: Technical Summary
This study aims to evaluate the risk of dementia in patients initiating treatment with anticholinergic (AC) drugs. We will evaluate this in two different drug classes: antidepressants and antihypertensive drugs. We will compare patients initiating treatment with AC drugs compared with untreated patients and, with patients initiating treatment with similar drug classes but without AC properties. We will use a target trial emulation approach to ease interpretability, avoid selection bias and yield absolute estimates of risk of dementia, as opposed to the currently existing case-control studies.
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Trends in cancer incidence and mortality in people with pre-diabetes and diabetes among different ethnicities — Karen Brown ...
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Trends in cancer incidence and mortality in people with pre-diabetes and diabetes among different ethnicities
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-30
Organisations:
Karen Brown - Chief Investigator - University of Leicester
Suping Ling - Corresponding Applicant - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
1.     All-sites cancer incidence (diagnosis codes in HES and CPRD)
2. All-sites cancer mortality (causes of death in ONS death registration)
3. Site-specific cancer incidence: 13 cancers including pancreatic, liver, gallbladder, female breast, endometrial, thyroid, colorectal, gastric, bladder, kidney, oesophagus and ovarian cancer and multiple myeloma. (diagnosis codes in HES and CPRD)
4. Cancer-specific mortality: 13 cancers including pancreatic, liver, gallbladder, female breast, endometrial, thyroid, colorectal, gastric, bladder, kidney, oesophagus and ovarian cancer and multiple myeloma. (causes of death in ONS death registration)Description: Technical Summary
Using data from Clinical Practice Research Datalink (CPRD) with linkage to Hospital Episodes Statistics (HES) and Office of National Statistics (ONS) Death Registration, we will investigate the trends in cancer incidence and mortality in people with pre-diabetes and diabetes to identify possible cancer screening window. Participants with a first ever HbA1c measure between 6.0%-6.4% or a diagnosis of pre-diabetes and no prescriptions of glucose-lowering drugs and diagnosis codes of any types of diabetes will be extracted as pre-diabetes groups. They will be followed-up from the date of confirmed pre-diabetes to outcomes of interest occurred, the diagnosis of diabetes, death, transfer-out the practice, last data collection date, whichever came first. Participants with a first ever diagnosis code of diabetes will be extracted as the diabetes group, and they will be followed-up from the diagnosis of diabetes to outcomes of interest occurred, death, the latest available of HES linkage, whichever came first. Age-Period-Cohort (APC) analysis discerns three types of time varying phenomena: Age effects, period effects and cohort effects. In our study, APC analysis incorporated with Lexis Diagram Observations will be applied to quantitatively assess the effect of age, calendar year and durations of (pre-)diabetes on the cancer. Trends in cancer incidence and mortality, by all-sites and site-specific, will be modelled with Poisson Regression, rates in people with pre-diabetes and diabetes will be presented by age, durations and calendar year. These will help to identify the time window to implement cancer screening among people diagnosed with diabetes, site-specific cancers as outcomes will provide information on which types of cancer should be screened. Given the high risk of diabetes and diabetes-related complications in South Asians and differences in cancer outcomes by gender, these analyses will be stratified by White and South Asians, and by male and female, to demonstrate the potential inequities among ethnicities and sex.
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An exploratory study of antibiotic prescribing in the CPRD Aurum database — Martin Gulliford ...
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An exploratory study of antibiotic prescribing in the CPRD Aurum database
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-05-28
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)Outcomes:
Antibiotic prescriptions: using codes that represent all drugs in section 5.1 of the British National Formulary, excluding drugs for TB and Leprosy and methenamine.
Description: Technical Summary
This proposal is for a descriptive study of antibiotic prescribing in the CPRD Aurum database. Antibiotic prescribing in primary care is receiving a lot of attention at present because of growing concern about the problem of antimicrobial drug resistance. We have reported several studies of antibiotic utilisation based on analysis of data derived from the Vision practice-system from the CPRD GOLD database, others have reported similar results using the THIN database. The studies show that there are high antibiotic prescribing rates in the UK. The most common indications for antibiotic prescribing are for respiratory, genito-urinary and skin conditions. However, about half of antibiotic prescriptions may not have coded indications recorded, with either no codes, non-specific codes or repeat prescriptions recorded. This study aims to find out whether similar patterns of antibiotic drug use are also observed in CPRD Aurum data. A sample of patients will be taken from the denominator file to give about 100,000 patients of whom about 60,000 may have been prescribed antibiotics in any year. We will estimate antibiotic prescribing rates by age and gender. We will evaluate antibiotic prescribing rates separately for respiratory, genito-urinary and skin conditions. We will evaluate uncoded antibiotic prescriptions including no codes recorded, non-specific codes recorded and recorded repeat prescriptions. We will compare the results with estimates form the CPRD Aurum database. This will enable us to gain basic familiarity with the CPRD Aurum data and to see whether patterns of antibiotic prescribing are similarly recorded in the GOLD and Aurum databases. This will enable us to plan future studies.
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The London COPD Cohort – Consent to Contact — Royal Brompton Hospital...
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The London COPD Cohort – Consent to Contact
Legal basis:Consent To Contact
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-19
Opt Outs: no information provided./p>
Organisations: Royal Brompton Hospital
Description: Chronic obstructive pulmonary disease (COPD). Academic
Source
2019 - 04
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Understanding the socioeconomic and geographical determinants of dementia care pathways — Frances Darlington...
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Understanding the socioeconomic and geographical determinants of dementia care pathways
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-17
Organisations:
Frances Darlington-Pollock - Chief Investigator - University of Liverpool
Frances Darlington-Pollock - Corresponding Applicant - University of Liverpool
Asan Akpan - Collaborator - University of Liverpool
Clarissa Giebel - Collaborator - University of Liverpool
Mark Green - Collaborator - University of LiverpoolOutcomes:
Charlson score of comorbidities; all-cause mortality (date of death); Length of in-patient admissions during the study period; Number of out-patient visits; total cost of treatment received (primary care prescribing).
Description: Technical Summary
The CPRD resource will allow us to examine the utilisation of primary and secondary care in older adults (65+) and people with young-onset dementia (aged 18-64) in England. As a longitudinal multi-method quantitative study, we will focus on applying innovative sequencing approaches to achieve the stated objectives. Extracting individuals with a dementia diagnosis from the CPRD database, we will construct a longitudinal data resource that sequences periods of care including what type of care was received. This will form the inputs to sequence analysis which will classify these trajectories of care over time resulting in a common set of ÂpathwaysÂ. Following interpreting these pathways, we will examine how they relate to multiple health (all-cause mortality, Charlson score of comorbidity calculated at end of follow-up period, length of in-patient admissions, number of out-patient visits) and economic (total cost of treatment according to primary care prescribing) outcomes using regression analyses (both linear and multinomial logistic regression depending on the outcome). We will then explore how our pathways vary by age, sex, socioeconomic (e.g. neighbourhood deprivation) and geographical (e.g. urban and rural status) measures through multi-nominal regression.
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Screening for alcohol-use disorders among primary care patients with depression and consequent risk of hospitalisation — Emily Herrett ...
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Screening for alcohol-use disorders among primary care patients with depression and consequent risk of hospitalisation
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-03
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Adesanya - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Crellin - Collaborator - The Health Foundation
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah Cook - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
 Alcohol screening status (descriptive analysis only)
 All cause hospital admissionsDescription: Technical Summary
In 2019 NICE guidelines recommended screening for alcohol-use in depressed primary care patients. This is important as depression and harmful alcohol use frequently occur together leading to increased morbidity and mortality. Identifying harmful drinking at an early stage through screening presents an opportunity for brief interventions aimed at reducing the impact of risky drinking and improving patient outcomes. However, it is unclear whether these guidelines are being followed in primary care. Additionally, the association between alcohol screening in primary care and outcomes such as hospitalisation rates is unknown.
This study aims to use UK primary care data from the Clinical Practice Research Datalink (CPRD) to identify depressed patients and describe the levels of alcohol screening within this population. We will describe the characteristics of screened and unscreened patients, and use linked Hospital Episode Statistics (HES) data to explore the association between alcohol screening and one-year hospital admissions. We will use Poisson regression to calculate rate ratios comparing the rate of hospital admissions in those who were and were not screened adjusting for a priori confounders such as age and sex.
This study will provide useful information about alcohol screening in depressed patients in UK primary care and investigate the effect this may have on hospital admissions. Understanding these issues is imperative for assessing whether improvements in alcohol screening in vulnerable patients can be made.
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Trajectory of Weight Changes and Persistency/Adherence among Type 2 Diabetes Patients initiating GLP-1 RAs — Tracey Weiss ...
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Trajectory of Weight Changes and Persistency/Adherence among Type 2 Diabetes Patients initiating GLP-1 RAs
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-03
Organisations:
Tracey Weiss - Chief Investigator - Merck & Co., Inc.
Tracey Weiss - Corresponding Applicant - Merck & Co., Inc.
Ajay Mishra - Collaborator - CHEORS
Kristy Iglay - Collaborator - Merck & Co., Inc.
Lingfeng Yang - Collaborator - Merck & Co., Inc.
Richard Carr - Collaborator - Merck Sharp & Dohme - UK
Sampriti Pal - Collaborator - CHEORS
Swapnil Rajpathak - Collaborator - Merck & Co., Inc.Outcomes:
1)Â Â Â Â Proportion of patients who attain ?5% weight loss at 1 and 2 years post-GLP-1 RA initiation
2) Mean/median weight change from baseline at 1 and 2 years post-GLP-1 RA initiation
3) Adherence to GLP-RW- mean proportion of days covered (PDC); proportion of patients with PDC ?0.8.
4) Proportion of patients who discontinue GLP-1RA within 1 and 2 years post-GLP-1 RA initiationDescription: Technical Summary
In order to assess weight change from, adherence to and discontinuation of GLP-1 RA therapy, a retrospective, observational study will be conducted using the Clinical Practice Research Datalink (CPRD) database to identify all Type 2 diabetes (T2DM) patients ? 18 years of age and initiating on GLP-1 RAs as monotherapy or as dual therapy with metformin between January 1, 2010 and December 31, 2016. New users of GLP-1 RA must have one-year of continuous enrolment prior to initiating GLP-1 RA (index date) and for one-year after initiating GLP-1 RA. This study mean weight change as well as the proportion of patients who achieve ?5% weight loss 1 and 2 years post-GLP-1 RA initiation. Adherence will be assessed as proportion of days covered (PDC) ?80% and discontinuation will be defined as a gap >90 days from end of days of supply of a GLP-1 RA prescription; the proportion of patients adherent and the proportion of patients who discontinue will be calculated at 1 and 2 years. Analysis will be descriptive in nature. Statistical tools of mean, median, 95% confidence intervals, standard deviations or standard errors, quartiles (25%, 75%), and range (minimum, maximum) for continuous variables of interest and frequency distributions for categorical variables will be used. Chi square test for categorical variables and one-way ANOVA or t-test, as appropriate, for continuous variables will be performed when comparing proportion of patients who achieved ?5% v. <5% weight loss, adherent v. non-adherent, and discontinued v. non-discontinued. Multiple Logistic Regression will be used to study the strength of association between the independent variables and adherence or discontinuation of index (GLP-1 RA) drug. Kaplan Meier method will be used to estimate the time to discontinuation of index drug.
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Hydroxychloroquine and screening for risk of ocular toxicity  how big is the problem? Epidemiology of hydroxychloroquine prescriptions in the UK Clinical Practice Research Datalink — Fiona Pearce ...
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Hydroxychloroquine and screening for risk of ocular toxicity  how big is the problem? Epidemiology of hydroxychloroquine prescriptions in the UK Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-01
Organisations:
Fiona Pearce - Chief Investigator - University of Nottingham
Fiona Pearce - Corresponding Applicant - University of Nottingham
Anthony King - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Peter Lanyon - Collaborator - Nottingham University Hospitals
Richard Hubbard - Collaborator - University of NottinghamOutcomes:
1) The number of people in the CPRD taking hydroxychloroquine.
2) The length of time that people prescribed hydroxychloroquine continue on the drug.Description: Technical Summary
Background: The Royal College of Ophthalmologists published new guidance in February 2018 on screening for people taking hydroxychloroquine. The new guidance recommends specialist tests undertaken in hospital eye clinics; whereas previous guidance did not. Eye tests are recommended at baseline, 5 years after treatment initiation and annually thereafter. The guideline was published without providing an estimate of the number of people it will affect, and the effect on already over-stretched eye services.
Aims: We aim to estimate the number of people in the UK currently receiving hydroxychloroquine for any indication, and the length of time they continue to take this for, and to use this to provide estimates of the number of additional eye clinic appointments implementing the guideline will require.
Methods: We will identify all people in CPRD Gold who have ever been prescribed hydroxychloroquine. We will estimate the contemporary point prevalence of current hydroxychloroquine using the number currently taking either drug as the numerator and the whole CPRD population as the denominator. We will apply these estimates to the population of the UK to estimate the number of people in the UK currently taking hydroxychloroquine.
We will use prescription data to estimate the length of time each person continues to take hydroxychloroquine. We will use Kaplan-Meier methods to estimate the proportion of people continuing to take hydroxychloroquine at time-points annually 1-20 years after drug initiation. We will use this data to estimate the number of people in the UK requiring hospital eye tests.
Impact: This study will provide information which commissioners of hospital eye services in the UK need to plan how best to implement the recommendations of the guideline.
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Evaluation of referral system and outcome among patients with breast and colorectal conditions — Ahsan Rao ...
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Evaluation of referral system and outcome among patients with breast and colorectal conditions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-25
Organisations:
Ahsan Rao - Chief Investigator - Imperial College London
Ahsan Rao - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Paul Aylin - Collaborator - Imperial College LondonOutcomes:
ÂNumber of urgent referrals
 Rate of appropriate referrals
 Number of routine referrals
 Number of patients seen within National time frame for patients with breast cancer
 Time taken from referral to treatment
 Rate of onco-plastic procedures
 Readmission rate following surgical procedure for breast and colorectal conditionsDescription: Technical Summary
The objective of the study is to assess sensitivity and specificity of the referral from the GPs for benign and malignant breast and colorectal conditions and the impact it has on the patient outcome. For both benign and malignant conditions, we will evaluate the proportion of the patients that were urgently or routinely referred to the specialty clinic, the proportion of the patients that were incorrectly referred through the urgent cancer pathway, and the proportion of benign conditions that were first managed in the community before they were referred to the specialty clinic. This is particularly important as previous studies have shown that patients undergo severe stress when referred through the cancer pathway and they continue to be anxious until they are diagnosed with having a benign condition. Moreover, the national guidelines on breast cancer management (2016) recommend onco-plastic treatment for patients with newly diagnosed curative breast cancer. Currently, a significant proportion of breast surgeons are still not trained in onco-plastics. Hence, it will be important to know the proportion of patients with breast cancer who had onco-plastics treatment and whether there are any regional differences.
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Differences in risk of long-term cardiovascular and renal outcomes between men and women after a reduction in kidney function following initiation of a renin-angiotensin system inhibitor — Laurie Tomlinson ...
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Differences in risk of long-term cardiovascular and renal outcomes between men and women after a reduction in kidney function following initiation of a renin-angiotensin system inhibitor
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-03
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah-Jo Sinnott - Collaborator - Not from an Organisation
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
End stage renal disease, myocardial infarction, heart failure, and all-cause mortality
Description: Technical Summary
We will use a cohort study to investigate if a fall in estimated glomerular filtration rate (eGFR) is associated with adverse cardiovascular and renal outcomes in patients receiving a new prescription for a renin-angiotensin system inhibitor (angiotensin converting enzyme inhibitors [ACEI], angiotensin receptor blockers [ARB]). We will use the Clinical Practice Research Datalink (CPRD) and linked hospital admission data from Hospital Episode Statistics (HES). We will identify new users of ACEI/ARB, aged 18 or above between 1/1/1997-31/12/2017. In this cohort of new ACEI/ARB users, in order to identify a reduction in renal function following ACEI/ARB initiation, we will restrict to those with records for both a pre-ACEI/ARB initiation serum creatinine (SCr) (recorded in the 12 months before ACEI/ARB initiation) and a post-ACEI/ARB initiation SCr measurement (recorded in the 2 months after ACEI/ARB initiation). We will use Cox regression to compare the hazards of end stage renal disease, myocardial infarction, heart failure and all-cause mortality among those with a decrease in eGFR >/=15% to those with a decrease in eGFR <15%. We will stratify all the effect estimates by sex to determine if there are sex differences in risk of long-term cardiovascular and renal outcomes following a decrease in renal function after initiation of a renin-angiotensin system inhibitor.
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Defining diseases clusters in adults with multimorbidity — Lauren Walker ...
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Defining diseases clusters in adults with multimorbidity
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-22
Organisations:
Lauren Walker - Chief Investigator - University of Liverpool
Lauren Walker - Corresponding Applicant - University of Liverpool
Christian Mallen - Collaborator - Keele University
Frans Coenen - Collaborator - University of Liverpool
Girvan Burnside - Collaborator - University of Liverpool
Kate Fleming - Collaborator - University of Liverpool
Munir Pirmohamed - Collaborator - University of LiverpoolOutcomes:
The primary outcome will be morbidity prevalence and time to accumulation of subsequent disease state(s)
following acquiring an initial diagnosis of multimorbidity (occurrence of second long-term disease).
Secondary outcomes include (a) a taxonomy of commonly occurring disease clusters and (b) Identify the determinants of multimorbidity (such as gender, socioeconomic status, smoking, alcohol, etc)
For analyses relating to multimorbidity incidence, the case cohort will be dynamic and cases will enter at the point at which they acquire a second long-term disease.Description: Technical Summary
Background: The management of patients with multimorbidity is increasingly complex. Reliance on guidelines for the management of single diseases is a major contributor to increasing healthcare burden and polypharmacy. The use of multiple specialists to manage individual disease is costly and burdensome for both the health care service and patients alike, with oversight and support falling to the over-stretched GP. Understanding the scale of multimorbidity across the UK, and in particular the key determinants of different disease clusters along with the factors associated with worse outcomes, is critical to the design of sustainable future services for those with complex care needs that will reduce pill burden, inform future drug development, and provide better models of care.
Aim: To better understand the prevalence and distribution of different patterns of multimorbidity in the UK and the effect on healthcare utilisation and prognosis. Understand the patterns of medicines prescription in relation to multimorbidity clusters, and the key determinants and age distribution of different disease clusters.
Design: Observational descriptive cohort study involving electronic health care records. A novel machine learning cluster algorithm based on Frequent Pattern Mining, similar to Âsupermarket basket analysisÂ, will be used to cluster commonly co-occurring conditions. Comparison to exploratory hierarchical cluster analysis and Cox regression will be undertaken validate the accuracy of the machine approach.
Outcomes: The primary outcome will be time to accumulation of subsequent disease state(s) following acquiring an initial diagnosis of multimorbidity. Secondary outcomes include a) a taxonomy of commonly occurring disease clusters at the numerical level (2, 3, 4 diseases etc) and age group level (18-24 years, 25-30, etc) and b) Identify the determinants of multimorbidity (such as gender, socioeconomic status, smoking, alcohol, etc) in order to better understand the biological basis for disease clustering.
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To evaluate the management of varicose veins in clinical practice in the UK — Julian Guest ...
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To evaluate the management of varicose veins in clinical practice in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-03
Organisations:
Julian Guest - Chief Investigator - Catalyst Health Economics Consultants
Julian Guest - Corresponding Applicant - Catalyst Health Economics Consultants
Graham Fuller - Collaborator - Catalyst Health Economics Consultants
Peter Vowden - Collaborator - Bradford Teaching Hospitals Foundation Trust (bthft)
Robert Bawden - Collaborator - Lindsay Leg Club FoundationOutcomes:
Baseline characteristics of patients who develop varicose veins; Comorbidities of patients who develop varicose veins; Percentage of patients who were referred to a vascular service; Percentage of patients who received treatment and the time to the start of treatment following initial presentation/diagnosis of varicose veins; Distribution of healthcare costs associated with managing varicose veins; Clinical outcomes associated with managing a cohort of patients with varicose veins who were referred to a vascular service; Clinical outcomes associated with managing a cohort of patients with varicose veins who were not referred to a vascular service.
Description: Technical Summary
The objectives are to estimate the patterns of care, clinical outcomes, healthcare resource use and corresponding costs attributable to managing patients with varicose veins over 10 years from initial presentation.
The study population will comprise patients who were ?18 years of age at the time of initial presentation with varicose veins and who had at least 10 years follow-up in their clinical record following initial presentation. Patients will be excluded if they were pregnant or had any type of leg ulcer or had any form of cancer at the time of initial presentation.
Information to be extracted from the patients records includes baseline characteristics, comorbidities, healthcare resource use, prescribed medication and clinical outcomes. Analysis of covariance will be used to adjust for any differences in patients baseline characteristics between patients who were/were not referred to a vascular service.
In addition to descriptive statistics, any differences between patients who were/were not referred to a vascular service would be tested for statistical significance using appropriate non-parametric tests. Multivariate logistic regression would investigate relationships between patients baseline variables and clinical outcomes. KaplanÂMeier analyses might be undertaken to compare the healing distribution between the two groups.
The analysis would estimate the percentage of patients who were referred to a vascular service, the percentage who received treatment for their varicose veins, mean time to referral and mean time to treatment from initial presentation, and the incidence of a range of clinical outcomes including healing and development of venous ulceration of the lower limb.
NHS reference costs would be assigned to the quantity of healthcare resources utilised to estimate the NHS cost of managing patients with varicose veins over 10 years from initial presentation who were/were not referred to a vascular service, followed by sensitivity analyses to assess uncertainty.
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Influence of allopurinol use on hepatotoxicity risk with thiopurine use among adults and paediatrics: a retrospective population-based cohort study — Arief Lalmohamed ...
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Influence of allopurinol use on hepatotoxicity risk with thiopurine use among adults and paediatrics: a retrospective population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-01
Organisations:
Arief Lalmohamed - Chief Investigator - University Medical Centre Utrecht
Arief Lalmohamed - Corresponding Applicant - University Medical Centre Utrecht
Anthonius de Boer - Collaborator - Utrecht University
Erik van Maarseveen - Collaborator - University Medical Centre Utrecht
Jeroen Houwen - Collaborator - Utrecht University
Toine Egberts - Collaborator - Utrecht UniversityOutcomes:
Our primary outcome will be hepatotoxicity. As secondary outcomes we will investigate myelotoxicity and pancreas toxicity.
Description: Technical Summary
Thiopurines are important in the treatment of IBD, but therapy failure is a common clinical phenomenon. Up to 57% discontinues thiopurine therapy, due to either adverse events or limited clinical response. Some of these adverse events are potentially fatal and include hepatotoxicity, myelotoxicity and pancreatitis. (1Â5)(1Â5)
Allopurinol might enhance the risk-benefit ratio of thiopurines. Mechanistically, allopurinol promotes metabolism of thiopurines towards beneficial 6-thioguanine metabolites (6-TGN) rather than the assumed hepatotoxic 6-methylmercaptopurine metabolites (6-MMP). Pharmacokinetic studies have shown that the addition of allopurinol indeed effectively lowers 6-MMP concentrations by 94%, at the cost of increases in 6-TGN concentrations. Based on this mechanism, various IBD guidelines advocate the use of allopurinol, in adjunction with a reduced thiopurine dose (by 50-75%) in patients with skewed thiopurine metabolism.
Evidence on clinical endpoints (rather than pharmacokinetic evidence) on the addition of allopurinol is scarce. Some of the pharmacokinetic studies observed a decreasing trend in hepatotoxicity, but were not powered to study this association more carefully. Moreover, the impact on other toxicity parameters (e.g. pancreatitis) has not been thoroughly studied. Finally, the majority of these studies had a relatively short follow-up time window.
The objectives of this study are therefore to primarily evaluate the rates of hepatotoxicity, and secondary to assess rates of myelotoxicity and pancreas toxicity in adult and paediatrics thiopurine users with or without allopurinol.
Rate ratios for hepatotoxicity, myelotoxicity and pancreas toxicity will be calculated among allopurinol-thiopurine co-users versus thiopurine-monotherapy users. For this purpose, time-dependent cox proportional hazards models will be used, adjusted for potential confounders using propensity scores. All analyses will be stratified based on the defined azathioprine dose reduction category, age, gender and  where relevant  potential effect modifiers. Statistical interaction will be tested using Wald tests.
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The Use of Anti-Estrogens and the Risk of ParkinsonÂs Disease — Samy Suissa ...
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The Use of Anti-Estrogens and the Risk of ParkinsonÂs Disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-30
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Farzin Khosrow-Khavar - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Francois Montastruc - Collaborator - University Of Toulouse
Jean-Louis Montastruc - Collaborator - University Of Toulouse
Laurent Azoulay - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
We will identify all patients within our cohort with a first-time read code for PD recorded any time after cohort entry. The diagnostic code for PD has been previously validated in the CPRD.
Description: Technical Summary
Tamoxifen and aromatase inhibitors (AIs) are widely used for treatment of hormone-receptor positive breast cancer in women. Tamoxifen is a competitive inhibitor of estrogenÂs action on estrogen-receptors. It has been proposed that tamoxifen thus may counter the neuroprotective action of estrogen. However, findings from observational studies regarding the effect of endogenous and exogenous estrogens on ParkinsonÂs Disease (PD) have been inconsistent.
Three recent observational studies have reported that long-term use of tamoxifen (more than six years of cumulative use) is associated with an increased risk of PD. These results are of concern given that women treated with tamoxifen represent an older patient population already at increased risk PD. However, these studies should be interpreted with caution as they had methodological limitations and were not powered to assess the impact of long-term use of tamoxifen and thus the increased risk observed after six years of cumulative use of tamoxifen may be due to chance finding. Thus, the objective of this study is to conduct a large-scale observational study with appropriate methodology to assess the risk of PD associated with use of anti-estrogens (AIs and tamoxifen) in comparison to no-use of anti-estrogens. The study will be conducted in a cohort of post-menopausal women in the general population in CPRD and in a cohort of post-menopausal women newly diagnosed with breast cancer. In secondary analyses, the risk of PD associated with tamoxifen and AIs will be assessed independently. We will also examine the effect of cumulative duration of use of these drugs on risk of PD. This study should provide clinicians and patients with strong evidence regarding the risk of PD associated with tamoxifen and AIs in the real-world setting of clinical practice.
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A comparison of the risk of cardiovascular events and cancers in the ASCEND study cohort and people with diabetes identified using electronic primary care records: a cohort study — Olena Seminog ...
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A comparison of the risk of cardiovascular events and cancers in the ASCEND study cohort and people with diabetes identified using electronic primary care records: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-30
Organisations:
Olena Seminog - Chief Investigator - University of Oxford
Olena Seminog - Corresponding Applicant - University of Oxford
Alison Offer - Collaborator - University of Oxford
Jane Armitage - Collaborator - University of Oxford
Marion Mafham - Collaborator - University of Oxford
Sarah Parish - Collaborator - University of OxfordOutcomes:
The outcomes are myocardial infarction, ischaemic stroke, transient ischaemic attack, coronary and non-coronary revascularisation procedures, major bleedings and all cancers, excluding non-melanoma skin cancer, documented in the patient clinical or referral record, or death certificate. Coronary revascularisation procedures include coronary angioplasty, stenting or coronary artery bypass grafting. Non-coronary revascularisation include peripheral angioplasty or stenting, atherectomy, thrombectomy, embolectomy, catheter directed thrombolysis, arterial bypass surgery and aneurysm repair. Bleeding events will include gastrointestinal, intracranial and admissions for other bleeding.
Description: Technical Summary
We propose to conduct a retrospective cohort study using primary care data to compare the risk of cardiovascular events, cancers, and major bleedings, in a cohort of people with diabetes mellitus registered with a primary care physician in England with risks reported in the Study of Cardiovascular Events in Diabetes (ASCEND). ASCEND is the largest clinical trial reporting on the effect of aspirin and fish oil supplementation on the risk of serious cardio- and cerebrovascular events in people with diabetes mellitus, published in the New England Journal of Medicine in October 2018.
Participants for ASCEND were recruited between 2005 and 2011 by mailed invitation with follow-up information obtained from 6-monthly questionnaires. During the 7.5 year follow-up period a lower rate of events of interest was observed than anticipated. Several explanations have been suggested, including selection of healthier individuals, better compliance with evidence-based therapies within trials, and inappropriate reference populations used to estimate event rates. Importantly, a lower event rate can reflect falling of incident vascular event rates in the general population, which is rarely fully appreciated by researchers when planning trials.
We will use the inclusion criteria developed for the ASCEND trial with some modifications for electronic primary care data. In analysis the exposure condition is diabetes mellitus without vascular diseases. Risk of outcomes is calculated using Cox regression model. We will use the same outcomes as in the ASCEND clinical trial; the primary outcome is myocardial infarction, ischaemic stroke or transient ischaemic attack, or death from any vascular cause, excluding intracranial haemorrhage. The secondary outcomes are gastrointestinal tract cancers and major bleedings. We will then compare these rates with the rates reported in the ASCEND study population. A linkage to Hospital Episode Statistics and mortality statistics will provide information on people with diabetes who were admitted to hospital with outcomes of interest, or died from these conditions.
The findings will inform the interpretation of the ASCEND results, as well as inform the design of future randomized trials.
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An investigation into the association of asthma and fractures — Tricia McKeever ...
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An investigation into the association of asthma and fractures
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-01
Organisations:
Tricia McKeever - Chief Investigator - University of Nottingham
Christos Chalitsios - Corresponding Applicant - University of Nottingham
Dominik Shaw - Collaborator - University of Nottingham
Opinder Sahota - Collaborator - Nottingham University Hospitals
Richard Hubbard - Collaborator - University of NottinghamOutcomes:
Using CPRD linked HES data, the outcomes will be the following:
Primary outcomes
- The point prevalence and incidence of osteoporosis, fragility fracture and subtrochanteric and femoral shaft (atypical) fracture in people with asthma.
- The risk of fragility fracture in people with asthma associated with inhaled (ICS) or oral (OCS) corticosteroids.
- The co-prescription rate of ICS/OCS and bisphosphonates in asthma patients.
- The risk of femoral shaft and subtrochanteric (atypical) fracture associated with bisphosphonate use in patients with asthma.
Secondary outcomes
- The incidence of fragility fractures in people with asthma associated with inhaled or oral corticosteroids.
Description: Technical Summary
The objective of this study is to understand the link between asthma, corticosteroids, osteoporosis and fractures, bisphosphonates and atypical fractures. Specifically, we are interested in the following using CPRD linked HES data:
Determine the point prevalence and incidence of osteoporosis, fragility fracture and femoral shaft and subtrochanteric (atypical) fractures within people with asthma adjusting for the appropriate confounding factors.
- Logistic regression investigating factors associated with prevalence
- Cox regression model determining association between asthma and incidence of a diagnosis adjusting for confoundersTo establish the risk of fragility fractures in patients with asthma due to inhaled or oral corticosteroids.
- Nested case control study defining i) cases as asthma patients with a fragility fracture diagnosis and ii) control asthma patients without a fragility fracture diagnosis.
- Estimating the association between corticosteroids use and fragility fracture by using conditional logistic regressionThe rate of bisphosphonate and steroid co-prescription in asthma and non-asthma patients.
- Establishment of the co-prescription rate in the above two populations by age, gender and calendar year over the whole period for each cohort determining any association.
- Using a Poisson regression model to determine associations between risk factors and co-prescription rate.To examine the risk of femoral shaft and subtrochanteric fractures (known as atypical fractures) due to bisphosphonate use in people with asthma.
- Nested case control study defining i)cases as asthma patients with a femoral shaft or subtrochanteric fracture diagnosis and ii) control group as asthma patients.
- Estimate the association between bisphosphonate use and atypical fractures by using conditional logistic regression
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Safety of five years of pertussis vaccination in pregnancy in England: a cohort study — Helen McDonald ...
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Safety of five years of pertussis vaccination in pregnancy in England: a cohort study
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-17
Organisations:
Helen McDonald - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Grint - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Gayatri Amirthalingam - Collaborator - Public Health England
Helen Campbell - Collaborator - Public Health England
Julia Stowe - Collaborator - Public Health England
Katherine Donegan - Collaborator - MHRA
Maria Peppa - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health England
Philip Bryan - Collaborator - MHRA
Punam Mangtani - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary: Stillbirth; maternal death; neonatal death
Secondary: chorioamnionitis; preterm delivery; post partum haemorrhage; major congenital malformations.Description: Technical Summary
Pertussis vaccination in pregnancy was introduced in the UK in October 2012, in response to a national outbreak with the highest incidence, hospitalisation and death in infants under 3 months old. A recent systematic review identified 16 international safety studies, including 150 000 women. Results are generally reassuring, but there are research gaps. Some (but not all) previous studies found a signal for an association of vaccination with postpartum haemorrhage and with chorioamnionitis (but not its expected consequence of preterm delivery) and length of follow up has been insufficient for ascertainment of congenital malformations diagnosed after birth.
Using a cohort study design, this study will examine whether there is any association between vaccination in pregnancy and adverse maternal, foetal or infant outcomes which are severe (stillbirth, maternal death, neonatal death) or for which specific research gaps have been identified (chorioamnionitis, preterm delivery, postpartum haemorrhage, major congenital malformations) during the first 5 years of the programme. The LSHTM/CPRD Pregnancy Register will be used to identify pregnant women eligible for vaccination.
The main analysis will compare adverse outcomes among women vaccinated in pregnancy to concurrent eligible but unvaccinated pregnant controls. Multivariable Cox regression models will be used to adjust for confounding by gestational age for analyses of stillbirth, maternal death, preterm delivery, and to adjust for length of follow up for analysis of congenital malformations. Multivariable logistic regression models will be used for analyses of neonatal mortality, postpartum haemorrhage and chorioamnionitis. A secondary analysis will examine whether the two different vaccines used during the programme, or vaccination earlier in pregnancy are associated with adverse outcomes. A sensitivity analysis will compare rates of stillbirth, maternal death and neonatal death among women vaccinated in pregnancy to historical controls (matched on maternal age and gestation) using conditional Poisson regression, to update an earlier MHRA analysis.
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Incidence and clinical management of common mental illnesses, and antecedent factors associated with self-harm, among children and adolescents in a UK primary care cohort — Roger Webb ...
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Incidence and clinical management of common mental illnesses, and antecedent factors associated with self-harm, among children and adolescents in a UK primary care cohort
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-30
Organisations:
Roger Webb - Chief Investigator - University of Manchester
Lukasz Cybulski - Corresponding Applicant - University of Manchester
Carolyn Chew-Graham - Collaborator - Keele University
Darren Ashcroft - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Shruti Garg - Collaborator - University of ManchesterOutcomes:
Objective: To estimate annual incidence of mental illnesses in individuals between the ages of 1 and 19 (Study 1).
To examine how risk for fatal and non-fatal self-harm varies according to specific mental illness diagnosis, by total number of mental illness diagnoses given, by type and number of psychotropic drugs prescribed, by area-level socioeconomic status, and by frequency of GP consultations (Study 2). To examine treatment and referral patterns of individuals between the ages of 6 and 19 years who have been diagnosed with an anxiety disorder (Study 3).Aims:
Study 1
i) To estimate the annual incidence of common mental illnesses among individuals between the ages of 1 and 19. The specific conditions examined will be as follows: depression, anxiety disorder, autism spectrum disorder, attention-deficit hyperactivity disorder, conduct disorder, eating disorders, and learning disabilities. The annual incidence for each mental illness will be stratified by age group (1-5, 5-9, 10-12, 13-16, & 17-19), gender and index of multiple deprivation quintile
Study 2:
i) To estimate relative risk of non-fatal and fatal self-harm associated with the following exposures: mental illness diagnosis (depression, anxiety disorder, autism spectrum disorder, attention-deficit hyperactivity disorder, conduct disorder, eating disorders and learning disabilities), as well as index of multiple deprivation quintile and the number of GP consultations and psychotropic drugs prescribed in the 12 months preceding the first self-harm or suicide event. Based on research conducted in other countries, we expect elevated risk for self-harm (including death from suicide) among individuals diagnosed with a mental illness. In particular, we expect the risk for self-harm to be highest in individuals with eating disorders and conduct disorder, relative to other mental illnesses. Based on previous research that we have conducted using CPRD data(1) on self-harm risk among adults, we also expect number of prescribed psychotropic medications, diagnoses, consultations to positively correlate with self-harm, whilst we expect a positive association between rising levels of deprivation and self-harm risk. Finally, we will estimate the 5 most prevalent comorbid combinations of mental illnesses (e.g., ADHD and anxiety disorder) to examine if some combinations of mental illnesses are more strongly associated with self-harm than others.
Study 3:
i) To estimate the frequency of referrals to mental health services and prescription of psychotropic medication among 6 to 19 year olds 36 months before after being diagnosed with an anxiety disorder or having symptoms of anxiety. Frequency counts will be stratified by age, gender, and practice level IMD quintile, and also whether individuals have a record indicating a categorical diagnosis of an anxiety disorder or symptoms of anxiety and other comorbid mental illnesses (ADHD, autism, conduct disorder, depression, eating disorders and learning disabilities)Rationale:
By addressing these aims we will describe the incidence of mental illnesses of children and adolescents in the UK in the past 16 years. Because studies that report on mental illness incidence are dated, the current understanding of child and adolescent mental illness epidemiology is limited. This is problematic because there is increasing proximal evidence that mental illnesses at a very young age have become considerably more prevalent in recent years. By presenting data for multiple illnesses at the same time and from the same data source, we will provide researchers, clinicians, policymakers and patient groups and other relevant stakeholders with a contemporary and comparative overview that currently is not available (Study 1). Recent evidence shows that some adolescent populations have rising incidence of self-harm. To identify individuals at increased risk we will identify precursors and markers for fatal and non-fatal self-harm among children and adolescents who are registered in primary care. Very little is known about precursors for suicide in younger populations. (Study 2). Finally, we will examine how GPs treat young individuals with anxiety disorders, as currently no primary care clinical treatment guidelines exist, and gaining this new knowledge may usefully inform the development of new evidence-based guidelines. (Study 3).Description: Technical Summary
Objectives and Method:
Study 1: Estimate incidence of common mental illnesses in a cohort of individuals aged 1-19, and examining temporal trends in annual incidence (Cohort study).
Study 2: Individuals aged 10-19 years with an index fatal or non-fatal self-harm episode will be ascertained to build a nested case-control study to estimate relative risk of self-harm and suicide among individuals diagnosed with specific mental illnesses compared to those without, and relative risks in relation to patterns of GP consultation, psychotropic drug prescription, and area-level socioeconomic status. (Nested case-control study)
Study 3: Examine how frequently individuals aged 6-19 years are referred to mental health services, psychotropic medication prescribing patterns, and how often patients consult with their GP 12 months prior to and following an initial diagnosis with an anxiety disorder (Cohort study)
Analysis:
Study 1: Annual incidence will be estimated from the number of incident cases during each calendar year (2003 to 2018) in relation to the total number of individuals at risk. Rates will be stratified by gender, age and practice-level deprivation (IMD quintiles).
Study 2: Conditional logistic regression models will be used to estimate relative risk for non-fatal and fatal self-harm via calculation of exposure odds ratios.
Study 3: We will report proportions of individuals that are hospitalised, referred to mental health services and prescribed specific types of psychotropic medication, after an initial diagnosis with an anxiety disorder. Analyses will be stratified by practice-level deprivation (IMD quintiles) and according to comorbid mental illness diagnoses.
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International migrant healthcare access in England: a population-based linked cohort study of healthcare resource utilisation and mortality amongst international migrants registered with primary care services — Robert Aldridge ...
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International migrant healthcare access in England: a population-based linked cohort study of healthcare resource utilisation and mortality amongst international migrants registered with primary care services
Datasets:GP data, CHESS (Hospitalisation in England Surveillance System); HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; SGSS (Second Generation Surveillance System); COVID-19 Linkages
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-28
Organisations:
Robert Aldridge - Chief Investigator - University College London ( UCL )
Robert Aldridge - Corresponding Applicant - University College London ( UCL )
Alexandra Pitman - Collaborator - UCL Division of Psychiatry
Andrew Hayward - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Claire Zhang - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Neha Pathak - Collaborator - University College London ( UCL )
Pam Sonnenberg - Collaborator - University College London ( UCL )
Parth Patel - Collaborator - University College London ( UCL )
Rachel Burns - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Yamina Boukari - Collaborator - University College London ( UCL )Outcomes:
The outcomes listed in this section relate to the full study outlined. These will only be completed if the feasibility
study on the development of a migrant phenotype is thought to have sufficient validity in order to proceed further. We have chosen outcomes to be in line with another linkage study on migrant health resource utilisation, the Million Migrants study(1) to allow for triangulation of results. These outcomes are of high interest to researchers, health policy makers as well as the international migrants that attended our patient and public involvement workshops.Primary outcomes
1. Health resource utilisation of primary care:
a. Consultations (GP, practice nurse, face to face, telephone)
b. Prescriptions
c. Referrals to secondary care
d. Missed GP appointments
e. Diagnosis of existing health conditions (by sub-groups of conditions)2. Health resource utilisation of secondary care:
a. Hospital attendances (inpatient, outpatient, A&E) attendances
b. Hospital admissions (inpatient)
c. Duration of hospital admission
d. 30 day emergency readmissions
e. Missed outpatient appointments
f. Missed procedures
g. Diagnosis of existing health conditions (by sub-groups of conditions)Secondary outcomes
1. All-cause mortality
2. Cause-specific mortality (by ICD-10 chapter)
3. Avoidable, amenable and preventable mortalityAll outcomes will be explored by sub-groups of health conditions relating to avoidable causes of death, sexual and reproductive health conditions and mental health conditions. These are described in detail in Section N. Exposures, outcomes and covariates.
Description: Technical Summary
International migrants are defined as people that move countries either by choice (for work, study or family reasons) or due to conflict, persecution and natural disasters (e.g. refugees and asylum seekers). Despite 8.6 million people or 15.6% of the English population being classed as international migrants, there are no large-scale studies of their health service uptake and it is therefore unclear whether there is an unmet need within this population. Existing studies are limited by small sample sizes or the use of proxy markers for migration e.g. ethnicity. Our research group is currently conducting a large linkage study of migrant records held at Public Health England to Hospital Episodes Statistics (HES) and Office for National Statistics (ONS) mortality data - the Million Migrants study. A major limitation of the Million Migrants study is that it does not include any primary care data, and therefore provides an incomplete picture of health status and health service usage.
In this study, we will use routinely collected data from CPRD linked to HES and ONS mortality data under the existing UCL license. The first stage of the study will be to assess and evaluated the suitability of using codes for migration in primary care data to study health service uptake by individuals who have experienced migration. If quality and completeness of data permit, we will then examine (a) the pattern and costs of primary and secondary healthcare resource utilisation (b) mortality in the migrant cohort compared to non-migrants. We will describe the patterns and costs by identifying existing health conditions and examining primary and secondary care consultations and admission. We will explore all outcomes according to sub-conditions including preventable causes of inpatient admission, sexual and reproductive health conditions/interventions and mental illness. These have been identified as research priorities through patient and public involvement.
The findings of this study would address the gaps identified in migrant health research as well as define a migrant phenotype which will be made available for other researchers to use in migration health studies of primary data. Findings will be disseminated to a wide range of stakeholders and used to inform policy recommendations to ensure equitable access to health services for this potentially underserved group.
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Prediction of imminent fracture risk in new users of oral bisphosphonates or recently fractured subjects: a multinational European real-world cohort study — Daniel Prieto...
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Prediction of imminent fracture risk in new users of oral bisphosphonates or recently fractured subjects: a multinational European real-world cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-25
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Emese Toth - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Sara Khalid - Collaborator - University of OxfordOutcomes:
Primary outcomes: Major fracture: hip, spine, non-hip non-spine, hip/humerus/wrist
Description: Technical Summary
OBJECTIVES
1. To identify predictors of 1- and 2-year fracture risk (IFR) amongst recently fractured or new users of oral bisphosphonates
2. To combine key risk factors to derive IFR prediction toolsMETHODS
- Data sources: CPRD GOLD linked to ONS mortality and HES inpatient
- Participants: two cohorts: 1.newly diagnosed with fracture, and 2.new users of oral bisphosphonate/s in 2000-2018, with 1+ year of data available.
- Measurements: Known predictors of IFR (ISAC17_128R) will be obtained.
- Outcomes: fracture of hip, major osteoporotic, any (excluding skull and digits)
- Statistics: Lasso regression will be used to identify key predictors of IFR, to be included in prediction formulae. Discrimination and calibration will be assessed using AUC and observed/expected plots respectively. All analyses will be stratified by cohort.
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Maternal post-natal GP checks: exploring the equity of care provision in England — Claire Carson ...
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Maternal post-natal GP checks: exploring the equity of care provision in England
Datasets:GP data, CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-14
Organisations:
Claire Carson - Chief Investigator - University of Oxford
Claire Carson - Corresponding Applicant - University of Oxford
Chris Gale - Collaborator - Imperial College London
Dimitrios Siassakos - Collaborator - University College London ( UCL )
Jenny Kurinczuk - Collaborator - University of Oxford
Yangmei Li - Collaborator - University of OxfordOutcomes:
For descriptive study (objective 1 & 2): record of being offered a six-week check, record of attending a six-week check for the mother, record of a six-week check for the baby, consultations in the first 6-8 weeks post-partum. Record of other (related) consultation(s) in the first 6-8 weeks (e.g. consultation for mental health, physical/pelvic/continence issues, contraceptive/family planning advice), number of consultations (for any reason), or other interactions (e.g. phone consultations) in the first 12 weeks.
For cohort study (objective 3, hypothesis testing): key outcomes for maternal health postnatally, including diagnosis or evidence of treatment/referral for mental health issues (depression, anxiety, psychosis); urinary or faecal incontinence; perineal pain, or records of reported painful sexual intercourse; total number of appointments
Description: Technical Summary
The Better Births report (2016) highlighted the importance of the GP 'six-week postpartum check' in monitoring the health and wellbeing of both mother and baby. However, the maternal checks are being carried out inconsistently. This study aims to:
i) Describe current practice, identifying women who are receiving a six-week postpartum check in England;
ii) Examine the factors associated with not receiving a maternal six-week postpartum check
iii) Assess the evidence that the six-week postpartum check improves outcomes for new mothersData for women who gave birth in England between July 2015 and June 2018 will be drawn from the Pregnancy Register. Where available, a linked baby record will also be used. Descriptive analyses will assess the proportion of women who were offered a check, and how many attended. The patterns of interaction with GP (number, type and timing of consultations) will also be described over the first 12 weeks postpartum. Logistic regression will be used to assess the equity of provision, assessing whether geographic region, maternal age, ethnicity, parity and deprivation are predictors of having a six-week postpartum maternal check, while accounting for similar standards of care within practices.
A cohort analysis will examine whether a six-week maternal check improves women's outcomes. Outcomes will initially be compared in women who were offered a check and those who were not: including urinary and/or faecal incontinence; perineal pain; depression or anxiety. The prevalence of adverse outcomes will be compared and adjusted Odds Ratios calculated using logistic regression. Cox proportional hazards analysis will be used, to account for differing time to follow-up, examine time to first diagnosis, treatment and/or referral.
Demographic characteristics, consultations, diagnoses and treatment, including referrals to specialist care, will be informed by Primary Care data. Linked geographical data on IMD will provide necessary information on deprivation.
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Does anticoagulant choice affect the risk of incident dementia among individuals with atrial fibrillation? A cohort study using linked CPRD-HES data — Charlotte Warren...
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Does anticoagulant choice affect the risk of incident dementia among individuals with atrial fibrillation? A cohort study using linked CPRD-HES data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-30
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Emma Powell - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Fernanda Tapia - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sharon Cadogan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Suhail Ismail Shiekh - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary
 Incident dementia (all-cause)Secondary
 Incident dementia (cause-specific i.e. vascular, AlzheimerÂs disease, mixed etc)
 Incident mild cognitive impairmentDescription: Technical Summary
Atrial fibrillation is common: the lifetime risk is 37% among people aged 55 years and over in the UK. An established risk factor for stroke, it is also associated with an increased risk of dementia and cognitive decline. While guidance from the National Institute of Health and Care Excellence recommends oral anticoagulation for stroke prevention among certain groups with atrial fibrillation, the effect of anticoagulant choice on the incidence of dementia and mild cognitive impairment is not well-understood. In particular, whether dementia risk is affected by drug class (vitamin K antagonists such as warfarin versus direct oral anticoagulants such as apixaban), timing of prescriptions e.g. in relation to stroke and any interaction with patient demographic or clinical characteristics is not well-understood. This is important to inform prescribing policy.
In this cohort study, we will use routinely collected primary and secondary care data to investigate the effect of vitamin K antagonists and direct oral anticoagulants prescribed to older individuals with a new diagnosis of atrial fibrillation on rates of incident dementia and mild cognitive impairment. We will use multivariable Cox regression models to adjust for potential confounding factors, and assess (for vitamin K antagonists) whether effects vary by time in the therapeutic range. We will also undertake a range of sensitivity analyses. These include (1) expanding our outcome definition to include a broader range of causes of dementia, (2) restricting to individuals with linked primary and secondary care data only to improve ascertainment of atrial fibrillation and outcomes, and (3) restricting to individuals diagnosed with atrial fibrillation in primary care to improve accuracy of data on the timing on first anticoagulant prescription. We will carry out similar analyses in a population of stroke survivors to investigate the effect of prior atrial fibrillation and anticoagulant choice on the incidence of post-stroke dementia.
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Describing the characteristics of patients who die of COPD with no evidence of prior diagnosis — Jennifer Quint ...
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Describing the characteristics of patients who die of COPD with no evidence of prior diagnosis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-17
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Alicia Gayle - Corresponding Applicant - Imperial College London
Alexandra Lenoir - Collaborator - Imperial College London
Cosetta Minelli - Collaborator - Imperial College LondonOutcomes:
This is a retrospective cohort study using CPRD data with the aim of examining the characteristics of patients with undiagnosed COPD. Previous research suggests that opportunities to diagnose COPD at early disease stages are missed and that delays of diagnosis can take up to 20 years. As a result, the objective of this study is to investigate the proportion of patients who remain undiagnosed but eventually have COPD as their underlying cause of death, and to compare, among patients who die of COPD, those diagnosed with COPD to those who do not have any evidence of COPD diagnosis in their medical records. Descriptive statistics will be used to describe the proportion of diagnosed vs undiagnosed. We will then use logistic regression models to identify factors associated with no diagnosis of COPD. The results of this study can be used to inform potential disease screening public health initiatives and help identify any potential predictive factors for undiagnosed COPD
mortality.
- Factors associated with not receiving a COPD diagnosis among patients whose underlying cause of death is COPDDescription: Technical Summary
This is a retrospective cohort study using CPRD data with the aim of examining the characteristics of patients with undiagnosed COPD. Previous research suggests that opportunities to diagnose COPD at early disease stages are missed and that delays of diagnosis can take up to 20 years. As a result, the objective of this study is to investigate the proportion of patients who remain undiagnosed but eventually have COPD as their underlying cause of death, and to compare, among patients who die of COPD, those diagnosed with COPD to those who do not have any evidence of COPD diagnosis in their medical records. Descriptive statistics will be used to describe the proportion of diagnosed vs undiagnosed. We will then use logistic regression models to identify factors associated with no diagnosis of COPD. The results of this study can be used to inform potential disease screening public health initiatives and help identify any potential predictive factors for undiagnosed COPD mortality.
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Effectiveness on blood pressure of a switch from a monotherapy amlodipine 5 mg toward a combination amlodipine 5 mg/ bisoprolol 5 mg versus a switch toward a monotherapy amlodipine 10 mg. A cohort study using the United Kingdom CPRD — Caroline Foch ...
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Effectiveness on blood pressure of a switch from a monotherapy amlodipine 5 mg toward a combination amlodipine 5 mg/ bisoprolol 5 mg versus a switch toward a monotherapy amlodipine 10 mg. A cohort study using the United Kingdom CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-04-03
Organisations:
Caroline Foch - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Caroline Foch - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Emmanuelle Boutmy - Collaborator - Merck Healthcare KGaA (Merck Group)
Michael Batech - Collaborator - Merck Healthcare KGaA (Merck Group)
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)
Ulrike Gottwald-Hostalek - Collaborator - Merck Healthcare KGaA (Merck Group)Outcomes:
Average systolic blood pressure variation; Average diastolic blood pressure variation; Controlled blood pressure state; Uncontrolled blood pressure state; First occurrence of peripheral oedema; First occurrence of bradycardia.
Description: Technical Summary
Hypertensive patients, switching from a monotherapy amlodipine 5 mg toward a combination amlodipine 5 mg/ bisoprolol 5 mg (first cohort) or switching toward a monotherapy amlodipine 10 mg (second cohort) between January 2000 and June 2018 will be included in this study. One patient from the cohort 1 will be matched up to 5 patients in the cohort 2 via a propensity score. Patients will be followed until: discontinuation or change in the dosage of amlodipine or bisoprolol, addition of another antihypertensive treatment, patient death, transfer out date, end of study period (December 2018).
The primary objective of this study is to investigate in hypertensive patients, if switching from a monotherapy amlodipine 5 mg toward a combination amlodipine 5 mg/ bisoprolol 5 mg is non-inferior to switching toward a monotherapy amlodipine 10 mg in terms of average systolic blood pressure (BP) variation. The non-inferiority margin was defined based on guidelines on the validation of BP monitors indicate that a difference within 5 mmHg is clinically acceptable. Furthermore, inter-individual visit-to-visit variability within 5 mmHg is common in clinical settings. All the BP measurements within the follow-up period will be considered via a linear mixed effects model for longitudinal data.
The secondary objectives are to compare in these two groups, the average diastolic BP, to describe the natural course of BP and to compare the time to controlled BP. The average diastolic BP will also be assessed via a linear mixed effects model for longitudinal data. The natural course of BP and the time to controlled BP via a Markov model.
The exploratory objectives are to compare in these two groups the incidence of the first occurrence of peripheral oedema and bradycardia. This will be assessed via a Poisson regression.
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Asthma prevalence, morbidity and risk factors in Children and Young People in North West London — Imperial College Healthcare NHS Trust...
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Asthma prevalence, morbidity and risk factors in Children and Young People in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Apr-19
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Asthma. Commercial
Source
2019 - 03
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Epidemiology of Endometriosis in the Adolescent Population — Julia DiBello ...
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Epidemiology of Endometriosis in the Adolescent Population
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-13
Organisations:
Julia DiBello - Chief Investigator - Merck & Co., Inc.
Julia DiBello - Corresponding Applicant - Merck & Co., Inc.
Felipe Arbelaez Casas - Collaborator - Merck & Co., Inc.
Jessica Weaver - Collaborator - Merck & Co., Inc.
Jinghua He - Collaborator - Not from an Organisation
Shawn Moylan - Collaborator - Merck & Co., Inc.Outcomes:
Prevalence and incidence of surgically confirmed endometriosis in UK adolescents; Prevalence and incidence of diagnosed endometriosis (with and without surgical confirmation) in UK adolescents; Prevalence of surgeries during which endometriosis could be visualized in the UK general adolescent population.
Description: Technical Summary
Endometriosis is an inflammatory, chronic, progressive disease defined by the presence of endometrial glands and stroma outside of the uterus. The prevalence and incidence of endometriosis in the adolescent population has been reported in a number of population based on epidemiologic studies in the published literature. Prevalence and incidence estimates likely vary across studies in the published literature due to differing age ranges for the adolescent age group, varying case definitions (some studies required surgical confirmation of endometriosis while others did not), varying medical practice across countries, and differences in study time periods. This retrospective cohort study will build upon the findings from a recent study in the UK population and will extend these findings to estimate the incidence and prevalence, and associated 95% confidence intervals, of endometriosis (with and without surgical confirmation) within a population-based sample of UK adolescents age 10-17 years of age. This study will include participants enrolled in the Clinical Practice Research Datalink (CPRD) during the study period of 2006-2016. Additionally, for the primary objective, hospital episode statistics data (HES) will be linked to the CPRD for eligible patients and will be used to provide surgical evidence supportive of an endometriosis diagnosis.
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Cardiovascular risk prediction in daily practice: can machine-learning based risk prediction models improve the accuracy of risk prediction for individual patients? — Tjeerd van Staa ...
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Cardiovascular risk prediction in daily practice: can machine-learning based risk prediction models improve the accuracy of risk prediction for individual patients?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-31
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Yan Li - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of ManchesterOutcomes:
1.     Conventional model performance of QRISK3, machine-learning models and random effects machine-learning models.
2. Whether QRISK3, machine-learning models and random effects machine learning model predict consistent CVD risks for the same individual patients.Description: Technical Summary
Cardiovascular disease (CVD) is the leading reason for death globally, and risk prediction models such as QRISK are being used to predict risk for individual patients. This protocol will use inclusion criteria and outcome definitions similar to the previously approved ISAC agreement (17_125RMn2). The protocol will use machine-learning based methods of model fitting rather than Cox regression as was done in this previous study. The machine-learning based methods considered in this protocol will be based on statistical learning theory rather than artificial intelligence, which have similarities to conventional statistical methods such as Cox proportional hazard model. This study will replicate the modelling process as used in a recent machine-learning paper that used CPRD data and compare machine-learning models' individual risk prediction and conventional model performance to those predicted by QRISK3. The objective of this study will be to determine the level of uncertainty with the prediction of CVD risk for individual patients when using risk scores such as QRISK3. We will evaluate whether statistical learning theory based machine-learning methods could improve the accuracy of risk prediction for individual patients. Statistical learning based machine-learning methods will be used to model patients' data to acquire risk prediction model. These methods will include support vector machine (SVM) and random Forest. We will replicate the process of the recent paper to tune the machine-learning model. Performance metrics (calibration and discrimination) will be compared to QRISK3. To further assess the model's accuracy on individual risk prediction, practice variability will be incorporated into the models by including general practices as random effects. We then compare individual risk prediction from machine-learning models to the random effects models to assess whether it improves accuracy of individual risk prediction in the context of heterogeneity in populations and data completeness between practices.
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Ethnic differences in the prescribing of anti-diabetic, antihypertensive and lipid-lowering medication for people with and without type 2 diabetes — Krishnan Bhaskaran ...
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Ethnic differences in the prescribing of anti-diabetic, antihypertensive and lipid-lowering medication for people with and without type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-13
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sophie Eastwood - Corresponding Applicant - University College London ( UCL )
Andrew Hattersley - Collaborator - University of Exeter
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Naveed Sattar - Collaborator - University of Glasgow
Nishi Chaturvedi - Collaborator - University College London ( UCL )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ruth Farmer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, IncOutcomes:
Time to first anti-diabetic prescription; Choice of anti-diabetic/ antihypertensive/ lipid-lowering medication; Dose of anti-diabetic/ antihypertensive/ lipid-lowering medication; Monitoring of anti-diabetic/ antihypertensive/ lipid-lowering medication; Time to anti-diabetic/ antihypertensive/ lipid-lowering treatment intensification.
Description: Technical Summary
UK South Asian and African Caribbean people with type 2 diabetes experience worse diabetic control and more cardiovascular complications than the European-origin population; ethnic minority populations without diabetes also experience an excess of most types of cardiovascular disease. Explanations are unclear. Blood pressure and lipid control, crucial to cardiovascular risk reduction for people with and without diabetes, also differ by ethnicity. However, ethnic differences in prescribing for diabetes, hypertension and hyperlipidaemia remain understudied.
Ethnic differences in prescribing anti-diabetic (in people with diabetes), antihypertensive and lipid-lowering medication (in people with and without type 2 diabetes) will be sought, including: i) time to commencement ii) choice of medication, iii) dosage, iv) monitoring and iv) time to intensification (either medication up-titration, addition or class switching) after detection of sub-optimal control.
Primary care electronic medical records will be used. Established algorithms and code lists will define ethnicity, diagnoses and medication use. Data will be analysed using Kaplan-Meier time-to-event methods and logistic, Poisson and Cox regression models (according to outcome), with South Asian or African Caribbean ethnicity as the exposure (baseline category=European). These methods will allow for differences in follow-up time. The potentially confounding or mediating influences of age, sex, smoking, BMI, deprivation, polypharmacy, multi-morbidity, drug adherence, patient engagement and diabetes duration/ HbA1c will be explored.
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Weight change following type 2 diabetes diagnosis and incidence of cardiovascular events and all-cause mortality — Jean Strelitz ...
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Weight change following type 2 diabetes diagnosis and incidence of cardiovascular events and all-cause mortality
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-11
Organisations:
Jean Strelitz - Chief Investigator - University of Cambridge
Jean Strelitz - Corresponding Applicant - University of Cambridge
Amy Ahern - Collaborator - University of Cambridge
Evangelos Kontopantelis - Collaborator - University of Manchester
Nazrul Islam - Collaborator - University of Cambridge
Salwa Zghebi - Collaborator - University of Manchester
Simon Griffin - Collaborator - University of CambridgeOutcomes:
Cardiovascular disease (PRIMARY), all-cause mortality (PRIMARY), cancer incidence (SECONDARY)
Description: Technical Summary
Cardiovascular complications account for the majority of diabetes treatment costs globally. Weight loss following diabetes diagnosis improves cardiovascular risk factors and may lead to diabetes remission and reduction in incidence of cardiovascular disease (CVD) events, cancer, and premature mortality. Results of intensive behavioural intervention trials have shown long-term CVD benefits of large weight losses, however weight loss achieved in these trials may not be achievable in the absence of an intensive intervention, and trial cohorts may not be generalizable to broader patient populations. Furthermore, the timing of weight loss in the diabetes disease trajectory and the duration that weight loss is sustained may affect CVD risk, though this has not been assessed. Although weight management is likely among the most effective methods to reduce diabetes complications at the population level, there are currently no existing policies for interventions focused on weight management in primary care. There is a need for research to identify effective weight loss targets to inform such interventions. Therefore, we aim to characterize weight change trajectories following diabetes diagnosis and determine to what extent weight loss, and distinct weight change patterns, may impact long-term health outcomes among adults with diabetes. We will use latent class analysis to identify patterns of weight change, and will then use Cox proportional hazards regression to estimate hazard ratios of the associations of weight change patterns and 10-year incidence of CVD, other diabetes complications, cancer, and all-cause mortality.
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Sodium channel-inhibiting drugs and cancer survival: a cohort study — William Brackenbury ...
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Sodium channel-inhibiting drugs and cancer survival: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-22
Organisations:
William Brackenbury - Chief Investigator - University of York
Tim Doran - Corresponding Applicant - University of York
Caroline Fairhurst - Collaborator - University of York
Ian Watt - Collaborator - University of York
Martin Bland - Collaborator - University of YorkOutcomes:
Cancer-specific survival; overall survival, cancer-specific outcome (e.g. hospital admission, treatment).
Description: Technical Summary
Voltage-gated sodium channel (VGSC)-inhibiting drugs are commonly used to treat epilepsy and cardiac arrhythmia. VGSCs are also widely expressed in various cancers, including those of the breast, bowel and prostate. A number of VGSC-inhibiting drugs have been shown to inhibit cancer cell proliferation, invasion, tumour growth and metastasis in preclinical models, suggesting that VGSCs may be novel molecular targets for cancer treatment. Surprisingly, we previously found that prior exposure to VGSC-inhibiting drugs may be associated with reduced overall survival in cancer patients, but we were unable to control for cause of death or indication for prescription. The purpose of the present study is to interrogate a different database in order to further investigate the relationship between VGSC-inhibiting drugs and cancer-specific survival. A cohort study using primary care data from the CPRD database will include patients with diagnosis of breast, bowel and prostate cancer. The primary outcome will be cancer-specific survival from date of cancer diagnosis. Cox proportional hazards regression will be used to compare survival of patients taking VGSC-inhibiting drugs (including antiepileptic drugs and Class I antiarrhythmic agents) with cancer patients not taking these drugs, adjusting for cancer type, age and sex. Drug exposure will be treated as a time-varying covariate to account for potential immortal time bias. Various sensitivity and secondary analyses will be performed. The protocol has been peer reviewed and published.
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Developing and validating a novel clinical severity index for cardiovascular disease in primary care — Ralph Kwame Akyea ...
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Developing and validating a novel clinical severity index for cardiovascular disease in primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-18
Organisations:
Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Evangelos Kontopantelis - Collaborator - University of Manchester
Folkert Asselbergs - Collaborator - University College London ( UCL )
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of NottinghamOutcomes:
The health-related outcomes that are expected to be assessed are:
 Mortality outcomes
 Death due to cardiovascular event
 Death due to other causes Morbidity outcomes
 Coronary heart disease (angina, heart attack, heart failure)
 Stroke (ischaemic and haemorrhagic)
 Transient ischaemic attacks (TIAs)
 Peripheral vascular disease
 Atherosclerotic aortic disease Hospitalisation
 Cardiovascular disease-related
 All-cause hospitalisationDescription: Technical Summary
Background: Prevention of cardiovascular disease (CVD) requires timely identification of people at increased risk to target effective interventions. With advances in diagnosis and treatment of CVD and increasing life expectancy, more people are surviving initial CVD events, and secondary prevention risk prediction models are increasingly being utilised. A refined classification of CVD by disease severity could provide a novel tool to identify individuals with increased risk of severe disease and individualise management.
Aim: To develop and validate a novel clinical severity index for CVD severity risk classification in adults with an established CVD.
Study design: Retrospective open cohort
Setting: UK General Practices
Participants: Patients aged 18 years and over, with a first diagnosis of incident non-fatal CVD.
Methods: Use a data driven cluster analysis in patients with newly diagnosed CVD to determine patient clusters based on potential risk factors for severe CVD outcomes. This will be related to retrospective data from patient records on development of severe CVD complications or outcomes. Cox and competing-risk regressions will be used to compare risk of severe CVD complications/outcomes among clusters.
Outputs: A novel risk severity tool built from data-driven methods for use in primary care, aimed at secondary prevention of CVD. The clinical decision tool would sub-stratify patients based on risk of severe CVD outcomes.
The tool will eventually help to tailor and target early treatment to patients who would benefit most from the respective effective interventions that already exist, thereby representing a first step towards personalised medicine in secondary prevent of CVD.
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The impact of the National Data Opt-out programme on representativeness of the Clinical Practice Research Datalink (CPRD) database — Puja Myles ...
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The impact of the National Data Opt-out programme on representativeness of the Clinical Practice Research Datalink (CPRD) database
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-12
Organisations:
Puja Myles - Chief Investigator - CPRD
Susan Hodgson - Corresponding Applicant - CPRD
Helen Booth - Collaborator - CPRD
Rachael Williams - Collaborator - CPRD
Sonam Sadarangani - Collaborator - CPRD
Tarita Murray-Thomas - Collaborator - CPRDOutcomes:
Selected Quality Outcome Framework (QOF) indicator conditions:
- Atrial fibrillation
- Coronary heart disease
- Heart failure
- Hypertension
- Peripheral arterial disease
- Stroke and transient ischaemic attack
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Cancer
- Chronic kidney disease
- Diabetes mellitus
- Palliative care
- Dementia
- Epilepsy
- Learning disabilities
- Mental health
- Osteoporosis
- Rheumatoid arthritis
- Obesity
Selected mortality outcomes:
- Age-standardised all-cause mortality rate (by sex and region)
- Age-specific mortality rates by sex
- Age-standardised cause-specific mortality rates, by sex, for:
~ Cancer
~ Respiratory disease
~ Circulatory disease
~ Mental and behavioural disorders
~ Diseases of the nervous systemDescription: Technical Summary
The National Data Opt-out Policy (NDOP) was launched in May 2018 to enable individuals to opt out of their confidential patient information being used for purposes beyond their individual care. Differential opt-out patterns by socio-demographic characteristics could introduce bias in routine healthcare data sources, like CPRD, that are used for research and healthcare planning, and could therefore impact on the generalisability of research findings that use these data.
The aim of the proposed work is to assess the representativeness of the CPRD primary care database over time. We will assess a) the CPRD patient distribution in terms of demographic characteristics (age, sex, and socioeconomic status), b) the percentage of CPRD patients across different geographies (regions, and rural/urban classification), and c) estimate the prevalence of key indicator conditions and cause-specific mortality.
The study will comprise a series of consecutive monthly cross-sectional descriptive reports. We will use data from each monthly database build, January 2018 - March 2020, with additional analyses in archived versions of the database from the preceding decade. Key outcomes will comprise Quality Outcome Framework (QOF) indicator conditions (including coronary heart disease, diabetes mellitus and dementia), and all cause and cause-specific mortality rates (including deaths from cancer, respiratory disease, and circulatory disease). Analyses will be undertaken in the entire CPRD database population, and in age and/or sex specific groups for certain outcomes.
Descriptive analyses will explore the distribution of key sociodemographic characteristics of the CPRD database population, by rural/urban classification and region, which will be compared to national population statistics. The prevalence of selected QOF indicator conditions and cause-specific mortality rates will be calculated for CPRD population and compared to published national annual QOF outcomes/ONS death registrations.
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The risk of muscular events in new users of individual hydrophilic versus lipophilic statins at equivalent doses: An observational cohort study — Susan Jick ...
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The risk of muscular events in new users of individual hydrophilic versus lipophilic statins at equivalent doses: An observational cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-29
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Alexandra Mueller - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Cornelia Schneider - Collaborator - University of Basel
Evangelia Liakoni - Collaborator - Bern University Hospital
Julia Spoendlin - Collaborator - University of Basel
Stephan Krähenbühl - Collaborator - University of Basel
Theresa Burkard - Collaborator - University of BaselOutcomes:
The rate of muscular events, defined as a composite outcome of myalgia, myositis, and rhabdomyolysis
Description: Technical Summary
We will apply a propensity score matched sequential cohort study design to compare the risk of muscular events between new users of hydrophilic statins (i.e. pravastatin, rosuvastatin) vs lipophilic statins (i.e. simvastatin, atorvastatin, fluvastatin) at comparable lipid-lowering doses. Five comparisons between individual statins are planned; pravastatin vs simvastatin or fluvastatin, and rosuvastatin vs atorvastatin, simvastatin, or fluvastatin, although we may need to drop the latter two because of small sample size. We will conduct analyses separately in patients taking statins for primary cardiovascular prevention (i.e. no previous ischemic stroke or myocardial infarction) and those taking statins for secondary prevention.
We will identify patients aged 40 to 80 years with a first-time prescription for a hydrophilic or lipophilic statin between 2000 and 2017 (cohort entry date). In each comparative analysis, hydrophilic statin users will be (1:1) matched to lipophilic statin users on a propensity score. We will conduct matching within 2 year enrolment blocks to avoid time-trend bias (expanding statin indications over time). After concatenating all matched patients into one cohort, we will follow them from day 1 after cohort entry until the first Read code for myalgia, myositis, or rhabdomyolysis or until they are censored due to treatment cessation, treatment switch to another statin, death, leaving the CPRD, a Read code for an exclusion criterion or reaching the end of study period. We will follow patients for a maximum of 1 year since statin-associated myotoxic events occur predominately shortly after treatment start. We will perform Cox-proportional hazard analyses to calculate hazard ratios with 95% confidence intervals for the risk of muscular events in new users of hydrophilic vs lipophilic statins. We plan to quantify time-specific hazard ratios by duration of follow-up and to conduct subgroup analyses by sex, age, and daily comparable lipid-lowering dose.
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Maternal infections and antibiotic treatment associated with long-term child conditions — Ruth Gilbert ...
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Maternal infections and antibiotic treatment associated with long-term child conditions
Datasets:GP data, CPRD Mother-Baby Link; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-22
Organisations:
Ruth Gilbert - Chief Investigator - University College London ( UCL )
Heng Fan - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Janice Allister - Collaborator - Not from an Organisation
Leah Li - Collaborator - University College London ( UCL )
Linda Wijlaars - Collaborator - University College London ( UCL )
Shabeer Syed - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Primary outcomes:
Our primary outcomes include neurodevelopmental disorders and major congenital malformations including:
 cerebral palsy, epilepsy, attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD)
 major malformation as a whole and individual malformations
 psychiatric disorders as per the ICD-10 and DSM-5.1,2
 chronic conditions in children as defined by Hardelid et al.3The final list of primary outcomes will reflect a refined set of indicators with public health importance of diseases based on machine learning outcomes, prevalence, homogeneity with previous research and input from an expert steering group.
Description: Technical Summary
To analyse the safety of antibiotics use during pregnancy, a key challenge for an observational design is to disentangle associations between specific types of antibiotics and adverse outcomes from the association between the indications for using antibiotics, i.e. infections.
Some maternal infections are known to be fetal-damaging, including genital tract infection, ÂTORCHÂ (Toxoplasmosis, Other agents such as HIV, Rubella, Cytomegalovirus and Herpes simplex) and sexually transmitted infections (STIs)). However, associations are less clear between other common types of maternal infection (e.g. urinary tract infections (UTI), respiratory tract infection (RTI), skin infections and ear infections) and adverse children outcomes, including major congenital malformations, neurodevelopmental disorders and chronic conditions. Therefore, we aim to first determine 1) whether different types of maternal infections (e.g. respiratory tract infection and urinary tract infection) during pregnancy are associated with adverse child outcomes.
We then aim to evaluate 2) whether maternal macrolide antibiotic exposure (versus penicillins) is associated with adverse child outcomes (while adjusting for fetal damaging infections identified in 1)); and whether the association changes according to antibiotics subtypes, exposure timing, and number of recorded prescriptions. The head to head design between macrolides and penicillins minimise the risk of indication bias due to infection, considering macrolides are often prescribed as the alternative for women with suspected allergy to penicillin.
We will use a large UK representative birth cohort of mothers and children, born between 1990 and 2018. Our cohort will be based on the mother-baby link in CPRD, linked to Index of Multiple Deprivation data (IMD).
We will first describe the distribution of antibiotics prescriptions during pregnancy, maternal infections and their correlations. We also derive covariates and adverse outcomes in the dataset. For complex conditions for which diagnoses were unreliably recorded in primary care (e.g. CP), we integrate sources from literatures, clinical expertise and machine learning methods to ascertain the cases.
For the main analysis, we will compute propensity-score adjusted logistic model and Cox proportional hazard models to study the associations with prenatal infection, macrolides versus penicillins, co-variates and a range of adverse outcomes.
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Cardiovascular disease in a general asthma population: UK population study — Jennifer Quint ...
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Cardiovascular disease in a general asthma population: UK population study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-07
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
1.     Annual incidence and prevalence of cardiovascular disease (CVD) including ischaemic heart disease, cerebrovascular disease, arrhythmias and heart failure
2. Risk of CVD incidence and mortality in an asthma population compared to general UK population
3. Risk of CVD associated with incident and prevalent use of long-acting bronchodilators in asthma patients and COPD patientsDescription: Technical Summary
To determine the risk of cardiovascular disease in a general asthma cohort, annual incidence and prevalence rates will be calculated for each cardiovascular outcome (including ischaemic heart disease, heart failure and stroke) and stratified by clinical characteristics between 2004 and 2017. To compare CVD incidence and mortality rates to the general population a matched cohort of asthma patients and randomly identified patients from the total CPRD population will be obtained from CPRD between 2012 and 2017. A multivariate Poisson model, adjusting for cardiovascular risk factors, will be used to obtain rate ratios.
To determine any cardiovascular risk from incident long-acting bronchodilators (LAB) a nested case-control will be carried out from a cohort of incident LAB users. The cases will be acute cardiovascular events and controls will be matched 1:4 on disease risk score and cohort entry date. Conditional logistic regression will be used to estimate the association. Exposure (long acting bronchodilator) will be categorised by type of inhaler and duration of use. The same analysis will also be carried out in a COPD population to see if the findings in a UK population match those found in the Taiwanese population used in the original study.
Source - and 19 more projects — click to show
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Defining obesity cut-off points for the risk of type 2 diabetes, cardiovascular disease, and cancer among minority ethnic groups: a prospective cohort study using population-based linked electronic health records — Rishi Caleyachetty ...
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Defining obesity cut-off points for the risk of type 2 diabetes, cardiovascular disease, and cancer among minority ethnic groups: a prospective cohort study using population-based linked electronic health records
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-18
Organisations:
Rishi Caleyachetty - Chief Investigator - University of Warwick
Rishi Caleyachetty - Corresponding Applicant - University of Warwick
Amitava Banerjee - Collaborator - University College London ( UCL )
Francesco Cappuccio - Collaborator - University of Warwick
Kenan Direk - Collaborator - University College London ( UCL )
Nuredin Ibrahim Mohammed - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Paramjit Gill - Collaborator - University of Warwick
Rebecca Hardy - Collaborator - University College London ( UCL )
Ricardo Uauy - Collaborator - University of Chile
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Thomas Barber - Collaborator - University of WarwickOutcomes:
Type 2 diabetes, myocardial infarction, ischaemic stroke, colorectal cancer, postmenopausal (>55 years) breast cancer, endometrial cancer, death, or transfer out of the practice.
Description: Technical Summary
Aim: We aim to prospectively identify obesity BMI cut-off points for the risk of type 2 diabetes, myocardial infarction, ischaemic stroke, colorectal cancer, postmenopausal breast cancer and all-cause mortality, among adults from minority ethnic groups that are risk equivalent to the current obesity BMI cut-off point set for white populations.
Background: The National Institute for Health and Care Excellence (NICE) and World Health Organization (WHO) definition of obesity, e.g. body mass index (BMI) ? 30 kg/m2 may underestimate risk of chronic disease in non-white adults. Ethnic minority populations have a higher risk of type 2 diabetes at lower obesity BMI cut-off points than white populations. NICE does not consider the evidence sufficiently strong to make recommendations on the use of new BMI cut-off points to classify individual minority ethnics groups as obese.
Methods: We will assemble a cohort of adults, aged ?18 years and free from diagnosed type 2 diabetes, myocardial infarction, ischaemic stroke, colorectal cancer, postmenopausal breast cancer at baseline from white, black, South Asian, Chinese, Arab, and mixed ethnic groups using linked electronic health records covering primary care, hospital admissions, acute coronary syndrome registry and mortality registry (CALIBER platform). Ethnic specific obesity BMI cut-off points related to risk of incident type 2 diabetes, incident myocardial infarction, incident ischaemic stroke, incident colorectal cancer, incident postmenopausal breast cancer and all-cause mortality, respectively will be estimated using Poisson regression, adjusting for age and sex. Analyses will be repeated with additional adjustment for smoking status, and patient-level Index of Multiple Deprivation (IMD) score.
Anticipated impact and dissemination: Anticipated impact among minority ethnic groups includes: (a) increased identification of obesity to trigger culturally-appropriate action to prevent obesity-related chronic conditions; (b) greater awareness of increased risk of chronic disease at lower BMI cut-off points compared with those from white populations; (c) informing NICE Guidelines
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Risk of Nephrotic Syndrome in Children with Atopic Eczema  a matched case-control study — Dorothea Nitsch ...
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Risk of Nephrotic Syndrome in Children with Atopic Eczema  a matched case-control study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-13
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yochai Schonmann - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amanda Roberts - Collaborator - Nottingham Support Group for Carers of Children with Eczema
Amy Mulick - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Collaborator - University of Tsukuba
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Incident nephrotic syndrome diagnosis
Description: Technical Summary
We aim to explore the association between atopic eczema and incident nephrotic syndrome. Atopic eczema is common in the UK, and all but the most severe cases (97%) are treated in primary care. We will be able to ascertain the presence of atopic eczema through the use of a validated algorithm. Nephrotic syndrome is a distinct clinical diagnosis with a small number of related diagnostic codes. To explore the association between atopic eczema and nephrotic syndrome, we will conduct a matched case-control study. We will include all children aged 1-17 years old in CPRD between 1999 and 2018 who had had a first diagnosis of nephrotic syndrome and match each one of them with up to five children of the same age, sex and GP practice, registered in the same time period. We will fit conditional logistic regression models to explore the association between atopic eczema and new diagnoses of nephrotic syndrome, adjusted for age, sex, and socioeconomic status. We will also explore the strength of this association specifically among children with concomitant asthma and atopic eczema and by the severity of atopic eczema, and through a range of sensitivity analyses.
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All Cause and Cardiovascular Mortality in type 2 diabetes patients using Detemir or Glargine — Lina Steinrud Morch ...
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All Cause and Cardiovascular Mortality in type 2 diabetes patients using Detemir or Glargine
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-26
Organisations:
Lina Steinrud Morch - Chief Investigator - Novo Nordisk
Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk
Michael Feher - Collaborator - NHS England
Niels Væver Hartvig - Collaborator - Novo Nordisk
Per Knud Christensen - Collaborator - Novo Nordisk
Rikke Salbol Brandt - Collaborator - Novo Nordisk
Thue Johansen - Collaborator - Novo NordiskOutcomes:
All-cause mortality; cardiovascular mortality
Description: Technical Summary
The impact of different types of basal insulins in patients with type 2 diabetes on risk of death and death from cardiovascular diseases is unclear. Therefore, the aim of this study is to estimate the differences in all-cause and cardiovascular mortality rates between first time users of basal insulins (Detemir vs Glargine) in a population-based study in UK.
Patients with type 2 diabetes aged >/=40, who initiated basal insulin therapy (Detemir or Glargine) in 2004-2018 will be identified from Clinical Practice Research Datalink (CPRD), with comprehensive data on mortality, cause of death, and background variables. The estimates will be adjusted for relevant patient characteristics at time of treatment initiation. Follow-up time will be up to 14 years (median 4 years). Exposure variables are defined in two ways:
- "ITT (Intention to treat)" where patients are allocated to the first used basal insulin throughout follow-up.
- "On treatment of the first drug used" where patients are followed while they are on the first used drug and until time of first switch to another treatment, where they are censored. A "lag time of one year" for each treatment episode is used.The fully adjusted Cox's Proportional Hazard (PH) model will include the exposures of interest and adjustment variables such as age, calendar year, sex, diabetes duration, Body Mass Index (BMI), history of Cardiovascular Disease (CVD), CVD medication and non-insulin glucose-lowering medications at time of insulin initiation. Time dependent variables are assessed i.e. "non-insulin glucose-lowering medications," "bolus insulin" and "smoking status". The study will provide knowledge of comparative mortality among users of insulin detemir compared to users of insulin glargine in real clinical practice. Considering the large number of patients who require
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The evaluation of risk factors and long-term outcomes in patients with community- or hospital- acquired sepsis: a retrospective cohort study using linked primary and secondary care data — Tjeerd van Staa ...
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The evaluation of risk factors and long-term outcomes in patients with community- or hospital- acquired sepsis: a retrospective cohort study using linked primary and secondary care data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-19
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Sian Bladon - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of ManchesterOutcomes:
In-hospital mortality; admission length of stay; critical care length of stay; all-cause mortality (1-year and longer term); mortality with sepsis as one of the causes of death; all-cause readmission rates (1-year and longer term); readmission with hospital diagnosis of sepsis.
Description: Technical Summary
Around 250,000 people develop sepsis each year in the UK, with the majority contracting it in the community. It is a complex condition with a wide range of symptoms, making it difficult to recognise clinically. There are many risk factors associated with developing sepsis such as age, gender and multiple comorbidities. Much of the research into sepsis has involved single hospitals or ICUÂs, with few large population-based cohort studies performed.
The aims of this study are to use linked primary and secondary care data to look at risk factors associated with developing community-acquired and hospital-acquired sepsis, and to see whether increased antibiotic prescribing in primary care increases a patientÂs risk of developing sepsis. The study will be a retrospective cohort study of patients with a hospital diagnosis of sepsis between 2000 and 2018. Patients diagnosed within 48 hours of admission to hospital will be defined as community-acquired, with those diagnosed more than 48 hours after admission classed as hospital-acquired sepsis. ICD-10 codes for sepsis will be used to extract the cohort in the Hospital Episode Statistics (HES) data and the primary care records obtained from the CPRD GOLD dataset. These will also be linked with Office for National Statistics mortality data. Comparator cohorts of patients without a sepsis diagnosis will be created, matched by age, gender, GP practice or duration of hospital stay prior to index date.
Outcomes assessed will be mortality rates, hospital length of stay, critical care length of stay and readmission rates, comparing the two groups of patients. Survival rates will be compared using Kaplan-Meier plots and modelled using Cox proportional hazards regression. Logistic regression modelling will be used to characterise risk factors for the development of sepsis, including age, gender, comorbidity and prescription data. Analyses will be conducted separately for children (age < 18) and adults.
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Prevalence of prescription of blood pressure lowering drugs, statins and aspirin, and their effects on BP and cholesterol when taken alone and together — Kazem Rahimi ...
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Prevalence of prescription of blood pressure lowering drugs, statins and aspirin, and their effects on BP and cholesterol when taken alone and together
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-07
Organisations:
Kazem Rahimi - Chief Investigator - The George Institute for Global Health
Dexter Canoy - Corresponding Applicant - The George Institute for Global Health
Abdul Salam - Collaborator - The George Institute for Global Health
Anthony Rodgers - Collaborator - The George Institute for Global Health
Dexter Canoy - Collaborator - The George Institute for Global Health
Emily Atkins - Collaborator - The George Institute for Global Health
Mariagrazia Zottoli - Collaborator - The George Institute for Global HealthOutcomes:
Distribution of variables including patient characteristics (e.g., age, sex history of cardiovascular disease and diabetes, smoking, number of GP visits), prescriptions (blood pressure-lowering drugs, lipid-modifying drugs, aspirin), mean blood pressure, mean lipid levels)
Description: Technical Summary
Most people with or at high risk of cardiovascular disease (CVD) need long term treatment with drugs for lowering blood pressure (BP), lowering cholesterol, and for platelet aggregation inhibition (e.g. aspirin) as recommended by guidelines major clinical practice guidelines. In such patients, simplification of treatment is critical to long term adherence to these drugs. Typically, data are reported on the rate of prescription of each of these treatments modalities separately. However, few data are available on co-prescription, i.e. concordance with guideline recommendations to prescribe all treatments simultaneously. And furthermore, there are limited data on whether risk factor changes are affected by concomitant use of these drugs. We propose therefore to estimate using an observational cohort study design, the prevalence of use of drugs for BP lowering, cholesterol lowering and aspirin, and to assess their associations with BP and cholesterol levels when they are used alone and together. Data will be analysed using descriptive and inferential statistics including linear regression analysis models. Information from this research will inform strategies to increase uptake of recommended treatments and use of fixed dose combinations (FDCs) for patients with heart disease and stroke.
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Development and internal validation of prognostic scores for risk of lower limb amputation and all-cause mortality in patients at risk of developing diabetic foot problems, and in patients with diabetic foot ulcer — Frank de Vries ...
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Development and internal validation of prognostic scores for risk of lower limb amputation and all-cause mortality in patients at risk of developing diabetic foot problems, and in patients with diabetic foot ulcer
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-07
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Johan Roikjer - Collaborator - Aalborg University Hospital
Johanna Driessen - Collaborator - Utrecht University
Johannes T.H. Nielen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Nicolaas Schaper - Collaborator - Maastricht University
Niels Ejskjaer - Collaborator - Aalborg University Hospital
Patrick Souverein - Collaborator - Utrecht University
Romin Pajouheshnia - Collaborator - Utrecht UniversityOutcomes:
Lower limb amputation (composite, and stratified by site); All-cause mortality
Description: Technical Summary
The study objective is to develop prognostic scores for risk of lower limb amputation (LLA), broken down by limb (toe, foot, lower limb below knee, lower limb above knee), and mortality in patients with diabetic foot ulcerations (DFU) or patients who are at risk of developing DFU.
Two cohorts will be created: 1) patients with DFU and 2) patients at risk of developing a diabetic foot problem. In these cohorts patients aged 18 years or older with a registration of either DFU or diabetic feet at risk between April 2004 and time of data extraction will be included. The date of first registration will define start of follow-up. All patients will be followed up for the occurrence of an LLA, date of transfer out of practice area, death, end of data collection, or end of risk period (1, 5, 10, or 15 years), whichever comes first.
Both traditional methods and machine learning techniques will be applied to develop and validate the prognostic scores.
Traditional: Regression models will be fitted with a predefined set of determinants for LLA, using forward selection with a significance level of 0.05. Various measures for prognostic accuracy including sensitivity, specificity, positive predictive values, negative predictive values, and beta-coefficients of the included factors will be determined. The beta-coefficients in the final Cox models will be converted into 1-, 5-, 10-, and 15-year absolute risk scores. The models performance will be determined by assessing goodness-of-fit and by assessment of the discriminative ability. To asses internal validity a k-fold cross-validation will be done.
Machine learning: The study population will be split into a `training' cohort and a Âtest cohort. The training cohort will be used to develop the prediction models using machine learning algorithms such as random forest (RF) and artificial neural networks (ANN). The models will be trained through 10-fold cross-validation. The test dataset will be used for model evaluation. Accuracy, sensitivity, specificity, receiver operating characteristics (ROC) curves and areas under the curve (AUC) will be determined.
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Validation of CPRD database transformed to Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) — Joe Maskell ...
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Validation of CPRD database transformed to Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-19
Organisations:
Joe Maskell - Chief Investigator - Amgen Ltd
Olga Archangelidi - Corresponding Applicant - Amgen Ltd
David Neasham - Collaborator - Amgen Ltd
George Kafatos - Collaborator - Amgen Ltd
Maurille Feudjo Tepie - Collaborator - Amgen LtdOutcomes:
Counts of rows in tables in OMOP and raw CPRD; estimates of lifetime point prevalence for diseases, prescriptions, lifestyle factors and tests; estimates of period prevalence for diseases, prescriptions, lifestyle factors and tests; estimates of incidence rates for diseases, prescriptions, lifestyle factors and tests
Description: Technical Summary
In order to validate the OMOP version of the database against the raw CPRD, the number of unique data rows will be compared between the raw CPRD data and the equivalent OMOP CDM-transformed CPRD data for the following tables: Practice, Patient, Clinical, Referral, Test, Therapy.
In addition, estimates of lifetime point prevalence, period prevalence and incidence rates will be produced. We will produce these rates in the raw and OMOP versions of the database for twenty diseases and thirteen therapies chosen for their relevance to Amgen's products and for two lifestyle factors (smoking status and BMI) and two lab results.We will produce two rates using the raw CPRD: Those that include information before a patient's observation start date (the greater of the UTS, up-to-standard date and the CRD, current-registration-date) and those that do not include this information. The standard version 4 of the OMOP CDM doesn't include the information before a patient's observation start date. We expect to show that the information prior to a patient's observation start date is necessary for calculating accurate incidence and prevalence rates and to show we get an exact match when we use the OMOP version of the database when this information is included.
No statistical tests will be carried out.
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Epidemiology of osteoarthritis and associated comorbidities: a combined case-control and cohort study — Weiya Zhang ...
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Epidemiology of osteoarthritis and associated comorbidities: a combined case-control and cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-11
Organisations:
Weiya Zhang - Chief Investigator - University of Nottingham
Subhashisa Swain - Corresponding Applicant - University of Nottingham
Aliya Sarmanova - Collaborator - University of Nottingham
Carol Coupland - Collaborator - University of Nottingham
Chang-Fu Kuo - Collaborator - University of Nottingham
Christian Mallen - Collaborator - Keele University
Michael Doherty - Collaborator - University of NottinghamOutcomes:
Primary outcome:
The primary outcome of the study will be the association between OA and a range of comorbidities. We are particularly interested in chronic widespread pain, cardio-vascular, metabolic/endocrine, respiratory, neurological, gastrointestinal, psychological, genito-urinary, neoplasm/cancer, skin and subcutaneous, behavioural and developmental problem, nutritional disorders, and sleep disorders. The full list of comorbidities is given in Appendix-3.Secondary outcomes:
The three secondary outcomes to be studied are:
i) the trends of age-sex standardized prevalence and incidence rates of OA in the UK between 1997 to 2017;
ii) the pattern and trajectories of clustering of comorbidities in OA, their burden in terms of Disability of Adjusted Life Years (DALYs) between clusters;
iii) frequency of hospitalization, prescription and all-cause mortality across the comorbidity cluster groupsDescription: Technical Summary
Osteoarthritis (OA) is a common chronic condition that has significant detrimental impact on daily activities and quality of life. There is lack of evidence on the association and/or causal relationship of OA with other chronic diseases (comorbidities) such as cardiovascular disease and diabetes. Presence of comorbidities affects management and outcome of OA in several ways. For example, some treatments (e.g. systemic analgesics) may add a further burden to the comorbidity, whereas others (e.g. exercise and weight loss) may benefit both OA and its comorbidities. This project aims to examine the trends, patterns and healthcare utilisation of OA and its comorbidities in the past 20 years in the UK using the Clinical Practice Research Data-link (CPRD). Hospital Episode Statistics (HES) will be used to determine hospitalisation. Office of National Statistics (ONS) death registration data will be used to map the death registration. Multiple deprivation index data will be used to explore the association with social factors. Trends of age-sex standardized incidence and prevalence of OA (and by body region) will be calculated for the last 20 years (1997-2017).
We will determine incident OA cases according to the first diagnosis date (index date) and match each case with a non-OA (control) by age, gender and practice on a 1:1 basis with the same index date being allocated. We will retrospectively review comorbidities diagnosed prior to the index date and follow up at-risk OA cases and matched controls for incident comorbidities after the index date. The clusters of comorbidities will be examined for differences in pattern, trajectories, health utilisation and mortality. For the retrospective study, conditional logistic regression will be used to estimate the odds ratios, and for the follow-up prospective study Cox-proportional hazard regression will be used to estimate the hazard ratios.
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Determining the optimal timing of triple therapy initiation in patients with chronic obstructive pulmonary disease (COPD) in the United Kingdom (UK): A retrospective, longitudinal cohort study — Afisi Ismaila ...
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Determining the optimal timing of triple therapy initiation in patients with chronic obstructive pulmonary disease (COPD) in the United Kingdom (UK): A retrospective, longitudinal cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-12
Organisations:
Afisi Ismaila - Chief Investigator - GSK
Robert Wood - Corresponding Applicant - Adelphi Real World
Daniel Bluff - Collaborator - Adelphi Real World
Glenn Anley - Collaborator - GSK
Leah Sansbury - Collaborator - GlaxoSmithKline - UK
Olivia Massey - Collaborator - Adelphi Real World
Stuart Blackburn - Collaborator - Adelphi Real World
Yein Nam - Collaborator - Adelphi Real WorldOutcomes:
All medications prescribed in primary care; COPD medications prescribed in primary care; All-cause GP appointments; COPD-related GP appointments; All-cause outpatient appointments; COPD-related outpatient appointments; All-cause hospitalisations; COPD-related hospitalisations; All-caused A&E visits; COPD-related A&E visits; Associated all-cause total direct healthcare costs; Associated COPD-related direct healthcare costs
Description: Technical Summary
Objectives: The primary objective of this study is to estimate all-cause and COPD-related healthcare resource utilisation (HCRU) and direct healthcare costs of patients with COPD initiating MITT early (</=30 days) versus delayed (31-180 days) following a moderate-to-severe exacerbation.
Methods: This study will be a retrospective, longitudinal cohort study of COPD patients who are initiated on MITT within 180 days of an exacerbation between July 2012 and June 2015, inclusive. The cohort of patients will be identified from the Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) data; specifically, the admitted patient care, outpatients and Accident & Emergency (A&E) data sets. Elements of HCRU that will be considered in this study include General Practitioner consultations, medication prescribed in primary care, outpatient appointments and hospitalisation, and the associated direct healthcare costs.
Data analysis: The study will be testing the hypothesis that patients who initiate MITT early utilise less HCRU and result in a lower cost to the healthcare system compared with patients with delayed MITT initiation. In addition, potential confounding factors will be adjusted for using regression models, and time-to-event analysis will be conducted to assess the influence of the delay of MITT initiation on future exacerbations.
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Bereavement amongst those with chronic kidney disease - does it affect outcomes? — Dorothea Nitsch ...
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Bereavement amongst those with chronic kidney disease - does it affect outcomes?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-13
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Christian Christiansen - Collaborator - Aarhus University Hospital
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sigrun Alba Johannesdottir Schmidt - Collaborator - Aarhus University Hospital
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Soren Vestergaard - Collaborator - Aarhus University Hospital
Yochai Schonmann - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Outcomes (ICD-10 code):
 First cardiovascular event after index date (myocardial infarction (I21), acute heart failure (I50), and stroke (I60, I61, I63, I64))
 First acute kidney injury after index date (N17)
 DeathOutcomes will derive from International Classification of Diseases (ICD) 10th revision codes recorded in the Hospital Episode Statistics (HES) dataset. We will identify dates of death using Office of National Statistics (ONS) data for those who had linkage to ONS and CPRD derived dates of death for those without linkage to ONS. Preliminary code lists for the outcomes are provided in the appendix. All outcomes will be identified in the cohort following the index date for both the exposed and unexposed groups, with each participant capable of contributing more than one outcome before censorship. For example, a participant may experience acute kidney injury, and then go on to experience stroke one month later. This participant would add to the event count of both outcomes in the analysis. We will only be considering the first outcome event after the index date; we will not be investigating repeat events of the same outcome during follow-up. Prevalent cardiovascular and kidney disease will be adjusted for in the adjusted regression models (see section N).
Each participant will be followed until one of the following: death, transfer out of the general practice (including for either member of the couple in the non-bereaved group), or the end of the observation period available (currently 31 July 2018).
Description: Technical Summary
Bereavement is a known risk factor for a variety of poor cardiovascular outcomes and death. To our knowledge, there are no studies which have assessed the impact partner bereavement may have on cardiovascular and kidney outcomes specifically in patients with pre-existing chronic kidney disease (CKD). This study will be designed as a matched historical cohort study to investigate a possible association between partner bereavement and an increased risk of cardiovascular events, acute kidney injury, and death in people with CKD. This study will use primary care data from the Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) data to determine exposure, outcome, and confounder statuses in our study population. Partners will be identified in the CPRD using the family number and restricted to those with CKD, whilst maintaining de-identification of individual patient data. The exposure of interest is partner bereavement in patients with CKD. Each bereaved (exposed) individual will then be matched with up to 10 other people with CKD based on age, sex, and general practice. Matched unexposed patients must be alive at the exposed person's index date of bereavement but have never experienced partner bereavement before the index date. Time-to-event analyses (either Poisson or Cox models, depending on the shape of the relative hazards over time) will be used to investigate crude and adjusted associations of bereavement with CVD outcomes, AKI, and death. Crude and adjusted hazard ratios and 95% confidence intervals will be used to measure any possible associations between bereavement and adverse outcomes in the study population.
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A personalized approach to depression care: Discovering adaptive treatment strategies — Samy Suissa ...
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A personalized approach to depression care: Discovering adaptive treatment strategies
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-07
Organisations:
Samy Suissa - Chief Investigator - McGill University
Erica Moodie - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Janie Coulombe - Collaborator - McGill UniversityOutcomes:
Primary outcome: Composite of self-harm, suicide attempt, hospitalization for depression;
Secondary outcome: BMIDescription: Technical Summary
People experiencing depression and those who care for them are often faced with many treatment options and insufficient information for how to choose the best treatment. This research project proposes to discover adaptive treatment strategies (ATSs) that tailor treatment decisions to patient characteristics such as demographic characteristics, comorbidities, and response to previous treatments. The aims of this retrospective cohort study are to (1) estimate a tailored pharmaco-therapeutic treatment strategy for depression that adapts to patient-specific variables, and (2) compare the estimated strategy with one derived from the Mental Health Research Network, which includes longitudinal, patient-reported depression symptoms but is less representative sample to assess the validity and generalizability of the latter sample.
The analyses for aims (1) and (2) will estimate the ATS that reduces the risk of treatment failure, defined as the composite of self-harm, suicide, or hospitalization for depression. First-line treatments considered will be an antidepressant that is either a selective serotonin reuptake inhibitor, a third-generation antidepressant, or a tricyclic. For individuals not responding to the initial treatment, second-line treatments considered will be switching to a different medication in the same class, or in a different class. Estimation will be by Q-learning and its more robust counterpart, dynamic weighted ordinary least squares.
To undertake aim (2), comparisons between estimated rules will be taken both qualitatively (examining whether the same tailoring variables are used in both cohorts, evaluating the similarity of treatment decision thresholds) and quantitatively, by simple statistical metrics such as Cochran's Q test, a non-parametric test of concordance to assess whether the recommended treatments from each estimated rule differs within the sample. Our work will serve to identify patient characteristics that can be used to tailor therapies so that patients receive the treatments most likely confer the greatest benefit.
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Data analysis of the current treatments for major depressive disorder and treatment resistant depression in the United Kingdom — Tom Denee ...
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Data analysis of the current treatments for major depressive disorder and treatment resistant depression in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-18
Organisations:
Tom Denee - Chief Investigator - Janssen Pharmaceuticals UK
Robert Wood - Corresponding Applicant - Adelphi Real World
Chloe Middleton - Collaborator - Adelphi Real World
Cicely Kerr - Collaborator - Janssen Pharmaceuticals UK
Gemma Scott - Collaborator - Janssen Pharmaceuticals UK
John Waller - Collaborator - Adelphi Real World
Laleh Safinia - Collaborator - Janssen Pharmaceuticals UK
Mitesh Desai - Collaborator - Janssen Pharmaceuticals UK
Olivia Massey - Collaborator - Adelphi Real World
Rishender Singh - Collaborator - Janssen Pharmaceuticals UK
Stuart Blackburn - Collaborator - Adelphi Real World
Theo Tritton - Collaborator - Adelphi Real WorldOutcomes:
Incidence of MDD; Incidence of TRD; Treatment patterns (treatments prescribed, dose prescribed, treatment dynamics and number of lines of therapy received); Baseline demographics (age, sex, region, ethnicity); Clinical characteristics (number of episodes, episode type, TRD diagnosis and comorbidities); Treatment outcomes (relapse, recovery, recurrence, remission and response); Hospitalisations (length of stay, intensive care required).
Description: Technical Summary
This study aims to better understand the epidemiology and pharmacoeconomics of MDD and TRD, and the current treatment pathways used in the treatment of these conditions in the UK, which will in turn allow Janssen to ascertain whether there is a specific unmet need within these patient groups regarding the treatment options currently available, and thus highlighting the need for new treatments. The results of this study will also be used to inform a submission to a UK Health Technology Assessment (HTA) body to determine the relevance of currently-available comparators.
Methods:
To address the study objectives, a retrospective, longitudinal cohort design will be employed in incident MDD patients identified between January 2011 and May 2015 using linked CPRD-HES-MHDS data. Patients will be indexed on the date of first AD prescription within the indexing period and all indexed patients will be followed up for a minimum of 180 days, with the exception of those who die in the 180 days following indexing. Linked CPRD-HES data will be used to address all objectives. Linked CPRD-HES data will be used in conjunction with MHDS data to describe the use of non-pharmacological treatments.
Data analysis:
All analyses will be predominantly descriptive in nature, with all outcomes reported using appropriate descriptive statistics. Statistical testing will be utilised between subgroups, where applicable, in addition to Kaplan-Meier estimates (for time-to-event analyses) and generalised linear models (for regression modelling). Analyses pertaining to the primary and secondary objectives will include estimation of incidence of MDD and TRD, description of treatment pathways and treatment outcomes at each line of therapy and description of baseline demographics and clinical characteristics. Unit costs will be derived from secondary care data using Healthcare Resource Groups (HRGs), and from primary care through imputation from appropriate sources.
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Juvenile Idiopathic Arthritis (JIA): occurrence, comorbidity and healthcare utilisation — Jenny Humphreys ...
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Juvenile Idiopathic Arthritis (JIA): occurrence, comorbidity and healthcare utilisation
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-19
Organisations:
Jenny Humphreys - Chief Investigator - University of Manchester
Ruth Costello - Corresponding Applicant - University of Manchester
Janet McDonagh - Collaborator - University of Manchester
Kimme Hyrich - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of Manchester
Richard Beesley - Collaborator - University of Manchester
William Dixon - Collaborator - University of Manchester
Yvonne Tan - Collaborator - University of ManchesterOutcomes:
Occurrence of JIA
- All-cause mortality
- Hospital admission for uveitis
- Hospital admission for infection
- Hospital admission for cancer.
- Pregnancy and birth rates for mothers with JIA and neonatal morbidity in their children.Description: Technical Summary
This study aims to establish the overall burden of juvenile idiopathic arthritis (JIA) in the UK. The primary aim is to report the incidence, prevalence and persistence of JIA into adulthood. Secondary objectives will investigate associations between JIA and mortality, comorbidities and healthcare utilisation.
JIA is an umbrella term for subtypes of inflammatory arthritis diagnosed prior to age 16. Classification criteria have changed over time; consequently, incidence and prevalence rates vary significantly. The only UK estimates come from 1996, prior to international consensus on classification and are therefore outdated. With the emergence of high cost drugs to treat JIA, accurate estimates are essential for appropriate health service planning and resource allocation. Alongside this, accurate data JIA disease burden are urgently required, including mortality risk, occurrence of important comorbidities such as uveitis, cancer and infections, and healthcare utilisation.
Cases of JIA will be identified using Read codes. Annual incidence and prevalence rates will be estimated along with standardised mortality ratios. Poisson regression will be used to determine incidence rates stratified by age, gender, subtype, socioeconomic status and region of the UK, and rates of healthcare utilisation compared to a matched healthy control cohort. In a subset hospital episodes statistics data will be used to validate the JIA case definition and to identify the proportion of young people with JIA that go on to use adult rheumatology services. The risk of mortality and comorbidities in patients with JIA compared to controls will be assessed using multivariable Cox proportional hazards regression model.
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Risk of non-melanoma skin cancer among hypertensive adults in the United Kingdom treated with angiotensin converting enzyme inhibitors: a population based, active comparator, new user, retrospective cohort study — Laurie Tomlinson ...
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Risk of non-melanoma skin cancer among hypertensive adults in the United Kingdom treated with angiotensin converting enzyme inhibitors: a population based, active comparator, new user, retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-29
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rhea Fitzgerald - Corresponding Applicant - Trinity College Dublin
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah-Jo Sinnott - Collaborator - Not from an Organisation
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
First diagnosis of cutaneous squamous cell cancer (cSCC), first diagnosis of basal cell cancer (BCC)
Description: Technical Summary
In 2018, the European regulator issued warnings to prescribers that hydrochlorothiazide (HCTZ), a photosensitiser used to treat hypertension and heart failure, may increase the risk of non-melanoma skin cancer (NMSC). An important risk factor for NMSC is ultraviolet light, and although its incidence demonstrates geographic variation, it is particularly common among Caucasians. Angiotensin converting enzyme inhibitors (ACEi) are recommended in the UK as first line therapy for hypertension in Caucasian subjects under the age of 55. Photosensitivity is an adverse reaction to ACEi, for example estimated to occur in more than 1 in 1000 but less than 1 in 100 with perindopril. Studies to date on the association between ACEi and NMSC are conflicting, and none have been conducted in the UK. In most, the reference group has been non-exposure, with potential for confounding by indication. Most have not adjusted for use of HCTZ. HCTZ is frequently prescribed with ACEi, but studies to date have not investigated the potential for effect modification by HCTZ.
We propose a population-based, historical cohort study to determine the risk of NMSC among new users of ACE-I as compared to new users of calcium channel blockers (CCB) for the treatment of hypertension in adults in the UK. Primary objective is to determine whether the risk of first cSCC and of first BCC is greater among adults with hypertension exposed to an ACEi compared to those exposed to a CCB. As secondary objectives, the study will evaluate whether there is effect modification by exposure to HCTZ and by ethnicity. Strength of association will be measured using hazards ratios, after multivariable adjustment with Cox proportional hazards regression.
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A matched population-based case control study to determine which clinical features are associated with the inherited cardiac conditions, bicuspid aortic valve and long QT syndrome in primary care — Nadeem Qureshi ...
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A matched population-based case control study to determine which clinical features are associated with the inherited cardiac conditions, bicuspid aortic valve and long QT syndrome in primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-11
Organisations:
Nadeem Qureshi - Chief Investigator - University of Nottingham
William Evans - Corresponding Applicant - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of NottinghamOutcomes:
The recognition of phenotypic features identified in primary care that can indicate such a diagnosis. This could then be used to inform guidance, alert clinicians and develop diagnostic prompts for these conditions.
Description: Technical Summary
Background: Both bicuspid aortic valve (BAV) and long QT syndrome (LQTS) are associated with significant morbidity and mortality and are under recognised. Bicuspid aortic valve disease affects 0.5-2% of the population and is associated with greater morbidity and mortality across the population than all other congenital heart defects combined. Long QT syndrome affects 1 in 2000-3000, and is a significant cause of avoidable sudden cardiac death.
Objectives: To explore the feasibility that primary care electronic patient records (EPR) can identify patterns as well as gaps in clinical coding for patients with under recognized inherited disorders, as exemplars of this we will look at the inherited cardiac conditions: bicuspid aortic valves and long QT syndrome.
Study Design: For each of the conditions, BAV & LQTS.
- Part 1: Exploratory analysis to identify signals using Machine-Learning (Random Forest (RF) model method).
- Part 2: Case control design to verify/test variables that have been identified in part 1.Setting: UK General Practice
Participants: Individuals identified with LQTS and BAV diagnosed in their EPR compared with propensity scored matched controls.
Exposures: As this is a matched case-control study, identification of the exposures is the result of the study. These are the clinical features identified in primary care that can indicate such a diagnosis.
Comparator: Propensity scored matched control group.
Outputs: Those diagnosed with BAV and LQTS by Read code in the EPR.
The identification of these ÂexposuresÂ, clinical features, could then be used to inform guidance, alert clinicians and develop diagnostic prompts for these conditions.
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Database - Prescription Event Monitoring (D-PEM) study to identify, quantify and characterise identified adverse events associated with the use of a widely prescribed medication in primary care in the UK — Saad Shakir ...
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Database - Prescription Event Monitoring (D-PEM) study to identify, quantify and characterise identified adverse events associated with the use of a widely prescribed medication in primary care in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-12
Organisations:
Saad Shakir - Chief Investigator - Drug Safety Research Unit
Debabrata Roy - Corresponding Applicant - Drug Safety Research Unit
Catherine Fry - Collaborator - Drug Safety Research Unit
Elizabeth Lynn - Collaborator - Drug Safety Research UnitOutcomes:
 Reasons for consultations during primary care treatment
 Dose and duration of treatment
 Demographics of patients using alendronic acid (70mg once weekly)
 Prior medical history (reasons for consultations)Description: Technical Summary
This cohort study will assess whether specific identified safety risks associated with the use of a medication, widely prescribed in primary care, can be identified in a primary care EHR database.
Patients will be identified from the CPRD GOLD database and the study conducted using the Database - Prescription Event Monitoring (D-PEM) methodology. The method of Prescription Event Monitoring (PEM) is well described and has been used for many years (1, 2). The PEM methodology in the UK was developed by the Drug Safety Research Unit and is a paper based method used to identify patients from prescriptions and detect safety signals from clinical event records.
The purpose of this study is to examine whether using EHR database such as CPRD is feasible for conducting event monitoring and whether such use adds value to study methods in pharmacoepidemiology and pharmacovigilance and assess any problems or difficulties that may arise.
Alendronic acid (once weekly 70mg dose) has been identified as the study drug. Patients will be identified who have been prescribed alendronic acid (between 2000 and 2003) and safety events on treatment identified within a 12 month observation period.
Categorical data will be presented as tabulations; continuous data will be described using appropriate summary statistics. Reasons for consultations will be tabulated using grouping based on clinical code levels to allow for patterns to be identified and quantified as individual recording variation may preclude signal detection.
Incidence risks and density calculations will be performed for safety events of interest. Incidence densities will be compared between time periods to allow for comparisons between: i) pre- and post-treatment exposure periods; ii) treatment exposure periods.
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Validation of a Risk Estimation Algorithm for Predicting the Early Risk of Chronic Kidney Disease in Newly Diagnosed Diabetics Based on General Practitioners Records in the United Kingdom — Tony Huschto ...
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Validation of a Risk Estimation Algorithm for Predicting the Early Risk of Chronic Kidney Disease in Newly Diagnosed Diabetics Based on General Practitioners Records in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-19
Organisations:
Tony Huschto - Chief Investigator - Roche
Tony Huschto - Corresponding Applicant - Roche
Christian Ringemann - Collaborator - Roche
Claire Marriott - Collaborator - Roche
Helena Konig - Collaborator - RocheOutcomes:
Overall Performance of the prediction algorithm for newly diagnosed diabetes patients on the unrestricted cohort and the relevant sub-cohorts;
Comparison with literature algorithms;
Gender-specific and diabetes type-specific performance of the prediction algorithm;
Analysis of the feature importance of different clinical markers for the prediction of CKD.Description: Technical Summary
This is a retrospective cohort study using secondary data. People with diabetes mellitus (PwD) with and without the comorbidity of chronic kidney disease (CKD) will be filtered from the CPRD data set based on pre-selected READ codes (code lists provided in Appendix A). Baseline characteristics will be described for all included patients. The relevant laboratory covariates will be extracted from the patientÂs records using the corresponding READ Codes (see Appendix B). The performance of a previously developed multivariate logistic regression algorithm for accurately predicting the risk of developing CKD within three years after the initial diabetes diagnosis will be compared against a selection of published benchmark algorithms developed using data from clinical trials. The comparison will be conducted both for the unrestricted real-world patient cohort (of PwD with and without a CKD comorbidity) and for sub-cohorts created according to criteria closely mimicking the clinical trial setting those algorithms were built from. The prediction performance will be primarily measured by the area under the receiver operating characteristics curve (AUC) of each algorithm as it was done for the original research. However, to obtain further insight into the algorithmÂs performance we determine complete ROC curves, providing straightforward calculations of additional performance metrics. We will discuss illustrative pairs of sensitivity and specificity in our analysis.
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Assessment of off-label use of baricitinib in the paediatric population in the United Kingdom — Krista Schroeder ...
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Assessment of off-label use of baricitinib in the paediatric population in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-26
Organisations:
Krista Schroeder - Chief Investigator - Eli Lilly & Co Ltd - US Headquarters
Krista Schroeder - Corresponding Applicant - Eli Lilly & Co Ltd - US Headquarters
Claudia Salinas - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Jonathan Swain - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Kristin Meyers - Collaborator - Eli Lilly & Co Ltd - US HeadquartersOutcomes:
 Age at baricitinib prescription (primary)
 Gender (secondary)
 Region (secondary)
 Baseline/pre-index diagnoses (secondary)Description: Technical Summary
Baricitinib is approved in the United Kingdom (UK) for the treatment of rheumatoid arthritis (RA) and atopic dermatitis (AD) in adults. Baricitinib has not yet been studied in children and adolescents and hence its use in this population is classified as a safety concern (missing information) in the Risk Management Plan for baricitinib. Lilly has proposed this study in order to provide a more systematic evaluation of use in children and adolescents in the UK. Understanding the proportion of baricitinib prescribing that is off-label to children and adolescent will help quantitate the level of this safety concern.
Using a descriptive cohort design, subjects within the Clinical Practice Research Datalink (CPRD) database that receive at least one prescription for baricitinib from April-2017 to June-2022 will be recruited into the study and indexed on the date of their first CPRD recorded baricitinib prescription during the timeframe. Using this cohort, this study will evaluate the proportion of baricitinib prescribing that occurs off-label to paediatric patients (less than 18 years of age at index). If paediatric prescribing is found, this study will further describe paediatric patients who receive a prescription for baricitinib in terms of demographics (age, gender) and diagnoses received during the 1-year before receipt of baricitinib.
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Delayed treatment intensification and risk of micro- and macrovascular complications in insulin-treated patients with type 2 diabetes; a United Kingdom Clinical Practice Research Datalink Retrospective Cohort Study — Samuel Seidu ...
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Delayed treatment intensification and risk of micro- and macrovascular complications in insulin-treated patients with type 2 diabetes; a United Kingdom Clinical Practice Research Datalink Retrospective Cohort Study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-03-13
Organisations:
Samuel Seidu - Chief Investigator - Leicester Diabetes Centre
Sharmin Shabnam - Corresponding Applicant - Leicester Diabetes Centre
Clare Gillies - Collaborator - University of Leicester
David Webb - Collaborator - Leicester Diabetes Centre
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Sophia Abner - Collaborator - University of LeicesterOutcomes:
 Macrovascular endpoints: The occurrence of the first (new onset) major CV event (MI, stroke, CABG, PTCA, amputation, new or worsening HF, death from CV events).
 Microvascular endpoints (Retinopathy): New onset retinopathy or progression entered onto patient record after BI initiation.
 Microvascular endpoints (Nephropathy): Decline in renal function (doubling of serum creatinine, eGFR decline more than 5% yearly, ESRD; eGFR ?15 ml/min/1.73 m2 or renal replacement therapy).
 Composite Microvascular endpoints: occurrence of the first retinopathy or nephropathy event.
 First occurrence of composite of microvascular or macrovascular endpoint.
 Health resource use for each of the three sub-groups will be quantified (including prescribed medications, and annual rates of primary care consultations and outpatient clinics visits).For those patients in home persistence to insulin did not occur
 Mean duration of basal insulin persistence
 HbA1c after 6 months post initiation of new antidiabetic therapy when the basal insulin regime stopped.
 Weight after 6 months post initiation of new antidiabetic therapy when the basal insulin regime stopped.Description: Technical Summary
A number of observational studies in type 2 diabetes patients (T2DM) have reported that insulin initiation is delayed until after multiple oral antidiabetic drug (OAD) failure and deterioration of glycaemic control well beyond recommended guidelines. Such delay in treatment intensification is even more evident after basal insulin (BI) initiation. In a retrospective cohort study of UK Clinical Practice Research Datalink (CPRD), only 30.9% of T2DM patients clinically eligible for intensification received additional treatment, with a median time to intensification of 3.7 years (95% CI 3.4 to 4.0).
The delay in treatment intensification in patients with poor glycaemic control (clinical inertia) has long-lasting effects on micro- and macrovascular complications of T2DM and has been referred to as "negative metabolic memory" also known as dysglycaemic legacy. In line with this notion, a 1 year delay in treatment intensification in patients with suboptimal glycaemic control on OADs is associated with increased risk of major adverse cardiovascular outcomes including myocardial infarction, heart failure and stroke. However, the consequence of delayed treatment intensification and suboptimal glycaemic control in BI treated T2DM patients in a real world setting have not been previously investigated. It is unclear what proportions of patients who do not persist on their basal insulin therapies move onto the various classes of antidiabetic drugs and what the trajectory of HbA1c control is thereof.
Thus, we aimed to investigate the associations of delayed treatment intensification and long-lasting hyperglycaemia with micro- and macro-vascular outcomes after BI initiation in T2DM patients using UK CPRD. This will be determined using time-to-event survival analysis using cox-proportional regression model (adjusting for time-dependent and time-independent covariates). Additionally, we will assess the duration of persistence for basal insulin therapies in people with type 2 diabetes, taking into consideration the various predictors of persistence and the type of insulin. We will also asses what drugs they move onto following non-persistence to basal insulin, and the mean change in HbA1c after 6 months.
Source
2019 - 02
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Risks of antidepressants on cardiovascular mortality and morbidity, suicidality, falls and fractures in people with obesity and depression in primary care — Richard Morriss ...
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Risks of antidepressants on cardiovascular mortality and morbidity, suicidality, falls and fractures in people with obesity and depression in primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-08
Organisations:
Richard Morriss - Chief Investigator - University of Nottingham
Richard Morriss - Corresponding Applicant - University of Nottingham
Francesco Zaccardi - Collaborator - University of Leicester
Freya Tyrer - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of LeicesterOutcomes:
 Cardiovascular disease and mortality (See Appendix 2)
 All-cause mortality
 Suicidality/Self-harm (See Appendix 2)
 Diabetes mellitus (See Appendix 2)
 Fractures/Falls (See Appendix 3)Description: Technical Summary
In population cohort studies using primary care records linked to hospital episode statistics and records of deaths, selective serotonin reuptake inhibitor, tricyclic and other antidepressants show differences in serious outcomes such as suicide, fractures and mortality. People with obesity are more likely to have depression and to be prescribed antidepressants than other people. Cohort studies show that antidepressants vary in relation to weight gain so it is possible that they might have different risks for cardiovascular mortality and diabetes outcomes as well.
Using CPRD linked to hospital episode statistics and mortality records, we will determine the relative risk of the most commonly prescribed antidepressants and antidepressant classes on serious outcomes related to cardiovascular health, mortality, diabetes and suicidality in people with first episode depression who were previously found to be overweight or obese. We will use Cox proportional hazards modelling to assess the effect of individual antidepressants and classes of antidepressants on the serious outcomes. We will control for confounding variables such as smoking, alcohol intake, other prescribed medication, other physical and mental health diagnostic comorbidities known to be associated with cardiovascular outcomes, mortality and depression outcomes.
We will co-produce the presentation of our results with patients and public representatives to be informative to patients and prescribers alike.
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The association between fracture risk and diabetes duration, complications and regulation in diabetes mellitus — Frank de Vries ...
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The association between fracture risk and diabetes duration, complications and regulation in diabetes mellitus
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-22
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Cindy Sarodnik - Collaborator - Maastricht University
Johanna Driessen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Morten Jensen - Collaborator - Aalborg University Hospital
Nicklas Rasmussen - Collaborator - Aalborg University Hospital
Nicolaas Schaper - Collaborator - Maastricht University
Patrick Souverein - Collaborator - Utrecht University
Peter Vestergaard - Collaborator - Aalborg University Hospital
Sandrine Bours - Collaborator - Maastricht UniversityOutcomes:
1.     Risk factors for fracture risk in patients with T1DM or T2DM compared to healthy matched controls, broken down by fracture type.
- The association of diabetes duration, quality of glycaemic control and microvascular complications with fracture risk in patients with T1DM or T2DM.
- The association of diabetes duration with fracture risk in T1DM or T2DM, stratified for quality of glycaemic control and the presence of microvascular complications.Description: Technical Summary
The objective of this study is to determine whether fracture risk is increased in patients with diabetes mellitus (DM) compared to matched controls, broken down by fracture type and to identify risk factors per fracture type. In addition, we will investigate diabetes specific risk factors within patients with DM.
The study population will consist of all patients with diabetes within the full CPRD cohort. Diabetes will be identified by a prescription for an insulin, or a non-insulin anti-diabetic drug (NIAD). The date of the prescription will define the index date. In order to identify incident diabetics, patients will need to have at least one year of valid data collection before the index date. Patients with diabetes will be matched by year of birth, sex and practice to 1 control patient without diabetes, using incidence density sampling. Control patients will be assigned the index date of their matched control. The study period for this study will be 1987 - 2017.
Cox regression will be used to compare fracture risk in patients with DM (T1DM/T2DM) to healthy controls. For each fracture type we will investigate what potential risk factors are. We identified these possible risk factors based on literature and we will use them as potential confounders. We will also do this for T1DM and T2DM separately. Within the DM cohort we will investigate whether regulation of DM, presence of complications and duration of DM are specific risk factors for the different fracture types.
For aim 1 the following confounders are considered:
Age, Charlson comorbidity index, A history of: fall and hypoglycaemia related hospitalizations and use of the following drugs in de 6 months before an interval:
anti-epileptics, oral glucocorticoids, antidepressants, anxiolytics or hypnotics, antipsychotics,
anti-Parkinson drugs, opposed hormone replacement therapy, calcium, bisphosphonates, vitamin D, raloxifene, strontium ranelate, calcitonin, and parathyroid hormone.For aim 2+3 main confounders are, depending on the outcome, DM duration, DM regulation or presence of microvascular complications. Other confounders are antidiabetic medication, other medication, educational level, Anti-depressive use and history of cardiovascular disease.
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Characteristics of patients initiating Spiriva Respimat in Asthma in the UK: a cross-sectional study based on the Clinical Practice Research Datalink — Jennifer Quint ...
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Characteristics of patients initiating Spiriva Respimat in Asthma in the UK: a cross-sectional study based on the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-21
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Qiang Li - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Alicia Gayle - Collaborator - Imperial College London
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
Laura Wallace - Collaborator - Boehringer-Ingelheim International GmbHOutcomes:
The primary outcome is whether patient has Cardiac arrhythmias on the index date or in the year prior to the index date.
The secondary outcome is whether patient has Cardiac failure on the index date or in the year prior to the index date.Description: Technical Summary
Spiriva Respimat (tiotropium) is a long acting anticholinergic bronchodilator. In the UK, Spiriva Respimat is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year.
Spiriva Respimat was approved for the treatment of asthma in late 2014 in the UK. Until now it is not clear whether patients initiating Spiriva Respimat are different in demographic and clinical characteristics from patients receiving other available treatments. This cross-sectional, non-interventional study will use the UK CPRD data to describe the characteristics of patients who initiate Spiriva Respimat for the treatment of asthma, and compare them with asthma patients who initiate a higher dose of ICS/LABA FDC, or LTRA, or alternatively those who switch to a new ICS/LABA FDC. This type of study will allow us to evaluate potential channeling of prescribing to different patient populations.
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Use of Sodium-glucose co-transporter-2 inhibitors, changes in body mass index and risk of major osteoporotic fracture — Frank de Vries ...
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Use of Sodium-glucose co-transporter-2 inhibitors, changes in body mass index and risk of major osteoporotic fracture
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-12
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Bernardette Rossi - Collaborator - Maastricht University Medical Centre
Coen Stehouwer - Collaborator - Maastricht University
Johanna Driessen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Judith van Dalem - Collaborator - Utrecht University
Martijn Brouwers - Collaborator - Maastricht University
Nicklas Rasmussen - Collaborator - Aalborg University Hospital
Nikki Werkman - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Peter Vestergaard - Collaborator - Aalborg University Hospital
Richard Eastell - Collaborator - University of SheffieldOutcomes:
Primary: Major osteoporotic
fracture
Secondary: Hip, radius/ulna, clinical symptomatic vertebral fractureDescription: Technical Summary
The objective of this study is to evaluate the association between current use of SGLT-2 inhibitors and fracture risk as compared to current sulphonylurea (SU) use. In addition, we will investigate what the effect of change in BMI is on this association.
We will first create a base study population including all patients who start with metformin only during 1-1-98 and 30-6-2018. From this base population we will select all patients with a first ever prescription of a sulphonylurea (SU), SGLT-2-inhibitor or dipeptidyl peptidase 4 inhibitor (DPP4-I) prescription during 1-1-2013 and 30-6-2018. SU use will be the reference group. In addition, we will compare fracture risk between SGLT-2-I use and DPP4-I use. Exposure will be assessed time-dependently, with groups distinguishing between current, and past use. Cox proportional hazard models will be used to derive hazard ratios for the association between use of SGLT-2-Is and fracture risk. These models will be adjusted for potential confounders.
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Progression rates and risk factors for type 2 diabetes and cardiovascular disease in individuals diagnosed with gestational diabetes mellitus: A retrospective cohort study using CPRD — Clare Gillies ...
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Progression rates and risk factors for type 2 diabetes and cardiovascular disease in individuals diagnosed with gestational diabetes mellitus: A retrospective cohort study using CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-28
Organisations:
Clare Gillies - Chief Investigator - University of Leicester
Clare Gillies - Corresponding Applicant - University of Leicester
Bee Tan - Collaborator - University of Leicester
Elpida Vounzoulaki - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of LeicesterOutcomes:
Outcomes of interest are T2DM, CVD, and all-cause mortality.
Description: Technical Summary
Gestational diabetes mellitus (GDM) is a serious complication of pregnancy that affected an estimated 11% of pregnancies in Europe in 2013.[1] Although the condition is usually resolved naturally after birth, women who have previously suffered from GDM have an increased risk of progressing to type 2 diabetes (T2DM) and cardiovascular disease (CVD) in the future.
This work seeks to assess both incidence and risk factors for T2DM, CVD and cancer, after a diagnosis of GDM, in a cohort of women included within the Clinical Practice Research Datalink (CPRD). CPRD data (linked to both HES and ONS) will be used to examine progression rates to T2DM, CVD and cancer. Data will be extracted between 2000 and 2018, on women diagnosed with GDM who have at least 5 years of follow-up. For each case of GDM identified, a time-matched control with no diagnosis of GDM during pregnancy will be selected. The controls will be selected to ensure the pregnancy occurred within a year of the matched case. Further, within the GDM cohort, risk factors for progression to T2DM, CVD and cancer following GDM will be investigated (such as age, ethnicity, and weight), as well as any changes to progression rates from GDM to T2DM, CVD and cancer over time
All of this information, as well as further published information on health care costs, will be used to create a Markov model to assess the long-term health outcomes and cost implications of GDM in a UK population. This project will allow for a greater understanding of current progression rates to T2DM and cardiovascular events in women who have been diagnosed with GDM. Increasing understanding, particularly in terms of risk factors, will enable appropriate interventions to be developed, and for them to be targeted where they are most needed.
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The impact of musculoskeletal conditions on outcome of hospital care for acute coronary syndrome and stroke: a linked electronic health record study — John Edwards ...
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The impact of musculoskeletal conditions on outcome of hospital care for acute coronary syndrome and stroke: a linked electronic health record study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-21
Organisations:
John Edwards - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Alyson Huntley - Collaborator - University of Bristol
Christian Mallen - Collaborator - Keele University
Felix Achana - Collaborator - University of Oxford
James Bailey - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Stephen Tatton - Collaborator - Keele University
Ying Chen - Collaborator - Keele UniversityOutcomes:
1: Mortality (during hospitalisation, within 30 days of discharge)
2: Length of stay in hospital
3: Discharge location after hospitalisation (home, nursing home)
4: Readmission to hospital for any problem within 30 days of discharge.We will also determine the frequency of recorded musculoskeletal pain during hospitalisation or in primary care within 30 days following discharge.
Description: Technical Summary
The NHS is under pressure with increased rates of hospital admission and delayed transfer of care. In people with other long-term conditions, such as vascular disease, musculoskeletal pain is common but often neglected. Musculoskeletal comorbidity can impact on outcomes if pain, and associated restricted functioning and sleep interference, prevent or delay delivery of appropriate treatment or reduce its effectiveness. It may limit patients' ability to manage another condition at home, extending time to discharge, and worsening outcomes of these other conditions.
The extent to which outcomes from vascular disease are worse for people with pre-existing musculoskeletal conditions in the UK is unknown, although there is some international evidence of worse outcomes after stroke. We aim to understand the extent of association between pre-existing musculoskeletal conditions and outcomes for patients hospitalised for acute coronary syndrome (ACS) or stroke. We will analyse data of patients newly diagnosed with ACS or stroke and compare patients with a prior painful musculoskeletal condition requiring health care to patients without such a condition on mortality, length of hospital stay, discharge location, 30-day readmission for any condition, and resource use and costs. Painful musculoskeletal conditions will be identified from primary and secondary care records in the 24-months prior to ACS or stroke. We will compare outcomes of hospitalisation (mortality, discharge location, readmission) between those with and those without musculoskeletal comorbidity using binary logistic regression. Poisson regression will be used to determine differences in length of stay in hospital. We will include in further models proxies for severity (musculoskeletal referral, analgesia prescription). We will use mixed-effects models to account for clustering by practice. Our findings will allow assessment of the potential for existing evidence-based management of musculoskeletal pain and associated disability to be targeted in these patients to make a substantial impact on outcomes of ACS and stroke.
Source -
Type 2 Diabetes in women after a diagnosis of gestational diabetes: understanding uptake to screening and progression rates- a retrospective cohort study in the CPRD database — Kamlesh Khunti ...
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Type 2 Diabetes in women after a diagnosis of gestational diabetes: understanding uptake to screening and progression rates- a retrospective cohort study in the CPRD database
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-05
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Elpida Vounzoulaki - Corresponding Applicant - University of Leicester
Bee Tan - Collaborator - University of Leicester
Clare Gillies - Collaborator - University of LeicesterOutcomes:
 Post-partum screening rates following GDM; defined as any glucose testing within 6 months of delivery.
 Rates of uptake to annual screening following GDM, and whether these are changing over time
 Association of uptake to post-partum and annual screening with possible determinants such as age at diagnosis, time since diagnosis, ethnicity, pregnancy outcome, previous pregnancies, mode of delivery, pregnancy complications, ethnicity, smoking status, alcohol intake, deprivation index, BMI, mental health and geographic area.
 Progression to T2DM based on the type of screening test performed (fasting plasma glucose test, HbA1c test or OGTT)
 Long-term cardiovascular and mortality outcomes in women who attended post-partum and annual screening compared to those who did not.Description: Technical Summary
This study aims to estimate the proportion of women who attend post-partum follow-up and annual screening and recognise potential key factors that have an impact on these rates. The cohort will include patients with no previous diagnosis of T1DM or T2DM, diagnosed with GDM between 01/01/2000 and 05/11/2018 and having at least 12 months of follow-up. Previous research indicates that GDM is underreported in primary care and using linked primary-secondary care data will add a significant number of GDM cases to our cohort. Evaluation of screening rates and factors associated with them will be investigated in our cohort. In cases where women have GDM in multiple pregnancies, the first pregnancy complicated by occurrence will be used as the index pregnancy. Post-partum follow-up will be defined as any recorded glucose testing within 6 months of delivery. Determinants of screening uptake such as age, time since diagnosis, ethnicity, pregnancy outcome, previous pregnancies, delivery mode, pregnancy complications, ethnicity, smoking status, alcohol intake, deprivation index, body mass index (BMI), mental health and geographic area will be extracted based on the information available within CPRD-HES data. Additionally, we will investigate progression to T2DM based on the type of screening test performed (fasting plasma glucose, HbA1c or oral glucose tolerance test (OGTT)) and long-term cardiovascular and mortality outcomes in women who attended screening compared to those who did not. We will use multivariate logistic regression models to estimate the association of several factors to screening uptake and missing data will be addressed through complete-case analysis and multiple imputation. This study will provide novel and inclusive information about post-partum and annual screening for T2DM in women with previous GDM and the determinants of these rates, which will aid clinicians and healthcare professionals in improving the quality of provided health services.
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Evaluation of clinical progression of chronic kidney disease and its predictors using statistical and machine learning techniques: a retrospective cohort study from United Kingdom — Lutz Jermutus ...
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Evaluation of clinical progression of chronic kidney disease and its predictors using statistical and machine learning techniques: a retrospective cohort study from United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-11
Organisations:
Lutz Jermutus - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Alyshah Abdul Sultan - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Domingo Salazar - Collaborator - Astra Zeneca Ltd - UK Headquarters
Glen James - Collaborator - Astra Zeneca Ltd - UK Headquarters
Irena Brooks-Smith - Collaborator - Astra Zeneca Ltd - UK Headquarters
Jerry Wu - Collaborator - Astra Zeneca Ltd - UK Headquarters
Jolyon Faria - Collaborator - Astra Zeneca Ltd - UK Headquarters
Michail Doulis - Collaborator - Astra Zeneca Ltd - UK Headquarters
Xiang Ji - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
The overall aim of this study is to evaluate and predict disease progression in patients with CKD.
Specific study objective
1. Assess progression of CKD patients with late CKD stage 2, 3 and 4 to determine an appropriate definition of a fast-progressor versus a slow/non-progressor.
2. Identify clinical and demographic characteristics of patients who are faster and more severe progressors and use statistical and machine learning techniques to predict the risk of rapid CKD progression based on patients characteristics and comorbidities.
3. Examine the association between the slope of eGFR over time and adverse events (ESRD, CVD and all-cause mortality).Rationale
Our proposed study aims to assess projection trajectories in CKD patients and how prior GFR decline can predict future CKD decline and other adverse events (ESRD, CVD and mortality) in these patients. This will facilitate the definition of inclusion criteria that will optimise patient recruitment in clinical trials and thereby ensuring an adequate therapeutic window for patient enrolment into clinical trials. We will also explore the use of both statistical and machine learning approaches to examine which methods are better suited for this challengeDescription: Technical Summary
Objective
Whilst only a small proportion of CKD patients progress to end stage renal disease, there is dearth of knowledge on factors predictive of CKD progression. Our proposed study aims to assess projection trajectories in CKD patients and evaluate how prior GFR decline and clinical characteristics can predict future CKD decline and other adverse events (ESRD, CVD and mortality). This will facilitate the definition of inclusion criteria for clinical trials, thus improving patient recruitment and trial success.Method and Analysis plan
We will identify individuals with first ever recorded diagnosis of CKD between 2004 and 2018 in CPRD-HES linked data. CKD will be defined using two consecutive measurements of estimated glomerular filtration rate (eGFR) at a value of less than or equal to 75 ml/min/1.73m2, at least 3 months apart. CKD progression will be assessed using eGFR readings after CKD diagnosis and based on their eGFR slopes, patients will be categorised as slow or rapid progressors. By exploring a carefully selected set of modelling techniques (simple directed approaches, Bayesian clustering, Neural networks; please see justification below), we will assess whether rapid CKD progression can be predicted based on patient characteristics and comorbidities. Finally, we will use Cox regression model to compare risk of adverse outcome (mortality, end stage renal disease (ESRD)) among slow and rapid progressors.
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Characterising end of life health care expenditure — Nigel Rice ...
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Characterising end of life health care expenditure
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-01
Organisations:
Nigel Rice - Chief Investigator - University of York
Nigel Rice - Corresponding Applicant - University of York
Panagiotis Kasteridis - Collaborator - University of York
Rita Santos - Collaborator - University of YorkOutcomes:
The outcomes will be patientÂs health care expenditures measured in each of the 36 months prior to death. They will comprise primary care, inpatient, outpatient, and A&E costs.
Description: Technical Summary
Proposals aiming to reduce health care costs often target the high cost of care during the last year of life. However, focusing on such a short period is myopic. The majority of the highest cost group patients are not in their last year of life. At the population level, the proportion of the annual spending that is due to caring for individuals in their last year of life is considerably smaller than the proportion of the three years spending that is due to caring for individuals in the last three years of life.
To gain a complete understanding of EOL health care expenditure attention needs to be paid to patterns or trajectories of spending during longer periods before death. This project will characterise EOL care into profiles of expenditure during the final three years of life and will determine the drivers and characteristics that underlay such profiles. Our sample are individuals who died during the calendar years 2012-2014. We will use CPRD data to identify primary care activity and linked HES data to identify inpatient, outpatient and A&E activity over a period of three years prior to their death. For each decedent, we will calculate aggregate health care costs in 36 monthly intervals.
We will estimate group-based trajectory models (GBTM) to identify distinct trajectories of health care spending in the data such as persistent high users, progressive users, and late rise users of EOL care. Once the expenditure trajectories have been defined, the probability of membership to a cluster will be modelled as a function of patient-specific covariates such as age, diagnostic groups; chronic conditions, and number of co-morbidities.
More detailed information about the profile of spending near EOL can shed light on potential strategies to mitigate costs while preserving high-quality care at EOL.
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Utilization, Effectiveness, and Safety of SGLT2 Inhibitors Among Patients with Type 2 Diabetes Mellitus — Samy Suissa ...
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Utilization, Effectiveness, and Safety of SGLT2 Inhibitors Among Patients with Type 2 Diabetes Mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-11
Organisations:
Samy Suissa - Chief Investigator - McGill University
Pierre Ernst - Corresponding Applicant - McGill University
Anat Fisher - Collaborator - University of British Columbia
Antonios Douros - Collaborator - McGill University
Audray St-Jean - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Karine Suissa - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Lisa Lix - Collaborator - University of Manitoba
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Sebastian Schneeweiss - Collaborator - Aetion, Inc
Sophie Dell'Aniello - Collaborator - McGill University
Vanessa Brunetti - Collaborator - McGill UniversityOutcomes:
Major adverse cardiac events including myocardial infarction, ischemic stroke, and cardiovascular death
Hospitalization for heart failure
Urosepsis
Diabetic ketoacidosis
Lower extremity amputationDescription: Technical Summary
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of drugs used in the treatment of type 2 diabetes. Clinical trials have suggested that SGLT2 inhibitors reduce the incidence of major adverse cardiac events (MACE) among patients with type 2 diabetes and either established cardiovascular disease or at high cardiovascular risk compared with placebo. However, the effectiveness of SGLT2 inhibitors in a real-world setting remains poorly understood. Furthermore, recent safety concerns have emerged regarding these agents and potential increased risks of severe urinary tract infection (urosepsis), diabetic ketoacidosis (DKA), and lower extremity amputation. Our objective is therefore to examine the utilization, effectiveness, and safety of SGLT2 inhibitors in a real-world setting. To accomplish this objective, we will first describe the use of antidiabetic drugs between 2006 and 2018. Using a prevalent new-user design, we will then conduct a time-conditional propensity score matched analysis comparing users of SGLT2 inhibitors to users of dipeptidyl peptidase-4 (DPP-4) inhibitors for the following outcomes: MACE, the individual components of MACE (myocardial infarction, ischemic stroke, cardiovascular death), and hospitalization for heart failure. In addition, we will create a study cohort of new users of antidiabetic drugs between 2013 and 2018. Cox proportional hazards models will be used to estimate site-specific adjusted hazard ratios and corresponding 95% confidence intervals of the association between SGLT2 and DPP-4 inhibitor use and urosepsis, DKA, and lower extremity amputation. Site-specific results will be combined by random-effects meta-analysis to provide an overall assessment of the effectiveness and safety of SGLT2 inhibitors among patients with type 2 diabetes.
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An investigation into the risk of suicide and self-harm amongst people with alcohol or opioid dependence and disorders — Prianka Padmanathan ...
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An investigation into the risk of suicide and self-harm amongst people with alcohol or opioid dependence and disorders
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-25
Organisations:
Prianka Padmanathan - Chief Investigator - University of Bristol
Prianka Padmanathan - Corresponding Applicant - University of Bristol
Becky Mars - Collaborator - University of Bristol
David Gunnell - Collaborator - University of Bristol
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jo Kimber - Collaborator - King's College London (KCL)
Matt Hickman - Collaborator - University of Bristol
Paul Moran - Collaborator - University of Bristol
Rachael Hughes - Collaborator - University of BristolOutcomes:
Suicides including undetermined deaths; Hospital admissions with self-harm
Description: Technical Summary
The general objective of the proposed research is to quantify the rate of suicide and non-fatal self-harm amongst people with alcohol dependence or opioid use disorder, and to investigate factors that might influence this rate.
The primary exposures are alcohol dependence or opioid use disorder. These two exposures will be investigated separately. A previously defined CPRD case definition for alcohol dependence will be used. Opioid use disorder will based on a patient having either been given a relevant diagnosis or a prescription of opiate substitution treatment. The primary outcomes are suicide and self-harm. Hospital admissions due to self-harm will be determined using Hospital Episode Statistics (HES) data. Deaths by suicide will be determined using Office of National Statistics (ONS) Data.
The study will have three specific aims:
1) To determine the incidence rates of suicide and self-harm amongst people with alcohol dependence or opioid use disorder in England, and compare these rates with those occurring amongst people without alcohol dependence or opioid use disorder respectively using Cox proportional hazards regression.
2) To investigate the variation in rate of suicide and self-harm amongst people with alcohol dependence or opioid use disorder in England between 1998 and 2018 in relation to economic and political changes using time series models (Joinpoint regression and interrupted time-series analysis).
3) To investigate whether there is a difference in rate of suicide and self-harm among people with alcohol dependence or opioid use disorder before, during or after treatment with alcohol detoxification or opioid substitution therapy respectively using Poisson regression analysis.
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Investigating the extent to which exposure to varicella boosts Varicella zoster virus-immunity: a self-controlled case-series, 1997-2018 — Harriet Forbes ...
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Investigating the extent to which exposure to varicella boosts Varicella zoster virus-immunity: a self-controlled case-series, 1997-2018
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-08
Organisations:
Harriet Forbes - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Adam Finn - Collaborator - University of Bristol
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Judith Breuer - Collaborator - University College London ( UCL )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Herpes zoster
Description: Technical Summary
Varicella is a common childhood infection caused by the varicella-zoster virus (VZV). After primary VZV infection, the virus remains in the body and zoster is caused by the reactivation of VZV, typically in late-life. The varicella vaccine is not recommended in the United Kingdom, due to concerns that removing varicella contacts from the population through immunisation would lead to an outbreak of zoster cases in adults. Adults exposed to varicella contacts are thought to have their VZV-specific cell-mediated immunity boosted and therefore their risk of zoster reduced. However, the magnitude of this exogenous boosting effect is poorly understood.
In countries which universally vaccinate children against varicella, such as the United States, there has been a gradual increase in the rate of zoster since its introduction. However, the dramatic increases in the rate of zoster, as predicted by many modelling studies, have not been observed. This has led some commentators to question whether VZV-boosting from exposure to varicella contacts is as significant as previously thought.
This study will use data from the UK to explore the association between having a household member with varicella and the subsequent risk of zoster. Within-person comparisons will be undertaken using the self-controlled case-series method. Participants will have a first-ever diagnosis of zoster and a household member with varicella within the study period. Zoster incidence in periods following varicella exposure will be compared with incidence in other time periods, using conditional Poisson Regression. Age-adjusted incidence ratios (IRs) and 95% confidence intervals (CIs) will be calculated.
Source -
All-cause Mortality in Infants vaccinated in the routine childhood immunisation schedule in general practice in the United Kingdom — Jenny Wong ...
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All-cause Mortality in Infants vaccinated in the routine childhood immunisation schedule in general practice in the United Kingdom
Datasets:GP data, CPRD Mother-Baby Link; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-21
Organisations:
Jenny Wong - Chief Investigator - MHRA
Jenny Wong - Collaborator - MHRA
Katherine Donegan - Collaborator - MHRAOutcomes:
Number of patients with at least one vaccination record for pre-specified vaccines during the study period; a fatal outcome including cause of death and death date. All outcomes will be stratified by age, and where possible, by pre-term birth and deprivation score.
Description: Technical Summary
The objective of this study is to assess all-cause mortality rates, unexplained infant death rates (including sudden infant death syndrome), and sudden infant death syndrome (SIDS) rates in infants following vaccination with routine childhood vaccines according to the UK immunisation schedule. Age-specific mortality rates following vaccination at 8 weeks, 12 weeks, 16 weeks and 12 months of age will be calculated over a period of 11 years stratified by deprivation score and pre-term birth. Currently available data on national rates of infant mortality do not stratify risk to specific enough age bands to be fully robust for use in addressing questions of acute risk. Further, patients receiving vaccinations in the primary care setting will be a subset of the whole population and it is likely that the children at highest risk of early death do not follow the routine vaccination schedule. Hence, using estimates of risk in the whole population will over-estimate the expected background risk in the vaccinated population.
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Comparative safety profile of antidiabetic drug regimens containing SGLT-2 inhibitors and/or GLP-1 receptor agonists among type 2 diabetes patients — Darren Ashcroft ...
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Comparative safety profile of antidiabetic drug regimens containing SGLT-2 inhibitors and/or GLP-1 receptor agonists among type 2 diabetes patients
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-14
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Alison Wright - Corresponding Applicant - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Iain Buchan - Collaborator - University of Manchester
Martin Rutter - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Naveed Sattar - Collaborator - University of Glasgow
Richard Emsley - Collaborator - King's College London (KCL)Outcomes:
Study 1
? Fatal and non-fatal major cardiovascular events (myocardial infarction/acute coronary syndrome, stroke/transient ischaemic attack, unstable angina).
? Heart failure
Study 2
? Osteoporotic fractures (fractures at any of the six anatomic locations: hip, vertebra, forearm, humerus, ribs and pelvis)
Study 3
? All-cause mortality
? Cardiovascular mortalityDescription: Technical Summary
Maintaining glycaemic control is an integral part of managing type 2 diabetes and often requires pharmacological agents to achieve this. With newer drugs entering the market it is important to assess the safety and efficacy of these drugs used alone and in combination and to establish their place in the treatment algorithm for guiding clinical decision making. The proposed study will examine the effect of SGLT-2 inhibitor regimens, GLP-1 receptor agonist regimens and combined SGLT-2 inhibitor/GLP-1 receptor agonist regimens on risk of major cardiovascular events, osteoporotic fractures, all-cause and cardiovascular mortality.
Data will be obtained from three databases; CPRD GOLD, CPRD Aurum and the SAIL Databank (routinely-collected health care records from Wales), with a common protocol applied across the databases for cohort construction and analysis. The study populations will consist of any individual initiating a non-insulin antidiabetic drug up to 31 January 2018, with follow-up until 31 July 2018. In a nested case-control design, those who experience the outcome of interest will be matched to those who have not experienced the outcome at the time of the case event. Up to 20 controls will be randomly selected for each case and matched on the basis of sex, age, date of study cohort entry, and duration of treated diabetes. Cohorts will be built separately for each outcome. Odds ratios for the outcomes of interest among patients receiving SGLT-2 inhibitors and/or GLP-1 receptor agonists, as compared with those receiving other antidiabetic combination regimens, will be estimated from conditional logistic regression models and pooled across the three databases with the use of random-effects models. To investigate risks associated with SGLT-2 inhibitors compared with GLP-1 receptor agonists, a new-user cohort design will be implemented. Weighted Cox regression models will be used to estimate study-specific hazard ratios and pooled across the three databases.
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The weight loss effects of glucagon-like peptide-1 receptor agonists and the risk of breast cancer in women with type 2 diabetes — Samy Suissa ...
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The weight loss effects of glucagon-like peptide-1 receptor agonists and the risk of breast cancer in women with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-11
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Blánaid Hicks - Collaborator - Queen's University Belfast
Christina Santella - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Nathaniel Bouganim - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
The primary outcome of interest is a diagnosis of breast cancer, as identified by pre-specified CPRD Read Codes (Appendix 1).
Description: Technical Summary
The use of glucagon-like peptide-1 (GLP-1) receptor agonists in the treatment of type 2 diabetes has markedly increased over the years, in part due to their favourable effects on cardiovascular outcomes. However, their association with breast cancer risk became a safety concern when they were initially introduced. Indeed, there were imbalances in breast cancer events with the GLP-1 receptor agonist, liraglutide, in premarketing trials which were typically of short duration. In contrast, this imbalance was no longer observed in the large LEADER trial of liraglutide that followed patients over a three-year period. While one hypothesis for these contradictory findings implicates a possible tumour promoting effect, another hypothesis implicates the rapid weight loss induced by GLP-1 agonists leading to a transient increased detection of breast cancers. Specifically, it has been shown that obese women are significantly less likely to undergo mammography screening or breast examination than women of normal weight. Thus, the rapid weight loss induced by GLP-1 receptor agonist may lead to a better detection of breast lumps and to an increased frequency and accuracy of screening. While the association between GLP-1 receptor agonists and breast cancer has been previously investigated in one observational study, it remains unclear whether the weight loss induced by these drugs has an effect on breast cancer incidence. To address this question, we will use the Clinical Practice Research Datalink to assemble a cohort of women who initiated antidiabetic drugs between January 1 2007 and December 31 2017, with follow-up until December 31 2018. Time dependent Cox proportional hazards models will be used to estimate hazard ratios and 95% confidence intervals of breast cancer, comparing GLP-1 receptor agonist maximal weight loss (<5%, 5%-10%, >10%) with dipeptidylpeptidase-4 inhibitors. Thus, this study will provide further insight on the potential weight loss effects of GLP-1 receptor agonists on the incidence of breast cancer.
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Validation of Asthma-COPD Overlap Syndrome in the Clinical Practice Research Datalink (CPRD) — Zhiwei Gao ...
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Validation of Asthma-COPD Overlap Syndrome in the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-07
Organisations:
Zhiwei Gao - Chief Investigator - Memorial University of Newfoundland ( MUN )
Joseph Amegadzie - Corresponding Applicant - Memorial University of Newfoundland ( MUN )
Jamie Farrell - Collaborator - Memorial University of Newfoundland ( MUN )
JM Gamble - Collaborator - University Of Waterloo
Mark Wright - Collaborator - Not from an Organisation
William K. Midodzi - Collaborator - Memorial University of Newfoundland ( MUN )Outcomes:
Positive Predictive Value (PPV)
Description: Technical Summary
The overall aim of our study is to determine the positive predictive value (PPV) of four algorithms among patients assumed to have been diagnosed with asthma-COPD overlap syndrome within CPRD GOLD. In order to achieve this, a cross-sectional study consisting of patients with possible diagnosis of asthma-COPD overlap syndrome will be constructed using these algorithms in which 200 cases will be randomly selected. Diagnostic information about these patients will be filled out by GPs via online questionnaire. The information collected from the GPs will be reviewed by two independent respiratory physicians whose opinions will be considered as the gold standard to assess PPV of an asthma-COPD overlap syndrome within CPRD. The main analysis is calculation of PPVÂs for each of our four algorithms. PPV is denoted as the proportion of true positives among those assumed to have been diagnosed with asthma-COPD overlap syndrome.
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Epidemiology and treatment pathways of ankylosing spondylitis: a retrospective UK database analysis — Christopher Morgan ...
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Epidemiology and treatment pathways of ankylosing spondylitis: a retrospective UK database analysis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-28
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Abigail White - Collaborator - Novartis UK
Amie Scott - Collaborator - KMK Consulting Inc
Haijun Tian - Collaborator - Novartis Pharmaceuticals Corporation
Mark Tomlinson - Collaborator - Novartis UKOutcomes:
Incidence and prevalence, demographic profile, co-morbidity, biochemical markers, treatment pathways, mortality.
Description: Technical Summary
This study aims to describe the epidemiology and treatment of ankylosing spondylitis (AS) in the United Kingdom. The study will be partly descriptive but will also compare outcomes between exposed (AS) and non-exposed matched patients. Patients of acceptable research quality and from up-to-standard practices with a diagnosis of AS will be determined by Read codes in the Clinical and Referral tables of their primary care record or ICD-10 in the admitted patient care table. Date of first diagnosis will be used as the index date. The incidence and prevalence of AS will be presented over the period 2003-17. AS patients will be matched to non-exposed patients from the same practice by age and gender. Baseline demographic characteristics and relevant co-morbidities (back pain, axial spondyloarthritis (AxSpA), depression, cardiovascular disease, cancer, infections, uveitis, inflammatory bowel disease and psoriatic arthritis) will be compared using t-tests (or non-parametric equivalent) for continuous data and chi2 for categorical. For AS patients, summary measures of relevant baseline biochemistry (human leucocyte antigen (HLA) B27, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) will be presented. Time from first AS-like symptoms to first diagnosis of AS, first diagnosis of AS to first outpatient appointment in either rheumatology or orthopaedics and first diagnosis of AS and to first treatment will be presented using Kaplan-Meier curves and summary statistics. Therapies used to treat AS (biological response modifiers, non-steroidal anti-inflammatory drugs (NSAIDS) or conventional disease modifying anti-rheumatic drugs (DMARDs) will be ascertained from the CPRD GOLD therapy table and HES admitted patient care and outpatient tables for biologics. Time from index date to death will be presented by Kaplan-Meier and compared between AS-exposed and non-exposed patients using a Cox-Proportional Hazards model for cardiovascular and all-cause mortality.
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The association of cancer and autism spectrum condition in a UK population — Simon Baron...
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The association of cancer and autism spectrum condition in a UK population
Datasets:GP data, CPRD Mother-Baby Link; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-05
Organisations:
Simon Baron-Cohen - Chief Investigator - University of Cambridge
Elizabeth Weir - Corresponding Applicant - University of Cambridge
Adriana Cherskov - Collaborator - University of Cambridge
Carrie Allison - Collaborator - University of Cambridge
Ken Ong - Collaborator - University of Cambridge
Rupert Payne - Collaborator - University of BristolOutcomes:
Autism
- Testicular Cancer
- Ovarian Cancer
- Overall Cancer
- Prostate Cancer
- Breast CancerDescription: Technical Summary
The objective is to assess the relationship between autism spectrum conditions (henceforth autism) and cancer risk, overall and for cancers mediated by sex steroid hormones. We will select individuals with an autism diagnosis documented in the Clinical Practice Research Datalink (CPRD) between January 1990 and December 2015. From that population, we will select individuals with a documented case of cancer in CPRD or the National Cancer Registration and Analysis Service (NCRAS) and determine the age of first diagnosis We will use Poisson regression and one-way ANCOVA analyses to determine if incidence of cancer and mean age of first cancer diagnosis, respectively, are significantly different between autistic individuals and controls, for cancer overall and for breast, ovarian, testicular, and prostate cancers. We will use information in the CPRD and linked through the 2015 Patient Level Index of Multiple Deprivation to control for potential covariates. Additionally, we will apply the same procedure to mothers of autistic individuals by using the Mother to Baby Link to select non-autistic mothers of autistic individuals and compare them against a control group of mothers of individuals without autism to determine if there are differences in cancer incidence and mean age of first cancer diagnosis.
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Medical conditions and medications potentially associated with lung cancer in a population of never smokers in CPRD — Maria Teresa Landi ...
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Medical conditions and medications potentially associated with lung cancer in a population of never smokers in CPRD
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-22
Organisations:
Maria Teresa Landi - Chief Investigator - National Cancer Institute ( NCI )
Maria Teresa Landi - Corresponding Applicant - National Cancer Institute ( NCI )
Curt DellaValle - Collaborator - National Cancer Institute ( NCI )
Marie Bradley - Collaborator - Food and Drug Administration - FDA
Monica DArcy - Collaborator - National Cancer Institute ( NCI )
Ruth Pfeiffer - Collaborator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Collaborator - National Cancer Institute ( NCI )Outcomes:
Lung cancer
Description: Technical Summary
Worldwide approximately 53% of women and 15% of men with lung cancer are never smokers (Parkin 2002). Known risk factors for lung cancers include environmental tobacco smoke, air pollution, radon, asbestos, silica and heavy metals (Samet 2009; Sun 2007; Subramanian & Govindan 2007). More recently, a series of studies have uncovered genomic regions associated with genetic susceptibility that might be unique to East Asian female never smokers (Seow 2017; Lan 2012). Still lung cancer in never smokers can not be fully attributed to known environmental or genetic risk factors (Samet 2009). Risks associated with viral infections, hormonal factors, and previous lung diseases have also been identified (Samet 2009; Sun 2007; Subramanian & Govindan 2007). However, evidence of such associations in never smokers has been modest or inconsistent. Moreover, differences in molecular profiles, response to treatment, and incidence by gender that have been observed between lung cancers that develop in never smokers and smokers suggest different disease etiology (Sun 2007; Korpanty 2018). These differences highlight the importance of further investigating the etiology of lung cancer in never smokers. We propose to investigate the risk of lung cancer among the never smoker population in CPRD associated with medical conditions and medication use.
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Costs and clinical consequences of gastrointestinal bleeding events in patients with atrial fibrillation — Sreeram Ramagopalan ...
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Costs and clinical consequences of gastrointestinal bleeding events in patients with atrial fibrillation
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-25
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Cormac Sammon - Corresponding Applicant - PHMR Associates
Mihail Samnaliev - Collaborator - PHMR Associates
Sharada Weir - Collaborator - Maverex Ltd
Tzu-Chun Kuo - Collaborator - PHMR AssociatesOutcomes:
The primary Âoutcome in this project will be the total healthcare costs attributable to GI bleeding, which will include costs associated with GP consultations, inpatient stays, outpatient visits and prescriptions.
The secondary outcomes in the project will be treatment discontinuation, subsequent bleeds, stroke/TIA and death.
Description: Technical Summary
Oral anticoagulant (OAC) therapy is used to reduce the risk of stroke in non-valvular atrial fibrillation (NVAF) patients but carries a risk of causing or exacerbating bleeding.
The objective of the study is to estimate the 3-year healthcare costs attributable to a GI bleed in AF patients by comparing total costs among individuals with AF who experienced GI bleeding with a matched control group of AF patients who did not suffer GI bleeding. The primary outcome is total healthcare costs (costs associated with GP consultations, inpatient stays, outpatient visits and prescriptions). The secondary outcomes are treatment discontinuation, subsequent bleeds, stroke/TIA and death.
Controls will be selected using propensity score matching. Logistic regression of the risk of GI bleeding among cases and potential control subjects will be modelled as a function of a set of demographics, stroke risk factors, bleeding risk factors, year of first eligibility in data, and other covariates. Nearest neighbour matching on the propensity score with replacement will be carried out to match each bleeding case with up to 4 controls.
For both cases and controls, total costs will be estimated by encounter type. Standard unit cost methodology will be applied to obtain costs for primary care and outpatient hospital encounters. For inpatient stays, costs will be estimated based on the clinical complexity of the patient using NHS Healthcare Resource Groups (HRGs). For prescription drugs, costs will be applied using the mean cost of drugs within the applicable BNF subchapter.
A difference-in-differences approach will be taken to estimate the costs attributable to GI bleeds. We will estimate the change from baseline year to incidence year in total healthcare costs for patients who have experienced a GI bleed following AF (cases) net of the change over time in costs experienced by AF patients who did not experience a GI bleed during the period (controls).
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Trends in incidence of first diabetic foot ulcer and mortality in patients with type I and type II diabetes mellitus — Frank de Vries ...
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Trends in incidence of first diabetic foot ulcer and mortality in patients with type I and type II diabetes mellitus
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-08
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Johan Roikjer - Collaborator - Aalborg University Hospital
Johanna Driessen - Collaborator - Utrecht University
Johannes T.H. Nielen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Morten Jensen - Collaborator - Aalborg University Hospital
Nicolaas Schaper - Collaborator - Maastricht University
Niels Ejskjaer - Collaborator - Aalborg University Hospital
Nikki Werkman - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Peter Vestergaard - Collaborator - Aalborg University HospitalOutcomes:
1)Â Â Â Â Trends in incidence of first DFU and hospitalization for first DFU
2) The following patient characteristics for all patients with a first DFU: age, duration of diabetes, history of CN at the date of the first DFU
3) 1- and 5-year mortality rates in patients with a first DFU.Description: Technical Summary
In CPRD, all patients with a diagnosis of diabetes will be included in the initial study cohort.
Our primary outcome will be trends in incidence of first Diabetic Foot Ulcer (DFU).
Patients will be followed from the index date up to the date of death, end of data collection, end of study period, or the date of a DFU, whichever comes first. DFUs will be identified by use of read codes.The incidence rates in each calendar year will be calculated as the sum of the DFUs in that year divided by the total time at risk in that given calendar year. This will be expressed as the number of events per 1000 person-years. We will break down these rates by gender, age categories, and type of diabetes (T1DM or T2DM).
Furthermore, the following patient characteristics at the time of the first DFU will be determined, age, time since index date as a proxy for diabetes duration and history of Charcot Neuroarthropathy (CN).
For patients with a diagnosis of a DFU we will also calculate the 1- and 5-year mortality rates.
All analyses will be stratified by sex, age categories and type of diabetes (T1DM and T2DM).
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What are the optimal blood pressure targets for patients in atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants? — Thompson Robinson ...
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What are the optimal blood pressure targets for patients in atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-12
Organisations:
Thompson Robinson - Chief Investigator - University of Leicester
Jatinder Minhas - Corresponding Applicant - University of Leicester
Amit Mistri - Collaborator - University Hospitals Of Leicester
Briana Coles - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of LeicesterOutcomes:
Outcomes include first stroke, recurrent stroke, myocardial infarction, symptomatic intracranial bleed, significant gastrointestinal bleed, CVD-related mortality and all-cause mortality.
Description: Technical Summary
The primary objective of this research is to understand the blood pressure (BP) thresholds at which recurrent stroke, myocardial infarction, all cause-mortality as well as symptomatic intracranial haemorrhage and significant gastrointestinal bleeding occur post non-VKA oral anticoagulant (NOACs) initiation for atrial fibrillation (AF). Using HES- and ONS-linked data, pre-initiation BP, post-initiation BP and trend values (including BP variability) parameters will be examined for relationships with adverse cardiovascular outcomes in an effort to determine a 'threshold' mean systolic BP for initiation and maintenance on NOACs.
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Characteristics of lung cancer patients in clinical practice and potential study eligibility for clinical trials evaluating tyrosine kinase inhibitors or immune checkpoint inhibitors. — Frank de Vries ...
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Characteristics of lung cancer patients in clinical practice and potential study eligibility for clinical trials evaluating tyrosine kinase inhibitors or immune checkpoint inhibitors.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-22
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Anne-Marie Dingemans - Collaborator - Maastricht University Medical Centre
Ard van Veelen - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Robin van Geel - Collaborator - Maastricht University Medical Centre
Sander Croes - Collaborator - Maastricht University Medical Centre
Shahab Abtahi - Collaborator - Utrecht UniversityOutcomes:
Overall survival
Description: Technical Summary
Primary objective is to compare the characteristics of patients included in phase III randomized clinical trials that evaluated targeted therapies or immunotherapy for treatment of lung cancer with the characteristics of patients with lung cancer in CPRD from 2014 through 2018.
Secondary objective is to compare overall survival among patients with lung cancer in CPRD (2014-2018) who were eligible for inclusion in phase III RCTs that evaluated targeted therapies or immunotherapy for treatment of lung cancer with those in CPRD who did not meet those eligibility criteria.
First, we will create a base study population including all patients with any diagnosis of lung cancer between 01-01-2014 and 31-12-2018. The comorbidities of the included patients will be described, and subsequently the included patients will be compared based on their characteristics, with the study population of different clinical trials. This will enable us to evaluate which proportion of UK lung cancer patients would be eligible to participate in one of the clinical trials, thereby defining the representativeness of the included study population in the clinical trials. In addition to representativeness, for all lung cancer patients in CPRD, Kaplan-Meier analyses will compare overall survival between those who met eligibility criteria for each individual RCT versus those did not meet eligibility criteria. Corresponding Kaplan-Meier curves will compare overall survival in CPRD patients whose characteristics made them eligible or ineligible for inclusion in published RCTs. In addition, Cox proportional hazards analyses will estimate crude and age-sex adjusted hazard ratios (HRs) of overall survival of patients with lung cancer, comparing patients who were eligible for participation in RCTs to those who were not.
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Understanding the harms of antihypertensives, statins and antiplatelets for prevention of cardiovascular disease: A prognostic modelling and casual inference study — James Sheppard ...
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Understanding the harms of antihypertensives, statins and antiplatelets for prevention of cardiovascular disease: A prognostic modelling and casual inference study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-22
Organisations:
James Sheppard - Chief Investigator - University of Oxford
James Sheppard - Corresponding Applicant - University of Oxford
Ariel Wang - Collaborator - University of Oxford
Constantinos Koshiaris - Collaborator - University of Oxford
Ghadeer Ghosheh - Collaborator - University of Oxford
Kym Snell - Collaborator - Keele University
Lucinda Archer - Collaborator - Keele University
Richard Hobbs - Collaborator - University of Oxford
Richard McManus - Collaborator - University of Oxford
Richard Riley - Collaborator - Keele University
Richard Stevens - Collaborator - University of Oxford
Rupert Payne - Collaborator - University of Bristol
Sarah Lay-Flurrie - Collaborator - University of Oxford
Subhashisa Swain - Collaborator - University of Oxford
Tingting Zhu - Collaborator - University of OxfordOutcomes:
Primary outcomes - Falls; Myopathy/muscle pain; Intracerebral haemorrhage
Secondary outcomes  Fracture; Syncope; Hypotension (symptomatic); Acute kidney injury; Electrolyte abnormalities; Gout; Diabetes mellitus; Intracerebral haemorrhage; Cataract; Liver dysfunction; Dementia; Memory problems (including dementia); Gastrointestinal haemorrhage; Dyspnoea; Any adverse event
Specific outcomes will be examined in relation to exposure to either antihypertensives, statins or antiplatelets (details given in section N).
Description: Technical Summary
Background
The population is ageing and consequently, the number of people living with age-related chronic conditions is increasing. Polypharmacy (five or more prescribed medications) is common in older people and is associated with an increased risk of adverse drug reactions. Preventative medications, such as those used to manage blood pressure and cholesterol, are common in polypharmacy and often require large numbers of people to be treated to prevent a small number of cardiovascular disease (CVD) events. This leaves many individuals on drugs of little benefit, some of whom may be susceptible to side effects such as falls, kidney problems and muscle pain.Aims
This proposal aims to quantify the harms of cardiovascular prevention medication, and the characteristics of those people most likely to suffer them. This research is one part of a larger research programme to develop a clinical decision tool which estimates an individualÂs likelihood of benefiting or suffering harm from treatment.Methods
Aim 1: Derive prognostic models for an individualÂs risk of adverse events associated with cardiovascular prevention treatment (antihypertensives, statins and antiplatelets) using data from the CPRD GOLD. Adverse event outcomes will include falls (antihypertensives), myopathy (statins) and bleeding (antiplatelets).
Aim 2: Externally validate each model using data from the CPRD Aurum.
Aim 3: Use causal inference methods (multivariable regression, propensity score adjustment/matching, instrumental variable analysis) to examine whether modification of treatment could have an important impact on the risk of adverse events.
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Levothyroxine for the Treatment of Subclinical Hypothyroidism in Pregnancy: A Population-based Assessment — Samy Suissa ...
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Levothyroxine for the Treatment of Subclinical Hypothyroidism in Pregnancy: A Population-based Assessment
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-27
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Roxane Arel - Collaborator - McGill University
Sonia Grandi - Collaborator - University of Toronto
YA-HUI YU - Collaborator - Georgia State UniversityOutcomes:
Primary outcome: pregnancy loss and stillbirth
Secondary outcomes: hypertensive disorders in pregnancy, gestational diabetes, maternal death (during pregnancy or within 30 days of delivery or documented to be related to pregnancy), neonatal death (<30 days of delivery), placental abruption (premature separation of placenta from uterus after 20 weeks gestation), postpartum hemorrhage (?500 mL of blood loss in the 6-week postpartum period), preterm birth (onset of labor and cervical dilation <37 weeks gestation), or small-for-gestational age (<5th percentile).
Description: Technical Summary
We will conduct a population-based cohort study including women aged 15 to 45 with a first recorded pregnancy in the CPRD Pregnancy Registry between April 1, 2000 to March 31, 2018 with a diagnosis of SCH or an abnormal TSH (<10mlU/L) value. Our primary objective will be to compare the rate of a composite of pregnancy loss and stillbirth in women with SCH using levothyroxine to that in women with SCH not using levothyroxine. The secondary objectives are to describe the use of levothyroxine and to examine the rates of pregnancy complications including hypertensive disorders in pregnancy, gestational diabetes, maternal death, neonatal death, placental abruption, postpartum hemorrhage, pregnancy loss, preterm birth, small-for-gestational age, or stillbirth in women with SCH using levothyroxine to those in women with SCH not using levothyroxine and to examine if the association varies by timing of initiation, dose, and duration of use of levothyroxine during pregnancy. In our primary analysis, we will estimate the cumulative incidence proportion of our composite outcome using a pooled logistic regression analysis including a high-dimensional propensity score to adjust for known and unknown confounders. In our secondary analyses, we will use Cox proportional hazards models with a time-dependent exposure definition.
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Treatment pathways to severe asthma and health care resource utilisation in the UK — Betina Blak ...
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Treatment pathways to severe asthma and health care resource utilisation in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-08
Organisations:
Betina Blak - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Yi Lu - Corresponding Applicant - Evidera, Inc
Brian Murphy - Collaborator - Astra Zeneca Inc - USA
Dimitra Lambrelli - Collaborator - Evidera, Inc
Sharon MacLachlan - Collaborator - Evidera, Inc
Tamsin Morris - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
Asthma Medications (identified with gemscript codes in CPRD therapy file):
 Short-acting beta-agonist
 Long-acting beta-agonist
 Leukotriene receptor antagonist
 Oral corticosteroid
 Inhaled corticosteroid
 Inhaled corticosteroid / long-acting beta-agonist combination medicines
 OtherAsthma Exacerbations (identified with gemscript codes in CPRD therapy file, and hospital admissions recorded in primary care record [CPRD clinical and consultation files]. Should sample sizes permit and the entire sample is derived using HES, then hospitalisations will be identified using HES):
 An exacerbation will be defined according to the published algorithm
o A worsening of asthma requiring an A&E visit /hospital admission (i.e., the patient is admitted to the hospital with an asthma medical code) or
o OCS treatment (receipt of an OCS prescription within 2 weeks of an asthma medical code)Exacerbations occurring within 7 days of the end date of OCS prescription, A&E admission, hospital discharge, or HES spell will be considered as the same exacerbation event.
Description: Technical Summary
Severe asthma typically refers to asthma that remains uncontrolled despite treatment with routine asthma medications such as inhaled corticosteroids and leukotriene receptor antagonists. Whilst severe asthma affects around only 5% of all patients with asthma, it is responsible for approximately 50% of the economic costs attributable to the disease, representing a severe economic burden. In addition, patients with severe asthma suffer a serious reduction in quality of life; patients have frequent Accident & Emergency (A&E) visits and are often unable to work or go to school as a result of their condition. Using a cohort of asthma patients, we will examine the treatment pathways for asthma patients to their severe asthma diagnosis and describe health care resource utilisation including referrals through to severe asthma. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
Source -
Characterisation and natural history of non-exacerbating chronic obstructive pulmonary disease patients in a general practice-based population — Jennifer Quint ...
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Characterisation and natural history of non-exacerbating chronic obstructive pulmonary disease patients in a general practice-based population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-02-21
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Alexandra Lenoir - Corresponding Applicant - Imperial College London
Debbie Jarvis - Collaborator - Imperial College LondonOutcomes:
1.     Clinical characteristics of non-exacerbating compared to exacerbating COPD patients, such as general demographics, degree of dyspnoea, severity of obstruction at spirometry, smoking history, medication, previous or concomitant other lung diseases and other comorbidities
2. Mortality rates and causes of death in non-exacerbating compared to exacerbating COPD patients3. Health care utilisation
Description: Technical Summary
Chronic obstructive pulmonary disease (COPD) has proven to be a heterogeneous disease with regard to symptoms, radiological findings, type of inflammatory response, response to inhaled corticosteroids and comorbidities. However, it is especially the frequency and severity of acute exacerbations of COPD (AECOPD), which shapes lung function trajectories and survival.
Recent data points at a large subgroup of COPD patients less susceptible to exacerbation, and this trait appears to be stable over time for periods as long as ten years. Little is known about the nature of this non-exacerbating phenotype even though one out of four COPD patients seems to belong to this category.
Our design will include as a first part a cross sectional study describing the clinical characteristics of non-exacerbating COPD patients, such as general demographics, degree of dyspnoea, severity of obstruction by spirometry, smoking history, medication, previous or concomitant other lung diseases and other comorbidities. We will then conduct a historical cohort study aiming at comparing mortality rates between non-exacerbating and exacerbating COPD patients as well as causes of death in both groups. Non-exacerbating COPD patients will be defined through a baseline period of three years after inclusion, with no exacerbation during this time. Cox proportional hazards regression will be used. As primary care is the management setting for most COPD patients, the Clinical Practice Research Database (CPRD) should be a representative source of data for our study.
Source
2019 - 01
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Mapping the opportunities for earlier diagnosis and characterising the management costs of psoriasis and impact of key co-morbidities — Darren Ashcroft ...
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Mapping the opportunities for earlier diagnosis and characterising the management costs of psoriasis and impact of key co-morbidities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Darren Ashcroft - Corresponding Applicant - University of Manchester
Alexander Thompson - Collaborator - University of Manchester
Cathy Morgan - Collaborator - University of Manchester
Christopher Griffiths - Collaborator - University of Manchester
Claire Reid - Collaborator - University of Manchester
Federica Ciamponi - Collaborator - University of Manchester
Georgios Gkountouras - Collaborator - University of Manchester
Katherine Payne - Collaborator - University of Manchester
Maha Abo-Tabik - Collaborator - University of Manchester
Peslie Ngâambi - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of Manchester
Sarah Willis - Collaborator - University of Manchester
Sean Gavan - Collaborator - University of Manchester
Thomas Allen - Collaborator - University of ManchesterOutcomes:
ÂPrimary care resource use (total and by region)
 Secondary care resource use (total and by region)
 Prevalence of co-morbidities
 Incidence of co-morbidities, referrals, and specific treatmentsDescription: Technical Summary
The first aim of the study will be to identify, and quantify, the use of healthcare resources (including: medicines; GP-visits, out-patient visits, A&E visits, hospitalisation) and associated costs to the NHS for the experienced patient journey of people with psoriasis and selected co-morbidities. The study will use a retrospective analysis of cohort data that links CPRD (clinical practice research datalink) with HES (hospital episode statistics) and ONS (Office National Statistics) mortality data and patient-level IMD (index of multiple deprivation). A cohort study comprising adult patients identified using a Read coded diagnosis of psoriasis between 01/04/2007 and 31/12/2018, and eligible for linkage to A&E, outpatient and inpatient HES and ONS records will be matched (on age, gender and practice) with unaffected comparison patients. Generalised linear models will be used to compare differences in resource use between groups. Selection will be restricted to patients registered with a contributing practice for at least one year and follow-up will end when the patient either dies, transfers out of the practice, last data collection, the end of the study period. The primary outcome will be use of healthcare resources, and key confounders will include presence of co-morbidities, BMI, smoking status and patient-level deprivation. The second aim will examine the healthcare contacts prior to the diagnosis of psoriasis using a case-control study design in order to explore potential opportunities for earlier diagnosis. The incidence of other specific health diagnoses, symptoms, referrals and treatments leading up to diagnosis of psoriasis will be determined and incidence risk ratios calculated using regression analysis for each year prior to diagnosis from all contacts through primary and secondary care sources of individuals with and without psoriasis.
Source -
An epidemiological study to compare adverse events associated with different formulations of latanoprost — Martin Frisher ...
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An epidemiological study to compare adverse events associated with different formulations of latanoprost
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-02
Organisations:
Martin Frisher - Chief Investigator - Keele University
Martin Frisher - Corresponding Applicant - Keele University
Nick Gibbons - Collaborator - Keele University
Stephen Chapman - Collaborator - Keele UniversityOutcomes:
Primary outcomes are hospital referrals from general practice to hospital ophthalmology and ophthalmology related hospital episodes as recorded in Hospital Episode Statistics. The secondary outcome is the rate of lubricant prescriptions in the study cohorts.
Description: Technical Summary
Retrospective cohort study comparing the differential risk of ophthalmology hospital referrals/episodes and coincident lubricant prescriptions in two cohorts of patients. The two cohorts are patients prescribed a) preservative-free formulations (Monopost-cohort 1) or b) preservative-containing formulations (latanoprost-cohort 2).The primary outcomes will be a) the annual rate of hospital referrals to ophthalmology and b) ophthalmology related hospital episodes for patients with linked Hospital Episode Statistics (HES) data. The secondary outcome is the rate of coincident lubricant eye drop prescribing in the two cohorts. As the two cohorts will be matched on age, gender and practice any observed differences are likely to be due to the preservative.
Source -
Cardiovascular disease in homeless individuals: epidemiology, risk prediction and management — Amitava Banerjee ...
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Cardiovascular disease in homeless individuals: epidemiology, risk prediction and management
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-21
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Amitava Banerjee - Corresponding Applicant - University College London ( UCL )
Atsunori Nanjo - Collaborator - University College London ( UCL )
Hannah Evans - Collaborator - University College London ( UCL )
John Robson - Collaborator - Queen Mary University of London
Neha Pathak - Collaborator - University College London ( UCL )
Robert Aldridge - Collaborator - University College London ( UCL )
Serena Luchenski - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
The primary outcomes will be a three composites of cardiovascular and cerebrovascular
conditions/syndromes;
 composite of acute vascular conditions/syndromes
 composite of chronic vascular conditions/syndromes
 composite of the acute and chronic conditions/syndromesAcute vascular condition/syndromes will be defined as Coronary artery disease (unstable angina, myocardial infarction, acute coronary syndromes); Peripheral arterial disease (claudication, acute limb ischaemia, lower limb amputation); Cerebrovascular disease (stroke/TIA); Heart failure; Atrial fibrillation; Aortic disease (e.g. aortic aneurysm, aortic dissection); Cardiac arrest; Sudden cardiac death; Mortality (all-cause, cardiovascular).
Chronic vascular condition/syndromes will be defined as Coronary artery disease (stable angina); Peripheral arterial disease (chronic limb ischaemia); Aortic disease (e.g. hypertension, atherosclerosis).
Secondary outcomes include each of the chronic and acute vascular conditions/syndromes listed above in turn as well as the following; healthcare resource utilisation; cardiovascular-related and non-cardiovascular primary care consultations, emergency and elective inpatient admissions, outpatient attendances, A&E attendances procedures; Missed elective inpatient appointments; Missed emergency inpatient appointments; missed outpatient appointments; missed GP appointments; prescriptions of cardiometabolic drug prescriptions (antiplatelets [e.g. aspirin], lipid-lowering therapies [e.g. statins]; antihypertensives [e.g. ACE inhibitors]; CABG; Angioplasty/PCI [percutaneous coronary intervention]; Pacemaker.
Description: Technical Summary
Cardiovascular disease (CVD) is likely to be a major cause of morbidity and mortality in homeless people, but few data exist to describe the burden of disease or the health care management of patients for CVD. This study aims to describe the epidemiology and healthcare resource use and the care pathway of CVD in homeless populations and to understand the changes which may be necessary to improve treatment and prevention of CVD.
Codes for homelessness in primary care data linked with secondary care data will be assessed and evaluated. The completeness and quality of data regarding CVD will be evaluated. If quality and completeness of data permit,incidence, prevalence and outcomes will be estimated for CVD in homeless individuals. Prevalence will be measured as a proportion of the homeless population. Incidence and service utilisation (e.g. rates of coronary artery bypass surgery) will be measured as a rate with person-years as the denominator. We will develop a prediction model to predict future burden using regression methods including negative binomial regression modelling.
Data visualisation tools will be used to describe patient care pathways and service use within 1 year after a CVD initial patient care pathway/healthcare utilisation (6 and 12 months).
The effectiveness of different health care management experienced by patients will be measured through the evaluation of patients prognosis. Survival analysis models, Kaplan-Meier plots and Poisson regression will be used to assess the prognosis of patients will be used to evaluate their effectiveness.
Existing cardiovascular risk prediction models (e.g. QRISK2) will be validated and calibrated in homelessness people. The need for and feasibility of new risk prediction tools in this specific population will be explored using regression.
Source -
Understanding the Relationship between Multimorbidity in Later Life, Use of Health Services and Costs of Health Care (MuSeCol) — Raphael Wittenberg ...
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Understanding the Relationship between Multimorbidity in Later Life, Use of Health Services and Costs of Health Care (MuSeCol)
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
Raphael Wittenberg - Chief Investigator - University of Oxford
Catia Nicodemo - Corresponding Applicant - University of Oxford
Chris Salisbury - Collaborator - University of Bristol
Clare Bankhead - Collaborator - University of Oxford
Cynthia Wright Drakesmith - Collaborator - University of Oxford
Kamal Mahtani - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Peter Bower - Collaborator - University of Manchester
Rafael Perera - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Robert Anderson - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of Oxford
Stuart Redding - Collaborator - University of OxfordOutcomes:
1. Numbers of chronic conditions (co-morbidities)
2. Utilisation of health services, i.e. number of GP consultations, A&E attendances, hospital admissions etc.
3. Costs of primary and secondary health care received, to be calculated from utilisation data
4. Annual probabilities of transition between morbidity categories defined by number of health conditions, to be analysed as a function of the personÂs current number of health conditions, age, gender, deprivation of area of residence and diagnosis of dementia or depressionDescription: Technical Summary
The aim of the study is to understand how use of health services by middle-aged and older people (aged 50 and over), and the associated costs of health care, rise with each additional health condition. This is intended to help the NHS to target resources toward those patients who are most likely to have high use of services in future due to multimorbidity.
We will conduct multi-variate analyses of a CPRD data sample to examine the relationship between health care utilisation in primary and secondary care and the number of health conditions (comorbidities) controlling for patient age, gender and deprivation (IMD) of area of residence.
Costs of health care services utilised by patients will include the cost of primary and secondary services they receive. We will use data on costs from the NHS Reference Costs and the PSSRU Unit Cost reports (Curtis and Burns).
From this analysis we will develop a Markov model, using our estimated transition rates and estimated costs of care by number of health conditions, to estimate expected lifetime costs of care from age 50 upward. This information will be made available via a user-friendly tool published on a website.
Prevalence estimates of common co-morbidities by geographical region were used from this project to comment on the possible impact of Covid-19 during the 2020 pandemic.
Source -
Incidence of major adverse cardiovascular and cerebrovascular events (MACE) in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis: a retrospective analysis of a United Kingdom database — Paola Primatesta ...
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Incidence of major adverse cardiovascular and cerebrovascular events (MACE) in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis: a retrospective analysis of a United Kingdom database
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-29
Organisations:
Paola Primatesta - Chief Investigator - Novartis Pharma AG
Paul McGettigan - Corresponding Applicant - Novartis Ireland Limited
Brendan Lynch - Collaborator - Novartis Ireland Limited
Madison Brown - Collaborator - Novartis Ireland Limited
Shiwani Prasad - Collaborator - Novartis Healthcare (India) Pvt. Ltd.
Shreya Banerjee - Collaborator - Novartis Healthcare (India) Pvt. Ltd.
Sibasish Saha - Collaborator - Novartis Pharma AG
Valentine Jehl - Collaborator - Novartis Pharma AGOutcomes:
The outcome of interest in this analysis is any MACE, defined as a composite end-point of myocardial infarction, stroke and cardiovascular death. Read codes and ICD-10 codes for these events are provided in Appendix B.
Description: Technical Summary
Objectives:
Population epidemiological studies suggest that patients with psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS) may have increased risk of cardiovascular and cerebrovascular disease compared with the general population of the same age and gender (Bengtsson et al., 2017, Keller et al., 2014, Szabo et al., 2011). Secukinumab (Cosentyx) is a recently approved drug developed to treat psoriasis, PsA and AS. To confirm whether Secukinumab affects the rate of stroke or heart attack in patients with these conditions we need to determine the background rates of these events in the disease population..Periodic Safety Update Reports (PSURs) are reports submitted annually to Health Authorities to update the efficacy/effectiveness and safety profile of newly approved drugs.. The data from the Secukinumab clinical trials regarding important identified and potential risks are presented in these PSURs. Major adverse cardiovascular and cerebrovascular events (MACE) is one of the important potential risks, and as such it is important to contextualize the data obtained from the clinical trials, with background rates from the population with the disease.
We will use the Clinical Practice Research Datalink (CPRD) linked to national hospital episode statistics (HES) and mortality statistics (ONS) to estimate the rates of major adverse cardiovascular and cerebrovascular events (- or MACE) among the psoriasis, PsA and AS patient population.
Methods:
Incidence of MACE will be calculated as the number of new cases per 100 persons at risk (incidence proportion) and as the number of new cases per 1,000 person-years at risk (incidence rate). Confidence intervals for both incidence proportions and incidence rates will be computed. Incidence estimates with confidence intervals will be computed separately for each combination of age and sex.Data analysis:
Patients recorded with diagnoses of psoriasis, PsA or AS between 1 January 1998 and 30 June 2017 (inclusive) will be used.NB this ISAC corresponds to a re-run of the described analysis wherein which alterations have been made to the SAP. The resubmission of this ISAC was necessary as the original data was destroyed as per policy.
Source -
Epidemiology of Valvular Heart Disease in Epilepsy Patients — Ahinee Amamoo ...
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Epidemiology of Valvular Heart Disease in Epilepsy Patients
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-14
Organisations:
Ahinee Amamoo - Chief Investigator - UCB Pharma GmbH
Ahinee Amamoo - Corresponding Applicant - UCB Pharma GmbH
John Logan - Collaborator - UCB Pharma SA - UK
Nada Boudiaf - Collaborator - UCB BioSciences, Inc.
Nadia Foskett - Collaborator - UCB BioSciences, Inc.
Victor Kiri - Collaborator - UCB BioSciences, Inc.Outcomes:
Valvular Heart Disease
Description: Technical Summary
This will be a descriptive, exploratory cohort study that will examine the incidence of valvular heart disease among newly diagnosed epilepsy patients, drug-resistant epilepsy patients and patients without epilepsy in real-life clinical practices from the UK Clinical Practice Research Datalink (CPRD). Patients for each study population will be selected from patients with records available between 01-Jan-2006 and the last date available. All study participants are required to have at least two years of medical record with at least one year of data prior to the index date. Newly diagnosed patients will be included if they have a diagnosis of epilepsy or a record of an AED and at least 2 seizure diagnoses. Drug resistant patients will be included if have at least one prior epilepsy diagnosis and 5 AED attempts. Patients without epilepsy will be selected from the set of patients at the same practice as epilepsy patients. All patients will be excluded if they have a record of valvular heart disease prior to index date . Incidence of valvular heart disease will be explored overall and within age and gender. The outcome will be analysed using Poisson regression models or the negative binomial models (if there is over dispersion)
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Identifying predictors of drug treatment response in bipolar disorder — Joseph Hayes ...
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Identifying predictors of drug treatment response in bipolar disorder
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-17
Organisations:
Joseph Hayes - Chief Investigator - University College London ( UCL )
Joseph Hayes - Corresponding Applicant - University College London ( UCL )
Christina Dalman - Collaborator - Karolinska Institute Sweden
David Osborn - Collaborator - University College London ( UCL )
Emma Francis - Collaborator - University College London ( UCL )
Fehmi Ben Abdesslem - Collaborator - University College London ( UCL )
Gareth Ambler - Collaborator - University College London ( UCL )
Glyn Lewis - Collaborator - University College London ( UCL )
Ian Wong - Collaborator - UCL School Of Pharmacy
Irene Petersen - Collaborator - University College London ( UCL )
John Geddes - Collaborator - University of Oxford
Kate Walters - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Magnus Boman - Collaborator - KTH Royal Institute of Technology
Mihaela van der Schaar - Collaborator - University of Oxford
Rumana Omar - Collaborator - University College London ( UCL )
Sarah Hardoon - Collaborator - University College London ( UCL )Outcomes:
Treatment response defined as:
1. Time to hospitalisation
2. Time to change in treatmentRenal Failure defined as:
1. Categories of chronic kidney disease
2. Trajectories of estimated glomerular filtration rateWeight change defined as:
1. Percentage weight change
2. Trajectory of body mass indexDescription: Technical Summary
AIMS
To personalise prescribing for people with bipolar disorder via prediction models that quantify the potential benefits and risks of existing treatments based on phenotypic characteristics of the individual.OBJECTIVES
1. Identify early, individualised clinical predictors of lithium and second-generation antipsychotic response
2. Determine clinical predictors of renal failure in individuals taking lithium
3. Determine clinical predictors of pathological weight gain in individuals taking second-generation antipsychotic medication
4. Identify predictors of early tolerability issues related to lithium and second-generation antipsychotic medicationMETHODOLOGY
We will complete analyses using standard epidemiological methods (penalised Cox proportional hazards regression with exploration of suitable variable selection approaches such as Lasso) and machine learning methods (such as multi-task Gaussian process prediction), drawing on the strengths of each approach.
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Fractured wrist; predictors of poor long-term clinical and socioeconomic outcomes (The FILTER Study) — Danielle van der Windt ...
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Fractured wrist; predictors of poor long-term clinical and socioeconomic outcomes (The FILTER Study)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-29
Organisations:
Danielle van der Windt - Chief Investigator - Keele University
Milica Bucknall - Corresponding Applicant - Keele University
Claire Burton - Collaborator - Keele University
John Edwards - Collaborator - Keele University
Opeyemi Babatunde - Collaborator - Keele University
Stephen Gwilym - Collaborator - Oxford University Hospitals
Victoria Jansen - Collaborator - NHS England
Zoe Paskins - Collaborator - Keele UniversityOutcomes:
Decline in function using electronic frailty index (eFI)1; Healthcare utilization; Complications in primary or secondary care; Non-wrist fragility fracture; All-cause mortality
Description: Technical Summary
Each year approximately 78,000 people in the UK aged over 50 experience a fragility fracture of the wrist. Many of these fractures occur in individuals who are functionally independent, active, and with good health-related quality of life. Existing research has largely investigated consequences of wrist fractures in older populations and often with a focus on pain and hand disability, falls and future fractures. Yet, an estimated 20% of patients with wrist fracture are thought to develop functional decline, frailty, with consequent increased use of healthcare.
Understanding the extent and burden of these long-term consequences and the prognostic factors that identify those at high risk is essential to select subgroups likely to benefit from early, targeted interventions.In order to provide high quality evidence on prognosis and inform the design of future intervention studies, we propose to conduct a study using anonymised medical record data from a large, national primary care database, to investigate the burden and long-term impact of wrist fractures to patients and the NHS. This study will assess: i) long-term consequences in individuals aged >/=50 years, who are often still working at the time of fracture; ii) trajectories towards frailty and increased healthcare use which are essential to inform the long-term primary care management of patients post fracture, and iii) predictors associated with unfavourable outcomes.
Subsequent work will use these findings to design and evaluate a brief screening tool to assess patients at the time of fracture, for use in a future randomised trial evaluating the clinical/cost-effectiveness of targeted interventions for those at risk of poor outcomes.
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Recording of anxiety diagnoses and symptoms in primary care and trends in prescribing for anxiety — Nicola Wiles ...
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Recording of anxiety diagnoses and symptoms in primary care and trends in prescribing for anxiety
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-17
Organisations:
Nicola Wiles - Chief Investigator - University of Bristol
Charlotte Archer - Corresponding Applicant - University of Bristol
Becky Mars - Collaborator - University of Bristol
David Kessler - Collaborator - University of Bristol
Katrina Turner - Collaborator - University of BristolOutcomes:
This project will explore trends in anxiety diagnoses and symptoms over time, and trends in medication prescribed for anxiety (antidepressants [SSRIs, SNRIs, TCAs, MAOIs], benzodiazepines, anticonvulsants [pregabalin, gabapentine], antipsychotics [quetiapine], beta blockers [propranol]), in the UK between 2003 and 2018.
Description: Technical Summary
This study will investigate trends in anxiety symptoms and diagnoses, and trends in prescribing for anxiety, in the UK between 2003 and 2018, and examine associated factors. The study will use a retrospective cohort design, including patients aged 18 or over in CPRD who have an anxiety code between 1st January 2003 and 31st December 2018. The number of patients with a new episode defined by a symptom code or a diagnosis code in each calendar year will be calculated. In addition, the number of patients who received at least one prescription for anxiolytic medication, and the number of patients who started such medication in each calendar year will be calculated. Person-years at risk will be used as the denominator. Incidence rates and 95%CI will be calculated using Poisson regression. Data will be plotted to examine patterns of prescribing over time for all medications combined, and separately by drug class (antidepressants, benzodiazepines, anticonvulsants, antipsychotics, beta blockers). Changes in trends over time will be examined using join point regression. Data will be stratified by age/sex. We will also calculate the average treatment duration for incident cases to examine whether there have been changes in long-term prescribing.
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Characterizing type 2 diabetes mellitus (T2DM) patients trajectories and health outcomes - understanding and predicting co-morbidities, risk factors and complications — Yves Moreau ...
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Characterizing type 2 diabetes mellitus (T2DM) patients trajectories and health outcomes - understanding and predicting co-morbidities, risk factors and complications
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-24
Organisations:
Yves Moreau - Chief Investigator - KU Leuven University
Marc Twagirumukiza - Corresponding Applicant - Janssen Pharmaceutica NV
Edward de Brouwer - Collaborator - KU Leuven University
Ãkos Tonkol - Collaborator - Janssen Pharmaceutica NVOutcomes:
ÂLower limb complications of T2DM (list of codes is detailed in the appendix at the end of this protocol)
ÂDiabetic kidney disease (DKD)Description: Technical Summary
CPRD is a large primary care database, containing anonymized primary care patient data in UK. Those data can be analysed to build disease progression models that can provide insights to disease trajectories (i.e., the sequence of medical events observed in individual patients) and therefore help physicians to better manage the patientÂs disease. The study will therefore provide insights in tertiary disease prevention, a novel but increasingly prominent domain in healthcare.
This research aims to analyse patient cohort patterns, comparing the traditional statistical methods versus more novel machine learning approaches that uses the links/relationship between patients characteristics or medical events with predictive capabilities based on the patient trajectory data modelling.
In the first step we will apply descriptive and analytical statistical methods including univariate analysis and multivariate analysis with binary logistic regression, latent class analysis (latent growth mixture models) to characterize risk factors and outcomes. In the next step we propose a longitudinal Bayesian tensor factorization approach that relies on the Bayesian probabilistic matrix factorization framework (BPMF), a scalable approach with the ability to joint-model times to events and longitudinal data in two ways including (1) the extensions of methods for matrix factorization to allow the joint handling of time-dependent mixed type data and (2) the new extensions of deep learning algorithms, such as Long Short-Term Memory (LSTM), with appropriate modifications.
The two models will deliver two main insights on the analysis of interactions between different variables (including the risk factors identified by the first step of statistical analysis) and a prognosis for patients.
Source - and 18 more projects — click to show
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REPEAT: Study 21 - Replication of ÂManaging glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomes — Shirley Wang ...
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REPEAT: Study 21 - Replication of ÂManaging glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomesÂ
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Shirley Wang - Corresponding Applicant - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Incidence rate ratio for MACE for metformin +DPP-4 inhibitors vs. metformin +SU defined as the composite of stroke and MI (see appendix for READ codes).
Description: Technical Summary
This objective of this protocol is to replicate the study: ÂManaging glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomes by Gordon et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Gordon paper compared the rate for major adverse cardiovascular events (MACE) in patients with type 2 diabetes who were on metformin and initiated second-line therapy with DPP-4 inhibitors versus sulfonylureas (SU) between 2008 and 2014. We will focus on replicating the multivariate adjusted incidence rate ratio. Patients were required to have at least 12 months of follow-up to be included in the total event rate analysis. Total event rates were analysed as unadjusted event incidence per 1000 person-years and in adjusted Poisson regression models.
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Measurement of dementia disease progression in primary care: a cohort study — Kelvin Jordan ...
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Measurement of dementia disease progression in primary care: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-23
Organisations:
Kelvin Jordan - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Athula Sumathipala - Collaborator - Keele University
Carolyn Chew-Graham - Collaborator - Keele University
James Bailey - Collaborator - Keele University
Kate Walters - Collaborator - University College London ( UCL )
Martin Frisher - Collaborator - Keele University
Michelle Marshall - Collaborator - Keele University
Nwe Thein - Collaborator - Midlands Partnership NHS Foundation Trust
Paul Campbell - Collaborator - Keele University
Rashi Negi - Collaborator - Midlands Partnership NHS Foundation Trust
Richard Hayward - Collaborator - Keele University
Scott Weich - Collaborator - University of Sheffield
Swaran Singh - Collaborator - University of Warwick
Trishna Rathod-Mistry - Collaborator - Keele UniversityOutcomes:
All-cause mortality
All-cause hospital admission
Nursing home admission
Palliative careDescription: Technical Summary
The UK government has prioritised early recognition and treatment of dementia, with goals to prolong independence, delay nursing home and hospital admissions, and reduce mortality. It is recognised that this strategy necessitates primary care involvement in diagnosis and management of dementia. Whilst there is established research on case finding and diagnostics in dementia within primary care, there is a lack of research on the course and prognosis of dementia post-diagnosis. Such information, and what markers alter the course of the disease, is essential for patient management.
Potential resources for studying these issues in primary care are Electronic Health Record (EHR) databases. There are already ways to capture Âhard endpoints for this population including all-cause mortality, all-cause hospital admissions, and nursing home admissions. The challenge in using EHR for research on dementia is the need to identify, within records, discrete markers of disease progression toward these endpoints for patients with dementia. Evidence exists on what some of these markers may be (e.g. cognitive status, neuropsychiatric symptoms), but what is not known is whether these markers can be reliably detected using EHR.
This study will test the feasibility of establishing markers of disease progression using EHR databases among patients with dementia. We will establish an incident cohort of dementia patients and determine the frequency of recording of markers after diagnosis. We will use latent transition analysis to group patients based on their trajectories of progression over time from diagnosis using these markers. We will investigate prognostic factors for poor trajectories and the relationship of poor trajectories to Âhard endpoints such as mortality and hospital admission. The novel outputs (validated disease progression markers, mapping of dementia course, defined prognostic factors) will have direct benefits for people with dementia (e.g. identification of patients at risk of progression) and their primary care management.
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Effectiveness of long acting muscarinic-antagonist- (LAMA) as an add-on to inhaled corticosteroids / long acting beta-agonists (LABA) in smoking asthmatics — Emil Loefroth ...
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Effectiveness of long acting muscarinic-antagonist- (LAMA) as an add-on to inhaled corticosteroids / long acting beta-agonists (LABA) in smoking asthmatics
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-17
Organisations:
Emil Loefroth - Chief Investigator - NOVARTIS
Amy Cole - Corresponding Applicant - Novartis Ireland Limited
Himanshu Pradhan - Collaborator - Novartis Pharma AG
Hui Cao - Collaborator - NOVARTIS
Jessica Marvel - Collaborator - Novartis Pharmaceuticals Corporation
Martin McSharry - Collaborator - Optum
Sibasish Saha - Collaborator - Novartis Pharma AGOutcomes:
The annualized rate of exacerbation among smoking asthmatics in two cohorts and between subgroups of these cohorts.
The time to first exacerbation in smoking asthmatics in two cohorts and between subgroups of these cohorts
Health Care Resource Utilization (HCRU) in the two cohorts.
SABA use in the two cohorts in the follow-up period.Description: Technical Summary
The primary Objective is to compare the annualized rate of exacerbation among smoking asthmatics in two cohorts. Cohort I: Patients who had LAMA add-on to FD ICS/LABA and Cohort II: Matched patients who remained on the ICS/LABA regimen. Treatment failure will be defined as increased treatment dose, prescription of additional maintenance therapy, episode of moderate or severe asthma exacerbation or excessive use of short acting beta agonists (SABA).
The secondary objectives are to: compare time to exacerbation and annualized rate of exacerbations between medium or high dose ICS/LABA vs medium or high dose ICS/LABA + LAMA add-on; describe the asthma related and all-cause health care resource utilization (HCRU) in the two cohorts; describe SABA use in the two cohorts in the follow-up period.
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BurDeN Study: Incidence and Burden of Disease from Shingles and Post-Herpetic Neuralgia in the over 80 year olds in the UK — Ian Matthews ...
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BurDeN Study: Incidence and Burden of Disease from Shingles and Post-Herpetic Neuralgia in the over 80 year olds in the UK
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Admitted Patient Care; HES Outpatient; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-02
Organisations:
Ian Matthews - Chief Investigator - Merck Sharp & Dohme - UK
Vicky Parsons - Corresponding Applicant - OXON Epidemiology - Spain
Ana Filipa Macedo - Collaborator - OXON Epidemiology - Spain
Bayad Nozad - Collaborator - Merck Sharp & Dohme - UK
Boriana Guimicheva - Collaborator - Merck Sharp & Dohme - UK
Mai Duong - Collaborator - Evidera, Inc
Rosie Barnett - Collaborator - OXON Epidemiology - Spain
Sophie Wilding - Collaborator - Merck Sharp & Dohme - UK
Trusha Patel - Collaborator - Merck Sharp & Dohme - UK
Yash Patel - Collaborator - Merck Sharp & Dohme - UKOutcomes:
Rate of herpes zoster; rate of post-herpetic neuralgia; healthcare resources utilised; number of individuals who have lost eligibility for herpes zoster vaccination; national preventable disease burden.
Description: Technical Summary
Background: The UK herpes zoster (HZ) national immunisation programme currently covers individuals aged 70-79 years old. Research suggests a large proportion of ?80 year olds who were previously eligible may have missed out on vaccination, remaining at increased risk of disease. The most common complication of HZ is post-herpetic neuralgia (PHN), a chronic neuropathic pain condition that persists for 3 months or more following an outbreak of HZ. Most occurrences of HZ occur after the age of 50 and older individuals are more likely to develop PHN. However, there is currently a lack of published information on HZ among individuals aged over 80 years.
Objectives: This study will describe the epidemiological and economic burden of HZ and PHN in the immunocompetent UK population aged ?80 years unvaccinated against HZ. Number of individuals who lost eligibility for vaccination due to the 80-year cut-off will be quantified.
Methods: Individuals will be identified in Clinical Practice Research Datalink/Hospital Episode Statistics from 1st September 2013 (introduction of immunisation programme) until 6 months before end of available data. Descriptive statistics will be provided for rates of HZ, PHN and healthcare resource utilisation and number of individuals who have lost eligibility for HZ vaccination because of the 80-year cut-off. Rates will be applied to national population statistics to estimate national preventable disease burden in the UK.
Importance: This study will provide information on the burden of HZ among ?80 year olds and support evaluations by relevant UK stakeholders considering the national HZ vaccination programme eligibility criteria.
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Comparing the characteristics between non-valvular atrial fibrillation patients who are treated or untreated with oral anticoagulants — Sreeram Ramagopalan ...
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Comparing the characteristics between non-valvular atrial fibrillation patients who are treated or untreated with oral anticoagulants
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-15
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Cormac Sammon - Corresponding Applicant - PHMR Associates
Elaine Stamp - Collaborator - PHMR Associates
Megan Besford - Collaborator - PHMR AssociatesOutcomes:
 Bleeding history/predisposition
 Liver disease
 Prescription of drugs predisposing to bleeding
 Modified HAS-BLED score
 Stroke/transient ischemic attack
 Systemic thromboembolism
 Congestive heart failure
 Vascular diseases
 Hypertension
 Diabetes
 CHAD2 score
 CHA2DS2-VASc score
 BMI
 Weight
 Cancer status
 Falls
 Deprivation (IMD)
 Paroxysmal NVAF
 DementiaDescription: Technical Summary
Objectives
To compare the clinical characteristics between patients treated or untreated with oral anticoagulants (OACs) who are newly diagnosed with non-valvular atrial fibrillation (NVAF).Methods
This will be a descriptive and exploratory population-based case-control study in patients who are newly diagnosed with NVAF. Patients with an incident NVAF will be identified from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) for a 5-year period between 2013 to 2017. Prescriptions with relevant OAC drug codes will be identified to classify individuals as OAC-treated (controls), and those remaining (i.e. without an OAC prescription) will be classed as OAC-untreated (cases).Data analysis
Appropriate descriptive statistics will be used to summarise relevant clinical characteristics (Section N). These will be categorised to reflect OAC treatment status. Subgroup analysis will be performed stratified by calendar year, in those with paroxysmal NVAF and in dementia patientsUnivariable and multivariable logistic regression models will be used to estimate odds ratios comparing the odds of each event between cases and controls.
Sensitivity analysis will include different pre-index follow-up time.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 14 - Replication of ÂCardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study — Jeremy Rassen ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 14 - Replication of ÂCardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort studyÂ
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-22
Organisations:
Jeremy Rassen - Chief Investigator - Aetion, Inc
Shirley Wang - Corresponding Applicant - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
CVD events and survival among individuals who attempted smoking cessation
Description: Technical Summary
This objective of this protocol is to replicate the study: ÂCardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study by Dollerup et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Dollerup paper evaluates cardiovascular events and survival among individuals who attempted smoking cessation with the support of NRT (nicotine replacement therapy) compared with those aided by smoking cessation advice only between 2000-2009. We will focus on replicating the outcome of ischemic heart disease (IHD) events in individuals who attempted smoking cessation over this time period. We will focus on replicating the baseline cohort characteristics and the adjusted hazard ratio for IHD using a Cox proportional hazards model.
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Comparative effectiveness of first line anti-hypertensive agents stratified by age and ethnicity — Sarah...
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Comparative effectiveness of first line anti-hypertensive agents stratified by age and ethnicity
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-21
Organisations:
Sarah-Jo Sinnott - Chief Investigator - Not from an Organisation
Sarah-Jo Sinnott - Corresponding Applicant - Not from an Organisation
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcome: Changes in systolic and diastolic blood pressure
Secondary outcomes: myocardial infarction and stroke
Adverse outcome: diabetes, gout, angioedema, fractures
Negative control outcome: Herpes ZosterDescription: Technical Summary
Hypertension is a leading cause of morbidity and mortality worldwide. Its increasing prevalence makes this cardiovascular risk factor a major threat to public health, however it is modifiable. Pharmacological therapy is a most effective intervention for lowering blood pressure and preventing cardiovascular events.
Current NICE guidance recommends, as first line therapy, calcium channel blockers in older patients (>55yrs) and black patients. If not tolerated, a diuretic is recommended. In younger patients (<55yrs), ace-inhibitors are advised. The ALLHAT trial is used to support ethnicity based recommendations but these data are limited by relying on secondary outcomes and multiple testing. Several clinical trials are cited to support age-based recommendations, many of which include small numbers, men only and short follow-up periods. Subgroup analyses according to age followed >/<65yrs cut offs.
We aim to use electronic health records from UK primary care to explore the comparative effectiveness of different first line anti-hypertensive agents, according to age, gender and ethnicity strata. Using mixed effects linear models and Cox regression we will compare new initiators of angiotensin converting enzyme inhibitors/angiotensin receptor blockers, calcium channel blockers and thiazide diuretics in terms of changes in blood pressure (primary outcome) and incidence of myocardial infarction and stroke (secondary outcomes). We will adjust for confounding using propensity scores.
The advantages of electronic health record data over traditional randomised clinical trial data include large numbers to support powered subgroup analyses and longer follow up periods to allow accumulation of clinical outcomes.
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Does aspirin affect the risk of cardiovascular events after pneumonia? — ...
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Does aspirin affect the risk of cardiovascular events after pneumonia?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
- Chief Investigator -
- Corresponding Applicant -
David Arnold - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Bristol
William Henley - Collaborator - University of ExeterOutcomes:
Primary: A composite of
1. Myocardial Infarction or
2. StrokeSecondary:
1. Mortality (all cause)
Description: Technical Summary
The study will involve a large cohort of older patients (>50 years old) with pneumonia, identified using the CPRD.
It is well established that pneumonia increases the risk of myocardial infarction (MI) and stroke, both in primary and secondary care datasets. Aspirin use has been shown to be protective in some clinical settings (such as secondary prevention of MI), but not beneficial in others.We will identify whether or not there is a protective effect of aspirin against MI and stroke in pneumonia using both traditional and novel statistical techniques: multiple variable logistic regression (our primary analysis, and our pre-specified data analysis) and a prior events rate ratio (PERR) analysis.
Our primary analysis will be a multivariable logistic regression, with aspirin use as a covariable. Other relevant confounders available in the CPRD will be included in this model. Alongside this, given the significant risks of confounding, we will perform a PERR analysis, a novel methodology involving self-control of cases within a dataset.
A PERR analysis adjusts for confounders by calculating an event rate prior to the time of diagnosis, and after the time of diagnosis, and comparing the two. In this analysis, we will identify all myocardial infarctions and strokes in the 6 months prior, and 6 months after the diagnosis of pneumonia. We will then compare the ratio of the Âprior events to the Âafter events in the patients who are taking aspirin as compared to patients not on aspirin.
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Are beta blockers beneficial or harmful in obstructive sleep apnoea? — Li Wei ...
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Are beta blockers beneficial or harmful in obstructive sleep apnoea?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
Li Wei - Chief Investigator - University College London ( UCL )
Li Wei - Corresponding Applicant - University College London ( UCL )
Allan Struthers - Collaborator - University of Dundee
Thomas MacDonald - Collaborator - University of DundeeOutcomes:
Sudden death
 Pacemaker insertion
 Myocardial infarction
 Heart failure
 Atrial fibrillation
 Cancer
 All-cause mortalityDescription: Technical Summary
Methods: This is a population-based cohort study using the Clinical Practice Research Datalink (CPRD) database. Patients with OSA who were prescribed at least two prescriptions of beta-blockers between 1986 and 2016 will form the exposure cohort. A propensity score matched cohort (1:2 matching) will be selected from patients who were not prescribed beta-blockers. The primary outcome will be sudden death during the follow up time. The secondary outcomes will include pacemaker insertion, myocardial infarction, heart failure, atrial fibrillation, cancer and all-cause mortality.
Data analysis: Cox proportional hazards regression models will be used to determine the association between the use of beta-blockers and the study outcomes. Univariate and multivariate analyses will be carried out. In the multivariate models the hazard ratios will be adjusted for all known covariates. The results will be expressed as hazards ratios and 95% confidence intervals. We will also perform a number of sensitivity analyses to address missing data and to make sure the results are robust.
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Inflammatory Skin Diseases and the Risk of Chronic Kidney Disease - Cross-sectional and Cohort Studies — Dorothea Nitsch ...
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Inflammatory Skin Diseases and the Risk of Chronic Kidney Disease - Cross-sectional and Cohort Studies
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-25
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yochai Schonmann - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary: Chronic kidney disease (CKD)
Secondary: CKD stage and renal replacement therapy (RRT)Overall we aim to explore the link between skin disease (exposure: atopic eczema, psoriasis, rosacea, and hidradenitis suppurativa) and kidney disease (outcome). However in practice, in Study A (case-control study) the exposure/outcome will be reversed, with CKD as exposure, and outcome as skin disease, while in Study B (cohort study) the exposure will be skin disease and the outcome(s) kidney disease.
(See detailed definitions in Section M below)Description: Technical Summary
We aim to explore the association between CKD and common non-communicable inflammatory skin diseases (i.e. atopic eczema, psoriasis, rosacea, hidradenitis suppurativa). The diagnosis of CKD requires evidence of an abnormally low estimated glomerular filtration rate (eGFR), but creatinine tests are not routinely offered or performed for everybody. However, we have shown that prevalent cases of CKD can be reliably ascertained through pooling accumulated test results over several years. Incident CKD can be accurately detected in at-risk populations, like those with diabetes, who undergo regular routine kidney function monitoring. We, therefore, plan to address our research question through two complementary study designs (1. prevalent case-control; 2. cohort) allowing us to assess both the magnitude and the temporal direction of the association between inflammatory skin diseases and CKD. We will define our main outcome, CKD, based on two consecutive reduced eGFR measurements, and we will apply previously validated algorithms where available to detect inflammatory skin diseases (i.e. the exposures). Initially, we will include all CPRD patients with prevalent CKD in March 2018 (each matched on GP practice, age and sex with up to 5 individuals without CKD) in a case-control analysis. We will fit conditional logistic regression models to compare the prevalence CKD among individuals with and without inflammatory skin diseases, and multinomial regression models to assess the association by CKD stage. Subsequently, we will conduct a cohort analysis, including all individuals in CPRD with diabetes (2004-2018). We will fit Poisson regression models to compare the rate of incident CKD among patients with and without atopic eczema and psoriasis. We will consider various lifestyle variables, medications, and recognised risk factors of CKD as potential confounders and/or mediators, and will employ a purposeful hierarchical approach to model building for a-priori covariate selection.
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The influence of the number of concomitant drugs used, on the safety and efficacy of NOACs compared to warfarin in patients with atrial fibrillation treated in routine care — Hendrika van den Ham ...
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The influence of the number of concomitant drugs used, on the safety and efficacy of NOACs compared to warfarin in patients with atrial fibrillation treated in routine care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
Hendrika van den Ham - Chief Investigator - Utrecht University
Carline van den Dries - Corresponding Applicant - University Medical Centre Utrecht
Arno W Hoes - Collaborator - Maastricht University
Carl Moons - Collaborator - University Medical Centre Utrecht
Frans Rutten - Collaborator - University Medical Centre Utrecht
Geert-Jan Geersing - Collaborator - University Medical Centre Utrecht
Helga Gardarsdottir - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Romin Pajouheshnia - Collaborator - Utrecht University
Sander van Doorn - Collaborator - University Medical Centre UtrechtOutcomes:
Major bleeding
- Stroke (both ischemic and haemorrhagic)
- Clinically relevant non-major bleeding
- Mortality
- Gastro-intestinal bleeding
- HospitalizationDescription: Technical Summary
With this retrospective cohort study, we want to investigate the influence of the number of concomitant drugs used, on the safety and efficacy of NOACs versus warfarin treatment. Patients diagnosed with AF and initiating a NOAC or warfarin between 2010 and 2018 will be included from the UK CPRD. The relative hazards for the different NOACs versus warfarin on the outcomes major bleeding, ischemic stroke and mortality will be quantified using a Cox Proportional Hazard Model. The influence of the number of concomitant drugs used on these outcomes is assessed by including this as an interaction term in the model. Furthermore, we will assess predictor variables for bleeding in patients treated with a NOAC, by validating, and if necessary, updating existing prediction models for bleeding risk. As the time period prior to the occurrence of bleeding is of our particular interest, we will investigate the association between changes in (modifiable) risk factors and bleeding, shortly before the bleeding occurs. Finally, we want to compare the occurrence of bleeding and stroke in patients with an off-label NOAC dose reduction, to patients with an on-label dosage, applying propensity scores to evaluate if the off-label dose reduction was indeed unjustified or not.
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Improving treatment of people with dementia and additional health conditions — Joao Delgado ...
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Improving treatment of people with dementia and additional health conditions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-29
Organisations:
Joao Delgado - Chief Investigator - University of Exeter
Joao Delgado - Corresponding Applicant - University of Exeter
Clive Ballard - Collaborator - University of Exeter
David Melzer - Collaborator - University of Exeter
Jose M Valderas - Collaborator - University of Exeter
Linda Clare - Collaborator - University of ExeterOutcomes:
The list of outcomes to be measured in the study are:
1. Prevalence of comorbidities of dementia. The list includes Asthma, Atrial Fibrillation, Cancer, Coronary Heart Disease, Chronic Kidney Disease (Stages 3 to 5), COPD, Depression, Diabetes type 2, Epilepsy, Heart Failure, Hypertension, Hypothyroidism, Mental Health, Stroke (medcodes and ICD10 codes defined in ISAC protocol 14_135).
It also includes conditions included the electronic Frailty Index: i.e. Activity limitation, Anaemia and haematinic deficiency, Arthritis, Dizziness, Dyspnoea, Falls, Foot problems, Fragility fracture, Hearing impairment, Heart valve disease, Housebound, Hypotension/syncope, Mobility and transfer problems, Osteoporosis, Parkinsonism and tremor, Peptic ulcer, Peripheral vascular disease, Requirement for care, Respiratory disease, Skin ulcer, Sleep disturbance, Social vulnerability, Thyroid disease, Urinary incontinence, Urinary system disease, Visual impairment, Weight loss and anorexia.2. Potential inappropriate prescribing as defined by the STOPP/START criteria: focusing only on the STOPP portion as operationalised into CPRD by Bradley et al.(2014).
3. Characterisation of continuity of care in primary care as defined by the: Usual Provider Continuity (UPC) Index; Continuity of Care Index; and Modified Continuity Index (MMCI).
4. Geriatric outcomes: all-cause mortality, incontinence, falls, fractures, delirium or emergency hospital admissions for conditions possibly related to the prescriptions e.g. electrolyte imbalances. Major GO will be identified as a combination of medcodes, ICD10 and when applicable OPCS codes (e.g. fragility fractures). We will use as preliminary code lists, lists from our previous work with CPRD (ISAC protocols 14_135 (R), 14_159R2, 15_192R). These have been checked against CPRD 2018 medcode list and updated where new relevant codes were available (ANNEX 1).
Description: Technical Summary
In a preliminary analysis of electronic medical records from 598,631 older individuals we found that 92% of people with dementia had comorbidities. Co-morbidities often complicate care decisions by GPs, with high rates of potentially inappropriate prescribing (PIP, according to STOPP-START criteria) or under-treatment (which have been reported in people with dementia). This project will help quantify the scope for improving management of co-existing conditions for people with dementia in primary care. It includes the following phases:
Phase 1: Comorbidity, PIP and continuity of care
- Cross sectional design  Analysis of co-morbidities of dementia. Latent class analysis (LCA) identifying patterns of comorbidities based on chronic conditions and indicators of frailty in old age.
- Cross sectional design  Prevalence of potential inappropriate prescription (PIP) as defined by the STOPP-START criteria.
- Cross sectional design  Characterizing Continuity of Care (COC) with dementia.Phase 2: Impact of care quality on incidence rate of mortality and geriatric outcomes
- Longitudinal design  Estimating the association between a health care quality: PIP (presence/absence) and COC (e.g. quintiles), and the incidence rates of all-cause mortality and major geriatric outcomes.High quality treatment of comorbidities alongside dementia is critical for achieving the best outcomes for patients and caregivers. Findings from this fellowship will provide the foundation for future interventions to improve medication management.
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Dose adjustment or discontinuous use of direct oral anticoagulants related to the concurrent use of potential interacting drugs — Anthonius de Boer ...
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Dose adjustment or discontinuous use of direct oral anticoagulants related to the concurrent use of potential interacting drugs
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-17
Organisations:
Anthonius de Boer - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Yumao Zhang - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes:
Dose adjustment, Discontinuation and switching
Description: Technical Summary
Background:
Prescription patterns of direct oral anticoagulants (DOACs) are largely unknow before and during the concurrent use of interacting drugs. Compliance with labelling information is essential for the effective and safety use of DOACs.Objective
This population-based descriptive study will assess prescribing patterns, including dosing adjustment, and discontinuation among DOACs users with concurrent use of interacting drugs.Methods
A descriptive study will be conducted by using a cohort of DOAC users from the Clinical Practice Research Datalink (CPRD) data. The study period extends from 2008 to 2015. All patients 18+ years of age with first prescription of dabigatran, apixaban, and rivaroxaban are eligible. The number and proportion of dosing adjustment, or discontinuous use of DOACs during the initiation of concurrent use of potentially interacting drugs will be determined.
Data analysis
Descriptive statistics will be applied including frequencies and percentages. Number and percentage of DOACs users with dosing adjustment, or discontinuous use will be calculated.
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C-reactive protein as a biomarker of response to inhaled corticosteroids in COPD — Frank de Vries ...
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C-reactive protein as a biomarker of response to inhaled corticosteroids in COPD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-24
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Anthonius de Boer - Collaborator - Utrecht University
Frits Franssen - Collaborator - CIRO
Johanna Driessen - Collaborator - Utrecht University
Miel (Emiel) Wouters - Collaborator - CIRO
Olorunfemi Oshagbemi - Collaborator - Utrecht UniversityOutcomes:
Primary outcome:
Moderate-to-severe exacerbationsSecondary outcomes
severe exacerbations and all-cause mortality.We thank the reviewer for this suggestion. We have now included the following Â
The primary outcome of interest will be moderate-to-severe exacerbations, which will be defined by validated read codes (H312200, H3y1.00) for an acute exacerbation from the clinical and referral files [1] which has a positive predictive value (PPV) of 96.0% and a sensitivity of 25.1% in identifying acute exacerbations. . The secondary outcome included severe exacerbations, defined as a COPD-related hospitalizations/A&E visit using thread codes (8H2R.00, 66Yi.00) from either the clinical or referral files or the read codes (H312200, H3y1.00) for acute exacerbations from the referral file. We also evaluate the risk of all-cause mortality. Referral files contain referral details recorded by GPs while the clinical file contains all the medical history data entered by the GP [2].ÂDescription: Technical Summary
Chronic obstructive pulmonary disease (COPD) is a medical condition characterized by enhanced airway inflammation and is known to be responsible for mortality and morbidity of millions of individuals worldwide. C-reactive protein have also been identified to be elevated in patients with COPD exacerbation. Exacerbations of COPD are the primary outcome as these greatly affect a patients' quality of life. The benefits of inhaled corticosteroids (ICS) to reduce exacerbations have mainly been observed in patients having elevated CRP levels. More recently, a randomized open-label study among COPD patients found that after 6 weeks of treatment with ICS/long-acting beta-2 agonists CRP levels decreased. Therefore, the aim of this study will be to evaluate the risk of moderate-to-severe exacerbations, severe exacerbations and all-cause mortality with among COPD patients currently exposed to ICS stratified by CRP tertiles compared to ICS naive COPD patients with lowest CRP tertile. This study will be a cohort study of COPD patients aged 40 years or more from January 2005 to January 2014. Patients with CRP measurement at baseline will be included in the study. The primary outcome of the study will be a moderate exacerbation (secondary outcomes include: severe exacerbations or death). We will evaluate the risk of study outcomes stratified by ICS exposure. Current ICS users and ICS naive patients will be stratified by CRP tertiles using Cox regression analysis (SAS 9.4).
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Life-Limiting Conditions: the health of children and their Mothers — Lorna K Fraser ...
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Life-Limiting Conditions: the health of children and their Mothers
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-22
Organisations:
Lorna K Fraser - Chief Investigator - University of York
Lorna K Fraser - Corresponding Applicant - University of York
Catherine Hewitt - Collaborator - University of York
Fliss Murtagh - Collaborator - Hull York Medical School
Mary Barker - Collaborator - University of York
Simon Gilbody - Collaborator - University of YorkOutcomes:
Workpackage 1: Focus on Mothers
 Maternal mental health diagnoses, including both common mental illness and severe mental illness. These will be identified using diagnostic READ codes and relevant prescription data. A previously developed READ
code algorithm [1] will be utilised. The linked MHMDS will identify more serious mental health conditions.
 Maternal physical diagnoses, including e.g. obesity, hypertension, musculoskeletal problems, and cardiovascular disease. These will be identified using diagnostic READ codes, relevant prescription data, HES data, and related biometric data (including blood pressure, BMI, and total cholesterol).
 Referrals to other services, especially secondary services for mothers.
 Uptake of cervical screening by mothers.
 The number of primary care attendances (GP, practice nurse etc) per year by mothers
 The number and nature of prescribed medication for mothers.
 The number of A&E attendances, hospital admissions and length of stay for mothers.Workpackage 2 : Focus on Children
 Diagnosis of anxiety or depression in the children will be identified via diagnostic READ codes, prescription data and referral to relevant secondary and community services.
 The number of A&E attendances, primary care attendances (GP, practice nurse etc) per year by children.
 The number and nature of prescribed medication for children.
 The number of hospital admissions and length of stay for children.Description: Technical Summary
There are now nearly 50000 children with a life-limiting or life-threatening conditions (LLC) in the UK. These include conditions where there is no reasonable hope of cure and from which they will die, as well as conditions for which curative treatment may be feasible but can fail, e.g. cancer or heart failure. Having a child with a LLC involves being a coordinator and provider of healthcare in addition to the responsibilities and pressures of parenting a child who is expected to die young. This adversely affects the health and wellbeing of these mothers and affects their ability to care for their child, but the extent of the impact is poorly understood. The impact on the mental health of the children with a LLC, and the need for interventions, is also poorly understood.
Research Questions (RQs):
When compared to mothers of other children (WP1):
1. What is the nature and incidence of mental and physical morbidity in mothers of children with a life-limiting condition?
2. What is the relationship between the health of the mother and the child's condition?
3. What are the healthcare resource use for mothers of children with a LLC?When compared to other children (WP2):
4. What is the incidence of anxiety and depression in children and young people with a LLC?
5. What is the impact of maternal mental health on the mental health of the children with a LLC?
6. What clinical and demographic factors are associated with the incidence of anxiety and depression among children and young people with LLCs?
7. What is the healthcare resource use of children with a LLC?
Analyses :
Diagnostic codes will be used to identify the children with LLC, and chronic disease and the key outcomes in the CPRD and hospital datasets. Incidence rates and incidence rates ratios will be used to quantify and compare the outcomes between groups with multivariable regression modelling used for the other key RQs.
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The association between prescription opioids and risk of bone fracture: a self-controlled case series study using the Clinical Practice Research Datalink — Roger Knaggs ...
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The association between prescription opioids and risk of bone fracture: a self-controlled case series study using the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-21
Organisations:
Roger Knaggs - Chief Investigator - University of Nottingham
Emily Peach - Corresponding Applicant - University of Nottingham
Andrew Cooper - Collaborator - Mundipharma Research Ltd
Fiona Pearce - Collaborator - University of Nottingham
Janice Fuller - Collaborator - Mundipharma Research Ltd
Li-Chia Chen - Collaborator - University of ManchesterOutcomes:
Primary outcomes:
Bone fracture, anySecondary outcomes: Composite of fracture sites
Osteoporotic fracture; vertebral fracture; fragility fracture; non-vertebral fractureSecondary outcomes: ICD-10 fracture sites
Fractures of: multiple body regions; spine; upper limb; lower limb; skull and facial bones; neck; rib(s), sternum and thoracic spine; lumbar spine and pelvis; shoulder and upper arm; forearm; wrist and hand level; femur; hip; lower leg, including ankle; foot, except ankleDescription: Technical Summary
This self-controlled case series study aims to assess the association between prescription opioids and bone fracture using the CPRD GOLD (2009 to 2017) linking with HES. The objectives are to:
1. Quantify individual-level prescribing of opioids in a cohort of incident opioid users
2. Calculate the incidence rate of initial bone fracture outcomes in a cohort of incident opioid users
3. Evaluate the effect of current use, current and cumulative dose, and duration of opioid use on the risk of bone fracture in a cohort of incident opioid usersPatients initiating opioids between 2009 and 2017 will be followed to the occurrence of death, transfer out of the CPRD practice or the end of study. For each new opioid user, the duration and dose of each opioid prescription will be calculated. Their follow-up time will be categorised into periods of Âexposed time (from the prescription start date to the calculated prescription end date) and Âunexposed time (during which no opioid is prescribed).Daily dose for each exposed period will be calculated and converted to oral morphine equivalent dose (OMEQ).
Fracture outcomes will be identified from the CPRD and linked HES datasets. The association between prescription opioids and bone fracture will be assessed using self-controlled case series methodology; within-participant comparisons will be made between unexposed time, and exposed time, which will be split into Ârisk periodsÂ. Risk periods will be the: 1st week of opioid use, 2nd week of use, 3rd and 4th weeks of use, and remaining time of opioid use. Gaps in exposure following periods of opioid use will be classified as unexposed time, in addition to a one-year unexposed period, prior to opioid initiation.
Poisson regression with adjustment for time-varying covariates, will provide incidence rate ratios and corresponding 95%CIs for risk of fracture during these Ârisk periods compared to unexposed time.
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Guideline discordant diagnostic care: when do primary care referrals not reflect guidelines for suspected cancer? — Gary Abel ...
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Guideline discordant diagnostic care: when do primary care referrals not reflect guidelines for suspected cancer?
Datasets:GP data, HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2019-01-10
Organisations:
Gary Abel - Chief Investigator - University of Exeter
Gary Abel - Corresponding Applicant - University of Exeter
Bianca Wiering - Collaborator - University of Exeter
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
John Campbell - Collaborator - University of Exeter
William Hamilton - Collaborator - University of ExeterOutcomes:
Two week wait referral; Urinary tract infection treatment; Cancer diagnosis
Description: Technical Summary
In 2015, the National Institute for Health and Care Excellence (NICE) released updated guidelines for recognition and referral of suspected cancer in primary care, with the intention of increasing the proportion of cancer patients being diagnosed with early stage disease. However, guidelines are only effective to the degree that they are implemented. We will examine patients identified with any of the following symptoms during 2014 to 2016: haematuria, rectal bleeding, breast lump, post-menopausal bleeding, dysphagia and anaemia, to assess the extent to which symptom-based recommendations about referrals included in NICE guidelines are followed. The guidelines for these symptoms have remained largely unchanged in the updated guidelines. Patients are included whether or not they are subsequently diagnosed with cancer, reflecting that at initial presentation a diagnosis has not been made. It is important to examine guideline implementation among all patients for which urgent referral is mandated, not only those subsequently found to have cancer. Mixed effects models will be used to assess the variability in adherence to guidelines between patient groups, presenting symptoms and between practices/GPs. Haematuria in women will provide an exemplar condition, to examine how often apparent guideline discordance is justified by firm evidence of alternative diagnosis (urinary tract infection-related antibiotic prescription/retesting). Appreciating which patient groups are at greater risk of non-referral against guideline recommendations can help target improvement efforts.
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Evaluating a digital tool for supporting breast cancer patients: A prospective randomised controlled trial — The Royal Marsden NHS Foundation Trust...
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Evaluating a digital tool for supporting breast cancer patients: A prospective randomised controlled trial
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jan-19
Opt Outs: no information provided./p>
Organisations: The Royal Marsden NHS Foundation Trust
Description: Breast Cancer. NHS INNOVATE UK
Source
2018 - 12
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Mental illness: changes in incidence, prevalence, treatment and outcomes 2000-2018 — David Osborn ...
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Mental illness: changes in incidence, prevalence, treatment and outcomes 2000-2018
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
David Osborn - Chief Investigator - University College London ( UCL )
Joseph Hayes - Corresponding Applicant - University College London ( UCL )
Annie Jeffery - Collaborator - University College London ( UCL )
Antonio Lazzarino - Collaborator - University College London ( UCL )
Cini Bhanu - Collaborator - University College London ( UCL )
Eamon McCrory - Collaborator - University College London ( UCL )
Essi Viding - Collaborator - University College London ( UCL )
Francesca Solmi - Collaborator - University College London ( UCL )
Gabriele Price - Collaborator - Office for Health Improvement and Disparities
Graziella Favarato - Collaborator - University College London ( UCL )
Ian Wong - Collaborator - UCL School Of Pharmacy
Irene Petersen - Collaborator - University College London ( UCL )
Jennifer Dykxhoorn - Collaborator - University College London ( UCL )
Justin Yang - Collaborator - University College London ( UCL )
Kate Walters - Collaborator - University College London ( UCL )
Kenneth Man - Collaborator - University College London ( UCL )
Laura Scolamiero - Collaborator - University College London ( UCL )
Leiah Kirsh - Collaborator - University College London ( UCL )
Mariam Humayun - Collaborator - University College London ( UCL )
Michelle Eskinazi - Collaborator - University College London ( UCL )
Naomi Launders - Collaborator - University College London ( UCL )
Naomi Warne - Collaborator - University of Bristol
Rosalind McAlpine - Collaborator - University College London ( UCL )
Sarah Hardoon - Collaborator - University College London ( UCL )Outcomes:
 Incidence of:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disorders Prevalence of:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disorders Mortality rate in:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disorders Disease specific morbidity in:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disorders Receipt of drug treatment for:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disorders Hospital admissions in:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disorders Receipt of psychological treatment in:
schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, major depression, anxiety disorders, post-traumatic stress disorder, eating disorders, personality disordersDescription: Technical Summary
For each of schizophrenia, bipolar disorder, schizoaffective disorder, other non-organic psychotic illnesses, severe depression, anxiety disorders, post-traumatic stress disorder, eating disorders and personality disorders we will describe the trends in incidence, prevalence, all-cause and cause specific mortality, comorbidity, hospitalisation, drug and psychological therapy receipt from 2000 to 2018.
Incidence rate will be defined as the number of disease onsets/sum of person-time at risk, prevalence as the number of cases/population size. Mortality, cause specific mortality, comorbidity and cause specific morbidity rate will be calculated as the number of new events/sum of person-time at risk. Mortality, cause-specific mortality, comorbidity, cause-specific morbidity and hospitalisation rates compared to the general population will be described by hazard ratios calculated using adjusted Cox proportional hazards regression and incidence rate ratios using Poisson regression. Drug treatment and psychological therapy will be described as incident treatments and prevalent treatments. We will examine how psychotropic drug treatment affects health outcomes and hospitalisation by comparing exposed vs unexposed individuals and exposed vs unexposed time periods in the same individual.
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Evaluating the risk of macrovascular events, disability, and mortality in individuals with multiple sclerosis in England: a population-based retrospective cohort study — Jeremy Chataway ...
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Evaluating the risk of macrovascular events, disability, and mortality in individuals with multiple sclerosis in England: a population-based retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
Jeremy Chataway - Chief Investigator - University College London ( UCL )
Raffaele Palladino - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Ruth Anne Marrie - Collaborator - University of ManitobaOutcomes:
Acute coronary events (acute myocardial infarction, coronary artery disease, coronary revascularisation procedures)
- Cerebrovascular disease (haemorrhagic and ischaemic stroke)
- Use of cane
- Use o wheelchairDescription: Technical Summary
Cardiovascular risk assessment and management is important in individuals with multiple sclerosis (MS) considering they have high prevalence of cardiovascular risk factors, have increased risk of macrovascular complications, and cardiovascular risk factors are associated with more rapid disease progression and higher mortality.
This project aims to conduct a population-based retrospective cohort study of individuals with MS matched to controls by age, sex, and general practice to i) assess whether in the UK the risk of macrovascular events and cardiovascular mortality differs in individuals with MS as compared with the general population; ii) identify predictors of macrovascular events and disability in MS; iii) develop and validate a risk score to predict the risk of MS-related disability and macrovascular disease suitable for use in primary care settings.
Multivariable survival hazard models will be employed to assess whether incident rates of macrovascular events differ between individuals with MS and the control population. Specifically, for individuals with MS, a risk prediction algorithm will be developed for each of the following outcomes: occurrence of acute coronary events, occurrence of cerebrovascular events, use of cane, and use of wheelchair. Internal validation of the risk prediction algorithm will be performed using the k-fold method.
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Identifying population groups at risk of avoidable hospitalisations for community acquired pneumonia in the UK. — Julie George ...
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Identifying population groups at risk of avoidable hospitalisations for community acquired pneumonia in the UK.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
Julie George - Chief Investigator - University College London ( UCL )
Julie George - Corresponding Applicant - University College London ( UCL )
Ana Torralbo - Collaborator - University College London ( UCL )
Andrew Hayward - Collaborator - University College London ( UCL )
Carlos Andres Valencia-Hernandez - Collaborator - University College London ( UCL )
Dionisio Acosta Mena - Collaborator - University College London ( UCL )
Jennifer Quint - Collaborator - Imperial College London
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sonya Crowe - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Primary Outcome:
Unplanned hospitalisation (all cause)Secondary Outcomes:
Unplanned hospitalisation for community acquired lower respiratory tract infection / pneumonia; unplanned hospitalisation >7 days; unplanned hospitalisation > 21 days; unplanned hospitalisation for less than median length of stay; unplanned re-hospitalisation within 30 days; all-cause mortality within 30 days of unplanned hospitalisationDescription: Technical Summary
Study Objective: To identify and characterise discrete adult sub-populations at risk of unplanned hospitalisation following community acquired lower respiratory tract infection (CA-LRTI) in UK population using linked electronic health records to inform the development of group-oriented admission avoidance schemes.
Methods: We will use linked primary care data (CPRD GOLD), A&E and hospital admission data (HES) and mortality data (ONS) to identify sub-groups of patients with shared characteristics at risk of hospitalisation for CA-LRTI. We will predict this risk over three time intervals (6 months, 1 or 2 years) using as explanatory variables those describing patients' demographic, social and personal situation, frailty markers, health behaviours, biomarkers, co-morbidities, medication and immunisation status, healthcare utilisation and healthcare and area features. Once identified, we will describe the outcome of hospitalisations (length of stay, unplanned re-hospitalisation, mortality), prevalence, population attributable fraction, and costs of healthcare utilisation for each sub-group.
Data analysis: We will utilise decision-tree based supervised statistical learning methods to identify sub-groups at risk of hospitalisation and evaluate them in terms of accuracy and model interpretability. We will estimate the proportion of admitted patients with subsequent adverse outcomes for each subgroup. We will calculate the mean and median cost of hospitalisation for each sub-group, using the relevant NHS tariffs.
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A study using Observational Health Data Sciences and Informatics tools to characterize treatment pathways for stroke prevention in Atrial Fibrillation across diverse population settings (TxPath-AF) — Alex Asiimwe ...
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A study using Observational Health Data Sciences and Informatics tools to characterize treatment pathways for stroke prevention in Atrial Fibrillation across diverse population settings (TxPath-AF)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Alex Asiimwe - Chief Investigator - Bayer AG
Pareen Vora - Corresponding Applicant - Bayer AG
Beth Russell - Collaborator - Bayer AG
Gunnar Brobert - Collaborator - Bayer AGOutcomes:
Treatment pathways for stroke prevention in atrial fibrillation patients. This includes treatment type and switching patterns.
Description: Technical Summary
The AF treatment pathways study is a retrospective network study using Observational Medical Outcomes Partnership (OMOP) data sources available either internally (CCAE and MDCR from US, and CPRD from UK) or from a research collaborator in the OHDSI network. The intention of this study is to characterize treatment for stroke prevention of AF (SPAF) while accounting for database heterogeneity, population diversity and variance in care. The study population is patients taking antithrombotic agents for SPAF. The initial event is first time exposure to antithrombotic medication. The patients must at least a year of observation prior to the initial event. SPAF treatment prevalence is calculated following the tabulation generated by the database query (SQL code). A count of each unique treatment sequence is tabled from which the sunburst graphs will be created. Each data source will produce its own sunburst graph for SPAF treatment to see how treatment pathways vary by population, geography and data source type. Additionally, we will provide information on the temporal trends in SPAF treatment by stratifying results by year. This will enable us to assess any changes over time in SPAF treatment since the introduction of NOACs.
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Linaclotide Safety Study for the Assessment of Diarrhoea - Complications and Associated Risk Factors in the UK population with IBS-C — Javier Cid ...
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Linaclotide Safety Study for the Assessment of Diarrhoea - Complications and Associated Risk Factors in the UK population with IBS-C
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-17
Organisations:
Javier Cid - Chief Investigator - Evidera, Inc
Nafeesa Dhalwani - Corresponding Applicant - Evidera, Inc
Ahunna Ukah - Collaborator - Allergan, Inc
Anna Schultze - Collaborator - Evidera, Inc
Mireia Raluy Callado - Collaborator - Evidera, Inc
Robert Donaldson - Collaborator - Evidera, IncOutcomes:
SCD is the main outcome of interest and will be defined as diarrhoea (as documented by diagnostic codes) and subsequently (between the diarrhoea diagnosis date and 45 days afterwards) any of the following outcomes:
? Dehydration that requires intravenous rehydration
? Dehydration that requires oral rehydration with solutions of electrolytes
? Electrolyte imbalance: potassium (serum potassium levels 3.0Â3.5 mEq/L or <3.0 mEq/L) and sodium (serum sodium levels >150 mEq/L)
? Oliguria (urine output < 400 mL in 24 h)
? Anuria (urine output < 50 mL in 24 h)
? New-onset thromboembolism episodes
? New-onset orthostatic hypotension
? New-onset syncope
? New-onset dizziness
? New-onset vertigo
? Acute renal failure
? Hypovolemic shock
? Hospitalisation due to diarrhoea
? Stupor
? Coma
? Death
Read codes used to identify these conditions are provided in Appendix II. The definition will be validated through a GP questionnaire to estimate the positive predictive value of this definition.Description: Technical Summary
Irritable bowel syndrome (IBS) is a chronic, relapsing gastrointestinal condition characterised by abdominal pain, bloating, and changes in bowel habits. Prevalence estimations vary with the diagnostic criteria used, and in the United Kingdom (UK) were estimated between 9.5% and 22%. IBS can be classified according to Rome III criteria on the basis of the stool's characteristics: IBS predominantly with diarrhoea (IBS-D); IBS predominantly with constipation (IBS-C); and IBS with mixed bowel habits (IBS-M), with approximately one third of IBS patients having each type.
Linaclotide (Constella), a guanylate cyclase-C receptor agonist with visceral analgesic and secretory activities, was approved as the first medicine authorised for the symptomatic treatment of moderate-to-severe IBS-C in adults in the European Union (EU, and as a condition for approval the EMA requested a post-authorisation safety study to assess the risk of diarrhoeal complications in patients taking linaclotide.
This study plans to investigate the risk of developing severe complications of diarrhoea (SCD) during treatment with linaclotide among patients with IBS-C in the UK and to investigate what the risk factors for experiencing SCD are.
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Low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride and diverse non-cardiovascular diseases: a population-based cohort study of England using linkage dataset — Harry Hemingway ...
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Low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride and diverse non-cardiovascular diseases: a population-based cohort study of England using linkage dataset
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-14
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Nat Na-Ek - Corresponding Applicant - Farr Institute of Health Informatics Research
Amitava Banerjee - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Incidence of all-cause and cause-specific mortality and 12 non-cardiovascular diseases as follows: cataract, age-related macular degeneration (AMD), Alzheimerâs disease, Parkinsonâs disease, type 2 diabetes, cirrhosis, psoriasis, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, chronic obstructive pulmonary disease, and idiopathic pulmonary fibrosis.
Description: Technical Summary
Observational studies have shown that LDL-C, HDL-C, and TG levels might be associated with some autoimmune disorders and some idiosyncratic adverse events. Due to limitations of existing evidence, however, the role of blood lipids in non-cardiovascular diseases is still questioned. This observational study aims to examine the associations between LDL-C, HDL-C, TG, and the incidence of all-cause mortality, and of diverse non-cardiovascular diseases, including cataract, age-related macular degeneration, Alzheimerâs disease, Parkinsonâs disease, type 2 diabetes, cirrhosis, psoriasis, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, chronic obstructive pulmonary disease, and idiopathic pulmonary fibrosis. Use of linked-data from hospital and GP records will allow us to investigate the full spectrum of blood lipids levels. We will include the population without pre-existing disease of interest whose blood lipids measurement was available during 1998 to 2018, and we will follow them up until the first presentation of disease of interest, death, or transfer out of the practice, whichever occurred first. Hazard ratios of the incidence of disease for each unit change in blood lipids will be calculated using time-dependent Cox proportional hazard models adjusted for potential confounders. We will also examine the role of age, gender as effect modifiers. The findings of this study will allow the investigator to conduct further research to understand more about the role of blood lipids in non-cardiovascular diseases.
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Withdrawal of historical inhaled corticosteroids in primary care using electronic records — Ruth Farmer ...
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Withdrawal of historical inhaled corticosteroids in primary care using electronic records
Datasets:GP data, HES Admitted Patient Care; PAT IDs
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Ruth Farmer - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Ruth Farmer - Corresponding Applicant - Boehringer-Ingelheim Pharmaceuticals, Inc
Helen Ashdown - Collaborator - University of Oxford
James Chalmers - Collaborator - University of Dundee
Kevin Morris - Collaborator - Boehringer-Ingelheim - UK
Scott Dickinson - Collaborator - Boehringer-Ingelheim - UK
Smit Patel - Collaborator - Boehringer-Ingelheim International GmbHOutcomes:
Primary Outcomes:
- Characteristics of patients at index date of withdrawal
- Number of patients withdrawing by calendar year and region
- Time without ICS (measured in months) following withdrawal.
This is defined as the time between index (Figure 3) to:
 date of subsequent ICS prescription (in any combination)
 or one of:
 loss of follow up, end of study period, death
- Number of exacerbations during withdrawal period: mild/moderate and severe (hospitalised) exacerbationsSecondary Outcomes
- Cough-related consultations
- Sputum-related consultations
- SABA/SAMA prescriptionsExploratory Outcomes
- Change in MRC score
- Pneumonia episodes
- Pneumonia hospitalisations
- Death (all-cause)Description: Technical Summary
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is an international organization that releases recommendations for COPD prevention, diagnosis and management. The recommendations for use of inhaled corticosteroids (ICS) state that ICS should be reserved for COPD patients with severe/very severe disease (GOLD C/D with frequent or severe exacerbations). Furthermore biomarkers and other patient phenotypes have been explored to best identify patients that would benefit most from ICS therapy. As many mild COPD patients have been identified as inappropriately prescribed ICS, withdrawal of ICS has been proposed. There is limited evidence around how to withdraw patients and which patients will succeed outside of a clinical trial setting. This study is a non-interventional cohort study using existing data (CPRD), to gain detailed insights on the withdrawal of maintenance ICS. The main objective of this study is to describe the trends in ICS withdrawal and identify characteristics associated with ICS-free time. The number of patients withdrawing over time will be described and a cox regression model will be used to determine the factors associated with ICS-free time and Kaplan Meier curves will be drawn to estimate 12-month withdrawal success (defined as time without ICS). The results from this study will be used to support the scientific understanding of current practice, to understand which patients are having this therapy withdrawn and whether they may be predictive characteristics to aid understanding of where this may be successful.
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The progression of key clinical parameters in adult diabetes patients (selected type 1 and type 2 diabetes sub-population): a retrospective cohort analysis to support economic modelling activities in a UK-specific context — Liz Zhou ...
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The progression of key clinical parameters in adult diabetes patients (selected type 1 and type 2 diabetes sub-population): a retrospective cohort analysis to support economic modelling activities in a UK-specific context
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Liz Zhou - Chief Investigator - SANOFI
Liz Zhou - Corresponding Applicant - SANOFI
Rikisha Gupta Shah - Collaborator - Evidera, IncOutcomes:
Clinical parameters: HbA1c; BMI; weight; SBP; eGFR
Description: Technical Summary
Objectives: The aim of this study is to use data from the Clinical Practice Research Datalink (CPRD) to evaluate the progression of key clinical parameters for uncontrolled adult T1DM patients over five years of follow-up.
Methods: Retrospective adult T1DM cohorts will be derived. The cohorts will be patients aged 18 and older with T1DM diagnosis and no T2DM diagnosis registered anytime and at least one insulin prescription between January 1, 2011 and December 31, 2011 (identification period) after T1DM diagnosis. Index date will be defined as the first insulin prescription during identification period. Baseline period will be defined by 12-month pre-index date and follow-up period by 60 months after index date. Continuous enrolment over baseline and follow-up will be required to be eligible for inclusion. Patients with most recent HbA1c measure in baseline less than or equal to 6.5% are excluded from the study. Four subpopulations of T1DM cohort are evaluated to assess how treatment impacts the progression of clinical parameters: those treated with continuous subcutaneous Insulin Infusion (CSII), multiple daily insulin injection (MDI), insulin plus metformin, and insulin plus SGLT2. A subpopulation of T2DM patients treated with basal bolus plus SGLT2 (those mimicking T1DM patient treatment regimen) are also studied. Included patients are age 18 and older, with T2DM diagnosis and no T1DM diagnosis, at least one antihyperglycemic prescription during identification period, continuous enrolment baseline and follow-up, no gestational diabetes, under basal bolus treatment, having SGLT2 use and valid HbA1c in baseline.
Analysis: Descriptive analysis will be conducted. Clinical parameters (HbA1c, BMI, weight, SBP, and eGFR) will be described at baseline and yearly in the 5 year follow-up. All these parameters will be described in overall T1DM population and in the five T1DM/T2DM sub-populations. For the T2DM sub-population, their non-insulin treatment use in baseline will also be described.
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Understanding the predictive values of symptoms, prescriptions, and investigation patterns for cancer and non-neoplastic disease in primary care consultees — Georgios Lyratzopoulos ...
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Understanding the predictive values of symptoms, prescriptions, and investigation patterns for cancer and non-neoplastic disease in primary care consultees
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Georgios Lyratzopoulos - Chief Investigator - University College London ( UCL )
Annie Herbert - Corresponding Applicant - University of Bristol
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Bethany Wickramsinghe - Collaborator - University College London ( UCL )
Cristina Renzi - Collaborator - University College London ( UCL )
Edmund Njeru Njagi - Collaborator - University College London ( UCL )
Emma Whitfield - Collaborator - University College London ( UCL )
Gary Abel - Collaborator - University of Exeter
Irene Petersen - Collaborator - University College London ( UCL )
Jessica Kurland - Collaborator - University College London ( UCL )
Kathy Pritchard-Jones - Collaborator - University College London ( UCL )
Matthew Barclay - Collaborator - University College London ( UCL )
Meenakshi (Meena) Rafiq - Collaborator - UCL Hospital
Monica Koo - Collaborator - University College London ( UCL )
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Nadine Zakkak - Collaborator - University College London ( UCL )
Rebecca White - Collaborator - University College London ( UCL )
Ruth Swann - Collaborator - University College London ( UCL )
Sara Benitez Majano - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah Price - Collaborator - University of Exeter
Tra Pham - Collaborator - University College London ( UCL )
William Hamilton - Collaborator - University of ExeterOutcomes:
The outcomes will be: diagnosis of cancer; diagnosis of serious non-neoplastic disease.
Description: Technical Summary
The overall research objective is to produce population-based evidence about the likelihood of cancer and serious non-neoplastic diseases* among primary care consultees, taking into account their symptoms and, where applicable, their history of repeat consultations, prescriptions, and investigations. We will estimate the predictive values of:
- Different symptomatic presentations for cancer (overall and by major tumour site) and serious non-neoplastic diseases diagnosed within a year after presentation.
- Symptoms combined with information on pre-diagnostic events (such as use of investigations or prescriptions).This evidence is needed to support clinical decisions about either specialist referral/investigation, or active monitoring (also known as 'safety netting') for patients 'at low but not no-risk'.
We will perform a cohort study, including patients aged 30 years or older with one or more pre-specified symptoms of interest recorded in CPRD between 2007 and 2016. Using primary and secondary care data linked to cancer registration data we will estimate the predictive values (and 95% confidence intervals) of each selected symptom, both for cancer and non-neoplastic disease. Positive predictive values will correspond to the proportion of patients with a given symptom that are diagnosed with a specific outcome (one of the cancers or non-neoplastic diseases of interest) within 1 year since first symptomatic presentation. Similarly, predictive values of different symptom-prescription-investigation combinations will be estimated. We will also examine the role of covariates (socio-demographic factors, comorbidities) possibly influencing predictive values.
*Hereafter we define serious non-neoplastic disease as disease that requires treatment and/or is progressive. An example is inflammatory bowel disease.
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Identifying risk factors associated with having a stroke following an acute exacerbation of COPD (AECOPD) — Jennifer Quint ...
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Identifying risk factors associated with having a stroke following an acute exacerbation of COPD (AECOPD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - Imperial College London
Chloe Bloom - Collaborator - Imperial College LondonOutcomes:
Primary outcome: stroke (fatal and non-fatal).
Description: Technical Summary
We will use CPRD¬-HES-ONS linked data to identify risk factors that that are associated with an increased risk of an acute stroke in the 90-day period immediately following a severe AECOPD. We will use a previously validated algorithm to define a cohort of study-eligible subjects, namely individuals in CPRD with COPD who have experienced at least one severe acute exacerbation of COPD (i.e. have been hospitalised for AECOPD). We will use a combination of a priori knowledge and literature searches to identify a list of potential risk factors. We will then conduct a series of univariable and multivariable logistic regression analyses to assess which of these factors are associated with an increased odds of experiencing a stroke in the period immediately following the onset of an AECOPD.
Source - and 15 more projects — click to show
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An external validation of the SAFEHEART vascular event risk prediction model in a UK routine care cohort with familial hypercholesterolaemia — Kausik Ray ...
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An external validation of the SAFEHEART vascular event risk prediction model in a UK routine care cohort with familial hypercholesterolaemia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
Kausik Ray - Chief Investigator - Imperial College London
Ailsa McKay - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Laura Gunn - Collaborator - Imperial College LondonOutcomes:
 Myocardial infarction
 Coronary revascularisation
 Ischaemic stroke
 Carotid revascularisation
 Peripheral vascular disease
 Peripheral arterial revascularisation
 Cardiovascular deathDescription: Technical Summary
Aim: an external validation of the SAFEHEART prognostic tool in predicting the 10-year risk of atherosclerotic cardiovascular disease (ASCVD) events
Study design: historical open cohort study
Observational period: 2000-2017
Population: a routine UK primary care cohort of individuals with familial hypercholesterolaemia, >18 years and < 80 years at baseline
Outcome: first occurrence, post cohort entry, of myocardial infarction, coronary revascularisation, ischaemic stroke, carotid revascularisation, peripheral vascular disease, peripheral arterial revascularisation, or cardiovascular death
Predictors: age, sex, ASCVD history, hypertension, body mass index, current smoking, low density lipoprotein-cholesterol and lipoprotein(a) levels
Performance assessment: We will describe the risk factor distributions and outcome incidence for the validation cohort, and calculate the 10-year estimated ASCVD event risk for each individual using the SAFEHEART tool. We will assess model accuracy using standard measures of calibration and discrimination for censored data, including those reported for the derivation dataset, to enable comparison. We will assess the clinical utility of the tool across a range of vascular risk estimates/potential treatment decision thresholds, in a decision curve analysis.
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The Health Economic Burden of Atopic Dermatitis and Associated Dermatologic Conditions: A Study of Cow's Milk Allergy (CMA) in patients > 5 years of age in the Primary and Secondary Care Pathways — Hassan Chaudhury ...
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The Health Economic Burden of Atopic Dermatitis and Associated Dermatologic Conditions: A Study of Cow's Milk Allergy (CMA) in patients > 5 years of age in the Primary and Secondary Care Pathways
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Hassan Chaudhury - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQOutcomes:
Incidence of atopic dermatitis (AD) in both primary and secondary care settings, and in each setting and geographic area in the database
- Inpatient admissions for AD (volume, cost, elective vs non-elective, seasonality, admission method, and discharge destination)
- Average inpatient length of stay
- 30-day readmission rate following an admission for AD
- Inpatient healthcare costs as stipulated in associated HRG-4+ codes of the dominant episode
- Outpatient appointments related to AD (volume, face-to-face vs tele consults, attended vs not attended, costs)
- Outpatient appointments related to AD in the Dermatology or Paediatric specialties/clinics
- Outpatient appointment cost and activity, including procedures performed
- Outpatient procedures performed on patients consulting with AD
- Outpatient prescriptions related to AD (total, number of products prescribed, and cost if available)Description: Technical Summary
The primary objective of this study is to describe the pathway of AD/CMA patients in terms of interaction with and burden upon the healthcare system. This burden will be measured by interactions with both Primary and Secondary care.
Patients with an age of 5 years and over from a HES-linked practice with any recorded read code diagnosis of AD AND any product used to treat CMA from the list included. The study period will be from 5 years, from April 2012 to March 2017. The index date for inclusion of a patient shall be the first diagnosis of AD and prescription of a CMA product within the study period. Outcomes would be tracked for all available time within the study period after the index date and annualised for comparison.
With the outcomes measured, the pathway of AD/CMA patients may be described, with stipulations as to the burden of care for both primary and secondary care.
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Clinical features of giant cell arteritis (GCA): An observational study using linked electronic primary and secondary care medical records — James Prior ...
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Clinical features of giant cell arteritis (GCA): An observational study using linked electronic primary and secondary care medical records
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-21
Organisations:
James Prior - Chief Investigator - Keele University
Lauren Barnett - Corresponding Applicant - Keele University
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Christian Mallen - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Toby Helliwell - Collaborator - Keele UniversityOutcomes:
GCA diagnosis,
Clinical features prior to a GCA diagnosisDescription: Technical Summary
Giant cell arteritis (GCA) is the most common form of large/medium vessel vasculitis, typically affecting people over the age of 50 years. If untreated, it can lead to permanent visual loss. Diagnosing GCA is often difficult due to a wide range of non-specific presenting symptoms which can lead to delays in diagnosis and appropriate treatment. The overall aim of this study is to estimate the occurrence of GCA, and to identify the most common groups of clinical features presented prior to diagnosis.
Our first objective is to estimate the burden of GCA in the UK population. The annual incidence and prevalence of GCA will be assessed between 1990 and 2017. Trends over time will be modelled using joinpoint regression. Our second objective is to examine the clinical features that patients present with in primary care prior to GCA diagnosis. We will perform a matched case-control study that will identify commonly reported clinical features (symptoms & comorbidities) prior to a GCA diagnosis. Using latent class analysis we will determine common patterns of clinical features presented to primary care prior to GCA diagnosis.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 3 -Replication of "Non-persistence and non-adherence of patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis" — Dorothee Bartels ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 3 -Replication of "Non-persistence and non-adherence of patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
Dorothee Bartels - Chief Investigator - Boehringer-Ingelheim Germany
Shirley Wang - Corresponding Applicant - Harvard University
Andrea Meyers - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Non-persistence to GLP-1 receptor agonist treatment compared between a twice-a-day (BID) treatment and an once-a-day (OD) treatment after 12 months (hazard ratio)
Description: Technical Summary
This objective of this protocol is to replicate the study: "Non-persistence and Non-adherence of Patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis" by Wilke et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Wilke paper compares the probability of discontinuing when prescribed twice-a-day (BID) treatment with GLP-1 receptor agonists versus once-a-day (OD) treatment in theUK general population between 2010 and 2012. We will focus on replicating the hazard ratio from a Cox-proportional hazard model for non-persistence between once-a-day and twice-a-day GLP-1 receptor agonist users over this time period. The reference group was considered the once-a-day users. Patients were followed for a year after their first prescription or until a treatment gap greater than 90 days at which point they were considered non-persistant. Descriptive statistics were calculated for GLP-1 receptor agonist users.
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Blood eosinophil levels as independent risk factor of severe asthma exacerbations and mortality in adult patients with asthma — Melissa Van Dyke ...
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Blood eosinophil levels as independent risk factor of severe asthma exacerbations and mortality in adult patients with asthma
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-05
Organisations:
Melissa Van Dyke - Chief Investigator - GSK
Melissa Van Dyke - Corresponding Applicant - GSK
David Webb - Collaborator - GlaxoSmithKline - UK
Esme Baan - Collaborator - Erasmus University Medical Center ( EMC )
Guy Brusselle - Collaborator - Ghent University Hospital
Katia Verhamme - Collaborator - Erasmus University Medical Center ( EMC )
Maria de Ridder - Collaborator - Erasmus University Rotterdam
Namhee Kwon - Collaborator - GSKOutcomes:
Severe asthma exacerbations and mortality
Description: Technical Summary
Asthma-related exacerbations remain a significant burden on the healthcare system and can be described as an acute episode of progressively worsening shortness of breath, wheezing, and chest tightness that results in decreased lung function. A severe asthma exacerbation can be defined as: (1) treatment with an initial or increased dose of oral corticosteroids (OCS), (2) an accident and emergency department (A&E) visit, and/or (3) a hospital admission. Eosinophilic asthma, recognisable due to its increased levels of blood eosinophils, has been associated with an increased risk of exacerbations, but few studies have also examined risk of mortality. Factors that may confound associations are inhaled corticosteroid use and age of asthma onset. This retrospective cohort study will identify asthma and severe asthma populations in general practitioners (GP) databases from 4 countries  UK, the Netherlands, Denmark and Spain  to examine the relationship between eosinophil levels and the risk of asthma exacerbations and death. Incidence rates of asthma exacerbations in strata based on level of blood eosinophils will be estimated. To analyse the effects on risk of severe asthma exacerbations, incidence rate ratios (IRRs) for intermediate and high levels of blood eosinophils compared to low levels will be estimated using crude and adjusted Poisson regression models. To analyse the effects on mortality, Kaplan-Meier curves will be provided showing survival in the three strata based on eosinophil level. Hazard ratios (HRs) for patients with intermediate and high levels of blood eosinophils compared to low levels will be estimated, both crude and adjusted for confounders. This study will also look at the stability of blood eosinophil levels change over time and potential effect modifiers. To describe the stability of the blood eosinophil measurements, generalized linear mixed models will be fitted on log-transformed data to estimate the between and within-patient variance and calculate the intra-class correlation coefficient.
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Translation of the electronic Frailty Index for use with the International Statistical Classification of Diseases and Related Health Problems tool in hip and knee replacement patients — Daniel Prieto...
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Translation of the electronic Frailty Index for use with the International Statistical Classification of Diseases and Related Health Problems tool in hip and knee replacement patients
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-14
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Rob Middleton - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Edward Burn - Collaborator - Oxford University Hospitals
Rory Ferguson - Collaborator - University of OxfordOutcomes:
1. Coefficients of agreement between READ and ICD-10 calculated eFI
2. Concordance of frailty levels determined by the ICD-10 based eFI and Hospital Frailty Risk ScoreDescription: Technical Summary
Hip and knee replacement are common operations in the NHS, with 200,000 in 2017. 90% of patients have an American Society of Anaesthesiologists (ASA) score of >/=2, indicating most patients have a degree of co-morbidity. Previous research has considered the influence of co-morbidity on outcome after joint replacement using standard measures such as the ASA score and Charlson Comorbidity Index, with increasing disease burdens associated with poorer outcomes. However, there is increasing recognition of the need to consider patient health in a more holistic manner. The concept of frailty has been developed to do this, which considers a patient's physiological, psychological and social care needs.
The electronic Frailty Index (eFI) was developed and validated by Clegg et al., and uses a cumulative deficit model applied to READ code based primary care records to calculate patient frailty. The eFI is now widely integrated in primary care data systems. However, as the eFI depends upon READ codes, it is not currently possible to calculate frailty with this tool using Hospital Episodes Statistics (HES) secondary care data, where information is coded according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10).
This study will map the eFI for use with ICD-10 codes, such that it can be used in future investigation of frailty in the setting of arthroplasty using hospital data. This will require cross-mapping of READ codes used in the eFI to corresponding ICD-10 codes. The eFI will then be applied to linked Clinical Practice Research Datalink (CPRD)/HES records to determine the coefficients of agreement for frailty determined by the two forms of eFI and the distribution of frailty in each dataset. Furthermore, we will compare the distribution of frailty between the ICD-10 mapped eFI, and the recently published ICD-10 based Hospital Frailty Risk Score.
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Testing a data-based definition of severity in atopic dermatitis in a linked primary and secondary care dataset in England: Implications on clinical outcomes and healthcare resource use — Adrian Paul J. Rabe ...
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Testing a data-based definition of severity in atopic dermatitis in a linked primary and secondary care dataset in England: Implications on clinical outcomes and healthcare resource use
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Hassan Chaudhury - Collaborator - Health iQOutcomes:
Prevalence (prevalence of AD, prevalence of mild AD, prevalence of moderate to severe AD, prevalence of co-morbidities including asthma, allergic conjunctivitis, allergic rhinitis, allergic urticaria, anxiety, cutaneous bacterial infection, depression, eosinophilic oesophagitis, food allergies), demographics (total patients, age, percent males, family history of atopy, time in cohort, follow-up), clinical outcomes (remission rate, absolute refractory rate, relapse rate, skin infection rate), healthcare resource use outcomes (inpatient admissions, inpatient length of stay, 30-day readmission rate, inpatient HRG tariffs, outpatient appointments, outpatient HRG tariffs, A&E attendances, GP appointments, nursing appointments in primary care, diagnostic tests in primary care, referrals in primary care, medications in primary care, consultation costs in primary care, prescription costs in primary care)
Description: Technical Summary
Atopic dermatitis is a highly prevalent condition in the United Kingdom. Datasets have become very useful in assessing the impact of various diseases, including AD, on the National Health Service. This effort is particularly important in the face of tightening budgets for healthcare in the country.
The definition of conditions in various datasets is an important task to improve the reliability and accuracy of estimates of healthcare resource use and clinical outcomes. A poor definition would result in an unreliable picture on which to base health policy and intervention in the health system.
This study aims to determine whether severity of AD as defined through codes in datasets have the increased cost and clinical outcome implications that are expected with clinical definitions. We plan to use a definition combining the use of immunosuppressants, systemic corticosteroids, HRG tariffs with a certain complication score, and atopic dermatitis as a primary inpatient admission diagnosis as criteria defining a cohort of patients with moderate to severe AD. All other AD shall be classified as mild.
We shall then measure prevalence, patient demographics and clinical profiles, co-morbidities, clinical outcomes, healthcare resource use and costs for each of these cohorts. The goal is to determine if there is a significant difference in these outcomes between the mild AD, and moderate to severe AD. A significantly higher healthcare resource use, and worse clinical outcomes would indicate that the data-based definition is functionally viable and may be used for further research endeavours on these datasets.
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Defining different recovery trajectories following acute infections as a measure of frailty — Colin Crooks ...
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Defining different recovery trajectories following acute infections as a measure of frailty
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-21
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Colin Crooks - Corresponding Applicant - University of Nottingham
John Gladman - Collaborator - Nottingham University Hospitals
Trevor Hill - Collaborator - University of NottinghamOutcomes:
Admission and length of hospital stay
- Clinical consultation rates
- All cause mortality
- Prescription rates
- Discharge or admission to care home
- Increased mobility needsDescription: Technical Summary
This proposal will reframe the concept of frailty by assessing the different patient recovery trajectories following a urine or respiratory community acquired infection 2005-2015. This will develop a framework for future frailty research that has true construct validity. Open population based cohorts will be used within routine healthcare data to map the different recovery trajectories across different dimensions. These will include consultation rates, prescription rates, diagnosis rates, specific diagnostic codes, sequences of codes, location of health care interactions (inpatient, community, care home), and mortality. Changes in each dimension from baseline will be assessed over time using within patient case series analysis. To efficiently and systematically identify the most common ordered sequences of events from many potential combinations sequential pattern mining will be used. These different recovery trajectories will then be stratified by pre-existing co-morbidity and frailty measures, and the characteristics of patients in each trajectory will be described. A Cox proportional hazards model will be used to adjust for the competing risks between the multiple different trajectories using cumulative incidence functions. This model will then be used to calculate the association of pre-existing the co-morbidity and frailty measures with each recovery trajectory.
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The pattern of incident fractures in patients with diabetes mellitus compared to matched controls — Patrick Souverein ...
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The pattern of incident fractures in patients with diabetes mellitus compared to matched controls
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-21
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Cindy Sarodnik - Collaborator - Maastricht University
Frank de Vries - Collaborator - Utrecht University
Johanna Driessen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Nicklas Rasmussen - Collaborator - Aalborg University Hospital
Nicolaas Schaper - Collaborator - Maastricht University
Peter Vestergaard - Collaborator - Aalborg University Hospital
Sandrine Bours - Collaborator - Maastricht UniversityOutcomes:
The incidence of various fracture types in diabetes compared to healthy controls in men and women, wherein diabetes will be divided in type I and type II.
- The incidence of various fracture types in diabetic patients with complications versus diabetic patients without complicationsDescription: Technical Summary
The pattern of incident fractures among patients with and without T1DM and T2DM. Within CPRD all patients with a first ever prescription for an insulin or a non-insulin anti-diabetic drug will be selected. Patients will be matched by year of birth, sex and practice to 1 control. Patients with a first ever prescription to an insulin need to have a diagnosis for T1DM before the index date (the date of the first prescription) to be included in our T1DM cohort. Patients with a first ever prescription to a non-insulin anti-diabetic drug need to have a diagnosis of T2DM before the index date to be included in our T2DM cohort. Patients in both cohorts will be followed for incident fractures.
Incidence rates will be calculated by dividing the number of fractures over the number of total person years. Incidence rate ratios will be calculated by dividing the incidence rates for patients with diabetes over the incidence rates of the controls. Fracture and sex specific incidence rates will be calculated. For patients with diabetes incidence rates will be stratified by the presence of diabetes complications at baseline.
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Fibrosing lung diseases: determinants, prognosis, and disease prediction — Harry Hemingway ...
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Fibrosing lung diseases: determinants, prognosis, and disease prediction
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-05
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Burcu Ozaltin - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Athol Wells - Collaborator - Royal Brompton Hospital
Joanna Porter - Collaborator - University College London ( UCL )
Joseph Jacob - Collaborator - University College London ( UCL )
Kenan Direk - Collaborator - University College London ( UCL )
Mark Jones - Collaborator - University of Southampton
Muhammad Qummer ul Arfeen - Collaborator - University College London ( UCL )
Nat Na-Ek - Collaborator - Farr Institute of Health Informatics Research
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Newly diagnosed fibrosing lung disease (FLD)- Newly diagnosed idiopathic pulmonary fibrosis (IPF)
- Newly diagnosed lung cancer
- Hospitalisation from any causes
- Respiratory mortality
- All-cause mortalityDescription: Technical Summary
Fibrosing lung diseases (FLD) is a group of chronic, progressive, fibrotic lung diseases with unknown aetiology associated with a shortened survival rate, and its incidence has been increasing every year. It is often misdiagnosed and managed inappropriately resulting in poor outcomes. This study aims to utilise linkage data from GPs, hospitals, and death registry to develop an algorithm to identify patients with FLD, with particular emphasis on Idiopathic Pulmonary Fibrosis (IPF), based on their diagnostic codes, symptoms, characteristics, and prescribed medications. Patients aged 40 years and older who did not have a history of FLD will be initially included and followed-up until they were censored (i.e., transfer out of their GP, being diagnosed, deaths, or end of study period). Then FLD cases will be monitored for disease progression (i.e., hospitalisation, development of lung cancer, or death), which leads to further investigation on the associations between disease and various risk factors, patterns of disease progression, medication options that might potentially be linked with disease risk, and models to predict FLD onset and prognosis. Findings from this study can improve understanding of the natural history of FLD, improve quality of care and management, and provide insight into preventive strategies.
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A personalized dynamic blood pressure control plan for patients with hypertension to maximize the delay of cardiovascular events — Samy Suissa ...
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A personalized dynamic blood pressure control plan for patients with hypertension to maximize the delay of cardiovascular events
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-19
Organisations:
Samy Suissa - Chief Investigator - McGill University
Robert Platt - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Qi Zhang - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Shahrzad Salmasi - Collaborator - McGill University
Tianze Jiao - Collaborator - University of FloridaOutcomes:
Major cardiovascular event (nonfatal myocardial infarction (MI), nonfatal stroke, or cardiovascular disease caused death)
- Expanded macrovascular event (nonfatal MI, nonfatal stroke, cardiovascular disease caused death, revascularization or hospitalization for congestive heart failure)
- Major coronary disease events (fatal coronary event, nonfatal MI, hospitalization for angina)
- MI (fatal and nonfatal)
- Total stroke (fatal and nonfatal)
- Death from any cause
- Cardiovascular disease (CVD) mortality
- Hospitalization or death due to congestive heart failure
- Severe adverse event related to antihypertensive treatment (such as hypotension, syncope, electrolyte abnormalities, bradycardia, and acute kidney injury or failure, which caused ER visits, hospitalizations, or reported in the routine visit)
- Lab values (systolic blood pressure [SBP], diastolic blood pressure [DBP], haemoglobin A1c [HbA1c], creatinine level)
- Anti-hypertensive medicationsDescription: Technical Summary
The level of BP is used to classify the severity of hypertension and to determine treatment goals (i.e., target BP level), both of which have changed over time. Treatment guidelines were recently revised to incorporate the results from two large randomized controlled trials (RCTs), ACCORD2 and SPRINT3. However, those studies failed to investigate the beneficial target BP level for patients at low cardiovascular (CVD) risk. Therefore, it is urgent to investigate the benefits of tight BP control among patients at low CVD risk and generate a personalized dynamic BP control plan for such patients. We will conduct a retrospective, population-based cohort study. We will identify all hypertensive patients with no previous history of CVD events who initiated an antihypertensive prescription from 1998-2018. Treatment patterns will be generated from class level (i.e., thiazide diuretics, angiotensin-converting-enzyme inhibitors). We will assign each patient to follow different BP control plans. The time to event hazard (i.e., major cardiovascular event, major coronary disease event, death from any cause) will be compared among different plans. Dynamic marginal structural modelling45 and inverse-intensity-rate-ratio weight will be applied to solve time-dependent confounders and covariate-dependent follow-ups, respectively.
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All-cause and cardio-renal-metabolic mortality in people with or without type 2 diabetes: a comparative international trend study — Kamlesh Khunti ...
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All-cause and cardio-renal-metabolic mortality in people with or without type 2 diabetes: a comparative international trend study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Freya Tyrer - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Suping Ling - Collaborator - University of LeicesterOutcomes:
All-cause and cardio-renal-metabolic deaths defined by ONS death records (codes in the Appendix)
Description: Technical Summary
Using data collected from the Clinical Practice Research Datalink (CPRD) Gold database with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS), we will investigate changes in all-cause and cardio-renal-metabolic mortality rate of patients with type 2 diabetes in the period 1998 - 2017 and compare these to patients without diabetes. The cohort will include incident subjects with diabetes identified within CPRD (exposed individuals) along with 5:1 matched participants without diabetes (non-exposed individuals). The outcomes are all-cause and cardio-renal-metabolic deaths, identified via linkage to ONS. All-cause and cause-specific (cardio-renal-metabolic) mortality rates will be estimated by age, sex, and calendar time in subjects with and without diabetes; then, rate ratio and rate differences between people without and without diabetes will be quantified separately for each country.
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Patient characteristic and treatment pattern for uncontrolled adult type 1 diabetes patients: a cross-sectional analysis to support economic modelling activities in a UK-specific context — Liz Zhou ...
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Patient characteristic and treatment pattern for uncontrolled adult type 1 diabetes patients: a cross-sectional analysis to support economic modelling activities in a UK-specific context
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-14
Organisations:
Liz Zhou - Chief Investigator - SANOFI
Liz Zhou - Corresponding Applicant - SANOFI
Rikisha Gupta Shah - Collaborator - Evidera, IncOutcomes:
Patient characteristics: age, gender, race, smoking status, alcohol use, duration of diabetes, HbA1c, BMI, weight, SBP, total cholesterol, LDL, HDL, triglyceride, eGFR, and comorbidities (see below)
? Myocardial Infarction (MI), Angina (stable and unstable), Peripheral Vascular Disease (PVD), Stroke, Congestive Heart Failure (CHF), Atrial Fibrillation (AF)
? End Stage Renal Disease (ESRD), Micro-albuminuria (MA), Gross Renal Proteinuria (GRP),
? Macular Edema (ME), Cataract
? Diabetic ulcer, Amputation
? Depression
? Diabetic Neuropathy, Neuropathy, Diabetic Nephropathy, Nephropathy, Diabetic Retinopathy, Background diabetic Retinopathy, Proliferative Diabetic Retinopathy
Treatment pattern:
? any, basal, bolus, premix insulin use (number and percent of patients)
? daily average consumption of total insulin, basal insulin and bolus insulin (DACON in IU/day and IU/kg/day) (mean[SD] and median [1st quartile, 3rd quartile])Description: Technical Summary
Objectives: The aim of this study is to use data from the Clinical Practice Research Datalink (CPRD) to describe patient characteristics and treatment pattern of uncontrolled adult type 1 diabetes patients in a cross-sectional study design.
Methods: Retrospective cross-sectional adult type 1 diabetes cohorts will be derived. The cohorts will be patients with type 1 diabetes diagnosis and no type 2 diabetes diagnoses registered anytime and at least one insulin prescription between January 1, 2016 and December 31, 2016 (identification period). Patients must be aged 18 and older on January 1, 2016. Continuous enrolment in 2016 will be required to be eligible for inclusion. Patients with average HbA1c in 2016 less than or equal to 6.5% are excluded from the study.
Analysis: Descriptive analysis will be conducted. Patient demographic (age, gender, race), behavioural (smoking, alcohol use) and clinical characteristics (duration of diabetes, HbA1c, BMI, weight, SBP, lipids, eGFR, and comorbidities) will be described. Type 1 diabetes patients treatment pattern (basal, bolus, premix insulin use, average daily dose) will also be reported overall and by Multiple Daily Insulin injection (MDI) and Continuous Subcutaneous Insulin infusion (CSII) groups.
Source -
The Costs and Complications of Colostomy, Ileostomy and Urostomy in England in Primary and Secondary Care: A 10-Year Study using Real World Datasets — Adrian Paul J. Rabe ...
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The Costs and Complications of Colostomy, Ileostomy and Urostomy in England in Primary and Secondary Care: A 10-Year Study using Real World Datasets
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-11
Organisations:
Adrian Paul J. Rabe - Chief Investigator - Health iQ
Adrian Paul J. Rabe - Corresponding Applicant - Health iQ
Hassan Chaudhury - Collaborator - Health iQOutcomes:
Patient Demographics (total patients, age, sex, ethnicity, time from stoma creation, Charlson Comorbidity Index, time in cohort, follow-up duration); Clinical Outcomes (all-cause mortality, inpatient mortality, skin complications, psychological and behavioural complications, parastomal hernia and stomal prolapse, urinary tract infections, sepsis, revision of stoma); Healthcare Resource Use Outcomes (inpatient admissions, procedures, specialties, and costs; outpatient admissions, procedures, specialties, and costs; accident & emergency attendances, procedures and costs; GP attendances, nursing interactions, prescriptions, medications, and referrals)
Description: Technical Summary
Colostomies, ileostomies and urostomies are interventions meant to alleviate the symptom and disease burden of conditions that affect the gastrointestinal and urinary tracts. By redirecting the flow of digestive products or urine cutaneously, the downstream tracts are allowed to undergo treatment, excision or recovery. However, the stomas formed in these interventions may have an increased tendency towards infection and skin disruption. Having a stoma itself may cause psychological and mental health issues. These complications, in turn, result in costs to the NHS in England, in both primary and secondary care.
This retrospective cohort study seeks to determine the incremental health system burden and costs of these 3 types of stomas in primary and secondary care in England, compared to an age- and sex- matched population of patients without stomas.
Three general cohorts shall be created using read codes in primary care to identify patients with a 1) colostomy, 2) ileostomy, and 3) urostomy. Their comparison control groups shall be created using age- and sex-matching in a 1:50 proportion.
Once the cohorts and their counterpart control groups are identified, their primary and secondary care records shall be retrieved. Data on patient demographics, clinical outcomes, and healthcare resource use outcomes shall be extracted. The primary outcome would be the total annual cost of inpatient, outpatient, A&E and GP care. Costs will be computed utilising BNF prices, HRG tariffs, and PSSRU prices multiplied by the volume of resources consumed. Comparisons between each cohort and their counterpart control group shall be made on the outcomes specified, using either odds ratios or mean differences where applicable, with 95% confidence intervals and p-values reported. Student's unpaired t-test shall be used for comparisons of the means of two groups. Fisher's test or the chi-square test shall be performed to compare proportions in two groups.
With these comparisons, the researchers hope to quantify the incremental costs and complication burden that colostomies, ileostomies and urostomies pose to the English NHS.
Source -
Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 20 - Replication of "Risk of Death and Cardiovascular Outcomes with Thiazolidinediones: A Study with the General Practice Research Database and Secondary Care Data" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 20 - Replication of "Risk of Death and Cardiovascular Outcomes with Thiazolidinediones: A Study with the General Practice Research Database and Secondary Care Data"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-12-05
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Shirley Wang - Corresponding Applicant - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Risk of cardiovascular events and mortality
Description: Technical Summary
This objective of this protocol is to replicate the study: "Risk of Death and Cardiovascular Outcomes with Thiazolidinediones: A Study with the General Practice Research Database and Secondary Care Data" by Gallagher et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Gallagher paper describes the risks of cardiovascular events and mortality in patients using diabetes medication in the United Kingdom (UK) between 1987 and 2007. We will focus on replicating risks of cardiovascular events and mortality in patients using diabetes medication over this time period. Patients will be followed up to the date of censoring (transfer out of the practice, last collection from the practice, or death).
Source
2018 - 11
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REPEAT Study 17 - Replication of "Risk of major bleeding and stroke associated with the use of vitamin K antagonists, nonvitamin K antagonist oral anticoagulants and aspirin in patients with atrial fibrillation: a cohort study" — Shirley Wang ...
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REPEAT Study 17 - Replication of "Risk of major bleeding and stroke associated with the use of vitamin K antagonists, nonvitamin K antagonist oral anticoagulants and aspirin in patients with atrial fibrillation: a cohort study"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-30
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Major bleeding defined as a bleeding at a critical site or organ (see appendix for READ codes).
Description: Technical Summary
This objective of this protocol is to replicate the study: "Risk of major bleeding and stroke associated with the use of vitamin K antagonists, nonvitamin K antagonist oral anticoagulants and aspirin in patients with atrial fibrillation: a cohort study" by Gieling et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Gieling paper compared the risk of major bleeding in patients with atrial fibrallation using nonvitamin K antagonist oral anticoagulants (NOACs) compared to patients with atrial fibrallation using vitamin K antagonists (VKAs) in the UK general population between 2008 and 2014. We will focus on replicating the age/sex adjusted hazard ratio comparing the risk of major bleeding in atrial fibrillation patients for current users of NOACs versus current users of VKAs over this time period. Patients will be followed until a first-ever diagnosis of major bleeding, death from any cause, or end of the study period (October 1, 2014), whichever occurred first. Comparative risk of major bleeding will be evaluated using a Cox proportional hazards model. Descriptive statistics will be calculated for users of NOACs and users of VKAs within the cohort.
Source -
An external validation of the SMART vascular event risk prediction model in a secondary prevention UK routine care cohort — Kausik Ray ...
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An external validation of the SMART vascular event risk prediction model in a secondary prevention UK routine care cohort
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-16
Organisations:
Kausik Ray - Chief Investigator - Imperial College London
Ailsa McKay - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Laura Gunn - Collaborator - Imperial College LondonOutcomes:
 Myocardial infarction
 Stroke (ischaemic or haemorrhagic)
 Cardiovascular deathDescription: Technical Summary
Aim: An external validation of the SMART prognostic tool in predicting the 10-year risk of secondary atherosclerotic cardiovascular disease (ASCVD) events.
Study design: Historical open cohort study
Observational period: 2000-2017
Population: A UK routine primary care cohort, >18 and <80 years at baseline, diagnosed with coronary, cerebrovascular, peripheral and/or aortic ASCVD
Outcome: First occurrence of myocardial infarction, stroke (ischaemic or haemorrhagic), or CVD death, post cohort-entry
Predictors: Age, sex, diabetes, smoking status; cholesterol, blood pressure, renal function and high sensitivity C-reactive protein (hSCRP) measurements; ASCVD history (years since clinical manifestation; vascular bed(s) affected). hsCRP values (not available in CPRD) will be imputed using age*sex*ASCVD diagnosis-specific mean values observed in the derivation cohort, and missing non-hsCRP predictor values using standard methods.
Performance assessment: We will describe the risk factor distributions and outcome incidence for the validation cohort, and calculate the 10-year estimated ASCVD event risk for each individual using the SMART tool. We will assess model accuracy using standard measures of calibration and discrimination for censored data, including those reported for the derivation dataset to enable comparison. We will assess the clinical utility of the tool across a range of vascular risk estimates/potential treatment decision thresholds, in a decision curve analysis.
Source -
Evaluation of probable treatment indications for the prescription of oral glycopyrronium in the United Kingdom - both licensed and off-label — Craig Currie ...
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Evaluation of probable treatment indications for the prescription of oral glycopyrronium in the United Kingdom - both licensed and off-label
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-05
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
- Collaborator -Outcomes:
Diagnoses at the time of prescribing glycopyrronium.
Description: Technical Summary
The aim of this retrospective, descriptive study is to characterise as far as possible the treatment indications for oral glycopyrronium within UK primary care using the CPRD GOLD dataset. The study will inform a regulatory submission to the MHRA by the study's funder, Kinedexe UK Ltd. Glycopyrronium is an anticholinergic drug that inhibits aspects of the parasympathetic nervous system. Until recently, its licensed indications in the UK were hyperhidrosis (excessive perspiration) and peptic ulcer, but in January 2017 a glycopyrronium product became licensed to treat sialorrhoea (excessive or uncontrolled salivation) in children and adolescents. It is widely accepted, however, that glycopyrronium has been prescribed off-label for this symptom for some years before this, although little is currently known about the extent of that historic prescribing. We wish to analyse data from CPRD GOLD in order to address this evidence gap. Children and adults having at least one prescription for oral glycopyrronium (1mg or 2mg tablet or solution/liquid formulations) from January 2008 to June 2018 will be selected and classified by their age at prescription and probable indication, the latter being based on associated clinical and referral records for the licensed indications for glycopyrronium (hyperhidrosis, peptic ulcer, sialorrhoea) and medical conditions associated with hypersalivation (cerebral palsy, Parkinson's disease, motor neurone disease), and on prescription records for drugs (antipsychotic drugs and cholinergic agonists) associated with the side-effect of hypersalivation. Patients with more than one indication or with no discernible indication will be classified as such. We will present patient numbers and the frequency and duration of prescribing by age group and probable indication. Findings will be summarised with wide granularity and all stratifications with fewer than five patients will be suppressed in accordance with CPRD guidelines to prevent the risk of deductive/unintentional disclosure.
Source -
Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT) Study 19: Replication of "Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study." — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT) Study 19: Replication of "Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study."
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-14
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Shirley Wang - Corresponding Applicant - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jeremy Rassen - Collaborator - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Fracture
Description: Technical Summary
This objective of this protocol is to replicate the study: "Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study." by Driessen et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Driessen paper describes the association between long term DPP-4 inhibitor use and the risk of fracture among people with type-2 diabetes in the general population of the United Kingdom (UK) between 2007 and 2015. We will focus on replicating the outcome of risk of fracture among people with type 2 diabetes over this time period. Patients will be followed until the end of the study period, date of transfer of the patient out of practice, death, or the first record of fracture recorded in the CPRD, whichever occurred ?rst. Comparative risk of fracture will be evaluated using a Cox proportional hazards model.
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The impact of knee replacement on mortality in the presence of chronic disease — Susan Jick ...
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The impact of knee replacement on mortality in the presence of chronic disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-26
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Jessica Maxwell - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
1. Primary outcome: Death
2. Secondary outcomes: Chronic comorbidities including cardiovascular disease, diabetes, hypertension, congestive heart failure, cognitive illness, depression, infectious diseases, kidney disease, mental illness, peripheral vascular disease, pulmonary disease, and gastrointestinal disease.Description: Technical Summary
Knee osteoarthritis (KOA) is a leading cause of disability1 and has been associated with morbidity and mortality2. Currently, knee replacements (KR) are the only known effective long-term intervention for end-stage knee osteoarthritis. Consequently, the prevalence of KRs is escalating worldwide3. Whether total KR can reverse the increased risk of mortality among people with KOA is currently unclear. While it is hypothesized that KR would have a favorable effect on mortality, likely through promoting increased mobility1 and thereby improved health, studying this question is methodologically challenging due to the difficulty in controlling for confounding by indication. Patients with KOA undergoing KR may be healthier than those who do not undergo a KR.
We plan to conduct a cohort study in a population of patients with knee osteoarthritis (KOA) to assess mortality rates in patients with and without a knee replacement (KR). From among all patients with KOA we will identify people with a first primary KR code on or after the date of cohort entry (date of first KOA). Each KR patient will be matched to a non-KR patient on year of birth and sex. Each patient will then be followed from their index date (date of KR or a randomly assigned index date for non-KR patients), to censor date (date of death or end of record whichever comes first). We will calculate incidence rates and hazard ratios for death in the two cohorts. We will also identify a second a propensity score matched cohort of non-KR patients to control for health status in KR compared to non-KR patients since the is a chance that patients who have a KR are healthier that those who do not.
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Living with Ulcerative Colitis Study in England: A non-interventional, retrospective study in England to evaluate healthcare resource utilization and the direct healthcare cost of post-operative care in patients with ulcerative colitis — Robert Wood ...
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Living with Ulcerative Colitis Study in England: A non-interventional, retrospective study in England to evaluate healthcare resource utilization and the direct healthcare cost of post-operative care in patients with ulcerative colitis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Robert Wood - Corresponding Applicant - Adelphi Real World
John Waller - Collaborator - Adelphi Real World
Joseph Cappelleri - Collaborator - Pfizer Inc - US Headquarters
Leonardo Salese - Collaborator - Pfizer Inc - US Headquarters
Marco DiBonaventura - Collaborator - Pfizer Inc - US Headquarters
Natalie Bohm - Collaborator - Pfizer Ltd - UK
Olivia Massey - Collaborator - Adelphi Real World
Ruth Mokgokong - Collaborator - Pfizer Ltd - UK
Stuart Blackburn - Collaborator - Adelphi Real WorldOutcomes:
All-cause GP appointments; All-cause hospitalisations; All-cause outpatient appoints; All-cause emergency admissions; Primary care prescriptions of steroids, immunosuppressants and aminosalicylates; Post-operative complications in secondary care; Associated direct healthcare costs
Description: Technical Summary
Objectives: The primary objective is to estimate the pre- and post-operative healthcare resource utilisation (HCRU) and direct healthcare costs among patients with ulcerative colitis (UC) undergoing a colectomy.
Methods: This study will be a retrospective, longitudinal cohort study of ulcerative colitis patients undergoing a colectomy between Jan 2011 and Dec 2015, inclusive. The cohort of patients will be identified from the Clinical Practice Research Datalink and Hospital Episode Statistics (Admitted Patient Care and Outpatient data sets). Then index event will be defined using Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures (4th revision) codes. Elements of HCRU that will be considered in this study include General Practitioner consultations, medicines prescribed in primary care (aminosalicylates, corticosteroids and immunosuppressants), outpatient appointments and inpatient stays (including additional surgeries, length of stay, high-cost drug use).
Data analysis: The study will be predominantly descriptive in nature, with elements of comparative analysis between patients undergoing an elective colectomy versus an emergent colectomy. In addition, generalised linear models will be constructed to assess potential predictors of high post-operative HCRU and/or costs, type of colectomy required and post-operative complications experienced.
Source -
Changes in COPD inhaler prescriptions in the UK, 2000 to 2016 — Jennifer Quint ...
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Changes in COPD inhaler prescriptions in the UK, 2000 to 2016
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
Prescription of COPD inhalers and characteristic of patients using different inhaled medication classes
Description: Technical Summary
We will identify all COPD patients in CPRD database between 2000 and 2016 using a validated algorithm. We will first total all prescriptions each year and by their medication class. We will then identify all prevalent prescriptions and all incident prescriptions year-on-year, from 2000 to 2016. We will also describe in the year 2016 the patients that are in each of the medication classed, including demographics and disease specific variables such as spirometry and dyspnoea score. The description will include COPD exacerbations therefore only CPRD linked data will be used for this part (to include both GP treated and hospital treated exacerbations).
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DPP-4 inhibitor dose selection according to Summaries of Product Characteristics: A contemporary experience from the UK General Practice — Dionysios Spanopoulos ...
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DPP-4 inhibitor dose selection according to Summaries of Product Characteristics: A contemporary experience from the UK General Practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-19
Organisations:
Dionysios Spanopoulos - Chief Investigator - Eli Lilly & Co - UK
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Brendan Barrett - Collaborator - Boehringer-Ingelheim - UK
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Michael Busse - Collaborator - Boehringer-Ingelheim - UKOutcomes:
1. Higher than SPC specified dose per renal function range:
 Alogliptin
o CrCl ( 50-30 ml/min): alogliptin 25 mg (n, %)
o CrCl (<30 ml/min): alogliptin 12.5 or 25 mg(n, %)
 Vildagliptin
o CrCl ( < 50 ml/min): vildagliptin 50 mg BID (n, %)
 Sitagliptin
o eGFR (< 45 Â 30 ml/min): sitagliptin 100 mg (n, %)
o eGFR (<30 ml/min): sitagliptin 100 or 50 mg (n, %)
 Saxagliptin
o eGFR (< 45 ml/min): saxagliptin 5 mg (n, %)2. Lower than SPC specified dose per renal function range:
 Alogliptin
o CrCl (> 50 ml/min): alogliptin 12.5 or 6.25 mg (n, %)
o CrCl (< 50-30 ml/min): alogliptin 6.25 mg (n, %)
 Vildagliptin
o CrCl (> 50 ml/min): vildagliptin 50 mg QD (n, %)
 Sitagliptin
o eGFR (> 45 ml/min): sitagliptin 50 or 25 mg (n, %)
o eGFR (< 45-30 ml/min): sitagliptin 25 mg (n, %)
 Saxagliptin
o eGFR (> 45 ml/min): saxagliptin 2.5 mg (n, %)Description: Technical Summary
DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin) are a drug class indicated for the glycaemic control in patients with Type II Diabetes Mellitus (T2DM). Summaries of Product Characteristics (SPC) require all DPP-4 inhibitors, except linagliptin, to be dose adjusted according to renal function. Linagliptin is the only member that can be prescribed irrespective of patient renal function. Previous UK study demonstrated that approximately one third of T2DM patients initiating alogliptin, saxagliptin, sitagliptin or vildagliptin with a Creatinine Clearance (CrCl) <50 mL/min, which was the common threshold of dose adjustment for all non-linagliptin DPP-4 inhibitors at the time of analysis, were on a higher dose than the SPC specified dose. In addition, another recent study demonstrated that at least 10% of T2DM patients with CrCl >50 mL/min initiating on a DPP-4 inhibitor were prescribed a lower than the SPC specified dose. In January and July 2018, SPCs of sitagliptin and saxagliptin were updated to include new requirements for dose adjustment, specifying an eGFR of 45 ml/min as new threshold for dose adjustment. Even though CrCl was the mainstay of measuring renal function in the past, currently, the recommended metric of renal function is glomerular filtration rate (GFR) in the UK clinical practice.
Adopting a retrospective cross-sectional study design and incorporating the new thresholds of dose adjustment for sitagliptin and saxagliptin, this study will generate descriptive statistics to to characterise DPP-4 inhibitor dose selection in relation to manufacturer specifications in a patient cohort treated with DPP-4 inhibitors after the implementation of renal threshold changesThe rationale of the study is to explore whether or not and the extent to which adoption of the recommended measure of kidney function into product specifications has resulted in an improvement in dose selection in routine clinical practice.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 18-Replication of "Risk of Myocardial infarction in Patients with Atrial Fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 18-Replication of "Risk of Myocardial infarction in Patients with Atrial Fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-19
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Jeremy Rassen - Corresponding Applicant - Aetion, Inc
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Occurrence of acute myocardial infarction
Description: Technical Summary
This objective of this protocol is to replicate the study: "Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspririn or direct acting oral anticoagulants" by Stolk et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Stolk paper compared the risk of AMI in patients with atrial fibrillation who initiated treatment with DOACs or to those who initiated VKAs in the UK general population between 2008 and 2014. We will focus on replicating the adjusted hazard ratio comparing the risk of AMI in atrial fibrillation patients for current users of DOACs versus current users of VKAs over this time period. Patients will be followed until the end of the study period (June 30, 2014), date of transfer of the patient out of practice, death, or the first record of AMI recorded in the CPRD, whichever occurred ?rst.Comparative risk of AMI will be evaluated using a Cox proportional hazards model. Descriptive statistics will be calculated for users of DOACs and users of VKAs within the cohort.
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The prevalence of co-prescribing of tramadol and antidepressants during 1998-2017, and associated risk of all-cause mortality and emergency hospital admissions — Caroline Copeland ...
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The prevalence of co-prescribing of tramadol and antidepressants during 1998-2017, and associated risk of all-cause mortality and emergency hospital admissions
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-21
Organisations:
Caroline Copeland - Chief Investigator - St George's, University of London
Iain Carey - Corresponding Applicant - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
 Mortality (Primary)
 Emergency Hospital Admissions (Secondary)
 A&E attendance (Secondary)Description: Technical Summary
Chronic pain and depression are common comorbidities, especially amongst older adults. Antidepressants and opioid analgesics, are therefore often co-prescribed in primary care. Tramadol relieves pain via mu-opioid receptor activation, and enhancement of serotonergic and noradrenergic transmission. Combining tramadol with other serotonergic enhancers, such as antidepressants, could therefore induce serotonin syndrome - a potentially fatal complication. However, it is not known how widespread co-prescribing is, nor what excess risk might be associated with co-prescribing. Data from the National Program on Substance Abuse Deaths reports 144 UK deaths in 2012-15 where tramadol-antidepressant co-consumption was directly implicated, equating to one death every ten days.
The proposed research aims to use the Clinical Practice Research Datalink (CPRD) to firstly ascertain the prevalence of tramadol-antidepressant co-prescribing in the UK over the last 20 years. Secondly, it will use linked hospital admissions and mortality data to determine to what extent tramadol-antidepressant co-prescriptions are associated with adverse outcomes such as emergency hospital admissions and death. We will carry out statistical analyses that compare prescribing periods when patients are prescribed both drugs with periods when only one drug is prescribed. To add robustness to the findings, we will use different statistical methods (time-to-event, self- controlled case series) as well as carrying out a comparison to the co-prescribing of antidepressants with codeine. This research has the potential to inform tramadol-antidepressant prescribing practice to prevent adverse outcomes and raise awareness amongst healthcare professionals and the public about dangers of tramadol-antidepressant combined use.
Source - and 21 more projects — click to show
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 16 - "Use of tamoxifen and aromatase inhibitors in a large population-based cohort of women with breast cancer" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 16 - "Use of tamoxifen and aromatase inhibitors in a large population-based cohort of women with breast cancer"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Jeremy Rassen - Corresponding Applicant - Aetion, Inc
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Percentage of tamoxifen or aromatase inhibitor users who discontinue treatment within 5 years.
Description: Technical Summary
This objective of this protocol is to replicate the study: "Use of tamoxifen and aromatase inhibitors in a large population-based cohort of women with breast cancer" by Huiart et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Huiart paper describes the percentage of women from 1998 to 2008 with breast cancer who discontinue treatment with tamoxifen and aromatase inhibitors within the first 5 years. We will focus on replicating the outcome of percentage of patients with breast cancer who discontinue treatments within 5 years over the same study period. All patients were followed from cohort entry (date of first prescription) to the end of treatment (up to 5 years), death from any cause, breast cancer recurrence or contralateral breast cancer, thrombo-embolic event, or endometrial cancer, whichever came first. Non-persistence to treatment was defined as the first treatment discontinuation longer than 3 months. Time to treatment discontinuation was calculated using Kaplan-Meier estimates.
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Impact of recurrent hospitalization events on mortality in patients with Heart Failure: a retrospective analysis of a UK database — Raquel Lahoz ...
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Impact of recurrent hospitalization events on mortality in patients with Heart Failure: a retrospective analysis of a UK database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Raquel Lahoz - Chief Investigator - NOVARTIS
Ailis Fagan - Corresponding Applicant - NOVARTIS
Ann Barber - Collaborator - Not from an Organisation
Clare Proudfoot - Collaborator - Novartis Pharma AG
Martin McSharry - Collaborator - Optum
Philippe Ferber - Collaborator - Novartis Pharma AG
Rachel Studer - Collaborator - Novartis Pharma AG
Sibasish Saha - Collaborator - Novartis Pharma AGOutcomes:
Primary:
Unadjusted and adjusted relative cardiovascular (CV) mortality rates for 1, 2, 3, ?4 HF hospitalizations after the index HF hospitalization compared to patients without recurrent heart failure hospitalizations (for all HF patients and HF phenotype subgroups);Endpoints for Secondary Objectives 1, 2 and 3:
Unadjusted and adjusted CV and all-cause relative mortality rates for 1, 2, 3, ?4 HF hospitalizations after the index HF hospitalization compared to patients without recurrent heart failure hospitalizations (for all heart failure patients, stratified by HF phenotype and specific comorbidities);
Unadjusted and adjusted CV and all-cause relative mortality rates for 1, 2, 3, ?4 HF hospitalizations after the index HF hospitalization compared to patients without recurrent heart failure hospitalizations for all HF patients controlling for HF phenotype;
Time to CV death from index hospitalization and from 1st, 2nd, 3rd and 4th recurrent hospitalization;
Time to all cause death from index hospitalization and from 1st, 2nd, 3rd and 4th recurrent hospitalization;
Time to 1st, 2nd, 3rd and 4th recurrent hospitalization from index hospitalization;
Time to immediate next recurrent hospitalization from the previous recurrent hospitalization (1st to 2nd, 2nd to 3rdand 3rd to 4th);Endpoint for Secondary Objective 4:
Unadjusted and adjusted relative in-hospital CV mortality rates for 1, 2, 3, ?4 HF hospitalization after the index HF hospitalization compared to patients without recurrent heart failure hospitalizations;
Time to in-hospital CV death from index hospitalization and from 1st, 2nd, 3rd and 4th hospitalization;
Proportion of patients discharged alive for the 1st, 2nd, 3rd, and ?4th HF hospitalizations;Endpoint for Secondary Objective 5:
Variables predictive of mortality and recurrent hospitalizations;
Baseline patient characteristics as available from the data source associated with all-cause and CV mortality and HF hospitalizations.Description: Technical Summary
Objectives:
Heart failure (HF) is a leading cause of hospitalization among older adults. It is associated with a large burden of disease for the individual and with high morbidity and mortality post diagnosis. Previous studies have suggested that recurrent hospitalizations is a strong predictor of mortality. The main objective of this study is to quantify the association between recurrent HF hospitalizations and cardiovascular (CV) death in the overall HF population and in patients with different ejection fraction (EF) phenotypes. The two types of EF phenotypes are HF with "reduced" EF (HFrEF) and HF with "preserved" EF (HFrEF). Other objectives are similar to the main objective and include: quantifying the association between recurrent HF hospitalizations and (i) all cause death and (ii) CV death in a hospital setting for the overall HF population and EF phenotype; quantifying the association between recurrent HF hospitalizations with all-cause or CV death in patients with comorbidities of interest; and trying to find predictors of mortality. We wish to leverage the Clinical Practice Research Datalink (CPRD) linked to national hospital episode statistics (HES) and mortality statistics (ONS) in order to quantify these associations for the UK population. The results from this study will help illustrate the potential benefits for a promising new Novartis HF drug in the UK population.Methods:
Descriptive statistics will characterise the demographic and clinical characteristics of the patients at their first hospitalization. Cox proportional hazards regression will quantify the relationship between recurrent hospitalizations and mortality. Time to event (hospitalization and death) will be displayed using Kaplan-Meier graphs with comparisons calculated by the log-rank test. Negative binomial regression will be used to establish potential predictors of mortality using baseline demographic and clinical characteristics.Study design:
This is a cohort study of patients aged >18. Patients with a HF diagnosis in the primary care database will be used to find patients in HES with HF in-patient admissions. Patients will be used for the analysis that are admitted for HF in the in-patient setting from 2010 to 2014 (inclusive) and without admissions for HF in the four years previous. Follow-up will be until study end, death or transfer out of practice.
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Clusters of Chronic Obstructive Pulmonary Disease (COPD) co-morbidities and their relevance to mortality, service use, age and socioeconomic status. — Steven Kiddle ...
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Clusters of Chronic Obstructive Pulmonary Disease (COPD) co-morbidities and their relevance to mortality, service use, age and socioeconomic status.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-30
Organisations:
Steven Kiddle - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Steven Kiddle - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Duncan Edwards - Collaborator - University of Cambridge
Hannah Whittaker - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Paul Kirk - Collaborator - University of Cambridge
Sylvia Richardson - Collaborator - University of Cambridge
Yajing Zhu - Collaborator - University of CambridgeOutcomes:
One-year and five-year mortality, treatment burden (number of current prescription medications) and number of hospitalisations.
Description: Technical Summary
We will extract co-morbidities from every Clinical Practice Research Datalink (CPRD) Chronic Obstructive Pulmonary Disease (COPD) patient with linked ONS-HES-IMD data, who are alive in 2012, to allow us to study five-year survival. We will study 36 co-morbidities 1 using definitions created by the Quint group or by the Cambridge CPRD team https://www.phpc.cam.ac.uk/pcu/cprd_cam/codelists/ .
We will extract five-year and one-year mortality using ONS data, treatment burden from CPRD and number of hospitalisations from HES. Profile regression will then be used to identify clusters relevant to mortality, hospitalisations, treatment burden, age and index of multiple deprivation, which will be summarised in heatmaps.
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An analysis of linked healthcare datasets to examine the relationship between secondary prevention and long-term outcomes in patients with aortic disease in England — Colin Bicknell ...
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An analysis of linked healthcare datasets to examine the relationship between secondary prevention and long-term outcomes in patients with aortic disease in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Colin Bicknell - Chief Investigator - Imperial College London
Colin Bicknell - Corresponding Applicant - Imperial College London
Alberto Vidal-Diez - Collaborator - Imperial College London
Guy Martin - Collaborator - Imperial College London
Janet Powell - Collaborator - Imperial College London
Joshua Symons - Collaborator - NHS Digital ( HSCIC )
Neil Poulter - Collaborator - Imperial College London
Viknesh Sounderajah - Collaborator - Imperial College LondonOutcomes:
Aortic/cardiovascular events
- Aortic/cardiovascular mortality
- All-cause mortality
- Hospital admissions (elective and emergency)
- Aortic/cardiovascular interventionsDescription: Technical Summary
Symptomatic aortic aneurysms and aortic dissections represent the two most commonly occurring aortic emergencies in England. They can result in significant morbidity and mortality, however, in the absence of acute aortic morphology changes or complications, a clinically stable phase may be achieved with judicious blood pressure control and statin therapy. In addition, there is emerging evidence for the potential protective effect of metformin and other medications
Current guidelines advocate the use of beta-blockers as first line anti-hypertensive therapy despite a paucity of evidence to support this. Moreover, there have been no large-scale population studies examining the relationship between blood pressure control and long-term outcomes. Statin therapy and metformin have also been positioned as having protective effects on the aorta, but once again there is a lack of longitudinal data for their impact.
This study aims to interrogate linked primary and secondary care data to examine the relationship between blood pressure control and medication choice, statin therapy and metformin with long-term health outcomes in patients with aortic disease. In order to answer these research questions previously employed cox-regression models will be used with g-computation formulas to adjust for confounding and study the effect of dynamic treatment options on patient outcomes.
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Burden of disease in patients with Chronic Obstructive Pulmonary Disease (COPD) — David Price ...
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Burden of disease in patients with Chronic Obstructive Pulmonary Disease (COPD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-28
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Marianna Alacqua - Collaborator - Astra Zeneca Inc - USA
Stephanie Chen - Collaborator - Astra Zeneca Inc - USAOutcomes:
Outcomes of HCRU will be measured in one year after ID (outcome year) for those from cohorts 1-3 who have
complete data and will also be described in the year prior to ID (baseline year) (objective 3) as mean numbers of:
1. COPD exacerbations (acute oral corticosteroids and/or respiratory-related antibiotics course and/or respiratory-related A&E attendance or inpatient hospitalisation)
2. Inpatient hospitalisation admissions (numbers, duration and readmissions within 30, 60 and 90 days) for:
a. COPD exacerbation (ICD10 J44.0, J44.1 or J44.9)
b. COPD (J40.0-J44.9)
c. Respiratory related disease (J%)
d. All-cause
3. Accident & Emergency (A&E) attendances for
a. COPD (DIAG2 = 25 or DIAG = 'COPD' or DIAG2 = 'J4')
b. All-cause
4. Outpatient visits,
a. Respiratory disease (Service code 340)
b. All-cause
The mortality rate will be described in all patients from cohorts 1-3 using linked ONS data:
a. COPD-related (J40.0-J44.9)
b. All-causeDescription: Technical Summary
Objective 1: To identify and characterise COPD patients that can be the target for biologic therapies, by allocating and characterising the following four study cohorts:
1. General population of patients with 'active' COPD, who had >/=1 prescription for maintenance inhaled therapy
2. Patients with 'active' GOLD grade C/D (high risk) on dual or triple therapy
3. Patients with 'active' GOLD grade C/D (high risk) on triple therapy
4. 'End-stage of COPD' cohort: patients with 'active' COPD who died before the last extraction from general practice and who had >/=1 prescription for maintenance therapy within the period of 12 months prior to deathObjective 2: To describe the characteristics of subgroups of patients with 'active' GOLD grade C/D on dual or triple therapy (cohorts 2 and 3), defined by the following characteristics and combinations of (some of) these characteristics:
1. Rate of COPD exacerbations
2. Occurrence of COPD-related hospitalisation
3. Average oral corticosteroids (OCS) exposure
4. Blood eosinophil count (BEC)
5. Smoking status
6. Presence of airway obstruction (FEV1/FVC <0.70)
7. Number of years with >/=1 or >/=2 exacerbations in the previous 10 years (subpopulation with complete data)Objective 3: To assess outcomes and health care resource utilisation (HCRU) during one-year of follow-up in cohorts 1-3
Objective 4: To assess the all-cause and COPD-related mortality during one-year of follow-up in cohorts 1-3 using linked data to the Office for National Statistics (ONS).
The index date will be a randomly selected date of a prescription for maintenance therapy for COPD within a time window of 24 to 12 months before the most recent date when data were extracted from the GP practice (to select all patients with active COPD with at least one-year of follow-up after ID)
The study will describe demographics, comorbidities and clinical characteristics of the four cohorts and the subpopulations in the baseline year prior to ID and describe outcomes and mortality in a year after ID.
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Missed opportunities for limb salvage in patients undergoing major amputation - a retrospective cohort study of the clinical practice research datalink — Rob Sayers ...
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Missed opportunities for limb salvage in patients undergoing major amputation - a retrospective cohort study of the clinical practice research datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-21
Organisations:
Rob Sayers - Chief Investigator - University of Leicester
Andrew Nickinson - Corresponding Applicant - University of Leicester
Briana Coles - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Matt Bown - Collaborator - University of Leicester
Robert Davies - Collaborator - University Hospitals Of LeicesterOutcomes:
 Cardiovascular mortality (30-day and 1-year) (See Appendix 1)
 All-cause mortality (30-day and 1-year)Description: Technical Summary
The primary aim of this study is to assess primary and secondary care episodes prior to major lower limb amputation for limb ischaemia to investigate if opportunities are present to enable earlier diagnosis and treatment of limb ischaemia and facilitate limb salvage.
Using data collected in the CPRD Gold database with linkage to Hospital Episode Statistics (HES) (admitted care, accident and emergency and outpatient) and ONS death registry, the study will identify a cohort of adult patients who underwent major lower limb amputation for limb ischaemia during 2000-2016. Once identified, primary and secondary care episodes preceding the amputation will be scrutinised to assess if patients underwent cardiovascular assessment. Patients will be stratified into 5 groups - those that underwent their most recent assessment within 1 month, 3 months, 6 months, or 12 months prior to their amputation and those that did not undergo an assessment within the preceding 12 months. Subsequent cardiovascular and all-cause mortality will also be compared for each assessment group.
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Bone pain in primary care patients newly diagnosed with multiple myeloma: a population-based cohort study — Anouchka Seesaghur ...
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Bone pain in primary care patients newly diagnosed with multiple myeloma: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-28
Organisations:
Anouchka Seesaghur - Chief Investigator - Amgen Ltd
Victoria Banks - Corresponding Applicant - Amgen Ltd
David Neasham - Collaborator - Amgen Ltd
Edwin Hoeben - Collaborator - Amgen Ltd
George Kafatos - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Natalia Petruski-Ivleva - Collaborator - Aetion, Inc
Shannon Reynolds - Collaborator - Aetion, IncOutcomes:
Primary: Record of bone pain; time from first-ever bone pain record to MM diagnosis; time from MM diagnosis to first-ever bone pain record; record of CRAB criteria investigations; record of at least 1 confirmatory test result for positive CRAB criteria; number of recorded test results
Secondary: Reproducibility of the primary analysis results using two analytical approaches
Exploratory: Record of bone pain among a subset of patients with a record of SRE(s)
Key variables
Bone pain; Patient demographics  Age; Gender; Length of pre-index time available; Length of follow-up available;
Clinical characteristics - history of diagnosed comorbidities; history of pathological fractures; concomitant medication; CRAB criteria investigations and positive CRAB criteria - hypercalcaemia and confirmed hypercalcaemia; renal impairment and confirmed renal impairment; anemia and confirmed anaemia; imaging for investigating bone and confirmed bone/lytic lesion(s).Description: Technical Summary
Diagnosing symptomatic Multiple Myeloma (MM) is challenging, as it presents with a myriad of symptoms, with non-specific and multiple site symptoms such as bone pain, fatigue, fracture, etc. Given that GPs play a significant role in referrals of newly diagnosed multiple myeloma patients (NDMM), the primary care setting represents an excellent milieu to investigate the aetiology of diagnosis. This is the scientific research focus in this retrospective population-based cohort study in the United Kingdom (UK).
The main aim is to estimate the frequency of presenting initial symptoms of MM patients at their first point of contact with the health care system (within the routine primary care setting) in the UK. The primary objectives are to estimate the proportion of MM patients with a record of bone pain, CRAB criteria investigations (elevated Calcium, Renal Failure, Anaemia, Bone Lesions), and positive CRAB criteria in a cohort of NDMM patients within the primary care setting, and to describe the patients in terms of demographic and clinical characteristics. The secondary objective is to assess the reproducibility of the primary analysis results using two analytical approaches, namely Aetion Evidence Platform and SAS statistical software. Exploratory objectives will explore the primary endpoints in specific sub-cohorts, namely NDMM patients with a record of bone pain and/or skeletal-related events (SREÂs).
This study is descriptive in nature, no formal hypotheses will be tested. Summary statistics will be reported for continuous variables and will include estimates of the mean, with number of observations and standard deviation reported to indicate precision. For categorical variables, proportions will be calculated and numbers of patients in each group will be reported.
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Risk of adverse mental health outcomes in women with a history of breast cancer in the United Kingdom: a population-based matched cohort study — Krishnan Bhaskaran ...
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Risk of adverse mental health outcomes in women with a history of breast cancer in the United Kingdom: a population-based matched cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-07
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helena Carreira - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Esha Abrol - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachael Williams - Collaborator - CPRD
Susannah Stanway - Collaborator - Royal Marsden HospitalOutcomes:
ÂÂ Anxiety
 Depression
 Fatigue
 Cognitive impairment
 Pain
 Sexual dysfunction
 Sleep disorders
 Completed suicide
 Self-harmDescription: Technical Summary
The aim of this study is to estimate the relative risk of anxiety and depression (primary outcomes), and fatigue, pain, sleep disorders, neurocognitive and sexual dysfunctions, and fatal and non-fatal self-harm (secondary outcomes), in breast cancer survivors compared to non-cancer controls. This study will be a matched cohort study, utilising data from the CPRD GOLD primary care database. Outcome-specific algorithms will be developed and validated to ascertain outcomes in the data. Algorithm development will consider Read codes for diagnoses, prescriptions, referrals and symptoms; prevalence and incidence estimates by age-group and sex will be computed for a random sample of patients selected from CPRD GOLD primary care database. Validation will be against external sources of data, namely published data from population-based surveys in the UK. To estimate the associations between breast cancer survivorship and the primary and secondary outcomes, we will ascertain all women exposed to breast cancer in the CPRD GOLD primary care database, and randomly select an age- and primary-care-practice-matched cohort of women without prior cancer in a ratio of 1:4. Cox regression models will be used to estimate hazard ratios adjusted for important confounders, and to explore the role of effect modifiers; the proportionality of hazards will be tested graphically and inferentially.
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Proton pump inhibitor use and the risk of myocardial infarction: a nested case-control study in the UK Clinical Practice Research Datalink. — Susan Jick ...
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Proton pump inhibitor use and the risk of myocardial infarction: a nested case-control study in the UK Clinical Practice Research Datalink.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-13
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Ellen Qian - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
1. Primary outcome: diagnosis of myocardial infarction in the CPRD
2. Secondary outcome for sensitivity analysis: diagnosis of MI with supporting evidence, such as hyperlipidemia, atherosclerosis, the use of antiplatelet and antihypertensive mediations.Description: Technical Summary
Proton pump inhibitors (PPIs) were introduced to the market in 1989 primarily to treat gastroesophageal reflux disease (GERD) and peptic ulcer disease. Since their introduction, multiple studies have shown that exposure to PPIs among high-risk cardiovascular patients with concomitant use of antiplatelet medication (e.g. clopidogrel) is associated with an increased risk of cardiovascular events. However, little is known about whether PPIs increase the risk of myocardial infarction (MI) among generally healthy populations.
Our aim is to evaluate the association between PPI use and risk of developing MI among patients in the CPRD.
We plan to conduct a nested case-control analysis in a population of PPI users. First, we will identify all users of PPIs within the CPRD. From this population, we will identify all cases who had a first MI and match them to up to 4 controls based on age (+/- 2 years), calendar year (+/- 2 years), sex, general practice, and index date (same date as their matched case). We will use conditional logistic regression to estimate crude and adjusted odds ratios and 95% CIs of MI among PPI users, compared with unexposed patients (patients who had their first PPI exposure after the index date).
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An impact evaluation of the Joint Royal College of General Practitioners (RCGP)-Clinical Practice Research Datalink (CPRD) quality improvement initiative — Puja Myles ...
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An impact evaluation of the Joint Royal College of General Practitioners (RCGP)-Clinical Practice Research Datalink (CPRD) quality improvement initiative
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-28
Organisations:
Puja Myles - Chief Investigator - CPRD
Helen Booth - Corresponding Applicant - CPRD
Bruce Guthrie - Collaborator - University of Edinburgh
Eleanor Yelland - Collaborator - CPRD
Rebecca Ghosh - Collaborator - CPRD
Stephen Welburn - Collaborator - CPRDOutcomes:
Non-steroidal anti-inflammatory drugs (NSAIDs)
- Antidepressants
- Thiazolidinediones (glitazones)
- Antipsychotics
- Aspirin without an anticoagulantDescription: Technical Summary
The RCGP and CPRD launched a collaborative quality improvement (QI) pilot project in 2015 to explore the potential of using CPRD data to help general practitioners (GPs) improve patient care. Practices contributing data to CPRD are sent confidential bespoke practice level feedback on prescribing safety indicators including lists of patients who may need review. The aim of this study is to evaluate the impact of the QI initiative on the targeted prescribing using segmented regression analysis of interrupted time-series data with estimation of absolute and relative change at pre-specified times after the interruption/intervention. To address potential misspecification of the interruption period, a Joinpoint regression analysis will also be conducted as a sensitivity analysis. The outcomes will be change in the proportion of patients particularly vulnerable to adverse drug effects (because of age, comorbidity or co-prescribing) who are prescribed non-steroidal anti-inflammatory drugs (NSAIDs), thiazolidininediones (glitazone), aspirin without an anticoagulant, antidepressants and antipsychotics. These outcomes encompass the prescribing targeted by the first six indicators covered in the reports.
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Estimating the incidence of acute complications of herpes zoster: a matched cohort study using UK healthcare data — Harriet Forbes ...
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Estimating the incidence of acute complications of herpes zoster: a matched cohort study using UK healthcare data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-19
Organisations:
Harriet Forbes - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Morton - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sara Thomas - Collaborator - Not from an Organisation
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Victor Hu - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary
 Zoster-related dermatological complications
 Zoster-related neurological complications
 Zoster-related visceral/systemic complications
 Zoster-related ophthalmic complicationsSecondary
 Individual conditions which collectively comprise the primary outcomes
 Zoster-related mortality
 Zoster-related hospitalisationDescription: Technical Summary
Herpes zoster can have serious complications, beside postherpetic neuralgia, many of which are severe, life-threatening and costly to the healthcare system. However, data on their incidence and their risk factors is limited. The objective of this research is therefore to estimate the incidence of acute complications following zoster and to estimate the effectiveness of the Zostavax vaccine against these complications.
We will first carry out a cohort study among individuals with zoster, matched on age, sex and practice, to ten patients without zoster. We will fit Cox models, with current age as the underlying time-scale, to obtain hazard ratios for our outcomes in patients with and without zoster, adjusting for covariates, within the first year of zoster. We will go on to stratify our results on age group, severe immunosuppression and common comorbidities. We will also assess the incidence of and risk of the outcomes according to whether patients were given antiviral treatment within seven days of diagnosis.
We will then use a self-controlled cases series (SCCS) to quantify the relative risks of four zoster attributable acute complications (encephalitis, pneumonia, cellulitis or keratitis). Use of a SCCS design ensures we remove between-person confounding. Conditional Poisson regression will be used to estimate the incidence rate of each outcome during risk periods following zoster and compared with the incidence in baseline periods, adjusted for age.
We will estimate the effectiveness of Zostavax against complications of zoster among the subset of zoster patients who were eligible for zoster vaccination after its introduction on 01/09/2013. Cox regression will be used to assess the overall association between vaccination and outcome and model rates of outcomes by exposure status, adjusting for covariates.
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Changes in lung function over time in a primary care COPD cohort and their relationship with patient demographic, clinical and health-care utilization characteristics — Jennifer Quint ...
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Changes in lung function over time in a primary care COPD cohort and their relationship with patient demographic, clinical and health-care utilization characteristics
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Debbie Jarvis - Collaborator - Imperial College London
Jeanne Pimenta - Collaborator - BioMarin Pharmaceutical Inc.
Peter Burney - Collaborator - Imperial College London
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
1)Â Â Â Â Rate of FEV1 and FVC decline in COPD patients
2) Risk of being a fast FEV1 or FVC declinerDescription: Technical Summary
People with COPD have a faster decline in their lung function than people without COPD. However, little is known about how quickly lung function decline in a primary care cohort in an average COPD patient. Additionally, little is known about the decline in forced vital capacity (FVC). Using a mixed effects linear model, we will investigate decline in lung function in people with prevalent COPD over a 14 year period, we will also model patient characteristics associated with fast or slow lung function decline using logistic regression.
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Disease Burden and Health Care Utilisation and Costs among Patients with Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD) — Jie Ting ...
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Disease Burden and Health Care Utilisation and Costs among Patients with Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-19
Organisations:
Jie Ting - Chief Investigator - Gilead Sciences
Gregory Reardon - Corresponding Applicant - Keck Graduate Institute
Burak Ozbay - Collaborator - Gilead Sciences
Donald McPherson - Collaborator - Newcastle upon Tyne Hospitals NHS Foundation Trust
Gregory Reardon - Collaborator - Keck Graduate Institute
William Rosenberg - Collaborator - Royal Free London NHS Foundation TrustOutcomes:
 NAFLD/NASH prevalence and progression
 NAFLD/NASH-specific fibrosis Stage 3 prevalence and progression
 NAFLD/NASH-specific compensated cirrhosis prevalence and progression
 NAFLD/NASH-specific decompensated cirrhosis prevalence and progression
 NAFLD/NASH-specific hepatocellular cancer prevalence and progression
 NAFLD/NASH-specific liver transplant prevalence and progression
 Utilisation of health services and products
 Costs of health services and product costs (burden of illness)Description: Technical Summary
This study describes and quantifies patterns of liver disease progression and estimates the health and economic burden among patients diagnosed with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) in the United Kingdom. Patients studied have a NAFLD or NASH index event during the observation period from 1 Jan 2007 to 1 July 2017 (earliest date in this range was the index date). Patients will be followed until censoring to determine whether NASH/NAFLD progressed to NASH Fibrosis Stage 3 (F3) or to compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), liver transplant (LT), or death. The number of days until censoring spent in each of these liver disease states will be calculated for by sex and age using survival analysis, with minimal duration cut-off criteria. Healthcare service and product utilisation events associated with each health state or selected comorbidities will be tracked for each patient. Utilisation events will be mapped to reference costs to determine absolute annualized or average monthly costs, and incremental costs for each disease state. Further analyses will describe findings by patient demographics and characteristics, physical assessment measures and comorbid endocrine and cardiovascular conditions. ANOVA (continuous-symmetric distributions), Kruskal-Wallis (continuous-asymmetric), and Chi-Square (categorical) will be used to test for significance of associations. Pairwise comparisons will be applied, adjusting for multiplicity.
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Prescriptions for antibiotics in childhood and risk of inflammatory bowel disease: A matched case-control study in the UK Clinical Practice Research Datalink — Susan Jick ...
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Prescriptions for antibiotics in childhood and risk of inflammatory bowel disease: A matched case-control study in the UK Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-30
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Frederikke Troelsen - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Inflammatory bowel disease (i.e. Ulcerative colitis or CrohnÂs disease)
Description: Technical Summary
Exposure to antibiotics is associated with a temporary disruption of the human gut microflora which could possibly be a risk factor for developing inflammatory bowel disease (IBD). In this matched case-control study, we will count the number of prescriptions for different antibiotics in childhood among patients in the UK Clinical Practice Research Datalink (CPRD) with IBD and compare this number to matched IBD-free controls.
Cases will consist of all patients in the CPRD with a recorded diagnosis of IBD. To be selected as a case, the patients must fulfil the following criteria; 1) at least one prescription for IBD-therapy after the date of IBD-diagnosis, 2) at least 10 years of history in the CPRD prior to the IBD-diagnosis and 3) no prior diagnosis of cancer (except non-melanoma skin cancer), Down Syndrome or diverticular diseases. Based on the same eligibility criteria, we will match the IBD-cases to up to 4 IBD-free controls on age (+/- 2 year), sex, general practice, number of active years in CPRD (within +/- 1 year) and index date (date of their matched case's IBD-diagnosis date). Using conditional logistic regression models, we will estimate the crude and adjusted odds ratios and their 95% confidence intervals for IBD stratified on ever or non-use of antibiotics, number of prescriptions for all antibiotics and number of prescriptions for different types of antibiotics.
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Incidence and management of sudden sensorineural hearing loss in primary and secondary care — Padraig Kitterick ...
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Incidence and management of sudden sensorineural hearing loss in primary and secondary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-26
Organisations:
Padraig Kitterick - Chief Investigator - University of Nottingham
Padraig Kitterick - Corresponding Applicant - University of Nottingham
David Baguley - Collaborator - University of Nottingham
Joe West - Collaborator - University of Nottingham
Lu Ban - Collaborator - University of NottinghamOutcomes:
Sudden hearing loss
Description: Technical Summary
The aim of this study is to characterise the incidence and management of sudden sensorineural hearing loss in primary and secondary care. Using HES-linked CPRD data, a code list for identifying sudden sensorineural hearing loss cases will be used to estimate the incidence of the condition by age, gender, geographic area, socio-economic status, ethnicity, and aetiology. Descriptive analyses will summarise the rates and timing of referral of incident cases to ENT services, rates of treatment with steroids in the primary care setting, and rates of re-presentation for the management of any resulting permanent hearing loss including subsequent onward referral to audiology services. Questionnaires to GPs will validate the coding strategy used to identify incident cases and gather further confirmatory information on treatment and referral events. Analyses of linked HES data will identify treatment episodes in the secondary care setting and the use of imaging for diagnostic purposes.
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Progression of preschool wheeze to school age asthma: English population study 2000 to 2017 — Jennifer Quint ...
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Progression of preschool wheeze to school age asthma: English population study 2000 to 2017
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Sejal Saglani - Collaborator - Imperial College LondonOutcomes:
Preschool wheeze prevalence
- School-age asthma diagnosisDescription: Technical Summary
The objective of this study is to measure, over the past two decades, the prevalence of preschool wheeze (wheeze in children aged under 5 years), describe these children in terms of demographics and relevant clinical features; then estimate the rate of progression to school-age asthma, and the determinants of that progression. Annual prevalence of preschool wheeze will be calculated and stratified by age, gender, and co-diagnosis of asthma using validated asthma Read codes. Patients with be identified by the presence of one or more Read codes for wheeze. Patients will be described in terms of demographics, clinical characteristics, and treatment, at 5 different calendar years (2000, 2005, 2010, 2015 and 2017) to inform on differences over the past two decades. A cohort design will be used to estimate the rate of progression of preschool wheeze to school-age asthma, and the ages at which progression occurs. Determinants that may increase the rate of progression will be assessed; these will include demographics (e.g. age, birth weight), clinical characteristics (e.g. atopy, bronchiolitis), or treatment given (e.g. inhaled steroids). A Poisson regression model will be used to estimate rates for each variables, allowing adjustment for all other covariates.
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Risk of hospitalised Influenza, England, 2000-2017 — Iain Gillespie ...
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Risk of hospitalised Influenza, England, 2000-2017
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-19
Organisations:
Iain Gillespie - Chief Investigator - GlaxoSmithKline - UK
Iain Gillespie - Corresponding Applicant - GlaxoSmithKline - UK
Celine El Baou - Collaborator - GSK
David Webb - Collaborator - GlaxoSmithKline - UK
John Logie - Collaborator - GlaxoSmithKline - UKOutcomes:
Flu hospital admission, as defined by a record of an ICD-10 admission code for influenza (J09*, J10*, J11*)
Description: Technical Summary
This study seeks to generate counts of patients admitted to hospital with influenza in England between 2000 and 2017. Counts will be split further by broad age groups (<18, 18-64 & 65+ years), the primary nature of the hospital admissions (e.g. flu was recorded as the primary reason for hospital admission), the incident nature of the hospital admissions (e.g. if a patients had previous admissions in the 90 days prior to each admission) and whether the admission occurred in flu seasons (nominally week 40 of one year to week 15 of the next) or not. The study will use a CPRD source population to form the denominator on which risk estimates will be calculated. No formal testing will be undertaken.
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Trends in the prescribing of opioids for non-malignant pain in UK primary care: a descriptive study — Katherine Donegan ...
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Trends in the prescribing of opioids for non-malignant pain in UK primary care: a descriptive study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-22
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRA
Craig Allen - Collaborator - MHRA
Jenny Wong - Collaborator - MHRA
Preeti Datta-Nemdharry - Collaborator - MHRA
Stephanie Dellicour - Collaborator - MHRAOutcomes:
Number of patients with at least one opioid prescription during the study period; Number of prescriptions issued during the study period; Strength/Dose of prescription; Duration of opioid treatment. All outcomes will be stratified by opioid drug substance, age, gender and country.
Description: Technical Summary
Public health concerns have been raised regarding the increasing use of opioids for the treatment of non-malignant pain despite the increased risks of tolerance, dependence and addiction. The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a review of the opioid class of medicines to ensure warnings of the risks are sufficient and consistent across the different opioid substances, focusing in the first instance on six opioids with the greatest use and/or the potential for dependence and addiction. The review will also assess whether the current regulatory risk minimisation measures are adequate in view of the increasing use and highlighted risks associated with opioid use. This descriptive study aims to assess trends in the prescribing of specific opioids in UK primary care over the last ten years, including the number of patients and number of opioid prescriptions issued. The average duration of opioid treatment will also be estimated. All patients with a record of at least one opioid prescription between the period 1st October 2008 & 30th September 2018 will be included. Prescriptions in patients with a preceding record of a malignancy in their clinical record will be excluded. This study will provide useful information to inform the MHRA's review and potential need for regulatory action and changes to regulatory risk minimisation measures.
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Do beta adrenoreceptor blocking drugs associate with reduced risk of symptomatic osteoarthritis and total joint replacement in the general population? A Prospective cohort study using the Clinical Practice Research Datalink — Abhishek Abhishek ...
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Do beta adrenoreceptor blocking drugs associate with reduced risk of symptomatic osteoarthritis and total joint replacement in the general population? A Prospective cohort study using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-08
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Georgina Nakafero - Corresponding Applicant - University of Nottingham
Ana Valdes - Collaborator - University of Nottingham
Christian Mallen - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Matthew Grainge - Collaborator - University of Nottingham
Michael Doherty - Collaborator - University of Nottingham
Nick Townsend - Collaborator - University of Bath
Weiya Zhang - Collaborator - University of NottinghamOutcomes:
Knee Osteoarthritis
- Hip Pain
- Analgesic prescription
- Hip Osteoarthritis
- Total Knee Replacement
- Knee Pain
- Total Hip ReplacementDescription: Technical Summary
Objectives: To investigate if ?-blocker prescription associates with reduced risk of symptomatic knee or hip osteoarthritis, total joint replacement, and analgesic prescription.
Methods:
Data source: CPRD
Study design: Cohort study
Cohort1: ?-blocker and incident knee/hip osteoarthritis:
Inclusion criteria: age >/=40 years
Exposed: >/=2 continuous ?-blocker prescriptions
Index date: first date of prescription of ?-blocker
Unexposed: Upto four age, sex, GP surgery and propensity score for ?-blocker prescription matched controls
Exclusion criteria: contra-indications to ?-blockers, consultations for OA or potent analgesic prescription before index date
Outcomes: Knee osteoarthritis (primary outcome), hip osteoarthritis, knee pain, hip pain.
Cohort 2; ?-blockers and total joint replacement and new analgesic prescription
Inclusion criteria: age >/=40 years, knee or hip osteoarthritis, new analgesic prescription.
Exposure and index date: As in Cohort 1.
Unexposed: As in Cohort 1, additionally matched for consultation for knee or hip osteoarthritis or new analgesic prescription prior to index date.
Exclusion criteria: contra-indications to ?-blockers, osteoarthritis at other joints prior to index date.
Outcome: Total knee replacement, total hip replacement, new analgesic prescription.
Statistical analysis: Kaplan Meier curves will be plotted and Cox proportional hazard ratios (HRs) and 95% CIs will be calculated. Stratified analysis will be performed by class of ?-blocker, intrinsic sympathomimetic effect, and indication(s) for prescription.
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A retrospective examination of glaucoma patients in the CPRD database with contraindications for anti-glaucoma beta-blocker therapy — Yong Soo Kim ...
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A retrospective examination of glaucoma patients in the CPRD database with contraindications for anti-glaucoma beta-blocker therapy
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-06
Organisations:
Yong Soo Kim - Chief Investigator - NOVARTIS
Ailis Fagan - Corresponding Applicant - NOVARTIS
Martin McSharry - Collaborator - Optum
Vladimir Bezlyak - Collaborator - NOVARTISOutcomes:
Primary: Patient counts/frequencies for Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) patients with selected cardiovascular and respiratory comorbidities contraindicated for topical beta-blocker use
- Secondary: Patient counts/frequencies for POAG/OHT with selected cardiovascular and respiratory comorbidities in specific time intervals: (i) before POAG/OHT diagnosis, (ii) after diagnosis, (iii) after diagnosis but before topical beta-blocker treatment, (iv) and after topical beta-blocker treatment
- Secondary: the number of topical beta-blocker prescriptions in POAG and OHT patients 6 months after first topical beta-blocker prescription
- Secondary: Patient counts/frequencies for topical beta-blocker treatment line for POAG and OHT patients
- Secondary: Patient counts/frequencies for concurrent use of topical beta-blocker and beta-agonist or systemic beta-blockerDescription: Technical Summary
Objectives:
This study is to elucidate the recent prescribing trends of topical beta-blocker therapy for newly diagnosed Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) patients in the UK. In particular, it will describe whether POAG and OHT patients with contraindicated comorbidities for topical beta-blockers are still receiving topical beta-blocker therapy in spite of explicit guidelines against their use and recent improvements in availability of alternative medications. It will also examine (i) the number of patients diagnosed with contraindicated comorbidities before diagnosis, after diagnosis, after diagnosis but before topical beta-blocker therapy and after topical beta-blocker treatment, (ii) the treatment line for topical beta-blocker treatments, (iii) if the patients are in receipt of concurrent contraindicated treatments and (iv) the number of topical beta-blocker prescriptions in the 6 months after the first topical beta-blocker prescription. An analysis of this data is required to potentially highlight the need for more appropriate treatments to be prescribed for POAG and OHT and to inform a potential prescribing policy change in the UK.
Methods:
This is a descriptive study and therefore no complex statistical methods will be applied. Only descriptive statistics such as frequency counts, percentages, mean, standard deviation, range, median and interquartile range will be reported.
Data analysis:
Patients diagnosed with POAG or OHT between 2013 and 2016 in the CPRD database will be included. This is to assess more recent prescribing trends and to allow at least one year of follow-up data for prescribing patterns.
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Maternal and perinatal characteristics associated with Respiratory Tract Infection (RTI) healthcare utilisation and death in a birth cohort using the CPRD database and other linked databases — Caroline Amand ...
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Maternal and perinatal characteristics associated with Respiratory Tract Infection (RTI) healthcare utilisation and death in a birth cohort using the CPRD database and other linked databases
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-11-05
Organisations:
Caroline Amand - Chief Investigator - Sanofi UK
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement
Clarisse Demont - Collaborator - Sanofi Pasteur MSD ( closed )
Harry Campbell - Collaborator - University of Edinburgh
Rachel Reeves - Collaborator - University of EdinburghOutcomes:
GP consultations for RTI; Hospitalisation for RTI; Outpatient visits for RTI; Death with RTI as cause; Maternal characteristics; Perinatal characteristics; Demographics; Comorbidities
Description: Technical Summary
Respiratory Syncytial Virus (RSV) is the most important cause of viral lower respiratory tract illness in young children worldwide and considered one of the world's greatest unmet vaccine needs. However, current knowledge on the disease is too sparse to underpin evidence-based decision-making on new RSV prevention strategies and therapeutics. Identifying the maternal and perinatal characteristics (such as maternal smoking, type of delivery, breastfeeding status, birthweight, APGAR score (5 mins), mechanical ventilation, and oxygen use) associated with Respiratory Tract Infection (RTI) healthcare utilisation (hospitalisation, outpatient visit, and GP consultation) and death likely due to RSV is key to increasing understanding of the disease.
This objective will be assessed through analysis of data collected in CPRD, linked to Hospital Episode Statistics (HES), pregnancy register, Baby Mother Link, and Office for National Statistics (ONS) death registration data. The study will use a retrospective cohort of all patients eligible for linkage with HES/ONS data born between 2010 and 2015. We will compare the exposed group of patients with associated RTI healthcare utilisation or death (all events, those coded as being due to RSV, and those occurred within the RSV season), relative to the unexposed group of patients without RTI within their 2 years of follow-up. Univariate and multivariate logistic models will be conducted to assess the impact of perinatal and maternal characteristics on RTI profile, and to adjust for other relevant variables e.g. demographics, socio-economics status, and risk conditions.
Source
2018 - 10
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The burden of respiratory disease in people living with HIV infection in the UK Clinical Practice Research Datalink — Fiona Pearce ...
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The burden of respiratory disease in people living with HIV infection in the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-31
Organisations:
Fiona Pearce - Chief Investigator - University of Nottingham
Shanie Wright - Corresponding Applicant - University of Nottingham
Paul Collini - Collaborator - University of Sheffield
Rebecca Mawson - Collaborator - University of Sheffield
Richard Hubbard - Collaborator - University of Nottingham
Tricia McKeever - Collaborator - University of NottinghamOutcomes:
Primary:
Prevalence of Chronic Respiratory disease in people living with HIV compared to the general population.Secondary:
1. Prevalence of current smoking, ex-smoking and non-smoking.
2. Respiratory system related consultation rate, and the prevalence of pulmonary function testing and test results.
3. Prevalence of respiratory symptoms including cough, production of phlegm, wheeze, breathlessness and shortness of breath; and the prevalent use of long term respiratory treatments, in particular inhalers
4. Mortality rates from respiratory diseases.Description: Technical Summary
Objectives:
The overall aim of this project is to quantify the amount of respiratory disease, respiratory symptoms and smoking habit presenting in primary care for PLWH compared to the general population. Our specific research objectives are to establish:
1. The prevalence of recording of people living with HIV in UK primary care
2. The prevalence of records of respiratory disease diagnoses, respiratory symptoms, treatments for respiratory diseases, secondary healthcare service usage for respiratory diseases, and current and ex-smoking in PLWH and matched controls.
3. Causes of death for PLWH compared to matched controls of people without an HIV diagnosis.Methods and data analysis:
a) Cross sectional study to identify all cases of HIV in the CPRD on 1 July 2016 and estimate point prevalence using the whole CPRD as the denominator population. We will estimate the impact of the a priori confounders age, sex and socio-economic status on prevalence using conditional logistic regression.
b) A case-control study using all the cases of PLWH identified above and 4 matched controls comparing the prevalence of current smoking, lung diseases, respiratory symptoms, treatments, consultations and inpatient hospital admissions for respiratory diseases.
c) Cross sectional study comparing the causes of mortality for PLWH who died in each 5-year time band since its inception.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT):Study 15 - Replication of "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events." — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT):Study 15 - Replication of "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events."
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-10
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Occurrence of acute myocardial infarction
Description: Technical Summary
This objective of this protocol is to replicate the study: "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events." by Suissa et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Suissa paper assessed the cardiovascular risk related to concurrent use of more than one bronchodilator (such as long-acting Beta2-agonists (LABAs) and anticholinergics (LAMAs)) to treat COPD compared to treatment with only one bronchodilator using CPRD data between 2002 and 2012. We will focus on replicating the cohort and baseline characteristics as well as the adjusted hazard ratio for risk of acute myocardial infarction within 1 year of follow up.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 13 - Replication of "Metformin and the incidence of viral associated cancers in patients with type 2 diabetes." — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 13 - Replication of "Metformin and the incidence of viral associated cancers in patients with type 2 diabetes."
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-11
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Primary diagnosis of viral associated cancer defined as a composite outcome (including hepatocellular carcinoma, Kaposi sarcoma, T-cell leukaemia, Non-Hodgkin's lymphoma, B and T cell lymphoma, cervical cancer, anal cancer, penile cancer, vaginal cancer, vulvar cancer, oropharyngeal and nasopharyngeal cancer).
Description: Technical Summary
This objective of this protocol is to replicate the study: "Metformin and the incidence of viral associated cancers in patients with type 2 diabetes" by Hicks et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Hicks paper compares the risk of viral associated cancers for patients with type 2 diabetes exposed to metformin between 1988 and 2016. We will focus on replicating the adjusted hazards ratio comparing the risk of viral associated cancers for time varying exposure to metformin. Patients were followed from new initiation of a non-insulin anti-diabetic agent until a first ever diagnosis of viral associated cancers, death from any cause, end of registration with the practice, or end of the study period (March 31, 2016), whichever occurred first. Risk of viral associated cancers was evaluated using a a time-dependent Cox proportional hazards model.
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Assessing the Chronicity and Burden of Hyperkalaemia in Patients with Cardiorenal Comorbidities — Glen James ...
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Assessing the Chronicity and Burden of Hyperkalaemia in Patients with Cardiorenal Comorbidities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-30
Organisations:
Glen James - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Phil McEwan - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Carl Mellström - Collaborator - Astra Zeneca Ltd - UK Headquarters
Carmen Tsang - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Jennifer Kim - Collaborator - Astra Zeneca Ltd - UK Headquarters
Kerrie Ford - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Marc Evans - Collaborator - Llandough Hospital
Nia Jenkins - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )Outcomes:
 Incident hyperkalaemia
 Recurrent hyperkalaemia
 All-cause mortality
 Major adverse cardiovascular event
 Discontinuation of renin-angiotensin-aldosterone system inhibitorsDescription: Technical Summary
Hyperkalaemia is an electrolyte imbalance typically defined as a serum potassium concentration ?5.0 mmol/L, associated with adverse clinical outcomes including major adverse cardiovascular events (MACE), hospitalisation and associated length of stay, and all-cause mortality.
CKD, HF, resistant hypertension and diabetes are significant risk factors for the development of hyperkalaemia, and patients with these comorbidities are at increased risk of experiencing elevated serum potassium. Renin-angiotensin-aldosterone system inhibitors (RAASi) are prescribed to manage such comorbidities but further increase the risk of hyperkalaemia.
Recently published real-world studies have largely examined associations between hyperkalaemia and adverse clinical outcomes in relatively narrowly-defined patient populations. Furthermore, there is a relative paucity of studies that elucidate risk factors for hyperkalaemia itself and, where such studies do exist, it is currently unclear whether their results generalise to alternative patient populations and healthcare systems.
This real-world study aims to explore the patterns of hyperkalaemia, including its chronicity and burden, in a broad population of patients with cardiorenal comorbidities and at elevated risk of hyperkalaemia. The study also aims to assess the generalisability of existing risk equations for predicting the incidence of adverse clinical outcomes as a function of serum potassium in patients with established cardiorenal comorbidities.
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SELECT: Selection of Eligible People for Lung Cancer Screening using Electronic Primary Care DaTa: Development of new risk prediction models — David Baldwin ...
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SELECT: Selection of Eligible People for Lung Cancer Screening using Electronic Primary Care DaTa: Development of new risk prediction models
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-29
Organisations:
David Baldwin - Chief Investigator - Nottingham University Hospitals
David Baldwin - Corresponding Applicant - Nottingham University Hospitals
David J. Brown - Collaborator - Nottingham Trent University
Emily Peach - Collaborator - University of Nottingham
Emma O'Dowd - Collaborator - University of Nottingham
Graham Ball - Collaborator - Nottingham Trent University
Harry de Konig - Collaborator - Erasmus University Medical Center ( EMC )
Helen Morgan - Collaborator - University of Nottingham
Jaspreet Kaur - Collaborator - University of Nottingham
John Field - Collaborator - University of Liverpool
Jun He - Collaborator - Nottingham Trent University
Kevin ten Haaf - Collaborator - Erasmus University Medical Center ( EMC )
Libby Ellis - Collaborator - University of Nottingham
Matthew Callister - Collaborator - Leeds Teaching Hospitals NHS Trust
Mufti Mahmud - Collaborator - Nottingham Trent University
Muhammad Rahman - Collaborator - Nottingham Trent University
Rachael Murray - Collaborator - University of Nottingham
Richard Hubbard - Collaborator - University of Nottingham
Sam Janes - Collaborator - University College London ( UCL )
William Hamilton - Collaborator - University of ExeterOutcomes:
Primary:
Can primary care data be used to develop improved risk prediction models for selecting individuals for low dose CT screening for lung cancer?Secondary:
How do these models compare with existing models and currently recommended criteria for screening in terms of sensitivity, specificity, predictive value and cost effectiveness?What proportion of patients diagnosed with lung cancer would have been eligible for screening based on data one or more years prior to their diagnosis?
What is the cost effectiveness of selecting individuals for screening based on the application of these models?Description: Technical Summary
Objectives:
The overall aim of this project is to determine if primary care data can be used to develop improved risk prediction models for selecting individuals for low dose CT screening for lung cancer? Specific research objectives are:
1. To develop a series of mathematical models using data from patients one, two and three years prior to lung cancer diagnosis.
2. To examine for differences between models, including analysis of variation when stratifying lung cancer into early and late stage, pathological subtype and by route to diagnosis.
3. To compare the predictive performance in the external validation datasets and the eligibility rates between the new model(s), the PLCOM2012 and the LLPv2 models over a range of risk thresholds.
4. To assess the cost effectiveness of the models at varying risk thresholds.
Methods and data analysis:
a. A case-control cohort will be identified using all cases of lung cancer linked to data from NCRAS in CPRD and 10 matched controls.
b. Patient demographic features, all symptoms, diagnoses, investigations and drug prescriptions will be identified and used to produce a risk prediction model. This will involve both traditional statistical techniques and a range of machine learning methods.
c. This model will be externally validated and cost effectiveness analysis will be performed using microsimulation modelling.
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Annual healthcare resource utilisation attributable to meningococcal disease (MD) in the UK during the period 2008-2017 Â retrospective database analysis — Caroline Amand ...
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Annual healthcare resource utilisation attributable to meningococcal disease (MD) in the UK during the period 2008-2017 Â retrospective database analysis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-29
Organisations:
Caroline Amand - Chief Investigator - Sanofi UK
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement
Alexia Kieffer - Collaborator - SANOFI
Helene Bricout - Collaborator - Sanofi Pasteur MSD ( closed )Outcomes:
Demography
- High-risk conditions
- Complications / long term sequelae
- Medication
- Meningococcal-attributable healthcare utilisationDescription: Technical Summary
Objectives: This study aims to describe the annual healthcare resource utilisation attributable to meningococcal disease in the UK during the period 2008-2017, through analysis of data collected in CPRD, linked to hospital care consultations and death records.
Methods: A matched case control study will be conducted. Patients with an event of meningococcal disease will be identified between January 2009 and December 2016, and will be individually matched with up to four randomly selected controls on: age, gender, region, and index date for meningococcal. The index date will be defined as the first meningococcal episode during this period. Baseline period will be defined by 12-month (for patients aged ? 1 year) pre-index date and follow-up period by 12 months after index date. Continuous enrolment of 1 year over baseline and follow-up and HES eligibility will be required to be eligible for inclusion.
Analysis: Descriptive analysis will be conducted on demographics, Charlson comorbidities, high-risk conditions, sequelae, treatment patterns, and healthcare utilisation. All these parameters will be described in case and control cohorts and stratified by age groups. Meningococcal-attributable resource utilisation will be assessed based on the incremental differences between the cases and controls using multivariate analysis.
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Antibiotic use and the risk of rheumatoid arthritis: a population-based case-control study — Christian Mallen ...
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Antibiotic use and the risk of rheumatoid arthritis: a population-based case-control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-24
Organisations:
Christian Mallen - Chief Investigator - Keele University
Sara Muller - Corresponding Applicant - Keele University
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ian Scott - Collaborator - Keele University
Lindsay Hall - Collaborator - Quadram Institute
Samantha Hider - Collaborator - Keele University
Toby Helliwell - Collaborator - Keele UniversityOutcomes:
Incident rheumatoid arthritis
Description: Technical Summary
An association between antibiotic use and certain autoimmune conditions (e.g. inflammatory bowel disease) has been suggested, however it is not clear if antibiotics are associated with the onset of rheumatoid arthritis. If such an association exists, then antibiotic use could be potentially considered as a modifiable risk factor for RA, especially in primary care where such drugs are overprescribed. The proposed study will 1) assess risk of RA among those prescribed one or more courses of antibiotics; 2) assess the association between antibiotic type (bacteriostatic or bactericidal) and RA.
Method and data analysis
We will identify individuals with first ever recorded diagnosis of RA between 1990 and 2018 using Read codes. Each case will be individually matched to 5 controls on year of birth, gender and general practice and assigned an index date corresponding to the date of their matched case. Exposure will be defined as any systemic antibiotic prescription recorded more than one year before the index date. Conditional logistics regression will be used to assess the association between antibiotic exposure and the risk of incident RA. We will adjust our estimates for a wide range of confounding factors using a multivariable regression model.
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Investigating the cost-effectiveness of interventions to reduce hazardous prescribing associated with antithrombotic drugs in primary care. — Rachel Elliott ...
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Investigating the cost-effectiveness of interventions to reduce hazardous prescribing associated with antithrombotic drugs in primary care.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-11
Organisations:
Rachel Elliott - Chief Investigator - University of Manchester
Leonie Brinkmann - Corresponding Applicant - University of Manchester
Bruce Guthrie - Collaborator - University of Edinburgh
Daniel Morales - Collaborator - University of Dundee
Darren Ashcroft - Collaborator - University of Manchester
Elizabeth Camacho - Collaborator - University of Manchester
Georgios Gkountouras - Collaborator - University of Manchester
Hayley Gorton - Collaborator - Not from an Organisation
Jack Wilkinson - Collaborator - University of Manchester
Jill Stocks - Collaborator - University of Manchester
Niels Peek - Collaborator - University of Manchester
Sean Gavan - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of Manchester
Tony Avery - Collaborator - University of NottinghamOutcomes:
Bleeding (primary outcome)
- Stroke
- Individual drug and regimen adherence and persistence
- Mortality
- Primary care utilisation
- Myocardial infarction
- Secondary care utilisationDescription: Technical Summary
Antithrombotic treatments, such as oral anticoagulants (OACs) and antiplatelets, are highly effective in reducing cardiovascular risk. However, due to the mechanism of action, bleedings are likely. Bleeding events, such as gastrointestinal (GI) bleeds or intracranial haemorrhages (ICH), are rare but have a huge impact on patient's quality of life and treatment costs. Hazardous or erroneous prescribing of antithrombotics, which will be referred to as hazardous prescribing events (HPEs), is associated with an increased risk of bleeding and mortality. This study will analyse specific HPEs defined by a set of patient safety indicators (PSIs). The PSIs are used in interventions that aim to reduce HPE. To analyse the cost-effectiveness of these interventions information on HPE prevalence, associated harm and costs are required. Evidence on harm for the patient and costs related to HPEs is sparse. Therefore, this study will undertake a retrospective cohort analysis to estimate the incidence of harm including bleeding events, mortality and NHS costs associated with HPEs using linked primary and secondary healthcare datasets. Probabilities of bleeding events, mortality and resource use will be used to generate input parameters for an economic model which will estimate the overall economic impact of hazardous prescribing in this context.
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Development and validation of a prognostic model for use in primary care which estimates the probability of individuals with non-diabetic hyperglycaemia developing type 2 diabetes — Laura Gray ...
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Development and validation of a prognostic model for use in primary care which estimates the probability of individuals with non-diabetic hyperglycaemia developing type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-24
Organisations:
Laura Gray - Chief Investigator - University of Leicester
Laura Gray - Corresponding Applicant - University of Leicester
Briana Coles - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
Progression to Type 2 diabetes
Description: Technical Summary
It is estimated that five million people have non-diabetic hyperglycaemia (HbA1c 42-47 mmol/mol (6.0-6.4%) or fasting plasma glucose 5.5-6.9 mmol/l) in England. Epidemiological studies show that only some of these people will progress to Type 2 Diabetes (T2DM). The NHS Diabetes Prevention Programme is currently open to all those with non-diabetic hyperglycaemia. We aim to develop and validate a prognostic model which calculates the risk of developing T2DM in those with non-diabetic hyperglycaemia, using factors such as glucose level, body mass index, age, ethnicity, smoking status, medications, blood pressure, history of cardiovascular disease, family history of type 2 diabetes. To derive the prognostic model, we will use data from primary care medical records from the Clinical Practice Research Datalink to fit a time to event model with time to T2DM as the dependent variable (using either a Cox proportional hazards model or a flexible parametric model). We will assess risk of T2DM at a clinically-relevant time points (5- and 10-year risk) and validate the model using bootstrapping. The baseline survival and coefficients from the final model will be used to form the prognostic score. This score could then be used to target diabetes prevention programmes to those at greatest risk.
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Incretin-based drugs and the risk of lung cancer in patients with type 2 diabetes — Samy Suissa ...
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Incretin-based drugs and the risk of lung cancer in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Julie Rouette - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Nathaniel Bouganim - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Incident diagnosis of lung cancer.
Description: Technical Summary
Incretin-based drugs, which include dipeptidylpeptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists, are second- to third-line therapies used in the treatment of type 2 diabetes. While these drugs have been associated with a lower risk of hypoglycaemia and favourable effects on body weight, they may also have an effect on lung tissue, raising the concern that long-term use may be associated with an increased risk of lung cancer. While trials reported imbalances of this adverse event between randomized groups, these trials were not designed or powered to assess this safety outcome. Thus, to address this question, we will assemble a cohort of approximately 150,000 patients newly-treated with antidiabetic drugs between January 2007 and March 2017. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of lung cancer associated with use of DPP-4 inhibitors and GLP-1 receptor agonists, compared with use of other second-to-third line antidiabetic drugs. Secondary analyses will assess whether the risk varies by duration of use and individual type of incretin-based drug.
Source - and 11 more projects — click to show
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Determine the association between RSV/bronchiolitis episodes in young children and subsequent childhood episodes of wheeze and asthma (up to age 10 years), using a birth cohort — Caroline Amand ...
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Determine the association between RSV/bronchiolitis episodes in young children and subsequent childhood episodes of wheeze and asthma (up to age 10 years), using a birth cohort
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-31
Organisations:
Caroline Amand - Chief Investigator - Sanofi UK
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement
Clarisse Demont - Collaborator - Sanofi Pasteur MSD ( closed )
Harry Campbell - Collaborator - University of Edinburgh
Rachel Reeves - Collaborator - University of EdinburghOutcomes:
Hospitalisation for Bronchiolitis, Wheeze, and Asthma; Outpatient visit for Bronchiolitis, Wheeze, and Asthma;
Primary care episode for Bronchiolitis, Wheeze, and Asthma; Death for Wheeze and Asthma as cause; Demographics; Comorbidities; Maternal characteristics; Perinatal characteristicsDescription: Technical Summary
Respiratory Syncytial Virus (RSV) is the most important cause of lower respiratory tract illness in young children worldwide and considered one of the world's greatest unmet vaccine needs. However, the current knowledge on the disease is insufficiently detailed to underpin evidence-based decision-making on new RSV prevention strategies and therapeutics.
This study will determine the association between RSV/bronchiolitis episodes in young children and subsequent childhood episodes of wheeze and asthma (up to age 10 years) through analysis of data collected in CPRD, linked to Hospital Episode Statistics (HES), pregnancy register, Baby Mother Link, and Office for National Statistics (ONS) death registration data. A retrospective cohort of all eligible patients for linkage with HES/ONS data, born between 2001 and 2007, will be used. The exposed group will consist of all those with a bronchiolitis event (all events, those coded as being due to RSV, those within the RSV season), relative to those without bronchiolitis within their 2 years of follow-up defined as the unexposed group. Kaplan Meier analysis will be conducted to assess the impact of bronchiolitis exposure before the 2 years old on the occurrence of the first events defined by asthma or wheeze episode. Multivariate cox models will be performed to adjust for other relevant variables e.g. demographics, socio-economics status, risk conditions, perinatal and maternal characteristics.
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Burden of meningococcal disease (MD) in the UK during the period 2008-2017 - retrospective database analysis — Caroline Amand ...
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Burden of meningococcal disease (MD) in the UK during the period 2008-2017 - retrospective database analysis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-29
Organisations:
Caroline Amand - Chief Investigator - Sanofi UK
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement
Alexia Kieffer - Collaborator - SANOFI
Helene Bricout - Collaborator - Sanofi Pasteur MSD ( closed )
Moe Kyaw - Collaborator - SANOFIOutcomes:
Objective 1: Epidemiology of meningococcal disease in the UK during the period 2008-2017
- Annual incidence rates of meningococcal disease (by year, age group and setting)
- Annual mortality rate due to meningococcal disease (by year and age group)
- Demographic characteristics of meningococcal disease at acute and follow up periods and deathsObjective 2: Disease burden of meningococcal disease in the UK during the period 2008-2017
- Demographics characteristics at the index event
- High-risk conditions
- Occurrence of related complication and sequelae after the initial meningococcal infectionDescription: Technical Summary
Objectives: This study to describe the burden of meningococcal disease (MD) in the UK and the associated health care resources utilisation to better inform vaccination policy and health economic evaluation; from acute events to long term consequences of the disease.
Methods: We will use a cohort study design to retrospectively describe the incidence and the mortality rate due to MD in the UK between 2008 and 2017 using data from CPRD, HES, and mortality registry data.
To assess the occurrence of related-sequelae, a matched case-control study will be conducted. Patients with an event of MD will be identified during 2009-2017, and will be individually matched with up to four randomly selected controls, on age, gender, region, and index date for meningococcal and follow-up duration. Index date will be defined as the first meningococcal episode during this period. Baseline period will be defined by 12-month pre-index date and will be required to be eligible for inclusion for patients aged >/= 1 year. Follow-up period will be defined by all the reliable data available after index date.Analysis: Incidence and mortality of MD will be described by age groups. The occurrence of sequelae will be analysed using Kaplan Meier curves; and multivariate analyses using Cox regression.
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SGLT-2 Inhibitors and the Risk of Community-acquired Pneumonia — Samy Suissa ...
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SGLT-2 Inhibitors and the Risk of Community-acquired Pneumonia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Laurent Azoulay - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Vanessa Brunetti - Collaborator - McGill UniversityOutcomes:
Diagnosis for community acquired pneumonia
- Hospitalization for community acquired pneumonia
- Lower respiratory tract infectionsDescription: Technical Summary
Sodium-glucose co-transporter-2 (SGLT-2) inhibitors are a novel class of antidiabetic drugs. While these drugs achieve their benefits by inhibiting SGLT-2, they also have variable affinities for sodium-glucose co-transporter 1 (SGLT-1) that is found in the lung. SGLT-1 inhibition in rat alveolar cells has been shown to increase surface liquid glucose concentration, which translates directly to increased proliferation of pathogenic bacteria. This mechanism is analogous to that behind their increased risk of genital and urinary tract infections with SGLT-2 inhibitors. However, to our knowledge, no study has examined the risk of community-acquired pneumonia of SGLT-2 inhibitors in a real-world setting.
This study will examine the risk of community-acquired pneumonia with SGLT-2 inhibitors using the CPRD linked to hospitalization data. The primary endpoint will be a diagnosis of community-acquired pneumonia. We will use time-dependent Cox proportional hazards models to compare event rates with current use of SGLT-2 inhibitors to those with current use of dipeptidyl peptidase-4 (DPP-4) inhibitors. Secondary analyses will examine if SGLT-2 inhibitors are associated with the risk of hospitalization for community-acquired pneumonia and if the risks differ by SGLT-2 inhibitor molecule, by duration of current use, by dose, by history of respiratory conditions, and by age.
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Patient and practice level factors associated with influenza vaccine uptake among adults in England: a 7-year multi-level retrospective cohort study — Paul Grootendorst ...
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Patient and practice level factors associated with influenza vaccine uptake among adults in England: a 7-year multi-level retrospective cohort study
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation Domains
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-31
Organisations:
Paul Grootendorst - Chief Investigator - University of Toronto
Matt Loiacono - Corresponding Applicant - Sanofi Pasteur SA
Ayman Chit - Collaborator - Sanofi Pasteur SA
Edward Thommes - Collaborator - Sanofi Pasteur SA
Helene Bricout - Collaborator - Sanofi Pasteur MSD ( closed )
Luke Skinner - Collaborator - Sanofi Pasteur SA
Matt Loiacono - Collaborator - Sanofi Pasteur SA
Paul Grootendorst - Collaborator - University of Toronto
Rob van Aalst - Collaborator - Sanofi Pasteur SA
Salaheddin Mahmud - Collaborator - University of ManitobaOutcomes:
Primary outcome  patient receives a seasonal influenza vaccine (per season)
Description: Technical Summary
The UK's seasonal influenza vaccine uptake rate amongst adults 65 and over represents some of the highest in Europe, yet uptake rates amongst at-risk adults below 65 are sub-optimal. These uptake rates have remained relatively stagnant for nearly two decades. To better understand this varied performance, we aim assess the association between various patient and practice with seasonal vaccine uptake. We have designed a 7-year multi-level retrospective cohort study amongst adults aged 18 and over in England. The use of the English data permits the linkage of patient level socioeconomic data to our cohort. After applying our detailed inclusion and exclusion criteria, we have identified ~3.3 million eligible patients, constituting our dynamic reference study cohort from which analytical cohorts will be built. These criteria ensure that patients are followed for an adequate amount of time, to more accurately assess their characteristics and outcomes. Seven seasonal cross-sectional cohorts will be constructed, where patients are observed for one full season. The primary outcome is whether or not a patient receives a seasonal influenza vaccine in a given season. Secondly, a longitudinal cohort will be constructed, consisting of patients continuously followed for 7 years (2010-2017). The primary outcome is whether or not a patient receives an influenza vaccine during within each season. Odds Ratios (ORs) of vaccination will be estimated via General Estimating Equation (GEE) Logistic Regression models, adjusting for clustering at the practice level (cross-sectional analysis) as well as within-patient correlation (longitudinal analysis). All models will adjust for patient and practice level factors encompassing areas including demographic characteristics, at-risk health conditions, socioeconomic indicators, living arrangements, pneumococcal vaccine uptake, practice-level vaccine promotion, and practice-level advising of vaccination. A secondary analysis will assess differences in characteristics between practices in the top and bottom 10% of vaccine uptake rates, when stratified by at-risk categories.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT):Study 15 - Replication of "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events." — Jeremy Rassen ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT):Study 15 - Replication of "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events."
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-30
Organisations:
Jeremy Rassen - Chief Investigator - Aetion, Inc
Shirley Wang - Corresponding Applicant - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Occurrence of acute myocardial infarction
Description: Technical Summary
This objective of this protocol is to replicate the study: "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events." by Suissa et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Suissa paper assessed the cardiovascular risk related to concurrent use of more than one bronchodilator (such as long-acting Beta2-agonists (LABAs) and anticholinergics (LAMAs)) to treat COPD compared to treatment with only one bronchodilator using CPRD data between 2002 and 2012. We will focus on replicating the cohort and baseline characteristics as well as the adjusted hazard ratio for risk of acute myocardial infarction within 1 year of follow up.
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Respiratory Syncytial Virus (RSV) healthcare burden in England during the period 2007-2017 — Caroline Amand ...
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Respiratory Syncytial Virus (RSV) healthcare burden in England during the period 2007-2017
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-31
Organisations:
Caroline Amand - Chief Investigator - Sanofi UK
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement
Clarisse Demont - Collaborator - Sanofi Pasteur MSD ( closed )
Harry Campbell - Collaborator - University of Edinburgh
Rachel Reeves - Collaborator - University of EdinburghOutcomes:
RSV-attributable burden of GP consultations for respiratory/cardiorespiratory diseases; RSV-attributable burden of hospitalisations for respiratory/cardiorespiratory diseases; RSV-attributable burden of outpatient visits of respiratory/cardiorespiratory diseases; RSV-attributable mortality for respiratory/cardiorespiratory diseases; Antibiotic prescription attributable to RSV.
GP consultations for respiratory tract infections (RTI); Hospitalisation for RTI; ICU admission for RTI; Outpatient visits for RTI; Death for RTI.Description: Technical Summary
Respiratory Syncytial Virus (RSV) is the most important cause of lower respiratory tract illness in young children worldwide and considered one of the world's greatest unmet vaccine needs. However, the current knowledge on the disease is insufficiently detailed to underpin evidence-based decision-making on new RSV prevention strategies and therapeutics. Estimating the national burden of disease due to RSV is not straightforward. A reliable diagnosis of RSV infection relies on the detection of RSV in respiratory secretions, but this laboratory testing is not mandatory. However, laboratory surveillance data exist in England and are used to evaluate temporal patterns of respiratory pathogens.
This study will estimate the RSV attributable burden of respiratory and cardiorespiratory disease in all age groups and certain risk groups (e.g. children and those chronic medical conditions) using population-level time-series modelling with laboratory surveillance data.
This study will also estimate the health care burden of respiratory tract infections (RTIs) likely due to RSV in young children (<5 years) (i.e. without laboratory confirmation). The healthcare burden will be based on GP episodes, prescriptions, secondary care contacts and mortality.
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Incidence of Cervical Intraepithelial Neoplasia (CIN) among women aged 18 years and above in the UK between 2000 and 2017 — Georges Van Kriekinge ...
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Incidence of Cervical Intraepithelial Neoplasia (CIN) among women aged 18 years and above in the UK between 2000 and 2017
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-08
Organisations:
Georges Van Kriekinge - Chief Investigator - GSK Vaccines
Emmanuel ARIS - Corresponding Applicant - GSK
Germain Lonnet - Collaborator - GSK
Nathalie Servotte - Collaborator - GSKOutcomes:
Primary health outcomes:
- new Cervical Intraepithelial Neoplasia (CIN) all grades
- new Cervical Intraepithelial Neoplasia Grade 1 (CIN I)
- new Cervical Intraepithelial Neoplasia Grade 2 (CIN II)
- new Cervical Intraepithelial Neoplasia Grade 3 (CIN III)Secondary health outcomes:
- duration between the 1st CIN (I, II or III) and the last reported CIN (I, II, III or unspecified)
- CIN (All grades) related hospitalisations or GP visits
- CIN related resources use (interventions/treatment)Description: Technical Summary
The aim of this study is to estimate the incidence of CIN lesions (All grade, Grade I, II or III) among women aged 18 years and above in the UK subjects contained the CRPD database (data release version Q2 2018 or newer), the CPRD-Linked HES Admitted Patient Care and the CPRD-Linked ONS data. The period of analysis will range from January 1st, 2000 to December 31st, 2017. Incidence will be estimated by year and age category. In addition, time of evolution of CIN lesions from the first CIN obtained to the last CIN obtained will be assessed by evaluating time between new CIN episodes and the one previously reported. Finally the number of healthcare visits/use during 2 years after the first diagnosis of a CIN will be tabulated to evaluate the burden of disease linked to the infection.
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Dravet and Lennox-Gastaut Syndromes in the U.K.: epidemiology, patient pathways and costs. — Monique Martin ...
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Dravet and Lennox-Gastaut Syndromes in the U.K.: epidemiology, patient pathways and costs.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-23
Organisations:
Monique Martin - Chief Investigator - Not from an Organisation
Monique Martin - Corresponding Applicant - Not from an Organisation
Florence Bianic - Collaborator - Syneos Health ( inVentiv Health Clinical )Outcomes:
Prevalence of Dravet syndrome
- Specialist's referrals
- Mortality rates
- Prevalence of Lennox-Gastaut syndrome
- GP Visits
- Causes of Mortality
- Prescription of treatments
- Hospitalisations of patientsDescription: Technical Summary
The study objectives are (1) to estimate the prevalence by age groups suffering from DS or LGS; (2) to study treatment pathways; (3) to evaluate the financial burden of medical care of these two conditions; (4) to estimate the mortality rates by age groups and causes of death of DS and LGS patients.
Using the Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES) and Office National Statistics (ONS) Death Registration, we will study the patients with a coded general practitioner (GP) diagnosis of DS and those with a coded diagnosis of LGS. Since these two conditions are difficult to diagnose and can be miscoded by the GP, we will also focus on patients using some specific treatments (from CPRD only as no treatment information is available from HES data)
The main analyses will consist in evaluating the prevalence of the two conditions in adult and children populations. Resource use for both inpatient (number of stays and length of stay, etc.) and outpatient (prescription items, referral visits, etc.) will be estimated for these patients.
Finally, these estimates will be scaled up to the entire population and will be used to evaluate the financial burden of medical care of DS and LGS in the UK.
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Burden of Hypereosinophilic syndrome (HES) in the UK — Melissa Van Dyke ...
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Burden of Hypereosinophilic syndrome (HES) in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-24
Organisations:
Melissa Van Dyke - Chief Investigator - GSK
Gema Requena - Corresponding Applicant - GlaxoSmithKline - UK
Daniel Gibbons - Collaborator - GSK
John Logie - Collaborator - GlaxoSmithKline - UK
Jolyon Fairburn-Beech - Collaborator - GSKOutcomes:
Incidence of Hypereosinophilic syndrome (HES)
- Prevalence of Hypereosinophilic syndrome (HES)Read code=D403500; Description: Hypereosinophilic syndrome
Description: Technical Summary
Hypereosinophilic syndrome (HES) is a very rare disease, characterised by a marked eosinophilia sustained over time that may cause organ damage and/or dysfunction. Reliable estimates of the incidence and prevalence of this disease are not readily available, and there is scarce information about the patients who are suffering from it. This study aims to investigate the burden of disease of HES in the UK, using routinely collected health information from the Clinical Practice Research Datalink (CPRD) and characterise those patients according to demographics, common co-morbidities and medications. During the study period, from 2010 to 2018, we will estimate incidence rates and prevalence of HES per calendar year. Then, we will describe demographic characteristics of these patients. Lastly, we will describe the most frequently recorded co-morbidities and the most frequently prescribed medications in the year before the first recorded HES diagnosis and in the year after.
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A cross sectional description of prostate cancer subgroups — Billy Sagoo ...
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A cross sectional description of prostate cancer subgroups
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-02
Organisations:
Billy Sagoo - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Billy Sagoo - Corresponding Applicant - Astellas Pharma Europe Ltd. - UK
Amanda Hart - Collaborator - Astellas Pharmaceuticals
Chad Dau - Collaborator - Astellas Pharma Europe Ltd. - UK
Sasha Hazaray - Collaborator - Astellas Pharma Europe Ltd. - UKOutcomes:
In this study, we aim to report the number prostate cancer patients by clinical state (point prevalence), report key characteristics at the clinical state level, progression to other states 12months later, and the healthcare resource use in those 12months. The clinical states are primary diagnosis, hormone sensitive with/without metastasis, castrate resistance with/without metastasis and all-cause mortality.
Description: Technical Summary
This is a descriptive study of pca patients using the CPRD, HES and ONS. The aim of this study is to identify prevalent pca patients by clinical states: primary diagnosis, hormone sensitive with/without metastasis, castration resistant with/without metastasis, and all-cause mortality.
The frequency and proportion of pca patients in each clinical state at the beginning of the calendar year and their movement to clinical states by the end of the year will be reported along with their key characteristics such as age and number of hospital inpatient visits.For patients in the non-metastatic castration resistant state, a stratification analysis will be performed based on speed of disease progression, i.e. patients that took less than 6 months and those that took 6months or more to enter this state.
Sensitivity analysis will be also carried out in order to account for potential censored data and missing covariate data. Details of statistical analysis are described in section N.
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The treatment pathway for female patients diagnosed with breast cancer and differences due to lifestyle factors: A cohort study using the Clinical Practice Research Datalink — Rachael Williams ...
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The treatment pathway for female patients diagnosed with breast cancer and differences due to lifestyle factors: A cohort study using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-10-11
Organisations:
Rachael Williams - Chief Investigator - CPRD
Jessie Oyinlola - Corresponding Applicant - CPRD
Anthony Matthews - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Eleanor Yelland - Collaborator - CPRDOutcomes:
 Chemotherapy treatment
 Trastuzumab treatmentDescription: Technical Summary
The objective of this retrospective cohort study is to describe the clinical management and treatment of breast cancer patients by mapping the patient pathway and identifying differences in treatment by based on lifestyle factors. Additionally, we will identify the strengths and limitations of the Systemic Anti-Cancer Therapy (SACT) data in terms of what can/ cannot be ascertained by conducting a study
Incident breast cancer patients will be defined based on ICD-10 and Read coded information in a patientÂs primary care and/ or cancer registration record and grouped according to cancer severity and subtype. They will then be followed up from their first symptom within the study period (from 01 Jan 2014 until the end of the latest database build). The outcomes of interest (which will be defined using primary care, hospital, cancer registration and treatment data) will include the proportion of patients who receive different types of treatment, the average time between each step in the patient pathway, the proportion of breast cancers detected by screening, number of outpatient visits, etc. These analyses will be stratified by several factors including, age, ethnicity, body max index, Smoking status, alcohol status, etc.
We will also explore differences in receipt and dose of systemic treatment received by breast cancer patients based on BMI, alcohol and smoking status using logistic regression.
Source
2018 - 09
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Mortality trends in people with and without type 2 diabetes in UK: a CPRD observational study — Francesco Zaccardi ...
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Mortality trends in people with and without type 2 diabetes in UK: a CPRD observational study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-09
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Joanne Miksza - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Suping Ling - Collaborator - University of LeicesterOutcomes:
All-cause mortality
- Cardiovascular mortality
- Cancer mortalityDescription: Technical Summary
Using data collected in the Clinical Practice Research Datalink (CPRD) Gold database with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS), we will investigate changes in the mortality rate of diabetic patients in the time period 1998 - 2018 and compare these to non-diabetic patients. The cohort will include diabetic participants identified within CPRD (exposed participants) along with a randomly selected sample of one million non-diabetic patients (non-exposed participants). The outcomes are all-cause, cardiovascular and cancer deaths, identified via linkage to ONS. All-cause and cause-specific (cardiovascular and cancer) mortality rates will be estimated by age, sex, and calendar time in subjects with and without diabetes; then, rate ratio and rate differences between people without and without diabetes will be quantified.
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Difference in Response to Inhaled Corticosteroids between smoking and non-smoking asthma patients. — Emil Loefroth ...
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Difference in Response to Inhaled Corticosteroids between smoking and non-smoking asthma patients.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-10
Organisations:
Emil Loefroth - Chief Investigator - NOVARTIS
Paul McGettigan - Corresponding Applicant - Novartis Ireland Limited
Abheenava Kumar - Collaborator - Novartis Pharma AG
Himanshu Pradhan - Collaborator - Novartis Pharma AG
Hui Cao - Collaborator - NOVARTIS
Jessica Marvel - Collaborator - Novartis Pharmaceuticals Corporation
Martin McSharry - Collaborator - OptumOutcomes:
Primary: to compare the time to treatment failure from first initiating ICS or ICS/LABA treatment in smoking vs matched non-smoking asthmatic patients.
-Secondary: To compare the annualized rate of moderate/severe exacerbations post ICS or ICS/LABA initiation between smoking and non-smoking asthmatics;
-Secondary: To describe the SABA use in smoking and matched non-smoking asthmatics;
-Secondary: To compare the time to moderate/severe exacerbation between smoking and matched non-smoking asthmatics who initiated an ICS_containing treatment (ICS or ICS/LABA);
-Secondary: To describe the asthma related and all-cause Health Care Resource Utilization of smoking asthmatics and non-smoking asthmatics.Description: Technical Summary
The primary objective is to compare the time to treatment failure from first initiating inhaled corticosteroids (ICS) or fixed dose inhaled corticosteroids/long acting beta agonists (FD ICS/LABA) treatment in smoking asthmatics and matched non-smoking asthmatics. Treatment failure will be defined as increased treatment dose, prescription of additional maintenance therapy, episode of moderate or severe asthma exacerbation or excessive use of short acting beta agonists (SABA).
The secondary objectives are to: compare time to moderate or severe exacerbation between smoking and non-smoking asthmatics; compare annualized rate of moderate or severe exacerbations between smoking and non-smoking asthmatics; describe the asthma related and all-cause health care resource utilization (HCRU) of smoking compare to non-smoking asthmatics; describe SABA use among smoking and non-smoking asthmatics.
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Uptake of pneumococcal and zoster vaccines by clinical risk groups in England — Helen McDonald ...
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Uptake of pneumococcal and zoster vaccines by clinical risk groups in England
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-10
Organisations:
Helen McDonald - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Grint - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health EnglandOutcomes:
Uptake of pneumococcal polysaccharide vaccine
- Uptake of zoster vaccine
- Vaccine-associated varicella-zoster-virus diseaseDescription: Technical Summary
The national immunisation programme in England includes vaccines against pneumococcal disease and against herpes zoster. Pneumococcal polysaccharide vaccine (PPV) is offered to individuals aged 2-64 years in specific clinical risk groups and to all individuals aged 65+ years. The live zoster vaccine is offered to selected older age groups but cannot be given to those with immunosuppression.
National monitoring of vaccine uptake currently involves automatic extraction and uploading of anonymised GP data on vaccine-eligible individuals and their vaccine uptake. Identification of eligible/ineligible individuals for vaccination and their vaccine uptake is based entirely on Read codes, but these codes cannot fully capture specific risk groups such as those with drug-induced immunosuppression.
This study will use anonymised CPRD data (including both medical and drug codes) to better quantify the clinical risk groups for PPV and those ineligible for zoster vaccine and will estimate vaccine uptake in each group. This will provide more robust estimates of PPV uptake in clinical risk groups, and the extent of inadvertent zoster vaccine uptake in the immunosuppressed. As a secondary objective, the proportion inadvertently receiving zoster vaccine who develop varicella-zoster disease after vaccination will also be estimated.
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The Natural History and heterogeneity in progression of Dementia in the United Kingdom — Sheng...
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The Natural History and heterogeneity in progression of Dementia in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-27
Organisations:
Sheng-Chia Chung - Chief Investigator - University College London ( UCL )
Sheng-Chia Chung - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Caroline Dale - Collaborator - University College London ( UCL )
Dionisio Acosta Mena - Collaborator - University College London ( UCL )
Juan Pablo Casas Romero - Collaborator - University College London ( UCL )
Kamran Khan - Collaborator - University College London ( UCL )
Mar Pujades Rodriguez - Collaborator - University of Leeds
Spiros Denaxas - Collaborator - University College London ( UCL )
Valerie Kuan - Collaborator - University College London ( UCL )
William Whiteley - Collaborator - University of EdinburghOutcomes:
Analyses will be restricted to the most common causes of death, hospitalization and consultation in primary care that occur within the NHS.
Objective 1:i) Mortality
- All-cause mortality and Cause of death (ONS)
ii) Non-fatal disease outcomes from secondary care
iii) Non-fatal disease outcomes from primary careObjective 2:
For this objective the health outcomes will be the detailed temporal sequence of events (fatal and non-fatal) experienced by people with dementia. Multiple temporal sequences will be identified, according to key sources of heterogeneity (e.g. dementia sub-type, presence of co-morbidities). Health events included will be limited to those identified for Objective 1.
Description: Technical Summary
The detailed post-diagnosis experience of people with dementia, their interaction with the healthcare system, co-morbidity profile and treatment pathway remain largely unknown. Dementia is widely acknowledged to be heterogeneous disease; however it remains unknown how progression varies between and within sub-types (e.g. Alzheimer's, vascular dementia and rare dementias such as frontotemporal dementia or Lewy body dementia) and how it is influenced by the co-existence of other comorbidities common in older people (e.g. type-2 diabetes, stroke etc.).
In this study we will use electronic health records to track the progression pathway of a large cohort of individuals diagnosed with dementia (N~240,000) using previously validated algorithms for identifying sub-groups of dementia patients in CPRD/HES data. Linkage of primary and secondary care records with cancer and mortality registries will facilitate a detailed description of the post-diagnosis experience of patients and interaction with the healthcare system; their symptoms and complications, prescriptions/ medications received, reasons for hospitalisations, treatments, timing and causes of death.
A better understanding of heterogeneity in dementia progression will yield important information to inform guidelines for treatment and management of dementia patients, improve resource allocation and inform the design of clinical trials by helping to optimise selection of patients with specific profiles.
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Characterization of acute coronary syndrome patients that switch from dual antiplatelet therapy to monotherapy with clopidogrel or aspirin — Christopher Ronk ...
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Characterization of acute coronary syndrome patients that switch from dual antiplatelet therapy to monotherapy with clopidogrel or aspirin
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-09
Organisations:
Christopher Ronk - Chief Investigator - Sanofi Pasteur SA
Christopher Ronk - Corresponding Applicant - Sanofi Pasteur SA
Shalini Girotra - Collaborator - Sanofi US Services Inc
Sumit Verma - Collaborator - Evidera, IncOutcomes:
Change in therapy - primary
- Revascularization- secondary
- Nonfatal myocardial infarction - secondary
- Cardiovascular death - secondary
- Nonfatal stroke - secondary
- Major bleeding - secondaryDescription: Technical Summary
Objective: To describe the characteristics of acute coronary syndrome patients that switch from dual antiplatelet therapy to monotherapy with clopidogrel or aspirin.
Methods: Acute coronary syndrome patients in CPRD will be evaluated to track changes in therapy and subsequent health outcomes.
Analysis: Descriptive statistics will be conducted. The proportion of acute coronary syndrome patients that switch therapies will be calculated. Timing of switching will be calculated. Comorbidities will be characterized.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 7 - Replication of "Antibiotic treatment failure in four common infections in UK primary care 1991-2012: longitudinal analysis" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 7 - Replication of "Antibiotic treatment failure in four common infections in UK primary care 1991-2012: longitudinal analysis"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-20
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Rate of antibiotic treatment failure for four infection classes
Description: Technical Summary
This objective of this protocol is to replicate the study: "Antibiotic treatment failure in four common infections in UK primary care 1991-2012: longitudinal analysis" by Currie et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Currie paper describes the adjusted rate of antibiotic treatment failure for four infection classes (upper respiratory tract infection, lower respiratory tract infection, skin and soft tissue infections, acute otitis media) for patients with monotherapy antibiotic treatment in the UK general population between 1991 and 2012. We will focus on replicating the outcome of rate of antibiotic treatment failure over this time period. Treatment failure was defined as a prescription of a different antibiotic drug within 30 days of the first line antibiotic; GP record of admission to hospital with an infection related diagnosis within 30 days of antibiotic initiation; GP referral to an infection related specialist service within 30 days of initiation; GP record of an emergency department visit within three days of initiation; or GP record of death with an infection related diagnostic code within 30 days of initiation. Descriptive statistics were calculated for each of the infection classes.
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Initiation of Combination Therapy in Type 2 Diabetes Patients with high HbA1c at diagnosis — Rogier Klok ...
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Initiation of Combination Therapy in Type 2 Diabetes Patients with high HbA1c at diagnosis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-09
Organisations:
Rogier Klok - Chief Investigator - Merck & Co., Inc.
Rogier Klok - Corresponding Applicant - Merck & Co., Inc.
Alex Z. Fu - Collaborator - CHEORS
Ankita Kumar - Collaborator - CHEORS
Kamlesh Khunti - Collaborator - University of Leicester
Swapnil Rajpathak - Collaborator - Merck & Co., Inc.Outcomes:
Baseline HbA1C
- Change in Hb1AC at 24 months (exploratory endpoint)
- BMI
- Therapy initiation (mono or combination)
- Baseline demographics (age, sex, race, region)
- T2D duration
- Change in Hb1AC at 12 months (exploratory endpoint)
- Diabetes-related comorbid conditions (e.g. microvascular, macrovascular, depression, etc)
- Charlson comorbidity indexDescription: Technical Summary
The study analysis will include T2DM patients, aged 18 years and older, using the UK Clinical Practice Research Datalink (CPRD) database. The date of first prescription of an antidiabetic agent between January 2010-December 2015 will be the index date. Patients with continuous enrolment in the database one year prior to the index date, having an HbA1c lab value between 3 months before to 2 weeks after index date will be included. Patients will be excluded if they had type 1 diabetes mellitus, other forms of secondary diabetes, gestational diabetes mellitus, or had taken any antidiabetic drugs in the one-year baseline period.
Outcomes will be stratified by baseline HbA1c levels as well as by type of therapy (monotherapy and combination therapy). Patients with prescription for 2 or more different antidiabetic agents in the first month post index date (with at least 1 follow-up prescription for each agent) will be defined as combination therapy initiators.We will evaluate the longitudinal change in HbA1c levels, at 12 months and 24 months from the baseline levels as well the time taken to achieve target HbA1c level of <7%. To evaluate the demographic and clinical differences between monotherapy initiators and combination therapy initiators, descriptive statistics and regression analysis will be used.
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Autoimmune blistering diseases: Incidence, prevalence, co-morbidity and prescription patterns — Sonia Gran ...
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Autoimmune blistering diseases: Incidence, prevalence, co-morbidity and prescription patterns
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-19
Organisations:
Sonia Gran - Chief Investigator - University of Nottingham
Sonia Gran - Corresponding Applicant - University of Nottingham
Joanne Chalmers - Collaborator - University of Nottingham
Julia Hippisley-Cox - Collaborator - University of Oxford
KAREN HARMAN - Collaborator - University of Nottingham
Kim Thomas - Collaborator - University of Nottingham
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
 The reliability of diagnostic codes to identify people with pemphigoid and pemphigus vulgaris
- The prevalence and incidence of bullous pemphigoid and pemphigus vulgaris
- The prevalence of specific co-morbidity in people with bullous pemphigoid and pemphigus vulgaris
- Oral prednisolone use in people with bullous pemphigoid and pemphigus vulgarisDescription: Technical Summary
Bullous pemphigoid and pemphigus vulgaris are serious autoimmune blistering skin conditions associated with high risk of death and can last for several years. The most common treatment for these diseases is steroid tablets which control the symptoms, but can cause serious side effects including infections and diabetes. Recent research has shown alternative treatment may be effective and safe. Further trials are required but before developing them it is necessary to know the number of eligible patients and what standard care is, in the UK. We will use the CPRD and linked HES to determine the prevalence, incidence, prescription patterns and number of eligible patients to be conducted in future trials on BP and PV. We will use Poisson regression modelling to determine adjusted incidence rate ratios by calendar year, age group, gender, geographical region and socioeconomic group. We will also determine the proportion of misclassification of diagnostic codes to determine the most appropriate codes to use to identify patients with these conditions.
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Infants and ChildrenÂs Primary and Secondary Health Care Costs associated with mode of Childbirth and Gestational Age at Birth — Timothy Coleman ...
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Infants and ChildrenÂs Primary and Secondary Health Care Costs associated with mode of Childbirth and Gestational Age at Birth
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-18
Organisations:
Timothy Coleman - Chief Investigator - University of Nottingham
Laila Tata - Corresponding Applicant - University of Nottingham
Linda Fiaschi - Collaborator - University of Nottingham
Luis Vaz - Collaborator - University of Nottingham
Ravinder Claire - Collaborator - University of Nottingham
Stavros Petrou - Collaborator - University of WarwickOutcomes:
Overall healthcare utilisation
- Mode of delivery
- Prematurity
- NHS reference costsDescription: Technical Summary
Modes of delivery other than spontaneous vaginal delivery (SVD) and being born preterm or early term are hypothesised to be associated with poorer health outcomes in children. It is known that children who have adverse health outcomes also have increased healthcare costs; however, there is currently scant evidence on which areas of healthcare these costs fall and the magnitude and trajectory of these costs. Our objective is to investigate whether mode of birth other than SVD and being born preterm or early term result in greater healthcare costs and, if so, how those additional costs are distributed across different health care services and at different stages of childhood.
We will use Hospital Episode Statistics (HES) linked with Clinical Practice Research Datalink (CPRD) data in the UK in children to investigate whether their mode of delivery and being born preterm or early term are associated with increased healthcare costs, accounting for the effects of their motherÂs health before and during pregnancy, which may have led to a particular mode of birth or early delivery. This will provide data that will comprehensively quantify the economic impact of mode of birth and preterm or early term birth on primary and secondary care services, and should inform future studies on the economic costs of adverse childhood health outcomes in the UK.
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An investigation of the adverse outcomes and resource use associated with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and their relationship with glucocorticoid (GC) treatment — Cormac Sammon ...
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An investigation of the adverse outcomes and resource use associated with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and their relationship with glucocorticoid (GC) treatment
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-19
Organisations:
Cormac Sammon - Chief Investigator - PHMR Associates
Cormac Sammon - Corresponding Applicant - PHMR Associates
Mihail Samnaliev - Collaborator - PHMR Associates
Peter Rutherford - Collaborator - Vifor Pharma
Philip Spearpoint - Collaborator - Vifor PharmaOutcomes:
Infectious outcomes:
- Upper respiratory tract infection
- Lower respiratory tract infection
- Gastrointestinal infection
- Urinary tract infection
- Skin/wound infection
- Liver infection
- Vector Borne illnesses
- Tuberculosis
- Sexually transmitted disease/venereal diseaseBone outcomes:
- Osteoporosis
- Bone fracturesOcular outcomes:
- Cataracts
Metabolic conditions:
- New-onset diabetesMental health outcomes:
- Depression
- AnxietyCardiovascular outcomes
- New-onset hypertension
- Vascular disease
- Stroke/TIA
- Peripheral vascular disease
- Venous thromboembolismRenal outcomes:
- Chronic kidney disease
- End Stage Renal Disease
- DialysisProgressive multifocal leukoencephalopathy
Haemorrhagic cystitis/haematuriaDescription: Technical Summary
AAV is a rare, serious and often life-threatening disease. Morbidities associated with AAV include active vasculitis, infection, cardiovascular disease and malignancy. A number of available treatments are effective in reducing the morbidity and mortality associated with AAV, however these treatments are themselves associated with significant toxicity.
This study will utilise real world data to identify a population of patients in England with AAV and will describe the rate of infectious, bone, cardiovascular, renal, ocular, metabolic and mental health outcomes in the population. Healthcare use in the AAV population will also be described in terms of the rate of GP consultations, GP prescriptions, inpatient visits and outpatient visits.
The study population will subsequently be characterised according to the duration and dose of use of one of the main treatments for AAV, glucocorticoids (GCs), and the rate of the adverse outcomes and healthcare resource use measures described above will be estimated stratified by current and cumulative dose of GC prescribed.
The findings of the study will demonstrate the unmet needs of AAV patients and the potential of emerging 'steroid-sparing' treatments to reduce the treatment related morbidity associated with GC use in AAV.
Source - and 10 more projects — click to show
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Sodium-glucose co-transporter 2 inhibitors and the risk of fractures in patients with type 2 diabetes — Samy Suissa ...
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Sodium-glucose co-transporter 2 inhibitors and the risk of fractures in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-09
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Devin Abrahami - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Fractures
Description: Technical Summary
Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new class of drugs for type 2 diabetes. These drugs work by inhibiting glucose reabsorption in the proximal tubule of the kidneys, increasing urinary glucose output to maintain optimal glycemic levels. While SGLT2 inhibitors are associated with favourable effects, including a low risk of hypoglycemia, there are concerns that these drugs may increase the risk of important adverse events. After reviewing safety data from pre-marketing trials, regulatory agencies expressed concerns that use of SGLT2 inhibitors may increase fracture risk. However, post-marketing trials of SGLT2 inhibitors have produced mixed findings. Although the mechanism supporting an increase in fractures is not entirely understood, it may be explained by elevated serum phosphate levels associated with increased tubular reabsorption, or by a reduction in bone mineral density.
We will assemble a cohort of approximately 80,000 patients newly-treated with antidiabetic drugs between January 1, 2013 and December 31, 2017, with follow-up until March 31, 2018. Current use of SGLT2 inhibitors will be modelled as a time-varying variable. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of fractures associated with use of SGLT2 inhibitors, compared with use of dipeptidyl peptidase-4 inhibitors.
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Association of early detection of non-diabetic hyperglycaemia and clinical outcomes in England: a retrospective cohort study — Christopher Millett ...
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Association of early detection of non-diabetic hyperglycaemia and clinical outcomes in England: a retrospective cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-03
Organisations:
Christopher Millett - Chief Investigator - Imperial College London
Raffaele Palladino - Corresponding Applicant - Imperial College London
Eszter P Vamos - Collaborator - Imperial College London
Kiara Chang - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College LondonOutcomes:
 Diagnosis of Retinopathy
 Diagnosis of Acute Coronary disease
 Cardiovascular risk factors (e.g. BMI, blood pressure)
 Diagnosis of Nephropathy
 Diagnosis of Peripheral Arterial Disease
 Prescription of anti-diabetic medications
 Diagnosis of Cerebrovascular disease
 Cardiovascular disease and all-cause mortalityDescription: Technical Summary
This is a retrospective open cohort study of adults diagnosed with T2D between Jan 2004 and Sept 2017 and registered with CPRD practices in England. The study aims to characterise the detection of non-diabetic hyperglycaemia (NDH) in primary care settings in England. It also aims to assess whether the detection of NDH prior to the diagnosis of T2D reduced the risk of the detection of microvascular and macrovascular complications at diagnosis of T2D, and all-cause and CVD mortality. CPRD data will be linked to ONS and mortality data to improve detection of the outcomes. Individuals will enter the cohort at time of the T2D diagnosis and followed-up until the end of the study period. Inverse probability weighting regression adjustment methods will be employed to model the probability of having a diabetes-related complication present at time of diagnosis or following a diagnosis of T2D as well as to model differences in rates of cardiovascular disease and all-cause mortality. The models will account for the probability of being tested and detected with NDH prior to the diagnosis of T2D (exposure variable) and will be controlled for individual and general practice characteristics associated with testing and disease progression.
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Referral rates of severe asthma patients to asthma specialists in the UK and the impact on healthcare use — Jennifer Quint ...
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Referral rates of severe asthma patients to asthma specialists in the UK and the impact on healthcare use
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation (index other than the most recent)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-09
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
Specialist referral
- Asthma medication use
- Primary care consultations
- Asthma exacerbationsDescription: Technical Summary
We will identify a cohort of asthma patients that should be referred for specialist respiratory management, according to clinical guidelines or Royal College of Physicians recommendations. These will include (1) asthma patients prescribed a high-dose inhaled corticosteroid (labelled as 'severe asthma') or (2) asthma patients prescribed > 2 prescriptions of oral corticosteroids (OCS) in a year.
We will describe how many severe asthma patients, and those with >2 OCS in a year, were referred to a respiratory specialist (using HES out-patient data). We will also describe their healthcare utilisation (HCU); this will include primary care consultations, secondary care clinics, exacerbations (treated in primary and secondary care), and asthma medications (maintenance and reliever medications). We will stratify this data by asthma severity (based on type of asthma medication), gender, age, socioeconomic status, country and clinical commissioning government (CCG) areas. We will look at the trend of all the outcomes over ten years, 2006 to 2017, by their stratification.
After describing the asthma population in this way we will assess if there is an association between being referred to an asthma specialist and the different components of HCU (except secondary clinics). To do this we will use a multivariate Poisson regression model, and stratify by asthma severity. The model will be adjusted for multiple covariates including, gender, age, socioeconomic status, comorbidities and other respiratory diseases.
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The resource use, financial costs and related epidemiology of treating people with HIV and its associated comorbidities vs. matched controls in the UK general population — Christopher Morgan ...
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The resource use, financial costs and related epidemiology of treating people with HIV and its associated comorbidities vs. matched controls in the UK general population
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-19
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
- Corresponding Applicant -
- Collaborator -
- Collaborator -
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Population demographics
- Resource use and financial costs
- Comorbidity prevalence
- Polypharmacy
- Anti-retroviral treatments (where recorded)Description: Technical Summary
Anti-retroviral medicines have evolved over time to the extent that people infected with HIV now survive to full life expectancy. The proposed study is hypothesis generating using a retrospective, cohort design, and intended to provide baseline values to design further studies. Whilst we focus on determining the costs of treating those who are infected with HIV, we will also generate reference values from the general population using matched cases. The primary objective of the study is to characterise the NHS resource use and costs of care of treating people with HIV. Secondarily, epidemiological data will also be characterised in order to understand how these costs are being generated, to examine if/how these have changed over time, and how they compare to the same patterns in the reference cases.
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Impact of EU label changes for systemic diclofenac & hydroxyzine products: post-referral prescribing trends — Thomas MacDonald ...
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Impact of EU label changes for systemic diclofenac & hydroxyzine products: post-referral prescribing trends
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-18
Organisations:
Thomas MacDonald - Chief Investigator - University of Dundee
Rob Flynn - Corresponding Applicant - University of Dundee
Daniel Morales - Collaborator - University of Dundee
Isla Mackenzie - Collaborator - University of Dundee
Li Wei - Collaborator - University College London ( UCL )
Steve Morant - Collaborator - University of DundeeOutcomes:
Time trends in prescribing, switching, discontinuation and initiation rates
Description: Technical Summary
A population-based longitudinal observational study will be conducted using data from the CPRD database to examine trends in the prescribing of these drugs. The study population will consist of all patients registered with the CPRD database during the study period and will be followed up until death, end of follow-up or end of registration. The main outcome being evaluated will be changes in prescribing patterns of diclofenac, hydroxyzine and other related medicines. We will plot trends in the proportions of patients prescribed these drugs over the study period among each clinical patient group of interest. These groups include patients with ischaemic heart disease, heart failure, peripheral arterial disease, stroke and those at high risk of cardiovascular disease (high blood pressure, high cholesterol or diabetes, smokers). Step change and time trends in prescribing will be analysed using interrupted time series regression or jointpoint regression analyses to determine whether statistically significant changes in prescribing were associated with regulatory interventions.
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Identifying patients with familial hypercholesterolemia who could benefit from treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors: Development and validation of a logistic regression predictive model — Martin Frisher ...
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Identifying patients with familial hypercholesterolemia who could benefit from treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors: Development and validation of a logistic regression predictive model
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-23
Organisations:
Martin Frisher - Chief Investigator - Keele University
Myron Odingo - Corresponding Applicant - Keele University
Stephen Chapman - Collaborator - Keele UniversityOutcomes:
Effective treatment of elevated cholesterol
- Non-effective treatment of elevated cholesterolDescription: Technical Summary
The objective of this study is to develop and validate a mathematical model that can predict the therapeutic outcome of familial hypercholesterolemia (FH) patients who are taking the currently recommended treatments.
All patients with a diagnosis of FH and data 'acceptable' for research will be extracted from CPRD; FH is represented by the NHS Read Code "C32" and daughter codes. The sample will be refined to include patients with at least two low density lipoprotein cholesterol (LDLC) test records that are more than a year apart of medication usage. The outcome of the study will be the change in LDLC levels as described by NICE guidelines. The outcome variable will be split into two categories. 11 patient characteristics variables will be used as the independent variables for the study. The total sample will be randomly split into a derivation cohort (75%) for developing the model; and a validation cohort (25%). Chi square tests will be carried out to assess the correlation between the variables. Binary logistic regression using the forward stepwise method will be used to produce the predictive model (p<0.05).
The model accuracy will be assessed by the area under receiver operating curve (AUC) value or Harrell's c-statistic. Model calibration will be carried out by comparing the predicted cases with observed cases in the validation cohort. The predicted probabilities will be stratified by deciles.
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Cardiovascular risk and kidney disease progression in chronic kidney disease — Borislava MIHAYLOVA ...
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Cardiovascular risk and kidney disease progression in chronic kidney disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-09
Organisations:
Borislava MIHAYLOVA - Chief Investigator - University of Oxford
Richard Stevens - Corresponding Applicant - University of Oxford
Benjamin Feakins - Collaborator - University of Oxford
Claire Simons - Collaborator - University of Oxford
Iryna Schlackow - Collaborator - University of Oxford
Jason Oke - Collaborator - University of Oxford
Pengfei Zhu - Collaborator - University of Oxford
Rafael Perera - Collaborator - University of OxfordOutcomes:
Cardiovascular disease
 End stage renal diseaseDescription: Technical Summary
Patients with chronic kidney disease (CKD) are at an increased risk of cardiovascular disease but there are no widely accepted risk scores to evaluate risk in individual patients. The QRISK risk prediction tool is widely used in UK to evaluate 10-year risk of cardiovascular disease (ie, coronary heart disease, ischaemic stroke, or transient ischaemic attack) and guide primary cardiovascular disease prevention, including in people with mild CKD, but its performance in CKD is unknown. Firstly we aim to quantify the risk of progression of CKD, and incident CVD, in people with CKD, stratified by level of CKD (aim 1). Secondly (aim 2) we will validate the QRISK3 score in people with mild-to-advanced CKD (estimated glomerular filtration rate [eGFR]<90 ml/min/1.73m2), and (aims 3 and 4) develop and validate a new cardiovascular risk score (CKD-CVD Risk Score) using a primary prevention CKD cohort, derived from CPRD. The new CKD-CVD Risk Score will be derived separately for women and men. We will use a range of demographic and clinical risk factors including those used in QRISK3 as well as including additional factors, such as eGFR. The HarrellÂs C index and the ratio of predicted-to-observed risks will be used in model validation.
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Improved characterization of the overlap syndrome of heart failure, atrial fibrillation and acute coronary syndromes — Amitava Banerjee ...
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Improved characterization of the overlap syndrome of heart failure, atrial fibrillation and acute coronary syndromes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-27
Organisations:
Amitava Banerjee - Chief Investigator - University College London ( UCL )
Amitava Banerjee - Corresponding Applicant - University College London ( UCL )
Daniel Swerdlow - Collaborator - University College London ( UCL )
Folkert Asselbergs - Collaborator - University College London ( UCL )
Ghazaleh Fatemifar - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Muhammad (Ashkan) Dashtban - Collaborator - University College London ( UCL )
Qianrui Li - Collaborator - Sichuan University
Riyaz Patel - Collaborator - Barts Health and UCLH NHS Trusts
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Suliang Chen - Collaborator - University College London ( UCL )
Tom Lumbers - Collaborator - University College London ( UCL )Outcomes:
Heart Failure
- All-cause mortality
- Cardiovascular disease
- Coronary artery disease
- Cardiovascular mortality
- GP appointments
- Atrial fibrillation
- Stroke
- Hospital admissions
- Thromboembolism
- Emergency department attendances
- Percutaneous coronary interventions
- Coronary artery bypass graft surgeryDescription: Technical Summary
The project intends to work on complex data to better understand how to define phenotypes and discover sub-phenotypes of three most common cardiovascular diseases: heart failure (HF), atrial fibrillation (AF) and acute coronary syndromes (ACS). Unsupervised machine learning approaches such as clustering have been adopted with the intention of recognising disease subtypes. However, those analyses are mostly confined to individual diseases and specific patient sub-groups, which may lead to inaccurate clustering and consequently inaccurate diagnostics. Furthermore, these three heart diseases are frequently risk factors for each other, and sometimes co-exist, which are currently understudied as an Âoverlap syndrome. Therefore, we aim:
1) To use combined unsupervised and supervised statistical learning to improve discoveries of sub-phenotypes of HF and AF.
2) To define a broader, joint phenotype of HF or AF for subphenotype.
3) To cluster longitudinal phenotypes of HF and AF in order to resolve the inter-related phenotypes.
4) To use machine learning (supervised, unsupervised or combined) to identify clusters in the overlap syndromes between HF, AF and ACS, in other words, to characterize what phenotypes there are in clusters where three diseases overlap.
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Towards an accessible methodology in precision medicine: methods for time-to-event data and non-regular inferences with an application to treatment of type 2 diabetes — Samy Suissa ...
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Towards an accessible methodology in precision medicine: methods for time-to-event data and non-regular inferences with an application to treatment of type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-09-27
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Erica Moodie - Collaborator - McGill University
Gabrielle Simoneau - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
Cardiovascular disease
- Myocardial infarction
- Death Cerebral infarction
- Stroke
- Coronary heart disease
- Heart failure
- Death cerebral infarction
- Heart attack
- Subarachnoid hemmorage
- Congestive heart failureDescription: Technical Summary
The objectives of this study are primarily methodological. We aim to develop a novel method to identify a sequence of individualized treatment decisions when the outcome of interest is survival time. Theoretical derivations will be used to formalize the novel method, hereafter referred to as dWSurv, and its performance will be assessed via computer simulations. The analysis of type 2 diabetes treatment pathways will be conducted to showcase the newly developed method while answering an important clinical question: what is the optimal sequence of individualized treatment decisions for maximizing the overall complication-free survival time when metformin initially fails to control the symptoms in patients with type 2 diabetes? The study population consists of all patients who were treated with a first-ever prescription of metformin. The study cohort will be selected from the CPRD data linked with the HES database. The endpoint will be defined from a list of ICD-10 codes characterizing cardiovascular events and death. Specific drug classes will be compared, and possible confounders will be identified. Optimal individualized treatment decisions will be estimated with dWSurv, which require specifying several log-linear and logistic models.
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Retrospective Study into the Journey of Patients with Chronic Cough in the Integrated Health and Social Care System in North West London — Imperial College Healthcare NHS Trust...
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Retrospective Study into the Journey of Patients with Chronic Cough in the Integrated Health and Social Care System in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Sep-18
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Chronic Cough. Commercial
Source
2018 - 08
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Examining treatment patterns of antidepressant and antipsychotic prescriptions; and serious adverse events and the associated economic cost of antipsychotic drug use in people with dementia — Darren Ashcroft ...
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Examining treatment patterns of antidepressant and antipsychotic prescriptions; and serious adverse events and the associated economic cost of antipsychotic drug use in people with dementia
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-06
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Pearl Mok - Corresponding Applicant - University of Manchester
Bruce Guthrie - Collaborator - University of Edinburgh
Georgios Gkountouras - Collaborator - University of Manchester
Jill Stocks - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Rachel Elliott - Collaborator - University of Manchester
Thomas Allen - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of Manchester
Tony Avery - Collaborator - University of NottinghamOutcomes:
Mortality
- Myocardial infarction
- Congestive heart failure
- Stroke or Transient Ischaemic Attack
- Pulmonary embolism or Venous thromboembolism
- Hip fracture
- Serious infection
- Secondary care utilisation
- Cardiac arrhythmia
- Primary care utilisationAdditional outcomes (Feb 2022): acute kidney injury (AKI); combined appendicitis, cholecystitis, and pancreatitis (as controlled outcomes). Please see the Appendix for code lists for these outcomes.
Description: Technical Summary
Our aims are to explore the treatment patterns for medications prescribed for the Behavioural and Psychological Disorders (BPD) associated with dementia and to examine adverse outcomes associated with antipsychotic use (APD). We will delineate a prevalent cohort of patients with a diagnosis of dementia, and examine medication utilisation including APD dose, persistence and switching to alternative treatments, and antidepressant use (ADD). We will also determine factors which influence this use, using regression analysis. From the dementia cohort, we will use stratified cox-proportional hazards models to estimate hazard ratios (HR) for each of the specified outcomes including death, stroke, cardiovascular disease, venous thromboembolism, infection, fracture, and acute kidney injury; for APD use versus non-use. We will additionally use the findings to inform the parameters of an economic model, estimate the costs associated with this outcome in APD use and not use; and map primary and secondary health care utilisation with associated costs, related to this outcome.
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Characterising the renal function of newly diagnosed non-valvular atrial fibrillation patients — Sreeram Ramagopalan ...
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Characterising the renal function of newly diagnosed non-valvular atrial fibrillation patients
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-08
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Cormac Sammon - Corresponding Applicant - PHMR Associates
Elaine Stamp - Collaborator - PHMR AssociatesOutcomes:
Chronic Kidney disease
Description: Technical Summary
Objectives:
To provide evidence to support the development of treatment guidelines in individuals with severe renal dysfunction on diagnosis of non-valvular atrial fibrillation (NVAF).
Methods:
This will be a descriptive population-based cross sectional study in patients with chronic kidney disease (CKD) who are newly diagnosed with NVAF. Patients with an incident AF who already have a CKD diagnosis will be identified from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) for the period of 5 years from 2012 to 2017. Renal function at the time of NVAF diagnosis will be described in terms of creatinine clearance (Cr Cl), Glomerular Filtration Rate (GFR) and the prevalence of end stage renal disease. Prescriptions with relevant OAC drug codes will be identified to classify individuals into drug type categories.
Data analysis:
An analysis stratified by year will use appropriate descriptive statistics to summarise Cr Cl, GFR/eGFR and ESRD. These will be categorised to reflect kidney function and number and proportion in each drug category will be described.
A sensitivity analysis will explore extending time frames for determining GFR and serum creatinine records and weight records.
Data set(s) to be used:
- CPRD GOLD
- HES Admitted Patient Care
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Assessing the effect of switching from an inhaler regimen containing inhaled corticosteroid to one without in a real-world COPD population — Jennifer Quint ...
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Assessing the effect of switching from an inhaler regimen containing inhaled corticosteroid to one without in a real-world COPD population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-06
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Omar Usmani - Collaborator - Imperial College LondonOutcomes:
Inhaler use and inhaler switching by drug class
 Reliever inhaler usage
 Exacerbation rates
 Hospitalised pneumonia ratesDescription: Technical Summary
We will identify a cohort of COPD patients and carry out two study designs, a cohort study and a self-controlled case series (SCCS). In the cohort, the main exposure will be their combined-inhaler regimen (ICS/LABA, LAMA/LABA or triple therapy); categorised also by incident (new COPD diagnosis or switched to a new regimen) or prevalent regimen use. The main outcome will be exacerbations (in primary care, CPRD, and secondary care, HES, or death, ONS). To estimate the effect estimates we will use a Poisson regression model, confounding will be adjusted for using conventional methods and propensity score methodology. As certain unmeasured patients-factors may still influence why a patient was chosen for a particular regimen, we will also carry out a SCCC; this analysis implicitly controls for any time non-varying confounding as the patient acts as its own control. The stable period will be the time before the new regimen; the risk period will follow the new regimen. An incidence rate comparing the stable and risk periods will be estimated using a conditional Poisson model. Time-varying confounder, age, will be controlled for in the regression model. All potential effect modifiers will be investigated by stratified analysis, including disease severity, and eosinophil count.
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Assessing the Burden of Allergy Management in England — Mireia Raluy Callado ...
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Assessing the Burden of Allergy Management in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-21
Organisations:
Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
- Collaborator -
Carmina Alvaro - Collaborator - Sanofi UK
Catherine Brun-Strang - Collaborator - SANOFI
Jason Simeone - Collaborator - Evidera, Inc
Nicola Sawalhi-Leckenby - Collaborator - Evidera, Inc
Roberto Labella - Collaborator - SANOFIOutcomes:
Allergy medication utilisation
- Demographic characteristics
- Concomitant medications
- Death
- Healthcare resource utilisationDescription: Technical Summary
Seasonal and perennial allergies caused by pollen, dust, mould, or pet dander are one of the most common ailments in Europe, and are associated with a reduced quality of life, as well as a substantial burden to healthcare systems. Many treatments are currently available by prescription (Rx) only, therefore requiring a general practitioner (GP) visit. It is possible that switching the status of medications from Rx to over-the-counter (OTC), if appropriate, may result in greater convenience for patients and time-savings for patients and healthcare providers, freeing up healthcare resources for use in managing more complex conditions. However, the current burden of seasonal and perennial allergies in England is unknown.
This retrospective cohort study will identify and characterize patients with seasonal and perennial allergies, quantify the number of allergy-related visits and treatments prescribed, and estimate the associated healthcare resource utilisation (HRU) and costs from 2012-2016. Patients with allergies will be matched to a cohort of patients without a diagnosis or treatment for allergies by age, gender, and GP practice area, and characteristics and HRU/cost measures will be compared across cohorts using descriptive statistics. Costs will be estimated using local unit costs from published resources and adjusted for inflation.
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Is polypharmacy associated with death or ischemic stroke in individuals newly diagnosed with atrial fibrillation? A prognostic cohort study using data from The Clinical Practice Research Datalink (CPRD) — Martin Frisher ...
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Is polypharmacy associated with death or ischemic stroke in individuals newly diagnosed with atrial fibrillation? A prognostic cohort study using data from The Clinical Practice Research Datalink (CPRD)
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-08
Organisations:
Martin Frisher - Chief Investigator - Keele University
Natasha Slater - Corresponding Applicant - Keele University
Simon White - Collaborator - Keele UniversityOutcomes:
Incidence of death during follow up period
 Incidence of ischemic stroke during follow up periodDescription: Technical Summary
This prognostic cohort study has been designed to determine whether polypharmacy is associated with death or ischemic stroke among individuals who have been newly diagnosed with atrial fibrillation. Only data labelled as Âacceptable by CPRD will be used in this study. All patients with a recorded diagnosis of AF will be identified. The earliest record of AF will be defined as the index date. Details of prescribed medications, issued within the first three months of the index date, will be obtained for each patient. Using this data, patients will be allocated into one of the following three groups: unexposed at study entry (1-4 different prescribed medicines), exposed to polypharmacy at study entry (5-9 different prescribed medicines) or exposed to hyper-polypharmacy at study entry (?10 different prescribed medicines). Patients will be followed until the occurrence of a study outcome (i.e. death or ischemic stroke) or until the end of follow-up (10 years maximum). Comparisons will be made between the incidence of death and ischemic stroke in the exposed, compared to the unexposed groups. All models will be adjusted for known prognostic factors, which will be measured in the two years prior to index date.
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The relationship between partner bereavement and being diagnosed with dementia — Harriet Forbes ...
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The relationship between partner bereavement and being diagnosed with dementia
Datasets:GP data, HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-28
Organisations:
Harriet Forbes - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Morton - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Marcus Richards - Collaborator - University College London ( UCL )
Sigrun Alba Johannesdottir Schmidt - Collaborator - Aarhus University Hospital
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Diagnosed dementia
Description: Technical Summary
Given the rapid growth of the ageing population and the anticipated increase in dementia cases globally, identifying those who are at high-risk of the condition may be useful to help target preventive dementia strategies. Partner bereavement has been associated with an increased risk of dementia; however, this association has not been well-described using UK-based data. This study will build on the existing evidence base to better understand to what extent partner bereavement affects the development, and diagnosis of, dementia and what are the main factors mediating the association. We will use a matched cohort study to examine if partner bereavement is associated with the onset of diagnosed dementia among heterosexual couples. Partners will be defined as two persons with (1) the same family number, (2) opposite sex, (3) an age gap of </= 10 years and (4) no younger adult in the household within 15 years of either of the couple. We will then identify all deaths occurring in the couples during 1997-2018 and the bereaved partner will be classified as exposed. The date of partner bereavement will be considered the index date. Next, we will randomly match each exposed person by age and sex to a non-exposed person. Persons in the matched cohort have to be alive and have a partner but without ever-experiencing previous partner bereavement on the index date for the matched exposed person. Using stratified Cox regression, we will compute hazard ratios with 95% confidence intervals for the association between partner bereavement and dementia. We will examine if associations vary by characteristics of the bereaved, such as gender and age.
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Investigating associations between environmental factors and exacerbations of COPD and asthma — Jennifer Quint ...
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Investigating associations between environmental factors and exacerbations of COPD and asthma
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Non-standard
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Ana Maria Vicedo-Cabrera - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Antonio Gasparrini - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Francesco Sera - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
COPD exacerbations
 Asthma exacerbationsDescription: Technical Summary
Changes in temperature, humidity and air pollution are related to exacerbations for chronic obstructive pulmonary disease (COPD) and asthma. However, these health associations are not well characterised due, in part, to insufficiently detailed environmental exposure estimates in studies, and in part to the difficulty in estimating complex temporal patterns of risks involving exposures varying in time and multiple exacerbations events. This study will use linked patient data via General Practices contributing to CPRD, and relevant daily atmospheric data held by DEFRA and BADC monitoring stations as the best available proxy for environmental data in the locality of a given practice. The analysis will be performed by applying the case time series design, a novel analytical method to investigate transient effects of time-varying factors in a longitudinal setting. This is a novel approach that combines design features from time series analysis with individual-level case-only methods, and allow the assessment of complex temporal effects of exposures with multiple health events while controlling by design for time-invariant confounders. Findings from this study will be of benefit to both patients and health care providers by helping to improve the organisation of health care resources, particularly in the winter and highlight times when patients should be aware of increased risk of exacerbations.
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Do systemic antibiotics affect the effectiveness of chemotherapy for malignant cancers? - A cohort study based on CPRD and Cancer Registry data — Tjeerd van Staa ...
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Do systemic antibiotics affect the effectiveness of chemotherapy for malignant cancers? - A cohort study based on CPRD and Cancer Registry data
Datasets:GP data, How does recent antibiotic exposure impact chemotherapy treatment and associated mortality of patients with a new diagnosis of cancer
- Drug effectiveness
- Cancer incidenceProcessing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-13
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Victoria Palin - Corresponding Applicant - University of Manchester
Andrew G Renehan - Collaborator - The Christie NHS Foundation Trust
Darren Ashcroft - Collaborator - University of Manchester
Eleni Domzaridou - Collaborator - University of Manchester
Taher Hamid - Collaborator - University of ManchesterOutcomes:
How does recent antibiotic exposure impact chemotherapy treatment and associated mortality of patients with a new diagnosis of cancer
- Drug effectiveness
- Cancer incidenceDescription: Technical Summary
We propose to conduct a cohort study. The cohort will consist of patients with an incident diagnosis of different types of cancer who have been exposed to oral and/or intravenous antibiotics prior to the index date of the cancer diagnosis. The rate of mortality after the cancer diagnosis will be compared between recent and past antibiotic users. Cancer patients with specific comorbidities for which there is evidence that they can act as potential confounders will be excluded based on READ codes. Data linkages between CPRD, Office of National Statistics (ONS) Mortality data and Cancer Registry data will be used. The analysis will be based on Kaplan-Meier plots and Cox regression modelling, estimating how survival is affected by past antibiotics exposure (and indirectly microbiota) before cancer onset.
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Testosterone replacement therapy and the risk of prostate cancer in men with age-related hypogonadism — Samy Suissa ...
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Testosterone replacement therapy and the risk of prostate cancer in men with age-related hypogonadism
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-21
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Christel Renoux - Collaborator - McGill University
Christina Santella - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Incidence of prostate cancer in patients with age-related hypogonadism
Description: Technical Summary
There is conflicting evidence regarding the association between the use of testosterone replacement therapy (TRT) and the incidence of prostate cancer. Indeed, some observational studies suggest an association, while others demonstrate safety with regards to the prostate. However, these studies had important limitations, complicating the interpretation of their findings. Given the prevalence of testosterone deficiency and the increasing use of TRT, further studies are needed to evaluate this association. Thus, this study will investigate the association between TRT and prostate cancer by assembling a cohort of 15,000 men newly-diagnosed with age-related hypogonadism between 1 January 1995 and 31 August 2016, and followed until 31 August 2017. Time-dependent Cox proportional hazards models will be used to estimate adjusted hazard ratios with 95% confidence intervals of prostate cancer associated with the use of TRT, compared with non-use. Secondary analyses will assess whether the association varies with cumulative duration of use, time since initiation, and TRT type (e.g., injection, patch, gel, pill, buccal tablet). In addition, several sensitivity analyses will be conducted to assess the robustness of the findings.
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Relationship between Body Mass Index (BMI) trajectory and the risk of cardiovascular disease and diabetes among overweight and obese people: A UK Primary Care-based cohort study — Barbara Iyen ...
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Relationship between Body Mass Index (BMI) trajectory and the risk of cardiovascular disease and diabetes among overweight and obese people: A UK Primary Care-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-06
Organisations:
Barbara Iyen - Chief Investigator - University of Nottingham
Barbara Iyen - Corresponding Applicant - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
Primary outcome
- Incidence of cardiovascular disease associated with variation in BMI over time, among individuals who are overweight or obese
Secondary outcome
- Incidence of Type 2 diabetes associated with variation in BMI over time, among individuals who are overweight or obeseDescription: Technical Summary
Background: Existing evidence indicate changes in weight lead to changes in the risk factors for cardiovascular disease (CVD) and type-2-diabetes mellitus (T2DM). However, there is insufficient knowledge of the effects of body mass index (BMI) changes on the overall risk of CVD and T2DM in overweight/obese patients.
Objectives:
1. To identify BMI change patterns over time in obese and overweight individuals
2. To determine the relationship between distinct BMI trajectories and CVD and T2DM outcomes
Study design: Cohort designSetting: UK General Practice
Participants: Adult patients free from CVD or T2DM at baseline, registered for at least one year before the study start date, with a baseline BMI of 25kg/m2 or greater and minimum of 3 BMI readings during the study period.
Outcome: Incident CVD and T2DM diagnosis
Methods: For each patient, 4 measurements of BMI over a 10 year period will be collected (at baseline, 2, 5 and 10 years). Using latent class analysis, distinct BMI trajectory groups will be identified and the relationship between BMI trajectories with CVD and T2DM assessed.
Outputs: Distinct BMI trajectories for overweight and obese patients. Significance and effect of the association between BMI trajectories and CVD as well as T2DM.
Source - and 12 more projects — click to show
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Age at onset of multiple cardiovascular disease conditions: differences in ethnic subgroups by diabetes status — Francesco Zaccardi ...
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Age at onset of multiple cardiovascular disease conditions: differences in ethnic subgroups by diabetes status
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-28
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Briana Coles - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Suping Ling - Collaborator - University of Leicester
Yogini Chudasama - Collaborator - Leicester Diabetes CentreOutcomes:
Incidence of multiple cardiovascular disease conditions: myocardial infarction, coronary death, stable angina, unstable angina, heart failure, transient ischaemic attack, ischaemic stroke, subarachnoid haemorrhage, intracerebral haemorrhage, peripheral arterial disease, abdominal aortic aneurysm, PTCA, or coronary artery bypass grafting
- Years of life lost after the onset of any of the above condition, by diabetes and ethnicity statusDescription: Technical Summary
Using data collected in the CPRD Gold Database with linkage to HES admitted patient care and ONS death registry, the primary aim of the study is to assess the age at onset of several cardiovascular disease conditions (including myocardial infarction, coronary death, heart failure, transient ischaemic attack, ischaemic stroke, peripheral arterial disease) and survival differences (i.e., prognosis) for these multiple cardiovascular disease conditions following the diagnosis, compared by diabetes status and ethnicity. In particular, this study will include a retrospective cohort of patients aged 18 years or over, with or without a diagnosis of type 2 diabetes mellitus (T2DM) at study entry. A survival analysis will be applied to assess whether diabetes status and ethnicity influence the age at onset of the cardiovascular diseases and the survival following the cardiovascular disease event. Self-reported ethnicity is obtained from HES and CPRD data, and categorized as White, South Asian (including Indian, Pakistani, and Bangladeshi, and mixed Asian), Black (including Caribbean, African, and mixed Black), or other.
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Fractures in people with intellectual disabilities: comparison with the general population and development of a fracture risk calculator specific to these patients — Valeria Frighi ...
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Fractures in people with intellectual disabilities: comparison with the general population and development of a fracture risk calculator specific to these patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-07
Organisations:
Valeria Frighi - Chief Investigator - University of Oxford
Valeria Frighi - Corresponding Applicant - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Gary Collins - Collaborator - University of Oxford
Jan Roast - Collaborator - Oxfordshire Family Support Network
Lei Clifton - Collaborator - University of Oxford
Tim Holt - Collaborator - University of Oxford
Timothy Andrews - Collaborator - Oxford Health NHS Foundation TrustOutcomes:
Incidence of fracture in the UK population with intellectual disabilities
- Incidence of fracture in the general UK population
- Risk factors determining risk of fracture in people with intellectual disabilities and their relative contributions to fracture riskDescription: Technical Summary
Despite evidence from other countries of increased fracture risk in patients with intellectual disabilities (ID), UK based epidemiological data is lacking and the risk factors for fractures in these patients are not clearly established.
In a Fracture Incidence Study, we will compare the rates of a) all fractures, b) fragility fractures and c) hip fractures between patients with ID and general population subjects in the Clinical Practice Research Datalink (CPRD).In a Fracture Risk Assessment Study, we'll investigate all the predictors included in the most recent available version of Qfracture, a fracture risk calculator for the general population recommended by the National Institute of Health and Care Excellence, and additional potential risk factors more specific to ID patients. These will include cause of ID (e.g. Down's syndrome), associated illnesses (e.g. cerebral palsy), medication (e.g. antipsychotics), and others. We will construct and validate a fracture risk assessment tool using a derivation cohort and a validation cohort within the CPRD. Two thirds of the CPRD practices will be randomly assigned to the derivation dataset, on which we will construct the model using Cox regression analysis, and one third to the validation dataset, by which we will evaluate its predictive accuracy.
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General practice consulting behaviours prior to atrial fibrillation diagnosis: an investigation of potential opportunities for targeted screening — Sreeram Ramagopalan ...
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General practice consulting behaviours prior to atrial fibrillation diagnosis: an investigation of potential opportunities for targeted screening
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-28
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Cormac Sammon - Corresponding Applicant - PHMR Associates
Elaine Stamp - Collaborator - PHMR Associates
Megan Besford - Collaborator - PHMR Associates
Tzu-Chun Kuo - Collaborator - PHMR AssociatesOutcomes:
 Influenza vaccination
 Congestive heart failure
 Coronary artery disease
 Peripheral artery disease
 DiabetesDescription: Technical Summary
Objectives
To investigate whether the prevalence of certain consultations are increased in the 3-year period prior to an AF diagnosis relative to the prevalence in a matched AF-free control group.Methods
The study will use a matched case control design in which a group of individuals with AF will be identified and matched to a set of controls without AF based on age, sex and practice. The prevalence of consultations for influenza vaccinations, congestive heart failure, coronary artery disease, peripheral artery disease and diabetes in the 3 year period prior to the index date will be described for cases and for controls and conditional logistic regression will be used to estimate odds ratios and 95% confidence intervals describing the relationship between the prevalence in cases and controls. Subgroup analyses will stratify the AF cases into early and late diagnoses (based on whether a thromboembolic event led to the identification of AF).As an exploratory analysis an additional set of consultation types will be identified based on their prevalence in the cases and a selection of the analysis will be repeated for a selection of the identified consultations.
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Evaluation of natural history and health care resource utilisation of patients with monocloncal gammopathy of unknown significance and myeloma bone disease — Kassim Javaid ...
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Evaluation of natural history and health care resource utilisation of patients with monocloncal gammopathy of unknown significance and myeloma bone disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-23
Organisations:
Kassim Javaid - Chief Investigator - University of Oxford
Kassim Javaid - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Constantinos Koshiaris - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Mital Kinderkhedia - Collaborator - University of Oxford
Rafael Pinedo-Villanueva - Collaborator - University of Oxford
Samuel Hawley - Collaborator - University of BristolOutcomes:
Primary outcomes:
- Bone fracture
Secondary outcomes:
- Prevalence
- Natural history
- Complications
- Progression of MGUS to myeloma
- Health care use and costsDescription: Technical Summary
Myeloma is a rare cancer of the bone marrow. While the clinical focus is on treating myeloma, bone complications are a major concern to patients. Myeloma is always preceded by a premalignant condition called monoclonal gammopathy of unknown significance (MGUS), diagnosed by measuring special proteins called paraproteins in the blood and urine. Having MGUS is also associated with an increased risk of bone complications1 as well as progression to myeloma.
The aim of this study is to provide evidence to inform the clinical decision-making and provision of health care services to reduce the burden of bone complications in MGUS and myeloma2.
We will use the Clinical Practice Research Datalink verification study where the GPs General Practitioners of potential patients are sent a brief anonymous questionnaire to validate the patients specific diagnoses. Regression methods, including generalised linear models, will be used to describe the other diagnoses/ procedures to understand the natural history, health care usage and costs for people with MGUS and myeloma and their determinants using CPRD and where available linkage to HES. We will compare these findings with up to 4 controls of the same age, gender, ethnicity and GP practice.
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Developing and validating a measure of inappropriate polypharmacy — Rupert Payne ...
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Developing and validating a measure of inappropriate polypharmacy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-27
Organisations:
Rupert Payne - Chief Investigator - University of Bristol
Rupert Payne - Corresponding Applicant - University of Bristol
Peter Tammes - Collaborator - University of Bristol
Richard Morris - Collaborator - University of BristolOutcomes:
Inappropriate polypharmacy
 Primary care consultation rate
 Adverse drug reaction
 DeathDescription: Technical Summary
Medicines are a major therapeutic intervention available to clinicians. We have an ageing, increasingly multimorbid population, driving the phenomenon of polypharmacy (multiple drug use in an individual). Although sometimes clinically justified, polypharmacy can also be inappropriate, leading to undesirable outcomes (e.g. prescribing errors, impaired quality of life, adverse effects). There is no accepted means of quantifying inappropriate polypharmacy. The aim of this project is to develop a valid, reliable measure of inappropriate polypharmacy for use in clinical practice.
We have previously conducted an expert consensus process to identify key aspects of prescribing considered relevant to inappropriate polypharmacy, focusing on generic aspects of prescribing. We will operationalise those aspects that are readily quantified using routine health data, to develop an Inappropriate Polypharmacy Score (IPS). The concurrent validity of the IPS will be established by comparing it against expert ratings of 600 polypharmacy cases randomly drawn from CPRD representing a range of polypharmacy. An epidemiological analysis will then be conducted in 300,000 patients to examine the clinical and sociodemographic factors associated with the IPS, association between IPS and relevant adverse outcomes including adverse reactions, errors and health service use (predictive validity), and practice-level reliability.
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Comparative Safety of the Sodium Glucose Co-transporter-2 (SGLT2) Inhibitors in Patients with Type 2 Diabetes — JM Gamble ...
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Comparative Safety of the Sodium Glucose Co-transporter-2 (SGLT2) Inhibitors in Patients with Type 2 Diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-19
Organisations:
JM Gamble - Chief Investigator - University Of Waterloo
JM Gamble - Corresponding Applicant - University Of Waterloo
Arsene Zongo - Collaborator - University of Alberta
Baiju Shah - Collaborator - University of Toronto
Dean Eurich - Collaborator - University of Alberta
Wasem Alsabbagh - Collaborator - University Of WaterlooOutcomes:
Acute Kidney Injury
- Composite of new or worsening nephropathy
- Fragility fractures
- Composite of lower limb amputations
- Ketoacidosis
- Composite of urinary tract infection
- Composite of genital infections
- Composite of all-cause mortality and all-cause hospitalizationsDescription: Technical Summary
Objective: To measure the association between use of the sodium glucose co-transporter (SGLT2) inhibitors for the management of type 2 diabetes and safety outcomes.
Methods: We propose to conduct a series of population-based cohort studies using information from everyday health system encounters. We will quantify the risk of several important safety outcomes among metformin monotherapy initiators who subsequently start a second agent. Within each database, separate cohorts of propensity score matched new users of SGLT2 inhibitors and new users of dipeptidyl peptidase-4 inhibitors will be formed. We will then compare the adjusted population-based rates of: 1) acute kidney injury, 2) composite of new or worsening nephropathy, 3) fragility fractures, 4) composite of lower limb amputations, 5) ketoacidosis, 6) composite of urinary tract infections, 7) composite of genital infections, 8) composite of all-cause mortality and all-cause hospitalizations.
Data analysis: We will use proportional hazards regression models with fixed and time-dependent variables to precisely define both drug exposures and confounders, and to determine if SGLT2 inhibitors are independently associated with a change in risk in these safety outcomes. Analyses will be conducted separately in multiple databases and then each estimate will be combined using random-effects meta-analysis.
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M.A.P.P.E.D. IMproving the Accuracy of Psychosis PrEDiction using primary-care consultation data — Sarah Sullivan ...
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M.A.P.P.E.D. IMproving the Accuracy of Psychosis PrEDiction using primary-care consultation data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-06
Organisations:
Sarah Sullivan - Chief Investigator - University of Bristol
Sarah Sullivan - Corresponding Applicant - University of Bristol
Daphne Kounali - Collaborator - University of Bristol
David Kessler - Collaborator - University of Bristol
Glyn Lewis - Collaborator - University College London ( UCL )
Irwin Nazareth - Collaborator - University College London ( UCL )
James Robinson - Collaborator - Avon and Wiltshire Mental Health Partnership NHS Trust
Richard Morris - Collaborator - University of Bristol
William Hamilton - Collaborator - University of ExeterOutcomes:
Primary outcome-a coded diagnosis of a psychotic disorder
Description: Technical Summary
People with psychosis, including schizophrenia, frequently have poor outcomes. Approximately 25% relapse within 36 months and many suffer residual symptoms. Quality of life is often low. Repeated relapses are associated with increased distress and greater cognitive impairment. The costs of treating psychosis are high and increased by poor outcomes.
Many risk factors for a poorer outcome are difficult or impossible to modify. Increasingly research has focussed on duration of untreated psychosis (DUP) because it is negatively associated with outcome and potentially modifiable.
Most sufferers enter specialist services via primary-care, therefore it is important for GPs to recognise emerging psychosis. However, many GPs find this difficult because the early symptoms of psychosis are non-specific. Our data shows that this group presents more frequently to primary-care in the prodromal phase, particularly in the final 6 months, representing an opportunity for earlier diagnosis. There is a need for a primary-care predictive tool. We have already defined candidate predictors. The next stage is to develop and validate a prediction model.
An effective prediction tool could expedite referral, decrease DUP, improve outcomes and reduce pressure on primary-care and A&E. A tool with greater specificity and sensitivity may lead to more efficient resource allocation resources.
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Variation in patient pathways and hospital admissions for exacerbations of COPD: linking the National Asthma and COPD Audit Programme (NACAP) with CPRD data — Jennifer Quint ...
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Variation in patient pathways and hospital admissions for exacerbations of COPD: linking the National Asthma and COPD Audit Programme (NACAP) with CPRD data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-13
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Philip Stone - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Johanna Feary - Collaborator - Imperial College London
Mike Roberts - Collaborator - Royal College Of Physicians - RCP
Noel Baxter - Collaborator - Royal College Of Physicians - RCP
Puja Myles - Collaborator - CPRD
Rebecca Ghosh - Collaborator - CPRD
Viktoria McMillan - Collaborator - Royal College Of Physicians - RCPOutcomes:
Inappropriate hospital admission
- Avoidable hospital admission
- Best practice care of acute exacerbation of COPD post-discharge
- Readmission in the 30 days after discharge
- Death in the 30 days after discharge
- The 2017 National COPD Audit queriesDescription: Technical Summary
The National Asthma and Chronic Obstructive Pulmonary Disease (COPD) Audit Programme (NACAP) provides data on the care received by COPD patients in the United Kingdom (UK). Most COPD patients experience episodes of worsening in respiratory symptoms, termed acute exacerbations (AECOPD). AECOPD is one of the most common reasons for adult emergency hospital admission in the UK, resulting in significant healthcare usage and cost. The secondary care clinical arm of NACAP (NACAP-SC) contains detailed information on clinical features of AECOPD hospital admissions. The aim of this study will be to use routinely linked primary care data, Hospital Episode Statistics (HES), and ONS Death registration data from CPRD and bespoke linked secondary care data for AECOPD taken from NACAP-SC. Using logistic regression, this linked dataset will be used to explore the proportion of potentially avoidable admissions: whether contact with primary care in the 2 weeks prior to an AECOPD reduces the risk of an admission being severe; whether different regions of England have different numbers of inappropriate AECOPD admissions; whether receiving a discharge bundle (a completed checklist of best-practice actions to undertake at discharge) increases the odds of receiving best practice care post-discharge, or reduces the odds of 30-day readmission and death; and whether being seen within 24 hours of admission by the respiratory team increases the odds of receiving best-practice care post-discharge, or reduces 30-day mortality.
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A study to evaluate growth characteristics and burden of illness in patients with achondroplasia — Sarah Landis ...
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A study to evaluate growth characteristics and burden of illness in patients with achondroplasia
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-28
Organisations:
Sarah Landis - Chief Investigator - BioMarin Pharmaceutical Inc.
Sarah Landis - Corresponding Applicant - BioMarin Pharmaceutical Inc.
Alice Huntsman Labed - Collaborator - BioMarin Europe Ltd (closed)
James Jarrett - Collaborator - BioMarin Europe Ltd (closed)
Jeanne Pimenta - Collaborator - BioMarin Pharmaceutical Inc.
Louise Mazzeo - Collaborator - BioMarin Europe Ltd (closed)
Melita Irving - Collaborator - Guy's & St Thomas' NHS Foundation Trust
Richard Baxter - Collaborator - Whippletree ResearchOutcomes:
Primary:
- Standing height
- Sitting height
- Date of height measurement
- Age at the time of height measurement
- Gender of each subject
- HCP Referrals
- Health Care Resource use
- Co-morbidities
- Procedures and surgical interventionsSecondary:
- Complications of procedures and surgical interventions
- Pharmacological treatments received including investigational compoundsDescription: Technical Summary
The objectives of the study is:
- To describe the height-for-age growth in patients with achondroplasia
- To understand the burden of illness for patients with achondroplasia
To help achieve this overall objective, the CPRD data will be used:
- To understand the resource use for patients with achondroplasia over time
- To understand the cost of care for patients with achondroplasia over time
To accomplish these objectives, the investigators will utilise CPRD data to develop height-for-age growth curves by gender, to quantify the number and type of hospital visit (e.g. outpatient visits/inpatient stays), and general practice visits, as well as information on the type and frequency of operations and tests/diagnostics. Basic descriptive statistics will be run to determine the frequency of each outcome. This information will be run for the entire cohort as well as broken down by age, if feasible, to enable investigation into changing needs over time. Where possible, the information from the data sets will be linked to NHS costs using official tariffs/unit costs (e.g. NHS Reference costs or PSSRU unit costs for social care). This data will be aggregated to provide an average cost of care, as well as an investigation into changes in cost over time.
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The burden of incontinence of urine associated with prostate cancer treatment: documenting the prevalence and highlighting the difference between prostate cancer treatment modalities — Ismail Omar ...
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The burden of incontinence of urine associated with prostate cancer treatment: documenting the prevalence and highlighting the difference between prostate cancer treatment modalities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-28
Organisations:
Ismail Omar - Chief Investigator - Imperial College London
Ismail Omar - Corresponding Applicant - Imperial College London
Erik Mayer - Collaborator - Imperial College London
Joshua Symons - Collaborator - NHS Digital ( HSCIC )Outcomes:
Proportion of male incontinence of urine (IU) in the UK and England
- Determine the rate of IU with each modality of treatment of PCa
- Proportion of Prostate cancer (PCa) related male IU in England
- The financial burden of IU resulting from treatment of PCaDescription: Technical Summary
The aim of this study is to determine the proportion of incontinence of urine (IU) in the general male population of UK and document the prevalence of this complication following treatment of prostate cancer (PCa) in a representative English population. This will provide support for decision making in treating PCa and will be a reference for further related incontinence studies. We will start by identifying the prevalence of IU in the male population. The next step will be identifying patients with PCa who developed IU resulting from either PCa diagnosis without treatment or as a complication of their treatment. The prevalence of IU associated with treatment of PCa in England will be calculated and compared to prevalence of IU in England. Descriptive statistical analysis will be used to document the frequency, whereas different modalities of treatments for IU will be compared using One-way ANOVA test to documents the rates variability. The study will also estimate the cost of the development of IU following PCa treatment to determine the financial impact on the health care system.
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Prediction of anticoagulation control and associated health economic outcomes in patients with atrial fibrillation (AF) managed on warfarin — Jason Gordon ...
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Prediction of anticoagulation control and associated health economic outcomes in patients with atrial fibrillation (AF) managed on warfarin
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-21
Organisations:
Jason Gordon - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Jason Gordon - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Ameet Bakhai - Collaborator - Royal Free London NHS Foundation Trust
David Clifton - Collaborator - University of Oxford
Francisca Vargas Lopes - Collaborator - Pfizer Ltd - UK
Nathan Hill - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Phil McEwan - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Steven Lister - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )Outcomes:
The primary health outcomes to be measured in this research protocol are:
- Percentage of time spent in the therapeutic range (TTR)
- Any of: two INR values greater than 5 or one INR value greater than 8 within a six-month period; and/or two INR values less than 1.5 within a six-month period; and/or TTR less than 65%
- <70% TTR
- Percentage of time spent under therapeutic range (TUR) - >/= 30% TUR
- Percentage of time spent over therapeutic range (TOR) - >/= 30% TORThe secondary health outcomes to be measured in this research protocol are:
- Stroke
- All-cause mortality (defined using linked ONS mortality data)
- Stroke
- Transient ischaemic attack (TIA)
- Myocardial infarction
- Deep vein thrombosis
- Pulmonary embolism
- Bleeding event: intracranial, intra-articular, intracerebral, pericardial, gastrointestinal, intraocular, urinary, lung, other
- Bleeding event: intracranial, intra-articular, intracerebral, pericardial, gastrointestinal, intraocular, urinary, lung, other
- Hospitalisation: all admissions, and stratified by diagnosis for the above conditions where possible
- Length-of-stay: all admissions, and stratified by diagnosis for the above conditions where possible
- Healthcare resource costs associated with hospitalisationsDescription: Technical Summary
The effectiveness of warfarin as an anticoagulant is dependent on patients remaining within a narrow therapeutic range based on the International Normalised Ratio (INR). Patients receiving warfarin who are observed to not be stable within this range, or with high or low measurements, may require better management or switching to an alternative oral anticoagulant (OAC). However, outcomes could be improved if such instability could be accurately predicted at the time of anticoagulation initiation, before the patient receives warfarin.
The aim of this retrospective observational study is to evaluate empirical models that can be used in clinical practice for the prediction of anticoagulation control prior to warfarin initiation following AF. Using CPRD and linked HES data, various definitions of anticoagulation control will be explored, and the predictive performance of classical statistical models will be compared to that of machine learning techniques utilising baseline and time-varying covariates. Exploratory analyses will be used to explore clustering and temporal patterns in variables identified as risk factors for poor anticoagulation control. This study also aims to quantify the clinical and economic burden associated with poor anticoagulation control (incidence rates of all-cause mortality, clinical events and hospitalisations), using appropriate statistical techniques to adjust for observed confounders.
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An assessment of CPRD Aurum data quality — Susan Jick ...
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An assessment of CPRD Aurum data quality
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-08-08
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Eleanor Yelland - Collaborator - CPRD
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Puja Myles - Collaborator - CPRD
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Tim Williams - Collaborator - CPRDOutcomes:
Type II diabetes
- Breast cancer
- Pulmonary embolism
- Benign prostatic hyperplasia
- Myocardial infarction
- Rheumatoid arthritis
- Breast cancer and all cancersDescription: Technical Summary
We will use several data quality assessment techniques to assess the quality and completeness of the CPRD Aurum data. We propose a number of exercises based on published recommendations to assess the quality of the newly available CPRD Aurum data including:
 Comparison with a gold standard, comparing hospitalisation-related data in CPRD Aurum to linked HES Admitted Patient Care records.
 data element agreement and validity check methods involving several drug /lab value and drug /disease pairings to look for consistency
 data source agreement method: to assess completeness, correctness, concordance, and plausibility of breast cancer diagnoses in the CPRD Aurum data by comparisons with previously published findings from CPRD GOLD.
 element presence (to understand availability and potential bias of key covariates): We will calculate the number of body mass index (BMI), smoking, blood pressure (BP) records per patient by practice and restricted to patients with cardiovascular disease (CVD) in each practice (a subset of patients who should have more recordings of each of these variables). We will provide the mean, median and mode for each indicator for all patients in a practice vs people with CVD.
We will also look at the proportion of patients who receive drug treatments for benign prostatic hypertrophy (BPH) and have an indication for the drug in their record to assess presence in the GP record.
 data consistency over time: Total number of prescriptions and diagnoses by practice, by month or quarter
Source
2018 - 07
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Drug utilisation among primary care patients with knee osteoarthritis (KOA): a population-based study using CPRD — Roger Knaggs ...
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Drug utilisation among primary care patients with knee osteoarthritis (KOA): a population-based study using CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-11
Organisations:
Roger Knaggs - Chief Investigator - University of Nottingham
Aqila Taqi - Corresponding Applicant - University of Nottingham
Harmony Otete - Collaborator - University Of Central Lancashire
Sonia Gran - Collaborator - University of NottinghamOutcomes:
1. Prevalence and trends of analgesic prescribing in patients with KOA
2. Risk of falls in patients with KOA
3. Risk of all-cause mortality in patients with KOADescription: Technical Summary
Osteoarthritis (OA) is a chronic condition that affects around 7 million people in the UK resulting in pain and disability that compromise quality of life and has substantial societal and economic burdens. Management focuses on pain relief using analgesics. Recently the role of antidepressants and antiepileptic drugs (AEDs) was suggested based on findings confirming the involvement of central and neuropathic mechanisms in OA related pain. In the UK, data on drug utilisation and the associated clinical outcomes in patients with OA are limited. We aim to describe drug utilisation patterns in patients with knee OA (KOA) and investigate the association of different drug utilisation patterns with relevant clinical outcomes such as risk of fall and all-cause mortality. Starting with descriptive analysis of the patient population, utilisation of the following classes: paracetamol, NSAIDs, opioids, antidepressants and AEDs, will be measured annually between 2000 and 2015 at a population level. Prescribed doses and durations will then be described on an individual patient level over the first year after prescribing. The incidence of falls and all-cause death will be determined and associations with cumulative exposure will be investigated with the use of time to event analysis using data from the CPRD, HES and ONS.
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Predicting risk of dementia using routine electronic health records — David Reeves ...
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Predicting risk of dementia using routine electronic health records
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-15
Organisations:
David Reeves - Chief Investigator - University of Manchester
Stephen Pye - Corresponding Applicant - University of Manchester
Blossom Stephan - Collaborator - Newcastle University
Cathy Morgan - Collaborator - University of Manchester
Daniel Stamate - Collaborator - Goldsmiths University of London
Darren Ashcroft - Collaborator - University of Manchester
Elizabeth Ford - Collaborator - Brighton and Sussex Medical School
Evangelos Kontopantelis - Collaborator - University of Manchester
Fionn Murtagh - Collaborator - Goldsmiths University of London
Harm Van Marwijk - Collaborator - Brighton and Sussex Medical School
John Langham - Collaborator - Goldsmiths University of London
Mihai Ermaliuc - Collaborator - Goldsmiths University of London
Neil Pendleton - Collaborator - University of Manchester
Richard Smith - Collaborator - Goldsmiths University of LondonOutcomes:
A diagnosis of any form of dementia (generic definition)
- A diagnosis of dementia excluding certain sub-types with a specific aetiology (restricted definition)
- A code for dementia or a dementia-related condition (e.g. memory loss) (extended definition)Description: Technical Summary
Systematic reviews found 21 dementia risk prediction tools for use in population-based settings, but concluded that none of them were particularly good. One tool, which used the primary care electronic health record (EHR), was developed using traditional statistical techniques and included a limited set of cross-sectional variables. In recent years, machine learning (ML) techniques have demonstrated the potential to outperform traditional prediction methods in large-scale datasets.
This project will utilise ML techniques and the longitudinal nature of EHRs to develop an improved EHR-based tool for estimating patient risk of developing dementia. The project will investigate a broad range of previously identified, newly emerging, and novel potential predictive factors, to develop predictive models using both traditional - i.e. logistic regression - and ML techniques.
A successful primary care-based dementia risk prediction tool will aid early identification of patients most likely to benefit from preventative interventions and provide personalised information about risk to inform shared decision-making between GPs and individuals at risk.
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Nested case-control study of the impact of PSA screening on prostate cancer mortality in England — Peter Sasieni ...
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Nested case-control study of the impact of PSA screening on prostate cancer mortality in England
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-11
Organisations:
Peter Sasieni - Chief Investigator - King's College London (KCL)
Shama Sheikh - Corresponding Applicant - King's College London (KCL)
Alejandra Castanon - Collaborator - King's College London (KCL)
Christopher Mathews - Collaborator - King's College London (KCL)Outcomes:
Primary: death from prostate cancer
Description: Technical Summary
We aim to compare the PSA testing history of patients who died from prostate cancer to that of matched controls in England.
Cases will be men with records in the Clinical Practice Research Datalink (CPRD) primary care database who died from prostate cancer at age 55-84 in 2003-2017. Cases will be identified from CPRDÂs linked ONS death data.
Controls will be matched to cases on age and a range of criteria, depending on the analysis set to which they belong.Both cases and controls will have been registered with a CPRD GOLD GP practice for at least 2 years before case diagnosis  this is the period during which exposure to PSA testing will be measured. By reviewing the CPRD records, we will identify all PSA tests in this period and classify them into those likely to have been carried out for screening purposes and those carried out for other reasons. We will seek GP practice-level data on PSA testing practices and investigate the role of self-selection.
Conditional logistic regression analysis, adjusted for ethnicity, deprivation and GP practice, will be used to estimate the odds ratio of dying of prostate cancer for screened vs. non-screened men.
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A study of cardiovscular mortality and morbidity of patients with adrenal insufficiency — Desmond Johnston ...
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A study of cardiovscular mortality and morbidity of patients with adrenal insufficiency
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-26
Organisations:
Desmond Johnston - Chief Investigator - Imperial College London
Kanchana Ngaosuwan - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Stephen Robinson - Collaborator - Imperial College LondonOutcomes:
Cardiovascular mortality
- Prevalence of congestive heart failure
- Prevalence of asdrenal crisis
- Overall mortality
- Prevalence of cerebrovascular disease including transient cerebral ischaemia and intracranial hemorrhage
- Number of hospital admission
- Prevalence of myocardial infarction and ischaemic heart disease
- Other causes of death
- Prevalence of diabetes, hypertension, and dyslipidaemiaDescription: Technical Summary
A retrospective cohort study is planned. The study population comprises patients diagnosed with Addison's disease, hypopituitarism, and/or adrenal insufficiency - as per the Clinical Practice Research Datalink record - between 1st January 1987 and 31st December 2017. Outcomes of interest are risks of cardiovascular mortality, all-cause mortality, cardiovascular morbidity (myocardial infarction, ischaemic heart disease, congestive heart failure, atrial fibrillation, cerebrovascular disease, and peripheral arterial diseases), and adrenal crisis, all of which will be derived from primary care code lists, Hospital Episode Statistics and Office for National Statistics mortality information. The primary aim is to compare the cardiovascular event rate in adrenal insufficiency patients with that in a background population.
A further aim is to compare the all-cause mortality rate in adrenal insufficiency patients with that in the general population and to describe other causes of deaths in adrenal insufficiency patients. The observed rate of cardiovascular events in adrenal insufficiency patients will be compared with the expected rate, as observed in the CPRD general population, with age and sex standardization, and derivation of the standardised incidence ratio (SIR). Factors associated with cardiovascular mortality and morbidity will be evaluated using a multivariate Cox regression model. The hazard ratio with 95% confidence interval will be adjusted by age of onset, sex, and period of follow-up.
Source -
Getting sustainable, person-centred musculoskeletal health intelligence from primary care electronic health record linkage and modelling: the PRELIM initiative  Work package 3 — Daniel Prieto...
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Getting sustainable, person-centred musculoskeletal health intelligence from primary care electronic health record linkage and modelling: the PRELIM initiative  Work package 3
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-15
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Alan Silman - Collaborator - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Dahai Yu - Collaborator - Keele University
George Peat - Collaborator - Keele University
Joanne Protheroe - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Ross Wilkie - Collaborator - Keele University
Sara Khalid - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Back surgery
 Shoulder surgeryDescription: Technical Summary
The objective is to compare the provision of care for back and shoulder pain with estimates of need to map variation in shoulder and back surgical procedures across geographical regions and by level of neighbourhood deviation
In related work (ISAC protocol number 18_014R), we are developing a model to estimate the need for musculoskeletal (MSK) care using CPRD information such as age, gender, number of consultations for musculoskeletal problems, time since first consultation, pain medications prescribed, other management, and other illnesses.
In this work, we will first extract rates of surgery provision from HES data in a pre-defined 12-month period, then will compare the provision rate to the rate of need using the model identified in the related work. This measure will be calculated for each geographical region, and a map of regions in the UK will be populated. This map will demonstrate wherever there is disparity between provision and need, and the degree of the disparity at the national level. Finally, we will also look at the overall trend of rates of surgery over time since 2000.
Source -
Do NHS Health Checks improve patient's Diabetic Healthcare outcomes? A population-based study using the CPRD — Robert Aldridge ...
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Do NHS Health Checks improve patient's Diabetic Healthcare outcomes? A population-based study using the CPRD
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-26
Organisations:
Robert Aldridge - Chief Investigator - University College London ( UCL )
Vincent Nguyen - Corresponding Applicant - University College London ( UCL )
Andrew Hayward - Collaborator - University College London ( UCL )
Felix Greaves - Collaborator - Public Health England
Hannah Evans - Collaborator - University College London ( UCL )
Julian Flowers - Collaborator - Public Health England
Ruth Blackburn - Collaborator - University College London ( UCL )Outcomes:
HbA1c levels
- Vascular complications including amputations
- T2DM Incidence
- Diabetic Retinopathy incidences
- Avoidable mortality associated with DiabetesDescription: Technical Summary
Background: The NHSHC and DPP are expensive population-level interventions without strong trial-based evidence of effectiveness. Observational studies are prone to problems such as missing data, confounding and selection biases. We will evaluate the effectiveness of the programmes and compare the influence of different analytical techniques to inform future design of observational studies.
Methods: Study design: Two Retrospective Cohort studies assessing effectiveness of a) NHSC and b) DPP on diabetes health outcomes.
Target populations: those eligible for a) NHSHC (2009-16) and b) DPP (2016-2018) identified through demographic and READ code variables in Up to Standard CPRD practices.
Intervention identification: Dedicated READ codes for the NHSHC/DPP supplemented by previously established algorithms for the NHSHC.
Outcomes: Incidence of Diabetes diagnosis, HbA1c, Chronic Kidney Disease, Retinopathy and Foot Complications up to 5 years following the health checks.
Covariates include: Urinary Albumin levels, Framingham Score, and BMI.
Analytical approaches: Our primary approach is to use multiple imputation for missing data and propensity score matching (PSM) to ensure similarity of "treated" (i.e. those undergoing interventions within the programme) and "untreated" groups.
We will undertake a variety of classical and emerging epidemiological approaches to missing data, confounding and selection bias and compare predictive power of different approaches.
Source -
Risk Stratification and multimorbidity in Chronic Obstructive Pulmonary Disease (COPD) — Michael Steiner ...
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Risk Stratification and multimorbidity in Chronic Obstructive Pulmonary Disease (COPD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-08
Organisations:
Michael Steiner - Chief Investigator - Glenfield Hospital
Urvee Karsanji - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
David Groves - Collaborator - University of Oxford
Jennifer Quint - Collaborator - Imperial College London
Kamlesh Khunti - Collaborator - University of Leicester
Matt Richardson - Collaborator - NIHR Leicester Biomedical Research Centre
Neil Greening - Collaborator - NIHR Leicester Biomedical Research Centre
Rachael Evans - Collaborator - University of Leicester
Sally Singh - Collaborator - University of LeicesterOutcomes:
COPD prevalence
- Exacerbation frequency
- Comorbidities
- Mortality
- Health Resource useDescription: Technical Summary
Using R and SPSS, data will be cleaned and explored with expert consideration given to reasons, extent and remedies for missing data. Statistical models will be formed for COPD health risk, namely risk of all-cause mortality, hospitalisation (from Hospital Episode Statistics) and respiratory death (from Office of National Statistics) and we will establish whether it is best done from indices of disease severity alone or from inclusion of wider multimorbidity (cardiac disease, diabetes, hypertension, psychological disorder). Risk estimates will be derived using exemplar local specialist referral criteria including FEV1, MRC dyspnoea score, Body Mass Index (BMI), home oxygen prescription/use, exacerbations in the preceding twelve months and smoking status. BMI (height in metres divided by weight in kg squared) will be taken from the Additional Clinical file, as will smoking status. (Height, weight and smoking status being entity types 14, 13 and 4 respectively). Exacerbation of COPD will be inferred from hospitalisation due to COPD and/or CPRD Clinical file medcodes 1446 or 7884. Logistic and cox regression models will be evolved with both fixed and random effects considered. Predictive power will be assessed using the C-statistic, Sensitivity, Specificity, Positive and Negative Predictive Power, Harrell's c-index and Gonen and Heller's K statistic.
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Serum cholesterol trajectories in the years prior to lymphoma diagnosis — Joan Fortuny ...
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Serum cholesterol trajectories in the years prior to lymphoma diagnosis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; PAT IDs
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-19
Organisations:
Joan Fortuny - Chief Investigator - RTI Health Solutions
Joan Fortuny - Corresponding Applicant - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
James Kaye - Collaborator - RTI Health Solutions
Rachel Weinrib - Collaborator - RTI Health SolutionsOutcomes:
First ever diagnosis of Lymphoma (with subtypes)
- HDL cholesterol levels
- Total cholesterol levels
- LDL cholesterol levelsDescription: Technical Summary
Lymphomas are a heterogeneous group of malignancies that originate from lymphoid organs. There are several studies suggesting an association of hypocholesterolemia and lymphoma diagnosis. However, most studies have been based on only one baseline measurement of serum cholesterol. Recent research has suggested that cholesterol metabolism may be related to lymphomagenesis.
One recently published paper with participation of an investigator of the proposed study was the first to provide information on the continuous relationship of cholesterol levels with lymphoma over the 10-year period leading to a diagnosis of lymphoma. This study used a large group of lymphoma patients identified from HMO claims data in the US. To replicate these important findings, we intend to conduct a matched case control study of a different population (UK vs. US) from a different type of secondary data (EMR vs. claims) while addressing confounders that were not available in the original study (e.g., BMI, alcohol use, smoking). There are potentially large public health implications in the confirmation of differential serum cholesterol levels between patients ultimately developing a lymphoma and healthy controls in the years before diagnosis.
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Prognostic relevance of severe hypoglycaemia and factors associated with poor outcomes in subjects experiencing severe hypoglycaemia — Francesco Zaccardi ...
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Prognostic relevance of severe hypoglycaemia and factors associated with poor outcomes in subjects experiencing severe hypoglycaemia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-03
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Suping Ling - Collaborator - University of LeicesterOutcomes:
All-cause mortality
- Cardiovascular mortalityDescription: Technical Summary
This study covers the research area related to the risk stratification of long-term complications associated with severe hypoglycaemia in patients with diabetes.
Firstly, using data collected in the Clinical Practice Research Datalink (CPRD) Gold database with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS), we will investigate the association between severe hypoglycaemia and cardiovascular and all-cause mortality, and how other risk factors, such as co-morbidities and medications use, act as effect modifiers of their association. Therefore, a cohort of diabetic patients will be identified within CPRD and their exposure status (hypoglycaemia, exposed; non-hypoglycaemia, unexposed) will be defined with linkage to HES. The outcomes all-cause and cause-specific deaths will be identified via linkage to ONS. Time-to-event analysis will be used to estimate the hazard associated with specific risk factors, their interactions, and their relationship with survival probabilities (i.e., absolute risk).
Secondly, the same cohort will be used to develop and validate risk prediction models for all-cause, cardiovascular, and non-cardiovascular mortality. Model's performance will be assessed using well-established statistical methods, including discrimination, calibration, and reclassification indices. The discrimination indices will quantify, in particular, the added value of including information on severe hypoglycaemia to estimate the risk of outcomes. Moreover, model's prediction ability will be evaluated across characteristics of patients.
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Evaluating effect modification using propensity score matching and disease risk score methods: an empirical study — Liam Smeeth ...
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Evaluating effect modification using propensity score matching and disease risk score methods: an empirical study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-22
Organisations:
Liam Smeeth - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sanni Ali - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Type 2 diabetes
- Cancer
- Mortality
- Cardiovascular disease
- Acute liver injury
- Post-operative complications
- FracturesDescription: Technical Summary
Propensity score (PS) and disease risk score (also called prognostic score, DRS) methods are popular methods to account for confounding in observational studies. In evaluating effect modification in studies of drug effects or surgical interventions, treatment effect is estimated within subgroups of the effect modifier after propensity score matching (PSM). While, PSM improves balance on covariates included in the PS model, such balance cannot be assured within strata of a covariate, for example a potential effect modifier, unless further matching is done using that specific covariate. A recent literature review showed that many studies do not account for the fact that creating subgroups using a covariate, an effect modifier, will break the covariate balance created on the full PS matched set. However, the impact of the imbalance on the bias of the estimated treatment effect is not studied. In addition, alternative methods such as matching using the PS and the effect modifier or combining DRS methods and PS to evaluate effect modification has not been investigated using empirical data.
Source - and 26 more projects — click to show
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Discovery and characterization of heart failure sub phenotypes using cluster analysis methods in CPRD — Spiros Denaxas ...
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Discovery and characterization of heart failure sub phenotypes using cluster analysis methods in CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-19
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Spiros Denaxas - Corresponding Applicant - University College London ( UCL )
Daniel Swerdlow - Collaborator - University College London ( UCL )
Ghazaleh Fatemifar - Collaborator - University College London ( UCL )
Tom Lumbers - Collaborator - University College London ( UCL )Outcomes:
Heart Failure
Description: Technical Summary
Heart failure (HF) is a heterogeneous and complex syndrome with many unrecognised/undefined subtypes that respond uniquely across the range of potential therapeutic interventions currently used. Current classification relies on broad aggregate measures which may lead to overlapping groups and potentially misclassification. Since therapeutic interventions are frequently based on targeting certain patient subgroups, inadequate classification may lead to ineffective/inappropriate treatments. Improving the taxonomy of HF classification may therefore offer important clinical benefits. Whereas molecular phenotyping might theoretically provide a more rational disease description, an essential first step is to identify disease sub-types based on clinical variables that are routinely recorded in a patientÂs electronic health record.
In this study, we will use an analytical approach named clustering analysis (clustering) to identify HF subtypes in CPRD data and evaluate findings using mortality and hospitalisation. Clustering is an exploratory approach which uses a pre-defined set of clinical features to group patients into groups. Clustering has been extensively and successfully used in many respiratory conditions and in smaller studies to identify disease subtypes. Applying it to larger, higher-resolution data sources with longitudinal measurements of disease risk factors, symptoms and progression such as CPRD could lead to improved identification, characterization and treatment of HF subtypes.
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Differences in Heart Failure Care and Survival: A Comparison between United Kingdom, Sweden, Netherlands and Spain using Linked Electronic Health Care Records — Folkert Asselbergs ...
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Differences in Heart Failure Care and Survival: A Comparison between United Kingdom, Sweden, Netherlands and Spain using Linked Electronic Health Care Records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
Folkert Asselbergs - Chief Investigator - University College London ( UCL )
Alicia Uijl - Corresponding Applicant - Utrecht University
Arno W Hoes - Collaborator - Maastricht University
Chris Gale - Collaborator - University of Leeds
Harry Hemingway - Collaborator - University College London ( UCL )
Ilonca Vaartjes - Collaborator - University Medical Centre Utrecht
Marinel Cavelaars - Collaborator - Utrecht University
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Stefan Koudstaal - Collaborator - University College London ( UCL )
Tatendashe Dondo - Collaborator - University of Leeds
Vaclav Papez - Collaborator - University College London ( UCL )Outcomes:
 Temporal trends in heart failure/post myocardial infarction heart failure incidence and care across countries
 Influence of heart failure/post myocardial infarction heart failure care on mortality across countries
 Compare crude and case-mix adjusted mortality across countries
 Temporal trends for mortalityDescription: Technical Summary
Objectives
The main objectives of this study are to assess:
a. The comparison of mortality between several European countries
b. The comparison of HF treatment between several European countries
c. The interplay between MI and HF in a modern era with advanced technology in different health care systems
d. To create mappings for linked CPRD, HES and ONS data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) in order to enable the comparison between the different datasets.Methods and data analysis
We will investigate a longitudinal cohort of HF patients aged 18 years or older between 1st January 1997 and 31st July 2017. Multiple imputation will be used to impute missing variables. We will descriptively assess the baseline characteristics, treatment uptake and incidence of HF. Patients will be followed over time to estimate relative risk of mortality and treatment uptake. Cox proportional hazard models will be used to estimate crude and case-mix standardized mortality.We will compare our analyses undertaken in linked CPRD, HES and ONS data on common morbidity and mortality outcomes following diagnosis of HF and post-MI HF in the UK by replicating this in Sweden, the Netherlands and Spain using their respective registries.
Source -
Correlation of forced expiratory volume in one second with mortality and resource use in patients with asthma — Christopher Morgan ...
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Correlation of forced expiratory volume in one second with mortality and resource use in patients with asthma
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-15
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
- Corresponding Applicant -
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Mortality
Description: Technical Summary
We aim to study patterns of mortality for patients with asthma and determine the association with measurements of forced expiratory volume in one second (FEV1)). The primary objective is to determine if FEV1 is related to mortality risk in patients with asthma who have had a prior asthma exacerbation. Secondary outcomes are to assess the impact of FEV1 measurements upon non-exacerbation related mortality and all-cause mortality; and the corresponding resource use. Data will be selected from the Clinical Practice Research Datalink including linked Hospital Episode Statistics admitted patient care and accident and accident and emergency data and ONS mortality data. Subjects with asthma will be selected from between 2000-2016 by clinical code (Read code in CPRD GOLG and ICD-10 in HES). For the primary objective, patients with a moderate asthma exacerbation (based upon prescription of oral corticosteroid) and/or severe asthma exacerbation (based on inpatient or accident and emergency admission) will be identified and their previous recorded FEV1 used to stratify mortality risk in a logistic regression model. Time dependent Cox proportional hazard models will be created for the secondary mortality outcomes with FEV1 recorded as a quarterly segmented variable. Post-exacerbation resource use will be aggregated and costed using published tariffs and compared by prior FEV1 groupings.
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Risk factors of cardiovascular disease amongst users of anti-osteoporosis therapy/ies, patients with osteoporosis, or those suffering a fracture in the UK NHS: a cohort study — Daniel Prieto...
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Risk factors of cardiovascular disease amongst users of anti-osteoporosis therapy/ies, patients with osteoporosis, or those suffering a fracture in the UK NHS: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-15
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Emese Toth - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Gary Collins - Collaborator - University of Oxford
Sara Khalid - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Primary: myocardial infarction (MI), stroke
- Secondary: cardio-vascular death
- MACE1 (first occurrence of cardiovascular death, MI, or stroke)
- All-cause mortality
- MACE2 (first occurrence of all-cause death, MI, or stroke)Description: Technical Summary
OBJECTIVES
1. To estimate incidence rates of cardio-vascular outcomes and mortality amongst osteoporotic, fractured, and users of anti-osteoporosis medication/s.
2. To test the feasibility and validity of existing cardio-vascular prediction tools
3. To fit multivariable models to identify risk factors associated with cardio-vascular outcomes.METHODS
- Data sources: CPRD GOLD linked to HES-ONS data.
- Participants: three cohorts: 1.newly diagnosed with osteoporosis, 2.fracture, and 3.new users of anti-osteoporosis medication in 2000-2017, with 1+ year of data available.
- Classic cardio-vascular predictors (age, gender, body mass index, smoking and alcohol, cardiovascular history, type 2 diabetes, thrombo-embolic events, chronic kidney disease, estimated renal function, serum lipids, Charlson co-morbidity, socio-economic status, medications) as well as osteoporosis-specific ones (fracture/s history, diagnosed osteoporosis, steroids, and calcium±D supplements) will be studied.
- Outcomes: (1) myocardial infarction (MI), (2) stroke, (3) CVDeath, (4) Death, (5) MACE1 (first of MI, stroke, CVDeath), (6) MACE2 (first of MI, stroke, death of any cause)
- Follow-up: from first prescription/diagnosis to the earliest of death, transfer-out, or (for the drug user cohort) treatment cessation or switchingANALYSIS: Incidence rates will be estimated. Multivariable Cox models will be used to identify risk factors. Validity measures for existing tools will be calculated including C statistics (discrimination) and observed/expected plots (calibration). All analyses will be stratified by cohort.
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The combine effect of renin angiotensin aldosterone system blockage and Sodium-glucose co-transporter-2 receptor inhibition on renal outcomes in type 2 diabetes — Samuel Seidu ...
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The combine effect of renin angiotensin aldosterone system blockage and Sodium-glucose co-transporter-2 receptor inhibition on renal outcomes in type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-09
Organisations:
Samuel Seidu - Chief Investigator - Leicester Diabetes Centre
Samuel Seidu - Corresponding Applicant - Leicester Diabetes Centre
Francesco Zaccardi - Collaborator - University of Leicester
Hajra Okhai - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
1. End stage renal disease (<15 GFR)
2. Kidney related death using ONS cause of death
3. Renal replacement therapy (Dialysis/transplantation)
4. Doubling of creatinine from baselineDescription: Technical Summary
The objective of this research is to assess the relative impact of RAAS blockage alone, SGLT2-R inhibitors alone or the combination of both SGLT2-I and RAAS blockage on renal outcomes in people with type 2 diabetes (T2DM).
Both SGLT2-RIs, (acting on the afferent arteriole to decrease the hyper-filtration) and RAAS blockade, (acting on the efferent arterioles to decrease the hyper-filtration) lead to reductions in urinary albumin secretion. Using CPRD, we aim to assess whether the combined effect of an SGLT2-RI and RAAS blockade will be additive to decrease renal outcomes.
A retrospective cohort study design will be used to estimate the risk of incident or worsening nephropathy using the Cox regression comparing people on dual therapies vs. single therapy or no therapy. Nephropathy outcomes are defined as new onset macro albuminuria, doubling of serum creatinine, initiation of renal replacement therapy or kidney related death. Unadjusted and adjusted analyses for all relevant confounding factors available in CPRD will be performed.
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Understanding the role of serum electrolytes in the presentation of specific fatal and non-fatal cardiovascular disease syndromes: a research proposal using linked CPRD-HES-ONS data — Sandosh Padmanabhan ...
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Understanding the role of serum electrolytes in the presentation of specific fatal and non-fatal cardiovascular disease syndromes: a research proposal using linked CPRD-HES-ONS data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-08
Organisations:
Sandosh Padmanabhan - Chief Investigator - University of Glasgow
Sandosh Padmanabhan - Corresponding Applicant - University of Glasgow
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Harry Hemingway - Collaborator - University College London ( UCL )
Linsay McCallum - Collaborator - University of Glasgow
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Simon G Anderson - Collaborator - University of Manchester
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
1. All-cause mortality (identified through ONS data)
2. Fatal and non-fatal CVD outcomes:
a. Stable angina (identified from CPRD diagnoses, prescription of nitrates or from HES diagnoses)
b. Unstable angina (identified from CPRD/HES diagnoses)
c. Coronary artery disease not further specified (identified from CPRD/HES diagnoses)
d. Acute myocardial Infarction (identified from CPRD/HES diagnoses)
e. Unheralded coronary death (identified from ONS data)
f. Heart failure (identified from CPRD/HES diagnoses)
g. Ventricular arrhythmia (identified from CPRD/HES diagnoses)
h. Atrial fibrillation (identified from CPRD/HES diagnoses)
i. Sudden cardiac death (identified from ONS data)
j. Transient ischaemic attack (identified from CPRD/HES diagnoses)
k. Ischaemic stroke (identified from CPRD/HES diagnoses)
l. Stroke not further specified (identified from CPRD/HES diagnoses)
m. Subarachnoid haemorrhage (identified from CPRD/HES diagnoses)
n. Intracerebral haemorrhage (identified from CPRD/HES diagnoses)
o. Peripheral arterial disease (identified from CPRD/HES diagnoses)
p. Abdominal aortic aneurism (identified from CPRD/HES diagnoses)Description: Technical Summary
The electrolytes in serum and urine (sodium (Na+), potassium (K+), bicarbonate, (HCO3), chloride (Cl-) and calcium (Ca2+) as well as the important renal biomarkers (urea, creatinine, phosphate, urate and microalbumin) play an integral role in intermediary metabolism and cellular function. Imbalances in the intra- and extracellular concentrations of each electrolyte are associated with adverse metabolic and physiological consequences. Under normal conditions homeostasis is maintained between intake, intra/extracellular shifts and excretion. In most cases depletion or repletion of electrolytes occur in tandem, requiring consideration of related cation/anion biomarker species (e.g. Na+ and K+). Electrolyte anomalies are commonly described in hospitalized patients and are associated with increased morbidity and mortality. There are few studies however examining electrolyte anomalies in non-acute populations such as the ones encountered in primary care. The objective of this study is to examine separately, for independence, the relationship between the first recorded measurement of each biomarker and the incidence of various diagnosed CVD events and cause-specific mortality. For this longitudinal cohort of men and women aged 18 and older, we will employ risk prediction models, clustered by practice to determine the associations. Models will be validated for their discrimination, calibration and overall fit using a panel of sensitivity analyses.
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Long term impact of giving antibiotics before skin incision versus after cord clamping on children born by caesarean section: longitudinal study based on UK electronic health records — Dana Sumilo ...
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Long term impact of giving antibiotics before skin incision versus after cord clamping on children born by caesarean section: longitudinal study based on UK electronic health records
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Townsend Score; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-22
Organisations:
Dana Sumilo - Chief Investigator - University of Birmingham
Dana Sumilo - Corresponding Applicant - University of Birmingham
Brian Willis - Collaborator - University of Birmingham
Gavin Rudge - Collaborator - University of Birmingham
James Martin - Collaborator - University of Birmingham
Jon Deeks - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Magdalena Skrybant - Collaborator - University of Birmingham
Nicola Adderley - Collaborator - University of Birmingham
Peter Brocklehurst - Collaborator - University of Birmingham
Rasiah Thayakaran - Collaborator - University of Birmingham
Ruth Hewston - Collaborator - University of BirminghamOutcomes:
Primary Outcomes: Examine whether in-utero exposure to antibiotics immediately prior to birth (Intervention) compared to no pre-incisional antibiotic exposure (Comparator) in children born by caesarean section increases
- Risk of asthma
- Risk of eczemaSecondary outcomes - children: We will investigate the effect of pre-incision prophylactic antibiotics in children born by CS on
- Other allergic and allergy related diseases (food allergies and intolerance, allergic rhinitis
- Autoimmune diseases (type 1 diabetes, juvenile idiopathic arthritis, other systemic connective tissue disorders)
- Infections and inflammation (e.g. neonatal sepsis, wheeze, respiratory tract infections, respiratory conditions, gastroenteritis)
- Other immune system related conditions (leukaemia, immune deficiencies, necrotising enterocolitis)
- Healthcare utilisation (overall consultation frequency in primary care, hospital admissions)
- Less specific measures of child health (colic, failure to thrive)
- Other outcomes suggested by clinicians and parents may be added, for instance neurodevelopmental conditions (e.g. autism spectrum disorder, ADHD)Secondary outcomes - mothers: We will investigate if the effects of a reduction in post-partum maternal infectious morbidity shown in randomised controlled trials outside the UK can be replicated in the UK using routine healthcare data
- Maternal postpartum infectious morbidity (e.g. all maternal infection, endometritis, caesarean wound infection, UTI/cystitis/pyelonephritis, pelvic abscesses, respiratory infections (e.g. pneumonia), febrile illness, length of hospital stay)Description: Technical Summary
Aim:
To investigate whether the change in NICE guidance in 2011 from recommending prophylactic antibiotics after cord clamping to pre-incision antibiotics has had any effect on incidence of allergic and other related health conditions in children born by Caesarean Section (CS).Design:
A controlled interrupted time-series study using mother-baby linked data from UK primary care (CPRD).Target population:
Children born in the UK during 2006-2018 delivered by CS, compared to a control cohort delivered vaginally.Intervention and comparator:
In utero exposure to prophylactic antibiotics immediately prior to delivery by CS will be compared to no exposure when given after the cord was clamped at CS. Exposure to intra-partum antibiotics is not routinely recorded in the UK, but nearly all (98%) women undergoing CS receive prophylactic antibiotics. We will use findings from a national survey of hospitals regarding change in timing of antibiotic administration as an indicator of the probability of exposure. We will account for the cumulative increase of hospitals giving pre-incision antibiotics in our analysis.Outcomes:
Primary: Asthma and eczema.
Secondary: Other allergic and allergy related diseases, autoimmune diseases, infections and inflammation, other immune system related conditions, healthcare utilisation; maternal postpartum infectious morbidity, to assess whether the effects of pre-incision antibiotics demonstrated in randomised trials can be replicated using routine data.
Source -
Impact of ethnicity on the development of kidney disease in the UK, a retrospective database study — Gang Xu ...
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Impact of ethnicity on the development of kidney disease in the UK, a retrospective database study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation (index other than the most recent)
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-08
Organisations:
Gang Xu - Chief Investigator - University Hospitals Of Leicester
Gang Xu - Corresponding Applicant - University Hospitals Of Leicester
David Shepherd - Collaborator - Leicester City CCG
Francesco Zaccardi - Collaborator - University of Leicester
Hajra Okhai - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Nigel Brunskill - Collaborator - University Hospitals Of Leicester
Rupert Major - Collaborator - University Hospitals Of Leicester
Shafi Malik - Collaborator - University Hospitals Of LeicesterOutcomes:
Change in prevalence of CKD in South Asian groups when eGFR is reclassified using ethnic group specific eGFR formula compared to standard CKD EPI formula.
- Difference in progression of CKD in South Asian groups as reclassified by ethnic group specific eGFR calculations.
- Difference in mortality and renal failure trends in South Asian groups using reclassified eGFR.
- Risk factors associated with of CKD progression in South Asian groups compared to other ethnic group.Description: Technical Summary
Chronic kidney disease (CKD) affects up to 10% of the adult population, patients are identified using the Chronic Kidney Disease Epidemiology Collaboration CKD (CKD EPI) equation. UK registry data shows the incidence of dialysis in South Asian patients is much higher than other ethnic groups, the reason for this is not clear. The current method for detecting CKD may be improved upon using more ethnic group specific estimated glomerular filtration rate (eGFR) calculations which is currently not carried out in clinical practice.
We will carry out an observational, retrospective cohort database study using CPRD data. We will extract data for South Asian patients from the CPRD and compare the performance of an ethnic group specific eGFR formula in determining rate of decline in kidney function, development of cardiovascular complications, and mortality over a 10 year period versus the current non ethnic group specific eGFR formulae. We will also assess the risk factors associated with of CKD progression in South Asian groups compared to other ethnic groups in the UK, by using a random comparison group from the CPRD dataset.
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A retrospective cohort study using the Clinical Practice Research Datalink to assess the proportion of
pregnancy outcomes, pregnancy-related events of interest, and infant events of interest in pregnant women and their infants — Gael Dos...
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A retrospective cohort study using the Clinical Practice Research Datalink to assess the proportion of pregnancy outcomes, pregnancy-related events of interest, and infant events of interest in pregnant women and their infants
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-19
Organisations:
Gael Dos-Santos - Chief Investigator - GlaxoSmithKline - UK
Sophie Graham - Corresponding Applicant - Evidera, Inc
Deborah Covington - Collaborator - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Emmanuel ARIS - Collaborator - GSK
Huajun Wang - Collaborator - GSK
Jenna Collins - Collaborator - Evidera, Inc
Kastoori Thakuri - Collaborator - GSK
Nadia Tullio - Collaborator - GSK
Nicola Sawalhi-Leckenby - Collaborator - Evidera, Inc
Robert Carroll - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sharon MacLachlan - Collaborator - Evidera, Inc
Sonia Stoszek - Collaborator - GSK
Wendolyn Lopez - Collaborator - GSK
Yves BRABANT - Collaborator - GlaxoSmithKline Biologicals SA, BelgiumOutcomes:
The incidence proportion of the following endpoints will be estimated:
Pregnancy outcomes:
 Foetal death or still birth
 Live birth
 Preterm birth
 Terminations of pregnancies (elective or therapeutic)
Pregnancy related EIs:
 Maternal death
 Maternal sepsis
 Vaginal or intrauterine haemorrhage
 Premature labour
 Labour protraction and arrest disorders
 Pre-eclampsia and eclampsia
 Pregnancy-related hypertension
 Preterm premature rupture of membranes (PPROM)
 Oligohydramnios
 Polyhydramnios
 Intrauterine growth restriction or poor foetal growth
 Gestational diabetes mellitus
 Biliary and liver disease
 Foetal/perinatal distress or asphyxia
 Small for gestational age
 Large for gestational age
Infant EIs :
 Neonatal death within 28 days
 Infant death
 Sepsis
 Very low birth weight (<1000g)
 Low birth weight (1000-2499g)
 Macrosomia (>4000g)
 Congenital anomaliesDescription: Technical Summary
Respiratory syncytial virus (RSV) is the most common cause of upper and lower respiratory tract infections in
infants and children worldwide. There is a significant public health need to develop a maternal vaccine that can
protect neonates from RSV. Prior to initiating trials of an investigational vaccine in pregnant women, it is first
important to understand background rates of pregnancy-related outcomes and events of interest (EIs) in the
population that will be enrolled in future vaccine clinical trials. The current study uses a cohort design to estimate
the incidence proportion of specific pregnancy outcomes, pregnancy-related EIs, and infant EIs in pregnant women
and their infants. Endpoints will be identified in the Clinical Practice Research Datalink (CPRD), Hospital Episode
Statistics, and Office of National Statistics, and women will be linked to their infants using the CPRD Mother Baby
Link. A cohort of low-risk pregnant women similar to those who may be enrolled in clinical trials will be identified,
and the incidence proportion of influenza vaccination in pregnant women enrolled in the study will also be
investigated. Statistical analyses will be descriptive and the results of this study will be used to help interpret safety
data in future RSV maternal clinical trials.
Source -
A study on the epidemiology of tinnitus in the United Kingdom — Susan Jick ...
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A study on the epidemiology of tinnitus in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Nadja Alexandra Stohler - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Daniel Bodmer - Collaborator - University of Basel
Daphne Reinau - Collaborator - University of BaselOutcomes:
To assess the incidence rates of tinnitus in adult patients between 2000 and 2016 stratified by age, gender, and year of diagnosis.
To describe patient characteristics and the prevalence of comorbidities which have been associated with tinnitus in the literature prior to the onset of the disease, and to compare it to a matched comparison group of control patients without tinnitus.Description: Technical Summary
We will conduct a cohort analysis to determine incidence rates of first-time diagnosed tinnitus in the CPRD population between 2000 and 2016. We will then study various characteristics of tinnitus cases and compare them to a sample of tinnitus-free patients using a case-control design. For this purpose we will identify a matched control group of patients without tinnitus. We will assess demographic data, lifestyle factors, as well as associated comorbidities in tinnitus cases and controls and evaluate whether these factors are associated with tinnitus, by performing conditional logistic regression analysis.
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Describing monotherapy and combination use in male and female patients with treatment for Lower Urinary Tract Symptoms. A retrospective, observational study using the UK CPRD — Margarita Landeira ...
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Describing monotherapy and combination use in male and female patients with treatment for Lower Urinary Tract Symptoms. A retrospective, observational study using the UK CPRD
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-11
Organisations:
Margarita Landeira - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Mahmood Ali - Corresponding Applicant - Astellas Pharmaceuticals
Celine Quelen - Collaborator - Creativ-Ceutical
Ramzi Argoubi - Collaborator - Creativ-Ceutical
Sameh Ferchichi - Collaborator - Creativ-Ceutical
Xinyi Tu - Collaborator - Creativ-CeuticalOutcomes:
Description of the overall extent of monotherapy and combination therapy for the treatment of lower urinary tract symptoms (LUTS)
- Description of number and proportion of patients prescribed individual monotherapies and combinations for the treatment of LUTS
- Description of baseline socio-demographic characteristics of patients prescribed individual monotherapies and combinations for the treatment of LUTS
- Description of healthcare resource use associated with patients on individual monotherapies and combinations in both the 12-month pre-index and 12-month post-index periods in terms of frequency of; GP consultations, specialist referrals, urological investigations/tests, hospital admissions, surgical interventions and prescription of incontinence supplies
- Description of patient persistence with individual monotherapies and combinations during 12-months post-index in terms of time to discontinuation
- Description of number and proportion of patients to have a recorded Read-code diagnosis for a LUTS in medical records
- Description of number and proportion of patients who switched from monotherapy to combination and vice-versa in the 12-month pre-index and 12-month post-index periodDescription: Technical Summary
Background and Objectives: Drug combinations have successfully been used in many areas of healthcare to achieve better outcomes than by monotherapy alone. There is currently a lack of understanding of the Real-World landscape of combination therapy employed in the area of lower urinary tract symptoms (LUTS) in UK clinical practice. The proposed study aims to deliver key insights into this landscape in terms of therapies prescribed, and the patients who receive them.
Methods: This is a retrospective database analysis using the Clinical Practice Research Datalink (CPRD) GOLD to retrieve anonymised primary care data on LUTS patients over a three-year selection period (Jan2014-Dec2016). Male and female cohorts will be further divided by type of LUTS experienced. The extent of monotherapy and combination treatments will be described alongside persistence with each treatment. Patient demographics (age, comorbidities, polypharmacy, treatment experience and socio-economic status) will also be described. Healthcare resource use will be explored using CPRD data linkage with the secondary care, Hospital Episodes Statistics (HES) database. Treatment switching, and the presence of a read code diagnosis of LUTS will also be assessed for all patients.
Analysis: No a priori hypothesis will be tested. Aggregated summary statistics will be provided on the observations described above.
Source -
Using electronic health records to assess effectiveness of national policy in dementia recognition in the UK — Spiros Denaxas ...
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Using electronic health records to assess effectiveness of national policy in dementia recognition in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-19
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Spiros Denaxas - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Kate Walters - Collaborator - University College London ( UCL )
Martin Rossor - Collaborator - University College London ( UCL )
Maxine Mackintosh - Collaborator - University College London ( UCL )Outcomes:
Dementia diagnoses rate
- Dementia-specific medication prescription rate
- Dementia-related symptoms e.g. dementia monitoring letter rateDescription: Technical Summary
Background: The UK government has prioritised a number of key areas in dementia, as outlined in the Prime Minister's Challenge on Dementia 2020. Amongst these are improved diagnosis rate. The government has aimed to identify two thirds of people with dementia. More effective disease detection would allow patients to access more appropriate care, information and support. Information captured in the electronic health records (EHR) provides an important source of information regarding routine clinical practice and therefore an insight into how prescribing and diagnosis rates have varied over time, and as a result of what policy interventions.
Objective:
The primary objective of this study is to use primary care electronic health records (EHR) to identify which policies or medication launches were most effective in increasing rates of dementia monitoring and diagnosis
Methods & Data analysis:
We will describe the overall trend in diagnosis and monitoring of dementia, and compare a supervised and unsupervised change-point detection approach to assess the effectiveness of eight national dementia policies.Part I: We will determine the incidence rates of four dementia domains: dementia diagnosis, dementia-specific prescription, dementia monitoring and symptoms of cognitive decline, and estimate their time trends by calendar year using regression analyses.
Part II: We will conduct a supervised single change-point analysis for each of the eight policy interventions at the point at which they were released, using segmented regressions, applied individually to the three dementia domains
Part III: We will conduct unsupervised change-point analysis using the Pruned Exact Linear Time (PELT) algorithm applied to the four dementia domains
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Dipeptidyl peptidase-4 inhibitors and the risk of bullous pemphigoid among patients with type 2 diabetes — Samy Suissa ...
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Dipeptidyl peptidase-4 inhibitors and the risk of bullous pemphigoid among patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-19
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Julie Rouette - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Incident diagnosis of BP.
Description: Technical Summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors are typically used as second- to third-line treatments in the management of type 2 diabetes. While they effectively lower blood glucose via inhibition of the DPP-4 enzyme, there is some evidence that inhibiting this enzyme may generate autoimmune-related adverse events. Indeed, several case reports and few small case-control studies have suggested that use of DPP-4 inhibitors may be associated with an increased risk of bullous pemphigoid (BP), a rare blistering skin condition. However, these studies had methodological shortcomings that limit the validity of their findings. To address this question, we will assemble a cohort of approximately 170,000 patients newly-treated with antidiabetic drugs between January 2007 and March 2018. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of BP associated with use of DPP-4 inhibitors, compared with use of other second- to third-line antidiabetic drugs. Secondary analyses will assess whether risk varies by duration of use and by individual DPP-4 inhibitors.
Source -
Deriving Risk Equations for Complications of Type 2 Diabetes for the UK CPRD population — Christopher Millett ...
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Deriving Risk Equations for Complications of Type 2 Diabetes for the UK CPRD population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
Christopher Millett - Chief Investigator - Imperial College London
Eszter P Vamos - Corresponding Applicant - Imperial College London
Joseph Rigdon - Collaborator - Imperial College London
Raffaele Palladino - Collaborator - Imperial College London
Sanjay Basu - Collaborator - Stanford UniversityOutcomes:
Diagnosis of acute myocardial infarction
 Diagnosis of heart failure
 Diagnosis of stroke
 Diagnosis lower-extremity, non-traumatic amputation
 Diagnosis of nephropathy
 Diagnosis of neuropathy
 Diagnosis of retinopathy
 Death from any causeDescription: Technical Summary
We propose a retrospective open cohort study of adults with Type 2 Diabetes in the CPRD. Adults with Type 2 Diabetes over the age of 18 will be studied over the period 1 January 2008 through 31 December 2017. The outcomes of interest: fatal coronary heart disease event or non-fatal acute myocardial infarction or coronary revascularization; fatal or non-fatal stroke (haemorrhagic or ischemic); first exacerbation of congestive heart failure; retinopathy leading to photocoagulation, or vitrectomy; nephropathy defined as microalbuminuria or stage 3-5 renal disease; neuropathy defined based on diagnostic codes or pressure sensation loss by monofilament test; lower-extremity non-traumatic ulcer; and death from any cause. Cox models will be fit to the time-to-event data for each outcome among people without history of the outcome at the beginning of the study period. Covariates in the models will include patient demographics, biomarkers, co-morbid disease history, and medications. An additional analysis will be performed by comparing equations developed through traditional Cox models to models alternatively derived using a novel machine learning approach called DeepSurv, which enables a neural network to be estimated to address potential complex interactions between covariates, both right- and left-censoring, and meaningful missing data patterns.
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A cohort study investigating the association of flucloxacillin and liver injury within people previously exposed to the drug — Kevin Wing ...
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A cohort study investigating the association of flucloxacillin and liver injury within people previously exposed to the drug
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-03
Organisations:
Kevin Wing - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Louise Pealing - Collaborator - University of Oxford
Patrick Bidulka - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Riaz Aziz - Collaborator - University College London ( UCL )Outcomes:
Drug-induced liver injury
Description: Technical Summary
This study aims to quantify the association between being prescribed flucloxacillin and serious drug-induced liver injury within people who have already previously completed a course of flucloxacillin therapy. Two different liver injury outcomes will be assessed: a symptom-defined outcome (jaundice) and a laboratory confirmed outcome (any of a number of symptoms indicating liver injury along with a liver test result indicative of drug-induced liver injury). The 1-45 day risk for each outcome in the flucloxacillin-exposed group will be calculated and compared to the 1-45 day risk in a group of patients consisting of people prescribed oxytetracycline, a comparator antibiotic that is prescribed for similar indications. Relative effects will be calculated as odds ratios, which will be interpreted as risk ratios given the rarity of the outcome under study (likely to be less than 8 per 100 000 in the general population of users). Logistic regression will then be used to estimate a risk ratio adjusted for important confounders of the association. Variables considered as confounders of the association will include age, gender, smoking, ethnicity, BMI, alcohol intake, socio-economic status, use of other drugs known to cause liver injury and calendar period.
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Impact of atrial fibrillation (AF) awareness campaigns on the rate of AF related consultations in UK primary care: an interrupted time series analyses — Sreeram Ramagopalan ...
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Impact of atrial fibrillation (AF) awareness campaigns on the rate of AF related consultations in UK primary care: an interrupted time series analyses
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-08
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Cormac Sammon - Corresponding Applicant - PHMR Associates
Jeshika Singh - Collaborator - PHMR Associates
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Victoria Allan - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )Outcomes:
Atrial fibrillation diagnoses
 Pulse checks
 ECG tests
 Anti-arrhythmic prescriptions
 Oral anti-coagulant prescriptions
 Parenteral anti-coagulant prescriptions
 Irregular pulse
 Palpitations
 Breathlessness
 Chest pain
 Anti-platelet prescriptions
 Cardiovascular referralsDescription: Technical Summary
It remains unclear whether heart rhythm awareness campaigns lead to increases in GP consultations and ultimately to diagnoses of new cases. The aim of this study is to investigate the impact of two atrial fibrillation (AF) related awareness campaigns (World Heart Rhythm Week (WHRW) and Global AF Aware Week (GAFAW)) on the frequency of primary care consultations related to AF in the United Kingdom (UK).
Individuals that are 18 years and above, with a minimum of 1 year of baseline data or continuous registration at a CPRD practice, and without prior record of diagnoses of AF will be included in the study population. The frequency and rate of signs, symptoms and diagnoses related to AF will be calculated in each calendar week between 2012 and 2017 (inclusive).
An interrupted time series analysis will be adopted to estimate the level and trend in rates in the baseline period and changes in level and trend post intervention. The post-intervention impact is assumed to last for 8 weeks in the analysis. Analyses will be adjusted for seasonality, subgroup analyses will be used to explore the impact of the intervention by sex, age and deprivation and sensitivity analyses will explore the impact of the length of post-intervention period.
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Better Targeting of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease — Roger Knaggs ...
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Better Targeting of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-19
Organisations:
Roger Knaggs - Chief Investigator - University of Nottingham
Kimberley Sonnex - Corresponding Applicant - University of Nottingham
Harmony Otete - Collaborator - University Of Central LancashireOutcomes:
Primary:
⢠Exacerbations of COPD
⢠Lung function, measured by FEV1
Secondary
⢠Hospital admissions due to COPD exacerbation download
⢠Time to exacerbation after initiation of therapy
⢠Time to hospitalisation with COPD exacerbation after initiation of therapy
⢠All-cause mortality
⢠Respiratory-cause mortalityDescription: Technical Summary
Advances have been made in identifying factors in people with COPD who may gain more benefit from inhaled corticosteroids (ICS), regardless of the severity of their disease. Such factors include inflammation caused by eosinophilia, non-smoking status and co-diagnosis of asthma. It is postulated that ICS will be more beneficial for people with these factors due to underlying lung inflammation caused by eosinophils, which is known to be highly responsive to ICS. This research will determine if the aforementioned variables have an effect on the effectiveness of ICS in people with COPD. The Clinical Practice Research Datalink (CPRD) will be analysed. Inclusion criteria are all patients with a diagnosis of COPD, confirmed by spirometry between 2004 and 2013 and who have received at least one COPD medication. Data from the CPRD database will be linked to hospital episode statistics (HES) for hospitalisations due to COPD exacerbations. Survival analysis (using Coxâs Regression) will be used to assess time to exacerbation, time to hospitalisation after initiation of ICS, and time to death versus people with COPD who have never received an ICS. There will be a sub-group analysis of co-variates, including those with an asthma diagnosis, smoking status and eosinophilia. In addition time series analysis, using a panel data model will be undertaken to assess rate of decline of lung function and yearly exacerbation and hospitalisation rates in those patients who have over 50% persistence with ICS, with asthma diagnosis, smoking status and eosinophilia variables.
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Impact of subsequent major adverse cardiovascular events on mortality in a post-myocardial infarction population: a retrospective UK database analysis — Raquel Lahoz ...
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Impact of subsequent major adverse cardiovascular events on mortality in a post-myocardial infarction population: a retrospective UK database analysis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
Raquel Lahoz - Chief Investigator - NOVARTIS
Raquel Lahoz - Corresponding Applicant - NOVARTIS
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Joaquim Cristino - Collaborator - NOVARTIS
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Major adverse cardiovascular events
Description: Technical Summary
Incidence of myocardial infarction (MI) is predictive of subsequent major adverse cardiovascular event (MACE). In this study, we wish to identify patients with incident first MI events and to estimate the increased mortality risk associated with subsequent MACE events. The CPRD GOLD and linked datasets (HES admitted patient care and mortality) will be used. The study will be limited to CPRD acceptable patients, registered at an up-to-standard practice who are eligible for the CPRD linkage scheme. Patients with MI will be identified during the study period (2006-16) based or ICD-10 code within the HES admitted patient care database. Date of first diagnosis will be the index date. The baseline characteristics of the cases will be presented. A time-dependent Cox model for each outcome (all-cause mortality, MACE mortality and individual components) will be created with subsequent events defined within quarterly segments. Secondary outcomes comprise the individual components of MACE, lung cancer and infections. We also wish to describe the MI population in terms of social demography and to estimate the resource utilisation subsequent to first MI event.
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Bile acid sequestrants and risk of selected age-related diseases — Shahinaz Gadalla ...
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Bile acid sequestrants and risk of selected age-related diseases
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
Shahinaz Gadalla - Chief Investigator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Corresponding Applicant - National Cancer Institute ( NCI )
Jodi Segal - Collaborator - Johns Hopkins School of Medicine
Madhav Thambisetty - Collaborator - National Institutes of Health - USA
Vijay Varma - Collaborator - US-NIH
Youjin Wang - Collaborator - National Cancer Institute ( NCI )Outcomes:
Dementia
 AlzheimerÂs disease
 Cancer (all and by site)Description: Technical Summary
BAS are a class of lipid modifying treatments (LMTs) used to lower LDL cholesterol levels by binding to bile acids in the gut and lowering their levels in blood. Evidence from animal models suggests that bile acids may have important roles to play in influencing neurodegeneration and carcinogenesis. Using a metabolomics approach, Dr. ThambisettyÂs group (study co-investigator) previously showed altered levels of some bile acids in patients with mild cognitive impairment (MCI), a condition that may represent early stages of AlzheimerÂs disease (AD). He also recently observed that serum concentrations of bile acids are associated with patterns of brain atrophy similar to those seen in patients with AD 1. Studies of the effect of bile acid on cancers suggest possible organ-specific variations. There is a line of evidence that excessive bile acid increases the risk of gastrointestinal cancers. On the other hand, a recent In-Vitro study showed that lithocholic acid, a secondary bile acid reduced breast cancer cell proliferation. Here, we propose to evaluate the effect of BAS on individualÂs risk of age-related neurodegenerative diseases (namely, dementia and AD), and cancer. We propose a matched double cohort design in which we will compare the risk of study outcomes between new users of BAS and new users of other non-statin lipid lowering drugs. Both groups will be matched on age, sex, practice, and prior statin use.
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Understanding the impact of the routine use of anti-diabetic (PPAR gamma)/anti-hyperlipidaemic (PPAR alpha) medication on risk of brain tumours and case fatality — Yoav Ben...
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Understanding the impact of the routine use of anti-diabetic (PPAR gamma)/anti-hyperlipidaemic (PPAR alpha) medication on risk of brain tumours and case fatality
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-23
Organisations:
Yoav Ben-Shlomo - Chief Investigator - University of Bristol
Yoav Ben-Shlomo - Corresponding Applicant - University of Bristol
Kathreena Kurian - Collaborator - University of Bristol
Mio Ozawa - Collaborator - University of Bristol
Richard Martin - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of BristolOutcomes:
Brain tumour (primary and secondary)
- DeathDescription: Technical Summary
Brain cancer (primary and secondary brain cancer) has an extremely poor overall survival with less than 3% patients alive after 5 years. There has been interesting preliminary evidence suggesting that diabetic patients receiving peroxisome proliferator-activated receptor gamma (PPAR gamma) agonists, a group of anti-diabetic, thiazolidinedione drugs, have an increased median survival for primary brain cancer glioblastoma. Another study has shown that glioblastoma brain cancer patients with a high level of PPAR alpha gene expression have an improved overall survival. However, at present, no clinical trials are under-way with regards to treating glioma patients using PPAR gamma or PPAR alpha agonists. This study aims to evaluate the potential of PPAR gamma and PPAR alpha agonists in prevention and as novel neoadjuvants in the treatment (tertiary prevention) of brain cancer. We will conduct 2 nested case-control studies to investigate, using multivariable logistic regression, whether the exposure to PPAR gamma or PPAR alpha agonist has an effect on diagnosis of brain cancer. A clinical cohort study will use multivariable proportional hazard models to determine whether exposure to these medication is associated with reduced case fatality.
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Use of renin angiotensin system inhibitors and incident treated depression, and nonfatal or fatal self-harm — Patrick Souverein ...
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Use of renin angiotensin system inhibitors and incident treated depression, and nonfatal or fatal self-harm
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-15
Organisations:
Patrick Souverein - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Coen Stehouwer - Collaborator - Maastricht University
Johanna Driessen - Collaborator - Utrecht University
Patrick Souverein - Collaborator - Utrecht University
Thomas van Sloten - Collaborator - Maastricht University Medical CentreOutcomes:
Treated depression
 Hypertension
 Suicidal attempts
 Renin angiotensin system inhibitors
 Completed suicide
 Use of other antihypertensive drugsDescription: Technical Summary
It has been suggested that cerebral microvascular dysfunction is an important contributor to depression in older individuals. Renin angiotensin system (RAS) inhibitors can improve cerebral microvascular function via multiple mechanisms. However, it is unknown whether these medications can protect against depression. We will therefore conduct a pharmacoepidemiologic study using a propensity score-matched cohort design to study whether RAS inhibitors protect against depression.
In the Clinical Research Practice Datalink, we will determine all adults with hypertension, but without a prior diagnosis of depression, from 2004 onwards. We will compare initiators of RAS inhibitors versus thiazide(-like) diuretic initiators. Thiazides will be used as a control group, because they are not associated with mood disorders. Thiazides are, however, considered a second?line treatment for hypertension. We will therefore require patients in both groups to have previously used ?1 other class of an antihypertensive drug. The primary outcome is a composite end point of treated depression and nonfatal and fatal self-harm. We will apply Cox regression with propensity score matching to control for confounding.
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Describing treatment and survival of children with congenital heart anomalies — Laila Tata ...
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Describing treatment and survival of children with congenital heart anomalies
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-11
Organisations:
Laila Tata - Chief Investigator - University of Nottingham
Laila Tata - Corresponding Applicant - University of Nottingham
Jack Gibson - Collaborator - University of Nottingham
Linda Fiaschi - Collaborator - University of Nottingham
Lu Ban - Collaborator - University of Nottingham
Toluwalope Yetunde Onuwe - Collaborator - University of NottinghamOutcomes:
Survival of children with congenital heart disease
⢠Causes of death for children with congenital heart diseaseDescription: Technical Summary
Congenital Heart Defects (CHD) account for nearly one-third of all major congenital anomalies and an increasing number of children with CHD are living into adulthood. Our objective is to describe the survival of children diagnosed with CHD up to the age of 20 years, overall and across subtypes of CHD that range from milder small ventricular septal defects to more severe and complex conditions such as tetralogy of Fallot. To identify which children have CHD by subtype, we will combine diagnostic codes from primary care and secondary care hospital episode statistics (HES), surgical/intervention codes specific to CHD repair and treatment from HES, and office of national statistics causes of death. We will describe mortality (survival rates) at different ages according to factors such as subtype, sex, ethnicity and socioeconomic group. We will also use survival curves and Cox regression analysis, taking into account the timing of interventions and other potentially contributing factors such as sex, ethnicity and socioeconomic group to enable comparison of their survival to the general population.
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Study of recovery in patients hospitalised with community acquired pneumonia using Clinical Practice Research Datalink (CPRD), linked to Hospital Episode Statistics — Tricia McKeever ...
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Study of recovery in patients hospitalised with community acquired pneumonia using Clinical Practice Research Datalink (CPRD), linked to Hospital Episode Statistics
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Carstairs Index for 2011 Census (Excluding Northern Ireland); Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-22
Organisations:
Tricia McKeever - Chief Investigator - University of Nottingham
Vadsala Baskaran - Corresponding Applicant - Nottingham University Hospitals
Christos Chalitsios - Collaborator - University of Nottingham
Wei Shen Lim - Collaborator - Nottingham University HospitalsOutcomes:
Primary outcomes
 Reconsultation rate following hospitalisation for CAP, stratified by time: within the first 7 days, 8- 14 days, 15- 30 days, 31- 60 days
 Causes of reconsultation; respiratory versus non-respiratory (cardiac, cognitive impacts)
 Antibiotic prescription rate at reconsultationSecondary outcomes
 Types of antibiotics prescribed at reconsultation
 Association of antibiotic prescription at reconsultation with further reconsultation episodes within 30 days
 Assocation of reconsultation with underlying comorbid illnesses
 Incidence of incipient cognitive decline and cardiac disease following CAP at 30 days, 90 days and 1 year.Description: Technical Summary
Objectives
To determine the incidence and reasons for reconsultation following hospitalisation with CAP, including antibiotic usage at reconsultation.Methods
Adults with a first episode of hospitalised CAP between July 2002- June 2017 as recorded in CPRD linked to HES based on ICD-10 codes (J12- J18) will be included.Data analysis
Statistical analyses will be performed using Stata 15. Incidence of CAP and other diseases (cognitive decline and cardiac complications) following CAP will be estimated using the whole CPRD as the denominator population. Incidence rates per 100,000 person-years, adjusted incidence rate ratios and 95% confidence intervals will be described.The independent association between patient characteristics and rate of reconsultation (overall/ patients without co-morbidities /patients with underlying respiratory disease) will be calculated using a competing-risks regression with death and readmission as competing events; adjusted for age, gender, smoking, alcohol consumption, practice region, primary care consultation in the previous year, social deprivation, co-morbidities, vaccine status, length of hospital stay, and admission year. Causes of reconsultation will be divided into either respiratory or non-respiratory (cardiac symptoms and cognitive decline) symptoms. We will measure the number of antibiotic prescriptions at reconsultation and where possible, the type of antibiotics prescribed. Association of antibiotic prescription at reconsultation with further reconsultation episodes will also be analysed.
Proportion of patients who received smoking cessation advice before and after the index pneumonia episode will be calculated. The rate of pneumonia recurrence (per 100 person-years) will be determined by smoking status. Effect of smoking on hospitalization for recurrence of pneumonia will be determined using competing-risks regression (death as a competing event), adjusted for variables determined using directed acyclic graph (DAG).
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The extent of medication complexity in general practice — Rachel Denholm ...
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The extent of medication complexity in general practice
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-09
Organisations:
Rachel Denholm - Chief Investigator - University of Bristol
Rachel Denholm - Corresponding Applicant - University of Bristol
Rupert Payne - Collaborator - University of Bristol
Thomas Greenslade - Collaborator - University of BristolOutcomes:
Medication Regime Complexity Index
Description: Technical Summary
Prescribing is a key therapeutic intervention offered by doctors, the majority occurring in primary care. With an ageing, multimorbid population, the number of patients taking multiple medication in the UK is increasing. Yet, patients' medication regimes differ depending on the drugs prescribed, and little is known about the epidemiology of medication complexity in the general population.
A random sample of 300,000 patients aged 1 year or more will be selected and medication regimen complexity index (MRCI) score calculated for a random date in 2017. MRCI score will be compared across age, sex, socio-economic status and multimorbidity groups. In a second sample, 50,000 patients who had a medication review in 2017 will be matched to 50,000 patients who did not. A difference-in-difference analysis will be conducted using multivariable regression to compare changes in MRCI score before and after the medication review in exposed and unexposed patients. Adjustments will be made for age, gender, socioeconomic status, long-term morbidities, and GP surgery.
This work will provide greater insight into the medication burden of the general UK population, and evaluate how successfully current medication reviews are in simplifying medication regimes. Understanding these issues will inform the development of interventions for improving medication optimisation.
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Asthma and Type 2 Co-morbidities — David Price ...
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Asthma and Type 2 Co-morbidities
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jaco Voorham - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Arul Earnest - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Fen Ye - Collaborator - SANOFI
Siddesh Kamat - Collaborator - Regeneron PharmaceuticalsOutcomes:
Phase 1
- No health outcomes are measured, only co-morbidity co-occurrence are analysed
Phase 2
- Primary outcome: Asthma severity, measured with separate 3 indicators
- Number of severe asthma exacerbations (an asthma-related hospital admission and/or A&E attendance and/or an acute course of oral corticosteroids).
- Risk Domain Asthma Control (RDAC): Absence of severe asthma exacerbations, and no antibiotic prescribed with evidence of a lower respiratory consultation
- Overall asthma control: Achieving RDAC and a mean daily dosage of </=200 µg salbutamol or </=500 µg terbutaline used
- Secondary outcome: Asthma-related healthcare resource utilisation and costs, composed of
- Primary care consultations
- Prescribed medication
- Respiratory medication
- Chronic oral corticosteroids
- Biologics
- Antibiotics
- Outpatient visits
- Emergency room attendances
- Inpatient hospital admissionsDescription: Technical Summary
Asthma is a common long-term condition which is responsible for considerable morbidity, mortality and costs. There are several related conditions, involving type 2 inflammation which have been identified as affecting asthma outcomes. The nine T2 co-morbidities of interest are: eczema, allergic rhinitis, chronic rhinosinusitis, nasal polyps, urticaria, allergic conjunctivitis, food allergy, eosinophilic oesophagitis and anaphylaxis. Because of the common underlying disease process, it has been suggested that successful treatment of one might also improve related conditions.
The frequency with which these conditions co-occur in patients with asthma has not yet been described, nor has the relationship between co-morbidity patterns with asthma severity and asthma-related resource utilisation.
The aim of this study is to describe the frequency and interrelations of these conditions, and assess associations with asthma severity, asthma-related healthcare resource utilisation and costs, within a real-world asthma population.
The prevalence of each co-morbidities pattern will be measured, and associations between co-morbidities described using likelihood ratios and principal component analysis. This will be used to select a subset of patterns, in which patient characteristics, asthma severity, healthcare resource utilisation and cost will be compared using multivariable regression models, in all patients and stratified by asthma severity, co-morbidity severity and activity, blood eosinophil count and age.
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Defining patient groups at short-term high risk of fracture and evaluating current practice of osteoporosis treatment and rate of different fractures and cardiovascular events in these patient groups — Alireza Moayyeri ...
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Defining patient groups at short-term high risk of fracture and evaluating current practice of osteoporosis treatment and rate of different fractures and cardiovascular events in these patient groups
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-07-31
Organisations:
Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Alireza Moayyeri - Corresponding Applicant - UCB Pharma SA - UK
Corinna Hong - Collaborator - UCB Pharma SA - UK
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Emese Toth - Collaborator - UCB Biopharma SRL - Belgium Headquarters
John Logan - Collaborator - UCB Pharma SA - UK
Paul McDwyer - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Victor Kiri - Collaborator - UCB BioSciences, Inc.Outcomes:
Osteoporotic fractures
Osteoporosis treatment
Cardiovascular events (stroke, MI, death)Description: Technical Summary
Patients at short-term (i.e. in 1- or 2-years) high risk of fracture (imminent risk) can be targeted for stronger/faster-acting treatments. Hence, we aim to define several patient populations with imminent fracture risk and to compare 1) incident fracture rates; 2) osteoporosis treatment; 3) cardiovascular events (myocardial infarction and stroke) in these populations. We will use CPRD data linked to Hospital Episode Statistics (HES) inpatient data and Office of National Statistics (ONS) mortality data. All female patients aged 50+ on 1/1/2015 and registered in CPRD for a minimum of 1 year will be evaluated and assigned to a 'general cohort'. Several sub-cohorts with imminent fracture risk will be defined based on diagnosis of osteoporosis or the type and number of fractures before 1/1/2015. Patients can be eligible to be included in more than one of these cohorts. Demographics, clinical characteristics, comorbidities and medications will be recorded for all patients at the baseline (i.e. 1/1/2015). Patients will be followed through linked CPRD-HES-ONS data until 31/12/2016, and rate of incident fractures, number of patients treated for osteoporosis, and rate of cardiovascular events (myocardial infarction/stroke/cardiovascular death) in 1- and 2-year follow-up periods will be calculated and presented for different cohorts.
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2018 - 06
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Descriptive Analysis of Pro-Arrhythmic Risk of Drug Therapies — Robbert Zusterzeel ...
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Descriptive Analysis of Pro-Arrhythmic Risk of Drug Therapies
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-13
Organisations:
Robbert Zusterzeel - Chief Investigator - Food and Drug Administration - FDA
Robbert Zusterzeel - Corresponding Applicant - Food and Drug Administration - FDA
Veronica Sansing-Foster - Collaborator - Food and Drug Administration - FDA
Xie Diqiong - Collaborator - Food and Drug Administration - FDAOutcomes:
Torsade de Pointes
- Cardiac Arrest
- Abnormal/prolonged QT
- Arrhythmia
- Sudden cardiac death
- Ventricular abnormalities
- Tachycardia
- MortalityDescription: Technical Summary
This proposed study aims to assess the incidence of cardiac arrhythmia and cardiac mortality in patients using different Comprehensive in Vitro Proarrhythmia Assay (CiPA) drugs that were non-empirically identified as having varying risk of Torsade de Pointes (Torsade), a potentially fatal cardiac arrhythmia. The CiPA initiative was established by international government agencies, academia and pharmaceutical companies to develop a new paradigm for assessing proarrhythmic risk of drugs (in addition to only QT prolongation), building on the emergence of new technologies and an expanded understanding of the mechanisms of arrhythmia.
The different drugs in the CiPA risk categories are based on expert opinion from an international panel and have not been thoroughly assessed for actual arrhythmic risk. There are 28 drugs within different Torsade risk categories (low, medium, and high) on the list for validation of the new CiPA paradigm (Appendix). The proposed research would help to descriptively quantify real-world arrhythmia risk for the different categories within CiPA and use this information to determine if the 28 drugs are accurately categorized in terms of their risk categories under CiPA. In addition, since Torsade is more common in women and the proposed CiPA paradigm does not initially take sex into consideration, we will assess the appropriate categorization of CiPA drugs in women and men, separately.
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Deriving parameters of long-term cardiovascular outcomes and health care utilisation for a cost-effectiveness model in patients with familial hypercholesterolaemia diagnosed in primary care — Stephen Weng ...
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Deriving parameters of long-term cardiovascular outcomes and health care utilisation for a cost-effectiveness model in patients with familial hypercholesterolaemia diagnosed in primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-10
Organisations:
Stephen Weng - Chief Investigator - University of Nottingham
Stephen Weng - Corresponding Applicant - University of Nottingham
Barbara Iyen - Collaborator - University of Nottingham
Beth Woods - Collaborator - University of York
Miqdad Asaria - Collaborator - The Health Foundation
Nadeem Qureshi - Collaborator - University of Nottingham
Pedro Saramago Goncalves - Collaborator - University of York
Ralph Kwame Akyea - Collaborator - University of Nottingham
Rita Neves De Faria - Collaborator - University of York
Susan Griffin - Collaborator - University of YorkOutcomes:
Death due to cardiovascular event
- Stroke (ischaemic and haemorrhagic)
- Peripheral arterial disease
- Death due to other causes
- Transient ischaemic attack
- Hospitalisations (Cost outcomes)
- Acute coronary syndrome
- Stable anginaDescription: Technical Summary
Background: Familial Hypercholesterolaemia (FH) is a common inherited cause of raised cholesterol. To support development of cost-effectiveness models, information regarding the long-term consequences and costs of FH is required.
Aims: To build a robust multi-state model predicting the long-term rates of cardiovascular events and cost utilisation amongst FH patients diagnosed in primary care.
Participants: 3,182 CPRD patients diagnosed with FH from the 1 Jan 1999 with known eligibility for linkage to Hospital Episodes Statistics.
Methods: Data will be analysed using a form of survival analysis called multi-state modelling. Parametric survival models will be used to facilitate extrapolation of event rates over the full lifetime of the FH patients. Estimates of event rates will be conditioned upon patients' baseline demographic, clinical characteristics and lipid lowering treatment, using multivariate parametric survival regressions. Through the development of an economic model, we will estimate the costs falling on the NHS budget associated with the cardiovascular and fatal events.
Outputs: Estimated parameters from the survival analysis will inform the economic model to produce estimates of: the life expectancy of FH patients, expected time to cardiovascular and non-cardiovascular events, expected cardiovascular and non-cardiovascular mortality, the costs of cardiovascular and non-fatal events and the total costs and consequences for FH patients.
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Risk factors for overtreatment and undertreatment of glucose-control in patients with diabetes mellitus and association of overtreatment with mortality — Francesco Zaccardi ...
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Risk factors for overtreatment and undertreatment of glucose-control in patients with diabetes mellitus and association of overtreatment with mortality
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-27
Organisations:
Francesco Zaccardi - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
David Kloecker - Collaborator - Leicester Diabetes Centre
Kamlesh Khunti - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Samuel Seidu - Collaborator - Leicester Diabetes Centre
Suping Ling - Collaborator - University of LeicesterOutcomes:
Cardiovascular mortality
- All-cause mortalityDescription: Technical Summary
Using data collected in the CPRD Gold database with linkage to HES admitted patient care and ONS death registration, the primary aim of the study is to characterise patients with type 2 diabetes mellitus at risk of overtreatment and undertreatment. Secondly, the characteristics associated with the risk of future outcomes will be identified in overtreated patients. In particular, this study will include a retrospective cohort of patients with a diagnosis of type 2 diabetes mellitus aged over 30 years old and risk prediction models will be developed to estimate the probability for a patient to be overtreated with glucose-lowering medications (3 consecutive values of HbA1c <7% in patients on any insulin or any sulphonylurea and over 70 years old) and undertreated (3 consecutive values of HbA1c >8% in patients on any glucose-lowering drug and younger than 70 years old). In addition, in overtreated subjects the characteristics associated with cardiovascular mortality and all-cause mortality will be assessed.
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Replication of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) in a cohort study using electronic primary care data — Olaf Klungel ...
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Replication of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) in a cohort study using electronic primary care data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-07
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Katrien Oude Rengerink - Collaborator - University Medical Centre Utrecht
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Turki Althunian - Collaborator - Utrecht UniversityOutcomes:
Composite endpoint of stroke or systemic embolism (primary)
- Major bleeding (secondary)Description: Technical Summary
Objectives: To assess the generalizability of the results of clinical trials in real-life settings with further investigation of the application of non-inferiority analysis in observational studies.
Methods: the design of the ROCKET AF non-inferiority trial (rivaroxaban vs. warfarin) will be replicated, apart from randomization, in a retrospective cohort study using the CPRD. Patients with atrial fibrillation (AF) who started rivaroxaban or warfarin will be included in the period from 2008 to 2017. The primary aim is to assess whether non-inferiority can be demonstrated for rivaroxaban vs. warfarin in terms of the composite endpoint of stroke (ischaemic or haemorrhagic) or systemic embolism, and whether these results extend to those AF patients who did not meet the eligibility criteria of the trial).
Data analysis: We will perform an analysis that replicates the primary analysis of the ROCKET-AF trial: a Cox proportional hazards regression analysis will be used to estimate the effect of rivaroxaban vs. warfarin, while adjusting for many possible confounders (including time-varying confounders). Non-inferiority will be tested using the same margin as used in the ROCKET-AF trial (HR 1.46).
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Investigating healthcare utilisation for heart failure patients with or without cardiac implantable electronic devices in England: retrospective cohort study. — Alex Bottle ...
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Investigating healthcare utilisation for heart failure patients with or without cardiac implantable electronic devices in England: retrospective cohort study.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-17
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Alex Bottle - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Martin Cowie - Collaborator - King's College London (KCL)
Wun Wong - Collaborator - Imperial College LondonOutcomes:
Hospital use (ED visits, admissions, OPD attendances)
- GP appointments
- Death
- Use of heart failure medicationsDescription: Technical Summary
The study comprises retrospective cohort analyses examining healthcare utilisation and service outcomes for heart failure (HF) patients with or without a Cardiac Implantable Electronic Device, CIED, in England, diagnosed or with a device implanted between April 2010 and March 2012. For each patient group (those with CRT, ICD, LVAD or none), each kind of NHS contact (primary/secondary care) will be compared, with patient contacts summarised for 5 years after device implantation or first HF admission (diagnosis date will be used instead for HF patients without CIED). Standard national NHS reference costs for the relevant year will be applied for each contact.
Analyses will begin with descriptive comparisons of HF patient groups by their socio-demographic factors, LOS and co-morbidities followed by logistic regression. We will attempt to infer, to extent possible, causal effects and other associations between device implantation and subsequent resource usage by use of propensity score matching on socio-demographic factors and co-morbidities. Using the matched groups, logistic regression models will be constructed with device (CRT, defibrillator, LVAD or none) as the treatment of interest; the outcome will be total cost during the five years following device implantation or diagnosis dichotomised into highest quintile vs lowest four quintiles.
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Health Impact Assessment to predict the impact of an increase in tobacco pricing on the burden of COPD in Italy, Sweden and the United Kingdom — Jennifer Quint ...
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Health Impact Assessment to predict the impact of an increase in tobacco pricing on the burden of COPD in Italy, Sweden and the United Kingdom
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-19
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Elaine Fuertes - Corresponding Applicant - Imperial College London
Alicia Gayle - Collaborator - Imperial College London
Cosetta Minelli - Collaborator - Imperial College London
Debbie Jarvis - Collaborator - Imperial College LondonOutcomes:
Overall mortality
- COPD 1-year mortality rate
- COPD excess mortality
- COPD incidence
- COPD prevalenceDescription: Technical Summary
Using the Health Impact Assessment tool "DYNAMO-HIA" and data from Italy, Sweden and the United Kingdom, we will quantify the reductions in future COPD prevalence and incidence that would occur over a 40-year time frame if tobacco prices increased by 25% and 50%, compared to a business-as-usual scenario. DYNAMO-HIA uses a Markov-based modelling approach to model age and sex group specific probabilities of staying or moving to a risk factor (smoking) group under certain scenarios, and quantifies how this affects future risk factor (smoking) and disease (COPD) trends.
Demographic and smoking behaviour information will be country-specific and obtained from local resources. COPD disease data will be obtained from the CPRD and used for all three countries. The CPRD study population will consist of a 1 million person random sample of patients 6 - 95 years-old contained within the CPRD record between 01/01/ 2015 and 31/12/2017. Doctor diagnosed COPD prevalence, incidence, excess mortality and 1-year mortality rates will be calculated and inputted into DYNAMO-HIA alongside demographic and smoking behaviour information.
This work, a part of the ALEC study, will inform policies aimed at reducing smoking rates and their impact on the burden of COPD.
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Withdrawing inhaled corticosteroid (ICS) treatment in people with COPD: a real world study — Jennifer Quint ...
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Withdrawing inhaled corticosteroid (ICS) treatment in people with COPD: a real world study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-21
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Debbie Jarvis - Collaborator - Imperial College London
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
Time to first exacerbation of COPD (AECOPD)
Change from baseline in FEV1
Time to first severe AECOPD
Adverse events (pneumonia, cardiac event, stroke)
Number of moderate or severe AECOPD
Change from baseline in dyspnoea (using modified Medical Research Council (mMRC))Description: Technical Summary
Chronic Obstructive Pulmonary Disease (COPD) patients are treated with short/long-acting bronchodilator inhalers. If symptoms persist or patients experience exacerbations of COPD (AECOPD) they are prescribed inhaled corticosteroids (ICS). The risks and benefits of ICS in the treatment of COPD is debated however, the Study to Understand Mortality and Morbidity in COPD (SUMMIT) suggested that ICS are associated with reduced lung function (FEV1) decline, and decreased risk of AECOPD. In contrast, a recent randomised control trial (RCT), the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial, investigated whether FEV1 decline in COPD patients on triple therapy, who withdrew from ICS, differed from those who remained on triple therapy. Results showed no difference in rate of FEV1 decline between the two groups. Whilst well-performed RCTs allow causal effects of drug treatments to be inferred, they include very specific COPD populations and results may not be generalizable to the general COPD population. Observational studies are therefore needed to assess associations in a wider population of COPD patients. Using mixed effects linear regression and Cox-proportional hazard regression we will investigate the association between risk of AECOPD and FEV1 decline in COPD patients on triple therapy and those who withdraw from ICS.
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Investigating the potential side effects of the human papillomavirus vaccine: a novel regression discontinuity analysis using the UK Clinical Practice Research Datalink — Kate Tilling ...
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Investigating the potential side effects of the human papillomavirus vaccine: a novel regression discontinuity analysis using the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-10
Organisations:
Kate Tilling - Chief Investigator - University of Bristol
Theresa Redaniel - Corresponding Applicant - University of Bristol
Kate Tilling - Collaborator - University of Bristol
Ruta Margelyte - Collaborator - University of BristolOutcomes:
Autonomic nervous system (ANS) disorders - Postural orthostatic tachycardia syndrome (POTS) - Post-viral fatigue syndrome /myalgic encephalomyelitis - Premature ovarian failure - Alopecia - Demyelinating diseases - Chronic fatigue syndrome/ myalgic encephalomyelitis - Complex regional pain syndrome (CRPS) - Venous thromboembolism (VTE) - Myasthenia gravis - Dysautonomias - Number of hospitalisations - Neuropathies - Guillain-Barre syndrome - Systemic lupus erythematosus - Thrombocytopenia - Neurogenic bladder and bowel dysfunctions - Number of GP consultations
Description: Technical Summary
Evidence surrounding the safety of HPV vaccines is reassuring despite extensive media attention suggesting otherwise. We will use a regression discontinuity analysis (RDA) to assess the effect of the HPV vaccine on suggested adverse outcomes. RDA is a statistical technique that allows for causal inference when a decision rule (such as being above or below a cut-off value on a continuous measure) is used to assign treatment. It is a quasi-experimental method that (like RCTs) reduces the effect of confounding of unobserved variables. The assumption being that patients lying just either side of the cut-off value are similar, in terms of observed and unobserved characteristics. Focussing on a small window surrounding the cut-off value should result in treatment assignment being the only difference between patients. Our study sample will be comprised of 12-13-year-old girls born in July through October in each year 2000, 2001, 2002, 2003, 2004 and 2005 who have one year of follow up data. We will use date of birth as exposure, comparing girls in the school year that the vaccine is given with those in the school year prior. Outcomes will include side effects such as complex regional pain syndrome and postural orthostatic tachycardia syndrome. RDA is a novel method and it will provide additional insights into the causal effects of HPV vaccine on side effects.
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The utilisation of linaclotide in patients with Irritable Bowel Syndrome predominantly with constipation (IBS-C) in the United Kingdom: a retrospective observational study using the Clinical Practice Research Datalink — Javier Cid ...
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The utilisation of linaclotide in patients with Irritable Bowel Syndrome predominantly with constipation (IBS-C) in the United Kingdom: a retrospective observational study using the Clinical Practice Research Datalink
Datasets:GP data, Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-07
Organisations:
Javier Cid - Chief Investigator - Evidera, Inc
Nafeesa Dhalwani - Corresponding Applicant - Evidera, Inc
Ahunna Ukah - Collaborator - Allergan, Inc
Anna Schultze - Collaborator - Evidera, Inc
Mireia Raluy Callado - Collaborator - Evidera, Inc
Robert Donaldson - Collaborator - Evidera, Inc
Sophie Graham - Collaborator - Evidera, IncOutcomes:
Primary Health Outcomes
- Characteristics of patients prescribed linaclotide at the time of first prescription
- Characteristics of patients by specific sub-groups of interest: paediatric population, elderly population patients with diabetes, hypertension, or cardiovascular disease diagnostic codes, patients with codes for constipation only
- Number and percentage of patients with the potential for linaclotide off-label use as a laxative, in other types of constipation disorders and in paediatric populationSecondary Health Outcomes
- Proportion and characteristics of patients prescribed linaclotide who experience discontinuation and switching to drugs potentially also used by patients with IBS-C moderate to severe
- Duration of linaclotide treatment until discontinuation or switching
- Effect of the indication (IBS-C diagnosis versus other) on the time from initiation to discontinuation or switchingDescription: Technical Summary
Irritable bowel syndrome (IBS) is a chronic, relapsing gastrointestinal condition characterised by abdominal pain, bloating, and changes in bowel habits. Prevalence estimations vary with the diagnostic criteria used, and in the United Kingdom (UK) were estimated between 9.5% and 22%. IBS can be classified according to Rome III criteria on the basis of the stool's characteristics: IBS predominantly with diarrhoea (IBS-D); IBS predominantly with constipation (IBS-C); and IBS with mixed bowel habits (IBS-M), with approximately one third of IBS patients having each type.
The commercialisation of linaclotide (Constella), a guanylate cyclase-C receptor agonist with visceral analgesic and secretory activities, was approved as the first medicine authorised for the symptomatic treatment of moderate-to-severe IBS-C in adults in the European Union (EU).
This study plans to describe the characteristics of patients newly prescribed linaclotide, especially in certain population subgroups for which the use of linaclotide was not sufficiently documented in the clinical programme (including the elderly, males, pregnant or breast-feeding women, and patients with specific comorbidities or taking other medications), and in groups with potential off-label use and patients with potential for abuse/excessive use. Linaclotide treatment patterns will be also described.
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Comparing the effectiveness of COPD treatments in the UK — Ian Douglas ...
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Comparing the effectiveness of COPD treatments in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-14
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amy Zalin - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jennifer Quint - Collaborator - Imperial College London
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
COPD Medication discontinuation
Description: Technical Summary
This study aims to describe prescribing patterns and compare the time to first treatment change amongst people receiving medication for COPD (using time to treatment change as a proxy for treatment effectiveness and tolerability). We will firstly determine all patients with a valid diagnosis of COPD who start treatment for COPD at the time of, or after this diagnosis. We will then describe the different treatments people are receiving (e.g. long acting beta-agonist (LABA), long acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS), ICS/LABA combination). Finally, we will use Cox regression to determine any differences in time to treatment change, between these groups, using the group prescribed a LAMA as the baseline group as based on feasibility work we anticipate this will be the largest group. Treatment change will be defined as either the discontinuation of the initial treatment or the addition of a further COPD treatment. Variables considered for their potential confounding nature will be; age, sex, calendar year, lung function (FEV1, FEV1/FVC ratio), recent COPD exacerbations, body mass index, alcohol consumption, history of cardiovascular disease, type 2 diabetes.
Source - and 13 more projects — click to show
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Retrospective cohort study to understand the natural history and burden of disease of Huntingtonâs disease in the United Kingdom — David Evans ...
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Retrospective cohort study to understand the natural history and burden of disease of Huntingtonâs disease in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-07
Organisations:
David Evans - Chief Investigator - Roche
Hannah Furby - Corresponding Applicant - Roche
Allison Dillon - Collaborator - Genesis Research LLC
Asif Jan - Collaborator - Roche
Thanos Siadimas - Collaborator - RocheOutcomes:
Motor symptoms
⢠Healthcare resource utilization
⢠Time to death after diagnosis and cause of death
⢠Cognitive symptoms
⢠Treatment patterns (pharmacological vs. non-pharmacological)
⢠Psychiatric symptoms
⢠Comorbities and symptomsDescription: Technical Summary
The study aims to describe the natural history, treatment patterns, and healthcare resource utilization (HCRU) of Huntingtonâs Disease (HD) in the United Kingdom (UK). A cohort of patients with HD and a matched non-diseased cohort will be constructed from linked Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES), and mortality (ONS) data. The clinical characteristics, treatments, and procedures in patients with HD at time of diagnosis, motor-symptom onset, and 3 months before death will be characterized using descriptive statistics. The time to death will be estimated for the incident HD and matched non-diseased cohorts stratified by age strata and sex. A standardized mortality ratio will be calculated by gender and age strata in order to compare the mortality risk of the HD cohort to that of the CPRD population. Total HCRU will also be compared between cohorts to describe the burden of HD on the health system. Finally, a general cohort from the linked datasets will be constructed to calculate the incidence of HD over the study period and the point prevalence at the end of each calendar year, overall and stratified by age, sex, and geographical region.
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The impact of not speaking English as a first language on diabetes control and outcomes in primary care — Florence Wedmore ...
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The impact of not speaking English as a first language on diabetes control and outcomes in primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-19
Organisations:
Florence Wedmore - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Florence Wedmore - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Haemoglobin A1c (HbA1c)
- Macrovascular complications of diabetes
- Systolic blood pressure
- Prescription of insulin
- Microvascular complications of diabetesDescription: Technical Summary
The aim of this study is to investigate the effect of not speaking English as a first language on control of, and outcomes from, type 2 diabetes (T2DM) in primary care. It could be postulated that not speaking English as a first language will affect many aspects of a patient's care, though no previous population-level studies have investigated this hypothesis in the UK.
We will use a cohort study design of patients with newly diagnosed T2DM to investigate differences in markers of disease control, time to development of more severe T2DM, as shown by initiation of insulin and rates of developing complications from diabetes (controlling for baseline disease status). The specific outcomes will be HbA1c, blood pressure, and the development of microvascular (diabetic eye disease, nephropathy and neuropathy) and macrovascular complications (peripheral vascular disease, cardiovascular disease or stroke/TIA), and a new insulin requirement. Outcomes will be analysed by linear and logistic regression (for HbA1c and blood pressure) and cox proportional hazards regression (for rates of developing complications and initiation of insulin), controlling for potential confounders. If patients who don't speak English as a first language are shown to have differing outcomes then further research could be aimed at investigating the cause, and targeting interventions to address, this difference.
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AlzheimerÂs disease subtype discovery in electronic health records using cluster analysis — Spiros Denaxas ...
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AlzheimerÂs disease subtype discovery in electronic health records using cluster analysis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-11
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Caroline Dale - Collaborator - University College London ( UCL )
Daniel Alexander - Collaborator - University College London ( UCL )
Kenan Direk - Collaborator - University College London ( UCL )
Nonie Alexander - Collaborator - University College London ( UCL )Outcomes:
 AlzheimerÂs disease subtypes
 Predicting outcome in AlzheimerÂs disease
 AlzheimerÂs disease progression
 Improved AlzheimerÂs detection
 AlzheimerÂs disease phenotyping
 Inform personalised treatmentDescription: Technical Summary
Dementia will affect 75 million people globally by 2030. AD is the most common form of dementia, diagnosis is challenging and currently no cure exists. Difficulty in meeting the needs of these patients stem from the heterogeneous nature of the disorder. Each patient can have a wide variety of symptoms thus identifying AD and targeting treatments becomes more complex. In this study, we will use clustering analysis to identify AD subtypes in electronic health records. Clustering is an exploratory approach that identifies subtypes of a disease through finding groups of patients more similar to those in the group than those not, based on a multitude of variables.
This technique has been used to identify AD subtypes in smaller studies using neuropsychological and imaging data. However, cluster analysis of a larger patient database, a relatively unbiased population of EHR, could lead to the improved identification and characterisation of AD phenotypes which could create better disease progression models. As EHR contains longitudinal data we will also create trajectory models that will find more clinically relevant disease subtypes. Using the subtypes found we hope to identify undiagnosed AD patients within an unspecified dementia cohort through comparing the progression of patients with AD.
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Use of primary care and hospital services in children and young people aged less than 25 years in England; descriptive study — Sonia Saxena ...
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Use of primary care and hospital services in children and young people aged less than 25 years in England; descriptive study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-10
Organisations:
Sonia Saxena - Chief Investigator - Imperial College London
Kimberley Foley - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Dougal Hargreaves - Collaborator - Imperial College London
Geva Greenfield - Collaborator - Imperial College London
Hanna Creese - Collaborator - Imperial College London
Mitch Blair - Collaborator - Imperial College LondonOutcomes:
Primary outcome
- Rates of GP consultations per child per year
Secondary outcomes
- Rates of emergency department visits per child per year
- Rates of elective hospital admissions per child per year
- Rates of unplanned hospital admissions per child per year
- Rates of prescriptions per child per year
- Rates of outpatient hospital attendances per child per yearDescription: Technical Summary
Children and young people are high impact users of health services and rising visits to GPs, emergency departments and hospital admissions in the United Kingdom (UK) placing the National Health Service (NHS) under increasing pressure.
Little is known about how consultation rates in primary care and hospital services have changed since major reforms in primary care that may have affected children and young peopleâs access to GPs or which children and young people are most likely to use primary care and hospital services. We aim to describe how childrenâs GP consulting patterns and use of urgent and planned hospital care has evolved in the UK over the last 10 years from 2007 to the latest data available. We will examine trends in rates of GP consultation, prescribing, outpatient attendances, emergency department visits, elective and unplanned hospital admissions in children and young people aged less than 25 for calendar years from 2007 to the latest data available and how these trends have been impacted by the COVID-19 crisis. We will stratify the rates calculated above by developmental age bands, ethnic group and groups living in different areas of deprivation. The findings will report on the current state of healthcare use by children and young people under 25 and may be useful to inform resource allocation within the NHS to meet needs of children and families in England.
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Prevalence, incidence, and natural history of gastroparesis in the United Kingdom: real world evidence from the Clinical Practice Research Datalink — Paul Dolin ...
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Prevalence, incidence, and natural history of gastroparesis in the United Kingdom: real world evidence from the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-21
Organisations:
Paul Dolin - Chief Investigator - Takeda Europe Ltd
Yizhou (James) Ye - Corresponding Applicant - Not from an Organisation
Dimitri Bennett - Collaborator - Takeda TGRD - USA
Sudhakar Manne - Collaborator - Takeda TGRD - USAOutcomes:
Prevalence
- Incidence
- Disease managementDescription: Technical Summary
We aim to evaluate gastroparesis epidemiology including both prevalence and incidence and natural history within the UK CPRD using a retrospective cohort study. The study population will include all patients who were registered at any time during 2000 to 2016 with a "up to research standard" general practice (GP) in the CPRD linkage subset. Incident cases of gastroparesis are defined as newly diagnosed gastroparesis, while prevalent cases include both previously and newly diagnosed patients. At least 1 year of gastroparesis free enrolment is required to distinguish prevalent and incident cases. Prevalence and incidence will be assessed annually. The crude prevalence and incidence will be stratified based on age group and sex and standardized using the age and/or sex-specific UK population estimate in mid-2016 as the reference population. Descriptive statistics for demographics and clinical characteristics as well as the medical practice to manage gastroparesis will be summarized and described for gastroparesis patients.
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Is herpes zoster associated with risk of incident dementia? A cohort study using the Clinical Practice Research Datalink. — Charlotte Warren...
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Is herpes zoster associated with risk of incident dementia? A cohort study using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-27
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
James Borgas-Howard - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Judith Breuer - Collaborator - University College London ( UCL )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Suhail Ismail Shiekh - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcome: Incident dementia (all types)
- Secondary outcome: Incident dementia subtypes
- Secondary outcome: New onset symptoms of memory lossDescription: Technical Summary
The global burden of dementia is increasing as populations age. While some lifestyle, health and social risk factors for dementia are well-recognised, modifiable factors account for only one third of dementia cases. Recent evidence shows that chronic reactivating neurotropic herpesviruses can trigger acute cardiovascular events such as stroke, which in turn increase dementia risk. Potential mechanisms linking viruses such as herpes zoster (shingles) and stroke include systemic inflammation, and/ or vasculopathy, in which viral infection of cerebral arteries leads to pathological vascular remodelling. National data from Taiwan suggests that ophthalmic zoster is associated with an increase in dementia risk at five years, but there is no comparable published data from the UK.
Here we aim to investigate the association between herpes zoster and incident dementia in a large powerful population cohort using electronic health records data. We will use propensity scores to match patients exposed and unexposed to herpes zoster to improve baseline comparability. We will compare hazard ratios for incident dementia among adults aged >/=40 years with and without zoster exposure using Cox regression. We will carry out a range of sensitivity analyses to check the robustness of our models. This will inform future research around zoster vaccine policy.
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What influence does obesity have on healthcare utilisation cost for patients with and without cardiovascular diseases? — Christiane L Haase ...
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What influence does obesity have on healthcare utilisation cost for patients with and without cardiovascular diseases?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-14
Organisations:
Christiane L Haase - Chief Investigator - Novo Nordisk
Anne Helene Olsen - Corresponding Applicant - Novo Nordisk
Adeeb Tawseef - Collaborator - IQVIA
Anne Helene Olsen - Collaborator - Novo Nordisk
Niels Væver Hartvig - Collaborator - Novo Nordisk
Rikke Baastrup Nordsborg - Collaborator - Novo NordiskOutcomes:
Healthcare Cost Utilization
Description: Technical Summary
The cohort consists of patients registered in the CPRD who have a current registration date prior to 01.01.2011 and acceptable data as defined by CPRD. Each patient is followed from an individual baseline (latest date of BMI measurement between 01.01.2011 and 31.12.2012) until end of follow-up (minimum of death date, transfer out date or 31.07.2017). Patients below 18 years of age at baseline are excluded. For patients with no BMI measurement record the baseline date will be 31.12.21012. Rates of the three endpoints are:
- Compare rates of GP contacts between patients at different BMI groups and by CVD status.
- Compare rates of prescriptions between patients at different BMI groups and by CVD status.
- Compare rates of hospital admissions between patients at different BMI groups and by CVD status.The rates for different BMI groups are compared within groups of cardiovascular disease using a negative binomial model. Sensitivity analyses concerning the group of patients without a registered BMI will be performed.
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Use of inhaled corticosteroids and risk of pneumonia in asthma — Jennifer Quint ...
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Use of inhaled corticosteroids and risk of pneumonia in asthma
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-14
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Christer Janson - Collaborator - Imperial College London
Debbie Jarvis - Collaborator - Imperial College LondonOutcomes:
Pneumonia hospitalisation
 MortalityDescription: Technical Summary
We will identify a cohort of patients with current asthma (using validated Read codes) and a random sample of the general population that do not have asthma, between 2006 and 2017. Patients will be aged 5 to 55 years, and will not have chronic obstructive pulmonary disease (similar disease that also uses same treatments). We will use a Poisson regression model to estimate the association between asthma, inhaled corticosteroids (ICS) and first hospitalised community acquired pneumonia (CAP). The exposure will be categorised according to asthma or not, and ICS dose (this will help to identify a dose response if there is one). We will adjust for multiple potential confounders (including age, gender, smoking, body mass index, use of immunosuppressives and diabetes mellitus). We will also carry out additional analyses to compare patients on the same ICS dose but with differing asthma severity (defined by their additional asthma maintenance medications), and compare patients on three commonly used different ICS drugs (beclometasone, fluticasone and budesonide). As the outcome is an event that occurs in secondary care we will only include patients with linked HES data.
Source -
The cumulative incidence of seizures during 21 days after new use of oral antibiotics - a cohort study — Susan Jick ...
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The cumulative incidence of seizures during 21 days after new use of oral antibiotics - a cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-07
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Marlene Rauch - Corresponding Applicant - University of Basel
Bojana Vulin - Collaborator - University of Basel
Charlotte Holze - Collaborator - University of Basel
Christoph Meier - Collaborator - University of Basel
Cornelia Schneider - Collaborator - University of Basel
Michael Bodmer - Collaborator - University of Basel
Raoul Sutter - Collaborator - University Hospital Basel
Sarah Tschudin Sutter - Collaborator - University Hospital Basel
Stephan Ruegg - Collaborator - University of Basel
Theresa Burkard - Collaborator - University of BaselOutcomes:
Incident seizures
Description: Technical Summary
We will estimate the cumulative incidence of epileptic seizures in patients aged 1 year or older during the 21-day period after recording of a new oral antibiotic prescription (beta-lactam antibiotics, quinolones, macrolides/lincosamides, tetracyclines, or sulfonamides/ trimethoprim) in the patient record. We will assess the cumulative incidence of epileptic seizures in a matched comparison group of patients not prescribed antibiotics. We will divide the study period (January 1, 1997 and December 31, 2016) into twenty 1-year study blocks, and each patient who was exposed in a block will be matched 1:1 to a patient who was unexposed within the same block on general practice, age, sex, calendar time, and recorded history on the database. We will estimate cumulative incidences of epileptic seizures stratified by age, estimated glomerular filtration rate, underlying type of infection, body mass index, alcohol consumption, smoking status, drug dependence, metabolic disorders, brain disorders, and prescribed antibiotic type and dose. We will also calculate risk ratios of epileptic seizures by dividing the cumulative incidence in exposed patients by the cumulative incidence in the matched non-exposed comparison group.
Source -
Health benefits of sustained weight loss in people with overweight or obesity — Anne Helene Olsen ...
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Health benefits of sustained weight loss in people with overweight or obesity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-14
Organisations:
Anne Helene Olsen - Chief Investigator - Novo Nordisk
Anne Helene Olsen - Corresponding Applicant - Novo Nordisk
Altynai Satylganova - Collaborator - Novo Nordisk
Christiane L Haase - Collaborator - Novo Nordisk
Phil McEwan - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Sandra Lopes - Collaborator - Novo Nordisk
Volker Schnecke - Collaborator - Novo NordiskOutcomes:
Type 2 diabetes
- Dyslipidaemia
- Transient ischemic attack
- Asthma
- Atrial fibrillation
- Stroke
- Sleep apnoea
- Osteoarthritis
- Hypertension
- Atherosclerosis
- Heart failure
- Chronic kidney disease
- Unstable angina
- Myocardial infarction
- Hip/knee replacement
- Cardiovascular (CV) deathDescription: Technical Summary
The aim of this study is to assess the risk of various disease outcomes in persons with excess body weight and to evaluate the effect of a moderate weight loss. We will compare a cohort of subjects with sustained weight loss, i.e., 10% weight loss during one year followed by stable weight during the following year, with a control cohort of subjects with a 2-year stable weight period. We will use Cox proportional hazard models to quantify the relative risk reduction due to the weight loss on a number of obesity comorbidities. In the Cox proportional hazard models, age will be the underlying time scale. Follow-up will be censored at the first outcome diagnosis, death, transfer-out date, or study end, whichever occurs first. In particular, we will look at:
- primarily weight-related outcomes (sleep apnoea, osteoarthritis, asthma)
- cardiovascular risk factors and cardio-metabolic diseases (hypertension, type 2 diabetes, heart failure and chronic kidney disease)
- Hard endpoints (myocardial infarction, stroke, and death)
- Hip/knee replacementAll applicable endpoints will also be included as comorbidities if diagnosed before start of follow-up in order to adjust for these known risk factors in the models.
Source -
Prescribing of high dose oral ibuprofen (1800mg/day or more) in UK primary care — Preeti Datta...
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Prescribing of high dose oral ibuprofen (1800mg/day or more) in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-06-07
Organisations:
Preeti Datta-Nemdharry - Chief Investigator - MHRA
Preeti Datta-Nemdharry - Corresponding Applicant - MHRAOutcomes:
NA as it is a drug usage study
Description: Technical Summary
The main objective of the study is to evaluate the prescribing of high dose ibuprofen (1800mg or more) using CPRD GOLD. The study will also look at prescribing of high dose ibuprofen in patients with pre-existing hypertension and duration of prescribing.
This is a descriptive study, using a retrospective cohort design, of all patients in CPRD, regardless of age or indication, from 01/01/2013 to 31/12/2017 who have been prescribed high dose ibuprofen (1800mg/day or more).
Absolute numbers and proportions of patients who were prescribed high dose ibuprofen will be calculated. The prevalence of patients with a prescription of high dose ibuprofen will also be presented. In addition, absolute numbers and proportions of prescriptions issued will be reported. The numbers and proportions patients with pre-existing hypertension, recorded within 3 months of an ibuprofen prescription, will be analysed. Results will be presented per calendar year and for all the years together.
The duration of high dose ibuprofen treatment will be estimated from the prescribing information in CPRD which includes quantity of tablets and daily dose. Gaps of 91 days between prescriptions will be assumed to be breaks in treatment. Descriptive statistics i.e. mean, median, interquartile range, range, standard deviation will be calculated for duration of use.
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COPD, Asthma and Depression — West London NHS Trust...
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COPD, Asthma and Depression
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-18
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Chronic obstructive pulmonary disease (COPD), Asthma, Depression. Academic
Source -
NHS Pathways for blood draw device — Imperial College Health Partners...
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NHS Pathways for blood draw device
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: Jun-18
Opt Outs: no information provided./p>
Organisations: Imperial College Health Partners
Description: All. Academic
Source
2018 - 05
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Seasonal Influenza Vaccine Effectiveness and Safety in Asthma — Colin Simpson ...
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Seasonal Influenza Vaccine Effectiveness and Safety in Asthma
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-21
Organisations:
Colin Simpson - Chief Investigator - University of Edinburgh
Eleftheria Vasileiou - Corresponding Applicant - University of Edinburgh
Aziz Sheikh - Collaborator - University of Edinburgh
Chris Robertson - Collaborator - University Of Strathclyde
Christopher Butler - Collaborator - University of OxfordOutcomes:
Asthma exacerbations
Hospital admission due to influenza/pneumonia Antibiotic prescription related to a respiratory infection or otitis media
Influenza or influenza-like illness
Death
Adverse events related to influenza vaccines
Primary care consultation due to influenza/pneumonia
Acute respiratory infection or otitis media or any other respiratory infectionDescription: Technical Summary
Influenza causes considerable morbidity and mortality among individuals with chronic underlying conditions such as asthma. In the UK current policy recommends all individuals with asthma to be immunised with the influenza vaccine. However, the vaccine uptake rates remain suboptimal in asthma partially due lack of strong evidence on the vaccine effectiveness and safety concerns particularly for the new childhood live attenuated vaccine from parents and healthcare providers. The aim of this project is to provide national estimates of the effectiveness and safety of influenza vaccine amongst people with asthma. A longitudinal retrospective cohort study will be undertaken to estimate the vaccine effectiveness in asthma against clinical outcomes such asthma influenza illness, asthma exacerbations and mortality. A Cox proportional hazards model will be used to estimate the hazard ratios (HRs) of all clinical outcomes adjusted for all patient characteristics. The vaccine effectiveness will be estimated from the HRs for each clinical outcome for seasons 2000-2017. A self-controlled case series study design will assess the safety of the live vaccine in young children with asthma against any vaccine-induced adverse events such as asthma attacks for seasons 2013-2017. Only vaccinated cases will be used to estimate the relative risk of adverse events.
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Population characteristics and treatment patterns by renal function status in type II diabetes: A population-based cohort study — Anthony Louder ...
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Population characteristics and treatment patterns by renal function status in type II diabetes: A population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-22
Organisations:
Anthony Louder - Chief Investigator - Aetion, Inc
Anthony Louder - Corresponding Applicant - Aetion, Inc
Alain Gay - Collaborator - Bayer AG
Dana Teltsch - Collaborator - Aetion, Inc
David Vizcaya - Collaborator - Bayer AG
Julie Broughton - Collaborator - Bayer AG
Michael Blankenburg - Collaborator - Bayer AGOutcomes:
eGFR/ACR Screening (Renal Function)
 Medication Treatment Patterns (RAAS Therapies)Description: Technical Summary
The purpose of this study is to assess the incidence and prevalence of type 2 diabetes (T2DM) in the UK and to describe the current standard of care in terms of screening and treatment, specifically treatment via the renin-angiotensin-aldosterone system (RAAS) route (ACE-Inhibitors [ACE-Is], angiotensin receptor blockers [ARBs] and other therapies that impact the system). Treatment patterns will be assessed in terms of time to treatment, adherence and persistence. Furthermore, the albuminin creatinine ratio (ACR) and/or estimated glomular filtration rate (eGFR) laboratory results will be used to identify the CKD stage so the results can be further stratified into subgroups based on clinical guidelines. Clinical trials are evaluating a new generation of steroidal mineralocorticoid receptor antagonists (sMRAs) which could be a new means to address the inflammation which can underlie the disease mechanism. The results of this study can be used to identify groups of individuals that could benefit from treatment by this proposed new strategy of treating CKD.
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An investigation into the effect of quality of antenatal care on the risk of stillbirths in the UK — Amanda Clery ...
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An investigation into the effect of quality of antenatal care on the risk of stillbirths in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-16
Organisations:
Amanda Clery - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Amanda Clery - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Stillbirth
- Livebirth
- Quality of antenatal careDescription: Technical Summary
NHS England have the aim to half the rates of stillbirths by 2030, but reductions in the rates have slowed. Current interventions have been based on care that raises awareness of biological factors that increase the risk of stillbirth. Yet, there is little research into who is actually receiving this care and the social risk factors of stillbirth. Therefore, this study will use the Pregnancy Register at the Clinical Practice Research Datalink, to investigate the association between quality of antenatal care and the risk of stillbirth. Descriptive analysis will identify the characteristics of the study population and the proportion who have experienced a stillbirth. Multivariable logistic regression will then be used to determine the odds of stillbirth in those who do and do not receive good quality antenatal care (according to NICE guidelines). This analysis will also control for numerous potential confounders. Subgroup analyses will then be conducted to determine the characteristics of those who do and do not receive good quality care to identify high-risk groups. The identification of these factors and their effects on stillbirth and high-risk groups will guide further research into designing the most appropriate interventions to resume the decline in the UKs stillbirth rates.
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Evaluating the NHS Diabetes Prevention Programme (NHS DPP): Assessing whether the NHS DPP is more effective than usual care in reducing conversion of nondiabetic hyperglycaemia to diabetes, eventually reducing diabetes prevalence in England — Evangelos Kontopantelis ...
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Evaluating the NHS Diabetes Prevention Programme (NHS DPP): Assessing whether the NHS DPP is more effective than usual care in reducing conversion of nondiabetic hyperglycaemia to diabetes, eventually reducing diabetes prevalence in England
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Non-standard
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-31
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Rathi Ravindrarajah - Corresponding Applicant - University of Manchester
David Reeves - Collaborator - University of Manchester
Simon Heller - Collaborator - University of SheffieldOutcomes:
 Diabetes
- Cardiovascular and diabetes related mortality
- At Risk of Diabetes
- All-Cause Mortality
- HospitalisationDescription: Technical Summary
Background: The NHS Diabetes Prevention Programme (NHS DPP) is a programme to deliver evidence-based behavioural change intervention to the patients with impaired fasting glucose (IFG) who are at risk of developing type 2 diabetes, this condition is known as non-diabetic hyperglycaemia (NDH), to encourage behaviour change and reduce risk of diabetes.
Aim: To evaluate the effectiveness of the NHS DPP by analysis of routine data, to find out whether the NHS DPP leads to the reduction of the prevalence of diabetes and other outcomes, using suitable comparators without access to the NHS DPP.
Methods: Data from all CPRD practices participating in the NHS DPP will be used. The conversion rate from nondiabetic hyperglycaemia to Type 2 Diabetes will be compared between the pre-DPP and post-DPP periods within participating practices. A matched cohort study will be used to compare the rates of conversion to diabetes within 3 years between these time periods. Focusing on the post-intervention period, we will also compare within-practices between matched patients referred versus not referred, and also between practices referring to the scheme versus those that are not referring. These analyses assume that reliable information on dates of referral will be available for practices and patients. If that proves to be not the case, a third design will be used that compares practices within areas where the programme is available, to practices in areas where it is not.
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Long-term relative effectiveness of monotherapy antihypertensive drugs in patients newly diagnosed with hypertension. A cohort study in the UK Clinical Practice Research Datalink (CPRD) — Caroline Foch ...
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Long-term relative effectiveness of monotherapy antihypertensive drugs in patients newly diagnosed with hypertension. A cohort study in the UK Clinical Practice Research Datalink (CPRD)
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-21
Organisations:
Caroline Foch - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Caroline Foch - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Arthur Allignol - Collaborator - Merck Healthcare KGaA (Merck Group)
Emmanuelle Boutmy - Collaborator - Merck Healthcare KGaA (Merck Group)
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)
Thilo Hohenberger - Collaborator - Merck Healthcare KGaA (Merck Group)Outcomes:
All-cause mortality (Primary outcome)
Cardiovascular mortality
Cardiovascular event
- Myocardial infarction
- Arrhythmia
- Angina episode
Cerebrovascular event
- Stroke
- Haemorrhagic stroke
- Ischaemic stroke
Discontinuation of index treatmentDescription: Technical Summary
Primary objective is to compare the all-cause mortality in newly hypertensive patients initiating a Beta-blocker in monotherapy, compared to angiotensin-converting enzyme inhibitor (ACE-I) monotherapy, compared to angiotensin II receptor blockers monotherapy, compared to calcium channel blockers (CCB) monotherapy, compared to diuretic monotherapy. Secondary outcomes are cardiovascular mortality, cardiovascular events (myocardial infarction, angina, arrhythmia), cerebrovascular events (stroke) and discontinuation of index treatment.
Newly hypertensive patients initiating a monotherapy with an antihypertensive drug between 2000 and 2017 will be allocated to one of the cohort: Beta-blocker, ACE-I, ARB, CCB, or diuretic. Only patients with a diagnosis of hypertension for the first time ever within the 6 months before the first antihypertensive prescription date (index date) will be included. Patients will be followed until: addition of another antihypertensive drug, discontinuation of the index antihypertensive class, occurrence of an outcome of interest (depending on the analysis: death, cardiovascular or cerebrovascular events, treatment discontinuation), patient death, last data collection date in the CRPD, or end of study period, which ever came first.
Differences in all-cause mortality between cohorts will be assessed using Cox proportional hazards models, and differences in the secondary outcomes using Cox proportional hazards models and Fine and Gray's proportional subdistribution hazards models.
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Causes of death in patients with gout and impact of urate lowering therapy: a population based cohort study — Rebecca Whittle ...
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Causes of death in patients with gout and impact of urate lowering therapy: a population based cohort study
Datasets:GP data, ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-14
Organisations:
Rebecca Whittle - Chief Investigator - Keele University
Rebecca Whittle - Corresponding Applicant - Keele University
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Christian Mallen - Collaborator - Keele University
Edward Roddy - Collaborator - Not from an Organisation
John Belcher - Collaborator - Keele University
Lorna Clarson - Collaborator - Not from an Organisation
Trishna Rathod-Mistry - Collaborator - Keele UniversityOutcomes:
Cause of death:
o Infection
o Cardiovascular disease
o Dementia
o Diabetes
o Neoplasm
o Renal
o All other causesDescription: Technical Summary
Gout is the most prevalent type of inflammatory arthritis in the UK, affecting 2.5% of adults and is responsible for premature mortality. Evidence describing causes of death among gout patients remains limited. Around 35% of patients with gout are prescribed urate lowering therapy (ULT). Whilst ULT improves outcomes in these patientsÂ, its influence on cause-specific mortality remains unknown.
This project will quantify the risk of 1) all-cause and 2) cause-specific mortality among gout patients compared with the general population and 3) investigate the effect of ULT exposure on the risk mortality among gout patients.
For aim 1 and 2, we will use a retrospective matched cohort, identifying incident gout patients matched to four gout-free patients on gender, age, general practice and follow-up time. Risk of all-cause and cause-specific mortality will be compared between cases and controls using Cox regression models, obtaining hazard ratios and 95% confidence intervals. For aim 3, we will extract information on ULT exposure from the gout patients only. We will compare the risk of all-cause and cause-specific mortality between those prescribed at least 6 months ULT within a 1 and 3 year landmark exposure window following gout diagnosis, and those not prescribed ULT during that period.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 6 - Replication of "Glucagon-like peptide-1 analogues and risk of breast cancer in women with type 2 diabetes: population based cohort study using the UK CPRD" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 6 - Replication of "Glucagon-like peptide-1 analogues and risk of breast cancer in women with type 2 diabetes: population based cohort study using the UK CPRD"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-29
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Use of GLP-1 analogues compared with use of DPP-4 inhibitors
Incident breast cancerDescription: Technical Summary
This objective of this protocol is to replicate the study: "Glucagon-like peptide-1 analogues and risk of breast cancer in women with type 2 diabetes: population based cohort study using the UK Clinical Practice Research Datalink" by Hicks et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Hicks paper compares increased risk of incident breast cancer between female type-2 diabetes users of glucagon-like-peptide (GLP-1) and dipeptidylpeptidase-4 (DPP-4) from 2007 to 2015. We will focus on replicating the hazard ratio comparing the increased risk of incident breast cancer between GLP-1 and DPP-4 users over this period. The reference group was considered users of DPP-4 inhibitors. One year after entering the cohort, study participants were followed until their first breast cancer diagnosis. Descriptive statistics were calculated for both exposure groups, including incidence of breast cancer with 95% confidence intervals. Risk of incident breast cancer will be compared using a hazard ratio calculated from a time dependent Cox proportional hazards model. The model adjusted for a list of potential confounders, including year of cohort entry, age, body mass index, smoking status, alcohol-related disorders, haemoglobin A1c, duration of treated diabetes, and presence of microvascular complications of diabetes.
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The Association of oral bisphosphonate use with mortality risk following a major osteoporotic fracture in the UK — Frank de Vries ...
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The Association of oral bisphosphonate use with mortality risk following a major osteoporotic fracture in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-21
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Joop van den Bergh - Collaborator - Maastricht University
Piet Geusens - Collaborator - Maastricht University
Shahab Abtahi - Collaborator - Utrecht University
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
All-cause mortality
Description: Technical Summary
Objectives: To examine the association of oral bisphosphonate treatment on all-cause mortality after any hip and other major osteoporotic fractures.
Design: Cohort study using the Clinical Practice Research Datalink (CPRD).
Participants: Men and women aged 50 years and over who sustained a first recording of a hip, or non-hip major osteoporotic fracture following 2005 will be eligible for inclusion with prior fractures since 1994 as potential confounders. Date of fracture will define the index date (start of follow-up).
Exposure: The primary drug exposure will be the initiation of oral bisphosphonate (alendronate or risedronate vs. etidronate or no) medications. Patient exposure time will be classified time dependently following fracture (index) date.
Primary outcome: All-cause mortality.
Statistical analyses: Cox Proportional Hazard (SAS PHREG procedure) to assess the risk of all-cause mortality associated with the current use of oral bisphosphonate medications following first hip, or non-hip major osteoporotic fracture will be conducted. Never use will be the comparator groups in all analyses, and separate models will be run based on fracture site. All primary analyses will be further stratified by gender. Secondary analyses will stratify current use by type of bisphosphonate, and follow-up time. All models will be adjusted for relevant confounders.
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Use of non-steroidal anti-inflammatory drugs and risk of acute myocardial infarction in patients undergone total hip or knee replacement surgery: a population-based cohort study — Frank de Vries ...
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Use of non-steroidal anti-inflammatory drugs and risk of acute myocardial infarction in patients undergone total hip or knee replacement surgery: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-22
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Arief Lalmohamed - Collaborator - University Medical Centre Utrecht
Bart JF van den Bemt - Collaborator - Sint Maartenskliniek
Karin Lancee - Collaborator - Utrecht UniversityOutcomes:
Our primary outcome of interest will be an AMI. All patients will be followed from the index date until death, transfer out of the practice, THR / TKR revision, the end of data collection, or an AMI. AMI will be classified using CPRD READ codes (see Appendix II). For our secondary outcome of interest, we will follow patients up until all-cause mortality.
Description: Technical Summary
The objective is to compare the risk of acute myocardial infarction between different NSAIDs in patients with concomitant aspirin use. Within the CPRD, all adult patients with a primary total hip / knee replacement surgery will be selected. To eliminate distortions from the in hospital period, the first 6 postoperative months will be excluded from the analysis. The exposure of interest is use of different types of NSAID in patients concomitantly taking aspirin. Exposure will be assessed in a time-dependent manner. Adjusted Cox regression models will be used to derive relative risks for the association between NSAID plus aspirin use and the risk of acute myocardial infarction and all-cause mortality.
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Using CPRD to describe the current management of heart failure in England and model risk trajectories to improve shared decision-making — Alex Bottle ...
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Using CPRD to describe the current management of heart failure in England and model risk trajectories to improve shared decision-making
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-31
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Alex Bottle - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Martin Cowie - Collaborator - King's College London (KCL)
Paul Aylin - Collaborator - Imperial College LondonOutcomes:
Death (primary outcome)
- Hospitalisation (secondary outcome)Description: Technical Summary
Heart failure (HF) is common, serious and growing in prevalence but can be difficult to diagnose and manage in primary care. Identifying those patients who are at highest risk of poor outcomes such as hospitalisation and death would help doctors and patients make better decisions around management, but it is challenging. Existing risk models have been developed on highly selected cohorts in clinical trials and have other limitations that prevent their widespread use. We propose to use CPRD to describe the management of HF and NHS resource use during two periods, ten years apart, and to model how patients' risk of death changes over time from diagnosis and from first HF admission. Methods will include time-to-event, trajectory and, if it proves feasible, multistate models. Our aim is not to produce the definitive HF risk stratification model, but instead to provide usable information on risk trajectories for shared decision-making by clinicians and patients.
Source - and 25 more projects — click to show
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Real World Evidence Study to Support Project Obesity: Determine co-diseases scenarios among Overweight and Obese patients. Assessment of metabolic profiles and economic burden of these different scenarios — Caroline Amand ...
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Real World Evidence Study to Support Project Obesity: Determine co-diseases scenarios among Overweight and Obese patients. Assessment of metabolic profiles and economic burden of these different scenarios
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-14
Organisations:
Caroline Amand - Chief Investigator - Sanofi UK
Caroline Amand - Corresponding Applicant - Sanofi UK
Alexandre Civet - Collaborator - Quinten S.A.S.
Lilia Ben-Debba - Collaborator - SANOFI
Nicola Clavel - Collaborator - Quinten S.A.S.
Sébastien Tourlet - Collaborator - Quinten S.A.S.Outcomes:
Comorbidities
- Treatment patterns
- Primary and secondary care utilisation
- Metabolic profiles through LAB
- Primary and secondary care costsDescription: Technical Summary
Objectives: The aim of this study is to use data from the Clinical Practice Research Datalink to identify and characterise overweight and obese patients by assessing scenarios of comorbidities and their impact on disease burden (using the metabolic profiles*) and on the economic burden using Health care resource utilization.
Methods: Retrospective overweight and obese cohorts will be derived. Cohorts will be defined using BMI values and diagnosis codes occurred between January 2014 and December 2015. Patients will be defined as Obese if BMI >/=30 kg/m2 as Overweight if BMI inside the range 25-29.9 kg/m2. Index date will be defined as the first status of Obese or overweight recorded during this period. Baseline period will be defined by 12-month pre-index date and follow-up period by 12 months after index date. Continuous enrolment of 1 year over baseline and follow-up will be required to be eligible for inclusion as a selected index date. Women with at least one record of pregnancy over baseline or follow-up will be excluded.
Analysis: Descriptive analysis will be conducted. Scenarios of comorbidities, Demographics, Treatment patterns, metabolic profiles will be described at baseline. Health care utilizations will be described during the follow-up period. All these parameters will be described in overweight and obese classes and in different scenarios of comorbidities considerate as interest for the research.
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The risk of community-acquired pneumonia in children using proton pump inhibitors or histamine-2 receptor antagonists: a population-based cohort study in the United Kingdom — Frank de Vries ...
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The risk of community-acquired pneumonia in children using proton pump inhibitors or histamine-2 receptor antagonists: a population-based cohort study in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-01
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Edward Dompeling - Collaborator - Maastricht University Medical Centre
Ewoudt van de Garde - Collaborator - Utrecht University
Jan Coremans - Collaborator - Maastricht University Medical Centre
Johanna Driessen - Collaborator - Utrecht University
Linda van der Sande - Collaborator - Maastricht University Medical Centre
Michiel Bannier - Collaborator - Maastricht University Medical Centre
Quirijn Jöbsis - Collaborator - Maastricht University Medical CentreOutcomes:
Community acquired pneumonia.
 Hospitalization for community-acquired pneumonia.
 Mortality related to community-acquired pneumonia.Description: Technical Summary
The study objective is to evaluate the risk of developing a community-acquired pneumonia in children using proton pump inhibitors (PPIs) and/or histamine-2 receptor agonists (H2RAs). Within the CPRD, all patients aged <18 years with at least one prescription of PPI or H2RA will be selected. The exposure of interest is occurrence of community acquired pneumonia. Exposure will be assessed in a time-dependent manner; with groups distinguishing between current, recent, past and distant past use. Cox proportional hazard models will be used to derive hazard ratios for the association between use of acid suppressants and the risk of developing a community-acquired pneumonia.
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Trends in acute exacerbation and related hospitalization among COPD patients in the UK (2005-2013) — Frank de Vries ...
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Trends in acute exacerbation and related hospitalization among COPD patients in the UK (2005-2013)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-20
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Frits Franssen - Collaborator - CIRO
Johanna Driessen - Collaborator - Utrecht University
Miel (Emiel) Wouters - Collaborator - CIRO
Olorunfemi Oshagbemi - Collaborator - Utrecht University
Rachel Jordan - Collaborator - University of Birmingham
Spencer Keene - Collaborator - Utrecht UniversityOutcomes:
Acute exacerbations of COPD
COPD HospitalisationDescription: Technical Summary
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide, causing approximately 3.2 million deaths annually. The disease is characterised by the presence of persistent airflow limitation, resulting primarily from proximal, peripheral airway and lung parenchyma obliteration. It is projected that by the year 2030 COPD will be the third highest cause of death globally. While smoking remains the major risk factor for the development of COPD, other factors include genetics and lifestyle. In the UK, mortality has increased from 2004-2012 while incidence decreased and then remained stable over the same period. There are over a million bed days and 140,000 hospital admissions each year in the UK due to COPD. A considerable amount of the burden from COPD is due to acute exacerbations of COPD (AECOPD), defined as short periods of increased cough, dyspnoea, and sputum production. Understanding trends in exacerbations and related hospitalization can help redirect healthcare policies and interventions to subgroups most affected by COPD, allow comparison between countries to aid healthcare planning, predict future healthcare challenges, and provide a basis for improving management in the future. As such it's important to understand the trends in acute exacerbation of COPD and hospitalization/A&E visits for COPD.
We will select all patients aged more than 40 years with a read code diagnosis of COPD within the UK general practice. The date of the first COPD diagnosis will be the index date. The study will be from 1st January 2005 until December 2013, corresponding to the period since the introduction of the Quality and Outcomes Framework (QOF). We will exclude all patients with a history of asthma from the study. Patients will be followed from the index date up to the date of death, end of data collection, or end of study period, whichever comes first. For all patients at risk of the outcome of interest, the incidence rate will be the sum of all events per year divided by the total person-time at risk for each calendar year. We will stratify the incidence rates by age and gender. All analysis will be carried out using SAS 9.4.
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Determinants associated with treatment modification in the first year of treatment in patients with type 2 diabetes mellitus in the United Kingdom, before and after implementation of the new guideline: a retrospective cohort study — Frank de Vries ...
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Determinants associated with treatment modification in the first year of treatment in patients with type 2 diabetes mellitus in the United Kingdom, before and after implementation of the new guideline: a retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-31
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andre Krings - Collaborator - Atrium MC
Andrea Burden - Collaborator - ETH Zurich
Coen Stehouwer - Collaborator - Maastricht University
Johanna Driessen - Collaborator - Utrecht University
Judith van Dalem - Collaborator - Utrecht University
Martijn Brouwers - Collaborator - Maastricht University
Olaf Klungel - Collaborator - Utrecht UniversityOutcomes:
Second-line antidiabetic prescribing before and after implementation of the new NICE guideline
Adherence to guidelinesDescription: Technical Summary
This study's primary objective is to identify determinants associated with prescribing of different second-line therapies in patients with T2DM before and after implementation of the new NICE (National Institute for Health and Care Excellence) guideline. All new users of metformin only and aged 18+ will be followed until they receive a prescription for a glucose-lowering agent other than metformin. We will investigate patient and treatment related determinants, geographic variations and socio-economic related factors. Our secondary objectives are: 1) to investigate if the prescription of a second-line oral glucose lowering agent was an addition or switch of therapy; 2) time to treatment change. Mean time to change in treatment will be estimated per drug class by using Kaplan-Meier survival analysis, with change in treatment as the outcome event. Determinants of treatment change will be estimated by Cox proportional hazards regression. Results will be presented separately for patients with a treatment modification before and after the introduction of the new NICE guideline (December 2015).
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A quasi-experimental study to assess the effectiveness of an educational intervention for improving identification and management of familial hypercholesterolemia in general practice — Ralph Kwame Akyea ...
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A quasi-experimental study to assess the effectiveness of an educational intervention for improving identification and management of familial hypercholesterolemia in general practice
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-14
Organisations:
Ralph Kwame Akyea - Chief Investigator - University of Nottingham
Ralph Kwame Akyea - Corresponding Applicant - University of Nottingham
Emily Wallbanks - Collaborator - University of Nottingham
Jo Leonardi-Bee - Collaborator - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of NottinghamOutcomes:
Primary outcome:
 Number of patients diagnosed with familial hypercholesterolaemia (FH)Secondary Outcomes:
 Indicators related to change in identification and management of familial hypercholesterolaemia
- Number of patients diagnosed with possible FH, arcus senilis/xanthalasma, secondary cause of FH;
- Proportion of patients with the following assessed: any family history of heart disease, complete family history of coronary heart disease, thyroid stimulating hormone, glycated haemoglobin, serum creatinine, bilirubin, ALP, gamma GT, repeat cholesterol test.Description: Technical Summary
Background: Familial hypercholesterolaemia (FH) is a common inherited cause of raised cholesterol which puts an individual at risk of premature coronary heart disease and myocardial infarction. Under-diagnosis and mis-identification of patients with familial hypercholesterolemia is, therefore, an important issue. The Simon Broome criteria, however, informs general practitioners of risk factors which should prompt further investigation and possible referral to familial hypercholesterolemia specialists.
Objective: The aim of the study is to assess the effectiveness of an educational intervention for general practitioners in the identification and management of familial hypercholesterolemia in primary care.
Study Design: Quasi-experimental
Setting: UK General Practices in England: 6 general practices using EMIS system in East Midlands where FH identification and management intervention was carried out and 24 comparison general practices using VISION system from across England
Participants: Patients aged 18 years and over, with a record of cholesterol at a level > 7.5mmol/L and without a confirmed diagnosis of FH
Exposure/Intervention: Educational intervention informing general practitioners of the Simon Broome criteria and NICE guidelines on diagnosis and management of familial hypercholesterolemia; alert-system on the computer system informing GPs of eligible patients; and provision of laminated sheets outlining the Simon Broome criteria.
Comparator: No education intervention for the diagnosis and management of familial hypercholesterolemia.
Outcomes: Primary outcome  number of patients diagnosed with FH; Secondary outcomes  indicators related to a change in identification and management of patients with FH at the general practice level.
Methods: Retrospective records for eligible patients from the 24 randomly selected general practices will be obtained from the Clinical Practice Research Datalink from 2013 and 2015. A differences-in-differences analysis will be conducted, to compare changes in outcomes between the 6 intervention general practices which were given an education intervention with 24 comparison general practices which were not given the intervention.
Outputs: Quantify the effect of the educational intervention on patient identification and management; determine the significance of any differences. Findings to inform the possibility of rolling-out the educational intervention to more general practices.
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The association between bariatric surgery and incident hip or knee arthroplasty: A matched cohort study in obese patients — Susan Jick ...
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The association between bariatric surgery and incident hip or knee arthroplasty: A matched cohort study in obese patients
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-14
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Marlene Rauch - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Raoul Furlano - Collaborator - University Children's Hospital Basel
Theresa Burkard - Collaborator - University of Basel
Thomas Huegle - Collaborator - University of Basel
Tracy Glass - Collaborator - University of BaselOutcomes:
Knee arthroplasty
 Cataract surgery
 Spinal surgery (decompression and fusion)
 Hip arthroplasty
 Inguinal hernia surgery
 Colonoscopy
 CholecystectomyDescription: Technical Summary
Among a population of patients who are linked to HES data, we will first validate the records of bariatric surgery (BS) in the CPRD through a comparison with HES APC data by estimating sensitivity and specificity and also describe BS patients.
Secondly, we will conduct a 1:4 matched cohort study to assess the association between incident BS and incident total hip or knee replacement (THR/TKR) in obese patients. Each BS patient will be matched to four patients who did not undergo BS on age, sex, body mass index (BMI), presence or absence of obesity-related metabolic disease, calendar time, and years of recorded history on the CPRD. We will follow all patients from the day of BS or the matched date (comparison group) to the first of the following: elapse of 15 years of follow-up, a Read code for THR/TKR (the outcome), end of the patient record, development of an exclusion criterion (see below), or end of the study period. We will perform subgroup analyses by sex, age, BMI groups, arthroplasty location, and duration of follow up (if necessary, see below). An extended Cox model will be applied to calculate hazard ratios (HR) with 95% confidence intervals (CI) of incident THR/TKR in association with incident BS adjusted for socioeconomic status (SES), sleep apnoea (time-varying), cardiovascular disease status (time-varying), Charlson comorbidity score (time-varying), and GP practice (random effect).
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Rate and risk of cardiovascular events and all-cause mortality in individuals with type 2 diabetes, with and without microalbuminuria - a cohort study in the CPRD database — Kamlesh Khunti ...
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Rate and risk of cardiovascular events and all-cause mortality in individuals with type 2 diabetes, with and without microalbuminuria - a cohort study in the CPRD database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-31
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Usman Muhammad - Corresponding Applicant - University of Leicester
Clare Gillies - Collaborator - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of LeicesterOutcomes:
Cardiovascular events (composite endpoint of myocardial infarction, stroke and cardiovascular death)
- Renal events (composite endpoint of new-onset of macroalbuminuria, doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease)
- Mortality and causes of deathDescription: Technical Summary
The potential high risk of cardiovascular events and mortality in T2DM patients with/without microalbuminuria, has not been fully evaluated. This study aims to estimate the overall cardiovascular, renal disease and mortality rates in people with T2DM with/without microalbuminuria. The study will also explore whether there is an association between microalbuminuria and cardiovascular risk and mortality in a real-world setting of people with T2DM. All T2DM patients will be included in this study diagnosed between 01-Jan-2008 and 31-Dec-2012. Time-to-event analysis will be conducted with adjustment for a wide range of confounders including demographics, lifestyle variables, prescriptions and deprivation category. Linked external datasets will contribute to evaluation of cardiovascular outcomes and causes of deaths. This study will provide useful information about the rate and risk of cardiovascular and renal events and all-cause mortality in T2DM individuals with and without microalbuminuria.
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Up-titration and distribution of dose of metformin monotherapy in the real-world — Kristy Iglay ...
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Up-titration and distribution of dose of metformin monotherapy in the real-world
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-24
Organisations:
Kristy Iglay - Chief Investigator - Merck & Co., Inc.
Kristy Iglay - Corresponding Applicant - Merck & Co., Inc.
Alex Z. Fu - Collaborator - CHEORS
Baanie Sawhney - Collaborator - CHEORS
Gail Fernandes - Collaborator - Merck & Co., Inc.
Kamlesh Khunti - Collaborator - University of Leicester
Michael Crutchlow - Collaborator - Merck & Co., Inc.
Swapnil Rajpathak - Collaborator - Merck & Co., Inc.Outcomes:
Metformin dose distribution
- Goal attainment
- Time to add-on therapy
- Up-titration of metformin dose
- Sociodemographic and clinical factors associated with up-titration
- Time to highest dose of metformin
- Treatment intensification (i.e., add-on therapy)Description: Technical Summary
In order to assess metformin dose and up-titration patterns, the current study will identify T2DM patients >/=21 years from the CPRD database with a prescription for metformin monotherapy between Jan-2017 and Dec-2017 for prevalent users and Jan-2013 to Dec-2016 for new users. The index date for prevalent users is the last metformin prescription during the period and for new users it is the first prescription. All users need to have continuous enrolment in the database one year prior to the index date. New users need continuous enrolment in the database for 15 months following the index date. This study will investigate the distribution of metformin dose in the real world among prevalent users. Among new users, it will describe the distribution of dose at initiation, 3, 6 and 12 months, the proportion of patients who up-titrate therapy at each time point, and the time to highest dose of metformin among those who up-titrate. Data will be censored if patients discontinue metformin or add another diabetes medication during follow-up. Measures of central tendency and dispersion for continuous variables and frequency/percentages for categorical variables will be reported. Cumulative incidence function will be used to estimate time to up-titration for new users
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Acute exacerbation of idiopathic pulmonary fibrosis in the UK: incidence, mortality and disease severity — Michael Marcus ...
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Acute exacerbation of idiopathic pulmonary fibrosis in the UK: incidence, mortality and disease severity
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-22
Organisations:
Michael Marcus - Chief Investigator - University of Liverpool
Michael Marcus - Corresponding Applicant - University of Liverpool
Chris D Poole - Collaborator - Digital Health Labs Limited
Deborah Clarke - Collaborator - Boehringer-Ingelheim - UK
Prithwiraj Das - Collaborator - Boehringer-Ingelheim - UK
Sophie Fletcher - Collaborator - University Hospital SouthamptonOutcomes:
Incidence rate of acute exacerbation in IPF patients
Incidence rate of acute exacerbation in IPF patientsDescription: Technical Summary
IPF population from CPRD will be linked with HES in order to determine eligible patients for our proposed study population.
Descriptive statistics (counts and percentages for categorical variables; and mean, range and SD for continuous variables (additionally median, IQR for non-normally distributed variables)) will be generated to describe the cohort of IPF patients at diagnosis in relation to age (continuous and categorical data), sex, BMI (continuous and categorical data) and year of diagnosis.
Patients' pre-diagnosis history will be assessed for the period preceding IPF diagnosis to the date of registration with the clinical practice. Descriptive statistics will be generated to describe the most common medical conditions experienced by patients prior to IPF diagnosis.
Finally, FVC will be categorized in three groups at diagnosis (<50% predicted, 50%-80% predicted, >80% predicted). FVC at diagnosis will be defined as the first FVC measurement between diagnosis and 90 day period post diagnosis. If not available, FVC at diagnosis will be defined as the latest FVC closest to the diagnosis date.
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High-need patients with chronic conditions: primary and secondary care utilisation and costs, by social and demographic characteristics in high income countries. — Hannah Knight ...
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High-need patients with chronic conditions: primary and secondary care utilisation and costs, by social and demographic characteristics in high income countries.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-16
Organisations:
Hannah Knight - Chief Investigator - The Health Foundation
Yannis Kotrotsios - Corresponding Applicant - The Health Foundation
Adam Steventon - Collaborator - The Health Foundation
Arne Wolters - Collaborator - The Health Foundation
Carlotta Greci - Collaborator - The Health Foundation
Fiona Grimm - Collaborator - The Health Foundation
Julia Shen - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Karen Hodgson - Collaborator - The Health Foundation
Kathryn Dreyer - Collaborator - The Health Foundation
Mai Stafford - Collaborator - The Health Foundation
Sarah Deeny - Collaborator - The Health Foundation
Will Parry - Collaborator - The Health FoundationOutcomes:
Types of health care utilisation
- Quality of care indicators
- Cost of health care utilisationDescription: Technical Summary
Objectives: Greater understanding of the health care provided for high-need patients offers an opportunity to improve outcomes, value and health. We focus on three high-need patient personas (an older person with dementia, an older person hospitalised for hip fracture, and someone hospitalised with heart failure who has co-morbidity). This international comparative study will: harmonise the operationalisation of these patient personas using data from 11 countries; compare total health care spending (using available data on direct costs to the NHS) and care quality; and compare differences in the specific patterns of health care utilisation (e.g. emergency admission versus in-patient care versus community prescribing). It builds on project reference ISAC 17_150R which compared high-cost patients across countries.
Methods: A cross-sectional study of anonymised CPRD patients registered in 2012-2016 with i) prevalent dementia and aged 65-90, ii) hospital admission for hip fracture and aged 65-90, iii) hospital admission for heart failure plus prevalent diabetes or COPD. Data on costs (including inpatient and outpatient care, emergency admissions, and prescribed medications), utilisation and care quality indicators (including continuity of care, appointment length) over a 12-month period will be derived from CPRD and linked Hospital Episode Statistics and ONS mortality records.
Data Analysis: This is a descriptive study. Comparators are the same patient personas in the other 10 collaborating countries. We will additionally describe costs, utilisation and care quality by gender, age group (65-75, 75-90 years), and IMD quintile. Adjustment will be made for possible confounding by ethnicity, rurality, living alone, number of chronic conditions and practice level practitioner supply.
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Persistence and adherence to controlled release formulations of sodium valproate for the treatment of epilepsy and their clinical and resource use implications. — Hassan Chaudhury ...
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Persistence and adherence to controlled release formulations of sodium valproate for the treatment of epilepsy and their clinical and resource use implications.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-29
Organisations:
Hassan Chaudhury - Chief Investigator - Health iQ
Austen El-Osta - Collaborator - Imperial College London
Chris D Poole - Collaborator - Digital Health Labs LimitedOutcomes:
A. Proportion of Days Covered (PDC) - (total days all drug(s) available/days in follow-up period)
B. Medication Possession Ratio (MPR) - (total Rx days of supply/last Rx date - first Rx date + last Rx days of supply)
C. Time to switch/discontinuation (days) - discontinuation will be said to have occurred when any gap between CR valproate prescriptions exceeds a maximum allowable gap duration (MAGD) of (1.5 x the number of days supply of the last prescription).
D. Incidence rate of overall emergency admission or A&E visit - assessed only in HES eligible patients
E. Incidence rate of epilepsy-related emergency admission or A&E visit - assessed only in HES eligible patients
F. Incidence rate of overall Outpatient contacts - assessed only in HES eligible patients
G. Incidence rate of overall primary healthcare care professional contacts
H. Incidence rate of epilepsy related primary healthcare care professional contacts - where the consultation includes a Read code related to epilepsy (see Appendix)
I. Annualised tariff cost of D) ppy observed - assessed only in HES eligible patients applying current payment-by-results tariff (18) to the Health Resource Group allocation for the admission
J. Annualised estimated cost of G) ppy observed - derived by applying published costs for units of Healthcare (19)
K. Annualised total primary care medication costs ppy observed - derived by applying electronic Drug Tariff costs to prescriptions issued during observation period (20)Description: Technical Summary
The primary objective of this study is to describe the persistence and adherence to modified release formulations of sodium valproate for the treatment of epilepsy and their clinical and resource use implications, for two alternative forms of oral CR valproate (Episenta and Epilim Chrono). Treatment adherence will be measured by Proportion of Days Covered (PDC) and Medication Possession Ratio (MPR).
CR valproate-naive adult and paediatric (under 18 years) sub-groups of patients with diagnosed epilepsy will be assigned cohort membership based on their first-ever exposure to either Episenta formulations (minitablets in either capsules or sachets) or Epilim Chrono monolithic tablets. The cohorts will be randomly matched according to age group; and propensity score using parsimonious matching (no recycling) and a caliper of 0.1 in a ratio of 1 to 4 respectively. The primary endpoint will be proportion of patients achieving high adherence as determined by PDC>0.8. The margin of non-inferiority is empirically set as -0.1 (a 10% difference in proportion). If non-inferiority is met, a superiority hypothesis will be alternatively tested.
The combined cohorts will also be used to explore the association between measures of anti-epileptic drug (AED) treatment adherence and the outcomes of seizure frequency and healthcare resource use using UK linked primary care and Hospital Episode Statistics records to maximise case ascertainment.
The choice of valproate as a reference for the study is primarily because it is the first line treatment for most seizure types and syndromes according to NICE guidelines, particularly for children and young adults. These guidelines have made sodium valproate one of the most commonly used agents in the country for epilepsy in that population, serving as a good reference for AED treatment modifications.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 11 - Replication of "Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 11 - Replication of "Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-29
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Frequency of co-prescription of CYP3A4-metabolised statins and CYP3A4 inhibitors
Description: Technical Summary
This objective of this protocol is to replicate the study: "Co-administration of statins with cytochrome P450 3A4 inhibitors in a UK primary care population" by Bakhai et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Bakhai paper measures the frequency of concomitant exposure of patients to CYP3A4-metabolised statins and CYP3A4 inhibitors in the general population of the United Kingdom (UK) between 2007 and 2008. We will focus on replicating the outcome of frequency of co-prescription of CYP3A4-metabolised statins and CYP3A4 inhibitors over this time period. Concomitant exposure was defined as exposure to a statin and a CYP3A4 inhibitor on the same day. For each statin, patient demographics, duration of statin use, duration of CYP3A4 inhibitor use, duration of concomitant statin and CYP3A4 inhibitor use and proportion of patients with concomitant use of statin and CYP3A4 inhibitor will be reported.
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Is seasonal influenza vaccine effectiveness reduced in people receiving repeat vaccinations? A retrospective cohort study using the Clinical Practice Research Database — Jonathan Van...
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Is seasonal influenza vaccine effectiveness reduced in people receiving repeat vaccinations? A retrospective cohort study using the Clinical Practice Research Database
Datasets:GP data, Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-14
Organisations:
Jonathan Van-Tam - Chief Investigator - University of Nottingham
Hikaru Bolt - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Abhishek Abhishek - Collaborator - University of Nottingham
Benjamin Cowling - Collaborator - University of Hong Kong
Georgina Nakafero - Collaborator - University of Nottingham
Puja Myles - Collaborator - CPRD
Shuo Feng - Collaborator - University of Hong Kong
Sudhir Venkatesan - Collaborator - University of Nottingham
Wey Wen Lim - Collaborator - University of NottinghamOutcomes:
Acute respiratory illness
- Influenza-like-illness
- GP diagnosed influenzaDescription: Technical Summary
A debate has re-emerged on the possible effect of previous influenza vaccinations on the vaccine effectiveness (VE) of seasonal influenza vaccine (SIV). The aim of this study is to examine whether VE was lower in people with repeat vaccination histories relative to first time vaccines in the 2015/2016 winter season. We will conduct a retrospective cohort study of people vaccinated in the 2015/2016 winter season aged >65 years old and those aged 12 to 65 in clinical risk groups. The analysis will examine the occurrence of influenza infection, influenza-like-illness and acute respiratory infection among those who have a five-year history of SIV and those who are first time SIV recipients. Hazard ratios will be estimated using Cox regression, relative VE of the 2015/2016 influenza vaccine will be calculated as 1 - Hazard ratio and by previous vaccination history type (in one to five previous seasons). Relative VE will be adjusted for sex, age, comorbidities, previous influenza infection in the past five years, smoking status, index of multiple deprivation (IMD), body mass index (BMI), use of statins and immunosuppressive drugs. We will repeat the analyses for previous winter seasons back to 2011-12, but looking at two-year history of SIV.
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Effect of stepping down (reducing) a stable asthma patientÂs maintenance medication on the risk of an acute asthma attack — Jennifer Quint ...
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Effect of stepping down (reducing) a stable asthma patientÂs maintenance medication on the risk of an acute asthma attack
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-29
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
Asthma attacks
 Reducing asthma medication
 Increasing asthma medicationDescription: Technical Summary
We will used CPRD to identify asthma patients and their medication, and describe how often patients step down, or step up, their maintenance asthma medication, according to British asthma clinical guidelines, between 2000 and 2016. We will use a Poisson regression model to identify factors associated with stepping down, and stepping up, asthma maintenance medication.
Next we will use CPRD, linked with HES and ONS, to conduct a matched cohort study, the exposures will be stepping down asthma treatment, according to clinical guidelines, and the main outcome will be asthma attacks (treated in primary and secondary care). A secondary outcome will be stepping asthma treatment back up. Patients will be matched by GP practice, asthma severity, age and gender. A Cox proportional hazards model will be used to estimate the hazard ratios and their corresponding 95% confidence intervals. Multiple potential confounders or effect modifiers will be included in the model to obtain adjusted estimates, and to identify factors affecting the association between the exposure and the outcomes.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 10 - Replication of "Prevalence and Burden of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease Managed in Primary Care" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 10 - Replication of "Prevalence and Burden of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease Managed in Primary Care"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-03
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Prevalence and burden of breathlessness
Description: Technical Summary
This objective of this protocol is to replicate the study: "Prevalence and Burden of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease Managed in Primary Care" by Mullerova et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Mullerova paper describes the frequency of breathlessness and factors associated with it in a cohort of COPD patients managed in primary care from the CPRD database between 2008 and 2011. We will focus on replicating the outcome of the frequency of moderate-to-severe breathlessness for COPD patients managed in primary care over this time period. Moderate-to-severe dyspnoea will be assessed as Medical Research Council (MRC) dyspnoea grade greater than 3.
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Evaluation of the Burden and Management of Musculoskeletal Diseases — Philip Conaghan ...
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Evaluation of the Burden and Management of Musculoskeletal Diseases
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-21
Organisations:
Philip Conaghan - Chief Investigator - University of Leeds
Samantha Crossfield - Corresponding Applicant - University of Leeds
Gillian Libby - Collaborator - University of Leeds
Mar Pujades Rodriguez - Collaborator - University of Leeds
Oras Alabas - Collaborator - University of Leeds
Owen Johnson - Collaborator - University of Leeds
Paul David Baxter - Collaborator - University of Leeds
Samantha Sykes - Collaborator - University of Leeds
Sarah Kingsbury - Collaborator - University of LeedsOutcomes:
Routes to diagnosis: screening, referral, symptoms (fatigue, hyperuriceamia, stiffness, back pain, hip pain, joint pain, itchy rash, scalp rash) related auto-inflammatory diseases (achilles tendinitis / tendinopathy, plantar fasciitis, apical lung fibrosis, anterior uveitis, psoriasis)
- Prevalence and incidence of disease from 1998: rheumatoid arthritis, ankylosing spondylitis, gout, psoriatic arthritis, psoriasis
- Health resource utilisation rates: GP consultation (face-to-face, telephone, video), sick leave, referral to orthopaedic, rheumatology or dermatology, joint aspiration, prescription exemption, total hip or knee replacement, over the counter aspirin therapy
- Prescribing rates/timing/duration of drugs from BNF list including: non-steroidal anti-inflammatories (NSAIDs), colchicine, urate lowering therapy (ULT), disease-modifying anti-rheumatics (DMARDs), analgesics, steroids, calcium and vitamin D supplements, bisphosphonates, statins, diuretics, low-dose aspirin, proton pump inhibitors, H2-receptor antagonists, capecitabine, azapropazone, ciclosporin, anti-hypertensives, lipid-lowering, opioids, canakinumab
- Adverse drug reactions: drug sensitivity to NSAIDs, steroids, ULT or DMARDs, peptic ulcer (including perforation or bleed)
- Other management / quality indicators: duration from joint symptom to diagnosis, drug monitoring, disease review, DAS28, comorbidity screening (CVD, depression, tuberculosis), lifestyle advice (smoking, alcohol, diet, weight/BMI), lifestyle factors (smoking, alcohol, weight/BMI), tests (full blood, white cell, neutrophil, platelet, glucose, lipid, urate, liver function, urea and electrolytes, C-reactive protein, rheumatoid factor, creatinine kinase, ESR, anti-CCP, ECG), blood pressure, joint evaluation, live vaccinations (BCG, influenza - nasal, MMR, polio, rotavirus, typhoid, varicella-zoster, yellow fever), influenza and pneumococcal vaccines
- Prevalence and incidence of complications / comorbidities: hypertension, hyperlipidaemia, hypercholesterolemia, hypertriglyceridemia, CHD, heart failure, stroke, depression, diabetes, anterior uveitis, inflammatory bowel disease (undifferentiated, Crohn's, ulcerative colitis), osteoporosis, sleep apnoea, valvular heart disease, reactive arthritis, renal disease, psoriasis
- All-cause mortality and the following specific causes of death (coronary heart disease, heart failure, sudden cardiac death, stroke) from 1998.Description: Technical Summary
There is incomplete understanding of the burden of inflammatory musculoskeletal diseases and variation in management in terms of spatio-temporal and demographic factors. For example, English studies of ankylosing spondylitis have evaluated risk factors, comorbidities and the validity of diagnostic codes, but the incidence and prevalence of disease, sick-leave rate and pattern of resource-use and management in routine primary care is unknown and we will examine this. Where the distribution and burden of diseases such as psoriatic arthritis are better known, the quality of routine care remains largely unstudied. We will apply quality indicators for timely diagnosis and management to describe current practice and care quality. We will also examine spatio-temporal variation in relation to patient characteristics and local guidelines. Where quality has been measured there is great variance, for example the steadily increasing use of effective treatment with DMARDs for rheumatoid arthritis, compared to the consistently suboptimal use of ULTs for gout. We will assess spatio-temporal and patient-related prescribing patterns and adverse events among incident and prevalent cohorts and the impact of more effective therapy on prescribing rates for traditional therapy including NSAIDs. This will inform understanding of the burden and variation in management of musculoskeletal diseases.
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How does use of secondary prevention medication after stroke vary between different patient groups? — Duncan Edwards ...
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How does use of secondary prevention medication after stroke vary between different patient groups?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-24
Organisations:
Duncan Edwards - Chief Investigator - University of Cambridge
Duncan Edwards - Corresponding Applicant - University of Cambridge
Efthalia (Lina) Massou - Collaborator - University of Cambridge
James Brimicombe - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of Cambridge
Zhirong Yang - Collaborator - University of CambridgeOutcomes:
Stroke incidence
- Antihypertensive prescription
- Statin prescription
- Antiplatelet prescription
- Anticoagulant prescription
- Blood pressure <130/80mmHgDescription: Technical Summary
Recurrent strokes account for over 20% of all strokes, yet there is evidence that uptake of stroke prevention medications has stalled in the last ten years, and that certain groups within the stroke survivor population may be missing out on effective prevention treatment, including patients with mental health problems, patients with non-cardiovascular co-morbidities, and patients with increased disability.
The object of this study is to investigate variability in the usage of statins, antihypertensive medications, and anti-platelets or anticoagulants in a stroke survivor population.
First, we will describe key characteristics of the stroke and transient ischaemic attack (TIA) population in July 2017 (prelude to cross-sectional study) and key characteristics of patients experiencing their first stroke or TIA between 2006-2017 (prelude to retrospective cohort study).
Second, we will conduct a cross sectional study which will describe medication usage within the stroke or TIA survivor population in July 2017 and identify factors associated with stroke prevention medication-taking.
Third, a retrospective cohort study will investigate uptake and persistence with medications within patients experiencing their first stroke or TIA between January 2006 and December 2017.
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Impact of removing Quality and Outcomes Framework financial incentives from English Primary Care — Matt Sutton ...
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Impact of removing Quality and Outcomes Framework financial incentives from English Primary Care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-01
Organisations:
Matt Sutton - Chief Investigator - University of Manchester
Anna Wilding - Corresponding Applicant - University of Manchester
Bruce Guthrie - Collaborator - University of Edinburgh
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Luke Munford - Collaborator - University of Manchester
Rachel Meacock - Collaborator - University of ManchesterOutcomes:
Health Outcomes: clinical indicator met or not met
Description: Technical Summary
NHS England are currently conducting a review of the Quality and Outcomes Framework (QOF), a primary care financial incentivisation scheme that started in 2004. It is possible that some elements of the scheme may be removed and it is important to understand what happens to quality standards when such incentives are removed. One of the key areas for investigation is the potential impact of removing the incentives on the quality of care delivered in general practice. There is limited evidence on the effect of removing indicators from pay-for-performance schemes and what evidence is available is contradictory.
By applying interrupted time series analysis to CPRD data (2006-2020), we will determine the effect of the retirement of QOF indicators on quality of care. To add to the literature that predominantly focuses on practice-level data, we will conduct patient-level analysis to consider heterogeneous effects by considering specific subpopulations and identify the distributional consequences of removing incentives. This is key to understanding the potential risks associated with removing incentives. We are expecting the findings from this research to aid NHS England with the review and the wider effects of the review.
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Blood eosinophilia, withdrawal of inhaled corticosteroids and risk of COPD exacerbations and mortality — Frank de Vries ...
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Blood eosinophilia, withdrawal of inhaled corticosteroids and risk of COPD exacerbations and mortality
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-20
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Anthonius de Boer - Collaborator - Utrecht University
Frits Franssen - Collaborator - CIRO
Johanna Driessen - Collaborator - Utrecht University
Miel (Emiel) Wouters - Collaborator - CIRO
Olorunfemi Oshagbemi - Collaborator - Utrecht University
Suzanne van Kraaji - Collaborator - Maastricht University Medical CentreOutcomes:
Acute exacerbations of COPD
- COPD Hospitalisation
- All-cause mortalityDescription: Technical Summary
Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and airflow obstruction is a major cause of morbidity and mortality worldwide. Smoking and noxious particles results in irreversible damage to the lungs. Although eosinophilic airway inflammation is usually considered a feature of asthma, it has also been recently found to play an important role in COPD patients. Exacerbations play an important role in the progression of airflow limitation, deterioration of health status and increased mortality of COPD patients. Therefore, preventing exacerbations is one of the major goals in the treatment of the disease. Traditionally, inhaled corticosteroids (ICS) are prescribed to reduce exacerbations. However, ICS are associated with side effects and are ineffective in some patients. Patients with elevated eosinophil's are believe to benefit from ICS. The aim of this study is to evaluate the effects of withdrawal of ICS among COPD patients with varying blood eosinophilic inflammation on the risk of exacerbations, hospitalisation/accident & emergency visits and all-mortality. We will use Cox regression analysis to identify the risk of the acute exacerbation, hospitalisation and all-cause mortality adjusting for relevant confounders, among patients with different blood eosinophil levels. Withdrawal of ICS will be determined time-dependently.
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Describing the Cumulative Anticholinergic Burden in Patients Over the Age of 65, With Overactive Bladder, and the Association to Healthcare Resource Utilization. A Retrospective Observational Study Using UK Electronic Medical Records (EMR) data. — Margarita Landeira ...
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Describing the Cumulative Anticholinergic Burden in Patients Over the Age of 65, With Overactive Bladder, and the Association to Healthcare Resource Utilization. A Retrospective Observational Study Using UK Electronic Medical Records (EMR) data.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-01
Organisations:
Margarita Landeira - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Ashley Jaggi - Corresponding Applicant - Astellas Pharmaceuticals
Celine Quelen - Collaborator - Creativ-Ceutical
Francis Fatoye - Collaborator - Manchester Metropolitan University
Laurie Cooper - Collaborator - Manchester Metropolitan University
Ramzi Argoubi - Collaborator - Creativ-Ceutical
Sameh Ferchichi - Collaborator - Creativ-Ceutical
Vasileios Giagos - Collaborator - Manchester Metropolitan University
Xinyi Tu - Collaborator - Creativ-CeuticalOutcomes:
Number of GP consultations (surgery appointment, clinic, home visit, telephone consultation)
- Number of specialist consultations (psychiatrists/memory clinic, neurologists and geriatrics)
- Number of hospital admissions (planned visits and emergency department)Description: Technical Summary
Objective: To determine the association between cumulative anticholinergic burden, calculated using the anticholinergic cognitive burden (ACB) scale, and healthcare resource utilization (HRU) in older individuals with OAB (> 65 years).
Methods: We will identify overactive bladder (OAB) patients from the Clinical Practice Research Datalink (CPRD) GOLD database between 1st January 2006 - 31st January 2016. The mean total daily ACB score over the three-year pre-index period will be calculated and its association to HRU (GP visits, visits to specialists (psychiatrists/memory clinics, neurologists, and geriatrics), and hospitalisations) over the two-year post-index period determined through use of generalised linear models (GLM).
Analysis: Aggregated summary statistics will be provided on patient baseline characteristics. We will compare characteristics amongst ACB groups using the chi-square test, two-sample t-test or ANOVA, and mann-whitney or kruskal-wallis test respectively. The statistical model will assess the impact of cumulative mean total daily ACB on the frequency of HRU. Continuous ACB will be categorized and inputted as the predictor variable into the GLM (e.g. with Poisson, lognormal or gamma distribution since the distribution of HRU variables may be skewed).
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT) Study 12 : ÂQuantification of the risk of liver injury associated with flucloxacillin: a UK population-based cohort study — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT) Study 12 : ÂQuantification of the risk of liver injury associated with flucloxacillin: a UK population-based cohort studyÂ
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-29
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Liver injury
Description: Technical Summary
This objective of this protocol is to replicate the study: ÂQuantification of the risk of liver injury associated with flucloxacillin: a UK population-based cohort study by Wing et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Wing paper evaluates the relative and absolute risks of liver injury following exposure to flucloxacillin compared to oxytetracycline in the general population of the United Kingdom (UK) between 2000 and 2012. We will focus on replicating measures of relative and absolute risk for liver injury over this time period. We will focus on replicating the baseline cohort characteristics and the adjusted risk ratio for laboratory confirmed injury within 1-45 days of antibiotic initiation. The risk ratio will be adjusted using multivariable logistic regression.
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Treatment patterns and burden of agitation in patients with Alzheimer's disease in the UK — Kristian Tore Jørgensen ...
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Treatment patterns and burden of agitation in patients with Alzheimer's disease in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-20
Organisations:
Kristian Tore Jørgensen - Chief Investigator - Lundbeck Limited
Michelle Johnson - Corresponding Applicant - Roche
Lucy Tran - Collaborator - OXON Epidemiology - UK
Martin Bog - Collaborator - Lundbeck Limited
Nawab Qizilbash - Collaborator - OXON Epidemiology - SpainOutcomes:
Number of patients prescribed antipsychotic (AP) therapy during each calendar year
Prescribing rates of APs and other psychotropic drugs
Total days of AP supply per person-year
Number of AP prescriptions
Dose of initial risperidone prescription and highest dose of all risperidone prescriptions
Number of patients with a referral for non-pharmacological treatment
Adherence to APs
Persistence to APsDescription: Technical Summary
Background: Antipsychotics (APs) are used in the treatment of neuropsychiatric symptoms (NPS) of Alzheimer's disease (AD). Despite newer atypical APs having improved safety profiles compared to older typical APs, severe adverse effects remain and there is a drive to reduce AP use in dementia. Evidence on AP use for NPS in patients with AD is lacking.
Objectives: This study will describe the use and treatment patterns of APs for NPS, specifically agitation, a common symptom in patients with AD.
Methods: People with AD will be identified between 1 April 2004 and 31 December 2017. 1) Prescribing rates and treatment patterns for different AP types will be described in two recent time windows (2017 and 2015-2017) for patients classified into NPS descriptive cohorts. 2) Changes over time will be assessed by describing rates and patterns in each calendar year of the study period. 3) Patient characteristics will be described and compared across NPS descriptive cohorts 4) Treatment patterns will be compared across NPS groups for the recent time window (2015-2017).
Importance: This valuable up-to-date information, in a large number of people with AD, identified from a representative UK population, will help understand the current clinical management of dementia and NPS.
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The association between inflammatory markers measured in blood and incident seizures — Susan Jick ...
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The association between inflammatory markers measured in blood and incident seizures
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-14
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Cornelia Schneider - Corresponding Applicant - University of Basel
Bojana Vulin - Collaborator - University of Basel
Charlotte Holze - Collaborator - University of Basel
Christoph Meier - Collaborator - University of Basel
Marlene Rauch - Collaborator - University of BaselOutcomes:
Seizures
Description: Technical Summary
Using a case-control design, we intend to characterise patients with a first-time recorded seizure between 2007 and 2016 and a matched comparison group of patients without seizures, focusing particularly on inflammatory processes present prior to the seizure. We will assess infections and inflammatory markers focusing on severity and timing of the inflammatory processes. We will classify C-reactive protein (CRP) levels, neutrophil-to-lymphocyte ratios and platelet-to-lymphocyte ratios into quintiles, or into a priori defined categories of low, normal or high levels. Performing conditional logistic regression analysis, we will evaluate whether various categories of inflammation are differentially associated with the risk of seizures. If possible, we will also assess the effect of the patients' age, underlying type, site, and treatment of infection and do subgroup analyses restricted to patients with no major risk factors for seizures.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 5 - Replication of "Pioglitazone use and risk of bladder cancer: population based cohort study" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 5 - Replication of "Pioglitazone use and risk of bladder cancer: population based cohort study"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-05-03
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Whether pioglitazone compared with other antidiabetic drugs is associated with an increased risk of bladder cancer in people with type 2 diabetes
Description: Technical Summary
This objective of this protocol is to replicate the study: "Pioglitazone use and risk of bladder cancer: population based cohort study" by Tuccori et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Tuccori paper compares pioglitazone with other antidiabetic drugs in association with an increased risk of bladder cancer in people with type 2 diabetes between 1 January 2000 and 31 July 2013 in the UK. We will focus on replicating the outcome of incident bladder cancer associated with pioglitazone. Cox proportional hazards models will be used to estimate adjusted hazard ratios with 95% confidence intervals of incident bladder cancer associated with pioglitazone overall and by both cumulative duration of use and cumulative dose.
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Mapping the care pathways for ulcerative colitis patients in North West London — London North West University Healthcare Trust...
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Mapping the care pathways for ulcerative colitis patients in North West London
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: May-18
Opt Outs: no information provided./p>
Organisations: London North West University Healthcare Trust
Description: Ulcerative Colitis. Commercial
Source
2018 - 04
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Healthcare resource utilisation associated with hepatocellular carcinoma in the UK — Christopher Morgan ...
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Healthcare resource utilisation associated with hepatocellular carcinoma in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-02
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Ronda Copher - Collaborator - Eisai Pharmaceuticals
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Frequency of Visit to the GP
- Prescriptions issued in the community
- Progression of Disease
- Medical Diagnosis of comorbidities
- Mortality
- Secondary care contactsDescription: Technical Summary
The aim of this study is to use a retrospective cohort design to estimate the healthcare resource utilisation and costs associated with Hepatocellular carcinoma (HCC). The CPRD GOLD and linked datasets (HES admitted patient care, outpatient and accident and emergency and the Cancer Registry) will be used. The study will be limited to CPRD acceptable patients, registered at an up-to-standard practice who are eligible for the CPRD linkage scheme. Patients with HCC will be identified during the study period (2007-16) based on a Read (CPRD GOLD) or ICD-10 (HES admitted patient care and Cancer Registry) code. Identified cases will be matched to controls by primary care practice, age and gender. Date of first diagnosis will be the index date. The baseline characteristics of the cases and controls will be presented. All healthcare contacts and primary care issued prescriptions following index date will be identified and costed using published NHS healthcare costs. For the two year period (2014-15) where available, therapy costs will also be identified from the Cancer Registry SACT table. Costs will be compared between cases and controls using the non-parametric Wilcoxon signed-rank. In addition, the mean monthly costs of treating patients with HCC will be presented graphically to identify the most costly elements of the treatment cycle.
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The effect of smoking on post-operative complications following hip or knee joint replacement — Hemant Pandit ...
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The effect of smoking on post-operative complications following hip or knee joint replacement
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-24
Organisations:
Hemant Pandit - Chief Investigator - University of Leeds
Hemant Pandit - Corresponding Applicant - University of Leeds
Andrew Judge - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
David Murray - Collaborator - University of Oxford
Gulraj Matharu - Collaborator - University of Oxford
Nigel Arden - Collaborator - University of Oxford
Ruben Mujica Mota - Collaborator - University of Exeter
Sarah Twigg - Collaborator - University of Leeds
Victoria Matharu - Collaborator - NHS EnglandOutcomes:
Primary outcomes are post-operative complications, including the incidence of medical and surgical complications:
- Death
- Post-operative infections including septicaemia, pneumonia, urinary tract infection and cellulitis
- Length of hospital stay
- List of medications patient is on when discharged home
- Details of analgesia including duration
- Stroke
- Cardiovascular events
- DVT/Pulmonary embolism
- Wound dehiscence and/or wound infections
- Septic arthritis in replaced joint
- Readmission to hospital for any cause
- Revision of surgery
- Inpatient hospital costs (HRG) - Outpatient hospital costs (HRG)
- Costs of GP visitsDescription: Technical Summary
At this time of unprecedented financial pressures on the NHS, some clinical commissioning groups have stipulated that patients must stop smoking before routine total knee or hip replacement surgery (TKR or THR). However, there is little evidence to support these actions. Associations between smoking and poor clinical outcomes are generally accepted, but the specific impact of smoking on outcome after TKR and THR is poorly understood.
This study will use data from CPRD patients who underwent TKR or THR to compare clinical outcomes and healthcare costs in smokers and ex-smokers to those of people who have never smoked. The outcomes of surgery are: infections (wound, respiratory, urinary, and skin), wound dehiscence, myocardial infarction, stroke and transient ischaemic attack, deep vein thrombosis and pulmonary embolism, poor wound healing, readmission to hospital for any cause, analgesic use, septic arthrodesis, surgical revision and mortality. We will also evaluate 6 month change in Oxford hip or knee score and EQ-5D, and by combining these with mortality outcomes, quality-adjusted life years (QALYs). To do this we will use a retrospective cohort study design. Regression modelling will be used to describe the association of smoking on outcomes. Logistic regression will be used for binary outcomes (infections, wound dehiscence, myocardial infarction, stroke and transient ischaemic attack, deep vein thrombosis and pulmonary embolism, poor wound healing, readmission to hospital for any cause, analgesic use, septic arthrodesis), survival models (Cox and Fine & Gray) for time to event outcomes (surgical revision and mortality), and linear regression for continuous outcomes (Oxford hip and knee scores, EQ-5D, QALYs and costs). Confounding variables will be adjusted for. Missing data will be considered and sensitivity analyses performed using multiple imputation techniques.
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Abdominal pain in primary care: establishing a clinical profile and diagnostic pathway for identifying cancer — Elizabeth Shephard ...
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Abdominal pain in primary care: establishing a clinical profile and diagnostic pathway for identifying cancer
Datasets:GP data, NCRAS Cancer Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-04
Organisations:
Elizabeth Shephard - Chief Investigator - University of Exeter
William Hamilton - Corresponding Applicant - University of ExeterOutcomes:
1) To identify any new diagnosis of cancer in the two years (0-12 months and 13-24 months) following the first consultation with abdominal pain. The primary focus will be in the twelve months following the AP record, as the presence of AP is more likely to be related to the cancer than later diagnoses. A diagnosis of cancer will be ascertained by searching the clinical and referral files for medcodes (mapped to Read codes within the CPRD) relating to cancer. There are 2,134 medcodes relating to cancer within the CPRD. The diagnosis will be confirmed using cancer registry linkage. Information on cancer stage and grade will also be extracted. A sub-analysis of early versus late stage cancers will show if any investigation regime captures cancers preferentially. The date of diagnosis will be taken as the first recorded cancer code; where disparity between the CPRD and cancer registry exist, registry data will be prioritised.
2) What clinical features predict cancer in the abdominal pain group? (test: LR of cancer vs no cancer)3) In the cancer group: Which specific features predict certain cancers a) firstly single cancers and b) cancers grouped by the diagnostic test of choice?
4) Alternative diagnoses. In patients investigated for cancer, alternative explanations for AP may be found. We have assembled a short list of plausible conditions which are likely to be identified serendipitously by cancer investigation. This outcome is what other plausible causes of abdominal pain may be identified by cancer investigation in this cohort?
Description: Technical Summary
The revised 2015 National Institute for health and Care Excellence (NICE) guidelines highlight abdominal pain as a feature of several cancers reported in the 12 months before the diagnosis. This study aims to quantify the overall and individual cancer site risk of unexplained new abdominal pain episodes reported to primary care in the 24 months following the AP episode, stratified by age and gender, and by accompanying symptoms. There is a need for a more effective diagnostic pathway, which may include primary care testing or extend to investigation in the newly-established multidisciplinary diagnostic centres (MDC).
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Epidemiology of amyloidosis in the United Kingdom — Michael Broder ...
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Epidemiology of amyloidosis in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-10
Organisations:
Michael Broder - Chief Investigator - PHAR - Partnership For Health Analytic Research LLC
Michael Broder - Corresponding Applicant - PHAR - Partnership For Health Analytic Research LLC
Ashutosh Wechalekar - Collaborator - University College London ( UCL )
Eunice Chang - Collaborator - PHAR - Partnership For Health Analytic Research LLC
Jessie Tingjian Yan - Collaborator - PHAR - Partnership For Health Analytic Research LLC
Tiffany Quock - Collaborator - Prothena Biosciences IncOutcomes:
Prevalence and incidence.
Multiple rates presented by:
- year
- gender
- age group (18-34, 35-54, 55-64, 65 or older)Description: Technical Summary
The amyloidoses refer to a group of rare disorders of protein folding characterized by extracellular tissue deposition of misfolded and aggregated autologous proteins as Beta-pleated sheet fibrils. There is lack of current, nationally representative studies about the epidemiology of amyloidosis in the United Kingdom (UK). This study aims to provide an updated estimate of the prevalence and incidence of amyloidosis in the UK.
We will identify prevalent and incident patients >/=18 years old annually over the period of 1/1/2007-12/31/2017 (1/1/2008-12/31/2017 for incident patients) using diagnostic Read codes in the Clinical Practice Research Datalink (CPRD; code list below). Prevalent patients will be those with at least one diagnostic amyloidosis Read code recorded before the calendar year of interest (01 Jan) and who are still registered on 01 January of the calendar year of enumeration. Incident patients will be those with >/=1 diagnostic amyloidosis Read code in a given calendar year without for amyloidosis at any time prior to enumeration. The annual prevalence and incidence rates will be reported overall and by age and gender. Additionally, as part of the exploratory analysis, we will estimate prevalence and incidence of immunoglobulin light chain (AL) amyloidosis, the most common and severe type of amyloidosis.
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The impact of type 2 diabetes on survival in patients with cancer independent of its effect on survival in individuals without cancer: a matched cohort analysis — Darren Ashcroft ...
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The impact of type 2 diabetes on survival in patients with cancer independent of its effect on survival in individuals without cancer: a matched cohort analysis
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-29
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Nasra Alam - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Andrew G Renehan - Collaborator - The Christie NHS Foundation Trust
Martin Rutter - Collaborator - University of Manchester
Matthew Sperrin - Collaborator - University of ManchesterOutcomes:
Death from any cause
Death from cancer
Cardiovascular deathDescription: Technical Summary
Studies report that patients with cancer and type 2 diabetes (T2D) have poorer survival than patients with cancer without T2D. These studies had major weaknesses (small sample sizes, biases, confounding), and importantly, no study tested the hypothesis that T2D adversely impacts on survival, over and above the independent negative effect of T2D on survival. We propose a novel study to evaluate the effect of T2D on survival in a matched non-cancer cohort; testing the interaction between cancer and T2D on survival.
Methods: We will delineate CPRD data extracts for individuals with incident cancer (02/01/1998- 31/12/2015) linked with NCRAS - cancer cohort - and matched (1: 5) by year of birth (±2 years), sex and general practice to derive a non-cancer cohort. Derived cohorts will be linked with ONS to determine cause of death. Within each cohort, we will stratify by pre-existing T2D.
Primary outcomes: Any cause death (cancer and non-cancer cohorts); cancer deaths in cancer cohorts
Secondary outcome: Cardiovascular deaths
Models: We will develop time-to-death models from cancer diagnosis or matched index date for the non-cancer cohort. A priori, we will stratify by gender; smoking status; IMD deprivation quintiles; and Charlson comorbidity index; and model competing risks of death.
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A cohort study of infections and lymphopenia in eczema — Sinead Langan ...
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A cohort study of infections and lymphopenia in eczema
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-25
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Katrina Abuabara - Collaborator - University Of California, San Francisco
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Loes Hollestein - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Richard Silverwood - Collaborator - University College London ( UCL )Outcomes:
Rate or specific cutaneous and non-cutaneous infections in people with and without eczema
 Hospitalisations for infections in people with and without eczema
 Rate of specific cutaneous and non-cutaneous infections, and hospitalisations for infections in people with and without eczema stratified by lymphopenia statusDescription: Technical Summary
We aim to use data from the Clinical Practice Research Database (CPRD) and Hospital Episodes Statistics (HES) to examine associations between eczema and infections, and the role of lymphopenia. We will identify people with eczema in CPRD using a validated algorithm comprising Read codes and therapies and/or using ICD-10 codes in linked HES data.
Increased infection prevalence has been associated with eczema. There is a lack of longitudinal population-based data to support these associations. We will undertake a matched-cohort study to assess the strength of association between eczema and infections (Phase 1). We will then assess if this association is mediated or modified by lymphopenia (Phase 2). We will use conditional Poisson or negative binomial regression models to compute rate ratios with 95% confidence intervals to assess the associations between eczema and different infections. We will examine how robust our results are using several sensitivity analyses.
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Antibiotic Choice in UK General Practice - rates and drivers of potentially inappropriate antibiotic type in UK general practices — Tjeerd van Staa ...
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Antibiotic Choice in UK General Practice - rates and drivers of potentially inappropriate antibiotic type in UK general practices
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-17
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Tjeerd van Staa - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Magdalena Nowokowska - Collaborator - Farr Institute of Health Informatics Research
Victoria Palin - Collaborator - University of ManchesterOutcomes:
If a patient received the recommended antibiotic based on national prescribing guidelines.
Description: Technical Summary
The main objectives of this study are to determine, by conducting a population retrospective cohort study, which antibiotics are prescribed once the decision to prescribe be made for multiple infectious conditions within primary care in the UK. The study also aims to idetify the rate of potentially inappropriate antibiotic prescribing over time;
defined as a deviation from two national prescribing guidelines (published 2017):
1) The National Institute for Health and Care Excellence (NICE)
2) Public Health England (PHE)
Product codes from The British National Formula will be used to identify antibiotics type at the point of prescribing. Should this prescription deviate from the national guidelines it will be defined as a potentially inappropriate choice of antibiotic. This informaiton will be displayed over time.
A multilevel logistic regression will also be used to identify which patient specific and practice specific exposures are key predictors of inappropriate prescribing. To determine any similarities or differences between practice prescribing habits, the proportion of variance that can be attributed to a clustering effect will be analysed by time (year) and practice level.
This work will highlight specific areas of antibiotic prescribing that may need improving and better educating a targeted intervention for antimicrobial stewardship programmes in the UK.
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Understanding the physical harms associated with the use of combined antipsychotic medication in people with schizophrenia — Sarah Sullivan ...
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Understanding the physical harms associated with the use of combined antipsychotic medication in people with schizophrenia
Datasets:GP data, HES Admitted Patient Care; Mental Health Services Data Set (MHSDS); Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-08
Organisations:
Sarah Sullivan - Chief Investigator - University of Bristol
Theresa Redaniel - Corresponding Applicant - University of Bristol
Blanca Bolea - Collaborator - University of Toronto
David Kessler - Collaborator - University of Bristol
Emily Catherine Eyles - Collaborator - University of Bristol
Hannah Edwards - Collaborator - University of Bristol
Jelena Savovic - Collaborator - University of Bristol
Manjula Nugawela - Collaborator - University College London ( UCL )
Sharea Ijaz - Collaborator - University of Bristol
Simon Davies - Collaborator - University of TorontoOutcomes:
Prescription of a medication for hypertension, diabetes or hypercholesterolemia during follow-up
- A READ code diagnosis of hypertension, diabetes, hypercholesterolemia
- An ICD-10 code for hypertension, diabetes, hypercholesterolemiaDescription: Technical Summary
People with schizophrenia are more likely to suffer from serious physical conditions i.e. diabetes, hypertension and hypercholesterolaemia. This study aims to investigate the prospective association between antipsychotic polypharmacy and diabetes, hypertension and hypercholesterolemia and to investigate the mechanism of any association.
Using the Clinical Practice Research Datalink (CPRD), we will conduct a retrospective cohort study of schizophrenia patients who are: registered with a participating GP practice and prescribed 1 antipsychotic medication at study entry.
The outcome is the incidence of diabetes, hypertension and hypercholesterolaemia. This will be defined as having a prescription of an antihypertensive, cholesterol-lowering and/or anti-diabetic drug (primary outcome) or having a prescription and an ICD10 code or a READ code for diabetes, hypertension or hypercholesterolaemia (secondary outcome). We will follow patients up for 15 years or until a diagnosis of or prescription for an outcome, transfer out of the surgery, last record of up-to-standard contact, absence of new prescriptions for anti-psychotic medication or death.
We will use marginal structural models to investigate the association between time-exposed to anti-psychotic polypharmacy (APPP) and prescription of an outcome medication. Least Angle Regression will be used to investigate competing hypotheses for an association.
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5-ASA in Crohn's Disease: The CROHN'S Investigation (Clinical and treatment Resource use, patient Outcomes and Health impact using National prescribing Systems) — John Fullarton ...
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5-ASA in Crohn's Disease: The CROHN'S Investigation (Clinical and treatment Resource use, patient Outcomes and Health impact using National prescribing Systems)
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-25
Organisations:
John Fullarton - Chief Investigator - Strategen
Barry Rodgers-Gray - Corresponding Applicant - Strategen
James Edwards - Collaborator - Strategen
John Watkins - Collaborator - UWCM - University of Wales College of Medicine
Scot Buchan - Collaborator - StrategenOutcomes:
Continuation rates on 5-ASA, e.g. 1, 2, 3, 5, 10 years
Treatment/prescribing patterns of 5-ASA in primary care, e.g. treatment Resource utilisation, e.g. primary care visits, hospitalisations, surgery, diagnostic and monitoring procedures, laboratory tests, drug costs
Patient reported outcomes (if available)Description: Technical Summary
This is an observational, retrospective, database investigation to identify and assess pharmaceutical prescribing patterns, healthcare resource utilisation, management practices, patient types, and patient outcomes for adult patients (more than or equal to 18 years) diagnosed with Crohn's disease (CD) treated with 5-aminosalicylic acid (5-ASA). Data will be collected from anonymised records over a period from 2006 to the present day (date the data are extracted from the database). The following key areas will be investigated: 1) Continuation rates for use of 5-ASAs in patients with CD (including: baseline and subsequent treatment patterns; continuation rates at 1 year, 2 years, 5 years, and 10 years; treatment switch/change; add-on treatment, including corticosteroids; and dose optimisation of treatment); and, 2) Resource utilisation of patients treated with 5-ASAs (including: visits to primary care [total and CD-related, if available] and specialist consultant [for CD]; hospitalisations; surgery; diagnostic and monitoring procedures, e.g. endoscopy, ultrasound, biopsy, etc.; laboratory tests, e.g. blood, stool, etc.; and drug costs).
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Mapping opportunities for earlier detection of Bipolar Disorder - Linking big data to improve patient outcomes (MOBILISE) — Darren Ashcroft ...
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Mapping opportunities for earlier detection of Bipolar Disorder - Linking big data to improve patient outcomes (MOBILISE)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-24
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Cathy Morgan - Corresponding Applicant - University of Manchester
Alison Yung - Collaborator - University of Manchester
Andy Brass - Collaborator - University of Manchester
Anya Francis - Collaborator - University of Manchester
Carolyn Chew-Graham - Collaborator - Keele University
DAVID JENKINS - Collaborator - University of Manchester
Matthew Sperrin - Collaborator - University of ManchesterOutcomes:
Bipolar disorder
Cancer morbidity
Unnatural deaths
Self-harm
Diabetes mellitus morbidity
Alcohol-specific deaths
Major cardiovascular event
All-cause mortality
Cancer deaths
Cardiovascular deathsDescription: Technical Summary
The study objectives are to improve early recognition of Bipolar Disorder (BD), examine major adverse outcomes as a consequence of BD and to examine risk factors for delayed diagnosis and the consequences of delay. Individuals with first diagnosis of BD, identified by Read codes between 1/1/2010 and 31/07/2017 in CPRD and eligible for IMD, HES and ONS-linkage will be extracted and matched on age, gender, practice and index date with unaffected control patients (ratio 1:20). Likely symptoms of onset and those earlier signs leading up to onset will be identified by investigating the incidence of each event of interest for each year prior to diagnosis from all contacts through primary and secondary care sources of individuals with and without BD. A separate analysis using machine learning, which identifies patterns of events without prior knowledge of associated symptoms will also be adopted. To handle the large number of event codes and with some codes very rarely used, semantic similarity and principal component analysis will be applied. In addition, density-based spatial clustering of applications with noise (DBSCAN) algorithm to identify clusters of patients exhibiting similar patterns will be implemented. Cox regression will be used to investigate whether individuals with BD have elevated morbidity and mortality risk. By establishing the likely onset date of BD and calculating the probable diagnosis delay, multivariable regression models (linear or logistic regression) will be used to identify factors independently associated with diagnosis delay such as subsequent mental health diagnoses or substance abuse. We will also examine elevated risk between delayed diagnosis and subsequent morbidity and mortality outcome by using Cox regression analysis to obtain hazard ratios.
Source - and 26 more projects — click to show
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Meeting the physical healthcare needs of people with serious mental illness in primary care — Kate Bosanquet ...
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Meeting the physical healthcare needs of people with serious mental illness in primary care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-17
Organisations:
Kate Bosanquet - Chief Investigator - University of York
Kate Bosanquet - Corresponding Applicant - University of York
Ceri Owen - Collaborator - Service User of MHLDDS
David Shiers - Collaborator - University of York
Ian Watt - Collaborator - University of York
Kenan Direk - Collaborator - University College London ( UCL )
Lu Han - Collaborator - University of York
Peter Coventry - Collaborator - University of York
Rowena Jacobs - Collaborator - University of York
Shehzad Ali - Collaborator - University of York
Simon Gilbody - Collaborator - University of York
Tim Doran - Collaborator - University of YorkOutcomes:
Admitted Patient Care
Cholesterol levels
Blood pressure
Accident & Emergency attendance
Diabetes status
Glucose levels
HbA1c levels
BMI
MortalityDescription: Technical Summary
People with serious mental illness (SMI) have reduced life expectancy and are at increased risk of comorbidities compared to the general population. Unmet physical health need is increasingly recognised as one of the factors underpinning the morbidity-mortality gap. Since its inception in 2004, the Quality and Outcomes Framework (QOF) offered general practices in England incentives to conduct physical health checks on patients with SMI to address this inequality. In 2014, however, all indicators rewarding physical health checks were retired - with the exception of blood pressure. This project aims to examine the impact of incentives for physical checks on quality of care and health outcomes for SMI patients.
Data routinely collected from CPRD, linked to HES and ONS, and a technique called an Interrupted Time Series Analysis will be used to assess the impact of national guidelines and incentives on clinical activity in primary care, unplanned hospital admissions and deaths of SMI patients. Using this approach any change/trend in clinical activity, admissions and deaths due to the introduction and/or retirement of incentives will be identified.
Findings will be disseminated to a wide range of audiences and used to inform policy recommendations on how to reduce the morbidity-mortality gap associated with SMI.
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Comparison of Outcomes for Patients Hospitalised for Heart Failure (HHF) in the UK, Japan, USA and Taiwan — Jennifer Quint ...
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Comparison of Outcomes for Patients Hospitalised for Heart Failure (HHF) in the UK, Japan, USA and Taiwan
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-04
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Varun Sundaram - Corresponding Applicant - Imperial College London
Claudia Gulea - Collaborator - Imperial College London
Toshiyuki Nagai - Collaborator - Imperial College LondonOutcomes:
All-cause mortality
Length of hospital stay
30 day readmissions
Health care resource utilizationDescription: Technical Summary
As a national sample of current practice, we will use linked Clinical Practice Research Datalink (CPRD) data with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) to undertake a cohort study to provide an accurate estimate of the number of people with hospitalised heart failure in the United Kingdom (UK). Japanese data will be sourced from the 2012-2015 Nationwide Claim-Based Database, the Japanese Registry Of All cardiac and vascular Diseases - Diagnosis Procedure Combination (JROAD-DPC), US data from the National Inpatient Sampling Database and Taiwan data from National Health Insurance Research Database -NHIRD. Each cohort (UK, USA, Japan and Taiwan) will be analysed separately. All-cause mortality, length of hospital and health care resource utilisation will be analysed in each dataset. On completion of the analysis, pooled estimates will be compared across the datasets.
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Gabapentinoid drug prescriptions in patients with osteoarthritis: an analysis of data from the Clinical Practice Research Datalink — George Peat ...
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Gabapentinoid drug prescriptions in patients with osteoarthritis: an analysis of data from the Clinical Practice Research Datalink
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-04
Organisations:
George Peat - Chief Investigator - Keele University
Dahai Yu - Collaborator - Keele University
John Bedson - Collaborator - Keele University
Julie Ashworth - Collaborator - Keele University
Thomas Appleyard - Collaborator - Keele UniversityOutcomes:
Health outcome = recorded prescription of gabapentinoids (code lists derived from6) (Appendix 4)
Description: Technical Summary
OA is a common, painful, disabling condition leading to a million GP consultations in the UK each year. There is anecdotal evidence that gabapentinoids such as gabapentin and pregabalin are being used in patients with OA. Licensed for neuropathic pain, their possible usage in OA patients may be due to concerns with current options, but also literature suggesting some OA patients have a neuropathic element to their pain. There is, however, little evidence that gabapentinoids are effective for OA pain and they are not mentioned in current clinical practice guidelines for OA. The UK government is now intending to reclassify these dependence-forming medicines as class C controlled substances.
Our study aims to describe the patterns and trends in gabapentinoid prescriptions in patients with OA. A secondary objective is to conduct a simple before-after study to describe gabapentinoid prescriptions before and after primary total knee replacement, a highly effective treatment for end-stage knee OA. This should help us further understand gabapentinoids may be getting prescribed independently of the severity of OA pain.
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Heart failure as a risk factor for acute exacerbations of COPD (AECOPD) — Jennifer Quint ...
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Heart failure as a risk factor for acute exacerbations of COPD (AECOPD)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-02
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Eleanor Axson - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Chloe Bloom - Collaborator - Imperial College London
Martin Cowie - Collaborator - King's College London (KCL)
Varun Sundaram - Collaborator - Imperial College LondonOutcomes:
Incidence of comorbid COPD and HF
 Prevalence of comorbid COPD and HF
 Rates of AECOPD in relation to comorbid COPD-HFDescription: Technical Summary
Heart failure and chronic obstructive pulmonary disease (COPD) share aetiology, symptoms, and the potential to exacerbate the other condition leading to higher health care utilization costs and mortality in patients with both conditions. Recent international guidelines have recommended increased consideration of comorbid conditions when assessing COPD and heart failure, demonstrating recognition of the influences of comorbidities on disease progression and prognosis. In this study, we will investigate the incidence of comorbid COPD and heart failure, the effect of comorbid heart failure on acute exacerbations of COPD (AECOPD), and the impact of suboptimal treatment and under-diagnosis of heart failure on AECOPD. This is a cohort study and will calculate incidence and prevalence. Survival analysis (Cox regression) will be used to investigate delayed HF diagnosis and matched cohort analysis (Cox) will be used to compare AECOPD across patient groups.
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with coronary artery disease (CAD), peripheral artery disease (PAD), and CAD or PAD — Jennifer Quint ...
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with coronary artery disease (CAD), peripheral artery disease (PAD), and CAD or PAD
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-04
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Varun Sundaram - Corresponding Applicant - Imperial College London
Alexander Cohen - Collaborator - King's College London (KCL)
Amitava Banerjee - Collaborator - University College London ( UCL )
Jean Baptiste Briere - Collaborator - Bayer AG
Julian Halcox - Collaborator - Swansea UniversityOutcomes:
Incidence and prevalence of coronary artery disease (CAD), peripheral artery disease (PAD), and CAD and PAD
Risk and incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CAD, PAD, and CAD and PAD
Health resource utilisation (HRU) related to CAD and PAD complications in patients with CAD, PAD, and CAD and PAD
Treatment patterns (with a focus on standard of care) in patients with CAD, PAD, and CAD and PAD
Risk/incidence of complications for CAD and PAD, HRU for CAD and Pad complications, and treatment patterns for key sub-populations of patients with CAD, PAD, and CAD and PADDescription: Technical Summary
This is a cohort study with the overall objective of gaining a better understanding of the epidemiology, disease course, health resource utilisation (HRU), and treatment patterns of real-world patients with coronary artery disease (CAD), peripheral artery disease (PAD), and patients with CAD or PAD. The specific aims of the study are:
- To estimate the incidence and prevalence of CAD, PAD, and CAD or PAD
- To describe demographic and clinical characteristics of patients with CAD, PAD, and CAD or PAD
- To estimate the risk/incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CAD, PAD, and CAD or PAD
- To describe HRU related to CAD and PAD complications among patients with CAD, PAD and CAD or PAD
- To describe treatment patterns, with a focus on standard of care, among patients with CAD, PAD, and CAD or PAD
- To estimate the risk/incidence of complications, compare the risk of complications, describe HRU related to CAD and PAD complications, and describe treatment patterns among subgroups of patients with CAD, PAD, and CAD or PAD defined by demographics, medical history, prior procedures, medication use, and risk scores.The study will be undertaken utilizing linked data within the Clinical Practice Research Database and Hospital Episode Statistics database. The study time frame will be 1, January 2006 to December 31st, 2016
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Are improvements in chronic respiratory disease management in England associated with reductions in excess mortality? — Jennifer Quint ...
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Are improvements in chronic respiratory disease management in England associated with reductions in excess mortality?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-25
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Alicia Gayle - Corresponding Applicant - Imperial College LondonOutcomes:
COPD exacerbation rate per 100 patients
 Asthma attack rate per 100 patients
 % COPD patients prescribed oral steroid
 Hospitalisation rate per 100 patients
 Excess mortality rateDescription: Technical Summary
Asthma and Chronic Obstructive Pulmonary Disease (COPD) continue to be an important cause of morbidity, mortality, and health-care costs in the United Kingdom (UK). Improvements in disease management in primary care over the last 20 years have widely been attributed to incentive-driven activities in addition to better treatments and earlier diagnosis. However whether these changes are related to the excess risk of death among respiratory disease patients has yet to be investigated. This cohort study, using linked CPRD, HES and ONS data, aims to understand whether there is an association between trends in common disease management metrics, outcomes and excess mortality rates among patients with COPD, Asthma or both. Interrupted time series analysis will be used to understand which major interventions are related to trends and a multilevel regression model for excess mortality rates will be used to quantify the association between disease management achievements, outcomes and excess mortality in these three populations.
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Management of hyperthyroidism in pregnancy; data from a large UK primary care cohort — Caroline Minassian ...
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Management of hyperthyroidism in pregnancy; data from a large UK primary care cohort
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-19
Organisations:
Caroline Minassian - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Bijay Vaidya - Collaborator - University of Exeter
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Onyebuchi Okosieme - Collaborator - Cardiff University
Peter Taylor - Collaborator - Cardiff University
Sara Thomas - Collaborator - Not from an Organisation
William Hamilton - Collaborator - University of ExeterOutcomes:
Thyroid status during pregnancy
Description: Technical Summary
Hyperthyroidism is common in women of childbearing age and is associated with adverse pregnancy and neonatal outcomes; optimal treatment is therefore vital. However, there are concerns surrounding the adequacy of its management in pregnancy and the safety of the two main antithyroid drugs (carbimazole and propylthiouracil). Current guidelines recommend a combination approach: propylthiouracil in the first trimester, to avoid potential teratogenicity with carbimazole, then changing to carbimazole to avoid potential propylthiouracil-induced liver damage. Definitive treatment of hyperthyroidism (with radioiodine or thyroidectomy) before pregnancy is also recommended as an alternative to antithyroid drug treatment. However, data on guideline adherence and adequacy of thyroid control in pregnant women with hyperthyroidism in the UK are lacking. We will undertake a descriptive analysis of trends in UK management of hyperthyroidism before and during pregnancy since 2001. Using a cohort design and multivariable logistic regression we will then assess whether definitive treatment before pregnancy results in better thyroid status during pregnancy (defined by thyroid-stimulating hormone and free thyroxine levels within UK reference ranges). We will also assess whether the combination drug approach results in a deterioration of thyroid status. The findings will be key to optimising treatment strategies for hyperthyroidism before and during pregnancy.
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Mapping the Multimorbidity Burden in Patients with Type-2 Diabetes Mellitus and Coronary Heart Disease — Evangelos Kontopantelis ...
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Mapping the Multimorbidity Burden in Patients with Type-2 Diabetes Mellitus and Coronary Heart Disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-19
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Magdalena Nowokowska - Corresponding Applicant - Farr Institute of Health Informatics Research
Christian Mallen - Collaborator - Keele University
Darren Ashcroft - Collaborator - University of Manchester
Mamas Mamas - Collaborator - Keele University
Salwa Zghebi - Collaborator - University of Manchester
Stephen Weng - Collaborator - University of NottinghamOutcomes:
Percentage of T2DM/CHD patients with individual comorbidities and pairs of comorbidities at the time of T2DM/CHD diagnosis and after the follow-up period.
 Expected prevalence for 2020 and 2030
 Percentage of patients diagnosed with T2DM/CHD in a given year between 2007 and 2017 who also had comorbidity
 All-cause and index disease related death within 12 month of the T2DM/CHD diagnosis
 All-cause and index disease-related hospitalisation within 12 months of the T2DM/CHD diagnosisDescription: Technical Summary
Most patients with type-2 diabetes mellitus (T2DM) and coronary heart disease (CHD) have comorbidities; however, research has predominantly focused on single conditions, rather than multimorbidity. There are various multimorbidity measures available, all capturing different aspect of multimorbidity burden. Using primary care data from Clinical Practice Research Datalink, we aim to identify patterns of multimorbidity in patients with T2DM and CHD as measured by different available multimorbidity scores including the 1) total count of 16 chronic conditions included in the Quality and Outcome Framework (QOF), 2) Charlson Comorbidity Index (CCI) 3) electronic Frailty Index (eFI) 4) a Diabetes Severity Score, currently under development.
We will identify patients diagnosed with T2DM or CHD between 2007 and 2017. Based on Read/ICD10 codes and prescription data, we will identify the presence of individual conditions and calculate the prevalence rates and multimorbidity measures in patients stratified by gender, age and deprivation. We will estimate how patients of different characteristics perform on these measures. Furthermore, we will use machine learning methods to 1) Identify groups of similar conditions and 2) Create an algorithm predicting death and hospitalisation of T2DM/CHD patients and identify variables most important in predicting these outcomes.
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Mortality and morbidity effects of long-term exposure to low-level PM2.5, Black Carbon, NO2 and O3: an analysis of European cohorts — Richard Atkinson ...
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Mortality and morbidity effects of long-term exposure to low-level PM2.5, Black Carbon, NO2 and O3: an analysis of European cohorts
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-29
Organisations:
Richard Atkinson - Chief Investigator - St George's, University of London
Richard Atkinson - Corresponding Applicant - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
John Gulliver - Collaborator - Imperial College LondonOutcomes:
Mortality
- Coronary and cerebrovascular disease incidence
- Lung cancer incidence
- Dementia incidence
- Diabetes mortalityDescription: Technical Summary
The objective of this study, part of a European-wide multi-centre project, is to investigate associations between long-term concentrations of outdoor air pollution and health, with particular focus on the shape of the concentration-response relationship at low pollutant concentrations. If associations are observed at low levels, then these findings will have important implications for public health because of the very large populations exposed. Concentrations of fine particles, black carbon, nitrogen dioxide, ozone and vehicular non-tailpipe pollution (Cu, Fe, Zn) and secondary inorganic aerosol will be estimated at 100m grid resolution across England for 2010 using statistically derived (land use regression) models and satellite monitoring. Using patients registered in CPRD throughout 2010, all disease related and cardiorespiratory deaths and incident cardiovascular, dementia and lung cancer during 2011-2017 will be determined from primary care, hospital admissions and death records. Cox proportional hazard models controlling for age, gender, BMI, smoking status and socioeconomic status will be used to estimate the hazard associated with pollutant concentrations. The shape of the concentration response function will be assessed using non-parametric spline functions. The hazard ratios will be combined with those from the other cohorts in the project in an European-wide meta-analyses to improve precision of the effect estimates.
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Prescription medications for cardiovascular disease and metabolic syndrome and risk of endometrial and ovarian cancer in the Clinical Practice Research Datalink — Nicolas Wentzensen ...
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Prescription medications for cardiovascular disease and metabolic syndrome and risk of endometrial and ovarian cancer in the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-19
Organisations:
Nicolas Wentzensen - Chief Investigator - National Cancer Institute ( NCI )
Megan Clarke - Corresponding Applicant - National Cancer Institute ( NCI )
Britton Trabert - Collaborator - National Cancer Institute ( NCI )
Kara Michels - Collaborator - National Cancer Institute ( NCI )
Marie Bradley - Collaborator - Food and Drug Administration - FDA
Ruth Pfeiffer - Collaborator - National Cancer Institute ( NCI )
Sarah Irvin - Collaborator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Collaborator - National Cancer Institute ( NCI )
Tamara Litwin - Collaborator - National Cancer Institute ( NCI )Outcomes:
Endometrial Cancer
⢠Ovarian CancerDescription: Technical Summary
Endometrial cancer is the most common gynaecological cancer among women in the U.K., with 9,000 cases, and 2,200 deaths in 2014. Though less common, ovarian cancer is the deadliest gynaecological cancer, with 7,284 cases and 4,128 deaths estimated in 20142. Obesity and related metabolic conditions such as insulin resistance, hypertension, and dyslipidaemia are risk factors for endometrial cancer, and may also be associated with certain types of ovarian cancer. Mechanisms underlying these associations may involve perturbations in several biological pathways, including sex steroid hormone, insulin and insulin-like growth factor (IGF-1), and pro-inflammatory cytokine (e.g., tumour necrosis factor alpha (TNFα) and interleukin-6 (IL-6)) signaling. Pharmacologic antagonism of these pathways may have unanticipated beneficial effects in relation to endometrial and ovarian carcinogenesis. This hypothesis has led to growing interest in evaluating (i.e., ârepositioningâ) these medications, with the goal of identifying novel molecular targets for pharmacological interventions. We propose to investigate the associations of common medications prescribed to treat metabolic conditions and cardiovascular disease, specifically: statins, metformin, non-selective beta-blockers, and cardiac glycosides, with risk of endometrial and ovarian cancer in a large, longitudinal primary care database known for highly accurate and complete diagnostic and drug prescribing data.
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Blood Eosinophil Levels and Severe Asthma Exacerbations Among Paediatric Patients with Asthma in the English Primary Care Setting — Melissa Van Dyke ...
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Blood Eosinophil Levels and Severe Asthma Exacerbations Among Paediatric Patients with Asthma in the English Primary Care Setting
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-25
Organisations:
Melissa Van Dyke - Chief Investigator - GSK
Mugdha Gokhale - Corresponding Applicant - GlaxoSmithKline - UK
Lee Evitt - Collaborator - GSK
Sarah Rabhi - Collaborator - Not from an Organisation
Takako Hattori - Collaborator - GSKOutcomes:
Asthma exacerbations (i.e., asthma-related general practitioner (GP)/hospital visits)
- asthma-related healthcare resource utilization
- asthma treatmentsDescription: Technical Summary
Asthma-related exacerbations remain a significant burden on the healthcare system and can be described as an acute episode of progressively worsening shortness of breath, wheezing, and chest tightness that results in decreased lung function.1 A severe asthma exacerbation can be defined as: (1) treatment with an initial or increased dose of OCS, (2) an accident and emergency department (A&E) visit, and/or (3) a hospital admission.2 Eosinophilic asthma, recognisable due to its increased levels of blood eosinophils, has been associated with diminished lung function, airway inflammation, uncontrolled symptoms, and higher amounts of exacerbations than non-eosinophilic asthma.3,4 Evidence suggests that the association between increased eosinophils and more numerous exacerbations may be even more apparent in paediatric patients than in adults.5 The current study will describe the background epidemiology and health care utilization in the four paediatric (aged 6-17 years) asthma cohorts in terms of medications, blood eosinophil levels, and/or frequency of severe asthma exacerbations.
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with Congestive heart failure (CHF), and patients with CAD and CHF — Jennifer Quint ...
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with Congestive heart failure (CHF), and patients with CAD and CHF
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-04
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Varun Sundaram - Corresponding Applicant - Imperial College London
Alexander Cohen - Collaborator - King's College London (KCL)
Amitava Banerjee - Collaborator - University College London ( UCL )
Jean Baptiste Briere - Collaborator - Bayer AG
Julian Halcox - Collaborator - Swansea UniversityOutcomes:
Incidence and prevalence of coronary artery disease (CAD), peripheral artery disease (PAD), and CAD and PAD.
Risk and incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CAD, PAD, and CAD and PAD
Health resource utilisation (HRU) related to CAD and PAD complications in patients with CAD, PAD, and CAD and PAD
Treatment patterns (with a focus on standard of care) in patients with CAD, PAD, and CAD and PAD
Risk/incidence of complications for CAD and PAD, HRU for CAD and Pad complications, and treatment patterns for key sub-populations of patients with CAD, PAD, and CAD and PADDescription: Technical Summary
This is a cohort study with the overall objective of gaining a better understanding of the epidemiology, disease course, health resource utilisation (HRU), and treatment patterns of real-world patients with Chronic heart failure (CHF), and patients with CAD and CHF. The specific aims of the study are:
- To estimate the incidence and prevalence of CHF, CAD and CHF
- To describe demographic and clinical characteristics of patients with CHF, and patients with CAD and CHF
- To estimate the risk/incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CHF, CAD and CHF
- To describe HRU related to CAD and CHF complications among patients with CHF, CAD and CHF
- To describe treatment patterns, with a focus on standard of care, among patients with CHF and patients with CAD and CHF
- To estimate the risk/incidence of complications, compare the risk of complications, describe HRU related to CHF and CAD/CHF complications, and describe treatment patterns among subgroups of patients with CHF, and patients with CAD and CHF defined by demographics, medical history, prior procedures, medication use, and risk scores.The study will be undertaken utilizing linked data within the Clinical Practice Research Database and Hospital Episode Statistics database. The study time frame will be 1 January 2006 to the most recent data available.
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Pharmaco-Epidemiological Study of Cardio-Respiratory Safety of Beta2-agonists for the Treatment and Management of Asthma-COPD Overlap Syndrome — Zhiwei Gao ...
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Pharmaco-Epidemiological Study of Cardio-Respiratory Safety of Beta2-agonists for the Treatment and Management of Asthma-COPD Overlap Syndrome
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-17
Organisations:
Zhiwei Gao - Chief Investigator - Memorial University of Newfoundland ( MUN )
Joseph Amegadzie - Corresponding Applicant - Memorial University of Newfoundland ( MUN )
Jamie Farrell - Collaborator - Memorial University of Newfoundland ( MUN )
JM Gamble - Collaborator - University Of Waterloo
William K. Midodzi - Collaborator - Memorial University of Newfoundland ( MUN )Outcomes:
Outcomes: Our primary endpoints of interest are 1) all-cause mortality 2) pneumonia and 3) major adverse cardiovascular events. Pneumonia and major adverse cardiovascular events will consist of a diagnosis recorded in the GOLD data or HES data. Since mortality outcomes are only available in the subcohort data linked to ONS (death certificate), we will use this linked subcohort to assess cause-specific mortality for pneumonia and cardiovascular mortality. Major adverse cardiovascular events will be defined as the first occurrence of non-fatal MI, non-fatal stroke, heart failure, arrhythmia or any cardiovascular-related mortality. Outcome assessment of cardiovascular-related admissions and mortality will be based on READ codes contained in the GOLD data linked to the sub-cohort of ICD-10 codes in the HES/ONS data (see Appendix D for codes). These outcomes definition were based on validated READ codes in the CPRD data and ICD-10 codes in the HES or ONS linkage data.[48-50]. Our research will utilize the full study cohort identified from the GOLD database to maximize precision.
Description: Technical Summary
To date, there are no published observational studies which have examined the association between Beta2-agonist medications and the risk of Cardio-Respiratory (CR) events in patients with Asthma-COPD Overlap Syndrome, ACOS. To address these limitations and knowledge gap, this research proposes to use an existing database of detailed healthcare records of new-users of bronchodilator medications for patients with physician diagnosed asthma and COPD. In particular, the impact of CR outcomes /events which include all-cause-mortality, pneumonia and major adverse cardiovascular events (including non-fatal myocardial infarction (MI), non-fatal stroke, heart failure (HF), arrhythmia or cardiovascular mortality) in patient with ACOS would be assessed and the results from this proposed study will represent the first and novel findings.
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Using Predictive Analytics to Improve Patient Outcomes in Neuroendocrine Tumours — Ruby Saharan ...
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Using Predictive Analytics to Improve Patient Outcomes in Neuroendocrine Tumours
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-26
Organisations:
Ruby Saharan - Chief Investigator - NOVARTIS
Paul McGettigan - Corresponding Applicant - Novartis Ireland Limited
Ailis Fagan - Collaborator - NOVARTIS
Jamie Weaver - Collaborator - The Christie NHS Foundation Trust
Martin McSharry - Collaborator - Optum
Spyros Roumpanis - Collaborator - F. Hoffmann - La Roche Ltd
Wasat Mansoor - Collaborator - The Christie NHS Foundation TrustOutcomes:
Primary: 5 year survival from NETs diagnosis
Description: Technical Summary
The objective of this study is to identify predictors of survival in the five year follow-up period after the initial diagnosis of Neuroendocrine tumours (NETs).
This is a retrospective cohort study utilizing data from CPRD linked to Hospital Episode statistics (HES), UK Cancer Registry databases and Office for National Statistics (ONS) mortality data.The study cohort will be followed for the 5 year period from initial diagnosis. Predictors of survival will be identified using machine learning algorithms based on patient's characteristics. Patient subgroups, treatment pathways and diagnosis pathways will be identified using clustering.
Descriptive statistics will be produced on patient characteristics at baseline and treatment pathways in the post-index period.
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Improving care and cardiovascular health status for adults with osteoarthritis at risk of cardiovascular disease — Dahai Yu ...
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Improving care and cardiovascular health status for adults with osteoarthritis at risk of cardiovascular disease
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-02
Organisations:
Dahai Yu - Chief Investigator - Keele University
Dahai Yu - Corresponding Applicant - Keele University
Mamas Mamas - Collaborator - Keele University
Ross Wilkie - Collaborator - Keele University
Xiaoyang Huang - Collaborator - Keele UniversityOutcomes:
i) Outcomes for Stage I: Longitudinal descriptive study:
1) CV risk factors (smoking, hypertension, type 2 diabetes, overweight or obesity, dyslipidaemia) recorded in primary care settings (Appendix 3-5)2) Management of CV risk factors (proportion of taking antihypertensive prescriptions, proportion of taking lipid lowering prescriptions, proportion of taking anti-diabetic prescriptions and frequency of blood test)
ii) Outcomes for Stage II: Cohort study
1) Incident diagnosed CVDs recorded in primary care settings
2) Mortality due to CVDs
3) Specific group of CVDs (Ischaemic heart disease, heart failure, cerebrovascular disease, and peripheral vascular disease)
Description: Technical Summary
The objective of the proposed research is to test the hypotheses that people with osteoarthritis, compared to those without, have a higher risk profile for cardiovascular disease (CVD), have an earlier presentation of CVD, are less likely to receive treatment in line with preventative treatment guidelines, and have increased health care needs.
This is a longitudinal cohort study of adults aged 35 and over with and without osteoarthritis. Descriptive statistics will be used to describe the prevalence of cardiovascular risk factors (smoking, hypertension, type 2 diabetes, overweight or obesity, dyslipidaemia) and frequency of the management (e.g whether prescribed antihypertensive, lipid lowering and anti-diabetic medication, frequency of blood tests) to determine whether this is in line with existing primary care guidelines. Cox proportional hazards modelling will be used to estimate (i) the lifetime risk of CVD, and (ii) the association between CV risk factors and the lifetime risk of CVD (adjusting for confounders) in those with and without osteoarthritis. Model performance will be evaluated using Bayesian Information Criterion (for goodness of fit), BrierÂs score and the Calibration slope (for model calibration) and C Statistics (for discrimination).
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REPEAT: Study 9- Replication of "Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischaemic heart disease: a cohort study with nested case-control analysis" — Shirley Wang ...
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REPEAT: Study 9- Replication of "Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischaemic heart disease: a cohort study with nested case-control analysis"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-02
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
All-cause mortality, identified through a record of death in the CPRD.
Description: Technical Summary
This objective of this protocol is to replicate the study: "Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischemic heart disease: a cohort study with nested case-control analysis" by Reeves et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review.
The Reeves paper conducts a validation of a research study using a different electronic health record database than CPRD. We will focus on replicating the outcome of all-cause mortality of patients with ischemic heart disease on statin medication. Mortality will be identified by a record of death in the CPRD. A Cox proportional hazards model with time varying exposure to statins will be used to examine the effect of statin use on patient survival.
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The epidemiology and healthcare burden of opioid therapy in the United Kingdom — Craig Currie ...
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The epidemiology and healthcare burden of opioid therapy in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-29
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Treatment patterns of opioid therapy in primary care
- Demographic and clinical characteristics of patients exposed to opioid therapy
- Patient-level and treatment characteristics that may modify healthcare resource use and cost
- Annual incidence and prevalence of opioid therapy
- Number and financial costs of primary and secondary healthcare contacts and prescribed medications while exposed to opioid therapy
- Adverse events associated with opioid exposure and their treatmentDescription: Technical Summary
Recent years have seen a significant increase in opioid prescribing in the UK and elsewhere, with consequent concerns about healthcare burden. We wish to profile the prescribing of weak and strong opioids in UK primary care 1998-2016 and to examine the impact of treatment patterns, indications and adverse events on healthcare resource use and associated cost. Episodes of opioid treatment will be identified from prescription data and characterized by their indications, component opioid class(es), duration, medical possession ratio, number of treatment changes, adverse events commonly associated with opioids, and the stability of the treatments for those adverse events. We will report the annual incidence and prevalence of opioid therapy and calculate the frequency and associated costs of healthcare use in the course of the episode, comparing these with usage and costs in the 12 months prior to initiation using the Wilcoxon signed-rank testPoisson regression models, and stratifying the results by the episode characteristics described above. Main analyses will consider primary-care data from CPRD alone, with sensitivity analyses performed with the addition of linked inpatient and outpatient data in patients eligible for linkage.
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Cessation of renin-angiotensin system inhibitors after acute kidney injury and outcome — Laurie Tomlinson ...
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Cessation of renin-angiotensin system inhibitors after acute kidney injury and outcome
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-17
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Clémence Leyrat - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Edward Kingdon - Collaborator - Royal Sussex County Hospital
Erick Wafula Mugoma - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Fontini Kalogirou - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kate McAllister - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Samantha Wilkinson - Collaborator - Roche
Viyaasan Mahalingasivam - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Odds of continued prescription of an ACE Inhibitor or Angiotensin receptor blocker (primary descriptive outcome)
Odds of continued prescription of an ACE Inhibitor or Angiotensin receptor blocker (primary descriptive outcome)Description: Technical Summary
Due to concern about the association between ACE inhibitors (ACEI) and angiotensin receptor blockers (ARBs), and acute kidney injury (AKI), it is thought that a growing proportion of people are having their medication stopped. It is not known if the potential benefits of reducing future AKI risk from stopping ACEI/ARB outweigh an increased risk of admission from other causes. To address this, we will identify a cohort of users of ACEI/ARBs who are admitted to hospital with AKI. We will identify the proportion of these who are represcribed the drugs after admission and examine whether this is changing over time. We will describe total subsequent frequency of readmissions and length of hospital stay. Using poisson regression and adjusting for multiple confounders we will compare the rates of admission with: i) heart failure; ii) AKI; and iii) stroke, between those who do and do not restart an ACEI/ARB following first AKI admission. We will examine whether there is an interaction for the outcome between patients with and without a diagnosis of cardiac failure prior to the AKI admission.
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Health care use and cost trajectories of people in the last year of life : improving planning and resource allocation in end of life care — Joachim Marti ...
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Health care use and cost trajectories of people in the last year of life : improving planning and resource allocation in end of life care
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-29
Organisations:
Joachim Marti - Chief Investigator - Imperial College London
Joachim Marti - Corresponding Applicant - Imperial College London
Ara Darzi - Collaborator - Imperial College London
Elias Mossialos - Collaborator - Imperial College London
Martina Orlovic - Collaborator - Imperial College LondonOutcomes:
Health care resource use in the last 12 months of life (primary)
- Health care costs in the last 12 months of life
- Intensity of care at the end of life
- Appropriateness of care at the end of lifeDescription: Technical Summary
The aim of this study is to obtain a better understanding of the healthcare utilisation and health status trajectories in the last year of life and how this can be used to identify patient groups that are most likely to benefit from timely palliative care. We will first describe health status, resource use, and costs of patients in their last year of life using routinely collected linked data in a representative sample of the English population. The analysis will also aim to identify groups of patients with similar patterns of health care use and needs. This will be done using cluster analysis and latent class regression models, where each cluster/class will reflect similar trajectories of resource use or cost. The study will also seek to measure specific markers of care intensity (e.g. A&E admissions, days in ICU), appropriateness of care at the end of life, and transition probabilities between care settings. Finally, we will combine evidence from these descriptive analyses into a policy model aimed at measuring the potential efficiency gains from greater reliance on evidence-based end-of-life care.
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Trends in antipsychotic prescribing for children in UK primary care — Kathryn Abel ...
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Trends in antipsychotic prescribing for children in UK primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-17
Organisations:
Kathryn Abel - Chief Investigator - University of Manchester
Holly Hope - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Eleanor Swift - Collaborator - University of Manchester
Laszlo Trefan - Collaborator - University of Manchester
Matthias Pierce - Collaborator - University of Manchester
Nejla Cemre Su Osam - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
Changes in rates of antipsychotic prescriptions in children over time, measured by yearly incidence of prescriptions from 2000-2017
Overall prevalence of antipsychotic prescriptions in children between 2000 and 2017
Changes in the incidence of indications for antipsychotic prescriptions in children from 2000-2017
How prescription rates of first generation vs. second generation antipsychotics and the indications associated with them change in children from 2000-2017
How prescription rates of individual second generation antipsychotics and their indications change in children from 2000-2017
How yearly incidence of antipsychotic prescriptions and their indications in children from 2000-2017 varies according to gender, age and practice-level IMDDescription: Technical Summary
Evidence suggests that the rate of prescribing of psychotropic medication has increased among children and adolescents across Europe and the US since the 1990s; and that this pattern has also been seen with antipsychotics. However, we have limited data about trends in UK antipsychotic prescribing in children within the last five years; and we also have a limited understanding of the factors associated with these prescriptions.
This exploratory cohort study will use CPRD-Gold data to examine changes in antipsychotic prescription rates in 3 to 17 year olds from 2000 to 2017. It will examine the overall prevalence of antipsychotic prescribing amongst children and the rate of first antipsychotic prescriptions each year. Read codes for psychosis and other indications for antipsychotics will be identified and temporally linked to first antipsychotic prescriptions. We shall then examine changes in the rates of first generation antipsychotics (FGAs) vs. second generation antipsychotics (SGAs) and in individual SGAs. We shall also investigate changes in indications for these prescriptions over time and changes in rates of prescriptions in different ages, genders and socio-economic status.
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Identifying and Evaluating Modifiers of Subsequent Event Risk among Patients with Established Coronary Heart Disease — Riyaz Patel ...
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Identifying and Evaluating Modifiers of Subsequent Event Risk among Patients with Established Coronary Heart Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-19
Organisations:
Riyaz Patel - Chief Investigator - Barts Health and UCLH NHS Trusts
Riyaz Patel - Corresponding Applicant - Barts Health and UCLH NHS Trusts
Folkert Asselbergs - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Laura Pasea - Collaborator - University College London ( UCL )
Linghui Gong - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Myocardial infarction
- Unheralded coronary death
- Peripheral arterial disease
- Coronary revascularisation
- Heart failure
- Transient ischaemic attack
- Unstable angina
- Intracerebral haemorrhage
- Subarachnoid haemorrhage
- Ventricular arrhythmia or sudden cardiac death
- Peripheral arterial disease
- Abdominal aortic aneurysm
- Ischaemic or unspecified stroke
- All-cause mortality
- CHD cause of death
- CVD cause of deathDescription: Technical Summary
Among patients surviving their first coronary heart disease (CHD) event, risk of further cardiovascular events remains high. Modifiers of subsequent event risk are poorly understood, compared to those for a first CHD event in the general population. Understanding these modifiers has important implications for secondary prevention of CHD.
We hypothesise that (1) traditional cardiovascular risk factors may have different relationships for first and subsequent CHD events (2) there are novel and specific risk factors relevant for subsequent CHD events (3) non-cardiac drugs may have unrecognized benefits or harms for subsequent event risk and (4) this information could be combined to generate better risk modelling for use in patients with established CHD.
Using linked electronic health records, we will use Cox proportional hazards to model the associations between risk factors and first CHD and subsequent CHD events. Further Cox models will be used to estimate the associations between non-cardiac drugs and risk of subsequent CHD events, adjusted for propensity scores which model probability of treatment to limit confounding by indication bias. Multivariable logistic regression will be used to develop risk prediction models for subsequent events. In validation, C-indexes and Hosmer-Lemeshow tests will be used to assess the model discrimination and calibration.
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Utilisation of Ulipristal acetate 5mg, long-term treatment patterns, resource utilisation in a population-based cohort in UK using the THIN and CPRD databases — Renate Schulze...
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Utilisation of Ulipristal acetate 5mg, long-term treatment patterns, resource utilisation in a population-based cohort in UK using the THIN and CPRD databases
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Score; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-10
Organisations:
Renate Schulze-Rath - Chief Investigator - Bayer AG
Renate Schulze-Rath - Corresponding Applicant - Bayer AG
Charles Kreilick - Collaborator - Bayer AG
Kamonthip Wichmann - Collaborator - Bayer AG
Lucia Soriano - Collaborator - University Complutense of Madrid
Luis Alberto Garcia Rodriguez - Collaborator - CEIFEOutcomes:
To describe utilization patterns of ulipristal, including switching to other medications and the invasive gynecological treatments following treatment with ulipristal
- To provide detailed information on baseline demographic and clinical characteristics of women newly exposed to ulipristal, including its indication (uterine fibroids, endometriosis, heavy menstrual bleeding, other)
- To describe gynaecological diagnostic procedures, pharmacological treatments and healthcare resource use (primary, secondary, hospitalizations) within 1 year and invasive gynaecological treatments within the 5 years prior to receiving the first prescription of ulipristal
- To describe occurrence of pregnancy events in women newly exposed to ulipristal from the start of ulipristal use to the study endDescription: Technical Summary
Background
Bayer is developing a new selective progesterone receptor modulator (SPRM), Vilaprisan, for long-term pharmacological UF treatment. To prepare access and health-economic evidence, a detailed description of the ulipristal target population and treatment pathways in a large and well-characterized sample of women are needed.Objectives
This population-based descriptive study will characterize first-time users of ulipristal and utilisation patterns including switching to other medications and invasive gynaecological treatments following ulipristal treatmentMethods
This is a retrospective cohort study with prospective data collection, designed to assess the characteristics of women and patterns of drug utilization in new users of ulipristal in the UK. Data will be obtained by merging the The Health Improvement Network (THIN) and the Clinical Practice Research Datalink (CPRD), with the latter supplemented by data from HES database. The enrolment period will be from January 1, 2012 (year ulipristal became available in the UK) to April 30, 2017 (THIN) and the latest available version of CPRD. All women with at least one prescription of ulipristal during the study period will be included.
Data analysis
The study is of descriptive nature. The analyses will be conducted using standard summary statistics such as means and proportions; continuous data will be presented as means with standard deviation (SD) and as medians with inter quartile range (IQR, min and max) when appropriate; categorical variables will be presented as counts (n) and proportions (%). Missing data will not be imputed. Survival analyses will be used for time-to-event outcomes (e.g. time to invasive gynaecological treatments after the last ulipristal course, time to pregnancy, etc.); women will be censored at the date of last practice data collection. The analyses will be performed for the total and sub-cohorts with respective number of ulipristal courses (i.e. women with 1, 2, 3, and 4 courses during the study period). The alternative sub-cohort's cuts may be considered after a review of ulipristal treatment pattern.
The details on reporting and analysis of individual outcomes (incl. subgroups, handling of competing risk/events in survival analysis) will be described in the statistical analysis plan (SAP).
Statistical analyses will be performed using STATA package version 12.0 (StataCorp LP, College Station, TX, USA).
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A retrospective observational study describing the health impact of SABA over-prescription and ICS under-prescription among asthma patients — Ekaterina Maslova ...
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A retrospective observational study describing the health impact of SABA over-prescription and ICS under-prescription among asthma patients
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-17
Organisations:
Ekaterina Maslova - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Ekaterina Maslova - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
- Collaborator -
Claudia Cabrera - Collaborator - Astra Zeneca R&D Molndal Sweden
Divyansh Srivastava - Collaborator - ZS Associates
Eleni Rapsomaniki - Collaborator - Astra Zeneca Ltd - UK Headquarters
Jennifer Quint - Collaborator - Imperial College London
Jil Billy Mamza - Collaborator - Astra Zeneca Ltd - UK Headquarters
Keith Peres da Costa - Collaborator - ZS Associates
Vasanth Radhakrishnan - Collaborator - ZS AssociatesOutcomes:
Asthma exacerbations
- Asthma control
- Asthma-related health resource use
- Asthma medication use
- All-cause Mortality
- Asthmas-specific mortalityDescription: Technical Summary
We will describe the UKÂs current asthma population in terms of its SABA and ICS prescriptions, and temporal patterns (dataset=all eligible current asthma patients in CPRD). Patients will be categorised according to their SABA and ICS use in terms of British asthma guidelines. We will describe the demographic characteristics, asthma-related characteristics, treatment patterns, and exacerbations by BTS/GINA step and prescription coverage of ICS prescriptions. We will use a cohort study design to compare the effects of different patterns of SABA prescriptions on health outcomes (main outcome=exacerbations; using Cox and negative binomial models), healthcare resource utilisation (main outcome=GP visits; using Poisson or negative binomial models, depending on distribution) (dataset=all eligible current asthma patients in CPRD that are linked with HES-ONS, for exacerbations, or not linked for healthcare resource), and cost (financial and environmental; using negative binomial model in HES-linked data). SABA prescriptions will be the main exposure, derived from 12 months of prescription data before the study start, both as categorical and continuous. Models will be adjusted for multiple potential confounders, including ICS prescriptions. If the descriptive analysis shows patients change between exposure categories over time then this will be taken into account by censoring patients when they change exposure category, and in sensitivity analyses, by taking into account the time-varying exposures.
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Individual-level cost-of-illness Analysis for FoResight and Modelling for European HEalth Policy and Regulation (FRESHER) Project using linked English Data — Franco Sassi ...
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Individual-level cost-of-illness Analysis for FoResight and Modelling for European HEalth Policy and Regulation (FRESHER) Project using linked English Data
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-02
Organisations:
Franco Sassi - Chief Investigator - Imperial College London
Franco Sassi - Corresponding Applicant - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Sophie Thiebaut - Collaborator - Imperial College LondonOutcomes:
Primary: Quantify differences in healthcare utilisation for people with 10 specific non-communicable diseases (NCDs) - stroke, heart disease, cancer, diabetes, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), cirrhosis, alcohol use disorder (AUD), depression and neurologic disorders - relative to persons without these NCDs over the period of one year between 01/01/2015 and 01/01/2016.
- Secondary: Compute the additional cost of any excess healthcare utilisation over this period.Description: Technical Summary
This work aims to determine the cost-of-illness (COI) - the excess cost of healthcare utilisation - for 10 Non-Communicable Diseases (NCD's): Stroke, Heart disease, Cancer, Diabetes, Chronic kidney disease (CKD), Chronic obstructive pulmonary disease (COPD), Cirrhosis, Alcohol use disorder (AUD), Depression, and Neurological disorders (Alzheimer's and dementia).
The study population will be all acceptable patients in the November 2017 denominator file who are 18 and over in 2015 with a current registration date before study start and any length enrolment during the study period of 01/01/2015 - 31/12/2015 for practices with a UTS and LCD pre-post 2015. We will identify individuals with NCD's of interest, and compute the average healthcare costs associated with the healthcare utilisation of individuals with each specific NCD for any length within the study period using reference costs from the NHS. We will compare the average healthcare utilisation of patients with NCD's, stratified by age and sex, to those without NCD's.
This work replicates the methodology used to estimate NCD COI in France, Estonia and The Netherlands as part of the FRESHER project. Results from England will be used along with results from other countries to inform the FRESHER microsimulation model used to compare NCD costs across European countries.
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Unmet Needs, Symptom Burden, and Health Care Utilisation of Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Respiratory Maintenance Therapy in the United Kingdom (UK) — Leah Sansbury ...
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Unmet Needs, Symptom Burden, and Health Care Utilisation of Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Respiratory Maintenance Therapy in the United Kingdom (UK)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-24
Organisations:
Leah Sansbury - Chief Investigator - GlaxoSmithKline - UK
Leah Sansbury - Corresponding Applicant - GlaxoSmithKline - UK
Chanchal Bains - Collaborator - GlaxoSmithKline - UK
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.Outcomes:
Patient demographics
- Respiratory history and disease severity
- Respiratory medications
- Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations)Description: Technical Summary
Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of disorders including chronic bronchitis and emphysema that is characterised by airflow obstruction, that is both progressive and largely irreversible. Global initiative for chronic Obstructive Lung Disease (GOLD) strategy document proposes suitable first and secondary choice pharmacologic therapies depending on disease severity (GOLD 2017). Despite these evidence-based guidelines, observational studies have shown that routine practice of prescribing treatment for COPD is not always aligned with these recommendations. In addition, some patients who continue to have worsening of symptoms and exacerbations are not offered a step-up or change in long-acting bronchodilator (LABD) therapy. It is therefore important to understand whether there are patient and disease factors that contribute to the pattern of prescribing. In addition, in order to improve effectiveness of health-care delivery and improve patients' lives, it is vital to understand which patients are reporting poor disease control, their characteristics and outcomes. The current study aims to characterise COPD patients who initiate therapy with LABD maintenance medication and how long they persist with the specific therapy. We will also describe COPD disease burden and health care utilization over 12 months of follow-up by these treatment groups.
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Weight change and the onset and progression of cardiovascular diseases in large scale electronic health records — Michail Katsoulis ...
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Weight change and the onset and progression of cardiovascular diseases in large scale electronic health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-04-05
Organisations:
Michail Katsoulis - Chief Investigator - Farr Institute of Health Informatics Research
Michail Katsoulis - Corresponding Applicant - Farr Institute of Health Informatics Research
Aasiyah Rashan - Collaborator - University College London ( UCL )
Amitava Banerjee - Collaborator - University College London ( UCL )
Asma Alfayez - Collaborator - University College London ( UCL )
Burcu Ozaltin - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Manuel Gomes - Collaborator - University College London ( UCL )
Miguel Hernan - Collaborator - Harvard University
Spiros Denaxas - Collaborator - University College London ( UCL )
Tianyi Liu - Collaborator - University College London ( UCL )Outcomes:
myocardial infarction
- heart failure
- ischaemic/ haemorrhage/ unclassified stroke
- stable/unstable angina
- atrial fibrillation
- Subarachnoid haemorrhage
- unheralded coronary death
- sudden cardiac death
- peripheral artery disease
- coronary revascularization
- Abdominal aortic aneurysm
- coronary revascularization
- composite CVD outcome - containing all CVDs
- hypertrophic cardiomyopathy
- composite CVD outcome - containing all CVDs
- Overall mortality
- CVD mortality - Composite CVD outcomeDescription: Technical Summary
Weight change trajectories over time and the subsequent effects on cardiovascular diseases (CVDs) have not been investigated in large scale populations with contemporary levels of obesity. This study aims to fill this gap through evaluation of linked Electronic Health Records [Clinical Practice Research Datalink (CPRD), Hospital Episode Statistics (HES) and Office for National Statistics (ONS). Firstly, we will calculate the short-, mid- and long-term patterns of weight fluctuation at different population groups. Moreover, we will use marginal structural Cox models, based on the inverse probability of weighting to tackle time-dependent confounding and estimate the impact of different weight change patterns (combined with other CVD factors) with the initial onset and progression of CVD overall, as well as of different and pathologically-diverse CVDs, for which randomized controlled trials are not viable. More specifically, using the inverse probability weights, we create a pseudo-population where treatment and control patients have the same probability of being assigned to treatment, at each time point, conditional on observed data. Finally, risk prediction scores for CVDs, like for Framingham risk score and QRISK will be evaluated and subsequently updated, by including weight change into them, to check to what extend their predictive ability is improved.
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2018 - 03
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Cholesterol lowering medications and risk of fatty liver disease and liver cancer — Katherine McGlynn ...
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Cholesterol lowering medications and risk of fatty liver disease and liver cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Katherine McGlynn - Chief Investigator - National Institutes of Health - USA
Katherine McGlynn - Corresponding Applicant - National Institutes of Health - USA
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Jake Thistle - Collaborator - National Cancer Institute ( NCI )
Jessica Petrick - Collaborator - National Cancer Institute ( NCI )Outcomes:
Liver Cancer; Fatty Liver Disease.
Description: Technical Summary
In a previous CPRD study, our group found that use of statins (HMG-CoA reductase inhibitors) was associated with a significantly reduced risk of primary liver cancer. Whether statins are also associated with a reduced risk of developing a precursor of liver cancer, fatty liver disease, has not been well studied. Also not well studied is whether other cholesterol lowering drugs (bile acid resins, cholesterol absorption inhibitors, fibrates, niacin, and omega 3 fatty acids) are associated with a lower risk of fatty liver disease or liver cancer. Therefore, the proposed study will examine the effect of all classes of cholesterol lowering medications on risk of fatty liver disease and liver cancer. We propose to conduct a case-control study which will match controls to cases at a 4:1 ratio. Matching factors include age, sex, general practice and length of time in CPRD. We will examine ever/never use as well as duration of use, cumulative dose (summation of doses in each prescription), and length of use. We will use conditional logistic regression to assess crude and adjusted risk estimates (odds ratios and 95% confidence intervals).
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Rheumatological conditions as risk factors for self-harm. A retrospective cohort study — James Prior ...
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Rheumatological conditions as risk factors for self-harm. A retrospective cohort study
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
James Prior - Chief Investigator - Keele University
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Athula Sumathipala - Collaborator - Keele University
Carolyn Chew-Graham - Collaborator - Keele University
Christian Mallen - Collaborator - Keele University
Rebecca Whittle - Collaborator - Keele University
Tom Shepherd - Collaborator - Keele University
Zoe Paskins - Collaborator - Keele UniversityOutcomes:
Aim 1: Cases with a rheumatological condition will be examined for subsequent self-harm codes. Self-harm will be based on the National Institute for Health and Clinical Excellence (NICE) guidelines (CG16) definition of self-harm and Read code list used in previous research (2) (Appendix 1). Specific characteristics within these rheumatological conditions will be reported (deprivation, anxiety, depression etc) and adjusted for when comparing to controls without a self-harm code.
Aim 2: In the cohort of those with a rheumatological condition and self-harm, we will determine the role of several different patient characteristics on the risk of self-harming. These will include age, gender, level of deprivation and geographical area.Description: Technical Summary
Every year in UK primary care, there are 12.3 and 17.9 incident cases of self-harm per 10,000 male and female patients respectively. As such, primary care presents an opportunity to address self-harm and intervene in potential cases, with one recommended approach being to target groups who are at high-risk of self-harming. Patients with rheumatological conditions (Musculoskeletal rheumatological: osteoarthritis (OA), osteoporosis (OP) or fibromyalgia or Inflammatory rheumatological: rheumatoid arthritis (RA) or ankylosing spondylitis (AS)), who are often managed in primary care, are exposed to several known risk factors for self-harm (such as chronic pain, depression, anxiety) and are therefore potential at-risk groups.
Our research will examine whether patients with rheumatological conditions are more likely to self-harm than other comparable groups of patients. We will undertake a matched retrospective cohort study using data from the CPRD. Our primary outcomes of interest will be the prevalence and incidence of self-harm Read codes (CPRD). Cox proportional hazards models will be used to compare risk of self-harm in patients with rheumatological conditions compared to controls. Understanding the role each rheumatological condition has on self-harm could highlight vulnerable patients for clinicians to focus on or where new interventions may be necessary.
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Distal Renal Tubular Acidosis and Cystinuria in Adult and Paediatric populations: epidemiology, patient pathways and costs in the U.K — Monique Martin ...
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Distal Renal Tubular Acidosis and Cystinuria in Adult and Paediatric populations: epidemiology, patient pathways and costs in the U.K
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Monique Martin - Chief Investigator - Not from an Organisation
Lucile Marie - Corresponding Applicant - Syneos Health ( inVentiv Health Clinical )
Florence Bianic - Collaborator - Syneos Health ( inVentiv Health Clinical )Outcomes:
The first outcomes of interest will be GP diagnosis of dRTA and cystinuria.
Then, various diagnosis codes will be studied as well as drug utilisation and referrals to specialist to identify additional patients possibly suffering from these two conditions but without a formal diagnosis. The codes related to associated syndromes or diseases with similar symptoms. The list of codes has been reviewed by a clinical expert in dRTA and cystinuria.
The identification of the additional patients will be further validated by clinical expert opinion.
Once these patients have been identified, age and gender will be the variables of interest to estimate the global prevalence.
In a second step of our study, the resource use (hospitalisations, laboratory tests, specialist's referrals...) will be the outcomes of interest.Description: Technical Summary
The objectives of the study are (1) to estimate the prevalence of children and adults suffering from dRTA or cystinuria; (2) to study patient pathways; (3) and to evaluate the financial burden of medical care of these two conditions.
Using the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases, we will study the patients with a coded general practitioner (GP) diagnosis of dRTA and those with a coded diagnosis of cystinuria. Genetic dRTA and cystinuria are well diagnosed but acquired dRTA may be misdiagnosed since patients are suffering from various associated syndromes and/or several conditions with similar symptoms. These patients need to be studied in terms of treatment and pathways to be sure of the accuracy of the estimates.
The main analyses will consist of descriptive analyses to evaluate the prevalence of the two conditions in adult and children populations. Resource use for both inpatient (number of stays and length of stay, etc.) and outpatient (prescription items, referrals visits, etc.) will be estimated for these patients.
Finally, these estimates will be scaled up to the entire population and will be used to evaluate the financial burden of medical care of dRTA and cystinuria in the UK.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 2 - Replication of "Drug therapy for alcohol dependence in primary care in the UK: A Clinical Practice Research Datalink study" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 2 - Replication of "Drug therapy for alcohol dependence in primary care in the UK: A Clinical Practice Research Datalink study"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-25
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Prescription of acamprosate, disulfiram, naltrexone, baclofen and topiramate.
Description: Technical Summary
This objective of this protocol is to replicate the study: 'Drug Therapy for alcohol dependence in primary care in the UK: A Clinical Practice Research Datalink study' by Thompson et al. based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to ascertain which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Thompson paper describes use of drug therapy for alcohol dependence within 12 months after first diagnosis in UK primary care between1990-2013. We will focus on replicating this outcome. Drug therapy for alcohol dependence was defined as prescription of acamprosate, disulfiram, naltrexone, baclofen and topiramate. Follow up was censored at the first of: 12 months following incident alcohol dependence diagnosis, the date of transfer of the patient out of the practice, the patient's death as recorded in the CPRD database, or end of study period.
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Evaluating and enhancing the primary care medicines review in patients with complex health needs — Emma Baker ...
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Evaluating and enhancing the primary care medicines review in patients with complex health needs
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-09
Organisations:
Emma Baker - Chief Investigator - St George's, University of London
Iain Carey - Corresponding Applicant - St George's, University of London
Chris Threapleton - Collaborator - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Fay Hosking - Collaborator - St George's, University of London
Henry Fok - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - St George's, University of LondonOutcomes:
The health outcomes in our study will primarily come from the linked dataset. Our primary outcome will be emergency hospital admissions. We will also explore the sub-group of emergency admissions for Ambulatory Care Sensitive Conditions (ACSC), which are thought to be potentially preventable with better clinical management. Other outcomes we will explore are: all-cause mortality and number of primary care consultations.
Description: Technical Summary
Patients taking multiple medicines are at increased risk of adverse reactions, hospital admission and medication errors, and commonly do not adhere to treatment. National guidelines recommend that medicines should be optimised by annual review.
Our primary aim is to use CPRD to describe current practice relating to medicines reviews in patients at high risk of medicines-related harm (adults aged >50 years taking >10 concomitant medicines). We will describe the prevalence and frequency of medicines reviews, place and practitioner, factors predicting who gets a review, and resulting changes (e.g. stopping inappropriate medicines). We will investigate relationships between presence of review and subsequent hospital admission or death.
Clinical pharmacologists are doctors with particular expertise in use of medicines. Our secondary aim is to develop an enhanced clinical pharmacology assessment to improve medicines reviews in patients with complex health needs, taking into account relationships between multiple medicines and diseases. Potential benefits will be determined in 200 randomly selected patients from the initial cohort by comparing medication changes recommended by the enhanced review to those resulting from the standard review. Results will provide a basis for further exploration of the role of clinical pharmacologists in decision-making for patients with complex co-morbidity and polypharmacy.
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Risks of glucocorticoid therapy in PMR and GCA patients with co-existing type 2 diabetes — Toby Helliwell ...
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Risks of glucocorticoid therapy in PMR and GCA patients with co-existing type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-25
Organisations:
Toby Helliwell - Chief Investigator - Keele University
Toby Helliwell - Corresponding Applicant - Keele University
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Christian Mallen - Collaborator - Keele University
Milica Bucknall - Collaborator - Keele University
Sara Muller - Collaborator - Keele UniversityOutcomes:
Change in HbA1C of 5 mmol/l (NICE, America Diabetes Association)Change in HbA1C of 5 mmol/l (NICE, America Diabetes Association)
Type 2 diabetes related complications: retinopathy, neuropathy, cerebrovascular accident, cardiovascular disease, cataracts, deathDescription: Technical Summary
Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic illness affecting patients over 50 years old, causing severe muscle pain with joint pain and stiffness and impacts on work, daily life and activity. The life-time risk is 2.4% in women and 1.7% in men and is linked to giant cell arteritis (GCA), which if not treated appropriately can cause irreversible blindness. Both are treated with glucocorticoid medications which have the potential to cause adverse effects (e.g. osteoporosis) and exacerbate co-existing illnesses (e.g. diabetes). Current guidance suggests that glucocorticoid sparing agents be considered if a significant risk of developing adverse effects exists. However, exactly who should receive these alternatives is not specified. This study will investigate the impact of glucocorticoid treatment in incident PMR and GCA patients with co-existing diabetes (a common comorbidity in patients over 50 years old and potentially affected by glucocorticoid treatment). The Clinical Practice Research Datalink (CPRD) will be used to identify PMR/GCA patients with diabetes to quantify the impact of glucocorticoid treatment after being diagnosed and treated. This will clarify if the impact of glucocorticoid treatment on diabetes is significant and whether these patients should be considered high risk and appropriate for glucocorticoid sparing therapy.
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Evaluating and Discovering Indicators of Care from Observational Data: A Case Study on Atrial Fibrillation — William Tong ...
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Evaluating and Discovering Indicators of Care from Observational Data: A Case Study on Atrial Fibrillation
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-14
Organisations:
William Tong - Chief Investigator - Macquarie University
William Tong - Corresponding Applicant - Macquarie University
Blanca Gallego Luxan - Collaborator - Macquarie University
Enrico Coiera - Collaborator - Macquarie University
Thierry Wendling - Collaborator - Not from an Organisation
William Runciman - Collaborator - University Of South AustraliaOutcomes:
All-cause mortality
- Ischaemic stroke and systemic embolism
- Major bleedingDescription: Technical Summary
We will conduct a 2-phase case study on indicators of care in non-valvular atrial fibrillation, the most common sustained cardiac arrhythmia.
In phase 1 we evaluate existing consensus-based indicators of care as described in the literature [1, 2]. Patients will be divided into a control group, for which the indicated care under consideration has not been applied, and an intervention group. The average treatment effect of the indicated care on selected outcomes will be estimated using inverse probability of treatment weighting. To validate the method, we aim to show agreement with our data-driven approach to evidence-based indicators of care in the literature.
In phase 2, a tool that can screen for new potential indicators and re-evaluate the benefit of existing indicators will be developed using regularised survival analysis. We stratify patients into risk groups using Charlson Comorbidity Index, CHA2DS2-VASc and HAS-BLED scores, and screen for clinical indicators of care associated with good patient outcomes within each patient group using the regularisation process. The indicators of care correspond to drug therapies, devices, procedures and pathology tests. The Cox proportional hazard model with regularisation will be used to model the time-to-event outcomes with time-varying covariates covering both patient characteristics and interventions.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 8 - Replication of "Incidence of type 2 diabetes after bariatric surgery" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 8 - Replication of "Incidence of type 2 diabetes after bariatric surgery"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-27
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Development of clinical diabetes.
Description: Technical Summary
This objective of this protocol is to replicate the study: "Incidence of type 2 diabetes after bariatric surgery: population-based matched cohort study" by Booth et al. based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to ascertain which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Booth paper compares the development of clinical diabetes in patients who had bariatric surgery before April 30th, 2014 to those who did not have surgery. We will focus on replicating the outcome of development of clinical diabetes over this time period. To assess diabetes onset, a time-to-event framework is used, using a Cox proportional hazards model.
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Beta 2 agonists and the incidence of Parkinson's disease — Samy Suissa ...
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Beta 2 agonists and the incidence of Parkinson's disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-25
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Francesco Giorgianni - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Parkinson's disease.
Description: Technical Summary
A recent study hypothesized that salbutamol, a beta2-adrenoceptor (beta2AR) agonist, might have a protective effect in the development of PD. To test this hypothesis, we will assemble a cohort of all individuals in the CPRD aged 50 or over between 1995 and 2016. We will exclude patients with PD or patients who were prescribed antiparkinsonian drugs before cohort entry and patients previously exposed to beta2AR agonists or beta antagonists before cohort entry. Within this cohort, all incident cases of PD will be matched to ten controls per case on age, sex, general practice, calendar year of cohort entry, and duration of follow-up. Conditional logistic regression will be used to estimate odds ratios with 95% confidence intervals of PD associated with the ever use, cumulative duration of use, and cumulative dose of beta2AR agonists compared with no use. In all models, exposure to beta2AR agonists will be lagged by one year to take into account a biologically plausible latency time window. The same analyses will be repeated for exposure to beta-blockers. In addition to the matching variables, all models will be adjusted for potential confounders. We will perform several sensitivity analyses to test the robustness of our findings.
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COMIX Â Comorbidity index for predicting mortality in clinical studies as well as comparing its performance to existing comorbidity indices. — Ruth Farmer ...
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COMIX Â Comorbidity index for predicting mortality in clinical studies as well as comparing its performance to existing comorbidity indices.
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-01
Organisations:
Ruth Farmer - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Urvee Karsanji - Corresponding Applicant - University of Leicester
Alicia Gayle - Collaborator - Imperial College London
Michael Marcus - Collaborator - University of Liverpool
Naj Rotheram - Collaborator - Boehringer-Ingelheim - UK
Urvee Karsanji - Collaborator - University of LeicesterOutcomes: none known
Description: Technical Summary
This study is a retrospective cohort study using patient data from the CPRD to gain insights on devising an alternative method to classify comorbid conditions and predict one years mortality, for patients with one or more comorbid conditions, for Read coded databases. The main objective is to develop a prognostic classification for comorbid conditions which individually or in combination might alter the risk of short term mortality for patients enrolled in clinical research. All individual diseases identified in the Charlson index will be applied to our patient cohort and then this list will be condensed down into the main comorbid conditions displayed in our population. A model will be run to determine whether the existing Charlson weighting for comorbid diseases is still valid or whether the severity of these diseases has changed over time. The potential effect that this may have on predicting mortality rate is yet to be studied. Descriptive statistics, univariate and multivariate analyses, CoxÂs proportional hazard model, will be used to perform data analysis associated with predicting mortality, The results from this study will be used to support scientific understanding of how this updated assessment of disease severity and predicting mortality may influence others.
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Statin use in chronic obstructive pulmonary disease (COPD) patients and risk of exacerbations: a propensity score matched cohort study — Margaret Smith ...
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Statin use in chronic obstructive pulmonary disease (COPD) patients and risk of exacerbations: a propensity score matched cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-08
Organisations:
Margaret Smith - Chief Investigator - University of Oxford
Margaret Smith - Corresponding Applicant - University of Oxford
Christopher Butler - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Helen Ashdown - Collaborator - University of Oxford
James Sheppard - Collaborator - University of OxfordOutcomes:
Primary outcome: Time to first exacerbation and exacerbation rate.
- Primary outcome: Severe exacerbation requiring hospitalisation
- Secondary outcome: all-cause mortality
- Secondary outcome: Urinary tract infection (negative control)Description: Technical Summary
Statins are widely used for prevention of cardiovascular disease (CVD), a significant comorbidity in COPD. There is increasing evidence that COPD is a systemic inflammatory disease and that statins have anti-inflammatory properties. Therefore, statins might reduce the severity/frequency of COPD exacerbations. Several observational studies have found statin use to be associated with lower exacerbation rates. However, a trial of simvastatin for preventing exacerbations was stopped early due to lack of benefit. It has been hypothesised that this was due to restriction of the trial population to people without CVD who would have lower levels of inflammation and therefore be least likely to benefit. Furthermore, the observational studies may have been subject to biases e.g. immortal-time or prevalent-user bias.
Given the high burden of exacerbations to the NHS and to individuals, and that statins are inexpensive and widely accepted, the possibility of statins having a direct role in COPD management should be investigated further. We will design a historical cohort study using the CPRD. Our population will include different severities of COPD. We will use a new-user design with propensity score matching to minimise bias. Our results would be used to justify (or not) and design another trial, including selection of subgroups most likely to benefit.
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Exploring ethnicity as a risk factor for post-stroke dementia: a cohort study using the UK Clinical Practice Research Datalink — Harriet Forbes ...
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Exploring ethnicity as a risk factor for post-stroke dementia: a cohort study using the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-20
Organisations:
Harriet Forbes - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Gharti Magar - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Neil Pearce - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Outcomes will be incident dementia, categorised into early post-stroke dementia (from three months to one year post stroke)[8] and later post-stroke dementia (from one to five years post stroke). The first three months post stroke will be excluded due to the risk of misclassification of reversible cognitive changes associated with stroke as dementia.
Although it is likely that post-stroke dementia will have a primarily vascular origin, dementia often has a mixed pathology and specific diagnosis is infrequently recorded. We will therefore use a broad definition that incorporates codes for vascular dementia, AlzheimerÂs disease and unspecified dementia. These are:ICD-10 codes
F00* Dementia in Alzheimer disease
F01 Vascular dementia
F03 Unspecified dementiaWe will also obtain a list of codes classified under ÂF02* Dementia in diseases classified elsewhereÂ, which refer to dementia associated with known conditions such as Pick disease, CJD, HuntingtonÂs disease, ParkinsonÂs disease, HIV and other chronic conditions. In sensitivity analysis we will investigate the effect of including dementia cases based on these codes. We will use the mapping tool available at http://dementiapartnerships.com/resource/dementia-read-codes/ to map these groups of ICD-10 codes to Read codes. This list will be reconciled with previous codelists used in a CPRD study of dementia as well as published dementia Read codelists from previous studies e.g. https://clinicalcodes.rss.mhs.man.ac.uk/medcodes/article/25/codelist/re⦠then reviewed clinically by Professor Smeeth. The provisional code lists used to generate feasibility counts is shown in appendix 2.
Description: Technical Summary
Cognitive problems contribute substantially to the disability experienced after stroke and result in a major health and societal burden. Both short- and long-term cognitive changes occur after stroke, but reasons for the development of post-stroke dementia remain unclear. Despite evidence suggesting ethnicity is a risk factor for dementia, the role of ethnicity in post-stroke dementia has been poorly described globally, and to our knowledge, the incidence of post-stroke dementia by ethnicity has not been described in a UK setting.
Here we aim to investigate the association between ethnicity and incident dementia in a population cohort of adult stroke survivors using electronic health records (EHR). Using routinely collected EHR data will increase power and generalisability of findings as well as overcoming some methodological difficulties that may hamper traditional cohort studies of post-stroke dementia such as ascertainment bias. We will carry out a multivariable Cox regression analysis to compare incidence rates of post-stroke dementia among White and non-White ethnic groups in time periods after stroke, controlling for potential socio-demographic and clinical confounding factors. In secondary analyses, we will use a categorical exposure variable for ethnicity, subdividing non-White individuals into Black, Asian and Mixed.
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Migraine in the UK: A descriptive cohort study of the burden of disease and health care resource utilisation — Rebecca Ghosh ...
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Migraine in the UK: A descriptive cohort study of the burden of disease and health care resource utilisation
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-19
Organisations:
Rebecca Ghosh - Chief Investigator - CPRD
Rebecca Ghosh - Corresponding Applicant - CPRD
Alison Williams - Collaborator - Novartis UK
Dee Stoneman - Collaborator - Novartis UK
Eleanor Yelland - Collaborator - CPRD
Kara Gibson - Collaborator - Novartis UK
Rachael Williams - Collaborator - CPRD
Sandra Lopez Leon - Collaborator - Novartis Farmaceutica S.A.
Tarita Murray-Thomas - Collaborator - CPRD
Victoria Hacking - Collaborator - Novartis UKOutcomes:
Incident diagnosis of migraine or headache
Prophylactic migraine treatment, patterns and pathways
Health care utilisation
o GP consultations
o Referrals to secondary care
o Secondary care attendance (Inpatient, outpatient, A&E)
Chronic and episodic migraine
Acute migraine treatmentDescription: Technical Summary
Migraine is a common neurological disorder that affects a large proportion of the population. It causes substantial impairment and disability and is associated with significant financial costs to the National Health Service. This cohort study will characterise the migraine population in the United Kingdom, describe drug treatment patterns and pathways, including medication adherence, and quantify health care resource use and direct costs. Data from primary care and hospital (admissions, outpatient, and accident and emergency visits) will be used in this study.
Patients ?18 years of age with an incident diagnosis of migraine will be included. Demographic characteristics, comorbidities, treatment patterns, resource use and costs will be estimated and stratified by acute and prophylactic treatment groups. Treatment adherence will be descried as continuous use, augmentation, switching or discontinuation. Resource use and costs will be estimated for an indicative year (2016/17). As secondary objectives we will also explore the feasibility of distinguishing between chronic and episodic migraine and will assess the agreement and completeness of recording secondary care contact in primary care.
Descriptive statistics (numbers, proportions, averages and ranges) will be presented and rates of health resource use and direct costs will be presented as total and mean per person per year.
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Predictive value of cancer for dementia in cohorts with and without T2DM: a national observational study — Michael Soljak ...
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Predictive value of cancer for dementia in cohorts with and without T2DM: a national observational study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Darina Bassil - Corresponding Applicant - Harvard School of Public Health ( HSPH )
Ailsa McKay - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
David Muller - Collaborator - Imperial College London
Ioanna Tzoulaki - Collaborator - Imperial College London
Lefkos Middleton - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes:
1. Any dementia: record of CPRD medcode or prodcode, HES ICD10 code or ONS ICD9/10 code indicative of any dementia diagnosis (see list in Annex 2). Through other ISAC approved dementia research projects e.g. 16_143, we will also be developing and testing a dementia diagnosis algorithm using codes other than CPRD or HES diagnoses. 2. Dementia likely attributable to Alzheimerâs disease: record of CPRD medcode ,HES ICD10 code or ONS ICD9/10 code indicative of a diagnosis of Alzheimerâs disease (see list in Annex 10).The most recent and currently adopted 2011 NIA-AA Criteria for Alzheimerâs Disease will be used for a more accurate diagnosis: Dementia possibly attributable to Alzheimerâs disease (medcodes indicating a diagnosis for Alzheimerâs disease but with the evidence of another record of a medcode indicating another type of late onset dementia ) and dementia probably attributable to Alzheimerâs disease ( medcodes indicating a diagnosis for Alzheimerâs diseases without a later record of a medcode indicative of another type of late onset dementia).
Description: Technical Summary
This study will be a retrospective open cohort study. The overall aim is to examine the relationship between cancer and late onset dementia separately in a T2DM and non-T2DM cohort, using routine English primary care data. Our outcome of interest will include participants with a diagnosis of dementia as well as those with a diagnosis of dementia attributable to Alzheimerâs disease. We will first aim to estimate the incidence rates of cancer and dementia separately in subpopulations with and without T2DM. We will then estimate the incidence rates of diagnosed dementia among those with and without cancer. Cox proportional hazard models, with time-dependent covariates, will be used to determine the risk of overall dementia and dementia likely attributable to Alzheimerâs disease in those with and without a cancer diagnosis. The hazard ratios (HRs) will be adjusted to account for various possible confounders identified in the literature. We will use propensity score analysis to correct for confounding. Additionally, Fine and Gray competing risk models with sub-distribution Hazard Ratios (sdHRs) for overall dementia and dementia attributable to Alzheimerâs disease will be used; along with cumulative incidence risk plots of dementia, to account for death as a competing risk in our study.
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The progression of ischaemic heart disease to heart failure in different ethnic groups; a contemporary population-based cohort study in England — Claire Lawson ...
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The progression of ischaemic heart disease to heart failure in different ethnic groups; a contemporary population-based cohort study in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-19
Organisations:
Claire Lawson - Chief Investigator - University of Leicester
Claire Lawson - Corresponding Applicant - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Gabriele Messina - Collaborator - Sienna University
Gerry McCann - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Laura Gray - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Umesh T Kadam - Collaborator - Keele UniversityOutcomes:
Incident heart failure
HF incidence will be identified using a combination of Read and ICD-10 codes in the CPRD, HES and Office of National Statistics (ONS) data files. The CPRD HF code set has been used previously (protocol 12_162A) and was based on Read code CG58 and daughter codes. Additional codes were added following a structured search using the CPRD medical code dictionary browser for the clinical terms ÂventricularÂ, Âcardiac or Âheart in combination with ÂfailureÂ. All but one process code (ÂHF confirmedÂ) was eliminated from this latter search as they represented ongoing care or symptoms in a prevalent cohort rather than the index date of HF. The code set was validated by HF specialists and against previous literature32,33 (see appendix 1). The ICD-10 HF code set will be based on I50 and its sub codes (see appendix 1). Date of HF incidence will be defined by the first event in any of the files. In the HES and ONS files, an ICD-10 code for HF in any position will be used. HF incidence indicated at death will be identified by the ONS linked data file. The date of HF incidence for these subjects will be defined by the death date. Given that there are a number of different entry types within the CPRD that indicate a death event and each has an associated date, there may be multiple records and dates for any one patient. The study HF incidence date (date of death) will be derived using a CPRD verified algorithm which takes the earliest of the patient transfer out date (with reason ÂdeathÂ), first statement of death Read code or date of death/record added in the death administration area of the CPRD. Where death dates occur in all 3 linked records the earliest will be used.
Competing outcome
Death by any cause other than HF will be a competing event for the development of HF. This will be defined as death by any cause recorded in the patients CPRD or linked HES or ONS records that was not identified as a ÂHF incidence event in the linked ONS record that supplies cause of death. Again, the study date of competing event (non-HF death) will be derived using a CPRD verified algorithm which takes the earliest of the patient transfer out date (with reason ÂdeathÂ), first statement of death Read code or date of death/record added in the death administration area of the CPRD. Where death dates occur in all 3 linked records the earliest will be used.Description: Technical Summary
In four objectives, this study aims to quantify and characterise the progression of IHD to new HF onset in different ethnic groups. Small scale cross-sectional studies have shown that the prevalence of antecedent IHD in HF populations is common but differs significantly according to ethnicity status. Aetiological evidence on the progression of IHD to HF has underrepresented minority ethnic groups and been limited by baseline approaches that ignore the accrual of IHD and other risk factors over time. Objective 1 will investigate whether HF incidence rates have changed overtime in those with and without IHD and in different ethnic groups. Objective 2 will use Cox regression to investigate the association between IHD and HF incidence, the influence of ethnicity on this association and influence of other common comorbidities. The competing event of non-HF death will also be assessed. A marginal structural cox model will next be used to quantify the influence of IHD status and risk factors that change over time on HF incidence. Objective 3 will investigate whether independent predictors of HF incidence differ according to ethnicity status and Objective 4 will quantify the independent association between ethnicity and HF incidence using Cox regression models stratified by IHD status.
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A Comparison of the Effectiveness and Safety of Direct Oral Anticoagulants (DOACs) versus. Warfarin in Older People with Atrial Fibrillation — Anita McGrogan ...
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A Comparison of the Effectiveness and Safety of Direct Oral Anticoagulants (DOACs) versus. Warfarin in Older People with Atrial Fibrillation
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-27
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Anneka Mitchell - Corresponding Applicant - University of Bath
Julia Snowball - Collaborator - University of Bath
Margaret C Watson - Collaborator - University of Bath
Tomas Welsh - Collaborator - University of BristolOutcomes:
Ischaemic stroke; Composite of all bleeding; Major bleeding; Gastrointestinal bleeding; Clinically significant non-major bleeding; Myocardial infarction; All-cause mortality; Intracranial haemorrhage.
Description: Technical Summary
This study will describe the prescribing of oral anticoagulants to people over the age of 75 for the treatment of atrial fibrillation (AF) and investigate whether the newly introduced direct oral anticoagulants (DOACs) are as effective and safe as warfarin, which has been used for decades. Initially an explorative study will be conducted to review whether the characteristics of older people prescribed anticoagulants have changed since the introduction of DOACs. Cohort studies will then be used to investigate serious outcomes including ischaemic stroke, bleeding (major and clinically relevant), intracranial haemorrhage, gastrointestinal haemorrhage, myocardial infarction and mortality. Two comparator warfarin groups (one contemporary and one historical) will be used to evaluate the effect of channelling. People prescribed DOACs will be matched by age, sex, GP practice and index year to people prescribed warfarin during the same period or during a historical period before DOACs became available. Time to diagnosis of these outcomes will be compared using survival analysis. Covariates including smoking, alcohol, BMI, comorbidities and co-prescribing will be adjusted for. Renal impairment, body-weight, frailty, falls, co-morbidities, and polypharmacy may influence the safety of DOACs in older people with AF. This will be investigated using the regression model.
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Prescribing trends of gabapentinoids in UK primary care — Samy Suissa ...
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Prescribing trends of gabapentinoids in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-05
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Alvi Rahman - Collaborator - McGill University
Francois Montastruc - Collaborator - University Of Toulouse
Joseph Kane - Collaborator - Queen's University Belfast
Simone Loo - Collaborator - McGill UniversityOutcomes:
To estimate the yearly prescriptions rates of gabapentinoids (gabapentin and pregabalin, separately) in the UK primary care, between 1993 and 2017 in children, adolescents and adults;
To estimate the yearly rate of patients with a first gabapentinoid prescription (incident users) overall and stratified by indication (epilepsy, neuropathic pain/migraine, generalized anxiety disorder (only for pregabalin), non-neuropathic pain (off-label indication), and other off-label indications).Description: Technical Summary
The gabapentinoid drugs gabapentin and pregabalin are approved treatments for focal seizures and neuropathic pain, and were licensed in the UK in 1993 and 2004, respectively. Gabapentin is also licenced for the treatment of migraine in adults, while pregabalin is approved for the treatment of generalized anxiety disorder. Recent data in the UK and elsewhere indicate that gabapentinoid prescriptions are increasing, raising concerns about potential off label-use of these drugs. Moreover, the UK government has recently reclassified these drugs as class C controlled substances, after an increasing number of deaths were found to be related to their use. Given these safety concerns and the implications of the widespread use of these medications, we will conduct a drug utilization study using CPRD data between January 1, 1993 and December 31, 2017. We will estimate annual prescription rates and 95% confidence intervals for gabapentin and pregabalin separately, using Poisson regression. We will also estimate the rates of incident users over time, both overall and stratified by indications and off-label indications. Our results will provide insight as to how gabapentinoids have been prescribed in UK primary care practices since their licensing and approval.
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Survival of patients with heart failure in community (SurviveHF) — Clare Taylor ...
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Survival of patients with heart failure in community (SurviveHF)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-21
Organisations:
Clare Taylor - Chief Investigator - University of Oxford
Clare Taylor - Corresponding Applicant - University of Oxford
Andrea Roalfe - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Rafael Perera - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes:
Mortality
Cause of deathDescription: Technical Summary
Heart failure (HF) is a common and costly condition affecting 1-2% of adults. The aim of this study is to determine the survival rates of people with HF, and if prognosis has improved over time.
An open matched retrospective cohort study, using data from CPRD for the period between 1st January 2000 and 31st December 2017, will be conducted using records of people with and without a HF diagnosis. CPRD data will be linked to HES data to validate the code of HF and the Office for National Statistics death registration data to provide the date and cause of death.
Kaplan-Meier curves will be used to compare the survival in patients with and without HF and by age group, gender and deprivation quintile. One, 5 and 10-year survival rates for HF cases will be calculated for each 10-year age band. For comparison, survival rates of patients without a diagnosis of HF will also be determined. Cox proportional hazards regression analysis will be undertaken to assess the effect of HF on survival with adjustment for age, gender and practice. To examine trends over time, survival rates will be calculated by year of diagnosis.
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Risk factor trends and aetiological mechanisms leading to Heart Failure (HF) and outcomes; a study of ethnicity, gender and deprivation in the UK general population — Claire Lawson ...
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Risk factor trends and aetiological mechanisms leading to Heart Failure (HF) and outcomes; a study of ethnicity, gender and deprivation in the UK general population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-19
Organisations:
Claire Lawson - Chief Investigator - University of Leicester
Claire Lawson - Corresponding Applicant - University of Leicester
Francesco Zaccardi - Collaborator - University of Leicester
Iain Squire - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Laura Gray - Collaborator - University of Leicester
Melanie Davies - Collaborator - University of Leicester
Umesh T Kadam - Collaborator - Keele UniversityOutcomes:
All-cause admissions:
Hospital admissions will be identified through linkage of CPRD to HES data. Single hospital admissions will be defined by unique hospital spell numbers and date of admission will be used as the index admission date. For any admission with a discharge date at the end of the HES data year (31st March), subsequent admissions on the 1st April will be discounted. This is to allow for the artificial creation of two hospital spells by HES where one spell spans the end of HES data year.Cause-specific admissions:
Three categories of cause-specific admissions will be used including HF, other cardiovascular or non-cardiovascular admissions. Codes will be based on ICD-10 codes as follows: Heart failure (I50), other cardiovascular (chapter IX 'diseases of the circulatory system' excluding I50) and non-cardiovascular (other ICD-10 chapters excluding chapter 1X).Hospital bed days:
Hospital bed days will be the total number of nights in hospital calculated by the difference between admission and discharge dates.All-cause death:
The outcome will be all-cause mortality defined as death by any cause recorded in the patients CPRD or linked HES or ONS records. Given that there are a number of different entry types within the CPRD that indicate a death event and each has an associated date, there may be multiple records and dates for any one patient. The study date of death will be derived using a CPRD verified algorithm which takes the earliest of the patient transfer out date (with reason 'death'), first statement of death Read code or date of death/record added in the death administration area of the CPRD. Where death dates occur in all 3 linked records the earliest will be used.Cause-specific death:
In England and Wales, there is a legal requirement to register all deaths with the Office of National Statistics (ONS) which provides a complete data source for mortality statistics including cause of death coded using International Classification of Diseases (ICD) codes. However, assignment of a specific cause of death is subject to error, particularly when the patient has a number of underlying diseases or health factors. HF itself is considered a mediator between disease and death and is therefore ill-defined as a cause of death in favour of a more specific cause (such as myocardial infarction). HF is often applied where the aetiology is not known but this is not consistent and underreporting of circulatory diseases on death certificates is common. Conceptually, in considering HF as the cause of death, all deaths that are directly or indirectly caused by HF or its treatment should be included.36 An example would be a patient with HF who dies of renal failure secondary to the HF who is then coded with renal failure as the cause of death.
So HF death might result in an aetiological cause being coded (such as myocardial infarction) or by a related cause subsequent to HF such as renal failure or respiratory arrest, with HF listed as an additional cause. Given the lack of sensitivity of heart failure death recording, cause-specific death will be defined in two ways. Firstly, by a ICD-10 code for HF (I50) as the primary 'underlying cause of death' or as any of the 'recorded causes of death' in the ONS record and secondly, by a broader definition including HF as the primary 'underlying cause of death' or as any of the 'recorded causes of death' or an 'other cardiovascular diseases' code used as the primary 'underlying cause of death'. Codes will be based on ICD-10 codes as follows: Heart failure (I50), other cardiovascular (chapter IX 'diseases of the circulatory system' excluding I50) and non-cardiovascular (other ICD-10 chapters excluding chapter 1X).
Date of death will be defined by the first entry in the merged HES-ONS file or CPRD but cause of death will use the merged HES-ONS file.Description: Technical Summary
Heart failure (HF) is a leading cause of hospitalisation and death globally and is reaching epidemic proportions in the UK with predicted further growth as populations' age. HF has diverse aetiological pathways which might be triggered or moderated by wide ranging individual, clinical and environmental risk factors. Whilst UK evidence is limited, prior American studies have suggested that incidence of HF and its outcomes differ among ethnic groups. Furthermore, these disparities have been explained by differences in the risk factors and aetiological pathways leading to heart failure among groups, which may change as a result of population and social dynamics within specific groups. In two phases this study aims to investigate (i) whether there are differences in aetiological or risk factors among ethnic groups with new onset HF in the UK and whether temporal changes exist over 20-years (ii) using Poisson models, investigate whether rates of hospital utilisation and deaths differ over time among ethnic groups (iii) using Cox regression, compare time to death following HF among ethnic groups and (iv) residual life and years of life lost due to HF onset, by ethnic group, will be estimated by quantifying standardised (adjusted) survival in people with and without HF.
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Safety of reducing AB prescribing in primary care. Systematic new evidence from electronic health records — Martin Gulliford ...
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Safety of reducing AB prescribing in primary care. Systematic new evidence from electronic health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Catey Bunce - Collaborator - King's College London (KCL)
Judith Charlton - Collaborator - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)
Xiaohui Sun - Collaborator - King's College London (KCL)Outcomes:
We will analyse as outcomes bacterial infections that might potentially be complications arising from a policy of reducing antibiotic prescriptions in primary care. We will develop a comprehensive listing as part of this research. We will specifically include pneumonia, peritonsillar abscess, mastoiditis, bacterial meningitis, intracranial abscess, empyema and Lemierre's syndrome. We also expect to include septicaemia, toxic shock syndrome, pyelonephritis, osteomyelitis, septic arthritis and Scarlet fever. We will also include as outcomes cause-specific mortality and hospital admissions from these conditions, using linked data for ascertainment.
Description: Technical Summary
Antimicrobial drug resistance (AMR) is a growing threat. Many antibiotic (AB) prescriptions in primary care are unnecessary and the NHS is now incentivising reduced AB prescribing in primary care. This research asks whether it is safe to reduce AB prescribing in primary care? Is there a risk that bacterial infections might be more frequent if ABs are prescribed less often? We will systematically identify a comprehensive list of safety outcomes relevant to a policy to reduce overall AB utilisation in primary care. Case definitions will be developed. A cohort study will be conducted using electronic health records (EHRs) from the Clinical Practice Research Datalink (CPRD) with linked hospital episode, mortality and deprivation data. At population- (general practice-) level, we will estimate the incidence of each safety outcome by level of AB prescribing. At individual-level, we will conduct a series of epidemiological studies to evaluate relative and absolute risks of safety outcomes, allowing for confounding by indication using appropriate epidemiological methods. We will obtain estimates for the primary care population stratified by age-group, gender, comorbidity status, smoking, deprivation and, in older adults, frailty level using e-Frailty index.
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Comparisons of Staphylococcus aureus infection and other outcomes between users of angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers: lessons for COVID-19 from a nationwide cohort study — Laurie Tomlinson ...
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Comparisons of Staphylococcus aureus infection and other outcomes between users of angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers: lessons for COVID-19 from a nationwide cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-08
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Corresponding Applicant - University of Tsukuba
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Bidulka - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Hospitalisation with a diagnosis of S.Aureus infection; Sepsis due to S.Aureus (ICD-10 code A41.0).
Description: Technical Summary
We aim to investigate the association between angiotensin converting enzyme inhibitor (ACEI) prescription and Staphylococcus Aureus (S.Aureus) infection in a cohort study using the Clinical Pracice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES). Among adult patients in HES-linked CPRD from April 1997 to March 2017, we will define users of ACEIs. We consider users of angiotensin II Receptor Blockers (ARBs) as an active comparator group. We will conduct a multivariable Cox regression analysis to compare the ACEI users and ARB users for the first incidence of hospitalisation with a diagnosis of S.Aureus infection. To examine the specificity of the association between ACEI and S.Aureus infection, we will compare the two groups for the incidence of hospitalisation with a diagnosis of sepsis due to other organisms.
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Evaluation of the patterns of presentation and treatment of cough in order to understand the prevalence and epidemiology of chronic cough: a preliminary investigation — Haya Langerman ...
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Evaluation of the patterns of presentation and treatment of cough in order to understand the prevalence and epidemiology of chronic cough: a preliminary investigation
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-06
Organisations:
Haya Langerman - Chief Investigator - Merck Sharp & Dohme - UK
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Alyn Morice - Collaborator - Hull York Medical School
Craig Currie - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Robert Boggs - Collaborator - Merck Sharp & Dohme - UK
Surinder Birring - Collaborator - King's College London (KCL)Outcomes:
The pattern of cough presentation will be characterised as follows:
1. The number of people with a record for cough in the study period
2. The number of people with a Read code indicative of chronic cough recorded within the study period
3. The number of people with a record for cough within the wash-in period
4. The number of people with a Read code indicative of chronic cough recorded within the wash-in period
5. The mean number of cough diagnoses per person-year for the following periods:
a) Wash-in period
b) Study period
c) 1st March 2015 to 29th February 2016
6. The number of people with a record indicative of cough recorded within the wash-in or study period that is followed by one or more subsequent records more than 8 weeks after the first record but on or prior to the end of the observation period.
7. Distribution of the time between first Read or ICD-10 code indicative of cough recorded in the study period and all subsequent cough records prior to end of the observation period.
8. Distribution of the time between all Read or ICD-10 codes indicative of cough recorded within the wash-in period and the first cough diagnosis recorded in the study period.
9. Distribution of the time between index date and first outpatient attendance for those patients who are eligible for linkage to HES outpatient data.
10. The mean number of outpatient attendances per person-year for patients eligible for linkage to HES outpatient data for the following periods:
a) Wash-in period
b) Study period
c) 1st March 2015 to 29th February 2016
This will be calculated overall and by outpatient department.
11. Classification of the first cough record within the study period by:
a) Duration (as identified from the Read term or ICD-10 code description)
i. Acute
ii. Chronic
iii. Unspecified
b) Cough type (as identified from the Read term or ICD-10 code description)
i. Productive
ii. Dry
c) Potential underlying cause (as described below)Description: Technical Summary
In this retrospective cohort study, we aim to understand the epidemiology of cough and develop an algorithm to identify chronic cough. The study period will be from 1st March 2014 to 28th February 2015, with an observation period from 1st March 2013 to 29th February 2016 enabling cough episodes to be detected that start or end outside the study period. Research-quality patients will be selected if the later of their registration date and practice up-to-standard date occurs </=1st March 2013; they are alive on 1st March 2014; and the earlier of their transferring out (for reasons other than death) and last data-collection date occurs on or after 29th February 2016 (denominator population). In phase I of the study, people with one or more record of cough within the study period will be characterised in terms of their pattern of presentation and probable aetiology. In phase II, repeated cough records in CPRD will be grouped as episodes of possible recurrent or chronic cough using the information gathered in phase I. Data will be summarised using descriptive statistics. The period prevalence of chronic cough will be calculated by dividing the number of patients with chronic cough within the study period by the denominator population.
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Prevalence of current asthma in the UK and changes over time with treatment — Jennifer Quint ...
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Prevalence of current asthma in the UK and changes over time with treatment
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College LondonOutcomes:
Prevalence of current asthma
Prevalence of patients with ?1 exacerbation
Prevalence of the use of asthma drugs
Temporal changes of asthma drug useDescription: Technical Summary
The object of this study is to estimate an up-to-date prevalence of current asthma in the UK, and the temporal trends in annual prevalence over the past two decades. Annual prevalence will be stratified by age, gender, region, socioeconomic status (for patients with linked IMD data), asthma medication and asthma severity. Current asthma patients will be identified, using validated Read codes, between 2000 and 2017. The overall annual number of patients registered in the CPRD will be used as the denominator. Annual prevalence and temporal trends of patients experiencing ?1 asthma attack per year will also be estimated (only patients with linked HES data).
According to clinical guidelines, asthma patients should have their asthma medication changed according to their symptoms, however, it is not known how often this occurs in clinical practice (especially whether patients have their medication reduced when their disease is stable). To determine this, we will carry out a descriptive historical cohort study; asthma patients will be categorised by their asthma medication (according to UK clinical guidelines) in the 12-months leading up to their study start date. PatientÂs medication category will then be categorised again every 12 months thereafter, this will capture temporal changes in medication categorisation.
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Gout and Neurodegenerative Disorders: A retrospective cohort study in the Clinical Practice Research Datalink — Lorna Clarson ...
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Gout and Neurodegenerative Disorders: A retrospective cohort study in the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-20
Organisations:
Lorna Clarson - Chief Investigator - Not from an Organisation
Lorna Clarson - Corresponding Applicant - Not from an Organisation
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Christian Mallen - Collaborator - Keele University
Edward Roddy - Collaborator - Not from an Organisation
Louise Crowley - Collaborator - Keele University
Rebecca Whittle - Collaborator - Keele UniversityOutcomes:
We aim to quantify the risk neurodegenerative disorders (Parkinsonâs disease, multiple sclerosis and Alzheimerâs disease) among patients with gout.
Description: Technical Summary
Objectives
This study aims to estimate the risk of neurodegenerative conditions (Parkinsonâs Disease, dementia, and Multiple Sclerosis) in gout patients compared to those without gout and determine if this is affected by urate-lowering therapies (ULT).Methods
We will identify incident gout cases between 1997 and 2016 from primary care using Read codes. All patients with a history of gout or evidence of ULT before the study start date will be excluded. Each gout case will be matched to 5 controls on age, gender, general practice and follow-up in CPRD. Among those with gout, we will assess the impact of ULT on fracture and utilise landmark analysis and propensity score matching to account for immortal time bias and confounding by indication.
Data analysis
The absolute rate of neurodegenerative disorders per 10,000 person-years will be calculated for cases and controls. Cox Proportional Hazards Regression will model time-to-event, and estimate the hazard ratio associated with exposure to gout. A multivariable regression model will be used to adjust for potential confounders. Subgroup analyses investigating the affect of ULT exposure (defined as a minimum of 6 months ULT) on neurodegenerative disorder risk in the gout cohort will be performed using landmark analysis.
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Utilization and Adverse Outcomes of Ondansetron and Fluconazole Therapy during Pregnancy — Samy Suissa ...
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Utilization and Adverse Outcomes of Ondansetron and Fluconazole Therapy during Pregnancy
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Anat Fisher - Collaborator - University of British Columbia
Carolina Moriello - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Colin Dormuth - Collaborator - McGill University
J. Michael Paterson - Collaborator - Institute for Clinical Evaluative Sciences ( ICES )
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Stillbirth - Spontaneous abortion - Induced abortion (including termination of pregnancy due to foetal anomaly) - Congenital malformation
Description: Technical Summary
Ondansetron is a selective antagonist of the serotonin receptor subtype 5-HT3, having antiemetic properties to treat nausea. Though it is not indicated for nausea and vomiting in pregnancy, it is often prescribed to pregnant women. However, there are potentially severe effects on the foetus. Fluconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 alpha-demethylation used to treat candidiasis. High doses of fluconazole (400 - 800 mg/day) have been associated with increased risk for congenital malformations. However, questions remain regarding its safety in relation to exposure and dose. To further examine the effect of these two drugs on pregnant women and foetuses, we will conduct a retrospective, population-based cohort study. Pregnancies will be divided into several cohorts (live births, stillbirths, induced abortions, and spontaneous abortions) and use of ondansetron and fluconazole in each group will be assessed. The congenital abnormalities of ondansetron will be compared to diclectin, dimenhydrinate, chlorpromazine, metoclopramide, prochlorperazine, or promethazine. The effects of fluconazole will be compared to polyene antifungals, imidazoles, or triazoles. Where possible, matched sibling cohorts will be used to account for confounding from genetic or socioeconomic factors.
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An observational retrospective cohort analysis in adults with systemic lupus erythematosus/lupus nephritis to describe the characteristics of disease severity, disease activity (flare frequency), treatment, costs, and outcomes — Heide Stirnadel...
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An observational retrospective cohort analysis in adults with systemic lupus erythematosus/lupus nephritis to describe the characteristics of disease severity, disease activity (flare frequency), treatment, costs, and outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-08
Organisations:
Heide Stirnadel-Farrant - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Julia Langham - Corresponding Applicant - Maverex Ltd
Mihail Samnaliev - Collaborator - PHMR Associates
Sharada Weir - Collaborator - Maverex Ltd
Xia Wang - Collaborator - Astra Zeneca Inc - USAOutcomes:
SLE disease severity
- SLE flare activity
- Comorbidities
- Organ system involvement
- Mortality
- Medicinal treatment
- Healthcare resource utilisation
- Cause of deathDescription: Technical Summary
Objectives: (1) The primary objective is to (1.1) characterise a population-based cohort of systemic lupus erythematosus/lupus nephritis (SLE/LN) patients; and describe (1.2) disease severity (mild, moderate, severe); and (1.3) disease activity (frequency of flares, length of remission periods, severity of flares).
(2) Secondary objectives are to describe (2.1) medicinal management, (2.2) key outcomes (comorbidities and organ system involvement) and (2.3) healthcare resource utilisation (HCRU) in SLE/LN patients, by disease severity and disease activity.Methods: This study is a non-interventional (observational) retrospective cohort study of adult patients with SLE/LN in the UK identified in the CPRD between 2005-2015.
Analysis: Standard exploratory and descriptive analyses will be used to gain an understanding of the qualitative and quantitative nature of the data collected and of the characteristics of the sample studied. Time to event (such as flare and mortality) will be estimated using Kaplan-Meier (KM) survival analysis and plotted using KM survival curves. We will report median time to event and incidence rates at select time points (e.g., 1, 3, 6 months). Cox proportional hazard regression models will be considered to control for covariates and to estimate the hazard of event and differences in the hazard across subgroups/strata.
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Dosage regimens and interrupted treatment in heart failure: a national retrospective cohort study in primary care. — Carl Heneghan ...
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Dosage regimens and interrupted treatment in heart failure: a national retrospective cohort study in primary care.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-20
Organisations:
Carl Heneghan - Chief Investigator - University of Oxford
Niklas Bobrovitz - Corresponding Applicant - University of Oxford
Jeffrey Aronson - Collaborator - University of Oxford
Kamal Mahtani - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of OxfordOutcomes:
Primary:
- Mortality
- All-cause emergency hospital admissions
- Cardiovascular-related emergency hospital admissions
Secondary:
- Treatment interruptions in heart failure medication
- Defined daily dose of heart failure medicationDescription: Technical Summary
Heart failure (HF) is a leading cause of morbidity and mortality globally, and a major financial burden on health systems. Current medical guidelines recommend use of several medications to help manage patients with heart failure and a reduced ejection fraction. Studies have shown that the use of these medications in recommended doses improves survival, reduces hospital admissions, and can reduce health costs. However, it is unclear if patients in UK primary care receive adequate supplies of medications and whether target doses are being achieved. Patients may not receive or take medications correctly or at all, for various reasons related to the patient, the prescriber, or the healthcare system:
- they may not adhere to treatment, for example because of forgetfulness or adverse reactions;
- they may receive conflicting advice from carers;
- they may have limited access to health care, owing to geography or cost;
- repeat prescriptions may not be requested or issued.
However, before studying these factors in UK primary care we must first determine the extent to which interruptions in treatment occur and if they are associated with patient outcomes.We shall therefore describe the proportion of patients with reduced ejection fractions experiencing interrupted treatment (days without pills) and determine the extent to which their prescribed doses meet guideline recommendations. We will then examine the association between interrupted treatment and prescribed dosage regimens and important patient outcomes (emergency hospital admissions and mortality) using Cox proportional hazards modelling adjusted for key co-variates. We will also examine if patient characteristics are associated with interrupted treatment and dosage regimens using Cox proportional hazards modelling and logistic regression. The results of this study could be used to inform quality improvement initiatives and improved management of patients with heart failure in UK primary care.
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Identifying coincident drugs that alter headache progression and remission. — Zameel Cader ...
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Identifying coincident drugs that alter headache progression and remission.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-05
Organisations:
Zameel Cader - Chief Investigator - University of Oxford
Zameel Cader - Corresponding Applicant - University of Oxford
Alejo Nevado-Holgado - Collaborator - University of Oxford
Alice Fuller - Collaborator - University of Oxford
Anthony Nash - Collaborator - University of Oxford
Caleb Webber - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Simon Lovestone - Collaborator - University of OxfordOutcomes:
Headache/ migraine resolution (Primary)
- Prescription analgesic use persistence (Primary)
- Number of neurology referrals (Secondary)
- Cessation of all migraine preventative use. (Secondary)
- Number of emergency admissions (Secondary)
- GP consultation rate (Secondary)Description: Technical Summary
We will examine drugs, not used in the treatment of migraine, that have been prescribed for another indication to assess whether this treatment is associated with remission or relapse of headache by undergoing a cohort and two nested case-control studies. The cohort longitudinal study will be used to describe the use of prescription analgesic and migraine preventative treatment patterns over time and confirm the efficacy of migraine preventatives in headache remission.
Estimates in efficacy of headache remission will be calculated over commonly prescribed drugs, not used in migraine treatment and prescribed to the patient for another indication. We will use Cox proportional hazards regression where the outcomes will be time to remission and time to relapse before moving onto multivariate Cox regression with time dependent covariates to explore potential nonlinear time trends.
Nested case-control studies will be used to explore the association between headache remission, persistence and relapse with prescription of drugs not used in migraine. Conditional logistic regression will be used to calculate odds ratio of a headache moving into remission or a patient moving into relapse. Critical variables will be controlled for and confounding factors will be taken into account in both cohort and case-control analysis.
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Predicting Type-II Diabetes Using Primary Care information — Spiros Denaxas ...
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Predicting Type-II Diabetes Using Primary Care information
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-27
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Spiros Denaxas - Corresponding Applicant - University College London ( UCL )
Anoop Shah - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Maria Pikoula - Collaborator - University College London ( UCL )Outcomes:
The primary outcome measure of the study will be the first incident diagnoses of type 2 diabetes. We will define T2D using a previously published and validated algorithm (Shah A. et al 2015).
Description: Technical Summary
Type 2 diabetes (T2D) prevalence is rapidly increasing and is associated with a substantial burden of disease and significant costs to healthcare systems worldwide. Risk prediction models have been developed to assist clinicians with the clinical management of patients by identifying those at a higher risk of developing T2D and that could potentially benefit from targeted healthcare interventions or lifestyle changes. Such models are based on classical regression-based techniques and utilize a single measurement from a set of a priori-defined predictors. Novel methodological approaches are required to take advantage of the richness and breadth of the clinical data and biomarkers available in patient records and combine them with novel statistical approaches to create accurate T2D risk prediction tools.
In this study, we implement and evaluate a T2D risk prediction model using a pre-defined set of clinical markers and supervised machine learning approaches such as decision trees, support vector machines and probabilistic graphical models in order to predict the risk of developing T2D. We will compare our results with findings from existing validated T2D risk prediction models and clinical knowledge from published literature.
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Is smoking a risk factor for autoimmune hepatitis? An English registry-based case-control study using data from the Clinical Practice Research Datalink and linked Hospital Episode Statistics — Joe West ...
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Is smoking a risk factor for autoimmune hepatitis? An English registry-based case-control study using data from the Clinical Practice Research Datalink and linked Hospital Episode Statistics
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-06
Organisations:
Joe West - Chief Investigator - University of Nottingham
Lisbet Gronbaek - Corresponding Applicant - Aarhus University Hospital
Colin Crooks - Collaborator - University of Nottingham
Harmony Otete - Collaborator - University Of Central Lancashire
Peter Jepsen - Collaborator - Aarhus University Hospital
Timothy Card - Collaborator - University of NottinghamOutcomes:
Odds ratio of developing autoimmune hepatitis for smokers vs. non-smokers.
Description: Technical Summary
Using data from the Clinical Practice Research Database and linked Hospital Episode Statistics, the objective of the study is to conduct a matched case-control analysis evaluating the association between smoking and the risk of autoimmune hepatitis. Individuals with a first-time diagnosis of autoimmune hepatitis 1997-2017 will be included as cases, and matched individuals without autoimmune hepatitis will be included as controls. Cases and controls will be classified as 'smokers' or 'non-smokers'. The odds ratio will be calculated with 95% confidence intervals for the association between autoimmune hepatitis and smoking using logistic regression. Analyses will be adjusted for potential confounding from age, sex, and socioeconomic status.
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Blood eosinophil and creatine reactive protein as biomarkers of response to inhaled corticosteroids in COPD — Frank de Vries ...
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Blood eosinophil and creatine reactive protein as biomarkers of response to inhaled corticosteroids in COPD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-08
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Anthonius de Boer - Collaborator - Utrecht University
Frits Franssen - Collaborator - CIRO
Johanna Driessen - Collaborator - Utrecht University
Miel (Emiel) Wouters - Collaborator - CIRO
Olorunfemi Oshagbemi - Collaborator - Utrecht UniversityOutcomes:
Acute exacerbations of COPD; COPD Hospitalisations; All-cause mortality.
Description: Technical Summary
Chronic obstructive pulmonary disease (COPD) is a medical condition characterized by enhanced airway inflammation, and is known to be responsible for mortality and morbidity of millions of individuals worldwide. Recent findings suggest that eosinophils have a key role in the disease pathophysiology. C-reactive protein have also been identified to be elevated in patients with COPD exacerbation. Exacerbations of COPD are the primary outcome as these greatly affect a patient's quality of life. The benefits of inhaled corticosteroids (ICS) to reduce exacerbations have mainly been observed in patients having eosinophil airways inflammation. Similarly, some benefits of ICS have been reported in patients with elevated C-reactive protein levels. Thus, the purpose of this study is to explore the use of ICS and the risk of acute exacerbations, hospitalisations and all-cause mortality among COPD patient with elevated levels of eosinophil (>0.34 x 109 cells/L) and CRP (>3 mg/L). This study will be a cohort study of COPD patients over 40 years from January 2005 to January 2014. Patients with at least one blood eosinophil and CRP measurement at baseline will be included in the study. The primary outcome of the study will be a COPD acute exacerbation (secondary outcomes include: COPD-related hospitalizations or death). We will evaluate the risk of study outcomes stratified by ICS exposure, sex, and age category. Current ICS users will be stratified absolute blood eosinophil count and C-reactive protein using Cox regression analysis (SAS 9.4). We will also adjust for never, past and recent ICS use among current users stratified by eosinophil counts, CRP, gender and age categories for all outcomes. Kaplan-Meier curves will be used to show the differences in survival times with different blood eosinophil counts and CRP level among current users of ICS.
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Replication of "Identification of impaired fasting glucose, healthcare utilization and progression to diabetes in the UK using the Clinical Practice Research Datalink (CPRD)". — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Replication of "Identification of impaired fasting glucose, healthcare utilization and progression to diabetes in the UK using the Clinical Practice Research Datalink (CPRD)".
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-13
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Diabetes onset during follow-up.
Description: Technical Summary
This objective of this protocol is to replicate the study: 'Identification of impaired fasting glucose, healthcare utilization and progression to diabetes in the UK using the Clinical Practice Research Datalink (CPRD)' by Hong et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to ascertain which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Hong paper describes rates of progression to diabetes among patients with impaired fasting glucose (IFG) in the UK between 2001-2012. We will replicate this outcome. Diabetes onset was ascertained by two READ codes for diabetes or a combination of READ code for diabetes and a prescription for anti-hyperglycemic therapies. All patients were followed from the index date until the earliest of the following events: ascertainment of diabetes, death, migration out of general practice, or end of study (31 December 2012).
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Utilisation pattern of hormonal replacement therapy in UK general practice between 2000 and 2016 — Susan Jick ...
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Utilisation pattern of hormonal replacement therapy in UK general practice between 2000 and 2016
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-27
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Marlene Rauch - Corresponding Applicant - University of Basel
Christoph Meier - Collaborator - University of Basel
Manon Moser - Collaborator - University of Basel
Theresa Burkard - Collaborator - University of BaselOutcomes:
Hormonal replacement therapy use
- Hysterectomy
- Venous thromboembolic events
- Migraine
- Breast cancer
- Myocardial infarction
- Bilateral oophorectomy
- Statin use
- Ischaemic stroke
- Menopausal symptoms
- Psychiatric problems
- AsthmaDescription: Technical Summary
We plan to first perform a descriptive study in which we describe utilisation patterns of estrogen replacement therapy with or without progesterone (henceforth to be referred to as HRT) in postmenopausal women between 2000 and 2016. We will estimate the prevalence of HRT use by calendar year in women aged 40-79 years overall and by therapy type, estrogen application route, and estrogen dosage. We will further calculate incidence rates (IR) of new HRT use each calendar year in women aged 40 79 years overall, as well as categorized by age groups and geographical region.
We will then describe prevalence of characteristics in prevalent HRT users and non users in each year by performing a cross-sectional study in each calendar year. We will further describe mean age, ethnicity, lifestyle (smoking, alcohol consumption), body mass index (BMI), socioeconomic status (SES), certain comorbidities, and co-medications of prevalent HRT users and non users in each year.
This study will be the first to describe HRT utilisation patterns in the United Kingdom (UK) after 2005.
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Identifying predictors of adherence to diabetes medications: an observational cohort study — Andrew Farmer ...
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Identifying predictors of adherence to diabetes medications: an observational cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-20
Organisations:
Andrew Farmer - Chief Investigator - University of Oxford
Beverley Shields - Corresponding Applicant - University of Exeter
Andrew Hattersley - Collaborator - University of ExeterOutcomes:
Primary: 12 month Medical possession ratio on second line diabetes therapy
Secondary: 12 month persistenceDescription: Technical Summary
Adherence to diabetes medications is a clear predictor of glycaemic response: patients with <80% prescription coverage have a worse response 6 months after starting therapy. It is therefore important for the clinician to determine patients at risk of non-adherence to enable delivery of interventions aimed at improving agreed medicines use.
We aim to investigate factors that predict adherence to medicines, assessed by prescriptions issued, including clinical features (age, BMI, gender, ethnicity), socioeconomic status, number of diabetes or other routine medications, and comorbidities. We will also study patterns of past prescription coverage on first line metformin treatment to assess whether this is a predictor of future adherence on second and third line therapies. Initial analysis will focus on predicting adherence as measured by medical possession ratio over the first year of treatment, but additional analysis will investigate if predictors change when studying other measures such as persistence of prescription pick-up. We will restrict our analysis based on patients starting a new diabetes therapy from 2004 onwards, allowing for higher quality data (when QOF returns came into practice) and reflecting modern prescribing practices.
We will develop statistical models of predictors of adherence using regression techniques (linear when examining predictors of adherence on a continuous scale, logistic when examining predictors of <80% v >80% adherence). The long-term aim will be to implement such models in clinical practice to flag-up patients requiring additional support.
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5-alpha reductase inhibitors for benign prostate hyperplasia and the risk of urological cancers and other non-cancer adverse events — Blánaid Hicks ...
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5-alpha reductase inhibitors for benign prostate hyperplasia and the risk of urological cancers and other non-cancer adverse events
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-03-14
Organisations:
Blánaid Hicks - Chief Investigator - Queen's University Belfast
Blánaid Hicks - Corresponding Applicant - Queen's University Belfast
Anton Pottegard - Collaborator - University Of Southern Denmark
Chris Cardwell - Collaborator - Queen's University Belfast
Chris Hill - Collaborator - Belfast Health and Social Care TrustOutcomes:
Primary analyses will investigate the use of 5alpha-reductase inhibitors and risk of urological cancer (based on ICD codes from NCDR, by site, histology and stage/Gleason score), diabetes (determined by Read codes from CPRD Gold) and dementia/Alzheimer's disease (determined by Read codes from CPRD Gold). Secondary hypothesis will investigate osteoporosis, cancer at other sites and cardiovascular outcomes (including heart failure, myocardial infarction, stroke and all-cause and cardiovascular specific-mortality from GP & ONS records).
Description: Technical Summary
Evidence from preclinical and observational studies suggest that 5alpha-reductase inhibitors (5ARIs) may increase the risk of urological cancers. Similarly, emerging evidence suggests 5ARIs may be associated with a number of non-cancer adverse events, such as dementia and diabetes. However few observational studies have been conducted and these have had a number of limitations. Thus, the objective of this study will be to assess these adverse events by assembling a cohort of patients who received a diagnosis of benign prostatic hyperplasia from January 1 1998, from the CPRD, linked to the National Cancer Data Repository and ONS mortality data. Time-dependent Cox proportional hazard models will be used to estimate hazard ratios and 95% confidence intervals of adverse events associated with the use 5ARIs, compared with non-use of 5ARIs Secondary analyses will investigate whether the risk varies according to cumulative duration of use and time since medication initiation. This study will provide further evidence regarding these potential adverse associations, providing concerned stakeholders with important information, enabling the assessment of the risks and benefit of these medications.
Source
2018 - 02
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Risk and clinical impact of nontuberculous mycobacterial disease (NTM) within the general and chronic respiratory disease UK primary care patient populations, 2006-2016. — Jennifer Quint ...
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Risk and clinical impact of nontuberculous mycobacterial disease (NTM) within the general and chronic respiratory disease UK primary care patient populations, 2006-2016.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-15
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Eleanor Axson - Corresponding Applicant - Imperial College London
Chloe Bloom - Collaborator - Imperial College London
Eleanor Axson - Collaborator - Imperial College LondonOutcomes:
First all-cause hospitalisation for Specific Aim #2; All-cause death from ONS data for Specific Aim #3.
Description: Technical Summary
The objective of this project is to characterise patients who have developed clinical disease secondary to NTM infection and compare their morbidity and mortality to patients without NTMD. A secondary analysis specifically looking at patients with comorbid CRD and NTMD will be undertaken, should numbers allow. CRD will be defined as having at least one of asthma, bronchiectasis, COPD, cystic fibrosis, or interstitial lung disease. We will conduct a nested case-control study to characterise risk factors for NTMD in both the general and CRD populations. We will conduct time-to-event analysis to compare mortality and hospitalisations in the general and CRD populations to the appropriate general populations. Also, if numbers allow, we will report based on specific CRD, including COPD and bronchiectasis.
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Investigating pregnancies without recorded outcomes in the Clinical Practice Research Datalink / London School of Hygiene and Tropical Medicine Pregnancy Register, with the aim of improving validity. — Jennifer Campbell ...
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Investigating pregnancies without recorded outcomes in the Clinical Practice Research Datalink / London School of Hygiene and Tropical Medicine Pregnancy Register, with the aim of improving validity.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-15
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachael Williams - Collaborator - CPRD
Sara Thomas - Collaborator - Not from an OrganisationOutcomes:
All end of pregnancy outcomes including live deliveries, stillbirths, early pregnancy losses (spontaneous and induced); Evidence of pregnancy, as defined by Read and Gemscript and ICD codes.
Description: Technical Summary
The Pregnancy Register algorithm generates a list of all pregnancies identified in CPRD GOLD. A record in the register represents a pregnancy episode and includes information on pregnancy start and outcome. However, there are approximately one million pregnancies where no outcome has been identified. Scenarios have been identified based on the algorithm's logic and how the data is structured which may explain this. The scenarios describe four problems; (i) real pregnancies where the outcome was not recorded in CPRD GOLD, (ii) ongoing pregnancies at the end of available follow-up, (iii) the patient may not have been pregnant, or (iv) the pregnancy episode may be made up of records which are really part of another pregnancy. Analysis will use an algorithmic approach to query CPRD GOLD and linked datasets to look for supporting evidence for each of these scenarios. Evidence will then be used to improve the Pregnancy Register algorithm to reduce the occurrence of pregnancies without outcome and increase the usefulness of this resource.
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Causes of mortality in patients with comorbid COPD and heart failure in the United Kingdom, 2005-2017 — Jennifer Quint ...
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Causes of mortality in patients with comorbid COPD and heart failure in the United Kingdom, 2005-2017
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-28
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Eleanor Axson - Corresponding Applicant - Imperial College London
Alicia Gayle - Collaborator - Imperial College London
Chloe Bloom - Collaborator - Imperial College LondonOutcomes:
Mortality in ONS using the derived variable as well as information from all causes mentioned on the death certificate (proposed causes).
Description: Technical Summary
There have been many studies investigating whether having both COPD and HF results in an increased risk of mortality compared to patients with only one of these conditions; however, as of yet there is no consensus. We will use linked CPRD and ONS data to investigate changes in causes of death. We will undertake descriptive analyses to investigate changes in causes of death over time. We will analyse rates of death associated with COPD, HF, and comorbid COPD-HF stratified by age and sex.
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Real-World Evidence in Oncology in England: Treatment patterns and Healthcare Resource Utilization — Meng Wang ...
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Real-World Evidence in Oncology in England: Treatment patterns and Healthcare Resource Utilization
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-23
Organisations:
Meng Wang - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sreeram Ramagopalan - Corresponding Applicant - London School Of Economics & Political Science
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )Outcomes:
Incidence rates of adverse events (AEs): Number of new cases, including most common disease related symptoms and treatment related AEs per person
time at risk over the follow-up period. Conditions of interest will be identified from CPRD and HES APC datasets through Read and ICD-10 codes (see Appendix 2 for codes and conditions). Treatment related AEs will be identified after initiation of systemic treatments and follow up time will end after treatment discontinuation.
- Healthcare resource utilisation: During follow-up, usage of healthcare will be summarised in patients with at least 6 months follow-up, including GP visits, referrals to specialists, lab tests performed, hospital admissions, length of inpatient stay, and in-hospital procedures performed.Description: Technical Summary
According to Cancer Research UK, there were around 357,000 new cases of cancer in the United Kingdom (UK) in 2014, however there is limited recent real-world data on cancer patients in the UK. The rationale of this study therefore is to fill this evidence gap and describe the treatment patterns and healthcare resource use of patients with a number of cancers in England. Specifically, the aims are to understand patient characteristics (demographic and clinical) and survival rates. In order to do this, the study will link data from the Clinical Practice Research Datalink, Hospital Episodes Statistics, National Cancer Registration and Analysis Service and Office of National Statistics (ONS) in order to provide the most accurate data on patient diagnoses and clinical characteristics.
The number and proportion of patients receiving systemic anti-cancer treatment in each of the disease areas of interest will be described. Rates of adverse events following the initiation of treatment will be described by person time at risk. The healthcare resource use of patients following initiation of treatment will also be described including rates of GP attendances, hospital admissions and length of hospital stays. This descriptive analysis will provide an up-to-date picture of the treatment and potential unmet needs of patients with these cancers in England.
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Characteristics of patients initiating and switching oral anticoagulants (OACs) for non-valvular atrial fibrillation (NVAF) in the UK general practices — Michael Marcus ...
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Characteristics of patients initiating and switching oral anticoagulants (OACs) for non-valvular atrial fibrillation (NVAF) in the UK general practices
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-19
Organisations:
Michael Marcus - Chief Investigator - University of Liverpool
Michael Marcus - Corresponding Applicant - University of Liverpool
Chris D Poole - Collaborator - Digital Health Labs Limited
Gregory Y H Lip - Collaborator - University of Birmingham
Naj Rotheram - Collaborator - Boehringer-Ingelheim - UKOutcomes:
For the purpose of this analysis, the date of anticoagulation treatment initiation in the study period will determine exposure cohorts. The first prescription date for the following OACs: dabigatran, rivaroxaban, apixaban, edoxaban and warfarin will be considered as the index for assessing the baseline characteristics. For patients with multiple distinct period of exposure to any one of the OACs only the baseline characteristics at the first distinct period will be assessed. Covariates Demographic variables: Sex, age, ethnicity, year of AF diagnosis, time since diagnosis; Clinical variables: Body mass index (BMI), smoking history, alcohol consumption; Comorbidities include: congestive heart failure, hypertension, type II diabetes mellitus, vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque), history of stroke/TIA/TE, history of major bleeding, chronic liver disease and chronic kidney disease (including most recent creatinine clearance); CHA2DS2-VASc, HAS-BLED and SAMe-TT2R2S scores In addition history of cardioversion and dyspepsia symptoms will be considered as comorbidities of interest, utilisation of acetylsalicylic acid (ASA), beta-blockers, amiodarone and verapamil.
Description: Technical Summary
Warfarin is the mainstay of therapy to reduce thromboembolic stroke risk in patients with non-valvular atrial fibrillation (NVAF). Major limitations associated with the use of warfarin include; a narrow therapeutic window, regular monitoring requirement, multiple drug and food interactions and the risk of haemorrhage. Warfarin alternatives, New oral anticoagulants (NOACs; Dabigatran, Rivaroxaban, Apixaban and Edoxaban) are simpler to dose and do not require therapeutic monitoring. The marketing authorisations for each NOAC are subtlety different creating potential channelling biases which largely remain unaddressed. Clinicians require comparative data to make informed oral anticoagulant prescribing decisions. Real-world data studies are crucial to our understanding of OACs utilisation outside clinical trials. Clinical trial populations may not be universally representative of the general population who are prescribed OACs in routine clinical practice. In addition, the risk profile of patients given NOACs to warfarin may have changed over time. The aim of this study is to utilise real-world data available from the Clinical Practice Research Datalink (CPRD) to gain detail insight on the evolution of baseline characteristics of anticoagulated patients with atrial fibrillation, prescribed different OACs for the first time.
Source -
Distribution of COPD patients by COPD GOLD Classification and their primary health-care and respiratory medication utilization in the Clinical Practice Research Datalink (CPRD) — Leah Sansbury ...
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Distribution of COPD patients by COPD GOLD Classification and their primary health-care and respiratory medication utilization in the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-19
Organisations:
Leah Sansbury - Chief Investigator - GlaxoSmithKline - UK
Leah Sansbury - Corresponding Applicant - GlaxoSmithKline - UK
Chanchal Bains - Collaborator - GlaxoSmithKline - UK
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.Outcomes:
Patient demographics
- Respiratory history and disease severity
- Respiratory medications
- Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations)Description: Technical Summary
The purpose of this study is to characterize a COPD population treated in primary care into the Global initiative for chronic Obstructive Lung Disease (GOLD) 2013 categories (GOLD A-D) based on patients' symptomatic assessment, spirometric classification, and risk of exacerbations. Category A: low risk (for COPD exacerbations), less symptoms; B: low risk, more symptoms; C: high risk, less symptoms; D: high risk, more symptoms. The GOLD 2013 strategy document also proposes suitable first and secondary choice pharmacologic therapies for each of these groups, however, despite these evidence-based guidelines, observational studies have shown that routine practice of prescribing treatment for COPD is not always aligned with these recommendations. This large population-based observational study aims to characterize a COPD population treated in primary care into the GOLD 2013 groups, and to describe the prescribing practices of respiratory medication by physicians in the U.K. according to those groups. Further, demographic and clinical characteristics, outcomes and health care utilisation will be described by GOLD 2013 group.
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Prevalence of gas trapping in COPD - estimation from spirometry — Jennifer Quint ...
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Prevalence of gas trapping in COPD - estimation from spirometry
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-05
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Amany Elbehairy - Collaborator - Royal Brompton Hospital
Nicholas Hopkinson - Collaborator - Imperial College LondonOutcomes:
Lung volume reduction surgery
Description: Technical Summary
The measurement of residual volume (RV) - an indicator of the degree of pulmonary gas trapping - is technically demanding and requires specific devices with additional costs. Patients with COPD who have a high enough RV are more likely to benefit from lung volume reduction surgery or another similar procedure. A model to predict RV from forced spirometry measurements (FEV1, FVC, FEV1/FVC) has been recently validated. As a national sample of current practice, we will use linked CPRD GOLD data to undertake a cohort study to provide an accurate estimate of the number of people with COPD who have a high enough RV using this novel equation. This will establish a more accurate estimate of patients who are potentially eligible for lung volume reduction procedures based on the widely available spirometry. Additionally, we will link the information about RV to whether or not these patients have been referred for pulmonary rehabilitation.
The information obtained from this study will be used to inform the development of models and strategies to improve access to this form of treatment and reduce health inequality which can then be used as a national resource.
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The association of concomitant use of potentiating drugs and bleeding risk during treatment with direct oral anticoagulants: a case control study — Anthonius de Boer ...
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The association of concomitant use of potentiating drugs and bleeding risk during treatment with direct oral anticoagulants: a case control study
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-06
Organisations:
Anthonius de Boer - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Helga Gardarsdottir - Collaborator - Utrecht University
Hendrika van den Ham - Collaborator - Utrecht University
Yumao Zhang - Collaborator - Utrecht Institute for Pharmaceutical SciencesOutcomes: none known
Description: Technical Summary
The effect and clinical relevance of drug-drug interaction of DOACs in relation to bleeding is largely unknown.
Objective
To assess the risk of bleeding associated with concomitant use of drugs having pharmacokinetic or pharmacodynamic interactions on the anticoagulant effect of DOACs.Methods
A case control study nested within a cohort of incident users of DOACs. Cases are patients with a first hospital admission for a major bleeding event. For each patient, up to 4 controls will be matched by region, sex, year of birth (+/- 1 year) and index date (the date of major bleeding event). Both cases and controls require to be a current user of DOACs on the index date. Concurrent use will be defined as prescribing of drug that have pharmacokinetic or pharmacodynamic interactions on the anticoagulant effect of DOACs.Data analysis
Differences in baseline characteristics between cases and controls will be assessed by T-tests for continuous variables and Chi-square tests for categorical variables. Conditional logistic regression analysis will be used to estimate the strength of the association between concomitant use of potential interacting medication on the risk of major bleeding, expressed and crude and adjusted odds ratios (ORs) with 95% confidence intervals (CIs).
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Eczema phenotype discovery using cluster analysis techniques in CPRD — Sinead Langan ...
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Eczema phenotype discovery using cluster analysis techniques in CPRD
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-13
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amy Mulick - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Maria Pikoula - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
Eczema (also known as atopic dermatitis or atopic eczema) affects 20% of children and up to 10% of adults (5.8 million people in England) and prevalence is increasing globally. Eczema is a challenging disease characterised by itch, sleeplessness, discomfort, stress and stigma for sufferers and incurs significant costs. Eczema is a very heterogeneous diseases, with groups of clinical, pathophysiological and demographic characteristics called phenotypes.). Currently, there is not much known about the relationship between pathological features, clinical patterns of disease and response to treatment.
In this study, we will use an approach named clustering analysis to try to identify eczema phenotypes in CPRD. Clustering is an exploratory approach in which can be used to identify subtypes in diseases. Cluster analysis to identify eczema phenotypes has been used in smaller studies. However, cluster analysis of a larger patient database could lead to the improved identification and characterisation of eczema phenotypes which would otherwise be grouped into broader disease aggregates.
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Incretin-based drugs and the incidence of cholangiocarcinoma among patients with type 2 diabetes. — Samy Suissa ...
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Incretin-based drugs and the incidence of cholangiocarcinoma among patients with type 2 diabetes.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-06
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Devin Abrahami - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jean-Luc Faillie - Collaborator - Montpellier University Hospital
Nathaniel Bouganim - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Cholangiocarcinoma.
Description: Technical Summary
The incretin-based drugs are typically used as second-to-third line treatments in the management of type 2 diabetes. While they effectively lower blood glucose via the incretin system, there is some evidence that targeting this system may produce unintended effects. Indeed, the incretin-based drugs may be involved in the development of cholangiocarcinoma, through a mechanism potentially mediated by the expression of GLP-1 receptors on cholangiocytes. Patients with intrahepatic cholangiocarcinoma have increased expression of cholangiocytes in tumour tissues, and activation of the GLP-1 receptor via GLP-1 analogues has been shown to proliferate cholangiocytes in vitro and in vivo. To address this, we will assemble a cohort of approximately 190,000 patients newly-treated with antidiabetic drugs between 2007 and 2016, with follow-up until 2017. Use of the incretin-based drugs will be modelled as a time-varying variable, allowing a 1-year lag period for latency. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of cholangiocarcinoma associated with use of DPP-4 inhibitors or GLP-1 analogues, compared with use of 2 or more different antidiabetic drug classes. Secondary analyses will assess whether risk varies by duration of use, time since initiation or by type of cholangiocarcinoma (intrahepatic, extrahepatic or unspecified).
Source - and 14 more projects — click to show
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Determining profiles of musculoskeletal health using electronic health records — Ross Wilkie ...
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Determining profiles of musculoskeletal health using electronic health records
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-13
Organisations:
Ross Wilkie - Chief Investigator - Keele University
Ross Wilkie - Corresponding Applicant - Keele University
Alan Silman - Collaborator - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Clare Jinks - Collaborator - Keele University
Dahai Yu - Collaborator - Keele University
Daniel Prieto-Alhambra - Collaborator - University of Oxford
George Peat - Collaborator - Keele University
Joanne Protheroe - Collaborator - Keele University
Karen Walker-Bone - Collaborator - University of Southampton
Kelvin Jordan - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Stephen Dent - Collaborator - Keele University
Steven Blackburn (Keele) - Collaborator - Keele UniversityOutcomes:
The specific aims are to use statistical models which have been developed from responses to a survey within 11 general practices and with linkage to medical records, to determine national, regional and condition-specific population profiles in musculoskeletal consulters of:
1) Chronic high impact pain
2) Severe pain
3) Musculoskeletal health in general
4) Employment status
5) Work absence
6) Work productivity loss
7) General healthDescription: Technical Summary
The objective is to provide a detailed description of musculoskeletal health in the UK for use by policymakers, healthcare professionals, and the public.
We have undertaken a survey in North Staffordshire which included questions on musculoskeletal health such as length of time with troublesome musculoskeletal pain, severity of pain, problems with everyday life, problems working due to pain, and health in general. The questionnaire was sent to people consulting their GP for common musculoskeletal conditions like osteoarthritis, and site-specific pain like back and shoulder pain. 8000 people responded and gave us consent to link their responses in the survey to their medical records.
We are currently using information in their primary care records such as age, gender, number of consultations for musculoskeletal problems, time since first consultation, pain medications prescribed, other management, and other illnesses, to develop a statistical model to accurately estimate the answers given on their questionnaire.
The best model that we develop will then be applied to primary care information within CPRD to give us estimates of musculoskeletal health in people seeing their doctor for musculoskeletal pain at the national level, and allow us to compare across geographical regions and by level of neighbourhood deprivation.
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Epidemiology of pre-diagnosed rheumatoid arthritis and early classification of high severity at diagnosis — Kristen Ricchetti...
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Epidemiology of pre-diagnosed rheumatoid arthritis and early classification of high severity at diagnosis
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-22
Organisations:
Kristen Ricchetti-Masterson - Chief Investigator - GlaxoSmithKline - USA
Kristen Ricchetti-Masterson - Corresponding Applicant - GlaxoSmithKline - USA
Brian Pence - Collaborator - University of North Carolina at Chapel Hill
James C. Thomas - Collaborator - University of North Carolina at Chapel Hill
Jennifer L. Lund - Collaborator - University of North Carolina at Chapel Hill
John Logie - Collaborator - GlaxoSmithKline - UK
Leigh Callahan - Collaborator - University of North Carolina at Chapel Hill
Liyuan Ma - Collaborator - GSK
Rachel E. Williams - Collaborator - GSKOutcomes:
Rheumatoid arthritis incidence; Rheumatoid arthritis severity at diagnosis.
Description: Technical Summary
This study will describe the demographics, comorbidities, diagnostic tests, rheumatoid arthritis symptoms, healthcare utilization, and prescription treatments for English rheumatoid arthritis (RA) patients in the three years prior to RA diagnosis to assess variables associated with incident RA diagnosis and high-severity RA at diagnosis. This information may identify potential early predictors of RA or patients more likely to be diagnosed with high severity.
This study will also develop a statistical model of factors associated with high RA severity at the time of diagnosis. We will compare both LASSO regression and elastic net regularization models. This information may assist clinicians in improving clinical management and targeted therapeutic strategies for RA patients who present with high disease severity. It may also lead to early detection of RA in patients who would otherwise be diagnosed in a more severe state. RA patients identified and properly treated in the less-severe disease stages have the greatest chance of avoiding irreversible joint damage and achieving long-term remission.
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Completion of Recommended Hepatitis Vaccination Schedules Among Adults in the United Kingdom — Kelly Johnson ...
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Completion of Recommended Hepatitis Vaccination Schedules Among Adults in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-06
Organisations:
Kelly Johnson - Chief Investigator - Merck & Co., Inc.
Kelly Johnson - Corresponding Applicant - Merck & Co., Inc.
Dongmu Zhang - Collaborator - AbbVie Inc. USA (Headquarters)Outcomes:
Compliance with the recommended timing of doses for hepatitis A, B and A/B vaccines; Completion of the recommended number of doses for hepatitis A, A/B, and B vaccines.
Description: Technical Summary
The primary objective of the study is to estimate hepatitis A and B dose completion and adherence with the two- and three-dose schedules in an adult insured population in the UK. This is a retrospective database study using anonymised primary care electronic health record (EHR) data from January 1, 2009, through December 31, 2016. This study will use the Clinical Practice Research Datalink (CPRD). Health records from January 1, 2009, through December 31, 2016, will be used. The primary outcomes from this study are completion of 2 and 3 doses of hepatitis A and B vaccine over various time periods and adherence with the 2- and 3-dose recommended schedules. All analyses are exploratory. Median time to completion and the proportion of patients who completed 2 and 3 doses and complied with the recommended schedule within specific time periods of the first dose will be estimated using Kaplan-Meier survival curves.
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Real-World Evidence in Oncology in England: Epidemiology, Patient Characteristics and Survival — Sreeram Ramagopalan ...
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Real-World Evidence in Oncology in England: Epidemiology, Patient Characteristics and Survival
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-23
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Sreeram Ramagopalan - Corresponding Applicant - London School Of Economics & Political Science
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )Outcomes:
Outcomes:
- Overall survival (OS): defined as time since index date or initiation of chemotherapy until date of death due to any cause identified from ONS data.
- Incidence rates of cancers: Number of new cases of a specific cancer in the population in 2012, 2013, 2014, and 2015 expressed as number of cancers per 100,000 population at risk.
- Incident cancer events will be identified from the CPRD-Cancer registry databases as the first record for a cancer indication of interest in either of these databases. Diagnoses must be present in both databases.Description: Technical Summary
According to Cancer Research UK, there were around 357,000 new cases of cancer in the United Kingdom (UK) in 2014, however there is limited recent real-world data on cancer patients in the UK. The rationale of this study therefore is to fill this evidence gap and describe the characteristics and overall survival of patients with a number of cancers in England. Specifically, the aims are to understand patient characteristics (demographic and clinical) and survival rates. In order to do this, the study will link data from the Clinical Practice Research Datalink, Hospital Episodes Statistics, National Cancer Registration and Analysis Service and Office of National Statistics (ONS) in order to provide the most accurate data on patient diagnoses and clinical characteristics.
Patient demographics, baseline clinical characteristics and tumour status will be analysed descriptively. Overall survival (OS) will be summarized as a continuous variable, Kaplan-Meier curves presented and median time estimated. Death rates will be described separately for those with and without advanced/metastatic cancer.
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Comparative effectiveness of initial bronchodilator therapies in COPD — Samy Suissa ...
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Comparative effectiveness of initial bronchodilator therapies in COPD
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-16
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Enrico Ripamonti - Collaborator - Milan Center for Neuroscience
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
The primary outcome event is the first moderate or severe COPD exacerbation to occur after cohort entry. A moderate exacerbation will be defined by a new prescription for prednisolone and a severe exacerbation by a hospitalisation for COPD (ICD-10 codes: J41, J42, J43, J44). The first secondary outcome is the rate of COPD exacerbations over the one-year follow-up. This outcome will be based on the number of courses of treatment with prednisolone and hospitalisations. A gap of at least 30 days between treatment courses will be required to consider the exacerbations as separate events. The second secondary outcome is the occurrence of the first community-acquired pneumonia and will be defined using the following codes: J10.0; J11.0; J12-J18; J22; J69; J85.0; J85.1; J86. This definition has been used successfully in COPD
Description: Technical Summary
The objective of this study is to assess the effectiveness and safety of the initial long-acting bronchodilator treatment of chronic obstructive pulmonary disease (COPD). In particular, long-acting muscarinic antagonists (LAMA) will be compared with long-acting beta2-agonists (LABA) combined with an inhaled corticosteroid (ICS) in a single inhaler (LABA-ICS), since the majority of LABAs used in practice are prescribed in such a combined inhaler. We will conduct a cohort study among patients with COPD to assess the effect of treatment initiation with a LAMA compared with LABA-ICS (single inhaler) on the time to a COPD exacerbation and on the risk of pneumonia. Each patient initiating treatment with a LAMA will be time-matched to a LABA-ICS initiator on high-dimensional propensity score, sex, and the presence of a prior acute COPD exacerbation in the year before cohort entry. Subjects will be followed for up to one year or until the occurrence of the outcome. The time-dependent Cox proportional hazard model will be used to perform an as-treated analysis to estimate the effect of current use of LABA-ICS versus LAMA on the risk of a first COPD exacerbation and pneumonia, stratifying by blood eosinophil levels, a recently identified potential biomarker of ICS response.
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Identification of patterns of symptoms and comorbidities presented to primary care prior to diagnosis of first episode psychosis: an electronic health record study — Ying Chen ...
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Identification of patterns of symptoms and comorbidities presented to primary care prior to diagnosis of first episode psychosis: an electronic health record study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-22
Organisations:
Ying Chen - Chief Investigator - Keele University
Ying Chen - Corresponding Applicant - Keele University
Athula Sumathipala - Collaborator - Keele University
Carolyn Chew-Graham - Collaborator - Keele University
David Shiers - Collaborator - University of York
John Edwards - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Saeed Farooq - Collaborator - Keele UniversityOutcomes:
The specific objectives are, in patients newly diagnosed with psychosis, to determine:
1. The prevalence and duration of prior consultation in primary care for symptoms related to FEP;
2. The extent of pre-existing chronic comorbidity;
3. Common patterns of symptoms and comorbidities presented prior to diagnosis.Description: Technical Summary
Long duration of untreated psychosis (DUP), the period between onset of psychotic symptoms and treatment, is associated with poor outcomes. Initiatives to shorten DUP have largely been unsuccessful. Identification of the patterns and nature of symptoms in the prodromal period prior to the diagnosis may help to identify patients earlier thus helping to reduce DUP.
The objectives are to determine, in patients with first episode psychosis (FEP): (i) prevalence and duration of prior consultation in primary care for symptoms related to FEP, (ii) common patterns of symptoms presented prior to diagnosis, and (iii) extent of pre-existing chronic comorbidity. This is a case-control study comparing prior patterns and duration of symptoms and chronic comorbidity in approximately 12,000 patients with FEP to 48,000 controls.
We will use conditional logistic regression to compare prevalence of each symptom and comorbidity between cases and controls. In cases, we will determine the median (interquartile range) duration of DUP, the interval between first consultation for a potential psychotic symptom and date of prescription of antipsychotics lasting for more than a month. We also will use latent class analysis to determine common patterns of symptoms presented to primary care before diagnosis in cases.
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Incidence of Type II Diabetes in Chronic Obstructive Pulmonary Disease — Alicia Gayle ...
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Incidence of Type II Diabetes in Chronic Obstructive Pulmonary Disease
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-01
Organisations:
Alicia Gayle - Chief Investigator - Imperial College London
Alicia Gayle - Corresponding Applicant - Imperial College London
Chris D Poole - Collaborator - Digital Health Labs Limited
Clare Bolton - Collaborator - Boehringer-Ingelheim - UK
Jennifer Quint - Collaborator - Imperial College London
Scott Dickinson - Collaborator - Boehringer-Ingelheim - UKOutcomes:
COPD Exacerbation Status
- Association between incident diabetes and exacerbation statusDescription: Technical Summary
Clinical trials investigating drugs used as maintenance therapy for Chronic obstructive pulmonary disease (COPD) do not usually target onset diabetes as a primary outcome and therefore there is a need to directly re-examine whether this association holds in a contemporary cohort of COPD patients. The Objective of this study is to investigate the risk factors associated with developing Type II Diabetes (DM) among patients with COPD. A cohort of COPD patients with incident DM will be 1:5 matched to patients without DM. Risk factors will be measured as logistic regression will be used to determine which risk factors are associated with incidence of DM. Patients classified as frequent exacerbators will be identified and the associations will be investigated.
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Chronic kidney disease stage G3-G5 and the risk of subsequent fractures after hip fracture — Frank de Vries ...
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Chronic kidney disease stage G3-G5 and the risk of subsequent fractures after hip fracture
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-08
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Caroline Wyers - Collaborator - Maastricht University
Irma de Bruin - Collaborator - Maastricht University
Johanna Driessen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Patrick Souverein - Collaborator - Utrecht University
Piet Geusens - Collaborator - Maastricht University
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Risk of fracture; Risk of subsequent fracture.
Description: Technical Summary
The Kidney Disease: Improving Global Outcomes (KDIGO) classification for chronic kidney disease (CKD) consists of 5 stages; G1: estimated glomerular filtration rate (eGFR) > 90ml/min/1.73m2, G2: eGFR 60-89 ml/min/1.73m2, G3: eGFR 30-59 ml/min/1.73m2, G4: eGFR 15 -29 ml/min/1.73m2 and G5: eGFR < 15ml/min/1.73m2.(1) This study`s objective is to evaluate the association between CKD stage G3-G5 and subsequent fragility fracture risk after a first hip fracture. Patients with a first hip fracture and CKD stage G1 and G2 will be the reference group. Within the CPRD, all patients aged 50 years or older with a first hip fracture will be selected. Kidney function will be assessed time-dependently and Cox regression models will be used to estimate the Hazard Ratio of the association between kidney function and subsequent fracture risk. Analyses will be adjusted for lifestyle variables, comorbidities and concomitant drug use.
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Developing tools for preventing delirium in primary care — David Melzer ...
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Developing tools for preventing delirium in primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-28
Organisations:
David Melzer - Chief Investigator - University of Exeter
Joao Delgado - Collaborator - University of Exeter
Joe Butchart - Collaborator - University of Exeter
Jose M Valderas - Collaborator - University of Exeter
Kirsty Bowman - Collaborator - University of Exeter
Lindsay Jones - Collaborator - University of Exeter
Rodney Stephen Taylor - Collaborator - University of Exeter
Ruben Mujica Mota - Collaborator - University of ExeterOutcomes:
Incident delirium
- All-cause mortality
- Health-care use (hospitalisations and length of stay, GP visits, medication, tests)Description: Technical Summary
Delirium often develops following potentially avoidable triggers, especially in patients with cognitive impairments. Risk factors in hospital settings are well studied and evidence suggests that interventions can reduce delirium incidence by up to 35% in hospital settings. In contrast, avoidable factors in community acquired delirium have been little studied. Electronic clinical records, such as the NIHR part-funded Clinical Practice Research Database (CPRD) provide cost-efficient opportunities for studying delirium in the community. We will develop a tool to help general practices identify patients at higher risk of delirium. A case-control analysis, using conditional logistic regression, will identify factors associated with delirium. Prediction models will be trained on the dataset ending in 2014, and validated on more recent (2015 onward) data, using established prediction performance measures. These prediction tools will also help to target information for carers about how to cope if an episode of delirium does develop. The tools will aim to identify those at higher risk of first episodes of delirium, and also those who have had previous episodes. This work is supported by NIHR Research for Patient Benefit project funding (PB-PG-1215-20022).
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Risk of Serious Infections in Patients with Psoriasis: a Cohort Study using the Clinical Practice Research Datalink — Darren Ashcroft ...
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Risk of Serious Infections in Patients with Psoriasis: a Cohort Study using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-13
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Zenas Yiu - Corresponding Applicant - University of Manchester
Christopher Griffiths - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of Manchester
richard warren - Collaborator - University of Manchester
Rosa Parisi - Collaborator - University of ManchesterOutcomes:
The main outcomes of the study will be: 1. incidence of first hospitalisation due to infection (including the subcategories of respiratory infections; skin and soft tissue infections; and urinary tract infections); 2. Death due to infection. We will examine death and hospitalisation reasons according to the International Code of Diseases version 10 (ICD-10) code lists.
Description: Technical Summary
Our aim is to investigate whether patients with psoriasis are at an increased risk of hospitalisation due to infection, death due to infection and at a decreased risk of hospitalisation due to cellulitis. A matched cohort study will be used. Adult patients identified using a Read coded diagnosis of psoriasis between 01/04/2003 and 31/12/2016, and eligible for linkage to outpatient and inpatient HES and ONS records will be matched (on age, gender and practice) with 6 unaffected comparison patients. Selection will be restricted to patients registered with a contributing practice for at least one year and follow-up will end when the patient either dies, transfers out of the practice, last data collection, the end of the study period, or experiences the outcome of interest. The outcome of first hospitalisation due to infection; and infection-related mortality will be defined according to ICD-10 classifications. Cox regressions will be used to investigate whether patients with psoriasis have a higher risk of hospitalisation due to any infection or due to cellulitis specifically. Hazard ratios (HRs) will be generated with and without adjustment for potential confounders. Adjustment will be made for patient-level deprivation, body mass index, presence of co-morbidities including diabetes, COPD/Asthma, HIV/AIDS, alcohol intake, Charlson Comorbidity 7Index and smoking status. Missing data will be accounted for using multiple imputation.
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Longitudinal trends in continuity of care in English general practice — Anas El Turabi ...
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Longitudinal trends in continuity of care in English general practice
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-28
Organisations:
Anas El Turabi - Chief Investigator - University of Cambridge
Martin Roland - Collaborator - University of CambridgeOutcomes: none known
Description: Technical Summary
This study is a longitudinal study of trends in continuity of care in English general practice. It aims to quantify how levels of interpersonal continuity of care between GPs and patients have changed over a decade and the extent that such changes can be explained by changes in patient population characteristics. It also aims to identify whether trends differ substantially: a) for patients of different characteristics (over/under 75 years and with/without multiple morbidities); and b) between practices.
Consultation data from a two-stage cluster random sample of patients in practices will be analysed using multilevel regression models to explore changes in three measures of continuity of care. Variance in continuity of care slopes between practices will be compared to within patient level variation as a way of interpreting the scale of between practice variance. Results will help identify whether practice-level variation in case-mix adjusted continuity rates exist, suggesting the possibility of practice-modifiable effects that may be the target for further research and policy action.
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Aripiprazole and risk of psychiatric treatment failure — Samy Suissa ...
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Aripiprazole and risk of psychiatric treatment failure
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-05
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Francois Montastruc - Collaborator - University Of Toulouse
Joelle MICALLEF - Collaborator - Service Hospitalo-Universitaire de Pharmacologie Clinique
Rui Nie - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
First psychiatric treatment failure defined as a composite of hospitalisation for a psychiatric event, non-fatal self-harm, or suicide within 365 days after antipsychotic treatment switching or add-on; Psychiatric admission using the following ICD-10 codes: organic disorders (F05-F07, F09), substance misuse (F10-F19), schizophrenia and related psychoses (F20-F29), mood disorders (F30-F39), anxiety disorders (F40-F48), eating disorders (F50), behavioral syndromes (F51-F59), disorders of adult personality (F60-F69) and unspecified diagnosis (F99). Fatal and non-fatal self-harm will be measured by death from suicide using ONS mortality database and by hospitalisation for self-harm in the HES database; The following ICD10-codes: intentional self-harm (X60-X84 and event of undetermined intent (Y10-Y34); Psychiatric treatment failure on the basis of Read codes in the CPRD to measure fatal and non-fatal self-harm.
Description: Technical Summary
Since the introduction in 2005 of aripiprazole, a D2 dopamine partial agonist prescribed to manage schizophrenia or bipolar disorder, several cases of abrupt psychotic worsening have been reported. These psychiatric decompensations seem to occur in two clinical situations: in patients previously treated with an antipsychotic who switched to aripiprazole, or in whom aripiprazole is added to another antipsychotic. Therefore, the primary objective of this study will be to compare the incidence rate of psychiatric treatment failure (defined as a composite of hospitalization for a psychiatric event, non-fatal self-harm, or suicide) among a base cohort of antipsychotic users who switch to or add aripiprazole (new users of aripiprazole) relative to those who switch to or add another antipsychotic. This study will be conducted by linking the CPRD, the HES inpatient database, and the ONS (Office for National Statistics) mortality database between January 1, 2000 and March 31, 2016. For each patient who initiates aripiprazole, we will have one high dimensional propensity score (hdPS)-matched patient starting another antipsychotic at the time the patient start aripiprazole, using a prevalent new-user design. Patients will be followed for 1 year for the occurrence of psychiatric treatment failure.
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Is patient-level achievement of primary care diabetes standards associated with emergency hospital admissions, mortality, non-traumatic amputation and/or diabetic retinopathy among the population with type 2 diabetes? A national observational study — Azeem Majeed ...
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Is patient-level achievement of primary care diabetes standards associated with emergency hospital admissions, mortality, non-traumatic amputation and/or diabetic retinopathy among the population with type 2 diabetes? A national observational study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-14
Organisations:
Azeem Majeed - Chief Investigator - Imperial College London
Ailsa McKay - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Eszter P Vamos - Collaborator - Imperial College London
Laura Gunn - Collaborator - Imperial College London
Manjula Nugawela - Collaborator - University College London ( UCL )
Pasha Normahani - Collaborator - Imperial College London
Sathish Thirunavukkarasu - Collaborator - McMaster University
Sobha Sivaprasad - Collaborator - University College London ( UCL )Outcomes:
Diabetes-related emergency hospital admission
- Diabetes-related mortality
- Cardiovascular disease-related emergency hospital admission
- Cardiovascular mortality
- Any emergency hospital admission
- All-cause mortalityDescription: Technical Summary
Objective: To determine whether achievement of primary care diabetes targets is associated with improved emergency hospital admission or mortality outcomes for people with type 2 diabetes, accounting for potential confounding by sociodemographic indices and baseline comorbidity, and potential interactions with age, duration of disease, and presence/absence of complications.
Methods: Historical closed cohort study. Participants >18 years with record of a type 2 diabetes diagnosis before April 2010 will be eligible for inclusion. Exposure status will be based on individual-level achievement of diabetes Quality and Outcomes Framework clinical targets and National Diabetes Audit care process measures, in the 2010-2011 year. Outcomes (diabetes-related, cardiovascular, and all-cause emergency hospital admissions and mortality) will be observed over the 2011-2016 period.
Data analysis: We will describe baseline characteristics, for those with each exposure status, among the full cohort. Applying propensity score matching to account for patient characteristics, we will use Poisson regression analyses to estimate the rate ratios denoting the differential incidence of hospital admissions, among the exposed versus unexposed groups, for each admission outcome. We will use Cox proportional hazards models to estimate survival, and the hazard ratios denoting the differential hazard of each mortality outcome, among the exposed versus unexposed groups.
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Epidemiology of von Willebrand Disease in the UK (1989-2016): Prevalence, treatment patterns, descriptive characteristics, and incidence and prevalence of various outcomes and co-morbidities based on routine clinical care. — Susan Jick ...
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Epidemiology of von Willebrand Disease in the UK (1989-2016): Prevalence, treatment patterns, descriptive characteristics, and incidence and prevalence of various outcomes and co-morbidities based on routine clinical care.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-02-13
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Von Willebrand Disease; Depression; Gynaecological invasive procedures; Cardiovascular disease; Anaemia; Heavy Menstrual Bleeding; Anxiety; Pregnancy complications; Gastrointestinal and Joint bleeds.
Description: Technical Summary
Using data from the CPRD GOLD we will identify patients who were diagnosed with von Willebrand disease. We will send GP questionnaires for a sample of patients with von Willebrand disease to confirm the diagnosis and obtain information on treatments that are not captured in the data, such as infusions and factor replacement. We will match up to 10 patients without von Willebrand disease to each patient with von Willebrand disease on age, sex, GP attended, registration year, and index date (date of von Willebrand diagnosis in matched patient with von Willebrand disease). We will use data from HES to supplement the data in the CPRD GOLD to add details on treatments and identify outcomes of interest. We will describe basic characteristics of patients with and without von Willebrand disease and estimate the risk (cumulative hazard function) of each study outcome at various times of follow-up. We will follow each patient from birth to the first of the following (censor date): 1) study outcome occurs (separately for each outcome), 2) end of data collection, or 3) death. We will estimate cumulative incidence rates with 95% CI of each of the study outcomes (assessed separately), stratified by severity of von Willebrand disease, age at von Willebrand diagnosis, and age at first von Willebrand treatment.
Source
2018 - 01
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Antipsychotic prescribing and subsequent risk of fractures and death in people aged 80 years and over: A cohort study using electronic health records. — Rafael Gafoor ...
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Antipsychotic prescribing and subsequent risk of fractures and death in people aged 80 years and over: A cohort study using electronic health records.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-24
Organisations:
Rafael Gafoor - Chief Investigator - King's College London (KCL)
Rafael Gafoor - Corresponding Applicant - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes: none known
Description: Technical Summary
Fractures are a serious cause of mortality and morbidity in those over 80 years old and there is interest in identifying ameliorable predictors.
We aim to determine whether use of antipsychotics may be associated with elevated risk of a fall / fracture or death in this vulnerable cohort. A prospective cohort study will be conducted using electronic health records of adults 80 years of age and over for 2006 to 2017.We will evaluate relative rates of fractures and/or death (simultaneously adjusting for confounding variables and potential interactions) employing a variety of statistical methods (survival analysis with competing risks, poisson, logistic regression and hierarchical multilevel modelling) using CPRD data of all eligible participants over the time-period of a decade. Outcomes will be confirmed by analysis of linked data from Hospital Episode Statistics (HES) where available.
We will investigate changes in these outcomes pre and post guidance in 2009 that recommended cessation of the use of atypical antipsychotics in those over 80 years old. We will stratify these analyses by presence/absence of dementia category.
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Feasibility study to establish the value of linked CPRD and HES data to support medical device vigilance — Katherine Donegan ...
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Feasibility study to establish the value of linked CPRD and HES data to support medical device vigilance
Datasets:GP data, HES Admitted Patient Care; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-24
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Craig Allen - Corresponding Applicant - MHRAOutcomes:
Primary:
- Immediate postoperative complications within the index admission record (measured in HES)
- Late postoperative complications within a subsequent admission to the index admission (measured in HES)
- Further surgical procedures related to incontinence or prolapse subsequent to the index admission (measured in HES)Secondary
- Incidence of uterine, vaginal bleeding and discharge symptoms recorded in primary care (measured in CPRD)
- Incidence of urinary tract infections recorded in primary care (measured in CPRD)
- Incidence of blood in urine recorded in primary care (measured in CPRD)
- Incidence of pain (abdominal, pelvic, leg, buttock, lower back, chronic pain) recorded in primary care (measured in CPRD)Description: Technical Summary
The aim of this study is to assess the value of linked CPRD data to support the MHRA's medical devices vigilance by exploring adverse events in women who had surgery for a mesh or non-mesh procedure to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP) as a case study. This descriptive exploratory retrospective cohort study will be conducted in the HES admitted patient care data for England utilising the linkage to primary care data. Two cohorts of women aged 18 years and above who had a first surgery for SUI or POP, with a mesh or non-mesh procedure, between April 2002-March 2016 will be derived. Adverse event incidence rates will be estimated, stratified by procedure type (mesh vs. non-mesh), and the pattern of potential symptoms emerging prior to mesh removal explored. Patient characteristics will be described according to age-group, BMI, recent childbirth (within 1 year of the index date - the first SUI or POP procedure), year and surgical speciality of the consultant performing the procedure. A decision on the continuation of the study will be made using an iterative approach, the first step determining whether our data are consistent with the respect to the study aims and the trends observed published recently using NHS Digital English national HES data.
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Antidepressant use during pregnancy: assessing benefits to mothers and long-term neurodevelopmental risks to children — Dheeraj Rai ...
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Antidepressant use during pregnancy: assessing benefits to mothers and long-term neurodevelopmental risks to children
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-22
Organisations:
Dheeraj Rai - Chief Investigator - University of Bristol
Hein Heuvelman - Corresponding Applicant - University of Bristol
Alan Emond - Collaborator - University of Bristol
David Gunnell - Collaborator - University of Bristol
Jonathan Evans - Collaborator - University of Bristol
Neil Davies - Collaborator - University of Bristol
Rachel Liebling - Collaborator - University Hospitals Bristol NHS Trust
Richard Morris - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Bristol
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes: none known
Description: Technical Summary
Observational intergenerational cohort study using the Clinical Practice Research Datalink (CPRD) linked to the Hospital Episodes Statistics and ONS death records using regression methods, propensity score matching, instrumental variable analysis, negative controls, and exposure discordant sibling control design.
Setting: Representative sample of UK General practice patients
Target population: Pregnant women with depression or prescribed antidepressants up to 1 year
before or during pregnancy
Inclusion Criteria: Women in the CPRD pregnancy register, who were registered with the
same CPRD Practice for at least 1 year before pregnancy and throughout the pregnancy period, who have a history of depression or antidepressant prescriptions recorded up to 1 year before or during pregnancy. A sub-cohort will include the mother-child pairs identified using CPRDÂs mother-baby link for whom follow-up data is available until the child is at least 4 years old.
Health technologies being assessed: Benefits and risks of starting antidepressants vs no drug
treatment for depression during pregnancy; continuing antidepressants vs stopping antidepressants during pregnancy.
Outcomes: Maternal: number of GP consultations,consultations and referrals for mental health problems, self harm, inpatient admission. Child:diagnosis of autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disability.
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Comparison of methodologies for establishing NHS Health Check pre-screening strategies using existing electronic health records — Angela Wood ...
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Comparison of methodologies for establishing NHS Health Check pre-screening strategies using existing electronic health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-24
Organisations:
Angela Wood - Chief Investigator - University of Cambridge
Angela Wood - Corresponding Applicant - University of Cambridge
Alexis Bellot - Collaborator - University of Cambridge
Amine M'Charrack - Collaborator - University of Cambridge
Daniel Jarrett - Collaborator - University of Cambridge
Danyang Yin - Collaborator - University of Cambridge
David Stevens - Collaborator - University of Cambridge
Ellie Paige - Collaborator - The Australian National University
Eoin McKinney - Collaborator - University of Cambridge
Francesca Gasperoni - Collaborator - Medical Research Council - MRC
Jessica Barrett - Collaborator - University of Cambridge
Jiaying Yao - Collaborator - University of Cambridge
Juliet Usher-Smith - Collaborator - University of Cambridge
Kamile Stankeviciute - Collaborator - University of Cambridge
Luanluan Sun - Collaborator - University of Cambridge
Michael Sweeting - Collaborator - University of Leicester
Mihaela van der Schaar - Collaborator - University of Oxford
Robson Machado - Collaborator - University of Cambridge
Ryan Chung - Collaborator - University of Cambridge
Stephen Kaptoge - Collaborator - University of Cambridge
Zhaozhi Qian - Collaborator - University of Cambridge
Zhe Xu - Collaborator - University of Cambridge
Outcomes: Cardiovascular disease (Ischaemic heart disease and stroke) - Chronic kidney disease
- Atrial fibrillation
- Type 2 diabetes
- DementiaDescription: Lay Summary
The NHS Health Check programme is one of the largest disease prevention initiatives in England. It was introduced in 2009 to help prevent heart attacks and strokes. A Health Check provides people with information about their risk of having a heart attack or stroke and offers lifestyle advice, referral and/or medication as needed. It now covers risks of other conditions like diabetes, kidney disease and dementia and includes looking for atrial fibrillation (an irregular heart rate). Many of the recommended lifestyle changes lower the risk of other diseases, such as cancer and lung disease.
Technical Summary
People aged between 40-75 years, who have not had a stroke and do not already have heart disease, diabetes or kidney disease are invited for an NHS health check every five years. However, it has been recommended to prioritise initial and repeat invitations to people with the greatest health need. Furthermore, it may be more cost-effective to target the repeat programme to people with higher risks of future disease and have longer time-intervals between invitations for those with lower risks of future disease.
We aim to develop methods which use existing electronic heath records to help identify people with greatest health needs for prioritisation for the NHS health check. We will use measurements of "risk factors" that are known to be linked with greater risk of disease (eg, older age, being male, smoking, high blood pressure, high cholesterol, above healthy weight) recorded at repeat general practice visits to estimate how likely someone is to develop future diseases and to also estimate when the person should next be invited for an NHS health check.It has been recommended to prioritise the NHS Health Check programme to people with the greatest health need, although there is no guidance on how this should be achieved. The benefits of using existing electronic health records for disease risk pre-screening and personalized heath care decisions is becoming increasingly recognized. We aim to develop methods which use existing electronic heath records to (i) identify people with greatest health needs for prioritisation for the NHS health check and (ii) estimate when a person should next be invited for an NHS health check.
We will develop a computationally feasible approach to handle the methodological challenges in utilizing historical repeat measures of multiple risk factors recorded in electronic health records to systematically identify patients at high risk of multiple future diseases. The models will incorporate use of multivariate repeat risk factors, measurement errors, missing data, competing risks, dynamic risk prediction, time-to-event data, and internal validation techniques (eg, cross validation).
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Morbidity and mortality of UK smokers relative to non-smokers: cohort analysis — Jennifer Quint ...
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Morbidity and mortality of UK smokers relative to non-smokers: cohort analysis
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-23
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Ann Morgan - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
Smoking causes significant morbidity and mortality. In this cohort study we will use Cox regression to compare a group of smokers (current and ex) to never smokers and investigate differences in the incidence of certain cancers (lung, oropharynx, larynx, oesophagus, acute myeloid leukaemia, stomach, liver, pancreas, kidney and ureter, bladder, cervix and colorectal) as well as other diseases (ischaemic heart disease, stroke, abdominal aortic aneurysm, pneumonia, COPD, and diabetes) to try and ascertain how smoking may impact on morbidity and mortality. This information will feed into the smoking report currently being commissioned by the Royal College of Physicians. We are aware that this cohort study is not all encompassing but instead we have chosen a number of representative diseases to study.
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Cardiovascular and cerebrovascular safety of testosterone replacement therapy in hypogonadal men — Samy Suissa ...
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Cardiovascular and cerebrovascular safety of testosterone replacement therapy in hypogonadal men
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-17
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Laurent Azoulay - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Rui Nie - Collaborator - McGill University
Simone Loo - Collaborator - McGill UniversityOutcomes:
Ischemic stroke; Myocardial infarction; All-cause mortality.
Description: Technical Summary
It is unclear whether testosterone replacement therapy (TRT) increases the risk of cardiovascular and cerebrovascular events. Therefore, the objective of our study is to evaluate the safety of TRT, specifically with respect to myocardial infarction and ischemic stroke, as well as all-cause mortality. We will create a cohort of men aged 45 or older, diagnosed with hypogonadism, and with no history of TRT use prior to diagnosis. In primary analyses, exposure to TRT will be defined as a time-dependent variable, and Cox regression will be used to evaluate the rates of myocardial infarction, ischemic stroke, and all-cause mortality, comparing current TRT exposure to no exposure. These outcomes will be evaluated both as a composite outcome, and separately. In secondary analyses, we will assess whether this risk varies with cumulative duration of TRT use (< 6 months, 6 months - 2 years, > 2 years). The primary analyses will be repeated, with stratification on TRT formulation, as well as patient age (45-59, 60-74, and 75 years and older), history of myocardial infarction, history of ischemic stroke, diabetes, and chronic kidney disease status. Finally, we will use marginal structural Cox models to evaluate the safety of TRT while accounting for time-dependent covariates.
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Determining health outcomes and resource utilisation associated with hyperkalemia in the UK. — Mireia Raluy Callado ...
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Determining health outcomes and resource utilisation associated with hyperkalemia in the UK.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-15
Organisations:
Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Alex Simpson - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Annalisa Rubino - Collaborator - Evidera, Inc
Rikisha Gupta Shah - Collaborator - Evidera, Inc
Vrouchou Panagiota - Collaborator - Vifor PharmaOutcomes: none known
Description: Technical Summary
Patients diagnosed with CKD and /or heart failure are at high risk of developing hyperkalemia due to the fact that the glomerular filtration rate of their kidneys is too low to sufficiently remove excess potassium. This risk is compounded by medications they may be prescribed to treat their conditions- Renin-Angiotensin-Aldosterone System inhibitors (RAASi). A major side effect of RAASI therapy is the inhibition of potassium excretion in the kidneys. Thus, patients with CKD and/or heart failure who are being treated with RAASi are at an enhanced risk of developing hyperkalemia. There is a need in this patient population for a treatment that lets these patients to continue on RAASi therapy without the risk of developing hyperkalemia through excess potassium retention.
The purpose of this study is to estimate health outcomes and resource utilisation of patients with CKD and/or heart failure who experience hyperkalemia. To this aim, we will quantify healthcare resource use (number of doctor visits, hospitalisations medical tests, procedures and prescriptions) throughout the observation period. Furthermore, we will compute the numbers and percentages of patients who experienced clinical outcomes of interest among those who were treated with RAASi prior to developing hyperkalemia. Together, these results will help inform which patient groups are most in need of an effective hyperkalemia treatment.
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The risk of angioedema and other specific safety events of interest in association with use of sacubitril/valsartan in adult patients with heart failure - a cohort study — Christoph Meier ...
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The risk of angioedema and other specific safety events of interest in association with use of sacubitril/valsartan in adult patients with heart failure - a cohort study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-30
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Marlene Rauch - Corresponding Applicant - University of Basel
- Collaborator -
Josephina Kuiper - Collaborator - Pharmo Institute
Miriam Sturkenboom - Collaborator - University Medical Centre Utrecht
Raymond Schlienger - Collaborator - Novartis Pharma AG
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Angioedema; Hepatotoxicity; Hypotension; Renal impairment; Hyperkalemia.
Description: Technical Summary
Sacubitril/valsartan is a novel treatment for adult patients with symptomatic chronic heart failure. In the double-blind phase of a large pre-marketing trial, a higher proportion of patients randomized to sacubitril/valsartan had angioedema as compared to the angiotensin-converting enzyme inhibitor (ACEI) enalapril (0.45% vs. 0.24%). Also, hypotension was reported more often in sacubitril/valsartan users compared with enalapril users (17.6% vs. 11.9%). Hyperkalemia or serum potassium concentrations >5.4 mmol/l were reported slightly less often in sacubitril-valsartan users compared with enalapril users (11.6% and 19.7% vs. 14.0% and 21.1%, respectively). The risk of hepatotoxicity or renal impairment did not differ considerably between the two patient groups. Nevertheless, hyperkalemia, hepatotoxicity, and renal impairment are listed as potential or identified risks in the risk management plan of sacubitril/valsartan. Real-world data to quantify the above outlined adverse events associated with sacubitril/valsartan use and the relative risk of these in new users of sacubitril/valsartan compared with new users of ACEIs, are missing. This large post-authorization cohort study based on data from five European databases (including the Clinical Practice Research Datalink) will assess the risk of angioedema and other outlined adverse events in association with sacubitril/valsartan use versus ACEI use in adult patients with heart failure.
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Bendroflumethiazide versus Indapamide for Primary Hypertension: Observational (BISON) study within CPRD — Tatiana Macfarlane ...
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Bendroflumethiazide versus Indapamide for Primary Hypertension: Observational (BISON) study within CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-18
Organisations:
Tatiana Macfarlane - Chief Investigator - University of Dundee
Amy Rogers - Collaborator - University of Dundee
Daniel Morales - Collaborator - University of Dundee
Isla Mackenzie - Collaborator - University of Dundee
Rob Flynn - Collaborator - University of Dundee
Steve Morant - Collaborator - University of Dundee
Thomas MacDonald - Collaborator - University of DundeeOutcomes:
acute decompensated heart failure
- death from cardiovascular causes
- all-cause mortality
- treatment discontinuation, switch or intensification
- diabetes
- hospitalisation
- gout
- hyponatremia
- hypokalaemia
- hip fracture
- renal disease
- dementiaDescription: Technical Summary
This study aims to compare the effects of prescribing indapamide, a thiazide-like diuretic, with bendroflumethiazide, a thiazide diuretic, as the first-line choice of diuretic in the treatment of hypertension. The outcome measure will be a composite of non-fatal myocardial infarction, acute coronary syndrome, stroke, acute decompensated heart failure or death from cardiovascular causes. We will identify in CPRD all patients aged 18 years and over with first diagnosis of hypertension after 1987. Among them, we will form two groups with first ever prescription of indapamide or bendroflumethiazide. We will follow the groups either to the date of last prescription, date of medication switch, date of additional medication for hypertension (such as beta-blockers, calcium channel blockers, ACE inhibitors, alpha-blockers, ARBs or other antihypertensive medication), date of outcome, date of de-registration with the medical practice or the date of last practice data collection. We will also extract information on patient age, sex, medical practice, co-morbidities, co-prescribed medication, smoking, weight and alcohol consumption. Incidence of event rates will be calculated in each group. Descriptive analysis, and univariate and multivariate Cox regression survival models will be used as appropriate. Subgroup analyses will be implemented for known risk factors. This large population-based study may provide new evidence on the potential benefit of treating hypertensive patients with indapamide or bendroflumethiazide and may inform future clinical trials.
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Excess risk and predictors of fracture/s following bariatric surgery for obese patients in the NHS: a real-world self-controlled case series and cohort study — Daniel Prieto...
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Excess risk and predictors of fracture/s following bariatric surgery for obese patients in the NHS: a real-world self-controlled case series and cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-15
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Cyrus Cooper - Collaborator - University of Southampton
Danielle Robinson - Collaborator - University of Manchester
Garry TAN - Collaborator - Oxford University Hospitals
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kassim Javaid - Collaborator - University of Oxford
Sara Khalid - Collaborator - University of Oxford
Victoria Y Strauss - Collaborator - University of OxfordOutcomes:
Primary: Any osteoporotic fracture/s (any site except skull, face, or digits)
- Secondary1: major fracture (hip, wrist/forearm, spine, and proximal humerus)
- Secondary2: peripheral fracture/s (wrist/forearm, ankle, proximal humerus)Description: Technical Summary
OBJECTIVES
1. To use self-controlled case series (SCCS) to assess fracture risk before and after bariatric surgery.
2. To determine key predictors of post-operative fracture, and produce a fracture risk prediction tool.METHODS
- Data sources: CPRD linked to HES.
- Participants: patients in CPRD with a body mass index (BMI) of 35+ undergoing bariatric surgery. Patients with <1 year of data or with a gastrointestinal cancer before surgery will be excluded.
- Exposures:
Bariatric surgery will be identified using READ (CPRD) and OPCS4 (HES) codes.
Predictors of post-operative fracture/s, based on consensus and literature review: age, gender, systemic steroid use, BMI, fracture history, smoking, alcohol drinking, inflammatory arthritis, secondary osteoporosis, type 2 diabetes and related treatments, other drugs affecting fracture risk, socio-economic deprivation, and available blood tests.
- Outcomes:
Primary outcome will be any osteoporotic fracture/s (excluding skull, face, or digits) in the 5 years
following bariatric surgery
Secondary: 1.major fracture (hip, wrist/forearm, spine, and proximal humerus), 2.peripheral fracture/s (wrist-forearm, ankle, and proximal humerus).DATA ANALYSIS: Incidence rate ratios (IRR) will be calculated for fracture/s within the "exposure" (5 years
post-surgery) period compared to baseline (presurgery) using SCCS methods. A cohort design will be used to identify key predictors of 5-year postoperative fracture
Source - and 5 more projects — click to show
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Preterm birth and long-term risk of cardio-metabolic diseases — Pensee Wu ...
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Preterm birth and long-term risk of cardio-metabolic diseases
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-24
Organisations:
Pensee Wu - Chief Investigator - Keele University
Pensee Wu - Corresponding Applicant - Keele University
Carolyn Chew-Graham - Collaborator - Keele University
Claire Lawson - Collaborator - University of Leicester
Kelvin Jordan - Collaborator - Keele University
Mamas Mamas - Collaborator - Keele University
Umesh T Kadam - Collaborator - Keele UniversityOutcomes:
1) Coronary heart disease, defined as consultation for coronary heart disease, myocardial infarction, or coronary revascularization.
(2) Stroke, defined as consultation for stroke or transient ischaemic attack.
(3) Composite cardiovascular disease, defined as consultation for hypertension, coronary heart disease, myocardial infarction, coronary revascularization, heart failure, cardiomyopathy, stroke, transient ischaemic attack or peripheral vascular disease.
(4) Diabetes, defined as consultation for diabetes; prescription for antidiabetic antidiabetic (e.g. insulin, glibenclamide, metformin); and abnormal glucose tolerance test, fasting glucose or glycosylated haemoglobin.
(5) Mortality.Description: Technical Summary
Background
Some studies have linked preterm birth with future risks of cardiovascular disease and diabetes (cardio-metabolic diseases). However, it remains unclear whether preterm birth is an independent risk factor for future cardio-metabolic diseases or an early marker of women with high-risk factors for developing these diseases.Objective
To assess whether preterm birth is an independent risk factor for long-term cardio-metabolic diseases.Methods
Using a comparative cohort design, we will compare women with and without preterm birth (ÂexposureÂ), who had singleton pregnancies between 1997 and 2006. They will be followed for long-term cardio-metabolic diseases until incident event, end of 2016, last data collection or until they no longer contribute to CPRD due to leaving practice, death, or the practice leaving CPRD.Data analysis
The baseline cardio-metabolic risk factors will be compared between women with and without preterm birth, using Chi-squared tests for categorical variables and t-tests for continuous variables. The independent associations between preterm birth and long-term cardio-metabolic diseases will be investigated using Cox proportional hazards model, adjusting for other potential risk factors. We will then assess differences in strength of the association of other risk factors with cardio-metabolic diseases between women with preterm and term births using interaction terms.
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Partner bereavement and subsequent diagnosis of specific skin diseases — Sinead Langan ...
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Partner bereavement and subsequent diagnosis of specific skin diseases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-22
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Amy Mulick - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Henrik Toft Sorensen - Collaborator - Aarhus University
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sigrun Alba Johannesdottir Schmidt - Collaborator - Aarhus University Hospital
Yun "Angel" Wong - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Psoriasis
- Atopic eczema
- Vitiligo
- Melanoma risk and prognosis
- Alopecia areata
- UrticariaDescription: Technical Summary
We will use a matched cohort study to examine if bereavement is associated with the onset of psoriasis, atopic eczema, vitiligo, melanoma, alopecia areata or urticaria. Partners will be defined as two persons with (1) the same family number, (2) opposite sex, (3) an age gap of 10 years or less and (4) no younger adult in the household within 15 years of either of the couple. We will then identify all deaths occurring in the couples during 1997-2014 and the bereaved partner will be classified as bereaved/exposed. The date of bereavement will be considered the index date. Next, we will randomly match five persons to each exposed person by age, sex and general practice. Persons in the matched cohort have to be alive and have a partner but without ever experiencing previous partner bereavement on the index date for the matched exposed person. Using stratified Cox regression, we will compute hazard ratios with 95% confidence intervals for the association between bereavement and each outcome. We will examine if associations depend on risk of partner death (as measured by the age-adjusted Charlson Comorbidity Index) and time since bereavement. For melanoma, we will additionally assess if bereavement is associated with worsened prognosis.
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A study of pneumonia following self-limiting respiratory tract infections managed in primary care — Martin Gulliford ...
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A study of pneumonia following self-limiting respiratory tract infections managed in primary care
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-18
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Xiaohui Sun - Corresponding Applicant - King's College London (KCL)Outcomes: none known
Description: Technical Summary
The increasing challenge of antimicrobial resistance requires more judicious use of antibiotics. Primary care prescribers are encouraged to treat self-limiting respiratory tract infections (including colds, sore throat, otitis media, sinusitis and bronchitis) without antibiotics in order to curb their unnecessary use. This approach could be hazardous for some subgroups of patients that may be at higher risk of infectious complications, including pneumonia. Identification of risk factors contributing secondary pneumonia following self-limiting respiratory tract infection consultations will help to assist clinical decision making and disease management in primary care. In a nested case-control study, cases will be adult patients presenting with RTI in primary care who develop secondary pneumonia within 30 days, while controls will be patients with RTI who did not have pneumonia. A systematic review will be conducted to contribute to identifying candidate risk factors. Conditional logistic regression will be employed to adjust for confounding. We also aim to develop a clinical prediction model for pneumonia following self-limiting respiratory tract infection using a cohort of patients presenting with RTI. Analyses will follow good practice recommendations for prediction model development including assessment of model performance and validity. The study will provide improved understanding of risk factors for pneumonia following self-limiting RTI in adults
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Lifestyle and socio-economic risk factors for non-valvular atrial fibrillation — Alexander Cohen ...
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Lifestyle and socio-economic risk factors for non-valvular atrial fibrillation
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-17
Organisations:
Alexander Cohen - Chief Investigator - King's College London (KCL)
Alexander Cohen - Corresponding Applicant - King's College London (KCL)
Carlos Martinez - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Catalin Adrian Buzea - Collaborator - Carol Davila University of Medicine and Pharmacy
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Jeffrey Weitz - Collaborator - McMaster University
Leopoldo Pagliani - Collaborator - University of Padova
Mario Santos - Collaborator - Hospital Santo Antonio, Centro Hospitalar do Porto
Rui Providencia - Collaborator - St Bartholomew's Hospital
Tiago Gregorio - Collaborator - University of Porto Faculty of MedicineOutcomes:
Non-valvular atrial fibrillation.
Description: Technical Summary
Lifestyle related factors such as smoking, alcohol consumption and obesity affect the risk of developing cardiovascular diseases and other related conditions such as high blood pressure and atherosclerosis1-4. Socio-economic status is also related to many of these risks and to cardiovascular disease.
This study aims to investigate lifestyle and socio-economic risk factors for non-valvular atrial fibrillation (AF).
Therefore a population-based case-control study will be performed using patients with AF as cases and age- and gender matched patients without AF as controls.
The relationship between lifestyle/socio-economic factors and AF will be estimated using crude and adjusted odds ratios from conditional logistic regression models.
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Epidemiology study of Invasive Extra-Intestinal pathogenic Escherichia coli (ExPEC) Disease in adults and elderly using real world healthcare databases — Eva Herweijer ...
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Epidemiology study of Invasive Extra-Intestinal pathogenic Escherichia coli (ExPEC) Disease in adults and elderly using real world healthcare databases
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2018-01-24
Organisations:
Eva Herweijer - Chief Investigator - Ingress-health
Eva Herweijer - Corresponding Applicant - Ingress-health
Alan Johnson - Collaborator - Public Health England
Germano Ferreira - Collaborator - Not from an Organisation
Kaatje Bollaerts - Collaborator - P95
Russell Hope - Collaborator - Public Health England
Thomas Verstraeten - Collaborator - P95Outcomes:
IED (incidence rate); Death (crude mortality rate, case fatality rate).
Description: Technical Summary
Extra-intestinal pathogenic Escherichia coli (ExPEC) are the main cause of urinary tract infections (UTIs) and also commonly lead to other infections such as bloodstream infections, meningitis, and pneumonia. E. coli infections of sterile sites, referred to as Invasive ExPEC Disease (IED), is a notable public health problem. The objective of this primarily descriptive study is to generate evidence on IED epidemiology in adults, especially the elderly, from a high income country. We will conduct an observational, retrospective cohort study using health-records of the CPRD population eligible for linkage with HES Admitted Patient Care, ONS Death Registration Data, and HES Outpatient from 1st January 2000 to the latest CPRD release available at the time of analyses. We will estimate the frequency (incidence rate) of IED in the study population, as well as in specific sub-groups, defined by disease risk factors, such as demographic variables (e.g., age), chronic medical conditions (e.g., type 2 diabetes mellitus, chronic kidney disease), acute medical events (e.g., UTI), and medical interventions (e.g., indwelling urinary catheters, surgical procedures). We will also calculate the mortality rate related to IED and the proportion of cases who die during the study period.
Source
2017 - 12
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Risk of nephrotic syndrome among non-steroidal anti-inflammatory drug users: a population-based study in the United Kingdom — Olaf Klungel ...
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Risk of nephrotic syndrome among non-steroidal anti-inflammatory drug users: a population-based study in the United Kingdom
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-08
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Anthonius de Boer - Collaborator - Utrecht University
Mohammad Bakhriansyah - Collaborator - Utrecht UniversityOutcomes:
Nephrotic syndromes
Description: Technical Summary
We aim to evaluate the association between NSAIDs and the risk of NS by conducting a case-control study in CPRD. Cases will be patients with a first diagnosis of NS (index-date), while controls will be those without a diagnosis of NS prior to the index-date. Each case will be matched to up to 3 controls by age, sex, practice, and the index-date. Exposure of interest will be NSAID use directly prior or at the index-date. Patients who were not using any NSAIDs prior to the index-date will be categorized as nonusers. Potential confounders taken into account will be comorbidities, co-medications, body mass index (BMI), and lifestyle. The strength of the association between NSAID use and NS will be estimated using conditional logistic regression model with different adjustment models, i.e. 1) no adjustment, 2) adjusted for comorbidities that are known to be associated with NS, 3) additionally adjusted for other potential confounders associated with renal toxicity, and 4) additionally adjusted for BMI and lifestyle factors (full model). Duration of NSAID use in relation to NS will also be studied. Finally, we will assess potential effect modification by age, sex, diabetes mellitus (DM), and membranous glomerulonephritis.
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Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England — Robert Carroll ...
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Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-18
Organisations:
Robert Carroll - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Cormac Sammon - Corresponding Applicant - PHMR Associates
Elaine Stamp - Collaborator - PHMR Associates
Megan Besford - Collaborator - PHMR AssociatesOutcomes:
Major bleeding; Intracranial bleeding; Gastrointestinal bleeding; Clinically relevant non-major bleeding; Ischemic stroke; Ischemic stroke, unspecified stroke and systemic embolic events.
Description: Technical Summary
Novel Oral Anticoagulants (NOACs) have at least equivalent effectiveness and improved safety in comparison to Vitamin K antagonists (VKA) such as warfarin in the clinical trial setting. It is important to ensure that the safety of patients treated with anticoagulation is also reflected in the long-term in the real-world setting. The primary aim of this study is to investigate the risk of bleeding in NVAF patients newly prescribed NOACs in England. An exploratory objective will be to investigate the effectiveness of NOACs in stroke prevention. A further exploratory objective will be to assess whether differing approaches to estimating days of supply of warfarin impact our findings on its comparative safety and effectiveness. We will use a retrospective cohort study design including patients with non-valvular atrial fibrillation (NVAF) who are newly prescribed NOACs in routine clinical practice in England. This study will utilise data from the Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics. Propensity score matching will be used to create balanced treatment groups for pairwise comparisons, with warfarin serving as the reference group. Time from treatment to clinical events of interest will be summarised using Kaplan-Meier curves and modelled using Cox-regression analyses.
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Assessing the Burden of Illness of Generalised Refractory Myasthenia Gravis in England, using the CPRD database — Delphine Saragoussi ...
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Assessing the Burden of Illness of Generalised Refractory Myasthenia Gravis in England, using the CPRD database
Datasets:GP data, HES Accident and Emergency; HES Accident and Emergency; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-18
Organisations:
Delphine Saragoussi - Chief Investigator - Evidera, Inc
Brian Sanderson - Collaborator - PPD - UK
Gilbert L'Italien - Collaborator - Alexion Pharmaceuticals
Jacob Saiju - Collaborator - University Hospitals Birmingham
Jennifer Hynson - Collaborator - PPD North America
Sharon MacLachlan - Collaborator - Evidera, Inc
Sophie Graham - Collaborator - Evidera, IncOutcomes:
Myasthenic Crisis
- Exacerbation
- Treatment use
- Resource Utilisation - GP visits/nurse visits/home or telephone visit, hospital admissions, ER visits, hospital length of stayDescription: Technical Summary
MG is an autoimmune disorder of the neuromuscular junction caused by autoantibodies at the nicotinic acetylcholine (AChR) or muscle-specific tyrosine kinase (MuSK) receptors. Initially typical patients present with extraocular muscle weakness (ptosis or diplopia), and subsequently develop limb, bulbar, and/or muscle weakness (Generalised MG). Standard first-line treatment for MG involves acetylcholinesterase inhibitors or thymectomy followed by prednisolone, a corticosteroid. Patients whose symptoms do not sufficiently respond to these therapies are administered immunosuppressants (ISTs) and/or intravenous immunoglobulins (IVIg). Approximately 10-15% of patients cannot tolerate and/or do not respond to an escalating regimen involving ISTs/IVIg and continue to demonstrate symptoms; these patients are known as 'refractory', These patients experience severe and debilitating symptoms, including: slurred speech, difficulty chewing and swallowing, impaired vision, limb and respiratory weakness and even respiratory failure (myasthenic crises). Using real-world data from the UK Clinical Practice Research Datalink (CPRD), this study aims to identify patients with refractory generalised MG, and to assess their burden of illness, in clinical and humanistic terms, and their resource utilisation relative to patients with non-refractory MG and age- and gender-matched individuals without MG using CPRD and a patient questionnaire. This will help quantify the magnitude of unmet need for a therapy that can help this difficult-to-treat population.
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The risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan - a case-control study using data of the Clinical Practice Research Datalink — Christoph Meier ...
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The risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan - a case-control study using data of the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-15
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Marlene Rauch - Corresponding Applicant - University of Basel
- Collaborator -
Josephina Kuiper - Collaborator - Pharmo Institute
Miriam Sturkenboom - Collaborator - University Medical Centre Utrecht
Raymond Schlienger - Collaborator - Novartis Pharma AG
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Myotoxicity; Hepatotoxicity; Acute pancreatitis.
Description: Technical Summary
Sacubitril/valsartan is a novel treatment for adult patients with symptomatic chronic heart failure with reduced ejection fraction. Sacubitril inhibits organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3 transporters in vitro. Based on this finding, drug-drug interaction studies have been performed between sacubitril/valsartan and atorvastatin or simvastatin (substrates of these transporters). Sacubitril/valsartan increased the maximal plasma concentrations of atorvastatin and its metabolites by up to 2-fold, but did not increase the areas under the curve of atorvastatin and its metabolites. Sacubitril/valsartan had no clinically significant impact on exposures of simvastatin and its active metabolite. Given the high proportion of patients expected to be on a concomitant therapy with sacubitril/valsartan and statins, the market authorization holder of sacubitril/valsartan aims to further evaluate in the post-marketing setting this potential drug-drug interaction that may increase the risk of statin-associated myotoxicity, hepatotoxicity, or acute pancreatitis. This case-control study aims to assess the risk of myotoxicity, hepatotoxicity, and acute pancreatitis in association with concomitant use of statins and sacubitril/valsartan, compared with use of statins without sacubitril/valsartan, in adult patients with heart failure. It is part of a large, observational, multi-database post-authorization safety study using data retrieved from five different databases, including the Clinical Practice Research Datalink.
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Use of metformin add on to insulin among patients diagnosed Type 1 diabetes mellitus in UK — Celine Quelen ...
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Use of metformin add on to insulin among patients diagnosed Type 1 diabetes mellitus in UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-18
Organisations:
Celine Quelen - Chief Investigator - Creativ-Ceutical
Celine Quelen - Corresponding Applicant - Creativ-Ceutical
Una Rigney - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes:
Metformin use in Type 1 diabetes mellitus (only count).
Description: Technical Summary
Approximately 10% of patients suffering diabetes in England have Type 1 diabetes (TD1M), which is caused by damage to cells in the pancreas meaning the body is unable to produce sufficient insulin. This insulin lack results in high blood glucose levels which can lead to major health issues. T1DM is treated through continuous insulin therapy to maintain blood glucose levels. To improve blood glucose control in T1DM, National Institute for Care and health Excellence (NICE) suggests overweight or obese T1DM patients may be considered for adding metformin to insulin therapy. However, metformin is not licenced in UK for T1DM management and the results of a recent clinical trial did not support this NICE recommendation. We therefore would like to know how frequently metformin is used in recent clinical practice in the UK. Participants will be patients aged 18 and older with T1DM diagnosis and no Type 2 diabetes diagnosis registered anytime and at least one insulin prescription between January 1, 2015 and June 30, 2017 after a minimum of 12 months of prior insulin use.
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Methodological guidelines for the use of regression discontinuity designs in clinical settings. — Luke Keele ...
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Methodological guidelines for the use of regression discontinuity designs in clinical settings.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-18
Organisations:
Luke Keele - Chief Investigator - Georgetown University
Manuel Gomes - Corresponding Applicant - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics ResearchOutcomes:
Mortality (all-cause and cardiovascular-related, identified through ONS data); LDL cholesterol (identified from CPRD); Hospital admissions/length-of-stay (HES inpatient data); Cardiovascular events (identified from CPRD/HES diagnoses).
Description: Technical Summary
Routinely-collected data are increasingly used to complement trial-based evidence for evaluating treatment effects of health interventions. The regression discontinuity (RD) design has been identified as a key tool for drawing causal inferences in such settings. While the number of applications of RD designs for studying the effects of health interventions is increasing, appropriate diagnostic tests for investigating the validity of RD designs in clinical settings have received little attention. In addition, statistical methods currently used in practice for the estimation of causal effects and corresponding uncertainty measures are sub-standard. This study will devise methodological guidelines for the use regression discontinuity designs to estimate treatment effects from routinely-collected data. Firstly, drawing on insights from the econometric literature, we will propose appropriate diagnostics tests to help assess whether a specific RD design is applicable. Secondly, we will investigate the required sample sizes for power analyses as a function of bandwidth estimates. Thirdly, we will critically assess alternative estimation approaches, including bandwidth estimation, for drawing causal inferences in RD designs. We will illustrate the methods in a study of the effects of statins on a wide range of outcomes, such as LDL cholesterol level, mortality and health care costs, using CPRD linked data. We will consider statin initiation as a function of cardiovascular disease risk score according to NICE clinical guidelines ('treatment rules') for the UK.
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Risk factors for venous thromboembolism and serious bleeding events in patients with active breast, prostate, ovary, colorectal and lung cancer — Carlos Martinez ...
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Risk factors for venous thromboembolism and serious bleeding events in patients with active breast, prostate, ovary, colorectal and lung cancer
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Systemic Anti-Cancer Treatment (SACT) data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-18
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Laura Franco - Collaborator - University of Perugia
Marjolein Brekelmans - Collaborator - University of Amsterdam
Savino Sciascia - Collaborator - University of TorinoOutcomes:
Venous thromboembolism; Serious bleeding.
Description: Technical Summary
This study aims to determine predictors for the risk of venous thromboembolism (VTE) and separately for serious bleeding events in patients with one of the following five active cancer types: breast, prostate, ovary, colorectal and lung cancer. Active cancer will be defined as the 6 month period following a first cancer diagnosis, a subsequent diagnosis of cancer progression or cancer-specific therapy. The active cancer cohort will be stratified by the 5 cancer types and followed separately for the first occurrence of a clinical outcome of interest, either a VTE event or a serious bleeding event. Exposures of interest for each study outcome and for each cancer type are cancer-specific information (e.g. histology, stage and tumour size) and cancer-specific therapy (i.e. chemotherapy, cytotoxic drugs, radiotherapy, hormonal therapy and immunotherapy). Adjusted hazard rate ratios of the association between the exposures of interest and the clinical outcomes will be derived for each outcome and for each cancer type from multivariate Cox regression models. Estimates will be adjusted for co-morbidities, co-medications, patient demographics and lifestyle factors.
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A cohort study to identify physical and mental diagnoses associated with a subsequent diagnosis of attention deficit-hyperactivity disorder (ADHD) in children and young people using primary care and linked data. — Vibhore Prasad ...
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A cohort study to identify physical and mental diagnoses associated with a subsequent diagnosis of attention deficit-hyperactivity disorder (ADHD) in children and young people using primary care and linked data.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-08
Organisations:
Vibhore Prasad - Chief Investigator - King's College London (KCL)
Vibhore Prasad - Corresponding Applicant - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Patrick White - Collaborator - King's College London (KCL)
Peter Schofield - Collaborator - King's College London (KCL)Outcomes:
The association of mental and physical health disorders with a subsequent diagnosis of attention deficit-hyperactivity disorder (ADHD)
Description: Technical Summary
Background and rationale
Attention deficit-hyperactivity disorder (ADHD) is common in children and young people (CYP). Previous work in the Clinical Practice Research Datalink (CPRD) suggests around 1% of CYP have a recorded diagnosis of ADHD, in contrast to a community prevalence of 3-5%, which suggests an under-recognition of ADHD. An exploration of mental and physical diagnoses recorded in the health care records and their association with a diagnosis of ADHD is currently lacking. In addition, although there have been studies of the association of ADHD with other mental health diagnoses, currently little is known about the association of mental and physical health disorders in CYP with ADHD in English primary care.
Objectives:
To ascertain events that predict the risk of a diagnosis of ADHD through an analysis of primary and secondary care medical records.
Methods:
To undertake a cohort study and a nested case control study of children and young people with and without ADHD.
Analysis:
To identify common physical and mental health diagnoses that may be associated with ADHD and quantify the associations in children and young people with ADHD compared to those without. To estimate the predicted risk of ADHD given previous mental and physical diagnoses.
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Dementia and Musculoskeletal Pain: Consultation and Treatment Patterns in Primary Care — John Bedson ...
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Dementia and Musculoskeletal Pain: Consultation and Treatment Patterns in Primary Care
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-12-18
Organisations:
John Bedson - Chief Investigator - Keele University
Laurna Bullock - Corresponding Applicant - Keele University
Laurna Bullock - Collaborator - Keele University
Paul Campbell - Collaborator - Keele University
Ying Chen - Collaborator - Keele UniversityOutcomes:
Primary outcomes:
- Musculoskeletal consultation
- Analgesic prescriptionsDescription: Technical Summary
Objective:
The objective of the project is to describe the epidemiology (prevalence, incidence) of MSK consultations in a cohort of people with dementia compared to a matched cohort, and to investigate the longitudinal development pattern of pain consultations and pain treatments in the dementia cohort compared to a matched cohort.
Methods:
We will identify people with a diagnosis of dementia registered with general practices in the Clinical Research Practice Datalink (CPRD) between 1997-2017. People with dementia will be compared to a year of birth, sex, and practice matched cohort with no evidence of dementia diagnosis.
Data Analysis:
A retrospective matched cohort design will be used to investigate the four aims of the project. Firstly, period prevalence and incidence rates of MSK pain consultations for the dementia cohort and matched cohort will be calculated and compared. In addition, the drug count and pattern of analgesic prescriptions will be explored for the dementia cohort compared to the matched cohort using regression analyses (multinomial and multiple). Finally, longitudinal analysis will be conducted from pre-to-post index date (dementia diagnosis or equivalent date for matched cohort) for both the dementia and matched cohorts to investigate MSK consultation frequency and analgesic prescription frequency using joinpoint regression.
Source
2017 - 11
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Treatment Patterns and Characteristics of Patients with Uterine Fibroids in the UK: A Retrospective Cohort Study — Nawal Bent...
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Treatment Patterns and Characteristics of Patients with Uterine Fibroids in the UK: A Retrospective Cohort Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-24
Organisations:
Nawal Bent-Ennakhil - Chief Investigator - Adelphi Real World
Rafal Jakubanis - Corresponding Applicant - Deep Sense ai
Adam Roughley - Collaborator - Adelphi Real World
Alice Wang - Collaborator - AbbVie Inc. USA (Headquarters)
James Piercy - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Stuart Blackburn - Collaborator - Adelphi Real WorldOutcomes:
1. Baseline demographics and clinical characteristics, including age, BMI, Charlson's comorbidity index, number of gynaecologist visits within the pre-index period
2. Treatment patterns - first Uterine Fibroids (UF) related treatment prescribed, time to treatment initiation, treatment dynamics (continuous use, discontinuation, direct switch, retreatment with index drug or another UF drug, augmentation; as detailed in section N. Data/ Statistical Analysis)
3. Resource use - complications after the first surgical treatment for UF, UF-related hospitalisations and emergency admissions within the follow-up period, number of gynaecologist visits in the follow-up period.Description: Technical Summary
Female patients aged 18-54 years old will be identified (indexed) on their first UF-coded event.
As we want to capture treatment patterns for new episodes of UF, a pre-index period of 12 months with no UF-coded events is required. A 12-month pre-index window gives us a reasonable degree of confidence that the index date is in fact a new episode of UF.
Treatment patterns will be investigated within the 24 months post index date. Baseline characteristic will be assessed in the pre-index period and values closest to the index date will be used.
To assess the use of UPA, the study design will be modified to capture more patients prescribed UPA; the indexing period will be extended by 12 months to 36 months, and the follow-up period reduced from 24 months to 12 months.
The study will be mainly descriptive, with elements of comparative analysis between UPA vs. non-UPA patients who received other pharmaceutical treatments. Negative binomial regression models will be constructed, with elements of HCRU as the outcome, UPA vs. non-UPA as the exposure and adjusting for confounding factors outlined in section M. In addition, these regression models will adjust for patient-level differences in length of exposure.
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Estimation of the proportion of paediatric, adolescent and adult asthma patients according to modified GINA guidelines — Juanzhi (Jenny) Fang ...
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Estimation of the proportion of paediatric, adolescent and adult asthma patients according to modified GINA guidelines
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-03
Organisations:
Juanzhi (Jenny) Fang - Chief Investigator - NOVARTIS
- Corresponding Applicant -
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence of asthma defined by GINA guidelines.
Description: Technical Summary
The aim of this study is to calculate the number and percentage of patients in each of the Global Initiative for Asthma (GINA) steps outlined in the GINA guidelines and to estimate the proportion of paediatric, adolescent and adults patients within each GINA step. Within these GINA steps we aim to calculate the number of exacerbations that have occurred in the 12 months post index date using both Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) data. The exploration will be performed on two cohorts of prevalent asthma patients on two different calendar years (2014 and 2015). GINA steps will be ascribed based upon therapy combinations prescribed during the index year. Data will be presented in a tabular format with numbers and percentages shown.
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Outcomes following empirical antibiotic treatment of suspected urinary tract infection in older people in primary care. — Harry Ahmed ...
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Outcomes following empirical antibiotic treatment of suspected urinary tract infection in older people in primary care.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-22
Organisations:
Harry Ahmed - Chief Investigator - Cardiff University
Harry Ahmed - Corresponding Applicant - Cardiff University
Christopher Butler - Collaborator - Cardiff University
Daniel Farewell - Collaborator - Cardiff University
Nicholas Francis - Collaborator - Cardiff University
Shantini Paranjothy - Collaborator - University of AberdeenOutcomes:
Primary care re-consultation; Hospitalisation for pyelonephritis; Death; Primary care antibiotic prescription; Hospitalisation for sepsis; UTI related hospitalisation; Hospitalisation for acute kidney injury.
Description: Technical Summary
Urinary tract infections (UTIs) are a common cause of morbidity in older people. Most older people with a suspected UTI consult their GP and may receive a prescription for empirical antibiotics. Little is known about rates of adverse outcomes following this approach, nor about associations between different empirical antibiotic prescribing strategies and outcomes, especially in higher risk groups, e.g., those with impaired renal function. There is also uncertainty around the optimal duration of treatment in this population, with limited evidence for the current practice of three-day therapy in women and seven-day therapy in men. This study will address these evidence gaps using linked CPRD GOLD, HES admitted patient care, and ONS death registry data. We will compare outcomes for different antibiotic prescribing strategies in patients aged >65 empirically treated for suspected UTI in primary care, and estimate risks of adverse outcomes according to renal function. We will explore potential predictors of early serious adverse outcomes. We will use multivariable logistic regression and propensity score-matching methods to estimate risk ratios and adjust for a range of confounding variables. Our research will inform clinical practice by providing evidence for appropriate empirical antibiotic prescribing for older people presenting to primary care with suspected UTI.
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Exploratory study of cardiovascular risk in early type 2 diabetes — Lise Lotte Nystrup Husemoen ...
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Exploratory study of cardiovascular risk in early type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-17
Organisations:
Lise Lotte Nystrup Husemoen - Chief Investigator - Novo Nordisk
Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk
Christin Loeth Hertz - Collaborator - Novo Nordisk
Emina Mocevic - Collaborator - Novo Nordisk
Johanne Spanggaard Piltoft - Collaborator - Novo Nordisk
Kamlesh Khunti - Collaborator - University of Leicester
Mikhail Kosiborod - Collaborator - University of Missouri-Kansas City School of Medicine
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk
Stephen Bain - Collaborator - Swansea UniversityOutcomes:
Individual cardiovascular risk factors; 10-year cardiovascular risk estimated by the Framingham risk score model; Risk of coronary heart disease (CHD) and stroke estimated by UKPDS risk engines; Composite endpoint of CVD mortality, AMI or stroke; Composite endpoint of CVD mortality, AMI, Stroke, hospitalisation for unstable angina hospitalisation for heart failure, or coronary revascularisation; All-cause mortality.
Description: Technical Summary
This study aims to characterise the cardiovascular risk profile of patients with T2D treated with 1st line anti-diabetic (AD) therapy and about to initiate 2nd line anti-diabetic (AD) therapy. The study will use a CPRD data extract on T2D patients initiating 2nd line AD therapy in year 2001 or later as the basis for a cross-sectional study and a cohort study. In the cross-sectional study, the CVD risk profiling will be conducted by describing the distribution of established CVD risk factors in the year prior to initiating 2nd line AD therapy and by describing the overall CVD risk for this population using the Framingham risk score model and the UKPDS risk engines for estimation of risk of primary events of CVD, stroke and Coronary Heart Disease (CHD), respectively. In the cohort study, patients will be followed up for CVD events and Cox regression analyses will be used to determine the association of baseline CVD risk and the incidence of CVD. CV risk will be examined overall and in selected subgroups expected to have a particular high CV risk. The study will provide knowledge of whether certain subpopulations of T2D patients could potentially benefit from additional CV preventive treatment.
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Metabolic effects in children and adolescents treated with psychotropic medication in primary care — Eibert ( Rob ) Heerdink ...
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Metabolic effects in children and adolescents treated with psychotropic medication in primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-17
Organisations:
Eibert ( Rob ) Heerdink - Chief Investigator - University Medical Centre Utrecht
Patrick Souverein - Corresponding Applicant - Utrecht University
Arief Lalmohamed - Collaborator - University Medical Centre Utrecht
E. van den Ban - Collaborator - Karakter Child and Adolescent Psychiatry
Lenneke Minjon - Collaborator - Utrecht University
Marloes Bazelier - Collaborator - Utrecht University
Toine Egberts - Collaborator - Utrecht UniversityOutcomes:
Metabolic screening rates; Test results of metabolic screening.
Description: Technical Summary
Second generation antipsychotics (SGAs) can cause severe metabolic side effects. A retrospective cohort study of children, adolescents and young adults (<24 years old) receiving SGAs between 2000-2015 will be performed. Metabolic screening rates and the test results will be determined. The metabolic screening includes measurement of physical and laboratory parameters. Predictors of metabolic screening that are investigated include age, gender, psychiatric and somatic diagnoses, use of other medication, baseline values, type of SGA, metabolic screening test results, frequency of medical office visits, referrals. We will compare the study group with two control groups: - Patients using antidepressants: to assess whether a psychiatric disorder and the use of antidepressants may influence the metabolic screening rate and test results. - Patients using salbutamol: to compare to a control group where we expect no metabolic screening. The patients will be matched by year of birth, gender, general practice and index date (start medication). The rate of metabolic screening and test results in the three different groups will be compared. We will use the t-test.
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Proton pump inhibitors and mortality: a cohort study — Ian Douglas ...
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Proton pump inhibitors and mortality: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-15
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Chris Frost - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Christopher Lee - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Corentin Ségalas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ikpemesi Olubor - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Isabel dos-Santos-Silva - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jack Collis - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - GSK
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Peter Fisher - Collaborator - UCL Hospital
Stephen Evans - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
Proton pump inhibitors (PPIs) have been associated with a range of adverse outcomes including death. It is likely that many of these associations are not causal but due to confounding. Concern about adverse effects may reduce prescribing of this important class of medications. Therefore, we will examine cause-specific mortality including outcomes unlikely to be causally associated with PPIs.
We will use a cohort study design to estimate the risk of death in new users of PPIs compared to new users of H2 receptor antagonists (H2RAs) and, in a secondary analysis, to non-users of acid suppression therapy.
The outcomes of interest are all-cause and cause-specific mortality. For cause-specific mortality we will include both broad categories of cause of death (i.e. neoplasms) and selected specific causes. We will include specific causes related to adverse events previously found to be associated with PPI usage (e.g. pneumonia) and Âcontrol outcomes (e.g. liver cancer mortality), which may be associated with frailty, but which have not been previously linked to PPIs.
Inverse probability of treatment weighting by propensity score, calculated using logistic regression, will be used to control for confounding. Cox regression will be used to estimate the effect of PPI prescription on risk of death.
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Examining if primary care consultation patterns can identify children who go on to develop severe chronic kidney disease: a case-control study. — Yoav Ben...
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Examining if primary care consultation patterns can identify children who go on to develop severe chronic kidney disease: a case-control study.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-21
Organisations:
Yoav Ben-Shlomo - Chief Investigator - University of Bristol
Lucy Plumb - Corresponding Applicant - University of Bristol
Fergus Caskey - Collaborator - University of Bristol
Manish Sinha - Collaborator - Guy's & St Thomas' NHS Foundation Trust
Matthew Ridd - Collaborator - University of Bristol
Stephanie MacNeill - Collaborator - Imperial College London
Theresa Redaniel - Collaborator - University of BristolOutcomes:
 Incident children with severe chronic kidney disease.
 Validation of CPRD READ codes for severe childhood chronic kidney disease.
 Predictive value of symptoms and consultation patterns for severe kidney disease in children.Description: Technical Summary
Chronic kidney disease (CKD) is a significant burden for patients, families and the NHS. CKD progression in childhood not only impacts upon growth, development and schooling, but means a lifetime of renal replacement therapy once end-stage disease is reached. As disease advances, complications relating to kidney function decline are anticipated and may cause symptoms prompting medical review. Medical treatments can slow/delay CKD progression if identified early.
Objective: To explore primary care use and symptoms reported by children who go on to develop severe CKD. This will help us to describe important factors relating to progression of childhood CKD which may help improve detection.
Methods: A nested case-control study will compare symptomatology and consultation frequency of children up to 21 years with severe CKD (stages 4/5/RRT) with controls matched for age (within one year), gender, CPRD time-period (reaching matched age within two years either side of index date) and practice (case:control ratio 1:20). The degree of association of symptoms and consultation frequency with CKD will be tested using conditional logistic regression. We will examine the diagnostic utilities of single and combination features and using ROC curve analysis look at various cut-points to help decide on useful test criteria under different assumptions.
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Asthma, chronic obstructive pulmonary disease (COPD) and heart failure: a population-based cohort study of disease sub-classification, disease coexisting, and the underlying biological mechanism. — Harry Hemingway ...
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Asthma, chronic obstructive pulmonary disease (COPD) and heart failure: a population-based cohort study of disease sub-classification, disease coexisting, and the underlying biological mechanism.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-15
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Nat Na-Ek - Corresponding Applicant - Farr Institute of Health Informatics Research
Amitava Banerjee - Collaborator - University College London ( UCL )
Nat Na-Ek - Collaborator - Farr Institute of Health Informatics ResearchOutcomes:
Chronic Obstructive Pulmonary Disease (COPD)
 Cardiovascular mortality
 Chronic Heart Failure (HF)
 Non-cardiovascular mortality
 Asthma
 Standardised mortality ratio (SMR)
 All-cause mortalityDescription: Technical Summary
Data on accurate identification of disease sub-classification and coexisting from a large population-based real-world setting is still lacking. In this study, we aim to develop algorithms to classify subtypes of asthma, chronic obstructive pulmonary disease, and heart failure cases on electronic health records and explore the overlap and distinguish between COPD and HF. To achieve these, first, we will identify subtypes, including HF with reduced ejection fraction (HFrEF), HF with preserved ejection fraction (HFpEF), different degrees of asthma and COPD severity. Second, we will develop algorithms to investigate the temporal relationship between COPD and HF in which patients will be categorised into six groups (i.e., having either COPD or HF, having COPD then develop HF or vice versa, having both simultaneously, and not enough evidence to prove both). Then risk factors and prognosis of each group will be compared. Lastly, we will examine the changes in inflammation markers, including c-reactive protein, lymphocyte, neutrophil, eosinophil, and uric acid between COPD patients who do and do not develop HF. This study will provide an insight into characteristics and burden of disease coexisting, and plausible biological mechanism, which can ultimately result in an improvement in a quality of patient care.
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HIV as a risk factor in the initial presentation of a range of cardiovascular, coronary, cerebrovascular, and peripheral arterial diseases — Spiros Denaxas ...
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HIV as a risk factor in the initial presentation of a range of cardiovascular, coronary, cerebrovascular, and peripheral arterial diseases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-03
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Marina Daskalopoulou - Corresponding Applicant - University College London ( UCL )
Andrew Philips - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
We will use structured, national linked electronic health records from primary care (from the Clinical Practice Research Datalink), hospital care (from Hospital Episode Statistics), and mortality (from the Office of National Statistics) to examine: (i) associations of HIV-serostatus and incidence of heterogeneous cardiovascular, cerebrovascular, and peripheral arterial diseases among individuals with no prior history of these diseases and (ii) how risk factors for these conditions might be differential by HIV status.
Patients registered with consenting general practices will be selected using an open cohort design, and will be censored at first occurrence of disease of interest (any of: stable or unstable angina, non-fatal myocardial infarction, unheralded coronary heart disease death, heart failure, sudden cardiac death, transient ischemic attack, ischemic stroke, subarachnoid haemorrhage, intracerebral haemorrhage, abdominal aortic aneurysm, peripheral arterial disease, and atrial fibrillation), last date of practice data collection, or at end of the study period. For each of the diseases we will: (i) calculate cumulative and excess incidence rates (95%CIs) per 100,000 person-years by HIV-serostatus, (ii) use disease-specific Cox proportional hazards models to derive hazard ratios (95%CIs) for initial presentation by HIV-serostatus (adjusted for relevant covariates) and to assess time trends in relative risk of each CVD by calendar time period.
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Survival Analysis with Machine Learning for Predicting the Risk of Adverse Outcomes — Kazem Rahimi ...
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Survival Analysis with Machine Learning for Predicting the Risk of Adverse Outcomes
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-24
Organisations:
Kazem Rahimi - Chief Investigator - The George Institute for Global Health
Fatemeh Rahimian - Corresponding Applicant - The George Institute for Global Health
Amir Hossein Payberah - Collaborator - The George Institute for Global Health
Dexter Canoy - Collaborator - The George Institute for Global Health
Reza Salimi Khorshidi - Collaborator - The George Institute for Global HealthOutcomes: none known
Description: Technical Summary
We will study patients aged between 18 and 100 years with a valid IMD score, who have been registered in the system at least one year before the beginning of study period. Data for each individual patient is aggregated up until the beginning of study, and is used to predict the risk of an emergency admission during follow-up study periods of different lengths, e.g., 3, 6, 12, 24, and 48 months.
We will first build a Cox Proportional Hazard model1,2, which will serve as a baseline in our comparisons. We will investigate various techniques for preprocessing of data3,4, as well as, for building better prediction models. We will use ensemble-learning techniques such as Random Forest5 and Gradient Boosting Machines6, which have shown to perform well on various types of data. Both these methods carry out simultaneous variable selection and modelling, which makes their use convenient; they also rely on minimal parametric assumptions, which makes their use for mixed-type feature spaces, such as ours, appropriate. More details are provided in section N (Data/ Statistical Analysis).
Source - and 8 more projects — click to show
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Healthcare Resource Utilization and Costs among Patients with and without Infection after Intramedullary Nailing for A Tibial Shaft Fracture — Abhishek Chitnis ...
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Healthcare Resource Utilization and Costs among Patients with and without Infection after Intramedullary Nailing for A Tibial Shaft Fracture
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-27
Organisations:
Abhishek Chitnis - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Abhishek Chitnis - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Chantal Holy - Collaborator - Johnson & Johnson ( JnJ - USA )
David Wei - Collaborator - Johnson & Johnson ( JnJ - USA )
Konstantina Paparouni - Collaborator - Synthes GmbH
Peter-Panagiotis Giannoudis - Collaborator - University of Leeds
Simone Wolf - Collaborator - Synthes GmbH
Thibaut Galvain - Collaborator - Johnson & Johnson Medical SASOutcomes:
Short term (30-day, 90-day) and mid-term (one-year, two-year) healthcare costs among patients with deep infection and superficial infection versus patients without infection; Short term (30-day, 90-day) and mid-term (one-year, two-year) healthcare resource utilization (HRU) among patients with deep infection and superficial infection versus patients without infection
Description: Technical Summary
The objective of this retrospective longitudinal cohort study is primarily designed to determine short (30-day, 90-day) and mid-term (one-year, two-year) healthcare resource utilization (HRU) and costs among patients with deep and superficial infections versus those without following intramedullary nailing for a tibial shaft fracture. Patients with tibial shaft fracture treated with intramedullary nailing between 2011 and 2016 will be selected. The main exposure variable will include deep infection versus superficial surgical site infection or no infection. Analyses will be both descriptive and comparative using multivariable models. The multivariable models will include generalized linear models (GLMs) based on the outcome variable of interest for HRU and costs and will adjust for patient characteristics.
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Prescribing patterns of glucosamine containing products- a study using CPRD — Sonia Coton ...
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Prescribing patterns of glucosamine containing products- a study using CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-27
Organisations:
Sonia Coton - Chief Investigator - CPRD
Sonia Coton - Corresponding Applicant - CPRD
Chris Jones - Collaborator - MHRA
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
William Whitfield - Collaborator - MHRAOutcomes:
Characteristics of patients receiving a glucosamine product; Prevalence of glucosamine product prescribing.
Description: Technical Summary
The main objective of this study is to describe the demographic and clinical characteristics of patients prescribed GCP to have a better understanding of why they were prescribed the glucosamine product, what products were prescribed, and to determine osteoarthritis diagnosis sub-groups of patients prescribed GCP. Categorical characteristics will be described using number and percent, continuous characteristics will be described using mean and standard deviation (unless the distribution is skewed in which case median and interquartile range will be presented). Prescribing patterns of GCP will be investigated stratified by: diagnosis sub-group of osteoarthritis; form (tablet, powder for oral solution, oral suspension, gel, and cream); and dosage.
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Screening for atrial fibrillation at annual influenza vaccination of patients aged over 65; a cohort study. — Jenny Lund ...
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Screening for atrial fibrillation at annual influenza vaccination of patients aged over 65; a cohort study.
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-03
Organisations:
Jenny Lund - Chief Investigator - University of Cambridge
Jenny Lund - Corresponding Applicant - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Duncan Edwards - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of Cambridge
Silvia (Silva) Mendonca - Collaborator - University of CambridgeOutcomes:
Incidence of new AF diagnosis; Incidence of anticoagulation after diagnosis of AF; Reduction in incidence of new stroke; Reduction in all-cause mortality.
Description: Technical Summary
Beginning in 2008 with a number of locally enhanced service (LES) schemes some GP surgeries have been offering pulse checks at the time of flu vaccination to detect asymptomatic AF. Its presence leads to a fivefold increase in the risk of stroke, a risk that can be reduced with the use of anticoagulant medication. In this project we aim to investigate three linked aims. Firstly, whether the practice of checking a pulse with a flu vaccination increases the incidence of detected AF and in those with detected AF whether there is any difference in the incidence of stroke between those who were pulse checked with flu vaccination and those who were detected otherwise. Secondly whether patients with newly detected AF are offered anticoagulation and whether the rates of anticoagulation differ between the pulse checked and detected otherwise groups. Thirdly we will investigate whether there is a reduction in the proportion of the pulse checked group who experience a stroke or death. The first two aims will be descriptive in nature, the third will be investigated with a survival analysis, both unadjusted and adjusted for Age, sex, practice level IMD score and multi-morbidity score.
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Comparative effectiveness of 4th line anti-hypertensive agents in patients with resistant hypertension; a population based cohort study — Sarah...
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Comparative effectiveness of 4th line anti-hypertensive agents in patients with resistant hypertension; a population based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-28
Organisations:
Sarah-Jo Sinnott - Chief Investigator - Not from an Organisation
Sarah-Jo Sinnott - Corresponding Applicant - Not from an Organisation
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Pablo Perel - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
Resistant Hypertension (RH) is defined as blood pressure that remains ?140/90mmHg despite being treated with maximum, or best tolerated, doses of ?3 antihypertensive agents, one of which should be a diuretic. People with RH have double the risk of cardiovascular events than those with standard hypertension.
At present, there is a dearth of clear evidence on which to base treatment recommendations for RH. The strongest evidence to date, which supports the use of spironolactone, is limited by short follow-up time and lack of hard clinical outcomes, such as myocardial infarction, stroke and death.
We will use linked primary care-hospital data to conduct an observational study examining the comparative effectiveness of different fourth line anti-hypertensive agents in RH, for example comparing spironolactone to a beta-blocker, an alpha-blocker or other. We will use a propensity score approach to control for confounding, and Cox-Proportional Hazard models to model the primary outcome: a composite of death, myocardial infarction and stroke. Secondary outcomes will include the individual components of the primary outcome along with cardiovascular mortality, end stage renal disease, heart failure and changes in blood pressure. Adverse events such as hyperkalaemia and gynecomastia will also be analysed.
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Nalmefene use in the UK: prescribing patterns and influences — Clare Sharp ...
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Nalmefene use in the UK: prescribing patterns and influences
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-06
Organisations:
Clare Sharp - Chief Investigator - University of Stirling
Clare Sharp - Corresponding Applicant - University of Stirling
Andrew Elders - Collaborator - Glasgow Caledonian University
Linda Bauld - Collaborator - University of Stirling
Niamh Fitzgerald - Collaborator - University of Stirling
Roy Robertson - Collaborator - Muirhouse Medical GroupOutcomes: none known
Description: Technical Summary
This study aims to understand how nalmefene has been used in UK primary care, and explore what factors might influence its prescribing. A simple descriptive analysis will be conducted using CPRD data on all patients prescribed nalmefene since it was licensed in the UK in May 2013. This includes a description of their key characteristics, drinking behaviour and diagnoses, and nalmefene prescribing details.
Descriptive analysis of a random sample of individuals with alcohol dependence who have not received nalmefene will also be conducted to explore key characteristics, drinking behaviour and any treatments received, including other drug therapies and psychological therapies. Some comparisons with the nalmefene patients may be made where possible although the two groups may not be directly comparable. This data will be restricted to individuals who have been diagnosed since May 2013, to coincide with the date that nalmefene was available to prescribe in the UK. A list of READ codes used to define alcohol dependence will be provided, drawing on the code list from a previously published study which used CPRD data
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 1 - Replication of "Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study" — Shirley Wang ...
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Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 1 - Replication of "Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study"
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-24
Organisations:
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
Adherence to urate-lowering treatment (ULT) medications.
Description: Technical Summary
This objective of this protocol is to replicate the study: 'Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study?' by Kuo et al. based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Kuo paper describes adherence to urate lowering treatment in the UK general population with prevalent of incident gout between 1997 and 2012. We will focus on replicating the outcome of adherence to urate lowering treatment for prevalent and incident gout patients over this time period. Adherence in prevalent gout patients will be measured using proportion of days covered (PDC). PDC will be calculated as the proportion of days on which a patient had available prescriptions for urate lowering treatment over intervals defined as the period from the latest of registration date or 1 January to the earliest of transfer-out, death date or 31 December in each calendar year. For incident gout patients, adherence will be measured as percentage of incident gout patients treated with urate lowering treatment at 6 months and 1 year after diagnosis.
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Treatment patterns and medication adherence to fluticasone furoate/vilanterol (FF/VI) and beclometasone/formoterol (BDP/F): a data characterisation study in the CPRD — Annalisa Rubino ...
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Treatment patterns and medication adherence to fluticasone furoate/vilanterol (FF/VI) and beclometasone/formoterol (BDP/F): a data characterisation study in the CPRD
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-03
Organisations:
Annalisa Rubino - Chief Investigator - Evidera, Inc
Annalisa Rubino - Corresponding Applicant - Evidera, Inc
Dimitra Lambrelli - Collaborator - Evidera, Inc
Henrik Svedsater - Collaborator - GSK
John Logie - Collaborator - GlaxoSmithKline - UK
Sharon MacLachlan - Collaborator - Evidera, IncOutcomes: none known
Description: Technical Summary
Asthma management aims to achieve disease control through short-acting medications to treat acute episodes and long-term control medications to control persistent asthma. The latter include Fluticasone furoate/vilanterol (FF/VI, 92/22mcg and 184/22mcg), administered once-daily by a novel dry powder inhaler (DPI), and beclometasone/formoterol (BDP/F; 100/6mcg and 200/6mcg) administered as maintenance treatment at fixed doses via a Metered Dose Inhaler (MDI).
A study has been planned to compare treatment patterns and medication adherence associated with FF/VI 92/22mcg and 184/22mcg versus BDP/F 100/6mcg and 200/6mcg, respectively.
the study will compare FF/VI versus BDP/F in terms of:
- Time to discontinuation
- Exacerbation rates during treatment
- Use of short-acting beta-agonists
- Healthcare resources utilization
These study endpoints are provisional and would be finalized based on the outcome of the initial feasibility assessment.The study will run in two phases:
1. Phase I will verify the feasibility of the study by assessing available data in the CPRD, specifically:
- Dosing instructions for study drugs and other respiratory medications
- Baseline comorbid conditions
- Baseline asthma exacerbation and severity/symptom measures
- Baseline health care resource utilization
2. Phase II, will only commence with Âpositive findings from the feasibility, and will consist of the full study.
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Inhaled corticosteroids, blood eosinophils and lung function (FEV1) decline over time in a primary care COPD cohort — Jennifer Quint ...
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Inhaled corticosteroids, blood eosinophils and lung function (FEV1) decline over time in a primary care COPD cohort
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-11-22
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes: none known
Description: Technical Summary
People with COPD are commonly treated with short or long-acting bronchodilator inhalers. If symptoms persist or patients experience exacerbations of COPD they are put onto inhaled corticosteroids (ICS). However, the risks and benefits of ICS in the treatment of COPD patients have long been debated. Randomized clinical and observational studies have shown that the use of ICS in COPD patients can increase the chances of respiratory infections as well as that they reduce rehospitalisation and exacerbations of COPD. More recently, it is thought that specific subgroups of COPD patients may benefit from ICS treatment more than others. High blood eosinophil counts in COPD patients is one subgroup of interest. This study aims to assess the effect of ICS on lung function decline, particularly FEV1, in a primary care COPD population, stratifying by blood eosinophil levels. Using a mixed effects linear model, we will investigate the decline in lung function in people with prevalent COPD over a 10 year period and compare the rates of decline in patients with high or low eosinophils, who are on and not on ICS to explore who may benefit more from ICS.
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2017 - 10
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Estimation and characterisation of the potential COPD population for triple therapy combining long-acting muscarinic antagonist, long acting ?2-agonist and inhaled corticosteroid. — Juanzhi (Jenny) Fang ...
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Estimation and characterisation of the potential COPD population for triple therapy combining long-acting muscarinic antagonist, long acting ?2-agonist and inhaled corticosteroid.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-08
Organisations:
Juanzhi (Jenny) Fang - Chief Investigator - NOVARTIS
- Corresponding Applicant -
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Segmentation of COPD population; Exacerbations of COPD.
Description: Technical Summary
Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) is associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. Prevention of exacerbations is a key goal in the management of COPD. The primary objective of the study is to estimate the size of the COPD population who may benefit from triple therapy combining long-acting muscarinic antagonist, long acting beta 2-agonist and inhaled corticosteroid that is, the percentage of COPD patients with ?2 exacerbations in one year and with high blood count levels. Secondary objectives include describing the COPD population by number of exacerbations in the index year, by baseline blood eosinophil levels and by cross-tabulating exacerbations with a) eosinophil levels and b) forced expiratory volume (FEV1) levels. We aim to use CPRD database to study a population with COPD in two different cohort years. We then aim to classify these patients by level of eosinophils and both prior and subsequent exacerbations in order to present this data in a tabular format.
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Paediatric Investigation Plans and estimating age in children within the Clinical Practice Research Database (CPRD) — John Logie ...
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Paediatric Investigation Plans and estimating age in children within the Clinical Practice Research Database (CPRD)
Datasets:GP data, CPRD Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-26
Organisations:
John Logie - Chief Investigator - GlaxoSmithKline - UK
John Logie - Corresponding Applicant - GlaxoSmithKline - UK
Harriet Dickinson - Collaborator - GSK
Iain Gillespie - Collaborator - GlaxoSmithKline - UK
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Oksana Kirichek - Collaborator - GSK
Rachael Williams - Collaborator - CPRDOutcomes:
Estimated age; Distribution of neonatal jaundice and initiation of childhood vaccinations by estimated age.
Description: Technical Summary
Unless exempt because of a deferral or waiver, new drug applications to the European Medicines Agency (EMA) require a Paediatric Investigation Plan (PIP) providing data in children to support the authorisation of the medicine for paediatric populations. The potential for drug exposure in all paediatric age groups (neonates, Infant/Toddler, children and adolescents) is assessed and may be compared with adults. Often, the incidence and prevalence of the targeted disease is assessed to describe the potential paediatric population for any new medication. Potentially, CPRD and linked Hospital Episode Statistics (HES) provide a valuable tool to support PIPs. However, assessments requiring specific age-classes are often difficult in real world data sources where date of birth is removed as part of the anonymisation process. This study aims to better understand illness in the very youngest patients by 1. Assessing methods to accurately estimate age-classes, and 2. Understanding how health services are accessed in the first few weeks or months of life, and hence what information may be captured from this period within CPRD and HES. We propose to work closely with CPRD's internal research team to consider any potential ethical questions around attempts to better approximate patient age.
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Association of blood lipids, atherosclerosis and statins with post-stroke cognitive impairment — Zhirong Yang ...
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Association of blood lipids, atherosclerosis and statins with post-stroke cognitive impairment
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-04
Organisations:
Zhirong Yang - Chief Investigator - University of Cambridge
Zhirong Yang - Corresponding Applicant - University of Cambridge
Carol Brayne - Collaborator - University of Cambridge
Darren Toh - Collaborator - Harvard University
Duncan Edwards - Collaborator - University of Cambridge
Efthalia (Lina) Massou - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of Cambridge
Stephen Burgess - Collaborator - University of CambridgeOutcomes: none known
Description: Technical Summary
Post-stroke dementia/cognitive impairment (PSD/PSCI) is common among stroke survivors. There is some observational evidence suggesting that blood lipids and atherosclerosis may be associated with PSD/PSCI, but direct and robust evidence for such associations remains scarce. Limited evidence from randomised controlled trials also indicates the potential for statins use to decrease the risk of PSD/PSCI. The aim of this study is to explore whether blood lipids and atherosclerosis are associated with PSD/PSCI in large representative populations and whether statin treatment appears to reduce this risk.
We will construct a retrospective cohort of adults with first stroke from the Clinical Practice Research Datalink (CPRD). Eligible patients will have no recorded diagnosis of pre-stroke dementia or cognitive impairment. Exposures will be the baseline blood lipids (including total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride), atherosclerosis and the use of statins. Outcome of interest will be the time between first stroke and dementia. Descriptive analysis and modelling analysis will be conducted, followed by several sensitivity analyses. We will adjust the effects of possible confounders and time-varying effects in the analysis.
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Feasibility assessment of the potential post-authorization safety (PAS) study ÂIncidence of pancreatic cancer and thyroid neoplasm among type 2 diabetes patients who initiated exenatide as compared with those who initiated other glucose lowering drugs — Fabian Hoti ...
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Feasibility assessment of the potential post-authorization safety (PAS) study ÂIncidence of pancreatic cancer and thyroid neoplasm among type 2 diabetes patients who initiated exenatide as compared with those who initiated other glucose lowering drugsÂ
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-24
Organisations:
Fabian Hoti - Chief Investigator - Statfinn Oy
Anna Lundin - Corresponding Applicant - EPID Research Oy
Anna Lundin - Collaborator - EPID Research Oy
Jessie Oyinlola - Collaborator - CPRD
Katja Hakkarainen - Collaborator - IQVIA - USA (Headquarters)Outcomes:
Primary outcomes: Pancreatic cancer; Thyroid neoplasm.
Description: Technical Summary
Diabetes is currently one of the major public diseases worldwide and the number of new individuals that are diagnosed is increasing rapidly. Exenatide is a novel treatment for type 2 diabetes mellitus (T2DM) among adults, used as a combination treatment together with other glucose lowering drugs when desirable effects have not been achieved on previous regimens. During the preclinical and clinical development of exenatide some concerns were raised regarding potential pancreatic and thyroid toxicity. This feasibility assessment aims to evaluate whether the Clinical Practice Research Datalink (CPRD) has an adequate population size for conducting a future safety study on the possible association between exenatide use and malignant neoplasm of pancreas, malignant neoplasm of thyroid gland and benign neoplasm of thyroid gland. In this feasibility assessment, the number of exenatide users and comparator drug users will be assessed from the CPRD, and information for estimating the length of exposure to exenatide. The assessed number of users and estimated length of exposure will be used for estimating power for conducting the future safety study in the CPRD. The incidence of the outcome neoplasms will be estimated from national cancer statistics. Similar assessments are being conducted in other selected European databases.
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Real-world comparison of Qvar BAI versus Qvar MDI and all beclometasone MDI for the treatment of asthma based on a UK retrospective database study. — Maud Pacou ...
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Real-world comparison of Qvar BAI versus Qvar MDI and all beclometasone MDI for the treatment of asthma based on a UK retrospective database study.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-16
Organisations:
Maud Pacou - Chief Investigator - Amaris
Drifa Belhadi - Corresponding Applicant - Amaris
Aline Gauthier - Collaborator - Amaris
Bernard Sfeir - Collaborator - Teva Pharmaceuticals Ltd
Calvin Small - Collaborator - Teva Pharmaceuticals Ltd
Clemence Fradet - Collaborator - Amaris
Drifa Belhadi - Collaborator - Amaris
John Holmes - Collaborator - Teva Pharmaceuticals Ltd
Karthik Ramakrishnan - Collaborator - Teva Pharmaceuticals Ltd
Sophie Marguet - Collaborator - AmarisOutcomes: none known
Description: Technical Summary
We will conduct a hypothesis testing study to determine if Qvar via breath-actuated inhaler (BAI) is associated with different real world outcomes compared to Qvar via metered-dose inhaler (MDI) in the United Kingdom (UK). The secondary objective is to compare Qvar BAI to all beclometasone MDI other than Qvar MDI. A sub-analysis will be conducted focusing only on the most recent BAI, Qvar Easi-Breathe. Clinical Practice Research Datalink (CPRD) data will be used. The primary outcome will be asthma control and secondary outcomes will include severe exacerbations, asthma severity, use of rescue medicines and oral corticosteroids, resource utilisation and costs, and treatment patterns. A retrospective, matched cohort analysis will be performed by constructing a sample of patients balanced on confounding variables using the closest propensity score. Propensity scores will be constructed using a logistic regression of the type of prescribed inhaler on confounding factors identified from literature searches and clinical opinion. Logistic regressions will be conducted for binary endpoints, Poisson or negative binomial regressions for count data and Normal distribution for continuous endpoints using the propensity score matched sample.
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What are the factors associated with missed opportunities to diagnose Chronic Obstructive Pulmonary Disease (COPD)? A non-interventional study using the Clinical Practice Research Datalink (CPRD) database. — Alicia Gayle ...
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What are the factors associated with missed opportunities to diagnose Chronic Obstructive Pulmonary Disease (COPD)? A non-interventional study using the Clinical Practice Research Datalink (CPRD) database.
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-26
Organisations:
Alicia Gayle - Chief Investigator - Imperial College London
Alicia Gayle - Corresponding Applicant - Imperial College London
Deborah Clarke - Collaborator - Boehringer-Ingelheim - UK
Eleonora Skentzou - Collaborator - Boehringer-Ingelheim - UK
Graham Burns - Collaborator - Boehringer-Ingelheim - UK
Jean Lotoya Binns - Collaborator - Boehringer-Ingelheim - UK
Joe Lipworth - Collaborator - Boehringer-Ingelheim - UK
Scott Dickinson - Collaborator - Boehringer-Ingelheim - UKOutcomes:
Time to diagnosis of COPD; Factor associated with time to diagnosis; Characteristics of patients prior to diagnosis of COPD.
Description: Technical Summary
This study is a non-interventional cohort study using CPRD data, with the aim of examining missed opportunities to diagnose COPD. Research suggests that opportunities to diagnose COPD at early disease stages are being missed, and that delays of diagnosis can take up to 20 years. As a result, the objective of this study is to investigate the drivers behind these delays, by comparing cases in which patients were diagnosed with COPD at an earlier stage to cases in which patients were diagnosed at a much later stage of the disease. Multivariate regression analysis will be used to identify drivers of delay in diagnosis and describe how these factors change according to disease severity at diagnosis. The results of this study can be used to determine which patient groups are at high risk of being diagnosed later and with more severe disease prognosis, and support active case finding, to ensure that earlier diagnosis of COPD takes place when possible, and that patients are then treated accordingly.
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Improving statistical methods for estimating treatment effects from electronic health records in health economic evaluation. — Manuel Gomes ...
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Improving statistical methods for estimating treatment effects from electronic health records in health economic evaluation.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-05
Organisations:
Manuel Gomes - Chief Investigator - University College London ( UCL )
Manuel Gomes - Corresponding Applicant - University College London ( UCL )
Gianluca Baio - Collaborator - University College London ( UCL )
James Carpenter - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Richard Grieve - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
Big observational data are increasingly used to complement trial-based evidence on treatment effects for cost-effectiveness analysis (CEA) of health interventions. However, a major concern is that these studies may be biased due to time-varying confounding. A closely related problem is that outcomes and confounders tend to be incomplete, which further increases the risk of bias, and raises additional challenges for tackling the confounding. Recent progress has been made in statistical methods for addressing confounding in CEA, but these developments have been limited to settings with time-invariant, observed confounding, and no missing data.
This study will develop appropriate methods for tackling time-varying confounding and missing data in CEA that use routinely-collected data. Firstly, we will propose a new statistical approach (combination of marginal structure models with multiple imputation) for jointly handling observed time-varying confounding and missing data in CEA, and compare it with existing methods (for example, inverse-probability weighting approaches for handling the missing data). Secondly, we will develop a sensitivity analysis framework for assessing the impact of departures from standard assumptions, such as 'no unobserved confounding' and missing-at-random. Thirdly, we will consider how decision-analytical cost-effectiveness models can incorporate uncertainty from confounding and missing data, and assess the implications for decision-making.
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AChEIs and the Risk of Acute Ischemic Events and Bleeding in Patients with AD — Faleh Tamimi ...
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AChEIs and the Risk of Acute Ischemic Events and Bleeding in Patients with AD
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-05
Organisations:
Faleh Tamimi - Chief Investigator - McGill University
Faleh Tamimi - Corresponding Applicant - McGill University
Belinda Nicolaue - Collaborator - McGill University
Faez Al-Hamed - Collaborator - McGill University
Igor Karp - Collaborator - University Of Western Ontario
Iskandar Tamimi - Collaborator - McGill University
Sreenath Arekunnath - Collaborator - McGill UniversityOutcomes:
Primary: Bleeding events
- Secondary: Stroke
- Secondary: unstable angina and deathDescription: Technical Summary
Antiplatelet therapy is the cornerstone of secondary prevention of acute ischemic events in patients with cardiovascular diseases (CVD). Acute and long-term management of patients with CVD has drastically improved their survival; patients live longer on chronic cardiovascular therapy, which creates the potential for drug-drug interactions in the context of polypharmacy, especially in the elderly.
Cognitive impairment and dementia occur in 5% to 10% of people aged >65 years, and affect up to 30% of those >80 years of age. The most common form of dementia, Alzheimer's disease (AD), is treated with anticholinesterases (AChEIs). In addition to their beneficial effects on acetylcholine levels in the brain, our animal research shows that they may also have antiplatelet effects. AChEIs are associated with lower risk of myocardial infarction and death in humans. Furthermore, our published and ongoing work suggests that administration of AChEIs in mice decreases the level of urinary epinephrine, a known sensitizing agent for platelet activity. Therefore, we hypothesize that the use of AChEIs decreases the risk of ischemic stroke, unstable angina, and death, but increases the risk of bleeding in AD patients, especially in those already on antiplatelet therapy
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Healthcare resource utilization among patients diagnosed with Systemic Sclerosis-associated Interstitial Lung Disease in the United Kingdom: An observational study using the Clinical Practice Research Datalink - INTERSTELLAR — Chris D Poole ...
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Healthcare resource utilization among patients diagnosed with Systemic Sclerosis-associated Interstitial Lung Disease in the United Kingdom: An observational study using the Clinical Practice Research Datalink - INTERSTELLAR
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-08
Organisations:
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Alicia Gayle - Corresponding Applicant - Imperial College London
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
James Richardson - Collaborator - Boehringer-Ingelheim - UK
Margarida Alves - Collaborator - Boehringer-Ingelheim International GmbH
Nils Schoof - Collaborator - Boehringer-Ingelheim Germany
Prithwiraj Das - Collaborator - Boehringer-Ingelheim - UK
Toby Maher - Collaborator - Royal Brompton HospitalOutcomes:
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Description: Technical Summary
Published research suggests that the burden of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), both clinical and economic, is substantial; however, evidence regarding characteristics of patients with SSc-ILD is limited, as are assessments of health care resource utilisation and costs incurred during management of SSc-ILD. This study aims to assess healthcare resource utilisation and costs among patients with SSc-ILD. Demographics, comorbidities and medication history will be described for the cohort of SSc patients and the sub-cohorts of ILD and for patients with other organ involvement (OOI). Health care resource utilisation and costs will be summarised for the overall study sample and for the SSc-ILD SSc-OOI sub-cohorts stratified by service setting, cause of use (SSc/non-SSc related), and by treatment type. We will also conduct multivariable regression analyses using backwards selection methods to examine predictors of adjusted total all-cause and SSc-related health care costs. The results derived from this non-interventional study based on existing data will help quantify the clinical and economic burden of SSc-ILD in real-world settings and demonstrate the existing unmet needs among patients with SSc-ILD. Furthermore, results may be included as inputs in future economic models developed for evaluating the cost-effectiveness of SSc-ILD treatment options.
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Investigating mortality risks up to and after the first presentation of cardiovascular disease: a cohort study using linked CPRD primary care, hospital admission and mortality data — Spiros Denaxas ...
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Investigating mortality risks up to and after the first presentation of cardiovascular disease: a cohort study using linked CPRD primary care, hospital admission and mortality data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-08
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Christof Prugger - Corresponding Applicant - Charite - University Of Medicine Berlin
Christof Prugger - Collaborator - Charite - University Of Medicine Berlin
Harry Hemingway - Collaborator - University College London ( UCL )
Jean-Philippe Empana - Collaborator - Inserm-transfert
Kenan Direk - Collaborator - University College London ( UCL )
Marie-Cecile Perier - Collaborator - Inserm-transfert
Muriel Tafflet - Collaborator - Inserm-transfert
Tobias Kurth - Collaborator - Charite - University Of Medicine BerlinOutcomes: none known
Description: Technical Summary
Epidemiological research in cardiovascular disease (CVD) is traditionally divided into incidence and prognostic studies investigating respectively the period up to and the periods after the occurrence of CVD events. Investigations are rare that combine these two periods among healthy individuals and survivors of CVD within the same study population. Such studies allow researchers to compare patients from primary and hospital care with regard to mortality risk using the period up to CVD events as baseline risk period. This cohort study therefore jointly examines data from the general population (CPRD) and CVD patients (HES) in relation to disease-free survival and post-CVD prognosis (ONS). Healthy individuals enter the cohort in primary care and are followed up for mortality up to and after the initial presentation of 11 CVD phenotypes. Cox proportional hazard models will be used to estimate the effect of intercurrent non-fatal CVD events on CVD, non-CVD, and all-cause mortality. With this unified approach we will assess whether initial presentation of different CVD phenotypes has heterogeneous effects on the subsequent prognosis and possible explanations for such heterogeneities by differences in primary and/or secondary prevention. The study results may enable researchers to identify best practices and missed opportunities in current healthcare services.
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Derivation and validation of a clinical algorithm to predict patient cholesterol response to the initiation of statins and cardiovascular outcomes. — Stephen Weng ...
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Derivation and validation of a clinical algorithm to predict patient cholesterol response to the initiation of statins and cardiovascular outcomes.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-04
Organisations:
Stephen Weng - Chief Investigator - University of Nottingham
Stephen Weng - Corresponding Applicant - University of Nottingham
Barbara Iyen - Collaborator - University of Nottingham
Joe Kai - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Ralph Kwame Akyea - Collaborator - University of NottinghamOutcomes:
Primary Primary Outcomes:
- Change in total cholesterol over time (continuous)
- Change in LDL cholesterol over time (continuous)Secondary Outcomes:
- Long term follow-up for development of cardiovascular disease (coronary heart disease, stroke, transient ischaemic attack and peripheral arterial disease)Description: Technical Summary
Background: There is significant variability in cholesterol lowering and change in cardiovascular disease (CVD) risk when statins are initiated, but no method of predicting response to statin therapy.
Objectives: (1) To determine patient factors, routinely collected in primary care health records, associated with lipid response to statins (2) To derive and validate a clinical algorithm to predict lipid response to statins (3) To determine long term cardiovascular outcomes of patients stratified by lipid response.
Study Design: Cohort study using CRPD data and linked HES, patient-level IMD and ONS-mortality data
Setting: UK General Practice
Participants: Patients free from CVD at baseline, registered at their practice at least one year before study entry, being treated with statins, with at least 2 recorded cholesterol (LDL or TC) readings - the baseline measure being within 12 months before the initiation of statins and follow-up measure being within 24 months after intitiation of statins.
Outcomes: Primary: Change in (1) total cholesterol and (2) LDL cholesterol during 24 month follow-up after initiation of statins; Secondary: First occurence of cardiovascular disease after 24 months from initiation of statins.
Methods: The study population will be randomly split into algorithm derivation and validation cohorts (30% sample). To predict cholesterol response, a repeated measures model (mixed model) will be created. Models will be tested for predictive accuracy in the validation cohort. A time-to-event analysis will investigate relationships between lipid response, patient modifiable and non-modifiable clinical and demographic characteristics, and cardiovascular outcomes.
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Treatment of venous thromboembolism in England: an observational cohort study using Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics databases — Dimitra Lambrelli ...
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Treatment of venous thromboembolism in England: an observational cohort study using Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics databases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-05
Organisations:
Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Robert Carroll - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Anna Schultze - Collaborator - Evidera, Inc
Beth Nordstrom - Collaborator - Evidera, Inc
Raza Alikhan - Collaborator - University Hospital of Wales
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political ScienceOutcomes:
Treatment patterns (including duration/ discontinuation, augmentation and persistence); Recurrent venous thromboembolism (VTE); Major and clinically relevant non-major bleeding; All-cause mortality; Hospitalisations; Hospital length of stay (LOS); Number of GP visits.
Description: Technical Summary
VTE is characterised by the forming of blood clots in blood vessels, and includes deep vein thrombosis (DVT) and pulmonary embolism (PE). In addition to a high case-fatality rate, recurrence is common. Treatment for VTE focuses on inhibiting the function of clotting factors and breaking up existing clots. Traditional treatment involves vitamin-K-antagonists (VKA), most commonly warfarin. However, novel oral anticoagulants (NOACs) are likely to replace warfarin given the evidence of non-inferiority in randomised trials, and their association with reductions in the risk of bleeding. The current study aims to investigate the use and effectiveness of anticoagulants in VTE patients in England. A retrospective cohort study design will be utilised. Patient characteristics, treatment patterns and the risk of clinical events of interest will be compared between patients initiating different OAC treatments. The risk of clinical events of interest will be investigated by treatment class using Kaplan-Meier and Cox-regression analyses. The frequency of all-cause and VTE-related HCRU will be described and rates of use by person-time will be reported. Multivariable modelling will be used to estimate the association of OAC treatment with the rate of HCRU, while controlling for possible confounding factors. Propensity score matching will be used to limit bias/confounding.
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The association between pain clinic attendance and healthcare/medication usage — John Williams ...
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The association between pain clinic attendance and healthcare/medication usage
Datasets:GP data, HES Accident and Emergency; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-17
Organisations:
John Williams - Chief Investigator - University of Nottingham
Brett Doleman - Corresponding Applicant - University of Nottingham
Brett Doleman - Collaborator - University of Nottingham
Roger Knaggs - Collaborator - University of NottinghamOutcomes: none known
Description: Technical Summary
Chronic pain has a prevalence of around 50%. However, few of these patients are treated by pain specialists and many receive inadequate pain relief. Despite this, it is currently unclear what effect referral to pain clinic has on analgesic and healthcare utilisation. Opioids are commonly used to treat patients with chronic pain despite concerns over lack of efficacy, opioid-induced hyperalgesia and adverse events including overdose and potential addiction. It is currently unclear what effect pain clinic attendance has on opioid usage. Furthermore, as chronic pain patients represent high levels of healthcare usage, pain clinic referral may represent an effective strategy to reduce healthcare utilisation. We will examine all patients referred to pain clinic in 2010 and perform a retrospective single group cohort study of those patients taking opioids. Healthcare utilisation and medicine usage for the year before and after referral will be evaluated using linear mixed and Poisson regression.
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The health care use and cost of care before and after the diagnosis of six selected endocrine diseases in UK patients — William Hollingworth ...
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The health care use and cost of care before and after the diagnosis of six selected endocrine diseases in UK patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-17
Organisations:
William Hollingworth - Chief Investigator - University of Bristol
Alexandros Chrysos - Corresponding Applicant - University of Bristol
Alastair Hay - Collaborator - University of Bristol
Stafford Lightman - Collaborator - University of Bristol
Thomas Upton - Collaborator - University of BristolOutcomes:
Health care resource utilisation (primary); Use of diagnostic tests for diagnosis and monitoring (secondary); Cost of health care (primary); Use of medications and other therapies (secondary).
Description: Technical Summary
The endocrine system is a series of glands that secrete hormones into the bloodstream, used to send signals and control bodily functions. Abnormal release of hormones can cause endocrine disorders, which are usually difficult to diagnose. Current clinical practice uses a range of diagnostic tests, though accurate diagnosis may require several visits to primary/secondary/tertiary care physicians. Little is known about the healthcare resources used and the costs of diagnosing and treating these disorders, especially in the UK. This observational study aims to describe and compare the healthcare use and costs of patients with acromegaly, Addison's disease, congenital adrenal hyperplasia, Cushing's syndrome, growth hormone deficiency and/or primary hyperaldosteronism to that of age, gender and GP practice matched general population control groups. Where available, NHS reference costs will be used to micro-cost primary and secondary care use. Simple summary and descriptive statistics (e.g. median (IQR), mean (CI)) will be used to describe healthcare use and costs among each group of patients. Where sample size permits, appropriate statistical methods (e.g. t-tests, GLM regression) will be used to compare healthcare use and costs between each endocrine disorder and the respective control group to estimate the additional costs of diagnosis and treatment for the NHS.
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Natural History of Atrial Fibrillation in the United Kingdom — Rui Providencia ...
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Natural History of Atrial Fibrillation in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-22
Organisations:
Rui Providencia - Chief Investigator - St Bartholomew's Hospital
Rui Providencia - Corresponding Applicant - St Bartholomew's Hospital
Adam D'Souza - Collaborator - University of Calgary
Alexander Wright - Collaborator - University College London ( UCL )
Anthony Hunter - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Bernard Rachet - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Dale - Collaborator - University College London ( UCL )
David Prieto-Merino - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dionisio Acosta Mena - Collaborator - University College London ( UCL )
Fenghua You - Collaborator - University College London ( UCL )
Frances Bennett - Collaborator - University College London ( UCL )
Hannah Evans - Collaborator - University College London ( UCL )
Juan M Garcia-Gomez - Collaborator - Technical University of Valencia
Juan Pablo Casas Romero - Collaborator - University College London ( UCL )
Julian Halcox - Collaborator - Swansea University
Julie Taylor - Collaborator - Farr Institute of Health Informatics Research
Kishore Kukendra-Rajah - Collaborator - University College London ( UCL )
Louis Prosser - Collaborator - University College London ( UCL )
Maria De Iorio - Collaborator - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Nadine Zakkak - Collaborator - University College London ( UCL )
Oliver Mapp - Collaborator - University College London ( UCL )
Pier Lambiase - Collaborator - University College London ( UCL )
Reecha Sofat - Collaborator - University College London ( UCL )
Rohan Takhar - Collaborator - University College London ( UCL )
Rui Providencia - Collaborator - St Bartholomew's Hospital
Samuel Kim - Collaborator - University College London ( UCL )
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
The presentation of atrial fibrillation (AF) varies widely, and its natural history, including causes of death, and development of conditions like cancer, dementia and heart failure following its diagnosis remains to be elucidated. A better understanding of this arrhythmia's natural history and behavior in particular clusters of patients may allow us to develop individualized preventive and therapeutic measures to improve these patients' outcome and quality of life.
Using linked electronic health records from CPRD, HES, ONS, we aim to
Assess the natural history of patients with AF in the UK:
(i) we will describe the event rate and specific causes of mortality and reasons for hospitalizations in patients with a new diagnosis of AF.
(ii) Using time-varying exposure and time-dependent effect models (flexible hazard models), we will investigate if patients with AF have a higher rate of complications (fatal events and non-fatal hospitalizations) than people without AF in the UK.
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Polymyalgia rheumatica in primary care: an epidemiological investigation into occurrence and comorbidities. — Alyshah Abdul Sultan ...
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Polymyalgia rheumatica in primary care: an epidemiological investigation into occurrence and comorbidities.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-16
Organisations:
Alyshah Abdul Sultan - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Richard Partington - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Richard Partington - Collaborator - Keele University
Sara Muller - Collaborator - Keele University
Toby Helliwell - Collaborator - Keele UniversityOutcomes: none known
Description: Technical Summary
Polymyalgia rheumatica (PMR) is a common inflammatory rheumatological condition. Treatment involves low dose glucocorticoids, and is generally effective, although some patients have problems with treatment withdrawal.
The risk of developing PMR varies depending on geographic location. The most recent data from the UK, from 1996 to 2002, showed an incidence of 8 per 10,000 per year in people aged over 40 years.
Little is known about comorbidities that may coexist with PMR. This project will 1) re-estimate the incidence and prevalence of PMR in the UK, 2) measure comorbidities before and after PMR diagnosis. For the first aim: incidence rate per 10,000 years, between 1990 and 2017; and point prevalence on 31st March 2017 will be calculated.
For the second, patients with PMR will be individually matched to four controls. Using a nested case-control study, we will calculate the prevalence of individual comorbidities for cases and controls. Odds ratios (OR) and 95% confidence intervals will be obtained using conditional logistic regression. We will then calculate the cumulative probability of each comorbidity up to 10 years after the index date using Kaplan-Meier plots for comorbidities occurring after PMR diagnosis. We will calculate hazard ratios using Cox regression model.
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A UK population-based cohort study of risk factors for premature death in epilepsy — Leone Ridsdale ...
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A UK population-based cohort study of risk factors for premature death in epilepsy
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-30
Organisations:
Leone Ridsdale - Chief Investigator - King's College London (KCL)
Gabriella Wojewodka - Corresponding Applicant - King's College London (KCL)
Gabriella Wojewodka - Collaborator - King's College London (KCL)
Mark Ashworth - Collaborator - King's College London (KCL)
Mark Richardson - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes: none known
Description: Technical Summary
Epilepsy is the fifth highest treatable cause of death before 75 for males, and eighth highest for females; this situation is worsening, rather than improving. It may be possible to avert deaths by identifying those at risk and offering extra guidance. Our aim is to find what are the avoidable risk factors for death in epilepsy that can be identified using routinely available GP electronic data?
We will conduct a cohort study using data form the Clinical Practice Research Datalink (CPRD), supplemented by Office of National Statistics data. Available will be 14 million patient records, containing 140,000 records of people with epilepsy (PWE), with estimated 1,200 epilepsy-related deaths.
Exposure data includes: alcohol overuse, depression, substance misuse, injury (e.g. accidents), self-injury, overdose and suicide attempts, a record of seizure free status, adherence to antiepileptic drugs, smoking, and predictors of vascular disease (including hypertension). We will report the risks of premature death in epilepsy for each variable.We believe this will provide potent evidence with which SUDEP Action and others can advocate for routine identification of risk, the provision of step-up approaches to management of epilepsy, and mortality-prevention in UK primary care.
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The association between continuity of primary care and mortality and emergency hospitalisation for older patients with complex multimorbidity — Anas El Turabi ...
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The association between continuity of primary care and mortality and emergency hospitalisation for older patients with complex multimorbidity
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-26
Organisations:
Anas El Turabi - Chief Investigator - University of Cambridge
Martin Roland - Collaborator - University of Cambridge
Simon Griffin - Collaborator - University of CambridgeOutcomes:
All cause mortality (PRIMARY); Routine hospitalisation (SECONDARY); Emergency hospitalisation (PRIMARY); GP consultation rate (SECONDARY); Primary care antibiotic prescription rate(SECONDARY).
Description: Technical Summary
Relational continuity of care between patients and GPs is an important aspect of primary care provision. There are however concerns that such continuity has declined, and will continue to do so in coming years as a result of increased service demands and macro level trends in primary care workforce. A better understanding of the relationship between relational continuity and important healthcare outcomes can help practices, patients and policymakers make better decisions about how much to prioritise relational continuity over other priorities (such as extended access). Specifically, a better understanding of whether continuity of care is associated with lower healthcare utilisation and better outcomes for older patients with multiple morbidities will become increasingly important as this group increases in number in coming years. We aim to use anonymised data from primary care medical records to quantify the association between continuity of care and two primary outcomes: rates of emergency hospitalisation and all-cause mortality. Using data from the Clinical Practice Research Datalink (CPRD) we will conduct a retrospective cohort analysis to quantify the strength of association between continuity of care at baseline and subsequent rates of hospitalization and death, using proportional hazard models adjusted for likely confounders, with subgroup analysis conducted for older patients with complex multimorbidity.
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Primary care prescriptions of nephrotoxic medications in children with a previous episode of acute kidney injury or with a diagnosis of chronic kidney disease — Samy Suissa ...
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Primary care prescriptions of nephrotoxic medications in children with a previous episode of acute kidney injury or with a diagnosis of chronic kidney disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-11
Organisations:
Samy Suissa - Chief Investigator - McGill University
Robert Platt - Corresponding Applicant - McGill University
Claire Lefebvre - Collaborator - McGill University
Ke Meng - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Collaborator - McGill University
Michele Zappitelli - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Prescription of nephrotoxic medications; Intensity of prescription of nephrotoxic medications; Number of hospitalisations.
Description: Technical Summary
This is a cohort study of children 18 years of age or under, registered to the Clinical Practice Research Datalink (CPRD) between 1997 and 2016. There are two populations of interest: children with a history of hospital-associated acute kidney injury (AKI) and children with a diagnosis of chronic kidney disease (CKD). The objective of this study is to describe and compare primary care prescriptions of nephrotoxic medications (NTM) in children with versus without a history of AKI and in children with versus without a diagnosis of CKD. Unexposed children (without AKI or CKD) will be matched 4:1 on age, sex, CPRD practice and date of diagnosis or date of hospital discharge if the diagnosis was made during a hospitalization. We will look at the overall prevalence of NTM exposure and the number of different NTM prescribed within 1 year of AKI and within 5 years of CKD diagnosis respectively. Characteristics of exposed and unexposed children will be summarized and controlled for in multivariate analyses if they differ. Prevalence of 1 or more NTM prescriptions in incident AKI and CKD patients (95% CI) will be compared to matched, unexposed comparators using conditional logistic regression. The number of different NTM prescribed will be compared using Poisson regression.
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Using electronic health records to identify patients at high risk of severe liver disease — Andrew Hayward ...
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Using electronic health records to identify patients at high risk of severe liver disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-11
Organisations:
Andrew Hayward - Chief Investigator - University College London ( UCL )
Suvi Harmala - Corresponding Applicant - University College London ( UCL )
Alastair O'Brien - Collaborator - University College London ( UCL )
Laura Shallcross - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Cirrhosis of the liver
- Hepatic encephalopathy
- Variceal banding
- Portal hypertension
- Alcoholic Hepatitis
- Endoscopic sclerotherapy
- Oesophageal/Gastric varices
- Variceal bleeding
- Ascites
- Jaundice
- Acute on Chronic Liver Failure
- Spontaneous bacterial peritonitis
- Bacteraemia/sepsis
- Primary liver cancer
- Transjugular intrahepatic portosystemic shunt
- Liver transplant
- Hospitalisation for liver disease
- Liver disease-related deathDescription: Technical Summary
Cox proportional hazard regression will be used to identify predictors associated with liver disease outcomes in a cohort of patients with abnormal liver function blood tests (LFTs). By calculating the risk of developing liver disease outcomes according to a range of risk factors, we plan to build a predictive model to identify people at risk. Within the cohort, we will use self-controlled case series design to determine whether, after an episode of a common infectious illness (e.g. urinary tract infection), patients are temporarily at an increased risk of liver-related hospitalisation. Using conditional Poisson regression, we will estimate the incidence ratios (risk) of hospitalisations during each such risk period compared to hospitalisations during other time periods.
Using a case-control design, we aim to understand how to identify patients who, regardless of normal LFTs, develop cirrhosis. Cases will be those who develop cirrhosis despite prior normal LFT results. Controls will be patients without cirrhosis or abnormal LFTS (selected using Incidence Density Sampling). Multiple logistic regression will be used to identify predictors of cirrhosis in patients with normal LFTs. Finally, in a further case control analysis, we will identify risk factors for cirrhosis in those who have no LFT results.
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The adverse effects of tramadol — Samy Suissa ...
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The adverse effects of tramadol
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Christopher Filliter - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jacques LeLorier - Collaborator - Centre Hospitalier de l'Universite de Montreal
Josselin Cabaussel - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Linda Ou - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Ronald Grad - Collaborator - McGill University
Sarah Yoon - Collaborator - McGill University
YA-HUI YU - Collaborator - Georgia State UniversityOutcomes:
Myocardial infarction (primary)
- Ischaemic stroke
- Sudden cardiac death
- Unstable angina
- Arrhythmia
- All-cause mortality
- Cardiac revascularization
- Major haemorrhage
- Cardiovascular death
- Drug utilization
- Venous thromboembolismDescription: Technical Summary
With increasing concerns about opioid abuse and opioid-related deaths, the use of tramadol, a weak opioid with a low potential for abuse, has increased dramatically. Its mechanism of action involves binding to the mu-opioid receptor and inhibiting serotonin and norepinephrine reuptake. Because of its unique effect on serotonin, tramadol may lead to serotonin syndrome, a potentially life-threatening condition linked to hypertension, tachycardia, and cardiac arrhythmia. Conversely, serotonin reuptake inhibitors commonly lower platelet serotonin levels, potentially conferring cardioprotective abilities to tramadol. To date, there have been only three observational studies examining the cardiovascular effects of tramadol, all of which had major limitations. For additional insight, we will conduct a retrospective, population-based cohort study. In the CPRD linked to the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases, we will identify a study cohort of patients initiating tramadol or the active comparator codeine for non-cancer pain. Patients will be followed for myocardial infarction (MI; primary outcome), unstable angina, cardiac revascularization, major haemorrhage, ischaemic stroke, arrhythmia, venous thromboembolism (VTE), bleeding, and death (cardiovascular, sudden death, and all-cause). We will compare the risk of outcomes between tramadol and codeine users with marginal structural Cox models weighted by inverse probability of treatment.
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The impact of blood pressure thresholds on the risks of acute coronary syndrome (ACS) and stroke in non-cardiac surgery: a United Kingdom population-based cohort study — David Humes ...
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The impact of blood pressure thresholds on the risks of acute coronary syndrome (ACS) and stroke in non-cardiac surgery: a United Kingdom population-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-11
Organisations:
David Humes - Chief Investigator - University of Nottingham
Lu Ban - Corresponding Applicant - University of Nottingham
Puja Myles - Collaborator - CPRD
Rob Sanders - Collaborator - University Of Wisconsin MadisonOutcomes: none known
Description: Technical Summary
There are limited data to inform the perioperative care of patients with hypertension, including identification of blood pressure values that are associated with increased perioperative cardiovascular mortality and morbidity or optimal preoperative medication for reducing such risks. Therefore the aim of the study is to identify the effect of preoperative blood pressure and blood pressure variability (with and without antihypertensive medication prior to surgery) on the risks of postoperative cardiovascular morbidity (acute coronary syndrome (ACS) and stroke). We will use the CPRD-linked HES data to establish a cohort of adults aged ? 18 years with and without hypertension who underwent an elective non-cardiac surgery between 1st April 1997 and March 31st 2017. All patients will then be followed up from the date of surgery until they develop the outcome (ACS or stroke) or leave the study. We will extract data on preoperative blood pressure measurements and antihypertensive medications from primary care. Based on a cohort design we will calculate crude and adjusted hazard ratios using survival analysis. Adjustment will be carried out for age, gender, socioeconomic status, body mass index, smoking, pre-existing comorbidity and use of antihypertensive medications.
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The impact of polypharmacy on health outcomes in older patients: a retrospective cohort study using CPRD database. — Carlos Rodriguez Pascual ...
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The impact of polypharmacy on health outcomes in older patients: a retrospective cohort study using CPRD database.
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-22
Organisations:
Carlos Rodriguez Pascual - Chief Investigator - University Of Lincoln
Carlos Rodriguez Pascual - Corresponding Applicant - University Of Lincoln
Irene Boateng - Collaborator - University Of Lincoln
Paul Grassby - Collaborator - University Of Lincoln
Zahid Asghar - Collaborator - University Of LincolnOutcomes:
Hospitalisation; Adverse drug reactions; Mortality; Falls.
Description: Technical Summary
The main objective is to analyse the relationship between polypharmacy and one and five-year mortality, hospitalisations, adverse drug reactions and falls requiring hospital admission, adjusted for relevant confounders in patients aged 75 years and older. Secondary objectives are to analyse potentially inappropriate prescribing, and to study factors related with polypharmacy. These objectives will be achieved through a cross- sectional and retrospective cohort study. We will retrieve the number of drugs prescribed at the index record date. Polypharmacy will be defined by different cut-off points of 5, 8 and 11 prescribed drugs. Potentially inappropriate prescribing will be assessed with the Screening Tool Of Older People's Prescriptions (STOPP) criteria, and under-prescribing with the Screening Tool To Alert To Right Treatment (START) criteria. Study outcomes include mortality, urgent hospitalisations, adverse drug reactions (ADR) and falls requiring hospital admission. Confounders will include age, sex, previous falls, previous hospitalisations, comorbidities, cognitive impairment and the e-frailty index. Relationship between polypharmacy and outcomes will be summarised with odd ratios (OR) and hazard ratios (HR) with their 95% confidence interval obtained from logistic and Cox regression analysis adjusted for confounders. To avoid over-adjusting, we will include in models only those comorbidities not included in e-frailty index.
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Degree of serotonin reuptake inhibition of antidepressants and the risk of ischaemic stroke and myocardial infarction: a nested case control study — Samy Suissa ...
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Degree of serotonin reuptake inhibition of antidepressants and the risk of ischaemic stroke and myocardial infarction: a nested case control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-10-30
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Golsa Dehghan - Collaborator - McGill University
Jean-Francois Boivin - Collaborator - McGill UniversityOutcomes:
Incidence of ischaemic stroke; Incidence of myocardial infarction.
Description: Technical Summary
Serotonin can enhance platelet aggregation and induce vasoconstriction. Antidepressants such as the selective serotonin reuptake inhibitors may reduce thrombocyte serotonin levels. Therefore, they may inhibit platelet activation and eventually decrease thrombotic risk. Moreover, this risk may vary with the degree of serotonin inhibition of the antidepressant. Previous studies addressing this question had methodological shortcomings or were focussed on single entities of thrombotic disease. Therefore, the primary objective of this study is to determine whether the use of antidepressants strongly inhibiting serotonin reuptake is related to a decrease in the risk of ischaemic stroke and myocardial infarction using the Clinical Practice Research Datalink. For this purpose, we will assemble a cohort of patients, at least 18 years of age, newly treated with antidepressants between January 1, 1995 and June 30, 2014. Using a nested case-control approach, conditional logistic regression will be applied to compute odds ratios and 95% confidence intervals for each of the two outcomes associated with use of antidepressants with a high degree of serotonin reuptake inhibition, compared to antidepressants with a low degree of serotonin reuptake inhibition. Secondary analyses will assess the risk for each of the two outcomes according to duration of use of high affinity antidepressants.
Source
2017 - 09
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Quantifying the severity of chronic conditions in English Primary Care using the Clinical Practice Research Datalink — Evangelos Kontopantelis ...
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Quantifying the severity of chronic conditions in English Primary Care using the Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-12
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Salwa Zghebi - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
David Reeves - Collaborator - University of Manchester
Harm Van Marwijk - Collaborator - Brighton and Sussex Medical School
Mamas Mamas - Collaborator - Keele University
Martin Rutter - Collaborator - University of ManchesterOutcomes:
Develop cardiovascular disease (CVD)
- Hospitalisation
- All-cause death
- Cardiovascular and diabetes-related deaths
- Hospitalisation due to hypoglycaemiaDescription: Technical Summary
Background and Objective: Despite that there are numerous grades of clinical severity for most long-term conditions, analyses of routinely-collected electronic health records still tend to characterise these conditions in a simplistic binary (presence/absence) approach. We aim to longitudinally characterise two exemplar conditions, type 2 diabetes (T2DM) and coronary heart disease (CHD), to develop clinical decision algorithms that will grade the severity and respective health care needs of patients with T2DM or CHD using linked hospitalisation and mortality data.
Methods and Data Analysis: In this cohort study, data will be organised and analysed in annual data bins (2006-2016). Over time and by region, age-group, gender and socio-economic deprivation, we will: i) Generate algorithms to estimate severity grades for T2DM and CHD, using within-condition diagnoses (such as complications), comorbidities, treatments and referrals and validate using survival analysis models; ii) Assess the association between the severity scores and the outcomes: cardiovascular disease, hospitalisation and death (including cardiovascular mortality) iii) Describe the disease progression journey, time needed to progress through severity grades; iv) Using regression modelling techniques, estimate stratified prevalence rates for T2DM and CHD, for 2020 and 2030. We expect the developed algorithms and findings to inform both direct patient care and policy-making.
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with coronary artery disease (CAD), heart failure (HF), and CAD/HF — Jessica Jalbert ...
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with coronary artery disease (CAD), heart failure (HF), and CAD/HF
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-28
Organisations:
Jessica Jalbert - Chief Investigator - Regeneron Pharmaceuticals
Jessica Jalbert - Corresponding Applicant - Regeneron Pharmaceuticals
Alexander Cohen - Collaborator - King's College London (KCL)
Jean Baptiste Briere - Collaborator - Bayer AG
Jennifer Quint - Collaborator - Imperial College London
Julian Halcox - Collaborator - Swansea UniversityOutcomes: none known
Description: Technical Summary
This is a cohort study with the overall objective of gaining a better understanding of the epidemiology, disease course, health resource utilisation (HRU), and treatment patterns of real-world patients with coronary artery disease (CAD), chronic heart failure (CHF), and CAD/CHF. The specific aims of the study are:
⢠To estimate the incidence and prevalence of CAD, CHF, and CAD/CHF
⢠To describe demographic and clinical characteristics of patients with CAD, CHF, and CAD/CHF
⢠To estimate the risk/incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CAD, CHF, and CAD/CHF
⢠To describe HRU related to CAD and CHF complications among patients with CAD, CHF and CAD/CHF
⢠To describe treatment patterns, with a focus on standard of care, among patients with CAD, CHF, and CAD/CHF
⢠To estimate the risk/incidence of complications, compare the risk of complications, describe HRU related to CAD and CHF complications, and describe treatment patterns among subgroups of patients with CAD, CHF, and CAD/CHF defined by demographics, medical history, prior procedures, medication use, and risk scores
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Effect of major common infections on the incidence of post-stroke dementia: a cohort study using the UK Clinical Practice Research Datalink — Charlotte Warren...
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Effect of major common infections on the incidence of post-stroke dementia: a cohort study using the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-12
Organisations:
Charlotte Warren-Gash - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Charlotte Warren-Gash - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Morton - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Neil Pearce - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Early post-stroke dementia (3 months to 1 year); Later post-stroke dementia (1 to 5 years).
Description: Technical Summary
Cognitive problems contribute substantially to the disability experienced after stroke and result in a major health and societal burden. Both short- and long-term cognitive changes occur after stroke, but reasons for the development of post-stroke dementia remain unclear. Infections are hypothesised to play a role, perhaps acting through systemic inflammatory pathways that trigger a disordered microglial response in the aged brain. Here we aim to investigate the association between common serious infections and incident dementia in a population cohort of adult stroke survivors using electronic health records (EHR). Using routinely collected EHR data will increase power and generalisability of findings as well as overcoming some methodological difficulties that may hamper traditional cohort studies of post-stroke dementia such as ascertainment bias. We will carry out a multivariable Cox regression analysis to compare incidence rates of post-stroke dementia among stroke survivors exposed and unexposed to infections in time periods after stroke, controlling for potential socio-demographic and clinical confounding factors. In secondary analyses, we will investigate the effect of site, frequency, severity and timing of infections on dementia outcomes. Better understanding of these relationships will help to inform the development and targeting of interventions to prevent and treat infections after stroke and thereby preserve cognitive function.
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Drug Utilisation Patterns and Healthcare Resource Use in Patients With Neurogenic Bladder (NGB): A descriptive study using electronic health records from the UK — Margarita Landeira ...
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Drug Utilisation Patterns and Healthcare Resource Use in Patients With Neurogenic Bladder (NGB): A descriptive study using electronic health records from the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-28
Organisations:
Margarita Landeira - Chief Investigator - Astellas Pharma Europe Ltd. - UK
Ashley Jaggi - Corresponding Applicant - Astellas Pharmaceuticals
Ashley Jaggi - Collaborator - Astellas Pharmaceuticals
Francis Fatoye - Collaborator - Manchester Metropolitan University
Laurie Cooper - Collaborator - Manchester Metropolitan University
Marcus Drake - Collaborator - University of Bristol
Vasileios Giagos - Collaborator - Manchester Metropolitan UniversityOutcomes: none known
Description: Technical Summary
There is considerable heterogeneity in urinary symptoms between Neurogenic Bladder (NGB) patients due to the differences in underlying neurological conditions, site of neurological injury and degree of disability. This compounds the availability of a single optimal medical therapy. It is currently not clear how patients are managed in real world United Kingdom (UK) clinical practice. In addition, the healthcare burden remains undescribed in an English population. Characterising the NGB population is important for devising more rational and cost-effective management strategies, which will facilitate the safe and effective use of medications. This study will also aid in decisions around the adequate allocation of healthcare resources.
Therefore, the main objective of this descriptive study using the Clinical Practice Research Datalink (CPRD) GOLD is to address the epidemiology and characterise the drug utilisation patterns in NGB patients identified between 1st January 2004 and 31st December 2016. The secondary objective using CPRD data linkage with Hospital Episode Statistics (HES) focuses on providing useful estimates of healthcare resource utilisation, including number of GP visits, procedures and operations performed, secondary care referrals and hospitalisations.
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the safety and effectiveness of direct oral anticoagulants antagonists in conditions that elevate drug concentrations — Ilan Matok ...
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the safety and effectiveness of direct oral anticoagulants antagonists in conditions that elevate drug concentrations
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-18
Organisations:
Ilan Matok - Chief Investigator - The Hebrew University of Jerusalem
Ilan Matok - Corresponding Applicant - The Hebrew University of Jerusalem
Amichai Perlman - Collaborator - The Hebrew University of Jerusalem
Bruria Raccah - Collaborator - The Hebrew University of Jerusalem
Donna R. Zwas - Collaborator - The Hebrew University of JerusalemOutcomes:
The primary outcome for inducers will be stroke and systemic embolism. The primary outcome for inhibitors will be major bleeding.
Description: Technical Summary
Primary objective: to assess the safety and effectiveness of direct oral anticoagulants antagonists in conditions that elevates drug concentrations: renal failure, female gender and specific drugs.
Methods: This study will use the CPRD database, the HES and the ONS mortality data. The study has been designed as cohort study on patients with a diagnosis of AF. The index date will be defined as the first prescription to anticoagulant (DOACS/VKA). The cohort will be restricted to those eligible for linkage with HES and ONS mortality data. Patients will be followed from index date until the earliest of the respective outcome of interest (stroke, systemic embolism, intracranial bleeding, death from any cause, gastrointestinal bleeding, traumatic intracranial bleeding, major bleeding and non-major clinically relevant bleeding), transfer out of the practice or last data collection. Special consideration will be given to participants with previous stroke, and their data will undergo a separate analysis.
Cohort study data analysis: time-varying approach.Cox proportional hazard models.
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Utility and performance of prognostic algorithms for cardiovascular disease in type 2 diabetes patients. — Amand Floriaan Schmidt ...
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Utility and performance of prognostic algorithms for cardiovascular disease in type 2 diabetes patients.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-21
Organisations:
Amand Floriaan Schmidt - Chief Investigator - University College London ( UCL )
Amand Floriaan Schmidt - Corresponding Applicant - University College London ( UCL )
Bob Wilffert - Collaborator - University of Groningen
Eelko Hak - Collaborator - University of Groningen
Folkert Asselbergs - Collaborator - University College London ( UCL )
Katarzyna Dziopa - Collaborator - University College London ( UCL )
Kenan Direk - Collaborator - University College London ( UCL )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Mihaela van der Schaar - Collaborator - University of Oxford
Nishi Chaturvedi - Collaborator - University College London ( UCL )
Riyaz Patel - Collaborator - Barts Health and UCLH NHS TrustsOutcomes:
The primary outcomes are cardiovascular disease (CVD) and the individual CVD elements. All-cause mortality can be considered a secondary outcome as it plays an important role as a competing risk.
- Cardiovascular disease
- Stroke
- All-cause mortality
- Coronary heart disease
- Myocardial infarction
- Heart Failure
- AnginaDescription: Technical Summary
Objective:
To compare performance of existing cardiovascular disease (CVD) prediction rules in type 2 diabetes (T2DM) patients and derive novel rules accommodating differences between patient subgroups, and type of CVD.Methods and data analysis:
For the first time we will use a single dataset to externally validate existing CVD prognostic rules in T2DM patients on: overall performance, discrimination, calibration and risk classification ( cut-offs <5%, 5%-20% and >20%). Performance will be stratified on: calendar time periods (per year and clinically relevant periods), duration of T2DM diagnosis (</=1,3,5, >/=8 years), history of coronary heart disease (CHD) or stroke, type of CVD, ethnicity, geographical location (as proxy for differences in case-mix).Novel prediction rules will be derived by extending the Cox proportional hazard model to account for competing risks using the Fine and Grey methodology (Fine & Gray, 1999), allowing for joint prediction of individual CVD elements (e.g., stroke, MI, heart failure [HF]), as well as correcting for risk over-estimation due to all-cause mortality (Lau, Cole, & Gange, 2009). To further increase applicability, a novel nonparametric multivariate method (Andreas C. Damianou, 2013) will be used which can flexibly account for interactions between patient characteristics, and changes in prognostic ability over time (i.e., disease duration).
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National patterns in anti-asthmatic treatment in general practice: a descriptive study using data from the Clinical Practice Research Datalink. — Alicia Gayle ...
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National patterns in anti-asthmatic treatment in general practice: a descriptive study using data from the Clinical Practice Research Datalink.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-17
Organisations:
Alicia Gayle - Chief Investigator - Imperial College London
Alicia Gayle - Corresponding Applicant - Imperial College London
Florent Guelfucci - Collaborator - Creativ-Ceutical
Gavin Chiu - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Nikco Hau - Collaborator - Boehringer-Ingelheim Germany
Vincent Mak - Collaborator - Imperial College LondonOutcomes:
Patterns of use of chronic medication for patients.
Description: Technical Summary
This study is a non-interventional cohort study using existing data provided by the Clinical Practice Research Datalink (CPRD), to gain a qualitative description of asthma prescribing patterns in the United Kingdom. Current practice in comparison to the recommended guidelines has yet to be explored. The main objective of this study is to describe the treatment patterns and transitions between each asthma step in relation to recommended guidelines. Comorbidities and demographic information will be described for the groups of patients at different steps and summary statistics and measures of central tendency will be used to describe the cohort. The results from this study will be used to support the scientific understanding of how therapy guidelines are adhered to in primary care.
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Clinical characteristics and healthcare resource utilization of Spinal Muscular Atrophy patients in the United Kingdom — Megan Teynor ...
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Clinical characteristics and healthcare resource utilization of Spinal Muscular Atrophy patients in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-18
Organisations:
Megan Teynor - Chief Investigator - Biogen
Megan Teynor - Corresponding Applicant - Biogen
Andy Surinach - Collaborator - Genesis Research LLC
Frank Corvino - Collaborator - Genesis Research LLCOutcomes: none known
Description: Technical Summary
This is a retrospective longitudinal cohort study examining SMA patients enrolled in CPRD. Patients with at least one diagnosis of SMA between January 1, 1987 to June 1, 2016 from up-to-date practices will be extracted from CPRD Gold. We will describe the most common associated comorbidities and treatments that occur prior to being diagnosed with SMA as well as those that are most common after SMA onset. For patients that are able to be linked to the ONS Mortality Data, both the Inpatient and Outpatient Hospital Episode Statistics, and HES Accident and Emergency datasets additional outcomes will be explored. Using the HES data we will describe NHS resource utilisation, costs, and outcomes among patients with SMA. ONS Mortality data will be used to describe the survival of SMA patients. The ability to discern SMA subtypes based on diagnostic coding, healthcare encounters, and age at onset will be examined. Patients will be studied from the earliest SMA diagnosis through the available longitudinal time frame.
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Predicting medication adherence in patients with resistant hypertension — Sarah...
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Predicting medication adherence in patients with resistant hypertension
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-18
Organisations:
Sarah-Jo Sinnott - Chief Investigator - Not from an Organisation
Sarah-Jo Sinnott - Corresponding Applicant - Not from an Organisation
Alice Dawson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
There are no clinical outcomes in this study, rather the outcome is adherence to drug therapy.
Description: Technical Summary
Individuals who have uncontrolled hypertension on three anti-hypertensive drugs often require the addition of a fourth anti-hypertensive drug. The benefit of this is centred on lowering blood pressure, but the risk is adding to the patientÂs medication burden and increasing potential for drug-drug interactions. Poor medication adherence is a potential cause of Resistant Hypertension (uncontrolled hypertension on three or more anti-hypertensive drugs), but it is unknown how adherent patients are to their three drug regimens before a fourth drug is added. In a population of individuals who initiate four anti-hypertensive drugs, we will calculate the proportion of individuals who were adherent to their three drug regimen before addition of fourth agent. Our proxy measure of adherence will rely on prescribing data in CPRD and will be calculated as the average proportion of days covered for all drugs in the year prior to initiating the fourth drug. This will be a descriptive analysis. We will also assess how adherence to three drugs predicts adherence to four drugs using multivariable logistic regression. Lastly, we will assess the patient level factors that are associated with adherence to anti-hypertensive drugs, both in three drug and in four drug regimens using multivariable logistic regression.
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The effectiveness of CVD preventative treatment in a multi-morbid population — Rachel Denholm ...
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The effectiveness of CVD preventative treatment in a multi-morbid population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-18
Organisations:
Rachel Denholm - Chief Investigator - University of Bristol
Rachel Denholm - Corresponding Applicant - University of Bristol
John Macleod - Collaborator - University of Bristol
Neil Davies - Collaborator - University of Bristol
Rachael Hughes - Collaborator - University of Bristol
Richard Morris - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of BristolOutcomes: none known
Description: Technical Summary
GPs are encouraged to aggressively reduce cardiovascular risk in their patients through prescribing primary and secondary preventative therapeutic treatments. Evidence of the benefits from such risk-reduction strategies from RCTs is strong. However, RCTs are typically conducted among relatively young, affluent participants, who are comparatively healthy with under-representation of other health conditions. It is not clear whether treatment effects demonstrated in RCTs generalise to a multi-morbid population.
The study will use data from adult patients who have been diagnosed with 2 or more conditions and are at risk of CVD from between 2004 and 2014. The primary outcomes will be an incident CVD event or death, and any death as a secondary outcome. Our key exposure with be a prescription of a CVD preventative medication, including statins, anti-hypertensives, dual antiplatelet therapy and anti-diabetic agents. Survival analysis will be used to compare the CVD event/mortality rates between patients prescribed CVD preventative medication, with those not. Adjustments will be made for GP practice, age, sex, socio-economic status, multi-morbidities, other medication, BMI and smoking status.
Findings from this study have the potential to improve the treatment and management of a growing proportion of the general population, potentially preventing further morbidity in a high risk population.
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Selective-recruitment designs for prospective observational studies of cardiovascular diseases using primary care electronic health records. — Spiros Denaxas ...
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Selective-recruitment designs for prospective observational studies of cardiovascular diseases using primary care electronic health records.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-10
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Sera Aylin Cakiroglu - Corresponding Applicant - Francis Crick Instituite
Catey Bunce - Collaborator - King's College London (KCL)
James Barrett - Collaborator - King's College London (KCL)
Nicholas Luscombe - Collaborator - UCL HospitalOutcomes: none known
Description: Technical Summary
The aim of our proposed research is to develop and evaluate statistical approaches for selecting informative cohorts from within a large database of patient electron health records for the purposes of a prospective observational study. Informativeness depends on an individuals covariates. The statistical measure of entropy is used to quantify how much statistical information an individual is expected to provide on the study. More informative individuals have a higher probability of being selectively-recruited onto the study.
Using stable coronary artery disease as a case study, we will apply and evaluate selective-recruitment and randomised-recruitment designs on numerically simulated observational studies using existing linked electronic health records from primary care (CPRD) and hospital care (Hospital Episode Statistics). The required sample size, cost-effectiveness, and duration of both designs will be compared in order to assess the potential advantages that electronic health records can offer. The purpose of our research is solely to evaluate statistical methods via numerically simulated observational studies.
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The effect of renin-angiotensin system inhibitors on haemoglobin — Laurie Tomlinson ...
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The effect of renin-angiotensin system inhibitors on haemoglobin
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-24
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
George Greenhall - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Collaborator - University of Tsukuba
Rosalynd Johnston - Collaborator - NHSOutcomes: none known
Description: Technical Summary
We aim to investigate the association between ACEI/ARBs and reduction in haemoglobin. We will identify a cohort of new-users of ACEI/ARBs and calcium channel blockers (CCB) with haemoglobin levels recorded both before (up to one year) and after (up to six months) drug initiation. We will calculate and compare mean haemoglobin change following ACEI/ARB or CCB initiation. We will use logistic regression to identify risk factors associated with a fall in haemoglobin after drug initiation. Risk factors considered will include: age, sex, ACEI/ARB or CCB use, chronic comorbidities (diabetes mellitus, cardiac failure, chronic kidney disease, hypertension, ischaemic heart disease, myeloproliferative syndromes, and chronic lung disease), pre-initiation haemoglobin level, past history of gastrointestinal bleeding, medications and lifestyle factors (smoking, alcohol intake, and body mass index). We will also: (1) Investigate whether baseline haemoglobin level and chronic kidney disease modify the effect of ACEI/ARBs on haemoglobin; (2) Compare change in haemoglobin between new users of ACEIs and ARBs by comparing mean change in haemoglobin and calculating the odds of a fall in haemoglobin in each group; and (3) Compare the proportion of ACEI, ARB and CCB users with records indicating post-initiation bone marrow suppression.
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Real World Effects of Medications for Chronic Obstructive Pulmonary Disease — Ian Douglas ...
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Real World Effects of Medications for Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-05
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
James Carpenter - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Lesley Wise - Collaborator - Wise Pharmacovigilance and Risk Management Ltd
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sebastian Schneeweiss - Collaborator - Aetion, IncOutcomes:
COPD exacerbation
- Mortality
- Pneumonia
- Time to treatment change (COPD medication)Description: Technical Summary
We will use CPRD data linked with HES to select patients with COPD. We will then validate the use of CPRD data for estimating COPD treatment effects by replicating findings of the landmark COPD trial called TORCH. Using individual patient data from TORCH, we will assemble a cohort in the CPRD with similar characteristics to TORCH participants and test whether observational data can generate comparable results to trials, using cohort methodology with propensity score techniques to adjust for potential confounding. Next we will use the methodological template we have developed to determine risks and benefits of COPD treatments in people excluded from TORCH. Outcomes are pneumonia, COPD exacerbation, mortality and time to treatment change. Groups to be studied include the elderly (>80 years), people with substantial comorbidity, people with and without underlying cardiovascular disease and people with mild COPD. Comparisons will be made according to COPD treatment status for; rate of COPD exacerbation, pneumonia and mortality over 3 years. For exacerbations, a negative binomial model will be used, with the number of exacerbations as the outcome and the log of treated time as an offset variable. Time to mortality and first pneumonia will be analysed using Cox proportional hazards regression.
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Handling missing covariate data and changes in exposure status: — Ian Douglas ...
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Handling missing covariate data and changes in exposure status:
Datasets:GP data, MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-05
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Corresponding Applicant - GSK
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Tazare - Collaborator - GSK
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Myocardial Infarction
- All-cause mortality
- Myocardial Infarction or all-cause mortalityDescription: Technical Summary
A recent CPRD cohort study suggested between person confounding remained a problem when investigating a potential interaction between PPIs and clopidogrel, as biologically implausible harmful associations were observed. Results from a self-controlled case series (SCCS) on the same data showed no increased risk of MI with PPI exposure and were thought to be more reliable as, in this analysis, fixed between person confounding is removed by design. SCCS limitations mean a more general solution is needed.
We identified treatment (PPI) switching and exclusion of potentially important confounders due to missing data as key issues.
To investigate treatment switching, we would perform "intent-to-treat", "per-protocol" and "as-treated" analyses using Cox models, incorporating probability weights accounting for participant differences between those who did and didn't change exposure status during follow-up. We will extend this idea by using more complex approaches such as marginal structural models, splitting data into, for example, 3-month intervals.
For missing data, we would initially incorporate information from confounders, previously omitted using missing categories approaches and then proceed to multiple imputation based analyses in the different analysis settings outlined above.
Finally, we would investigate methods to incorporate both issues.
Through this work we seek only to improve methodological approaches in future studies, not answer additional clinical questions.
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Progression of chronic kidney disease and the risk of severe infection, venous thromboembolism and major adverse cardiovascular event in patients with and without diabetes — Craig Currie ...
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Progression of chronic kidney disease and the risk of severe infection, venous thromboembolism and major adverse cardiovascular event in patients with and without diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-18
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Laura Scott - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Meena Jain - Collaborator - Napp Pharmaceutical Group
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
This study aims to predict outcomes such as end stage renal disease (ESRD), infection and major adverse cardiac events (MACE) in patients with chronic kidney disease (CKD) in three different cohorts; non-diabetes, diabetes type 1 and diabetes type 2. The objectives are to identify a population of patients with CKD using Read codes and ICD-10 codes and describe their progression to one or more of the three endpoints: MACE, infection or ESRD.
Adjusted incidence rates and 95% confidence intervals for all-cause and cause-specific infections will be calculated for eGFR category using Poisson regression and presented as incidence rate ratios (IRR) with eGFR >90ml/min/1.73m2/year as the reference. Time-dependent Cox-proportional hazard models will be used to estimate risk and account for potentially confounding factors, incorporating eGFR and albuminuria staging, diabetes status, prior co-morbid events and baseline characteristics and therapies. Other regressions models will be run as a sensitivity analysis, adjusting for covariates at baseline.
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Association between the prevalence of cardiovascular risk factors and new use of testosterone — Carlos Martinez ...
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Association between the prevalence of cardiovascular risk factors and new use of testosterone
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-28
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)Outcomes:
Post-stroke dementia/cognitive impairment.
Description: Technical Summary
This study aims to describe the association between the prevalence of cardiovascular risk factors and new use of testosterone in a population-based nested case-control study in a cohort of men with a GP consultation between January 2001 and the latest data available in the CPRD-HES link. Patients with an initial testosterone prescription at a GP consultation will be defined as cases. Patients matched on year of birth, history of hypogonadism and on the day of initial testosterone prescription (index day) but without a history of testosterone prescription use as of the index day will be selected as controls. Potential cardiovascular risk factors of interest will include high BMI, smoking, hypercholesterolemia, history of stroke/transient ischaemic attack, atrial fibrillation, myocardial infarction, ischaemic heart disease, heart failure, hypertension and diabetes. Adjusted odds ratios of the association between cardiovascular risk factors and initiation of testosterone therapy will be estimated using conditional logistic regression for matched case-control data.
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Risk factors for biliary tract cancer in the United Kingdom Clinical Practice Research Datalink Database — Jill Koshiol ...
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Risk factors for biliary tract cancer in the United Kingdom Clinical Practice Research Datalink Database
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-28
Organisations:
Jill Koshiol - Chief Investigator - National Cancer Institute ( NCI )
Jill Koshiol - Corresponding Applicant - National Cancer Institute ( NCI )
Bin Zhu - Collaborator - National Cancer Institute ( NCI )
Lesley Anderson - Collaborator - Queen's University Belfast
Sarah Jackson - Collaborator - National Cancer Institute ( NCI )
Zhiwei Liu - Collaborator - National Cancer Institute ( NCI )Outcomes: none known
Description: Technical Summary
We propose to describe risk factors for biliary tract cancers using the UK Clinical Practice Research Datalink database (CPRD). In particular, we plan to evaluate the association of anti-inflammatory drugs with risk of biliary tract cancers. We propose a case-cohort approach, wherein we include all biliary tract cancer cases within the CPRD and a random sample of one million CPRD patients. This approach has been successful for past CPRD projects and would facilitate evaluation of time-varying exposures, such as anti-inflammatory drug use. We will use Cox proportional hazard models to calculate by hazard ratios (HRs) and 95% confidence intervals (CI) for anti-inflammatory drugs and type of biliary tract cancer.
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Treatment with DPP-4 inhibitors, adherence to Summary of Product Characteristics and therapy adjustment. — Chris D Poole ...
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Treatment with DPP-4 inhibitors, adherence to Summary of Product Characteristics and therapy adjustment.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-12
Organisations:
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Brendan Barrett - Collaborator - Boehringer-Ingelheim - UK
Dionysios Spanopoulos - Collaborator - Eli Lilly & Co - UK
Michael Busse - Collaborator - Boehringer-Ingelheim - UK
Toni Roman - Collaborator - Eli Lilly & Co - UKOutcomes:
Counts and percentages of patients initiating on a higher than the recommended DPP-4i dose for level of renal function according to the SmPCs (Creatinine Clearance), on
country level and per CPRD defined region: Counts and percentages of patients initiating on a lower than the recommended DPP-4i dose according to the SmPCs.
Amongst patients who initiate on a higher than the recommended dose for renal function according to the SmPCs (Creatinine Clearance level): Counts and percentages of patients who have their dose adjusted or switched (time to event analysis).
Amongst patients who initiate on the high dose of a DPP-4 inhibitor in accordance with the level of renal function as per SmPCs: Counts and percentage of patients who have their therapy changed or switched when their renal function is reduced to a creatinine clearance level according to which therapy switch/dose adjustment is required.Description: Technical Summary
DPP-4i drug class is indicated for the glycaemic control in patients with Type 2 Diabetes Mellitus (T2DM). According to the Summary of Product Characteristics (SmPC), Saxagiptin, Sitagliptin, Alogliptin and Vildagliptin require dose adjustments according to patients' renal function as expressed by different Creatinine Clearance thresholds. The proposed study aims to examine a number of objectives around compliance to SmPCs for DPP4-is in relation to renal function. Cross-sectional analyses will generate descriptive statistics to characterise the extent to which T2DM patients are initiating on a higher than the recommended dose of a DPP-4i according to SmPCs. Higher than the recommended prescription patterns will also be explored in regional level. Moreover, descriptive statistics will be generated to characterise the extent to which patients with good renal function are initiating on the lower doses of a DPP-4i. Additional outcomes will be explored in retrospective analyses; in particular, time to event analyses will be conducted to characterise the extent of dose adjustment and appropriate therapy switching among T2DM patients who initiate on a higher than the recommended DPP-4i dose. Separate retrospective analysis characterise the extent to which deterioration of renal function overtime is associated with therapy change or DPP4-i dose adjustment.
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Cardiovascular Outcomes and Mortality in Cardio-Renal-Metabolic Disease Progression in Type 2 Diabetes Mellitus Patients within the United Kingdom — Enrico Repetto ...
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Cardiovascular Outcomes and Mortality in Cardio-Renal-Metabolic Disease Progression in Type 2 Diabetes Mellitus Patients within the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-28
Organisations:
Enrico Repetto - Chief Investigator - Astra Zeneca Inc - USA
Phillip Hunt - Corresponding Applicant - Astra Zeneca Inc - USA
Goran Gannendahl - Collaborator - Astra Zeneca R&D Molndal Sweden
Hungta Chen - Collaborator - Astra Zeneca Inc - USA
Rene Schade - Collaborator - ICON plc
Robert LoCasale - Collaborator - Astra Zeneca Inc - USA
Sharon MacLachlan - Collaborator - Evidera, IncOutcomes:
MACE (MI, Stroke, CV Death); MACE+ (plus HF, coronary revascularization); All-Cause Mortality.
Description: Technical Summary
Several cardio-renal-metabolic (CaReMe) conditions, such as hypertension (HTN), hyperlipidemia, chronic kidney disease (CKD), atherosclerotic vascular disease (ASCVD), gout, liver fibrosis and heart failure (HF) are independently associated with worse prognosis in patients with T2DM. The prevalence of these comorbidities, their unique combinations and patterns of appearance over time, and subsequent association with major adverse cardiovascular events (MACE), MACE plus HF or coronary revascularization (MACE+), and all-cause mortality will be described in a newly diagnosed, contemporary T2D cohort. This cohort study will utilize the Clinical Practice Research Datalink (CPRD) database linked to the Hospital Episodes Statistics (HES) and ONS Mortality data. The study period will begin on January 1, 2010 and will end on March 31, 2016. Each of the clinical outcomes of interest will be described separately. Event rates and 95% CIs will be reported as both incidence risks and observation time-adjusted incidence rates and will be stratified by the commonly occurring disease sequences occurring before and after diagnosis of T2DM. Survival distributions utilizing Kaplan-Meir method will describe time to CaReMe disease progression, time to MACE, time to MACE+ and time to all-cause mortality. Knowing how the combinations and the sequences of diseases affect cardiovascular risk and mortality may help doctors provide better treatment to patients with these diseases.
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Developing a Clinical Decision Support Tool for the Early Diagnosis of Malignant Tumours of the Pancreas — Stephen Pereira ...
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Developing a Clinical Decision Support Tool for the Early Diagnosis of Malignant Tumours of the Pancreas
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-09-28
Organisations:
Stephen Pereira - Chief Investigator - University College London ( UCL )
Stephen Pereira - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Harry Martin - Collaborator - University College London ( UCL )
Margaret (Geri) Keane - Collaborator - University College London ( UCL )
Peter Labib - Collaborator - University College London ( UCL )
Rebecca White - Collaborator - University College London ( UCL )
Shahida Islam - Collaborator - University College London ( UCL )Outcomes:
Primary health outcomes
- Diagnosis of a pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumour or biliary tract cancerSecondary health outcomes
- Trends in incidences of the three different cancer types over the study period
- Overall survival of patients after they have been diagnosed with a pancreatic or biliary tract cancer
- How patients use health care resources (e.g. GP or hospital attendances) before they are diagnosed with a cancer arising from within the pancreasDescription: Technical Summary
Objective: To create a clinical decision support tool to help doctors determine the risk that a patient with a particular set of symptoms and risk factors has a cancer within the pancreas, to assist in deciding whether or not to refer a patient for further investigation. Methods: The anonymised records of ten million patients in the Clinical Practice Research Datalink (CPRD) dataset from 2000 - 2016 will be analysed. Patients with a cancer within the pancreas (pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumours, or biliary tract cancers) diagnosed between 01/01/2001 and 31/12/2015 will be compared to patients without cancer to determine the likelihood that a patient presenting with a particular group of symptoms and risk factors has one of these cancers. Data analysis: Descriptive statistics will be used to determine the changing incidences of the three cancer types over the study period. Multivariable regression analysis will examine the associations between the three cancer types and age, gender and level of deprivation, as well as determining whether survival from these cancers has changed in the last 15 years. Regression models, cluster and factor analyses will be used to develop an algorithm to estimate the risk of pancreatic cancer based on an individual patient's symptoms and risk factors.
Source
2017 - 08
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with coronary artery disease (CAD), peripheral artery disease (PAD), and CAD/PAD — Jessica Jalbert ...
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Epidemiology, outcomes, treatment patterns, and health resource utilization among English patients with coronary artery disease (CAD), peripheral artery disease (PAD), and CAD/PAD
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-28
Organisations:
Jessica Jalbert - Chief Investigator - Regeneron Pharmaceuticals
Jessica Jalbert - Corresponding Applicant - Regeneron Pharmaceuticals
Alexander Cohen - Collaborator - King's College London (KCL)
Jean Baptiste Briere - Collaborator - Bayer AG
Jennifer Quint - Collaborator - Imperial College London
Julian Halcox - Collaborator - Swansea UniversityOutcomes:
Incidence and prevalence of coronary artery disease (CAD), peripheral artery disease (PAD), and CAD and PAD
⢠Risk and incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CAD, PAD, and CAD and PAD
⢠Health resource utilisation (HRU) related to CAD and PAD complications in patients with CAD, PAD, and CAD and PAD
⢠Treatment patterns (with a focus on standard of care) in patients with CAD, PAD, and CAD and PAD
⢠Risk/incidence of complications for CAD and PAD, HRU for CAD and Pad complications, and treatment patterns for key sub-populations of patients with CAD, PAD, and CAD and PADDescription: Technical Summary
This is a cohort study with the overall objective of gaining a better understanding of the epidemiology, disease course, health resource utilisation (HRU), and treatment patterns of real-world patients with coronary artery disease (CAD), peripheral artery disease (PAD), and CAD/PAD. The specific aims of the study are:
⢠To estimate the incidence and prevalence of CAD, PAD, and CAD/PAD
⢠To describe demographic and clinical characteristics of patients with CAD, PAD, and CAD/PAD
⢠To estimate the risk/incidence of complications (e.g. major cardiovascular events, bleeding) among patients with CAD, PAD, and CAD/PAD
⢠To describe HRU related to CAD and PAD complications among patients with CAD, PAD and CAD/PAD
⢠To describe treatment patterns, with a focus on standard of care, among patients with CAD, PAD, and CAD/PAD
⢠To estimate the risk/incidence of complications, compare the risk of complications, describe HRU related to CAD and PAD complications, and describe treatment patterns among subgroups of patients with CAD, PAD, and CAD/PAD defined by demographics, medical history, prior procedures, medication use, and risk scoresThe study will be undertaken utilizing linked data within the Clinical Practice Research Database and Hospital Episode Statistics database. The study time frame will be 1 January 2010 to the most recent data available.
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Risk of colorectal adenoma after obesity surgery — Mark Hull ...
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Risk of colorectal adenoma after obesity surgery
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-07
Organisations:
Mark Hull - Chief Investigator - University of Leeds
Ariadni Aravani - Corresponding Applicant - University of Leeds
Amy Downing - Collaborator - University of Leeds
Eva Morris - Collaborator - University of Leeds
Mar Pujades Rodriguez - Collaborator - University of LeedsOutcomes:
Time to colorectal adenoma
- Colorectal adenomaSecondary outcomes will be:
- Colorectal cancer
- Breast cancer
- Cancer of oesophagus
- Kidney cancer
- Endometrial cancer
- Ovarian cancer
- Cancer of the pancreas
- Upper stomach cancer
- MyelomaDescription: Technical Summary
There is inconclusive evidence of an association between obesity surgery and long-term colorectal cancer (CRC) risk from separate studies in Scandinavia and England, which is partly related to the small number of CRC cases and short follow-up time after obesity surgery. The benign colorectal adenoma (natural history for development 1-3 years) is a recognised biomarker of CRC risk (Kinzler and Vogelstein, 1996, O'Brien et al., 1990) allowing a shorter follow-up period in a cohort study. We propose to use CPRD in order to explore colorectal adenoma risk after obesity surgery. This will be achieved through: 1) Initial non-parametric estimation of the probability of adenoma development in obese patients who had bariatric surgery and for obese patients who did not have bariatric surgery; 2) risk-adjusted survival analysis investigating the time from obesity surgery to adenoma; and 3) risk-adjusted binary analysis of adenoma development (yes/no) for obese patients with/without obesity surgery. If colorectal adenoma risk is elevated after obesity surgery, it will make the case for a study of the effectiveness of colonoscopic surveillance after obesity surgery for reduction in CRC risk. We will also examine the association between obesity surgery and obesity-related cancers (e.g. CRC, esophagus, endometrium or kidney).
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Dipeptidyl deptidase-4 inhibitors and the incidence of inflammatory bowel disease among patients with type 2 diabetes. — Samy Suissa ...
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Dipeptidyl deptidase-4 inhibitors and the incidence of inflammatory bowel disease among patients with type 2 diabetes.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-28
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Alain Bitton - Collaborator - McGill University
Antonios Douros - Collaborator - McGill University
Christel Renoux - Collaborator - McGill University
Devin Abrahami - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Inflammatory bowel disease (IBD) overall; Crohn's disease; Ulcerative colitis.
Description: Technical Summary
DPP-4 inhibitors are incretin-based drugs that are now commonly used to treat type 2 diabetes. However, in addition to its role in glucose metabolism, there is evidence that the DPP-4 enzyme (also known as CD26) may play a role in IBD, although its specific role is not well understood. On the one hand, this enzyme has been shown to inhibit T-cell proliferation and cytokine production, while on the other, studies have reported decreased levels of the DPP-4 enzyme in serum of IBD patients, which are inversely associated with disease severity; the latter supports a possible deleterious role of DPP-4 in IBD. To address this question, we will assemble a cohort of approximately 130,000 patients newly-treated with antidiabetic drugs between 2007 and 2016, with follow up until 2017. Use of DPP-4 inhibitors will be modelled as a time-varying variable, allowing for a 6-month lag period for latency. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of IBD associated with use of DPP-4 inhibitors, compared with use of all other antidiabetic drugs. Secondary analyses will assess whether risk varies by duration of use, and by type of IBD (Crohn's disease and ulcerative colitis).
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Restriction and comorbidity matching to control for confounding in a study of 5 alpha reductase Inhibitors (5ARIs) and risk of Venous Thromboembolism (VTE) in male Benign Prostatic Hyperplasia (BPH) patients. — Susan Jick ...
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Restriction and comorbidity matching to control for confounding in a study of 5 alpha reductase Inhibitors (5ARIs) and risk of Venous Thromboembolism (VTE) in male Benign Prostatic Hyperplasia (BPH) patients.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-07
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Lade Ayodele - Corresponding Applicant - Decision Resources GroupOutcomes:
Incident Venous Thromboembolism.
Description: Technical Summary
Venous thromboembolism (VTE) continues to pose an important disease burden, however a lot remains unknown about the risk factors that cause it. In recent years, more attention has been focused on medications that play a role in the development of drug-induced venous thrombosis. A significant proportion of the adult population receives 5- alpha reductase inhibitors (5-ARIs) for ongoing treatment of BPH. Therefore, potential serious adverse consequences associated with these treatments should be investigated. This will be a nested case control study among a population of men who received at least one 5ARI or alpha blocker prescription for treatment of BPH during 1995- 2015 in the UK-based Clinical Practice Research Datalink. Cases of VTE (pulmonary embolism [PE] or deep venous thrombosis [DVT]) and matched controls will be derived from the base population. The risk of VTE in relation to timing of drug exposure, duration of use and types of drug will be assessed. Descriptive analyses as well as conditional logistic regression will be used to evaluate the relationship between 5ARIs and the risk of VTE. The proposed study in a large population-based database of high quality will efficiently evaluate the safety of this pharmacologic agent, which will guide the development of guidelines for its use in the prolonged care of BPH patients.
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Distance from glycaemic goal in patients with Type 2 Diabetes Mellitus in the UK — Gail Fernandes ...
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Distance from glycaemic goal in patients with Type 2 Diabetes Mellitus in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-17
Organisations:
Gail Fernandes - Chief Investigator - Merck & Co., Inc.
Gail Fernandes - Corresponding Applicant - Merck & Co., Inc.
Tongtong Wang - Collaborator - Merck & Co., Inc.Outcomes:
HbA1c value at time of treatment intensification and the distance from control goal (<7%).
Description: Technical Summary
This study aims to demonstrate the distance of HbA1c from goal (mean difference from normal target <7%) for metformin monotherapy at the time of treatment intensification in the UK. This study is primarily descriptive, a retrospective database analysis using CPRD. This study will include type 2 DM patients who initiated metformin monotherapy during the index period. The index date will be defined as the date of the first prescription during the index period. Index period is from January 01, 2014 to December 31, 2014. Index date is defined as the date of prescription of metformin monotherapy in the Index period. The primary outcome of the study is to demonstrate the distance to HbA1c goal (mean difference from HbA1c<7%) in patients on metformin mono at the time of treatment intensification in the UK. For the metformin monotherapy group, it would be the addition of the second line therapy that is defined as treatment intensification. We will report difference from HbA1c goal (<7%) at the time of treatment intensification for the metformin monotherapy group in 2014 in the UK including mean value, standard deviation, median, min, max. Additional stratification by age and by baseline HbA1c will be done to describe the change in HbA1c.
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Using longitudinal electronic health records to support evaluations of NHS England new care models â a retrospective analysis using the Clinical Practice Research Datalink. — Puja Myles ...
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Using longitudinal electronic health records to support evaluations of NHS England new care models â a retrospective analysis using the Clinical Practice Research Datalink.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-23
Organisations:
Puja Myles - Chief Investigator - CPRD
Tarita Murray-Thomas - Corresponding Applicant - CPRD
Charles Tallack - Collaborator - NHS England
Helen Booth - Collaborator - CPRD
Jane Druce - Collaborator - Southern Health NHS Foundation Trust
Rachael Williams - Collaborator - CPRDOutcomes: none known
Description: Technical Summary
The English NHS is developing new ways of delivering health care through its new care models programme. These are initially being developed and delivered by 50 vanguards organisations and partnerships throughout the country. Vanguards will pilot a range of models including closer joined up working between community, access to health care quicker and closer to home, and interventions to release GP time to manage more complex conditions.
This analysis will feed into a larger mixed-methods evaluation led by the Vanguards Evaluation team and will focus on estimating pre-intervention and post-intervention healthcare utilisation (e.g. GP consultations, hospital referrals and admissions) using general practice data collected by the Clinical Practice Research Datalink (CPRD). Crude annual and quarterly rates per person time, and 95% confidence intervals, will be aggregated across all CPRD contributing practices, all Vanguard and non-Vanguard practices and individual practices. Rates will be stratified by calendar year, age-band and gender, categories of health care professionals and consultation location. Rates of hospital admission among high risk populations and patients with ambulatory care-sensitive conditions (ACSCs) will also be estimated.
These findings will be used alongside other data collected by the Vanguard evaluation teams to assess the potential impact of their programmes.
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Evaluation of Disease Burden and Treatment Patterns in Postpartum Depression: A Retrospective Observational Study of UK Practice — Christian Bannister ...
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Evaluation of Disease Burden and Treatment Patterns in Postpartum Depression: A Retrospective Observational Study of UK Practice
Datasets:GP data, HES Accident and Emergency; HES Accident and Emergency; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; Pregnancy Register; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-31
Organisations:
Christian Bannister - Chief Investigator - Digital Health Labs Limited
Christian Bannister - Corresponding Applicant - Digital Health Labs Limited
Debra D'Angelo - Collaborator - STATinMED Research
Onur Baser - Collaborator - STATinMED ResearchOutcomes:
Health Care Costs; Comorbidities; Health Care Resource Utilization; Clinical Outcomes (e.g., suicidal ideation or behavior); Adherence & Persistence of Antidepressant Treatment.
Description: Technical Summary
This matched cohort study will use data from the UK Clinical Practice Research Datalink (CPRD), MHRA Pregnancy Registry, Hospital Episode Statistics (HES), and ONS Mortality data from 2009 to 2014 to determine the disease burden of PPD and associated treatment patterns in a real-world clinical setting. The aim of the study is to compare outcomes in patients with PPD versus non-PPD patients. The linked data sets have been selected to enable the estimation of resource utilization and cost, but may also enable better case definitions for the target population and provide a more clearly defined exposure window for depression. The study cohort will consist of women aged 15 to 50 years, that during the study period, had at least one live birth but no stillbirths, and no history of major depressive disorders or prescriptions for antipsychotic medications in the 12 months prior to delivery. The matching of PPD cases to non-PPD controls will be performed, at a 1:1 ratio, using multivariate Propensity Score Matching techniques. Primary outcomes will include health care resource utilization, cost, and comorbidities. Secondary outcomes include treatment adherence, switching, and discontinuation. The comparison of these outcomes, between cases and controls, will be analyzed using appropriate descriptive statistical methodologies.
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Utilisation of antiepileptic medicines in girls and women of childbearing potential — Rachel Charlton ...
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Utilisation of antiepileptic medicines in girls and women of childbearing potential
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Rachel Charlton - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Anita McGrogan - Collaborator - University of Bath
Julia Snowball - Collaborator - University of BathOutcomes:
This is a drug utilisation study, there are no health outcomes of interest. Pregnancy outcomes are included purely as a descriptive variable and no comments or conclusions will be made in relation to potential associations between drug therapies and pregnancy outcomes.
Description: Technical Summary
The use of certain antiepileptic drugs (AEDs) is known to increase the risk of both physical and neurodevelopmental abnormalities in the fetus and child. The European Medicines Agency recently carried out a review of the evidence relating to the use of the AED sodium valproate during pregnancy. Following this review, the guidelines for prescribing sodium valproate to women of childbearing age were changed in January 2015. This drug utilisation study will calculate the prevalence of AED prescribing in all females of childbearing age and in females during pregnancy, between 2007 and 2016, stratified by calendar year, age at prescription and indication for prescribing. It will also look at the incidence of prescribing of each of the different AEDs among 'first-ever users' stratified by calendar year, age at first prescription and indication for prescribing. Finally the study will evaluate the extent to which women switch AED products, including which AEDs they switch to and from, particularly in relation to pregnancy. The data from this study will help inform risk minimisation measures in relation to sodium valproate and other AED exposures in women of childbearing potential.
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Persistence and healthcare resource utilisation in non-valvular atrial fibrillation patients treated with oral anticoagulants in England — Mireia Raluy Callado ...
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Persistence and healthcare resource utilisation in non-valvular atrial fibrillation patients treated with oral anticoagulants in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-17
Organisations:
Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Robert Carroll - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Beth Nordstrom - Collaborator - Evidera, Inc
Nathan Hill - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Donaldson - Collaborator - Evidera, Inc
Sophie Graham - Collaborator - Evidera, Inc
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political ScienceOutcomes:
Oral anticoagulant treatment discontinuation (including treatment cessation, treatment interruption and treatment switching)
- For both all-cause and NVAF-related:
Hospitalisations
Hospital length of stay (LOS)
Number of GP / nurse visits
Number of outpatient visits to the specialist, in particular to the cardiologistDescription: Technical Summary
Novel Oral Anticoagulants (NOACs) have at least equivalent effectiveness and improved safety in comparison to Vitamin K antagonists (VKA) such as warfarin. NOACs do not require regular monitoring of coagulation levels, making treatment simpler and potentially more convenient for patients. These characteristics may in turn improve treatment adherence.
We will use a cohort study design of patients with non-valvular atrial fibrillation (NVAF) newly prescribed NOACs in routine clinical practice in England, identified from retrospective data from the Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics. This study aims to describe the characteristics, treatment patterns and healthcare resource use (HCRU) of patients with NVAF in England who are newly prescribed apixaban, rivaroxaban, dabigatran or warfarin. The risk of treatment discontinuation will be investigated by treatment class using Kaplan-Meier and Cox-regression analyses. The frequency of all-cause and NVAF-related HCRU will be described and rates of use by person-time will be reported. Multivariable modelling will be used to estimate the association of OAC treatment with the rate of HCRU, while controlling for possible confounding factors.
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Cardiovascular risk prediction in daily practice: are risk scores such as QRISK2 accurate enough to be used for individual patient care? — Tjeerd van Staa ...
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Cardiovascular risk prediction in daily practice: are risk scores such as QRISK2 accurate enough to be used for individual patient care?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Alexander Pate - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Richard Emsley - Collaborator - King's College London (KCL)
Taher Hamid - Collaborator - University of ManchesterOutcomes:
Coronary heart disease (angina and myocardial infarction); Stroke; Transient ischaemic attacks.
Description: Technical Summary
We will assess the magnitude of the variation in patient risks due to sources not incorporated into the QRISK2/3 models. The overall objective is to assess what range of risks a patient may have given a predicted risk from the algorithm, which is based on the average for a group. We will run simulations on a patient level, generating the potential bias and excess variation in an individual patient's risk prediction. Hypothesised sources of uncertainty include: omitted covariates, failure to account for time trends, mean imputation of covariates, geographical variation and the interoperability of the model when applying in a different setting. In each stage we will get an estimate of bias as a relative rate and an estimate of the variance. This will be done by simulating potential patient risks based on information derived from the datasets (e.g. association of the time and incidence of CVD). The effect of each source will be calculated separately and then combined at the end to produce a new risk prediction for each patient. We can then look at the range of potential risks of patients with a similar risk core in the original model.
Source - and 22 more projects — click to show
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Predicting atrial fibrillation or atrial flutter (AF/F) using electronic patient health records in the United Kingdom — Phil McEwan ...
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Predicting atrial fibrillation or atrial flutter (AF/F) using electronic patient health records in the United Kingdom
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-17
Organisations:
Phil McEwan - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Phil McEwan - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
David Clifton - Collaborator - University of Oxford
Jason Gordon - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Mark OâNeill - Collaborator - Guy's & St Thomas' NHS Foundation Trust
Matthew Lumley - Collaborator - Pfizer Ltd - UK
Nathan Hill - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Steven Lister - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )Outcomes: none known
Description:
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Epidemiology of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN) in England: a retrospective observational study using CPRD-HES linked data — Roelien Postema ...
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Epidemiology of Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN) in England: a retrospective observational study using CPRD-HES linked data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-31
Organisations:
Roelien Postema - Chief Investigator - Bristol-Myers Squibb - USA ( BMS )
Laura McDonald - Corresponding Applicant - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political ScienceOutcomes: none known
Description: Technical Summary
Systemic lupus erythematosus (SLE) is a rheumatic disease affecting multiple organs. Lupus nephritis (LN), which is kidney inflammation linked to SLE, is a potentially severe SLE complication, yet data from the UK regarding the incidence, prevalence, and characteristics of LN patients is lacking. Recent data suggest prevalence of SLE in the UK is 97 per 100 000, with 86% of observed cases being female. It is thought that the prevalence of LN in SLE patients is between 20-60%; however, a previous estimate in CPRD data using two Read codes specific for LN found only 3% of SLE patients recorded as having LN. The aim of this work is to develop a disease phenotyping algorithm for LN to increase sensitivity of ascertainment of LN patients in CPRD-HES linked data, and subsequently, to characterise these patients and estimate disease incidence and prevalence. Increasing the sensitivity of algorithms to ascertain patients with LN in CPRD data will help to better understand the epidemiology of SLE and LN in England and aid future research involving this patient group.
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Use of dipeptidyl deptidase-4 inhibitors and new-onset rheumatoid arthritis in patients with type 2 diabetes. — Samy Suissa ...
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Use of dipeptidyl deptidase-4 inhibitors and new-onset rheumatoid arthritis in patients with type 2 diabetes.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-30
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Christel Renoux - Collaborator - McGill University
Devin Abrahami - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Marie Hudson - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Incidence of rheumatoid arthritis among patients with type 2 diabetes.
Description: Technical Summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors are effective second-to-third line antidiabetic drugs. Recently, there has been a controversy regarding their potential association with rheumatoid arthritis (RA). While several case reports have suggested a link between their use and the development of RA, an observational study showed a 34% decreased risk. Therefore, the primary objective of this study is to determine whether there is an association between the use of DPP-4 inhibitors and the risk of RA in patients with type 2 diabetes. For this purpose, we will assemble a cohort of patients, at least 18 years old, newly-treated with non-insulin antidiabetic drugs between January 1, 1988 and June 30, 2016, with follow up until June 30, 2017. Use of DPP-4 inhibitors will be modelled as a time-varying variable, where patients will be considered unexposed to DPP-4 inhibitors until 6 months after the first prescription for latency. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of RA associated with use of DPP-4 inhibitors, compared with use of all other antidiabetic drugs. Secondary analyses will assess whether risk varies by cumulative duration of use and time since initiation, and whether there is a drug specific effect.
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Comparative effectiveness of combination therapies in COPD — Samy Suissa ...
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Comparative effectiveness of combination therapies in COPD
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-17
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
COPD exacerbation; Community acquired pneumonia.
Description: Technical Summary
The objective of this study is to assess the effectiveness and safety of maintenance treatment of chronic obstructive pulmonary disease (COPD) with the combination of long-acting beta2-agonist with tiotropium (LABA-TIO) compared to the combination with inhaled corticosteroid (LABA-ICS). We will conduct a matched cohort study among patients with COPD to assess the effect of the LABA-TIO combination compared with the LABA-ICS combination on the time to a COPD exacerbation or the risk of pneumonia. Each patient using for the first time the LABA-TIO combination (without ICS) will be matched to one first time user of the LABA-ICS combination based on propensity score, sex, previous components of the study treatment (LABA only, TIO only, ICS alone, none of these) and the presence of an acute COPD exacerbation in the year before cohort entry. After matching, subjects in the cohort will be followed for up to one year or until the occurrence of the outcome. The time-dependent Cox proportional hazard model will be use to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.
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Estimating heterogeneous treatment effects from routinely collected health data: A case study on anticoagulant therapy for atrial fibrillation patients. — Blanca Gallego Luxan ...
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Estimating heterogeneous treatment effects from routinely collected health data: A case study on anticoagulant therapy for atrial fibrillation patients.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-17
Organisations:
Blanca Gallego Luxan - Chief Investigator - Macquarie University
Blanca Gallego Luxan - Corresponding Applicant - Macquarie University
James Sheppard - Collaborator - University of Oxford
Jiazhen He - Collaborator - University of Melbourne
Jie Zhu - Collaborator - Macquarie University
Karin Verspoor - Collaborator - University of Melbourne
Polina Putrik - Collaborator - Monash University
Thierry Wendling - Collaborator - Not from an Organisation
William Tong - Collaborator - Macquarie UniversityOutcomes:
Ischaemic stroke and systemic embolism; Major bleeding; All-cause mortality.
Description: Technical Summary
We aim to estimate heterogeneous treatment effects of anticoagulants in atrial fibrillation patients. This will include conducting pairwise comparisons between non-vitamin K antagonist oral anticoagulants (such as rivaroxaban and apixaban), vitamin K antagonists (such as warfarin), and no anticoagulant treatment. For each patient, an index date is set as the date of anticoagulant therapy initiation following a diagnosis of atrial fibrillation. When comparing against no treatment, the index date becomes the date of first diagnosis. The primary outcomes under consideration are stroke and systemic embolism, major bleeding and all-cause mortality within two years of the index date. When therapy discontinuation or therapy switching take place within the follow-up period, the patient is considered lost to follow-up. We choose to use Target Maximum Likelihood learning. This approach is doubly robust if at least one of the treatment and outcome mechanisms is correctly specified. Both probability of treatment and outcome will be modelled using Bayesian Additive Regression Trees. Findings will be compared to estimates using the more traditional Cox regression model. Estimates from these observational studies will be compared with those of appropriate patients in existing clinical trials.
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Medication Use and Pregnancy Outcomes in Women with Systemic Lupus Erythematosus within the Clinical Practice Research Datalink — Denise Elsasser Dietz ...
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Medication Use and Pregnancy Outcomes in Women with Systemic Lupus Erythematosus within the Clinical Practice Research Datalink
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Denise Elsasser Dietz - Chief Investigator - Rutgers, The State University of New Jersey
Denise Elsasser Dietz - Corresponding Applicant - Rutgers, The State University of New Jersey
Anne Dilley - Collaborator - Biogen
Demissie Kitaw - Collaborator - Rutgers, The State University of New Jersey
Jeffery (Jeff) Allen - Collaborator - Biogen
Lin Young - Collaborator - Rutgers, The State University of New Jersey
Stephan Schwander - Collaborator - Rutgers, The State University of New Jersey
Susan Eaton - Collaborator - Biogen
Teresa Janevic - Collaborator - Icahn School of Medicine at Mount Sinai
Todd Rosen - Collaborator - Rutgers, The State University of New JerseyOutcomes: none known
Description:
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Trends in survival of older care home residents in England since 1995: a multi-cohort study — Ruth Hancock ...
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Trends in survival of older care home residents in England since 1995: a multi-cohort study
Datasets:GP data, ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-07
Organisations:
Ruth Hancock - Chief Investigator - University of East Anglia
Ferran Espuny Pujol - Corresponding Applicant - University College London ( UCL )
Marcello Morciano - Collaborator - University of East AngliaOutcomes:
Unadjusted 6-month, 1-year and 2-year survival rates for each year from 1995 to 2015 among care home residents aged 65 and over (GP patients aged 65+ and with a record of care home residence in the earlier of each pair of time points);Trends over the same periods in 6-month, 1-year and 2- year survival, adjusting for age, gender and patient level index of multiple deprivation of care home residents aged 65+ compared with community-dwelling people aged 65+ (GP patients aged 65+ and with no record of residence in care home in the earlier of each pair of time points).
Description: Technical Summary
Policy emphasis on enabling older people to remain in their own homes means that care home entry may be occurring at later ages. Whether this is resulting in more disparity between survival of care home residents and those living in the community is unknown; previous studies examined only single cohorts. How survival in care homes is changing is relevant for health and social care planning. Objective: To examine trends since 1995 in 6-month, 1-year and 2-year survival of older care home residents in England, compared with community-dwelling older people, adjusting for age, gender and patient level index of multiple deprivation. Methods: For each year from 1995, patients in CPRD aged 65+ will be classified as care home residents or community dwelling using GP recorded events. Their 6-month, 1-year and 2-year survival will be determined from linked ONS mortality register data. Data analysis: Unadjusted (other than for time period) and adjusted Cox proportional hazard and logistic regression models of survival will be estimated for care home residents and community dwelling people separately; and for the two groups combined, entering care home residence as a co-variate (testing for significant interactions with age, gender and deprivation).
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Identification of high cost patients in primary and secondary care and an analysis of their utilisation patterns, and social and demographic characteristics. — Sarah Deeny ...
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Identification of high cost patients in primary and secondary care and an analysis of their utilisation patterns, and social and demographic characteristics.
Datasets:GP data, 2011 Rural-Urban Classification at LSOA level; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Sarah Deeny - Chief Investigator - The Health Foundation
Adam Steventon - Collaborator - The Health Foundation
Anya Gopfert - Collaborator - The Health Foundation
Arne Wolters - Collaborator - The Health Foundation
Carlotta Greci - Collaborator - The Health Foundation
Fiona Grimm - Collaborator - The Health Foundation
Isaac Barker - Collaborator - The Health Foundation
Karen Hodgson - Collaborator - The Health Foundation
Kathryn Dreyer - Collaborator - The Health Foundation
Mai Stafford - Collaborator - The Health Foundation
Rocco Friebel - Collaborator - Imperial College London
Will Parry - Collaborator - The Health FoundationOutcomes:
ypes of health care utilisation; Cost of health care utilisation.
Description: Technical Summary
At the patient level, for patients of all ages, we will calculate health care utilisation across primary and secondary care for a two year period from March 2014 to March 2016, and cost each part of care delivered using available data on direct costs to the NHS. In primary care, we will quantify and attach costs to contacts with clinical staff (GPs and nurses), diagnostic tests, immunisations and prescriptions for medicines and devices. In secondary care, we will quantify utilisation in accident and emergency departments, spells of admitted patient care, and attendance at outpatient clinics. We will then use the national tariff payment system to calculate healthcare resource groups (HRGs) for each occurrence of care. We will then analyse the cost make-up of the top 1% and top 5% for our two year period, and compare their demographic (age, sex, ethnicity, region, socio-economic deprivation) and clinical characteristics (long-term conditions as per primary care clinical coding) to the rest of the population. We will then investigate whether the utilisation cost make-up of the high-cost patients differs across certain subgroups; age bands, patients with a mental health condition, and patients living alone.
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MENTAL COMORBIDITIES AND USE OF PSYCHOTROPIC MEDICATIONS IN PATIENTS WITH AUTISM SPECTRUM DISORDERS IN THE UNITED KINGDOM — Brigitta Monz ...
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MENTAL COMORBIDITIES AND USE OF PSYCHOTROPIC MEDICATIONS IN PATIENTS WITH AUTISM SPECTRUM DISORDERS IN THE UNITED KINGDOM
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Brigitta Monz - Chief Investigator - Boehringer-Ingelheim Germany
Richard Houghton - Corresponding Applicant - Roche
Chuang (Tony) Liu - Collaborator - Roche
David Evans - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Federico Bolognani - Collaborator - F. Hoffmann - La Roche LtdOutcomes:
Demographics and clinical characteristics; Comorbid conditions; Use of psychotropic medications; Health resource utilization, e.g. health care provider visits; Comparison of above features between autism patients and comparison group.
Description: Technical Summary
This is a retrospective cohort study using secondary data. Autism Spectrum Disorder (ASD) subjects will be identified and included in the study based on READ codes; as will two comparison groups, namely a non-ASD group and attention deficit hyperactive disorder (ADHD) group. Baseline characteristics, selected psychiatric comorbid conditions and selected classes of psychotropic medications will be described in patients with ASD and the comparison groups. Multivariate regression models will be fitted to explore factors associated with psychotropic medication use among patients with ASD.
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Adverse drug reactions in UK primary care consultations: a retrospective cohort study to evaluate impact on appointments, hospitalization, and treatment discontinuation — Sarah Chapman ...
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Adverse drug reactions in UK primary care consultations: a retrospective cohort study to evaluate impact on appointments, hospitalization, and treatment discontinuation
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-07
Organisations:
Sarah Chapman - Chief Investigator - University of Bath
Sarah Chapman - Corresponding Applicant - University of Bath
Li Wei - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
Aim: To estimate the impact of ADRs in UK general practice.
Objectives:
To evaluate whether these consultations are associated with increased rates of subsequent appointments, hospitalization and medication discontinuation compared to other attenders without ADRs .
Method: We will identify the ADR cohort where ADR-related codes have been recorded for a consultation in 2014. We will match each member of the ADR cohort to comparators (1:2) of the same age, gender and utilizing the same GP practice, who have a consultation at the same time without an ADR-related code. We will compare available data on the ADR cohort to the comparator cohort over a year following their ADR related appointment on number of subsequent any GP appointments, any hospitalization, and changes in prescription. We will then repeat these analyses five times for the five most frequently dispensed drug users in 2014 and in each analysis, both the ADR and comparator cohorts will come from the same drug users.
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Alzheimer's treatment and the risk of serious adverse events — Samy Suissa ...
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Alzheimer's treatment and the risk of serious adverse events
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Samy Suissa - Chief Investigator - McGill University
Machelle Wilchesky - Corresponding Applicant - McGill University
Edeltraut Kroger - Collaborator - McGill University
Jacques Benisty - Collaborator - Not from an Organisation
Kathleen Andersen - Collaborator - McGill University
Kristian Filion - Collaborator - McGill University
Nathalie Champoux - Collaborator - University Of Montreal
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Pierre Ernst - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Ronald Grad - Collaborator - McGill UniversityOutcomes:
Bradyarrhythmia; Supraventricular tachyarrhythmia; Atrial fibrillation/flutter; Ventricular tachycardia or ventricular fibrillation; Syncope; Chronic obstructive pulmonary disease;
Gastrointestinal bleeding; Drug utilization; Neuropsychiatric symptoms.Description: Technical Summary
Objective: Despite the frequent and increasing use of cholinesterase inhibitors (ChEI) and memantine to manage Alzheimer's disease and related disorders, the safety of these medications in a real-world setting remains unclear. Our primary objective is to compare the risk of cardiac arrhythmias among Alzheimer's patients receiving either a ChEI or memantine to that in Alzheimer's patients unexposed to these medications. Secondary objectives include comparing the risks of syncope, chronic obstructive pulmonary disease exacerbations, gastrointestinal bleeding, and mortality, and describing characteristics associated with treatment persistence and patterns of drug use. Methods: We will assemble a cohort of all patients diagnosed with Alzheimer's within the CPRD between April 1998 and March 2017 with at least one year of CPRD history prior to cohort entry. Data analysis: Our nested case-control analysis will use risk-set sampling, and conditional logistic regression models will be used to estimate hazard ratios of ChEI or memantine use versus non-use for each adverse event. All models will be adjusted for demographic, clinical and lifestyle variables, and use of other medications. Patterns of drug utilization, including initiation, persistence and switching will also be examined.
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Epidemiology of bleeding complications post-Acute Coronary Syndrome within the UK primary care setting — Mamas Mamas ...
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Epidemiology of bleeding complications post-Acute Coronary Syndrome within the UK primary care setting
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-16
Organisations:
Mamas Mamas - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
John Edwards - Collaborator - Keele University
Muhammad Rashid - Collaborator - Keele University
Nafiu Ismail - Collaborator - Keele University
Umesh Kadam - Collaborator - University of LeicesterOutcomes:
Bleeding complications; All-cause mortality.
Description: Technical Summary
Objectives: To determine the rate of bleeding post hospital discharge, the characteristics of patients likely to develop these bleeding complications and whether these bleeds increase the rate of death. Methods: Using a retrospective cohort design, we will study patients 18 years and over with a new diagnosis of heart attack and no prior record of heart attack in the preceding 2 years within CPRD and follow them for bleeding consultation records. Follow-up will start from date of hospital discharge until the date they no longer contribute to CPRD due to death or leaving practice or practice leaving CPRD or end of 2016. We will compare the rate of death among those with bleeding consultation post hospital discharge and those without. Data analysis: First the rate of bleeding post hospital discharge will be determined per 1000 person years at risk. Second, associations between bleeding post hospital discharge with socio-demographic characteristics, baseline clinical characteristics, in-hospital intervention and discharge medication will be investigated to determine the risk factors of bleeding. Finally, association between bleeding post-hospital discharge and death from all cause will be investigated, adjusting for risk factors identified in stage 2 above using Cox proportional hazard regression.
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EMERALD: Exploring Mental Illness and Diabetes through a Longitudinal Data study — Najma Siddiqi ...
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EMERALD: Exploring Mental Illness and Diabetes through a Longitudinal Data study
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; Mental Health Services Data Set (MHSDS); ONS Death Registration Data; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Najma Siddiqi - Chief Investigator - University of York
Najma Siddiqi - Corresponding Applicant - University of York
Catherine Hewitt - Collaborator - University of York
David Shiers - Collaborator - University of York
Johanna Taylor - Collaborator - University of York
Kate Bosanquet - Collaborator - University of York
Lu Han - Collaborator - University of York
Lu Han - Collaborator - University of York
Panagiotis Kasteridis - Collaborator - University of York
Richard IG Holt - Collaborator - University of Southampton
Rita Santos - Collaborator - University of York
Rowena Jacobs - Collaborator - University of York
Sarah Anderson - Collaborator - University of Leeds
Shehzad Ali - Collaborator - University of York
Simon Gilbody - Collaborator - University of York
Stephanie Prady - Collaborator - University of York
Tim Doran - Collaborator - University of YorkOutcomes:
Diabetes status and onset; Diabetic and cardiovascular control (measured by recorded HbA1c, blood pressure, cholesterol levels); Diabetic complications: acute hyperglycemic events, hypoglycemia, micro-vascular complications [retinopathy, neuropathy, nephropathy], macro-vascular complications [coronary artery disease, cerebrovascular disease, peripheral arterial disease]; Hospital admissions for the above conditions; Mental health outcomes (including SMI relapses and markers of depression or anxiety); Mortality; Healthcare utilisation (including the number and type of primary care consultations) and costs; Healthcare interventions (e.g. medication, care pathways and referrals).
Description: Technical Summary
Background: People with severe mental illness (SMI) have poorer physical health and lower life expectancy than the general population. A 2-3 fold increased risk of diabetes and its associated complications contribute to this health inequality.
Aim: Our aim is to improve understanding of the increased risks of diabetes and poorer diabetes outcomes for people with SMI.
Methods: We will interrogate linked primary care and hospital records for a large representative sample of adults with SMI, SMI and diabetes, and a matched control group with diabetes but no SMI. We will quantify risk factors implicated in development of diabetes in people with SMI, and variation in health outcomes in people with comorbid SMI and diabetes. We will explore variations in diabetes screening and management, estimate costs for these, and determine the role of healthcare interventions in contributing to health outcomes. Analysis will use a range of statistical models, which take account of the structure of the data for each research objective (e.g. multilevel modelling to explore the impact of key variables, and matching methods to compare disparities in healthcare).
Impact: This knowledge will help healthcare commissioners, providers and researchers to develop targeted effective interventions for this population and improve existing services.
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Children and Adolescents with PaRental mental Illness: Understanding the 'who' and the 'how' of targetting interventions? 'CAPRI' — Kathryn Abel ...
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Children and Adolescents with PaRental mental Illness: Understanding the 'who' and the 'how' of targetting interventions? 'CAPRI'
Datasets:GP data, CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-30
Organisations:
Kathryn Abel - Chief Investigator - University of Manchester
Matthias Pierce - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Holly Hope - Collaborator - University of Manchester
Richard Emsley - Collaborator - King's College London (KCL)Outcomes:
Fertility rate (miscarriages, stillbirths and livebirths per year) comparing mothers with a mental illness with those without.
- Period prevalence of children born to mothers with a mental illness
- Rates of health service utilisation, defined by a consultation in primary care (face to face, telephone, other) and hospital visits (in-patient, outpatient and accident and emergency), associated with offspring with a mother with a mental illness
- Health service costs associated with off spring with a mother with a mental illness
- Vaccine uptake in children (up to age 5) with a mother with a mental illness
- Specific childhood physical health conditions: atopic disorders, infections, obesity, cancer, and accidents and injuries
- Causes of infertility comparing women with mental illness versus those without
- Specific childhood neurodevelopmental conditions: cerebral palsy, epilepsy, autism spectrum disorder, intellectual disability, attention deficit hyperactivity disorderDescription: Technical Summary
Having a parent experiencing mental illness increases the risk of infant mortality and developing mental illness during adulthood. However, little is known about the scale of parental mental illness and other risks for this group of vulnerable young people. The fertility rate of women with a mental illness diagnosis will be determined and compared with women who do not have a mental illness. We will then identify a cohort of offspring of mothers with mental illness, using a probabilistic linkage algorithm. Exposed children will enter the cohort from the date of maternal mental illness diagnosis, or from birth if diagnosis within five years prior to birth.
We will use this cohort to estimate the period-prevalence of children with a mother with mental illness. Secular trends will be examined to assess whether this is affected by the widespread introduction of atypical antipsychotic agents and by ecological changes. Healthcare utilisation and associated costs will be compared between exposed and unexposed children. Finally, the association between an offspring with a mother with a mental illness and uptake of vaccination during early childhood will be quantified.
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Use of anti-Alzheimer's disease treatments among individuals with mild cognitive impairment — Lisa Vinikoor...
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Use of anti-Alzheimer's disease treatments among individuals with mild cognitive impairment
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-22
Organisations:
Lisa Vinikoor-Imler - Chief Investigator - Biogen
Lisa Vinikoor-Imler - Corresponding Applicant - Biogen
Li Li - Collaborator - Biogen
Michele Potashman - Collaborator - Biogen
Susan Eaton - Collaborator - BiogenOutcomes:
Use of anti-AD medications.
Description: Technical Summary
The main objective of this study is to determine the proportion of individuals in the UK with mild cognitive impairment who were prescribed anti-Alzheimer's disease medications. A secondary objective is to learn about the timing and frequency of the use of these medications among those who later develop dementia. This will be a descriptive analysis. The first objective will be accomplished by determining how many of the mild cognitive impairment patients were prescribed anti-Alzheimer's disease medications prior to either their first diagnosis of dementia or their end date in the database (whichever is earliest). Once this group is defined, the proportion of mild cognitive impairment patients receiving a prescription will be calculated. The secondary objective will be addressed by reviewing the subset of patients with mild cognitive impairment who also have a dementia diagnosis and received a prescription for an anti-Alzheimer's disease drug prior to their dementia diagnosis. Among these patients, the time between the first prescription for these drugs and the first dementia diagnosis will be measured. Descriptive statistics will summarize this time measurement. Similarly, descriptive statistics will also be used to examine the number of these prescriptions per individual during the same time window.
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Decline In lung function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO) — David Price ...
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Decline In lung function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-08
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Claudia Cabrera - Collaborator - Astra Zeneca R&D Molndal Sweden
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Marcus Ngantcha - Collaborator - Cambridge Research Support
Paul M. Dorinsky - Collaborator - Pearl Theraputics
Sen Yang - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte LtdOutcomes: none known
Description: Technical Summary
The study aims to identify patients who are at high risk of rapid lung function decline and to study the effectiveness of COPD maintenance therapies. Patients diagnosed with mild to moderate COPD, a history of smoking and repeated FEV1 measurements will be included. Initially, the study will validate an existing prediction model for FEV1 decline under minimal therapy, comparing observed and predicted FEV1 values. The subgroup of patients with high risk (>80%) of rapid decline (â¥40 ml/year) will be characterised at time of diagnosis and initiation of maintenance therapy. Differences between individualâs observed and predicted FEV1 values (calculated from the validated prediction model or a newly developed model) will be described after initiation of maintenance therapies. Analyses will be performed for patients with first maintenance therapy being a single inhaler, dual therapy or triple therapy, separately. In addition, patients initiated on triple therapy will be matched to similar patients on minimal therapy, based on potential confounders. A multilevel model for change (mixed linear regression) will be used to compare the rate of FEV1 decline between matched patients. Conditional negative binomial regression and stratified Cox-regression will be used to analyse differences in exacerbation rates and time to first COPD-related hospitalisation respectively.
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Regional and patient variations in treatment pathways to access hip and knee replacement surgery, and the effects on surgical outcomes — Andrew Judge ...
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Regional and patient variations in treatment pathways to access hip and knee replacement surgery, and the effects on surgical outcomes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-02
Organisations:
Andrew Judge - Chief Investigator - University of Oxford
John Broomfield - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Sion Glyn-Jones - Collaborator - University of OxfordOutcomes:
Mortality ⢠PROMS ⢠Failure / Revision surgery
⢠Prosthetic Joint Infection ⢠Healthcare Costs ⢠Incidence of arthroplasty
⢠Venous Thrombeoembolism ⢠Readmission for MI, CVA, PE ⢠Healthcare related quality of lifeDescription: Technical Summary
Objective
To identify patients that undergo hip and knee replacements and describe the treatment pathways taken to identify whether there is any variation according to patient characteristics (age, sex, social class, body mass index (BMI), comorbidities, medications, smoking status etc.) and geographical region. We further aim to investigate whether the treatment pathway and itsâ duration affects the outcome of hip or knee replacement surgery.Methods
determine whether they change as patients progress through the pathway.
b. Describe whether patient characteristics and geographical region are associated with timing to receive treatments, and further describe variations according to whether or not patients receive both surgical and non-surgical treatments.
3. Does the duration or pattern of treatment pathway prior to referral to a surgeon affect patient outcomes of surgery?
a. In patients that ultimately received hip or knee replacement surgery, do differences in the treatments offered during the pathway affect patient outcomes of surgery?
b. In patients that ultimately received hip or knee replacement surgery, does the duration of the treatment pathway affect patient outcomes of surgery?
c. Are there any definable patient characteristics or regional variations that influence the outcome of treatment?Rationale
OA is one of the most common diseases worldwide. It is a chronic, progressive, disabling disease with many factors influencing its development and progression. Relatively little is still known about how patient experiences and socioeconomic status effects access to care and outcome of treatment. Further understanding the referral patterns and different routes of access to care for OA patients and their wider characteristics can inform, and enhance
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Association between antineoplastic therapies and venous thromboembolism in patients with active cancer — Carlos Martinez ...
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Association between antineoplastic therapies and venous thromboembolism in patients with active cancer
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-21
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Antonio Curcio - Collaborator - University Magna Graecia
Bob Weijs - Collaborator - Maastricht University
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Michela Giustozzi - Collaborator - University of Perugia
Saulius Sudikas - Collaborator - Vilnius City Clinical Hospital
Thalia Field - Collaborator - University Of British ColumbiaOutcomes:
Venous thromboembolism.
Description: Technical Summary
This study aims to investigate the association between cancer treatment and the risk of venous thromboembolism (VTE). A cohort of patients with active cancer will be generated and followed for the occurrence of VTE events dependent on the type of cancer therapy. Active cancer will be defined as the 6 month period following either a cancer diagnosis, a cancer therapy, the presence of metastases or a cancer recurrence. Cancer therapy will consist of chemotherapy, cytotoxic drugs, radiation, hormones and immunotherapy. VTE events will include deep vein thromboses and pulmonary embolisms. Adjusted hazard rate ratios of the association between cancer therapy and VTE events will be derived from multivariate Cox regression models including type of cancer therapy as time-dependent variables.
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Cardiovascular Disease Risk Prediction Screening Using Electronic Health Records — Angela Wood ...
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Cardiovascular Disease Risk Prediction Screening Using Electronic Health Records
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Townsend Score; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-17
Organisations:
Angela Wood - Chief Investigator - University of Cambridge
Angela Wood - Corresponding Applicant - University of Cambridge
David Stevens - Collaborator - University of Cambridge
Ellie Paige - Collaborator - The Australian National University
Jessica Barrett - Collaborator - University of Cambridge
Juliet Usher-Smith - Collaborator - University of Cambridge
Luanluan Sun - Collaborator - University of Cambridge
Matthew Arnold - Collaborator - Astra Zeneca Ltd - UK Headquarters
Robson Machado - Collaborator - University of Cambridge
Stephen Kaptoge - Collaborator - University of CambridgeOutcomes:
10-year risk of developing fatal or non-fatal cardiovascular disease
Description: Technical Summary
Stratification of individuals according to their estimated cardiovascular disease (CVD) risk is used to guide clinical decision-making. Current UK guidelines for CVD risk assessment recommend the use of already recorded risk factors in electronic health records to prioritise patients for a full formal risk assessment, although there is no guidance on how this should be achieved. Our team is currently developing methods for a CVD risk modelling approach that utilises already available information on risk predictors while accounting for sporadically observed/missing data and can estimate risk for a large proportion of the target population using electronic patient records from a subset of 10 general practices contributing to The Health Improvement Network (THIN10). The proposed work in CPRD will involve several follow-up avenues to this work including: applying these methods to derive and internally validate a risk prediction model using a large sample size from CPRD with validated CVD endpoints and undertake public health modelling, optimising thresholds for a CVD "pre-screening tool", and methods work investigating optimal personalised and stratified (i.e. stratified by risk thresholds) screening intervals.
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Incidence and prevalence of autoimmune hepatitis in the UK. A population-based cohort study. — Joe West ...
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Incidence and prevalence of autoimmune hepatitis in the UK. A population-based cohort study.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-07
Organisations:
Joe West - Chief Investigator - University of Nottingham
Lisbet Gronbaek - Corresponding Applicant - Aarhus University Hospital
Colin Crooks - Collaborator - University of Nottingham
Harmony Otete - Collaborator - University Of Central Lancashire
Peter Jepsen - Collaborator - Aarhus University Hospital
Timothy Card - Collaborator - University of NottinghamOutcomes:
An AIH diagnosis will be defined by a record of one or more of the Read codes of AIH (and in subset analyses; by one or more of the Read codes of AIH and/ or ICD-10 codes of AIH) as listed in appendix A. Diagnostic criteria for AIH are well-established, and the sensitivity of the coded diagnosis for AIH (using the exact same Read codes as in the provided study) for detection of this condition in general practice and therefore in the CPRD is 89%. In the proposed study, three cohorts of patients with AIH will be defined with the most restrictive cohort III representing the lowest believable number of AIH cases. In a supplemental analysis, we will also assess whether there are cases only identified in HES. Data source/s: Codes for inclusion and exclusion will be obtained from the CPRD and HES. Test results regarding viral hepatitis will be obtained from the CPRD. Dates and fact of death will be obtained from the CPRD. IMD scores for included patients will be obtained by linking CPRD data to deprivation data from 1997 to 2016. The IMD score will defined by quintiles at General Practice level for the obtained data.
Description: Technical Summary
Using data from the Clinical Practice Research Database in the UK, the objective of this study is to estimate the incidence and prevalence of autoimmune hepatitis in the UK. We will use a validated method of ascertaining people with autoimmune hepatitis to quantify the incidence and prevalence of the disease. We will also describe the variation in these measures of disease occurrence by various sociodemographic characteristics.
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Effectiveness of triple therapy versus dual bronchodilation in patients with chronic obstructive pulmonary disease — David Price ...
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Effectiveness of triple therapy versus dual bronchodilation in patients with chronic obstructive pulmonary disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-03
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jaco Voorham - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Janwillem Kocks - Collaborator - University Medical Centre Groningen
Mario Scuri - Collaborator - ChiesiOutcomes:
Primary outcome (Objectives 1 &2): Occurrence of COPD exacerbation; Secondary outcome: Occurrence of acute courses of oral corticosteroid; Secondary outcome: Occurrence of pneumonia diagnosis; Primary outcome (Objective 3): Average decline in forced expiratory volume in first second (FEV1) per year of follow-up; Secondary outcome: Occurrence of antibiotic prescription following lower respiratory consultation; Secondary outcome: Occurrence of hospitalisation with COPD as primary diagnosis; Secondary outcome: mMRC score within 18 months after index date; Secondary outcome: Occurrence of time to first A&E attendance related to COPD.
Description: Technical Summary
Two designs will be used to study the effectiveness of triple therapy [TT] (inhaled corticosteroids (ICS) with long-acting muscarinic antagonist and beta agonist [LAMA+LABA]) in COPD patients with a history of smoking: A. Patients who step-up from LAMA+LABA to TT will be compared with patients who remain on LAMA+LABA B. Patients who step-up from LAMA to TT will be compared with patients who step up to LAMA+LABA Primary outcomes: 1. COPD exacerbations: number in first year and time to first event 2. Average decline in forced expiratory volume in first second [FEV1] per year The study uses a historic cohort design, and matches the patients between treatment groups, according to relevant demographic and clinical characteristics. A one year baseline period is used to identify variables for matching, and patients are followed up during an outcome period of at least one year. Exacerbations will be compared using conditional negative binomial regression to estimate the adjusted rate ratios with 95% confidence intervals. Stratified Cox regression will be used to compare the time to first exacerbation. The change in FEV1 over time will be analysed using a multilevel regression model. Effect modification by patient and therapy characteristics will be studied by including interaction-terms.
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Variation in recording of alcohol use in CPRD: a cross-sectional study — Emily Herrett ...
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Variation in recording of alcohol use in CPRD: a cross-sectional study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-08-31
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Crellin - Corresponding Applicant - The Health Foundation
Elizabeth Crellin - Collaborator - The Health Foundation
Jennifer Quint - Collaborator - Imperial College London
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachel Denholm - Collaborator - University of Bristol
Sarah Cook - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Alcohol use recording:
- Alcohol screening using recommended tools (AUDIT and FAST)
- Alcohol units per week
- Other alcohol screening recorded using morbidity codesDescription: Technical Summary
Alcohol screening for adults is recommended by the National Institute for Health and Care Excellence (NICE) as an integral part of practice for the prevention of alcohol-use disorders. We will assess the utility of recorded alcohol data within the Clinical Practice Research Datalink (CPRD) by assessing prevalence and accuracy of recording of alcohol. We will determine the prevalence of screening at different levels: alcohol screening using recommended screening tools (AUDIT or FAST), alcohol units per week, or other alcohol screening using morbidity codes. We will also investigate how prevalence of recording varies with patient characteristics. We will conduct a cross-sectional study, where the study population is all people aged 16 years or over who were registered in CPRD (up-to-standard) on the study date. The study date will be chosen to allow us to use the most recent data available in CPRD. We will then validate information gathered from morbidity codes and alcohol units per week, using scores from recommended screening tools as the gold standard. This study will provide insight into how well routine practice is aligned with NICE guidelines for alcohol screening, and help establish best practise in using CPRD data to investigate alcohol use in research.
Source
2017 - 07
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Effectiveness of proton pump inhibitors in idiopathic pulmonary fibrosis — Samy Suissa ...
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Effectiveness of proton pump inhibitors in idiopathic pulmonary fibrosis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-04
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Deborah Assayag - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill University
Tanja Tran - Collaborator - McGill UniversityOutcomes:
Death from any cause
- Respiratory-related deaths
- HospitalisationsDescription: Technical Summary
Recent observational studies and post-hoc analyses of data from placebo arms of randomised controlled trials in patients with IPF have led to a conditional recommendation of anti-acid therapy as treatment for IPF. However, the evidence supporting the recommendation is weak and may even be biased leading to spurious associations. To date, no well-designed observational study with sufficiently large sample size and follow-up has investigated the effectiveness of PPIs in IPF. Thus, the objective of this study will be to assess the associations between PPIs and all-cause mortality and hospitalisations in a cohort of IPF patients who are at least 40 years of age and newly diagnosed with IPF on or after January 1, 2002 until December 31, 2015. Exposure to PPIs will be assessed in a time-dependent manner. All patients will be followed until death, end of registration with the practice, or end of the study period (December 31, 2016). Time-dependent Cox proportional hazard models will be used to estimate hazard ratios and 95% confidence intervals of death associated with the use of PPIs when compared to non-use. Additional analyses will assess the risk of hospitalisation associated with PPI use.
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Meningococcal B vaccine: incidence of convulsion following vaccination and compliance with timing of vaccine doses in the UK — Suzie Seabroke ...
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Meningococcal B vaccine: incidence of convulsion following vaccination and compliance with timing of vaccine doses in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Suzie Seabroke - Chief Investigator - MHRA
Suzie Seabroke - Corresponding Applicant - MHRA
Jenny Wong - Collaborator - MHRAOutcomes:
Incidence of convulsions following routine vaccination at 8 weeks, 16 weeks, 12 months and 3 years 4 months; Timing of vaccination in relation to date of birth for infants vaccinated with routine childhood vaccinations.
Description: Technical Summary
The objectives of this study are firstly to investigate a potential risk of convulsions following vaccination with Men B vaccine in an ecological analysis by comparing incidence rates of convulsions following routine vaccination before and after the introduction of the Men B vaccine into the routine schedule. Age-specific incidence rates of convulsion following routine vaccination at 8 weeks, 16 weeks and 12 months of age in the 5 years prior to and 14 months after the introduction of Men B vaccine will be determined. Poisson regression analysis will assess temporal trends before and after the introduction of Men B vaccine. The second objective is to evaluate whether the introduction of the Men B vaccine is having an impact on infants/parents returning for subsequent doses on time. Timing of vaccination will be investigated for all 3 doses of Men B vaccine at 8, 16 weeks and 12 months, rotavirus vaccine at 8 and 12 weeks and pneumococcal vaccine at 8, 16 weeks and 12 months in time periods prior to and after the introduction of Men B vaccine. Kaplan-Meier curves presented for infants vaccinated either prior to or after the introduction of Men B vaccine.
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Treatment of acute lower respiratory tract infections in patients with and without asthma — Esther van der Werf...
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Treatment of acute lower respiratory tract infections in patients with and without asthma
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-25
Organisations:
Esther van der Werf-Kok - Chief Investigator - University of Bristol
Esther van der Werf-Kok - Corresponding Applicant - University of Bristol
Alastair Hay - Collaborator - University of Bristol
Rachel Denholm - Collaborator - University of BristolOutcomes:
Antibiotic prescription; Asthma medication prescription; No treatment.
Description: Technical Summary
British Thoracic Society asthma guidelines recommend that treatment for acute lower respiratory tract infections (ALRTI) in asthmatics should be a 'step-up' in asthma-medication and not antibiotics. However, anecdotal evidence suggests that simultaneous prescriptions of antibiotics is extremely common, but little is known about the precise treatment patterns of ALRTI among asthmatics in primary care in the UK. We will investigate GPs prescribing patterns of antibiotics and asthma-medication in over 100,000 patients aged 12 years and older who were diagnosed with an ALRTI in 2014 and 2015. We will investigate whether asthmatics were more or less likely to be prescribed antibiotics compared to non-asthmatics. Multivariable regression will be used to model the association between asthmatic status and antibiotic and asthma-medication use. Furthermore, we will investigate whether practice (e.g. geographic), GP and patient-level (e.g. age, sex, and ALRTI and antibiotic prescription history) factors influence the association using mixed-effect regression models. Results from this study will provide an insight into the prescribing of antibiotics for ALRTI amongst asthmatics, and identify potential factors that may be associated with sub-optimal management. Findings will inform the development of a future intervention study to reduce the inappropriate use of antibiotics in patients with asthma.
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Healthcare resource utilisation and costs of major bleeding events and ischemic stroke among non-valvular atrial fibrillations patients in the UK — Farnaz Vahidnia ...
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Healthcare resource utilisation and costs of major bleeding events and ischemic stroke among non-valvular atrial fibrillations patients in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-24
Organisations:
Farnaz Vahidnia - Chief Investigator - Roche
Nadia Foskett - Corresponding Applicant - UCB BioSciences, Inc.
Fabian Wiktorowski - Collaborator - Roche
Frank Corvino - Collaborator - Genesis Research LLC
Hans Petri - Collaborator - Petri Consulting Ltd
Marcus Hibell - Collaborator - Roche
Mark John Sculpher - Collaborator - University of York
Matthew McEnany - Collaborator - Genesis Research LLC
Nadia Foskett - Collaborator - UCB BioSciences, Inc.
Yingjie Ding - Collaborator - Genesis Research LLCOutcomes:
Healthcare resource utilisation; Costs to NHS.
Description: Technical Summary
The study objective is to describe healthcare resource utilisation & long-term healthcare costs in patients with/ without major bleeding events or with/without ischemic stroke in a recent population of patients with non-valvular atrial fibrillation using UK CPRD linked to England Hospital Episode Statistics (HES, admitted patients, outpatient, Accident and Emergency files). We will use data from 2011 onward to get insights into recent patient populations including those treated with new oral anticoagulants. In this retrospective observational study we will include patients with the first diagnosis of atrial fibrillation in 2011 or later and ischemic stroke or major bleeding and matched patients with atrial fibrillation and without ischemic stroke /major bleeding or essential hypertension and without atrial fibrillation, ischemic stroke or major bleeding. We will describe NHS resource utilisation and costs (by category and total NHS costs) for the period of 30 days after the event or after hospital discharge, and then for the periods of 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, and 36 months after the event. The study will provide new data on long-term resource utilisation and costs to the NHS among atrial fibrillation patients with ischemic stroke or major bleeding.
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Multinational Observational Database Study on Imminent Osteoporotic Fracture Risk — Daniel Prieto...
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Multinational Observational Database Study on Imminent Osteoporotic Fracture Risk
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Daniel Prieto-Alhambra - Corresponding Applicant - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Bo Abrahamsen - Collaborator - University Of Southern Denmark
Emese Toth - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Gary Collins - Collaborator - University of Oxford
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sara Khalid - Collaborator - University of OxfordOutcomes: none known
Description: Technical Summary
Background: Existing prediction models reliably estimate 10-year fracture probability, but might fail to identify subgroups at imminent fracture risk.
Aim/s: 1.To characterise patients at imminent fracture risk, and to calculate their 1- and 2-year fracture and mortality rates; 2.To assess the performance of QFracture(1) for 1- and 2-year fracture prediction in these subgroups.
Methods:
-Data sources: CPRD linked to HES-ONS.
-Study population: All CPRD participants in 1995-2016, age 50+ with 1+ year run-in in any of the following:
1. Newly diagnosed osteoporosis
2. Incident fracture (any but face/skull/digits)
3. Incident use of oral bisphosphonate/s (OBP)
4. Incident fracture while on OBP treatment
5. Completers of 3 years of OBP with >80% compliance
6. Completers of 5 years of OBP with >80% compliance
NOTE: These six cohorts will be analysed separately, as patients are eligible to be present in more than one of them.
-Outcomes: 1.Incident major fracture/s (hip, spine, non-hip non-spine, hip/humerus/wrist); 2.Fatal fractures; 3.Fracture-related hospitalization; 4.All-cause mortality.
-Exposure/s (risk factor/s): Risk factors included in QFracture(1) and FRAX, predictors of fracture while on treatment(2) and predictors of imminent fracture risk.
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Incidence and prevalence of nontuberculous mycobacterial pulmonary disease (NTMPD) in the UK since 2004 — Jennifer Quint ...
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Incidence and prevalence of nontuberculous mycobacterial pulmonary disease (NTMPD) in the UK since 2004
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-06
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Chloe Bloom - Collaborator - Imperial College London
Eleanor Axson - Collaborator - Imperial College LondonOutcomes:
(Non-tuberculous mycobacterium) NTM incidence; NTM prevalence.
Description: Technical Summary
The objective of this project is to explore the epidemiology (incidence and prevalence), of non-tuberculous mycobacterial pulmonary disease (NTMPD) in the general population and then specifically in people with bronchiectasis or COPD. This study will be undertaken using CPRD Vision data initially and then a sensitivity analysis will be undertaken using CPRD Vision linked with HES (hospital episode statistics) inpatient data to help us understand where and how infection is being recorded.
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Prevalence and incidence of dementia diagnosis in patients with and without chronic kidney disease in the UK — Dorothea Nitsch ...
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Prevalence and incidence of dementia diagnosis in patients with and without chronic kidney disease in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Corresponding Applicant - University of Tsukuba
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Collaborator - University of Tsukuba
Rikako Hiramatsu - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
We will compare the prevalence and incidence of dementia diagnosis between patients with and without chronic kidney disease (CKD). We will use a cohort of 242,349 matched pairs with and without CKD (estimated glomerular filtration rate <60 mL/min/1.73m2 twice for >3 months) for age, sex, general practice and calendar time between 2004 and 2014 in CPRD linked to Hospital Episode Statistics, which was established in our ongoing study (protocol 15_219RA). For prevalence, we will look at the dementia diagnosis recorded anytime after CPRD registration to the cohort entry (i.e. date of satisfying CKD definition for patients with CKD, and the same date for matched patients without CKD). For incidence, after excluding patients with prevalent dementia, we will compare the rate of a newly diagnosed dementia between patients with and without CKD. We will adjust for confounding factors including smoking and socio-economic status, care home residence, BMI, and comorbidities such as diabetes and cardiovascular diseases in the logistic regression analysis for prevalent dementia and Poisson regression analysis for incident dementia. We will also conduct subgroup analyses by dementia type (vascular dementia or Alzheimerâs disease), by CKD stage among patients with CKD, and by frequency of creatinine measurement among patients without CKD.
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Can CHA2DS2-VASc score be used to identify patients under 65 years old at high risk of atrial fibrillation? — Duncan Edwards ...
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Can CHA2DS2-VASc score be used to identify patients under 65 years old at high risk of atrial fibrillation?
Datasets:GP data, Patient Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-17
Organisations:
Duncan Edwards - Chief Investigator - University of Cambridge
Silvia (Silva) Mendonca - Corresponding Applicant - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Jenny Lund - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of CambridgeOutcomes:
Atrial fibrillation incidence rate; CHA2DS2-VASc score.
Description: Technical Summary
Untreated atrial fibrillation (AF) is associated with a five-fold increase in the risk of stroke. While age is a key determinant of AF, about 20% of AF occurs in people under the age of 65. Younger individuals experiencing stroke will lose more years of healthy life than older individuals, and therefore may benefit more from AF detection. However fewer young patients will have the diagnosis and not all of these will benefit from stroke prevention therapy, so there is still uncertainty about the benefit of screening people under 65 for AF. Additionally, there is value in determining whether information contained in GP medical records could be used to target high risk people in younger age groups in a potential screening programme. We propose two retrospective cohort studies. Cohort (i) will include all AF incident cases at any time and will be used to calculate AF incident rates, calculate the patient's cardiovascular risk at diagnosis (using CHA2DS2-VASc risk score) and examine how this risk varies over time. Cohort (ii) will be random sample of people under 65 years between 2004 and 2016 that will be used to calculate AF incidence rates stratified by cardiovascular risk.
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Seizure frequency and resource utilisation associated with initiation of perampanel, eslicarbazepine and rufinamide in patients with epilepsy — Christopher Morgan ...
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Seizure frequency and resource utilisation associated with initiation of perampanel, eslicarbazepine and rufinamide in patients with epilepsy
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-24
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Healthcare resource use; Frequency of adverse event; Healthcare costs; Seizure frequency.
Description: Technical Summary
A retrospective cohort study using CPRD GOLD will be conducted. Data from HES inpatient, outpatient and accident and emergency datasets and the patient level Townsend score will be utilised in a sensitivity analysis in patients eligible for linkage. Acceptable patients, registered at an up-to-standard practice will be included in the study if they have received a prescription for perampanel, eslicarbazepine or rufinamide from 2008 onwards and have a first prescription for a study drug recorded in CPRD GOLD >365 days after their date of registration. The baseline characteristics of the cases and the frequency of prescriptions for the study drugs will be described. Cases will be matched by propensity score to one control patient with the same epilepsy syndrome, seizure type and concomitant antiepileptic drug(s) initiating an antiepileptic therapy recommended at the same point in the treatment pathway. Frequency of seizures and adverse events and number of antiepileptic regimen changes will be compared prior to and post initiation and between cases and controls. Standard published NHS healthcare costs will be attributed to healthcare resource use. Healthcare resource use and the associated costs will be compared using the Wilcoxon signed rank test.
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Steroid Use and the risk of Venous Thromboembolism in Asthma Patients — Susan Jick ...
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Steroid Use and the risk of Venous Thromboembolism in Asthma Patients
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-17
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Lade Ayodele - Corresponding Applicant - Decision Resources GroupOutcomes:
Incident Venous Thromboembolism.
Description: Technical Summary
Venous thromboembolism (VTE) continues to pose an important disease burden, however a lot remains unknown about the risk factors that cause it. In recent years, attention has been focused on medications that play a role in development of drug-induced VTE. A significant proportion of the adult population receives steroids for ongoing management of asthma, therefore, potential serious adverse consequences of these treatments should be investigated. This will be a nested case control study among a population of people with asthma who received at least one steroid prescription during 1995- 2015 in the UK-based CPRD. Cases of VTE (pulmonary embolism [PE] or deep venous thrombosis [DVT]), and 4 matched controls for each case will be derived from the base population. We will assess the risk of VTE in relation to timing of drug exposure, duration of use and types of steroids. Descriptive analyses as well as conditional logistic regression will be used to evaluate the relationship between steroid use and the risk of VTE. The proposed study in a large population-based database of high quality will efficiently evaluate the safety of this pharmacologic agent, which will guide the development of guidelines for the use of steroids in prolonged care of asthma.
Source - and 23 more projects — click to show
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Clinical profile of pre-defined asthma phenotypes in a large cohort of UK primary care patients (CPRD). — Jennifer Quint ...
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Clinical profile of pre-defined asthma phenotypes in a large cohort of UK primary care patients (CPRD).
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-31
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Francis Nissen - Corresponding Applicant - Roche
Chloe Bloom - Collaborator - Imperial College London
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Neil Pearce - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Asthma exacerbation rates, including asthma hospitalizations and ER visits; Asthma medication use (BTS step); Pre-defined comorbidities: (Atopy, COPD, Gastro-oesophageal reflux disease, Nasal polyps, Sleep Apnoea, Anxiety, Depression).
Description: Technical Summary
Clinical phenotypes of asthma in primary care have been established using cluster analysis by Haldar et al. in a small primary care trial population. It is not known whether these phenotypes exists in a large cohort of primary care patients. The objective of this study is to classify the asthma patients into predefined phenotypes, and assess their clinical profile, medication use, comorbidities and health-care resource utilization and enumerate their rate of asthma exacerbations during follow-up and compare with existing data from clinical cohorts. In order to do this, we will assign asthma patients in CPRD GOLD a phenotype; the pre-defined phenotypes in primary care are 'Benign asthma', 'Atopic asthma', 'Obese non-eosinophilic asthma' and 'Asthma Not Otherwise Specified'. We will use blood eosinophil counts, asthma severity and additional phenotype-specific criteria as defining criteria for the phenotypes. Thus, we will be able to describe the profile of the asthma patients including demographic criteria, comorbidities and treatment step as defined by the BTS guidelines. The frequency of asthma exacerbations in each phenotype will be studied using Poisson regression to control for potential confounders. As novel asthma treatments aim to target clinical phenotypes, it is important to understand their occurrence using real world evidence.
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Multi-database imputation to adjust for confounders within distributed data drug safety networks â a methodological study using real-world data from the UK Clinical Practice Research Datalink — Samy Suissa ...
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Multi-database imputation to adjust for confounders within distributed data drug safety networks â a methodological study using real-world data from the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-17
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Andrea Benedetti - Collaborator - Research Institute of the McGill University Health Centre
Colin Dormuth - Collaborator - McGill University
Matthew Secrest - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
The primary study outcome will be time to fatal or nonfatal MI, excluding perioperative MIs. Outcomes will be ascertained using the HES and ONS, with the earliest code date as the event date. MIs determined in-hospital will be considered events if they occur in the primary or secondary position. Patients who have codes related to perioperative MIs will be censored from further study without signalling a study outcome.
Description: Technical Summary
Confounders such as smoking history, BMI, and laboratory values are not always captured by databases used in distributed data drug safety networks. Data access restrictions preclude traditional missing data techniques in these settings. We propose a method called âmulti-database imputationâ to correct for bias introduced when some databases are missing confounders. Our method leverages the âvalidationâ databases that capture the confounders of interest to generate posterior predictive distributions from which values are sampled for multiple imputation in the other, âmissingâ databases. We will demonstrate our methodâs utility by estimating the effect of statins on myocardial infarction (MI) among patients with type 2 diabetes. We will identify a population of patients with newly-treated type 2 diabetes without cardiovascular disease (CVD) or recent history of statin use in the CPRD linked to the Hospital Episode Statistics (HES) and Office of National Statistics (ONS) databases. Patients will be divided into âvalidationâ or âmissingâ databases based on geographic region. In the âmissingâ databases, smoking status, BMI, HbA1c, and serum cholesterol levels will be ignored. We will compare meta-analysed hazard ratios (HRs) for the effect of current statin use on MI with and without imputation of missing values using Cox models adjusted for baseline confounders.
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Understanding clinical and healthcare predictors of diagnostic timeliness in patients with suspected cancer — Yin Zhou ...
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Understanding clinical and healthcare predictors of diagnostic timeliness in patients with suspected cancer
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Yin Zhou - Chief Investigator - University of Cambridge
Yin Zhou - Corresponding Applicant - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Efthalia (Lina) Massou - Collaborator - University of Cambridge
Fiona Walter - Collaborator - University of Cambridge
Frank Corvino - Collaborator - Genesis Research LLC
Garth Funston - Collaborator - University of Cambridge
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Hannah Higgins - Collaborator - University of Cambridge
Kirsten Arendse - Collaborator - University of Cambridge
Marie Moullet - Collaborator - University of Cambridge
Marije van Melle - Collaborator - University of Cambridge
Sam Merriel - Collaborator - University of Exeter
Silvia (Silva) Mendonca - Collaborator - University of CambridgeOutcomes:
Health care diagnostic interval (from time of presentation to diagnosis); Primary care interval (from time of presentation to referral).
Description: Technical Summary
Timely diagnosis is important for clinical outcomes including survival, patient experience and health system efficiency. While we know that variations in biological, patient and healthcare factors may contribute to a later diagnosis when treatment with curative intent is not possible, relatively little is known about how they do so and the responsible mechanisms that may be amenable to interventions. Examining patterns of variation in healthcare events and treatments before a diagnosis is made can highlight inequalities in current clinical practice that may represent missed diagnostic opportunities. We will first study patterns of pre-diagnostic events including symptoms, primary and related specialist tests, referrals and primary care prescriptions for a range of common cancers. Using quantile regression, we will then examine how pre-diagnostic events are associated with the total healthcare (time of first presentation with a relevant symptom to diagnosis) and primary care (time from first presentation to referral) intervals. Our findings will inform the development of targeted interventions aimed to improve timely diagnosis of cancer.
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Systemic sclerosis in the UK: what is the disease burden and are there associations with other serious health outcomes? — Anita McGrogan ...
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Systemic sclerosis in the UK: what is the disease burden and are there associations with other serious health outcomes?
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-17
Organisations:
Anita McGrogan - Chief Investigator - University of Bath
Anita McGrogan - Corresponding Applicant - University of Bath
Alison Nightingale - Collaborator - University of Bath
John Pauling - Collaborator - Royal National Hospital For Rheumatic Diseases
Julia Snowball - Collaborator - University of Bath
Neil McHugh - Collaborator - University of BathOutcomes: none known
Description: Technical Summary
This study will investigate the incidence and prevalence of systemic sclerosis (SSc) in the UK. Cohort studies will be used to investigate serious outcomes: people with SSc will be matched to those who do not have SSc by age, sex, GP practice and calendar time will be accounted for. The outcomes investigated in separate studies will be cancer, myocardial infarction, cerebrovascular disease, peripheral vascular disease and pulmonary hypertension. Time to diagnosis of these outcomes and death will be compared using survival analysis. Covariates including smoking, alcohol, BMI, comorbidities and co-prescribing will be adjusted for.
The temporal relationship between cancer and SSc is less well understood than in other diseases: in some patients cancer pre-dates the diagnosis of SSc and this could be a factor in the development of SSc. This will be investigated using a case control study where the cases have an incident diagnosis of SSc and the controls do not, cases and controls will be matched as before. The analysis will use logistic regression and backdating of the index date to investigate this further. Where patients have a diagnosis of cancer and SSc at similar time points, inclusion in the analytical studies may not be possible.
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Persistence and compliance to anti-osteoporosis medications in the United Kingdom — Jason Morley ...
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Persistence and compliance to anti-osteoporosis medications in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-05
Organisations:
Jason Morley - Chief Investigator - Amgen Ltd
Andrew Taylor - Corresponding Applicant - Amgen Ltd
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Jonathan Bayly - Collaborator - University of Derby
Lisa Hamilton - Collaborator - Amgen Ltd
Maurille Feudjo Tepie - Collaborator - Amgen LtdOutcomes:
Estimate persistence to osteoporosis therapies between 2010-2015 (all patients); Estimate refill compliance to osteoporosis therapies between 2010-2105 (across all patients);
Estimate persistence and refill compliance to osteoporosis therapies in treatment-naive patients and non-naive treated patients.Description: Technical Summary
We aim to evaluate persistence, time to discontinuation, and refill compliance to osteoporosis therapies in post-menopausal women (including premature or surgery-induced menopause) who received at least one prescription for any licensed medication between 2010 and 2015. Patients with history of cancer or metabolic bone disease and insufficient baseline and follow-up data will be excluded. The primary objective of the study will be to estimate the persistence and refill compliance of osteoporosis therapies (both oral and parenteral) over 6, 12, 18, 24 month follow-up periods. Kaplan-Meier methods will be used to estimate time to discontinuation. Persistence will be estimated as the proportion of patients refilling each subsequent prescription within the grace period every 6 months. Compliance is quantified using the Medication Possession Ratio for oral therapies and medication coverage ratio for parenteral therapies. Secondary objectives will be to estimate adherence measures in postmenopausal women who are treatment-naive and non-naive treated. Outcomes will be assessed for the entire study population and for each of the cohorts of interest. All summaries of the data will be descriptive in nature. We will also present effects of various patient characteristics on the persistence and compliance outcome (e.g. age groups, comorbidities, prior therapies, and concomitant medications).
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Renal function and prescribing patterns of DPP-4 inhibitors in the UK: The extent of regional variation, dose adjustment and therapy switching. — Kamlesh Khunti ...
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Renal function and prescribing patterns of DPP-4 inhibitors in the UK: The extent of regional variation, dose adjustment and therapy switching.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Brendan Barrett - Collaborator - Boehringer-Ingelheim - UK
Chris D Poole - Collaborator - Digital Health Labs Limited
Toni Roman - Collaborator - Eli Lilly & Co - UKOutcomes:
Amongst patients with moderate or severe renal impairment initiating on a higher than the recommended DPP-4 inhibitor dose for the level of their renal function): Counts and percentage of patients who have their DPP-4 inhibitor dose adjusted or switch to another, appropriate DPP-4 inhibitor therapy overtime; (As above) KM curves (time to event) for dose adjustment/DPP-4 inhibitor therapy switching; Amongst patients with no renal impairment who initiate on the high dose of a DPP-4 inhibitor: Counts and percentage of patients who have their therapy changed or switched when their renal function is reduced to a level where therapy switch/dose adjustment is required; Counts and percentage of inappropriate prescribing of DPP-4 inhibitors in CPRD defined regions across the UK.
Description: Technical Summary
DPP-4i drug class is indicated for the glycaemic control in patients with T2DM. According to the Summary of Product Characteristics (SmPC), Saxagiptin, Sitagliptin, Alogliptin and Vildagliptin require dose adjustments for patients with certain level of impaired renal functionality. Linagliptin, being available in only one dose of 5mg, is the only drug of the class which does not require dose adjustments in relation to patients' renal function as is not excreted via the kidneys. A recent CPRD study, however, demonstrated that 42% of T2DM patients with moderate to severe renal impairment initiated on a DPP-4i (except linagliptin) were on a higher than the recommended dose for the level of their renal function. Adopting a retrospective cohort study design, the primary objective of this proposal is to examine patterns of dose adjustment and therapy switching occurring within DPP-4i class amongst T2DM patients with moderate or severe renal impairment initiating on a higher than the recommended DPP-4i dose for the level of their renal function, as well as among T2DM patients with no renal impairment who have subsequently their renal function reduced to levels where dose adjustment is required. Moreover, a secondary objective of this proposal is to provide insights about patterns of regional variation of inappropriate prescribing in the country based on a cross-section of data from the 13 UK regions available in CPRD. To address these objectives a number of analyses have been suggested. In the first analysis a cohort of T2DM patients with impaired renal function (expressed by an eGFR <60 ml/min/1.73 m2 or a clinical record indicating a stage 3/3a/3b/4/5 renal disease), who initiate on a high dose of a DPP-4i inhibitor will be followed up for at least 12 months and Kaplan Meier curves will be potted and descriptive statistics will be generated to describe dose adjustment and therapy switching in the cohort. High DPP-4i dose occurrence in this patient cohort will be also described on regional level according to the 13 CPRD UK defined regions. In addition, a cohort of T2DM patients with no evidence of renal impairment who initiate on a high dose of a DPP-4i but subsequently develop renal impairment will be characterised in terms of their post renal impairment DPP-4i prescription to assess the occurrence of dose adjustment/therapy switching.
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Effects of financially-induced inhaler switching on the risk of an acute exacerbation in patients with asthma or chronic obstructive pulmonary disease (COPD): a self-controlled case series — Jennifer Quint ...
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Effects of financially-induced inhaler switching on the risk of an acute exacerbation in patients with asthma or chronic obstructive pulmonary disease (COPD): a self-controlled case series
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-24
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Incident asthma exacerbations; Incident COPD exacerbations.
Description: Technical Summary
We will use CPRD linked with HES and ONS to conduct a self-controlled case series (SCCS) to measure the difference in the risk of an acute exacerbation, in patients with asthma or COPD, shortly after a switch of their usual inhaler instigated at their GP practice for technical reasons, compared to times when a switch has not been instigated. SCCS is suited to this current research question as there are precise timings available of a transient exposures (inhaler switch) and a non-recurrent event (first acute exacerbation during follow-up). The incidence rate ratio of acute exacerbations will be estimated comparing exposed periods (3 months following the inhaler switch) to unexposed periods (11 months before inhaler switch and 9 months after) in a conditional Poisson regression model. SCCS implicitly controls for time invariant confounders but time varying confounders will be controlled for in the analysis. We will investigate potential effect modification by disease type, severity of disease, and inhaler switch type by stratified analysis.
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Incidence of major bleeding events and ischaemic stroke among non-valvular atrial fibrillation patients in the UK — Farnaz Vahidnia ...
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Incidence of major bleeding events and ischaemic stroke among non-valvular atrial fibrillation patients in the UK
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-17
Organisations:
Farnaz Vahidnia - Chief Investigator - Roche
Nadia Foskett - Corresponding Applicant - UCB BioSciences, Inc.
Ameet Bakhai - Collaborator - Royal Free London NHS Foundation Trust
Fabian Wiktorowski - Collaborator - Roche
Frank Corvino - Collaborator - Genesis Research LLC
Hans Petri - Collaborator - Petri Consulting Ltd
Marcus Hibell - Collaborator - Roche
Mark John Sculpher - Collaborator - University of York
Matthew McEnany - Collaborator - Genesis Research LLC
Nadia Foskett - Collaborator - UCB BioSciences, Inc.
Yingjie Ding - Collaborator - Genesis Research LLCOutcomes:
Primary outcomes: Ischemic stroke; Major bleeding.
Secondary outcomes: Deaths; Fatal ischemic stroke; Fatal major bleeding.
.Description: Technical Summary
Study objective: to describe incidence of major bleeding events and ischemic stroke in a recent population of patients with non-valvular atrial fibrillation (NVAF) using UK CPRD linked to England Hospital Episode Statistics (HES). Methods: A retrospective cohort study among adult patients with newly diagnosed NVAF between Jan, 2011 - Dec, 2015 (or up to the most recent data available). The linked HES and ONS mortality data will be used to study ischemic stroke and major bleeding outcomes. Analysis: After describing baseline patients' characteristics, we will estimate crude, age, gender, calendar year specific incidence rates and their 95 % confidence intervals. The rates will be stratified by age, gender, ethnicity, calendar year of atrial fibrillation diagnosis, use of oral anticoagulants, stroke and bleeding risk at study entry, geographic area, deprivation and frailty. All-cause mortality and mortality from ischemic stroke and major bleeding will be estimated. Our study will present an up-to-date landscape of ischemic stroke and major bleeding events in an incident NVAF population.
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An evaluation of the epidemiology, burden of illness and financial costs of healthcare services for people with peanut allergy in the United Kingdom. — Craig Currie ...
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An evaluation of the epidemiology, burden of illness and financial costs of healthcare services for people with peanut allergy in the United Kingdom.
Datasets:GP data, HES Accident and Emergency; HES Accident and Emergency; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-26
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Laura Scott - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence of peanut allergy
- Prescribed treatment for peanut allergy
- NHS resource use and costs associated with peanut allergy
- Mortality and cause of death in peanut allergyDescription: Technical Summary
This study aims to calculate the difference in cost of healthcare services in those patients with and without peanut allergy. The objectives are to identify a population with peanut allergy and to describe the prevalence of the condition. We then wish to use a retrospective matched cohort design to evaluate the impact of peanut allergy on healthcare resource use and cost, mortality, and the prevalence of other allergies and atopic conditions. We will also characterize the use of adrenaline and antihistamine therapies for peanut allergy.
Peanut allergy will be identified from CPRD GOLD and HES inpatient data, and patients with peanut allergy will be matched 1:1 with two reference groups of non-exposed patients. The first reference group will be matched on age, sex, practice, year of registration, and linkage status; the second on the same criteria plus atopic status.
Comparisons of rates and costs of health services between cohorts will use Mann-Whitney U-test. Time to death for patients with peanut allergy compared to reference cohorts will be compared using a Cox proportional hazards model. Annual prevalence rates for peanut allergy will be split by age and gender, using the number of research-quality patients registered at each year's midpoint as the denominator. A table of causes of death and prescriptions will be presented non-comparatively.
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Eligibility for blood pressure lowering treatment and subsequent cardiovascular disease burden under four different treatment approaches: a cohort study — Emily Herrett ...
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Eligibility for blood pressure lowering treatment and subsequent cardiovascular disease burden under four different treatment approaches: a cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-23
Organisations:
Emily Herrett - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Adam Timmis - Collaborator - Queen Mary University of London
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Reecha Sofat - Collaborator - University College London ( UCL )
Rod Jackson - Collaborator - University of Auckland
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Eligibility for blood pressure lowering treatment; Cardiovascular disease.
Description: Technical Summary
The current approach to blood pressure treatment in the UK relies predominantly on blood pressure thresholds. This ignores evidence showing that treatment lowers cardiovascular disease (CVD) risk at all blood pressures, with no threshold. One alternative treatment approach would be to use a threshold of overall CVD risk, a strategy that is now accepted for lipid lowering drugs. Another suggested approach is to use age and sex to determine treatment. To help decide on the optimal strategy for population health, there are two key considerations: the number of patients who would be eligible for treatment under each strategy, and whether the strategy prioritises treatment to patients with the highest future burden of CVD. This protocol describes a cohort study to investigate eligibility for blood pressure lowering treatment under four different approaches (i) current NICE guideline, (ii) blood pressure alone (to reflect evidence that some GPs are ignoring the NICE guideline), (iii) cardiovascular risk, and (iv) age/sex. Beginning in 2011, the cohort will be split according to treatment eligibility under each strategy, and followed up for their first cardiovascular disease event. Rates and proportions of events, according to treatment eligibility, will be reported.
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Epilepsy in the elderly: optimising care for a growing, yet critically under-recognised, population — Colin Josephson ...
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Epilepsy in the elderly: optimising care for a growing, yet critically under-recognised, population
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-24
Organisations:
Colin Josephson - Chief Investigator - O'Brien Institute for Public Health & Hotchkiss Brain Institute
Colin Josephson - Corresponding Applicant - O'Brien Institute for Public Health & Hotchkiss Brain Institute
Ana Subota - Collaborator - University of Calgary
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Jordan Engbers - Collaborator - Desid Labs, Inc.
Maria Pikoula - Collaborator - University College London ( UCL )
Mark Keezer - Collaborator - Centre Hospitalier de l'Universite de Montreal
Marta Berglund - Collaborator - University College London ( UCL )
Nathalie Jette - Collaborator - University of Calgary
Samuel Wiebe - Collaborator - University of Calgary
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
The incidence of epilepsy has almost quintupled over the past 40 years likely due to longer lifespans and the consequent accumulation of medical conditions that predispose to recurrent seizures. Despite this, epilepsy in the elderly remains a remarkably underexplored condition. Epilepsy itself is associated with increased risks for heart disease, osteoporosis, mental health disorders, and death. These risks are reasonably expected to be even higher for the elderly. Hence, we propose using age 65, a data-driven empirical definition of elderly with epilepsy, to study this issue. Multiple analyses will be performed on independent cohorts. First, we will isolate all those over the age 65 and perform multivariate Cox regression analyses, using epilepsy diagnosis as the exposure and treating it as a time-varying covariate, to determine the hazard of a variety of somatic and psychiatric conditions in relation to incident epilepsy. We will then replicate this analysis using all-cause and cardiac-specific death as outcomes controlling for known confounders and the potential effect of enzyme-inducing antiepileptic drugs. We will then perform similar analyses, using age 65 as the index date, to determine the influence of prevalent epilepsy (accumulated risk) on the same outcomes and mortality.
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Cancer-related Mortality in Type 2 Diabetes: A Population-Based Cohort Study Quantifying Relationships with Body Mass Index using Linked Electronic Health Records — Darren Ashcroft ...
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Cancer-related Mortality in Type 2 Diabetes: A Population-Based Cohort Study Quantifying Relationships with Body Mass Index using Linked Electronic Health Records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Nasra Alam - Corresponding Applicant - University of Manchester
Alison Wright - Collaborator - University of Manchester
Andrew G Renehan - Collaborator - The Christie NHS Foundation Trust
Iain Buchan - Collaborator - University of Manchester
Martin Rutter - Collaborator - University of Manchester
Matthew Sperrin - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
This application is a direct extension of an already captured matched cohort study of patients registered with diabetes in CPRD (protocol: 15_123Mn)
In the above study (Wright et al. Diabetes Care 2017;40:1-8), there were 187,968 patients with incident type 2 diabetes, T2D, (1998 to 2015) matched to 908,016 control subjects. Deaths were captured through linkage with Official of National Statistics.
Overall mortality was twofold greater among patients with T2D compared with those without diabetes. The commonest cause of increased mortality was circulatory disease (15.9 per 1000 py versus 6.4 per 1000 py); the second commonest cause was malignant neoplastic disease (11.0 per 1000 py versus 5.8 per 1000 py).
We will deeply phenotype the associations between T2D and the observed increased cancer-related mortality and explore the hypothesised central role of excess weight â approximated as body mass index (BMI).
We will use Cox proportional hazard models, stratified by matching group, to estimate hazard ratios and test that the higher cancer death rate among patients with T2D is due to deaths from obesity-related cancers (13 cancer types). And second, among patients with T2D, test that increasing BMI (determined in the peri-diagnosis of diabetes period) is related to increasing deaths from obesity-related cancers.
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The association between glycated haemoglobin (HbA1c), glycaemia and chronic kidney disease with or without anaemia. — George Savva ...
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The association between glycated haemoglobin (HbA1c), glycaemia and chronic kidney disease with or without anaemia.
Datasets:GP data, ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-17
Organisations:
George Savva - Chief Investigator - University of East Anglia
Stamatina Maria Cheilari - Corresponding Applicant - University of East Anglia
Emma English - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East Anglia
Paul Wisdom - Collaborator - University of East Anglia
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Primary Outcomes: The validity of glycated haemoglobin (HbA1c ) as a measure of glycaemia in patients with CKD with or without anaemia Chronic kidney disease (CKD) incidence and progression Secondary outcomes: Cardiovascular (CVD) mortality conditional on HbA1c and CKD stage Mortality from other non-CVD causes conditional on HbA1c and CKD stage
Description: Technical Summary
The primary aim of this study is to understand how glycaemic control, measured by HbA1c predicts trajectories of chronic kidney disease (CKD), among patients with non-diabetic hyperglycaemia (HbA1c of 42-47mmol/mol) or with newly diagnosed type 2 Diabetes Mellitus (T2DM) (HbA1c of 48mmol/mol or greater). Although the relationship between HbA1c and renal outcomes is well described for patients with established T2DM, precise monitoring thresholds or ranges that would indicate lower progression rates of kidney failure is not known. Hence, a retrospective cohort study to assess this issue will be used: patients will enter the study at the first time at which HbA1c is measured at or above 42mmol/mol and will leave upon censoring, or death. A continuous time multi-state model will estimate the transition rate between CKD stages during follow-up, and transition to "absorbing" states of mortality from cardiovascular diseases (CVD) or other causes from each stage. Estimating the effect of glycaemia on each transition probability is the primary objective.
The utility of HbA1c for the measurement of glycaemia and diagnosis of DM has been well described. Since the measurement of glycaemic control is known to be affected by CKD and associated complications such as anaemia, we will first test the validity of HbA1c as a measure of glycaemic control at different CKD stages among anaemic and non-anaemic patients. Hence, the validity of HbA1c will be assessed by using all available occasions where HbA1c tests are paired with a fasting plasma glucose (FPG), Full Blood Count (FBC), defined by Haemoglobin (Hb) index, and where CKD stage is known. Using a regression analysis of HbA1c on FPG and CKD we will estimate the effect of CKD stage measured by glomerular filtration rate (GFR) and test the effect of anaemia on the relationship between CKD, glucose and HbA1c.
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The association between chronic kidney disease and tuberculosis; a comparative cohort study in England — Dorothea Nitsch ...
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The association between chronic kidney disease and tuberculosis; a comparative cohort study in England
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-13
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Corresponding Applicant - University of Tsukuba
Judith Ruzangi - Collaborator - Imperial College London
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Punam Mangtani - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
We will compare the prevalence and incidence of tuberculosis diagnosis between patients with and without chronic kidney disease (CKD). We will use a cohort of 242,349 matched pairs with and without CKD (estimated glomerular filtration rate <60 mL/min/1.73m2 twice for >3 months) for age, sex, general practice and calendar time between 2004 and 2014 in CPRD linked to Hospital Episode Statistics, which was established in our ongoing study (protocol 15_219RA). For prevalence, we will look at the tuberculosis diagnosis recorded any time after CPRD registration to the cohort entry (i.e. date of satisfying CKD definition for patients with CKD, and the same date for matched patients without CKD). For incidence, after excluding patients with a history of tuberculosis, we will compare the rate of newly diagnosed tuberculosis between patients with and without CKD. We will adjust for confounding factors including smoking and socio-economic status, ethnicity, BMI, comorbidities (e.g. diabetes) and prescription of oral corticosteroids in the logistic regression analysis for a history of tuberculosis and Poisson regression analysis for incident tuberculosis. We will look for evidence of interaction by age and ethnicity.
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Comparison of Outcomes for Patients Hospitalised with Decompensated Heart Failure in the UK and Japan — Jennifer Quint ...
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Comparison of Outcomes for Patients Hospitalised with Decompensated Heart Failure in the UK and Japan
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-02
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Toshiyuki Nagai - Corresponding Applicant - Imperial College London
Varun Sundaram - Collaborator - Imperial College LondonOutcomes:
All-cause mortality; Length of hospital stay; Application rate of guideline-directed medical therapy.
Description: Technical Summary
As a national sample of current practice, we will use linked Clinical Practice Research Datalink (CPRD) data with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) to undertake a cohort study to provide an accurate estimate of the number of people with hospitalised heart failure in the United Kingdom (UK). Japanese data will be sourced from the 2012-2015 Nationwide Claim-Based Database, the Japanese Registry Of All cardiac and vascular Diseases - Diagnosis Procedure Combination (JROAD-DPC). Each cohort (UK and Japan) will be analysed separately. All-cause mortality and proportion of patients receiving guideline directed medical therapy will be determined using Cox regression models. Multivariable Cox regression analysis will be used to estimate differences after adjusting for covariates (age, sex, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, hypertension, coronary artery disease, atrial fibrillation, previous stroke, malignancy, obesity and depression). On completion of the analysis, pooled estimates will be compared across the datasets.
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The routine use of electronic healthcare record data to strengthen signal evaluation and early pharmacovigilance decision making in UK medicines regulation — Katherine Donegan ...
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The routine use of electronic healthcare record data to strengthen signal evaluation and early pharmacovigilance decision making in UK medicines regulation
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-25
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRA
Alexander Smith - Collaborator - MHRA
Brian Burch - Collaborator - MHRA
Helena Bird - Collaborator - MHRA
Philip Tregunno - Collaborator - MHRA
Rebecca Owen - Collaborator - MHRAOutcomes:
The analysis will be applied to all adverse events of interest using Read codes at a pre-specified level within the code hierarchy so that the outputs are accessible if needed. However, the decision about whether the analyses will be specifically accessed and reviewed for a specific product will be made on the basis of signals arising from other sources (e.g. Yellow cards) that are discussed at an expert advisory group. Sub-Read codes will be combined with their parent code. The three pre-identified case studies will focus on salivary hypersecretion, alopecia, and cognitive disorder. Custom groups for combining Read codes to better identify a number of adverse events commonly associated with drug exposure will be included in the analyses and, if such events feature in signals raised, will be accessed and reviewed.
Description: Technical Summary
Despite use of signal detection algorithms the assessment of causality using spontaneous adverse event reports is complicated by the limitations of such schemes, which are subject to under-reporting and which lack comparator data in unexposed patients meaning that the impact of any biases in reporting is unclear. There is likely to be a benefit in placing potential safety signals arising from such reports into the context of the size and characteristics of the treated population at an early stage to assist assessment and that electronic healthcare record data could enable this. This is done routinely in vaccine pharmacovigilance through the use of observed vs. expected analyses and methodological and logistical approaches have been developed facilitating wider adoption of this approach for all medicines. This study will explore when and how descriptive analyses of CPRD data can more routinely provide useful insights that will increase efficiency and/or scientific robustness of regulatory assessment regarding safety signals earlier in the pharmacovigilance cycle. Analyses will be conducted at a drug substance and Read code level for drug-event pairs raised as signals and will include descriptive analyses of patients initiating treatment and/or experiencing an adverse event including exploration of any temporal relationship using chronographs.
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Quantifying variation in UK primary care test use: A 15 year retrospective CPRD analysis of temporal and geographical variation in test use. — Rafael Perera ...
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Quantifying variation in UK primary care test use: A 15 year retrospective CPRD analysis of temporal and geographical variation in test use.
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-13
Organisations:
Rafael Perera - Chief Investigator - University of Oxford
Jack O'Sullivan - Corresponding Applicant - University of Oxford
Carl Heneghan - Collaborator - University of Oxford
Chris Salisbury - Collaborator - University of Bristol
Clare Bankhead - Collaborator - University of Oxford
Paul Little - Collaborator - University of Southampton
Richard Hobbs - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of Oxford
Toqir Mukhtar - Collaborator - Imperial College LondonOutcomes:
To determine the temporal change in test use in UK primary care from 2000 -2015; To examine changes in total test ordering in UK primary care from 2000-2015; To examine changes in use of 25 specific tests in UK primary care from 2000 -2015; To determine geographical differences in test use in UK primary care; To determine if geographical variation in total test use exists across the UK; To determine if geographical variation in use of 25 specific tests exists across the UK.
Description: Technical Summary
Over the last decade, the NHS has experienced an unprecedented spending rise, net expenditure has increased by over £50bn, an ~80% rise. Increasing expenditure threatens NHS sustainability. Primary care accounts for 90% of NHS contact, but is on the brink of 'saturation point'. A recent Lancet study recommends quantifying primary care test use workload (ISAC Protocol Number: 15_120R). We aim to determine temporal change in total test use (2000- 2015), temporal change in 25 specific tests and geographical differences in total and specific test use. Tests ordered for patients from UK general practices registered in the CPRD from April 1st 2000 to March 31st 2015 will be analysed. We will use joinpoint regression to quantify temporal changes in test use. Trends will be examined nationally and also compared across different geographical regions. Using the same methodology we will examine the temporal and geographical variation for 25 specific tests. This research will facilitate a greater understanding of primary care activity and help shape policy, resource allocation and budgeting. Our results will also lead to further research, particularly investigating explanations for temporal and/or geographical variation. The ultimate aim of this research is to contribute to the changes required to ensure the sustainability of the NHS.
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The associations between inFLAmmatory and non-inflammatory oral Mucosal diseases and hEad and Neck squamous Cell carcinOma (FLAMENCO). — Stefano Fedele ...
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The associations between inFLAmmatory and non-inflammatory oral Mucosal diseases and hEad and Neck squamous Cell carcinOma (FLAMENCO).
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-11
Organisations:
Stefano Fedele - Chief Investigator - University College London ( UCL )
Kununya Pimolbutr - Corresponding Applicant - Eastman Dental Institute
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Stephen Porter - Collaborator - University College London ( UCL )Outcomes:
PRIMARY OUTCOME
- The associations between the development of head & neck squamous cell carcinoma and oral diseases known to increase the risk of head & neck cancer (the diseases of interest) including: oral lichen planus, oral submucous fibrosis, leukoplakia, periodontal disease.
Outcome of interests will be:
- The incidence of head and neck squamous cell carcinoma
- Time to the first diagnosis of head and neck squamous cell carcinoma
- The associations with traditional risk factors for head & neck squamous cell carcinoma including smoking and alcohol.SECONDARY OUTCOME
- The prognosis of head & neck cancer in patients with a history of the above cancer- predisposing oral diseases vs those without an history of these conditions, as expressed by:
1. Overall survival rates and disease-specific survival rates
2. Stage of first HNC
3. Stage of subsequent HNC
4. The number of additional head & neck cancer events following the first malignant episode
5. The treatment received (surgery, chemotherapy and/or radiotherapy)
6. The number of inpatient admissions
7. The number of outpatient appointments
8. The development of radiotherapy-induced jaw osteonecrosis
9. The development of radiotherapy-induced soft tissue fibrosis (trismus and dysphagia)Description: Technical Summary
We aim to assess the associations between oral lichen planus (OLP), oral submucous fibrosis (OSF), leukoplakia (LK) and periodontal diseases (PD), and the development of head and neck cancer (HNC) in a representative sample of the UK population using electronic health records from primary and secondary health care databases during 1997 to 2014. The hazard ratios (HR) of HNC among patients with/without the diseases of interest will be calculated using Cox proportional hazard models adjusted for potential confounding factors. We shall also consider the role of age, gender, medications, and other specific underlying diseases as effect modifiers.
With respect to the impact of these common oral disorders upon cancer prognosis, we plan to study survival rates by using Kaplan-Meier methods. Moreover, we will assess long-term cancer behaviour through the analysis of a number of additional prognostic markers/surrogates including (i) number of additional malignant events after the first diagnosis of HNC (new primary cancers), (ii) the total number of outpatient visits, (iii) the total number of inpatient admissions, (iv) the treatments received, and (v) the development of complications of anti-cancer therapy (fibrosis, dry mouth and jaw osteoradionecrosis).
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Count of hospital admissions due to Influenza and Respiratory Syncytial Virus by year of birth and severity, England, 2010-2016 — Iain Gillespie ...
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Count of hospital admissions due to Influenza and Respiratory Syncytial Virus by year of birth and severity, England, 2010-2016
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-05
Organisations:
Iain Gillespie - Chief Investigator - GlaxoSmithKline - UK
Iain Gillespie - Corresponding Applicant - GlaxoSmithKline - UK
Joe Maskell - Collaborator - Amgen Ltd
John Logie - Collaborator - GlaxoSmithKline - UKOutcomes: none known
Description: Technical Summary
This study seeks to generate counts, by age and length of admission, of patients admitted to hospital with influenza or RSV in England between 2010 and 2016. Counts will be split further by the primary nature of the hospital admissions (e.g. flu or RSV respectively was recorded as the primary reason for hospital admission), the incident nature of the hospital admissions (e.g. if a patients had previous admissions in the 90 days prior to each admission) and whether patients were admitted to intensive care units or were mechanically ventilated. The data will also be stratified by the need for critical care and mechanical ventilation.
This study seeks to describe the relationship between age and the risk of hospital admission for influenza and RSV, and on the relationship between age and severity. No formal testing of these relationships will be undertaken
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Investigating the impact of the introduction of a named GP assigned to patients 75 and over on their continuity of care and emergency hospital admission — Peter Tammes ...
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Investigating the impact of the introduction of a named GP assigned to patients 75 and over on their continuity of care and emergency hospital admission
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Other; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-24
Organisations:
Peter Tammes - Chief Investigator - University of Bristol
Peter Tammes - Corresponding Applicant - University of Bristol
Chris Salisbury - Collaborator - University of Bristol
Fiona MacKichan - Collaborator - University of Bristol
Richard Morris - Collaborator - University of Bristol
Rupert Payne - Collaborator - University of Bristol
Sarah Purdy - Collaborator - University of BristolOutcomes:
Continuity of primary care; GP referrals and admission through A&E.
Description: Technical Summary
National Health Service Employers and General Medical Services agreed to introduce from mid-2014 a named accountable GP for all patients aged 75+. This study aims to investigate whether this intervention 1) improved patients' continuity of care and 2) decreased their risk of emergency hospital admission. This cohort study obtains a random sample of 30,000 patients aged between 65-85 in 2012 from the Clinical Practice Research Datalink (CPRD), who were registered with their practice at least one year prior to 2012 and who were alive in 2014. The CPRD is linked with Hospital Episode Statistics showing emergency hospital attendance and admissions. Patients will be followed between April 2012-April 2016, comprising a two-year period before and after the intervention. As a patient's continuity of care and emergency hospital admission will be measured in the pre-intervention and post-intervention period, this study uses a multilevel model to analyse repeated measurements over time (within patients) whereby time-period is level-1, patients is level-2, and general practices is the level-3 unit. A mediation analysis, adjusted for confounders at the individual and practice level, will test the hypothesised causal chain in which a named GP improves continuity of care that, in turn, decrease risk of emergency hospital admission.
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Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU — Helga Gardarsdottir ...
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Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-24
Organisations:
Helga Gardarsdottir - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
Hendrika van den Ham - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht UniversityOutcomes:
Incidence of major bleeding; Duration of use; Persistence; Switching; Drug-interactions.
Description: Technical Summary
Since the introduction of the direct oral anticoagulants (DOACs) there are still some uncertainties around the effectiveness and safety compared to vitamin K antagonists (VKAs), especially with the respect to bleeding within specific subgroups. This study is undertaken to 1) assess the safety of the DOACs compared to VKAs in (subgroups of) patients with non-valvular atrial fibrillation (NVAF) in a real-world setting, 2) describe the utilization of DOACs in the EU for treatment of NVAF, and 3) describe prescribers' compliance with recommendations made in the summary of product characteristic for each DOAC. Methods The base population will consist of all (D)OAC users between 2008-2015. Three studies will be conducted to answer the research questions listed under objectives. One retrospective cohort study (objective 1) and two descriptive studies (objective 2&3). For the descriptive studies number of patients and percentages will be reported. Baseline characteristics will be summarized as means and standard deviations or proportions where appropriate. Crude incidence rates of outcomes per 1,000 person years will be estimated, stratified by sex and age groups. Cox proportional hazard regression analysis will be applied to estimate bleeding risk (adjusted hazard ratios, HR) of (D)OAC treatment.
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Impact of the definition of osteoarthritis and the timing of its onset on the association between type 2 diabetes mellitus and osteoarthritis: Clinical Practice Research Datalink. — Frank de Vries ...
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Impact of the definition of osteoarthritis and the timing of its onset on the association between type 2 diabetes mellitus and osteoarthritis: Clinical Practice Research Datalink.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-19
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Anna Elise (Annelies) Boonen - Collaborator - Maastricht University Medical Centre
Bart JF van den Bemt - Collaborator - Sint Maartenskliniek
Johannes T.H. Nielen - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Pieter Dagnelie - Collaborator - Maastricht UniversityOutcomes:
A diagnosis of knee osteoarthritis; A diagnosis of hip osteoarthritis; Total knee replacement; Total hip replacement.
Description: Technical Summary
Several studies have proposed that type 2 diabetes mellitus (T2DM) may be an independent risk factor for osteoarthritis (OA). As it is unknown whether a diagnosis of OA is well recorded, total joint replacement (TJR) is commonly used as a proxy of OA in epidemiological studies. However, the reliability of TJR as a proxy has never been examined. The use of TJR may introduce bias due to confounding by disease severity, as severe T2DM patients may not undergo elective surgery due to contraindicating comorbidities. We therefore aim to compare different definitions (e.g. diagnosis of OA and TJR) of OA, while examining the association between T2DM and OA. All patients who received their first prescription of a non-insulin antidiabetic drug (NIAD) will be selected as T2DM patient. Each T2DM patient will be matched to one patient without a NIAD in the entire follow-up. Cox proportional hazard models will be used to estimate the risk of the outcomes. Additionally, an OA diagnosis shortly after onset of T2DM may not reflect the actual date of onset of the disease and could result in biased estimates. Therefore, additional analyses will be conducted adding a latency period up to 10 years after first NIAD prescription.
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Impact of methods for measuring the prevalence and incidence of chronic disease in the UK population based on electronic medical record (EMR) data — Dorothee Bartels ...
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Impact of methods for measuring the prevalence and incidence of chronic disease in the UK population based on electronic medical record (EMR) data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-07-13
Organisations:
Dorothee Bartels - Chief Investigator - Boehringer-Ingelheim Germany
Dorothee Bartels - Corresponding Applicant - Boehringer-Ingelheim Germany
Jeremy Rassen - Collaborator - Aetion, Inc
William Murk - Collaborator - Aetion, IncOutcomes:
Cystic fibrosis; Psoriasis; Inflammatory bowel disease; Chronic obstructive pulmonary disease; Schizophrenia.
Description: Technical Summary
This study will investigate how different methodological assumptions of measuring prevalence and incidence may affect the observed prevalence and incidence of chronic disease in the CPRD database. Assumptions include how much time to look back to identify prevalent disease, different ways of calculating a denominator, and different ways of identifying incident cases. The prevalence and incidence observed under each set of assumptions will be compared with other measures of prevalence/incidence for the disease of interest in the UK, in order to determine a reasonable set of assumptions to apply in making these measurements in data such as CPRD. This will be performed for five different diseases, including cystic fibrosis, inflammatory bowel disease, schizophrenia, psoriasis, and chronic obstructive pulmonary disease. These diseases were selected as they have a range of different expected prevalences and incidences in the population, which will enable investigation into how the effects the methodological assumptions depend on the underlying prevalence/incidence. Incidence and prevalence will be estimated as proportions (expressed as percentages). Confidence intervals for proportions will be specified using the Wald method.
Source
2017 - 06
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Aromatase Inhibitors and Risk of Cardiovascular Disease in Post-Menopausal Women with Breast Cancer — Samy Suissa ...
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Aromatase Inhibitors and Risk of Cardiovascular Disease in Post-Menopausal Women with Breast Cancer
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-08
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Farzin Khosrow-Khavar - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Nathaniel Bouganim - Collaborator - McGill UniversityOutcomes:
Myocardial infarction; Congestive Heart Failure; Ischemic stroke; Cardiovascular associated mortality.
Description: Technical Summary
Aromatase inhibitors have replaced tamoxifen as the mainstay treatment of hormone-receptor positive breast cancer in post-menopausal women. However, randomized controlled trials indicate that these drugs are associated with increased risk of cardiovascular disease in comparison to tamoxifen. This signal warrants further investigation as cardiovascular disease was reported as a composite endpoint in randomized controlled trials and cerebrovascular events were reported infrequently in trial. Further, post-menopausal women represent a patient population already at increased risk of cardiovascular disease. The objective of this study will be to compare the risk of acute myocardial infarction, ischemic stroke, cardiovascular-associated mortality, and congestive heart failure between use of aromatase inhibitors and tamoxifen in post-menopausal women with diagnosis of breast cancer in clinical practice. We will define a cohort of patients newly diagnosed with breast cancer and compare risk of study outcomes between patients initiating treatment on AIs and tamoxifen. Patients with metastatic breast cancer, use of AIs before breast cancer diagnosis, and less than one year of medical history will be excluded. Exposure will be defined in a time-dependent manner with patients contributing person-time to use of AIs, tamoxifen, both, or none. Cox-proportional hazards model will be used to compare risk of study outcomes between use of AIs and tamoxifen adjusting for major confounders. This study will provide clinicians with strong evidence regarding the risk of serious cardiovascular and cerebrovascular event associated with aromatase inhibitors in the real-world setting.
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Resource utilization and cost of care for patients with atrial fibrillation following ablation vs antiarrhythmic medication — Abhishek Chitnis ...
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Resource utilization and cost of care for patients with atrial fibrillation following ablation vs antiarrhythmic medication
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Abhishek Chitnis - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Abhishek Chitnis - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
David Wei - Collaborator - Johnson & Johnson ( JnJ - USA )
Jamie L. March - Collaborator - Johnson & Johnson ( JnJ - USA )
Julian Jarman - Collaborator - Royal Brompton Hospital
Rahul Khanna - Collaborator - Johnson & Johnson ( JnJ - USA )
Ray P. Liao - Collaborator - Johnson & Johnson ( JnJ - USA )Outcomes:
Inpatient Admissions Outpatient visits Rate of direct current cardioversion Medications prescribed Stroke and transient ischemic attack Total cost of care
Description: Technical Summary
The objective of this retrospective longitudinal study is to evaluate one-year healthcare utilization and costs in AF among patients receiving ablation versus antiarrhythmic medications. Patients with AF will be identified and categorized as those receiving ablation versus those without ablation but receiving antiarrhythmic medications between 2010 and 2013. The outcomes of interest include number of inpatient admissions and outpatient visits, proportion of patients with rate medications, anticoagulant medication, and, and total cost of care after ablation or antiarrhythmic medications. The study will also compare the risk of stroke/transient ischemic attack (TIA) between ablation and antiarrhythmic medications. Analyses for this study will be both descriptive and comparative using multivariable models. The multivariable models will include generalized linear models based on the outcome variable of interest for utilization and costs. Also, a multivariable Cox regression model will be constructed for the time to stroke/TIA outcome..
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Development and validation of clinical prediction rules to help with decision making and early detection of multiple myeloma — Jason Oke ...
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Development and validation of clinical prediction rules to help with decision making and early detection of multiple myeloma
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-05
Organisations:
Jason Oke - Chief Investigator - University of Oxford
Constantinos Koshiaris - Corresponding Applicant - University of Oxford
Ann Van Den Bruel - Collaborator - University of Oxford
Brian Nicholson - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes:
Myeloma diagnosis.
Description: Technical Summary
The objectives of this study are to develop, validate and compare three clinical prediction rules to advance the diagnosis of myeloma based on risk factors, symptoms and laboratory investigations. Patients over the age of 40 with no previous diagnosis of myeloma and two full blood counts within a year will be identified, with the last test being the index date. Patients will be followed for two years after the index date to establish who did or did not develop myeloma. Data will be randomly split into derivation and validation datasets based on practice location. We will use Cox proportional hazards modelling to derive three different prediction rules of increasing complexity. Subsequently all models will be applied in the validation dataset, and discrimination and calibration will be examined. Performance measures will include ROC curves, R2 statistic, D-statistic and calibration plots. Clinical utility of the algorithms will be examined by the use of decision curve analysis. Multiple imputation methods will be employed in order to deal with missing data.
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Determining the annual proportion of women who could receive an opportunistic assessment of familial breast cancer in primary care to inform an economic model — Matthew Jones ...
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Determining the annual proportion of women who could receive an opportunistic assessment of familial breast cancer in primary care to inform an economic model
Datasets:GP data, HES Admitted Patient Care; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-27
Organisations:
Matthew Jones - Chief Investigator - University of Nottingham
Matthew Jones - Corresponding Applicant - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
Paula Dhiman - Collaborator - University of Nottingham
Stephen Weng - Collaborator - University of NottinghamOutcomes:
Number of women aged 30-60 with no prior history of breast cancer or familial breast cancer between 1st January to 31st December for each year from 2004 to 2016
- Number of relevant appointments (Appendix A) where familial Breast Cancer risk can be assessed between 1st January to 31st December for each year from 2004 to 2016
- Annual proportion of women who have an appointment where familial breast cancer risk could be assessed between 1st January to 31st December for each year from 2004 to 2016Description: Technical Summary
The aim of this study is to determine the annual proportion of women registered in General Practice who have a relevant consultation where the Familial risk of Breast Cancer can be assessed. These appointments include consultations regarding Breast Cancer, Breast pain, first registration at practice, first oral contraceptive appointment, and hormone replacement therapy appointment.
We propose to conduct an observational annual cross-sectional study of women registered at general practice aged 30-60 years with no prior history of Breast Cancer. A descriptive analysis will be conducted to estimate the annual proportion of women with relevant appointments, with stratification by age, ethnicity, and socioeconomic status. This annual proportion will be calculated for each year from 2004 to 2016. The outputs of this study will be used to inform an economic evaluation of current best practice.
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Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Heart Failure Study Component — CRISTINA REBORDOSA GARCIA ...
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Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Heart Failure Study Component
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-27
Organisations:
CRISTINA REBORDOSA GARCIA - Chief Investigator - RTI Health Solutions
Ana Frances Gonzalez - Collaborator - Astra Zeneca Inc - USA
Christine Bui - Collaborator - RTI Health Solutions
Elena Rivero-Ferrer - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Esther Garcia-Gil - Collaborator - Astra Zeneca Inc - USA
Jaume Aguado - Collaborator - RTI Health Solutions
Joan Forns Guzman - Collaborator - RTI Health Solutions
Miguel Cainzos-Achirica - Collaborator - RTI Health Solutions
Nuria Saigi - Collaborator - RTI Health Solutions
Susana Perez-Gutthann - Collaborator - RTI Health SolutionsOutcomes:
First-ever hospitalisation for Heart Failure.
Description: Technical Summary
This nested case-control study aims to evaluate the risk of hospitalisation for heart failure in patients initiating aclidinium bromide and other study medications as compared to LABA and in patients initiating aclidinium bromide as compared to patients initiating other COPD medications. The case-control is nested in a cohort of patients aged 40 years or more with COPD initiating aclidinium bromide or other COPD medications in the CPRD in the UK between 2012 and 2017. All confirmed cases of hospitalisation for heart failure will be included in the nested case-control study. Density sampling will be used to select four controls for each case. Exposure to study medications will be ascertained by recorded prescriptions in the CPRD. Heart failure and heart failure date, and diagnosis for comorbidities of interest, will be defined based on information from the inpatient Hospital Episode Statistic (HES) dataset, the GP OnLine Dataset (GOLD). Statistical analysis will include: 1) descriptive statistics of the cohort, 2) descriptive statistics of cases and controls, and 3) conditional multiple logistic regression to estimate crude and adjusted risk ratios for hospitalisation for heart failure overall and stratified by subgroups of interest.
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Risk factors for self-harm in people with epilepsy — Darren Ashcroft ...
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Risk factors for self-harm in people with epilepsy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Hayley Gorton - Corresponding Applicant - Not from an Organisation
Mark Lunt - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Roger Webb - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
Objectives: i) Estimate the risk of self-harm in people with epilepsy vs. a comparison cohort; ii) identify risk factors for self-harm amongst people with epilepsy and iii) estimate the risk of self-harm associated with individual AEDs compared to valproate.
Methods: The risk of self-harm will be estimated in an incident epilepsy cohort vs. a comparison cohort with no history of epilepsy. From the incident epilepsy cohort, people who have a first self-harm event will be identified (cases) and a nested case-control study will be constructed. The risk of self-harm will be estimated in relation to the following exposures: mental illness, psychotropic medication, frequency of consultations, hospitalisation and AED utilisation. In a separate study, new users of AEDs will be identified from the incident epilepsy cohort and risk of self-harm associated with individual AED will be estimated compared to valproate.
Analysis: The matched cohort will be analysed by a stratified Cox proportional hazards model. Conditional logistic regression will be used to estimate the relative risk of self-harm for each exposure in the nested case-control study. Inverse-Probability of Treatment Weighting propensity scores will be used in a weighted Cox proportional hazards model to estimate hazard ratios for self-harm associated with each AED.
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Correlation of clinical outcomes with patient outcomes and resource use in patients with moderate and severe asthma. — Christopher Morgan ...
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Correlation of clinical outcomes with patient outcomes and resource use in patients with moderate and severe asthma.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
We aim to study clinical and activity outcomes of a population with moderate to severe asthma. The primary objectives are to determine the baseline distribution of blood eosinophil levels and lung function (FEV1) in patients diagnosed with moderate-to-severe asthma; to determine how these impact asthma outcomes and health service utilization and to determine the impact of changing levels of eosinophils and FEV1. Data will be selected from the Clinical Practice Research Datalink including linked Hospital Episode Statistics inpatient and outpatient data. Subjects will be selected from between 2010-2012 by clinical code (Read/ICD-10); disease severity will be based upon first asthma prescription received during the study period. Identified patients will be matched to two sets of controls by age, gender and primary care practice. The first set will have mild asthma defined by first prescription and the second will have no history of asthma. Baseline characteristics of all study cohorts will be presented. Rates of health service utilisation will be compared using Poisson regression models and time to binary co-morbidity outcomes will be compared using Cox proportional hazard models.
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Clinical impact and Health Care Resource Utilization associated with early Chronic Obstructive Pulmonary Disease diagnosis in the United Kingdomâs Clinical Practice Research Datalink — Emil Loefroth ...
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Clinical impact and Health Care Resource Utilization associated with early Chronic Obstructive Pulmonary Disease diagnosis in the United Kingdomâs Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-14
Organisations:
Emil Loefroth - Chief Investigator - NOVARTIS
Valentino Conti - Corresponding Applicant - Not from an Organisation
Andreas Clemens - Collaborator - NOVARTIS
Florian Gutzwiller - Collaborator - University of Basel
Hui Cao - Collaborator - NOVARTIS
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Paul McDwyer - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Robert Fogel - Collaborator - NOVARTISOutcomes:
Primary: Hazard Ratio of time to first COPD exacerbation between early and late diagnosed patients
⢠Secondary: Annual Rate of COPD exacerbation
⢠Secondary: FEV1, FEV1 % predicted, FEV1/FVC, mMRC, and GOLD combined COPD assessment category at baseline
⢠Secondary: Time to triple therapy since first COPD diagnosis
⢠Secondary: Proportion of patients receiving GOLD appropriate therapy after 2-year follow-up
⢠Secondary: Annual rate of COPD related clinical visits, Accident & Emergency visits and hospitalizations
⢠Secondary: COPD related medication use after COPD diagnosis
⢠Secondary: Demographic, comorbidities, and non-COPD related medications at baselineDescription: Technical Summary
The primary objective is to assess the time to and risk of first exacerbation, of early detection of COPD compared to late detection of COPD, among newly diagnosed patients.
The secondary objectives are:
1. Endpoints related to the clinical impact of early COPD: annual rate of exacerbation after 1, 2, and 3 years from the index date, Forced expiratory volume in 1 second (FEV1), FEV1% predicted, FEV1/FVC (forced vital capacity), Modified British Medical Research Council Dyspnea Scale (mMRC), and GOLD combined COPD assessment category at baseline, and risk of reaching triple therapy, i.e. Inhaled Corticosteroids (ICS) plus Long-Acting Beta Agonists (LABA) plus Long-Acting Anticholinergics (LAMA), proportion of patients receiving GOLD appropriate therapy after 2-year follow-up.
2. Endpoints related to the economic impact of early COPD: Annual rate of COPD related clinical visits, Accident & Emergency (A&E) visits and hospitalizations, COPD related medication use in the first, second, and third year after index date, demographic, comorbidities, and non-COPD related medications at baseline.
Multivariable regression models will be implemented according to the nature of the endpoints. Confounding will be addressed via multivariable modelling, using change-in-estimate approach, and propensity score.
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Safety and Effectiveness of Direct Oral Anticoagulants and Warfarin for Stroke Prevention in Non-Valvular Atrial Fibrillation; A Multi-Database Cohort Study with Meta-Analysis — Samy Suissa ...
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Safety and Effectiveness of Direct Oral Anticoagulants and Warfarin for Stroke Prevention in Non-Valvular Atrial Fibrillation; A Multi-Database Cohort Study with Meta-Analysis
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-01
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Madeleine Durand - Collaborator - Centre Hospitalier de l'Universite de Montreal
Mireille Schnitzer - Collaborator - University Of Montreal
Pierre Ernst - Collaborator - McGill University
Rui Nie - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Ischemic stroke; Systemic embolization; Major bleeding; Haemorrhagic stroke; All-cause mortality; Myocardial infarction.
Description: Technical Summary
The objective of this study is to assess the safety and effectiveness of different DOACs in patients newly diagnosed with non-valvular atrial fibrillation and treated by anticoagulation. Three matched cohorts, matching on baseline propensity scores, will be built to compare 1) use of Dabigatran vs. Rivaroxaban, 2) use of Dabigatran vs. Apixaban and 3) use of Rivaroxaban vs Apixaban. The investigators will carry out separate population based cohort studies using administrative health databases in Canada, the United States (US), and the United Kingdom (UK). Only new users of anticoagulants (previously unexposed to any oral anticoagulant in the 365 days before) will be included. Cohort entry date will be defined as date of first dispensation/prescription for the oral anticoagulant. Patients will be considered exposed to the drug they received at cohort entry date for their entire follow-up time. The primary outcome will be the relative incidence of a composite of ischemic stroke or systemic embolization. Outcomes will be modelled using Cox Proportional Hazard survival models to estimate the hazard ratios and their corresponding 95% confidence intervals. Similar analyses will be performed separately in different databases according to a common analytical protocol and then pooled using meta-analysis.
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Fluoroquinolone use and the risk of tendon rupture: a cohort and nested case-control study in the UK Clinical Practice Research Datalink — Susan Jick ...
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Fluoroquinolone use and the risk of tendon rupture: a cohort and nested case-control study in the UK Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-19
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Tendon Rupture; Autoimmune disorders (covariate); Diabetes (covariate); Corticosteroid use (covariate); Osteoarthritis/gout (covariate); Hospitalization (covariate).
Description: Technical Summary
Exposure to fluoroquinolones has been associated with an increased risk of Achilles tendon rupture. However, neither the absolute rate of Achilles tendon rupture nor the risk of tendon rupture at other sites is clear. We will conduct a cohort and a nested case control study of fluoroquinolone exposure and tendon rupture to estimate the absolute rate and relative risk of Achilles, bicep and other tendon ruptures among fluoroquinolone users compared with unexposed patients. In the cohort, we will estimate the absolute rate of tendon rupture at each site among patients with current and recent exposure to fluoroquinolones as well among unexposed patients. We will estimate incidence rate ratios and 95% confidence intervals (CIs) of tendon rupture at each site among patients with current and recent exposure to fluoroquinolones, compared with unexposed patients. In the nested case control, we will match each tendon rupture case to up to 4 controls based on age, sex, general practice and calendar time and will estimate the odds ratio and 95% CI of tendon rupture at each site among fluoroquinolone exposed patients, compared with unexposed patients. These data will provide clinicians additional data to weigh the benefits and harms of fluoroquinolone use for their patients.
Source - and 19 more projects — click to show
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Down Syndrome; co-morbidities, life expectancy and causes of mortality — Andrew Hayward ...
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Down Syndrome; co-morbidities, life expectancy and causes of mortality
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Andrew Hayward - Chief Investigator - University College London ( UCL )
Caoimhe McKenna - Corresponding Applicant - UCL Hospital
Andre Strydom - Collaborator - King's College London (KCL)
Anne Schilder - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Logan Manikam - Collaborator - University College London ( UCL )
Marta Buszewicz - Collaborator - UCL Hospital
Monica Lakhanpaul - Collaborator - Whittington NHS TrustOutcomes:
Congenital cardiac disorders - Psychiatric conditions - Disorders affecting the skin and joints - Disorders of the ear, nose and throat - Gastro-intestinal disorders - Dental conditions - Respiratory conditions - Genitourinary disorders - Visual impairment - Autoimmune disorders - Oncological disorders - Endocrine disorders
Description: Technical Summary
The proposed retrospective cohort study aims to use linked datasets, Hospital Episode Statistics (HES), Clinical Practice Research Datalink (CPRD) and the Cancer Registry, to determine the prevalence of co-morbidities among individuals with Down Syndrome (DS). The study also aims to calculate the average age of death and the causes of mortality.
We will focus on chronic co-morbidities which are considered to be more common among individuals with DS compared to the general population; Cardiac disease, disorders of the ear, nose and throat, visual and hearing impairment, neurological and psychiatric conditions, gastrointestinal disorders, autoimmune and haematological conditions, endocrine disorders, disorders affecting the skin and joints, dental conditions and oncological disorders. We will compare the prevalence of co-morbidities among those with DS and a matched control group, as well as comparing prevalence among DS subgroups (i.e. gender, age and ethnicity).
We are not aware of any existing literature outlining the causes of death or prevalence of multiple co-morbidities in a large cohort of individuals with DS compared with matched controls, using an extensive linked dataset. The use of linked data will provide a more comprehensive overview of participant health. This research will provide a useful reference for health professionals, policy-makers and academics.
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Glucagon-like peptide-1 analogues and the risk of diabetic retinopathy — Samy Suissa ...
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Glucagon-like peptide-1 analogues and the risk of diabetic retinopathy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Antonios Douros - Collaborator - McGill University
Jacob (Jay) Udell - Collaborator - University of Toronto
Kristian Filion - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Mayhar Etminan - Collaborator - University Of British Columbia
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Diabetic retinopathy.
Description: Technical Summary
Glucagon-like peptide-1 (GLP-1) analogues are effective second-to-third line antidiabetic drugs. Recently, they showed a higher incidence of retinopathy compared to placebo in clinical trials. Therefore, the primary objective of this study is to determine whether the use of GLP-1 analogues is associated with an increased risk of diabetic retinopathy in patients with type 2 diabetes. For this purpose, a cohort of type 2 diabetes patients with no history of retinopathy and newly treated with a noninsulin antidiabetic drug between January 1, 2007 and September 30, 2015 will be assembled. Time-dependent Cox proportional hazard models will be used to estimate adjusted hazard ratios and 95% confidence intervals for diabetic retinopathy (defined via outpatient or inpatient diagnoses) associated with current use of GLP-1 analogues, compared to current use of 2 or more oral antidiabetic drugs. Secondary analyses will assess whether there is a duration- or drug-specific-response relationship between current use of GLP-1 analogues and risk of diabetic retinopathy, and whether duration of treated type 2 diabetes modifies the association.
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Effect of prescribing long-term antibiotics for recurrent urinary tract infection (UTI) in older adults — Harry Ahmed ...
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Effect of prescribing long-term antibiotics for recurrent urinary tract infection (UTI) in older adults
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-08
Organisations:
Harry Ahmed - Chief Investigator - Cardiff University
Harry Ahmed - Corresponding Applicant - Cardiff University
Christopher Butler - Collaborator - University of Oxford
Daniel Farewell - Collaborator - Cardiff University
Nicholas Francis - Collaborator - Cardiff University
Shantini Paranjothy - Collaborator - University of AberdeenOutcomes: none known
Description: Technical Summary
Urinary tract infection (UTI) is a leading cause of morbidity, health service use and antibiotic prescribing in older people. Recurrent UTI is defined as three or more UTIs in a year. Prevention of recurrent UTI using daily low-dose antibiotics is the indication for almost half of antibiotic prescriptions in the frail elderly. Trials in post-menopausal women showed a reduction in UTI recurrence rates in those prescribed long-term antibiotics but were uninformative about effects in older men, short (<6 months) or longer term (>15 months) outcomes, and were insufficiently powered to study rare outcomes such as hospitalisation. We will use GP and hospital data from the Clinical Practice Research Datalink to investigate gender-specific short and long-term effects of long-term antibiotic prescribing in a cohort of older adults with recurrent UTI. We will undertake recurrent event analyses to estimate incident rates of UTI recurrence, UTI hospitalisation, all-cause antibiotic prescribing and all-cause hospitalisation. We will apply a random effects shared frailty model to account for unmeasured heterogeneity between participants, and adjust for a range of confounding variables. The over-arching aim of these analyses is to inform a more evidence-based approach to antibiotic prophylaxis for recurrent UTI in the elderly.
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Trajectory and sequence analysis of readmissions in heart failure patients — Alex Bottle ...
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Trajectory and sequence analysis of readmissions in heart failure patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-14
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Ahsan Rao - Corresponding Applicant - Imperial College London
Ahsan Rao - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Paul Aylin - Collaborator - Imperial College LondonOutcomes:
Annual emergency readmission rate
⢠common causes of emergency readmissions
⢠overall mortality rateDescription: Technical Summary
Relatively new statistical models, trajectory and sequence analysis, have been used in clinical research to categorise patient population into groups and evaluate the trends of their outcomes in the longitudinal data series. In contrast to previous studies, these techniques classify patients based on the repetitive measure of the chosen outcome with long follow-up period. By conducting a retrospective cohort study, our objective is to apply these techniques to the linked administrative data. The main outcome measure will be annual readmission rate and annual GP out-of-hours visits. The data will be converted to longitudinal data series during the process of modelling. The patient population will be divided into subgroups and the high-risk users will be identified. Their pattern of readmission rate and GP visits will be displayed. The significant predictors, community and secondary care based, of the high-risk users will be identified. Once high-risk users will be recognised, sequence analysis will be conducted to assess the common causes and their distinct sequences of emergency admissions. The linked data will be used to identify most patients with the first-time diagnosis of HF, either in the community or in the hospital and to retrieve information on various community based risk factors.
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Itraconazole and risk of cancer: a propensity score matching study — Shahinaz Gadalla ...
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Itraconazole and risk of cancer: a propensity score matching study
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-27
Organisations:
Shahinaz Gadalla - Chief Investigator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Corresponding Applicant - National Cancer Institute ( NCI )
Fatma Shebl - Collaborator - Yale School of Public Health
Hormuzd A Katki - Collaborator - Cincinnati Children's Hospital Medical Center
Lesley Anderson - Collaborator - Queen's University Belfast
Liam Murray - Collaborator - Queen's University Belfast
Mark H Greene - Collaborator - National Cancer Institute ( NCI )
Youjin Wang - Collaborator - National Cancer Institute ( NCI )Outcomes: none known
Description: Technical Summary
Itraconazole is a triazole antifungal drug used to treat systemic as well as common skin fungal infections. Pre-clinical growing evidence reveals that itraconazole may have anticancer properties via its role as a modifier of sonic Hedgehog signalling. In this propensity-matched cohort study, we will compare the risk of cancer (overall, and by anatomic site) in a cohort of new itraconazole users with a matched control group selected from users of other oral antifungal medication who were not exposed to itraconazole. We will use a propensity-score matching approach to select the control group from individuals treated for fungal infection while adjusting for confounders associated with their prescribing patterns. We will then calculate incidence rate ratio (IRR) and 95% confidence interval (CI) for cancer in the itraconazole and control group. We will also evaluate the survival outcome in patients diagnosed with cancer during follow-up, and those with history of prior cancer comparing the itraconazole and the control group.
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X-linked Hypophosphataemia: UK prevalence and health care usage — Kassim Javaid ...
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X-linked Hypophosphataemia: UK prevalence and health care usage
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-07
Organisations:
Kassim Javaid - Chief Investigator - University of Oxford
Kassim Javaid - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Rafael Pinedo-Villanueva - Collaborator - University of OxfordOutcomes:
To validate the Read codes for XLH within routine primary care records; To calculate the prevalence with XLH in the UK; To determine the health-related costs of patient with XLH; To describe the patterns of primary care usage of patients with XLH; To describe the patterns of secondary care usage of patients with XLH
Description: Technical Summary
X-Linked Hypophosphataemia (XLH) is a rare disease effecting the bones and joints. At present neither the prevalence, natural history nor economic burden of XLH is not known. This proposal will validate an algorithm to ascertain diagnoses of XLH using routine health record coding and then describe the natural history and health care usage of these patients. To confirm the codes within CPRD are accurately recording diagnoses of XLH, we will use the CPRD verification study where the GPs are sent a brief anonymous questionnaire. We will use the results from the questionnaire to validate a diagnostic algorithm using clinical, laboratory, medication or surgical feature(s) and, where available, HES ICD10 data and determine the estimated prevalence of XLH. We will describe the other diagnoses/ procedures to understand the natural history, health care usage and costs for people with XLH and their determinants using CPRD and where available linkage to HES. We will compare these findings with up to 4 controls of the same age, gender and GP practice. This research will provide the prevalence of XLH and the current health care usage/ costs.
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A cohort study of cancers and all cause and cause specific mortality in eczema — Sinead Langan ...
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A cohort study of cancers and all cause and cause specific mortality in eczema
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Katrina Abuabara - Collaborator - University Of California, San Francisco
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Morten Schmidt - Collaborator - Aarhus University Hospital
Richard Silverwood - Collaborator - University College London ( UCL )
Sigrun Alba Johannesdottir Schmidt - Collaborator - Aarhus University HospitalOutcomes:
Cancer Study Primary outcomes:
- First occurrence of any cancer in CPRD or linked HESMortality Study Primary outcomes:
- All-cause mortality
- Cause-specific mortality
- First occurrence of specific cancers including skin, lung, breast, prostate and haematological cancersDescription: Technical Summary
The objectives of this study are to use data from Clinical Practice Research Database (CPRD), Hospital Episodes Statistics and the Office for National Statistics (ONS) to examine associations between eczema and cancers and death.
Identifying people with eczema :
Populations with eczema will be identified in CPRD using a recently developed validated algorithm (in press) comprising Read codes and therapies and /or using ICD-10 codes in linked HES data.Eczema and cancer and death:
There is conflicting data regarding the associations between eczema and specific cancers. A recent publication also suggests that mortality may be increased in individuals hospitalised with eczema, however, there is limited data on all cause and cause-specific mortality in the general population. We will examine if adults with eczema have higher rates of specific cancers and death (all-cause and cause-specific mortality). We will use time-updated Cox regression to compute hazard ratios with 99% confidence intervals to assess the associations between eczema and each outcome. We will examine the robustness of our results using several sensitivity analyses.
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Use of aspirin and statins in patients with retinal vascular occlusion and its association with cardiovascular diseases — Li Wei ...
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Use of aspirin and statins in patients with retinal vascular occlusion and its association with cardiovascular diseases
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-08
Organisations:
Li Wei - Chief Investigator - University of Dundee
Li Wei - Corresponding Applicant - University College London ( UCL )
Qian Wang - Collaborator - Beijing Tongren Hospital
Thomas MacDonald - Collaborator - University of DundeeOutcomes:
Retinal vein occlusion; Stroke; Myocardial infarction.
Description: Technical Summary
Objectives: To investigate the prevalence of retinal vascular occlusions in the UK and the association between the use of cardiovascular drugs (i.e. aspirin and lipid lowering drugs) and cardiovascular disease outcomes in patients with retinal vascular occlusions. Methods: A population-based cohort study will be conducted between 1995 and 2016. We will 1) calculate prevalence of retinal vascular occlusions in the CPRD population; and 2) calculate cumulative incidence of myocardial infarction (MI) and stroke in patients with retinal vascular occlusions. We will compare the risk of incident stroke and MI between the drug-exposure groups (aspirin-alone, lipid lowering therapy-alone and combined group) and the non-exposure group and estimate whether aspirin and lipid-lowering therapy have the cardiovascular protect effects in patients with retinal vascular occlusions. Data analysis: The risk of stroke and MI between the groups will be compared using a Cox regression model. Kaplan-Meier plot will be used to calculate the cumulative incidence rates of stroke and MI between the groups and the log-rank test will be used to analyse the differences between the survival curves.
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Post-authorization Safety Study: Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder in the CPRD — Alejandro Arana Navarro ...
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Post-authorization Safety Study: Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder in the CPRD
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-29
Organisations:
Alejandro Arana Navarro - Chief Investigator - RTI Health Solutions
Alejandro Arana Navarro - Corresponding Applicant - RTI Health Solutions
Andrea Margulis - Collaborator - RTI Health Solutions
Billy Franks - Collaborator - Astellas Pharmaceuticals
Christine Bui - Collaborator - RTI Health Solutions
David Martinez - Collaborator - RTI Health Solutions
Diana Eid - Collaborator - RTI Health Solutions
Jamie Robinson - Collaborator - Astellas Pharmaceuticals
Kenneth Rothman - Collaborator - RTI Health Solutions
Kwame Appenteng - Collaborator - Astellas Pharmaceuticals
Lisa McQuay - Collaborator - RTI Health Solutions
Maria Reynolds - Collaborator - RTI Health Solutions
Martin Backhouse - Collaborator - RTI Health Solutions
Miguel Cainzos-Achirica - Collaborator - RTI Health Solutions
Milbhor D'Silva - Collaborator - Astellas Pharmaceuticals
Ryan Ziemiecki - Collaborator - RTI Health Solutions
Stefan de Vogel - Collaborator - Astellas Pharmaceuticals
Susana Perez-Gutthann - Collaborator - RTI Health Solutions
Willem Jan Atsma - Collaborator - Astellas PharmaceuticalsOutcomes:
Cardiovascular outcomes: acute myocardial infarction, stroke, CV mortality, all-cause mortality and a composite measure of major adverse cardiovascular events (MACE), defined as the first of AMI, stroke, or CV mortality.
Description: Technical Summary
This will be a cohort study comparing the incidence of cardiovascular (CV) outcomes among new users of mirabegron and new users of any comparator antimuscarinic medication, as a group, used in the treatment of overactive bladder (OAB). Incidence rates for the following CV outcomes will be calculated: Acute myocardial infarction (AMI); Stroke; CV mortality (comprised of coronary heart disease [CHD] death and cerebrovascular disease death); All-cause mortality; and a composite measure of major adverse cardiovascular events (MACE), defined as the first of AMI, stroke, or CV mortality. The incidence of these CV outcomes will be estimated within each of two exposure cohorts and additional analyses of comparisons of mirabegron to individual antimuscarinic medications will be conducted. We will compare CV incidence after exposure to mirabegron and to antimuscarinics. Potential confounders will be addressed and the outcomes will be modelled, accounting for differences in follow-up time between the cohorts. Adjustment for potential confounders will be performed by matching on propensity score (PS) to balance cohorts with respect to factors present at or before the time of cohort entry. Results will be expressed as estimated adjusted hazard ratios (HRs) of the study outcomes along with confidence intervals (CIs).
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The Effects of Adherence and Treatment Intensity on Cardiovascular Outcomes in Patients with Atherosclerosis or Other Cardiovascular Risk Factors Treated with Statins and/or Ezetimibe: A Cohort Study in the United Kingdom — Mark Danese ...
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The Effects of Adherence and Treatment Intensity on Cardiovascular Outcomes in Patients with Atherosclerosis or Other Cardiovascular Risk Factors Treated with Statins and/or Ezetimibe: A Cohort Study in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-29
Organisations:
Mark Danese - Chief Investigator - Outcomes Insights ( Outins )
Mark Danese - Corresponding Applicant - Outcomes Insights ( Outins )
David Catterick - Collaborator - Amgen Ltd
Francisco Sorio-Vilela - Collaborator - Amgen Ltd
Kamlesh Khunti - Collaborator - University of Leicester
Kausik Ray - Collaborator - Imperial College London
Lucie Kutikova - Collaborator - Amgen Ltd
Michelle Gleeson - Collaborator - Outcomes Insights ( Outins )
Sreenivasa Rao Kondapally Seshasai - Collaborator - St George's University Hospitals NHS Foundation TrustOutcomes:
The primary outcome measure will be a composite endpoint of CV death or hospitalization for one the following CV events:
myocardial infarction (MI)
unstable angina (UA)
ischemic stroke (IS)
heart failure (HF)
surgical or percutaneous revascularization (revascularization)Description: Technical Summary
Patients may not benefit fully from the use of lipid-lowering agents for at least 2 reasons. First, they may not receive a sufficiently intensive regimen which is directly related to the degree of cholesterol reduction. Second, they may not adhere to their medication properly, either by not taking medication consistently, or by discontinuing their medication altogether. Studies have shown that adherence with lipid-lowering therapy is associated with improved cardiovascular outcomes. Therefore, this retrospective cohort study of new users of statins and/or ezetimibe will address the contributions of both factors by characterizing adherence and treatment intensity for each patient over time. Adherence will be assessed using prescription records to estimate the proportion of days covered by lipid-lowering therapy. These characteristics will then be used to understand the effects of adherence and intensity on CV outcomes in patients initiating statin and/or ezetimibe therapy who have cardiovascular disease, familial hypercholesterolemia, stage 4 chronic kidney disease, or type 2 diabetes. The primary outcome measure is a composite endpoint of CV death or hospitalization for one the following CV events: myocardial infarction, unstable angina, ischemic stroke, heart failure, or surgical or percutaneous revascularization. Analyses will be conducted using Cox proportional hazards time to event analyses.
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An examination of the clinical management of children and young people aged 12-24 diagnosed with depression for the first time — Jane Sarginson ...
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An examination of the clinical management of children and young people aged 12-24 diagnosed with depression for the first time
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-21
Organisations:
Jane Sarginson - Chief Investigator - University of Manchester
Darren Ashcroft - Corresponding Applicant - University of Manchester
Aneez Esmail - Collaborator - University of Manchester
Jill Stocks - Collaborator - University of Manchester
Roger Webb - Collaborator - University of Manchester
Shruti Garg - Collaborator - University of ManchesterOutcomes:
Rates of depression diagnosis; Frequency of contact with primary care; Patterns of referral to speciality services; Time to antidepressant treatment initiation; Antidepressant class prescribed; Duration of antidepressant prescribing; Differences in demographics by age band, including gender and IMD quintile distributions; Frequency and type of contact with secondary care services
Description: Technical Summary
Adolescence and young adulthood is an increased risk period for the development of depression. This study will investigate the relationship between the characteristic of patients with a first-ever recording of a depression diagnosis in CPRD including their age at date of diagnosis and their clinical management. It will examine changes in the rates and characteristics of 12-24 year olds receiving a depression diagnosis between 2010-2016. It will then examine in more detail the clinical management of 12-24 year olds with a first-ever depression diagnosis recorded between 2012-2014 in CPRD by age band (12-14, 15-17, 18-20, 21-24). Clinical management will be described by the frequency of their contact with primary care, referral to specialist services and antidepressant prescribing within a general practice setting in the year either side of their initial diagnosis. The frequency and speciality of hospital based service use will be examined in the sub-group of patients with linked HES data. The prevalence of other comorbid mental health conditions recorded during the study window and their impact on clinical management will be reported and discussed.
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To assess whether landmarking and/or latent classes are better than traditional methods for assessing the relationship between changes in lung function (FEV1) over time and mortality in a primary care COPD cohort with multiple co-morbidities — Steven Kiddle ...
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To assess whether landmarking and/or latent classes are better than traditional methods for assessing the relationship between changes in lung function (FEV1) over time and mortality in a primary care COPD cohort with multiple co-morbidities
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-05
Organisations:
Steven Kiddle - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Steven Kiddle - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Hannah Whittaker - Collaborator - Imperial College London
Jennifer Quint - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UKOutcomes:
Death
Description: Technical Summary
People with COPD have a faster decline in their lung function than people without COPD. However, little is known about how quickly lung function declines in a primary care cohort in an average COPD patient. We are beginning to address this in an already approved clinical epidemiology project (16_186R). In this methodological study we wish to take this work further to study the impact of co-morbidities, testing the ability of landmarking analysis (i.e. dynamic prediction) to model the relationship between co-morbidities and FEV1 decline and their ability to predict mortality in COPD patients. This will be performed using 10-years worth of FEV1 data. In a secondary analysis we will also study latent class analysis can identify COPD patient subtypes with different prognoses. Preliminary work will establish whether co-morbid patients have different FEV1 decline profiles using mixed effect models, using inverse probability weighting to account for selection bias in those with sufficient longitudinal data. Analyses and interpretation will be performed with informative presence in mind, for example we will focus on prediction of mortality (which is well recorded) rather than on causal analyses which would have been biased by missing data and residual confounding.
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What are the optimal cardiovascular risk assessment and treatment targets among patients diagnosed with specific inflammatory disorders? — Alex Dregan ...
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What are the optimal cardiovascular risk assessment and treatment targets among patients diagnosed with specific inflammatory disorders?
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-27
Organisations:
Alex Dregan - Chief Investigator - King's College London (KCL)
Alex Dregan - Corresponding Applicant - King's College London (KCL)
David D'Cruz - Collaborator - Lupus Research Unit
Mariam Molokhia - Collaborator - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)
Phil Chowienczyk - Collaborator - King's College London (KCL)
Yanzhong Wang - Collaborator - King's College London (KCL)Outcomes:
Stroke
- Type 2 diabetes
- Myalgia
- Myocardial infarction
- Peripheral artery disease
- Myopathy
- Angina
- Elevation in kidney tests
- Depression
- Mortality
- Elevation in liver tests
- Anxiety
- Rhabdomyolysis
- FracturesDescription: Technical Summary
The exact contributions of vascular risk factors and inflammation to the increased cardiovascular risk across diverse inflammatory disorders is unclear. Also, current CVD risk score calculators underestimate CVD risk in inflammatory disorders, and limited empirical evidence is available on how best to manage CVD risk across diverse inflammatory disorders and population subgroups. The proposed study aims to address these gaps using primary care electronic health records linked with hospital records. The study will implement time to event analyses to evaluate the independent and combined influence of hypertension and total cholesterol, as well as inflammation on the risk of myocardial infarction, stroke, angina, diabetes, and peripheral vascular disease. The study will also evaluate the prognostic value of adding arterial stiffness data to the QRISK2 risk score to predict future CVD risk. Further, the study will investigate the long-term safety of setting more stringent blood pressure and total cholesterol targets within specific chronic inflammatory disorders. The potential for these associations to vary by populations subgroups defined by gender, ethnicity, and deprivation will be explored. The inflammatory disorders considered are those known to confer increased risk of CVD events, such as rheumatoid arthritis, psoriasis, lupus, inflammatory bowel diseases, ankylosing spondylitis, and vasculitis.
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Can the GOLD 2017 strategic report recommendations be implemented in primary care? A descriptive study of patient classifications and treatment costs â GOLD DUST — Chris D Poole ...
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Can the GOLD 2017 strategic report recommendations be implemented in primary care? A descriptive study of patient classifications and treatment costs â GOLD DUST
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-08
Organisations:
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Alicia Gayle - Corresponding Applicant - Imperial College London
Gavin Chiu - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
James Clark-Wright - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Kevin Morris - Collaborator - Boehringer-Ingelheim - UKOutcomes:
COPD patients by GOLD 2017 category using primary care EHR data and describe their demographic and clinical characteristics
⢠comparison of the GOLD 2017 classification distribution with that arising from the 2016 and prior editions
⢠estimatation of the treatment costs of implementing the GOLD 2017 recommendations and provide comparison with current inhaled treatment costsDescription: Technical Summary
This study is a non-interventional cohort study using existing data (CPRD), to gain detailed insights on the characteristics of COPD patientsâ severity according to the latest Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 document. This report recommends that patientsâ disease severity be assessed solely on current symptoms and previous exacerbations, independent of lung function. The potential effect that this may have on prognosis and subsequent treatment is yet to be studied. The main objective of this study is to characterise patients according to the GOLD 2017 report and compare this with previous characterisations. Descriptive statistics, chi-squared, ANOVA and Wilcoxon rank sum tests, will be used to describe the estimated drug costs associated with GOLD treatment recommendations following categorisation of patients using the 2017 framework. The results from this study will be used to support the scientific understanding of how this new assessment of disease severity and updated therapy recommendation may influence primary care COPD management strategies. Comorbidities and demographic information will be described for the groups of patients within each severity group.
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Intra- and Post-operative Bleeding Events in Selected Operations in the English Inpatient Hospital Setting: Incidence, Risk Factors, and Impact on Length of Stay — Stephen Johnston ...
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Intra- and Post-operative Bleeding Events in Selected Operations in the English Inpatient Hospital Setting: Incidence, Risk Factors, and Impact on Length of Stay
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-21
Organisations:
Stephen Johnston - Chief Investigator - Johnson & Johnson UK
Stephen Johnston - Corresponding Applicant - Johnson & Johnson UK
Erica (Eric) Ammann - Collaborator - Johnson & Johnson ( JnJ - USA )
Katherine Etter - Collaborator - Johnson & Johnson UK
Nadine Jamous - Collaborator - Johnson & Johnson UK
Nawwar Al-Attar - Collaborator - NHS Scotland
Sameer Mistry - Collaborator - Johnson & Johnson UKOutcomes:
Diagnosis of haemorrhage and haematoma complicating a procedure; Hospital length of stay (LOS); Bleeding requiring reoperation; Number of critical care days; Bleeding requiring blood transfusion
Description: Technical Summary
The objective of this retrospective, observational cohort study is to evaluate the incidence of, risk factors for, and hospital LOS associated with intra- and post-operative bleeding events in selected operations in the English inpatient hospital setting. Patients will be selected for study if they underwent an operation of interest (index operation, grouped as: coronary artery bypass graft/valve replacement; aortic operation, heart transplantation; cholecystectomy; hernia repair; hysterectomy; knee/hip operations; low anterior resection; lung operations; mastectomy; prostate operations) between Jan-1-2010 and Feb-29-2016. For each index operation group separately, the incidence of bleeding events (diagnosis of haemorrhage and haematoma complicating a procedure, bleeding requiring transfusion, and/or bleeding requiring reoperation) will be ascertained during the hospital spell in which the index operation was performed (index hospital spell) and within 14 days post discharge; event occurring during the index hospital spell will be further classified as being intra-operative vs. post-operative. Incidence will be expressed as the proportion of patients experiencing each type of bleeding event during the index hospital spell (separated by intra- and post-operative), within 14 days post discharge, and/or both. Multivariable regression analyses will be performed to: (1) examine whether selected pre-specified patient characteristics (e.g., demographics, comorbidities) are associated with an increased risk of experiencing each type of bleeding event; and, (2) compare hospital LOS and critical care days (separately) between patients who experience bleeding event(s) versus those who do not.
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Aromatase inhibitors and risk of dementia in postmenopausal women with early-stage breast cancer: a retrospective cohort study in UK primary care — Krishnan Bhaskaran ...
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Aromatase inhibitors and risk of dementia in postmenopausal women with early-stage breast cancer: a retrospective cohort study in UK primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-27
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Susan Bromley - Corresponding Applicant - Not from an Organisation
Anthony Matthews - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Susannah Stanway - Collaborator - Royal Marsden HospitalOutcomes:
Cases of dementia will be identified by the presence of a Read code documented in the patient clinical or referral record and/or a prescription for a dementia-specific medication in the patient prescribing record. The date of dementia will be the earliest of the date of the first dementia Read code or the date of the first prescription for dementia-specific medication; the presence of either will be sufficient for case status, i.e. women who have a prescription for a dementia-specific medication but no dementia Read code (and vice versa) will be considered to be cases. Dementia cases will be classed into four types: Alzhemierâs disease, vascular dementia, dementia with Lewy bodiesâ, mixed dementia and unknown. In previous validation studies, diagnoses of dementia recorded in CPRD-GOLD have been found to have a positive predictive value of between 83% and 84%.
Description: Technical Summary
Breast cancer is the most commonly diagnosed cancer in women in the UK. Around 80% of breast cancers in postmenopausal women are oestrogen-receptor-positive and can be treated effectively with adjuvant aromatase inhibitor (AI) therapy to slow growth and prevent recurrence. These hormonal agents inhibit the conversion of androgens to oestrogen, significantly reducing circulating levels of oestrogen available to stimulate growth of breast cancer cells. Substantial evidence from animal studies, and from some clinical studies, suggest oestrogen plays an important role in cognition. Impaired cognitive function is commonly reported in women with breast cancer following treatment, and it is possible that AIs could play a role. Among the few adequately powered studies that have evaluated the relationship between AIs and cognitive function none have evaluated the risk of dementia in women using these medications in a real-word setting. From a cohort of postmenopausal women with breast cancer identified from CPRD primary care data, we aim to compare the risk of incident dementia among women prescribed an AI compared with those prescribed tamoxifen using Cox regression analyses adjusting for potential confounders. Our findings will help inform patient and physicians on the safety profile of AIs.
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Ethnic inequalities in trajectories of cardio-metabolic risk factor control and outcomes of type two diabetes — Rohini Mathur ...
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Ethnic inequalities in trajectories of cardio-metabolic risk factor control and outcomes of type two diabetes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-08
Organisations:
Rohini Mathur - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Archie Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nishi Chaturvedi - Collaborator - University College London ( UCL )
Ruth Farmer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Sophie Eastwood - Collaborator - University College London ( UCL )Outcomes:
Diabetes Mellitus; Myocardial Infarction; Nephropathy (CKD); Coronary Heart Disease; Heart Failure; Neuropathy; Stroke; Retinopathy
Description: Technical Summary
Type 2 diabetes increases the risk of vascular disease, with co-morbid hypertension and hyperlipidaemia increasing risk further. UK studies have found substantial ethnic differences in the risk of vascular outcomes amongst individuals with type 2 diabetes. Whether these inequalities stem from differences in healthcare usage, quality of care, or differences in treatment efficacy remains unknown. Pharmacological control of blood pressure and blood glucose has been shown to profoundly reduce vascular risk. However, to date, no study has adequately examined whether these benefits manifest equally across different ethnic groups. The aim of this study is to identify clinical factors underlying ethnic inequalities in vascular outcomes of type 2 diabetes in order to generate an evidence base for clinical management of diabetes tailored to the UK population. Firstly, using multilevel linear and logistic regression, ethnic differences in the access to health care and the identification of high cardiovascular risk will be quantified. Secondly, using logistic regression, amongst individuals classified as being at high risk, ethnic differences in the prescription of appropriate and timely antidiabetic, antihypertensive, and lipid lowering treatment will be determined. Thirdly, amongst patients prescribed appropriately, ethnic differences in trajectories of risk factor control following treatment initiation and time taken to achieve control to target by ethnic group will be compared using latent class growth curve modelling. Finally, the causal relationship between pharmacological treatment and major vascular outcomes will be compared between ethnic groups using survival analysis incorporating marginal structural models.
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Using electronic health records to facilitate earlier diagnosis of dementia — Spiros Denaxas ...
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Using electronic health records to facilitate earlier diagnosis of dementia
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-06
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Spiros Denaxas - Corresponding Applicant - University College London ( UCL )
Kate Walters - Collaborator - University College London ( UCL )
Martin Rossor - Collaborator - University College London ( UCL )
Maxine Mackintosh - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
Objective:
The primary objective of this study is to explore the use of electronic health records to identify clinically significant markers of early cognitive decline (referred to as prodromal markers) associated with dementia. The methods developed through this research project will potentially enable the earlier diagnosis of people with dementia.
Methods & Data analysis:
Part I: Exploratory, hypothesis-generation to examine occurrence and recording patterns of prodromal markers prior to dementia diagnosis. Prodromal markers with the highest frequency, supplemented by clinical expert knowledge and literature of common prodromal markers will be further investigated. Markers in the following clinical categories will be explored: a) activity complementary to dementia diagnosis, b) healthcare utilisation patterns, d) cognitive symptoms, d) motor symptoms, e) affective symptoms, f) autonomic symptoms, g) prescriptions of dementia-specific medication and h) routinely conducted tests when dementia is being investigated.Part II: Hypothesis-testing, retrospective nested case-control study. We will apply logistic regression to measure the strength of the association between the prodromal markers and diagnosis of dementia across different time periods.
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Understanding the role of serum electrolytes in the presentation of specific fatal and non-fatal cardiovascular disease syndromes: a research proposal using linked CPRD-HES-ONS data — Sandosh Padmanabhan ...
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Understanding the role of serum electrolytes in the presentation of specific fatal and non-fatal cardiovascular disease syndromes: a research proposal using linked CPRD-HES-ONS data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-06-26
Organisations:
Sandosh Padmanabhan - Chief Investigator - University of Glasgow
Sandosh Padmanabhan - Corresponding Applicant - University of Glasgow
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Harry Hemingway - Collaborator - University College London ( UCL )
Linsay McCallum - Collaborator - University of Glasgow
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Qianrui Li - Collaborator - Sichuan University
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Simon G Anderson - Collaborator - University of Manchester
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
We will examine the association between electrolytes and the following CVD outcomes: All-cause mortality (identified through ONS data) Fatal and non-fatal CVD outcomes: Stable angina (identified from CPRD diagnoses, prescription of nitrates or from HES diagnoses) Unstable angina (identified from CPRD/HES diagnoses) Coronary artery disease not further specified (identified from CPRD/HES diagnoses) Acute myocardial Infarction (identified from CPRD/HES diagnoses) Unheralded coronary death (identified from ONS data) Heart failure (identified from CPRD/HES diagnoses) Ventricular arrhythmia (identified from CPRD/HES diagnoses) trial fibrillation (identified from CPRD/HES diagnoses) Sudden cardiac death (identified from ONS data) Transient ischaemic attack (identified from CPRD/HES diagnoses) Ischaemic stroke (identified from CPRD/HES diagnoses) Stroke not further specified (identified from CPRD/HES diagnoses) Subarachnoid haemorrhage (identified from CPRD/HES diagnoses) Intracerebral haemorrhage (identified from CPRD/HES diagnoses) Peripheral atrial disease (identified from CPRD/HES diagnoses) Abdominal aortic aneurism (identified from CPRD/HES diagnoses)
Description: Technical Summary
The electrolytes in serum and urine (sodium (Na+), potassium (K+), bicarbonate, (HCO3), chloride (Cl-) and calcium (Ca2+) as well as the important renal biomarkers (urea, creatinine, phosphate, urate and microalbumin) play an integral role in intermediary metabolism and cellular function. Imbalances in the intra- and extracellular concentrations of each electrolyte are associated with adverse metabolic and physiological consequences. Under normal conditions homeostasis is maintained between intake, intra/extracellular shifts and excretion. In most cases depletion or repletion of electrolytes occur in tandem, requiring consideration of related cation/anion biomarker species (e.g. Na+ and K+). Electrolyte anomalies are commonly described in hospitalized patients and are associated with increased morbidity and mortality. There are few studies however examining electrolyte anomalies in non-acute populations such as the ones encountered in primary care. The objective of this study is to examine separately, for independence, the relationship between the first recorded measurement of each biomarker and the incidence of various diagnosed CVD events and cause-specific mortality. For this longitudinal cohort of men and women aged 18 and older, we will employ risk prediction models, clustered by practice to determine the associations. Models will be validated for their discrimination, calibration and overall fit using a panel of sensitivity analyses.
Source
2017 - 05
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Characterization of Chronic Obstructive Pulmonary Disease (COPD) patients initiating inhaled triple therapy in the United Kingdom — Leah Sansbury ...
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Characterization of Chronic Obstructive Pulmonary Disease (COPD) patients initiating inhaled triple therapy in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-09
Organisations:
Leah Sansbury - Chief Investigator - GlaxoSmithKline - UK
Leah Sansbury - Corresponding Applicant - GlaxoSmithKline - UK
Joe Maskell - Collaborator - Amgen Ltd
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.Outcomes:
Patient demographics
- Respiratory history and disease severity
- Respiratory medications
- Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations)Description: Technical Summary
The purpose of this study is to identify and characterize a cohort of COPD patients who initiate an inhaled triple regimen (LAMA+LABA+ICS by either using three separate therapies or a monotherapy coupled with a fixed combination dual therapy). In a cohort of COPD patients who were actively registered in CPRD practices, we will describe the patients' demographics, disease burden, and heath care resource utilization in the 12 months prior to initiating inhaled triple therapy. In addition, we will describe what maintenance treatment the patient was on prior to stepping-up to inhaled triple therapy, the duration of triple use over 12 months, and the treatment modification that lead to the discontinuation of triple therapy. There will be two distinct study-time periods for data collection. The first will begin in mid-2011 to allow for capture of possible treatment patterns before the approval of the LAMA/LABA therapy and the second will begin mid-2013, to capture treatment patterns after the LAMA/LABA drug was approved, which came to market in early 2013 as part of the triple regimen.
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Post-authorisation safety study to assess the risk of urinary tract malignancies in relation to empagliflozin exposure in patients with type 2 diabetes: a multi-database European study — Fabian Hoti ...
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Post-authorisation safety study to assess the risk of urinary tract malignancies in relation to empagliflozin exposure in patients with type 2 diabetes: a multi-database European study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-23
Organisations:
Fabian Hoti - Chief Investigator - Statfinn Oy
Katja Hakkarainen - Corresponding Applicant - IQVIA - USA (Headquarters)
Alisa Kopilow - Collaborator - IQVIA
Anouk Deruaz Luyet - Collaborator - Boehringer-Ingelheim International GmbH
Eric Beohou - Collaborator - EPID Research Oy
Julia Pietilä - Collaborator - EPID Research Oy
Kimberly Brodovicz - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Muriel Lobier - Collaborator - EPID Research Oy
Rownak Jahan Archie - Collaborator - EPID Research Oy
Soulmaz Fazeli Farsani - Collaborator - Boehringer-Ingelheim International GmbH
Xu Qiao - Collaborator - EPID Research OyOutcomes:
Primary outcomes o All urinary tract cancers o Bladder cancer o Renal cancer ⢠Further outcome o Non-renal, non-bladder urinary tract cancers (referred to as other urinary tract cancers)
Description: Technical Summary
The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating other sodium glucose co-transporter-2 inhibitors and to patients initiating dipeptidyl peptidase-4 inhibitors (2 separate comparison groups). The study is an observational, comparative, cohort safety study based on healthcare databases in the United Kingdom and Sweden. The databases for this study are constructed from linked prescription, hospital, general practitioner, cancer and death registration records. In this âincident usersâ design study, new users of empagliflozin will be compared to the 2 comparison groups. Using propensity scores, individuals in the groups will be matched with similar treatment and clinical history at index date. The incident users will be included in the period 2014-2019, and followed until the end of 2019 or the end of database follow-up. Incidence rates (crude and adjusted) will be presented for each exposure group. Relative risks will be presented as hazard ratios adjusted for relevant variables using the Coxâs proportional hazards model with the time-varying covariate approach. The adjusted hazard ratios and incidence rates will be presented along with 95% confidence intervals for the risk estimates. Sensitivity analyses will be performed.
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Description of Palliative Care Referral Among Patients With COPD in the UK — Jennifer Quint ...
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Description of Palliative Care Referral Among Patients With COPD in the UK
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-08
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Chloe Bloom - Corresponding Applicant - Imperial College London
Bhavandeep Slaich - Collaborator - Imperial College London
Daniel Morales - Collaborator - University of DundeeOutcomes:
Palliative care referrals
⢠mortalityDescription: Technical Summary
We will use CPRD GOLD data linked with HES and ONS to identify patients within CPRD who have COPD. We will determine the proportion of COPD patients who have been referred for Palliative care, year on year, from 2004 to 2014, relative to those who died in that year, and how that proportion has changed over time. We will then use logistic regression to assess whether certain patient characteristics are associated with an increased likelihood of referral for palliative care.
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Development and validation of multimorbidity scores for health services outcomes — Catherine Saunders ...
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Development and validation of multimorbidity scores for health services outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-10
Organisations:
Catherine Saunders - Chief Investigator - University of Cambridge
Silvia (Silva) Mendonca - Corresponding Applicant - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Duncan Edwards - Collaborator - University of Cambridge
Martin Roland - Collaborator - University of Cambridge
Rupert Payne - Collaborator - University of BristolOutcomes:
We will determine medication count based on the number of long-term medications being prescribed at the index date.
We will use linked HES data to determine the occurrence of an unscheduled inpatient hospitalization during the post-exposure follow up period. A hospital admission in this period will be determined using the admission and discharge dates for hospitalizations and the start and end dates for consultant episodes. Unscheduled admissions will be those where the method of admission has an emergency admission code.
Mortality and death date will be obtained from the linked ONS dataDescription: Technical Summary
In this project, we aim to develop new multi-morbidity scores for three different outcomes relevant in health services research (one year mortality, general practice consultations and unscheduled hospital admissions). We will do this using contemporary electronic health records data from the UK. Our multi-morbidity scores are based on a list of conditions relevant to characterize multimorbidity in UK primary care published by Barnett et al. (2012). It is our intention to provide transparent, simple approaches to coding multi-morbidity in CPRD that will be useful for other researchers..
This is a retrospective cohort study (including linked ONS and Basic HES data). A random sample of 300000 adults will be used for multimorbidity score development, with two separate validation cohorts used to evaluate outcomes over 1 and 5 year follow-up periods. Adjusted rate or Cox regression (as appropriate) will be used to model numbers of GP consultations, unscheduled hospitalisation and death, using model coefficients for weighting conditions in the score
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Association between glycated hemoglobin (HbA1c), weight and hypoglycemia to treatment choice and medication adherence in Type 2 Diabetes Mellitus (T2DM) — Jason Gordon ...
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Association between glycated hemoglobin (HbA1c), weight and hypoglycemia to treatment choice and medication adherence in Type 2 Diabetes Mellitus (T2DM)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-15
Organisations:
Jason Gordon - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Jason Gordon - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Iskandar Idris - Collaborator - University of Nottingham
Jorge Puelles - Collaborator - Takeda Europe Ltd
Phil McEwan - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )Outcomes:
Health outcomes: The following outcomes will be derived and analysed:
- 1-year HbA1c change from baseline
- 1-year weight change from baseline
- 1-year hypoglycemia incidence (total and rate per patient year)
- Medication compliance (MPR)
- Medication persistence (PDC; time to first treatment intensification including predictors of persistence)Description: Technical Summary
The objectives of this retrospective cohort study are to characterise associations between HbA1c, weight and hypoglycemia to treatment choice and medication adherence in T2DM. Patient-level data will be extracted from the CPRD, to retrospectively analyse a cohort of T2DM patients (>18 years of age) who were prescribed one of five treatment regimens between 2008 and 2016: OHA monotherapy; OHA dual therapy; OHA triple therapy; GLP-1-based therapy; insulin-based therapy. Outcomes of interest in this study are: 1-year change in HbA1c from baseline; 1-year change in weight from baseline; hypoglycemia incidence (1-year total events and rate); medication adherence, including medication compliance (defined by patients' calculated medication possession ratio, MPR) and medication persistence (defined by patients' proportion of days covered, PDC; and time to treatment intensification).
Univariate and multivariate methods of statistical analysis will characterise the associations between HbA1c, weight and hypoglycemia to treatment choice and medication adherence. Summary descriptive statistics will be generated, characterising patient demographics, clinical and treatment characteristics, and medication use. Stratified descriptive statistics and regression models for medication adherence and HbA1c will be fitted to the data adjusting for the influence of observed covariates (potential confounders) including demographic, clinical and socioeconomic factors, other prescriptions, comorbidities and centre effects.
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Pharmacological Heart Failure Treatment in a Population-Based Cohort using Linked Electronic Health Records — Folkert Asselbergs ...
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Pharmacological Heart Failure Treatment in a Population-Based Cohort using Linked Electronic Health Records
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-22
Organisations:
Folkert Asselbergs - Chief Investigator - University College London ( UCL )
Alicia Uijl - Corresponding Applicant - Utrecht University
Ahmed Ibrahim - Collaborator - University of Oxford
Ahuja Kartik - Collaborator - University of Oxford
Amitava Banerjee - Collaborator - University College London ( UCL )
Arno W Hoes - Collaborator - Maastricht University
Jinsung Yoon - Collaborator - University of Oxford
Kenan Direk - Collaborator - University College London ( UCL )
Mihaela van der Schaar - Collaborator - University of Oxford
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Spiros Denaxas - Collaborator - University College London ( UCL )
Stefan Koudstaal - Collaborator - University College London ( UCL )Outcomes:
Death from cardiovascular causes - Any cause hospitalizations - Any cause mortality - Cardiac arrest with resuscitation - Heart failure specific hospitalizations - Myocardial infarction
Description: Technical Summary
Objective
a. The main objectives of this study are to assess validity of linked EHR data for HF research and to determine effectiveness of different types of pharmacological HF treatment in different subgroups of real-world patients. Both objectives will be achieved by replicating RCTs using linked EHR and by subsequently expanding the dataset beyond selective trial populations.Methods
We will investigate a longitudinal cohort HF patients between 1st January 1998 and 31st March 2016 for:
b. Description of use of pharmacological treatment patterns over time
c. Comparison of estimates of efficacy from RCTs with treatment of angiotensin converting enzyme-inhibitors, beta-blockers, angiotensin-II-receptor blockers or mineralocorticoid receptor antagonists in real world HF patients.
d. Study treatment effects in patients beyond those who are typically enrolled in RCTs, and additional research into patient subgroups, leading to estimates of based on comorbidities and risk factors.Data analysis
Patients will be followed over time to estimate relative risk of mortality and morbidity. We will apply different modern techniques to investigate real world data. First we will replicate intention-to-treat analyses from RCTs, and second we will investigate treatment episodes to replicate an as-treated analysis. We will use inverse probability of treatment weighting to control for confounding.
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Loop diuretic use and risk of adverse outcomes among patients with atrial fibrillation — Jennifer Quint ...
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Loop diuretic use and risk of adverse outcomes among patients with atrial fibrillation
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-14
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Rosita Zakeri - Corresponding Applicant - King's College London (KCL)Outcomes:
Prescription for loop diuretic
⢠Hospitalisation - all cause
⢠Death - all cause
⢠Hospitalisation - cardiovascular cause
⢠Death - cardiovascular causeDescription: Technical Summary
The objective of the proposed study is to describe the clinical characteristics, hospitalisation and mortality rates associated with loop diuretic requirement in a community-based cohort of patients with AF, and with and without a known diagnosis of heart failure. For patients with AF without a HF diagnosis, a first prescription for loop diuretic therapy will be modelled as an indicator variable (prevalence) and time-dependent variable (incidence) after AF diagnosis in adjusted Cox proportional hazards regression analyses to determine the association between loop diuretic use and adverse outcomes. Our main hypothesis is that a subset of patients with AF have undiagnosed HF; these patients may be evident from symptoms that warrant loop diuretic therapy, and may have a similar clinical profile and prognosis as patients with AF and known HF. We will also explore whether there is any disparity in the rates and time delay between loop diuretic prescription and HF diagnosis between males and females with AF.
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Investigating the possible role of BLood eosinophil counts in guiding ANti-inflammatory treatment of COPD exAcerbations (BLANCA) — David Price ...
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Investigating the possible role of BLood eosinophil counts in guiding ANti-inflammatory treatment of COPD exAcerbations (BLANCA)
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-22
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Mandy Ow - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Shreyasee Karnik - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Carole Nicholls - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Gopalan Gokul - Collaborator - Astra Zeneca Inc - USA
Marianna Alacqua - Collaborator - Astra Zeneca Inc - USA
Sadia Halim - Collaborator - Astra Zeneca Inc - USA
Sarang Rastogi - Collaborator - Astra Zeneca Inc - USAOutcomes: none known
Description: Technical Summary
Patients with COPD may experience increased frequency in exacerbations with worsening disease severity. Acute exacerbations are one of the primary manifestations of COPD and account for 50â75% of the costs associated with the disease. The clinical diagnosis of an exacerbation in COPD indicates an acute worsening of lung function and symptoms that may require change in regular treatment.
Although COPD is generally thought of as neutrophilic, recently different inflammatory profiles have been identified. It is now believed that eosinophilic COPD patients represent a different phenotype that responds better to corticosteroid treatment. Antibiotics with/without oral corticosteroids are commonly used in the treatment of moderate and severe COPD exacerbations. The degree of eosinophilic inflammation is related to the degree of OCS improvement in lung function and health status.
Studies suggest that anti-inflammatory treatment in patients with higher blood eosinophils results in favourable outcomes, whereas failure to treat with anti-inflammatory prescriptions results in high treatment failure. Although OCS are relatively inexpensive to prescribe, they are associated with significant long term side effects which, in turn, are associated with significant healthcare resource costs.
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The use and protective effect of antibiotics against complications of infection in patients in primary care: a cohort study using linked data from CPRD, HES, and ONS — Laura Shallcross ...
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The use and protective effect of antibiotics against complications of infection in patients in primary care: a cohort study using linked data from CPRD, HES, and ONS
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-18
Organisations:
Laura Shallcross - Chief Investigator - University College London ( UCL )
Patrick Rockenschaub - Corresponding Applicant - University College London ( UCL )
Andrew Hayward - Collaborator - University College London ( UCL )
Anitha George - Collaborator - University College London ( UCL )
Arnoupe Jhass - Collaborator - University College London ( UCL )
David Prieto-Merino - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Logan Manikam - Collaborator - University College London ( UCL )
Peter Dutey-Magni - Collaborator - University College London ( UCL )
Selina Patel - Collaborator - University College London ( UCL )Outcomes:
Rates of i) GP consultation for infection and ii) antibiotic prescribing
- Description of antibiotic prescribing patterns and the clinical indication for the prescription
- Risk of infection related adverse outcomes in patients with a GP consultation for respiratory tract infection, urinary tract infection, or skin and/or soft tissue infection, comparing patients who were a) prescribed an antibiotic, and b) not prescribed an antibiotic
- Number needed to treat (NNT) with antibiotics to avoid one infection-related adverse outcome
- Risk prediction models to guide clinical decisions about the need for antibiotic treatment for suspected infection in primary care and communication with patientsDescription: Technical Summary
Antibiotic overuse drives antimicrobial resistance. In primary care rates of antibiotic prescribing vary widely, associated with characteristics of the patient and GP prescribing behaviour.
The aim of this study is to investigate whether analyses of patient level characteristics can guide antibiotic prescribing decisions in primary care.
Using data from patients who contributed to CPRD between April 2007 and December 2015, we will describe the diagnosis, antibiotic treatment and clinical outcomes of patients with common infection syndromes. These analyses will be stratified by patient characteristics including: age, gender, social deprivation, selected co-morbidities, obesity and smoking.
In a series of cohort studies of patients with common infection syndromes, we will: a) estimate the rate of adverse outcomes comparing those who were treated with antibiotics to those who were not, using Poisson regression and b) calculate the number needed to treat to avoid one infection related adverse outcome using multi-level logistic regression, taking account of patient's vulnerability through the use of propensity scores. These analyses will be stratified by each of the patient characteristics listed above. This work will be synthesized through models that predict each patient's risk of adverse outcomes, comparing the scenario of antibiotic treatment versus no antibiotic treatment.
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Sex differences in risk factors and health service delivery for cardiometabolic diseases — Sanne Peters ...
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Sex differences in risk factors and health service delivery for cardiometabolic diseases
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-24
Organisations:
Sanne Peters - Chief Investigator - University of Oxford
Sanne Peters - Corresponding Applicant - University of Oxford
Elizabeth Millett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kazem Rahimi - Collaborator - The George Institute for Global Health
Mark Woodward - Collaborator - The George Institute for Global Health
Mei-Man Lee - Collaborator - University of Oxford
Misghina Tekeste Weldegiorgis - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of OxfordOutcomes:
Cardiovascular disease
- Diabetes
- All-cause mortality
- End-stage renal disease
- Heart disease
- Dementia
- StrokeDescription: Technical Summary
There is increasing recognition of clinically meaningful differences between men and women in the occurrence, management and outcomes of non-communicable diseases (NCDs). However, the evidence is inconsistent and incomplete, particularly for major non-cardiovascular conditions such as chronic kidney disease, dementia, diabetes, cancer, and respiratory disease. With this proposal, we will complement and expand our current programme of research on sex differences in cardiovascular diseases to other major NCDs. Our objectives are to 1) quantify the sex-specific associations between the major risk factors and common NDC outcomes: cardiovascular disease, chronic kidney disease, dementia, diabetes, cancer, respiratory diseases and 2) to determine whether there are differences between men and women in guideline-recommended care provided for the primary and secondary prevention of these NCDs. The risk factors that will be used as exposures in objective 1 include blood pressure, smoking status, diabetes, body mass index, lipids, HbA1C, eGFR, albumin, and creatinine. We will assess differences across demographic, socioeconomic, and clinical subpopulations. This research will expand our understanding of sex differences in risk factors for NCDs and will assess whether inconsistencies in health service delivery contribute to the sex differences in the occurrence of NCDs.
Source - and 20 more projects — click to show
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Retrospective Comparative Effectiveness Study Assessing Treatment and Rates of Exacerbation among Chronic Obstructive Pulmonary Disease Subjects in England — Claudia Cabrera ...
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Retrospective Comparative Effectiveness Study Assessing Treatment and Rates of Exacerbation among Chronic Obstructive Pulmonary Disease Subjects in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-22
Organisations:
Claudia Cabrera - Chief Investigator - Astra Zeneca R&D Molndal Sweden
Claudia Cabrera - Corresponding Applicant - Astra Zeneca R&D Molndal Sweden
Celine Quelen - Collaborator - Creativ-Ceutical
Jennifer Quint - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UKOutcomes:
COPD exacerbations; Pneumonia; Mortality.
Description: Technical Summary
For people with chronic obstructive pulmonary disease (COPD), standard maintenance inhaler treatments consist of ICS and long acting bronchodilators. Principal classes of long acting bronchodilators include long-acting beta-2-agonists (LABA) and long-acting muscarinic antagonists (LAMA). Treatment effects are usually measured by a reduction in occurrence of exacerbations and have been mainly studied in randomized controlled clinical trials (RCT). These studies indicate that combining inhaled corticosteroids (ICS) with LABAs and LAMAs provides rapid and sustained improvements that extend beyond monotherapy alone. There is a need for real-world effectiveness data regarding COPD treatment in order to demonstrate that improvements in lung function translate into reductions in exacerbations, hospitalizations, or morbidity. For comparative effectiveness research to impact COPD patients with multiple illnesses, a shift needs to occur from the heavy reliance on controlled efficacy studies in highly selected populations to observational studies with rigorous study design. Electronic medical records or primary health care data such as the CPRD GOLD provide a platform for these observational studies. We will compare the relative effects of triple therapy treatments (ICS/LABA/LAMA) versus LAMA treatment alone on exacerbations in patients with COPD in a real world setting. This study will provide epidemiological data to support RCT design.
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The role of hepatitis B in the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in type 2 diabetes melltius (T2DM) patients. — Germano Ferreira ...
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The role of hepatitis B in the progression of Non-Alcoholic Fatty Liver Disease (NAFLD) in type 2 diabetes melltius (T2DM) patients.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-17
Organisations:
Germano Ferreira - Chief Investigator - Not from an Organisation
Germano Ferreira - Corresponding Applicant - Not from an Organisation
Adrienne Guignard - Collaborator - GSK
Anke Stuurman - Collaborator - P95
Kaatje Bollaerts - Collaborator - P95
Maria Alexandridou - Collaborator - P95
Tom Cattaert - Collaborator - P95
Veronique Bianco - Collaborator - GSK
Yves Horsmans - Collaborator - Catholic University of LouvainOutcomes:
NAFLD-related cirrhosis The primary outcome NAFLD-related cirrhosis is defined, for the purpose of this study, as cirrhosis for which no other cause was identified. The definition is therefore implemented by exclusion, namely as cirrhosis of other aetiology than those defined as study exclusion criteria (alcoholic liver disease, alcoholism, autoimmune liver disease, any viral hepatitis other than HBV, liver transplantation, liver cancer, hemochromatosis, liver failure). The date of onset will be the date of earliest evidence of any cirrhosis. Preliminary code lists for cirrhosis, including those part of the exclusion criteria, are available in the Appendix 2. Liver fibrosis, non-alcoholic hepatocellular carcinoma For exploratory aim 5 and 6 non-alcoholic liver fibrosis and non-alcoholic hepatocellular carcinoma are defined as fibrosis or hepatocellular carcinoma of other aetiology than those defined as study exclusion criteria (alcoholic liver disease, alcoholism, autoimmune liver disease, any viral hepatitis other than HBV, liver transplantation, hemochromatosis, liver failure). The date of onset will be the date of earliest evidence of any fibrosis or hepatocellular carcinoma. Preliminary code lists for non-alcoholic fibrosis and non-alcoholic hepatocellular carcinoma are available in the Appendix 2. Outcome definition algorithm performance A subset of maximum 100 NAFLD-related cirrhosis cases identified in Cohorts 1 to 3 will be selected at random and ascertained through subject profile review, by two independent reviewers, including all available clinical, therapy, and laboratory test recorded in CPRD, to insure the performance of the NAFLD-related cirrhosis classification algorithm. The positive predictive value of the NAFLD-related cirrhosis classification algorithm and the inter-reviewer agreement will be estimated. Based on the positive predictive value, if lower than 90%, case definitions may be refined and additional sensitivity analyses will be performed. Two P95 clinical reviewers (Anke Stuurman, Germano Ferreira) will do the case profile review and Thomas Verstraeten will resolve any disagreement; Prof Yves Horsmans will be consulted in case of the need for further clinical expert adjudication.
Description: Technical Summary
Both Hepatitis B Virus (HBV) infection and non-alcoholic fatty liver disease (NAFLD) can cause liver damage. There is a lack of data on the role of HBV infection in the progression of liver disease in diabetic patients with NAFLD.
The main research question is: does HBV-infection increase the risk of development of, or accelerate the progression to, NAFLD-related stages in patients with type 2 diabetes mellitus (T2DM)?
We propose a cohort study based on health-records of the CPRD population eligible for linkage with HES Admitted Patient Care, from 2000 to the latest CPRD release available at the time of the analyses. Three cohorts will be compared: subjects with T2DM and HBV-infection, subjects with T2DM and without HBV-infection, and T2DM-free subjects with HBV-infection. Due to underdiagnoses of NAFLD, and the high proportion of NAFLD in subjects with T2DM, T2DM will be used as a proxy for NAFLD exposure. Subjects with a history of liver disease unrelated to HBV infection or NAFLD will be excluded. We will look at descriptive data, calculate incidence rate ratios (IRRs) using a Poisson regression model, and explore diseases progression in a time-to-event analysis. The latter models will be adjusted for covariates and sensitivity analyses will be performed to assess and minimise the impact of potential confounders.
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Predicting prostate cancer progression: Associations between routine primary care data and prostate cancer outcomes. — Sam Merriel ...
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Predicting prostate cancer progression: Associations between routine primary care data and prostate cancer outcomes.
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-01
Organisations:
Sam Merriel - Chief Investigator - University of Exeter
Sam Merriel - Corresponding Applicant - University of Exeter
Margaret May - Collaborator - University of Bristol
Richard Martin - Collaborator - University of BristolOutcomes:
Prostate cancer mortality; All-cause mortality; Non-prostate cancer mortality; Spread of disease; Commencing systemic treatment.
Description: Technical Summary
The objective of this study is to establish which risk factors are associated with prostate cancer progression using primary care medical records data. Prostate cancer progression can be defined as the occurrence of one of the following after diagnosis of localised disease; development of metastases, change in treatment, or death. Our retrospective cohort study will include 57,318 men with prostate cancer diagnosed in between 1st January 1987 and 31st July 2016; 22,080 of whom died during the study period. We will use the Clinical Practice Research Datalink (CPRD) to gather information on demographics and risk factors identified a priori, and linked data from the Office for National Statistics (ONS) and the National Cancer Registration and Analysis Service (NCRAS) on cancer stage/grade and mortality. Cox proportion hazard regression and survival analysis using flexible parametric models will be utilised to determine factors associated with mortality in men with prostate cancer accounting for competing risks of other causes of death. This study could be the first step in developing a way to predict which men with prostate cancer will have more aggressive disease. It will inform development of a risk prediction tool to help GPs and specialists advise their patients and inform treatment decisions.
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Comorbidity as a predictor of referral to, and outcome from, joint replacement surgery in primary care patients with newly diagnosed arthritis: a population-based cohort study — Daniel Prieto...
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Comorbidity as a predictor of referral to, and outcome from, joint replacement surgery in primary care patients with newly diagnosed arthritis: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; HES PROMS (Patient Reported Outcomes Measure); ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-15
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Rory Ferguson - Corresponding Applicant - University of Oxford
Alan Silman - Collaborator - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Christine Walker - Collaborator - Keele University
Christopher Edwards - Collaborator - St Woolos Hospital
Cyrus Cooper - Collaborator - University of Southampton
Dahai Yu - Collaborator - Keele University
Edward Burn - Collaborator - Oxford University Hospitals
George Peat - Collaborator - Keele University
John Griffiths - Collaborator - Oxford University Hospitals
Jose M Valderas - Collaborator - University of Exeter
Kelvin Jordan - Collaborator - Keele University
Nigel Arden - Collaborator - University of Oxford
Rafael Pinedo-Villanueva - Collaborator - University of Oxford
Rory Ferguson - Collaborator - University of Oxford
Samuel Hawley - Collaborator - University of Bristol
Sion Glyn-Jones - Collaborator - University of OxfordOutcomes:
First objective:
The primary outcome is validity of the CPRD electronic diagnostic code for hip osteoarthritis.
- To determine whether the diagnostic code is valid, we will seek further information from a sub-group of 100 patients, who will be randomly selected by CPRD from the larger cohort. A questionnaire has been designed, which will be sent to the GPs of the 100 selected patients. The GPs will be requested to complete the questions based on information available in each patient's electronic primary care notes. The questions will relate to the NICE diagnostic criteria for hip osteoarthritis, with questions focusing on symptoms of pain, results of X-rays and referral to secondary care. Depending on the information gained from the questionnaire, each patient's diagnosis will be deemed valid or invalid. If the positive predictive value of the diagnostic codes is >75% (i.e. over 75% of patients have an accurate diagnosis), then we will conclude the diagnostic code is valid and continue with objectives two and three.
Second objective:
The primary outcomes are
(i) Dichotomous outcome of referred or not referred to secondary care (to secondary care for orthopaedic opinion of their diseased joint)
(ii) Time from GP diagnosis of osteoarthritis to referral to secondary care for orthopaedic opinion
(iii) Time from referral to secondary care to receipt of surgery (THR/TKR)
(iv) Time from GP diagnosis of osteoarthritis to receipt of surgery (THR/TKR)
Data on these outcomes will be extracted from CPRDThird objective:
The primary outcome is complication rate in the 90 days following THR or TKR surgery. Included complications are:
- Death
- Venous thromboembolism
- Myocardial infarction
- Stroke
- Anaemia
- Respiratory, urinary tract and wound infectionsThe secondary outcomes are:
- PROMs (Oxford hip score, Oxford knee score, EQ-5D Index and EQ-VAS) (raw score and improvement from pre-op score at 24 months post-operatively)
- Length of hospital stay (for admission for THR/TKR)
- Early (90-day) re-admission rate
- Mortality rate
- Re-operation rate
- Revision surgery rateDescription: Technical Summary
Changes to the UK population demographic have led to a rise in the number of total hip replacement (THR) and total knee replacement (TKR) procedures performed on elderly patients. These patients have an increasing level of comorbidity, which can constrain the benefits of surgery and increase intra-operative and post-operative risks. At present there is limited evidence on the effect of pre-existing comorbidites on benefits and risks from THR and TKR surgery, making decision-making on whether to proceed with surgery difficult. This project aims to investigate the relationship between comorbidity and the likelihood of a patient with arthritis being referred for arthroplasty, and, if surgery is undertaken, the short and medium term outcomes.
Using the Clinical Practice Research Datalink and Hospital Episode Statistics databases, we will interrogate the records of over 100,000 patients aged >65 with a coded GP diagnosis of osteoarthritis or rheumatoid arthritis to assess their baseline levels of comorbidity using a range of metrics, the time taken between diagnosis and surgery, and key outcomes of surgery. Statistical techniques, including survival modelling and multiple regressions, will be used to describe the associations between the outcomes. We hope our results will prove useful to patients and clinicians.
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Assessment of the scientific feasibility of utilizing the CPRD to conduct a randomized point of care trial in COPD patients — Jeanne Pimenta ...
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Assessment of the scientific feasibility of utilizing the CPRD to conduct a randomized point of care trial in COPD patients
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-08
Organisations:
Jeanne Pimenta - Chief Investigator - BioMarin Pharmaceutical Inc.
Jeanne Pimenta - Corresponding Applicant - BioMarin Pharmaceutical Inc.
Achim Wolf - Collaborator - CPRD
Anna Higgins - Collaborator - Not from an Organisation
Daniel Dedman - Collaborator - CPRD
Jennifer Campbell - Collaborator - CPRD
Jennifer Quint - Collaborator - Imperial College London
John Logie - Collaborator - GlaxoSmithKline - UK
Rachael Williams - Collaborator - CPRDOutcomes: none known
Description: Technical Summary
The purpose of this study is to provide the descriptive data necessary for an initial assessment of the potential to conduct future point of care randomised trials in COPD in CPRD practices. We will estimate the number of patients actively enrolled at CPRD practices on July 1st 2016, describe the patient characteristics and estimate the frequency of treatment change in the 6 months prior to the index date as a proxy for understanding how frequently patients will reach clinical equipoise and be eligible for recruitment into a clinical trial. In a cohort of COPD patients who were actively registered in CPRD practices on July 1, 2011 (and whose practice still contributed to CPRD on July 1, 2016), we will describe the distribution of follow-up time, reasons for loss to follow-up and mortality rates for the COPD patients using crude Kaplan Meier curves. Analyses will be conducted separately for practices using the different GP software systems (Vision and EMIS). Additional analyses will be conducted for âresearch activeâ practices, patients who are eligible for linkage with secondary care data, COPD patients with spirometry measurements in their record and patients with a change in maintenance therapy.
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Comorbidities and Medication Use in Patients Diagnosed with Multiple Sclerosis Compared to Patients Without Multiple Sclerosis — Susan Jick ...
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Comorbidities and Medication Use in Patients Diagnosed with Multiple Sclerosis Compared to Patients Without Multiple Sclerosis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-10
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Anders Lindholm - Collaborator - Celgene Ltd
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Guido Falcone - Collaborator - Yale University
John Freeman - Collaborator - Celgene Ltd
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Sally Lee - Collaborator - Celgene LtdOutcomes:
For MS and non-MS patients who were free of the comorbidities and medications described below, at cohort entry, we will follow them forward from the cohort entry data to identify newly diagnosed outcomes and medications (cardiovascular diseases, cancers, respiratory diseases, psychiatric diseases such as depression, infections, and other autoimmune diseases. For medications, we will identify MS treatments as well as treatments for cardiovascular disease and the other comorbidities).
Description: Technical Summary
Using data from the CPRD we will identify patients who were first diagnosed with MS during the years 2001 through 2016 and who have at least 1 year of data in their record before the first MS diagnosis. We will send GP questionnaires for a sample of the MS patients to confirm the diagnosis and obtain information on MS treatments that are not captured in the CPRD Gold, such as infusions. We will match up to 10 patients without MS to each MS patient on age, sex general practice, year of registration in the CPRD, and calendar time. We will describe basic characteristics of the MS and non-MS cohorts in each database at baseline and estimate the risk (cumulative hazard function) of each study outcome at various times of follow-up in both cohorts using the Kaplan Meier method. Each patient in the MS and non-MS cohorts will be followed forward in time and using Byarâs method we will estimate cumulative incidence rates at the end of follow-up of each of the study outcomes, with 95% confidence intervals, stratified by age, sex and year of MS diagnosis.
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Life-Limiting Conditions in Children and Young People: Prevalence and GP involvement — Lorna K Fraser ...
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Life-Limiting Conditions in Children and Young People: Prevalence and GP involvement
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-11
Organisations:
Lorna K Fraser - Chief Investigator - University of York
Lorna K Fraser - Corresponding Applicant - University of York
Bryony Beresford - Collaborator - University of York
Catherine Hewitt - Collaborator - University of York
Roger Parslow - Collaborator - University of Leeds
Sarah Mitchell - Collaborator - University of Warwick
Stuart Jarvis - Collaborator - University of YorkOutcomes:
The primary health outcome is the number of emergency inpatient hospital episodes. The secondary health outcomes are i) the number of hospital readmissions ii) the number of A and E attendances (analyses only undertaken from 2007/8 onwards due to availability of the A & E data) iii) the place of death (if death has occurred)(available from the CPRD GOLD dataset)
Description: Technical Summary
The prevalence of children and young people (CYP) with a Life-Limiting Condition (LLC) is increasing with more than 40,000 CYP currently living with a LLC in England [1, 2]. LLCs are those for which there is no reasonable hope of cure and from which CYP will die. CYP with a LLC typically have complex health care needs and during childhood their care is coordinated by tertiary or community paediatricians and it is unusual for the child's GP to be actively involved. However, the care of these individuals is often transferred back to the GP to coordinate their care when they are no longer eligible for paediatric services. Given that many of these children are now living longer, sometimes into adulthood, this is an increasingly common scenario [3]. This study involves quantitative analyses of routinely collected healthcare data including the Clinical Practice Research Datalink and inpatient hospital data to:
1. Determine the prevalence of children with LLC in primary care data.
2. Describe patterns of GP usage and involvement in children and young people with a LLC in England (0-25 years)
3. To assess the association between the number and regularity of contacts with GP and unplanned hospital admissions/readmissions, A&E attendances and place of death in CYP with a LLC using poisson regression modelling
4. To assess whether there is evidence of increased GP contacts usage or inpatient hospital admissions associated with the transition from paediatric care
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Association between diabetes control and risk of fractures: a follow-up and a nested case control — Christoph Meier ...
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Association between diabetes control and risk of fractures: a follow-up and a nested case control
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-23
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Corresponding Applicant - University of Basel
Christian Meier - Collaborator - University of Basel
Janina Vavanikunnel - Collaborator - University of Basel
Sarah Charlier - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Non-traumatic fractures in diabetes patients.
Description: Technical Summary
We will conduct a follow-up study followed by a 1:4 matched nested case-control analysis in diabetes patients (type 1 or 2) to explore the association between diabetes control (based on HbA1c-levels), diabetes duration, and the risk of low-trauma fractures. In an additional analysis, the association between diabetes medication/medication scheme will be assessed in combination with the diabetes control on the risk of fractures.
Cohort study:
We will identify a cohort of newly diagnosed diabetes patients within the study period (01.01.1995 - 31.12.2015). Patients with type 1 or 2 diabetes must have >3 years of history in the database before their first diabetes code, respectively. We will follow the DM patients until they experience a low-trauma fracture. The time from diabetes diagnose to fracture will be analysed for various categories of HbA1c-levels. The goal of this analysis is to quantify the fracture risk in relation to diabetes duration.Nested case control analysis:
Each diabetes patient who experienced a low-trauma fracture after the diabetes diagnosis will be matched to 4 diabetes patients with no recorded fracture. Cases and controls will be matched on age, sex, general practice, index date, diabetes type, and diabetes duration (follow-up time between diabetes onset and fracture date) by risk set sampling. For our additional analysis on the risk of fractures according to diabetes control and diabetes medication/medication schemes (timing and duration of drug use), only type 2 diabetes patients will be analysed. In this additional study we will match on age, sex, general practice, and index date by risk set sampling, but not on diabetes duration. Patients for the additional analysis are also required to have >3 years of history in the database before their first diabetes code.
The goal of this analysis is to examine the association between diabetes control and the risk of fracture. Medication prescribed to diabetes type 2 patients will additionally be taken into account to assess this association in the mentioned additional analysis.We will perform statistical analysis with SAS version 9.4.
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Assessing the risk of infection among babies born to mothers with Systemic Lupus Erythematosus; a study of the first two years of life. — Denise Elsasser Dietz ...
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Assessing the risk of infection among babies born to mothers with Systemic Lupus Erythematosus; a study of the first two years of life.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-17
Organisations:
Denise Elsasser Dietz - Chief Investigator - Rutgers, The State University of New Jersey
Denise Elsasser Dietz - Corresponding Applicant - Rutgers, The State University of New Jersey
Anne Dilley - Collaborator - Biogen
Demissie Kitaw - Collaborator - Rutgers, The State University of New Jersey
Jeffery (Jeff) Allen - Collaborator - Biogen
Lin Young - Collaborator - Rutgers, The State University of New Jersey
Stephan Schwander - Collaborator - Rutgers, The State University of New Jersey
Susan Eaton - Collaborator - Biogen
Teresa Janevic - Collaborator - Icahn School of Medicine at Mount Sinai
Todd Rosen - Collaborator - Rutgers, The State University of New JerseyOutcomes:
#NAME?
Description: Technical Summary
This study will investigate whether children born to women with Systemic Lupus Erythematosus (SLE) have a higher risk of infection during the first two years of life than children born to healthy women. We will utilize a retrospective cohort analysis using CPRD Gold, the in-patient Hospital Episode Statistics (HES) and the HES Mother-Baby link. Four babies born to healthy women will be matched as controls by birth year (and month, if available) and maternal age at birth. A frequency table will be reported for all infections seen in the exposed population and collapsed into categories bacterial, viral, fungal and other; this will be repeated for the unexposed. Risk ratios and 95% confidence intervals will be reported. We will assess the impact of breastfeeding and preterm birth on infection in the exposed and unexposed. Risk analysis will be conducted for maternal SLE organ involvement, the Systemic Lupus Activity Measure (SLAM) index and medication use during pregnancy. All risk ratios will be calculated for three time periods in the child's life: the neonatal period (birth-28 days), 29 days - 6 months and >6 months to 2 years of life to identify if any relationship persists into early childhood.
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Incretin-based Drugs and the Risk of Adverse Renal Outcomes — Samy Suissa ...
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Incretin-based Drugs and the Risk of Adverse Renal Outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-01
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Brenda R Hemmelgarn - Collaborator - University of Calgary
Dana Attar - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill University
Matthew Secrest - Collaborator - McGill University
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Richeek Pradhan - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
⢠Hospitalization for acute kidney injury ⢠Initiation of dialysis ⢠Death from renal causes ⢠Doubling of baseline creatinine values ⢠Worsening of albuminuria category
Description: Technical Summary
Recent evidence regarding the safety of incretin-based drugs on renal outcomes is conflicting. The SAVOR-TIMI 53 trial of saxagliptin and the FIGHT trial of liraglutide implicated these drugs in adverse renal events and worsened renal function, respectively. However, these safety signals were not replicated in TECOS, the EXAMINE trial found no effect of alogliptin on glomerular filtration rate or initiation of dialysis and SUSTAIN-6 observed that semaglutide reduced the rates of new or worsening nephropathy. Given these conflicting data, there is an urgent need to address the renal effects of incretin-based drugs. To meet this need, we will conduct a retrospective, population-based cohort study. We will identify all type-2 diabetic patients in the CPRD receiving a new prescription for a non-insulin antidiabetic drug (from 2007-2016) and will assign them to time-dependent exposure categories: users of DPP-4 inhibitors, users of GLP-1 agonists, users of â¥2 oral hypoglycaemic agents (OHAs), or patients on other regimens. The rates of hospitalization for AKI and other adverse kidney outcomes (i.e., dialysis, death from kidney disease, doubling of creatinine, or increase in albuminuria category) will be compared between DPP-4 inhibitor users, GLP-1 agonist users, and users of â¥2 OHAs, stratified on chronic kidney disease (CKD) history.
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Parkinson's disease and the risk of epileptic seizures - cohort study with nested case-control analysis — Christoph Meier ...
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Parkinson's disease and the risk of epileptic seizures - cohort study with nested case-control analysis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-08
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Marlene Rauch - Corresponding Applicant - University of Basel
Claudia Becker - Collaborator - University of Basel
Katharina Gruntz - Collaborator - University of Basel
Stephan Ruegg - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Epileptic seizure
- Epilepsy
- Status epilepticusDescription: Technical Summary
Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The pathophysiology of PD is not yet fully understood. Death of dopaminergic neurons in the substantia nigra, degeneration of other neurotransmitter systems and cell loss in other brain stem nuclei and in the cortex are considered as major causes of both motor and non-motor symptoms. In 1928, an inverse relationship between the evolution of newly diagnosed Parkinsonism (a syndrome characterised by bradykinesia, tremor at rest, rigidity and postural instability) and the number of seizures was first described among patients with epilepsy. Since that time, the topic has remained controversial (1-4). In this observational study, we aim to quantify crude incidence rates (IRs) of epileptic seizures among patients with incident PD and among a matched comparison group of individuals without PD, and to assess an incidence rate ratio (IRR) of epileptic seizures in patients with or without PD. In nested case-control analyses embedded in these cohorts, we aim to estimate odds ratios (ORs) of seizure-provoking lifestyle parameters, co-medication and comorbidities among cases with epileptic seizures and matched controls.
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Zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in elderly in England — Kaatje Bollaerts ...
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Zoster vaccine effectiveness against incident herpes zoster and post-herpetic neuralgia in elderly in England
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-24
Organisations:
Kaatje Bollaerts - Chief Investigator - P95
Kaatje Bollaerts - Corresponding Applicant - P95
Germano Ferreira - Collaborator - Not from an Organisation
Margarita Riera-Montes - Collaborator - P95
Maria Alexandridou - Collaborator - P95
Thomas Verstraeten - Collaborator - P95Outcomes:
Herpes zoster
- Post-herpetic neuralgia
- Other herpes zoster complicationsDescription: Technical Summary
Herpes zoster (HZ) is characterized by a unilateral dermatomal rash and pain. The most common complication is post-herpetic neuralgia (PHN).The UK introduced Zostavax in the national immunization program in 2013. The vaccine was routinely offered to 70 year-olds and, as part of the catch-up, to 79 year-olds.
Until now, the vaccine effectiveness has not been studied in the UK general population. We will perform a cohort study, aiming to estimate the effectiveness of zoster vaccination against incident HZ and PHN in elderly in England. Particularly, we propose a cohort study based on health-records of the CPRD population eligible for linkage with HES APC databases and belonging to the birth cohorts: 1943-1946 (routine) and 1934-1937 (catch-up). We will estimate vaccination coverage by birth cohort over time, incidence rates of HZ, PHN and HZ complications and vaccine effectiveness against HZ/PHN and HZ complications. We will additionally explore risk factors for vaccine failure. We will use a Poisson regression model with interaction effects between risk factors of interest and vaccination status as it would allow disentangling HZ/PHN risk factors and risk factors for vaccine failure.
This study will provide evidence on the effectiveness of Zostavax, and might be helpful in optimizing immunization programs.
Source -
Changes in cause of mortality over time in people with chronic respiratory disease in the UK — Jennifer Quint ...
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Changes in cause of mortality over time in people with chronic respiratory disease in the UK
Datasets:GP data, ONS Death Registration Data; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-23
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Benedetta Marchiorello Dal Corno - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UKOutcomes:
Overall mortality; Disease specific mortality.
Description: Technical Summary
This study will investigate whether there have been changes in causes of death in people with chronic respiratory diseases (asthma, COPD, bronchiectasis and IPF) over the past 15 years in the UK. We will use linked CPRD, HES and ONS data to investigate changes in causes of death within each chronic respiratory disease over the past 10 years. We will undertake descriptive analyses to investigate changes in causes of death over time. We will analyse rates of death associated with each chronic lung disease stratified by age and gender. Understanding changes in the causes of death overtime in people with chronic respiratory diseases will help us to better understand the way these people are currently managed and to inform us if we should be managing them in a different way. For example, if more people with COPD are now dying of CVD compared to their respiratory disease then it would provide a reason to increase cardiovascular disease prevention and to better understand cardiovascular disease management in this group.
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Uptake and effectiveness of the seasonal trivalent influenza vaccine in autoimmune inflammatory rheumatic disease patients receiving corticosteroids and disease modifying anti-rheumatic drugs — Abhishek Abhishek ...
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Uptake and effectiveness of the seasonal trivalent influenza vaccine in autoimmune inflammatory rheumatic disease patients receiving corticosteroids and disease modifying anti-rheumatic drugs
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-11
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Abhishek Abhishek - Corresponding Applicant - University of Nottingham
Christian Mallen - Collaborator - Keele University
Georgina Nakafero - Collaborator - University of Nottingham
Jonathan Van-Tam - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Michael Doherty - Collaborator - University of Nottingham
Puja Myles - Collaborator - CPRD
Weiya Zhang - Collaborator - University of NottinghamOutcomes:
Primary care consultations for lower respiratory tract infection requiring antibiotics, influenza, influenza-like illness, or exacerbation of chronic obstructive airway disease (COPD); - Hospitalisation due to influenza, influenza-like illness, pneumonia, or exacerbation of chronic obstructive airway disease; - Death due to pneumonia or influenza; - Number of GP consultations for joint pain, fatigue, fever, vasculitis in the pre-defined periods before and after STIV. Data on these will be extracted from primary care records using Read codes. Hospital Episode Statistics (HES) and ONS data will be used to identify the reasons for hospital admission, and the causes of death respectively. Primary end-points: primary care consultation for lower respiratory tract infection requiring antibiotics Secondary end-points: - Primary care consultation for influenza-like illness - Primary care consultation for exacerbation of COPD - Hospitalization for influenza-like illness or pneumonia - Death due to influenza-like illness, pneumonia, exacerbation of COPD - Temporal trend in the uptake of STIV in AIRD patients on DMARDs and/or immunosuppressive agents - Geographic variation in the uptake of STIV - Primary care consultation for AIRD flare after STIV administration.
Description: Technical Summary
Objectives: (1) To examine whether vaccination with seasonal trivalent influenza vaccine (STIV) reduces the
incidence of influenza like illness and lowers respiratory tract infection, exacerbation of chronic obstructive airway
disease, pneumonia, hospitalization and mortality in auto-immune rheumatic disease (AIRD) patients on corticosteroids or disease modifying anti-rheumatic drugs (DMARDs); (2) To investigate temporal trends and geographic variation in uptake of STIV in this patient group; and (3) To investigate if STIV causes flare of AIRD.
Design: Primary care based cohort study using data from the CPRD.
Study period: 01/09/2006-31/08/2016.
Methodology: Unadjusted GP consultation and hospital admission rate ratios for each outcome and mortality rate ratio will be calculated. This will be adjusted for the propensity of being vaccinated. Adjusted illness and mortality hazard ratios and their 95% confidence intervals will be calculated, and used to compute vaccine effectiveness. Rates of vaccination will be calculated for each year and region and will be stratified by age and AIRD type. The risk of primary care consultation for joint pain, fatigue, fever, vasculitis in the 15 day period before and 90 day period after STIV administration will be compared to that in the rest of the influenza year using self-controlled case series methodology.
Source -
Quantification of the association between chronic kidney disease status and cause-specific hospitalisation: a population-based cohort study in the UK — Dorothea Nitsch ...
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Quantification of the association between chronic kidney disease status and cause-specific hospitalisation: a population-based cohort study in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-17
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Corresponding Applicant - University of Tsukuba
Ben Caplin - Collaborator - UCL Hospital
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sara Thomas - Collaborator - Not from an OrganisationOutcomes:
Outcomes are cause-specific hospitalisations for common conditions, based on HES Admitted Patient Care (APC) records.
Description: Technical Summary
We aim to systematically quantify the association between chronic kidney disease (CKD) and cause-specific hospitalisation in absolute and relative terms. We will use a comparative cohort of 242,349 people with CKD (estimated glomerular filtration rate <60 mL/min/1.73m2 twice for >3 months) who were individually matched to a person without known CKD on the same practice register for age, sex and calendar time between 2004 and 2014. Data derive from practices participating in CPRD who have agreed to be linked to Hospital Episode Statistics. Outcomes are hospitalisations for the following common conditions: myocardial infarction; heart failure; cerebral infarction; pneumonia; urinary tract infection; gastrointestinal bleeding; intracranial bleeding; venous thromboembolism; hip fracture; and acute kidney injury. Follow-up continues for each outcome until the first incidence of that outcome after cohort entry, death, renal replacement therapy initiation, change of practice, last data collection, or 31/03/2014. We will estimate an incidence rate difference for each outcome between those with and without CKD, and estimate a relative risk by Cox regression analysis stratifying a matched pair and adjusting for ethnicity, socio-economic and smoking status, BMI, care home residence, and diagnoses of 17 chronic diseases in Quality Outcome Framework. As secondary outcome, we will describe in-hospital mortality after each cause-specific hospitalisation and crudely compare it between matched patients with and without CKD.
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Comparison of real world outcomes of HF patients in the UK and the USA — Jennifer Quint ...
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Comparison of real world outcomes of HF patients in the UK and the USA
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-30
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Varun Sundaram - Corresponding Applicant - Imperial College LondonOutcomes:
All-cause mortality; Composite of heart failure hospitalisation and all-cause mortality; Composite of all hospitalizations (by diagnostic code and urgency) and mortality (by cause recorded on death certificates).
Description: Technical Summary
As a national sample of current practice, we will use linked CPRD GOLD data with HES and ONS to undertake a cohort study to provide an accurate estimate of the number of people with HF in the UK. Data from the US will be used sourced from US health care administrative database. All-cause mortality and composite of heart failure hospitalisation and mortality will be determined using Cox proportional hazard models. Overall differences in the event rates for pre-specified groups will be assessed using Kaplan- Meier survival curves, and log rank tests. Multivariable Cox proportional hazards regression analysis will be used to estimate differences after adjusting for covariates (Chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, hypertension, coronary artery disease, atrial fibrillation, previous stroke, malignancy, obesity and depression). Each cohort (UK and USA) will be analysed separately. On completion of the analysis, pooled estimates will be compared across the datasets. The information obtained from this study will be used to create prognostic models within each data set (and also in key subgroups of interest in each data-set).
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Is morbidity in the UK expanding or contracting in later life? An exploratory study investigating temporal patterns in morbidity before death using primary care data — Iain Carey ...
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Is morbidity in the UK expanding or contracting in later life? An exploratory study investigating temporal patterns in morbidity before death using primary care data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-21
Organisations:
Iain Carey - Chief Investigator - St George's, University of London
Iain Carey - Corresponding Applicant - St George's, University of London
David Strachan - Collaborator - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Fay Hosking - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - Polycystic Kidney Disease CharityOutcomes:
Morbidity in pre-defined periods before death. We will explore using a count of co-morbidities, existing indices (e.g. electronic frailty index), and customise our own morbidity index to summarise this.
-Markers of health care utilisation (hospital admissions, primary care consultations, prescribing)Description: Technical Summary
It is unclear whether continued increases in life expectancy in the UK have been accompanied by an expansion or contraction of morbidity in later life. To investigate this further, we will use linked ONS mortality data to identify date of death for approximately 200,000 patients from 150 CPRD practices recording up-to-standard data between 2000 and 2015. Additionally, we will identify a comparison group of age-sex matched patients (2 per death, 1 matched on practice) alive at the time of the case death.
We will focus on the last 5 years of life and estimate morbidity in patients, primarily using a broad range of chronic conditions, but additionally using frailty measures. We will compare morbidity between periods to see whether patients who died recently have more morbidity before death than those dying 10-15 years previously. Analyses will control for age at death, which will have increased by approximately 2 years from 2000 to 2015. A matched comparison group will be used to account for any temporal trends in recording.
Our comparison of morbidity across time, will investigate trends by practice region and deprivation. Additional outcomes will include levels of consultations, prescribing and hospital admissions, which have financial implications for the NHS.
Source -
Mortality and exacerbation rates in people with concurrent asthma and COPD compared to people with COPD alone — Jennifer Quint ...
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Mortality and exacerbation rates in people with concurrent asthma and COPD compared to people with COPD alone
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-29
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kieran Rothnie - Collaborator - GlaxoSmithKline - UK
Sophia Turner - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
It is not uncommon for people to have concurrent asthma and COPD, however the effect this has on health status and how common it truly is and whether it is changing over time is not well established. Using CPRD linked with HES and ONS from 2004-2016, we will determine the prevalence of asthma-COPD overlap and how this has changed over time. In addition, we will compare exacerbation rates and mortality in people with COPD-Asthma compared to those with COPD only.
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The risk of depression and anxiety in adults diagnosed with vitiligo compared to the general population, in the UK — Sonia Gran ...
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The risk of depression and anxiety in adults diagnosed with vitiligo compared to the general population, in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-08
Organisations:
Sonia Gran - Chief Investigator - University of Nottingham
Sonia Gran - Corresponding Applicant - University of Nottingham
Alia Ahmed - Collaborator - West Hertfordshire Hospitals NHS Trust
Andrew Thompson - Collaborator - University of Sheffield
Jonathan Batchelor - Collaborator - Derby Teaching Hospitals NHS Foundation Trust
Lu Ban - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Miriam Santer - Collaborator - University of SouthamptonOutcomes:
Depression; Anxiety.
Description: Technical Summary
There is currently a lack of large population-based studies providing reliable estimates of the risk psychological co-morbidity associated with vitiligo in the UK. It is thought that psychological trauma may precede onset of vitiligo in some cases and contribute to the aetiology of the condition but trauma may also follow diagnosis due to the cosmetic burden, lack of cure and unpredictable prognosis of vitiligo. The aim of this study is to determine the risk of depression and anxiety in people with vitiligo in the UK before and after diagnosis of vitiligo. We will use Hospital Episode Statistics linked Clinical Practice Research Datalink records to establish a cohort of people 18 years or older who have a first clinical diagnosis of vitiligo between 1st April 1997 and 31st December 2015. We will use logistic regression to quantify the risk of depression and anxiety 2 years prior and 2 years after diagnosis in people with vitiligo compared to people without the condition adjusting for potential confounders such as other skin and long-term conditions and examine how this risk varies by age of diagnosis, sex, ethnicity and social deprivation.
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Ocular morbidity associated with Giant Cell Arteritis and Polymyalgia Rheumatica: a controlled cohort study using the UK Clinical Practice Research Datalink — Alexander MacGregor ...
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Ocular morbidity associated with Giant Cell Arteritis and Polymyalgia Rheumatica: a controlled cohort study using the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-05-15
Organisations:
Alexander MacGregor - Chief Investigator - University of East Anglia
Max Yates - Corresponding Applicant - University of East Anglia
Allan B Clark - Collaborator - University of East Anglia
Richard A Watts - Collaborator - Ipswich Hospital NHS TrustOutcomes:
Blindness AION Optic atrophy Cataract surgery Glaucoma Death
Description: Technical Summary
The objective is to document the rate of ocular morbidity attributable to a diagnosis of polymyalgia rheumatica (PMR) and or giant cell arteritis (GCA) in a longitudinal community setting, including blindness, anterior ischaemic optic neuropathy (AION), optic atrophy, cataract, and glaucoma. It is anticipated that around 10% patients with PMR will develop GCA during follow up (analysis of the data will allow us to clarify this figure).
These will be analysed as a separate groups: PMR alone, GCA alone and those with PMR who develop GCA (termed PMR/GCA).
This will follow two stages:
Stage 1 (analysis of cases and controls):
a) We will examine the absolute rate of ocular morbidity in cases and controls
b) Using survival methodology risk factors that influence the rate of ocular morbidity relative to the comparison cohorts will be explored.
c) Examine the influence of aspirin, statins, beta blockers and ACE inhibitors on ocular morbidity both prior to and after the diagnosis date, treating these exposures as time dependent covariates.
Stage 2 will be confined to those in the disease cohort. In this analysis we will examine the relationship between the use of different glucocorticoid (GC) regimens and ocular morbidity using survival analysis.
Source
2017 - 04
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Risk of developing chronic obstructive pulmonary disease or lung cancer in smokers taking enzyme-inducing antiepileptic drugs — Anne B. Taegtmeyer ...
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Risk of developing chronic obstructive pulmonary disease or lung cancer in smokers taking enzyme-inducing antiepileptic drugs
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
Anne B. Taegtmeyer - Chief Investigator - University of Basel
Christoph Meier - Corresponding Applicant - University of Basel
Andreas Zeller - Collaborator - University of Basel
Daphne Reinau - Collaborator - University of Basel
Joerg D Leuppi - Collaborator - Cantonal Hospital Baselland
Stephan Kraehenbuehl - Collaborator - University of Basel
Stephan Ruegg - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Development of chronic obstructive pulmonary disease (primary outcome); Development of lung cancer (primary outcome)
Description: Technical Summary
The objectives of the study are to determine whether the use of enzyme-inducing antiepileptic drugs (AEDs) increases the risk of developing COPD or lung cancer in people who smoke. The study is a hypothesis-driven, matched case-control study, where cases are smokers taking AEDs who have developed COPD or lung cancer and controls are smokers taking AEDs who have not developed COPD or lung cancer. In order to evaluate the association between these smoking-related diseases and the use of enzyme-inducing AEDs (reference: non-enzyme-inducing AEDs), we will conduct conditional logistic regression analyses and assess relative risk estimates as odds ratios (ORs) with 95% confidence intervals (CIs).
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Blood eosinophilia as a biomarker for response to inhaled corticosteroids in COPD. — Frank de Vries ...
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Blood eosinophilia as a biomarker for response to inhaled corticosteroids in COPD.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Anthonius de Boer - Collaborator - Utrecht University
Dionne Braeken - Collaborator - Utrecht University
Frits Franssen - Collaborator - CIRO
Miel (Emiel) Wouters - Collaborator - CIRO
Olorunfemi Oshagbemi - Collaborator - Utrecht UniversityOutcomes:
Acute exacerbations of COPD; COPD Hospitalisation; All-cause mortality.
Description: Technical Summary
Chronic obstructive pulmonary disease (COPD) is a medical condition characterized by enhanced airway inflammation, and is known to be responsible for mortality and morbidity of millions of individuals worldwide. While traditionally lymphocytes, macrophages and neutrophils were considered key players in the inflammatory process of COPD, recent findings suggest that eosinophils have a key role in the disease pathophysiology. Exacerbations of COPD are the primary outcome as these greatly affect a patients' quality of life. The benefits of inhaled corticosteroids (ICS) to reduce exacerbations have mainly been observed in patients having eosinophil airways inflammation. Thus, the purpose of this study is to evaluate the association between the use of ICS among patients with or without blood eosinophilic inflammation, and the risk of exacerbations. This study will be a cohort study of all users of ICS. The primary outcome of the study will be a COPD exacerbation (secondary outcomes include: COPD-related hospitalizations or death). We will use Cox regression analysis to identify the risk of exacerbations, hospitalisation and all-cause mortality adjusting for relevant confounders, among patients with different blood eosinophil levels, and Kaplan Meier curves will be used to show the difference in survival time. Exposure to ICS will be determined time-dependently.
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Autoimmune diseases and risk of glioma — Christoph Meier ...
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Autoimmune diseases and risk of glioma
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-09
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Katharina Sahm - Collaborator - University of Heidelberg
Michael Leitzmann - Collaborator - University of Regensburg
Michael Platten - Collaborator - University of Heidelberg
Peter Hau - Collaborator - University of Regensburg
Ralf Linker - Collaborator - University of Regensburg
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
The exposure of interest in this study will be Autoimmune Disease (AD). We will assess AD according to the following list of diseases in Harrison's Principles of Internal Medicine, which includes coding for Graves' disease, Hashimoto thyroiditis, autoimmune polyglandular syndrome, type 1 diabetes mellitus, insulin-resistant diabetes mellitus, Addison's disease, pemphigus vulgaris, pemphigus foliaceus, dermatitis herpetiformis, autoimmne alopecia, vitiligo, autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura, pernicious anaemia, myasthenia gravis, multiple sclerosis, Guillan-Barre syndrome, Stiff-man syndrome, acute rheumatic fever, sympathetic ophthalmia, Goodpasture's syndrome, systemic lupus erythematosus, rheumatoid arthritis, systemic necrotizing vasculitis, Wegener's granulomatosis, antiphospholipid syndrome, Sjogren's syndrome and additionally Crohn's disease, ulcerative colitis, psoriasis, sarcoidosis, systemic sclerosis, primary biliary cirrhosis, chronic rheumatic heart disease, discoid lupus erythematosus, localised scleroderma, ankylosing spondylitis, haemorrhagic proctitis, polymyalgia rheumatica, Reiter's disease, Dupytren's disease, amyotrophic lateral sclerosis, and induratio penis plastica and celiac disease. A patient will be considered to have an AD if they have any code for one of the diseases listed above at least 1 year prior to the first glioma diagnosis.
Description: Technical Summary
Using data from the CPRD, we intend to perform a 1:10 matched case-control analysis to explore the association between AD and risk of glioma. AD exposure will be defined as the presence of any autoimmune disease at some time one or more years before the diagnosis date of the glioma. Controls will be matched to cases on age, sex, calendar time, general practice, and number of years of active history in the CPRD prior to the index date. Relative risks will be estimated by conducting conditional logistic regression analyses to determine odds ratios (ORs) with 95% confidence intervals (CIs) of glioma in relation to AD. Analyses will be adjusted for potential confounders and only factors altering the risk of glioma by >10% will be included in the final multivariate analysis.
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Unintended effects of novel oral anticoagulants (NOAC) vs warfarin in real world settings — Julia Hippisley...
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Unintended effects of novel oral anticoagulants (NOAC) vs warfarin in real world settings
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-05
Organisations:
Julia Hippisley-Cox - Chief Investigator - University of Oxford
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Carol Coupland - Collaborator - University of Nottingham
Yana Vinogradova - Collaborator - University of NottinghamOutcomes:
#NAME?
Description: Technical Summary
Objective:
The study will compare in patients prescribed different types of novel anticoagulant drugs (NOAC) the risks of major bleeding requiring hospitalisation with those in patients prescribed warfarin.Methods:
This will be a cohort study following patients who received anticoagulant prescription (NOAC or warfarin) between 1 September 2008 and 1 September 2016. We will use new-user design so patients with anticoagulant prescriptions in the previous 12 months will be excluded. Outcomes will be hospitalisations and deaths identified from HES and ONS mortality data. Primary outcomes will include gastrointestinal and intracranial bleed. Secondary outcomes will include ischaemic stroke and venous thromboembolism (VTE).Analysis:
Exposure to different NOAC (dabigatran, rivaroxaban and apixaban) will be compared with exposure to warfarin using a Cox regression analysis. The results will be adjusted for potential confounders evaluated at the date of the first prescription.
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Prophylactic (Risk-reducing) Mastectomy Rates in the UK: Analysis of the Clinical Practice Research Datalink — Alexander Liede ...
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Prophylactic (Risk-reducing) Mastectomy Rates in the UK: Analysis of the Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-02
Organisations:
Alexander Liede - Chief Investigator - Amgen Ltd
Leroy Sandrine - Corresponding Applicant - Amgen Ltd
Dafydd Gareth Richard Evans - Collaborator - Imperial College London
Justyna Amelio - Collaborator - GSKOutcomes:
Preventive mastectomy (i.e. before any breast and/or ovarian cancer, or any type of cancer)
Description: Technical Summary
Familial breast cancer is defined as occurring in people with one or more family members affected by breast, ovarian, or a related cancer such as primary peritoneal cancer. About 5% of breast cancers can be attributed to inherited mutations in specific high risk genes (BRCA1&2, and TP53). According to current NICE guidelines in the UK, preventive mastectomy is one of the breast cancer risk reduction strategies that can be proposed to BRCA1, BRCA2 and TP53 mutation carriers. This study will examine incidence rates (per 1000 women per month and per year) of prophylactic (risk-reducing) mastectomies in a representative cohort of women living in the UK from the Clinical Practice Research Datalink (CPRD) database since database conception in 1987 to the last available data point in January 2017. Incidences rates will be estimated on cohorts of (a) women until censoring event such breast and/or ovarian cancer, or in situ breast cancer, (b) women until censoring event such any type of cancer. Incidence rate will also be estimated depending on women age (with a direct standardization on the UK population) and if they belong to a high-risk group (BRCA1&2, and TP53, family history of breast of/and ovarian cancer).
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Rotavirus vaccine effectiveness against all cause medically attended acute gastroenteritis and hospitalizations in children in England — Margarita Riera...
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Rotavirus vaccine effectiveness against all cause medically attended acute gastroenteritis and hospitalizations in children in England
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-02
Organisations:
Margarita Riera-Montes - Chief Investigator - P95
Margarita Riera-Montes - Corresponding Applicant - P95
Germano Ferreira - Collaborator - Not from an Organisation
Kaatje Bollaerts - Collaborator - P95
Thomas Verstraeten - Collaborator - P95
Tom Cattaert - Collaborator - P95
Tom De Smedt - Collaborator - P95Outcomes:
Incidence of medically-attended acute gastroenteritis (GP level and hospitalizations) - Rotavirus vaccination coverage - Incidence of aetiology-specific medically attended acute gastroenteritis - Incidence of intussusception.
Description: Technical Summary
Rotavirus is the main cause of severe acute gastroenteritis (AGE) in children. Rotavirus vaccines have been available since 2006, and their introduction in the National Immunization Programme (NIP) was recommended by WHO the same year. The UK introduced rotavirus vaccination in July 2013, and recent studies have already shown an impact in the reduction of all cause acute gastroenteritis and rotavirus disease in children. However, these studies used an ecological study design, but without attempting to measure directly rotavirus vaccine effectiveness.
With this study, we aim to estimate both the direct and indirect effects of rotavirus vaccination against all cause and cause-specific medically-attended acute gastroenteritis (MAAGE) in England using the CPRD and HES APC databases. This will be a retrospective observational study using a cohort design including all subjects registered in CPRD in or after January 2010. Episode rate ratios comparing the vaccinated to the unvaccinated will be calculated to estimate vaccine effectiveness (VE). VE will be calculated as VE=1-RR for RR<1 and VE=1/RR-1 for RR>1 and expressed as percentage. Episode rate ratios comparing the population before and after vaccination introduction will be calculated to estimate impact. Confidence intervals will be based on the exact binomial Clopper-Pearson method.
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The Burden of Skin Cancer in UK Primary Care 2004-2014: a Time-Trend Analysis from the Clinical Practice Research Datalink. — Fiona Walter ...
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The Burden of Skin Cancer in UK Primary Care 2004-2014: a Time-Trend Analysis from the Clinical Practice Research Datalink.
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-20
Organisations:
Fiona Walter - Chief Investigator - University of Cambridge
Fatima Mirza - Corresponding Applicant - University of Cambridge
Anas El Turabi - Collaborator - University of Cambridge
Michael Radford - Collaborator - University of Cambridge
Yin Zhou - Collaborator - University of CambridgeOutcomes:
The primary outcome will be: Prevalence for the study end year (2014) will be determined by the presence of a skin cancer medcode (as defined by the appendix) in the patient's history. This is consistent with Cancer Research UK's definition of skin cancer prevalence as those who are living with or surviving cancer at a particular point in time24. The denominator will be the mid-year CPRD population in 2014. Incidence will be defined as a first-ever MM, BCC, or SCC medcode in their file between January 1, 2004 and December 31, 2014 amongst patients with an active registration at any point between January 1, 2004 and December 31, 2014. Denominators for incidence will be obtained from year-specific CPRD denominator files. To avoid misclassifying a patient as an incident case when they are an ongoing case that has transferred into the CPRD cohort, only patients with at least one year of history in CPRD will be considered. All-cause mortality will be calculated as the age-standardised mortality rate, using dates of death for patients who have died according to ONS data. All-cause mortality rate is defined as the number of deaths amongst patients with a history of a skin cancer diagnosis medcode.
Description: Technical Summary
This work aims to quantify the burden of skin cancer in UK primary care and to inform system-level policies in skin cancer management. It aims to use primary care data from the Clinical Practice Research Datalink (CPRD) to study the epidemiology and primary health care burden of melanoma and non-melanoma skin cancers in a UK primary care population.
A retrospective cohort analysis will be conducted to estimate the age-adjusted incidence, prevalence, and all-cause mortality of the three commonest skin cancers - cutaneous melanoma (CM), squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) - over a ten-year timeframe (2004-2014).
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The Prevalence and Clinical Burden of Primary Chylomicronaemia in the UK — Riyaz Patel ...
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The Prevalence and Clinical Burden of Primary Chylomicronaemia in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-09
Organisations:
Riyaz Patel - Chief Investigator - Barts Health and UCLH NHS Trusts
Spiros Denaxas - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Laura Pasea - Collaborator - University College London ( UCL )Outcomes:
Primary chylomicronaemia
- Health service utilisation
- All-cause mortality
- Abdominal pancreatitis
- Abdominal pain
- Diabetes
- Stable angina
- Unstable angina
- Myocardial infarction
- Unheralded coronary heart disease death
- Cardiac arrest/ sudden cardiac death
- Heart failure
- Transient ischaemic attack
- Ischaemic stroke
- Intracerebral haemorrhage
- Subarachnoid haemmorhage
- Peripheral arterial disease
- Abdominal aortic aneurysmDescription: Technical Summary
Using linked electronic health records comprising of CPRD, hospital episode statistics (HES), and national mortality registry (ONS) data sources, the objectives of the study are to (1) identify preliminary estimates of cases with Primary chylomicronaemia (PC) through a set of descriptive analyses of patients in with elevated triglyceride levels (e.g. >8.4mmol/L) and the presence/absence of related conditions (acute pancreatitis and obesity), (2) develop a phenotype algorithm for identifying cases with PC and sub-phenotypes of differing specificity for PC by varying the threshold of triglyceride levels as well as age cut points and disease definitions. (3) evaluate the burden of PC in the UK through calculating prevalence, standard mortality ratios, and rates of primary and secondary healthcare usage, (4) estimate the risks of acute pancreatitis and abdominal pain in PC patients compared with age and gender matched controls without PC and (5) estimate the risks of type 1 and type 2 diabetes and 12 different cardiovascular endpoints in PC patients.
For objectives (4) & (5) we will use Kaplan Meier plots to estimate cumulative incidence and Cox proportional hazards models, adjusted for confounders, to estimate hazard ratios of the endpoints.
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An observational retrospective cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid use and the related cost impact on patients in the OPCRD / CPRD databases — David Price ...
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An observational retrospective cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid use and the related cost impact on patients in the OPCRD / CPRD databases
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-02
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Shreyasee Karnik - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Elizabeth Gardener - Collaborator - Cambridge Research Support Ltd.
Erica Velthuis - Collaborator - PPD - UK
Frank J Trudo - Collaborator - Astra Zeneca Inc - USA
Trung Tran - Collaborator - Astra Zeneca Inc - USA
Xiao Xu - Collaborator - Astra Zeneca Inc - USAOutcomes:
Type 2 diabetes mellitus - Glaucoma - Depression/anxiety - Osteoporosis/osteoporotic fractures - Sleep apnoea - Pneumonia - Hypertension - Sleep disorders - Dyslipidaemia - Weight gain - Cardiovascular disease - Peptic ulcer disease - Cataracts - Chronic kidney disease
Description: Technical Summary
Long term use of oral corticosteroids (OCS) has been associated with increased risk of chronic conditions such as diabetes, osteoporosis, hypertension and cataracts. Previous research found an association between OCS use and morbidity among patients with severe asthma. Research by the Observational and Pragmatic Research Institute (OPRI) in patients with COPD and comorbid type 2 diabetes mellitus suggested that inhaled corticosteroid (ICS) therapy may have a negative impact on diabetes control and that patients prescribed higher cumulative doses of ICS may be at greater risk of diabetes progression. However, previous studies examining OCS use did not explore the effects of long term total exposure in a broader patient population, and did not provide specific OCS doses where the risk of comorbid disease onset significantly increased.
The aim of this study is to investigate the impact of long-term OCS exposure defined as: the total dose (g); categorised into courses per year, average total daily dose (mg/day) and total duration of exposure and current OCS exposures on disease onset, burden and healthcare resource utilisation (HRU) over a minimum two-year timescale in a broad patient population and also in a subgroup of patients with asthma. Disease conditions of interest are type 2 diabetes mellitus, osteoporosis/ osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain, depression/anxiety as primary and pneumonia, cataracts, sleep disorders, cardiovascular disease, chronic kidney disease, dyslipidaemia and peptic ulcer disease as secondary outcomes.
Different time-dependent OCS exposure measures will be explored. For each corticosteroid-related condition, multivariable Cox proportional hazard models will be fitted separately for each of the time-dependent OCS exposure measures. We will explore the independent predictive ability of each exposure measure in the models. To determine critical OCS dose thresholds, total dose and daily dose will be categorised into relevant levels, and the risk of developing the outcome of interest will be compared between corticosteroid arm and control arm. The HRU outcomes and associated costs will be calculated as annualised HRU and annualised costs for each of the outcomes of interest.
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Social determinants of uptake of maternal influenza and pertussis vaccine — Helen McDonald ...
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Social determinants of uptake of maternal influenza and pertussis vaccine
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
Helen McDonald - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Helen McDonald - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Albert J. van Hoek - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Anu Jain - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Christopher Rentsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Gayatri Amirthalingam - Collaborator - Public Health England
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeongeun Bak - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health EnglandOutcomes:
Uptake of maternal influenza vaccine; Uptake of maternal pertussis vaccine.
Description: Technical Summary
Addressing inequalities in vaccine uptake to prevent infections is a key priority for public health. In England, current surveillance methods provide little information about social factors associated with vaccine uptake. This project will use linked electronic health records and a cohort study design to investigate the association between social factors and uptake of both flu and pertussis vaccine in pregnancy. Inactivated influenza vaccine was introduced for pregnant women in England in 2010, and maternal pertussis vaccination was introduced in October 2012. Using a cohort study design and multivariable Poisson regression, we will identify the social determinants of uptake of each vaccine. The results of this project will enhance existing surveillance methods and should help to address vaccine-related health inequities. We will also report on uptake of both vaccines by year and by trimester of pregnancy.
Source - and 12 more projects — click to show
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Sub-optimal Asthma Control in patients treated with medium or high fixed dose combination of Inhaled Corticosteroid and Long Acting Beta-Agonists in the United Kingdom's Clinical Practice Research Datalink — Emil Loefroth ...
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Sub-optimal Asthma Control in patients treated with medium or high fixed dose combination of Inhaled Corticosteroid and Long Acting Beta-Agonists in the United Kingdom's Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-20
Organisations:
Emil Loefroth - Chief Investigator - NOVARTIS
Valentino Conti - Corresponding Applicant - Not from an Organisation
Dorothy Keininger - Collaborator - NOVARTIS
Hui Cao - Collaborator - NOVARTIS
Ismail Kasujee - Collaborator - NOVARTIS
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Paul McDwyer - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Robert Fogel - Collaborator - NOVARTISOutcomes:
Primary: to identify the predictors of sub-optimal asthma control in patients treated with medium and high fixed dose combination of ICS/LABA
- Secondary: To assess the percentage of sub-optimally controlled asthma patients
- Secondary: To describe patients' treatment pathways following the first sign of asthma sub-optimal control in medium or high ICS/LABA
- Secondary: To describe Health Care Resource Utilization (HCRU) in sub-optimal controlled patients compared to controlled patients, in the one-year period after the index prescription.Description: Technical Summary
The primary objective is to identify the predictors of asthma sub-optimal control, among all patients newly treated with medium or high dose ICS/LABA in a fixed dose combination (FDC) in primary care, in their first year of follow-up. The secondary objectives are to identify and describe the two groups of patients controlled and sub-optimally controlled regarding demographic and clinical characteristics, treatment pathways following the first sign of asthma sub-optimal control, and Health Care Resource Utilization (HCRU) in the one-year period after the index prescription.
The cohort of patients with asthma newly treated with an ICS/LABA FDC between 01 January 2007 and 31 December 2014 (or the latest date available in both CPRD and HES at the time of data access) will be selected among the Clinical Practice Research Datalink (CPRD) subset of patients linking with Hospital Episode Statistics (HES) dataset. A multivariable Cox model will be used to identify the predictors of sub-optimal asthma control in the primary objective, and descriptive statistics will be computed for the secondary objectives. All the analyses will be carried out separately for the two sub-cohorts of patients starting with medium or high dose of ICS/LABA FDC.
Source -
Unmet Need and Time Waiting for Intervention with Specialist Therapy in Asthma — Chris D Poole ...
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Unmet Need and Time Waiting for Intervention with Specialist Therapy in Asthma
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-09
Organisations:
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Alicia Gayle - Corresponding Applicant - Imperial College London
Birgit Voelker - Collaborator - Boehringer-Ingelheim International GmbH
Gavin Chiu - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
John Blakey - Collaborator - University of Nottingham
Michael Baldwin - Collaborator - Boehringer-Ingelheim International GmbH
Nikco Hau - Collaborator - Boehringer-Ingelheim GermanyOutcomes:
For patients eligible for referral, the time to first respiratory out-patient visit/referral
- The association between medication use and asthma control
- Average GP visit duration
- The proportion of patients meeting the criteria for specialist referral
- The proportion of patients referred to respiratory outpatients
- Rate of GP visits
- Patterns of use of chronic medication for patients receiving high dose therapies
- Factors related to asthma management in secondary care
- Rate of hospital admissions
- Rate of short-acting therapies prescriptions
- Rate of referralsDescription: Technical Summary
This study is a non-interventional cohort study using existing data provided by the Clinical Practice Research Datalink (CPRD), to gain detailed insights on the waiting time between eligibility and for referral to secondary care for patients treated with additional therapies for asthma. The drivers of a potential delay in referral to secondary care management have yet to be investigated. The main objective of this study is to describe the time to referral and understand the factors associated with length of time waiting for referral to secondary care. Comorbidities and demographic information will be described for the groups of patients initiated on different therapies and survival analysis will be used to estimate the average time to referral and associated risk factors for delay. The results from this study will be used to support the scientific understanding of how therapy guidelines are adhered to in primary care.
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Topical corticosteroids and risk of type 2 diabetes: a nested case-control study — Sonia Gran ...
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Topical corticosteroids and risk of type 2 diabetes: a nested case-control study
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-09
Organisations:
Sonia Gran - Chief Investigator - University of Nottingham
Yuki Andersen - Corresponding Applicant - Copenhagen University Hospital Herlev and Gentofte
Alexander Egeberg - Collaborator - Copenhagen University Hospital Herlev and Gentofte
Filip Knop - Collaborator - Copenhagen University Hospital Herlev and Gentofte
Gunnar Gislason - Collaborator - Copenhagen University Hospital Herlev and Gentofte
Hywel Williams - Collaborator - University of Nottingham
Jacob Thyssen - Collaborator - Copenhagen University Hospital Herlev and Gentofte
Lone Skov - Collaborator - University of Copenhagen
Lu Ban - Collaborator - University of Nottingham
Nicholas Francis - Collaborator - Cardiff UniversityOutcomes:
Type 2 diabetes
Description: Technical Summary
Hyperglycaemia and type 2 diabetes (T2D) are established adverse effects of systemic corticosteroids, however it is not yet known whether topically applied corticosteroids increase the risk of T2D. Few studies have investigated this association and have found conflicting results. The aim of this study is to assess the association between the use of topical corticosteroids and T2D in the UK. We will use CPRD records to establish a cohort of adults aged 18 years or older who have a first diagnostic code for T2D between January 1st 2007 and December 31st 2015. The study cases will be matched with a randomly selected control population without T2D, based on sex, age at diagnosis and GP practice. We will identify all prescriptions of topical corticosteroid agents given before the diagnosis or pseudodiagnosis, and based on a case-control design we will calculate crude and adjusted odds ratios using conditional logistic regression models. Relevant covariates are socioeconomic status, body mass index, smoking, psoriasis, atopic dermatitis and other administrations of corticosteroids, as these factors may be associated with the exposure, and may be an independent risk factor for the outcome. Age and gender are also potential confounders, however these will be controlled for by the matching process.
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Incidence of liver failure and non-viral hepatitis in Multiple Sclerosis (MS) patients and in the general population - a study using the CPRD — Dvora Frankenthal ...
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Incidence of liver failure and non-viral hepatitis in Multiple Sclerosis (MS) patients and in the general population - a study using the CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
Dvora Frankenthal - Chief Investigator - Teva Pharmaceuticals Ltd
Dvora Frankenthal - Corresponding Applicant - Teva Pharmaceuticals Ltd
Sigal (Sigalit) Kaplan - Collaborator - Teva Pharmaceuticals LtdOutcomes:
Incidence of liver failure and non-viral hepatitis in:
(a) Multiple Sclerosis patients;
(b) the general population.Description: Technical Summary
Liver test abnormalities in multiple sclerosis (MS) patients have been reported by the literature and the possibility remains that MS itself or environmental factors associated with MS could increase the risk of liver injury in these patients. This study is being initiated in the context of the routine pharmacovigilance activities that include constant monitoring of safety reports on all marketed products. This study will estimate the incidence rates of liver failure and non-viral hepatitis in MS patients and in the general population in order to obtain a reference incidence rate for Teva's safety data. The study population will comprise individuals who had a diagnosis of MS during the study period between the dates of 01/01/1999 until the present, i.e. until latest available data. Patients will enter this cohort and will be followed from the first MS event date. The general population will be defined as all acceptable patients registered in the CPRD database at any time during the study period. The distribution of the incidence rate of liver failure and non-viral hepatitis will be calculated by age groups, sex, and year.
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Prescribing Pathways to Triple Therapy in Chronic Obstructive Pulmonary Disease — Joseph Kim ...
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Prescribing Pathways to Triple Therapy in Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-02
Organisations:
Joseph Kim - Chief Investigator - IQVIA - UK
Melissa Myland - Corresponding Applicant - IQVIA - UK
Alessandra Venerus - Collaborator - IQVIA Solutions Italy S.r.l
Caroline O'Leary - Collaborator - IQVIA Ltd
Claudia Cabrera - Collaborator - Astra Zeneca R&D Molndal Sweden
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Hans Petri - Collaborator - Petri Consulting Ltd
Jennifer Quint - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UK
Rachel Tham - Collaborator - IQVIA Ltd
Shaila Ballal - Collaborator - Pearl Theraputics
Ulf Holmgren - Collaborator - Astra Zeneca Inc - USAOutcomes:
COPD exacerbations - Adherence - Healthcare resource utilization - Treatment pathways
Description: Technical Summary
This study will examine pathways to triple therapy in COPD and how patient factors (such as exacerbations and symptom score) influence treatment pathways. Adherence will be assessed and evaluated in relation to exacerbation and healthcare resource utilisation. Changes in therapy and eosinophil levels will also be ascertained. COPD cases, approximate disease severity, symptom score, and exacerbations will be identified from proxy indicators due to known issues relating to data completeness[1,2].
The number and proportion of patients on triple therapy and on distinct pathways will be determined. Time to first prescription will be estimated using Kaplan-Meier survival analysis and reported as cumulative proportions alongside the survival curve. The influence of factors (number of exacerbations, symptom score, lung function, phenotype) on choice of pathway leading to triple therapy will be initially explored using bivariate analyses (e.g., comparisons of means, medians or proportions as appropriate between different pathways). A multinomial logistic regression model may be employed as a multivariable analysis of factors predicting pathways. The analysis of pathways of stepping down from triple therapy after initiation will include proportion (%) with 95% confidence intervals and Kaplan-Meier survival analysis of time to stepping down.
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Interruption of Renin-Angiotensin-Aldosterone System Inhibition Treatment and Associations with Adverse Outcomes — David Gilbertson ...
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Interruption of Renin-Angiotensin-Aldosterone System Inhibition Treatment and Associations with Adverse Outcomes
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
David Gilbertson - Chief Investigator - CDRG
David Gilbertson - Corresponding Applicant - CDRG
Akhtar Ashfaq - Collaborator - Astra Zeneca Inc - USA
Heng Yan - Collaborator - CDRG
James Wetmore - Collaborator - CDRG
Jiannong Liu - Collaborator - CDRG
Laura Horne - Collaborator - Astra Zeneca Inc - USA
Robert LoCasale - Collaborator - Astra Zeneca Inc - USA
Sharon MacLachlan - Collaborator - Evidera, Inc
Tanya Natwick - Collaborator - CDRG
Xinyue Wang - Collaborator - CDRG
Yi Peng - Collaborator - CDRGOutcomes:
Hyperkalemia; Heart failure hospitalizations; Acute kidney injury; All-cause mortality; Cardiac arrhythmia; Worsening CKD; All-cause hospitalizations; Cardiac arrest; Initiation of dialysis.
Description: Technical Summary
The overall goal of this study is to provide a population-based descriptive analysis of patients receiving RAASi treatment in the UK, with a specific goal of understanding the implications of treatment interruption. RAASi therapy can increase the risk of hyperkalemia, and physicians may decide to reduce the dose or discontinue RAASi therapy following hyperkalemia. The frequency of dose changes and drug discontinuations is not well understood; nor are the subsequent implications in terms of potentially higher event rates. This study will utilize the Clinical Practice Research Datalink (CPRD) database linked to the Hospital Episodes Statistics (HES) database. We will also be requesting ONS Mortality linkage to confirm date of death. The cohort to be studied is patients on RAASi therapy, and we will examine treatment patterns, clinical event rates, factors associated with treatment interruptions, and subsequent events following RAASi treatment interruptions. Event rates and 95% CIs for pre-specified outcomes of interest will be reported. RAASi treatment patterns will be examined using proportion of days covered, interruptions, cessations, and dose changes. A Cox proportional hazards model will be used to examine factors associated with interruption/cessation. Cox models will also be used to examine associations between interruptions/cessations and clinical events of interest.
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Risk of stroke associated with acute exacerbations of chronic obstructive pulmonary disease (COPD): a self-controlled case series — Jennifer Quint ...
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Risk of stroke associated with acute exacerbations of chronic obstructive pulmonary disease (COPD): a self-controlled case series
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-09
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Kieran Rothnie - Corresponding Applicant - GlaxoSmithKline - UK
Olivia Connell - Collaborator - Imperial College LondonOutcomes:
Incident stroke
Description: Technical Summary
We will use CPRD linked with HES and ONS to conduct a self-controlled case series to investigate the risk of stroke in people with COPD during and shortly after periods of exacerbation compared to stable periods. The self-controlled case series method allows the effects of transient exposures on events to be investigated. A major advantage of this method is that fixed confounders are controlled for implicitly such as genetics, gender and socio-economic factors (4). We will investigate whether there is an increased risk of stroke associated with acute exacerbations of COPD (AECOPD) and investigate the length of the period of potential increased risk. We will also investigate whether severity of AECOPD, previous frequency of exacerbations, respiratory drugs, cardiovascular drugs and influenza vaccination modifies any risk of stroke associated with AECOPD. The findings from this study will be used by clinicians to understand when their COPD patients are at highest risk of stroke. The findings may also inform future interventions to reduce this risk.
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Examining congenital malformations, pervasive developmental disorders and spontaneous abortion as potential adverse outcomes of influenza vaccination in pregnancy. — Sara Thomas ...
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Examining congenital malformations, pervasive developmental disorders and spontaneous abortion as potential adverse outcomes of influenza vaccination in pregnancy.
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-09
Organisations:
Sara Thomas - Chief Investigator - Not from an Organisation
Maria Peppa - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health England
Punam Mangtani - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
The 2009/10 influenza pandemic necessitated the production of a monovalent, inactivated H1N1 vaccine (PIIV) which was offered in 2009/10 to all pregnant women regardless of trimester. From 2010/11 onwards, all pregnant women have been offered the seasonal inactivated influenza vaccine (SIIV). This study will first use linked primary and secondary care data and death certificate data to develop diagnostic algorithms for the following outcomes: a) congenital malformations (diagnosed pre- or postnatally), b) pervasive developmental disorders and c) spontaneous abortion.
Using a cohort study design, we will then examine whether there is any association between SIIV administered at any point in pregnancy, or in individual pregnancy trimesters between 2010-2016, and major malformations, pervasive developmental disorders and spontaneous abortion. Secondary outcomes of interest following SIIV receipt in pregnancy will include assessing whether the infants/foetuses of pregnant women are at increased risk of developing major or minor malformations, malformations of particular organ systems (defined by EUROCAT) or spontaneous abortion in the 4 weeks after vaccination. Risks will be examined separately for women who received the 2009/10 PIIV. Finally, we will examine the prevalence of inadvertent vaccination and exposure to teratogenic drugs in order to provide information for the direction of future safety studies.
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Exploring the effects of non-alcoholic fatty liver disease (NAFLD) on non-communicable disease and healthcare utilisation — Harry Hemingway ...
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Exploring the effects of non-alcoholic fatty liver disease (NAFLD) on non-communicable disease and healthcare utilisation
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Constantinos Parisinos - Corresponding Applicant - University College London ( UCL )
Alvina Lai - Collaborator - University College London ( UCL )
Amitava Banerjee - Collaborator - University College London ( UCL )
Anoop Shah - Collaborator - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Emmanouil Tsochatzis - Collaborator - University College London ( UCL )
Hanane Issa - Collaborator - University College London ( UCL )
Jane Elizabeth Carolan - Collaborator - University College London ( UCL )
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Sheng-Chia Chung - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Suvi Harmala - Collaborator - University College London ( UCL )Outcomes:
Primary Outcomes:
1) All-cause mortality
2) Liver related mortality
3) Cardiovascular related mortality
4) Cancer related mortality
5) Disease progression to liver cirrhosis or hepatocellular carcinomaSecondary Outcomes:
1) Incidence rates of cardiovascular disease (stable angina, unstable angina or coronary disease not further specified, heart failure, non-fatal myocardial infarction, peripheral arterial disease, ischaemic stroke, aortic aneurysm, arrhythmia/sudden cardiac death, unheralded coronary death). Cardiovascular phenotype definitions based on the CALIBER data sources are curated on the CALIBER data portal (https://caliberresearch.org/portal).
2) Incidence rates of non HCC malignancies (lung, breast, renal, prostate, pancreas, oesophageal, colorectal)
3) Healthcare utilisation in patients with cirrhosis (phenotypes relating to admissions will be required including varices, hepatic encephalopathy, hepatocellular carcinoma, ascites, spontaneous bacterial peritonitis, liver transplantation, jaundice)Description: Technical Summary
Non-alcoholic fatty liver disease (NAFLD) exists within a syndrome of disturbed metabolism, including increased total body adiposity, insulin resistance, impaired glucose tolerance and dyslipidaemia. NAFLD covers a spectrum of lesions ranging from steatosis to a complex pattern of hepatocellular injury and inflammation (non-alcoholic steatohepatitis [NASH]) in the absence of substantial alcohol intake. NAFLD is associated with an increased risk of mortality, with cardiovascular disease (CVD) being the most common cause; increasingly, NAFLD is also emerging as a risk factor for pre-malignant and malignant disease; the validation of NAFLD as a significant additional risk factor would have direct relevance for primary preventive strategies. We will use linked primary care, hospitalisation, disease registry and mortality data in England, to investigate associations of NAFLD with progression to cirrhosis and hepatocellular cancer, as well as incident cardiovascular disease and malignancies. We will include people aged 18 or older, with no prior liver disease or excess alcohol use. We will use time series analysis to compare incidence of disease between individuals with and without NAFLD/ NASH. Since NAFLD exists within a metabolic syndrome we will also examine the healthcare utilisation of individuals with NASH cirrhosis as an important secondary outcome measure. Our findings may be used to design new screening strategies in individuals at risk of these conditions.
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Estimating the prevalence of hyperkalemia in the UK, in patients with chronic kidney disease and/or heart failure — Mireia Raluy Callado ...
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Estimating the prevalence of hyperkalemia in the UK, in patients with chronic kidney disease and/or heart failure
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-26
Organisations:
Mireia Raluy Callado - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Alex Simpson - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Donaldson - Collaborator - Evidera, Inc
Vrouchou Panagiota - Collaborator - Vifor PharmaOutcomes:
Prevalence of hyperkalemia; Renin-angiotensin aldosterone- system inhibitor treatment patterns.
Description: Technical Summary
Hyperkalemia is medically defined as a blood serum potassium level of > 5.5mmol/L, which can arise from ineffective elimination of potassium from the blood. Hyperkalemia is common in patients with CKD and HF as the kidneys are unable to sufficiently remove excess potassium from the blood. RAAS inhibitors are indicated for the treatment of CKD and HF as they lower resistance in the blood vessels of the kidneys through inhibition of key enzymes controlling the RAAS system. A side effect of this inhibition is the retention of potassium, which may lead to hyperkalemia in high-risk patients, meaning that patients on RAASis may be undertreated. The purpose of this study is to gain an understanding of the prevalence of hyperkalemia among patients with CKD, HF, or both CKD and HF, and to determine clinical decisions after a hyperkalemia event in these groups specifically in relation to treatment with renin-angiotensin-aldosterone system inhibitor (RAASi) therapy. This research will be important in understanding the unmet need in this patient group for a hyperkalemia treatment which safely controls the condition over the long term. Currently, long term hyperkalemia treatment options are limited in the CKD/HF patient population who are also taking RAASis.
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Assessing the internal and external validity of confidence interval calibration in observation studies — Martijn Schuemie ...
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Assessing the internal and external validity of confidence interval calibration in observation studies
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-20
Organisations:
Martijn Schuemie - Chief Investigator - Janssen US
Martijn Schuemie - Corresponding Applicant - Janssen US
Patrick Ryan - Collaborator - Janssen Research & Development LLCOutcomes:
Upper Gastrointestinal bleeding
Description: Technical Summary
This study will include two analyses investigating the risk of upper Gastrointestinal (GI) bleeding during exposure to selective serotonin reuptake inhibitors (SSRIs), intended to replicate the analyses performed by Tata et al.1 as closely as possible. The first analysis is a matched case-control study; the second analysis is a self-controlled case series (SCCS). The same analyses used to create estimates for upper GI bleeding will also be used to produce estimates for a set of 50 negative control outcomes which are not believed to be caused by SSRIs and where the true relative risk is therefore believed to be one. Additional estimates will be generated for 3x50 synthetic positive controls derived from the negative controls. Positive controls will be generated by fitting outcome models for each negative control, and inserting additional outcomes based on the predicted probabilites of patients for the outcomes, thus preserving any observed confounding stucture while increasing the true relative risk to three predefined levels: 1.5, 2, and 4. Based on the estimates for negative and positive controls a model of systematic error will be fitted, and confidence intervals will be calibrated.
This study will use the CPRD in Common Data Model as described elsewhere
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Comparison of real-world patients with focal epilepsy to patients included in the SP0993 clinical trial — Jessica Jalbert ...
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Comparison of real-world patients with focal epilepsy to patients included in the SP0993 clinical trial
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-04-11
Organisations:
Jessica Jalbert - Chief Investigator - Regeneron Pharmaceuticals
Jessica Jalbert - Corresponding Applicant - Regeneron Pharmaceuticals
Aastha Chandak - Collaborator - LA-SER Europe Ltd ( Certara )
Simon Borghs - Collaborator - UCB Pharma SA - UKOutcomes: none known
Description: Technical Summary
This is an exploratory study to assess the generalizability of findings of the SP0993 clinical trial comparing lacosamide with carbamazepine for the treatment of newly diagnosed focal epilepsy. The specific aims of the study are:
1. To compare characteristics of patients enrolled in the SP0993 trial with those of epilepsy patients newly diagnosed with focal epilepsy (i.e. partial-onset seizures, POS) in routine clinical practice in the UK; and
2. To estimate the proportion of newly diagnosed epilepsy patients treated in routine clinical practice that would have been eligible for SP0993 trial enrolment.The study will be undertaken utilizing linked data within the Clinical Practice Research Database and Hospital Episode Statistics database. The study time frame will be 1 April 2011 to the most recent data available. Aim 1 will be evaluated by comparing patient characteristics (age, gender, time since diagnosis, comorbidities, and concomitant medications) between real-world newly diagnosed epilepsy patients treated with lacosamide or carbamazepine and the respective patients from the SP0993 trial. Aim 2 will be assessed by applying each exclusion criteria from the SP0993 trial to the patient population in our study meeting the SP0993 inclusion criteria (i.e. newly diagnosed POS patients initiating lacosamide or carbamazepine). The number and proportion of patients meeting each exclusion criteria as well as the number and percentage of patients remaining after application of all inclusion criteria will be reported.
Source
2017 - 03
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Hypoglycaemia and serious adverse events in older people living with diabetes and dementia â a population-based cohort study — Yoon Loke ...
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Hypoglycaemia and serious adverse events in older people living with diabetes and dementia â a population-based cohort study
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-13
Organisations:
Yoon Loke - Chief Investigator - University of East Anglia
Katharina Mattishent - Corresponding Applicant - University of East Anglia
George Savva - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East AngliaOutcomes:
The primary outcome will be falls and/or fractures. Secondary outcomes will be emergency healthcare and hospitalization, cardiovascular events (acute coronary syndrome, stroke), and overall mortality..
Description: Technical Summary
Background: Treatment of diabetes in older people with dementia is challenging, as clinicians try to achieve a comfortable balance between the pursuit of tight blood sugar control (in accordance with national targets), against pragmatism and avoidance of serious side-effects, such as hypoglycaemia. There is a paucity of evidence regarding risk of hypoglycaemia in patients with diabetes and dementia, and the relationship between hypoglycaemia and serious adverse events (falls or fractures, use of emergency healthcare and hospitalization, heart attacks, and death).
Objectives: To describe serious (medically recorded) hypoglycaemic events in older people with multimorbidity (diabetes and dementia), and to determine risk of associated serious adverse events after serious (medically recorded) hypoglycaemia (falls or fractures, use of emergency healthcare and hospitalization, heart attacks, and death). For ease of reference, all mention of hypoglycaemia is intended to mean serious (medically recorded) hypoglycaemia.
Methods Population-based cohort of patients with diabetes (± dementia) based on CPRD with linkage to Hospital episode statistics, and Office for National Statistics datasets.
Data Analysis Kaplan-Meier survival curves will be used to display the survival curve for each adverse outcome after incident exposure to a hypoglycaemic event. The association between hypoglycaemic exposure and serious subsequent adverse event, will be evaluated using Cox proportional hazard regression models with adjustment for appropriate confounders to estimate a Hazard Ratio and 95% confidence interval.
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Acute exacerbations of chronic obstructive pulmonary disease: Clinical history and effects on rate of recurrent events and risk of death — Jennifer Quint ...
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Acute exacerbations of chronic obstructive pulmonary disease: Clinical history and effects on rate of recurrent events and risk of death
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-28
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Kieran Rothnie - Corresponding Applicant - GlaxoSmithKline - UK
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Rate of exacerbations of COPD - Mortality
Description: Technical Summary
People with chronic obstructive pulmonary disease (COPD) often have acute worsening of their symptoms, termed acute exacerbations of COPD (AECOPD). These may be treated in primary care or may require hospitalisation.
Frequency of AECOPD is thought to be a stable trait over time, however this has not been investigated in a primary care cohort. Although others have studied the relationship between severe AECOPD (hospitalised) and risk of death in those with COPD, this relationship is not clear for moderate AECOPD (treated by GP).
We hypothesise that there are a large portion of COPD patients who never exacerbate, and that long term risk of death increases with increasing number of baseline AECOPD and with AECOPD severity.
Using linked CPRD-HES-ONS data, we will perform a cohort study to investigate the rates of AECOPD (moderate and severe) and death during follow-up by baseline AECOPD frequency (defined as first 12 months after observation start). In particular we will characterise the rate of AECOPD and death in COPD patients who do not seem to exacerbate during baseline period. We will also conduct three nested case-control analyses to investigate the impact of frequency and severity of AECOPD in the previous three years on risk of: 1) moderate AECOPD; 2) severe AECOPD; and 3) death.
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Drug utilisation study of new users of umeclidinium / vilanterol (UMEC/VI) and umeclidinium (UMEC) in the primary care setting — Daniel Dedman ...
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Drug utilisation study of new users of umeclidinium / vilanterol (UMEC/VI) and umeclidinium (UMEC) in the primary care setting
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-01
Organisations:
Daniel Dedman - Chief Investigator - CPRD
Daniel Dedman - Corresponding Applicant - CPRD
Gema Requena - Collaborator - GlaxoSmithKline - UK
Jeanne Pimenta - Collaborator - BioMarin Pharmaceutical Inc.
Rachael Williams - Collaborator - CPRD
Rebecca Ghosh - Collaborator - CPRD
Sonia Coton - Collaborator - CPRDOutcomes: none known
Description: Technical Summary
Umeclidinium/vilanterol (UMEC/VI) and umeclidinium (UMEC) launched in the UK during 2014, along with other long-acting bronchodilator (LABD) medications, are indicated for the treatment of Chronic Obstructive Pulmonary Disease (COPD). This study will describe the patient populations newly prescribed 1) UMEC/VI, 2) UMEC, and 3) other specified LABDs, and determine the frequency of possible off-label use i.e. prescribing in patients without a COPD diagnosis. New users of other LABD comprise a natural comparator group for any future study of the safety and effectiveness of UMEC /VI and UMEC. It is therefore of interest to assess the extent of any baseline differences between new users of UMEC /VI and UMEC, and new users of similar treatments. Incidence of major cardiovascular and cerebrovascular events, pneumonia, COPD exacerbations, and death will be estimated in new users of UMEC/VI and UMEC only. Treatment patterns in the first 12 months following initiation will also be described for UMEC/VI and UMEC. The results will inform feasibility assessment and planning potential future risk-benefit studies.
To ensure adequate numbers of new users of the recently launched UMEC/VI and UMEC, the study will use data from two primary care electronic medical record (EMR) databases: CPRD GOLD; and the THIN database.
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The relationship between non-valvular atrial fibrillation and dementia — Carlos Martinez ...
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The relationship between non-valvular atrial fibrillation and dementia
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-28
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Antonio Curcio - Collaborator - University Magna Graecia
Bob Weijs - Collaborator - Maastricht University
Michela Giustozzi - Collaborator - University of Perugia
Saulius Sudikas - Collaborator - Vilnius City Clinical Hospital
Thalia Field - Collaborator - University Of British ColumbiaOutcomes:
Dementia
Description: Technical Summary
The risk of both dementia and atrial fibrillation (AF) increases with age, and several studies have found an increased risk of dementia in AF patients, although findings are inconsistent. Several mechanisms for this association have been proposed, including potential causative factors such as micro emboli, cerebral microbleeds, variable cerebral perfusion and stroke-related dementia. However it is unclear whether this association exists independently or is related to shared vascular risk factors for AF and dementia. Furthermore, the potential modifying role of anticoagulation in AF - which reduces the risk of stroke by two-thirds - in its relationship with dementia is also unknown. This study will investigate the association between incident non-valvular AF and new-onset dementia in a cohort with incident non-valvular AF and a matched cohort without AF.
Adjusted hazard ratios of the association between non-valvular AF and dementia compared with non-AF will be estimated using Cox regression. Sensitivity analyses will be performed excluding patients with a history of stroke and antidepressant use.
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Nitrates, 5-alpha-reductase inhibitors and hormone replacement therapy and the risk of gastrointestinal cancers. — Chris Cardwell ...
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Nitrates, 5-alpha-reductase inhibitors and hormone replacement therapy and the risk of gastrointestinal cancers.
Datasets:GP data, Chris Cardwell - Chief Investigator - Queen' s University Belfast
Chris Cardwell - Corresponding Applicant - Queen' s University Belfast
Liam Murray - Collaborator - Queen' s University Belfast
Maria Constanza Camargo - Collaborator - National Cancer Institute ( NCI )
Peter Murchie - Collaborator - University of Aberdeen
Shahinaz Gadalla - Collaborator - National Cancer Institute ( NCI )Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-28
Organisations:
Chris Cardwell - Chief Investigator - Queen's University Belfast
Chris Cardwell - Corresponding Applicant - Queen's University Belfast
Liam Murray - Collaborator - Queen's University Belfast
Maria Constanza Camargo - Collaborator - National Cancer Institute ( NCI )
Peter Murchie - Collaborator - University of Aberdeen
Shahinaz Gadalla - Collaborator - National Cancer Institute ( NCI )Outcomes: none known
Description: Technical Summary
Background: Preclinical and epidemiological evidence suggest nitrates could increase gastrointestinal cancer risk and that 5α-reductase inhibitors and HRT could reduce gastrointestinal cancer risk.
Aims: To investigate the associations between nitrates \ 5α-reductase inhibitors \ HRT and gastrointestinal cancer risk.
Methods: A nested case-control study will be conducted within the Clinical Practice Research Datalink (CPRD). In the primary analysis incident gastrointestinal cancer patients will be determined from English cancer registry records (using linkages to the National Cancer Data Repository). The index date in the cases will be their date of cancer diagnosis. Controls will be allocated the index date of their matched case. Exposure to medications will be determined from GP prescription records in the period up to 1 year prior to the index date. Conditional logistic regression will be used to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs). Adjustment for various potential confounders will be conducted. Analyses will be conducted separately by cancer site (oesophageal, gastric and liver).
Potential: The study could determine that nitrate medications are associated with increased gastrointestinal cancer risk; requiring careful risk benefit analysis before use. The study could also identify 5α-reductase inhibitors and HRT as potential chemoprevention agents for these cancers.
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Evaluation of the impact of glucose-lowering treatment with pioglitazone on stroke outcomes — Christopher Morgan ...
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Evaluation of the impact of glucose-lowering treatment with pioglitazone on stroke outcomes
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-28
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Incident stroke - Morbidity due to stroke - Stroke recurrence - Mortality due to stroke
Description: Technical Summary
The aim of the study is to compare stroke outcomes for patients with diabetes treated with either pioglitazone or non-pioglitazone inclusive regimens. Patients treated with pioglitazone will be selected from the Clinical Practice Research Datalink and matched to controls by demographic, treatment and morbidity criteria. HES inpatient, outpatient and ONS data will be required for this study, so the population will be limited to English patients participating in the linkage scheme. Time to incident stroke event and subsequent events will be compared using Cox proportional hazards models. The proportion of patients treated with and without pioglitazone and those previously treated with pioglitazone but subsequently discontinued who have a stroke event and die within 28 days following an index event and the proportion of patients that require hospitalised rehabilitation will be compared by logistic regression. Linear regression will be used to compare length of stay relating to stroke events.
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Ovulation-Inducing Fertility Treatments and the Long-Term Risk of Breast Cancer — Samy Suissa ...
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Ovulation-Inducing Fertility Treatments and the Long-Term Risk of Breast Cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-26
Organisations:
Samy Suissa - Chief Investigator - McGill University
Haim Abenhaim - Corresponding Applicant - McGill University
Togas Tulandi - Collaborator - McGill UniversityOutcomes:
Breast cancer.
Description: Technical Summary
Background: Fertility treatments whose mechanisms of action involve the induction of ovulation cause circulating levels of estrogen and progesterone to increase to supraphysiologic levels which may contribute to long-term risk of breast cancer due to the cancer's strong interplay with a woman's hormonal profile. Objectives: To examine the association between three different fertility treatments which aid in inducing ovulation and breast cancer risk. Methods: A population-based matched case control study using the CPRD will be performed to calculate odds ratios for the treatments of interest: clomiphene, letrozole and in-vitro fertilization. Incident cases of breast cancer will be ascertained through a validated algorithm used in prior breast cancer studies by our group using the same database. Controls will be population-based. Exposure will be assessed through the patient's medical history for evidence of being prescribed/having undergone one of the three aforementioned fertility treatments. Data Analysis: Conditional logistic regression will be used to calculate odds ratios and 95% CIs comparing the exposure of these three fertility treatments in breast cancer cases compared to the exposure levels in controls. Some confounding factors, notably age, calendar time of follow-up and socioeconomic status will be adjusted for through matching, while the remaining factors will be adjusted for through the logistic regression.
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Short term High Density Lipoprotein cholesterol decrease and cardiovascular risk — Julia DiBello ...
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Short term High Density Lipoprotein cholesterol decrease and cardiovascular risk
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-29
Organisations:
Julia DiBello - Chief Investigator - Merck & Co., Inc.
Julia DiBello - Corresponding Applicant - Merck & Co., Inc.
J. Bradley Layton - Collaborator - RTI Health Solutions
Til Stürmer - Collaborator - University of North Carolina at Chapel HillOutcomes:
Primary outcome: major adverse cardiovascular events (myocardial infarction, revascularization, ischemic stroke, cardiovascular related death)
Description: Technical Summary
High density lipoprotein cholesterol (HDL-C) has many biologically protective effects. HDL-C is thought to remove excess cholesterol from cells, transport it to the liver for excretion, to maintain cholesterol homeostasis in the body, and may also slow atherosclerosis through antioxidant and anti-inflammatory activity. Statin medications are commonly used for primary and secondary prevention of cardiovascular (CV) events. While these medications decrease low density lipoprotein cholesterol, they have also been shown to decrease HDL-C in some patients, and this decrease in HDL-C has been associated with increased risk of CV events. This retrospective cohort study in statin initiators using statins for 6 months or less will generate additional evidence surrounding the association between decreases in HDL-C and risk of subsequent CV events. Subjects with a decrease in HDL-C post statin initiation will be compared to those with constant HDL-C for the occurrence of subsequent CV events. Propensity score weighting will be used to adjust for confounding and log binomial and Cox proportional hazards regression will be used to estimate risk differences and hazard ratios, respectively.
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Burden of disease in patients with COPD and high blood eosinophil counts — David Price ...
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Burden of disease in patients with COPD and high blood eosinophil counts
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-01
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Chin Kook Rhee - Collaborator - Seoul St. Mary's Hospital The Catholic University of Korea
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Gopalan Gokul - Collaborator - Astra Zeneca Inc - USA
Ian Pavord - Collaborator - University of Oxford
Marc Miravitlles - Collaborator - Hospital Universitari Vall d'Hebron
Rupert Jones - Collaborator - Plymouth University
Sadia Halim - Collaborator - Astra Zeneca Inc - USA
Sarang Rastogi - Collaborator - Astra Zeneca Inc - USAOutcomes:
COPD exacerbations; Hospital admissions as the index date (first admission) in HES linked data; Occurrence of a hospital admission (spell) for COPD exacerbation in HES linked data: 1 of the following ICD-10-CM codes in any diagnostic position: - J44.0: Chronic obstructive pulmonary disease with acute lower respiratory infection; - J44.1: Chronic obstructive pulmonary disease with (acute) exacerbation Hospital re-admission as outcome event; COPD exacerbations in any diagnostic position b. ICD-10 codes J40-J44; Any COPD-related code as primary diagnosis Mortality; All-cause mortality; Health care Resource Use (HRU): The following outcomes of HRU are described in the baseline year and outcome year in patients with HES data available. 1. Physician office visits 2. Outpatient visits 3. Accident & Emergency (A&E) attendances / out of hours services 4. Hospital admissions 5. Number of COPD-related drug prescriptions
Description: Technical Summary
Objectives: 1. To study whether patients admitted to hospital for COPD exacerbation are more likely to be re-admitted if their pre-admission blood eosinophil counts (BEC) is high 2. To compare COPD-related health care resource use (HRU) and costs of patients who are at risk of exacerbations while on triple therapy, with that of average COPD patients 3. To study whether high BEC are associated with greater costs and explore other accessible factors that may drive costs Methods: Patients will be characterised in a baseline year prior to index date (ID). Objective 1: The risk of COPD-related re-admission to hospital within 4 and 52 weeks after ID will be compared for patients with and without high eosinophil counts. ID is date of most recent first discharge from hospital for COPD exacerbation, occurring within one year after a blood eosinophil count measurement at a time of no recent exacerbation. Objectives 2/3: HRU and costs- total, and broken down by type of utilisation - will be estimated, stratified by smoking status, in a follow-up year after ID. ID is date of most recent eosinophil count recorded at the time of no recent exacerbation. A model will be developed to predict future costs.
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Are primary care consultations about insomnia associated with later dementia? — Elizabeth Ford ...
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Are primary care consultations about insomnia associated with later dementia?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-26
Organisations:
Elizabeth Ford - Chief Investigator - Brighton and Sussex Medical School
Richard Hoile - Corresponding Applicant - Sussex Partnership NHS Foundation Trust
Helen Smith - Collaborator - Nanyang Technological University
Jackie Cassell - Collaborator - Brighton and Sussex Medical School
Naji Tabet - Collaborator - Brighton and Sussex Medical School
Philip Rooney - Collaborator - University of Sussex
Stephen Bremner - Collaborator - Brighton and Sussex Medical SchoolOutcomes:
Dementia diagnosis.
Description: Technical Summary
We propose a 1:1 matched case-control study, using 8414 anonymised GP records already acquired for our main study (ISAC Protocol 15_111R). The study aims to explore the association between insomnia and later dementia. Insomnia consultations will be identified using relevant Read codes. Our measure of insomnia will be the the number of months in which the patient consulted the GP about insomnia, during the period 5-10 years before the index date (defined for cases as the first coded diagnosis of dementia). This 5-10 year exposure window will help address the problem of 'reverse causality', whereby we might record insomnia episodes which are merely an early symptom of dementia, rather than a risk factor for later disease. We will use conditional logistical regression to estimate the odds ratio (OR) of developing dementia in those exposed compared to those not exposed, and to control for covariates including benzodiazepine and z-drug use, mental and physical health comorbidities, and GP visit frequency.
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Exploration of long term cardiovascular outcomes following pregnancy complicated by hypertensive disorders or pregnancy — Ruth Gilbert ...
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Exploration of long term cardiovascular outcomes following pregnancy complicated by hypertensive disorders or pregnancy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-08
Organisations:
Ruth Gilbert - Chief Investigator - University College London ( UCL )
Ruth Gilbert - Corresponding Applicant - University College London ( UCL )
Aisha Gohar - Collaborator - University Medical Centre Utrecht
Alicia Uijl - Collaborator - Utrecht University
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Fergus McCarthy - Collaborator - University College Cork
Folkert Asselbergs - Collaborator - University College London ( UCL )
Lucy Chappell - Collaborator - King's College London (KCL)
Lydia Leon - Collaborator - University College London ( UCL )
Pia Hardelid - Collaborator - University College London ( UCL )
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Spiros Denaxas - Collaborator - University College London ( UCL )
Stefan Koudstaal - Collaborator - University College London ( UCL )Outcomes:
Transient ischaemic attacks; All sub-types of stroke; Hypertension; Stable angina; Unstable angina; Myocardial infarction; Peripheral vascular disease; Heart failure and its sub-phenotypes; Venous thromboembolism; Atrial fibrillation; Ventricular arrhythmia; Vascular dementia.
Description: Technical Summary
Cardiovascular disease (CVD) remains the leading cause of mortality in women in the United Kingdom. Pre-eclampsia is a disease of placental aetiology and is characterised by hypertension and proteinuria. Hypertensive disorders of pregnancy are a term used to classify hypertensive complications occurring during pregnancy and may be divided into 1. Chronic hypertension 2. Gestational hypertension 3. Pre-eclampsia de novo or superimposed on chronic hypertension and 4. White coat hypertension. 1-3 We hypothesise that women whose pregnancies are complicated by hypertensive disorders of pregnancy are at long term increased risk of cardiovascular disorders, but the magnitude of the association will vary by CVD disorders and certain characteristics of the women. This study aims to estimate the association of differing phenotypes of pre-eclampsia and other hypertensive disorders of pregnancy with a full spectrum of cardiovascular disorders of relevance to the current British population. We will conduct a cohort study and use risk ratios to estimate binary outcomes. For continuous measures, transformations that approximate to the normal distribution, will be used as appropriate, and multivariate cox proportional hazard models (adjusting for key confounders) will be used to estimate the hazard ratio of the exposures on the outcomes of interest.
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Matched population-based cohort study determining the incidence and risk of cardiovascular outcomes for patients with familial hypercholesterolaemia — Stephen Weng ...
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Matched population-based cohort study determining the incidence and risk of cardiovascular outcomes for patients with familial hypercholesterolaemia
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-10
Organisations:
Stephen Weng - Chief Investigator - University of Nottingham
Stephen Weng - Corresponding Applicant - University of Nottingham
Barbara Iyen - Collaborator - University of Nottingham
Beth Woods - Collaborator - University of York
Jo Leonardi-Bee - Collaborator - University of Nottingham
Nadeem Qureshi - Collaborator - University of Nottingham
paul roderick - Collaborator - University of SouthamptonOutcomes: none known
Description: Technical Summary
Background: Untreated heterozygous familial hypercholesterolaemia dramatically increases risk of coronary heart disease. There is currently limited evidence on whether FH is also associated with stroke (CVA), and other non-CHD/non-CVA cardiovascular diseases.
Objectives: The aim of this study is to determine the incidence and risk of all cardiovascular outcomes for patients with familial hypercholesterolaemia compared to patients without FH.
Study Design: Matched cohort study
Setting: UK General Practice
Participants: All patients with a recorded cholesterol (LDL or TC), without history of CVD at baseline, registered with general practice for at least one year before study entry
Exposures: (i) Definite FH â Those diagnosed with FH identified by Read Code for definitive âfamilial hypercholesterolaemiaâ (ii) Likely FH â No definitive diagnosis but meet established clinical criteria
Comparator: Non-FH general population with LDL or TC recorded (+/- 6 months) at the time of diagnosis of FH in the exposed group: matched (by age, gender, general practice at baseline) one exposed patient (definite FH or likely FH) to at least 3 unexposed non-FH patients
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The risk of fractures in new users of statins: A propensity-score matched sequential cohort study — Christoph Meier ...
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The risk of fractures in new users of statins: A propensity-score matched sequential cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-10
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Julia Spoendlin - Corresponding Applicant - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Theresa Burkard - Collaborator - University of BaselOutcomes:
We will investigate a composite outcome including all first-time ever fragility fractures, i.e. - Malleolus (ankle), foot - femur, hip - vertebrae - humerus, shoulder, lower arm, wrist, hand - undefined Patients will be followed until the first fracture code after cohort entry is observed.
Description: Technical Summary
There has been an ongoing scientific discussion over the past two decades, about whether or not statins reduce the risk of fragility fractures. This discussion was triggered by results from observational studies, one of which was a CPRD-based nested case-control analysis from our group, in which we reported a 45% decreased relative risk of fractures in statin users. More recent studies, including some randomized clinical trials, did not reproduce this finding and reported a null-association. We therefore aim to re-assess the relative risk of fracture associated with new statin use (a prior 3 years statin-free history is required), using CPRD data in a propensity score (PS)-matched sequential cohort study. Statin initiators will be matched to non-initiators on their PS within 2 year entry blocks (to avoid time trend bias). We will follow all patients from the day of a first statin prescription for 5 years, or until they have a recorded fracture, change of exposure status, or until they are otherwise censored. We will perform subgroup analyses by sex, age, daily statin dose, and by duration of follow-up. Cox proportional hazard analyses will be performed to calculate hazard ratios (HR) with 95% confidence intervals (CI).
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Accounting for multimorbidity, competing risk and direct treatment disutility in risk prediction tools for the primary prevention of cardiovascular disease and fracture. — Bruce Guthrie ...
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Accounting for multimorbidity, competing risk and direct treatment disutility in risk prediction tools for the primary prevention of cardiovascular disease and fracture.
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Townsend Score; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-12
Organisations:
Bruce Guthrie - Chief Investigator - University of Edinburgh
Daniel Morales - Corresponding Applicant - University of Dundee
Peter Donnan - Collaborator - University of Dundee
Shona Livingstone - Collaborator - University of DundeeOutcomes:
#NAME?
Description: Technical Summary
Clinical guidelines recommend that patients with a cardiovascular risk of greater than 10% are treated with statins to prevent cardiovascular events. However, existing risk-prediction models may not account for the impact of multimorbidity and may be inaccurate in such patients. The aim of this study is to determine the accuracy of existing risk prediction models for cardiovascular disease (CVD) in people with multimorbidity. Existing risk prediction algorithms will be replicated in a cohort of adults without CVD using data on established risk factors. This cohort will then be used to derive and validate new risk prediction models accounting for competing risk in people with multimorbidity using a competing risk Cox proportional hazards regression model based on the method of Fine and Gray to estimate the associations between risk factors and outcomes. Discrimination will be examined using the area under the receiver operator characteristic curve by comparing the predicted CVD event rates from the model with observed rates for subsets of people with multimorbidity expected to have high competing risks of non-CVD death. The performance of these models will then be compared to existing models.
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Drug utilization study of mirabegron (Betmiga) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland — Helen Booth ...
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Drug utilization study of mirabegron (Betmiga) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-30
Organisations:
Helen Booth - Chief Investigator - CPRD
Helen Booth - Corresponding Applicant - CPRD
Daniel Dedman - Collaborator - CPRDOutcomes:
Proportion of mirabegron initiators with hypertension; Frequency of blood pressure recording in mirabegron initiators.
Description: Technical Summary
The aim of this study is to determine the effectiveness of a 'Dear Doctor' communication highlighting a contraindication in use of mirabegron in patients with severe and uncontrolled hypertension. The objectives are to determine the proportion of patients newly-prescribed mirabegron who have documented hypertension (controlled, uncontrolled and severe uncontrolled), and to evaluate the frequency of blood pressure recording in mirabegron patients stratified by their hypertension status at the index date. A retrospective cohort design will be used, selecting patients initiating mirabegron treatment between 20th December 2012 and 31st December 2016. Patient time will be divided into periods of uninterrupted mirabegron use, and descriptive results will be presented pre- and post- dissemination of the 'Dear Doctor' letter. If adequate patient numbers are available, an interrupted time series design will be utilised to estimate incremental changes in hypertension status among mirabegron users in relation to time after the 'Dear Doctor' letter.
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Canagliflozin in patients with type 2 diabetes: understanding the real world evidence: CAPTURE study 'Capture - treatment patterns in EMEA' — Pamela Gillian Hamilton ...
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Canagliflozin in patients with type 2 diabetes: understanding the real world evidence: CAPTURE study 'Capture - treatment patterns in EMEA'
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-06
Organisations:
Pamela Gillian Hamilton - Chief Investigator - Janssen France
Pamela Gillian Hamilton - Corresponding Applicant - Janssen France
Joris Diels - Collaborator - Janssen Pharmaceutica NVOutcomes:
Canagliflozin will be descriptively compared with the following antidiabetic treatments: - Sulphonylureas: glimepiride, glibenclamide and gliclazide. - DPP4: sitagliptin, saxagliptin, vildagliptin, linagliptin and alogliptin. - GLP1: exenatide (immediate release: Byetta; depot: Bydureon), liraglutide and lixisenatide - TZD: pioglitazone - SGLT2: dapagliflozin and empagliflozin; - Insulin
Description: Technical Summary
This study will describe the characteristics and pattern of treatment of patients with T2DM initiated on canagliflozin compared with alternative treatment options, using the CPRD data base The study population will consist of adult T2DM patients, initiated on antidiabetic treatment and describe the treatment patterns during the study period of the most recent 5-year period available in the database at the time of the first analysis. Patient profiles at initiation and treatment patterns for canagliflozin will be compared descriptively with other antidiabetic treatments. In order to determine antidiabetic treatment patterns, prescriptions of the antidiabetic drugs will be converted into episodes of uninterrupted use. After constructing the treatment episodes of antidiabetic treatments, sequential changes will be determined, resulting in a treatment pattern. Adherence will be determined using the medication possession ratio (MPR), calculated as the number of days supplied or prescribed divided by the duration of the exposure period. The time to the first initiation of insulin/GLP1 will be estimated using a Kaplan Meier survival analysis. Comparative analyses will be conducted on the time to event endpoints Adjusted HR will be estimated, based on multivariate Cox proportional hazards models, adjusting for potential confounding related to differences in characteristics between patient cohorts.
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The diagnostic utility of inflammatory markers in primary care: a prospective cohort study. — Jessica Watson ...
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The diagnostic utility of inflammatory markers in primary care: a prospective cohort study.
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-13
Organisations:
Jessica Watson - Chief Investigator - University of Bristol
Jessica Watson - Corresponding Applicant - University of Bristol
Chris Salisbury - Collaborator - University of Bristol
Hayley Jones - Collaborator - University of Bristol
Penny Whiting - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of Bristol
William Hamilton - Collaborator - University of Exeter
Yvette Pyne - Collaborator - University of BristolOutcomes:
Incidence of cancer - Number of consultations - Number of antibiotic prescriptions - Incidence of infections - Number of blood tests - Incidence of autoimmune conditions - Number of referrals
Description: Technical Summary
Millions of inflammatory marker tests (C reactive protein, plasma viscosity and eosinophil sedimentation rate) are performed in the UK annually and testing rates are rising. Most studies of inflammatory markers describe laboratory findings for one single disease, usually in secondary care. The spectrum of diseases seen with abnormal results in primary care is not known, making interpretation of results challenging for GPs.
This study aims to identify the conditions diagnosed subsequent to an inflammatory marker blood test in primary care. We will study 80,000 patients with inflammatory marker tests in 2014; and 20,000 matched patients with no inflammatory markers. We will measure the subsequent incidence of cancer, infection and autoimmune diseases in the test normal and test positive groups in order to calculate positive and negative predictive values for infections, autoimmune conditions and cancers. We will plot diagnostic accuracy at different levels of raised inflammatory marker using receiver operator curve analysis of sensitivity against 1-specificity, to explore optimum thresholds. We compare incidence of disease in the tested versus untested groups to calculate the diagnostic accuracy of the clinician's decision to request inflammatory markers. The findings will help clinicians receiving test results make informed decisions about appropriate further investigations or reassurance.
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Stratified 30 day excess risks of emergency hospital admissions and death following gastrointestinal endoscopy — Colin Crooks ...
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Stratified 30 day excess risks of emergency hospital admissions and death following gastrointestinal endoscopy
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-05
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Colin Crooks - Corresponding Applicant - University of NottinghamOutcomes:
Emergency Hospital admission within 30 days; All-cause mortality within 30 days.
Description: Technical Summary
We will measure excess 30 day absolute risks of emergency hospital admission or death following gastrointestinal endoscopy. These risks will be stratified by type of event, age, sex, socioeconomic status, whether the procedure was planned or an emergency, whether a therapy was performed, and by pre-existing co-morbidity using the Charlson index and bespoke co-morbidity score derived from the CPRD. Events due to diagnoses that might have been related to the indication for the endoscopy will be censored, and will be included in the models as a competing risk using cumulative incidence functions. In addition, further procedures will also be censored. The excess risk associated with each procedure will be calculated by the difference between the risks from the endoscopy cohort with those in an age and sex frequency matched population comparison cohort. We will also perform two secondary analyses to assess the excess risk over an extended 60-days post procedure to identify the time period when any excess risk occurs and whether this returns to the baseline in the comparison cohort by 30 days. Finally, we will assess changes in risks with a test for trend over the calendar years of the study.
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Primary and secondary healthcare contacts in children born preterm and their households — Katie Harron ...
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Primary and secondary healthcare contacts in children born preterm and their households
Datasets:GP data, CPRD Mother-Baby Link; CPRD Mother-Baby Link; HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-28
Organisations:
Katie Harron - Chief Investigator - University College London ( UCL )
Katie Harron - Corresponding Applicant - University College London ( UCL )
Caroline Minassian - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
David Cromwell - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jan van der Meulen - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Maria-Luisa Pettigrew - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ruth Gilbert - Collaborator - University College London ( UCL )
Sara Thomas - Collaborator - Not from an OrganisationOutcomes:
⢠Primary care consultations ⢠Unplanned inpatient admissions ⢠A&E visits
Description: Technical Summary
We aim to describe the interaction between primary and secondary healthcare service use in children aged 1-10 years who were born preterm (<37 weeks gestation), and to explore individual and household determinants of emergency hospital use, by using 1) linkage with HES inpatient and A&E data; 2) the pregnancy register; and 3) the household indicator.
Firstly, we will describe patterns of health service use (number of regularity of primary and secondary care contacts) in children born preterm with different childhood chronic conditions. Secondly, we will use the CPRD household indicator to define household characteristics, e.g. number of siblings, number of adults, and health burden (total healthcare contacts per person-year). To identify determinants of variation in emergency healthcare use, we will model the number of emergency hospital admissions per child-year, evaluating the effects of primary care contacts, individual risk-factors, and household characteristics.
This study will help identify vulnerable households who may be at risk of unnecessary hospital contacts and who would most benefit from increased support in the community. This evidence will help policy makers and commissioners make informed decisions about the best ways to meet the needs of these families through maternity and paediatric services.
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Domestic violence and abuse and prescription of emergency contraception: a nested case-control study in CPRD — Natalia Lewis ...
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Domestic violence and abuse and prescription of emergency contraception: a nested case-control study in CPRD
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-01
Organisations:
Natalia Lewis - Chief Investigator - University of Bristol
Natalia Lewis - Corresponding Applicant - University of Bristol
gene feder - Collaborator - University of Bristol
John Macleod - Collaborator - University of Bristol
Joni Jackson - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of BristolOutcomes:
Prescription of emergency contraception; Frequency of prescription of emergency contraception.
Description: Technical Summary
Domestic violence and abuse (DVA) is a public health and clinical problem which adversely affects women's health. IRIS is a national training, support and referral programme for GPs built upon clinical enquiry among patients with signs and symptoms of DVA (case-finding). A recent Domestic Homicide Review and rapid literature review have suggested that request for emergency contraception may be a new indicator of woman's exposure to DVA. However, such limited evidence is not sufficient to amend the existing IRIS training. It is therefore important to obtain evidence from the UK population. Currently, community pharmacies, general practices and community reproductive health clinics are the main sources of emergency contraception in the UK. Up to a third of all emergency contraceptive pills are prescribed by GPs. We propose to use the Clinical Practice Research Datalink to examine the association between prescription(s) of emergency contraception and preceding exposure to DVA. If we identify that those women who are prescribed emergency contraception are more likely to be exposed to DVA than those who do not have the prescription, we will add the new evidence to the IRIS training and extend it to all core providers of emergency contraception.
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Statin prescribing and depression after incident stroke — Duncan Edwards ...
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Statin prescribing and depression after incident stroke
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-08
Organisations:
Duncan Edwards - Chief Investigator - University of Cambridge
Zhirong Yang - Corresponding Applicant - University of Cambridge
James Brimicombe - Collaborator - University of Cambridge
Jonathan Mant - Collaborator - University of Cambridge
Lucy Gerza - Collaborator - University of CambridgeOutcomes:
First-stroke - Post-stroke statins use - Post-stroke depression
Description: Technical Summary
Stroke has many long-term consequences which are managed within primary care. This study intends to describe healthcare for stroke survivors within primary care in the United Kingdom (UK) whose incident stroke occurred between 2000 and 2014. Trends in incidence of stroke, statin prescribing and incident depression after stroke will be described. This retrospective cohort study method will include patients registered with a General Practitioner (GP) within the Clinical Research Practice Datalink (CPRD) and having a first stroke recorded as occurring between 1st January 2000 and 31st December 2014. The key outcomes of interest are incidence of stroke, statin prescribing and incident depression. Analyses will be descriptive for incidence of first stroke over time, and incidence of post- stroke depression. Statistical regression analyses will be performed to model effects of covariates on statin prescription and depression outcomes.
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Management of patients with Non-Valvular Atrial Fibrillation following a first clinically relevant bleed whilst being treated with an Oral Anticoagulant English clinical practice: a cohort study based on CPRD-Hospital Episode Statistics data — Sreeram Ramagopalan ...
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Management of patients with Non-Valvular Atrial Fibrillation following a first clinically relevant bleed whilst being treated with an Oral Anticoagulant English clinical practice: a cohort study based on CPRD-Hospital Episode Statistics data
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-28
Organisations:
Sreeram Ramagopalan - Chief Investigator - London School Of Economics & Political Science
Cormac Sammon - Corresponding Applicant - PHMR Associates
Alexander Cohen - Collaborator - King's College London (KCL)
Caritey Benoît-Damien - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Cinira Lefevre - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Donna Fountain - Collaborator - PHMR Associates
Gillian Stynes - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Matthew Lumley - Collaborator - Pfizer Ltd - UK
Mihail Samnaliev - Collaborator - PHMR Associates
Nathan Hill - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Sharada Weir - Collaborator - Maverex LtdOutcomes:
Clinically relevant bleeding ⢠Death ⢠Stroke ⢠Thromboembolic events
Description: Technical Summary
The objective of this study is to generate evidence on drug utilisation choices for individuals with NVAF following a first clinically relevant bleed while on an oral anticoagulant (OAC), and to determine the association between therapeutic choices and subsequent adverse patient outcomes. The study will use a retrospective cohort design and utilise CPRD and linked HES data. The population will be stratified according to the availability of novel oral anticoagulants (NOACs) in England and, in the period during which NOACs are available, in terms of the specific OAC used at the time of the first bleed. In each of the stratified populations, drug utilisation in the 6 months following the first bleed will be described in terms of restarting, switching and discontinuing treatment. In the period prior to NOAC availability, the association between patient characteristics and different drug utilisation choices will be explored using multivariate logistic regression and the association between drug utilisation following the first bleed and adverse patient outcomes (bleeding, stroke, thromboembolic events, death) will be explored using Cox regression, adjusting for differences in underlying patient characteristics.
Source -
Pattern of use of Direct Oral AntiCoagulant (DOAC) in Non-Valvular Atrial Fibrillation (NVAF) patients in UK general practices — Gunnar Brobert ...
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Pattern of use of Direct Oral AntiCoagulant (DOAC) in Non-Valvular Atrial Fibrillation (NVAF) patients in UK general practices
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-08
Organisations:
Gunnar Brobert - Chief Investigator - Bayer AG
Gunnar Brobert - Corresponding Applicant - Bayer AG
Ana Ruigomez - Collaborator - CEIFE
Kiliana Suzart-Woischnik - Collaborator - Bayer AG
Luis Alberto Garcia Rodriguez - Collaborator - CEIFE
Luke Roberts - Collaborator - Bayer AG
Martin Homering - Collaborator - Bayer AG
Montse Soriano Gabarro - Collaborator - Bayer AG
Pareen Vora - Collaborator - Bayer AG
Yanina Lenz - Collaborator - Bayer AGOutcomes:
Primary outcomes: 1. baseline characteristics of NVAF patients in the UK prescribed any of the three direct oral anticoagulants (DOACs) (rivaroxaban, dabigatran and apixaban) for the first time for stroke prevention 2. daily dose, dose posology, naive status, treatment duration of DOACs for stroke prevention in NVAF patients including those with renal impairment Secondary outcomes: 1. time-trends in the characteristics of first-time use of DOACs in NVAF patients
Description: Technical Summary
Background
There is a limited data on prescription and usage patterns of direct oral anticoagulants (DOACs) (rivaroxaban, dabigatran, apixaban) in routine care for stroke prevention in non-valvular atrial fibrillation (NVAF). Monitoring the usage patterns of DOACs is essential to study compliance with labelling information.
Objectives
This population-based descriptive study will characterize first-time users of three DOACs in NVAF patients for stroke prevention including those renal impaired. Additionally, it will assess patterns of drug utilization in routine general practice in the UK.
Methods
This is a retrospective cohort study designed to assess the characteristics of patients and patterns of drug utilization in new users of DOACs in the UK by merging the Clinical Practice Research Datalink (CPRD) and The Health Improvement Network (THIN). The enrollment period extends from January 2011 up to last available database extraction.
All patients 18+ years of age with first prescription of DOAC during the study period and diagnosed with NVAF (any time prior index date or within the 2 weeks after the index date).
Data Analysis
Following variables will be analysed: age, gender, co-medications, comorbidities, risk scores, lifestyle factors, healthcare utilization, dose, posology, duration of study drugs. Descriptive statistics will be applied including frequencies and percentages, means (+/-standard deviations), proportions, medians (quartiles) as well as minimum and maximum values.
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Oral anticoagulants for atrial fibrillation and the risk of acute kidney injury — Samy Suissa ...
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Oral anticoagulants for atrial fibrillation and the risk of acute kidney injury
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-03-26
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Adi Klil-Drori - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Rui Nie - Collaborator - McGill University
Sharon Nessim - Collaborator - McGill UniversityOutcomes: none known
Description: Technical Summary
The objective of this study is to examine the risk of acute kidney injury (AKI) with the use of oral anticoagulants in patients with atrial fibrillation (AFib). We will assemble a cohort of patients newly-diagnosed with AFib between 1998 and 2015 using the Clinical Practice Research Datalink (CPRD) with linkage to the Hospital Episode Statistics (HES), and the Office for National Statistics (ONS). Cohort entry will be defined by the first-ever diagnosis of AFib in the CPRD. Primary exposure will be defined in a time-dependent fashion as current use of vitamin K antagonists (VKA) or direct oral anticoagulants (DOACs), separately, and the reference group will be no current use of either. The primary outcome will be the first hospitalization with a diagnosis of AKI. Time-dependent Cox models will be used to estimate the hazard ratio for the association between current use of VKA or DOAC and AKI, compared with no use of either. This outcome will be assessed separately in patients with and without chronic kidney disease (CKD) at cohort entry. Secondary analyses will include duration-response analyses and a comparison of AKI risk with the initiation of VKA and DOACs.
Source
2017 - 02
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Non-specific effects of vaccination in England — Helen McDonald ...
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Non-specific effects of vaccination in England
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Helen McDonald - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anthony Scott - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Miller - Collaborator - Health Protection Agency - HPA
Heather Whitaker - Collaborator - Public Health England
Julia Stowe - Collaborator - Public Health England
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health EnglandOutcomes:
We will examine a range of infection groups, recorded in either CPRD or in HES. These will include upper and lower respiratory tract infections, urinary tract infections, acute gastroenteritis, joint and bone infections, skin infections, neurological infections, eye infections, other bacterial and viral infections, and sepsis. These will be defined using Read and ICD10 code lists, updating the existing code lists we have used in previous ISAC approved studies of infections (for example, ISAC protocols 09-061RA, 11_033A, 15_146). The primary outcome will be any infection; we will then look at individual infection groups (study power permitting).
Description: Technical Summary
This project will investigate aspects of 'non-specific effects' of vaccination; the hypothesised associations between live vaccines and a reduction in the number of infections, and between inactivated vaccines and an increase in the number of infections. Investigations will, in part, take advantage of change in vaccine schedules over time, and thus changes in the order in which live and inactivated vaccines are given. We will use the self-controlled case series method to compare the within-person relative incidence of a range of infections after receipt of inactivated vaccines compared to incidence after live vaccines. First, among infants given BCG (live) vaccine shortly after birth, we will investigate the relative incidence of infections in the first year of life, comparing incidence before and after receipt of the primary schedule of inactivated vaccines. Second, we will analyse the relative incidence of infections in the second year of life before and after receipt of MMR (live) vaccine, and we will compare whether this effect varies between two time periods; up to August 2006 when only MMR vaccine was given, and September 2006 onwards when MMR (live), pneumococcal conjugate vaccine (inactivated) and Meningitis C/Hib (inactivated) vaccines were given at the same time.
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A study on the epidemiology of treated glaucoma in the United Kingdom — Christoph Meier ...
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A study on the epidemiology of treated glaucoma in the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-20
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Luis Velez-Nandayapa - Corresponding Applicant - University of Basel
Claudia Becker - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Glaucoma.
Description: Technical Summary
Glaucoma is a group of progressive optic neuropathies that have in common a slow progressive neurodegeneration of retinal cells and their axons and a concomitant pattern of visual loss. The biological basis of the disease is not yet fully understood, and the factors contributing to its progression are not yet fully characterised. However, intraocular pressure is the only proven treatable risk factor. Glaucoma is the second most common cause of vision loss worldwide behind cataracts, but, unlike cataracts, the vision loss associated with glaucoma is largely irreversible. Among the major types of glaucoma are open-angle (OAG), angle-closure (ACG), secondary glaucoma, and glaucoma with onset in infancy. In 2010 it was estimated that 60.5 million people suffer with OAG or ACG worldwide. These numbers are expected to reach 79.6 million by 2020, and of these, 74% will have OAG. To our knowledge, incidence rates of glaucoma have not been quantified in the UK. We therefore aim to quantify, through an observational study, the incidence rates of diagnosed and treated glaucoma in the U.K. and compare demographic characteristics, comorbidities (e.g. obesity, diabetes, others), and lifestyle factors (smoking, alcohol consumption) between patients with glaucoma and glaucoma-free controls. We will use a case-control design and perform conditional logistic regression using SAS statistical software.
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Investigating the impact of BMI of patient with type 2 diabetes on length and cost of hospital stay for complications related to diabetes. — Marc Evans ...
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Investigating the impact of BMI of patient with type 2 diabetes on length and cost of hospital stay for complications related to diabetes.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-01
Organisations:
Marc Evans - Chief Investigator - Llandough Hospital
Marc Andersen - Corresponding Applicant - Statgroup Ap S - Denmark
Anne Helene Olsen - Collaborator - Novo Nordisk
Arne Haahr Andreasen - Collaborator - Statgroup Ap S - Denmark
Emil Nortoft - Collaborator - Statgroup Ap S - Denmark
Johanne Spanggaard Piltoft - Collaborator - Novo Nordisk
Lars Wilkinson - Collaborator - Novo Nordisk
Uffe Jon Plough - Collaborator - Novo NordiskOutcomes:
For each hospitalisation (each spell) we will derive the outcomes LoS and CoS. CoS will be derived using the NHS HRG Grouper Software and the NHS reference cost list. We will identify diabetes complications and categories based on the diagnosis and/or procedure (ICD-10 code for the primary and secondary diagnosis and/or the OPDC 4.7 code). The diabetes complications categories are Severe hypoglycaemia, Myocardial infarction (MI), Unstable angina pectoris, Percutaneous coronary intervention (PCI), Heart failure, Non-fatal stroke, Transient Ischaemic Attack (TIA), Lower limb amputation, Revascularization, Hypoglycaemia, cardiovascular diseases (CV), Peripheral ischaemia, Angina, Neuropathy, Renal complications, Related retinopathy, Multiple complications/unspecified complications, Without complications. The identification of non-fatal stroke will be based on the ICD-10 diagnosis and exclude people where date of death is within 28 days after the diagnosis.
Description: Technical Summary
Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by the body's inability to produce sufficient insulin and/or properly use insulin. Overweight and obesity are closely linked to T2DM and increased body weight could potentially increase the risk of some diabetes related complications as well as the length of a hospital admission. For hospital admissions among people with T2DM , we will investigate the association between body weight (pre-hospitalisation body mass index, BMI) and hospitalisations in terms of the outcomes length of stay (LoS) and cost of stay (CoS). Hospital admissions will be classified according to pre-specified complication-related diagnoses/procedures. The effect of BMI categories will be modelled for each outcome separately using regression analysis for a) each pre-specified complication-related diagnosis/procedure, and b) overall, including the hospital admission classification as covariates. For the regression analysis, we will use Generalised Linear Models (GLMs), with normal distribution for LoS and for CoS a gamma model with logarithmic link function. We will also investigate the effect of BMI as a continuous variable and using alternative BMI categorisations. Finally, we will evaluate the effect of BMI, controlling for other covariates.
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Estimating the effect of statin and metformin on cancer incidence and mortality in national linked electronic health records: a CALIBER study — Spiros Denaxas ...
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Estimating the effect of statin and metformin on cancer incidence and mortality in national linked electronic health records: a CALIBER study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Xabier Garcia-de-Albeniz - Corresponding Applicant - Harvard University
Barbra Dickerman - Collaborator - Harvard University
Michail Katsoulis - Collaborator - Farr Institute of Health Informatics Research
Miguel Hernan - Collaborator - Harvard UniversityOutcomes:
Primary exposures: - Statin use - Metformin use Primary outcomes: - Cancer incidence - All-cause and cancer-specific mortality
Description: Technical Summary
We will leverage the CALIBER dataset of linked CPRD, HES and ONS data to examine the effect of statins and metformin on the risk of cancer incidence and mortality. We will use this observational data to mimic the eligibility criteria, treatment strategies, and outcomes of a clinical trial. We will then estimate the effects of initiating therapy and of initiating and continuing therapy. To study the effect of treatment initiation, we will emulate a series of nested trials comparing initiators vs. non-initiators of the medications of interest. To study the effect of treatment initiation and continuation, we will implement and compare two approaches (g-methods) to adjust for time-varying confounding: inverse-probability weighting and the parametric g-formula.
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Sulphonylurea treatment and risk of myocardial infarction and all-cause mortality: a population-based cohort study — Frank de Vries ...
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Sulphonylurea treatment and risk of myocardial infarction and all-cause mortality: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Andre Krings - Collaborator - Atrium MC
Andrea Burden - Collaborator - ETH Zurich
Johanna Driessen - Collaborator - Utrecht University
Judith van Dalem - Collaborator - Utrecht University
Martijn Brouwers - Collaborator - Maastricht University
Olaf Klungel - Collaborator - Utrecht UniversityOutcomes:
Risk of myocardial infarction; Risk of all-cause mortality.
Description: Technical Summary
This study's primary objective is to evaluate the effect of current use of different types of sulphonylureas (SUs) only and the risk of myocardial infarction (MI). Our primary analysis will compare gliclazide (reference group) and glimepiride (primary exposure group). Additional analyses will compare gliclazide users with users of other sulphonylureas or other non-insulin antidiabetic agents (NIAAs). Our secondary objective is to evaluate the effect of current use of different types of sulphonylureas (SUs) only and the risk of all-cause mortality. Within the CPRD, all adult patients with at least one NIAA prescription will be selected. The exposure of interest is use of SUs in patients with type 2 diabetes mellitus (T2DM). Exposure will be assessed in a time-dependent manner. Adjusted cox regression models will be used to derive hazard ratios for the association between use of different SUs and the risk of all-cause mortality and myocardial infarction.
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An evaluation of the prevalence, epidemiology and burden of illness of hypophosphatasia (HPP) in the United Kingdom. — Christopher Morgan ...
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An evaluation of the prevalence, epidemiology and burden of illness of hypophosphatasia (HPP) in the United Kingdom.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-17
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Richard Eastell - Collaborator - University of Sheffield
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Prevalence of hypophosphatasia; All-cause mortality and causes of death; NHS resource use associated with hypophosphatasia; Prevalence and incidence of depression and anxiety in hypophosphatasia; Clinical manifestations of hypophosphatasia.
Description: Technical Summary
We aim to estimate the prevalence of hypophosphatasia (HPP) in a UK population based on CPRD and to characterize its epidemiology in terms of healthcare-resource use, mortality and morbidity. Patients will be included based on two algorithms: one based on diagnostic codes (Read or ICD-10); the other also including patients with low alkaline phosphatase levels, and will be ascribed suspected or uncertain HPP status accordingly. Main analyses will consider suspected HPP cases, with sensitivity analyses performed on all cases and those eligible for linkage to HES and ONS mortality data. Period prevalence will be calculated for 2015, based on patients registered with an up-to-standard practice at 30 June 2015. Clinical manifestations will be determined in CPRD GOLD by Read codes and test results and in HES by ICD-10 and OPCS codes. Deaths and causes of death will be ascertained from CPRD GOLD and ONS data. Frequency of healthcare use, as primary-care contacts, inpatient episodes, outpatient attendances, and prescriptions issued in primary care, will be calculated. Results will be tabulated with wide granularity, ensuring that cells with n<5 are suppressed in accordance with CPRD guidelines to prevent deductive/unintentional disclosure.
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Unintended effects of zaleplon, zolpidem, zopiclone (Z-drugs) use for sleep disturbance in people with dementia — Kathryn Richardson ...
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Unintended effects of zaleplon, zolpidem, zopiclone (Z-drugs) use for sleep disturbance in people with dementia
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-01
Organisations:
Kathryn Richardson - Chief Investigator - University of East Anglia
Kathryn Richardson - Corresponding Applicant - University of East Anglia
Antony Arthur - Collaborator - University of East Anglia
Chris Fox - Collaborator - University of East Anglia
Clare Aldus - Collaborator - University of East Anglia
Clive Ballard - Collaborator - University of Exeter
George Savva - Collaborator - University of East Anglia
Ian Maidment - Collaborator - Aston University, Birmingham
Nicholas Steel - Collaborator - University of East Anglia
Penelope Boyd - Collaborator - University of East Anglia
Robert Howard - Collaborator - UCL Hospital
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Specific outcomes: 1. Incident (a) fracture (any location) (b) hip fracture (c) forearm fracture. Hip fracture recording in CPRD has been well validated (PPV of 91%). 2. Incident fall. GP records of falls may under-represent all falls that occur in the older population, but more accurately represent 'injurious falls requiring medical attention'. 3. Mortality (based on CPRD GOLD's death dates). 4. Incident (a) infection (any), (b) urinary tract infection or respiratory infections, (c) antibiotic use. Respiratory tract infection has been validated in CPRD (PPV of 97%). 5. Stroke. Stroke has been well validated in CPRD. 6. Venous thromboembolism. Diagnosis in CPRD has been validated (PPV of 94%). 7. Incident agitation/psychosis. Psychosis diagnosis has been validated in CPRD (PPV of 93%), but the symptoms may be under-reported. 8. Additional medication use: (a) sedatives and other sleep medications (ATC N05C or N05BA), (b) antipsychotics (ATC N05A), (c) antidepressants (ATC N06A) 9. Health care utilisation: number of GP visits; hospital admissions..
Description: Technical Summary
Objective: To estimate the unintended consequences of Z-drugs (zolpidem, zaleplon and zopiclone) when used for sleep disturbance in people with dementia (PwD). Methods Cohort study of UK patients diagnosed with dementia since the year 2000 with first evidence of sleep disturbance post dementia diagnosis. Evidence of sleep disturbance is defined as the first of a diagnosis/symptom code for sleep disturbances or for a prescription of a Z-drug, low dose tricyclic antidepressant (LDTCA) or melatonin (index date). We will follow patients for the following outcomes: falls, fractures, infections, stroke, venous thromboembolism, mortality, agitation/psychosis, new medication use, and healthcare utilisation. Sleep medication classes considered as exposures include Z-drugs, benzodiazepines, melatonin, and LDTCA. Statistical analysis Hazard ratios associated with any prescription from each sleep medication class compared to no sleep prescription for each binary outcome shall be estimated using Cox regression models adjusted for a range of potential confounders. Negative binomial regression will be used to calculate incidence rate ratios for the number of GP visits and hospital visits in the two years post index date. Sleep medication exposure will be modelled as time-varying, such that PwD at the index date will be included for analysis in the 'no treatment' group until initiation of their first treatment.
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The role of the microbiome in joint and bone disease — Navraj Nagra ...
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The role of the microbiome in joint and bone disease
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Navraj Nagra - Chief Investigator - University of Oxford
Navraj Nagra - Corresponding Applicant - University of Oxford
Andrew Carr - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah Snelling - Collaborator - University of OxfordOutcomes: none known
Description: Technical Summary
Aims. To study the association between gastrointestinal microbiome altering drug (GMAD) treatment and osteoarthritis, osteoporosis, tendinopathy via dysbiosis.
To confirm the association between dysbiosis and rheumatoid arthritis and ankylosing spondylitis.
Data sources: Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES).
Population/Sample size: Minimum of 480,000 patients aged 18 and over in CPRD with a minimum of 1 year prior to the index date. The study has been powered to detect an association with an OR of 1.1.
Study Type: Nested case-control study. Sub analysis with inflammatory bowel disease will be considered.
Control: Five age, gender and practice matched patients.
Outcomes: Osteoarthritis, osteoporosis and tendinopathy, RA and ankylosing spondylitis identified by read codes.
Exposures: GMAD treatment
Statistical analysis: Conditional logistic regression, Propensity score analysis.
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Evaluation of the risk of intracranial and gastrointestinal bleeding events in patients concurrently prescribed non-steroidal anti-inflammatory drugs and SSRI antidepressants. — Ian Douglas ...
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Evaluation of the risk of intracranial and gastrointestinal bleeding events in patients concurrently prescribed non-steroidal anti-inflammatory drugs and SSRI antidepressants.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Bruce Guthrie - Collaborator - University of Edinburgh
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rupert Payne - Collaborator - University of Bristol
Stewart Mercer - Collaborator - University of EdinburghOutcomes: none known
Description: Technical Summary
The objective of this study is to estimate the strength of the association between concurrent exposure to non-steroidal anti-inflammatory drugs and antidepressants and both gastrointestinal bleeding and intracranial haemorrhage. This association will be compared to exposure to each drug individually and to neither drug. The study will include a cohort of patients with no history of bleeding events and no prior exposure to either drug class. A Poisson regression model will be used to estimate the hazard ratio for each exposure compared to patients on neither drug.
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Assessment of the rate of vaccine co-administrations with Bexsero — Olivia Mahaux ...
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Assessment of the rate of vaccine co-administrations with Bexsero
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-01
Organisations:
Olivia Mahaux - Chief Investigator - GlaxoSmithKline - UK
Emmanuel ARIS - Corresponding Applicant - GSK
Lingling Yue - Collaborator - GSK Vaccines
Vincent Bauchau - Collaborator - UCB Pharma SA - UKOutcomes:
Age at Bexsero vaccination; Type of vaccinations occurring on the same day as Bexsero.
Description: Technical Summary
The aim of this analysis is to obtain the distribution of age at administration of first, second, third, fourth or any dose of Bexsero vaccine and the frequencies of single and multiple co-administrations with Bexsero by age group. This will be performed in the CPRD. The observation period will start from September 1st, 2015 up to the latest available date by the time of this analysis (currently June 2016 for the 2016 Q3 release). This corresponds to the period from which Bexsero was introduced in the NHS Childhood Immunisation Program in England, in which infants are offered the MenB vaccine together with other routine vaccinations at 2 months, 4 months and 12 to 13 months of age. This knowledge will support pharmacovigilance evaluations (including the design of pharmacoepidemiological studies) of safety signals occurring after administration of Bexsero.
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Developing a co-morbidity tool to predict mortality for linked primary and secondary care data. — Colin Crooks ...
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Developing a co-morbidity tool to predict mortality for linked primary and secondary care data.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Colin Crooks - Corresponding Applicant - University of NottinghamOutcomes:
Dates of all-cause mortality for the whole cohort will be extracted from the linked data using the Office of National Statistics death register. All deaths in England are coded and recorded in the Office of National Statistics Death register from death certificates using the standardised rules established by WHO. Deaths from all causes within the 4 years of follow up will define the outcome events for the cohort.
Description: Technical Summary
Identifying patterns of co-morbidity that predict patient groups with reduced survival can identify risk groupings that can be used to adjust for case mix. However, the quantity of clinical coding in linked routine datasets means that systematically assessing each potential combination through traditional statistical methods is not feasible. Previous work has used Bayesian information sharing between similar codes in a fixed a priori hierarchy. This current proposal will use supervised learning to identify a bespoke hierarchy, allowing codes from different disease categories to be grouped together. The method uses latent Dirichlet allocation to learn a latent distribution for these categories. This has been adapted to be supervised by a penalised Cox proportional hazards model predicting mortality will be fitted using cyclical coordinate descent so as to be stable with high dimensional data. In particular, this topic modelling method allows for heterogeneous sub groups for which different combinations of predictors might be relevant. This better reflects the case mix of patients in the general population and might therefore should better adjust for this case mix in future studies.
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A Drug Utilisation Study of domperidone in the United Kingdom using Clinical Practice Research Datalink (CPRD) — Catrina Richards ...
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A Drug Utilisation Study of domperidone in the United Kingdom using Clinical Practice Research Datalink (CPRD)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-02
Organisations:
Catrina Richards - Chief Investigator - IQVIA Ltd
Sarah Jenner - Corresponding Applicant - IQVIA Ltd
Carlo Appiani - Collaborator - Janssen France
Daniel Fife - Collaborator - Johnson & Johnson ( JnJ - USA )
Janette McQuillan - Collaborator - IQVIA ( IMS Health ) France
Louise Raiteri - Collaborator - IQVIA - UK
Peter Hu - Collaborator - Janssen France
Susan Oliveria - Collaborator - IQVIA
Syd Phillips - Collaborator - IQVIA
Ute Richarz - Collaborator - Janssen FranceOutcomes:
Demographics: Information on patients'age, sex, and geographic region will be extracted. Diagnoses will be extracted from a read codes or will be determined based on laboratory test results. Indication: Estimated from the diagnoses recorded in the time period preceding each domperidone prescription: The indication for the prescription will be defined as nausea/vomiting if the subject has a recorded diagnosis classified as nausea or as vomiting, on the day of the prescription or in the preceding 7 days. For those prescriptions whose indication is not defined as nausea/vomiting, the indication will be defined as off-label if the subject has, in the 2 months up to and including the date of domperidone prescription, a diagnosis classified as one of the following: - GERD; - Abdominal bloating, gastric dysmotility, delayed gastric emptying; - Irritable bowel syndrome (IBS); Suppressed lactation, failed lactation, lactation not established, decreased lactation, lactation problem; or - Orthostatic hypotension and a diagnosis of Parkinson's disease. For those prescriptions not classified as above, the indication will be classified as unknown.
Description: Technical Summary
This study will use primary care data from CPRD to describe the drug utilisation patterns of domperidone pre- and post-implementation of the risk minimisation measures in 2014. Data analysis will be descriptive and presented using appropriate descriptive statistics such as mean, median, standard deviation and range for continuous variables and percent and frequency tables for categorical variables. Endpoints such as daily dose, duration of use, and prescribing for off-label indications will be measured for both groups. Additionally, estimates of the overall proportion of domperidone prescriptions before and after the risk minimisation implementation will be used to generate a risk ratio with 95% confidence intervals for each of the components of the composite endpoints individually, the time trend of apparent indication, days supplied (<7 days vs. >7 days), and the age and sex of the people receiving prescriptions. To account for the uncertainty around unknown indication and duration of use the rates for the endpoints will be calculated four ways from optimistic scenario (unknown indication on label usage for <7 days) and pessimistic scenario (unknown indication assumed to be off-label usage for >7 days), plus other intermediate scenarios.
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Use of hormone replacement therapy and risk of venous thromboembolism — Yana Vinogradova ...
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Use of hormone replacement therapy and risk of venous thromboembolism
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-17
Organisations:
Yana Vinogradova - Chief Investigator - University of Nottingham
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Carol Coupland - Collaborator - University of Nottingham
Julia Hippisley-Cox - Collaborator - University of OxfordOutcomes:
Incidence of venous thromboembolism.
Description: Technical Summary
Objective: The study will investigate risks of incident venous thromboembolism (VTE) associated with different types of hormone replacement therapy (HRT). Methods: This will be a nested case-control study. Cases will be women with incident VTE diagnosed between 1990 and 2016, matched with up to 5 controls by age, sex, practice and calendar year. Cases will be identified using GP and HES data. Analysis: Exposure to different HRTs will be defined as at least one prescription for that HRT in the year before the index date (date of diagnosis of VTE or equivalent date in matched controls). Conditional logistic regression will be used to assess the risks associated with different types of oestrogen and progesterone. The effects of duration, length of any gap since the last use and route of application will be analysed for most common types of the hormones.
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Potentially inappropriate prescribing in people with dementia in England: a prospective cohort study. — George Savva ...
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Potentially inappropriate prescribing in people with dementia in England: a prospective cohort study.
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
George Savva - Chief Investigator - University of East Anglia
Bryony Porter - Corresponding Applicant - University of East Anglia
Antony Arthur - Collaborator - University of East Anglia
David Wright - Collaborator - University of East Anglia
Duncan Edwards - Collaborator - University of Cambridge
Kathryn Richardson - Collaborator - University of East Anglia
Nicholas Steel - Collaborator - University of East Anglia
Nicholas Steel - Collaborator - University of East AngliaOutcomes:
We will extract prescription records for the selected potentially inappropriate medications, defined using World Health Organisation Anatomical Therapeutic Chemical Classification System (ATC) codes. The presence of each of the following PIMs will be coded within each of 12 2-month time periods between January 2015 and December 2016 for each patient conditional on their inclusion in the study for the whole of that period. 1. Antipsychotic medication will be defined using ATC code N0A5A. 2. Tricyclic antidepressants will be defined using ATC codes. Antidepressants (ATC N06A) are grouped into tricyclic antidepressant sub-type, according to ATC cross-referenced with the British National Formulary (BNF) to identify those used in UK practice (ATC N06AA02, N06AA03, N06AA04, N06AA06, N06AA07, N06AA09, N06AA10, N06AA12, N06AA16, N06AX03 and N06AX05). 3. Definite anticholinergic medication will be defined as any medication with an Anticholinergic Cognitive Burden (ACB) score of 3. An ACB=3 score indicates medications with definite anticholinergic activity and severe negative cognitive effects. 4. Proton pump inhibitors are implicated as potentially inappropriate, according to Beer's and STOPP criteria when they are used to treat peptic ulcer disease at maximum therapeutic dose for >8 weeks. Their use will be defined using ATC code A02BC, at maximum dose and the presence of a Read code indicating peptic ulcer disease (J13y200, J13z.00, 12E1.00, 14C1.00, J130200, J13y100, J13..00). 5. A binary indicator representing the use of any of the above PIMs 6. A continuous indicator of the total number of prescribed medicines within the 2-month time periods. This will include all prescribed medications but exclude devices, dressings and topical preparations. All health outcomes will be measured as the presence of a prescription at any point within the 2-month time periods.
Description: Technical Summary
Objective: To estimate the (i) prevalence of potentially inappropriate medication use, and overall medication burden among people with dementia between 2015 and 2016 (ii) and the factors associated with potentially inappropriate medication use, in particular the effect of medication reviews and dementia annual review. Methods. A 2-year cohort study following all prevalent cases of dementia at the start date of 01/01/2015, and incident cases between the start date and the study end date of 31/12/2016. Prescriptions of four classes of potentially inappropriate medications (antipsychotics, tricyclic antidepressants, anticholinergics and proton pump inhibitors) will be extracted, as well as any medication review or dementia annual review (exposures) during that period and potentially confounding variables. Statistical analysis. We will estimate the prevalence of potentially inappropriate medication use in people with dementia across the study period. McNemar and Wilcoxon signed rank tests will test the change in each outcome before and after a medication review or dementia annual review. Multilevel logistic regression analyses will then be used to estimate the factors associated with each outcome, and in particular the effect of medication review or dementia annual review on subsequent prescriptions controlling for age, sex, time varying comorbidity, area-level deprivation, GP practice and exception from QOF dementia indicators.
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Association between Rheumatoid Arthritis and comorbidities: a combined retrospective case-control and prospective cohort study. — Abhishek Abhishek ...
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Association between Rheumatoid Arthritis and comorbidities: a combined retrospective case-control and prospective cohort study.
Datasets:GP data, [1] Charlson comorbidities and other comorbidities (before, at the time of and after diagnosis of Rheumatoid Arthritis):cardiac arrhythmias, valvular heart disease, hypertension, hyperlipidaemia, multiple sclerosis, urolithiais, anaemia, depression, psychosis, hypothyroidism, psoriasis, gout, osteoarthritis. The definitions of these conditions will be based on physician diagnoses recorded as Read codes. [2] Total Charlson score [3] Death
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-01
Organisations:
Abhishek Abhishek - Chief Investigator - University of Nottingham
Abhishek Abhishek - Corresponding Applicant - University of Nottingham
Chang-Fu Kuo - Collaborator - University of Nottingham
Christian Mallen - Collaborator - Keele University
Michael Doherty - Collaborator - University of Nottingham
TingTing Chung - Collaborator - University of NottinghamOutcomes:
[1] Charlson comorbidities and other comorbidities (before, at the time of and after diagnosis of Rheumatoid Arthritis):cardiac arrhythmias, valvular heart disease, hypertension, hyperlipidaemia, multiple sclerosis, urolithiais, anaemia, depression, psychosis, hypothyroidism, psoriasis, gout, osteoarthritis. The definitions of these conditions will be based on physician diagnoses recorded as Read codes. [2] Total Charlson score [3] Death
Description: Technical Summary
Objectives: To compare the burden of comorbidity between incident cases of RA and matched controls before and after the diagnosis of RA. Methods: A combined retrospective case-control and prospective cohort study. Incident RA cases will be sampled from the CPRD, and age, gender, practice and index date matched with a control without RA. Comorbidities within 10 years prior to and following the diagnosis of RA will be analysed. Data from linkages is not required in this study. Data analysis: For retrospective analysis, the prevalence of a specific comorbidity will be calculated using the number of people ever diagnosed with a given comorbidity during the past 10-year period or 1-year period before the index date as the numerator and the number of patients with incident RA or matched controls as denominators. ORs and 95% CIs will be used to estimate the association. Conditional logistic regression will be used to adjust for covariates. For prospective analysis, Kaplan-Meier plots will be used to estimate the cumulative probability of each comorbidity and all-cause mortality in people with incident RA and those without. Hazard ratio (HR) and 95% CI will be calculated using a Cox proportional hazard model and adjusted for covariates.
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The effect of month of birth on the risk of being diagnosed with learning disability and depression. — Ian Douglas ...
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The effect of month of birth on the risk of being diagnosed with learning disability and depression.
Datasets:GP data, HES Admitted Patient Care; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Adrian Root - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jeremy Brown - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Joseph Hayes - Collaborator - University College London ( UCL )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Incidence of learning disability; Incidence of attention deficit disorder; Incidence of depression.
Description: Technical Summary
This observational study will explore the association between month of birth relative to school entry cut-off age and three outcomes: diagnosis of learning disability, diagnosis of ADHD and diagnosis of depression in children up until the age of 16 years. All children up to 16 years of age in up to standard practices will be included in the study. Relative age compared to the oldest of the school cohort will be calculated by comparing month of birth with the school entry cut-off. This will be categorised into four 3-month relative age bands. Cox regression will be used to determine the relative rate of each diagnosis by relative age band. Age in years, year of birth, socioeconomic status (measured by practice level IMD) will be considered potential confounders and gender and ethnicity and will be considered as potential effect modifiers. The above analyses will be used to estimate the population attributable risk from relative age and the number of 5 year olds entering school now who will receive a diagnosis as a result of their relative age in the school year.
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The Risks of Mortality, Cardiovascular Events, and Diabetes Associated With Statin Use In Patients With Rheumatoid Arthritis — Samy Suissa ...
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The Risks of Mortality, Cardiovascular Events, and Diabetes Associated With Statin Use In Patients With Rheumatoid Arthritis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-01
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Gulsen Ozen - Collaborator - University of Nebraska
Kaleb Michaud - Collaborator - University of Nebraska
Marie Hudson - Collaborator - McGill University
Rui Nie - Collaborator - McGill University
Sofia Pedro - Collaborator - National Databank fo Rheumatic Diseases
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes: none known
Description: Technical Summary
Statins decrease cardiovascular (CV) morbidity and mortality while increasing the risk of type 2 diabetes mellitus (T2DM). Despite their frequent use, the net effect of statins in rheumatoid arthritis (RA) patients in which insulin resistance, T2DM, CV, and overall mortality risks are already increased due to chronic inflammation and glucocorticoid use, have not been evaluated comprehensively. We will compare effects of statins on incident T2DM, CV events, and mortality in RA patients in comparison with non-RA patients in the Clinical Practice Research Datalink. Statin-initiator RA patients without T2DM will be identified and each will be matched (1:5) with statin non-initiator RA patients, statin-initiator and non-initiator non-RA patients based on age, sex, study period, body mass index, other comorbidities and medications influencing the development of T2DM, CV events, and mortality. Cox proportional hazard models will be constructed to assess the statin-associated risks and benefits in each group. We will also calculate numbers needed to treat and harm with statins for each group. We will determine if statins increase T2DM risk with a more significant improvement in CV morbidity and mortality in RA patients, and identify potential risk factors for T2DM development with statins. Thereby, monitoring and preventive measures could be developed.
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Changes over time in the monitoring of cardiovascular risk in primary care, and the use of statins for the primary and secondary prevention of cardiovascular disease. — Krishnan Bhaskaran ...
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Changes over time in the monitoring of cardiovascular risk in primary care, and the use of statins for the primary and secondary prevention of cardiovascular disease.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-22
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sarah Gadd - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Anthony Matthews - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Statin prescription; Cardiovascular risk score record.
Description: Technical Summary
There has recently been much interest in the practice of prescribing statins to prevent cardiovascular disease. The National Institute for Health and Care Excellence currently recommends the prescription of stations for: (i) primary prevention of cardiovascular disease, following a ten year cardiovascular risk score of 10% (prior to 2014 this threshold was 20%); and (ii) secondary prevention following a cardiovascular event. Using primary care data from the Clinical Practice Research Datalink, we will first describe trends in cardiovascular risk monitoring among people with no prior cardiovascular disease. Among people eligible to start a statin, logistic regression will be used to look at calendar time changes in, and other factors associated with, initiating a statin. Patterns of statin adherence will be described, and discontinuation will also be examined using time-to-event methods. This study will provide insight into how well routine practice is aligned with clinical guidelines, and help generate hypotheses about which patient groups are not initiating, or are discontinuing, statin use.
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Trajectories of metabolic and clinical parameters prior to the onset of dementia in people with Type 2 diabetes — Christopher Millett ...
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Trajectories of metabolic and clinical parameters prior to the onset of dementia in people with Type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Christopher Millett - Chief Investigator - Imperial College London
Eszter P Vamos - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Lefkos Middleton - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College LondonOutcomes:
Dementia - To ascertain the development of dementia during the study period in the initially dementia-free cohort of patients with T2D, the presence of diagnostic read codes for vascular dementia, Lewy body dementia, Alzheimer's dementia and other non-vascular forms of dementia will be identified using 1. Diagnostic read codes from primary care records; 2. Prescription data from primary care records; 3. HES data including primary and secondary diagnostic codes on admission; 4. ONS mortality data; 5. MMSE scores using primary care data. Death - Date and cause of death. Diagnostic codes will be used to triangulate dementia diagnosis. In survival analyses death-censored outcome of dementia will be examined as well as death as a competing outcome to dementia.
Description: Technical Summary
This study will be a retrospective open cohort study of adults with Type 2 Diabetes from the CPRD. Dementia-free adults with Type 2 Diabetes over the age of 45 years will be followed up from 1 April 2004 to 30 September 2016. The primary outcome if interest will be the diagnosis of dementia (categorised as vascular dementia, Alzheimer's dementia or other dementia). We will characterise the retrospective trajectories of glycated haemoglobin, cholesterol and blood pressure among patient who develop and those who do not develop dementia during the study period. Multilevel growth models will be utilised to compare trajectories of the metabolic parameters in the dementia and non-dementia groups. Patients will be categorised according to HbA1c, SBP, DBP and lipid measure segments and we will use survival analyses to estimate the risk of dementia by levels of metabolic parameters. Survival analyses will be used to assess the link between microvascular (retinopathy, nephropathy, neuropathy) and macrovascular disease (AMI, stroke, TIA and death due to acute CVD events) and the development of dementia. We will further assess the association between these parameters and survival after the diagnosis of dementia. Subgroup analyses by ethnicity, socio-economic deprivation, sex and the presence of hypertension will be performed.
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Extreme restriction design as a method for removing confounding by indication in pharmacoepidemiologic research — Samy Suissa ...
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Extreme restriction design as a method for removing confounding by indication in pharmacoepidemiologic research
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Carla Doyle - Collaborator - McGill University
Colin Dormuth - Collaborator - McGill University
Laura Targownik - Collaborator - McGill University
Matthew Dahl - Collaborator - McGill University
Matthew Secrest - Collaborator - McGill University
Robert Platt - Collaborator - McGill University
Rui Nie - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Hospitalisation for community-acquired pneumonia
Description: Technical Summary
We propose restriction to a single indication as a method to reduce confounding by indication in observational pharmacoepidemiologic research when common restriction approaches are insufficient. We will outline our method (called âextreme restrictionâ) and present its use in a case study of PPIs and the risk of HCAP. PPI use has been associated with an increased risk of pneumonia, but this association is likely the result of confounding by indication due to GERD. Using the CPRD linked to the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases, we will estimate the effect of PPIs on HCAP in a series of retrospective cohort studies comparing incident PPI users to new users of active comparators (i.e., histamine-2 receptor agonists, H2RAs), new users of comparator drugs with no known pneumonia effects (i.e., treatments for glaucoma/ocular hypertension, osteoporosis, depression, and hypothyroidism), and randomly-selected candidates for PPI use. We will then repeat our analyses on an extremely restricted cohort of incident NSAID users, some of whom take PPIs prophylactically and are thus unlikely to have GERD. All analyses will use multivariate Cox proportional hazards models adjusted for deciles of high-dimensional propensity score (using >500 empirically-selected covariates) with exposures fixed at cohort entry.
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Comparative effectiveness and safety of novel oral anticoagulants in atrial fibrillation — Samy Suissa ...
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Comparative effectiveness and safety of novel oral anticoagulants in atrial fibrillation
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
James Brophy - Collaborator - McGill University
Simone Loo - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Ischemic stroke/systemic embolism; Intracerebral bleeding; Myocardial infarction; Major bleeding; All-cause mortality.
Description: Technical Summary
We will create a cohort of all adult AF patients with a first-time prescription for NOAC or VKA between 1 August 2011 and 30 September 2016. Patients newly exposed to NOAC at cohort entry will be matched on high-dimensional propensity score in a 1:1 ratio to patients newly exposed to VKA. The main outcomes of interest will be ischemic stroke/systemic embolism and bleeding, which will be assessed separately. A Poisson model will be used to calculate cumulative incidence rates in patients newly exposed to NOAC and VKA. Cox regression will be used to estimate the hazard ratio of each individual outcome, in patients exposed to NOAC compared to patients exposed to VKA. Separate models will be constructed using different measures of exposure. In the first model, patients will be censored when stopping or switching anticoagulant treatment group whereas in the second model, exposure to anticoagulant will be time-dependent. All analyses will be conducted for the general AF population, as well as for subgroups of AF patients with chronic kidney disease, and a history of stroke/transient ischemic attack. Several sensitivity analyses will be conducted to evaluate the robustness of the primary results.
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Exploring prescribing patterns, treatment trajectory and healthcare resources use of breast cancer patients in primary care to inform community pharmacy services for breast cancer survivors in England — Li...
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Exploring prescribing patterns, treatment trajectory and healthcare resources use of breast cancer patients in primary care to inform community pharmacy services for breast cancer survivors in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-14
Organisations:
Li-Chia Chen - Chief Investigator - University of Manchester
Claire Anderson - Collaborator - University of Nottingham
Lydia Tutt - Collaborator - University of Nottingham
Tracey Thornley - Collaborator - Boots UKOutcomes: none known
Description: Technical Summary
The improvement in breast cancer survival has led to an increasing demand for breast cancer focused primary care services due to the increasing requirements of long-term breast cancer therapy and survivor support. Therefore, there is a scope for community pharmacy to take on a larger role. To facilitate the development of pharmacy services for breast cancer survivors, research into current treatment pathways and care needs is required. This retrospective cohort study aims to explore medicine utilisation patterns and treatment trajectory for breast cancer survivors in Englandâs primary care setting using the Clinical Practice Research Datalink data from November 2005 to October 2015. Newly diagnosed female breast cancer patients will be selected and followed from the date of discharge from hospital after initial breast cancer treatment until either leaving their general practice; death; or the end of the study. Patients with a 2-10 year follow-up period will be included and their characteristics (i.e. age at baseline, ethnicity, follow-up and survival duration), medicine utilisation patterns (endocrine therapy and exposure time, interruptions, and commonly prescribed non-cancer-related prescriptions), follow-up endpoint, medical resource use (primary and secondary care visits, and cancer care review) will be measured and analysed by descriptive statistics and regression methods.
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The risk of cardiovascular diseases among survivors of site-specific adult cancers: a matched cohort study — Krishnan Bhaskaran ...
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The risk of cardiovascular diseases among survivors of site-specific adult cancers: a matched cohort study
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-02-01
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Alexander Richard Lyon - Collaborator - Imperial College London
Anthony Matthews - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Claire Lawson - Collaborator - University of Leicester
Helen Strongman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Isabel dos-Santos-Silva - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michael Sweeting - Collaborator - University of Leicester
Sarah Gadd - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Susannah Stanway - Collaborator - Royal Marsden Hospital
Umesh Kadam - Collaborator - University of LeicesterOutcomes:
- Cardiovascular diseases (coronary artery disease, arrhythmia, venous thromboembolism, cerebrovascular disease, other). - Cause-specific death (cardiovascular vs cancer vs other).
Description: Technical Summary
As medical care has improved, an increasing number of individuals are surviving cancer, and the population of survivors is growing. Cancer and its treatment may impact on the health of survivors throughout life, and there is evidence for an association between having a history of cancer and an increased risk of cardiovascular diseases (CVD). Some studies have looked at how specific cancer treatments affect the chances of developing CVD, but there is a need for a comprehensive study covering a range of cancer types and cardiovascular outcomes. This study will use survival analysis methods within a matched cohort study design; cancer survivors will be compared to controls with no history of cancer, and associations between site-specific cancer history and risks of a range of cardiovascular diseases will be estimated. This will help identify cancers that lead to a particularly high risk of certain cardiovascular diseases, and help identify priority areas for future research in cardio-oncology.
Source
2017 - 01
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The incidence and mortality of complicated diverticular disease and associated outcomes following intervention — David Humes ...
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The incidence and mortality of complicated diverticular disease and associated outcomes following intervention
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Diagnostic Imaging Dataset; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-13
Organisations:
David Humes - Chief Investigator - University of Nottingham
Harmony Otete - Corresponding Applicant - University Of Central Lancashire
Colin Crooks - Collaborator - University of Nottingham
Joe West - Collaborator - University of NottinghamOutcomes:
Objective 1: No outcome other than the occurrence of the disease is required for this analysis. Objective 2: Primary outcome measures are death and cause of death. Death will be defined based on recordings of death dates in CPRD, HES or ONS register. To define cause of death, the ONS death register would be used and underlying cause of death will be examined primarily categorized as ICD-10 chapter headings. Objective 3: Primary outcome measures are interventions and outcome of interventions ( readmission and reoperation). Using Linked HES data and OPCS codes, interventions undertaken following an admission with diverticular perforation or diverticular abscess will be identified. Identified interventions would be categorized into: 1. Conservative treatment (no surgical intervention/antibiotics) 2. Laparoscopic lavage 3. Resectional surgery (Hartmann's or resection and anastomosis) 4. Percutaneous drainage Using the same data, re-admission and surgical re-operation following conservative and minimally invasive interventions will be examined.
Description: Technical Summary
Diverticular disease is one of the most common problems encountered by general surgeons and gastroenterologists. Complications of diverticular disease such as perforation and abscess account for the majority of the morbidity and mortality associated with diverticular disease. Given the age and comorbidity of these patients and the high risks of stoma formation and death following surgery there has been interest in pursuing less invasive methods of treatment for these complications. The Association of Coloproctologists of Great Britain and Ireland undertook a modified Delphi exercise during 2014 and 2015 to prioritise research questions for Bowel Disease in conjunction with the Bowel Disease Research Foundation. One of the top ten priority questions in non-cancer diseases was to investigate short and long term outcomes of minimally invasive approaches (e.g. percutaneous radiological drainage, laparoscopic washout and drainage) to managing complicated diverticulitis. The aim of our study will first be to provide contemporary population based estimates of the incidence of perforated diverticular disease and diverticular abscess and quantify the attributable mortality after adjustment for baseline comorbidity. Then, using the cohorts defined, we aim to report the use of minimally invasive treatment strategies and their outcomes in patients with complicated diverticular disease(CDD).
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The Use of Angiotensin Converting Enzyme Inhibitors and the Risk of Lung Cancer — Samy Suissa ...
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The Use of Angiotensin Converting Enzyme Inhibitors and the Risk of Lung Cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-23
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Blánaid Hicks - Collaborator - Queen's University Belfast
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jacob (Jay) Udell - Collaborator - University of Toronto
Kristian Filion - Collaborator - McGill University
Lama Sakr - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill UniversityOutcomes:
The outcome of interest is a primary diagnosis of lung cancer, determined from GP recorded diagnostic/symptom codes, until the 30th September 2016 (end of study period).
Description: Technical Summary
Angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), are antihypertensive medications that act upon the renin angiotensin system to reduce blood pressure. While ACEIs have been shown to be relatively safe, recently the potential effects of ACEIs on lung cancer incidence has been subject to debate. Preclinical studies suggest that ACEIs may increase lung cancer incidence via the accumulation of bradykinin in the lung. However observational studies are limited and observed inconsistent results. Thus, the objective of this study will be to assess this association by assembling a study cohort of patients who initiated an antihypertensive medication on or after January 1 1995 until September 30, 2015. All patients will be followed until a first-ever diagnosis of lung cancer, or censored upon death, end of registration with the practice, or end of the study period (September 30, 2016). Time-dependent Cox proportional hazard models will be used to estimate hazard ratios and 95% confidence intervals of lung cancer associated with the use ACEIs when compared with the use of ARBs, with exposures lagged by 1 year for latency purposes. Secondary analyses will assess whether the risk varies according to cumulative duration of use and time since initiation.
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Developing Personalised Renal Function Monitoring for Heart Failure Patients — Darren Ashcroft ...
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Developing Personalised Renal Function Monitoring for Heart Failure Patients
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-26
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Ahmed Al-Naher - Corresponding Applicant - University of Liverpool
Bertram Muller-Myhsok - Collaborator - University of Liverpool
Heather A Robinson - Collaborator - University of Manchester
Jennifer Downing - Collaborator - University of Liverpool
Munir Pirmohamed - Collaborator - University of Liverpool
Niels Peek - Collaborator - University of Manchester
Paolo Fraccaro - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
The main objective of this study is to inform the development of personalised renal function guidelines in heart failure patients. In order to facilitate a personalised approach, a data-driven method is required to analyse individual factors which amplify the risk of renal decline with diuretics.
The method will involve extraction of patient information from all patients with a diagnosis of heart failure and associated clinical codes. Within this patient group we will be looking at occurrence of renal impairment via change in eGFR and creatinine biomarkers. We will examine the frequency of renal function monitoring during the study observation period. These results will then be mapped to patient factors which may conceivably impact renal function. Therefore co-variates would include a full list of prescribed medications in primary care, co-morbidities, other relevant investigations and interventions.
Due to the large number of estimated variables, we will incorporate machine learning algorithms for guideline generation. In particular, but not exclusively, we will combine Gaussian processes and change-point analyses as well as penalized linear methods to identify key predicting variables and time-points. This methodology will allow us to discover patient factors hitherto unexplored which impact patient risk of renal decline with medication, creating a truly personalised guidance to improve patient outcomes.
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Associations between absolute value, and change in value, of albumin-creatinine ratio and major adverse health outcomes — Mark Woodward ...
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Associations between absolute value, and change in value, of albumin-creatinine ratio and major adverse health outcomes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-23
Organisations:
Mark Woodward - Chief Investigator - The George Institute for Global Health
Mark Woodward - Corresponding Applicant - The George Institute for Global Health
Andrew S. Levey - Collaborator - William B Schwartz Division of Nephrology Tufts Medical Center
Brandon Neuen - Collaborator - The George Institute for Global Health
Clare Bankhead - Collaborator - University of Oxford
Colin Baigent - Collaborator - Johns Hopkins School of Medicine
Josef Coresh - Collaborator - Johns Hopkins School of Medicine
Kunihiro Matsushita - Collaborator - Johns Hopkins School of Medicine
Margaret Smith - Collaborator - University of Oxford
Morgan Grams - Collaborator - Johns Hopkins School of Medicine
Richard Hobbs - Collaborator - University of Oxford
Will Herrington - Collaborator - University of Oxford
Yingying Sang - Collaborator - Johns Hopkins School of MedicineOutcomes:
Renal outcomes will be derived as in our previous work in CPRD, using an algorithm incorporating death certificates, inpatient diagnostic or procedural codes, and primary care diagnostic/laboratory test results, and applying standard CKD definitions and creatinine-based CKD Epidemiology Collaboration (CKD-EPI) estimated GFR (eGFR) formulae25. CKD stages G4-G5 will be accepted if there were at least two eGFR measurements <30mL/min/1.73m2, spaced by at least 90 days, with no eGFR result >30mL/min/1.73m2 in the intervening period. The ESRD outcome will comprised those who died with mention of ESRD, or underwent kidney transplantation or maintenance dialysis (which was distinguished from acute dialysis by a record of CKD stage 5, permanent arteriovenous dialysis access or peritoneal dialysis). We have previously validated this algorithm using UK-renal registry data. CVD will be defined using primary care and linked HES and ONS mortality data using CALIBER definitions. Cardiovascular mortality will be defined as a death with Underlying Cause of Death attributed to a vascular cause (ICD-10 codes I00-I99 excluding I85) or sudden death (R96). Sensitivity analyses will include any mention of one of these codes on the death certificate.
Description: Technical Summary
We will include patients with at least one ACR measure to estimate the association between ACR (after a log transformation, based on our prior work) and (for example) CVD using Cox proportional hazards models. We shall examine the patterns of association using splines and by estimating hazard ratios between ordinal groupings of ACR. Adjustments will be made for confounding variables and subgroup analyses undertaken. The UK population attributable risk for each of these outcomes associated with micro- and macro-albuminuria will be estimated. We will select subjects in CPRD who have at least two ACRs within about 3 years (the exposure window) to estimate the change in ACR by fitting a linear regression line for each subject. We will then use similar methods to estimate associations of change in ACR with CVD, but adjusting additionally for (1) the first ACR; (2) the last ACR within the window. We will alternatively estimate change in ACR as the observed relative difference between the first ACR and that closest to 3 years later, for those with ACR measured after (approximately) 3 years. The length of the exposure window will be varied in sensitivity analyses. Missing values will be imputed using multiple imputation by chained equations.
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Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): A case control study using the Clinical Practice Research Datalink (CPRD). — Matthew Grainge ...
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Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): A case control study using the Clinical Practice Research Datalink (CPRD).
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-13
Organisations:
Matthew Grainge - Chief Investigator - University of Nottingham
Matthew Grainge - Corresponding Applicant - University of Nottingham
Blessing Nyakutsikwa - Collaborator - University of Nottingham
Chang-Fu Kuo - Collaborator - University of Nottingham
Luigi Naldi - Collaborator - Department of Dermatology, Azienda Ospedaliera papa Giovanni XXIII, Bergamo (Italy)
Michael Doherty - Collaborator - University of Nottingham
Robin Ferner - Collaborator - West Midlands Centre for Adverse Drug Reactions
Sonia Gran - Collaborator - University of NottinghamOutcomes:
Outcome 1 (case control analysis): The outcomes for the case-control study will be a clinical diagnosis of SJS/TEN identified using Read codes (primary care) and ICD-10 codes (secondary care). Outcome 2 (survival analysis): The outcome for the cohort mortality analysis will be 30-day mortality of the cases following a diagnosis of SJS/TEN. Outcome 3 (risk prediction model): Development of SJS/TEN within 28 days of a relevant prescription.
Description: Technical Summary
We will use data from the CPRD to answer the following questions: a. What is the risk of SJS/TEN for allopurinol, anti-epileptic, NSAID and anti-bacterial drug exposure compared with the general population and to explore the length of time between the drug exposure and diagnosis of SJS/TEN? (Case-control analysis) b. Among SJS/TEN cases, is the short-term mortality influenced by the drug (allopurinol, anti-epileptic, NSAID and anti-bacterial) which induced the reaction after adjusting for covariates? (Survival analysis) c. Develop and internally validate a prognostic model to establish factors which predict SJS/TEN following drug administration. (Risk prediction model) Cases will comprise people with a diagnosis of either SJS or TEN in their primary/secondary care record and each will be matched to 6 controls based on age, sex and practice. For objective a, we will compare prescriptions for the above drugs between cases and controls using conditional logistic regression (stratified by time prior to date of case diagnosis). For objective b, Cox regression will be used for statistical modelling along with Kaplan-Meier calculations to estimate 30 day mortality. For objective c, we will develop a risk score using a logistic regression model (outcome: SJS/TEN in the 28 days following a relevant drug prescription).
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Characterising the primary care population with frailty to better stratify and target healthcare interventions — Evangelos Kontopantelis ...
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Characterising the primary care population with frailty to better stratify and target healthcare interventions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-13
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
David Reeves - Corresponding Applicant - University of Manchester
Andrew Clegg - Collaborator - University of Leeds
Darren Ashcroft - Collaborator - University of Manchester
Harm Van Marwijk - Collaborator - Brighton and Sussex Medical SchoolOutcomes: none known
Description: Technical Summary
Advances in healthcare have increased lifespans for millions of people, but an important consequence is that increasing numbers of people are living with long-term conditions and progressive frailty. Health services tend to take a âreactiveâ approach which can lead to unnecessary increased disease burden and emergency hospitalizations. This has led to calls for a more pro-active approach. A general frailty indicator that can stratify patients by their overall risk of adverse health outcomes could help GPs in identifying cases where preventative actions would be most beneficial and where targeted interventions, such as supported self-management, assessment and goal-setting, or forms of homecare, can have maximum benefit.
The electronic Frailty Index (eFI) is a tool recently developed by the NIHR York and Humberside CLAHRC for constructing a measure of patient frailty from the primary care health record. We will implement this measure in the CPRD, to characterise the epidemiology of patient frailty, including incidence and prevalence and how these vary by age, sex, area deprivation, medical conditions and region; how frailty progresses in individuals over time; whether there are distinct sub-domains of frailty, such as physical and cognitive; relationships between frailty, receipt of drug treatments, and health outcomes including hospitalisation and death.
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A nested case-controlled study of the association between incident pneumonia, dysphagia and the formulation of commonly prescribed medication among people with dementia. — George Savva ...
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A nested case-controlled study of the association between incident pneumonia, dysphagia and the formulation of commonly prescribed medication among people with dementia.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-13
Organisations:
George Savva - Chief Investigator - University of East Anglia
Eleanor Dann-Reed - Corresponding Applicant - University of East Anglia
David Wright - Collaborator - University of East Anglia
Debi Bhattacharya - Collaborator - University of East Anglia
Eleanor Dann-Reed - Collaborator - University of East Anglia
Kathryn Richardson - Collaborator - University of East AngliaOutcomes:
Pneumonia: After a washout period of 3 months since dementia diagnosis, the first incidence of pneumonia shall be recorded by the presence of any READ codes.
Description: Technical Summary
We will conduct a case-control study nested within a cohort of dementia patients to determine whether there are associations between dysphagia and pneumonia and medicine formulations and pneumonia. Secondary objectives are to determine whether the presence of other hypothesised risk factors increase the odds of being diagnosed with pneumonia. All patients will have a diagnosis of dementia between 1987 and the practices last collection date. Cases will have a record of pneumonia (date of first pneumonia since dementia diagnosis is the index date). Controls will be matched by date of dementia diagnosis, age, region and index date in a ratio of 4:1 with no diagnosis of pneumonia up to the index date. The proportion and distribution of each exposure and covariate will be described for cases and controls. Conditional logistic regression models will be used to estimate (i) the effect of dysphagia and (ii) the moderating effect of medication formulation on any association between dysphagia and pneumonia incidence while controlling for other factors hypothesised to be linked to pneumonia. Odds ratios and 95% confidence intervals will be reported; p-values <0.01 shall be considered statistically significant. A sensitivity analysis will include only those with dysphagia to confirm previous methods and results.
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Determining incidence of patient safety events in primary care using patient record data — Paul Aylin ...
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Determining incidence of patient safety events in primary care using patient record data
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-19
Organisations:
Paul Aylin - Chief Investigator - Imperial College London
Danny Furnivall - Corresponding Applicant - Imperial College London
Alex Bottle - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
This study will attempt to capture the incidence of sentinel safety events in primary care (see appendix for proposed events)These events broadly fall into three categories: diagnostic errors, prescribing errors and administration errors (e.g. referrals not being mailed to patients).
The approach taken to capture these events within the data will vary depending on the type of event.
For example, when trying to capture the incidence of prescriptions made to those with allergies to the drug, the field âprescrâ will be used to determine whether a patient has previously been recorded as having a prescribing exemption. This will then be compared with the âbnfcodeâ field to determine whether the patient has been prescribed the drug they have previously had problems with. Another example is following up planned referrals for cancer, which will utilise the HES data linkage to determine whether or not a referral has resulted in a subsequent hospital visit.
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Proton pump inhibitor use and risk of iron deficiency: a case-control study. — Anthonius de Boer ...
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Proton pump inhibitor use and risk of iron deficiency: a case-control study.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-11
Organisations:
Anthonius de Boer - Chief Investigator - Utrecht University
An Tran-Duy - Corresponding Applicant - University of Melbourne
Arno W Hoes - Collaborator - Maastricht University
Coen Stehouwer - Collaborator - Maastricht University
Floris Vanmolkot - Collaborator - Maastricht University
Frank de Vries - Collaborator - Utrecht University
Manuela Joore - Collaborator - Maastricht University
Niek J de Wit - Collaborator - Maastricht University
Niels Connell - Collaborator - Maastricht University
Patrick Souverein - Collaborator - Utrecht UniversityOutcomes:
The primary outcomes of interest are the odd ratios of the first occurrence of iron deficiency in PPI full user compared to PPI non-users and to PPI limited users. The secondary outcomes of interest are the odd ratios of the first occurrence of iron deficiency in patients using PPIs with a defined drug dosage (DDD) of 1 compared to other DDDs, and with duration shorter than 1 year compared to other durations. The occurrence of iron deficiency will be identified using the CPRD clinical dataset based on the medical codes for iron deficiency, and using the CPRD therapy dataset based on the product codes for iron supplements.
Description: Technical Summary
Therapy with proton pump inhibitors (PPIs) may reduce iron absorption, leading to iron deficiency (ID). This study aims at investigating the effects of PPI use on the risks of ID. A case-control study will be conducted using the CPRD. Cases will be patients aged 19 years with first time diagnosis of ID and who received at least one prescription of iron supplement between 2005 and 2015. For each case, one control will be matched by age, gender and general practice, and assigned the same index date, i.e. the date of the first event in cases. A full PPI user will be a subject who receives PPIs for a continuous duration of 1 year prior to the index date, with the time gap between the index date and the last date of PPI use of 3 months. A limited PPI user will be a subject who received PPIs before the index date but does not sastify the criteria that defines a full PPI user. A PPI non-user will be one who received no prescription of PPIs prior to the index date. Conditional logistic regression will be used to estimate the odds ratio of iron deficiency in full or limited PPI users compared to PPI non-users. The model will be adjusted for definite blood loss, possible upper gastrointestinal blood loss, possible lower gastrointestinal blood loss, malabsorption, chronic diseases and inflammatory bowel disease.
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Potential benefits of antithrombotic treatment in reducing risk of subsequent cardiovascular events among patients with a prior myocardial infarction in England — Dimitra Lambrelli ...
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Potential benefits of antithrombotic treatment in reducing risk of subsequent cardiovascular events among patients with a prior myocardial infarction in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-18
Organisations:
Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Dimitra Lambrelli - Corresponding Applicant - Evidera, Inc
Cathy Anne Pinto - Collaborator - Merck Sharp & Dohme - UK
Laura McDonald - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Robert Donaldson - Collaborator - Evidera, Inc
Sharon MacLachlan - Collaborator - Evidera, Inc
Tommi Tervonen - Collaborator - Evidera, IncOutcomes:
All-Cause Mortality ; Cardiovascular (CV) death; CV death, excluding fatal bleed; Myocardial Infarction (MI); Non-fatal MI; Stroke; Ischemic stroke (IS); Non-fatal IS; Non-fatal intracerebral hemorrhage (ICH); Severe bleed, non-fatal, non-ICH; Moderate or severe bleed; Moderate bleed; Severe bleed; Fatal bleed
Description: Technical Summary
Patients with a history of myocardial infarction (MI) are at substantial risk of future atherothrombotic events (e.g., repeated MI, stroke, and cardiovascular [CV] death). Antithrombotic therapy is widely used to reduce the risk of subsequent ischemic events, but is known to increase the risk of bleeding among treated patients. A new treatment for secondary prevention of atherothrombotic events, called vorapaxar, has completed phase 3 trials in 2012. It is unclear how much the randomized controlled trial population, differs from the general population, how this subsequently impacts atherothrombotic risks, and how antithrombotic treatment may benefit patients in the real-world setting. Therefore, the purpose of this study is to investigate risks of subsequent atherothrombotic and bleeding events in patients with prior MI, matched and unmatched to those patients eligible for the vorapaxar trial, to determine risk factors for these events in these populations, and to quantify net clinical benefit of antithrombotic treatment in the real-world setting. To ensure all exposures and outcomes of interest are well-captured in this study, data from CPRD will be linked with data from HES, MINAP, and the ONS mortality register.
Source - and 11 more projects — click to show
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Investigation of the comparative safety of opioid drugs within CPRD- part of the International Pharmacosurveillance Study — Meghna Jani ...
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Investigation of the comparative safety of opioid drugs within CPRD- part of the International Pharmacosurveillance Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-26
Organisations:
Meghna Jani - Chief Investigator - University of Manchester
Meghna Jani - Corresponding Applicant - University of Manchester
DAVID JENKINS - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of Manchester
Michal Abrahamowicz - Collaborator - McGill University
Rikesh Patel - Collaborator - University of Manchester
Therese Sheppard - Collaborator - University of Manchester
William Dixon - Collaborator - University of ManchesterOutcomes:
Primary outcomes: All-cause mortality. Secondary outcomes: Cause-specific mortality; Fractures: hip, pelvis, wrist, humerus, vertebral, rib, lower limb; Cardiovascular: myocardial infarction, stroke/TIA; Gastrointestinal: constipation, bowel obstruction; Road Traffic Accidents.
Description: Technical Summary
Opioid use for non-cancer pain has increased significantly over the last 30 years. It has become increasingly apparent that opioids are associated with considerable risks and uncertain benefits. A number of safety outcomes have been associated with opioid use, however little is known about the comparative safety of opioids. Few studies have robustly assessed the effect of opioids on long-term outcomes, the effect of dose, potency, duration, and interactions with other commonly prescribed potentially harmful drugs. A retrospective cohort analysis will be conducted internationally across three countries for all new-users of opioids prescribed for non-malignant pain between 2006-2016, including the UK through CPRD. Descriptive analyses of opioid prescribing trends in each cohort will be followed by modelling of the associations of prescribed opioids with core safety outcomes of (i) all-cause mortality, (ii) cardiovascular outcomes (iii) fractures. Additionally gastrointestinal outcomes and road traffic accidents will be assessed within CPRD. This work will help clinicians and patients understand better the risk profile of opioids to allow informed decision making, based on the resulting insights about potential deleterious effects to patients. Additionally, it will allow improved understanding of the effects of dose, treatment duration, and interactions with other common co-medications such as benzodiazepines.
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Effects of changing pre-eclampsia management on acute renal failure and other maternal and perinatal outcomes in the United Kingdom: An interrupted time-series analysis — Samy Suissa ...
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Effects of changing pre-eclampsia management on acute renal failure and other maternal and perinatal outcomes in the United Kingdom: An interrupted time-series analysis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-23
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Anne-Marie Cote - Collaborator - University Of Sherbrooke
Azar Mehrabadi - Collaborator - Dalhousie University
Erin C. Strumpf - Collaborator - McGill University
Kate Bramham - Collaborator - King's College London (KCL)
Laura A. Magee - Collaborator - St George's, University of London
Lisiane Leal - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
The primary outcome will be the occurrence of acute renal failure, defined are occurring during the delivery episode or within 42 days of delivery within ICD-10 codes or Read codes. Secondary maternal outcomes will be assessed using a composite outcome of pulmonary oedema and other complications associated with hypertensive disorders of pregnancy including eclampsia, stroke, transient ischemic attack, retinal detachment, hepatic failure, hematoma or rupture, myocardial infarction, placental abruption or receipt of a blood transfusion, and intensity of anti-hypertensive treatment, as diagnosed in either the CPRD Gold or the HES in the delivery episode or 42 days postpartum. Secondary fetal or newborn outcomes (perinatal) will be assessed using a composite outcome of pregnancy loss (miscarriage, ectopic pregnancy, elective termination, stillbirth, neonatal death and overall perinatal death), transfer to intensive care unit, small for gestational age newborns, other perinatal outcomes of liveborn infants (bronchopulmonary dysplasia, Grade III or IV Intraventricular hemorrhage, cystic periventricular leukomalacia, stage 3 or 4 retinopathy of prematurity, necrotizing enterocolitis, hypoxic-ischemic encephalopathy, and sepsis.
Description: Technical Summary
The primary objective of this study is to determine whether obstetric acute renal failure rates rose in the United Kingdom following a series of confidential enquiries into maternal deaths reports recommending improvements in pre-eclampsia treatment. A secondary objective is to determine whether these recommendations achieved their objective of reducing the rates of pulmonary oedema and improving other maternal and infant health outcomes among women with pre-eclampsia and other hypertensive disorders of pregnancy. To achieve these objectives, we will conduct an interrupted time series study of pregnant women using retrospective data between April 1, 1998 and March 31, 2015. We hypothesize that following the confidential enquiry reports, pre-eclampsia treatment intensity increased, pulmonary oedema and other maternal and perinatal complications decreased among women with hypertensive disorders of pregnancy, and rates of acute renal failure increased.
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Use of hormone replacement therapy and risk of breast cancer — Yana Vinogradova ...
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Use of hormone replacement therapy and risk of breast cancer
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-16
Organisations:
Yana Vinogradova - Chief Investigator - University of Nottingham
Yana Vinogradova - Corresponding Applicant - University of Nottingham
Carol Coupland - Collaborator - University of Nottingham
Julia Hippisley-Cox - Collaborator - University of OxfordOutcomes:
Incidence of breast cancer.
Description: Technical Summary
Objective: The study will investigate risks of incident breast cancer associated with different types of hormone replacement therapy (HRT). Methods: This will be a nested case-control study. Cases will be women with incident breast cancer diagnosed between 1990 and 2016, matched with up to 5 controls by age, sex, practice and calendar year. Cases will be determined using GP, ONS mortality and HES data. Analysis: Exposure to different HRTs will be defined as at least one prescription for that HRT excluding the year before the index date (date of diagnosis of breast cancer or equivalent date in matched controls). Conditional logistic regression will be used to assess the risks associated with different types of oestrogen and progesterone. The effects of duration, length of any gap since the last use and different application routes will be analysed for the most common types of hormones.
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Derivation and validation of statistical models to forecast acute death and longer term survival in people with cirrhosis — Craig Currie ...
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Derivation and validation of statistical models to forecast acute death and longer term survival in people with cirrhosis
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-23
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patients with cirrhosis will be sampled from the CPRD clinical and referral tables by Read code, and from HES data using ICD-10 codes. Mortality will be ascertained from presence of death date in the CPRD patient table.
Description: Technical Summary
We aim to model mortality in patients with cirrhosis while adjusting for a number of contributing factors. From a population of research-quality patients in CPRD eligible for linkage to HES data, we will identify patients with cirrhosis using Read and ICD-10 diagnostic codes. Admissions indicating decompensating events will be identified from HES using ICD-10 codes. In order to model mortality in cirrhosis patients, two statistical models will be created, a logistic regression and a time-dependent survival model. The logistic regression will predict death within three months of diagnosis of cirrhosis while adjusting for a number of laboratory results and prior events (including events that would indicate failure or deterioration of bodily organs). A time-dependent model will be run for patients that survived more than three months adjusting for laboratory results and cumulative admissions for decompensating events on a monthly basis.
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A population-based assessment of the cardiovascular effects of 5-alpha reductase inhibitors — Samy Suissa ...
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A population-based assessment of the cardiovascular effects of 5-alpha reductase inhibitors
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Henok Tadesse Ayele - Collaborator - Merck Sharp & Dohme Corp
Josselin Cabaussel - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Olli Saarela - Collaborator - University of Toronto
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Serge Benayoun - Collaborator - Maisonneuve-Rosemont HospitalOutcomes:
Heart failure; Myocardial infarction; Stroke; Death from cardiovascular causes; Composite endpoint of cardiac failure.
Description: Technical Summary
5ARIs are used for the treatment of BPH. They reduce prostate size by lowering levels of dihydrotestosterone, an androgen which promotes prostate growth. Studies in basic science and epidemiology have repeatedly associated decreased androgen levels with adverse effects on cardiovascular disease and markers for cardiovascular risk; however, the cardiovascular effects of 5ARIs have not been well-researched. Data on this topic derive predominately from clinical trials and their meta-analyses, which are limited by imprecise effect estimates and poor generalisability. We will thus conduct a population-based retrospective cohort study using the CPRD (linked with the HES and ONS) to investigate the cardiovascular effects of 5ARIs. We will study all patients with BPH in the CPRD from April 1998 to March 2016 and classify them into mutually-exclusive, time-dependent exposure categories: users of 5ARIs, users of alpha-blockers (alternative therapies for BPH), and non-users of BPH medications. BPH patients will be followed from diagnosis until hospitalization for heart failure or censoring. Secondary outcomes will include myocardial infarction, stroke, cardiovascular mortality, and a composite cardiac failure endpoint. The effects of 5ARI use versus non-use (primary comparator) or alpha-blocker use (secondary comparator) will be estimated using marginal structural Cox models adjusted for high-dimensional propensity scores.
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The role of statins in the survival of total arthroplasty of the hip and knee. — Tim Board ...
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The role of statins in the survival of total arthroplasty of the hip and knee.
Datasets:GP data, Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-10
Organisations:
Tim Board - Chief Investigator - University of Manchester
Michael Cook - Corresponding Applicant - University of Manchester
Antony Sorial - Collaborator - Salford Royal Hospital NHS Foundation
Terence O'Neill - Collaborator - University of ManchesterOutcomes:
The outcome is revision of primary THA/TKA. Patients who have undergone revision surgery will be included in the study based on READ/OXMIS codes.
Description: Technical Summary
Research suggests that statin exposure may reduce the risk of revision surgery in patients who have undergone THA/TKA by reducing periprosthetic osteolysis through inhibiting osteoclast formation and reducing inflammation around the joint, through attenuating the production of pro-inflammatory cytokines. Using data from a large prescription database in Denmark in a nested case control study design, researchers found that statin therapy was associated with a reduction in the relative risk of revision arthroplasty among those who had a hip replacement. More recently, a study using data from CPRD confirmed that statin use was associated with a small decreased risk of revision surgery. However, in neither study did the authors consider the timing of statin exposure relative to the hip/knee replacement surgery, which may be important in determining outcome because statins are thought to influence osseointegration, which occurs early in the postoperative phase (usually in the three months following arthroplasty), and also osteolysis, which occurs much later (>5 years after primary surgery). They did not look also at whether the type of implant (cemented / uncemented) influenced outcome; this is potentially important as the mechanism of fixation in the femur occurs through different mechanisms in cemented and uncemented prostheses. The proposed study aims to look at whether statin exposure during key postoperative periods influences the risk of revision surgery and also whether there is any influence of the type of implant (cemented / uncemented) on outcome. Inclusion/exclusion criteria: patients with a code for primary THA or TKA recorded in CPRD from 1997 to the date of data extraction will be included in the study. Patients who are aged <40 years, have a history of hip fracture, or have a diagnosis of inflammatory arthritis, at the time of the primary surgery will be excluded. Exposure: Any statin prescriptions. Exposure specifically in the following periods: 3 months before primary surgery to 12 months after primary surgery, 12 months to 5 years after primary surgery, and >5 years following surgery. Outcome: Revision of THA/TKA, identified from primary care records. Statistical analysis: Logistic regression and Cox regression will be used to determine the hazard ratio of revision in the exposed compared to unexposed. In the time-to revision Cox model, the index date will be the date of primary THA/TKA. Participants will be censored at the time of revision surgery, death, date at which their GP practice stops contributing data to CPRD, or the end of the study period (date of data extraction). Propensity score matching will be used to address potential confounding by indication.
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RAASi use patterns following incident hyperkalemia in England — Robert LoCasale ...
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RAASi use patterns following incident hyperkalemia in England
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-23
Organisations:
Robert LoCasale - Chief Investigator - Astra Zeneca Inc - USA
Laura Horne - Corresponding Applicant - Astra Zeneca Inc - USA
Akhtar Ashfaq - Collaborator - Astra Zeneca Inc - USA
Qin Lei - Collaborator - Astra Zeneca Inc - USA
Robin Mukherjee - Collaborator - Astra Zeneca Inc - USA
Sharon MacLachlan - Collaborator - Evidera, IncOutcomes: none known
Description: Technical Summary
The first objective of this study is to describe RAASi use patterns following incident HPK event. All patients with incident HPK between 2009 and 2013 will be identified and those with concomitant RAASi use at the time of HPK will be included in this study. Patients will be classified following HPK by their next prescription for RAASi treatment, which will include: 1. continue at the same dose, 2. dose increase (same drug), 3. dose decrease (same drug), 4. change RAASi, 5. discontinue RAASi, or 6. augment with additional treatment for hyperkalemia. The second primary objective is to quantify the rate of important clinical events following incident hyperkalemia, stratified by the six defined sub-groups.
This study will utilize the Clinical Practice Research Datalink (CPRD) database linked to the Hospital Episodes Statistics (HES) database. Cases of HPK with concomitant RAASi use at the time of HPK will be identified. For continuous variables, the number of observations, mean, standard deviation, median, interquartile range, and range will be presented; for categorical variables, the number and percentages of patients in each category will be presented. Event rates and 95% CIs for clinical outcomes of interest will be reported as both incidence risks and observation time-adjusted incidence rates.
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Clinical burden of illness and healthcare resource utilisation among COPD patients stratified by their moderate-severe exacerbation frequency, inhaled triple maintenance treatment status and blood eosinophil levels — Hana Mullerova ...
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Clinical burden of illness and healthcare resource utilisation among COPD patients stratified by their moderate-severe exacerbation frequency, inhaled triple maintenance treatment status and blood eosinophil levels
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-26
Organisations:
Hana Mullerova - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Wilhelmine Meeraus - Corresponding Applicant - GlaxoSmithKline - UK
Joe Maskell - Collaborator - Amgen LtdOutcomes:
The following clinical burden of illness outcomes will be assessed using all available patient follow-up after the index date. - Rate of AECOPD expressed as the number of AECOPD per 1,000 person-years of follow-up. All exacerbations occurring during following will be included in the numerator, while the denominator will include all follow-up time after the index date. Exacerbations will be defined using validated algorithms described earlier (Rothnie, 2015; Rothnie, 2016). We will report AECOPD in the following groups: moderate, severe, and 'moderate or severe'. - Rate of all-cause mortality, where deaths are defined using the date of death as recorded in CPRD-GOLD. The rate will be expressed as the number of deaths per 1,000 person-years at risk, where follow-up time for the denominator will end on the date of death. The following healthcare resource utilization outcomes will be assessed for the sub-population of patients with at least 12 months of follow-up after their index date. Rates of outcomes are calculated using a numerator that includes all consultations/hospitalisations occurring within the 12 month period after the index date. The denominator for all rates will be the number of patients. - Annual rate of primary-care consultations, expressed per 1,000 patients. All the non-administrative, primary-care consultations, occurring on separate days will be captured in the numerator for this outcome. An algorithm will classify primary-care consultations as GP consultations or nurse consultations using the 'staffrole' and 'constype' variables in CPRD-GOLD. -Annual rate of non-COPD-related, unplanned and unscheduled hospitalisations, expressed per 1,000 patients. Hospitalisations will be identified using HES-APC data. The numerator will include all unplanned admissions in the 12 months after the index date where the primary reason for admission is not for COPD and is not related to an AECOPD by other definitions of severe exacerbations. Each new spell will be considered as a new admission. Episodes within a spell will not be considered as new hospitalisations. The admimeth flag will be used to identify unplanned/unscheduled admissions (values 21, 22, 23, 24, and 28).
Description: Technical Summary
This retrospective cohort study aims to generate evidence needed to better understand severe COPD patients who could benefit from therapies which reduce eosinophils such as mepolizumab. Treatment eligibility will be considered in COPD-diagnosed patients who meet all the following criteria: history of moderate or severe exacerbations of COPD; treatment with inhaled triple maintenance therapy for COPD; and, raised peripheral blood eosinophil levels (>150cells/µL). Ascertainment of eligibility will take place on the date of first valid eosinophil test recorded between 2010-2014 (the index date). Using CPRD-GOLD data linked with HES-APC data, we will describe demographic and clinical characteristics of eligible and non-eligible patients [Objective 1]. We will then estimate rates for eligible and non-eligible patients of clinical burden of illness and healthcare resource utilisation outcomes in the period after the index date [Objective 2]. Outcomes include: moderate/severe exacerbations, all-cause mortality, primary-care consultations and unplanned, non-COPD-related hospitalisations. Finally, we will compare rates of outcomes in eligible and non-eligible patients using multivariable regression modelling (Poisson, Cox or negative binomial, as appropriate) [Objective 3]. In further stratified analyses we will limit our study population to three subsets of patients meeting the exacerbation, inhaled triple therapy, and raised eosinophil level criteria.
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Utilising electronic health records to investigate the association of liver function tests with incidence and outcomes of gastrointestinal disease and malignancy — Harry Hemingway ...
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Utilising electronic health records to investigate the association of liver function tests with incidence and outcomes of gastrointestinal disease and malignancy
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-23
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Constantinos Parisinos - Corresponding Applicant - University College London ( UCL )
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
Liver function tests (LFTs) are commonly performed in clinical practice and are often associated with malignant and inflammatory diseases. Bilirubin, a natural anti-oxidant, is inversely associated with lung and colorectal cancer, chronic obstructive airway disease (COPD), and atherosclerosis. Other liver enzymes (e.g. GGT, ALT, AST) have been associated with inflammatory disorders such as fatty liver disease and hepatobiliary malignancy.
We will use linked primary care, hospitalisation, disease registry and mortality data in England (the CALIBER programme), [1] to investigate associations of LFTs with all common gastrointestinal disease and malignancies. We include people aged 18 or older with no underlying gastrointestinal disease at baseline, and use Cox models to estimate cause-specific hazard ratios (HRs) for the association of LFTs (Bilirubin, ALT, AST, GGT, ALP) with the first occurrence of gastrointestinal malignant and inflammatory disease. We will further compare outcomes of gastrointestinal malignant disease including mortality, disease free survival after curative and non-curative treatment.
Incidence, progression, and recurrence of 5 most common extra-intestinal cancers and death (all causes) will be important secondary outcome measures.
Identical analysis with toxins metabolised by the liver (lipids, triglycerides) will be performed.
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How do we better understand the current management of patients with Chronic Rhinosinusitis within the National Health Service? — Claire Hopkins ...
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How do we better understand the current management of patients with Chronic Rhinosinusitis within the National Health Service?
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-13
Organisations:
Claire Hopkins - Chief Investigator - Guy's & St Thomas' NHS Foundation Trust
Elizabeth Williamson - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Andrew Hayward - Collaborator - University College London ( UCL )
Anne Schilder - Collaborator - University College London ( UCL )
Carl Philpott - Collaborator - University of East Anglia
Caroline Clarke - Collaborator - University College London ( UCL )
Helen Blackshaw - Collaborator - University College London ( UCL )
James Carpenter - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Paul Little - Collaborator - University of Southampton
Spiros Denaxas - Collaborator - University College London ( UCL )
Stephen Morris - Collaborator - University College London ( UCL )Outcomes:
Long-term measures of health status: GP consultation rate, surgery, prescriptions of antibiotics and steroids and 30-day mortality (all cause, respiratory and cardiac).
Description: Technical Summary
Aims: Establish what treatments they currently receive from GPs and in NHS hospitals, estimating how effective these are in terms of further healthcare visits and treatments and how much they cost, to inform future trial design and improve patient pathways.
1. Current management analysis: Linked national Electronic Health Records (EHR) data will be used to map current care pathways and estimate the effectiveness of medical and surgical interventions, determine referral patterns and quantify rates of primary care consultation, hospitalisation, prescriptions (particularly antibiotic and steroid use) and surgical intervention. The denominator for all rates calculated will be person-time at risk and Poisson regression will be used to calculate confidence intervals.
2. Health economic analysis: Cost-effectiveness analyses of treatments/pathways identified above will be conducted to inform the trial design and identify deficiencies in anticipated data collection that could be focused upon to design a future trial that will be used to evaluate the clinical and cost-effectiveness of treatment of patients with CRS. The analysis will use decision analytic modelling using outputs from the current management analysis supplemented with data from published studies.This research will help us understand how CRS is recorded, understand the pathways of care as wells as the effectiveness and cost-effectiveness of these pathways.
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Eczema and Dry Skin - Observational Analysis of Patients Prescription Patterns and Healthcare Utilization — Chantal Holy ...
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Eczema and Dry Skin - Observational Analysis of Patients Prescription Patterns and Healthcare Utilization
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2017-01-10
Organisations:
Chantal Holy - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Chantal Holy - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
David Wei - Collaborator - Johnson & Johnson ( JnJ - USA )
George Moncrieff - Collaborator - Bicester Health Centre (GP)
Gill Nelson - Collaborator - Johnson & Johnson ( JnJ - USA )
Rachel Weinstein - Collaborator - Johnson & Johnson ( JnJ - USA )
Simon Rowe - Collaborator - NHSOutcomes:
Outcomes will be established within 24 months of index. GP visits: All visits will be characterized as related to skin disease, or not. Relevant visits will be analysed in terms of frequency, for all patients. Prescription Use: All prescriptions associated with skin condition visits will be identified and grouped based on BNF chapter . All emollients will be identified by brand whenever possible. The frequency of prescriptions and prescription types/names will be analysed separately for both cohorts.
Description: Technical Summary
Study objectives: To evaluate overall prescribing patterns and the frequency of visits and prescriptions (frequency and type) for dry skin/eczema (DS-E) in patients treated with emollients as the first-line therapy at time of first diagnosis of DS-E, compared with patients not treated with emollients. Patients in this study will be followed over 36 continuous months in 5 calendar years, including 12 months prior to the first emollient prescription, and 24 months after for patients with a DS-E diagnosis. Methods: Cohort identification: Research-grade patients with a diagnosis of DS-E in 2008-2012 and at least 12 months of continuous eligibility prior to the first diagnosis are included in the study sample. Patients treated with at least 2 distinct prescriptions for emollients from the day of index up to 6 months of index skin condition diagnosis will be identified ('Emollient Cohort') and when available, the brand of the Emollient will be included as a variable. For patients in the Emollient cohort, the first emollient prescription fill date will be their index date, they will be required to have 12 months continuous eligibility prior to and 24 months following the index date, such that for the 12 months before and 24 months after the index date, there will be complete primary care records and prescriptions. The control group will be patients with no emollient prescription but at least 2 healthcare exposures (visits or non-emollient prescriptions) within 6 months of first diagnosis. Patients will further be matched for age (0-4 years, 5-9 years, 10-18 year, 19-64, and 65+ years) , gender (male, female), prior prescription patterns (prior use of systemic and TCS) and Charlson Comorbidity Index (a general index of health) and history of atopic conditions (asthma, food allergies and allergic rhinitis). A one-to-one match will be conducted using propensity score matching. For patients in the non-emollient cohort, their first prescription fill date, or first diagnosis date if no prescription used, will be the index date. Data analytics: CPRD database is the primary data source for this study. Prescription patterns and cost of care associated with DS-E condition (GP visit cost + cost of prescription medication + cost of referrals (consultant costs)) will be estimated for all patients using published BNF and PSSRU data.
Source
2016 - 12
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Equitable access to smoking cessation therapies for older smokers — Yoav Ben...
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Equitable access to smoking cessation therapies for older smokers
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Yoav Ben-Shlomo - Chief Investigator - University of Bristol
Yoav Ben-Shlomo - Corresponding Applicant - University of Bristol
Kate Walters - Collaborator - University College London ( UCL )
Mira Hidajat - Collaborator - University of Bristol
Philippa Williams - Collaborator - University of BristolOutcomes:
- To examine whether previous findings, that older smokers are less likely to be offered therapies for smoking cessation are replicated in CPRD. Assuming that this is the case, our main aim is to determine whether this may be clinically appropriate as older patients will have more co-morbidity and shorter life expectancy so it may not be felt valuable to try to help them to quit at this stage in their life. In this way we aim to see if smoking cessation therapies are or are not being made available to older people in an equitable fashion. Specific Aims:. - To investigate whether older smokers are as likely as younger smokers to receive referrals and/or prescriptions for smoking cessation therapies; whether types of therapies offered are similar (i.e. pharmacological from the GP, GP advice, referral to a smoking cessation service, or multiple therapies), and whether there are any differences by: a. Gender. b. Area level deprivation. c. Level of co-morbidities. d. Smoking-related diseases (Chronic Obstructive Pulmonary Disease, Cardio-vascular Disease)
Description: Technical Summary
We have completed an analysis of the English Smoking Tool Kit survey and found that older smokers, whilst less nicotine dependent, were less likely to raise smoking with their GPs. Similarly GPs were less likely to refer older smokers to cessation services or provide NRTs. We could not examine whether this may or may not be appropriate given co-morbidities and life expectancy. The main objective of this study is to examine factors associated with the provision and uptake of smoking cessation therapies and to identify if there is inequitable access to these therapies amongst older smokers. We plan to use CPRD data to conduct a cohort study of patients who are smokers at baseline. Exposure will be defined as smoking status of current smoker. We will use competing risk survival analysis to investigate whether age of patients predicts receiving any prescription or referral for smoking cessation therapies (pharmacological, counselling, or multiple therapies) adjusting for potential confounders. We will explore whether there is evidence that therapies were used and whether prescription of smoking cessation therapies led to long term smoking cessation. We will specifically examine whether high levels of co-morbidity and/or limited life expectancy explain older patients are less actively managed.
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Assessing the association between incretin-based drugs and the incidence of colon cancer in patients with type 2 diabetes — Samy Suissa ...
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Assessing the association between incretin-based drugs and the incidence of colon cancer in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-20
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Devin Abrahami - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Michael Pollak - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes:
Incidence of colon cancer in patient with type 2 diabetes.
Description: Technical Summary
The literature offers discrepant findings as to whether the use of incretin-based drugs is associated with colon cancer incidence. There is evidence that the GLP-1 pathway may be involved in the development of colon cancer by promoting gut growth and crypt fission. However, in a post-hoc analysis of the SAVOR-TIMI 53 trial, the use of the DPP-4i, saxaglipitin, was associated with a 49% decreased risk of colon cancer. Further investigation is required to determine the true association. This study will assess this association by assembling a cohort of patients, at least 40 years of age, newly-treated with antidiabetic drugs between January 1, 1988 and March 31, 2015, with follow up until March 31, 2016. The use of incretin based drugs will be modelled as a time-varying variable, where patients will be considered unexposed to incretin-based drugs until one year after the first prescription for latency purposes. Time-dependent Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals of colon cancer associated with the use of incretin-based drugs. Secondary analyses will assess whether the risk varies by class (DPP-4i vs. GLP-1a), according to cumulative duration of use, or according to time since initiation.
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Neuroprotective Effects of Minocycline in Schizophrenia Patients: Retrospective Cohort Studies Using the Clinical Practice Research Datalink — Dave Barlow ...
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Neuroprotective Effects of Minocycline in Schizophrenia Patients: Retrospective Cohort Studies Using the Clinical Practice Research Datalink
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-22
Organisations:
Dave Barlow - Chief Investigator - King's College London (KCL)
Dave Barlow - Corresponding Applicant - King's College London (KCL)
David Taylor - Collaborator - South London & Maudsley NHS Trust
Fiona GAughran - Collaborator - King's College London (KCL)
Louise Howard - Collaborator - King's College London (KCL)
Maria Herrero Zazo - Collaborator - King's College London (KCL)
Ruth Brauer - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
OBJECTIVE: To provide evidence of a possible relationship between treatment with minocycline and a neuroprotective effect against the development of psychosis.
METHODS: A retrospective cohort study is proposed, using anonymized CPRD data. The source population are patients with a diagnosis of acne recorded over the 10-year period between 1991 and 2000. The medical histories are determined for those patients prescribed for a minimum of two months between 1991 and 2000 either (a) oral minocycline (test group) or (b) alternative oral treatment plus/or topical erythromycin or clarithromycin but never minocycline for acne (control group). The incidence of patients diagnosed with psychosis (see codes in Appendix 1, taken to include schizophrenia, schizoaffective disorder or bipolar affective disorder) between 1991 and 2015 are compared in the two cohorts.
DATA ANALYSIS: The CPRD data will be used to determine the incidence rates for development of psychosis in the minocycline-treatment group and in the control group patients. The data will also be used to model the censored time-to-event data for the two patient groups, with consideration of treatment group, age, and gender, etc., as explanatory co-variates. Statistical analyses and modelling of the data will be performed using StatisticaTM 13.0 software.
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Cohort study assessing the association between hormone therapy use in female breast cancer survivors and subsequent risk of cardiovascular diseases in the UK — Krishnan Bhaskaran ...
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Cohort study assessing the association between hormone therapy use in female breast cancer survivors and subsequent risk of cardiovascular diseases in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-21
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Anthony Matthews - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Alexander Lyons - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Susannah Stanway - Collaborator - Royal Marsden HospitalOutcomes:
Primary exposure: - AI vs tamoxifen use Secondary exposure: - Cumulative duration of endocrine therapy use
Description: Technical Summary
The main objective of this study is to investigate whether CVD risks among post-menopausal breast cancer survivors exposed to AIs are different to those patients treated with tamoxifen. We will achieve this by following a cohort of post-menopausal breast cancer survivors in the CPRD prescribed both AIs and tamoxifen, assessing a range CVD outcomes. We will use unadjusted and fully adjusted Cox regression models to estimate hazard ratios (HR) and 95% confidence intervals (CI), comparing the rate of a range of CVD outcomes between patients prescribed AI therapy only, tamoxifen therapy only, or both drug classes. We will also stratify by patients with and without a prior CVD event, assess the effect of the cumulative duration of AI and tamoxifen therapy, and attempt to understand the impact of multiple CVD outcomes.
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Pericarditis diagnosis in the CPRD: a potential early indicator of undetected cancer and marker of subsequent increased cancer risk — Krishnan Bhaskaran ...
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Pericarditis diagnosis in the CPRD: a potential early indicator of undetected cancer and marker of subsequent increased cancer risk
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Kirstine Kobberoe Sogaard - Collaborator - Aarhus University Hospital
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The outcomes of interest will be first occurrence of cancer. We will restrict our analysis to include the cancers with sufficient power to detect a potential association (colon, pancreas, lung, malignant melanoma, breast, prostate, bladder, non-Hodgkin lymphoma, leukaemia, and any cancer combined; see Section G above). The primary outcomes for hypothesis testing will be lung cancer, breast cancer, non-Hodgkin's lymphoma, leukaemia, and "any cancer" (combined). This is because we have stronger reason to expect a priori an increased risk of these cancers in people with acute pericarditis, based on increases in risk seen in previously published data.7,8 The secondary outcomes will the remaining site-specific cancers, namely bladder, colon, pancreas, prostate cancers, and malignant melanoma. We have observed increased risks for all of these but malignant melanoma in a companion study using Danish national registry data (as yet unpublished, revised manuscript under review with Circulation). In the CPRD, cancers will be identified through medical codes from the CPRD medical dictionary related to cancer, which have been mapped to ICD-10 chapter 2 headings for a previous study.
Description: Technical Summary
Pericarditis is a condition with inflammation of the pericardial sac surrounding the heart. Most cases of pericarditis are thought to be caused by infections (viral or bacterial), but the condition can also occur after a heart attack, or in the presence of autoimmune diseases or cancer. In some published case reports, patients admitted to hospital with pericarditis have been found to have undetected cancer. The increased risk of pericarditis related to cancer, may stem from direct growth of cancer cells from nearby structures or spread of cancer cells through the blood stream. Our aim is to investigate whether pericarditis may the first manifestation of some undetected cancers. We will do this by conducting a matched cohort study using primary care data from the Clinical Practice Research Datalink (CPRD); people presenting with pericarditis will be compared with similar people without pericarditis, and followed up for cancer. Cox proportional hazards models will be fitted to quantify the associoation between pericarditis and cancer outcomes. If pericarditis is frequently a first manifestation of cancer, such a finding could have implications about screening for cancer among patients who have developed pericarditis.
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Using Big data Research to tackle antIbiotic resisTance (BRIT) — Tjeerd van Staa ...
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Using Big data Research to tackle antIbiotic resisTance (BRIT)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-09
Organisations:
Tjeerd van Staa - Chief Investigator - University of Manchester
Tjeerd van Staa - Corresponding Applicant - University of Manchester
Anna Molter - Collaborator - Farr Institute of Health Informatics Research
Darren Ashcroft - Collaborator - University of Manchester
George Tilston - Collaborator - University of Manchester
Mengting Ge - Collaborator - University of Manchester
Miguel Angel Gonzalez Belmonte - Collaborator - Farr Institute of Health Informatics Research
Victoria Palin - Collaborator - University of ManchesterOutcomes:
The main objective of this study is to evaluate the drivers for antibiotic prescribing in UK general practices and the short-term outcomes after antibiotic prescribing.. - Our specific aims are:. - Cluster analyses of READ codes in patients with incidental use of antibiotics. - Evaluation of the drivers (patient and practice level) for incidental antibiotic prescribing. - Longitudinal analysis of variability in rates of change of prescribing between practices and development of a predictive model. - Survival analysis of short-term outcomes associated with incidental antibiotic prescribing. - Descriptive analyses of uptake of rapid diagnostics for C-Reactive Protein (CRP)
Description: Technical Summary
Antibiotics are important medicines for treating bacteria and are losing their effectiveness at an increasing rate. The main objective of this study is to evaluate the drivers for antibiotic prescribing and to analyse short-term health outcomes after antibiotic prescribing. We plan to conduct a population-based cohort study, consisting of patients of any age who were prescribed an antibiotic for incidental use during 2000-2016. Incidental antibiotic use is defined as the prescribing of an antibiotic without any antibiotic prescribing in the previous three months.
Traditionally, antibiotic over-prescribing has been analysed by studying a select infectious disease and assessing whether the prescribed antibiotic was the correct type and dose. However, this study will use a different approach. First, a recently developed analytical strategy will be used to identify clusters of diagnostic data (READ codes) associated with antibiotic prescribing. The results of the cluster analysis will be used to match incidental antibiotic users to non-users based on READ codes, age and gender. In this new matched dataset we will evaluate risk factors (medical, socio-economic) for antibiotic prescribing on the patient and practice level using multi-level analyses. In further analyses we will aim to identify factors associated with the variability in the rate of antibiotic prescribing between different general practices by using time-series analysis techniques. Furthermore, we will compare antibiotic users and non-users for the incidence of infection-related hospital admissions in the 30 days after prescription and for antibiotic-related side-effects using survival analysis methods.
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The association between body mass index and acute kidney injury at start and during hospitalisation — Dorothea Nitsch ...
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The association between body mass index and acute kidney injury at start and during hospitalisation
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-09
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nadia Bennett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
The objective of this study is to investigate the association of body mass index (BMI) with acute kidney injury (AKI). The study will investigate a cohort of individuals with BMI recorded in their primary care records and follow them up until they develop AKI during hospitalisation as evidenced by a corresponding ICD-10 code on the hospital record, or until death, or end of registration within CPRD. Analyses will describe the incidence of AKI according to BMI category and by age and sex, with exploration of any dependency of these associations on calendar year (as both BMI recording and AKI awareness has changed over time). Subsequent analyses will adjust for age, sex, ethnicity, alcohol-use, smoking and Index of Multiple Deprivation (IMD). Analyses will not use laboratory data on kidney function as kidney function testing depends on the presence of cardiovascular risk factors which are in turn associated with BMI. Analyses of creatinine data e.g. by restriction to those with data or by adjusting for serum creatinine would therefore introduce bias due to restriction or conditioning on a pathway variable between BMI and AKI. In contrast, hospital admissions with AKI are not affected by this problem.
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Post-authorization Safety Study: Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder in the CPRD — Alejandro Arana Navarro ...
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Post-authorization Safety Study: Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder in the CPRD
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Cancer Registration Data; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-16
Organisations:
Alejandro Arana Navarro - Chief Investigator - RTI Health Solutions
Alejandro Arana Navarro - Corresponding Applicant - RTI Health Solutions
Andrea Margulis - Collaborator - RTI Health Solutions
Billy Franks - Collaborator - Astellas Pharmaceuticals
Christine Bui - Collaborator - RTI Health Solutions
David Martinez - Collaborator - RTI Health Solutions
James Kaye - Collaborator - RTI Health Solutions
Jamie Robinson - Collaborator - Astellas Pharmaceuticals
Jennifer Bartsch - Collaborator - RTI Health Solutions
Jianmin Wang - Collaborator - RTI Health Solutions
Kenneth Rothman - Collaborator - RTI Health Solutions
Kwame Appenteng - Collaborator - Astellas Pharmaceuticals
Lisa McQuay - Collaborator - RTI Health Solutions
Maria Reynolds - Collaborator - RTI Health Solutions
Milbhor D'Silva - Collaborator - Astellas Pharmaceuticals
Ryan Ziemiecki - Collaborator - RTI Health Solutions
Stefan de Vogel - Collaborator - Astellas Pharmaceuticals
Susana Perez-Gutthann - Collaborator - RTI Health Solutions
Willem Jan Atsma - Collaborator - Astellas PharmaceuticalsOutcomes:
The primary aims of the CPRD study are:. - To estimate and compare the incidence of sex-specific composite cancer endpoints (1 for men and 1 for women) among new users of mirabegron and new users of any comparator antimuscarinic medication (as a group) used in the treatment of OAB, stratified into categories of cancers that occur up to 1 year following the start of treatment, and those that occur more than 1 year following the start of treatment. . - To restrict the above analysis to patients aged 65 years and older.. - To estimate and compare the incidence of the 10 individual sex-specific cancers included in the composite cancer endpoints among new users of mirabegron and new users of any comparator antimuscarinic medication, stratified into categories of cancers that occur up to 1 year following the start of treatment, and those that occur more than 1 year following the start of treatment. . For the primary objectives, sensitivity analyses to examine protopathic bias will be conducted by estimating and comparing incidence in post-treatment initiation intervals of 0 to < 6 months, 6 to < 12 months, 12 to < 24 months, and 24 months or more. Several secondary aims will be evaluated for the sex-specific composite outcomes. Specifically, we will:. - Estimate and compare the sex-specific composite outcomes while:. - Stratifying by new user status (i.e., naive new users vs non-naive new users).. - Excluding immunocompromised patients.. - Censoring person-time when a patient switches from antimuscarinic treatment to mirabegron.. - Estimate and compare the effect of cumulative exposure in tertiles of mirabegron cumulative dose relative to tertiles of antimuscarinic cumulative dose and within mirabegron exposure across tertiles of mirabegron cumulative dose.
Description: Technical Summary
This will be a cohort study comparing the incidence of commonly occurring malignant neoplasms among new users of mirabegron and new users of any comparator antimuscarinic medication, as a group, used in the treatment of overactive bladder (OAB).
Incidence rates for sex-specific composite cancer endpoints will be calculated as follows:
- Males: prostate, lung and bronchus, colon and rectum, melanoma of skin, urinary bladder, non-Hodgkin's lymphoma, kidney and renal pelvis, and pancreas.
- Females: breast, lung and bronchus, colon and rectum, melanoma of skin, urinary bladder, non-Hodgkin's lymphoma, kidney and renal pelvis, corpus uteri, and pancreas.
In addition, the incidence of the 10 individual cancers included in the composite endpoints will be estimated within each of the two exposure cohorts. We will compare cancer incidence between mirabegron follow-up time and antimuscarinic follow-up time. For this comparison of neoplasm endpoints, potential confounders will be addressed and the outcomes will be modelled, accounting for differences in follow-up time between the cohorts. Adjustment for potential confounders will be performed by matching on PS to balance cohorts with respect to factors present at or before the time of cohort entry. We will express results as estimated hazard ratios (HRs) of each study outcome comparing mirabegron to the reference antimuscarinic medications.
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Burden of Hyperkalemia among individuals seeking health care services in England — Robert LoCasale ...
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Burden of Hyperkalemia among individuals seeking health care services in England
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Robert LoCasale - Chief Investigator - Astra Zeneca Inc - USA
Laura Horne - Corresponding Applicant - Astra Zeneca Inc - USA
Akhtar Ashfaq - Collaborator - Astra Zeneca Inc - USA
Qin Lei - Collaborator - Astra Zeneca Inc - USA
Robin Mukherjee - Collaborator - Astra Zeneca Inc - USA
Sharon MacLachlan - Collaborator - Evidera, IncOutcomes:
Primary objective: To describe the rate of clinical outcomes (i.e., a subsequent HPK event, heart failure, cardiac arrhythmia, cardiac arrest, declining kidney function, acute kidney injury (AKI), dialysis, all-cause mortality, or hospitalization) in patients with HPK. Rates of outcomes will be evaluated for: 1, the overall HPK population, 2, stratified by severity of HPK, and 3, within important clinical subgroups (i.e., with/without: T2DM, CKD, HF, HTN, RAASi use).. Secondary objectives: 1. To describe the annual incidence of HPK; 2. To describe healthcare resource utilization overall and within important clinical subgroups, following an incident HPK event; 3. To describe the demographic and clinical characteristics associated with incident HPK.
Description: Technical Summary
The primary objective of this study is to describe the rate of clinical outcomes in patients with HPK. Rates of outcomes will be evaluated for: 1, the overall HPK population, 2, stratified by severity of HPK, and 3, within important clinical subgroups. Secondary objectives include: 1, to describe the annual incidence of HPK; 2, To describe healthcare resource utilization following an incident HPK event; 3, To describe the demographic and clinical characteristics associated with incident HPK.
This study will utilize the Clinical Practice Research Datalink (CPRD) database linked to the Hospital Episodes Statistics (HES) database. Cases of HPK will be identified and used to conduct both a cohort analysis as well as a case-control analysis (to specifically understand characteristics associated with incident HPK). For continuous variables, the number of observations, mean, standard deviation, median, interquartile range, and range will be presented; for categorical variables, the number and percentages of patients in each category will be presented. Event rates and 95% CIs for pre-specified clinical outcomes of interest will be reported as both incidence risks and observation time-adjusted incidence rates. Finally, we aim to identify predictors of clinical outcomes of interest, using Cox regression.
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Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting — Daniel Dedman ...
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Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Daniel Dedman - Chief Investigator - CPRD
Daniel Dedman - Corresponding Applicant - CPRD
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.Outcomes:
COPD: defined as the presence of a relevant Read code at any time up to and including the end of their follow-up in the study, AND aged 35year or older at the time of their first diagnosis. See Codelist 3 in the Appendix for a list of COPD Read codes based on a published validation study [Quint 2014]. Patients in the COPD category will be further stratified according to asthma history (yes/no), defined as the presence of a Read coded asthma diagnosis in their primary care record at any time up and including their index prescription date. ⢠Asthma: defined as those who DO NOT meet criteria for inclusion in the COPD diagnosis group AND (a) have an asthma diagnosis recorded any time in their CPRD history up to and including their end of follow-up in the study AND (b) are classified as ânever smokersâ. See Codelist 4 in the Appendix for a list of asthma Read codes. ⢠âOtherâ (neither COPD nor asthma): defined as those patients who do not meet the criteria for either the COPD or asthma groups above. This group will therefore include patients with evidence of possible asthma and/or possible COPD, but who smoke(d) and/or were aged less than 35 years at the time of first COPD record.
Description: Technical Summary
Fluticasone furoate/vilanterol (FF/VI) is a once-daily inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) fixed dose-combination (FDC) medication approved for the treatment of asthma and COPD. It is available in a lower dose (FF/VI 100/25 â numbers indicate dispensed dose of active substance in micrograms), and higher dose (FF/VI 200/25) version. In the 24-month period immediately following the availability of FF/VI in the United Kingdom, a drug utilisation review will be conducted with the following objectives:
1. among new users of FF/VI: describe patient characteristics, and diagnosis groups (asthma, COPD-including an asthma history stratification, other).
2. among new users of other ICS/LABA FDC: describe patient characteristics, and diagnosis groups.
3. among new users of FF/VI only: describe off-label prescribing, including prescription of FF/VI 200/25 formulation in patients with a COPD diagnosis, and FF/VI (any dose) in children <12 years of age.
4. among new users of FF/VI only: describe treatment patterns, and adherence to therapy.
Participants will be patients with a first ever prescription for FF/VI or other ICS/LABA FDC between January 1, 2014 and December 31, 2015, with at least 12 months of up-to-standard (UTS) follow-up prior to their index prescription date.
In a subset of patients eligible for linkage, hospital episode statistics (HES) data will be used to help delineate between moderate and severe asthma and COPD exacerbation history at baseline (index date).
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Association of Polycystic Ovary Syndrome with patient and offspring mental health outcomes: a retrospective, observational study — Aled Rees ...
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Association of Polycystic Ovary Syndrome with patient and offspring mental health outcomes: a retrospective, observational study
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Aled Rees - Chief Investigator - Cardiff University
Aled Rees - Corresponding Applicant - Cardiff University
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
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Description: Technical Summary
The aim of the study is to determine if there is an increased risk of mental health outcomes in patients with polycystic Ovary Syndrome (PCOS). Patients will be identified with a diagnosis of PCOS from the Clinical Practice Research Datalink (CPRD) based on either a primary care diagnosis using the Read code classification or an ICD-10 coding from secondary care Hospital Episodes Statistics. Patients will then be matched by age, body mass index and primary care practice to control subjects with no history of PCOS. Subjects will be linked to offspring using the CPRD family number. Primary outcomes will be the incidence of psychiatric morbidity (depressive disorder, anxiety, bi-polar disorder, attention-deficit hyperactivity disorder and autism spectrum disorder identified from either Read code in the CPRD GOLD dataset or ICD-10 code in the HES inpatient dataset. Secondary outcomes will be the incidence of either attention-deficit hyperactivity disorder or autism spectrum disorder in the children of mothers with PCOS. Rates of progression to each primary outcome will be presented and compared using Cox proportional hazard models (CPHM) adjusting for smoking status, Charlson Index, total number of contacts with the general practitioner in the year prior to the index date, and IMD quintile.
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Prescribing of antidiabetic drug therapy and comparative incidence of outcomes associated with Type 2 Diabetes — Ian Douglas ...
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Prescribing of antidiabetic drug therapy and comparative incidence of outcomes associated with Type 2 Diabetes
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-21
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Samantha Wilkinson - Corresponding Applicant - Roche
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Heide Stirnadel-Farrant - Collaborator - Astra Zeneca Ltd - UK Headquarters
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Renal function decline; Retinopathy; Body Mass Index; Cardiovascular disease; Neuropathy; Blood Pressure; All cause mortality; HbA1c.
Description: Technical Summary
We aim to use CPRD data to investigate patterns of T2DM oral medication use between 2004 and 2016, describing therapy choices at the first point of therapy intensification after first starting treatment with metformin. We will then compare new users of different antidiabetic drugs using Cox regression, adjusting for confounding factors, for the incidence of common outcomes associated with diabetes (renal function decline, mortality, cardiovascular disease, retinopathy, neuropathy, ketoacidosis), and of surrogate endpoints (including changes in HbA1c, blood pressure (BP) and body mass index (BMI)). People using sulphonylureas will be the reference group against which users of other types of oral antidiabetic drug (OAD) will be compared.
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Identification of patients with post-stroke focal spasticity of the upper or lower limb who were treated with botulinum toxin A, and health-economic evaluation of treatment with botulinum toxin A: a cohort study in England — Carlos Martinez ...
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Identification of patients with post-stroke focal spasticity of the upper or lower limb who were treated with botulinum toxin A, and health-economic evaluation of treatment with botulinum toxin A: a cohort study in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-01
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Stephan Rietbrock - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)Outcomes:
The outcomes of interest are HCRU in the year before and in the year following BoNT-A use. Secondary HRCU components are the number of hospital procedures and the use of muscle relaxants, anxiolytics and other medications.
Description: Technical Summary
The study objective is to develop an algorithm to ascertain patients with post-stroke spasticity of the upper or lower limb who are administered Botulinum toxin type A (BoNT-A) and to quantify the healthcare resource utilisation (HCRU) in the year before and the year after their first BoNT-A administration. A cohort of patients with post-stroke spasticity treated with BoNT-A will be defined from the Clinical Practice Research Database (CPRD) and Hospital Episode Statistics (HES). The HRCU outcomes consist of hospitalisations, days in hospital, hospital procedures, GP visits, and prescriptions for muscle relaxants, anxiolytics and other medications. The rate of HCRU use will be calculated by dividing the number of HRCU events by the total person-time of observation in the 12 months before and the 12 months after the first BoNT-A injection using the period prior to BoNT-A injection as the reference. Wald-tests from conditional Poisson regression models will be used for each HCRU measure separately.
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Assessment of the Risk of Hypertension and Cardiovascular Disease In Women with a History of Pregnancy Complications. — Samy Suissa ...
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Assessment of the Risk of Hypertension and Cardiovascular Disease In Women with a History of Pregnancy Complications.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Samy Suissa - Chief Investigator - McGill University
Graeme Smith - Collaborator - Queen's University Belfast
Jennifer Hutcheon - Collaborator - University Of British Columbia
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Sonia Grandi - Collaborator - University of TorontoOutcomes:
The primary outcome of incident CVD will be defined as, cerebrovascular disease, coronary artery disease, coronary revascularization, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke. For objectives 1, 3, 4, and 5, incident CVD will be defined using Read codes in the CPRD and ICD-10 codes in HES. For all objectives, the date of diagnosis in the database (for CPRD-defined events) or the date of hospital admission (for HES-defined events) will define the event date. The secondary outcome of newly diagnosed hypertension will be defined as a composite of a new diagnosis of hypertension or a new use of an anti-hypertensive drug (including angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, beta-blocker, calcium channel blockers, and diuretics). The date of diagnosis or prescription that first meets the event definition will define the event date. Similar to the primary outcome, Read codes will be used to identify diagnoses in the CPRD and ICD-10 codes from HES. Only outcomes that occur in the post-partum period will be considered.
Description: Technical Summary
Although previous studies have shown an association between HDP and later CVD, the tools currently used by clinicians to predict a women's long-term risk of CVD do not account for complications in pregnancy such as HDP. Given the increasing rates of HDP and the limitations of previous risk prediction tools, there is a need to develop risk prediction models accounting for complications of pregnancy. Using the CPRD Pregnancy Register liked to HES, we will develop risk prediction models using a cohort of women between the ages of 15-45 with a first recorded delivery from April 1st, 1999 to March 31st, 2016. Deliveries will be identified using Read codes in the CPRD and ICD-10 codes in HES. The date of cohort entry will be defined as 42 days after the delivery date. Women will be followed until an event (incident hypertension or cardiovascular disease or censoring due to end of CPRD registration, last data collection, or end of the study period, whichever occurs first. Prediction models will be developed using a Cox proportional hazards model with time since cohort entry as the time axis.
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Understanding the diagnostic pathway for brain tumours in adults and its potential impact on clinical care and outcomes — Yoav Ben...
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Understanding the diagnostic pathway for brain tumours in adults and its potential impact on clinical care and outcomes
Datasets:GP data, HES Accident and Emergency; HES Accident and Emergency; HES Admitted Patient Care; HES Admitted Patient Care; NCRAS Cancer Registration Data; NCRAS Cancer Registration Data; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Yoav Ben-Shlomo - Chief Investigator - University of Bristol
Yoav Ben-Shlomo - Corresponding Applicant - University of Bristol
Edna Keeney - Collaborator - University of Bristol
Michael Poon - Collaborator - University of Edinburgh
Mio Ozawa - Collaborator - University of Bristol
William Hamilton - Collaborator - University of Exeter
William Hollingworth - Collaborator - University of BristolOutcomes:
(a) time until first hospital hospital admission (b) time until major intervention (e.g. surgery, radiotherapy, other (c) time until death or censoring
Description: Technical Summary
Delays in cancer diagnosis cause anxiety for patients and their family and may influence management and prognosis. The presenting symptoms of a brain tumour can be broadly divided into two groups. Firstly, non-specific symptoms e.g. headache and behavioural change. Secondly, specific focal neurological symptoms e.g. hemiparesis or seizures. Patients with non-specific symptoms may wait weeks before presenting to primary care and then for referral. Tumour growth during this period may limit the extent of surgical resection, which correlates with poor outcome. Our aim is to describe how patterns of primary care consultation and symptoms as well as socio-demographic factors relate to diagnosis, referral, hospital management and mortality. We will determine the predictive value of a combination of symptoms and socio-demographic factors ('red flags') to aid GPs in appropriate referral of patients for further investigation. We will compare the impact of GP delay in referral on clinical care in terms of surgery, radiotherapy, chemotherapy and subsequent repeat hospital admissions and mortality risk. Our descriptive findings will also contribute to a separate health economic modelling project estimating the costs and outcomes of different imaging and referral pathways.
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A data-driven approach for identifying falls subgroups through semantic similarity analysis — Andy Brass ...
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A data-driven approach for identifying falls subgroups through semantic similarity analysis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-20
Organisations:
Andy Brass - Chief Investigator - University of Manchester
Andy Brass - Corresponding Applicant - University of Manchester
Chris Todd - Collaborator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
John Ainsworth - Collaborator - University of Manchester
Muhannad Almohaimeed - Collaborator - University of Manchester
Thamer Ba-Dhfari - Collaborator - University of Manchester
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
GP records of fall as recorded via Read codes.
Description: Technical Summary
The objective of this study is to determine how to find good hypotheses from large health datasets. Our primary question is, how should we let the data guide us to find good questions? How do we use the data to learn what good questions to ask the data? Traditionally, population-based studies are used to ask whether there is a support for particular hypotheses. Instead, can we use CPRD data to identify what the good questions are? We are exploring a new strategy for diagnostic hypotheses formulation to analyse medical data. We plan to map CPRD data into a low dimensional space using semantic similarity analysis to provide a good representation of the data, in which visualisation and clustering are much easier. Then classic data mining techniques can be used in order to generate hypotheses that can be used to understand what the factors are that lead to falls and what those that are the conditions caused by falls? Falls provide a particularly rich data set for this study. It is a diagnosis that is relatively common in a population that has significant contact with general practitioners (older people), making it a suitable case study to test the methodology.
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Alternative methods to account for patients with a prior history of treatment in comparative effectiveness studies: an illustration with insulin glargine and breast cancer — Samy Suissa ...
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Alternative methods to account for patients with a prior history of treatment in comparative effectiveness studies: an illustration with insulin glargine and breast cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Jennifer Wu - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill UniversityOutcomes:
For both the pseudo-matching and time-dependent approach, we will assess the effect of insulin glargine on breast cancer. First, primary diagnosis of breast cancer will be defined by Read codes. Breast neoplasms will be classified by Read codes starting with 'B'.
Description: Technical Summary
Currently, there are concerns of prevalent user bias in comparative effectiveness studies but current methods to mitigate this bias have limitations. Therefore, the purpose of the study is to explore alternative study design and analytical techniques to account for patients with a prior history of treatment in a comparative effectiveness study of insulin glargine and breast cancer incidence. A cohort of women 40 years or older with at least one prescription for any insulin from 1988-2012 will be created, with follow-up until February 28, 2015. Two approaches, which will account for women with a prior history of insulin use, will be compared. First, a pseudo-matching approach will be conducted by randomly selecting prescription dates among prior Neutral Protamine Hagedorn (NPH) insulin users (comparator). Second, a time-dependent approach will be used where women are considered unexposed until the first insulin glargine prescription and exposed until end of follow-up. We will compare insulin glargine with NPH because these two insulins are recommended by NICE guidelines as last line treatment options for patients with type 2 diabetes. The Cox proportional hazards model will be used to estimate the adjusted hazard ratios and 95% confidence intervals for each of the approaches.
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Development and validation of risk prediction equations and the burden of Hyperkalemia: a retrospective cohort study using routinely collected clinical practice data — Phil McEwan ...
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Development and validation of risk prediction equations and the burden of Hyperkalemia: a retrospective cohort study using routinely collected clinical practice data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Phil McEwan - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Phil McEwan - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Jason Gordon - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Marc Evans - Collaborator - Llandough Hospital
Qin Lei - Collaborator - Astra Zeneca Inc - USA
Susan S Grandy - Collaborator - Astra Zeneca Inc - USAOutcomes:
Hyperkalemia is a serious medical condition that is associated with increased risk of death and hospitalization. The risk of cardiac-related morbidity and mortality is especially elevated, as hyperkalemia can cause severe alterations to cardiac electrophysiology. In the European context, the natural history and burden of hyperkalemia from the perspective of routine clinical data is not well characterized and studies are largely from the US. Given the relative paucity of European data, and opportunity to utilize US based research that describes the real-world outcomes in patients with/without hyperkalemia, the specific objectives of this research are to utilize routine CPRD and secondary care (HES) data to characterize the natural history and burden of hyperkalemia in the UK, in patients with CKD or HF, with/without diabetes. We also seek to evaluate the validity and generalizability of existing published risk equations when applied to European data, and to develop, where feasible, UK-specific risk equations that relate clinical and demographic factors (including serum potassium) to the risk of morbidity, mortality and hospitalization associated with hyperkalemia.
Description: Technical Summary
Hyperkalemia is a serious medical condition that is associated with increased risk of death and hospitalization. The risk of cardiac-related morbidity and mortality is especially elevated, as hyperkalemia can cause severe alterations to cardiac electrophysiology.
In the European context, the natural history and burden of hyperkalemia from the perspective of routine clinical data is not well characterized and studies are largely from the US. Given the relative paucity of European data, and opportunity to utilize US based research that describes the real-world outcomes in patients with/without hyperkalemia, the specific objectives of this research are to utilize routine CPRD and secondary care (HES) data to characterize the natural history and burden of hyperkalemia in the UK, in patients with CKD or HF, with/without diabetes.
We also seek to evaluate the validity and generalizability of existing published risk equations when applied to European data, and to develop, where feasible, UK-specific risk equations that relate clinical and demographic factors (including serum potassium) to the risk of morbidity, mortality and hospitalization associated with hyperkalemia.
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Patterns of LDL-C lowering by Statins and their association with Cardiovascular Outcomes in the General Population — Folkert Asselbergs ...
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Patterns of LDL-C lowering by Statins and their association with Cardiovascular Outcomes in the General Population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation; MINAP; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Folkert Asselbergs - Chief Investigator - University College London ( UCL )
Kenan Direk - Corresponding Applicant - University College London ( UCL )
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Riyaz Patel - Collaborator - Barts Health and UCLH NHS Trusts
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
1. LDL-C plasma or serum 2. Cardiovascular events including death: - Hypertension - Stable angina - Unstable angina - Myocardial infarction - Cerebral haemorrhage - Haemorrhagic stroke - Ischaemic stroke - Heart failure - Peripheral aortic disease - Transient ischemic attack - Abdominal aortic aneurysm 3. All-cause mortality
Description: Technical Summary
Objectives
The main objective of this study is to determine the extent and impact of variation in statin treatment regimens on LDL-C and cardiovascular events on a national scale using linked electronic health records.Methods
A retrospective longitudinal cohort study of statin usage and clinically relevant endpoints between 1997 and 2016 will be used to (1) match patients groups used in clinical trials to replicate statin dose-response characteristics; (2) extend this group to a more generalizable population at risk of CVD to understand how they are managed and respond in clinical practice.Data analysis
Subjects will be selected based on their likeness to clinical trial participants at both individual and all trial levels. Statin persistence will be assessed through repeated prescriptions and LDL-C measurements. Comparative effectiveness between patient treatment strategies will be evaluated by identifying major pathways given patient indications and observance of the time-appropriate national guidelines.
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The risk of hypomagnesemia and electrolyte disturbances associated with the use of long-term proton pump Inhibitor: a population-based cohort study. — Timothy Card ...
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The risk of hypomagnesemia and electrolyte disturbances associated with the use of long-term proton pump Inhibitor: a population-based cohort study.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-12
Organisations:
Timothy Card - Chief Investigator - University of Nottingham
Fatmah Othman - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of NottinghamOutcomes:
- To investigate the prevalence of hypomagnesemia in patients prescribed long-term PPIs.. - To determine whether patients who have been prescribed long-term PPIs are at an increased risk of hypomagnesemia compared to patients who are not prescribed PPIs. . - To determine whether PPIs induce an increased risk of hyponatremia, hypokalaemia and hypocalcaemia in patients who have prescribed long-term PPI.
Description: Technical Summary
We will conduct a population-based cohort study to examine the association between long-term PPI use and risk of hypomagnesemia in the general population. We will extract all patients within CPRD who had been continually prescribed a PPI over a period of 12 months between 1990 and 2013. These exposed patients will be matched to non-PPI users in term of age, gender, and general practice. Hypomagnesemia will be the primary outcome in this study defined as a READ codes from the linked clinical file or a laboratory serum magnesium test result lower than 0.75 mmol/l. To check the influence of the use of long-term PPIs on other electrolytes, we will consider hyponatremia, hypokalaemia and hypocalcaemia as secondary outcomes. Cox proportional hazard models will be used to estimate crude and adjusted hazard ratios with 95% CI of each outcome (in separate model) associated with the use of long-term PPI compared with controls.
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Diabetes, glycaemic control and risk of infectious disease: cohort and case-crossover studies in primary care — Julia Critchley ...
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Diabetes, glycaemic control and risk of infectious disease: cohort and case-crossover studies in primary care
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Julia Critchley - Chief Investigator - St George's, University of London
Derek Cook - Collaborator - St George's, University of London
Iain Carey - Collaborator - St George's, University of London
Peter Whincup - Collaborator - St George's, University of London
Stephen DeWilde - Collaborator - St George's, University of London
Tess Harris - Collaborator - Polycystic Kidney Disease CharityOutcomes:
Primary outcomes are episodes of infection amongst the cohort, and secondary outcomes are case-fatality and hospitalisation.
Description: Technical Summary
Diabetes has been linked with increased risk of many infections, but studies have mostly been in small or selected populations, sometimes without gold standard definitions of diabetes, or adequate control for confounding. Most have only considered a small number of infections. There is evidence from population based studies that improved glycaemic control is associated with a significantly lower risk or severity of some infections. This is potentially important in guiding targets for diabetes control, particularly among older people with diabetes for whom infections may be frequent and potentially serious, and for whom there is uncertainty regarding the risk to benefit ratio of improved glycaemic control. We plan to obtain data from Clinical Practice Research Datalink (2008-2015); approximately 85,000 prevalent DM patients aged 40 and over annually. We will link to Hospital Episode Statistics to independently identify serious infections requiring hospitalisation. Infections will be identified by Read codes with simultaneous prescribing of an antibiotic, antifungal or antiviral treatment. In a cohort study design, we will use poisson regression to estimate the rate of specific infections among people with diabetes, compared to those without diabetes, and to relate HbA1c levels from 2008-2010 to future infections (2011-2015). We will also use a self-controlled approach (participants act as their own control; 2008-15).
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Prolonged Effects of Assisted reproductive technologies on the health of women and their children: a Record Linkage study for England (PEARL) — Claire Carson ...
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Prolonged Effects of Assisted reproductive technologies on the health of women and their children: a Record Linkage study for England (PEARL)
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Claire Carson - Chief Investigator - University of Oxford
Claire Carson - Corresponding Applicant - University of Oxford
Aden Kwok - Collaborator - Nuffield Department of Population Health
Brooke Hewitson - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Jenny Kurinczuk - Collaborator - University of Oxford
Maria A Quigley - Collaborator - University of Oxford
Oliver Rivero-Arias - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of Oxford
Yangmei Li - Collaborator - University of OxfordOutcomes:
Children's health: Neurological and Developmental outcomes: Autism, developmental delay, special educational needs; Asthma and respiratory health; Congenital anomalies; Childhood illnesses and Infections; CPRD data relating to schooling and behaviour. Mother's health: Mental health - including Postnatal depression; Depression; Anxiety; Long-term Economic costs of ART: Use of health services; Costs associated with subsequent NHS care of women, and their children.
Description: Technical Summary
The PEARL study is an observational epidemiological study using a retrospective cohort design. PEARL links health data (from the Mother-Baby track of CPRD GOLD), to information collected about all assisted reproductive technology (ART) cycles in England (from the Human Fertilisation and Embryology Authority Register). These data will be used to assess the effect of subfertility, ovulation induction and ART on the health and development of children to adolescence, and the wellbeing of infertile mothers. In addition, we will quantify the additional resources, if any, used by women and their children after successful ART. Methodological work to assess the impact of low consent rates after September 2009, on the results of ART studies conducted using the HFEA register, and explore techniques to deal with the effects of the missing data will also be conducted. Mother-baby pairs will be grouped depending on their exposure to ART, based on both primary care and HFEA records, and outcomes will be compared in those children born with and without the use of ART, and their mothers. Multivariable regression analysis will be used, and the role of confounders and effect modifiers in explaining any observed effects between exposure and outcomes will be explored.
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A comparison of the EMPA-REG OUTCOME clinical trial population with T2DM patients treated in the routine clinical practice: An exploratory study using the Clinical Practice Research Datalink (CPRD). — Kamlesh Khunti ...
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A comparison of the EMPA-REG OUTCOME clinical trial population with T2DM patients treated in the routine clinical practice: An exploratory study using the Clinical Practice Research Datalink (CPRD).
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Alicia Gayle - Collaborator - Imperial College London
Andrew Pain - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Chris D Poole - Collaborator - Digital Health Labs Limited
Emaddin Kidher - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Emma Forsyth - Collaborator - Boehringer-Ingelheim - UK
Ilana Gibbons - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
William Henry Fitzgerald Spencer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, IncOutcomes:
The main outcome of the study is the percentage of patients who meet EMPA-REG OUTCOME clinical trial eligibility criteria from the initial T2DM patient cohort.
Description: Technical Summary
The intention of the study is to determine how representative the participants of EMPAREG-OUTCOME RCT are to T2DM patients identified from primary care records. A T2DM patient cohort will be defined in CPRD on which the inclusion and exclusion criteria of the EMPA-REG OUTCOME RCT will be operationalised to define a patient cohort that would be eligible for inclusion in the RCT. This patient subpopulation will be further characterised in terms of clinical and demographic parameters to understand how 'real world' patients matching RCT's eligibility criteria, compare to patients that actually took part in the RCT. As a result, this study can contribute in raising awareness about the generalizability of RCT results and the representativeness of RCT patients. The treatment history of patients who participated in the EMPAREG-OUTCOME RCT has been reported in detail in the supplementary material section of the study report, including history of glucose lowering therapy, anti-hypertensive therapies, lipid lowering therapies and anticoagulants. The proposed study therefore will also describe the treatment history of patients treated in routine clinical practice who meet the main eligibility criteria of the clinical trial.
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An evaluation of the epidemiology and burden of illness of food allergy in the United Kingdom — Craig Currie ...
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An evaluation of the epidemiology and burden of illness of food allergy in the United Kingdom
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-22
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Laura Scott - Corresponding Applicant - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
We aim to evaluate the burden of food allergy in a UK population: comparing healthcare resource use and cost, mortality, and the prevalence of other allergies and atopy in a retrospective matched cohort study, and describing the prevalence of food allergy, causes of death, and associated treatments. Patients with a diagnosis of or positive test for food allergy in CPRD GOLD or HES inpatient data will be grouped into cohorts based on food allergen, and matched 1:1 with two reference groups of non-exposed patients, the first matched on age, sex, practice, year of registration, and linkage status; the second on the same criteria plus atopic status.
Rates and costs of health-service use will be compared using the MannâWhitney U-test. Risk of mortality relative to controls will be compared using a Cox proportional hazards model; a sensitivity analysis will examine deaths from ONS mortality data. Lifetime prevalence of other allergy and atopy will be compared by chi-square test. Annual prevalence rates for food allergy will be presented by age and gender, with the number of research-quality patients registered in CPRD GOLD at each yearâs midpoint as the denominator. Causes of death and prescribed therapies will be tabulated non-comparatively.
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Ethnicity, Cardiovascular Disease and the Risk of dementia — Ioanna Tzoulaki ...
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Ethnicity, Cardiovascular Disease and the Risk of dementia
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Ioanna Tzoulaki - Chief Investigator - Imperial College London
Anita Kulatilake - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Lefkos Middleton - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes:
To estimate the incidence and prevalence of dementia in the CPRD dataset among different ethnic groups, and to examine the interaction between cardiovascular risk factors and ethnicity in relation to risk of dementia.
Description: Technical Summary
This study will be a retrospective longitudinal cohort study. Data on ethnicity and information on CVD risk factors and CVD outcomes will be examined and analysed. Our outcome of interest will include all those participants with a diagnosis of dementia (which will include Vascular dementia, Alzheimerâs disease, Lewy Body dementia, Mixed Dementia and Parkinsonâs Disease dementia) as well as those with probable dementia based on a diagnostic algorithm that will incorporate cognitive test results, blood results and imaging where possible.
We will firstly aim to estimate the prevalence and incidence rates of diagnosed and probable dementia amongst different ethnic groups namely, Asian and Black ethnic minority groups. We will examine data on CVD outcomes and risk factors between these different ethnic groups and compare this with the white Caucasian ethnic group. We will also build regression models to test the association between CVD risk factors and dementia between different ethnic populations. We will use various approaches to correct for confounding including propensity score analysis and examine the representativeness of our sample. A sensitivity analyses will be performed by imputing missing values. Finally, we will aim to validate previously defined risk prediction algorithms for dementia in various ethnic groups. We will use previously published coefficients for each predictor variable and examine baseline recalibration of risk in our population.
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What is the incidence of Developmental Dysplasia of the Hip requiring intervention, and what proportion are diagnosed after six months of age? — Nicholas Clarke ...
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What is the incidence of Developmental Dysplasia of the Hip requiring intervention, and what proportion are diagnosed after six months of age?
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-12-08
Organisations:
Nicholas Clarke - Chief Investigator - University of Southampton
Charlotte Broadhurst - Corresponding Applicant - University of Southampton
Alexander Aarvold - Collaborator - Southampton University Hospitals
Daniel Perry - Collaborator - University of Warwick
Joanna Thomas - Collaborator - Southampton University Hospitals
Tjeerd van Staa - Collaborator - University of ManchesterOutcomes:
Cases will be defined by an entry of a diagnostic code representing 'developmental dysplasia of the hip' within the individual's electronic patient record. The keywords searched were 'hip', 'dysplasia', 'dysplastic', 'dislocated' and 'DDH', 'CDH', 'Pavlik', 'open reduction' and 'closed reduction'. Risk factors (e.g. breech presentation and family history) are known to possibly predict a diagnosis of DDH. However, these patients are all seen in selected screening programmes. Therefore, late presenting cases are more likely to not have these risk factors. Late diagnosed DDH (>6 months) is much more difficult to treat, with higher rates of complications. As a result, it has an increased use of health resources.
Description: Technical Summary
The main objective of this study is to assess the incidence of DDH requiring intervention, as well as in those diagnosed outside of the timescale of the infant screening programme (>6 months gestation). Within CPRD GOLD, patients aged <8years old on the date of entry of a diagnostic code indicative for DDH, will be searched for, after 1st January 1990 and before 1st November 2015. HES will be used to validate this cohort, with the study population restricted to children who are eligible for linkage between CPRD GOLD and HES. Cases with diagnostic codes for neuromuscular disease will be excluded. Cases will also be internally validated. Descriptive analysis will be performed on data in 3 and 6 month bands. Poisson confidence intervals will be calculated and Poisson regression performed to examine trends using Stata 14.0.
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2016 - 11
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A study estimating the occurrence of lower back pain annually in the UK — Jonathan Grant ...
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A study estimating the occurrence of lower back pain annually in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-24
Organisations:
Jonathan Grant - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Alexandra (Alex) Pollitt - Collaborator - King's College London (KCL)
Erin Montague - Collaborator - King's College London (KCL)
Matthew Glover - Collaborator - Brunel University
Stephen Hanney - Collaborator - Brunel University
Susan Guthrie - Collaborator - Rand EuropeOutcomes:
The only measure of interest is the occurrence of new diagnoses of back pain. These will be identified from the appended code list. We will use the CPRD GOLD Define tool to identify new incidences of back pain that were more than 12 months after the start of patients' records. The 'results' file from the Define tool will give use index-dates for each patient. We can merge this data with the Denominator file, and then aggregate the person years and new incidences of back pain by calendar year, gender and five-year age group.
Description: Technical Summary
Data on the incidence of lower back pain (LBP) in the UK is not publicly available. This protocol proposes a simple descriptive study using primary care data from the CPRD database to determine the incidence of lower back pain on an annual basis to determine the proportion of the population receiving research led interventions in the UK. This study will obtain age specific incidence rates on an annual basis (from 1994 to 2013) from the CPRD database. Incidence rates for back pain will be estimated using aggregated counts for new incidences as numerator and person years as denominator. Confidence intervals will be estimated using the binomial distribution (unless working with small values, in which case a partial distribution will be used to estimate the confidence intervals). As indicated above incidence rates will be estimated by gender and five year age group for each year between 1994 and 2013. This study will feed into a wider research study to inform a model of the returns to UK publicly funded musculoskeletal-related research in terms of the net value of improved health outcomes.
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20 year trends for prevalence and incidence of Resistant Hypertension in the United Kingdom and prognosis in adults with hypertension — Sarah...
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20 year trends for prevalence and incidence of Resistant Hypertension in the United Kingdom and prognosis in adults with hypertension
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-07
Organisations:
Sarah-Jo Sinnott - Chief Investigator - Not from an Organisation
Sarah-Jo Sinnott - Corresponding Applicant - Not from an Organisation
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Pavord - Collaborator - University of Oxford
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Primary outcomes: A composite of an individual's first event of myocardial infarction, stroke, or all-cause mortality.. Secondary outcomes: The individual components of the primary outcome, renal failure (defined as progression to chronic kidney disease stage 3, end stage renal disease, dialysis or transplant) and heart failure.
Description: Technical Summary
Using the CPRD-GOLD database, we will identify all the prevalence and incidence of resistant hypertension between 1995 and 2015. We will measure trends for prevalence and incidence, adjusted for age and gender using poisson regression. In addition, we will conduct a prognosis study, comparing the rate of myocardial infarction, stroke, all cause death, heart failure and renal failure in those with resistant hypertension and those without. We will examine the robustness of our definitions and assumptions through various sensitivity analyses.
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The association between patterns of glucocorticoid therapy and risk of developing cataracts and glaucoma in adults. — William Dixon ...
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The association between patterns of glucocorticoid therapy and risk of developing cataracts and glaucoma in adults.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-24
Organisations:
William Dixon - Chief Investigator - University of Manchester
Rachel Black - Corresponding Applicant - University of Manchester
Jamie Sergeant - Collaborator - University of Manchester
Mark Lunt - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
Glucocorticoids (GCs) have had a prominent role in the treatment of inflammatory conditions for over 60 years. They are effective anti-inflammatory agents, but are associated with many potential adverse effects, including cataract and glaucoma. The risk of developing cataract/glaucoma associated with GCs has not been well quantified. The aim of this study is to quantify this risk, in the context of different doses, duration and recency of treatment. The incidence of cataract/glaucoma in 5 different inflammatory conditions (rheumatoid arthritis, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and inflammatory skin disease) will be compared amongst those exposed and unexposed to GCs. Different conventional models of drug exposure will be applied, including âon drugâ, âon drug plus lag window of riskâ (windows of risk are 1 months, 3 months, 6 months and 1 year) and âever exposedâ (1). Dose and time specific models will also be considered including dose on the day of the event, average dose within pre-specified time windows (see above), cumulative dose in pre-specified time windows and the number of years on GCs within the study period. Further, weighted cumulative dose models (2) will also be developed and tested against more conventional models.
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Impact of affluence, atopy and childhood infections on Hodgkinâs Lymphoma incidence in the UK — Andrew Hayward ...
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Impact of affluence, atopy and childhood infections on Hodgkinâs Lymphoma incidence in the UK
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-16
Organisations:
Andrew Hayward - Chief Investigator - University College London ( UCL )
Meenakshi (Meena) Rafiq - Corresponding Applicant - UCL Hospital
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Bethany Wickramsinghe - Collaborator - University College London ( UCL )
Charlotte Warren-Gash - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Sara Thomas - Collaborator - Not from an Organisation
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
A new diagnosis of Hodgkinâs Lymphoma (HL) at any age between 1987-2016. Early HL, defined as a new diagnosis of Hodgkin Lymphoma made before the age of 50 between 1987-2016.
Description: Technical Summary
Hodgkinâs Lymphoma (HL) incidence in the UK has increased by almost 20% in the last decade. The reasons for this increase are unknown. Ecological studies established that variation in age-distribution and frequency of HL worldwide are closely related to a countryâs affluence level, with industrialized countries showing a later peak incidence in older adolescence/young adulthood and significantly higher HL incidence rates. This difference is thought to be attributable to variation in childhood exposure to infection, with children in wealthier countries being exposed to fewer infections at an earlier age, which affects their immune development and subsequent risk of developing certain diseases, including atopic diseases as demonstrated in the hygiene hypothesis.
This study will use general practice data, linked to hospital episode statistics and the National Cancer Registry, to investigate if age-specific HL incidence varies between different socioeconomic groups in the UK and if this has changed over time with changing affluence of the UK population. Using a case-control study design and multivariable logistic regression, odds of prior exposure to childhood infections and atopic diseases will then be compared in individuals with and without HL, matched for age and sex. This will allow determination of risk factors for developing Hodgkinâs Lymphoma.
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Is Hydroxychloroquine associated with decreased mortality among people with Rheumatoid Arthritis — Matthew Grainge ...
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Is Hydroxychloroquine associated with decreased mortality among people with Rheumatoid Arthritis
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-07
Organisations:
Matthew Grainge - Chief Investigator - University of Nottingham
Fiona Pearce - Corresponding Applicant - University of Nottingham
Abhishek Abhishek - Collaborator - University of Nottingham
Hannah Fleet - Collaborator - University of Nottingham
Peter Lanyon - Collaborator - Nottingham University HospitalsOutcomes:
Death (age at death) Cause-specific mortality â i.e. mortality rate due to infection, cardio-vascular disease, cancer, idiopathic pulmonary fibrosis
Description: Technical Summary
Objectives: To compare all-cause and cause-specific mortality between incident cases of Rheumatoid arthritis who are prescribed and who are not prescribed hydroxychloroquine.
Methods: A cohort study using a propensity score adjusted landmark analysis of patients with Rheumatoid arthritis in the Clinical Practice Research Datalink (CPRD). Baseline characteristics and data on medication exposure will be extracted from the CPRD, and data on the outcomes (death, date of death and cause of death) will be extracted from linked ONS mortality data.
Data analysis: A propensity score for the probability of each patient receiving hydroxychloroquine within 12 months after diagnosis will be calculated using logistic regression. Mortality will be compared in the hydroxychloroquine group and non-hydroxychloroquine group using Kaplan-Meier survival and cox proportional hazards analysis, adjusting for the propensity score, and for the confounding effects of statin and anti-platelet prescription. As a sensitivity analysis exposure to hydroxychloroquine will be re-defined as a time-varying covariate.
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An interrupted time series analysis investigating the impact of regulatory advice on nitrofurantoin prescribing in UK primary care. — Katherine Donegan ...
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An interrupted time series analysis investigating the impact of regulatory advice on nitrofurantoin prescribing in UK primary care.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-23
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Tracy Turc-Milloy - Collaborator - MHRAOutcomes:
The objective of this study is to assess the outcome of the MHRAâs Drug Safety Update (DSU) in September 2014 [1]. This drug utilisation study will utilise an interrupted time series study design in a population of patients prescribed nitrofurantoin between 01/05/2011 and 30/04/2016. Analysis will be performed using an ordinary least-squares regression analysis that accounts for autocorrelation. The primary outcome considered will be the trend in incidence rates of nitrofurantoin prescription in UK primary care in the before and after DSU periods. The primary analysis will compare the trends in prescribing before and after the publication of prescribing advice related to nitrofurantoin use in patients with chronic kidney disease. Two sensitivity analyses will be conducted: 1) Including patients with no record for estimated glomerular filtration rate (eGFR) in the highest eGFR category. 2) Varying the time window around the prescribing in which a test result will be eligible from 1 year before to any time.
Description: Technical Summary
The objective of this study is to assess the outcome of the MHRAâs Drug Safety Update (DSU) in September 2014 [1].
This drug utilisation study will utilise an interrupted time series study design in a population of patients prescribed nitrofurantoin between 01/05/2011 and 30/04/2016. Analysis will be performed using an ordinary least-squares regression analysis that accounts for autocorrelation. The primary outcome considered will be the trend in incidence rates of nitrofurantoin prescription in UK primary care in the before and after DSU periods. The primary analysis will compare the trends in prescribing before and after the publication of prescribing advice related to nitrofurantoin use in patients with chronic kidney disease. Two sensitivity analyses will be conducted:
1) Including patients with no record for estimated glomerular filtration rate (eGFR) in the highest eGFR category.
2) Varying the time window around the prescribing in which a test result will be eligible from 1 year before to any time.
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Aromatase Inhibitors and Risk of Colorectal Cancer in Post-menopausal women with breast cancer — Samy Suissa ...
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Aromatase Inhibitors and Risk of Colorectal Cancer in Post-menopausal women with breast cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-24
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Alan Barkun - Collaborator - McGill University
Farzin Khosrow-Khavar - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Nathaniel Bouganim - Collaborator - McGill UniversityOutcomes:
Patients will be considered exposed to AIs or tamoxifen starting one year after the date of the first prescription until the end of follow-up. Lagging exposure by one year will be necessary given the possible diagnostic delays associated with colorectal cancer, to impose a minimum time period between exposure and the incidence of the colorectal cancer (latency), and minimize biases related to reverse causality (a situation where exposure might be initiated or terminated at early signs or symptoms of the outcome).
Description: Technical Summary
A long-term follow-up of a randomized controlled trial (RCT) has indicated that AIs may increase the risk of colorectal cancer in comparison with tamoxifen. To date, this is only RCT that has reported on the incidence of colorectal between aromatase inhibitors and tamoxifen in post-menopausal women with breast cancer. Further, no observational studies have examined this association in clinical practice. Thus, the objective of this study is to use the Clinical Practice Research Datalink to assess whether the use of aromatase inhibitors, when compared with tamoxifen, is associated with an increased risk of colorectal cancer in a cohort of approximately 26,000 patients newly-diagnosed with breast cancer. The use of aromatase inhibitors and tamoxifen will be treated as a time-varying variable, with exposures lagged by one year for latency considerations and to minimize reverse causality. Time-dependent Cox proportional hazards model will be used to estimate adjusted hazard ratios (with 95% confidence intervals) of incident colorectal cancer associated with use of AIs when compared with tamoxifen use. This study will address an important safety question in an older population already at increased risk of colorectal cancer.
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Metformin and the incidence of lymphoid malignancies in patients with type 2 diabetes — Samy Suissa ...
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Metformin and the incidence of lymphoid malignancies in patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-03
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Adi Klil-Drori - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Michael Pollak - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes: none known
Description: Technical Summary
The objective of this study is to examine the risk of lymphoid malignancies with the use of metformin in patients with type 2 diabetes. We will assemble a cohort of patients newly-treated with non-insulin antidiabetic medications between 1998 and 2014 using the Clinical Practice Research Datalink (CPRD) with linkage to the Hospital Episode Statistics (HES), Index of Multiple Deprivation and the Office for National Statistics (ONS). Cohort entry will be defined by the first-ever prescription of an antidiabetic in CPRD. Primary exposure will be defined in a time-dependent fashion as the use of metformin lagged by 1 year, and the reference group will be no use of metformin. We will define the primary outcome as the first hospitalization with a diagnosis of non-Hodgkinâs lymphoma (NHL), Hodgkinâs lymphoma (HL), multiple myeloma (MM), chronic lymphoid leukemia (CLL), or acute lymphoblastic leukemia (ALL), identified in HES by international classification of diseases-10 (ICD-10) codes. Time-dependent Cox models will be used to assess the hazard ratio for the composite of lymphoid malignancies associated with the use of metformin, compared with no use. Secondary analyses will include duration- and dose-response, as well as the outcome stratified by specific malignancies.
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Therapy decisions in newly diagnosed COPD patients in GOLD groups A and B- follow up of patients receiving different therapies. A non-interventional study using the Clinical Practice Research Datalink (CPRD) database. — Chris D Poole ...
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Therapy decisions in newly diagnosed COPD patients in GOLD groups A and B- follow up of patients receiving different therapies. A non-interventional study using the Clinical Practice Research Datalink (CPRD) database.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-24
Organisations:
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Alicia Gayle - Corresponding Applicant - Imperial College London
James Clark-Wright - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Nick Ramscar - Collaborator - Boehringer-Ingelheim Pharmaceuticals, IncOutcomes:
We aim to compare the following disease outcomes: Health Resource Use - (all-cause and COPD related) 1. Average GP visit duration of consultations 2. Number of interactions with a health care professional per month 3. Rate of hospital admissions 4. Rate of SAMA/SABA prescriptions defined using CPRD prescription read codes 5. Rate of referrals
Description: Technical Summary
This study is a non-interventional cohort study using existing data provided by the Clinical Practice Research Datalink (CPRD), to gain detailed insights on the characteristics of COPD patients treated with an Inhaled Corticosteroid (ICS) containing therapy or non-ICS containing therapy. Recent research suggests that many patients appear to be inappropriately prescribed ICS at their initial COPD diagnosis, regardless of lung function severity. The potential effect that this may have on outcomes after diagnosis has yet to be investigated. The main objective of this study is to compare health care resource use between patients prescribed an ICS and non-ICS containing therapy after COPD diagnosis. The results from this study will be used to support the scientific understanding of how choice of therapy may influence COPD outcomes. Comorbidities and demographic information will be described for the groups of patients initiated on different therapies. Multivariate regression models will be used to compare outcomes between the two propensity-matched groups.
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Blood eosinophil count and prospective asthma disease burden — David Price ...
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Blood eosinophil count and prospective asthma disease burden
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-07
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Andrew Menzies-Gow - Collaborator - Royal Brompton Hospital
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Gopalan Gokul - Collaborator - Astra Zeneca Inc - USA
Guy Brusselle - Collaborator - Ghent University Hospital
Janwillem Kocks - Collaborator - University Medical Centre Groningen
Javier Nuevo - Collaborator - Astra Zeneca Inc - USA
Rupert Jones - Collaborator - Plymouth University
Sarang Rastogi - Collaborator - Astra Zeneca Inc - USA
Trung Tran - Collaborator - Astra Zeneca Inc - USAOutcomes:
⢠Asthma exacerbations ⢠Excessive short-acting bronchodilator use ⢠Hospitalisations for asthma ⢠Acute respiratory events
Description: Technical Summary
Objectives:
To study whether:
1. High blood eosinophil counts are associated with subsequent increased asthma exacerbation frequency at all levels of ICS treatment.
2. Patients admitted to hospital with asthma exacerbation are more likely to be re-admitted if their pre-admission eosinophil count is highMethods:
Objective 1: Patients with active asthma (â¥2 drug prescriptions in the baseline year prior to index date (ID)) will be selected from both CPRD and the Optimum Patient Care Research Database.
Objective 2: CPRD patients with HES Admitted Patient Care data will be selected.Objective ID: most recent date of Primary Outcome Outcome Period
1 Eosinophil count recording Number of exacerbations 1 & 3 years
2 First hospital discharge for asthma within 1 year of eosinophil measurement Occurrence of re-admission for asthma 4 & 52 weeksPatients will be characterised and confounders will be assessed during the baseline year. Adjusted associations with 95% confidence intervals will be assessed from multiple regression analyses.
Objective 1: Rate Ratios (RR) by negative binomial regression analysis for patients on low, medium and high dose ICS separately. Analyses will be repeated in patients with good ICS adherence (Medication Possession Ratio â¥80%).
Objective 2: Hazard ratios (HR) by Cox regression analysis.
Source - and 6 more projects — click to show
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Measuring the potential adverse impact of the adoption of prescribing guidelines in primary care — Paul Aylin ...
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Measuring the potential adverse impact of the adoption of prescribing guidelines in primary care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-30
Organisations:
Paul Aylin - Chief Investigator - Imperial College London
Sabine Bou-Antoun - Corresponding Applicant - Imperial College London
Alan Johnson - Collaborator - Public Health England
Alison Holmes - Collaborator - Imperial College London
Benedict Hayhoe - Collaborator - Imperial College London
Ceire Costelloe - Collaborator - Imperial College London
Myriam Gharbi - Collaborator - Imperial College London
Violeta Balinskaite - Collaborator - Imperial College LondonOutcomes:
Outcomes of interest: 1) Antibiotic prescription rate: Have prescribing practices of antibiotics altered? Has there been a reduction in antibiotic prescribing since the introduction of the quality premiums; assessed by identifying variations in: - Proportion of patients prescribed antibiotics for diagnoses of interest - The number of antibiotic items per STAR-PU (specific therapeutic group age-sex weightings related prescribing units). - Stratifying measures above by total or broad-spectrum antibiotics (co-amoxiclav, cephalosporins, quinolones). 2) Incidence of adverse consequences. Primary and secondary care outcomes have been identified using CPRD and ICD-10 codes. a) Incidence in primary care as well as an increase in severity will be assessed; as indicated by hospital admission (for the same or clinically related condition during 60 days following diagnosis) and mortality (60 day-all cause mortality from initial consultation). b) Count of unintended consequences by month (unrelated to primary consultation) 3) Cohort: Odds ratio between exposed (post-QP) and unexposed (pre-QP) group, for RTI, UTI and SSTI.
Description: Technical Summary
Antibiotics differ to other medical drugs, as their overuse and misuse selects resistance and weakens their effectiveness. The threat of antimicrobial resistance has been of growing public health concern, with the apprehension that many common and serious infections will become increasingly difficult to treat, if not entirely untreatable with pan-resistant infections. In response to the increase of antimicrobial resistance, quality premiums were introduced to improve antibiotic prescribing. This change should impact and reduce unnecessary antibiotic exposure, with the intention of easing or slowing the rate of resistance. A reduction in overall antimicrobial prescribing however, may be accompanied with a reduction in appropriate therapy. A delay in treatment where antibiotics are required permits bacteria to propagate and may cause more severe infections or other clinical complications, e.g. bacteraemia, death. This study will analyse linked Clinical Practice Research Database (CPRD), Hospital Episode Statistic (HES) and Office for National Statistics (ONS) data to examine a patient's pathway through the healthcare system and distinguish any adverse outcomes related to the introduction of the quality premiums. Time series analysis will be completed to examine changes in the time trends of prescribing antibiotics and adverse outcomes, prior to and following the intervention (i.e. the Quality premium).
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Investigating the cost effectiveness of alternative oral antiplatelet regimens in patients with type 2 diabetes in England. — Tony Avery ...
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Investigating the cost effectiveness of alternative oral antiplatelet regimens in patients with type 2 diabetes in England.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-14
Organisations:
Tony Avery - Chief Investigator - University of Nottingham
Georgios Gkountouras - Corresponding Applicant - University of Manchester
Li-Chia Chen - Collaborator - University of Manchester
Lukasz Tanajewski - Collaborator - University of Nottingham
Rachel Elliott - Collaborator - University of Manchester
Tony Avery - Collaborator - University of NottinghamOutcomes:
Adherence to antiplatelet medicines: Prescription information as recorded from CPRD will be used to estimate patients' adherence to antiplatelet regimens. All-cause mortality: Information about all-cause mortality will be extracted from the CPRD database, ONS and inpatient HES linked datasets. Cardiovascular disease (CVD) related death: Death event related to cardiovascular disease will be separated from the all-cause mortality information. Non-Fatal stroke: Information about stroke events of any type (ischaemic, haemorrhagic, transient ischaemic attack) that are not fatal will be extracted, with information sourced from ICD-10 codes from HES inpatient data. Major adverse cardiovascular events (MACE): MACE will be the composite outcome of interest in the analysis. Bleeding: Hospitalisation events due to internal bleeding will be obtained from the records of HES inpatient admission data. Regimen switch: The event date when patients are switching treatment groups will be obtained from the therapy files of CPRD. Health care costs and resource use: Information about prescriptions, diagnostic tests and primary care contacts will be obtained from CPRD therapy, clinical, additional, and consultation files respectively, whereas outpatient visits in secondary care, visits to A&E, and hospitalisations will be obtained from HES inpatient and outpatient linked datasets. Resource use in primary care will include information about general practice consultations that will be obtained from the consultation files and the clinical files of CPRD respectively.
Description: Technical Summary
Acute coronary syndromes (ACS) represent a subgroup of ischaemic heart diseases ranging from unstable angina to transmural myocardial infarction. Type 2 diabetes populations (T2DM) are of particular interest as a subgroup of ACS sufferers, because ACS can occur if T2DM is not managed correctly, and ACS is one of the most costly complications of T2DM. Antiplatelet therapy is recommended for the secondary prevention of ACS, with aspirin and clopidogrel being the most commonly prescribed agents. In this study, we aim to identify and investigate the economic impact of different antiplatelet regimens in patients with T2DM post-ACS. Starting from descriptive analyses of the patient population, the variation of outcomes and resource use will be explored and long term costs and health effects of different antiplatelet treatments will be investigated. This will be achieved with the use of time-to-event analysis, cost analysis based on information from Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES), and the use of a decision analytic model which will estimate the mean per patient cost per quality-adjusted-life year gained from the NHS perspective over lifetime.
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Diagnosis and treatment of dementia in primary care in the UK — Katherine Donegan ...
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Diagnosis and treatment of dementia in primary care in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-09
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRAOutcomes:
Number and proportion of patients with a diagnosis of dementia Number and proportion of dementia patients with a prescription for an anti-dementia or antipsychotic medication
Description: Technical Summary
Dementia is a syndrome that is associated with an ongoing decline of the brain and its abilities. Symptoms can include memory loss, language problems, short attention span, misunderstanding, and lack of judgement. There are over 800,000 people in the UK diagnosed with dementia, with this number, and hence the associated cost, expected to increase dramatically as life expectancy increases. Anti-dementia drugs are licensed for the treatment of the symptoms of dementia with an increasing number of cheaper generic formulations becoming available in recent years. In addition, antipsychotic drugs have been used to manage the psychological and behavioural symptoms of dementia in elderly patients although only one, risperidone, is licensed for the treatment of dementia patients. Other antipsychotics are not usually recommended for the treatment of dementia because they are associated with an increased risk of cardiovascular disease and mortality, and can make the symptoms of dementia worse. This study will quantify the level of recorded diagnosis of dementia and the prescribing of both anti-dementia and antipsychotic medications over time. It will also investigate the potential impact of both new guidelines on the diagnosis and treatment of dementia as well as decreasing medication costs. Trends in the use of other medicines that are also used to treat the symptoms of dementia, including antidepressants, hypnotics/anxiolytics, and anticonvulsants, will also be explored. This is a descriptive study only and no formal hypothesis testing will be conducted. The findings will be used to inform the ongoing efforts through the National Dementia Strategy to reduce the level of inappropriate prescribing of antipsychotics to treat dementia.
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Effect of statin therapy in older patients after a first cerebrovascular event or myocardial infarction, a population based cohort study in the CPRD — Anthonius de Boer ...
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Effect of statin therapy in older patients after a first cerebrovascular event or myocardial infarction, a population based cohort study in the CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-14
Organisations:
Anthonius de Boer - Chief Investigator - Utrecht University
Dineke Koek - Collaborator - University Medical Centre Utrecht
Geert Lefeber - Collaborator - University Medical Centre Groningen
Patrick Souverein - Collaborator - Utrecht University
Wilma Knol - Collaborator - University Medical Centre UtrechtOutcomes: none known
Description: Technical Summary
The primary aim is to determine if initiation of statins is effective in preventing recurrence of the composite endpoint of cardiovascular events and cardiovascular mortality in patients aged 75 years and older following a first acute myocardial infarction (AMI) or ischemic cerebrovascular accident (iCVA). The secondary aim is to determine the effect of initiation of statins on the individual components of the primary objectiveâs composite endpoint and all cause mortality. A retrospective cohort study with data extracted from The Clinical Practice Research Datalink (CPRD) will be performed. Patients eligible for participation are those aged 65 and older following hospitalisation for a first AMI or iCVA and not having received a statin for at least one year prior to hospital admission. Data on patients baseline characteristics, statin and concomitant cardiovascular medication use will be gathered. Time-dependent Cox regression models will be used to calculate hazard ratios for cardiovascular events and cardiovascular deaths for statin users compared to nonusers with statin use as the time-dependent variable. Adjusted analysis will be performed using cardiovascular risk factors, baseline characteristics, comorbidity, frailty status and concomitant drug use. Furthermore age, gender, inclusion time-period, primary event and frailty status will be investigated as effect modifiers.
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Gender differences in Chronic Obstructive Pulmonary Disease: baseline characteristics, progression, and exacerbations in the United Kingdom's Clinical Practice Research Datalink — Emil Loefroth ...
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Gender differences in Chronic Obstructive Pulmonary Disease: baseline characteristics, progression, and exacerbations in the United Kingdom's Clinical Practice Research Datalink
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-08
Organisations:
Emil Loefroth - Chief Investigator - NOVARTIS
Valentino Conti - Corresponding Applicant - Not from an Organisation
Andreas Clemens - Collaborator - NOVARTIS
Florian Gutzwiller - Collaborator - University of Basel
Hui Cao - Collaborator - NOVARTIS
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Paul McDwyer - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Robert Fogel - Collaborator - NOVARTISOutcomes:
- Primary: Hazard Ratio of time to first COPD exacerbation between women and men - Secondary: Annual Rate of COPD exacerbation - Secondary: FEV1, FEV1 % predicted, FEV1/FVC, mMRC, and GOLD combined COPD assessment category at baseline - Secondary: Change in FEV1 and mMRC at 1 year, 2 years, and 3 years from baseline
Description: Technical Summary
The objective is to compare women and men with incident COPD diagnosis regarding to the risk of exacerbations, severity of COPD at baseline and during follow-up. Specifically, the primary objective is to compare the hazard ratio of first exacerbation between women and men, and the secondary objectives are to compare the annual rate of exacerbation, the forced expiratory volume in 1 second (FEV1), FEV1 percent predicted, FEV1/FVC (forced vital capacity), the Modified British Medical Research Council Dyspnea Scale (mMRC), and GOLD COPD category at baseline, and FEV1 and mMRC during follow-up. The cohort of incident patients with COPD between 01 January 2010 and 31 December 2015 will be selected among the Clinical Practice Research Datalink (CPRD) subset of patients linking with Hospital Episode Statistics (HES) dataset. Descriptive statistics will be produced to compare women and men's characteristics at baseline; multivariable regression models will be fitted to estimate hazard ratio of first exacerbation, exacerbation rates, and changes in FEV1 and mMRC during follow-up, between women and men.
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Benefits of high dose ICS in patients with asthma and high blood eosinophil counts — David Price ...
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Benefits of high dose ICS in patients with asthma and high blood eosinophil counts
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-11-10
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Andrew Menzies-Gow - Collaborator - Royal Brompton Hospital
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Gopalan Gokul - Collaborator - Astra Zeneca Inc - USA
Guy Brusselle - Collaborator - Ghent University Hospital
Janwillem Kocks - Collaborator - University Medical Centre Groningen
Javier Nuevo - Collaborator - Astra Zeneca Inc - USA
Rupert Jones - Collaborator - Plymouth University
Sarang Rastogi - Collaborator - Astra Zeneca Inc - USA
Trung Tran - Collaborator - Astra Zeneca Inc - USAOutcomes:
⢠Asthma exacerbations ⢠Excessive short-acting bronchodilator use ⢠Hospitalisations for asthma ⢠Acute respiratory events
Description: Technical Summary
Objective: to study the effectiveness of initiating patients with high blood eosinophil counts on high dose ICS to reduce exacerbation risk and to achieve asthma control.
Patients with asthma and high blood eosinophil counts who step-up to high dose ICS will be extracted from the Clinical Practice Research Datalink or the Optimum Patient Care Research Database (date is index date (ID)).
1. Patients who step-up from medium to high dose ICS will be matched to and compared with control patients on stable medium dose treatment during follow-up (Figure).
The ID of control patients will be chosen at exactly the same number of days after the date of blood eosinophil count recording as the matched step-up patient.
2. Patients who step up from low to high dose ICS will be matched to and compared with patients who step up from low to medium dose ICS.Patients will be matched on the following characteristics assessed in the year prior to ID: timing and value of eosinophil count, number of exacerbations, ICS drug and dose, propensity score of high dose ICS assignment.
Survival and negative binomial regression analyses will be used to compare the rates of asthma exacerbations over 1 and 3 years of follow-up.
Source
2016 - 10
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Annual Healthcare Resource Use and Costs for Eczema in Children: A Cost of Illness Study for the English NHS — Tracey Sach ...
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Annual Healthcare Resource Use and Costs for Eczema in Children: A Cost of Illness Study for the English NHS
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-27
Organisations:
Tracey Sach - Chief Investigator - University of East Anglia
Tracey Sach - Corresponding Applicant - University of East Anglia
Emma McManus - Collaborator - University of East Anglia
Katrina Abuabara - Collaborator - University Of California, San Francisco
Kim Thomas - Collaborator - University of Nottingham
Lu Ban - Collaborator - University of Nottingham
Matthew Ridd - Collaborator - University of Bristol
Miriam Santer - Collaborator - University of Southampton
Nick Levell - Collaborator - Norfolk and Norwich University Hospitals
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sonia Gran - Collaborator - University of NottinghamOutcomes:
NHS primary and secondary care resource use and cost during April 2014 to March 2015
Description: Technical Summary
This study will estimate the total annual NHS resource use and costs for children with eczema. This work builds upon the work undertaken as part of ISAC Protocol 16_056 (entitled "Risk of eczema in children: a population-based study"). From HES-linked CPRD, children aged 0-17 years with an incidence of eczema by the end of March 2015 will be identified as cases, and will be 1:1 individually matched to controls based on age, gender, and General practice. All NHS primary and secondary care resource use during April 2014 to March 2015 will be extracted for cases and controls. Resource use will be costed using published unit costs for 2015 in £sterling. Descriptive statistics will describe children's characteristics, resource use and costs. Multivariate regression models for paired data will be used to examine the mean differences (with 95% confidence intervals) in healthcare costs between cases and controls with adjustment for potential confounders including comorbidities. The results will also be stratified by years since diagnosis, age, and comorbidities.
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Clinical effectiveness of combining two drugs versus monotherapy as initial treatment strategy in hypertension - a matched cohort study in CPRD — Karine Marinier ...
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Clinical effectiveness of combining two drugs versus monotherapy as initial treatment strategy in hypertension - a matched cohort study in CPRD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-17
Organisations:
Karine Marinier - Chief Investigator - IRIS - Institut de Recherches Internationales Servier
Karine Marinier - Corresponding Applicant - IRIS - Institut de Recherches Internationales Servier
Giuseppe Mancia - Collaborator - University Milano-Bicocca
Martine De CHAMPVALLINS - Collaborator - Servier Laboratories - UK
Neil Poulter - Collaborator - Imperial College London
Pauline Macouillard - Collaborator - IT&M StatsOutcomes:
Primary outcome. Time to Blood Pressure control Secondary outcomes. Risk of a serious cardiovascular (composite endpoint of acute non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) Time to treatment response
Description: Technical Summary
The main objective of this study is to assess the effectiveness of initiating therapy with two drugs in combination versus monotherapy as the initial drug treatment strategy in hypertension.
Adults with hypertension and initiating antihypertensive drugs, including angiotensin-converting enzyme inhibitors, angiotensin-II receptor blockers, calcium-channel blockers, thiazide and thiazide-like diuretics and beta-blockers, between 2006 and 2014 will be identified and followed until 2015. Patients initiating two drugs in combination (given as fixed or free combination) will be matched (1:4) to those initiated on a single drug using a propensity score built on key baseline characteristics to control for channelling bias.
The primary outcome will be time to blood pressure control while secondary outcomes will include a composite endpoint (acute non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and time to treatment response. Incidence rates will be estimated in each cohort. Cox proportional hazards models will be used to estimate hazard ratios and assess the potential association between initial therapy strategy and these outcomes.
Analyses will be replicated for patients with grade 1 hypertension and for patients initiating angiotensin-converting enzyme inhibitors and/or calcium-channel blockers. This large population-based study should identify any potential benefits associated with an initially more intensive hypertension treatment strategy.
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Incidence, prevalence, mortality and health-service use among people with systemic sclerosis (scleroderma) in the UK Clinical Practice Research Datalink — Matthew Grainge ...
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Incidence, prevalence, mortality and health-service use among people with systemic sclerosis (scleroderma) in the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-17
Organisations:
Matthew Grainge - Chief Investigator - University of Nottingham
Fiona Pearce - Corresponding Applicant - University of Nottingham
Abhishek Abhishek - Collaborator - University of Nottingham
Jeremy Royle - Collaborator - Nottingham University Hospitals
Peter Lanyon - Collaborator - Nottingham University HospitalsOutcomes:
Incidence Study Diagnosis with systemic sclerosis Healthcare usage Study Number of GP appointments Hospital appointments Number and length of hospital and intensive care admissions Mortality Study Date of death Causes of death
Description: Technical Summary
Objectives:
i) To estimate the incidence, prevalence, mortality
ii) Describe health service usage before and after diagnosis and
iii) Describe leading causes of death in systemic sclerosis in the UK using the CPRD and linked HES and ONS mortality data.Methods and data analysis:
i) We will identify all cases of systemic sclerosis in the CPRD 1995-2014, and estimate incidence and prevalence using the whole CPRD as the denominator population. We will investigate the effects of the a priori confounders age, sex and socio-economic status on incidence using multi-variable Poisson regression, and on prevalence using logistic regression.
ii) In the HES-linked CPRD 1997-2014 we will describe general practice, inpatient and outpatient healthcare usage before and after diagnosis for all incident cases of systemic sclerosis and matched controls.
iii) Finally, in the HES-linked CPRD 1997-2014, we will estimate overall mortality rates using Kaplan-Meier methods, and investigate the effects of age, sex, socio-economic status and year of diagnosis on mortality using multi-variable Cox regression. We will estimate cause-specific mortality rates for people with systemic sclerosis and matched controls and using the cumulative incidence function.
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Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Mortality Study — Jordi Castellsague ...
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Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Mortality Study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-12
Organisations:
Jordi Castellsague - Chief Investigator - RTI Health Solutions
Ana Frances Gonzalez - Collaborator - Astra Zeneca Inc - USA
Christine Bui - Collaborator - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Esther Garcia-Gil - Collaborator - Astra Zeneca Inc - USA
Nuria Riera Guardia - Collaborator - RTI Health Solutions
Susana Perez-Gutthann - Collaborator - RTI Health SolutionsOutcomes:
All-cause mortality
Description: Technical Summary
This nested case-control study aims to evaluate the risk of all-cause mortality in patients initiating aclidinium bromide and other study medications as compared to LABA and in patients initiating aclidinium bromide as compared to patients initiating other COPD medications. The study will also evaluate the effect of duration of use on the risk of death. The case-control is nested in a cohort of patients aged 40 years or under, with COPD initiating aclidinium bromide or other COPD medications in the CPRD in the UK between 2012 and 2016. All confirmed cases of death will be included in the nested case-control study. Density sampling will be used to select four controls for each case. Exposure to study medications will be ascertained by recorded prescriptions in the CPRD. Death and death date, and diagnosis for comorbidities of interest, will be defined based on information from the Office of National Statistics (ONS) Mortality dataset, the inpatient Hospital Episode Statistic (HES) dataset, and GP OnLine Dataset (GOLD). Statistical analysis will include: 1) descriptive statistics of the cohort, 2) descriptive statistics of cases and controls, and 3) conditional multiple logistic regression to estimate crude and adjusted risk ratios for mortality overall and stratified by subgroups of interest.
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Use of novel regression discontinuity design to investigate safety of statins in the UK Clinical Practice Research Datalink — Kate Tilling ...
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Use of novel regression discontinuity design to investigate safety of statins in the UK Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-17
Organisations:
Kate Tilling - Chief Investigator - University of Bristol
Theresa Redaniel - Corresponding Applicant - University of Bristol
Lauren Scott - Collaborator - University of Bristol
Ruta Margelyte - Collaborator - University of BristolOutcomes:
#NAME?
Description: Technical Summary
The evidence surrounding the safety of statins is conflicting despite a number of systematic reviews and meta-analyses. We will use a regression discontinuity analysis (RDA) to assess the effects of statins on both intended and unintended consequences. RDA is a statistical technique that allows for causal inference when a decision rule (such as being above or below a cut-off value on a continuous measure) is used to assign treatment. It is a quasi-experimental method that (like RCTs) reduces the effect of confounding of unobserved variables. The assumption being that patients lying just either side of the cut-off value are similar, in terms of observed and unobserved characteristics. Focussing on a small window surrounding the cut-off value should result in treatment assignment being the only difference between patients. We will therefore look at patient QRISK2 score as the exposure and our outcomes will include cardiovascular disease, future cholesterol levels and future QRISK2 scores (to determine efficacy of statins) and commonly reported side effects such as muscle pain and weakness, nausea and diabetes development (to determine safety). RDA is a novel method in clinical and epidemiological studies and it will provide insights into the causal effects of statins on side effects and also their efficacy.
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Changes in lung function (FEV1) over time in a primary care COPD cohort — Jennifer Quint ...
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Changes in lung function (FEV1) over time in a primary care COPD cohort
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-16
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UK
Steven Kiddle - Collaborator - Astra Zeneca Ltd - UK HeadquartersOutcomes: none known
Description: Technical Summary
People with COPD have a faster decline in their lung function than people without COPD. However, little is known about how quickly lung function decline in a primary care cohort in an average COPD patient. Additionally, among people with COPD the speed with which lung function is lost varies, and these individuals may represent a distinct phenotype. Using a mixed effects liner model, we will investigate decline in lung function in people with prevalent COPD over a 10 year period, we will also stratify this analysis by several important factors to explore whether lung function decline is more rapid in certain groups.
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Drug utilization study of dexamfetamine in European countries — Catrina Richards ...
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Drug utilization study of dexamfetamine in European countries
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-23
Organisations:
Catrina Richards - Chief Investigator - IQVIA Ltd
Birgit Ehlken - Corresponding Applicant - IQVIA ( IMS Health ) France
Anika Staack - Collaborator - MEDICE Arzneimittel Putter GmbH & Co. KG
Dieter Fritsch - Collaborator - MEDICE Arzneimittel Putter GmbH & Co. KG
Jacco Keja - Collaborator - IQVIA ( IMS Health ) France
Nikolaus Kolb - Collaborator - IQVIA ( IMS Health ) FranceOutcomes:
o separate the population that receives dexamfetamine for the treatment of narcolepsy, patients with a Read code for the indication will be excluded. Duration of treatment and occurrence of drug dependence during treatment will be analysed for the remaining population.
Description: Technical Summary
The objectives of the study are to characterise patients who are prescribed dexamfetamine, to describe how dexamfetamine is prescribed by physicians and to evaluate non-intended prescription behaviour by physicians in Europe. This DUS is part of the RMP for dexamfetamine which has been proposed by the marketing authorisation holder of dexamfetamine to the PRAC. Drug utilisation data will be extracted from cross-sectional prescription databases for Finland, Germany, Spain, Netherlands and the UK from longitudinal patient level databases. CPRD data will be used to investigate patient characteristics (age, gender), duration of treatment (stratified by age group) and the incidence of drug dependency during dexamfetamine use (diagnosis of mental and behavioural disorders due to use of other stimulants). All analyses in this study will be purely descriptive.
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Oophorectomy and risk of primary liver cancer and fatty liver disease among women in the UK Clinical Practice Research Datalink — Katherine McGlynn ...
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Oophorectomy and risk of primary liver cancer and fatty liver disease among women in the UK Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-12
Organisations:
Katherine McGlynn - Chief Investigator - National Institutes of Health - USA
Baiyu Yang - Collaborator - Roche
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Jessica Petrick - Collaborator - National Cancer Institute ( NCI )Outcomes:
Primary liver cancer or fatty liver disease, including the subtypes of NAFLD and AFLD
Description: Technical Summary
We aim to conduct two case-control studies to assess the association between oophorectomy and the subsequent development of liver cancer or non-alcoholic fatty liver disease (NAFLD) among individuals in the CPRD. We also propose to include alcoholic fatty liver disease (ALFD) as a comparator group for NAFLD, as the aetiologies underlying these two types of liver disease differ. We will identify all eligible primary liver cancer and fatty liver disease cases in this population, and controls will be matched to cases at a 4:1 ratio on age, sex, general practice, and length of time in the CPRD. Oophorectomy will be classified as ever oophorectomy and bilateral oophorectomy. We will additionally classify oophorectomy by duration of time between oophorectomy and outcome. We will use conditional logistic regression to assess crude and adjusted risk estimates (odds ratios [ORs] and 95% confidence intervals [CIs]) for oophorectomy and the risk of liver cancer or fatty liver disease, subclassified as NAFLD or AFLD. In addition to variables controlled through matching, a comprehensive list of potential confounders will be evaluated.
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Investigating safety of 'metabolically healthy obesity' and sustainability from community and tertiary based databases in the UK — Paul Ziprin ...
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Investigating safety of 'metabolically healthy obesity' and sustainability from community and tertiary based databases in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-28
Organisations:
Paul Ziprin - Chief Investigator - Imperial College London
Osama Moussa - Corresponding Applicant - Imperial College London
Dalton Coker - Collaborator - Imperial College London
Paul Aylin - Collaborator - Imperial College London
Sanjay Purkayastha - Collaborator - Imperial College LondonOutcomes:
We would be looking for primary outcomes of mortality and secondary outcomes of coronary heart disease, stroke, cerebrovascular accident, obstructive sleep apnea, hyperlipidemia as well as depression etc on long term follow up of this cohort.
Description: Technical Summary
In 2014 62% of adults in England were classified as overweight (a body mass index of >25) or obese, compared to 53% 20 years earlier. Our aim is to investigate the impact of management of metabolically healthy obese patients on the NHS compared to non-Healthy Obese. To investigate through retrospective descriptive statistics, the sustainability of being without comorbidities while being morbidly obese through community follow up. This has not been studied before through CPRD and a novel mean of research for benefit of health impact on various demographic and regional distribution of the obesity population. Obesity surgery has been proven beneficial for the metabolically troubled obese, however it has not been proven that this also benefits the healthy obese and hence this will be very beneficial and cost analytical for the impact both of the NHS and worldwide. Read codes for all diagnoses of obesity as well as Medcodes for BMI (Body Mass Index) and comorbidities. Metabolic comorbidities will be determined in primary and secondary databases and, in parallel, relate through HES (length of stay, readmission, in-hospital morbidity and mortality) with CPRD (number of GP consultations, re-referral, resolution of comorbidities). We aim to determine the effect of obesity surgery on this cohort in term of medical outcomes and survival this is as well as resolution of comorbidities and this will be utilised in multilevel and cox regression modelling to determine the effect on survival. This will be in addition to a simple descriptive analysis for the longevity of 'un-healthiness' and survival with and without exposure to obesity surgery. Our study population criteria are - patients over the age of 18 - that have a diagnosis of obesity at any time since initial registration and - (BMI) of or greater than 30. - Patients who are metabolically healthy (ie NO comorbidity)
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Primary Care and Access To Surgical Treatment For Women With Urinary Incontinence — Jan van der Meulen ...
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Primary Care and Access To Surgical Treatment For Women With Urinary Incontinence
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-17
Organisations:
Jan van der Meulen - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rebecca Geary - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Andrew Wilson - Collaborator - University of Leicester
David Cromwell - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Douglas G Tincello - Collaborator - University of Leicester
Ipek Gurol-Urganci - Collaborator - Imperial College London
Jil Billy Mamza - Collaborator - Astra Zeneca Ltd - UK Headquarters
Jonathan Duckett - Collaborator - Medway Primary Care Trust
Masao Iwagami - Collaborator - University of Tsukuba
Mylene Lagarde - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Philip Milton Toozs-Hobson - Collaborator - University Hospital Birmingham
Rebecca Lynch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Simon Cohn - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tahir Mahmood - Collaborator - Victoria Hospital, KirkcaldyOutcomes:
Treatments given in primary care Referral to a gynaecology outpatient clinic Surgical treatment
Description: Technical Summary
Background: Urinary incontinence (UI) affects one in three adult women, but fewer than 20% of them are actively treated, despite UI's wide-ranging impact on employment, social activities and personal relationships. Rates of surgery for UI have increased over the last decade, mostly due to new procedures, but there is evidence of inequity in access and service provision, with concerns of under-provision in vulnerable populations.
Aim: To improve the delivery of surgical care for women with UI.
Objectives: To assess the consistency, completeness and accuracy of data on UI in routine datasets. To examine variations in care, referral patterns and determinants of both.
Methods and Data Analysis: We will develop coding frameworks for UI and relevant treatments by assessing consistency, completeness and accuracy of diagnostic and treatment/procedure codes used in inpatient and outpatient Hospital Episodes Statistics (HES) and Clinical Practice Research Datalink (CPRD). Referral patterns and determinants of referral and surgery will be examined using a linked primary care (CPRD) and secondary care dataset (HES) and multiple regression models. Potential determinants include age, BMI, ethnicity, socio-economic deprivation and patterns of prior care.
Source - and 7 more projects — click to show
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Impact of hospital admission upon patterns of primary care prescribing — Rupert Payne ...
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Impact of hospital admission upon patterns of primary care prescribing
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-17
Organisations:
Rupert Payne - Chief Investigator - University of Bristol
Rachel Denholm - Collaborator - University of Bristol
Richard Morris - Collaborator - University of Bristol
Sarah Purdy - Collaborator - University of BristolOutcomes:
Pre-admission and post discharge long- and short-term prescribing. Primary outcomes: change in total number of medicines following admission, and number of changes in medication following admission. Secondary outcomes: examining change in number of medicines and changes in medication within specific therapeutic areas. The presence of inappropriate prescriptions changes following hospitalisation
Description: Technical Summary
Prescribing is a key therapeutic intervention offered by doctors, with the majority occurring in primary care. Being admitted to hospital can result in considerable changes to a patient's usual medicines, resulting in medication errors and discrepancies. Little is known of the nature of these changes in UK clinical practice, such as which therapeutic areas are affected most and which patients are most likely to experience such changes.
Using data from 100,000 adult patients admitted to hospital in 2014, we will assess overall changes in all medicines immediately (<6 weeks) post-discharge. Secondary outcomes will include changes to specific therapeutic areas, potentially inappropriate prescribing, and further prescription changes by 6 months. Key exposures of interest will be reason for admission, urgency of admission, and length of hospitalisation. Multivariable regression will be used to model the association between outcomes and exposures, with adjustments made for age, gender, socioeconomic status, long-term morbidities, and GP surgery.
This work will provide a valuable insight on prescribing at the primary-secondary care interface. Understanding these issues will inform the improvement of medicines reconciliation processes tailored to relevant therapeutic areas, and help target interventions to those individuals most likely to benefit.
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What are the long-term health outcomes in low birth weight and premature babies born with chronic lung disease who are discharged home on oxygen? — Lisa Szatkowski ...
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What are the long-term health outcomes in low birth weight and premature babies born with chronic lung disease who are discharged home on oxygen?
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-13
Organisations:
Lisa Szatkowski - Chief Investigator - University of Nottingham
Don Sharkey - Collaborator - University of Nottingham
Linda Fiaschi - Collaborator - University of Nottingham
Shin Hui TAN - Collaborator - University of Nottingham
Tricia McKeever - Collaborator - University of Nottingham
William Moreton - Collaborator - University of NottinghamOutcomes:
Part 1. Need for home oxygen Part 2 . Respiratory outcomes:. Episodes of respiratory tract infection Laboratory tests for infection Diagnosis of asthma; Diagnosis of atopy Length of time oxygen required Other health outcomes: . Measures of growth Healthcare resource use:. Primary care consultation rate overall and for specific conditions such as wheeze and asthma Hospital outpatient consultation rate overall and for a respiratory condition; Hospital inpatient admission rate overall and with a respiratory condition as the primary diagnosis; Number of hospital inpatient bed days and days requiring intensive care; Antibiotic prescriptions in primary care; Prescriptions for respiratory medications in primary care.
Description: Technical Summary
In recent decades advances in neonatal intensive care, such as the introduction of antenatal corticosteroid treatment, surfactant administration and improved respiratory support, have led to improvements in the survival of very premature and low birth weight infants. However, chronic lung disease (CLD) remains a major complication of prematurity and low birth weight, and is associated with many short, medium and long-term morbidities, and increased mortality. Despite the growing number of premature and very low birth weight (VLBW) babies surviving into childhood, there are relatively few recent, nationally-representative studies of health outcomes and use of healthcare resources in this group. Using data collected from CPRD and HES, we propose to use repeated cross-sectional analyses to study the prevalence of VLBW and preterm infants discharged on home oxygen and a retrospective cohort study to identify the medium and long-term morbidities (measures of respiratory health, measures of growth) and healthcare resources used (primary and secondary care consultations, inpatient stays, prescriptions) by this cohort in comparison to preterm and VLBW infants without home oxygen and term infants with normal birthweights. This information will provide an understanding of mechanisms, evolution, and consequences of lung disease in these preterm infants, and is essential in developing prevention strategies as well as in the management of these infants in the neonatal period and beyond.
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The relationship between prior antibiotic exposure and antibiotic "response failure" in children presenting with acute respiratory tract infections (RTI) in primary care: an observational cohort study — Clare Bankhead ...
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The relationship between prior antibiotic exposure and antibiotic "response failure" in children presenting with acute respiratory tract infections (RTI) in primary care: an observational cohort study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-10
Organisations:
Clare Bankhead - Chief Investigator - University of Oxford
Oliver Van Hecke - Corresponding Applicant - University of Oxford
Alice Fuller - Collaborator - University of Oxford
Christopher Butler - Collaborator - Cardiff University
Kay Wang - Collaborator - University of Oxford
Michael Moore - Collaborator - University of Southampton
Nicholas Francis - Collaborator - Cardiff University
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
The findings of this study will help improve our understanding of the relationship between previous antibiotic exposure for acute, mostly self-limiting RTIs in preschool children, and the development of further acute RTIs which fail to respond to antibiotics.
Description: Technical Summary
Background
Antibiotic use for self-limiting infections can have harmful consequences. These include the development of antibiotic resistance and disruption to the human microbiome, both of which may predispose individuals to further infections which do not respond to antibiotics. Preschool children under 5 years old with respiratory tract infections (RTIs) have the highest rate of antibiotic prescribing for RTIs in primary care, although most RTIs in this age group are self-limiting (viral) illness.Aim
To explore whether higher levels of antibiotic exposure in children is associated with a greater likelihood of subsequent acute respiratory tract infections (RTIs) failing to respond to antibiotic treatment ("response failures")Research objective
To examine the relationship between prior antibiotic exposure and antibiotic "response failure" in children presenting with acute RTIs in primary careAnticipated outcomes
The findings of this study will help improve our understanding of the relationship between previous antibiotic exposure for acute, mostly self-limiting RTIs and the development of further acute RTIs which fail to respond to antibiotics. Relating the consequences of unnecessary antibiotic use to more tangible and immediately relevant outcomes rather than to theoretical future harms will help inform the development of more effective educational materials and awareness campaigns to promote appropriate antibiotic prescribing and use.
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Trends in NHS prescribing of dual NRT (DNRT) and varenicline in pregnancy and effects on infants — Lisa Szatkowski ...
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Trends in NHS prescribing of dual NRT (DNRT) and varenicline in pregnancy and effects on infants
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-23
Organisations:
Lisa Szatkowski - Chief Investigator - University of Nottingham
Lisa Szatkowski - Corresponding Applicant - University of Nottingham
Laila Tata - Collaborator - University of Nottingham
Timothy Coleman - Collaborator - University of NottinghamOutcomes:
For Study 1 (description of DNRT and varenicline prescribing) and Study 2 (exploration of characteristics of women prescribed DNRT and varenicline) the outcome is prescribing as described above. For Study 3 (comparison of rates of adverse outcomes) the outcome measures which will be assessed are: low birth weight (<2.5kg); preterm birth (<37 weeks gestation); mode of delivery; presence of major congenital abnormality (using the same classifications as in our previous work). We will also present figures for the mean or median (as appropriate) birthweight in kg and gestation in weeks for the different exposure groups. Initially, we will use outcome data as recorded in mothers' and children's primary care records, but for the subset of English practices with linked secondary care HES data we will explore whether outcome data recorded in HES can be used to supplement these. In addition, from HES data we will ascertain whether children were admitted to a neonatal intensive care unit (NICU) at birth and present absolute risks for this outcome.
Description: Technical Summary
Nicotine replacement therapy (NRT) is an effective smoking cessation aid in non-pregnant smokers, but there is evidence of only borderline effectiveness during pregnancy. Low adherence to NRT during pregnancy is the most plausible reason for NRT appearing less effective; nicotine metabolism is much faster in pregnancy and thus NRT is less likely to ameliorate withdrawal symptoms and pregnant smokers are more likely to re-start smoking. Prescribing a higher dose of NRT is a potential way to improve adherence and effectiveness, which might be achieved by use of dual NRT (DNRT), a patch to provide a steady background dose, plus a fast-acting form such as chewing gum to alleviate withdrawal symptoms as they arise. Varenicline is also an effective smoking cessation therapy when used outside of pregnancy. There is currently no evidence that varenicline is teratogenic, but despite this it is not currently licensed for use during pregnancy. It is possible though that some women will inadvertently take varenicline before realising they are pregnant. This study will investigate how many women in the UK are currently being prescribed DNRT or varenicline during pregnancy, and will investigate how frequently adverse outcomes occur in these women compared to pregnant smokers who are not prescribed any stop smoking medications.
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Rates of cytomegalovirus among children with organ transplants — Susan Jick ...
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Rates of cytomegalovirus among children with organ transplants
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-12
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
We will assess the rate of CMV in children who have had an organ transplant at any time in the CPRD data, including transplant of the liver, kidney, heart, lung, pancreas, intestine, or bone marrow. We will start following the children at the date of the first transplant, including those recorded prior to patient registration. CMV cases will be children in the study population who have a CMV code sometime after the first transplant date.
Description: Technical Summary
Using data from the CPRD, we intend to calculate the incidence rate (IR) of cytomegalovirus (CMV) in a paediatric population of organ transplant recipients. We will study all transplant recipients aged <18 and follow them from first transplant code until the end of their record or first CMV code. We will calculate the IR as the number of cases over person time at risk.
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Optimal minimum length of treatment with buprenorphine: A European analysis of medically discontinued opioid dependent patients — Christopher Tyson ...
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Optimal minimum length of treatment with buprenorphine: A European analysis of medically discontinued opioid dependent patients
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-03
Organisations:
Christopher Tyson - Chief Investigator - Applied Healthcare Resource Management Inc - AHRM
Jane Ruby - Collaborator - Reckitt Benckiser Pharmaceutical, IncOutcomes:
Inpatient, outpatient and accident & emergency hospital visits and associated costs Number of prescriptions in primary care Number of consultations and referrals
Description: Technical Summary
The primary objective is to estimate the duration of BMAT that results in an optimal stable outcome which will be defined by resource utilization after treatment.
The CPRD database will be accessed for specified subgroups meeting the inclusion and exclusion criteria. The overall healthcare resource utilization and associated costs will be calculated using publically-available NHS sources. Each patient will be categorized into either low or high resource utilization using the median for all patients as a threshold. Each patient will then be assigned to one of six time-treated (on BMAT) cohorts based on the duration of BMAT.
The primary objective of estimating BMAT duration for optimal stable outcome will utilize Fisherâs exact test to analyse differences in proportions between the high and low resource utilization groups across the six time-treated cohorts.
Secondary analyses to support the primary objective will involve studying the relationship between length of BMAT and various subgroup characteristics (age, gender, comorbidities, etc.) and will utilize logistic regression for multivariate analysis of categorical sub-group variables.
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Renal Outcomes with DPP-4 Inhibitors Compared with Sulfonylurea as Add-on to Metformin among Patients with Type 2 Diabetes Mellitus in the UK — Noam Kirson ...
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Renal Outcomes with DPP-4 Inhibitors Compared with Sulfonylurea as Add-on to Metformin among Patients with Type 2 Diabetes Mellitus in the UK
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-10-12
Organisations:
Noam Kirson - Chief Investigator - Analysis Group, Inc.
Urvi Desai - Corresponding Applicant - Analysis Group, Inc.
Christopher Edmonds - Collaborator - Astra Zeneca Inc - USA
Hung Heong Teh - Collaborator - Astra Zeneca Inc - USA
Jayanti Mukherjee - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Kamlesh Khunti - Collaborator - University of Leicester
Katherine Tsai - Collaborator - MedImmune
Mark Meiselbach - Collaborator - Analysis Group, Inc.
Michael Hellstern - Collaborator - Analysis Group, Inc.
Phillip Hunt - Collaborator - Astra Zeneca Inc - USA
Zitong (Bruce) Jia - Collaborator - Analysis Group, Inc.Outcomes:
Primary outcome: Incident microalbuminuria Other outcomes: Change in baseline category of albuminuria Change in serum creatinine level from baseline Stages of kidney disease as assessed using eGFR.
Description: Technical Summary
The proposed study will assess the comparative effectiveness of using DPP-4 inhibitors vs. SU in addition to metformin in 2007-2014 in terms of incidence of renal outcomes (albuminuria, doubling of serum creatinine, changes in estimated glomerular filtration rate) among T2DM patients with more than 3 months of metformin alone in the UK. In addition, the study aims to describe the characteristics of patients receiving DPP-4 inhibitors vs. SU after more than 3 months of metformin therapy, with the earliest indications of simultaneous use of background metformin and either DPP-4 inhibitor or SU considered as the index date. Baseline covariates will be descriptively compared between the two cohorts using chi-squared tests for proportions and Wilcoxon rank-sum tests for continuous measures. Outcomes will be assessed during at least 12 months after the index date. Time to first occurrence of the outcomes of interest will be described using Kaplan-Meier survival analyses and log-rank p-values. Multivariate Cox proportional hazard models will be used to assess the differences in incidence rates adjusting for baseline differences in demographics (e.g., age, gender), clinical attributes (e.g., renal function, glycemic burden), comorbidities, and other medication use. Sensitivity analyses will estimate K-M curves and Cox models for propensity-score matched cohorts with similar baseline characteristics.
Source
2016 - 09
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Estimating the annual incidence of paediatric burns across the United Kingdom — Alison Kemp ...
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Estimating the annual incidence of paediatric burns across the United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-09-29
Organisations:
Alison Kemp - Chief Investigator - Cardiff University
Emma Johnson - Collaborator - Cardiff University
Hywel M. Jones - Collaborator - Cardiff University
Katie Davies - Collaborator - Cardiff University
Sabine Maguire - Collaborator - Cardiff UniversityOutcomes:
GP consultation for a burn
Description: Technical Summary
The study aims to explore the extent of paediatric burns across the United Kingdom (UK), through estimating the total incidence rates of mortality, hospital admissions (HA), burns service, Emergency Department (ED) and General Practice (GP) attendances for burns in children younger than 16 years in the UK between 2013 and 2015. The incidences of burn attendances at GPs will be obtained using the Clinical Practice Research Datalink (CPRD). Using a cohort of children within CPRD aged less than 16 years, we aim to identify new cases using a time-window algorithm of three weeks, which will be assessed using a sensitivity analysis. Data for the remainder of settings will be collected from routine healthcare datasets and available epidemiology data collection systems. The number of burns for defined years will be extracted from sources and the denominator, namely the population at risk will be identified for CPRD. ONS mid-year 2013 and 2014 England and Wales, Scotland and Northern Ireland population estimates will be used respectively for other settings, assuming all children aged less than 16 years are at risk. Incidence figures will be calculated per 10,000 children for children aged less than 16 years and, where not possible, for the age ranges reported by the source.
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Trends in the prescription of oral anticoagulants in UK primary care (2009-2015) — Samy Suissa ...
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Trends in the prescription of oral anticoagulants in UK primary care (2009-2015)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-09-13
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Laetitia Huiart - Collaborator - University Hospital of La Reunion
Simone Loo - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
All OAC in the British National Formulary (BNF) and that are available in the UK for the prevention of VTE and/or the prevention of stroke in NVAF patients will be identified. Warfarin, phenindione, and acenocoumarol are VKA that fall under the coumarins and phenindione category of the BNF. All VKA (warfarin, acenocoumarin, and phenindione) will be grouped and analyzed as a single OAC class. NOAC to be studied include dabigatran, a direct thrombin inhibitor, as well as rivaroxaban and apixaban which are Factor Xa inhibitors. These NOAC will be analyzed both individually, and together as a single OAC class. Patient demographics including age and sex, as well as risk factors, comorbidities, medications and combined risk factor scores will be used to describe the average patient profile at the time of first prescription, for every year of study and for each OAC class (VKA and NOAC) and individual NOAC (i.e. dabigatran, rivaroxaban, and apixaban). The number of physician visits will also be included as a measure of health utilization. Comorbidities and vascular risk factors to be identified include obesity, smoking status, hyperlipidemia, hypertension, diabetes, ischemic stroke and transient ischemic attack, atrial fibrillation, coronary artery disease, congestive heart failure, peripheral vascular disease, chronic obstructive pulmonary disease, chronic kidney disease, cancer, liver disease, history of bleeding, venous thromboembolism and pulmonary embolism. Concomitant medications will include antiplatelets, NSAIDs, lipid lowering agents, and antihypertensive drugs (beta-blockers, thiazide diuretics, calcium-channel blockers, angiotensin receptor blockers, and angiotensin-converting enzyme inhibitors). CHADS2, CHA2DS2-VASc, and HAS-BLED index scores will also be included within patient profiles as combined risk factor scores and global indicators of susceptibility to stroke (CHADS2 and CHA2DS2-VASc) and major bleeding (HAS-BLED).
Description: Technical Summary
A longitudinal cohort study will be used to analyze trends in OAC prescription rates and patient profiles in the UK, from 2009 to 2015. Incident prescription rates and corresponding 95% confidence intervals of OAC (VKA, NOAC, and individual NOAC) for each calendar year will be estimated using Poisson distribution. Prescription rates will be stratified by age, sex, and indication (where available). We will also estimate the proportion of prescriptions attributable to each OAC in each calendar year, and changes in proportions for VKA and NOAC will be analyzed over time using a chi-squared test for trend. The profile of incident users will be described for each OAC and each calendar year of study, including demographic characteristics, risk factors, comorbidities, medications, and a measure of health utilization. Baseline profiles will be stratified by indication, and analyzed over time and between OAC using one-way ANOVA for means and chi-squared test for proportions. Multivariate logistic regression will be used to model the probability of a NOAC prescription as compared to VKA. The profile of users who switch anticoagulants over the course of the study period will also be analyzed, and stratified by the direction of the switch and by calendar year.
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Hearing problems in adults; mapping the patient pathway and burden recorded within the NHS. — Nishchay Mehta ...
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Hearing problems in adults; mapping the patient pathway and burden recorded within the NHS.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-09-11
Organisations:
Nishchay Mehta - Chief Investigator - University College London ( UCL )
Nishchay Mehta - Chief Investigator - University College London ( UCL )
Nishchay Mehta - Corresponding Applicant - University College London ( UCL )
Nishchay Mehta - Corresponding Applicant - University College London ( UCL )
Andrew Hayward - Collaborator - University College London ( UCL )
Anne Schilder - Collaborator - University College London ( UCL )
Greta Rait - Collaborator - University College London ( UCL )
Hannah Evans - Collaborator - University College London ( UCL )
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Age-related hearing loss Dementia and death
Description: Technical Summary
The objectives are to:
1. a) estimate the proportion of adults that have age-related hearing loss recorded in their medical records and compare this with existing prevalence estimates.
b) map clinical healthcare pathways for patients with hearing loss recorded within the NHS while exploring data completeness of data recording across all data sources used.
2. a) compare characteristics (e.g. age, sex, social deprivation, dementia diagnosis),
b) estimate prognosis (e.g. health care utilisation, all-cause antibiotic prescription [as proxy for health], comorbidities, mortality) of patients with and without age-related hearing loss and
3. compare the prognosis of patients who receive audiological care (including hearing aid hearing aid(s)) earlier compared to those who receive care later or not at all.Objective 1 will inform later analysis decisions. The analysis in 1a-b) is purely descriptive. We will use logistic regression to compare baseline characteristics of people with age-related hearing loss to those without (Objective 2a) and compare baseline characteristics of people who receive audiological care (including hearing aid(s) fitting) earlier or later/not at all (Objective 3a). Multivariable Poisson and cox proportional hazards models as well as matching (e.g. frequency/propensity score matching) will be used to compare prognoses in objective 2b and 3b.
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Metformin and the incidence of viral-induced cancers in patients with Type-2 diabetes — Samy Suissa ...
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Metformin and the incidence of viral-induced cancers in patients with Type-2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-09-21
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Blánaid Hicks - Collaborator - Queen's University Belfast
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Liliya Sinyavskaya - Collaborator - McGill University
Paul Brassard - Collaborator - McGill UniversityOutcomes:
Primary outcome: a primary diagnosis of selected viral-induced cancers as a composite outcome (including hepatocellular carcinoma, Kaposi sarcoma, T-cell leukaemia, Non-Hodgkin's lymphoma, cervical cancer, anal cancer, penile cancer, vaginal cancer, vulvar cancer, and oropharyngeal cancer). Secondary outcomes: site-specific viral-induced cancers.
Description: Technical Summary
Recently, there has been an interest in the anti-tumor effects of metformin, a biguanide used in the treatment of type 2 diabetes. Preclinical studies suggest metformin may have anti-tumor effects on viral induced cancers yet limited observational studies to date have investigated this. This study aims to investigate if metformin is associated with a decreased risk of vial induced cancers. From a cohort of patients newly-prescribed non-insulin antidiabetic medications between January 1 1988 and March 31 2015, all patients with type 2 diabetes (with no prior history of cancer) will be identified. All patients will be followed-up until a first diagnosis of viral-induced cancer or censored upon hysterectomy (with a 3 month window to allow the inclusion of any cervical cancer diagnoses determined at hysterectomy), a death (from any cause), end of registration with the GP or end of the study period (March 31 2016). Time-dependent Cox proportional hazard models will be used to estimate HRs and 95% CIs of viral-induced cancer associated with the use of metformin compared to the use of other diabetic medications. Secondary analyses will investigate cumulative duration of use and cancer site specific associations.
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Prescription trends among drug pairs with a known drug-drug interaction in primary care — Ian Douglas ...
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Prescription trends among drug pairs with a known drug-drug interaction in primary care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-09-11
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Adrian Root - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Bruce Guthrie - Collaborator - University of Edinburgh
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rupert Payne - Collaborator - University of BristolOutcomes:
Primary outcome: the proportion of all registered patients concurrently prescribed a drug pair with a potential drug-drug interaction within the study year. Secondary outcome: the proportion of patients taking a specific drug class who are concurrently prescribed another drug with a potential drug-drug interaction with this drug class in the study year.
Description: Technical Summary
This descriptive observational study will explore the prescribing patterns of drug pairs with a potential drug-drug interaction in primary care over the past two decades by means of repeated cross-sectional studies. The primary outcome will be the proportion of patients in each year exposed to a potential drug-drug interaction. This will be broken down by drug class involved. Time trends between years will be compared by age standardisation and the effects of age, sex, number of concurrent medications and deprivation on the risk of being exposed to a potential drug-drug interaction in 2014 will be investigated by logistic regression. These factors have been associated with risk of potential drug-drug interactions in previous studies. Finally for each drug class, defined by British National Formulary chapter, the proportion of patients prescribed a drug of that class that were exposed to a potential drug-drug interaction will be described as a secondary outcome. This will be compared to the primary outcome to determine the proportion of the absolute variation in exposure to potential drug-drug interactions that is due to variation in the prescription rates of the drugs involved.
Source
2016 - 08
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Validating the CirCom Score in the English CPRD population — Colin Crooks ...
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Validating the CirCom Score in the English CPRD population
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-15
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Colin Crooks - Corresponding Applicant - University of Nottingham
Joe West - Collaborator - University of Nottingham
Peter Jepsen - Collaborator - Aarhus University HospitalOutcomes:
CirCom score Charlson Index
Description: Technical Summary
Objectives
To validate the CirCom score within an English cirrhosis population as a measure of a patientâs co-morbidity burden associated with mortality, and assess whether it is a better measure than the Charlson index.Methods and Data analysis
We have previously defined and validated a cohort of liver cirrhosis patients in the Clinical Practice Research Datalink. We will use this cohort to assess the performance of a Cox Proportional Hazards model predicting all-cause one-year mortality in the linked Office of National Statistics death register. The survival model will consist of age, gender and the CirCom score. Comparisons will be made with the Charlson index using the Bayesian Information Criterion as a measure of goodness of fit, the Brierâs score as a measure of calibration, and the Harrellâs C Statistic and the Net Reclassification index as a measure of discrimination. The performance of the score will be compared to that in the original Danish paper. The results will also be stratified by age, gender, socioeconomic status, cirrhosis aetiology, cirrhosis stage and follow up year from the 1st year to the 5th year following the first diagnosis date of cirrhosis.
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Comprehensive ascertainment of bleeding in patients prescribed different combinations of dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant) after coronary interventions in the UK (The ADAPTT Study). — Maria Pufulete ...
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Comprehensive ascertainment of bleeding in patients prescribed different combinations of dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant) after coronary interventions in the UK (The ADAPTT Study).
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-14
Organisations:
Maria Pufulete - Chief Investigator - University of Bristol
Andrew Mumford - Collaborator - University of Bristol
Barnaby Reeves - Collaborator - University of Bristol
Chris Rogers - Collaborator - University of Bristol
Daniel Lasserson - Collaborator - University of Birmingham
Jessica Harris - Collaborator - University of Bristol
Jonathan Sterne - Collaborator - University of Bristol
Koen Pouwels - Collaborator - University of Oxford
Sarah Wordsworth - Collaborator - University of Oxford
Tom Johnson - Collaborator - University of Bristol
Umberto Benedetto - Collaborator - University of Bristol
Yoon Loke - Collaborator - University of East AngliaOutcomes:
Primary: any bleeding event (classified as minor or major using the Bleeding Academic Research Consortium (BARC) bleeding scale). For each patient we will define all bleeding events in HES and CPRD (and cross-validate hospital admissions in HES) during follow-up. Secondary outcomes will be: any major bleeding event; any minor bleeding event; all-cause mortality; cardiovascular mortality; mortality from bleeding (these will be identified from linked Office for National Statistics (ONS) data) and hospital admission for a bleeding event (Inpatient HES).
Description: Technical Summary
Objective: To quantify the incidence of all bleeding events in patients exposed to different regimens of dual antiplatelet therapy (DAPT) or triple therapy (DAPT and an anticoagulant) and to estimate hazard ratios for bleeding for different antiplatelet regimens.
Methods: Retrospective population-based cohort study. We will identify three patient cohorts, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), and acute coronary syndrome (ACS) treated by medication only, in Hospital Episode Statistics (HES). We will follow all patient cohorts through CPRD GOLD. For the PCI cohort we will compare aspirin and clopidogrel (AC, reference) vs. aspirin and prasugrel (AP) or aspirin and ticagrelor (AT). For the CABG and ACS cohorts we will compare aspirin (reference) vs. AC. (For all three cohorts we will also compare AC, AP or AT (reference) vs. triple therapy, TT). The primary outcome will be any bleeding event. Secondary outcomes will be all-cause mortality; cardiovascular mortality; mortality from bleeding; hospital admission.
Data analysis: We will calculate crude and adjusted rates of bleeding (events/person time) with 95% confidence intervals (CIs) for each exposure group and use Cox proportional hazards models to estimate adjusted hazard ratios (HRs) with 95% CIs for time to first bleeding event.
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Weight loss as a predictor of cancer and serious disease in primary care. — Clare Bankhead ...
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Weight loss as a predictor of cancer and serious disease in primary care.
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-21
Organisations:
Clare Bankhead - Chief Investigator - University of Oxford
Brian Nicholson - Corresponding Applicant - University of Oxford
Alice Fuller - Collaborator - University of Oxford
Diana Withrow - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Paul Aveyard - Collaborator - University of Oxford
Rafael Perera - Collaborator - University of Oxford
Richard Hobbs - Collaborator - University of Oxford
William Hamilton - Collaborator - University of ExeterOutcomes:
Outcome 1 - Objective weight measurement. Outcome 2 - Weight loss code.
Description: Technical Summary
The overall aim is to provide the evidence necessary to allow GPs to more effectively manage patients with unexplained weight loss.
Research questions
Review of the existing evidence exposes key evidence gaps where questions remain unanswered:1) How often and when is weight measured, and the symptom of unexpected weight loss coded, in NHS primary care?
2) What is the diagnostic predictive value of recorded weight loss, volunteered or elicited as a symptom, for cancer and serious disease in primary care?
Methods
A cohort analysis of UK Clinical Practice Research Datalink (CPRD) data to: 1) Describe how often the symptom of reported weight loss is recorded, and when weight is measured in NHS primary care; 2) Identify the predictive value of recorded weight loss for cancer and serious disease in primary care. The cohort analysis will compare the incidence of cancer over time in those with and without weight loss, using Cox regression to explore and adjust for covariates as appropriate. Preliminary work in CPRD estimates that weight loss as a symptom is recorded for about 52,500 patients >40 years, providing adequate statistical power and precision in relation to cancer overall and common cancers individually.
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Metabolic syndrome and risk of meningioma - population-based case-control analysis — Christoph Meier ...
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Metabolic syndrome and risk of meningioma - population-based case-control analysis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-01
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Collaborator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Michael Leitzmann - Collaborator - University of Regensburg
Peter Hau - Collaborator - University of Regensburg
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Ulrich Bogdahn - Collaborator - University of RegensburgOutcomes:
The association between metabolic syndrome and risk of meningioma
Description: Technical Summary
Using data from the CPRD, we intend to perform a matched case-control analysis to explore the association between metabolic syndrome and risk of meningioma. Cases will be individuals with an incident diagnosis of meningioma between 1995 and 2015. We will match ten control patients to each case on age, sex, calendar time, general practice, and number of years of active history in the CPRD prior to the index date. Relative risks will be estimated by conducting conditional logistic regression analyses to determine odds ratios (ORs) with 95% confidence intervals (CIs) Analyses will be adjusted for various potential confounders.
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Reproductive risk factors for prostate cancer incidence, mortality and survival — Michael Cook ...
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Reproductive risk factors for prostate cancer incidence, mortality and survival
Datasets:GP data, Michael Cook - Chief Investigator - National Cancer Institute ( NCI )
Michael Cook - Corresponding Applicant - National Cancer Institute ( NCI )
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Eboneé Nicole Butler - Collaborator - National Cancer Institute ( NCI )
Scott Kelly - Collaborator - National Cancer Institute ( NCI )Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-16
Organisations:
Michael Cook - Chief Investigator - National Cancer Institute ( NCI )
Michael Cook - Corresponding Applicant - National Cancer Institute ( NCI )
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Eboneé Nicole Butler - Collaborator - National Cancer Institute ( NCI )
Scott Kelly - Collaborator - National Cancer Institute ( NCI )Outcomes: none known
Description: Technical Summary
We propose to investigate whether reproductive factors are associated with risks of incident prostate cancer, death from prostate cancer, and survival among prostate cancer cases. This nested case-control study in the Clinical Practice Research Datalink (CPRD) will be comprised of prostate cancer cases with incidence-density matched controls based on a 4:1 ratio using the variables age, general practice, and length of time in CPRD.
In the main analysis we will assess specified reproductive factorsâ vasectomy, infertility, sexually-transmitted diseases (STDs), erectile dysfunction, prostatitis, and varicoceleâin relation to risks of incident prostate cancer, prostate cancer death, and prostate cancer survival using all available data from CPRD GOLD, HES Inpatient and Outpatient, NCDR Cancer Registry, and ONS Mortality data to define exposures and outcomes. Sensitivity analyses will test whether any result is affected by the time-limits of the database linkages. For prostate cancer incidence and death, we will use conditional logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs). For the case-only prostate cancer survival analyses, we will use Cox proportional hazards regression to estimate hazard ratios (HRs) and 95% CIs.
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Domperidone for insufficient lactation: a drug utilization study with interrupted time-series analysis — Samy Suissa ...
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Domperidone for insufficient lactation: a drug utilization study with interrupted time-series analysis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-22
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Adrian Root - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Azar Mehrabadi - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill UniversityOutcomes:
Domperidone prescriptions up to one year following childbirth (prevalence, dose, timing and duration)
Description: Technical Summary
The purpose of this study is to describe the prescribing practices of domperidone for insufficient lactation in terms of the demographic, obstetric, and medical profile of the women receiving prescriptions, and domperidone dosage, length of time prescribed, and the co-prescribing of medications capable of causing abnormalities in heart rhythm. In addition, we will determine whether prescriptions of domperidone decreased following a recommendation to restrict its usage. We will conduct a retrospective cohort analysis of women who delivered a live birth between April 1, 2002 and March 31, 2015 using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics. We will use information recorded by general practitioners about domperidone prescriptions written for women in the year following childbirth and obstetric characteristics will be based on information recorded during the birth hospitalization and medical records during the pregnancy. We will describe the patterns of prescription of domperidone postpartum and compare the characteristics of women using domperidone to women not using the medication. Interrupted time series analyses will be used to determine whether prescribing of domperidone decreased following a recommendation restricting the use of domperidone due to concerns about a potential increased risk of heart attack deaths associated with its use.
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Proton pump inhibitors and kidney disease: a self-controlled case series and cohort study — Ian Douglas ...
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Proton pump inhibitors and kidney disease: a self-controlled case series and cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-14
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Adrian Root - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kaiti Tseng - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Hospitalisation for acute kidney injury
Description: Technical Summary
We aim to assess the link between PPIs and renal disease. We will use: i) a self-controlled case series study (SCCS) to compare AKI, within individuals, during periods of exposure to PPIs compared to baseline unexposed time; and ii) a cohort study to investigate the effect of omeprazole on kidney disease compared to other PPIs.
In the SCCS, we will identify new PPI users who have at least one AKI event. We will use conditional Poisson regression to investigate the relative rate of AKI during periods exposed to PPIs compared to that during unexposed periods. We will repeat the analysis using cataract surgery as a negative control outcome. We do not expect cataract surgery to be associated with PPIs, a negative association in this analysis will therefore increase our confidence in any positive association observed between PPIs and AKI.
In the cohort study, we will identify new users of omeprazole, lansoprazole, and pantoprazole. Existing research has focussed on the renal effects of PPIs as a class, there is little information regarding whether different PPIs have different effects on renal outcomes. We will therefore use Poisson regression to compare rates of AKI and incident CKD during omeprazole use (first generic introduced and most commonly prescribed PPI) compared to other PPIs.
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A feasibility study to develop within primary care IT systems a computer program for flagging patients with risk factors for HIV who would benefit from having an HIV test — John Macleod ...
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A feasibility study to develop within primary care IT systems a computer program for flagging patients with risk factors for HIV who would benefit from having an HIV test
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-21
Organisations:
John Macleod - Chief Investigator - University of Bristol
John Macleod - Corresponding Applicant - University of Bristol
Jonathan Rougier - Collaborator - University of Bristol
Margaret May - Collaborator - University of Bristol
Mark Gompels - Collaborator - North Bristol NHS Trust
Skevi Michael - Collaborator - University of Bristol
Tim Jones - Collaborator - University of BristolOutcomes:
The outcome for determining testing rates in primary care is whether a person has undergone an HIV test.The outcome for research on the HIV risk algorithm is HIV positive, denoted either by a positive HIV test result or recorded that HIV positive/AIDS recorded in CPRD, or died with HIV mentioned on the death certificate as recorded by ONS death registry.
Description: Technical Summary
We aim to detect undiagnosed HIV infection (25% of all people living with HIV in the UK) using a risk algorithm that can be incorporated into GP IT systems (e.g EMIS). These individuals are often seen in Primary Care with risk factors for HIV acquisition or clinical symptoms associated with HIV disease but the need for an HIV test may not be apparent to the GP, particularly in lower prevalence areas. We will undertake a feasibility study using retrospective data:
i) Using CPRD data we will determine HIV testing rates in the GP setting by calendar year, sex and age.
ii) We will investigate which risk factors are predictive for HIV and the clinical symptoms they experienced prior to or at diagnosis of HIV. We will fit candidate predictive models based on these factors to discriminate between HIV-positive and negative individuals.
iii) We will evaluate the specificity, sensitivity and positive predictive value of candidate models based on different configurations of risk factor information.
iv) The discrimination of the model with optimum performance characteristics will be further assessed in a retrospective analysis of GP data in two local practices and refined if sensitivity and specificity suggests this is needed.
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External validation of risk scores for dementia in the CPRD population — Michael Soljak ...
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External validation of risk scores for dementia in the CPRD population
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-15
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Anita Kulatilake - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Bowen Su - Collaborator - Imperial College London
Lefkos Middleton - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes:
Dementia diagnosis
Description: Technical Summary
This will be an open retrospective longitudinal cohort study. Data on dementia risk factors (including CVD outcomes) will be analysed. Our outcome of interest will include all participants with either a diagnosis of dementia or probable dementia based on a diagnostic algorithm including cognitive test results, prescribing and test data. The aim is to estimate the incidence and prevalence of diagnosed and probable dementia, to validate two existing risk scores, and to compare their discrimination and calibration to score developed using a broader definition of dementia and additional risk factor data, including for the first time ethnicity.
We will draw upon the TRIPOD guideline and previous CPRD validations, and using Cox regression we will apply the algorithm for each score to eligible patients in the CPRD study cohort to obtain predicted risks for each of the relevant clinical outcomes. We will then test the performance of each score in the CPRD cohort and compare it with the published results from the original validation cohorts using C- and D-statistics and an R2 statistic. The results will be utilised almost immediately by the MULTIMODE project, which will adopt the best performing score for use in identifying patients to be offered participation in the pilot programme.
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Hormone Therapy in Relation to Risks of Second Cancers and Mortality Among Women and Men — Michael Cook ...
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Hormone Therapy in Relation to Risks of Second Cancers and Mortality Among Women and Men
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-22
Organisations:
Michael Cook - Chief Investigator - National Cancer Institute ( NCI )
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )
Cher Dallal - Collaborator - University Of Maryland
Cindy Zhou - Collaborator - National Cancer Institute ( NCI )
Gretchen L Gierach - Collaborator - National Cancer Institute ( NCI )
Jessica Petrick - Collaborator - National Cancer Institute ( NCI )
Liam Murray - Collaborator - Queen's University Belfast
Maeve Mullooly - Collaborator - National Cancer Institute ( NCI )
Marie Bradley - Collaborator - Food and Drug Administration - FDA
Rajrupa Ghosh - Collaborator - National Cancer Institute ( NCI )
Ãna McMenamin - Collaborator - Queen's University BelfastOutcomes:
Incident second primary malignant cancer, and disease-specific (e.g., prostate/breast cancer-specific mortality and deaths by organ system), and all-cause mortality using the underlying cause of death in ONS mortality data.
Description: Technical Summary
Men experience ~50% more cancer incidence and ~70% more cancer-related mortality, compared with women. In addition to established risk factors that differ in prevalence by sex, such as smoking and obesity, sex hormones have been hypothesized to explain part of excessive cancer risks in men but little epidemiological evidence exists. To further understand the influence of hormones on cancer risk, we propose to assess the use of hormone therapy, commonly used to treat breast and prostate cancers, in relation to risks of second cancers and deaths. We propose to construct a female breast cancer cohort and male prostate cancer cohort. The exposure of interest will be anti-estrogens and androgen deprivation therapy (ADT), respectively. Hormone therapy includes medication use and surgical procedures after a first primary breast cancer or first primary prostate cancer diagnosis. Cox proportional hazards regression will be used to calculate adjusted hazard ratios (HRs) and 95% confidence intervals (95%CIs) for the associations of hormone therapy in relation to risks of second primary cancer and mortality. Propensity scores will be used to control for potential confounding. The proposed study will substantially add to the literature on our understanding of how sex steroid hormones are associated with risks of second cancer and mortality.
Source - and 6 more projects — click to show
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Comparison of information on diagnosis of musculoskeletal outcomes in the Million Women Study cohort and CPRD-GOLD: a record linkage study — Jane Green ...
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Comparison of information on diagnosis of musculoskeletal outcomes in the Million Women Study cohort and CPRD-GOLD: a record linkage study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-01
Organisations:
Jane Green - Chief Investigator - University of Oxford
Dominic Furniss - Collaborator - University of Oxford
Jennifer Lane - Collaborator - University of Oxford
Lucy Wright - Collaborator - University of Oxford
Md Shajedur Rahman Shawon - Collaborator - University of Oxford
Owen (Tien Yu) Yang - Collaborator - University of Oxford
Valerie Beral - Collaborator - University of OxfordOutcomes:
Bone fractures Carpal tunnel syndrome Hip and knee replacement Osteoarthritis of base of thumb
Description: Technical Summary
In order to inform risk factor analyses within the Million Women Study cohort, we wish to continue using the linked CPRD-Million Women Study dataset provided to us in 2014 under Protocol 12-070R3.
The aim is to use information on primary care and outpatient activity in CPRD to supplement available study data (self-reported, medical records, and linked coded hospital admissions, death and cancer follow-up data provided to us through HSCIC). Using basic tabulation and description of data for comparisons, we will assess the reliability and completeness of coded NHS data (such as HES) for diagnostic outcomes, and of self-reported prescribing data for exposures. This new proposal deals with musculoskeletal outcomes (fracture, arthritis, joint replacement, carpal tunnel syndrome).
Large UK cohorts benefit from the availability of long term, cost effective, unbiased follow-up through linkage to NHS records: it is important to assess the reliability of such records for large-scale epidemiology, and to make the results available to others. There is very limited existing information. Our policy is to publish our results as methodological papers, or with adequate key word notification as part of analysis papers, and to ensure that data providers are kept informed.
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Cohort study on the uptake of pharmacological treatments to prevent cardiovascular diseases in UK cancer survivors versus general population from 2005-2013. — Krishnan Bhaskaran ...
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Cohort study on the uptake of pharmacological treatments to prevent cardiovascular diseases in UK cancer survivors versus general population from 2005-2013.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-15
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kendal Chidwick - Corresponding Applicant - Not from an Organisation
Anthony Matthews - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Blood pressure, lipids, CVD risk score recorded in the past 1,3 and 5 years according to age, gender and year since cancer diagnosis Markers of cardiovascular risk including serum cholesterol, systolic and diastolic blood pressure First prescription of statin therapy recorded within 1 month (and 3 months in sensitivity analysis) of first high CV risk record First prescription of antihypertensives (AHT) recorded within 1 month (and 3 months in sensitivity analysis) of first high CV risk record Time from eligibility to first initiation of a statin/AHT Time from statin initiation to first cessation of therapy Time from AHT initiation to first cessation of therapy
Description: Technical Summary
This retrospective cohort study in Clinical Practice Research Datalink (2005-2013) aims to understand whether recommended risk factor monitoring (blood pressure, cholesterol, cardiovascular disease risk scores) and pharmacological interventions (statins and antihypertensives) to prevent cardiovascular disease are optimally implemented among cancer survivors versus the general population; and whether persistence on preventive therapies is different in cancer survivors.
The study population will be drawn from all research quality patients in CPRD who were 40 years or older between 2005 and 2013. Follow-up time will be categorised as non-cancer, first year since cancer diagnosis, and â¥1 year since cancer diagnosis (i.e. cancer survivors). Only patients with a cardiovascular risk score recorded will be included in the statin uptake analysis and those who initiate a statin the persistence analysis.
Descriptive statistics will be used to describe baseline demographics and cardiovascular risk distribution of the cancer survivors cross-tabulated with controls. Logistic regression modelling will be used to produce unadjusted and adjusted ORs, to estimate the association between cancer survivorship and initiation of therapy among those with high recorded cardiovascular risk, adjusted for confounders. We will measure time-to-discontinuation of therapy using Kaplein Meier curves. Hazard ratios for persistence will be estimated using Cox proportional hazards model.
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The role of social determinants in vaccine uptake and burden of vaccine preventable diseases — Sara Thomas ...
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The role of social determinants in vaccine uptake and burden of vaccine preventable diseases
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-23
Organisations:
Sara Thomas - Chief Investigator - Not from an Organisation
Albert J. van Hoek - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Anu Jain - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
An incident zoster diagnosis Zoster vaccine uptake Childhood intranasal influenza vaccine uptake
Description: Technical Summary
Addressing inequalities in vaccine uptake to prevent infections in children and in adults is a key priority for public health. In England, current surveillance methods provide little information about social factors associated with the burden of vaccine-preventable diseases or vaccine uptake. These social factors may vary for older individuals and children.
This project will use linked electronic health records and a cohort study design to investigate the association between selected social factors and uptake of two vaccines introduced in England in 2013; zoster vaccine in older individuals and intranasal influenza vaccine in young children. Similarly, the association between social factors and incidence of zoster in older individuals will be investigated, to assess whether some individuals are doubly disadvantaged (less likely to receive zoster vaccine and more likely to develop zoster). A hierarchical modelling approach will be used to investigate the effects of upstream and downstream social determinants of vaccine uptake and burden. The results of this project will enhance existing surveillance methods and should help to address vaccine-related health inequities.
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Body mass index and cause-specific mortality - population-based cohort study using record linkage — Krishnan Bhaskaran ...
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Body mass index and cause-specific mortality - population-based cohort study using record linkage
Datasets:GP data, ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-23
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
David Leon - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Isabel dos-Santos-Silva - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
All-cause mortality Cause specific mortality (Global Burden of Diseases classification)
Description: Technical Summary
Body mass index (BMI) is associated with all-cause mortality, but few large studies have explored associations with death from specific causes. Our objective is to comprehensively investigate associations between BMI and specific causes of death. We will used CPRD primary care data linked to Office of National Statistics mortality data. All individuals with a BMI record in the Clinical Practice Research Datalink (CPRD) will be included. Outcomes will be underlying causes of death, using categorisations developed as part of the Global Burden of Disease project. We will look at both broad and specific categories/groupings of causes of death. We will use Cox regression models based on cause-specific hazards to model the associations between BMI and each cause-specific mortality outcome, adjusting for key potential confounders. We will use cubic splines to allow for non-linearity, and we will fit interactions to investigate effect modification by individual level factors. We will also use competing risks methods to estimate cumulative incidences for each outcome, stratified by BMI category.
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Residual Risk and Burden of Cardiovascular Diseases in the United Kingdom — Dimitra Lambrelli ...
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Residual Risk and Burden of Cardiovascular Diseases in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-16
Organisations:
Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Marta Pereira - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Robert Donaldson - Collaborator - Evidera, Inc
Selin Cooper - Collaborator - Evidera, Inc
Sharon MacLachlan - Collaborator - Evidera, Inc
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political ScienceOutcomes:
Composite cardiovascular event Myocardial infarction (any, fatal, and non-fatal) Stroke (ischemic, haemorrhagic, and other strokes) (any, fatal, and non-fatal) Coronary revascularization (coronary artery bypass grafting, percutaneous coronary intervention, thrombolysis) Transient ischemic attack (TIA). Unstable angina Stable angina Unstable angina-related hospitalization Unstable angina requiring revascularization Cardiovascular-related death All-cause mortality Cardiovascular-related hospitalizations
Description: Technical Summary
Cardiovascular diseases (CVD) are the leading cause of death in England and Wales, accounting for almost 1/3 of all deaths and around 1.7 million episodes in NHS hospitals annually. The majority of risk factors for CVD are modifiable, such as high blood cholesterol Prescriptions of statin or other non-statin medications aiming to lower low-density lipoprotein (LDL) cholesterol are first choice in the management of patients with high CVD risk. Despite LDL cholesterol lowering, the risk of CVD remains significant. To reduce further the risk of CVD events, it is important to understand the factors associated with those events in patients treated with lipid-lowering medications. This study aims to assess clinical and demographic characteristics of patients on cholesterol lowering therapy, including patterns of prescribed medications and variation LDL levels; describe the burden of disease in terms healthcare resource use and incidence of cardiovascular events; and assess predictors of those events. This study will be primarily exploratory and hypothesis generating in nature. Descriptive analysis, and univariate and multivariate Cox regression models will be used. Subgroup analyses will be implemented for known CVD risk factors: subjects with and without familial hypercholesterolemia and with/without chronic kidney disease and diabetes.
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Obstructive airway disease phenotype discovery using cluster analysis techniques in CPRD — Spiros Denaxas ...
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Obstructive airway disease phenotype discovery using cluster analysis techniques in CPRD
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-08-01
Organisations:
Spiros Denaxas - Chief Investigator - University College London ( UCL )
Francis Nissen - Collaborator - Roche
Jennifer Quint - Collaborator - Imperial College London
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Maria Pikoula - Collaborator - University College London ( UCL )Outcomes:
Clinical phenotypes of asthma and COPD Death Hospital admissions
Description: Technical Summary
Asthma and COPD are both obstructive airways diseases, and are chronic. Asthma is characterised by recurrent episodes of wheeze, breathlessness, chest tightness and cough. COPD, is characterised by airflow obstruction that is not fully reversible, and patients often have symptoms of cough, breathlessness, recurrent infections and wheeze. The expiratory airflow limitation in asthma is reversible, in contrast to chronic obstructive pulmonary disorder (COPD). Asthma and COPD are very heterogeneous diseases, with groups of clinical, pathophysiological and demographic characteristics called phenotypes. Additionally, both disease can overlap (asthma COPD overlap). Currently, there is not much known about the relationship between pathological features, clinical patterns of disease and response to treatment.
In this study, we will use an approach named clustering analysis to try to identify asthma and COPD phenotypes in CPRD. Clustering is an exploratory approach in which can be used to identify subtypes in diseases. Cluster analysis to identify asthma and COPD phenotypes has been used in smaller studies. However, cluster analysis of a larger patient database could lead to the improved identification and characterisation of asthma and COPD phenotypes which would otherwise be grouped into broader disease aggregates.
Source
2016 - 07
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Safety and associated costs of glucocorticoid therapy for the treatment of chronic inflammatory diseases — Ann Morgan ...
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Safety and associated costs of glucocorticoid therapy for the treatment of chronic inflammatory diseases
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-27
Organisations:
Ann Morgan - Chief Investigator - University of Leeds
Ann Morgan - Corresponding Applicant - University of Leeds
Chris Bojke - Collaborator - University of Leeds
Mar Pujades Rodriguez - Collaborator - University of Leeds
Paul David Baxter - Collaborator - University of Leeds
Paul Stewart - Collaborator - University of Leeds
Richard Hubbard - Collaborator - University of Nottingham
Samantha Crossfield - Collaborator - University of LeedsOutcomes:
Glucocorticoid toxicity All-cause hospitalisation Hospitalisation for toxicity Death for toxicity All-cause mortality
Description: Technical Summary
The aim of this research is to develop tools that enable clinicians and policy decision makers to balance harms and benefits of glucocorticoids for the treatment of chronic inflammatory diseases. This will be achieved through; 1) description of glucocorticoid toxicity profiles and its predictors; and 2) development of treatment stratification tools for clinical evaluation to accurately identify patients at increased risk of developing toxicity. This research will enable informed personalised adaptation of treatment for patients identified with high risk of toxicity (e.g. earlier dose reduction or use of glucocorticoid-sparing therapies), improvement of clinical guidelines and quality of care and equity in health care provision, ultimately improving long-term patient outcomes.
To estimate toxicity rates and describe toxicity patterns we will expand our phenotyping work to identify patients with common chronic inflammatory diseases and adverse events. The description of common patterns of toxicity, overall and in patients with different underlying diseases and age groups, and the exploration of the relative importance of duration of medication and dose will inform the construction of risk prediction models to enable patient risk stratification according to risk of toxicity development and the future development of decision cost-models to guide policy and clinical decision making.
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Use of Nalmefene (Selincro) in the UK: Cohort design using longitudinal electronic medical records (EMR) — Lianna Ishihara ...
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Use of Nalmefene (Selincro) in the UK: Cohort design using longitudinal electronic medical records (EMR)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-19
Organisations:
Lianna Ishihara - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Celine Darricarrere - Corresponding Applicant - Lundbeck Limited
Celine Quelen - Collaborator - Creativ-Ceutical
Didier Meulien - Collaborator - Lundbeck Limited
Florence COSTE - Collaborator - Sanofi Aventis Recherche & Développement
Florence TUBACH - Collaborator - Paris Diderot University
Francoise Diamand - Collaborator - Not from an Organisation
Gitte Dyhr - Collaborator - Lundbeck Limited
Loan Honeywell - Collaborator - Lundbeck Limited
Per Sorensen - Collaborator - Lundbeck Limited
Sylvie Guillo - Collaborator - Hopital BichatOutcomes:
Demographic and clinical characteristics including psychiatric disorders and somatic comorbidities.
Description: Technical Summary
The primary study objective is to describe the proportion of pre-defined sub-populations of interest in the overall population of patients initiating Selincro.
The secondary objectives are to describe the proportion of patients treated with Selincro for more than one year, the percentage of patients with a number of Selincro prescriptions exceeding the daily intake (overdose), the percentage of women who are pregnant during the course of Selincro treatment, and the percentage of patients who are outside the licensed indication (off-label use) at the time of Selincro initiation.
This study is an historical cohort using Clinical Practice Research Datalink (CPRD) GOLD, an Electronic Medical Record database held by a network of general practitioners (GPs). Patients with a first prescription record of Selincro between May 2013 and June 2016 are included. The study period for each patient will be 18 months.
This analysis is purely descriptive and no statistical test will be performed.
Missing values will be displayed when appropriate.
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Statin use and incident hand osteoarthritis: A propensity-score matched sequential cohort study — Christoph Meier ...
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Statin use and incident hand osteoarthritis: A propensity-score matched sequential cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-04
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Marlene Rauch - Corresponding Applicant - University of Basel
J. Bradley Layton - Collaborator - RTI Health Solutions
Julia Spoendlin - Collaborator - University of Basel
Noel Frey - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Theresa Burkard - Collaborator - University of Basel
Thomas Huegle - Collaborator - University of BaselOutcomes:
Hand osteoarthritis
Description: Technical Summary
We plan to perform a propensity score (PS)-matched sequential cohort study to assess the relative risk of incident hand OA associated with new statin use. Statin initiators will be matched to non-initiators on their PS within 2 year enrolment blocks (to avoid time trend bias) after completion of a 180 day run-in period (to allow statin users to reach maintenance dose). After concatenating all blocks into one dataset, we will follow all patients from the day after they complete the run-in period to the first of the following: a maximum of 5.5 years of follow up, a record for hand OA, or end of the patient record. In the statin exposed cohort person time will be accumulated as exposed or non-exposed time according to prescriptions received. We will perform subgroup analyses by sex, age groups, subgroups of daily statin dose (in simvastatin equivalents), the specific statin agent used, and by indication for statin use. Cox proportional hazard analyses will be performed to calculate hazard ratios (HR) with 95% confidence intervals (CI). This will be the first observational study to specifically assess the association of statin initiation and incident hand OA, while controlling for confounding by indication by means of PS matching.
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Association between cardiovascular disease and zoster risk - case-control study in the Clinical Practice Research Datalink — Sinead Langan ...
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Association between cardiovascular disease and zoster risk - case-control study in the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-27
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Cardiovascular diseases (myocardial infarction, any ischaemic heart disease, stroke, heart failure, atrial fibrillation/flutter)
Description: Technical Summary
Three recent exploratory studies have suggested a small but increased risk of herpes zoster (or shingles) associated with cardiovascular disease. We have also recently found increased zoster risks in statin users. Our group have also shown a transient increased risk of cardiovascular events (myocardial infarctions and strokes) following zoster. The reasons for increased zoster risks following cardiovascular disease are not understood.
Our aim is to investigate the relationship between cardiovascular diseases and risks of zoster and post-herpetic neuralgia (prolonged pain after shingles). We will conduct a matched case-control study: all individuals with an incident zoster diagnosis will be identified and matched on age, sex and GP practice to people who are under follow-up in HES-linked CPRD (using incidence density sampling) at the same time but have no history of zoster. Conditional logistic regression models will be used to examine associations between cardiovascular disease (ischaemic heart disease, myocardial infarction, atrial fibrillation, heart failure and stroke) and zoster, adjusting for a range of potential confounders, including stratifying by statin use. The timing of the relationship between cardiovascular disease and zoster will also be examined. Study findings will have important implications for patients, doctors and will inform vaccination policy.
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Estimation of undiagnosed lysosomal acid lipase deficiency in a paediatric population: a UK database study — Christopher Morgan ...
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Estimation of undiagnosed lysosomal acid lipase deficiency in a paediatric population: a UK database study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-19
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Alexander Cole - Collaborator - Alexion Pharmaceuticals
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Shona Fang - Collaborator - Alexion PharmaceuticalsOutcomes:
The specific aim of the study is to identify a paediatric (2-18 years) population with both elevated low density lipids (LDL) and elevated alanine aminotransferase (ALT) in order to estimate a potentially undiagnosed population with LAL deficiency. We then wish to consider:. the prevalence of patients with these characteristics recorded diagnoses for this population therapies prescribed to this population
Description: Technical Summary
We aim to estimate the prevalence of undiagnosed Lysosomal acid lipase deficiency in a UK population based on the Clinical Practice Research Datalink and to tabulate the most commonly associated diagnoses and therapies. To achieve this we will use primary-care data from CPRD GOLD and secondary-care data from the linked Hospital Episode Statistics (HES). Patients (aged 2-18) will be identified based on either low density lipids > =130 mg/dL or High Density Lipids <40 mg/dL for males or <50mg/dL for females) and a test result for alanine transaminase > 1.5 x upper normal range occurring within +/-3 months of each other. Period prevalence will be calculated for 2014, using live patients registered within an up-to-standard (UTS) practice on the mid-year point (30th June 2014) as the denominator. Diagnoses and symptoms will be aggregated by Read code for CPRD GOLD data and ICD-10 codes for the HES dataset and presented in tabular format. Therapy codes will be aggregated by individual drug type and British National Formulary chapter and presented in tabular format. A sensitivity analysis based on patients eligible for the linkage scheme will also be performed. Findings will be summarised with wide granularity and all cells with n<5 suppressed in accordance with CPRD guidelines to prevent the risk of deductive/unintentional disclosure.
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Patient Characteristics Associated With Initiation Of Insulin Glargine Among Patients With Type 1 Or Type 2 Diabetes Mellitus In The United Kingdom — Romita Das ...
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Patient Characteristics Associated With Initiation Of Insulin Glargine Among Patients With Type 1 Or Type 2 Diabetes Mellitus In The United Kingdom
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-04
Organisations:
Romita Das - Chief Investigator - Merck Sharp & Dohme - UK
Jinan Liu - Corresponding Applicant - Janssen US
Berhanu Alemayehu - Collaborator - Merck & Co., Inc.
Gail Fernandes - Collaborator - Merck & Co., Inc.Outcomes:
To assess the prescription pattern of glargine and other types of insulin, the primary outcome is the first type of insulin drug prescribed during the index period. Specifically, the study will consider all types of insulin drugs: Rapid-acting: lispro (Humalog, Liprolog); aspart (NovoMix, NovoRapid); glulisin (Apidra) Short-acting: insulin human Intermediate-acting: NPH (isophane insulin) Long-acting: insulin glargine; insulin detemir; insulin degludec
Description: Technical Summary
The objective of the study is to describe prescription patterns of insulin, the characteristics of patients initiating insulin glargine in real-world clinical practices and potential factors associated with the initiation of insulin glargine. Patients with insulin initiation between Jan 1st 2009 to Dec 31st 2013 will be included in this study. Patients will be required to have at least one year information before the initiation date (index date) and at least 90 days after index date. The primary outcome is to assess the prescription pattern of glargine and other types of insulin; the primary outcome is the first type of insulin drug prescribed during the index period. Logistic regressions will be conducted to identify the baseline characteristics associated with Glargine initiation versus the other insulin.
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Androgen Deprivation Therapy for Prostate Cancer and the Risk of Hospitalisation for Community-Acquired Pneumonia — Samy Suissa ...
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Androgen Deprivation Therapy for Prostate Cancer and the Risk of Hospitalisation for Community-Acquired Pneumonia
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-27
Organisations:
Samy Suissa - Chief Investigator - McGill University
Blánaid Hicks - Collaborator - Queen's University Belfast
Christina Santella - Collaborator - McGill University
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill UniversityOutcomes:
Hospitalisation for community-acquired pneumonia
Description: Technical Summary
Androgen deprivation therapy (ADT) is the mainstay treatment in patients with advanced prostate cancer. However, this therapy has been associated with a number of adverse events, including cardiovascular outcomes and fractures. Studies also suggest that ADT may increase the risk of pneumonia, but these have a number of methodological shortcomings. Thus, the objective of this study is to assess whether the use of ADT (including gonadotropin-releasing hormone (GnRH) agonists, oral antiandrogens, and bilateral orchiectomy) is associated with an increased risk of community-acquired pneumonia. This objective will be addressed by assembling a cohort of patients newly-diagnosed with non-metastatic prostate cancer between April 1, 1998 and March 31, 2015. Time-dependent Cox proportional hazard models will be used to estimate adjusted hazard ratios and 95% confidence intervals for a hospitalisation for community-acquired pneumonia (recorded in the Hospital Episode Statistics) associated with current and past use of ADT, compared with no use. Secondary analyses will assess if the risk varies according duration of use, and by specific types of ADT.
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Towards An Understanding Of Persistence, Switching, And Adherence With Medications For Over-Active Bladder:A Retrospective Observational Study In UK Clinical Practice — Florent Guelfucci ...
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Towards An Understanding Of Persistence, Switching, And Adherence With Medications For Over-Active Bladder:A Retrospective Observational Study In UK Clinical Practice
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-05
Organisations:
Florent Guelfucci - Chief Investigator - Creativ-Ceutical
Florent Guelfucci - Corresponding Applicant - Creativ-Ceutical
Adrian Wagg - Collaborator - University of Alberta
Amine Khemiri - Collaborator - Creativ-Ceutical
Ashley Jaggi - Collaborator - Astellas Pharmaceuticals
Francis Fatoye - Collaborator - Manchester Metropolitan University
Jameel Nazir - Collaborator - Astellas Pharmaceuticals
Zalmai Hakimi - Collaborator - Astellas PharmaceuticalsOutcomes:
The primary endpoint of this study will be the persistence during 12 months of follow-up, defined as the time from initiation of OAB therapy to the discontinuation of OAB therapy.
Description: Technical Summary
The overall objectives of this study will be to compare the persistence and adherence (assessed by medication possession ratio [MPR]) of patients with overactive bladder (OAB) receiving mirabegron vs. antimuscarinic (AM) drug therapies; provide a description of these patients; understand whether persistence and adherence as clinical endpoints have health resource implications in standard UK clinical practice.
A retrospective analysis of patients starting a new OAB drug between 01 May 2013 and 30 June 2014 will be conducted using the Clinical Practice Research Datalink GOLD. Patients will be categorised as naive to OAB therapy or having prior therapy, depending on the prescription of other OAB drugs within a 12-month look-back period. The observation period will be 12 months. Adherence will be measured using the medication possession ratio (MPR) and non-adherence will be defined as an MPRâ¤80%. Persistence will be defined as the duration of uninterrupted OAB therapy.
For each population, we will provide descriptive statistics on patient baseline characteristics, persistence/adherence, resource utilisation and costs. Time to discontinuation and MPR will be compared between index OAB drugs using adjusted regression models. To minimise allocation bias comparative groups will be matched on gender; age; comorbidity and treatment status (naïve/experienced) to prior antimuscarinic treatment.
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Risk of stroke following discontinuation of oral anticoagulant treatment for atrial fibrillation: a cohort study — Carlos Martinez ...
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Risk of stroke following discontinuation of oral anticoagulant treatment for atrial fibrillation: a cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-04
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Ben Freedman - Collaborator - ANZAC Research Institute
Christopher Wallenhorst - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)Outcomes:
Incident strokes occurring during the study period after AF diagnosis
Description: Technical Summary
Objectives
The objective is to estimate the risk of stroke in patients with atrial fibrillation (AF) who are initially treated with vitamin K antagonists (VKAs), comparing patients discontinuing VKAs with those currently using VKAs.
Methods
This will be a population-based cohort study in patients treated with VKAs for AF, analysed using a nested case-control approach. The cohort of patients with an incident AF treated with VKAs will be identified from the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES). For each patient with a stroke during the observational period (cases), controls without a stroke will be selected from the VKA-treated AF cohort. Strokes will be identified from CPRD, HES and Office of National Statistics (ONS) mortality data.
Data analysis
The relative risk of VKA discontinuation compared to VKA continuation with regard to stroke will be estimated from crude and adjusted odds ratios (ORs) derived from conditional logistic regression for matched caseâcontrol data using current VKA use as the reference category.
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Stability of blood eosinophils in COPD and controls and the impact of eosinophil count, age, gender and smoking status — Frank de Vries ...
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Stability of blood eosinophils in COPD and controls and the impact of eosinophil count, age, gender and smoking status
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-05
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Anke-Hilse Maitland-van der Zee - Collaborator - University of Amsterdam
Dionne Braeken - Collaborator - Utrecht University
Frits Franssen - Collaborator - CIRO
Miel (Emiel) Wouters - Collaborator - CIRO
Olorunfemi Oshagbemi - Collaborator - Utrecht University
Yvonne Henskens - Collaborator - Maastricht UniversityOutcomes:
Stability of blood eosinophil count
Description: Technical Summary
Rationale: Chronic Obstructive disease is an inflammatory disease which is known to affect the airways of the lungs. Pathophysiology of the disease is mediated by release of macrophages, eosinophils, neutrophils , cytokine, and CD8+ lymphocytes. Peripheral eosinophil counts are increasingly recognised as a biomarker for response to inhaled corticosteroids in COPD and may assist in better targeting treatments to patients who will benefit most. However, little is known about the long-term stability of blood eosinophils in COPD and the impact of age, gender and eosinophil counts. Greater understanding of this subject area can help gain better understanding needed to tailor COPD treatments to specific patient groups, potentially reducing the cost of managing the disease and increasing the chance of improved outcomes.
Objective: The study therefore aims to determine the stability of blood eosinophil counts in COPD patients and non-COPD patients.
Methods: The primary outcome will be the stability of blood eosinophil count, with stability defined as a count remaining persistently at <2% or >/= 2%. Patients will be followed until end of study period, or when defined as unstable ("failure"). Kaplan Meier curves will be plotted to show eosinophil stability, stratified by eosinophil counts at baseline age groups, gender, and smoking status.
Source - and 17 more projects — click to show
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Sequelae of gastrointestinal infections: incidence, risk factors, and economic impact on primary and secondary care settings. — Rafael Perera ...
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Sequelae of gastrointestinal infections: incidence, risk factors, and economic impact on primary and secondary care settings.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-05
Organisations:
Rafael Perera - Chief Investigator - University of Oxford
Oluwaseun Esan - Corresponding Applicant - University of Oxford
Alastair Gray - Collaborator - University of Oxford
Mara Violato - Collaborator - University of Oxford
Noel McCarthy - Collaborator - Health Protection Agency - HPA
Oluwaseun Esan - Collaborator - University of Oxford
Thomas Fanshawe - Collaborator - University of OxfordOutcomes:
Reactive Arthritis, Irritable Bowel Syndrome, GP consultations, Laboratory tests, Referrals, Prescriptions, Gastrointestinal hospital admission, Guillain-Barre Syndrome, Sepsis, Rheumatoid arthritis, Crohn's disease, Ulcerative colitis, Inflammatory Bowel Disease, Death
Description: Technical Summary
The purpose of this research is to determine the incidence of sequelae following common GI infections, associated risk factors and the economic impact across primary and secondary healthcare settings. Sequelae of interest include reactive arthritis (ReA) and irritable bowel syndrome (IBS), both commonly diagnosed in primary care; rare complications such as Guillain-Barre Syndrome (GBS), sepsis and Crohn's disease, commonly diagnosed in secondary care; and extraintestinal manifestations such as rheumatoid arthritis. To address this, we will conduct a retrospective cohort study of linked primary care, secondary care, death and deprivation data from 2000-2015 to describe the incidence of sequelae following infection with non-typhoidal Salmonella (NTS) and Campylobacter in England. We will test the hypothesis that use of certain classes of antibiotics (quinolones, macrolides and cephalosporins) and acid-reducing drugs are associated with the development of complications. Additionally, we will quantify resource use and associated costs across healthcare settings. The results from this study will provide more robust estimates of the incidence of sequelae following GI infections, the effect of associated risk factors and the economic burden, thereby informing current strategies to reduce exposure to infection and allocate resources efficiently.
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Trimethoprim and sudden death in patients over 65 years with urinary tract infection — Laurie Tomlinson ...
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Trimethoprim and sudden death in patients over 65 years with urinary tract infection
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-28
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Crellin - Corresponding Applicant - The Health Foundation
Adrian Root - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Clémence Leyrat - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Pascal Frey - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Pascal Frey - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Timo Smieszek - Collaborator - NOAA - National Oceanic and Atmospheric Administration
Timo Smieszek - Collaborator - NOAA - National Oceanic and Atmospheric AdministrationOutcomes:
Death within 14 days of antibiotic exposure Hospitalisation for acute kidney injury (AKI) Hyperkalaemia
Description: Technical Summary
We aim to investigate the association between trimethoprim and sudden death. We will identify a cohort of all patients over 65 during the period April 1997 to September 2015.
To test whether trimethoprim is associated with sudden death, we will use logistic regression, adjusting for potential confounders, to estimate the odds ratio of sudden death following antibiotic prescription for trimethoprim compared to amoxicillin, nitrofurantoin, ciprofloxacin, or cefalexin. To limit confounding by antibiotic indication we will restrict the analysis to patients with antibiotic prescription for urinary tract infection. We will also examine whether diabetes mellitus, and ACEI/ARB or potassium-sparing diuretic therapy, modify the effect of trimethoprim on sudden death.
We will investigate acute kidney injury and hyperkalaemia (proposed as causal mechanisms for sudden death in this context) as secondary outcomes. We will examine the robustness of our results through sensitivity analyses. In a further analysis we will use propensity scores to ensure exposure groups are comparable.
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Unsupervised clustering and topological analysis of Type-2 Diabetes and prediabetes patients in CALIBER using clinical data from electronic medical records — Juan Pablo Casas Romero ...
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Unsupervised clustering and topological analysis of Type-2 Diabetes and prediabetes patients in CALIBER using clinical data from electronic medical records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-18
Organisations:
Juan Pablo Casas Romero - Chief Investigator - University College London ( UCL )
Mustafa Ghafouri - Corresponding Applicant - University College London ( UCL )
Anoop Shah - Collaborator - University College London ( UCL )
David Prieto-Merino - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jorge Garcia-Hernandez - Collaborator - University College London ( UCL )
Juan M Garcia-Gomez - Collaborator - Technical University of Valencia
Ketan Patel - Collaborator - Astra Zeneca Inc - USA
Sajan Khosla - Collaborator - Astra Zeneca Ltd - UK Headquarters
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
The outcome for objective one will be the identified clusters and their group membership. Subsequent outcomes to be compared include mortality and complications associated with Type-2 Diabetes (including kidney disease, diabetic retinopathy, diabetic neuropathy microvascular complications and macrovascular complications). Macrovascular and microvascular complications have previously been phenotyped by Anoop et, al. using CPRD data as part of CALIBER.
Description: Technical Summary
Precision medicine is a new branch of treatment that considers the variability in genetics and clinicopathological architecture of a disease when considering the clinical management of different patients. One recent study utilised a data driven approach using Electronic Health Records (EHR's) to understand Type-2 Diabetes by identifying distinct clusters of patients. Each cluster was characterised by different clinicopathological phenotypes as well as a distinct genetic architecture.
This project proposes a similar analysis using unsupervised topological analysis on the CALIBER dataset (CArdiovascular research using Linked Bespoke studies and Electronic health Records), a research platform of linked EHR's and administrative data providing rich data on comorbidities and treatments, a large number of clinical variables for cluster analysis and a large sample size of patients.
The identified clusters can then be compared for their clinical and demographic characteristics and visualised using topology. Multinomial logistic regression is used to identify which clinical variables are most important in determining clusters and cox regression to identify possible differences between clusters for prognosis and long term outcomes such as cardiovascular disease. This would demonstrate a clearer understanding and better management of different groups of patients diagnosed with Type-2 Diabetes in the UK.
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Comparison of Health Economic Outcomes for Patients with Asthma who switch from Seretide to flutiform or Fostair using the CPRD-HES Linked Database — Catrina Richards ...
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Comparison of Health Economic Outcomes for Patients with Asthma who switch from Seretide to flutiform or Fostair using the CPRD-HES Linked Database
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-31
Organisations:
Catrina Richards - Chief Investigator - IQVIA Ltd
Catrina Richards - Corresponding Applicant - IQVIA Ltd
Alison Young - Collaborator - Napp Pharmaceutical Group
Caroline O'Leary - Collaborator - IQVIA Ltd
Janette McQuillan - Collaborator - IQVIA ( IMS Health ) FranceOutcomes:
Outcomes of interest captured in the primary care setting will include: Number/average number of prescriptions of SABA usage, Number/average number of prescriptions of oral steroid usage, Number/average number of prescriptions of ICS usage, Number/average number of asthma-related GP visits. Outcomes of interest captured in the secondary care setting will include: Number/average number of asthma-related hospital visits, by type of visit.
Description: Technical Summary
The objective of this study is to compare healthcare utilisation between patients with asthma who switched from Seretide Evohaler to flutiform versus those who switched from Seretide Evohaler to Fostair in both the primary healthcare setting, and the secondary care setting. This study will be conducted using a retrospective cohort design using the Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES). The CPRD will be used for comparisons in primary care, looking at the number of asthma-related GP visits pre- and post-switch for both treatment arms, as well as the number of prescriptions for short-acting beta agonists (SABA), oral steroids and inhaled corticosteroids (ICS). Hospital Episodes Statistics (HES) data will be used for comparisons in secondary care, looking at the number of asthma-related hospitalisations pre- and post-switch for both treatment arms. In addition, the factors described above will be stratified by the dose from which patients switched, and the dose to which they switched (where sufficient patients exist).
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Can Novel Integrated Risk Schemes Change Treatment Decisions and Improve Health Outcomes in the Year after a Diagnosis of Atrial Fibrillation? An Individual-Based Simulation — Morris Weinberger ...
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Can Novel Integrated Risk Schemes Change Treatment Decisions and Improve Health Outcomes in the Year after a Diagnosis of Atrial Fibrillation? An Individual-Based Simulation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-31
Organisations:
Morris Weinberger - Chief Investigator - University of North Carolina at Chapel Hill
Todd Durham - Corresponding Applicant - IQVIA - USA (Headquarters)
Anthony Viera - Collaborator - University of North Carolina at Chapel Hill
Jason Fine - Collaborator - University of North Carolina at Chapel Hill
Jayanti Mukherjee - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Kristen Hasmiller Lich - Collaborator - University of North Carolina at Chapel Hill
Stacie Dusetzina - Collaborator - University of North Carolina at Chapel HillOutcomes:
The primary outcome will be quality-adjusted life months (QALMs). The secondary outcomes are the events that are used to derive QALMs: initial clinical events (stroke, intracranial hemorrhage, extracranial hemorrhage, and death), death within 30 days following an initial non-fatal clinical event, all-cause deaths.
Description: Technical Summary
Treatment decisions in atrial fibrillation are often guided by risk stratification for stroke and bleeding, but the existing risk models have a number of limitations. We sought to address these limitations in an earlier study by developing new risk prediction models for the first competing events of stroke, intracranial hemorrhage, extracranial hemorrhage, and death. Our new models performed well in terms of discrimination and calibration. However, it is not known if our new models could change treatment decisions and impact subsequent health outcomes. The goal of this study is to evaluate the potential clinical usefulness of our new risk schemes using individual-based simulation. We will use data from a cohort of adult patients with incident atrial fibrillation to evaluate a number of treatment selection rules including current treatment patterns (patients are prescribed treatment we observed in the cohort). We will simulate health outcomes conditional on treatment and patient characteristics. Outcomes include stroke, intracranial hemorrhage, extracranial hemorrhage, death, death following an initially non-fatal event, all-cause deaths, and quality-adjusted life months. We will characterize the potential health impact of using our new models in treatment decisions through empirical confidence intervals about QALMs gained (primary) and mean events averted (secondary) versus current treatment patterns.
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Risk of major bleeds associated with the use of direct oral anticoagulants in venous thromboembolism — Samy Suissa ...
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Risk of major bleeds associated with the use of direct oral anticoagulants in venous thromboembolism
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-19
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Corresponding Applicant - McGill University
Brenda R Hemmelgarn - Collaborator - University of Calgary
Lisa Lix - Collaborator - University of Manitoba
Min Jun - Collaborator - University of Calgary
Pierre Ernst - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes:
Hospitalization or visit to the emergency department for a major bleed All-cause mortality
Description: Technical Summary
The objective of this study is to assess the safety of DOACs for the treatment of VTE using real-world, population-based data sources to inform policy development and clinical practice. We will conduct a matched cohort study to assess the safety of DOACs compared with vitamin K antagonists (VKA) such as warfarin among patients with incident VTE. The investigators will carry out separate population based cohort studies using administrative health databases in Canada, the United States (US), and the United Kingdom (UK). VKA-users will be matched to DOAC-users based on age, sex, date of cohort entry and propensity score. To determine the adjusted hazard of study outcomes with DOACs use (compared with VKA), we will perform multivariable Cox proportional hazards regression to estimate the hazard ratios and their corresponding 95% confidence intervals. Analyses will be performed separately at each of the participating CNODES sites according to a common analytical protocol and then pooled using meta-analysis.
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An analytical framework for increasing the efficiency and validity of research using primary care databases — Evangelos Kontopantelis ...
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An analytical framework for increasing the efficiency and validity of research using primary care databases
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-27
Organisations:
Evangelos Kontopantelis - Chief Investigator - University of Manchester
Evangelos Kontopantelis - Corresponding Applicant - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
David Reeves - Collaborator - University of ManchesterOutcomes:
Asthma, atrial fibrillation, cancer, coronary heart disease, chronic kidney disease, chronic obstructive pulmonary disease, dementia, depression, diabetes mellitus, epilepsy, heart failure, hypertension, hypothyroidism, learning disability, osteoarthritis, osteoporosis, severe mental illness, stroke, and Body Mass Index
Description: Technical Summary
Routinely collected electronic medical record (EMR) databases are rich sources of data for health research. Although lacking the rigour of Randomised Controlled Trials (RCTs) and potentially affected by bias from uncontrolled factors, these databases allow the investigation of research questions which may not be feasible to address by other means. The UK leads the world in Primary Care Databases (PCDs), which collate data from the electronic records of patients registered with large numbers of general practices, benefitting from the almost complete computerisation of UK primary care. Publications using PCDs and the Clinical Practice Research Datalink (CPRD) in particular attract global research interest and applications are becoming more sophisticated, and the demands made on the data greater, as the field develops. This work focuses on three problematic or under-developed aspects of PCD-based research studies: a) reducing duplication of effort; b) increasing validity and reproducibility; c) improving analysis methodologies. To address these issues we will develop and maintain an online repository and also develop methods and software to perform power calculations, extract data and impute missing data. Our aim to increase the efficiency and transparency with which PCD-based research is conducted and the validity of the findings resulting from that research.
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Age- and lifestyle-related chronic disease and causes of mortality among adults with cerebral palsy in the United Kingdom. — Jennifer Ryan ...
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Age- and lifestyle-related chronic disease and causes of mortality among adults with cerebral palsy in the United Kingdom.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-10
Organisations:
Jennifer Ryan - Chief Investigator - Brunel University
Jennifer Ryan - Corresponding Applicant - Brunel University
Christina Victor - Collaborator - Brunel University
Kimberly Smith - Collaborator - Brunel University
Mark Peterson - Collaborator - University Of Michigan
Nana Kwame Anokye - Collaborator - Brunel University
Neil O'Connell - Collaborator - Brunel University
Nicola Ryan - Collaborator - Hospital Clinico San Carlos
Silvia Liverani - Collaborator - Brunel UniversityOutcomes:
A first event of the following chronic diseases will be ascertained using a record of a Read code from the clinical file: type 2 diabetes mellitus, asthma, bronchitis, emphysema and other chronic obstructive pulmonary diseases, hypertensive diseases, ischaemic heart diseases, other heart diseases (including pulmonary embolism, heart failure, atrial fibrillation and flutter), falls, diseases of the digestive system, hearing impairment, cerebrovascular diseases, chronic pain, osteoarthritis, rheumatoid arthritis, depression and anxiety, dementia, osteoporosis, incontinence, cancers (i.e. oesophageal, colon, lung, breast, prostate), hearing impairment, and visual impairment. Medical resource utilisation will be determined using the following variables: - The overall primary care consultation rate will be calculated as the sum of all recorded consultations in primary care. Each consultation will be classified by consultation type and staff type using information from the Consultation file. - The overall rate of outpatient consultations will be calculated as the sum of all recorded outpatient appointments in the outpatient HES data. - The overall hospitalisation rate will be calculated as the sum of all recorded hospital admissions in the subpopulation of people with linked HES data. - The length of hospitalisation will be calculated by subtracting the admission date from the discharge date in the inpatient HES data. - The number of prescriptions issued will be obtained from the Therapy file. - The number of investigations ordered including pathology and diagnostic services will be obtained from the Test file. These will be grouped by investigation type. The cost associated with medical resource utilisation will be defined as follows: - Each primary care consultation will be assigned an average cost as listed in the Unit Cost of Health and Social Care 2010 from the Personal Social Services Research Unit. - Each outpatient visit will be allocated an outpatient tariff. - The cost of inpatient admissions will be calculated using NHS Reference Costs. - Each prescription will attributed a net ingredient cost from the corresponding year of the Prescription Cost Analysis. - Each investigation will be allocated a cost using NHS Reference Costs. Causes of death will be determined and grouped using ICD-10 chapter headings recorded in the ONS death register.
Description: Technical Summary
The aim of this study is to examine the prevalence of chronic diseases, medical resource utilisation and associated costs, and causes of mortality among adults with cerebral palsy (CP) in the UK. We will compare adults with CP and matched controls without CP. Chronic diseases of interest are type 2 diabetes mellitus, asthma, chronic obstructive pulmonary diseases, hypertensive diseases, ischaemic heart diseases, other heart diseases, cerebrovascular diseases, chronic pain, arthritis, depression and anxiety, dementia, osteoporosis, incontinence, cancers (i.e. oesophageal, colon, lung, breast, prostate), falls, diseases of the digestive system, hearing impairment, visual impairment. Medical resource utilisation will be identified as the number of primary care and outpatient consultations, the rate and length of hospitalisation, and number of prescriptions issued and investigations ordered. For each outcome, a regression model will be fitted, adjusting for covariates (body mass index, ethnicity, smoking status, alcohol consumption, marital status, education, income, level of disability, and level of physical activity). Overall mortality rates and mortality rates stratified by the most frequent ICD-10 chapter headings will be calculated. Standardised mortality rates will be calculated as a ratio of the observed number of deaths among adults with CP to the expected number of deaths in the general population.
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Androgen Deprivation Therapy and Risk of Dementia — Samy Suissa ...
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Androgen Deprivation Therapy and Risk of Dementia
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-04
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Armen Aprikian - Collaborator - McGill University
Farzin Khosrow-Khavar - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Soham Rej - Collaborator - McGill UniversityOutcomes:
To assess whether the use of ADT is associated with an increased risk of dementia
Description: Technical Summary
The association between androgen deprivation therapy (ADT), a mainstay treatment for advanced prostate cancer, and dementia is controversial. Thus, the objective of this study will be to use the Clinical Practice Research Datalink to assess whether the use of ADT is associated with an increased risk of dementia in a cohort of approximately 45,000 patients newly-diagnosed with prostate cancer. The use of ADT will be treated as a time-varying variable, with exposure lagged by one year for latency considerations and to minimize reverse causality. Time-dependent Cox proportional hazards model will be used to estimate adjusted hazard ratios (with 95% CI) of incident dementia associated with use of ADT when compared with non-use of ADT. This study will address an important safety question in an older population already at increased risk of dementia.
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Cancer and risk of herpes zoster - case-control study in the Clinical Practice Research Datalink — Krishnan Bhaskaran ...
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Cancer and risk of herpes zoster - case-control study in the Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-10
Organisations:
Krishnan Bhaskaran - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
All cancers and the following site-specific cancers: breast, colorectal, lung and prostate cancer.
Description: Technical Summary
The objective of the study is to investigate the association between having had a cancer diagnosis and future risk of herpes zoster (also known as shingles). The two diseases could plausibly be associated because both have associations with immune function, which may be further affected by cancer treatments. Recent US data suggested a substantial increase in zoster risk among people with a previous cancer diagnosis. Our aim is to investigate this further by looking at how "any cancer" and common site-specific cancers (breast, colorectal, lung, prostate) are associated with future zoster risk, adjusting for potential confounders. We will conduct a matched case-control study: all individuals with an incident zoster diagnosis will be identified and matched on age, sex and GP practice to people who are under follow-up in CPRD at the same time but have no history of zoster. Conditional logistic regression models will be used to examine associations between cancer and zoster, both unadjusted, and adjusted for a range of potential confounders. The temporal relationship between cancer and zoster will also be examined by categorising the time between cancer diagnosis and index date. The results will be of interest to people with a history of cancer, and may help to inform zoster vaccination policy.
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Proton pump inhibitor use and risk of developing Alzheimer's disease or vascular dementia — Christoph Meier ...
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Proton pump inhibitor use and risk of developing Alzheimer's disease or vascular dementia
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-24
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Patrick Imfeld - Corresponding Applicant - University of Basel
Michael Bodmer - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Duration of PPI/H2RA use Timing of the last PPI/H2RA prescription
Description: Technical Summary
The aim of this study is to explore the association between proton pump inhibitor (PPI) use and the risk of developing Alzheimer's disease (AD) or vascular dementia (VaD). We propose a case-control analysis using CPRD data between January 1998 and December 2015. The study population will consist of cases of well-defined incident AD or VaD within the study period, and a group of dementia-free control patients, matched to cases at a 1:1 ratio on age, sex, calendar time, general practice, and number of years of recorded history. We will quantify relative risk estimates (calculated as odds ratios) of developing AD or VaD in relation to duration and timing of previous PPI use (as the main exposure of interest). We will also analyse previous use of histamine-2 receptor antagonists (H2RAs), another group of acid-reducing drugs, as an indirect comparator. We will apply multivariable conditional logistic regression analyses to calculate odds ratios with 95% confidence intervals.
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Use and costs of primary care consultations and prescription medications in relation to body mass index in middle-aged UK women — Jane Green ...
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Use and costs of primary care consultations and prescription medications in relation to body mass index in middle-aged UK women
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-31
Organisations:
Jane Green - Chief Investigator - University of Oxford
Alastair Gray - Collaborator - University of Oxford
Benjamin Cairns - Collaborator - University of Oxford
Borislava MIHAYLOVA - Collaborator - University of Oxford
Seamus Kent - Collaborator - National Institute for Health and Clinical Excellence - NICE
Susan Jebb - Collaborator - University of Oxford
Valerie Beral - Collaborator - University of OxfordOutcomes:
Annual costs of primary care consultations and prescription medications issue
Description: Technical Summary
We will estimate the impact of overweight and obesity on use and costs of primary care consultations and prescription medications, overall and for different health conditions, among >100,000 women in the Million Women Study (MWS) who also have available CPRD data. For these women, annual estimates of costs and use of primary care consultations and prescriptions issued, overall and by BNF chapter, will be generated from recruitment into the MWS (1996-2001) to the end of CPRD follow-up or death; and will be related to body mass index (BMI) at MWS recruitment using generalized linear models, controlling for potential confounders like age, smoking, and socioeconomic status. Exclusion of women with known cancer and chronic obstructive pulmonary disease, and of early years of follow-up, will be considered to account for confounding by pre-existing disease. Estimates of the effects of overweight and obesity on primary care and prescription medication costs will be projected to the 2013 population of women aged 55 to 79 in England. This study is designed to complement similar analyses using secondary care data.
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Linaclotide Utilisation Study in the UK - Extended Feasibility Counts — Javier Cid ...
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Linaclotide Utilisation Study in the UK - Extended Feasibility Counts
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-11
Organisations:
Javier Cid - Chief Investigator - Evidera, Inc
Mireia Raluy Callado - Corresponding Applicant - Evidera, Inc
Selin Cooper - Collaborator - Evidera, Inc
Yan Bai - Collaborator - Allergan, IncOutcomes:
The primary outcome of this study is the number of patients receiving linaclotide, overall, by subgroup of interest.
Description: Technical Summary
IBS is a chronic, relapsing gastrointestinal condition characterised by abdominal pain, bloating and changes in bowel habits, categorised according to Rome III criteria based on the stool's characteristics into IBS-D, IBS-C and IBS-M. The prevalence of IBS varies depending on the diagnostic criteria used, ranging from 9.5% to 22.0% in the UK. Linaclotide is the first medicine authorised for the symptomatic treatment of moderate-to-severe IBS-C in adults in the EU. Use of linaclotide in certain population groups is not considered to be sufficiently documented in the linaclotide clinical development programme and the EMA has requested a drug utilisation study to be conducted in selected European countries, amongst them the UK. The aim of this study is to obtain counts of patients using linaclotide, especially in the population subgroups for which the use of linaclotide was not sufficiently documented in the clinical programme, which includes those under 18 years of age, the elderly, and patients with specific conditions. These will be used to inform on the feasibility of conducting a detailed post-authorisation safety study to describe the use of linaclotide in the UK.
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Safety study to quantify the risk of ulceration (including all sites of occurrence), and related events (including perforations, fistula, abscess and bleeding) and death among patients treated with nicorandil with and without diverticular disease — Sandra Guedes ...
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Safety study to quantify the risk of ulceration (including all sites of occurrence), and related events (including perforations, fistula, abscess and bleeding) and death among patients treated with nicorandil with and without diverticular disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-03
Organisations:
Sandra Guedes - Chief Investigator - Merck Healthcare KGaA (Merck Group)
Sandra Guedes - Corresponding Applicant - Merck Healthcare KGaA (Merck Group)
Juergen Zieschang - Collaborator - Merck & Co., Inc.
Sampada Gandhi - Collaborator - Genzyme - Sanofi Company
Shinichi Matsuda - Collaborator - Merck & Co., Inc.
Ulrike Gottwald-Hostalek - Collaborator - Merck Healthcare KGaA (Merck Group)Outcomes:
Perforations, Ulcer, Fistula, Abscesses, Erosions, Diverticulosis, Diverticulitis, Death, Delayed wound healing, Hemorrhages. Outcomes of interest have been identified using READ codes.
Description: Technical Summary
The purpose of this study is to quantify the time-related risk and patterns of erosions, ulcerations, perforations, haemorrhages, abscesses, fistulae, delayed wound healing in patients treated with nicorandil (including gastrointestinal, skin, ocular, mucosal, anal; alone or in multiple locations), and death; together with the exploration of high risk subgroups, other risk factors, and a dose and time effect assessment.
This is a retrospective cohort study using the UK CPRD database. The inclusion criteria will be: patients aged 18 and older, with a diagnosis of angina pectoris between 01/01/1995 and 31/12/2014, and an initial prescription for Nicorandil. They will be longitudinally followed-up until end of observation period or death. Exposure will be determined individually for each patient. Outcomes of interest will include Perforation, Ulcer, Fistula, Abscess, Erosion, Diverticulosis, Diverticulitis, Death, Delayed wound healing, haemorrhages (PUFAEDH). Standard descriptive statistics, Kaplan-Meier time to event assessment and Cox proportional hazards modelling will be used. The main outcomes will be the incidence rates and 95% confidence intervals for the outcomes of interest, as stratified by variables. Additional descriptive analyses will be provided for specific subgroups, i.e. patients with discontinuation with and without treatment restart, and patients with sequence of events suggesting progression or reversibility.
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Profiling the natural history of Crigler-Najjar syndrome using the Clinical Practice Research Datalink — Christopher Morgan ...
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Profiling the natural history of Crigler-Najjar syndrome using the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-06
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Adam Hamm - Collaborator - American Statistical Association
Alexander Cole - Collaborator - Alexion Pharmaceuticals
Derek Dunn - Collaborator - Alexion Pharmaceuticals
Judith Campagnari - Collaborator - Alexion Pharmaceuticals
Leonardo Sahelijo - Collaborator - Alexion Pharmaceuticals
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Susana (Susan) Sobolov - Collaborator - Alexion PharmaceuticalsOutcomes:
a) Gender, age, location (based on the UK nation or English strategic health authority region in which the patient's primary care practice is located) b) CNS type. There are no classification codes to distinguish between CNS1 and CNS2, therefore we will use the decision rules outlined in Table 1. c) Age at first presentation d) Changes in diagnosis, that is the recording of other similar conditions such as Gilbert's disease e) Investigative procedures (liver biopsy, genotyping) f) Biochemistry - Serum bilirubin g) Family history based on siblings/parents with CNS sharing CPRD family number (patient histories will be compared to reduce the risk that patients are linked by shared accommodation only) h) Age when CNS treatment initiated by transfusion, phototherapy, phenobarbital i) Frequency of inpatient, outpatient and primary care contacts j) All therapeutics used for treatment or management purposes, and reasons for the therapies (based on ICD-10 or Read code) (from CPRD database only) k) Age at liver transplant l) Age at death; cause of death.
Description: Technical Summary
We aim to define a cohort of patients with Crigler-Najjar syndrome (CNS) and create patient profiles of relevant characteristics to determine, firstly, CNS type (CNS1 or CNS2) and, secondly, to follow the natural history of the condition. Data will be selected from CPRD, including linked HES inpatient and outpatient data and ONS mortality data. Patient profiles will be constructed for patients with relevant Read or ICD-10 codes including demographics, age at diagnosis, treatment pathways, longitudinal change in bilirubin values, rates of inpatient, outpatient and primary care contacts, and mortality and liver transplant rates.
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Incidence and risk factors for paediatric acute kidney injury in the UK — Dorothea Nitsch ...
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Incidence and risk factors for paediatric acute kidney injury in the UK
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-13
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Alasdair Henderson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Collaborator - University of TsukubaOutcomes:
Hospitalisation for acute kidney injury Frequency of childhood deaths
Description: Technical Summary
We will identify all those children (aged 18 years or under on 31st March 2015 â the last day of linked primary care and hospital record data coverage) registered with general practices in the Clinical Research Practice Datalink (CPRD). We aim to investigate the awareness and coding of AKI in children over time, the risk factors for paediatric AKI, and death following AKI in children.
The study will have two phases: i) descriptive; and ii) analytical. In the descriptive phase, in all children hospitalised during the study period, we will compare the ratio of hospitalisations with an AKI record to other paediatric hospitalisations for each year of the study, and also compare the descriptive characteristics of those hospitalised with an AKI record to those without. In children meeting strict eligibility criteria we will calculate the annual overall age and sex adjusted incidence rate of paediatric AKI, and also stratify annual results by age and sex. In the analytical phase, we will conduct a nested case-control study comparing paediatric AKI cases with age, sex and GP practice matched controls to investigate the risk factors for AKI in children. To investigate outcomes following AKI we will compare childhood death rate in cases and controls.
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Longitudinal Analyses of Body Mass Index and Risk of Parkinson's Disease in CPRD — Nawab Qizilbash ...
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Longitudinal Analyses of Body Mass Index and Risk of Parkinson's Disease in CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-07-19
Organisations:
Nawab Qizilbash - Chief Investigator - OXON Epidemiology - Spain
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
John Gregson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michelle Johnson - Collaborator - Roche
Neil Pearce - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Stephen Evans - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Stuart Pocock - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
The relationship between BMI and the chance of developing Parkinson's disease
Description: Technical Summary
The prevalence of Parkinson's disease is increasing and establishing modifiable risk factors of Parkinson's disease is a national and global priority. Currently, the relationship between BMI and the risk of developing Parkinson's disease is unclear. Previous research suggests that people who are overweight or obese may have a higher risk of developing Parkinson's disease than people with normal weight, while other studies show no such association. The objective of this study is therefore to investigate the association between BMI and risk of Parkinson's disease. A cohort will be derived from CPRD of people aged 40 years or older with a first BMI recording between 1992 and 2007. People with a prior record of Parkinson's disease or dementia will be excluded. Incidence rates of Parkinson's disease will be calculated for each BMI category using Poisson regression, adjusting for differences in patient characteristics. This study will provide information from a very large number of people with a sizeable amount of follow-up data which will be representative of the UK population. The findings will therefore provide important information to help clarify the relationship between BMI and Parkinson's disease to inform preventative strategies for Parkinson's disease.
Source
2016 - 06
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Characterisation and cardiovascular risk profile of type 2 diabetes mellitus patients according to initiation of antidiabetic medications — Karolina Andersson Sundell ...
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Characterisation and cardiovascular risk profile of type 2 diabetes mellitus patients according to initiation of antidiabetic medications
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; Patient Level Townsend Score; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-28
Organisations:
Karolina Andersson Sundell - Chief Investigator - Astra Zeneca R&D Molndal Sweden
Betina Blak - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Lucia Soriano - Collaborator - University Complutense of Madrid
Marcus Thuresson - Collaborator - Statisticon AB
Nikita Arya - Collaborator - Clinical Solutions Group
Niklas Hammar - Collaborator - Astra Zeneca Inc - USA
Peter Fenici - Collaborator - Astra Zeneca Inc - USAOutcomes:
Cardiovascular disease outcomes (fatal and non-fatal) Hospitalisation for specific CVD events Heart failure Myocardial infarction Stroke Transient ischaemic attack Unstable angina Multi-vessel coronary artery disease All-cause mortality Cardiovascular mortality
Description: Technical Summary
The objective of this retrospective cohort study using the Clinical Practice Research Datalink (CPRD) database is to provide a characterisation of patients with type 2 diabetes mellitus (T2DM) according to initiation (index date) of antidiabetic medications including sodium glucose co-transporter-2 inhibitors (SGLT-2), dipeptidyl peptidase-4 inhibitors (DPP-4), sulphonylureas (SU), glucagon-like peptide-1 agonists (GLP-1) and other standard of care (SOC) treatments from November 1st, 2012 until last date of observation. The study will also describe the crude incidence rate of cardiovascular (CV) outcomes and mortality rate in the study cohorts. Outcomes will include hospitalisation for heart failure (HF), myocardial infarction , stroke, transient ischaemic attack (TIA), unstable angina and multi-vessel coronary artery disease; all-cause mortality and CV mortality. Propensity scores will be calculated to assess comparability between SGLT-2 users and groups of potential comparators. This is to assess the feasibility of conducting the next step; a potentially comparative study between SGLT-2 users and a suitable control group. The descriptive analyses will be performed overall, by antidiabetic medication, by matched comparator groups and a subset of patients with established CV disease. A descriptive comparison of CV outcomes/mortality between SGLT-2 users and propensity score matched comparator groups will be performed.
Source -
Pharmacoepidemiology of pancreatin use in non-cystic fibrosis patients and comparison of all-cause mortality with that of their matched controls — Chris D Poole ...
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Pharmacoepidemiology of pancreatin use in non-cystic fibrosis patients and comparison of all-cause mortality with that of their matched controls
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-28
Organisations:
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Andres Diaz Ramirez - Collaborator - Mylan Inc (closed)
Bridgitte Kalsch - Collaborator - Mylan Inc (closed)
Christian Bannister - Collaborator - Digital Health Labs Limited
Hans-Friedrich Koch - Collaborator - Mylan Inc (closed)
Harald Schrem - Collaborator - Hannover Medical School
Johannes-Matthias Lohr - Collaborator - Karolinska Institute Sweden
Keith J Roberts - Collaborator - University Hospital Bristol
Michael Kirby - Collaborator - The Prostate Centre
Nils Ewald - Collaborator - Justus-Liebig University GiessenOutcomes:
The risk of all-cause mortality (ACM) following first-line Creon pancreatin monotherapy with that of matched non-pancreatin-treated PEI or matched diabetic controls respectively
Description: Technical Summary
The proposed research will study the pharmacoepidemiology and long-term outcomes associated with Creon pancreatin use in subgroups of patients with pancreatic exocrine insufficiency (PEI) due to aetiologies other than cystic fibrosis and diabetes. Within these subgroups we aim to compare the outcomes of Creon pancreatin-treated cases with non-pancreatin-treated matched controls.
The first part of the proposed research will be descriptive in nature. We aim to describe the therapeutic indications associated with Creon pancreatin therapy; preceding and concomitant treatments; clinical events &/or tests, and treatment pathways which are related/associated to/with Creon pancreatin prescription. The annual prevalence and incidence of PEI within the study observation period will be determined.
Following this we aim to compare the risk of all-cause mortality (ACM) following first-line Creon pancreatin monotherapy with that of matched non-pancreatin-treated PEI or matched diabetic controls respectively. Baseline characteristics will be evaluated to help determine the generalisability of the study population to other populations. Non-parametric univariate analysis of time to ACM will be performed using the Kaplan-Meier (KM) method. Dependent on the data, time to ACM will be modelled using either semi-parametric or parametric multivariate survival models.
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What is the occurrence of clinically diagnosed coeliac disease and dermatitis herpetiformis in the UK today? A population based cohort study utilising electronically linked health records. — Colin Crooks ...
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What is the occurrence of clinically diagnosed coeliac disease and dermatitis herpetiformis in the UK today? A population based cohort study utilising electronically linked health records.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-20
Organisations:
Colin Crooks - Chief Investigator - University of Nottingham
Harmony Otete - Collaborator - University Of Central Lancashire
Joe West - Collaborator - University of NottinghamOutcomes:
Prevalence of incidence of coeliac disease Prevalence and incidence of dermatitis herpetiformis Number of people with coeliac disease that are previously misdiagnosed with irritable bowel syndrome or functional abdominal pain
Description: Technical Summary
There is a consistent 1% serological prevalence of Coeliac disease across the UK that was not changing over time. However, our previous study up until 2011 found a rising incidence of the disease and a wide regional variation. We do not know whether the rise in incidence of clinical diagnosis has continued or whether the regional variation has improved.
Moving to areas of improvement, our previously conducted case control study of prior diagnosis of Irritable Bowel Syndrome (IBS) in coeliac cases compared to controls, found an almost four fold excess of IBS diagnoses prior to a coeliac diagnosis compared to controls, suggesting a delay to the diagnosis of coeliac disease. Equally we do not know if diagnostic delay is an ongoing issue and how actively clinicians seek to avoid misdiagnosis.
Using the most up to date data available, this study will update our previous work on trends and variations in the occurrence of coeliac disease and DH and re-assess whether misdiagnosis of Coeliac disease in the UK is continuing. We will first estimate the prevalence and incidence of coeliac disease and dermatitis herpetiformis in the UK from 2011 to 2015 inclusive. Secondly, we will determine the number of people with coeliac disease previously diagnosed with either irritable bowel syndrome (adults) or functional abdominal pain (children).
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Estimating the risk of acute kidney injury associated with use of diuretics and renin angiotensin aldosterone system blockers in CPRD — Fergus Caskey ...
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Estimating the risk of acute kidney injury associated with use of diuretics and renin angiotensin aldosterone system blockers in CPRD
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-05
Organisations:
Fergus Caskey - Chief Investigator - University of Bristol
Kate Tilling - Collaborator - University of Bristol
Penny Whiting - Collaborator - University of Bristol
Theresa Redaniel - Collaborator - University of Bristol
Tim Jones - Collaborator - University of Bristol
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes:
Incidence of Acute Kidney Injury
Description: Technical Summary
The overall aim of the study is to determine whether the incidence of acute kidney injury (AKI) in patients with chronic conditions (hypertension, heart disease, diabetes and kidney disease) is related to prescribing of diuretics and/or renin angiotensin aldosterone system (RAAS) blockers. We will assess a cohort of patients with the aforementioned chronic conditions who are registered in the Clinical Practice Research Datalink (CPRD), and have taken RAAS blockers, diuretics, and/or a combination of these medications (exposed) and patients who have not taken any of these medications (unexposed). We will conduct Cox regression to determine the association between receiving a prescription of diuretics and/or RAAS blockers with the risk of AKI, and propensity score matching, prior event rate ratio and instrumental variables analyses to adjust for unmeasured confounding.
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Diabetes, use of metformin and the risk of meningioma — Christoph Meier ...
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Diabetes, use of metformin and the risk of meningioma
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-20
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Collaborator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Michael Leitzmann - Collaborator - University of Regensburg
Peter Hau - Collaborator - University of Regensburg
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Ulrich Bogdahn - Collaborator - University of RegensburgOutcomes:
The association between diabetes, use of metformin, and risk of meningioma
Description: Technical Summary
Using data from the CPRD, we intend to perform a matched case-control analysis to explore the association between diabetes, use of metformin, and risk of meningioma. Cases will be individuals with an incident diagnosis of malignant meningioma between 1995 and 2015, younger than 90 years of age. Ten control patients will be matched to each case on age, sex, calendar time, general practice, and number of years of active history in the CPRD prior to the index date.
Relative risks will be estimated by conducting conditional logistic regression analyses to determine odds ratios (ORs) with 95% confidence intervals (CIs). Analyses will be adjusted for covariates determined to be potential confounders, (those that alter the risk of meningioma by >10%).
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Immunosuppressive therapy and Parkinson's disease risk — Caroline Williams...
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Immunosuppressive therapy and Parkinson's disease risk
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-21
Organisations:
Caroline Williams-Gray - Chief Investigator - University of Cambridge
Carol Brayne - Collaborator - University of Cambridge
Catherine Saunders - Collaborator - University of Cambridge
Kirsten Scott - Collaborator - University of Cambridge
Rupert Payne - Collaborator - University of BristolOutcomes:
Incident diagnosis of Parkinson's disease occurring at least 6 months (180 days) after the first prescription of immunosuppressive therapy.
Description: Technical Summary
Parkinson's disease (PD) is a neurodegenerative disorder which affects movement and walking as well as cognition, leading to considerable disability. The underlying pathology involves deposition of alpha-synuclein aggregates within the brain and neuronal loss, particularly within dopaminergic networks. However, immune activation is also well described in PD, both in the brain and the periphery, and may contribute to disease initiation and progression. Hence we will investigate whether immunomodulatory drugs alter PD risk, a question which has important implications for the use of such drugs as novel disease-modifying agents to slow disease progression. However there are challenges in addressing this question using epidemiological data, as both exposure to these drugs and the outcome of PD are relatively rare, and those on immunosuppressive therapy will have significant comorbidity which may be a confounding factor. The first phase of this work will therefore involve a descriptive study of the demographic and clinical characteristics of all cases within the CPRD database exposed to immunosuppressive drugs, as well as PD incidence in this cohort. We will use the data to determine the feasibility of a comparative cohort study and subsequently identify an appropriate control cohort and relevant confounding factors for this comparative study.
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Eligibility for Lung volume reduction surgery for COPD in the UK — Jennifer Quint ...
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Eligibility for Lung volume reduction surgery for COPD in the UK
Datasets:GP data, HES Admitted Patient Care; HES Diagnostic Imaging Dataset; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-28
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Campbell - Collaborator - CPRD
Nicholas Hopkinson - Collaborator - Imperial College LondonOutcomes:
Distribution of people who may be eligible for assessment for LVRS. Prevalence of LVRS eligibility Proportion of these who have documented exclusions (pulmonary hypertension, continued smoking) Proportion of these who have taken part in pulmonary rehabilitation within the last year or ever. Proportion who have had a CT scan in last 3 years Proportion who have been admitted to hospital with an acute exacerbation of COPD in the last 3 years Proportion who have a COPD patient unsuitable for pulmonary rehabilitation code.
Description: Technical Summary
As a national sample of current practice, we will use linked CPRD GOLD data with HES and ONS to undertake a cohort study to provide an accurate estimate of the number of people with COPD who may be eligible for LVRS or other LVR procedures. This will be based on measures of disease severity, breathlessness and comorbidity and whether they have taken part in pulmonary rehabilitation. We will also establish whether there is evidence that they have had a CT scan (using HES DID). Participation in pulmonary rehabilitation and hospital admission will be recorded to see if these events could be used as a trigger for LVRS assessment. The information obtained from this study will be used to inform the development of models and strategies to improve access to this form of treatment and reduce health inequality which can then be used as a national resource.
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Oral anticoagulants for atrial fibrillation and the risk of fractures — Samy Suissa ...
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Oral anticoagulants for atrial fibrillation and the risk of fractures
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-15
Organisations:
Samy Suissa - Chief Investigator - McGill University
Adi Klil-Drori - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Collaborator - McGill University
Laurent Azoulay - Collaborator - McGill UniversityOutcomes:
The composite of rib, wrist, hip, and spine fractures identified in HES.
Description: Technical Summary
The objective of this study is to examine fracture risk with the use of oral anticoagulants for stroke prevention in patients with atrial fibrillation. We will assemble a cohort of patients newly-diagnosed with atrial fibrillation between 1998 and 2015 using the Clinical Practice Research Datalink (CPRD) with linkage to the Hospital Episode Statistics (HES) and the Office for National Statistics (ONS). Cohort entry will be defined by the date of atrial fibrillation diagnosis, as determined by Read codes in CPRD. Primary exposure will be defined in a time-dependent fashion as current use of vitamin K antagonists (VKA) or direct oral anticoagulants (DOACs), separately, and the reference group will be the use of antiplatelet drugs. The primary outcome will be the first hospitalization with a diagnosis of rib, spine, hip or wrist fracture, identified in HES by international classification of diseases-10 codes. Time-dependent Cox models will be used to assess the hazard ratio for hospitalized osteoporotic fractures associated with current use of VKA or DOACs, compared with antiplatelet use. Secondary analyses will include duration-response analyses of fracture risk with VKA and DOAC use, stratification of patients by age and history of osteoporosis, and stratification of the outcome by fracture type.
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A retrospective database study of the prescribing of zonisamide in UK general practice: a drug utilisation study as part of post marketing safety surveillance. — Louise Watson ...
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A retrospective database study of the prescribing of zonisamide in UK general practice: a drug utilisation study as part of post marketing safety surveillance.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-08
Organisations:
Louise Watson - Chief Investigator - Explore-Epi
Louise Watson - Corresponding Applicant - Explore-Epi
Luigi Giorgi - Collaborator - Eisai Pharmaceuticals
Ruth Farquhar - Collaborator - ExploristicsOutcomes:
Drug utilisation of zonisamide in UK general practice
Description: Technical Summary
As part of European risk mitigation strategies for zonisamide (Zonegran), Eisai has committed to a drug utilization study in the paediatric population >/=6 years and </=17 years of age in the UK. The European Medicines Agency (EMA) has requested a database study in order to evaluate whether recommendations in the zonisamide "Summary of Product Characteristics (SmPC)" regarding dosing and risk mitigation strategies are being adhered to by general practitioners, who undertake routine prescribing for paediatric epileptic patients.
This study, conducted in the Clinical Practice Research Datalink (CPRD) from October 1st 2013 until March 31st 2016 (or last available data in 2016) will report the age range and clinical background of paediatric patients prescribed the drug, including weight, height and BMI. Diagnosed co-morbidities pre and post exposure to zonisamide will be reported, as well as laboratory data for serum bicarbonate levels which should be monitored. Additionally, the concomitant prescribing of other carbonic anhydrase inhibitors with the same mechanism of action as zonisamide and prescribing of anticholinergic drugs which are both contra-indicated will be evaluated. Results will be submitted as part of the Clinical Safety Report (CSR) and fulfilment of the post approval measure as reported in the Sections III.2 and III.4 of the Risk Management Plan (RMP).
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GLP-1 agonists and the risk of breast cancer in patients with type 2 diabetes — Samy Suissa ...
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GLP-1 agonists and the risk of breast cancer in patients with type 2 diabetes
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-13
Organisations:
Samy Suissa - Chief Investigator - McGill University
Samy Suissa - Corresponding Applicant - McGill University
Blánaid Hicks - Collaborator - Queen's University Belfast
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Collaborator - McGill University
Michael Pollak - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Robert Platt - Collaborator - McGill UniversityOutcomes:
Primary diagnosis of breast cancer (malignant and carcinoma in situ)
Description: Technical Summary
Recent evidence from preclinical studies and randomised controlled trials suggest that GLP-1 agonists may increase the risk of breast cancer. However, to date, no observational study has investigated this potential safety issue. Thus, the objective of this study will be to assess this association by assembling a cohort of female patients who initiated a new antidiabetic drug class on or after January 1, 2007 until March 31, 2015. All patients will be followed until a first-ever diagnosis of breast cancer, or censored upon death, end of registration with the practice, or end of the study period (March 31, 2016). Time-dependent Cox proportional hazard models will be used to estimate hazard ratios and 95% confidence intervals of breast cancer associated with the use GLP-1 agonists when compared with the use of DPP-4 inhibitors, with exposures lagged by 1 year for latency purposes. Secondary analyses will assess whether the risk varies according to cumulative duration of use and time since initiation. This study will provide the concerned stakeholders with the necessary information to assess the risks and benefits of these therapies.
Source - and 14 more projects — click to show
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Three months versus 28 day prescriptions: a retrospective analysis of CPRD data to determine differences in the cost of drug wastage, dispensing fees and prescriber time — Edward Wilson ...
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Three months versus 28 day prescriptions: a retrospective analysis of CPRD data to determine differences in the cost of drug wastage, dispensing fees and prescriber time
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-20
Organisations:
Edward Wilson - Chief Investigator - University of Cambridge
Brett Doble - Corresponding Applicant - University of Cambridge
Rupert Payne - Collaborator - University of Bristol
Sarah King - Collaborator - University of CambridgeOutcomes:
The five case study conditions are: 1) glucose control in type II diabetes (patients receiving at least one prescription for an anti-diabetic drug listed under ?BNF 6.1.2 Antidiabetic drugs?); 2) primary prevention of hypertension in type II diabetes (in addition to receiving an anti-diabetic drug as defined in (1), patients receiving at least one prescription for a medication used for the primary prevention of hypertension in type II diabetes patients, including angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, calcium-channel blockers and thiazide-like diuretics); 3) primary prevention of hyperlipidaemia in type II diabetes (in addition to receiving an anti-diabetic drug as defined in (1), patients receiving at least one prescription for a statin used for the primary prevention of hyperlipidaemia in type II diabetes patients; 4) secondary prevention of myocardial infraction (in addition to receiving concurrent prescriptions for a angiotensin-converting enzyme inhibitor, antiplatelet and statin for at least one year in duration, patients may also receive prescriptions for beta-adrenoceptor blockers, calcium-channel blockers, oral anticoagulants and aldosterone antagonists); 5) depression (patients receiving at least one prescription for an anti-depressant drug listed under BNF 4.3 Antidepressant drugs).
Description: Technical Summary
The aim of this study is to estimate the differences in the costs of drug wastage, dispensing fees and prescriber time as a result of early refills and treatment switches in patients receiving medications as either 28-day or 3-month supplies for a number of common chronic diseases. A retrospective cohort analysis will be conducted using data from a random sample of 50,000 patients for five case study conditions derived from all adult patients receiving at least one prescription relevant to the respective condition during the 10-year period between 2004 and 2014. The volume of wastage from early refills and treatment switches (defined as a repeat prescription or new prescription for a drug commonly prescribed for the same condition being issued prior to the expiry of the previously prescribed quantity) will be estimated. Unit costs from standard sources will be applied to estimate the cost of wastage and dispensing for a common price year. The cost of health professional time to issue the prescription will also be added. Changes in drug wastage and dispensing fees will then be estimated had all prescriptions been for 28 days rather than the observed length.
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PASS in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic — CRISTINA REBORDOSA GARCIA ...
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PASS in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Admitted Patient Care; HES Admitted Patient Care; HES Admitted Patient Care; ONS Death Registration Data; ONS Death Registration Data; ONS Death Registration Data; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-01
Organisations:
CRISTINA REBORDOSA GARCIA - Chief Investigator - RTI Health Solutions
CRISTINA REBORDOSA GARCIA - Corresponding Applicant - RTI Health Solutions
Anita Tormos - Collaborator - RTI Health Solutions
Anouk Deruaz Luyet - Collaborator - Boehringer-Ingelheim International GmbH
David Martinez - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Kenneth Rothman - Collaborator - RTI Health Solutions
Kimberly Brodovicz - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Lawrence Rasouliyan - Collaborator - RTI Health Solutions
MANEL PLADEVALL - Collaborator - RTI Health Solutions
Soulmaz Fazeli Farsani - Collaborator - Boehringer-Ingelheim International GmbH
Susana Perez-Gutthann - Collaborator - RTI Health SolutionsOutcomes:
Acute liver injury Acute liver injury in a subset of patients without predisposing factors Acute kidney injury Chronic kidney disease Hospitalisation for severe complication of urinary tract infection (pyelonephritis and urosepsis) Outpatient severe complications of urinary tract infections Occurrence of genital infection Hospitalisation or systemic treatment for genital infections Hospitalisation due to diabetic ketoacidosis
Description: Technical Summary
The objective of this study is to evaluate the liver and renal safety of empagliflozin as well as the incidence of urinary tract and genital infections. This will be an observational cohort study among adult patients with T2D and at least 12 months of continuous enrolment in the CPRD in which new users of empagliflozin will be compared to new users of other SGLT2 inhibitors and to new users of DPP 4 inhibitors. Propensity scores based on information prior to the index date (date of initiation of medication of interest) will be used to account for potential confounding. The study will estimate crude and adjusted incidence rates (IR) and adjusted incidence rate ratios (IRR) of the primary and secondary outcomes. The primary outcomes will be: acute liver injury (ALI), acute kidney injury (AKI), hospitalisation due to severe complications of urinary tract infection (UTI), and genital infections. The secondary outcomes will be: ALI in a subset of patients without predisposing factors, chronic kidney disease, outpatient severe complications of UTI, and genital infections resulting in hospitalisation or systemic treatment. Data from the Hospital Episodes Statistics (HES) and Office of National Statistic (ONS) mortality will also be used to identify potential cases.
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Use of parenteral corticosteroids and risk of type 2 diabetes mellitus. — Frank de Vries ...
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Use of parenteral corticosteroids and risk of type 2 diabetes mellitus.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-13
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
A Keyany - Collaborator - Sint Maartenskliniek
Bart JF van den Bemt - Collaborator - Sint Maartenskliniek
Johannes T.H. Nielen - Collaborator - Utrecht UniversityOutcomes:
Cases will be defined as patients with a new onset of T2DM. A patient with a record of a NIAD will be defined as case in this study.
Description: Technical Summary
The objective is to evaluate the risk of new onset type 2 diabetes mellitus among patients using parenteral corticosteroids (intraarticular/intrabursal/periarticular/intramuscular/intradermal). Within the CPRD, all patients (at least 18 years of age) who have their first ever prescription record for a non-insulin antidiabetic drug (NIAD) recorded will be selected as cases.. To each T2DM patient, one control patient (no T2DM) without a NIAD or insulin prescription during the entire study period will be selected using incidence density sampling, and will be matched by year of birth, sex, and GP practice. Use of parenteral CS will be determined by reviewing dispensing information before index date. Conditional logistic regression analysis will be used to estimate the risk of T2DM therapy associated with use of parenteral CS and the various confounding variables.
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The association between bariatric surgery and renal outcomes — Ian Douglas ...
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The association between bariatric surgery and renal outcomes
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-15
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachel Batterham - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Uwe Koppe - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Baseline Renal Function - will be defined as: i) best of two: the highest eGFR from the most recent two serum creatinine results recorded in the 12 months prior to index and separated by a minimum of three months (three month timeframe chosen to correspond to the requirement for eGFR to remain at a consistent level of impairment for at least three months in order for a patient to be diagnosed at a specific CKD stage); or ii) if only one suitable creatinine result is available, the single most recent serum creatinine recorded prior to baseline. eGFR threshold - Renal function will be defined using serum creatinine test results to calculate estimated glomerular filtration rate (eGFR) using the CKD-EPI equation. CKD - As for eGFR threshold, but also requiring a second measure of eGFR <60 at least three months later. Acute kidney injury - will be defined as the first episode of AKI identified within 28 days of the start of a hospital admission identified using ICD-10 morbidity coding in HES, to capture cases of AKI that were present at hospital admission but may have not been immediately diagnosed, without excluding cases that resulted in a prolonged admission. We will use a previously validated code list.
Description: Technical Summary
We will investigate the association between bariatric surgery and renal outcomes in obese people in the United Kingdom, focusing on: i) reaching a threshold level of renal function; ii) incidence of chronic kidney disease; and iii) incidence of acute kidney injury. To achieve this we will look at people who receive bariatric surgery, based on their CPRD record, and compare them with people who are also obese but did not receive bariatric surgery. Outcomes will be defined using estimated glomerular filtration rate (calculated using CPRD serum creatinine results) and evidence of hospitalisation due to acute kidney injury using Hospital Episode Statistics (HES). Propensity score matching will be used to achieve comparability between the surgery and non-surgery group to help us deal with potential confounding. Cox regression will then be used to compare how often the outcomes occur in each group, resulting in a hazard ratio for each outcome.
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Cataract in patients with diabetes mellitus — Christoph Meier ...
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Cataract in patients with diabetes mellitus
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-05
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Corresponding Applicant - University of Basel
Annette Beiderbeck - Collaborator - Takeda Europe Ltd
Cornelia Schneider - Collaborator - University of Basel
David Neasham - Collaborator - Amgen Ltd
John Hall - Collaborator - IQVIA
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Incidence rates of cataract in patients with a diabetes diagnosis Hazard ratio of cataract associated with a diabetes diagnosis Odds ratio for cataract associated with diabetes duration, HbA1c, exposure to antidiabetic drugs
Description: Technical Summary
The study aims to describe the incidence of cataract in patients with diabetes mellitus in the UK and compare it (stratified by age, sex and year of diagnosis) to a random sample of the general (non-diabetic) population. Furthermore, we will calculate incidence rates of cataract in subpopulations of patients with diabetic retinopathy or macular edema.
We will use COX proportional hazards modelling (adjusted for age, gender and index year of diabetes diagnosis) to assess time to cataract in newly diagnosed diabetic patients.
Additionally, we will carry out a nested case-control analysis in diabetic patients with or without cataract to identify risk factors for cataract development. We will perform conditional logistic regression analysis using SAS software.
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A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases — Catrina Richards ...
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A Joint Drug Utilisation Study (DUS) of valproate and related substances, in Europe, using databases
Datasets:GP data, Pregnancy Register
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-02
Organisations:
Catrina Richards - Chief Investigator - IQVIA Ltd
Peter McMahon - Corresponding Applicant - IQVIA Ltd
Birgit Ehlken - Collaborator - IQVIA ( IMS Health ) France
Jacco Keja - Collaborator - IQVIA ( IMS Health ) France
Massoud Toussi - Collaborator - IQVIA ( IMS Health ) France
Stephanie Tcherny-Lessenot - Collaborator - Sanofi UKOutcomes:
The main analysis will compare the prescribing patterns of valproate during the pre- and post- implementation periods in females to meet the study objective. The analysis will be descriptive in nature. Descriptive statistics will be provided for the patients, treatments and diagnosis characteristics.
Description: Technical Summary
An assessment of the impact of dissemination of risk minimisation measures (i.e. educational materials and Dear Healthcare Professional Communication) and an assessment of these measures is planned. To meet the primary study objective, a main analysis will be performed on two 3-year periods before and after the implementation of risk minimisation measures, by subgroup of population (girls and women of childbearing potential). The main analysis will be descriptive and will provide information on demographics; medical history; valproate indication, dosage and duration; usage of medications related to any of the valproate indications; concomitant medications prescribed; hormonal contraceptives and IUD; co-morbidities; pregnancies.
Interim reports will be conducted every 6 months until the final report. An interrupted time series report will be considered for the final report if conditions are met in which data are evaluated at multiple time points before and after an intervention in order to detect whether or not an intervention had a significantly greater effect than any underlying trend. Regression analysis will be used to define the trends of each proportion in pre- and post implementation periods. The angle between the trends will be calculated for the two periods to provide insights into the impact of the implementation.
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Using pharmacoepidemiology to test medications associated with altered risk of breast cancer progression identified from connectivity mapping — Chris Cardwell ...
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Using pharmacoepidemiology to test medications associated with altered risk of breast cancer progression identified from connectivity mapping
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-05
Organisations:
Chris Cardwell - Chief Investigator - Queen's University Belfast
Chris Cardwell - Corresponding Applicant - Queen's University Belfast
Fabio Liberante - Collaborator - Queen's University Belfast
Gayathri Thillaiyampalam - Collaborator - Queen's University Belfast
Ken Mills - Collaborator - Queen's University Belfast
Liam Murray - Collaborator - Queen's University Belfast
Shu-Dong Zhang - Collaborator - Queen's University BelfastOutcomes:
To determine if use of the identified medications after breast cancer diagnosis is associated with increased, or reduced, breast cancer-specific mortality
Description: Technical Summary
Background: Connectivity mapping is a novel bioinformatics technique linking gene expression data with expression events induced by medications. It therefore allows medications to be screened to assess carcinogenicity and anti-cancer properties. This connectivity map process has been implemented, using publically available gene expression datasets, to identify prescription medications (used for non-cancer purposes) that may alter risk of breast cancer progression.
Aims: To determine the association between use of the identified medications (from connectivity mapping) and breast-cancer specific mortality.
Methods: A cohort study will be conducted. Breast cancer patients will be identified from cancer registries. Candidate medication use will be determined from prescription records and cancer-specific mortality from ONS mortality records. Cox regression models (with medication use as a time-varying covariate) will be used to calculate hazard ratios (HRs), and 95% confidence intervals (95%CIs), for the association between candidate medication use after diagnosis and cancer-specific mortality after adjustment for potential confounders.
Potential: The study could identify (previously unrecognized) medications which increase the risk of breast cancer progression; current licensing of such medications may need to be reconsidered. This study also has the potential to identify licensed medications that reduce risk of breast cancer progression and warrant further study in clinical trials.
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β-blocker effects on the association of hypoglycaemia with cardiovascular and all-cause mortality — Kamlesh Khunti ...
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β-blocker effects on the association of hypoglycaemia with cardiovascular and all-cause mortality
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-08
Organisations:
Kamlesh Khunti - Chief Investigator - University of Leicester
Brian Thorsted - Collaborator - Novo Nordisk
Francesco Zaccardi - Collaborator - University of Leicester
Lise Lotte Nystrup Husemoen - Collaborator - Novo NordiskOutcomes:
CV events and all-cause mortality
Description: Technical Summary
The objective of this research is to assess the impact of cardioprotective drugs on the risk of cardiovascular disease in people with diabetes who experienced severe hypoglycaemic episodes. People experiencing hypoglycaemia are mainly at risk of arrhythmic disorders, and the effect of cardioprotective drugs on disarrhytmias is different (i.e., β-blockers vs ACE-inhibitors). Using HES- and ONS-linked data, we aim to assess whether the protective effects of β-blockers differ in subjects with and without previous hypoglycaemia. A nested case-control study design will be used for the analysis to estimate the risk of cardiovascular and all-cause death by exposure in people with and without a previous episode of severe hypoglycaemia (interaction analysis).
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Generalizability of Clinical Trial Results: Value of Individual Data versus Aggregate Data — Til Stürmer ...
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Generalizability of Clinical Trial Results: Value of Individual Data versus Aggregate Data
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-28
Organisations:
Til Stürmer - Chief Investigator - University of North Carolina at Chapel Hill
Til Stürmer - Corresponding Applicant - University of North Carolina at Chapel Hill
Jin-Liern Hong - Collaborator - University of North Carolina at Chapel Hill
Michelle Jonsson Funk - Collaborator - University of North Carolina at Chapel Hill
Nze Shoetan - Collaborator - Astra Zeneca Inc - USA
Robert LoCasale - Collaborator - Astra Zeneca Inc - USA
Sara Dempster - Collaborator - Astra Zeneca Inc - USA
Stephen Cole - Collaborator - University of North Carolina at Chapel HillOutcomes:
The primary end point is the occurrence of a first major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, or confirmed death from cardiovascular causes.
Description: Technical Summary
The objective of this study is to explore different approaches to generalize clinical trial results to the target population when only aggregate data or subgroup-specific results are available in either clinical trial or real-world data. We use data from the JUPITER trial and the CPRD, and examine the following three methods of generalizing the trial results. The first method is weighting methods based on predicted probabilities from multivariable models. For a given data source with aggregate data, we simulate a hypothetical cohort which is consisted of fake individual data, and apply these methods to standardize the JUPITER trial results to the CPRD population. We compare the estimates of generalized trial results based on individual data to the estimates based on aggregate data. The second is to estimate the absolute risk reduction for anticipated treatment effect in the target population. We calculate the cardiovascular risk in the CPRD patients without receiving statins, and multiply it by the relative risk reduction observed in the JUPITER trial. The third is to estimate the statin effect by computing a weighted average of the subgroup-specific treatment effect estimates in the JUPITER trial with weights from the population distributions of effect modifiers in the CPRD.
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Development of small population prevalence model for heart failure — Michael Soljak ...
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Development of small population prevalence model for heart failure
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-01
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Michael Soljak - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Martin Cowie - Collaborator - King's College London (KCL)
Roger Newson - Collaborator - Imperial College LondonOutcomes:
Heart failure
Description: Technical Summary
Heart failure is a common, long term condition of enormous public health importance, which causes significant morbidity and mortality and contributes significantly to NHS health care costs. In this project we will be developing a prevalence model for heart failure in the English population,[1] using CPRD as a new data source,. Read codes for doctor diagnosed heart failure will be used to extract all definite and possible cases of heart failure from the CPRD cohort and the prevalence at the end of each year and cumulative prevalence will be estimated. In addition to diagnostic Read codes entered in primary care electronic health records (EHRs) we will use other data to identify likely or possible cases of heart failure, including Hospital Episode Statistics (HES) ICD-10 diagnostic data linked to CPRD, and other clinical data including test, prescribing and symptom data. This model will then enable us to identify patients in addition to GP-diagnosed cases who possibly have heart failure but do not have a GP diagnosis. Logistic regression models will then be fitted to estimate risk factor odds ratios, which will then be converted using a well-established method to small population prevalence estimates with confidence intervals using corresponding local data on risk factors.
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Long-term severe non-dermatological outcomes in eczema — Sinead Langan ...
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Long-term severe non-dermatological outcomes in eczema
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-28
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sinead Langan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Julian Matthewman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Katrina Abuabara - Collaborator - University Of California, San Francisco
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Morten Schmidt - Collaborator - Aarhus University Hospital
Richard Silverwood - Collaborator - University College London ( UCL )
Sigrun Alba Johannesdottir Schmidt - Collaborator - Aarhus University HospitalOutcomes:
Associations between eczema and psychological diseases Associations between eczema and key medical outcomes
Description: Technical Summary
The objectives of this study are to use data from Clinical Practice Research Database (CPRD) and Hospital Episodes Statistics to examine associations between eczema and a range of serious medical outcomes which may be associated with inflammation.
Identifying people with eczema
Populations with eczema will be identified in CPRD using an algorithm currently being developed and validated comprising Read codes and therapies and /or using ICD-10 codes in linked HES data
Eczema and medical outcomes
Several categories of conditions have been hypothesized to be associated with eczema including psychiatric diseases, cardiovascular diseases, fractures and autoimmune diseases. There is a lack of longitudinal population-based data to support the associations.1-9 We will undertake a series of matched cohort studies assessing associations between eczema and each outcome. Specifically, we will assess the associations with psychological diseases and obesity in children and adults (separately) with eczema compared to individuals without eczema. We will also examine if adults with eczema have higher rates of fractures, lymphopenia and acute cardiovascular outcomes.13,34 We will use time-updated Cox regression to compute hazard ratios with 99% confidence intervals to assess the associations between eczema and each outcome. We will examine the robustness of our results using several sensitivity analyses.
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Assessment of Metformin Use Pattern in UK using CPRD — Panagiotis Mavros ...
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Assessment of Metformin Use Pattern in UK using CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-29
Organisations:
Panagiotis Mavros - Chief Investigator - Janssen Scientific Affairs, LLC
Jinan Liu - Corresponding Applicant - Janssen US
Huang Xingyue - Collaborator - Merck & Co., Inc.Outcomes:
Total number of metformin prescriptions Total metformin treatment days Rate of metformin non-adherence (PDC < 80%) Percentage of patients discontinued metformin Percentage of patients with sub-optimal dose
Description: Technical Summary
The primary aims to describe metformin use pattern in T2DM patients and the secondary objective is to evaluate factors associated with metformin non-adherence, discontinuation and sub-optimal dose. Exploratory analysis will be conducted to assess metformin use pattern in anti-hyperglycaemic agent(s) (AHA) naive T2DM patients initiating metformin in 2013. Study endpoints include metformin non-adherence, metformin discontinuation, and percentage of patients with sub-optimal metformin dose in the follow-up period (12-months following the index date-dispensing date of the first metformin prescription in 2013). Two multivariate logistic regression analyses will be conducted. One logistic model is to evaluate patient demographic and clinical factors associated with metformin non-adherence (proportion of days covered-PDC <80%) and another is to evaluate factors associated with sub-optimal metformin dose during the follow-up period. For metformin discontinuation, Cox proportional hazards regression model will be conducted to assess factors associated with discontinuation.
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Descriptive assessment of the Hospital Treatment Insights database and its link to the Clinical Practice Research Datalink for research on antibiotic dispensing in English hospitals — Joseph Kim ...
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Descriptive assessment of the Hospital Treatment Insights database and its link to the Clinical Practice Research Datalink for research on antibiotic dispensing in English hospitals
Datasets:GP data, Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-13
Organisations:
Joseph Kim - Chief Investigator - IQVIA - UK
Eleanor King - Collaborator - IQVIA ( IMS Health ) France
Elizabeth Williamson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laura Shallcross - Collaborator - University College London ( UCL )
Matthew Hankins - Collaborator - IQVIA - UK
Patrick Rockenschaub - Collaborator - University College London ( UCL )
Rachel Tham - Collaborator - IQVIA LtdOutcomes:
The primary outcome is the number of dispensed antibiotics of a list of clinically relevant antibiotics within the same Hospital Episode Statistics episode.
Description: Technical Summary
Due to the way in which data for Hospital Treatment Insights is collected, an absence of a dispensing record is not equal to there not having been a drug administered and there is need to quantify the extent to which this affects recording for different drugs. Thus, the usefulness of the full Hospital Treatment Insights database and the subset linked to the Clinical Practice Research Datalink for research on antibiotic dispensing in hospitals in England will be explored using descriptive statistics. We will calculate prevalence rates and 95% confidence intervals for demographic variables, diagnoses for clinical infectious syndromes and antibiotic dispensing to provide insight into the representativeness of the separate populations included in the two datasets. Variations will be explored by stratifying by calendar year, age, sex and type of antibiotic. Similar statistics will be used to further explore dispensing for community-acquired pneumonia and under-recorded individual-level dispensing will be quantified where possible. If time and sample sizes allow for it, the results will be compared to the same estimates for urinary tract infection, cellulitis and sepsis.
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The characteristics and treatment patterns of Parkinson's disease patients in the UK — Linda Kalilani ...
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The characteristics and treatment patterns of Parkinson's disease patients in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-06-13
Organisations:
Linda Kalilani - Chief Investigator - UCB BioSciences, Inc.
Linda Kalilani - Corresponding Applicant - UCB BioSciences, Inc.
Knut Mueller - Collaborator - UCB Pharma SA - UK
Mahnaz Asgharnejad - Collaborator - UCB BioSciences, Inc.Outcomes:
Each treatment line will be assessed for the following outcomes: augmentation, discontinuation, switching and censoring (representing treatment lines that continue to the date of censoring) as defined below. Augmentation: The outcome of a line will be Augmentation if the next line contains every PD medication present in the current line plus one or more PD medications in addition. Discontinuation: The outcome of a line will be Discontinuation if the current line contains every PD medication present in the next line plus one or more PD medications in addition. Switching: The outcome of a line will be Switching if the current line contains PD medications not present in the next line AND the next line contains PD medications not present in the current line. Censored: The outcome of a line will be Censored if it is the last line before the end of follow-up.
Description: Technical Summary
There is limited published data available on treatment patterns of patients with Parkinson's disease (PD). Variability of reimbursement policies and treatment guidelines limit the ability to generalize study results of treatment patterns across regions. The objective of the study is to describe the characteristics and treatment patterns of newly diagnosed adult PD patients in the United Kingdom. We will conduct a descriptive retrospective cohort study using the Clinical Practice Research Database linked to the Hospital Episode Statistics database from 01 January 2004 to 30 Septmber 2015. We will only include data from practices that are up to standard and use patients that satisfy our pre-specified inclusion and exclusion criteria. We will identify patients using the Read diagnostic codes for PD assigned by physicians and obtain information on medications using product codes from physician prescriptions. The follow-up period will be from date of diagnosis to the fourth treatment line. For each treatment line we will describe the name of medication, type of prescription (monotherapy versus polytherapy), duration, and outcome of the treatment line (discontinuation, continuation, augmentation and switching). Statistical analysis will be descriptive; continuous variables will be presented as means and standard deviation or median and interquartile ranges, while categorical variables will be presented as frequencies and percentages.
Source
2016 - 05
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Androgen Deprivation Therapy for Prostate Cancer and the Risk of Anaemia — Samy Suissa ...
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Androgen Deprivation Therapy for Prostate Cancer and the Risk of Anaemia
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-04
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Adi Klil-Drori - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Blánaid Hicks - Collaborator - Queen's University Belfast
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Lysanne Campeau - Collaborator - McGill UniversityOutcomes:
The outcome of interest is anaemia, defined as the first haemoglobin measurement <130 g/l during the follow-up period. Secondary outcomes will categorise anaemia into mild (129-110g/l), moderate (109-80g/l) and severe (<80g/l) anaemia, defined based on the WHO criteria
Description: Technical Summary
Androgen deprivation therapy (ADT) is the mainstay treatment in patients with advanced prostate cancer. However, this therapy has been associated with a number of adverse events, including cardiovascular outcomes and fractures. There is also some evidence that ADT may increase the risk of anaemia, but the studies assessing this possible risk were small and had a number of methodological shortcomings. Thus, the objective of this study is to assess whether the use of ADT (including gonadotropin-releasing hormone (GnRH) agonists, oral antiandrogens, and orchiectomy) is associated with an increased risk of anaemia. This objective will be addressed by assembling a cohort of patients newly-diagnosed with non-metastatic prostate cancer between April 1st 1998 and March 31st 2015, with at least one record for a haemoglobin level in the normal range (130-180 g/l) in the year prior to diagnosis. Time-dependent Cox proportional hazard models will be used to estimate adjusted hazard ratios and 95% confidence intervals for anaemia (defined as the first haemoglobin measurement below 130 g/l during follow-up) associated with current and past use of ADT, compared with no use. Secondary analyses will assess if the risk varies according duration of use, by specific types of ADT, and whether the risk is reversible upon ADT discontinuation.
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An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 36-months post launch — David Price ...
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An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 36-months post launch
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-09
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Elizabeth Gardener - Corresponding Applicant - Cambridge Research Support Ltd.
Jessica Martin - Corresponding Applicant - Wellcome Trust Sanger Institute
Andrew Cooper - Collaborator - Mundipharma Research Ltd
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Frank Andersohn - Collaborator - Frank Andersohn Consulting & Research Services
Joan Soriano - Collaborator - Research in Real Life ltd.( RiRl )
Karin Maria Thelen - Collaborator - Mundipharma Research LtdOutcomes: none known
Description: Technical Summary
This historical cohort study aims to evaluate adverse events, prescribing prevalence and patient characteristics of patients initiating on FP/FOR or other fixed-dose combination inhaled corticosteroid/long-acting beta-agonist (FDC ICS/LABA) therapies prescribed in the 36 months post launch of FP/FOR in the UK. This study will consider both licensed and off-label use of FP/FOR in comparison to licensed use of other FDC ICS/LABA therapies within the following subgroups of patients: patients â¥18 years with asthma, patients aged â¥12 years and <18 years with asthma, paediatric patients (aged 4â11 years) with asthma, patients with chronic obstructive pulmonary disease (COPD) (and no asthma) and patients prescribed ICS/LABA as the âmaintenance and reliever therapy (MART)â regimen. Patients included will have â¥1 prescriptions for any ICS/LABA fixed-dose combination from 2012. Prescribing prevalence of FP/FOR and other FDC ICS/LABAs in the CPRD will be evaluated for each of the subgroups. Adverse events and patient characteristics will be compared between patients initiating on FP/FOR and other FDC ICS/LABAs for each of the subgroups. The design consists of baseline and outcome periods of 12 months each, either side the index date (date at which patients initiate on any FDC ICS/LABA therapy).
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Mortality recording in the Clinical Practice Research Datalink — Arlene Gallagher ...
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Mortality recording in the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-10
Organisations:
Arlene Gallagher - Chief Investigator - CPRD
Arlene Gallagher - Corresponding Applicant - CPRD
Daniel Dedman - Collaborator - CPRD
Frank de Vries - Collaborator - Utrecht University
Hubert Leufkens - Collaborator - Utrecht University
Shivani Padmanabhan - Collaborator - Not from an OrganisationOutcomes: none known
Description: Technical Summary
The primary aim of this study is to evaluate the death date information available through CPRD. Information on the date of death will be used from multiple sources: the transfer out date in CPRD (where the reason is given as âDeathâ), the date of death recorded in the Additional Clinical Details, the death date generated by the CPRD algorithm, the date specified in the ONS mortality data and death information from the linked HES. Sensitivity and specificity of the CPRD death algorithm will be evaluated compared to the gold-standard ONS death registration data. Annual and age-specific mortality rates will be calculated including various sources of death data and eligible populations, standardising to the European Standard Population.
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Health Care Utilisation, Care Pathways and Educational Status in Children and Young People with Adolescent Mental Health Disorders — Ann John ...
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Health Care Utilisation, Care Pathways and Educational Status in Children and Young People with Adolescent Mental Health Disorders
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-10
Organisations:
Ann John - Chief Investigator - Swansea University
Ann John - Corresponding Applicant - Swansea University
Alison Kemp - Collaborator - Cardiff University
Ashley Akbari - Collaborator - Swansea University
Bethan Carter - Collaborator - Cardiff University
Melissa Wright - Collaborator - Cardiff University
Sarah Rees - Collaborator - Cardiff University
Sophie Wood - Collaborator - Cardiff UniversityOutcomes:
Healthcare utilisation by children and young people with adolescent mental health disorders with focus on Self-harm Anxiety Depression Eating disorders
Description: Technical Summary
This healthcare assessment for adolescents with mental health disorders has three priorities to explore:
⢠the interface between different care settings for example primary and secondary care and health and social care
⢠the quality of care provision
⢠transition between children and adult services.These objectives will be addressed by linking routinely collected healthcare data (such as Hospital statistics, GP data, mental health datasets, socio-demographics) and mapping the healthcare utilisation of adolescents with mental health disorders. Data will be presented for key questions in simple graphical form for trends across age groups, gender, time and deprivation (where possible). Direct standardised rates for age related populations will be calculated and compared. Comparison between countries will be made where possible using appropriate statistical methodologies. These are likely to include:
1. Variations for sub group populations Mantel-Haenszel risk ratios
2. Chi-squared tests to assess homogeneity of rates over time
3. Logistic regression to test for temporal linear trends
4. Cox regression survival analysis
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Development of an identification tool for patients over 65 years at risk of death or emergency hospital admission during cold weather. — Richard Morris ...
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Development of an identification tool for patients over 65 years at risk of death or emergency hospital admission during cold weather.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-17
Organisations:
Richard Morris - Chief Investigator - University of Bristol
Richard Morris - Corresponding Applicant - University of Bristol
Alastair Hay - Collaborator - University of Bristol
Claudio Sartini - Collaborator - University College London ( UCL )
Daniel Lasserson - Collaborator - University of Birmingham
Peter Tammes - Collaborator - University of BristolOutcomes:
1 - Death (with cause). Although all-cause mortality will be the primary focus, we will also assess death of cardiovascular disease (ICD10 codes I20-I25 and I60-I69) 2 - Emergency admission to hospital. Each emergency admission during the follow up period (ending at first emergency admission or 31st March 2014, whichever is earlier) to be ascertained for each patient.
Description: Technical Summary
Cold weather poses primary care challenges both for prevention and treatment of resulting morbidity. Approximately 24,000 extra deaths occur every winter in England & Wales, chiefly in older people: figures which will rise as the population ages. In March 2015, NICE recommended GPs should flag patients living in cold or hard to heat homes, but GPs currently have neither capacity to visit everyone nor tools to determine those at highest risk. This proposal will address this second issue, to help primary care teams focus resources towards those most likely to benefit. We will use CPRD, linked with Hospital Episode Statistics, to investigate predictors of emergency hospital admission and mortality following cold spells, and examine primary care contacts around such events. We will also link local weather data over the period of follow up to identify cold weather spells. This will allow precise estimation of risks associated with cold weather. We will investigate the degree and nature of contact with primary care during cold spells, both for patients who die or are admitted to hospital within 14 days, and other patients. Prediction equations will be built using a training set (randomly chosen half of the data) and tested in the remainder.
Source -
Discovering prognostic subtypes of cardiovascular diseases, using linked electronic healthcare records from 2 million people — Harry Hemingway ...
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Discovering prognostic subtypes of cardiovascular diseases, using linked electronic healthcare records from 2 million people
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-25
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Taavi Tillmann - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Amitava Banerjee - Collaborator - University College London ( UCL )
David Prieto-Merino - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Maria Pikoula - Collaborator - University College London ( UCL )
Riyaz Patel - Collaborator - Barts Health and UCLH NHS Trusts
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes:
Fatal outcomes: coronary heart disease death; cardiac arrest; other cardiovascular disease death; non-cardiovascular disease death Non-fatal outcomes: Cardiovascular disease states: stable angina; unstable angina; STEMI; NSTEMI; other coronary heart disease; transient ischaemic attack; ischaemic stroke; subarachnoid haemorrhage; intracerebral haemorrhage; other stroke; mitral valve disease; aortic valve disease; other valve disease; atrial fibrillation ; other conduction disorder; peripheral vascular disease; abdominal aortic aneurysm; heart failure ; miscellaneous cardiovascular diseases; Net use of healthcare services
Description: Technical Summary
Objectives: 1) To visualize the pathways through which individuals transition from full health to death, along intermediating cardiovascular diagnoses. 2) To use the visualization to identify potential prognostic subtypes. 3) To describe the predictors of these subtypes, especially the role of biomarkers and comorbidities/multimorbidity. 4) To evaluate the causality of any biomarkers identified.
Participants: Baseline participants (ca 2 million patients from CPRD, who at entry between 1997-2010 are aged 30+) are followed up for morbidity and mortality with CPRD, HES, ONS and MINAP databases, to identify 22 cardiovascular outcomes (including coronary, stroke, and arrythmic events) and one non-cardiovascular outcome (major haemorrhage).
Methods: 1-2) Alluvial diagrams will be used to describe the progression of participants from health to death. 3) Classical Cox survival models will be adapted to identify which predictors describe each subtype. 4) Mendelian Randomization will be applied to data (probably the UK Biobank) for causal inference.
We are not aware of previous work that used electronic healthcare record data, to identify subtypes of disease progression. Thus if our results are validated by future studies, it could hold methodological value in demonstrating the utility of these methods for analyzing large-scale EHR datasets to identify phenotypic subtypes of disease.
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Treatment choice and outcomes associated with dry powder inhaler and Tiotropium Respimat monotherapy in COPD (chronic obstructive pulmonary disease) patients — Anna Scowcroft ...
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Treatment choice and outcomes associated with dry powder inhaler and Tiotropium Respimat monotherapy in COPD (chronic obstructive pulmonary disease) patients
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-02
Organisations:
Anna Scowcroft - Chief Investigator - UCB Pharma Ltd
Alicia Gayle - Corresponding Applicant - Imperial College London
Alicia Gayle - Collaborator - Imperial College London
Andrew Ternouth - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Gavin Chiu - Collaborator - Boehringer-Ingelheim Pharmaceuticals, IncOutcomes: none known
Description: Technical Summary
This study is a non-interventional cohort study using existing data (CPRD), to gain detailed insights on the characteristics of COPD patients treated with a dry powder inhaler (DPI) or Respimat. So far large scale clinical trials have shown no significant differences in patient outcomes such as exacerbations/ FEV1 etc.. This may be due to patients in these trials being educated in optimal inhaler use and adhering more than expected in the general population in real life. In real world practice, where adherence and inhaler technique can vary- inhaler type may influence patient outcomes. The main objective is to compare outcomes between patients prescribed a DPI and Tiotropium Respimat maintenance monotherapy; exacerbation rate, time on monotherapy, time to treatment step up (addition of LABA or ICS), treatment adherence, change in lung function and health care resource use. The results from this study will be used to support the scientific understanding of how choice of device may influence COPD outcomes. Comorbidities and demographic information will be described for the groups of patients initiated on different therapies. Multivariate regression models will be used to compare outcomes between the two propensity-matched groups.
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Use of blood eosinophil count to predict inhaled steroid responsiveness in patients with COPD using primary care health records — Helen Ashdown ...
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Use of blood eosinophil count to predict inhaled steroid responsiveness in patients with COPD using primary care health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-31
Organisations:
Helen Ashdown - Chief Investigator - University of Oxford
Helen Ashdown - Corresponding Applicant - University of Oxford
Christopher Butler - Collaborator - University of Oxford
Emily McFadden - Collaborator - University of Oxford
Ian Pavord - Collaborator - University of Oxford
Margaret Smith - Collaborator - University of Oxford
Mike Thomas - Collaborator - University of Southampton
Mona Bafadhel - Collaborator - University of OxfordOutcomes:
Primary outcome: exacerbations of COPD (time-to-first exacerbation, as well as sensitivity analyses on number/year, and 2 exacerbations/year) Secondary related outcomes - Pneumonia, death (ONS), hospitalisation (HES), rate of decline in % predicted FEV1 per year.
Description: Technical Summary
This study will use a new user cohort design to assess outcomes for a group of COPD patients who have not previously been prescribed an inhaled corticosteroid (ICS-naive) and who then commence treatment with a new inhaled maintenance treatment (the index date). The descriptive component of the study will examine records of routine blood eosinophil testing in general practice and their values prior to starting a new inhaled maintenance treatment, their relationship to other baseline variables, and their stability over time. The hypothesis-testing component will test whether baseline blood eosinophil values predict disease outcomes, and outcomes under treatment (ICS responsiveness). The primary outcome will be acute exacerbations of COPD. Patients will be divided into two groups based on whether the new inhaled maintenance medication is an ICS or long-acting bronchodilator. Disease outcomes over time will be compared between those patients starting treatment with ICS and those starting treatment with a long-acting bronchodilator, with adjustment for baseline characteristics, and this will be stratified by baseline blood eosinophil values to determine whether this modifies effectiveness of treatment.
Source -
Development of small population prevalence models for COPD and asthma — Michael Soljak ...
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Development of small population prevalence models for COPD and asthma
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-09
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline - UK
Mahsa Mazidi - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
COPD and asthma are common, long term conditions of enormous public health importance. They cause significant morbidity and mortality and contribute significantly to NHS health care costs. There is good evidence of under-diagnosis in many practices, especially in urban areas.[1] In this project we will be updating, both in terms of data sources and methods, a previously developed prevalence model for COPD,[2] using CPRD as a new data source, and developing a new prevalence model for asthma, also using CPRD data. In addition to diagnostic Read codes entered in primary care electronic health records (EHRs) we will use other data to identify likely or possible cases including Hospital Episode Statistics (HES) ICD-10 diagnostic data linked to CPRD, and other clinical data including spirometry, prescribing and symptom data. Logistic regression models will then be fitted to estimate risk factor odds ratios, which will then be converted using a well-established method to small population prevalence estimates with confidence intervals using corresponding local data on risk factors.
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Estimation of multi-treatment effects from observational data with application to diabetes mellitus — Roee Gutman ...
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Estimation of multi-treatment effects from observational data with application to diabetes mellitus
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-16
Organisations:
Roee Gutman - Chief Investigator - Brown University
Roee Gutman - Corresponding Applicant - Brown University
David Dore - Collaborator - Optum
Robert Smith - Collaborator - Providence Veterans Administration Medical Center
William Hiatt - Collaborator - University Of ColoradoOutcomes:
Myocardial infarction, stroke, and hospitalization for heart failure
Description: Technical Summary
We will examine the performance of the methods by estimating effects of different antihyperglycemic drug regimens (mono- or poly-therapy) on the occurrence of myocardial infarction, stroke, and hospitalization for heart failure for diabetes mellitus patients. The design will consist of generalized propensity-score (GPS) matching based on pre-treatment covariates, with the primary method chosen via simulation work. This "as-matched" analysis based on the original exposure classifications has the advantage of preserving the randomization-like features of the GPS analysis. In this analysis, we will calculate incidence rates of acute myocardial infarction and use Kaplan-Meier plots to depict the cumulative probability of event-free time among the GPS matched cohorts (i.e., more than two).
Source - and 13 more projects — click to show
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The utilization and toxicity profile of oral corticosteroids among asthma patients in the UK: an epidemiological study using Data from the Clinical Practice Research Datalink (CPRD). — Christoph Meier ...
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The utilization and toxicity profile of oral corticosteroids among asthma patients in the UK: an epidemiological study using Data from the Clinical Practice Research Datalink (CPRD).
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-22
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Julia Spoendlin - Collaborator - University of Basel
Klaus Kuhlbusch - Collaborator - Roche
Liam Heaney - Collaborator - Queen's University Belfast
Marlene Rauch - Collaborator - University of Basel
Shih-Chen Chang - Collaborator - Pharmacyclics
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Bone related conditions; bone fracture, osteoporosis, Hypertension Peptic or esophageal ulcer, Severe infections requiring hospitalization, Herpes zoste,r Diabetes, Cataract, Glaucoma, Chronic kidney disease, Psychiatric events, Cardiovascular disease
Description: Technical Summary
We aim to perform a cohort study to quantify incidence rates of corticosteroid-related adverse effects in asthma patients with and without oral prednisone or prednisolone (the most commonly used oral corticosteroids, referred to as prednisolone in this protocol) use. In a matched (1:4) nested case-control analysis we will then quantify relative risk estimates (calculated as odds ratios) for prednisolone-related adverse effects, sub-classified into the duration of prednisolone use, continuous vs. burst use, the cumulative prednisolone dose (in continuous and burst users separately) and the average daily prednisolone dose in continuous users. We will apply multivariable conditional logistic regression analyses to calculate odds ratios with 95% confidence intervals. The proposed study is the first study to quantify corticosteroid-related adverse effects in asthma patients specifically, and which will differentiate between patients with burst use of oral prednisolone and of continuous oral maintenance therapy with prednisolone.
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A Drug Utilisation Study of Rifaximin 550mg — Jennifer Campbell ...
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A Drug Utilisation Study of Rifaximin 550mg
Datasets:GP data, Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-22
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Jennifer Campbell - Corresponding Applicant - CPRD
Bharat Amlani - Collaborator - Norgine
Hanna Sodatonou - Collaborator - NorgineOutcomes:
Rifaximin- 550mg is the exposure of interest, for which there is one gemscript code available in CPRD.
Description: Technical Summary
Rifaximin- is an antibacterial drug which has been marketed for many years as a 200mg tablet for various gastrointestinal infections such as travellers' diarrhoea. In November 2012, Norgine received decentralised procedure approval for rifaximin- (XIFAXAN/TARGAXAN) 550mg. This is a prescription-only medication that is used in adults with liver disease to reduce the recurrence of episodes of overt Hepatic Encephalopathy (HE). In January 2013, the UK was the first to launch the 550mg product in Europe. A drug utilisation study will be conducted in CPRD GOLD, IMS Disease Analyser Germany and the HTI-CPRD GOLD link to understand the dosing, the formulation, the indications and the patient demographics associated with rifaximin- 550mg tablets across the UK and Germany following launch in January 2013. Tables of descriptive data (including counts, mean, median, standard deviation and inter-quartile range) on each patient cohort will be presented. The aim of this analysis it to address three regulatory concerns about the new drug, interactions with other treatments, potential off label use for other indications and potential off label paediatric use.
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Are primary care factors associated with hospital admissions for adverse drug reactions among the population with type 2 diabetes? A national observational study — Michael Soljak ...
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Are primary care factors associated with hospital admissions for adverse drug reactions among the population with type 2 diabetes? A national observational study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-08
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
The objectives of this study are to:
1. Characterise the nature of ADR admissions, and drugs to which they are attributed, among individuals with type 2 diabetes (T2D),
2. Investigate primary care treatment factors (prescription of particular anti-diabetes drug classes and achievement of QOF indicators for diabetes) associated with ADR admissions due to drugs for diabetes
3. Develop a code list to identify ADRs recorded in primary care electronic health records (EHRs) of patients with T2D, and investigate the concordance of ADRS in HES and primary care EHRsIndividuals in CPRD with a diagnosis of T2D, > 18 years, and resident in England, will be included. The CPRD-linked inpatient Hospital Episode Statistics (HES) database will be used to identify outcomes (any ADR or hypoglycaemia admissions between 2005 and 2014 for the first objective, and hypoglycaemia admissions, or non-hypoglycaemia ADR admissions attributed to diabetes drug use, for the second). Data regarding treatment-related factors (treatment regime, and individual-level diabetes QOF indicator achievement) and potential confounders (including patient demographics, morbidity, BMI, smoking and alcohol use) will be drawn from CPRD.
ADR incidence rates will be reported by both nature of reaction and associated drug class.
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Does the use of inhaled corticosteroids increase the incidence and disease burden of Type 2 Diabetes, osteoporosis or pneumonia compared to non-ICS therapies in patients with Chronic Obstructive Pulmonary Disease. — David Price ...
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Does the use of inhaled corticosteroids increase the incidence and disease burden of Type 2 Diabetes, osteoporosis or pneumonia compared to non-ICS therapies in patients with Chronic Obstructive Pulmonary Disease.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-11
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Rosie McDonald - Corresponding Applicant - Research in Real Life ltd.( RiRl )
Andreas Clemens - Collaborator - NOVARTIS
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Emil Loefroth - Collaborator - NOVARTIS
Jeffrey Stephens - Collaborator - Swansea University
Joan Soriano - Collaborator - Research in Real Life ltd.( RiRl )
Nicolas Roche - Collaborator - University Paris Descartes
Richard Brice - Collaborator - Whitstable Medical Practice
Robert Brett McQueen - Collaborator - Research in Real Life ltd.( RiRl )
Robert Fogel - Collaborator - NOVARTIS
Rupert Jones - Collaborator - Plymouth UniversityOutcomes:
Type 2 Diabetes onset - is defined in this study as a diagnostic Read code for Type 2 Diabetes, and/or antidiabetic drug prescriptions and/or two or more HbA1c readings > 6.5%. Given the use of Metformin for polycystic ovary syndrome (PCOS), patients with a diagnosis of PCOS and a Metformin prescription will be excluded from the Type 2 Diabetes analysis. Type 2 Diabetes worsening disease control and disease progression - will be analyzed in the group of patients who have a diagnostic Read code for Type 2 Diabetes, and/or antidiabetic drug prescriptions and/or two or more HbA1c readings > 6.5% ever prior to index date. To ensure Metformin prescriptions for treatment of PCOS are not incorrectly counted as incidence of Type 2 Diabetes, patients with PCOS and a Metformin prescription ever prior to index date will be excluded. Worsening disease control will be measured by change in blood glucose level defined as increased glycated haemoglobin (HbA1c) readings. Disease progression will be measured by treatment change. Osteoporosis onset - is defined in this study as a diagnostic Read code for osteoporosis. Osteoporosis drug prescriptions without an accompanying diagnosis code will not be considered indicative of osteoporosis presence given commonly prescribed osteoporosis drugs are prescribed for other conditions and are used for osteopenia. Incidence of pneumonia - is defined as a Read code for pneumonia, with a chest X-ray or hospitalization code within 30 days of pneumonia diagnostic code. In primary care records, chest x-rays and hospitalisations will be identified by Read codes. In secondary care records, ICD-10 codes will be used. A pneumonia code within 4 weeks of the last will be counted as the same case of pneumonia. Overuse of ICS - is defined as ICS drugs prescribed to patients in GOLD groups A and B. Number of patients who are classified as GOLD category A or B with ICS prescriptions will be presented as a proportion of the total number of patients who are classified as GOLD categories A or B.
Description: Technical Summary
The objective is to analyze the relationship between ICS use and Type 2 Diabetes onset, Type 2 Diabetes worsening disease control and disease progression, osteoporosis onset, and incidence of pneumonia. A further objective is to measure overuse of ICS according to guidelines. Firstly, these endpoints will be compared between an ICS therapy cohort and non-ICS therapy cohort. Subsequently, they will be analyzed within the ICS-therapy cohort only and compared by average daily dose, cumulative dose, drug type and inhaler device type. A 1-year baseline period prior to the date of first prescription of ICS therapy or first/additional prescription of non-ICS therapy (i.e. the index date) will be followed by a minimum 1-year outcome period. All of the patient's available data post index date will be utilized. Summary statistics will be produced for unmatched and matched data for all baseline variables by group. Time to event outcomes will be analyzed using multivariable Cox proportional hazards models, reporting hazard ratios with 95% confidence intervals. Continuous progression outcomes will be analyzed using paired t-tests and generalized estimating equations reporting mean changes with 95% confidence intervals. Count outcomes will be analyzed using conditional Poisson regression, reporting incidence rate ratios with 95% confidence intervals.
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Burden of medically attended acute gastroenteritis and aetiology: a cohort study in CPRD in England. — Germano Ferreira ...
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Burden of medically attended acute gastroenteritis and aetiology: a cohort study in CPRD in England.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-16
Organisations:
Germano Ferreira - Chief Investigator - Not from an Organisation
Germano Ferreira - Corresponding Applicant - Not from an Organisation
Benjamin Lopman - Collaborator - Centers for Disease Control - CDC
Clarence Tam - Collaborator - National University of Singapore
John Harris - Collaborator - University of Liverpool
Kaatje Bollaerts - Collaborator - P95
Margarita Riera-Montes - Collaborator - P95
Thomas Verstraeten - Collaborator - P95
Tom Cattaert - Collaborator - P95Outcomes:
The outcome of interest is the occurrence of medically attended acute gastroenteritis (MAAGE) and medically attended norovirus gastroenteritis (MANGE) episodes with index date within the subject study follow-up (person-time at risk). MAAGE and MANGE episode A MAAGE episode is defined as a series of at least one MAAGE event with the lag time between successive events not exceeding 14 days. Hence, a recurrence with a lag time of more than 14 days will be considered as a new MAAGE episode. The episode index date is the date of the first MAAGE event of the MAAGE episode. MAAGE episodes will be classified as primary care-only or requiring hospitalization based on the level of care required over the course of the episode. Any episode containing at least one MAAGE event from HES Inpatient will be classified as requiring hospitalization. MAAGE episodes will be further classified according to aetiological cause, e.g. episodes related with Norovirus (MANGE), Rotavirus, Salmonella, Campylobacter, other Bacterial, Clostridium difficile, Parasitic. An algorithm will be developed with MAAGE experts to select a main cause for episodes with multiple cause-specific aetiologies recorded. MAAGE or MANGE associated death will be considered as deaths recorded in the ONS mortality linked data, for which MAAGE or MANGE were recorded as primary or contributory causes of death.
Description: Technical Summary
Infectious gastroenteritis is an important cause of morbidity and mortality with multiple aetiological causes including bacteria and virus. Often the causal agent is not known or recorded in routine medical practice hindering the estimation of cause-specific burden of disease from electronic medical records. No estimates are available for norovirus-associated hospitalizations in the paediatric population in the UK or for norovirus-associated deaths in children and adults aged under 65 years old. Moreover, the impact of gastroenteritis on chronic conditions, such as diabetes, is not well understood. This study aims to estimate the burden of medically attended gastroenteritis, in primary and secondary care settings, overall and in the diabetic population. To account for limited recording of infectious agent, a statistical model will be developed to estimate the frequency of gastroenteritis episodes attributable to norovirus, based on the temporal patterns of occurrence of gastroenteritis, overall and cause-specific, and accounting for population age groups. The project constitutes a case-study in developing methods to better estimate cause-specific burden of infectious diseases based on electronic medical records, with incomplete data. Evidence of cause-specific burden of disease can greatly improve the design of preventive measures, e.g. vaccination programs, as well as monitoring their public health impact.
Source -
Examining the impact of national guidelines on antipsychotic drug prescribing to older people with dementia — Jill Stocks ...
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Examining the impact of national guidelines on antipsychotic drug prescribing to older people with dementia
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-04
Organisations:
Jill Stocks - Chief Investigator - University of Manchester
Darren Ashcroft - Collaborator - University of Manchester
Evangelos Kontopantelis - Collaborator - University of Manchester
Roger Webb - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
Prescribing antipsychotic drugs to older patients with dementia without an accompanying psychosis diagnosis should be avoided as far as possible. Consequently there has been a series of regulatory warnings, clinical guidelines and reports published between 2004 and 2012 that aimed to discourage such potentially inappropriate prescribing. We aim to examine the impact of these interventions on the potentially inappropriate prescribing of all antipsychotic drugs, and different classes and types, using an interrupted time series analysis. We will also use a two level logistic regression model to identify which factors are important in predicting what type of patient or practice is at increased risk of the potentially inappropriate prescribing. The practice level predictors will be list size, Index of Multiple Deprivation (IMD) quintile, location of practice by region and the proportion of older patients registered at the practice. Patient level predictors will be age, gender and polypharmacy. The heterogeneity between practices will be quantified by the 95% prediction intervals derived from the model. A secondary aim will be to compare the duration of prescribing for patients receiving their first antipsychotic prescription in the early and later years of the study period using a Kaplan Meier time to event analysis.
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Long-term outcomes of NHS Health Checks in England. — Martin Gulliford ...
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Long-term outcomes of NHS Health Checks in England.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-25
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Samah Alageel - Corresponding Applicant - King's College London (KCL)Outcomes:
Primary outcomes: Data will be analysed for changes in all-cause mortality and CHD and stroke clinical events, diabetes diagnosis and chronic kidney disease (CKD) diagnosis. Where feasible stroke will be classified as haemorrhagic or ischaemic. CHD events will be classified as angina, myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention and other. To ascertain cases of diabetes, diabetes drug prescriptions will be analysed by mapping drug codes to chapter subheadings in the British National Formulary. Medical diagnosis codes and levels of HbA1c levels (6.5%) will be analysed as well as diabetes diagnosis records. Medical diagnosis codes and levels of serum creatinine will be used to ascertain CKD cases. Secondary outcomes: CVD risk and CVD risk factors, including: smoking, BP, total cholesterol, HDL and BMI. Data on medication prescription for antihypertensive drugs, lipid-lowering drugs, antiplatelet drugs and nicotine replacement therapy will be analysed by recording drug codes to chapter subheadings in the British National Formulary.
Description: Technical Summary
A new programme of NHS Health Checks (NHSHC) was introduced in the UK in 2009. This aims to provide cardiovascular risk assessment every five years for adults aged 40-74 who are not already diagnosed with CVD or diabetes. The NHSHC offers a promising strategy for preventing CVD, yet several concerns have been raised in relation to its uptake, cost-effectiveness, success in reducing diseases and effectiveness of risk management. In this context, evaluation of the programme's longer-term outcomes is crucial. This study aims at evaluating changes in risk and cardiovascular clinical events and mortality outcomes following uptake of a health check. We will use a matched cohort design in the CPRD by comparing participants with a record of a complete NHSHC between 1st of April 2010 and 31st of March 2013 with follow-up data available for a minimum of three years after their health check up to 31st March 2016, together with matched control participants who did not receive a health check. We will adopt a time-to-event framework with date of check as the start date to evaluate the onset of new prescriptions. Hazard ratios will be estimated using the cox proportional hazards model and incident rate ratios using Poisson regression to examine the association between the programme and changes in clinical events and mortality.
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AED treatment sequencing and effectiveness in epilepsy patients, in real life clinical practice in England — Simon Borghs ...
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AED treatment sequencing and effectiveness in epilepsy patients, in real life clinical practice in England
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-22
Organisations:
Simon Borghs - Chief Investigator - UCB Pharma SA - UK
Simon Borghs - Corresponding Applicant - UCB Pharma SA - UK
Graham Powell - Collaborator - University of Liverpool
John Logan - Collaborator - UCB Pharma SA - UK
Victor A. Kiri - Collaborator - Parexel International (UK) LtdOutcomes:
The following possible outcomes will be defined. The outcomes are mutually exclusive. 1. One-year, 2-year, 5-year remission from seizures (mutually exclusive) 2. Possible misdiagnosis 3. Unclear outcome and untreated at end of follow-up 4. Unclear outcome and treated at end of follow-up
Description: Technical Summary
This will be a descriptive, exploratory cohort study. Broadly, the objective of this study is to assess the evolution of (1) Anti-epileptic drug (AED) prescription patterns and sequencing, and (2) treatment outcomes in real-life clinical practice in England. Patients will be selected with a definite diagnosis of epilepsy between April 1st 2003 and the latest available data, where diagnosis is defined as a diagnosis of epilepsy made by a neurologist in the in- or outpatient setting, as recorded in HES or primary care data. Patients will be categorised as having been diagnosed in one of 3 time periods (eras). Treatment patterns between eras will be explored, as the percentage of patients prescribed a certain AED. For every patient, treatment outcome will be assessed, as remission (absence of seizure codes and new AED attempts), possible misdiagnosis (presence of a differential diagnosis code, cessation of all AED treatment, and absence of further seizure codes), or unclear outcome. Outcome will be analysed using Kaplan-Meier methods, with or without the use of cumulative distribution methods, in cases of competing risks.
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A longitudinal safety study of patients with psoriasis and psoriatic arthritis treated with either Otezla (apremilast) or a comparator drug — Susan Jick ...
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A longitudinal safety study of patients with psoriasis and psoriatic arthritis treated with either Otezla (apremilast) or a comparator drug
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-16
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Malignancy - Including, separately: a) solid tumors, b) hematological tumors, and c) non melanoma skin cancers. Opportunistic and serious infections - Including pneumocystis pneumonia, cryptospodiosis, tuberculosis, diseases due to mycobacteria, bartonellosis, leukoencephalopathy, candidiasis, cryptococcis, other mycoses, cytomegaloviral disease, herpes simplex, herpes zoster, human papilloma virus, viral hepatitis, Epstein-Barr virus, histoplasmosis, and toxoplasmosis. Suicide behaviors - Including, separately: a) suicidal ideation, b) suicide attempt, and c) suicide. Depression - Patient will be required to have at least 1 prescription for an antidepressant drug in addition to a code for depression to qualify as a case. Major adverse cardiac events (MACE) - Including all incident myocardial infarctions, strokes, fatal myocardial infarctions and sudden deaths. If a patient has more than one of these outcomes the first to occur will be included. Vasculitis - Including renal and nodular vasculitis, polyarteritis nodosa, temporal arteritis, and all other vasculitis conditions. Tachyarrhythmia - Including atrial fibrillation and flutter, supraventricular tachyarrhythmia and tachycardia, and ventricular tachycardia, fibrillation, and flutter. Hypersensitivity - Including skin eruptions and rashes, oedemas, anaphylactic reactions, and nonspecific hypersensitivity. Anxiety/nervousness - A patient will be required to have at least 1 prescription in addition to a code for anxiety/ nervousness to qualify as a case. Mortality - Including all-cause mortality and cause specific mortality.
Description: Technical Summary
This will be a cohort study of patients with psoriasis or psoriatic arthritis. From the psoriasis population we will identify all users of the newly marketed drug Otezla (exposed) and a matched cohort of patients with psoriasis or psoriatic arthritis who did not receive Otezla (non-exposed). We will calculate rates of multiple study outcomes (Malignancy, including solid tumors, hematologic, tumors, and non-melanoma skin cancer, opportunistic and serious infections, suicide and suicidal ideation, depression, major adverse cardiovascular events, vasculitis, tachyarrhythmia, hypersensitivity, anxiety/nervousness, and mortality), in the exposed and unexposed cohorts and calculate relative risk estimates for each outcome, adjusted for important confounders. This study will be carried out in 3 phases: The first will be a review of all Otezla users and outcomes after the first year on the market in the UK. The second phase will be conducted among Otezla users and the comparison cohort three years after Otezla is marketed in the UK, and the third will be conducted 5 years post-marketing.
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An epidemiological study of Antiphospholipid Syndrome using electronic health records — Martin Gulliford ...
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An epidemiological study of Antiphospholipid Syndrome using electronic health records
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-17
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
David D'Croz - Collaborator - King's College London (KCL)Outcomes:
We will evaluate the clinical features of the CPRD APS cohort. This will be done by evaluating the frequency distribution of READ codes, and READ terms, in the clinical and referral records of study patients. Venous thrombosis, myocardial infarction, stroke, miscarriage and fetal death will be specifically evaluated. The presenting features and delay before diagnosis will be described. Comorbidities, including systemic autoimmune diseases in patients with secondary APS will be evaluated. Patterns of treatment including use of anticoagulants, antiplatelet drugs, steroids and immunosuppressive drugs will be described. The distribution of cases by deprivation quintile will be evaluated.
Description: Technical Summary
Antiphospholipid syndrome (APS) is a disorder of the immune system that causes an increased risk of arterial and venous thrombosis. People with APS are at risk of developing conditions such as deep vein thrombosis, pulmonary emboli, myocardial infarction and stroke. Pregnant women with APS also have an increased risk of recurrent miscarriage, intrauterine growth restriction and late pregnancy loss, although the exact reasons for this are uncertain. It is estimated that APS is responsible for one in every ten cases of deep vein thrombosis (DVT), one in seven strokes and one in nine heart attacks and one in every six cases of recurrent (three or more) miscarriages. However, these estimates are not based on sound epidemiological data. There have been few epidemiological studies of APS. Most reports to date have been of clinic-based case series. The only data on mortality are from a European registry study from tertiary referral centres. We aim to add to knowledge concerning the epidemiology of APS by implementing a descriptive epidemiological study in CPRD. We expect to analyse data for more than 2,000 cases from 1990 to 2015. We aim to describe the age at diagnosis, duration and type of symptoms before diagnosis, prognosis and mortality, and patterns of treatment. A validation study will be done to confirm APS diagnoses by sending a questionnaire to the GPs of affected patients. This information will increase understanding of the condition and contribute to earlier recognition and possibly better treatment.
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Examining changing patterns of antidepressant use in children, 2000 to 2015 — Darren Ashcroft ...
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Examining changing patterns of antidepressant use in children, 2000 to 2015
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-04
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Jane Sarginson - Corresponding Applicant - University of Manchester
Jill Stocks - Collaborator - University of Manchester
Roger Webb - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
This study will use CPRD-Gold data to examine changes in antidepressant prescribing patterns in 3 to 17 year olds between 2000 and 2014. It will examine the overall level of antidepressant prescribing and the yearly incidence rate for index prescriptions for each class of antidepressant. An index prescription will be defined as the first ever recording of an antidepressant prescription in CPRD. Changes in the proportion of index prescriptions temporally linked with Read codes for depression, and differences in prescribing trends between genders and age groups will also be examined. A closer examination of the characteristics of those being prescribed antidepressants for the first time will be carried out for years 2006 and 2013. This will include examining diagnosis codes recorded on the index prescription date and those recorded within an expanded time-window of 3 months prior to and 1 month after the index prescription date, to examine alternative uses of antidepressants.
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An investigation of the completeness and accuracy of the recording of stroke events (including by subtype) in primary (CPRD) and secondary care databases (HES and ONS) — Jennifer Quint ...
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An investigation of the completeness and accuracy of the recording of stroke events (including by subtype) in primary (CPRD) and secondary care databases (HES and ONS)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-31
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Ann Morgan - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Subarachnoid haemorrhage; intracerebral haemorrhage; cerebral infarction; stroke not specified as haemorrhage or infarction; transient cerebral ischaemic attacks (TIAs) and related syndromes.
Description: Technical Summary
The overall aim of this study is to assess the completeness and diagnostic validity of the recording of stroke, by subtype, in primary care using HES as a reference. To this end we will construct - using HES in-patient data - a retrospective cohort of patients who have been hospitalised and diagnosed as having had a stroke. For those patients with linked CPRD-HES records, we will compare various aspects of the recording of individual stroke events across the two data sources. We will conduct a similar exercise using ONS data.
We will assess the completeness of the recording of stroke events in CPRD in a Venn diagram. We will also investigate the level of event date agreement across data sources. If we find a significant proportion of unrecorded stroke events in CPRD, we will perform logistic regression analyses to establish whether factors such as age, sex, year of stroke and mortality are contributing to the suboptimal recording of stroke in primary care. In addition, we will assess the diagnostic accuracy of CPRD stroke recording by subtype (ischaemic, subarachnoid hemorrhagic, intracerebral haemorrhagic, TIAs) and determine the sensitivity and positive predictive value (PPV) of different stroke code sets (all stroke and for stroke subtypes).
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Descriptive Epidemiology of Multimorbidity in Primary Care: A Cross-Sectional Study — Duncan Edwards ...
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Descriptive Epidemiology of Multimorbidity in Primary Care: A Cross-Sectional Study
Datasets:GP data, The outcome of our descriptive analysis is the prevalence of multimorbidity, and we will define multimorbidity using a list of 36 comorbidities. In addition to describing the prevalence of multimorbidity, as part of our descriptive analysis we are interested in the pairing and clustering of different comorbidities. To assess the frequency of the most commonly paired comorbidities, our outcome will be pairs of any two separate morbidities from the code list of 36 comorbidities. Additionally, to evaluate our final descriptive outcome relating to the prevalence of physical-mental health comorbidities, mental health comorbidities will be defined as Depression and Anxiety, Alcohol Problems, Dementia, Learning Disability, and Schizophrenia or Bipolar Disorder. All other morbidities will be defined as physical.
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-05-02
Organisations:
Duncan Edwards - Chief Investigator - University of Cambridge
Steven Kiddle - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Amelia Harshfield - Collaborator - University of Cambridge
Kirsty Rhodes - Collaborator - University of Cambridge
Paul Kirk - Collaborator - University of Cambridge
Rupert Payne - Collaborator - University of Bristol
Simon Griffin - Collaborator - University of Cambridge
Sylvia Richardson - Collaborator - University of Cambridge
Yajing Zhu - Collaborator - University of CambridgeOutcomes:
The outcome of our descriptive analysis is the prevalence of multimorbidity, and we will define multimorbidity using a list of 36 comorbidities. In addition to describing the prevalence of multimorbidity, as part of our descriptive analysis we are interested in the pairing and clustering of different comorbidities. To assess the frequency of the most commonly paired comorbidities, our outcome will be pairs of any two separate morbidities from the code list of 36 comorbidities. Additionally, to evaluate our final descriptive outcome relating to the prevalence of physical-mental health comorbidities, mental health comorbidities will be defined as Depression and Anxiety, Alcohol Problems, Dementia, Learning Disability, and Schizophrenia or Bipolar Disorder. All other morbidities will be defined as physical.
Description: Technical Summary
Multimorbidity is becoming increasingly prevalent in England, and the effective management of multimorbid patients should be a priority of primary care medicine. In order to effectively plan health services to treat multimorbid patients, we must understand the epidemiology of this condition, and the current relationship between multimorbidity and health service usage. This research is primarily a descriptive epidemiological study looking at the burden of multimorbidity in primary care in England. It will consist of both a cross-sectional, descriptive study of the prevalence of multimorbidity, and a follow-on retrospective cohort analysis investigating the relationship between multimorbidity and health service utilisation. Using a random of sample of 425,400 patient records, we will describe the prevalence of multimorbidity, and will investigate differences in multimorbidity among various sociodemographic covariate groups. Additionally, we will investigate any linkages between mental and physical comorbidities, and patterns of the most common comorbidities. In the four-year retrospective cohort aspect of our study, we will use regression models to examine how health service utilisation may differ according to the presence of multimorbidity. Our primary outcomes will be the number of GP consultations, the number of prescriptions dispensed, and the number of hospitalisations.
Source
2016 - 04
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Urinary tract infections in the elderly - care pathways and characteristics — Paul Aylin ...
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Urinary tract infections in the elderly - care pathways and characteristics
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Paul Aylin - Chief Investigator - Imperial College London
Myriam Gharbi - Corresponding Applicant - Imperial College London
Alan Johnson - Collaborator - Public Health England
Alison Holmes - Collaborator - Imperial College London
Hannah Lishman - Collaborator - Imperial College London
Joseph Drysdale - Collaborator - St George's, University of London
Mariam Molokhia - Collaborator - King's College London (KCL)
Rosalind Goudie - Collaborator - Imperial College LondonOutcomes:
Type of care pathway for UTI. Risk factors for complicated UTI. Prevalence of presenting UTI signs and symptoms Mortality
Description: Technical Summary
The objective of this study is to gain a better understanding of the characteristics and management of urinary tract infections (UTIs) among elderly patients in primary care, particularly with respect to diagnosis, care pathways and antibiotics prescribing.
Patients with a diagnosis of lower or suspected UTI, with at least one year's practice registration prior to the episode of UTI, and sufficient follow-up data in the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) data will be selected. Data relating to comorbidities, general practitioner consultations and hospital admissions for these patients will be extracted from patient consultation histories and HES; and symptoms reported in any consultations in the month prior to the index UTI consultation will be collated.
For analysis purposes, patients will be grouped according to the complexity of their care pathway during that episode of UTI, namely: those managed solely within primary care: a) with a single consultation, b) with multiple consultations, and c) those hospitalised due to their UTI, or developing an advanced UTI, bacteraemia or sepsis.
Descriptive and analytical statistics will be used to describe the characteristics and symptoms of patients presenting with a UTI, their primary care pathways, prescribing patterns and outcomes.
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Association Between Blood Eosinophil Level and Exacerbation Risk in Patients with COPD — Jeanne Pimenta ...
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Association Between Blood Eosinophil Level and Exacerbation Risk in Patients with COPD
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-19
Organisations:
Jeanne Pimenta - Chief Investigator - BioMarin Pharmaceutical Inc.
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.
Shibing Yang - Collaborator - GSKOutcomes:
COPD exacerbations
Description: Technical Summary
The objective is to examine the association between blood eosinophils and subsequent risk for exacerbations in patients with COPD being treated with long-acting and/or short-acting bronchodilators, with or without inhaled corticosteroids (ICS).
The design is a retrospective cohort study of patients with COPD as evidenced by a medical code in the CPRD between January 2004 and February 2013. The index date is the date of the first blood eosinophil measurement (study exposure) between January 2010 and February 2013 that follows the COPD medical code and meets the stable state and other inclusion requirements. The 12-month period before the index date will be used to assess demographics, exacerbation and treatment history. The follow up period from index date until censoring date, the earliest of the following events: 1. death, 2. leaving the practice, or 3.end of follow-up on February 28, 2014, will be examined for the occurrence of COPD exacerbations (study outcome).
Descriptive analysis will be conducted. A negative binomial model will be used to examine the association between blood eosinophils and exacerbation rate. Stratified analyses based on 1) time-varying ICS use during follow-up and 2) exacerbation history in the 12 months preceding the index date will also be conducted.
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The association between severe mental illness and chronic kidney disease: a cross sectional study — Laurie Tomlinson ...
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The association between severe mental illness and chronic kidney disease: a cross sectional study
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Corresponding Applicant - University of Tsukuba
David Osborn - Collaborator - University College London ( UCL )
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Joseph Hayes - Collaborator - University College London ( UCL )
Kate Walters - Collaborator - UCL Hospital
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
Prevalence of CKD (including renal replacement therapy) among patients with SMI, compared with patients without SMI Prevalence of CKD risk factors among patients with and without SMI
Description: Technical Summary
Our objectives are to: (i) compare the prevalence of chronic kidney disease (CKD) between patients with and without severe mental illnesses (SMI); (ii) describe the prevalence of known CKD risk factors between the groups; and (iii) compare the recognition and management of CKD by GPs between the groups. We will conduct a cross-sectional study, where the study population is all people aged 25-74 registered for more than one year in CPRD (up-to-standard) at 31st March 2014. SMI are defined using a previously validated list of Read codes. CKD will be defined as the most recent estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, which is calculated from serum creatinine value recorded in CPRD. Patients on renal replacement therapy (RRT) will be defined using a Read code list. For objective (i), proportion of people with eGFR<60 mL/min/1.73m2, eGFR<30 mL/min/1.73m2, and RRT will be compared between patients with and without SMI, by age (every 10 years) and sex. For objective (ii), the prevalence of known CKD risk factors will be described for each group. For objective (iii), we will compare the proportion of patients with recorded diagnosis of CKD, the most recent blood pressure, and use of angiotensin converting enzyme inhibitor or angiotensin receptor blockers, between patients with and without SMI.
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Historical cohort study to evaluate undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease — David Price ...
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Historical cohort study to evaluate undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-18
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jessica Martin - Corresponding Applicant - Wellcome Trust Sanger Institute
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Elizabeth Gardener - Collaborator - Cambridge Research Support Ltd.
Emil Loefroth - Collaborator - NOVARTIS
Jean-Bernard Gruenberger - Collaborator - NOVARTIS
Joan Soriano - Collaborator - Research in Real Life ltd.( RiRl )
John Hurst - Collaborator - UCL Hospital
Konstantinos Kostikas - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Pierguiseppe Agostoni - Collaborator - University of Milan
Robert Fogel - Collaborator - NOVARTIS
Rupert Jones - Collaborator - Plymouth UniversityOutcomes:
Diagnosis of, and treatments for COPD COPD exacerbations Diagnosis of, and treatments for, heart failure (HF) Other cardiac and vascular events Mortality (COPD, HF and all-cause)
Description: Technical Summary
The objectives of this study are to assess the prevalence of comorbid diagnosed COPD and HF and to describe therapies prescribed and diagnostic tests undertaken by clinicians in real-life clinical practice for patients with COPD and/or HF. Additionally, it will evaluate the long-term respiratory and cardiovascular outcomes associated with the prescribed therapies for patients with comorbid COPD and HF. This study will be conducted using historical data from patients with COPD and/or heart failure. The prevalence of comorbid diagnosed COPD and HF will be assessed at the time of most recent data available for each patient, from all patients with a diagnosis of either COPD and/or HF. COPD and HF therapies prescribed and diagnostic tests undertaken will be considered in the year prior to most recent data available, between January 2010 to date for patients, comparing patients with comorbid COPD and HF to those with COPD alone and to those with HF alone. Cardiovascular and respiratory outcomes will be assessed for patients with comorbid COPD and HF, comparing those with adequate versus inadequate treatment for COPD/HF (according to guidelines). These outcomes will be assessed over at least one year and up to three years.
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Assessing drivers of effectiveness and safety using real life data: anticoagulants as a case study — Olaf Klungel ...
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Assessing drivers of effectiveness and safety using real life data: anticoagulants as a case study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Hendrika van den Ham - Corresponding Applicant - Utrecht University
Andrea Burden - Collaborator - ETH Zurich
Cynthia Girman - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Frank de Vries - Collaborator - Utrecht University
Hubert Leufkens - Collaborator - Utrecht University
Johan Erpur Adalsteinsson - Collaborator - Novo Nordisk
Mikkel Zollner Ankarfeldt - Collaborator - Novo Nordisk UK
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tjeerd van Staa - Collaborator - University of Manchester
Vinay Mehta - Collaborator - GSKOutcomes: none known
Description: Technical Summary
Objective
With this study we aim to characterize new users of NOACs and new users of warfarin and to compare effect size of these drugs in relation to time since launch of the NAOCs in the Clinical Practice Research Datalink (CPRD). Furthermore, we would like to assess different analytical approaches to estimate the comparative effectiveness/safety over time. Results will be compared to a similar study carried out in the US MarketScan data.Methods
A retrospective cohort study will be conducted within the UK CPRD from 2010-2013. Patients with a diagnosis of AF and with at least one first prescription of either warfarin or one of the NOACs will be extracted. They will be followed from the date of first prescription until the occurrence of stroke, a major bleeding, systemic embolism or all-cause mortality event.Data analysis
Covariate plots and propensity plots will be used to show how patient characteristics change over time. Comparative effectiveness/safety of warfarin and NOACs will be evaluated at different time points using a propensity score matched model. Additional we will estimate effect sizes again with conventional logistic regression and disease risk score methods.
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Hematological malignancies in patients with systemic lupus erythematosus versus matched controls: a population-based study in the United Kingdom. — Frank de Vries ...
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Hematological malignancies in patients with systemic lupus erythematosus versus matched controls: a population-based study in the United Kingdom.
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-10
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Arief Lalmohamed - Collaborator - University Medical Centre Utrecht
Irene E M Bultink - Collaborator - Amsterdam Rheumatology and immunology Center
Marielle Wondergem - Collaborator - Amsterdam Rheumatology and immunology CenterOutcomes:
Incidence of hematological cancer
Description: Technical Summary
SLE is a chronic systemic autoimmune disease, which predominantly affects young and middle-aged individuals and is associated with an increased mortality risk. Malignancy is one of the most frequent causes of death among SLE patients, accounting for up to 20% of deaths in cohort studies, but studies on overall cancer risk in SLE have shown conflicting results. Increased risks for hematological malignancies and a significant increase in the risk of death due to specific malignancies, particularly non-Hodgkinâs lymphoma in SLE patients compared to the general population have been reported. However, the influence of sex, age, disease duration, and exposure to frequently used drugs (i.e. cyclophosphamide, azathioprine, systemic glucocorticoids, and antimalarials) on cancer risk in SLE is unclear. The objective of this retrospective study is, in a population-based cohort, to estimate overall and sex-specific hematological cancer risks in a large number of patients with SLE and relative risks compared with matched controls. In addition, the influence of age, disease duration, co-existing Sjögrenâs syndrome and exposure to systemic glucocorticoids, immunosuppressives and hydroxychloroquine on hematological cancer risk in SLE will be investigated.
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Determinants of exacerbations of asthma — Jennifer Quint ...
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Determinants of exacerbations of asthma
Datasets:GP data, HES Accident and Emergency; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Chloe Bloom - Collaborator - Imperial College London
Francis Nissen - Collaborator - Roche
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Pavord - Collaborator - University of Oxford
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Paul Cullinan - Collaborator - Imperial College LondonOutcomes:
Exacerbations as defined in CPRD, HES or ONS. All exacerbations will be used as a composite outcome and then severe exacerbations (those resulting in hospitalisation and death only) will be investigated separately. Exacerbations will be defined by LRTI codes, OCS prescription 5-14 days, OCS and antibiotics, hospital admission, A&E attendance, death, GP consultation out of hours based on previous work.
Description: Technical Summary
In the UK, over 5.4 million people have asthma, and the condition accounts for over 65,000 hospital admissions and 1,000 deaths annually. People with asthma may experience periods of acute worsening of symptoms: cough, wheeze, breathlessness and sputum production. Asthma exacerbations range from mild attacks, which interrupt daily life and work productivity, to severe and life-threatening attacks. In other long term respiratory conditions such as COPD, people who have exacerbations are at risk of having further exacerbations. Whether or not this is true in asthma and whether there are specific factors that affect the likelihood of having an exacerbation of asthma has not been investigated. Using linked CPRD, HES, and ONS data, we will use conditional logistic regression to undertake a nested case control study in a cohort of asthma patients to determine what factors are associated with having an exacerbation.
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A prevalence and incidence study of multimorbidity in the UK using the Clinical Practice Research Datalink (CPRD) — Kazem Rahimi ...
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A prevalence and incidence study of multimorbidity in the UK using the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Kazem Rahimi - Chief Investigator - The George Institute for Global Health
Jenny Tran - Corresponding Applicant - The George Institute for Global Health
Amit Kiran - Collaborator - University of OxfordOutcomes:
Each variable will defined by a combination of Read codes (CPRD), ICD-10 codes (HES and ONS) and BNF medication codes (CPRD, HES). Where available, phenotypes defined and previously used by The George Institute will be updated for this study. If this is also not available, a code phenotype will be developed using Read codes, ICD-10 codes and BNF medication codes.
Description: Technical Summary
This study examines the burden of chronic conditions, comorbidity and multimorbidity in the UK. Incidence and prevalence rates will be calculated for individual chronic conditions that have previously been well-studied in multimorbidity research. Chronic conditions will be defined by a list derived from: the UK Quality and Outcomes Framework 2015, the Charlson Comorbidity Index and the US Department of Health and Human Services Multiple Chronic Conditions framework. Comorbidity will be defined with reference to 6 clinically important index conditions: ischaemic heart disease, stroke, heart failure, diabetes, chronic kidney disease and chronic obstructive pulmonary disease. Multimorbidity will be defined as having two or more chronic conditions. We will also examine the nature of multimorbidity by subgroups defined by Charlson Comorbidity Index score, and combinations of up to 5 of the most prevalent chronic conditions. Prevalence (by calendar year) and incidence will be calculated for each of these defined subgroups of comorbidity and multimorbidity. We will also examine determinants of multimorbidity by stratification into age groups, sex, socioeconomic status and calendar year; and regression models adjusting for hypertension, cholesterol, smoking, body mass index, anti-hypertensive treatment and lipid-lowering therapy. We will also examine temporal trends in multimorbidity combinations through phenomapping, which is unbiased phenotype mapping using unsupervised machine learning.
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A Retrospective Descriptive Study of the Cohort of Type 2 Diabetes Mellitus Patients Initiating a Second-line Therapy in the United Kingdom Clinical Practice Research Datalink (CPRD) Database — Jesus Medina ...
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A Retrospective Descriptive Study of the Cohort of Type 2 Diabetes Mellitus Patients Initiating a Second-line Therapy in the United Kingdom Clinical Practice Research Datalink (CPRD) Database
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Jesus Medina - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Jesus Medina - Corresponding Applicant - Astra Zeneca Ltd - UK Headquarters
Betina Blak - Collaborator - Astra Zeneca Ltd - UK Headquarters
Nze Shoetan - Collaborator - Astra Zeneca Inc - USA
Robert LoCasale - Collaborator - Astra Zeneca Inc - USAOutcomes:
Length of follow-up (i.e., from cohort entry date until the former of end of exposure, transfer out of practice, last data collection from practice, or end of study window). - Background characteristics at the time of initiation of 2nd line therapy (most recent status prior to or on cohort entry date) - Clinical Variables at the time of initiation of 2nd line therapy (most recent status prior to or on cohort entry date) and (separately) afterwards, until 31-October-2015. - Blood biochemistry at the time of initiation of 2nd line therapy (most recent status prior to or on cohort entry date) and (separately) afterwards, until 31-October-2015. - Routine and random urine samples at the time of initiation of 2nd line therapy (most recent status prior to or on cohort entry date) and (separately) afterwards, until 31-October-2015. - Antidiabetic medications at the time of initiation of 2nd line therapy (most recent status prior to or on cohort entry date) and (separately) afterwards, until 31-October-2015. - Antihypertensive medications (Angiotensin Converting Enzyme inhibitors / Angiotensin Receptor Blockers [ACEi/ARB]) at the time of initiation of 2nd line antidiabetic therapy (most recent status prior to or on cohort entry date) and (separately) afterwards, until 31-October-2015.
Description: Technical Summary
DECIDE is an AstraZeneca-sponsored pragmatic trial currently being conducted by CPRD investigators, comparing the effectiveness of dapagliflozin and standard of care in patients with T2DM. The proposed CPRD study, a purely descriptive observational, prospective study of a large historical cohort of patients with T2DM initiating a 2nd line antidiabetic treatment between 1-August-2013 and 30-April-2015, will help to put into context and better understand future results of the DECIDE study. Its primary aim is to describe patient disease characteristics, prospective disease management patterns and disease control. Data completeness / availability of some of the key DECIDE variables (HbA1c, weight, severe hypoglycaemic events, antidiabetic medications) over time will also be evaluated. The study will collect data on patient characteristics (demographics, diabetes diagnosis, medical history), 1st and 2nd line antidiabetic treatment and changes over time, HbA1c levels, comedications, comorbidities and disease control over time. Statistical methods will include descriptive analyses of data using frequency and percentage distributions for categorical variables and means (± standard deviation), median (quartiles) and 95% CI for continuous variables. Since there will be no analyses of potential associations between treatments and outcomes, and the inclusion/exclusion criteria are very broad, the risk of bias or confounding is minimal.
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The epidemiology and treatment patterns of patients with Gastro-oesophageal reflux disease (GORD) in routine general practice. — Craig Currie ...
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The epidemiology and treatment patterns of patients with Gastro-oesophageal reflux disease (GORD) in routine general practice.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-19
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Dafydd Williams - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Ellen Hubbuck - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes:
Patient and clinical characteristics at first GORD diagnosis Rates of hospital admission for GORD Baseline characteristics and treatment pathways in patients with GORD by first therapy type Switching patterns and time to switching between alginate product groups
Description: Technical Summary
We aim to describe the epidemiology of patients diagnosed with gastro-oesophageal reflux disease (GORD), selecting patients who have a first diagnosis of GORD in 2009, have been registered for at least five years at an up-to-standard practice at the date of diagnosis, and are eligible for HES linkage. We will look at incident exposures of these patients and examine the distribution of age and sex. The rate of hospital admissions per 1000 patient years will also be calculated.
Patterns of treatment with proton pump inhibitors (PPIs) and prescribed alginates in patients diagnosed with GORD will also be described. Treatment paths will be observed for patients from their first prescription for an alginate or a PPI, or for a combination of PPI plus alginate, where these share a first prescription date. In addition, analyses will be performed on the switching patterns between two alginate product groups: commonly used, branded alginates and other alginate-containing products. Time to first switch will be compared between alginate groups using a Cox proportional hazards model.
Source - and 6 more projects — click to show
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Vaccine effectiveness of the national rotavirus vaccination programme against acute gastroenteritis in England — Sara Thomas ...
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Vaccine effectiveness of the national rotavirus vaccination programme against acute gastroenteritis in England
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-10
Organisations:
Sara Thomas - Chief Investigator - Not from an Organisation
Sara Thomas - Corresponding Applicant - Not from an Organisation
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Julia Stowe - Collaborator - Public Health England
Justin Fenty - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health England
Shamez Ladhani - Collaborator - Public Health EnglandOutcomes:
Incidence of acute infectious gastroenteritis Incidence of acute gastroenteritis of unspecified cause
Description: Technical Summary
Rotavirus is the commonest cause of severe diarrhoea in young infants. The monovalent oral live-attenuated vaccine Rotarix was introduced into the infant vaccination schedule in England in July 2013. The vaccine was shown in pre-licensure trials to have high vaccine efficacy against severe rotavirus diarrhoea, but it is important to assess the vaccine's effectiveness in public health use.
In this study we will use general practice data linked to other datasets to investigate the effectiveness of rotavirus vaccination against incident acute gastroenteritis, and against severe gastroenteritis requiring hospitalisation. Our study population will be infants born in England after April 2013 who were eligible for rotavirus vaccination. Using a cohort study design and multivariable random-effects Poisson regression, rates of acute gastroenteritis, and of hospitalisation following gastroenteritis, will be compared in infants who were vaccinated and unvaccinated. This will enable vaccine effectiveness to be estimated.
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Developing and validating a risk prediction model based on frailty syndrome using primary care data — Michael Soljak ...
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Developing and validating a risk prediction model based on frailty syndrome using primary care data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-19
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Michael Soljak - Corresponding Applicant - Imperial College London
Alan Poots - Collaborator - Imperial College London
Derek Bell - Collaborator - Imperial College London
John Soong - Collaborator - Medway Primary Care Trust
Lotte Dinesen - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Raffaele Palladino - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
This study aims are to develop and validate a risk prediction model based on frailty syndromes using primary care data, which will allow the burden of frailty at a population level to be defined and help predict and identify the severity of frailty. A previously published frailty model developed from NHS HES data; The Frailty Model in Acute Care (FMAC) will be used to assess its applicability in a national (England) primary care data set (CPRD data). The background to the model is that geriatric syndromes are recognized indicators of frailty. The Frailty model explored 3 key outcomes: In hospital mortality, 30 day readmission to hospital and functional dependence.
The study will use an open cohort of randomly selected patients aged 55-99 years between 2008 and 2010 registered with a CPRD GP practice for at least one year. Within the cohort those individuals having 'frailty syndrome', will be defined by using the identified frailty deficits and Read Codes. Mixed-effect logistic regression will be used for binary outcomes, linear mixed model for linear outcomes and mixed-effect Poisson for count outcomes. Cox Proportional Hazard model will be used to perform survival analyses.
For cross-validation of the frailty index we will use both receiver operating characteristics (ROC) curves and, for survival analysis, Harrel's C statistics.
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An epidemiological study of diabetes and diabetes-related morbidities in the UK children and young adults — Martin Gulliford ...
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An epidemiological study of diabetes and diabetes-related morbidities in the UK children and young adults
Datasets:GP data, Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-11
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Ali Abbasi - Collaborator - King's College London (KCL)Outcomes:
Diabetes-related health outcomes Health care utilisation
Description: Technical Summary
The prevalence of diabetes, and its main antecedent obesity, have been increasing both in adults and adolescents, but temporal trends in the incidence of diabetes, the distribution of different types of diabetes, and diabetes-related health conditions in children and young adults have not been studied in detail. We aim to investigate incidence and prevalence of different types of diabetes and the risk of co-morbidities among UK children and young adults. We will perform analyses of longitudinal primary care data from individuals in the CPRD aged 0 to 25 years from 1990 through 2015. We will conduct a matched cohort study of individuals with or without diabetes to investigate associations between diabetes and 8 classes of health outcomes. We will fit Poisson regression models to assess incidence of all diabetes types and diabetes-related conditions including cardiovascular, psychological/behavioural, microvascular, metabolic, pulmonary, gastrointestinal, and dental health outcomes, and cancers adjusting for potential confounders.
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Prescribing patterns of dependence forming medicines: Benzodiazepines, z-drugs, opioids and GABAergic drugs — Neil Smith ...
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Prescribing patterns of dependence forming medicines: Benzodiazepines, z-drugs, opioids and GABAergic drugs
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-20
Organisations:
Neil Smith - Chief Investigator - National Centre for Social Research
Neil Smith - Corresponding Applicant - National Centre for Social Research
Anysia Nguyen - Collaborator - National Centre for Social Research
Martin White - Collaborator - University of Cambridge
Matt Hickman - Collaborator - University of Bristol
Rukmen Sehmi - Collaborator - National Centre for Social Research
Sally McManus - Collaborator - National Centre for Social Research
Sam Rodgers - Collaborator - Plaza health centreOutcomes:
1. Assess the extent to which psychotropic drugs are prescribed among the Primary Care population, and outline the main features of prescriptions and individuals concerned 2. Explore whether long-term prescribing (i.e. use of drugs for durations which exceed recommended guidelines) is a real concern. 3. Understand the circumstances and demographic characteristics of individuals who are long-term prescribed psychotropic drugs compared to those who have been prescribed but not on a long-term basis.
Description: Technical Summary
Long-term prescribing of psychotropic drugs and their potentially associated risk of dependence is a health policy issue of concern. However, data availability has been very limited. The Clinical Practice Research Datalink provides with an important opportunity for researchers, as health history for individuals is provided by General Practitioners (GPs), including demographic characteristics of patients, treatments they have received and prescriptions received. In this context, this project attempts to assess the extent to which psychotropic drugs (Benzodiazepines, z-drugs, opioids and GABAergic drugs) are prescribed over time, to explore whether long-term prescribing is a real concern (doses and length of prescriptions above those recommended by The National Institute for Health and Care Excellence, NICE, guidelines); and to understand the circumstances (causes for treatment or illnesses) and demographic characteristics of individuals who are prescribed psychotropic drugs during the years 2000 and 2015. This analysis will be descriptive and tabular (providing basic statistics per year) and it will also consider simple hypothesis testing to compare socio-demographic characteristics of long-term prescribed patients.
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Premature mortality and non-fatal self-harm in patients diagnosed with Chronic Fatigue Syndrome — Darren Ashcroft ...
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Premature mortality and non-fatal self-harm in patients diagnosed with Chronic Fatigue Syndrome
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-28
Organisations:
Darren Ashcroft - Chief Investigator - University of Manchester
Matthew Carr - Corresponding Applicant - University of Manchester
Navneet Kapur - Collaborator - University of Manchester
Peter White - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Roger Webb - Collaborator - University of ManchesterOutcomes:
All-cause mortality Cause-specific mortality, including suicide Non-fatal self-harm
Description: Technical Summary
Our principal aim is to investigate whether patients with chronic fatigue syndrome (CFS) / myalgic encephalopathy (ME) are at an increased risk of all-cause mortality, unnatural death (including suicide), and non-fatal self-harm. We also aim to assess whether confounding effects can explain any elevations in risk observed. A matched cohort study will be used. Adult patients with a Read coded diagnosis of CFS between 01/01/2000 and 31/12/2014 and enrolled in a CPRD-contributing practice with relevant linkage, will be matched (on age, gender, and practice) with 20 unaffected comparison patients. Selection will be restricted to patients registered with a contributing practice for at least one year and follow-up will end when the patient either dies, transfers out of the practice, last data collection, or the study period ends on 31/12/2014. Causes of death will be defined according to ICD-10 classifications. Cox regressions will be used to investigate whether patients with CFS have elevated all-cause and cause-specific mortality risks. Hazard ratios (HRs) will be generated with and without adjustments for potential confounders. Adjustments will be made for area-level deprivation, body mass index (BMI), and smoking status. We will then apply the same process and investigate whether our findings also apply to patients diagnosed with other forms of fatigue syndrome including post-viral fatigue syndrome (PVFS) or an asthenia.
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Characterization of patients with COPD by mepolizumab eligibility criteria — Hana Mullerova ...
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Characterization of patients with COPD by mepolizumab eligibility criteria
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-04-19
Organisations:
Hana Mullerova - Chief Investigator - Astra Zeneca Ltd - UK Headquarters
Joe Maskell - Collaborator - Amgen Ltd
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.Outcomes:
Patient population types based on acute exacerbations of COPD history
Description: Technical Summary
The objective of this study is to enumerate and describe the patient population types that comprise the population of COPD patients that may be eligible for mepolizumab, and to describe the overlap of these patient population types. A cohort of COPD patients with a validated COPD medical code and an FEV1/FVC<0.7 in the CPRD between January 1, 2004 and December 31, 2015 will first be identified. Within that COPD cohort, patients who have a peripheral blood eosinophil measurement between January 1, 2010 and December 31, 2015 that occurs on or after entry into the COPD cohort will be eligible for inclusion if they have a HES link, at least 12 months of history preceding the eosinophil measurement index date, and meet all other inclusion and exclusion criteria. The 12 months preceding the index date will be examined for AECOPD exacerbation history, exposure to inhaled triple maintenance therapy for COPD, and other clinical characteristics. Descriptive statistics will be required for this analysis. The number and percentage of patients within each category will be described as well as the demographic and clinical characteristics of the patients within each category. The overlap between the patient population types will also be described.
Source
2016 - 03
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Benign and Malignant Tumors in Patients with Myotonic Dystrophy Type I — Shahinaz Gadalla ...
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Benign and Malignant Tumors in Patients with Myotonic Dystrophy Type I
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-14
Organisations:
Shahinaz Gadalla - Chief Investigator - National Cancer Institute ( NCI )
Shahinaz Gadalla - Corresponding Applicant - National Cancer Institute ( NCI )
Ana Best - Collaborator - National Cancer Institute ( NCI )
David Wolfson - Collaborator - McGill University
Hanns Lochmuller - Collaborator - Newcastle University
Julia Gage - Collaborator - National Cancer Institute ( NCI )
Lesley Anderson - Collaborator - Queen's University Belfast
Mark H Greene - Collaborator - National Cancer Institute ( NCI )
Rotana Alsaggaf - Collaborator - National Cancer Institute ( NCI )
Ruth Pfeiffer - Collaborator - National Cancer Institute ( NCI )
Wilhelmine Meeraus - Collaborator - GlaxoSmithKline - UK
Youjin Wang - Collaborator - National Cancer Institute ( NCI )Outcomes: none known
Description: Technical Summary
Myotonic dystrophy (or dystrophia myotonica; DM) is an autosomal dominant multi-system disorder. A previous study of 1,658 DM patients identified from the Swedish and Danish patient registries and linked to the corresponding cancer registries provided the first epidemiological evidence of an elevated cancer risk in DM patients. In this project, we propose to evaluate the risk of both benign and malignant tumors in patients with DM type 1 (DM1, also called Steinert's disease), identify potential clinical factors and risk modifiers for this observation. Accordingly, we plan to compare the risk of developing benign and malignant tumors in a cohort of DM patients identified from CPRD Gold and the integrated hospital episode statistics (HES) database with tumor risk in a matched control cohort of DM1-free individuals. Our analyses will quantify overall and site-specific tumor risks among DM1 patients and will identify risk factors contributing to such events. Analyses will be adjusted for common cancer risk factors (smoking history, BMI, and alcohol use) and for specific risk factors in anatomic site-specific analyses, such as parity in female reproductive cancers.
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The characteristics of rheumatoid arthritis patient organisation members and online community members with rheumatoid arthritis compared to the general rheumatoid arthritis population — William Dixon ...
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The characteristics of rheumatoid arthritis patient organisation members and online community members with rheumatoid arthritis compared to the general rheumatoid arthritis population
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-11
Organisations:
William Dixon - Chief Investigator - University of Manchester
Ruth Costello - Corresponding Applicant - University of Manchester
Benjamin Brown - Collaborator - University of Manchester
John McBeth - Collaborator - University of ManchesterOutcomes:
Rheumatoid arthritis diagnosis
Description: Technical Summary
The objective of this study is to determine the representativeness of people with rheumatoid arthritis (RA) who are National Rheumatoid Arthritis Society (NRAS) members and HealthUnlocked (HU) community members and visitors. The study population will come from two sources: NRAS members as of 1st January 2015, a survey of HU NRAS community members and visitors to the site, and previous studies that have used NRAS as a source of participants. The comparison group will be people with RA (as of 1st January 2015) identified from the Clinical Practice Research Datalink. For each dataset the number of participants and their characteristics where available (age, gender, region of the UK, types of medication, time since diagnosis, ethnicity, socioeconomic status and employment status) will be tabulated and compared using appropriate statistical tests.
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Treatment of uncomplicated mild hypertension in Primary Care — Richard McManus ...
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Treatment of uncomplicated mild hypertension in Primary Care
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-14
Organisations:
Richard McManus - Chief Investigator - University of Oxford
James Sheppard - Corresponding Applicant - University of Oxford
Jonathan Mant - Collaborator - University of Cambridge
Richard Hobbs - Collaborator - University of Oxford
Richard Stevens - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes: none known
Description: Technical Summary
Evidence to guide the pharmacological treatment of patients with uncomplicated (low cardiovascular disease risk), mild hypertension (blood pressure 140/90-159/99mmHg) is lacking. A definitive trial is unlikely due to the costs and numbers of patients required because of low event rates in this population. Yet many guidelines encourage treatment, and many patients are thought to receive it, despite little evidence of benefit.
This study will examine the extent to which patients are prescribed treatment for uncomplicated, mild hypertension in routine practice and the safety and efficacy of this treatment for using data from a large database of Primary Care records. The primary outcome of the study will be the rate of all-cause mortality in patients with uncomplicated mild hypertension prescribed antihypertensive treatment vs. those not prescribed therapy, matched using propensity scores estimating the likelihood of receiving treatment. Secondary outcomes will include the rate of cardiovascular morbidity/mortality, side effects to medication and rate of cancer in treated vs. non treated patients. These outcomes will be assessed using Cox proportional hazards modelling. The proportion of patients given lifestyle advice and/or pharmacological treatment for uncomplicated mild hypertension will also be estimated by year, and predictors of lifestyle advice/pharmacological treatment will be examined using logistic regression.
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Post-marketing study of ropinirole prolonged release tablets in Parkinson's disease: Evaluation outcomes associated with long term use of Ropinirole-PR using the UK clinical practice research datalink (UK-CPRD) — Usha Gungabissoon ...
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Post-marketing study of ropinirole prolonged release tablets in Parkinson's disease: Evaluation outcomes associated with long term use of Ropinirole-PR using the UK clinical practice research datalink (UK-CPRD)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-30
Organisations:
Usha Gungabissoon - Chief Investigator - GSK
Usha Gungabissoon - Corresponding Applicant - GSK
John Logie - Collaborator - GlaxoSmithKline - UK
Monika. Stender - Collaborator - GlaxoSmithKline - UK
Nicholas Galwey - Collaborator - GSKOutcomes:
All investigators are employed by and hold stocks and shares in GSK
Description: Technical Summary
This retrospective observational study will use a propensity score matched cohort design to estimate the incidence of dyskinesias, on-off phenomena and impulse control disorders amongst PD patients initiating ropinirole-PR monotherapy (ropinirole-PR cohort) compared to those initiating immediate release dopamine agonist monotherapy(IR-DA cohort). PD patients with at least one script of a dopamine agonist of interest (ropinirole-PR or an immediate release DA) prescribed between 2004-2012 and a minimum of 12 months registration prior to index date (date of treatment initiation) will be included. The incidence dyskinesia and other outcomes of interest events after the index date will be estimated in the ropinirole-PR cohort compared to the matched IR-DA cohort. Adjusted incidence rate ratios will be calculated using multivariable Poisson regression. A Cox proportional hazards regression model will evaluate time to dyskinesias in individuals prescribed ropinirole-PR with those prescribed immediate release dopamine agonists of interest with adjustments for time varying covariates. In addition, time to levodopa initiation in both cohorts will be estimated. Whilst some outcome data are available on the CPRD, it is necessary to supplement this with information to be obtained by GP questionnaire. Patients will be followed up to a maximum of 5 years of treatment. As part of these activities, treatment persistence and adherence will be evaluated as well as off-label use of ropinirole-PR.
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Evaluating the impact of NICE guidelines for suspected cancers in respect of diagnostic interval and other outcomes — William Hamilton ...
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Evaluating the impact of NICE guidelines for suspected cancers in respect of diagnostic interval and other outcomes
Datasets:GP data, NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-24
Organisations:
William Hamilton - Chief Investigator - University of Exeter
Anne Evelyn Spencer - Collaborator - University of Exeter
Georgios Lyratzopoulos - Collaborator - University College London ( UCL )
Obioha Ukoumunne - Collaborator - University of Exeter
Ruben Mujica Mota - Collaborator - University of Exeter
Sally Stapley - Collaborator - University of ExeterOutcomes:
Diagnostic interval, stage at diagnosis, treatment with curative intent, survival
Description: Technical Summary
The objectives of the study are to explore changes in diagnostic interval and diagnostic activity of cancers from 2000-2015, and to estimate the early impact of the NICE 2015 suspected cancers guidelines.
We will examine 13 cancers diagnosed since 2000: lung, oesophagus, stomach, pancreas, colorectal, breast, ovary, uterus, prostate, bladder, kidney, melanoma and myeloma. These cancers, including all the common ones, are those for which the 2015 guidelines made a major alteration in recommendations from the previous 2005 guidance, so the impact of the 2015 guidelines, should arise primarily within these 13 cancers. For other cancers, little or no change was made, and so we check this by studying a further 10 cancers to see if any change has arisen over the same time period.
We will use a difference in differences approach to estimate the impact of the new policy on outcomes for patients with NICE-qualifying symptoms relative to those without. Linear and quantile regression models will be fitted to compare the mean and quantile diagnostic interval between the cohorts, using tests of interaction to compare changes in our primary outcome, diagnostic interval, between presentation of NICE-qualifying symptom alone or in combination and presentation of non-NICE-qualifying symptom.
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Hyperglycaemia and early detection of pancreatic cancer — Christoph Meier ...
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Hyperglycaemia and early detection of pancreatic cancer
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-24
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Christoph Meier - Corresponding Applicant - University of Basel
Alexandra Muller - Collaborator - University of Basel
Cornelia Schneider - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes:
Pancreatic cancer
Description: Technical Summary
While new-onset diabetes mellitus can be a symptom of pancreatic cancer, only 1% of diabetic patients will develop the disease within 3 years after diabetes detection. Using a case-control design, we intend to characterise 30-89 years old patients with a first-time pancreatic cancer diagnosis and a matched comparison group without pancreatic cancer focusing particularly on their hyperglycaemia history. We will assess the timing of hyperglycaemia onset (</= or > 2 years prior to the cancer diagnosis) and the temporal pattern of blood glucose and HbA1c values up to 5 years prior to the cancer diagnosis or the corresponding date in the controls. We will classify blood glucose and HbA1c values into quartiles or into a priori defined categories of low, normal or high levels, and we will evaluate whether different categories are differentially associated with pancreatic cancer performing conditional logistic regression analysis. We will further compare body weight and BMI in hyperglycaemic pancreatic cancer and in control patients. Using conditional logistic regression analysis, we will assess the association between the risk of pancreatic cancer and changes in body weight by the time of cancer diagnosis.
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Investigating the utility of blood pressure variability in cardiovascular risk prediction — Richard Stevens ...
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Investigating the utility of blood pressure variability in cardiovascular risk prediction
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-10
Organisations:
Richard Stevens - Chief Investigator - University of Oxford
Richard McManus - Collaborator - University of Oxford
Sarah Lay-Flurrie - Collaborator - University of OxfordOutcomes:
Cardiovascular events; - Myocardial infarction - Coronary and ischaemic heart disease - Angina- Cerebrovascular and haemorrhagic stroke events- Cause-specific mortality
Description: Technical Summary
Recent research has suggested that BP variability may be an important risk factor for CVD (over and above mean), in particular variability in visit-to-visit BP measurements. However, although the additional prognostic value of BP variability has been demonstrated through survival analysis of long-term cohort and trial data, the utility of this factor in a risk prediction model has not been assessed. This study aims to develop two risk scores to predict future risk of CVD in individuals, one including traditional risk factors alone and a second additionally including BP variability as a risk factor. Both risk scores will be developed using data from adults without prior history of CVD, with linkage to mortality and hospital episodes data (to more accurately ascertain events) and deprivation data.
The risk scores will be developed in a derivation subsample using parametric survival models and fractional polynomials to model the relationship between traditional CVD risk factors and CVD outcomes. The accuracy of the two risk scores will be compared to each other in terms of discrimination, calibration and net reclassification index in a validation subsample.
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Low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride and diverse non-cardiovascular diseases: a large population-based cohort study using CALIBER dataset — Harry Hemingway ...
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Low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride and diverse non-cardiovascular diseases: a large population-based cohort study using CALIBER dataset
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-14
Organisations:
Harry Hemingway - Chief Investigator - University College London ( UCL )
Nat Na-Ek - Corresponding Applicant - Farr Institute of Health Informatics Research
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Amitava Banerjee - Collaborator - University College London ( UCL )Outcomes:
Incidence of diverse non-cardiovascular diseases (non-CVDs), including cataract, aged-related macular degeneration, Alzheimer's disease, Parkinson's disease, site-specific cancer, type 2 diabetes, liver cirrhosis, psoriasis, rheumatoid arthritis, multiple sclerosis, and systemic sclerosis in a large unselected population without pre-existing diseases of interest.
Time to first diagnosis of diseases listed above.Description: Technical Summary
Observational studies have shown that LDL, and HDL, cholesterol levels might be associated with some autoimmune disorders and some idiosyncratic adverse events. Due to limitations of existing evidence, however, the role of LDL, and HDL, cholesterol in non-cardiovascular diseases is still questioned. This observational study aims to examine the associations between LDL, HDL and the incidence of diverse non-cardiovascular diseases, including cataract, age-related macular degeneration, Alzheimer's disease, Parkinson's disease, type 2 diabetes, cirrhosis, psoriasis, rheumatoid arthritis, multiple sclerosis, and systemic sclerosis. Use of CALIBER data will allow us to investigate the full spectrum of LDL and HDL levels. We will include the population without pre-existing disease of interest whose LDL and HDL measurement was available during 1996 to 2000, and we will follow them up until the disease of interest occurred until 2010. Hazard ratios of the incidence of disease for each unit change in LDL and HDL will be calculated using time-dependent Cox proportional hazard models adjusted for potential confounders. We will also examine the role of age, gender as effect modifiers. The findings of this study will allow the investigator to conduct further research to understand more about the role of LDL and HDL cholesterol in non-cardiovascular diseases.
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Natural history, characteristics, and treatment patterns in patients with primary biliary cirrhosis and cholestatic pruritis — Julia DiBello ...
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Natural history, characteristics, and treatment patterns in patients with primary biliary cirrhosis and cholestatic pruritis
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-08
Organisations:
Julia DiBello - Chief Investigator - Merck & Co., Inc.
Kim Gilchrist - Collaborator - GSKOutcomes: none known
Description: Technical Summary
Primary biliary cirrhosis (PBC) is a relatively rare chronic cholestatic liver disease characterized by progressive bile-duct injury from portal and periportal inflammation resulting in progressive fibrosis and eventually cirrhosis. The two most common symptoms of the condition are fatigue and pruritus (itching), which are reported in more than 50% of symptomatic patients. Moderate to severe pruritus can impact activities of daily life and cause severe sleep deprivation resulting in lassitude, fatigue, depression and even suicidal ideation. The characteristics, natural history, and treatment patterns of PBC patients with cholestatic pruritus have not been well characterized in a large representative cohort. This study will provide information on the natural history of disease regarding the timing of occurrence of pruritus diagnoses in the diagnosed PBC population as well as the diagnosis of PBC and other liver conditions among those with pruritus/itching diagnoses, using Kaplan-Meier methods, in a relatively large and representative cohort of UK patients. Additionally, the treatment patterns and use of concomitant medications will be decribed in a contemporary cohort of prevalent PBC patients with and without cholestatic pruritus.
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Disease clusters and multimorbidity patterns: a UK population cohort study — Aroon Hingorani ...
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Disease clusters and multimorbidity patterns: a UK population cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-24
Organisations:
Aroon Hingorani - Chief Investigator - University College London ( UCL )
Valerie Kuan - Corresponding Applicant - University College London ( UCL )
Caroline Dale - Collaborator - University College London ( UCL )
Eda Bilici Ozyigit - Collaborator - University College London ( UCL )
Harry Hemingway - Collaborator - University College London ( UCL )
Jorgen Engmann - Collaborator - University College London ( UCL )
Juan Pablo Casas Romero - Collaborator - University College London ( UCL )
Matias Fuentealba - Collaborator - University College London ( UCL )
Rini Veeravalli - Collaborator - University College London ( UCL )
Rohan Takhar - Collaborator - University College London ( UCL )
Samuel Kim - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )
Stefanie Mueller - Collaborator - University College London ( UCL )Outcomes:
Multi-morbidity and related outcomes (including mortality)
Description: Technical Summary
We aim to describe disease patterns and within-person disease clusters in a representative sample of the UK population using electronic health records from 1997 to 2010 in the CALIBER (CArdiovascular research using LInked Bespoke studies and Electronic health Records) programme. Diseases will be aggregated into broad diagnosis groups modified from the Clinical Classifications Software (CCS) categorisation scheme developed by the Agency for Healthcare Research and Quality (AHRQ). Single and co-occurring prevalence rates for major diseases will be described by age, gender, ethnicity and deprivation index. Comorbidity scores that quantify the strength of disease co-occurrence will be calculated for disease pairs. Using the comorbidity score and p values based on the Benjamini-Hochberg false discovery rate, we will rank and select disease pairs which capture the highest correlations between different disorders. Patients will be stratified based on the similarity of their disease classifications using novel unsupervised machine learning methods involving clustering algorithms. This will allow us to identify the key disease characteristics in each cluster. We will then investigate which combination of key diagnoses lead to severe outcomes in the disease clusters using network analytic measures such as connectivity and lethality.
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Feasibility of using physician notes and discharge letters to assess potential benefits of early identification of subjects with cognitive deterioration — Noam Kirson ...
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Feasibility of using physician notes and discharge letters to assess potential benefits of early identification of subjects with cognitive deterioration
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-24
Organisations:
Noam Kirson - Chief Investigator - Analysis Group, Inc.
Alan Lenox-Smith - Collaborator - Eli Lilly & Co - UK
Carlos Martinez - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Catherine Reed - Collaborator - Eli Lilly & Co - UK
Grazia Dell'Agnello - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Howard Birnbaum - Collaborator - Analysis Group, Inc.
Jill Rasmussen - Collaborator - Not from an Organisation
Jody Wen - Collaborator - Analysis Group, Inc.
Mark Belger - Collaborator - Eli Lilly & Co - UK
Mark Meiselbach - Collaborator - Analysis Group, Inc.
Sarah King - Collaborator - Analysis Group, Inc.
Urvi Desai - Collaborator - Analysis Group, Inc.Outcomes: none known
Description: Technical Summary
The proposed study will assess the feasibility of using physician notes in combination with discharge letters and discharge summaries available to physicians to develop an algorithm to accurately identify the timing and results of cognitive and functional testing in CPRD data. Specifically, physician notes and select discharge letters/summaries will be requested for a random sample of 50 patients with confirmed AD diagnosis. Search algorithms will be developed to identify consultations containing information about whether a physician evaluated patientâs cognitive function either directly or through recording of information from the discharge summaries and/or reported the results of those assessments. The algorithm will be developed in two main steps. First, the physician notes as well as discharge letters/summaries will be reviewed manually and targeted key word searches will be conducted for a subset of 15 patients. Then, the findings of the preliminary analysis will be applied to the remaining patients. All text data will be reviewed for the entire sample to evaluate the rates of false positives and false negatives. In addition, the findings from the algorithm will be separately compared to those based on discharge letters/summaries and Read codes corresponding to cognitive assessments and symptoms of cognitive impairment.
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Risk of eczema in children: a population-based study — Sonia Gran ...
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Risk of eczema in children: a population-based study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-30
Organisations:
Sonia Gran - Chief Investigator - University of Nottingham
Sonia Gran - Corresponding Applicant - University of Nottingham
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Emma McManus - Collaborator - University of East Anglia
Katrina Abuabara - Collaborator - University Of California, San Francisco
Kim Thomas - Collaborator - University of Nottingham
Lu Ban - Collaborator - University of Nottingham
Miriam Santer - Collaborator - University of Southampton
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Tracey Sach - Collaborator - University of East AngliaOutcomes:
Incidence of eczema in children aged 0-17 years old
Description: Technical Summary
In the UK, contemporary estimates of eczema incidence in children are lacking and previous studies have shown inconsistent results due to different ways of measuring eczema. The aim of the project is therefore to assess the incidence of eczema in children in the UK. We will use the HES-linked CPRD records to establish an open cohort of children under the age of 18 years who have a first clinical diagnosis of eczema between April 1997 and March 2015. The study cases will be identified using various combinations of validated clinical diagnosis and treatments (including eczema-related drugs and phototherapy). Dr Abuabara is currently conducting a validation study of eczema diagnostic Read codes using data from The Health Improvement Network (SRC Reference Number: 14-083, Approved 15 January 2015, Study title: Eczema epidemiology and comorbidities). We will calculate crude incidence by dividing the number of cases by the total number of person-years from the HES-linked CPRD population at risk during the study period. We will calculate incidence stratified by age, sex, socioeconomic status, ethnicity and calendar year. We will also examine how the risk of eczema in children varies by calendar time, adjusted for age, sex, socioeconomic status and ethnicity.
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The risk of cardiovascular related death following cytomegalovirus (CMV) infection in England: an open cohort study using data from the Clinical Practice Research Datalink (CPRD) — Puja Myles ...
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The risk of cardiovascular related death following cytomegalovirus (CMV) infection in England: an open cohort study using data from the Clinical Practice Research Datalink (CPRD)
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-17
Organisations:
Puja Myles - Chief Investigator - CPRD
John Mair-Jenkins - Corresponding Applicant - Public Health England
Jonathan Van-Tam - Collaborator - University of Nottingham
Richard Puleston - Collaborator - University of NottinghamOutcomes:
Death from cardiovascular disease. Death from stroke and coronary heart disease
Description: Technical Summary
Cytomegalovirus (CMV) infection is highly prevalent (estimated seroprevalence 66-70%). There is mixed evidence of an association between CMV infection and death related to cardiovascular disease although the exact biological mechanisms remain unclear. This study will investigate this association using a large data set from the Clinical Practice Research Datalink (CPRD).
A retrospective cohort study will be conducted with a population aged over 45 years, registered with a CPRD practice between 2003 and 2013 (minimum one year of CPRD follow up and link to mortality data). CMV exposure will be defined as participants with a record of seropositivity or a CMV infection. Patients with negative CMV test results will form the unexposed group. This group may be supplemented with a random sample of people with no record of a CMV test following descriptive analysis. Office of National Statistics mortality data will be used to identify the deaths related to CVD, stroke or coronary heart disease.
Competing risks survival analysis will be used to quantify the risk of CVD, stroke or CHD death associated with CMV infection. Analyses will adjust for the potential confounding effects of age, sex, GP practice, geographical area, social deprivation, BMI >30, smoking status, comorbidities and inflammation.
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Predictors of complications of venous thromboembolism — Carlos Martinez ...
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Predictors of complications of venous thromboembolism
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-09
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)Outcomes: none known
Description: Technical Summary
Objectives
This study will investigate the predictors for recurrent VTE, bleeding and discontinuation of Vitamin K antagonists (VKA).
Methods
Observational cohort study of patients with a first VTE between January 2008 and March 2015 who are given VKA within 60 days of the initial VTE. The study cohort will be identified through the CPRD and HES.
Data analysis
Multivariate hazard ratios will be derived from Cox regression models comparing patients with the presence of a covariate with those without the covariate. The models will include time-dependent predictors, such as new provoking events or new comorbid conditions. The cohort of patients with a first VTE initially treated with VKAs will form the basis for all analyses.
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Child Outcome REVIEW Programme: Chronic Disability — Alison Kemp ...
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Child Outcome REVIEW Programme: Chronic Disability
Datasets:GP data, Cerebral palsy(CP) diagnosis Pattern of primary care consultations in children with CP Patterns of referral to secondary care and nature of hospital admissions in children with CP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-03-14
Organisations:
Alison Kemp - Chief Investigator - Cardiff University
Bethan Carter - Corresponding Applicant - Cardiff University
Ann John - Collaborator - Swansea University
Hywel M. Jones - Collaborator - Cardiff University
Melissa Wright - Collaborator - Cardiff University
Sophie Wood - Collaborator - Cardiff UniversityOutcomes:
Cerebral palsy(CP) diagnosis Pattern of primary care consultations in children with CP Patterns of referral to secondary care and nature of hospital admissions in children with CP
Description: Technical Summary
This healthcare assessment for children and young people with chronic disability has three main objectives. To explore:
1. the interface between different care settings for example primary and secondary care and health and social care;
2. the quality of care provision and
3. the transition between children and adult services.This study will include CYP resident in England, Wales, Scotland and Northern Ireland, aged 0-25 years and identified via routinely collected data sources (over a 10 year time period (2004-2014)).
CPRD data will be linked to Hospital Admissions data (HES) and ONS data, for patients in England, to describe the reasons for and frequency of primary and secondary care contact in CYP. This data will be compared to those without CP. The care interface between primary and secondary care will be explored. Patterns of healthcare will be examined based on age, gender and social deprivation. We are aware that not all linkages are possible for all UK countries.
Data will be analysed using summary statistics, relative risk ratios with 95% confidence intervals will be calculated and chi squared tests carried out as appropriate.
Source
2016 - 02
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Risk of hypoglycaemia in users of sulphonylureas with renal impairment: a population-based cohort study — Frank de Vries ...
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Risk of hypoglycaemia in users of sulphonylureas with renal impairment: a population-based cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-23
Organisations:
Frank de Vries - Chief Investigator - Utrecht University
Andre Krings - Collaborator - Atrium MC
Andrea Burden - Collaborator - ETH Zurich
Hubert Leufkens - Collaborator - Utrecht University
Johanna Driessen - Collaborator - Utrecht University
Judith van Dalem - Collaborator - Utrecht University
Martijn Brouwers - Collaborator - Maastricht UniversityOutcomes: none known
Description: Technical Summary
This study's objective is to evaluate the association between current use of sulphonylurea (SU) only and the risk of hypoglycaemia in relation to renal function, compared with current use of metformin-only. Within the CPRD, all adult patients with at least one prescription for non-insulin antidiabetic agents (NIAA) will be selected. The exposure of interest is use of SUs in patients with type 2 diabetes mellitus (T2DM) and renal impairment (RI). Current SU-only users will be stratified according to their most recent prescribed defined daily dose, most recent renal function and to type of SU (active vs. inactive metabolites).
Exposure will be assessed in a time-dependent manner. Adjusted cox regression models will be used to derive hazard ratios for the association between SU use, renal function and the risk of hypoglycaemia.
Source -
Depression, prescription of antidepressant drugs and changes in body weight: A cohort study using electronic health records — Martin Gulliford ...
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Depression, prescription of antidepressant drugs and changes in body weight: A cohort study using electronic health records
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-10
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Helen Booth - Collaborator - CPRD
Judith Charlton - Collaborator - King's College London (KCL)Outcomes: none known
Description: Technical Summary
Current research evidence on weight change alongside the use of antidepressants is limited by small sample sizes and short term reporting. Existing evidence suggests that antidepressant drugs can be associated with changes in body weight. The association between antidepressant use and weight change is complicated by the bidirectional relationship between depression and obesity. The present study will use the electronic health records of adults with at least three weight measurements to assess both short- and long-term body weight changes in patients who have been prescribed antidepressant drugs acutely and long-term. We will also investigate body weight changes after cessation of antidepressant use. Patients will be divided by their depression status using diagnostic medical codes and prescriptions of antidepressant drugs. In the face of a great need for care relating to both depression and obesity the results of this study will provide valuable information for health service planning and providers.
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Predicting first admission and readmission in heart failure patients — Alex Bottle ...
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Predicting first admission and readmission in heart failure patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-25
Organisations:
Alex Bottle - Chief Investigator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Martin Cowie - Collaborator - King's College London (KCL)
Paul Aylin - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
Our objectives are to identify the main predictors of emergency (re)hospitalisation in patients with heart failure and their relative importance. In this observational study with a retrospective cohort design, we will first identify in the linked CPRD-HES-ONS database each patient's first NHS contact for HF (either practice consultation or hospital admission) and take this as the diagnosis date and start of follow-up. All patients in the database up to March 2014 will be considered, taking into account patient and practice data quality flags, database follow-up, eligibility and coverage periods. Predictors will include demographics, comorbidities, frailty, physiology and medications. After descriptive analysis and an assessment of missing data, statistical methods will include survival analysis in a competing risks framework and multiple logistic regression, with forced entry of predictors where possible. We will explore the need for adjustment for clustering within practices.
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Bleeding Events and oral Anticoagulant Treatment in non-valvular atrial fibrillation (Heart-BEAT study): a cohort study based on CPRD-HES data — Cinira Lefevre ...
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Bleeding Events and oral Anticoagulant Treatment in non-valvular atrial fibrillation (Heart-BEAT study): a cohort study based on CPRD-HES data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-02
Organisations:
Cinira Lefevre - Chief Investigator - Bristol Myers Squibb - Europe ( BMS )
Andrew Maguire - Collaborator - OXON Epidemiology - Spain
Essra Ridha - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Laure Lacoin - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Michelle Johnson - Collaborator - Roche
Shuk-Li Collings - Collaborator - Pfizer Ltd - UK
Vicky Parsons - Collaborator - OXON Epidemiology - SpainOutcomes: none known
Description: Technical Summary
Objectives: To determine the rate of bleeding events and a composite outcome (including major bleeding events, thromboembolic events or all-cause mortality) following treatment initiation among patients with non-valvular atrial fibrillation (NVAF) newly prescribed apixaban, rivaroxaban, dabigatran and vitamin K antagonists. The study also aims to describe the patient characteristics, persistence rates and healthcare utilisation rates and costs of oral anticoagulant (OAC) use in patients with NVAF.
Methods: An observational cohort study of patients with NVAF newly prescribed OACs between 1st December 2012 and 31st December 2015 (or up to the most recent data available) during routine clinical practice in the UK identified with retrospective data from CPRD. The linked HES and ONS mortality data will also be used to assess bleeding events, the composite outcome and healthcare utilisation.
Data analysis: Overall rates and cumulative incidence rates, with 95% confidence intervals, will be calculated for bleeding events, the composite outcome and persistence rates. If there is sufficient power for the comparison of events, marginal Cox proportional hazards models will be used to compare time to event across the OACs, accounting for the competing risk of mortality (for bleeding events and persistence), intra-patient correlation, differences in patient characteristics and exposure time.
Source -
Evaluating the utility of the CPRD GOLD-HTI linkage: anticoagulant prescribing at the GP practice compared to hospital dispensed medication at discharge date — Arlene Gallagher ...
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Evaluating the utility of the CPRD GOLD-HTI linkage: anticoagulant prescribing at the GP practice compared to hospital dispensed medication at discharge date
Datasets:GP data, Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-10
Organisations:
Arlene Gallagher - Chief Investigator - CPRD
Adam Collier - Collaborator - IQVIA - UK
Hassy Dattani - Collaborator - EPIC UK
Rachel Tham - Collaborator - IQVIA Ltd
Tim Williams - Collaborator - CPRDOutcomes:
Anticoagulant prescribing at the GP practice
Description: Technical Summary
This study aims to demonstrate the utility of the linkage between CPRD primary care data (GOLD) and the HTI which links hospital dispensing information, events in hospital and the primary care data. To do this, anticoagulants (novel oral anticoagulants (NOACs) heparin and warfarin) have been chosen as an example medication that may be initiated in hospital and continued by the GP. The aim is to see if we can follow patients from one setting (hospital) to the next (primary care).
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Cancer Survival Programme and Early Diagnosis of Cancer — Bernard Rachet ...
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Cancer Survival Programme and Early Diagnosis of Cancer
Datasets:GP data, NCRAS Cancer Registration Data; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-16
Organisations:
Bernard Rachet - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Cristina Renzi - Collaborator - University College London ( UCL )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michel Coleman - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rachael Williams - Collaborator - CPRD
Thomas Chu - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Timothy Card - Collaborator - University of NottinghamOutcomes: none known
Description: Technical Summary
The main research objective is to produce population-based evidence for improving diagnosis and survival for cancer patients. Focusing on the pre-diagnostic phase and, on adult bowel cancer and brain tumours in children and young adults, we aim to evaluate the roles played by primary-care symptomatic presentations on (i) first, the risk of being diagnosed with the tumour during emergency admission, then, on (ii) the extend of the tumour and on survival from the tumour.
We will use an up-to-date version of linked datasets combining the national cancer data repository and CPRD. We will extract from that the relevant cancer patients with at least one year of CPRD records prior to cancer diagnosis.
We will primarily model the association between emergency diagnosis and symptoms/clusters of symptoms using logistic regression analysis, and the association between emergency diagnosis and consultation rates for relevant symptoms, using Poisson regression. We will account for patientsâ socio-demographic and clinical characteristics. Random effect will be considered to account for patient-level clustering of repeated symptoms. We will then estimate the associations of the symptoms patterns identified at this step with the extent of the disease and the survival from the disease, using multinomial/logistic regression and excess hazard model, respectively.
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The last year of life in COPD: prognostication, preparation, palliation — Jennifer Quint ...
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The last year of life in COPD: prognostication, preparation, palliation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-24
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Laura-Jane Smith - Corresponding Applicant - Imperial College London
Cosetta Minelli - Collaborator - Imperial College London
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Patrick Stone - Collaborator - UCL HospitalOutcomes: none known
Description: Technical Summary
We will use CPRD GOLD data linked with HES and ONS to investigate the recording of currently identified prognostic markers for COPD. We will identify patients within CPRD with validated Read codes for COPD and investigate factors associated with mortality. We will test any existing prognostic risk models which use factors which are routinely recorded in electronic health records. We will generate a novel prognostic model using a range of putative prognostic variables. We will use multivariate logistic regression and more advanced statistical methods, aiming to create a model with greater confidence for prediction of death in the year following the annual COPD check-up. More accurate risk stratification could assist communication, shared decision-making, and advance care planning.
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Does better quality of primary care influence admissions and health outcomes for people with serious mental illness (SMI)? A linked patient-level analysis of the full patient care pathway — Rowena Jacobs ...
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Does better quality of primary care influence admissions and health outcomes for people with serious mental illness (SMI)? A linked patient-level analysis of the full patient care pathway
Datasets:GP data, Rowena Jacobs - Chief Investigator - University of York
Anne Mason - Collaborator - University of York
Ceri Owen - Collaborator - Service User of MHLDDS
Christoph Kronenberg - Collaborator - University of York
Giuseppe Moscelli - Collaborator - University of York
Hugh Gravelle - Collaborator - University of York
Katja Grasic - Collaborator - University of York
Lauren Aylott - Collaborator - Service User of MHLDDS
Leonardo Koeser - Collaborator - University of York
Luis Fernandes - Collaborator - University of York
Maria Goddard - Collaborator - University of York
Maria Jose Aragon Aragon - Collaborator - University of York
Mark Wilson - Collaborator - University of York
Nigel Rice - Collaborator - University of York
Nils Gutacker - Collaborator - University of York
Panagiotis Kasteridis - Collaborator - University of York
Ruth Helstrip - Collaborator - University of York
Simon Gilbody - Collaborator - University of York
Tim Doran - Collaborator - University of York
Tony Kendrick - Collaborator - University of SouthamptonProcessing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-09
Organisations:
Rowena Jacobs - Chief Investigator - University of York
Anne Mason - Collaborator - University of York
Ceri Owen - Collaborator - Service User of MHLDDS
Christoph Kronenberg - Collaborator - University of York
Giuseppe Moscelli - Collaborator - University of York
Hugh Gravelle - Collaborator - University of York
Katja Grasic - Collaborator - University of York
Lauren Aylott - Collaborator - Service User of MHLDDS
Leonardo Koeser - Collaborator - University of York
Luis Fernandes - Collaborator - University of York
Maria Goddard - Collaborator - University of York
Maria Jose Aragon Aragon - Collaborator - University of York
Mark Wilson - Collaborator - University of York
Nigel Rice - Collaborator - University of York
Nils Gutacker - Collaborator - University of York
Panagiotis Kasteridis - Collaborator - University of York
Ruth Helstrip - Collaborator - University of York
Simon Gilbody - Collaborator - University of York
Tim Doran - Collaborator - University of York
Tony Kendrick - Collaborator - University of SouthamptonOutcomes: none known
Description: Technical Summary
In England, general practitioners (GPs) play a central role in the care of most people with serious mental illness (SMI). The Quality and Outcomes Framework (QOF) offers financial rewards to GP practices for good quality care, including payments for treating people with SMI.
Our key research question is whether better management of SMI in general practice improves health outcomes and health care utilisation for people with SMI. We will measure the quality of care using two methods: 1) indicators from the QOF; and 2) non-QOF quality measures also derived from primary care patient records. Our two outcome measures will include: 1) Number of A&E attendances (found in Hospital Episodes Statistics (HES) A&E data), and 2) Health of the Nation Outcome Scale (HoNOS) scores (found in Mental Health and Learning Disabilities Data Set (MHLDDS) data). We will use quantitative approaches (e.g. regression models, survival analysis, time-to-event analysis) to model the impact of the two types of quality indicators on the two outcome measures, conditional on a number of covariates which may affect A&E attendances and outcome scores.
We already hold a dataset of SMI patients (CPRD data protocol 14_168RMn) and we seek to link this to two non-standard linkages (HES A&E and MHLDDS) to answer the two research questions.
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A Study of Antibiotic Utilisation in Primary Care — Martin Gulliford ...
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A Study of Antibiotic Utilisation in Primary Care
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-10
Organisations:
Martin Gulliford - Chief Investigator - King's College London (KCL)
Martin Gulliford - Corresponding Applicant - King's College London (KCL)
Alex Dregan - Collaborator - King's College London (KCL)
Xiaohui Sun - Collaborator - King's College London (KCL)Outcomes:
Antibiotic utilisation for all indications in primary care
Description: Technical Summary
There is growing concern that unnecessary prescribing of antibiotics in primary care is leading to increasing antimicrobial drug resistance. We have previously reported on antibiotic utilisation for respiratory infections in primary care using CPRD data but overall antibiotic utilisation in CPRD has not been evaluated since the 1990s. In this study, we aim to estimate utilisation of antibiotics in primary care for all indications. We will analyse data for the most recent complete year in CPRD and the equivalent years 10 and 20 years previously. We will obtain data for all antibiotic prescriptions in the year. Using the CPRD denominator file, we will estimate age and sex specific antibiotic prescribing rates. We will also estimate proportions of registered populations that are exposed to antibiotic drugs during the year. We will also evaluate types of antibiotic drugs used. Estimates will be divided by region and deprivation category. This information will provide the background and context for a PhD thesis on the topic. It will also provide training in the use of CPRD data. The results will also provide up to date estimates of antibiotic use in primary care that can be communicated to professionals, policy-makers and members of the public.
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Validity of UK general practice prescribing safety indicators in predicting adverse events — Rupert Payne ...
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Validity of UK general practice prescribing safety indicators in predicting adverse events
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-25
Organisations:
Rupert Payne - Chief Investigator - University of Bristol
Rupert Payne - Corresponding Applicant - University of Bristol
Angela Wood - Collaborator - University of Cambridge
Ellie Paige - Collaborator - The Australian National University
Kirsty Rhodes - Collaborator - University of CambridgeOutcomes:
Total number of asthma exacerbation
events
Total number of heart failure exacerbation
events
Total number of diagnoses for gastrointestinal bleeding
Total number of diagnoses for acute kidney injury
Total number of diagnoses for falls
Total number of hospital admissions, and total number of hospital admissions for an adverse drug reactionDescription: Technical Summary
This study aims to examine the predictive validity of the published UK GP prescribing safety indicators for estimating the risk of adverse events and hospitalisations. CPRD data, linked to integrated HES data, will be used to examine the association between 12 different prescribing safety indicators, plus a composite indicator, and the risk of adverse events and hospitalisations. The primary outcome will be adverse events of interest related to the indicators, including asthma exacerbation events, heart failure exacerbation events, gastrointestinal bleeding, acute kidney injuries, and falls. Secondary outcomes of interest will include total number of hospitalisations and total number of hospitalisations with a diagnosis of an adverse drug reaction. People will be followed up commencing 1 January 2013 with the exposure groups to be defined using data from a 3-month exposure period prior to start of follow-up. The total number of events during follow-up in the exposed and unexposed groups will be compared using Poisson regression to investigate whether having a safety prescribing indicator increases the likelihood of having an adverse event.
Source - and 11 more projects — click to show
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Epidemiology of venous thromboembolism in patients with active cancer: a population-based cohort study — Carlos Martinez ...
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Epidemiology of venous thromboembolism in patients with active cancer: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-23
Organisations:
Carlos Martinez - Chief Investigator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London (KCL)
Anja Katholing - Collaborator - Institute for Epidemiology, Statistics and Informatics GmbH (Pharma Epi)Outcomes:
Cancer-associated venous thromboembolism All-cause mortality
Description: Technical Summary
The proposed study aims to estimate the incidence rate of first venous thromboembolism (VTE) in patients with active cancer, and the subsequent risk of recurrent VTE and mortality.
The study will follow a cohort design. One study cohort of patients with active cancer-associated first VTE will be derived from the active-cancer subset of a previously identified cohort of patients with a first VTE. A second cohort with cancer but without VTE will be derived separately.
Descriptive analyses will be conducted to estimate the incidence rates of first VTE in patients with cancer, and the incidence rates of recurrent VTE and all-cause mortality in patients with cancer-associated VTE, presented by cancer type. The cumulative risk of recurrent VTE over time will be derived accounting for mortality as a competing risk.
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Characterising the safety profile of lurasidone in clinical practice: A drug utilisation and safety study using a United Kingdom primary care database. — Andrew Maguire ...
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Characterising the safety profile of lurasidone in clinical practice: A drug utilisation and safety study using a United Kingdom primary care database.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-16
Organisations:
Andrew Maguire - Chief Investigator - OXON Epidemiology - Spain
Shreya Davé - Corresponding Applicant - Takeda Pharmaceuticals Company Ltd
Michelle Johnson - Collaborator - Roche
Shuk-Li Collings - Collaborator - Pfizer Ltd - UKOutcomes: none known
Description: Technical Summary
The overall study aim is to characterise the safety profile of lurasidone in UK primary care in comparison to other second generation antipsychotics (SGAs) through a descriptive drug utilisation study (DUS) and a comparative longitudinal post-authorisation safety study (PASS). The DUS will assess initiation of prescribing of lurasidone versus SGAs, and characterise patients with respect to demographics, comorbidities, comedications, and off-label prescribing. The PASS will assess incidence rates and rate ratios for safety outcomes in patients who are prescribed lurasidone versus other SGAs. Safety outcomes will include: mortality, extrapyramidal symptoms, angioedema, neuroleptic malignant syndrome, suicidality, cardiac disease, cerebrovascular accident, increased serum creatinine, renal impairment/failure, metabolic effects (hyperglycaemia, weight gain, dyslipidemia), rhabdomyolysis, agranulocytosis, and seizure. Subgroup analyses will be conducted in both components in the following sub-populations: patients with renal and hepatic impairment, the elderly, patients with cardiac impairment, those co-prescribed strong CYP3A inhibitors/inducers, and children/adolescents. Exploratory analyses will be conducted on exposure to SGAs in pregnant women. The safety of lurasidone with other antipsychotics will be also be assessed. Asthenia, as a safety outcome in the elderly as well as dose in the elderly will be studied.
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Comorbidity in the aging HIV population of the UK: a CPRD analysis. — Louise Watson ...
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Comorbidity in the aging HIV population of the UK: a CPRD analysis.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-23
Organisations:
Louise Watson - Chief Investigator - EpiPharmaCo
Eilish McCann - Collaborator - Merck & Co., Inc.
Ruth Farquhar - Collaborator - Exploristics
Ryan Dillon - Collaborator - Merck Sharp & Dohme - UKOutcomes: none known
Description: Technical Summary
The primary objectives in this three-part retrospective matched cohort database study of HIV+ve patients and matched controls (HIV-) are to: i) evaluate the prevalence of non-HIV related co-morbidities in HIV+ patient's compared to HIV- patients; ii) compare incidence of diseases over time; iii) identify risk factors for incident disease onset. Observation is from January 1st 2004 until December 31st 2014. Follow up is for a decade in 24 month epochs (x5). Outcomes are clinical and demographic characteristics at index date and over time, plus major co-morbidities reported per epoch with particular interest in cardiovascular disease (CVD); diabetes; neuro-psychiatric disease; respiratory diseases; primary neoplasms; non-hereditary renal disease plus hepatic and blood dyscrasias. Analyses will be: a) cross-sectional descriptive analyses of HIV+ and HIV- clinical characteristics and comorbidity diagnoses in the years 2004 and 2014; b) longitudinal follow up of patients describing prevalent co-morbidities and new diagnoses over the 10 year period; c) modelling risk factors for co-morbidity incidence over ten years follow-up including HIV status, age and interaction between the two. Individual repeated measures models will be developed for the four diseases that have the highest prevalence.
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Investigating the effects of commonly prescribed drugs on the prevention and treatment of Alzheimer's and other neurodegenerative diseases: are there drugs already available that can be repurposed? — Patrick Kehoe ...
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Investigating the effects of commonly prescribed drugs on the prevention and treatment of Alzheimer's and other neurodegenerative diseases: are there drugs already available that can be repurposed?
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-19
Organisations:
Patrick Kehoe - Chief Investigator - University of Bristol
Annie Sadoo - Collaborator - University of Bristol
Ciarrah-Jane Barry - Collaborator - University of Bristol
Luke McGuinness - Collaborator - University of Bristol
Neil Davies - Collaborator - University of Bristol
Richard Martin - Collaborator - University of Bristol
Venexia Walker - Collaborator - University of BristolOutcomes: none known
Description: Technical Summary
There is urgent need for new evidence about medications that could influence the incidence and progression of neurodegenerative diseases. One promising approach is to investigate drug repositioning, which offers a time- and cost-effective alternative to traditional drug development. A recent consensus study of dementia experts identified a short-list of individual and classes of prescribed drugs that may be repurposed as novel treatments for dementia. The short-list included compounds used to treat hypertension, hypercholesterolemia and type 2 diabetes, all of which could be classed as having 'cerebroprotective' properties and have variable levels of pre-clinical evidence that suggest they may have beneficial effects for various aspects of dementia pathology. However as yet there is limited pharmacoepidemiological data to support their effects in human populations.
Our primary aim, therefore, is to investigate whether these existing medications, previously identified as potentially cerebroprotective, could be repurposed to prevent or treat Alzheime''s disease and other types of dementia, amyotrophic lateral sclerosis and Parkinson's disease. We will conduct an observational cohort study to investigate the relationship of these medications with incidence and post-diagnosis survival of patients and at the same time identify to what extent any observed associations are altered when existing dementia therapies are co-administered. Collectively these findings will allow the prioritisation of drugs to be tested as repurposed treatments in clinical trials of these conditions in the future.
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Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study — Daniel Prieto...
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Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-25
Organisations:
Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Anne Felicity Thompson - Collaborator - National Osteoporosis Society ( NOS )
Antonella Delmestri - Collaborator - University of Oxford
Cyrus Cooper - Collaborator - University of Southampton
Daniel Dedman - Collaborator - CPRD
Denise Abbott - Collaborator - National Kidney Federation
Fergus Caskey - Collaborator - University of Bristol
Leena Elhussein - Collaborator - University of Oxford
Muhammad Javaid - Collaborator - University of Oxford
Nigel Arden - Collaborator - University of Oxford
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Yoav Ben-Shlomo - Collaborator - University of BristolOutcomes: none known
Description:
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Serum creatinine elevation following renin-angiotensin-aldosterone system blockade, adherence to monitoring and discontinuation guidelines, and long-term cardiorenal risks — Laurie Tomlinson ...
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Serum creatinine elevation following renin-angiotensin-aldosterone system blockade, adherence to monitoring and discontinuation guidelines, and long-term cardiorenal risks
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-16
Organisations:
Laurie Tomlinson - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Morten Schmidt - Corresponding Applicant - Aarhus University Hospital
Dorothea Nitsch - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Henrik Toft Sorensen - Collaborator - Aarhus University
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes:
First event during follow-up identified from HES and CPRD; end stage renal disease, worsening of renal function, myocardial infarction, heart failure, mortality (all-cause), and major adverse cardiovascular events (composite of death, myocardial infarction, and heart failure)
Description: Technical Summary
We will use the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) to identify all adult new users of ACEi/ARBs, who started treatment between April 1997 and March 2014 and who attended primary care practices contributing to CPRD. Among these patients, we will describe monitoring patterns, i.e., the proportion with pre- and post-initiation SCr measurements at different time points, average changes in SCr and electrolyte levels after initiation, and the proportion continuing treatment (receiving a 2nd or 3rd prescription) for different levels of increases. Among continuous ACEi/ARB users, we will then use Poisson regression, with adjustment for potential confounders, to estimate incidence rate ratios as measures of the association between categories of SCr increase and end-stage renal and cardiovascular diseases (myocardial infarction and heart failure). We will examine the robustness of our results through several sensitivity analyses and stratify on cardiorenometabolic comorbidities.
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Using Linked Primary and Secondary Care Data to Explore Complex Pathways Through Complex Systems for Patients with Long-Term Conditions — Jan van der Meulen ...
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Using Linked Primary and Secondary Care Data to Explore Complex Pathways Through Complex Systems for Patients with Long-Term Conditions
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-11
Organisations:
Jan van der Meulen - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Andrew Hutchings - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
John Robson - Collaborator - Queen Mary University of London
Kambiz Boomla - Collaborator - Barts and the London Queen Mary's School of Medicine and Dentistry
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
The proposed study will examine methodological issues in using linked primary (CPRD) and secondary care data (HES) for describing variation in patterns of NHS care for patients with one or more of nine long-term conditions. Diagnosis of the LTCs from the different data sources will be made using established coding methods to examine consistency between CPRD and HES and identify patient and organisational factors associated with inconsistent records. Longitudinal records of NHS care utilisation will be created in order to describe and examine variation in the utilisation of different types of care (GP appointments, hospital outpatient attendances and hospital admissions) for cohorts of patients with the long-term conditions. The study will examine potential methodological issues in using linked data for this purpose by assessing, as far as is possible, the consistency and completeness of utilisation data and the way that utilisation varies depending on how cohorts are identified.
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Demography and pattern of causes of death in recognised alcohol misusers in the English General Practice (GP) population — Timothy Card ...
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Demography and pattern of causes of death in recognised alcohol misusers in the English General Practice (GP) population
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-10
Organisations:
Timothy Card - Chief Investigator - University of Nottingham
Abdul-Rahman Abdul-Kareem - Corresponding Applicant - University of Nottingham
Kate Fleming - Collaborator - University of LiverpoolOutcomes: none known
Description: Technical Summary
The mortality patterns of the alcohol misusing population have been relatively under-explored. This hinders the planning of health services that are tailored to the health needs of this population. We aim to contribute to reducing this knowledge gap by conducting a cohort study of recognised alcohol misusing, non-drinking, low-risk drinking and the general populations in the CPRD dataset. We will provide descriptive epidemiological information on the numbers, prevalence and basic demographic characteristics of these groups. We intend to report the all-cause and cause-specific mortality rates (as hazards and risk), as well mortality rate ratios of alcohol misusing categories relative to other populations.
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Use of routinely collected national data to determine the delays that lead to poor outcome for cancer patients in the UK — Paul Ziprin ...
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Use of routinely collected national data to determine the delays that lead to poor outcome for cancer patients in the UK
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-18
Organisations:
Paul Ziprin - Chief Investigator - Imperial College London
Chanpreet Arhi - Corresponding Applicant - Imperial College London
Ara Darzi - Collaborator - Imperial College London
George Bouras - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
Survival following cancer diagnosis in the UK is lower compared to other Western and Northern European countries. The symptomatic patient pathway begins with the first symptom, and involves clinical events such as the first GP consultation, hospital appointments, investigations, and treatment. Our hypothesis is that detrimental events during the patients diagnosis and treatment lead to delays, causing the poor 1-year survival seen in the UK. Our aim is to identify the causes of these delays by analysing CPRD linked data - GP consultations, HES admissions, NCIN cancer dataset and ONS mortality data. CPRD is the largest source of routinely collected information available in the UK. Studies have shown CPRD is a reliable source of consultation dates, co-morbidities, complications, medications and cancer diagnoses. Further information regarding chemo-/radiotherapy and complications following surgery can be identified in HES. However, CPRD linked data is limited as the length of symptoms before consultation and outpatient data is not routinely available.
For the purpose of this study, the patient pathway will be split into before and after diagnosis. We will determine the effect of the type of symptom, co-morbidity, demographics and geographical location on a delay in diagnosis, and how this effects survival. Following diagnosis, the type of operation (if relevant), stage of tumour, co-morbidities and complications will be used in multilevel regression modelling to determine the effect on survival.
The date of diagnosis will be determined on a hierarchal level of evidence as set out by the International Association of Cancer Registries, with first histological confirmation being the preferred date of diagnosis.
Our study population criterion is any patient over the age of 18 that has a diagnosis of colorectal, breast, prostate, oesophogastric or lung cancer in the NCIN cancer dataset, and has linked data in CPRD.
Patients who survive beyond one year after diagnosis will act as controls, as previous studies have shown the largest difference in survival between the UK and northern Europe occurs in the first 12 months. Secondary analysis will compare patients who have had a curative resection to those who have not, as the latter will be used as a surrogate for palliative treatment. A third analysis will compare patients diagnosed electively vs. emergency, as the latter group are known to have a worse survival. Previous studies that have attempted to test this hypothesis using local datasets or notes have not been able to include sufficient patient numbers and confounders.
The accuracy of HES has been previously verified, by comparing to patient notes. Analysis of the CPRD data from within our department has demonstrated there is sufficient number of clinical episodes regarding cancer symptoms before diagnosis, and complications in the community following treatment. A similar process has also been carried out for CPRD and is described in a systematic review. This latter publication found a median of over 95% (range 74-100) concordance for cancer related diagnoses. A concordance of 83% has also been noted when CPRD has been compared to the cancer registry. Although there remains a possibility of missing clinical episodes, these publications suggest such occurrences should be low.
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Drospirenone-containing combined oral contraceptives and risk of venous thromboembolism — Samy Suissa ...
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Drospirenone-containing combined oral contraceptives and risk of venous thromboembolism
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-10
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Janie Coulombe - Collaborator - McGill University
Natasha Larivee - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Vicky Tagalakis - Collaborator - McGill UniversityOutcomes: none known
Description: Technical Summary
Although several studies have examined the association between use of drospirenone-containing combined oral contraceptive (COCs) and the risk of venous thromboembolism (VTE), these studies had several important limitations, including confounding by history of oral contraceptive use, the use of inappropriate comparators, and outcome misclassification. Given the substantial number of women taking these contraceptives and the limitations of the existing literature, there remains a need for additional studies of this association. Using the CPRD, linked to Hospital Episode Statistics (HES; inpatient and outpatient), we will conduct a retrospective cohort study of all initiators of drospirenone- or levonorgestrel-containing COCs between May 1st, 2002 and March 31st, 2015. The date of the first drospirenone- or levonorgestrel-containing COCs prescription will define cohort entry. Initiators will be followed until incident VTE (defined by an inpatient diagnosis of VTE or outpatient diagnosis of VTE with either a prescription for anticoagulant therapy, INR testing, or death) or censoring due to discontinuation of use, switching to any other form of hormonal contraception, arterial thromboembolism (ATE), death, departure from the CPRD or HES, or the end of the study period (March 31st, 2015), whichever occurs first. Analyses will involve Cox proportional hazards models with high dimensional propensity scores.
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Association between HbA1c and all-cause mortality in people with type 2 diabetes treated with glucose-lowering therapies with a higher and lower risk of inducing hypoglycaemia: a retrospective cohort study. — Craig Currie ...
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Association between HbA1c and all-cause mortality in people with type 2 diabetes treated with glucose-lowering therapies with a higher and lower risk of inducing hypoglycaemia: a retrospective cohort study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-02-23
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
A U-shaped association between glycated haemoglobin (HbA1c) and all-cause mortality has been demonstrated previously. An increased risk of hypoglycaemia could explain the increased risk of all-cause mortality associated with low HbA1c values. We will use a retrospective cohort study design. The objective of this study is to explore the association between HbA1c and all-cause mortality in patients with type 2 diabetes treated with glucose-lowering therapies associated with a higher risk of causing hypoglycaemia (insulin, meglitinides and sulfonylureas as monotherapy or in combination with other glucose-lowering therapies) and those treated with glucose-lowering therapies associated with a lower risk of causing hypoglycaemia (acarbose, metformin, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 agonists and thiazolidinediones as monotherapy or in combination with other glucose-lowering therapies excluding insulin, sulfonylureas or meglitinides).
Regimens initiated between 1 January 2004 and 31 December 2014 will be selected. HbA1c will be modelled as 12 monthly updated time-dependent mean and cumulative mean values. Cox proportional hazards models will be used to explore the association between HbA1c and all-cause mortality within each regimen of interest.
Source
2016 - 01
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Maternal Depression and Antidepressant Use During Pregnancy and Risk of Childhood Autism Spectrum Disorders (ASD) in Offspring: Population-based Cohort and Bidirectional Case-Crossover Sibling Study — Susan Jick ...
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Maternal Depression and Antidepressant Use During Pregnancy and Risk of Childhood Autism Spectrum Disorders (ASD) in Offspring: Population-based Cohort and Bidirectional Case-Crossover Sibling Study
Datasets:GP data, CPRD Mother-Baby Link
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-12
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Lin Li - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes: none known
Description: Technical Summary
Using the Mom-Baby linkage, we will conduct a cohort study of maternal depression and prenatal antidepressant medication use during pregnancy and the risk of ASD in children. We will consider three exposure categories; a) Antidepressant and Depression Exposed, b) Depression Only Exposed, and c) Antidepressant Only Exposed, each compared to a matched (4:1) unexposed cohort of women who have neither depression nor use of antidepressant medications. Defining the exposed cohort in this way will allow for independent evaluation of the effects of depression, the combined effect of antidepressants and depression, and the effect of antidepressants in the absence of depression on the risk of ASD in offspring. We will calculate cumulative incidence rates (IRs) of ASD and corresponding 95% confidence intervals (CIs). We will also conduct a âwithin-mother-between-pregnancyâ nested case-crossover sibling analysis to estimate odds ratios (ORs) and corresponding 95% CIs for the association between maternal prenatal antidepressant use and risk of ASD in the offspring. Motherâs age, sex, calendar time, and other potential confounders identified in the main analysis will be included in the regression model. We will examine confounding for a wide variety of additional medical and behavioral covariates using matching, stratification, and multivariable analysis.
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Risk factors for influenza-related complications in children — Kay Wang ...
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Risk factors for influenza-related complications in children
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-14
Organisations:
Kay Wang - Chief Investigator - University of Oxford
Antonis Kousoulis - Collaborator - Mental Health Foundation
Christopher Butler - Collaborator - University of Oxford
Clare Bankhead - Collaborator - University of Oxford
Joseph Lee - Collaborator - University of Oxford
Ruth Allanson - Collaborator - South Central Ambulance ServiceOutcomes: none known
Description: Technical Summary
Objective: To identify risk factors for influenza-related complications in children presenting with influenza/influenza-like illness (ILI) in the community.
Study design: Cohort study.
Study population: Children aged 0 to 17 years inclusive who presented with influenza/ILI in CPRD general practices during the 2009/10 influenza pandemic (27th April 2009 to 23rd May 2010).
Outcomes: Our primary outcome will be influenza-related complications within 30 days of presentation with influenza/ILI. Secondary outcomes will be pneumonia, influenza-related complications requiring further intervention (prescription of medication, referral for further investigation, or hospitalisation), hospitalisations or deaths due to influenza-related complications, and all cause hospitalisations and deaths within 30 days of presentation with influenza/ILI.
Data analysis: We will examine the association between potential risk factors and our proposed outcomes using logistic regression techniques to calculate odds ratios with 95% confidence intervals, both unadjusted and adjusted for possible confounders, including age, sex, and vaccination status. We will define potential risk factors as specific underlying conditions where possible. However, for rare conditions, we will combine data to create broader system-based disease categories.
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Temporal Trend of Severe Hypoglycaemia and Diabetic Ketoacidosis and the Relationship Between HbA1c or HbA1c variability and Risk of Severe Hypoglycaemia and Diabetic Ketoacidosis — Elizabeth J. Mayer...
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Temporal Trend of Severe Hypoglycaemia and Diabetic Ketoacidosis and the Relationship Between HbA1c or HbA1c variability and Risk of Severe Hypoglycaemia and Diabetic Ketoacidosis
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-28
Organisations:
Elizabeth J. Mayer-Davis - Chief Investigator - University of North Carolina at Chapel Hill
Victor Zhong - Corresponding Applicant - University of North Carolina at Chapel Hill
Christina Shay - Collaborator - University of North Carolina at Chapel Hill
Evangelos Kontopantelis - Collaborator - University of Manchester
Juhaeri Juhaeri - Collaborator - SANOFI
Penny Gordon-Larsen - Collaborator - University of North Carolina at Chapel Hill
Stephen Cole - Collaborator - University of North Carolina at Chapel HillOutcomes: none known
Description: Technical Summary
Objective 1 is to describe the longitudinal trend of annual incidence rate of severe hypoglycaemia in patients with T1D or T2D. Annual incidence rate will be computed using Poisson regression. To investigate the trend over the study period, we will fit a Poisson regression model with year variables, adjusting for necessary covariates. We may further determine, if the temporal trend varies by age, sex, and duration of diabetes. Confidence intervals will be derived from a bootstrap method where the sample error can be more reliably modelled.
Objective 2 is to determine the relationship between HbA1c and its variability and risk of severe hypoglycaemia between patients with T1D and T2D, and to determine whether the relationship varies over time or by diabetes type. Incidence density sampling will be used to select controls matched to case on index date, age, gender, general practitioner (GP) and number of years in the database with 10:1 ratio. Conditional logistic models will be applied, adjusted for potential confounders. To assess the temporal trend of the association, we will add years variables and the interaction terms between years with HbA1c variables.
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Assessing the Management and Clinical Outcomes of Patients with Non-Diabetic Intermediate Hyperglycaemia in UK Primary Care — Christopher Millett ...
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Assessing the Management and Clinical Outcomes of Patients with Non-Diabetic Intermediate Hyperglycaemia in UK Primary Care
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-22
Organisations:
Christopher Millett - Chief Investigator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Eszter P Vamos - Collaborator - Imperial College London
Mahsa Mazidi - Collaborator - Imperial College London
Raffaele Palladino - Collaborator - Imperial College London
Utz Pape - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
Non-diabetic intermediate hyperglycaemia is increasingly being identified and managed in primary care settings in the UK through the NHS Health Check and Diabetes Prevention Programme. However, little is known about whether the identification of intermediate hyperglycaemia improves health outcomes in routine care settings. The study aims to characterise and assess current practice for diabetes screening and identification of intermediate hyperglycaemia in UK primary care. It also aims to determine the impact of the diagnosis of intermediate hyperglycaemia on testing and control of cardiovascular disease (CVD) risk factors (i.e. HbA1c, blood pressure, and total cholesterol), hospital admissions for specific CVD events and all-causes and CVD-specific mortality. The study will use Clinical Practice Research Datalink (CPRD) data to construct a retrospective open cohort of patients aged 40-74 years with intermediate hyperglycaemia. In order to match cases and controls we will generate propensity scores for having a diagnosis of intermediate hyperglycaemia using multiple logistic or probit regression method. Mixed-effect logistic regression will be used for binary outcomes, linear mixed model for linear outcomes and mixed-effect Poisson regression model for count outcomes. Cox proportional hazards models will be used for survival analyses. Difference in differences methods will be employed as additional robustness test.
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Burden of Multiple Myeloma (MM) in England: regional equity based on Real world data from CPRD HES, and Cancer Registry linked data. — Iftekhar Khan ...
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Burden of Multiple Myeloma (MM) in England: regional equity based on Real world data from CPRD HES, and Cancer Registry linked data.
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; NCRAS Cancer Registration Data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-14
Organisations:
Iftekhar Khan - Chief Investigator - King's College London (KCL)
Andrew Jones - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Anthony Wesselbaum - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Cinira Lefevre - Collaborator - Bristol Myers Squibb - Europe ( BMS )
Hok Pang - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
James Harrison - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )Outcomes: none known
Description: Technical Summary
The objective of this study to interrogate the relationship between mortality (survival), age, geographical factors and the probability of access to anti-cancer therapy in MM patients. This study will also determine whether inequalities of access to anti-cancer treatments exist in England. Statistical models (including flexible parametric models) will be used to compare mortality rates across several factors including demographic, geographic and prognostic factors (e.g. Stage, Histology).
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Domperidone and risk of primary liver cancer in the UK Clinical Practice Research Datalink — Katherine McGlynn ...
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Domperidone and risk of primary liver cancer in the UK Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-04
Organisations:
Katherine McGlynn - Chief Investigator - National Institutes of Health - USA
Katherine McGlynn - Corresponding Applicant - National Institutes of Health - USA
Baiyu Yang - Collaborator - Roche
Barry I Graubard - Collaborator - National Cancer Institute ( NCI )Outcomes: none known
Description: Technical Summary
We aim to conduct a case-control study to assess the association between use of domperidone and the subsequent development of liver cancer among individuals in the CPRD. We will identify all eligible primary liver cancer cases in this population, and controls will be matched to cases at a 4:1 ratio on age, sex, general practice, and length of time in the CPRD. Ever-use of domperidone will be defined as having at least 2 prescriptions during the study period, and non-use will be defined as having 0 or 1 prescriptions during the study period. We will additionally classify use of domperidone according to duration and total number of prescriptions received. We will use conditional logistic regression to assess crude and adjusted risk estimates (odds ratios [ORs] and 95% confidence intervals [CIs]) for use of domperidone and the risk of developing liver cancer. In addition to variables controlled through matching, a comprehensive list of potential confounders will be evaluated.
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Statin use and incident Achilles or biceps tendon rupture — Christoph Meier ...
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Statin use and incident Achilles or biceps tendon rupture
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-28
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Julia Spoendlin - Corresponding Applicant - University of Basel
J. Bradley Layton - Collaborator - RTI Health Solutions
Mallika Mundkur - Collaborator - Brigham & Women's Hospital
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes: none known
Description: Technical Summary
We aim to perform a propensity-score matched sequential cohort study to assess the relative risk of Achilles and biceps tendon ruptures associated with statin use. Exposed and unexposed patients will be matched on their propensity score within 2-year enrolment blocks in order to avoid time trend bias. After concatenating all patients into one cohort, patients will be followed for a maximum of 5 years until they have a record for Achilles or biceps tendon rupture, or until they are censored. Subgroup analyses will be performed in men and women separately, in different age groups, as well as in terciles of follow up (as proxy for the cumulative statin dose). We will apply Cox proportional hazard analyses to calculate hazard ratios with 95% confidence intervals. The proposed study will be one of the largest observational studies assessing the risk of tendon rupture in association with statin use, the first applying thorough control for confounding by indication by means of propensity score matching, and the first using data from the CPRD.
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The risk of Clostridium Difficile Colitis and of pneumonia in persons with pernicious anaemia. — Timothy Card ...
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The risk of Clostridium Difficile Colitis and of pneumonia in persons with pernicious anaemia.
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-12
Organisations:
Timothy Card - Chief Investigator - University of Nottingham
Fatmah Othman - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of NottinghamOutcomes: none known
Description: Technical Summary
The aim of this study is to determine the risk of pneumonia and Clostridium difficile diarrhoea in patients with pernicious anaemia. This is a retrospective cohort study conducted in CPRD and utilising linked HES data where available. The exposed group will be patients who have a diagnosis of pernicious anaemia and who have been treated with vitamin B12 therapy. Exposed patients will be matched with ten non-pernicious anaemia patients in terms of age, gender, and general practice. Pneumonia and Clostridium difficile are the primary outcomes in this study. Cox regression analysis will be used to determine the hazard ratio for the associated outcome with pernicious anaemia. Potential confounders will be controlled in the Cox regression analysis.
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Treatment of first-time traumatic anterior shoulder dislocation (UK.TASH-D Study) — Jonathan Rees ...
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Treatment of first-time traumatic anterior shoulder dislocation (UK.TASH-D Study)
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Townsend Score
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2016-01-22
Organisations:
Jonathan Rees - Chief Investigator - University of Oxford
Amar Rangan - Collaborator - South Tees Hospitals
Andrew Carr - Collaborator - University of Oxford
Andrew Judge - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Gary Collins - Collaborator - University of Oxford
Nigel Arden - Collaborator - University of Oxford
Rafael Pinedo-Villanueva - Collaborator - University of Oxford
Sally Hopewell - Collaborator - University of Oxford
Sarah Lamb - Collaborator - University of Oxford
Tim Holt - Collaborator - University of OxfordOutcomes: none known
Description: Technical Summary
Aims. To study the association between surgical treatment to no surgery and recurrence rates following first time TASD in young adults; and identify predictors of recurrent dislocations stratified by treatment. We will also estimate any economic burden identified with TASD management.
Data sources: Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES).
Population: 10,449 patients aged 16-35 years in CPRD with TASD and two years follow up.
WP1: Internal and external validation of shoulder dislocation coding and treatments within a routinely collected dataset (CPRD).
WP2: Propensity score-matched cohort study using linked CPRD and HES. All events and outcomes will be collected using a pre-agreed list of READ CODES (CPRD) and OPCS 4.7 CODES (HES).
Exclusions: Surgery after more than one dislocation; instability treated with a rotator cuff repair or fracture surgery.
Intervention: Surgical repair within 6 months of first time TASD.
Control: non-surgical intervention.
Outcomes: Rate of re-dislocation, identified by codes in CPRD for 2 years after either treatment.
Sample size: 3065 with 656 expected total number of re-dislocations (90% power, 5% significance).
Statistical analysis: Propensity scores, Cox regression modelling and Rosenbaum bounds sensitivity analysis for Surgical versus non-surgical intervention on re-dislocation. Multiple imputation methods, survival models and fractional polynomials for Predictors of recurrent dislocations
Source
2015 - 12
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Psychological stress and risk of herpes zoster — Sinead Langan ...
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Psychological stress and risk of herpes zoster
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-22
Organisations:
Sinead Langan - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sigrun Alba Johannesdottir Schmidt - Corresponding Applicant - Aarhus University Hospital
Harriet Forbes - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Henrik Carl Schonheyder Pedersen - Collaborator - Aalborg University Hospital
Henrik Carl Schonheyder Pedersen - Collaborator - Aalborg University Hospital
Henrik Toft Sorensen - Collaborator - Aarhus University
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Mogens Vestergaard - Collaborator - Aarhus University
Sara Thomas - Collaborator - Not from an OrganisationOutcomes: none known
Description: Technical Summary
We will use CPRD and HES data to conduct a case-control study of the association between psychological stress and the risk of herpes zoster.
We will identify all adults with a first-time diagnosis of herpes zoster between 2000 to 2014. We will use incidence density sampling to select four controls per case matched by age, sex and practice. The date of herpes zoster diagnosis will be considered the index date for cases and their matched controls.
We will identify history of partner bereavement, depressive disorder, anxiety disorder, and stress or adjustment disorder prior to index date. We will categorise bereavement according to whether the partner death was foreseen, as measured by the age-adjusted Charlson Comorbidity Index and codes indicating terminal disease. For the psychiatric diagnoses, we will categorise severity as severe (requiring inpatient admission), moderate (requiring referral to other mental health service) or mild (remaining patients) based on healthcare records within 90 days before index date.
Using conditional logistic regression, we will compute odds ratios with 99% confidence intervals for the association between each psychological stressor and herpes zoster adjusting for risk factors for herpes zoster. We will examine the robustness of our results through several sensitivity analyses.
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Novel Prediction Models for the One-Year Competing Risks of Death, Stroke, Intracranial Hemorrhage, and Extracranial Hemorrhage in Adults with Incident Non-Valvular Atrial Fibrillation — Jason Fine ...
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Novel Prediction Models for the One-Year Competing Risks of Death, Stroke, Intracranial Hemorrhage, and Extracranial Hemorrhage in Adults with Incident Non-Valvular Atrial Fibrillation
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-23
Organisations:
Jason Fine - Chief Investigator - University of North Carolina at Chapel Hill
Todd Durham - Corresponding Applicant - IQVIA - USA (Headquarters)
Anthony Viera - Collaborator - University of North Carolina at Chapel Hill
Jayanti Mukherjee - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Kristen Hasmiller Lich - Collaborator - University of North Carolina at Chapel Hill
Stacie Dusetzina - Collaborator - University of North Carolina at Chapel HillOutcomes: none known
Description: Technical Summary
Treatment decisions in atrial fibrillation (AF) are often guided by risk stratification schemes for stroke and warfarin-associated bleeding. However, these schemes have limited utility in the era of target-specific oral anticoagulants (TSOAC). The objectives of this study are to develop and validate new prediction models for the one-year competing risks of a first event among death, stroke, intracranial hemorrhage, and extracranial hemorrhage while also accounting for treatment change as a competing event. To address these objectives, we will estimate the associations between previously-identified predictors and the four clinical events in a cohort of patients with incident non-valvular AF for whom oral anticoagulants may be appropriate. The index date will be 90 days after AF diagnosis, a landmark chosen based on previous work. The dependent variables include the times from index date to all-cause death, ischemic stroke, intracranial hemorrhage, extracranial hemorrhage, and change in treatment status. Independent variables include treatment at index (none, warfarin, dabigatran, rivaroxaban, and apixaban), predictors of stroke, predictors of major bleeding, and concurrent medications. Fine-Gray regression models will be used with a variable selection procedure to estimate the associations. The validity (fit) of the models will be assessed using concordance statistics. Illustrative individual predictions will be reported.
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Use of Finasteride 1mg for Alopecia and the Incidence of Erectile Dysfunction (ED) — Susan Jick ...
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Use of Finasteride 1mg for Alopecia and the Incidence of Erectile Dysfunction (ED)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-02
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Hozefa Divan - Collaborator - NERI - New England Research Institutes, Inc.
Lin Li - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Marissa Suh - Collaborator - NERI - New England Research Institutes, Inc.Outcomes: none known
Description: Technical Summary
We will conduct a cohort study with a nested case-control analysis to examine the association between finasteride 1mg use in men with alopecia and erectile dysfunction (ED). We will identify a cohort of men with alopecia, aged 18-59, with no history of sexual dysfunction prior to cohort entry. The incidence of ED among men with exposure to finasteride 1mg (the exposure of interest) will be compared to the incidence of ED among men with no such prescriptions. Crude and adjusted incidence rates (IRs) and 95% confidence intervals (CIs) and incidence rate ratios (IRRs) will be calculated for each exposure category (unexposed and finasteride 1mg exposed). IRs will be calculated as the number of incident events divided by exposed person-time. We will also conduct a nested case-control analysis to control for calendar time, age, and general practice. We will estimate crude and adjusted odds ratios (ORs), an approximation of the relative risk, and 95% CIs for ED in relation to use of 1 mg finasteride compared to unexposed, using conditional logistic regression with multivariable adjustment for identified covariates of importance. This study will provide information on the safety of finasteride 1mg prescribed to healthy young men for treatment of alopecia (also known as male patterned baldness).
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Clinical & Economic Burden of Diabetic Foot Ulcer Care Pathways in the UK — Samuel Aballea ...
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Clinical & Economic Burden of Diabetic Foot Ulcer Care Pathways in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-03
Organisations:
Samuel Aballea - Chief Investigator - Creativ-Ceutical
Julie Dorey - Corresponding Applicant - Creativ-Ceutical
David Neasham - Collaborator - Amgen LtdOutcomes: none known
Description: Technical Summary
Objective:
To describe the population, the complications, the healthcare pathways, the resource uses (RU) and associated costs of DFU patients comparatively to diabetic non DFU patients.
Methodology:
A retrospective longitudinal matched-cohort study using data from the CPRD and linked Hospital Episode Statistics (HES) database will be conducted. Patients with a diagnosis of DFU or DM with no DFU will be included. The DFU population will be matched to the DM with no DFU population to have an accurate evaluation of costs that are attributable to DFU. Subgroups analyses will be performed for several health states and subpopulations e.g. patients with the first ulcer and with a recurrent ulcer.
Data analysis:
Descriptive analyses of patients' characteristics, complications, healthcare pathways will be performed using standard descriptive statistics for continuous variables (N, mean, standard deviation, etc) and for categorical variables (frequency tables). Risk of complications will be studied using adjusted logistic regression. Kaplan-Meier curves will be provided for time to complications. The effect on time to events will also be investigated using Cox regression, to adjust on patient characteristics and clinical history. Costs of DFU will be calculated as the sum of unit costs multiplied by the estimated quantities of resource use.
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Bile duct and gallbladder diseases associated with the use of incretin-based drugs in patients with type 2 diabetes — Samy Suissa ...
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Bile duct and gallbladder diseases associated with the use of incretin-based drugs in patients with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-07
Organisations:
Samy Suissa - Chief Investigator - McGill University
Laurent Azoulay - Corresponding Applicant - McGill University
Alan Barkun - Collaborator - McGill University
Dominique Hillaire-Buys - Collaborator - Montpellier University Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jean-Luc Faillie - Collaborator - Montpellier University Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General HospitalOutcomes: none known
Description: Technical Summary
The main objective of this study is to evaluate the association between the use of incretin-based drugs and the incidence of bile duct and gallbladder diseases in patients with type 2 diabetes. The United Kingdom Clinical Practice Research Datalink and the Hospital Episodes Statistics database will be used to conduct a cohort study among 75,000 patients initiating antidiabetic drugs between 2007 and 2014. A time-dependent exposure definition will be used, which will compare current use of incretin-based drugs with current use of at least two oral hypoglycaemic agents. Cox proportional hazards models will be used to estimate hazard ratios and 95% confidence intervals of hospitalized bile duct or gallbladder events. All models will be adjusted for relevant potential confounders. This large population-based study will provide much needed information on the safety of incretin-based drugs.
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An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 18-months post launch — David Price ...
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An observational evaluation of prescribing of fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist (ICS/LABA): fluticasone propionate / formoterol (FP/FOR) and adverse events in routine primary care at 18-months post launch
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-08
Organisations:
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Jessica Martin - Corresponding Applicant - Wellcome Trust Sanger Institute
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Frank Andersohn - Collaborator - Frank Andersohn Consulting & Research Services
Karin Maria Thelen - Collaborator - Mundipharma Research Ltd
Vicky Thomas - Collaborator - Cambridge Research Support Ltd.Outcomes: none known
Description: Technical Summary
This study aims to evaluate adverse events, prescribing prevalence and patient characteristics for patients initiating on FP/FOR or other FDC ICS/LABA therapies prescribed in the 18 months post launch of FP/FOR in the UK. It will be a historical cohort study within which four subgroups will be evaluated (adult patients (⥠12 years) with asthma, patients with COPD (and no asthma), paediatric asthma patients 4â11 years, patients prescribed ICS/LABA as the âMARTâ regimen). Patients included have â¥1 prescriptions for any ICS/LABA fixed-dose combination from 2012. The number and percentage of patients prescribed FP/FOR and other FDC ICS/LABAs and the frequency and percentage of adverse events and patient characteristics including demographic characteristics, comorbidities, medication and disease-severity measures will be evaluated for patients prescribed FP/FOR and other FDC ICS/LABA therapies, and for each of the subgroups.
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Validation of the recording of asthma diagnosis in adult patients in the Clinical Practice Research Datalink — Jennifer Quint ...
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Validation of the recording of asthma diagnosis in adult patients in the Clinical Practice Research Datalink
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-31
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Francis Nissen - Corresponding Applicant - Roche
Daniel Morales - Collaborator - University of Dundee
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Neil Pearce - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
The overall aim of this study is to determine the positive predictive value (PPV) of an asthma diagnostic code within the CPRD GOLD, i.e., a proportion of true positives among those assumed to have been diagnosed with asthma. In order to achieve this we will construct a retrospective cohort of asthma patients and compare database information (CPRD GOLD and the Multiple Deprivation Index) with information gathered by a questionnaire filled in by general practitioners and review of any supporting information sent. A review of these questionnaires by two independent expert physicians will be considered as the gold standard to assess the PPV of an asthma recording using specific algorithms in CPRD GOLD.
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Comparison of the risk of cancer outcomes between patients with type 2 diabetes exposed to dapagliflozin and those exposed to other antidiabetic treatments — Lia Gutierrez ...
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Comparison of the risk of cancer outcomes between patients with type 2 diabetes exposed to dapagliflozin and those exposed to other antidiabetic treatments
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-21
Organisations:
Lia Gutierrez - Chief Investigator - RTI Health Solutions
Leah McGrath - Corresponding Applicant - RTI Health Solutions
Alicia Gilsenan - Collaborator - RTI Health Solutions
Brian Calingaert - Collaborator - RTI Health Solutions
Catherine Saltus - Collaborator - RTI Health Solutions
Elizabeth Andrews - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
James Kaye - Collaborator - RTI Health Solutions
Jaume Aguado - Collaborator - RTI Health Solutions
Jennifer Bartsch - Collaborator - RTI Health Solutions
Joan Fortuny - Collaborator - RTI Health Solutions
Karolina Andersson Sundell - Collaborator - Astra Zeneca R&D Molndal Sweden
Kay Johannes - Collaborator - RTI Health Solutions
Lisa McQuay - Collaborator - RTI Health Solutions
Maria Reynolds - Collaborator - RTI Health Solutions
Shannon Hunter - Collaborator - RTI Health Solutions
Sophie Shen - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Zhou Xiaolei - Collaborator - RTI Health SolutionsOutcomes: none known
Description: Technical Summary
This cohort study compares the incidence of female breast cancer and the sex-specific incidence of bladder cancer among new users of dapagliflozin with those among new users of other specific ADs. The study duration is 10 years. Follow-up will start on the date a patient has a first prescription or dispensing for a study drug, and will continue until first occurrence of any cancer end-point, death, discontinuation from the study database, or the end of the study. The study will be implemented in adults in four administrative health care data sources in three countries: United Kingdom: the Clinical Practice Research Datalink; United States: the Centers for Medicare and Medicaid Services Medicare databases and the HealthCore Integrated Research Database; Netherlands: the PHARMO Database Network. Propensity scores will be estimated at cohort entry by logistic regression models. Incidence rates of each outcome will be determined in each cohort. Propensity score stratification will be used to estimate adjusted incidence rate ratios of the outcomes of interest with 95% confidence intervals. Analyses will be conducted in each data source, and a pooled estimate will be calculated if deemed appropriate.
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Association between Diabetes Mellitus and Incident Meniere's Disease — Christoph Meier ...
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Association between Diabetes Mellitus and Incident Meniere's Disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-31
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Saskia Bruderer - Corresponding Applicant - University of Basel
Daniel Bodmer - Collaborator - University of Basel
Nadja Alexandra Stohler - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes: none known
Description: Technical Summary
Meniere's disease (MD) is a disease of the inner ear. There is only limited data on the epidemiology of MD, and the underlying pathology is still poorly understood. There are several hypotheses about the pathophysiology, but only few associations have been explored in rather small study populations. There is only little evidence on the association between diabetes mellitus overall, diabetes severity, diabetes control, diabetes duration and use of antidiabetic treatment in relation to the risk of developing incident MD. Previous studies suggested that patients with MD have a carbohydrate metabolism disorder, and a correlation with advanced hyperinsulinemia has been proposed. Therefore, diabetes itself or its treatment could influence the risk of onset of MD.
We will apply multivariate conditional logistic regression analyses calculating odds ratios (ORs) with 95% confidence intervals (CIs) to explore in a large observational case-control analysis the association between diabetes and use of antidiabetic drugs and their association with the occurrence of MD.
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Congenital malformations and maternal use of anti-hypertensive medication in the UK — Claudia Cabrera ...
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Congenital malformations and maternal use of anti-hypertensive medication in the UK
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-08
Organisations:
Claudia Cabrera - Chief Investigator - Astra Zeneca R&D Molndal Sweden
Claudia Cabrera - Corresponding Applicant - Astra Zeneca R&D Molndal Sweden
Alison Lee - Collaborator - Commonwealth Informatics
Cecilia Falkenberg - Collaborator - Astra Zeneca Inc - USA
Karin Henriksson - Collaborator - Astra Zeneca Inc - USA
Michael Goodman - Collaborator - Astra Zeneca Inc - USAOutcomes: none known
Description: Technical Summary
Research is needed to assess the use of antihypertensive medication among adult females of child bearing age, under real world circumstances. Earlier studies have been unable to stratify anti-hypertensive medications sufficiently to truly assess foetal outcomes and health risks per drug class, Angiotensin II Receptor Antagonists/Blockers (ARBs) and Angiotensin-converting-enzyme inhibitor (ACE inhibitor) in particular. We will attempt to describe the prescription rate of ARBs and ACE inhibitors among women with very high blood pressure, plus other co-morbid conditions, in the United Kingdom (UK) and estimate the risk of serious foetal outcomes among live births.
The main objective of this study is to evaluate serious adverse fetal outcomes (diagnoses of congenital malformation in live births or post-partum infant death) in women treated with anti-hypertensive medication, more specifically, Angiotensin II Receptor Antagonists/Blockers (ARBs) and Angiotensin-converting-enzyme inhibitors (ACE inhibitors). Women who are hypertensive and pregnant will be included in the study the study period start will be from January 1, 1997 until December 31, 2014.
Where possible, each mother will be linked to data records relating to their newborn to allow analysis of adverse fetal outcomes. These outcomes will be obtained from the following sources, UK primary care data (CPRD GOLD), inpatient hospital episode statistics (HES) and Office of National Statistics (ONS) mortality data, to attempt to build a full picture of what may occur to a child when exposed to anti-hypertensive medication while in the womb. However, not all data sources will contain information on every baby identified in the cohort therefore we may have to tailor the analyses based on complete cohort size.
Although the overarching goal is to look at the impact of anti-hypertensive medication during pregnancy, other factors relating to the mothers health and circumstances such as, pre-existing diabetes or heart failure, weight and age at pregnancy start, smoking, and socio-economic status, will also be analysed in order to better understand the mother's risk profile impacting adverse fetal outcomes.
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Quality and completeness of recording of social factors related to vaccine uptake in linked electronic health records — Sara Thomas ...
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Quality and completeness of recording of social factors related to vaccine uptake in linked electronic health records
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-30
Organisations:
Sara Thomas - Chief Investigator - Not from an Organisation
Anu Jain - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Albert J. van Hoek - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Jemma Walker - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rohini Mathur - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
Addressing inequalities in vaccine uptake to prevent infections in both children and adults is a key priority for public health. In England, current surveillance methods provide little information about social factors associated with the burden of vaccine-preventable diseases or vaccine uptake. These social factors may vary for older individuals and children. The aims of this study are to investigate if linked electronic health records (EHR) could contribute towards ascertainment of these social factors.
A detailed investigation of social factors that are potentially available for analyses for children (â¤5 years) and older individuals (â¥65 years) in linked Clinical Practice Research Datalink (CPRD) data from England will be undertaken. Code lists for social factors of interest will compiled from the different data files. Each social factor will be examined for: completeness of data, timeliness of recording for factors that might change over time, representativeness of recorded data (by comparing these data with English census data) and the extent to which completeness is improved by using linked EHR.
This project will provide information about the utility of CPRD in ascertainment of social factors for vaccine-preventable disease burden and vaccine uptake analyses, to supplement/enhance existing surveillance methods and help to address vaccine-related health inequities.
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Patterns of prescribing in end of life care using CPRD data. — Rupert Payne ...
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Patterns of prescribing in end of life care using CPRD data.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-08
Organisations:
Rupert Payne - Chief Investigator - University of Bristol
Amelia Harshfield - Corresponding Applicant - University of Cambridge
Kirsty Rhodes - Collaborator - University of Cambridge
Stephen Barclay - Collaborator - University of CambridgeOutcomes: none known
Description: Technical Summary
Polypharmacy, driven by an ageing, multimorbid population and a culture of single-condition guideline-driven prescribing, is becoming increasingly widespread in primary care. The evidence base for many medications is lacking in older, frail and multimorbid populations; benefits may be particularly questionable as the end of life approaches, especially where the intended gain from treatments may only be realised over several years. Little is known about patterns of polypharmacy and palliative medication towards the end of life in the general practice setting, and understanding these issues is central to developing and targeting medication optimisation strategies relevant to patients towards the end of life.
A retrospective cohort analysis will be conducted for all patients that died in 2009-2014. Prescribing data during the final 12 months of life will be studied. Descriptive analyses of temporal trends in polypharmacy and drug classes specific to symptom management (e.g. opioids) will be carried out, including modelling the association of prescribing change with cause of death.
This work will be a very important contribution to the literature on end-of-life care. It will generate an understanding of factors influencing prescribing towards the end of life, and improve the identification of individuals subject to suboptimal prescribing.
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Cost Effectiveness of Different Patterns of Monitoring of Cardiovascular Medications in General Practices — Tony Avery ...
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Cost Effectiveness of Different Patterns of Monitoring of Cardiovascular Medications in General Practices
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-08
Organisations:
Tony Avery - Chief Investigator - University of Nottingham
Vladislav Berdunov - Corresponding Applicant - University of Nottingham
Li-Chia Chen - Collaborator - University of Manchester
Rachel Elliott - Collaborator - University of ManchesterOutcomes: none known
Description: Technical Summary
Medication monitoring may improve the safety profile of certain cardiovascular medications, such as angiotensin-converting enzyme inhibitors (ACEI), loop diuretics and amiodarone. There is limited evidence of the effect of missed regular monitoring on the probability of occurrence of adverse drug events (ADEs), cost of treatment and patient quality-of-life in the medication safety literature. This study aims to estimate the cost-effectiveness of alternative strategies involving monitoring long-term therapy of ACEI, loop diuretics and amiodarone at different frequencies. This will be achieved using decision-analytic models built using the results of a previously conducted cohort study which combined the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) with evidence from literature. The main outcome of the analysis is mean cost per patient from the perspective of the NHS per quality-adjusted life-year (QALY) gained during the first 5 years of medication therapy. Both a deterministic analysis will be employed in order to rank different frequencies of monitoring in terms of incremental cost per QALY and a probabilistic sensitivity analysis in order to gauge the effect of uncertainty in the values of model parameters. The results of the analysis will inform evidence-based guidelines for regular monitoring in UK primary care.
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Trends and factors associated with therapy decisions in newly diagnosed COPD patients in GOLD groups A and B.
A non-interventional study using the Clinical Practice Research Datalink (CPRD) database — Anna Scowcroft ...
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Trends and factors associated with therapy decisions in newly diagnosed COPD patients in GOLD groups A and B. A non-interventional study using the Clinical Practice Research Datalink (CPRD) database
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-14
Organisations:
Anna Scowcroft - Chief Investigator - UCB Pharma Ltd
Andrew Ternouth - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Nick Ramscar - Collaborator - Boehringer-Ingelheim Pharmaceuticals, IncOutcomes: none known
Description: Technical Summary
This study is a non-interventional cohort study using existing data (CPRD), to evaluate the factors associated with therapy decisions in newly diagnosed COPD patients in GOLD (Global Initiative for Chronic Obstructive Lung Disease1) groups A and B. The GOLD stages of airflow obstruction and dyspnea are widely used to quantify COPD severity into four categories, A (mild), B (moderate) C (severe) and D (very severe). Severity is determined by combining data from response to the MRC dyspnea questionnaire, the number of exacerbations in the past 12 months, and the FEV1 score (as a % of predicted).
The main objective is to assess which patient or practice characteristics influence the initial choice of ICS therapy combinations over non ICS therapy combinations at initial diagnosis of mild/moderate COPD.
The results from this study will be used to support the scientific understanding of how COPD patients in GOLD groups A and B are treated, and which patients are more likely to be inappropriately treated with ICS.
Comorbidities and demographic information will be described for the groups of patients initiated on different therapy combinations. Logistic regression will be used to investigate the factors which affect whether a GOLD A/B COPD patient is treated with an ICS containing therapy combination when diagnosed with COPD or a non-ICS therapy.
We will also investigate the differences in patient and practice characteristics between GOLD A and B patients prescribed different therapy combinations at initial COPD diagnosis, and examine the trend in prescribing of COPD therapies to patients in GOLD groups A and B at initial COPD diagnosis over the last 10 years.
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Descriptive study of patients with haemophilia in the CPRD. — Susan Jick ...
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Descriptive study of patients with haemophilia in the CPRD.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-18
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Judith Kempf - Collaborator - Genzyme - Sanofi Company
Marianne Ulcickas Yood - Collaborator - EpisourceOutcomes: none known
Description: Technical Summary
We will identify all patients with a Read code for haemophilia A or B and will conduct a validation study of the diagnoses. We will request clinical records for a random sample of all haemophilia A and B patients from GPs, where available, to validate the diagnosis and to collect information on treatments and details of the disease course not available in the computer record. Haemophilia is an unambiguous disease with clear diagnostic criteria based on simple lab tests, thus we will accept the opinion of the consultant if it states in the record that the patient has the disease. We will also review the complete computer record of each patient to identify disease codes, symptoms, and treatments as additional validation. This will be the only validation for patients for whom we do not receive clinical records. We will provide the results of the validation study as a proportion of validated cases/total cases reviewed. We will also provide descriptive statistics for these haemophilia patients which will include distribution of disease by age, sex, year of diagnosis, comorbidities and treatments both before and after disease diagnosis. We will also calculate annual prevalence of haemophilia A and B as the number of cases of haemophilia alive in each year divided by the number of people alive in the CPRD population in each year.
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Prescribing of antidepressants and adverse outcomes in patients with chronic kidney disease — Dorothea Nitsch ...
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Prescribing of antidepressants and adverse outcomes in patients with chronic kidney disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-29
Organisations:
Dorothea Nitsch - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Masao Iwagami - Corresponding Applicant - University of Tsukuba
Helen McDonald - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kathryn Mansfield - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
Objectives are to examine (i) prevalence, incidence, and prescribing patterns of antidepressants for patients with chronic kidney disease (CKD), as compared with those without CKD; (ii) which antidepressant is associated with increased risk of each outcome according to patientsâ kidney function. For objective (i), we will conduct a descriptive cohort study. Using the data in CPRD linked to Inpatient Hospital Episode Statistics, we will make a cohort of patients with CKD, based on serum creatinine records, and a comparison cohort of patients without CKD, matched for age, sex and GP. We will compare prevalence, incidence, patterns (type, indication, and concurrent prescription of psychoactive drugs) of antidepressant prescription between patients with and without CKD, and among patients in different CKD stage, adjusting for background factors. For objectives (ii), we will use a new user cohort design, where we identify patients newly starting antidepressants and stratify them according to their most recent kidney function. We will compare different classes of antidepressants, as well as different antidepressants in the same class, for the incidence rates of major outcomes (sudden death, myocardial infarction, stroke, fracture due to fall, and gastrointestinal bleeding) among patients with the same level of kidney function. We will conduct multivariable Poisson regression analyses to adjust for confounding factors, with additional propensity-score matching method and taking into account changes in CKD stage over time.
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Descriptive study of patients in the CPRD with lysosomal function disorders. — Susan Jick ...
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Descriptive study of patients in the CPRD with lysosomal function disorders.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-02
Organisations:
Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Judith Kempf - Collaborator - Genzyme - Sanofi Company
Marianne Ulcickas Yood - Collaborator - EpisourceOutcomes: none known
Description: Technical Summary
We will identify all patients with a Read code for each of the 5 study diseases (Fabry, Gaucher, mucopolysaccharidosis 1 (MPS I), also known as Hurler's syndrome, Pompe, and Niemann-Pick), and will conduct a validation study of all diagnosed patients. We will request hospital and consultant letters, as well as GP notes, where available from GPs to validate the diagnosis and to collect information on treatments and details of the disease course not available in the computer record. We will also review the complete computer record of each patient to identify disease codes, symptoms, and treatments as additional validation. This will be the only validation for patients for whom we do not receive clinical records. We will provide descriptive statistics for each of the 5 diseases which will include distribution of disease by age, sex, year of diagnosis, comorbidities and treatments. We will also calculate incidence rates as the number of cases over person time in the CPRD population.
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Comparison of the risk of acute outcomes between patients with type 2 diabetes exposed to dapagliflozin and those exposed to other antidiabetic treatments — Kay Johannes ...
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Comparison of the risk of acute outcomes between patients with type 2 diabetes exposed to dapagliflozin and those exposed to other antidiabetic treatments
Datasets:GP data, HES Admitted Patient Care; HES Admitted Patient Care; HES Outpatient; HES Outpatient; ONS Death Registration Data; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-21
Organisations:
Kay Johannes - Chief Investigator - RTI Health Solutions
Leah McGrath - Corresponding Applicant - RTI Health Solutions
Alejandro Arana Navarro - Collaborator - RTI Health Solutions
Alicia Gilsenan - Collaborator - RTI Health Solutions
Brian Calingaert - Collaborator - RTI Health Solutions
David Martinez - Collaborator - RTI Health Solutions
Elizabeth Andrews - Collaborator - RTI Health Solutions
Estel Plana Hortoneda - Collaborator - RTI Health Solutions
Heather Danysh - Collaborator - RTI Health Solutions
J. Bradley Layton - Collaborator - RTI Health Solutions
Jaume Aguado - Collaborator - RTI Health Solutions
Jennifer Bartsch - Collaborator - RTI Health Solutions
Joan Fortuny - Collaborator - RTI Health Solutions
Jordi Castellsague - Collaborator - RTI Health Solutions
Karolina Andersson Sundell - Collaborator - Astra Zeneca R&D Molndal Sweden
Lia Gutierrez - Collaborator - RTI Health Solutions
Lisa McQuay - Collaborator - RTI Health Solutions
MANEL PLADEVALL - Collaborator - RTI Health Solutions
Maria Reynolds - Collaborator - RTI Health Solutions
Ryan Ziemiecki - Collaborator - RTI Health Solutions
Shannon Hunter - Collaborator - RTI Health Solutions
Sophie Shen - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Zhou Xiaolei - Collaborator - RTI Health SolutionsOutcomes: none known
Description: Technical Summary
This cohort study compares the incidences of hospitalization for AKI, hospitalization for ALI, and sex-specific incidence of severe complications of UTI among new users of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor medication, with those among new users of other specific ADs. The study duration is 5 years. Follow-up will start on the date a patient has a first prescription recorded in CPRD or dispensing recorded in the other data sources for a study drug, and will continue until first occurrence of any acute end-point, death, discontinuation from the study database, or the end of the study. The study will be implemented in adults in three administrative health care data sources in two countries: United Kingdom: the Clinical Practice Research Datalink; and the United States: the Centers for Medicare and Medicaid Services Medicare databases and the HealthCore Integrated Research Database. Propensity scores will be estimated at cohort entry by logistic regression models. Incidence rates of each outcome will be determined in each cohort. Propensity score stratification will be used to estimate adjusted incidence rate ratios comparing dapagliflozin with comparator ADs for each outcome of interest with 95% confidence intervals. Analyses will be conducted in each data source, and a pooled estimate will be calculated using aggregate data, if deemed appropriate.
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Incidence and Prevalence of the Parkinson's Disease in the United Kingdom during 1987-2014 — Amy Morrison ...
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Incidence and Prevalence of the Parkinson's Disease in the United Kingdom during 1987-2014
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-23
Organisations:
Amy Morrison - Chief Investigator - Parkinson's UK
Amy Morrison - Collaborator - Parkinson's UKOutcomes: none known
Description: Technical Summary
The overall objective to update current estimates for UK incidence and prevalence of Parkinson's disease using the most current available data in the CPRD. The updated estimates will include stratification into relevant administrative and health geographies as well as relevant age-sex distributions.
This study will attempt to identify all available cases of Parkinson's disease from 1987 through the end of 2014 using a convenience sample of patient information submitted to the CPRD from participating General Practice facilities throughout the UK. Cases will be identified using GP Read Codes queried from the medical record. The overall annual number of patients registered in the CPRD will also be included and used as a denominator for incidence and prevalence calculations.
All statistical analyses will be conducted using SPSS v23. Where appropriate, summary tables will be provided using standard descriptive statistics for both continuous and categorical variables. Age-sex pyramids will be produced to show the overall age-sex distributions of both cases and annual CPRD counts.
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Statin Potency and the Risk of Hospitalization for Community-Acquired Pneumonia — Samy Suissa ...
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Statin Potency and the Risk of Hospitalization for Community-Acquired Pneumonia
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-12-03
Organisations:
Samy Suissa - Chief Investigator - McGill University
Kristian Filion - Corresponding Applicant - McGill University
Ju-Young Shin - Collaborator - McGill University
Maria Eberg - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill UniversityOutcomes: none known
Description: Technical Summary
With emphasize on more aggressive lipid-lowering therapy, there is a need for an assessment of the potential benefits and harms of higher potency statins relative to lower potency statins. This study is to compare the rate of incident hospitalization for community-acquired pneumonia (HCAP) among patients prescribed higher potency statins to that of patients prescribed lower potency statins. We will conduct a nested case-control analysis of a retrospective population-based cohort using data extracted from the United Kingdomâs Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) between April 1st, 1998 and October 31st, 2011. From our cohort of new users of statins, cases will be defined as the HCAP using a previous validated diagnosis, and 10 controls will be matched up to each case on duration of follow-up, cohort entry date, age, and sex. Exposure to lower or higher potency statins will be measured and compared between cases and controls. We will use conditional logistic regression to estimate odds ratios and corresponding 95% confidence intervals.
Source
2015 - 11
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Is gout a risk factor for erectile dysfunction? — Edward Roddy ...
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Is gout a risk factor for erectile dysfunction?
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-16
Organisations:
Edward Roddy - Chief Investigator - Not from an Organisation
Christian Mallen - Collaborator - Keele University
Rebecca Whittle - Collaborator - Keele University
Richard Hayward - Collaborator - Keele University
Sara Muller - Collaborator - Keele UniversityOutcomes: none known
Description: Technical Summary
The objective of this study is to determine whether there is a potentially causal association between the diagnosis of gout and the subsequent development of erectile dysfunction. The study design is a matched cohort study. Men with a new diagnosis of gout will be matched (1:4) on year of birth and general practice to men without gout up to the date of their matched gout patient's diagnosis. Patients with and without gout will also be free of a diagnosis of erectile dysfunction and not prescribed medication for this condition prior to this date. The outcome of interest will be a diagnosis of incident erectile dysfunction. A feasibility count in CPRD suggests that there are 49,462 men with an incident diagnosis of gout and no pre-existing diagnosis of or treatment for erectile dysfunction from 01/01/1990 to 31/12/2010. Assuming that 8% of men without gout consult for erectile dysfunction over a 10-year period, this sample size provides 98% power detect a hazard ratio of 1.2. Cox regression models will be used to assess the association between gout status (exposure) and time to diagnosis of erectile dysfunction, adjusted for confounding comorbid conditions and prescriptions.
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Effects of selective serotonin reuptake inhibitors on the risk of mortality in patients with epilepsy: a CALIBER study using linked data — Colin Josephson ...
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Effects of selective serotonin reuptake inhibitors on the risk of mortality in patients with epilepsy: a CALIBER study using linked data
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-19
Organisations:
Colin Josephson - Chief Investigator - O'Brien Institute for Public Health & Hotchkiss Brain Institute
Colin Josephson - Corresponding Applicant - O'Brien Institute for Public Health & Hotchkiss Brain Institute
Alireza Moayyeri - Collaborator - UCB Pharma SA - UK
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
The objective of this study determine whether selective serotonin reuptake inhibitors (SSRI) use is associated with decreased mortality in patients with epilepsy.
Data will be extracted from the CALIBER database that links electronic medical records and administrative data from the Clinical Practice Research Datalink, Hospital Episode Statistics, the Myocardial Ischaemia National Audit Project, and the Office of National Statistics. We will extract an epilepsy cohort using a previously validated case definition. Data will then be provided to the analyst by the CALIBER data manager in a secure network in text files that can be directly uploaded to the statistical packages for further analysis.
We will approach the problem using two different analysis plans. First, we will use Cox proportional survival analysis to follow patients forward from the point of SSRI prescription to last follow-up or death. The hazard of death will be compared between those receiving SSRIs to those who are not. Second, we will perform an analysis using by identifying all patients with epilepsy and comparing them to a control group without epilepsy. We will evaluate those who died of sudden death in each group and compare SSRI use in between populations over the final 6 months.
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Comparison of the performance of the English NHS Health Checks & Scottish Keep Well programmes — Michael Soljak ...
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Comparison of the performance of the English NHS Health Checks & Scottish Keep Well programmes
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-26
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Assem Kurzhangulova - Collaborator - Imperial College London
Colin Fischbacher - Collaborator - University of Edinburgh
Kiara Chang - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
The main objective is to compare the English NHS Health Check programme and the Scottish Keep Well programme in terms of their coverage in the eligible population, global CVD risk and risk factor prevalence, and statin prescribing. We will quantify the population eligible for a health check from individuals aged 40-74 between 1 April 2009 and 31 March 2013 for the English programme, and from individuals aged 45-64 years between 1 April 2006 and 31 March 2013 for the Scottish population.
We will calculate and assess equities in coverage using a multilevel logistic regression model and compare them between the two countries using chi-square tests, or by including an interaction term into the regression model (aim 1). Level of population global CVD risk and individual risk factors will be summarized in means or proportions, and compared between the English and Scottish populations using t-tests or chi-square tests (aim 2). Level of statins prescribing will be assessed and compared between two populations using chi-square tests. Statistical analyses will be carried out using StataSE 13 software.
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A descriptive study of LAIV utilization to identify and characterize medication errors due to expired vaccine use in individuals 2-17 years of age in the CPRD — Robert (Bob) Steven Brody ...
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A descriptive study of LAIV utilization to identify and characterize medication errors due to expired vaccine use in individuals 2-17 years of age in the CPRD
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-30
Organisations:
Robert (Bob) Steven Brody - Chief Investigator - Astra Zeneca Inc - USA
Herve Caspard - Corresponding Applicant - MedImmune
Amy Steffey - Collaborator - Not from an Organisation
Robert Wise - Collaborator - MedImmuneOutcomes: none known
Description: Technical Summary
The purpose of this study is to estimate the proportion of LAIV administrations that used expired product among children aged 2-17 years during the two most recent influenza seasons and to identify risk factors. In addition, the study will document the distribution of the number of days between expiration and vaccination date.
Administration of expired LAIV will be identified by comparison of the vaccination date in the CPRD record with the corresponding lot expiration date from records maintained by the vaccine manufacturer. The proportion of individuals receiving expired vaccine and 95% CIs among all LAIV recipients will be calculated according to subject characteristics (age, gender, comorbidities, region, length of registration at the practice), physician practice characteristics (practice size, Health Service Area) and calendar time. Predictors of administration of expired doses will be assessed by a multivariate regression to take into account potential confounders. Median intervals and measures of dispersion of the number of days between vaccination and vaccine expiration dates will also be described.
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The association between statin prescribing and the risk of glioma: a matched case-control study — Christoph Meier ...
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The association between statin prescribing and the risk of glioma: a matched case-control study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-30
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Collaborator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Michael Leitzmann - Collaborator - University of Regensburg
Peter Hau - Collaborator - University of Regensburg
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Ulrich Bogdahn - Collaborator - University of RegensburgOutcomes: none known
Description: Technical Summary
Using data from the CPRD, we intend to perform a 1:10 matched cases control analysis to explore the association between statin use and risk of glioma. Relative risks will be estimated by conducting conditional logistic regression analyses to determine odds ratios (ORs) with 95% confidence intervals (CIs) of glioma in relation to use of statins. Analyses will be adjusted for various potential confounders and only factors altering the risk of glioma by >10% will be included in the final multivariate analysis.
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Stress Urinary Incontinence and Suicidality Seen in the Clinical Practice Research Datalink (CPRD) — Hu Li ...
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Stress Urinary Incontinence and Suicidality Seen in the Clinical Practice Research Datalink (CPRD)
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-04
Organisations:
Hu Li - Chief Investigator - Eli Lilly & Co - UK
Dustin Ruff - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Jonathan Swain - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Mark Bangs - Collaborator - Eli Lilly & Co Ltd - US HeadquartersOutcomes: none known
Description: Technical Summary
Stress urinary incontinence (SUI) is the involuntary leakage of urine on effort or exertion or on sneezing or coughing, the most common type of urinary incontinence reported by women. To date, no background suicidality rates specifically in stress incontinent women are available in the published literature. The proposed study is to evaluate the rates of suicidality for the SUI diagnosed women either treated with duloxetine or not receiving duloxetine. Rates of suicidality will also be estimated for SUI women and a comparable sample of women without urinary incontinence (UI) seen in the same general practitioner's offices.
All analyses will be performed accounting for demographics and clustering by medical practice. Covariates of interest are known predictors of suicidality, such as a diagnosis of depression, past history of non-fatal suicide attempts, a diagnosis of other psychiatric conditions, history of psychiatric hospitalizations, use of antidepressants as documented in the available medical records (pertinent Read or OXMIS Medical Codes specified in the Appendix), and the presence of comorbid serious conditions, if warranted. The proposed study is a repeated analysis, and the previous protocol (# 10_185) was approved on 18th January 2011.
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Risk of MI associated with acute exacerbations of chronic obstructive pulmonary disease (COPD): a self-controlled case series — Jennifer Quint ...
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Risk of MI associated with acute exacerbations of chronic obstructive pulmonary disease (COPD): a self-controlled case series
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-20
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Kieran Rothnie - Corresponding Applicant - GlaxoSmithKline - UK
Hana Mullerova - Collaborator - Astra Zeneca Ltd - UK Headquarters
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Neil Pearce - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
We will use CPRD linked with HES and ONS to conduct a self-controlled case series to investigate the risk of myocardial infarction (MI) in people with COPD during and shortly after periods of exacerbation compared to stable periods. The self controlled case series method allows the effects of transient exposures on events to be investigated. A major advantage of this method is that fixed confounders are controlled for implicitly. The research team have extensive experience in using this method to investigate the effects of transient vascular risk factors, including the effect of lower respiratory tract infections on risk of MI. We will investigate whether there is an increased risk of MI associated with acute exacerbations of COPD (AECOPD) and investigate the length of the period of potential increased risk. We will also investigate whether severity of AECOPD, concurrent use of cardiovascular drugs, non-MI previous cardiovascular disease, and exacerbator phenotype modifies any risk of MI associated with AECOPD. The findings from this study will be used by clinicians to understand when their COPD patients may be at highest risk of MI and may inform future interventions to reduce this risk.
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Near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD) â a feasibility study — Sara Thomas ...
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Near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD) â a feasibility study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-26
Organisations:
Sara Thomas - Chief Investigator - Not from an Organisation
Andreia Leite - Corresponding Applicant - London School of Hygiene & Tropical Medicine ( LSHTM )
Nick Andrews - Collaborator - Public Health England
Philip Bryan - Collaborator - MHRA
Stephen Evans - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
This study comprises a two-stage feasibility assessment of implementing near real-time vaccine safety surveillance (NRTVSS) methods using CPRD. The first stage will include assessments of validity, volume of data, and data accrual for selected outcomes of interest in CPRD (potential adverse events). To study validity, previous validation studies for the outcomes of interest in CPRD will be considered. For volume of data assessment, power calculations for different sequential tests will be performed, considering the incidence and risk window for the outcome. Analyses to describe the data accrual process will include comparisons of the date of recorded diagnosis in CPRD and Hospital Episode Statistics, and looking at last practice collection dates. This first assessment will enable classification of outcomes as potentially feasible or non-feasible (poor validity, insufficient power or unacceptably delayed recording). For outcomes deemed potentially feasible a more detailed feasibility assessment, mimicking a near-real time system, will compare different statistical tests, appropriate control for confounding strategies, and methods to adjust for data accrual lags. A special focus will be on group sequential methods. Existing methods will be adapted to ensure best use in CPRD. For outcomes considered currently non-feasible, changes needed to enable feasibility will be discussed.
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The role of systemic inflammatory diseases in long-term morbidity and mortality: a retrospective, matched-cohort study in the Clinical Practice Research Datalink — Lorna Clarson ...
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The role of systemic inflammatory diseases in long-term morbidity and mortality: a retrospective, matched-cohort study in the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-17
Organisations:
Lorna Clarson - Chief Investigator - Not from an Organisation
Lorna Clarson - Corresponding Applicant - Not from an Organisation
Alyshah Abdul Sultan - Collaborator - Astra Zeneca Ltd - UK Headquarters
Christian Mallen - Collaborator - Keele University
John Belcher - Collaborator - Keele University
Rebecca Whittle - Collaborator - Keele UniversityOutcomes: none known
Description: Technical Summary
Background: Systemic inflammatory conditions such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis are known to be associated with increased risk of a variety of adverse health events, such as cardiovascular disease, strokes, cancer and death. Observational studies examining outcomes in patients with inflammatory conditions are limited, and comparison of the risks between diseases has not been possible.
Primary aim: To estimate the relative effect of systemic inflammatory conditions on the risk of serious adverse health outcomes such as myocardial infarction (MI), venous thromboembolism (VTE), cancer, infection or death.Methods: A retrospective matched cohort study utilizing data from Clinical Practice Research Datalink (CPRD). Exposed individuals will be those with diagnoses of systemic inflammatory diseases (SID) from 1998-2003. Incidence rates of outcomes of interest will be calculated and compared in each disease group.
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Utilization of Standard and Target-Specific Oral Anticoagulants among Adults in the United Kingdom with Incident Non-Valvular Atrial Fibrillation — Morris Weinberger ...
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Utilization of Standard and Target-Specific Oral Anticoagulants among Adults in the United Kingdom with Incident Non-Valvular Atrial Fibrillation
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-24
Organisations:
Morris Weinberger - Chief Investigator - University of North Carolina at Chapel Hill
Todd Durham - Corresponding Applicant - IQVIA - USA (Headquarters)
Anthony Viera - Collaborator - University of North Carolina at Chapel Hill
Jason Fine - Collaborator - University of North Carolina at Chapel Hill
Jayanti Mukherjee - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Kristen Hasmiller Lich - Collaborator - University of North Carolina at Chapel Hill
Stacie Dusetzina - Collaborator - University of North Carolina at Chapel HillOutcomes: none known
Description: Technical Summary
Two recent developments in atrial fibrillation (AF) â new therapeutic options and updated risk stratification â have the potential to improve the quality of care of patients with AF. The objectives of this study are to describe the time from AF diagnosis to oral anticoagulant (OAC) initiation, examine the patient characteristics associated with treatment choice, and describe the timing and cumulative incidence of switching OACs. To address these objectives we will identify a cohort of patients with incident AF between 2010 and 2014 who were potential candidates for a target-specific OAC. The dependent variables include the time from diagnosis to OAC initiation, the first selected treatment within the first 90 days of diagnosis, and the time from first OAC initiation to switch to a different OAC. Independent variables include factors associated with increased risk of stroke, factors associated with increased risk of bleeding, and other potential contraindications. The time from diagnosis to OAC initiation and time from OAC to OAC switch will be analyzed using the Kaplan-Meier estimator. Associations between the selected treatment and each of the independent variables will be evaluated using logistic regression.
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Evaluation of Potential Cardiovascular, Respiratory and Metabolic Effects of Long-term Use of Proton-Pump Inhibitor Therapy in Older Patients — David Melzer ...
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Evaluation of Potential Cardiovascular, Respiratory and Metabolic Effects of Long-term Use of Proton-Pump Inhibitor Therapy in Older Patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-05
Organisations:
David Melzer - Chief Investigator - University of Exeter
Jan Zirk-Sadowski - Corresponding Applicant - University of Exeter
Alessandro Ble - Collaborator - University of Exeter
Jane Masoli - Collaborator - University of Exeter
Joao Delgado - Collaborator - University of Exeter
Peter Hughes - Collaborator - University of Exeter
Ruben Mujica Mota - Collaborator - University of Exeter
William David Strain - Collaborator - University of Exeter
William Hamilton - Collaborator - University of Exeter
William Henley - Collaborator - University of ExeterOutcomes: none known
Description: Technical Summary
The primary objective is to evaluate the risk of incident cardiovascular events (myocardial infarction, MI), as well as that of community acquired pneumonia and fragility fractures in patients aged 60 and over exposed to PPIs for long periods of time. We aim to understand whether age and burden of disease increase the risk of these potential adverse reactions and costs associated with PPI use. To do this, a retrospective parallel cohorts study will be constructed to understand risks in older patients. PPIs (class) receipt will be the exposure and MI, pneumonia and fragility fractures the primary endpoints. Main hypotheses will be tested using Cox regressions including age, burden of disease as potential effect modifiers, and other available covariates in the Cox models to obtain maximally truthful estimates; known confounding will be addressed with regression adjustment by covariates and by propensity scoring, and unknown confounding by the Prior Event Rate Ratio approach. Costs will be derived by extracting health-care utilisation measures from CPRD and Healthcare Resource Group categories from Hospital Episode Statistics. This work is funded by NIHR Research for Patient Benefit (PB-PG-0214-33099), and is closely linked to the NIHR School for Public Health Research âAgeing Wellâ programme work in Exeter on risks and benefit of cardiovascular prevention strategies in the elderly.
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Descriptive Characteristics of the Clinical Practice Research Datalink (CPRD) EMIS database. — Jennifer Campbell ...
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Descriptive Characteristics of the Clinical Practice Research Datalink (CPRD) EMIS database.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-04
Organisations:
Jennifer Campbell - Chief Investigator - CPRD
Daniel Dedman - Collaborator - CPRD
Wilhelmine Meeraus - Collaborator - GlaxoSmithKline - UKOutcomes: none known
Description: Technical Summary
The Clinical Practice Research Datalink (CPRD) has recently begun collecting primary care data from practices using the EMIS software system. The aim of this study is to characterise these data in terms of population, practice and patient characteristics and key clinical parameters. We will use data available in the Patient and other relevant clinical data tables to calculate simple descriptive statistics such as mortality rates. Results will be compared to previously published work characterising the CPRD Vision database and statistics from the 2011 UK census data. This work is intended to be published in a peer reviewed journal to provide a reference point for future studies using the CPRD EMIS data.
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Association between Use of Beta-blockers or Diuretics and Incident Meniere's Disease — Christoph Meier ...
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Association between Use of Beta-blockers or Diuretics and Incident Meniere's Disease
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-30
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Saskia Bruderer - Corresponding Applicant - University of Basel
Daniel Bodmer - Collaborator - University of Basel
Nadja Alexandra Stohler - Collaborator - University of Basel
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes: none known
Description: Technical Summary
MD is a disease of the inner ear. There is only limited data on the epidemiology of MD and on the underlying pathology which is still poorly understood.
Possible causes of MD may be aberrant fluid homeostasis resulting in a high pressure and endolymphatic hydrops or in reduced perfusion of the inner ear. Beta-blockers and diuretics are both used to reduce blood pressure and therefore may influence blood flow. To our knowledge no previous studies have explored the association between use of beta-blockers or diuretics and the risk of incident MD.
In this large observational case-control analysis we plan to explore the association between use of beta-blockers and diuretics and the occurrence of MD using conditional logistic regression analyses to calculate odds ratios (ORs) with 95% confidence intervals (CIs).
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Prescribing Trends of ADHD Medications in UK Primary Care — Samy Suissa ...
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Prescribing Trends of ADHD Medications in UK Primary Care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-27
Organisations:
Samy Suissa - Chief Investigator - McGill University
Christel Renoux - Collaborator - McGill University
Ju-Young Shin - Collaborator - McGill University
Sophie Dell'Aniello - Collaborator - McGill UniversityOutcomes: none known
Description: Technical Summary
This study aims to describe time trends of prescribing of ADHD medications over 1995-2015 for children and adults in the UK primary care. We will conduct a longitudinal study using data extracted from the United Kingdom's Clinical Practice Research Datalink (CPRD). Cohort will be defined as all patients between 6 and 45 years of age between 1 January 1995 and 30 September 2015. ADHD drugs will include methylphenidate, dexamphetamine (and lisdexamphetamine), and atomoxetine. The number of ADHD prescriptions will be calculated for each calendar year for each individual based on defined five age categories. Prescription rates will be estimated by dividing the total number of prescriptions in each calendar year by the total number of person-years at risk. We will calculate annual prescription rates and their corresponding 95% confidence intervals (CIs) using Poisson regression, and annual rates will be stratified by sex, age groups, and different ADHD drugs. Average annual change will be estimated by including calendar time as a linear predictor in the Poisson model.
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Using pharmacoepidemiology to test medications associated with altered breast cancer risk identified from connectivity mapping — Chris Cardwell ...
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Using pharmacoepidemiology to test medications associated with altered breast cancer risk identified from connectivity mapping
Datasets:GP data, NCRAS Cancer Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-19
Organisations:
Chris Cardwell - Chief Investigator - Queen's University Belfast
Fabio Liberante - Collaborator - Queen's University Belfast
Gayathri Thillaiyampalam - Collaborator - Queen's University Belfast
Ken Mills - Collaborator - Queen's University Belfast
Liam Murray - Collaborator - Queen's University Belfast
Shu-Dong Zhang - Collaborator - Queen's University BelfastOutcomes: none known
Description: Technical Summary
Background: Connectivity mapping is a novel bioinformatics technique which links gene expression data with expression events induced by a wide range of compounds, including medications. It therefore allows medications to be screened to assess carcinogenicity and anti-cancer properties. This connectivity map process has been implemented to identify 10 prescription medications (used for non-cancer purposes) that may alter breast cancer risk.
Aims: To determine the association between the 10 identified medications (from connectivity mapping) and breast cancer risk.
Methods: A nested case-control study will be conducted. Breast cancer patients (identified from cancer registries) will be matched to five controls on age, calendar year and GP practice. Prescriptions for candidate medications will be determined prior to breast cancer diagnosis or index date in cases and controls, respectively. Conditional logistic regression will be used to calculate odds ratios (ORs), and 95% confidence intervals (95%CIs), for breast cancer in candidate medication users compared with non-users and adjust for potential confounders.
Potential: The study could identify a medication (from connectivity mapping) which increase the risk of breast cancer development; current licensing and use of such medications may need to be reconsidered. This study also could identify licensed medications that reduce breast cancer risk and warrant further study.
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The prescribing of codeine for the treatment of pain in children: A descriptive study — Katherine Donegan ...
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The prescribing of codeine for the treatment of pain in children: A descriptive study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-11-17
Organisations:
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRAOutcomes: none known
Description: Technical Summary
Codeine is an opium alkaloid converted in the body into morphine. The main risk associated with morphine toxicity is respiratory depression, which may be fatal.
In 2012/13, the EU Pharmacovigilance Risk Assessment Committee (PRAC) undertook an Article 31 review of the risk of life-threatening or fatal respiratory depression in children after taking codeine for the treatment of pain and agreed risk-minimisation measures restricting use in order to maintain a positive benefit risk balance. Changes were made to the Summaries of Product Characteristics to reflect these variations in the licences and information was also communicated directly to healthcare professionals on an EU and National basis.
This descriptive study will examine the patterns of prescribing of codeine-containing products with an indication for the treatment of pain in children in the period 2010-2015 in the UK in relation to these risk minimisation measures. The results will inform the PRAC on the impact of the new measures and the effectiveness of the communication strategy and is being performed as part of a wider collaborative study in which a common protocol will be used to examine electronic healthcare record data from four EU countries (UK, France, Germany, and Spain). Summary statistics only will be used.
Source
2015 - 10
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The association between Huntington's disease and cancer before and after the Huntington's diagnosis - a two-phase study — Rachael Williams ...
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The association between Huntington's disease and cancer before and after the Huntington's diagnosis - a two-phase study
Datasets:GP data, HES Admitted Patient Care; NCRAS Cancer Registration Data; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-05
Organisations:
Rachael Williams - Chief Investigator - CPRD
Daniel Dedman - Corresponding Applicant - CPRD
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Michael Rawlins - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Nancy Wexler - Collaborator - Columbia University
Stephen Evans - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
HD is an autosomal dominant condition usually presenting in mid-life. It is due to an expanded CAG repeat on the short arm of chromosome 4. As a consequence the gene product, an abnormal form of the protein huntingtin, has an expanded polyglutamine tract that accumulates in neuronal cells and causes cell death.
It has been postulated that the mutant HD gene product protects against malignant disease and previous studies (Sorensen and Fenger 1992, 1999; Ji et al 2012) have claimed to show this. These studies, however, were conducted in people with symptomatic HD and it is possible that such patients either failed to present with relevant symptoms; or that their healthcare professionals failed to investigate them because of their poor state of health and/or their poor prognosis.
We plan to undertake a two phase study of the frequency of cancer diagnoses among both symptomatic, and presymptomatic, patients with HD compared with the frequency of cancer diagnoses in matched controls. By examining the frequency of cancer in symptomatic HD patients it should be possible to confirm or refute the previous evidence suggesting a reduced frequency of malignant disease in patients with diagnosed HD. By examining the frequency of malignancy in presymptomatic HD patients, compared to controls, we hope to avoid the potential diagnostic bias that may have affected previous studies among those with manifest HD.
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The risk of depression and suicidality in patients with psoriasis, psoriatic arthritis or ankylosing spondylitis: a retrospective United Kingdom database analysis — Christopher Morgan ...
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The risk of depression and suicidality in patients with psoriasis, psoriatic arthritis or ankylosing spondylitis: a retrospective United Kingdom database analysis
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-07
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Haijun Tian - Collaborator - Novartis Pharmaceuticals Corporation
Paola Primatesta - Collaborator - Novartis Pharma AG
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
This study aims to estimate the incidence of depression and suicidality in patients identified with psoriasis, psoriatic arthritis (PsA) or ankylosing spondylitis (AS), compared with the general population, using a retrospective cohort design. Patients with incident diagnoses between 1st January 2000 and 30th June 2015 will be extracted. Controls will be matched by age (+/- two years), gender and primary-care practice at a ratio of 5:1. All non-exposed controls will be required to have had a primary-care contact within +/-60 days of their respective case's index date. Psoriasis patients will be further divided into mild and moderate/severe groups based on prescribed therapy. Outcomes will be defined by Read or ICD-10 code. Crude incidence will be calculated based upon total observed outcomes divided by total follow-up time. Age- and gender-specific rates will also be calculated. Adjusted hazard ratios will be determined using Cox proportional hazard models adjusted for age, gender, previous history of depression or suicidality, Charlson index and previous health contacts. Sensitivity analyses will be conducted:
1) Including patients with a prior history of depression or suicidality
2) Excluding patients seen less than once per year on average to assess observation bias
3) Excluding patients with co-morbidity measured by the Charlson index.
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The association between lansoprazole and tuberculosis disease; a primary care based cohort study — Ian Douglas ...
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The association between lansoprazole and tuberculosis disease; a primary care based cohort study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-13
Organisations:
Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Krishnan Bhaskaran - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Laurie Tomlinson - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Sara Thomas - Collaborator - Not from an Organisation
Sinead Langan - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Thomas Yates - Collaborator - UCL HospitalOutcomes: none known
Description: Technical Summary
Our overall aim is to assess the effect of lansoprazole on the risk of tuberculosis disease. In order to achieve this we will estimate the relative risk of tuberculosis comparing people prescribed lansoprazole with people prescribed omeprazole or pantoprazole. We will construct a cohort of new users of lansoprazole and new users of omeprazole or pantoprazole and use Cox regression to estimate the hazard ratio for tuberculosis disease.
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A study of multifactorial intervention in type 2 diabetes and chronic kidney disease — Shota Hamada ...
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A study of multifactorial intervention in type 2 diabetes and chronic kidney disease
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-13
Organisations:
Shota Hamada - Chief Investigator - King's College London (KCL)
Shota Hamada - Corresponding Applicant - King's College London (KCL)
Martin Gulliford - Collaborator - King's College London (KCL)Outcomes: none known
Description: Technical Summary
Type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) are associated with mortality, development of cardiovascular disease (CVD), and declining of renal function (eg, progression to end-stage renal failure or ESRF). The frequency of CKD appears to be increasing in patients with T2DM. Evidence has emerged on the effectiveness of multifactorial interventions on mortality, including tight blood glucose control, renin-angiotensin system blockers, aspirin, and lipid-lowering drugs, at reducing mortality and progression of CKD in diabetic patients with persistent microalbuminuria. However, the effectiveness of this approach has not been verified yet in patients with T2DM and CKD. This study aims to evaluate the implementation of multifactorial intervention in diabetic patients with CKD over time. The study will also evaluate the association of a multifactorial intervention with mortality, CVD, progression to ESRF or renal replacement therapy, doubling of serum creatinine and acute kidney injury. Analyses will be adjusted for a wide range of confounders including duration of diabetes and deprivation category. Linked external datasets will contribute to evaluation of renal and cardiovascular outcomes and causes of deaths. This study will provide useful information about the implementation of multi-factorial intervention strategies into patients with T2DM and CKD.
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Incidence of corticosteroid related adverse events in inflammatory musculoskeletal conditions — Milica Bucknall ...
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Incidence of corticosteroid related adverse events in inflammatory musculoskeletal conditions
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-07
Organisations:
Milica Bucknall - Chief Investigator - Keele University
Kelvin Jordan - Corresponding Applicant - Keele University
Christian Mallen - Collaborator - Keele University
Samantha Hider - Collaborator - Keele University
Trishna Rathod-Mistry - Collaborator - Keele UniversityOutcomes: none known
Description: Technical Summary
The objective is to assess the relationship of prescribed prednisolone with incidence of diabetes, hypertension, obesity, cataracts and glaucoma within patients with rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR). We will identify patients with a diagnosis of RA or PMR between 2000-2010 and with a new prescription of prednisolone and follow them for up to 15 years to assess incidence of the outcome morbidities, comparing by duration and dosage of prednisolone, and to RA and PMR patients without a prescription of prednisolone. The study includes a substantial methodological aspect as care needs to be taken when using observational data to estimate treatments effects because of the non-randomized nature of the groups. Treatment decisions will be influenced by pre-treatment characteristics (covariates) which may relate to subsequent outcome. We will use propensity score methodology to address such confounding by indication. The approach involves calculating, and incorporating into analyses, the propensity (likelihood) of each patient to receive steroids or a particular dosage of steroids, given their observed covariates. We will explore use of propensity scores when treatment (e.g. prednisolone dosage) varies over time, or when there are missing information on observed covariates, and address the potential impact on our findings of unmeasured patient characteristics.
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An Epidemiological Study Examining the Risk of Serious Adverse Effects Associated with Corticosteroid Therapy in Rheumatoid Arthritis (RA) Patients — Christoph Meier ...
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An Epidemiological Study Examining the Risk of Serious Adverse Effects Associated with Corticosteroid Therapy in Rheumatoid Arthritis (RA) Patients
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-11
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Jessica Claire Wilson - Corresponding Applicant - Queen's University Belfast
Alexandra Mills - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Attila Petho Schramm - Collaborator - F. Hoffmann - La Roche Ltd
Khaled Sarsour - Collaborator - Genentech - Roche Company
Pavel Napalkov - Collaborator - Roche
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance ProgramOutcomes: none known
Description:
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Determinants of Zoster vaccination acceptance in people eligible for NHS shingles vaccination programme — Helene Bricout ...
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Determinants of Zoster vaccination acceptance in people eligible for NHS shingles vaccination programme
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-27
Organisations:
Helene Bricout - Chief Investigator - Sanofi Pasteur MSD ( closed )
Ana Wheelock - Collaborator - Imperial College London
Coralie Lecomte - Collaborator - IQVIA (Quintiles) France
Emma Boyle - Collaborator - Not from an Organisation
Laurence Torcel-Pagnon - Collaborator - Sanofi Pasteur MSD ( closed )
Nick Sevdalis - Collaborator - King's College London (KCL)
Stephane Thomas - Collaborator - Sanofi Pasteur MSD ( closed )
Xavier Cornen - Collaborator - Sanofi Pasteur MSD ( closed )Outcomes: none known
Description: Technical Summary
The main objective of this non-interventional case-control study is to explore the determinants of the acceptance of the shingles vaccination in adults who were eligible for National Health Service (NHS) shingles vaccination programme in the United Kingdom, by comparing vaccinated patients with unvaccinated patients. We will leverage Clinical Practice Research Datalink (CPRD) general practitioners (GPs) network. This study also aims to describe the patients' population, to identify the sources of information that influenced the patient decision-making process and to assess the physician's opinion concerning the perceived barriers to Zoster vaccination.
Self-administered questionnaires will be distributed to patients aged 80 years and their GPs.
The study is based on the concept of Health Belief Model (HBM) that explains health seeking-behaviour by assessing how people perceive their susceptibility to a disease, the severity of the disease, as well as benefits or usefulness of taking a new behaviour in preventing the disease, and barriers to follow a preventive action. The underlying concept is that health behaviours are determined by personal beliefs or perceptions about a disease and the strategies available to minimise its occurrence. The model has been used in several studies to understand the differences between vaccinated and non-vaccinated people.
The patient questionnaire will collect socio-demographics, health status, as well as constructs from the health belief model.
The physician questionnaire will collect demographics, practice location, vaccine recommendations for elderly patients, communication campaign for Zoster vaccination and perceived barriers to Zoster vaccination. The patients' vaccination status, gender, year of birth, GPs' practice size and nation will be obtained from CPRD database.
The patients' and GPs' population will be described. The association between Zoster vaccination and beliefs expressed by the patients, modifying factors and cues to action will be assessed using a multivariate logistic regression model.
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Effects of pulmonary rehabilitation on exacerbation number and severity in people with Chronic Obstructive Pulmonary Disease — Jennifer Quint ...
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Effects of pulmonary rehabilitation on exacerbation number and severity in people with Chronic Obstructive Pulmonary Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-05
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Jennifer Quint - Corresponding Applicant - Imperial College London
Michael Soljak - Collaborator - Imperial College London
Miland Joshi - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
As a national sample of current practice, we will use linked CPRD GOLD data with HES and ONS to undertake a cohort study followed by a regression analysis.
We will compare exacerbation numbers and severity in people with COPD who have and have not participated in pulmonary rehabilitation, taking into account the fact that not everyone is eligible for the programme. The information obtained from this study will be used to inform the development of models which can then be used as a national resource.
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Disease burden of diabetes patients with high dose insulin treatment in CPRD — Xiaomei Peng ...
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Disease burden of diabetes patients with high dose insulin treatment in CPRD
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-28
Organisations:
Xiaomei Peng - Chief Investigator - Eli Lilly & Co Ltd - US Headquarters
Dingfeng (Daniel) Jiang - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Elemer Balogh - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Iskandar Idris - Collaborator - University of Nottingham
Kate Van Brunt - Collaborator - Eli Lilly & Co Ltd - US HeadquartersOutcomes: none known
Description: Technical Summary
Objectives: The purpose is to assess the treatment patterns, disease burden, and characteristics of patients in UK with diabetes who are using insulin, with a particular focus on patients who are prescribed high daily doses (>200 units/day) of insulin, to achieve optimal glucose target and the change of treatment pattern in recent years.
Methods: A retrospective analysis will be conducted using the data from clinical practical research datalink (CPRD). A cohort of patients with diabetes who are currently using insulin will be identified and grouped into four categories based on the amount of insulin total daily dose (TDD): group 1: TDDâ¤200 units/day; group 2: 200units/day<TDDâ¤300units/day; group 3: 300units/day<TDDâ¤600units/day; group 4: TDD>600 units/day. The patientsâ demographic and clinical characteristics, including concomitant medications, comorbidities and resource utilization will be analysed.
Data analysis: Descriptive statistics will be used for describing the characteristics of high dose insulin users, as well as the general insulin users. The trend of using high dose insulin will be assessed by the Cochran-Armitage trend test and Generalized Estimating Equations (GEE) for the incidence and prevalence of patients, respectively. Chi-square test and two sample T test will be used appropriately to compare the characteristics of different insulin user groups.
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An evaluation of the epidemiology and burden of illness of congenital adrenal hyperplasia in the United Kingdom — Craig Currie ...
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An evaluation of the epidemiology and burden of illness of congenital adrenal hyperplasia in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-04
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Martin Whitaker - Collaborator - University of Sheffield
Richard Ross - Collaborator - University of Sheffield
Sarah Holden - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
We aim to evaluate the burden of congenital adrenal hyperplasia (CAH) in a UK population: analysing the risk of mortality and depression in a retrospective matched cohort study, estimating excess healthcare costs, and describing causes of death, therapy adherence, and clinical manifestations. We will use primary-care data from CPRD GOLD and, where linked, ONS mortality data and inpatient and outpatient data from the Hospital Episode Statistics (HES).
Patients with a CAH diagnosis in CPRD GOLD or HES and at least one corticosteroid prescription will be selected and matched 1:10 with non-exposed patients. Risk of death, as recorded in CPRD GOLD, will be compared using a Cox proportional hazards model; a sensitivity analysis will examine deaths from the ONS data. Lifetime prevalence of depression, identified by diagnosis or antidepressant prescription, will be compared by chi-square test; a sensitivity analysis will examine depression identified by diagnosis alone. In HES-eligible patients, rates and costs of health-service use will be compared between CAH patients and controls using the Mann-Whitney U-test. Causes of death in CAH patients, as recorded by the ONS; corticosteroid adherence measured by medical possession ratio; and the clinical manifestations of the condition at key life stages will be tabulated non-comparatively.
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Prediagnostic presentations and comorbidities of multiple sclerosis in primary care: a case-control study — Giulio Disanto ...
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Prediagnostic presentations and comorbidities of multiple sclerosis in primary care: a case-control study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-27
Organisations:
Giulio Disanto - Chief Investigator - Neurocentre of Southern Switzerland
Giulio Disanto - Corresponding Applicant - Neurocentre of Southern Switzerland
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political ScienceOutcomes: none known
Description: Technical Summary
Multiple sclerosis has an insidious onset and is diagnosed after a historical review of events in a patient's life, findings observed on neurological examination, data acquired from diagnostic tests, and after the exclusion of other diseases that could account for the clinical and paraclinical findings. Several motor and non-motor features can occur before diagnosis, early in the disease process. This study aims to assess the association between first presentation of several symptoms in primary care and a subsequent diagnosis of multiple sclerosis, and to chart the timeline of these first symptom presentations before multiple sclerosis diagnosis. Individuals with a first diagnosis of multiple sclerosis in CPRD until July 31, 2015 will be identified and a matched control cohort will be created of patients without multiple sclerosis. The frequency of a wide range of possible prediagnostic or early symptoms, comprising including motor features, autonomic features and neuropsychiatric disturbances in the years before multiple sclerosis diagnosis will be calculated. The incidence of symptoms recorded in more than 1% of cases per 1000 person-years and incidence risk ratios (RRs) for individuals with and without multiple sclerosis at 2, 5, and 10 years before diagnosis will be reported. Insight into the first clinical presentations of prediagnostic symptoms would help to delineate the pathophysiology of early multiple sclerosis progression and to identify people at increased risk of development of overt multiple sclerosis who would be eligible for inclusion in clinical trials of neuroprotective strategies.
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Predicting individual risk of future hip and knee replacement for osteoarthritis — Dahai Yu ...
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Predicting individual risk of future hip and knee replacement for osteoarthritis
Datasets:GP data, Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-29
Organisations:
Dahai Yu - Chief Investigator - Keele University
George Peat - Corresponding Applicant - Keele University
Avril Poyner - Collaborator - Not from an Organisation
Christine Walker - Collaborator - Keele University
Daniel Prieto-Alhambra - Collaborator - University of Oxford
John Edwards - Collaborator - Keele University
Kelvin Jordan - Collaborator - Keele University
Vincent Ukachukwu - Collaborator - Keele UniversityOutcomes: none known
Description: Technical Summary
To advance knowledge of individual patient prognosis for osteoarthritis, we propose to derive and internally validate multivariable models to predict the risk of future primary hip and knee replacement in an open cohort of patients aged â¥40 years presenting to general practice with osteoarthritis or hip pain or knee pain in the period 1993-2015. Our study has 5 main phases: (i) evaluating in the primary care record the feasibility of using prognostic factors identified from a systematic literature review; (ii) a case-control study to discover other potential prognostic factors available in the primary care record. (iii) determining a final candidate list of prognostic factors through consultation with our expert collaborators, panel of GPs, and Research User Group members; (iv) derivation, internal validation, evaluation of discrimination/calibration of multivariable risk prediction models for primary hip arthroplasty and primary knee arthroplasty using Cox proportional hazards models; (v) secondary analyses to evaluate sources of bias, model assumptions, and model performance in specified subgroups (e.g. at point of first OA diagnosis). A future ambition, beyond the scope of this proposal, is to explore with our collaborators opportunities to externally validate our multivariable risk prediction models in primary care databases in Spain.
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Morbidity among HIV-positive people in England: a cross-sectional, population-based CALIBER study — Patricia McGettigan ...
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Morbidity among HIV-positive people in England: a cross-sectional, population-based CALIBER study
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-27
Organisations:
Patricia McGettigan - Chief Investigator - Queen Mary University of London
Patricia McGettigan - Corresponding Applicant - Queen Mary University of London
Daniel Morales - Collaborator - University of Dundee
Marina Daskalopoulou - Collaborator - University College London ( UCL )
Nashaba Matin - Collaborator - Royal London Hospital
Spiros Denaxas - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
We wish to describe the prevalence of morbidities and of multi-morbidity (two or more morbidities other than HIV) among HIV-positive people living in England and to compare the prevalence rates with those among age- and sex-matched HIV-negative controls. To do so, we will undertake a retrospective observational cohort study. Using the CPRD and Hospital Episode Statistics (HES) data, individuals with diagnoses of HIV infection will be identified as will a comparator non-HIV-positive cohort in a ratio of 4:1 to the HIV-positive cohort. Economic and social data will be obtained and linked from the Office of National Statistics The cohorts will be matched for sex, age-group, and Index of Multiple Deprivation quintile.
Using validated algorithms, we will identify in both cohorts the presence of nine morbidities [diabetes, congestive heart failure, acute myocardial infarction, hypertension, asthma, chronic obstructive lung disease, stroke, renal disease, peripheral vascular disease] and of multi-morbidity (two or more morbidities other than HIV). Morbidities will be identified by their relevant Read (CPRD) and ICD-10 (HES) codes. For individual morbidities and for multi-morbidity, we will calculate the cohort prevalence ratios with 95% confidence intervals. Sex, age-group, and Index of Multiple Deprivation quintile will be described as categorical variables and compared between the cohorts using chi-squared tests.
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Usage Patterns of Selected Systemic NSAIDs (Including Diclofenac): A Retrospective Cohort Study — Elena Rivero...
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Usage Patterns of Selected Systemic NSAIDs (Including Diclofenac): A Retrospective Cohort Study
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-18
Organisations:
Elena Rivero-Ferrer - Chief Investigator - RTI Health Solutions
Catherine Saltus - Corresponding Applicant - RTI Health Solutions
Alan Silman - Collaborator - University of Oxford
Jennifer Bartsch - Collaborator - RTI Health Solutions
John. T Farrar - Collaborator - University of Pennsylvania
Jordi Castellsague - Collaborator - RTI Health Solutions
Kristijan Kahler - Collaborator - Novartis Pharmaceuticals Corporation
Marc C. Hochberg - Collaborator - University Of Maryland
Maria Reynolds - Collaborator - RTI Health Solutions
Samik Banerjee - Collaborator - NOVARTIS
Shaloo Pandhi - Collaborator - Novartis Pharma AGOutcomes: none known
Description: Technical Summary
The study aims to accomplish the following:
- Describe demographic characteristics, specific comorbidities, selected comedications, and selected potential indications for use among patients treated with selected systemic NSAIDs (including diclofenac)
- Describe treatment patterns, including dose, duration of treatment, and switching patterns, among patients treated with selected systemic NSAIDs (including diclofenac)This will be a non-interventional, retrospective drug utilization study, using a cohort design, of users of selected systemic NSAIDs. Cohorts of prevalent users of selected systemic NSAIDs will be characterized at baseline according to age, sex, prior specific comorbidities, selected comedications, and health care resource use.
A subset cohort of new users of each selected NSAID will be characterized (1) at baseline according to age, sex, prior specific comorbidities, selected comedications, health care resource use, and selected potential indication; and (2) during the 1-year follow-up period to assess the pattern of use of the NSAID including duration, dose, use of more than one NSAID, switching, and persistence and adherence to therapy.
All study measures will be analyzed descriptively through the tabular and graphical display of mean values, medians, ranges, and standard deviations for continuous variables of interest and proportions for categorical variables (with corresponding 95% confidence intervals, as appropriate).
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Statins for Prevention of Cardiovascular Disease in Older Primary Care UK Patients — David Melzer ...
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Statins for Prevention of Cardiovascular Disease in Older Primary Care UK Patients
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-01
Organisations:
David Melzer - Chief Investigator - University of Exeter
Alessandro Ble - Corresponding Applicant - University of Exeter
Adam Streeter - Collaborator - University of Exeter
Jane Masoli - Collaborator - University of Exeter
Joao Delgado - Collaborator - University of Exeter
Jose M Valderas - Collaborator - University of Exeter
Kirsty Bowman - Collaborator - University of Exeter
Peter Hughes - Collaborator - University of Exeter
Ruben Mujica Mota - Collaborator - University of Exeter
William Henley - Collaborator - University of ExeterOutcomes: none known
Description: Technical Summary
The primary objective is to assess the effectiveness of statins for prevention of myocardial infarction (MI). Secondarily, we aim to explore selected potential adverse reactions, the effect of age and burden of disease on statins effectiveness, and the cost-effectiveness of statins.
To do this, a retrospective parallel cohorts study will be constructed in a sample of 60+ CPRD patients. Statins (class) receipt will be the exposure and MI and IS the primary endpoints. Selected adverse reactions (i.e. falls/fractures, Parkinsonâs disease, Alzheimerâs disease, ischemic stroke and death), and costs (derived by extracting health-care utilisation measures from CPRD and deriving Healthcare Resource Group categories from Hospital Episode Statistics) and QALYs (based on observed outcomes and data from the literature) will also be investigated as secondary endpoints.
Main hypotheses will be tested by using Cox regressions; effect of age and disease burden by interaction terms; confounding will be addressed by propensity score and difference in difference methods (when applicable). Missing-at-random will be assumed and data will be explored to investigate this assumption. Decision modelling will be used to synthesise the results of CPRD-HES data analysis, existing evidence from the literature and expert opinion for cost-effectiveness analysis.
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Investigation of long-term outcomes and healthcare utilisation of survivors of critical illness — David Menon ...
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Investigation of long-term outcomes and healthcare utilisation of survivors of critical illness
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-05
Organisations:
David Menon - Chief Investigator - University of Cambridge
Rupert Payne - Corresponding Applicant - University of Bristol
Ari Ercole - Collaborator - Cambridge University Hospitals
David Harrison - Collaborator - ICNARC
Kirsty Rhodes - Collaborator - University of Cambridge
Rebecca Turner - Collaborator - University of CambridgeOutcomes: none known
Description: Technical Summary
The long-term sequelae in survivors of intensive care are unknown, and it is important that we develop a better understanding of long-term health complications and health services utilisation. This will be achieved by comparing long-term outcomes of survivors of critical care with those individuals of similar previous health status who have not experienced a stay in critical care. This will be achieved by linking the UK national intensive care database (ICNARC) to GP and hospital episode statistics records in CPRD. Our key health service outcomes of interest are frequency/time-course of primary care consultations, prescribing burden, frequency of specialist referrals, frequency of hospital admissions, and number of hospital bed-days. Key index morbidities of interest are dementia/cognitive dysfunction, and chronic kidney disease (CKD). Rates of admission/consultation/referral/prescribing will be modelled using Poisson or negative binomial regression, as well as joint modelling with survival. Survival models will be constructed for the development of dementia/CKD. Multivariable mixed-effects regression will be employed to adjust for key covariates/confounders and clustering. The results of this study will be valuable for optimising health service delivery and improving care for people following discharge from an ICU.
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Estimating the healthcare use and costs of children born to pregnant smokers — Lisa Szatkowski ...
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Estimating the healthcare use and costs of children born to pregnant smokers
Datasets:GP data, CPRD Mother-Baby Link; HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-11
Organisations:
Lisa Szatkowski - Chief Investigator - University of Nottingham
Timothy Coleman - Corresponding Applicant - University of Nottingham
Laila Tata - Collaborator - University of Nottingham
Luis Vaz - Collaborator - University of Nottingham
Matthew Jones - Collaborator - University of Nottingham
Stavros Petrou - Collaborator - University of WarwickOutcomes: none known
Description: Technical Summary
The objective of this study is to use Hospital Episode Statistic (HES)-linked Clinical Practice Research Datalink (CPRD) data to provide descriptive statistics for the number of primary and secondary care consultations experienced by infants and children of pregnant women who are smokers and non-smokers. Means and standard deviations will be produced to describe the overall number of primary and secondary care consultations. Furthermore, this study also aims to test whether or not overall healthcare utilisation varies with smoking behaviour in pregnancy. Poisson regression will be used to provide rate ratios and 95% confidence intervals (CI) for healthcare consultation rates. Generalised estimating equations will be used to cluster by mother, for women who have had more than one child during the follow-up period. The costs of delivering primary and secondary care consultations will be calculated using standard reference sources and appropriate, smoking-attributable costs of healthcare utilisation will be used within the Economic model of Smoking In Pregnancy (ESIP) to improve the accuracy of model estimates.
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Evaluation of the clinical and economic outcomes associated with Bydureon versus basal insulin in people with type 2 diabetes — Craig Currie ...
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Evaluation of the clinical and economic outcomes associated with Bydureon versus basal insulin in people with type 2 diabetes
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-01
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Bethan Jones - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Kristina Johnsson - Collaborator - Astra Zeneca Inc - USA
Qing Qiao - Collaborator - Astra Zeneca Ltd - UK Headquarters
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Susan S Grandy - Collaborator - Astra Zeneca Inc - USAOutcomes: none known
Description: Technical Summary
We wish to compare outcomes for T2DM patients treated with therapeutic regimens involving exenatide QW with those involving basal insulin-based therapies. T2DM patients will be selected from the CPRD GOLD, HES and ONS datasets. Those identified as being initiated on the target therapies between 2009 and 2014 will be extracted and their characteristics described. We will then match exenatide QW patients (cases) to basal insulin patients (controls) on key characteristics. For the primary objectives we wish to compare change in HbA1c and change in weight independently and as combined endpoints based on patients achieving a fall in HbA1c below 7.0% accompanied with a) any weight loss and b) weight loss of >/= 5% of baseline. Secondary objectives are to compare cost of primary and secondary care resource use, time to all-cause mortality and time to cardiovascular events. Times to endpoints will be compared using Cox proportional hazards models adjusting for demographic and clinical covariates. Change in weight and HbA1c will be compared using the Wilcoxon signed rank test. Health care costs will be estimated from standard tariffs and compared using the Mann-Whitney U-test. All analyses will be replicated based on patients prescribed exenatide (Byetta).
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The efficacy and safety of concomitant treatment with telmisartan, candesartan or bisoprolol in combination with amlodipine in patients with essential arterial hypertension: outcomes in real world practice — Craig Currie ...
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The efficacy and safety of concomitant treatment with telmisartan, candesartan or bisoprolol in combination with amlodipine in patients with essential arterial hypertension: outcomes in real world practice
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-11
Organisations:
Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
The aim of this study is to evaluate the effectiveness and safety of concomitant treatment with telmisartan and amlodipine or bisoprolol and amlodipine for the treatment of hypertension to support the marketing authorisation application of fixed-dose combinations. A retrospective cohort study will be conducted using data from the Clinical Practice Research Datalink (CPRD). Patients with essential arterial hypertension prescribed telmisartan, bisoprolol or amlodipine at a stable dose followed by augmentation of antihypertensive therapy using the other monocomponent will be identified from CPRD. The index date will be defined as the date that telmisartan or bisoprolol are prescribed in combination with amlodipine. Other antihypertensive agents can be prescribed concomitantly provided they are not initiated or modified less than one month prior to the index date. Patients with secondary hypertension will be excluded. Study subjects will be matched to a reference group whose antihypertensive therapy (telmisartan, bisoprolol or amlodipine) is augmented with an additional antihypertensive agent other than telmisartan, bisoprolol or amlodipine. Change in systolic and diastolic blood pressure between baseline and 30-150 days and 90-270 days post index will be investigated. The incidence of safety events of interest reported in the first year post index will be calculated.
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Developing insights into treatment of chronic/diabetic kidney disease (CKD/DKD) using real world data — Guilhem Pietri ...
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Developing insights into treatment of chronic/diabetic kidney disease (CKD/DKD) using real world data
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-01
Organisations:
Guilhem Pietri - Chief Investigator - PAREXEL International Corporation
Canter Martin - Corresponding Applicant - PAREXEL International Corporation
Chi Thi Le Truong - Collaborator - PAREXEL International Corporation
Hilary Phelps - Collaborator - PAREXEL International CorporationOutcomes: none known
Description: Technical Summary
Objectives: The primary objective is to delineate treatment patterns in patients with CKD or DKD, with or without heart failure (HF), by conducting a longitudinal and retrospective analysis of CPRD data. Secondary objectives include describing cohort characteristics, evaluating clinical outcomes, and evaluating resource utilisation and costs.
Methods: Data for this retrospective and observational study will be obtained from the CPRD GOLD dataset linked with Hospital Episode Statistics (HES) and the Office of National Statistics (ONS) for mortality. The index period will run from 1 January 2008 to 31 March 2012, with a 12-month baseline period and 2-year follow-up period. The index date will be defined as the first prescription for a CKD/DKD-related medication.
Data analysis: Within each cohort, demographic and clinical characteristics will be described using summary statistics. Treatment pathways will be analysed including maps for consecutive lines of therapies during the follow-up period, duration of each line of therapy, reasons for initiation and discontinuation, and treatment adherence (measured with the medication possession ratio [MPR]). Therapy distributions between the cohorts will be compared using chi-square tests. Time to therapy change will be assessed by Kaplan-Meier estimates. Annualised resource utilisation and patient outcomes will also be analysed.
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What is the burden of foot and ankle pain in the general population of the United Kingdom as recorded by General Practitioners? — Catherine Bowen ...
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What is the burden of foot and ankle pain in the general population of the United Kingdom as recorded by General Practitioners?
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-10-05
Organisations:
Catherine Bowen - Chief Investigator - University of Southampton
Rachel Ferguson - Corresponding Applicant - Solent NHS Trust, Podiatry
Andrew Judge - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Nigel Arden - Collaborator - University of SouthamptonOutcomes: none known
Description: Technical Summary
The main goal of this study is to identify how many people general practitioners (doctors) record as having foot and ankle pain at a given time (between January and December of each year between 2004 and 2014) and how many new cases they record over a period of time (January to December each year between 2004 and 2014). This information will also be separated by: age groups (0-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80-89, 90+), gender (male/ female) and living and financial characteristics of people.
We will look at those with foot and ankle pain to see if they have similar illnesses, particularly bone, muscle or joint problems or diabetes, whether they smoke, consume alcohol and how much they weigh.
Finally, we will look to see how people with foot or ankle pain use medication (tablets) to help improve pain, how many appointments with their doctor they have for foot or ankle pain and if they have had any special tests organised or seen any specialists about the pain.
For each person with foot or ankle pain, three similar people without it will be provided allowing for comparison between those with and without foot and ankle pain.
Source
2015 - 09
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Healthcare resource utilisation and economic impact among liver transplant patients during the last year before graft failure in the UK: a retrospective observational study — Warren Hart ...
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Healthcare resource utilisation and economic impact among liver transplant patients during the last year before graft failure in the UK: a retrospective observational study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-10
Organisations:
Warren Hart - Chief Investigator - EcoStat Consulting UK Ltd.
Warren Hart - Corresponding Applicant - EcoStat Consulting UK Ltd.
Chris D Poole - Collaborator - Digital Health Labs Limited
Gorden Muduma - Collaborator - Astellas Pharma Europe B.V.Outcomes: none known
Description: Technical Summary
The primary objective of this study is the total cost of healthcare resource use observed in the year prior to the date of liver transplant failure. A secondary aim is to extend the analysis to between more than one and five years before graft failure.
This project will constitute a non-interventional, retrospective longitudinal study to analyse anonymous patient data from NHS databases. Patients will be selected from the CPRD/HES on the basis of evidence for liver transplantation between 2004 and 2013 and graft failure between 2005 and 2014.
Costs will be evaluated through models which are based on NHS national costs (2015) for health care consumption and BNF costs for drug utilisation.
The total cost of healthcare resource in the year prior to the graft failure will be analysed descriptively, in terms of distribution of costs, components of total cost and the relationship between individual resource items and total cost.
Continuous and nominal variables will be described using standard statistical measures such as number of observations, mean, standard deviation, minimum and maximum value, median, 1st and 3rd quartiles, and frequencies.
Repeated measures longitudinal modelling will be conducted to estimate the impact of time to graft failure on resource utilisation while adjusting for covariates.
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Coronary Artery Disease in the Ageing Population of Adults with Congenital Heart Disease — Michael A Gatzoulis ...
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Coronary Artery Disease in the Ageing Population of Adults with Congenital Heart Disease
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-03
Organisations:
Michael A Gatzoulis - Chief Investigator - Royal Brompton Hospital
Maria Boutsikou - Corresponding Applicant - Royal Brompton Hospital
Aleksander Kempny - Collaborator - Royal Brompton Hospital
Arturo Gonzalez-Izquierdo - Collaborator - University College London ( UCL )
George Giannakoulas - Collaborator - Aristotle University of Thessaloniki, Greece
Harry Hemingway - Collaborator - University College London ( UCL )
Konstantinos Dimopoulos - Collaborator - Royal Brompton Hospital
Mar Pujades Rodriguez - Collaborator - University of LeedsOutcomes: none known
Description: Technical Summary
The population of Adult Congenital Heart Disease (ACHD) patients presents with specific characteristics. There are multiple factors that may contribute to the development of Coronary Artery Disease (CAD) in these patients. Among them, the presence of abnormalities in the repaired or non repaired coronary arteries, the presence of endothelial dysfunction previously documented in patients with cyanotic congenital disorders, or associated conditions such as hypertension.
The aim of this study is to demonstrate the possible differences in the risk of developing CAD, the prognosis and the survival of ACHD population as compared to non ACHD population. Additionally, it will answer the question whether the already established risk models for CAD can be effectively used to assess the cardiovascular risks in the population of ACHD patients, opening the way for further research in this not extensively study area.
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Time to treatment intensification and associated outcomes among patients with Type 2 diabetes mellitus in the UK — Noam Kirson ...
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Time to treatment intensification and associated outcomes among patients with Type 2 diabetes mellitus in the UK
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-03
Organisations:
Noam Kirson - Chief Investigator - Analysis Group, Inc.
Urvi Desai - Corresponding Applicant - Analysis Group, Inc.
Jayanti Mukherjee - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Jennifer Kim - Collaborator - Astra Zeneca Ltd - UK Headquarters
Kamlesh Khunti - Collaborator - University of Leicester
Katherine Tsai - Collaborator - MedImmune
Nancy E Smith - Collaborator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Nebibe Varol - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Phillip Hunt - Collaborator - Astra Zeneca Inc - USA
Sarah King - Collaborator - Analysis Group, Inc.Outcomes: none known
Description: Technical Summary
The proposed study will assess time to treatment intensification among T2DM patients not achieving adequate glycemic control with metformin or sulfonylurea alone (defined as first glycated haemoglobin [HbA1c] measurement 7% or less after at least 3 months of metformin or sulfonylurea use) using Kaplan-Meier survival analyses. In addition, the study aims to describe the characteristics of patients receiving early intensification, intermediate intensification, or late intensification after initial indication of monotherapy failure. The precise definitions for these stratifications will be determined based on the distribution of time to intensification observed within the study sample to reflect the treatment patterns in the UK population. Furthermore, time to attaining HbA1c levels <7% will be described for those with early versus intermediate and early versus late intensification using Kaplan-Meier survival analyses. Finally, for a subgroup of patients with linked hospital data available, the association between differential times to treatment intensification and incidence of microvascular and macrovascular complications will be assessed using Cox proportional hazards models.
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Secondary prevention of acute coronary syndrome: comparative effectiveness of recommended vs. less intensive drug combination using Clinical Practice Research Datalink (CPRD). The SCARFACE-CPRD study. — Olaf Klungel ...
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Secondary prevention of acute coronary syndrome: comparative effectiveness of recommended vs. less intensive drug combination using Clinical Practice Research Datalink (CPRD). The SCARFACE-CPRD study.
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-27
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Julien Bezin - Corresponding Applicant - University of Bordeaux
Anthonius de Boer - Collaborator - Utrecht University
Antoine Pariente - Collaborator - University of Bordeaux
Bernard Begaud - Collaborator - University of Bordeaux
Patrick Souverein - Collaborator - Utrecht University
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )Outcomes: none known
Description: Technical Summary
This study is aimed to compare the morbidity and mortality in patients treated for secondary prevention after incident acute coronary syndrome with the recommended combination of four therapeutic classes (betablockers, antiplatelet agents, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) to that of incomplete combinations associating only three, two, one or none of the four recommended classes. A retrospective cohort analysis will be conducted in the United Kingdom Clinical Practice Research Database. The cohort will be constituted of adult patients who presented an incident acute coronary syndrome between 01/01/2005 and 31/12/2009 and survived at least three months after its occurrence. For each patient of the cohort, the exposure to the four therapeutic classes, to the recommended combination of the four therapeutic classes and to all possible incomplete combinations will be evaluated. The effectiveness of these therapeutic classes and combinations will be assessed considering the recurrence of acute coronary syndrome, incidence of ischemic stroke or all-cause death during follow-up. The incidence of the outcomes of interest will be determined for each therapeutic class and combinations according to a Cox model adjusted on potential time-fixed and time-dependent confounders and a marginal structural model using the inverse probability of treatment weighting approach.
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The risk of fragility fracture in inflammatory arthritis: evidence for the effective and equitable targeting of prevention — Anthony Woolf ...
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The risk of fragility fracture in inflammatory arthritis: evidence for the effective and equitable targeting of prevention
Datasets:GP data, Patient Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-21
Organisations:
Anthony Woolf - Chief Investigator - Royal Cornwall Hospital
Josephine Erwin - Corresponding Applicant - Royal Cornwall Hospital
Doyo Enki - Collaborator - Plymouth University
William Hamilton - Collaborator - University of ExeterOutcomes: none known
Description: Technical Summary
Objective
To provide evidence to enable prevention of fragility fractures to be targeted at, and provided with equity to, Patients with IA who will benefit most.
Aims
1. Calculate incidence rates of first and subsequent fragility fractures in adults with RA, PSA or AS.
2. Compare absolute risk of first and subsequent fragility fractures in adults with RA, PSA or AS and adults without these conditions.
3. Identify trends over time in fracture incidence.4. Estimate 5 and 10-year fracture risk in adults with RA, PSA or AS.
5. Identify clinically significant risk factors for first and subsequent fragility fractures in patients with RA, PSA or AS.
6. Identify clinical and socio-demographic predictors of pre and post fracture treatment of patients with RA, PSA or AS with bisphosphonate or denosumab.Methodology
Retrospective cohort study with matched control using data CPRD of adults 18 years and over with diagnosis of RA, PSA or AS recorded 1987-2014. Patients followed from index date to the first and subsequent fracture.
Data analysis
Cox proportional hazards model to identify risk factors for first and subsequent fractures. Multivariate logistic model of the clinical and socio-demographic predictors of pre and post fracture treatment of patients with RA, PSA or AS with bisphosphonate or denosumab.
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Assessing channelling bias and effectiveness in newly marketed glucose-lowering medications - a retrospective cohort study — Olaf Klungel ...
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Assessing channelling bias and effectiveness in newly marketed glucose-lowering medications - a retrospective cohort study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-14
Organisations:
Olaf Klungel - Chief Investigator - Utrecht University
Mikkel Zollner Ankarfeldt - Corresponding Applicant - Novo Nordisk UK
Brian Thorsted - Collaborator - Novo Nordisk
Johan Erpur Adalsteinsson - Collaborator - Novo Nordisk
Rolf H.H. Groenwold - Collaborator - University Medical Centre Utrecht
Sanni Ali - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Vinay Mehta - Collaborator - GSKOutcomes: none known
Description: Technical Summary
Channelling bias is a potential risk when relative effectiveness is investigated in a newly marketed drug compared to an established drug in observational data. We want to investigate the potential for channelling bias in glucose-lowering medication: as injectable treatments glucagon-like peptide-1 agonist (GLP-1) will be compared with insulin; and as oral treatments dipeptidyl peptidase-4 inhibitors (DPP-4) will be compared with sulfonylurea derivatives (SU). To investigate the potential for channelling bias the changes in patient characteristics over time in the users of the newly marketed drug will be compared to the users of the established drug. This will be done for patient characteristics separately as well as using a propensity score as a summary of patient characteristics. The magnitude of channelling bias will be investigated in both an intention-to-treat cohort and in a per-protocol cohort, where a comparison will be made between the new drugs and the established drugs, for oral and injectable treatments separately.
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Evidence for and implications of channeling in the use of nonprescription acetaminophen and ibuprofen in an electronic medical records database — Rachel Weinstein ...
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Evidence for and implications of channeling in the use of nonprescription acetaminophen and ibuprofen in an electronic medical records database
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-22
Organisations:
Rachel Weinstein - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Daniel Fife - Collaborator - Johnson & Johnson ( JnJ - USA )
Jesse Berlin - Collaborator - Ortho-McNeil-Janssen Pharmaceuticals - Johnson & Johnson Company
Kayur Patel - Collaborator - Janssen-Cilag Ltd
Patrick Ryan - Collaborator - Janssen Research & Development LLCOutcomes: none known
Description: Technical Summary
Previous studies have found an association between paracetamol and several adverse events, including upper gastrointestinal bleeding, myocardial infarction, stroke, acute renal failure and death. Some of these studies used ibuprofen as a comparator1,2 and when discussing the results it was common to raise the question of channeling but rare to offer evidence. Given an association is identified and is reproducible; the question is whether it is causal or reflects bias. One important candidate for a possible source of bias is channeling.
The primary objective is to determine whether there is channeling bias in the first prescription of paracetamol vs. ibuprofen in an electronic medical records database. A second objective is to repeat the analysis using negative control conditions as a way of calibrating the amount of residual variation inherent in the data source or study design. A third objective is to assess the prospects to reliably control for bias through adjustment methods. The findings would have bearing on any studies that compare adverse event rates among subjects exposed to paracetamol and subjects exposed to ibuprofen.
We will use the CPRD to form a cohort of patients given a first prescription of single-ingredient paracetamol or ibuprofen. Frequencies of prior gastrointestinal bleeding, myocardial infarction, stroke, ant acute renal failure, each in turn, will be calculated to determine whether channeling was present. In validation, we will examine frequencies of prior diagnoses of approximately 36 negative control conditions which are known not to be associated with use of paracetamol versus ibuprofen. Additionally, a propensity score analysis will be performed to determine the proportion of overlap of factors that predict first prescription of paracetamol or ibuprofen.
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The incidence of Guillain-Barre Syndrome in the United Kingdom from April 2005 to March 2015. — Germano Ferreira ...
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The incidence of Guillain-Barre Syndrome in the United Kingdom from April 2005 to March 2015.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-13
Organisations:
Germano Ferreira - Chief Investigator - Not from an Organisation
Kaatje Bollaerts - Collaborator - P95
Thomas Verstraeten - Collaborator - P95
Tom Cattaert - Collaborator - P95Outcomes: none known
Description: Technical Summary
Knowledge of background incidence rates in the general population is key to assess adverse events suspected to be associated with health interventions. As the seasonality of Guillain-Barre syndrome (GBS) is not well understood, large epidemiological databases are a potential resource to better understand rates and seasonal variations of GBS.
The objective of this study is to determine the incidence rates and seasonality of GBS in the UK general population.
This is a cohort database study based on the number of cases of GBS and total person-time at risk from April 2005 to March 2015 in the UK CPRD and inpatient HES.
Person-time at risk will be calculated for all subjects with censoring applied at the time of death, date of diagnosis, disenrollment from the medical practice or last collection date.
Cases of GBS are defined as those subjects for whom an incident event of GBS was recorded using READ or ICD-10 diagnostic codes.
Analysis: Incidence rates with 95% confidence intervals, by age group, gender, geographical region and study season (October to March; April to September). The season 1st October 2014- 31st March 2015 will be compared to prior winter seasons by estimating the incidence rate ratio and 95% confidence intervals.
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Study to investigate the drug treatment for sialorrhoea in children over the past 10 years. — Simon Bryson ...
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Study to investigate the drug treatment for sialorrhoea in children over the past 10 years.
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-17
Organisations:
Simon Bryson - Chief Investigator - Proveca Ltd.
Helen Shaw - Corresponding Applicant - Proveca Ltd.
Helen Shaw - Collaborator - Proveca Ltd.Outcomes: none known
Description: Technical Summary
The proposed research aims to analyse the use of glycopyrronium bromide (GB) in paediatric prescribing for sialorrhoea (CPD) in children below the age of 18 years in the UK. This data will be presented as summary statistics to both establish the general prescribing pattern for sialorrhoea and the use pattern of (GB). The overlap of the dataset will allow the sponsor to determine the pattern of prescribing of GB for sialorrhoea in the community. This will in turn be used to estimate UK wide use of GB in the community setting as related to the information available in the Prescription Cost Analysis (PCA) database. The data will be presented to the European Medicines Agency (EMA) to provide support for the well-established use, over 10 years, of GB for the treatment of CPD in the UK.
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Healthcare resource utilisation and economic impact among kidney transplant patients during the last year before graft failure in the UK: a retrospective observational study — Warren Hart ...
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Healthcare resource utilisation and economic impact among kidney transplant patients during the last year before graft failure in the UK: a retrospective observational study
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-10
Organisations:
Warren Hart - Chief Investigator - EcoStat Consulting UK Ltd.
Warren Hart - Corresponding Applicant - EcoStat Consulting UK Ltd.
Chris D Poole - Collaborator - Digital Health Labs Limited
Gorden Muduma - Collaborator - Astellas Pharma Europe B.V.Outcomes: none known
Description: Technical Summary
The primary objective of this study is the total cost of healthcare resource use observed in the year prior to the date of kidney transplant failure. A secondary aim is to extend the analysis to between more than one and five years before graft failure.
This project will constitute a non-interventional, retrospective longitudinal study to analyse anonymous patient data from NHS databases. Patients will be selected from the CPRD/HES on the basis of evidence for kidney transplantation between 2004 and 2013 and graft failure between 2005 and 2014.
Costs will be evaluated through models which are based on NHS national costs (2015) for health care consumption and BNF costs for drug utilisation.
The total cost of healthcare resource in the year prior to the graft failure will be analysed descriptively, in terms of distribution of costs, components of total cost and the relationship between individual resource items and total cost.
Continuous and nominal variables will be described using standard statistical measures such as number of observations, mean, standard deviation, minimum and maximum value, median, 1st and 3rd quartiles, and frequencies.
Repeated measures longitudinal modelling will be conducted to estimate the impact of time to graft failure on resource utilisation while adjusting for covariates.
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Can Continuity Of Primary Care Decrease Unscheduled Secondary Care Use? — Richard Morris ...
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Can Continuity Of Primary Care Decrease Unscheduled Secondary Care Use?
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-09-14
Organisations:
Richard Morris - Chief Investigator - University of Bristol
Chris Salisbury - Collaborator - University of Bristol
Daniel Lasserson - Collaborator - University of Birmingham
Fiona MacKichan - Collaborator - University of Bristol
Peter Tammes - Collaborator - University of Bristol
Sarah Purdy - Collaborator - University of BristolOutcomes: none known
Description: Technical Summary
Evidence suggests that many NHS patients presenting for unscheduled secondary care could be managed in primary care, thus aspects of general practice might be associated with unscheduled care. Current work by the investigators, including a published systematic review, suggest continuity of care as a potential influence.
We will obtain data from CPRD, linked with Hospital Episode Statistics (HES) data concerning emergency hospital admissions in 2012-14. Our ultimate purpose is to examine whether better continuity of care (as defined by a ready-made index) is associated with fewer emergency admissions, after adjustment for relevant confounding factors. The purpose of the current proposal will be to investigate the suitability of the data to address this hypothesis. We will request data on 10,000 patients aged over 65: while this will not have sufficient power to address the ultimate hypothesis, it will allow us to estimate the emergency admission rate, and assess its concordance with official national averages. We will assess agreement between both emergency admissions and ED attendances apparent in GP records, and those recorded in HES and will investigate disagreement, especially concerning mode of referral and discharge. Emergency admissions will be our primary outcome, however we will investigate ED attendances recorded by GPs.
Source
2015 - 08
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A drug utilisation cohort study of patients prescribed medicines from different classes of renin-angiotensin system blocking agents in UK primary care — Craig Allen ...
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A drug utilisation cohort study of patients prescribed medicines from different classes of renin-angiotensin system blocking agents in UK primary care
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-06
Organisations:
Craig Allen - Chief Investigator - MHRA
Craig Allen - Corresponding Applicant - MHRA
Katherine Donegan - Collaborator - MHRAOutcomes: none known
Description: Technical Summary
The objective of this study is to assess the outcome of regulatory advice issued by the MHRA in June 2014 in terms of the change in prescribing trends of RAS blocking agents in UK primary care. The drug utilisation study will utilise a retrospective cohort study design in a population of patients prescribed a RAS blocking agent between 01/01/2009 and 30/06/2015. The primary analysis will calculate the trends in prescribing before and after the publication of prescribing advice according to combination prescriptions of RAS blockers from different classes made on the same day. A sensitivity analysis will also look at combination prescriptions, which were made on different days within various time windows. The proportion of combination prescriptions which are prevalent (i.e. were already being prescribed prior to the publication of the new advice) and those which are incident (i.e. new combinations following the publication of the new advice) will also be calculated. Changes in the prescribing of RAS blockers in general will also be assessed as will the proportion of patients who have a prior record of heart failure or diabetic nephropathy in their medical history.
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Ethnicity and adherence to oral hypoglycaemic agents in T2DM — Michael Soljak ...
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Ethnicity and adherence to oral hypoglycaemic agents in T2DM
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-11
Organisations:
Michael Soljak - Chief Investigator - Imperial College London
Robert Watson - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Azeem Majeed - Collaborator - Imperial College London
Jonathan Valabhji - Collaborator - Imperial College London
Roger Newson - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
The objectives of this two-year (2013-2015) cross-sectional study are to determine whether there are associations between ethnicity and medication adherence to oral hypoglycaemic agents (OHAs), and ethnicity and HbA1c levels, in UK patients with type 2 diabetes mellitus (T2DM). We will also test whether adjustment for medication adherence alters the predictive value of ethnicity for HbA1c levels.
The population will include all patients >18-years with T2DM using OHAs. Patients will be grouped by ethnic category using the standard Office for National Statistics (ONS) 5-category classification. Medication adherence will be defined and analysed as âproportion of days coveredâ (PDC), both as a continuous variable, and PDC â¥0.8 (binary variable). Similarly continuous HbA1c (= mean over 2-year period) and binary HbA1c (= continuous measure collapsed into < or > 7.5% categories) outcome variables will be analysed.
Linear and logistic regression analyses will be used to determine whether there are associations between ethnicity and these outcome variables. We will calculate unadjusted and adjusted coefficients and odds ratios, with Huber-White standard errors, with the adjusted measures of effect accounting for various previously identified potential confounders. These confounders have been identified from extensive literature review and include demographic and socioeconomic factors, other prescriptions and comorbidities.
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Cluster Headache Patient Prevalence and Prescribed Treatments in the UK Clinical Practice Research Datalink — Evelyn M Flahavan ...
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Cluster Headache Patient Prevalence and Prescribed Treatments in the UK Clinical Practice Research Datalink
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-27
Organisations:
Evelyn M Flahavan - Chief Investigator - Roche
Andrew Ahn - Collaborator - Eli Lilly & Co Ltd - US Headquarters
James Michael Martinez - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Jonathan Swain - Collaborator - Eli Lilly & Co Ltd - US Headquarters
LUCY MITCHELL - Collaborator - Eli Lilly & Co - UK
Meghan Richards - Collaborator - Eli Lilly & Co Ltd - US HeadquartersOutcomes: none known
Description: Technical Summary
Cluster headache (CH) is a rare and disabling primary headache disorder characterized by episodic attacks of intense unilateral headache and autonomic symptoms. Cluster periods are separated by attack-free remissions of variable duration, lasting from weeks to years. The average age of onset is 20-40 years and there is a strong male predominance. The rarity of CH, the severity of the illness and the varying patterns of bouts mean that reported estimates of disease prevalence lack precision. The primary objective of this study is to determine a prevalence estimate of cluster headache in adults and children, and to describe the characteristics of CH patients.
Lilly is developing a Calcitonin Gene Related Peptide neutralising Antibody (CGRP Ab) for the preventive treatment of CH. Preventive treatment is initiated at the onset of a cluster period but aimed at reducing the overall number of cluster attacks during the cluster period. This analysis will also examine the prevalence of use of CH treatments, with a focus on preventive treatments. This data will be used to provide epidemiological data for submission to regulatory authorities.
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Use of COX-2 inhibitors and risk of glioma — Christoph Meier ...
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Use of COX-2 inhibitors and risk of glioma
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-04
Organisations:
Christoph Meier - Chief Investigator - University of Basel
Claudia Becker - Collaborator - University of Basel
Corinna Seliger - Collaborator - University of Regensburg
Michael Leitzmann - Collaborator - University of Regensburg
Peter Hau - Collaborator - University of Regensburg
Susan Jick - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Ulrich Bogdahn - Collaborator - University of RegensburgOutcomes: none known
Description: Technical Summary
We propose to conduct a 1:10 matched case-control analysis using the CPRD to test the hypothesis that use of COX-2 inhibitors is associated with decreased risk of glioma. We will conduct conditional logistic regression analyses to determine relative risks, estimated as odds ratios (ORs) with 95% confidence intervals (CIs) of glioma in relation to use of COX-2 inhibitors. Analyses will be adjusted for various potential confounding variables and only variables altering the risk of glioma by >10% will be included in the final multivariate analysis. The effects of exposure to COX-2 inhibitors will be compared to the effects of other non-selective NSAIDs (diclofenac, ibuprofen, naproxen, and aspirin) and non-NSAID analgesics (paracetamol, opioids). We will shift the date of diagnosis backward in time by one year for cases and controls. Missing data will be included in a separate category in the logistic regression model.
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Risk of fragility fracture across inflammatory conditions: a UK population study — Christian Mallen ...
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Risk of fragility fracture across inflammatory conditions: a UK population study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-17
Organisations:
Christian Mallen - Chief Investigator - Keele University
Zoe Paskins - Corresponding Applicant - Keele University
Edward Roddy - Collaborator - Not from an Organisation
Milica Bucknall - Collaborator - Keele University
Rebecca Whittle - Collaborator - Keele University
Samantha Hider - Collaborator - Keele UniversityOutcomes: none known
Description: Technical Summary
Background: Inflammatory conditions such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD) and systemic lupus erythematous (SLE) are known to be associated with increased risk of osteoporosis and fracture. However, previous estimates of fracture risk may be outdated, especially given recent improvements in the management of these conditions. Furthermore, for common inflammatory conditions (polymyalgia rheumatica (PMR), giant cell arteritis (GCA), psoriasis and gout) limited epidemiological evidence about fracture risk exists. Primary aim: To estimate the relative effect of selected inflammatory conditions (RA, AS, SLE, IBD, gout, PMR, GCA, psoriasis) on the risk of osteoporosis and fragility fracture. Methods: A retrospective matched cohort study utilizing data from Clinical Practice Research Datalink (CPRD). Exposed individuals will be those with diagnoses of RA, AS, SLE, IBD, gout, PMR and psoriasis from 1990-2004. Incidence rates of fragility fracture and osteoporosis over 10 years of follow up will be calculated and compared in each disease group. Expected outputs and future developments: The results will impact on clinical practice by enabling screening to be targeted at those conditions with highest risk and enable accurate fracture risk estimation. The results will be presented at national and international conferences, published in high-impact medical journals, and inform (inter)national clinical guidelines.
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Estimating the prevalence of myasthenia gravis and neuromyelitis optica through the Clinical Practice Research Datalink — Christopher Morgan ...
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Estimating the prevalence of myasthenia gravis and neuromyelitis optica through the Clinical Practice Research Datalink
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-17
Organisations:
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Alexander Cole - Collaborator - Alexion Pharmaceuticals
Bethan Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data SciencesOutcomes: none known
Description: Technical Summary
We aim to estimate the overall and age and gender-specific incidence and prevalence of myasthenia gravis (MG) and neuromyelitis optica (NMO) in a UK population based on the Clinical Practice Research Datalink (CPRD). In addition to the overall rates we also wish to estimate age- and gender-specific rates and to calculate age of onset. To achieve this we will use primary-care data from CPRD GOLD for the main analysis, but in a sensitivity analysis we will combine this with secondary-care data from the linked Hospital Episode Statistics (HES). Patients will be identified by Read code and the ICD-10 classification as appropriate. Period prevalence will be calculated for 2014, using the number of live patients registered within an up-to-standard (UTS) practice on the mid-year point (30th June 2014) as the denominator. Annual incidence will be estimated based on average annual incidence observed since 2000.
A second sensitivity analysis for MG will be presented for those cases defined as probable cases.
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Resource use associated with Idiopathic Pulmonary Fibrosis — Irwin Tran ...
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Resource use associated with Idiopathic Pulmonary Fibrosis
Datasets:GP data, HES Admitted Patient Care; HES Outpatient
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-16
Organisations:
Irwin Tran - Chief Investigator - Roche
Jamie Garside - Collaborator - Roche
Mike Storm - Collaborator - Information Handling Services (IHS) Inc.
Robert Heathcote - Collaborator - Roche
Shadi Afzalnia - Collaborator - RocheOutcomes: none known
Description: Technical Summary
Descriptive statistics and econometric analyses will be performed on the data to examine and explain the relationships between patient variables (such as demographics, disease severity, time since diagnosis, etc.) and NHS resource use.
The main analyses will consist of descriptive statistics and regression analysis to understand the incidence, prevalence, morbidity, and mortality associated with IPF. Resource use for both inpatient (number of stays, length of stay, etc.) and outpatient (general practitioner [GP] visits, emergency department visits, outpatient hospital visits, etc.) will subsequently be estimated both for those with and without IPF. This will consist of analysis of the GOLD dataset and the linked inpatient and outpatient HES files.
Subsequent analyses will scale these relationships up to the entire population served by the NHS and will incorporate cost estimates from published literature (the PSSRU) to estimate the annual monetary costs of IPF. If possible, a broader societal cost estimate will be undertaken via indirect cost estimates (missed workdays and labour force exit due to illness, informal caregiver needs, etc.) will also be incorporated, as would quality of life (via published EQ-5D catalogues). These will leverage the findings of the analyses of CPRD data, combining them with previously published data sources.
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Mortality of people with learning disability — Gyles Glover ...
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Mortality of people with learning disability
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-11
Organisations:
Gyles Glover - Chief Investigator - Public Health England
Jessie Oyinlola - Collaborator - CPRD
Pauline Heslop - Collaborator - University of Bristol
Rachael Williams - Collaborator - CPRDOutcomes: none known
Description: Technical Summary
This study will use CPRD linked primary care, death certificate and inpatient hospital data to develop indicative statistics about likely levels and patterns of excess mortality identifiable, "near miss" emergency hospitalisations, and the extent of hospital inpatient care, for people recorded as having learning disabilities in their GP records and a control population who do not between April 2010 and March 2014. Aggregate data will be provided by CPRD to PHE for the purposes of calculating standard mortality rates (all-cause and cause-specific), life expectancy, and person years of life lost to amenable causes. Additionally, rates of emergency hospitalisations for potentially fatal conditions particularly prominent in people with learning disabilities will be calculated. The duration of hospitalisations will also be calculated.
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Demographic and clinical characteristics of T2DM patients treated with DPP-4 and SGLT2 inhibitors in the absence of a current clinical guideline - A CPRD Study — Sally Lee ...
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Demographic and clinical characteristics of T2DM patients treated with DPP-4 and SGLT2 inhibitors in the absence of a current clinical guideline - A CPRD Study
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-27
Organisations:
Sally Lee - Chief Investigator - Celgene Ltd
Sally Lee - Corresponding Applicant - Celgene Ltd
Anna Scowcroft - Collaborator - UCB Pharma Ltd
Antonio Ruffolo - Collaborator - Boehringer-Ingelheim International GmbH
John Bolodeoku - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Paula Bingham-Gardiner - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Prashanth Kandaswamy - Collaborator - Boehringer-Ingelheim International GmbH
Syed Wasi Hassan - Collaborator - Eli Lilly & Co Ltd - US Headquarters
William Henry Fitzgerald Spencer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, IncOutcomes: none known
Description: Technical Summary
The primary objective of this study is to understand the usage of newer agents for the treatment of T2DM, namely DPP-4 and SGLT2 inhibitors by describing demographic and clinical characteristics of patients who have been prescribed the medications. Subsequently, medications and doses of DPP-4 inhibitors prescribed to patients with kidney impairment will be analysed. The method of research will be a descriptive cohort. Patients who have had a prescription for DPP-4 or SGLT2 and were 40 years or older when T2DM was diagnosed will form two study cohorts (i.e., DPP-4 population and SGLT2 population). Descriptive statistics will be used to summarise demographic and clinical characteristics of patients who have been treated with either class of glucose-lowering medications. As a subset of the DPP-4 cohort, patients with moderate to severe kidney impairment will form a second part of the study. The medications and doses/dosage of DPP-4 inhibitors prescribed to this patient population will be described.
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Medical resource use and costs associated with diabetes complications in the population of diabetes patients receiving insulin therapy in the United Kingdom — Colin Hopley ...
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Medical resource use and costs associated with diabetes complications in the population of diabetes patients receiving insulin therapy in the United Kingdom
Datasets:GP data, HES Admitted Patient Care; HES Outpatient; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-31
Organisations:
Colin Hopley - Chief Investigator - BD - Becton, Dickinson and Company
Didier Morel - Collaborator - BD - Becton, Dickinson and Company
Grace Vanterpool - Collaborator - Ealing Hospital NHS Trust
Kenneth Strauss - Collaborator - BD - Becton, Dickinson and Company
Peter Davies - Collaborator - Sandwell General HospitalOutcomes: none known
Description: Technical Summary
The objectives of this study are to quantify the clinical outcomes and MRU for diabetics using various insulin delivery systems, and to examine these in important subgroups. Using a retrospective observational design, we will use descriptive analyses to examine demographics and clinical characteristics of the population, multivariate statistics to examine the MRU and costs, and multivariate Poisson regression to determine factors associated with diabetes complications. The outcomes will also be examined within subgroups of patients to determine how they differ by important subpopulations potentially at higher risk for increased MRU, costs, and more frequently-occurring complications.
Source - and 2 more projects — click to show
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Alcohol misuse and injury outcomes in adolescents aged 10-24 using linked UK health data — Elizabeth Orton ...
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Alcohol misuse and injury outcomes in adolescents aged 10-24 using linked UK health data
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-16
Organisations:
Elizabeth Orton - Chief Investigator - University of Nottingham
Louise Lester - Corresponding Applicant - University of Nottingham
Ruth Baker - Collaborator - University of NottinghamOutcomes: none known
Description: Technical Summary
Injuries are the leading cause of mortality among young people within the UK, leading to large numbers of hospital admissions every year. Existing studies assessing health outcomes of hazardous or harmful alcohol consumption are often limited by small sample sizes, being cross-sectional, and relying on self-reported alcohol intake and outcome information. There are few population-based studies of alcohol-related health outcomes among young people; none using linked primary and secondary care data in the UK. Using a cohort aged 10-24 with linked CPRD and inpatient HES data, for the period 1997-2014, we will assess whether young people with an alcohol-specific hospital admission have a higher risk of injury than controls. We will match up to 10 controls (without an alcohol-specific hospital admission between age 10-24) per case on age and general practice. We will estimate incidence rates, unadjusted and adjusted hazard rate ratios of injury and 95% confidence intervals using Cox regression to compare those with and without an alcohol-specific hospital admission. Age, sex, region, calendar year and socioeconomic status will be investigated as potential confounders. A greater understanding of injury consequences among young people who misuse alcohol will help develop more targeted and evidence based prevention and harm minimisation programmes.
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Characteristics of newly diagnosed adults with Type 1 diabetes in the UK and their evolution over the first 5 years — Shenaz Ramtoola ...
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Characteristics of newly diagnosed adults with Type 1 diabetes in the UK and their evolution over the first 5 years
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-08-27
Organisations:
Shenaz Ramtoola - Chief Investigator - NHS
Uffe Jon Plough - Corresponding Applicant - Novo Nordisk
Martin-Erik Nyeland - Collaborator - Leo Pharma A/S
Nana Kragh - Collaborator - Novo NordiskOutcomes: none known
Description: Technical Summary
The study aims to describe the clinical profile of people newly diagnosed with Type 1 Diabetes Mellitus at time of diagnosis, following the first five years of treatment with insulin and as a comparison to a general population as described in the Health Survey of England.
Patient demographics, baseline characteristics and measurements after 1, 2, 3 and 5 years, will be analyzed and presented as mean, standard deviation, range and/or mode and interquartile range for continuous variables as appropriate and as count and percent (N, %) for categorical variables.
Source
2015 - 07
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To establish the causal roles of environmental factors on exacerbations of COPD — Jennifer Quint ...
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To establish the causal roles of environmental factors on exacerbations of COPD
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-07-16
Organisations:
Jennifer Quint - Chief Investigator - Imperial College London
Antonis Kousoulis - Collaborator - Mental Health Foundation
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Miland Joshi - Collaborator - Imperial College LondonOutcomes: none known
Description: Technical Summary
1. Objectives
To find evidence supporting the hypothesis that increased levels of common atmospheric pollutants or falls/rises in temperature cause an increased risk and hence incidence of execerbations of COPD.2. Methods
We will link patient data via General Practices contributing to CPRD to relevant atmospheric data held by DEFRA and BADC. As the best available proxy for environmental data in the locality of a given practice we will use data from the nearest monitoring station, found by translating post codes into British National Grid coordinates.3. Data analysis
Poisson regression will be used to model the incidence and the relative risk of the occurrence of exacerbations of COPD using as explanatory variables the levels of pollutants, temperature and any relevant medical explanatory variables.
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Characterising the natural history and risk factors for the development of psoriatic arthritis in a UK population — Rachel Charlton ...
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Characterising the natural history and risk factors for the development of psoriatic arthritis in a UK population
Datasets:GP data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-07-30
Organisations:
Rachel Charlton - Chief Investigator - University of Bath
Rachel Charlton - Corresponding Applicant - University of Bath
Alison Nightingale - Collaborator - University of Bath
Gavin Shaddick - Collaborator - University of Bath
Laura Bojke - Collaborator - University of York
Neil McHugh - Collaborator - University of BathOutcomes: none known
Description: Technical Summary
This study forms part of a wider NIHR funded Programme Grant (RP-PG-1212-20007) on the impact of early diagnosis of PsA. The proposed study aims to describe the incidence, prevalence and evolution of musculoskeletal symptoms reported to general practitioners by people with psoriasis in UK primary care and investigate predictors of the development of PsA in people with psoriasis, such as obesity and smoking. The study will follow a cohort study design and identify cases of psoriasis and PsA in the Clinical Practice Research Datalink, between 01/01/1998 and 31/12/2014, and follow them prospectively until the end of the study period or the time they leave the database. The incidence and prevalence of musculoskeletal symptoms will be calculated for each year after entry into the study period stratified by age, sex and psoriasis disease severity and survival rates from musculoskeletal symptom presentation to PsA diagnosis will be calculated. Generalised linear models with time varying covariates will be used to investigate factors associated with the development of PsA. Additionally, co-morbidity in PsA and the utilisation of primary health care resources before and after PsA diagnosis will be described to inform the cost-effectiveness component of the wider Programme Grant.
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Chief Medical Officer Annual Report — Edward Mullins ...
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Chief Medical Officer Annual Report
Datasets:GP data, ONS Death Registration Data
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-07-15
Organisations:
Edward Mullins - Chief Investigator - Department of Health
Tarita Murray-Thomas - Corresponding Applicant - CPRD
Jennifer Campbell - Collaborator - CPRDOutcomes: none known
Description: Technical Summary
The Chief Medical Officer (CMO) Report provides an assessment of the state of the publicâs health and advises government on where action may be required. Data and information that describes the health of the population is essential to the report, particularly data highlighting current trends in the health issues to be covered by the report, over time. Such data are often available from published sources but from time to time may be generated, on an ad-hoc basis, where there is a paucity of information in specific areas. The 2014 annual report relates to Women's Health in England. CPRD data will be used to generate select aggregated output and basic descriptive statistics to support several chapters of the report. Rates will be presented with their 95% confidence interval where applicable, and tests for trend over time will be evaluated.
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The effect of metformin on patient outcome after acute myocardial infarction — Derek Yellon ...
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The effect of metformin on patient outcome after acute myocardial infarction
Datasets:GP data, HES Admitted Patient Care; ONS Death Registration Data; Patient Level Index of Multiple Deprivation; Patient Level Townsend Score; Practice Level Index of Multiple Deprivation; MINAP
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-07-22
Organisations:
Derek Yellon - Chief Investigator - University College London ( UCL )
Daniel Bromage - Corresponding Applicant - King's College London (KCL)
Emily Herrett - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Harry Hemingway - Collaborator - University College London ( UCL )
Mar Pujades Rodriguez - Collaborator - University of Leeds
Xavier Rossello Lozano - Collaborator - University College London ( UCL )Outcomes: none known
Description: Technical Summary
The objective of the proposed research is to investigate the effect of preadmission and subsequent metformin on outcomes after acute myocardial infarction (AMI) in type 2 diabetics using CPRD data linked with the national audit of myocardial infarction (MINAP), Office for National Statistics (ONS) mortality data and hospital episode statistics (HES) data through the CALIBER dataset.
This is a prospective cohort study of patients with type 2 diabetes experiencing their first AMI, comparing patients with a prescription of metformin (or metformin and other oral anti-diabetic agents) versus alternative oral anti-diabetic medication without metformin prior to, and after, index AMI. Patients will be compared with respect to primary outcomes of major adverse cardiac events (a composite of cardiovascular death, acute coronary syndrome requiring hospitalisation, and stroke), heart failure and all-cause mortality.
The absolute incidence of AMI, demographic and baseline characteristics of the study population with or without metformin will be compared using the Pearson Chi Square test for categorical variables and Student t test for continuous variables.
We will calculate Kaplan-Meier product limits for cumulative probability of reaching an end point and use the log rank test for evidence of a significant difference between groups. Cox regression analysis will be used to estimate hazard ratios for the effect of metformin in fully adjusted models.
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Creation of a model of GP workload in terms of patient, practice and geographical variables to inform the GMS Contract Formula — Lindsay Gardiner ...
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Creation of a model of GP workload in terms of patient, practice and geographical variables to inform the GMS Contract Formula
Datasets:GP data, HES Admitted Patient Care; Patient Level Index of Multiple Deprivation; Practice Level Index of Multiple Deprivation; Other
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-07-20
Organisations:
Lindsay Gardiner - Chief Investigator - NHS
Tarita Murray-Thomas - Corresponding Applicant - CPRD
David Vincent - Collaborator - Deloitte LLP
Hugh Gravelle - Collaborator - University of York
Katherine Everard - Collaborator - NHS
Samuel Beatson - Collaborator - NHSOutcomes: none known
Description: Technical Summary
The purpose of this research is to inform a review of the General Medical Services (GMS) contract formula in England. The current contract includes a formula (the âCarr-Hillâ formula) designed to reflect workload at practice level. This formula is now recognised to be out of date as the nature of General Practice (GP) workload has changed since this was developed. The proposed research will produce a new model measured either by total âcase openingâ time or ânumber of file openingsâ and will include age, sex, new registrations and deprivation, alongside practice characteristics such as QOF disease prevalence as explanatory variables in the new workload formula. Generalised linear models will be developed to model the relationship between case opening times and model parameters in a training dataset. The final model will be evaluated in a test and independent dataset. The GP workload formula will be combined with a formula for cost (developed in a separate non-CPRD study) to inform both CCG level primary care resource allocation and resource allocation for each GMS practice.
The expectation is that the new formula will better allocate resources to CCGs and practices to better meet need across primary care, benefitting patients across the whole system.
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The impact of obesity on healthcare resource utilisation. — Anders Rething Borglykke ...
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The impact of obesity on healthcare resource utilisation.
Datasets:GP data, HES Admitted Patient Care
Processing Environment: disseminated dangerously
TRE: Optional and unpublished
Accreditation Date: 2015-07-14
Organisations:
Anders Rething Borglykke - Chief Investigator - Novo Nordisk
Anders Rething Borglykke - Corresponding Applicant - Novo Nordisk
Anne Helene Olsen - Collaborator - Novo Nordisk
Bine Kjoller Bjerregaard - Collaborator - Novo NordiskOutcomes: none known
Description: Technical Summary
Overweight and obesity have been found to be associated with several diseases such as diabetes, cardiovascular diseases and certain types of cancer. Furthermore obese patients more frequently experience non-life threatening disease like osteoarthritis and other musculoskeletal diseases. This study seeks to examine whether the increased disease frequency in obese patients compared to non-obese patients results in an increased healthcare resource utilisation defined as higher rates of GP contacts, use of prescription medication or hospital admission.
The cohort consists of patients registered in the CPRD who have a current registration date prior to 01.01.2010 and acceptable data as defined by CPRD. Each patient is followed from an individual baseline (latest date of BMI measurement between 01.01.2008 and 01.01.2010 or 01.01.2009 if no BMI is registered within this period) until end of follow-up (minimum of death date, transfer out date or 30.09.2014). Patients below 18 years of age at baseline are excluded. Rates of the three endpoints are calculated and the rates for obese and non-obese patients are compared using Poisson regression analysis. Sensitivity analyses concerning the group of patients without a registered BMI will be performed.
Source
1900 - 00
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Predictors of hospitalisation in the last months of life for people with cancer: retrospective cohort study using linked data — Hillingdon Hospital Trust Chelsea CWHT...
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Predictors of hospitalisation in the last months of life for people with cancer: retrospective cohort study using linked data
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: missing
Opt Outs: no information provided./p>
Organisations: Hillingdon Hospital Trust Chelsea CWHT
Description: End of Life Care and Cancer. Academic
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WSIC Methodology paper — Imperial College...
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WSIC Methodology paper
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: missing
Opt Outs: no information provided./p>
Organisations: Imperial College
Description: All conditions/population in WSIC. Academic
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To study the journey of patients 12 months prior to liver disease admission across the whole integrated system — Imperial College Healthcare NHS Trust...
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To study the journey of patients 12 months prior to liver disease admission across the whole integrated system
Legal basis:Retrospective analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: missing
Opt Outs: no information provided./p>
Organisations: Imperial College Healthcare NHS Trust
Description: Liver Disease – alcoholic steatohepatitis (ASH). Academic
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missing — missing...
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missing
Legal basis:missing
Datasets:kept secret
Processing Environment: kept secret
Approved Date: missing
Opt Outs: no information provided./p>
Organisations: missing
Description: missing.
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Study investigating bariatric surgery patients who have completed psychological questionnaires — West London Mental Health NHS Trust...
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Study investigating bariatric surgery patients who have completed psychological questionnaires
Legal basis:Cohort recruitment analysis
Datasets:kept secret
Processing Environment: kept secret
Approved Date: missing
Opt Outs: no information provided./p>
Organisations: West London Mental Health NHS Trust
Description: Mental Health and Bariatrics. Academic
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ID-376: Pan-London Major Trauma Psychology Service Evaluation — West London NHS Trust...
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ID-376: Pan-London Major Trauma Psychology Service Evaluation
Legal basis:Service Evaluation
Datasets:kept secret
Processing Environment: kept secret
Approved Date: missing
Opt Outs: no information provided./p>
Organisations: West London NHS Trust
Description: Major trauma.
Source
Notes
The data in this list is accurate for NHS Digital disseminations from mid-2018; Cancer Registry data is missing, but will appear as and when it is incorporated into NHS Digital's data usage register. CPRD keeps projects secret for three (or more) months; QResearch, TPP ResearchOne, and some other GP data-related datasets are also missing. Some unusual COVID-19 purposes are missing due to different IG rules, but these could be added in the medium term.
For the purposes of this list, surveys by ONS are considered to have respected individual choice — as are NHS projects that have received Section 251 support. Administrative datasets, such as the National Pupil Database, are considered not to have respected choice, on the basis that good information from the data controllers is still lacking. The position as regards CPRD is unclear.
N.B. It is possible for a project to receive data that both respects some choices and ignores others. In such cases, unticking either or both of the consent/dissent related boxes will not exclude the project from the list.